U.S. patent application number 11/031362 was filed with the patent office on 2005-08-25 for vertebral body replacement apparatus and method.
Invention is credited to Kozak, Jeffrey A., Larosa, Francesco, Lorenz, Mark A., Wolek, Howard, Zindrick, Michael R..
Application Number | 20050187625 11/031362 |
Document ID | / |
Family ID | 34549218 |
Filed Date | 2005-08-25 |
United States Patent
Application |
20050187625 |
Kind Code |
A1 |
Wolek, Howard ; et
al. |
August 25, 2005 |
Vertebral body replacement apparatus and method
Abstract
Various embodiments of the present invention relate to an
apparatus for vertebral body replacement and methods associated
therewith. In one embodiment, a vertebral body replacement
apparatus may be used to correct and stabilize the spine (e.g., the
thoracolumbar spine (T1-L5)). In another embodiment, a vertebral
body (e.g., a diseased and/or damaged vertebral body) that has been
resected or excised (e.g., for the treatment of a tumor or trauma)
may be replaced (with the height of the resected or excised
vertebral body being substantially replaced and restored by the
apparatus of the present invention).
Inventors: |
Wolek, Howard; (Morris
Plains, NJ) ; Larosa, Francesco; (Neptune, NJ)
; Kozak, Jeffrey A.; (Houston, TX) ; Lorenz, Mark
A.; (Hinsdale, IL) ; Zindrick, Michael R.;
(Hinsdale, IL) |
Correspondence
Address: |
GREENBERG TRAURIG LLP
MET LIFE BUILDING
200 PARK AVENUE; 14TH FLOOR
NEW YORK
NY
10166
US
|
Family ID: |
34549218 |
Appl. No.: |
11/031362 |
Filed: |
January 7, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11031362 |
Jan 7, 2005 |
|
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10968586 |
Oct 19, 2004 |
|
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60512716 |
Oct 20, 2003 |
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Current U.S.
Class: |
623/17.11 |
Current CPC
Class: |
A61F 2002/30428
20130101; A61F 2002/30593 20130101; A61F 2002/30841 20130101; A61F
2250/0063 20130101; A61F 2250/0098 20130101; A61F 2002/30706
20130101; A61F 2002/30616 20130101; A61F 2220/0041 20130101; A61F
2002/3008 20130101; A61F 2002/30433 20130101; A61F 2002/3082
20130101; A61F 2220/0025 20130101; A61F 2/44 20130101; A61F
2002/448 20130101; A61F 2002/30331 20130101; A61F 2002/305
20130101; A61F 2002/30772 20130101; A61F 2002/30904 20130101; A61F
2/4611 20130101; A61F 2/30744 20130101; A61F 2/4455 20130101; A61F
2002/30604 20130101; A61F 2250/0082 20130101; A61F 2220/0033
20130101; A61F 2002/2835 20130101; A61F 2002/30599 20130101 |
Class at
Publication: |
623/017.11 |
International
Class: |
A61F 002/44 |
Claims
What is claimed is:
1. A vertebral body replacement apparatus for placement between a
first vertebra and a second vertebra, comprising: a first endplate
including a generally outward facing surface for contacting at
least a portion of a lower face of the first vertebra and a
generally inward facing surface including thereon at least two
pockets and at least two protrusions, wherein at least one
protrusion is disposed within each of the pockets; a second
endplate including a generally outward facing surface for
contacting at least a portion of an upper face of the second
vertebra and a generally inward facing surface including thereon at
least two pockets and at least two protrusions, wherein at least
one protrusion is disposed within each of the pockets; a first
lateral spacer including at least one aperture; and a second
lateral spacer including at least one aperture; wherein, when the
first and second lateral spacers are disposed between the first and
second endplates such that the first endplate is above the first
and second lateral spacers and the second endplate is below the
first and second lateral spacers, a first pair of opposed pockets
of the first and second endplates are configured to receive therein
at least a part of the first lateral spacer and a second pair of
opposed pockets of the first and second endplates are configured to
receive therein at least a part of the second lateral spacer; and
wherein the aperture of the first lateral spacer is configured to
receive at least one of the protrusions of each of the first and
second endplates when the first lateral spacer is received within
the first pair of pockets and the aperture of the second lateral
spacer is configured to receive at least one of the protrusions of
each of the first and second endplates when the second lateral
spacer is received within the second pair of pockets.
2. The apparatus of claim 1, wherein at least one of: (a) the
mating of each of the protrusions with a respective one of the
apertures provides lateral alignment between each of the first
endplate, the second endplate, the first lateral spacer and the
second lateral spacer; and (b) the mating of each of the lateral
spacers with a respective pocket provides lateral alignment between
each of the first endplate, the second endplate, the first lateral
spacer and the second lateral spacer.
3. The apparatus of claim 2, wherein at least one of the
protrusions and at least one of a respective one of the apertures
includes a locking mechanism for locking the protrusion in the
aperture.
4. The apparatus of claim 3, wherein the locking mechanism of the
protrusion and the locking mechanism of the aperture are configured
to permit unlocking thereof.
5. The apparatus of claim 4, wherein the locking mechanism of the
protrusion comprises a raised ridge and the locking mechanism of
the aperture comprises an indentation.
6. The apparatus of claim 4, wherein the locking mechanism of the
protrusion comprises a tab and the locking mechanism of the
aperture comprises a slot.
7. The apparatus of claim 1, wherein the aperture of the first
lateral spacer extends through the first lateral spacer and the
aperture of the second lateral spacer extends through the second
lateral spacer.
8. The apparatus of claim 1, wherein each of the first and second
lateral spacers includes a respective upper aperture adjacent the
generally inward facing surface of the first endplate for receiving
at least one of the protrusions of the first endplate and each of
the first and second lateral spacers includes a respective lower
aperture adjacent the generally inward facing surface of the second
endplate for receiving at least one of the protrusions of the
second endplate.
9. The apparatus of claim 1, wherein each of the first and second
lateral spacers has a lordotic angle between about 0-8 degrees.
10. The apparatus of claim 1, wherein the generally outward facing
surface of the first endplate is textured and the generally outward
facing surface of the second endplate is textured.
11. The apparatus of claim 10, wherein the texture is configured to
resist expulsion of the apparatus from between the first and second
vertebrae.
12. The apparatus of claim 10, wherein the texture is configured to
aid in insertion of the apparatus between the first and second
vertebrae.
13. The apparatus of claim 10, wherein the texture is configured to
aid in permitting bony ingrowth from the first and second
vertebrae.
14. The apparatus of claim 10, wherein the texture is selected from
the group including: (a) teeth; (b) grooves; and (c) ridges.
15. The apparatus of claim 1, wherein the first endplate, the
second endplate, the first lateral spacer and the second lateral
spacer are configured to define at least one hollow area when the
first and second lateral spacers are disposed between the first and
second endplates such that the first endplate is above the first
and second lateral spacers and the second endplate is below the
first and second lateral spacers.
16. The apparatus of claim 15, wherein the hollow area is
configured to aid in permitting bony ingrowth from the first and
second vertebrae.
17. The apparatus of claim 1, wherein at least one of the first
endplate, the second endplate, the first lateral spacer and the
second lateral spacer comprises polyetheretherketone.
18. The apparatus of claim 1, wherein at least one of the first
endplate, the second endplate, the first lateral spacer and the
second lateral spacer includes a marker comprising a material which
is substantially opaque to x-rays.
19. The apparatus of claim 1, further comprising at least one
additional spacer disposed laterally between the first lateral
spacer and the second lateral spacer.
20. The apparatus of claim 1, further comprising a mechanism for
connecting the apparatus to a means for supplemental fixation.
21. The apparatus of claim 20, wherein the means for supplemental
fixation is selected from the group including: (a) one or more
screws; (b) one or more rods; (c) one or more staples; (d) one or
more washers; (e) one or more cross connectors; and (f) one or more
hooks.
22. A method of constructing a vertebral body replacement apparatus
for placement between a first vertebra and a second vertebra,
comprising: selecting a first endplate including a generally
outward facing surface for contacting at least a portion of a lower
face of the first vertebra and a generally inward facing surface
including thereon at least two pockets and at least two
protrusions, wherein at least one protrusion is disposed within
each of the pockets; selecting a second endplate including a
generally outward facing surface for contacting at least a portion
of an upper face of the second vertebra and a generally inward
facing surface including thereon at least two pockets and at least
two protrusions, wherein at least one protrusion is disposed within
each of the pockets; selecting a first lateral spacer including at
least one aperture; selecting a second lateral spacer including at
least one aperture; and placing the first and second lateral
spacers between the first and second endplates such that the first
endplate is above the first and second lateral spacers and the
second endplate is below the first and second lateral spacers and
such that a first pair of opposed pockets of the first and second
endplates receive therein at least a part of the first lateral
spacer and a second pair of opposed pockets of the first and second
endplates receive therein at least a part of the second lateral
spacer; wherein the aperture of the first lateral spacer receives
at least one of the protrusions of each of the first and second
endplates when the first lateral spacer is received within the
first pair of pockets and the aperture of the second lateral spacer
receives at least one of the protrusions of each of the first and
second endplates when the second lateral spacer is received within
the second pair of pockets.
23. The method of claim 22, wherein at least one of: (a) the mating
of each of the protrusions with a respective one of the apertures
provides lateral alignment between each of the first endplate, the
second endplate, the first lateral spacer and the second lateral
spacer; and (b) the mating of each of the lateral spacers with a
respective pocket provides lateral alignment between each of the
first endplate, the second endplate, the first lateral spacer and
the second lateral spacer.
24. The method of claim 23, wherein at least one of the protrusions
and at least one of a respective one of the apertures includes a
locking mechanism for locking the protrusion in the aperture.
25. The method of claim 24, wherein the locking mechanism of the
protrusion and the locking mechanism of the aperture are configured
to permit unlocking thereof.
26. The method of claim 22, wherein the aperture of the first
lateral spacer extends through the first lateral spacer and the
aperture of the second lateral spacer extends through the second
lateral spacer.
27. The method of claim 22, wherein each of the first and second
lateral spacers includes a respective upper aperture adjacent the
generally inward facing surface of the first endplate for receiving
at least one of the protrusions of the first endplate and each of
the first and second lateral spacers includes a respective lower
aperture adjacent the generally inward facing surface of the second
endplate for receiving at least one of the protrusions of the
second endplate.
28. The method of claim 22, wherein the steps are carried out in
the order recited.
29. A method of stabilizing a spine, comprising: selecting, for a
vertebral body replacement apparatus, a first endplate including a
generally outward facing surface for contacting at least a portion
of a lower face of the first vertebra and a generally inward facing
surface including thereon at least two pockets and at least two
protrusions, wherein at least one protrusion is disposed within
each of the pockets; selecting, for the vertebral body replacement
apparatus, a second endplate including a generally outward facing
surface for contacting at least a portion of an upper face of the
second vertebra and a generally inward facing surface including
thereon at least two pockets and at least two protrusions, wherein
at least one protrusion is disposed within each of the pockets;
selecting, for the vertebral body replacement apparatus, a first
lateral spacer including at least one aperture; selecting, for the
vertebral body replacement apparatus, a second lateral spacer
including at least one aperture; constructing the vertebral body
replacement apparatus by placing the first and second lateral
spacers between the first and second endplates such that the first
endplate is above the first and second lateral spacers and the
second endplate is below the first and second lateral spacers, such
that a first pair of opposed pockets of the first and second
endplates receive therein at least a part of the first lateral
spacer and a second pair of opposed pockets of the first and second
endplates receive therein at least a part of the second lateral
spacer, such that the aperture of the first lateral spacer receives
at least one of the protrusions of each of the first and second
endplates when the first lateral spacer is received within the
first pair of pockets and such that the aperture of the second
lateral spacer receives at least one of the protrusions of each of
the first and second endplates when the second lateral spacer is
received within the second pair of pockets; and placing the
vertebral body replacement apparatus between the first and second
vertebrae.
30. The method of claim 29, wherein the vertebral body replacement
apparatus is configured to be placed in one of the thoracic and
lumbar spinal regions.
31. The method of claim 29, wherein the steps are carried out in
the order recited.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation in part of U.S.
application Ser. No. 10/968,586 filed Oct. 19, 2004, which claims
the benefit under 35 U.S.C. 119(e) of U.S. Provisional Application
Ser. No. 60/512,716, filed Oct. 20, 2003.
FIELD OF THE INVENTION
[0002] Various embodiments of the present invention relate to an
apparatus for vertebral body replacement and methods associated
therewith.
[0003] In one embodiment, a vertebral body replacement apparatus
may be used to correct and stabilize the spine (e.g., the
thoracolumbar spine (T1-L5)).
[0004] In another embodiment, a vertebral body (e.g., a diseased
and/or damaged vertebral body) that has been resected or excised
(e.g., for the treatment of a tumor or trauma) may be replaced
(with the height of the resected or excised vertebral body being
substantially replaced and restored by the apparatus of the present
invention).
BACKGROUND OF THE INVENTION
[0005] Examples of various patent documents in the spinal implant
area include the following:
[0006] U.S. Pat. No. 5,192,327 to Brantigan relates to a surgical
prosthetic implant for vertebrae. More particularly, surgical
prosthetic modular implants used singularly or stacked together are
provided to support and fuse together adjacent vertebrae or to
totally or partially replace one or more vertebrae in a vertebral
column. The implants are rigid annular plugs, dimensionally similar
to normal vertebral bodies, have simplified oval or hemi-oval
shapes with ridged faces to engage adjacent vertebral bodies to
resist displacement and allow bone ingrowth and fusion and to
interdigitate with the ridges of an adjacent plug for modular
stacking to allow variability of ultimate implant height. The
implants can be provided in sets of different thicknesses and are
internally grooved to receive an upstanding connecting bar to bind
together the individual stacked implants into a stable unit. The
annular implants have ample spaces to allow ingrowth of blood
capillaries and packing of bone graft and are preferably made of a
radiolucent material, preferably biocompatible carbon fiber
reinforced polymers or are alternately made of traditional
orthopaedic implant materials such as nickel, chromium, cobalt,
stainless steel or titanium.
[0007] U.S. Pat. No. 5,397,364 to Kozak et al. relates to an
anterior interbody fusion device. More particularly, an interbody
fusion device includes a pair of lateral spacers and a pair of
central spacers, each sized for percutaneous introduction through a
disc resection portal in the disc annulus. Each of the lateral
spacers includes opposing side faces defining a channel therein,
while each of the central spacers includes arms at their opposite
ends configured to be received within a channel of a corresponding
lateral spacer. The arms and channels are interlocking to prevent
separation of the components once assembled within the intradiscal
space. The assembly of the central and lateral spacers defines a
cavity therebetween for insertion of bone graft material. The
central and lateral spacers are configured so that the bone graft
cavity is oriented over the weakest, but most vascular and
biologically active, bone of the vertebral body, while the lateral
spacers are situated adjacent the disc annulus and over the
strongest vertebral bone.
[0008] U.S. Pat. No. 6,159,211 to Boriani et al. relates to a
stackable cage system for corpectomy/vertebrectomy. More
particularly, surgical prosthetic modular devices used singularly
or stacked together are provided for use to replace excised
vertebral tissue. The devices are rigid plugs, dimensionally
similar to normal vertebral bodies, and have ridged faces to engage
adjacent vertebral bodies or to interdigitate when stacked. Ridges
extend in both the medial/lateral and anterior/posterior directions
to prevent slipping in the anterior/posterior and medial/lateral
directions respectively. A locking screw may be used to secure a
stack to form a singular rigid prosthetic device. The devices are
also provided with a plurality of threaded openings. In the method
of this invention, a device is used to replace excised vertebral
tissue, threaded bolts are inserted into the threaded openings, and
other spine stabilization devices are attached to the bolts. In
corporectomies, the device can be bolted to a plate, which in turn
is fixed to adjacent vertebrae. In spondylectomies, the device can
be fixed to a series of posteriorly placed rods.
[0009] U.S. Pat. No. 6,468,311 to Boyd et al. relates to a modular
interbody fusion implant. More particularly, an interbody fusion
device for engagement between vertebrae includes a pair of lateral
spacers for spacing the vertebrae, and a connecting member adapted
to couple together the lateral spacers when inserted between the
vertebrae. The connecting member, individual lateral spacers, or
the entire spinal spacer can be made of bone in order to promote
fusion of the vertebrae. The modular construction permits use of
bone segments otherwise unsuitable due to size or strength in
stable fusion devices.
[0010] U.S. Patent Application No. 2003/0040799 in the name of Boyd
et al. relates to a modular interbody fusion implant. More
particularly, an interbody fusion device for engagement between
vertebrae includes a pair of lateral spacers for spacing the
vertebrae, and a connecting member adapted to couple together the
lateral spacers when inserted between the vertebrae. The connecting
member, individual lateral spacers, or the entire spinal spacer can
be made of bone in order to promote fusion of the vertebrae. The
modular construction permits use of bone segments otherwise
unsuitable due to size or strength in stable fusion devices.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] FIG. 1 shows a perspective view of one embodiment of a
vertebral body replacement implant assembly according to the
present invention;
[0012] FIG. 2 shows another view of the implant assembly of FIG. 1
as it would look outside of the body;
[0013] FIGS. 3A and 3B show exploded perspective views of the
implant assembly of FIGS. 1 and 2 (FIG. 3A shows an embodiment of
the implant assembly from one angle and FIG. 3B shows an embodiment
of the implant assembly from another angle);
[0014] FIG. 4 shows a perspective view of an endplate type
component of an implant assembly according to an embodiment of the
present invention;
[0015] FIG. 5 shows a perspective view of a non-lordotic lateral
spacer type component of an implant assembly according to an
embodiment of the present invention;
[0016] FIG. 6 shows a perspective view of a lordotic lateral spacer
type component of an implant assembly according to an embodiment of
the present invention;
[0017] FIG. 7 shows a plan view of an implant assembly according to
an embodiment of the present invention;
[0018] FIG. 8 shows section A-A of FIG. 7;
[0019] FIG. 9 shows Detail B of FIG. 8;
[0020] FIG. 10 shows a plan view of another embodiment of the
present invention;
[0021] FIGS. 11-14 show perspective views of other embodiments of
the present invention;
[0022] FIGS. 15 and 16 show, respectively, a perspective view and
an exploded perspective view of another embodiment of the present
invention;
[0023] FIGS. 17A-17G show perspective views of various components
according to an embodiment of the present invention;
[0024] FIGS. 18, 19A, 19B, 20A, 20B and 21 show perspective views
of various implant assemblies using the components of FIGS.
17A-17G;
[0025] FIGS. 22A-22E show various views of an implant assembly
using the components of FIGS. 17A-17G;
[0026] FIG. 23 shows a perspective view of another embodiment of a
vertebral body replacement implant assembly according to the
present invention;
[0027] FIG. 24 shows another view of the implant assembly of FIG.
23 as it would look outside of the body;
[0028] FIG. 25 shows an exploded perspective view of the implant
assembly of FIGS. 23 and 24;
[0029] FIG. 26 shows a perspective view of an endplate type
component of an implant assembly according to an embodiment of the
present invention;
[0030] FIG. 27 shows a perspective view of a non-lordotic lateral
spacer type component of an implant assembly according to an
embodiment of the present invention;
[0031] FIG. 28 shows a perspective view of a lordotic lateral
spacer type component of an implant assembly according to an
embodiment of the present invention;
[0032] FIG. 29 shows a plan view of an implant assembly according
to an embodiment of the present invention;
[0033] FIG. 30 shows section B-B of FIG. 29; and
[0034] FIG. 31 shows Detail C of FIG. 30.
[0035] Among those benefits and improvements that have been
disclosed, other objects and advantages of this invention will
become apparent from the following description taken in conjunction
with the accompanying figures. The figures constitute a part of
this specification and include illustrative embodiments of the
present invention and illustrate various objects and features
thereof.
DETAILED DESCRIPTION OF THE INVENTION
[0036] Detailed embodiments of the present invention are disclosed
herein; however, it is to be understood that the disclosed
embodiments are merely illustrative of the invention that may be
embodied in various forms. In addition, each of the examples given
in connection with the various embodiments of the invention are
intended to be illustrative, and not restrictive. Further, the
figures are not necessarily to scale, some features may be
exaggerated to show details of particular components. Therefore,
specific structural and functional details disclosed herein are not
to be interpreted as limiting, but merely as a representative basis
for teaching one skilled in the art to variously employ the present
invention.
[0037] Referring now to FIG. 1, one embodiment of a vertebral body
replacement implant assembly according to the present invention is
shown. As seen in this FIG. 1, Implant Assembly 101 may be
implanted between First Vertebra 103a and Second Vertebra 103b
(FIG. 2 shows another view of Implant Assembly 101 as it would look
outside of the body). Of note, Implant Assembly 101 may be formed
of a number of components fitted together.
[0038] More particularly, as seen in FIGS. 3A and 3B, Implant
Assembly 101 may be formed of, for example, four components: (a)
First Endplate 301 (e.g., a top Endplate), Second Endplate 303
(e.g., a bottom Endplate), First Lateral Spacer 305 and Second
Lateral Spacer 307.
[0039] First Endplate 301 may include: First Offset Aperture 301a
(e.g., offset relative to a centerline of Endplate 301); Second
Offset Aperture 301b (e.g., offset relative to a centerline of
Endplate 301); Protrusions 301c and 301d (these Protrusions are
seen most clearly in FIG. 3B; although in this embodiment there are
four such Protrusions (two adjacent First Offset Aperture 301a and
two adjacent Second Offset Aperture 301b) any number of protrusions
may be utilized); Insertion Tool Mating Aperture 301e (for mating
with an insertion tool (not shown)); and various grooves disposed
along the top surface (the grooves are not separately numbered in
the Figs.).
[0040] Likewise, Second Endplate 303 may include: First Offset
Aperture 303a (e.g., offset relative to a centerline of Endplate
303); Second Offset Aperture 303b (e.g., offset relative to a
centerline of Endplate 303); Protrusions 303c-303f; Insertion Tool
Mating Aperture 303g (for mating with an insertion tool (not
shown)); and various grooves disposed along the bottom surface (the
grooves are not separately numbered in the Figs.).
[0041] Further, First Lateral Spacer 305 may include: Main Aperture
305a (which may at least partially line-up with First Offset
Aperture 301a and First Offset Aperture 303a; various Auxiliary
Apertures (not separately numbered in the Figs.); and various
grooves disposed along the top surface and the bottom surface (the
grooves are not separately numbered in the Figs.).
[0042] Likewise, Second Lateral Spacer 307 may include: Main
Aperture 307a (which may at least partially line-up with Second
Offset Aperture 301b and Second Offset Aperture 303b; various
Auxiliary Apertures (not separately numbered in the Figs.); and
various grooves disposed along the top surface and the bottom
surface (the grooves are not separately numbered in the Figs.).
[0043] Of note, the embodiments of FIGS. 3A and 3B are similar,
with the main differences being the shape of the internal
centerline bosses on the inner faces of the First Endplate and
Second Endplate and the fact that the Protrusions in the embodiment
of FIG. 3A are essentially featureless (such that they provide
lateral alignment/support) while the Protrusions of the embodiment
of FIG. 3B provide locking features such as the ridges shown in the
Fig. but not separately numbered (such that the ridges cooperate
with mating indentations (shown in the Fig. but not separately
numbered) in the First Lateral Spacer and the Second Lateral Spacer
to provide both lateral alignment/support as well as up-down
locking (e.g., removable locking) of the components). In another
example (which example is intended to be illustrative and not
restrictive), a tab and slot system may be utilized for
locking.
[0044] Of further note, Implant Assembly 101 may provide for bony
ingrowth and/or may be packed with bone matter. This may be
accomplished via the hollow fenestrated design of the components
(e.g., via First Offset Aperture 301a; Second Offset Aperture 301b;
First Offset Aperture 303a; Second Offset Aperture 303b; Main
Aperture 305a; Main Aperture 307a; and/or the various Auxiliary
Apertures) and/or the hollow fenestrated design of the finished
implant assembly (e.g., via the space(s) between First Lateral
Spacer 305 and Second Lateral Spacer 307 at each end of the
finished implant assembly).
[0045] In one set of examples (which examples are intended to be
illustrative and not restrictive), Implant Assembly 101 may be
provided in two footprint sizes. The "small" footprint may measure,
for example, 28 mm wide.times.23 mm length (in this example each
"small" footprint size Endplate may be 28 mm wide.times.23 mm
length, and each Lateral Spacer may be 8 mm wide.times.23 mm
length). The "large" footprint may measure, for example, 35 mm
wide.times.28 mm length (in this example each "large" footprint
size Endplate may be 35 mm wide.times.28 mm length, and each
Lateral Spacer may be 8 mm wide.times.28 mm length). One or both
footprint sizes may be available in height ranges from, for
example, 12 mm to 60 mm (in increments of one millimeter, for
example).
[0046] Reference will now be made to Tables 1-3, below, which
identify example thicknesses of the components of a "large" implant
assembly (of course, these examples are intended to be illustrative
and not restrictive). More particularly, Table 1 identifies example
thicknesses of a "large" End Plate (see, e.g., FIG. 4 for a
perspective view of this type of component), Table 2 identifies
example thicknesses of a "large" Non-Lordotic Lateral Spacer (see,
e.g., FIG. 5 for a perspective view of this type of component) and
Table 3 identifies example thicknesses of a "large" Lordotic
Lateral Spacer (see, e.g., FIG. 6 for a perspective view of this
type of component).
1TABLE 1 (All measurements in mm) 2 3 4
[0047]
2TABLE 2 (All measurements in mm) 8 10 12 14 16 21 26 31 36 41 46
51 56
[0048]
3TABLE 3 (All measurements in mm) 8 10 12 14 16 21 26 31 36 41 46
51 56
[0049] Reference will now be made to Tables 4-6, below, which
identify example thicknesses of the components of a "small" implant
assembly (of course, these examples are intended to be illustrative
and not restrictive). More particularly, Table 4 identifies example
thicknesses of a "small" End Plate (see, e.g., FIG. 4 for a
perspective view of this type of component), Table 5 identifies
example thicknesses of a "small" Non-Lordotic Lateral Spacer (see,
e.g., FIG. 5 for a perspective view of this type of component) and
Table 6 identifies example thicknesses of a "small" Lordotic
Lateral Spacer (see, e.g., FIG. 6 for a perspective view of this
type of component).
4TABLE 4 (All measurements in mm) 2 3 4
[0050]
5TABLE 5 (All measurements in mm) 8 10 12 14 16 21 26 31 36 41 46
51 56
[0051]
6TABLE 6 (All measurements in mm) 8 10 12 14 16 21 26 31 36 41 46
51 56
[0052] Referring now to construction of the implant assembly from
its constituent components, it is noted that in one embodiment such
construction may occur outside of the patient's body (e.g., outside
of the wound). More particularly, after determining the correct
height, footprint and/or lordotic requirement of the implant
assembly, the surgeon may then select one or more lateral spacers
(e.g., two) and/or one or more endplates (e.g., two) that would
meet the requirements (e.g., a 30 mm tall implant assembly may
utilize two lateral spacers of 26 mm tall and two 2 mm thick
endplates). The components may be assembled by snapping the lateral
spacers onto a first endplate and then snapping a second endplate
onto the two lateral spacers. Such snapping construction may be
carried out, for example, using a lip and undercut arrangement (see
FIG. 7 (showing a plan view of an implant assembly according to an
embodiment of the present invention), FIG. 8 (showing section A-A
of FIG. 7), and FIG. 9 (showing Detail B of FIG. 8)). More
particularly, with regard to such snapping construction, attention
is directed to the features of FIG. 9 which show the undercut in
the lateral spacer and the tapered lip on the endplate (wherein an
interference may exist in the assembly until the tapered lip
reaches the undercut and snaps into place creating a lock).
[0053] In another embodiment, some or all of the components may
include or be made essentially entirely from polyetheretherketone
(e.g., PEEK Optima). Of note, this PEEK polymer material has
radiolucent properties, which may aid the surgeon in determining if
fusion (e.g., in the operative site) has occurred. Since such PEEK
material is essentially transparent to x-rays, markers (e.g.,
markers made of titanium) may be inserted into one or more of the
components to give a surgeon a visual aid in determining the
location of the component and/or entire implant assembly (e.g.,
both inter and postoperatively).
[0054] In another embodiment, Indications relating to use of the
present invention may include (but not be limited to):
[0055] For use in thoracolumbar spine (i.e., T1 to L5) to replace a
vertebral body (e.g., a diseased vertebral body) resected or
excised (e.g., for the treatment of tumor(s)) to achieve anterior
decompression of the spinal cord and neural tissues, and to restore
the height of a collapsed vertebral body.
[0056] For treating fracture(s) of the thoracic and/or lumbar
spine.
[0057] To restore the biomechanical integrity of the anterior,
middle, and/or posterior spinal column (e.g., even in the absence
of fusion for a prolonged period).
[0058] For use with supplemental internal fixation. Such
supplemental internal fixation may include (but not be limited to)
any appropriate screws, rods, staples, washers, cross connectors,
and/or posterior hooks.
[0059] In another embodiment, Contraindications relating to use of
the present invention may include (but not be limited to):
[0060] Morbid obesity
[0061] Mental illness
[0062] Alcoholism and/or drug abuse
[0063] Pregnancy
[0064] Mental sensitivity/allergies
[0065] Severe osteopenia
[0066] Patients unwilling or unable to follow post-operative care
instructions
[0067] Certain circumstances not identified above as an Indication
(e.g., as identified by any appropriate care giver)
[0068] In another embodiment, one or more of the components and/or
the implant assembly may have a tapered lead-in (e.g., for easy
insertion).
[0069] In another embodiment, each lateral spacer may be capable of
supporting the vertebral column.
[0070] In another embodiment, the textured surface of the
components and/or the implant assembly may allow for easy insertion
and/or resistance to expulsion (see FIGS. 10-14 for additional
textured surface examples (which examples are intended to be
illustrative and not restrictive)).
[0071] In another embodiment, multiple lateral spacer type
components may be assembled in a "bridge" configuration (see FIGS.
15 and 16, for example).
[0072] In another embodiment, the components may be assembled as
desired (see FIGS. 17A-17G, 18, 19A, 19B, 20A, 20B, 21 and 22A-22E,
for example).
[0073] Referring now to FIG. 23, another embodiment of a vertebral
body replacement implant assembly according to the present
invention is shown. As seen in this FIG. 23, Implant Assembly 2301
may be implanted between First Vertebra 2303a and Second Vertebra
2303b (FIG. 24 shows another view of Implant Assembly 2301 as it
would look outside of the body). Of note, Implant Assembly 2301 may
be formed of a number of components fitted together.
[0074] More particularly, as seen in FIG. 25, Implant Assembly 2301
may be formed of, for example, four components: (a) First Endplate
2501 (e.g., a top Endplate), Second Endplate 2503 (e.g., a bottom
Endplate), First Lateral Spacer 2505 and Second Lateral Spacer
2507.
[0075] First Endplate 2501 may include: First Offset Aperture 2501a
(e.g., offset relative to a centerline of Endplate 2501); Second
Offset Aperture 2501b (e.g., offset relative to a centerline of
Endplate 2501); Protrusions 2501c and 2501d (these Protrusions are
not seen in this Fig. but are similar to the Protrusions of Second
Endplate 2503 discussed below--although in this embodiment there
are four such Protrusions (two adjacent First Offset Aperture 2501a
and two adjacent Second Offset Aperture 2501b) any number of
protrusions may be utilized); Insertion Tool Mating Aperture 2501e
(for mating with an insertion tool (not shown)); and various
grooves disposed along the top surface (the grooves are not
separately numbered in the Figs.).
[0076] Likewise, Second Endplate 2503 may include: First Offset
Aperture 2503a (e.g., offset relative to a centerline of Endplate
2503); Second Offset Aperture 2503b (e.g., offset relative to a
centerline of Endplate 2503); Protrusions 2503c-2503f; Insertion
Tool Mating Aperture 2503g (for mating with an insertion tool (not
shown)); and various grooves disposed along the bottom surface (the
grooves are not separately numbered in the Figs.).
[0077] Further, First Lateral Spacer 2505 may include: Main
Aperture 2505a (which may at least partially line-up with First
Offset Aperture 2501b and First Offset Aperture 2503b; various
Auxiliary Apertures (not separately numbered in the Figs.); and
various grooves disposed along the top surface and the bottom
surface (the grooves are not separately numbered in the Figs.).
[0078] Likewise, Second Lateral Spacer 2507 may include: Main
Aperture 2507a (which may at least partially line-up with Second
Offset Aperture 2501a and Second Offset Aperture 2503a; various
Auxiliary Apertures (not separately numbered in the Figs.); and
various grooves disposed along the top surface and the bottom
surface (the grooves are not separately numbered in the Figs.).
[0079] Of note, the embodiments of FIGS. 25 and 3A/3B are similar,
with the main differences being that in the embodiment of FIG. 25
each of First Endplate 2501 and Second Endplate 2503 includes
pockets into which each of First Lateral Spacer 2505 and Second
Lateral Spacer 2507 fits (Pockets 2503h and 2503i are individually
identified in FIG. 25 in connection with Second Endplate
2503--First Endplate 2501 has similar pockets which are not seen in
this view).
[0080] In one example (which example is intended to be illustrative
and not restrictive), the pockets may provide (either alone or in
combination with the protrusions) lateral alignment/support of the
components. In another example (which example is intended to be
illustrative and not restrictive), the pockets may provide (either
alone or in combination with the protrusions) both lateral
alignment/support of the components as well as up-down locking
(e.g., removable locking) of the components. In another example
(which example is intended to be illustrative and not restrictive),
a tab and slot system may be utilized for locking.
[0081] Of further note, Implant Assembly 2301 may provide for bony
ingrowth and/or may be packed with bone matter. This may be
accomplished via the hollow fenestrated design of the components
(e.g., via First Offset Aperture 2501a; Second Offset Aperture
2501b; First Offset Aperture 2503a; Second Offset Aperture 2503b;
Main Aperture 2505a; Main Aperture 2507a; and/or the various
Auxiliary Apertures) and/or the hollow fenestrated design of the
finished implant assembly (e.g., via the space(s) between First
Lateral Spacer 2505 and Second Lateral Spacer 2507 at each end of
the finished implant assembly).
[0082] Referring now to FIGS. 26-28, it is noted that these Figs.
show, respectively, a perspective view of an endplate according to
an embodiment of the present invention, a perspective view of a
non-lordotic lateral spacer according to an embodiment of the
present invention and a perspective view of a lordotic lateral
spacer according to an embodiment of the present invention.
[0083] Referring now to construction of the implant assembly it is
noted, as discussed above, that the lateral spacers may be snapped
onto a first endplate and then a second endplate may be snapped
onto the two lateral spacers. Such snapping construction may be
carried out, for example, using a lip and undercut arrangement (see
FIG. 29 (showing a plan view of an implant assembly according to an
embodiment of the present invention), FIG. 30 (showing section B-B
of FIG. 29), and FIG. 31 (showing Detail C of FIG. 30)). More
particularly, with regard to such snapping construction, attention
is directed to the features of FIG. 31 which show the undercut in
the lateral spacer and the tapered lip on the endplate (wherein an
interference may exist in the assembly until the tapered lip
reaches the undercut and snaps into place creating a lock).
[0084] While a number of embodiments of the present invention have
been described, it is understood that these embodiments are
illustrative only, and not restrictive, and that many modifications
may become apparent to those of ordinary skill in the art. For
example, an implant assembly according to the present invention may
be tested in accordance with ASTM F 2077-03 "Test Methods For
Intervertebral Body Fusion Devices" (or a modified version thereof)
and/or the FDA's Sep. 27, 2000 "Guidance for Spinal Systems
510(k)'s. Further, the lordotic angle may be any desired angle
(e.g., 4.degree.-8.degree.). Further still, one or more components
may be used separately from an implant assembly (e.g., one or more
of the lateral spacers (non-lordotic and/or lordotic) may be
implanted directly into the spine without use of a top and/or
bottom endplate). Further still, the various components may take
different shapes as desired and the various features may take on
various specifics as desired (e.g., the various apertures may be of
any desired number and/or shape). Further still, the apparatus
(and/or its components) may, of course, have any desired dimensions
(e.g., for any desired patient--man, woman or child). Further
still, the apparatus (and/or its components) may be provided in a
"line" or "family" of devices (e.g., small, medium and large;
adult, child; male, female). Further still, the apparatus (and/or
its components) may be provided in standard sizes. Further still,
any desired locking mechanism(s) may be used to hold the various
components together and/or in desired alignment. Further still,
such locking may be capable of being unlocked (e.g., a mechanism
and/or tool may be provided for unlocking the various components).
Further still, lateral spacers(s) may be disposed adjacent one or
more central spacers. Further still, any steps relating to
manufacture and/or use may be performed in any desired order.
* * * * *