U.S. patent application number 15/938183 was filed with the patent office on 2018-08-02 for interbody fusion implant and related methods.
This patent application is currently assigned to NuVasive, Inc.. The applicant listed for this patent is NuVasive, Inc.. Invention is credited to Mohammad Etminan, Andrew Morris.
Application Number | 20180214279 15/938183 |
Document ID | / |
Family ID | 48792297 |
Filed Date | 2018-08-02 |
United States Patent
Application |
20180214279 |
Kind Code |
A1 |
Etminan; Mohammad ; et
al. |
August 2, 2018 |
INTERBODY FUSION IMPLANT AND RELATED METHODS
Abstract
An implant for performing interbody fusion within a human spine,
inserters for such an implant, and associated methodology. The
implant is preferably formed in situ from at least two separate but
lockable members (a base member and a closure member). The base
member may be implanted into an interbody space first, after which
the end plates may be finally prepared and the base member packed
with fusion promoting substances before engaging and locking the
closure member. The closure member provides structural support for
the adjacent vertebral bodies (along with the base member) and may
be selected after implantation of the base member having a specific
length, width, height, taper, etc. . . . to ensure an optimal
sizing of the implant for desired restoration of disc height,
coronal taper, sagittal taper, etc. . . .
Inventors: |
Etminan; Mohammad; (Houston,
TX) ; Morris; Andrew; (San Diego, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
NuVasive, Inc. |
San Diego |
CA |
US |
|
|
Assignee: |
NuVasive, Inc.
San Diego
CA
|
Family ID: |
48792297 |
Appl. No.: |
15/938183 |
Filed: |
March 28, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15181241 |
Jun 13, 2016 |
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15938183 |
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13949174 |
Jul 23, 2013 |
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15181241 |
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12834855 |
Jul 12, 2010 |
8491658 |
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13949174 |
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61224887 |
Jul 12, 2009 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2/442 20130101;
A61F 2002/30507 20130101; A61F 2/4611 20130101; A61F 2002/30622
20130101; A61F 2002/30828 20130101; A61F 2002/30779 20130101; A61F
2002/30616 20130101; A61F 2002/3008 20130101; A61F 2002/30299
20130101; A61F 2250/006 20130101; A61F 2002/30904 20130101; A61F
2230/0082 20130101; A61F 2002/30265 20130101; A61F 2002/30429
20130101; A61F 2002/30492 20130101; A61F 2002/30604 20130101; A61F
2002/2817 20130101; A61F 2002/30593 20130101; A61F 2002/4629
20130101; A61F 2002/30471 20130101; A61F 2002/2835 20130101; A61F
2002/30467 20130101; A61F 2/4455 20130101; A61F 2002/30825
20130101; A61F 2/447 20130101; A61F 2002/30266 20130101; A61F
2002/30607 20130101; A61F 2002/30777 20130101; A61F 2002/305
20130101; A61F 2002/30176 20130101; A61F 2002/30774 20130101; A61F
2002/4687 20130101; A61F 2002/30331 20130101; A61F 2002/30481
20130101 |
International
Class: |
A61F 2/44 20060101
A61F002/44 |
Claims
1. An interbody fusion implant for use in lateral access spinal
surgery, comprising: a base member having a side walls and an end
wall defining an open trailing end and an interior bounded by the
side walls and end walls, at least a portion of the end wall
dimensioned to serve as a structural support between cortical bone
regions of adjacent vertebral bodies in the lumbar or thoracic
spine, and the side walls and end wall dimensioned to serve as a
protective barrier between the interior and adjacent neural
structure and/or vasculature; and a closure member dimensioned to
be coupled to the base member to enclose the interior after the
base member has been positioned in a preliminarily prepared disc
space in between said vertebral bodies and end plate preparation
has taken place within the interior of the base member, the closure
member being dimensioned such that at least a portion of the
closure member provides structural support between cortical bone
regions of adjacent vertebral bodies.
2. A system for performing lateral interbody fusion, comprising: a
base member having a side walls and an end wall defining an open
trailing end and an interior bounded by the side walls and end
walls, at least a portion of the end wall dimensioned to serve as a
structural support between cortical bone regions of adjacent
vertebral bodies in the lumbar or thoracic spine, and the side
walls and end wall dimensioned to serve as a protective barrier
between the interior and adjacent neural structure and/or
vasculature; a closure member dimensioned to be coupled to the base
member to enclose the interior after the base member has been
positioned in a preliminarily prepared disc space in between said
vertebral bodies and final end plate preparation has taken place
within the interior of the base member, the closure member being
dimensioned such that at least a portion of the closure member
provides structural support between cortical bone regions of
adjacent vertebral bodies; a base member inserter for inserting the
base member into the preliminarily prepared disc space, the base
member inserter including a body region dimensioned to extend into
the interior of the base member to provide structural support for
the base member during introduction; and a closure member inserter
for inserting the closure member into engagement with the base
member after the final endplate preparation has taken place within
the interior of the base member and after fusion promoting material
has been introduced into the interior of the base member.
3. The system of claim 2, comprising a delivery system for
delivering the fusion promoting material into the interior of the
base member after the final endplate preparation has occurred and
before the closure member has been engaged with the base
member.
4. The system of claim 2, wherein the closure member includes a
locking mechanism for locking the closure member to the base
member.
5. The interbody fusion implant of claim 1, wherein the closure
member is coupled to the base member via at least one locking
member.
6. The interbody fusion implant of claim 5, wherein the at least
one locking member comprises a locking pin dimensioned to extend at
least partially within the closure member and at least partially
within the base member.
7. The interbody fusion implant of claim 6, wherein the locking pin
is rigidly disposed within a proximal end of the base member and
releasably disposed within a recess formed within the closure
member.
8. The interbody fusion implant of claim 7, wherein the closure
member includes a secondary locking mechanism.
9. The interbody fusion implant of claim 8, wherein the secondary
locking mechanism includes an actuating element and at least one
secondary locking element in communication with the recess.
10. The interbody fusion implant of claim 9, wherein the secondary
locking element is a transverse pin member configured to be driven
by the actuating element into locking engagement with the locking
pin.
11. The interbody fusion implant of claim 10, wherein the actuating
element includes a generally tapered distal end which drives the
transverse pin member into contact with the locking pin as the
actuating element is rotatably advanced towards a distal end of the
closure member.
12. The interbody fusion implant of claim 11, wherein the locking
pin has serrations formed along at least a portion of an exterior
surface which facilitate engagement between the locking pin and the
transverse pin member.
13. The interbody fusion implant of claim 5, wherein the at least
one locking member extends from the closure member for engagement
with the base member.
14. The interbody fusion implant of claim 13, wherein the locking
member comprises a hook member dimensioned to engage with a recess
formed in the base member.
23. The interbody fusion implant of claim 14, wherein the closure
member includes an actuating element dimensioned to be selectively
driven into contact with the hook member.
15. The interbody fusion implant of claim 15, wherein the actuating
element is rotatably driven into contact with the hook member by an
instrument.
16. The interbody fusion implant of claim 16, wherein rotation of
the actuating member forces the hook member into engagement within
the recess and thereafter prevents the hook member from
disengagement with the recess.
17. The interbody fusion implant of claim 5, wherein the closure
member includes a distal end having an angled portion, and wherein
the base member includes a proximal end having an angled portion
for mating engagement with the angled portion of the closure
member.
18. The interbody fusion implant of 18, wherein the angled portion
of the closure member includes a groove and wherein the angled
portion of the base member includes a tab dimensioned to be
received within the groove of the angled portion of the closure
member.
19. The interbody fusion implant of claim 18, wherein the at least
one locking member extends from the closure member for engagement
with the base member.
20. The interbody fusion implant of claim 19, wherein the locking
member comprises a hook member dimensioned to engage with a recess
formed in the base member.
Description
DISCUSSION OF THE PRIOR ART
[0001] The human spinal column is made up of a series of vertebral
bodies with intervertebral discs disposed there between, which
collectively provide support and structure for the body while
allowing motion and flexibility, as well as protection for the
spinal cord running through the spinal column and associated nerve
roots which exit the spinal column. Various traumatic events and/or
degenerative conditions may result in undesirable motion or change
in disc height, both of which may cause chronic pain for the
affected individual. The degree and treatment of pain varies by the
individual but in many instances the pain can be disabling and
uncontrollable by conservative means, leaving surgery as the only
viable option. In many cases, the primary surgical treatment
involves interbody fusion, wherein an implant is introduced into
the disc space to restore the disc height and establish a bony
bridge between the adjacent vertebral bodies with the goal of
eliminating or at least reducing the pain of the affected
individual.
[0002] To enable the introduction of an interbody fusion implant,
the surgeon must perform the following steps to create a suitable
environment for post-operative fusion: (a) surgical access to the
affected disc space; (b) an annulotomy to gain access into the
interior of the affected disc; (c) an initial or preliminary
discectomy to remove some or all of the nucleus pulposus within the
affected disc; and (d) final endplate preparation to remove the
cartilaginous disc material to expose the underlying bony endplates
of the adjacent vertebral bodies (preferably without violating the
bony endplates). Final endplate preparation is a critical step in
implant placement and achieving a solid fusion. It is required to
remove all the cartilaginous disc material while not violating the
bony end plate. Not removing the cartilaginous end plate can result
in a delayed bony growth or incomplete bony growth, while
fracturing the bony end plate can result in a fracture of the
vertebral body and post-operative settling of the implant with
concomitant loss of disc height and/or vertebral body alignment.
Repetitive insertion of instruments into the disc space during the
process of final endplate preparation can result in possible injury
to the neural and vascular structures surrounding the disc space if
the instruments are inadvertently passed or extended outside the
disc space by the surgeon.
[0003] To help facilitate fusion, the implants preferably include
one or more "fusion windows," that is, apertures extending from the
superior surface to the inferior surface of the implant to allow
bone to form through the implant to ensure a solid and robust
fusion. To further facilitate fusion, these apertures may be filled
with fusion promoting materials including but not limited to
cancellous autograft bone, allograft bone, demineralized bone
matrix (DBM), porous synthetic bone graft substitute, bone
morphogenic protein (BMP), mesenchymal stem cells and/or
combinations thereof and/or functional equivalents. Such materials
are traditionally introduced into the implant before the implant is
introduction into the disc space. Based on the oftentimes high
amount of force required to be applied to the corresponding
insertion tools, such fusion promoting substances can become
loosened or dislodged during the introduction of the implant, which
can in certain instances increase the amount of time required to
achieve fusion.
[0004] Implants can be introduced into the interbody space in one
of several known approaches or directions to the spine, including
posterior (from the back), anterior (from the front), and lateral
(from the side). Before 2003, interbody fusion via a lateral
approach was uncommon because of the inability to safely pass
through the psoas muscle, which flanks either side of the lumbar
spine and includes the lumbar plexus. Lateral access surgery became
safe and reproducible with the advent of the NeuroVision.RTM.
system by NuVasive, Inc., which automatically detects the presence
of nerves in the psoas muscle via surgeon-directed neurophysiology
in combination with minimally disruptive access instrumentation
(e.g. dilators, retractor, etc. . . . ) to aid the surgeon in
avoiding nerves while establishing an operative corridor from a
lateral approach.
[0005] The present invention addresses the need for additional
interbody implant options, inserters, and techniques for use in
lateral access surgery.
SUMMARY OF THE INVENTION
[0006] The present invention involves a novel interbody fusion
implant for use in lateral access surgery, inserters for said
implant, and associated methodology. The interbody fusion implant
has two separate but lockable members (a base member and a closure
member). According to an aspect of the present invention, the base
member and closure member are complimentary to each other so that
they can be engaged and thereafter locked together while in a
lumbar or thoracic interbody space. The base member is configured
in a generally elongated U-shaped manner with generally parallel
side walls coupled to an end wall positioned generally
perpendicularly with the side walls. The base member and closure
member may be equipped with any number of suitable locking features
to lock the closure member to the base member.
[0007] According to an aspect of the present invention, the base
member is introduced into the interbody space before the closure
member. By doing so, and given the U-shaped configuration of the
base member, this allows for an aggressive final end plate
preparation, inspection of the final position of base member within
the disc space, and packing of fusion promoting material after the
base member is implanted but before the closure member is
implanted. This presents a host of benefits, which will be
described in detail below, along with the specific method steps
associated with the use of the base member and closure member
during lateral access surgery according to an aspect of the present
invention. The introduction of the base member is facilitated
through the use of a specialized inserter designed to bolster the
structural integrity of the base member during insertion to reduce
the likelihood of having the base member fracture under the
impaction forces typically involved in interbody fusion procedures.
The introduction of the base member is also facilitated via the
tapered leading end, which serves as a general wedge between the
adjacent vertebral bodies during insertion of the base member into
the disc space during impaction.
[0008] After the fusion promoting material is introduced into the
base member, the closure member can be engaged and locked to the
base member according to an aspect of the present invention. In
general, however, this manner of constructing the implant in situ
within the interbody space offers a host of additional features
beyond those of traditional interbody implants of unibody
construction. It offers an enhanced safety profile based on the
protection offered by the base member during final endplate
preparation, which forms a barrier such that the associated
instruments for final endplate preparation cannot be inadvertently
passed or extended outside the disc space by the surgeon and into
contact with the adjacent neural and vascular structures. It offers
increased efficiency in final endplate preparation by limiting the
area of final endplate preparation to just that area within the
interior of the base member. It also advantageously separates the
weight bearing portion of the base member (i.e. the upper and lower
contact surfaces) from the potential fusion area created within the
interior of the base member, thereby allowing for an aggressive
removal of the cartilaginous endplates within interior of the base
member (e.g. extending into the cancellous bone to cause ample
bleeding to promote the fusion process).
[0009] In situ formation of the implant of the present invention
also prevents or reduces the risk of subsidence of the implant into
the softer cancellous bone in two distinct manners. First, it does
so by not requiring the cartilaginous endplates to be removed prior
to implant introduction as is required with traditional implants.
In other words, this allows the cartilaginous endplates to provide
protection against fracturing the underlying vertebral body during
the introduction of the base member, which can occur during the
implantation of traditional interbody implants of unibody
construction if the surgeon is not careful to avoid. It also
prevents or reduces subsidence by allowing the length of the
closure member to be selected after the implantation of the base
member to maximize the surface area of the overall implant to
ensure leading and trailing ends of the result implant are
positioned on the stronger cortical bone forming the ring apophysis
around the periphery of the vertebral bodies. In this regard, both
the base member and the closure member are in direct contact with
upper and lower vertebral bodies, thereby bearing weight and
sharing the associated loads. The height of the closure member can
also be determined after the implantation of the base member and
may be different from the height of the base member, allowing for
possible correction of a coronal deformity in the interbody
space.
[0010] Finally, in situ implant formation also advantageously
allows a surgeon to aggressively pack the fusion promoting material
into the implant more than may be capable with conventional
implants of unibody construction. This is because the surgeon need
only pack the fusion promoting material into the base member after
implantation, as opposed to impacting an implant that has been
packed with fusion promoting material before implantation and
dislodge or loosen the fusion promoting material as is the case
with traditional implants.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] FIG. 1 is a perspective exploded view of an interbody fusion
implant including a base member and a closure member according to
an aspect of the present invention;
[0012] FIG. 2 is a cross sectional view of a patient during lateral
access surgery with the base member of FIG. 1 in the interbody
space (with final endplate preparation having been performed after
the implantation of the base member) according to aspects of the
present invention;
[0013] FIG. 3 is a cross sectional view of a patient during lateral
access surgery with the closure member of FIG. 1 attached to the
base member of FIG. 1 (with fusion promoting material disposed
therein, having been introduced after the implantation of the base
member but before the implantation of the closure member) according
to aspects of the present invention;
[0014] FIG. 4 is a top exploded view of the interbody fusion
implant of FIG. 1 according to an aspect of the present
invention;
[0015] FIG. 5 is a top exploded view, in partial cross section, of
the interbody fusion implant of FIG. 1 illustrating the locking
features between the base and closure members before engagement and
locking of the closure member to the base member according to an
aspect of the present invention;
[0016] FIG. 6 is a top view, in partial cross section, of the
interbody fusion implant of FIG. 1 illustrating the locking
features between the base and closure members after engagement and
locking according to an aspect of the present invention;
[0017] FIG. 7 is a perspective view of an inserter for use with the
base member of the interbody fusion implant of FIG. 1 according to
an aspect of the present invention;
[0018] FIGS. 8 and 9 are perspective views of the inserter of FIG.
7 and the base member of FIG. 1 before and after, respectively,
coupling together according to an aspect of the present
invention;
[0019] FIG. 10 is a perspective view of an inserter for use with
the closure member of the interbody fusion implant of FIG. 1
according to an aspect of the present invention;
[0020] FIG. 11 is a perspective enlarged view of the distal end of
the inserter of FIG. 10 according to an aspect of the present
invention;
[0021] FIGS. 12 and 13 are perspective views of the inserter of
FIG. 10 and the closure member of FIG. 1 before and after,
respectively, coupling together according to an aspect of the
present invention;
[0022] FIG. 14 is a top view of a patient in the lateral decubitus
position in preparation for lateral access surgery;
[0023] FIG. 15 is a posterior view of a patient in the lateral
decubitus position in preparation for lateral access surgery
illustrating aspects and general positioning of the lumbar and
thoracic spine;
[0024] FIG. 16 is a side view of a prior art retractor system
positioned laterally relative to the patient's lumbar spine in
preparation for the implantation of the interbody fusion implant of
FIG. 1 according to an aspect of the present invention;
[0025] FIG. 17 is a lateral view down an operative corridor
established by the prior art retractor system of FIG. 16 before an
annulotomy and discectomy are performed in preparation for the
implantation of the interbody fusion implant of FIG. 1 according to
an aspect of the present invention;
[0026] FIG. 18 is a cross sectional view of a patient during
lateral access surgery after an annulotomy and preliminary
discectomy have been performed in preparation for the implantation
of the interbody fusion implant of FIG. 1 according to an aspect of
the present invention;
[0027] FIG. 19 is a cross sectional view of a patient during
lateral access surgery illustrating the optional step of
sizing/distracting the disc space before introducing the base
member of FIG. 1 according to an aspect of the present
invention;
[0028] FIG. 20 is a cross sectional view of a patient during
lateral access surgery illustrating the step of introducing the
base member of FIG. 1 with the associated inserter of FIG. 7
according to an aspect of the present invention;
[0029] FIG. 21(a) is a cross sectional view of a patient during
lateral access surgery illustrating the step of final end plate
preparation after the introduction of the base member of FIG. 1,
but before the introduction of the closure member of FIG. 1,
according to an aspect of the present invention;
[0030] FIG. 21(b) is an enlarged view of the trailing end of the
base member after final endplate preparation according to an aspect
of the present invention;
[0031] FIG. 22 is a cross sectional view of a patient during
lateral access surgery illustrating the step of introducing fusion
promoting material into the finally prepared disc space within the
base member of FIG. 1 according to an aspect of the present
invention;
[0032] FIG. 23 is a cross sectional view of a patient during
lateral access surgery illustrating the step of introducing the
closure member of FIG. 1 for the engagement with the base member of
FIG. 1 according to an aspect of the present invention;
[0033] FIG. 24 is a flow chart describing the method steps involved
in implanting an interbody fusion implant according to an aspect of
the present invention;
[0034] FIG. 25 is a perspective exploded view of an interbody
fusion implant including a base member and closure member according
to another aspect of the present invention; FIG. 26 is a top
exploded view of the base member and closure member of FIG. 24
before engagement and locking together according to an aspect of
the present invention;
[0035] FIG. 27 is a top view of the base member and closure member
of FIG. 24 after engagement and during the process of locking
together according to an aspect of the present invention;
[0036] FIG. 28 is a side view of interbody fusion implant of FIG.
24 after locking the closure member to the base member according to
an aspect of the present invention;
[0037] FIG. 29 is an end view of the closure member of FIG. 24
illustrating the engagement features for coupling the closure
member to an inserter as well as the locking screw element for
locking the closure member to the base member according to an
aspect of the present invention;
[0038] FIG. 30 is a perspective exploded view of an interbody
fusion implant including a base member and a closure member
according to yet another aspect of the present invention;
[0039] FIG. 31 is a top exploded view of the interbody fusion
implant of FIG. 30 according to an aspect of the present
invention;
[0040] FIG. 32 is a perspective view of the closure member of FIG.
30 according to an aspect of the present invention;
[0041] FIG. 33 is a perspective exploded view of an interbody
fusion implant including a base member and a closure member
according to a still further aspect of the present invention;
[0042] FIGS. 34 and 35 are top and end views, respectively, of the
base member of FIG. 33 illustrating slot features for coupling the
closure member to the base member according to an aspect of the
present invention;
[0043] FIG. 36 is a side view of one arm of the base member of FIG.
33 further illustrating the slot features for engaging the closure
member to the base member, as well as a recess for receiving
locking prongs of the closure member of FIG. 33 according to an
aspect of the present invention;
[0044] FIG. 37 is a perspective view of the closure member of FIG.
33 according to an aspect of the present invention; and
[0045] FIGS. 38 and 39 are perspective views of an inserter for use
with the base member of FIGS. 25-29 before and after, respectively,
coupling together according to an aspect of the present
invention.
DESCRIPTION OF THE PREFERRED EMBODIMENT
[0046] Illustrative embodiments of the invention are described
below. In the interest of clarity, not all features of an actual
implementation are described in this specification. It will of
course be appreciated that in the development of any such actual
embodiment, numerous implementation-specific decisions must be made
to achieve the developer's specific goals, such as compliance with
system-related and business-related constraints, which will vary
from one implementation to another. Moreover, it will be
appreciated that such a development effort might be complex and
time-consuming, but would nevertheless be a routine undertaking for
those of ordinary skill in the art having the benefit of this
disclosure. The interbody implant, inserters, and associated
methodology for spinal fusion using a lateral approach to the spine
disclosed herein boasts a variety of inventive features and
components that warrant patent protection, both individually and in
combination.
[0047] FIG. 1 is a perspective exploded view of an interbody fusion
implant 10 including a base member 12 and a closure member 14
according to an aspect of the present invention. The base member 12
and closure member 14 are complimentary to each other so that they
can be engaged and thereafter locked together while in a lumbar or
thoracic intervertebral (aka interbody) space. The base member 12
is configured in a generally elongated U-shaped manner with
generally parallel side walls 16 coupled to an end wall 18
positioned generally perpendicularly with the side walls 16. The
base member 12 includes, by way of example only, locking features
in the form of locking pins 20 extending longitudinally away from
the trailing ends of the side walls 16. The closure member 14
includes a main body 22 with complimentary locking features in the
form of recesses 24 to receive the locking pins 20 of the base
member 12 and extensions 26 extending generally longitudinally away
from the main body 22 towards the base member 12. The mechanics and
operation of this exemplary locking mechanism will be described in
greater detail below.
[0048] With reference to FIGS. 2 and 3, according to an aspect of
the present invention, the base member 12 is introduced into the
interbody space before the closure member 14. By doing so, and
given the U-shaped configuration of the base member 12, this allows
for inspection of the base member 12 to ensure optimal positioning
before final endplate preparation, an aggressive final vertebral
end plate preparation to create a fully prepared fusion area 13
with the base member 12, and packing of fusion promoting materia115
into the fusion area 13 after the base member 12 has been implanted
but before the closure member 14 is implanted (FIG. 2). This
presents a host of benefits, which will be described in detail
below, along with the specific method steps associated with the use
of the base member 12 and closure member 14 during lateral access
surgery according to an aspect of the present invention. The
introduction of the base member 12 is facilitated through the use
of a specialized inserter (not shown, but described below) designed
to bolster the structural integrity of the base member 12 during
insertion to reduce the likelihood of having the base member 12
fracture under the impaction forces typically involved in interbody
fusion cases. The introduction of the base member 12 is also
facilitated via the slightly tapered leading end 28, which serves
as a general wedge between the adjacent vertebral bodies during
insertion of the base member 12 into the disc space during
impaction.
[0049] After the fusion promoting material is introduced into the
base member 12, the closure member 14 can be engaged and locked to
the base member 12 as shown generally in FIG. 3 and as will be
described in greater detail below. In general, however, this manner
of constructing implant 10 in situ within the interbody space is
advantageous in that it allows a surgeon to aggressively and
efficiently prepare the bony endplates that will serve for a fusion
bed within the base member 12 while the sides of the base member
16, and 18 protect the surrounding neurovascular structures (such
as the vena cava VC, aorta A and posterior neural structures NS) as
well as the weight bearing portions of the vertebral end plates.
The design also allows the surgeon to aggressively pack fusion
promoting material into the implant 10 more than may be capable
with conventional, unitary designs. In addition, the length of the
closure member 14 may be selected after the implantation of the
based member 12 to maximize the surface area of the over implant 10
to ensure the leading and trailing ends of the implant 10 are
positioned on the stronger cortical ring apophysis of the vertebral
bodies, thereby minimizing the risk of subsidence into the softer
cancellous region. In this regard, both the base member 12 and the
closure member 14 are in direct contact with upper and lower
vertebral end plates, thereby bearing weight and sharing the loads
from the end plates. The height of the closure member 14 can also
be determined after the implantation of the base member 12
(differing from the height and/or curvature of the base member 12)
allowing for possible of correction of coronal deformity within the
disc space or adjacent vertebral bodies.
[0050] With reference to FIGS. 4-5, by way of example only,
according to an aspect of the present invention the base member 12
includes locking pins 20 and the closure member 14 includes
recesses 24. The closure member 14 has two tabs 26 extending
outward in the opposite direction of the recesses 24. The tabs 26
align the closure member 14 with the base member 12 when the
closure member 14 is being attached to the base member 12 in the
interbody space. Both the base member 12 and the closure member 14
include a series of anti-migration features 32 on the upper and
lower surfaces 34, 36 to help prevent migration of the implant
relative to the adjacent vertebral bodies while in the interbody
space. Although shown as angled teeth, the anti-migration features
32 may be configured and arranged in any number of suitable manners
and structures sufficient to prevent or minimize the propensity for
the implant 10 to migrate or move after implantation.
[0051] As shown in FIG. 5, the locking pins 20 of the base member
12 are (by way of example only) separate components that are
affixed to the base member 12 prior to the installation of the base
member 12 into the interbody space. By using separate pieces for
the locking pins 20, the locking pins 20 can be of the same or
different material than that of the base member 12. In one aspect,
the locking pins 20 may be of a metallic construction to
simultaneously serve as radiopaque markers to aid in the
visualization of the base member 12 or implant 10 during and/or
after implantation, particularly when the base member 12 and
closure member 14 are constructed of radiolucent material, such as
poly-ether-ether-ketone (PEEK) and/or other suitable biocompatible
and radiolucent materials. Although shown as separate components in
FIG. 5, the base member 12 and locking pins 20 may be constructed
in a unitary fashion without departing from the scope of the
invention. Similarly, the locking features shown and described with
reference to FIG. 5 could be reversed, with the locking pins 20
extending from the closure member 14 and the tabs 26 extending from
the base member 12, without departing from the scope of the
invention.
[0052] In either event, the recesses 24 of the closure member 14
are preferably complimentary to the shape of the locking pins 20 of
the base member 12 to facilitate the engagement of the closure
member 14 to the base member 12 during use. Depending upon the
tolerance between the recesses 24 and the locking pins 20, the
sheer act of advancing the locking pins 20 within the recesses 24
may serve as the primary (and possibly only) manner of locking the
closure member 14 to the base member 12 via a resulting friction
fit. To facilitate this, locking pins 20 may include a variety of
serrations 38 to help engage the interior of the recesses 24. if
desired, the recesses 24 and locking pins 20 may be dimensioned to
allow for some clearance between the serrations 38 of the locking
pins 20 and the interior of the recesses 24.
[0053] As best shown in FIGS. 5-6, a secondary locking mechanism
may also be provided according to an aspect of the present
invention, such as (by way of example only) equipping the closure
member 14 with an actuating element 40 and a pair of transverse
pins 42. The actuating element 40 is disposed within a longitudinal
recess 44 extending (by way of example only) along the longitudinal
axis of the implant 10. The transverse pins 42 are disposed within
corresponding transverse apertures 46 extending (by way of example
only) generally perpendicularly from the longitudinal recess 44. As
best shown in FIG. 5, prior to actuation (i.e. axial translation
towards the interior of the implant 10), a trailing end 48 of the
actuation element 40 extends slightly past the longitudinal recess
44 and a beveled leading end 50 is barely (if at all) in contact
with the medial ends of the transverse pins 42.
[0054] As best shown in FIG. 6, upon actuation, the trailing end 48
is moved axially within the longitudinal recess 44 such that the
beveled leading end 50 forces the transverse pins 42 into axial
translation within the transverse apertures 46 and into physical
engagement with the locking pins 20 of the base member 12 which are
disposed within the recesses 24 of the closure member 14. This
action serves to form a secondary lock between the closure member
14 and the base member 12. The actuation element 40 may be any
number of different mechanisms for driving the transverse pins 42
into the locked position against the locking pins 20, including but
not limited to a set screw type component as shown in FIGS. 5-6.
The serrations 38 of the locking pins 20 advantageously aid in
establishing purchase with the pointed end of the transverse pins
42 to thereby augment the locking ability between the closure
member 14 and base member 12. The serrations 38 may also be angled
as shown in FIG. 6 in order to make them easier to insert within
the recesses 24 than to remove from the recesses 24. The transverse
pins 42 may be of a metallic construction to simultaneously serve
as radiopaque markers to aid in the visualization of the closure
member 14 or the implant 10 during and/or after implantation,
particularly when the base member 12 and closure member 14 are
constructed of radiolucent material, such as polyether-ether-ketone
(PEEK) and/or other suitable biocompatible and radiolucent
materials.
[0055] The actuation element 40 as described above provides a
number of benefits, including allowing a final inspection of the
base member 12 and closure member 14 before the actuation element
40 is advanced to the locking position shown in FIG. 6. As such, if
the sizing or the position of the implant 10 is determined to be
less than optimal or for whatever reason undesirable by the
surgeon, they have the option of simply removing the closure member
14 without first needing to back out the actuation element 40 and
disengage the transverse pins 42 from the locking pins 20. Another
benefit is that, by positioning the actuation element 40 within the
longitudinal aperture 44 of the closure member 14 during the
introduction of the closure member, it prevents any bodily tissues
from building up or becoming lodged in the longitudinal aperture
44. A still further benefit is that, once the fully assembled
implant 10 is packed with fusion promoting material 52 (as
illustrated in FIG. 3), the fusion promoting material does not have
an aperture to allow for an egress route through the closure member
14.
[0056] According to an aspect of the present invention, the base
members 12 and closure members 14 shown herein may be introduced
into an interbody space via any number of suitable insertion
instruments. By way of example only, FIGS. 7-9 illustrate an
inserter 60 for use in introducing the base member 12 of FIGS. 1-6
into an interbody space according to an aspect of the present
invention. As best viewed in FIG. 7, the inserter 60 includes an
elongated shaft 62 with a handle region 64 and an insertion region
66 disposed at either end. The elongated shaft 62 is hollow in
construction and houses a coaxially aligned inner shaft having a
threaded distal end 68 and a proximal end coupled to a thumb wheel
70 located in the handle region 64. The insertion region 66
includes a main body 72 and lateral members 74 extending generally
laterally from the trailing end at the approximate junction with
the elongated shaft 62. The main body 72 has a peripheral shape
that is generally complimentary to the interior shape of the base
member 12 as defined by the side walls 16 and end wal118. The
lateral members 74 are dimensioned to abut the trailing ends 76 of
the side walls 16 when the main body 72 is positioned within the
base member 12. The lateral members 74 have each have a recess 30
extending generally longitudinally within the lateral members 74
dimensioned to accommodate and receive the locking pins 20 of the
base member 12 to facilitate engagement between the base member 12
and inserter 60. The threaded distal end 68 extends beyond the
leading end 78 of the main body 72.
[0057] As best viewed in FIGS. 8-9, by rotating the thumb wheel 70,
the threaded distal end 68 can be selectively engaged and
disengaged with the corresponding threaded aperture 80 formed in
the end wal118 of the base member 12. More specifically, advancing
the thread 68 into to base member 12 causes the base member 12 to
be pulled towards the main body 72 of the inserter 60 until the
inner surface 82 of the base member 12 is fully mated with the
peripheral surface 84 of the inserter 60 as shown in FIG. 9. The
advancement of the base member 12 toward the main body 72 of the
inserter also results in the advancement of the locking pin 20 in
the recesses 30 of the lateral member 74, thereby providing
rotational stability during insertion into the patient. Once fully
seated in this manner, the base member 12 is ready to be inserted
into the interbody space according to an aspect of the present
invention. After implantation, as will be described in greater
detail below, the inserter 60 can be selectively disengaged from
the base member 12 by reversing the direction the thumb wheel 70
and thus disengaging the threaded distal end 68 from the
corresponding recess 80. This movement will also withdraw the
locking pin 20 form the recesses 30 of the lateral members 74.
[0058] According to an aspect of the present invention, the
complimentary shape of the insertion region 66 relative to the base
member 12 bolsters the structural integrity of the base member 12
during the process of implantation. More specifically, the
elongated and open nature of the generally U-shaped base member 12
causes it to be relatively weak in terms of resisting sheer forces
that may otherwise occur if the base member 12 were introduced by
applying forces to one or both of the trailing ends 76 of the side
walls 16 or only the end wall 18. Instead, the insertion region 66
is dimensioned to maximize the surface area between the main body
72 and the interior of the base member 12.
[0059] FIGS. 10-13 illustrate an inserter 90 for the closure member
14 of FIGS. 1-6 according to an aspect of the present invention. As
shown in FIGS. 10-11, the inserter 90 includes an elongated shaft
92 with a handle region 94 and an insertion region 96 disposed at
either end. The elongated shaft 92 is hollow in construction and
houses a coaxially aligned inner shaft 98 having a proximal end
coupled to a knurled member 100 of the handle region 94 and a pair
of distal ends 102 separated by a gap 104 extending a predetermined
distance within the distal end 106 of the hollow elongated shaft
92. The inner shaft 98 also includes a pair of arm members 108,
with each arm member 108 having a prong member 110 extending
longitudinally away from a distal surface 112. The inner shaft 98
is also generally hollow in construction and houses a driver member
114 (by way of example only, a hex driver) having a proximal end
extending beyond the handle region 94 and a distal end extending
beyond the arm members 108 of the inner shaft 98.
[0060] In addition to the knurled element 100, the handle region 94
also includes a counter-torque element 116 coupled to the proximal
end 118 of the elongated shaft 92. The counter-torque element 116
allows the surgeon to hold the elongated shaft 92 relatively
stationary as the knurled member 100 is rotated relative to the
elongated shaft 92 or vice versa. Although not shown, the interior
of the proximal end 118 of the elongated shaft 92 has a threaded
configuration which cooperates with a threaded configuration
located on the inner shaft 98 adjacent to the knurled member 100.
By rotating the inner shaft 98 relative to the elongated outer
shaft 92, the insertion region 96 will be translated axially
towards the distal end of the elongated shaft 92. This, in turn,
will cause the arm members 108 to be moved towards one another,
thereby reducing the gap 104.
[0061] As best viewed in FIGS. 12-13, to couple the inserter 90 to
the closure member 14, the inserter 90 is advanced such that the
prong members 110 on the arm members 108 extend into the recesses
24 for the locking pins 20 (see FIG. 5). At that point, with the
closure member 14 in abutment with the distal surface 112 of the
arm members 108, the knurled member 100 may be rotated relative to
the counter-torque element 116 (or vice versa) such that the arm
members 108 are forced towards one another and thereby exert a
compression force between the prong members 110 which acts upon the
closure member 14 via the recesses 24 to temporarily lock the
closure member 14 to the inserter 90. Once fully seated in this
manner, the closure member 14 is ready to be inserted into the
interbody space according to an aspect of the present invention,
namely, to engage and then lock with the base member 12. After
implantation, as will be described in greater detail below, the
inserter 90 can be selectively disengaged from the closure member
14 by reversing the direction the knurled member 100 relative to
the anti-torque element 116 and thus disengaging the prongs 110
from the corresponding recesses 24. Before doing so, however, the
driver member 114 may be optionally employed to drive the actuation
element 40 of the closure member 14 as described above in order to
selectively deploy the transverse pins 42 with the goal of
providing a secondary locking between the closure member 14 and the
base member 12. The driver 114 is shown, by way of example only,
with a hexagonal shape rod 120 dimensioned to engage with the
proximal end of the actuation element 40 to engage and/or disengage
the locking mechanism.
[0062] The inserter 90 thus provides the dual advantages of
providing both a mechanism to affix the inserter 90 to the closure
member 14 as well as the ability to engage and operate the
actuation element 40 to lock the closure member 14 to the base
member 12. That said, it will be appreciated that the inserter 90
can be used for the purpose of inserting the closure member 14 into
the disc space without having the ability to lock the closure
member 14 to the base member 12, such as where the secondary
locking features (e.g. transverse pins 42 and actuation element 40)
are not required. Although shown and described in this specific
manner, it will be appreciated that the closure member 14 may be
coupled to the inserter 90 in any number of suitable manners,
including but not limited to the same or similar mechanism as used
in FIG. 9, namely, a threaded rod that threads into a corresponding
threaded hole. It is also contemplated to construct the closure
member 14 to include two different sized threaded holes, one for
the actuation element 40 and one for an additional threaded rod 68
as described above.
[0063] The methodology associated with using the implant 10 during
lateral access surgery according to an aspect of the present
invention will now be described with reference to FIGS. 14-23, as
well as the flow chart in FIG. 24. The first step involves gaining
lateral access to the patient's lumbar or thoracic spine (step 130
in FIG. 24). This is performed by first (FIGS. 14-15) positioning
the patient in the lateral decubitus position and then (FIGS.
16-17) establishing a lateral operative corridor 122 via the
introduction of an access system such as the prior art retractor
124 shown by way of example only. With the operative corridor 122
established, an annulotomy and preliminary discectomy (steps 132,
134 in FIG. 24) must then be performed with the goal of creating an
implant region 17 as shown in FIG. 18 capable of receiving a fully
assembled implant 10 according to an aspect of the present
invention. The implant region 17 preferably extends from the
ipsilateral cortical bone region 19 to the contralateral cortical
bone region 21 and the intervening cancellous bone region 23 of the
underlying vertebral body. (Although shown fully removed on the
contralateral bone region 21 in the interest of clarity, the
annulus in that area may simply be "released" (cut but not fully
removed) in order to accommodate at least a portion of the leading
end of the base member 12.)
[0064] The next step (136 in FIG. 24) involves the process of
sizing the base member 12 to ensure the desired restoration of disc
height, sagittal and coronal balance, etc. . . . This can be
facilitated by (FIG. 19) using a sizer/distractor instrument 128
for the purpose of identifying the proper amount of disc height
restoration as well as loosening up the joint to facilitate the
introduction of the base member 12. Depending upon the pathology
and anatomy, the base member 12 may be selected having any of a
variety of suitable heights, lengths, widths, lordotic tapers,
coronal tapers, etc. . . . Based on the ability to select an
optimally sized closure member 14 after the fusion promoting
material has been packed into the base member 12, it may be
possible to have base members 12 of relatively standard or uniform
length (albeit with varying height, width and curvature dimensions)
in order to minimize the inventory required for surgery, as well as
reduce the amount of time required for selecting a base member 12.
The key is that the leading end of the base member 12 be positioned
at least partially on the contralateral cortical region 21, as will
be discussed in greater detail below.
[0065] Once the desired size of the base member 12 is determined
(optimal or standard), the base member 12 may be inserted into the
interbody space (step 138 in FIG. 24). This is accomplished by
coupling the base member 12 to the inserter 60 and impacting it
into the implant region 17 as shown in FIG. 20 via the use of any
number of well known impaction tools (not shown). The base member
12 should be preferably located within the disc space (more
specifically, within the implant region 17 shown in FIGS. 18-19)
such that the leading end (end wall 18) is positioned at least
partially on the contralateral cortical bone region 21 as shown in
FIG. 20. With the base member 12 positioned in this manner, the
inserter 60 may then be disconnected and the inserter 60 removed
such that the base member 12 is the only element disposed in the
disc space.
[0066] FIGS. 21(a) illustrates the next step (140 in FIG. 24) of
final endplate preparation, which may be accomplished via any
number of well known endplate preparation tools, including but not
limited to scraper 129 shown in FIG. 21(a), to create the fusion
region 13 within the interior of the base member 12 and extending
to the ipsilateral cortical bone region 19. In the interest of
added clarity, FIG. 21(b) illustrates the trailing end of the base
member 12 (and the surrounding area) after final endplate
preparation to further detail the relation of the resulting fusion
region 13 to the previously prepared implant region 17. According
to an aspect of the present invention, the fusion area 13 is an
exact, reproducible region separated from the neurovascular
structures (aorta A, vena cava VC and posterior neural structures
NS) by virtue of the side walls 16 and end wall 18 of the base
member 12, thereby providing an added level of safety against the
inadvertent positioning of the endplate preparation instruments
past or outside the disc space during endplate preparation. Due to
the protective feature of the base member 12, as well as the fact
the upper and lower surfaces of the base member 12 rest upon the
cartilaginous endplate exposed after the preliminary discectomy,
the surgeon may be more aggressive in removing the cartilaginous
endplates, intentionally scraping into the underlying cancellous
bone to ensure sufficient bleeding for the fusion process to occur
in a robust and timely manner.
[0067] With the base member 12 in position and the endplates fully
prepared for fusion, the surgeon may (step 142 in FIG. 24)
introduce and optionally pack any of a variety of fusion promoting
materials within the base member 12 via (by way of example only) a
packing funnel 131 such as shown generally in FIG. 22. Fusion
promoting materials may include, but are not necessarily limited
to, cancellous autograft bone, allograft bone, demineralized bone
matrix (DBM), porous synthetic bone graft substitute, bone
morphogenic protein (BMP), mesenchymal stem cells and/or
combinations thereof and/or functional equivalents. Introducing
this material after the base member 12 has been implanted is
advantageous in that it increases the likelihood that the density
of the fusion promoting material will be greater than if loaded and
packed before introduction into the interbody space. This is
because, with traditional implants which are packed prior to
implantation, the impaction process tends to dislodge or loosen the
fusion promoting substance. By packing the base member 12 after
implantation, the surgeon can pack this material as densely as they
can/wish before enclosing the cavity with the closure member 14
during lateral access surgery according to an aspect of the present
invention.
[0068] Before enclosing the base member 12, the closure member 14
should preferably be sized (step 144 in FIG. 24) to ensure the
optimal length, height, taper, etc. . . . for the desired amount of
disc height restoration as well as (optionally) the preferred
degree of sagittal and/or coronal re-alignment of the adjacent
vertebral bodies. This can be facilitated by any number of suitable
sizing tools (not shown), as well as via radiographic methods (e.g.
MRI, X-ray, fluoroscope, etc. . . . ) and even any of a variety of
depth gauges (not shown). The end goal is determine the optimal
size to ensure that the resulting implant 10, after being formed in
situ in the disc space, is positioned such that at least a portion
of the leading end (end wall 18 of base member 12) and at least a
portion of the trailing end (body 22 of the closure member 14) are
positioned on the contralateral cortical bone region 21 and
ipsilateral cortical bone region 19, respectively, as shown in FIG.
3 and partially in FIG. 23. This minimizes the risk of subsidence
into the softer cancellous region. In this regard, both the base
member 12 and the closure member 14 are in direct contact with
upper and lower vertebral end plates, thereby bearing weight and
sharing the loads from the end plates. Depending upon the pathology
and anatomy, the closure member 14 may be selected having any of a
variety of suitable heights, lengths, widths, lordotic tapers,
coronal tapers, etc. . . . including those different from the base
member 12 in order to (by way of example only) tailor the degree of
lordosis (in the lumbar spine), kyphosis (in the thoracic spine)
and/or coronal realignment (in the lumbar or thoracic spine) after
the base member 12 has been implanted.
[0069] Once the optimal size of the closure member 14 has been
determined, the closure member 14 may be inserted into the
interbody space (step 146 in FIG. 24). This is accomplished by
coupling the closure member 14 to the inserter 90 as shown and
described above with reference to FIGS. 12-13 and then impacting it
into the interbody space 126 and locking it to the base member 12
as shown and described with reference to FIGS. 5-6. FIG. 3
illustrates the end result, with the implant 10 formed in situ with
the interbody space extending laterally with at least a portion of
the leading end (end wall 18 of base member 12) resting on the
contralateral cortical bone region 21 and at least a portion of the
trailing end (body 22 of the closure member 14) resting on the
ipsilateral cortical bone region 19. With the implant 10 filled
with fusion promoting material 15 and enclosed via the combination
of the closure member 14 and the base member 12, the retractor 124
may be removed and the wound closed (step 148 in FIG. 24) as is
well known in the art.
[0070] Having described in detail the specifics of one type of
implant 10 according to an aspect of the present invention, as well
as the associated insertion instruments 60, 90 and methodology in
lateral access surgery, a variety of additional implants forming
aspects of the present invention will now be described. Based on
many of the common features and/or functionality with the implant
10 described above, the following description and the associated
drawings will not include specific references to associated
inserters or much (if any) added detail regarding the associated
methodology, as such is deemed duplicative and unnecessary.
[0071] FIGS. 25-29 illustrate an interbody fusion implant 150
including a base member 12 and closure member 14 according to
another aspect of the present invention. The implant 150 is
virtually identical to the implant 10 of FIGS. 1-23 except that the
closure member 14 and base member 12 have a different locking
mechanism. In particular, the closure member 14 includes a pair of
bendable hook elements 152 extending towards the base member 12,
and the side walls 16 of the base member 12 each include a recess
154 to receive the hook elements 152 after they have been forced
into lateral movement by the axial advancement of the actuator
element 40 of the closure member 14. The trailing end of the
closure member 14 may be configured with any suitable engagement
features for coupling to a suitable inserter, such as the slotted
arrangement shown in FIG. 29 with the actuation element 40 disposed
in the approximate midline. All other features in common with the
implant 10 of FIGS. 1-23 are denoted with the same reference
numbers and an explanation of then functionality may be ascertained
with reference to the discussion of those similar features with
reference to FIGS. 1-23.
[0072] FIGS. 30-32 illustrate an interbody fusion implant 160
including a base member 12 and a closure member 14 according to yet
another aspect of the present invention. The base member 12 has a
rigid, elongated structure rectangular in nature. The base member
12 includes a supplemental wall 162 near the end wal118 that
defines a proximal opening 164 and a distal opening 166. The distal
opening 166 may receive fusion promoting materials before the
introduction of the base member 12, while the proximal opening 164
is dimensioned to receive fusion promoting materials after
implantation of the base member 12 but before enclosure by the
closure member 14. The closure member 14 includes two locking pins
168 extending longitudinally towards the base member 12, and the
base member 12 includes two corresponding recesses 169 to receive
the locking pins 168 for purposes of locking the closure member 14
to the base member 12. As best viewed in FIG. 32, the locking pins
168 have a generally "mushroom" shape with angled elements 167 that
bend in order to permit the locking pin 168 to easily pass through
the recesses 169 and then rebound and flare out to prevent the
disengagement of the closure member 14 from the base member 12.
[0073] FIGS. 33-37 illustrate an interbody fusion implant 170
including a base member 12 and a closure member 14 according to a
still further aspect of the present invention. The base member 12
has a generally U-shape with elongated slots 172 extending along
the interior of the side walls 16 from the proximal end 76 to a
point a predetermined distance towards the end wall 18. The side
walls 16 also each include a recess 174 extending through the side
wal116 to intersect with the elongated slots 172. The closure
member 14 includes a pair of elongated hooks 176 extending towards
the base member 12. The elongated hooks 176 are generally compliant
and bendable such that they will engage within the elongated slots
172 and deform slightly towards one another upon the application of
axial force against the closure member 14 towards the base member
12. The distal region 178 of the hooks will pass along the slots
172 until they reach the recesses 174, at which point they will
automatically rebound and move away from one another to force the
distal regions 178 into the recesses 174 to lock the closure member
14 to the base member 12.
[0074] The closure member 14 also includes a wedge element 177
extending towards the base member 177 according to an aspect of the
present invention. The wedge shape 177 allows for ease of insertion
of the closure member 14 into the interbody space once the base
member 12 has already been installed. The wedge shape 177 is an
additional shape to the closure member 14, and once installed
together with the base member 12, both the top and bottom surfaces
34, 36 are to be in direct contact with the end plates. The
contacting surfaces 34, 36 allow the implant, both the closure
member 14 and the base member 12, to the support weight and to
share the loads from the endplates.
[0075] According to an aspect of the present invention, the
implants described herein can be adapted for different applications
and patient pathologies by selectively varying the heights, widths,
lengths, lordotic taper and coronal taper in any suitable increment
(e.g. 1-2 mm increments for L,W, Hand 1-2 degrees for tapers). By
way of example only, the implants of the present invention may be
provided in lengths ranging from 35-65 mm, heights ranging from
6-18 mm, width ranging from 18-30 mm, lordotic tapers ranging from
0-12 degrees, and coronal tapers ranging from 0-15 degrees. The
individual base members and closure member may also be sized in any
number of suitable manners, including: (a) for base members,
lengths ranging from 30-50 mm, heights ranging from 6-18 mm, widths
ranging from 18-30 mm, lordotic tapers ranging from 0-12 degrees,
and coronal tapers ranging from 0-15 degrees, and (b) for the
closure members, lengths ranging from 5-25 mm, heights ranging from
6-18 mm, widths ranging from 18-30 mm, lordotic tapers ranging from
0-12 degrees, and coronal tapers ranging from 0-15 degrees.
[0076] As noted above, any number of inserters can be used to
implant the base members 12 and closure members 14 disclosed herein
according to an aspect of the present invention, including those
designs illustrated in FIGS. 25-37. This is evidenced, by way of
example only, with reference to FIGS. 41-42, which show the distal
end of an inserter 200 for use with the base member 12 of FIGS.
25-29. The inserter 200 is of the same general construction and
configuration as the inserter 60 of FIGS. 7-9, except that the
lateral members 74 of the insertion region 66 are dimensioned in a
generally acutely angled manner to abut the generally angled
trailing ends 76 of the side walls 16 when the main body 72 is
positioned within the base member 12. In this manner, the insertion
region 66 retains the trailing ends 76 of the side walls 16 by
causing the trailing ends 7 6 to be disposed within the acute angle
formed by the lateral members 74, thereby preventing any unwanted
splay during introduction. Other than this distinction, the
inserter 200 operates in the same manner as the inserter 60 such
that the description need not be repeated.
[0077] Having described a multitude of aspects of the present
invention, including aspects of the interbody fusion implant, the
inserters for each member of the interbody fusion implant, and
associated methodology, it should be understood that this invention
is not limited to only those aspects described above and that
changes and modifications may be made without departing from the
true spirit and scope of the invention as defined in the appended
claims.
* * * * *