U.S. patent application number 12/565673 was filed with the patent office on 2010-01-21 for restless leg syndrome treatment.
This patent application is currently assigned to CoolTouch Incorporated. Invention is credited to Clint Hayes, David R. Hennings, Don Johnson, John R. Kingsley.
Application Number | 20100016846 12/565673 |
Document ID | / |
Family ID | 46329327 |
Filed Date | 2010-01-21 |
United States Patent
Application |
20100016846 |
Kind Code |
A1 |
Hennings; David R. ; et
al. |
January 21, 2010 |
Restless Leg Syndrome Treatment
Abstract
The present invention describes a method of treating restless
leg syndrome by eliminating venous reflux in an underlying vein.
The malfunctioning vein can be removed or ablated by inserting a
catheter into the vein that transmits sufficient energy to
coagulate or ablate the lining of the vein causing it to
permanently close, eliminating the source of venous reflux and the
symptom of restless leg syndrome.
Inventors: |
Hennings; David R.;
(Roseville, CA) ; Johnson; Don; (Roseville,
CA) ; Hayes; Clint; (Roseville, CA) ;
Kingsley; John R.; (Roseville, CA) |
Correspondence
Address: |
RAY K. SHAHANI, ESQ., ATTORNEY AT LAW
TWIN OAKS OFFICE PLAZA, 477 NORTH NINTH AVENUE, SUITE 112
SAN MATEO
CA
94402-1858
US
|
Assignee: |
CoolTouch Incorporated
Roseville
CA
|
Family ID: |
46329327 |
Appl. No.: |
12/565673 |
Filed: |
September 23, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11855762 |
Sep 14, 2007 |
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12565673 |
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10982504 |
Nov 4, 2004 |
7524316 |
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11855762 |
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PCT/US03/35178 |
Oct 30, 2003 |
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10982504 |
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10699212 |
Oct 30, 2003 |
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11855762 |
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60825687 |
Sep 14, 2006 |
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60422566 |
Oct 31, 2002 |
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60422566 |
Oct 31, 2002 |
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Current U.S.
Class: |
606/15 |
Current CPC
Class: |
A61B 2018/00005
20130101; A61B 18/24 20130101; A61B 2090/036 20160201; A61B
2017/00084 20130101; A61B 2018/00196 20130101; A61B 2018/2261
20130101 |
Class at
Publication: |
606/15 |
International
Class: |
A61B 18/22 20060101
A61B018/22 |
Claims
1. A system for endovenous treatment of restless leg syndrome
comprising the following: A laser having a wavelength between about
1.2 and about 2.7 um; A fiber optic laser delivery device having a
proximal end and a distal end, for delivery of laser energy from
the distal end of the fiber optic laser delivery device to the
inside wall of a vein; and A pullback device which retracts the
fiber optic laser delivery device through the vein at a rate of
between about 0.1 mm/sec and about 10.0 mm/sec while simultaneously
delivering laser energy therefrom, wherein collagen in the vessel
wall can be heated and shrunk in the absence of blood.
2. The system of claim 1 in which the pullback device retracts the
fiber optic laser delivery device through the vein at a rate of
between about 0.5 mm/sec and about 5.0 mm/sec.
3. The system of claim 1 further comprising an introducer catheter,
wherein the fiber optic laser delivery device can be introduced to
the vein.
4. The system of claim 3 in which the introducer catheter comprises
an elongated lumen portion having a proximal end and a distal end,
wherein the fiber optic laser delivery device is introduced to the
introducer catheter through the proximal end and is introduced to
the vein through the distal end.
5. The system of claim 1 where a laser energy emitting tip is
prevented from making vein wall contact through the use of a
coating around the tip of the fiber that creates a space between
the emitting tip of the fiber and the vein wall.
6. The system of claim 1 in which a pulsed laser is used, the pulse
width between 1 and 5000 microseconds.
7. The system of claim 1 in which a pulsed laser is used, the pulse
width between 20 and 500 microseconds.
Description
RELATED APPLICATIONS
[0001] This Application is a Divisional of related pending U.S.
patent application Ser. No. 11/855,762 filed Sep. 14, 2007 entitled
RESTLESS LEG SYNDROME TREATMENT, Attorney Docket No. CTC-701, which
is the non-provisional application of and related to U.S.
Provisional Patent Application Ser. No. 60/825,687 filed Sep. 14,
2006 entitled RESTLESS LEG SYNDROME TREATMENT, Attorney Docket No.
CTC-701-P, which also is a continuation-in-part of and claims
benefits of U.S. patent application Ser. No. 10/982,504, filed on
Nov. 4, 2004, and titled ENDOVENOUS CLOSURE OF VARICOSE VEINS WITH
MID INFRARED LASER, Attorney Docket No. 15487.4001/NSL-502, which
application is a continuation-in-part of and claims the benefit of
International Application Number PCT/US2003/035178, filed under the
Patent Cooperation Treaty on Oct. 30, 2003, Attorney Docket No.
NSL-501-PCT, titled "ENDOVENOUS CLOSURE OF VARICOSE VEINS WITH MID
INFRARED LASER", which application claims the benefit of U.S.
Provisional Patent Application Ser. No. 60/422,566 filed Oct. 31,
2002, entitled "ENDOVENOUS CLOSURE OF VARICOSE VEINS WITH MID
INFRARED LASER", Attorney Docket No. NSL-501-P, each of which
applications is incorporated herein by reference in its entirety
and claims any and all benefits to which it is entitled therefrom.
This Application is also a continuation-in-part of U.S. application
Ser. No. 10/699,212 filed Oct. 30, 2003, Attorney Docket No.
NSL-501, entitled "ENDOVENOUS CLOSURE OF VARICOSE VEINS WITH MID
INFRARED LASER", which application claims the benefit of U.S.
Provisional Patent Application Ser. No. 60/422,566 filed Oct. 31,
2002, entitled "ENDOVENOUS CLOSURE OF VARICOSE VEINS WITH MID
INFRARED LASER", Attorney Docket No. NSL-501-P, each of which
applications is incorporated herein by reference in its
entirety.
FIELD OF THE INVENTION
[0002] This invention relates to methods and apparatus for treating
restless leg syndrome (RLS). Specifically the method includes
eliminating venous reflux in a vein in the leg by closing it with
energy derived from a radio frequency generator, using a foam
sclerosant, and using an electrical resistance circuit or a
laser.
BACKGROUND OF THE INVENTION
[0003] RLS is a poorly understood disorder in which patients
experience compelling urges to move the legs usually accompanied by
intense, unpleasant sensations in their legs. RLS affects 5-15% of
the American and European populations. RLS affects the general
population with a mean age at onset of 27.2 years. Onset of RLS is
often before age 20 in 38.3% of patients. Women are twice as likely
to be affected. The earliest description of an RLS case was by
English physician and anatomist Sir Thomas Willis in 1672. RLS
lingered in anonymity until 1944, when Swedish neurologist Karl
Ekbom first described the salient features. In 1945 he coined the
phrase "restless legs". The addition of the word "syndrome"
designates this malady as a condition defined by clinical symptoms
rather than by any specific pathological process.
[0004] Most patients find they cannot describe the nature of their
sensations. It is frequently unrecognized or misdiagnosed and
therefore widely undertreated. Dr. Ekbom felt that "this is
evidently due to the fact that the sensations do not resemble any
known phenomenon that can be used as a comparison." They are
variably described as heebie-jeebies, antsy, Jimmy legs, or as
creeping-crawling, pulling, drawing, boring, wormy, etc. The
sensations are painful in about 30% of patients. Patients
experience intense unpleasant sensations deep in the legs that are
accompanied by an irresistible urge to move the affected limbs. The
sensations are usually located in the calf area, but may be felt
anywhere from the ankles to the thighs. The arms are rarely
involved.
[0005] There is a wide variation in severity with some patients
experiencing only occasional mild symptoms, while others struggle
with disabling episodes on a nightly basis. Symptoms of RLS are
worse in the evening and during periods of relaxation or decreased
activity, especially while lying down or reclining. Patients are
often completely asymptomatic in the morning. The reason for this
is unknown. The desire to relieve the symptoms can lead to a
compulsion involving excessive limb movements. The sensations and
the compulsion to relieve them frequently become terribly
distressing. As RLS symptoms are stronger at bedtime, sleep-onset
insomnia is common. RLS sufferers often find they cannot sleep
until the early morning hours. Patients with severe RLS experience
nightly attacks that lead to chronic sleep-deprivation with its
accompanying psychological and cognitive deficits.
[0006] Investigators have made great strides in the understanding
and treatment of RLS over the last two decades, to the nightly
relief of millions of victims. The etiology of RLS remains elusive,
however, and a final common pathway has yet to be described.
According to Dr M. J. Thorpy, primary RLS "may represent a
heterogeneous group of disorders because no single pathophysiologic
mechanism explains all the clinical features exhibited."
[0007] There are no classic physical findings, no conclusive blood
assays, and no standard radiological or sleep studies to diagnose
RLS. Because there is no known biomarker, the diagnosis of RLS can
only be made based on clinical history. In an attempt to more
clearly define RLS, the IRLSSG developed RLS diagnostic criteria in
1995. An IRLSSG consensus panel at the National Institutes of
Health (NIH) modified these criteria to their present form in 2003.
These four criteria are necessary and sufficient for the diagnosis
of RLS. They include: 1) Urges to move the limbs with or without
unpleasant sensations, 2) worsening of symptoms at rest, 3)
improvement of symptoms with movement, and 4) worsening of symptoms
at night. The IRLS questionnaire (FIG. 1) was developed by the
IRLSSG and validated in 2003 as a consistent, reliable tool to
objectively measure RLS severity.
[0008] RLS is divided into primary (idiopathic) and secondary
causes. Primary RLS is felt to be the most common form and is
suspected to be a sensorimotor abnormality associated with central
nervous system dysfunction involving abnormal brain iron metabolism
and irregularity of central dopaminergic neurotransmitter pathways.
Primary RLS likely represents a heterogenous group because no
single pathophysiologic mechanism explains all the clinical
features exhibited. Secondary RLS occurs in such disparate
conditions as back pain, iron deficiency, renal failure, pregnancy,
neuropathy, and venous disease. Various medications are known to
precipitate RLS attacks. The fact that RLS is a "mixed bag"
diagnosis has complicated research, confounded investigators, and
frustrated clinicians; in that various medications work in only a
percentage of affected patients. Current treatment therefore
focuses on nightly management of symptoms rather than on cure.
[0009] In 1995, Dr. A. H. Kanter's groundbreaking study suggested
that sclerotherapy in patients with varicose veins and RLS is 98%
effective in initial relief of RLS. This is the first article to
describe operative treatment of RLS. Dr Kanter concluded that all
RLS patients with varicose veins should be considered for
phlebological evaluation and possible treatment before being
consigned to chronic drug therapy.
[0010] Secondary RLS is known to occur in and is secondary to such
disparate conditions as iron deficiency, renal failure, pregnancy,
neuropathy, and venous insufficiency. Various medications are known
to exacerbate existing RLS, even precipitate RLS, and other causes
are likely.
[0011] Because RLS is a "mixed bag" diagnosis, research
investigators have been confounded when treatments only work on a
portion of the test subjects. Treatment of the secondary causes of
RLS can frequently cure patients of this distressing malady.
Because venous insufficiency is a secondary cause, treatment of
this cause may cure the patient of RLS.
[0012] Venous insufficiency is quite common, affecting 10-15% of
adult men and 20-25% of adult women. Duplex ultrasound studies
reveal that saphenous vein reflux is the most common form of venous
insufficiency and is the underlying condition in most patients
suffering with varicose veins. Sclerotherapy in patients with
varicose veins and RLS has been shown to be 98% effective in
initial relief of RLS with recurrence rate of 8% and 28% at one and
two years, respectively. Sclerotherapy is not a very effective
treatment for varicose veins. While effective for tiny surface
veins, the injection of liquid sclerosant into the large veins
responsible for venous insufficiency has a low success rate. This
method requires multiple injections, can be very painful, and the
veins often reopen in a few years requiring, continual treatments.
Most RLS patients are not willing to undergo this therapy. Although
prior art consists of drug therapy and occasionally the use of
compression stockings, surgery in the form of vein stripping has
also not been considered a treatment for this condition because of
the significant morbidity associated with the procedure. This
invention discloses the use of a new minimally invasive treatment
for venous insufficiency that is benign enough to be considered as
a treatment and a cure for RLS with a significantly improved
benefit to cost ratio.
[0013] Varicose veins have been treated in a similar manner except
that the clinical symptoms of varicose veins are much more evident.
Bulging veins, ulcers, pain and leg tiredness are all symptoms of
varicose vein disease. This invention also relates to otherwise
healthy legs that do not necessarily show these symptoms but rather
an early stage of venous disease that causes RLS without bulging
and painful varicose veins.
[0014] This connection between venous insufficiency and restless
leg syndrome has been noted in the literature but the root cause of
the disease and the connections to the venous system is not
obvious. It was only through anecdotal comments by patients who had
restless leg syndrome and were also successfully treated for
varicose veins that the connection became clear. The restless leg
symptoms disappeared after treatment for varicose Veins. This
invention takes this one step farther and claims that restless legs
can be successfully treated even without the symptoms of varicose
veins by eliminating venous reflux in a segment adjacent to the
twitching or skin movement.
[0015] US Pub No. US20030176822A1, published Sep. 18, 2003 to
Morganlander discloses a method of treating restless leg syndrome,
the method comprising the steps of eliminating reflux from an
underlying vein by applying pressure to the leg of the patient.
However, it does not teach or anticipate a method of treating
restless leg syndrome comprising the step of eliminating reflux
from an underlying vein by closing the underlying leg vein
permanently as described in present invention.
[0016] U.S. Pat. No. 6,797,259, issued Sep. 28, 2004 to Rabinowitz
et al. also teaches a method and device to "for delivery of muscle
relaxants through an inhalation route which are typically used for
the treatment musculoskeletal pain or restless leg syndrome."
However, the "applying energy, such as microwave or laser light"
described in Rabinowitz et al. is for "the heating of the muscle
relaxant compositions" in an inhalation device, not "to the
treatment site". Applicant submits that Rabinowitz does not teach
or anticipate a method of treating restless leg syndrome comprising
the step of eliminating reflux from an underlying vein by closing
the underlying leg vein permanently.
ADVANTAGES AND SUMMARY OF THE INVENTION
[0017] This invention describes a method to cure Restless Legs
Syndrome (RLS) in a percentage of patients without the expense and
pain associated with surgery and with far better short and long
term results than the use of liquid sclerotherapy. This new method
promises to become the treatment of choice to enable RLS patients
to be taken off of debilitating and expensive drug therapy that
only treats the symptoms of RLS.
[0018] It is an advantage of the present invention to provide a
method of treating restless leg syndrome in which the method
comprises the step of eliminating reflux from an underlying vein.
It is a further advantage of the present invention to provide said
method in which the step of eliminating reflux from an underlying
vein comprises closing an underlying leg vein with energy to
eliminate venous reflux. In an embodiment of the present invention,
the energy is of the type selected from the group consisting of
infrared, ultraviolet, visible, radio frequency, ultrasound and
laser. In an embodiment of the present invention, the step of
eliminating reflux from an underlying vein comprises using an
endovenous catheter to deliver energy to a segment of incompetent
vein. In an embodiment of the present invention, step of
eliminating reflux from an underlying vein comprises uses foam
sclerotherapy.
[0019] It is an advantage of the present invention to provide a
method of treating restless leg syndrome wherein the step of using
laser energy to eliminate reflux in a short segment of vein around
the symptomatic region.
[0020] It is yet another advantage of the present invention to
provide a method of treating restless leg syndrome comprising the
step of eliminating venous reflux in an underlying vein in the
absence of vein varicosities, ulcers or other visible symptoms.
[0021] It is yet another advantage of the present invention to
provide an endovenous method of treating restless leg syndrome
comprising the step of using a laser having a wavelength between
about 1.2 and about 2.7 um to heat and shrink collagen in a vessel
wall, and in which the step of delivering the laser energy with a
fiber optic laser delivery device. An embodiment of the invention
comprises the steps of inserting a fiber optic laser delivery
device into the vein and using a pullback device to retract the
fiber optic laser delivery device through the vein at a rate of
between about 0.1 mm/sec and about 10.0 mm/sec while simultaneously
delivering laser energy therefrom. In an embodiment of the
invention, the fiber optic laser delivery device is retracted at a
rate of between about 0.5 mm/sec and about 5.0 mm/sec. In another
embodiment of the invention, the pullback device is left off
initially to let heat build up at the start therefore enabling a
better closure of the vessel. It is an advantage to remove blood
from the vein prior to treatment with laser energy. It is yet a
further advantage to introduce the fiber optic laser delivery
device to the vein through an introducer catheter. In an embodiment
of the present invention, a pulsed laser is used, the pulse width
between 1 and 5000 microseconds.
[0022] Further details, objects and advantages of the present
invention will be come apparent through the following descriptions,
and will be included and incorporated herein.
BRIEF DESCRIPTION OF THE DRAWINGS
[0023] FIG. 1 is a representative schematic block diagram of an
embodiment of an apparatus 100 of the present invention for
performing of a varicose vein closure procedure of the present
invention.
[0024] FIG. 2A is a representative view of varicosed veins 200 to
be treated according to the method and apparatus of the present
invention.
[0025] FIG. 2B is a representative view of the GSV 202 to be
treated according to the method and apparatus of the present
invention.
[0026] FIG. 3A is a representative view showing the beginning of
the introducer or dilator 300 for percutaneous access according to
the method and apparatus of the present invention.
[0027] FIG. 3B is a representative view showing the use of the
introducer or dilator 300 with the laser fiber 306 passing through
the lumen 302 of the dilator 300 and into the GSV 202 according to
the method and apparatus of the present invention.
[0028] FIG. 4 is a representative view of the use of an ultrasound
device 400 according to the method and apparatus of the present
invention.
[0029] FIG. 5 is a representative view of the non-contact thermal
sensor 600 and the cooling system 602 of the method and apparatus
of the present invention.
[0030] FIG. 6 shows curves for absorption coefficients of melanin,
hemoglobin and water as a function of wavelength according to the
method and apparatus of the present invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0031] The description that follows is presented to enable one
skilled in the art to make and use the present invention, and is
provided in the context of a particular application and its
requirements. Various modifications to the disclosed embodiments
will be apparent to those skilled in the art, and the general
principals discussed below may be applied to other embodiments and
applications without departing from the scope and spirit of the
invention. Therefore, the invention is not intended to be limited
to the embodiments disclosed, but the invention is to be given the
largest possible scope which is consistent with the principals and
features described herein.
[0032] It will be understood that in the event parts of different
embodiments have similar functions or uses, they may have been
given similar or identical reference numerals and descriptions. It
will be understood that such duplication of reference numerals is
intended solely for efficiency and ease of understanding the
present invention, and are not to be construed as limiting in any
way, or as implying that the various embodiments themselves are
identical. [0033] 1. Perform and document a thorough exam of all
veins contributing to vascular insufficiency and reflux. [0034] 2.
Obtain percutaneous access of the vessel being treated using a
Seldinger Technique. The length and size access devices will vary
depending on the length and size of vein being treated and the
fiber selected. [0035] 3. Advance catheter [0036] Advance the
catheter through the introducer sheath until it is approximately
1-2 cm below the saphenofemoral junction (SFJ) or the
saphenopopliteal junction (SPJ) or at the appropriate distance
based on the junction or vein being treated. [0037] Confirm
position of the catheter tip with ultrasound. [0038] Visualize the
aiming beam through the patient's skin (the room lights may need to
be darkened at this point for adequate visualization). [0039] 4.
Once the catheter is in the desired position, the following methods
should be used to reduce vein size: [0040] Position patient in
20.degree.-30.degree. Trendelenburg or equivalent. It will be
understood that this typically refers to a supine position with the
patient inclined at an angle of 0-45 degrees, so that the pelvis is
higher than the head, used during and after operations in the
pelvis or for shock. [0041] Elevate the extremity being treated
[0042] Use a syringe to suction vein contents through the access
device port [0043] Use a compression wrap [0044] Manual compression
[0045] 5. Inject local anesthesia around the vein being treated
[0046] Using ultrasound, observe infiltration of tumescent
anesthesia solution around the vein. [0047] The vein should be
completely surrounded with at least 10 mm of fluid to provide
thermal protection for the surrounding tissue. [0048] 6. Remove or
pull out any introducer sheath, leaving just the proximal tip just
at the skin edge of the access site [0049] Removal of the sheath
will prevent the catheter from entering the sheath during the
automatic pull-back. [0050] Reconfirm tip position once the sheath
has been pulled out. [0051] 7. Begin treatment and observe tissue
response under ultrasound observation. If the desired tissue effect
in the vein is not seen, increase wattage. Indications of adequate
tissue response include: [0052] Slowing or stopping of forward
movement of flow [0053] Thickening of the vein wall [0054]
Contraction of the vein [0055] Decrease in size of the vein lumen
[0056] 8. Continue to observe the aiming beam through the skin and
the tissue effect in the vein with the ultrasound. Place fingers on
either side of the catheter at the exit point from the skin to
verify movement and to support the fiber as it is being pulled out.
[0057] 9. Following the treatment, observe the appearance of the
vein with the ultrasound: [0058] Vein appears more dense and
thickened (more echogenic) [0059] Vein is less compressible with
pressure from the ultrasound probe [0060] Vein lumen is noticeably
smaller in size [0061] Vein does not demonstrate spontaneous flow
[0062] 10. Apply dressings at the completion of the procedure:
[0063] Steri-Strips.RTM. [0064] Absorbent dressing over access site
[0065] 3-inch self-adherent tape wrap [0066] 30-40 mm Hg
compression hosiery should be placed over dressings with the
patient lying down.
Devices and Equipment:
[0067] As described above, the tissue may be heated or treated with
any operative heating device. These include, but are not limited to
the followings: a laser diode or other laser source, electrical
current, radiofrequency waves, microwaves, ultrasound or other
source of electromagnetic energy which penetrates into regions of
tissue, by conduction or convection as with bubble generation in
blood, contact device, active or passive heating means, etc., thus
preferentially heating a region of tissue without excessive or
otherwise undesirable heating of or effect on surrounding
tissue.
[0068] Examination of veins and diagnosis of RLS is taught by Allen
R P, Abetz L, Washburn T, Early C J. THE IMPACT OF RESTLESS LEGS
SYNDROME (RLS) ON SLEEP AND COGNITIVE FUNCTION. Eur J Neurol. 2002;
9 (suppl2):50, which is hereby incorporated herein by reference in
its entirety, without limitations.
[0069] Use of ultrasound for intravenous catheter or other
structure visualization, catheter positioning and treatment device,
structure and function is further taught by U.S. Pat. No. 6,024,703
filed May 7, 1997 entitled ULTRASOUND DEVICE FOR AXIAL RANGING,
which is hereby incorporated herein by reference in its entirety,
without limitations.
[0070] Percutaneous access of vessels methods, device, structure
and function is further taught by pending U.S. patent application
Ser. No. 10/699,212 filed Oct. 30, 2003 entitled ENDOVENOUS CLOSURE
OF VARICOSE VEINS WITH MID INFRARED LASER (Attorney Docket No.
NSL-501), which is hereby incorporated herein by reference in its
entirety, without limitations.
[0071] Automatic, motorized or other equivalent pull-back method,
device, structure and function is further taught by pending U.S.
patent application Ser. No. 10/699,212 filed Oct. 30, 2003 entitled
ENDOVENOUS CLOSURE OF VARICOSE VEINS WITH MID INFRARED LASER
(Attorney Docket No. NSL-501), which is hereby incorporated herein
by reference in its entirety, without limitations.
[0072] FIG. 1 is a representative schematic block diagram of the
apparatus 100 of the present invention for performing the varicose
vein closure procedure of the present invention. As shown, the
system 100 of the present invention includes a laser console 102, a
motorized, fiber optic catheter "pull-back" machine 104, a fiber
optic catheter or other laser delivery device 106 to deliver laser
energy into the patient's vein, a sterile field 108 and a
controller 110.
[0073] FIG. 2A is a representative view of varicosed veins 200 to
be treated according to the method and apparatus of the present
invention. FIG. 2B is a representative view of the GSV 202 to be
treated according to the method and apparatus of the present
invention. FIG. 3A is a representative view showing the beginning
of the introducer or dilator 300 for percutaneous access according
to the method and apparatus of the present invention. FIG. 3B is a
representative view showing the use of the introducer or dilator
300 with the laser fiber 306 passing through the lumen 302 of the
dilator 300 and into the GSV 202 according to the method and
apparatus of the present invention.
[0074] FIG. 4 is a representative view of the use of an ultrasound
device 400 according to A method and apparatus of the present
invention. FIG. 5 is a representative view of a physician 500
performing manual compression of tissue near the tip 308 of the
fiber 306 according to the method and apparatus of the present
invention. As described herein, it will be understood that the
means for applying mechanical compression of the tissue near the
tip 308 of the fiber includes manual compression, mechanical clamps
or straps, chemical or other drug-induced swelling, etc.
[0075] FIG. 5 is a representative view of the non-contact thermal
sensor 600 and the cooling system 602 of the method and apparatus
of the present invention. Non-contact thermal sensors 600 as well
as contact devices, including RTDs, are well known in the art. It
will be understood that the cooling device 602 can be any suitable,
controlled device which allows a predetermined amount of cryogenic
fluid to be dispensed from an on-board fluid reservoir or from an
external/line source. In a preferred embodiment, the device 602 is
computer controlled, to provide spurts or squirts of cryogenic
fluid at a predetermined rate or for a predetermined duration. The
cryogenic fluid is dispensed onto the surface of the skin 604 in an
area adjacent the fluid dispensing nozzle 606, and the non-contact
thermal sensor 600 determines the temperature of the skin in the
same area 604 or in an area 608 distal from the area being cooled
604. The present invention, this application and any issued patent
based hereon incorporates by reference the following issued patents
with regards surface cooling methods and apparatus utilized in the
present invention: U.S. patent application Ser. No. 08/692,929
filed Jul. 30, 1996, now U.S. Pat. No. 5,820,626. U.S. patent
application Ser. No. 938,923 filed Sep. 26, 1997, now U.S. Pat. No.
5,976,123. U.S. patent application Ser. No. 10/185,490 filed Nov.
3, 1998, now U.S. Pat. No. 6,413,253. U.S. patent application Ser.
No. 09/364,275 filed Jul. 29, 1999, now U.S. Pat. No.
6,451,007.
[0076] FIG. 6 shows curves for absorption coefficients of melanin,
hemoglobin and water as a function of wavelength according to the
method and apparatus of the present invention. It will be observed
in FIG. 6 that the region between about 550 nm to about 1060 nm
shows high hemoglobin absorption and low water absorption, as is
well known in the prior art technology. It will further be observed
that the region between about 1200 nm to about 1800 nm shows low
hemoglobin and higher water absorption, which is a key to the
present invention.
Clinical Results:
[0077] The following is a description of a study undertaken with
the financial support of the American College of Phlebology
BSN-JOBST Phlebology 2006 Research Grant.
[0078] Our results were presented at the 20th Annual Congress of
the American College of Phlebology at Sawgrass Marriott Resort and
Beach Club, Ponte Vedra Beach, Fla., Nov. 9-12, 2006.
Objective Summary:
[0079] Venous disease was proposed as a cause of Restless Legs
Syndrome (RLS) by Dr. Karl A. Ekbom in 1944, but has since remained
largely unexplored. This study examines the effect of Endovenous
Laser Ablation (ELA) in patients with concurrent RLS and
duplex-proven Superficial Venous Insufficiency (SVI) The aim of
this study is to determine what effect ELA has in patients with RLS
and SVI.
Methods Summary:
[0080] Thirty-five patients with moderate to very severe RLS (as
defined by the 2003 NIH RLS criteria) and duplex-proven SVI
completed an International RLS rating scale questionnaire (IRLS)
and underwent standard duplex examination to objectively measure
the baseline severity of their conditions. They were separated into
non-operative and operative cohorts. The operative cohort underwent
ELA of refluxing superficial axial veins using the CoolTouch CTEV
1320 nm laser and ultrasound-guided sclerotherapy of the associated
varicose veins with foamed sodium tetradecyl sulfate (STS). All
patients then completed a follow-up IRLS questionnaire. Baseline
and follow-up IRLS scores were compared.
Results Summary:
[0081] Operative correction of the SVI decreased the mean IRLS
score by 21.4 points from 26.9 to 5.5, corresponding to an average
80% improvement in symptoms. Eighty-nine percent of patients
enjoyed a decrease in their score of .gtoreq.15 points. Fifty-three
percent of patients had a follow-up score of .ltoreq.5, indicating
their symptoms had been largely alleviated, and 31% had a follow-up
score of zero, indicating complete relief of RLS symptoms.
Conclusions and Recommendations Summary:
[0082] ELA of refluxing axial veins with the CTEV 1320 nm laser and
foamed STS sclerotherapy of associated varicosities alleviates RLS
symptoms in patients with SVI and moderate to very severe RLS.
Additionally, SVI should be ruled out in all patients with RLS
before initiation or continuation of drug therapy.
Patients and Study Design:
[0083] We screened 89 patients with complaints of restlessness in
their legs. The diagnosis of RLS was determined using the 2003 NIH
criteria. All patients who met the criteria for RLS were
interviewed to confirm the diagnosis of RLS and to exclude
conditions that mimic RLS (such as positional discomfort,
neuropathy, night cramps, etc.). They then completed an initial
IRLS questionnaire to determine the baseline severity of their
disease. Those patients with an IRLS score of 15 or greater
(corresponding with moderate to very severe RLS) underwent a
screening duplex ultrasound. Patients found to have greater than
500 milliseconds of reflux in the great saphenous vein (GSV)
underwent a complete duplex evaluation of the deep, superficial,
and perforator systems. All reflux was mapped for appropriate
treatment. Thirty-five patients met the criteria and were accepted
into the study.
[0084] Sixteen patients were assigned to the non-operative cohort,
19 to the operative cohort. In the non-operative cohort 6.3% of
patients were male and 93.7% were female. The mean age was 58.8,
and the average weight 180.2 pounds. In the operative cohort, 31.6%
of patients were male and 68.4% were female. The mean age was 49.4,
and the average weight was 202.5 pounds. One patient withdrew from
each cohort for unrelated medical reasons.
[0085] Most RLS patients take medication nightly in order to get
some sleep. We felt it important for this study to be applicable to
the broader population. We therefore did not exclude patients who
were taking RLS medications. In order to stabilize RLS medication
as a variable, we did ask patients not to add any or discontinue
medications known to affect RLS symptoms during the study
period.
Intervention:
[0086] Patients were assigned to either the non-operative or
operative cohort. Non-operative patients completed a follow-up
questionnaire six weeks after the initial questionnaire. This
yielded objective measurements of the severity of the baseline and
final RLS symptoms in the non-operative cohort.
[0087] The operative patients underwent ELA of all refluxing axial
veins using the Cool-Touch 1320 nm laser at settings of 50 Hz and 7
Watts. The pullback device was set on 0.5 mm/sec for the first 10
cm, then 1.0 mm/sec for the remainder of the vein. These laser
settings applied 140 Joules/cm to the first 10 cm of vein, and 70
Joules/cm to the remainder of the vein (this rather high fluence
was utilized to ensure 100% ablation of all treated veins).
Varicose veins and refluxing perforator veins were treated with
ultrasound-guided sclerotherapy using 1.0% STS foam. A 6-inch ACE
wrap was applied immediately post-operatively and continued for 48
hours, then replaced with 20-30 mm/hg compression stockings for two
weeks. Compression was then removed. Operative patients underwent a
post-operative duplex examination 2-3 days after the procedure, and
again six weeks later. They completed a final IRLS questionnaire at
the 6-week follow-up appointment. The baseline and final IRLS
scores of both groups were then compared.
Study Design and Statistical Analysis:
[0088] The 35 patients who met the inclusion criteria were enrolled
into this prospective, randomized, unblinded, parallel two-group,
pre-post-test study. This study design involved outcome variables
measured on binomial and continuous scales. For the continuous
outcome variables (i.e., IRLS questionnaire), one-way analysis of
variance with two distinct levels of the intervention was
performed. Moreover, since unequal sample sizes were anticipated
and observations were repeated over time, Bonferroni procedures
were appropriate to control for experimentwise, multi-comparison
error. Matched-pairs analysis was used to test the null hypothesis
of zero change from IRLS baseline score.
[0089] When analyzing binomial variables (i.e., RLS Symptoms
Alleviated, yes or no), Chi-square and likelihood ratio statistics
were computed to test the null hypothesis of no association between
the intervention groups and the response variable(s). In addition,
since single-group pre- and post-test comparisons were performed
and the assumption of independent samples was not met, McNemar's
test for matched pairs was appropriate. Exact tests were used and
exact probabilities were computed where appropriate.
[0090] All statistical analysis activities were performed using SAS
Statistical Software, Version 9.1.3, SAS Institute, Inc., North
Carolina, USA. The procedures used are PROC ANOVA, PROC GLM, and
PROC FREQ.
Results:
[0091] Duplex evaluation performed 6 weeks postoperatively revealed
that 100% of the treated veins were successfully ablated. Transient
postoperative discomfort in the region of the treated veins was
frequently reported. Most patients required only PRN Ibuprofen,
foregoing the prescribed hydrocodone. All patients had mild
bruising at the access sites. There were no major side effects or
complications.
[0092] When comparing mean baseline IRLS scores for the
non-operative and operative cohorts, 26.8 vs. 26.9 respectively,
the difference was not found to be statistically significant
(p=0.971). Consequently, one could assume homogeneity in RLS
symptoms and severity across treatment groups prior to
intervention. At the final evaluation, the mean IRLS score in the
non-operative cohort was actually found to be slightly elevated
(28.4) in contrast to their baseline mean score. The mean IRLS
score in the operative cohort decreased by 21.4 points to 5.5. This
represents a drop in symptom severity of 80%. The matched-pairs
analysis was statistically significant (p<0.0001) indicating
that the change from baseline in IRLS score for the operative group
was significantly greater than the change from baseline in IRLS
score for the non-operative group.
[0093] Eighty-nine percent of operative patients enjoyed a decrease
in their IRLS score of 15 points or more. Seventy-nine percent of
patients improved to "mild" disease (final score .ltoreq.10).
Ninety-five percent of patients improved to "mild" or "moderate"
disease (final score .ltoreq.20). Fifty-three percent of patients
had a final score .ltoreq.5, indicating their RLS symptoms had been
largely alleviated. Thirty-one percent of patients had a final
score of zero, indicating complete relief of RLS symptoms.
Discussion:
[0094] In Dr. K. A. Ekbom's original 1944 article, he presented 8
patients with what he called asthenia crurum paraesthetica
"irritable legs". He described the symptoms RLS and said that, in
most patients, objective signs were lacking. One (12.5%) of these
patients, however, was noted to have varicose veins. Dr. Ekbom went
on to say that all patients had palpable dorsalis pedis pulses, yet
he concluded "It is possible that the condition is due to a
functional vascular disorder." He suspected venous congestion and
an accumulation of metabolites to be a cause of RLS. Our study
demonstrates that treating the underlying venous disease can
relieve the RLS symptoms.
[0095] Venous insufficiency is an impedance of venous flow back to
the heart. It is usually caused by venous reflux secondary to
valvular failure and can occur in the deep, superficial, or
perforator veins. Venous insufficiency results in high venous
pressures that are transmitted to tributary veins, venules,
capillaries and interstitial tissues drained by the diseased vein.
It affects 10-15% of men and 20-25% of women. SVI is much more
common than deep venous insufficiency.
[0096] According to the Starling concept, most of the fluid forced
out of the capillary bed at the arterial end is normally returned
into the lumen at the venous end. In tissues affected by venous
hypertension, this delicate balance is disrupted. The high
hydrostatic pressure in the venules and capillaries causes a net
increase in the fluid remaining in the interstitial space. This
increased interstitial fluid volume overwhelms the lymphatic
capacity, resulting in edema formation. As long as the leg is
dependant, the interstitial fluid continues to accumulate, until
the tissue pressure rises to a point at which the Starling
equilibrium is restored. Considerable edema can accumulate before
this point of equilibrium is reached. Upon elevation of the leg
(such as when the patient is lying down or reclining), the venous
pressures diminish and the lymphatics can drain the engorged
interstitium.
[0097] The circadian ebb and flow of edema fluid seen in venous
insufficiency closely parallels the circadian timing of RLS
symptoms. This is more than mere coincidence. We know that the
daily accumulation of soft tissue edema creates unpleasant
sensations in the legs such as heaviness, fullness, achiness, etc.
The nightly receding of that edema fluid somehow causes the
"indescribable" sensations that typically plague RLS patients. This
would explain why the typical RLS symptoms occur when the patient
is reclining and at night, as the elevation mobilizes edema from
the legs, and why symptoms seem to wane in the early morning hours
(the edema has largely resolved by that time. The restless leg
movement is a subconscious activation of the musculovenous pump,
stretching of afflicted muscles and tendons, or a distracter to
mask the tormenting sensations.
[0098] This discovery is supported by the fact that 26% of women
are affected by RLS during their pregnancy. Pregnancy has been
shown to exacerbate both RLS and edema independently. Strong
correlation is noted with the third trimester of pregnancy (when
the pregnancy-associated edema is at its peak) and tends to
disappear with delivery (when the pregnancy-associated edema has
receded).
[0099] Similar findings are seen in hemodialysis patients. RLS
affects 20-80% of this population. Despite extensive research of
various clinical and biochemical parameters, the cause of RLS in
this population remains unknown. It has been shown that increasing
dialysis from 3 days a week to 5 days a week (but not changing
total number of hours per week) relieves the RLS symptoms. RLS
symptoms disappear in hemodialysis patients who receive a kidney
transplant. Frequent dialysis dampens and renal transplant
eliminates the huge volume swings normally seen in hemodialysis
patients, thus impacting their RLS symptoms.
[0100] Primary RLS is generally felt to be a condition in which an
abnormal nervous system is reacting inappropriately to relatively
normal legs. In RLS patients with venous disease, it appears that
RLS is due to a relatively normal nervous system reacting
appropriately to abnormal legs.
Strengths and Limitations of the Study:
[0101] We employed the NIH criteria to make the diagnosis of RLS
and the IRLS questionnaire to grade the severity of symptoms. These
tools are widely utilized in current RLS research. They made
possible accurate comparisons between operative and control groups.
This allowed us to gather statistically significant results despite
our small sample size.
[0102] Bias was introduced in this study by including only those
RLS patients with duplex-proven SVI. All RLS patients with normal
venous function were therefore excluded. Bias was also introduced
in the manner in which the patients were assigned to operative vs.
non-operative cohorts. Medicare and third party insurance carriers
require a three to six month trial of "conservative non-operative
measures". Because of time constraints, patients who had not met
these criteria before presenting to our vein center were
automatically placed in the non-operative cohort. Patients who had
met these mandates were placed in the operative cohort. Further
study will explore the connections between RLS, venous
insufficiency, and lower extremity edema.
Conclusions:
[0103] Our results demonstrate that ELA of refluxing axial veins
and sclerotherapy of associated varicosities alleviates or relieves
RLS symptoms in patients with moderate to very severe RLS and SVI.
All RLS patients should be properly evaluated for venous
insufficiency by a technician familiar with techniques to detect
venous reflux before initiation or continuation of drug therapy.
Any RLS patient with venous insufficiency should be referred for
evaluation and treatment by a phlebologist. Following these methods
and procedures, these patients can escape the nightly torment of
chronic RLS.
[0104] U.S. patent application Ser. No. 11/855,762 filed Sep. 14,
2007 entitled RESTLESS LEG SYNDROME TREATMENT, Attorney Docket No.
CTC-701, U.S. Provisional Patent Application Ser. No. 60/825,687
filed Sep. 14, 2006 entitled RESTLESS LEG SYNDROME TREATMENT,
Attorney Docket No. CTC-701-P, U.S. patent application Ser. No.
10/982,504, filed on Nov. 4, 2004 entitled ENDOVENOUS CLOSURE OF
VARICOSE VEINS WITH MID INFRARED LASER, Attorney Docket No.
15487.4001/NSL-502, PCT Application Number PCT/US2003/035178, filed
under the Patent Cooperation Treaty on Oct. 30, 2003, Attorney
Docket No. NSL-501-PCT, entitled ENDOVENOUS CLOSURE OF VARICOSE
VEINS WITH MID INFRARED LASER, U.S. Provisional Patent Application
Ser. No. 60/422,566 filed Oct. 31, 2002, entitled "ENDOVENOUS
CLOSURE OF VARICOSE VEINS WITH MID INFRARED LASER", Attorney Docket
No. NSL-501-P, U.S. application Ser. No. 10/699,212 filed Oct. 30,
2003, Attorney Docket No. NSL-501, entitled ENDOVENOUS CLOSURE OF
VARICOSE VEINS WITH MID INFRARED LASER, U.S. Provisional Patent
Application Ser. No. 60/422,566 filed Oct. 31, 2002, entitled
ENDOVENOUS CLOSURE OF VARICOSE VEINS WITH MID INFRARED LASER,
Attorney Docket No. NSL-501-P, are all incorporated herein by
reference in their entireties.
[0105] Unless defined otherwise, all technical and scientific terms
used herein have the same meaning as commonly understood by one of
ordinary skill in the art to which the present invention belongs.
Although any methods and materials similar or equivalent to those
described can be used in the practice or testing of the present
invention, one methods and materials are now described. All
publications and patent documents referenced in the present
invention are incorporated herein by reference.
[0106] While the principles of the invention have been made clear
in illustrative embodiments, there will be immediately obvious to
those skilled in the art many modifications of structure,
arrangement, proportions, the elements, materials, and components
used in the practice of the invention, and otherwise, which are
particularly adapted to specific environments and operative
requirements without departing from those principles. The appended
claims are intended to cover and embrace any and all such
modifications, with the limits only of the true purview, spirit and
scope of the invention.
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