U.S. patent application number 13/267869 was filed with the patent office on 2012-02-02 for compliant interbody fusion device with deployable bone anchors.
This patent application is currently assigned to CUSTOM SPINE, INC.. Invention is credited to Mahmoud F. Abdelgany, Aaron D. Markworth, Young Hoon Oh.
Application Number | 20120029644 13/267869 |
Document ID | / |
Family ID | 42223524 |
Filed Date | 2012-02-02 |
United States Patent
Application |
20120029644 |
Kind Code |
A1 |
Markworth; Aaron D. ; et
al. |
February 2, 2012 |
Compliant Interbody Fusion Device with Deployable Bone Anchors
Abstract
An interbody fusion implant with deployable bone anchors
includes a support member, a monolithic body that accommodates the
support member, and a longitudinal hole along a vertical length of
the support member. The support member includes a first end and a
second end. The second end includes two flanges. The flanges are
configured to dig into an endplate of a vertebral body. The flanges
of the support member provide a location fixation on an
implantation of the interbody fusion implant into the vertebral
body. The support member may also include at least one of a clip
shaped support member and an I-shaped support member. The I-shaped
support member may allow a rigidity and a support in
flexion-extension through a living-hinge positioned in a middle of
the I-shaped support member. The longitudinal hole sustains loads
imported on the interbody fusion implant and allows the interbody
fusion implant to flex freely.
Inventors: |
Markworth; Aaron D.; (Saddle
Brook, NJ) ; Oh; Young Hoon; (Montville, NJ) ;
Abdelgany; Mahmoud F.; (Rockaway, NJ) |
Assignee: |
CUSTOM SPINE, INC.
Parsippany
NJ
|
Family ID: |
42223524 |
Appl. No.: |
13/267869 |
Filed: |
October 6, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
12326079 |
Dec 1, 2008 |
8062374 |
|
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13267869 |
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Current U.S.
Class: |
623/17.16 |
Current CPC
Class: |
A61F 2002/30523
20130101; A61F 2002/30904 20130101; A61F 2002/30476 20130101; A61F
2/447 20130101; A61F 2220/0033 20130101; A61F 2002/30594 20130101;
A61F 2002/30593 20130101; A61F 2220/0025 20130101; A61F 2002/30841
20130101; A61F 2002/30772 20130101; A61F 2002/30579 20130101; A61F
2002/4627 20130101; A61F 2002/30576 20130101; A61F 2/4611 20130101;
A61F 2002/30364 20130101 |
Class at
Publication: |
623/17.16 |
International
Class: |
A61F 2/44 20060101
A61F002/44 |
Claims
1. An interbody fusion implant with deployable bone anchors
comprising: a support member having a first end and a second end,
said second end comprising two flanges, said flanges configured to
dig into an endplate of a vertebral body, wherein said support
member comprises at least one of a clip shaped support member and
an I-shaped support member; a monolithic body that accommodates
said support member; and a longitudinal hole along a vertical
length of said support member, wherein said longitudinal hole
sustains loads imported on said interbody fusion implant and allows
said interbody fusion implant to flex freely.
2. The interbody fusion implant of claim 1, wherein said flanges of
said support member provide a location fixation on an implantation
of said interbody fusion implant into said vertebral body.
3. The interbody fusion implant of claim 1, wherein said I-shaped
support member allows a rigidity and a support in flexion-extension
through a living-hinge positioned in a middle of said I-shaped
support member.
4. The interbody fusion implant of claim 1, wherein said I-shaped
support member is cut in a front and a side plane to enable two
degrees of freedom and to bend in at least one of a sagital and a
transverse plane.
5. The interbody fusion implant of claim 1, wherein said interbody
fusion implant is inserted in at least one of anteriorly,
posteriorly, or transforaminal in said vertebral body.
6. The interbody fusion implant of claim 1, wherein a cephalad and
a caudal surface of said interbody fusion implant is molded with
surface finishes to provide an additional fixation with said
endplate of said vertebral body, and wherein said surface finishes
comprises at least one of teeth, geometry, and serrations.
7. The interbody fusion implant of claim 6, wherein said geometry
provides an ease of attachment and flexibility in said vertebral
body.
8. An apparatus to stabilize a human spine, said apparatus
comprising: a compliant monolithic interbody fusion implant
comprising: at least one support member comprising at least one rod
that is rotated with a driving instrument; a plurality of spikes
attached to said rod, wherein said plurality of spikes are
symmetric and perpendicular to a main axis of said rod; a
monolithic complaint body that accommodates said rod and said
spikes; at least one window molded in said monolithic complaint
body, wherein said window rotates said rod from a horizontal to a
vertical configuration; and an inserter tool that inserts said
compliant monolithic interbody fusion implant into said human
spine.
9. The apparatus of claim 8, wherein said plurality of spikes
penetrate endplates of vertebral bodies in said human spine to fix
said monolithic compliant body in place in a vertical
configuration.
10. The apparatus of claim 8, further comprising a plurality of
rods, wherein each rod comprises at least two spikes, said spikes
being positioned perpendicular to the main axis of said rod, and
wherein said rod rotates from a vertical to a horizontal
configuration.
11. The apparatus of claim 10, wherein said plurality of rods are
positioned within said monolithic compliant body to form a cephalad
and caudal set.
12. The apparatus of claim 10, wherein said plurality of rods
comprises at least one gear at a proximal end of each rod to drive
and rotate said rod from a horizontal to vertical position.
13. The apparatus of claims 12, wherein said plurality of rods and
said at least one gear are positioned and timed to each other with
a corresponding female beveled gear to deploy said plurality of
rods and said at least one gear with a one turn motion.
14. The apparatus of claim 8, wherein said inserter tool comprises
a protrusion that accommodates said at least one gear.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] This application is a divisional of U.S. patent application
Ser. No. 12/326,079 filed on Dec. 1, 2008, the contents of which,
in its entirety, is herein incorporated by reference.
BACKGROUND
[0002] 1. Technical Field
[0003] The embodiments herein generally relate to spinal
stabilization devices, and more particularly to a compliant
interbody fusion device with deployable bone anchors.
[0004] 2. Description of the Related Art
[0005] Conventional spinal fusion implants typically having
projections that can be deployed after the implant has been
inserted into the disc space and are used to stabilize the human
spine. A problem with the conventional spinal fusion implants is
that they are static in size. This poses various problems with
their use and/or implantation. As a result, nerves may become
pinched, causing pain that radiates into other parts of the body
and instability in the vertebrae.
[0006] To overcome this, spinal decompression and fusion procedures
can be augmented with bone or implants being inserted between the
vertebral bodies and held in place with pedicle screws. This
disrupts the normal biomechanics of the spine while correcting the
instability. Fusion, while correcting the instability, can also
cause adjacent disc disease. Also, generally the conventional
interbody designs are non-complaint or do not have deployable bone
anchors that can be opened after insertion to aid ease of
implantation.
[0007] These standard devices are also more prone to subsidence and
may contribute to adjacent disc disease. Moreover, these devices
generally do not help in restoring the normal biomechanics of the
thoraco-lumbar spine. In conjunction with a dynamic rod/screw
system or stand-alone, the device may not reduce the chances of
adjacent disk disease.
SUMMARY
[0008] In view of the foregoing, an embodiment herein provides an
interbody fusion implant with deployable bone anchors including a
support member having a first end and a second end, the second end
including two flanges, the flanges are configured to dig into an
endplate of a vertebral body. The interbody fusion implant further
includes a monolithic body that accommodates the support member,
and a longitudinal hole along a vertical length of the support
member. The longitudinal hole sustains loads imported on the
interbody fusion implant and allows the interbody fusion implant to
flex freely.
[0009] The support member includes at least one of a clip shaped
support member and an I-shaped support member. The flanges of the
support member may provide a location fixation on an implantation
of the interbody fusion implant into the vertebral body. The
I-shaped support member allows rigidity and a support in
flexion-extension through a living-hinge positioned in a middle of
the I-shaped support member. The I-shaped support member is cut in
a front and a side plane to enable two degrees of freedom and to
bend in at least one of a sagital and a transverse plane.
[0010] The interbody fusion implant may be inserted in at least one
of anteriorly, posteriorly, or transforaminal in the vertebral
body. A cephalad and a caudal surface of the interbody fusion
implant is molded with surface finishes to provide an additional
fixation with the endplate of the vertebral body and the surface
finishes includes at least one of teeth, geometry, and serrations.
The geometry may provide an ease of attachment and flexibility in
the vertebral body.
[0011] Another embodiment provides an apparatus to stabilize a
human spine. The apparatus includes a compliant monolithic
interbody fusion implant including at least one support member
having at least one rod that is rotated with a driving instrument,
a plurality of spikes attached to the rod, a monolithic complaint
body that accommodates the rod and the spikes, at least one window
molded in the monolithic complaint body, and an inserter tool that
inserts the compliant monolithic interbody fusion implant into the
human spine.
[0012] The window rotates the rod from a horizontal to a vertical
configuration. The plurality of spikes penetrate endplates of
vertebral bodies in the human spine to fix the monolithic compliant
body in place in a vertical configuration. The plurality of spikes
are preferably symmetric and perpendicular to a main axis of the
rod. The apparatus may further include a plurality of rods. Each
rod including at least two spikes. The spikes are positioned
perpendicular to the main axis of the rod and the rod rotates from
a vertical to a horizontal configuration.
[0013] The plurality of rods are positioned within the monolithic
compliant body to form a cephalad and caudal set. The plurality of
rods may include at least one gear at a proximal end of each rod to
drive and rotate the rod from a horizontal to vertical
position.
[0014] The plurality of rods and the gear are positioned and timed
to each other with a corresponding female beveled gear to deploy
the plurality of rods and the gear with a one turn motion. The
inserter tool includes a protrusion that accommodates the gear.
[0015] Yet another embodiment provides an interbody fusion assembly
for attachment to endplates of vertebral bodies. The interbody
fusion assembly includes a tube including at least one hole, the
tube including a camshaft, a plurality of cams coupled to the
camshaft, and a plurality of free moving spikes coupled to the cams
along a perpendicular axis to the camshaft, and a complaint
monolithic body that accommodates the tube. The free moving spikes
are positioned in a vertical orientation and set within the tube.
The plurality of cams force the free moving spikes upward into the
endplates of the vertebral bodies upon rotation of the camshaft.
The free moving spikes may cut at least partially through the
complaint monolithic body.
[0016] The free moving spikes penetrate the endplates to fix the
complaint monolithic interbody fusion assembly in place upon
rotation of the camshaft. A plurality of holes may be molded into
the complaint monolithic body to allow passage of the free moving
spikes. A cephalad and a caudal surface of the complaint monolithic
body is molded with surface finishes to provide fixation with the
endplates. The surface finishes include at least one of teeth,
geometry, and serrations.
[0017] These and other aspects of the embodiments herein will be
better appreciated and understood when considered in conjunction
with the following description and the accompanying drawings. It
should be understood, however, that the following descriptions,
while indicating preferred embodiments and numerous specific
details thereof, are given by way of illustration and not of
limitation. Many changes and modifications may be made within the
scope of the embodiments herein without departing from the spirit
thereof, and the embodiments herein include all such
modifications.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] The embodiments herein will be better understood from the
following detailed description with reference to the drawings, in
which:
[0019] FIGS. 1A and 1B illustrate perspective views of a compliant
monolithic spinal fusion implant according to a first embodiment
herein;
[0020] FIGS. 2A and 2B illustrate perspective views of a compliant
monolithic spinal fusion implant according to a second embodiment
herein;
[0021] FIGS. 3A and 3B illustrate perspective views of a compliant
monolithic spinal fusion implant according to a third embodiment
herein;
[0022] FIGS. 4A and 4B illustrate perspective views of a compliant
monolithic spinal fusion implant and an inserter tool according to
a fourth embodiment herein;
[0023] FIGS. 5A and 5B illustrate perspective views of a compliant
monolithic spinal fusion implant according to a fifth embodiment
herein; and
[0024] FIG. 5C illustrates a sectional view of a compliant
monolithic spinal fusion implant according to a fifth embodiment
herein.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0025] The embodiments herein and the various features and
advantageous details thereof are explained more fully with
reference to the non-limiting embodiments that are illustrated in
the accompanying drawings and detailed in the following
description. Descriptions of well-known components and processing
techniques are omitted so as to not unnecessarily obscure the
embodiments herein. The examples used herein are intended merely to
facilitate an understanding of ways in which the embodiments herein
may be practiced and to further enable those of skill in the art to
practice the embodiments herein. Accordingly, the examples should
not be construed as limiting the scope of the embodiments
herein.
[0026] The embodiments herein provide a compliant material
monolithic spinal fusion device for spinal stabilization. The
embodiments herein provide an I-shaped support member of a spinal
fusion implant that allows more rigidity and support through the
middle of the device and act as a living-hinge in
flexion-extension, enables two degrees of freedom, acting as a
joint that can bend in both the sagital and transverse planes.
[0027] The compliant material monolithic spinal fusion device aids
in restoring the normal biomechanics of the thoraco-lumbar spine.
In conjunction with a dynamic rod/screw system or stand-alone, the
device reduces the chances of adjacent disk disease. Referring now
to the drawings and more particularly to FIGS. 1A through 5C where
similar reference characters denote corresponding features
consistently throughout the figures, there are shown preferred
embodiments.
[0028] FIGS. 1A and 1B illustrate a perspective view of a compliant
monolithic spinal fusion implant 100 according to a first
embodiment herein. With reference to FIGS. 1A and 1B, the compliant
monolithic spinal fusion implant 100 includes a compliant
monolithic body 102, a support member 104, a longitudinal hole 106
along the vertical length of the support member 104, and flanges
108 located near the opening of the hole 106. The compliant
monolithic spinal fusion implant 100 may be inserted anteriorly,
posteriorly, or transforaminal in between vertebral bodies of the
spine.
[0029] The longitudinal hole 106 along the vertical length of the
clip shaped support member 104 enables the support member 104 to
sustain a heavy load and flex freely. A cephalad and a caudal
surface of the compliant monolithic spinal fusion implant 100 may
be molded with a surface finish (e.g., teeth, geometry, or
serrations) to provide an additional fixation with endplates (not
shown). In one embodiment, the support member 104 is embodied as a
clip shaped support member. In another embodiment, the geometry of
the support member 104 provides flexibility and can be squeezed
shut for a minimal profile during an insertion and ease of
attachment to an insertion tool (not shown).
[0030] When the insertion tool (not shown) is removed, the support
member 104 may spring open to support the vertebral bodies. The
flanges 108 on the end of the support member 104 may dig into the
endplates to provide a location fixation. The compliant monolithic
spinal fusion implant 100 may be inserted or impacted by means of
the inserter tool (not shown).
[0031] In a preferred mode, the inserter tool (not shown) includes
a shaft of an adequate length. One end of the inserter tool (not
shown) may include a protrusion attached to the compliant
monolithic spinal fusion implant 100 via a snap fitting around the
flanges 108 of the support member 104. The opposite end of the
inserter tool (not shown) may include a handle with an impact
surface. When the compliant monolithic spinal fusion implant 100 is
loaded, the inserter tool (not shown) is lightly impacted, the
compliant monolithic spinal fusion implant 100 may get wedged
between the vertebral bodies, slightly decompress them and provide
support surfaces for proper biomechanical movement of the
spine.
[0032] FIGS. 2A and 2B illustrate a perspective view of a compliant
monolithic spinal fusion implant 200 according to a second
embodiment herein. The compliant monolithic spinal fusion implant
200 includes a compliant monolithic body 202, a support member 204,
a longitudinal hole 206 along the vertical length of the I-shaped
support member 204, and flanges 208. The support member 204 may
allow more rigidity and support through the middle of the support
member 204 which acts as a living-hinge in flexion-extension.
[0033] In one embodiment, the support member 204 is an I-shaped
support member. The support member 204 may also be cut in both the
front and side planes to allow two degrees of freedom, acting as a
joint that can bend in both the sagital and transverse planes. The
longitudinal hole 206 along the vertical length of the support
member 204 may enable the support member 204 to sustain a heavy
load and flex freely. The flanges 208 on the end of the support
member 204 may dig into endplates (not shown) to provide a location
fixation.
[0034] FIGS. 3A and 3B illustrate a perspective view of a compliant
monolithic spinal fusion implant 300 according to a third
embodiment herein. The compliant monolithic spinal fusion implant
300 includes a compliant monolithic body 302, a rod 304 longitude
to the compliant monolithic body 302 with a plurality of symmetric
spikes 306, and windows 308. The rod 304 is insert-molded in the
compliant monolithic body 302. The spikes 306 are attached to the
rod 304 perpendicular to the main axis of the rod 304.
[0035] The windows 308 are molded in the compliant monolithic body
302 to enable the rod 304 to rotate from a horizontal to a vertical
configuration. In the vertical configuration, the spikes 306
penetrate the end plates (not shown) to fix the compliant
monolithic body 302 in place. The rod 304 may be rotated with an
appropriate driving instrument (not shown).
[0036] FIGS. 4A and 4B illustrate a perspective view of a compliant
monolithic spinal fusion implant 400 and an inserter tool 412
according to a fourth embodiment herein. The compliant monolithic
spinal fusion implant 400 includes a compliant monolithic body 402
and a plurality (e.g., four) separate rods 404. Each of the rods
404 includes one set of spikes 406 and gears 408. The rods 404 are
insert-molded into the compliant monolithic body 402 and have the
ability to rotate from a horizontal to a vertical
configuration.
[0037] The rods 404 are positioned within the compliant monolithic
body 402 so as to have a cephalad and a caudal set. The spikes 406
are attached to the rod 404 perpendicular to the main axis of the
rods 404. The gears 408 are positioned along the main, longitudinal
axis of the rods 404. The gears 408 at the proximal end of the rods
404 enables the ability to drive and rotate the rods 404 from a
horizontal to a vertical position. In one embodiment, the rods 404
are positioned and the gears 408 timed to each other so that a
single driving instrument 412 with female beveled gears 410 may
deploy them simultaneously with one turn motion. The inserter tool
412 is used to insert the compliant monolithic spinal fusion
implant 400 into the vertebral bodies of the spine.
[0038] One end of the inserter tool 412 has a protrusion 410 to
receive the gears 408 of the rods 404 attached to the compliant
monolithic body 402. The opposite end of the inserter tool 412 has
a handle with an impact surface. When the compliant monolithic
spinal fusion implant 400 is loaded in the inserter tool 412 and
inserted, the compliant monolithic spinal fusion implant 400 gets
wedged between the vertebral bodies, slightly decompress them and
provide support surfaces for proper biomechanical movement of the
spine.
[0039] FIGS. 5A and 5B illustrate a perspective view of a compliant
monolithic spinal fusion implant 500 according to a fifth
embodiment herein. FIG. 5C illustrates a sectional view of a
compliant monolithic spinal fusion implant 500 according to a fifth
embodiment herein. The compliant monolithic spinal fusion implant
500 includes a compliant monolithic body 502, a tube 504, a
camshaft 506, cams 508, and a plurality of free moving spikes 510.
The cams 508 are attached to the camshaft 506.
[0040] The camshaft 506 and the spikes 510 are insert molded into
the compliant monolithic body 502 and positioned in a vertical
orientation and set within the tube 504 with holes. The tube 504
acts as housing for the camshaft 506. In one embodiment, when the
camshaft 506 is rotated, the cams 508 force the spikes 510 upward
into the endplates (not shown) of the vertebral bodies, fixing the
compliant monolithic spinal fusion implant 500 in place. In another
embodiment, the spikes 510 may have to cut their way through the
compliant monolithic body 502 or there may be holes molded into the
compliant monolithic body 502 to allow easier passage.
[0041] The embodiments herein provide a compliant material
monolithic spinal fusion implant that may be inserted anteriorly,
posteriorly, or transforaminal in between vertebral bodies of the
spine. The design provides an optimal surface coverage while acting
as a compliant interbody or disc. It is held in place by various
embodiments of deployable bone anchors. The I-shaped support member
204 of FIG. 2 allows additional rigidity and support through the
middle of the device and acts as a living-hinge in
flexion-extension. The I-shaped support member 204 may also be cut
in both the front and side planes to allow two degrees of freedom,
acting as a joint that can bend in both the sagital and transverse
planes.
[0042] The compliant material monolithic spinal fusion devices 100,
200, 300, 400, 500 are used in surgery to stabilize the human
spine. They aid in restoring the normal biomechanics of the
thoraco-lumbar spine. In conjunction with a dynamic rod/screw
system or stand-alone, the devices 100, 200, 300, 400, 500 reduce
the chances of adjacent disk disease. These devices 100, 200, 300,
400, 500 are an improvement over existing devices in terms of
fixation to the endplates. The devices 100, 200, 300, 400, 500 are
designed to work with any appropriate compliant implantable
material and may utilize all the standard surgical tools that
accompany such devices 100, 200, 300, 400, 500.
[0043] The foregoing description of the specific embodiments will
so fully reveal the general nature of the embodiments herein that
others can, by applying current knowledge, readily modify and/or
adapt for various applications such specific embodiments without
departing from the generic concept, and, therefore, such
adaptations and modifications should and are intended to be
comprehended within the meaning and range of equivalents of the
disclosed embodiments. It is to be understood that the phraseology
or terminology employed herein is for the purpose of description
and not of limitation. Therefore, while the embodiments herein have
been described in terms of preferred embodiments, those skilled in
the art will recognize that the embodiments herein can be practiced
with modification within the spirit and scope of the appended
claims.
* * * * *