U.S. patent application number 10/196334 was filed with the patent office on 2003-04-17 for lipid pool aspiration arrangement for the treatment of vulnerable atherosclerosis plaque.
Invention is credited to Furnish, Gregory, Phelps, David Y..
Application Number | 20030073975 10/196334 |
Document ID | / |
Family ID | 23996136 |
Filed Date | 2003-04-17 |
United States Patent
Application |
20030073975 |
Kind Code |
A1 |
Phelps, David Y. ; et
al. |
April 17, 2003 |
Lipid pool aspiration arrangement for the treatment of vulnerable
atherosclerosis plaque
Abstract
The present invention comprises a vulnerable plaque treatment
catheter arrangement for the treatment of a lipid pool at a site of
vulnerable plaque within an artery. The catheter arrangement
includes an elongated, hollow, flexible shaft having a proximal end
and a distal end and an elongated, flexible, steerable,
lipid-enterable needle arranged within the shaft. The needle has at
least one lumen therethrough in communication with a treatment
source, to permit the rendering of the lipid pool into an innocuous
entity.
Inventors: |
Phelps, David Y.;
(Anchorcede, KY) ; Furnish, Gregory; (Louisville,
KY) |
Correspondence
Address: |
Donald N. Halgren
35 Central St.
Manchester
MA
01944
US
|
Family ID: |
23996136 |
Appl. No.: |
10/196334 |
Filed: |
July 16, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10196334 |
Jul 16, 2002 |
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09502053 |
Feb 10, 2000 |
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6419659 |
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Current U.S.
Class: |
604/523 |
Current CPC
Class: |
A61B 17/3478 20130101;
A61B 2017/22082 20130101; A61B 2017/22081 20130101 |
Class at
Publication: |
604/523 |
International
Class: |
A61M 025/00 |
Claims
We claim:
1. A vulnerable plaque treatment catheter arrangement for the
treatment of a lipid pool at a site of vulnerable plaque within an
artery, said catheter arrangement comprising: an elongated, hollow,
flexible shaft having a proximal end and a distal end; an
elongated, flexible, lipid-enterable needle arranged within said
shaft, said needle having at least one lumen therethrough in
communication with a treatment source, to permit the rendering of
said lipid pool into an innocuous entity.
2. The vulnerable plaque treatment catheter arrangement as recited
in claim 1, wherein said needle is rotatable within said hollow
shaft, to permit said catheter to be steered.
3. The vulnerable plaque treatment catheter arrangement as recited
in claim 1, wherein said lumen in said needle is connected to a
vacuum source to permit said lipid pool to be suctioned through
said needle by said vacuum source.
4. The vulnerable plaque treatment catheter arrangement as recited
in claim 1, wherein said lumen in said needle is connected to a
pressurized fluid source to permit said lipid pool to be treated by
a liquid or gas medicament.
5. The vulnerable plaque treatment catheter arrangement as recited
in claim 1, wherein said lumen in said needle is connected to an
optical viewing apparatus by an optical fiber to permit said lipid
pool to be monitored by an attendant.
6. The vulnerable plaque treatment catheter arrangement as recited
in claim 1, wherein said needle has a plurality of lumens
therethrough, each in communication with a fluid pressure source
and a suction source respectively to permit a lipid pool to be
suctioned and medicated thereby
7. The vulnerable plaque treatment catheter arrangement as recited
in claim 6, wherein said sheath has a position indicator band
arranged adjacent its distal end to permit locating of said needle
relative to a lipid pool.
8. A method of treating a vulnerable plaque in a coronary artery by
the use of a vulnerable plaque treatment catheter arrangement
comprising the steps of: arranging a movable hollow needle in an
elongated flexible catheter sheath; extending a lumen through said
needle, from a distal tip thereof, to a treatment source proximal
of said catheter sheath; pushing said catheter into an artery to be
treated, so said distal end of said needle reaches a lipid pool in
said artery; piercing a fibrous cap of said lipid pool by said tip
of said needle; and actuating said treatment source to as to effect
treatment of said lipid pool by said catheter arrangement.
9. The method as recited in claim 8, including the step of:
providing a vacuum at said treatment source so as to provide a
suction at said distal tip of said needle in said lipid pool to
draw said lipid therefrom.
10. The method as recited in claim 8, including the step of:
providing a fluid pressure at said treatment source so as to
provide a fluid to be introduced into said lipid pool in said
artery.
11. The method as recited in claim 8, including the step of:
arranging an optical fiber through said lumen so as to permit said
lipid pool to be monitored visually.
12. The method as recited in claim 8, including the step of:
steering said catheter sheath into said artery by articulation of
said needle with respect to said sheath.
13. The method as recited in claim 8, including the steps of:
suctioning said lipid pool by a vacuum source at said proximal end
of said lumen; and introducing a treatment fluid into said lipid
pool from a pressurized treatment fluid source through a second
lumen extending through said needle.
14. The method as recited in claim 13, including the step of:
viewing said lipid pool through an optical fiber arranged through a
third lumen in said needle, said fiber having a proximal end in
communication with a viewing monitor.
15. The method as recited in claim 10, wherein said fluid
introduced into said lipid pool renders said lipid pool inert.
16. The method as recited in claim 10, wherein said fluid
introduced into said lipid pool renders said lipid pool into a
non-thrombogenic semi-solid material.
Description
BACKGROUND OF THE INVENTION
[0001] 1. Field of the Invention
[0002] This invention relates to the treatment of vulnerable
atherosclerosis and more particularly to an arrangement for the
aspiration of a lipid pool within a coronary artery.
[0003] 2. Prior Art
[0004] Atherosclerosis is the leading cause of coronary artery
disease which may otherwise be called heart disease, which is the
leading killer of men and women in the world today. It is
characterized by deposits of fat, fibrin, cellular debris and
calcium on the inside of arterial walls. The early stages of
athersclorotic development is believed to occur as damage to the
endothelial cells and tunica intima of the vessel wall. Once this
damage has begun, the endothelial cells proliferate and attract a
build-up of lipid substances. When these coronary arteries become
blocked, symptoms ranging from angina to heart attacks, may occur.
In a percentage of these cases, the coronary arteries may be
unblocked through a non-invasive technique such as balloon
angioplasty. Some five hundred to six hundred thousand
angioplasties are performed each year within the United States.
Where balloon angioplasty may not be appropriate, a bypass of the
occluded or blocked vessel may be necessary. Identifying an opening
such occlusions is known to give relief to the symtoms of angina,
but it is also known that they do little to prolong life
expectancy. The real killer in this coronary artery disease is
often sudden blockages that are caused not by the slow accumulation
of plaque that gradually block off the arteries, but by a sudden
thrombosis (clotting) of the arteries caused by what are now
referred to as "vulnerable plaque".
[0005] Vulnerable plaques are defined as plaques prone, in the
presence of an appropriate trigger, to events such as ulceration
rupture, erosion or thrombus that can lead to an acute syndrome.
Those events are believed to share three common characteristics, a
large lipid pool, a thin fibrous cap and macrophage
infiltration.
[0006] Current methods of diagnosing arterial disease, using such
as stress tests as angiograms, are inadequate at detecting these
"vulnerable plaques". Therefore, in most instances, this
potentially lethal condition often goes untreated.
[0007] It is an object of the present invention, to provide
treatment options for this particular condition.
[0008] It is a further object of the present invention to provide a
plaque treatment utilizing an improved catheter apparatus to
minimize the accumulation and potential danger of lipids within an
artery.
BRIEF SUMMARY OF THE INVENTION
[0009] The present invention relates to an aspiration/treatment
catheter for the aspiration of a lipid pool within a coronary
artery. The aspiration catheter comprises an elongated, flexible,
polymeric shaft arranged to be pushed within a coronary artery. The
aspiration catheter is hollow and enclosively supports an elongated
needle. The needle is somewhat flexible, and functions as a
guidewire to permit the advancement of the needle and catheter
shaft to the situs of a lipid pool within a coronary artery.
[0010] The needle is flexible and steerable from the proximal end
thereof, which proximal end extends outwardly from the proximal end
of the aspiration catheter. The needle has a plurality of lumens
therein. The first lumen is arranged to provide a suction at the
distalmost tip of the needle, to a controllable vacuum source
arranged in communication with the suction lumen at the proximal
end of the needle. A second lumen is arranged within the steerable
needle to function as a delivery conduit. The delivery conduit is
arranged to bring a fluid or gas to the situs of the lipid pool, to
permit the treatment of that lipid pool with a medicament or fluid
agent.
[0011] A third lumen may be arranged within the steerable needle,
which third lumen is arranged to contain an optic fiber. The optic
fiber extends from the distal end of that steerable needle, within
that needle, and proximally from the proximal and of the needle, to
a monitor or eye piece, to be viewed by the operating physician.
This permits the attending physician to steer the needle as
necessary, and to apply medicaments and suction as needed.
[0012] In one preferred embodiment of the present invention, the
steerable needle is movable longitudinally with respect to the
catheter shaft. The steerable needle is preferably also movable
rotationally with respect to that catheter shaft. The catheter
shaft itself of course is advancable within the artery itself to
the situs of the lipid pool.
[0013] In a further embodiment of the present invention, the
aspiration catheter may have a position-indicating annular-band
adjacent it's distalmost end, to provide the attending physician
with means for determining the location of the catheter by magnetic
or electromagnetic means.
[0014] Thus, in operation of the present aspiration catheter, upon
insertion of that catheter within a coronary artery, and location
of a lipid pool covered by a fibrous cap, as evidenced by the
optical determination thereof, or other sensing means, the needle
is steered and advanced so as to penetrate the fibrous cap and
suction the lipid material from its pool beneath the fibrous cap
and adjacent the artery wall. A treating agent may be injected
within the fibrous cap to facilitate removal of the lipid therefrom
or to promote healing of the artery wall once the aspiration
catheter and steerable needle have been removed therefrom. The
fluid introduced into the lipid pool may be a pharmaceutical agent
to render the lipid non-thrombogenic or to facilitate its
solidification.
[0015] The present invention thus comprises a vulnerable plaque
treatment catheter arrangement for the treatment of a lipid pool at
a site of vulnerable plaque within an artery. The catheter
arrangement comprises an elongated, hollow, flexible shaft having a
proximal end and a distal end; an elongated, flexible,
lipid-enterable needle arranged within the shaft, the needle having
at least one lumen therethrough in communication with a treatment
source, to permit the rendering of the lipid pool into an innocuous
entity. The needle is rotatable within the hollow shaft, to permit
the catheter to be steered. The lumen in the needle may be
connected to a vacuum source to permit the lipid pool to be
suctioned through the needle by said vacuum source. The lumen in
the needle may also be connected to a pressurized fluid source to
permit the lipid pool to be treated by a liquid or gas medicament.
The lumen in the needle is connected to an optical viewing
apparatus by an optical fiber to permit the lipid pool to be
monitored by an attendant. The needle may have a plurality of
lumens therethrough, each in communication with a fluid pressure
source and a suction source respectively to permit a lipid pool to
be suctioned and medicated thereby. The sheath may have a position
indicator band arranged adjacent its distal end to permit locating
of the needle relative to a lipid pool.
[0016] The invention also includes a method of treating a
vulnerable plaque in a coronary artery by the use of a vulnerable
plaque treatment catheter arrangement comprising the steps of:
arranging a movable hollow needle in an elongated flexible catheter
sheath; extending a lumen through the needle, from a distal tip
thereof, to a treatment source proximal of the catheter sheath;
pushing the catheter into an artery to be treated, so the distal
end of the needle reaches a lipid pool in the artery; piercing a
fibrous cap of the lipid pool by the tip of the needle; and
actuating the treatment source to as to effect treatment of the
lipid pool by the catheter arrangement. The method may include the
steps of: providing a vacuum at the treatment source so as to
provide a suction at the distal tip of the needle in the lipid pool
to draw the lipid therefrom; providing a fluid pressure at the
treatment source so as to provide a fluid to be introduced into the
lipid pool in the artery; arranging an optical fiber through the
lumen so as to permit the lipid pool to be monitored visually;
steering the catheter sheath into the artery by articulation of the
needle with respect to the sheath; suctioning the lipid pool by a
vacuum source at the proximal end of the lumen; and introducing a
treatment fluid into the lipid pool from a pressurized treatment
fluid source through a second lumen extending through the needle.
The method includes the steps of: viewing the lipid pool through an
optical fiber arranged through a third lumen in the needle, the
fiber having a proximal end in communication with a viewing
monitor; wherein the fluid introduced into the lipid pool renders
the lipid pool inert or renders the lipid pool into a
non-thrombogenic semi-solid material.
[0017] By such treatment, vulnerable plaques, heretofore defined as
plaques which are prone, in the presence of an appropriate trigger,
to ulceration, rupture, erosion, or thrombus that can lead to an
acute syndrome, may be rendered innocuous.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] The objects and advantages of the present invention will
become more apparent, when viewed in conjunction with the following
drawings in which:
[0019] FIG. 1 is a side elevational view, in partial section, of an
artery and an aspiration catheter constructed according to the
principles of the present invention; and
[0020] FIG. 2 is a side elevational view, in section of a
aspiration catheter in conjunction with a control arrangement for
the flexible needle therewith.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0021] Referring now to the drawings in detail, and particularly to
FIG. 1, there is shown the present invention which comprises an
aspiration and treatment catheter 10 for the aspiration or
medication of a lipid pool "P" within a coronary artery 12. The
aspiration catheter 10 comprises an elongated, flexible, polymeric
shaft 14 arranged to be pushed within a coronary artery. The
aspiration catheter 10 is hollow and enclosively supports an
elongated needle 16. The needle 16 is bendable and flexible, and
functions as a guidewire to permit the advancement of the needle 16
and catheter shaft 14 to the situs of a lipid pool "P" within a
coronary artery 12, and to pierce the fibrous cap "C" to enter the
lipid pool "P".
[0022] The needle 16 is flexible and may be steered from the
proximal end thereof (not shown for clarity of drawing), which
proximal end extends outwardly from the proximal end of the
aspiration catheter 10. The needle 16 has a plurality of lumens
therein. A first or suction lumen 20 is arranged to provide a
suction at the distalmost tip 22 of the needle 16, by a physician
controlled vacuum source 24 arranged in communication with the
suction lumen 20 by a vacuum line 28 at the proximal end of the
needle 16. A second or delivery lumen 30 is arranged within the
steerable needle 16 to function as a delivery conduit. The delivery
lumen 30 is arranged to bring a fluid or gas from a pressurized
fluid source 32, via a delivery line 34, to the delivery lumen 30,
and out the tip of the needle 22 and into the lipid pool "P", to
permit the treatment of that lipid pool "P" with a medicament or
fluid agent.
[0023] A third lumen 40 may be arranged within the steerable needle
16, which third lumen 40 is arranged to contain an optic fiber 42.
The optic fiber 42 extends from the distal end 22 of that steerable
needle 16, and within that needle 16, and thence proximally from
the proximal end of the needle 16, to a monitor or eye piece 44, to
be viewed by the operating physician, as may be seen in FIG. 2.
This permits the attending physician to view the steering the
needle 16 as necessary and if desired, unless other methods of
guidance are desired, and to apply medicaments and suction as
determined to be needed.
[0024] In one preferred embodiment of the present invention, the
steerable needle 16 is movable longitudinally with respect to the
catheter shaft 14. The steerable needle 16 is preferably also
movable rotationally with respect to that catheter shaft 14 to
provide guidance of that catheter 10 and needle 16 as it travels
the twists and turns of an artery 12. The catheter shaft 14 itself
of course is advancable within the artery 12 itself to the situs of
the lipid pool "P".
[0025] In a further embodiment of the present invention, the
aspiration catheter 10 may have a position-indicating annular-band
46 adjacent it's distalmost end, to provide the attending physician
with means for determining the location of the catheter by magnetic
or electromagnetic means.
[0026] Thus, in operation of the present aspiration catheter 10,
upon insertion of that catheter 10 within a coronary artery 12, and
location of a lipid pool "P" covered by a fibrous cap "C", as
evidenced by the optical determination thereof, or other sensing
means, the needle 16 may then be steered and advanced so as to
penetrate the fibrous cap "C" and suction or treat the lipid
material from its pool "P" beneath the fibrous cap "C" and adjacent
the artery wall. A treating agent may be injected within the
fibrous cap to facilitate removal of the lipid therefrom or to
promote healing of the artery wall once the aspiration catheter 10
and its steerable needle 16 have been removed therefrom. The fluid
introduced into the lipid pool may be a pharmaceutical agent to
render the lipid non-thrombogenic or to facilitate its
solidification.
[0027] By such treatment, vulnerable plaques, heretofore defined as
plaques which are prone, in the presence of an appropriate trigger,
to ulceration, rupture, erosion, or thrombus that can lead to an
acute syndrome, may be rendered innocuous.
* * * * *