U.S. patent application number 13/235978 was filed with the patent office on 2012-01-12 for methods and surgical kits for minimally-invasive facet joint fusion.
Invention is credited to David A. Petersen.
Application Number | 20120010620 13/235978 |
Document ID | / |
Family ID | 40455392 |
Filed Date | 2012-01-12 |
United States Patent
Application |
20120010620 |
Kind Code |
A1 |
Petersen; David A. |
January 12, 2012 |
METHODS AND SURGICAL KITS FOR MINIMALLY-INVASIVE FACET JOINT
FUSION
Abstract
Disclosed herein are methods and surgical kits that can be used
to fuse facet joints via a minimally invasive procedure (including
an arthroscopic or percutaneous procedure). An exemplary method
includes creating an incision; locating a facet joint with a distal
end of a pin; sliding a substantially hollow drill guide over said
pin wherein said drill guide comprises a proximal end, a distal
end; removing said pin from within said drill guide; inserting a
drill bit into said drill guide; drilling a hole into a bone of
said facet joint; removing said drill bit; inserting a facet joint
bone plug into said hole using a bone plug inserter having a raised
portion at or near is proximal end, wherein said raised portion
prevents over-insertion of said bone plug; and removing said drill
guide.
Inventors: |
Petersen; David A.;
(Clearwater, FL) |
Family ID: |
40455392 |
Appl. No.: |
13/235978 |
Filed: |
September 19, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12238255 |
Sep 25, 2008 |
8021392 |
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13235978 |
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11232519 |
Sep 22, 2005 |
7708761 |
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12238255 |
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10992720 |
Nov 22, 2004 |
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11232519 |
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Current U.S.
Class: |
606/80 ;
606/96 |
Current CPC
Class: |
A61F 2/4611 20130101;
A61B 2090/034 20160201; A61B 50/30 20160201; A61F 2002/30881
20130101; A61F 2/446 20130101; A61B 17/1757 20130101; A61F
2002/3085 20130101; A61F 2002/30822 20130101; A61F 2/28 20130101;
A61F 2002/30785 20130101; A61F 2/4455 20130101; A61F 2002/30859
20130101; A61F 2002/30841 20130101; A61F 2002/30884 20130101; A61F
2/4405 20130101; A61F 2310/00359 20130101 |
Class at
Publication: |
606/80 ;
606/96 |
International
Class: |
A61B 17/16 20060101
A61B017/16; A61B 17/58 20060101 A61B017/58 |
Claims
1. A method comprising: creating an incision; locating a facet
joint with a distal end of a pin wherein said facet joint is formed
between two opposing bones and said pin comprises said distal end
and a proximal end; sliding a substantially hollow drill guide over
said pin wherein said drill guide comprises a proximal end, a
distal end, and a handle wherein said handle is nearer to the
proximal end of the drill guide than to the distal end, said distal
end comprises opposed teeth that can be inserted into said facet
joint and; removing said pin from within said drill guide;
inserting a drill bit into said drill guide; drilling a hole into a
bone of said facet joint; removing said drill bit; inserting a
facet joint bone plug into said hole using a bone plug inserter
having a raised portion at or near is proximal end, wherein said
raised portion prevents over-insertion of said bone plug; and
removing said drill guide.
2. A method according to claim 1 wherein the distal end of the
drill guide comprises two opposed teeth.
3. A method according to claim 1 wherein the distal end of said
drill guide comprises a plurality of teeth, wherein the plurality
of teeth comprises two opposed teeth and one or more smaller teeth
disposed between said two opposed teeth.
4. A method according to claim 1 further comprising confirming the
location of said pin at said facet joint.
5. A method according to claim 4 wherein said confirming is
accomplished with at least one x-ray.
6. A method according to claim 1 wherein said drill guide comprises
a marking that indicates the rotational orientation of said opposed
teeth.
7. A method according to claim 1 wherein said drilling comprises
grinding the bone and compacting some of the drilled bone within
said hole.
8. A method comprising: creating an incision; locating a facet
joint with a distal end of a pin wherein said facet joint is formed
between two opposing bones and said pin comprises said distal end
and a proximal end; sliding a substantially hollow spatula over
said pin wherein said spatula comprises a proximal end, a distal
end and a body wherein said distal end comprises a planar wedge;
adjusting the rotation of said planar wedge until said planar wedge
enters said facet joint; sliding a substantially hollow drill guide
over said spatula wherein said drill guide comprises a proximal
end, a distal end, and a handle wherein said handle is nearer to
the proximal end of the drill guide than to the distal end, said
distal end comprises opposed teeth that can be inserted into said
facet joint; removing said spatula from within said drill guide;
inserting a drill bit into said drill guide; drilling a hole into a
bone of said facet joint; removing said drill bit; inserting a
facet joint bone plug into said hole using a bone plug inserter
having a raised portion at or near its proximal end, wherein said
raised portion prevents over-insertion of said bone plug; and;
removing said drill guide; and closing said incision wherein said
pin has also been removed prior to said closing of said
incision.
9. A method according to claim 8 wherein the distal end of the
drill guide comprises two opposed teeth.
10. A method according to claim 8 wherein said distal end of said
drill guide comprises a plurality of teeth, wherein the plurality
of teeth comprises two opposed teeth and one or more smaller teeth
disposed between said two opposed teeth.
11. A method according to claim 8 further comprising confirming the
location of said pin at said facet joint.
12. A method according to claim 11 wherein said confirming is
accomplished with at least one x-ray.
13. A method according to claim 8 wherein said body of said spatula
comprises a marking that can indicate the orientation of said
planar wedge.
14. A method according to claim 13 wherein when said spatula
further comprises a marking and wherein when said marking on said
drill guide is matched or aligned with said marking on said
spatula, the orientation of said opposed teeth is in approximately
the same plane defined by said planar wedge.
15. A method according to claim 14 further comprising the step of
aligning said markings on said spatula and said drill guide.
16. A method according to claim 8 wherein said inserting of said
facet joint bone plug into said hole comprises sliding an inserter
instrument into said drill guide wherein said inserter instrument
has a proximal end and a distal end and a facet joint bone plug
associated with said distal end; and disengaging the facet joint
bone plug from said distal end of said inserter instrument into
said drilled hole.
17. A method according to claim 8 further comprising tapping said
spatula further into said facet joint following the initial
inserting of said planar wedge into said facet joint.
18. A method according to claim 8 further comprising tapping said
drill guide following said aligning of said markings so that said
opposed teeth of said drill guide engage facet joint bone to secure
the orientation of said drill guide until said removing of said
drill guide.
19. A method according to claim 8 further comprising tapping said
facet joint bone plug into said facet joint following said
inserting.
20. A method according to claim 8 wherein said drilling comprises
grinding the bone and compacting some of the drilled bone within
said hole.
21. A method comprising: creating an incision; locating a facet
joint with a spinal pin; accessing said facet joint with a
substantially hollow spatula wherein said spatula comprises a
proximal end, a distal end, and a body wherein said distal end
comprises a planar wedge and said accessing comprises sliding said
substantially hollow spatula over said spinal pin while adjusting
the rotation of said planar wedge until said planar wedge enters
said facet joint; sliding a substantially hollow drill guide over
said spatula wherein said drill guide comprises a proximal end, a
distal end, and a handle wherein said handle is nearer to the
proximal end of said drill guide than to said distal end and
wherein said distal end comprises opposed teeth; removing said
spinal pin and said spatula from within said drill guide; inserting
a drill bit into said drill guide; drilling a hole into a bone of
said facet joint; removing said drill bit; sliding an inserter
instrument into said drill guide wherein said inserter instrument
has a proximal end and a distal end, wherein a facet joint bone
plug is associated with said distal end and wherein said proximal
end comprises a raised portion that prevents over-insertion of said
facet joint bone plug; disengaging the facet joint bone plug from
said distal end of said inserter instrument into said drilled hole;
and removing said drill guide.
22. A method according to claim 21 further comprising confirming
the location of said spinal pin at said facet joint.
23. A method according to claim 22 wherein said confirming is
accomplished with at least one x-ray.
24. A method according to claim 21 further comprising tapping said
spatula further into said facet joint following the initial entry
of said planar wedge into said facet joint.
25. A method according to claim 21 further comprising tapping said
drill guide so that said opposed teeth of said drill guide engage
facet joint bone to secure the orientation of said drill guide
until said removing of said drill guide.
26. A method according to claim 21 further comprising tapping said
facet joint bone plug into said hole following said facet joint
bone plug's disengagement from said inserter instrument.
27. A method according to claim 21 wherein said spatula and said
drill guide each further comprises a marking, wherein when said
marking on said drill guide is matched or aligned with said marking
on said spatula, the orientation of said opposed teeth is in
approximately the same plane defined by said planar wedge.
28. A method according to claim 27 further comprising the step of
matching or aligning said markings on said spatula and said drill
guide.
29. A method according to claim 21 wherein said distal end of said
drill guide comprises two opposed teeth.
30. A method according to claim 21 wherein said distal end of said
drill guide comprises a plurality of teeth, wherein said plurality
of teeth comprises two opposed teeth and one or more smaller teeth
disposed between said two opposed teeth.
31. A method according to claim 21 wherein said drilling comprises
grinding the bone and compacting some of the drilled bone within
said hole.
32. A surgical kit comprising: a substantially hollow spatula
comprising a proximal end, a distal end, and a body wherein said
distal end comprises a planar wedge; and a a drill guide comprising
a proximal end, a distal end, and a handle wherein said handle is
nearer to the proximal end of said drill guide than to said distal
end and wherein said distal end comprises opposed teeth; a spinal
pin; a drill bit; a bone plug inserter comprising a proximal end
and a distal end, wherein the distal end is configured to interact
with a bone plug and wherein said proximal end comprises a raised
portion that prevents over-insertion of said bone plug; a bone plug
holder; and wherein all components of said kit can be stored and
sterilized in a single autoclavable tool box.
33. The surgical kit of claim 29 wherein said spatula and said
drill guide each further comprises a marking, wherein when said
marking on said drill guide is matched or aligned with said marking
on said spatula, the orientation of said opposed teeth is in
approximately the same plane defined by said planar wedge.
34. The surgical kit of claim 30 wherein said marking on said
spatula indicates the rotation of said planar wedge.
35. The surgical kit of claim 29 further comprising one or more
tools selected from the group consisting of a spinal needle, an
impacter, a hammer, a drill, a reamer, a dilator and a bone
plug.
36. The surgical kit of claim 29 further comprising a bone
plug.
37. The surgical kit of claim 32 wherein the drill bit is
configured to grind the bone and compact some of the drilled bone
within the hole.
Description
PRIOR APPLICATIONS
[0001] This application is a continuation-in-part of U.S. patent
application Ser. No. 11/232,519 filed Sep. 22, 2005 which is a
continuation-in-part of U.S. patent application Ser. No.
10/992,720, filed Nov. 22, 2004.
FIELD OF THE INVENTION
[0002] The present invention relates to methods and surgical kits
that can be used to fuse facet joints through minimally invasive
procedures.
BACKGROUND OF THE INVENTION
[0003] In the United States, about 10% of the population will
suffer from back pain sometime in the next year. This occurrence is
more than any other injury or disease except for the common cold
and flu. About one-third of those suffering from back pain will not
recover and will live with persistent, disabling symptoms. These
numbers are cumulative year after year.
[0004] One root cause of back pain, particularly the persistent and
disabling kind, is problems (including arthritis) with facet
joints. The back of each vertebra has two sets of facet joints. One
pair faces upward and the other pair faces downward. Within each
set there is a facet joint on the left side of each vertebra and a
facet joint on the right side of each vertebra.
[0005] Facet joints are the system of joints that allow movement
(forward bending, backward bending and twisting) of the spine.
While these joints allow movement of the spine, their interlocking
nature also helps to stabilize the spine.
[0006] Similar to other joints in the body, each facet joint is
surrounded by a capsule of connective tissue and produces synovial
fluid to nourish and lubricate the joint. The joint surfaces
themselves are coated with a thick spongy material called articular
cartilage that enables the bones of each joint to smoothly move
against the other.
[0007] Osteoarthritis is probably the most common cause of facet
joint pain. This degenerative disease causes progressive cartilage
deterioration. Without the spongy cartilaginous cushion, joint
bones begin to rub against each other when at rest and during
movement causing a substantial amount of pain. Therefore, one
option to treat this type of pain is to join rubbing portions of
bone together so that this painful friction does not occur.
[0008] Present surgical solutions available for facet joint
dysfunctions are high-risk, complex and invasive pedicle screw or
compression screw based operations associated with prolonged
recovery times (such as from about 6 to 24 months; see, for
example, U.S. Pat. No. 6,485,518 and U.S. Pat. No. 6,648,893. The
high risk nature of these surgeries leads to uncertain clinical
outcomes which can motivate doctors and patients to choose
non-surgical symptomatic treatments. While these treatments can
help to alleviate back pain temporarily, the underlying cause of
the pain continues to progressively worsen. Moreover, there are
additional problems associated with screw-based approaches to facet
joint fusion. For example, screw-type fixations can work their way
loose over time, negating any beneficial effect of the original
procedure. Thus, there is room for great improvement in the
surgical treatment of facet joint dysfunction.
SUMMARY OF THE INVENTION
[0009] The present invention provides a minimally-invasive
procedure and associated surgical tools that can be used to fuse
facet joint bones without the use of a screw-based approach.
Instead of relying on a screw to hold rubbing facet joints
together, the present invention drills a hole into the facet joint
and inserts a bone plug into the created hole. The bone plug allows
natural bone in-growth into and around the plug such that a strong
and permanent fusion results. The present invention may be so
minimally-invasive that, in some embodiments, it can be practiced
arthroscopically or percutaneously. Moreover, in many instances,
the procedure can be out-patient.
[0010] Specifically, one embodiment according to the present
invention includes a method comprising: creating an incision;
locating a facet joint with a distal end of a pin wherein the facet
joint is formed between two opposing bones and the pin includes a
distal end and a proximal end; inserting a spatula; sliding a
substantially hollow drill guide over the spatula/pin wherein the
drill guide includes a proximal end, a distal end, a handle and a
marking wherein the handle is nearer to the proximal end of the
drill guide than to the distal end and wherein the distal end
includes opposed teeth that can be inserted into the facet joint
and wherein the marking indicates the rotational orientation of the
two opposed teeth; removing the pin from within the drill guide;
inserting a drill bit into the drill guide; drilling a hole into a
bone of the facet joint; removing the drill bit; inserting a facet
joint bone plug into the hole; and removing the drill guide. In
some embodiments, there are two opposed teeth. In some embodiments,
the hole is drilled in a manner that permits some of the drilled
bone to remain in the drilled hole.
[0011] Another embodiment according to the present invention
includes a method comprising creating an incision; locating a facet
joint with a distal end of a pin wherein the facet joint is formed
between two opposing bones and the pin includes a distal end and a
proximal end; sliding a substantially hollow spatula over the pin
wherein the spatula includes a proximal end, a distal end and a
body wherein the distal end includes a planar wedge and the body
includes a marking that can indicate the orientation of the planar
wedge; adjusting the rotation of the planar wedge until the planar
wedge enters the facet joint; sliding a substantially hollow drill
guide over the spatula wherein the drill guide includes a proximal
end, a distal end, a handle and a marking wherein the handle is
nearer to the proximal end of the drill guide than to the distal
end, wherein the distal end includes two opposed teeth that can be
inserted into the facet joint and the marking indicates the
rotational orientation of the two opposed teeth and wherein when
the marking on the drill guide is matched or aligned with the
marking on the spatula, the orientation of the two opposed teeth is
in approximately the same plane defined by the planar wedge;
aligning the markings on the spatula and the drill guide; removing
the spatula from within the drill guide; inserting a drill bit into
the drill guide; drilling a hole into a bone of the facet joint;
removing the drill bit; inserting a facet joint bone plug into the
hole; removing the drill guide; and closing the incision wherein
the pin has also been removed prior to the closing of the
incision.
[0012] In other embodiments according to the present invention, the
inserting of the facet joint bone plug into the hole includes
sliding an inserter instrument into the drill guide wherein the
inserter instrument has a proximal end and a distal end and a facet
joint bone plug associated with the distal end; and disengaging the
facet joint bone plug from the distal end of the inserter
instrument into the drilled hole.
[0013] A particular embodiment according to the present invention
includes a method comprising creating an incision; locating a facet
joint with a spinal pin; accessing the facet joint with a
substantially hollow spatula wherein the spatula includes a
proximal end, a distal end, a body and a marking on the body
wherein the distal end includes a planar wedge and the accessing
includes sliding the substantially hollow spatula over the spinal
pin while adjusting the rotation of the planar wedge until the
planar wedge enters the facet joint; sliding a substantially hollow
drill guide over the spatula wherein the drill guide includes a
proximal end, a distal end, a handle and a marking wherein the
handle is nearer to the proximal end of the drill guide than to the
distal end and wherein the distal end includes two opposed teeth
and wherein when the marking on the drill guide is matched or
aligned with the marking on the spatula, the orientation of the
opposed teeth is in approximately the same plane defined by the
planar wedge; matching or aligning the markings on the spatula and
the drill guide; removing the spinal pin and the spatula from
within the drill guide; inserting a drill bit into the drill guide;
drilling a hole into a bone of the facet joint; removing the drill
bit; sliding an inserter instrument into the drill guide wherein
the inserter instrument has a proximal end and a distal end and a
facet joint bone plug associated with the distal end; disengaging
the facet joint bone plug from the distal end of the inserter
instrument into the drilled hole; and removing the drill guide. In
some embodiments, the drilling includes grinding the bone and
compacting some of the drilled bone within said hole.
[0014] In particular embodiments according to the present
invention, the above described methods can further comprise
confirming the location of the pin at the facet joint. In one
embodiment, the confirming is accomplished with at least one
x-ray.
[0015] In another embodiment according to the present invention,
the method further includes tapping the spatula further into the
facet joint following the initial inserting of the planar wedge
into the facet joint.
[0016] In another embodiment according to the present invention,
the method further includes tapping the drill guide following the
aligning of the markings so that the opposed teeth of the drill
guide engage facet joint bone to secure the orientation of the
drill guide until the removing of the drill guide.
[0017] In another embodiment according to the present invention,
the method further includes tapping the facet joint bone plug into
the facet joint following the inserting.
[0018] In other embodiments, the present invention includes a
method including creating an incision; locating a facet joint with
a distal end of a pin wherein the facet joint is formed between two
opposing bones and the pin includes the distal end and a proximal
end; sliding a substantially hollow drill guide over the pin
wherein the drill guide includes a proximal end, a distal end, and
a handle wherein the handle is nearer to the proximal end of the
drill guide than to the distal end, the distal end includes opposed
teeth that can be inserted into the facet joint and; removing the
pin from within the drill guide; inserting a drill bit into the
drill guide; drilling a hole into a bone of the facet joint;
removing the drill bit; inserting a facet joint bone plug into the
hole using a bone plug inserter having a raised portion at or near
is proximal end, wherein the raised portion prevents over-insertion
of the bone plug; and removing the drill guide. In some
embodiments, the distal end of the drill guide includes two opposed
teeth. In other embodiments, the distal end of the drill guide
includes a plurality of teeth, wherein the plurality of teeth
includes two opposed teeth and one or more smaller teeth disposed
between the two opposed teeth. In some embodiments, the method also
includes confirming the location of the pin at the facet joint, for
example by taking at least one x-ray. In certain embodiments, the
drill guide includes a marking that indicates the rotational
orientation of the opposed teeth. In some embodiments, the drilling
includes grinding the bone and compacting some of the drilled bone
within the hole.
[0019] In certain embodiments, the present invention includes a
method including: creating an incision; locating a facet joint with
a distal end of a pin wherein the facet joint is formed between two
opposing bones and the pin includes the distal end and a proximal
end; sliding a substantially hollow spatula over the pin wherein
the spatula includes a proximal end, a distal end and a body
wherein the distal end includes a planar wedge; adjusting the
rotation of the planar wedge until the planar wedge enters the
facet joint; sliding a substantially hollow drill guide over the
spatula wherein the drill guide includes a proximal end, a distal
end, and a handle wherein the handle is nearer to the proximal end
of the drill guide than to the distal end, the distal end includes
opposed teeth that can be inserted into the facet joint; removing
the spatula from within the drill guide; inserting a drill bit into
the drill guide; drilling a hole into a bone of the facet joint;
removing the drill bit; inserting a facet joint bone plug into the
hole using a bone plug inserter having a raised portion at or near
its proximal end, wherein the raised portion prevents
over-insertion of the bone plug; removing the drill guide; and
closing the incision wherein the pin has also been removed prior to
the closing of the incision. In particular embodiments, the distal
end of the drill guide includes two opposed teeth. In certain
embodiments, the distal end of the drill guide includes a plurality
of teeth, wherein the plurality of teeth includes two opposed teeth
and one or more smaller teeth disposed between the two opposed
teeth. In some embodiments, the method also includes confirming the
location of the pin at the facet joint, including by taking at
least one x-ray. In particular embodiments, the body of the spatula
includes a marking that can indicate the orientation of the planar
wedge. In other embodiments, the spatula further includes a marking
and wherein when the marking on the drill guide is matched or
aligned with the marking on the spatula, the orientation of the
opposed teeth is in approximately the same plane defined by the
planar wedge. In some embodiments, the method also includes the
step of aligning the markings on the spatula and the drill guide.
In some embodiments, the step of inserting the facet joint bone
plug into the hole includes sliding an inserter instrument into the
drill guide wherein the inserter instrument has a proximal end and
a distal end and a facet joint bone plug associated with the distal
end; and disengaging the facet joint bone plug from the distal end
of the inserter instrument into the drilled hole. In some
embodiments, the method also includes tapping the spatula further
into the facet joint following the initial inserting of the planar
wedge into the facet joint. In some embodiments, the method also
includes tapping the drill guide following the aligning of the
markings so that the opposed teeth of the drill guide engage facet
joint bone to secure the orientation of the drill guide until the
removing of the drill guide. In some embodiments, the method also
includes tapping the facet joint bone plug into the facet joint
following the inserting. In some embodiments, the drilling includes
grinding the bone and compacting some of the drilled bone within
the hole.
[0020] In other embodiments, the present invention includes a
method including: creating an incision; locating a facet joint with
a spinal pin; accessing the facet joint with a substantially hollow
spatula wherein the spatula includes a proximal end, a distal end,
and a body wherein the distal end includes a planar wedge and the
accessing includes sliding the substantially hollow spatula over
the spinal pin while adjusting the rotation of the planar wedge
until the planar wedge enters the facet joint; sliding a
substantially hollow drill guide over the spatula wherein the drill
guide includes a proximal end, a distal end, and a handle wherein
the handle is nearer to the proximal end of the drill guide than to
the distal end and wherein the distal end includes opposed teeth;
removing the spinal pin and the spatula from within the drill
guide; inserting a drill bit into the drill guide; drilling a hole
into a bone of the facet joint; removing the drill bit; sliding an
inserter instrument into the drill guide wherein the inserter
instrument has a proximal end and a distal end, wherein a facet
joint bone plug is associated with the distal end and wherein the
proximal end includes a raised portion that prevents over-insertion
of the facet joint bone plug; disengaging the facet joint bone plug
from the distal end of the inserter instrument into the drilled
hole; and removing the drill guide. In some embodiments, the method
also includes confirming the location of the spinal pin at the
facet joint, for example by taking at least one x-ray. In other
embodiments, the method also includes tapping the spatula further
into the facet joint following the initial entry of the planar
wedge into the facet joint. In some embodiments, the method also
includes tapping the drill guide so that the opposed teeth of the
drill guide engage facet joint bone to secure the orientation of
the drill guide until the removing of the drill guide. In some
embodiments, the method also includes tapping the facet joint bone
plug into the hole following the facet joint bone plug's
disengagement from the inserter instrument. In some embodiments,
the spatula and the drill guide each further includes a marking,
wherein when the marking on the drill guide is matched or aligned
with the marking on the spatula, the orientation of the opposed
teeth is in approximately the same plane defined by the planar
wedge. In some embodiments, the method also includes the step of
matching or aligning the markings on the spatula and the drill
guide. In some embodiments the distal end of the drill guide
includes two opposed teeth. In some embodiments, the distal end of
the drill guide includes a plurality of teeth, wherein the
plurality of teeth includes two opposed teeth and one or more
smaller teeth disposed between the two opposed teeth. In some
embodiments, the drilling includes grinding the bone and compacting
some of the drilled bone within the hole.
[0021] The present invention also includes surgical kits. In one
embodiment according to the present invention the surgical kit
includes a pin comprising a distal end and a proximal end and a
substantially hollow drill guide wherein the drill guide includes a
proximal end, a distal end, a handle and a marking wherein the
handle is nearer to the proximal end of the drill guide than to the
distal end and wherein the distal end includes opposed teeth and
wherein the marking indicates the rotational orientation of the two
opposed teeth. In some embodiments, there are two opposed
teeth.
[0022] In another embodiment of a surgical kit according to the
present invention the surgical kit further includes a bone
plug.
[0023] An additional embodiment of a surgical kit according to the
present invention includes a surgical kit comprising a
substantially hollow spatula comprising a proximal end, a distal
end, a body and a marking on the body wherein the distal end
includes a planar wedge and the marking indicates the rotation of
the planar wedge; and a drill guide comprising a proximal end, a
distal end, a handle and a marking wherein the handle is nearer to
the proximal end of the drill guide than to the distal end and
wherein the distal end includes two opposed teeth and wherein when
the marking on the drill guide is matched or aligned with the
marking on the spatula when the drill guide is place over the
spatula, the orientation of the opposed teeth is in approximately
the same plane defined by the planar wedge.
[0024] Surgical kit embodiments according to the present invention
can further comprise a tool selected from the group consisting of
an inserter instrument, a spinal pin, a spinal needle, an impacter,
a hammer, a drill bit, a drill, a reamer, a dilator, a bone plug
holder, a bone plug, and an autoclavable surgical tool kit box.
[0025] One particular surgical kit according to the present
invention includes a surgical kit comprising a substantially hollow
spatula comprising a proximal end, a distal end, a body and wherein
the distal end includes a planar wedge; and a drill guide
comprising a proximal end, a distal end, and a handle wherein the
handle is nearer to the proximal end of the drill guide than to the
distal end and wherein the distal end includes opposed teeth. In
some embodiments, the substantially hollow spatula includes a
marking on the body. In some embodiments, the marking on the body
of the spatula indicates the rotation of the planar wedge. In some
embodiments, the distal end of the drill guide includes two opposed
teeth. In some embodiments the drill guide includes a marking. In
some such embodiments, the when the marking on the drill guide is
matched or aligned with the marking on the spatula when the drill
guide is place over the spatula, the orientation of the opposed
teeth is in approximately the same plane defined by the planar
wedge
[0026] Additional embodiments of kits according to the present
invention can also individually, collectively or in various
combinations include one or more of a spinal pin, a spinal needle,
an impacter, a hammer, a reamer, a drill bit, a reamer, a drill, a
dilator, a dilator tube, a guide wire, a bone plug, and a bone plug
holder wherein all components of the kit except for the reamer can
be re-used, stored and sterilized in a single autoclavable surgical
tool kit box.
[0027] In some embodiments the present invention includes a
surgical kit including a substantially hollow spatula comprising a
proximal end, a distal end, and a body wherein the distal end
includes a planar wedge; and a drill guide comprising a proximal
end, a distal end, and a handle wherein the handle is nearer to the
proximal end of the drill guide than to the distal end and wherein
the distal end includes opposed teeth; a spinal pin; a drill bit; a
bone plug inserter comprising a proximal end and a distal end,
wherein the distal end is configured to interact with a bone plug
and wherein the proximal end includes a raised portion that
prevents over-insertion of the bone plug; a bone plug holder; and
wherein all components of the kit can be stored and sterilized in a
single autoclavable tool box. In certain embodiments, the spatula
and the drill guide each further includes a marking, wherein when
the marking on the drill guide is matched or aligned with the
marking on the spatula, the orientation of the opposed teeth is in
approximately the same plane defined by the planar wedge. In
particular embodiments, the marking on the spatula indicates the
rotation of the planar wedge. In other embodiments, the surgical
tool kit also includes a spinal needle, an impacter, a hammer, a
drill, a reamer, a dilator or a bone plug. In some embodiments the
drill bit is configured to grind the bone and compact some of the
drilled bone within the hole.
[0028] The methods and surgical kits of the present invention
described above can also be used or sold in conjunction with bone
plugs according to the present invention. In one embodiment along
the length of the bone plug there is at least one major diameter
and at least one minor diameter. In another embodiment the bone
plug includes a fin or a series of fins. In some embodiments, the
fins in the series are spaced approximately 1 mm apart.
BRIEF DESCRIPTION OF THE DRAWINGS
[0029] FIG. 1 shows facet joint location with surgical pins.
[0030] FIG. 2 shows an alternative view of facet joint location
with surgical pins.
[0031] FIGS. 3-5 depict insertion of a drill guide directly over a
surgical pin without the use of a spatula.
[0032] FIGS. 6-8 show the insertion of a spatula with a planar
distal tip into the facet joint.
[0033] FIG. 9 depicts insertion of the drill guide over the
spatula.
[0034] FIG. 10 depicts the alignment of markings on a spatula and
drill guide to match the orientation of the distal ends of these
tools.
[0035] FIG. 11 shows the drill guide in position following removal
of the surgical pin and/or spatula with a drill bit ready for
insertion into the drill guide.
[0036] FIG. 12 shows an enlarged view of insertion of a drill bit
into the drill guide.
[0037] FIG. 13 shows an enlarged view the distal tip of a bone plug
inserter with a bone plug ready for deployment.
[0038] FIG. 14 shows the bone plug inserter of FIG. 13 ready for
insertion through the drill guide.
[0039] FIG. 15 represents the tamping or hammering of the proximal
end of the inserter once inserted through the drill guide.
[0040] FIG. 16 shows a alternative design of a bone plug inserter
that can be used in accordance with the present invention.
[0041] FIG. 17 shows surgical tools that can be used in accordance
with the present invention in a combination that may be provided in
a surgical kit.
[0042] FIGS. 18 and 19 represent alternate views of holes created
by drilling in the facet joints where bone plugs of the present
invention can be inserted.
[0043] FIG. 20 shows an alternative representation of a hole
prepared for insertion with a bone plug oriented for insertion into
the hole.
[0044] FIG. 21 shows a frustum shaped bone plug of the present
invention that can be used in facet joint fusion.
[0045] FIG. 22 shows a bone plug inserted in the hole of FIG. 20
with an application tube for inserting synthetic or biologic
material into the facet joint.
[0046] FIG. 23 is a cross-section depiction of FIG. 22.
[0047] FIG. 24 shows a second alternative frustum shaped bone
plug.
[0048] FIGS. 25-29 show a variety of bone plugs in with different
configurations of fins, flanges and/or ridges.
DETAILED DESCRIPTION OF THE INVENTION
[0049] It is understood that the present invention is not limited
to the particular methodologies, protocols, systems and methods,
etc., described herein, as these may vary. It is also to be
understood that the terminology used herein is used for describing
particular embodiments only, and is not intended to limit the scope
of the present invention. It must be noted that as used herein and
in the appended claims, the singular forms "a," "an," and "the"
include the plural reference unless the context clearly dictates
otherwise. For instance, a reference to a surgical kit refers to
one or more surgical kits and a reference to "a method" is a
reference to one or more methods and includes equivalents thereof
known to those of ordinary skill in the art and so forth.
[0050] Unless defined otherwise, all technical and scientific terms
used herein have the same meanings as commonly understood by one of
ordinary skill in the art to which this invention belongs. Specific
methods, devices, systems and materials are described, although any
methods and materials similar or equivalent to those described
herein can be used in the practice or testing of the present
invention.
[0051] Back pain is a prevalent problem in the United States. One
root cause of back pain, particularly the persistent and disabling
kind, is problems with facet joints. Each vertebra has two sets of
facet joints. One pair faces upward and the other pair faces
downward. Within each set there is a facet joint on the left side
of each vertebra and a facet joint on the right side of each
vertebra.
[0052] Facet joints, also called zygapophyseal or apophyseal joints
are the system of joints that allow movement (forward bending,
backward bending and twisting) of the spine. While these joints
allow movement of the spine, their interlocking nature also helps
to stabilize the spine.
[0053] Similar to other joints in the body, each facet joint is
surrounded by a capsule of connective tissue and produces synovial
fluid to nourish and lubricate the joint. The joint surfaces
themselves are coated with a thick spongy material called articular
cartilage that enables the bones of each joint to smoothly move
against the other.
[0054] Osteoarthritis is one cause of facet joint pain. This
degenerative disease causes progressive cartilage deterioration.
Without the spongy cartilaginous cushion, joint bones rub against
each other when at rest and during movement causing a substantial
amount of pain. Therefore, one option to treat this type of pain is
to join rubbing portions of bone together so that this painful
friction does not occur.
[0055] The present invention provides a minimally-invasive surgical
option and associated tools to fuse facet joints for the treatment
of back pain. The methods and tools can be used to perform the
joint fusion in a minimally invasive procedure, for example
arthroscopically or percutaneously, in some instances, leading to
an out-patient procedure. In one embodiment, the methods and tools
can be used to fuse the forty-eight spinal facet joints on the
spine from C1-C2 through L5-S1.
[0056] Turning to the Figures, FIG. 1 represents a first step in
the presently-described procedure. In this step, following the
creation of a small incision, the distal tips 10 of surgical pins
20 are used to locate facet joints 30. FIG. 2 depicts an
alternative view of FIG. 1 showing the location of facet joints 30
with distal ends 10 of pins 20.
[0057] Once the facet joint 30 has been located with the distal end
of a pin 20, as seen in FIG. 3, a substantially hollow drill guide
40 can be slid over the pin 20. The drill guide 40 can reach the
facet joint 30 through progressive dilation of the intervening soft
tissue (note, however, that the instrument design does not preclude
its use in a classic open surgery or by access to the facet joint
through an otherwise limited incision).
[0058] FIG. 4 depicts an enlarged view of the distal end of the
drill guide within a facet joint 30. The distal end of the drill
guide 40 can have one of more teeth 50. In certain embodiments, the
distal end of the drill guide 40 has two larger teeth 50 (FIG. 5)
that are separated by about 180.degree. around the circumference of
the distal end of the drill guide 40. In certain embodiments, the
drill guide 40 can have a marking that indicates the rotational
orientation of these two teeth 50. One or more smaller teeth 60 may
also be found between or surrounding the larger teeth 50. In
general, the two larger teeth 50 may be inserted into the facet
joint 30 as shown in FIGS. 3, 4 and 5. To achieve this insertion,
the distal end of the drill guide 40 may simply be inserted into
the facet joint 30. Alternatively or in combination, the handle 70
of the drill guide 40 may be tapped or hammered with a surgical
hammer 80 to achieve insertion of the distal end of the drill guide
into the facet joint 30.
[0059] In a particular embodiment of the present invention, there
can be an intermediate step between locating the facet joint 30
with the distal end 10 of a pin 20 and inserting the drill guide 40
over the pin 20. In this alternative embodiment, depicted in FIGS.
6-8, a substantially hollow spatula 90 is inserted over the pin 20.
The distal end of the spatula 90 can have a planar wedge 105 that
can be inserted into the facet joint 30. The spatula 90 may also
have a marking 115 that can indicate the orientation of the planar
wedge once inserted into the body. In this embodiment, and as shown
in FIG. 9, after the planar wedge of the spatula 90 is inserted
into the facet joint 30, the drill guide 40 can be inserted over
the spatula 90. When both the spatula 90 and the drill guide 40 are
inserted, the markings on each 125 can be aligned so that the
rotational orientation of the drill guide's two larger teeth 50 is
in approximately the same plane defined by the spatula's planar
wedge (FIGS. 9 and 10). If the planar wedge of the spatula 90 is
inserted into the facet joint 30, then lining up the markings 125
on the spatula 90 and drill guide 40 will place the drill guide's
two larger teeth 50 in the proper orientation to also enter the
facet joint 30. Once aligned in this manner, the two larger teeth
50 can simply be inserted into the facet joint 30. Alternatively,
or in combination, and as shown in FIG. 9, a surgical hammer 80 or
other appropriate tool may be used to tap or hammer the drill guide
40 into place within the facet joint 30.
[0060] Regardless of whether spatula 90 is used, following
insertion of the distal end of the drill guide 40 into the facet
joint 30, the pin 20 and/or spatula 90 can be removed from the
substantially hollow inner portion of the drill guide 40. Following
this removal, an appropriately-sized drill bit 100 is inserted
through the substantially hollow portion of the drill guide 40. The
drill bit 100 is used to create a hole between the bones 35 of
facet joint 30 (see FIGS. 11 and 12). In some embodiments, the
drill bit drills the hole in a manner that permits at least some of
the drilled bone to remain in the hole. In some such embodiments,
the drill grinds the drilled bone into a powder as it creates the
hole. In some such embodiments, the drill bit compacts the drilled
bone into the bone forming the hole. This compacted bone that
remains in the drilled hole may help fusion of the facet joint by
facilitating bone growth within the hole. The described drill bit
(a punch could also be used) includes any number of components
capable of performing the creation of a hole through both sides of
the spinal facet joint.
[0061] As shown in FIG. 14, following the creation of a hole in the
facet joint 30 a bone plug inserter 135 can be used to place a bone
plug 145 into the hole. FIG. 13 shows an enlarged view of the
distal end of a bone plug inserter 135 and its associated bone plug
145. As shown in FIG. 15, the bone plug 145 can simply be inserted
into the facet joint 30, or, alternatively, or in combination, a
surgical hammer 80 or other appropriate tool may be used to tap or
hammer the bone plug inserter 135 to fix the bone plug 145 within
the facet joint 30. Furthermore, any number of additional
components capable of pushing and/or compressing a bone plug 145
into the hole can additionally be used. In certain particular
embodiments, a suture or metallic overlay can also be applied to
provide additional structural stability to the joint during bone
plug 145 incorporation.
[0062] A specific embodiment of a bone plug inserter 135 is
depicted in FIG. 16. In this embodiment, bone plug inserter 135
comprises a raised portion 200 at or near its proximal end. Raised
portion 200 has dimensions that are greater than those of elongate
portion 210. For example, in an embodiment where bone plug inserter
135 is substantially cylindrical, raised portion 200 may have a
diameter greater than that of elongate portion 210. Raised portion
200 is configured to interact with the proximal portion of drill
guide 40 in a manner that prevents passage of raised portion 200
into the substantially hollow portion of the drill guide 40. In a
specific embodiment, the distal edge or surface of raised portion
200 at lip or ridge 205 contacts the proximal end of the drill
guide 40. This configuration minimizes the chances of
over-insertion of bone plug 110 into hole 28 and related damage.
Over insertion in this context includes insertion of the bone plug
110 into hole to an extent that may cause damage to the bone plug
110, hole 28, or any portion of the facet joint. In some
embodiments, over insertion occurs where the bone plug 110 is
inserted to an extent that causes the distal end of the bone plug
110 to extend beyond the facet joint or proximal end of the bone
plug 110 to be below the surface of the facet joint. Raised portion
200 may be any suitable size and configuration. For example, raised
portion 200 may simply be a post or other structure that is
configured to interact with the distal portion of drill guide
40.
[0063] FIG. 17 depicts tools that can be assembled into a surgical
kit of the present invention. The depicted surgical kit includes
pins 20, a spatula 90, a drill guide 40, a surgical hammer 80, a
bone plug inserter 135, an appropriately-sized drill bit 100 and a
bone plug holder 155. The depicted bone plug holder 155 has
openings 165 shaped to hold variously sized or shaped bone plugs.
Other surgical kits according to the present invention can include
different combinations or subsets of these tools in varying numbers
as deemed appropriate for particular needs and uses. Whatever
combination of tools is chosen for a particular surgical kit
according to the present invention, the tools are generally
provided in an autoclavable container such as or similar to that
depicted in FIG. 17. The tools may be configured such that they may
be used in minimally invasive procedures (e.g., arthroscopic or
percutaneous procedures).
[0064] Holes 165 in facet joints created by the previously
described drill bit are depicted in FIGS. 18 and 19. An alternative
depiction of a hole 28 created by a drill bit in a facet joint
between two facet joint bones 130 and 32 is provided in FIG.
20.
[0065] This FIG. 20 also shows one embodiment of a bone plug 110
according to the present invention. This bone plug 110 according to
the present invention has fins or flanges 18 and 120 that can
assist in holding the bone plug 110 within the created hole 28.
Moreover, the depicted bone plug 110 has holes 12, 14 and 16 which
connect channels within the bone plug 110. These holes 12, 14 and
16 and associated channels permit the insertion of synthetic or
biologic materials into and around bone plug 110 following its
placement within the facet joint.
[0066] The bone plug 110 depicted in FIG. 20 is also shown in an
enlarged alternative perspective in FIG. 21. This depicted bone
plug 110 includes an inverted frustum shape with a pair of opposed
fins or flanges 18 and 120 on the same plane that can partially
circumvent the bone plug 110 near bottom end 22 which has a smaller
diameter than the top end 24. In certain embodiments according to
the present invention, the distal end 22 of the bone plug 110 can
be about 3 mm to about 8 mm in diameter and the proximal end 24 of
the bone plug can be about 4 mm to about 12 mm in diameter. This
general shape can be adopted to facilitate fixation during bone
plug incorporation into the facet joint. The procedure is
envisioned to require only one bone plug per facet joint and, if
required, two bone plugs per facet joint level. Permanent fixation
of the bone plugs should occur when bone in-growth occurs into the
joint itself and into the plug over time.
[0067] Still referring to FIG. 21, bone plug 110 has a vertical
central channel extending generally downwardly from opening 12 that
can be used, when desired, for insertion of synthetic and/or
biologic materials. These synthetic and/or biologic materials can
be used for a variety of purposes including, without limitation, to
resist infection, reduce inflammation and/or to assist in fusing
the bone plug 110 in place within the facet joint. As shown, the
bone plug 110 can have multiple channel openings 12, 14 and 16 on
its surface that can be used to deliver the synthetic and/or
biologic materials to various locations of the facet joint. The
depicted bone plug 110 also includes a fin or flange 18 as an
optional anti-migration feature. The depicted bone plug 110 also
includes fins or flanges 18, 120 as optional anti-migration
features.
[0068] FIG. 22 shows a bone plug 110 inserted into a facet joint
between facet joint bones 130, 32. A synthetic and/or biologic
material delivery device 34 that can be used to administer the
chosen synthetic and/or biologic materials is also shown. FIG. 22
depicts a cross section of this bone plug within the facet joint.
As shown, an application tube 34 can be placed over the top of
and/or inserted into a channel that extends generally downwardly
from opening 12 to permit insertion of synthetic and/or biologic
materials 36 into bone plug 110. When administered, the synthetic
and/or biologic materials 36 can flow down the channel associated
with opening 12 and into channels 42 and 44 and excess synthetic
and/or biologic material will flow out of openings 14 and 16
respectively, into a space 38 between the bones 130 and 32, and an
exterior side wall 40 of the bone plug 110. Again, and in this
particular embodiment, flanges 18 and 120 can act as fins or
flanges to hold the bone plug 110 in place within the facet joint
hole.
[0069] FIG. 24 shows an alternative bone plug 175 of the present
invention. This bone plug 175 is similar to that previously
described except that the bone plug 175 does not include channels
for the delivery of synthetic and/or biologic materials or flanges.
As should be understood by reference to FIG. 24, bone plugs
according to the present invention are not required to adopt these
features as they are not required to successfully practice the
methods of the present invention. FIG. 24 shows another alternative
bone plug 185 according to the present invention. This embodiment
includes four fins or flanges 18, 120, 186, 187. FIGS. 26-29 show a
variety of other bone plug designs for use in accordance with the
present invention. Each design includes a different non-limiting
example of a configuration of shapes, fins, flanges and/or ridges
as features that can be used and incorporated into the bone plugs
used with the present invention.
[0070] As should be understood by one of ordinary skill in the art,
a bone plug of any appropriate shape, size or number of fins or
flanges can be used in accordance with the present invention,
including a bone plug without fins, ridges, flanges or other such
structures.
[0071] Bone plugs according to the present invention can be formed
of any suitable material. It should be understood that while the
plugs according to the present invention are consistently referred
to as "bone" plugs, they need not be formed out of bone in all
circumstances. The key feature of these bone plugs is that they are
formed of a material allowing bone in-growth and fixation over
time. In some embodiments, the bone plugs of the present invention
can be formed at least in part of any of the following: synthetic
cortical bone, a harvested compacted synthetic iliac crest graft,
an autologous allograft, a cadaveric allograft, autografts, bone
substitutes such as coral granules or hydroxyapatite crystals, a
trabecular or porous metal, a metal graft, synthetic iliac crest
graft, a xenograft, synthetic graft, cortico-cancellous graft, and
bone morphogenic proteins. In some embodiments, the bone plugs may
also include or comprise proteins that enhance or promote bone
growth. In one embodiment, the hole created in a facet joint can be
filled with the patient's own harvested and compacted bone plug
using iliac crest autograft. In other embodiments, the hole created
in a facet joint can be filled with a pre-made, pre-shaped cortical
cadaveric allograft (the autograft or allograft formed by bone plug
press or machining). In further embodiments, the hole created in a
facet joint can be filled with a FDA approved pre-made, pre-shaped
synthetic graft.
[0072] In some embodiments, the bone plugs may include
biocompatible granules, which are a hard substance that provides
structural support or physiological advantages to the implant mass.
The biocompatible granules can be made of synthetic, naturally
occurring, polymeric, or non-polymeric materials. In one
embodiment, the granules are also biodegradable such that the
implant degrades over time and may be replaced with native bone
tissue. The biocompatible granules of the present invention can be
made of a synthetic, biocompatible material, such as biopolymers,
bioglasses, bioceramics, calcium sulfate, silicon oxide, calcium
phosphate such as, for example, monocalcium phosphate monohydrate,
monocalcium phosphate anhydrous, dicalcium phosphate dihydrate,
dicalcium phosphate anhydrous, tetracalcium phosphate, calcium
orthophosphate phosphate, calcium pyrophosphate, .alpha.-tricalcium
phosphate, .beta.-tricalcium phosphate (.beta.-TCP), apatite such
as hydroxyapatite (HA), or polymers such as, for example,
poly(.alpha.-hydroxyesters), poly(ortho esters), poly(ether
esters), polyanhydrides, poly(phosphazenes), poly(propylene
fumarates), poly(ester amides), poly(ethylene fumates), poly(amino
acids), polysaccharides, polypeptides, poly(hydroxy butyrates),
poly(hydroxy valerates), polyurethanes, poly(malic acid),
polylactides, polyglycolides, polycaprolactones,
poly(glycolide-co-trimethylene carbonates), polydioxanones, or
co-polymers, terpolymers thereof or blends of those polymers, or a
combination of biocompatible and biodegradable materials.
[0073] The following materials can also be used as a structural
component in the bone plugs of the present invention and are
considered to be synthetic materials: Chitin and chitosan, which
may be derived form tissues of marine non-vertebrate animals;
hyaluronic acid, a polysaccharide, which can be obtained from
rooster comb or by micro-organism fermentation; poly(amino acids)
and polypeptides, which may be produced by biotechnological
processes; any polysaccharide, which is obtained from plants, from
non-vertebrate animals or by biotechnological processes (e.g.
alginate).
[0074] Calcium phosphate ceramics are biocompatible and can be used
in various biomedical applications. HA and .beta.-TCP bioceramics
are particularly useful materials because they have similar ionic
properties as the mineral components of bone. In addition, their
resorption kinetics can be controlled to meet the needs of a
specific therapy. Furthermore, because .beta.-TCP is biodegradable,
it is absorbed in vivo and can be replaced with new bone
growth.
[0075] Other equivalent elements can be substituted for the
elements disclosed herein to produce substantially the same results
in substantially the same way.
[0076] It is anticipated that the availability of the methods and
surgical kits described herein will dramatically increase the
number of surgeries performed because they can offer the first safe
outpatient surgical solution to the predominant cause of spinal
joint pain. It is expected that many patients receiving this
procedure will be able to walk out the same day and be fully
functional within a few weeks. Present surgical solutions require
hospitalization of about three days and six to twenty-four months
recovery.
[0077] Aside from the obvious positive clinical outcome, the
significant favorable financial impact on disability, worker's
compensation and health care insurers is considerable. First, the
present invention provides a minimally invasive surgery that often
can be performed in an outpatient setting as opposed to major
surgery performed in a hospital. This procedure can also be
performed during open surgery if the facet joints need to be fused
as determined by a physician particularly in conjunction with
instrumented vertebral fusion. Second, recovery times are estimated
to be a few weeks as opposed to 6 to 12 months, and finally, the
present invention is directed at overcoming, or at least improving
upon, the disadvantages of the prior art by achieving the
following: reduced morbidity; reduced blood loss; reduced time
under anesthesia; reduced risk; reduced recovery time; reduced risk
of post-operative infection; and minimal scarring that decreases
the risk of failed back syndrome and improves revision surgery
outcome. Furthermore, the present invention does not preclude other
surgical or non-invasive treatment options.
[0078] While specific embodiments of the present invention have
been described, other and further modifications and changes may be
made without departing from the spirit of the invention. All
further and other modifications and changes are included that come
within the scope of the invention as set forth in the claims. The
disclosures of all publications cited above are expressly
incorporated by reference in their entireties to the same extent as
if each were incorporated by reference individually.
* * * * *