U.S. patent application number 17/315694 was filed with the patent office on 2021-08-26 for expandable inter-body fusion devices and methods.
The applicant listed for this patent is SPECTRUM SPINE IP HOLDINGS, LLC. Invention is credited to John E. Pendleton, James C. Robinson.
Application Number | 20210259849 17/315694 |
Document ID | / |
Family ID | 1000005571979 |
Filed Date | 2021-08-26 |
United States Patent
Application |
20210259849 |
Kind Code |
A1 |
Robinson; James C. ; et
al. |
August 26, 2021 |
EXPANDABLE INTER-BODY FUSION DEVICES AND METHODS
Abstract
An expandable inter-body fusion device is presented. The
expandable inter-body fusion device can have a first plate, a
second plate, and an insert positioned substantially therebetween
the first plate and the second plate. The first plate, the second
plate, and the insert define an interior cavity. Moving the insert
longitudinally with respect to the first and second plates
increases or decreases the distance of the first plate with respect
to the second plate, effectively expanding the inter-body fusion
device and increasing the volume of the interior cavity.
Inventors: |
Robinson; James C.;
(Atlanta, GA) ; Pendleton; John E.; (Atlanta,
GA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
SPECTRUM SPINE IP HOLDINGS, LLC |
Atlanta |
GA |
US |
|
|
Family ID: |
1000005571979 |
Appl. No.: |
17/315694 |
Filed: |
May 10, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15978664 |
May 14, 2018 |
11051951 |
|
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17315694 |
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14216996 |
Mar 17, 2014 |
9987143 |
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15978664 |
|
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61786612 |
Mar 15, 2013 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2002/30904
20130101; A61F 2002/30579 20130101; A61F 2002/30556 20130101; A61F
2002/30507 20130101; A61F 2002/30266 20130101; A61F 2/4611
20130101; A61F 2002/30261 20130101; A61F 2002/30398 20130101; A61F
2/30744 20130101; A61F 2/4684 20130101; A61F 2/447 20130101; A61F
2002/30593 20130101 |
International
Class: |
A61F 2/44 20060101
A61F002/44; A61F 2/30 20060101 A61F002/30; A61F 2/46 20060101
A61F002/46 |
Claims
1. An expandable inter-body fusion device for use in surgery
comprising: a first plate having an upper bone contact surface, an
opposed first inner surface and at least one longitudinal sidewall;
a second plate underlying at least a portion of the first plate,
the second plate having a lower bone contact surface, an opposed
second inner surface and at least one longitudinal sidewall; and an
insert comprising a frame having opposed lateral sides from each of
which a respective longitudinal rail protrudes laterally, each
longitudinal rail extending longitudinally and comprising a
plurality of ramps, each ramp having at least one inclined surface
and at least one substantially flat surface that define contours of
the respective rail in a vertical direction, wherein the insert is
positionable in abutting relationship between the first and second
plates with their longitudinal sidewalls substantially aligned to
form a set of aligned sidewalls defining a plurality of voids
therebetween, wherein the expandable inter-body fusion device is
selectively adjustable between an unexpanded position, in which the
insert is in abutting relationship with the first and second plates
and the device has an interior cavity having a first cavity size,
and in which each of the plurality of ramps of the insert is
positioned substantially within a respective void of the plurality
of voids, and an expanded position, in which the insert is in
abutting relationship with the first and second plates and the
interior cavity has a second cavity size greater than the first
cavity size, and in which the at least one substantially flat
surface of each of the ramps of the insert abuts at least a portion
of the sidewalls of the first and second plates to maintain the
expandable inter-body fusion device in the expanded position, and
wherein the device is transitioned from the unexpanded position to
the expanded position by longitudinally sliding the insert with
respect to the first and second plates, thereby causing the at
least one inclined surface of each of the ramps to exit its
respective void and engage a portion of the sidewalls of the first
and second plates to drive them apart.
2. The device of claim 1, wherein the at least one void is sized
and shaped to complimentarily accept the ramp of the insert
therein.
3. The device of claim 1, wherein the first plate is at a
transverse angle relative to the second plate.
4. The device of claim 1, wherein the at least one ramp comprises
an upper inclined surface, a lower inclined surface, an upper flat
surface and a lower flat surface.
5. The device of claim 1, wherein the insert is movable about and
between a first insert position, in which the device is in the
first unexpanded position, and a second insert position, in which
the device is in the second expanded position.
6. The device of claim 5, wherein in the second insert position,
the at least one substantially flat surface supports at least a
portion of the longitudinal sidewall of at least one of the first
and second plates.
7. The device of claim 5, wherein upon movement about and between
the first insert position and the second insert position, the at
least one inclined surface cams a portion of the longitudinal
sidewall of at least one of the first and second plates.
8. The device of claim 5, wherein the device has a leading end and
a trailing end.
9. The device of claim 8, wherein the at least one inclined surface
of the at least one ramp is positioned between the leading end of
the device and the at least one flat surface of the at least one
ramp.
10. The device of claim 8, wherein the at least one inclined
surface of the at least one ramp is positioned between the trailing
end of the device and the at least one flat surface of the at least
one ramp.
11. The device of claim 1, further comprising an endcap configured
to engage a portion of at least one of the first plate, the second
plate and the insert to maintain the insert in a desired
position.
12. The device of claim 11, wherein portions of a trailing end of
the device are threaded to matingly engage complimentary threading
on the endcap.
13. The device of claim 11, wherein the endcap comprises a cam lock
having at least one lead configured to matingly engage a portion of
at least one of the first and second plates.
14. The device of claim 13, wherein an aperture in communication
with the interior cavity is defined in a trailing end of the
device.
15. The device of claim 14, wherein the endcap is rotatable about
and between a first orientation, in which the at least one lead can
be inserted through the aperture and into the interior cavity, and
a second orientation, in which at least a portion of the at least
one lead engages at least one of the first and second plates.
16. An expandable inter-body fusion device for use in surgery
comprising: a first plate having an upper bone contact surface, an
opposed first inner surface and at least one longitudinal sidewall;
a second plate underlying at least a portion of the first plate,
the second plate having a lower bone contact surface, an opposed
second inner surface and at least one longitudinal sidewall; and an
insert comprising a frame having opposed lateral sides from each of
which a respective longitudinal rail protrudes laterally, each
longitudinal rail comprising a plurality of ramps, each ramp having
at least one inclined surface and at least one substantially flat
surface that define contours in the vertical direction of the
respective rail, wherein the insert is positionable in abutting
relationship between the first and second plates with their
longitudinal sidewalls substantially aligned to form a set of
aligned sidewalls defining a plurality of voids therebetween,
wherein the expandable inter-body fusion device is selectively
adjustable between an unexpanded position, in which the device has
an interior cavity having a first cavity size and each of the
plurality of ramps of the insert is positioned substantially within
a respective void of the plurality of voids, and an expanded
position, in which the interior cavity has a second cavity size
greater than the first cavity size, and in which the at least one
substantially flat surface of each of the ramps of the insert abuts
at least a portion of the sidewalls of the first and second plates
to maintain the expandable inter-body fusion device in the expanded
position, and wherein the device is transitioned from the
unexpanded position to the expanded position by longitudinally
sliding the insert with respect to the first and second plates,
thereby causing the at least one inclined surface of each of the
ramps to exit the respective void and engage a portion of the
sidewalls of the first and second plates to drive them apart.
17. The device of claim 16, wherein at least one longitudinal
sidewall of at least one of the first and second plates defines one
of a groove, a recess, and a lip extending longitudinally along the
at least one of the first and second plates, and wherein the insert
defines a tongue extending in a longitudinal direction along the
insert, the tongue being complementary to and mating with the one
of the groove, recess and lip to allow expansion of the device.
18. The device of claim 16, wherein at least one longitudinal
sidewall of at least one of the first and second plates defines one
of a groove, a recess, and a lip extending longitudinally along the
at least one of the first and second plates, and wherein the insert
defines a tongue extending in a longitudinal direction along the
insert, the tongue being complementary to and mating with the one
of the groove, recess and lip when the device is in the expanded
position, to retain the first and second plates to the insert after
expansion of the device.
19. An expandable inter-body fusion device for use in surgery
comprising: a first plate having an upper bone contact surface, an
opposed first inner surface and at least one longitudinal sidewall
defining a lowermost sidewall surface contoured in a vertical
direction; a second plate underlying at least a portion of the
first plate, the second plate having a lower bone contact surface,
an opposed second inner surface and at least one longitudinal
sidewall defining an uppermost sidewall surface contoured in the
vertical direction; and an insert positioned substantially between
the first plate and the second plate, wherein the insert comprises
a frame with a plurality of opposed longitudinal frame sides,
wherein a longitudinal rail protrudes laterally from a lateral
surface of each of the longitudinal frame sides to define upper and
lower rail surfaces contoured in the vertical direction on opposing
sides of each longitudinal rail and between the lowermost and
uppermost sidewall surfaces, and wherein each longitudinal rail
comprises a plurality of ramps, each ramp having at least one
inclined surface and at least one substantially flat surface that
define contours in the vertical direction of the upper and lower
rail surfaces, wherein each longitudinal sidewall of the first
plate substantially aligns with a respective longitudinal sidewall
of the second plate to form a set of aligned sidewall surfaces
defining a plurality of voids between the lowermost and uppermost
sidewall surfaces, wherein the expandable inter-body fusion device
is selectively adjustable between an unexpanded position, in which
the device has an interior cavity having a first cavity size and
each of the plurality of ramps of the insert is positioned
substantially within a respective void of the plurality of voids of
between the aligned sidewall surfaces, and an expanded position, in
which the interior cavity has a second cavity size greater than the
first cavity size, and in which the at least one substantially flat
surface of each of the ramps of the insert abuts at least a portion
of the sidewall surfaces of the first and second plates to maintain
the expandable inter-body fusion device in the expanded position,
and wherein the device is transitioned from the unexpanded position
to the expanded position by longitudinally sliding the insert with
respect to the first and second plates, thereby causing the at
least one inclined surface of each of the ramps to engage with a
portion of the sidewall surfaces first and second plates and drive
them away from each other in the vertical direction.
20. The device of claim 16, wherein at least one longitudinal
sidewall of at least one of the first and second plates defines one
of a groove, a recess, and a lip extending longitudinally along the
at least one of the first and second plates, and wherein the insert
defines a tongue extending in a longitudinal direction along the
insert, the tongue being complementary to and mating with the one
of the groove, recess and lip when the device is in the expanded
position, to retain the first and second plates to the insert after
expansion of the device.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of co-pending U.S.
application Ser. No. 15/978,664, filed May 14, 2018, which is a
continuation of U.S. application Ser. No. 14/216,996, filed Mar.
17, 2014 now U.S. Pat. No. 9,987,143 issued on Jun. 5, 2018, which
claims the benefit of priority of U.S. Provisional Application No.
61/786,612, filed Mar. 15, 2013, which is incorporated in its
entirety by this reference.
FIELD OF THE INVENTION
[0002] This invention relates generally to spinal surgery, and more
particularly to devices and methods for stabilization of the spine
in association with placement of an expandable inter-body construct
for inter-body fusion or the like.
BACKGROUND OF THE INVENTION
[0003] Damage or disease that affects the spinal disc within an
individual's spinal column may lead to neurologic impairment with
possible permanent damage to the surrounding tissue. Maintaining
proper anatomic spacing and lordosis within the spine is critical
to ensuring continued functionality of the surrounding tissue and
for the spinal column, the spinal cord and nerve roots and
therefore, avoidance of long term serious neurological
impairment.
[0004] Typically, spinal implants that are used as a spacer type of
device have a fixed overall length and are implanted without the
ability to adjust the degree of expansion or curvature without
using multiple insertion instrumentation. Some of the known
procedures for introducing spinal implants comprise Anterior Lumbar
Inter-body Fusion ("ALIF"), Lateral Lumbar Inter-body Fusion
("LLIF"), Posterior Lumbar Inter-body Fusion ("PLIF"), Oblique
Lumbar Inter-body Fusion ("OLIF"), Direct Lateral Fusion ("DLIF"),
Transforaminal Lumbar Interbody Fusion ("TLIF"), and the like. A
need remains for a multipurpose instrument to be used to implant a
spacer type of implant that allows the surgeon to minimize the size
of the surgical incision, facilitate the operative technique and
decrease patient morbidity.
SUMMARY
[0005] Presented herein is an expandable inter-body fusion device,
or implant, for use in spinal surgery. In one aspect, the
expandable inter-body fusion device comprises a first plate, a
second plate, and an insert positioned substantially therebetween
the first plate and the second plate. The first plate, the second
plate, and the insert define an interior cavity. In one aspect,
moving the insert longitudinally with respect to the first and
second plates increases or decreases the distance between the first
plate relative to the second plate, effectively expanding the
inter-body fusion device and increasing the volume of the interior
cavity.
[0006] It is contemplated that this technology can be used for a
variety of implants used for a variety of spinal procedures. These
procedures include, but are not limited to OLIF (anterior or
posterior), DLIF, PLIF, TLIF, ALIF, and LLIF. So, depending upon
the procedure and point of insertion for the implant, the geometry
of the implant can differ.
[0007] In an exemplified aspect, at least one of the first plate
and the second plate define at least one graft window that is in
communication with the interior cavity.
[0008] Also presented herein is a method of using an expandable
inter-body fusion device during an inter-body fusion procedure. In
one aspect, the method comprises accessing the desired disc space,
choosing the correct insert size with the appropriate height and
angle, inserting the expandable inter-body fusion device into the
desired area in the disc space, expanding the expandable inter-body
fusion device from the first non-expanded position to the second
expanded position, and securing the insert to the first and second
plates. An additional step of packing the interior cavity via the
aperture in the trailing end of the expandable inter-body fusion
device with bone fusion material either prior to or after expansion
is also contemplated.
[0009] Related methods of operation are also provided. Other
apparatuses, methods, systems, features, and advantages of the
expandable inter-body fusion device and the method of its use will
be or become apparent to one with skill in the art upon examination
of the following figures and detailed description. It is intended
that all such additional apparatuses, methods, systems, features,
and advantages be included within this description, be within the
scope of the expandable inter-body fusion device and the method of
its use, and be protected by the accompanying claims.
DESCRIPTION OF THE FIGURES
[0010] The accompanying drawings, which are incorporated in and
constitute a part of this specification, illustrate certain aspects
of the instant invention and together with the description, serve
to explain, without limitation, the principles of the invention.
Like reference characters used therein indicate like parts
throughout the several drawings.
[0011] FIG. 1 is a perspective view of one aspect of an expandable
inter-body fusion device that is expandable by moving an insert
toward a leading end of the device, in a first unexpanded
position;
[0012] FIG. 2 is a side elevational view of the expandable
inter-body fusion device of FIG. 1, illustrating an aspect that is
not substantially angled longitudinally, in the first unexpanded
position;
[0013] FIG. 3 is a trailing end elevational view of the expandable
inter-body fusion device FIG. 1, illustrating an aspect that is
angled transversely;
[0014] FIG. 4 is a perspective view of the insert of the expandable
inter-body fusion device of FIG. 1;
[0015] FIG. 5 is a side elevational view of the insert of FIG.
4;
[0016] FIG. 6 is a bottom perspective view of a first plate of the
expandable inter-body fusion device of FIG. 1;
[0017] FIG. 7 is a perspective view of the expandable inter-body
fusion device of FIG. 1 in a second expanded position;
[0018] FIG. 8 is a side elevational view of the expandable
inter-body fusion device of FIG. 1 in the second expanded
position;
[0019] FIG. 9 is a perspective view of a threaded endcap for use
with the expandable inter-body fusion device of FIG. 1;
[0020] FIG. 10 is a cutaway perspective view of the expandable
inter-body fusion device of FIG. 1 in the second expanded position,
cut substantially along the longitudinal axis and having the endcap
of FIG. 9;
[0021] FIG. 11 is perspective view of an endcap having a single
lead cam lock;
[0022] FIG. 12 is a cutaway perspective view of an expandable
inter-body fusion device in the second expanded position and having
the endcap of FIG. 11;
[0023] FIG. 13 is a perspective view of the expandable inter-body
fusion device of FIG. 12;
[0024] FIG. 14 is a perspective view of an endcap coupled to a
boss;
[0025] FIG. 15 is a perspective view of the boss of FIG. 14;
[0026] FIG. 16 is a perspective view of the endcap of FIG. 14;
[0027] FIG. 17 is a cutaway perspective view of an expandable
inter-body fusion device in the second expanded position having an
endcap and boss as in FIG. 14;
[0028] FIGS. 18A-18I are a series of perspective views of an
expandable inter-body fusion device used in a DLIF approach;
[0029] FIG. 19 is a perspective view of one aspect of an expandable
inter-body fusion device that is expanded by moving an insert
toward the leading end of the device, in the first unexpanded
position;
[0030] FIG. 20 is a side elevational view of the expandable
inter-body fusion device of FIG. 19, illustrating an aspect that is
angled longitudinally, in the first unexpanded position;
[0031] FIG. 21 is a side elevational view of the expandable
inter-body fusion device of FIG. 19, illustrating the longitudinal
angle;
[0032] FIG. 22 is a side elevational view of the expandable
inter-body fusion device FIG. 19, illustrating an aspect that is
angled transversely;
[0033] FIG. 23 is a trailing end elevational view of the expandable
inter-body fusion device FIG. 19, illustrating the transverse
angle;
[0034] FIG. 24 is a side elevational view of the expandable
inter-body fusion device of FIG. 19 in the second expanded
position;
[0035] FIGS. 25A-25I are a series of perspective views of an
expandable inter-body fusion device used in an anterior OLIF
approach;
[0036] FIG. 26 is a perspective view of one aspect of an expandable
inter-body fusion device that is expanded by moving an insert
toward the trailing end of the device, in the first unexpanded
position;
[0037] FIG. 27 is a side elevational view of the expandable
inter-body fusion device of FIG. 26;
[0038] FIG. 28 is a trailing end elevational view of the expandable
inter-body fusion device FIG. 26;
[0039] FIG. 29 is a perspective view of the insert of the
expandable inter-body fusion device of FIG. 26;
[0040] FIG. 30 is a perspective view of the expandable inter-body
fusion device of FIG. 26 in the second expanded position; and
[0041] FIGS. 31A-31I are a series of perspective views of an
expandable inter-body fusion device used in a posterior OLIF
approach.
DESCRIPTION OF THE INVENTION
[0042] The present invention can be understood more readily by
reference to the following detailed description, examples, and
claims, and their previous and following description. Before the
present system, devices, and/or methods are disclosed and
described, it is to be understood that this invention is not
limited to the specific systems, devices, and/or methods disclosed
unless otherwise specified, as such can, of course, vary. It is
also to be understood that the terminology used herein is for the
purpose of describing particular aspects only and is not intended
to be limiting.
[0043] The following description of the invention is provided as an
enabling teaching of the invention in its best, currently known
aspect. Those skilled in the relevant art will recognize that many
changes can be made to the aspects described, while still obtaining
the beneficial results of the present invention. It will also be
apparent that some of the desired benefits of the present invention
can be obtained by selecting some of the features of the present
invention without utilizing other features. Accordingly, those who
work in the art will recognize that many modifications and
adaptations to the present invention are possible and can even be
desirable in certain circumstances and are a part of the present
invention. Thus, the following description is provided as
illustrative of the principles of the present invention and not in
limitation thereof.
[0044] As used herein, the singular forms "a," "an" and "the"
include plural referents unless the context clearly dictates
otherwise. Thus, for example, reference to a "plate" includes
aspects having two or more plates unless the context clearly
indicates otherwise.
[0045] Ranges can be expressed herein as from "about" one
particular value, and/or to "about" another particular value. When
such a range is expressed, another aspect includes from the one
particular value and/or to the other particular value. Similarly,
when values are expressed as approximations, by use of the
antecedent "about," it will be understood that the particular value
forms another aspect. It will be further understood that the
endpoints of each of the ranges are significant both in relation to
the other endpoint, and independently of the other endpoint.
[0046] As used herein, the terms "optional" or "optionally" mean
that the subsequently described event or circumstance may or may
not occur, and that the description includes instances where said
event or circumstance occurs and instances where it does not.
[0047] Terms used herein, such as "exemplary" or "exemplified," are
not meant to show preference, but rather to explain that the aspect
discussed thereafter is merely one example of the aspect
presented.
[0048] Additionally, as used herein, relative terms, such as
"substantially", "generally", "approximately", and the like, are
utilized herein to represent an inherent degree of uncertainty that
may be attributed to any quantitative comparison, value,
measurement, or other representation. These terms are also utilized
herein to represent the degree by which a quantitative
representation may vary from a stated reference without resulting
in a change in the basic function of the subject matter at
issue.
[0049] In one aspect, presented herein is an expandable inter-body
fusion device 10 for use in spinal surgery, such as, but not
limited to, ALIF, OLIF, TLIF, LLIF, PLIF, and DLIF procedures.
[0050] In one aspect and as illustrated in FIGS. 1-3, the
expandable inter-body fusion device 10 comprises a first plate 100,
a second plate 200, and an insert 300 positioned substantially
therebetween the first plate 100 and the second plate 200. The
first plate has a leading edge 102, a trailing edge 104, an upper
bone contact surface 110 and an opposed first plate inner surface
120. The second plate 200 has a leading edge 202, a trailing edge
204, a lower bone contact surface 210 and an opposed second plate
inner surface 220. The first plate 100, the second plate 200, and
the insert 300 define an interior cavity 15. The expandable
inter-body fusion device 10 has a leading end 17 and a trailing end
19. In one aspect, moving the insert longitudinally with respect to
the first and second plates (that is, either toward the leading end
or toward the trailing end of the device) can increase the distance
between the first plate 100 relative to the second plate 200,
effectively expanding the inter-body fusion device and increasing
the volume of the interior cavity 15.
[0051] At least one of the first plate 100 and the second plate 200
has at least one longitudinal sidewall 130, 230 extending
substantially from the respective inner surface 120, 220. In one
aspect, the at least one longitudinal sidewall 130, 230 comprises a
plurality of longitudinal sidewalls. For example, the longitudinal
sidewall can comprise two longitudinal sidewalls. In another
aspect, the longitudinal sidewall(s) can be positioned
substantially near a peripheral edge 140, 240 of the first and/or
second plate. The longitudinal sidewall 130 of the first plate 100
defines a lowermost sidewall surface 130a contoured in a vertical
direction, as best shown in FIG. 6. The longitudinal sidewall 230
of the second plate 200 defines an uppermost sidewall surface 230a
contoured in a vertical direction, as best shown in FIG. 7.
[0052] Referring now to FIGS. 4 and 5, in one exemplified aspect,
the insert 300 comprises a frame 310 with a plurality of
longitudinal frame sides 320. In one aspect, a longitudinal rail
330 protrudes from the external surface of each of the longitudinal
frame sides 320. In another aspect, each longitudinal rail
comprises at least one ramp 340 having at least one inclined
surface 342 and at least one substantially flat surface 344. As
illustrated in FIG. 5, in a further aspect, each ramp can comprise
an upper inclined surface 343, a lower inclined surface 345, an
upper flat surface 347 and a lower flat surface 349. In this aspect
the longitudinal rail 330 has a first rail thickness that
corresponds to the distance between the upper flat surface and the
lower flat surface of the ramp 340, and a second rail thickness in
areas of the longitudinal rail that do not comprise the ramp. As
can be appreciated, the second rail thickness can be less than the
first rail thickness. In yet another aspect, each of the
longitudinal rails 330 comprises a plurality of ramps. For example,
each longitudinal rail can comprise a first ramp 340 spaced from a
second ramp by a predetermined longitudinal distance along the
longitudinal rail.
[0053] Correspondingly, in one aspect, each longitudinal sidewall
130 of the first plate 100 can substantially align with a
longitudinal sidewall 230 of the second plate 200. For example,
each longitudinal sidewall of the first plate can substantially
overlie at least a portion of a longitudinal sidewall of the second
plate. Each set of substantially aligned longitudinal sidewalls (a
longitudinal sidewall 130 from the first plate 100 and a
longitudinal sidewall 230 from the second plate 200) define at
least one void 150, as illustrated in FIGS. 1 and 2. In another
aspect, the at least one void can be sized and shaped to
complimentarily accept a ramp 340 of the insert 300 therein. In
this aspect, in a first unexpanded position (as illustrated in FIG.
2), each of the ramps of the insert can be positioned substantially
within the void 150 formed between the substantially aligned
longitudinal sidewalls 130, 230 of the first and second plates 100,
200. In the first unexpanded position, each longitudinal sidewall
130, 230 can be positioned substantially near or in contact with
the respective longitudinal rail 330 of the insert 300. The first
unexpanded position is the position in which the expandable
inter-body fusion device 10 can be to be inserted between the
adjacent vertebrae of a patient.
[0054] The expandable inter-body fusion device 10 can be
selectively adjusted about and between the first unexpanded
position, in which the ramps 340 of the insert 300 can be
positioned substantially within the void 150 of the first and
second plates 100, 200, and a second expanded position in which the
ramps of the insert are not positioned substantially within the
void. In one aspect, in the second expanded position, the flat
surface 344 of the ramp can engage the inner surface 120 of the
longitudinal sidewall 130 of the first plate 100 and/or the inner
surface 220 of the longitudinal sidewall 230 of the second plate
200. As can be appreciated, in the second expanded position, the
expandable inter-body fusion device 10 can have a height and
interior cavity 15 volume that is greater than the height and
interior cavity volume of the expandable inter-body fusion device
in the first, unexpanded position. That is, in the first unexpanded
position, the interior cavity 15 of the device can have a first
cavity size, and in the second expanded position the interior
cavity has a second cavity size that is greater than the first
cavity size.
[0055] To expand the expandable inter-body fusion device 10 into
the second expanded position, the insert 300 can be moved
longitudinally from a first insert position, in which the ramps 340
of the insert 300 can be positioned substantially within the void
150 of the first and second plates 100, 200, toward either the
trailing end 19 or the leading end 17 of the device to a second
insert position, thereby moving the ramps 340 into contact with a
portion of at least one of the longitudinal sidewalls 130, 230. In
this position, the aligned longitudinal sidewalls of the first and
second plates 100, 200 are separate by traveling up the inclined
surfaces 342 of the ramp until the first plate and the second plate
are separated and supported by the flat surfaces 344 of the ramp.
In the second expanded position, portions of the longitudinal
sidewalls are supported by the load bearing properties of the flat
surfaces of the ramps. As one skilled in the art can appreciate,
the amount of separation achievable between the first plate and the
second plate can be determined by the height of the ramp.
[0056] As shown in the figures, the ramps 340 can be double
inclined, with two inclined surfaces 342 (upper inclined surface
343 and lower inclined surface 345) and two flat surfaces 344
(upper flat surface 347 and lower flat surface 349). In this
aspect, each inclined surface can be configured to cam the
longitudinal sidewall 130, 230 of one of the first plate 100 or the
second plate 200 and each flat surface 344 configured to support a
portion of the respective longitudinal sidewall. However, it is
contemplated that the ramps can be single inclined, with only one
inclined surface and one flat per ramp. In this aspect, the
opposing surface would remain substantially adjacent and parallel
to the respective longitudinal sidewall.
[0057] In one aspect, the inclined surface 342 leads the ramp 340,
as shown in FIGS. 1 and 2. That is, the inclined surface of each
ramp is positioned between the leading end 17 of the expandable
inter-body fusion device 10 and the flat surface 344 of each ramp
340. As such, moving the insert 300 longitudinally toward the
leading end 17 of the device moves the device 10 from the first
unexpanded position, to the second expanded position. Optionally,
however, in another aspect, the inclined surface can trail the
ramp, as shown in FIG. 26. That is, in this aspect, the inclined
surface 342 of each ramp 340 can be positioned between the trailing
end 19 of the expandable inter-body fusion device and the flat
surface 344 of each ramp. Accordingly then, moving the insert 300
longitudinally toward the trailing end 19 of the expandable
inter-body fusion device 10 can move the device into the second
expanded position.
[0058] With reference to FIG. 5, in an exemplified aspect, the
insert 300 can have a first longitudinal tongue 350 extending from
the external surface of each of the longitudinal frame sides 320
and a second longitudinal tongue 355 extending from the external
surface of each of the longitudinal frame sides 320. In another
aspect, the first longitudinal tongue can be spaced from the second
longitudinal tongue a predetermined distance. In yet another
aspect, the first longitudinal tongue 350 can be positioned near or
adjacent to an upper edge of the longitudinal frame sides, and the
second longitudinal tongue 355 can be positioned near or adjacent
to a lower edge of the longitudinal frame sides 320. In a further
aspect, the first longitudinal tongue can be substantially parallel
to the second longitudinal tongue. Optionally, however, the first
the first longitudinal tongue 350 can be at an angle relative to
the second longitudinal tongue 355.
[0059] Correspondingly, in one aspect, the first plate 100 can
define a groove, recess, or lip 160 in each longitudinal sidewall
(as illustrated in FIG. 6) that is configured to mate with the
first longitudinal tongue 350 of the insert 300. In another aspect,
the second plate 200 can define a groove, recess, or lip 260
configured to mate with the second longitudinal tongue 355 of the
insert. The first longitudinal tongue and the second longitudinal
tongue can be configured to move within the groove or recess to
allow expansion of the device. In another aspect, at least one of
the groove, recess, and lip 160, 260 of the first and second plates
1000, 200 can engage the first longitudinal tongue 350 or the
second longitudinal tongue 355 to retain the first and second
plates to the insert 300 after expansion. Of course, it is
contemplated that the groove and tongue relationship can be
reversed.
[0060] It is contemplated that this technology can be used for a
variety of implants used for a variety of spinal procedures. As
mentioned before, these procedures include, but are not limited to
OLIF, DLIF, PLIF, ALIF, TLIF, and LLIF. Because of this, depending
upon the procedure and point of insertion for the implant, the
geometry of the implant can differ. For example, in a DLIF
expandable device, the approach is lateral. As such, the upper bone
contact surface 110 can be transversely angled with respect to the
lower bone contact surface 210 from a first sidewall to a second
sidewall to match, increase, or decrease lordosis, as shown in
FIGS. 3 and 23. Note, however, that the expandable inter-body
fusion device 10 is not necessarily angled longitudinally from the
leading end 17 of the device to the trailing end 19 of the 10. The
degree of transverse angle a can vary from about 0 degrees to about
15 degrees. In another aspect, the transverse angle a can vary from
about 4 degrees to about 12 degrees. In yet another aspect, the
transverse angle a can vary from about 6 degrees to about 8
degrees. The expandable inter-body fusion device 10 can expand in
height a distance from about 1 mm to about 5 mm, depending on the
original height of the device, the size of the void 150 of the
first and second plates 100, 200 and/or the height of the ramps 340
of the insert 300. In this example, the insert 300 can expand the
device symmetrically.
[0061] In an OLIF procedure, the expandable inter-body fusion
device 10 can be inserted obliquely, either anteriorly or
posteriorly. As such, similar to the DLIF implant, the upper bone
contact surface 110 can be angled transversely with respect to the
lower bone contact surface 210 from the first sidewall to the
second sidewall depending on the need to match, increase, or
decrease lordosis. In addition, the upper bone contact surface can
also be angled longitudinally with respect to the lower bone
contact surface from the leading end 17 of the device to the
trailing end 19, as illustrated in FIG. 21. In one aspect, a
longitudinal angle .beta. between the upper bone contact surface
110 and the lower bone contact surface can vary from about O
degrees to about 15 degrees. In another aspect, the longitudinal
angle .beta. can vary from about 4 degrees to about 12 degrees. In
yet another aspect, the longitudinal angle .beta. can vary from
about 6 degrees to about 8 degrees. The combination of longitudinal
angle .beta. and transverse angle a can vary depending about the
angle of insertion. It would be desired to at least substantially
fit the expandable inter-body fusion device 10 with the particular
insertion approach angle so that the resulting combined angle is
substantially posterior-anterior only or not at all. Thus, while
the upper bone contact surface 110 can be angled with respect to
the lower bone contact surface 210 in two planes, the device
substantially ensures orthogonal lordosis.
[0062] In an exemplified aspect, at least one of the first plate
100 and the second plate 200 can define at least one graft window
170, 270 that is in communication with the interior cavity 15. The
at least one graft window 170 defined in the first plate can
overlie at least a portion of the at least one graft window 270 of
the second plate, thereby permitting bone growth therethrough. In
another aspect, the upper bone contact surface 110 of the first
plate 100 comprises ridges 112 for frictionally engaging a first
vertebra of the patient. As can be appreciated, the lower bone
contact surface 210 of the second plate can comprise ridges 212 to
frictionally engage a second vertebra of the patient.
[0063] In one aspect, the leading end 17 of the expandable
inter-body fusion device 10 can be tapered to facilitate insertion.
For example, a leading portion of the first plate 100, the second
plate 200, and/or the insert 300 can be tapered to facilitate
insertion. In another aspect and as illustrated in FIGS. 3 and 4,
the trailing end 19 of the insert can define an aperture 360 in
communication with the interior cavity 15. The aperture 360 can
facilitate the passage of bone growth material, such as for example
and not meant to be limiting, autograft or allograft bone product,
or synthetic bone substitute, and the like. In this fashion, the
interior cavity 15 can be packed with bone growth material after
the expandable inter-body fusion device 10 has been expanded to the
second expanded position.
[0064] In one aspect, the device can also comprise an endcap 370
configured to engage the insert, as illustrated in FIG. 7. For
example, where the expandable inter-body fusion device 10 is
expanded to the second expanded position by pulling the insert 300
from the leading end 17 toward the trailing end 19, the endcap can
be used to maintain the device in the second expanded position. In
another aspect, the endcap can be sized and shaped so that a
portion of the endcap 370, such as a flange and the like, can
extend past the peripheral edge of the aperture 360 of the insert
300. In this aspect, when the endcap is engaged with the insert,
the endcap 370 can prevent the insert 300 from moving back toward
the leading end of the device. As one skilled in the art can
appreciate, movement of the insert back toward the leading end 17
could result in the undesired movement of the inter-body fusion
device from the second expanded position toward the first
unexpanded position. In a further aspect, portions of the trailing
end of the device, such as portions of the first plate 100, the
second plate 200 and/or the insert 300 can be threaded to
facilitate the complimentary threading of the endcap. Additionally,
the threaded trailing end of the device 10 can also be used to
engage the distal end of the insertion tool (not shown) and permit
the movement of the insert with respect to the first and second
plates. In yet another aspect, a leading end of the insert can
comprise a tapered nose 390, as shown in FIG. 27.
[0065] In another aspect, where the expandable inter-body fusion
device 10 is expanded to the second expanded position by pushing
the insert 300 from the trailing end 19 toward the leading end 17,
the device can further comprise a structure to facilitate securing
the insert to a portion of the first plate 100 and/or the second
plate 200, or to an adjacent vertebra of the patient. For example,
in one aspect and as illustrated in FIG. 11, the endcap 370
comprises a lock 376 configured to matingly engage a portion of the
first and second plates 100, 200. In one aspect, the lock comprises
at least one lead 375. In another aspect, the lock can be a single
or dual lead cam lock. The leads can be tapered or square ended. In
this aspect, the endcap can be inserted through the aperture 360
defined in the trailing end 19 of the device and into the interior
cavity 15 with the leads rotated to a first orientation in which
the leads 375 do not engage the device (as illustrated in FIG. 13).
Upon entering the cavity, the endcap can be rotated to a second
orientation in which the leads engage a portion of at least one of
the first and second plates 100, 200.
[0066] In another aspect and as illustrated in FIGS. 15-17, the
endcap can further comprise a boss 378 having a lock 376. In one
aspect, the lock comprises at least one lead 375. In another
aspect, the lock can be a single or dual lead cam lock. In this
aspect, the boss can define internal threads that are
complimentarily sized to engage external threads positioned on a
portion of the endcap 370. In use, then, the lock 376 of the boss
can be configured to engage a portion of the first and second
plates 100, 200, and the end cap can engage the boss. In still
another aspect, either the endcap itself or a separate boss can
comprise radially extending blades (not shown) that, when rotated,
are configured to engage the adjacent bony structure to retain the
expandable inter-body device in the desired position. It is also
contemplated that the inner surface 120, 220 of the first and
second plates can have a threaded portion to engage an endcap 370
having external threads.
[0067] In one aspect, as shown in FIG. 28, the expandable
inter-body fusion device 10 can be longitudinally cannulated. This
aspect enables the device to be inserted over a guide wire. As one
skilled in the art can appreciate, in an exemplified aspect, the
insertion tool would necessarily have to be cannulated.
[0068] Also presented herein is a method of using an expandable
inter-body fusion device 10 during an inter-body fusion procedure.
In one aspect, the method comprises accessing the desired disc
space, choosing the correct expandable inter-body fusion device
size with the appropriate height and angle, inserting the
expandable inter-body fusion device 10 into the desired area in the
disc space, expanding the expandable inter-body fusion device from
the first unexpanded position to the second expanded position with
longitudinal movement of the insert 300, and securing the insert to
the first and second plates 100, 200. An additional step of packing
the interior cavity 15 via the aperture 360 in the trailing end 19
of the expandable inter-body fusion device with bone fusion
material either prior to or after expansion is also contemplated.
In one aspect, the step of securing the insert to the first and
second plates can be replaced by securing the expandable inter-body
fusion device 10 to the surrounding bony structure. In another
aspect, the step of expanding the inter-body fusion device
comprises the step of moving the insert 300 with respect to the
first and second plates 100, 200 toward the trailing end 19 of the
expandable inter-body fusion device. In still another aspect, the
step of expanding the expandable inter-body fusion device 10
comprises the step of moving the insert with respect to the first
and second plates toward the leading end 17 of the expandable
inter-body fusion device.
[0069] In one aspect, the step of choosing the correct expandable
inter-body fusion device 10 size with the appropriate height and
angle comprises placing an undersized trial device in the disc
space, expanding the trial device to the second expanded position,
and repeating until the correct height and lordosis is found. The
trial height and angle gives the information to prescribe the
correct expandable inter-body fusion device for the procedure.
[0070] Although several aspects of the invention have been
disclosed in the foregoing specification, it is understood by those
skilled in the art that many modifications and other aspects of the
invention will come to mind to which the invention pertains, having
the benefit of the teaching presented in the foregoing description
and associated drawings. It is thus understood that the invention
is not limited to the specific aspects disclosed hereinabove, and
that many modifications and other aspects are intended to be
included within the scope of the appended claims. Moreover,
although specific terms are employed herein, as well as in the
claims that follow, they are used only in a generic and descriptive
sense, and not for the purposes of limiting the described
invention.
* * * * *