Patent Document

CROSS-REFERENCE TO A RELATED APPLICATION 
   This application is a continuation of U.S. Ser. No. 09/947,078, filed Sep. 5, 2001 now U.S. Pat. No. 6,592,625; which is a continuation of U.S. Ser. No. 09/484,706, filed Jan. 18,2000 (now abandoned); which claims the benefit of U.S. Provisional Application No. 60/160,710, filed Oct. 20, 1999. 

   FIELD OF THE INVENTION 
   The invention generally relates to a surgical method of intervertebral disc wall reconstruction. The invention also relates to an annular repair device, or stent, for annular disc repair. The effects of said reconstruction are restoration of disc wall integrity and reduction of the failure rate (3–21%) of a common surgical procedure (disc fragment removal or discectomy). This surgical procedure is performed about 390,000 times annually in the United States. 
   BACKGROUND OF THE INVENTION 
   The spinal column is formed from a number of vertebrae, which in their normal state are separated from each other by cartilaginous intervertebral discs. The intervertebral disc acts in the spine as a crucial stabilizer, and as a mechanism for force distribution between the vertebral bodies. Without the disc, collapse of the intervertebral space occurs in conjunction with abnormal joint mechanics and premature development of arthritic changes. 
   The normal intervertebral disc has an outer ligamentous ring called the annulus surrounding the nucleus pulposus. The annulus binds the adjacent vertebrae together and is constituted of collagen fibers that are attached to the vertebrae and cross each other so that half of the individual fibers will tighten as the vertebrae are rotated in either direction, thus resisting twisting or torsional motion. The nucleus pulposus is constituted of loose tissue, having about 85% water content, which moves about during bending from front to back and from side to side. 
   The aging process contributes to gradual changes in the intervertebral discs. The annulus loses much of its flexibility and resilience, becoming more dense and solid in composition. The aging annulus is also marked by the appearance on propagation of cracks or fissures in the annular wall. Similarly, the nucleus dessicates, increasing viscosity and thus losing its fluidity. In combination, these features of the aged intervertebral discs result in less dynamic stress distribution because of the more viscous nucleus pulposus, and less ability to withstand localized stresses by the annulus fibrosus due to its dessication, loss of flexibility and the presence of fissures. Occasionally fissures may form rents through the annular wall. In these instances, the nucleus pulposus is urged outwardly from the subannular space through a rent, often into the spinal column. Extruded nucleus pulposus can, and often does, mechanically press on the spinal cord or spinal nerve rootlet. This painful condition is clinically referred to as a ruptured or herniated disc. 
   In the event of annulus rupture, the subannular nucleus pulposus migrates along the path of least resistance forcing the fissure to open further, allowing migration of the nucleus pulposus through the wall of the disc, with resultant nerve compression and leakage of chemicals of inflammation into the space around the adjacent nerve roots supplying the extremities, bladder, bowel and genitalia. The usual effect of nerve compression and inflammation is intolerable back or neck pain, radiating into the extremities, with accompanying numbness, weakness, and in late stages, paralysis and muscle atrophy, and/or bladder and bowel incontinence. Additionally, injury, disease or other degenerative disorders may cause one or more of the intervertebral discs to shrink, collapse, deteriorate or become displaced, herniated, or otherwise damaged and compromised. 
   The surgical standard of care for treatment of herniated, displaced or ruptured intervertebral discs is fragment removal and nerve decompression without a requirement to reconstruct the annular wall. While results are currently acceptable, they are not optimal. Various authors report 3.1–21% recurrent disc herniation, representing a failure of the primary procedure and requiring re-operation for the same condition. An estimated 10% recurrence rate results in 39,000 re-operations in the United States each year. 
   An additional method of relieving the symptoms is thermal annuloplasty, involving the heating of sub-annular zones in the non-herniated painful disc, seeking pain relief, but making no claim of reconstruction of the ruptured, discontinuous annulus wall. 
   There is currently no known method of annulus reconstruction, either primarily or augmented with an annulus stent. 
   BRIEF SUMMARY OF THE INVENTION 
   The present invention provides methods and related materials for reconstruction of the disk wall in cases of displaced, herniated, ruptured, or otherwise damaged intervertebral discs. In accordance with the invention, an annulus stent is disclosed for repair of an intervertebral disc annulus, comprising a centralized hub section, said hub section comprising lateral extensions from the hub section. 
   In an exemplary embodiment, one or more mild biodegradable surgical sutures are placed at about equal distances along the sides of a pathologic aperture in the ruptured disc wall (annulus) or along the sides of a surgical incision in the annular wall, which may be weakened or thinned. 
   In another embodiment as depicted in  FIG. 7B , the method can be augmented by creating a subannular barrier in and across the aperture by placement of a patch of human muscle fascia (the membrane covering the muscle) or any other autograft, autograft, or xenograft acting as a bridge or a scaffold, providing a platform for traverse of fibroblasts or other normal cells of repair existing in and around the various layers of the disc annulus, prior to closure of the aperture. 
   A 30–50% reduction in the rate of recurrence of disc herniation has been achieved using the aforementioned fascial augmentation with this embodiment. 
   Having demonstrated that human muscle fascia is adaptable for annular reconstruction, other biocompatible membranes can be employed as a bridge, stent, patch or barrier to subsequent migration of the disc nucleus through the aperture. Such biocompatible materials may be, for example, medical grade biocompatible fabrics, biodegradable polymeric sheets, or form fitting or non-form fitting fillers for the cavity created by removal of a portion of the disc nucleus pulposus in the course of the disc fragment removal or discectomy. The prosthetic material can be placed in and around the intervertebral space, created by removal of the degenerated disc fragments. 
   Additional objects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. The objects and advantages of the invention will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims. 
   It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
     The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate illustrative embodiments of the invention and, together with the description, serve to explain the principles of the invention. 
       FIG. 1  shows a perspective view of an illustrative embodiment of an annulus stent. 
       FIG. 2  shows a front view of the annulus stent of  FIG. 1 . 
       FIG. 3  shows a side view of the annulus stent of  FIG. 1 . 
       FIGS. 4A–4C  show a front view of alternative illustrative embodiments of an annulus stent. 
       FIGS. 5A–5B  show the alternative embodiment of a further illustrative embodiment of an annulus stent. 
       FIGS. 6A–6B  show the alternative embodiment of a further illustrative embodiment of an annulus stent. 
       FIG. 7A–7B  shows a primary closure of an opening in the disc annulus. 
       FIGS. 8A–8B  show a primary closure with a stent. 
       FIG. 9  shows a method of suturing an annulus stent into the disc annulus, utilizing sub-annular fixation points. 
       FIGS. 10A–10B  show a further illustrative embodiment of an annulus stent with flexible bladder being expanded into the disc annulus. 
       FIGS. 11A–11D  show an annulus stent being inserted into the disc annulus. 
       FIGS. 12A–12B  show an annulus stent with a flexible bladder being expanded. 
   

   DETAILED DESCRIPTION OF THE INVENTION 
   Reference will now be made in detail to an illustrative embodiment of the invention, which appears in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts. 
   In one embodiment of the present invention, as shown in  FIG. 7A , a damaged annulus  42  is repaired by use of surgical sutures  40 . One or more surgical sutures  40  are placed at about equal distances along the sides of a pathologic aperture  44  in the annulus  42 . Reapproximation or closure of the aperture  44  is accomplished by tying the sutures  40  so that the sides of the aperture  44  are drawn together. The reapproximation or closure of the aperture  44  enhances the natural healing and subsequent reconstruction by the natural tissue (e.g., fibroblasts) crossing the now surgically narrowed gap in the annulus  42 . Preferably, the surgical sutures  40  are biodegradable, but permanent non-biodegradable may be utilized. 
   Additionally, to repair a weakened or thinned wall of a disc annulus  42 , a surgical incision is made along the weakened or thinned region of the annulus  42  and one or more surgical sutures  40  can be placed at about equal distances laterally from the incision. Reapproximation or closure of the incision is accomplished by tying the sutures  40  so that the sides of the incision are drawn together. The reapproximation or closure of the incision enhances the natural healing and subsequent reconstruction by the natural tissue crossing the now surgically narrowed gap in the annulus  42 . Preferably, the surgical sutures  40  are biodegradable, but permanent non-biodegradable materials may be utilized. 
   In an alternative embodiment as depicted in  FIG. 7B , the method can be augmented by the placement of a patch of human muscle fascia or any other autograft, autograft or xenograft in and across the aperture  44 . The patch acts as a bridge in and across the aperture  44 , providing a platform for traverse of fibroblasts or other normal cells of repair existing in and around the various layers of the disc annulus  42 , prior to closure of the aperture  44 . 
   In a further embodiment, as shown in  FIGS. 8A–B  a biocompatible membrane can be employed as an annulus stent  10 , being placed in and across the aperture  44 . The annulus stent  10  acts as a bridge in and across the aperture  44 , providing a platform for a traverse of fibroblasts or other normal cells of repair existing in and around the various layers of the disc annulus  42 , prior to closure of the aperture  44 . 
   In an illustrative embodiment, as shown in  FIGS. 1–3 , the annulus stent  10  comprises a centralized vertical extension  12 , with an upper section  14  and a lower section  16 . The centralized vertical extension  12  can be trapezoid in shape through the width and may be from about 8 mm–12 mm in length. 
   Additionally, the upper section  14  of the centralized vertical extension  12  may be any number of different shapes, as shown in  FIGS. 4A and 4B , with the sides of the upper section  14  being curved or with the upper section  14  being circular in shape. Furthermore, the annulus stent  10  may contain a recess between the upper section  14  and the lower section  16 , enabling the annulus stent  10  to form a compatible fit with the edges of the aperture  44 . 
   The upper section  14  of the centralized vertical extension  12  can comprise a slot  18 , where the slot  18  forms an orifice through the upper section  14 . The slot  18  is positioned within the upper section  14  such that it traverses the upper section&#39;s  14  longitudinal axis. The slot  18  is of such a size and shape that sutures, tension bands, staples or any other type of fixation device known in the art may be passed through, to affix the annulus stent  10  to the disc annulus  42 . 
   In an alternative embodiment, the upper section  14  of the centralized vertical extension  12  may be perforated. The perforated upper section  14  contains a plurality of holes that traverse the longitudinal axis of upper section  14 . The perforations are of such a size and shape that sutures, tension bands, staples or any other type of fixation device known the art may be passed through, to affix the annulus stent  10  to the disc annulus  42 . 
   The lower section  16  of the centralized vertical extension  12  can comprise a pair of lateral extensions, a left lateral extension  20  and a right lateral extension  22 . The lateral extensions  20  and  22  comprise an inside edge  24 , an outside edge  26 , an upper surface  28 , and a lower surface  30 . The lateral extensions  20  and  22  can have an essentially constant thickness throughout. The inside edge  24  is attached to and is about the same length as the lower section  16 . The outside edge  26  can be about 8 mm–16 mm in length. The inside edge  24  and the lower section  16  meet to form a horizontal plane, essentially perpendicular to the centralized vertical extension  12 . The upper surface  28  of the lateral extensions  20  and  22  can form an angle from about 0°–60° below the horizontal plane. The width of the annulus stent  10  may be from about 3 mm–5 mm. 
   Additionally, the upper surface  28  of the lateral extensions  20  and  22  may be barbed for fixation to the inside surface of the disc annulus  42  and to resist expulsion through the aperture  44 . 
   In an alternative embodiment, as shown in  FIG. 4B , the lateral extensions  20  and  22  have a greater thickness at the inside edge  24  than at the outside edge  26 . 
   In an illustrative embodiment, the annulus stent  10  is a solid unit, formed from one or more of the flexible resilient biocompatible or bioresorbable materials well know in the art. 
   For example, the annulus stent  10  may be made from:
         a porous matrix or mesh of biocompatible and bioresorbable fibers acting as a scaffold to regenerate disc tissue and replace annulus fibrosus as disclosed in, for example, U.S. Pat. No. 5,108,438 (Stone) and U.S. Pat. No. 5,258,043 (Stone), a strong network of inert fibers intermingled with a bioresorbable (or bioabsorable) material which attracts tissue ingrowth as disclosed in, for example, U.S. Pat. No. 4,904,260 (Ray et al.);   a biodegradable substrate as disclosed in, for example, U.S. Pat. No. 5,964,807 (Gan at al.); or   an expandable polytetrafluoroethylene (ePTFE), as used for conventional vascular grafts, such as those sold by W.L. Gore and Associates, Inc. under the trademarks GORE-TEX and PRECLUDE, or by Impra, Inc. under the trademark IMPRA.       

   Furthermore, the annulus stent  10 , may contain hygroscopic material for a controlled limited expansion of the annulus stent  10  to fill the evacuated disc space cavity. 
   Additionally, the annulus stent  10  may comprise materials to facilitate regeneration of disc tissue, such as bioactive silica-based materials that assist in regeneration of disc tissue as disclosed in U.S. Pat. No. 5,849,331 (Ducheyne, et al.), or other tissue growth factors well known in the art. 
   In further embodiments, as shown in FIGS.  5 AB– 6 AB, the left and right lateral extensions  20  and  22  join to form a solid pyramid or cone. Additionally, the left and right lateral extensions  20  and  22  may form a solid trapezoid, wedge, or bullet shape. The solid formation may be a solid biocompatible or bioresorbable flexible material, allowing the lateral extensions  20  and  22  to be compressed for insertion into aperture  44 , then to expand conforming to the shape of the annulus &#39;  42  inner wall. 
   Alternatively, a compressible core may be attached to the lower surface  30  of the lateral extensions  20  and  22 , forming a pyramid, cone, trapezoid, wedge, or bullet shape. The compressible core may be made from one of the biocompatible or bioresorbable resilient foams well known in the art. The core can also comprise a fluid-expandable membrane, e.g., a balloon. The compressible core allows the lateral extensions  20  and  22  to be compressed for insertion into aperture  44 , then to expand conforming to the shape of the annulus &#39;  42  inner wall and to the cavity created by pathologic extrusion or surgical removal of the disc fragment. 
   In an illustrative method of use, as shown in  FIGS. 11A–D , the lateral extensions  20  and  22  are compressed together for insertion into the aperture  44  of the disc annulus  42 . The annulus stent  10  is then inserted into the aperture  44 , where the lateral extensions  20 ,  22  expand. In an expanded configuration, the upper surface  28  can substantially conform to the contour of the inside surface of the disc annulus  42 . The upper section  14  is positioned within the aperture  44  so that the annulus stent  10  may be secured to the disc annulus  42 , using means well known in the art. 
   In an alternative method, where the length of the aperture  44  is less than the length of the outside edge  26  of the annulus stent  10 , the annulus stent  10  can be inserted laterally into the aperture  44 . The lateral extensions  20  and  22  are compressed, and the annulus stent  10  can then be laterally inserted into the aperture  44 . The annulus stent  10  can then be rotated inside the disc annulus  42 , such that the upper section  14  can be held back through the aperture  44 . The lateral extensions  20  and  22  are then allowed to expand, with the upper surface  28  contouring to the inside surface of the disc annulus  42 . The upper section  14  can be positioned within, or proximate to, the aperture  44  in the subannular space such that the annulus stent  10  may be secured to the disc annulus, using means well known in the art. 
   In an alternative method of securing the annulus stent  10  in the aperture  44 , as shown in  FIG. 9 , a first surgical screw  50  and second surgical screw  52 , with eyeholes  53  located at the top of the screws  50  and  52 , are opposingly inserted into the adjacent vertebrae  54  and  56  below the annulus stent  10 . After insertion of the annulus stent  10  into the aperture  44 , a suture  40  is passed down though the disc annulus  42 , adjacent to the aperture  44 , through the eye hole  53  on the first screw  50  then back up through the disc annulus  42  and through the orifice  18  on the annulus stent  10 . This is repeated for the second screw  52 , after which the suture  40  is secured. One or more surgical sutures  40  are placed at about equal distances along the sides of the aperture  44  in the disc annulus  42 . Reapproximation or closure of the aperture  44  is accomplished by tying the sutures  40  in such a fashion that the sides of the aperture  44  are drawn together. The reapproximation or closure of the aperture  44  enhances the natural healing and subsequent reconstruction by the natural tissue crossing the now surgically narrowed gap in the annulus  42 . Preferably, the surgical sutures  40  are biodegradable but permanent non-biodegradable forms may be utilized. This method should decrease the strain on the disc annulus  42  adjacent to the aperture  44 , precluding the tearing of the sutures through the disc annulus  42 . 
   It is anticipated that fibroblasts will engage the fibers of the polymer or fabric of the intervertebral disc stent  10 , forming a strong wall duplicating the currently existing condition of healing seen in the normal reparative process. 
   In an additional embodiment, as shown in  FIGS. 10A–B , a flexible bladder  60  is attached to the lower surface  30  of the annulus stent  10 . The flexible bladder  60  comprises an internal cavity  62  surrounded by a membrane  64 , where the membrane  64  is made from a thin flexible biocompatible material. The flexible bladder  60  is attached to the lower surface  30  of the annulus stent  10  in an unexpanded condition. The flexible bladder  60  is expanded by injecting a biocompatible fluid or expansive foam, as known in the art, into the internal cavity  62 . The exact size of the flexible bladder  60  can be varied for different individuals. The typical size of an adult nucleus is about 2 cm in the semi-minor axis, 4 cm in the semi-major axis, and 1.2 cm in thickness. 
   In an alternative embodiment, the membrane  64  is made of a semi-permeable biocompatible material. 
   In an illustrative embodiment, a hydrogel is injected into the internal cavity  62  of the flexible bladder  60 . A hydrogel is a substance formed when an organic polymer (natural or synthetic) is cross-linked via, covalent, ionic, or hydrogen bonds to create a three-dimensional open-lattice structure, which entraps water molecules to form a gel. The hydrogel may be used in either the hydrated or dehydrated form. 
   In a method of use, where the annulus stent  10  has been inserted into the aperture  44 , as has been previously described and shown in  FIGS. 12A–B , an injection instrument, as known in the art, such as a syringe, is used to inject the biocompatible fluid or expansive foam into the internal cavity  62  of the flexible bladder  60 . The biocompatible fluid or expansive foam is injected through the annulus stent  10  into the internal cavity  62  of the flexible bladder  60 . Sufficient material is injected into the internal cavity  62  to expand the flexible bladder  60  to fill the void in the intervertebral disc cavity. The use of the flexible bladder  60  is particularly useful when it is required to remove all or part of the intervertebral disc nucleus. 
   The surgical repair of an intervertebral disc may require the removal of the entire disc nucleus, being replaced with an implant, or the removal of a portion of the disc nucleus thereby leaving a void in the intervertebral disc cavity. The flexible bladder  60  allows for the removal of only the damaged section of the disc nucleus, with the expanded flexible bladder  60  filling the resultant void in the intervertebral disc cavity. A major advantage of the annulus stent  10  with the flexible bladder  60  is that the incision area in the annulus  42  can be reduced in size, as there is no need for the insertion of an implant into the intervertebral disc cavity. 
   In an alternative method of use, a dehydrated hydrogel is injected into the internal cavity  62  of the flexible bladder  60 . Fluid, from the disc nucleus, passes through the semipermeable membrane  64  hydrating the dehydrated hydrogel. As the hydrogel absorbs the fluid the flexible bladder  60  expands, filling the void in the intervertebral disc cavity. 
   All patents referred to or cited herein are incorporated by reference in their entirety to the extent they are not inconsistent with the explicit teachings of this specification, including; U.S. Pat. No. 5,108,438 (Stone), U.S. Pat. No. 5,258,043 (Stone), U.S. Pat. No. 4,904,260 (Ray et al.), U.S. Pat. No. 5,964,807 (Gan et al.), U.S. Pat. No. 5,849,331 (Ducheyne et al.), U.S. Pat. No. 5,122,154 (Rhodes), U.S. Pat. No. 5,204,106 (Schepers at al.), U.S. Pat. No. 5,888,220 (Felt et al.) and U.S. Pat. No. 5,376,120 (Sarver et al.). 
   It should be understood that the examples and embodiments described herein are for illustrative purposes only and that various modifications or changes in light thereof will be suggested to persons skilled in the art and are to be included within the spirit and preview of this application and the scope of the appended claims.

Technology Category: 4