Abstract:
A fixation device for use in association with ALIF procedures includes a couple of spaced plates having integral spikes on facing surfaces thereof for pressing into spinal processes of adjacent vertebrae. One of the plates has a spherical socket which captures a spherical head end of a post whose other end is received through an aperture in the other plate. The socket mounting is arranged to enable the post to pivot therein for at least two degrees of freedom to a limited extent, enabling angulation between the two plates so as to accommodate the different thicknesses and orientations of the spinal processes on adjacent vertebrae. The reception of the post in the second plate enables adjustment of spacing between the plates to accommodate effective installation of the assembly on the spinal processes by a compression instrument, and permanent reliable maintenance of that spacing following removal of the compression instrument. The cross-sectional configuration of the post and a receiver aperture in the plate inhibits rotation of the plate relative to the post about the post axis, and a set screw in the apertured plate engages a flat on the post fixing the inter-plate space as adjusted.

Description:
BACKGROUND OF THE INVENTION  
         [0001]    1. Field of the Invention  
           [0002]    This invention relates generally to spinal surgery, and more particularly to devices for stabilization of the spine in association with placement of an inter-body construct for interbody fusion or the like.  
           [0003]    2. Description of the Prior Art  
           [0004]    Varieties of inter-body fusion devices are widely used following partial or total discectomies, for stabilization of the spine at the site. Some stabilization devices are anchored to the pedicles. With several systems, the use of the pedicles requires screws or other anchorage devices that occupy significant space and involve muscle dissection and associated work time for implantation. We believe that such elaborate apparatus and procedures are unnecessary in many instances.  
           [0005]    Breard et al. U.S. Pat. No. 5,011,484 issued Apr. 30, 1991 discloses an artificial ligament used with an elongate insert. A couple of types of systems, one including rods and another including inextensible strips or inextensible bands, are mentioned as background in U.S. Pat. No. 5,725,582 issued Mar. 10, 1998 to Bevan et al. One such mentioned system is to loop inextensible flexible members directly around spinous processes. The Bevan et al. patent discloses a proposed simplification of the loop procedure, by simply winding the band around spinous processes of adjacent vertebrae as in FIGS. 1 and 2 of that patent, and then tensioning and crimping them. Bevan et al. shows other versions which involve pedicle screws and hooks. The Howland et al. U.S. Pat. No. 5,496,318 uses an arrangement mounted on spinous processes and has a retaining belt  124 . Lumb et al. U.S. Pat. No. 3,648,691 uses flexible multi-apertured straps  28  clamped on opposite sides of spinous processes. Vinylidene flouride is given as an example of the strap material and is said to be preferred over machined metal straps. The Kapp et al. U.S. Pat. No. 4,554,914 discloses a pair of elongate plates  28  and  30  clamped onto the spinal processes by bolts through holes drilled in the spinal processes. The Samani U.S. Pat. No. 5,645,599 employs a U-shaped body preferably made of titanium forged in one piece and having upper and lower generally U-shaped brackets with holes therein. The brackets are receivable on spinous processes of adjacent vertebrae and have holes therein to receive bone screws or spikes engaged in the spinous processes and crimped in the holes to anchor the implant thereon.  
           [0006]    In our view, and to various degrees, these systems involve one or more of a variety of shortcomings such as size, the necessity of large incisions, difficult manipulation, difficult or excessive drilling or sawing of bone, and permanence and reliability of fixation in association with anterior lumbar interbody fusion (ALIF) procedures. The present invention is directed to overcoming one or more shortcomings encountered with current fixation devices and systems following such procedures.  
         SUMMARY OF THE INVENTION  
         [0007]    Described briefly, according to a typical embodiment of the present invention, a fixation device for use in association with ALIF procedures includes a couple of spaced plates having integral spikes on facing surfaces thereof for pressing into spinal processes of adjacent vertebrae. One of the plates has a socket which captures one end of a post which is received through an aperture in the other plate. The socket mounting is arranged to enable the post to pivot therein for at least two degrees of freedom to a limited extent enabling angulation between the two plates so as to accommodate the different thicknesses and orientations of the spinal processes on adjacent vertebrae. The reception of the post in the second plate enables adjustment of spacing between the plates to accommodate effective installation of the assembly on the spinal processes by a compression instrument, and permanent reliable maintenance of that spacing following removal of the compression instrument. The cross-sectional configuration of the post and a receiver aperture in the plate inhibits rotation of the plate relative to the post about the post axis.  
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0008]    [0008]FIG. 1 is a posterior view of a portion of the spine with the device of the present invention fixed in place following anterior lumbar interbody fusion procedure.  
         [0009]    [0009]FIG. 2 is a lateral view of the instrumentation of FIG. 1.  
         [0010]    [0010]FIG. 3 is a perspective view of the device itself prior to installation.  
         [0011]    [0011]FIG. 4 is a view of the inner face of the head plate with the cross-post secured in a socket therein and the assembly viewed along the longitudinal axis of the cross-post.  
         [0012]    [0012]FIG. 5 is a view of the inner face of the head plate without the cross-post, so the post head socket is vacant.  
         [0013]    [0013]FIG. 6 is a section through the head plate itself taken at line  6 - 6  in FIG. 5 and viewed in the direction of the arrows.  
         [0014]    [0014]FIG. 7 is a view of the cross-post.  
         [0015]    [0015]FIG. 8 is an end view of the cross-post taken at line  8 - 8  in FIG. 7 and viewed in the direction of the arrows.  
         [0016]    [0016]FIG. 9 is a section taken through the assembly of FIG. 3 on the axis of the cross-post and viewed in a plane containing the axis of the cross-post and set screw and viewed in the direction of the arrows  9 - 9 .  
         [0017]    [0017]FIG. 10 is an enlarged elevational view of the breakoff set screw.  
         [0018]    [0018]FIG. 11 is a view of the inner face of the locking plate viewed in the direction of the axis of the cross-post receiving aperture.  
     
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0019]    For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the embodiment illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated device, and such further applications of the principles of the invention as illustrated therein being contemplated as would normally occur to one skilled in the art to which the invention relates.  
         [0020]    Referring now to the drawings in detail, particularly FIGS. 3 and 9, the device  11  according to the illustrated embodiment of the present invention, is clamped to the spinal processes of the L4 and L5 vertebrae. The device comprises a head plate  12 , a locking plate  13 , and a cross-post  14  having a head  16  received in a socket  17  in the head plate, and a distal end  18  received through an aperture  19  in the locking plate. The inboard or inside surface  12 A of plate  12  facing the inside or inboard face  13 A of plate  13 , has a plurality of spikes  19  facing similar spikes  21  on the inside face  13 A of plate  13 . These spikes are embedded in the spinal processes when the device is compressed in place and so clamps the adjacent vertebrae.  
         [0021]    The cross-post has a cylindrical cross- sectional shape but with a flat surface  14 F extending the length of the post  14 . A set screw  22  is threaded into the locking plate. The inner end of the set screw bears on the flat  14 F on the post to lock the plate to the post after fixation of the plates to the spinal processes by a compression instrument. Various spinal compression tools available on the market may be used. Part-spherical recesses  26  (FIG. 6) are provided in the outboard or back face of head plate  12 . Similar part-spherical recesses  27  (FIG. 3) are provided in the outboard or back face of the locking plate. These recesses facilitate placement of tips of a compression tool and retention of the tool onto the plates during compression of the plates onto the spinal processes.  
         [0022]    Referring now to FIGS. 7 and 8, the cross-post  14  is cylindrical, has a spherical head  16  at one end, and the distal end  18  is rounded. While the flat  14 F subtends a very narrow arc of the cylindrical surface of the post, it provides a relatively deep groove or notch  14 N in the head  16 . As an example, where the post head is 7.14 mm in diameter, and the post diameter is 4.49 mm, the dimension  14 H (FIG. 8) on a diametrical line in plane  14 P bisecting the flat and groove  14 N is 4.29 mm, and the width  14 W (FIG. 7) of the slot, groove or notch  14 N in the post head is 2.353 mm.  
         [0023]    [0023]FIG. 11 is a view of the inboard face  13 A of the locking plate, viewed along the axis of the aperture  19 . A flat  19 F is shown at the top of the aperture. This aperture  19  is thus shaped to provide a sliding, non-rotating fit between the plate and the cross-post. The flats on the post and in the hole  19  are interruptions in the circular form of the post and hole. The post and hole could be of some other cross sectional shape providing a slip fit but avoiding rotation of the locking plate relative to the post. For example, polygonal or key and keyway shapes could be used.  
         [0024]    Referring back to FIG. 4, along with FIGS. 6 and 9, the head plate  12  is viewed facing the inboard surface  12 A and looking along the axis  14 A of the cross-post  14 . The post head  16  is shown received in the socket  17 . A snap ring  31  is received in a groove  12 G (FIG. 6) at the entrance to the socket  17  and retains the post head  16  in the socket. It was mentioned above that the matching surfaces of the cross-post and the post receiving hole  19  in the locking plate prevent rotation of the plate relative to the post. At the head plate end of the cross-post, a cylindrical pin  32  press-fitted in a hole  33  (FIGS. 6 and 9) in the head plate, projects into the groove  14 N of the cross-post head. As shown in FIG. 4, a narrow space is allowed between each side of the groove and the wall of the pin  32 . This permits a very narrow angle (maximum five degrees total) of rotation of the head plate relative to the cross-post about the cross-post axis  14 A.  
         [0025]    At the opposite end of the cross-post, a blind hole  13 B extends from the top edge of the locking plate through the aperture  19  in the plate. The upper portion of the hole  13 B is of greater diameter and tapped with internal threads to receive the external threads  22 T of set screw  22 . The screw is shown in FIG. 9 as tightly engaging the flat surface  14 F of the cross-post. As shown in FIGS. 3 and 9, the set screw has an upper or outboard head portion  22 U with flutes  22 F exposed at the upper end of the screw to receive a screw installation tool. There is also a set of flutes  22 K (FIG. 9) at the inboard end of the set screw. Each of the two sets of flutes can accommodate a six fluted tool but, of course, of different diameters. At the lower end of the necked-down portion  22 N of the set screw, there is an annular notch  22 B whereby, following installation and adequate tightening of the set screw, the head can be broken off from the threaded portion to minimize bulk at the outboard edge  13 C of plate  13 .  
         [0026]    Referring further to FIG. 9, it should be understood that in the preferred embodiment, the radius of the spherical portion of the socket is the same as the radius of the spherical head on the cross post. In FIG. 9 there appears to be a space between the socket and the post head at the top. This is because of the cut in the post head providing the slot  14 N.  
         [0027]    It should also be noted in FIG. 9 that the snap ring  31  has two chamfers  31 A and  31 B at the hole through it and extending inward from each face of the snap ring. The chamfers may be flat, but are preferably concave, with a radius the same as that of the post head. In this way, it does not matter which way the snap ring is installed in the groove  12 G after the post head is inserted in the socket in the pre-assembly of the device. Also, with the chamfer having a slight concavity of the same radius as the post head, the post head can fittingly seat on the snap ring to resist any tendency of the plates to separate following the installation and compression on the spinous processes, and the locking of plate  13  in place with the set screw.  
         [0028]    As indicated above, the provision of the socket in the head plate  12 , with the post head being swivel mounted in the socket, enables some movement of the plate relative to the axis  14 A of the post. The width of the slot  14 N, being slightly greater than the diameter of the anti-rotation pin  32 , enables a very limited amount (a narrow angle less than five degrees) of rotation of the plate relative to the post about the post axis. Thus, it keeps the plates parallel to each other during insertion of the implant into the patient&#39;s back, and during compression of the spikes into the spinal processes, and during clamping of the set screw onto the flat surface  14 F of the post. But the head plate also has the capability of angulation relative to the locking plate within an axial (horizontal) plane such as, for example, the plane containing the axis  14 A of the post and the axis  32 A of pin  32 . The plane of the paper for FIG. 9 is an example. Stated in other terms, consider line  6 - 6  in FIG. 5 to be the longitudinal axis of plate  12 . The plate can turn or rotate about this axis up to twenty-five degrees each side of the center of the socket  17 , or a total of fifty degrees maximum. The head plate  12  also can angulate relative to locking plate  12  within a coronal (vertical) plane such as, for example, containing the axis  14 A of the post and perpendicular to the axis of the pin  32 . The plane of the paper for FIGS. 1, 6 and  9 , is an example. Stated otherwise, consider a line through the center of the socket  17 , such as  32 A in plane  9 - 9 , and perpendicular to plane  6 - 6 , and to be the transverse axis of plate  12 . The plate  12  can rotate or turn about its transverse axis up to twenty-five degrees each side of the center of the socket.  
         [0029]    The device according to the present invention can be used for stabilization following an anterior lumbar interbody fusion procedure. At a suitable time associated with or following the placement of a construct in the interbody site, a small incision is made in the patient&#39;s back. The incision is of sufficient size to admit the device and instrumentation. Although angulation of the head plate relative to the post is possible to some extent, rotation of the plate relative to the post is very limited. Neither angulation nor rotation of the locking plate is possible relative to the post. Following the incision, muscle is moved aside if and as needed for placement of the plates. To minimize bulk prior to entry, the two plates can be placed as close together as the surgeon wishes, and the set screw snugged. If the plates have been installed with the spikes thereon touching each other, the set screw can be loosened to spread the plates for mounting on the spinal processes of the vertebrae adjacent the intervertebral construct site. Then the compression instrumentation is applied to press the plates toward each other, whereupon the spikes enter the spinal processes. Compression is continued until the spikes are fully seated. The angulation of the head plate relative to the post is sufficient (up to twenty-five degrees either side of the center line as indicated above), to enable enough adaptation of the plates to different thicknesses and shapes of the spinal processes of adjacent vertebrae, to enable full seating of the spikes in the spinal processes of the adjacent vertebrae. To minimize thickness of the head plate at socket  17 , while accommodating post head  16 , opening  12 E (FIGS. 5 and 6) is provided in the head plate. There is very little clearance between the sphere of the post head and the spherical cavity of the socket, providing a close but slidable fit. The opening  12 E enhances effectiveness of autoclave for sanitizing the post head and socket following assembly of the parts outside the patient and before implantation. Although not likely to be needed following the seating of the plates on the spinal processes, the post head end  16 E exposed in opening  12 E may be lightly pushed toward the snap ring in the direction of arrow  41  (FIG. 9), if needed.  
         [0030]    Following the full seating of the plates on the spinal processes, the set screw is tightened onto the flat  14 F of the cross-post, using a screwdriver with flutes fitting the outer set of flutes. Upon satisfaction of the surgeon, that the fixation is complete, additional torque is applied to break the head of the set screw away from the threaded portion, and the set screw head is discarded. Then the site is closed up, completing the stabilization procedure. The set screw reliably maintains the clamping force of the plates on the spinous processes. If, at any time, it is decided to remove the device, the inner flutes can receive a smaller fluted head screwdriver to loosen the set screw.  
         [0031]    During the compression procedure, and being sure that the post is properly placed, the ability of the head plate  12  to tilt on the post  14  and angulate relative to the locking plate  13 , assists in assuring full seating of the spikes on both sides of both spinal processes. The ability of the head plate to tilt relative to the post is limited by engagement of the neck of the head against the inner edge of the snap ring  31 . Angulation of the plate relative to the post in any plane is limited by the snap ring edge at about twenty-five degrees each way from the post axis  14 A.  
         [0032]    The choice of whether the snap ring gap is located as shown in FIG. 4 or on the opposite side of the axis of the post in FIG. 4, or at forty-five degrees up or down from horizontal, may depend upon what the surgeon&#39;s impression is of where the strict limitation on angulation should be focused.  
         [0033]    While the illustrated example of the device is applied to L-4 and L-5, the device can be implanted on spinous processes at other levels. Levels up to T-3 may be appropriate sites. Also, plates bridging more than one level may also be considered. The shape of the plates may be different at different levels. The virtually identical perimeter edge concavo/convex shape and size of the illustrated plates  12  and  13 , conforms generally to the lordotic curve in the lumbar region. In this example, the concave edge  12 C and convex edge  12 X have a common center remote from the plates and in the plane of the face  12 A of the plate. This common center is on a transverse axis of the plate such as mentioned above and which lies on a radius of the center of socket  17  to the common center of curvature of edges  12 C and  12 X. Plate faces other than flat may be used. Edge shapes other than the banana-shaped profile shown, may be used. Various bio-compatible materials can be used. Titanium-6A- 4 V ASTM F-136 is an example of plate, pin, post, lock ring, and screw material. Other materials may be used.  
         [0034]    The fact that the entire device can be assembled outside the body prior to implantation, but without excessive bulk inhibiting implantation, can be quite helpful in avoiding a multi-component device requiring assembly inside the body. The integral approach reduces the size of the incision required for implantation. Even though the device is pre-assembled, it provides for the plates to angulate relative to each other in two planes, allowing the device to adapt to variations in spinous process thickness and geometry. Use of the integral spikes, rather than screws or shapes which require notching or other treatment of the spinous processes, simplifies the stabilization of the spinous processes following the ALIF. The incorporation of the cross-post in a secure way in the one plate, avoids the need for the use of separate bolt and cable to join plates.  
         [0035]    While the invention has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character, it being understood that only the preferred embodiment has been shown and described and that all changes and modifications that come within the spirit of the invention are desired to be protected.