U.S. patent application number 13/048496 was filed with the patent office on 2011-07-07 for posterior dynamic stabilization of spine.
This patent application is currently assigned to ZIMMER SPINE, INC.. Invention is credited to JOHN J. GRABOWSKI, HUGH D. HESTAD, MIKE E. LANCIAL, SCOTT C. LYNCH, JULIE OSTERBERG, JOHN F. OTTE.
Application Number | 20110166605 13/048496 |
Document ID | / |
Family ID | 38256774 |
Filed Date | 2011-07-07 |
United States Patent
Application |
20110166605 |
Kind Code |
A1 |
HESTAD; HUGH D. ; et
al. |
July 7, 2011 |
POSTERIOR DYNAMIC STABILIZATION OF SPINE
Abstract
The present invention provides various interspinous vertebral
implants and methods for using the same for dynamic stabilization
of a spine. The interspinous vertebral implants of the present
invention comprise a resiliently compressible body that is adapted
for position between adjacent superior and inferior spinous
processes, and an anchoring member that is affixed to the superior
and the inferior spinous processes posterior to the resiliently
compressible body. The anchoring member provides a compressive
force while the resiliently compressible body provides a
distraction. Without being bound by any theory, it is believed that
the combination of the distraction and compressive forces created
by interspinous vertebral implants of the present invention result
in a rotational moment, which alleviates compression on the
intervertebral disk.
Inventors: |
HESTAD; HUGH D.; (EDINA,
MN) ; LANCIAL; MIKE E.; (ST. LOUIS PARK, MN) ;
OTTE; JOHN F.; (ST. ANTHONY, MN) ; LYNCH; SCOTT
C.; (PLYMOUTH, MN) ; GRABOWSKI; JOHN J.;
(BLOOMINGTON, MN) ; OSTERBERG; JULIE; (WACONIA,
MN) |
Assignee: |
ZIMMER SPINE, INC.
MINNEAPOLIS
MN
|
Family ID: |
38256774 |
Appl. No.: |
13/048496 |
Filed: |
March 15, 2011 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
11328393 |
Jan 9, 2006 |
7922745 |
|
|
13048496 |
|
|
|
|
Current U.S.
Class: |
606/279 |
Current CPC
Class: |
A61B 17/7053 20130101;
A61B 17/7062 20130101; A61B 17/7065 20130101; A61B 17/707
20130101 |
Class at
Publication: |
606/279 |
International
Class: |
A61B 17/88 20060101
A61B017/88 |
Claims
1. A method of stabilizing adjacent superior and inferior
vertebrae, each vertebra including a spinous process, the method
comprising: placing an interspinous vertebral implant between the
spinous process of the superior vertebra and the spinous process of
the inferior vertebra such that the interspinous vertebral implant
simultaneously exerts a compressive force on posterior portions of
the superior and inferior spinous processes while exerting opposing
distraction forces on anterior portions of the superior and
inferior spinous processes.
2. The method of claim 1, wherein the interspinous vertebral
implant includes a distraction member positioned between the
superior and inferior spinous processes exerting the opposing
distraction forces.
3. The method of claim 2, wherein the interspinous vertebral
implant includes a first anchoring member secured to the superior
spinous process and a second anchoring member secured to the
inferior spinous process.
4. The method of claim 3, wherein the first anchoring member is
secured to the superior spinous process posterior of the
distraction member.
5. The method of claim 4, wherein the second anchoring member is
secured to the inferior spinous process posterior of the
distraction member.
6. The method of claim 5, wherein the interspinous vertebral
implant provides a rotational moment to the superior and inferior
spinous processes relatively posterior to the distracting
member.
7. The method of claim 5, wherein the first and second anchoring
members are joined by a spring portion.
8. The method of claim 2, wherein the distraction member is a
compressible body contacting surfaces of each of the superior and
inferior spinous processes.
9. The method of claim 1, wherein the combination of the
distraction and compressive forces results in a reduction of
compressive forces on an intervertebral disk between the superior
and inferior vertebrae.
10. The method of claim 1, wherein simultaneously exerting a
compressive force on posterior portions of the superior and
inferior spinous processes while exerting opposing distraction
forces on anterior portions of the superior and inferior spinous
processes restores a normal curvature between the superior and
inferior vertebrae.
11. A method of dynamically stabilizing adjacent superior and
inferior vertebrae, each vertebra including a spinous process, the
method comprising: applying a distraction force to the spinous
processes of the superior and inferior vertebrae by placing a
compressible body between the spinous processes, wherein the
compressible body contacts a surface of each of the spinous
processes; and simultaneously providing a rotational moment to the
superior and inferior spinous processes at a location posterior to
the compressible body, thereby reducing the amount of compressive
force on an intervertebral disk between the superior and inferior
vertebrae.
12. The method of claim 11, wherein the rotational moment is
provided by securing first and second anchoring members to the
superior and the inferior spinous processes, respectively,
posterior to the compressible body.
13. The method of claim 12, wherein the first and second anchoring
members exert a compressive force on posterior portions of the
superior and inferior spinous processes.
14. The method of claim 12, wherein the first and second anchoring
members are joined by a spring portion.
15. The method of claim 14, wherein the spring portion is at least
partially enclosed in the compressible body.
16. The method of claim 15, wherein the compressible body comprises
an elastomeric material.
17. The method of claim 11, wherein providing a rotational moment
restores a normal curvature between the superior and inferior
vertebrae.
Description
REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 11/328,393, filed Jan. 9, 2006, which is
incorporated herein by reference.
FIELD OF THE INVENTION
[0002] The present invention relates to interspinous vertebral
implants and methods for using the same for dynamic stabilization
of the spine.
BACKGROUND OF THE INVENTION
[0003] Damage to an intervertebral disk typically results in
abnormal play of the vertebrae contiguous to this disk. This play
subjects the posterior articular processes to considerable
stresses, generating very painful wear and tear of these processes
and general instability of the spinal column. Such instability can
also result from an operation performed on a herniated
intervertebral disk, which entails access to the disk, thereby
weakening the ligament system of the articulation, or can result
from certain cases of arthrosis which also subjects the posterior
articulations to considerable and painful stresses.
[0004] Early implant devices for bracing the spinal column comprise
rigid elements which are connected to means of osseous anchoring.
The rigid elements frequently consist of metal rods which are
implanted along several vertebrae, on either side of the spinous
processes. These early devices had the disadvantage of being
difficult to implant, and necessitated considerable and complex
work in putting them into place. Moreover, they immobilized a
relatively long vertebral segment, which significantly reduced the
mobility of the patient and subjected the articulations situated on
either side of this rigid segment to considerable stresses which
often generated new pathological conditions.
[0005] Some recently developed interspinous stabilizers are
designed to be inserted between the spinous processes. For example,
one such stabilizer comprises an interspinous bearing cushion which
is fixed to the spinal column by a textile ligament which surrounds
the processes. One of the major disadvantages of the bearing
cushion is being relatively rigid and holding the vertebrae in a
specific position, thereby creating discomfort for the patient. In
addition, the bearing cushion tends to wear under the influence of
repeated stresses to which it is subjected.
[0006] Other relatively recent interspinous stabilizers have
anchoring members, which are adapted to be attached to processes,
directly perpendicular to a spring body that provides stability
during extension. These interspinous stabilizers, while helpful in
limiting the range of spinal motion during extension, lack
sufficient support in flexion and thus may create a flat back or
kyphotic positioning in the spine. Moreover, these interspinous
stabilizers may produce an undesirable load environment at adjacent
spine levels.
[0007] Therefore, there is a need for interspinous stabilizers that
can provide stability during both flexion and extension.
SUMMARY OF THE INVENTION
[0008] One aspect of the present invention provides methods and
devices for dynamically stabilizing adjacent vertebral bodies. In
one embodiment, methods of the present invention include inserting
a resiliently compressible body between adjacent superior and
inferior spinous processes, where the resiliently compressible body
contacts the respective surfaces of the spinous processes thereby
providing a distraction between the superior and inferior spinous
processes and affixing an anchoring member to the superior and
inferior spinous processes relatively posterior to the resiliently
compressible body thereby providing a rotational moment which
reduces the amount of compressive force in the anterior portion of
the vertebral body.
[0009] One aspect of the present invention provides an interspinous
vertebral implant that includes a distracting member comprising a
compressible body adapted for positioning between adjacent superior
and inferior spinous processes and an anchoring member that is
capable of applying compressive force, wherein said anchoring
member is capable of being anchored to the superior spinous process
and the inferior spinous process.
[0010] In one embodiment, the interspinous stabilizer of the
present invention comprises a resiliently compressible body that is
adapted to be inserted between adjacent superior and inferior
spinous processes. In this manner, the resiliently compressible
body contacts the respective surfaces of the spinous processes
thereby providing a distraction between the superior and inferior
spinous processes. The interspinous stabilizers also comprise an
anchoring member that can be used to affix the stabilizers to the
superior and inferior spinous processes relatively posterior to the
resiliently compressible body. Typically, the anchoring member also
provides a compressive force to the spinous processes. Without
being bound by any theory, it is believed that the combination of
the distraction and compressive forces results in creation of a
rotational moment that is believed to reduce the amount of
compressive force in the anterior portion of the vertebral body, in
particular on the intervertebral disk. Thus unlike other
conventional interspinous stabilizers, it is believed that the
interspinous stabilizers of the present invention reduce the amount
of compressive force on the intervertebral disk thereby providing a
significant relief to a patient.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] FIG. 1A is a side view of one embodiment of the interspinous
stabilizer of the present invention following implantation;
[0012] FIG. 1B is a perspective view of FIG. 1A;
[0013] FIG. 2A is a side view of another embodiment of the
interspinous stabilizer of the present invention following
implantation;
[0014] FIG. 2B is a plane view of FIG. 2A in the plane A-A showing
a method of anchoring the interspinous stabilizer shown in FIG.
2A;
[0015] FIG. 3A is a perspective view of another embodiment of the
interspinous stabilizer of the present invention;
[0016] FIG. 3B is a cross-sectional view of the interspinous
stabilizer of FIG. 3A;
[0017] FIGS. 4A and 4B are side views of another embodiment of the
interspinous stabilizer of the present invention with different
anchoring member shapes;
[0018] FIG. 5 is a side view of another embodiment of the
interspinous stabilizer of the present invention following
implantation;
[0019] FIG. 6 is a side view of another embodiment of the
interspinous stabilizer of the present invention following
implantation;
[0020] FIG. 7 is a side view of another embodiment of the
interspinous stabilizer of the present invention following
implantation;
[0021] FIG. 8A is a side view of another embodiment of the
interspinous stabilizer of the present invention following
implantation and at resting stage;
[0022] FIG. 8B is a side view of the interspinous stabilizer of
FIG. 8A at flexion;
[0023] FIGS. 9A and 9B are two different perspective views of
another embodiment of the interspinous stabilizer of the present
invention; and
[0024] FIG. 9C is a side view of the interspinous stabilizer of
FIGS. 9A and 9B following implantation.
DETAILED DESCRIPTION OF THE INVENTION
General Overview
[0025] The present invention provides implantable interspinous
stabilizers that provide a dynamic stability during flexion and
extension and methods for using the same. In particular, the
present invention provides methods and interspinous stabilizers
that provide a distraction force between the adjacent superior and
inferior spinous processes and a posterior compressive force on
these spinous processes. As used herein, "compressive force" refers
to a force that, in the absence of any counter force, will cause
two spinous processes to move closer to one another. And the terms
"distraction" or "distraction force" refers to a force that, in the
absence of any counter force, will cause two vertebral bodies to
move further apart from one another. Distraction of the adjacent
spinous processes is provided by placing a distraction member
between the adjacent superior and inferior spinous processes.
Typically, the distraction member comprises a resiliently
compressible body that can be deformed when compressed. The term
"resilient" has the conventional meaning known to one skilled in
the art, including having a characteristic of being capable of
withstanding a substantial amount of external force without being
permanently deformed and being able to revert back to substantially
its original shape when the external force is removed.
[0026] The interspinous stabilizers and methods of the present
invention prevent or reduce the incidence of a flat back or
kyphotic positioning in the spine by providing, in addition to
distraction, a compressive force on the adjacent spinous processes,
thereby at least partially counteracting the effect of distraction.
Such a compressive force is generally applied using at least one
anchoring element that is affixed to the spinous processes. The
anchoring element is typically affixed relatively posterior to the
location of the distractive member.
[0027] The anchoring element is adapted to exert a compressive
force on the superior spinous process and the inferior spinous
process that, in the absence of any counter force, will result in
bringing these two spinous processes closer to each other.
Combination of the distraction member and the compressive force
results in a rotational moment of vertebrae with the distraction
element being the center of the rotational moment. As used herein,
"rotational moment" refers to the force that is exerted to the
adjacent vertebrae such that a compressive force is exerted on the
spinous processes of the two vertebrae and a separation force is
exerted on the anterior portion of the two vertebrae, e.g.,
vertebral bodies. That is, the term refers to restoring lordosis,
i.e., force restoring the normal curvature of the spine. Without
being bound by any theory, it is believed that this rotational
moment exerts a separation force that, in the absence of any
counter force, will cause the anterior portion of the two vertebral
bodies to move further apart (or at least reduce the amount of
compressive force) from one another thereby providing at least a
partial relief from compression of the intervertebral disk,
especially on the anterior portion of the intervertebral disk.
[0028] The distraction element is adapted to be placed between
adjacent superior and inferior spinous processes and contacting the
respective surfaces of the spinous processes. Once implanted, the
distraction element stabilizes and provides additional support
during extension of the spine. During flexion, the compressive
force of the anchoring element increases as the amount of flexion
increases, thereby providing proportionally increasing counter
force to the amount of flexion. Accordingly, interspinous
stabilizers of the present invention provide a dynamic stability
during both flexion and extension.
Interspinous Stabilizers
[0029] The present invention will now be described with regard to
the accompanying drawings which assist in illustrating various
features of the invention. In this regard, the present invention
generally relates to interspinous stabilizers and methods for using
the same. That is, the invention relates to implants that are
intended to be inserted between the spinous processes of two
contiguous vertebrae.
[0030] Several different embodiments of the present invention
interspinous stabilizers are generally illustrated in the
accompanying FIGS. 1A through 9C, which are provided for the
purpose of merely illustrating the practice of the present
invention. It should be appreciated that these Figures are
presented only for illustrative purposes and do not constitute
limitations on the scope of the present invention.
[0031] Referring now to FIGS. 1A and 1B, in one particular
embodiment of the present invention the interspinous stabilizer 100
comprises a distraction element 110 and an anchoring element 120.
As can be seen, the anchoring element 120 is attached to the
spinous process 10 of two adjacent vertebrae 20 near the posterior
end of the spinous processes 10. The two arms 124 of the anchoring
element 120 extend anteriorly and posteriorly to engage the spinous
processes 10A and 10B. The two anchoring element arms 124 are
joined by a spring configuration 128. In FIGS. 1A and 1B, the
spring portion 128 that is connected to the anchoring element arms
124 is a coil spring configuration; however, it should be
appreciated that other spring configurations known to one skilled
in the art can also be used. The coil spring 128 is at least
partially enclosed or encapsulated within a resiliently
compressible body 114 to form the distraction element 110. The
overall shape of the distraction element 110 is not critical as
long as it can be inserted between two adjacent spinous processes
10 to provide a sufficient distraction necessary to stabilize the
spine. For example, the overall shape of the distraction element
110 can be rectangular, oblong, oval, etc. Typically, however, the
overall shape of the distraction element 110 in FIGS. 1A and 1B is
cylindrical.
[0032] The resiliently compressible body 114 can be made from any
suitable material known to one skilled in the art including, but
not limited to, elastomer, plastic, rubber, silicon, or a
combination thereof. Typically, the resiliently compressible body
is made from a material comprising an elastomeric material. It
should be appreciated, however, that regardless of the material
used, the outer surface of the resiliently compressible body 114 is
preferably biocompatible or non-immunogenic. While not shown in any
of the drawings, the resiliently compressible body 114 can
alternatively comprise a spring that is at least partially enclosed
or encapsulated within a non-elastomeric or an elastomeric
material. In this manner, the majority of resiliency is
attributable to the spring rather than the material itself.
[0033] The force of the anchoring element arms 124 is applied to
the spinous processes 10 posterior to the center of the coil spring
128 and the resiliently compressible body 114. The interspinous
stabilizer 100 is shown in FIGS. 1A and 1B with the anchoring
element 120 attached to the spinous processes 10 through a hole 30
in the spinous processes. In this particular embodiment, the
anchoring element 120 comprises two anchoring element arms 124 each
of which goes through the respective holes 30 in the spinous
processes 10 and hooks to the other side of the spinous processes
10. However, it should be appreciated that a variety of other
methods, such as a screw or nuts and bolts, known to one skilled in
the art can also be used to affix the anchoring element 120 to the
spinous processes 10.
[0034] The distraction element 110, comprising coil spring 128 and
the resiliently compressible body 114, provides distraction of the
spinous processes 10 on the anterior portion while the anchoring
element 120 through two arms 124 of the coil spring 128 is adapted
to provide compressive forces (as illustrated by the arrows 50) on
the posterior portion of the spinous processes 10. Without being
bound by any theory, it is believed that the compressive force
applied by the anchoring element 120 creates a lever or a
rotational moment while maintaining lordosis of the spine
section.
[0035] As stated above, a variety of other methods are known to one
skilled in the art for affixing the anchoring element 120 to the
spinous processes 10. FIGS. 2A and 2B illustrate one of the
alternative methods for affixing the anchoring element 120 to the
spinous processes 10. In this example, the anchoring element arms
124 are terminated with a U-shaped end 132. In affixing the
anchoring element 120 to the spinous processes 10, the U-shaped end
132 is used to hook the anchoring element arms 124 onto the spinous
processes 10. Once the U-shaped end 132 is hooked onto the edges of
the spinous process 10, the U-shaped end 132, which may be
malleable, can be crimped to the bone to provide a tighter linkage.
As shown in FIG. 2A, the width of the anchoring element arms 124
can be tapered such that the width of the anchoring element arm 124
near the U-shaped end 132 is wider than the width of the anchoring
element arm near the distraction element 110.
[0036] FIGS. 3A and 3B illustrate another distraction element. In
this illustration, the anchoring element 120 is similar to those
described above in reference to FIGS. 2A and 2B; however, it should
be appreciated that the U-shaped end 132 is not essential and other
configurations of the anchoring element 120 can be used to affix
the anchoring element 120 to the spinous processes 10. In FIGS. 3A
and 3B, the distraction element comprises coupled body unit 150
that is encompassed or encapsulated within a resiliently
compressible body 114. Typically, the resiliently compressible body
114 is made from a material comprising an elastomeric material. As
stated above, the shape of the distraction element is not important
as long as it is adapted to be placed between two adjacent spinous
processes 10, i.e., a superior and an inferior spinous process, 10A
and 10B, respectively. Typically, however, the distraction element
is cylindrical in shape.
[0037] The coupled body unit 150 comprises a first rigid piece 154A
and a second rigid piece 154B. The first rigid piece 154A comprises
a first coupling member 158A and a first anchoring member 136A.
Similarly, the second rigid piece 154B comprises a second coupling
member 158B and a second anchoring member 136B. Both of the first
anchoring member 136A and the second anchoring member 136B are
adapted to be affixed to the superior spinous processes 10, at a
location posterior to the distraction element 110, e.g., the
elastomeric body. As shown in FIG. 3B, when coupled together, the
first coupling member 158A and the second coupling member 158B are
adapted to rotate relative to each other.
[0038] The coupled body unit 150 can further comprise a spring or a
spring-like mechanism (not shown) within its body such that when
the first coupling member 158A and the second coupling member 158B
are rotated relative to each other, the rotation creates a
rotational moment that exerts a force to bring the first rigid
piece 154A and the second rigid piece 154B to its resting position.
The resting position of the first rigid piece 154A and the second
rigid piece 154B, relative to each other, can be parallel, i.e., in
the same plane and direction to one another as shown in FIG. 3A or
be parallel but the direction of the first rigid piece 154A and the
second rigid piece 154B can be at an angle relative to one another.
The degree of angle between the first rigid piece 154A and the
second rigid piece 154B can range anywhere between 0.degree.
(parallel and in the same direction) and 90.degree., preferably
0.degree. and 60.degree.. It should be appreciated, however, that
any angle necessary to affix the first rigid piece 154A and the
second rigid piece 154B to their respective spinous processes at a
resting or "natural" position of the spinous processes may be
used.
[0039] It should be appreciated that any method or device known in
the art of mechanical devices or one skilled in the art can be
utilized for coupling the first rigid piece 154A and the second
rigid piece 154B. Suitable coupling mechanisms include, but are not
limited to, a socket and a socket insert, as illustrated in FIG.
3B, and a ball and socket coupling mechanism. While FIG. 3B shows
the first coupling member 158A as a female part and the second
coupling member 158B as a male part, this configuration can be
switched.
[0040] In one illustrative example, a rotational moment is
generated between the first rigid piece 154A and the second rigid
piece 154B by using the elastomeric body (i.e., a resiliently
compressible body 114) to generate a spring-like action. For
example, in FIGS. 3A and 3B, the elastomeric body comprises two
radial slots 140 through which the first anchoring member 136A and
the second anchoring member 136B protrude. In FIG. 3A, the first
rigid piece 154A and the second rigid piece 154B are parallel to
one another in the same direction. When the first anchoring member
136A and the second anchoring member 136B are affixed to the
superior spinous process 10A and the inferior spinous process 10B,
respectively, (spinous processes are not shown in FIGS. 3A and 3B)
the elastomeric body becomes twisted (not shown), thereby creating
a spring-like action on the elastomeric body resulting in a
generation of a rotational moment on the first rigid piece 154A and
the second rigid piece 154B. In this case, the material used for
the elastomeric body should be such that it is able to generate a
sufficient rotational moment to be useful.
[0041] Another example of the interspinous stabilizer 100 of the
present invention is exemplified in FIGS. 4A and 4B. In this
example, the distraction element comprises a resiliently
compressible tri-lobular shaped body 400 (i.e., triangular in shape
with rounded edges thereby providing eccentric placement of arms).
The anchoring element comprises a resiliently stretchable anchoring
member 410. Preferably, the anchoring element is located posterior
to the mid-point of body 400. When implanted, the resiliently
stretchable anchoring member 410 is affixed or anchored to the
spinous processes 10. As the figures illustrate, the resiliently
stretchable anchoring member 410 is attached to a region that is
posterior to the mid-point or the center of the tri-lobular shaped
body 400. The interspinous stabilizer 100 of FIGS. 4A and 4B can be
constructed as a one piece unit, or it can be constructed as a two
or more piece unit in which a fastener or other fastening mechanism
420 is used to attach the resiliently stretchable anchoring member
410 to the resiliently compressible tri-lobular shaped body
400.
[0042] The interspinous stabilizer 100 of FIGS. 4A and 4B can also
include a fixation member (not shown) to attach the interspinous
stabilizer 100 to a pedicle (not shown). Suitable fixation members
are well known to one skilled in the art and include, but are not
limited to, a screw, a nut and bolt, or other mechanism suitable
for affixing or attaching the resiliently compressible tri-lobular
body 400 and/or the resiliently stretchable anchoring member 410 to
the pedicle. This fixation member (not shown) can be used in place
of or in addition to a fastener 420 to attach the anchoring member
410 to the resiliently compressible tri-lobular body 400 and/or the
pedicle (not shown).
[0043] FIG. 5 shows an interspinous stabilizer 100 having a
resiliently compressible body 114 that comprises a top end 500 and
a bottom end 504 that are adapted for contacting the surfaces of
superior spinous process 10A and inferior spinous process 10B,
respectively. The interspinous stabilizer 100 of FIG. 5 also
comprises a first non-elastic anchoring member 510, a second
non-elastic anchoring member 520, and a hinge 530 that operatively
joins the first non-elastic anchoring member 510 and the second
non-elastic anchoring member 520.
[0044] The first non-elastic anchoring member 510 comprises a first
anterior anchoring end 514 that is connected to the top end 500 of
the resiliently compressible body 114 and a first posterior
anchoring end 518 that is adapted for anchoring or affixing to the
inferior spinous process 10B posterior to the resiliently
compressible body 114. The second non-elastic anchoring member 520
comprises a second anterior anchoring end 524 that is connected to
the bottom end 504 of the resiliently compressible body 114 and a
second posterior anchoring end 528 that is adapted for anchoring or
affixing to the superior spinous process 10A posterior to the
resiliently compressible body 114. The hinge 530 joins the two
anchoring members 510 and 520 at a location between the anterior
anchoring ends and the posterior anchoring ends such that the first
and the second non-elastic anchoring members 510 and 520 form an
X-shape like configuration. As can be seen in FIG. 5, a distraction
force is supplied by a spacer (i.e., a resiliently compressible
body 114) between the top end 500 and the bottom end 504. This
results in a compressive force being applied at posterior portion
of the spinous processes 10 as illustrated by arrows 540A and
540B.
[0045] Optionally, a tensile member 550 that is resiliently
stretchable can also be provided, e.g., at or near the first and
the second posterior anchoring ends 518 and 528. Without being
bound by any theory, it is believed that the tensile member 550 can
provide additional distraction between the top end 500 and the
bottom end 504 and additional compressive force between the
posterior portions of the spinous processes 10. Additionally, a
torsion spring (not shown) can also be placed at or near the hinge
530 resulting in a further distraction between the top end 500 and
the bottom end 504 and compression between the first and the second
posterior anchoring ends 518 and 528.
[0046] The first non-elastic anchoring member 510 and the second
non-elastic anchoring member 520 can be affixed to the bone or
simply wrapped around the spinous processes 10. Suitable methods
for affixing anchoring members 510 and 520 are well known to one
skilled in the art.
[0047] The interspinous stabilizer 100 of the present invention can
also be a two piece unit as illustrated in FIG. 6. The two piece
unit comprises a resiliently compressible body 114 that serves as a
distraction member and an operatively interconnected resiliently
stretchable member 600 that is designed to create or generate a
compressive force posterior to the distraction member. The
distraction member (i.e., resiliently compressible body 114) and
the resiliently stretchable member 600 are operatively
interconnected by the virtue of having both of them being connected
to the same adjacent spinous processes. The resiliently
compressible body 114 comprises a top anchoring end 610 and a
bottom anchoring end 614 for affixing the distraction member to the
superior and inferior spinous processes 10A and 10B.
[0048] Similar to other illustrated devices, the interspinous
stabilizer 100 shown in FIG. 6 comprises a compressive force
generating piece (i.e., resiliently stretchable member 600) that is
located posterior to the distraction member. It should be
appreciated that the distraction member and the resiliently
stretchable member 600 can be an integral unit. As with other
interspinous stabilizers 100 described herein, either one or both
of the distraction member and a compressive force generating member
can be attached to the bone or can simply be wrapped around the
superior surface of the superior process 10A or inferior surface of
the inferior process 10B.
[0049] FIG. 7 illustrates an interspinous stabilizer 100 of the
present invention that comprises a resiliently compressible body
114 comprising a top end 704 and a bottom end 708. The interspinous
stabilizer 100 of FIG. 7 further comprises a superior anchoring
member 710 and an inferior anchoring member 720. The superior
anchoring member 710 comprises a superior anterior anchoring end
714 that is connected to the top end 704 and a superior posterior
anchoring end 718 that is adapted for anchoring to the superior
spinous process 10A posterior to the resiliently compressible body
114. Likewise, the inferior anchoring member 720 comprises an
inferior anterior anchoring end 724 that is connected to the bottom
end 708 and an inferior posterior anchoring end 728 that is adapted
for anchoring to the inferior spinous process 10B posterior to the
resiliently compressible body 114.
[0050] As stated before, the resiliently compressible body 114 can
include a coil spring (not shown) encapsulated within a body to
provide resiliency. In this manner, the body 114 can comprise a
non-resilient material. Referring again to FIG. 7, the resiliently
compressible body 114 is placed between a superior spinous process
10A and an inferior spinous process 10B to create a desired
distraction. A compressive force is applied to the spinous
processes 10 posterior to the resiliently compressible body 114.
Without being bound by a theory, it is believed that having both
the compressive force and distraction results in creation of a
rotational moment as indicated by arrows 740A and 740B.
Implantation of the implantable stabilizer 100 of FIG. 7 is
typically carried out by affixing the superior anchoring member 710
and the inferior anchoring member 720 to the spinous processes 10
while the rotational moment is applied.
[0051] FIGS. 8A and 8B illustrate an interspinous implant that
comprises a resiliently compressible elongated body 810, a first
anchoring member 820 and a second anchoring member 830. The
resiliently compressible elongated body 810 is adapted for
positioning between a superior spinous process 10A and an inferior
spinous process 10B. The resiliently compressible elongated body
810 comprises an anterior end 814 and a posterior end 818. Each of
the anchoring members 820 and 830 is comprised of an elastic
material, a rod, or other similar material, or a combination
thereof. Typically, these anchoring members 820 and 830 serve as
struts and each is comprised of a relatively stiff or
non-stretchable material.
[0052] Referring again to FIGS. 8A and 8B, the first anchoring
member 820 is affixed to the superior spinous process 10A while the
second anchoring member 830 is affixed to the inferior spinous
process 10B. In addition, two anchoring members 820 and 830 are
attached to the resiliently compressible elongated body 810 at
different positions of the resiliently compressible elongated body
810, e.g., one is attached relatively posterior to the other. This
allows the resiliently compressible elongated body 810 to lift at
one end during flexion as shown in FIG. 8B and provide a counter
force that stabilizes the spine.
[0053] FIGS. 9A, 9B, and 9C show another interspinous stabilizer
100 configuration of the present invention. This configuration
comprises a resiliently flexible U-shaped body 900 comprising a
central portion 910 and two branches 920A and 920B. The U-shaped
body 900 is adapted for positioning between adjacent superior and
inferior spinous processes (not shown in FIGS. 9A and 9B). Each of
the branches 920A and 920B is adapted for contacting the surfaces
of the spinous processes when the stabilizer 100 is implanted. The
branches 920A and 920B can optionally comprise a pair of tabs 930
that project from an outer face of the branches, thereby providing
a stirrup-like configuration for receiving a spinous process of a
vertebra. These tabs 930 help stabilize and/or locate the U-shaped
body 900 medial/laterally within the spinous processes.
[0054] The interspinous stabilizer 100 of FIGS. 9A, 9B, and 9C also
comprises a resiliently stretchable anchoring member 940 that is
operatively connected to near the central portion 910 of the
U-shaped body 900. The anchoring member 940 is adapted for
attaching to the superior and inferior spinous processes 10A and
10B.
[0055] The U-shaped body 900 may also comprise an anchoring member
affixing element 950, preferably, within an interior surface of the
U-shaped body 900. The anchoring member affixing element 950 is
adapted to affix the optional anchoring member 940 to the U-shaped
body 900. The anchoring member affixing element 950 can be an open
slot located within the U-shaped body 900. In this manner,
anchoring member 940 can be inserted through the open slot (i.e.,
anchoring member affixing element 950) and affixed to a spinous
process. See FIG. 9B. While FIGS. 9A and 9B show a U-shaped body
having two open slots for affixing the anchoring member 940, it
should be appreciated that a single anchoring member affixing
element 950 (e.g., an open slot) can be used to attach both
anchoring members 940.
[0056] Generally, at the junction between the central portion 910
and the branches 920A and 920B, an opening is used as the anchoring
member affixing element 950 to accommodate the method of
attachment. The anchoring member affixing element 950 is typically
used for affixing or placing a flexible cable, e.g., resiliently
stretchable anchoring member 940, that maintains an appropriate
mechanical advantage to support the vertebral bodies while reducing
the incidence of kyphosis due to the moment induced as a result of
the offset placement. The resiliently stretchable anchoring member
can comprise, but is not limited to, a round cord or a flat
strap.
[0057] The stabilizer 100 shown in FIG. 9A comprises a pair of
relatively flat springs (branches 920A and 920B) that are
relatively parallel to each other. However, as shown in FIG. 9C,
these two flat springs need not be parallel to each other. In fact,
in some cases it is preferred that these two springs are at an
angle with respect to one another. Typical configuration will often
be dictated by the configuration of the two adjacent spinous
processes to be stabilized.
[0058] Preferably, the interspinous stabilizers 100 of the present
invention provide rotational moment, i.e., apply force to restore
lordosis, at all times. In some configurations, such as the
interspinous stabilizers 100 illustrated in FIGS. 5, 6, 8A and 8B,
can be made to apply rotational moment only in response to flexion
induced kyphosis, i.e., forward bending of the spine by the
patient.
[0059] Other aspects of the present invention provide methods for
dynamically stabilizing vertebral bodies using various interspinous
stabilizers 100 disclosed herein.
[0060] The foregoing discussion of the invention has been presented
for purposes of illustration and description. The foregoing is not
intended to limit the invention to the form or forms disclosed
herein. Although the description of the invention has included
description of one or more embodiments and certain variations and
modifications, other variations and modifications are within the
scope of the invention, e.g., as may be within the skill and
knowledge of those in the art, after understanding the present
disclosure. It is intended to obtain rights which include
alternative embodiments to the extent permitted, including
alternate, interchangeable and/or equivalent structures, functions,
ranges or steps to those claimed, whether or not such alternate,
interchangeable and/or equivalent structures, functions, ranges or
steps are disclosed herein, and without intending to publicly
dedicate any patentable subject matter.
* * * * *