Abstract:
Cage systems that improve upon the prior art in various ways. In the preferred embodiments, devices are radiolucent, with markers, thereby allowing visualization of placement without excessive obscuration. Devices according to the invention eliminate multiple steps, instruments and trays, while being capable of a custom fit. The devices according to the invention permit easier and greater access to end plate surface area, and can be used with autografts, allografts, and biologics.

Description:
REFERENCE TO RELATED APPLICATION 
       [0001]    This application is a continuation of U.S. patent application Ser. No. 10/691,854, filed Oct. 23, 2003, which claims priority from U.S. Provisional Patent Application Ser. No. 60/420,616, filed Oct. 23, 2002, the entire content of both of which are incorporated herein by reference. 
     
    
     FIELD OF THE INVENTION 
       [0002]    This invention relates generally to spinal implants and, in particular, to improved intervertebral cage designs. 
       BACKGROUND OF THE INVENTION 
       [0003]    There are many intervertebral implants to assist with stabilization and fixation, including pre-assembled mesh rings of varying size; cylindrical threaded cages; carbon fiber boxes; and bone dowels, rings, and wedges. However, all existing devices have certain drawbacks, including the requirement of multiple steps and tools to prepare and mold the intervertebral plates for acceptance of the devices. 
         [0004]    Existing implants also exhibit the need to remove/move a distraction device such as a spreader or plugs around a decorticate. Such plugs/distraction devices often get in the way of cage placement. Mesh cages in bone materials can deform or break with attempts to force them into the inner space. Typically, only a small surface of the end plate is exposed to bone graft, this being dictated by the size and position of the cage. Existing devices also require large trays with many instruments and many cages, and it is difficult to see the bone fused in mass inside metal cages, which are radiopaque. 
       SUMMARY OF THE INVENTION 
       [0005]    This invention resides in cage systems that improve upon the prior art in various ways. In the preferred embodiments, devices are radiolucent, with markers, thereby allowing visualization of placement without excessive obscuration. Devices according to the invention eliminate multiple steps, instruments and trays, while being capable of a custom fit. The devices according to the invention permit easier and greater access to end plate surface area, and can be used with autografts, allografts, and biologics. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0006]      FIG. 1  is a drawing that shows a preferred embodiment of the invention; 
           [0007]      FIG. 2A  is a drawing which shows a contoured, wedge-shaped retractor; 
           [0008]      FIG. 2B  shows a side view of a U-shaped introducer; 
           [0009]      FIG. 2C  shows a top view of the U-shaped introducer; 
           [0010]      FIG. 2D  shows the U-shaped introducer received within a cage; 
           [0011]      FIG. 2E  is a side view of a graft impactor; 
           [0012]      FIG. 2F  is a side view of the graft impactor but with an end view of the impactor tip; 
           [0013]      FIG. 2G  shows a gate holder with a screw mechanism used to capture and release a gate; 
           [0014]      FIG. 2H  is a drawing of a screwdriver; 
           [0015]      FIG. 3A  shows cage shapes for levels L 2 -L 5 ; 
           [0016]      FIG. 3B  shows cage shapes for levels L 5 /S 1 ; 
           [0017]      FIG. 3C  shows cage shapes for levels T/L 2 ; 
           [0018]      FIG. 4A  shows how disc material is removed to determine the lateral extent of a disc space; 
           [0019]      FIG. 4B  is a drawing that shows a disc space being dilated to a desired height using distracters which are preferably color coded; 
           [0020]      FIG. 4C  shows a cage being inserted; 
           [0021]      FIG. 4D  illustrates how, with the implant released and the introducer tool removed, easy access is available to the end plates; 
           [0022]      FIG. 4E  shows how end plates are prepared, and grafting material, biologics, and so forth are packed in; 
           [0023]      FIG. 5A  is a first view of an implant according to the invention; 
           [0024]      FIG. 5B  is a second view of an implant according to the invention; 
           [0025]      FIG. 6A  is a drawing that shows how a proximal guide sleeve is attached onto one vertical side wall of the cage and drilled and tapped as necessary; 
           [0026]      FIG. 6B  shows a locking screw in position; 
           [0027]      FIG. 6C  shows how a universal screw driver/holder is used to place distal screws into the cage; 
           [0028]      FIG. 6D  depicts the lower aspect of a cage being locked into a distal vertebrae; 
           [0029]      FIG. 6E  is a lateral view of a cage in place; 
           [0030]      FIG. 6F  is an anterior-posterior (AP) view of a cage in place; 
           [0031]      FIG. 7A  begins a series of drawings that depict an alternative embodiment of the invention including a different form of anterior fixation; 
           [0032]      FIG. 7B  shows how a fixation jig is used to introduce a screw or similar device through the intervertebral body proximally into the superior cage walls 
           [0033]      FIG. 7C  shows how inferior fixation is accomplished with a ratchet screwdriver/holder to deliver a fastener through the inferior wall of the cage into the vertebral body 
           [0034]      FIG. 7D  is a drawing that shows how the screw preferably angles out laterally; 
           [0035]      FIG. 7E  depicts a fixed cage in place; 
           [0036]      FIG. 8A  shows the anchoring screw being pushed; 
           [0037]      FIG. 8B  shows the pins advanced; 
           [0038]      FIG. 8C  shows the device in-situ; 
           [0039]      FIG. 9A  shows the hinged contoured back wall with the inserter prior to use; 
           [0040]      FIG. 9B  shows the back wall being straightened and the side walls being spaced apart; 
           [0041]      FIG. 10A  illustrates a different embodiment involving a sliding lateral expandable cage with locking screws; and 
           [0042]      FIG. 10B  shows an expanded condition with the locking screws being used to stabilize the structure at a desired level of expansion. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0043]    A first preferred embodiment of the invention is depicted in  FIG. 1 . This design includes an open-faced cage  102 , which is constructed of carbon fiber or other radiolucent material but for small dot radiopaque markers (not shown). The device includes a contoured dome-shaped side walls  104 ,  104 ′ with a flat trapezoidal undersurface. Separate cages and tools may be used for the L 5 -S 1  levels with more pronounced trapezoidal shapes. An indented back wall  110  is used to prevent neurocompression. The side walls preferably include a recessed face with nippled intents  112  and screw holes  114  to receive a locking screw  116 . A closing face gate  120  is provided with non-slip nipples and locking screw holes as well. 
         [0044]    In addition to the dome-shaped contours of the upper end plate, different shapes for the L 5 -S 1  levels, and the indented back wall, the use of an open-face plate with gate and locking screw mechanism allows the device to be packed and closed in-situ, thereby effectively assembling the cage between the vertebrae. Note that although this design includes numerous features which are believed to be novel, they need not be used entirely in combination, but may be used separately or combined in subsets. The side view at the right in  FIG. 1  illustrates the optional use of sawtooth features  125  on the upper surface  130 , which is preferably dome-shaped, and the lower surface  140 , which is preferably flat. 
         [0045]      FIG. 2  is a series of drawings which shows the instruments used to implant devices according to the invention. Most or all are removably attached able to a ratchet handle  200 . The set includes a screwdriver  202  ( FIG. 2H ); contoured, wedge-shaped retractors  206 , preferably including a color-coded raised centering mark or ridge  207  ( FIG. 2A ); U-shaped introducers  208  ( FIG. 2B ), preferably including retractable wings  209  ( FIG. 2C ) to release a cage  210  ( FIG. 2D ) using control  211 ; graft impactors  220  ( FIGS. 2E ,  2 F) and gate holder  230  including a screw mechanism  232  used to capture and release a gate  240  ( FIG. 2G ). The impactors  230  are generally 25 in length, and preferably come in different sizes, such as 0.8 cm at one end and 1-2 cm at the other, 0.5 cm at one end and 1 cm or less at the other, and so forth. 
         [0046]      FIG. 3  shows how cage shapes would preferably be varied for different vertebral levels.  FIG. 3A  shows cage shapes for L 2 -L 5 ;  FIG. 3B  shows cage shapes for L 5 /S 1 ; and  FIG. 3C  shows cage shapes for T/L 2 . In each case, the implants would preferably utilize some or all of the other geometries described herein, including a general U-shaped construction, crescent-shaped side walls, domed tops, indented back wall, carbon fiber or other radiolucent construction with markers, serrated or tooth-edged, end-plate surfaces, and so forth. The devices would also preferably include correspondingly sized anterior gates, also utilizing carbon fiber or other radiolucent material, with non-slip nipples, locking screw holes and associated screws. 
         [0047]      FIG. 4  is a series of drawings which show a method involving an anterior approach to the intervertebral space. In  FIG. 4A , disc material is removed with tool  402  to determine the lateral extent of the space. In  FIG. 4B , the disc space is dilated to a desired height using distracters  206  which are preferably color coded. The final distracter is removed and replaced with the same color-coded implant introducer instrument  208 , with the cage being inserted as shown in  FIG. 4C . The implant is released and the introducer tool removed, allowing easy access  410  to the end plates as shown in  FIG. 4D . 
         [0048]    In  FIG. 4E , the end plates are prepared, and grafting material, biologics, and so forth are packed in. In  FIG. 4F , a correspondingly sized anterior gate is locked into position using the gate holder and locking screws and screwdriver, and the wound is closed.  FIG. 5  begins a series of drawings which shows an alternative embodiment of the invention which allows for an in-situ cage to act as a stand-alone radiolucent cage system. In addition to the instruments previously described, this embodiment utilizes proximal left/right guide sleeves, a drill and universal head screwdriver. In terms of the implant itself, proximal and distal screws are used in conjunction with an in-situ cage having a locking gate, in this case modified to accept proximal screws and guide inferior screws. Different views of the implant are shown in  FIGS. 5A and 5B . 
         [0049]    In terms of the operative procedure, the steps previously described involving cage insertion are followed. However, in this case, a proximal guide sleeve is attached onto one vertical side wall of the cage and drilled and tapped as necessary, as shown in  FIG. 6A . The locking screw is shown in place in  FIG. 6B . The universal screw driver/holder is used to place distal screws into the cage, as shown in  FIG. 6C , allowing the lower aspect of the cage to be locked into the distal vertebrae as shown in  FIG. 6D .  FIG. 6E  is a lateral view of the cage in place, and  FIG. 6F  is an A-P view. 
         [0050]    Now turning to  FIGS. 7  and higher, which depict yet a further alternative embodiment including a different form of anterior fixation. As shown in this case, a fixation jig  700  is used to introduce a screw or similar device through the intervertebral body proximally into the superior cage walls, as shown in  FIG. 7B . Inferior fixation is accomplished with a ratchet screwdriver/holder  702  , which delivers the fastener through the inferior wall of the cage into the vertebral body as shown in  FIG. 7C . The screw preferably angles out laterally, as shown in  FIG. 7D , with the fixed cage in place in  FIG. 7E .  FIG. 8  is a series of drawings which shows internal fixation using an advancing screw to push a fixation pin into the cortical end plate.  FIG. 8A  shows the anchoring screw  802  being pushed,  FIG. 8B  shows the pins  804  advanced, and  FIG. 8C  shows the device in-situ. 
         [0051]      FIG. 9  shows yet a different alternative embodiment of the invention in the form of a collapsing cage suitable for endoscopic placement. The cage is hinged enabling it to be laterally expandable with an expandable cage inserter.  FIG. 9A  shows the hinged contoured back wall  902  with the inserter prior to use, and  FIG. 9B  shows the back wall being straightened and the side walls being spaced apart.  FIG. 10  shows a different embodiment involving a sliding lateral expandable cage  10  with locking screws  12 . Again, an expandable cage inserter is used to move the side walls apart from the condition in  FIG. 10A  to the expanded condition in  FIG. 10B  with the locking screw being used to stabilize the structure at a desired level of expansion.