U.S. patent application number 10/701786 was filed with the patent office on 2004-07-08 for balloon occlusion diameter and pressure measuring devices and methods of use.
Invention is credited to Addis, Bruce.
Application Number | 20040133157 10/701786 |
Document ID | / |
Family ID | 23188206 |
Filed Date | 2004-07-08 |
United States Patent
Application |
20040133157 |
Kind Code |
A1 |
Addis, Bruce |
July 8, 2004 |
Balloon occlusion diameter and pressure measuring devices and
methods of use
Abstract
The invention provides a device having first and second
balloons. Each of the first and second balloons communicates with
an inflation lumen. A differential pressure gauge communicates with
both inflation lumens. Each of the inflation lumens also
communicates independently with a pump for inflating the balloon.
The pressure gauge may include a shut-off valve for terminating
inflation in the second balloon when the pressure within the first
balloon exceeds the pressure in the second balloon. The pressure
gauge may also include a pressure limiter. Methods of using the
devices for measuring diameter and pressure of a balloon occluder
deployed in a vessel or body cavity are disclosed.
Inventors: |
Addis, Bruce; (Redwood City,
CA) |
Correspondence
Address: |
O'MELVENY & MEYERS
114 PACIFICA, SUITE 100
IRVINE
CA
92618
US
|
Family ID: |
23188206 |
Appl. No.: |
10/701786 |
Filed: |
November 4, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10701786 |
Nov 4, 2003 |
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09687922 |
Oct 13, 2000 |
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6656154 |
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09687922 |
Oct 13, 2000 |
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09307092 |
May 7, 1999 |
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6146357 |
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Current U.S.
Class: |
604/100.01 |
Current CPC
Class: |
A61M 25/1018 20130101;
A61M 2025/1068 20130101; A61M 25/10187 20131105; A61M 2025/1059
20130101; A61M 25/10184 20131105; A61M 2025/0001 20130101; A61M
25/10182 20131105 |
Class at
Publication: |
604/100.01 |
International
Class: |
A61M 029/00 |
Claims
What is claimed is:
1. A balloon occlusion inflation apparatus, comprising: a first
balloon which communicates with a first inflation lumen; a second
balloon which communicates with a second inflation lumen; and a
pressure gauge communicating with the first inflation lumen and
independently and simultaneously communicating with the second
inflation lumen to permit a comparison of a detected pressure of
the first balloon with a detected pressure of the second
balloon.
2. The apparatus of claim 1, wherein the first and second balloons
are elastomeric.
3. The apparatus of claim 1, wherein the first and second balloons
are non-elastomeric.
4. The apparatus of claim 1, further comprising a first pump that
communicates with the first inflation lumen and a second pump that
communicates with the second inflation lumen, wherein the first and
second pumps are syringes.
5. The apparatus of claim 4, wherein the syringes are tandem acting
syringes.
6. The apparatus of claim 1, wherein the pressure gauge includes a
shut-off valve, operably associated with the second inflation
lumen.
7. The apparatus of claim 1, wherein the pressure gauge includes a
pressure limiter.
8. The apparatus of claim 1, wherein the pressure gauge is a
differential pressure gauge.
9. The apparatus of claim 1, further comprising a first pump
communicating with the first inflation lumen and a second pump
communicating with the second inflation lumen.
Description
[0001] This is a continuation of U.S. application Ser. No.
09/687,922, filed Oct. 13, 2000, which is a continuation of U.S.
application Ser. No. 09/307,092, filed May 7, 1999, now U.S. Pat.
No. 6,146,357, all of which are incorporated herein by reference in
its entirety.
FIELD OF THE INVENTION
[0002] The present invention relates generally to medical devices
useful for measuring the diameter and pressure of a balloon
occluder deployed within a vessel. More particularly, the devices
provide information on when the balloon occluder engages the vessel
wall, diameter of the vessel wall, and force exerted on the vessel
wall.
BACKGROUND OF THE INVENTION
[0003] Balloon occlusion devices are commonly deployed within a
vessel during various cardiovascular surgeries to provide isolation
of blood flow. During conventional or minimally invasive surgeries,
including coronary artery bypass grafting, heart valve repair or
replacement, septal defect repair, pulmonary thrombectomy,
atherectomy, aneurysm repair, aortic dissection repair and
correction of congenital defects, for example, circulatory
isolation of the coronary blood flow from the peripheral vascular
system is often required to establish cardiopulmonary bypass.
Instead of using the traditional methods of aortic clamping, a
balloon occluder is sometimes used to isolate blood flow in the
aorta. Presently, balloon occluders are built to expand to the
approximate lumenal diameter of the vessel, i.e., a balloon
occluder with a smaller diameter would be used for the carotid
artery while larger balloons are used in the aorta. Balloon
occlusion devices are also used in other nonvascular procedures,
such as dilation of an esophageal stricture in patients with
achalasia, or dilation of an intra and/or extrahepatic bile duct in
patients with biliary stenosis.
[0004] There are several disadvantages associated with the current
methods of inflating a balloon occluder in a vessel or body cavity.
First, the optimal size of the balloon occluder for occluding the
lumen of the vessel or the body cavity is unknown and is usually
estimated according to the average lumenal diameter. The vessel may
be affected by atherosclerosis, and the actual lumenal diameter may
be reduced. Second, as the balloon is inflated to occlude the lumen
of the vessel or body cavity, the point of contact of the perimeter
of the balloon with the wall of the vessel or body cavity is
uncertain. The operator can only estimate an acceptable level of
wall distention. Third, the pressure generated by the expanded
balloon on the wall of the vessel or body cavity is unknown.
Complications due to over-inflation of the balloon may occur,
including (1) atherosclerotic plaque rupture leading to distal
embolization, (2) dissection of the vessel wall, (3) pseudoaneurysm
formation due to subintimal hemorrhage, (4) aneurysm formation due
to hyperextension and weakening of the vessel wall, (5)
diverticulum formation due to weakening of the body tissue, and (6)
vessel wall rupture or organ perforation.
[0005] New devices and methods are thus needed for balloon
occlusion of a vessel or body cavity, in order to provide
information on the effective diameter of the vessel or body cavity
and allow an operator to optimally control the inflation of the
balloon without damage to the vessel wall or body tissue.
SUMMARY OF THE INVENTION
[0006] The invention provides devices and methods for controlling
the inflation of balloon occlusion devices. One embodiment of the
devices includes first and second balloons. The first balloon is
adapted for insertion into a patient's vessel or body cavity. The
balloons may be elastomeric or non-elastomeric balloons. Each of
the two balloons communicates with an inflation lumen. Each
inflation lumen communicates independently with a pump for
inflating the balloon. Both lumens communicate with a differential
pressure gauge, which measures the pressure inside each balloon,
compares both pressures, and displays the information.
[0007] In another embodiment, the pumps are syringes, which are
adapted for infusion of air or fluid into the balloon. The syringes
may operate in tandem for inflating the balloons simultaneously. In
still another embodiment, the pressure gauge includes a shut-off
valve, operably associated with the second inflation lumen. The
valve enables the pressure gauge to terminate inflation into the
second lumen and balloon after the pressure in the first balloon
exceeds a certain threshold. In certain embodiments, the gauge may
include a pressure limiter which limits the pressure in the first
balloon from exceeding a set threshold, thereby avoiding
over-inflation of the first balloon inside the vessel or body
cavity.
[0008] The invention provides methods for measuring the pressure of
a balloon occluder deployed in a patient's vessel or body cavity,
e.g., bile duct. In a first method, using the devices described
above, the first balloon is inserted through an incision into the
lumen of a patient's vessel, e.g., aorta, or body cavity while
maintaining the second balloon outside the patient's body. The
first and second balloons are inflated simultaneously at the same
rate of inflation by operating the pumps, which infuse air or fluid
into the inflation lumens. The pressure within the first and second
balloons are measured and compared by the differential pressure
gauge, which comparison indicates when the first balloon engages
the lumenal wall of the vessel or body cavity. As the first balloon
contacts the vessel wall, the pressure in the first balloon rises
disproportionately compared to the second balloon. The operator may
then terminate inflation in the first balloon to avoid
over-inflation.
[0009] In another method, when the pressure in the first balloon
exceeds the pressure in the second balloon, the pressure gauge may
activate the shut-off valve, thereby terminating the inflation of
the second balloon. The gauge may be reset to measure the pressure
within the first balloon and the atmosphere. In this way, any
increase in the pressure in the first balloon is caused by the
resistance of the vessel wall against the expanding balloon. The
less compliant the vessel, e.g., artery with atherosclerotic
plaque, the higher the resistance of the vessel wall and the higher
the pressure registered in the pressure gauge. In the embodiment
where the pressure gauge includes a pressure limiter, the limiter
may sound an alarm when the pressure in the first balloon exceeds a
set threshold, thereby avoiding complications associated with
over-inflation of the balloon occluder.
[0010] It will be understood that there are several advantages to
using the balloon occlusion measuring devices and methods disclosed
herein. For example, the devices (1) notify the physician when the
balloon contacts a vessel wall, (2) provide information on the
diameter of the vessel wall, (3) provide information on pressure
exerted on the vessel wall, (4) can be employed in any vessel with
or without stenosis, (5) can be employed to occlude or dilate a
body cavity, and (6) minimize complications associated with
over-inflation of the balloon occluder, i.e., wall rupture,
dissection, pseudoaneurysm, and/or embolization.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] FIG. 1 depicts an embodiment of the balloon occluder
pressure measuring device according to the present invention.
[0012] FIG. 2A depicts a first balloon deployed in the aorta and a
second balloon outside the aorta.
[0013] FIG. 2B depicts the first balloon of FIG. 2A engaging the
aortic wall.
[0014] FIG. 2C depicts a graph of the pressure differential between
the first and second balloons versus time.
DETAILED DESCRIPTION
[0015] The balloon occluder pressure measuring devices and methods
are most useful in providing optimal inflation of a balloon
occluder deployed in a patient's vessel, e.g., aortic occlusion for
cardiopulmonary bypass, and in preventing complications associated
with balloon over-inflation. It will be understood that the devices
and methods may also be used to provide optimal balloon inflation
in occluding or dilating a patient's body cavity, e.g., the
esophagus in patients with achalasia or the bile duct in biliary
stenosis.
[0016] In FIG. 1, first balloon 10, which is inserted in the lumen
of vessel 100, communicates with inflation lumen 12. Second balloon
20, which is outside the vessel, communicates with inflation lumen
22. Both lumens 12 and 22 communicate with differential pressure
gauge 50. Inflation lumens 12 and 22 also communicate,
respectively, with pumps 15 and 25, shown here as syringes. Syringe
16 has plunger 15 disposed within lumen 14 of the syringe. Syringe
26 has plunger 25 disposed within lumen 24 of the syringe. The
syringes deliver air or fluid to the balloons through their
respective inflation lumens. Proximal ends of plungers 15 and 25
may be activated in tandem to simultaneously inflate balloons 10
and 20. In use, after balloon occluder 10 is deployed in vessel
100, balloons 10 and 20 are inflated simultaneously, and at the
same rate by advancing plungers 15 and 25 distally, forcing fluid
or air through lumens 14 and 24 to inflate balloons 10 and 20. The
pressure differential between balloons 10 and 20 is measured and
indicated on pressure gauge 50.
[0017] In FIG. 2A, balloon 10, having pressure P1 inside the
balloon, is deployed within vessel 100, and balloon 20, having
pressure P2 inside the balloon, is outside the vessel. As both
balloons are inflated, balloon 10 engages the wall of vessel 100 as
shown in FIG. 2B. Once contact is achieved with the vessel wall,
the pressure within balloon 10 rises disproportionately to that of
balloon 20, i.e., P1>>P2. The relationship between the
pressure differential for balloons 10 and 20 (P1/P2) with inflation
time (t) is illustrated in FIG. 2C. Time t1 indicates when balloon
10 engages the vessel wall as depicted in FIG. 2B. Before t1, the
pressure differential between balloons 10 and 20 remains relatively
constant. After t1, the pressure differential increases due to
resistance from the vessel wall.
[0018] In the embodiments where the pressure gauge includes a
shut-off valve operably associated with the second inflation lumen,
inflation of balloon 20 may be terminated when the first balloon
makes contact with the vessel wall. The gauge may be reset to
measure the pressure within balloon 10 and the atmosphere, so that
P1/P2 reflects the resistance generated by the vessel wall. The
less compliant the vessel, e.g., artery with atherosclerosis
plaque, the higher the resistance of the vessel wall. In this way,
the devices provide the physician information on (1) when the
balloon occluder device contacts the vessel wall, (2) the effective
lumenal diameter of the vessel, and (3) force exerted on the vessel
wall.
[0019] In still another embodiment, the pressure measuring device
need not include a second balloon for pressure monitoring outside
the body. In this embodiment, the physician carefully monitors the
pressure gauge, noting when a significant pressure increase occurs
(t=t1, when the balloon engages the vessel wall). Balloon inflation
is then terminated to avoid vessel hyperextension.
[0020] The length of the inflation lumen will generally be between
10 and 200 centimeters, preferably approximately between 30 and 150
centimeters. The inner diameter of the inflation lumen will
generally be between 0.05 and 0.5 centimeters, preferably
approximately between 0.1 and 0.3 centimeters. The diameter of the
expanded occluder will generally be between 0.3 and 2 centimeters,
preferably approximately 0.5 and 1.0 centimeters. The foregoing
ranges are set forth solely for the purpose of illustrating typical
device dimensions. The actual dimensions of a device constructed
according to the principles of the present invention may obviously
vary outside of the listed ranges without departing from those
basic principles.
[0021] Although the foregoing invention has, for the purposes of
clarity and understanding, been described in some detail by way of
illustration and example, it will be obvious that certain changes
and modifications may be practiced which will still fall within the
scope of the appended claims.
* * * * *