U.S. patent application number 11/399903 was filed with the patent office on 2007-05-03 for method and apparatus for fixation of intervertebral disc prosthesis.
This patent application is currently assigned to DePuy Spine, Inc.. Invention is credited to Matthew Parsons.
Application Number | 20070100455 11/399903 |
Document ID | / |
Family ID | 37997533 |
Filed Date | 2007-05-03 |
United States Patent
Application |
20070100455 |
Kind Code |
A1 |
Parsons; Matthew |
May 3, 2007 |
Method and apparatus for fixation of intervertebral disc
prosthesis
Abstract
An intervertebral disc prosthesis comprises a superior endplate
and an inferior endplate. The superior and inferior endplates
include vertebra fixation surfaces designed to engage vertebral
bodies. A composite material is provided on the vertebra fixation
surfaces. The composite material includes an osteoconductive
component and an osteoinductive component. The osteoconductive
component provides a porous matrix or base that facilitates bone
growth. The osteoinductive component provides a stimulant material
that encourages growth of the bone cells between the
osteoconductive component of the endplate and the vertebral body
facing the endplate. In one embodiment, the osteoconductive
component is permeated by an osteoinductive material to provide the
composite material. In another embodiment, the composite material
includes a non-resorbable portion that includes osteoconductive
substances and a resorbable portion that is doped with
osteoinductive substances.
Inventors: |
Parsons; Matthew;
(Dartmouth, MA) |
Correspondence
Address: |
MAGINOT, MOORE & BECK, LLP;CHASE TOWER
111 MONUMENT CIRCLE
SUITE 3250
INDIANAPOLIS
IN
46204
US
|
Assignee: |
DePuy Spine, Inc.
Raynham
MA
|
Family ID: |
37997533 |
Appl. No.: |
11/399903 |
Filed: |
April 7, 2006 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
11264471 |
Oct 31, 2005 |
|
|
|
11399903 |
Apr 7, 2006 |
|
|
|
Current U.S.
Class: |
623/17.14 ;
623/23.51 |
Current CPC
Class: |
A61F 2002/30522
20130101; A61F 2/4611 20130101; A61F 2002/30841 20130101; A61F
2310/00029 20130101; A61F 2002/305 20130101; A61F 2002/30179
20130101; A61F 2002/30616 20130101; A61F 2002/30649 20130101; A61F
2002/30451 20130101; A61F 2002/30772 20130101; A61F 2310/00976
20130101; A61F 2002/30604 20130101; A61F 2002/4627 20130101; A61F
2250/0019 20130101; A61F 2002/30843 20130101; A61F 2/30771
20130101; A61F 2002/30574 20130101; A61F 2002/30894 20130101; A61F
2/4425 20130101; A61F 2230/0028 20130101; A61F 2310/00179 20130101;
A61F 2002/30448 20130101; A61F 2220/0025 20130101; A61F 2220/0033
20130101; A61F 2002/30662 20130101; A61F 2002/3082 20130101; A61F
2250/0098 20130101; A61F 2310/00023 20130101; A61F 2310/00796
20130101; A61B 2017/0256 20130101; A61F 2002/4628 20130101; A61F
2002/30331 20130101; A61F 2220/0058 20130101; A61F 2002/3008
20130101; A61F 2002/30112 20130101; A61F 2220/005 20130101; A61F
2002/30016 20130101; A61F 2002/30064 20130101; A61F 2230/0004
20130101; A61F 2002/443 20130101 |
Class at
Publication: |
623/017.14 ;
623/023.51 |
International
Class: |
A61F 2/44 20060101
A61F002/44; A61F 2/28 20060101 A61F002/28 |
Claims
1. An intervertebral disc prosthesis comprising: a) a first
endplate including a first vertebra fixation surface; b) a second
endplate including a second vertebra fixation surface, wherein the
first endplate is operable to pivot relative to the second
endplate; and c) a composite material provided on the first
vertebra fixation surface, the composite material comprising an
osteoconductive material and an osteoinductive material.
2. The intervertebral disc prosthesis of claim 1 wherein the
osteoconductive material is permeated with the osteoinductive
material.
3. The intervertebral disc prosthesis of claim 1 wherein the
composite material includes a resorbable portion doped with the
osteoinductive material and a non-resorbable portion comprising the
osteoconductive material.
4. The intervertebral disc prosthesis of claim 3 wherein the
resorbable portion comprises a resorbable carrier selected from the
group consisting of calcium phosphate, hydroxyapatite, collagen,
biodegradable polyglycolic acid, polylactic acid or a hydrogel.
5. The intervertebral disc prosthesis of claim 1 wherein the
osteoconductive material is selected from the group consisting of
titanium, metal matrix composite, ceramic, calcium phosphate,
hydroxyapatite or a matrix of cross-linked collagen fibers coated
with hydroxyapatite.
6. The intervertebral disc prosthesis of claim 1 wherein the
osteoinductive material is selected from the group consisting of
bone morphogenetic protein, bone marrow or stem cells.
7. A method of fixing an intervertebral disc prosthesis in an
intervertebral space, the method comprising: a) providing an
intervertebral disc prosthesis including at least one vertebra
fixation surface; and b) applying a composite material to the
vertebra fixation surface, the composite material comprising an
osteoconductive component and an osteoinductive component.
8. The method of claim 7 further comprising the step of inserting
the intervertebral disc prosthesis in an intervertebral space with
the vertebra fixation surface in contact with a vertebral body.
9. The method of claim 7 wherein the at least one vertebra fixation
surface includes a first vertebra fixation surface and a second
vertebra fixation surface, wherein the first vertebra fixation
surface is operable to pivot relative to the second vertebra
fixation surface.
10. The method of claim 7 wherein the osteoconductive component
comprises a first material and the osteoinductive component
comprises a second material, and wherein the first material is
permeated with the second material.
11. The method of claim 10 further comprising the step of soaking
the first material in the second material in order to permeate the
first material with the second material.
12. The method of claim 7 wherein the vertebra fixation surface
comprises a textured surface.
13. The method of claim 12 wherein the step of applying the
composite material to the vertebra fixation surface comprises the
step of packing the composite material on the textured surface.
14. The intervertebral disc prosthesis of claim 7 wherein the
osteoinductive component includes a resorbable portion and the
osteoconductive component includes a non-resorbable portion.
15. The intervertebral disc prosthesis of claim 14 wherein the
resorbable portion is doped with an osteoinductive material, and
the osteoinductive material includes bone morphogenetic protein or
bone marrow.
16. An intervertebral disc prosthesis comprising: a) a first
vertebra fixation surface; and b) a composite material provided on
the first vertebra fixation surface, the composite material
comprising an osteoconductive material and an osteoinductive
material.
17. The intervertebral disc prosthesis of claim 16 further
comprising a second vertebra fixation surface, wherein the first
vertebra fixation surface is operable to pivot relative to the
second vertebra fixation surface.
18. The intervertebral disc prosthesis of claim 17 further
comprising a bearing surface positioned between the first vertebra
fixation surface and the second vertebra fixation surface, wherein
the first vertebra fixation surface is operable to pivot upon the
bearing surface.
19. The intervertebral disc prosthesis of claim 16 wherein the
osteoconductive material is permeated with the osteoinductive
material.
20. The intervertebral disc prosthesis of claim 19 wherein the
first vertebra fixation surface comprises a textured surface, and
the composite material is applied to the textured surface.
21. The intervertebral disc prosthesis of claim 16 wherein the
composite material includes a resorbable portion and a
non-resorbable portion.
22. The intervertebral disc prosthesis of claim 21 wherein the
resorbable portion is doped with the osteoinductive material and
the non-resorbable portion comprises the osteoconductive
material.
23. The intervertebral disc prosthesis of claim 16 further
comprising an endplate including a face, wherein the first vertebra
fixation surface is provided on the face of the endplate.
24. The intervertebral disc prosthesis of claim 23 wherein at least
one tooth is included on the face of the endplate and the first
vertebra fixation surface is provided on the at least one tooth.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation-in-part of U.S. patent
application Ser. No. 11/264,471 filed Oct. 31, 2005.
BACKGROUND
[0002] This invention relates to the field of prosthetics, and more
particularly, to an intervertebral disc prosthesis designed to
replace a damaged intervertebral disc.
[0003] The human spine consists of twenty-four small bones known as
vertebrae, or "vertebral bodies," that protect the spinal cord and
provide stability to the torso. The vertebrae are arranged in a
column and stacked vertically upon each other. Between each
vertebra is a fibrous bundle of tissue called an intervertebral
disc. These intervertebral discs act as a cushion to the spinal
column by absorbing energy and transmitting loads associated with
everyday movement. They also prevent the vertebrae from rubbing
against each other.
[0004] Each intervertebral disc comprises two distinct regions. A
firm outer region, the annulus, maintains the shape of the
intervertebral disc. An inner region, the nucleus, provides a
resilient tissue that enables the disc to function as a shock
absorber. Over time, the normal aging process causes the
intervertebral discs to degenerate, diminising their water content
and thereby reducing their ability to properly absorb the impact
associated with spinal movements. Diminished water content in the
intervertebral discs may also cause the vertebrae to move closer
together. Tears and scar tissue can weaken the discs, resulting in
injury. When the discs wear out or are otherwise injured, a
condition known as degenerative disc disease results. With this
condition, discs do not function normally and may cause pain and
limit activity.
[0005] The condition of degenerative disc disease can potentially
be relieved by a surgical procedure called artificial disc
replacement. In this procedure, the damaged intervertebral disc is
replaced by a prosthetic disc. One well known intervertebral
prosthetic disc is produced by DePuy Spine, Inc. of Raynaham, Mass.
and is sold under the trademark CHARITE.RTM.. This disc prosthesis
is comprised of two metal endplates and a center polyethylene core.
The center core includes a superior spherical bearing surface and
an inferior spherical bearing surface. The superior endplate
includes a concave surface that fits upon and is congruent with the
superior bearing surface of the core. The inferior endplate
includes a concave surface that fits under and is congruent with
the inferior bearing surface of the core. During the CHARITE.RTM.
artificial disc replacement procedure, the damaged disc is first
removed via an anterior surgical approach and the end surfaces of
the exposed vertebrae are cleared of debris. The vertebrae are
spread apart and the metal endplates are positioned on the
respective vertebra and tapped into place. The polyethylene core is
then inserted between the endplates and the vertebrae are returned
to their normal position. The pressure of the spinal column further
seats the endplates into the vertebral bones and secures the core
in place.
[0006] Although current intervertebral disc prosthetic devices have
enjoyed success, it would be beneficial to add additional desirable
features to the prosthetic device. For example, it would be
desirable to design the prosthetic device to provide improved
fixation features to ensure attachment of the prosthetic device to
the vertebral bodies. It would be particularly advantageous if such
fixation features facilitated bony in-growth between the prosthetic
device and the vertebral bodies, thus providing a secure and
natural fixation of the prosthetic device to the vertebral
bodies.
SUMMARY
[0007] An intervertebral disc prosthesis comprises a superior
endplate and an inferior endplate. A bearing surface is positioned
between the superior endplate and the inferior endplate such that
the superior endplate is operable to pivot relative to the inferior
endplate. The superior and inferior endplates include vertebra
fixation surfaces designed to engage the vertebral bodies. The
vertebra fixation surfaces are typically included on the faces of
the endplates. For example, the vertebra fixation surfaces may be
provided on a plurality of teeth found on the faces of the
endplates.
[0008] A textured surface is formed on each vertebra fixation
surface. The textured surface provides a substrate that will
accommodate bony in-growth between the endplate and the vertebral
body. The surface texture on the teeth or other endplate surfaces
may take any of several forms. In one embodiment, the texture is
provided by an osteoconductive coating. The textured surface may
also be provided by mechanical processes such as grinding or
engraving, energy beam processes such as laser beam or electron
beam, lithographical processes such as chemical lithography or
electrochemical lithography, or other processes known in the art.
The textured surface may be patterned or random and may include
pockets, slots, grooves, indentations, bumps, or other
texturing.
[0009] The textured surface to provides a substrate for bone growth
and attachment. An osteoinductive material is incorporated into or
applied onto the substrate or the osteoconductive material to
promote accumulation, attachment, and in-growth of the bone cells.
Bony in-growth will result in a secure attachment between the
endplate and the vertebral body.
[0010] Provision of the textured surface may also be included as a
composite material applied to the fixation surface of the endplate,
wherein the composite material includes an osteoconductive
component and an osteoinductive component. The osteoconductive
component provides a porous matrix or base that facilitates bone
attachment. The osteoinductive component provides a stimulant
material that encourages growth of the bone cells between the
osteoconductive component of the endplate and the vertebral body
facing the endplate.
[0011] In one embodiment, the osteoconductive component is soaked
in or otherwise permeated by an osteoinductive material to provide
the composite material. In another embodiment, the composite
material includes a non-resorbable portion that includes
osteoconductive substances and a resorbable portion that is doped
with osteoinductive substances. The resorbable portion of the
composite material is subject to dissolution in the body and
essentially serves as a carrier designed to deliver a timed release
of osteoinductive substances. As the resorbable component breaks
down in the body, the osteoinductive substance is released and
promotes bony ingrowth/attachment to the non-resorbable portion of
the coating.
DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1 shows an superior perspective view of an
intervertebral disc prosthesis including a superior plate and a
inferior plate separated by a core;
[0013] FIG. 2 shows a side cross-sectional view of the
intervertebral disc prosthesis of FIG. 1;
[0014] FIG. 3 shows a side cross-sectional view of the
intervertebral disc prostheis of FIG. 1 with the superior plate
rotated to display flexion;
[0015] FIG. 4 shows a perspective view of an alternative embodiment
of the intervebral disc prosthesis of FIG. 1;
[0016] FIG. 5 shows a top plan view of the intervertebral disc
prosthesis of FIG. 4 including a top plan view of a superior plate
of the intervertebral disc prosthesis;
[0017] FIG. 6 shows a bottom plan view of the superior plate of the
intervertebral disc prosthesis of FIG. 5, showing an articulation
socket;
[0018] FIG. 7 shows a right side elevational view of the superior
plate of the intervebral disc prosthesis of FIG. 5;
[0019] FIG. 8 shows a cross-sectional view of the intervertebral
disc prosthesis through line X-X of FIG. 5;
[0020] FIG. 9 shows a cross-sectional view of the intervertebral
disc prosthesis through line XI-XI of FIG. 5;
[0021] FIG. 9A shows a cross-sectional view of an alternative
embodiment of the intervebral disc prosthesis of FIG. 9;
[0022] FIG. 10 shows a bottom plan view of the superior plate of
FIG. 6 and its footprint in relation to a vertebral body;
[0023] FIG. 11 shows a perspective view of an alternative
embodiment of an endplate of the intervertebral disc prosthesis of
FIG. 4;
[0024] FIG. 11A shows a perspective view of another alternative
embodiment of the endplate of FIG. 11 including a coating on the
face of the endplate;
[0025] FIG. 12 shows a perspective view of an alternative
embodiment of the bottom surface of an endplate of the
intervertebral disc prosthesis of FIG. 4;
[0026] FIG. 12A shows a perspective view of an alternative
embodiment of the intervertebral disc prosthesis of FIG. 4
including additional insertion features;
[0027] FIG. 13 shows a perspective view of an alternative
embodiment of the intervertebral disc prosthesis of FIG. 4;
[0028] FIG. 14A shows a cross-sectional view of an alternative
embodiment of the intervertebral disc prosthesis of FIG. 4 having a
core with an extended flange configured to limit motion;
[0029] FIG. 14B shows a cross-sectional view of an alternative
embodiment of the intervertebral disc prosthesis of FIG. 14A;
[0030] FIG. 15 shows a top view of an alternative embodiment of a
core of the intervertebral disc prosthesis of FIG. 4;
[0031] FIG. 15A shows a cross-sectional view of the core of FIG. 15
through line A-A;
[0032] FIG. 16 shows a top view of another alternative embodiment
of a core of the intervertebral disc prosthesis of FIG. 4;
[0033] FIG. 16A shows a cross-sectional view of the core of FIG. 16
through line A-A;
[0034] FIG. 17 shows a top view of yet another alternative
embodiment of a core of the intervertebral disc prosthesis of FIG.
4;
[0035] FIG. 17A shows a cross-sectional view of the core of FIG. 17
through line A-A;
[0036] FIG. 17B shows a cross-sectional view of the core of FIG. 17
through line B-B;
[0037] FIG. 18 shows a perspective view of an disc insertion tool
for the intervertebral disc prosthesis of FIG. 4 in a retracted
position;
[0038] FIG. 19 shows a perspective view of the disc insertion tool
of FIG. 18 inserting the intervertebral disc prosthesis between
vertebral bodies;
[0039] FIG. 20 shows a perspective view of the disc insertion tool
of FIG. 18 in an extended position;
[0040] FIG. 21 shows a top view of the intervertebral disc
prosthesis of FIG. 12A engaged with a disc insertion tool; and
[0041] FIG. 22 shows a perspective view of the disc insertion tool
of FIG. 21.
DESCRIPTION
General Structure
[0042] With reference to FIGS. 1-3, an intervertebral disc
prosthesis 30 comprises a superior plate 32, an inferior plate 34,
and a core 36. The core 36 is sandwiched between the superior plate
32 and the inferior plate 34. The superior plate 32 and the
inferior plate 34 ride upon the core 36 and are operable to rotate
relative to the core.
[0043] The superior plate 32 serves as a first endplate for the
prosthetic device 30. In one embodiment, the superior plate 32 is
comprised of metal. In particular, the superior plate 32 may be
comprised of a medical grade cobalt chromium alloy. The superior
plate 32 comprises an upper surface 40 on one side and a lower
surface 42 on the other side. An outer perimeter edge 44 defines
the "footprint" shape of the superior plate 32.
[0044] The upper surface 40 of the superior plate 32 is designed
for engagement with a vertebral surface of a patient. To this end,
the upper surface 40 of the superior plate may be slightly convex
for close engagement with the slightly concave vertebral surface of
the patient. A typical convexity of the superior plate is based on
a 90-200 mm radius of curvature. The preferred convexity will vary
from patient to patient, depending upon the size and vertebral
surface shape of the patient.
[0045] Teeth 46 are included on the upper surface 40 of the
superior plate 32. The teeth 46 are designed to penetrate into the
vertebral surface, helping to secure the superior plate 32 to the
vertebral surface. As explained in further detail below, certain
advantages are achieved based on the positioning of the teeth on
the plate 32, the size of the teeth 46, and the shape of the teeth.
Screws (not shown) may also be threaded through holes (not shown)
in the superior plate to provide further assistance in securing the
superior plate 32 to the vertebral surface.
[0046] The inferior surface 42 of the superior plate 32 is
generally flat near the outer perimeter edge 44. However, with
reference to FIGS. 2-3, a donut-shaped collar portion 48 depends
from the center of the inferior surface 42 of the plate 32. An
inner concave surface 49 is provided at the center of the collar
portion 48. As explained in further detail below, this inner
concave surface 49 serves as a bearing surface/articulating surface
for engagement with the core. As explained in further detail below,
the bearing surfaces of the endplates and core together provide
ball and socket joint arrangements for the prosthetic device.
[0047] The inferior plate 34 is a mirror image of the superior
plate 32 and is also made of a medical grade cobalt chromium alloy.
The inferior plate 34 includes a slightly convex inferior surface
50 outlined by an outer perimeter edge 54. A plurality of teeth 56
extend from the inferior surface 50. The teeth 56 are designed to
help secure the inferior plate 34 to a vertebral surface. The upper
surface 52 of the inferior plate 34 includes a collar portion 58
with an inner concave surface 59 which provides a bearing
surface/articulating surface for engagement with the core.
[0048] The prosthesis core 36 is sandwiched between the superior
plate 32 and the inferior plate 34. The core 36 is arranged within
an interior space of the prosthesis 30 defined between the lower
surface 42 of the superior plate 32 and the upper surface 52 of the
inferior plate 34. In one embodiment, the prosthesis core 36 is
comprised of a plastic material having a high resistance to wear,
such as ultra high molecular weight polyethylene (UHMWPE), which
allows the endplates 32 and 34 to slide easily on the core. The
prosthesis core 36 is generally disc shaped with an outer radial
flange 60, an upper spherical surface 62, and a lower spherical
surface 64. The upper spherical surface and lower spherical surface
act as bearing surfaces/articulating surfaces that engage the
bearing surfaces of the endplates 32 and 34. As shown in FIG. 2, a
first groove 66 is formed between the flange 60 and the superior
spherical surface 62. A second groove 68 is formed between the
flange 60 and the inferior spherical surface 64.
[0049] When the prosthesis 30 is assembled, the concave surface 49
of the superior plate 32 and the upper spherical surface 62 of the
core 36 engage one another and form articular surfaces. Likewise,
the concave surface 59 of the inferior plate 34 and the lower
spherical surface 64 of the core 36 engage one another and form
articular surfaces.
[0050] In one preferred embodiment, the articular surfaces 49, 62,
59, 64 are substantially spherical and remain congruous during
torsional rotation around the vertical axis 70. In this embodiment,
the radii of the arcs in the frontal plane (i.e., the lateral
bending plane) are equal to the radii of the arcs in the sagittal
plane (i.e., flexion plane). This allows the plates 32 and 34 to
rotate upon the core 36, including rotation in the transversal
plane (i.e., torsional plane) while the articular surfaces remain
in congruous contact. In this embodiment, the articular surfaces
49, 62, 59, 64 do not offer significant resistance to torsional
rotation.
[0051] With reference to FIG. 3, the radial flange 60 and
associated grooves 66 and 68 provide for limited movement of the
endplates in the frontal (lateral bending) plane and sagittal
(flexion/extension) plane. In particular, at a certain angle of
rotation of the superior plate 32 relative to the inferior plate 34
in the frontal and sagittal planes, the flange 60 of the prosthesis
core engages the collar portions 48 and 58 of the endplates 32, 34.
This provides a defined stop against excessive rotation in the
frontal (lateral bending) plane and sagittal (flexion/extension)
plane of the prosthesis 30.
Further Embodiments
[0052] With reference to FIG. 4, an alternative embodiment of an
intervertebral disc prosthesis 130 is shown. As shown in FIG. 4,
the prosthesis 130 comprises a superior plate 132, an inferior
plate 134 and a core 136 sandwiched between the superior plate 132
and the inferior plate 134. The superior plate 132 is generally
symmetric to the inferior plate 134. The plates are configured to
include an anterior side 180, a posterior side 182, a left side
184, and a right side 186.
[0053] The "footprint" of each endplate 132 and 134 is designed to
provide a more anatomically representative endplate shape that
generally conforms to the vertebral endplate anatomy, as shown in
FIG. 10. With reference to FIGS. 5, 6 and 10, the left side 184 of
the superior endplate 132 is generally straight/flat and parallel
to the right side 186 of the plate 132. The anterior side 180 of
the endplate 132 is generally arched and provides a curved edge
that extends from the left side 184 to the right side 186 of the
endplate 132. The anterior edge 180 of the endplate 132 provides an
arch defined by a radius of curvature ranging from 10 to 40 mm.
[0054] The posterior side 182 of the endplate includes three angled
edges that give the endplate a trapezoidal appearance. In
particular, the posterior side 182 of the endplate 132 includes a
rear edge 178, a left bevel 174, and a right bevel 176. The left
bevel 174 joins the rear edge 178 to the left edge 184 and the
right bevel 176 joins the rear edge 178 to the right edge 186. The
left bevel 174 is substantially straight and extends between the
rear edge 178 and the left edge 184 at a 45.degree. angle relative
to the rear edge. Likewise, the right bevel 176 is substantially
straight and extends between the rear edge 178 and the right edge
178 at a 45.degree. angle relative to the rear edge. The rear edge
178 is generally perpendicular to the right edge 186 and left edge
184.
[0055] As shown in FIG. 10, the above-described endplate footprint
allows the endplate to substantially conform to the vertebral body
200 of the patient. In particular, the endplate footprint covers a
substantial portion of the vertebral body, thus providing
additional surface area for connection and bony in-growth between
the endplate and the vertebral body. This in-growth may be
facilitated by a porous bony in-growth coating on the
endplates.
[0056] In addition to the above, each endplate 132 and 134 of the
prosthesis 130 is slightly convex for close engagement with the
slightly concave vertebral surface of the patient. A typical
convexity of the superior plate is based on a 90-200 mm radius of
curvature. The preferred convexity will vary from patient to
patient, depending upon the patient's size and vertebral surface
shape.
Endplate Teeth and Fixation Features
[0057] As shown in FIGS. 4 and 5, the teeth 146 of the endplates
132 and 134 are generally pyramidal in shape with a triangular base
positioned on the outer surface 140 of the endplate (i.e., the
upper surface of the superior endplate). The triangular base is an
acute triangle with two of the triangular sides significantly
longer than the triangular side opposite the vertex 190 of the
triangular base. This results in pyramidal shaped teeth having two
elongated faces 192, 194. The teeth are arranged radially upon the
endplates 132 and 134 with the vertex 190 of each triangular base
pointed toward a central portion of the endplate. The teeth 146 are
also generally positioned toward the left side 184 and right side
186 of the endplates. The radial arrangement of the teeth 146 on
the left and right sides of the endplate results in the elongated
faces 192 and 194 of the teeth directed generally toward the
anterior or posterior sides of the endplates (i.e.,
anterior-posterior faces).
[0058] Each pyramidal shaped tooth 146 may be further defined by a
width and a height. The width of the tooth 146 is generally defined
as the distance between the vertex 190 of the triangular base and
the opposing side of the triangular base on the surface of the
endplate. The height of the tooth is generally defined as the
perpendicular distance from the pyramidal vertex 196 of the tooth
146 to the face of the endplate. The teeth shown in FIGS. 4 and 5
are broad teeth having a width that is greater than their height.
This generally short yet broad tooth structure allows the
prosthesis 130 to be more easily inserted into the intervertebral
space than those prosthetic devices with longer teeth. This tooth
structure also results in broad antero-posterior faces. The broad
antero-posterior faces provide significant resistance to migration
and antero-posterior shear/expulsion once the prosthetic device is
in place in the intervertebral space. The radial arrangement of the
teeth provides resistance to lateral shear and rotation relative to
the vertebral bodies.
[0059] Another alternative embodiment of the teeth is shown in FIG.
13. The teeth of FIG. 13 include two elongated radial teeth 246 and
two elongated circumferential teeth 248. The radial teeth are wedge
shaped and extend laterally from right to left near the lateral
midline of the prosthesis. Each radial tooth includes an elongated
anterior face 250 and an elongated posterior face (not shown). The
circumferential teeth 248 bisect the radial teeth 246 as they
extend circumferentially upon the face of the endplate. The
circumferential teeth 248 are also wedge shaped. Each
circumferential tooth 248 includes an exterior face 254 and an
interior face 256. Together, the radial teeth 246 and
circumferential teeth 248 form cross-shaped teeth on the left side
and the right side of each endplate face. The teeth are relatively
short and broad, allowing the intervertebral prosthesis to be more
easily inserted in the intervertebral space. In addition, the
cross-shaped tooth arrangement is configured to provide significant
resistance to migration of the endplates once the intervertebral
prosthesis is positioned in a patient.
[0060] In addition to the above features, the teeth may include a
textured surface that will accommodate bony in-growth between the
endplate and the vertebral body. However, the use of a textured
surface on the endplate is not limited to the teeth. Textured
surfaces may be provided on other portions of the endplate where
bony in-growth is desirable. For example, as shown in FIG. 11A, the
face 140 of the endplate 132 includes a textured portion 147
designed to contact a vertebra.
[0061] The surface texture on the teeth or other endplate surfaces
may take any of several forms. In one embodiment, the texture is
provided by a coating of titanium, hydroxyapatite (HA), calcium
phosphate, an osteoconductive matrix of cross-linked collagen
fibers coated with hydroxyapatite (such as that sold under the
trademark Healos.RTM.), or other osteoconductive materials as are
known in the art. Such osteoconductive materials and/or coatings
generally provide a porous substrate capable of accommodating bone
growth and attachment. Osteoconductive coatings may be applied by a
physical packing, brush, spray, chemical vapor deposition, physical
vapor deposition, electrochemical deposition, or other methods as
are known in the art. Alternatively, the textured surface may be
provided by mechanical processes such as grinding or engraving,
energy beam processes such as laser beam or electron beam,
lithographical processes such as chemical lithography or
electrochemical lithography, or other processes known in the art.
The textured surface may be patterned or random and may include
pockets, slots, grooves, indentations, bumps, or other texturing.
As used herein, the term "textured surface" generally refers to a
surface where texturing is intentionally formed on a surface using
an osteoconductive coating, mechanical process, lithographical
process, energy beam process, or other process. However, the term
"textured surface" as used herein does not refer to the microscopic
texture inherent to a surface that is not otherwise intentionally
formed on the surface.
[0062] The faces 192 and 194 of the teeth generally provide a good
surface area where a textured surface capable of accommodating bone
growth may be formed. However, as mentioned above, other surfaces
on the endplate are also appropriate for a textured surface, such
as textured portion 147 on the endplate 132 of FIG. 11A.
[0063] Bony in-growth will result in a secure attachment between
the endplate and the vertebral body. Bone morphogenetic protein
(BMP), bone marrow, stem cells or other osteoinductive material is
used as the stimulant to promote bony in-growth. The osteoinductive
material can be incorporated into or applied onto the endplate or
the osteoconductive material. This combination of an osteoinductive
material in association with an osteoconductive material on the
surface of the endplate provides a desirable setting for bony
in-growth. In one embodiment, an osteoconductive coating is
provided as a first coating on the vertebra fixation surface of the
endplate. An osteoinductive material is then applied as a second
coating over the first coating of osteoconductive material. The
osteoinductive material provides a stimulant material that
encourages growth of the bone cells between the osteoconductive
coating of the endplate and the vertebral body facing the
endplate.
[0064] In another embodiment, a coating of a composite material is
applied to the vertebra fixation surface, wherein the composite
material includes an osteoconductive component incorporated with an
osteoinductive component. For example, a composite material
including an osteoconductive component and an osteoinductive
component may be provided by Healos.RTM. soaked in or otherwise
permeated with BMP or bone marrow. In this example, the Healos.RTM.
provides the osteoconductive material/component and the BMP or bone
marrow provides the osteoinductive material/component. The
Healos.RTM. is soaked in the BMP or bone marrow before application
to the vertebra fixation surface of the endplate. After the
Healos.RTM. is soaked in BMP (or bone marrow) the soaked material
may be cut to a desired size and/or configuration for proper
placement on the vertebra fixation surface. The soaked Healos.RTM.
is then packed in a textured surface formed on the endplate, such
as pockets or grooves on the anterior/posterior faces of the teeth
or other vertebra fixation surface. While this embodiment has been
described with reference to Healos.RTM. soaked in BMP or bone
marrow, it should be recognized that other osteoconductive
materials may soaked with the same or different osteoinductive
materials to prepare the material to be packed on the vertebra
fixation surface. In addition, it should be recognized that the
osteoconductive material could actually be packed on the endplate
before the osteoconductive material is soaked in the osteoinductive
material.
[0065] In addition to the above, other coatings of composite
materials having osteoinductive and osteoconductive properties may
be provided. For example, in one embodiment the composite material
includes a non-resorbable portion that includes osteoconductive
substances and a resorbable carrier portion that is doped with
osteoinductive substances. The resorbable portion of the composite
material is subject to dissolution in the body and essentially
serves as a carrier designed to deliver a timed release of
osteoinductive substances.
[0066] Examples of materials that may be used as the non-resorbable
portion of such composite material include titanium, metal matrix
composite (MMC), ceramic or combinations thereof. Such
osteoconductive substances serve as a porous matrix or base to
which the resorbable carrier adheres. Examples of materials that
may be used as the resorbable carrier portion include calcium
phosphate, hydroxyapatite, collagen, mineralized collagen,
biodegradable polyglycolic acid (PGA), polylactic acid (PLA),
hydrogels, or combinations thereof. As mentioned above, the
resorbable carrier portion is doped or impregnated with an
osteoinductive substance, such as BMP, the patient's bone marrow,
stem cell concentrates, or combinations thereof. As the resorbable
component breaks down in the body, the osteoinductive substance
impregnated in the resorbable component is released, promoting bony
ingrowth and attachment to the non-resorble portion of the
coating.
Posterior Center of Rotation
[0067] FIG. 6 shows a plan view of the lower surface 142 of the
superior plate 132 of one embodiment of the intervertebral disc
prosthesis 130. As shown in FIG. 6, a donut-shaped collar portion
148 is included on the lower surface 142 of the upper plate 132.
The collar 148 extends outward from other portions of the lower
surface 142 and surrounds a semi-spherical concave surface 149 that
provides a socket for the core 136 of the prosthesis. The concave
surface 149 defines a center-of-rotation for the superior plate 132
relative to the core 136. The position of the center of rotation is
shown in FIG. 6 by a "+" 120. Also shown in FIG. 6 is a lateral
midline 122 extending laterally across the plate 132 from the left
side 184 to the right side 186. The lateral midline 122 is a line
located directly between the furthermost anterior edge and the
furthermost posterior edge of the endplate 132.
[0068] As shown in FIG. 6, the radial collar 148 is centered upon
the plate 132 such that it is closer to the posterior edge 182 than
the anterior edge 180 of the plate. As a result, the center of
rotation 120 of the superior plate 132 is positioned to the
posterior of the lateral midline 122. In particular, the center of
rotation 120 is located a distance "d" behind the lateral midline
122. In a preferred embodiment, the center of rotation is about 1
mm to 3 mm posterior to the lateral midline. This posterior center
of rotation arrangement closely mimics the true anatomy of healthy
vertebral bodies and intervertebral discs.
Insertion Features
[0069] With continued reference to FIGS. 4-7, the endplates 132 and
134 of the prosthesis are designed with several features that allow
the prosthesis 130 to be more easily inserted into the
intervertebral space. For example, as best seen in FIG. 7, the
posterior side 182 of the endplate 132 is bulleted such that the
rear edge 176, left bevel 174, and right bevel 176 are all tapered
and provide a generally pointed edge. This tapered edge on the
posterior side 182 of endplate allows the endplate to be more
easily inserted into a collapsed intervertebral space if an
anterior approach is taken when inserting the prosthesis 130. In
particular, the tapered rear edge 176 provides a bulleted surface
to help wedge the prosthesis in the intervertebral space. In
addition, the left edge 184 and right edge 186 are tapered. These
tapered edges further allow the endplate to be more easily inserted
into a collapsed intervertebral space if a lateral approach is
taken when inserting the prosthesis 130.
[0070] While the posterior side 182 of the prosthesis 130 is
tapered, the anterior side 180 is more flat and blunt. As explained
in further detail below, this blunt side 180 provides a flat
anterior surface that may be pressed upon as the endplate is forced
into the intervertebral space during insertion from an anterior
approach.
[0071] In addition to the above, the prosthesis 130 includes a
central channel/slot 202 formed on the face of the superior plate
132, as shown in FIGS. 4 and 5. The central channel 202 is formed
by a left side rail 204 and a right side rail 206 that extend above
the face of the superior plate from the anterior side 180 to the
posterior side 182 and define the sides of the central channel 202.
As explained in further detail below, the central channel is
designed to engage a distracting ramp provided by an insertion arm
of on an disc insertion tool, thus facilitating insertion of the
prosthesis device into the intervertebral disc space.
[0072] In one alternative embodiment, the central channel 202 may
be defined by oblique rails or lateral rails that extend across the
face of the superior plate 130 at 45.degree. or 90.degree. angles
with respect to the rails 204 and 206 shown in FIGS. 4 and 5. Such
oblique rails or lateral rails would facilitate oblique or lateral
insertion of the intervertebral disc prosthesis 130.
[0073] In yet another alternative embodiment, the central channel
may be embedded in the face of the endplate, such as that shown in
FIG. 11. In this embodiment, the central channel 202 is defined by
a left side rail embedded in the face of the plate to form a left
side wall 205. Likewise the right side rail is embedded in the face
such that it forms a right side wall 207. The central channel 202
gradually ramps deeper into the face of the endplate from the
anterior to the posterior. In this embodiment, the endplate itself
becomes gradually thicker from the anterior side 180 to the
posterior side 182 of the endplate. This allows the endplate to
incorporate a lordotic angle in the sagittal plane of the
prosthesis. For example, if each endplate incorporates a
3.5.degree. angle from anterior to posterior, the intervertebral
prosthesis as a whole will incorporate a 7.degree. lordotic angle
in the sagittal plane. Endplates incorporating such a lordotic
angle may desirable for certain patients.
[0074] Another feature designed to assist with insertion of the
prosthesis device are retention surfaces in the form of
indentations positioned on the endplates, such as grooves, notches,
cavities, channels, crevices, or other recesses. As best seen in
FIGS. 4, 8 and 9, in one embodiment, the retention surfaces take
the form of grooves 210 formed by the collar 148 of the endplate.
The grooves 210 are dimensioned to receive and engage prongs or
"retaining arms" of the disc insertion tool, allowing the endplate
to be retained by the instrument during insertion, as explained in
further detail below. Preferably, the indentations are designed to
allow the insertion/distraction instrument to hold the endplates
and core of the prosthesis simultaneously to facilitate insertion
of the prosthesis as a unitary assembled piece. In an alternative
embodiment, such as that shown in FIG. 12, the indentations take
the form of notches 212 in the anterior corners on the left side
184 and right side 186 of the endplate 132. In this embodiment, the
prongs of the insertion/distraction instrument grasp the surface of
the endplate exposed by the notches 212 in order to hold the
endplate and encourage the endplate toward the intervertebral
space.
[0075] Another feature of the intervertebral prosthesis 130 are
lateral holding features, such as notches, holes, grooves,
indentations, protrusions or other structural features that provide
an easy means of grasping the endplates or the intervertebral
prosthesis 130 in general. Examples of lateral holding features
include the hole 220 in the central channel of FIG. 13 and the
notches 212 in the lower surface 142 of plate 132 in FIG. 12. These
lateral holding features facilitate non-anterior insertion of the
intervertebral prosthesis 130 and non-anterior revision/retrieval
of the prosthesis. In particular, the lateral holding features
provide structural components that may be easily grasped by
instrumentation that may be used to properly orient the prosthesis
130 during implantation or help retract an implanted prosthesis.
Alternatively, the groove 210 formed in the collar 148 of the
endplate could be a circumferential groove, such that an instrument
could attach to this groove from any direction, including anterior,
lateral, or posterior surgical approaches. An example of an
embodiment with the circumferential groove is shown in FIG.
12A.
[0076] With reference to FIG. 12A, an alternative embodiment of the
intervertebral disc prosthesis 130 includes additional insertion
features. In particular, an anti-rotation notch 218 is provided in
both the superior plate 132 and the inferior plate 134. The
anti-rotation notch 218 takes the form of a semi-cylindrical notch
carved in the anterior edge 181 of the endplate, extending from the
upper surface of the endplate to the lower surface of the endplate.
As explained in further detail below, the anti-rotation notch is
designed to engage a peg on the disc insertion tool, and prevent
rotation of the disc 130 during the insertion process.
[0077] As also shown in FIG. 12A, the intervertebral disc
prosthesis 130 may include a spring-arm detent 222 formed in each
endplate 132, 134. The spring arm detent 222 is formed in the lower
surface 142 of the superior plate 132 and the upper surface 152 of
the inferior plate 134. Each spring arm detent 222 extends
partially into the endplate and provides a small cavity designed to
receive the lip of a spring arm on a disc insertion tool. As
explained in further detail below, the interaction between the
detent 222 and the spring arm of the disc insertion tool provides
additional stability for the intervertebral disc prosthesis during
the implantation process.
Shear-Limiting Features
[0078] With reference to FIGS. 8 and 9, the intervertebral disc
prosthesis 130 is configured to allow the endplates 132 and 134 to
rotate/pivot from front-to-back and side-to-side. FIG. 8 shows a
cross-sectional view of the prosthesis 130 with the endplates 132
and 134 pivoting toward the left side. FIG. 9 shows a
cross-sectional view of the prosthesis 130 with the endplates 132
and 134 pivoting to the posterior side 182. As shown in both FIG. 8
and FIG. 9, the degree to which the endplates are allowed to pivot
is restricted by the radial flange 160 of the core 136. In
particular, when an endplate 132 or 134 rotates a certain degree
relative to the core 136, the collar 148 or 158 of the endplate
will contact the flange 160 of the core and thus prohibit further
pivoting of the endplate 132 or 134 relative to the core 136.
[0079] In an alternative embodiment, the radial flange 160 of the
core may be extended toward the inferior endplate or the superior
endplate to further limit or prevent articulation on that side of
the core. For example, with reference to FIG. 14A, the core 136
comprises a central disc portion 138 and a radial flange portion
160. The central disc portion includes an upper bearing surface 162
and a lower bearing surface 164. The convex upper bearing surface
162 engages the concave articulating surface 143 of the superior
plate 132, while the convex lower bearing surface 164 engage the
concave articulating surface 145 of the inferior plate 134. The
flange portion 160 is positioned in a ring-like fashion about the
central disc portion 138.
[0080] The flange portion 160 includes a radially extending portion
166 and a lip portion 168. The radially extending portion 166
extends outwardly from the central disc portion 138 in a radial
direction (relative to a vertical axis of the prosthesis). The lip
portion 168 extends in an axial direction relative to the radially
extending portion 166 and forms a ring about the central disc
portion 138. As explained in further detail below with reference to
FIGS. 15-17, the core 136 may be formed as an integral component or
a combination of materials and components.
[0081] In the embodiment of FIG. 14A, the lip portion 168 of the
flange 160 extends downward and encompasses the collar 158 of the
inferior plate 134 in the neutral position (i.e., with the endplate
un-pivoted relative to the core in the lateral bending plane or
flexion plane). However, in this embodiment, the lip portion 168 of
the flange 160 does not contact the surface of the endplate 134
around the collar 158 in the neutral position. This configuration
substantially limits the amount of pivoting allowed for the
inferior endplate relative to the core. At the same time, the lip
portion 168 of the flange extends only slightly upward and does not
encompass the collar 148 of the superior plate 132 in the neutral
position. This allows normal pivoting of the superior endplate 132
relative to the core 136.
[0082] In another embodiment, such as that shown in FIG. 14B, the
lip portion 168 of the flange 160 of the core 136 is configured to
extend completely to the inferior endplate 134 when the inferior
endplate is in the neutral position. Furthermore, the lip portion
168 of the flange 160 encases the collar 158 of the inferior
endplate when the endplate is in a neutral position. In this
embodiment, the lip portion 166 on the flange 160 of the core 136
substantially conforms to and engages an upper surface of the
inferior endplate 134, including the collar 158. In an alternative
embodiment, the lip portion 168 of the flange 160 of the core 136
is also configured to engage the groove 210 in the collar 158. Such
engagement between the lip portion 168 of the core 136 and the
groove 210 of the endplate 134 may be provided in a snap fit
engagement to secure the core 136 to the endplate 134. When
securing the core to the inferior endplate, the core may be
stretched and pressed to properly engage the lip portion 168 of the
flange 160 with the upper surface of the inferior endplate 134,
thus properly positioning the core 136 on the inferior endplate
134. After positioning the core 136 on the inferior endplate 134,
the extended flange 160 of the core, and particularly the lip
portion 168 of the flange 160, prevents the inferior endplate 134
from lateral bending and flexion relative to the core 136.
[0083] In addition to the above, it will be recognized from FIG.
14B that the fit between the flange 160 and the collar 158 of the
inferior endplate 134 may also prohibit or significantly restrict
torsional movement of the inferior endplate relative to the core.
In particular, if a relatively tight fit is provided between the
flange 160 and the collar 158, torsional movement will be prevented
or restricted. However, if a relatively loose fit is provided
between the flange 160 and the collar 158, torsional movement may
be allowed.
[0084] In yet another embodiment, the flange 160 extends to the
surface of the inferior endplate and includes protrusions that are
press-fit into holes or other indentations formed in the surface of
the inferior endplate 134. In this embodiment, the core 136 is
fixed to the inferior plate by the protrusions that fit into the
holes, intentionally preventing movement of the endplate 134
relative to the core 136. These protrusions on the core may be
press-fit into the holes in the inferior plate when the physician
assembles the prosthesis.
[0085] Each of the above embodiments are designed to limit the
amount of articulation between the endplates 132 and 134 and the
core 136 and thus provide shear resistance to help protect the
facets. Although the features have been shown with respect to the
inferior endplate 134, they could likewise be provided with respect
to the superior endplate 132.
Alternative Materials
[0086] As discussed above, the metal endplates 132, 134 may be
comprised of a cobalt chromium alloy. The core 136 may be comprised
of a plastic material such as ultra high molecular weight
polyethylene. Because plastic materials are typically not
radio-opaque, a cobalt chromium alloy wire may be provided around
the core to allow the physician to determine the location of the
core when viewing an x-ray image of an installed prosthesis. The
cobalt chromium alloy wire is typically inserted into a channel on
the core, such as channel 37 of FIG. 1 and channel 137 of FIG.
4.
[0087] In many cases, a physician may desire an MRI image rather
than an x-ray image of an implanted prosthesis. Unfortunately,
cobalt chromium alloy is not MRI compatible. Thus, in an
alternative embodiment of the prosthesis, the endplates 132 and
134, and the wire in the core channel 137, are all comprised of
titanium. The use of titanium allows the endplates and core wire of
an implanted prosthesis to be MRI compatible. Other MRI compatible
materials that could be used for the endplates and core wire
include ceramics, polycarbonate-polyurethane (PCPU),
polyetheretherketone (PEEK), or composites thereof.
[0088] In addition to alternative materials that make the
intervertebral prosthesis MRI compatible, other materials may be
advantageous to the surgeon, depending upon the desired outcome for
the patient. For example, a ceramic core could be used for
excellent wear performance in the youngest patients. A PCPU core
could be used to offer shock-absorbing capabilities for more active
patients.
Composite Core
[0089] In one embodiment, the core 136 is a composite core
comprised of a plurality of different portions made of different
materials exhibiting different properties. For example, FIGS. 15-17
show a plurality of different embodiments for a composite core
comprising at least two materials with different properties, joined
to form a single component. One embodiment of the composite core is
a dual durometer core having a relatively soft bearing surface and
a hardened flange.
[0090] With reference to FIGS. 15 and 15A, the core 136 is formed
as a three-part composite core comprising a central disc portion
163, an upper bearing portion 162, and a lower bearing portion 164.
The radial flange 160 is provided by the disc portion 163 and
encompasses a convex bearing surface 161. The bearing surface 161
is provided by the upper bearing portion 162 and the lower bearing
portion 164. The surface of the upper bearing portion 162 is
designed to engage the socket 149 of the superior endplate 132 and
the surface of the lower bearing portion 164 is designed to engage
the socket of the inferior endplate 134. The upper bearing portion
162 and lower bearing portion 164 are fixed to the disc portion 163
such that the core is provided as a unitary piece. The core 136 may
be configured such that the bearing portions 162, 164 attach to the
disc portion 163 by any number of different methods, such as
press-fit, threaded engagement, snap fit, welding, insert or
two-shot injection molding, insert compression molding, brazing,
bonding with adhesives, sintering, or other methods as will be
recognized by those of skill in the art.
[0091] Another embodiment of a composite core is shown in FIGS. 16
and 16A. In this embodiment, the core 136 is a two-part composite
core comprising a central bearing portion 262 and an outer ring
portion 264 encircling the central bearing portion. The top surface
261 of the central bearing portion 262 is designed to engage the
socket of the superior plate 132, and the bottom surface 263 of the
central bearing portion 262 is designed to engage the socket of the
inferior plate 134. The outer ring portion 264 is the flange 160 of
the core 136. When the central bearing portion 262 is comprised of
a relatively soft material and the outer ring portion 263 is
comprised of a relatively hard material, the ring portion 263 acts
as a retaining wall for the bearing portion 262, making the bearing
portion creep resistant. In particular, when the soft material of
the bearing portion 262 is compressed following implantation in the
patient, the harder material of the ring portion 263 prevents the
soft material of the bearing portion from deforming into a flatter
shape. Alternatively, the bearing portion 262 may be comprised of a
relatively hard wear-resistant material while the ring portion 263
may be comprised of a relatively resilient or tough material that
limits extreme motions, such as that shown in FIGS. 14 and 14A. The
core 136 may be configured such that the bearing portion 262 is
attached to the ring portion 163 by any number of different
methods, such as press-fit, snap fit, welding, insert or two-shot
injection molding, insert compression molding, brazing, bonding
with adhesives, sintering, or other methods as will be recognized
by those of skill in the art.
[0092] FIGS. 17, 17A and 17B show yet another embodiment of the
prosthesis core 136. In this embodiment, the prosthesis core 136 is
specifically designed to allow injection molding of two materials
using insert or two-shot molding, where a second material is molded
over a first material. As shown in FIG. 17A, the core comprises an
inner skeleton 266 of a first material and an outer bearing flesh
267 of a second material. The skeleton 266 is generally disc shaped
and the material of the skeleton extends continuously across the
core from one point on the flange 160 to an opposite point on the
flange. The skeleton also provides a ridge 269 where the bearing
flesh 267 abuts the skeleton 266. However, in certain locations on
the core 136, as shown in FIG. 17B, the skeleton does not extend
continuously across the core, and is interrupted by portions of
bearing flesh 267. This arrangement provides a cohesive part with
strong mechanical interconnections. Furthermore, if the bearing
flesh 267 is comprised of a relatively soft material and the
skeleton 266 is comprised of a relatively hard material, the flange
of the skeleton provides a retaining wall along with the ridge 269
to prevent creep of the soft bearing material during compression.
As discussed above, the arrangement shown in FIGS. 17-17B is
specifically configured for insert molding of the core.
[0093] From the above examples it will be clear that a core 136 may
be provided in multiple portions comprised of differing materials
such that the properties of the core vary from location to location
in an advantageous manner. For example, as discussed above, the
core may be manufactured in a manner such that the core provides a
soft bearing surface on the exterior and a rigid support skeleton
on the inside. As another example, the core may be manufactured
with a hard bearing surface and a relatively resilient
skeleton.
[0094] Example materials for use with the core include PEEK or
titanium with a wear-improving coating, PCPU, MMC, cobalt chromium
alloy, ceramics, double- network hydrogels, in addition to
ultra-high molecular weight polyethylene (UHMWPE). Alternate
combinations of interest from a wear perspective include metal
matrix composites (MMC) with cobalt chromium or MMC with ceramic.
Example ceramics include synthetic ruby, zirconia, alumina,
zirconia toughened alumina (ZTA), Y-TZP, silicon nitride, or
combinations thereof.
[0095] Examples of core material combinations and arrangements
include a ruby bearing portion brazed to a metal flange; a cobalt
chromium, titanium or stainless steel flange press fit around a
ceramic bearing; a MMC such as titanium with titanium carbide
bearing surface over a titanium skeleton;
polycarbonate-polyurethane (PCPU) or UHMWPE bearing surfaces
injection or compression molded over a metal flange insert; a
ceramic bearing with a PCPU or UHMWPE flange; or a PEEK bearing
with PCPU or a metal flange skeleton. As another example, a PCPU
core could be produced by multi-shot or insert injection molding a
relatively rigid central frame and flange with a relatively soft
outer bearing surface (e.g., shore 55D frame and shore 80A
bearing). In another example embodiment, layered sintering of MMC
to a similar metal results in a MMC bearing surface applied to a
metal frame, thus providing a bearing surface with ceramic-like
properties and a retention flange with non-ceramic (i.e.,
non-brittle) properties.
Modular Prosthesis Components
[0096] As described above, various configurations and compositions
are possible for the endplates 132, 134 and core 136. With a wide
variety of differing endplates and cores available, the surgeon may
desire a specific endplate and core combination based on the
particular needs of a patient. Therefore, the various endplates and
cores are made available to the surgeon as part of a modular
prosthesis system, where differing endplates may be matched with
any number of different cores to arrive at the desired prosthesis.
This provides the surgeon with a method of designing an
intervertebral disc prosthesis that is customized to the needs of
the particular patient.
[0097] When customizing the intervertebral prosthesis, the surgeon
analyzes and/or tests the patient to determine features that may be
desirable for the patient based on his or her particular situation.
These features may include, for example, material composition of
the prosthesis, structural features, and size of the prosthesis.
The surgeon then decides which features to include in the patient's
intervertebral prosthesis, and places an order for the desired
prosthesis with the prosthesis manufacturer. The surgeon's decision
to order certain structural features, sizes, or materials for the
prosthesis will likely be made based on the patient's concerns, the
patient's medical history, testing conducted on the patient, the
patient's age, the patient's size, the patient's health, the
patient's activity level, and the physician's general best
judgment. The surgeon's order includes a description of the desired
endplates as well as a description of the desired core. After the
customized prosthesis is ordered, a manufacturer or other assembler
puts together a prosthesis package for the physician and patient by
selecting the modular endplate and core components that provide the
desired prosthetic device. The components are then delivered to the
physician for implantation in the patient.
[0098] As an example of the modular prosthesis system in operation,
consider a particular situation where the patient is allergic to
nickel. In this situation, the surgeon will not want to use a
cobalt chromium endplate, since nickel is found in cobalt chromium
alloy, and the patient's body is likely to have an adverse reaction
to the nickel. However, because the prosthesis described herein may
be assembled from various modular components, the surgeon will have
the choice of selecting an endplate that contains no nickel, such
as a titanium endplate. In addition, the surgeon may determine that
a patient may benefit from a core having a rigid ceramic-like
bearing surface with a non-brittle and more cushioned retention
flange. For this core, the surgeon may use a core comprised of an
MMC material applied to a metal frame using layered sintering. As
another example, the surgeon may decide that movement of the
inferior endplate should be restricted for a particular patient. In
this case, the surgeon may order a prosthesis having a core similar
to that of FIG. 14B as opposed to the core shown in FIGS. 8 and 9.
In any case, the modular characteristics of the prosthesis system
described herein allow the surgeon to choose endplates and a core
that together provide the prosthesis that is most appropriate for
the patient.
[0099] After receiving an order for an intervertebral disc
prosthesis having a specified superior plate, core, and inferior
plate, the seller of the prosthetic devices obtains the appropriate
modular components and sends them to the physician. After receiving
the modular components, the physician assembles the components
before implanting the assembled prosthesis in the patient.
[0100] It should be recognized that various alternative methods of
ordering and order fulfillment of customized prosthetic devices are
available. Orders for customized prosthetic devices may be placed
by mail, telephone, on-line or by any other method known in the
art. In addition, the orders may be received, assembled and shipped
by a single entity or by different entities cooperating with each
other. Furthermore, the entity receiving and/or fulfilling the
order may be completely independent of the surgeon or associated
with the surgeon in some way. For example, a hospital may purchase
an array of modular components from a manufacturer and make custom
prosthetic devices available to surgeons associated with the
hospital. In this situation a surgeon would place an order for the
custom prosthetic device directly with the hospital. After
receiving the request for the custom prosthetic device, the
hospital would assemble the requested prosthetic device and deliver
it to the surgeon.
Insertion of Intervertebral Prosthesis
[0101] After selecting and receiving the proper endplates 132 and
134 and core 136 for a particular patient, the surgeon assembles
the intervertebral prosthesis 130 by sandwiching the core between
the endplates. Once assembled the prosthesis may be implanted in
the patient as a complete unit using an insertion/distraction
instrument.
[0102] In particular, with reference to FIG. 18 an intervertebral
prosthesis 130 is shown positioned within a disc insertion tool
300. The disc insertion tool 300 generally includes a handle 302
and associated lever 304. Separate insertion arms 306 extend from
the handle. The insertion arms 306 end in flat fingers 308 that
contact one another at a tip 310 opposite the handle 302. Holding
prongs/retention arms 312 are provided between the insertion arms.
The retention arms 312 are designed to retain the prosthesis 130 on
the disc insertion tool 300 by engaging the insertion features,
such as indentations 210, 212 positioned on the endplates 132 and
134, as discussed above. Activation of the lever 304 causes a
ratcheting operation that moves the insertion arms 312 and
prosthesis 300 toward the tip 310.
[0103] As shown in FIG. 19, once the old disc is removed from the
intervertebral space, the tip 310 of the disc insertion tool is
placed in the intervertebral space with blunt edges of the
insertion arms 306 positioned against the vertebral bodies 320. As
the prosthesis is gradually ratcheted toward the intervertebral
space the central channel 202 of the prosthesis 130 receives the
insertion arms/distracting ramp 306, and this engagement properly
orients and stabilizes the prosthesis 130 as it enters the
vertebral space. Furthermore, as the prosthesis is ratcheted
further and further down the insertion arms 306 toward the tip 310,
the prosthesis causes the insertion arms 306 to spread apart near
the tip 310. As the insertion arms 306 and fingers 308 are moved
apart, space is created between the vertebral bodies 320 for the
prosthesis 130.
[0104] The height of the fingers 308 in the intervertebral space is
greater than the height of the teeth 146 on the prosthesis 130.
This allows the prosthesis 130 to slide into position between the
vertebral bodies 320, moving along the insertion arms 306 and
fingers 308 without contacting the vertebral bodies 320 until the
fingers 308 are removed from the intervertebral space.
[0105] Stop blocks 314 are provided on the disc insertion tool
toward the rear of the retention arms 312. In one embodiment, the
position of the stop blocks 314 could be adjustable relative to the
insertion arms 312. The stop blocks 314 are designed to prevent the
prosthesis 130 from being inserted too far into the intervertebral
space. In particular, when the prosthesis 130 has been moved down
the insertion arms and to a position in the intervertebral space
such that the disc insertion tool should be removed, the stop
blocks 314 will contact the vertebral bodies 320 at the end of the
insertion arms 306. FIG. 20 shows the disc insertion tool 300 near
such a position. Continued ratcheting of the lever 304 at this
point causes the insertion arms 306 to retract from the vertebral
bodies 320, as the stop blocks 314 press against the vertebral
bodies. Once the insertion fingers 308 are removed from the
intervertebral space, the teeth 146 of the prosthesis 130 contact
the vertebral bodies 320. Natural compression of the prosthesis 130
by the vertebral bodies 320 causes the teeth 146 to sink into the
vertebral bodies, securing the prosthesis 130 in place between the
vertebral bodies. Bony in-growth between the endplate and bone
further secures the prosthesis in place over time.
[0106] An alternative embodiment of disc insertion tool 300 is
shown in FIGS. 21 and 22. This embodiment of the disc insertion
tool 300 is configured for use with the intervertebral disc
prosthesis shown in FIG. 12A. In this embodiment, the disc
insertion tool 300 includes anti-rotation pegs 318 as well as
spring arms 316. The anti-rotation pegs 318 are fixed to the
retention arms 312 of the disc insertion tool 300. One
anti-rotation peg 318 is provided on a top retention arm 312a and
another anti-rotation peg is provided on a lower retention arm 312b
(the lower anti-rotation peg is not shown in the figures). When the
anti-rotation pegs 318 are fully inserted into the anti-rotation
notches 218 of the disc prosthesis 130, as shown in FIG. 21, the
prosthesis 130 is prevented from rotating relative to the disc
insertion tool, thus maintaining the proper orientation of the disc
prosthesis during the implantation procedure.
[0107] The spring arms 316 are provided at the central back portion
of the retention arms 312. The spring arms 316 are cantilever arms
having resilient qualities that allow the spring arms to bend and
spring back into place. The spring arms 316 each include a lip
extending from the end of the spring arm. These lips are designed
to fit into the spring arm detents 222 of the disc prosthesis 130
(see FIG. 12A). When the lips of the spring arms 316 extend into
the spring arm detents 222, the disc prosthesis 130 is further
secured to the insertion tool 300 during the implantation process.
Once the disc prosthesis 130 is properly situated in the
intervertebral space, the spring arms 316 may be automatically
released, allowing the lips of the spring arms to move away from
the spring arm detents 222. With the spring arms 316 released, the
disc insertion tool 300 may be pulled away, leaving the disc
prosthesis 130 in place in the intervertebral space.
Alternative Embodiments Possible
[0108] Although the present invention has been described with
respect to certain preferred embodiments, it will be appreciated by
those of skill in the art that other implementations and
adaptations are possible. For example, the prosthetic disc
components shown in the attached drawings are most commonly
associated with artificial lumbar discs, but the features described
herein could also apply to other discs such as artificial cervical
discs.
[0109] Another example of a possible alternative embodiment is
shown in FIG. 9A. In this embodiment, the prosthesis 130 comprises
a superior endplate 132, inferior endplate 134 and an intermediate
core 136. However, unlike the embodiment of FIG. 9 which included a
socket and concave bearing surface on each endplate, the embodiment
of FIG. 9A includes opposing concave bearing surfaces 151 and 153
on the intermediate core 136. These concave bearing surfaces 151
and 153 respectively engage convex bearing surface 165 of the
superior plate 132 and convex bearing surface 167 of the inferior
plate 167. In this embodiment, the core 136 essentially provides
opposing sockets for the substantially spherical/ball-shaped
bearing surfaces of the endplates 132 and 134. The endplates 132
and 134 are thus configured to pivot upon the core 136, as the
bearing surfaces 165 and 167 of the endplates engage the bearing
surfaces 151 and 153 of the core.
[0110] In addition to the above, it should be recognized that there
are advantages to individual advancements described herein that may
be obtained without incorporating other aspects described above. In
view of the foregoing, the spirit and scope of the appended claims
should not be limited to the description of the preferred
embodiments contained herein.
* * * * *