U.S. patent application number 12/804012 was filed with the patent office on 2010-11-11 for expandable spinal fusion cage and associated instrumentation.
Invention is credited to Bret M. Berry, Randall F. Dryer, Eric C. Lange.
Application Number | 20100286780 12/804012 |
Document ID | / |
Family ID | 36295517 |
Filed Date | 2010-11-11 |
United States Patent
Application |
20100286780 |
Kind Code |
A1 |
Dryer; Randall F. ; et
al. |
November 11, 2010 |
Expandable spinal fusion cage and associated instrumentation
Abstract
An expandable spinal implant comprising a cage body including at
least two movable branches having first end portions that are
interconnected to one another and second end portions that are
movable relative to one another. The movable branches include a
first shell portion having a first pair of longitudinal edges and
defining a first hollow region therebetween, and a second shell
portion having a second pair of longitudinal edges and defining a
second hollow region therebetween, with the first and second hollow
regions cooperating to define at least a portion of a hollow
interior of the cage body. An expansion member co-acts with the
first and second shell portions to transition the cage body to an
expanded configuration as the expansion member is axially displaced
along said first and second pairs of longitudinal edges. In one
embodiment, at least one of the shell portions defines a plurality
of retention elements positioned at select axial locations along a
corresponding one of the longitudinal edges, with the expansion
member engaged with one or more of the retention elements to retain
the expansion member at a select axial position to maintain the
implant in the expanded configuration.
Inventors: |
Dryer; Randall F.; (Austin,
TX) ; Berry; Bret M.; (Sandy, UT) ; Lange;
Eric C.; (Collierville, TN) |
Correspondence
Address: |
MEDTRONIC;Attn: Noreen Johnson - IP Legal Department
2600 Sofamor Danek Drive
MEMPHIS
TN
38132
US
|
Family ID: |
36295517 |
Appl. No.: |
12/804012 |
Filed: |
July 12, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12590371 |
Nov 6, 2009 |
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12804012 |
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11335261 |
Jan 19, 2006 |
7655046 |
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12590371 |
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60645299 |
Jan 20, 2005 |
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Current U.S.
Class: |
623/17.11 |
Current CPC
Class: |
A61F 2002/30594
20130101; A61F 2002/2817 20130101; A61F 2210/0004 20130101; A61F
2310/00359 20130101; A61F 2002/30593 20130101; A61F 2250/0006
20130101; A61F 2002/30624 20130101; A61F 2310/00023 20130101; A61F
2/4611 20130101; A61F 2002/30507 20130101; A61F 2/446 20130101;
A61F 2002/2835 20130101; A61F 2310/00017 20130101; A61F 2002/4629
20130101; A61F 2002/30774 20130101; A61F 2/28 20130101; A61F
2310/00029 20130101; A61F 2220/0025 20130101; A61F 2002/30841
20130101; A61F 2002/30858 20130101; A61F 2002/30062 20130101; A61F
2002/30777 20130101; A61F 2002/30522 20130101; A61F 2002/30538
20130101; A61F 2002/4628 20130101; A61F 2002/30789 20130101; A61F
2002/30579 20130101; A61F 2002/4627 20130101 |
Class at
Publication: |
623/17.11 |
International
Class: |
A61F 2/44 20060101
A61F002/44 |
Claims
1.-37. (canceled)
38. A surgical method, comprising: providing an expandable spinal
implant comprising a cage body having a hollow inner chamber, the
spinal implant having a length extending along a longitudinal axis
and defining an outer cross section having a first transverse
dimension defined by a first pair of oppositely facing surfaces
extending substantially entirely along the length and a second
transverse dimension defined by a second pair of oppositely facing
surfaces extending between the first pair of oppositely facing
surfaces, the second transverse dimension sized greater than the
first transverse dimension; inserting the spinal implant into an
intervertebral space with the first transverse dimension generally
aligned along a height of the intervertebral space; orienting the
spinal implant within the intervertebral space to generally align
the second transverse dimension along the height of the
intervertebral space; and expanding the spinal implant along at
least the second transverse dimension.
39. The method of claim 38, wherein the orienting comprises
rotating the expandable spinal implant 90 degrees about the
longitudinal axis.
40. The method of claim 38, wherein the expanding occurs subsequent
to the orienting.
41. The method of claim 38, further comprising: reorienting the
spinal implant within the intervertebral space to generally realign
the first transverse dimension along the height of the
intervertebral space; and removing the spinal implant from the
intervertebral space.
42. The method of claim 41, wherein the reorienting is accomplished
without collapsing the spinal implant along the second transverse
dimension.
43. The method of claim 41, further comprising reinserting the
spinal implant into the intervertebral space with the first
transverse dimension generally aligned along the height of the
intervertebral space and reorienting the spinal implant within the
intervertebral space to generally align the second transverse
dimension along the height of the intervertebral space.
44. The method of claim 38, wherein the second pair of oppositely
facing surfaces comprises a pair of opposite arcuate surfaces and
the first pair of oppositely facing surfaces comprises a pair of
opposite generally planar surfaces extending between the pair of
arcuate surfaces; and wherein a distance between the pair of planar
surfaces defines the first transverse dimension and a distance
between the pair of arcuate surfaces defines the second transverse
dimension.
45. The method of claim 38, further comprising positioning a bone
growth promoting material within the inner chamber.
46. The method of claim 45, wherein the positioning of the bone
growth promoting material within the inner chamber occurs prior to
the inserting.
47. The method of claim 44, wherein the pair of arcuate surfaces
comprise convex outer surfaces; and wherein the generally planar
surfaces each extending from one of the convex outer surfaces to
the opposite convex outer surface.
48. The method of claim 38, wherein the second pair of opposite
surfaces comprise a pair of opposite arcuate surfaces that each
define external threads.
49. The method of claim 38, wherein the second pair of oppositely
facing surfaces comprise a pair of opposite arcuate surfaces; and
wherein the first pair of oppositely facing surfaces comprises a
pair of truncated side portions arranged generally opposite one
another and peripherally interrupting and extending between the
pair of opposite arcuate surfaces.
50. The method of claim 49, wherein the pair of opposite arcuate
surfaces each define external threads.
51. The method of claim 49, wherein the pair of truncated side
portions are defined by a pair of opposite generally planar
surfaces extending between the pair of opposite arcuate
surfaces.
52. The method of claim 38, wherein the cage body includes at least
two movable branches each having first end portions that are
interconnected to one another and opposite second end portions that
are movable relative to one another, the movable branches including
inner surfaces cooperating with one another to define the hollow
inner chamber of the cage body, the cage body including: a first
shell portion having a first pair of longitudinal edges and
defining a first hollow region between the first pair of
longitudinal edges; a second shell portion having a second pair of
longitudinal edges and defining a second hollow region between the
second pair of longitudinal edges, the first hollow region of the
first shell portion cooperating with the second hollow region of
the second shell portion to define at least a portion of the hollow
inner chamber of the cage body; and further comprising providing an
expansion member and slidably engaging the expansion member
simultaneously along the first and second pairs of longitudinal
edges of the first and second shell portions which results in the
expanding of the spinal implant along the second transverse
dimension as the expansion member is axially displaced between
opposing ones of the first and second pairs of longitudinal
edges.
53. The method of claim 52, wherein the first and second pairs of
longitudinal edges are arranged transversely opposite one another
with the first pair of longitudinal edges extending generally along
a first plane and the second pair of longitudinal edges extending
generally along a second plane.
54. The method of claim 52, wherein at least one of the
longitudinal edges of the first and second shell portions defines
one or more retention elements positioned at select axial
locations, the expansion member engaged with at least one of said
retention elements to retain the expansion member at a select axial
position between the first and second shell portions and to
maintain said cage body in a transversely expanded
configuration.
55. The method of claim 52, wherein the second pair of oppositely
facing surfaces comprise a pair of opposite arcuate surfaces, and
the first pair of oppositely facing surfaces comprises a pair of
truncated side portions arranged generally opposite one another and
peripherally interrupting and extending between the pair of
opposite arcuate surfaces; and wherein each of the at least two
movable branches defines one of the outer arcuate surfaces and a
portion of each of the truncated side portions.
56. The method of claim 55, wherein the truncated side portions
comprise substantially planar outer surfaces extending between the
pair of opposite arcuate surfaces.
57. The method of claim 52, wherein each of the first and second
shell portions has a substantially semi-cylindrical shape; and
wherein the first and second shell portions cooperate with one
another to provide the cage body with a substantially cylindrical
configuration with the hollow regions of the first and second shell
portions defining at least a portion of the hollow inner chamber of
the cage body.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] The present application claims the benefit of U.S.
Provisional Patent Application Ser. No. 60/645,299 filed on Jan.
20, 2005, the contents of which are hereby incorporated by
reference in their entirety.
FIELD OF THE INVENTION
[0002] The present invention relates generally to the field of
spinal implants, and more particularly relates to an expandable
spinal fusion cage and associated instrumentation.
BACKGROUND
[0003] There have been numerous attempts to develop a spinal
implant to replace a damaged or degenerated natural spinal disc and
to maintain sufficient stability of the disc space between adjacent
vertebrae, at least until arthrodesis is achieved. These types of
spinal implants have taken many forms.
[0004] For example, spinal implants can either be solid, sometimes
referred to as a spacer or plug, or can define a hollow interior
designed to permit bone in-growth, sometimes referred to as a
fusion device or fusion cage. The interior of a fusion device may
be filled with a bone growth inducing substance to facilitate or
promote bone growth into and through the device. It is commonly
accepted that spinal implants that facilitate or promote natural
bone in-growth typically achieve a more rapid and stable
arthrodesis. Some spinal implant designs are inserted into the disc
space via a threading technique, while other designs are inserted
into the disc space via a push-in or impaction technique.
[0005] One area that is usually not addressed by the
above-discussed spinal implant designs concerns maintaining and
restoring the natural anatomy of the fused spinal segment. Notably,
once natural disc material is removed, the normal lordotic or
kyphotic curvature of the spine is reduced or eliminated. With
regard to prior spinal implants having a substantially uniform
height, the need to restore this curvature is largely neglected.
Additionally, in some cases, the adjacent vertebral bodies are
reamed to form a passage having a shape corresponding to the
particular shape of the spinal implant. In other cases, the normal
curvature is established prior to reaming followed by insertion of
the spinal implant. However, these techniques generally involve
over-reaming of the posterior portion of the adjacent vertebral
bodies, thereby resulting in excessive removal of load bearing
vertebral bone which may lead to instability of the portion of the
spinal column being treated. Also, it is typically difficult to
ream through the posterior portion of the lower lumbar segment
where lordosis is the greatest. As a result, limited effort or in
some cases no effort has been made to restore the lordotic
curvature. Consequently, a spinal curvature deformity may form as
the vertebral bodies settle around the spinal implant.
[0006] Thus, there is a general need in the industry to provide an
improved spinal implant and associated instrumentation. The present
invention satisfies this need and provides other benefits and
advantages in a novel and unobvious manner.
SUMMARY
[0007] The present invention relates generally to a spinal implant
and associated instrumentation. While the actual nature of the
invention covered herein can only be determined with reference to
the claims appended hereto, certain forms of the invention that are
characteristic of the preferred embodiments disclosed herein are
described briefly as follows.
[0008] In one form of the present invention, a spinal fusion cage
is provided that is transitionable from an initial configuration to
an expanded configuration via displacement of an expansion member
between two or more branch portions of the fusion cage.
[0009] In another form of the present invention, instrumentation is
provided for inserting a spinal fusion cage into an intervertebral
opening and for transitioning the fusion cage from an initial
configuration to an expanded configuration via displacement of an
expansion member between two or more branch portions of the fusion
cage.
[0010] In another form of the present invention, a method is
provided for inserting a spinal fusion cage into an intervertebral
opening and for transitioning the fusion cage from an initial
configuration to an expanded configuration via displacement of an
expansion member between two or more branch portions of the fusion
cage.
[0011] It is one object of the present invention to provide an
improved spinal implant and instrumentation associated therewith.
Further objects, features, advantages, benefits, and aspects of the
present invention will become apparent from the drawings and
description contained herein.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1 is a side perspective view of an expandable fusion
cage assembly according to one form of the present invention.
[0013] FIG. 2 is a side view of a fusion cage according to one
embodiment of the present invention for use in association with the
expandable fusion cage assembly illustrated in FIG. 1.
[0014] FIG. 3 is a top view of the fusion cage illustrated in FIG.
2.
[0015] FIG. 4 is a first end view of the fusion cage illustrated in
FIG. 2.
[0016] FIG. 5 is a second end view of the fusion cage illustrated
in FIG. 2.
[0017] FIG. 6 is a cross-sectional side view of the fusion cage
illustrated in FIG. 2, as taken along line 6-6 of FIG. 3.
[0018] FIG. 7 is a side perspective view of an expansion member
according to one embodiment of the present invention for use in
association with the expandable fusion cage assembly illustrated in
FIG. 1.
[0019] FIG. 8 is a side view of the expandable fusion cage assembly
illustrated in FIG. 1, as shown in a non-expanded configuration
with the expansion member disposed at a first operational position
within the fusion cage.
[0020] FIG. 9 is a side view of the expandable fusion cage assembly
illustrated in FIG. 1, as shown in a partially-expanded
configuration with the expansion member disposed at a second
operational position within the fusion cage.
[0021] FIG. 10 is a side view of the expandable fusion cage
assembly illustrated in FIG. 1, as shown in a fully-expanded
configuration with the expansion member disposed at a third
operational position within the fusion cage.
[0022] FIG. 11 is a coronal plane view of the expandable fusion
cage assembly illustrated in FIG. 1, as shown in a first
orientation with the flat side walls of the fusion cage arranged
generally parallel with the endplates of the adjacent
vertebrae.
[0023] FIG. 12 is a coronal plane view of the expandable fusion
cage assembly illustrated in FIG. 1, as shown in a second
orientation with the flat side walls of the fusion cage arranged
generally perpendicular to the endplates of the adjacent
vertebrae.
[0024] FIG. 13 is a cut-away side perspective view, partially in
cross section, of an instrument according to one form of the
present invention for inserting a fusion cage assembly into an
intervertebral disc space and for transitioning the fusion cage
assembly toward an expanded configuration.
[0025] FIG. 14 is a cut-away side perspective view, partially in
cross section, of the distal end portion of the instrument
illustrated in FIG. 13, as positioned adjacent the proximal end
portion of a fusion cage assembly.
[0026] FIG. 15 is a cut-away side perspective view, partially in
cross section, of the distal end portion of the instrument
illustrated in FIG. 13, as engaged to the proximal end portion of
the fusion cage assembly and as engaged to the expansion member for
displacing the expansion member in an axial direction to transition
the fusion cage assembly toward an expanded configuration.
[0027] FIG. 16 is a side perspective view, partially in cross
section, of the distal end portion of the instrument illustrated in
FIG. 13, as shown in a fully extended position to transition the
fusion cage assembly to a fully expanded configuration.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0028] For the purposes of promoting an understanding of the
principles of the invention, reference will now be made to the
embodiments illustrated in the drawings and specific language will
be used to describe the same. It will nevertheless be understood
that no limitation of the scope of the invention is hereby
intended, such alterations and further modifications in the
illustrated devices, and such further applications of the
principles of the invention as illustrated herein being
contemplated as would normally occur to one skilled in the art to
which the invention relates.
[0029] Referring to FIG. 1, shown therein is a spinal implant
assembly 20 according to one form of the present invention. The
spinal implant 20 extends along a longitudinal axis L and is
generally comprised of an expandable fusion cage 22 and an
expansion member 24. As will be discussed below, the expansion
member 24 serves to transition the fusion cage 22 from an initial
configuration (FIGS. 1 and 8) toward an expanded configuration
(FIG. 10). As will also be discussed below, in the illustrated
embodiment of the invention, expansion of the fusion cage 22 occurs
along a transverse axis T so as to distract the disc space and/or
to restore or maintain lordosis between the adjacent vertebral
bodies. However, it should be understood that in other embodiments
of the invention, expansion of the fusion cage 22 may occur in
multiple directions and along multiple axes.
[0030] The components of the spinal implant assembly 20 are each
preferably formed of a biocompatible material. In one embodiment,
the material used to form the fusion cage 22 and/or the expansion
member 24 is a medical grade metallic material, such as, for
example, titanium. However, the use of other metallic materials are
also contemplated, including stainless steel and stainless steel
alloys, titanium and titanium alloys, shape-memory alloys, cobalt
chrome alloys, or any combination of these metallic materials.
Additionally, it should be understood that forming the fusion cage
22 and/or the expansion member 24 from a non-metallic material is
also contemplated. For example, in another embodiment, the fusion
cage 22 and/or the expansion member 24 may be formed of bone or
bone substitute materials. In a further embodiment, the fusion cage
22 and/or the expansion member 24 may be formed of a resorbable
material that resorbs or degrades within the body over a period of
time so as to allow for partial or total replacement by bone. In a
specific embodiment, the fusion cage 22 and/or the expansion member
24 may be formed of a polymeric material, including, for example, a
non-resorbable polymer such as polyetheretherketone (PEEK) or a
resorbable polymer such as polylactates (PLA). Examples of other
suitable materials include composite polymers, non-reinforced
polymers, carbon-reinforced polymer composites, carbon fiber, PMMA,
calcium hydroxide, ceramics, polylactide, polyglycolide,
tyrosine-derived polycarbonate, polyanhydride, polyorthoester,
polyphosphazene, calcium phosphate, calcium hydroxide,
hydroxyapatite, bioactive glass, or any combination of these
materials.
[0031] Referring collectively to FIGS. 1-6, shown therein are
further details regarding the expandable fusion cage 22. The fusion
cage 22 includes a proximal end portion 22a and a distal end
portion 22b. In one embodiment of the invention, the fusion cage 22
is generally comprised of a pair of movable branch portions 26a,
26b extending generally along the longitudinal axis L and
interconnected to one another adjacent the proximal end portion 22b
via a fixed base portion 28. However, it should be understood that
the fusion cage 22 may define any number of branch portions,
including three, four, or five or more branch portions. As will be
discussed below, as the expansion member 24 is displaced relative
to the fusion cage 22, the branch portions 26a, 26b will separate
or splay apart to provide the fusion cage 22 with a cross sectional
dimension adjacent the distal end portion 22b that is greater than
the cross sectional dimension adjacent the proximal end portion
22a.
[0032] In the illustrated embodiment of the invention, the branch
portions 26a, 26b are coupled to the fixed base portion 28 in such
a manner as to allow the branch portions 26a, 26b to move relative
to one another to provide for expansion of the fusion cage 22. In
one embodiment, the branch portions 26a, 26b are formed integral
with the base portion 28 to define a single-piece, unitary fusion
cage 22. In this manner, the base portion 28 flexibly interconnects
the branch portions 26a, 26b so as to allow for expansion of the
fusion cage 22 via flexible material deformation of the branch
portions 26a, 26b and/or the fixed base portion 28. The
interconnection between the fixed base portion 28 and the branch
portions 26a, 26b acts in a hinge-like manner during expansion of
the fusion cage 22 to provide for substantially independent
movement of the branch portions 26a, 26b.
[0033] Although the illustrated embodiment of the fusion cage 22
utilizes integrally connected branch portions 26a, 26b, it is also
contemplated that the branch portions 26a. 26b may be formed
separately and connected together to form a multi-piece fusion cage
assembly.
[0034] In another embodiment, the branch portions 26a, 26b may be
pivotally attached to the base portion 28 or directly to one other
via a hinge or pivot pin such that the fusion cage 22 may be
expanded without relying on flexible material deformation. Other
suitable means for coupling the branch portions 26a, 26b together
to provide for expansion of the fusion cage 22 are also
contemplated, including forming or coupling of the branch portions
26a, 26b directly to one another without the use of a fixed base
portion 28.
[0035] In the illustrated embodiment of the invention, axial
displacement of the expansion member 24 generally along the
longitudinal axis L between the branch portions 26a, 26b causes the
branch portions 26a, 26b to separate or splay apart, thereby
expanding the fusion cage 22 along the transverse axis T. However,
it should be understood that in other embodiments of the invention,
rotational or pivotal displacement of the expansion member 24
relative to the branches 26a, 26b may cause the fusion cage 22 to
expand. Other types of relative displacement between the expansion
member 24 and the branch portions 26a, 26b are also contemplated
for use in association with the present invention to expand the
fusion cage 22, including, for example, displacement of the
expansion member 24 in directions transverse to the longitudinal
axis L.
[0036] In one embodiment of the invention, the branch portions 26a,
26b of the fusion cage 22 each have a shell-like configuration and
cooperate with one another to define a substantially hollow cage
interior or passage 30 extending generally along the longitudinal
axis L. As illustrated in FIG. 6, the walls of the branch portion
26a, 26b are relatively thin so as to maximize the volume of hollow
interior 30. As will be discussed below, maximizing the volume of
hollow interior 30 will increase the amount of a bone growth
promoting material that may be positioned within the fusion cage 22
to facilitate fusion with the adjacent vertebral bodies.
[0037] As illustrated in FIG. 6, the hollow interior or passage 30
preferably extends entirely through the fusion cage 22 so as to
define a proximal opening 30a adjacent the proximal end 22a and a
distal opening 30b adjacent the distal end 22b. However, it should
be understood that in other embodiments of the invention, the
hollow interior or passage 30 need not necessarily extend entirely
through the fusion cage 22. In another embodiment, the branch
portions 26a, 26b cooperate with one another to define a
substantially cylindrical configuration. However, it should be
understood that other shapes and configurations of the fusion cage
22 are also contemplated as falling within the scope of the present
invention.
[0038] In the illustrated embodiment of the invention, the branch
portions 26a, 26b define a first pair of oppositely-disposed outer
surfaces 32a, 32b having a curved or arcuate configuration, and a
second pair of oppositely-disposed outer surfaces 34a, 34b
extending between the first pair of surfaces 32a, 32b and having a
generally flat or planar configuration. In this embodiment of the
fusion cage 22, the branch portions 26a, 26b cooperate with one
another to define a substantially cylindrical configuration having
truncated side portions. However, it should be understood that
other shapes and configurations of the fusion cage 22 and the
branch portions 26a, 26b are also contemplated as falling within
the scope of the present invention, including, for example, a
non-truncated cylindrical configuration, an elliptical
configuration, a conical configuration, a rectangular
configuration, or any other suitable shape or configuration.
[0039] The first pair of outer surfaces 32a, 32b preferably defines
a number of bone anchoring elements 36 adapted for engagement with
the adjacent vertebral bodies V.sub.U, V.sub.L to prevent or
inhibit movement of the fusion cage 22 once implanted within the
intervertebral disc space D (FIG. 12). In a specific embodiment,
the bone anchoring elements 36 comprise external threads extending
along a substantial portion of the length of the fusion cage 22.
The external threads preferably define a thread pattern that allows
for threading advancement of the fusion cage 22 between the
vertebral bodies V.sub.U, V.sub.L as the fusion cage 22 is rotated
about the longitudinal axis L. The threads also provide secure
anchoring to the adjacent vertebral bodies V.sub.U, V.sub.L
subsequent to insertion into the intervertebral disc space D.
Either or both of outer surfaces 32a, 32b may define a flattened
region or recessed area 38 adjacent the proximal half of the fusion
cage 22 which interrupts the external threads 36. The flattened
region or recessed area 38 is included to provide additional
flexibility to the branch portions 26a, 26b to facilitate expansion
of the fusion cage 22 and/or to provide an external area of
engagement with an instrument or tool.
[0040] Although the bone anchoring elements 36 have been
illustrated and described as comprising external threads, it should
be understood that other types and configurations of bone anchoring
elements are also contemplated for use in association with the
fusion cage 22. For example, various types and configurations of
projections or surface irregularities may be provided which extend
from the first pair of outer surfaces 32a, 32b, including ridges,
teeth, spikes, surface roughening, or any other suitable anchoring
element. Further, although the bone anchoring elements 36 are
illustrated as extending about the fusion cage 22 in a
circumferential direction, in other embodiments of the invention,
the bone anchoring elements 36 may be configured to extend
generally along the length of the fusion cage 22 in an axial
direction. Additionally, it should also understood that in other
embodiments of the invention, the first pair of outer surface 32a,
32b need not necessarily include bone anchoring elements 36, but
may alternatively define a substantially smooth configuration
devoid of any projections or surface irregularities. It should also
be understood that although the second pair of outer surface 34a,
34b of the fusion cage 22 are illustrated as being devoid of any
projections or surface irregularities, in other embodiments of the
invention, the outer surfaces 34a, 34b may also define a number of
bone anchoring elements.
[0041] In the illustrated embodiment of the fusion cage 22, each of
the branch portions 26a and 26b defines at least one bone in-growth
opening or window 40 extending through the outer surfaces 32a and
32b, respectively, and communicating with the hollow cage interior
30. The openings 40 are provided to permit bone growth from the
adjacent vertebral bodies V.sub.U, V.sub.L and into and potentially
through the fusion cage 22. Although the fusion cage 22 is
illustrated as including a single bone in-growth opening 40
extending through each of the outer surfaces 32a, 32b, it should be
understood that in other embodiments, multiple bone in-growth
openings 40 may extend through each of the outer surfaces 32a, 32b
in communication with the hollow interior 30. It should further be
understood that although the openings 40 are illustrated and
described as communicating with the hollow interior 30, in other
embodiments, the openings 40 need not necessarily extend entirely
through the branch portions 26a, 26b.
[0042] As illustrated in FIG. 3, the bone in-growth openings 40
have a slot-like configuration defining a slot length l.sub.S
extending along the overall length l.sub.C of the fusion cage 22,
as measured between the proximal and distal ends 22a, 22b. As also
illustrated in FIG. 3, the bone in-growth openings 40 have a slot
width w.sub.S extending across the overall width w.sub.C of the
fusion cage 22, as measured between the outer surfaces 34a, 34b. In
a specific embodiment of the invention, the slot length l.sub.S
extends along at least about one half of the overall length l.sub.C
of the fusion cage 22. In a further embodiment. the slot width
w.sub.S extends across at least about one half of the overall width
w.sub.C of the fusion cage 22. It should be understood, however,
that other shapes, configurations and sizes of the bone in-growth
openings 40 are also contemplated as falling within the scope of
the present invention.
[0043] In a further embodiment of the invention, a bone growth
promoting material 42 (FIG. 10) may be positioned within the hollow
cage interior 30 to facilitate or promote bone growth through the
openings 40 and into and potentially through the fusion cage 22. In
one embodiment, the bone growth promoting material 42 is loaded
into the hollow interior 30 subsequent to insertion of the fusion
cage 22 into the intervertebral disc space D. However, it should be
understood that the bone growth promoting material 42 may
alternatively be positioned within the hollow interior 30 prior to
insertion of the fusion cage 22 into the intervertebral disc space
D. In another embodiment, the bone growth promoting material 42 is
loaded into the hollow interior 30 via the opening 30a adjacent the
proximal end 22a of the fusion cage 22. However, it should be
understood that the bone growth promoting material 42 may
alternatively be loaded into the hollow interior 30 via the opening
30b adjacent the distal end 22b, or through other openings in the
fusion cage 22, such as, for example, through openings extending
through the flat outer surfaces 34a, 34b or through the bone
in-growth openings 40 extending through the curved outer surfaces
32a, 32b.
[0044] In one embodiment, the bone growth promoting material 42 is
comprised of a bone morphogenic protein (BMP). However, other types
of bone growth promoting materials are also contemplated for use in
association with the present invention, such as, for example, a
bone graft material including autograft bone, bone chips or bone
marrow, a demineralized bone matrix (DBM), mesenchymal stem cells,
a LIM mineralization protein (LMP), or any other suitable bone
growth promoting material or substance that would occur to one of
skill in the art. Additionally, it should be understood that the
bone growth promoting material 42 may be used with or without a
suitable carrier.
[0045] In another embodiment of the invention, the distal end
portion 22b of the fusion cage 22, and more specifically the distal
end portions of the branches 26a, 26b, cooperate to define a
rounded or bullet-shaped leading end portion 44 defining a curved
outer surface 46 configured to facilitate insertion of the fusion
cage 22 into the intervertebral disc space D between adjacent
vertebral bodies V.sub.U, V.sub.L and/or to facilitate distraction
of the adjacent vertebral bodies V.sub.U, V.sub.L. The
bullet-shaped end portion 44 may be particularly useful to
facilitate insertion of the fusion cage 22 into the intervertebral
disc space D via an impaction or push-in technique. However, the
bullet-shaped end portion 44 may also be useful to facilitate
insertion and advancement of the fusion cage 22 between the
adjacent vertebral bodies V.sub.U, V.sub.I via other types of
insertion techniques, such as, for example, a threading technique.
It should be understood that the distal end portion 22b of the
fusion cage 22 may take on other configurations to facilitate
insertion between the adjacent vertebral bodies V.sub.U, V.sub.L,
such as, for example, a conical, tapered or beveled configuration.
It should also be understood that in other embodiments of the
invention, the distal end 22b of the fusion cage 22 may define a
flat or blunt configuration.
[0046] In order to facilitate expansion of the fusion cage 22, the
branches 26a, 26b are separated from one another by a channel or
slot extending longitudinally from the distal end 22b of the fusion
cage 22 toward the proximal end 22a and terminating adjacent the
fixed base portion 28. Specifically, in the illustrated embodiment,
the fusion cage 22 defines a pair of channels or slots 50a and 50b
extending along the flat outer surfaces 34a and 34b, respectively,
and communicating with the hollow cage interior 30. Additionally,
the channels 50a, 50b are positioned substantially opposite one
another so as to define substantially symmetrical branch portions
26a, 26b. However, it should be understood that the channels 50a,
50b may extend along other portions of the fusion cage 22 and may
be alternatively positioned so as to define non-symmetrical branch
portions 26a, 26b.
[0047] In the illustrated embodiment of the invention, the channels
50a, 50b each include a first enlarged portion 52 positioned
adjacent the fixed base portion 28, a relatively narrow slit
portion 54 extending distally from the first enlarged portion 52
toward a second enlarged portion 56, and an inwardly tapering
portion 58 extending distally from the second enlarged portion 56
toward the distal end 22b. Although a specific configuration of the
channels 50a, 50b has been illustrated and described herein, it
should be understood that other suitable channel or slot
configurations are also contemplated as falling within the scope of
the present invention.
[0048] In one embodiment of the invention, the first enlarged
portion 52 has a slot-like configuration defining a slot length
extending generally along the transverse axis T. The enlarged slot
portion 52 tends to increase flexibility at the interconnection
location between the branch portions 26a, 26b and the fixed base
portion 28 so as to facilitate transitioning of the fusion cage 22
to an expanded configuration, while at the same time tending to
decrease stress concentrations which might otherwise develop at the
interconnection location. The enlarged slot portion 52 may also be
used as a means for receiving a corresponding portion of an
instrument or tool to aid in the manipulation and handing of the
spinal implant assembly 20. In one embodiment of the invention, the
second enlarged portion 56 has a generally circular configuration
sized to receive the expansion member 24 therethrough to allow for
lateral insertion of the expansion member 24 into the hollow
interior 30 of the fusion cage 22. The narrow slit portion 54
extending between the first and second enlarged portions 52, 56
reduces the amount of material removed from the side walls of the
branch portions 26a, 26b, thereby enclosing a greater portion of
the hollow interior 30 to more fully contain the bone growth
promoting material 42 within the fusion cage 22.
[0049] As illustrated in FIG. 6, the inwardly tapering portion 58
of each channel 50a, 50b is defined by opposing tapered surfaces
60a, 60b, which are in turn defined by opposing longitudinal edges
of the branch portions 26a, 26b. Additionally, in the illustrated
embodiment of the invention, the opposing tapered surfaces 60a, 60b
are defined by a plurality of opposing pairs of discrete tapered
surfaces 62a, 62b. In one embodiment, the discrete tapered surfaces
62a collectively forming the tapered surface 60a are all sloped in
the same direction, and the discrete tapered surfaces 62b forming
the tapered surface 60b are likewise all sloped in the same
direction. However, axially adjacent ones of the discrete tapered
surfaces 62a are not co-planar, but are instead transversely offset
from one another so as to define a transverse shoulder 64a
therebetween. Similarly, axially adjacent ones of the discrete
tapered surfaces 62b are transversely offset from one another so as
to define a transverse shoulder 64b therebetween, with the
transverse shoulders 64a, 64b arranged in pairs and positioned
generally transversely opposite one another. In this manner, the
opposing pairs of tapered surfaces 62a, 62b and the oppositely
disposed pairs of transverse shoulders 64a, 64b define a number of
opposing pairs of ratchets 66a, 66b positioned along the length of
the tapering portion 58 of each channel 50a, 50b.
[0050] As will be discussed below, the opposing ratchets 66a, 66b
serve as retention elements or interlock features that engage a
corresponding portion of the expansion member 24 to retain or lock
the expansion member 24 in select axial positions relative to the
fusion cage 22. As should be appreciated, engagement between the
expansion member 24 and the opposing ratchets 66a, 66b prevents
movement of the expansion member 24 in a direction opposite the
transverse shoulders 64a, 64b to thereby maintain the fusion cage
22 in an expanded configuration. Additionally, in the illustrated
embodiment of the invention, an opposing pair of grooves or notches
68a, 68b are defined adjacent a corresponding pair of the
transverse shoulders 64a, 64b to further facilitate the retention
or locking of the expansion member 24 in select axial positions
relative to the fusion cage 22.
[0051] Although a specific embodiment of the retention elements or
interlock features has been illustrated and described herein, it
should be understood that other types and configurations of
retention elements or interlock features suitable for retaining or
locking the expansion member 24 in select axial positions relative
to the fusion cage 22 are also contemplated. For example,
embodiments using the ratchets 66a, 66b without the notches 68a,
68b, and embodiments using the notches 68a, 68b without the
ratchets 66a, 66b, are also contemplated. Additionally, in another
embodiment, the branch portions 26a, 26b may define internal
threads adapted to threadingly engage a correspondingly threaded
portion of the expansion member 24. In a further embodiment, the
branch portions 26a, 26b may define a number of surface projections
configured to engage a corresponding portion of the expansion
member 24. In another embodiment, a retention element of interlock
feature may be provided that does not require direct engagement
between the fusion cage 22 and the expansion member 24. It should
also be understood that ratchets 66a, 66b and/or notches 68a, 68b
need not necessarily be defined along each of the tapered surfaces
60a, 60b, but may alternatively be defined along either of the
tapered surfaces 60a, 60b. It should further be understood that in
other embodiments of the invention, the opposing tapered surfaces
60a, 60b need not include retention elements or interlock features,
but may alternatively have a substantially planar or uninterrupted
configuration.
[0052] Referring to FIG. 7, in the illustrated embodiment of the
invention, the expansion member 24 has a wedge-like configuration
including a leading portion 70 and a trailing portion 72.
Additionally, the expansion member 24 has a length le that is
approximately equal to the overall width w.sub.C of the fusion cage
22 (FIG. 3). In this manner, the expansion member 24 is sized to
engage each of the longitudinal edges, and more specifically the
opposing tapered surfaces 60a, 60b of the branch portions 26a, 26b.
As will be discussed below, axial advancement of the expansion
member 24 along the hollow interior 30 of the fusion cage 22, and
more specifically along the opposing tapered surfaces 60a, 60b,
results in transitioning of the fusion cage 22 to an expanded
configuration.
[0053] In the illustrated embodiment of the expansion member 24,
the leading portion 70 includes a curved or tapered surface 74 to
facilitate sliding advancement of the expansion member 24 along the
opposing tapered surfaces 60a, 60b of the branch portions 26a, 26b.
However, it should be understood that other configurations of the
leading portion 70 are also contemplated. The trailing portion 72
of the expansion member 24 preferably includes a pair of opposite
tapered surface 76a, 76b that are angled to substantially
correspond to the taper angle of the opposing tapered surfaces 60a,
60b of the branch portions 26a, 26. The trailing portion 72 also
includes a central opening 78 adapted to engagingly receive a
distal end portion of a driving tool therein to aid in axially
displacing the expansion member 24 through the fusion cage 22. The
opening 78 may be threaded so as to threadingly engage a distal end
portion of a driving tool therein to provide for more secure
engagement between the tool and the expansion member 24.
[0054] As shown in FIG. 10, the trailing portion 72, and more
specifically the tapered surfaces 76a, 76b, bear against the
opposing tapered surfaces 60a, 60b of the branch portions 26a, 26b
when the fusion cage 22 is transitioned to a partially expanded or
fully expanded configuration. Engagement between the tapered
surfaces 76a, 76b of the expansion member 24 and the opposing
tapered surfaces 60a, 60b of the branch portions 26a, 26b aids in
maintaining the fusion cage 22 in a partially expanded or fully
expanded configuration, and also tends to increase the stability of
the fusion cage 22 when transitioned to an expanded configuration.
Additionally, the tapered surfaces 76a, 76b of the trailing portion
72 are preferably inwardly offset relative to the leading portion
70 so as to define a pair of opposite transverse shoulders or
ridges 80a, 80b. The transverse shoulders 80a, 80b in turn define a
pair of opposite pawls 82a, 82b that are configured for engagement
with a corresponding pair of opposing ratchets 66a, 66b defined
along the longitudinal tapered surfaces or edges 60a, 60b of the
branch portions 26a, 26b. Additionally, the trailing end surface of
the expansion member 24 defines a pair of opposite corner portions
or shoulders 84a, 84b which in turn define a second pair of
opposite pawls 86a, 86b that are configured for engagement with a
corresponding pair of opposing ratchets 66a, 66b.
[0055] Although a specific embodiment of the expansion member 24 is
illustrated and described herein, it should be understood that
other suitable configurations of the expansion member 24 are also
contemplated as falling within the scope of the present invention.
For example, the expansion member 24 may be provided with other
elements or features that engage or otherwise cooperate with the
branch portions 26a, 26b so as to retain or lock the expansion
member 24 in select axial positions relative to the fusion cage 22.
For example, as indicated above, the branch portions 26a, 26b may
define internal threads that are adapted to threadingly engage a
correspondingly threaded portion of the expansion member 24.
Additionally, it should be understood that the pawls 82a, 82b and
86a, 86b need not necessarily extend along the entire length le of
the expansion member 24, but may alternatively be defined along the
lateral end portions of the expansion member 24 so as to provide
engagement with the tapered longitudinal edges 60a, 60b of the
branch portions 26a, 26b. It should also be understood that the
expansion member 24 need not necessarily include first and second
pairs of pawls 82a, 82b and 86a, 86b, but may alternatively define
a single pair of pawls.
[0056] Referring to FIGS. 8-10, shown therein are three operational
positions of the expansion member 24 relative to the fusion cage 22
according to one embodiment of the invention. FIG. 8 illustrates a
first operational position wherein the expansion member 24 is
positioned adjacent the enlarged circular portion 56 defined by the
slots 50a, 50b extending along the branch portions 26a, 26b. In
this first operational position, the fusion cage 22 is a maintained
in a non-expanded configuration, with the branch portions 26a, 26b
arranged substantially parallel to one another. As should be
appreciated, the fusion cage 22 may be inserted into the
intervertebral disc space D between the upper and lower vertebrae
V.sub.U, V.sub.L while in the non-expanded configuration via either
a threading technique or a push-in/impaction technique.
[0057] Once inserted into the intervertebral disc space D, the
fusion cage 22 may be selectively transitioned to a partially
expanded configuration, as illustrated in FIG. 9, or to a fully
expanded configuration, as illustrated in FIG. 10. However, it
should be understood that in other embodiments of the invention,
the fusion cage 22 may be selectively transitioned to a partially
or fully expanded configuration prior to being inserted into the
intervertebral disc space D. As should be appreciated, the degree
of expansion of the fusion cage 22 corresponds to the selected
operational position of the expansion member 24 along the
longitudinal axis L which, as discussed above, may be selectively
controlled via engagement of the pairs of pawls 82a, 82b and 86a,
86b with corresponding pairs of the opposing ratchets 66a, 66b. As
will be discussed below, when the fusion cage 22 is transitioned to
a partially or fully expanded configuration, the branch portions
26a, 26b are angled relative to one another so as to define an
outwardly tapered configuration extending from the proximal end 22a
toward the distal end 22b.
[0058] As illustrated in FIGS. 9 and 10, since the movable branch
portions 26a, 26b are integrally connected with one another via the
fixed base portion 28, expansion of the fusion cage 22 is not
uniform along the length l.sub.C of the fusion cage 22. Instead,
the fixed proximal ends of the branch portions 26a, 26b adjacent
the fixed base portion 28 remain relatively stationary, and
therefore do not appreciably expand along the transverse axis T.
However, the movable distal ends of the branch portions 26a, 26b
separate or splay apart to transversely expand the distal end
portion of the fusion cage 22 from an initial height h.sub.1 (FIG.
8) to expanded heights h.sub.2 and h.sub.3 (FIGS. 9 and 10).
[0059] As illustrated in FIGS. 8 and 9, an instrument or tool 90
may be provided to aid in the manipulation and handling of the
spinal implant assembly 20 and to axially displace the expansion
member 24 relative to the fusion cage 22 to facilitate
transitioning of the fusion cage 22 toward an expanded
configuration. In the illustrated embodiment, the instrument 90
generally comprises an outer sleeve 92 and an inner actuator shaft
94. The surgical instrument 90 may also include a handle (not
shown) to further aid in the manipulation and handling of the
spinal implant assembly 20.
[0060] The outer sleeve 92 is engaged with the proximal end portion
22a of the fusion cage 22. In one embodiment, engagement between
the outer sleeve 92 and the fusion cage 22 is abutting engagement.
However, it should be understood that other types of engagement are
also contemplated, such as, for example, threaded engagement, keyed
engagement, tongue-and-groove engagement, frictional engagement, or
any other suitable method of engagement.
[0061] The actuator shaft 94 is disposed within the outer sleeve 92
and includes a distal portion 96 extending through the proximal
opening 30a and into the hollow interior 30 of the fusion cage 22,
with a distal-most end portion 98 engaging the expansion member 24.
In one embodiment of the invention, the distal-most end portion 98
is received within the central opening 78 in the expansion member
24. In the illustrated embodiment, the distal-most end portion 98
has a generally circular outer cross section that closely
corresponds with the inner circular cross section of the opening 78
to provide secure engagement between the actuator shaft 94 and the
expansion member 24. However, other shapes and configurations of
the distal-most end portion 98 are also contemplated for use in
association with the present invention, including rectangular or
hexagonal configurations. Additionally, various types of engagement
between the tool 90 and the expansion member 24 are contemplated,
such as, for example, abutting engagement, threaded engagement,
keyed engagement, tongue-and-groove engagement, frictional
engagement, or any other suitable method of engagement.
[0062] Although a specific embodiment of the instrument 90 has been
illustrated and described herein, it should be understood that
other embodiments of instruments or tools suitable for use in
association with the spinal implant assembly 20 are also
contemplated, and that the features, elements and operation thereof
may differ from those associated with the surgical instrument 90.
One example of another embodiment of an instrument 200 suitable for
use in association with the spinal implant assembly 20 is
illustrated in FIGS. 13-16 and described below. Another example of
a suitable instrument is illustrated and described in U.S. Pat. No.
6,436,140 to Liu et al., the entire contents of which are hereby
incorporated herein by reference.
[0063] As should be appreciated, application of an axial force F
onto the actuator shaft 94 correspondingly displaces the expansion
member 24 relative to the fusion cage 22 generally along the
longitudinal axis L. As the expansion member 24 is axially
displaced through the fusion cage 22, the branch portions 26a, 26b
are separated or splayed apart to transition the fusion cage 22
toward a partially expanded configuration (FIG. 9) or to a fully
expanded configuration (FIG. 10). More specifically, as the leading
portion 70 of the expansion member 24 is slidably engaged along the
inwardly tapering surfaces 60a, 60b of the branch portions 26a,
26b, the expansion member 24 acts as a wedge to drive the branch
portions 26a, 26b apart to thereby expand the fusion cage 22 along
the transverse axis T.
[0064] As should also be appreciated, engagement of the pairs of
pawls 82a, 82b and 86a, 86b with corresponding pairs of the
opposing ratchets 66a, 66b serves to retain the expansion member 24
in a select axial position relative to the fusion cage 22.
Specifically, abutment of the transverse shoulders 80a, 80b of the
pawls 82a, 82b and the corners or edges 84a, 84b of the pawls 86a,
86b against the transverse shoulders 64a, 64b of the corresponding
ratchets 66a, 66b prevents backward movement of the expansion
member 24 in a trailing direction (e.g., toward the fixed base
portion 28). Additionally, a portion of the pawls 82a, 82b and 86a,
86b may be positioned within corresponding opposing pairs of the
notches 68a, 68b to further aid in retaining the expansion member
24 in the select axial position relative to the fusion cage 22.
[0065] As should further be appreciated, the ratchets 66a, 66b and
the pairs of pawls 82a, 82b and 86a, 86b are configured and
arranged so as to allow relatively uninhibited forward movement of
the expansion member 24 in a leading direction (e.g., toward the
distal end 22b) to allow for transitioning of the fusion cage 22
toward an expanded configuration. However, interlocking engagement
between the ratchets 66a, 66b and the pawls 82a, 82b and 86a, 86b
retains the expansion member 24 in a select axial position to
maintain the fusion cage 22 in a partially expanded or fully
expanded configuration. Additionally, since the branch portions
26a, 26b define a series of opposing pairs of ratchets 66a, 66b
disposed at various axial locations along the tapered surfaces 60a,
60b, the fusion cage 22 may be selectively transitioned to
predetermined states or degrees of expansion.
[0066] Selective transitioning of the fusion cage 22 to
predetermined states or degrees of expansion may thereby serve to
more closely match the structural configuration and shape of the
fusion cage 22 to the patient's spinal anatomy. For example,
controlling expansion of the fusion cage 22 also controls the taper
angle between the branch portions 26a, 26b so as to more closely
match the lordotic angle between the upper and lower vertebrae
V.sub.U, V.sub.L. If the fusion cage 22 is inserted into the
intervertebral disc space prior to transitioning to an expanded
configuration, expansion of the fusion cage 22 may also serve to
distract the intervertebral disc space in addition to restoring
and/or maintaining lordosis between the upper and lower vertebrae
V.sub.U, V.sub.L. Following expansion of the fusion cage 22, the
surgical instrument 90 may be disengaged from the spinal implant
assembly 20 and removed from the patient. As discussed above, a
bone growth promoting material 42 (FIG. 10) may be loaded into the
hollow interior 30 of the fusion cage 22 to facilitate or promote
bone growth from the upper and lower vertebrae V.sub.U, V.sub.L,
through the bone in-growth openings 40 and into and possibly
through the fusion cage 22.
[0067] Having illustrated and described the elements and operation
of the spinal implant assembly 20, reference will now be made to a
technique for implanting the spinal implant assembly 20 within an
intervertebral disc space according to one embodiment of the
invention. However, it should be understood that other implantation
techniques and procedures are also contemplated, and that the
following technique in no way limits the scope of the present
invention.
[0068] Referring to FIGS. 11 and 12, the vertebral level to be
treated is initially identified, followed by the removal of at
least a portion of the natural intervertebral disc via a total or
partial discectomy. The endplates of the upper and lower vertebrae
V.sub.U, V.sub.L may then be prepared using known surgical
instruments and techniques (e.g., rotating cutters, curettes,
chisels, etc.). In one embodiment, a tapping instrument may be used
to cut threads along the endplates of the upper and lower vertebrae
V.sub.U, V.sub.L to allow the fusion cage 22 to be threadingly
inserted into the intervertebral disc space D. However, in another
embodiment of the invention, the threads 36 formed along the fusion
cage 22 may be self-tapping threads so as to eliminate the need to
pre-cut threads along the vertebral endplates.
[0069] Following preparation of the intervertebral disc space D and
the upper and lower vertebrae V.sub.U, V.sub.L, the spinal implant
assembly 20 is inserted into the intervertebral disc space D via a
suitable insertion technique, such as, for example, via a threading
technique or by an impaction/push-in type technique. The
bullet-shaped leading end portion 44 of the fusion cage 22
facilitates insertion between the upper and lower vertebrae
V.sub.U, V.sub.L. As discussed above, in one embodiment of the
invention, the spinal implant assembly 20 may be inserted into the
intervertebral disc space D while the fusion cage 22 in a
non-expanded configuration (FIG. 8). However, in some instances it
may be desirable to transition the spinal implant assembly 20 to a
partially expanded or fully expanded configuration (FIGS. 9 and 10)
either before or during insertion into the intervertebral disc
space D.
[0070] Insertion of the spinal implant assembly 20 into the
intervertebral disc space D while in a non-expanded configuration
is particularly applicable when the fusion cage 22 is inserted via
a threading technique so as to minimize neural distraction. In the
non-expanded configuration, the branch portions 26a, 26b are
arranged substantially parallel to one another to provide the
fusion cage 22 with a substantially uniform outer dimension between
the threaded arcuate surfaces 32a, 32b along substantially the
entire length of the fusion cage 22. In a further embodiment of the
invention, the spinal implant assembly 20 may be inserted into the
intervertebral disc space D in a minimally invasive manner (i.e.,
through a small access portal) via the use of endoscopic equipment,
a small diameter tube or cannula, or by other suitable minimally
invasive surgical techniques. Minimally invasive insertion of the
spinal implant assembly 20 into the disc space D is preferably
accomplished with the assembly 20 maintained in a non-expanded
configuration.
[0071] As illustrated in FIGS. 11 and 12, the fusion cage 22 has a
height dimension h.sub.C measured between the threaded outer
surfaces 32a, 32b and a width dimension w.sub.C measured between
the truncated outer surfaces 34a, 34b which is less than the height
dimension h.sub.C. This truncated configuration of the fusion cage
22 allows for insertion into the intervertebral disc space D with
the truncated outer surfaces 34a, 34b arranged generally parallel
to the vertebral endplates of the upper and lower vertebrae
V.sub.U, V.sub.L, and with the width dimension w.sub.C aligned
generally along the axis A of the vertebral column (FIG. 11). The
fusion cage 22 may then be rotated ninety (90) degrees in the
direction of arrow R to engage the threaded outer surfaces 32a, 32b
with the upper and lower vertebral endplates, with the height
dimension h.sub.C aligned generally along the axis A of the
vertebral column (FIG. 12). Engagement of the threads 36 with the
upper and lower vertebral endplates inhibits movement of the fusion
cage 22 relative to the upper and lower vertebrae V.sub.U, V.sub.L,
and also reduces the risk of expulsion of the fusion cage 22 from
the intervertebral disc space D.
[0072] As should be appreciated, the above-described technique for
inserting the spinal implant assembly 20 into the intervertebral
disc space D minimizes distraction of the upper and lower vertebrae
V.sub.U, V.sub.L which likewise reduces neural distraction. As
should also be appreciated, this technique may be particularly
beneficial in instances where the fusion cage 22 is transitioned to
an expanded configuration prior to being inserted into the disc
space D.
[0073] Additionally, removal or revision of the fusion cage 22 can
be easily accomplished by simply rotating the fusion cage 22 ninety
(90) degrees to disengage the threaded surfaces 32a, 32b from the
upper and lower vertebrae V.sub.U, V.sub.L to once again arrange
the truncated outer surfaces 34a, 34b parallel to the vertebral
endplates of the upper and lower vertebrae V.sub.U, V.sub.L. At
this point, the fusion cage 22 can be easily removed from and/or
repositioned within the intervertebral disc space D without
necessarily having to transition the fusion cage 22 back to the
initial non-expanded configuration (FIG. 8).
[0074] Once the spinal implant assembly 20 is inserted into the
intervertebral disc space D and arranged in the orientation
illustrated in FIG. 12, the fusion cage 22 is then transitioned to
a partially expanded or fully expanded configuration (FIGS. 9 and
10). However, as discussed above, in other embodiments of the
invention, the fusion cage 22 may be transitioned to a partially
expanded or fully expanded configuration prior to insertion into
the intervertebral disc space D. As also discussed above, the
fusion cage 22 may be transitioned to an expanded configuration via
axial displacement of the expansion member 24 along the tapered
surfaces 60a, 60b, which in turn causes the branch portions 26a,
26b to separate or splay apart to distract and/or restore/maintain
lordosis between the upper and lower vertebrae V.sub.U, V.sub.L.
Moreover, the degree of expansion of the fusion cage 22 and the
taper angle defined between the branch portions 26a, 26b
corresponds to the axial position of the expansion member 24 which,
as discussed above, may be selectively controlled via engagement of
the pawls 82a, 82b and 86a, 86b with corresponding pairs of the
opposing ratchets 66a, 66b. Accordingly, the degree of expansion
and the taper angle may be selected/adjusted in situ to tailor the
configuration of the fusion cage 22 to the specific spinal anatomy
of the patient being treated.
[0075] Following expansion of the fusion cage 22, a bone growth
promoting material 42 (FIG. 10) may be injected or otherwise loaded
into the hollow interior 30 of the fusion cage 22 to facilitate or
promote bone growth from the upper and lower vertebrae V.sub.U,
V.sub.L, through the bone growth openings 40, and into and possibly
through the fusion cage 22. However, as indicated above, the bone
growth promoting material 42 may be positioned within the hollow
interior 30 prior to or during insertion and/or expansion of the
fusion cage 22. A morselized autograft bone or a similar type of
material may also be positioned adjacent the expanded fusion cage
22 to further promote bony fusion. Additionally, in some instances
it may be desirable to remove a portion of the upper and lower
vertebral endplates to expose cancellous bone into direct contact
with the fusion cage 22 and/or with the bone growth promoting
material 42 disposed therein to further facilitate bony ingrowth
and fusion between the fusion cage 22 and the upper and lower
vertebrae V.sub.U, V.sub.L.
[0076] In one embodiment of the invention, access to the spinal
column and insertion of the spinal implant assembly 20 into the
intervertebral disc space D is accomplished via a posterior
surgical approach. However, it should be understood that access to
and insertion of the spinal implant assembly 20 into the
intervertebral disc space D may be accomplished via other surgical
approaches, such as, for example, an anterior approach or a lateral
approach. In another embodiment of the invention, the spinal
implant assembly 20 is used to treat the lumbar region of the
spine, with the upper and lower vertebrae V.sub.U, V.sub.L
comprising lumbar vertebrae. However, it should nevertheless be
understood that the present invention is also applicable to other
portions of the spine, including the cervical, thoracic or sacral
regions of the spine. Additionally, in a further embodiment of the
invention, a pair of the spinal implant assemblies 20 may be
positioned side-by-side in a bilateral arrangement within the
intervertebral disc space D. However, it should be understood that
unilateral placement or central placement of a single spinal
implant assembly 20 within the intervertebral disc space D is also
contemplated as falling within the scope of the present
invention.
[0077] Referring to FIGS. 13-16, shown therein is an instrument or
tool 200 according to another form of the present invention for use
in association with a spinal implant assembly 300. The spinal
implant assembly 300 is configured similar to the spinal implant
assembly 20 illustrated and described above, generally comprising
an expandable fusion cage 322 and an expansion member 324. In the
illustrated embodiment, the fusion cage 322 includes a pair of
movable branch portions 326a, 326b flexibly interconnected to one
another via a fixed base portion 328 such that axial displacement
of the expansion member 324 between the branch portions 326a, 326b
causes the branch portions 326a, 326b to separate or splay
apart.
[0078] Additionally, the branch portions 326a, 326b cooperate with
one another to define a substantially hollow cage interior 330
which preferably extends entirely through the fusion cage 322 so as
to define an open proximal end and an open distal end. The fusion
cage 322 includes a pair of arcuate outer surfaces 332a and 332b
formed along the branch portions 326a, 326b, each defining external
threads 336. A bone in-growth opening 340 extends through each of
the arcuate outer surfaces 332a, 332b in communication with the
hollow cage interior 330. The branches 326a, 326b are separated
from one another by a channel defining opposing tapered surfaces
360a, 360b, which in turn define a number of opposing pairs of
ratchets 366a, 366b. The pairs of ratchets 366a, 366b cooperate
with opposite pawls 382a, 382b and 386a, 386b defined by the
expansion member 324 to retain or lock the expansion member 324 in
a select axial position relative to the fusion cage 322.
[0079] The instrument 200 is adapted to selectively engage the
spinal implant assembly 300 to aid in the manipulation and handling
thereof and to axially displace the expansion member 324 relative
to the fusion cage 322 to facilitate transitioning of the fusion
cage 322 toward an expanded configuration. In the illustrated
embodiment, the instrument 200 extends along a longitudinal axis L
and is generally comprised of an outer sleeve member 202, an inner
actuator member 204, a handle member 206 disposed adjacent a
proximal end portion 200a of the instrument, and an engagement
mechanism 208 disposed adjacent a distal end portion 200b of the
instrument.
[0080] In the illustrated embodiment of the instrument 200, the
sleeve member 202 includes an axial passage 210 extending
therethrough, and the actuator member 204 includes a shaft portion
212 and a proximal portion 214. The shaft portion 212 is sized and
shaped to extend through the axial passage 210 in the sleeve member
202. In one embodiment, the axial passage 210 and the shaft portion
212 each have a generally circular configuration; however, other
suitable shapes and configurations are also contemplated. The
proximal portion 214 of the actuator member 204 defines external
threads 216 and a tool receiving opening 218. The handle member 206
is engaged with a proximal end portion of the outer sleeve 202 and
defines an internally threaded axial passage 220 adapted to
threadingly receive the threaded proximal portion 214 of the
actuator member 204 therein.
[0081] In the illustrated embodiment, the handle member 206
comprises an outer gripping portion 222 and an insert portion 224.
The gripping portion 222 defines an axial passageway 226 sized and
shaped to receive the insert portion 224 therein. The insert
portion 224 defines the threaded axial passage 220 and includes a
knob portion 228 extending from the proximal end of the gripping
portion 222. The insert portion 224 is rotatable within the axial
passageway 226 via application of a rotational force onto the knob
portion 228, which in turn results in threading engagement of the
threaded proximal portion 214 of the actuator member 204 along the
threaded axial passage 220 to correspondingly displace the actuator
shaft portion 212 along the longitudinal axis L. However, in
another embodiment of the invention, the handle member 206 may be
configured as a single piece structure (e.g., with no separate
insert portion 226). In this manner, application of a rotational
force onto a driver instrument (not shown) having a shaped distal
end portion positioned within the tool receiving opening 218 in the
threaded proximal portion 214 of the actuator member 204 drives the
threaded proximal portion 214 along the axial threaded passage 220
to correspondingly displace the actuator shaft 212 along the
longitudinal axis L.
[0082] In the illustrated embodiment of the instrument 200, the
engagement mechanism 208 is adapted to selectively engage and
disengage the spinal implant assembly 300. In one embodiment of the
invention, the engagement mechanism 208 comprises a pair of
oppositely disposed engagement arms 230a, 230b. In another
embodiment, the engagement arms 230a, 230b are pivotally coupled to
a distal portion of the sleeve member 202 in such a manner as to
allow pivotal movement of the engagement arms 230a, 230b between a
retracted/disengaged configuration (FIG. 14) and an
expanded/engaged configuration (FIG. 15), the details of which will
be discussed below. In a further embodiment, the engagement arms
230a, 230b are pivotally coupled to the sleeve member 202 to allow
pivotal movement about pivot axes P.sub.1 and P.sub.2,
respectively, with the pivot axes P.sub.1, P.sub.2 being offset and
arranged substantially parallel to one another.
[0083] In the illustrated embodiment of the invention, the
engagement arms 230a, 230b include axial portions 232a, 232b and
transverse flange portions or bosses 234a, 234b. The axial portions
232a, 232b are at least partially disposed within and extend
generally along the axial passage 210 in the sleeve member 202 and
are pivotally coupled to the sleeve member 202 via a hinge pins
236a, 236b. The transverse flange portions 234a, 234b are
positioned outside the axial passage 210 adjacent the distal end of
the sleeve member 202 and extend in generally opposite transverse
directions. In one embodiment of the invention, the engagement arms
230a, 230b are biased such that the transverse flange portions
234a, 234b are urged toward one another in such a manner as to
provide the retracted configuration illustrated in FIG. 14. Biasing
of the engagement arms 230a, 230b toward the retracted
configuration can be provided via a number of methods. For example,
in one embodiment, one or more springs (not shown) engaged between
the sleeve member 202 and the engagement arms 230a, 230b can be
used to bias the engagement arms 230a, 230b toward the retracted
configuration. However, other configurations and embodiments for
biasing the engagement arms 230a, 230b toward the retracted
configuration are also contemplated.
[0084] Referring to FIG. 14, the instrument 200 is shown in a
retracted configuration wherein the engagement arms 230a, 230b are
inwardly biased toward one another such that the transverse flange
portions 234a, 234b are positioned adjacent one another to define a
reduced transverse profile. The retracted transverse flange
portions 234a, 234b are inserted through the open proximal end of
the fusion cage 300 and into the hollow cage interior 330, with the
distal end of the sleeve member 202 positioned adjacent the
proximal end of the fusion cage 300 and with the transverse flange
portions 234a, 234b positioned adjacent the bone in-growth openings
340. The shaft portion 212 of the actuator member 204 is then
axially advanced through the outer sleeve 202 in the direction of
arrow A via application of a rotational force onto the knob portion
228 of the handle member 206 (FIG. 13). As should be appreciated,
axial advancement of the shaft portion 212 in turn displaces the
distal end of the shaft 212 between the engagement arms 230a, 230b
which results in outward pivotal movement of the engagement arms
230a, 230b in the direction of arrows B.
[0085] Referring to FIG. 15, continued axial advancement of the
shaft portion 212 in the direction of arrow A transitions the
engagement arms 230a, 230b to an expanded/engaged configuration.
Specifically, axial advancement of the shaft portion 212 between
the engagement arms 230a, 230b outwardly pivots the engagement arms
230a, 230b away from one another in the direction of arrows B which
in turn outwardly displaces the transverse flange portions 234a,
234b into engagement within the bone in-growth openings 340 in the
fusion cage 300 to selectively and securely engage the instrument
200 with the fusion cage 300. However, it should be understood that
the transverse flange portions 234a, 234b need not necessarily be
positioned within the bone in-growth openings 340 to provide
selective and secure engagement between the instrument 200 and the
fusion cage 300, but may instead be positioned within other
apertures or openings defined by the fusion cage 300 and/or engaged
with other portions of the fusion cage 300.
[0086] Referring to FIG. 16, continued axial advancement of the
shaft portion 212 in the direction of arrow A results in engagement
of the distal end of the shaft portion 212 against the expansion
member 324, which correspondingly axially advances the expansion
member 324 along the hollow interior 330 to transition the fusion
cage 300 to an expanded configuration. Specifically, as the
expansion member 324 is axially displaced through the hollow
interior 330, the branch portions 326a, 326b are separated or
splayed apart via sliding engagement between the expansion member
324 and the opposing tapered surfaces 360a, 360b, thereby resulting
in expansion of the fusion cage 322 generally along the transverse
axis T. As discussed above with regard to the fusion cage 22, the
opposite pawls 382a, 382b and 386a, 386b defined by the expansion
member 324 engage corresponding pairs of the opposing ratchets
366a, 366b to retain or lock the expansion member 324 in a select
axial position relative to the fusion cage 322, thereby maintaining
the fusion cage 322 in a partially or fully expanded
configuration.
[0087] Once the fusion cage 322 is transitioned to an expanded
configuration, the shaft portion 212 of the actuator member 204 is
retracted from fusion cage 322 via application of a rotational
forces onto the knob portion 228 of the handle member 206 (FIG.
13). As should be appreciated, since the engagement arms 230a, 230b
are inwardly biased toward one another, removal of the shaft
portion 212 from between the engagement arms 230a, 230b results in
inward pivotal back toward the retracted configuration illustrated
in FIG. 14. Inward pivotal movement of the engagement arms 230a,
230b in turn inwardly displaces the transverse flange portions
234a, 234b and disengages the flange portions 234a, 234b from the
bone in-growth openings 340, thereby allowing for selective
disengagement of the instrument 200 from the fusion cage 300 and
removal of the instrument 200 from the surgical site.
[0088] While the invention has been illustrated and described in
detail in the drawings and foregoing description, the same is to be
considered as illustrative and not restrictive in character, it
being understood that only the preferred embodiments have been
shown and described and that all changes and modifications that
come within the spirit of the invention are desired to be
protected.
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