U.S. patent application number 15/530859 was filed with the patent office on 2017-11-16 for prosthetic facet and facet joint replacement device.
This patent application is currently assigned to Spinal Kinetics Inc.. The applicant listed for this patent is Darin C. Gittings, Michael L. Reo, Janine C. Robinson. Invention is credited to Darin C. Gittings, Michael L. Reo, Janine C. Robinson.
Application Number | 20170325853 15/530859 |
Document ID | / |
Family ID | 37900215 |
Filed Date | 2017-11-16 |
United States Patent
Application |
20170325853 |
Kind Code |
A1 |
Gittings; Darin C. ; et
al. |
November 16, 2017 |
PROSTHETIC FACET AND FACET JOINT REPLACEMENT DEVICE
Abstract
Spinal stabilization devices, systems, and methods are
described. Foramenal spacers including a rigid member adapted to
maintain the integrity of the foramenal space. Facet joint
stabilizing members and prosthetic facet joints that augment or
replace the native facet joint are also described. Lateral spinal
stabilization systems that may be attached to the lateral surfaces
of adjacent vertebral bodies are described. Also described are
anterior spinal stabilization systems that are to be attached to
the anterior surfaces of adjacent vertebral bodies. Several
variations of dynamic spinal stabilization devices and systems are
described. Each of the foregoing devices, systems, and methods may
be used independently, in combination with the other devices,
systems, and methods described herein, and/or in combination with
prosthetic intervertebral discs.
Inventors: |
Gittings; Darin C.;
(Sunnyvale, CA) ; Reo; Michael L.; (Redwood City,
CA) ; Robinson; Janine C.; (Half Moon Bay,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Gittings; Darin C.
Reo; Michael L.
Robinson; Janine C. |
Sunnyvale
Redwood City
Half Moon Bay |
CA
CA
CA |
US
US
US |
|
|
Assignee: |
Spinal Kinetics Inc.
Sunnyvale
CA
|
Family ID: |
37900215 |
Appl. No.: |
15/530859 |
Filed: |
March 9, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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11234481 |
Sep 23, 2005 |
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15530859 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2/4405 20130101;
A61B 17/7071 20130101; A61F 2/442 20130101; A61F 2002/4495
20130101; A61B 17/7064 20130101; A61F 2002/30578 20130101; A61B
2017/00867 20130101; A61F 2002/30563 20130101 |
International
Class: |
A61B 17/70 20060101
A61B017/70; A61F 2/44 20060101 A61F002/44 |
Claims
1. A facet stabilizing member having a size and shape suitable for
placement in a spinal facet joint and to provide stabilization to
the facet joint comprising: a.) a core member comprising a
polymeric material for providing shock absorbing and spacing in the
facet joint, and b.) a woven jacket encasing the core member,
selected to maintain the shape of the core member.
2. The facet stabilizing member of claim 1 where the polymeric
material of the core member is selected from hydrogel and
urethane.
3. The facet stabilizing member of claim 1 where the jacket is a
woven fabric.
4. A facet stabilizing member having a size and shape suitable for
placement in a spinal facet joint and to provide stabilization to
the facet joint comprising: a. an upper end plate with a fixation
member configured to be fixed to a facet, b. a lower end plate with
a fixation member configured to be fixed to a facet, and c. a core
member extending between and interconnecting the upper and lower
end plates comprising a polymeric material for providing shock
absorbing and spacing in the facet joint and further comprising
fibers wound between the upper and lower end plates.
5. The facet stabilizing member of claim 4 where the polymeric
material of the core member is selected from hydrogel and
urethane.
6. An inter-spinous process, dynamic stabilizing device
interposable between spinous processes associated with a first
vertebral body with a first spinous process and a second vertebral
body with a second spinous process, the second vertebral member
being adjacent said first vertebral body, said device comprising:
a. upper and lower spinous process attachment members for
attachment, respectively, to the first spinous process and to the
second spinous process, and b. two spring members, each spring
member extending between, attached to, and lateral of both of the
upper and lower spinous process attachment members.
7. The inter-spinous process, dynamic stabilizing device of claim 6
wherein the upper and lower spinous process attachment members are
U-shaped to accept first and second spinous process members.
8. The inter-spinous process, dynamic stabilizing device of claim 7
wherein the upper and lower spinous process attachment members
further comprise screws to secure the upper and lower spinous
process attachment members to the first and second spinous process
members.
9. The inter-spinous process, dynamic stabilizing device of claim 6
wherein the spring members comprise a shape-memory alloy.
10. The inter-spinous process, dynamic stabilizing device of claim
6 wherein the spring members comprise nitinol.
11. The inter-spinous process, dynamic stabilizing device of claim
10 wherein the spring members comprise a nitinol alloy chosen to
allow adjustment of spring shapes, spring size, or performance
characteristic upon application of heat to the spring members.
12. A dynamic stabilizing system interposable between an upper
vertebral body and a lower vertebral body, the lower vertebral body
being adjacent said first vertebral body, said system comprising:
a. a posterior stabilization device attachable both to the
posterior of the upper vertebral body and to the posterior of the
lower vertebral body, and comprising one or more members selected
from springs and dampers, and b. an anterior stabilization device
attachable both to the anterior of the upper vertebral body and to
the anterior of the lower vertebral body, and comprising a member
constrainable by rolling or folding for implantation onto the
anterior of the upper vertebral body and onto the anterior of the
lower vertebral body and further, upon release of the constraint,
for attachment to the anterior of the upper vertebral body and to
the anterior of the lower vertebral body.
13. The dynamic stabilizing device of claim 12 wherein the
posterior stabilization device is attached both to the posterior of
the upper vertebral body and to the posterior of the lower
vertebral body.
14. The dynamic stabilizing device of claim 12 wherein the anterior
stabilization device is attached both to the anterior of the upper
vertebral body and to the anterior of the lower vertebral body.
15. The dynamic stabilizing device of claim 12 further comprising
bone screws for attaching the posterior stabilization device both
to the posterior of the upper vertebral body and to the posterior
of the lower vertebral body and for attaching the anterior
stabilization device both to the anterior of the upper vertebral
body and to the anterior of the lower vertebral body.
16. A dynamic stabilizing system interposable between an upper
vertebral body with upper transverse processes and a lower
vertebral body with lower transverse processes, the lower vertebral
member being adjacent the upper vertebral body, the system
comprising: a. two inter-transverse process stabilization members
each extendable between and attachable to an upper transverse
process and a lower transverse process, and b. upper and lower bone
screws for attaching the two inter-transverse process stabilization
members to the upper transverse process and to the lower transverse
process.
17. The dynamic stabilizing system of claim 16 where each of the
inter-transverse process stabilization members comprises one or
more members selected from springs and dampers.
Description
RELATED APPLICATIONS
[0001] This is a divisional of Ser. No. 12/927,208, filed Nov. 8,
2010, entitled "PROSTHETIC FACET AND FACET JOINT REPLACEMENT
DEVICE," which, in turn is a continuation-in-part of U.S. patent
application Ser. No. 11/234,481, filed on Sep. 23, 2005, entitled
"SPINAL STABILIZATION SYSTEMS AND METHODS" which is also a
continuation of U.S. patent application Ser. No. 11/540,044, filed
Sep. 29, 2006, entitled "PROSTHETIC FACET AND FACET JOINT
REPLACEMENT DEVICE" the entirety of which are incorporated by
reference, for all purposes.
BACKGROUND
[0002] The spine is comprised of twenty-four vertebrae that are
stacked one upon the other to form the spinal column. The spine
provides strength and support to allow the body to stand and to
provide flexibility and motion. Each vertebra includes an opening
through which the spinal cord passes enabling the spine to protect
the spinal cord. The spinal cord includes thirty-one pairs of nerve
roots that branch from either side of the spinal cord, extending
through spaces between the vertebrae known as the neural
foramen.
[0003] Between each pair of vertebrae is an intervertebral disc.
The disc is composed of three component structures: (1) the nucleus
pulposus; (2) the annulus fibrosus; and (3) the vertebral
endplates. The disc serves several purposes, including absorbing
shock, relieving friction, and handling pressure exerted between
the superior and inferior vertebral bodies associated with the
disc. The disc also absorbs stress between the vertebral bodies,
which stress would otherwise lead to degeneration or fracture of
the vertebral bodies.
[0004] Disorders of the spine are some of the costliest and most
debilitating health problems facing the populations of the United
States and the rest of the world, costing billions of dollars each
year. Moreover, as those populations continue to age, the incidence
of spinal disorders will continue to grow. Typical disorders
include those caused by disease, trauma, genetic disorders, or
other causes.
[0005] The state of the art includes a number of treatment options.
Medicinal treatments, exercise, and physical therapy are typical
conservative treatment options. Less conservative treatment options
include surgical intervention, including microdiscectomy,
kyphoplasty, laminectomy, dynamic stabilization, disc arthroplasty,
and spinal fusion. Traditionally, these treatment options have been
utilized in isolation, rather than in combination, and the most
conservative of the treatment options utilized to provide a desired
result.
[0006] U.S. Provisional Patent Application Ser. No. 60/713,671,
entitled "Prosthetic Intervertebral Discs," ("the '671
application"), was filed Sep. 1, 2005, and is assigned to Spinal
Kinetics, Inc., the assignee of the present application. The '671
application describes, inter alia, a treatment option that combines
a prosthetic intervertebral disc with a dynamic stabilization
system. The '671 application is incorporated by reference herein in
its entirety.
[0007] In 1992, Panjabi introduced a model of a dynamic spinal
stabilization system that describes the interaction between
components providing stability in the spine. This model defined
spinal instability in terms of a region of laxity around the
neutral resting position of a spinal segment, identified as the
"neutral zone." Panjabi, M M., "The stabilizing system of the
spine. Part II. Neutral zone and instability hypothesis." J Spinal
Disord 5 (4): 390-397, 1992b. There is some evidence that the
neutral zone increases as a result of intervertebral disc
degeneration, spinal injury, and spinal fixation. Id. Panjabi has
subsequently described dynamic stabilization systems that provide
increased mechanical support while the spine is in the neutral zone
and decreased support as the spine moves away from the neutral
zone. See United States Published Patent Application No.
2004/0236329, published Nov. 25, 2004, which is hereby incorporated
by reference herein.
SUMMARY
[0008] We describe spinal stabilization components, systems, and
methods for their use. The spinal stabilization components are
suitable for use individually, together, or with other known spinal
stabilization components and systems.
[0009] We describe foramenal spacers and methods for their use. The
foramenal spacer includes a member having a size and shape suitable
for insertion into the foramen located between a pair of adjacent
vertebral bodies to prevent the pair of vertebral bodies from
collapsing into one another, i.e., to maintain the interpedicular
spacing between the adjacent vertebral bodies. The foramenal spacer
may also include a passageway or include another member protecting
the nerve root from being compressed or otherwise physically
impacted as it traverses the foramen. The foramenal spacer may
include an upper C-shaped member, a lower C-shaped member that
interconnects with the upper C-shaped member, and an optional
attachment member for attaching the upper C-shaped member to the
lower C-shaped member. The upper C-shaped member is adapted to be
attached to the pedicle of the superior vertebral body and to
extend into the foramen defined by the pair of vertebral bodies,
while the lower C-shaped member is adapted to be attached to the
pedicle of the inferior vertebral body and to extend into the
foramen defined by the pair of vertebral bodies. When attached
together, the upper and lower C-shaped members define a passageway
for passage of the nerve root. The attachment feature may comprise
a tongue and groove mechanism, a snap-fit mechanism, or other
suitable mechanism for attaching the upper and lower C-shaped
member together. The upper C-shaped member and lower C-shaped
member may each be provided with surfaces adapted to butt up
against one another to form a butt-joint. The C-shaped members may
be mated in such a way that they allow some travel (e.g.,
extension) relative to each other, such as that which may be
required during flexion, extension and lateral bending, and
maintain the patency of the passageway to allow passage of the
nerve root.
[0010] Another of our foramenal spacers includes an upper segment
and a lower segment. The upper segment is attachable to the pedicle
of the superior vertebral body and extends into the foramen defined
by a pair of vertebral bodies; the lower segment is attachable to
the pedicle of the inferior vertebral body and also extends into
the foramen defined by the pair of vertebral bodies. The interior
surface of one of the upper segment or the lower segment and the
external surface of the other of the upper segment or the lower
segment define a pair of rounded, mating surfaces that together
define a bearing structure that allows the upper segment to pivot
relative to the lower segment. The upper segment and lower segment
thereby act as a bearing having a center of rotation. Once the
upper segment and lower segment are attached to the respective
vertebral bodies and are engaged with one another, the foramenal
spacer provides a supporting structure that also protects the nerve
root traversing the foramen, and that allows the superior and
inferior vertebral bodies to pivot relative to one another.
[0011] The foramenal spacer may be formed of a rigid biocompatible
material, e.g., metal alloys such as stainless steel, nitinol,
tantalum, or other metallic materials, or a rigid polymeric
material. The foramenal spacer may be provided with an outer layer
formed of a soft, conformable material (e.g., an elastomeric
polymer such as polyurethane) that provides conformability with the
foramen geometry and allows flexion, extension, and lateral bending
of the spine. The foramenal spacer may include an inner liner
formed of a soft and/or low-friction material to provide an
atraumatic surface for passage of the nerve root.
[0012] We also describe devices, systems, and methods for facet
joint augmentation and replacement. The devices and systems are
intended to stabilize the spine and to increase the foramenal space
to thereby reduce the likelihood of nerve root impingement.
Stabilization and increase of foramenal space is accomplished by
inserting a stabilizing member into the facet joint to restore the
intra-foramenal distance. The stabilizing member may be made up of
a structure that provides shock absorbance, cushioning, and support
to the facet joint comprising, e.g., an encapsulated cushion. The
stabilizing member may comprise a structure having a pair of
endplates separated by a resilient core member.
[0013] In another variation, we describe facet joint implants. They
are used in a procedure replacing some or all of the facets of each
of the superior and inferior vertebral bodies. Our facet joint
implant may include an upper prosthetic facet for attachment to the
superior vertebral body, and a lower prosthetic facet for
attachment to the inferior vertebral body. Each prosthetic facet is
attached to its respective vertebral body by fasteners such as
screws or the like. Each prosthetic facet joint of this design
includes a pair of facing plates and a core member located between
the pair of facing plates. The prosthetic facet is constructed and
attached in a manner such that it closely mimics the functionality
and performance of the natural facet joint.
[0014] We also describe a lateral spinal stabilization device. That
lateral spinal stabilization device includes an upper attachment
member and a lower attachment member for attaching to adjacent
upper and lower vertebrae, respectively, and a stabilizing member
connected to and extending between the upper and lower attachment
members. The stabilizing member may comprise a damping mechanism or
may comprise a pair of endplates separated by a resilient core
member.
[0015] We also describe an anterior spinal stabilization device
that is attached to the anterior surfaces of a pair of vertebrae
that comprises a spring having a structure sufficient to carry a
load after implantation. The anterior stabilization device may be
implanted by way of a minimally invasive anterior approach,
although posterior and lateral approaches are also suitable.
[0016] We also describe several dynamic stabilization devices are
described. Each of the dynamic stabilization devices provides a
combination of stabilizing forces to one or more spinal units to
thereby assist in bearing and transferring loads. One dynamic
stabilization device includes a posterior spacer member that is
located between a pair of spinous processes on adjacent vertebral
bodies. The posterior spacer may be formed of a generally compliant
material and maintains spacing between the pair of adjacent
vertebral bodies while allowing relative motion between the
vertebral bodies. The posterior spacer may be in the form of a
short cylinder or large bead-like structure, having a central
through-hole to allow passage of one or more restrictor bands. The
spacer itself may take other shapes or forms, however, depending
upon the size and shape of the spinal treatment site.
[0017] This dynamic stabilization device may also include one or
more elastic restrictor bands. The restrictor bands each have a
size and shape allowing attachment to the spinous processes of
adjacent vertebral bodies or attachment to the lamina of the
adjacent bodies. Once linked to the posterior of the spine, the
bands provide both stability and compliance. The performance
properties of the bands may be varied by choice of materials, size
of the bands, and by the routing of the restrictor bands between
adjacent vertebral bodies. For example, restrictor bands that are
oriented more vertically than diagonally will provide greater
resistance to flexion of the spine, while a more diagonal
orientation will provide additional resistance to torsional
movements.
[0018] We also describe dynamic stabilization devices that may be
adjusted post-operatively. For example, one variation of our
dynamic stabilization device is made up of upper and lower
attachment members for attachment to pedicles of adjacent vertebrae
and one or more spring members extending between those attachment
members. The spring member may be formed of a shape memory
material, such as nitinol. Using a shape memory material such as
nitinol allows alteration of the shape or length of the spring
member by heating the spring, perhaps by applying an electric
current to the spring. The electric current may be applied by
placing leads against the spring member under X-ray or other
guidance. A given spring member may be extended or contracted to
provide greater or lesser load support, or to alter any other
performance characteristic of the device.
[0019] We describe another spinal stabilization device that
stabilizes the spine by transferring motions taking place (and
correlated spinal loadings) in one spinal segment to an adjacent
segment. Our spinal stabilization device transfers loads and
reactions in the same manner as is done by the natural spinal
segments operating properly. The spinal stabilization device is
affixed to three adjoining vertebrae and allows for rotation of
component linkage members about the center vertebral member,
thereby allowing the functional transfer of load, either in
compression or torsion, from one region of the spine to an adjacent
vertebral region.
[0020] Another variation of our dynamic stabilization device
includes a combination of an interspinous stabilization member and
one or more pedicle based stabilization members. The pedicle based
stabilization members function by biasing the pair of adjacent
vertebral bodies apart, while the interspinous stabilization member
functions by biasing together the spinous processes of the adjacent
pair of vertebral bodies. The combined action of the interspinous
member and the pedicle based members creates a moment arm that
relieves pressure from the disc.
[0021] Another dynamic stabilization device is attached to a pair
of adjacent vertebrae via their transverse processes and includes
loading member extending between and interconnects the upper and
lower transverse processes. Cooperating attachment members for the
stabilization device may extend through the transverse processes
into the vertebrae, or may be attached to the vertebrae adjacent to
the transverse processes.
[0022] We describe dynamic stabilization devices that may be
located externally of the patient's skin surface. Such
stabilization members may be attached to a pair of adjacent
vertebrae and extend between the vertebrae exterior of the patient.
The device may be fully adjustable.
[0023] Such an external dynamic stabilization device may include a
fill-type adjustment mechanism. Such device may be attached to the
spinous process of an upper vertebral body and to the spinous
process of a lower vertebral body and include a stabilization
member extending between those vertebrae. The device may include
adjustment members comprising fillable pots. As the pot is filled
with a settable material, such as an epoxy, bone cement (e.g.,
containing polymethylmethacrylate (PMMA)), the functional length of
the member is fixed.
[0024] Finally, we describe a dynamic stabilization device having
an intervertebral spacer with an integrated stabilizing disc, the
combined unit being situated between the spinous processes of
adjacent vertebrae.
[0025] Each of the described devices, structures, and methods may
be used independently, or in combinations of two or more. Indeed,
each of the foregoing devices may be used in combination with a
prosthetic intervertebral disc to obtain desired therapeutic
results.
BRIEF DESCRIPTION OF THE FIGURES
[0026] The Figures are not necessarily drawn to scale. Some
components and features have been exaggerated for clarity.
[0027] FIG. 1 is a lateral view of a pair of adjacent vertebral
bodies, including representation of the foramen and nerve roots
traversing the foramen.
[0028] FIGS. 2A-G are illustrations of foramenal spacers.
[0029] FIG. 3 is a posterior view of a pair of adjacent vertebral
bodies, including representations of the facets and facet
joints.
[0030] FIG. 4 is a perspective view of an embodiment of a facet
joint stabilizing member.
[0031] FIG. 5 is a side view of another embodiment of a facet joint
stabilizing member shown implanted in a facet joint.
[0032] FIG. 6A is a view of a number of prosthetic facets and facet
joints implanted upon a spine.
[0033] FIG. 6B is a partial side view of a prosthetic facet and
facet joint assembly.
[0034] FIGS. 6C and 6D are front and side views of a prosthetic
facet and facet joint assembly.
[0035] FIG. 7 is an illustration of a portion of a spinal column
with a prosthetic facet and facet joint assembly having a pair of
prosthetic facet joints.
[0036] FIG. 8 is a lateral view of a pair of vertebral bodies
having a lateral stabilization device implanted between them.
[0037] FIG. 9A is a lateral view of a pair of vertebral bodies
having an anterior stabilization device and a posterior
stabilization device.
[0038] FIG. 9B is an illustration of an anterior stabilization
device.
[0039] FIG. 10A is an illustration of a spacer member.
[0040] FIGS. 10B-10F are illustrations of posterior dynamic
stabilization devices including a spacer member and restrictor
bands both as implanted on the spine and isolated from the
spine.
[0041] FIG. 11 is a posterior view of another dynamic stabilization
system.
[0042] FIG. 12A is a posterior, schematic view of a dynamic
stabilizer traversing two adjoining discs.
[0043] FIGS. 12B and 12C are, respectively, front and side views of
one element of the dynamic stabilizer shown in FIG. 12A.
[0044] FIG. 12D shows the end of the element shown in FIGS. 12B and
12C.
[0045] FIGS. 12E to 12F show movement of the elements during
rotation of the spine.
[0046] FIG. 13A is a side view of another dynamic stabilization
system. FIG. 13B is a schematic showing rotation and reaction when
the FIG. 13A device is deployed.
[0047] FIG. 14 is a posterior view of another dynamic stabilization
system.
[0048] FIG. 15 is a lateral view of another dynamic stabilization
system.
[0049] FIG. 16 is a lateral view of another dynamic stabilization
system.
[0050] FIG. 17 is a lateral view of another dynamic stabilization
system.
[0051] FIG. 18 is a perspective, cross-sectional view of one
example of a prosthetic intervertebral disc.
DESCRIPTION
[0052] FIG. 1 illustrates a pair of adjacent vertebrae, including a
superior or upper vertebral body (100) and an inferior or lower
vertebral body (102). Upper vertebral body (100) includes a pair of
transverse processes (104a, 104b) and a spinous process (106)
extending generally posteriorly. Lower vertebral body (102)
includes a pair of transverse processes (105a, 105b) and a spinous
process (107). A disc (108) is located between the superior
vertebral body (100) and the inferior vertebral body (102). The
spinal cord (110) extends through a central passage formed by the
spinal column, and nerve roots (112) transverse the foramenal space
(114) defined by the pair of vertebral bodies.
[0053] When the disc is damaged due to trauma, disease, or other
disorder, the superior vertebral body (100) and inferior vertebral
body (102) tend to collapse upon each other, thereby decreasing the
amount of space formed by the foramen (114). This result also
commonly occurs when the vertebral bodies are afflicted with
disease or are fractured or otherwise damaged. When the foramenal
space is decreased, the vertebral bodies (100, 102) may impinge
upon the nerve root (112), causing discomfort, pain, and possible
damage to the nerve root. The foramenal spacers described herein
are intended to alleviate this problem by maintaining the foramenal
opening and otherwise protecting the nerve root from impingement by
the vertebral bodies.
[0054] Turning to FIGS. 2A through 2G, several foramenal spacer
embodiments are shown. In a first embodiment, shown in FIGS. 2A-D,
the foramenal spacer (120) includes a pair of C-shaped members
(122, 124). The C-shaped members may include an attachment
mechanism or mating surfaces. For example, as shown in FIG. 2B, one
C-shaped member (122) includes a groove or notch (126) on each of
its inferior-facing surfaces (128), and the other C-shaped member
(124) includes a mating tab (130) on each of its superior-facing
surfaces (132). Alternatively, the tabs and notches may be
alternated, one on one member and one on the other. Other
attachment features may be employed, such as a snap-fit mechanism
or other similar structure. Of course, the mating surfaces (128,
132) may simply butt up against one another to form a butt-joint
that prevents collapse of the foramenal space. In any case, the
pair of C-shaped members (122, 124) define a generally disc-shaped
member (134) having a central through-hole (136). The central
through-hole (136) has a size and shape suitable for passage of
nerve root (112) without impingement as shown, for example, in
FIGS. 2C and 2D.
[0055] Turning to FIG. 2E, the foramenal spacer (120) may be
provided with an outer layer (140) that includes a coating of a
soft, conformable material. The outer layer (140) may cover all of
the external-facing surfaces of the foramenal spacer (120), and
particularly those that are positioned to engage the vertebral body
surfaces. The outer layer (140) may comprise a soft, conformable
biocompatible material such as silicone, polyurethane, or other
similar polymeric materials. The outer layer (140) helps to provide
structural protection to the vertebral bodies forming the foramenal
space, and also allows the foramenal spacer (120) to adapt to the
varying foramenal geometries formed by the vertebral bodies.
[0056] An optional inner layer or liner (142) may be provided on
the exposed surfaces defining the through-hole (136) of a coating
of soft and/or low-friction material to provide an atraumatic
surface for passage of the nerve root (112). The inner layer or
liner (142) may comprise the materials similar to those used for
the outer layer (140). Alternatively, the inner layer or liner
(142) may comprise a coating of lubricious materials such as
polyethylene, PTFE, or other similar material.
[0057] In addition, an optional spring member, gasket, cushion, or
other similar material or device (not shown in the drawings) may be
interposed between the two C-shaped members (122, 124). Preferably,
the spring member (or the like) may be located between the abutting
surfaces of the two C-shaped members. This spring member (or the
like) expands the spacer (120) with as the spring member extends
and compresses, thereby providing a range of motion for supporting
the foramenal space.
[0058] FIG. 2F shows a variation of our foramenal spacer. The
foramenal spacer (120) includes a first segment (150) and a second
(or inner) segment (156). The first segment (150) includes an
external surface (152) that has a shape suitable for engaging the
portion of a vertebral body defining the foramenal space (114).
Similarly, the other segment (156) includes an external surface
(158) that has a shape adapted to engage a portion of the adjoining
vertebral body defining the foramenal space (114). An internal
surface (154) of the first segment (150) includes a curved portion
that rotatably engages a mating curved portion of the external
surface (158) of segment (156). In this way, the segments (150,
152) are rotationally connected to one another, i.e., the segments
(150, 152) function similarly to a bearing having a center of
rotation. When the first segment (150) and second segments (152)
are implanted into the foramenal space between vertebral bodies
(100, 102), the foramenal spacer (120) allows the two vertebral
bodies to pivot relative to one another, thereby providing an
additional range of motion. The foramenal spacer (120) shown in
FIG. 2F may also include an outer layer (140) and an inner layer or
liner (142) described above in relation to FIG. 2E.
[0059] The foramenal spacer (120) may be implanted by any
appropriate surgical technique, including accessing the foramenal
space by either a posterior approach or a lateral approach. The
lateral approach is believed to provide optimal access for exposure
of the foramen, but techniques for posterior lumbar interbody
fusion (PLIF) and transforamenal lumbar interbody fusion (TLIF)
also provide sufficient access. Once access is gained, the
foramenal spacer (120) is attached to the pedicle or other anatomic
structure that allows extension of the spacer into the foramenal
space (114). Depending upon the specific design of the device, the
foramenal spacer (120) may be press fit into the foramen (116).
FIG. 2G shows a foramenal spacer (120) having a tab (157) with an
opening (159) for attaching the foramenal spacer (120) to the
pedicle or other anatomical structure.
[0060] Turning next to FIG. 3, a posterior view of a pair of
adjacent vertebral bodies is shown. The Figures illustrates a
superior vertebral body (100) and an inferior vertebral body (102).
Each vertebral body includes a pair of transverse processes (104a-b
and a spinous process (106) extending generally posteriorly from
each vertebral body (100, 102). The spinal cord (110) extends
through a central passage formed by the spinal column, and nerve
roots (112) transverse the foramenal space (114) defined by the
pair of vertebral bodies. A facet joint (118) is formed by a pair
of facing facets, one each from the superior and inferior vertebral
bodies.
[0061] Several of the known devices and systems for posterior
spinal stabilization are designed and provide the function of
opening the foramen or maintaining the foramenal spacing in order
to off-load the nerve that traverses the foramen. This is commonly
done by attaching a device to the pedicles of each of the vertebral
bodies and providing a distracting force between the attachment
members. Several alternative and novel devices and methods are
described herein.
[0062] FIG. 4 shows a facet stabilizing member (170). The facet
stabilizing member (170) preferably includes a core member (172)
encased in a jacket (174). The core member (172) may comprise a
hydrogel, gel, elastomer, polyurethane, or other polymeric material
suitable for providing the shock absorbing and spacing functions
necessary to stabilize the facet joint. The jacket (174) may be a
fabric (woven or unwoven) of biocompatible material and is intended
to maintain the integrity and shape of the core member (172) and to
otherwise provide structural strength to the facet stabilizing
member (170). The facet stabilizing member (170) has a size and
shape suitable for placement in the facet joint (118) and provide
stabilization to the joint and to prevent collapse of the foramenal
space.
[0063] FIG. 5 shows another variation of our facet stabilizing
member (170). The depicted spinal stabilizing member (170) includes
an upper endplate (180), a lower endplate (182), and a core member
(184) extending between and interconnecting the upper endplate
(180) and lower endplate (182). The facet stabilizing member also
includes a plurality of fibers (186) wound between and
interconnecting the upper endplate (180) and lower endplate (182).
The construction and materials of the facet stabilizing member
(170) shown in FIG. 5 are similar to the construction and materials
of the prosthetic intervertebral disc described below in relation
to FIG. 18, and to several of the prosthetic intervertebral discs
described in U.S. patent application Ser. No. 10/903,276, filed
Jul. 30, 2004, and U.S. Provisional Application Ser. No.
60/713,671, filed Sep. 1, 2005, each of which is incorporated by
reference. Other prosthetic disc constructions as described in the
foregoing applications are also suitable for use in the facet
stabilizing members (170) described herein. The size of the facet
stabilizing member (170) is typically smaller than the sizes of the
prosthetic discs described in the foregoing applications, but the
overall construction of the structure may be the same.
[0064] The facet stabilizing member (170) is implanted between the
pair of opposed facets associated with the pair of adjacent
vertebral bodies. Additional features, such as fins, fixation
members, or other structures (not shown), may also be incorporated
on the facet stabilizing member (170) to limit movement. The facet
joint is synovial; implantation may be performed through the
capsule. Access to the facet joint may be obtained by any of the
methods described above in relation to implantation of the
foramenal spacer.
[0065] FIGS. 6A to 7 shows several variations of our prosthetic
facet and facet joint assemblies. These assemblies are particularly
useful in repairing spinal structure compromised, e.g., during
spinal surgical procedures, particularly those including approach
by the posterior, where some of or the entire facet is removed to
implant one or more prosthetic structures. The devices are
similarly suitable in cases where the facets or facet joints are
damaged through trauma, disease, or other disorder to stabilize to
the effected spinal segments.
[0066] FIG. 6A shows a number of combination prosthetic facet and
facet joint assemblies (190) implanted in several locations on a
spinal column. The native facet and facet joint is removed prior to
implanting the prosthetic assembly. Each depicted prosthetic facet
assembly (190) includes an upper attachment arm (192) that, as may
be seen in the side view of FIG. 6D, is generally elongated and
curved forward to match the shape and structure of the prepared
native facet. The depicted upper attachment arm (192) is attached
to or terminates in an endplate (194) forming a portion of a facet
stabilizing member (170). The upper attachment arm (192) is
attached to its associated vertebral body by appropriate fasteners,
e.g., one or more screws (196). The facet stabilizing member (170)
may be similar in construction and materials of construction to
those described above in relation to the FIG. 5, above. The
assembly (190) also includes a lower attachment arm (193) that is
also generally elongated and curved rearward (again, as seen in the
side view of FIG. 6D) to match the shape and conform to the
structure of the prepared native facet on the lower vertebral
body.
[0067] The facet stabilizing member (170) is interposed between a
pair of prosthetic facets (190, 193) with the facet endplates (194)
serving as the endplates for the facet stabilizing member (170).
(See, in particular, FIG. 6B). In general, in designing a specific
combination prosthetic facet and facet joint assembly (190), the
facet stabilizing member (170) is sized and oriented with respect
to the prosthetic facets (190, 193) to approach several physical
parameters of the facet joint that has been removed. Those
parameters include: compressibility, increasing compressibility
rate as a function of compression, the ability to limit local
spinal rotation to a certain small value, and the ability to rotate
in a range of normal values without causing an abnormal or
unacceptable rotational movement in the adjacent joints. As shown
in FIG. 6A, the facet stabilizing member (170) is generally
oriented with respect to the prosthetic facets (190, 193) so that
it matches or approaches the orientation of the native facet joint
with respect to the respective vertebrae. Obviously, the
orientation of combination prosthetic facet and facet joint
assembly (190) and its included facet stabilizing member (170) is
different for each facet site on the spine. Often, the combination
prosthetic facet and facet joint assemblies (190) are implanted in
matching (mirror image) pairs on each side of a vertebral body to
assure conforming performance.
[0068] FIG. 7 illustrates a multi-level stabilization assembly
(195) having prosthetic facets and facet joints. The assembly (195)
extends over several adjacent vertebral segments using several
facet stabilizing members (170). The depicted assembly (195)
includes an elongated lower attachment arm (193) that is curved
rearward to match the shape and conform to the structure of the
prepared site on the sacrum (119). The assembly (195) also includes
an elongated upper attachment arm (192) that is curved rearward to
match the shape and conform to the structure of the prepared site
on the uppermost vertebrae (199), shown as the L-4 vertebra in the
drawing. Included in this assembly is a double-ended mid-attachment
member (197) that serves to connect the two facet stabilizing
members (170), the mid-vertebra (201) or L-5, and indirectly
through the two facet stabilizing members (170), lower attachment
arm (193) and the upper attachment arm (192). The native facets and
associated facet joints would be removed prior to the implantation
of the multi-level stabilization assembly (195). Again, a pair of
mirror-image multi-level stabilization assemblies (195) would be a
desirable implantation choice.
[0069] FIG. 8 shows a lateral stabilization device (200) having an
upper attachment arm (202a) attached to a superior vertebral body
(100) by one or more fasteners, e.g., screws (204), and a lower
attachment arm (202b) attached to an inferior vertebral body (102)
by one or more fasteners, such as screws (204). The device also
includes a stabilization member (206). The stabilization member
(206) may include a spring or springs, a damper, or other mechanism
that provides a desired stabilization function. The stabilization
member may comprise a structure such as the facet stabilization
member (170) described above in relation to FIGS. 6A to 7
above.
[0070] Our lateral stabilization device (200) may be attached to
the lateral surfaces of two adjacent vertebral bodies (100, 102).
For assurance of balanced response to spine motion, a pair of
lateral stabilization devices (200) may be attached, one on each
lateral side of the pair of vertebral bodies.
[0071] FIG. 9A shows a pair of adjacent vertebral bodies (100, 102)
having both a posterior stabilization device (210) and an anterior
stabilization device (220) attached to each of the pair of
vertebral bodies. The posterior stabilization device (210) includes
a pair of studs or pedicle screws (212), one attached to each of
the superior vertebral body (100) and to the inferior vertebral
body (102). A stabilization member (214) extends between and
interconnects the pair of pedicle screws (212). The stabilization
member (214) may comprise a load bearing dynamic structure
comprising a spring or springs, one or more dampers (damping in
either or both axial directions), or any combination of such
structures. The anterior stabilization device (220) includes an
anterior element (222), shown in isolation in FIG. 9B. The anterior
element (222) may comprise a material having superelastic
properties, e.g., nitinol or the like. It may be of a shape that
allows the anterior element (222) to be constrained for a minimally
invasive implantation procedure.
[0072] As shown, the anterior element (222) includes an attachment
hole (224) at each end, and a central portion (226) that includes a
pair of side bands (228a, 228b) that define a central aperture
(230). The anterior element (222) may be rolled or compressed into
a low profile contracted state for implantation. Once introduced,
the anterior element is partially released from the contracted
state and attached to the pair of vertebral bodies (100, 102)
adjacent to the damaged disc (108). The anterior element (222) may
be attached by fasteners, such as screws or other suitable
mechanisms. Once attached, the anterior element (222) is fully
extended to its operative state and is capable of bearing loads to
stabilize the vertebral segments.
[0073] The anterior stabilization device (220) may be used alone,
in combination with the posterior stabilization device (210)
illustrated in FIG. 9A, or in combination with any other suitable
stabilization device or structure. By using a combination of
stabilization devices, the amounts and types of stabilization and
unloading of the vertebral segment may be tailored to suit a
specific clinical situation in a way that may be may not be readily
possible using a single stabilization structure.
[0074] FIGS. 10A-10F show several variations of a posterior dynamic
stabilization system made up, in general, of a posterior spacer and
one or more restrictor bands. As explained below, the spacer may be
integrated with the restrictor bands, or it may be provided
independently of the restrictor bands.
[0075] FIG. 10A shows a posterior spacer (240) that is generally in
the shape of a short cylinder or bead, having a central
through-hole (242) and an upper surface (244) and lower surface
(246). The posterior spacer (240) may be designed in other forms or
shapes, as is described more fully below. The spacer (240) may
comprise a generally compliant biocompatible material, e.g.,
polymeric materials such as polyurethanes, silicones, TPE's, and
other elastomers, or other suitable polymeric material. As shown in
the posterior view found in FIGS. 10B, 10D, and 10F, the spacer
(240) is placed between the spinous processes (106) of a pair of
adjacent vertebral bodies (100, 102). The spacer (240) maintains
the spacing between the vertebral bodies while allowing a desired
amount of relative motion between the two vertebral bodies.
[0076] The restrictor band (250) may be a continuous loop and may
comprise a relatively elastic biocompatible material, such as any
number of elastomeric and/or polymeric materials suitable for the
purpose. Should a constrained motion be desired, the loops may be a
comparatively inelastic material, e.g., nitinol or other such
biocompatible alloys. The restrictor bands (250) are linked to the
posterior spine to provide both stability and compliance. The bands
(250) may be attached to the vertebra by suitable fasteners, e.g.,
attachment screws (252) or studs or the like.
[0077] FIGS. 10C and 10E show the spacer (240) and the routing of
the bands (250) through the center opening (242) in the spacer.
These drawings are provided to show that routing in isolation from
the spine; the same configuration is shown respectively in FIGS.
10B and 10D.
[0078] FIG. 10F shows attachment of the bands (250) by looping them
directly onto the spinous processes (106) of the pair of vertebral
bodies. The materials, sizes, structures, and routing of the
restrictor bands (250) may be chosen to tailor a desired type and
degree of constraint. For example, a routing pattern that is
oriented relatively more diagonally to the axis of the spine, as in
FIG. 10D, will provide more resistance to torsional movement than
will a routing pattern that is oriented more vertically, as is
shown in FIG. 10F.
[0079] FIG. 11 shows another variation of a dynamic spinal
stabilization device having the capability of being adjusted after
implantation. The illustrated spinal stabilization device (260)
includes an upper attachment member (262) and a lower attachment
member (264), for attachment to a superior vertebral body (100) and
an inferior vertebral body (102), respectively. The two attachment
members (262, 264) may be attached to the spinous processes (106)
of the respective vertebral bodies (100, 102), as shown, or
attached to the pedicles or to other suitable portions of the
vertebral bodies. The attachment members (262, 264) may utilize or
comprise screws, although other attachment members may be used as
desired or as suitable. The stabilization device (260) includes one
or more spring elements (266) that each extend between and
interconnect the upper attachment member (262) and the lower
attachment member (264). Each spring element (266) is may be formed
of a suitable biocompatible shape memory or superelastic material,
such as nitinol. If the proper alloy is chosen, e.g., by utilizing
nitinol having A.sub.t.gtoreq.100.degree. F., the shape and
properties of each spring element (266) may be altered after
implantation by heating the spring element, for example, using an
electric current. Obviously, in such a situation, the spring
elements may also be altered prior to implantation. The shape
memory material may be trained by a heating process to conform to a
predetermined shape upon being heated to a predetermined
temperature. For example, leads may be placed in contact with the
spring elements (266) under X-ray or other guidance after
implantation in the spine of a patient. Electric current is then
supplied to the spring elements (266) through the leads, allowing
the user to alter the size, shape, or performance characteristics
of the spring elements.
[0080] Although the spring elements (266) shown in the embodiment
illustrated in FIG. 11 are depicted as generally straight struts,
the spring elements (266) may have other shapes, sizes, or
orientations suitable for a given application.
[0081] FIG. 12A is a schematic representation of another spinal
stabilization device that transfers loads from one segment of the
spine to adjacent segments. Three adjacent vertebral bodies (270,
272, 274) are shown schematically in the Figure. A pair of
interconnected stabilization devices (276) are attached to each of
the three vertebral bodies. In essence, the stabilization devices
(276) are elongate and fairly stiff but include shock absorption
and spring providing features in the linkages (280). Each depicted
stabilization device (276) includes three fixed rotatable elements
(278), each attached to a vertebral body through a bone fixation
device or member, e.g., a threaded stud or pedicle screw, and
includes a linkages (280) extending between and attached to each
adjacent pair of fixed rotatable elements (278).
[0082] Each of the fixed rotatable elements (278) comprises a
bearing structure (279 in FIG. 12D) or similar mechanism that
allows rotation of the attached linkage (280). The depicted bearing
structures (279) are often known as Heim joints. This allows a
first vertebral segment, such as vertebral body (270), to be loaded
in reaction to a load placed upon the adjacent vertebral segments,
such as vertebral bodies (272) and (274). As a non-limiting
example, when the lowest vertebral body (274) moves to the right,
as shown by arrow "A", the transfer of this load through rotation
of the fixation elements (278) imposing loading upon the attached
linkages (280) influences the upper vertebral body (270) to move to
the left, as shown by arrow "B". This movement is consistent with
the natural movement of the spine when the body twists. Compression
and flexion loads are transferred in a similar manner.
[0083] As noted above, each of the fixation elements (278) may
include a bearing or similar rotatable structure (279) that allows
rotational movement as represented by the arrows "C". This motion
transfer is seen from the side in schematic FIG. 12E and from the
top in FIG. 12F. The linkages (280) may comprise a compressible
element and spring element or elements having a size, shape, spring
constant, and other characteristics that provide the desired amount
of load transfer in response to rotation of the fixation elements
(278). In addition, although two stabilization devices (276) are
shown in the Figures, more or fewer devices may be used depending
upon the degree of stabilization needed or desired. The
stabilization devices (276) may also extend between more (e.g.,
four or more) or fewer (e.g., two) adjacent vertebral segments.
[0084] FIG. 13A shows a multi-component dynamic stabilization
system. Current dynamic spinal stabilization systems are typically
either interspinous devices (i.e., connected between the spinous
processes of adjacent vertebral bodies) or pedicle screw based
devices (i.e., connected between pedicle screws attached to the
pedicles of adjacent vertebral bodies). Each of these types of
dynamic stabilization devices functions by providing a distracting
force that unloads the disc (108). FIG. 13A shows an interspinous
stabilization system (290) connected to the spinous processes (106)
of a pair of adjacent vertebral bodies (100, 102), and a pair of
pedicle based stabilization systems (292a, 292b) (only one of the
pedicle based systems is shown in the Figure) attached by pedicle
screws to the pair of adjacent vertebral bodies (100, 102) on each
side of the spinous processes. Each of the pedicle based systems
(292a, 292b) comprises a spring loaded or other suitable structure
that provides a distracting force (arrows "D" in FIG. 13B), that
tends to unload the disc (108). The interspinous system (290), on
the other hand, includes a spring loaded or other suitable
structure that biases the spinous processes (106) of the adjacent
vertebral bodies (100, 102) toward one another, as represented by
arrows "E" in FIG. 13B. The combined action of the interspinous
system (290) and the pedicle based systems (292a, 292b) creates a
moment that relieves pressure from the disc (108).
[0085] The interspinous system (290) and the pedicle based systems
(292a, 292b) shown in FIGS. 13A and 13B may be constructed such
that one or more of the systems is externally adjustable, as
described, for example, below.
[0086] FIG. 14 shows a rear view of a pair of adjacent vertebral
bodies (100, 102) having dynamic stabilization devices (300)
attached to each of the vertebral bodies at a position at or near
the transverse processes (104a, 104b) of each vertebral body (100,
102). Each dynamic stabilization device (300) includes an upper
attachment screw (302) and a lower attachment screw (304). The
screws (302, 304) may be placed through the transverse process to
the vertebral body, or they may be attached directly to the
vertebral body adjacent the transverse process (104a, 104b). A
loading member (306) is attached to each of the upper attachment
screw (302) and the lower attachment screw (304) . . . . The
loading member (306) stabilizes the adjacent vertebral bodies by
providing an appropriate level of distraction or attraction forces.
The loading member (306) may comprise a spring, a set of springs, a
damping member, or any other suitable structure such as those
described elsewhere herein.
[0087] FIG. 15 provides a schematic illustration of an externally
adjustable dynamic stabilization system. The system includes an
upper screw (310) and lower screw (312) extending posteriorly from
an upper vertebral body (100) and a lower vertebral body (102),
respectively. Each screw extends outside of the patient's body. A
stabilization member (314) is attached to each of the screws (310,
312) on the external surface of the patient's back, i.e., outside
the surface of the skin (316). The stabilization member (314) may
include a spring or springs, dampers (damping in one axial
direction, the other direction, or both). The stabilization system
(316) may be adjusted post-operatively because it is located
externally of the patient without the need for additional surgical
intervention.
[0088] FIG. 16 is a schematic illustration of another adjustable
stabilization system. The spinal stabilization system (320)
includes an upper pot (322) attached to the spinous process (106)
of a superior vertebral body (100), and a lower pot (324) attached
to the spinous process (106) of an inferior vertebral body (102).
Each of the upper pot (322) and lower pot (324) forms a portion of
the attachment mechanism for the stabilization device. The upper
pot (322) and lower pot (324) may be attached to the spinous
processes (106) by any suitable mechanism, such as one or more
screws. Each of the upper pot (322) and lower pot (324) includes a
cylindrical portion that is adapted to receive a connector (326)
located at each of the upper end and lower end of a spring (328).
Each of the connectors (326) engages one of the upper pot (322) and
lower pot (324), thereby allowing the spring (328) to provide a
distracting force to the vertebral bodies (100, 102).
[0089] Because the upper pot (322) and lower pot (324) are
generally hollow, it is possible to partially fill one or both of
the pots (322, 324) to decrease the effective length of the spring
(328) extending between the pots, i.e., partially filling the pots
causes the connectors to engage the filler material at a level
removed from the bottom of the pot (322, 324). Either or both of
the pots (322, 324) may be partially filled with bone cement
containing polymethylmethacrylate (PMMA) or another suitable
material. The filling operation may be performed post-operatively
by way of a percutaneous access, thereby eliminating the need for
additional surgical intervention.
[0090] FIG. 17 is an illustration of another dynamic stabilization
system. The stabilization system (340) comprises a stabilizing disc
(344) and an "H" shaped intervertebral spacer (342) including a
DIAM.TM. type intervertebral spacer interposed between the spinous
processes (106) of a pair of adjacent vertebral bodies (100, 102).
DIAM.TM. type intervertebral spacers are commercially available and
are produced by Medtronic Sofamor Danek. The spacer (342) is
generally "H" shaped, including a relatively narrow center section
located between relatively wider side sections. This shape allows
the spacer (342) to be effectively inserted between the spinous
processes (106) of a pair of adjacent vertebral bodies (100, 102),
as shown in FIG. 17. The spacer (342) is a silicone device covered
with polyethylene, and functions by reducing loading of the disc,
restoring the posterior tension band, realigning the facets, and
restoring the foramenal height.
[0091] In addition, a stabilizing disc (344) is interposed between
the spinous processes (106) in place of a portion of the spacer
(340). The stabilizing disc (344) has a structure and is
constructed in a manner identical to the facet stabilizing member
(170) described above in relation to FIG. 5, having a core member
located between a pair of endplates. The stabilizing disc (344)
allows for compression and rotation, if needed. The stabilizing
disc (344) also facilitates lateral bending.
[0092] As noted above, this application incorporates by reference
U.S. Provisional Patent Application Ser. No. 60/713,671, entitled
"Prosthetic Intervertebral Discs," ("the '671 application"), which
was filed Sep. 1, 2005, and which is assigned to Spinal Kinetics,
Inc., the assignee of the present application. The '671 application
describes, inter alias, spinal treatment methods that combine a
prosthetic intervertebral disc with a dynamic stabilization system.
Each of the dynamic stabilization systems described in the present
application are suitable for use in combination with prosthetic
intervertebral discs such as those described in the '671
application, and others described in U.S. patent application Ser.
No. 10/903,276, filed Jul. 30, 2004, ("the '276 application"),
which is also incorporated by reference herein.
[0093] For example, an exemplary prosthetic intervertebral disc
(1100) is shown in FIG. 18, which is reproduced from FIG. 3 of the
'671 application and which was also described in the '276
application. This prosthetic disc is described for exemplary
purposes, and is not intended to represent the only type of
prosthetic disc that is suitable for use in combination with the
devices and systems described elsewhere herein. Turning to FIG. 18,
the prosthetic disc (1100) has an integrated structure that
includes an upper endplate (1110), a lower endplate (1120), and a
core member (1130) retained between the upper endplate (1110) and
the lower endplate (1120). One or more fibers (1140) are wound
around the upper and lower endplates to attach the endplates to one
another. The wind of the fibers (1140) allows a degree of axial
rotation, bending, flexion, and extension by and between the
endplates. An annular capsule (1150) is optionally provided in the
space between the upper and lower endplates, surrounding the core
member (1130) and the fibers (1140). The upper endplate (1110) and
lower endplate (1120) are generally flat, planar members, and are
fabricated from a biocompatible material that provides substantial
rigidity.
[0094] The upper surface of the upper endplate (1110) and the lower
surface of the lower endplate (1120) are preferably each provided
with a mechanism for securing the endplate to the respective
opposed surfaces of the upper and lower vertebral bodies between
which the prosthetic disc is to be installed. For example, in FIG.
18, the upper endplate (1110) includes a plurality of anchoring
fins (1111a, 1111b). The anchoring fins (1111a, 1111b are intended
to engage mating grooves that are formed on the surfaces of the
upper and lower vertebral bodies to thereby secure the endplate to
its respective vertebral body. The anchoring fins (1111a, 1111b)
extend generally perpendicularly from the generally planar external
surface of the upper endplate (1110), i.e., upward from the upper
side of the endplate as shown in FIG. 18. Each of the anchoring
fins (1111a, 1111b) has a plurality of serrations (1112) located on
the top edge of the anchoring fin. The serrations (1112) are
intended to enhance the ability of the anchoring fin to engage the
vertebral body and to thereby secure the upper endplate (1110) to
the spine.
[0095] Similarly, the lower surface of the lower endplate (1120)
includes a plurality of anchoring fins (1121a, 1111b). The
anchoring fins (1121a, 1111b) on the lower surface of the lower
endplate (1120) are identical in structure and function to the
anchoring fins (1111a, 1111b) on the upper surface of the upper
endplate (1110), with the exception of their location on the
prosthetic disc.
[0096] The anchoring fins (1111, 1121) may optionally be provided
with one or more holes or slots (1115, 1125). The holes or slots
help to promote bony ingrowth that assist in anchoring the
prosthetic disc (1100) to the vertebral bodies.
[0097] The upper endplate (1110) contains a plurality of slots
(1114) through which the fibers (1140) may be passed through or
wound, as shown. The actual number of slots (1114) contained on the
endplate is variable. The purpose of the fibers (1140) is to hold
the upper endplate (1110) and lower endplate (1120) together and to
limit the range-of-motion to mimic the range-of-motion and
torsional and flexural resistance of a natural disc.
[0098] The core member (1130) is intended to provide support to and
to maintain the relative spacing between the upper endplate (1110)
and lower endplate (1120). The core member (1130) is made of a
relatively compliant material, for example, polyurethane or
silicone, and is typically fabricated by injection molding. A
preferred construction for the core member includes a nucleus
formed of a hydrogel and an elastomer reinforced fiber annulus. The
shape of the core member (1130) is typically generally cylindrical
or bean-shaped, although the shape (as well as the materials making
up the core member and the core member size) may be varied to
obtain desired physical or performance properties. The core member
(1130) shape, size, and materials of construction will directly
affect the degree of flexion, extension, lateral bending, and axial
rotation of the prosthetic disc.
[0099] The annular capsule (1150) may be made of polyurethane or
silicone or hydrogel and may be fabricated by injection molding,
two-part component mixing, or dipping the endplate-core-fiber
assembly into a polymer solution. A function of the annular capsule
is to act as a barrier that keeps the disc materials (e.g., fiber
strands) within the body of the disc, and that keeps natural
in-growth outside the disc.
[0100] The foregoing prosthetic disc (1100), or other suitable
prosthetic discs, may be implanted by surgical techniques described
in the '671 and '276 applications and elsewhere. As described
above, it may be advantageous to combine the prosthetic
intervertebral disc with any of the devices, systems, and methods
described herein to obtain synergistic therapeutic results in
treatment of spinal disease, trauma, or other disorder.
Conventions
[0101] It is our intention that this description not be limited to
the particular described variations. It is also to be understood
that the terminology we use is solely for the purpose of describing
particulars of the devices and methods. We do not intend the
terminology to be limiting, since the scope of the present
invention will be limited only by the appended claims.
[0102] Where a range of values is provided, we intend our
description to specifically include each intervening value, to at
least the tenth of the unit of the lower range limit unless the
context clearly dictates otherwise, found between the upper and
lower range limits of that range and any other stated or
intervening value in that stated range.
[0103] Unless defined otherwise, we intend all technical and
scientific terms to have the same meaning as commonly understood by
one of ordinary skill in the art to which the described device and
methods belong. All publications mentioned herein are incorporated
herein by reference for the purpose of disclosing and describing
the methods and/or materials in connection with which the
publications are cited.
[0104] We intend that in this specification and in the appended
claims, the singular forms "a", "an," and "the" include plural
referents unless the context clearly dictates otherwise.
[0105] As will be apparent to those of skill in the art upon
reading this disclosure, each of the described device and method
has discrete components and features that may be readily separated
from or combined with the features of any of the other several
devices and methods.
[0106] It is to be understood that the described devices and
processes that are the subject of this patent application are not
limited to the particular described variations, as such may, of
course, vary. In particular, our description is meant to include
implanted or implantable combinations of two or more of the
specific devices described herein, to the extent that the devices
are compatible with one another.
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