U.S. patent application number 13/669294 was filed with the patent office on 2013-05-16 for devices and methods for the minimally invasive treatment of spinal stenosis.
The applicant listed for this patent is SAMY ABDOU. Invention is credited to SAMY ABDOU.
Application Number | 20130123849 13/669294 |
Document ID | / |
Family ID | 38982113 |
Filed Date | 2013-05-16 |
United States Patent
Application |
20130123849 |
Kind Code |
A1 |
ABDOU; SAMY |
May 16, 2013 |
DEVICES AND METHODS FOR THE MINIMALLY INVASIVE TREATMENT OF SPINAL
STENOSIS
Abstract
Multiple implants and methods for the minimally invasive
treatment of spinal stenosis are disclosed. A spinal implant device
includes a spacer region and an attachment region. The spacer
region is adapted to be positioned between first and second spinous
processes of first and second vertebral bodies to limit movement of
the first spinous process and the second spinous process toward one
another. The attachment region attaches to the first spinous
process via a fastener that extends substantially along a long axis
of the spinous process.
Inventors: |
ABDOU; SAMY; (San Diego,
CA) |
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Applicant: |
Name |
City |
State |
Country |
Type |
ABDOU; SAMY |
San Diego |
CA |
US |
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|
Family ID: |
38982113 |
Appl. No.: |
13/669294 |
Filed: |
November 5, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11881584 |
Jul 27, 2007 |
8303630 |
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13669294 |
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60834209 |
Jul 27, 2006 |
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60834003 |
Jul 28, 2006 |
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60860942 |
Nov 24, 2006 |
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Current U.S.
Class: |
606/248 ;
606/86A |
Current CPC
Class: |
A61F 2002/3085 20130101;
A61F 2002/30754 20130101; A61F 2/28 20130101; A61F 2/30744
20130101; A61F 2002/2835 20130101; A61F 2/4405 20130101; A61B
17/7067 20130101; A61F 2310/00796 20130101; A61F 2002/30841
20130101; A61F 2002/3092 20130101; A61F 2310/00976 20130101; A61F
2002/30131 20130101; A61F 2230/0013 20130101; A61F 2002/30622
20130101; A61B 17/7062 20130101; A61B 17/7064 20130101; A61B 17/86
20130101; A61B 2017/0256 20130101; A61B 17/7065 20130101; A61F
2002/3084 20130101 |
Class at
Publication: |
606/248 ;
606/86.A |
International
Class: |
A61B 17/70 20060101
A61B017/70 |
Claims
1.-10. (canceled)
11. An orthopedic device, comprising: a first member configured to
attach onto at least one first vertebra and limit motion of said
first vertebra relative to a second, adjacent vertebra; wherein
said first member defines a substantially curvilinear motion
pathway of said first vertebra having at least one center of
rotation near a natural instantaneous axis of rotation between said
first vertebra and said second vertebra; and wherein said first
member is configured to provide limited relative motion between
said first vertebra and said second vertebra such that said
relative motion is greater in flexion than in extension.
12. The device of claim 11, wherein said first member is configured
to attach onto at least one spinous process of said first
vertebra.
13. An assembly for placement of an orthopedic implant within a
target inter-spinous space of a spinal column, said assembly
comprising: an implant placement device comprising: at least a
first extension member and a second extension member, each of said
first and second extension members comprising an elongated segment
configured to extend from a proximal aspect to a distal aspect, and
each of said first and second extension members configured to be
positioned within said target inter-spinous space at said distal
aspect thereof; and a distraction mechanism configured to connect
to said proximal aspect of each of said first and said second
extension members, and to forcibly move said first extension member
relative to said second extension member, said movement configured
to produce at least some expansion of said target inter-spinous
space; a guide channel formed at least in part by a bore configured
to extend from a proximal opening to distal opening in between said
first and second extension members; and an orthopedic implant
configured to be advanced at least partially through said guide
channel and be positioned within said target inter-spinous space;
wherein said first and second extension members are removed from
said target inter-spinous space, yet said orthopedic implant
remains positioned within said inter-spinous space to maintain
first and second vertebral bones of said spinal column separated by
a desired distance.
14. The assembly of claim 13, wherein a surface of said first
extension member is configured to form at least a portion of said
guide channel used for orthopedic implant placement.
15. The assembly of claim 13, wherein a surface of said second
extension member is configured to form at least a portion of said
guide channel used for orthopedic implant placement.
16. The assembly of claim 13, wherein said first extension member
extends away from said distraction mechanism along a curvilinear
trajectory.
17. The assembly of claim 13, wherein said second extension member
extends away from said distraction mechanism along a curvilinear
trajectory.
18. The assembly of claim 13, wherein said guide channel extends
from a proximal end to a distal end along a curvilinear
trajectory.
19. The assembly of claim 13, further comprising an elongated
member configured to be slidably positioned within said guide
channel during advancement of said first and second extension
members towards said target inter-spinous space, said elongated
member being shaped to separate tissues ahead of said advancing
first and second extension members.
20. The assembly of claim 19, wherein said elongated member is
configured to be removed from between said first and second
extension members prior to advancement of said orthopedic implant
through said guide channel.
21. The assembly of claim 13, wherein said orthopedic implant
comprises at least two segments configured to be movable relative
to one another.
22. The assembly of claim 13, wherein said orthopedic implant is
adapted to transition from a first size to a second, larger size
after advancement into said target inter-spinous space.
23. An assembly for placement or an orthopedic implant within a
target inter-spinous space of a spinal column, said assembly
comprising: an implant placement device comprising: at least a
first extension member and a second extension member each of said
first and second extension members comprising an elongated segment
configured to extend from a proximal aspect to a distal aspect and
each of said first and second extension members configured to be
positioned within said target inter-spinous space at said distal
aspect thereof; and a distraction mechanism configured to connect
to said proximal aspect of each of said first and said second
extension members, and to forcibly move said first extension member
relative to said second extension member said movement configured
to produce at least some expansion of said target inter-spinous
space, said first and second extension members thereby creating a
guide channel therebetween; an elongated member configured to be
slidably positioned within said guide channel during advancement of
said first and second extension members towards said target
inter-spinous space, said elongated member being shaped to separate
tissues ahead of said advancing first and second extension members;
and an orthopedic implant configured to be advanced at least
partially through said guide channel and be positioned within said
target inter-spinous space; wherein said elongated member is
configured to be removed prior to advancement of said orthopedic
implant through said guide channel; and wherein said first and
second extension members are configured to be removed from said
target inter-spinous space after said advancement of said
orthopedic implant.
24. The assembly of claim 23, wherein said implant placement device
further comprises an actuatable mechanism configured to couple to a
proximal segment of each of said first and second extension
members, and to reversibly change a distance between said first and
second extension members and thus a size of said guide channel.
25. The assembly of claim 24, wherein actuation of said actuatable
mechanism produces at least some movement of a spinous process of a
first vertebral bone relative to a spinous process of a second
vertebral bone, said target inter-spinous space being located
between said first and second vertebral bones.
26. The assembly of claim 24, wherein said implant placement device
further comprises an indicia of a value of a distraction force
delivered to said first and second extension members by said
actuatable mechanism.
27. The assembly of claim 24, wherein said implant placement device
further comprises an indicia of a distance between said first and
second extension members.
28. The assembly of claim 24, wherein said implant placement device
further comprises an indicia of a size of an implant appropriate
for placement into said target inter-spinous space.
29. The assembly of claim 23, wherein said guide channel is formed
at least in part by a surface of said first extension member or a
surface of said second extension member.
30. The assembly of claim 23, wherein said orthopedic implant
further comprises at least two segments configured to move relative
to one another.
31. The assembly of claim 23, wherein said orthopedic implant is
configured to expand in size after advancement into said target
inter-spinous space.
Description
REFERENCE TO PRIORITY DOCUMENTS
[0001] This application is a continuation of and claims priority to
co-pending U.S. patent application Ser. No. 11/881,584 issuing as
U.S. Pat. No. 8,303,630 on Nov. 6, 2012, which is incorporated
herein by reference in its entirety, and which claims priority of
the following co-pending U.S. Provisional Patent Applications: (1)
U.S. Provisional Patent Application Ser. No. 60/834,209, filed Jul.
27, 2006; (2) U.S. Provisional Patent Application Ser. No.
60/834,003, filed Jul. 28, 2006; (3) U.S. Provisional Patent
Application Ser. No. 60/860,942, filed Nov. 24, 2006. Priority of
the aforementioned filing dates is hereby claimed. The disclosures
of the Non-provisional and Provisional Patent Applications are
hereby incorporated by reference in their entirety.
BACKGROUND
[0002] The present disclosure is related to orthopedic devices
implanted between skeletal segments. The implanted devices are used
to adjust and maintain the spatial relationship(s) of adjacent
bones. Depending on the implant design, the motion between the
skeletal segments may be returned to normal, increased, modified,
limited or completely immobilized.
[0003] Progressive constriction of the central canal within the
spinal column is a predictable consequence of aging. As the spinal
canal narrows, the nerve elements that reside within it become
progressively more crowded. Eventually, the canal dimensions become
sufficiently small so as to significantly compress the nerve
elements and produce pain, weakness, sensory changes, clumsiness
and other manifestation of nervous system dysfunction.
[0004] Constriction of the canal within the lumbar spine is termed
lumbar stenosis. This condition is very common in the elderly and
causes a significant proportion of the low back pain, lower
extremity pain, lower extremity weakness, limitation of mobility
and the high disability rates that afflict this age group.
[0005] The traditional treatment for this condition has been
laminectomy, which is the surgical removal of the lamina portion of
bone and the adjacent ligamentous structures that constrict the
spinal canal. Despite advances in surgical technique, spinal
decompression surgery can be an extensive operation with risks of
complication from the actual surgical procedure and the general
anesthetic that is required to perform it. Since many of these
elderly patients are in frail health, the risk of developing
significant peri-operative medical problems remains high. In
addition, the surgical resection of spinal structures may relieve
the neural compression but lead to spinal instability in a
substantial minority of patients. That is, removal of the spinal
elements that compress the nerves may weaken the vertebral column
and lead to spinal instability and vertebral mal-alignment. With
instability, the vertebrae will move in an abnormal fashion
relative to one another and produce pain, nerve re-impingement,
weakness and disability. Further, re-stabilization of the spinal
column requires additional and even more extensive surgery. Because
of these issues, elderly patients with lumbar stenosis must often
choose between living the remaining years in significant pain or
enduring the potential life-threatening complications of open
spinal decompression surgery.
[0006] Recently, lumbar stenosis has been treated by the
distraction--instead of resection--of those tissues that compress
the spinal canal. In this approach, an implantable device is placed
between the spinous processes of the vertebral bodies at the
stenotic level in order to limit the extent of bone contact during
spinal extension. Since encroachment upon the nerve elements occurs
most commonly and severely in extension, this treatment strategy
produces an effective increase in the size of the spinal canal by
limiting the amount of spinal extension. In effect, the distraction
of the spinous processes changes the local bony anatomy and
decompress the nerves at the distracted level by placing the spinal
segment into slight flexion.
[0007] Unfortunately, the placement of a conventional inter-spinous
implant requires surgical exposure of the posterior and lateral
aspects of the spinous processes as well as the posterior aspect of
the spinal column. Since these operations still carry a significant
risk of peri-operative complications in the elderly, there remains
a need in the field for devices and methods that reduce the scope
of the surgical procedure and its inherent risks.
SUMMARY
[0008] This application discloses a series of novel devices and
methods for the minimally invasive treatment of spinal stenosis. In
an embodiment, distraction members are percutaneously placed into
the space between two adjacent spinous processes. The distraction
members are attached to a distraction platform and the platform is
configured to adjustably distract and set the distance between the
distraction members. With actuation of the distraction platform,
the outer surfaces of the distraction members forcibly abut the
spinous processes and distract the adjacent spinous processes away
from one another. The inner surface of at least one distraction
members forms a guide channel that is adapted to guide and position
an orthopedic implant into the distracted interspinous space. The
implant is adapted to maintain the increased distance between the
spinous processes after removal of the distraction members and
distraction platform.
[0009] In an alternative embodiment, distraction members are
percutaneously placed into the tissues adjacent to the spinous
processes and used to introduce an implant delivery device. The
implant is attached to and contained within the delivery device.
With actuation, the implant is rotated into the inter-spinous space
and used to forcibly separate the spinous processes.
[0010] In another embodiment, a pin or similar anchor is placed at
least partially through a first spinous process and positioned so
that the distal end abuts a surface of an adjacent spinous process.
The pin is used to separate the two adjacent spinous processes and
maintain the increased distance between them. In another
embodiment, a pin is placed into the base of the superior facet of
the lower vertebra and used to limit vertebral extension by
preventing the downward travel of the inferior facet of the
superior vertebra. Preferably, the pin has a hollow central cavity
that accommodates a bone graft or a bone graft substitute and is
adapted to fuse with the surrounding bone at the insertion site of
the inferior vertebra. Additional embodiments are disclosed that
modify the facet joint anatomy and provide direct nerve
decompression and/or a limit of vertebral extension.
[0011] In another embodiment, an implant is attached onto at least
one vertebral bone and adapted to limit the motion of the attached
bone relative to an adjacent vertebra. The motion pathway permitted
by the implanted is substantially curvilinear and has at least one
center of rotation near the natural Instantaneous Axis of Rotation
between adjacent vertebrae. Further, the implant permits greater
relative motion between the adjacent vertebrae in flexion than it
does in extension.
[0012] In one aspect, there is disclosed an orthopedic device,
comprising a first member adapted to be attached onto at least one
vertebra arid adapted to limit the motion of the attached vertebra
relative to an adjacent vertebra, wherein the first member defines
a motion pathway of the attached vertebra, wherein the motion
pathway is substantially curvilinear and has at least one center of
rotation near a natural instantaneous axis of rotation between the
attached vertebra and the adjacent vertebrae and, wherein the first
member provides limited relative motion between two vertebrae such
that the relative motion is greater in flexion than it is in
extension.
[0013] In another aspect, there is disclosed a method for the
treatment of spinal stenosis in which an orthopedic implant is
introduced into a space between the spinous processes of two
adjacent vertebras using a minimally invasive surgical technique,
comprising: placing two extension members into the space between
two adjacent spinous processes of adjacent vertebrae, wherein the
extension members are coupled to a distraction platform device
capable of adjusting a distance between the extension members;
using the distraction platform to separate the extension members,
wherein the outer surface of each extension member is adapted to
abut a spinous process of each adjacent vertebra so that separation
of the extension members by the platform produces an increase in
the distance between the adjacent spinous processes, wherein an
inner surface of at least one extension members forms a guide
channel that is adapted to guide and position an orthopedic implant
into the distracted inter-spinous space; placing an orthopedic
implant into the space between the two adjacent spinous processes,
wherein the implant is adapted to maintain the increase in distance
between the adjacent spinous processes after removal of the
extension members; and removing the extension members and the
distraction platform.
[0014] In another aspect, there is disclosed a method for the
treatment of spinal stenosis in which an orthopedic implant is
introduced into the space between the spinous processes of two
adjacent vertebrae using a minimally invasive surgical technique,
comprising: positioning two extension members adjacent to, but not
into, an inter-spinous space between two adjacent spinous
processes, wherein the extension members are coupled to a
distraction platform device capable of setting a distance between
the extension members; using the distraction platform to separate
the extension members, wherein the outer surface of each extension
member is adapted to separate tissue adjacent to the inter-spinous
space, wherein an inner surface of at least one of the extension
members forms a guide channel that is adapted to guide and position
an implant delivery device into the tissue adjacent to the
inter-spinous space, wherein the implant is adapted to be attached
onto the delivery device and be at least partially contained
therein, wherein the implant delivery device is adapted to rotate
the attached implant about a center point that is substantially
contained within the delivery device and through an angle range of
45 to 135 degrees; deploying the implant delivery device onto the
extension members, wherein the implant delivery device has an
attached orthopedic implant; placing the attached orthopedic
implant into the space between the two adjacent spinous processes,
wherein the implant is adapted to maintain a distance between the
spinous processes after removal of the extension members; and
removing the delivery device, extension members and the distraction
platform.
[0015] In another aspect, there is disclosed a method for the
treatment of spinal stenosis, comprising: placing a body of a pin
at least partially through a first spinous process such that one
end of the pin is positioned to abut a surface of a second,
adjacent spinous process that faces the first spinous process; and
using the pin to set and maintain a distracted space between the
spinous processes.
[0016] In yet another aspect, an orthopedic device is disclosed. In
one embodiment, the device comprises a first member configured to
attach onto at least one first vertebra and limit motion of the
first vertebra relative to a second, adjacent vertebra. The first
member defines a substantially curvilinear motion pathway of the
first vertebra having at least one center of rotation near a
natural instantaneous axis of rotation between the first vertebra
and the second vertebra. The first member is configured to provide
limited relative motion between the first vertebra and the second
vertebra such that the relative motion is greater in flexion than
it is in extension.
[0017] In another aspect, an assembly for placement or an
orthopedic implant within a target inter-spinous space of a spinal
column is disclosed. In one embodiment, the assembly comprises: (i)
an implant placement device comprising: at least a first extension
member and a second extension member each of the first and second
extension members comprising an elongated segment configured to
extend from a proximal aspect to a distal aspect and each of the
first and second extension members configured to be positioned
within the target inter-spinous space at the distal aspect thereof,
and a distraction mechanism configured to connect to the proximal
aspect of each of the first and the second extension members, and
to forcibly move the first extension member relative to the second
extension member the movement configured to produce at least some
expansion of the target inter-spinous space, (ii) a guide channel
formed at least in part by a bore configured to extend from a
proximal opening to distal opening in between the first and second
extension members, and (ii) an orthopedic implant configured to be
advanced at least partially through the guide channel and be
positioned within the target inter-spinous space. The first and
second extension members are removed from the target inter-spinous
space, yet the orthopedic implant remains positioned within the
inter-spinous space to maintain first and second vertebral bones of
the spinal column separated by a desired distance.
[0018] In another embodiment, the assembly comprises: (i) an
implant placement device comprising: at least a first extension
member and a second extension member each of the first and second
extension members comprising an elongated segment configured to
extend from a proximal aspect to a distal aspect and each of the
first and second extension members configured to be positioned
within the target inter-spinous space at the distal aspect thereof,
and a distraction mechanism configured to connect to the proximal
aspect of each of the first and the second extension members, and
to forcibly move the first extension member relative to the second
extension member the movement configured to produce at least some
expansion of the target inter-spinous space, the first and second
extension members thereby creating a guide channel therebetween,
(ii) an elongated member configured to be slidably positioned
within the guide channel during advancement of the first and second
extension members towards the target inter-spinous space, the
elongated member being shaped to separate tissues ahead of the
advancing first and second extension members, and (iii) an
orthopedic implant configured to be advanced at least partially
through the guide channel and be positioned within the target
inter-spinous space. The elongated member is removed prior to
advancement of the orthopedic implant through the guide channel.
The first and second extension members are removed from the target
inter-spinous space after the advancement of the orthopedic
implant.
[0019] The implants and methods described permit treatment of
spinal stenosis through a minimally invasive surgical procedure.
Other features and advantages will be apparent from the following
description of various embodiments, which illustrate, by way of
example, the principles of the disclosed devices and methods.
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] FIG. 1 shows a perspective view of an installer device that
is adapted to position an implant in the inter-spinous space
between two vertebras.
[0021] FIG. 2 shows the installer device in a distracted state.
[0022] FIG. 3 shows the installer device with an implant at the
distal region of the installer arms.
[0023] FIG. 4 illustrates an exemplary implant placed within the
inter-spinous space.
[0024] FIGS. 5A and 5B show perspective and cross-sectional views
of an implant, respectively.
[0025] FIGS. 6A and 6B show another embodiment of an installer
device without and with an exemplary imp/ant, respectively.
[0026] FIGS. 7 A and 7B show prospective and cross-sectional views
of an exemplary implant in the un-deployed state.
[0027] FIGS. 8A and 8B show prospective and cross-sectional views
of an exemplary implant in the deployed state.
[0028] FIG. 9A shows another embodiment of an installer device and
an implant delivery instrument.
[0029] FIG. 9B shows perspective views of an implant delivery
instrument.
[0030] FIG. 10 shows the delivery instrument after actuation such
that an implant has rotated to a deployment position.
[0031] FIG. 11 shows the linkage mechanism of the implant delivery
instrument.
[0032] FIG. 12 shows the delivery instrument coupled to the
installer device prior to deployment of the implant.
[0033] FIG. 13 shows the implant in the inter-spinous space after
deployment with the delivery instrument removed.
[0034] FIG. 14A shows another embodiment of an implant.
[0035] FIG. 14B shows an alternative application of the
implant.
[0036] FIG. 15 shows an implant positioned in a inter-spinous space
with a fixation screw anchoring the implant in place.
[0037] FIGS. 16 and 17 show perspective views of a device that is
configured for placement between the spinous processes of two
adjacent vertebras.
[0038] FIGS. 18 and 19 show exploded views of the device.
[0039] FIG. 20 shows a side, cross-sectional view of the device
mounted to a pair of vertebrae.
[0040] FIG. 21 shows a side, cross-sectional view of the device
mounted to a pair of vertebrae.
[0041] FIG. 22 shows perspective views of another embodiment in the
disassembled state.
[0042] FIG. 23 shows additional views of the assembled implant of
FIG. 22.
[0043] FIG. 24 shows the implant of FIG. 22 mounted on the
sacrum.
[0044] FIG. 25 illustrates an oblique view of the mounted implant
of FIG. 24.
[0045] FIG. 26 shows an additional embodiment.
[0046] FIGS. 27A and B show the implant of FIG. 26 placed into the
spinal column.
[0047] FIG. 28A shows an additional embodiment of an orthopedic
implant.
[0048] FIG. 28B shows an additional embodiment of an orthopedic
implant.
[0049] FIG. 29A shows a lateral view of the vertebral bodies while
FIG. 29B shows the implant in place.
[0050] FIGS. 30A and 30B show an additional embodiment of an
implant.
[0051] FIG. 31 shows perspective views of the implant.
[0052] FIG. 32 shows the implant of FIG. 31 placed into the spinal
column.
DETAILED DESCRIPTION
[0053] FIG. 1 shows a perspective view of an installer device 1605
that is adapted to position an orthopedic implant in the
inter-spinous space between the spinous processes of two adjacent
vertebras. For clarity of illustration, the vertebral bodies are
represented schematically and those skilled in the art will
appreciate that actual vertebral bodies include anatomical details
not shown in FIG. 1. The device 1605 includes a platform 1610
having an actuator 1615 that can be used to separate a pair of
distraction arms 1620a and 1620b. The platform member 1610 may
include a scale for measuring the distraction distance or the
distraction force. The scale can display the measured distance in a
recognized physical unit or as an arbitrary designation (such as,
for example, A, B, C, etc.) that is used for implant selection.
[0054] Each distraction arm 1620 has a semi-circular inner surface
so that, in the non-distracted state, the arms 1620 collectively
form an interior circular conduit. A curvilinear trocar with
sharpened distal end 1625b and discoid proximal member 1625a is
positioned through the circular conduit formed by arms 1620.
Discoid proximal member 1625a has locking tabs on its inferior
surface that interact with complimentary tabs 1622 of arms 1620 and
lock the trocar to the distraction arms. The sharpened end 1625b
emerges from the distal end of arms 1620 and, at the time of device
insertion, end 1625b divides the skin and soft tissue ahead of
advancing arms 1620. Preferably, the distraction arms 1620 are
positioned into the inter-spinous space at the stenotic spinal
level under x-ray guidance. The trocar is removed and actuator 1615
is rotated to separate the distraction arms and apply a distraction
force upon the spinous processes of the two adjacent vertebras.
[0055] FIG. 2 shows the device 1605 in a distracted state. With
rotation of actuator 1615, each distraction arm 1620 is forcibly
driven into the spinous process of the adjacent vertebral bone
producing distraction of the inter-spinous space. In an embodiment,
arms 1620 are curved, although the arms can be also straight or
partially curved. A pathway is formed between the separated arms
1620 through which an implant can be driven into the inter-spinous
space. The size of the needed implant is given by reading the scale
along platform member 1610. FIG. 3 shows the device 1605 with an
exemplary implant 1805 positioned at the distal region of the arms
1620. The implant 1805 is inserted into the proximal aspect of the
pathway and advanced distally until it rests within the
inter-spinous space. The implant is held in place by a placement
handle (not shown) and the distraction arms and platform are then
removed. Finally, the implant is distracted by actuating the
placement handle. The implant is shown in FIG. 4 resting within the
inter-spinous space.
[0056] FIGS. 5A and 5B illustrate perspective and cross-sectional
views, respectively, of the implant 1805. The implant 1805 includes
a first piece 1905 and a second piece 1910 that are movably
attached to one another. A pair of wedge-shaped bearing members
1915 form a bearing surface between the two pieces 1905 and 1910.
In addition, the pieces 1905 have respective shoulders 1925 that
abut one another to guide and limit relative movement there
between. The bearing members 1915 and the shoulders 1925 guide
movement between the two pieces 1905 and 1910 such that the pieces
can move and increase the dimensions of the implant 1805. The
implant can be initially delivered into the inter-spinous space in
a state of reduces size and then transitioned to the state of
enlarged size after it is positioned within the inter-spinous
space.
[0057] FIGS. 6A and 6B show another embodiment of an installer
device 2105. The device 2105 includes a platform 2110 having an
actuator 2115 that can be used to separate a pair of distractor
arms 2120. In this embodiment, the distractor arms are straight. As
discussed below, the arms 2110 can be used as a guide for
positioning an implant 2205 into the inter-spinous space (FIG. 6B)
FIGS. 7A and 78 show perspective and cross-sectional views of an
exemplary implant 2205 in the un-deployed state. Implant 2205
contains at least longitudinal tract 2207 that interacts with the
inner aspect of arms 2210. The implant 2205 includes first and
second members 2210 and 2215 that are movably attached. When the
members 2210 and 2215 are moved toward one another, one or more
pivotably mounted arias 2220 are moved to a position that extends
outwardly from the implant 2205. The arms can be moved to the
extended position after implantation in the inter-spinous
space.
[0058] FIGS. 8A and 8B show perspective and cross-sectional views
of an exemplary implant 2205 in the deployed state. Note that the
distal arms 2220 have a bearing articulation with the deploying
portion of member 2210 while the proximal arms 2220 have a
deformable base that is integrally attached to member 2210. Either
mechanism may be employed on any of mounted arms 2220.
[0059] FIG. 9A illustrates an additional embodiment. A distraction
platform with straight distraction arms is percutaneously
positioned under x-ray guidance. The arms are placed lateral to the
inter-spinous space. A delivery instrument 2303 is attached to the
implant and used to place the implant into the inter-spinous space.
FIG. 9B shows perspective views of the delivery instrument 2302. In
the illustrated embodiment, the instrument 2302 includes a
two-piece handle having a first arm 2310 and a second arm 2320 that
is movably mounted relative to the first arm 231b in a pivot or
trigger fashion. The first and second arms are ergonomically
arranged such that an operator can grasp the arms using a single
hand. For example, the first arm 2310 is sized and shaped to
support an operator's palm and thumb such as on a thumb grip 2322.
Likewise, the second arm 320 can be grasped by the operator's
fingers to pull the second arm 2320 toward the first au u 2310 and
actuate the instrument 2302. A biasing member 2325 is interposed
between the first and second arms. It should be appreciated that
the instrument can be actuated with other mechanisms and need not
use a two-piece handle configuration.
[0060] With reference still to FIG. 9B, a housing 2311 extends
outward from the handle. The housing 2311 is sized and shaped to
contain the implant 2205. In the illustrated embodiment, the
housing 2311 has an elongated, tube-like shape and is partially
hollow so as to contain the implant 2205 as well as an internal
actuation mechanism that expels the implant from the housing. A
slot 2330 is located at or near a distal end of the housing 2311.
The slot communicates with an internal cavity in the housing 2311
in which the implant 2205 resides. The slot is sufficiently long
and wide such that the implant 2205 can pass through the slot
during deployment of the implant. FIG. 10 illustrates the internal
mechanism of the placement device. FIG. 11 shows the instrument
2302 after actuation such that the implant 2205 has rotated (as
represented by the arrow R) to a deployment position.
[0061] FIG. 12 shows the delivery instrument 2302 coupled to the
installer device 2105 prior to deployment of the implant 2205. The
elongated housing 2311 is placed in between the distractor arms
2120 such that a distal end of the housing 2311 is lateral to the
inter-spinous space between the vertebrae. The delivery instrument
is then actuated to rotate the implant 2205 into the inter-spinous
space. FIG. 13 shows the implant 2205 in the inter-spinous space
after removal of delivery instrument 2302.
[0062] FIG. 14A shows another embodiment of an implant. In this
embodiment, the implant comprises a curved pin or screw 2805 that
is sized and shaped to be passed through the spinous process of a
vertebrae. The screw 2805 has a curved contour that permits a
portion of the screw to extend through the spinous process with a
distal region of the screw extending through the inter-spinous
space. A proximal end of the screw 2805 is positioned at the
exterior of the spinous process. The distal end of the screw 2805
abuts a surface of the spinous process of the adjacent vertebra.
The pin may be at least partially comprised of a bone graft or bone
graft substitute so as to fuse with the spinous process in which it
is embedded. The pin maybe embedded in a first spinous process and
abut a second spinous process, as shown in FIG. 14A, or it may be
alternatively embedded in the second spinous process and abut the
first spinous process, as shown in FIG. 14B.
[0063] FIG. 15 shows an implant positioned in an inter-spinous
space and affixed to the spine with a fixation screw 3010. The
implant 3005 is positioned within the disc space such that outer
surface of the implant abuts adjacent vertebrae. A fixation screw
3010 extends through the spinous process and into the implant 3005.
The screw may be at least partially comprised of a bone graft or
bone graft substitute so as to fuse with the spinous process in
which it is embedded. If the interior aspect of implant 3005 is
also at least partially comprised of a bone graft or bone graft
substitute, then screw 3010 can fuse with both the spinous process
and implant 3005. This provides a bone bridge between the implant
3005 and the spinous process without direct fusion of the implant
onto the spinous process.
[0064] FIGS. 16 and 17 show perspective views of a device 105 that
is configured for placement between the spinous processes of two
adjacent vertebral bodies. The device 105 includes a spacer region
or central region 110 that is sized and shaped to fit between the
spinous processes of the two adjacent vertebral bodies. The device
105 further includes a pair of attachment members 115 that are
adapted to attach and anchor onto the spinous process of at least
one of the vertebral bodies. The central region 110 can have a
variety of shapes and sizes for placement between the spinous
processes. The attachment members 115 can also have various sizes
and shapes for attachment to the spinous processes.
[0065] FIGS. 18 and 19 show exploded views of the device 105. The
device 105 includes attachment members 115 that are adapted to
attach and anchor onto the spinous process of at least one of the
vertebral bodies. Each attachment member 115 has a pair of
downwardly-extending aims 305 that are sized to receive a spinous
process therebetween. An upper portion of the attachment member 115
is sized and shaped to sit over the spinous process. The upper
portion has a borehole that is sized to receive a threaded screw
410 during implantation: A locking mechanism 415 can be within the
attachment, member 115 to serves to prevent unwanted movement
and/or back out of the screw 410. While illustrated as a locking
cam, the locking mechanism 415 may include any locking mechanism
known in the art.
[0066] A first bearing member 425 has a rounded articulating
surface that is adapted to interact with a complimentary
articulating surface on a second bearing member 430. The member 425
is sized and shaped to be received in a cavity inside the member
430 so as to permit at least some rotational movement therebetween.
A third bearing member 440 is at least partially dome-shaped and is
adapted to couple to the members 425 and 430. In particular, the
member 440 mates with the member 430 such as through a threaded
engagement.
[0067] With reference still to FIGS. 18 and 19, member 430 includes
a protrusion 445 that is sized and shaped to mate with an
indentation 450 in the member 425. In the assembled device, the
interaction of protrusion 445 and indentation 450 serves to limit
the amount of rotation and lateral flexion between the members 425
and 430.
[0068] FIG. 20 shows a side, cross-sectional views of the device
mounted to a pair of vertebrae. The members 115 can be coupled to
one another by mating the member 425 beneath the member 430 such
that articulating surfaces abut one another and permit rotational
movement therebetween. The member 440 is positioned below the
member 430 and secured thereto such as in a threaded relationship.
This retains the device in the assembled state.
[0069] FIG. 21 shows an enlarged, cross-sectional view of the
device in the assembled state and mounted between vertebrae. The
member 425 has a rounded surface 605. The surface 605 interacts
with a complimentary rounded surface 610 on the member 430. A space
630 is formed when the member 440 is secured onto the member 430.
The member 425 resides within the space 630 in the assembled
device. The space 630 permits a certain amount of "play" between
the articulation of members 430 and 425. In an embodiment, the
space 630 contains a malleable member that keeps members 425 and
430 in a preferred, neutral position and acts to return these
members to the neutral position when they move away from it.
[0070] In addition, the curvilinear surfaces 605 and 610 define a
spherical path of motion that is centered at Point A (shown in FIG.
20). That is, the surfaces 605 and 610 can move relative to one
another along a pathway that is curvilinear or spherical.
Alternative motion paths that are non-spherical may be
alternatively made. In specific, a configuration that is similar,
but not identical, to a hyperbolic paraboloid may be incorporated
within the articulating surface. Moreover, the interaction of the
protrusion 445 and indentation 450 allows a variable degree of
rotational movements of one vertebral body relative to the other.
The extent of rotation and lateral flexion permitted is dependant
on the degree of flexion of the vertebral bodies. That is, with the
vertebral bodies in flexion, the extent of rotation and lateral
flexion permitted by the device is greater that amount of 14
rotation and lateral flexion that is permitted when the vertebral
bodies are in extension. This feature reproduces the natural motion
characteristics between the vertebral bodies.
[0071] FIG. 22 illustrates perspective views of device 3305 in the
disassembled state. FIG. 23 shows sectional views of the assembled
device 3305. Threaded wall 3320 surrounds central cavity 3315 and
contains multiple full thickness bore holes 3325. The distal aspect
of wall 3320 contains interior threads 3340 that couple with
complimentary threads 3520 of distal member 3510. The central
cavity 3315 is adapted to house a bone graft or bone graft
substitute and permit fusion between the bone graft within cavity
3315 and the vertebral bone surrounding the outer aspect of device
3305. After placement of bone graft material within cavity 3315,
distal member 3510 is screwed onto device 3305. The fusion forms
across bore holes 3325.
[0072] The proximal aspect of device 3305 contains hexagonal cut
out 3360. Cut out 3360 is adapted to accept a hex screw driver and
the latter is used to drive device 3305 into bone. The proximal
aspect of device 3305 contains at least one flap 3605 that is
movably attached to device 3305. When a force is applied to the
proximal aspect of device 3305, flap 3605 transiently and
reversibly moves towards the center line of the device. In this
way, flap 3605 functions as a malleable member and imparts a
spring-like quality to the proximal aspect of device 3305.
[0073] In use, the central cavity 3315 is filed with a bone graft
and distal member 3510 is threaded onto device 3305. Once
assembled, distal member 3510 is rigidly attached to 3305. Under
x-ray guidance, the device is percutaneously driven into the base
of the superior articulating surface of the lower vertebral body
and abuts the inferior surface of the inferior articulating surface
of the superior vertebra. Preferably, a single device is used on
each side of the vertebral midline, so that two devices 3305 are
used at each stenotic level. The devices are shown attached to bone
in FIGS. 24 and 25. As illustrated, each device 3305 limits the
downward travel of the inferior articulating surface of the
superior vertebra and limits the degree of extension at that spinal
level. With time the bone contained within cavity 3315 will fuse
with the adjacent bone and rigidly anchor the device to the
vertebra. Because of the fusion the device does not to be anchored
into the pedicle portion of the vertebra and it can be short in
length.
[0074] FIG. 26 illustrates device 3705. The device is intended to
reside within the facet joint and be anchored onto one, but not
both, of the adjacent vertebras. The device may be affixed onto the
vertebral bone using pins and a bone screw or the device may be at
least partially comprised of a bone graft or bone graft substitute
so as to fuse onto the adjacent bone. The device may be coated/made
with osteo-conductive (such as deminerized bone matrix,
hydroxyapatite, and the like) and/or osteo-inductive (such as
Transforming Growth Factor "TGF-B," Platelet-Derived Growth Factor
"PDGF," BoneMorphogenic Protein "BMP," and the like) bio-active
materials that promote bone formation. Further, one or more
surfaces may be made with a porous ingrowth surface (such as
titanium wire mesh, plasma-sprayed titanium, tantalum, Porous CoCr,
and the like), provided with a bioactive coating, made using
tantalum, and/or helical rosette carbon nanotubes (or other carbon
nanotube-based coating) in order to promote bone in-growth or
establish a mineralized connection between the bone and the
implant.
[0075] The device is shown anchored to bone in FIGS. 27A and 27B.
It is intended to at least partially replace the function of a
natural facet joint that been at least partially removed at
surgery. It may alternatively be used within an intact but
degenerated facet joint to reestablish a functional articulation.
FIG. 28A shows an additional embodiment of an orthopedic implant
705 positioned on two vertebral bodies of the lumbar spine. The
implant 705 is attached onto the superior articulating surface and
lamina of the lower vertebra and functions to stop the downward
movement of the inferior articulating surface of the upper
vertebral body. In this way, the device stops the extension of the
two vertebral bodies and keeps them in relative flexion. The device
can include contains one or more bore holes through which one or
more screws are passed and anchored onto the underlying bone. As
shown, the inferior aspect of the lamia of the upper vertebra is
preferably removed (laminotomy) to decompress the nerve elements
prior to device placement.
[0076] FIG. 28B shows an additional embodiment of an orthopedic
implant 805 positioned on two vertebral bodies of the lumbar spine.
The implant 805 is attached onto the superior articulating surface
and lamina of the lower vertebra and transverses the facet joint
between the two vertebral bodies. The superior surface of the
device abuts the inferior aspect of the pedicle of the upper
vertebral body. The implant functions to stop the extension of the
two vertebral bodies and keeps them in relative flexion. The
implant 805 can contain one or more bore holes through which screws
are passed and anchored onto the underlying bone. FIG. 29A shows a
lateral view of the vertebral bodies and FIG. 29B shows the implant
805 in place. Note that implant placement will necessarily place
the lower articulating surface of the upper vertebral body more
posteriorly and at least partially realign an anterior
spondylolisthesis.
[0077] FIGS. 30A and 30B show an additional embodiment of an
implant 1305. In an embodiment, the implant 1305 is a "c" shaped
implant. FIG. 31 shows perspective views of the implant 1305. The
implant 1305 functions to separate the top of the superior
articular surface of the inferior body from the inferior aspect of
the pedicle of the upper vertebral body. The implant 1305 has a
size and shape such that the opening of the "C" can be positioned
over at least a portion of the vertebral body. In an embodiment, a
separate attachment device is not used to attach the implant 1305
to bone. In another embodiment, the implant 1305 contain one or
more bore holes through which screws are passed and anchored onto
the underlying bone. FIG. 32 shows the implant 1305 positioned on
the bone.
[0078] The disclosed devices or any of their components can be made
of any biologically adaptable or compatible materials. Materials
considered acceptable for biological implantation are well known
and include, but are not limited to, stainless steel, titanium,
tantalum, combination metallic alloys, various plastics, resins,
ceramics, biologically absorbable materials and the like. Any
components may be also coated/made with osteo-conductive (such as
deminerized bone matrix, hydroxyapatite, and the like) and/or
osteo-inductive (such as Transforming Growth Factor "TGF-B,"
Platelet-Derived Growth Factor "PDGF," Bone-Morphogenic Protein
"BMP," and the like) bio-active materials that promote bone
formation. Further, any surface may be made with a porous ingrowth
surface (such as titanium wire mesh, plasma-sprayed titanium,
tantalum, porous CoCr, and the like), provided with a bioactive
coating, made using tantalum, and/or helical rosette carbon
nanotubes (or other carbon nanotube-based coating) in order to
promote bone in-growth or establish a mineralized connection
between the bone and the implant, and reduce the likelihood of
implant loosening. Lastly, the system or any of its components can
also be entirely or partially made of a shape memory material or
other deformable material.
[0079] Although embodiments of various methods and devices are
described herein in detail with reference to certain versions, it
should be appreciated that other versions, embodiments, methods of
use, and combinations thereof are also possible. Therefore the
spirit and scope of the appended claims should not be limited to
the description of the embodiments contained herein.
* * * * *