U.S. patent application number 17/302451 was filed with the patent office on 2021-08-19 for support device and method for use.
This patent application is currently assigned to Flexmedex, LLC. The applicant listed for this patent is Flexmedex, LLC. Invention is credited to E. Skott Greenhalgh, John-Paul Romano.
Application Number | 20210251772 17/302451 |
Document ID | / |
Family ID | 1000005555301 |
Filed Date | 2021-08-19 |
United States Patent
Application |
20210251772 |
Kind Code |
A1 |
Greenhalgh; E. Skott ; et
al. |
August 19, 2021 |
SUPPORT DEVICE AND METHOD FOR USE
Abstract
Devices and methods for orthopedic support are disclosed. The
device can have a first rigid section hingedly attached to a second
rigid section. The device can be curved or rotated around
obstructions along an access path to a target site. The device can
be delivered to an intervertebral location in a patient.
Inventors: |
Greenhalgh; E. Skott;
(Gladwyne, PA) ; Romano; John-Paul; (Chalfont,
PA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Flexmedex, LLC |
Quakertown |
PA |
US |
|
|
Assignee: |
Flexmedex, LLC
Quakertown
PA
|
Family ID: |
1000005555301 |
Appl. No.: |
17/302451 |
Filed: |
May 3, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16103727 |
Aug 14, 2018 |
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17302451 |
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14874150 |
Oct 2, 2015 |
10070968 |
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16103727 |
|
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13773100 |
Feb 21, 2013 |
|
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14874150 |
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PCT/US2011/048992 |
Aug 24, 2011 |
|
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13773100 |
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61376626 |
Aug 24, 2010 |
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61526630 |
Aug 23, 2011 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2/4405 20130101;
A61F 2002/4415 20130101; A61F 2310/00155 20130101; A61F 2310/0097
20130101; A61F 2/4611 20130101; A61F 2310/00137 20130101; A61F
2002/2835 20130101; A61F 2002/30528 20130101; A61F 2310/00131
20130101; A61F 2310/00952 20130101; A61F 2/442 20130101; A61F
2002/3054 20130101; A61F 2002/30594 20130101; A61F 2310/00023
20130101; A61F 2/4425 20130101; A61F 2002/2817 20130101; A61F
2002/4677 20130101; A61F 2310/00958 20130101; A61F 2002/30685
20130101; A61F 2310/00071 20130101; A61F 2002/30914 20130101; A61F
2310/00592 20130101; A61F 2002/4485 20130101; A61F 2002/3093
20130101; A61F 2310/00017 20130101; A61F 2002/30617 20130101; A61F
2310/00976 20130101; A61F 2002/30538 20130101; A61F 2310/00029
20130101; A61F 2002/30624 20130101; A61F 2002/30785 20130101; A61F
2002/30915 20130101; A61F 2310/00928 20130101; A61F 2310/00796
20130101; A61F 2002/30462 20130101; A61F 2002/4495 20130101; A61F
2002/30378 20130101; A61F 2/4455 20130101; A61F 2002/30593
20130101; A61F 2002/30428 20130101; A61F 2310/00101 20130101; A61F
2310/00083 20130101; A61F 2/30767 20130101; A61F 2002/30471
20130101 |
International
Class: |
A61F 2/44 20060101
A61F002/44; A61F 2/46 20060101 A61F002/46 |
Claims
1. A method for inserting a support device to a target site in a
spine adjacent a first vertebra comprising: creating a channel
through a non-vertebral bone and a vertebra, wherein the creating
of a channel through the vertebra comprises creating a channel
through a vertebral end plate, and wherein creating the channel
comprises drilling with a flexible drill, and wherein the
non-vertebral bone comprises a pelvis; and inserting the support
device through the channel and into the target site, wherein
inserting the support device through the channel and into the
target site comprises: inserting a first rigid section of the
support device through the channel and into the target site,
inserting a second rigid section of the support device through the
channel, rotating the second rigid section of the support device
with respect to the first rigid section, wherein the first rigid
section is hingedly attached to the second rigid section; and
inserting the second rigid section of the support device into the
target site.
2. The method of claim 1, wherein the non-vertebral bone comprises
an ilium.
3. The method of claim 1, wherein the non-vertebral bone comprises
a sacrum.
4. The method of claim 1, further comprising inserting a steering
tube through the channel.
5. The method of claim 1, wherein the first rigid section has gaps,
wherein the second rigid section has teeth, and wherein inserting
the support device through the channel and into the target site
comprises sliding the teeth through the gaps.
6. The method of claim 1, wherein the first rigid section has first
teeth, wherein the second rigid section has second teeth, and
wherein inserting the support device through the channel and into
the target site comprises sliding the first teeth by the second
teeth.
7. The method of claim 1, wherein the first rigid section has first
teeth and gaps between the first teeth, wherein the second rigid
section has second teeth, and wherein inserting the support device
through the channel and into the target site comprises moving the
second teeth through the gaps.
8. The method of claim 1, wherein the first rigid section has first
teeth and first gaps between the first teeth, wherein the second
rigid section has second teeth and second gaps between the second
teeth, and wherein inserting the support device through the channel
and into the target site comprises moving the first teeth through
the second gaps and moving the second teeth through the first
gaps.
9. The method of claim 1, wherein the first rigid section has a
first tooth, a second tooth, and a gap between the first tooth and
the second tooth, wherein the second rigid section has a third
tooth, and wherein inserting the support device through the channel
and into the target site comprises moving the third tooth through
the gap.
10. The method of claim 1, wherein the first rigid section has a
first tooth, a second tooth, and a first gap between the first
tooth and the second tooth, wherein the second rigid section has a
third tooth, a fourth tooth, and a second gap between the third
tooth and the fourth tooth, and wherein inserting the support
device through the channel and into the target site comprises
moving the first tooth through the second gap and moving the third
tooth through the first gap.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 16/103,727 filed Aug. 14, 2018, which is a
continuation of U.S. patent application Ser. No. 14/874,150 filed
Oct. 2, 2015 (now U.S. Pat. No. 10,070,968), which is a
continuation of U.S. patent application Ser. No. 13/773,100 filed
Feb. 21, 2013 (now abandoned), which is a continuation of PCT
Application No. PCT/US2011/048992 filed Aug. 24, 2011, which claims
priority to U.S. Provisional Patent Application No. 61/376,626
filed Aug. 24, 2010 and to U.S. Provisional Patent Application No.
61/526,630 filed Aug. 23, 2011, all of which are incorporated by
reference herein in their entireties for all purposes.
BACKGROUND OF THE INVENTION
1. Field of the Invention
[0002] A device, such as a flexible spinal fusion cage, which can
articulate (bend) in such a way that it will be able to be
implanted from a lateral approach into L4-L5 and L5-S1 is
disclosed.
2. Description of the Related Art
[0003] Typical lateral approach fusion implants (e.g., Discover
XLIF, by NuVasive, Inc., San Diego, Calif.; and the Direct Lateral
Interbody Fusion (DLIF) by Medtronic, Inc., Minneapolis, Minn.) are
not able to implant their fusion cages for two reasons.
[0004] First, boney obstacles can impair access. FIGS. 1a and 1b
illustrate the pelvis and lower spine including the Ilium 2, sacrum
S1, and lower lumbar vertebrae L3, L4 and L5. FIGS. 1a and 1b show
the challenge of gaining lateral access to the L4-L5 and the L5-S1
intervertebral spaces. The position of the Ilium 2 obstructs the
direct lateral access pathway.
[0005] FIG. 2 illustrates windows 4a and 4b or channels which some
doctors create during implantation. The windows 4a and 4b are
created through the Ilium to gain direct line of site access to the
L4-L5 and L5-S1 intervertebral spaces, respectively. This is a
highly invasive approach, creates significant tissue damage,
particularly to the Ilium and surrounding soft tissue, and requires
significant surgical skill.
[0006] Second, the steep approach angle (8a for the L4-L5
intervertebral space and 8b for the L5-S1 intervertebral space), as
measured from a transverse plane along the approach path (10a for
the L4-L5 intervertebral space and 10b for the L5-S1 intervertebral
space) of a tissue retractor relative to the location of the fusion
site, can cause problems, as illustrated in FIGS. 3 and 4. The
approach paths 10a and 10b pass through the skin surface 12. The
tissue retractor used in lateral fusion surgery provides line of
site access to the disk space requiring a fusion cage insertion.
The tissue retractor holds tissue out of the way of the procedure.
The tissue retractor is also used to create a working channel to
pass tools through, protect neural tissue, and anchor to the
superior and inferior vertebral bodies relative the disk space
requiring fusion. The volume within the pelvis and inferior to the
dashed demarcation line 6 along a transverse plane is very hard if
not impossible to reach with a direct lateral approach due to the
Ilium. Even if the retractors are tilted as shown by the
demarcation line 6, the ability to insert an implant that is the
length of the end plates of the L4 or L5 vertebral bodies would be
very difficult due to obstruction of the Ilium among other
factors.
[0007] Furthermore, with the retractor positioned along the
approach path 10a or 10b plane and angled direction, the angle
formed between the retractor and the vertebral body end plates
would make inserting a monolithic, inflexible fusion cage 14 or
implant into the L5-S1 intervertebral space difficult if not
virtually impossible due to obstruction of the surrounding hard and
soft tissue, as illustrated by FIG. 5a. A typical lateral fusion
cage or implant width 16 is the width of the end plate 18 along the
adjacent disk. The implant 14 can not turn the corner at the pivot
point 20 at the lateral and/or anterior edge of the L5-S1
intervertebral space.
SUMMARY OF THE INVENTION
[0008] Support or fixation devices and methods for access,
controlling (e.g., steering or rotating, and driving or
translating) implants, and modifying the configuration of implants
are disclosed. The device can be an implantable fixation device,
such as a flexible and/or articulatable fusion cage. The device can
articulate and/or bend so the device can make the turn around the
L5-S1 intervertebral space. The implant can flex and/or articulate.
For example, the implant can have hinges and/or be flexible (e.g.,
have significantly elastic structural components).
[0009] Articulation tools are disclosed that can be used to implant
the device. The articulation tools can articulate the device and/or
allow the device to articulate. For example, the connection between
the articulation tool and the implant can bend, flex, steer, or
combinations thereof. The articulation tools can be used to debride
or clear out the disk space.
[0010] An oblique curved access tool or device can be used. The
device can be delivered to the intervertebral space along an
oblique approach path, not perpendicular to the spine. The oblique
approach can provide an access path from lateral skin to the L5-S1
disk space, and can curve tangent to the Ilium. A large working
channel through the soft tissue can be created. The oblique access
tool can move soft tissue out of the way to create the working
channel. The oblique approach can reduce the
access-tool-to-disk-space approach angle.
[0011] A biological implant support device for providing orthopedic
support is disclosed. The device can be articulatable or flexible.
The device can have a first rigid section at a first terminal end
of the device. The first rigid section can have a first top plate
and a first bottom plate. The device can have a second rigid
section having a second top plate and a second bottom plate. The
first rigid section can be rotatably attached to the second rigid
section. The top and bottom plates can be configured to interface
with hard tissue.
[0012] A method for inserting a support device to a target site in
a spine adjacent to a first vertebra is disclosed. The method can
include creating a channel through a non-vertebral bone. The method
can include inserting a first rigid section of the device through
the channel and into the target site. The method can include
inserting a second rigid section of the device through the channel.
The method can include rotating the second rigid section of the
implant with respect to the first rigid section. The first rigid
section can be hingedly attached to the second rigid section. The
method can include inserting the second rigid section of the
implant into the target site.
[0013] Creating the channel can include drilling the tissue with a
flexible drill. The non-vertebral bone can be the pelvis, such as
the ilium and/or the sacrum.
[0014] A method for inserting an implant to a target site between a
first vertebra and a second vertebra is disclosed. The method can
include creating a first channel through the ilium. The method can
include creating a second channel through the sacrum. The first
channel can be aligned with the second channel. The method can
include inserting a first rigid section of the implant through the
first channel and the second channel into the target site. The
method can include rotating a second rigid section of the implant
with respect to the first rigid section, wherein the first rigid
section is hingedly attached to the second rigid section. The
method can include inserting the second rigid section of the
implant into the target site. The second channel can pass through a
port formed in vertebral endplate. The device can be inserted
through the port in the vertebral endplate and articulate as the
device is delivered into the target site.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] FIGS. 1a and 1b are anterior and lateral views,
respectively, of the lower lumbar and sacral spine and pelvis with
the Ilium shown in phantom lines in FIG. 1b.
[0016] FIG. 2 is a lateral view of the lower lumbar spine with
windows cut through the Ilium.
[0017] FIGS. 3 and 4 are anterior and lateral views, respectively,
of the lower spine and pelvis along with approach paths into the
intervertebral spaces.
[0018] FIG. 5a is an anterior close-up view of the lower spine and
pelvis with an approach of a monolithic implant.
[0019] FIG. 5b illustrates a variation of the implantable
device.
[0020] FIGS. 5c and 5d illustrate a variation of a method of
delivering the device of FIG. 5b into the L5-S1 space.
[0021] FIGS. 6 through 8 are anterior, perspective and lateral
views, respectively, of a variation of the approach path for
delivering the implant into the intervertebral space.
[0022] FIGS. 9a through 9d illustrate variations of the device in
various configurations. An x-axis, y-axis and z-axis are also shown
for orientation with the x-axis disposed along the longitudinal
axis of the device.
[0023] FIGS. 10a and 10b illustrate various configurations of a
variation of the device in a steering tube with the tube shown as
see-through for illustrative purposes.
[0024] FIGS. 10c through 10e illustrate various configurations of a
variation of the device on steering rails attached to the lateral
outside of the device.
[0025] FIGS. 11a through 11c illustrate various configurations of a
variation of the device on a steering rail attached to the inside
of the device.
[0026] FIGS. 12a through 12f are cross-sections of various steering
rails, or along the length of the same steering rail.
[0027] FIG. 13 illustrates a method for deploying the device into
the L5-S1 intervertebral space.
[0028] FIGS. 14a and 14b illustrate various configurations of a
variation of the device in a steering slide.
[0029] FIGS. 15a and 15b are top and side views of a variation of
the device with parallel hinges.
[0030] FIG. 16 is a top view of a variation of the device with
non-parallel hinges.
[0031] FIGS. 17a through 17f are side views of variations of the
device.
[0032] FIGS. 18 and 19 are perspective views showing the
orientation of variations of living hinges within devices.
[0033] FIGS. 20a through 20c are perspective, top and front views,
respectively, of a variation of the device in a straight or flat
configuration.
[0034] FIGS. 21a through 21c are perspective, top and front views,
respectively, of the device of FIGS. 20a through 20c in an
articulated configuration.
[0035] FIGS. 22a through 22c are perspective, top and front views,
respectively, of a variation of the device in a straight or flat
configuration.
[0036] FIGS. 23a through 23c are perspective, top and front views,
respectively, of the device of FIGS. 22a through 22c in an
articulated configuration.
[0037] FIG. 24 illustrates the lower spine and pelvis.
[0038] FIGS. 25 through 28 illustrate a variation of a method of
delivering the device to a target site.
[0039] FIGS. 29 through 31 illustrate views through the transverse
plane from a superior location, the sagittal plane from a lateral
location, and the coronal plane from an anterior location,
respectively, of a variation of the location of the transosseous
delivery channel.
[0040] FIGS. 32a through 32d illustrate a superior view of a
variation of a method of delivering the device showing the iliac
and sacrum, but not the L5-S1 disc or remainder of the spine for
illustrative purposes.
[0041] FIGS. 33a through 33d illustrate a posterior perspective
view of a variation of a method of delivering the device showing
the iliac and sacrum, but not the L5-S1 disc or remainder of the
spine for illustrative purposes.
DETAILED DESCRIPTION
[0042] Support or fixation devices and methods for access,
controlling (steering) implants, and modifying implants are
disclosed. The support device disclosed herein can be used to treat
one or more osseous structures in the body including the L4-L5 and
L5-S1 region of the spine. The device can be used with known
methods of accessing the vertebrae of the spine such as the L4-L5
and L5-S1 regions with posterior, anterior, or lateral approaches,
or combinations thereof.
[0043] The device can be an implantable fixation device, such as a
flexible fusion cage. The device can be delivered into an
intervertebral space, for example, to provide structural support
between the adjacent vertebrae. The device can fuse the vertebra
adjacent to the specific intervertebral space. A discectomy can be
performed at the target implant site before or during delivery of
the implant.
[0044] FIGS. 5a through 5c illustrate that the device can be
articulatable or flexible. The implantable device 10 can be used to
support and/or fix structures between adjacent vertebrae, such as
between the L4 and L5 vertebrae or between the L5 and S1 vertebrae.
The implantable device 10 can be articulatable and/or flexible so
as to navigate sharp anatomical turns, such as the L4-L5 or L5-S1
intervertebral space. The implantable device 10 can be rigidly
lockable or can remain flexible or articulatable at all times. The
implantable device 10 can be rigidly locked for example using a
delivery tool, e.g., wires, sheaths, guides, or combinations
thereof, for example, for additional stability. Such surgical
delivery tools, alone or in combination, may add axial strength and
stability before during or after pressing the implantable device 10
into the targeted intervertebral disc space.
[0045] FIG. 5b illustrates that the implantable device 14 can have
first, second, third, and fourth segments 22a through 22d. Each of
the segments 22a, 22b, 22c, and 22d can be attached to the adjacent
segment at a flex point or articulatable hinge 24a, 24b, and 24c,
respectively. The device 14 can articulate and/or bend at the
hinges 24.
[0046] FIGS. 5c and 5d illustrate that the device 14 can be
delivered into the L5-S1 intervertebral space. The device 14 can
make the turn around the L5-S1 intervertebral space, such as at the
pivot point 20, by articulating or flexing.
[0047] FIGS. 6 through 8 shows illustrate a curved implant pathway
or approach path 10c. An articulation tool can be used to push
(e.g., impact), pull, control or combinations thereof, the implant
14. The implant 14 can articulate and/or flex during delivery. The
implant can have single or multiple hinges, a flexible shaft, laser
slots (e.g., in a tube to act as hinges) or combinations
thereof.
[0048] The approach path 10c can be tangential to the medial
surface of the Ilium along a portion of the length of the approach
path 10c. A portion of the length of the approach path 10c can be
linear and a portion of the length of the approach path 10c can be
curved. The entire approach path 10c can be linear or curved. A
portion of the length of the approach path 10c can track (i.e.,
follow the same shape of) the medial surface of the Ilium. The
approach path 10c can contact the medial surface of the Ilium 2.
The approach path 10c can be non-perpendicular or perpendicular to
the longitudinal axis 27 of the spine where the approach path 10c
enters the intervertebral space L4-L5 or L5-S1.
[0049] The approach-Ilium gap 26 can be measured between the
approach path 10c and the closest medial surface of the Ilium 2.
The approach-Ilium gap 26 can be perpendicular to the approach path
10c and the Ilium 2, for example when the approach path 10c is
tracking the medial surface of the Ilium 2. The approach-Ilium gap
26 can be from about 0 mm to about 15 mm along the length of the
approach path 10c where the approach path is tracking the medial
surface of the Ilium 2, more narrowly from about 0 mm to about 10
mm, yet more narrowly from about 2 mm to about 8 mm.
[0050] The approach path 10c can be curved in all three dimensions
(e.g., in the transverse plane, sagittal plane and coronal plane),
or any combination thereof and straight in the remaining
dimensions.
[0051] FIG. 9a through 9d illustrate that variations of hinges 24a
and 24b between the segments 22a, 22b and 22c can allow the implant
14 to articulate. The implant 14 can have controlled angulation or
articulation (i.e., with discrete, defined built-in stopping points
or stops) or free angulation or articulation (i.e., with no
stops).
[0052] FIG. 9a illustrates that the hinges 24a and 24b can be
oriented in parallel with the z-axis. The hinges can have a single
degree of rotational freedom. The segments 24, 24b and 24c can
articulate by rotating about the z-axis with respect to each other.
The hinges 24a and 24b can be near the top (as shown), near the
bottom, in the middle with respect to the y-axis, or combinations
thereof of the device 14.
[0053] FIG. 9b illustrates that the hinges 24a and 24b can be
oriented in parallel with the x-axis. The segments 24, 24b and 24c
can articulate by rotating about the x-axis with respect to each
other. The hinges 24a and 24b can be near the front (as shown),
near the rear, in the middle with respect to the z-axis, or
combinations thereof of the device 14.
[0054] FIG. 9c illustrates that the hinges 24a and 24b can be
oriented in parallel with the y-axis. The segments 24, 24b and 24c
can articulate by rotating about the y-axis with respect to each
other. The hinges 24a and 24b can be near the front (as shown),
near the rear, in the middle with respect to the z-axis, or
combinations thereof of the device 14.
[0055] FIG. 9d illustrates that the hinges 24a and 24b can be
ball-in-socket hinges allowing three rotational degrees of freedom,
or a combination of the three hinges described in FIGS. 9a through
9c, allowing two or three degrees of freedom. The segments 24, 24b
and 24c can articulate by rotating about the x-axis, and/or y-axis,
and/or z-axis with respect to each other. The hinges 24a and 24b
can be near the front (as shown), near the rear, in the middle with
respect to the z-axis, near the top, near the bottom, in the middle
with respect to the y-axis (as shown), or combinations thereof of
the device 14.
[0056] The first hinge 24a can be located in a different location
and/or with a different than the second hinge 24b. For example, the
first hinge 24a can be oriented in parallel with the z-axis, allow
rotation about the z-axis and be located near the top of the device
14, and the second hinge 24b can be oriented in parallel with the
x-axis, allow rotation about the x-axis, and be located near the
middle of the device 14 with respect to the z-axis.
[0057] FIGS. 10a and 10b illustrate that the device 14 can have an
outer steering sheath or tube 28. The device 14 can be fixed to the
steering tube 28 or can slide along the steering tube 28. The
steering tube 28 can be articulatable and/or flexible, as shown by
the arrow in FIG. 10b and the various configurations of the tube 28
between FIGS. 10a and 10b. The articulation or flexion of the
steering tube 28 can be controlled, for example by delivering
controlled tension to tensile control wires in the walls of the
steering tube 28.
[0058] The steering tube 28 can be positioned at the target
deployment site. For example, the steering tube 28 can be placed in
the intervertebral space and can remain in the intervertebral space
post-surgery, or the steering tube 28 can be removed from the
intervertebral space and the device 14 can be deployed from the
tube 28 and the device 14 can be left in the intervertebral
space.
[0059] Also for example, the distal end of the steering tube 28 can
be positioned at the entrance to the intervertebral space and/or
rested on the inferior and/or superior vertebral body end plate
adjacent to the target intervertebral space. The device 14 can then
be pushed (e.g., by a plunger) out of the steering tube and into
the intervertebral space. The steering tube 28 does not have to,
but can, enter the intervertebral space.
[0060] FIGS. 10c through 10d illustrate that the device 14 can have
one or more exterior steering rails, tracks or wires 30a and 30b,
such as guidewires. The rails 30a and 30b can slidably or fixedly
and releasably engage the external surface of the segments 22 of
the device 14. For example, the rails can pass through slots,
guides, collars, cuffs or combinations thereof on the exterior of
the segments 22. The slots, guides, collars, cuffs or combinations
thereof, and/or the rails 30a and 30b can be coated or covered with
a low-friction (e.g., PTFE) or high-friction (e.g., knurled or
toothed surface texturing) material or surface treatment or
texture, including any of the materials listed herein. The steering
rails 30a and 30b can be steered or manipulated by applying a
tensile force to tensile cables within the rails, as shown by the
arrows in FIGS. 10d and 10e, and the flexing from FIGS. 10c to 10d.
The rails 30a and 30b can be pre-formed to a specific shape and can
be substituted for other rails 30a and 30b that can be pre-formed
to a different shape to change the direction of delivery.
[0061] FIGS. 11a through 11c illustrates that the device 14 can
have one or more interior steering rails, guide, tracks or wires
30, such as guidewires. The rails 30 can be positioned through the
center or interior of one or more segments 22 of the device 14. The
rail 20 can slidably or fixedly and releasably engage an internal
surface, such as through a longitudinal guide port or channel 32,
of the segments 22 of the device 14. For example, ports or channels
can extend longitudinally through the segments 22 of the device 14.
The channels, and/or the rail 30 can be coated, covered or
collared, such as with a low-friction (e.g., PTFE) or high-friction
(e.g., knurled or toothed surface texturing) material or surface
treatment or texture, including any of the materials listed herein.
The steering rail 30 can be steered or manipulated by applying a
tensile force to tensile cables within the rail 30, as shown by the
flexing from FIGS. 11a to 11c. The rail 30 can be pre-formed to a
specific shape and can be substituted for one or more other rails
30 that can be pre-formed to a different shape to change the
direction of delivery.
[0062] The distal ends of the internal and/or external steering
rail or rails 30 can be positioned at the target deployment site.
For example, the steering rails 30 can be placed in the
intervertebral space and can remain in the intervertebral space
post-surgery, or the steering rails 30 can be removed from the
intervertebral space and the device 14 can be deployed from the
rails 30 and the device 14 can be left in the intervertebral
space.
[0063] Also for example, the distal end of the steering rails 30
can be positioned at the entrance to the intervertebral space
and/or rested on the inferior and/or superior vertebral body end
plate adjacent to the target intervertebral space. The device 14
can then be pushed (e.g., by a plunger) out of the steering rails
30 and into the intervertebral space. The steering rails 30 do not
have to, but can, enter the intervertebral space.
[0064] FIGS. 12a through 12f illustrate cross-sections of various
rails 30, or at various lengths along the same rail 30. FIG. 12a
illustrates that the cross-section of the steering rail 30 can be
circular. FIG. 12b illustrates that the cross-section of the
steering rail 30 can be oval. FIG. 12c illustrates that the
cross-section of the steering rail 30 can be multi-ovular (i.e.,
having a union of two or more ovals with the same major axis). FIG.
12d illustrates that the cross-section of the steering rail 30 can
be the union of rectangles intersecting at right (or another)
angle, such as a plus-sign. FIG. 12e illustrates that the
cross-section of the steering rail 30 can be hexagonal. FIG. 12f
illustrates that the cross-section of the steering rail 30 can be
rectangular or square with sharp or rounded (chamfered) edges. The
cross-section of the steering rail 30 can be triangular,
pentagonal, heptagonal, or octagonal. The steering rail 30, whether
internal or external to the device 14, can deliver torque around
the longitudinal and/or transverse axes of the device. The steering
rail 30 can have various cross sections at various lengths along
the rail 30. The steering rail 30 can guide, pitch, yaw and roll
the device 14 into a desired orientation or indication. The device
14 can be delivered with one or more internal and/or external rails
30 and/or a sheath 28 or neither.
[0065] FIG. 13 illustrates a device 14 that can be attached to a
deployment tool having a controller handle 34 controllably attached
to the internal steering rail 30. The internal steering rail 30 can
pass through the device 14. The steering rail 30 can be fixedly
attached to the device 14 during the delivery and articulation of
the device 14. The device can be steered along or tracking the
medial surface of the Ilium 2. The device 14 can then be positioned
adjacent to the target site (e.g., the L5-S1 intervertebral space).
The deployment tool can then release the device 14 from the
steering rail 30 and push the device 14 into the target site.
[0066] FIGS. 14a and 14b illustrate that the device 14 can be
delivered by being pushed along a steering horn, boot, or slide 36.
The slide 36 can be similar to the steering tube 28, except that at
least one wall of the slide 36 can be missing or open (e.g., the
top wall is not present in the variation of the slide shown)
compared with the steering tube 28. The missing wall can be
completely open or replaced by one or more steering rails 30. The
slide 36 can be used similar to the steering rails 30 and/or
steering tube 28. The slide 36 can be steered, flexed or
articulated by applying a tensile force to tensile cables within
the rails, as shown by the arrow in FIG. 14b, and the flexing from
FIGS. 14a to 14b.
[0067] FIGS. 15a and 15b illustrate that the device 14 can have six
segments 22a through 22f and five hinges 24a through 24e. The
segments 22 can be attached to adjacent segments 22 by one or more
hinges, tension or steering rails or wires, screws, pins, or
combinations thereof. The hinges 24 can be pins. The segments 22
can be chained together. The segments 22 can be identical to each
other except for the distal-most segment 22a and the proximal-most
segment 22f. The segments 22 or links can be box-shaped. The hinges
24, such as the pins, can be parallel to all or some of the other
hinges 24.
[0068] FIG. 16 illustrates that the hinges 24 can be at acute
angles to all or some of the hinges 24. The hinges 24 can be at
hinge angles 38 with respect to each other. The hinge angle 38 can
be measured between the hinge longitudinal axis 40 and the device
longitudinal axis 42. The hinge angles 38 can be from about
80.degree. to about 150.degree., more narrowly from about
90.degree. to about 135.degree., yet more narrowly from about
95.degree. to about 110.degree..
[0069] The device 14 can be translated and/or rotated by a handle
34 that can be removably attached to the device 14. The handle 34
can be screwed and/or snapped directly into the proximal end of the
device 14, such as into the proximal-most segment 22. The handle 34
can compress, such as by grabbing or pinching, the proximal end of
the device 14. The handle 34 can be a pusher, plunger, ram, or
combinations thereof. The handle 34 and/or remainder of the
deployment tool can be rigid and/or flexible or articulatable. For
example, hinged similar to the device 14.
[0070] The segments 22 are not necessarily connected to each other
by hinges. The segments 22 can be delivered to the target site
individually, or as an unattached line of segments 22.
[0071] The device 14 can be cylindrical and flexible. The
implantable device 14 can be fully flexible all the time. The
device 14 can be mechanically stabilized by the deployment tool,
steering wires, sheaths, tubes and guides. For example, the tools,
wires, sheaths, tubes and guides can provide column stability to
press the device 14 into the target site (e.g., intervertebral disc
space).
[0072] The device 14 can flexible, and then locked with a tension
or steering wire to stop rotational motion of the hinges once the
device is delivered to and oriented within the target site. The
tension wire could be tightened, for example by being tensioned by
a nut to create higher friction in each hinge 24.
[0073] FIGS. 17a through 17f illustrate that the device 14 can have
a living hinge 44. The living hinge 44 is a length of decreased
rigidity and increased flexing within the body of the device 14.
The living hinge 44 can be formed around slots and continuous
segments of otherwise tough, durable material. The living hinge 44
can be defined be narrowing or thinning in the body of the device
14, such that the narrowing is sufficient to provide flexibility
under reasonable torque. For example, the thickness of the unitary
body of the device 14 at the living hinge 44 can be narrowed by
more than about 85%, or more than about 90%, or more than about
95%, or more than about 97%, or more than about 98.5%. The living
hinge 44 can have one or more repeated thinnings along the length
of the device 14, as shown in FIGS. 17a through 17f.
[0074] FIGS. 17a and 17b illustrate that the device 14 bends at the
living hinge 44. The living hinges 44 can be made to control the
bend and direction of the device 14. The outer surface of the
device 14 along the living hinge 44 can be smooth, for example
providing low-friction surface for sliding over bone.
[0075] FIGS. 17a and 17b illustrate that the living hinge 44 can be
along the bottom of the implant device 14. FIG. 17c illustrates
that the living hinge 44 can be along the top of the device 14.
FIG. 17d illustrates that the living hinge 44 can be through the
middle or central axis of the device 14. FIG. 17e illustrates that
the living hinge 44 is discontinuous and on opposite sides of the
center of the device 44. FIG. 17f illustrates that the living hinge
44 is at an angle with respect to the longitudinal axis of the
device 14, starting near the bottom of the device 14 and ending
near the top of the device 14.
[0076] FIG. 18 illustrates that the living hinge 42 can be at a
non-zero angle to the central longitudinal axis 42 of the device
14. A first length of the living hinge 42 can be at a non-zero
angle to a second length of the living hinge 44.
[0077] FIG. 19 illustrates that the living hinge 44 can be curved.
The living hinge 44 can curve around the central longitudinal axis
42 of the device 14.
[0078] FIGS. 20a through 20c illustrate that the device can have
three segments 22a, 22b and 22c connected by two hinges 24a and
24b. The device longitudinal axis 42 can be straight or can have a
longitudinal radius of curvature 46. The longitudinal radius of
curvature 46 can be from about 3 cm to about 100 cm, more narrowly
from about 5 cm to about 20 cm, yet more narrowly from about 7 cm
to about 15 cm, for example about 15 cm, also for example about 10
cm.
[0079] The support device 14 can have a support device width 11a, a
support device length 11b and a support device height 11c. The
support device width 11a can be from about 10 mm to 30 mm, or more
narrowly 16 mm to about 18 mm. The support device length 11b can be
from about 30 mm to 60 mm, or more narrowly from 45 mm to about 55
mm. The support device height 11c can be from about 1 mm to 30 mm,
or more narrowly from 8 mm to about 16 mm.
[0080] The device 14 can have an anterior taper or lordosis angle
48. The taper angle 48 can be measured between the plane of the top
surface and the plane of the bottom surface of the device 14. The
taper angle 48 can be from about 0.degree. (i.e., parallel top and
bottom planes) to about 45.degree., more narrowly from about
2.degree. to about 20.degree., yet more narrowly from about
0.degree. to about 12.degree., yet more narrowly from about
4.degree. to about 10.degree., yet more narrowly from about
4.degree. to about 8.degree., for example from about 0.degree.,
also for example about 6.degree..
[0081] The first, second, and third links or segments 22a, 22b and
22c of the flexible implantable device 14 may be separate or
connected. One or more of the segments 22 can be rigid and/or
flexible. One or more of the segments 22 can have through-ports or
segment ports 50, such as first, second and third segment ports
50a, 50b and 50c, through the first, second and third segments 22a,
22b, and 22c, respectively. The segment ports 50 can extend through
part of all of the height of the respective segment 22 or the
device 14 from the top to the bottom surface. One or more of the
segment ports 50 can be partially or completely filled with a bone
ingrowth matrix, bone morphogenic protein, therapeutic agents, any
agent or material disclosed herein, or combinations thereof, for
example for analgesic effect or to promote bone ingrowth.
[0082] The device 14 can have a surface coating or texturing on the
top, and/or bottom, and/or side surfaces, such as lateral teeth 52,
longitudinal or angled teeth, knurling, a coating or matrix to
promote bone ingrowth, or combinations thereof.
[0083] The device 14 can have hinge teeth or knuckles 54. The hinge
teeth 54 can slide by adjacent hinge teeth 54 to increase lateral
stability during articulation and increase range of motion (e.g., a
hinge tooth 54 on one segment 22 can slide into the gap between
hinge teeth 54 on the adjacent segment 22 during articulation of
the device 14).
[0084] One or more tension and/or steering wires can be inserted
and/or tensioned through guide ports or channels 32a and 32b. The
guide channels 32a and 32b can extend longitudinally through some
or all of the segments 22.
[0085] The first segment 22a and the third segment 22c can have
central vertical holes 82a and 82b, respectively. The central
vertical holes 82 can be attached to a deployment device, screwed
to the adjacent tissue (i.e., bone) after delivery, filled with a
radiopaque material for visualization or therapeutic or other
material listed herein, or combinations thereof.
[0086] FIGS. 21a through 21c illustrate that device 14 can
articulate. The segments 22 can rotate with respect to each other
about the hinges 24, as shown by arrows.
[0087] The first segment 22a can have a first segment longitudinal
axis 42a. The second segment 22b can have a second segment
longitudinal axis 42b. The third segment 22c can have a third
segment longitudinal axis 42c. The respective longitudinal axes can
intersect at the adjoining hinge pins 24. The first segment
longitudinal axis 42a can form a first articulation angle 80a with
the second segment longitudinal axis 42b. The second segment
longitudinal axis 42b can form a second articulation angle 80b with
the third segment longitudinal axis 42c. The first and second
articulation angles 80a and 80b can be the same or different. When
the device is in an articulated configuration, the first and/or
second articulation angles 80a and/or 80b can be from about
0.degree. to about 90.degree., more narrowly from about 3.degree.
to about 75.degree., yet more narrowly from about 5.degree. to
about 60.degree., yet more narrowly from about 15.degree. to about
45.degree..
[0088] FIGS. 22a through 22c illustrate that some or all of the
distal-most segments 22a through 22d can be identical. Segments 22
can be added or removed from the device 14, before during or after
deployment to the target site, to increase or decrease the length
of the device 14 to best fit the target site. The false hinge 24'
can be a hinge component that is not attached to the other half of
the hinge 24. The hinges 24 can snap together and apart. The
articulation of each segment 22 can be limited by the interference
fit of a rotational stop 58 on the top and bottom of the adjacent
segment 22.
[0089] The device 14 can have a deployment tool interface, such as
the lateral hole 56, for attaching to the deployment tool.
[0090] FIGS. 23a through 23c illustrate that a tensioning or
steering wire or rail 30 can be deployed through the channels 32 on
each segment. The wire 30 can then be tensioned to articulate
and/or lock the device 14 in an articulated configuration.
[0091] PCT Application No. PCT/US 11/00974 filed 27 May 2011 which
claims priority to U.S. Provisional App. No. 61/349,151 filed 27
May 2010 are both herein incorporated by reference in their
entireties.
[0092] Any or all elements of the device and/or other devices or
apparatuses described herein can be made from, for example, a
single or multiple stainless steel alloys, nickel titanium alloys
(e.g., Nitinol), cobalt-chrome alloys (e.g., ELGILOY.RTM. from
Elgin Specialty Metals, Elgin, Ill.; CONICHROME.RTM. from Carpenter
Metals Corp., Wyomissing, Pa.), nickel-cobalt alloys (e.g.,
MP35N.RTM. from Magellan Industrial Trading Company, Inc.,
Westport, Conn.), molybdenum alloys (e.g., molybdenum TZM alloy,
for example as disclosed in International Pub. No. WO 03/082363 A2,
published 9 Oct. 2003, which is herein incorporated by reference in
its entirety), tungsten-rhenium alloys, for example, as disclosed
in International Pub. No. WO 03/082363, polymers such as
polyethylene teraphathalate (PET)/polyester (e.g., DACRON.RTM. from
E. I. Du Pont de Nemours and Company, Wilmington, Del.),
polypropylene, (PET), polytetrafluoroethylene (PTFE), expanded PTFE
(ePTFE), polyether ketone (PEK), polyether ether ketone (PEEK),
poly ether ketone ketone (PEKK) (also poly aryl ether ketone
ketone), nylon, polyether-block co-polyamide polymers (e.g.,
PEBAX.RTM. from ATOFINA, Paris, France), aliphatic polyether
polyurethanes (e.g., TECOFLEX.RTM. from Thermedics Polymer
Products, Wilmington, Mass.), polyvinyl chloride (PVC),
polyurethane, thermoplastic, fluorinated ethylene propylene (FEP),
absorbable or resorbable polymers such as polyglycolic acid (PGA),
polylactic acid (PLA), polycaprolactone (PCL), polyethyl acrylate
(PEA), polydioxanone (PDS), and pseudo-polyamino tyrosine-based
acids, extruded collagen, silicone, zinc, echogenic, radioactive,
radiopaque materials, a biomaterial (e.g., cadaver tissue,
collagen, allograft, autograft, xenograft, bone cement, morselized
bone, osteogenic powder, beads of bone) any of the other materials
listed herein or combinations thereof. Examples of radiopaque
materials are barium sulfate, zinc oxide, titanium, stainless
steel, nickel-titanium alloys, tantalum and gold.
[0093] Any or all elements of the device and/or other devices or
apparatuses described herein, can be, have, and/or be completely or
partially coated with agents and/or a matrix a matrix for cell
ingrowth or used with a fabric, for example a covering (not shown)
that acts as a matrix for cell ingrowth. The matrix and/or fabric
can be, for example, polyester (e.g., DACRON.RTM. from E. I. Du
Pont de Nemours and Company, Wilmington, Del.), polypropylene,
PTFE, ePTFE, nylon, extruded collagen, silicone or combinations
thereof.
[0094] The device and/or elements of the device and/or other
devices or apparatuses described herein and/or the fabric can be
filled, coated, layered and/or otherwise made with and/or from
cements, fillers, glues, and/or an agent delivery matrix known to
one having ordinary skill in the art and/or a therapeutic and/or
diagnostic agent. Any of these cements and/or fillers and/or glues
can be osteogenic and osteoinductive growth factors.
[0095] Examples of such cements and/or fillers includes bone chips,
demineralized bone matrix (DBM), calcium sulfate, coralline
hydroxyapatite, biocoral, tricalcium phosphate, calcium phosphate,
polymethyl methacrylate (PMMA), biodegradable ceramics, bioactive
glasses, hyaluronic acid, lactoferrin, bone morphogenic proteins
(BMPs) such as recombinant human bone morphogenetic proteins
(rhBMPs), other materials described herein, or combinations
thereof.
[0096] The agents within these matrices can include any agent
disclosed herein or combinations thereof, including radioactive
materials; radiopaque materials; cytogenic agents; cytotoxic
agents; cytostatic agents; thrombogenic agents, for example
polyurethane, cellulose acetate polymer mixed with bismuth
trioxide, and ethylene vinyl alcohol; lubricious, hydrophilic
materials; phosphor cholene; anti-inflammatory agents, for example
non-steroidal anti-inflammatories (NSAIDs) such as cyclooxygenase-1
(COX-1) inhibitors (e.g., acetylsalicylic acid, for example
ASPIRIN.RTM. from Bayer AG, Leverkusen, Germany; ibuprofen, for
example ADVIL.RTM. from Wyeth, Collegeville, Pa.; indomethacin;
mefenamic acid), COX-2 inhibitors (e.g., VIOXX.RTM. from Merck
& Co., Inc., Whitehouse Station, N.J.; CELEBREX.RTM. from
Pharmacia Corp., Peapack, N.J.; COX-1 inhibitors);
immunosuppressive agents, for example Sirolimus (RAPAMUNE.RTM.,
from Wyeth, Collegeville, Pa.), or matrix metalloproteinase (MMP)
inhibitors (e.g., tetracycline and tetracycline derivatives) that
act early within the pathways of an inflammatory response. Examples
of other agents are provided in Walton et al, Inhibition of
Prostoglandin E.sub.2 Synthesis in Abdominal Aortic Aneurysms,
Circulation, Jul. 6, 1999, 48-54; Tambiah et al, Provocation of
Experimental Aortic Inflammation Mediators and Chlamydia
pneumoniae, Brit. J. Surgery 88 (7), 935-940; Franklin et al,
Uptake of Tetracycline by Aortic Aneurysm Wall and Its Effect on
Inflammation and Proteolysis, Brit. J. Surgery 86 (6), 771-775; Xu
et al, Sp1 Increases Expression of Cyclooxygenase-2 in Hypoxic
Vascular Endothelium, J. Biological Chemistry 275 (32) 24583-24589;
and Pyo et al, Targeted Gene Disruption of Matrix
Metalloproteinase-9 (Gelatinase B) Suppresses Development of
Experimental Abdominal Aortic Aneurysms, J. Clinical Investigation
105 (11), 1641-1649 which are all incorporated by reference in
their entireties.
[0097] Methods of Use
[0098] FIG. 24 illustrates that a straight or curved transosseous
delivery channel 94 can be drilled, chiseled, punched, or a
combination thereof, through the iliac bone 2 and/or the sacral ala
90, for example passing through the sacroiliac joint 92. The
transosseous delivery channel 94 have a first length or first
channel through the iliac 2 and a second length or second channel
through the sacrum S1. The first length of the transosseous
delivery channel 94 can be aligned with the second length of the
transosseous delivery channel 94, for example to form a
substantially continuous channel. The transosseous delivery channel
94 can have a laterally-located channel entry port 96 laterally
outside of the sacral ala 90 and/or iliac bone 2. The transosseous
delivery channel 94 can have a channel exit port 98 adjacent to the
L5-S1 intervertebral disc space. For example, the channel exit port
98 can be in the S1 endplate. The channel exit port 98 can be
positioned so the circumference of the channel exit port 98
tangentially coincides with or is closely adjacent to (e.g., within
about 2 cm, more narrowly within about 1 cm, more narrowly within
about 5 mm, yet more narrowly within about 2 mm) with the edge of
the S1 vertebral endplate 100.
[0099] The L5-S1 intervertebral space can be partially or
completely void of soft tissue, as shown, for example from a
discectomy performed before insertion of the support device 14. For
example, the discectomy can be performed by the method and device
shown in U.S. Provisional Patent Application No. 61/526,630 filed
23 Aug. 2011, which is incorporated by reference herein in its
entirety.
[0100] FIG. 25 illustrates that the support device 14 can be
inserted, as shown by arrow 102, medially through the channel entry
port 96 of the transosseous delivery channel 94. The device 14 can
be removably and/or articulatably attached to a deployment tool
shaft 104.
[0101] FIG. 26 illustrates that the shaft 104 can be further
translated, as shown by arrow 106, into the transosseous delivery
channel 94. The support device 14 can translate toward and into the
L5-S1 intervertebral disc space. The distal tip of the support
device 14 can enter the L5-S1 intervertebral disc. The support
device 14 can enter the target site of the L5-S1 intervertebral
disc directly from the transosseous delivery channel 94 without
passing through any soft tissue between the L5-S1 intervertebral
disc and the iliac bone 2.
[0102] FIG. 27 illustrates that the shaft 104 can be further
translated, as shown by arrow 108, medially through the
transosseous delivery channel 94. The device 14 can translate, as
shown by arrow 110, through the L5-S1 intervertebral disc space and
the L5 and/or the S1 vertebra. The support device 14 can
articulate, as shown by arrow 112. One or more of the hinges 24 can
rotate, articulating the segments 22. The hinges 24 can be
controllably rotatably locked and unlocked, for example, by
controls on the handle of the deployment tool (of which the shaft
104 is a part).
[0103] The support device 14 can then be further translated, such
as being pushed and/or vibrated (e.g., manually, ultrasonically),
for example, medially and laterally, and/or superior and
inferiorly, and/or anteriorly and posteriorly. The through ports
and/or cavities and/or recesses 50 in the device 14 can be
partially and/or completely filled bone morphogenic protein,
therapeutic agents, other materials listed herein or combinations
thereof. The support device 14 can deliver a cauterizing electrical
energy from the deployment tool. The support device 14 and shaft
104 can have one or more longitudinal lumens that can be used to
irrigate (e.g., with analgesic agents, saline, anesthetic agents,
bone morphogenic proteins, visualization agents, other agents
described herein, or combinations thereof) and/or aspirate (e.g.,
to remove irrigated material and/or debris) the target site (e.g.,
the L5-S1 intervertebral disc space).
[0104] FIG. 28 illustrates that before, during or after the support
device 14 is positioned in the L5-S1 intervertebral space, the
shaft 104 can detach from the support device 14 and be translated
laterally, as shown by arrow 114, from the L5-S1 intervertebral
disc space and the transosseous delivery channel 94. The deployment
tool shaft 104 can remove or reposition the support device 14, or
leave the support device 14 in place in the L5-S1 space.
[0105] The method shown in FIGS. 25 through 28 can be repeated to
deliver multiple support devices 14 to one or more intervertebral
spaces. For example, one, two, three or more support devices 14 can
be positioned in the L4-L5 intervertebral space and/or the L5-S1
intervertebral space. The one, two, three or more support devices
14 positioned in the L4-L5 and/or L5-S1 intervertebral spaces, can
mechanically support the adjacent vertebrae and/or fix the adjacent
vertebrae to each other. Bone ingrowth can occur through the
through ports 50, for example fusing the support devices 14 to the
respective surrounding vertebrae.
[0106] FIGS. 29 through 31 illustrate that the transosseous
delivery channel 94 can have a coronal delivery angle 120 measured
to the coronal plane 122, a sagittal delivery angle 124 measured to
the sagittal plane 126, and a transverse delivery angle 128
measured to the transverse plane 130. The coronal delivery angle
120 can be from about 0.degree. to about 25.degree., for example
about 12.degree.. The sagittal delivery angle 124 can be from about
65.degree. to about 90.degree., for example about 75.degree.. The
transverse delivery angle 128 can be from about 0.degree. to about
20.degree., for example about 10.degree.. The support device 14 and
shaft 104 can be configured so the support device 14 can exit the
channel exit port 98 (e.g., directly into the L5-S1 intervertebral
disc) and articulate sufficiently to enter and pass through all or
a significant portion (e.g., more than about 40%, yet more narrowly
more than about 50%, yet more narrowly more than about 75%) of the
width of the L5-S1 intervertebral space.
[0107] FIGS. 30 and 31 show one or both femurs 132 for illustrative
purposes.
[0108] FIGS. 32a through 32d, and separately FIGS. 33a through 33c
illustrate the deployment of the support device 14 into the L5-S1
intervertebral disc space target site, as described for FIGS.
24-27. The support device 14 can be delivered to a complete or
partial discectomy target site 138 in the L5-S1 space.
[0109] FIG. 33d illustrates the shaft 104 can be rotated, as shown
by arrow 134, about the longitudinal axis of the shaft before
during or after the support device 14 is positioned in the L5-S1
intervertebral disc space target site. The support device 14 can
rotate, as shown by arrow 136, in the L5-S1 intervertebral disc
space, for example to control and position the support device 14 to
an angular orientation in the transverse plane 130.
[0110] Any elements described herein as singular can be pluralized
(i.e., anything described as "one" can be more than one). Any
species element of a genus element can have the characteristics or
elements of any other species element of that genus. The
above-described configurations, elements or complete assemblies and
methods and their elements for carrying out the invention, and
variations of aspects of the invention can be combined and modified
with each other in any combination.
* * * * *