U.S. patent application number 14/718447 was filed with the patent office on 2015-09-24 for telescoping interspinous fixation device and method of use.
The applicant listed for this patent is LANX, INC.. Invention is credited to Patrick Hunt, Dean Karahalios, Andrew Lamborne, Randy Mast, William Sandul, Justin Taber.
Application Number | 20150265413 14/718447 |
Document ID | / |
Family ID | 48745543 |
Filed Date | 2015-09-24 |
United States Patent
Application |
20150265413 |
Kind Code |
A1 |
Taber; Justin ; et
al. |
September 24, 2015 |
TELESCOPING INTERSPINOUS FIXATION DEVICE AND METHOD OF USE
Abstract
The present invention provides spinous process implants and
associated methods. In one aspect of the invention, the implant
includes a first extension and a second extension. The first
extension has a spacer extending from a medial facing side along a
longitudinal axis. The second extension has an aperture that
slidingly receives the spacer. Accordingly, the second extension is
moveable relative to the spacer along the longitudinal axis. The
second extension includes a threaded bore in communication with the
aperture. A set screw is threadably received in the threaded bore
of the second extension. The set screw can be tightened against an
outer surface of the spacer to lock the second extension in place
relative to the longitudinal axis.
Inventors: |
Taber; Justin; (Lafayette,
CO) ; Hunt; Patrick; (Denver, CO) ; Lamborne;
Andrew; (Golden, CO) ; Mast; Randy;
(Broomfield, CO) ; Sandul; William; (Broomfield,
CO) ; Karahalios; Dean; (Lake Forest, IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
LANX, INC. |
Broomfield |
CO |
US |
|
|
Family ID: |
48745543 |
Appl. No.: |
14/718447 |
Filed: |
May 21, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14113785 |
Oct 24, 2013 |
9066760 |
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PCT/US2013/020369 |
Jan 4, 2013 |
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14718447 |
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61583219 |
Jan 5, 2012 |
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Current U.S.
Class: |
623/17.16 |
Current CPC
Class: |
A61B 17/7064 20130101;
A61B 17/7061 20130101; A61B 17/7065 20130101; A61F 2002/30593
20130101; A61B 17/7068 20130101; A61F 2/4405 20130101 |
International
Class: |
A61F 2/44 20060101
A61F002/44; A61B 17/70 20060101 A61B017/70 |
Claims
1. An implant having a portion adapted to be placed between spinous
processes of adjacent vertebrae of a spine, the implant comprising:
a first extension having a lateral facing side and a medial facing
side, the medial facing side adapted to reside proximate to at
least one of the spinous processes, the first extension defining a
longitudinal axis that extends substantially perpendicular to the
medial facing side; a spacer extending from the medial facing side
of the first extension along the longitudinal axis; the spacer
including a first end adjacent the medial facing side of the first
extension and a second end opposite the first end; the spacer
having an outer surface that extends between the first and second
ends; a second extension having a lateral facing side and a medial
facing side, the medial facing side adapted to reside proximate to
at least one of the spinous processes, the second extension
defining an aperture that slidingly receives the spacer such that
the second extension is moveable relative to the spacer along the
longitudinal axis; the second extension having a threaded bore in
communication with the aperture; and a set screw threadably
received in the threaded bore of the second extension that is
adapted to be tightened against the outer surface of the spacer to
lock the second extension in place relative to the longitudinal
axis, wherein the aperture of the second extension is larger than
the outer surface of the spacer by a predetermined amount in order
to permit a pre-determined amount of angular adjustment between the
first extension and the second extension and wherein the threaded
bore of the second extension is transverse to the longitudinal axis
allowing the second extension to pivot about the set-screw.
2. The implant of claim 1, wherein the arrangement of the threaded
bore relative to the longitudinal axis and the size of the aperture
relative to the outer surface of the spacer allow the first and
second extensions to be set in a non-parallel relationship.
3. The implant of claim 1, wherein the outer surface of the spacer
includes a posterior side, the threaded bore of the second
extension being open to the posterior side of the spacer such that
the set screw is adapted to move into contact with the posterior
side of the spacer.
4. The implant of claim 3, wherein the spacer has first and second
anterior chamfers disposed at the first and second ends of the
spacer opposite the posterior side, the first and second anterior
chamfers providing clearance for posteriorly facing structures of
the adjacent vertebrae of the spine.
5. The implant of claim 3, wherein the posterior side of the spacer
has surface texturing adapted to cooperatively engage a leading
edge of the set screw.
6. The implant of claim 1, wherein the spacer has an inner surface
defining a hollow interior adapted to receive a bone growth
promoting substance for facilitating fusion between the implant and
the adjacent vertebrae of the spine.
7. The implant of claim 1, wherein the first and second extensions
define a midline plane that bisects the first and second extensions
and that runs parallel to the longitudinal axis.
8. The implant of claim 7, wherein the first and second extensions
each have a superior lobe that is offset to one side of the midline
plane and an inferior lobe that is offset to another side of the
midline plane.
9. The implant of claim 8, wherein each of the superior lobes and
each of the inferior lobes of the first and second extensions
include at least one fastener extending from the medial facing
sides of the first and second extensions for securing the first and
second extensions to the adjacent vertebrae of the spine.
10. The implant of claim 7, wherein the spacer is centered about
the longitudinal axis and the longitudinal axis is offset from and
anterior to the midline plane.
11. An implant having a portion adapted to be placed between
spinous processes of adjacent vertebrae of a spine, the implant
comprising: a first extension having a lateral facing side and a
medial facing side, the medial facing side adapted to reside
proximate to at least one of the spinous processes, the first
extension defining a longitudinal axis that extends substantially
perpendicular to the medial facing side; a spacer extending from
the medial facing side of the first extension along the
longitudinal axis; the spacer including a first end adjacent the
medial facing side of the first extension and a second end opposite
the first end; the spacer having a posterior side, a superior outer
surface, and an inferior outer surface each extending between the
first and second ends, the posterior side disposed between the
superior and inferior outer surfaces; a second extension having a
lateral facing side and a medial facing side, the medial facing
side adapted to reside proximate to at least one of the spinous
processes, the second extension defining an aperture that slidingly
receives a portion of the spacer such that the second extension is
moveable relative to the spacer along the longitudinal axis; the
second extension having a threaded bore in communication with the
aperture; and a set screw threadably received in the threaded bore
of the second extension that is adapted to be tightened against the
posterior side of the spacer to fix the second extension in place
relative to the longitudinal axis, wherein the superior and
inferior outer surfaces of the spacer each has an elongated slot
disposed therein and the second extension has first and second tabs
extending inwardly into the aperture that are received by and
arranged in sliding engagement with the elongated slots in the
superior and inferior outer surfaces.
12. The implant of claim 11, wherein the first and second tabs are
directed toward the posterior side of the spacer.
13. The implant of claim 12, wherein the first and second tabs are
angled toward the posterior side of the spacer.
14. The implant of claim 12, wherein the first and second tabs are
hooked toward the posterior side of the spacer.
15. The implant of claim 11, wherein the elongated slots have sides
and the first and second tabs are pressed against the sides of the
elongated slots when the set screw is tightened against the
posterior side of the spacer in order to lock the second extension
in place at a finite location along the spacer.
16. The implant of claim 11, wherein the elongated slots in the
superior and inferior outer surfaces extend linearly and are
parallel to the longitudinal axis.
17. The implant of claim 11, wherein the elongated slots in the
superior and inferior outer surfaces are closed at the first end of
the spacer and are open at the second end of the spacer.
18. The implant of claim 11, wherein the spacer has an inner
surface defining a hollow interior and the elongated slots in the
superior and inferior outer surfaces open into the hollow interior
of the spacer.
19. The implant of claim 11, wherein the aperture of the second
extension includes complementary surfaces that face the superior
outer surface, the inferior outer surface, and the posterior side
of the spacer and wherein the aperture is open between the first
and second tabs such that the second extension has a "C" shaped
cross-section adjacent the aperture.
20. The implant of claim 11, wherein the second extension extends
completely about the aperture and the portion of the spacer that is
received in the aperture.
Description
PRIORITY
[0001] This application claims priority under 35 U.S.C. .sctn.119
to U.S. Provisional Patent Application Ser. No. 61/583,219, filed
Jan. 5, 2012, titled Telescoping Interspinous Fixation Device and
Methods of Use, which is incorporated herein by reference as if set
out in full.
CROSS-REFERENCE TO RELATED APPLICATIONS
[0002] This application is a continuation of U.S. patent
application Ser. No. 14/113,785, filed Oct. 24, 2013, titled
Telescoping Interspinous Fixation Device And Methods of Use and is
related to U.S. patent application Ser. No. 11/934,604, filed Nov.
2, 2007, titled Spinous Process Implants and Associated Methods,
now U.S. Pat. No. 8,241,330; U.S. patent application Ser. No.
12/020,282, filed Jan. 25, 2008, titled Spinal Implants and
Methods; U.S. patent application Ser. No. 12/751,856, filed Mar.
31, 2010, titled Spinous Process Implants and Associated Methods;
U.S. patent application Ser. No. 12/538,710, filed Aug. 10, 2009,
titled Spinous Process Implants, Instruments, and Methods; U.S.
patent application Ser. No. 12/854,125, filed Aug. 10, 2010, titled
Interspinous Implants and Methods; U.S. patent application Ser. No.
13/460,738, filed Apr. 30, 2012, titled Spinous Process Implants
and Associated Methods; and U.S. patent application Ser. No.
13/584,661, filed Aug. 13, 2012, titled Spinous Process Implants
and Associated Methods; all of which are incorporated herein by
reference as if set out in full.
FIELD
[0003] The technology of the present application relates to spinal
implants and, more specifically, to an interspinous implant for
fixation to one or more spinous processes of a spine.
BACKGROUND
[0004] The vertebrae of the human spine are arranged in a column
with one vertebra on top of the next. An intervertebral disc lies
between adjacent vertebrae to transmit force between the adjacent
vertebrae and provide a cushion between them. The discs allow the
spine to flex and twist. With age or injury, spinal discs begin to
break down, or degenerate, resulting in the loss of fluid in the
discs, and consequently, the discs become less flexible. Likewise,
the discs become thinner allowing the vertebrae to move closer
together. Degeneration also may result in tears or cracks in the
outer layer, or annulus, of the disc. The disc may begin to bulge
outwardly. In more severe cases, the inner material of the disc, or
nucleus, may actually extrude out of the disc. In addition to
degenerative changes in the disc, the spine may undergo changes due
to trauma from automobile accidents, falls, heavy lifting, and
other activities. Furthermore, in a process known as spinal
stenosis, the spinal canal narrows due to excessive bone growth,
thickening of tissue in the canal (such as ligament), or both. In
all of these conditions, the spaces through which the spinal cord
and the spinal nerve roots pass may become narrowed leading to
pressure on the nerve tissue which can cause pain, numbness,
weakness, or even paralysis in various parts of the body. Finally,
the facet joints between adjacent vertebrae may degenerate and
cause localized and/or radiating pain. All of the above conditions,
as well as others not specifically mentioned, are collectively
referred to herein as spine disease.
[0005] Conventionally, surgeons treat spine disease by attempting
to restore the normal spacing between adjacent vertebrae. This may
be sufficient to relieve pressure from affected nerve tissue.
However, it is often necessary to surgically remove disc material,
bone, or other tissues that impinge on the nerve tissue and/or to
debride the facet joints. Most often, the restoration of vertebral
spacing is accomplished by inserting a rigid spacer made of bone,
metal, or plastic into the disc space between the adjacent
vertebrae and allowing the vertebrae to grow together, or fuse,
into a single piece of bone. The vertebrae are typically stabilized
during this fusion process with the use of bone plates and/or
pedicle screws fastened to the adjacent vertebrae.
[0006] Although techniques for placing intervertebral spacers,
plates, and pedicle screw fixation systems have become less
invasive in recent years, they still require the placement of
hardware deep within the surgical site adjacent to the spine.
Recovery from such surgery can require several days of
hospitalization and long, slow rehabilitation to normal activity
levels.
[0007] Rather than spinal fusion, investigators have promoted the
use of motion preservation implants and techniques in which
adjacent vertebrae are permitted to move relative to one another.
One such implant that has met with only limited success is the
artificial disc implant. The artificial disc typically includes
either a flexible material or a two-piece articulating joint
inserted in motion preservation devices. Another such implant is
the spinous process spacer which is inserted between the
posteriorly extending spinous processes of adjacent vertebrae to
act as an extension stop and to maintain a minimum spacing between
the spinous processes when the spine is in extension. The spinous
process spacer allows the adjacent spinous processes to move apart
as the spine is flexed. The extension stop spacers, however, also
have had limited success.
[0008] Recently, the trend has been back towards fusion devices
rather than motion preservation devices. One promising recent
implant is a spinal process fusion plate. Similar to the fusion
implants, the spinal process fusion plate promotes fusion between
adjacent vertebrae to relieve pressure on the nerve. However,
unlike more conventional spinal implant systems, the spinal process
fusion plate facilitates less invasive procedures than conventional
spinal fusion surgery. The need still exists for improved spinal
process fusion plates to facilitate even less invasive surgery
including, minimally invasive surgery, percutaneous implantation,
and the like. Such less invasive surgery may be accomplished by an
implant that may be implanted in a more compact or relatively
compact state and expanded or enlarged state.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] Various examples of the technology of the present
application will be discussed with reference to the appended
drawings. These drawings depict only illustrative examples of the
technology described more fully herein and are not to be considered
limiting of its scope.
[0010] FIG. 1 is a posterior cross sectional view of an implant in
situ that is deployed using a tool consistent with the technology
of the present application;
[0011] FIG. 2 is a side elevational view of the implant of FIG. 1
in situ;
[0012] FIG. 3 is an exploded perspective view of the-implant of
FIG. 1;
[0013] FIG. 4 is a posterior elevational view of the implant of
FIG. 1;
[0014] FIG. 5 is an anterior elevational view of the implant of
FIG. 1;
[0015] FIG. 6 is a top plan view of the implant of FIG. 1;
[0016] FIG. 7 is a posterior elevational view of the implant of
FIG. 1 showing the assembly in an alternate position;
[0017] FIG. 8 is a side elevational view of the implant of FIG.
1;
[0018] FIG. 9 is a perspective view of a pair of implants like that
of FIG. 1 in situ;
[0019] FIGS. 10A-D are views of an implant that is consistent with
the technology of the present application;
[0020] FIG. 11 is a perspective view of a part of the implant;
[0021] FIG. 12 is a perspective view of a part of the implant;
[0022] FIG. 13 is a perspective view of a part of the implant;
[0023] FIG. 14 is a view of a part of the implant;
[0024] FIG. 15 is a view of a part of the implant;
[0025] FIG. 16 is a view of a part of the implant;
[0026] FIG. 17 is a view of a part of the implant;
[0027] FIG. 18 is a view of a part of the implant;
[0028] FIG. 19 is a view of part of the implant;
[0029] FIG. 20 is a view of part of the implant;
[0030] FIG. 21 is a perspective view of a part of the implant;
[0031] FIG. 22 is a view of a part of the implant;
[0032] FIG. 23 is a perspective view of a part of the implant;
[0033] FIG. 24 is a view of a part of the implant;
[0034] FIGS. 25-27 are views of parts of the implant consistent
with the technology of the application;
[0035] FIGS. 28-30 are views of parts of the implant consistent
with the technology of the application;
[0036] FIGS. 31-33 are view of a screw associated with the implant
consistent with the technology of the application; and
[0037] FIGS. 34-40 are view of tools usable with the technology of
the application.
DESCRIPTION OF THE ILLUSTRATIVE EXAMPLES
[0038] The technology of the present application will be described
in the context of spinal surgery, but one of ordinary skill in the
art will recognize on reading the disclosure that the technology
may be applicable to other medical fields. Moreover, the technology
of the present application will be described with reference to
certain exemplary embodiments. The word "exemplary" is used herein
to mean "serving as an example, instance, or illustration." Any
embodiment described herein whether or not specifically identified
as "exemplary" is not to be construed as preferred or advantageous
over other embodiments. It also should be understood that
terminology employed herein is used for the purpose of describing
particular embodiments only and is not intended to be limiting. It
must be noted that, as used in this specification, the singular
forms "a," "an," and "the" include plural references unless the
context of the disclosure clearly dictates otherwise. Thus, for
example, reference to "a lithium hydroxide" is not to be taken as
quantitatively or source limiting, reference to "a step" may
include multiple steps, reference to "producing" or "products" of a
reaction should not be taken to be all of the products of a
reaction, and reference to "reacting" may include reference to one
or more of such reaction steps. As such, the step of reacting can
include multiple or repeated reaction of similar materials to
produce identified reaction products.
[0039] Further, the instrument(s) described in accordance with the
technology of the present application facilitate surgical
implantation of spinal process fusion plates. With that in mind,
exemplary spinous process implants, according to the technology,
may include a spacer and an extension extending outwardly from the
spacer. The extension, which may be referred to as a wing, is
sometimes described as being one or more lobes associated with the
spacer. In certain aspects, the spacer may be integral or
monolithic with one of the extensions. In other aspects, the spacer
may be separate from all of the associated wings. The spinous
process implant may be configured for insertion between adjacent
spinous processes of the cervical, thoracic, and/or lumbar spine.
The spacer may be provided in a variety of sizes to accommodate
anatomical variation amongst patients and varying degrees of space
correction. The spacer and extensions may include openings,
recesses, pockets, etc. to facilitate tissue in-growth to anchor
the spacer to the vertebral bodies such as tissue in-growth from
the spinous processes. The spacer may be configured for tissue
in-growth from superior and inferior spinous processes to cause
fusion of the adjacent spinous processes. The openings may be
relatively large and/or communicate to a hollow interior of the
spacer or a hole, pocket, or recess in the extensions. A hollow
interior may be configured to receive bone growth promoting
substances such as by packing the substances into the hollow
interior. The openings may be relatively small and/or comprise
pores or interconnecting pores over at least a portion of the
spacer surface. The openings, however formed, may be filled with
bone growth promoting substances.
[0040] In certain aspects, the implant may be described as
telescoping. A telescoping implant may generally be described as an
implant that has multiple parts where at least a portion of the
parts comprises a male protrusion that slidably engages a female
socket to allow the male protrusion to slidably engage the female
socket. A telescoping spinous process fusion plate may offer a
number of functional advantages over other implants, such as a
fixed length spinous process fusion plate. In certain embodiments,
the telescoping spinous process fusion plate may provide: (1)
compression of fixation devices extending from the extensions into
one or more spinous processes, then manipulating the implant to
compress or distract the interspinous space by providing a compact
or enlarged configuration of the implant, (2) may compress or
lordose when using a posterior interbody (transforaminal lumbar
interbody fusion (TLIF) or posterior lumbar interbody fusion (PLIF)
for example) to reduce the risk of expulsion from the fusion site,
(3) distraction without (or without compressing) the fasteners
extending from the extension to allow for functionality similar to
an adjustable height extension stop, and (4) facilitate
implantation by providing a compact insertion state and an enlarged
or expanded distraction state.
[0041] A compact or reduced height insertion state may be
particularly useful when the supraspinous ligament (SSL) is left
intact as the compact or collapsed height of the telescoping
implant may be approximately four (4) millimeters to about ten (10)
millimeters. In certain aspects the collapsed height of the implant
may be four (4), six (6), or eight (8) millimeters. However, if the
SSL is sacrificed or removed, the implant may be fully assembled
and inserted directly to the interspinous space using a posterior
approach. Providing a compact height of 4-8 or 4-10 millimeters may
provide for a smaller incision and surgical corridor. Moreover, the
compact or reduced height of the implant (reduced as compared to
the expanded or enlarged height) also may facilitate implantation
when the posterior aspects of the spinous process are abutting or
in close proximity, sometimes referred to as "kissing." Also, when
the SSL is sacrificed, the telescoping implant may be a unitary
unit with extensions attached to both sides of the spacer.
[0042] Whether unitary or modular, the extension may extend
transversely from the spacer relative to a spacer longitudinal axis
to maintain the spacer between adjacent spinous processes. The
extension may be described as foldable, extendable, deployable or
the like from a flat configuration to facilitate minimally invasive
implantation to an extended position to facilitate fusion. A single
extension may extend in one or more directions or multiple
extensions may be provided that extend in multiple directions. One
or more extensions may be adjustable longitudinally relative to one
another and/or the spacer to allow the extensions to be positioned
laterally relative to the spinous processes. A moveable extension
may be provided that is moveable axially relative to the spacer and
another extension. Alternatively, a plurality of moveable
extensions may be provided. For example, the extensions may clamp
against the sides of the spinous processes to immobilize the
spinous processes relative to one another and promote fusion
between the adjacent vertebrae. The extensions may include
fasteners engageable with the spinous processes. The fasteners may
include sutures, wires, piris, straps, clamps, spikes, screws,
teeth, adhesives, and/or other suitable fasteners. The fasteners
may be integrated into the extensions or they may be modular.
Modular fasteners may be adjustable, replaceable, and/or removable
to allow tailoring of the kind and quality of fixation from rigid
fixation to no fixation. The spacer, extensions, and/or fasteners
may advantageously be made of different materials. For example, the
spacer and extensions may be made of a relatively softer material
while the fasteners may be made of a relatively harder material.
For example, the spacer and/or extension may be made of a polymer
and/or other relatively soft material and the fastener may be made
of a metal and/or other relatively hard material.
[0043] Insertion of spinous process implants may be facilitated by
a set of instruments alternately engageable with one another to
increase the interspinous space and engageable with a spinous
process implant to help maneuver it between adjacent spinous
processes as has been described in some of the related applications
described above and incorporated by reference. Moreover,
instruments for the present spinous process implant may facilitate
percutaneous operation whether through a cannula, tube, or lumen.
The instruments may include mechanisms to facilitate telescoping,
unfolding, opening, or deploying portions of the implant including
the extensions and spacer. The instruments may include a draw
internal or external to the spacer to pull the extensions in a
direction such that the extensions are pried apart by a wedge or
ramp.
[0044] It has been found that presently available interspinous
implants, such as the device explained with reference to FIGS. 1-9,
are good at stabilizing a spinal segment to allow it to fuse. The
interspinous implant could be implanted with less tissue trauma
percutaneously or through a tube, cannula, or lumen if the spacer
was provided in a compact state and expanded to a distraction state
subsequent to the placement of the spacer between adjacent spinous
processes. In certain embodiments, the implant, when in the compact
state, fits within the space between adjacent spinous processes
without abutting both processes and in some cases, may fit within
the space without abutting either spinous process until the implant
is partially expanded.
[0045] In other embodiments, the implant may slightly distract the
spinous processes when in the compact state. Expanding the spacer
to the distraction state may be subsequent to manual distraction of
the vertebral bodies or may be in conjunction with expanding the
spacer. Expanding the spacer may be accomplished by providing a
spacer body with a superior and inferior portion that have internal
surfaces that are ramped to cooperatively engage an internal body
that is wedge shaped or ramped such that drawing the internal body
laterally through an interspinous space may cause at least one of
the superior and inferior portions to move apart in a distraction
direction. In other embodiments, the spacer may be mounted on a
post that telescopes into a bore such that the post may be expanded
from the bore to cause expansion. In still other embodiments, the
extensions may have a post and socket where the post and socket
allow for ratcheted movement to telescope the spacer.
[0046] In certain embodiments, one or both of the extensions may be
a foldable or collapsible extension to further compact the implant
prior to placement. One or more of the extensions may have offset
fasteners on the foldable extension and corresponding bores into
which the fasteners may fit to allow a flat or nearly flat
configuration of the folded wing for the most compact delivery
possible. The foldable extensions may fold about an axle or be
hinged to allow for movement. A draw, rod, or hook may be connected
to the hinge or axle to pull the hinge or axle towards the spacer
that causes the face or surface of the extension to run up against
an edge that forces the folded extension to unfold. In some
embodiments, internal rods and ramps may be used to force the
folded extension to unfold or open.
[0047] For completeness, reference will now be made to FIGS. 1-9
describing an exemplary embodiment of a spinous process implant
with a fixed and non-expandable spacer as well as at least one
fixed or non-foldable extension. As will be explained further
below, the spacer may be replaced with an expandable or telescoping
spacer that is expandable before or after implantation from a
compact or insertion state to a distraction or expanded state.
While specific exemplary embodiments are provided herein, implants
associated with any of the incorporated applications or similar
spinous process fusion plates may benefit from the technology of
the present application to allow telescoping or expanding implants
with or without extensions or wings that fold to facilitate
implantation. Moreover, it may be especially beneficial to
incorporate a foldable extension with the technology of the present
application to allow for a compact implant for delivery through
minimally invasive procedures, for example.
[0048] FIGS. 1 and 2 depict posterior and lateral views of a pair
of adjacent vertebrae of the lumbar spine 10. A superior vertebra
12 is separated from an inferior vertebra 14 by a disc 16. Each
vertebra includes a pair of transverse processes 18, 19, a
posteriorly projecting spinous process 20, 21, and a pair of lamina
22, 23 connecting the transverse processes 18, 19 to the spinous
process 20, 21. In addition to the connection through the disc 16,
the vertebrae 12, 14 articulate at a pair of facet joints 24.
[0049] FIGS. 1-9 illustrate an exemplary spinous process implant
100. The implant 100 includes a spacer 102 positioned between the
spinous processes 20, 21. The geometry of the implant 100 is
illustrated with the use of axes that define length (1), height
(h), and width (w) directions for the spacer. When implant 100 is
implanted in a patient, the height direction of the spacer 102 is
generally oriented along the superior/inferior direction of the
patient's anatomy, the width direction of the spacer 102 is
generally oriented along the anterior/posterior direction of the
patient's anatomy, and the length direction of the spacer 102 is
generally oriented along the lateral/medial direction of the
patient's anatomy.
[0050] The height 104 (FIG. 1) of spacer 102 limits how closely the
spinous processes 20, 21 can move together. As the implant in this
example is a fusion plate, the height also limits how distantly the
spinous processes 20, 21 can move apart. Thus, the spacer 102
maintains a minimum and maximum distance between the spinous
processes 20, 21. In the case of spine disease involving posterior
subsidence of the adjacent vertebra, insertion of the spacer 102
between the spinous processes 20, 21 will move the vertebrae apart
and relieve pressure on nerve tissue and the facet joints 24.
[0051] As shown in FIG. 3, the spacer 102 includes a first end 106,
a second end 108, and a longitudinal axis 110 extending from the
first end to the second end. The spacer 102 has a sidewall 112,
generally parallel to the longitudinal axis 110, including superior
and inferior outer surfaces 114, 116. Transverse openings 118 (see
also FIG. 6) communicate from the superior and inferior outer
surfaces 114, 116 inwardly to facilitate tissue in-growth. The
exemplary spacer 102 includes a hollow interior 120 bounded by an
inner surface 122 such that the openings 118 communicate from the
outer surfaces 114, 116 to the hollow interior 120. Bone growth
promoting substances 124 are shown packed into the hollow interior
120 in FIGS. 1 and 2 to promote fusion of the vertebrae 12, 14 by
bone growth between the spinous processes 20, 21.
[0052] The spinous process implant 100 further includes a first
extension 126 projecting outwardly from the spacer 102 along the
spacer height direction h and transversely to the longitudinal axis
110 to lie generally alongside the superior and inferior spinous
processes 20, 21. Abutment of the first extension 126 with the
spinous processes 20, 21 helps prevent lateral movement of spacer
102, thereby maintaining spacer 102 between the spinous processes
20, 21. In the exemplary spinous process implant 100, the first
extension 126 is fixed relative to the spacer 102. When fixed, the
first extension 126 may be generally unitary with spacer 102 or the
first extension 126 and spacer 102 may form a monolithic unit. The
implant 100 also includes a second extension 128 mountable to the
spacer for axial movement relative to the first extension 126. The
second extension 128 may be moved toward the first extension 126 to
approximate the width of the spinous processes 20, 21 and better
stabilize the implant 100. It is fixed in place by tightening a set
screw 130 (FIG. 3) against the spacer 102. The extensions 126, 128
include fasteners 132, 134, 136 projecting from the extensions 126,
128 to engage the spinous processes 20, 21 to fix the spacer 102 to
the spinous processes 20, 21. FIG. 1 depicts an additional bone
growth promoting substance in the form of strips of bone 125
sandwiched between the extensions 126, 128 along the sides of the
spinous processes 20, 21 to promote bone growth along the sides of
the spinous processes to further enhance fusion of the vertebrae
12, 14. As an alternative to strips of bone 125, the bone 125 may
be formed similar to a washer or ring to cooperatively fit about
the fasteners 132, 134, 136 to promote bone growth. While the
extensions 126, 128 may extend in only one of inferiorly or
superiorly from the spacer 102, the extensions 126, 128 preferably
extend inferiorly as well as superiorly from spacer 102 to
optionally attach to both the inferior and superior spinous
processes to immobilize the spinous processes 20, 21 relative to
one another while fusion takes place.
[0053] Fasteners 132, 134, and 136 may take any suitable form. They
may be made integral with the extensions 126, 128 such as by
machining or casting them with the extensions or they may be formed
separately and permanently attached to the extensions 126, 128.
Fastener 132 is a sharpened spike that threadably engages the
extension 126. The threaded engagement allows the fastener 132 to
be replaced with a different fastener 132. For example, the
fastener 132 may be replaced by one that has a different shape, a
different size, a different material, or a different surface
coating. The threaded engagement also allows the fastener 132 to be
adjusted to extend by varying amounts from the extension 126 to
vary how it engages the bone. Thus, the fastener 132 can be
adjusted to fit differently shaped bones or to penetrate into a
bone by varying amounts. For example, multiple threaded fasteners
132 can be adjusted to extend by different amounts to conform to
curved or angled bone. Finally, the threaded engagement allows the
user to remove the fastener 132 when fixation is not desired such
as when it is desired to use implant 100 in a non-fusion procedure
as an extension stop without limiting flexion.
[0054] As best seen in FIG. 3, fasteners 134 and 136 are provided
as multi-spike pods allowing a plurality of spikes to be quickly
adjusted, changed, or omitted. Fastener 134 includes a non-circular
tab 138 engageable with a non-circular opening 140 in the extension
126. The non-circular engagement prevents the fastener 134 from
rotating. The tab 138 may form a press-fit, snap-fit, or other
suitable engagement with the opening 140. The tab 138 may be
further secured by a supplemental screw 142. Fastener 136 includes
a threaded shaft 144 threadably engaged with a base member 146 to
allow the length of the fastener 136 to be adjusted. The shaft 144
engages the extension 126 in a rotating and pivoting manner such
that the fastener 136 can be adjusted rotationally and angularly to
engage the bone surface. In the illustrative embodiment, the shaft
144 terminates in a spherical ball 148 that engages the opening 140
in a ball-and-socket arrangement for three degrees of freedom.
However, any mechanism that allows any number of degrees of freedom
may be used. The fastener 136 may be allowed to move in use so that
as the extension 126 is pressed toward a bone, the fastener 136
adjusts to the angle of the bone surface. The fastener 136 also may
be secured, such as by screw 142, to adjust the tension in the
joint and/or to lock the fastener 136 in a predetermined
orientation.
[0055] FIG. 4 illustrates the axial relationship of fasteners on
the opposing extensions 126, 128. In the illustrative implant 100,
the fasteners 132 at the top of the implant 100 are shown aligned
along a common axis 150 that is substantially perpendicular to
extensions 126 and 128. The fasteners 134 at the bottom of the
implant 100 are shown offset so that they can interleave, if
necessary, as they are pressed into a bone. Any combination of
fastener type, number, and alignment may be provided on the implant
100.
[0056] As seen in FIGS. 5 and 6, the ends 106, 108 of the spacer
102 include anterior chamfers 152. These chamfers 152 allow the
ends 106, 108 to clear posteriorly facing structures of the
vertebrae 12, 14 such as the facet joints 24. Also, as seen in
FIGS. 5 and 6, the spacer 102 is offset anteriorly (in the spacer
width direction w) relative to the extensions 126, 128 such that
the longitudinal axis 110 of the spacer 102 is anterior of a
midline plane 154 (FIGS. 6, 8) of the extensions 126, 128. The
anterior offset of the spacer 102 allows it to fit deeply between
the spinous processes 20, 21 while the extensions 126, 128 fit
alongside the spinous processes 20, 21.
[0057] As best seen in FIGS. 3 and 8, the second extension 128
defines an aperture 155 conforming generally to the cross-sectional
shape of the spacer 102. In the illustrative embodiment of FIGS.
1-9, the aperture 155 opens anteriorly to form a "C"-shape,
although the aperture 155 could conform to the entire cross-section
of the spacer to form a "D" or "O" shape, for example. In the
exemplary embodiment, aperture 155 forming a generally "C"-shape
includes tabs 156 that extend inwardly from the superior and
inferior portions of the aperture to slidingly engage elongated
slots 158 in the superior and inferior surfaces of the spacer 102.
The second extension 128 can be translated longitudinally along the
spacer length l toward and away from the first extension 126.
Tightening the set screw 130 against the posterior side 160 of the
spacer 102 forces the tabs 156 posteriorly against the sides of the
slots 158 and locks the second extension 128 in place
longitudinally. The tabs 156 may increase towards the tip of the
tabs 156 to facilitate engagement with the slots 158 in the spacer
102. The tabs 156 may be hooked shaped as well instead of straight
or expanding to facilitate the cooperative engagement. The
posterior side 160 of the spacer 102 may be roughened as shown to
better grip the set screw 130. The set screw 130 may also dig into
the surface of the spacer 102 upon tightening to positively grip
the spacer 102. The aperture 155 (FIGS. 3, 8) may conform closely
to the spacer 102 to constrain the second extension 128 to
generally parallel motion relative to the first extension 126.
Alternatively, the aperture 155 may be larger than the spacer 102
by a predetermined amount to permit a predetermined amount of
angular adjustment of the second extension 128 relative to the
first extension 126 as shown in FIG. 7 to allow the extension 128
to adjust to the underlying bone surface.
[0058] As best seen in FIG. 8, the second extension 128 includes a
first inferior lobe 161 having a first lobe centerline 162 and a
second superior lobe 164 having a second lobe centerline 166. In
the illustrative embodiment, the first lobe centerline 162 and the
second lobe centerline 166 are parallel and spaced apart so that
the second extension 128 has a generally "Z"-shaped plan form. This
shape allows the extension of one implant 100 to interleave, if
necessary, with another implant 100 in a multilevel surgery (as
shown in FIG. 9) to permit close spacing of the implants, and/or
longer extension lobes for more extensive bone engagement. In
addition, first inferior lobe 161 has a semicircular convex shape
that is generally complementary to a semi-circular superior concave
surface 165 formed adjacent second superior lobe 164. Similarly,
second superior lobe 164 has a semi-circular convex shape that is
generally complementary in shape to a semi-circular inferior
concave surface 163 formed adjacent first inferior lobe 161. As
indicated in FIG. 8, first inferior lobe 161 is adjacent to
inferior concave surface 163, and extension midline plane 154 is
located between first inferior lobe 161 and inferior concave
surface 163. Second superior lobe 164 is adjacent superior concave
surface 165, and extension midline plane 154 is located between
second superior lobe 164 and superior concave surface 165.
Moreover, first inferior lobe radius r.sub.1 is substantially equal
to superior concave surface radius r.sub.4, while second superior
lobe radius r.sub.3 is substantially equal to inferior concave
surface radius r.sub.2. As a result, when two implants are placed
on adjacent spinal levels, the first inferior lobe 161 of the upper
implant may be (but need not be, depending on what is medically
indicated) interfitted into the superior concave surface 165 of the
inferior implant. In addition, the second superior lobe 164 of the
inferior implant may be interfitted into the inferior concave
surface 163 of the superior implant. In the illustrative example of
FIGS. 1-9, first inferior lobe 161 and second superior lobe 164
form a unitary second extension 128. Although not separately
depicted, first extension 126 also has complementary lobes that are
similarly configured and oriented relative to one another.
[0059] As shown in FIG. 9, multiple spinous process implants 100
may be placed on adjacent levels of the spine. As illustrated in
the figure, a first superior implant 100 is positioned with its
spacer 102 between a first superior spinous process and a second
intermediate spinous process, while a second inferior implant 100
is positioned with its spacer 102 between the second intermediate
spinous process and a third inferior spinous process. The first
extensions 126 of the superior and inferior implants are located on
a first side of the patient's sagittal plane, while the second
extensions 128 of the superior and inferior implants are located on
a second side of the patient's sagittal plane.
[0060] In the illustrative embodiment of FIGS. 1-9, the extension
lobe centerlines 162,166 are offset equidistantly from the midline
plane 154 of the second extension 128. Although not separately
shown, the first extension 126 is configured similarly. The
centerlines 162, 166 may vary from parallel and they may be offset
asymmetrically to form different shapes to accommodate different
vertebral anatomy. For example, the shape may be tailored for
different portions of the spine 10. In the illustrative embodiment
of FIGS. 1-9, the first extension 126 has the same shape as the
second extension 128. However, the shape may be varied between the
first and second extensions 126, 128.
[0061] As shown in FIGS. 1-9, the first extension 126 is integral
or unitary with the spacer 102 and second extension 128 has an
aperture 155 that is shown to partially surround the spacer to
allow the second extension 128 to translate over the outer surface
of the spacer 102. In certain embodiments, especially smaller
implants, the aperture 155 may form a through hole in second
extension 128 to completely surround the spacer 102.
[0062] Now, with reference to the remaining FIGS., an implant 200
is described. The implant 200 is shown in FIGS. 10A, 10B, and 10C
in a posterior/left lateral view (10A), a right lateral/posterior
view (10B), and an anterior/right lateral view (10C) in a partially
expanded state. In other words, the implant 200 is not shown
completely compacted or completely expanded. As shown, the implant
200 includes a first extension or wing 202 and a second extension
or wing 204. The first extension 202 may be referred to as the post
plate because a plurality of arms 206 (which will be explained
further below) may be monolithic with the first extension 202. In
the embodiment shown in FIGS. 10A-10D, the plurality of arms 206
are cantilevered from the first extension or post plate 202 along a
horizontal or transverse axis 201. The second extension 204 may be
referred to as the lock plate because it is generally free to move
with respect to the plurality of arms 206 until it is locked in
place (as will be explained further below). FIG. 10D shows implant
200 in a fully or close to fully extended or distracted state 208.
As can be appreciated, the spacer 102 of implant 100 has been
replaced by four (4) arms 206 extending from first extension 202.
One of ordinary skill in the art on reading the disclosure,
however, would now understand that the plurality of arms 206 is
only one exemplary embodiment of the present technology and the
plurality of arms 206 may be replaced by more, less, or differently
configured members that function as the spacer.
[0063] As shown in FIGS. 10A-D, the first and second extensions
202, 204 have medial sides 203 with fasteners, such as fasteners
132 described above. The fasteners on the medial sides 203 may
include any of the fasteners described above or in any of the
incorporated applications.
[0064] With reference to FIGS. 11-13, the first extension 202 and
the plurality of arms 206 of implant 200 are shown. The first
extension 202 includes a first part 208 (FIG. 12) and a second part
210 (FIG. 13). The first and second parts 208, 210 have an anterior
facing side 212 and a posterior facing side 214. The first and
second parts 208, 210 further include an anterior arm 206a.sub.1
and 206a.sub.2 and a posterior arm 206p.sub.1 and 206p.sub.2--While
shown as two anterior arms and posterior arms, the plurality of
arms 206 may include more or less arms. For example, anterior arm
206a.sub.1 may be formed contiguous with posterior arm 206p.sub.1.
Alternatively, there could be more arms, such as an anterior arm, a
posterior arm, and an interior arm. The arms 206a.sub.1 and
206p.sub.1 of the first part 208 have a top surface 216. The arms
206a.sub.2 and 206p.sub.2 of the second part 210 have a bottom
surface 218. A distance 220 between the top surface 216 and the
bottom surface 218 is adjustable, as will be explained below, from
a minimum to a maximum distance.
[0065] As seen in FIG. 12, the first part 208 has a central portion
222 that extends from the anterior facing side 212 to the posterior
facing side 214. As used herein, central portion should not be
construed to mean a middle, midline, or other geometric reference.
Rather the phrase central portion is a designator that the portion
is between, for example, inferior and superior extending parts as
will be explained further below. A threaded bore 224 opens towards
the posterior facing side 214. As will be explained further below,
a set screw or the like is threadably engaged with the threaded
bore 224 to lock the first part 208 at a height when the distance
220 is the desired spacing between the superior and inferior
spinous processes.
[0066] Extending in an inferior direction from the central portion
222 is a male member 226. The male member 226 is on the anterior
side of the first part 208. The male member 226 has a vertical axis
228. Extending in a superior direction from the central portion 222
is a female member 230. The female member 230 generally conforms
to, for example, the lobes addressed above with respect to FIGS.
1-9. In other words, the female member 230 generally conforms to a
superior lobe described above. The female member 230 is generally
hollow and forms a socket 232. The female member also has a
vertical axis 234 offset in a posterior direction from the vertical
axis 228. The female member 230 has an opening 236 at both ends of
the socket 232 to reduce the material and overall profile of the
implant. The top opening 236 could be closed with a web of
material. However, the female member 230 would need to extend to a
greater height along the vertical axis 234 to accommodate a similar
sized male member.
[0067] The male member 226 has a plurality of indentations 238,
rack cutouts, ratchets, gears, or teeth. A tool, not shown in FIGS.
11-13, has a plurality of corresponding protrusions to engage the
teeth. Rotating the protrusions on the tool acts as a pinion gear
and causes the male member 226 to move up or down along the
vertical axis 228. With reference to FIG. 10D, a tool 1 is shown
attached to the first extension 202. The tool may have an arm 2
that terminates in a protrusion (not shown) that engages a detent
or hole 3 on the first extension 202. A pinion gear may be
contained in a housing 4 to engage the indentations. The pinion
gear may be rotated by a dial (not shown) connected to a handle
distal to the housing 4 using, for example, a worm drive or the
like.
[0068] As seen in FIG. 13, the second part 210 has a central
portion 238 that extends from the anterior facing side 212 to the
posterior facing side 214. Extending in a superior direction from
the central portion 238 is a male member 240. The male member 240
is on the posterior side of the second part 210. The male member
240 has a vertical axis 242 that is substantially aligned with
vertical axis 234 of the female member 230 on the first part 208.
The male member 240 is sized for telescopic movement in and out of
the socket 232. The male member 240 may have surface texturing 243
in a posterior face to engage a set screw, or the like, threaded
into threaded bore 224 (above). Extending in an inferior direction
from the central portion 248 is a female member 244. The female
member 244 generally conforms to the inferior lobes described above
with respect to FIGS. 1-9. The female member 244 is generally
hollow and forms a socket 246. The female member also has a
vertical axis 248 that is substantially aligned with the vertical
axis 228 of the male member 226 of the first part 208. The socket
246 is sized to allow telescopic movement of male member 226 in and
out of the socket 246. The socket 246 forms a through bore in the
female member such that has openings 250 on the top and bottom,
although the bottom opening 250 may be closed within a web of
material.
[0069] A lateral side 252 of the female member 244 has an opening
or window 254. The indentations 238 of the male member 226 are
visible through the window 254. The tool, explained above but not
shown in FIGS. 11-13, has protrusions that extend through the
window 254 to engage the indentations.
[0070] FIGS. 14-17 show implant 200 in a compact state 260. FIG. 13
shows a view along the horizontal axis 201 of the lateral side 252
of the first extension 202. The first part 208 and the second part
210 are shown abutting along an edge 262. The first and second part
208, 210 do not need to abut along the edge 262, but allowing the
first and second parts 208, 210 to abut provides a low profile.
Prior to implantation, the implant 200 may be held assembled in the
compact state 260 using a pin 264 in a pin hole 266 where the pin
264 extends through the female member 230 of the first part 208 and
engages the male member 240 of the second part 210, such as, for
example, by engaging a groove 256. Alternatively, set screw 268
could be threaded into threaded bore 224 to hold the parts
together.
[0071] The female members 230, 244 are shown extending in the
superior and inferior direction, respectively. The male member 222
is shown fully inserted into socket 246 and visible through window
254. The male member 240 is fully inserted into socket 232, but not
visible in the lateral view.
[0072] FIG. 15 shows the first extension 202 from a posterior view
in the compact state 260. In the compact state 260, the first
extension 202 has a height 270. The posterior arms 206p.sub.1 and
206p.sub.2 abut in the compact state 260 to provide a low profile
in the compact state (in other words, the height 270 is as small as
possible), although they could be slightly separated. The first
extension 202, including the plurality of arms, extends in the
horizontal direction a length 272.
[0073] FIG. 16 shows the first extension 202 from a medial view in
the compact state 260. In the compact state 260, the anterior arms
206a.sub.1 and 206a.sub.2 nest such that anterior wall members 276,
277 are in a sliding relationship when in the compact state. The
anterior wall members may be referred to herein as vertical wall
members, anterior flaps, or the like. The posterior arms 206p.sub.1
and 206p.sub.2 abut, but could be designed to nest similar to the
anterior arms 206a.sub.1 and 206a.sub.2. As shown, each of the arms
for a vertical wall and an overhang 278 forming a quasi chamber 280
into which bone growth may occur. Additionally, bone growth
promoting substances may be contained in the chamber 280.
[0074] FIG. 17 shows the first extension 202 from an anterior view
in the compact state 260. As can be appreciated with respect to
FIGS. 17 and 18, where FIG. 18 shows a superior view of the first
extension, the anterior arms 206a.sub.1 and 206a.sub.2 extend from
the medial side 203 a length 282. The anterior arms may terminate
in a chamfered terminal end 283 to facilitate implantation of the
implant 200. Similarly, the posterior arms 206p.sub.1 and
206p.sub.2 extend from the medial side 203 a length 284. As shown,
the length 284 of the posterior arms is longer than the length of
the anterior arms 282 by a distance represented by 286. The shorter
anterior arms facilitate clearing portions of the anatomy, such as
the facet, during certain implantation procedures.
[0075] FIG. 19 shows the first extension 202 in the fully extended
state 288 in both a lateral and posterior view. The first extension
202 in the extended state 288 has a maximum height 290 greater than
the height 270 in the compact state. The extended state 288 may be
referred to as the distracted or distraction state. As can be
appreciated, the first extension 202 may be moved from the compact
state 260 to an extended state where the height is less than the
maximum height 290 shown in FIG. 19. The set screw 268 engaging the
texture 243 holds the first part 208 and the second part 210 in
position once the position is set by the surgeon.
[0076] The first extension 202 provides dual male-female
telescoping members as described above. The dual telescoping
members allow for the plate to substantially change height while
maintaining a sufficient aspect ratio to reduce frictional binding
during actuation and also to increase rigidity of the final
construct. In some embodiments, the male-female telescoping pairs
are arranged so that the female member of each telescoping feature
is positioned offset so that the male member of each telescoping
feature fully resides inside the member, with no protrusions in the
compact state. Such an arrangement prevents or helps prevent
interference when nesting additional plates at the adjacent levels
for multilevel use. In some embodiments, two implants are used to
connect across or collectively span two adjacent interspinous
spaces. In other embodiments, three or more implants are used to
connect across three or more interspinous spaces. Additionally, it
can be appreciated now that the male members and the female members
may be reversed and the above description including lateral,
medial, superior, inferior, anterior, and posterior directions or
guides is to facilitate identification of different pieces and
parts of the device and should not be considered limiting.
[0077] With reference back to FIGS. 10A-D, the second extension
204, which is sometimes referred to as the lock plate, comprises a
third part 300 and a fourth part 302, both of which are shown in a
lateral view along horizontal axis 201 in FIG. 20. The third part
300 and fourth part 302 similar to the first part 202 and second
part 204 have an anterior facing side 212 and a posterior facing
side 214. As shown, third part 300 includes a pin hole 301 that
receives a pin 303. As will be explained below, the pin 303 extends
through pin hole 301 and loosely couples the third part 300 and the
fourth part 302.
[0078] FIG. 21 shows an anterior, lateral perspective view of the
third part 300. The third part 300 includes a central portion 304
with a posterior, female member 306 extending in a superior
direction from the central portion 304. The female member 306
generally conforms to a superior lobe of the section extension
described above with respect to FIGS. 1-9. The female member 306 is
generally hollow forming socket 308 and has a vertical axis 310.
The central portion 304 of the third part 300 includes a threaded
bore 312 that receives a set screw 314 to lock the third part 300
to the fourth part 302, as will be explained further below.
[0079] An anchor 316 or truncated male member extends in an
inferior direction from the central portion 304, As shown in FIG.
22, the anchor 316 has a short post 318 that terminates in a
flanged surface 320. The central portion 304, post 318, and flanged
surface 320 form a first interior cavity 322. With reference back
to FIG. 16, for example, the first cavity 322 is shaped to
cooperatively, and slidingly, engage the posterior arm 206p.sub.1,
which includes the overhang 278. Similarly, the central portion
304, post 318, and flanged surface 320 form a first exterior cavity
324, which may be sometimes referred to as a carve out or groove.
The first exterior cavity 324 is shaped to cooperatively, and
slidingly, engage the overhang 278 of the anterior arm 206a.sub.1.
As can be appreciated, the more snugly the cavities 322 and 324 fit
the arms 206p.sub.1 and 206a.sub.1, the less movement is provided.
Increasing the size of the cavities may provide the ability to
orient the third part 300 with respect to the patient anatomy. In
the embodiment shown, the cavities are provided with an angled or
chamfered surface 321 that provides the ability to adjust the angle
of the third part in the coronal plane. The angle may be from about
0.degree. degrees to about 10.degree. or in some cases
15.degree..
[0080] With reference now to FIG. 23, a view of the fourth part 302
is shown. The fourth part comprises a central portion 326. A
posterior, male member 328 extends in a superior direction
posterior facing side of the central portion 326. The male member
328 extends along a vertical axis 330. The vertical axis 330 of the
male member 328 generally aligns with the vertical axis 310 of the
socket 308 or female member 306. The male member 328 is sized for
telescopic movement in and out of the socket 308. The male member
328 may include a channel. An anterior member 332 extends in an
inferior direction from the central portion.
[0081] An anchor 334, generally corresponding in size, form, and
function to the anchor 316 above, extends in a superior direction
from the central portion 326 as best seen in FIG. 24. The anchor
334 includes a short post 336 that terminates in a flanged surface
338. The central portion 326, post 336, and flanged surface 338
form a second interior cavity 340. With reference back to FIG. 16,
for example, the second cavity 340 is shaped to cooperatively, and
slidingly, engage the posterior arm 206p.sub.2, which includes the
overhang 278. Similarly, the central portion 326, post 336, and
flanged surface 338 form a second exterior cavity 342, which may be
sometimes referred to as a carve out or groove. The second exterior
cavity 342 is shaped to cooperatively, and slidingly, engage the
overhang 278 of the anterior arm 206a.sub.2. As can be appreciated,
the more snugly the cavities 340 and 342 fit the arms 206p.sub.2
and 206a.sub.2, the less movement is provided. Increasing the size
of the cavities, may provide the ability to orient the fourth part
302 with respect to the patient anatomy. Similar to the cavities
above, the cavities are provided with an angled or chamfered
surface 321 that provides the ability to adjust the angle of the
third part in the coronal plane. The angle may be from about
0.degree. degrees to about 10.degree. or in some cases 15.degree..
Notice, the anterior arms and the posterior arms are each similarly
shaped such that the first and second internal cavities, and the
first and second external cavities, all have generally the same
shape.
[0082] The posterior face 344 of the male member 328 includes
surface texturing 243 similar to the posterior face of male member
240 described above. Thus, when the male member 328 is telescoped
in female socket 308 to a desired position, the set screw 314 may
be threaded in threaded bore 312 until the set screw engages the
surface texturing 243 to secure the third part 300 with respect to
the fourth part 302.
[0083] The anterior member 332, while hollow, does not form a
socket similar to the other members described herein; in part,
because third part 302 has an anchor 316 rather than a male member
extending from the third part 300 in an inferior direction. Also,
anterior member 332, which is shown in cross-section in FIG. 25,
provides a means for coupling the second extension 204 to the
plurality of arms 206, and more specifically, to the posterior arm
206p.sub.2 in this exemplary embodiment. As shown, anterior member
332 provides an elongate chamber 346 that has a posteriorly
extending tool port 348 arranged in this embodiment below central
portion 326. The elongate chamber 346 extends from the bottom of
anterior member 332 to the flanged surface 338. The short post 336
has a posterior port 350 which is shown extending completely
through short post 336 of anchor 334, but is only needed to extend
from the elongate chamber 346 to the second internal cavity 340. A
plunger 352 resides in the posterior port 350. The plunger 352
couples to the posterior arm 206p.sub.2 to hold the second
extension 204 in place during the surgical procedure. In this
exemplary embodiment, the plunger 352 may be considered a ratcheted
plunger as the plunger 352 has a plurality of teeth 354 that engage
corresponding teeth 356 (FIG. 18) on the posterior arm 206p.sub.2.
The plunger is coupled to a spring arm 360, such as, by the spring
arm 360 extending into a bore 358. The spring arm 360 biases the
plunger in a posterior direction such that the plunger extends from
the posterior port 350 to engage the posterior arm 206p.sub.2. As
can be appreciated, the teeth are shaped to allow movement of the
second extension toward the first extension without disengaging the
plunger 352. However, to move the second extension away from the
first extension, a tool needs to extend into tool port 348 to
engage spring arm 360. The tool would move spring arm 360 in an
anterior direction to allow the plunger 352 to disengage such that
the second extension may be moved away from the first extension.
FIG. 27 shows a view of the teeth 354 of the plunger 352 extending
through posterior port 350 into the second internal cavity 340.
[0084] FIG. 28 shows a cross sectional view of the plurality of
arms 206 including the anterior arms 206a.sub.1 and 206a.sub.2, and
the posterior arms 206p.sub.1 and 206p.sub.2. Each of the arms has
an overhang 278. The four arms, in this exemplary embodiment, form
a quasi-chamber 280 into which tissue growth or bone growth
material may be placed to facilitate fusion. Also, the plurality of
arms 206, as well as the first and second 202, 204 extension may
include surface texturing, roughing, plasma coating, or the like to
facilitate tissue and bone growth. Further, as mentioned above,
more or less arms 206 are possible such as, for example, a midline
arm 206m.sub.1 and 206m.sub.2 as shown in phantom. Additionally,
the posterior arms 206p.sub.1 and 206p.sub.2 comprise a main body
362 from which the overhang 278 extends. The anterior arms
206a.sub.1 and 206a.sub.2 have an anterior wall member 364 from
which the overhang 278 extends. The anterior wall member may
comprise different heights, as shown in phantom, from about two (2)
millimeters to about eight (8) millimeters. The anterior wall
members 364 together form a larger anterior wall to facilitate
retention of any tissue or bone growth material placed in
quasi-chamber 280. As can be appreciated, the smaller anterior wall
members 364 of approximately 2 mm would be used in smaller
applications of the present technology, such as, for the cervical
spine space; whereas, the larger anterior wall members 364 of
approximately 8 mm would be used in larger applications of the
present technology, such as the lumbar spine space. The anterior
wall members 364 could have heights of three (3), four (4), five
(5), six (6), seven (7) or even up to about ten (10) millimeters
depending on the application. As can be appreciated, in the compact
state, the anterior wall members substantially abut or overlap. As
the implant is expanded or distracted, the anterior wall members
slidingly move against each other to the expanded state.
[0085] Alternatively, as shown in FIG. 29, a floating wall 366 may
be provided between the anterior wall members 364. The floating
wall 366 is slidingly and moveably coupled to one or both of the
anterior wall members 364. Additionally, while only one floating
wall 366 is shown, multiple floating walls 366 may be layered to
provide different extension lengths. In one exemplary embodiment,
the floating wall 366 may have a tongue 368 with a flare 370 that
engages a groove 372 and stop 374 on the anterior wall members 364,
as shown partially exploded in FIG. 30.
[0086] As mentioned above, once distracted, the first and third
parts 208, 300 may be locked to the male members 240, 328, of the
second and fourth parts 210, 302 of the implant 200. In the
exemplary embodiment provided, set screws 268, 314 are threaded
into threaded bores 224, 314 respectively. An exemplary set screw
376 is shown in FIGS. 31 and 32. The set screw 376 has a threaded
body 378 that cooperatively engages the threads of threaded bores
224, 314. The set screw 376 also has, in this exemplary embodiment,
a non-threaded tip 380 that terminates in an edge 382, which is
circular in this embodiment. The set screw 376 may have an internal
bore 384 adapted to engage a driver (not shown). The bore 384 may
have a number of undulations 386 or the like to facilitate
engagement with the driver, such as a hex driver, hexalobular, star
driver, or the like. The set screw 376 is shown in cross-section in
FIG. 33. The edge 382 of the set screw 376 engages the surface
texturing 243 on the male members 240, 328 to form a cup point
connection as is generally known in the industry. To facilitate the
cup point connection, the surface texturing may be scooped, or dual
crescent, shaped to match the curvature of the edge 382.
[0087] Some exemplary tools and instruments usable with the implant
200 will be shown and described with reference to the remaining
FIGS. While some tools are specifically shown, it should be
understood that other and different tools may be used to accomplish
many of the functions of the technology of the present
application.
[0088] A driver 400 may be provided as shown in FIG. 34. The driver
400 has a shaft 402 with a proximal end 404 and a distal end 406.
The distal end 406 may terminate in a tip 408, such as, for
example, a conventional hex or star shape, to cooperatively engage
the bore 384 of the set screws. The proximal end 402 may be sized
and designed to facilitate rotation of the driver by hand.
[0089] A compressor 410 may be provided as shown in FIG. 35. The
compressor 410 includes two members 412 pivotally connected. The
pivotal connection 414 may comprise a pin 416, or axle, coupling
the two members 412 together. Each of the members 412 has a handle
or grip 418 at a proximal end 420 of the compressor 410 and a tip
422 at the distal end 424 of the compressor. The grips are biased
apart by springs 426, such as, for example, leaf springs. When the
grips 418 are compressed together against the springs 426, the tips
422 compress the first and second extensions 202, 204 together. A
lock bar 428 maintains the grips 418 in the compressed state until
the lock bar is manually lifted, at which time the springs open the
compressor 410. The tips may be textured to facilitate gripping the
first and second extensions. As can be appreciated, multiple
compressors 410 may be required for smooth compression of the
multiple parts of the first and second extensions.
[0090] With reference now to FIGS. 36 and 37, a combination
inserter and expander tool 450 is provided. FIG. 36 shows a view of
the tool 450 and FIG. 37 shows a cross-sectional view of the tool
450. The tool 450 has a proximal end 452 with an enlarged grip 454
to improve the surgeon's ability to grip the tool 450; however, the
grip 454 does not need to be enlarged. The tool also has a distal
end 456 for connection to the implant 200, as will be explained
further below. The distal end 456 is adapted to be moved from
outside the body of a patient to the surgical site. The handle or
grip 454 is connected to a shaft nut 462 that is connected to the
shaft 460. The shaft 460 terminates in a tip 458.
[0091] The grip 454 terminates at an end 461 that may include a
display face 462. The display face 462 may have indicia 463
corresponding to the distraction to be provided to the spinous
processes. The display face 462 and indicia are coupled to a
proximal end of a drive axle 464. The drive axle 464 extends along
a longitudinal axis 466 of the tool 450 from the proximal end to
the tip 458 at the distal end 456. The proximal end of the drive
axle 464 is coupled to a worm gear 468 such that rotation of the
worm gear 468 rotates the drive axle 464. The worm gear 468 meshes
with a threaded portion 470 (worm) of a transverse axle 472 having
a transverse axis 474 that is perpendicular to the longitudinal
axis 466. The transverse axle 474 extends through a bore 476
towards the end of the grip 454. As shown, each end of the
transverse axle 474 terminates in rotatable tabs 478, which may be
thumb wheels or the like. Rotation of the tabs 478 causes the worm
gear 468 to rotate, which in turn rotates the drive axle 464 and
the display face 462. A pinion gear 480 contained in the tip 458
has teeth 482 that mesh with the indentations 238 or rack cutouts
to drive the male member into or out of the associated female
member.
[0092] FIG. 39 shows the tip 458 in more detail without the pinion
gear 480 or the drive axle 464. The tip 458 may include a removable
cap 484 such that the pinion gear 480 may be replaced or
refurbished as required. The tip 458 further has an engagement
detent 486. The engagement detent 486 couples to an inserter tool
bore 488 (FIG. 10A) such that the tool 450 may be releasably
coupled to the implant 200. While the engagement detent 486 may
form a 90.degree. angle with respect to the longitudinal axis 466,
the engagement detent 486 may be angled slightly towards the
proximal end of the tool 450 such that the engagement detent 486
extends at an acute angle a in the posterior direction. The acute
angle a provides a better connection between the tool 450 and the
implant 200.
[0093] In certain applications, the implant 200 may be partially
assembled exterior to a patient prior to implantation. In other
cases, the first extension 202 and the plurality of arms 206 may be
implanted first and the second extension 204 inserted subsequent to
the arms being extended through the interspinous space. To
facilitate movement of the second extension 204, a second extension
inserter 500 is provided as shown in FIG. 40. Inserter 500 includes
a pistol grip 502 comprising a post 504 and a movable trigger 506.
The moveable trigger 506 is biased away from the post 504 by a pair
of cooperating springs 508, such as, for example, leaf springs.
Extending along a longitudinal axis is a stationary shaft 510
coupled to post 504. The shaft 510 is called the stationary shaft
as it does not move relative to the post 504. A movable shaft 512
is slidingly coupled to the stationary shaft and the trigger 506.
Moving the trigger 506 towards the post 504 in a direction A about
the pivot axle 514 causes the movable shaft 512 to move in a
direction B relative to the stationary shaft 510. A lock 516, such
as the shown thumb lock, may be moved into place to maintain the
tool in the grip position against the springs 508.
[0094] The movable shaft 512 has a tip 522 that extends into the
posteriorly extending tool port 348, which may bias the spring arm
360 to disengage the plunger 352 from posterior arm 206p.sub.2 and
allow movement of the second extension 204 away from the first
extension 202. In this manner, the second extension 204 may be
translated relative to the first extension 202 without ratcheting.
The ratchets may then be reengaged by removing tip 522 from port
348 to help secure the second extension 204 at the desired time or
location. The stationary shaft 510 has a protrusion 518 that
engages an opening or detent on the lateral surface of the second
extension 204 to help retain shaft 510 thereto.
[0095] A housing 520 is coupled to the movable shaft 512 a distance
d along the movable shaft 512 from a tip 522. The housing 520
contains a compression member 524, such as a spring. Extending from
the housing 520 toward the tip 522 is an arm 526, wherein the
spring and arm may be considered a spring loaded arm. The arm 526
has a flanged gripping surface 528 to provide a frictional gripping
force when the trigger 506 is moved towards the post 504 such that
the tool 500 can grip the second extension 204.
[0096] As herein, "about" refers to a degree of deviation based on
experimental error typical for the particular property identified.
The latitude provided the term "about" will depend on the specific
context and particular property and can be readily discerned by
those skilled in the art. The term "about" is not intended to
either expand or limit the degree of equivalents which may
otherwise be afforded a particular value. Further, unless otherwise
stated, the term "about" shall expressly include "exactly,"
consistent with the discussions regarding ranges and numerical
data. Concentrations, amounts, and other numerical data may be
expressed or presented herein in a range format. It is to be
understood that such a range format is used merely for convenience
and brevity and, thus, should be interpreted flexibly to include
not only the numerical values explicitly recited as the limits of
the range, but also to include all the individual numerical values
or sub-ranges encompassed within that range as if each numerical
value and sub-range is explicitly recited. As an illustration, a
numerical range of "about 4 percent to about 7 percent" should be
interpreted to include not only the explicitly recited values of
about 4 percent to about 7 percent, but also include individual
values and sub-ranges within the indicated range. Thus, included in
this numerical range are individual values such as 4.5, 5.25 and 6
and sub-ranges such as from 4-5, from 5-7, and from 5.5-6.5; etc.
This same principle applies to ranges reciting only one numerical
value. Furthermore, such an interpretation should apply regardless
of the breadth of the range or the characteristics being
described.
[0097] Notwithstanding that the numerical ranges and parameters
setting forth the broad scope of the invention are approximations,
the numerical values set forth in the specific examples are
reported as precisely as possible. Any numerical value, however,
inherently contain certain errors necessarily resulting from the
standard deviation found in their respective testing
measurements.
[0098] It will be clear that the systems and methods described
herein are well adapted to attain the ends and advantages mentioned
as well as those inherent therein. Those skilled in the art will
recognize that the methods and systems within this specification
may be implemented in many manners and as such is not to be limited
by the foregoing exemplified embodiments and examples. In other
words, functional elements being performed by a single or multiple
components, in various combinations of hardware and software, and
individual functions can be distributed among software applications
at either the client or server level. In this regard, any number of
the features of the different embodiments described herein may be
combined into one single embodiment and alternate embodiments
having fewer than or more than all of the features herein described
are possible.
[0099] While various embodiments have been described for purposes
of this disclosure, various changes and modifications may be made
which are well within the scope of the present invention.
[0100] Numerous other changes may be made which will readily
suggest themselves to those skilled in the art and which are
encompassed in the spirit of the disclosure.
* * * * *