U.S. patent application number 13/591267 was filed with the patent office on 2013-06-20 for system and method for removing blood containing contrast dye.
The applicant listed for this patent is IBRAHIM RASHID AL-RASHDAN. Invention is credited to IBRAHIM RASHID AL-RASHDAN.
Application Number | 20130158460 13/591267 |
Document ID | / |
Family ID | 46689704 |
Filed Date | 2013-06-20 |
United States Patent
Application |
20130158460 |
Kind Code |
A1 |
AL-RASHDAN; IBRAHIM RASHID |
June 20, 2013 |
SYSTEM AND METHOD FOR REMOVING BLOOD CONTAINING CONTRAST DYE
Abstract
The system for removing blood containing contrast dye includes
an inner catheter having a fixed proximal end and a distal free
end, and an outer catheter coaxially disposed around a portion of
the inner catheter, defining an inner channel and an annular outer
channel. The fixed end of the inner catheter is coincident with the
proximal end of the outer catheter, and the distal end of the inner
catheter extends outward from the outer catheter. An annular
suction orifice is defined between the distal end of the outer
catheter and the inner catheter. First and second balloons are
mounted adjacent the distal ends of the outer and inner catheters.
The distal free end of the inner catheter extends beyond the second
balloon. In use, the first and second balloons are inflated in the
coronary sinus and blood containing contrast dye is then removed
from between the first and second balloons.
Inventors: |
AL-RASHDAN; IBRAHIM RASHID;
(QORTABA, KW) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
AL-RASHDAN; IBRAHIM RASHID |
QORTABA |
|
KW |
|
|
Family ID: |
46689704 |
Appl. No.: |
13/591267 |
Filed: |
August 22, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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13330601 |
Dec 19, 2011 |
8251942 |
|
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13591267 |
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Current U.S.
Class: |
604/6.09 ;
604/101.01; 604/508 |
Current CPC
Class: |
A61M 2025/0004 20130101;
A61M 25/04 20130101; A61M 25/10 20130101; A61M 2025/1047
20130101 |
Class at
Publication: |
604/6.09 ;
604/101.01; 604/508 |
International
Class: |
A61M 1/34 20060101
A61M001/34; A61M 25/10 20060101 A61M025/10 |
Claims
1. A system for removing blood containing contrast dye, comprising:
an inner catheter having a fixed proximal end and a distal free
end; an outer catheter having a proximal end and a distal end, the
inner catheter being partially coaxially disposed within the outer
catheter defining an annual outer channel between the inner
catheter and the outer catheter, the fixed proximal end of the
inner catheter being coincident with the proximal end of the outer
catheter, the inner catheter partially extending outward from the
distal end of the outer catheter defining an annular suction
orifice the distal end of the outer catheter and the inner
catheter; a first balloon mounted on the outer catheter adjacent
the distal end of the outer catheter; a second balloon mounted on
the inner catheter adjacent the distal free end thereof, the distal
free end extending beyond the second balloon; a first lumen in
communication with the first balloon, the first lumen having a
first inflation port; a second lumen in communication with the
second balloon, the second lumen having a second inflation port;
and a third lumen in communication with the annular outer channel
and the annular suction orifice for draining blood from between the
first and second balloons, the third lumen having a first suction
port.
2. The system for removing blood containing contrast dye as recited
in claim 1, further comprising a guide covering the annular suction
orifice, the guide centering the inner catheter and having a
plurality of apertures defined therein communicating with the
annular suction orifice.
3. The system for removing blood containing contrast dye as recited
in claim 1, further comprising a fourth lumen in communication with
the inner catheter for draining blood through the distal free end
of the inner catheter and the inner channel, the fourth lumen
having a second suction port.
4. The system for removing blood containing contrast dye as recited
in claim 1, further comprising a guide wire disposed within the
third lumen.
5. The system for removing blood containing contrast dye as recited
in claim 1, wherein said second balloon is smaller than said first
balloon.
6. The system for removing blood containing contrast dye as recited
in claim 1, wherein said inner catheter is formed from a softer
material than said outer catheter.
7. A method for removing blood containing contrast dye, comprising
the steps of: providing an inner catheter having a fixed proximal
end and a distal free end; providing an outer catheter having a
proximal end and a distal end, the inner catheter being partially
coaxially disposed within the outer catheter defining an annual
outer channel between the inner catheter and the outer catheter,
the fixed proximal end of the inner catheter being coincident with
the proximal end of the outer catheter, the inner catheter
partially extending outward from the distal end of the outer
catheter defining an annular suction orifice the distal end of the
outer catheter and the inner catheter; providing a first balloon
mounted on the outer catheter adjacent the distal end of the outer
catheter; providing a second balloon mounted on the inner catheter
adjacent the distal free end of the inner catheter, the distal free
end extending beyond the second balloon; inflating the second
balloon to anchor the inner catheter in place in a patient's
coronary sinus vein with the distal free end thereof positioned
adjacent the patient's lateral vein; inflating the first balloon to
anchor the outer catheter to seal the ostium of the patient's
coronary sinus vein; removing blood containing contrast dye from
between the first and second balloons by suction through the
annular suction orifice; and deflating the first and second
balloons when the blood containing the contrast solution between
the first and second balloons has been removed.
8. The method for removing blood containing contrast dye as recited
in claim 7, further comprising the step of removing a second volume
of blood containing contrast dye from the patient's coronary sinus
vein distal to the inner catheter.
9. The method for removing blood containing contrast dye as recited
in claim 7, further comprising the step of hemo-filtering the
patient's blood and returning the hemo filtered blood to the
patient's bloodstream.
10. A system for removing blood containing contrast dye,
comprising: an inner catheter having a fixed proximal end and a
distal free end; an outer catheter having a proximal end and a
distal end, the inner catheter being partially coaxially disposed
within the outer catheter defining an annual outer channel between
the inner catheter and the outer catheter, the fixed proximal end
of the inner catheter being coincident with the proximal end of the
outer catheter, the inner catheter partially extending outward from
the distal end of the outer catheter defining an annular suction
orifice the distal end of the outer catheter and the inner
catheter, the inner catheter being formed from a softer material
than the outer catheter; a first balloon mounted on the outer
catheter adjacent the distal end of the outer catheter; a second
balloon mounted on the inner catheter adjacent the distal free end
thereof, the distal free end extending beyond the second balloon; a
first lumen in communication with the first balloon, the first
lumen having a first inflation port; a second lumen in
communication with the second balloon, the second lumen having a
second inflation port; and a third lumen in communication with the
annular outer channel and the annular suction orifice for draining
blood from between the first and second balloons, said third lumen
having a first suction port.
11. The system for removing blood containing contrast dye as
recited in claim 10, further comprising a guide centering the inner
catheter, the guide having a plurality of apertures defined therein
communicating with the annular suction orifice.
12. The system for removing blood containing contrast dye as
recited in claim 10, further comprising a fourth lumen in
communication with the inner catheter for draining blood through
the distal free end thereof and the inner channel, the fourth lumen
having a second suction port.
13. The system for removing blood containing contrast dye as
recited in claim 10, further comprising a guide wire disposed
within the third lumen.
14. The system for removing blood containing contrast dye as
recited in claim 10, wherein said second balloon is smaller than
said first balloon.
15. The system for removing blood containing contrast dye as
recited in claim 10, wherein the distal free end of the inner
catheter has a plurality of apertures formed through a sidewall
thereof.
Description
BACKGROUND OF THE INVENTION
[0001] 1. Field of the Invention
[0002] The present invention relates to coronary angioplasty
devices and procedures, and particularly to a system and method for
removing blood containing contrast media, or dye, that provides for
the removal of the contrast media used during angioplasty
procedures from the coronary sinus of a patient's heart before the
blood containing the media enters the right atrium and circulates
through the bloodstream to the kidneys, potentially causing
contrast-induced nephropathy (CIN).
[0003] 2. Description of the Related Art
[0004] Percutaneous transluminal coronary angioplasty is frequently
used in treating coronary atherosclerosis, which produces areas of
blockage within a coronary artery. However, prior to performing
percutaneous transluminal coronary angioplasty, and during the
procedure itself, iodine containing dye or other contrast material
is injected into a patient's coronary arteries through a catheter.
This iodine solution is fluorescent and enables the coronary
arteries to be clearly illustrated for the physician.
[0005] A serious problem associated with the use of such contrast
solutions exists. The use of such solutions may lead to
contrast-induced nephropathy. Contrast-induced nephropathy can
result in transient or permanent renal impairment or failure of a
patient's kidneys. It is well known that renal dysfunction is
associated with the use of radiographic contrast media, and that
the dysfunction may range from a transient slight increase in serum
creatinine levels to renal failure requiring transient or long-term
dialysis.
[0006] Many patients require revascularization of more than a
single vessel. However, when there is danger of contrast-induced
renal failure, the vessels are operated on in separate procedures
at greatly increased cost and additional risk of arterial puncture.
Therefore, it is highly desirable or imperative to eliminate the
risk of renal failure.
[0007] Further, there are many other patients with chronic renal
insufficiencies who must wait 24 to 48 hours in the hospital before
undergoing percutaneous transluminal coronary angioplasty in order
to space the kidney load associated with the contrast load. Still
others, particularly the elderly with a pre-existing renal
insufficiency, make up a large group in which angioplasty is
avoided due to multi-vessel disease and multi-vessel intervention,
which may lead to renal failure.
[0008] Contrast-induced nephropathy can be prevented if the
contrast solution is kept away from the kidney. However, once the
dye has been mixed with blood, the conventional method to separate
the two is by filtration (for example, through dialysis). Dialysis
relies on diffusion down a concentration gradient and is not
completely effective if the concentration of dye in the blood to be
filtered is low. Furthermore, the flow rates of conventional
hemodialysis procedures are too high for patients who are
undergoing angioplasty, and these patients typically do not
tolerate wide fluctuations in blood pressure, as is common with
hemodialysis.
[0009] Thus, a system and method for removing blood containing
radiographic contrast media from the venous system of the heart
before the blood circulates to the kidneys is desired for solving
the aforementioned problems.
SUMMARY OF THE INVENTION
[0010] The system and method for removing blood containing
radiographic contrast media used for angioplasty procedures relates
to the removal of blood containing contrast dye solution from the
coronary sinus of the patient's heart before the blood containing
the dye enters the right atrium and circulates through the
bloodstream to the kidneys, potentially causing contrast-induced
nephropathy (CIN). The system for removing blood containing
contrast dye includes an inner catheter, having opposed fixed and
free ends, and an outer catheter. The inner catheter is partially
disposed coaxially within the outer catheter, defining inner and
outer channels. The fixed proximal end of the inner catheter is
positioned within the outer catheter, and the distal end of the
inner catheter partially extends outward from the outer catheter.
An annular suction orifice is defined between the outer catheter
and the inner catheter at the distal end of the outer catheter. A
guide may be further provided for covering the annular suction
orifice and holding the inner catheter in place with respect to the
outer catheter. The guide has openings or apertures formed
therethrough, allowing blood containing the contrast dye to be
suctioned therethrough.
[0011] A first balloon is mounted on the outer catheter adjacent
the annular suction orifice, and a second balloon is mounted on the
inner catheter adjacent the distal free end thereof, the suction
orifice being disposed between the two balloons. The distal free
end of the inner catheter extends beyond the second balloon. A
first lumen is in communication with the first balloon, and the
first lumen terminates in a first inflation port. Similarly, a
second lumen is in communication with the second balloon, and the
second lumen terminates in a second inflation port. A third lumen
is in communication with the outer channel and annular suction
orifice for draining blood from between the first and second
balloons. The third lumen terminates in a first suction port. A
fourth lumen communicates with the inner channel of the inner
catheter to drain contrast dye from beyond the second balloon, and
is attached to a second suction port. The free end of the inner
catheter may have a plurality of openings or apertures formed
through a sidewall thereof. Thus, if the free end contacts the wall
of the coronary sinus and becomes blocked, or is otherwise blocked,
the blood containing the contrast dye can still be suctioned
through the openings or apertures.
[0012] In use, the catheters, which have a curvature that
facilitates the insertion of the system in the coronary sinus, are
inserted into the coronary sinus, the outer catheter extending to
the ostium and the inner catheter extending into the sinus. The
first and second balloons are inflated after introducing a contrast
solution into a patient's blood stream. Blood containing contrast
solution from between the first and second balloons is then
removed. The second balloon is inflated first in order to anchor
the inner catheter in place in the coronary sinus, the free end
thereof being positioned adjacent the patient's lateral vein.
Preferably, the inner catheter is formed from a softer material
than the outer catheter, thus allowing the outer catheter to be
used for positioning, and preventing damage to the inner wall of
the coronary sinus vein.
[0013] The larger first balloon is inflated in the right atrium,
forming a seal at the ostium of the coronary sinus, forming a
vacuum between the first and second balloons. The blood containing
the contrast solution is then removed from between the inflated
first and second balloons by suction through the annular suction
orifice into the outer channel formed between the first and second
catheters, and blood containing the contrast dye is also removed
distal to the second balloon by suction through the inner channel
defined by the inner catheter. The first and second balloons are
deflated when the blood containing the contrast solution from
between the first and second balloons has been removed. The blood
containing the contrast dye is drained from the patient. The
physician may optionally choose to filter the blood containing the
contrast dye to remove the dye and return the filtered blood to the
patient's bloodstream.
[0014] These and other features of the present invention will
become readily apparent upon further review of the following
specification and drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] FIG. 1 diagrammatically illustrates a system for removing
blood containing contrast dye according to the present
invention.
[0016] FIG. 2 is a schematic diagram showing the first step in a
method for removing blood containing contrast dye, showing
placement of the outer catheter in the ostium of the coronary
sinus.
[0017] FIG. 3 is a schematic diagram showing the second step in a
method for removing blood containing contrast dye, showing
extension of the inner catheter into the coronary sinus between the
posterior/inferior interventricular vein and the lateral vein.
[0018] FIG. 4 is a schematic diagram showing the third step in a
method for removing blood containing contrast dye, showing
inflation of the second balloon in the coronary sinus vein to
anchor the system.
[0019] FIG. 5 is a schematic diagram showing the fourth step in a
method for removing blood containing contrast dye, showing
inflation of the first balloon in the right atrium to seal the
ostium of the coronary sinus.
[0020] FIG. 6 is a schematic diagram showing the fifth step in a
method for removing blood containing contrast dye, showing suction
applied to remove blood containing contrast dye from between the
two balloons through the outer lumen, and also suction applied to
remove blood containing contrast dye distal to the inner catheter
through the inner lumen.
[0021] FIG. 7 diagrammatically illustrates the system for removing
blood containing contrast dye in position within the patient's
heart.
[0022] FIG. 8 diagrammatically illustrates the system for removing
blood containing contrast dye positioned within the coronary sinus
of the patient's heart.
[0023] Similar reference characters denote corresponding features
consistently throughout the attached drawings.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0024] The system and method for removing blood containing contrast
dye relates to the removal of blood containing contrast dye
solution from the coronary sinus of a patient's heart before the
blood containing the dye enters the right atrium and circulates
through the bloodstream to the kidneys, potentially causing
contrast-induced nephropathy (CIN). As best shown in FIG. 1, the
system for removing blood containing radiographic contrast media
(dye) 10 includes an inner catheter 16 having a fixed proximal end
and a free distal end, and an outer catheter 18 coaxially disposed
around a portion of the inner catheter 16. The inner catheter 16 is
partially disposed coaxially within the outer catheter 18, defining
inner and outer channels. The fixed proximal end of the inner
catheter 16 is positioned within the outer catheter 18 coincident
with the proximal end of the outer catheter 18, and the distal end
of the inner catheter 16 partially extends outward from the outer
catheter 18. An annular suction orifice 42 is defined between an
inner wall of the outer catheter 18 and an outer wall of the inner
catheter 16.
[0025] A first balloon 12 is mounted on the outer catheter 18
adjacent the distal end of the outer catheter 18, and a second
balloon 14 is mounted on the inner catheter 16 adjacent the distal
free end 40 thereof The distal free end 40 extends beyond the
second balloon 14. As shown in FIG. 1, when inflated, the second
balloon 14 is preferably smaller than the first balloon 12. As will
be described below in greater detail, the first balloon 12 is
dimensioned and configured to block or seal, when inflated, the
ostium of the coronary sinus vein CS, and the second balloon 14 is
dimensioned and configured to lodge against the inner wall of the
coronary sinus vein CS to anchor the system 10 and form a seal for
blood removal between the pair of balloons. The larger first
balloon 12 preferably has a diameter of approximately 20-30 mm, and
the smaller second balloon 14 preferably has a diameter of
approximately 8-10 mm.
[0026] A first lumen 28 is in communication with the first balloon
12, and the first lumen 28 terminates in a first inflation port 30.
Similarly, a second lumen 36 is in communication with the second
balloon 14, and the second lumen terminates in a second inflation
port 32. Alternatively, a single lumen may be used to inflate both
balloons 12, 14 by attaching a three-way valve to the inflation
port. In the first position, the valve would open the lumen to the
second balloon 14 for inflation thereof, in a second position the
valve would close the lumen to the second balloon and open the
lumen to the first balloon 12 for inflation thereof, and in the
third position the valve would open the lumen to both balloons for
deflation of the balloons 12, 14.
[0027] A third lumen 26 is further in communication with the outer
catheter 18 and the annular suction orifice 42 for draining blood
through the outer channel from between the first and second
balloons 12, 14. The third lumen 26 terminates in a first suction
port 34. A guide wire may further be disposed within the third
lumen 26, such as a conventional 0.035 inch guide wire or the like,
for positioning the inner catheter 16 and outer catheter 18. The
guide wire may then be removed once the guide wire contacts the
wall of the coronary sinus CS, thus indicating proper positioning
and initiating inflation of the balloons.
[0028] First and second inflation ports 32 may be connected to any
suitable source of pressurized air or the like for selectively
sequentially inflating first and second balloons 12, 14, as will be
described in detail below. The first suction port 34 may be
connected to a vacuum pump or the like for providing negative
pressure through the third lumen 26, allowing for the draining of
blood containing contrast dye solution through orifice 42 to avoid
the risk of contrast-induced nephropathy.
[0029] A fourth lumen 24 is in communication with the inner
catheter 16 for draining blood through the distal free end 40 and
inner channel defined by the inner catheter 16. The fourth lumen 24
terminates in a second suction port 22. As shown in FIG. 1, a guide
20 may be provided for centering the inner catheter 16. The guide
20 may cover the annular suction orifice 42, but have a plurality
of apertures therein to permit the contrast-containing blood to be
suctioned into the annular suction orifice 42. The free end of
outer catheter 18, which defines the suction orifice 42, may have
the guide 20 integrally formed thereon. The second suction port 22
may also be connected to an external vacuum pump or the like for
providing negative pressure through fourth lumen 24, which is in
communication with inner catheter 16, allowing for the draining of
blood containing contrast dye solution through the distal free end
40 of the inner catheter 16 to further avoid the risk of
contrast-induced nephropathy.
[0030] In use, the first and second balloons 12, 14 are inflated
after introducing a contrast dye solution D into a patient's blood
stream, the second balloon being inflated first to anchor the
system, the first balloon 12 then being inflated to seal the ostium
of the coronary sinus CS, creating a vacuum between the two
balloons. Blood containing the contrast solution dye is then
removed from between the first and second balloons 12, 14. FIG. 2
illustrates the system 10 being initially inserted, with the outer
catheter 18, which is used for positioning, being located in the
patient's ostium. FIG. 3 shows the inner catheter 16 extended
further along the patient's sinus, past the posterior inferior
interventricular vein IV, and with the first balloon 12 being
positioned in the right atrium RA. At this point, both balloons 12,
14 have not yet been inflated.
[0031] In FIG. 4, the second balloon 14 is inflated first to anchor
the inner catheter 16 in place in the patient's coronary sinus vein
CS, with the distal free end 40 of the inner catheter 16 being
positioned adjacent the patient's lateral vein LV. Preferably, the
inner catheter 16 is formed from a softer material than the outer
catheter 18, thus allowing the outer catheter 18 to be used for
positioning (in the patient's ostium), and preventing damage to the
inner wall of the coronary sinus vein CS. The second balloon 14,
when inflated, blocks blood flow into the coronary sinus vein CS.
As shown in FIGS. 7 and 8, the stiffer material forming the outer
catheter 18 preferably maintains outer catheter 18 in a
substantially inverted J-shape, allowing the outer catheter 18 to
be positioned within the inferior vena cave (IVC) of the patient's
heart, extending through the right atrium (RA) and into the
coronary sinus (CS).
[0032] As shown in FIG. 5, the first balloon 12 is then inflated to
anchor the outer catheter 18 in place with respect to the patient's
right atrium RA. The inflated first balloon 12 blocks blood flow
from the coronary sinus to the right atrium RA during the
procedure. As shown in FIG. 6, the blood containing the contrast
dye solution D is then removed from between the inflated first and
second balloons 12, 14 by suction through the annular suction
orifice 42 into the annular outer channel. Contrast dye solution D
is also removed distal to the inner catheter 16 by suction into the
inner channel. The first and second balloons 12, 14 are deflated
when the blood containing the contrast dye solution D from between
the first and second balloons 12, 14 has been removed. For
relatively long procedures, involving multiple injections of
radiographic contrast media, the system 10 may further be connected
to an external hemp filtration system, allowing the drained
dye-containing blood to be filtered and then returned to the
patient's bloodstream.
[0033] As shown, the system 10 acts as a closed circuit to remove
the contrast dye solution D contaminated blood to prevent its
arrival at the kidneys. Thus, the system 10 provides for avoidance
of contrast-induced nephropathy in high risk patients. It should be
noted that the distal free end 40 of the inner catheter 16
preferably has a plurality of openings or apertures 41 formed
through the sidewall thereof. Thus, if free end 40 contacts the
wall of the coronary sinus and becomes blocked, or is otherwise
blocked, the blood containing the contrast dye D can still be
suctioned through the openings or apertures 41.
[0034] It is to be understood that the present invention is not
limited to the embodiments described above, but encompasses any and
all embodiments within the scope of the following claims.
* * * * *