Patent Abstract:
An intervertebral spacer device includes a first plate having a bone engaging face and an inner face, and a second plate having a second bone engaging face and a second inner face, the first and second plates being juxtaposed with one another so that the first inner face of the first plate opposes the second inner face of the second plate. The spacer device also includes a belleville washer disposed between the first inner face of the first plate and the second inner face of the second plate for counteracting compressive loads applied to the first and second plates. The belleville washer has at least one concentric groove and at least one spiral slot, whereby the at least one concentric groove has a depth and a width, with at least one of the widths and the depths varying along the length of the at least one concentric groove.

Full Description:
CROSS-REFERENCE TO RELATED APPLICATION  
       [0001]     The present application is a continuation of U.S. patent application Ser. No. 09/975,471, filed Oct. 11, 2001, now allowed, which is a continuation-in-part of U.S. patent application Ser. No. 09/789,936, filed Feb. 15, 2001, now abandoned, the disclosures of which are hereby incorporated by reference herein. 
     
    
     FIELD OF THE INVENTION  
       [0002]     This invention relates generally to a spinal implant assembly for implantation into the intervertebral space between adjacent vertebral bones to simultaneously provide stabilization and continued flexibility and proper anatomical motion, and more specifically to such a device which utilizes a spirally slotted belleville washer, having radially spaced concentric grooves, as a restoring force generating element.  
       BACKGROUND OF THE INVENTION  
       [0003]     The bones and connective tissue of an adult human spinal column consists of more than 20 discrete bones coupled sequentially to one another by a tri-joint complex which consists of an anterior disc and the two posterior facet joints, the anterior discs of adjacent bones being cushioned by cartilage spacers referred to as intervertebral discs. These more than 20 bones are anatomically categorized as being members of one of four classifications: cervical, thoracic, lumbar, or sacral. The cervical portion of the spine, which comprises the top of the spine, up to the base of the skull, includes the first 7 vertebrae. The intermediate 12 bones are the thoracic vertebrae, and connect to the lower spine comprising the 5 lumbar vertebrae. The base of the spine is the sacral bones (including the coccyx). The component bones of the cervical spine are generally smaller than those of the thoracic spine, which are in turn smaller than those of the lumbar region. The sacral region connects laterally to the pelvis. While the sacral region is an integral part of the spine, for the purposes of fusion surgeries and for this disclosure, the word spine shall refer only to the cervical, thoracic, and lumbar regions.  
         [0004]     The spinal column of bones is highly complex in that it includes over twenty bones coupled to one another, housing and protecting critical elements of the nervous system having innumerable peripheral nerves and circulatory bodies in close proximity. In spite of these complications, the spine is a highly flexible structure, capable of a high degree of curvature and twist in nearly every direction.  
         [0005]     Genetic or developmental irregularities, trauma, chronic stress, tumors, and degenerative wear are a few of the causes that can result in spinal pathologies for which surgical intervention may be necessary. A variety of systems have been disclosed in the art which achieve immobilization and/or fusion of adjacent bones by implanting artificial assemblies in or on the spinal column. The region of the back which needs to be immobilized, as well as the individual variations in anatomy, determine the appropriate surgical protocol and implantation assembly. With respect to the failure of the intervertebral disc, the interbody fusion cage has generated substantial interest because it can be implanted laparoscopically into the anterior of the spine, thus reducing operating room time, patient recovery time, and scarification.  
         [0006]     Referring now to  FIGS. 1 and 2 , in which a side perspective view of an intervertebral body cage and an anterior perspective view of a post implantation spinal column are shown, respectively, a more complete description of these devices of the prior art is herein provided. These cages  10  generally comprise tubular metal body  12  having an external surface threading  14 . They are inserted transverse to the axis of the spine  16 , into preformed cylindrical holes at the junction of adjacent vertebral bodies (in  FIG. 2  the pair of cages  10  are inserted between the fifth lumbar vertebra (L 5 ) and the top of the sacrum (S 1 ). Two cages  10  are generally inserted side by side with the external threading  14  tapping into the lower surface of the vertebral bone above (L 5 ), and the upper surface of the vertebral bone (S 1 ) below. The cages  10  include holes  18  through which the adjacent bones are to grow. Additional material, for example autogenous bone graft materials, may be inserted into the hollow interior  20  of the cage  10  to incite or accelerate the growth of the bone into the cage. End caps (not shown) are often utilized to hold the bone graft material within the cage  10 .  
         [0007]     These cages of the prior art have enjoyed medical success in promoting fusion and grossly approximating proper disc height. It is, however, important to note that the fusion of the adjacent bones is an incomplete solution to the underlying pathology as it does not cure the ailment, but rather simply masks the pathology under a stabilizing bridge of bone. This bone fusion limits the overall flexibility of the spinal column and artificially constrains the normal motion of the patient. This constraint can cause collateral injury to the patient&#39;s spine as additional stresses of motion, normally borne by the now-fused joint, are transferred onto the nearby facet joints and intervertebral discs. It would therefore, be a considerable advance in the art to provide an implant assembly which does not promote fusion, but, rather, which nearly completely mimics the biomechanical action of the natural disc cartilage, thereby permitting continued normal motion and stress distribution.  
         [0008]     It is, therefore, an object of the present invention to provide a new and novel intervertebral spacer which stabilizes the spine without promoting a bone fusion across the intervertebral space.  
         [0009]     It is further an object of the present invention to provide an implant device which stabilizes the spine while still permitting normal motion.  
         [0010]     It is further an object of the present invention to provide a device for implantation into the intervertebral space which does not promote the abnormal distribution of biomechanical stresses on the patient&#39;s spine.  
         [0011]     Other objects of the present invention not explicitly stated will be set forth and will be more clearly understood in conjunction with the descriptions of the preferred embodiments disclosed hereafter.  
       SUMMARY OF THE INVENTION  
       [0012]     The preceding objects of the invention are achieved by the present invention which is a flexible intervertebral spacer device comprising a pair of spaced apart base plates, arranged in a substantially parallel planar alignment (or slightly offset relative to one another in accordance with proper lordotic angulation) and coupled to one another by means of a spring mechanism. In particular, this spring mechanism provides a strong restoring force when a compressive load is applied to the plates, and may also permit rotation of the two plates relative to one another. While there are a wide variety of embodiments contemplated, a preferred embodiment includes a belleville washer utilized as the restoring force providing element, the belleville washer being spirally slotted and having radially spaced concentric grooves.  
         [0013]     More particularly, as the assembly is to be positioned between the facing surfaces of adjacent vertebral bodies, the base plates should have substantially flat external surfaces which seat against the opposing bone surfaces. Inasmuch as these bone surfaces are often concave, it is anticipated that the opposing plates may be convex in accordance with the average topology of the spinal anatomy. In addition, the plates are to mate with the bone surfaces in such a way as to not rotate relative thereto. (The plates rotate relative to one another, but not with respect to the bone surfaces to which they are each in contact with.) In order to prevent rotation of a plate relative to the bone, the upper and lower plates can include a porous coating into which the bone of the vertebral body can grow. (Note that this limited fusion of the bone to the base plate does not extend across the intervertebral space.)  
         [0014]     In some embodiments (not in the preferred embodiment), between the base plates, on the exterior of the device, there is included a circumferential wall which is resilient and which simply prevents vessels and tissues from entering within the interior of the device. This resilient wall may comprise a porous fabric or a semi-impermeable elastomeric material. Suitable tissue compatible materials meeting the simple mechanical requirements of flexibility and durability are prevalent in a number of medical fields including cardiovascular medicine, wherein such materials are utilized for venous and arterial wall repair, or for use with artificial valve replacements. Alternatively, suitable plastic materials are utilized in the surgical repair of gross damage to muscles and organs. Still further materials that could be utilized herein may be found in the field of orthopedic in conjunction with ligament and tendon repair. It is anticipated that future developments in this area will produce materials that are compatible for use with this invention, the breadth of which shall not be limited by the choice of such a material.  
         [0015]     As introduced above, the internal structure of the present invention comprises a spring member, which provides a restoring force when compressed. More particularly, it is desirable that the restoring forces be directed outward against the opposing plates, when a compressive load is applied to the plates. In addition, in certain embodiments, it is necessary that the restoring force providing subassembly not substantially interfere with the rotation of the opposing plates relative to one another. In the preferred embodiment, the spring subassembly is configured to allow rotation of the plates relative to one another. In other embodiments, the spring subassembly can be configured to either allow rotation of the plates, or prevent rotation of the plates (through the tightening of a set screw as discussed below). As further mentioned above, the force restoring member comprises at least one belleville washer.  
         [0016]     Belleville washers are washers which are generally bowed in the radial direction. Specifically, they have a radial convexity (i.e., the height of the washer is not linearly related to the radial distance, but may, for example, be parabolic in shape). The restoring force of a belleville washer is proportional to the elastic properties of the material. In addition, the magnitude of the compressive load support and the restoring force provided by the belleville washer may be modified by providing slots and/or grooves in the washer. In the preferred embodiment of the present invention, the belleville washer utilized as the force restoring member is spirally slotted, with the slots initiating on the periphery of the washer and extending along arcs which are generally radially inwardly directed a distance toward the center of the bowed disc, and has radially uniformly spaced concentric grooves of uniform width and depth.  
         [0017]     As a compressive load is applied to a belleville washer, the forces are directed into a hoop stress which tends to radially expand the washer. This hoop stress is counterbalanced by the material strength of the washer, and the strain of the material causes a deflection in the height of the washer. Stated equivalently, a belleville washer responds to a compressive load by deflecting compressively, but provides a restoring force which is proportional to the elastic modulus of the material in a hoop stressed condition. With slots and/or radially spaced concentric grooves formed in the washer, it expands and restores itself far more elastically than a solid washer.  
         [0018]     In general, the belleville washer is one of the strongest configurations for a spring, and is highly suitable for use as a restoring force providing subassembly for use in an intervertebral spacer element which must endure considerable cyclical loading in an active human adult.  
         [0019]     In the preferred embodiment of the present invention, a single modified belleville washer, which is of the slotted variety and has radially spaced concentric grooves as described above, is utilized in conjunction with a ball-shaped post on which it is free to rotate through a range of angles (thus permitting the plates to rotate relative to one another through a corresponding range of angles). More particularly, this embodiment comprises a pair of spaced apart base plates, one of which is simply a disc shaped member (preferably shaped to match the end of an intervertebral disc) having an external face (having the porous coating discussed above) and an internal face having an annular retaining wall (the purpose of which will be discussed below). The other of the plates is similarly shaped, having an exterior face with a porous coating, but further includes on its internal face a central post portion which rises out of the internal face at a nearly perpendicular angle. The top of this post portion includes a ball-shaped knob. The knob includes a central threaded axial bore which receives a small set screw. Prior to the insertion of the set screw, the ball-shaped head of the post can deflect radially inward (so that the ball-shaped knob contracts). The insertion of the set screw eliminates the capacity for this deflection.  
         [0020]     As introduced above, a modified and spirally slotted belleville washer having radially spaced concentric grooves is mounted to this ball-shaped knob in such a way that it may rotate freely through a range of angles equivalent to the fraction of normal human spine rotation (to mimic normal disc rotation). The belleville washer of this design is modified by including an enlarged inner circumferential portion (at the center of the washer) which accommodates the ball-shaped portion of the post. More particularly, the enlarged portion of the modified belleville washer includes a curvate volume having a substantially constant radius of curvature which is also substantially equivalent to the radius of the ball-shaped head of the post. The deflectability of the ball-shaped head of the post, prior to the insertion of the set screw, permits the head to be inserted into the interior volume at the center of the belleville washer. Subsequent introduction of the set screw into the axial bore of the post prevents the ball-shaped head from deflecting. Thereby, the washer can be secured to the ball-shaped head so that it can rotate thereon through a range of proper lordotic angles (in some embodiments, a tightening of the set screw locks the washer on the ball-shaped head at one of the lordotic angles).  
         [0021]     This assembly provides ample spring-like performance with respect to axial compressive loads, as well as long cycle life to mimic the axial biomechanical performance of the normal human intervertebral disc. The spiral slots and radially spaced concentric grooves of the belleville washer allow the washer to expand radially as the slots and grooves widen under the load, only to spring back into its undeflected shape upon the unloading of the spring. As the washer compresses and decompresses, the annual retaining wall maintains the wide end of the washer within a prescribed boundary on the internal face of the base plate which it contacts, and an annular retaining ring maintains the wide end of the washer against the internal face.  
         [0022]     Finally, inasmuch as the human body has a tendency to produce fibrous tissues in perceived voids, such as may be found within the interior of the present invention, and such fibrous tissues may interfere with the stable and/or predicted functioning of the device, some embodiments of the present invention (although not the preferred embodiment) will be filled with a highly resilient elastomeric material. The material itself should be highly biologically inert, and should not substantially interfere with the restoring forces provided by the spring-like mechanisms therein. Suitable materials may include hydrophilic monomers such as are used in contact lenses. Alternative materials include silicone jellies and collagens such as have been used in cosmetic applications. As with the exterior circumferential wall, which was described above as having a variety of suitable alternative materials, it is anticipated that future research will produce alternatives to the materials described herein, and that the future existence of such materials which may be used in conjunction with the present invention shall not limit the breadth thereof. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0023]      FIG. 1  is a side perspective view of an interbody fusion device of the prior art.  
         [0024]     BRIEF  FIG. 2  is a front view of the anterior portion of the lumbo-sacral region of a human spine, into which a pair of interbody fusion devices of the type shown in  FIG. 1  have been implanted.  
         [0025]      FIGS. 3   a  and  3   b  are side cross-section views of the upper and lower opposing plates of the preferred embodiment of the present invention.  
         [0026]      FIGS. 4   a  and  4   b  are top and side cross-section view of a belleville washer having radially uniformly spaced concentric grooves of uniform width and depth and spiral slots, for use in a preferred embodiment of the present invention.  
         [0027]      FIGS. 5   a - 5   c  are top and side cross-section views of a belleville washer having radially non-uniformly spaced concentric grooves of varying width and depth and spiral slots, for use in an alternate embodiment of the present invention.  
         [0028]      FIG. 6   a  is a top view of the upper plate of  FIG. 3   a , with the belleville washer of  FIGS. 4   a  and  4   b  fitted within a retaining wall and a retaining ring of the upper plate.  
         [0029]      FIG. 6   b  is a top view of the lower plate of  FIG. 3   b.    
         [0030]      FIG. 7  is a side cross-section view of the preferred embodiment of the present invention, which utilizes a belleville washer of the type shown in  FIGS. 4   a  and  4   b , showing the plates of  FIGS. 6   a  and  6   b  assembled together.  
         [0031]      FIG. 8   a  is a top view of the upper plate of  FIG. 3   a , with the belleville washer of  FIGS. 5   a - 5   c  fitted within a retaining wall and a retaining ring of the upper plate.  
         [0032]      FIG. 8   b  is a top view of the lower plate of  FIG. 3   b.    
         [0033]      FIG. 9  is a cross-section view of an alternate embodiment of the present invention, which utilizes a belleville washer of the type shown in  FIGS. 5   a - 5   c , showing the plates of  FIGS. 8   a  and  8   b  assembled together.  
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0034]     While the present invention will be described more fully hereinafter with reference to the accompanying drawings, in which particular embodiments and methods of implantation are shown, it is to be understood at the outset that persons skilled in the art may modify the invention herein described while achieving the functions and results of this invention. Accordingly, the descriptions which follow are to be understood as illustrative and exemplary of specific structures, aspects and features within the broad scope of the present invention and not as limiting of such broad scope. Like numbers refer to similar features of like elements throughout.  
         [0035]     Referring now to  FIGS. 3   a  and  3   b , side cross-section views of upper and lower plate members  100 , 200  of the preferred embodiment of the present invention are shown. As the device is designed to be positioned between the facing surfaces of adjacent vertebral bodies, the plates include substantially flat external face portions  102 , 202  which seat against the opposing bone surfaces. In addition, the plates are to mate with the bone surfaces in such a way as to not rotate relative thereto. It is, therefore, preferred that the external faces of the plates include a porous coating  104 , 204  into which the bone of the vertebral body can grow. (Note that this limited fusion of the bone to the base plate does not extend across the intervertebral space.) A hole (not shown) can be provided in the upper plate such that the interior of the device may be readily accessed if a need should arise.  
         [0036]     The upper plate  100  includes an internal face  103  that includes an annular retaining wall  108  and an annular retaining ring  109 . The lower plate  200  includes an internal face  203  that includes a central post member  201  which rises out of the internal face  203  at a nearly perpendicular angle. The top of this post member  201  includes a ball-shaped head  207 . The head  207  includes a series of slots which render it compressible and expandable in correspondence with a radial pressure (or a radial component of a pressure applied thereto). The head  207  includes a central threaded axial bore  209  which extends down the post  201 . This threaded bore  209  is designed to receive a set screw  205 . Prior to the insertion of the set screw  205 , the ball-shaped head  207  of the post  201  can deflect radially inward because of the slots (so that the ball-shaped head contracts). The insertion of the set screw  205  eliminates the capacity for this deflection.  
         [0037]     Referring now to  FIGS. 4   a  and  4   b , a spirally slotted belleville washer  130  having radially spaced concentric grooves is provided in top and side cross-section views. The belleville washer  130  is a restoring force providing device which comprises a circular shape, having a central opening  132 , and which is radially arched in shape. The belleville washer  130  has a radial convexity  134  (i.e., the height of the washer  130  is not linearly related to the radial distance, but may, for example, be parabolic in shape). The restoring force of the belleville washer  130  is proportional to the elastic properties of the material.  
         [0038]     The belleville washer  130  comprises a series of spiral slots  131  formed therein. The slots  131  extend from the outer edge of the belleville washer, inward along arcs generally directed toward the center of the element. The slots  131  do not extend fully to the center of the element. In preferred embodiments, the slots may extend anywhere from a quarter to three quarters of the overall radius of the washer, depending upon the requirements of the patient, and the anatomical requirements of the device.  
         [0039]     The belleville washer  130  further comprises a series of grooves  133  formed therein. The grooves  133  are concentric and radially spaced from the outer edge of the belleville washer toward the center of the element. In the preferred embodiment shown in  FIGS. 4   a  and  4   b , the width  135  of each groove  133  is uniform along the length of the groove  133 . Further in the preferred embodiment, the depth  137  of each groove  133  is uniform along the length of the groove  133 . Further in the preferred embodiment, each groove  133  has a different width configuration and a different depth configuration than each other groove  133 . More specifically, in the preferred embodiment, the width dimension and the depth dimension both vary from groove to groove, each increasing incrementally from groove to adjacent groove with increasing distance from the center of the washer  130 . Stated alternatively, grooves that are relatively more narrow and more shallow than the other grooves are closer to the center of the washer, whereas grooves that are relatively wider and deeper than the other grooves are closer to the outer edge of the washer. This is illustrated by example in  FIGS. 4   a  and  4   b , which show three concentric grooves  133   a - c , with the outermost groove  133   c  being deeper and wider than groove  133   b , which is in turn deeper and wider than groove  133   a . Further in the preferred embodiment, the radial spacing of the grooves is uniform.  
         [0040]     It should be understood that in other embodiments, one or both of the depth and the width of each groove can be (1) increasing along the length of the groove, (2) decreasing along the length of the groove, or (3) varied along the length of each groove, either randomly or according to a pattern. Moreover, in other embodiments, it can be the case that each groove is not formed similarly to one or more other grooves, with or without respect to width and depth dimensions, but rather one or more grooves are formed in any of the above-mentioned fashions, while one or more other grooves are formed in another of the above-mentioned fashions or other fashions. Also, in other embodiments, it can be the case that the radial distance between the grooves is not the same, but rather the spacing increases the closer the space is to the outer edge of the washer, decreases the closer the space is to the outer edge of the washer, or varies either randomly or according to a pattern. Also, while the grooves of the preferred embodiment and the illustrated alternate embodiment have lengths that form closed loops, it should be noted that in other embodiments, the concentric grooves can have lengths that form open loops or arcs; for example, a two concentric grooves forming open loops or arcs can be used in place of a single concentric groove forming a closed loop. It should be clear that any concentric groove pattern can be implemented without departing from the scope of the present invention. To illustrate an alternate embodiment showing an alternate radially spaced concentric groove pattern,  FIGS. 5   a - 5   c  show a belleville washer  130  having radially spaced concentric grooves  133  in top and side cross-section views, with each groove  133  having a width and a depth each varying along the length of the groove  133 , with each groove  133  being formed differently than at least one other groove  133 , with the radial spacing of the grooves  133  being varied, and with both closed loops and open loops or arcs being used. In this alternate embodiment, the difference between the grooves  133  is characterized in that the wider and deeper portion of any particular groove  133  is on a different side of the washer  130  than the wider and deeper portion of at least one other groove  133 .  
         [0041]     As a compressive load is applied to the belleville washer  130  of the present invention, the forces are directed into a hoop stress which tends to radially expand the washer. This hoop stress is counterbalanced by the material strength of the washer, and the force necessary to widen the spiral slots  131  and the radially spaced concentric grooves  133  along with the strain of the material causes a deflection in the height of the washer. Stated equivalently, the belleville washer  130  responds to a compressive load by deflecting compressively; the spiral slots and/or radially spaced concentric grooves cause the washer to further respond to the load by spreading as the slots and/or the grooves in the washer expand under the load. The spring, therefore, provides a restoring force which is proportional to the elastic modulus of the material in a hoop stressed condition.  
         [0042]     More particularly, the central opening  132  of the belleville washer is enlarged. This central opening  132  includes a curvate volume  233  for receiving therein the ball-shaped head  207  of the post  201  of the lower plate  200  described above. More particularly, the curvate volume  233  has a substantially constant radius of curvature which is also substantially equivalent to the radius of the ball-shaped head  207  of the post  201 . In this embodiment, the spiral slots  131  do not extend all the way to the central opening  132 , and approach the opening only as far as the material strength of the washer can handle without plastically deforming under the expected anatomical loading. Preferably, the center of the washer is flat; therefore, the central opening  132  can be formed from flat edges. It should be understood that this is not required, but rather is preferred.  
         [0043]     Referring now to  FIG. 6   a , a top view of the upper plate  100  of  FIG. 3   a , with the spirally slotted and concentrically grooved belleville washer  130  of  FIGS. 4   a  and  4   b  fitted within a retaining wall  108  and a retaining ring  109  of the upper plate  100 , is shown. The diameter of the retaining wall  108  is preferably slightly wider than the diameter of the undeflected belleville washer  130  such that the loading thereof can result in an unrestrained radial deflection of the washer  130 .  FIG. 6   b  shows a top view of the lower plate  200  of  FIG. 3   b.    
         [0044]      FIG. 7  shows the fully assembled preferred embodiment of the present invention. The spirally slotted and radially grooved belleville washer  130  of  FIGS. 4   a  and  4   b  is placed with its wide end against the top plate  100  within the annular retaining wall  108  as shown in  FIG. 6   b . The annular retaining ring  109  is provided to hold the belleville washer  130  against the internal face  103  of the upper plate  100  within the retaining wall  108 . The post  201  of the lower plate  200  is fitted into the central opening  132  of the belleville washer  130  (the deflectability of the ball-shaped head  207  of the post  201 , prior to the insertion of the set screw  205 , permits the head  207  to be inserted into the interior volume  233  at the center of the belleville washer  130 . Subsequent introduction of the set screw  205  into the axial bore  209  of the post  201  eliminates the deflectability of the head  207  so that the washer  130  cannot be readily removed therefrom, but can still rotate thereon. In some embodiments (not in this preferred embodiment), the post head  207  can be locked tightly within the central volume  233  of the belleville washer  130  by the tightening of the set screw  205 , to prevent any rotation of the plates  100 , 200 . Compressive loading of the assembly causes the washer  130  to deflect (with the spiral slots and the radially spaced concentric grooves enhancing the deflection) so that the wide end radially expands while being maintained centrally against the upper plate  100  by the retaining wall  108  and the retaining ring  109 . When the load is removed, the washer  130  springs back to its original shape.  
         [0045]     Referring now to  FIG. 8   a , a top view of the upper plate  100  of  FIG. 3   a , with the spirally slotted and concentrically grooved belleville washer  130  of  FIGS. 5   a - 5   c  fitted within a retaining wall  108  and a retaining ring  109  of the upper plate  100 , is shown. The diameter of the retaining wall  108  is preferably slightly wider than the diameter of the undeflected belleville washer  130  such that the loading thereof can result in an unrestrained radial deflection of the washer  130 .  FIG. 8   b  shows a top view of the lower plate  200  of  FIG. 3   b.    
         [0046]      FIG. 9  shows a fully assembled alternate embodiment of the present invention. The spirally slotted and concentrically grooved belleville washer  130  of  FIGS. 5   a - 5   c  is placed with its wide end against the top plate  100  within the annular retaining wall  108  as shown in  FIG. 6   b . The annular retaining ring  109  is provided to hold the belleville washer  130  against the internal face  103  of the upper plate  100  within the retaining wall  108 . The post  201  of the lower plate  200  is fitted into the central opening  132  of the belleville washer  130  (the deflectability of the ball-shaped head  207  of the post  201 , prior to the insertion of the set screw  205 , permits the head  207  to be inserted into the interior volume  233  at the center of the belleville washer  130 , and the washer  130  to be rotated into the desired angulation; subsequent introduction of the set screw  205  into the axial bore  209  of the post  201  eliminates the deflectability of the head  207  so that the washer  130  cannot be readily removed therefrom, but can still rotate thereon.). The post head  207  can be locked tightly within the central volume  233  of the belleville washer  130  by the tightening of the set screw  205 , to prevent any rotation of the plates  100 , 200 . Compressive loading of the assembly causes the washer  130  to deflect (with the spiral slots and radially spaced concentric grooves enhancing the deflection) so that the wide end radially expands while being maintained centrally against the upper plate  100  by the retaining wall  108  and the retaining ring  109 . When the load is removed, the washer  130  springs back to its original shape.  
         [0047]     Inasmuch as the human body has a tendency to produce fibrous tissues in perceived voids, such as may be found within the interior of the present invention, and such fibrous tissues may interfere with the stable and/or predicted functioning of the device, some embodiments of the present invention (although not the preferred embodiment) will be filled with a highly resilient and biologically inert elastomeric material. Suitable materials may include hydrophilic monomers such as are used in contact lenses. Alternative materials include silicone jellies and collagens such as have been used in cosmetic applications.  
         [0048]     While there has been described and illustrated specific embodiments of an intervertebral spacer device, it will be apparent to those skilled in the art that variations and modifications are possible without deviating from the broad spirit and principle of the present invention. The invention, therefore, shall not be limited to the specific embodiments discussed herein.

Technology Classification (CPC): 0