U.S. patent number 3,585,983 [Application Number 04/710,596] was granted by the patent office on 1971-06-22 for cardiac assisting pump.
Invention is credited to Paul S. Freed, Adrian Kantrowitz, Wladimir Schilt.
United States Patent |
3,585,983 |
Kantrowitz , et al. |
June 22, 1971 |
CARDIAC ASSISTING PUMP
Abstract
An intra-arterial cardiac assisting device is provided having a
nonelastic polyurethane balloon which is inflated periodically for
diastolic augmentation by utilization of helium. The leading end of
the device, which is passed into the aorta as a catheter, has a
pressure transducer therein.
Inventors: |
Kantrowitz; Adrian (Brooklyn,
NY), Schilt; Wladimir (Brooklyn, NY), Freed; Paul S.
(Brooklyn, NY) |
Family
ID: |
24854701 |
Appl.
No.: |
04/710,596 |
Filed: |
March 5, 1968 |
Current U.S.
Class: |
600/18;
604/103.13; 604/914 |
Current CPC
Class: |
A61M
60/135 (20210101); A61M 60/50 (20210101); A61M
60/40 (20210101); A61M 2025/0002 (20130101); A61M
60/274 (20210101) |
Current International
Class: |
A61M
1/10 (20060101); A61M 25/00 (20060101); A61b
019/00 () |
Field of
Search: |
;128/1,214,344,DIG.3,348 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
Moulopoulos et al. - TRANS. AMER. SOC ARTIFIC. INTER. ORGANS, Vol.
VIII ap. 1962 pp. 85--87 (copy in Gp 335) .
Khalil et al. - TRANS. AMER. SOC. ARTIFIC. INTER. ORGANS, - Vol.
June 1967 - pp.
|
Primary Examiner: Truluck; Dalton L.
Claims
What we claim is:
1. An intra-arterial cardiac assisting pump comprising:
a hollow elongated arterial catheter portion having an outer
diameter sufficiently small to permit the insertion thereof into an
artery, at least the outer surface thereof being provided with a
biologically compatible material;
a hollow elongated, perforated reenforcing element having a leading
end and extending along at least a portion of said catheter and
extending beyond the end of said catheter portion, said perforated
reenforcing element having approximately the same diameter as said
catheter portion and forming an extension thereof;
a very thin-walled, generally inelastic, cylindrical polyurethane
balloon portion surrounding said perforated reenforcing element and
in gas sealing relationship with said catheter portion, said
balloon portion having an area in cross section when inflated of
approximately 20--80 times as great as that of the said reenforcing
element;
means for periodically feeding low density gas to said balloon
through said catheter and reenforcing element to periodically
inflate said balloon to its maximum inelastic diameter; and
internal pressure measuring means including a pressure transducer
located at and connected to the leading end of said reenforcing
element, electrical leads passing from said transducer through said
reenforcing element and catheter, and means to translate the
electrical signal from said transducer.
2. A pump in accordance with claim 1 wherein said transducer is
provided with a rigid housing, said housing comprising said
connection to the end of said reenforcing element.
3. A pump in accordance with claim 2, wherein said catheter is
formed of polytetrafluoroethylene.
4. A pump in accordance with claim 2 wherein said reenforcing
element comprises a flexible braided tube.
5. A pump in accordance with claim 4 wherein said braided tube is
metallic.
6. A pump in accordance with claim 5, wherein said polyurethane
balloon has an inflated diameter on the order of 1--2 cm., wall
thickness on the order of 0.100--0.125 mm., and a length of about
10--17 cm., and wherein said catheter and braided tube have outer
diameters of about 5 and 3--5 mm., respectively.
Description
The present invention relates to a cardiac assisting pump, and,
more particularly, to an autosynchronous intra-arterial balloon
pumping system for temporary cardiac assistance.
Fourteen of every 100 patients with acute myocardial infarction
suffer profound cardiogenic shock. Of these patients, from 9to 13
are unresponsive to medical therapy and need some form of effective
circulatory assistance. Accordingly, a vital need has existed for
quickly combating profound cardiogenic shock in a relatively simple
mechanical manner. While the treatment of cardiogenic shock has
undergone numerous developments in recent years, primarily in the
field of drug therapy, the mechanical devices which have been
suggested (e.g. for elevating diastolic pressure while reducing
systolic pressure) have involved extensive surgical procedures.
Accordingly, the need has existed for speedy initiation of
mechanical diastolic augmentation, and the best mechanical approach
heretofore contemplated has involved intra-arterial balloon
pumping.
In 1962 Moulopoulos et al..sup.1 .sup.1
It is therefore an object of the present invention to overcome the
deficiencies of the prior art, such as indicated above.
It is another object of the present invention to provide for
intra-arterial cardiac assistance in a new, improved and unobvious
manner and to provide a novel intra-arterial cardiac assisting
pump.
It another object of the present invention to provide an
autosynchronous balloon pumping system for temporary cardiac
assistance. It is another object of the present invention to
provide a novel intra-arterial cardiac assisting device providing a
practical means of rapid, effective assistance to the patient in
profound, refractory cardiogenic shock.
It is another object of the present invention to provide an
intra-arterial cardiac assisting pump having a relatively small
diameter catheter, utilizing materials which are biologically
compatible and utilizing a low density driving gas, which pump is
effective in its intended purpose.
It is another object of the present invention to provide an
autosynchronous balloon pumping system for temporary cardiac
assistance having an intra-arterial portion which senses pressures
in the aorta and assists in the correct timing of the pumping.
It is another object of the present invention to provide
intra-arterial cardiac assisting pump which can be simply inserted
into an artery, and which subsequently takes on the shape of the
aorta during use.
These and other objects of the nature and advantages of the present
invention will be more apparent from the following detailed
description taken in conjunction with the drawings wherein:
FIG. 1 is a partly broken away, partly schematic diagram of one
embodiment of an intra-arterial cardiac assisting pump in
accordance with the present invention;
FIG. 2 is a view like FIG. 1, showing another embodiment of the
present invention; and
FIG. 3 is a schematic illustration of an autosynchronous
intra-arterial cardiac assisting balloon pump, showing
extracorporeal components.
An intra-arterial assisting device in accordance with the present
invention comprises, in general, two major components, namely an
extracorporeal unit 10 (FIG. 3) and an intracorporeal unit 12. A
first embodiment of an intracorporeal unit 12 is shown in FIG. 1,
while a second embodiment, similar in many respects to the
embodiment in FIG. 1, is shown in FIG. 2.
Briefly, the intracorporeal unit 12 includes a hollow elongated
arterial catheter portion 14, an inflatable, nonelastic balloon
portion 16, and a perforated reenforcing portion 18. The
extracorporeal unit 10 includes, very generally, a source 50 of gas
under pressure (preferably helium), a solenoid valve unit 52 for
periodically feeding the helium into the intracorporeal unit 12 and
suitable electronic means for receiving a signal from the body in
which the intra-arterial cardiac assisting device has been placed
(such as ECG signals through leads 58 and 56) and using such signal
for the opening and closing periodically of the solenoid valve
52.
The intra-arterial cardiac assisting device of the present
invention works in the following manner. Normally, the heart pumps
blood into the aorta, the body's main artery leaving the heart,
during a period of time termed cardiac systole. The following
period of time, during which the heart is not pumping, but is
filling with blood, in termed cardiac diastole.
When the heart is in need of assistance, the intracorporeal unit is
passed through the body's skin into a suitable artery (such as the
femoral artery) and passed toward the heart so that the balloon 16
is in the thoracic aorta just below the location where the
subclavian artery branches from the aorta. When the electronic
means embodied in the extracorporeal components receives an
appropriate signal from the body, the solenoid valve is actuated so
as to admit helium through the catheter 14, through the
perforations in the reenforcing portion 18, and finally into the
balloon 16 at the beginning of cardiac diastole, thus inflating the
balloon. During cardiac diastole the resistance to flow in the
vessels of the heart, i.e. the coronary arteries, is at a minimum.
Inflation of the balloon 16 at this time increases the flow through
the coronary arteries and pumps blood along the aorta toward the
neck and head and toward the kidneys, liver, stomach and other
organs.
Deflation of the balloon 16 at the end of cardiac diastole aids the
heart by reducing the pressure in the aorta which the heart must
normally pump against during cardiac systole. This permits the
heart to pump a large volume of blood with each contraction and
also reduces the pressure in the left ventricle, or main pumping
chamber of the heart, at the end of cardiac diastole. The combined
effects of inflation and deflation of the balloon in this manner
provide significant aid to the heart in need of assistance.
Describing the intracorporeal unit 12 of FIG. 1 in greater detail,
it will be seen that the leading end 20 of the device comprises a
stainless steel housing 22 in which is incorporated a pressure
transducer 24 having suitable insulated electrical leads 26, which
pass backwardly through the perforated reenforcing element 18 and
along the catheter portion 14, as illustrated, to a junction 28 and
then to an electrical lead carrying portion 30 terminating in an
electrical outlet 32. While the housing 22 is preferably formed of
stainless steel, it will be understood that any rigid, biologically
inert material may be used for such housing. In addition, other
rigid materials can be used and can be coated with a biologically
compatible material such as polyurethane.
The housing 22 is connected to the end of the hollow, elongated,
perforated reenforcing element 18, such as by being inserted
therein. Such reenforcing element 18 preferably comprises a
flexible braided tube of metal wires, such as copper braid,
conventionally used as electrical shielding. Such copper braid has
been found to be highly advantageous since it is flexible and
conforms to the shape of the artery during operation of the
intracorporeal unit, and also permits the flow therethrough of the
inflating gas into the balloon 16. Where the reenforcing element 18
comprises the copper braid, the lead 26 from the pressure sensor
transducer is woven into the copper braid 18.
Along a portion 34 of the device 12 of FIG. 1, the copper braid 18
and the catheter 14 are coextensive, the copper braid being
soldered or otherwise adhered tight over the preferably etched end
of the catheter 14. Overlying the entire copper braid 18, at least
a portion of the housing 22 (preferably the entire housing 22) and
the entire length of the junction portion 34 is the very thin
walled, flexible, generally nonelastic, inflatable balloon 16,
desirably formed of polyurethane. Polyurethane is the preferred
material since it is not only biologically compatible, but it has
the best combination of desirable physical properties such as
abrasion resistance, ease of handling, tensile strength, and
resistance to elastic inflation.
The catheter portion 14 is, as described above, a hollow elongated
tube adapted, along with the housing 22, the reenforcing element 18
and the balloon 16, to be inserted into the artery. It is,
accordingly, essential that the outer diameter of the catheter 14
be sufficiently small to permit its insertion into the artery.
While the catheter 14 may be formed of any suitable material which
is sufficiently flexible to permit it to be bent, or coiled, it is
necessary that its outer surface be provided with a biologically
compatible material. Thus, the catheter 14 may be formed of vinyl
plastic material coated with polyurethane; however, it is
preferably formed of polytetrafluoroethylene which is, itself,
biologically compatible and which has other desirable properties.
Particular advantages of polytetrafluorethylene include its
inertness and its very smooth surface.
It is preferred in the FIG. 1 embodiment that the catheter 14 be
formed of two concentric polytetrafluoroethylene tubes, the outer
of which has been heat shrunk about the inner, the sensor leads 26
being retained between the two concentric tubes. It will be
understood, of course, that the catheter portion 14 is sufficiently
long so that the balloon 16 may be deposited in the aorta while the
junction 28 remains outside the body. The catheter 14 continues
beyond the junction 28, as an extracorporeal tube 36, terminating
in a connector 38 for attachment to the solenoid valve unit 52.
The intracorporeal unit 12 of FIG. 2 is, in many respects, similar
to that described above in relation to FIG. 1. The primary
distinctions include the use of a temperature-compensated pressure
sensor having two transducer elements 24 and 24', and the use of a
copper braid 18 which extends not only the length of the balloon 16
and along only a small portion of the catheter 14, but which spans
the catheter 14 along its entire length, the leads 26 from the
pressure transducer elements 24 and 24' being woven into the copper
braid 18 along its entire length. In addition, an extracorporeal
housing 40 is provided of suitable semiflexible plastic, such as
molded polyurethane, into which the gas connection 38 and the
electrical connection 32 are embedded for improved ease of
connection with the solenoid valve unit 52. Also, instead of the
polytetrafluorethylene catheter, polyurethane is extruded over the
copper braid 18. Since all external surfaces of the entire assembly
except for the connectors to the solenoid valve 52 and the
electrical outlet are made of polyurethane, very highly reliable
junctions between these surfaces can be achieved.
The extracorporeal unit 10 includes, besides the source 50 of
helium under pressure and suitable passageways and pressure
regulating valves and metering devices therealong passing to the
solenoid valve unit 52, as part of the control means, a modified
double beam oscilloscope 60 and a recorder 62. The patient's ECG is
recorded through leads 58 and passed through to the oscilloscope 60
through the leads 56. Central aortic pressure is measured by the
pressure transducer elements 24 and 24' and passed through the
leads 26 to the oscilloscope 60 and from these through leads 66 to
the recorder 62. In turn, the oscilloscope 60 passes a signal
through a lead 64, based on information received through the leads
58 and 26 from the body, to control the opening and closing of the
solenoid valve 52. By means of the modified double beam
oscilloscope 60, a preselected point of the ECG or of the central
aortic pressure controls the solenoid valve 52. Phase and duration
of inflation cycle can be adjusted independently.
The function of the electronic control (e.g. modified dual beam
Tektronix 565 oscilloscope) is to recognize the occurrence of an
R-wave on the ECG initiate a time delay up to the end of cardiac
systole. At the beginning of cardiac diastole, the electronic
control energizes the solenoid valve and maintains it energized
until the end of cardiac diastole. For example, the commercial
oscilloscope is modified by the addition of a relay, controlled by
the B+ gate, which connects power to the solenoid valve.
The following specific example of the manufacture and use of an
intra-arterial cardiac assisting pump is presented by way of
illustration and not by way of limitation, so that those skilled in
the art may better understand how the present invention may be
practiced.
An extracorporeal unit 10, such as shown in FIG. 3, is provided
with a source of helium 50 under pressure and an electronically
controlled solenoid valve 52. The intracorporeal unit comprises a
flexible polyurethane balloon 16 with a "Teflon"
(polytetrafluorethylene) catheter 14 attached to one end, the
entire intracorporeal unit being capable of being sterilized.
The balloon 16 is made by coating a glass mold with a 10--15
percent polyurethane tetrahydrofuran solution. The resulting
balloon has a wall thickness of only 0.100--0.125 mm., but the
material is so tough that it can withstand pressure of 250 mm. Hg.
without undergoing elastic deformation, and it will withstand
considerably greater pressure before bursting. The resultant
balloon 16 thereby provides for a wide margin of safety during
actual use. The so-formed balloon may be 10--17 cm. long and 1--2
cm. in diameter, depending upon the size of the aorta for which it
is intended and the pumping volume required. As illustrated in
FIGS. 1 and 2, the balloon 16 tapers at each end to a cylindrical
sleeve which is about 3 centimeters long and about 0.4 to 0.5
centimeter in diameter.
A section of woven flexible copper tubing (electrical shielding),
approximately 3--5 mm. in diameter, is introduced into the balloon
16, spanning its length, to serve as the elongated, perforated
reenforcing element 18.
A pressure transducer 24 of the semiconductors strain-gauge type,
provided with a stainless steel housing 22, is then tightly fitted
into the end of the device proximal to the heart. The junction is
then sealed with a coating of the polyurethane solution. Thus
positioned, the pressure transducer is insensitive to pressure
changes within the balloon 16, but records blood pressure changes
at the site where the device is positioned, such as within the
aorta.
The catheter portion 14 is then interfitted with the end of the
balloon 16 and the end of the copper braid 18 along the portion 34.
The catheter 14 may fit inside the copper braid 18, or it may fit
over the end of the balloon 16. In the latter case, the catheter
consists of two concentric, heat-shrinkable Teflon tubes. The
catheter 14 is 60--70 cm. long and has a 5 mm. outside diameter.
The leads 26 from the transducer 24 are interwoven with the braid
18 along its length and, where the braid 18 ends, the leads may
either be carried within the catheter 14, or where the catheter
comprises two concentric tubes, between such tubes. As is seen, the
catheter connects the intra-arterial balloon 16 and the
extracorporeal unit 10.
For catheterization, the intracorporeal unit is stiffened by the
insertion of a long catheter guide which reaches to the leading end
of the braided tube 18 which elongates the tube 18 thereby reducing
its diameter to aid insertion. When the balloon 16 has been placed
within the aorta, the guide is withdrawn and the woven copper tube,
acting as a reenforcing means, allows the balloon 16 to regain its
flexibility.
In operation, the assembled unit is driven by a low density gas,
preferably helium. It is necessary to use a low density gas to
assure its rapid passage through the narrow catheter and into the
balloon 16 through the mesh of the copper tubing.
By means of the modified dual-beam oscilloscope 60, a preselected
point either of the central aortic pressure, as obtained from the
transducer 24, or of the ECG, controls the solenoid valve of the
pumping unit causing the helium to flow into the balloon 16 very
quickly to inflate such balloon 16 to its preselected nonelastic
maximum diameter.
It will be obvious to those skilled in the art that various changes
may be made without departing from the scope of the invention and
that the invention is not to be considered limited to what is shown
in the drawings and described in the specification.
* * * * *