U.S. patent application number 14/242496 was filed with the patent office on 2014-10-09 for intervertebral spacer device.
This patent application is currently assigned to SPINECORE, INC.. The applicant listed for this patent is SpineCore, Inc.. Invention is credited to James D. Ralph, Stephen Tatar.
Application Number | 20140303734 14/242496 |
Document ID | / |
Family ID | 32869963 |
Filed Date | 2014-10-09 |
United States Patent
Application |
20140303734 |
Kind Code |
A1 |
Ralph; James D. ; et
al. |
October 9, 2014 |
INTERVERTEBRAL SPACER DEVICE
Abstract
An intervertebral spacer device includes a first plate and a
second plate, each plate having an outer surface for seating
against opposing vertebral bone surfaces. The device includes a
ball captured in a central opening of a coupling element, the
coupling element being maintained against the first plate by a
retaining ring coupled with the first plate.
Inventors: |
Ralph; James D.; (Bethlehem,
PA) ; Tatar; Stephen; (Montville, NJ) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
SpineCore, Inc. |
Allendale |
NJ |
US |
|
|
Assignee: |
SPINECORE, INC.
Allendale
NJ
|
Family ID: |
32869963 |
Appl. No.: |
14/242496 |
Filed: |
April 1, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11432196 |
May 11, 2006 |
8715349 |
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14242496 |
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|
10783292 |
Feb 18, 2004 |
7048763 |
|
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11432196 |
|
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|
09968047 |
Oct 1, 2001 |
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10783292 |
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Current U.S.
Class: |
623/17.16 |
Current CPC
Class: |
A61F 2220/0025 20130101;
A61F 2230/0065 20130101; A61F 2/30767 20130101; A61F 2002/30433
20130101; A61F 2220/0058 20130101; A61F 2002/30518 20130101; A61F
2002/30331 20130101; A61F 2/442 20130101; A61F 2002/30769 20130101;
A61F 2002/30649 20130101; A61F 2002/30774 20130101; A61F 2002/30538
20130101; A61F 2002/30565 20130101; A61F 2002/30604 20130101; A61F
2002/30909 20130101; A61F 2220/0041 20130101; A61F 2310/00017
20130101; A61F 2002/30563 20130101; A61F 2230/005 20130101; A61F
2002/30594 20130101; A61F 2/30742 20130101; A61F 2002/30507
20130101; A61F 2/4425 20130101; A61F 2002/30451 20130101; A61F
2002/302 20130101; A61F 2310/00365 20130101; A61F 2002/30171
20130101; A61F 2250/0006 20130101; A61F 2002/305 20130101; A61F
2002/443 20130101; A61F 2002/30975 20130101; A61F 2310/00023
20130101; A61F 2002/3092 20130101; A61F 2002/30571 20130101; A61F
2002/30492 20130101; A61F 2220/0033 20130101 |
Class at
Publication: |
623/17.16 |
International
Class: |
A61F 2/44 20060101
A61F002/44 |
Claims
1. An intervertebral spacer device for insertion into an
intervertebral space comprising: first and second members disposed
in a spaced apart relationship such that inner surfaces of the
first and second members oppose one another; a resilient element
articulably coupled to the second member; and a retaining ring
attached to the first member to hold the resilient element against
the inner surface of the first member.
2. The device of claim 1, wherein the resilient element has a
radially varying thickness such that the resilient element has a
non-linear load deflection profile after the intervertebral spacer
device is fully assembled for insertion into the intervertebral
space.
3-4. (canceled)
5. The device of claim 1, wherein the second member further
comprises a post to which the resilient element is articulably
coupled, the post extending from the inner surface thereof.
6. The device of claim 1, wherein the post further includes a
threaded bore which extends axially from the ball shaped head
toward the inner surface of the second member, and which receives
therein a threaded set screw such that, prior to insertion of the
set screw therein, the bore permits the ball-shaped head to
compress radially inwardly.
7. The device of claim 15, wherein the resilient element further
comprises a central opening which defines a curvate volume for
receiving and holding therein the ball-shaped head.
8. The device of claim 1, wherein the first and second members are
base plates.
9. The device of claim 1, wherein at least one of the first and
second members include a porous coating on an outer surface thereof
to facilitate bone in-growth.
10. The device of claim 1, wherein the first member at least
partially encloses the resilient element.
11. The device of claim 10, wherein the first member includes a
retaining wall extending therefrom, and wherein the retaining ring
is attached to and is at least partially enclosed by the retaining
wall.
12. The device of claim 1, wherein the retaining ring is attached
to the inner surface of the first plate member by a retaining
wall.
13. The device of claim 1, wherein the resilient element is movable
toward or away from the first member after the intervertebral
spacer device is fully assembled for insertion into the
intervertebral space.
14. The device of claim 1, wherein the resilient element is a
Belleville washer having a concave surface that contacts the first
member to hold the Belleville washer against the inner surface of
the first member.
15. The device of claim 5, wherein the post includes a ball-shaped
head.
16. The device of claim 6, wherein, after the insertion of the set
screw, the ball-shaped head is not readily radially
compressible.
17. The device of claim 1, wherein the resilient element is a
slotted washer.
18. An intervertebral spacer device for insertion into an
intervertebral space comprising: first and second plate members
disposed in a spaced apart relationship such that inner surfaces of
the first and second plate members oppose one another; a Belleville
washer coupled to the second member; and a retaining ring attached
to the first plate member to hold the Belleville washer against the
inner surface of the first plate member.
19. The device of claim 18, wherein the first plate member includes
a retaining wall extending therefrom, and wherein the retaining
ring is attached to and is enclosed by the retaining wall.
20. The device of claim 18, wherein the second plate member further
comprises a post to which the Belleville washer is articulably
coupled, the post extending from the inner surface thereof and
including a ball-shaped head.
21. The device of claim 20, wherein the post further includes a
threaded bore which extends axially from the ball-shaped head
toward the inner surface of the second member and which receives
therein a threaded set screw such that, prior to insertion of the
set screw therein, the bore permits the ball-shaped head to
compress radially inwardly.
22. The device of claim 20, wherein the Belleville washer further
comprises a central opening which defines a curvate volume for
receiving and holding therein the ball-shaped head.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application is a continuation application of U.S.
patent application Ser. No. 11/432,196, filed May 11, 2006, which
is a continuation application of U.S. patent application Ser. No.
10/783,292, filed Feb. 18, 2004, now U.S. Pat. No. 7,048,763, which
is a continuation application of U.S. patent application Ser. No.
09/968,047, filed Oct. 1, 2001, which is 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 belleville washer
having a radially varying thickness profile 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 which
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, determines 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
(L5) and the top of the sacrum (S1). Two cages 10 are generally
inserted side by side with the external threading 14 tapping into
the lower surface of the vertebral bone above (L5), and the upper
surface of the vertebral bone (S1) 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'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. 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.
[0008] It is further an object of the present invention to provide
an implant device which stabilizes the spine while still permitting
normal motion.
[0009] 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's spine.
[0010] 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
[0011] 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 limited rotation of the two plates relative to
one another. While there are a wide variety of embodiments
contemplated, two embodiments (and variations of both) are
described herein as representative of preferred types. Each of
these embodiments includes a spirally slotted and radially varying
thickness belleville washer utilized as its restoring force
providing element.
[0012] More particularly, with respect to the base plates, which
are similar in all embodiments, as the assembly is to be positioned
between the facing surfaces of adjacent vertebral bodies, and as
such need to 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 may each further include outwardly directed spikes which
penetrate the bone surface and mechanically hold the plates in
place. It is further anticipated that the plates could include a
porous coating into which the bone of the vertebral body can grow,
however, it is not a limitation which is required of embodiments of
the invention. (Note that this limited fusion of the bone to the
base plate does not extend across the intervertebral space.)
[0013] While not preferred, it is possible, that between the base
plates, on the exterior of the device, there may be 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 which 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 which are
compatible for use with this invention, the breadth of which shall
not be limited by the choice of such a material. Notwithstanding
the foregoing, such an exterior shroud and/or the interior
elastomeric materials which may be compatible with the present
invention, they are not preferred for use with the present
device.
[0014] As introduced above, the internal structure of the present
invention comprises a spring member, which provides a restoring
force when compressed. More particularly, the force restoring
member comprises at least one belleville washer. In the embodiments
described herein, the belleville washer has a radially varying
thickness. It is desirable that the restoring forces be directed
outward against the opposing plates, and for the restoring force
versus load profile to vary in a manner which approximates that of
the normal healthy intervertebral cartilage. In addition, it is
desirable that the restoring force providing subassembly not
substantially interfere with the rotation of the opposing plates
relative to one another, at least through a range of angles
equivalent to that permitted by normal healthy intervertebral
cartilage.
[0015] More particularly, the restoring force providing subassembly
comprises a belleville washer having a radially varying thickness.
Belleville washers are washers which are generally bowed in the
radial direction. Specifically, they have a radial convexity (i.e.,
the height of the washers 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 and the thickness 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 in the washer. In the present invention, there are
two separate embodiments each having two variations. The two
variations described herein relate to whether the washers include
spiral slots which initiate on the periphery of the washer and
extend along arcs which are generally radially inwardly directed a
distance toward the center of the bowed disc.
[0016] The first embodiment (which can exist in two variations,
i.e. slotted or unslotted) comprises a radially varying thickness
which is grows thicker as the radius increases (the thickness is
directly proportional to the radius). In the second embodiment
(also existing in the two embodiments which can be either slotted
or unslotted), the washers comprise a radially varying thickness
which is grows thinner as the radius increases (the thickness is
inversely proportional to the radius).
[0017] In both of these embodiments, superior reproduction of the
anatomical deflection to load characteristics is achieved. 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. The purpose of the present invention is to create a
non-linear load deflection profile by permitting a portion of the
washer to deflect early in the loading, and a more rigid portion to
deflect only under more severe loadings. By varying the thickness
of the washer material smoothly across it's radial extent, this
goal is achieved.
[0018] It is preferred that either embodiment be of the variation
in which the slots are provided inasmuch as the slots permit the
washer to expands and restores itself far more elastically than a
solid washer.
[0019] 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.
[0020] Referring now to the specific structure of the device, the
selected belleville washer 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, the invention comprises a pair of spaced apart base
plates, the first of which is simply a disc shaped member having
external and internal flat faces. This first plate further includes
a circular retaining wall for housing therein a selected belleville
washer and a retaining ring. The other of the plates is similarly
shaped, having a flat exterior surface, but includes a short
central post portion instead of the circular retaining wall. This
central post rises out of the interior face at a nearly
perpendicular angle. The top of this short 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.
[0021] As introduced above, radially modified thickness (and
potentially spirally slotted) belleville washer 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). 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.
BRIEF DESCRIPTION OF THE DRAWINGS
[0022] FIG. 1 is a side perspective view of an interbody fusion
device of the prior art.
[0023] 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.
[0024] FIGS. 3a and 3b are side cross-section views of the upper
and lower opposing plates of the present invention.
[0025] FIG. 4 shows a cross-sectional view of a belleville washer
with a thinner inner portion and a thicker outer portion.
[0026] FIG. 5 shows another cross-sectional view of a belleville
washer, in accordance with another preferred embodiment of the
present invention.
[0027] FIG. 6 shows a cross-sectional view of a belleville washer
with a thicker inner portion and a thinner outer portion, in
accordance with another preferred embodiment of the present
invention.
[0028] FIG. 7 shows a cross-sectional view of a belleville washer,
in accordance with another preferred embodiment of the present
invention.
[0029] FIGS. 8a, 8b, and 8c are top views of the opposing plates,
and more particularly, FIG. 8a is a top view of the plate having a
post element which seats within the central opening of the
belleville washer, FIG. 8b is a top view of the plate having the
circumferential skirt and a retaining ring, in which a belleville
washer of the type of FIGS. 4-7 is disposed within the skirt, and
FIG. 8c is a top view of the plate having the circumferential skirt
and a retaining ring, in which a belleville washer of the type of
FIGS. 4-7 is disposed within the skirt.
[0030] FIGS. 9, 10, 11, and 12 are side cross-section views of
various embodiments of the present invention which utilizes the
corresponding belleville washers illustrated in FIGS. 4-7 mounted
between the plates illustrated in FIGS. 3a and 3b.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0031] 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,
which scope shall be determined only by the claims appended hereto.
Like numbers refer to similar features of like elements
throughout.
[0032] Referring now to FIGS. 3a and 3b, side cross-section views
of the top and bottom plate members 100,200 of a first embodiment
of the present invention is shown. As the device is designed to be
positioned between the facing surfaces of adjacent vertebral
bodies, the plates include substantially flat surface 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
plates should 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.)
[0033] Referring now also to FIGS. 8a and 8b, plate 100 further
includes a circumferential skirt 106 which serves as a retaining
wall, into which the large end of a belleville washer (see FIGS.
4-7) may be seated. The diameter of the retaining wall 106 is
preferably slightly wider than the diameter of the undeflected
belleville washer such that the loading thereof can result in an
unrestrained radial deflection of the washer. The inner surface of
the retaining wall 106 includes an annular recess into which a
retaining ring may be provided for holding the belleville washer in
place (see the assembled FIGS. 9-12).
[0034] Referring now also to FIG. 8c, plate 200 further includes a
central post 206 which rises out of the interior face 208 at a
nearly perpendicular angle. The top of this short post member 206
includes a ball-shaped head 210. The head 210 includes a series of
slots 212 which render it compressible and expandable in
correspondence with a radial pressure (or a radial component of a
pressure applied thereto). There is a central threaded axial bore
214 which extends down the post 206. This threaded bore 214 is
designed to receive a small set screw 216. Prior to the insertion
of the set screw 216, the ball-shaped head 210 can deflect radially
inward (so that the ball-shaped head contracts) permitting the
belleville washer to be flexibly mounted thereon. The insertion of
the set screw 216 eliminates (or greatly reduces) the capacity for
this deflection.
[0035] Referring now to FIGS. 4-7, side cross-section views of four
separate embodiments of the belleville washers are provided. In
general, these belleville washers 130 comprise a domed circular
shape (a section of a sphere or three dimensional paraboloid would
be an appropriately corresponding shape), having a central opening
132 and an outer edge 134. 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. In the present invention,
the thickness (the distance from the concave surface to the convex
surface) of the material which comprises the washer varies from the
edge of the central opening 132 to the outer edge 134 of the
element.
[0036] More particularly with respect to the washer in FIG. 4 (and
shown within the circumferential ring of plate 100 in FIG. 8b), the
belleville washer 130a has a greater thickness at the outer edge
134a than at the edge of the central opening. As the restoring
force of a belleville washer is proportional to the elastic
properties of the material as well as the quantity of material
being loaded, the reduction of the material at the edge of the
central opening 132a permits a load/deflection profile in which the
load which deflects the inner portion of the washer is less than
the outer portion. This permits the washer to compress to initially
compress easily under a light loading, but to rapidly (faster than
a straight linear loading profile) become stiff and resist
deflection. This loading profile is more anatomically relevant with
respect to mimicking the performance of the cartilage present in a
healthy intervertebral space.
[0037] More particularly with respect to the washer in FIG. 5 (and
shown within the circumferential ring of plate 100 in FIG. 10), the
belleville washer 130b also has a greater thickness at the outer
edge 134b than at the edge of the central opening. However, the
washer further includes a series of spiral slots 138b extending
from the outer edge 134b toward the central opening 132b. The slots
138b extend from the outer diameter of the belleville washer,
inward along arcs generally directed toward the central opening
132b of the element. The slots 138b do not extend fully to the
center of the device. 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. As the
restoring force of a belleville washer is proportional to both the
geometry of the material being loaded and its elastic properties,
the varying thickness combined with the radial slots 138b permits a
load/deflection profile in which the load which deflects the inner
portion of the washer is less than the outer portion. This permits
the washer to compress to initially compress easily under a light
loading, but to rapidly (faster than a straight linear loading
profile) become stiff and resist deflection. This loading profile
is more anatomically relevant with respect to mimicking the
performance of the cartilage present in a healthy intervertebral
space.
[0038] More particularly with respect to the washer in FIG. 6 (and
shown within the circumferential ring of plate 100 in FIG. 11), the
belleville washer 130c has a smaller thickness at the outer edge
134c than it is at the inner edge 132c. As the restoring force of a
belleville washer is proportional to the elastic properties of the
material as well as the quantity of material being loaded, the
reduction of the material at the outer edge 134c permits a load
profile in which the load which deflects the outer portion of the
washer is less than the inner portion. This permits the washer to
compress to initially compress easily under a light loading (as a
result of outer edge deflection), but to rapidly (faster than a
straight linear loading profile) become stiff and resist
deflection. This loading profile is more anatomically relevant with
respect to mimicking the performance of the cartilage present in a
healthy intervertebral space.
[0039] More particularly with respect to the washer in FIG. 7 (and
shown within the circumferential ring of plate 100 in FIG. 12), the
belleville washer 130d has a smaller thickness at the outer edge
134d than at the edge of the central opening. However, the washer
further includes a series of spiral slots 138d extending from the
outer edge 134d toward the central opening. The slots 138d extend
from the outer diameter of the belleville washer, inward along arcs
generally directed toward the central opening of the element. The
slots 138d do not extend fully to the center of the device. 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. As the restoring force of a belleville
washer is proportional to both the geometry of the material being
loaded and its elastic properties, the varying thickness combined
with the radial slots 138d permits a load/deflection profile in
which the load which deflects the inner portion of the washer is
less than the outer portion. This permits the washer to compress to
initially compress easily under a light loading, but to rapidly
(faster than a straight linear loading profile) become stiff and
resist deflection. This loading profile is more anatomically
relevant with respect to mimicking the performance of the cartilage
present in a healthy intervertebral space.
[0040] In addition, the central openings of each of the belleville
washer embodiments described hereinabove further includes a curvate
volume for receiving therein the ball-shaped head 210 of the post
206 of the lower plate 200 described above.
[0041] Referring now to FIGS. 9-12, side cross-sectional views of
the fully assembled embodiments of the intervertebral spacers which
comprise the present invention are provided. Each structure
includes the belleville washer (selected from the corresponding
ones illustrated in FIGS. 4-7). Each further includes the following
common features: two opposing plates 100,200 having their flat
surfaces 102,202, respectively, directed away from one another (to
be seated against the adjacent bone); a retaining ring 110 is
seated in the annular groove of the retaining wall 106; and a
ball-shaped-headed central post 206 extending into the central
opening 132 of the corresponding belleville washer 130, rotatably
secured in place by set screw 216. The deflectability of the
ball-shaped head of the post 206, prior to the insertion of the set
screw 216, permits the head to be inserted into the interior volume
at the center of the belleville washer 130. Subsequent introduction
of the set screw 216 into the axial bore of the post 206 prevents
the ball-shaped head from deflecting. Thereby, the washer 130 can
be secured to the ball-shaped head so that it can rotate thereon
through a range of proper lordotic angles. While not in this
preferred embodiment, it should be noted that in other embodiments,
a tightening of the set screw can lock the washer 130 on the
ball-shaped head at one of the lordotic angles.
[0042] While there has been described and illustrated 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 present invention shall, therefore, be not
be limited by the specific embodiments provided herein solely as
representative examples of such invention.
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