U.S. patent application number 13/027855 was filed with the patent office on 2011-08-18 for devices and methods for annular repair of intervertebral discs.
This patent application is currently assigned to Anulex Technologies, Inc.. Invention is credited to Robert E. Atkinson, Peter T. Keith.
Application Number | 20110202137 13/027855 |
Document ID | / |
Family ID | 33314561 |
Filed Date | 2011-08-18 |
United States Patent
Application |
20110202137 |
Kind Code |
A1 |
Keith; Peter T. ; et
al. |
August 18, 2011 |
DEVICES AND METHODS FOR ANNULAR REPAIR OF INTERVERTEBRAL DISCS
Abstract
Devices and methods for treating a damaged intervertebral disc
to reduce or eliminate associated back pain. The present invention
provides disc reinforcement therapy (DRT) which involves implanting
one or more reinforcement members in and preferably around the
annulus of the disc. The reinforcement members may be used to
stabilize the annulus and/or compresses a portion of the annulus so
as to reduce a bulge and/or close a fissure. The implantable
devices and associated delivery tools may incorporate heating
capabilities to thermally treat the annular tissue. Alternatively
or in combination, other devices may be specifically employed for
such thermal treatment.
Inventors: |
Keith; Peter T.; (Lanesboro,
MN) ; Atkinson; Robert E.; (Stillwater, MN) |
Assignee: |
Anulex Technologies, Inc.
Minnetonka
MN
|
Family ID: |
33314561 |
Appl. No.: |
13/027855 |
Filed: |
February 15, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11753682 |
May 25, 2007 |
7905923 |
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13027855 |
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10943525 |
Sep 17, 2004 |
7753941 |
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11753682 |
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10390970 |
Mar 18, 2003 |
6805695 |
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10943525 |
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09685401 |
Oct 10, 2000 |
6579291 |
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10390970 |
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10055780 |
Jan 22, 2002 |
6689125 |
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09685401 |
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10093990 |
Mar 7, 2002 |
6835205 |
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10390970 |
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09542972 |
Apr 4, 2000 |
6402750 |
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10093990 |
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60263343 |
Jan 22, 2001 |
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60368108 |
Mar 26, 2002 |
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Current U.S.
Class: |
623/17.16 |
Current CPC
Class: |
A61B 2017/00557
20130101; A61F 2002/4435 20130101; A61B 17/842 20130101; A61F
2002/30062 20130101; A61B 2017/00084 20130101; A61F 2210/0004
20130101; A61B 18/08 20130101; A61B 17/8897 20130101; A61F 2/4611
20130101; A61B 17/86 20130101; A61B 17/3468 20130101; A61B
2017/0409 20130101; A61B 2017/00261 20130101; A61F 2310/00017
20130101; A61F 2/442 20130101; A61F 2002/30579 20130101; A61B 18/14
20130101; A61F 2002/30841 20130101; A61B 17/3472 20130101; A61F
2002/4627 20130101; A61F 2310/00976 20130101; A61F 2210/0023
20130101; A61B 17/0401 20130101; A61F 2002/30092 20130101; A61B
17/1671 20130101; A61F 2310/00023 20130101; A61B 2090/037
20160201 |
Class at
Publication: |
623/17.16 |
International
Class: |
A61F 2/44 20060101
A61F002/44 |
Claims
1. A biocompatible implant adapted to augment, reinforce, or
otherwise repair an intervertebral disc defect.
2. The implant of claim 1 comprising a resiliently compressible
material.
3. The implant of claim 1 comprising an elastic material.
4. The implant of claim 1 comprising a polymer.
5. A system for treating an intervertebral defect, comprising the
implant of claim 1 and a delivery device.
6. The system of claim 5, wherein said delivery device comprises at
least one tube having a lumen and an advancer.
7. An apparatus for securing an implant for treating intervertebral
disc disease, comprising: an anchor portion coupled to the implant
and adapted to be implanted and fixed into annular tissue, the
anchor portion having an implantation position and a fixation
position, the anchor portion being resistive to expulsion from the
annular tissue when in a fixation position.
8. The apparatus of claim 7, wherein the anchor portion comprises
at least one anchor mechanism adapted to resist expulsion.
9. The apparatus according to claim 7, wherein the anchor portion
is formed integral to the implant.
10. The apparatus according to claim 7, wherein the anchor portion
comprises one or more anchor mechanisms that project into annular
tissue when the anchor portion is in the fixation position.
11. The apparatus according to claim 10, wherein the anchor portion
is at least partially collapsed when the anchor portion is in the
implantation position and at least partially expanded when the
anchor portion is in the fixation position.
12. A method for treating intervertebral disc disease in a patient,
the method comprising: (1) providing a biocompatible implant
adapted to obliterate an intervertebral disc defect, said implant
comprising an apparatus for securing said implant having an anchor
portion coupled to the implant and adapted to be implanted and
fixed into annular tissue, said anchor portion having an
implantation position and a fixation position, and said anchor
portion being resistive to expulsion from the annular tissue when
in a fixation position; a delivery device comprising at least one
tube having a lumen; and an advancer; (2) inserting said delivery
device into an intervertebral disc of a patient; (3) delivering
said implant into a therapeutically effective location with said
anchor portion of said implant in an implantation position; and (4)
engaging said anchor portion of said implant to a fixation
position, thereby fixing said implant into annular tissue.
13. The method for treating intervertebral disc disease of claim
12, wherein the implantation position of said anchor portion of
said implant is an at least partially collapsed position.
14. The method for treating intervertebral disc disease of claim
12, wherein the fixation position of said anchor portion of said
implant is an at least partially expanded position.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] The present application is a continuation of U.S.
application Ser. No. 11/753,682, filed May 25, 2007; which is a
continuation of U.S. application Ser. No. 10/943,525 filed Sep. 17,
2004, now U.S. Pat. No. 7,753,941; which is a continuation of U.S.
application Ser. No. 10/390,970, filed Mar. 18, 2003, now U.S. Pat.
No. 6,805,695; and is a continuation-in-part of Ser. No.
10/055,780, filed Jan. 22, 2002, now U.S. Pat. No. 6,689,125; and
is a continuation-in-part of Ser. No. 09/685,401, filed Oct. 10,
2000, now U.S. Pat. No. 6,579,291; and is a continuation-in-part of
Ser. No. 10/093,990, filed Mar. 7, 2002, now U.S. Pat. No.
6,835,205; which is a continuation of Ser. No. 09/542,972, filed
Apr. 4, 2000, now U.S. Pat. No. 6,402,750; and claims the benefit
of U.S. Provisional Application No. 60/263,343, filed Jan. 22,
2001; and claims the benefit of U.S. Provisional Application No.
60/368,108 filed Mar. 26, 2002 entitled DEVICES AND METHODS FOR THE
TREATMENT OF SPINAL DISORDERS, the entire disclosure of which is
incorporated herein by reference.
TECHNICAL FIELD
[0002] The present invention generally relates to devices and
methods for the repair of intervertebral discs. Specifically, the
present invention relates to devices and methods for the treatment
of spinal disorders associated with the annulus of an
intervertebral disc.
BACKGROUND
[0003] Back pain is one of the most common and often debilitating
conditions affecting millions of people in all walks of life.
Today, it is estimated that over ten million people in the United
States alone suffer from persistent back pain. Approximately half
of those suffering from persistent back pain are afflicted with
chronic disabling pain, which seriously compromises a person's
quality of life and is the second most common cause of worker
absenteeism. Further, the cost of treating chronic back pain is
very high, even though the majority of sufferers do not receive
treatment due to health risks, limited treatment options and
inadequate therapeutic results. Thus, chronic back pain has a
significantly adverse effect on a person's quality of life, on
industrial productivity, and on heath care expenditures.
[0004] Some forms of back pain are muscular in nature and may be
simply treated by rest, posture adjustments and painkillers. For
example, some forms of lower back pain (LBP) are very common and
may be caused by unusual exertion or injury. Unusual exertion such
has heavy lifting or strenuous exercise may result in back strain
such as a pulled muscle, sprained muscle, sprained ligament, muscle
spasm, or a combination thereof. An injury caused by falling down
or a blow to the back may cause bruising. These forms of back pain
are typically non-chronic and may be self-treated and cured in a
few days or weeks.
[0005] Other types of non-chronic back pain may be treated by
improvements in physical condition, posture and/or work conditions.
For example, being pregnant, obese or otherwise significantly
overweight may cause LBP. A mattress that does not provide adequate
support may cause back pain in the morning. Working in an
environment lacking good ergonomic design may also cause back pain.
In these instances, the back pain may be cured by eliminating the
culprit cause. Whether it is excess body weight, a bad mattress, or
a bad office chair, these forms of back pain are readily
treated.
[0006] However, some forms of back pain are the result of disorders
directly related to the spinal column, which are not readily
treated. While some pain-causing spinal disorders may be due to
facet joint degradation or degradation of individual vertebral
masses, disorders associated with the intervertebral discs are
predominantly affiliated with chronic back pain (referred to as
disc related pain). The exact origin of disc related pain is often
uncertain, and although some episodes of disc related pain may be
eased with conservative treatments such as bed-rest and physical
therapy, future episodes of disc related pain are likely to occur
periodically.
[0007] There are a number of suspected causes of disc related pain,
and in any given patient, one or more of these causes may be
present. However, the ability to accurately diagnose a specific
cause or locus of pain is currently difficult. Because of this
uncertainty, many of the causes of disc related pain are often
lumped together and referred to as degenerative disc disease
(DDD).
[0008] A commonly suspected source of disc related pain is physical
impingement of the nerve roots emanating from the spinal cord. Such
nerve root impingement may have a number of different underlying
causes, but nerve root impingement generally results from either a
disc protrusion or a narrowing of the intervertebral foramina
(which surround the nerve roots).
[0009] As a person ages, their intervertebral discs become
progressively dehydrated and malnourished. Together with continued
stressing, the disc begins to degenerate. With continued
degeneration, or an excessive stressing event, the annulus fibrosus
of the disc may tear, forming one or more fissures (also referred
to as fractures). Such fissures may progress to larger tears which
allow the gelatinous material of the nucleus pulposus to flow out
of the nucleus and into the outer aspects of the annulus. The flow
of the nucleus pulposus to the outer aspects of the annulus may
cause a localized bulge.
[0010] When bulging of the annulus occurs in the posterior portions
of the disc, the nerve roots may be directly and physically
impinged by the bulge. In more extreme or progressed instances of
annular tears, the nuclear material may escape, additionally
causing chemical irritation of the nerve roots. Depending on the
cause and nature of the disc protrusion, the condition may be
referred to as a disc stenosis, a disc bulge, a herniated disc, a
prolapsed disc, a ruptured disc, or, if the protrusion separates
from the disc, a sequestered disc.
[0011] Dehydration and progressive degeneration of the disc also
leads to thinning of the disc. As the height of the disc reduces,
the intervertebral foraminae become narrow. Because the nerve roots
pass through the intervertebral foraminae, such narrowing may
mechanically entrap the nerve roots. This entrapment can cause
direct mechanical compression, or may tether the roots, allowing
them to be excessively tensioned during body movements.
[0012] Nerve root impingement most often occurs in the lumbar
region of the spinal column since the lumbar discs bear significant
vertical loads relative to discs in other regions of the spine. In
addition, disc protrusions in the lumbar region typically occur
posteriorly because the annulus fibrosus is radially thinner on the
posterior side than on the anterior side and because normal posture
places more compression on the posterior side. Posterior
protrusions are particularly problematic since the nerve roots are
posteriorly positioned relative to the intervertebral discs. Lower
back pain due to nerve root irritation not only results in strong
pain in the region of the back adjacent the disc, but may also
cause sciatica, or pain radiating down one or both legs. Such pain
may also be aggravated by such subtle movements as coughing,
bending over, or remaining in a sitting position for an extended
period of time.
[0013] Another suspected source of disc related back pain is damage
and irritation to the small nerve endings which lie in close
proximity to or just within the outer aspects of the annulus of the
discs. Again, as the disc degenerates and is subjected to stressing
events, the annulus fibrosus may be damaged forming fissures. While
these fissures can lead to pain via the mechanisms described above,
they may also lead to pain emanating from the small nerve endings
in or near the annulus, due to mechanical or chemical irritation at
the sites of the fissures. The fissures may continue to irritate
the small nerve endings, as their presence cause the disc to become
structurally weaker, allowing for more localized straining around
the fissures. This results in more relative motion of edges of the
fissures, increasing mechanical irritation. Because it is believed
that these fissures have only limited healing ability once formed,
such irritation may only become progressively worse.
[0014] A common treatment for a disc protrusion is discectomy, a
procedure wherein the protruding portion of the disc is surgically
removed. However, discectomy procedures have an inherent risk since
the portion of the disc to be removed is immediately adjacent the
nerve root and any damage to the nerve root is clearly undesirable.
Furthermore, discectomy procedures are not always successful long
term because scar tissue may form and/or additional disc material
may subsequently protrude from the disc space as the disc
deteriorates further. The recurrence of a disc protrusion may
necessitate a repeat discectomy procedure, along with its inherent
clinical risks and less than perfect long term success rate. Thus,
a discectomy procedure, at least as a stand-alone procedure, is
clearly not an optimal solution.
[0015] Discectomy is also not a viable solution for DDD when no
disc protrusion is involved. As mentioned above, DDD causes the
entire disc to degenerate, narrowing of the intervertebral space,
and shifting of the load to the facet joints. If the facet joints
carry a substantial load, the joints may degrade over time and be a
different cause of back pain. Furthermore, the narrowed disc space
can result in the intervertebral foramina surrounding the nerve
roots to directly impinge on one or more nerve roots. Such nerve
impingement is very painful and cannot be corrected by a discectomy
procedure. Still furthermore, discectomy does not address pain
caused by the fissures which may cause direct mechanical irritation
to the small nerve endings near or just within the outer aspect of
the annulus of a damaged disc.
[0016] As a result, spinal fusion, particularly with the assistance
of interbody fusion cages, has become a preferred secondary
procedure, and in some instances, a preferred primary procedure.
Spinal fusion involves permanently fusing or fixing adjacent
vertebrae. Hardware in the form of bars, plates, screws and cages
may be utilized in combination with bone graft material to fuse
adjacent vertebrae. Spinal fusion may be performed as a stand-alone
procedure or may be performed in combination with a discectomy
procedure. By placing the adjacent vertebrae in their nominal
position and fixing them in place, relative movement therebetween
may be significantly reduced and the disc space may be restored to
its normal condition. Thus, theoretically, aggravation caused by
relative movement between adjacent vertebrae may be reduced if not
eliminated.
[0017] However, the success rate of spinal fusion procedures is
certainly less than perfect for a number of different reasons, none
of which are well understood. In addition, even if spinal fusion
procedures are initially successful, they may cause accelerated
degeneration of adjacent discs since the adjacent discs must
accommodate a greater degree of motion. The degeneration of
adjacent discs simply leads to the same problem at a different
anatomical location, which is clearly not an optimal solution.
Furthermore, spinal fusion procedures are invasive to the disc,
risk nerve damage and, depending on the procedural approach, either
technically complicated (endoscopic anterior approach), invasive to
the bowel (surgical anterior approach), or invasive to the
musculature of the back (surgical posterior approach).
[0018] Another procedure that has been less than clinically
successful is total disc replacement with a prosthetic disc. This
procedure is also very invasive to the disc and, depending on the
procedural approach, either invasive to the bowel (surgical
anterior approach) or invasive to the musculature of the back
(surgical posterior approach). In addition, the procedure may
actually complicate matters by creating instability in the spine,
and the long term mechanical reliability of prosthetic discs has
yet to be demonstrated.
[0019] Many other medical procedures have been proposed to solve
the problems associated with disc protrusions. However, many of the
proposed procedures have not been clinically proven and some of the
allegedly beneficial procedures have controversial clinical data.
From the foregoing, it should be apparent that there is a
substantial need for improvements in the treatment of spinal
disorders, particularly in the treatment of disc related pain
associated with a damaged or otherwise unhealthy disc.
SUMMARY
[0020] The present invention addresses this need by providing
improved devices and methods for the treatment of spinal disorders.
The improved devices and methods of the present invention
specifically address disc related pain, particularly in the lumbar
region, but may have other significant applications not
specifically mentioned herein. For purposes of illustration only,
and without limitation, the present invention is discussed in
detail with reference to the treatment of damaged discs in the
lumbar region of the adult human spinal column.
[0021] As will become apparent from the following detailed
description, the improved devices and methods of the present
invention may reduce if not eliminate back pain while maintaining
near normal anatomical motion. Specifically, the present invention
provides disc reinforcement devices to reinforce a damaged disc,
while permitting relative movement of the vertebrae adjacent the
damaged disc. The devices of the present invention are particularly
well suited for minimally invasive methods of implantation.
[0022] The reinforcement devices of the present invention may
provide three distinct functions. Firstly, the reinforcement
devices may mechanically stabilize and strengthen the disc to
minimize if not eliminate chronic irritation of nerve roots and
nerves around the periphery of the disc annulus. Secondly, the
reinforcement devices may radially and/or circumferentially
compress the disc to close fissures, fractures and tears, thereby
preventing the ingress of nerves as well as potentially
facilitating healing. Thirdly, the reinforcement devices may be
used to stabilize the posterior disc after a discectomy procedure
in order to reduce the need for re-operation.
[0023] In an exemplary embodiment, the present invention provides
disc reinforcement therapy (DRT) in which a reinforcement member is
implanted in the annulus of an intervertebral disc. The
implantation method may be performed by a percutaneous procedure or
by a minimally invasive surgical procedure. The present invention
provides a number or tools to facilitate percutaneous implantation.
One or more reinforcement members may be implanted, for example,
posteriorly, anteriorly, and/or laterally, and may be oriented
circumferentially or radially. As such, the reinforcement members
may be used to stabilize the annulus and/or compresses a portion of
the annulus so as to reduce a bulge and/or close a fissure.
[0024] In other embodiments, the implantable devices and associated
delivery tools may incorporate heating capabilities to thermally
treat the annular tissue. Alternatively or in combination, other
devices may be specifically employed for such thermal treatment,
and such thermal treatment may be applied by a device that is
temporarily inserted into the annulus, or the thermal treatment may
be applied by a chronically implanted device, either acutely or
chronically.
BRIEF DESCRIPTION OF THE DRAWINGS
[0025] FIGS. 1A and 1B illustrate left lateral and posterior views,
respectively, of a portion of the adult human vertebral (spinal)
column;
[0026] FIGS. 2A and 2B illustrate superior (top) views of a healthy
disc and a degenerated disc, respectively, and an adjacent
vertebral body;
[0027] FIGS. 3A-3F schematically illustrate superior (top) views of
reinforcement members disposed in degenerated discs;
[0028] FIGS. 4A-4M schematically illustrate various features that
may be incorporated into a straight or curved reinforcement member
in accordance with an embodiment of the present invention;
[0029] FIGS. 5A-5C schematically illustrate a circumferential
reinforcement member in accordance with an embodiment of the
present invention;
[0030] FIGS. 6A-6H schematically illustrate components of a
reinforcement member in accordance with an embodiment of the
present invention;
[0031] FIGS. 7A-7F illustrate tools of the present invention for
implanting the reinforcement members shown in FIGS. 3A and 3B in
accordance with the method illustrated in FIGS. 8A-8L;
[0032] FIGS. 8A-8L illustrate a method for implanting the
reinforcement members shown in FIGS. 3A and 3B in accordance with
an embodiment of the present invention;
[0033] FIGS. 9A-9F illustrate tools of the present invention for
implanting the reinforcement member shown in FIG. 3C in accordance
with the method illustrated in FIGS. 10A-10H;
[0034] FIGS. 10A-10H illustrate a method for implanting the
reinforcement member shown in FIG. 3C in accordance with an
embodiment of the present invention;
[0035] FIGS. 11A-11H illustrate a method for implanting the
reinforcement member shown in FIG. 3D in accordance with an
embodiment of the present invention;
[0036] FIGS. 12A-12G and 13-15 illustrate various tools of the
present invention for implanting the reinforcement member shown in
FIGS. 3E and 3F in accordance with the method illustrated in FIGS.
18A-18L;
[0037] FIGS. 16A-16E illustrate a column support and advancement
device for use with the tools illustrated in FIGS. 12A-12G and
13;
[0038] FIGS. 17A-17D illustrate an alternative column support and
advancement device for use with the tools illustrated in FIGS.
12A-12G and 13;
[0039] FIGS. 18A-18L illustrate a method for implanting the
reinforcement member shown in FIGS. 3E and 3F in accordance with an
embodiment of the present invention;
[0040] FIGS. 19A-19F illustrate various possible implant
orientations of the reinforcement member shown in FIGS. 3E and
3F;
[0041] FIGS. 20A-20J illustrate steps for implanting a
self-expanding reinforcement member;
[0042] FIGS. 20K-20L illustrate steps for implanting an inflatable
reinforcement member;
[0043] FIGS. 20M-20R illustrate steps for implanting a
reinforcement bar;
[0044] FIGS. 21A-21C illustrate a reinforcement member in
accordance with an alternative embodiment of the present
invention;
[0045] FIGS. 22A-22D illustrate a reinforcement member in
accordance with yet another alternative embodiment of the present
invention;
[0046] FIGS. 23A and 23B illustrate an alternative method for
implanting a variation of the reinforcement member shown in FIGS.
20J in accordance with an embodiment of the present invention;
[0047] FIGS. 24A-24E illustrate various tools of the present
invention for implanting a reinforcement member in accordance with
the method illustrated in FIGS. 25A-25J;
[0048] FIGS. 25A-25J illustrate an alternative method for
implanting a reinforcement member in accordance with an embodiment
of the present invention;
[0049] FIGS. 26A-26G illustrate various tools of the present
invention for implanting a reinforcement member in accordance with
the method illustrated in FIGS. 27A-27H;
[0050] FIGS. 27A-27H illustrate an alternative method for
implanting a reinforcement member in accordance with an embodiment
of the present invention; and
[0051] FIGS. 28A-28C illustrate various heating probes of the
present invention for temporarily heating annular tissue.
DETAILED DESCRIPTION
[0052] The following detailed description should be read with
reference to the drawings in which similar elements in different
drawings are numbered the same. The drawings, which are not
necessarily to scale, depict illustrative embodiments and are not
intended to limit the scope of the invention.
[0053] With reference to FIGS. 1A and 1B, the lower portion of an
adult human vertebral column 10 is illustrated in left lateral and
posterior views, respectively. The upper portion of the vertebral
column 10 includes the thoracic region and the cervical region,
which are not shown for purposes of simplified illustration only.
The lower portion of the vertebral column 10 includes the lumbar
region 12, the sacrum 14 and the coccyx 16. The sacrum 14 and the
coccyx 16 are sometimes collectively referred to as the pelvic
curvature.
[0054] The vertebral column 10 includes an axis of curvature 60
which generally forms a double-S shape when viewed laterally. The
vertebral column 10 also includes a median plane 70 which is a
sagittal plane bisecting the vertebral column 10 into symmetrical
left lateral and right lateral portions. In posterior views, the
median plane 70 appears as a line.
[0055] The lumbar region 12 of the vertebral column 10 includes
five (5) vertebrae 20 (labeled L1, L2, L3, L4 and L5) separated by
intervertebral discs 50. The sacrum 14, which includes five (5)
fused vertebrae 30 (superior vertebra 30 labeled S1), is separated
by a single disc 50 from the coccyx 16, which includes four (4)
fused vertebrae 40. Although not labeled, the intervertebral discs
50 may be referenced by their respective adjacent vertebrae. For
example, the disc 50 between the L4 and L5 lumbar vertebrae 20 may
be referred to as the L4L5 disc. Similarly, the disc 50 between the
L5 lumbar vertebra 20 and the S1 sacral vertebra 30 may be referred
to as the L5S1 disc.
[0056] Although each vertebra 20/30/40 is a unique and irregular
bone structure, the vertebrae 20 of the lumbar region 12 (in
addition to the thoracic and cervical regions) have common
structures. Each vertebra 20 of the lumbar region 12 generally
includes a body portion 21 and a vertebral arch portion 22/23 which
encloses the vertebral foramen (not visible) in which the spinal
cord is disposed. The vertebral arch 22/23 includes two pedicles 22
and two laminae 23. A spinous process 24 extends posteriorly from
the juncture of the two laminae 23, and two transverse processes 25
extend laterally from each lamina 23. Four articular processes
26/27 extend inferiorly 26 and superiorly 27 from the laminae 23.
The inferior articular process 26 rests in the superior articular
process 27 of the adjacent vertebra to form a facet joint 28.
[0057] The five (5) vertebrae 30 of the sacrum 14 are fused
together to form a single rigid structure. The sacrum 14 includes a
median sacral crest 31 which roughly corresponds to the spinous
processes of the vertebrae 30, and two intermediate sacral crests
32 which roughly correspond to the articular processes of the
vertebrae 30. The sacral laminae 33 are disposed between the median
31 and intermediate 32 sacral crests. Two lateral sacral crests 34
are disposed on either side of the sacral foraminae 35. The sacrum
14 also includes a pair of sacral wings 36 which define auricular
surfaces 39. The superior (S1) sacral vertebra 30 includes two
superior articular processes 37 which engage the inferior articular
processes 26 of the L5 lumber vertebra 20 to form a facet joint,
and the base 38 of the superior sacral vertebra S1 is joined to the
L5S1 disc 50.
[0058] With reference to FIG. 2A, each intervertebral disc 50
includes an annulus fibrosus 52 surrounding a nucleus pulposus 54.
The posterior annulus 52 is generally thinner than the anterior
annulus 52, which may account for the higher incidence of posterior
disc protrusions. The annulus fibrosus 52 comprises about 60% of
the total disc 50 cross-sectional area, and the nucleus pulposus 54
only comprises about 40% of the total disc 50 cross-sectional area.
The annulus fibrosus 52 comprises 40-60% organized collagen in the
form of a laminated structure. The nucleus pulposus 54 comprises
18-30% collagen in the form of a relatively homogenous gel.
[0059] A common theory is that each intervertebral disc 50 forms
one support point and the facet joints 28 form two support points
of what may be characterized as a three point support structure
between adjacent vertebrae 20. However, in the lumbar region 12,
the facet joints 28 are substantially vertical, leaving the disc 50
to carry the vast majority of the load. As between the annulus
fibrosus 52 and the nucleus pulposus 54 of the disc 50, it is
commonly believed that the nucleus 54 bears the majority of the
load. This belief is based on the theory that the disc 50 behaves
much like a balloon or tire, wherein the annulus 22 merely serves
to contain the pressurized nucleus 54, and the nucleus 54 bears all
the load. However, this theory is questionable since the annulus
fibrosus 52 comprises 60% of the total disc 50 cross-sectional area
and is made of 40-60% organized collagen in the form of a laminated
structure. By contrast, the nucleus pulposus 54 only comprises 40%
of the total disc 50 cross-section and is made of 18-30% collagen
in the form of a relatively homogenous gel. Thus, a more plausible
theory is that the annulus fibrosus 52 is the primary load bearing
portion of the disc 50.
[0060] With reference to FIG. 2B, the intervertebral discs 50
become progressively dehydrated and malnourished with age. When
combined with continued stressing, the disc begins to degenerate.
With continued degeneration, or an excessive stressing event, the
annulus fibrosus of the disc may tear, forming one or more radial
fissures 56 or circumferential fissures 58, which may progress to
larger tears. Larger tears may allow the gelatinous material of the
nucleus pulposus 54 to flow out of the nucleus and into the outer
aspects of the annulus 52. The flow of the nucleus pulposus 54 to
the outer aspects of the annulus 52 may cause a localized bulge 60.
A posterior bulge 60 may result in direct impingement of a nerve
root (not shown). Nuclear material that escapes through an advanced
tear may cause further mechanical irritation and additionally cause
chemical irritation of a nerve root. A nerve root may also be
compressed or tethered by a narrowing of the intervertebral
foraminae, resulting from a loss in disc height caused by sustained
degeneration of the disc 50. Small nerve endings (not shown) in or
near the perimeter of the annulus 52 may also be mechanically or
chemically irritated at the sites of the fissures 56/58. In all
cases, degeneration of the disc eventually leads to disc related
pain of some origin.
[0061] FIGS. 3A-3F schematically illustrate reinforcement members
100/200/300/600 implanted in a degenerated disc 50. In all
instances, the reinforcement members 100/200/300/600 mechanically
stabilize and strengthen the disc 50 to minimize if not eliminate
chronic irritation of nerve roots and nerves around the periphery
of the disc annulus 52. As can be seen in FIGS. 3A-3F, the
reinforcement members 100/200/300/600 also radially and/or
circumferentially compress the disc 50 to close fissures 56/58,
thereby preventing the ingress of nerves and potentially
facilitating healing. The reinforcement members 100/200/300/600 may
further be used to stabilize the posterior portion of the disc 50
after a discectomy procedure in order to reduce the need for
re-operation.
[0062] FIGS. 3A-3F show examples of where the reinforcement members
100/200/300/600 may be implanted in the annulus 52. However, the
reinforcement members 100/200/300/600 may be implanted in any
portion of the annulus 52 including, without limitation, the
posterior, anterior or lateral portions thereof. Because most disc
related pain is associated with damage to the posterior portion of
the disc 50, the reinforcement members 100/200/300/600 preferably
provide support to the posterior portion of the annulus 52 and
establish anchor points in the lateral and anterior portions of the
annulus 52, or completely encircle the annulus 52. The
reinforcement members 100/200/300/600 may be used individually as
shown in FIGS. 3A and 3C-3F, or in combination as shown in FIG. 3B.
Although not shown, any combination of the different types of
reinforcement members 100/200/300/600 may be utilized.
[0063] The reinforcement members 100/200/300/600 may be oriented
generally parallel to the periphery of the annulus 52 (e.g.,
reinforcement members 100A, 100C, 200, 300, 600), generally radial
to the annulus 52 (e.g., reinforcement member 100B), or any other
orientation suitable for stabilizing and/or compressing the desired
portion(s) of the annulus 52. Generally, the closer the
reinforcement members 100/200/300/600 are to the periphery of the
annulus 52, the greater the amount of support and stabilization
provided to the disc 50. As such, the reinforcement members
100/200/300/600 preferably have a curvature conforming to the
periphery of the annulus 52 such that they may be implanted as
close to the periphery of the annulus 52 as possible. The
reinforcement members 100/200/300/600 may have such a curvature in
the relaxed (zero stress) state, or the curvature may be imparted
by the insertion path or defined by the insertion tools used.
[0064] The reinforcement members 100/200/300/600 may extend across
and close fissures 56/58 as shown, or any other portion of the
annulus 52 to provide compression and stabilization of the disc 50.
Although not shown, the reinforcement members 100/200/300/600 may
extend across or into the nucleus 54. In such a case, it is
preferred that the reinforcement members 100/200/300/600 do not
extend outside the periphery of the annulus 52 in order to reduce
the probability of nuclear material escaping from the outer aspects
of the annulus 52.
[0065] The reinforcement members 100/200/300/600 are sized to fit
within the annulus 52 of a human disc 50. Thus, the collective
diameter and length of the reinforcement members 100/200/300/600
implanted preferably does not exceed the height and
circumference/diameter, respectively, of the annulus 52, depending
on the number and orientation of the reinforcement members
100/200/300/600 implanted. The reinforcement members
100/200/300/600 may be made of a biocompatible material or coated
with a biocompatible material. Suitable structural materials for
the reinforcement members 100/200/300/600 include stainless steel
and super elastic alloys such as nickel titanium. All or a portion
of the reinforcement members 100/200/300/600 may be made of
biodegradable or bioabsorbable material such as resorbable
collagen, LPLA (poly(l-lactide)), DLPLA (poly(dl-lactide)),
LPLA-DLPLA, PGA (polyglycolide), PGA-LPLA or PGA-DLPLA. Other
metals, alloys, polymers, and composites having suitable tensile,
compression and fatigue strength and elasticity may also be used.
The reinforcement members 100/200/300/600 may further include
growth factors to facilitate healing, agents which render nuclear
matter inert or otherwise reduce chemical irritation thereof,
and/or anesthetic agents to reduce nerve signal transmission (i.e.,
pain).
[0066] Reinforcement member 600, as illustrated in FIGS. 3E and 3F,
is adapted to completely encircle the annulus 52 to thereby apply
uniform compressive forces about the periphery of the annulus 52.
The reinforcement member 600 has opposing ends which are secured
together by a permanent connection 610 such as a knot as seen in
FIG. 3E. Optionally, a pledget 750 may be employed as illustrated
in FIG. 3F and as discussed in more detail hereinafter.
Reinforcement member 600 may substantially reside within the
confines of the annulus 52, with the connection 610 and optional
pledget 750 residing within or immediately outside the confines of
the annulus 52. While reinforcement member 600 is shown within the
outer aspect of the annulus 52, it is also contemplated that all or
portions of reinforcement member 600 may be implanted outside the
annulus 52. For example, reinforcement member 600 may be placed in
the tissue plane between the outside of the annulus 52 and external
connective tissues (not shown).
[0067] The reinforcement member 600 may comprise a monofilament or
multifilament structure that resists elongation in tension, but is
otherwise very flexible. For example, the reinforcement member 600
may comprise a polymeric or metallic fiber, cable, thread, suture,
wire, ribbon, or the like. Suitable materials for the
circumferential reinforcement member 600 include, but are not
limited to, commercially available suture materials used in a
variety of surgical procedures. Such exemplary suture materials
include biodegradable suture made from polylactic acid and
polyglycolic acid, and non-degradable materials such as
monofilament and braided polypropylene and polyester (PET). Another
suitable nondegradable suture material is made from expanded
polytetrafluoroethylene (ePTFE). Other materials which are suitable
for the circumferential reinforcement member 600 include braided
ultra-high molecular weight fibers of polyethylene (UHMWPE),
commercially available as Spectra.TM. or Dyneema.TM., as well as
other high tensile strength materials such as Vectran.TM.,
Kevlar.TM., and natural or artificially produced silk.
[0068] As an alternative, the reinforcement member 100/200/300/600
may be designed for temporary heating (post-implantation) to cause
thermal changes to the annulus. Because the annulus is comprised of
overlapping bands of oriented collagen which tend to shrink in the
direction of orientation when heated to temperatures of 50 to 90
degrees centigrade, temporarily heating the reinforcement member
100/200/300/600 causes thermal reformation of the annulus. In
addition, annular defects such as fissures and tears can refuse,
particularly if the edges are brought into apposition prior to or
during the heating step. Such annular defects may be closed (i.e.,
edges brought into apposition) by compression imparted by the
reinforcement member 100/200/300/600 during implantation or by
collagen shrinkage imparted by heating the reinforcement member
100/200/300/600.
[0069] The reinforcement member 100/200/300/600 may be heated by
inducing heat in the material of the reinforcement member
100/200/300/600 or by incorporating one or more heating elements
into the reinforcement member 100/200/300/600. In both cases, a
source of electric or magnetic power (e.g., electric power supply,
magnetic field generator, RF transmitter, etc.) is used to provide
energy to the reinforcement member 100/200/300/600 which converts
the electric/magnetic energy to thermal energy. Such a power source
may be directly or remotely connected to the reinforcement member
100/200/300/600.
[0070] For example, the reinforcement members 100/200/300/600 may
include resistive heating elements directly connected to an
internal (implanted) power supply or directly connected
(transdermal) to an external electric power supply. Alternatively,
the resistive heating elements may be connected to an implanted
receiving antenna which receives a power signal from a remote
external power signal transmitting antenna. As a further
alternative, the reinforcement member 100/200/300/600 may be heated
by remote inductive heating via an external alternating magnetic
field generator. Because significant portions of the reinforcement
member 100/200/300/600 may comprise a conductive metallic material,
the presence of an alternating magnetic field will inductively heat
the reinforcement member 100/200/300/600. Further aspects of these
and other heated reinforcement member 100/200/300/600 embodiments
are discussed in more detail with reference to FIGS. 4H-4M.
[0071] In all embodiments, various visualization techniques may be
used to facilitate implantation of the reinforcement members
100/200/300/600. For example, real time CT scanning, real time MR
imaging, or a combination of preoperative CT or MR images
superimposed onto a real time device tracking images such as the
system commercially available under the trade name STEALTH.TM.
available from Sofamor Danek.
[0072] FIGS. 4A-4K illustrate various embodiments of the
reinforcement member 100 in accordance with the present invention.
The embodiments of FIGS. 4A-4K illustrate various features which
may be combined in any way to provide the desired reinforcement
member 100. Reinforcement member 100 may be sized and oriented as
shown and discussed with reference to FIGS. 3A and 3B.
Reinforcement member 100 includes a body portion 110 and an anchor
120. The anchor 120 serves to immobilize or limit movement of the
reinforcement member 100 relative to the annulus 52.
[0073] In FIGS. 4A, 4D and 4F, the anchor is in the form of threads
122 disposed about the periphery of the body portion 110, which
behave like threads on a screw and engage the annulus 52 upon
rotation therein. When threads 122 are used, the proximal end of
the body 110 may include slots 116 as shown in FIG. 4C, which is an
end view taken along line 4C-4C in FIG. 4A. The slots 116, or any
other suitable mating geometry, facilitate rotation with a driver
having a mating distal end. In FIG. 4E, the anchor 120 is in the
form of sloped rings 124 spaced along the length of the body
portion 110, which behave like rings on a ring-shank nail to engage
the annulus 52 upon pushing therein. Those skilled in the art will
recognize that other anchor 120 mechanisms such as barbs,
expandable anchors, etc. may also be used.
[0074] The anchor 120 may extend the full length of the body
portion 110 as shown in FIGS. 4A and 4F, or may be disposed only on
proximal and distal portions of the body as shown in FIGS. 4D and
4E. The body portion 110 may be tubular defining a lumen 112
extending therethrough as shown in FIG. 4B, which is a
cross-sectional view taken along line 4B-4B in FIG. 4A. The lumen
112 facilitates advancement of the reinforcement member 100 over a
stylet to facilitate insertion into the annulus 52, as will be
discussed in greater detail hereinafter. Alternatively, the body
portion 110 may have a solid cross-section as shown in FIG. 4G,
which is a cross-sectional view taken along line 4G-4G in FIG. 4F.
In this alternative embodiment, the solid cross-section body
portion 110 may include a sharpened distal tip 114 as shown in FIG.
4F to facilitate insertion into the annulus 52.
[0075] Preferably, the threads 122 have a variable pitch such that
the annulus is compressed as the reinforcement member 100 is
rotated and advanced into the annulus 52. Variable pitch threads
122, as shown in FIGS. 4A, 4D and 4F, generally have a larger pitch
at the distal end of the body 110 and a smaller pitch at the
proximal end of the body 110. The larger pitch distal threads 122
pull the annular tissue 52 a greater distance per revolution than
the smaller pitch proximal threads 122. Thus, as the reinforcement
member 100 is rotated and advanced into the annulus 52, the distal
threads pull the annular tissue together and the proximal threads
hold the tissue in place thereby compressing the annulus 52. By
compressing the annulus 52, the disc 50 is mechanically stabilized
and the fissures 56/58 are closed to facilitated healing.
[0076] Although compression of the annulus 52 is preferred, it is
not necessary to have compression in order to provide some degree
of mechanical stabilization. To the extent that compression is
desired, the variable pitch threads 122 mentioned above are
currently preferred. However, other compression techniques are
equally useful. For example, standard constant pitch threads 122
and tapered rings 124 may achieve compression by utilizing a
step-wise advancement and tension technique as will be described in
more detail hereinafter.
[0077] In order to provide the ability to temporarily heat the
reinforcement member 100 as discussed previously, various
modifications to the design of the reinforcement member 100 may be
made as described with reference to FIGS. 4H-4M. These design
modifications may also be applied to reinforcement members 200 and
300, but are described with specific reference to reinforcement
member 100 for purposes of illustration only. Although numerous
methods may be employed to temporarily heat the reinforcement
member 100, two preferred methods, resistive heating and inductive
heating are described in detail.
[0078] FIG. 4H illustrates a generic reinforcement member 100
including body portion 110, anchors 120 (not shown for sake of
clarity) and heating clement 140 in the form of a resistive wire.
FIG. 4I is a cross-sectional view taken along line 41-41 in FIG.
4H. Resistive wire 140 may be helically wound on the outer surface
of the body 110, the inner surface of the body 110, or in the wall
of the body 110. Preferably resistance wire 140 is helically
incorporated into the wall of the body portion 110 at the time of
fabrication, for example by insert/injection molding. Resistance
wire 140 may helically traverse the length of the body 110 in one
pitch direction, then traverses back in the opposite direction in
an opposite pitch direction. In this manner, a single wire
traverses the length of the body 110, but has two ends at the
proximal end of the body 110 available for connection to an
electrical power source or receiving antenna.
[0079] Resistance wire 140 is conductive, but offers a high enough
resistance to heat during the application of electrical current.
The wire may be made of a variety of conductive metals, including
copper, tungsten, platinum, or gold, and may be covered/coated with
a biocompatible material. Preferably, the resistance wire 140 is
formed of a biocompatible metal, but this is not essential as long
as direct tissue exposure is avoided such as when a biocompatible
covering/coating is used or when the wire 140 is embedded in the
wall of body 110. Since the wire will be heated to a relatively
high temperature (e.g., 50 to 90 degrees centigrade), the body 110
or covering is preferably made of a material which can withstand
elevated temperatures, preferably of a high temperature polymer
such as Polyimide, PTFE, Kynar, or PEEK.
[0080] Electrification of resistance wire 140 may be accomplished
by initially incorporating a pair of releasable low resistance lead
wires 142 to the ends of the resistance wire 140, as shown in FIG.
4H. The lead wires 142 are passed through or reside alongside
driver 440 during the advancement of reinforcement member 100 as
described with reference FIGS. 8A-8L. If they are passed through
the driver 440, the driver must be hollow. Once the reinforcement
member 100 is fully implanted, the lead wires 142 are connected to
a power source 146, which delivers electrical current to the
reinforcement member 100, causing it and the surrounding tissue to
heat to a desired temperature for a desired period of time. The
temperature of the resistance wire 140 may be monitored by
measuring the current demand from the power source 146 or by
positioning a thermocouple (not shown) adjacent the proximal end of
the reinforcement member 100. Once the heating step is finished,
the releasable leads 142 are removed from the resistance wires 140
utilizing releasable connection 141. Removal of the releasable
leads 142 may be accommodated by providing a low tensile strength
connection which separates by pulling, or by providing a fusible
metal strip connection which separates by applying electric current
above a threshold value. Such a fusible metal strip connection may
also serve to self-limit the degree to which the reinforcement
member is heated.
[0081] Alternatively, the leads 142 are not removable, but stay
attached to the resistive wires 140 and reinforcement member 100,
as illustrated in FIG. 4J. In this embodiment, and preferably after
the reinforcement member 100 is implanted, the leads 142 are
attached to an implantable receiver antenna such as conductive wire
coil 144. The receiver coil 144 may be incorporated into a housing
145 having a flat disc shape which is subcutaneously positioned
adjacent the access site. Since the lead wires 142 and the receiver
coil 144 are implanted within the body, the housing 145 and the
lead wires 142 are preferably encased in a biocompatible and stable
material, for example silicone rubber.
[0082] FIG. 4K illustrates an example of a suitable implant
position for the receiver coil 144, relative to the vertebral
column 10, preferably adjacent the lumbar disc being treated. The
receiver coil 144 and housing 145 are oriented parallel to the
surface of the skin, and the access site is then closed. Once
positioned, a similarly shaped transmitting coil 148 is placed on
the skin surface, adjacent and overlapping the subcutaneous
receiver coil 144. The transmitting coil 148 is connected to a
power source 146 and associated transmission circuit. When an
alternating current is delivered to the transmitting coil 148, a
corresponding alternating current is generated in the receiving
coil 144, which in turn causes the resistance wire 140 and the
reinforcement member 100 to heat.
[0083] One advantage of this resistive heating method is that the
heating procedure can be repeated multiple times, without the need
for reoperation or any other invasive procedure. For example, the
patient may have the implanted reinforcement member(s) 100 heated
upon initial implantation, and have them re-heated at any such time
as back pain may recur. One of the mechanisms by which heat is
believed to minimize back pain is by the destruction of nerve
endings at the periphery of the annulus. However, new nerve endings
may permeate the annulus, necessitating a subsequent heating to
return the patient to a pain-free state.
[0084] As an alternative to the antennas 144/148, a transdermal
plug 149 may be used to establish direct connection between the
leads 142 and the power source 146. The plug 129 includes an
internal implantable portion and an external portion. To facilitate
immediate heating of the reinforcement member 100, the internal and
external portions of the plug 129 may be connected just after
implantation of the reinforcement member 100, but prior to closing
the access site. The internal portion of the plug 129 is then
positioned just below the skin and the access site is closed. To
facilitate post-operative heating, a small incision may be made in
the skin to connect the internal and external portions of the plug
129.
[0085] An alternate method of heating reinforcement member 100 and
surrounding annular tissue is the use of inductive heating.
Inductive heating is used in many industrial and some medical
applications. Essentially, a high frequency alternating magnetic
field is oriented on the object to be heated. The alternating
magnetic field causes eddy currents in the object to be heated.
These eddy currents then cause ohmic heating. As long as the object
to be heated is conductive, usually metallic, it may be inductively
heated.
[0086] To facilitate inductive heating, all or a significant
portion of reinforcement member 100 is fabricated of a conductive
metal, such as stainless steel, carbon steel, MP35N, nickel
titanium alloy, or tungsten. The choice of material will influence
the parameters needed for the inducting power source. Preferably,
the entire body 110 is fabricated of the conductive metal.
[0087] With reference to FIG. 4M, the inductor may include a power
source 152 coupled by leads 154 to a coil 150 which generates a
large alternating magnetic field. The coil 150 may have a long
tubular shape, inside which the patient resides during heating, or
may be of a smaller size (as illustrated) which is oriented toward
the reinforcement member 100. The main parameters which need to be
adjusted to result in a desired heating of the reinforcement member
100 are the frequency and amplitude of the alternating magnetic
field. Typical frequencies will range from about 10 kHz to 10 MHz.
Inductive heating also has the advantage of allowing for multiple
subsequent heating treatments for the patient, should back pain
recur.
[0088] While the reinforcement member 100 is preferably a
permanently implanted device, the incorporation of temporary
heating immediately or shortly after implantation allows for the
possibility of temporary implantation. In this usage of
reinforcement member 100, it is implanted using the methods and
tools described in further detail below. But, once fully implanted,
a transient heating step is performed. Because the reinforcement
member causes the annular tissue to compress circumferentially
and/or radially, the heating is particularly effective at
remodeling the annular tissue to a more normal, pre-degenerated
condition. Therefore, it may not be necessary to keep the
reinforcement member implanted. The reinforcement member 100 can be
removed by essentially reversing the implantation steps. In order
to facilitate removal following heating, it is desirable to provide
a lubricious coating such as a hydropholic polymer or PTFE coating
on the surface of the reinforcement member 100, including the body
110 and anchor 120.
[0089] FIGS. 5A-5C schematically illustrate a circumferential
reinforcement member 200, which is generally the same as
reinforcement member 100 except as described herein. FIG. 5B is a
cross-sectional view taken along line 5B-5B in FIG. 5A, and FIG. 5C
is an end view taken along line 5C-5C in FIG. 5A. The
circumferential reinforcement member 200 includes a tubular body
210 defining a lumen 212 to facilitate advancement over a stylet.
The circumferential reinforcement member 200 also includes an
anchor 220, preferably in the form of variable pitch threads 222.
The proximal end of the body 210 the may include slots 216 or other
suitable mating geometry to facilitate rotation by a driver having
a mating distal end. Any of the variants of reinforcement member
100 discussed with reference to FIGS. 4A-4G may be applied to
circumferential reinforcement member 200.
[0090] The circumferential reinforcement member 200 may have a
geometry (e.g., circle, ellipse, oval, etc.) corresponding to the
geometry of the outer aspects of a healthy annulus 52, or the
member 200 may be naturally straight, taking on a curved shape
during implantation. Because the circumferential reinforcement
member 200 is implanted in the annulus 52 around the entire
periphery thereof, the reinforcement member maximizes anchoring
strength and provides superior stabilization around the entire disc
50. Thus, it is preferable that the reinforcement member 200 define
a closed geometry once implanted, or even have overlapping ends,
but an open geometry (e.g., semi-ellipse or semi-circle) may also
be employed. The size and shape of the reinforcement member 200 may
be pre-selected to accommodate anatomical variations of the annulus
52 between patients. The reinforcement member may have a relaxed
size that is smaller than the implanted size such that additional
radial and circumferential compression is achieved.
[0091] Circumferential reinforcement member 200 may further
incorporate design features which allow for temporary heating. As
described in connection with reinforcement 100 above, similar
features which allow for resistive heating or inductive heating may
be incorporated.
[0092] FIGS. 6A-6H schematically illustrate reinforcement member
300, including a pair of tubular pins 310, two screws 320 and two
connecting rings 330 which may be assembled as shown in FIG. 6F.
With reference to FIG. 6A, each of the tubular pins 310 includes a
shaft portion 312, a head portion 314 and a connection mechanism
318. The shaft 312 is sized to fit within a hole of the connection
ring 330 and the head 314 is sized larger than the same hole. The
connection mechanism 318 may comprises a threaded shaft insertable
into a threaded hole as shown, or any other known mechanical
releasable connection that maintains the profile of the shaft
portion 312. As seen in FIG. 6B, which is a cross-sectional view
taken along line 6B-6B in FIG. 6A, the shaft portion 312 includes a
lumen 313 to facilitate advancement over a stylet. The heads 314
may each include a slot 316 as seen in FIG. 6C, which is an end
view taken along line 6C-6C in FIG. 6A, or other suitable geometry
to mate with a distal end of a driver to facilitate rotation of the
pins 310 to screw the releasable connection together.
[0093] The screws 320 include a shaft 322, a head 324, threads 328
and a sharpened tip 323 as seen in FIG. 6D. The screws 320 may
comprise a wide variety of orthopedic screw designs, particularly
those suitable for implantation into cartilage and other
collagen-based tissues. The shaft 322 and threads 326 are sized to
fit within a hole of the connection ring 330 and the head 324 is
sized larger than the same hole. The head 324 includes slots 326 as
seen in FIG. 6E, which is an end view taken along line 6E-6E in
FIG. 6D, or other suitable mating geometry to facilitate rotation
by a driver having a mating distal end.
[0094] The connection rings 330 each have first and second rings
331/333 defining first and second holes 332/334 as shown in FIG.
6F. The first hole 332 is sized to provide a sliding fit about the
shaft 312 of the pins 310 and the second hole is sized to provide a
sliding fit about the shaft 322 and threads 326 of the screws 320.
As seen in the side view shown in FIG. 6G, each of the connection
rings 330 also define an angle 336 between the rings 331/333 to
accommodate the implanted arrangement as shown in FIG. 6H.
[0095] As described above in connection with reinforcement members
100 and 200, reinforcement member 300 can also incorporated
features to provide for temporary heating. For example, tubular
pins 310 can incorporate resistive wire, or can be fabricated of a
conductive metallic material, in a manner similar to that described
for reinforcement members 100 or 200 above.
[0096] Referring now to FIGS. 7A-7F, various tools 410, 420, 430
and 440 are shown individually and assembled. The tools 410, 420,
430 and 440 may be used to implant the reinforcement members 100
discussed above. The tools include a rigid, sharpened, hollow
trocar 410 as shown in FIG. 7A, a semi-rigid, sharpened, hollow
curved needle 420 as shown in FIG. 7B, a sharpened curved stylet
430 as shown in FIG. 7C, and a hollow driver 440 as shown in FIG.
7D. As seen in FIG. 7E, the sharpened stylet 430 fits into the
semi-rigid needle 420 which fits into the rigid trocar 410. As seen
in FIG. 7F, the sharpened stylet 430 fits into the hollow driver
440 which fits into the rigid trocar 410.
[0097] With specific reference to FIG. 7A, the rigid hollow trocar
410 includes a hollow shaft 412 and a grip or handle 414. The shaft
412 includes a sharpened tip 413 to facilitate passage through the
skin and back muscles, and insertion into the annulus 52. The shaft
412 is preferably made of a rigid metal such as a stainless steel
hypodermic tube. The grip 414 may comprise a polymer and may be
formed by insert injection molding with the shaft 412 inserted into
the mold.
[0098] With specific reference to FIG. 7B, the semi-rigid curved
needle 420 includes a hollow shaft 422 a hub 424. The shaft 422,
which includes a sharpened tip 423, is longer than the rigid trocar
410 and has an outside diameter sufficiently small to fit into the
rigid trocar 410. The shaft 422 is preferably made of a semi-rigid
polymer or composite. The shaft 422 includes a curved distal
portion 426 that may be straightened (shown in phantom) upon
insertion of the semi-rigid needle 420 into the lumen of the rigid
trocar 410. The hub 424 may include a fitting 425 to facilitate
connection to a fluid source or a pressure source (e.g., a
syringe).
[0099] With specific reference to FIG. 7C, the sharpened curved
stylet 430 includes a flexible shaft 432 and a sharpened distal end
433. The distal tip 433 may optionally include an anchor 435 such
as threads, tapered rings or barbs to facilitate the step-wise
advancement and tension technique as will be described in detail
hereinafter. If threads are used for the anchor 435, the curvature
434 of the distal portion of the shaft 432 may be eliminated to
facilitate efficient torque transfer. The shaft 432 includes a
curve 434 which approximates the curvature and diameter of the
outer aspects of the annulus where the reinforcement member 100 is
to be implanted. The shaft 432 is longer than the both the rigid
trocar 410 and the semi-rigid needle 420, and may have a length on
the order of 10 to 60 cm. The shaft 432 also has an outside
diameter sufficiently small to fit into the semi-rigid needle 420.
The shaft 422 preferably has a flexible but pushable construction
incorporating a rigid metal such as stainless steel, or
super-elastic nickel-titanium alloy. The sharpened stylet 430 is
preferably highly elastic, to resist permanent set upon insertion
into the curved portion 426 of the semi-rigid needle 420.
[0100] With specific reference to FIG. 7D, the hollow driver 440
includes a hollow shaft 442 and a grip or handle 444. The distal
end of the hollow shaft 442 includes a tip 446 defining a geometry
which mates with an end of the reinforcement member 100 to
facilitate rotation thereof during implantation. The shaft 442 is
preferably made of a torsionally rigid metal such as a stainless
tool steel. The grip 444 may comprise a polymer and may be formed
by insert injection molding with the shaft 442 inserted into the
mold.
[0101] With general reference to FIGS. 8A-8L, the steps for
implanting reinforcement member 100 are illustrated. It should be
understood that the procedure for implanting a single member 100 in
the posterior portion of the annulus 52 is shown for purposes of
illustration, not limitation. All of the variables with regard to
quantity, location, orientation, etc. discussed previously may be
implemented by varying the generic procedure described
hereinafter.
[0102] The method illustrated in FIGS. 8A-8L is a percutaneous
procedure in which access to the disc 50 is achieved utilizing a
number of small diameter tools which may be inserted through a
patient's back (skin and back muscles), between adjacent vertebrae,
and into the patient's disc 50. This percutaneous method minimizes
the invasiveness of the procedure thereby reducing procedure time,
procedure cost, postoperative pain and recovery time.
[0103] Initially, as shown in FIG. 8A, the rigid trocar 410 is
positioned for insertion into the disc 50 as in a conventional
discogram procedure. The rigid trocar 410 is advanced until the
distal tip 413 of the trocar 410 is proximate the outer periphery
of the posterior portion of the annulus 52 as seen in FIG. 8B.
[0104] The curved portion 426 of the semi-rigid needle 420 is
straightened for insertion into the trocar 410 as shown in FIG. 8C.
The semi-rigid needle 420 (alone or with stylet 430) is advanced
relative to the rigid trocar 410 until the curved portion 426 of
the semi-rigid needle exits the distal tip 413 of the rigid trocar
410 and the desired amount of curvature is established, as seen in
FIG. 8D. The curved portion 426 may be advanced until the tip 423
is roughly parallel to the posterior curvature of the annulus
52.
[0105] The sharpened stylet 430 is then positioned for insertion
into the semi-rigid needle 420 as shown in FIG. 8E. The sharpened
stylet 430 is advanced relative to the semi-rigid needle 420 until
the distal tip 433 of the stylet 430 extends across radial fissures
56, as shown in FIG. 8F.
[0106] The semi-rigid curved needle 420 is removed from the stylet
430 and trocar 410, and the reinforcement member 100 is positioned
for advancement over the stylet 430 as shown in FIG. 8G. The
reinforcement member 100 is advanced over the stylet 430 and into
the trocar 410, and the driver 440 is positioned for advancement
over the stylet 430 as shown in FIG. 8H. The driver 440 is then
rotated and advanced over the stylet 430 in order to rotate and
push the reinforcement member 100 into the annulus and across the
radial fissures 56 as seen in FIG. 81. If the reinforcement member
100 utilizes an anchor other than threads, the driver 440 may be
used to simply push or otherwise advance the reinforcement member
100 through the trocar 410 and into the annulus 52.
[0107] If a solid cross-section reinforcement member 100 is
utilized, it is not necessary to utilize the stylet 430. In this
situation, the curved semi-rigid needle 420 is left in place as
shown in FIG. 8E and the solid cross-section reinforcement member
100 is advanced therethrough. The driver 440 is then rotated and
advanced through the curved semi-rigid needle 420 in order to
rotate and push the reinforcement member 100 into the annulus 52
and across the radial fissures 56. In this alternative method, it
may be necessary to resize the curved semi-rigid needle 420 to
accommodate the driver 440 and reinforcement member 100.
[0108] The variable pitch threads on the reinforcement member 100
compress the disc 50 and cause the fissures 56 to close as
discussed previously. If variable pitch threads are not utilized on
the reinforcement member 100, other techniques may be used to
compress the disc 50 and close the radial fissures 56. An example
of an alternative disc 50 compression technique is a step-wise
advancement and tension method. In this alternative method, the
distal tip 433 of the stylet 430 is incorporated with an anchor 435
such as threads. After the distal tip 433 of the stylet 430 has
been advanced by rotation to extend across the fissures 56, and
before the reinforcement member 100 has been advanced into the
annulus 52, the stylet is pulled in the proximal direction to apply
tension thereto. Because the threaded anchor at the distal end 433
of the stylet 430 grips the annulus 52, tension applied to the
stylet 430 compresses a portion of the disc 50 and closes the
fissures 56. Once compression of the disc 50 and closure of the
fissures 56 are established, the reinforcement member 100 may be
advanced into the annulus 52 to maintain disc 50 compression and
hold the fissures 56 closed. This method of step-wise advancement
and tension may be repeated until the reinforcement member 100 is
fully implanted in the desired position within the annulus 52.
[0109] After the reinforcement member 100 is positioned across the
radial fissures 56 as shown in FIG. 81, the stylet is advanced
until the distal tip extends across the circumferential fissure 58
as shown in FIG. 8J. Note that the curvature 434 of the stylet 430
defines the insertion path of the reinforcement member 100. It has
been observed that the preset curvature 434 of the stylet 430 will
correspond to the insertion path if the tip 433 is very sharp. With
the stylet 430 advanced such that the tip extends across fissure
58, the driver 440 is then used to rotate and advance the
reinforcement member 100 across the fissure 58 as shown in FIG. 8K.
The variable pitch threads on the reinforcement member 100 compress
the disc 50 and cause the fissure 58 to close as discussed
previously. Once the reinforcement member 100 is completely
deployed within the annulus 52 as shown in FIG. 8L, the tools
410/430/440 may be removed from the patient and the procedure is
essentially complete.
[0110] With general reference to FIGS. 9A-9F, schematic
illustrations of additional tools 450/460/720 for use in the method
of implanting reinforcement member 200 are shown. The additional
tools include a variable curvature stylet 450 as shown in FIG. 9A,
a stiffening mandrel 460 as shown in FIG. 9B, and an advancement
tool 720 as shown in FIG. 9D. The variable curvature stylet 450 is
hollow which permits insertion of the stiffening mandrel 460 as
shown in FIG. 9C.
[0111] As seen in FIG. 9A, the variable curvature stylet 450
includes a tubular shaft 452, a curved distal portion 454 and a
closed distal end 453 which is sharpened. The variable curvature
stylet 450 is substantially the same as the curved stylet 430
described previously, except for the provision of a lumen into
which the stiffening mandrel 460 is insertable. As seen in FIG. 9B,
the stiffening mandrel 460 includes an elongate shaft 462 and a
blunt tip 463. The shaft 462 and tip 463 of the stiffening mandrel
460 are sized to be inserted into the hollow shaft 452 of the
stylet 450. The hollow stylet 450 and the stiffening mandrel 460
may be made of stainless steel, nickel titanium alloy or the
like.
[0112] As can be seen from a comparison of FIGS. 9A and 9C, upon
insertion of the stiffening mandrel 460 into the hollow stylet 450,
the curvature increases. Preferably the stiffening mandrel 460 is
inserted fully into the hollow stylet 450 to increase the radius of
curvature of the distal portion of the curvature 454, since the
distal portion of the curvature 454 dictates the path that the
stylet 450 will follow. The relative stiffness of the stylet 450
and stiffening mandrel 460 may be selected to vary the amount of
change in the curvature 454. The variable curvature 454 may be used
to navigate around the changing curvature of the annulus 52 as
described hereinafter. At any point during advancement of the
stylet 450, the curvature 454 may be adjusted by insertion of an
appropriately stiff mandrel 460. The path defined by the stylet 450
may thus be customized to any particular disc 50 anatomy.
[0113] As seen in FIG. 9D, advancement tool 720 may be optionally
employed to drive the distal end of the hollow stylet 450 through
annular tissue 52. The advancement tool 720 includes an elongate
tubular shaft 722, with a handle 724 connected to its proximal end
and a plurality of threads 726 connected to its distal end. The
tubular shaft 722 of the advancement tool 720 includes a lumen
which is sized to accommodate the variable curvature stylet 450
therein. To transfer forces from the distal end of the advancement
tool 720 to the distal end of the stylet 450, the variable
curvature stylet 450 may include a tapered collar 456. With this
arrangement, the advancement tool 720 may be advanced over the
variable curvature stylet 450 until the distal end of the shaft 722
abuts the collar 456 on the variable curvature stylet 450. During
use, the threads 726 engage the annular tissue 52 and upon
rotation, apply longitudinal forces against the collar 456, and
thereby cause distal advancement of the variable curvature stylet
450. The threads 726 are rotated by manually rotating handle 724,
which transmits torsional forces along the elongate shaft 722 to
the distal threads 726. To provide adequate transmission of
torsional forces, the tubular shaft 722 may further comprise a
composite structure as illustrated in FIG. 9E or metallic tubular
structure as illustrated in FIG. 9F.
[0114] With specific reference to FIG. 9E, the tubular shaft 722
comprises a composite structure having an outer layer 721 disposed
about a reinforcement layer 723 disposed about an inner layer 725.
The outer layer 721 and the inner layer 725 may comprise a
polymeric material having a relatively low coefficient of friction
such as PTFE or HDPE. The reinforcement layer 723 is preferably
torsionally rigid in both directions of rotation, as may be
provided by an interwoven wire braid or by multiple wire coils
wound in opposite directions.
[0115] With specific reference to FIG. 9F, the elongate tubular
shaft 722 comprises a tube 727 which may be formed of a highly
elastic and rigid metal such as stainless steel, nickel titanium
alloy, or the like. The metallic tube 727 includes a plurality of
slots 729 spaced at regular increments along the length of the
shaft 722. The slots 729 extend through the wall of the metallic
tube 727, but do not extend about the entire circumference of the
metallic tube 727. Thus, the slots 729 impart flexibility to the
flexible tube 727, while maintaining torsional rigidity
thereof.
[0116] With general reference to FIGS. 10A-10H, the steps for
implanting circumferential reinforcement member 200 are
illustrated. All of the variables with regard to quantity,
location, orientation, etc. discussed previously may be implemented
by varying the generic procedure described hereinafter. The method
illustrated in FIGS. 10A-10H is a percutaneous procedure in which
access to the disc 50 is achieved utilizing a number of small
diameter tools which may be inserted through a patient's back (skin
and back muscles), between adjacent vertebrae, and into the
patient's disc 50.
[0117] Initially, as shown in FIG. 10A, the rigid trocar 410 is
advanced into the annulus 52 of the disc 50. The trocar 410 is
advanced until the distal tip 413 thereof is disposed in the
lateral portion of the annulus 52 roughly half way between the
posterior and anterior portions of the annulus 52 as seen in FIG.
10B. The hollow curved stylet 450 with the stiffening mandrel 460
inserted therein is then advanced into the trocar 410. Note that an
appropriate stiff mandrel 460 has been fully inserted into the
hollow stylet 450 a sufficient distance to define a curvature 454
that approximates the curvature of the anterior portion of the
annulus 52. Continued advancement of the hollow stylet 450 and
stiffening mandrel 460 as a unit cause the stylet 450 to traverse
the anterior portion of the annulus 52 as shown in FIG. 10C.
[0118] After the distal tip 453 of the stylet 450 is positioned
roughly half way between the posterior and anterior portions of the
annulus 52 as seen in FIG. 10C, the stiffening mandrel 460 is
retracted or removed from the stylet 450 to define a smaller
curvature 454 that approximates the curvature of the posterior
lateral portion of the annulus 52. The stylet 450 is then advanced
until the distal tip 453 thereof enters the posterior portion of
the annulus 52 as shown in FIG. 10D.
[0119] An appropriately stiff mandrel 460 is then advanced or
inserted into the hollow stylet 450 to define a curvature 454 that
approximates the curvature of the posterior portion of the annulus
52. The stylet is then advanced across the posterior portion of the
annulus 52. The stiffening mandrel 460 is then retracted or removed
from the stylet 450 to define a smaller curvature 454 that
approximates the curvature of the posterior lateral portion of the
annulus 52. The stylet 450 is then advanced until the distal tip
453 thereof is positioned adjacent the distal tip 413 of the trocar
410 as shown in FIG. 10E.
[0120] The trocar 410 is then removed from the patient leaving the
stylet 450 in the annulus 52 to define the insertion path for the
reinforcement member 200 as shown in FIG. 10F. The circumferential
reinforcement member 200 and driver 440 are then advanced over the
stylet 450 as shown in FIG. 10G. Using the driver 440 to push and
rotate the circumferential reinforcement member 200, the member 200
is advanced into the annulus 52 along the path defined by the
stylet 450 until the distal end of the reinforcement member 200 is
adjacent the proximal end of the reinforcement member 200. Note
that the variable pitch threads 222 compress the disc 50 and cause
the fissure 56/58 to close. If the reinforcement member 200
includes an anchor 220 other than threads (e.g., sloped rings,
barbs, etc.) the driver 440 may be used to simply push the
reinforcement member 200 into the annulus 52. Once the
reinforcement member 200 is in the desired position, the driver 440
and stylet 450 may be removed from the patient to complete the
procedure.
[0121] With general reference to FIGS. 11A-11H, the steps for
implanting reinforcement member 300 are illustrated. All of the
variables with regard to quantity, location, orientation, etc.
discussed previously may be implemented by varying the generic
procedure described hereinafter. The method illustrated in FIGS.
11A-11H is a percutaneous procedure in which access to the disc 50
is achieved utilizing a number of small diameter tools which may be
inserted through a patient's back (skin and back muscles), between
adjacent vertebrae, and into the patient's disc 50.
[0122] Initially, as shown in FIG. 11A, two trocars 410 are
positioned for insertion into the disc 50. The trocars 410 are
advanced until the distal tip 413 of each trocar 410 is proximate
the outer periphery of the posterior portion of the annulus 52 as
seen in FIG. 11B. The curved stylet 430 is then advanced into one
of the trocars 410 and advanced into the annulus 52 as shown in
FIG. 11C. The curved stylet 430 is then advanced across the
posterior annulus 52, into the distal tip 413 of the other trocar
410, and out the proximal end of the other trocar 410 as shown in
FIG. 11D. The curvature 434 of the stylet 430 is selected such that
the tip 433 of the stylet 430 traverses the posterior portion of
the annulus 52 and automatically enters into the other trocar 410.
To facilitate automatic insertion of the stylet into the other
trocar 410, the inside diameter of the trocar 410 may be tapered to
increase the inside diameter closer to the tip 413. As mentioned
previously, the stylet 430 will follow a path in the annulus 52
corresponding to the curvature 434 of the stylet 430 if the tip 433
is very sharp.
[0123] The trocars 410 are then removed from the patient leaving
the stylet 430 in place as shown in FIG. 11E. Also as shown in FIG.
11E, the screws 320 are placed in the holes 334 of the connection
rings 330, and the connection rings 330 are slid onto the stylet
430 through holes 332. The screws 320 are then screwed into the
annulus 52 as shown in FIG. 11F using a conventional driver (not
shown). Placing the screws 320 in the lateral portions of the
annulus 52 takes advantage of the generally greater integrity
(usually thicker and healthier) of the lateral portions of the
annulus 52 to establish firm anchor points.
[0124] Also as shown in FIG. 11F, the tubular pins 310 are
positioned on the stylet 430. The tubular pins 310 are then
advanced over the stylet 430, across the posterior portion of the
annulus 52, and screwed together as shown in FIG. 11 G using driver
440 (not shown). The pins 310 are have an assembled length which is
shorter than the length of the stylet traversing the annulus 52
such that connection of the pins 310 causes compression of the disc
50 and closure of the fissures 56/58. After removal of the stylet
430, the screws 320 may be tightened further into the annulus 52 in
order to further compress the disc 50 and close the fissures 56/58
as shown in FIG. 11 H.
[0125] With general reference to FIGS. 12A-12G, FIGS. 13-15, FIGS.
16A-16E, and FIGS. 17A-17D, schematic illustrations of additional
tools 710/730/740/750/800/900 are shown for use in implanting
reinforcement member 600 in accordance with the method illustrated
in FIGS. 18A-18L. The additional tools include a curved stylet or
needle 710 as shown FIGS. 12A-12G, a guide tube or sheath 730 as
shown in FIG. 13, a pledget push rod 740 as shown in FIG. 14, a
pledget 750 as shown in FIGS. 14 and 15, a column support and
advancement device 800 for stylet 710 as shown in FIGS. 16A-16E,
and a column support and advancement device 900 for stylet 710 and
sheath 730 as shown in FIGS. 17A-17D. Tools 710/730/800/900 and the
associated method may be utilized to implant other reinforcement
members described herein, including reinforcement members
100/200/300.
[0126] With specific reference to FIGS. 12A-12G, the stylet or
needle 710 includes a flexible elongate shaft 711 and a sharpened
distal end 714. The stylet 710 is similar to the curved stylet 430
described with reference to FIG. 7C, except as described herein and
apparent from the drawings. The stylet or needle 710 may have a
substantially straight distal portion 712A as shown in FIG. 12A.
Alternatively, the stylet 710 may be curved as illustrated in FIGS.
12B-12E.
[0127] For example, in FIG. 12A, the stylet 710A includes a
straight distal portion 712A. In FIG. 12B, the stylet 710B includes
a curved portion 712B having a curvature that may, for example,
correspond to the anterior curvature of the annulus 52. In FIG.
12C, the stylet 710C includes a curved portion 712C having a
curvature that may, for example, correspond to the curvature of the
lateral portions of the annulus 52. In FIG. 12D, the stylet 710D
includes a distal curved portion 712D having a curvature that
permits relatively sharp turns or counter-turns during navigation
through the annulus 52. In FIG. 12E, the stylet 710E has a primary
curvature 712E and a secondary opposite curvature 716E proximal
thereon. The provision of a primary curvature 712E in addition to a
secondary opposite curvature 716E allows the stylet 710E to change
directions during navigation within the annulus 52. To this end,
the secondary curvature 716E may have a curvature corresponding to
the path already defined through the annulus 52 during navigation,
and the primary curvature 712E may have a curvature corresponding
to the path to be taken by the stylet 710E upon further advancement
through the annulus 52. Although a limited number of distal
configurations 712 have been illustrated, it is contemplated that a
variety of stylets 710 having a variety of distal geometries 712
may be employed during the implantation procedures described
hereinafter.
[0128] The shaft 711 of the stylet 710 preferably has a flexible
but pushable construction incorporating a rigid metal mandrel such
as stainless steel, or a super-elastic alloy such as
nickel-titanium. Highly elastic or super-elastic materials
incorporated into the elongate shaft 711 resist permanent
deformation during insertion and navigation through the annulus 52.
The shaft 711 of the stylet 710 may have a diameter ranging from
0.010 to 0.025 inches, which may vary depending on the tortuosity
of the annular path and the characteristics (toughness, friction)
of the annular material 52. The shaft 711 may be coated with a
lubricious material such as PTFE and a hydrophilic polymer.
[0129] It has been found that if the tip 714 is sufficiently sharp
to easily penetrate annular tissue 52, the path through the annular
tissue 52 taken by the stylet 710 will substantially conform to the
geometry of the distal portion 712 of the stylet 710. In
particular, if the distal portion 712 is substantially straight,
the stylet 710 will define a linear path through the annular tissue
52. Alternatively, if the distal portion 712 has a curve or other
nonlinear geometry (in a relaxed state), the stylet 710 will define
a path through the annular tissue 52 corresponding to the shape of
the distal portion 712. To this end, it is desirable to provide a
tip 714 having sufficient sharpness to readily penetrate annular
tissue 52, which tends to be relatively fibrous and tough. The
distal tip 714 may have a symmetrical geometry 714A as illustrated
in FIG. 12F or an asymmetrical geometry 714B as illustrated in FIG.
12G, and preferably has a fine to micro-fine sharpness. By
providing a sufficiently sharp tip 714, navigation through the
annulus 52 may be performed in a predictable manner as described in
more detail hereinafter.
[0130] With specific reference to FIG. 13, the guide tube or sheath
730 includes an elongate tubular shaft 732 having a lumen extending
therethrough sized to accommodate the stylet 710. The guide tube or
sheath 730 preferably has a relatively thin wall structure so as to
minimize the increase in profile relative to the stylet 710. In
addition, the inside surface of the shaft 732 preferably has a low
friction coating or liner such as PTFE to minimize friction between
the guide sheath 730 and the stylet 710. The guide sheath 730
preferably is able to withstand relatively high longitudinal
compressive forces and therefore, preferably comprises a relatively
rigid but flexible material such as PTFE or polyimide. For example,
the tubular shaft 732 may comprise a polyimide tube having an
inside diameter approximately 0.0005 to 0.001 inches greater than
the outside diameter of the stylet 710, with a wall thickness of
approximately 0.0005 to 0.003 inches. The tubular shaft 732 may
further incorporate a reinforcement layer such as a metallic braid
or the like to help prevent various modes of buckling.
[0131] With specific reference to FIG. 14, the pledget push rod 740
includes an elongate rigid shaft 742 comprising, for example, a
stainless steel rod. The distal end of the shaft 742 is connected
to pledget 750 by way of a releasable connection 744. Releasable
connection 744 may comprise, for example, a weakened area of the
rod 742 or pledget 750 that may be broken by application of
torsional forces to the rod 742.
[0132] With specific reference to FIG. 15, the pledget 750 includes
a body portion 752 and two holes 754 sized to accommodate the
stylet 710 and reinforcement member 600. The body portion 752 may
comprise a metallic or polymeric material. Examples of suitable
metallic materials include stainless steel and super-elastic alloys
such as nickel-titanium. If the body portion 752 comprises a
polymeric material, the polymeric material may be biologically
inert, biodegradable or bioabsorbable. Examples of suitable
polymeric materials comprising biologically stable or inert
materials include HDPE and PTFE. Examples of biodegradable or
bioabsorbable materials include resorbable collagen, LPLA
(poly(l-lactide)), DLPLA (poly(dl-lactide)), LPLA-DLPLA, PGA
(polyglycolide), PGA-LPLA or PGA-DLPLA. The body portion 752 of the
pledget 750 may be coated with biocompatible materials, growth
factors to facilitate healing, agents which render the nuclear
matter inert or otherwise reduce chemical irritation thereof,
and/or anesthetic agents to reduce nerve signal transmission (i.e.,
pain).
[0133] With specific reference to FIGS. 16A-16E, the column support
and advancement device 800 for use with stylet 710 is shown. Device
810 includes a shaft portion 810 which extends through and is
rigidly connected to a proximal handle assembly 812. The distal end
of the shaft 810 may incorporate a plurality of threads 814 to
rotationally engage and bore through tissues in the back (dermal
and muscular tissues) and anchor against tissues immediately
adjacent the point of entry into the annulus 52. The distal tip 815
of the shaft 810 may also be sharpened to facilitate penetration
through tissues in the back. The shaft 810 comprises a rigid metal
tube having a lumen extending therethrough adapted to receive the
stylet 710. The inside surface of the tubular shaft 810 may be
provided with a low friction liner or coating such as PTFE. Within
the handle 812, the shaft 810 includes a slot aligned with a slot
or keyway 816 in the handle 812, which is sized and shaped to
accommodate key 820. The slot in the shaft 810 contained within the
handle assembly 812 has a width that is less than that of the
outside diameter of the stylet 710 such that the stylet 710 cannot
pass therethrough and such that the shaft 810 provides column
support to the stylet 710 and prohibits buckling thereof.
[0134] Key 820 includes a thumb button 822 which may incorporate a
plurality of grip members 828. A metallic plate 824 extends
downwardly from the body portion 822 and has a geometry which
substantially conforms to keyway 816. The bottom of the plate 824
incorporates one or more protrusions 826. Protrusions 826 engage
and mate with recesses 715 formed in the proximal end of the stylet
710. Protrusions 826 and recesses 715 may be replaced by a wide
variety of mating geometries to facilitate engagement between the
key 820 and the proximal end of the stylet 710.
[0135] Upon depression of the thumb button 822 relative to the
handle 812, the plate 824 travels in a downward direction to force
the protrusions 826 into the recesses 715. The thumb button 822 may
then be advanced in the distal direction, while maintaining
downward pressure, to advance the stylet 710 in the distal
direction relative to the shaft 810 into annular tissue 52.
Although the stylet 710 may encounter substantial resistance during
advancement through annular tissue 52, and despite the relative
flexibility of the stylet 710, the shaft 810 of the advancement
device 800 provides sufficient column strength to the stylet 710 to
resist buckling during advancement.
[0136] After the key 820 has been advanced to the distal end of the
handle 812, the downward force applied to the thumb button 822 may
be removed to disengage the protrusions 826 from the recesses 715
in the stylet 710. To facilitate disengagement of the teeth 826
from the recesses 715, a pair of leaf springs 825 may be provided
on either side of the plate 824 to urge the key 820 in the upward
direction relative to the handle 812. In the disengaged position,
the key 820 may be moved to the proximal end of the handle 812, and
a downward force may be reapplied to the thumb button 822 to cause
engagement of the protrusions 826 with the recesses 715. The thumb
button 822 may then be advanced again in the distal direction
relative to the handle 812 to advance the stylet 710 further into
the annular tissue 52.
[0137] This procedure may be repeated until the stylet 710 is
advanced the desired distance. In addition, with the key 820 in the
disengaged position, the stylet 710 may be removed for a different
stylet 710 having a different distal curvature, for example. To
exchange the stylet 710, downward pressure against the thumb button
822 is removed to allow the key 820 to be urged in the upward
direction by springs 825, to thereby disengage the protrusions 826
from the recesses 715. In the disengaged position, the stylet 710
may be removed from the device 800 by pulling the stylet 710 in the
proximal direction. A second stylet 710 may be inserted into the
device 800 by inserting the distal end of the stylet 710 into the
proximal end of the lumen of the shaft 810 located at the proximal
end of the handle assembly 812. The stylet may then be advanced
until the distal end thereof exits the distal end of the shaft
810.
[0138] With specific reference to FIGS. 17A-17D, column support and
advancement device 900 for use with stylet 710 and sheath 730 is
shown. Device 900 includes a rigid metallic tubular shaft 910
having a handle 912 connected to its proximal end. A plurality of
threads 914 are provided at the distal end of the shaft 910 to
facilitate advancement through tissues up to the perimeter of the
annulus 52, and to facilitate anchoring of the tubular shaft 910
adjacent the periphery of the annulus 52. The distal tip 915 of the
tubular shaft 910 is sharpened to facilitate advancement through
dermal and muscular tissues in the back up to and adjacent the
annulus 52. The tubular shaft 910 has an inside diameter sized to
accommodate the guide sheath 730 which is sized to accommodate the
stylet 710. The inside diameter of the tubular shaft 910 may
incorporate a low friction coating such as PTFE to minimize
friction between the tubular shaft 910 and the tubular sheath
730.
[0139] The tubular shaft 910 includes a helical slot 916 which
passes through the wall thereof and extends from a point adjacent
the handle 912 to a mid portion of the shaft 910. A proximal nut
920 and a distal nut 930 are disposed about the shaft 910 and
cooperate with the helical slot 916 such that they may be
independently longitudinally advanced and retracted by rotation
thereof relative to the shaft 910.
[0140] As best seen in FIG. 17B, the proximal nut 920 abuts a
collar 918 fixedly connected to the stylet 710. Similarly, the
distal nut 930 abuts a collar 732 fixedly attached to the tubular
sheath 730. Thus, longitudinal advancement of nut 920 by rotation
thereof relative to the shaft 910 causes corresponding longitudinal
advancement of the stylet 710. Similarly, longitudinal advancement
of nut 930 by rotation thereof relative to shaft 910 causes
corresponding longitudinal advancement of the tubular sheath
730.
[0141] As seen in FIG. 17C, proximal nut 920 includes a collar 924
connected to a bearing 926 by a pair of arms 922. The arms 922
extend through the helical slot 916 in the shaft 910. The collar
924 extends around the outside of the shaft 910, and the bearing
926 fits within the lumen of the shaft 910. The bearing 926 has an
inside diameter sized to accommodate the stylet 710 in an outside
diameter sufficient to engage and abut the collar 718, while
permitting relative rotational movement. The side openings 928 in
the collar 924 and bearing 926 permit the proximal nut 920 to be
removed from the shaft 910, which in turn permits the stylet 710 to
be removed from the device 900 and replaced with a different stylet
710 having a different distal curvature, for example.
[0142] As seen in FIG. 17D, the distal nut 730 includes a collar
934 connected to a bearing 936 by a pair of arms 932. The collar
934 has an inside diameter sufficient to accommodate the outside
diameter of the shaft 910. The bearing 936 has an outside diameter
sized to fit within the lumen of the shaft 910 and sized to engage
and abut the collar 732 on the tubular sheath 730. The bearing 936
also has an inside diameter sufficient to accommodate the tubular
sheath 730, while allowing relative rotational movement.
[0143] With this arrangement, the stylet 710 may be advanced
independently of the sheath 730, and visa-versa. In addition, with
this arrangement, both the tubular sheath 730 and the stylet 710
have column support proximal of the path being navigated through
the annulus 52.
[0144] With general reference to FIGS. 18A-18L, the steps for
implanting reinforcement member 600 are illustrated. The method
illustrated in FIGS. 18A-18L utilizes stylet 710 to navigate
through the annulus 52 and implant reinforcement member 600. The
method illustrated in FIGS. 18A-18L may be modified to make use of
hollow stylet 450 and stiffening mandrel 460 to navigate through
the annulus 52 and implant reinforcement member 600. All of the
variables with regard to quantity, location, orientation, etc.,
discussed previously may be implemented by varying the generic
procedure described hereinafter. The method illustrated in FIGS.
18A-18L is a percutaneous procedure in which access to the disc 50
is achieved utilizing a number of small diameter tools which may be
inserted through a patient's back (skin and back muscles), between
adjacent vertebrae, and adjacent the patient's disc 50.
[0145] Initially, as shown in FIG. 18A, the rigid trocar 410 is
advanced until the distal tip thereof is disposed immediately
adjacent the periphery of the annulus 52 of the disc 50. A stylet
710C, with tubular sheath 730 disposed thereon, is inserted into
the rigid trocar 410. The stylet 710C, having a curved distal
portion 712C, is advanced out the distal end of the trocar 410 into
the annulus 52 until the distal end of the stylet 710C is located
in the anterior portion of the annulus 52 as shown in FIG. 18B.
Note that the curvature of the distal portion 712C roughly
corresponds to the curvature of the lateral annulus 52. The sheath
730 may then be advanced over the stylet 710C until the distal end
of the sheath is adjacent the distal end of the stylet 710.
[0146] The stylet 710C may then be removed from the sheath 730, and
another stylet 710B, having a curved distal portion 712B, may be
advanced through the sheath 730 as shown in FIG. 18C. In this
manner, the tubular sheath 730 maintains the path defined by the
penetrating stylet 710C, and allows the next stylet 710B to begin
penetration where stylet 710C left off. The stylet 710B is advanced
until the distal tip is positioned in the lateral portion of the
annulus, after which the tubular sheath 730 may be advanced
thereover. Note that the curvature of the distal portion 712B
roughly corresponds to the curvatures of the anterior annulus 52.
The stylet 710B may be exchanged for stylet 710C having a curved
portion 712C to traverse the lateral side of the annulus 52. The
stylet 710C may then be exchanged for another stylet 710A having a
relatively straight distal portion 712A to traverse the posterior
portion of the annulus 52 as shown in FIG. 18D. The tubular sheath
730 is then advanced over the stylet 710A until the distal end of
the sheath 730 is adjacent the distal end of the stylet 710A.
[0147] Once the distal end of the stylet 710A and the distal end of
the tubular sheath 730 are disposed adjacent the opening to the
distal end of the trocar 410, the straight stylet 710A may be
exchanged for double curve stylet 710E as shown in FIG. 18E. The
distal tip of the stylet 710E is navigated into the distal end of
the trocar 410 utilizing the visualization techniques described
previously. Once the distal end of the stylet 710 is disposed in
the trocar 410, the tubular sheath 730 may be removed. With the
distal end of the stylet 710E reentered into the distal end of the
trocar 410, the stylet 710E may be freely advanced until the distal
portion thereof exits the proximal portion of the trocar 410 as
shown in FIG. 18F.
[0148] At this point, the trocar 410 may also be removed, but may
optionally be left in place, depending on the means employed to
connect the ends of the reinforcement member 600. As illustrated in
FIG. 18G, one end 602 of the reinforcement member 600 is connected
to the proximal end of the stylet 710. This may be accomplished,
for example, by threading the reinforcement member through a hole
(not shown) in the proximal end of the stylet 710 similar to the
threading a sewing needle. Immediately before or immediately after
the reinforcement member 600 is attached to the proximal end of the
stylet 710, the pledget push rod 740 may be used to push the
pledget 750 over the opposite ends of the stylet 710 until the
pledget 750 is positioned immediately adjacent the entry and exit
points in the annulus 52 as illustrated in FIG. 18G.
[0149] The distal end of the stylet 710 may then be pulled while
applying a push force to the push rod 740 to pull the reinforcement
member along the path defined the stylet 710 through the annulus
52, after which the reinforcement member 600 may be disconnected
from the stylet as shown in FIG. 18H. A connection (e.g., knot) 610
may be made in the reinforcement member 600 and advanced to the
pledget 750 utilizing a conventional knot pusher (not shown) as
shown in FIG. 181. While the knot is being tightened, the
reinforcement member 600 applies compressive forces about the
perimeter of the annulus 52 thereby closing fractures and fissures
56/58. Once the knot 610 has been tightened, the reinforcement
member 600 may be cut immediately proximal of the knot 610 adjacent
the pledget 750 as shown in FIG. 18J utilizing a conventional
suture cutting device (not shown).
[0150] Alternatively, as shown in FIGS. 18K and 18L, the pledget
750 may be omitted. In particular, a connection (e.g., knot) 610
may be made in the reinforcement member 600 and advanced to the
entry and exit point in the annulus 52 utilizing a conventional
knot pusher (not shown) as shown in FIG. 18K. While the knot is
being tightened, the reinforcement member 600 applies compressive
forces about the perimeter of the annulus 52 thereby closing
fractures and fissures 56/58. Once the knot 610 has been tightened,
the reinforcement member may be cut utilizing a conventional suture
cutting device (not shown) immediately proximal of the knot 610 as
shown in FIG. 18L.
[0151] The path navigated through the annulus 52 by the foregoing
method may be a function of the individual anatomical geometry of
the patient and/or the particular portion of the annulus 52
requiring compression. Accordingly, as shown in FIGS. 19A-19F, the
path 620 defined by the stylet 710 and reinforcement member 600
through the annulus 52 may vary. For example, a substantial
rectangular path 620A with rounded corners may be employed as
illustrated in FIG. 19A. Alternatively, a substantially trapezoidal
path 620B having rounded corners may be employed as shown in FIG.
19B. Alternatively, a substantially oval path 620C may be employed
as shown in FIG. 19C. Each of these paths may be defined by the
particular sequence of curved stylets 710 utilized in accordance
with the method described previously.
[0152] Although it is preferable to define a path 620 substantially
confined to the annulus 52, the path 620 may also extend through a
portion of the nucleus 54 as illustrated in FIGS. 19D and 19E. In
such circumstances, it is preferable to not define a direct path
from the nucleus 54 to the exterior of the annulus 52, to thereby
minimize the likelihood that nuclear material will leak out of the
disc 50. For example, as shown in FIG. 19D, the path through the
nucleus 54 may enter at one lateral side, and exit at the opposite
lateral side thereof. Alternatively, as shown in FIG. 19E, the path
620E may enter on the anterior side and exit on the posterior side
of the nucleus 54. FIG. 19F illustrates a path 620F which is just
external to the outer surface of the annulus 52.
[0153] While a single path 620 followed by a single reinforcement
member 600 is illustrated, it is also contemplated that multiple
reinforcement members 600 may be implanted. For example, one
reinforcement member 600 could be implanted proximate the lower
(inferior) portion of the annulus 52 and one reinforcement member
600 could be implanted in the upper (superior) portion of the
annulus 52. Any number of reinforcement members 600 could be
implanted in a single disc, either through a single trocar 410
placement, or multiple trocar placements.
[0154] With general reference to FIGS. 20A-20R, alternative
embodiments of reinforcement members and methods of implantation
are disclosed. The reinforcement members 510/520/530 may be used to
reinforce the disc, restore disc height and/or bear some or all of
the load normally carried by the annulus. The reinforcement members
510/520/530 are relatively rigid and thus serve to reinforce the
disc 50, and particularly the annulus 52, where inserted. In
addition, the reinforcement members 510/520/530 may have a
relatively large profile when implanted and thus increase disc
height.
[0155] The reinforcing members 510/520/530 may be used singularly
or in groups, depending on the increase in disc 50 height desired
and/or the amount of reinforcement of the annulus 52 desired. For
example, the reinforcing members 510/520/530 may be stacked or
inserted side-by-side. In addition, the reinforcing members
510/520/530 may be located in virtually any portion of the annulus
52. Preferably, the reinforcing members 510/520/530 are
substantially symmetrically disposed about the median plane 70 to
avoid causing curvature of the spine 10. Although the reinforcing
members 510/520/530 may be inserted, in part or in whole, into the
nucleus 54, it is preferable to insert them into the annulus 52 for
purposes of stability and load carrying. Specifically, to provide
stability, it is desirable to symmetrically locate the reinforcing
members 510/520/530 as far as reasonably possible from the median
plane 70, or to span as great a distance as possible across the
median plane 70. In addition, because the annulus 52 of the disc 50
is believed to carry the majority of the load, particularly in the
lumbar region 12, the reinforcing members 510/520/530 are
preferably placed in the annulus 52 to assume the load normally
carried thereby, and reinforce the load bearing capacity of the
annulus 52, without hindering the normal mobility function of the
disc 50.
[0156] The reinforcing members 510/520/530 may comprise expandable
members such as self-expanding members 510 or inflatable members
520. Alternatively, the reinforcing members 510/520/530 may
comprise unexpandable members such as reinforcement bars 530. When
implanting each type of reinforcement member 510/520/530, it is
preferable to maintain the integrity of the annulus 52.
Accordingly, space in the annulus 52 for the reinforcing members
510/520/530 is preferably established by dilation or the like,
although some amount of tissue removal may be used.
[0157] The expandable reinforcement members 510/520 are useful
because they may be delivered in a low profile, unexpanded
condition making it easier to traverse the very tough and fibrous
collagen tissue of the annulus 52. For similar reasons, the
reinforcement bars 530 are useful because they may have a small
diameter and a sharpened tip. Although it is possible to insert the
expandable reinforcing members 510/520 into the annulus 52 in their
final expanded state, it is desirable to deliver the expandable
reinforcing members 510/520 into the annulus 52 in an unexpanded
state and subsequently expand them in order to minimize
invasiveness and resistance to insertion.
[0158] The self-expanding reinforcing member 510 may comprise a
solid or semi-solid member that self-expands (e.g., by hydration)
after insertion into the annulus. Examples of suitable materials
for such solid or semi-solid members include solid fibrous collagen
or other suitable hard hydrophilic biocompatible material. If the
selected material is degradable, the material may induce the
formation of fibrous scar tissue which is favorable. If
non-degradable material is selected, the material must be rigid and
bio-inert. The self-expanding reinforcing member 510 preferably has
an initial diameter that is minimized, but may be in the range of
25% to 75% of the final expanded diameter, which may be in the
range of 0.3 to 0.75 cm, or 10% to 75% of the nominal disc height.
The length of the self-expanding member 510 may be in the range of
1.0 to 6.0 cm, and preferably in the range of 2.0 to 4.0 cm.
[0159] The inflatable reinforcing member 520 may comprise an
expandable hollow membrane capable of inflation after insertion
into the annulus. An example of a suitable inflatable structure is
detachable balloon membrane filled with a curable material. The
membrane may consist of a biocompatible and bio-inert polymer
material, such as polyurethane, silicone, or
polycarbonate-polyurethane (e.g., Corethane). The curable filler
material may consist of a curable silicone or polyurethane. The
filler material may be curable by chemical reaction (e.g.,
moisture), photo-activation (e.g., UV light) or the like. The cure
time is preferably sufficiently long to enable activation just
prior to insertion (i.e., outside the body) and permit sufficient
time for navigation and positioning of the member 520 in the disc.
However, activation may also take place inside the body after
implantation. The inflatable reinforcing member 520 preferably has
an initial deflated diameter that is minimized, but may be in the
range of 25% to 75% of the final inflated diameter, which may be in
the range of 0.3 to 0.75 cm, or 10% to 75% of the nominal disc
height. The length of the inflatable member 520 may be in the range
of 1.0 to 6.0 cm, and preferably in the range of 2.0 to 4.0 cm.
[0160] The reinforcement bars 530 may comprise a rigid, solid or
hollow bar having a sharpened tip. The reinforcement bars 530 may
comprises stainless steel mandrels, for example, having a diameter
in the range of 0.005 to 0.100 inches, preferably in the range of
0.010 to 0.050 inches, and most preferably in the range of 0.020 to
0.040 inches, and a length in the range of 1.0 to 6.0 cm, and
preferably in the range of 2.0 to 4.0 cm. The reinforcement bars
530 may be straight for linear insertion, or curved to gently wrap
with the curvature of the annulus during insertion. In addition,
the outer surface of the reinforcement bars 530 may have circular
ridges or the like that the permit easy insertion into the annulus
52 but resist withdrawal and motion in the annulus following
implantation. Other suitable materials for reinforcement bars 530
include titanium alloy 6-4, MP35N alloy, or super-elastic
nickel-titanium alloy.
[0161] With general reference to FIGS. 20A-20J, the steps for
implanting a self-expanding reinforcement member 510 are
illustrated. It should be understood that the procedure for
implanting a single member 510 in the anterior annulus 52 is shown
for purposes of illustration, not limitation. All of the variables
with regard to quantity, location, orientation, etc. discussed
previously may be implemented by varying the generic procedure
described hereinafter.
[0162] Initially, the sharpened stylet 430, semi-rigid needle 420
and rigid trocar 410 are assembled. As shown in FIG. 20A, the
distal portion of the assembly 410/420/430 is inserted into the
disc 50 as in a conventional discogram procedure. The assembly
410/420/430 is advanced until the distal tip 413 of the rigid
needle is proximate the anterior curvature of the annulus 52, near
the anterior side of the nucleus 54, as seen in FIG. 20B. The
semi-rigid needle 420 (alone or with stylet 430) is advanced
relative to the rigid trocar 410 until the curved portion 426 of
the semi-rigid needle exits the distal tip 413 of the rigid trocar
410 and the desired amount of curvature is established, as seen in
FIG. 20C. The curved portion 426 may be advanced until the tip 423
is substantially parallel to the tangent of the anterior annulus 52
curvature. The sharpened stylet 430 is advanced relative to the
semi-rigid needle 420 to the desired position within the anterior
annulus 52, as shown in FIG. 20D. The semi-rigid needle 420 and the
rigid trocar 410 are completely withdrawn from the stylet 430,
leaving the stylet in position as shown in FIG. 20E.
[0163] A flexible dilator 470 is advanced over the stylet 430 to
dilate the annulus 52, as seen in FIG. 20F. The flexible dilator
470 is similar to semi-rigid needle 420 except that the dilator
includes a blunt distal tip and is relatively more flexible, and
has larger inner and outer diameters. Note that one or more
dilators 470 may be advanced co-axially about the stylet 430 until
the annulus is sufficiently dilated to accept the self-expandable
member 510. The stylet 430 is then withdrawn from the flexible
dilator 470 and the self-expandable member 510 is introduced into
the lumen of the flexible dilator 470 using a push bar 480, as
shown in FIG. 20G. Alternatively, the dilator 470 may be removed in
favor of a flexible hollow catheter with a large inner diameter to
facilitate delivery of member 510. The push bar 480 is similar to
stylet 430 except that the distal tip of the push bar 480 is blunt.
Alternatively, the push bar 480 may simply comprise the stylet 430
turned around, thus using the proximal blunt end of the stylet 430
as the push bar 480. The push bar 480 is advanced until the member
510 is in the desired position, as seen in FIG. 20H. To facilitate
positioning the member 510, radiographic visualization may be used
to visualize the distal end of the push bar 480, which is formed of
radiopaque material and may include radiopaque markers. In
addition, the member may be loaded with a radiopaque material to
facilitate radiographic visualization thereof.
[0164] After the member 510 is in the desired position, the
flexible dilator 470 is retracted from the push bar 480 while
maintaining position of the member 510 with the push bar. The push
bar 480 is then removed leaving the member 510 in place. If
necessary, the procedure may be repeated for additional member
implants 510. The member 510 is then allowed to expand over time,
perhaps augmented by placing the spine 10 in traction.
Alternatively, the spine 10 may be placed in traction prior to
beginning the procedure.
[0165] With reference to FIGS. 20K-20L, the steps for implanting an
inflatable reinforcement member 520 are illustrated. In this
procedure, the steps outlined with reference to FIGS. 20A-20F are
followed. Specifically, the same steps are followed up to and
including the step of advancing the flexible dilator 470 over the
stylet 430 to dilate the annulus 52, and thereafter removing the
stylet 430 from the flexible dilator 470. Using a catheter 490, the
inflatable member 520 is introduced into the dilator 470 and
advanced until the member 520 is in the desired position, as shown
in FIG. 20K. The inflatable member 520 is connected to the distal
end of the catheter 490, which includes a flexible but pushable
shaft 492 and an inflation port 494. The flexible dilator 470 is
retracted from the catheter 490 while maintaining position of the
member 520.
[0166] With the member 520 in the desired position, which may be
confirmed using radiographic visualization as described above, the
proximal inflation port 494 is connected to a syringe (not shown)
or other suitable inflation apparatus for injection of the curable
filler material. The filler material is then activated and the
desired volume is injected into the catheter 490 via the inflation
port 494, as seen if FIG. 20L. The filler material is allowed to
cure and the catheter 490 is gently torqued to break the catheter
490 from the solid member 520. This break-away step may be
facilitated by an area of weakness at the juncture between the
distal end of the catheter 490 and the proximal end of the member
520. The catheter 490 is then removed leaving the member 520 in
place. If necessary, the procedure may be repeated for additional
member implants 520.
[0167] With reference to FIGS. 20M-20R, the steps for implanting a
reinforcement bar 530 are illustrated. As seen in FIG. 20M, the
disc 50 includes a protrusion or bulge 60, which is preferably, but
not necessarily, reduced or eliminated before insertion of the
reinforcement bar 530. This may be done by separating the adjacent
vertebrae 20. In order to establish separation of the vertebrae 20,
the spine 10 may be placed in traction or conventional
intervertebral separation tools may be used. After the bulge 60 is
reduced or eliminated, similar steps are followed as outlined with
reference to FIGS. 20A-20C.
[0168] Delivery of a single reinforcement bar 530 into the
posterior annulus 52 is illustrated. Specifically, the distal
portion of the assembly 410/420/480 is inserted into the disc 50 as
in a conventional discogram procedure. The assembly 410/420/480 is
advanced until the distal tip 413 of the rigid trocar 410 just
penetrates the posterior side of the annulus 52, as seen in FIG.
20N. The semi-rigid needle 420 (alone or with bar 530) is advanced
relative to the rigid trocar 410 until the curved portion 426 of
the semi-rigid needle 420 exits the distal tip 413 of the rigid
trocar 410 and the desired amount of curvature is established, as
shown in FIG. 20N. The curved portion 426 may be advanced until the
tip 423 is substantially parallel to the posterior annulus 52.
[0169] Using the push bar 480, the reinforcement bar 530 with its
sharpened tip is pushed into the annulus 52 as seen in FIG. 200.
The reinforcement bar 530 is advanced into the annulus 52 with the
push bar 480 until the bar 530 is in the desired position, as seen
in FIG. 20P, which may be confirmed using radiographic
visualization as described above. The push bar 480 is then
retracted, leaving the reinforcement bar 530 in place, as shown in
FIG. 20P. The semi-rigid needle 420 and the rigid trocar 410 are
then removed, as shown in FIG. 20Q, or, if necessary, the procedure
may be repeated for additional reinforcement bar implants 530, as
shown in FIG. 20R. Presence of the reinforcement bars 530 serves to
keep the disc 50, and particularly the bulge 60, in a more normal
condition, and to protect against continued bulging, thus easing
nerve impingement.
[0170] With reference to FIGS. 21A-21C, an alternative
reinforcement member 540 is illustrated. In this embodiment,
reinforcement member 540 includes an anchor arm 542 having an
anchor mechanism 544 attached to a distal end thereof. The anchor
mechanism 54 may comprise circular ridges, barbs or the like which
are readily advanced into the annular tissue 52, but resist
retraction. Reinforcement member 540 also includes a lever arm 546
including a distal sharpened tip 548. The distal end of the anchor
arm 542 also incorporates a sharpened tip 548. The reinforcement
member 540 preferably comprises a highly elastic or super-elastic
metal such as stainless steel or a nickel titanium alloy.
[0171] FIG. 21A illustrates the reinforcement member in a relaxed
state, and FIG. 21B illustrates the reinforcement member in a
compressed delivery state sized to fit within trocar 410. The
reinforcement member 540 may be delivered into the annulus 52 in a
compressed state through trocar 410 utilizing push rod 480 as shown
in FIG. 21C. As the reinforcement member 540 is pushed out the
distal end of the trocar 410 utilizing push rod 480, the sharpened
ends 548 penetrate the tissue and the anchor mechanism 544 engages
the tissue to define the deployed configuration shown in FIG. 21C.
In the deployed configuration, the anchor arm and the lever arm are
forced to pivot relative to each other thereby building a bias
force at the elbow connecting the anchor arm 542 and the lever arm
546. In the deployed configuration, the lever arm 546 applies a
compressive force to the exterior portion of the annulus 52 to
minimize protrusions and bulges along the posterior periphery of
the annulus 52.
[0172] With reference now to FIGS. 22A-22D, alternative
reinforcement members 570 and 580 are illustrated. Reinforcement
members 570 and 580 are similar to reinforcement 600 except for the
provision of distal anchors 574/584. Except as described herein and
apparent from the drawings, the function and delivery of
reinforcement members 570 and 580 are substantially the same as
reinforcement member 600.
[0173] As shown in FIG. 22A, reinforcement member 570 comprises a
monofilament or multifilament structure 572 that is highly flexible
and has a high tensile strength. The ends of the filament structure
572 incorporate anchors 574, which may comprise circular ridges,
barbs or the like which are readily advanced into the annular
tissue 52, but resist retraction. As shown in FIG. 22B, the
reinforcement member 570 may be deployed in the annulus 52 with the
anchors residing in healthy annular tissue and the filament
structure partially surrounding the fractures and fissures 56/58 in
a circumferential manner. By advancing the anchors 574 during
deployment, the annular tissue 52 is compressed along the length of
the filament structure 572, thereby closing fractures and fissures
56/58 and reducing posterior protrusions.
[0174] A similar arrangement is shown in FIGS. 22C and 22D. In this
embodiment, a reinforcement member 580 comprises a monofilament or
a multifilament structure 582 having a single distal anchor 584
attached thereto. The proximal end of the filament structure 582 is
otherwise free. During implantation, one or more reinforcement
members 580 may be utilized as shown in FIG. 22D. The free ends of
the filament structure 582 are connected using, for example, a knot
586 with or without the use of a pledget 750.
[0175] Refer now to FIGS. 23A and 23B which illustrate an
alternative method for implanting a variation of the reinforcement
member 510, and optionally utilize another reinforcement member 600
to anchor reinforcement member 510 in place. Reinforcement member
510 may be implanted in a void left by discectomy utilizing a
method such as described with reference to FIGS. 20A-20L. Other
reinforcement members may used in place of reinforcement member 510
such as reinforcement members 100/200. Other reinforcement members
may optionally be used as anchor means. By way of example, not
limitation, reinforcement member 600 is shown as a means to anchor
reinforcement member 510 relative to the annulus 52 utilizing a
method such as described with reference to FIGS. 25A-25J or FIGS.
27A-27H, for example.
[0176] Following a discectomy, a portion of the annulus 52 is
typically removed as shown in FIG. 23A. The void left by the
discectomy procedure may expose the disc 50 to increased stress due
to loss of surface area and/or leakage of fluid from the nucleus
54. By implanting a reinforcement member 510 in the void as seen in
FIG. 23B, the reinforcement member 510 acts as a barrier to nuclear
leakage and acts as a support member to minimize disc height loss.
Reinforcement member 510 acts as a support to adjacent vertebrae by
having a height substantially equal to the nominal height of the
disc (in a healthy state) and by providing an expanded volume
substantially equal to the void, to thereby share the load of
adjacent vertebrae. This combination of functions (barrier and
volume) reduces the rate of degeneration or possibly eliminates
further degeneration of the disc 50.
[0177] Refer now to FIGS. 24A-24E which illustrate various tools
760/770 for implanting the reinforcement member 600 in accordance
with the method illustrated in FIGS. 25A-25J. As seen in FIG. 24A,
dual tube trocar 760 includes two rigid tubes 762 formed of
stainless steel, for example, secured to a handle 764. The tubes
762 may be substantially the same size and symmetric. Each tube 762
includes a sharpened tip 763 and a lumen (not visible) fully
extending therethrough to slidably accommodate stylet 770 shown in
FIG. 24B. The lumen of the second tube 762 which accommodates
reentry of the stylet 770 may be made even larger (e.g., 2-3 times)
to permit variability in reentry as will be discussed in more
detail hereinafter. A bracket 766 may be disposed between the rigid
tubes 762 to maintain spacing and alignment therebetween.
[0178] With reference to FIG. 24B, stylet 770 is substantially the
same as stylet 710 described previously. Stylet 770 includes an
elongate flexible shaft 772 and a sharpened distal end 773. The
stylet or needle 770 has a curved portion 774 with a diameter
substantially equal to the distance between the centerlines of the
tubes 762 of the trocar 760. The curved portion 774 preferably has
at least 180 degrees of curvature or more to define at least a full
semi-circle. The shaft 772 of the stylet 770 preferably has a
flexible but pushable construction incorporating a rigid metal
mandrel such as stainless steel, or a super-elastic alloy such as
nickel-titanium. Highly elastic or super-elastic materials
incorporated into the elongate shaft 772 resist permanent
deformation during insertion and navigation through the annulus 52.
The shaft 772 of the stylet 770 may have a diameter ranging from
0.010 to 0.025 inches and is sized to fit within the lumens of the
tubes 762 of the trocar 760. The shaft 772 may be coated with a
lubricious material such as PTFE and a hydrophilic polymer.
[0179] If the tip 773 is sufficiently sharp to easily penetrate
annular tissue 52, the path through the annular tissue 52 taken by
the stylet 770 will substantially conform to the geometry of the
distal curved portion 774 of the stylet 770. In particular, if the
distal portion 774 has a curve with a diameter substantially equal
to the distance between the centerlines of the tubes 762 of the
trocar 760, the stylet 770 will exit the distal end of one tube 762
and naturally define a path through the annular tissue 52 to
reenter the distal end of the other tube 762. To this end, it is
desirable to provide a tip 773 having sufficient sharpness to
readily penetrate annular tissue 52, which tends to be relatively
fibrous and tough. By providing a sufficiently sharp tip 773, the
stylet 770 will naturally navigate through the annulus 52 from the
end of one tube 762 into the end of the other tube 762, without
requiring visualization or steering of the stylet 770.
[0180] Refer now to FIGS. 24C and 24D which illustrate alternative
dual tube trocar 760 designs which utilizes means 765/767 to ensure
proper alignment of the stylet 700 as it exits the distal end of
one of the tubes 762. In particular, in order for the stylet 770 to
reenter the distal end of the second tube 762, the stylet 770
preferably exits the distal end of the first tube 762 with the
curved portion 774 of the stylet 770 in substantially the same
plane as the two tubes 762. This may be accomplished manually by
rotating the stylet 770 prior to exit from the first tube 762, or
this may be accomplished automatically by providing a keyed
passageway or by providing mechanisms 765/767.
[0181] Because the curved portion 774 will align itself with any
curvature provided in the lumen of the tubes 762, the distal end of
one or both of the tubes 762 may be provided with a gentle
curvature 765 as seen in FIG. 24C which will provide a
corresponding curvature to the lumen extending therethrough.
Alternatively, the distal end of one of the tubes 762 may be
provided with an indentation 767 as seen in FIG. 24D which will
define a corresponding curved path in the lumen extending
therethrough. In particular, with reference to FIG. 24E, the indent
767 impinges on an inner tube 768 which is otherwise centered in
the lumen of the tube 762 by collars 769. By virtue of the indent
762, the lumen 761 defined through the inner tube 768 is provided
with a curved path. Whether provided by a curve in the tube 762, by
an indent 762 impinging on an inner tube 768, or by other means to
define a curved path within the tube 762, the curved portion 774 of
the stylet will naturally align itself with such a curvature,
thereby automatically providing alignment between the stylet 770
and the second tube 762 as the distal end of the stylet 770
reenters the trocar 760 as will be described in more detail
hereinafter.
[0182] Refer now to FIGS. 25A-25J which illustrate an alternative
method for implanting the reinforcement member 600. The method
illustrated in FIGS. 25A-25J utilizes stylet 770 to navigate
through the annulus 52 and implant reinforcement member 600. The
method illustrated in FIGS. 25A-25J is similar to the method
illustrated in FIGS. 18A-18L, except with regard to path defined by
reinforcement member 600 and the automatic navigation of stylet 770
out of and into the trocar 760. The method illustrated in FIGS.
25A-25J is particularly suited for a post discectomy procedure to
close the opening (not shown) created thereby. Further, the method
illustrated in FIGS. 25A-25J is particularly suited for a post
annular compression procedure (e.g., contraction of annular tissue
by thermal means) to maintain the re-compressed annulus (not shown)
created thereby. All of the variables with regard to quantity,
location, orientation, etc., discussed previously may be
implemented by varying the generic procedure described hereinafter.
The method illustrated in FIGS. 25A-25J is a percutaneous procedure
in which access to the disc 50 is achieved utilizing a number of
small diameter tools which may be inserted through a patient's back
(skin and back muscles), between adjacent vertebrae, and adjacent
the patient's disc 50.
[0183] Initially, as shown in FIG. 25A, the rigid dual tube trocar
760 is advanced until the distal tips thereof are disposed in the
anterior portion of the annulus 52. The stylet 770 is then inserted
into the first tube 762 of the rigid dual tube trocar 760. The
stylet 770, having a curved distal portion 774, is advanced out the
distal end of the first tube 762 into the annulus 52 as shown in
FIG. 25B. The stylet 770 is advanced until the distal tip 773
reenters the trocar 760 at the distal end of the second tube 762 as
shown in FIG. 25C. Note that the curvature 774 corresponds to the
distance between the centerlines of the tubes 762, and that the
curvature 774 is at least semi-circular (180 degrees or more) to
thereby automatically reenter the trocar 760 at the distal end of
the second tube 762.
[0184] The stylet 770 is advanced until the distal tip 773 exits
the proximal end of the second tube 762 as shown in FIG. 25D. One
end of the reinforcement member 600 is attached to the proximal end
of the stylet 770 as shown in FIG. 25E. This may be accomplished,
for example, by threading the reinforcement member through a hole
(not shown) in the proximal end of the stylet 770 similar to the
threading a sewing needle. The distal end of the stylet 770 is
pulled proximally to pull the stylet out of the trocar 760 and
thread the reinforcement member 600 along the path defined by the
stylet 770 as shown in FIG. 25F. At this point, the trocar 760 may
be removed as shown in FIG. 25H, but may optionally be left in
place, depending on the means employed to connect the ends of the
reinforcement member 600.
[0185] Although not shown, immediately before or immediately after
the reinforcement member 600 is attached to the proximal end of the
stylet 770, the pledget push rod 740 may be used to push the
pledget 750 over the opposite ends of the reinforcement member 600
until the pledget 750 is positioned immediately adjacent the entry
and exit points in the annulus 52. A connection (e.g., knot) 610
may be made in the reinforcement member 600 and advanced to the
entry points of in the annulus 52 utilizing a conventional knot
pusher (not shown) as shown in FIG. 25I. While the knot 610 is
being tightened, the reinforcement member 600 applies compressive
forces about the annulus 52 thereby closing fractures and fissures
56. Once the knot 610 has been tightened, the reinforcement member
600 may be cut immediately proximal of the knot 610 (proximal of
pledget 750 if used) as shown in FIG. 25J utilizing a conventional
suture cutting device (not shown).
[0186] Refer now to FIGS. 26A-26G which illustrate various tools
780/790/840 for implanting the reinforcement member 600 in
accordance with the method illustrated in FIGS. 27A-27H. As seen in
FIG. 26A, a dual lumen trocar 780 includes a dual lumen shaft 782
and a proximal handle 784. Rigid shaft 782 includes a sharpened tip
783 and a laterally facing opening 785. The rigid shaft 782 may be
formed of stainless steel and may comprises a rigid outer tube 788
and a rigid inner tube 786 disposed eccentrically therein as seen
in FIG. 26B. Inner tube 786 defines a lumen 787 extending through
the entire shaft 782 and is sized to accommodate hollow stylet 790.
A crescent-shaped lumen 789 is defined between the outer tube 788
and the inner tube 786. The crescent-shaped lumen 789 extends
through the entire shaft 782 and is sized to accommodate hollow
stylet 790. Opening 785 is also sized to accommodate the hollow
stylet 790, and may be made even larger (e.g., 2-3 times larger) to
accommodate variability in reentry as will be discussed in more
detail hereinafter.
[0187] With reference to FIGS. 26C and 26D, hollow stylet 790 is
substantially the same as stylet 710 except as described herein and
illustrated in the drawings. Hollow stylet 790 includes an elongate
flexible shaft 792 and a sharpened distal end 793. A lumen 791
extends through the entire shaft 792 and is sized to accommodate
reinforcement member 600.
[0188] The shaft 792 of the hollow stylet 790 preferably has a
flexible but pushable construction incorporating a rigid metal tube
such as stainless steel hypotubing, or a super-elastic alloy tube
such as nickel-titanium. Highly elastic or super-elastic materials
incorporated into the elongate shaft 792 resist permanent
deformation during insertion and navigation through the annulus 52.
The shaft 792 of the stylet 790 may have a diameter ranging from
0.010 to 0.025 inches and is sized to fit within the lumens 787/789
of the shaft 792 of the trocar 790. The shaft 792 may be coated
with a lubricious material such as PTFE and a hydrophilic
polymer.
[0189] The stylet or needle 790 has a curved portion 794 and a
separable curved tip 796. The separable curved tip 796 is connected
to the reinforcement member 600 as shown in FIGS. 26E and 26F, but
is separable from the remainder of the shaft 792. The curved
portion 794 and the separable curved tip 796 may have the same
diameter which may vary as described with reference to curved
portion 712 of stylet 710 shown in FIGS. 12A-12E. The curved
portion 774 together with separable tip 796 may have at least 360
degrees of curvature or more to define at least a full circle. Two
example curvatures of the separable curved tip 796 are shown in
FIGS. 26E and 26F.
[0190] The tip 793 of the hollow stylet 790 is sufficiently sharp
to easily penetrate annular tissue 52, such that the path through
the annular tissue 52 taken by the hollow stylet 790 will
substantially conform to the geometry of the distal curved portion
794 and the curved separable tip 796. In particular, if the distal
curved portion 794 and the curved separable tip 796 have a curve
with at least 360 degrees of curvature or more, the hollow stylet
790 will exit the lumen 787 at the distal end of the inner tube 786
and naturally define a path through the annular tissue 52 to
reenter the trocar 780 through opening 785 and into the lumen 789
of the outer tube 788. To this end, it is desirable to provide a
tip 793 having sufficient sharpness to readily penetrate annular
tissue 52, which tends to be relatively fibrous and tough. By
providing a sufficiently sharp tip 793 with the appropriate
geometry described above, the stylet 790 will naturally navigate
through the annulus 52 and renter the trocar 780 without requiring
visualization or steering of the stylet 790.
[0191] Push rod 840 may comprise a rigid mandrel having a length
sufficient to extend through the shaft 782 of the trocar 780 and a
diameter sufficient to permit passage through lumen 789. The distal
end of the push rod 840 is adapted to engage the separable tip 796
as it renters the trocar 780 through opening 785, and lock the tip
796 relative to shaft 782 by mechanical compression, for
example.
[0192] Refer now to FIGS. 27A-27H which illustrate a method for
implanting the reinforcement member 600. The method illustrated in
FIGS. 27A-27H utilizes hollow stylet 790 to navigate through the
annulus 52 and implant reinforcement member 600. The method
illustrated in FIGS. 27A-27H is similar to the method illustrated
in FIGS. 18A-18L, except with regard to the automatic navigation of
stylet 770 out of and back into the trocar 780. The method
illustrated in FIGS. 27A-27H is particularly suited for a post
discectomy procedure to close the opening (not shown) created
thereby. Further, the method illustrated in FIGS. 27A-27H is
particularly suited for a post annular compression procedure (e.g.,
contraction of annular tissue by thermal means) to maintain the
re-compressed annulus (not shown) created thereby. All of the
variables with regard to quantity, location, orientation, etc.,
discussed previously may be implemented by varying the generic
procedure described hereinafter. The method illustrated in FIGS.
27A-27H is a percutaneous procedure in which access to the disc 50
is achieved utilizing a number of small diameter tools which may be
inserted through a patient's back (skin and back muscles), between
adjacent vertebrae, and adjacent the patient's disc 50.
[0193] Initially, as shown in FIG. 27A, the rigid dual lumen trocar
780 is advanced until the distal tip thereof is disposed in the
anterior portion of the annulus 52. The hollow stylet 790 is then
inserted into the inner tube 786 of the rigid dual lumen trocar
780. The hollow stylet 790, having a curved distal portion 794 and
separable tip portion 796, is advanced out the distal end of the
shaft 782 into the annulus 52 as shown in FIG. 27B. The hollow
stylet 790 is advanced until the distal tip 793 reenters the trocar
780 through the opening 785 at the distal end shaft 782 as shown in
FIG. 27B. Note that the curvature of the curved portion 794, the
curvature of the separable tip 796 is selected to automatically
align with the opening 785 and thereby automatically reenter the
trocar 780.
[0194] The proximal portion of the shaft 792 of the hollow stylet
790 is then withdrawn leaving separable tip 796 and reinforcement
member 600 in place as shown in FIG. 27C. The push rod 840 is then
advanced into the trocar 780 through lumen 789 until its distal end
mechanically engages tip 796 and pinches or traps it relative to
the distal end of the shaft 782 of the trocar 780 as shown in FIG.
27D. The proximal end of the push rod 840 and the handle 784 of the
trocar are then grasped and pulled proximally while maintaining
engagement of the distal end of the push rod 840 against the
separable tip 796. As the proximal end of the push rod 840 and the
handle 784 of the trocar are pulled proximally, the reinforcement
member 600 is not grasped or otherwise restrained such that the
reinforcement member 600 is free to be advanced distally and
threaded along the path previously defined by hollow stylet 790 as
shown in FIG. 27E.
[0195] Although not shown, the pledget push rod 740 may be used to
push the pledget 750 over the opposite ends of the reinforcement
member 600 until the pledget 750 is positioned immediately adjacent
the entry and exit points in the annulus 52. A connection (e.g.,
knot) 610 may be made in the reinforcement member 600 and advanced
to the entry points of in the annulus 52 utilizing a conventional
knot pusher (not shown). While the knot 610 is being tightened, the
reinforcement member 600 applies compressive forces about the
annulus 52 thereby closing fractures and fissures 56 and reducing
bulge 60. Once the knot 610 has been tightened, the reinforcement
member 600 may be cut immediately proximal of the knot 610 (or
proximal of pledget 750 if used) as shown in FIG. 27F utilizing a
conventional suture cutting device (not shown).
[0196] While a single path followed by a single reinforcement
member 600 is illustrated in FIGS. 27A-27F, it is also contemplated
that multiple reinforcement members 600 may be implanted as shown
in FIG. 27G. For example, one reinforcement member 600 could be
implanted proximate the lower (inferior) portion of the annulus 52
and one reinforcement member 600 could be implanted in the upper
(superior) portion of the annulus 52. Any number of reinforcement
members 600 could be implanted in a single disc, either through a
single trocar 780 placement, or multiple trocar placements.
[0197] The path navigated through the annulus 52 by the foregoing
method may be a function of the individual anatomical geometry of
the patient and/or the particular portion of the annulus 52
requiring compression. Accordingly, the path defined by the stylet
790 and reinforcement member 600 through the annulus 52 may vary as
shown in FIGS. 19A-19F by utilizing different stylet 790 curvatures
and a sheath, similar to the method described with reference to
FIGS. 18A-18L. By way of example, not limitation, a substantial
rectangular path with rounded corners may be employed as
illustrated in FIG. 27H.
[0198] From the foregoing, those skilled in the art will appreciate
that the present invention provides reinforcement devices 100, 200,
300, 600, 510, 520, 530, 540, 570 and 580, which may be used to
reinforce a damaged disc, while permitting relative movement of the
adjacent vertebrae. The present invention also provides minimally
invasive methods of implanting such devices as described above.
[0199] All of the implantable devices and delivery tools therefor
described above may incorporate heating mechanisms (e.g., resistive
wire coils) to allow for heating the surrounding tissue, such as
temporarily and directly heating annular tissue. In addition or in
the alternative, a separate device may be provided specifically for
heating annular tissue, which may be used to accomplish results
similar to those described with reference to FIG. 4H. By way of
example, not limitation, the following is a description of a device
specifically adapted to heat annular tissue, but the methods and
principles of operation are equally applicable to all devices
disclosed herein that come into contact with annular tissue.
[0200] FIG. 28A illustrates an exemplary embodiment of a thermal
probe 1010 which may be temporarily positioned within the annulus
and heated. The thermal probe 1010 may comprise a hollow shaft
1015, which contains a heating element extending at least a portion
of the length of the shaft 1015. The thermal probe 1010 may be
advanced through the annulus over one or more stylets in the same
fashion as sheath 730 as described with reference to FIGS. 18A
through 18F utilizing one or a series of stylets 1035 incorporating
curvatures as shown and described with reference to FIGS. 12A
through 12E.
[0201] The heating element may comprise, for example, a coil or
braid of resistive metallic wire. As seen in FIG. 28B, a detailed
view of a distal portion of the probe 1010 is shown, which includes
a resistive wire coil 1020 encapsulated by the polymeric material
of the shaft 1015. The polymeric shaft material may comprise
electrically insulative material and may be selected to tolerate
relatively high temperatures, such as PTFE or polyimide. At the
distal end of the coil 1020, the resistive wire may extend
proximally as a return wire 1025. A plug 1030, connected to the
proximal end of the thermal probe 1010 may provide connection to a
power source (not shown). Direct or alternating current may be used
to electrify the resistive wire coil 1020, causing heating, which
in turn heats the annular tissue. Temperature may be controlled by
the amount of electric power delivered. One or more thermocouples
may be included in the shaft 1015 of the probe 1010 (not
shown).
[0202] An alternative probe 1040 is illustrated in FIG. 28C. The
stylet 1045 used for delivery of thermal probe 1040 could also be
used as the return electrode. As shown in FIG. 28C, the shaft 1050
includes a resistive coil 1055, terminating near the distal end at
a contact 1060. The contact 1060 provides electrical connection
between the stylet 1045 and the resistive wire coil 1055. In this
embodiment, the stylet 1045 may be electrically conductive, and is
preferably metallic. The stylet 1045 optionally includes a shoulder
1065 which allows for the probe 1040 to be advanced in a "fixed
wire" fashion, together with the stylet 1045. This "fixed wire"
approach incorporating an optional shoulder 1065 on the stylet 1045
is also applicable to the above described implants and delivery
devices, e.g. stylet 710 and sheath 730 illustrated in FIGS. 18A
through 18F.
[0203] The thermal probe 1010/1040 may be positioned directly
within the annulus, in the same manner as described in connection
with the positioning of the implant 100 shown in FIGS. 8A through
8K. But rather than implant 100, thermal probe 1010/1040 would be
positioned and activated. These figures illustrate positioning in
the posterior annulus, but it is within the scope of this invention
that the thermal probe 1010/1040 could be positioned anywhere
within the annulus or across the disc, including the positions
illustrated in FIGS. 19A through 19F. For example, the probe
1010/1040 could be positioned in the lateral annulus, anterior
annulus, or multiple regions of the annulus, including
circumferentially in the annulus, as illustrated for the sheath 730
illustrated in FIGS. 18A through 18F.
[0204] The thermal probe 1010/1040 may also incorporate an
anchoring mechanism to facilitate compression of the annular tissue
prior to heating. For example, the probe 1010/1040 could include
progressive external threads such as described in connection with
the implant of FIG. 4A.
[0205] Those skilled in the art will recognize that the present
invention may be manifested in a variety of forms other than the
specific embodiments described and contemplated herein.
Accordingly, departures in form and detail may be made without
departing from the scope and spirit of the present invention as
described in the appended claims.
* * * * *