U.S. patent application number 12/877885 was filed with the patent office on 2011-09-08 for preparation for endovenous laser ablation.
This patent application is currently assigned to COOLTOUCH INCORPORATED. Invention is credited to Mitchel P. Goldman, David R. Hennings, Don V. Johnson, Eric B. Taylor, Robert A. Weiss.
Application Number | 20110218525 12/877885 |
Document ID | / |
Family ID | 46326666 |
Filed Date | 2011-09-08 |
United States Patent
Application |
20110218525 |
Kind Code |
A1 |
Hennings; David R. ; et
al. |
September 8, 2011 |
Preparation For Endovenous Laser Ablation
Abstract
Improved systems and methods for removing blood from a blood
vessel in preparation for endovenous laser ablation are described.
The improved methods include one or more of: placing the patient in
the Trendelenburg position, applying external compression around
the vein, massaging the vein, cooling the vein externally,
encouraging spasming of the vein, and removing blood with a suction
device.
Inventors: |
Hennings; David R.;
(Roseville, CA) ; Goldman; Mitchel P.; (San Diego,
CA) ; Weiss; Robert A.; (Hunt Valley, MD) ;
Taylor; Eric B.; (Roseville, CA) ; Johnson; Don
V.; (Roseville, CA) |
Assignee: |
COOLTOUCH INCORPORATED
Roseville
CA
|
Family ID: |
46326666 |
Appl. No.: |
12/877885 |
Filed: |
September 8, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11562944 |
Nov 22, 2006 |
7921854 |
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12877885 |
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10699212 |
Oct 30, 2003 |
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11562944 |
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11562944 |
Nov 22, 2006 |
7921854 |
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10699212 |
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10982504 |
Nov 4, 2004 |
7524316 |
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11562944 |
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PCT/US2003/035178 |
Oct 30, 2003 |
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10982504 |
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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 18/24 20130101;
A61B 2090/036 20160201; A61B 2018/2261 20130101; A61F 7/10
20130101; A61B 2017/00084 20130101; A61B 2018/00005 20130101; A61B
2018/00196 20130101; A61F 2007/101 20130101 |
Class at
Publication: |
606/15 |
International
Class: |
A61B 18/22 20060101
A61B018/22 |
Claims
1. An endovenous system for treating a varicose vein of a patient,
the system comprising a laser having a wavelength between about 1.2
and 2.5 um to heat and shrink collagen, a mechanism for
exsanguinating the varicosed vein, and an endovenous fiber optic
laser delivery device for endovenously transmitting the laser
energy directly into the varicosed vein.
2. The system of claim 1, wherein the mechanism for exsanguinating
the varicosed vein is apparatus for maintaining the patient in the
Trendelenburg position.
3. The system of claim 1, wherein the mechanism for exsanguinating
the varicosed vein is a flexible bandage suitable for wrapping the
leg of the patient, thereby forcing blood out of the vein.
4. The system of claim 1, wherein the mechanism for exsanguinating
the varicosed vein is a massage device, wherein when the massage
device is applied externally to the leg of the patient, blood will
be exsanguinated from the vein.
5. The system of claim 1, wherein the mechanism for exsanguinating
the varicosed vein is a cooling device for cooling the leg of a
patient, thereby causing the vein to constrict.
6. The system of claim 1, wherein an ultrasound handpiece is used
to compress the vein and visually determine if any blood is left in
the vein.
7. The system of claim 1, further comprising means to cause the
vein to spasm, thereby causing constriction of the vein.
8. The system of claim 7, wherein the vein spasm is caused by
vibrating or moving a catheter when it is inside the vein.
9. The system of claim 7, wherein a vasoconstricting drug is
applied near the vein, thereby causing the vein to constrict.
10. The system of claim 9, wherein the vasoconstricting drug
comprises epinephrine.
11. The system of claim 1, wherein a suction device is used to
remove blood from the vein.
12. The system of claim 3, wherein said flexible bandage is removed
after the blood is removed from the vein, after tumescent
anesthesia is injected, and prior to an endovenous laser ablation
being performed on said vein.
13. The system of claim 1, wherein a femoral block is injected into
the leg of the patient.
14. An endovenous system of treating a varicose vein of a patient,
the system comprising using a laser having a wavelength between
about 1.2 and 2.5 um to heat and shrink collagen in a varicosed
vessel, the laser energy transmitted via fiber optic laser delivery
device directly into the varicosed vein from which blood has been
sufficiently drained.
15. The system of claim 14, wherein blood is removed from the vein
by placing the patient in the Trendelenburg position.
16. The system of claim 14, wherein a leg of the patient is wrapped
in a flexible bandage, thereby forcing blood out of the vein.
17. The system of claim 14, wherein the vein is massaged externally
by hand to exsanguinate blood from the vein.
18. The system of claim 14, wherein the leg is cooled, thereby
causing the vein to constrict.
19. The system of claim 14, wherein an ultrasound handpiece is used
to compress the vein and visually determine if any blood is left in
the vein.
20. The system of claim 14, further comprising mechanism for
causing the vain to spasm, thereby causing constriction of the
vein.
21. The system of claim 20, wherein the vein spasm is caused by
vibrating or moving a catheter when it is inside the vein.
22. The system of claim 14, wherein a vasoconstricting drug is
applied near the vein, thereby causing the vein to constrict.
23. The system of claim 22, wherein said vasoconstricting drug
comprises epinephrine.
24. The system of claim 14, wherein a suction device is used to
remove blood from the vein.
25. The system of claim 16, wherein said flexible bandage is
removed after the blood is removed from the vein, after tumescent
anesthesia is injected, and prior to an endovenous laser ablation
being performed on said vein.
26. The system of claim 14, wherein a femoral block is injected
into the leg of the patient.
Description
RELATED APPLICATION
[0001] This Application is continuation of pending U.S. application
Ser. No. 11/562,944 filed Nov. 22, 2006, Attorney Docket No.
NSL-503, entitled "PREPARATION FOR ENDOVENUOUS LASER ABLATION",
which application is continuation-in-part of pending 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.
The said U.S. application Ser. No. 11/562,944 filed Nov. 22, 2006,
Attorney Docket No. NSL-503, entitled "PREPARATION FOR ENDOVENUOUS
LASER ABLATION" is also continuation-in-part 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, now U.S. Pat. No.
7,524,316, which application is 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, entitled "ENDOVENOUS CLOSURE OF
VARICOSE VEINS WITH MID INFRARED LASER", designating the United
States of America, and 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.
FIELD OF THE INVENTION
[0002] The present invention relates generally laser assisted
method and apparatus for treatment of varicose veins and, more
particularly, to improved methods for preparing a patient to
undergo endovenous laser ablation procedures.
BACKGROUND OF THE INVENTION
[0003] Most prior techniques to treat varicose veins have attempted
to heat the vessel by targeting the hemoglobin in the blood and
then having the heat transfer to the vessel wall. Lasers emitting
wavelengths of 500 to 1100 nm have been used for this purpose from
both inside the vessel and through the skin Attempts have been made
to optimize the laser energy absorption by utilizing local
absorption peaks of hemoglobin at 810, 940, 980 and 1064 nm. RF
technology has been used to try to heat the vessel wall directly
but this technique requires expensive and complicated catheters to
deliver electrical energy in direct contact with the vessel wall.
Other lasers at 810 nm and 1.06 um have been used in attempts to
penetrate the skin and heat the vessel but they also have the
disadvantage of substantial hemoglobin absorption which limits the
efficiency of heat transfer to the vessel wall, or in the cases
where the vessel is drained of blood prior to treatment of
excessive transmission through the wall and damage to surrounding
tissue. All of these prior techniques result in poor efficiency in
heating the collagen in the wall and destroying the endothelial
cells.
[0004] For example, Navarro et al., U.S. Pat. No. 6,398,777, issued
Jun. 4, 2002, teaches that it is necessary to have at least some
blood in the vein to absorb Diode laser radiation to perform
endovenous ablation. More recently, Navarro teaches to remove a
significant amount of blood but to leave a layer in the vein to act
as an absorbing chromophore for the laser. These lasers in fact
will not perform laser ablation of the vein walls with a completely
blood free vein.
[0005] Goldman et al., in U.S. Pat. No. 6,752,803, issued Jun. 22,
2004, teach the removal of blood with the use of tumescent
anesthesia to compress the vein prior to laser treatment. This
method has the disadvantage of not completely removing blood from
the vessel. It is generally accepted within the art that the most
compression that tumescent anesthesia can accomplish is to bring
the vessel to about 5 mm in diameter. At this size, a significant
amount of blood can remain in the vessel. In fact, since tumescent
anesthesia will only compress the vein to a controlled size, the
use of tumescent anesthesia has proven to be an excellent way to
leave a precisely controlled amount of blood in the vein to act as
an absorbing chromophore for hemoglobin targeting lasers such as
the 810, 940 and 980 nm diode systems.
[0006] On the other hand, recent attention has been paid to
endovenous laser ablation techniques using lasers operating at
wavelengths that do not require the presence of blood in the vein.
For example, Hennings et al., in U.S. Patent Publication No.
2005/0131400, published on Jun. 16, 2005, teaches that lasers
operating at wavelengths of from about 1200 nm to about 1800 nm
produce laser energy that is more strongly absorbed by the vessel
walls than by the blood, in comparison to the lasers operating at
lower wavelengths. Accordingly, the lasers and laser ablation
techniques described by Hennings will actually operate better when
the vein is drained as far as possible.
[0007] Regardless of the endovenous laser treatment method used,
any blood remaining in the vessel also has the potential of
creating additional problems. For example, depending upon the laser
system components and their operating parameters, the blood that
remains in the vein may coagulate when heated by the laser and
cause thrombosis, non closures, or pain and bruising. In addition,
small pockets of blood act as heat sinks during the laser treatment
and need to be heated to coagulation temperatures in order to
adequately ablate the vein wall. One milliliter of blood can absorb
close to one joule of energy to raise its temperature one degree
Celsius. Since the damage temperature of the vein wall is around 80
degrees C, it could take as much as 50 Joules of energy to raise
this small pocket of blood from 30 deg C. The laser treatment
dosage is typically only 70 to 80 Jules per centimeter of vein
length, so a one milliliter pocket of blood could absorb all of the
energy intended to ablate the vein wall in that area leading to a
section of non closure of the vein.
[0008] Furthermore, if the vein wall is perforated during ablation
with blood present, blood may leak out of the vein causing bruising
and discoloration of the skin post op.
[0009] Still further, during vein ablation, while the vein is
shrinking to complete closure, blood left in the vein is squeezed
out of the vein through the access point requiring sponging and
absorbing pads to clean it up.
[0010] Blood will coagulate at about 80.degree. C. Small pockets of
blood that have coagulated and remain in the vein can prevent the
vein from completely collapsing on itself. This residual thrombus
prevents the opposing coagulated vein walls from touching during
the healing process and prevents them from healing together. This
is a major cause of non closures and failed procedures. Desmyttere
et al. described the increased efficacy of endovenous ablation when
using a 980 nm diode laser, and when the Trendelenburg position is
used to drain the blood prior to treatment. See Jacques Desmyttere
et al., "A 2 years follow-up study of endovenous 980 nm laser
treatment of the great saphenous vein: Role of the blood content in
the GSV," Elsevier, 19 Aug. 2005. They report closure rates of 91%
after 2 years when blood is drained compared to closure of only 74%
when the patient is in the horizontal position.
[0011] Finally, blood that is coagulated can be forced out of the
vein into the remaining venous system and travel through the body
as a deep vein thrombosis (DVT). This is a serious and potentially
life threatening condition.
[0012] For these reasons, and for the reason that the mid infrared
laser does not require a blood chromophore to convert laser energy
into thermal energy, it would be desirable to have a method for
more completely removing blood from the vein prior to endovenous
ablation.
ADVANTAGES AND SUMMARY OF THE INVENTION
[0013] The present invention is directed to devices and methods for
preparing a patient to undergo an endovenous laser ablation
procedure. The subject devices and methods are intended to
facilitate removal of blood from a vein or other vessel undergoing
laser ablation prior to the actual ablation procedure. Removal of
blood has been found to be beneficial to the patient, both in terms
of increasing the efficacy of most laser ablation procedures, and
in terms of increasing the safety of most laser ablation
procedures.
[0014] The preparation method steps including the following: [0015]
placing the patient in the Trendelenburg position, with the
patient's feet elevated above the patient's head, thereby
preventing blood from entering the vein after exsanguination;
[0016] compressing the vein, preferably by applying a flexible
bandage or other flexible wrap to the exterior of the leg of the
patient; [0017] massaging the vein, either manually or with a
suitable electronic medical device; [0018] cooling the vein, using
any suitable cooling device such as an ice pack, ice wrap, or other
external cooling device; [0019] causing the vein to spasm, such as
by injection of a suitable vaso constrictor near the vein; and
[0020] suctioning blood out of the vein, such as by connecting and
operating a suction device to an access port of a sheath contained
within the vein.
[0021] In a preferred embodiment, the patient is first given an
injection of a femoral blocking anesthetic. After the anesthetic is
administered, the venous blood removal procedures (described above)
are implemented. After substantially all of the blood has been
removed from the vein, all compression devices are removed, and
tumescent anesthesia is injected along the vein to serve as a heat
sink. One of any suitable endovenous laser treatment procedures is
then performed.
[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 an illustration of a leg of a patient having
varicosed veins 200 to be treated according to the methods and
apparatus of the present invention.
[0024] FIG. 2 is an illustration of the leg of a patient shown in
FIG. 1, further showing the use of an introducer or dilator 300
with a laser fiber 306 passing through a lumen 302 of the dilator
300 and into the greater saphenous vein 202.
[0025] FIG. 3 is an illustration of the leg of a patient shown in
FIG. 1, with the leg being positioned in the Trendelenburg
position.
[0026] FIG. 4 is an illustration of the leg of a patient shown in
FIG. 3, with a bandage or other wrap applied to the leg.
[0027] FIG. 5 is an illustration of the leg of a patient shown in
FIG. 4 undergoing a manual massage.
[0028] FIG. 6 is an illustration of the leg of a patient shown in
FIG. 4, further including an ice pack for cooling.
[0029] FIG. 7 is an illustration of the leg of a patient shown in
FIG. 4, further illustrating the application by injection of a vaso
constrictor.
[0030] FIG. 8 is an illustration of the leg of a patient shown in
FIG. 2, further illustrating the use of a suction device on a port
of the introducer sheath.
[0031] FIG. 9 is an illustration of the leg of a patient shown in
FIG. 2, further illustrating the use of an ultrasound device.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0032] 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
principles 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 principles and
features described herein.
[0033] 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.
[0034] The methods for preparing a patient to undergo an endovenous
laser ablation procedure are suitable for use with any endovenous
laser ablation procedure, but the subject methods find particular
application with those procedures for which substantially complete
removal of blood from the vein is most beneficial. Several prior
art endovenous laser ablation procedures are described above,
including those taught by Navarro et al. (U.S. Pat. No. 6,398,777)
and those taught by Goldman et al. (U.S. Pat. No. 6,752,803). Most
preferred are the methods taught by Hennings et al. in U.S. Patent
Publication No. 2005/0131400, and those taught by Hennings et al.
in U.S. patent application Ser. No. ______, (Attorney Docket No.
15487.4004), filed on behalf of the same assignee and on the same
date as the present application. Each of the foregoing patents and
publications is hereby incorporated by reference in its
entirety.
[0035] The methods described herein are intended to remove as much
blood as possible from the vein upon which the endovenous laser
ablation procedure is to be applied. To that end, the following
procedures are used.
[0036] Turning first to FIG. 1, a varicosed vein 200 to be
subjected to an endovenous laser ablation procedure is shown in the
leg 201 of the patient. A femoral blocking injection is used to
provide anesthesia during the endovenous ablation. The laser
ablation methods taught by Hennings et al. include use of the 1320
nm Nd:YAG laser, which has been shown to be much less painful than
prior art devices, and which therefore allows the use of a less
invasive single injection to block pain signals traveling along the
femoral nerve instead of injecting large amounts of anesthesia all
along the vein during a comparable tumescent procedure. In the
preferred method, a 2 inch 22 gauge electrical nerve stimulator
needle 500 may be inserted in the groin and the femoral nerve
located with electrical stimulus. When the nerve is located, 10-15
ml of bupivacaine with epinephrine is injected to completely block
sensation of pain from the lower extremities.
[0037] Next, as shown in FIG. 2, access to the vein is performed
prior to draining the vein of blood. Once an access sheath is in
place and the fiber is inserted into the vein, the vein can be
drained without affecting the ability to get the fiber in position.
An introducer sheath or dilator 300 is introduced into the vein by
one of several techniques known to those skilled in the art. A
quartz or sapphire optic fiber 306 is inserted through the lumen
302 of the introducer 300 and into the vein. Alternatively, the
optic fiber 306 may be inserted directly into the vein 200 via a 16
gauge or similar sized needle, or through the vein 200 which has
been externalized through a 2-3 mm incision with a phlebectomy hook
(not shown). The fiber 306 is preferably from about 500 to about
600 .mu.m in diameter, but fibers from about 50 .mu.m or less to
about 1 mm or more may be used. The optic fiber 306 includes an
energy emitting tip 308 through which energy produced by the laser
is emitted.
[0038] Once the access sheath 300 is in place, one or more of the
following steps may be performed to drain the vein of blood. In a
preferred method, all of the steps are performed. However, as
explained more fully below, it is also contemplated that, for a
given patient or a given set of circumstances, only one or any
combination of two or more of these method steps may be performed
in order to sufficiently drain the vein of blood. Although the
steps are preferably performed in the order described below,
alterations of the order of steps are also possible.
[0039] First, as illustrated in FIG. 3, the patient is placed in
Trendelenburg position, in which the patient's feet 203 are
positioned above the body. This position prevents new blood from
entering the vein 202 when the vein is exsanguinated.
[0040] Next, as shown in FIG. 4, the leg is wrapped with a bandage
or flexible wrap 510 to place external compression around the vein
to force blood out. Although a bandage or flexible wrap 510 is
preferred, the compression of the patient's leg may be applied
using any method or device suitable for creating a compression
around the vein that is the subject of the laser treatment
procedure.
[0041] Turning to FIG. 5, the vein is next massaged with hand
pressure 520 to move blood out of the vein. Alternatively, any
suitable mechanical massage device may be used to massage the vein
such that blood is caused to move out of the vein.
[0042] Next, the leg is cooled from the exterior. FIG. 6 shows an
ice pack 530 being applied to the leg. Any suitable mechanism or
device for applying external cooling will be sufficient, including
ice wraps or other external cooling devices.
[0043] Turning to FIG. 7, the next step includes causing the vein
to spasm around the sheath 300. In the preferred method, a small
amount of a vaso constrictor, such as ephinepherine, is injected
via 30 gauge needle syringe 540 near the vein. It is preferable not
to inject more than about 30 to 50 cc of the vaso constrictor. As
the vein spasms around the sheath 300, it causes any remaining
blood contained within the vein to be forced out of the vein.
[0044] Next, a suction device, such as a spring loaded syringe 550,
is attached to an access port 560 in the sheath 300. See FIG. 8.
Alternatively, the suction device may be connected via a separate
port if a small access device is used. Once attached, the suction
device 550 is used to create a vacuum force that acts to suction
out any remaining blood from the vein, completely collapsing the
vein around the sheath 300.
[0045] An ultrasound handpiece 400, which is used for locating the
vein and the fiber 306, can be used to compress the vein and force
blood out. See FIG. 9. This process also provides a real time
visualization of the effectiveness of the drainage process. For
example, when pressure is placed on the skin with the ultrasound
head 400, the vein will change size if it has not been completely
compressed. Accordingly, if the vein is visualized under the
ultrasound and is shown not to change size under compression, this
will serve as an indicator that the vein has been completely
compressed and contains no more blood.
[0046] Once all of the blood is removed, as evidenced by the vein
being completely collapsed under ultrasound examination, then
tumescent anesthesia is injected around the vein to provide a heat
sink Much less tumescent anesthesia is used in the present method
relative to the conventional methods, since the only purpose of the
tumescence is to provide a heat sink around the vein. In
particular, the tumescent anesthesia is not needed for the vein
compression and blood extraction, as taught, for example, in the
Goldman et al. patent. Only 150 to 200 ml of tumescence is needed
and a positive pressure is no longer needed around the vein
compression. The vein has been previously compressed far beyond
what can be done with tumescence alone. Reducing the amount of
tumescence relative to the prior art procedures also reduces the
risk of lidocane reaction in the patient. There is typically a
small but significant risk of lidocane overdose in sensitive
patients. It is generally accepted in the field that using less
than 200 ml of tumescence is adequate for local anesthesia, and as
a heat sink, but is not enough to contribute to vein
compression.
[0047] The endovenous laser ablation procedure can now proceed
according to its normal process. For example, the laser ablation
procedures described in either of the Navarro et al. patent, the
Goldman et al. patent, the Hennings et al. publication, or, most
preferably, the U.S. patent application Ser. No. ______ filed Nov.
22, 2006 (Attorney Docket No. 15487.4004) on behalf of the assignee
of the present application, can be used to ablate the vein. All of
the external compression is removed during the laser ablation.
Since there is now a complete lack of blood in the vein, there is
no need for continued manual compression during the laser
exposure.
[0048] 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, the preferred methods and materials are now described.
All publications and patent documents referenced in the present
invention are incorporated herein by reference.
[0049] 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, 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.
* * * * *