U.S. patent application number 12/617526 was filed with the patent office on 2010-08-12 for fixation device and method.
This patent application is currently assigned to STOUT MEDICAL GROUP, L.P.. Invention is credited to E. Skott GREENHALGH.
Application Number | 20100204795 12/617526 |
Document ID | / |
Family ID | 42170336 |
Filed Date | 2010-08-12 |
United States Patent
Application |
20100204795 |
Kind Code |
A1 |
GREENHALGH; E. Skott |
August 12, 2010 |
FIXATION DEVICE AND METHOD
Abstract
An implantable orthopedic stability device is disclosed. The
device can have a contracted and an expanded configuration. A
method of using the device between adjacent facet surfaces for
support and/or fixation of either or both of the adjacent vertebrae
is also disclosed.
Inventors: |
GREENHALGH; E. Skott; (Lower
Gwynedd, PA) |
Correspondence
Address: |
LEVINE BAGADE HAN LLP
2400 GENG ROAD, SUITE 120
PALO ALTO
CA
94303
US
|
Assignee: |
STOUT MEDICAL GROUP, L.P.
Perkasie
PA
|
Family ID: |
42170336 |
Appl. No.: |
12/617526 |
Filed: |
November 12, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61113691 |
Nov 12, 2008 |
|
|
|
Current U.S.
Class: |
623/17.16 |
Current CPC
Class: |
A61F 2002/30515
20130101; A61F 2002/30471 20130101; A61F 2002/30594 20130101; A61F
2002/4677 20130101; A61F 2230/0086 20130101; A61F 2/4405 20130101;
A61F 2002/30522 20130101; A61F 2002/30492 20130101; A61F 2002/4627
20130101; A61F 2310/00023 20130101; A61F 2310/00796 20130101; A61B
17/7064 20130101; A61F 2250/0098 20130101; A61F 2310/00029
20130101; A61F 2002/30387 20130101; A61F 2002/30841 20130101; A61F
2/4611 20130101; A61F 2002/3008 20130101; A61F 2250/0006 20130101;
A61F 2310/00101 20130101; A61F 2/4455 20130101; A61F 2/4425
20130101; A61F 2002/30538 20130101; A61F 2002/30579 20130101; A61F
2002/305 20130101; A61F 2002/30062 20130101; A61F 2220/0091
20130101; A61F 2310/00976 20130101; A61F 2310/00952 20130101; A61F
2310/0097 20130101; A61F 2220/0025 20130101; A61F 2310/00137
20130101; A61F 2210/0004 20130101; A61F 2310/00017 20130101 |
Class at
Publication: |
623/17.16 |
International
Class: |
A61F 2/44 20060101
A61F002/44 |
Claims
1. A method of using an orthopedic support device comprising:
positioning an implantable device between a first facet surface of
a first vertebra and a second facet surface of a second vertebra,
wherein the first vertebra is adjacent to the second vertebra, and
wherein the first facet surface is adjacent to the second facet
surface; and expanding the implantable device between the first
facet surface and the second facet surface.
2. The method of claim 1, further comprising removing some of the
first facet surface.
3. The method of claim 2, further comprising removing some of the
second facet surface.
4. The method of claim 1, wherein positioning further comprises
inserting a flexible leader between the first facet surface and the
second facet surface, and delivering the implantable device on the
leader.
5. The method of claim 4, further comprising removing the leader
from between the first facet surface and the second facet
surface.
6. The method of claim 1, wherein expanding comprises
longitudinally compressing the implantable device.
7. A method of using an orthopedic support device comprising:
positioning an implantable device between a first facet surface of
a first vertebra and a second facet surface of a second vertebra,
wherein the first vertebra is adjacent to the second vertebra, and
wherein the first facet surface is adjacent to the second facet
surface, and wherein the implantable device has a first plate in
contact with the first facet surface and a second plate in contact
with the second facet surface; and fixing the first plate to the
position of the second plate.
8. The method of claim 7, wherein fixing comprises inserting a
third plate between the first plate and the second plate.
9. The method of claim 7, wherein fixing comprises compressing the
first plate and the second plate between the first facet surface
and the second facet surface.
10. The method of claim 7, wherein the
11. An implantable orthopedic device having a longitudinal axis
comprising: a first plate, a second plate, and a third plate,
wherein the first plate has a first panel and a second panel, and
wherein the first panel is extending from a second panel at about a
perpendicular angle to the first panel; and wherein the second
plate has a first panel and a second panel, and wherein the first
panel is extending from a second panel at about a perpendicular
angle to the first panel; and wherein the third plate is located
between the first panel of the first plate and the first panel of
the second plate.
12. The device of claim 11, wherein the third plate comprises a
first unidirectional engaging feature, and wherein the first
unidirectional engaging feature is received by a receiving feature
on the first panel of the first plate.
13. The device of claim 12, wherein the third plate comprises a
second unidirectional engaging feature, and wherein the second
unidirectional engaging feature is received by a receiving feature
on the first panel of the second plate.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Patent
Application No. 61/113,691, filed on Nov. 12, 2008, the content of
which is incorporated herein by reference in its entirety.
BACKGROUND OF THE INVENTION
[0002] 1. Technical Field
[0003] Devices and methods for fixation of tissue are disclosed.
More specifically, the devices and methods can be for inter facet
fusion of vertebrae or fusion of other bones to one another.
[0004] 2. Background of the Art
[0005] Spinal fusion is typically performed by a screw or rod
system with an allograft, Titanium, or PEEK device placed between
vertebral bodies. Facet screws have been used for many years but
have not had favor due to lacking the ability to create bone growth
across the facet joint. A typical facet screw is described in
Sasso, Rick C., et al. "Translaminar Facet Screw Fixation", World
Spine Journal (WSJ). 2006; 1(1):34-39,
<http://www.worldspine.org/Documents/WSJ/1-1/Sasso_TLFS.pdf>
which is incorporated by reference in its entirety.
[0006] A safe and effective facet fusion device alternative to a
facet screw is desired. Furthermore a fusion device that can
promote tissue growth across the facet joint is desired. A device
that can be easily deployed into the facet joint and removed or
repositioned is also desired.
SUMMARY OF THE INVENTION
[0007] A device that can replace or supplement the screw or rod
elements of a typical fusion system is disclosed. The device can be
placed in the inter-facet space to fuse adjacent vertebrae and/or
create a bone mass within the facet joint in a patient's spine. The
device can be placed between adjacent vertebral bodies in the
vetebral body articulating space, for example after a partial or
complete discectomy in place of the removed disc.
[0008] The device can be less invasive than typical existing
devices. For example, the device can be in a compacted (i.e.,
small) configuration when inserted into a patient and transformed
into an expanded (i.e., large) configuration when positioned at the
target site. For example, the device can be expanded when the
device is between the inferior and superior facet surfaces. The
device can create less soft tissue (e.g., bone) disruption than a
typical fusion system. The device in an expanded configuration can
improve anchoring within the joint, structural stability, and
create an environment for bone healing and growth leading to fusion
between adjacent vertebrae.
[0009] The device can have a first plate and a second plate. The
device can be inserted and positioned into the joint so the first
plate is in contact with a first articulating surface of the joint,
and the second plate is in contact with a second articulating
surface of the joint opposite of the first surface of the joint.
For example, the opposite articulating surfaces can be opposed
surfaces of vertebral plates or sides of a facet joint. Once
inserted into the joint, the first plate can be rotatingly tilted
away from the second plate and locked into position. The tilting
and locking of the device can fuse the first articulating joint to
the second articulating joint.
[0010] During deployment into tissue (e.g., bone), one, two or more
holes can be drilled into the target site to create a deployment
hole in which to insert the device. The deployment hole can be
round or non-round (e.g., by drilling more than one overlapping or
adjacent hole, or crafting a square or rectangular hole), for
example to substantially match the transverse cross-section of the
device in a contracted configuration.
[0011] The device can be cannulated, for example having a lateral
(i.e., transverse or latitudinal) and/or lengthwise (i.e.,
longitudinal) channel through the device. The device can be
deployed over a wire or leader, such as a guidewire. The device can
be slid over the guidewire, with the guidewire passing through the
longitudinal channel of the device.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1a is a side perspective view of a variation of the
device in a contracted configuration.
[0013] FIG. 1b is a variation of cross-section A-A of FIG. 1a.
[0014] FIG. 1c is a side perspective view of the device of FIG. 1a
in an expanded configuration.
[0015] FIG. 1d is a variation of cross-section B-B of FIG. 1c.
[0016] FIG. 2a is side view of a variation of cross-section A-A of
FIG. 1a.
[0017] FIG. 2b is side view of a variation of cross-section B-B of
FIG. 1b.
[0018] FIG. 3a is a variation of cross-section A'-A' of FIG.
1a.
[0019] FIG. 3b is a variation of cross-section B'-B' of FIG.
1b.
[0020] FIG. 3c is a variation of FIG. 1a with the top plate
absent.
[0021] FIGS. 4 through 8 illustrate various views and
configurations of a variation of the device.
[0022] FIG. 9 illustrates a partially unassembled variation of the
device.
[0023] FIGS. 10 and 11 illustrate variations of the top and bottom
plates of the device in unassembled and assembled configurations,
respectively.
[0024] FIGS. 12 through 17 illustrate various views of the device
of FIGS. 4 through 8 on a variation of a deployment tool.
[0025] FIG. 18a illustrates a variation of the device in a
contracted configuration.
[0026] FIG. 18b illustrates the device of FIG. 18a in an expanded
configuration.
[0027] FIG. 19a illustrates a variation of the device in a
contracted configuration.
[0028] FIG. 19b illustrates the device of FIG. 19a in an expanded
configuration.
[0029] FIG. 20 illustrates a variation of the device in a
longitudinally expanded configuration.
[0030] FIG. 21 illustrates the device of FIG. 20 is a
longitudinally contracted and radially expanded configuration.
[0031] FIGS. 22 and 23 are transverse sectional views of a
variation of a method for using the device.
[0032] FIGS. 24 through 30 illustrate a variation of a method for
using the device in a section of the spine.
[0033] FIG. 31 illustrates a visualization of a variation of a
method for deploying the device into the spine between adjacent
vertebrae.
[0034] FIGS. 32a and 32b illustrate visualizations of variations of
the device deployed into the spine between adjacent vertebrae.
[0035] FIGS. 33a through 33g illustrate visualizations of a
variation of a method for preparing the target site for the
device.
[0036] FIGS. 34 and 35 illustrate visualizations of variations of
the device inserted in contracted configurations into the
anterior/posterior and lateral bone cavity target sites of the
spine, respectively, to provide facet fusion.
[0037] FIGS. 36 and 37 illustrate anterior/posterior, and lateral
visualizations, respectively, of variations of multiple devices
inserted in expanded configurations in multiple bone cavity target
sites of the spine to provide facet fusion.
DETAILED DESCRIPTION
[0038] A device 1 is disclosed that can be inserted into a target
site 73 with the device 1 in a compressed or contracted (i.e.,
small) configuration. Once positioned in the deployment site, the
device 1 can be transformed into an expanded (i.e., larger, bigger)
configuration. The device 1 can be inserted and expanded in
orthopedic target sites 73 for fixation and/or support. For
example, the device 1 can be inserted and expanded over a guidewire
between adjacent vertebral facet surfaces (i.e., within a facet
joint 55).
[0039] FIGS. 1a through 3c illustrate that the device 1 can have a
top plate 3 attached to a bottom plate 5. The top plate 3 can be
attached to the bottom plate 5 by one, two, three four or more pins
2. The plates can have a substantially flat external surface facing
outward from the device 1. The pin longitudinal axes 13 can be
substantially perpendicular to the plate surface planes of the
external surfaces of the top 3 and bottom 5 plates when the device
1 is in a contracted configuration, and perpendicular to the device
longitudinal axis 77.
[0040] The device 1 can have a middle plate 4 positioned between
the top plate 3 and the bottom plate 5. The middle plate 4 can be
slidably attached to the top plate 3 and the bottom plate 5. The
pins 2 can be in pin slots 11 in the top 3 and/or bottom 5 and/or
middle 4 plates. The pin slots 11 in the middle plate 4 can fix the
pins 2 with respect to the position of the middle plate 4 in the
direction of a device longitudinal axis 77. The pin slots 11 in the
top 3 and bottom 5 plates can allow the pins 2 to move along a
device longitudinal axis 77 with respect to the top 3 and bottom 5
plates to the extent of the pin slots 11, at which point the pin
slots 11 will interference fit against the pins 2 to prevent
further motion of the top 3 and bottom 5 plates. Accordingly, the
top 3 and bottom 5 plates can slide with respect to each other and
to the middle plate 4 in the direction of the device longitudinal
axis 77 (and/or the middle plate 4 longitudinal axis).
[0041] The top plate 3 can have one or more angled and/or curved
ramps 7 on the middle plate 4-side of the top plate 3. The bottom
plate 5 can have one or more angled and/or curved ramped 7 on the
middle plate 4-side of the bottom plate 5. The middle plate 4 can
have angled and/or curved wedges 6 on the top plate 3-side and/or
bottom plate 5-side of the middle plate 4. The wedges 6 can
interface with the ramps 7. For example, the top 3 and bottom 5
plates can be in a contracted, compressed, or otherwise
non-expanded configuration when the middle plate 4 is in a first
position relative to the top 3 and bottom plates 5. The top and/or
bottom 5 plates can be in an expanded, radially spread, or enlarged
configuration when the middle plate 4 is in a second position
(e.g., pulled away 9) relative to the top and/or bottom 5
plates.
[0042] The middle plate 4 can have no, one or two side walls 10.
The side walls 10 can extend to about the height of the top plate 3
and/or bottom plate 5 when the device 1 is in a contracted or
expanded configuration.
[0043] The top plate 3, bottom plate 5, side plates and
combinations thereof can have ingrowth channels 12, windows, or
ports. The ingrowth channels 12 can be configured to encourage bone
growth into the ingrowth channel. For example, the ingrowth
channels 12 can have textured surface and/or be coated and/or
partially or completely filled with one or more osteogenic or
osteoinductive material, for example any of those disclosed
below.
[0044] FIGS. 3a and 3b illustrate that the pins 2 can be contained
by the top 3 and bottom 5 plates during expansion 41 of the device
1. The pins 2 can be radiopaque and/or anti-torque. The side walls
10 can brace or otherwise interference fit the top and/or bottom 5
plates, for example to minimize lateral movement of the top and/or
bottom 5 plates relative to the middle plate 4.
[0045] When the device 1 is in an expanded configuration, the top
plate surface plane 15 and the bottom plate surface plane 29 can
rotate away from each other, as shown by arrow 8, to form a device
expansion angle 14. The device expansion angle 14 can be from about
1.degree. to about 45.degree., more narrowly from about 2.degree.
to about 20.degree.. For example, the device expansion angle 14 can
be about 5.degree. or about 10.degree.. The device 1 can have a
ratchet, or steps or teeth on the ramp 7 and wedges 6 to allow the
device expansion angle 14 to be expanded at discrete increments,
such as increased at increments of about 0.25.degree., about
0.5.degree., about 1.degree., or about 2.degree..
[0046] FIGS. 4 through 8 illustrate that the top and/or bottom 5
plates can have inner panels that are adjacent to and oppose each
other. The top and/or bottom 5 plates can have respective
deployment stop panels and/or wing panels (25, 28). The deployment
stop panels can extend at substantially perpendicular angles (e.g.,
from about 80.degree. to about 100.degree., for example about
90.degree.) from the inner panels. The wing panels (25, 28) can
extend at angles from the ends of the deployment stop panels away
from the side of the inner panels. For example, the wing panels
(25, 28) can extend from the deployment stop panels at about
0.degree. to about 60.degree., more narrowly from about 5.degree.
to about 45.degree., for example about 30.degree..
[0047] During use, the deployment stop panels and/or the wing
panels (25, 28) can interference fit against the outside of the
bone (e.g., the facet) to prevent overinsertion or misplacement of
the device 1 into the target site 73. The deployment stop panels
and/or wing panels (25, 28) can contact the facets and/or vertebral
body side wall when implaned in the vertebral body disc space. The
deployment stop panels and/or wing panels (25, 28) can abut and
interference fit against the bone outside of the joint of the
target site 73 to prevent the device 1 from being inserted too far
into the joint space. Additional anchoring elements, such as drive
screws, can be inserted through the deployment stop panel and/or
wing panel (25, 28) and the adjacent tissue (e.g., into the
vertebral side wall and or facet) before, during or after the
device 1 is expanded to fix the device 1 to the target site 73. The
device 1 can be retrieved or repositioned, for example, by grabbing
and pulling on the deployment stop panel and/or wing panel (25,
28).
[0048] The top plate 3 and/or bottom plate 5 can have surface
texturing, for example coring or gripping teeth on the
outward-facing surface of the inner panels. The top and/or bottom 5
plates can have ramps 7 and/or slots 21 and tabs 18. The ramps 7
can be on the inward-facing surfaces of the tabs. The tabs can be
partially bendable away from the plane of the inner panel. For
example, as shown in FIG. 6, when the wedges 6 of the middle plate
4 are received by the ramps 7 of the inner panels, the wedges 6 can
push the tabs outwardly to extend from the plane of the inner
panels. During use, the extended tabs can interference fit against
the surrounding tissue (e.g., bone).
[0049] The top plate 3 and/or bottom plate 5 can have a stop seat
20 formed into the top and/or bottom plate 5 along the outer
surface of the deployment stop panels. The stop seat 20 can be
recessed into the deployment stoop panels. The stop seat 20 can be
configured to receive a middle stop plate on the middle plate 4. As
shown in FIG. 6, when the middle plate 4 is fully inserted between
the top plate 3 and the bottom plate 5, the middle stop plate can
lie flush in the stop seat 20.
[0050] The top and/or bottom 5 plates can have grooves formed along
the inner-surface of the inner panels extending to the top plates.
The grooves can form slots 21 when the top plate 3 and bottom plate
5 are adjacent to each other.
[0051] The middle plate 4 can have one or more rails 16. The rails
16 can be on opposite sides of the middle plate 4. The rails 16 can
extend along the length of the middle plate 4. The rails 16 can be
configured to insert and slide through the slots 21 formed in the
top and/or bottom 5 plates. The leading edge of the rail 16 can be
angled, for example to a point or angled but with a flat front
surface (as shown).
[0052] The rails 16 can have one or more wedges 6. For example,
each rail 16 can have two wedges 6 on the side of the rail 16
facing the top plate 3 and two wedges 6 on the side of the rail 16
facing the bottom plate 5. The rails 16 can be spaced
longitudinally along the rail 16.
[0053] The middle plate 4 can have one or more ingrowth channels
12. For example, the ingrowth channels 12 on the middle plate 4 can
be arranged in a grid of two by three ingrowth channels 12. The
ingrowth channels 12 can be located between opposing rails 16.
[0054] The middle plate 4 can be inserted between the top 3 and
bottom 5 plates. The middle plate 4 can be inserted along the
length of the space between the top inner panel 26 and bottom inner
panel 23 until the middle plate stop 19 interference fits against
the stop seat 20. The top-bottom plate gap 24 can expand, for
example up to about 100% or, more narrowly, up to about 50% from
the contracted top-bottom plate gap 24.
[0055] FIG. 8 illustrates that the taps can be pushed outward by
the wedges 6 and/or the top 3 and bottom 5 plates can have ports in
place of the tabs. The wedges 6 from the middle plate 4 can extend
into or out of the outer side of the ports (accordingly, the wedges
6 would be the tabs as labeled in FIG. 8).
[0056] The inner surface of the top inner panel 26 and the inner
surface of the bottom inner panel 23 can form substantially equal
device expansion angles 14 whether the device 1 is in an expanded
(i.e., top 3 and bottom 5 plates apart) or contracted (i.e., top 3
and bottom 5 plates together) configuration.
[0057] The device 1 can have no pins or pin slots.
[0058] FIG. 9 illustrates that the rails 16 on the middle plate 4
can have one or more rail extensions 30. For example, each rail 16
can have inwardly extending rail extensions 30 along the length of
the rails 16 on one or both sides of the middle plate 4 facing the
inner panels. The slots 21 can have slot extensions 31. For
example, each slot 21 can have a slot extension 31 corresponding to
the rail extensions 30 on the middle plate 4. The slots 21 can be
t-slots. The rail extensions 30 can be configured to be slidably
received by the slot extensions 31.
[0059] FIGS. 10 and 11 illustrate that the bottom plate 5 (as
shown) and/or top plate 3 can have one or more tabs extending in
the direction of the top plate 3. The tabs can extend from the
deployment stop panels, in the plane of the deployment stop panels,
pointed toward the opposing deployment stop panel. The tabs can
have tab ends 34 at the termini of the tabs. The tab ends 34 can
have a locking feature, such as a flared end, brads, and expanded
radius, or combinations thereof.
[0060] The top plate 3 can have one or more tab slots 33,
corresponding to the positions, shapes, and sizes of the tabs. The
tab slots 33 can be configured to receive the tabs. The tab slots
33 can have tab windows 32. The tab windows 32 can be configured to
receive the tab ends 34, for example the locking feature of the tab
ends 34. The tab windows 32 can be open to the surface of the
corresponding panel in which the tab end 34 is located.
[0061] When the top plate 3 and bottom plate 5 are pressed toward
each other, as shown by arrows in FIG. 11, the tabs 18 can be
slidably received by the tab slots 33. The tab ends 34 can
releasably lock into the tab windows 32. The tab windows 32 can be
visually inspected to insure the tab end 34 is present, for
example, as an indicator that the bottom plate 5 is fully engaged
with, and fixedly attached to, the top plate 3.
[0062] FIGS. 12 through 16 illustrate that the device 1 can be
removably attached to a deployment tool 35. The deployment tool 35
can provide a proximally retracting force (a "pull" deployment) or
distally extending force (a "push" deployment) against the device 1
to expand and/or lock the device 1 depending on the design of the
device 1 and the deployment tool 35.
[0063] The deployment tool 35 can have a deployment tool case 36.
The deployment tool 35 can have grasping fingers 37 extending from
the distal end of the deployment tool case 36. The grasping fingers
37 can be extended distally away from the deployment tool case 36,
radially expanding from the other grasping fingers 37 and releasing
the device 1. The grasping fingers 37 can be retracted proximally
toward the distal end of the deployment tool case 36, radially
contracting toward the other grasping fingers 37 and compressing
against and holding the device 1.
[0064] Two grasping fingers 37 can releasably attach on opposite
sides of the top plate 3, for example against the surface of the
top deployment stop panel 27 facing the top inner panel 26. Two
grasping fingers 37 can releasably attach on opposite sides of the
bottom plate 5, for example against the surface of the bottom
deployment stop panel 22 facing the bottom inner panel 23. The
middle plate 4 can be aligned with the slots 21.
[0065] FIG. 17 illustrates that the deployment tool 35 can have an
anvil 38. The anvil 38 can hold the middle plate 4 in place, which
can transmit the force to the top 3 and bottom 5 plates, holding
the top 3 and bottom 5 plates in compression against the grasping
fingers 37, as shown in FIGS. 12 through 16. Once the device 1 is
placed into a target site 73 (e.g., within a facet joint 55), the
anvil 38 can be translated, as shown by arrow, to force the middle
plate 4 between the top plate 3 and the bottom plate 5. The device
1 can be expanded. The tabs and/or wedges 6 can then interference
fit to prevent the middle plate 4 from retreating and the middle
plate 4 can be fixedly attached to the top 3 and bottom 5 plates.
The grasping fingers 37 can be extended from the deployment tool
case 36, radially expand away from one another, and release the
device 1. The anvil 38 can be withdrawn into the deployment tool
case 36.
[0066] FIGS. 18a and 18b illustrate that the device 1 can have
cells 39 or pores. The cells 39 can be open when the device 1 is in
a contracted configuration and/or open when the device 1 is in an
expanded configuration so material can pass through the cells 39 to
an inner longitudinal channel or lumen inside of the device 1,
and/or to the opposite side of the device 1. For example, bone or
other tissue growth can occur through the cells 39. The bone growth
can pass through and encompass the device 1.
[0067] The device 1 can have a round or circular transverse
cross-section. The device 1 can be ductile or deformable. The
device 1 can be resilient.
[0068] FIG. 18a illustrates the device 1 can be loaded on a mandrel
40 or deployment tool 35 in a contracted configuration. FIG. 18b
illustrates that a first end of the device 1 can be radially
expanded by the mandrel 40 or other deployment tool 35 while the
second end of the device 1 can remain contracted.
[0069] FIGS. 19a and 19b illustrate that the device 1 can have
insubstantial pores or cells 39. For example, substantially no
material can flow or otherwise pass through the cells 39 or pores
of the device 1.
[0070] FIG. 20 illustrates that the top plate 3 can be rotatably
attached to the bottom plate 5. The top plate 3 and the bottom
plate 5 can be integral with or attached to a plate hinge 44. The
top plate 3 and bottom plate 5 can be attached at a first end at
the plate hinge 44. The top plate 3 and bottom plate 5 can be
unattached at a second end away from the plate hinge 44.
[0071] The top plate 3 and/or bottom plate 5 can have a surface
texture 17 on the outward-facing surface. For example, the surface
texture 17 can be ribs 43 oriented along the longitudinal axis of
the device 1.
[0072] The top plate 3 and bottom plate 5 can form a side port 46.
The middle plate 4 can be slidably received by the side port 46.
The middle plate 4 can have a side wall 10. The side wall 10 can
obstruct, cover, and/or seal the external side of the side port
46.
[0073] The middle plate 4 can have a middle plate port 47. The
plate hinge 44 can have a plate hinge port 45. The middle plate
port 47 and the plate hinge port 45 can be aligned along the
longitudinal axis of the device 1. A deployment tool 35 can be
releasably attached to the middle plate port 47 and/or the plate
hinge port 45. The deployment tool 35 can compress the middle plate
port 47 toward the plate hinge port 45.
[0074] The middle plate 4 can have one or more middle plate ramps
48, for example positioned adjacent to the inner surfaces of the
top plate 3 and the bottom plate 5. When the middle plate 4 is
longitudinally extended away from the top 3 and bottom 5 plates, as
shown in FIG. 20, the plane of the top plate 3 can be can be
substantially parallel to the plane of the bottom plate 5.
[0075] FIG. 21 illustrates that the middle plate 4 can be
translated toward the plate hinge 44. For example, a deployment
tool 35 can exert a compression force on the plate hinge 44 and the
middle plate 4, translating the middle plate 4 toward the middle
plate ramp 48, as shown by arrow 50. The top plate ramps can
rotate, as shown by arrows 49, the top plate 3 away from the bottom
plate 5.
[0076] The device 1 can have one or more radiopaque and/or
echogenic markers 51. For example, the device 1 can have aligned
markers 51 on the top plate 3, middle plate 4 and bottom plate 5.
When the device 1 is in a contracted pre-deployment configuration,
the markers 51 can be located immediately adjacent to one another,
for example appearing as a single marker 51. When the device 1 is
in an expanded configuration, the markers 51 can move apart from
each other, indicating to a doctor performing the implantation and
deployment procedure using visualization (e.g., x-ray or
ultrasound-based) that the device 1 has expanded. Under
visualization the markers 51 can also indicate the location and
orientation of the device 1.
Method of Using
[0077] The cartilage can be partially, substantially or completely
removed from the inter facet joint. A three-dimensional cavity
shape can be formed into the facet surfaces, for example to improve
stability and fusion of the device 1 when the device 1 is
implanted. A bone removal tool can be used on the facet surfaces
prior to the insertion of the implant to remove and shape bone
and/or other tissue. The bone removal tool can be cannulated and
have guides to assure proper depth and orientation within the facet
joint 55 space. The bone removal tool (which can also remove
cartilage and other tissue) can be round or non-round. The bone
removal tool can be shaped to match the shape profile of the
unexpanded implant.
[0078] FIG. 22 illustrates that the device 1 can be inserted along
the implant pathway 54 into the target site 73, such as between the
superior articular process 53 and inferior articular process 56 of
a facet joint 55. The device 1 can be inserted into the facet joint
55 without protruding into the vertebral foramen 57. (The spinous
process 52 is shown as a landmark for illustrative purposes.) The
device 1 can be partially or completely radially expanded before or
after inserting the device 1 into the target site 73. An expanded
bone cavity 68 can optionally be drilled into the facet joint 55
before insertion of the device 1 in which the device 1 can be
inserted.
[0079] FIG. 23 illustrates that the device 1 can then be expanded,
as shown by arrows, and held in place by an interference or
friction fit within the bone cavity 68 in the facet joint 55.
Regular spinal loads, such as compression of the facet joint 55,
can provide additional anchoring and settling (i.e., stop
migration) of the device 1. The device 1 can expand into a reverse
taper, as shown in FIG. 22. For example, the end of the device 1
closer to the vertebral foramen 57 can eapnd to a larger radius
than the end of the device 1 further from the vertebral foramen
57.
[0080] The devices 1 can be made from PEEK, any medical grade
polymer or metal, or any other material disclosed herein. The
device 1 can be coated, for example with bone morphogenic protein
(BMP), ceramic, and/or any other material disclosed herein.
[0081] FIGS. 24 through 30 illustrate a variation of the location
of the device 1 and the fusion location when this device 1 is
deployed in use. The device 1 can be deployed less (e.g.,
minimally) invasively, over the wire 66, percutaneously, used with
a vertebral body replacement or fusion cage, or combinations
thereof. The device 1 can be expandable and un-expandable for
removal or repositioning.
[0082] FIG. 24 illustrates that a first vertebra 84 can have a
first facet surface 86. A second vertebra 85 can be adjacent to the
first vertebra 84. The second vertebra 85 can have a second facet
surface 87 adjacent to the first facet surface 86. An implant
pathway 54 for the device 1 can be substantially parallel with the
first 86 and second 87 facet surfaces. The device 1 can be pushed
into the space between the first 86 and second 87 facet
surfaces.
[0083] FIG. 25 illustrates that the implant angle can minimize the
needle or punch from damaging the spinal cord. The spinal cord is
protected by the vertebral arch (lamina) just below the inferior
articular process 56 of the facet joint 55. The spine 62 can have a
spinal longitudinal axis 61. The implant pathway 54 in the sagittal
plane measured from the coronal 63 side of the longitudinal axis
can have a sagittal implant pathway angle 60. The sagittal implant
pathway 54 angle can be from about 40.degree. to about 110.degree.,
for example about 60.degree..
[0084] FIG. 26 illustrates that during spinal flexion or extension,
as shown by arrows 64, the articular facet surfaces can experience
shear forces 65 relative to each other. The device 1 can be
oriented perpendicular to the shear motion, for example with the
plane of the surface of the inner panels aligned with the shear
forces 65.
[0085] FIGS. 27 (and 33b, 33c and 33d) illustrates that a wire 66
can be inserted between the articular processes. The wire 66 can be
a guidewire, lead, catheter, or combinations thereof. The wire 66
can be placed along the implant pathway 54. Deployment tools 35
and/or the device 1 can be inserted along the wire 66. The wire 66
can be removed after positioning, expansion 41, or at any other
time during deployment of the device 1 or deployment tools 35. The
vertebral arch (lamina) can be stop the wire 66 (and device 1)
insertion, for example, protecting the spinal cord and nerves.
[0086] FIGS. 28 (and 33e, 33f and 33g) illustrate that a bone
cavity 68 can be created. The bone shaping and removal can be
performed with a drill 67 or other bone removal tool. The drill 67
can slide over and follow the wire 66 to the outer surface of the
facet articular surface. The drill 67 can have a guide to orient
the drill 67 with a cutting plane. The cutting plane can be the
space between the inferior and superior articular process 53 of the
articular surfaces and sharp edges, for example the plain of the
articular processes 69, as shown in FIG. 28. The drill 67 can cut,
shape and remove tissue, such as bone and/or cartilage. The
creation of the bone cavity 68 can create a bloody bone surface to
aid in regrowth and fusing of the bones on which the cavity was
created.
[0087] FIGS. 29 (and 31) illustrates that the device 1 can be
removably attached to a delivery system or deployment tool 35. The
deployment tool 35 can insert the device 1 into the target site 73.
For example the deployment tool 35 can be pushed over the wire 66
as shown by arrow.
[0088] The device 1 can be positioned such that the first plate is
against the first facet surface 86 and the second plate is against
the second facet surface 87. For example, the inner panels can be
against the facet surfaces. Teeth or texturing on the panels and/or
plates can be pressed against the facet surfaces and frictionally
resist withdrawal from the deployed position. The stop panels
and/or wing panels (25, 28) can abut bone and/or other tissue and
stop insertion of the device 1 into the target site 73.
[0089] The opposed facet surfaces can compress against the device
1, for example, releasably fixing the device 1 in the facet joint
55.
[0090] When the device 1 is positioned as desired (e.g., into the
drilled bone cavity 68 and/or between unaltered surfaces forming
the facet joint 55) and expanded and/or locked, the deployment tool
35 can then release the device 1. The device 1 can lock itself into
place with outward expansion, wedging, or interference force when
receiving a release force from the deployment tool 35 or
otherwise.
[0091] FIG. 30 illustrates that the device 1 can be expanded
between the first and second articular process facet surfaces. The
device 1 can resist the shear forces shown in FIG. 26. The adjacent
articular facet surfaces can regrow through and around the device 1
and fuse to each other (for example, with the cartilage
removed).
[0092] FIG. 31 illustrates the deployment tool 35 inserted to a
target site 73 in vivo between a first vertebra 84 and a second
vertebra 85. For example, the device 1 can be placed at the target
site 73 after a partial or complete discectomy. When the device 1
is in a contracted configuration, the tool can position the device
1 between a first vertebral body 92 of the first vertebra 84 and a
second vertebral body 93 of the second vertebra 85. The device 1
can be inserted into the target site 73 a direction substantially
parallel to the surfaces of the vertebral body end plates. The
device 1 can be placed between a first vertebral end plate 90 of
the first vertebral body 92 and the adjacent second vertebral end
plate 91 of the second vertebral body 93. In this inter-vertebral
location, the top plate 3 of the device 1 can be in contact with or
directly adjacent to the first vertebral end plate 90. The bottom
plate 5 of the device 1 can be in contact with or directly adjacent
to the second vertebral end plate 91.
[0093] FIGS. 32a and 32b illustrate that the deployment tool 35 can
radially expand the device 1 between the first vertebral end plate
90 and the second vertebral end plate 91. The top plate 3 can press
against and/or embed into the first vertebral end plate 90. The
bottom plate 5 can press against and/or embed into the second
vertebral end plate 91. The device 1 can fuse the first vertebra 84
to the second vertebra 85.
[0094] The device 1 can be filled with a filled before or after
radial expansion. Tissue ingrowth can occur into the top plate 3
through the top ports 42, bottom plate 5 through the bottom ports,
and elsewhere through the device 1.
[0095] FIGS. 33a through 33g illustrate visualizations of a
variation of a method for preparing the target site 73 for the
device 1. FIG. 33a illustrate a visualization of the spine 62 with
the target site 73 identified, such as a facet joint 55. FIGS. 33b
and 33c illustrates that a leader or wire 66, such as a guidewire,
can be inserted or otherwise deployed into the target site 73, for
example, the wire 66 can be percutaneously inserted in a minimally
invasive procedure. The wire 66 can be inserted into the facet
articular space, for example between the first facet surface 86 and
the adjacent second facet surface 87. The wire 66 can be anteriorly
and/or posteriorly inserted, as shown in FIG. 33b. The 33c
illustrates that the wire 74 can be laterally inserted.
[0096] FIG. 33d illustrates that a first wire 88 can be inserted
into the first facet joint 82. A second wire 89 can be inserted
into the second facet joint 83. The first wire 88 can be inserted
in an anteriorly/posteriorly direction, or a lateral direction. The
second wire 89 can be inserted in an anteriorly/posteriorly
direction, or a lateral direction.
[0097] FIGS. 33e and 33f illustrate that the drill 67 can be
inserted, as shown by arrow, over the wire to the target site 73,
such as the pedicles 75. The drill 67 can then be used to drill
away a portion of the bone 76, for example, creating a bone cavity
68 as shown in FIG. 33g for insertion of the device 1.
[0098] FIGS. 34 and 35 illustrate visualizations of variations of
the device 1 inserted in contracted configurations into the
anterior/posterior and lateral bone cavity 68 target sites 73 of
the spine 62, respectively, to provide facet fusion. The devices 1
can have radiopaque and/or echogenic visualization markers 51, for
example the markers 51 can be along the top plate 3, bottom plate
5, and one or more panels of the plates. The first and/or second
deployment tools 80 and 81 can also have one or more markers 51.
The devices 1 can be inserted into multiple facet bone cavity 68
target sites 73 of the spine 62 to provide facet fusion. A first
device 78 can be inserted into a first facet joint 82 and a second
device 79 can be inserted into a second facet joint 83. The first
78 and second 79 devices can be inserted bilaterally, for example
both devices can be inserted between the same first vertebra 84 and
second vertebra 85 on opposite lateral sides. FIGS. 36 and 37
illustrate visualizations of variations of the devices 1 in
expanded configurations in multiple facet bone cavity 68 target
sites 73 of the spine 62 to provide facet fusion. The first device
78 and second device 79 can be expanded in the first facet joint 82
and the second device 79 can be inserted in the second facet joint
83.
[0099] Because FIGS. 35 and 37 are lateral views, the facet joints
are substantially viewed at the same location and are not
substantially distinguishable in the view.
[0100] Any or all elements of the device 1 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.), poly
ester amide (PEA), polypropylene, aromatic polyesters, such as
liquid crystal polymers (e.g., Vectran, from Kuraray Co., Ltd.,
Tokyo, Japan), ultra high molecular weight polyethylene (i.e.,
extended chain, high-modulus or high-performance polyethylene)
fiber and/or yarn (e.g., SPECTRA.RTM. Fiber and SPECTRA.RTM. Guard,
from Honeywell International, Inc., Morris Township, N.J., or
DYNEEMA.RTM. from Royal DSM N.V., Heerlen, the Netherlands),
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), poly-L-glycolic acid (PLGA), polylactic
acid (PLA), poly-L-lactic acid (PLLA), 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.
[0101] The device 1 can be made from substantially 100% PEEK,
substantially 100% titanium or titanium alloy, or combinations
thereof.
[0102] Any or all elements of the device 1 and/or other devices or
apparatuses described herein, can be, have, and/or be completely or
partially coated with agents for cell ingrowth.
[0103] The device 1 and/or elements of the device 1 and/or other
devices or apparatuses described herein can be filled, coated,
layered and/or otherwise made with and/or from cements, fillers 70,
and/or glues known to one having ordinary skill in the art and/or a
therapeutic and/or diagnostic agent. Any of these cements and/or
fillers 70 and/or glues can be osteogenic and osteoinductive growth
factors.
[0104] Examples of such cements and/or fillers 70 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.
[0105] 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.
[0106] 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.
* * * * *
References