Patent Publication Number: US-2012029518-A1

Title: Lumbo-sacral implant system and method

Description:
TECHNICAL FIELD 
     The present disclosure generally relates to medical devices for the treatment of musculoskeletal disorders, and more particularly to an implant system and method for treating a lumbo-sacral region of a vertebral column. 
     BACKGROUND 
     Spinal disorders such as degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvature abnormalities, kyphosis, tumor, and fracture may result from factors including trauma, disease and degenerative conditions caused by injury and aging. Spinal disorders typically result in symptoms including pain, nerve damage, and partial or complete loss of mobility. 
     Non-surgical treatments, such as medication, rehabilitation and exercise can be effective, however, may fail to relieve the symptoms associated with these disorders. Surgical treatment of these spinal disorders includes fusion, fixation, discectomy, laminectomy and implantable prosthetics. Fusion and fixation treatment may employ implants such as interbody fusion devices to achieve arthrodesis. This disclosure describes an improvement over these prior art technologies. 
     SUMMARY OF THE INVENTION 
     Accordingly, an implant system and method is provided for treating the lumbo-sacral region of a vertebral column. It is contemplated that the system and method may be employed for an arthrodesis treatment. It is further contemplated that the implant system and method may be employed for an L5-S1 fusion through a direct lateral interbody trajectory. 
     In one particular embodiment, in accordance with the principles of the present disclosure, a system for treating a lumbo-sacral region is provided. The system includes at least one dilator configured to create a passageway from a direct lateral trajectory in a body defining a longitudinal axis. A cutting instrument is configured to create a bore, oriented at an angle from the longitudinal axis, in a L5 vertebrae of the body extending to a central portion of a L5-S1 intervertebral disc space of the body. A delivery instrument is configured to deliver an implant through the bore to the central portion of the L5-S1 disc space. 
     In one embodiment, a method for treating a lumbo-sacral region is provided. The method includes the steps of: making an incision in a lateral portion of a body, the body defining a longitudinal axis; creating a passageway extending from the incision to adjacent a L4-L5 intervertebral disc space of the body, the passageway being disposed at a first angle from the longitudinal axis; creating a bore in a L5 vertebrae of the body, the bore extending at a second angle from the longitudinal axis from the passageway to a central portion of a L5-S1 intervertebral disc space of the body; preparing the L5-S1 intervertebral disc space; and delivering an implant through the bore to the central portion of the L5-S1 intervertebral disc space for treatment. 
     In one embodiment, a system for treating a lumbo-sacral region employing a direct lateral interbody fusion approach is provided. The system includes a plurality of dilators configured to create a passageway through a direct lateral trajectory in a body defining a longitudinal axis. The passageway is disposed at a first angle from the longitudinal axis. A retractor defines a transverse axis and is connected with the passageway. The retractor is configured for mounting with the body such that the transverse axis is disposed at a non-parallel orientation with the longitudinal axis. A cutting instrument is configured to create a bore, extending at a second angle from the longitudinal axis, from the passageway to a central portion of a L5-S1 intervertebral disc space of the body. A delivery instrument includes a driver connected to a distal end thereof. An implant defines a socket that receives the driver and is engaged thereby such that the implant is deliverable along the second angle of the bore and rotatable relative to the bore into the central portion of an L5-S1 intervertebral disc space. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The present disclosure will become more readily apparent from the specific description accompanied by the following drawings, in which: 
         FIG. 1  is a plan view, in part cross section, of a lumbo-sacral region of a body and one particular embodiment of an implant system in accordance with the principles of the present disclosure; 
         FIG. 2  is a side view of the region and the implant system shown in  FIG. 1 ; 
         FIG. 3  is a plan view, in part cross section, of the region and the implant system shown in  FIG. 1 ; 
         FIG. 4  is an enlarged plan view of component parts of the implant system shown in  FIG. 3 ; 
         FIG. 5  is a plan view, in part cross section, of the region and one embodiment of the implant system shown in  FIG. 3 ; 
         FIG. 6  is a plan view, in part cross section, of the region and one embodiment of the implant system shown in  FIG. 3 ; 
         FIG. 7  is a side view of the region and the implant system shown in  FIG. 6 ; 
         FIG. 8  is a plan view, in part cross section, of the region and one embodiment of the implant system shown in  FIG. 3 ; and 
         FIG. 9  is a side view of the region and the implant system shown in  FIG. 8 . 
     
    
    
     Like reference numerals indicate similar parts throughout the figures. 
     DETAILED DESCRIPTION OF THE INVENTION 
     The exemplary embodiments of the implant system and related methods of use disclosed are discussed in terms of medical devices for the treatment of musculoskeletal disorders and more particularly, in terms of an implant system and method for treating a lumbo-sacral region of a vertebral column. It is envisioned that the implant system and methods of use disclosed provide a reliable and safe access to a lumbo-sacral region to perform a direct lateral interbody surgical procedure. It is further envisioned that the implant system is configured to deliver an implant to the lumbo-sacral region for an arthrodesis treatment, such as, for example, fusion and fixation. 
     It is envisioned that the present disclosure may be employed to treat spinal disorders such as, for example, degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvature abnormalities, kyphosis, tumor and fractures. It is contemplated that the present disclosure may be employed with other osteal and bone related applications, including those associated with diagnostics and therapeutics. It is further contemplated that the disclosed implant system may be alternatively employed in a surgical treatment with a patient in a prone or supine position, and/or employ various surgical approaches to the spine, including anterior, posterior, posterior mid-line, postero-lateral, and/or antero-lateral approaches, and in other body regions. The present disclosure may also be alternatively employed with procedures for treating the lumbar, cervical, thoracic and pelvic regions of a spinal column. The system and methods of the present disclosure may also be used on animals, bone models and other non-living substrates, such as, for example, in training, testing and demonstration. 
     The present invention may be understood more readily by reference to the following detailed description of the invention taken in connection with the accompanying drawing figures, which form a part of this disclosure. It is to be understood that this invention is not limited to the specific devices, methods, conditions or parameters described and/or shown herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only and is not intended to be limiting of the claimed invention. Also, as used in the specification and including the appended claims, the singular forms “a,” “an,” and “the” include the plural, and reference to a particular numerical value includes at least that particular value, unless the context clearly dictates otherwise. Ranges may be expressed herein as from “about” or “approximately” one particular value and/or to “about” or “approximately” another particular value. When such a range is expressed, another embodiment includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another embodiment. 
     The following discussion includes a description of an implant system and related methods of employing the implant system in accordance with the principles of the present disclosure. Alternate embodiments are also disclosed. Reference will now be made in detail to the exemplary embodiments of the present disclosure, which are illustrated in the accompanying figures. Turning now to  FIGS. 1-4 , there is illustrated components of an implant system  10  in accordance with the principles of the present disclosure. 
     The components of implant system  10  are fabricated from materials suitable for medical applications, including metals, polymers, ceramics, biocompatible materials, bone, autograft, allograft and/or their composites, depending on the particular application and/or preference of a medical practitioner. For example, the components of the surgical assembly, individually or collectively, can be fabricated from materials such as stainless steel, titanium, thermoplastics such as polyaryletherketone (PAEK) including polyetheretherketone (PEEK), polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEK composites, PEEK-BaSO4 polymeric rubbers, biocompatible materials such as polymers including plastics, metals, ceramics and composites thereof, rigid polymers including polyphenylene, polyimide, polyimide, polyetherimide, polyethylene, epoxy, and various components of the implant system, may have material composites, including the above materials, to achieve various desired characteristics such as strength, rigidity, elasticity, compliance, biomechanical performance, durability and radiolucency or imaging preference. 
     Implant system  10  is configured for treating a lumbo-sacral region in a surgical fusion procedure from a direct lateral interbody trajectory for stabilizing a L5-S1 junction of a body  16  of a patient. Implant system  10  includes a dilator  12  configured to create a passageway  14 . Passageway  14  is oriented from a direct lateral trajectory as shown by arrow A in  FIG. 1  in body  16 , which defines a longitudinal axis a. One or a plurality of dilators  12  may be used. 
     Passageway  14  extends from an incision (not shown) made in body  16 , to adjacent a L4-L5 intervertebral disc space I 4,5  of body  16 . Passageway  14  is disposed at a first angle α from longitudinal axis a. Dilator  12  is configured for insertion with the incision created in a lateral portion of body  16  in a direct lateral interbody surgical approach. It is contemplated that first angle α may be of various measure according to the requirements of a particular surgical application. It is further contemplated that passageway  14  may be orthogonal to longitudinal axis a. 
     Dilator  12  is employed with a retractor  18  defining a transverse axis b. Retractor  18  is connected with passageway  14  and configured for mounting with body  16  such that transverse axis b is disposed at a non-parallel orientation with longitudinal axis a. Retractor  18  is positioned to spread apart the incision leading to passageway  14  and maintain passageway  14  in an open orientation adjacent to the outer surface of body  16 . Retractor  18  is docked at angle β, as shown in  FIG. 1 , for approximate alignment with disc space I 4,5 . Angle β corresponds to the relative angular orientation of axis b with respect to an axis (shown in phantom in  FIG. 1 ) that is parallel to axis a. Angle β is oriented such that instrumentation can be inserted through a L5 vertebrae of body  16  and enter a central portion of a L5-S1 intervertebral disc space I 5,1 . It is contemplated that angle β may be of various measure according to the requirements of a particular surgical application. It is further contemplated that retractor  18  may include and/or be included with dilator  12  as one component, or may be separate components of implant system  10 . 
     In one embodiment, implant system  10  may be employed with a percutaneous approach. For example, the at least one dilator may include a cannula, mini-open retractor or tube, similar to sleeve  21  discussed below, which creates and defines a passageway for passage of the components of implant system  10 , discussed herein, to a surgical site from a direct lateral trajectory, as discussed herein. It is contemplated that this percutaneous embodiment only employs the at least one dilator, such as sleeve  21 , and does not utilize dilator  12 , passageway  14  and retractor  18 . 
     Implant system  10  includes a cutting instrument  20  configured to create a bore  22  in the L5 vertebrae. Cutting instrument  20  is delivered through passageway  14  and to a surgical site via a sleeve  21  disposed within passageway  14 . Bore  22  is oriented at an angle γ from longitudinal axis a. Bore  22  extends to a central portion  24  of disc space I 5,1 . It is contemplated that angle γ may be in a range of 0-80 degrees to facilitate creation of bore  22  through an upper edge of the L5 vertebrae and extend to central portion  24 , although other ranges are envisioned. It is further contemplated that bore  22  may be variously sized and configured, such as, for example, circular, oval, polygonal cross section, uniform diameter, non-uniform diameter, offset and/or arcuate portions, according to the requirements of a particular surgical application. 
     Implant system  10  includes a delivery instrument  26 , as shown in  FIGS. 3-4 , configured to deliver an implant  28  through bore  22  to central portion  24  of disc space I 5,1 . Delivery instrument  26  is delivered through passageway  14  and to the surgical site via sleeve  21 . Delivery instrument  26  includes a driver  30  disposed at a distal end  32 . Driver  30  is configured to engage implant  28  such that implant  28  is deliverable along angle γ of bore  22  and rotatable relative to bore  22  into central portion  24  of disc space I 5,1 . 
     Driver  30  has a ball configuration, which includes a ball tipped tamp  34 . Implant  28  defines a socket  36  configured to receive tamp  34  such that implant  28  is deliverable and rotatable. The ball tamp  34  and socket  36  configuration facilitates manipulating and rotation of implant  28  in a counter clockwise direction, as shown by arrow B in  FIG. 4 , about the turn from bore  22  into central portion  24 . Socket  36  is disposed at a side  38  of implant  28 , such as, for example, the upper left corner of implant  28  so that impaction with ball tamp  34  turns implant  28  into disc space I 5,1 . It is contemplated that implant  28  may rotate in a clockwise direction, and/or be pivoted laterally for manipulation into central portion  24  of disc space I 5,1 . It is further contemplated that distal end  32  may be flat or planar, smooth, rough, textured and/or detachably mounted with implant  28 . 
     In assembly, operation and use, implant system  10  is employed, for example, with a minimally invasive surgical procedure with a patient from a direct lateral interbody trajectory, such as, for example, a direct lateral fusion procedure for stabilizing the L5-S1 junction of body  16 . In one embodiment, implant system  10  is employed to insert implant  28  within disc space I 5,1  to space apart articular joint surfaces, provide support and maximize stabilization of the L5-S1 junction. It is contemplated that implant  28  may include a metal, plastic and/or bone spacer. It is further contemplated that implant  28  may be variously sized and dimensioned, such as, for example, round, rectangular, trapezoidal, arcuate surfaced, elliptical, smooth surfaced, textured, serrated and/or undulating. It is envisioned that implant system  10  may be used in any existing surgical method or technique including open surgery, mini-open surgery, minimally invasive surgery and percutaneous surgical implantation. Implant  28  can be delivered or implanted as a pre-assembled device or can be assembled in situ. The implant system may be completely or partially revised, removed or replaced in situ. 
     For example, during a direct lateral interbody fusion procedure, a surgeon will make an incision in the skin of lateral portion  42  ( FIG. 2 ) of a patient over and in approximate alignment with disc space I 4,5 . Dilator  12  is employed to separate the muscles and tissues to create passageway  14  through which the surgery may be performed. It is contemplated that dilator  12  may include one or a plurality of dilators to gradually separate muscle and tissue to create a portal including passageway  14 . It is further contemplated that dilator  12  may be configured as an in-situ guidance instrument and may include an endoscope camera tip. 
     Retractor  18  is positioned and docked at angle β, as discussed above, adjacent the surgical site over the incision. It is envisioned that retractor  18  may be positioned, repositioned and/or adjusted, to one or a plurality of orientations. 
     Passageway  14  is created and extends from the incision to approximately adjacent disc space I 4,5 . Passageway  14  is disposed at angle α from longitudinal axis a. Cutting instrument  20  is inserted within passageway  14  via sleeve  21  and creates bore  22  in the L5 vertebrae. It is envisioned that cutting instrument  20  may include a drill, trephine or reamer. Bore  22  extends at angle α from the initial intersection of passageway  14  and the L5 vertebrae that includes an opening  15  adjacent the upper edge of the L5 vertebrae, to a lower endplate of the L5 vertebrae at central portion  24  of disc space I 5,1 . Cutting instrument  20  is removed from passageway  14  thereafter. 
     A preparation instrument(s) (not shown) is inserted within passageway  14  and disposed within disc space I 5,1 . It is envisioned that the preparation instrument(s) may include rasps, curettes and/or a rotating tissue remover such as a rapid disc removal system that can be low profile to cut and remove disc and/or bone material simultaneously. The preparation instrument(s) is employed to remove disc tissue and fluids, adjacent tissues and/or bone, scrape and/or remove tissue from endplate surfaces of the lumbo-sacral region, as well as for aspiration and irrigation of the region according to the requirements of a particular surgical application. The preparation instrument is removed from passageway  14  thereafter. 
     Delivery instrument  26  is inserted within passageway  14  via sleeve  21  to deliver implant  28  through bore  22  to central portion  24  and into disc space I 5,1  for the arthrodesis treatment. It is envisioned that the delivery instrument  26  may include a threaded inserter or grasping instrument. Implant  28  is releasably mounted with distal end  32  of driver  30 . Driver  30  delivers implant  28  through passageway  14  into bore  22 . Implant  28  is passed through bore  22  to adjacent central portion  24  and the lower endplate of the L5 vertebrae. 
     Ball tamp  34  engages socket  36  of implant  28 , as discussed above, to manipulate and rotate central portion  24 . As shown by arrow B, in  FIG. 4 , ball tamp  34  engages socket  36  to pivot implant  28  in rotation about bore  22  and the lower endplate opening of bore  22  such that implant  28  becomes disposed in the prepared disc space I 5,1 . Delivery instrument  26  manipulates and orients implant  28  within disc space I 5,1  according to the requirements of a particular surgical application. 
     Implant  28  is manipulated to engage opposing endplates of the L5 and S1 vertebrae. The surface of implant  28  engages and spaces apart the opposing endplates and is secured within disc space I 5,1  to stabilize and immobilize portions of the lumbo-sacral junction. Fixation of implant  28  with the endplate surfaces may be facilitated by the resistance provided by the joint space and/or engagement with the endplate surfaces. It is contemplated that implant  28  may engage only one endplate. Delivery instrument  26  is removed from passageway  14  thereafter. 
     In one embodiment, implant  28  may include fastening elements, which may include locking structure, configured for fixation with the endplate surfaces to secure joint surfaces and provide complementary stabilization and immobilization to the lumbo-sacral region. It is envisioned that locking structure may include fastening elements such as, for example, clips, hooks, adhesives and/or flanges. It is envisioned that implant system  10  can be used with screws to enhance fixation, as described below. It is contemplated that implant system  10  and any screws and attachments may be coated with an osteoconductive material such as hydroxyapatite and/or osteoinductive agent such as a bone morphogenic protein for enhanced bony fixation to the treated area. Implant system  10  can be made of radiolucent materials such as polymers. Radiomarkers may be included for identification under x-ray, fluoroscopy, CT or other imaging techniques. 
     In one embodiment, implant  28  may include voids and/or openings, such as, for example, a cavity  29  ( FIGS. 3-4 ) for including therapeutic polynucleotides or polypeptides and bone growth promoting material, which can be packed or otherwise disposed therein. It is contemplated that cavity  29  includes lateral openings ( FIG. 3 ) oriented and facing disc space I 5,1 , and longitudinal openings (not shown) oriented and facing the L5 and S1 vertebrae, respectively. It is further contemplated that cavity  29  may include openings variously disposed about the surface of implant  28 . 
     For example, cavity  29  of implant  28  may include at least one agent including biocompatible materials, such as, for example, biocompatible metals and/or rigid polymers, such as, titanium elements, metal powders of titanium or titanium compositions, sterile bone materials, such as allograft or xenograft materials, synthetic bone materials such as coral and calcium compositions, such as hydroxyapatite, calcium phosphate and calcium sulfite, biologically active agents, for example, biologically active agents coated onto the exterior of implant  28  and/or applied thereto for gradual release such as by blending in a bioresorbable polymer that releases the biologically active agent or agents in an appropriate time dependent fashion as the polymer degrades within the patient. Suitable biologically active agents include, for example, bone morphogenic protein (BMP) and cytokines. 
     Implant  28  may include one or a plurality of agent reservoirs. The agent reservoirs can be configured as drug depots with medication for pain and may include antibiotics and/or therapeutics. It is envisioned that the agent reservoirs contains active agents and may include one or a plurality of therapeutic agents and/or pharmacological agents for release, including sustained release, into the lumbo-sacral region to treat, for example, pain, inflammation and degeneration. The agents may include pharmacological agents, such as, for example, antibiotics, anti-inflammatory drugs including but not limited to steroids, anti-viral and anti-retroviral compounds, therapeutic proteins or peptides, therapeutic nucleic acids (as naked plasmid or a component of an integrating or non-integrating gene therapy vector system), and combinations thereof. 
     The agent may also include analgesics or anesthetics such as acetic acid derivatives, COX-2 selective inhibitors, COX-2 inhibitors, enolic acid derivatives, propionic acid derivatives, salicylic acid derivatives, opioids, opioid/nonopioid combination products, adjuvant analgesics, and general and regional/local anesthetics. 
     The agent may also include antibiotics such as, for example, amoxicillin, beta-lactamases, aminoglycosides, beta-lactam (glycopeptide), clindamycin, chloramphenicol, cephalosporins, ciprofloxacin, erythromycin, fluoroquinolones, macrolides, metronidazole, penicillins, quinolones, rapamycin, rifampin, streptomycin, sulfonamide, tetracyclines, trimethoprim, trimethoprim-sulfamthoxazole, and vancomycin. 
     The agent may also include immunosuppressives agents, such as, for example, steroids, cyclosporine, cyclosporine analogs, cyclophosphamide, methylprednisone, prednisone, azathioprine, FK-506, 15-deoxyspergualin, prednisolone, methotrexate, thalidomide, methoxsalen, rapamycin, leflunomide, mizoribine (Bredinin™), brequinar, deoxyspergualin, and azaspirane (SKF 105685), Orthoclone OKT™ 3 (muromonab-CD3). Sandimmune™, Neoral™, Sangdya™ (cyclosporine), Prograf™ (FK506, tacrolimus), Cellcept™ (mycophenolate motefil, of which the active metabolite is mycophenolic acid), Imuran™ (azathioprine), glucocorticosteroids, adrenocortical steroids such as Deltasone™ (prednisone) and Hydeltrasol™ (prednisolone), Folex™ and Mexate™ (methotrxate), Oxsoralen-Ultra™ (methoxsalen) and Rapamuen™ (sirolimus). 
     In one embodiment, implant system  10  includes a plurality of implants  28 . It is contemplated that employing the plurality of impants  28  can optimize the amount disc space I 5,1  can be spaced apart such that the joint spacing dimension can be preselected. The plurality of implants  28  can be oriented in a side by side engagement, spaced apart and/or staggered. 
     It is envisioned that the use of microsurgical and image guided technologies may be employed to access, view and repair spinal deterioration or damage, with the aid of implant system  10 . Upon completion of the procedure, the surgical instruments and assemblies are removed and the incision is closed. It is contemplated that a surgical procedure employing implant system  10  may use other instruments, such as, for example, nerve root retractors, tissue retractors, forceps, cutter, drills, scrapers, reamers, separators, rongeurs, taps, cauterization instruments, irrigation and/or aspiration instruments, illumination instruments and/or inserter instruments. 
     Implant system  10  may be employed for performing spinal surgeries, such as, for example, discectomy, laminectomy, fusion, laminotomy, laminectomy, nerve root retraction, foramenotomy, facetectomy, decompression, spinal nucleus or disc replacement and bone graft and implantable prosthetics including plates, rods, and bone engaging fasteners. 
     In one embodiment, as shown in  FIG. 5 , implant system  10 , similar to that described above, includes an implant  128 , which is expandable between a collapsed configuration (shown in phantom) and an expanded configuration within disc space I 5,1 . Distal end  32  of driver  30  engages and manipulates implant  128  in the collapsed configuration to deliver implant  128  to disc space I 5,1 . Driver  30  rotates implant  128  about bore  22  and the lower endplate of the L5 vertebrae, as described above, so that implant  128  becomes disposed in disc space I 5,1 . As implant  128  is delivered into disc space I 5,1 , wings  130  expand with a spring biased force or force from manipulation with driver  30  to anchor implant  128  with the L5 lower endplate. Implant  128  includes a platform  132  that engages the upper endplate of the S1 vertebrae to provide distraction of disc space I 5,1 . Once expanded, implant  128  may be locked into place such that it cannot collapse. 
     Wings  130  are connected with platform  132  by a threaded bolt  134 . As bolt  134  is rotated, platform  132  applies increased force against the upper S1 endplate. Platform  132  extends, in the direction shown by arrow C in  FIG. 5 , to provide distraction of disc space I 5,1 . It is envisioned that bolt  134  may be manipulated with an articulating driver. It is contemplated that implant  128  creates a void in disc space I 5,1  to maximize bone graft insertion therein. It is further contemplated that implant  128  may include an expanding butterfly wing configuration and/or fixation elements. It is envisioned that implant  128  is employed similar to implant  28  described above. 
     In one embodiment, as shown in  FIGS. 6-7 , implant assembly  10 , similar to that described above, includes an implant  228  having a L4-L5 intervertebral implant  230  configured for disposal and treatment of a L4-L5 intervertebral disc space I 4,5  and a screw  232 . Screw  232  is configured to extend through bore  22  and disc space I 5,1 , and anchor within a sacrum S of body  16 . Screw  232 , which is anchored within sacrum S, secures implant  230  with disc space I 4,5  and the lumbo-sacral region thereby immobilizing the L5-S1 junction. Screw  232  has a lag portion  234  and a threaded portion  236  configured for penetrating sacrum S. 
     Implant  230  is delivered through passageway  14  via sleeve  21  ( FIG. 3 ) and implanted with disc space I 4,5 . Screw  232  is delivered through passageway  14  via sleeve  21  to bore  22 , similar to implant  28  described above. Distal end  32  of driver  30  ( FIGS. 3-4 ) engages screw  232  to deliver screw  232  through bore  22  and into disc space I 5,1  such that threaded portion  236  is oriented for penetrating sacrum S. Screw  232  is manipulated/rotated such that threaded portion  236  penetrates and is fixed within sacrum S. Screw  232  includes a head  238  connected with implant  230  to secure implant  230  in place upon anchoring of screw  232  with sacrum S. As such, implant  230  is anchored within disc space I 4,5 , thereby immobilizing the lumbo-sacral region and preventing back out of screw  232 . It is envisioned that implant  228  is delivered similar to implant  28  described above. 
     In one embodiment, as shown in  FIGS. 8-9 , implant assembly  10 , similar to that described above, includes an implant  328  having a screw  330  configured to extend through bore  22  and disc space I 5,1 , and anchor within a sacrum S of body  16 . Screw  330  is anchored within sacrum S and through the lumbo-sacral region to immobilize the L5-S1 junction. Screw  330  has a lag portion  332  and a threaded portion  334  configured for penetrating sacrum S. 
     Screw  330  is delivered through passageway  14  via sleeve  21  ( FIG. 3 ) to bore  22 , similar to implant  28  described above. Distal end  32  of driver  30  ( FIGS. 3-4 ) engages screw  330  to deliver screw  330  through bore  22  and into disc space I 5,1  such that threaded portion  334  is oriented for penetrating sacrum S. Screw  330  is manipulated/rotated such that threaded portion  334  penetrates and is fixed within sacrum S. Screw  330  includes a head  336  that is fastened with an upper endplate and/or other regions of the L5 vertebrae to secure screw  330  in place. As such, screw  330  is anchored with the L5 vertebrae adjacent the disc space I 4,5  and sacrum S to immobilize the lumbo-sacral region and prevent back out of screw  330 . It is envisioned that implant  328  is delivered similar to implant  28  described above. 
     It will be understood that various modifications may be made to the embodiments disclosed herein. Therefore, the above description should not be construed as limiting, but merely as exemplification of the various embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.