U.S. patent application number 10/848691 was filed with the patent office on 2004-10-28 for superelastic spinal stabilization system and method.
Invention is credited to Justis, Jeff R., Sherman, Michael C..
Application Number | 20040215192 10/848691 |
Document ID | / |
Family ID | 24057718 |
Filed Date | 2004-10-28 |
United States Patent
Application |
20040215192 |
Kind Code |
A1 |
Justis, Jeff R. ; et
al. |
October 28, 2004 |
Superelastic spinal stabilization system and method
Abstract
An apparatus for treatment of the spine including a
stabilization device at least partially formed of a material
capable of exhibiting superelastic characteristics at about body
temperature. The stabilization device includes a longitudinal
portion positionable across at least one intervertebral space, a
first anchor portion engagable with a first vertebral body, and a
second anchor portion engagable with a second vertebral body. The
stabilization device is reformed from an initial configuration to a
different configuration in response to an imposition of stress
caused by relative displacement between the first and second
vertebral bodies.
Inventors: |
Justis, Jeff R.; (Cordova,
TN) ; Sherman, Michael C.; (Memphis, TN) |
Correspondence
Address: |
Woodard, Emhardt, Moriarty, McNett & Henry LLP
Bank One Center/Tower
111 Monument Circle, Suite 3700
Indianapolis
IN
46204-5137
US
|
Family ID: |
24057718 |
Appl. No.: |
10/848691 |
Filed: |
May 19, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10848691 |
May 19, 2004 |
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09960770 |
Sep 21, 2001 |
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6761719 |
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09960770 |
Sep 21, 2001 |
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09516946 |
Mar 1, 2000 |
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6293949 |
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Current U.S.
Class: |
606/257 ;
606/264; 606/277; 606/279; 606/283; 606/298; 606/299; 606/907;
606/910; 606/911 |
Current CPC
Class: |
A61F 2002/30092
20130101; A61B 17/70 20130101; A61B 17/7059 20130101; A61B
2017/00867 20130101; A61B 17/8042 20130101; A61F 2002/449 20130101;
Y10S 606/911 20130101; A61B 17/7011 20130101; Y10S 606/91 20130101;
A61F 2210/0014 20130101 |
Class at
Publication: |
606/061 |
International
Class: |
A61B 017/58 |
Claims
What is claimed is:
1. An apparatus for treatment of the spine, comprising: a
stabilization device at least partially formed of a material
capable of exhibiting superelastic characteristics at about body
temperature, said stabilization device comprising: a longitudinal
portion positionable across at least one intervertebral space; a
first anchor portion engagable with a first vertebral body; and a
second anchor portion engagable with a second vertebral body; and
wherein said stabilization device is reformed from an initial
configuration to a different configuration in response to an
imposition of stress caused by relative displacement between the
first and second vertebral bodies.
2. The apparatus of claim 1 wherein said material comprises a
shape-memory material.
3. The apparatus of claim 2 wherein said shape-memory material
comprises a polymer.
4. The apparatus of claim 2 wherein said shape-memory material
comprises a metallic alloy.
5. The apparatus of claim 1 wherein said imposition of stress
causes at least a portion of said material to form reversible
stress-induced martensite, and wherein a reduction of said stress
causes at least a portion of said material to reform into
austenite.
6. The apparatus of claim 5 wherein said stabilization device is
reformed from said different configuration back toward said initial
configuration in response to said reduction in said stress.
7. The apparatus of claim 1 wherein said material is in an
austenitic state when said stabilization device is in said initial
configuration and in a stress-induced martensitic state when said
stabilization device is in said different configuration.
8. The apparatus of claim 1 wherein said longitudinal portion has
an initial length corresponding to said initial configuration and a
different length corresponding to said different configuration.
9. The apparatus of claim 1 wherein said stabilization device has
an initial shape corresponding to said initial configuration and a
different shape corresponding to said different configuration.
10. The apparatus of claim 1 wherein said first and second anchor
portions extend transversely from said longitudinal portion.
11. The apparatus of claim 1 wherein said longitudinal portion
comprises a rod.
12. The apparatus of claim 1 wherein said longitudinal portion
comprises a plate.
13. The apparatus of claim 1 wherein said first and second anchor
portions comprise screws.
14. The apparatus of claim 1 wherein said first and second anchor
portions comprise hooks.
15. An apparatus for treatment of the spine, comprising: a
plurality of stabilization devices at least partially formed of a
material capable of exhibiting superelastic characteristics at
about body temperature, each of said stabilization devices
comprising: a longitudinal portion positionable across at least one
intervertebral space; a first anchor portion engagable with a first
vertebral body; and a second anchor portion engagable with a second
vertebral body; and wherein each of said stabilization devices is
reformed from an initial configuration to a different configuration
in response to an imposition of stress caused by relative
displacement between corresponding ones of the first and second
vertebral bodies.
16. The apparatus of claim 15 wherein said material comprises a
shape-memory material.
17. The apparatus of claim 15 wherein said imposition of stress
causes at least a portion of said material to form reversible
stress-induced martensite, and wherein a reduction of said stress
causes at least a portion of said material to reform into
austenite.
18. The apparatus of claim 15 wherein said material is in an
austenitic state when said stabilization device is in said initial
configuration and in a stress-induced martensitic state when said
stabilization device is in said different configuration.
19. The apparatus of claim 15 wherein each of said stabilization
devices has an initial shape corresponding to said initial
configuration and a different shape corresponding to said different
configuration.
20. A method for treatment of the spine, comprising: providing a
plurality of stabilization devices at least partially formed of a
material exhibiting superelastic characteristics at about body
temperature; and engaging each of the plurality of stabilization
devices to a corresponding pair of vertebral bodies.
21. The method of claim 20 further comprising transforming at least
a portion of the material into reversible stress-induced martensite
as a result of imposition of stress caused by relative movement
between the corresponding pair of vertebral bodies.
22. The method of claim 21 wherein the relative movement between
the corresponding pair of vertebral bodies comprises at least one
of flexional and extensional movement.
23. The method of claim 21 wherein the relative movement between
the corresponding pair of vertebral bodies comprises torsional
movement.
24. The method of claim 21 wherein the transforming is accompanied
by a corresponding change in length of the stabilization
device.
25. The method of claim 21 wherein the transforming is accompanied
by a corresponding change in shape of the stabilization device.
26. The method of claim 21 further comprising reforming at least a
portion of the reversible stress-induced martensite into austenite
by reducing the stress.
27. The method of claim 20 wherein the engaging comprises anchoring
the plurality of stabilization devices across multiple vertebral
levels.
28. The method of claim 20 wherein the engaging comprises anchoring
the plurality of stabilization devices to a cervical region of the
spine.
29. The method of claim 20 wherein the material comprises a
shape-memory material having a stress-induced martensitic state and
an unstressed austenitic state, the engaging occurring while the
shape-memory material is in the unstressed austenitic state.
30. The method of claim 20 wherein the plurality of stabilization
devices stabilize the portion of the spine being treated while
providing substantially normal biomechanical motion thereto.
Description
[0001] The present application is a continuation of pending U.S.
patent application Ser. No. 09/960,770, filed Sep. 21, 2001, which
is a continuation of U.S. patent application Ser. No. 09/516,946,
filed Mar. 1, 2000 and issued as U.S. Pat. No. 6,293,949, the
contents of each patent application hereby being incorporated by
reference in their entirety.
FIELD OF THE INVENTION
[0002] The present invention relates generally to the field of
instrumentation and systems for treatment of the spine, and more
particularly to a device for flexibly stabilizing the cervical
spine.
BACKGROUND OF THE INVENTION
[0003] As with any bony structure, the spine is subject to various
pathologies that compromise its load bearing and support
capabilities. Such pathologies of the spine include, for example,
degenerative diseases, the effects of tumors and, of course,
fractures and dislocations attributable to physical trauma. In the
treatment of diseases, malformations or injuries affecting spinal
motion segments (which include two adjacent vertebrae and the disc
tissue or disc space therebetween), and especially those affecting
disc tissue, it has long been known to remove some or all of a
degenerated, ruptured or otherwise failing disc. In cases in which
intervertebral disc tissue is removed or is otherwise absent from a
spinal motion segment, corrective measures are indicated to insure
the proper spacing of adjacent vertebrae formerly separated by the
removed disc tissue.
[0004] Commonly, the adjacent vertebrae are fused together using a
graft structure formed of transplanted bone tissue, an artificial
fusion element, or other suitable compositions. Elongated rigid
plates have been helpful in the stabilization and fixation of the
spine when used alone or in conjunction with a grafting procedure,
especially in the thoracic and lumbar regions of the spine. These
plating systems also have the potential advantage of increasing
union rates, decreasing graft collapse, minimizing subsequent
kyphotic deformity, and decreasing the need for bulky or rigid
postoperative immobilization. Additionally, rigid internal fixation
systems may improve the overall quality of life of the patient and
may provide the opportunity for earlier rehabilitation.
[0005] The plating techniques described above have also found some
level of acceptance by surgeons specializing in the treatment of
the cervical spine. The cervical spine can be approached either
anteriorly or posteriorly, depending upon the spinal disorder or
pathology to be treated. Many well-known surgical exposure and
fusion techniques of the cervical spine are described in the
publication entitled Spinal Instrumentation, edited by Drs. Howard
An and Jerome Cotler. The primary focus of cervical plating systems
has been to restore stability and increase the stiffness of an
unstable spinal motion segment. During the development of cervical
plating systems, various needs have been recognized. For example,
the system should provide strong mechanical fixation that can
control movement of the vertebral segments. The system should also
be able to maintain stress levels below the endurance limits of the
plate material, while at the same time exceeding the strength of
the anatomic structures or vertebrae to which the plating system is
engaged. Additionally, the system should preferably be capable of
accommodating for the natural movement of the vertebrae relative to
one another, including torsional movement during rotation of the
spine and translational movement during flexion or extension of the
spine.
[0006] There is increased concern in the spinal medical community
that anterior or posterior plating systems may place excessive
loads on the vertebrae or graft structure in response to small
degrees of spinal motion. See, e.g., K. T. Foley, D. J. DiAngelo,
Y. R. Rampersaud, K. A. Vossel and T. H. Jansen, The In Vitro
Effects of Instrumentation on Multi-level Cervical Strut-Graft
Mechanics, 26.sup.th Proceeding of the Cervical Spine Research
Society, 1998. If the plating system is used in conjunction with
grafting, these loads may promote pistoning, which can ultimately
lead to degradation or failure of the graft construct.
Additionally, even small degrees of spinal motion can cause
significant forces to be placed on the spinal plate and the bone
anchor devices which attach the plate to the vertebrae, whether
they be bone screws, hooks, etc. These forces may lead to failure
of the plate or loosening of the points of attachment between the
bone anchors and the vertebrae, thus resulting in the potential
loss of support by the plate.
[0007] Thus, there is a general need in the industry to provide an
apparatus and method for treatment of the spine. The present
invention meets this need and provides other benefits and
advantages in a novel and unobvious manner.
SUMMARY OF THE INVENTION
[0008] The present invention relates generally to an apparatus and
method for treatment of the spine. While the actual nature of the
invention covered herein can only be determined with reference to
the claims appended hereto, certain forms of the invention that are
characteristic of the preferred embodiments disclosed herein are
described briefly as follows.
[0009] In one form of the present invention, an apparatus is
provided for treatment of the spine including a stabilization
device at least partially formed of a material exhibiting
superelastic characteristics at about body temperature. The
stabilization device includes a longitudinal portion positionable
across at least one intervertebral space, a first anchor portion
engagable with a first vertebral body, and a second anchor portion
engagable with a second vertebral body. The stabilization device is
reformed from an initial configuration to a different configuration
in response to an imposition of stress caused by relative
displacement between the first and second vertebral bodies.
[0010] In another form of the present invention, an apparatus is
provided for treatment of the spine including a plurality of
stabilization devices at least partially formed of a material
exhibiting superelastic characteristics at about body temperature.
The stabilization devices each include a longitudinal portion
positionable across at least one intervertebral space, a first
anchor portion engagable with a first vertebral body, and a second
anchor portion engagable with a second vertebral body. Each of the
stabilization devices is reformed from an initial configuration to
a different configuration in response to an imposition of stress
caused by relative displacement between corresponding ones of the
first and second vertebral bodies.
[0011] In another form of the present invention, a method is
provided for treatment of the spine, including providing a
plurality of stabilization devices at least partially formed of a
material exhibiting superelastic characteristics at about body
temperature, and engaging each of the plurality of stabilization
devices to a corresponding pair of vertebral bodies.
[0012] It is one object of the present invention to provide an
apparatus and method for treatment of the spine.
[0013] Further objects, features, advantages, benefits, and aspects
of the present invention will become apparent from the drawings and
description contained herein.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] FIG. 1 is an anterior view of the cervical region of the
spine showing a spinal stabilization system according to one
embodiment of the present invention attached to two cervical
vertebrae.
[0015] FIG. 2 is a partial cross-sectional view of the spinal
stabilization system depicted in FIG. 1, with the screws disposed
through holes in the stabilization plate and engaged to a cervical
vertebra.
[0016] FIG. 3 is a side perspective view of the spinal
stabilization system depicted in FIG. 1.
[0017] FIG. 4a is a top view of a stabilization plate according to
an embodiment of the present invention, shown in an unstressed
configuration.
[0018] FIG. 4b is a top view of the stabilization plate depicted in
FIG. 4a, shown in a stressed configuration.
[0019] FIG. 5 is a side elevation view of the stabilization plate
depicted in FIG. 4a.
[0020] FIG. 6 is an end elevation view of the stabilization plate
depicted in FIG. 4a.
[0021] FIG. 7 is an angled cross-sectional view of the
stabilization plate depicted in FIG. 4a, taken along line 7--7 of
FIG. 4a.
[0022] FIG. 8 is a side elevation view of a bone screw according to
one aspect of the present invention.
[0023] FIG. 9 is a side elevation view of a locking fastener
according to another aspect of the present invention.
[0024] FIG. 10 is a top view of a stabilization plate according to
another embodiment of the present invention.
[0025] FIG. 11a is a side elevation view of the stabilization plate
depicted in FIG. 10, shown in an unstressed configuration.
[0026] FIG. 11b is a side elevation view of the stabilization plate
depicted in FIG. 10, shown in a stressed configuration.
[0027] FIG. 12 is a posterior view of the thoracic region of the
spine showing a spinal stabilization system according to another
embodiment of the present invention attached to three
vertebrae.
[0028] FIG. 13a is a side elevation view of the stabilization rod
depicted in FIG. 12, shown in an unstressed configuration.
[0029] FIG. 13b is a side elevation view of the stabilization rod
depicted in FIG. 12, shown in a stressed configuration.
DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS
[0030] For the purposes of promoting an understanding of the
principles of the invention, reference will now be made to the
embodiments illustrated in the drawings and specific language will
be used to describe the same. It will nevertheless be understood
that no limitation of the scope of the invention is hereby
intended, such alterations and further modifications in the
illustrated devices, and such further applications of the
principles of the invention as illustrated herein being
contemplated as would normally occur to one skilled in the art to
which the invention relates.
[0031] FIGS. 1-2 depict a spinal stabilization system 20 according
to one embodiment of the present invention for stabilizing at least
a portion of the vertebral column. Stabilization system 20 is shown
attached to the cervical region of the vertebral column, extending
across a plurality of spinal motion segments, such as cervical
vertebrae V. However, it should be understood that system 20 may
also be utilized in other areas of the spine, such as the thoracic,
lumbar, lumbo sacral and sacral regions of the spine. It should
also be understood that system 20 can extend across any number of
vertebrae V, including two adjacent vertebrae V. Additionally,
although system 20 is shown as having application in an anterior
approach, system 20 may alternatively be applied in other surgical
approaches, such as, for example, a posterior approach.
[0032] In a typical grafting procedure, one or more adjacent pairs
of vertebra V may be fused together by way of a graft or implant
(not shown) positioned in the disc space between the adjacent
vertebrae V. The implant may be a bone graft, an artificial fusion
device, or any other type of interbody device that is insertable
into the disc space to promote fusion between the adjacent
vertebrae V. One purpose of the stabilization system 20 is to
prevent excessive loads from being placed on the graft structures
in response to even small degrees of spinal motion. However, it
should be understood that stabilization system 20 can be used in
conjunction with fusion or non-fusion treatment of the spine.
[0033] In accordance with the present invention, stabilization
system 20 includes an elongate member 22 positioned along a portion
of the vertebral column. In the illustrated embodiment, the
longitudinal member is an elongated stabilization plate sized to
span a distance between at least two vertebrae V. Although elongate
member 22 has been illustrated and described as a spinal plate, it
should be understood that elongate member 22 can also be configured
as a spinal rod 302 (FIG. 12) or any other type of longitudinal
element for use in conjunction with a spinal fixation system. It
should also be understood that any number of plates 22 or rods 302,
including a pair of plates 22 or a pair of rods 302 positioned on
opposite sides of the spine, could be used to provide stabilization
to the vertebral column. Stabilization plate 22 is secured to the
upper and lower vertebrae V.sub.U, V.sub.L (FIG. 1) by a plurality
of bone anchors, shown in the form of bone screws 24. However,
other types of bone anchors are also contemplated, such as, for
example, spinal hooks 304 (FIG. 12). A locking device 26 engages
the adjacent bone screws 24 to prevent bone screws 24 from
loosening and backing out. In the illustrated embodiment, the
locking device 26 is a screw extending through each end portion of
the plate 22 and into engagement with the heads of adjacent bone
screws 24. However, other types of locking devices are also
contemplated, such as, for example, a pop rivet, a retainer
fabricated from a shape-memory alloy configured to change shape in
response to a change in temperature or the release of stress, a
locking washer rotatably displaceable between an unlocked position
and a locked position, or any other type of locking mechanisms
known to those of skill in the art. An example of a locking washer
for use with the present invention is disclosed in U.S. patent
application Ser. No. 09/399,525 entitled "Anterior Cervical Plating
System" filed on Sep. 20, 1999, the contents of which are hereby
incorporated by reference. Further details regarding spinal
stabilization system 20 are described more fully below.
[0034] Referring to FIGS. 3-7, shown therein are various details
regarding the stabilization plate 22. Plate 22 has a longitudinal
axis L extending along its length and includes an elongated central
portion 30 and a pair of connection portions 32 disposed at
opposite ends of central portion 30. In the illustrated embodiment,
central portion 30 and connection portions 32 are formed integral
to plate 22, thus forming a unitary structure or construct.
However, it should be understood that connection portions 32 can be
formed separate from central portion 30 and attached thereto by any
method known to one of ordinary skill in the art, such as, for
example, by fastening or welding. Plate 22 is at least partially
formed of a shape-memory material that exhibits pseudoelastic
characteristics or behavior at about human body temperature, the
details of which will be discussed below. It should be understood
that the terms "pseudoelastic" and "superelastic" have identical
meanings and are used interchangeably throughout this document. In
one embodiment of the present invention, the entire plate 22 is
formed of the shape-memory material. However, it should be
understood that only central portion 30 need be at least partially
formed of the shape-memory material, with the connection portion 32
being formed of any suitable biocompatible material, such as, for
example, stainless steel or titanium.
[0035] SMAs exhibit a "shape-memory" characteristic or behavior in
which a particular component formed of a shape-memory alloy ("SMA")
is capable of being deformed from an initial "memorized" shape or
configuration to a different shape or configuration, and then
reformed back toward its initial shape or configuration. The
ability to possess shape-memory is a result of the fact that the
SMA undergoes a reversible transformation from an austenitic state
to a martensitic state. If this transformation occurs due to a
change in temperature, the shape-memory phenomena is commonly
referred to as thermoelastic martensitic transformation. However,
if the martensitic transformation occurs due to the imposition of
stress, the shape-memory phenomena is commonly referred to as
stress-induced martensitic transformation. The present invention is
primarily concerned with stress-induced martensitic
transformation.
[0036] SMAs are known to display a superelastic phenomena or
rubber-like behavior in which a strain attained beyond the elastic
limit of the SMA material during loading is recovered during
unloading. This superelastic phenomena occurs when stress is
applied to an SMA article at a temperature slightly higher than the
temperature at which the SMA begins to transform into austenite
(sometimes referred to as the transformation temperature or
A.sub.s). When stressed, the article first deforms elastically up
to the yield point of the SMA material (sometimes referred to as
the critical stress). However, upon the further imposition of
stress, the SMA material begins to transform into stress-induced
martensite or "SIM". This transformation takes place at essentially
constant stress, up to the point where the SMA material is
completely transformed into martensite. When the stress is removed,
the SMA material will revert back into austenite and the article
will return to its original, pre-programmed or memorized shape.
This phenomena is sometimes referred to as superelasticity or
pseudoelasticity. It should be understood that this phenomena can
occur without a corresponding change in temperature of the SMA
material. Further details regarding the superelastic phenomena and
additional characteristics of SIM are more fully described by
Yuichi Suzuki in an article entitled Shape Memory Effect and
Super-Elasticity in Ni--Ti Alloys, Titanium and Zirconium, Vol. 30,
No. 4, October 1982, the contents of which are hereby incorporated
by reference.
[0037] There is a wide variety of shape-memory materials suitable
for use with the present invention, including shape-memory metal
alloys (e.g., alloys of known metals, such as, for example, copper
and zinc, nickel and titanium, and silver and cadmium) and
shape-memory polymers. While there are many alloys which exhibit
shape-memory characteristics, one of the more common SMAs is an
alloy of nickel and titanium. One such alloy is nitinol, a
bio-compatible SMA formed of nickel and titanium. Nitinol is well
suited for the particular application of the present invention
because it can be programmed to undergo a stress-induced
martensitic transformation at about normal human body temperature
(i.e., at about 35-40 degrees Celsius). Moreover, nitinol has a
very low corrosion rate and excellent wear resistance, thereby
providing an advantage when used as a support structure within the
human body. Additionally, implant studies in animals have shown
minimal elevations of nickel in the tissues in contact with the
nitinol material. It should be understood, however, that other SMA
materials that exhibit superelastic characteristics are
contemplated as being within the scope of the invention.
[0038] The central portion 30 of plate 22 is at least partially
formed of an SMA material and has an initial or "memorized" shape
or configuration (see FIG. 4a), and a different shape or
configuration (FIG. 4b) when deformed through the imposition of
stress onto plate 22. If the central portion 30 is reshaped or
deformed while at a temperature above the transformation
temperature A.sub.s, the central portion 30 will automatically
recover toward its initial shape or configuration when the stress
is removed from plate 22. In one embodiment of the present
invention, the plate 22 is secured to the upper and lower vertebrae
V.sub.u, V.sub.l while in a substantially unstressed initial
configuration where virtually all of the SMA material is in an
austenitic state. Upon the imposition of stress onto plate 22,
caused by relative movement between the upper and lower vertebrae
V.sub.u, V.sub.l, at least a portion of the SMA material is
transformed into reversible stress-induced martensite. Upon the
reduction or removal of stress, at least a portion of the SMA
material is transformed back into austenite. It should be
understood that the plate 22 may be pre-stressed prior to being
secured to the upper and lower vertebrae V.sub.u, V.sub.l, thus
initially transforming a portion of the SMA material from
austentite into SIM. In this case, the SMA material will never
attain an entirely austenitic state when the stress imposed onto
plate 22 by the upper and lower vertebrae Vu, Vl is removed.
[0039] Referring specifically to FIG. 4a, central portion 30 is
shown in an initial, unstressed configuration. Central portion 30
has an accordion-like shape, defining a series of alternating
ridges 34 and grooves 36 extending along longitudinal axis L and
facing laterally outward relative to longitudinal axis L. When in
its initial configuration, central portion 30 has an initial,
unstressed length l.sub.1. Preferably, each of the alternating
ridges 34 and grooves 36 has a substantially triangular shape, with
the outermost tip 35 of ridges 34 being rounded to avoid trauma to
adjacent tissue, and the innermost portion of grooves 36 defining a
partially cylindrical surface 37. However, it should be understood
that ridges 34 and grooves 36 can take on other shapes as well,
such as, for example, an arcuate shape, an undulating curve shape,
or a square or rectangular shape. When central portion 30 is in its
initial configuration, each of the ridges 34 and grooves 36 have an
initial amplitude a.sub.l, as measured from base line B to the
outermost tip 35 and the innermost point of cylindrical surface 37.
Preferably, the partially cylindrical surface 37 has a diameter
somewhat larger than the minimum distance between adjacent ridges
34.
[0040] In the illustrated embodiment, a number of the alternating
ridges 34 and grooves 36 are defined along each of the laterally
facing sides 38a, 38b of central portion 30, with the ridges and
grooves defined along side 38a being disposed laterally opposite
respective ones of the ridges and grooves defined along side 38b,
thereby defining laterally opposing pairs of ridges 34.sub.p and
laterally opposing pairs of grooves 36.sub.p. A number of openings
or slots 40 extend through central portion 30 intermediate the
laterally opposing pairs of ridges 34.sub.p. Preferably, slots 40
have a substantially oval shape, with each of the slots 40 having
laterally extending side walls defining opposing concave surface 42
and an initial slot width w.sub.1 when central portion 30 is in its
initial, unstressed configuration. However, it should be understood
that slots 40 can take on other shapes as well, such as, for
example, circular, elliptical, diamond or other geometric shapes as
would occur to one of ordinary skill in the art. Slots 40 span
virtually the entire distance between the opposing pairs of ridges
34.sub.p, having opposing ends 44 positioned proximately adjacent
the outermost tips 35 of opposing pairs of ridges 34.sub.p. In a
preferred embodiment, the opposing ends 44 of slots 40 each define
a partially cylindrical surface 45. Preferably, the partially
cylindrical surface 45 has a diameter somewhat larger than the
minimum distance between the opposing concave surfaces 42. The
configuration of central portion 30 can alternatively be described
as having a pair of laterally opposing thin strips of material 46
extending along longitudinal axis L, each having a zig-zag or
corrugated shape and being linked together by a number of laterally
extending linking portions 48.
[0041] Referring now to FIG. 4b, central portion 30 is shown
reformed from the initial shape or configuration illustrated in
FIG. 4a to a different, stressed shape or configuration, such
reformation occurring in response to the imposition of stress
caused by relative displacement between the upper and lower
vertebrae V.sub.u, V.sub.l (FIG. 1). This relative displacement can
arise through translational movement of upper and lower vertebrae
V.sub.u, V.sub.l, as occurring during either flexion or extension
of the spinal column, or through torsional movement, as occurring
during rotation of the spinal column. The imposition of stress onto
central portion 30 causes at least a portion of the shape-memory
material to transform into reversible stress-induced martensite.
When deformed into its different configuration, central portion 30
has a different, stressed length l.sub.2, ridges 34 and grooves 36
have a different amplitude a.sub.2, and slots 40 are reshaped to
define a different slot width w.sub.2. In the illustrated
embodiment, central portion 30 is elongated or lengthened when
stressed, thus increasing length l.sub.2 and slot width w.sub.2
while decreasing the amplitude a.sub.2. However, it should be
understood that central portion 30 could alternatively be
compressed or shortened when stressed, thus decreasing length
l.sub.2 and slot width w.sub.2 while increasing the amplitude
a.sub.2.
[0042] Referring collectively to FIGS. 4a and 7, shown therein are
various details regarding the connection portions 32. Each of the
connection portions 32 has an inner surface 50 and an oppositely
facing outer surface 52. When plate 22 is secured to the spinal
column (FIGS. 1 and 2), the inner surface 50 abuts the upper and
lower vertebrae V.sub.u, V.sub.l. Inner surface 50 defines a
concave lateral curvature C (FIG. 6) extending along the
longitudinal axis L. Lateral curvature C preferably corresponds to
the anatomical curvature of the anterior, outer surfaces of upper
and lower vertebrae V.sub.u, V.sub.l. Outer surface 52 preferably
defines a convex surface extending along longitudinal axis L to
reduce the amount of trauma to the adjacent soft tissue when plate
22 is secured to the spinal column. Preferably, the central portion
30 of plate 22 defines a corresponding concave lateral curvature C
along inner surface 51 and a corresponding convex outer surface 53.
However, it should be understood that the central portion 30 and
the connection portions 32 can be individually configured to
accommodate the specific spinal anatomy and vertebral pathology
involved in any particular application of stabilization system
20.
[0043] Each of the connection portions 32 includes a pair of
openings 54 extending between the inner and outer surfaces 50, 52
along an axis 56 and configured to receive a respective one of the
bone screws 24 therein. In the illustrated embodiment, the axis 56
of openings 54 extends inwardly toward transverse axis T at an
angle .alpha..sub.1 (FIG. 7) and outwardly toward the end of
connection portion 32 at an angle .alpha..sub.2 (FIG. 5). In one
specific embodiment, angle a.sub.1 is approximately 6 degrees and
angle .alpha..sub.2 is approximately 12 degrees; however, other
angles .alpha..sub.1, .alpha..sub.2 are also contemplated as being
within the scope of the present invention. Preferably, openings 54
are identical in size and configuration, and are located
symmetrically about longitudinal axis L. However, it should be
understood that other sizes and configurations of openings 54 are
also contemplated and that a single opening 54 could alternatively
be defined in each of the connection portions 32. Each of the
openings 54 includes a cylindrical bore 58, extending through
connection portion 32 along axis 56 and opening onto the inner
surface 50. Openings 54 also include a partially spherical recess
60, extending from cylindrical bore 58 toward outer surface 52
along axis 56. Openings 54 additionally include a conical portion
62, extending between spherical recess 60 and outer surface 52
along axis 56. Preferably, conical portion 62 is flared outwardly
at approximately 45 degrees relative to axis 56.
[0044] Each of the connection portions 32 also includes a fastener
bore 66 extending between the inner and outer surfaces 50, 52 along
transverse axis T and preferably intersecting the longitudinal axis
L to thereby position fastener bore 66 intermediate and laterally
adjacent bone screw openings 54. Fastener bore 66 is adapted to
receive a respective one of the locking fasteners 26 therein.
Specifically, fastener bore 66 includes a threaded portion 68
opening onto the inner surface 50 and a conical portion 70
extending between the threaded portion 68 and the outer surface 52.
However, it should be understood that other configurations of
fastener bore 66 are also contemplated. For example, fastener bore
66 need not necessarily extend entirely through connection portion
32 in that threaded portion 68 can stop short of inner surface
50.
[0045] Referring to FIG. 8, shown therein are various details
regarding bone screw 24. Bone screw 24 includes a head portion 80
connected to a threaded shank portion 82 by an intermediate portion
84. Threaded shank portion 82 defines a number of threads 86
configured to engage vertebral bone and sized to pass through the
cylindrical bore 58 in connection portion 32. Threads 86 are
preferably cancellous threads, configured for engagement in the
cervical region of the spinal column. Additionally, threads 86 may
be configured to be self-tapping. Further, threads 86 preferably
define a constant outer diameter along the length of threaded
portion 82 approximately equal to the outer diameter of
intermediate portion 84, and a root diameter that tapers inwardly
toward the intermediate portion 84. However, it should be
understood that other configurations of threaded portion 82 are
also contemplated as would occur to one of ordinary skill in the
art.
[0046] The threads 86 gradually transition into intermediate
portion 84 by way of a thread run out 88. Intermediate portion 84
has an outer diameter sized somewhat larger than the diameter of
the cylindrical bore 58 in connection portion 32. Intermediate
portion 84 transitions into head portion 80 by way of a chamfer 90.
Head portion 80 includes a lower, partially spherical surface 92
configured to be substantially complementary to the partially
spherical recess 60 of opening 54. Head portion 80 also includes an
upper conical surface 94, connected to spherical surface 92 by a
flattened shoulder 96. In one embodiment, conical surface 94 is
flared inwardly relative to shoulder 96 at approximately 45
degrees. Head portion 80 further includes a truncated or flattened
upper surface 98, through which extends a tool receiving recess 100
configured to receive a driving tool therein (not shown). In one
embodiment, the tool recess 100 is a hexagonal recess; however,
other shapes are also contemplated as would occur to those skilled
in the art.
[0047] Referring to FIG. 9, shown therein are various details
regarding locking fastener 26. Locking fastener 26 includes a head
portion 110 and a threaded shank portion 112 extending therefrom.
Threaded shank portion 112 defines a number of machine threads 114,
configured to engage the threaded portion 68 of fastener bore 66 in
connection portion 32. Threaded shank portion 112 terminates in a
sharp point 116 to facilitate insertion of locking fastener 26 into
fastener bore 66 and to permit easier penetration into the upper
and lower vertebrae V.sub.u, V.sub.l. Threaded shank portion 112
transitions into head portion 110 by way of an outward taper 118.
Head portion 110 includes a lower, conical surface 120 configured
substantially complementary to the upper conical surface 94 of bone
screw 24. In one embodiment, conical surface 120 is flared
outwardly at approximately 45 degrees. Head portion 110 further
includes an upper surface 122, through which extends a tool
receiving recess 124 configured to receive a driving tool therein
(not shown). In one embodiment, the tool recess 124 is a
Phillips-type recess; however, other types are also contemplated as
would occur to those skilled in the art.
[0048] Referring once again to FIGS. 1 and 2, shown therein is
spinal stabilization system 20 securely attached to the upper and
lower vertebrae V.sub.u, V.sub.l. Initially, plate 22 is positioned
across at least two vertebrae V, with the inner surface 50 of the
connection portions 32 placed in abutment against an outer surface
of the upper and lower vertebrae V.sub.u, V.sub.l. The connection
portions 32 are then secured to the upper and lower vertebrae
V.sub.u, V.sub.l by passing bone screws 24 through openings 54 and
driving threaded portion 82 into vertebral bone by way of a driver
(not shown) inserted in tool receiving recess 100. The bone screws
24 continue to be driven into vertebral bone until the lower
spherical surface 92 of the head portion 80 is placed in abutment
against the upwardly facing spherical recess 60 of opening 54.
[0049] Conical portion 62 of openings 54 serves to facilitate the
insertion of bone screws 24 into openings 54. Further, the
interaction between spherical surface 92 and spherical recess 60
allows the bone screw 24 to be oriented relative to axis 56 within
a range of angles, limited by the interference between the
intermediate portion 84 of bone screw 24 and the cylindrical bore
58 in connection portion 32. Openings 54 act as a countersink for
the head portion 80 of bone screws 24, allowing a significant
portion of head portion 80 to be disposed beneath the upper surface
52 of connection portion 32 to thereby minimize the overall height
or profile of plate 22.
[0050] After the bone screws 24 are driven into the upper and lower
vertebrae V.sub.u, V.sub.l, thereby securely attaching plate 22
thereto, the locking fasteners 26 are then installed to prevent the
bone screws 24 from loosening and backing out. Specifically, the
threaded shank portion 112 of fastener 26 is engaged within the
threaded portion 68 of fastener bore 66 and threaded therethrough
by way of a driver (not shown) inserted in tool receiving recess
124. As the locking fastener 26 is driven through fastener bore 66,
point 116 pierces the vertebrae and the threaded portion 68 is
driven into vertebral bone, thereby further securing plate 22 to
upper and lower vertebrae V.sub.u, V.sub.l. Additionally, by
embedding threaded portion 68 in vertebral bone, the locking
fastener 26 is less likely to loosen and back out of fastener bore
66. The locking fastener 26 continues to be driven through the
fastener bore 66 until the lower conical surface 120 of head
portion 110 engages the upper conical surfaces 94 of the bone
screws 24. The abutment of locking fastener 26 against bone screws
24 serves to retain bone screws 24 within openings 54, thereby
preventing bone screws 24 from loosening and backing out. In an
alternative embodiment of the invention, a washer having a lower
conical surface may be disposed between the head portion 10 of
locking fastener 26 and the head portion 80 of bone screw 24.
Tightening the locking fastener 26 would cause the lower conical
surface of the washer to engage the upper conical surface 94 of
bone screws 24 to retain the bone screws 24 within the openings 54.
An example of such a washer is disclosed in U.S. patent application
Ser. No. 09/399,525 entitled "Anterior Cervical Plating System"
filed on Sep. 20, 1999, the contents of which have been
incorporated by reference.
[0051] Referring now to FIG. 10, therein is illustrated a
stabilization plate 200 according to another embodiment of the
present invention. Stabilization plate 200 extends along a
longitudinal axis L. Similar to plate 22, stabilization plate 200
is attached to upper and lower vertebrae V.sub.U, V.sub.L by way of
a plurality of bone screws 24, and a locking screw 26 that engages
the heads of adjacent bone screws 24 to prevent bone screws 24 from
loosening and backing out. Further details regarding plate 200 are
described more fully below. It should be understood that
stabilization plate 200 may be used in any application in which the
stabilization plate 22 is used, including those specific
applications discussed above.
[0052] Stabilization plate 200 includes an elongated central
portion 202 and a pair of connecting end portions 32 operably
attached to opposite ends of central portion 202, such as by
welding, fastening, or by any other method known to one of ordinary
skill in the art. However, it should be understood that central
portion 202 and connection portions 32 can be formed integral to
plate 200, thus forming a unitary structure or construct. Central
portion 202 is at least partially formed of a shape-memory material
that exhibits pseudoelastic characteristics or behavior at about
human body temperature. In one embodiment of the invention, the
entire plate 200 is formed of the shape-memory material. However,
it should be understood that only central portion 202 need be at
least partially formed of the shape-memory material, with the
connection portion 32 being formed of any suitable biocompatible
material, such as, for example, stainless steel or titanium.
[0053] The central portion 202 is at least partially formed of an
SMA, such as the SMA described above with regard to plate 22, and
has an initial or "memorized" shape or configuration (FIG. 11a),
and a different shape or configuration (FIG. 11b) when deformed
through the imposition of stress onto plate 200. If the central
portion 202 is reshaped or deformed while at a temperature above
the transformation temperature A.sub.s, the central portion 202
will automatically recover toward its initial shape or
configuration when the stress is removed from plate 200. In one
embodiment of the present invention, the plate 200 is secured to
the upper and lower vertebrae V.sub.u, V.sub.l while in a
substantially unstressed, initial configuration where virtually all
of the SMA material is in an austenitic state. Upon the imposition
of stress onto plate 200, caused by relative movement between the
upper and lower vertebrae V.sub.u, V.sub.l, at least a portion of
the SMA material is transformed into reversible stress-induced
martensite. Upon the reduction or removal of stress, at least a
portion of the SMA material is transformed back into austenite. It
should be understood that the plate 200 may be pre-stressed prior
to being secured to the upper and lower vertebrae V.sub.u, V.sub.l,
thus initially transforming a portion of the SMA material from
austenite into SIM. In this case, the SMA material will never
attain an entirely austenitic state when the stress imposed onto
plate 200 by the upper and lower vertebrae V.sub.u, V.sub.l is
removed.
[0054] Referring specifically to FIG. 11a, central portion 202 is
shown in an initial, unstressed configuration. Central portion 202
has a wavy, corrugated shape, defining a series of alternating
ridges 204 and grooves 206 extending along longitudinal axis L.
Preferably, each of the alternating ridges 204 and grooves 206 is
arcuate-shaped so as to form a series of undulating curves
extending along longitudinal axis L. Preferably, the ridges 204 and
grooves 206 form a sinusoidal pattern relative to the base line B.
However, it should be understood that the ridges 204 and grooves
206 can take on other shapes as well, such as, for example, a
triangular shape, thus forming a zig-zag pattern, or a square or
rectangular shape. When in its initial configuration, central
portion 202 has an initial, unstressed length l.sub.1, and each of
the ridges 204 and grooves 206 defines an initial amplitude
a.sub.1, as measured from base line B.
[0055] Referring now to FIG. 11b, central portion 202 is shown
reformed from the initial shape or configuration illustrated in
FIG. 11a to a different, stressed shape or configuration, such
reformation occurring in response to the imposition of stress
caused by relative displacement between the upper and lower
vertebrae V.sub.u, V.sub.l. This relative displacement can arise
through translational movement of upper and lower vertebrae
V.sub.u, V.sub.l, as occurring during either flexion or extension
of the spinal column, or through torsional movement, as occurring
during rotation of the spinal column. The imposition of stress onto
central portion 202 causes at least a portion of the shape-memory
material to transform into reversible stress-induced martensite.
When deformed into its different configuration, central portion 202
has a different, stressed length l.sub.2, and the ridges 204 and
grooves 206 have a different amplitude a.sub.2. In the illustrated
embodiment, central portion 202 is elongated or lengthened when
stressed, thus increasing length l.sub.2 while decreasing the
amplitude a.sub.2. However, it should be understood that the
central portion 202 could alternatively be compressed or shortened
when stressed, thus decreasing length l.sub.2 while increasing the
amplitude .alpha..sub.2.
[0056] Referring to FIG. 12, there is illustrated a stabilization
system 300 including a pair of spinal rods 302, each extending
along a longitudinal axis L and positioned along a portion of the
vertebral column on opposite sides of the spine. In the illustrated
embodiment, the spinal rods 302 are sized to span a distance
between at least two vertebrae V, such as upper and lower vertebrae
V.sub.u, V.sub.l. However, as discussed above with regard to system
20, it should be understood that stabilization system 300 may
extend across any number of vertebrae V, including two adjacent
vertebrae V. Additionally, although stabilization system 300 is
shown attached to the thoracic region of the spine, it should be
understood that system 300 may also be utilized in other areas of
the spine, such as the cervical, lumbar, lumbo sacral and sacral
regions of the spine. Furthermore, although system 300 is shown as
having application in a posterior approach, system 300 may
alternatively be applied in other surgical approaches, such as, for
example, an anterior approach.
[0057] Rods 302 are secured to the vertebrae V by a plurality of
bone anchors, shown in the form of spinal hooks 304. However, as
discussed above with regard to stabilization system 20, other types
of bone anchors are also contemplated, such as, for example, bone
screws. Anchoring of the hooks 304 to the vertebrae V and
connection of the hooks 304 to the spinal rods 302 are well known
to those of skill in the art, and therefore need not be discussed
in detail. Although rod 302 is illustrated as having a generally
circular configuration, it should be understood that other shapes
and configurations are also contemplated, such as, for example, an
elliptical, square, rectangular or polygonal configuration.
Additionally, although rods 302 are illustrated as having a
generally straight configuration, it should be understood that rods
302 may take on a curved configuration corresponding to the anatomy
of the spinal column.
[0058] Spinal rod 302 is at least partially formed of a
shape-memory material that exhibits pseudoelastic characteristics
or behavior at about human body temperature. In one embodiment of
the invention, the entire rod 302 is formed of a shape-memory
material. However, it should be understood that only a portion of
rod 302 need be at least partially formed of the shape-memory
material, with the remainder of rod 302 being formed of any
suitable biocompatible material. In one embodiment of the
invention, rod 302 is at least partially formed of an SMA, such as,
for example, nitinol. However, as discussed above with regard to
plate 22, other types of SMA materials are also contemplated as
falling within the scope of the invention, such as, for example,
other types of shape-memory metal alloys or shape-memory
polymers.
[0059] Each of the rods 302 has an initial or "memorized" shape or
configuration (FIG. 13a), and a different shape or configuration
(FIG. 13b) when deformed through the imposition of stress onto rod
302. If the rod 302 is reshaped or deformed while at a temperature
above the transformation temperature A.sub.s, the rod 302 will
automatically recover toward its initial shape or configuration
when the stress is removed. In one embodiment of the present
invention, the rod 302 is secured to the vertebrae V while in a
substantially unstressed, initial configuration, where virtually
all of the shape-memory material is in an austenitic state. Upon
the imposition of stress onto rod 302, caused by relative movement
between the vertebrae V at least a portion of the shape-memory
material will be transformed into reversible stress-induced
martensite. Upon the reduction or removal of stress, at least a
portion of the shape-memory material is transformed back into
austenite. It should be understood that rod 302 may be pre-stressed
prior to being secured to the vertebrae V, thus initially
transforming a portion of the shape-memory material from austenite
into SIM. In this case, the shape-memory material will never attain
an entirely austenitic state when the stress imposed onto rod 302
by the vertebrae V is removed.
[0060] Referring to FIG. 13a, rod 302 is shown in an initial,
unstressed configuration. When in its initial configuration, rod
302 has an initial, unstressed length l.sub.1. Referring to FIG.
13b, rod 302 is shown reformed from the initial shape or
configuration illustrated in FIG. 13a to a different, stressed
shape or configuration, such reformation occurring in response to
the imposition of stress caused by relative displacement between
the vertebrae V This relative displacement can arise through
translational movement of the vertebrae V, as occurring during
either flexion or extension of the spinal column, or through
torsional movement, as occurring during rotation of the spinal
column. The imposition of stress onto rod 302 causes at least a
portion of the shape-memory material to transform into reversible
stress-induced martensite. When deformed into its different
configuration, rod 302 has a different, stressed length l.sub.2. In
the illustrated embodiment, rod 302 is elongated or lengthened when
stressed, thus increasing the overall length of rod 302 from length
l.sub.1 to length l.sub.2. However, it should be understood that
rod 302 could alternatively be compressed or shortened when
stressed, thus decreasing the overall length of rod 302.
[0061] When secured to at least two vertebrae V, stabilization
plates 22 and 200 and rods 302 serve to stabilize at least a
portion of the spinal column, while allowing at least limited
relative displacement or movement between the vertebrae V to
restore substantially normal biomechanical function thereto. When
secured to the upper and lower vertebrae V.sub.u, V.sub.l and
stressed in response to relative movement between the upper and
lower vertebrae V.sub.u, V.sub.l, the plates 22, 200 and rods 302
will be reformed from their initial shape or configuration to a
different shape or configuration, and at least a portion of the
shape-memory material will be transformed from austenite to
stress-induced martensite. When in a stress-induced martensitic
state, the plates 22, 200 and rods 302 exert a substantially
constant restorative force onto the upper and lower vertebrae
V.sub.u, V.sub.l, thereby providing flexible stabilization to the
vertebral column, and in particular the cervical region of the
spine. Because the plates 22, 200 and rods 302 are at least
partially formed of a shape-memory material displaying superelastic
or pseudoelastic characteristics, when the stress exerted on plates
22, 200 and rods 302 is reduced or removed, at least a portion of
the shape-memory material will transform back into austenite, and
the plates 22, 200 and rods 302 will recover toward their initial,
memorized shape or configuration. Plates 22, 200 and rods 302 are
therefore compliant, capable of being repeatedly transformed
between an initial configuration and a different configuration
through the imposition and release of stress.
[0062] Because the central portions 30, 202 of plates 22, 200 and
at least a portion of rod 302 are at least partially formed of a
shape-memory material exhibiting pseudoelastic behavior, they are
capable of providing a relatively constant restorative forces to
the spinal column for correction of various spinal deformities.
This pseudoelastic behavior of the shape-memory material allows for
a relatively large degree of recoverable deflection or strain of
central portion 30, 202 of plates 20, 200 and at least a portion of
rod 302 than would be possible with conventional materials, such as
stainless steel or titanium. For instance, most conventional
materials are capable of being elastically deformed over a
relatively small range of deflection or strain, and when further
stressed begin to deform plastically. However, shape-memory
materials are capable of recovering up to about 8% of deflection or
strain, well beyond the yield point of conventional materials.
[0063] Moreover, because central portions 30, 202 are each
configured to define a number of alternating ridges and grooves
along the longitudinal axis L of plates 22, 200, when stress is
applied, a greater degree of flexation or deflection is possible
than with conventional plates having a flat or rectilinear
configuration. The spring-like configuration of central portions
30, 202 allows for this added degree of flexibility or
compliability. When central portions 30, 202 are in an initial
configuration, each has an initial length and the alternating
ridges and grooves have an initial amplitude. However, when stress
is applied to plates 22, 200 along the longitudinal axis L, central
portions 30, 202 will each be reformed to a different configuration
defining a different length and amplitude. When the stress is
removed, the spring-like action of the central portions 30, 202
will cause each of central portions 30, 202 to recover toward their
initial configuration, length and amplitude. By combining the
pseudoelastic characteristics of the shape-memory material with the
spring-like configuration of central portions 30, 202, greater
degrees of flexation or deflection are possible with stabilization
system 20 than are currently possible through existing systems.
[0064] While the invention has been illustrated and described in
detail in the drawings and foregoing description, the same is to be
considered as illustrative and not restrictive in character, it
being understood that only the preferred embodiments have been
shown and described and that all changes and modifications that
come within the spirit of the invention are desired to be
protected. For example, although the systems 20, 300 have been
illustrated and described as a spinal stabilization system, it
should be understood that plates 22, 200 and rods 302 can also be
used as a connector for connecting a first member to a second
member, and need not necessarily be used in conjunction with
treatment of the spinal column.
* * * * *