U.S. patent application number 14/671021 was filed with the patent office on 2015-08-13 for device for treatment or evacuation of intervertebral disc.
The applicant listed for this patent is LEONARD EDWARD FORREST. Invention is credited to LEONARD EDWARD FORREST.
Application Number | 20150223878 14/671021 |
Document ID | / |
Family ID | 34969046 |
Filed Date | 2015-08-13 |
United States Patent
Application |
20150223878 |
Kind Code |
A1 |
FORREST; LEONARD EDWARD |
August 13, 2015 |
DEVICE FOR TREATMENT OR EVACUATION OF INTERVERTEBRAL DISC
Abstract
A method of positioning an arcuate tool against inner annular
walls of the disc that particularly facilitates reaching posterior
and postero-lateral portions of the inner annulus of the disc by
arthroscopy. An elongated, arcuate and shape memory tool such as a
catheter is positioned against the inner annular wall of the disc,
and particularly on the posterior and postero-lateral portions of
the inner annulus of the disc, which are portions of the disc to be
treated. The deformable and arcuate tool retains its predetermined
arcuate shape when no pressure or force is applied to the tool.
Inventors: |
FORREST; LEONARD EDWARD;
(Mt. Pleasant, SC) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
FORREST; LEONARD EDWARD |
Mt. Pleasant |
SC |
US |
|
|
Family ID: |
34969046 |
Appl. No.: |
14/671021 |
Filed: |
March 27, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13967926 |
Aug 15, 2013 |
8992479 |
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14671021 |
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13606559 |
Sep 7, 2012 |
8523820 |
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13967926 |
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13042984 |
Mar 8, 2011 |
8308690 |
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13606559 |
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11972815 |
Jan 11, 2008 |
7905863 |
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13042984 |
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11112475 |
Apr 23, 2005 |
7322962 |
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11972815 |
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60564838 |
Apr 23, 2004 |
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60572930 |
May 20, 2004 |
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60586627 |
Jul 9, 2004 |
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60588582 |
Jul 16, 2004 |
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60588587 |
Jul 16, 2004 |
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Current U.S.
Class: |
606/28 ; 606/1;
606/170; 606/41 |
Current CPC
Class: |
A61B 2017/00261
20130101; A61B 2018/0044 20130101; A61B 2017/00831 20130101; A61F
2/442 20130101; A61B 18/1492 20130101; A61B 17/8811 20130101; A61B
2017/00238 20130101; A61B 17/8816 20130101 |
International
Class: |
A61B 18/14 20060101
A61B018/14; A61B 17/88 20060101 A61B017/88; A61F 2/44 20060101
A61F002/44 |
Claims
1. A device for treatment or evacuation of an interior of a
mammalian intervertebral disc, comprising: an introducer comprising
a guide constructed an arranged for insertion through an opening in
a posterior wall of mammalian intervertebral disc; an elongated
tool formed of a shape memory material and comprising a preformed
arcuate shape, the elongated tool and guide constructed and
arranged for advancement of said elongated tool along said guide,
wherein said preformed arcuate shape of said elongated tool is
deformed by said guide while said preformed arcuate shape of the
elongated tool engages said guide, and wherein the elongated tool
is constructed and arranged to reassume its preformed arcuate shape
upon exiting the guide and while in the interior of the mammalian
intervertebral disc, and wherein the preformed arcuate shape of the
elongated tool is constructed and arranged for selectively
contacting substantially all surfaces of an interior of the wall of
the mammalian intervertebral disc from selective advancement and
retraction of the elongated tool within the interior of the
mammalian intervertebral disc with independent selective
advancement and retraction of the introducer.
2. A device for treatment or evacuation of an interior of a
mammalian intervertebral disc as described in claim 1, wherein said
guide comprises a lumen, and where said elongated tool slidably
engages said lumen as said elongated tool is transported into the
interior of the mammalian intervertebral disc through said
lumen.
3. A device for treatment or evacuation of an interior of a
mammalian intervertebral disc as described in claim 1, wherein said
elongated tool comprises a deformable locator tip on a distal end
of said elongated tool, wherein said deformable locator tip is
visible under a fluoroscope, and wherein said deformable locator
tip is constructed and arranged to deform upon contact under
pressure with the interior wall of the mammalian intervertebral
disc.
4. A device for treatment or evacuation of an interior of a
mammalian intervertebral disc as described in claim 1, wherein said
elongated tool is a catheter.
5. A device for treatment or evacuation of an interior of a
mammalian intervertebral disc as described in claim 1, wherein said
guide is a sheath.
6. A device for treatment or evacuation of an interior of a
mammalian intervertebral disc as described in claim 1, wherein said
elongated tool comprises a cutter.
7. A device for treatment or evacuation of an interior of a
mammalian intervertebral disc as described in claim 1, wherein said
elongated tool comprises a device for emitting radio frequency.
8. A device for treatment or evacuation of an interior of a
mammalian intervertebral disc as described in claim 1, wherein said
elongated tool comprises a device for emitting heat.
9. A device for treatment or evacuation of the interior of a
mammalian intervertebral disc as described in claim 1, wherein said
guide of said introducer comprises a substantially straight lumen
that forms said elongated tool as substantially straight as said
elongated tool slidably engages said lumen.
10. A device for treatment or evacuation of the interior of a
mammalian intervertebral disc as described in claim 1, wherein said
elongated tool is rotatable relative to the introducer and the
preformed arcuate shape of the elongated tool is constructed and
arranged for positioning on a side of the mammalian intervertebral
disc that is opposite a first side of the mammalian intervertebral
disc after rotation of the elongated tool relative to the
introducer.
Description
[0001] This application is a continuation of U.S. application Ser.
No. 13/967,926 filed Aug. 15, 2013, which is a continuation of U.S.
application Ser. No. 13/606,559 filed Sep. 7, 2012, now U.S. Pat.
No. 8,523,820, which is a divisional of U.S. application Ser. No.
13/042,984 filed Mar. 8, 2011, now U.S. Pat. No. 8,308,690, which
was a continuation of U.S. application Ser. No. 11/972,815 filed
Jan. 11, 2008, now U.S. Pat. No. 7,905,863, which was a
continuation of U.S. application Ser. No. 11/112,475 filed Apr. 23,
2005, now U.S. Pat. No. 7,322,962, which benefit is claimed hereby,
and which claimed priority on the following Provisional
applications:
[0002] Applicant claims the benefit of U.S. Provisional Application
Ser. No. 60/564,838 filed Apr. 23, 2004.
[0003] Applicant claims the benefit of U.S. Provisional Application
Ser. No. 60/572,930 filed May 20, 2004.
[0004] Applicant claims the benefit of U.S. Provisional Application
Ser. No. 60/586,627 filed Jul. 9, 2004.
[0005] Applicant claims the benefit of U.S. Provisional Application
Ser. No. 60/588,582 filed Jul. 16, 2004.
[0006] Applicant claims the benefit of U.S. Provisional Application
Ser. No. 60/588,587 filed Jul. 16, 2004.
FIELD OF INVENTION
[0007] This invention and method relate to the treatment or
evacuation of an intervertebral disc.
BACKGROUND OF THE INVENTION
[0008] The intervertebral disc is comprised of an outer annulus
fibrosis and an internal nucleus pulposus. The healthy annulus is
comprised of 10-20 lamellae forming a concentric ring of collagen
and elastic fibers around the nucleus while the healthy nucleus
pulposus is ovoid and composed of a gelatinous mucoprotein within
the confines of the annulus fibrosis.
[0009] In the healthy normal disc, the annulus is thick and the
internal wall is strong and without significant defects. Aging and
trauma cause multiple and varied defects of the annulus as well as
changes in the nucleus. These defects are a source of pain for many
individuals. It is widely accepted that the defects which actually
do cause pain are either posterior or postero-lateral. By far, it
is most common that symptomatic defects are posterior and/or
unilateral postero-lateral. Symptomatic defects which are posterior
and bilateral postero-lateral certainly do exist but are definitely
less common. On the other hand, degenerative changes with defects
along the inner annular wall can be found commonly in various other
segments of the inner annular wall (anteriorally, antero-laterally
on either or both sides, and laterally on either or both sides.
These defects are understood to be asymptomatic, but nevertheless
are common.
[0010] Radiofrequency is used to treat internal intervertebral disc
disruption. Forward pressure is applied to circumvent the nucleus
adjacent to the inner annular wall, leverage with the forward
pressure against the annular wall opposite to the portion
attempting to be treated, or drive through the annular tissue which
is intended to be treated.
[0011] The catheter is advanced around the inside of the nucleus
pulposus adjacent to the inner annular wall. However, in the
spectrum of discs requiring treatment, ideal discs are infrequently
encountered. The result is that the tip of the catheter, even with
a bent and/or capped tip gets caught in defects in the wall, making
the advancement difficult or impossible. This frequently results in
kinking of the catheter (which then typically must be removed),
lodging into the defect (presumably worsening the defect), going
through the annular wall (obviously creating a through and through
defect in the annular wall and even potentially puncturing or
damaging nerve or vascular structures), and ultimately making the
intended treatment suboptimal or even impossible. Additionally, in
such situations there has been further damage caused to the disc by
the catheter. The defects into which the catheter can inadvertently
probe can be the defect, or defects, intended to be treated.
Alternately, a defect in the anterior, antero-lateral, or lateral
wall can equally be entered inadvertently and cause a disruption of
the procedure. Degenerative disc walls commonly contain multiple
such defects, as well as thinning of the wall, which are all too
frequently penetrated.
SUMMARY OF THE INVENTION
[0012] The invention includes a method of positioning an S-shaped
tool against inner annular walls of the disc, and particularly on
the posterior and postero-lateral portions of the inner annulus of
the disc, by arthroscopy. The apparatus used according to one
method requires no forward tip pressure on the inner annular wall
of a mammalian intervertebral disc. An arcuate and S-shaped tool
such as a catheter is positioned against the inner annular wall of
the disc, and particularly on the posterior and postero-lateral
portions of the inner annulus of the disc, which are specifically
the portions which need to be treated. The arcuate and S-shaped
tool retains its predetermined arcuate and S-shape shape when no
pressure or force is applied to the tool.
[0013] In another embodiment an arcuate and S-shaped device such as
a sheath is used to progressively remove material from the interior
of the mammalian intervertebral disc. In yet another embodiment, an
arcuate and S-shaped tool device such as a sheath and catheter are
used to remove the entire intervertebral disc and place supports to
maintain a disc space.
DESCRIPTION OF THE DRAWINGS
[0014] FIG. 1 shows a partial lateral view of a portion of a human
spine.
[0015] FIG. 2 is a sectioned view taken essentially along line 2-2
of FIG. 1.
[0016] FIG. 3 is an exploded view showing the introducer needle,
non-conductive sheath, stylet and catheter.
[0017] FIG. 4 shows the introducer needle with stylet in place and
having penetrated the annular wall of the disc.
[0018] FIG. 5 shows the introducer needle with the stylet
removed.
[0019] FIG. 6 shows the non-conductive sheath inserted into and
through the introducer needle, with the S-shaped catheter advanced
through the sheath.
[0020] FIG. 7 shows the S-shaped catheter extended as required
through the sheath.
[0021] FIG. 8 demonstrates the introducer needle and sheath being
retracted to position the catheter.
[0022] FIG. 9 shows the introducer needle and sheath retracted, and
the catheter positioned against the inner annular wall defect.
[0023] FIG. 10 demonstrates the device being withdrawn from the
disc and the iatrogenically created defect being sealed.
[0024] FIG. 11 demonstrates a range of permissive angles of
insertion of the introducer needle relative to the disc.
[0025] FIG. 12 demonstrates the introducer needle penetrating the
annular wall at a different angle from that shown in FIGS. 4
through 10.
[0026] FIG. 13 demonstrates another angle of entry of the
introducer needle into the disc.
[0027] FIG. 14 demonstrates a catheter having multiple orifices
therein through which materials may be dispensed.
[0028] FIG. 15 is a sectioned view of an introducer needle inserted
into a sheath having ports therein.
[0029] FIG. 16 is a sectioned view of an introducer needle having
ports through which materials may be inserted into the disc, or
from which materials may be removed, such as by vacuuming, and also
showing a cutter therein.
[0030] FIG. 17 demonstrates an introducer needle and stylet
penetrating a disc.
[0031] FIG. 18 demonstrates the flexible tip bending on contact
with the inner annular wall.
[0032] FIG. 19 demonstrates a cutter which may be used to remove
material from the disc.
[0033] FIG. 20 demonstrates removal of a path of disc material
using a cutter and a lavage/suction.
[0034] FIG. 21 demonstrates a progressive step in removing material
from the disc.
[0035] FIG. 22A and FIG. 22B demonstrate additional progressive
steps in removing material from the disc.
[0036] FIG. 23 demonstrates yet an additional step in removing
material from the disc.
[0037] FIG. 24 is a sectioned view of, an introducer with a trocar
present therein.
[0038] FIG. 25 is a sectioned view of the introducer with a
retractor therein.
[0039] FIG. 26 is an oblique partial view of a mammalian spine.
[0040] FIG. 27 is an oblique partial view of the mammalian spine
with a retractor in position.
[0041] FIG. 28 is a sectioned view of a sheath.
[0042] FIG. 29 is a sectioned view of a sheath and introducer with
a cutter, fiber optic source and lavage and suction in place.
[0043] FIG. 30 is plan view of a mammalian intervertebral disc
showing a portion of the disc evacuated according to the method of
the invention.
[0044] FIG. 31 shows placement of a support member within the
intervertebral disc.
[0045] FIG. 32 shows a progressive step of the disc being evacuated
according to the method of the invention.
[0046] FIG. 33 shows an additional support being positioned within
the disc.
[0047] FIG. 34 shows an additional progressive step of the disc
being evacuated according to the method of the invention.
[0048] FIG. 35 shows an additional support being positioned within
the disc.
[0049] FIG. 36 shows an additional progressive step of the disc
being evacuated according to the method of the invention.
[0050] FIG. 37 shows an additional progressive step of the disc
being evacuated according to the method of the invention.
DESCRIPTION OF PREFERRED EMBODIMENTS
[0051] Turning now to the drawing figures, FIG. 1 shows a partial
view of a mammalian spine, and more particularly, a human spine 2.
FIG. 2 is a sectioned view taken essentially along line 2-2 of FIG.
1, and shows an annular wall of a disc 4 of a human spine. The
inner annular wall is rough, or jagged, due to trauma, aging and/or
disease. Treatment of the portion of the disc labeled 6 is
indicated due to its condition. Advancement of a catheter into the
disc, and around the wall of the disc to the area to be treated is
difficult, since the tip of the catheter is likely to engage the
rough, jagged inner annular wall. The catheter is preferred to be
laid against the portion of the disc intended to be treated,
minimizing the course of the catheter within the disc, yet assuring
good contact of the catheter with the portion of the disc to be
treated. The angle of entry into the disc should be maximized to
accommodate a spectrum of operative conditions and needle
placements. The portion of the disc requiring treatment as
contemplated in this embodiment is postero-lateral (one side or
both), plus or minus a portion of the posterior wall. The route to
the interior of the disc must be straight. For humans, the distance
from the outer layer of skin to interior of the disc is
approximately 12 to 30 centimeters, depending upon the size of the
individual upon which the process is performed.
[0052] FIG. 3 shows the primary elements of the apparatus of the
present invention. A stylet 8 is inserted into an introducer needle
10. A lumen in the form of a sheath 12 is subsequently inserted
into the introducer needle, and a catheter 14 having a preformed S
shape is advanced through the sheath. The lumen acts as a guide
through which the S-shaped tool such as a catheter, is transported.
The guide may take other forms that will assist transportation of
the tool into the disc, such as a track or a wire that the tool
engages. In one embodiment, the guide is part of the introducer
needle, such as a lumen therein. The introducer needle is preferred
to be straight for ease of placement and due to the distance from
the skin to the interior of the disc. The introducer will generally
have a length in excess of 10 centimeters.
[0053] The stylet and introducer needle form a passage into the
disc through the posterior wall of the disc on the side opposite
that requiring treatment. The stylet is intended to keep the tissue
from accumulating within the advancing introducer needle.
[0054] The introducer needle is advanced under fluoroscopic
guidance lateral to the superior articular process. The annulus is
punctured and the introducer needle may be advanced initially
approximately one-third to one-half of the distance of the disc, as
can be judged by operators skilled in performing such
procedures.
[0055] FIG. 4 shows the introducer needle with stylet in position.
The sharp point of the stylet is driven through the wall of the
disc, along with the introducer needle. The stylet is then removed.
FIG. 5.
[0056] After the stylet and introducer needle pierce the annular
wall of the disc and access the interior of the disc, the stylet is
removed and is replaced with a lumen, which may be a sheath. A
pre-formed, S-shaped catheter or other tool having memory retention
properties is contained within the straight sheath. The straight
sheath is inserted through the introducer needle for introduction
into the disc. The catheter is straightened by the pressure from
the walls of the sheath, but the catheter regains its S-shape as it
exits the sheath. As shown in the drawings, the S-shape comprises
two separate and distinct arcs.
[0057] The sheath locks into place at the external end of the
introducer needle. When locked into place, the catheter sheath will
protrude from the tip of the introducer needle. The sheath remains
well contained within the disc nucleus and not in the proximity of
the opposing annular wall but may be advanced or retracted as
necessary for catheter positioning.
[0058] The sheath is preferred to be made of nonconductive material
having thermal insulative properties sufficient to avoid undesired
heating of tissues and structures outside of the disc, even if the
heating portion of the catheter comes into close proximity or even
contact with this sheath. The sheath may be straight, or slightly
curved, and capable of advancing through the introducer needle once
the stylet is removed. It has sufficient rigidity to maintain a
portion of the catheter in a straight position while that portion
of the catheter is in the sheath. The sheath is capable of
externally locking at an upper portion into the introducer needle
at the hub.
[0059] The non-conductive catheter sheath ensures that no
inadvertent heating of the introducer needle occurs. Heating may
cause significant unwanted damage to skin, subcutaneous tissue,
fat, muscle, and even nerve.
[0060] The sheath is inserted into the lumen of the introducer
needle, while the introducer needle remains in position within the
disc as shown in FIG. 5. In FIG. 6, the catheter is advanced
through the sheath. As the S-shaped catheter exits the sheath
within the interior of the disc, the catheter, due to memory
retention properties, and with no pressure applied, assumes its
S-shape, with two separate and distinct arcs, as shown in FIG. 6.
In FIG. 7, the catheter continues to advance and contacts the
lateral inner annular wall of the side on which the postero-lateral
wall is to be treated. Catheter advancement may be fluoroscopically
monitored.
[0061] FIG. 8 demonstrates the introducer needle being retracted
from the disc as the catheter is advanced. This combination of
movements causes the catheter to move toward the postero-lateral
and posterior wall which is the intended side of treatment. As
shown, the introducer needle and sheath are retracted until the
catheter is in position against the site to be treated. Positioning
of the sheath and the catheter may be monitored
fluoroscopically.
[0062] As shown in FIG. 9, the introducer needle is retracted until
the catheter rests against the lateral posterior wall to be
treated. The lateral posterior wall to be treated is opposite the
side of the posterior wall that the introducer needle has
penetrated. Heat or radio frequency can be applied to the disc wall
by means of the catheter. Other therapeutic procedures may be
applied by use of an appropriate catheter. The catheter may then be
retracted, and the introducer needle is retracted from the disc as
shown in FIG. 10. Either the tip of this catheter can be
differentially heated to seal the needle entry defect, or the S
shaped catheter is removed and replaced with a straight catheter
with a heating element at the tip. Heating of the tip as the
needle-sheath-catheter complex is withdrawn seals the entry defect.
Alternately, a catheter with a portal at the tip to inject a
sealant of this entry defect may be used.
[0063] For needle positions between the extremes of acute and
obtuse, the length of sheath versus disbursed catheter will
determine the position at which the catheter tip will come into
contact with the opposite lateral wall. Recognition of the goal of
having the catheter contact the mid portion of the lateral wall of
the side to be treated, and monitoring progress under fluoroscopy
will facilitate ideal catheter placement.
[0064] The portion of the catheter intended to be within the disc
has an S shape when no material pressure or force is applied to the
catheter. The catheter may be formed of nitinol, which is
sufficiently flexible to be advanced through a straight lumen or
sheath, but will regain the preformed arcuate or S-shape when
present within the interior of the disc. The catheter should also
be sufficiently flexible to conform to the shape of the disc wall,
such as the posterior wall of the inner disc, when positioned
against the wall. FIG. 9.
[0065] The S-shaped catheter allows the physician to treat the
posterior wall, and particularly the lateral posterior wall, of a
defective disc without the necessity of first contacting the
anterior wall with the catheter. The device and process prevent the
end or tip of the catheter from catching or hanging against the
rough interior annular wall, which may have many crevices that make
it difficult to advance the catheter along the wall. The S-shaped
catheter allows the catheter to be introduced into the interior of
the disc, and then positioned by manipulation of the introducer
needle and catheter, without subjecting the catheter to being
snagged by defects in the disc. The S shape facilitates good
contact of the catheter with the postero-lateral segment of the
disc even if the angle of the needle entry is suboptimal.
Additionally, the S shape retards the catheter traversing through
any large segment of the interior of the disc which is typically
filled with debris. This minimizes "shoveling" of the debris toward
the segment of the inner annular wall to be treated. One skilled in
the art will recognize that since the S-shape of the tool
facilitates reaching the lateral wall portions and surfaces of the
disc, which are the most difficult portions to reach, that the tool
of this shape will reach remaining portions and surfaces of the
disc.
[0066] Catheters may contain heating segments of various lengths. A
final heating element, which is contained in each of these types of
catheters, may be present directly at the tip, and is used for the
spot sealing on exit from the inner annular wall. An additional
embodiment has a straight catheter with a heating element at the
tip.
[0067] On withdrawal of the catheter, the end or tip of the
catheter straightens as it is exiting the annular wall. Spot
heating at this position by tip 16 seals the defect that was
created by the introducer and catheter.
[0068] FIG. 11 demonstrates an acceptable range of angles of needle
insertion 18 when driving the introducer needle into the disc. The
acceptable range of angles is within about 70 degrees, but is not
less than forty five degrees. Due to the S shaped configuration of
the catheter, a precise entry of the introducer needle is not
required.
[0069] As shown in FIG. 12, acceptable results are achieved with
the S-shaped catheter used according to the novel method, even
though the angle of needle insertion varies from that shown in FIG.
9. Likewise, the angle of needle insertion may be varied as shown
in FIG. 13. The introducer needle may be withdrawn from the
position shown in FIG. 13 to the interior, posterior annular wall,
and S-shaped catheter is capable of being positioned against the
lateral posterior wall of the disc by the method stated above.
[0070] The catheter may provide heat or radio frequency for the
purpose of treatment of the disc. Other therapeutic applications
may be used with the device and method. Further, a catheter 20 may
have multiple orifices for the purpose of delivering materials such
as adhesives, sealants or fillers into the disc. FIG. 14. A
substance 22 may be injected through the catheter to the affected
site to seal chemically, or otherwise, as opposed to thermally,
defects including fissures and tears in the annular wall. Pressure
manometery or fibro-optical viewing are also possible uses of this
catheter system.
[0071] FIG. 15 shows a second embodiment of the device, wherein the
sheath has ports 32, 34 formed therein. The stylet is shown in
position in the introducer needle of this embodiment. The stylet
and introducer needle are used to access the interior annulus of
the disc and shown in FIG. 17.
[0072] After entry into the disc, the stylet is withdrawn. The
ports of the sheath may be used to insert materials into the disc,
or remove materials from the disc. A vacuum may be applied to the
ports for the purpose of removal of material.
[0073] FIG. 18 shows a flexible deformable tip of the sheath.
Deformation of the tip, which may be visualized fluoroscopically,
defines hitting the inner annular wall. In one embodiment, 0.5
centimeters is sufficient protrusion of the sheath, such that it
can be observed to bend when it contacts opposite inner annular
wall. The bending of the tip of the sheath defines the limit of the
inner annular wall immediately across from the entrance of the
introducer needle complex into the disc. The limit of the inner
annular wall opposite to the needle insertion may be defined when
fluoroscopically viewed.
[0074] As shown in FIG. 16, a rotary cutter 36 is contained within
the sheath. The rotary cutter is used to cut away material as the
introducer needle is withdrawn. FIG. 20. Alternately, another type
of cutter may be used.
[0075] When the introducer needle, sheath and cutter complex are in
the nucleus, the tip of the flexible sheath is advanced by external
manipulation such that it protrudes from the introducer needle. The
threaded probe protrudes from the sheath, such as by 2-3 mm. The
rotating threaded probe is activated to rotate within the inner
annular wall. The initial "pass" of the rotating threaded probe is
accomplished by withdrawing the introducer needle/sheath/probe
linearly back to the position where the introducer/sheath tip is at
the level of the opening into the inner annular wall as previously
defined. The complex is then advanced back to its position at the
opposite inner annular wall as previously defined fluoroscopically.
The sheath/probe is kept in its current position while the
introducer needle is withdrawn a pre-defined distance, such as 5 mm
in one embodiment. The complex is again withdrawn with probe
rotating. An additional amount of material is removed, similarly to
mowing a lawn. If an additional amount of material is present
between the first and second probe withdrawals, the amount of
insertional needle withdrawal can be modified to be less than, for
example, 5 mm. In successive fashion, the complex is advanced, the
introducer needle 40 withdrawn, the rotation of the treaded probe
is started, the sheath/probe, and then the introducer segment, is
withdrawn until the final sheath/probe withdrawal is accomplished
with the introducer needle tip at the level of the insertional
inner annular wall. Since the sheath is S shaped, short lengths of
sheath protruded from the needle will be arcuate. Incrementally
longer segments of exposed sheath assume varying degrees of the S
shape. This process very thoroughly evacuates the approximately
half of the nucleus that is initially addressed. At this point, the
sheath/probe is withdrawn into the introducer needle. The
sheath/probe is rotated substantially 180 degrees within the
introducer. The process is then repeated in the same fashion on the
opposite half of the nucleus. Infusion of a substance, which could
be normal saline, via a side portal 32 into the sheath, alternating
with suction at portal 34, may be performed at intervals to
facilitate removal of the nuclear contents.
[0076] The sheath has a pre-formed S shape, and a memory for the S
shape. Accordingly, as the rotary cutter is extended from the
introducer needle, the sheath will continue to curve slightly,
which allows material 42 which is adjacent to the cut taken in FIG.
20 to be removed. FIG. 21. As the rotary cutter cuts material away,
lavage/suction are applied through the ports 34 of the introducer
needle. One port allows for infusion of a substance (which may be
normal saline) into one port. The other port is for suction or
other form of removal of material including debris from the disc.
By increasing the length of the S shaped sheath from the needle 40,
additional passes each take material from the disc, as the cutter
is further extended from the sheath. FIG. 22A demonstrates the
cutter after the cutter has made six passes, and is beginning a
seventh pass. In each pass, the arcuate shape of the sheath as it
is extended which allows for progressively removing from the
interior of the disc. Shorter segments of the sheath exposed from
the introducer needle have an arcuate shape allowing for an
infinite number of paths throughout the disc enabling the removal
of nuclear material if needed.
[0077] After the material is removed from one side of the disc, the
cutter is retracted into the needle. The cutter and/or the sheath
are rotated 180 degrees, so that the S shaped cutter is present on
the opposite side of the disc. FIG. 22B. The sheath containing the
cutter is extended from the introducer needle on each subsequent
pass as needed, until material is removed as desired from the disc
as shown in FIG. 23.
[0078] FIG. 24 shows a trocar 50 that is a present within an
introducer 52. The trocar may be a relatively large stylet. FIG. 25
shows a retractor 54 that is present within the introducer. The
retractor manipulates the nerve root 56.
[0079] FIG. 26 shows a vertebra 58 of a mammalian spine, an
additional vertebra 60 of a mammalian spine, with an intervertebral
disc 62 between the vertebrae. Also shown are a pedicle 64, a
superior articular facet 68 and an inferior articular facet 66. The
nerve root 56 is shown as traversing the intervertebral disc. As
shown, the position of the nerve root interferes with access to the
intervertebral disc. FIG. 26 is an oblique view demonstrating what
is typically visualized fluoroscopically for intradiscal
procedures, except for the nerve root, which does not visualize
under fluoroscopy, but whose position is known to an experienced
operator.
[0080] The trocar is used to pierce and penetrate skin and other
tissue. Upon reaching the nerve root, the trocar is removed and the
retractor is inserted. The retractor is used to lift the nerve root
over the introducer needle, so that the nerve root is out of the
way, and does not interfere with access to the intervertebral disc.
FIG. 27.
[0081] Once the retractor has repositioned the nerve root over the
introducer, the retractor may be removed from the introducer, and
the trocar reinserted into the introducer. With the nerve root
positioned over the introducer, the nerve root will not be damaged
as the trocar and introducer are inserted into the intervertebral
disc. The trocar pierces the intervertebral disc for access to the
disc with the introducer.
[0082] FIG. 28 demonstrates a cross section of a sheath 70 that is
used to evacuate a defective disc according to the method
described. The sheath has three lumens in the embodiment shown. A
first lumen 72 is used as a conduit for a fiber optic cable. A
second lumen 74 is provided through which a cutter is delivered to
the work site within the intervertebral disc. The cutter could be a
laser cutter, or a mechanical cutter, such as a rotary cutter.
[0083] A third lumen 76 is relatively larger, and provides a
conduit for lavage and suction. Saline or other materials may be
introduced to the work site in the disc through the lumen. Tissue
that is removed, along with attendant blood and other materials,
may be suctioned and evacuated through lumen 76.
[0084] FIG. 29 shows the fiber optic source 78, cutter 80 and the
conduit for lavage and suction 82.
[0085] The introducer penetrates the wall of the disc as described
above. The introducer is shown as having penetrated the lateral
posterior wall of the disc 84 in FIG. 30. The sheath is positioned
within the disc through the introducer. The sheath is initially
positioned so that its forward end extends only slightly beyond the
end of the introducer needle. The cutter, the fiber optic and the
lavage and suction are actuated, and the entire assembly, along
with the introducer needle, are pushed to the opposite wall 86 of
the disc, which in this case, is the lateral anterior portion of
the disc so that the pulposa of the disc and the disc wall itself
are removed, as shown in FIG. 30. Since the materially extended
sheath has an S-shape when no pressure is applied to the sheath,
there will be a slight curvature of the sheath as it marginally
extends from the introducer needle. Accordingly, the cut as shown
in FIG. 30 is somewhat conical in shape, rather than being
straight, due to the arcuate shape of the sheath when the sheath is
advanced slightly from the introducer.
[0086] The evacuation progresses outwardly. As the intervertebral
disc is removed, support must be provided for the adjoining the
vertebrae. FIG. 31 shows the cutter removed from the sheath, and a
support member or strut 88 placed in position using insertion or
placement tool. The support member or strut may be capable of
inflation using, for example, saline. Accordingly, the support
member or strut may be a balloon or bladder.
[0087] The sheath is progressively extended, and progressive cuts
are made using the introducer to traverse generally linearly in and
out of the disc. As shown in FIG. 32, progressive cuts are made
until the disc and associated pulposa 90 are substantially
completely removed from one side of the introducer needle. The
cutter may be removed from the sheath as required, and the
placement tool inserted for placement of the support members or
struts within the intervertebral disc.
[0088] After one side of the disc is substantially removed, the
sheath, and/or the introducer needle and sheath, are rotated 180
degrees. FIG. 34. The cutter is in position in the sheath.
Additional progressive passes are made by steering and advancing
the introducer and sheath, individually, or as a unit within the
disc, and with the cutter in place. The sheath is progressively
extended on each pass, so that the portion of the disc that is
further away from the introducer is removed with each progressive
pass.
[0089] The S-shape of the sheath permits the material of the disc
to be removed which is offset to each side of the introducer, even
though the introducer is advanced and retracted on what is
generally a straight line dictated by the void formed in the disc
through which the introducer passes. The S-shape of the sheath
allows the cutter to reach progressively laterally as the sheath is
progressively extended from the introducer. The sheath of this
embodiment, and the catheter shown in FIG. 3 through FIG. 14, and
the sheath shown in FIG. 22A through FIG. 23, each have an S-shape
when no material pressure is applied to the catheter or sheath. The
catheter or sheath in each embodiment of the invention shown herein
has a memory property which returns the catheter or sheath to an
S-shape when no material pressure is applied to the catheter or
sheath. However, when the catheter or sheath is present within the
introducer, or in the case of the catheter, within the sheath for
the catheter, the S shaped element is reformed to be straight, but
regains it S shape as it exits the straight lumen. The sheath is
preferred to be straight, and in some embodiments, rigid when used
with an S-shaped catheter or tool having shape memory.
[0090] Continuing with the process of this preferred embodiment as
shown in the drawings, FIG. 36 demonstrates the final cutting away
of the disc by slight protrusion of the sheath from the introducer.
FIG. 37 uses the cutter with the cutter even more slightly
extending from the needle to remove the disc. However, in practice,
it may be necessary to remove the entire intervertebral disc. It
may be desirable to leave some of the intervertebral disc in place
as a support, as long as the targeted defective portion of the
intervertebral disc is removed by the method described herein.
[0091] The procedures and processes described herein may be, and
are preferred to be, performed percutaneously. The procedures and
processes may be performed using stab incision or small incision
techniques, or techniques wherein an incision of about 2.5
centimeters or less is used to provide access for the introducer,
the sheath and/or the tool.
* * * * *