U.S. patent number 3,592,183 [Application Number 04/828,151] was granted by the patent office on 1971-07-13 for heart assist method and apparatus.
Invention is credited to Erwin J. Klink, David H. Watkins.
United States Patent |
3,592,183 |
Watkins , et al. |
July 13, 1971 |
HEART ASSIST METHOD AND APPARATUS
Abstract
Method and apparatus for assisting a failing heart by sucking
blood out of the left ventricle during normal systolic action,
while at the same time blocking flow to the aorta, and during
diastolic action, when the aortic valve is closed, forcing blood
into the aorta and thence to the arterial tree. More particularly,
there is provided a catheter with openings back from the tip
thereof and with a radially surrounding collapsible portion, which
catheter is inserted in the aorta with tip immediately above the
aortic valve. A reciprocating external pump connected to the
catheter on withdrawal stroke sucks blood out of the left ventricle
and on pressure stroke forces the blood under pressure through the
aorta and arterial system. Suitable provision is made for timing
the sequence and pace of the pump with respect to the natural beat
of the heart or, as desired, to a predetermined beat in point of
time. Provision also is made for controlling the volume of blood
moved by the pump. Additional provision is made for precisely
locating the tip of the catheter immediately adjacent the aortic
valve. Where desired, provision is made for directly observing the
blood pressure and automatically controlling the same at a
predetermined figure. Other provision is made for supplying
additional blood.
Inventors: |
Watkins; David H. (Des Moines,
IA), Klink; Erwin J. (Albuquerque, NM) |
Family
ID: |
25251028 |
Appl.
No.: |
04/828,151 |
Filed: |
May 27, 1969 |
Current U.S.
Class: |
600/18; 604/28;
604/118; 604/67; 604/6.11 |
Current CPC
Class: |
A61M
60/00 (20210101); A61M 25/04 (20130101); A61M
60/268 (20210101); A61M 60/122 (20210101); A61M
60/857 (20210101); A61M 60/50 (20210101); A61M
60/40 (20210101); A61M 60/562 (20210101); A61M
2205/32 (20130101); A61M 60/833 (20210101) |
Current International
Class: |
A61M
25/04 (20060101); A61M 25/02 (20060101); A61M
1/10 (20060101); A61b 019/00 (); A61m 001/03 () |
Field of
Search: |
;128/1,2.05,245,344,348--351 ;3/214,1 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Other References
Goldfarb et al. TRANS. AMER. SOC. ARTIF. INTER. ORGANS Vol. XI 1965
pp. 31--35 128-1 .
Schilt et al. TRANS. AMER. SOC. ARTIF. INTER. ORGS. Vol. XIII 1967
pp. 322--328 128-1.
|
Primary Examiner: Truluck; Dalton L.
Claims
We claim:
1. Method of improving the action of the ailing heart of a patient
wherein an open end catheter is inserted within the aorta adjacent
the aortic valve of the left ventricle of the heart, said catheter
having associated therewith flow-restraining means, which method
comprises intermittently withdrawing blood directly from the left
ventricle through said catheter with each systolic pulsation of the
heart; restraining flow of the blood into and from the aorta;
temporarily storing the blood of each such pulsation neat the
patient; and with each succeeding diastolic period removing the
restraint and moving the blood from storage back through the
catheter into the aorta under pressure.
2. System and apparatus for aiding the ailing heart of a patient
comprising in combination, blood storage means; catheter means with
an open distal end for introduction into the aorta just above the
aortic valve; pump means connected to the proximal end of the
catheter for withdrawing blood from the left ventricle during
systolic pulsation and passing the same to such storage means and
during succeeding diastolic period moving said blood from said
storage means into the aorta; valve means adjacent the distal end
of the catheter for restraining the passage of blood into and from
the aorta during such systolic pulsation but permitting passage
during diastolic period; means for detecting and recording the
pulse rate and instantaneous blood pressure of the patient; and
control means for said pump means triggered and controlled by said
detecting and recording means to maintain a predetermined
pressure.
3. System and apparatus for aiding the ailing heart of a patient
comprising in combination, means for intermittently storing the
blood of such patient; catheter means with an open distal end for
introduction into the aorta with distal end just above the aortic
valve; pump means connected to the proximal end of said catheter
means for withdrawing blood from the left ventricle during systolic
pulsation and passing the same to such storage means, and during
succeeding diastolic period moving said blood into the aorta;
collapsible valve means adjacent the distal end of the catheter in
the aorta for restraining the passage of blood into the same during
systolic pulsation of the heart but permitting passage of blood
during diastolic period; oscillographic display means for
connection to the patient for displaying the electrical wave form
of the heart pulse of the patient; and the arterial pressure wave
form of the patient and means responsive to a predetermined point
of the heart pulse wave to control the action of said pump
means.
4. System and apparatus for aiding the ailing heart of a patient
comprising in combination catheter means having an elongated member
with bore extending therethrough and having an open proximal end
portion, said open end distal portion adapted for introduction into
the aorta with distal end just above the aortic valve; pump means
connected to the proximal end of said catheter means for
withdrawing blood from the left ventricle; collapsible valve means
adjacent and rearward of said distal end of the catheter means for
restraining passage of blood into and from the aorta during the
withdrawal of blood form the left ventricle; reservoir means
connecting with said pump means for storing withdrawn blood; means
for detecting and recording the pulse rate and instantaneous blood
pressure of the patient and control means for said pump means to
properly control the action of said pump to maintain a
predetermined blood pressure by said detecting and recording
means.
5. In apparatus for aiding the ailing heart of a patient, catheter
means for introduction into aorta with distal end just above the
aortic valve, comprising an elongated member with bore extending
therethrough and having an open end distal portion and an open
proximal portion; and back from said open end distal portion,
circumferential collapsible imperforate membrane valve means
flaring out radially and in proximal direction from the central
axis of the elongated member of said catheter means for temporarily
closing the aorta.
6. In apparatus for aiding the ailing heart of a patient, catheter
means for introduction into the aorta with distal end just above
the aorta vala, comprising an elongated member with bore extending
therethrough and having an open end distal portion and an open
proximal portion; an opaque tip in advance of said open end distal
portion; and circumferential flaring imperforate membrane valve
means intermediate said elongated member and extending in proximal
direction radially about said elongated member of said catheter
means for temporarily closing off the aorta.
7. In apparatus for aiding the ailing heart of a patient, catheter
means for introduction into the aorta with distal end just above
the aorta valve, comprising an elongated member with bore extending
therethrough and having an open end distal portion and an open
proximal portion; and, back from said open end distal portion,
circumferential collapsible imperforate membrane valve means
radially flaring out from the central axis of said elongated member
for temporarily closing the aorta, said catheter means including in
said elongated member an opening back of said flaring membrane
valve means.
8. In apparatus for aiding the ailing heart of a patient, catheter
means for introduction into the aorta with distal end just above
the aortic valve, comprising an elongated member with bore
therethrough and an open end distal portion and open proximal
portion with opaque tip portion and openings back of said tip
portion; and collapsible imperforate membrane valve means radially
flaring out from a central axis of said elongated member for
temporarily closing a aorta, said elongated member having an
opening back of said valve means to assure blood circulation
immediately above said valve means and to assure easy withdrawal of
catheter means from the patient.
9. System and apparatus for aiding the ailing heart of a patient by
withdrawing blood from the left ventricle during systolic pulsation
and during succeeding diastolic period moving said blood into the
aorta, comprising catheter means for withdrawing blood from said
left ventricle; valve means on said catheter means for restraining
the back-flow of blood from the aorta during such withdrawal during
systolic pulsation, but permitting blood flow therethrough during
diastolic period; pump means connecting with said catheter means;
means for controlling the pump means to withdraw blood from the
patient in one cycle of pump operation and in another cycle supply
blood to the patient; means accepting electrical stimulus from
apparatus connected to the patient; relay means a actuated thereby
for control of supply power to the pump means; and timing means for
determining the duration of the application of power to said pump
means withdrawal and discharge control.
10. System and apparatus for aiding the ailing heart of a patient
by withdrawing blood from the left ventricle during systolic
pulsation and during succeeding diastolic period moving said blood
into the aorta comprising catheter means for withdrawing blood from
said left ventricle; valve means on said catheter means for
restraining the back-flow of blood from the aorta during such
withdrawal during systolic pulsation, but permitting blood flow
therethrough during diastolic period; pump means; means for
controlling the same to withdraw blood from the patient by way of
said catheter means; means for controlling the pump means to supply
blood to the patient by way of said catheter means; pulser means
for controlling the pulse of the patient adjustable to desired rate
of heart beat connected to said withdrawal and supply control
means; and timing means connected to said withdrawal control means
for determining the duration of the application of power from said
wtihdrawal control means to said pump means.
11. System and apparatus for aiding the ailing heart of a patient
by withdrawing blood from the left ventricle during systolic
pulsation and during succeeding diastolic period moving said blood
into the aorta comprising catheter means for withdrawing blood from
said left ventricle; valve means on said catheter means for
restraining the back-flow of blood from the aorta during such
withdrawal during systolic pulsation, but permitting blood flow
therethrough during diastolic period; pump means; means for
controlling said pump means to withdraw blood from the patient;
means for controlling the pump means to supply blood to the
patient; blood pressure detector means for connection to an artery
of the patient; and adjustable electrical power means controlled by
said detector means for controlling a supply of power to said
withdrawal control means.
Description
As a matter of introduction, our invention is general relates to
the art of assisting the natural heart action of an ailing cardiac
patient.
One of the objects of our invention is the provision of a method
and apparatus for assisting or substituting for the insufficient
natural heart function, this enabling the heart itself to work with
a minimum of effort, or indeed no effort, for substantial periods
of time.
Another object is to provide a simple, direct and effective method
of assisting the ailing heart even to the extent of massaging the
same, where desired, and to provide comparatively simple apparatus,
readily available, and easily accommodated to a heart patient,
wherein there is a minimum burden on the heart and particularly the
left ventricle during the systolic action, followed by diastolic
action, all while precisely observing and controlling the rate of
heart beat and the volume of blood being moved.
A further object is the provision of pumping means for effecting
and precisely limiting the volume of blood moving between the
ailing left ventricle and the vascular system of the patient.
A still further object is the provision of a catheter for ready
insertion in the aorta immediately above the aortic valve, with
provision for precise location, maximum acceptability by the
patient and with maximum ease of removing the same without untoward
effect.
Other objects of the invention in part will become apparent as the
description of our method and apparatus progresses and in part will
be particularly pointed to.
Our invention, accordingly, consists in the combination of elements
and features of construction of our system and apparatus, in the
several operational steps employed, and in the relation of each of
the same to one or more of the others, all as more particularly
described herein and particularly set out in the claims at the end
of this specification.
BACKGROUND OF THE INVENTION
As an aid to a better understanding of certain features of our
invention, it may be well to note at this point that situations do
occur where the heart action of a patient is wholly insufficient to
supply the patient's bodily needs. In some instances this is
attributed to a lack of sufficient muscular activity of the heart
itself. In others it is attributed to some damage directly
introduced through bodily accident. And in still others, it may be
attributed to a general overall deteriorating condition of the
patient or to a trauma, ischemic shock or postoperative shock.
With a loss or substantial decrease in heart activity, we feel that
it is the action of the left ventricle which is principally
responsible. It is our thought that it is the muscular activity of
the left ventricle which is not sufficient to supply the blood
requirements of a patient. In point of fact, it is our thought that
in many instances the action is not sufficient to completely
discharge the blood from the left ventricle. And, moreover, that
the action is not sufficient to force the blood into the aorta, and
thence to the arterial system of the patient.
While much of the problem has been recognized by prior
investigators, and many have offered solutions, these have not been
entirely satisfactory. Some of the prior systems are too
complicated to be thoroughly reliable. Others, although less
involved, are inadequate. For example, in even the best of the
prior art systems, there does not seem to result a complete
discharge of blood from the heart during the systolic phase.
Neither does it appear to force the blood into the aorta during the
diastolic phase in such controlled and measured amount as to most
nearly agree with normal heart action; in many instances the blood
appears to surge forward either too abruptly or too slowly for
precise agreement.
An object of our present invention, therefore, is to provide a
method, system and apparatus which overcomes the difficulties found
in the systems of the prior art, in which method, system and
apparatus there is given maximum aid to the ailing heart, with a
best control of the action of the left ventricle, that is, full
withdrawal of blood from the same during systolic action, and a
best discharge of blood into the aorta and arterial tree, this in
best agreement with normal discharge of an unailing heart. It is a
further object to provide for adding to or subtracting from the
volume of blood of the patient. Another is to provide means for
stimulating the action of an ailing heart in simple, direct and
reliable manner.
SUMMARY OF THE INVENTION
Turning now to the practice of our invention, it is our view that
proper relief for the left ventricle of an ailing heart for a
matter of minutes, or even hours, frequently rests the heart
sufficiently to further function in normal manner. Accordingly, we
provide a catheter which conveniently is introduced into either the
aorta or the left subclavian artery by means of an arteriotomy
incision, this having been exposed by a small cervical incision.
The proximal end of the catheter protrudes from the artery and is
provided with a plastic tube connected to a reciprocating pump. The
distal end of the catheter is directed toward the heart. This end
of the catheter, which we preferably provide with an opaque tip
such as stainless steel, is positioned by way of X-ray, or even
ultrasonic examination, to a point approximately 1 centimeter above
the aortic valve ring. The catheter is secured in place by the use
of arterial snares in the manner customarily employed by
surgeons.
Now the catheter itself is provided with a number of holes
immediately back from the tip. These, of course, allow for entrance
and discharge of blood. The catheter also is provided with a
radially flaring membrane valve, this being positioned at a point
immediately back of the holes near the catheter tip. This valve is
circumferential of the catheter and nicely fits against the inner
walls of the aorta. A further hole or aperture is provided in the
catheter just back of the flaring membrane valve. This small
aperture permits a flow of blood into and out of the catheter
immediately above the base of the flaring membrane, thus preventing
blood from possibly stagnating or clotting at the base of the
membrane. Upon removal, this aperture permits a flow of blood into
the catheter which allows a gradual collapse of the membrane, thus
permitting its withdrawal from the artery through which it had been
inserted.
In our method and apparatus provision also is made for reciprocal
pumping means connecting with the tubing leading from the proximal
end of the catheter to withdraw blood from the left ventricle
during systolic action of the heart and then discharge blood back
through the catheter into the aorta during the diastolic
action.
And in accordance with our invention, the pump means noted
comprises a chamber having expansible walls, with appropriate
provision for expanding these walls, thereby increasing the
capacity of the pump chamber, and then contracting these walls and
decreasing the pump chamber capacity, to cause ingress and egress
of blood into the chamber. Where desired, provision is made for
supplying the pump chamber with additional blood, or even saline
solution, by way of a suitable reservoir.
During the systolic period and the withdrawal of blood from the
left ventricle, the membrane valve of the catheter is expanded due
to the action of the back pressure coming from the blood in the
arterial tree and aorta, this as against the reduced pressure
obtaining with withdrawal under the action of the pump. And during
the diastolic period, the pressure of blood supplied by the pump
assures closure of the aortic valve, collapse of the
circumferential membrane valve about the catheter, and the
resulting flow of blood into the arterial tree.
In our system and apparatus the action of the reciprocating pump is
effectively controlled by amplified pulsations, either taken
directly from the patient himself, or from electrocardiac apparatus
connected to the patient in customary manner. Suitable provision,
of course, is made for desired control of the pulse rate of the
apparatus, as well as systolic and diastolic pressures.
As an alternate feature of construction, we employ, where desired,
means for automatically maintaining systolic and diastolic
pressures at particular predetermined values. In this construction
there is provided a second catheter, this being introduced into one
of the main arteries of the patient, which supplies blood to a
second chamber with expansible walls, which chamber, in turn,
actuates a control for operation of the reciprocating pump. Visual
means may be supplied to precisely indicate the blood pressures
involved.
The system and apparatus in accordance with the teachings of our
invention precisely remove all, or a desired portion of the blood
in the left ventricle of the patient during systolic action, the
amount removed depending upon the capability of the natural heart
action of the patient and the setting of the system controls.
Following this action, and with diastolic action of the heart there
is a reversal of flow, and in our system and apparatus the blood is
forced into the aorta, and thence the arterial system.
It will be seen that our system performs all, or a desired part, of
the work of the left ventricle by allowing it to naturally expand
and fill with blood, and then by suction removing the blood from
the ventricle, allowing the ventricle to contract. The left
ventricle, then, is forced to function and physically move through
a heart beat cycle without, however, being called upon to expend
any substantial effort of its own. In general, the system operates
at pressures normally encountered in the heart, although it has a
capability of exceeding normal pressures for the purpose of drawing
blood through the heart, as in the case of an ailing patient with
completely arrested heart action, and hence no arterial
pressure.
As a further feature, the system has the capability of oscillating
the blood back and forth rapidly in the aorta, and at the same time
removing small amounts of blood from the left ventricle. Such
action in effect mechanically massages the heart. This frequently
is beneficial in causing an ailing heart to again function in
normal manner.
The total weight of the apparatus is about 50 pounds, making it
easily portable and hence most advantageous as compared to the
bulky and weighty apparatus of the prior art. A further advantage
lies in its use with a readily available 115 volt alternating
current power supply.
BRIEF DESCRIPTION OF THE DRAWINGS
In the accompanying drawings in which we disclose a preferred
embodiment of our invention:
FIG. 1 is a schematic disclosure of the electromechanical
blood-handling system and apparatus of our invention, showing
catheter, pump and control panel of that system;
FIG. 2 is a detached sectional view, on enlarged scale, of the pump
disclosed in FIG. 1;
FIG. 3 is a detached sectional view of the base portion of the pump
of FIG. 2 taken at an angle of 90.degree. from that disclosure;
FIG. 4 is a disclosure, on somewhat enlarged scale, of the catheter
of the system and apparatus of FIG. 1;
FIG. 5 is a schematic illustration of the catheter of FIG. 4, also
on enlarged scale, as operatively positioned in the aorta and
immediately above the aortic valve, this latter in open position
and with blood being sucked out of the left ventricle and into the
catheter and with the catheter circumferential membrane valve
expanded to prevent flow from the aorta back into the catheter;
FIG. 6 is a corresponding schematic illustration of the catheter,
on enlarged scale, during a next one-half cycle of operation, with
the aortic valve in closed position and with blood flowing out of
the catheter and into the aorta, the circumferential membrane
catheter valve being collapsed to permit the flow;
FIG. 7 discloses, on enlarged scale, the control panel of the
system and apparatus of FIG. 1;
FIG. 8 is a schematic diagram of the electrical circuitry of our
system and apparatus as controlled by the switches and pointers of
the panels of FIGS. 1 and 7;
FIG. 9 is a schematic drawing of the electrical circuitry of a
system for amplifying control from auxiliary equipment which may be
used with out system and apparatus;
FIG. 10 discloses a blood pressure detector and control equipment,
some parts being shown in partial section, which equipment, as an
alternate, may be employed in the system and apparatus of our
invention; and
FIG. 11 discloses in partial section a blood reservoir and
appropriate connections which may be employed with the pump of FIG.
1, 2 and 3.
Like characters denote like parts throughout the several views of
the drawings.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
Referring now to the preferred illustrative embodiment of our
invention, attention is directed to the several views of the
drawings. It will be seen that our system and apparatus essentially
comprises catheter 30--33, blood pump 18--28, and the electrical
control system 2--16. As noted above, catheter 30--33 is partially
inserted into the aorta (FIG. 5) so that the distal end is
immediately above the discharge side of the aortic valve. The
proximate end is connected to a tube 29, which leads to blood pump
18--28 (FIG. 1). Blood from the left ventricle is withdrawn by the
pump, this by way of catheter 30--33 and tube 29 and into chamber
22 of the pump. Upon reversal of the pump, blood from the chamber
is passed back through tube and catheter and into the aorta (FIG.
6).
a. The Catheter
The catheter of our invention is so constructed that during the
withdrawal portion of the operating cycle of the pump, the blood
from the left ventricle is sucked into catheter 30 by way of
opening 34 at the distal end of the same (FIGS. 4 and 5). A
membrane valve 32 radially and circumferentially surrounding the
catheter, is restrained in expanded position by way of radial
filaments 31 serving to prevent any flow of blood back from the
aorta and into the catheter under the back pressure obtaining in
the arterial tree. The external membrane valve of the catheter is
fashioned of a thin plastic or, as desired other imperforate
membrane such as thin rubber, or either of these two additionally
supplied with a thin fabric cover. External catheter valve 32 in
the expanded position (FIG. 5) additionally serves to support the
walls of the aorta from partial collapse under the suction action
of the pump.
Upon reversal of the pump action during the next half-cycle of
operation, this being timed with the normal diastolic action of the
left ventricle, blood from the pump passing through and out of the
catheter effects a collapse of the circumferential membrane valve
(FIG. 6), and a consequent flow of blood into the aorta, and thence
to the arterial system of the patient.
b. The Pump
Now the ventricle pumping system of our invention (FIG. 1)
envisions electrical supply cable 1 leading to control panel 2--11
and the power supply panel 12--16 to pump 18--28, this by way of
cable 17. The pump itself (FIG. 2) comprises a chamber having
expandible walls, these being in the form of circumferential
bellows 22, with lower end secured to pump base 26 by way of ring
24 threadedly engaging base 26, and upper end secured to pump head
35 by way of ring 23 threadedly engaging the pump head. Bellows 22
is interiorly treated with silicone or other substance compatible
with blood. And pump base 26 and head 35 are fashioned of plastic,
such as acrylic resin, or of bronze or other metal interiorly
coated with Teflon or other silicone. A crossbar 20 secured at head
35 pivotally engages with armatures 21b and 25b of respective
electrical solenoids 21 and 25. The two solenoids are supported on
base member 28 by way of respective brackets 36 and 37. The pump
chamber may be exhausted by way of exit port 35a maintained in
closed position by way of translucent screw cap 29 and exiting
one-way valve 35b. Additions may be made to the chamber by way of
ingress port 35c maintained closed by screw cap 18 and one-way
intake valve 35d.
Upon energizing the upper solenoid windings 21a and 25a of the two
solenoids 21 and 25 the respective armatures 21b and 25b are drawn
downwardly and well into coils 21a and 25a. Movement of the two
upper armatures carries the two lower armatures 21c and 25c into a
"down" position because of the nonmagnetic links 21d and 25d
interconnecting upper and lower armatures. With a downward movement
of the upper armatures, the bar 20, pivotally connected with the
upper armatures, and head 35 of the pump, is drawn downwardly. The
blood content of the pump chamber is forced out by way of egress
port 40 and into catheter 30 by way of interconnecting tube 29, as
discussed above. Upon completion of the downward stroke of the pump
and deenergizing of the solenoids 21 and 25, with the next
half-cycle of operation the lower solenoid windings 21e and 25e are
energized, this forcing the armatures 21c and 25c upwardly into the
position shown in FIG. 2 and carrying with them the upper
armatures, by way of links 21d and 25d, and the pump head 35, thus
expanding the pump chamber.
The pump itself has a stroke of about 13/8 inches, this being that
of the armatures of solenoids 21 and 25, the two exerting a
combined force of about 30 pounds. The diameter of chamber 22 is
about 3 inches. As a consequence, it will discharge or accept some
100 milliliters of blood per inch of compression or expansion. It
is designed to discharge or take in any amount of blood up to a
maximum of 100 milliliters, and may be operated at positive or
negative pressures up to 8 pounds per square inch. The maximum
power and pump capacity, of course, well exceeds the requirements
met with in actual practical use.
The solenoids of our pump apply full available power in less than
0.009 seconds from the time a trigger signal is received. This
prompt response is such that the control of the pump may be made by
the "R" wave of an electrocardiograph, or the like, triggered from
auxiliary equipment without necessity for the introduction of
either predicting or delayed circuits. The system responds so
quickly that when triggered by an "R" wave, the intraventricular
pressure does not rise, but on the contrary, remains significantly
low, and thus reduces the work load of the ailing left ventricle.
The advantage of this type of operation is that the pump remains in
proper synchronization with the natural heart, regardless of the
fact that the natural heart beat may be irregular.
As a further feature of our pump, any air or gas from the blood is
immediately swept to the top of the blood chamber. Such air or gas
is visible to the operator through translucent closure cap 19. And
by unscrewing the cap, the air or gas may be quickly released.
Although with the solenoid stroke of about 13/8 inches, and of
course corresponding stroke of pump head 35, there is a discharge
or change of only some 100 milliliters of blood per inch of
movement, the total capacity of the pump chamber amounts to about
500 milliliters. And the design is such that blood entering the
base port 40 under the action of the pump suction is inclined to
centrally rise, as in the case of a fountain. With reversal of the
pump, however, the blood is inclined to be funneled downwardly by
way of the sloping sidewalls 26a of the pump base and into port 40.
In this way the blood inside of the pump is circulated and
constantly changing.
The parts of pump 18--28 which are exposed to blood, notably
sidewalls, base and head, are smooth and compatible with blood.
There is an absence of rubbing, pinching, or rolling parts of the
pump in contact with the blood. The several features of our pump
combine to provide a capability of pumping blood with no more
damage to the blood, for example hemolysis or conversion of
fibrinogin to fibrin threads, than might be expected in the natural
vascular system. And as a further feature, the system and apparatus
of our invention is such that there is an immediate and direct
relationship between motor, pump and blood being moved in and out
of the vascular system. Moreover, our system assures establishing
and maintaining any desired blood pressure, as more fully described
below. But it is the instantaneous response to a monitoring signal
that assures precise movement of the blood, precision of control
being furthered by positioning pump 18--28 immediately adjacent to
the patient, with a minimum length of tubing 29 between pump and
catheter, this reducing the amount of blood in the system to a
minimum figure and minimizing the amount of blood being moved back
and forth. Instantaneous response is realized by virtue of the
minimal mass of blood.
Attention now is more particularly directed to the electrical
circuitry employed in the system and apparatus of our invention. A
patient with ailing heart whose left ventricle is incapable of
maintaining normal blood pressure, that is, whose blood pressure
has dropped to some 60 millimeters of mercury systolic and 40 mm.
Hg diastolic pressure, obviously is approaching a terminal
condition. Located in a hospital, having an intensive care unit
with electrocardiograph, his electrocardiogram and blood pressure
waves are being developed on an oscilloscope. The "R" wave of the
patient which appears on the oscilloscope conveniently is employed
as a trigger for the system of our invention.
c The Pump Controls
The catheter 30-34, as more particularly discussed above, is
inserted with distal end about 1 centimeter above the aortic valve.
The precise positioning is gauged by X-ray examination, made
possible by the opaque tip 33, or by the ultra sound. Synchronizing
switch 6 (FIGS. and 8) is turned to an "Off" position, the pump
withdraw timer 9 is set at 0.3 seconds, the pulser rate 7 is set at
a rate slightly lower than the patient's heart beat, and the pulser
switch 5 is turned to "On" position. The withdraw power control 12
and the discharge power control 16 are set at the 25 percent figure
shown on their respective dials (FIG. 7). The "R" wave from the
electrocardiograph is employed as a control, the electrical energy
from this wave being plugged into the external trigger input 4. And
to readily observe the pulsing of withdrawal and discharge of the
pump, energy from the two pump controls also is fed by way of
respective outlets 39 and 41 into the electrocardiograph. With the
settings noted, the power switch 15 is turned to the "On"
position.
Now as the "R" wave input to the input connection 4 passes a
preestablished figure of 0.5 volts, it triggers the rectifier 45,
which then permits a passage of power from the DC power supply 46
and the limit switch 27 to close the solid state relay 47. With
closure of that relay, the AC power from the main line 1 is
connected through the synchronous switch 6 to the withdrawal timer
9 and to the pump withdrawal power control 12. This is the
situation obtaining the illustrated in FIG. 8.
Upon energizing pump withdrawal power control 12, current is
supplied pump 18--28, more particularly the lower solenoid coils
21e and 25e (FIG. 2), which then pull armatures 21c and 25c
respectively into the position shown in FIG. 2 from a lower
position not shown, all as more particularly described above. In
this action, the armatures 21b and 25b of the upper solenoids are
lifted by way of the nonmagnetic linkages 21d and 25d to the
position shown in FIG. 8. And with this movement, cross-link 20 and
pump head 35 are lifted, effecting an expansion of the pump chamber
and resultant suction of blood by way of catheter 30--33 and
connecting tube 29 from the ailing ventricle of the patient.
As blood is withdrawn from the catheter, a pressure differential
develops between distal end 34 of the catheter and the upper
section of the aorta. Also between the distal end of the catheter
and the aorta valve. As a result, blood flowing from the upper
section of the aorta causes circumferential membrane 32 of the
catheter to expand and block the flow of blood from the upper
portions of the aorta. And as a further feature, the pressure
differential between catheter and aortic valve causes the latter to
pen and allow the catheter to exhaust the blood from the left
ventricle. Actually, the two functions noted happen so rapidly that
blood is being withdrawn from the left ventricle a few milliseconds
prior to the time that the left ventricle naturally contracts and
discharges blood. As a consequence, the ventricle contracts in
absence of blood pressure or, as desired, at some predetermined
reduced pressure, this depending upon the setting of the pump
withdrawal power control 12. The above description covers the first
half-cycle of the operation of our ventricular pumping system and
apparatus.
In the succeeding half-cycle of operation, that is, the half-cycle
wherein blood is pumped into the aorta and thence to the vascular
system of the patient, after the initial trigger which comes from
the leading edge of the "R" wave of the electrocardiogram and after
some 0.3 seconds following the initial triggering of the system,
timer 9 opens the withdrawal power control line 9a (FIG. 8), which
serves to disconnect power control 12 from the line and consequent
deenergization of lower pump solenoids 21e and 25e. At the same
time, control power is supplied to the pump discharge power control
16 through closure of the circuit at 9b. This serves to instantly
energize the upper solenoid windings 21a and 25a, with resulting
pulling of armatures 21b and 25b respectively into a downward
position within the coils, and consequent pushing of the lower
armatures 21c and 25c downwardly into a position in which armature
21c strikes the pump discharge limit microswitch 27.
Actuation of switch 27 immediately removes power from rectifier 45
and deenergizes relay 47, thereby breaking connection to both pump
withdrawal power control 12 and pump discharge power control 16. No
supply of power to either of the pump power controls may then be
had until relay 47 is again actuated, this by way of a further
trigger input to connection 4 and consequent reactivation of
rectifier 45 and the resulting supply of DC power from power supply
46 through the activated rectifier 45 to relay 47. Incidently, as
the electrical circuit is broken at the pump discharge limit
microswitch 27, connection is made through rectifier 27a and
resistor element 27b to ground. This connection obtains until
switch 27 is reset.
One of the provisions of our system and apparatus is that as the
operator observes the patient's blood pressure wave form on an
oscillographic display, adequate adjustment may be made either to
increase the systolic pressure or decrease the same as desired. In
this it is merely necessary to adjust the withdrawal timer 9 to
either a longer or a shorter timing operation, and to adjust the
pump power controls 12 and 16 to supply greater or less power to
the withdrawal phase and discharge phase of the pump. In making
these adjustments after an initial setting is had of timer 9, both
the withdrawal and the discharge power controls are gradually
changed. This gradually raises the arterial blood pressure due to a
gradual increase in the volume of the blood which is pumped. After
the desired pressure has been reached, an occasional adjustment of
withdrawal control 12 will effectively correct a pressure that is
either too high or too low; no corresponding change need be made
either to the pump discharge power control 16 or the timer 9.
In our system and apparatus, provision also is made for assuring
continued heart action of the patient even in such instances where
the "R " wave becomes most irregular or virtually ceases. This is
achieved by pulser 7. As previously indicated, the pulser 7 of our
apparatus customarily is set at a rate just slightly less than the
patient's heart beat. This is done by timing the natural beat of
the heart and setting the pulser 7 so that it sends out a pulse
just after the natural "R" wave triggers the system. Since the
system is already triggered by the "R" wave, no untoward incident
accompanies the further triggering by the pulser. One advantage of
using the pulser in this manner, however, is that if the "R" wave
becomes irregular, or the natural heart beat fails, then the pulser
will initiate a trigger at a time only slightly later than would
have been effected by the normal "R" wave. In accordance with the
provisions of our system and apparatus, after receiving an impulse
from pulser 7, a pumping cycle ensures, as described above. A
further cycle requires a further triggering effect by the "R" wave
if properly functioning, or if not properly functioning, by the
pulser 7. The pulser action has the effect of stabilizing or
continuing the forced heart action even if the natural action of
the left ventricle has completely stopped. In such event, the
continuance of the regular pump cycle will pull blood through the
heart and maintain desired blood pressure. And of course the
continued pumping initiated by the pulser forces blood through the
coronary arteries and thus feeds the heart muscle. At the same time
this blood forces the left ventricle through a pumping cycle even
if the left ventricle is entirely incapable of discharging blood
through its natural action. Such enforced action is greatly
beneficial to an ailing or failing heart, permitting significant
and radial recovery.
During the process of recovery, the operator notes an improved
blood pressure due to the recovering left ventricle, then reduces
the withdrawal power of the pump by lowering the setting of control
pointer 12e. Further reduction in pump action may be continued
until it becomes apparent that the left ventricle of the patient is
capable of supporting its work load and that the pumping system is
no longer required.
d. Alternate Controls
As a further feature of our invention, provision is made for
automatic control of blood pressure. In this we provide an
automatic blood pressure control plug-in amplifier 41 (FIG. 9)
which is connected to the pump withdrawal power control 12 by way
of connection 60 (FIG. 8). By setting potentiometer 12 to a fairly
high value by pointer 12e, say 75 percent, blood will be withdrawn
at the maximum reasonable volume. A higher setting would increase
the blood pressure beyond a desirable high value. The purpose of
amplifier 41 is to control power control 12 so that the withdrawal
stroke is just enough to maintain a desired pressure level.
Potentiometer 41c is set so that pump 18--28 is operating by visual
observation at a presumed proper level. As the blood pressure
increases beyond a controlled level, the voltage applied to pump
withdrawal power control 12 also is increased. This causes the
transistor 41d to conduct more heavily and power is pulled through
the full wave bridge rectifier 41e and from the gate of the double
rectifier to withdrawal power control 12, thereby lowering the
voltage applied to control 12. As the control gate voltage is
lowered, the output power of withdrawal control to the withdrawal
pump solenoids 21e and 25e (FIGS. 1 and 2) also is lowered. This in
turn lowers the blood pressure because of the decreased amount of
blood being withdrawn by each stroke of the pump.
As the blood pressure is lowered beyond the control level, this is
reflected by applying more power to the withdrawal of solenoid
coils 21e and 25e. And this in turn increases the blood pressure.
Thus, the setting of potentiometer 41c of amplifier 41 (FIG. 9)
corresponds to some controlled blood pressure. Moving the
potentiometer control 41c to the right increases the control level,
and moving the potentiometer control to the left decreases the
control level.
In situations where a patient has virtually no heart beat, pulser
7, as more particularly described above, serves to initiate a
trigger impulse and keep the system functioning. A desirable level
of systolic pressure, however, may not be obtainable. And in such
circumstance, amplifier 41 is employed. This serves to assure
maximum power in an attempt to maintain a predetermined level of
blood pressure. With partial recovery of the activity of the left
ventricle, there is a slight increase in the blood pressure. This
increase is reflected by a visible decrease in the volume of blood
withdrawn by the pump, and by longer rest periods upon completion
of the pump discharge cycle. The operator then may increase the
control level gradually by adjusting the pointers 12e and 16e of
controls 12 and 16. And after each increase in blood pressure, he
may wait until there is a further decrease in the activity of the
withdrawal pump, this indicating that the left ventricle has
enjoyed further recovery in order to support the blood pressure
being controlled. If during this time the patient's heart is found
to skip a beat, pulser 7 will automatically initiate a trigger
action, as more particularly described above. This assures a full
maximum stroke of the withdrawal pump and, as a consequence, even
with the heart skipping a beat, there is little, if any, change in
blood pressure level. By continuing to gradually increase the blood
pressure control level as the action of the ventricle continues to
recover, as by proper manipulation of power control knobs 12e and
16e, provision is made so that no more reliance is placed upon the
pumping system and apparatus than is necessitated by the
incapabilities of the left ventricle of the heart.
With the approach of the full natural heart action, that is,
natural action of the left ventricle, potentiometer 41c is set to
give a blood pressure of some 10 points below the normal blood
pressure of the patient. As the left ventricle, starting at some
very low pressure level, begins to develop an average pressure
which passes through the level noted and proceeds on to approach a
normal pressure, then the assistance afforded by our system and
apparatus is no longer needed.
e. In Absence of an Oscillographic Display
In those instances where an oscillographic display is not
available, the blood pressure of the patient may be determined
directly by the usual pressure cuff and stethoscope. If the patient
has a heart beat, even a weak one, our system and apparatus is
effective. The weak heart action will be reflected by some slight
pulsing of blood pump 18--28 and alternate lighting of pilot lights
10 and 11 (FIG. 8) connected across the supply to pump withdrawal
and discharge controls 12 and 16 respectively. And with this
indication, pulser 7 is then set to the same rate by first turning
off the pump power controls 12 and 16 (FIG. 7), leaving, however,
the remainder of the system energized, including the lights 10 and
11, and then setting pulser 7 at such rate as to agree with the
beat of the heart, that is, bringing the action of the pulser, as
observed by pilot lights 10 and 11, into synchronism with the beat
of the heart.
When pulser 7 is synchronized with the action of the heart, power
controls 12 and 16 are turned on by appropriate settings of control
knobs 12e and 16e respectively, and the pumping action begins. We
find that with appropriate setting of pulser 7, there appears to be
mechanical synchronization between the heart of the patient and
pump 18--40. A recovering left ventricle appears to lock into the
pump rhythm. A uniform, regular action is established.
As the left ventricle recovers, there is noticed an increase in the
blood pressure of the patient. This conveniently is determined by
temporarily stopping the pump, as by switching it off at 15, and
then switching it on again after the pressure has been determined,
or more properly in order to retain synchronism between pulser and
heart, by turning off the pump power supply of withdraw power and
discharge power by bringing dial pointers 12e and 16e to the zero
position and returning to desired operating position (FIG. 7).
Additionally, we find that with recovery of the left ventricle,
less pump power is required, this as reflected by the decreased
time in which the withdrawal stroke is accomplished and the longer
rest period following the discharge stroke. Actually, the blood
pressure of the patient may be determined at any time, even without
stopping the pump, by using pressure cuff and stethoscope, as noted
above.
f. In Absence of Electrocardiograph But With Auxiliary Control
The system and apparatus of our invention, including the alternate
automatic blood pressure controls described above, may be employed
even in absence of the electrocardiograph. More particularly, the
blood pressure detector 50 (FIG. 10), having expansible chamber
50a, is filled with a sterile saline solution by way of fill cap
hole 50b. A small plastic tube 51 is connected to valve 50c and a
hypodermic needle (not shown) is connected to the distal end of the
tube. Valve 50c is opened, the system is flushed with the saline
solution, and the valve then closed. The system is again filled
with the saline solution and fill cap 50b is replaced. The
equipment then is ready for application to the patient.
The hypodermic needle is inserted into any convenient artery of the
patient, and valve 50c again opened. As blood flows into the
detector, flow-restricting valve 50d is adjusted to allow only a
small flow. The blood pressure is registered on gauge 50e, this
recording any pressure from 0 to 300 millimeters of mercury. The
valve 50d, when properly adjusted, serves to average out the
systolic and diastolic pressures to give a mean or average
value.
As blood enters the detector, spring retained bellows 50f defining
the sidewalls of chamber 50a expands and increases the capacity of
the chamber. When the pressure in the chamber reaches the same
value as the average blood pressure of the patient, bellows 50f
reaches an ultimate position. In spite of the averaging of systolic
and diastolic pressures had with valve 50d, there nevertheless is
observed some slight pulsing of bellows 50f and gauge 50e. When the
ultimate position is reached, detector 50 is plugged into automatic
blood pressure amplifier 41, as by way of connections 52a and 52b
coming from potentiometer 52, forming a part of the blood pressure
detector equipment. Amplifier 41 is then plugged into out
ventricular pump system as at 49 (FIG. 8).
Now blood pressure detector 50 is a simple electromechanical
assembly that directly indicates the average blood pressure of the
patient on gauge 50e, as noted above. Moreover, the detector
provides a variable voltage signal to amplifier 41. Potentiometer
52 of the detector is adjusted and clamped on the holder 52c in use
when the potentiometer is initially set with arm 52d in the
horizontal position, as shown in FIG. 10. In this position the
blood pump of our system operates at about one-half capacity.
Where it is desired to raise the blood pressure, potentiometer 52
is physically elevated about one-fourth inch, this by loosening the
holding clamp 52e and resetting the same in elevated position.
There results a clockwise rotation of potentiometer arm 52d, which
through action of potentiometer 52, decreases the voltage from
direct current source 53 applied to the base of the double
rectifiers of withdrawal power control 12. This action serves to
allow full gate voltage on the withdrawal power control, causing
the same to put out full power and operate the blood pump at full
capacity.
Operation of the pump at full capacity, of course, raises the blood
pressure of the patient. And as this occurs, the increased blood
pressure further expands bellows 50f of detector 50. As a result,
potentiometer arm 52d is moved in counterclockwise direction,
gradually reaching a horizontal position. Potentiometer 52 then
increases voltage from direct current source 53 applied to the base
of the rectifiers of pump control 12, with resultant lowering of
power output of the control and consequent reduction of the
activity of the withdrawal phase of the pump. With such lessening
of pump action, the blood pressure of the patient decreases. And
with this decrease, bellows 50f contracts slightly and
potentiometer arm 52d slightly reduces the control voltage of the
potentiometer, causing an ultimate increase in the power supplied
the pump in manner more particularly described above.
Movement of bellows 50f either up or down, corresponding to an
increase or decrease in blood pressure, is mechanically transmitted
to control potentiometer 52, which in turn is reflected as a
decrease or an increase in the capacity of the blood pump as noted.
The system and apparatus soon reach a point where a balance is had
between the capacity of blood pump 18--28 and the blood pressure
detecting apparatus; the point is reached where just enough blood
is pumped to maintain a precise level of the detector apparatus.
This is recorded on pressure gauge 50e. In short, by positioning
potentiometer 52 either up or down on holder 52c, any desired blood
pressure can be automatically maintained.
Thus, in conclusion, it will be seen that we provide in our
invention a method, system and apparatus in which there are had the
various objects set out above, and the numerous practical
advantages thereof. Our system provides a simple, direct and
effective means for handling blood in quantity sufficient for
definitive results, and all with minimum untoward effect, that is,
a minimum of hemolysis, minimum conversion of fibrinogin to fibrin
threads, and the like.
The system and apparatus of our invention are particularly useful
in the treatment of congestive heart failure, and in those
instances where there is a temporary weakening of heart activity
resulting from postoperative shock, hemorrhage, infection, or
myocardial infarction with pump failure.
Since many changes and variations may be made in the method, system
and apparatus of our invention, it is to be understood that all
matter described herein, or shown in the accompanying drawings, is
to be interpreted as merely illustrative, and not by way of
limitation.
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