Abstract:
A pliable band or hoop that is flexible to normal handling, but cannot stretch circumferentially once it has reached the limits of its circumferential length. The band may have a structural portal to be used for filling, or it may simply be constructed of a fabric-like material that allows a fill tube to perforate its walls to allow for filling. In the latter case, the perforated wall tends to self-seal once the fill tube is withdrawn. The band may be flat or tubular in cross-section. However, unlike a balloon, the band does not require either a bottom or a top, as we found that a top and bottom are unnecessary when using a band or hoop to enclose material injected into a reamed out intervertebral space.

Description:
PRIORITY 
       [0001]    This application is a divisional application of U.S. application Ser. No. 12/894,106, filed Sep. 29, 2010, which is a continuation application of U.S. application Ser. No. 11/752,059, filed May 22, 2007, which is a continuation application of U.S. application Ser. No. 11/447,615 filed Jun. 6, 2006, now U.S. Pat. No. 7,220,282, which is a continuation application of U.S. application Ser. No. 10/812,345 filed Mar. 29, 2004, now U.S. Pat. No. 7,056,345, which is a continuation application of U.S. application Ser. No. 10/022,048 filed Dec. 17, 2001, now U.S. Pat. No. 6,712,853, which claims priority from U.S. Provisional Application No. 60/256,014, filed Dec. 15, 2000, the entire contents of the foregoing are hereby incorporated herein by reference. 
     
    
     FIELD 
       [0002]    This invention relates to devices that provide a means to support and/or reinforce and/or stabilize a diseased mammalian spinal intervertebral disc. 
       BACKGROUND 
       [0003]    It is recognized that the spinal disc consists of three parts: first, the nucleus, a central portion that is a compression-resisting cushion; second, the annulus, a peripheral rim portion that is a tension-resisting hoop; and third, the end plate, the superior and inferior borders of the disc, consisting of the up and down borders of the vertebral body bones. 
         [0004]    Many studies have concluded that mechanical back pain is the most common and costly musculoskeletal condition affecting middle-aged humans in modem societies. Mechanical back pain may be caused by several factors, but overwhelming evidence suggests that degeneration of the spinal intervertebral disc, such as may be caused by Degenerative Disc Disease (DDD) is the most common condition causing back pain symptoms. 
         [0005]    The inventor, in a previously published work entitled the tissue origin of low back pain and sciatica: A report of pain response to tissue stimulation during operations on the lumbar spine using local anesthesia. (Orthop. Clin. North Amer. 1991; 22(2):181-187.), demonstrated that the diseased disc rim or annulus is the principle pain generator responsible for mechanical back pain. 
         [0006]    Many devices have been invented for the purpose of stabilizing and/or replacing parts of the disc in an effort to ease the pain associated with disc disease. Indeed, one of the author&#39;s prior inventions, the BAK has been used in more than 80,000 humans, with generally good results (See generally: the Bagby and Kuslich Method of Lumbar Interbody Fusion. History, Techniques, and 2-year Follow-up Results of a United States Prospective, Multicenter Trial. Kuslich S. D., Ulstrom C. L., Griffith S. L., Ahem J. W., Dowdle J. D., Spine 1998; 23:1267-1279; Summary of Safety and Effectiveness Of the BAK Interbody Fusion System, Food and Drug Administration (FDA) (PMA 950002), PMA Document Mail Center (HFZ-401), Center for Disease and Radiological Health, Washington D.C., Sep. 20, 1996; and Lumbar Interbody Cage Fusion for Back Pain: an Update on The BAK (Bagby and Kuslich) System, Kuslich S. D., Spine: State of the Art Reviews 1999; 13(2):295-311). Unfortunately, the BAK and many similarly structured rigid metallic implants suffer from several less than ideal features such as: the need to create fairly large surgical exposures, the need for fairly large entrance holes through the annulus of the disc, and the presence of fairly large volumes of metal that reduce bone graft surface contact at the end plate. 
         [0007]    Any device that would more easily, and/or more effectively, and/or more safely treat degenerative disc disease would be useful in the management of hundreds of thousands of suffering individuals. 
         [0008]    Previous patents involving intervertebral devices designed to treat DDD fall generally into the following four classes: 
         [0009]    The first class includes rigid, three-dimensional geometric solid devices, either impervious or porous, that function as support struts. When placed in the area of the disc between adjacent vertebral bodies, they allow and/or encourage bone to grow through and/or around the device to cause a bony fusion between two adjacent vertebral bodies. Examples of such devices have been described in the following references: 
         [0010]    U.S. Pat. No. 6,015,436 to Schonhoffer 
         [0011]    U.S. Pat. No. 6,010,502 to Bagby 
         [0012]    U.S. Pat. No. 5,972,031 to Biedermann et al. 
         [0013]    U.S. Pat. No. 5,895,427 to Kuslich 
         [0014]    U.S. Pat. No. 5,735,899 to Schwartz et al. 
         [0015]    U.S. Pat. No. 5,720,748 to Kuslich 
         [0016]    U.S. Pat. No. 5,709,683 to Bagby 
         [0017]    U.S. Pat. No. 5,700,291 to Kuslich 
         [0018]    U.S. Pat. No. 5,669,909 to Zdeblick 
         [0019]    U.S. Pat. No. 5,514,180 to Heggeness et al. 
         [0020]    U.S. Pat. No. 5,591,235 to Kuslich 
         [0021]    U.S. Pat. No. 5,489,308 to Kuslich 
         [0022]    U.S. Pat. No. 5,489,307 to Kuslich 
         [0023]    U.S. Pat. No. 5,405,391 to Henderson et al. 
         [0024]    U.S. Pat. No. 5,263,953 to Bagby 
         [0025]    U.S. Pat. No. 5,059,193 to Kuslich 
         [0026]    U.S. Pat. No. 5,015,255 to Kuslich 
         [0027]    U.S. Pat. No. 5,015,247 to Michelson 
         [0028]    U.S. Pat. No. 4,946,458 to Harms et al. 
         [0029]    U.S. Pat. No. 4,936,848 to Bagby 
         [0030]    U.S. Pat. No. 4,834,757 to Bantigan 
         [0031]    U.S. Pat. No. 4,820,305 both to Harms et al. 
         [0032]    U.S. Pat. No. 4,501,269 to Bagby 
         [0033]    U.S. Pat. No. 4,401,112 to Rezaian 
         [0034]    The second class involves the use of semi-rigid artificial joints that allow motion in one or more planes. Examples include U.S. Pat. No. 4,759,769 to Kostuik, U.S. Pat. No. 6,039,763 to Shelokov, and commercially available examples such as the Link device or Charite Intervertebral Disc Endoprosthesis. 
         [0035]    The third class is directed to non-rigid cushions designed to replace the nucleus of the disc. Examples of artificial discs are described in U.S. Pat. No. 4,904,260 to Ray, U.S. Pat. No. 4,772,287 to Ray and U.S. Pat. No. 5,192,326 to Boa. 
         [0036]    Finally, the fourth class is the relatively new area of initially flexible, expandable bags or balloons that become rigid when injected with materials that can support loads. Examples include U.S. Pat. Nos. 5,571,189 and 5,549,679 to Kuslich, each of which describe expandable, porous balloons or bags, useful in stabilizing a deteriorating spinal disc. In this fourth class, a porous bag or balloon is used which is closed except for a mouth through which bone graft or other graft material is inserted. The bag is placed into a reamed out intervertebral space and is expanded by the introduction of graft material. Recent research and development in the inventor&#39;s laboratory established the fact that a thin walled band or hoop, either porous or non-porous, can be placed in the region of the annulus by means of several techniques. Such a band or bands as described in detail below effectively reinforce the annulus and thereby support spinal motion segment strain deflections resulting from stresses applied in all vector directions: rotation, flexion-extension, side bending, compression and distraction. Furthermore, the inventor&#39;s experiments show that these radially applied bands or hoops can effectively contain and retain inserted or injected materials that are placed in the central region of a reamed-out disc. 
         [0037]    The current invention teaches a technique for building and using a simple band to perform many of the functions of the prior art described above. For instance, if compared to metal cylindrical implants such as described in U.S. Pat. No. 5,015,247 to Michelson and metal-walled or plastic-walled rectangular shaped implants such as may be described in U.S. Pat. Nos. 4,878,915 and 4,743,256 both to Brantigan, the bands of this invention are softer, lighter, more pliable, and without hard sharp edges, thereby offering greater safety during passage next to delicate structures such as the great vessels or the spinal cord. Also, the completely open structure at the Polar Regions adjacent to cancellous bone of the vertebral bodies, would allow for a more intimate fit between inserted graft material and living bone. This intimacy of contact, without any intervening implant material, may reasonably lead to a faster and more complete biological ingrowth through the central portion of the implant. 
         [0038]    It is well known that greater surface area contact between graft and living bone is conducive to higher fusion rates and conversely, lower non-union rates. Thus, the current invention provides for several unique advantages over prior art in the field of interbody fusion devices. 
         [0039]    In addition to its uses and advantages in the form of improved interbody fusion devices, the attributes of the current invention would provide a new and potentially superior technology in two other categories of treatment for degenerative disc disease: one, soft tissue reinforcement of diseased discs, and two, disc replacement. 
         [0040]    In regard to soft tissue reinforcement of diseased discs, several new techniques have recently become available to treat early and mid-stage disc degeneration by methods less invasive and less drastic than fusion surgery. Examples include: annular tissue modulation by heat application (See generally: Saal J. et al. North American Spine Society presentations 1999, 2000); the use of a polyester tension band placed around and between pedicle screws above and below the involved disc such as, described in U.S. Pat. No. 5,092,266 to Graf; and combined tension and distraction devices placed between pedicle screws, such as may be seen in the commercially available DyneSyS™ device from Sulzer Orthopedics Ltd. While early results from the above technologies appear promising, the current invention would obviate some of the potential dangers and drawbacks of these systems. For example: 
         [0041]    In the case of annular tissue modulation by heat application, the current invention does not require heat. Heat can be injurious to local spinal nerves and vessels, possibly leading to paralysis or even death by hemorrhage. The current invention immediately stabilizes the annulus, rather than having to wait until the heat-damaged tissue heals and shrinks. 
         [0042]    In the case of a polymeric tension band placed between pedicle screws above and below the involved disc, the current invention does not require the placement of pedicle screws. The placement of pedicle screws requires a significant surgical exposure with attendant bleeding and injury to local muscular, ligamentous, vascular and nervous tissues. The current invention can be installed through much smaller, microsurgical exposures that would have less likelihood of causing collateral damage. 
         [0043]    In the case of combined tension and distraction devices placed between pedicle screws, the current invention directly stabilizes the very tissue that is causing the discogenic pain, the annulus, rather than attempting to stabilize the annulus by an external, cantilevered system that has all of the risks and disadvantages of using polyester tension bands and pedicle screws. 
         [0044]    The current invention is a basic departure from the prior art at a very fundamental level. The core element of the invention is the simple but broad concept of applying a tension-resisting circumferential band at or near the mid or outer circumference of the annulus. A careful review of the patent and medical literature and prior art did not provide an instance of this fundamental concept having been previously described. Once conceived, the core idea of using a circumferential tension band to reinforce an injured disc annulus led to a number of alternative embodiments, spanning the treatment options all the way from simple reinforcement, to containment of graft material for interbody fusion, to radial containment of a centrally placed compressible or incompressible nuclear replacement material. In other words, the basic concept of the current invention could provide the critical element that would allow a developer and/or a surgeon a new means to structure a new and potentially better annular support for a less invasive early to mid-stage degenerative disc disease treatment method. The invention would also provide an improved means of graft support for a less invasive interbody fusion method. Finally, the invention would provide an improved means of support for nuclear material (biological or non-biological, bioactive or inert, hydrophilic or non-hydrophilic, granular or amorphous)—for nuclear replacement or so-called artificial disc replacement. 
         [0045]    The entire content of each and all patents, patent applications, articles and additional references, mentioned herein, are respectively incorporated herein by reference. 
         [0046]    The art described in this section is not intended to constitute an admission that any patent, publication or other information referred to herein is “prior art” with respect to this invention, unless specifically designated as such. In addition, this section should not be construed to mean that a search has been made or that no other pertinent information as defined in 37 C.F.R. .sctn. 1.56(a) exists. 
       SUMMARY 
       [0047]    The invention provides for an expandable tubular member or band which has side walls and may include a fill opening. However, the expandable band does not require either a bottom or a top as it has been found that a suitable enclosure is created by placing such a band within a reamed out intervertebral space. Pressure within the interior of the band is exerted primarily against the side walls and the adjacent vertebrae surfaces. The pressure exerted by the bone graft material at the top and bottom is exerted against the exposed bone of the adjacent vertebrae which encourages bone growth through the band interior. The bone graft material is contained within the tube by a combination of the natural bony top and bottom together with the sidewall of the band. 
         [0048]    The current invention provides a novel means to support the diseased and/or weakened annulus of the disc. This support would offer improved resistance to stresses placed on the spine and therefore would reasonably result in decreased pain and improved function to any individual suffering from the degenerated disc disease condition. 
         [0049]    In addition to simply reinforcing the diseased annulus of the disc, the devices based on the invention herein described could also provide a means to retain and contain materials that might be inserted or injected into the disc in an attempt to heal the annulus, to replace the natural nucleus, or to create a bony fusion between the two adjacent vertebral bodies. 
         [0050]    In at least one embodiment of the invention, the invention provides a flexible implant that may be inserted into a cavity formed in a degenerating disc. The flexibility of the band allows it to be inserted through a relatively small opening in a disc or vertebral space. The band is then positioned so its fill opening, if any, may receive biological fill material. This material is packed into the interior flexible band, causing the band to expand and conform to the cavity formed in the disc or vertebrae. Fill material is added until enough material is present to expand the disc to the desired position. At this time, the band fill opening is closed to prevent egress of the fill material. 
         [0051]    In at least one embodiment of the invention, the invention provides for a pliable band or hoop that is flexible to normal handling, but cannot stretch circumferentially once it has reached the limits of its circumferential length. The band may have a structural portal to be used for filling, or it may simply be constructed of a fabric-like material that allows a fill tube to perforate its walls to allow for filling. In the latter case, the perforated wall tends to self-seal once the fill tube is withdrawn. The band may be flat or tubular in cross-section. However, unlike a balloon, the band does not require either a bottom or a top, as we found that a top and bottom are unnecessary when using a band or hoop to enclose material injected into a reamed out intervertebral space. 
         [0052]    As long as the width of the band is approximately equal to the annulus height (or stated another way, the distance from one vertebral peripheral end-plate to its neighbor) the band serves well to contain particulate material inserted into the center of the disc cavity, without the need for a complete spherical enclosure, as would be provided by a balloon. Since in the case of the reamed out interdiscal cavity, the top opening and bottom opening of the band would be covered by dense vertebral bone, it is not necessary to enclose inserted particulate graft or other material in these regions. 
         [0053]    Pressure within the cavity, as would occur when a surgeon injects material into its central region interior to the band, is exerted radially against the band and the adjacent vertebral surfaces. As the internal cavity is filled with incompressible material, such as bone graft or bioceramic beads or granules, radial displacement beyond the circumference of the band is restricted. Therefore, any additional injected material would be directed north and south against the vertebral bodies. This action would increase the distance between the vertebral bodies, and produce a so-called disc distraction. This distraction is known to have three salutary results. First, it stabilizes the motion segment by tightening the ligamentous structures. Second, it opens the exiting holes for spinal nerves -the so-called neural foramina- and thus relieves certain types of nerve compression disorders. Third, this improved stability is necessary to allow for bony ingrowth and through-growth, to produce an interbody fusion. The pressure exerted by the bone graft material at the top and bottom is directed against the exposed bone of the adjacent vertebra. This produces an intimate contact that encourages bone growth through the interior of the cavity. 
         [0054]    In at least one embodiment, the invention consists of any continuous band or ring that would be placed around and near the outer margin of the intervertebral disc. A suture or preferably a flattened, braided or woven strand or cord, for instance, that was placed circumferentially about a disc and tied to make a tension-resisting ring, would qualify. Modern endoscopic surgical tools, combined with sophisticated surgical navigation systems make this option more practical and safer than would have been possible a few years ago. 
         [0055]    In yet another embodiment, the band would be pre-formed to match the anatomy of the patient. It would also be available in a variety of circumferences, plies, thicknesses, widths (in the superior-inferior dimensions), weave patterns, materials and filament diameters. The band would be flexible enough to fit through a small hole made in the annulus, such as during a routine disc hernia removal operation. After removal of the disc hernia, the surgeon would introduce an expandable reamer and thereby remove the degenerated nucleus, the cartilage end plate, and the inner annulus, leaving the outer annulus intact. Examples of such a procedure and expandable reamers are described in U.S. Pat. No. 5,445,639 to Kuslich et al. and co-pending U.S. Pat. App. Ser. No. 60/182,610 to Kuslich et al., filed Feb. 15, 2000, the entire contents of both being incorporated herein by reference. 
         [0056]    The properly sized band would be pushed through the disc portal, whereupon, owing to its inherent springiness, or as a result of material being injected in the interior of the disc, the hoop or band would expand radially against the outer annulus. Perforating the mesh fabric of the band, by means of a pointed fill tube, would allow the surgeon to fill the cavity with significant pressure using graft material; perhaps by the use of a graft injection system such as described in a co-pending U.S. patent application Ser. No. 09/738,726 filed Dec. 15, 2000 and entitled Tool to Direct Bone Replacement Material, to Kuslich et al., and is a continuation in part application of U.S. patent application Ser. No. 09/608,079 the entire contents of both being incorporated herein by reference. The resulting compressed graft, held from further expansion by the vertebral bone above and below, and the band or hoop radially, would change phase from liquid-like to solid-like, as is known to occur when granular materials are subjected to compression loading (See: Friction in Granular Flows, by H. M. Jaeger, Chu-heng Liu, S. R. Nagel and T. A. Witten, Europhysics Lett. 11, 619 (1990); Granular Solids, Liquids, and Gases, by H. M. Jaeger, S. R. Nagel and R. P. Behringer, Rev. Mod. Phys. 68, 1259 (1996); and IUTAM Symposium on Segregation in Granular Flows (Solid Mechanics and its Applications), Vol. 81, October 2000). This phase change has been observed and scientifically characterized by our laboratory experiments and by the work described in U.S. Pat. No. 5,331,975 to Bonutti (see also Formation of Structural Grafts From Cancellous Bone Fragment, by P. M. Bonutti, M. J. Cremens, and B. J. Miller, Am. J. Ortop. Jul. 27, 1998: 499-502); each of the above references being incorporated in their entirety herein by reference. This phase change would result in a construct that is capable of both stabilizing the motion segment in the short run, and would foster the development of a solid bony fusion over the long run. 
         [0057]    To state the process in another way: the invention provides a pliable implant that may be inserted into a cavity formed in a degenerating disc. The flexibility of the band allows it to be inserted through a relatively small opening in a disc or vertebral space. The band is then positioned so its fill opening may receive fill material. This material is packed into the region interior to the band, causing the band to expand and conform to the cavity formed in the disc or vertebrae. Fill material is added until enough material is present to expand the disc to the desired position. At this time, the band fill opening is closed, or allowed to self-seal to prevent egress of the fill material. 
         [0058]    All US patents and applications and all other published documents mentioned anywhere in this application are incorporated herein by reference in their entirety. 
         [0059]    The invention in various of its embodiment is summarized below. Additional details of the invention and/or additional embodiments of the invention may be found in the Detailed Description of the Invention below. 
         [0060]    The abstract provided herewith is intended to comply with 37 CFR 1.72 and is not intended be used in determining the scope of the claimed invention. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0061]    A detailed description of the invention is hereafter described with specific reference being made to the following drawings. 
           [0062]      FIG. 1  is a perspective view of a first embodiment of the invention;. 
           [0063]      FIG. 2  is a side view of the embodiment of  FIG. 1 . 
           [0064]      FIG. 3  is a top view of the embodiment of  FIG. 1 . 
           [0065]      FIG. 4  is a perspective view of an embodiment of the invention having an elongate fill opening. 
           [0066]      FIG. 5  is a perspective view of an embodiment of the invention as it may appear when used to replace a spinal disc. 
           [0067]      FIG. 6  is a perspective view of an embodiment of the invention wherein the band is a molded material. 
           [0068]      FIG. 7  is a side view of an embodiment of the invention shown in the reduced state within a storage/delivery tool. 
           [0069]      FIG. 8  is a side view of the embodiment shown in  FIG. 7  wherein the inventive band is being removed from the storage/delivery tool. 
           [0070]      FIG. 9  is a perspective view of an embodiment of the invention wherein the inventive band has a woven, double walled configuration. 
           [0071]      FIG. 10  is a perspective cut away view of the embodiment shown in  FIG. 9 . 
           [0072]      FIG. 11  is a perspective view of the embodiment of the invention shown in  FIG. 9  wherein the inventive band further includes latitudinally oriented support bands. 
           [0073]      FIG. 12  is a perspective cut away view of the embodiment shown in  FIG. 11 . 
           [0074]      FIG. 13  is a perspective view of the embodiment of the invention shown in  FIG. 11  wherein the inventive band further includes longitudinally oriented support bands. 
           [0075]      FIG. 14  is a perspective cut away view of the embodiment shown in  FIG. 13 . 
           [0076]      FIG. 15  is a side view of an embodiment of the invention wherein the inventive band has a single walled configuration. 
           [0077]      FIG. 16  is a perspective view of an embodiment of the invention. 
           [0078]      FIG. 17  is a top down view of an embodiment of the invention. 
           [0079]      FIG. 18  is a side view of the embodiment of the invention shown in  FIG. 15  wherein the inventive band is shown is a partially reduced state. 
           [0080]      FIG. 19  is a perspective view of a graft insertion tool suitable for use with the inventive band. 
           [0081]      FIG. 20  is a side view of the tool shown in  FIG. 19 . 
           [0082]      FIG. 21  is a top down view of the tool of  FIG. 19 . 
           [0083]      FIG. 22  is a side view of the tool of  FIG. 19  seen dislocating the fibers of an embodiment of the inventive band. 
           [0084]      FIG. 23  is a top down cut away view of a tool similar to the tool of  FIG. 19  as may be seen during graft insertion. 
           [0085]      FIG. 24  is a perspective view of a portion of a spine wherein an embodiment of the invention is shown in place. 
           [0086]      FIG. 25  is a cross-sectional view of a spinal body which includes an embodiment of the invention therein. 
           [0087]      FIG. 26  is a close-up cut away view of a portion of the embodiment shown in  FIG. 25 . 
           [0088]      FIG. 27  is a cross sectional view of a spinal segment which includes an embodiments of the invention being positioned thereabout. 
           [0089]      FIG. 28  is a perspective view of the spinal segment shown in  FIG. 27 , wherein the embodiment of the invention is shown secured thereto. 
           [0090]      FIG. 29  is a frontal view of a spinal segment shown in cross-section. 
           [0091]      FIG. 30  is a frontal view of a spinal segment shown in cross-section, that includes an embodiment of the invention therewith. 
       
    
    
     DETAILED DESCRIPTION 
       [0092]    This invention may be characterized as an improvement of the inventor&#39;s inventions described in U.S. Pat. Nos. 5,571,189 and 5,549,679, the disclosures of which are incorporated herein by reference. 
         [0093]    With reference to the Figures,  FIGS. 1-3  illustrates an embodiment of the inventive implant  10  which consists of a sidewall band  12 , which may be characterized as being substantially tubular or ring like in shape. Preferably the band  12  is circular, however other elliptical shapes and other geometric shapes may also be used. 
         [0094]    The band  12  is pliable and malleable before its interior space  14  (not shown in  FIG. 2 ) is filled with the contents to be described. While in this initial condition, the band  12  may be passed, in a collapsed state, through a relatively small tube or portal, such as recited in U.S. Pat. Nos. 5,571,189 and 5,549,679, the entire contents of both references being incorporated herein by reference. This feature is important because access to the intervertebral disc is limited by anatomy and therefore safety considerations direct us to use the smallest possible portal of entry. 
         [0095]    The band  12  may be constructed in a variety of ways. The band material  16  may be etched, woven or braided material such as a weave of NITINOL fibers, or a form-molded material such as shown in  FIG. 6 . The material or fabric  16  may be fluid impermeable or may be provided with a density that will allow ingress and egress of fluids and solutions and will allow the ingrowth and through-growth of blood vessels and fibrous tissue and bony trabeculae. Where the material  16  is provided with such a porous construction, pores or weave gaps are preferably tight enough to retain small particles of enclosed fill material, such as ground up bone graft, other tissues or solid pieces of bone inducing material such as hydroxyapatite or other biocompatible materials known to promote bone formation. 
         [0096]    Where the material  16  of the band  12  is porous, such as in the embodiment shown in  FIGS. 1-4 , the pores or openings  18  of the fabric will have a diameter of about 0.25 mm to about 5.0 mm. The size is selected to allow tissue ingrowth while containing the material packed into the bag. 
         [0097]    The material  16  of the invention must be flexible enough to allow it to be collapsed and inserted into an opening smaller than the expanded band size. As may be seen in  FIGS. 7 and 8 , the band  12  is sufficiently flexible so that it may be positioned into a holding chamber  50  of a storage tube or delivery device  52 . Depending on the exact construction of the band  12 , the band may be compacted into a substantially smaller configuration than the band is capable of attaining when packed with graft material. The delivery device however, is sized such that the device  52  may be inserted into a surgical opening wherein the band  12  is drawn or pushed by plunger  56  out of the chamber  50 , as indicated by the direction of the arrow  54  as shown in  FIG. 8 . The band  12  may be used to repair and/or replace a vertebral disc  23  as may be seen in  FIG. 5  wherein the band is placed between adjacent vertebral bodies  24 . The band  12  may be inserted into a small opening in the annulus  21  of the disc  23  and filled from within the disc. Alternatively, the band  12  may be inserted within a hollowed region of a vertebra  24  to provide support thereto, or may be utilized to replace an entire vertebral body  24 . In order to ensure that the supportive quality of the band  12  is maintained, the fill material used in conjunction with the band  12  is preferably minimally elastic if at all. 
         [0098]    Accordingly, the fabric band  12  may be formed from a polymeric material to which a plurality of perforations are formed or added. It need not be woven and may be molded, such as the embodiment shown in  FIG. 6 , or otherwise formed as is well known in the art. The preferred material may provide the ability to tailor bioabsorbance rates. Any suture-type material used medically may be used to form the band  12 . The band  12  may be formed of plastic or even metal. The band  12  could be formed from a solid material. The band  12  may be partially or totally absorbable, metal, plastic, woven, solid, film or an extruded balloon. 
         [0099]    Preferably the material  16  is light, biocompatible, flexible and easily handled, but is also very strong in terms of resisting tension, and thus unlikely to rip or tear during insertion and expansion. When the device is expanded through insertion of fill material, such as is depicted in  FIG. 23 , the band  12  expands to a predetermined shape, and in doing so, it fills a previously excavated space  20  between the vertebral bodies and/or within a vertebral body, such as may be seen in  FIG. 5 . This filling results in the separation of the vertebral bodies  24  and results in the stabilization of the spinal motion segment, indicated generally at  22 . 
         [0100]    As may be seen in  FIGS. 1-2 , and  4 - 5 , the band  12  may be characterized as having two ends  30  and  32 . One or both ends  30  and  32  may be open as defined by the band  12 . As may be seen in  FIG. 5 , where the band  12  is utilized to replace a disc, the openings  30  and  32  are characterized as being less than the diameter of the surrounding vertebral bone, thus assuring containment of the graft material within the confines of the interior  14  of the band  12 . Where only a single end  30  or  32  is open, the material  16  which covers one or more of the openings is porous to allow for bone growth therethrough such as has been described above. 
         [0101]    In addition, as may be seen in  FIGS. 1-2  and  4 - 5 , the band  12  may be equipped with a fill opening  26 . The fill opening  26  must be large enough to accommodate passage of fill material as well as the means of placing fill material into the interior space  14  of the band  12 . A device which may be suitable for passing through the fill opening  26  for insertion of fill material is described in co-pending U.S. patent application Ser. No. 09/608,079 as discussed above. 
         [0102]    Preferably the opening  26  includes a means of preventing passage of fill material out of the interior space  14 . In the embodiment shown in  FIG. 4 , the opening  26  includes an elongate passage  28  which may be tied off or otherwise sealed subsequent to insertion of the fill material. 
         [0103]    As may be further seen in  FIG. 5  when the band  12  is inserted between two vertebra  24  or within a disc  23  or other hollowed region of an intervertebral space and filled with fill material, the fill material will push against the vertebral surfaces  40  which are adjacent to the top  30  and bottom  32  of the band  12 . The band  12  in combination with the vertebral surfaces  40  will contain the fill material within the interior space  14 . 
         [0104]    In the embodiment of the invention wherein the band material  16  is woven from one or more fibers, the fibers may be composed of a variety of materials as previously discussed. In the various embodiments shown in  FIGS. 9-18 , the band  12  may be constructed from one or more metal fibers such as, for example, NITINOL fibers  58 , which have been woven or braided together into the desired band shape. The use of a shape-memory material such as NITINOL, or a material such as steel, titanium or other metal, provides the band with sufficient mechanical strength to resist stretching or expansion as a result of the build up of graft material in the interior  14 . In addition, such shape-memory materials allow the band to be collapsed prior to insertion, such as may be seen in  FIGS. 7 and 8  yet which will tend to reacquire its original shape once implanted. 
         [0105]      FIGS. 9-18  depict a wide variety of band configurations. As may be seen in  FIGS. 9-14  the band  12  may be characterized as a double walled band or a loop of material folded back upon itself. Such a double walled configuration may be seen as having a inner wall  60  which is continuous with the outer wall  62  and defining a toroid shaped space  63  therebetween as seen in  FIGS. 10 and 12 . 
         [0106]    As seen in  FIGS. 12 and 14 , the toroidal shaped space  63  may be filled, in whole or in part with pharmaceuticals for drug delivery to the implantation site. The toroid space  63  may also be filled, subsequent to implantation into a vertebral body with a biocompatible cement or other material for providing the band  12  with additional support. 
         [0107]    The double walled construction may provide the band  12  with increased strength to provide additional mechanical support for the graft material contained in the interior  14 . In addition, the double walled construction may be configured to allow the various openings  18  of the respective walls  60  and  62  to partially overlap. As a result, the fibers  58  of one wall, for example inner wall  60 , may overlap the openings  18  of the other wall, for example outer wall  62 , thereby effectively reducing the size of the openings  18 . As a result, a band  12  having a double walled construction may not require any more fibers  58  than a single walled band such as may be seen in  FIGS. 15-18 . However, it may be desirable to provide a double walled band  12  with a denser weave of fibers  58  for the purpose of providing the band  12  with greater mechanical strength. 
         [0108]    Turning to  FIGS. 11 and 12 , a double walled band  12  may also include one or more latitudinally disposed support members such as members  64  and  66  shown. The individual support members  64  and  66  may be positioned in any manner around the circumference of the band  12 . In the embodiment shown, the members  64  and  66  are respectively disposed the first or top opening  30  and the second or bottom opening  32 . In addition the members  64  and  66  are located between the inner wall  60  and outer wall  62 . The members  64  and  66  may be used to support the material  16  of the band by weaving the fibers  58  about the members  64  and  66 , such as may best be seen in  FIG. 12 . 
         [0109]    The members  64  and  66  may be constructed from the same or different material as fibers  58 . In addition, the members  64  and  66  may be one or more wires or fibers woven or braided together and oriented in the latitudinal orientation shown. Alternatively, one or more fibers may be equatorially oriented, or may be otherwise positioned anywhere around the circumference of the band  12 . 
         [0110]    In addition to providing the band  12  with one or more latitudinally oriented wires or members  64  and  66 , the band may also include one or more longitudinally oriented members  68  such as may be seen in the embodiment shown in  FIGS. 13 and 14 . In the embodiment shown, the longitudinal members  68  vertically cross the band  12  to join the latitudinal members  64  and  66 . In addition, the longitudinal members  68  are oriented substantially perpendicular to the latitudinal members  64  and  66 . The longitudinal members  68  provide the band with compression support relative to the surrounding vertebra. The members  68  may be woven into the fibers  58  or may be independent of the band&#39;s woven configuration. In one embodiment where the band is equipped with longitudinal members  68  as well as latitudinal members  64  and  66 , the various members may act as a frame work which supports the woven fibers  58  of the band  12 . 
         [0111]    As with the latitudinal members  64  and  66 , the longitudinal members  68  may be constructed out of any suitable material. Such material may be different from or the same as the fibers  58 . Additionally, the members  68  may be characterized as one or more fibers  58  oriented in the longitudinal direction shown. 
         [0112]    In the various embodiments shown in  FIGS. 15-18  it may be seen that the band  12 , may be provided with only a single wall construction as opposed to the double walled construction previously described. As shown in  FIG. 15 , because the single wall  70  is not a continuous overlapping loop of material such as may be seen in  FIGS. 9 and 10 , the single walled band  12  shown in  FIG. 15  may have openings  30  and  32  which have fairly jagged or non-uniform edges  72 . While the material  16  of the band  12  may not necessarily be of sufficient hardness to penetrate the surrounding vertebral bone, the non-uniform nature of the edges  72  of the band  12 , provides band  12  with surfaces which may tend to more readily engage the surfaces of the surrounding vertebral bone, thereby preventing the band  12  from shifting or otherwise moving during the graft injection process or thereafter. 
         [0113]    As shown in  FIGS. 15 and 16  the single walled band  12  may be configured to have an essentially cylindrical shape. The cylindrical shape may be compressed into an elongated band such as may be seen in  FIGS. 7  an  8  prior to insertion into the body. However, the band  12  may be configured to include other shapes, notably the rounded configuration shown in  FIG. 17 , after the band  12  is inserted into a vertebral body. As may be seen in  FIG. 18 , the malleability of a single walled band is illustrated. As with all embodiments of the present invention, the band  12  may be significantly distorted, collapsed or otherwise manipulated in order to collapse the band into a reduced configuration such as may be seen in  FIGS. 7 and 8 . The present invention may be distorted in either or both the radial and longitudinal directions while retaining its ability to expand subsequent to insertion into the spinal area. 
         [0114]    As shown in  FIGS. 22 and 23 , the band  12  is shown with a fill insertion tool  100  being inserted into the interior  14  of the band  12  by passing through one of the spaces or pores  18 . The shape of the tool  100  as may best be seen in  FIGS. 19-21  is essentially an elongate shaft  104  having a tapered or pointed distal end  102 . 
         [0115]    As is shown in  FIGS. 19-21 , an example of a fill insertion tool which is suitable for use in the various embodiments of the invention is illustrated. The tool  100  is further disclosed in a co-pending U.S. patent application Ser. No. 09/738,726 filed Dec. 15, 2000 and entitled Tool to Direct Bone Replacement Material, to Kuslich et al., and is a continuation in part application of U.S. patent application Ser. No. 09/608,079 the entire contents of both being incorporated herein by reference. 
         [0116]    The tapered distal end  102  of the tool  100  is sized to enlarge the opening  18  to allow passage of the tool  100  into the interior  14  by pushing aside the various fibers  58  as may best be seen in  FIG. 22 . The fibers  58  are disposed to open the pore  18  from its nominal diameter of about 0.25 mm to about 5 mm to an enlarged opening sufficient to allow passage of a portion of the shaft  104  therethrough. 
         [0117]    The extent of tool penetration into the band interior  14  must be sufficient to allow the side opening  106  to be fully contained within the band interior  14 . The tool  100  may include more than  1  side opening  106 . 
         [0118]    As shown in  FIG. 23 , the side opening  106  allows insertion of the bone graft or other types of fill material  108  into the band interior  12 . The tool  100  may include a piston plunger or other means (not shown) for pushing fill material  108  from within the shaft  104 , through the side opening  106  and into the band interior  14 . 
         [0119]    If the internal diameter of the shaft  104  may be about 1.5 mm to 5 mm and is preferably approximately 2.5 mm in diameter. The length of the side opening  106  is preferably between about 1½ to 3 times the internal diameter of the shaft  104 . 
         [0120]    The distal end  102  of the tool  100  is preferably angled to direct the flow and to break down any material that has packed back into more discrete pieces. 
         [0121]    Turning to  FIG. 24  an embodiment of the band  12  is shown, wherein the band  12  includes at least one circumferentially disposed tightening or cinching member  65  shown. The cinching member  65  may be positioned in any manner around the circumference of the band  12  as previously described. In the embodiment shown, each member  65  extends about the mid-portion  71  of the band  12  and includes ends  73  and  75  that extend outward from one of the pores  18  where they may be pulled together and secured or tied to one another in the manner shown. When the band  12  is properly filled with fill material in any of the manners previously mentioned, the ends  73  and  75  may be cinched together in order to constrict the mid-portion of the band  12  so that the band  12  takes on a concave shape, such as is shown. The concave shape may provide greater support and flexibility to the surrounding spinal bodies and to the spine itself. When ends  73  and  75  are pulled together and secured, not only is the band provided with a concave shape, but any fill material positioned therein is pushed together for more effective engagement with surrounding tissue as well as with itself and the band  12 . 
         [0122]    In the various embodiments described herein, it may be desirable to stimulate growth of bone through the band  12  or fill material  108  contained therein, by direct or indirect application of electrical current. In the various embodiments described herein, the band  12  may include portions  81  and  83 , where electrical leads  91  and  93  may be readily attached, such as are shown in  FIG. 25 . Leads  91  and  93  are in electrical communication with an electrical power source  95  which provides sufficient current to stimulate bone growth through and adjacent to the band  12 . In at least one embodiment, the leads  91  and  93  may be inserted through pores  18 , as previously shown and described, to directly stimulate the fill material  108 . 
         [0123]    The portions  81  and  83  may be part of a electrically conductive member  85  which is disposed within the walls  60  and  62  of the band  12 , such as is shown in  FIG. 26 . Alternatively, the entire band  12  is electrically conductive, In yet another embodiment at least a portion of one or both walls  60  and  62  are electrically conductive and/or electrically insulated. 
         [0124]    In an alternative embodiment of the invention shown in  FIGS. 27 and 28 , the implant  10  may be characterized as a linear member or members  200  which is disposed about a vertebral disc  23  in a manner such as is shown in  FIG. 27 . The member  200  may be a one or more of a combination of strands, threads, fibers, cords or other substantially linear portions of material which include a first end  202  and a second end  204  that are capable of being tied or otherwise secured together. Preferably, the member  200  has a height sufficient to cover the entire exposed surface of the disc  23 . Some examples of materials which are suitable for use as member  200  or in its construction include, but are not limited to: Secure Strand available from Smith &amp; Nephew Inc., THE LOOP™, available from Spineology Inc., and Songer Cable from Medtronic Inc. 
         [0125]    In some embodiments of the invention, one of which is shown in  FIG. 28 , the member  200  may be constructed of the same material  16  as the previously described embodiments of the invention shown in  FIGS. 1-26 , and include a plurality of pores or openings  18 . Once secured about the disc  23 , the member  200  may be further cinched or otherwise tightened about the disc  23  as is shown in  FIGS. 29 and 30 . By tightening the member  200  about the disc  23 , the disc  23  is compressed in order to invaginate the annulus  21  toward its center thereby tightening the annulus fibers. Such tightening will stabilize the spinal motion segment  22  and thereby stiffen that portion of the spine. 
         [0126]    In  FIG. 29  the annulus  21  of a disk  23  is shown within a spinal motion segment  22  prior to the securement and tightening of member  200  thereabout. It is shown that the annulus  21  of the disk  23  has a predetermined height  206  and a predetermined circumference  208 . When the member  200  is disposed and subsequently tightened about the annulus  21 , such as is shown in  FIG. 30 , the circumference is reduced as indicated at reference numeral  208 ′ while the height of the disk is made greater as is indicated at reference numeral  206 ′. 
         [0127]    By securing the ends  202  and  204  of the member  200  about the disc, the member  200  forms a substantially continuous band similar to that previously described. When secured about a disc the member  200  preferably has a substantially concave appearance, relative to the surrounding spinal bodies, such as is shown in  FIG. 28 . W hen secured about the disc  23 , the disc  23  may be further treated with additional therapeutic agents, including fill material via the pores or openings  18 , in the manner previously described in relation to the embodiments shown in  FIGS. 1-26 . 
         [0128]    In addition to being directed to the specific combinations of features claimed below, the invention is also directed to embodiments having other combinations of the dependent features claimed below and other combinations of the features described above. 
         [0129]    The above disclosure is intended to be illustrative and not exhaustive. This description will suggest many variations and alternatives to one of ordinary skill in this art. All these alternatives and variations are intended to be included within the scope of the claims where the term “comprising” means “including, but not limited to”. Those familiar with the art may recognize other equivalents to the specific embodiments described herein which equivalents are also intended to be encompassed by the claims. 
         [0130]    Further, the particular features presented in the dependent claims can be combined with each other in other manners within the scope of the invention such that the invention should be recognized as also specifically directed to other embodiments having any other possible combination of the features of the dependent claims. For instance, for purposes of claim publication, any dependent claim which follows should be taken as alternatively written in a multiple dependent form from all prior claims which possess all antecedents referenced in such dependent claim if such multiple dependent format is an accepted format within the jurisdiction (e.g. each claim depending directly from claim  1  should be alternatively taken as depending from all previous claims). In jurisdictions where multiple dependent claim formats are restricted, the following dependent claims should each be also taken as alternatively written in each singly dependent claim format which creates a dependency from a prior antecedent-possessing claim other than the specific claim listed in such dependent claim below.