U.S. patent number 3,860,968 [Application Number 05/878,341] was granted by the patent office on 1975-01-21 for compact, implantable apparatus for pumping blood to sustain blood circulation in a living body.
Invention is credited to Max Shapiro.
United States Patent |
3,860,968 |
Shapiro |
January 21, 1975 |
COMPACT, IMPLANTABLE APPARATUS FOR PUMPING BLOOD TO SUSTAIN BLOOD
CIRCULATION IN A LIVING BODY
Abstract
An artificial heart system for implant is disclosed in which a
deflatable bladder provides a straight-through blood path. The
bladder is disposed in a gas filled chamber, the volume of which is
controlled by a piston in the immediate vicinity of the bladder to
provide pumping action. The piston is driven by a motor. A pressure
equalizing bypass as between chamber and atmospheric pressure, and
a check valve provide local autoregulation for the pump. A
pacemaker can be operated in synchronism with the drive to
simulate, for example, the natural right heart while the natural
left heart is deactivated or bypassed.
Inventors: |
Shapiro; Max (Beverly HIlls,
CA) |
Family
ID: |
25371830 |
Appl.
No.: |
05/878,341 |
Filed: |
November 20, 1969 |
Current U.S.
Class: |
623/3.22;
128/899; 417/384; 417/385 |
Current CPC
Class: |
A61M
60/40 (20210101); A61M 60/148 (20210101); A61M
2205/33 (20130101); A61M 60/268 (20210101); A61M
60/122 (20210101); A61M 2205/3303 (20130101); A61M
60/50 (20210101); A61M 60/562 (20210101) |
Current International
Class: |
A61M
1/10 (20060101); A61M 1/12 (20060101); A61f
001/24 () |
Field of
Search: |
;3/1,DIG.2
;128/1,214,DIG.3,273 ;417/383-390 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
"Problems of Artificial Hearts And Their Experimental Study," by B.
Y. Petrovsky et al. Journal of Thoracic and Cardiovascular Surgery,
Vol. 57, No. 3, March, 1969, pages 431-441..
|
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Frinks; Ronald L.
Attorney, Agent or Firm: Siegemund; Ralf H.
Claims
I claim:
1. In an artificial heart serving as a complete heart substitute,
or a bypass, or a relief, the combination comprising:
first means defining a pressure chamber filled with gas, having
aligned openings repectively on opposite sides, further including a
piston movable transverse to the direction of alignment of the
openings, for increasing volume, and decreasing pressure, and vice
versa, in the chamber;
a deformable bladder suspended in the chamber to be surrounded by
the gas in the chamber and having aligned inlet and outlet tubes,
respectively placed in the openings, thereby, closing the chamber
as to these openings, the inlet and outlet tubes provided for
respective connection to venous and/or arterial blood vessels;
second means connected to the first means, and serving as piston
chamber extension on the side of the piston opposite the side
thereof facing the pressure chamber, the second means defining a
second chamber filled with the same gas as the first chamber, there
being duct defining means to cause communication between first and
second chambers in a retracted position of the piston relative to
the first chamber;
motor means supported by the second means and providing a rotary
output;
third means linking the rotary output of the motor means to the
piston for imparting upon the piston a reciprocating motion;
and
valve means for opening and closing the flow path in the inlet and
outlet tubes anticyclically and in synchronism with the pressure
change in the pressure chamber and the bladder as controlled by the
piston.
2. In an artifical heart as set forth in claim 1, including means
for maintaining substantially constant pressure in the first
chamber during piston retraction.
3. In an artifical heart as set forth in claim 1, the piston being
a flat disk, there being guide posts on the piston, the first means
being a housing with bores receiving the posts to inhibit tilting
of the piston.
4. In an artifical heart as set forth in claim 1, there being
fourth means to maintain essentially atmospheric pressure in the
second chamber.
5. In an artificial heart as set forth in claim 4, the fourth means
including a duct leading from the second chamber to the outer
atmosphere.
6. In an artificial heart as set forth in claim 1, the means for
linking, including a harmonic drive to change the relatively fast
rotation of the motor means to a slow rotation commensurate with
the cycle of the piston.
7. In an artificial heart as set forth in claim 1, the valve means
including symmetrical shutter means operated by the piston for
squeezing and dilating the tubes of the bladder.
8. In an artificial heart serving as heart substitute, bypass or
relief, the combination comprising:
first means defining an enclosure and including wall portions
defining a piston chamber;
a piston in the piston chamber biparting the interior of the first
means to define first and second chambers respectively facing
opposite sides of the piston;
the enclosure being filled with compressible gas, the enclosure
having a pair of openings of the first chamber;
a deformable bladder disposed in the first chamber surrounded by
the gas therein and having inlet and outlet tubes respectively
passing through the openings of the pair, there being means to seal
the openings at the tubes;
relief valve means disposed between the first and the second
chamber to prevent the pressure in the first chamber to drop below
a particular value;
means in the enclosure defining bypass means interconnecting the
first and second chambers when the piston has position
corresponding to maximum volume of the first chamber, the second
chamber having the particular value of pressure at least during the
last phase of piston retraction to said position;
means coupled to the piston for imparting reciprocating motion upon
the piston; and
means for providing alternating constriction and dilation of the
tubes, anticyclically to each other, and in synchronism with the
piston reciprocation.
9. In an artificial heart serving as a complete heart substitute,
or a bypass, or a relief, the combination comprising:
first means defining a pressure chamber filled with gas, having
aligned openings respectively on opposite sides, further includng a
piston movable transverse to the direction of alignment of the
openings, for increasing volume, and decreasing pressure, and vice
versa, in the chamber;
a deformable bladder suspended in the chamber to be surrounded by
the gas in the chamber and having aligned inlet and outlet tubes,
respectively placed in the openings, thereby closing the chamber as
to these openings, the inlet and outlet tubes provided for
respective connection to venous and/or arterial blood vessels;
second means connected to the first means, and serving as piston
chamber extension on the side of the piston opposite the side
thereof facing the pressure chamber, the second means defining a
second chamber filled with the same gas as the first chamber;
motor means supported by the second means and providing a rotary
output;
third means linking the rotary output of the motor means to the
piston for imparting upon the piston a reciprocating motion;
valve means for opening and closing the flow path in the inlet and
outlet tubes anticyclically and in synchronism with the pressure
change in the pressure chamber and the bladder as controlled by the
piston; and
means for providing flow of gas between the first and the second
chamber during piston retraction corresponding to the diastole to
maintain the pressure in the first chamber essentially constant.
Description
The present invention relates to a pumping apparatus for pumping
blood through a living body so as to sustain blood circulation, and
more particularly, to improvements in the art of so-called
artificial hearts and heart bypass of relief pumps of compact
design, preferably for implantation.
The (natural) heart is a muscular organ establishing two pumps
which run in synchronism. The main pumping action of each pump is
provided by a chamber called the ventricle, whereby the so-called
right ventricle pumps blood into the pulmonary artery for passage
into the lungs to sustain the pulmonary circulation. The left
ventricle pumps blood into the aorta for profusions throughout the
body in order to sustain the so-called systemic circulation. The
venous return from the systemic circulation leads into an
antechamber for the right ventricle, called the right atrium, while
the venous return from the lungs lead to an antechamber for left
ventricle, called the left atrium. Blood flows from the atria into
the ventricles during the so-called diastolic cycle; the blood is
compressed in the ventricle, and discharged into the respective
arteries during the systolic cycle.
In order to sustain the systemic circulation, the left ventricle
has to raise the blood pressure from approximately atmospheric
pressure of the venous return from the pulmonary system by about
120 to 150 mm/mercury, or thereabouts. The principal function of a
cardiac prosthesis, permanent as well as temporary, is to provide
such pumping action at a characteristic which is at least
approximately a faithful simulation of normal heart action and can
be maintained, in principle, for an unlimited period of time.
Simulating the pumping action can thus be regarded as synthesizing
the natural alternating diastolic and systolic cycles. The
invention relates to a pumping system which provides distinct
diastolic and systolic cycles as created by the natural heart.
The pumping operation of a natural heart has been described by
so-called Starling's law, according to which the heart pumps all
the blood that comes to its without allowing excessive damming of
the blood in the veins, of course, within physiological limits. In
other words, the heart adjusts its action to the demand. The
invention relates to a pumping system which obeys Starling's
law.
Aside from mechanical duplication of the pump and duplication of
control actions, a cardiac prosthesis must handle blood flow in an
atraumic manner without damaging it. The blood must not stagnate
nor incur turbulence, nor must clots be formed and hemolysis has to
be avoided. In accordance with the present invention, the following
combination is suggested.
A first chamber is provided, serving as pressure chamber and
containing an inert gas; air was found to be suitable but nitrogen
or some other gas with large molecules (low diffusion rate) may be
better. The interior of the chamber is to a considerable extent,
occupied by an inflatable and deflatable bladder made of durable,
flexible and expandable, rubbery material, or the like. The gas in
the chamber does not fill the bladder. The bladder is of elongated
construction and has aligned inlet and outlet tubes integral
therewith. These tubes are affixed to a pair of aligned openings in
the first chamber and close the openings as far as the interior of
the chamber external to the bladder is concerned. Inlet and outlet
tubes are respectively connected in the blood path, for example,
leading from a vein to an artery. Thus, blood can flow into,
through and out of the bladder in an essentially straight through
flow path.
The bladder is surrounded by the gas and pressure as well as volume
off the bladder is determined by gas pressure acting essentially in
direction perpendicular to the bladder surface. Blood flows through
the bladder in what can be regarded an axial direction of tube and
opening alignment as defined. The bladder inflates and deflates,
therefore, essentially radially.
One of the walls closing the chamber parallel to that axial
direction is movable toward and away from the bladder and serves as
a piston. Adjacent walls of the chamber are extended so that the
first chamber is, in part, a piston chamber, but there is a second
chamber on the other side of the piston. The second chamber is
filled with the same gas as the first chamber and may be maintained
at a pressure not dropping below atmospheric pressure.
The second chamber includes short piston linkage translating rotary
motion into a reciprocating motion. The rotary motion is provided
by a motor disposed adjacent the second chamber and transmitted
preferably by a so-called harmonic drive-type converting relatively
fast rotation of the motor into slow motion corresponding to a rate
for reciprocation in the order of 100cpm. The reciprocating motion
imparted upon the piston establishes alternating systole and
diastole respectively as compression/arteric discharge and
controlled intake cycles.
Assuming the bladder has been filled, a valve in the path of the
inlet tube closes, and the piston is moved forward to compress the
gas in the first chamber, thereby causing the blood therein to be
pressurized. As the gas used is compressible, the blood compression
is a gentle one. Shortly thereafter a valve in the outlet tube and
leading, for example, to the aorta, opens, and the blood begins to
discharge from the bladder into that artery. The valve is opened
when pressure is high enough so that systolic pressure can be built
up in the artery. The valve remains open for the length of time
necessary to generate a proper pulse wave having duration, for
example, of 1/4 pulse cycle as in the human heart.
As the piston continues to move toward further compression of the
gas in the first chamber, blood is pushed out of the bladder at the
arterial systolic pressure until discharged. The first chamber is
dimensioned so that for an almost fully protracted piston, gas
pressure is above arterial pressure to prevent back-flow of
blood.
Shortly before the piston begins to retract, the valve governing
the outlet tube in the artery closes. In timed relation thereafter,
the inlet valve reopens, particularly when the piston has retracted
to such a degree that the gas pressure in the first chamber has
dropped to the venous pressure which is about atmospheric pressure.
In essence, the retraction of the piston is controlled in such a
manner that the volume increase in the first chamber equals the
expansion of the bladder as blood flows in under venous pressure.
It is essential that the piston generates a slight pressure drop in
the expanding first chamber relative to the atrial pressure, but
the pressure drop must not be strong enough to produce collapse of
the veins; this is most critical for successful operation of the
device.
The venous return versus atrial pressure of a natural heart, has a
negatively sloping characteristic with zero return at about 7 mm Hg
positive. Flow increases with decreasing pressure but leveling-off
begins at a few mm Hg negative. A further negative increase of
atrial pressure does not increase and may decrease the venous
return. The piston retraction must thus produce and maintain a
pressure in the first chamber below a positive pressure amounting
to an actual damming of the blood, but above a negative pressure
corresponding to the leveling off point of the atrial
pressure-venous return characteristics in order to prevent venous
collapse. Atmospheric pressure equivalent to zero pressure on the
commonly used scale is a very suitable value, so that the first
chamber can be brought into communication with the second chamber
by a check valve, for example, in the piston, as soon as pressure
in the first chamber drops to atmospheric pressure.
The piston thus merely increases the volume of the first chamber so
that the bladder can expand as blood from the vein enters without
having to work, and without actually being sucked in, i.e., the
piston's movement provides the expansion of the bladder so that the
venous return blood just flows into the expanding bladder at
minimum resistance without being actually sucked in by a vacuum
system.
The inlet valve closes at about the time of maximum piston
retraction, and just after that time the pressure between the two
sides of the piston equalizes, independently from operation of the
check valve. Check valve and pressure equalization at the end of a
cycle is instrumental in causing the system to obey Starling's law.
Moreover, the pressure equalization between the chambers at one
point during each cycle is essential for long term operation as the
gas must not accumulate on one side or the other of the piston,
particularly the compression of the first chamber should always
begin from about atmospheric pressure at closed valves.
As the system is designed for a particular maximum capacity of the
stroke, which should be above the mean value, the venous return
flow may come to a stop prior to complete retraction. However, the
pressure-sensitive valve maintains equality of pressure on both
sides of the piston so that the first chamber cannot develop
negative pressure after blood in-flow has ceased but prior to
complete piston retraction.
The inventive system, if used as suggested, operates by bypass or
as substitute for ventricle. Heart damage often involves the left
ventricle only as the main pumping organ, while the right ventricle
serving the pulmonary system is less likely in need of replacement.
A pump as described can serve as substitute or replacement of the
left ventricle which has been deactivated. It is thus suggested to
include a pacemaker into the system and to drive the pacemaker in
synchronism with the pump, so that the remaining right ventricle of
the natural heart is forced to pump in synchronism with the
mechanical pump as described and which has taken over the function
of the left ventricle. Alternatively, a second bladder can be
inserted, so that a substitute is present for both, left and right
heart, operating in harmonie with each other; this will be subject
of a separate application for patent.
The valves involved in the control of bladder intake and outflow
are preferably operated in response to piston operation, but may be
operated by other mechanical or electromechanical means. The valves
are actively controlled which permits control of the slope of the
pressure pulse at the outlet since there is quite a definite
relationship between piston position and gas pressure in the first
chamber. Thus, the blood flow does not have to be controlled by
pressure responsive valves which are included in the blood path,
and the installation of flow impediments in the blood path can be
avoided, preventing turbulence clotting and other blood damage.
The valve at the outlet tube of the bladder is opened when the
piston has a position corresponding to a particular relative volume
reduction in the first chamber which corresponds to a particular
pressure increase therein, somewhat in excess of the aortic
pressure. This holds true because a particular volume of the gas is
compressed always by a particular relative volume reduction, and
since the device is always at a constant body temperature, there is
a definite relation between piston position and pressure in the
first chamber (Boyle's law). The valve governing the outlet tube
can thus be opened in dependence upon position of the piston
indeed.
One can readily see that employment of a compressible fluid is
essential for a smooth and sufficiently elastic operation. The
aortic valve of the output side of the bladder is closed just prior
to maximum protraction of the returning piston. Again, piston
position response can be used as controlling factor, as the blood
will not flow back into the bladder as long as the piston moves
toward further compression. The inlet valve opens during retraction
of the piston when the pressure in the pressure chamber has almost
reached atmospheric pressure. Again, this can be made dependent
upon the position of the piston as there is a definite relationship
between pressure and volume, particularly for completely empty
bladder. The inlet valve should remain open until the piston is
completely retracted.
It should be noted that an asymmetry could be included in the
piston operation in that its protracting phase is shorter than its
retracting phase, which feature makes the pump particularly
comparable with the rather long diastole and relatively short
systole as is the case of the natural heart.
The system can be designed to operate normally at less than full
capacity so that the pump provides the equivalent of the
heterometric autoregulation which is one of the intrinsic
mechanisms for adapting the natural heart to a variable venous
return. As the driving motor can be provided to operate at a
constant speed characteristic for a chosen range of torque, the
pump has also the equivalent of homeometric autoregulation.
Measuring the venous return pressure and controlling the motor in
pumping speed can be used to provide the equivalent of the
intrinsic autoregulation. All these various features together cause
the artifical device to obey Starling's law.
While the specification concludes with claims particularly pointing
out and distinctly claiming the subject matter which is regarded as
the invention, it is believed that the invention, the objects and
features of the invention and further objects, features, and
advantages thereof will be better understood from the following
description taken in connection with the accompanying drawings in
which:
FIG. 1 illustrates schematically a system for operation as a left
heart substitute;
FIGS. 2 and 3 are longitudinal section views through a heart
prosthesis incorporating the principles of the invention in
accordance with the preferred embodiment thereof; and
FIGS. 4 and 5 are longitudinal section views of the structure shown
in FIGS. 2 and 3 and as indicated therein.
Proceeding now to the detailed description of the drawings, in FIG.
1 thereof there is illustrated a system in accordance with the
preferred embodiment for practicing the invention and which
includes a prototype that has been successfully employed in animal
experiments. The system includes a pump P with a housing 10, having
a gas filled pressure chamber 12, the volume of which and the
pressure therein being under control of a piston 15 reciprocating
by operation of linkage, which in return is driven by a motive unit
60.
A bladder 20 in chamber 12 is provided as artificial ventricle. In
the conducted experiment, the bladder was interposed in the
arterial circulation, between the left atrium and the descending
aorta. The left ventricle was deactivated with a balloon catheter,
closing the AV valve as well as the aortic valve, thus providing
straight-through flow from the left atrium through the bladder 20
to the descending aorta.
Thus far the description relates to a system as it has been
actually used to sustain blood circulation in a dog. It was found,
that the heart as a whole was not deactivated to the extent that
the pulmonary circulation could not be sustained, instead the right
heart continued to function. As a backup, the following auxiliary
equipment was planned. A pick-off unit PO responds to the phase of
the pump P to drive a so-called pacemaker PM stimulating the
natural right heart RH in synchronism with the operation of pump P.
The pacemaker is normally an automonous electronic oscillator,
however, such oscillator can always be forced into synchronism with
a master frequency which, in this system, is derived from the
motive unit 60 by pick-off PO. The pacemaker PM provides electrical
stimulating pulses in synchronism with its oscillations. The system
can be supplemented, for control, by a pressure transducer T on the
input side of bladder 20 to monitor what is, in effect, the venous
return pressure to govern a control circuit CC interposed between a
power supply PS and the motive unit 60. In the experiment
conducted, motive unit 60 was directly coupled to the power supply
unit PS comprised of batteries.
Turning now to the description of FIG. 2, et sq., the pump includes
the housing 10 which basically defines two chambers along an axis
11. One of the two chambers has been referred to repeatedly in the
specification as the first or pressure chamber and is denoted by
reference numeral 12. The second chamber 13 is separated from
chamber 12 by the movable piston 15, the piston being particularly
movable along axis 11 in reciprocating motion, thereby
alternatingly decreasing and increasing the volume of pressure
chamber 12, while concurrently increasing and decreasing the volume
of chamber 13. The forward or compression stroke or cycle refers to
a decrease in volume of chamber 12 by protraction of piston 15 and
a concurrent increase in volume of chamber 13. Correspondingly, a
decompression or suction stroke or cycle refers to enlargement of
chamber 12 during retraction of piston 15.
The decrease or the increase in volume in chamber 13 does not
necessarily infer corresponding pressure change in chamber 13,
since chamber 13 may communicate with the exterior to maintain at
least approximately atmospheric pressure. On the other hand, the
pressure in chamber 12 varies definitely with reciprocation of
piston 15.
Housing 10 is provided either for an implant in total, or in part,
and it is essential that it is of compact design to support all
elements needed to provide, in effect, an alternating sequence of
systoles and diastoles. Chamber 12 is occupied to a considerable
extent by bladder 20. Bladder 20 is provided with an inlet tube 21
and an outlet tube 22. The two tubes 21 and 22 are aligned in
undeformed configuration of the bladder, which is positioned in
chamber 12 at an orientation so that the aligned tubes 21 and 22
extend transverse to axis 11.
Wall portions of housing 10 defining the particular chamber 12 have
two essentially, registering openings 31 and 32. The inlet and
outlet tubes 21 and 22, respectively, traverse these openings and
are centrally positioned therein. Accordingly, the two openings 31
and 32 are coaxial and transverse to axis 11. The openings 31 and
32 are covered to some extent by coverplates 33 and 34 having short
tubes 35 and 36, respectively. The tubes 21 and 22 are respectively
received by tubes 35 and 36. The ends of tubes 21 and 22 are turned
back and surgical connection tubes 37 and 38 are tightened thereto.
Tube 37 is surgically affixed to a blood vessel to receive the
blood flowing toward the heart in one of the venous return paths.
Tube 38 is connected to the aorta.
As can be seen from the drawings, bladder 20, with inlet and outlet
tubes provides a straight-through flow path of blood when flowing
from the venous return to the aorta, bypassing the left heart or
flowing through without being pumped.
The bladder 20 is surrounded by the gas which fills that portion of
chamber 12 not occupied by the bladder. This gas can be regular
air. However, nitrogen, as an inert gas or a gas with large
molecules to prevent loss through the bladder is preferred. Seals
23 and 24 respectively seal the apertures 31 and 32 where the tubes
21 and 22 pass through to seal the interior of chamber 12. As the
gas pressure is increased, the bladder is radially contracted with
reference to the axis of the flow path of blood through the
bladder. Relaxation of pressure in chamber 12 may result in bladder
expansion.
The pressure in chamber 12 is controlled by piston 15, moving up to
the immediate vicinity of the bladder during compression of gas in
chamber 12. It is an important aspect of the construction that axis
11, along which the piston moves to and from the bladder, is
transversely disposed in relation to and intersects the axis of
blood flow. The reason for this lies in the following. For reasons
of space, chamber 12 should be kept as small as possible and the
piston should have relatively large surface so that the stroke
length of the piston can be small. The volume of the bladder is an
operating parameter and the change in volume of chamber 12 during
each stroke is always equal to the volume of the fully expanded
bladder. A symmetric disposition of the axes with respect to each
other optimizes the construction for the given parameters.
The total amount of gas compressed is not very large, and the
compressibility thereof is a material factor for smooth operation.
Moreover, in spite of short piston stroke length, the pressure in
chamber 12, as developed by a compressible medium in the vicinity
of bladder, can still be very accurately controlled by operation of
the position of piston 15.
Inflow and outflow of blood in relation to bladder 20 is controlled
by operation of a pair of valves 40 and 50. The inlet valve 40 is
comprised of a pair of shutter blades 41 and 42 running in a recess
101 on one side of housing 10, symmetrically disposed to opening
31. The two shutters 41 and 42 move in unison toward or away from
each other along an axis which is transverse to both axis 11 and
the axis of blood flow. The shutter blades may have a fairly wide
section at the end nearest the inlet tube.
The shutter or valve blades 41 and 42, when moving toward each
other, squeeze inlet tube 21 and constrict the passageway
therethrough. The valve is regarded as closed when the shutters
have squeezed opposite wall portions of tube 21 against each other
so that the cross section of the flow path through the tube is, in
effect, reduced to zero. When the shutters move away from each
other, tube 21 dilates and blood flows through the tube
uninhibited. As to outlet tube 22, there is a pair of shutter
blades 51, 52 for valve 50 running in a recess 102 and operating
similar to valve 40. However, the timing of operation of the two
valves differs.
The details of an advantageous actuating mechanism for the valve
shutters is part of a separate patent application. Briefly, the
piston 15 is provided with actuator rods 151, 152, 153 and 154
extending into the interior of chamber 12. The rods 151 to 154 are
provided with cams for reasons of timing the valve opening and
closing and act on spring-biased linkage levers which in turn
operate the valve shutters 41, 42, 51 and 52; shutters 41 and 42
are operated in unison and in dependence upon the position of the
piston. Shutters 51 and 52 are also operated in unison but
essentially anticyclically to the timing of operation of shutters
41 and 42.
The valves operate as controllable constrictions of smooth contour,
particularly during periods of respective valve opening or closing
operation as the respective shutter blades approach or recede. The
valve operates without generation of turbulence, nor do they create
regions of stagnation, since valve shutter blades are not
positioned directly in the flow path of the blood. The closed
position of the valve is positively maintained through the shutters
external to the flow path proper.
Rods 152 and 154 act in unison and respectively operate linkage to
cause the shutter blades 41 and 42 to open the passage through
inlet tube 21 during most of the suction phase of piston 15,
closing the passage shortly before the beginning of the compression
phase and keeping the passage closed throughout compression. Rods
151 and 152 cause blades 51 and 52 to open outlet tube 22 during
compression phase but only after piston 15 has decreased the volume
of chamber 12 to such an extent that the pressure has risen
somewhat above the systolic pressure in the aorta. Tube 22 is then
opened and remains open throughout the remainder of the compression
phase. Valves 40 and 50 are never open concurrently, but there are
brief phases when they are both closed, particularly after
completion of discharge of the bladder.
Chamber 13, on the other side of piston 15, is provided with a
separate housing which is still part of housing 10 and contains the
motor unit 60. The motive unit 60 includes a d-c motor 61 having
its rotary output coupled to a harmonic drive 62. The drive 62 is
actually a transmission which converts the relative fast rotating
motion of motor 61 to a slow rotary motion about the same axis. The
outstanding characteristics of the harmonic drive is that
essentially by operation of two, three or more rotating gear
elements, a speed reduction of 100:1 and more is obtainable. In
conventional gears, meshing gear wheels engage in that tooth-flanks
slide on each other. The gears involved in a harmonic drive do not
revolve on each other in frictional contact as between engaging
teeth; instead, the teeth of the driving member of a harmonic drive
move to and from teeth of the driven member thereof in directions
normal to the respective surface about to engage and after
engagement with little or no relative motion during engagement.
There is very little frictional contact between the several teeth
as teeth flanks move hardly at all tangentially relative to each
other when in contact. The harmonic drive is a very compact and
very low-wear transmission, and was found highly suitable for the
present purpose.
The output side of harmonic drive 62 provided with an eccentrically
located pin 63 linked to an element which can be described as a
piston rod 65. A pivot pin 66 links piston 15 to piston rod 65. A
balancing shaft 67 is journaled in a bearing block 68 and carries a
disk 69 receiving pin 63 to relieve the drive system from
cantilever action. Shaft 67 is coaxial to the output axis of
harmonic drive 62.
The revolving motion of pin 63 about the common axis of drive 62
and of shaft 67 is translated into a reciprocating motion of piston
rod 65 and piston 15. The stroke length is determined by the two
possible extreme positions of pin 63 along axis 11. FIGS. 2 and 3
show the fully retracted position of the piston at the end of the
diastole and the beginning of the systole.
The simple linkage provided by the pin-rod arrangement 63-65
establishes similar suction and compression cycles as the piston
position vs time follows a sinusoidal characteristic. As an example
of one method to extend the diastole and to shorten the systole, a
slotted mask can be interposed forcing pin 63 to run in a slot. Pin
63 can be made radially movable where journaled to the rotary
output member of the harmonic drive. A cam slot for guiding pin 63
can be contoured so that the timing between extreme piston
positions differ, suction to last longer than compression. The cam
slot additionally can be contoured so as to simulate closely the
natural inflow rate of blood from the venous return path. This way
piston motion alone establishes pressure in chamber 12 throughout
the suction cycle, for an even flow of blood into the bladder.
As particularly illustrated in FIG. 3, housing 10 is provided with
an indentation 14 serving as a bypass, controlled leakage path, or
communication duct between chambers 12 and 13 to become effective
when the piston is in or very near the completely retracted
position. Atmospheric pressure can be established and maintained in
chamber 13, for example, through a duct leading to the exterior of
the body in which the unit is implanted; this was the case in the
unit actually tested. Alternatively, the unit can be sealed after
an internal pressure at or near atmospheric pressure has been
established in both chambers. In this case a gas other than air can
be used. Pressure balance at or near atmospheric pressure is
positively established in both chambers upon maximum retraction of
the piston, toward the end of each simulated diastole through duct
14.
A check valve 70 in piston plate 15 ensures, on the other hand,
that the pressure in chamber 12 is never allowed to fall below
atmospheric or near atmospheric pressure maintained or existing in
chamber 13. Check valve 70 and bypass 14 are instrumental in the
autoregulation of the pump to meet variable demands resulting from
variations in the venous return. If chamber 13 is sealed, it may
have an expandible wall so that pressure therein remains
essentially constant during piston motion. The wall will expand
into the body cavity. In the alternative one can provide an
auxiliary bubble communicating with chamber 12, serving as variable
reservoir and expanding into the body cavity.
It can readily be seen that in particular, during the diastole,
when piston 15 retracts, the volume of chamber 12 not occupied by
bladder 20 remains essentially the same with the pressure being
near atmospheric level. The bladder is thus forced to expand. As
the tube 21 dilates shortly after piston retraction has begun,
blood from the venous return is permitted to enter through tube 21
at the rate of expansion. The blood is thus positively pulled into
the bladder, indirectly by the piston, without involving gas flow
into or out of chamber 12. The gas serves merely as a resilient
linkage as between piston and bladder. Only when the inflow of
blood into the expanding bladder tends to drop, valve 70 will open
to provide, so to speak slack to the "linkage."
During the systole, the gas serves as a gentle compressure medium
for the blood in the bladder. Soon after beginning of a compression
cycle, tube 22 dilates by opening of blades 51-52 and blood is
pushed out of the bladder into the aorta, the pushing being
provided actually by the piston with the expanding gas serving
again as elastic linkage. The pressure in chamber 12 drops to the
value of the aortic pressure to maintain equilibrium. As piston 15
moves still towards further reduction of the volume of chamber 12,
blood is pushed out of the bladder but cannot flow back. Shortly
before piston retraction begins, valve 50 closes.
As was briefly alluded to above, it can be shown that the pump
synthetizes all of the intrinsic mechanism employed by the natural
heart for adapting the pumping power to the demand as represented
by the amount of the venous return. The volume of bladder 20 can be
selected to have dimensions that, for the normal rate of venous
return, the bladder is not completely inflated by one stroke.
Moreover, the change in volume of chamber 12 by operation of piston
15 should be somewhat larger than the volume of normal venous
return. This way a reserve volume capacity is available in bladder
20, as well as in chamber 12, for cases of a higher than normal
return.
Assuming that at an instant the venous return has dropped below the
amount returned during a previous stroke, cavity 12 will tend to
develop negative pressure as the blood flow into bladder 20 will
decline while the retracting piston still expands chamber 12 but at
a higher rate than the volume of the inflating bladder increases.
Accordingly, valve 70 will open to prevent negative pressure from
developing in chamber 12 while the piston still retracts. This,
however, increases the amount of gas in chamber 12. During the next
compression stroke there is produced the same absolute volume
reduction of chamber 12 but acting on a larger volume of gas while
the bladder is filled less. Compression always begins from
atmospheric pressure so that the relative pressure increase is less
than before, commensurate with a slightly reduced aortic pressure.
During the next diastole-retraction of the piston and assuming the
venous return remains at the previous reduced level, valve 70 will
not respond as the pressure in chamber 12 will reach atmospheric
level only at the point of complete retraction, i.e., by the time
piston 15 has reached bypass 14. It follows that as long as the
venous return does not change, valve 70 will not open but pressure
in chamber 12 will tend to drop below atmospheric pressure at about
the time piston 15 has reached bypass 14.
Should the venous return suddenly increase, atmospheric pressure in
chamber 12 may not have been reached by the time piston 15 has
completely retracted as there is too much gas in chamber 12. As
piston 15 reaches bypass 14 that excess gas will discharge from
chamber 12 by the pressure equalization process. It is thus
advisable to adjust the system so that inlet valve 40 (shutters 41,
42) closes only after pressure equalization between chamber 12 and
13 through bypass 14 to fill bladder 20 with at least most of the
venous return during this diastole about to be completed. During
the next cycle the gas volume in chamber 12 is reduced, permitting
bladder 20 to fill more. This may continue during several strokes
until a quantity of gas is removed from chamber 12 equivalent to
the increase in volume of the venous return.
It follows that the system always regulates itself toward a
condition so that the valve 70 is just about to respond to a
pressure drop by the time piston 15 reaches bypass 14. Thus, the
relative change in volume of expandable bladder and the change in
gas in chamber 12 operates as an inherent adaptation of the
geometry to variations in the venous return. As one can see,
therefore, operation of the pump has an intrinsic mechanism which
is the equivalent of the heterometric autoregulation of the natural
heart.
In case of employing a sealed system either chamber 12 or chamber
13 must be variable in volume, independently from piston operation.
In case chamber 13 is made variable, the situation is directly
analogous to a chamber open to the outer atmosphere. The walls of
chambers 13, or a portion thereof can be made expandable into the
body cavity. As the body has atmospheric pressure internally
essentially the same pressure is maintained in chamber 13 by
operation of wall flexing and expansion. The autoregulation
outlined above will thus function analogously, as atmospheric
pressure is maintained in chamber 13 throughout a piston cycle now
by external pressure effective through the expandable wall, the
decisive difference, of course, being that a closed gas system,
without communication to the extension permits utilization of a gas
other than air.
In lieu of or in addition to expandable walls for chamber 13,
chamber 12 may be provided with variable volume. This can be
obtained, for example, by placing the unit P or a portion thereof
in a closed but expandable sack communicating with chamber 12. The
expansion of that sack varies in unison with expansion of bladder
20. If little blood is sucked in, the sack inflates only slightly,
if much blood is sucked in, the sack inflates more. In this case,
neither valve 70 nor bypass 14 are required for autoregulation, but
bypass 14 is still needed to prevent unidirectional leakage between
the chambers.
In the latter case, chamber 12 being provided with a variable
volume extension, the pressure in the sack can be above atmospheric
pressure and actually varies in a range between about atmospheric
pressure and maximum pressure in chamber 12, above atmospheric
pressure for fully protracted piston which, of course, is above
"body pressure." In the first case, chamber 13 having expandable
wall, the chamber has maximum pressure for fully retracted piston,
but this is at atmospheric pressure. As the piston moves forward,
pressure in chamber 13 tends to fall except that atmospheric body
pressure causes wall contraction to the effect that the volume and
pressure of chamber 13 remain about constant. A closed system is
subject of a separate patent application.
Turning back to the description of the drawing, motor 61 should
have a constant speed vs. torque characteristics within the
operating range. It does not change speed if more power is demanded
for reasons of an increased demand in pumping power, instead, the
motor will consume more power which is analogous to a metabolic
change. Thus, the system automatically assumed the function of the
homeometric autoregulation as provided by the natural heart.
It follows from the foregoing that the heart prothesis, relief or
bypass device as described, obeys Starling's law. The so-called
intrinsic autoregulation of the natural heart can be provided by
speed control of motor 61 as was outlined above with reference to
FIG. 1 in response to pressure in or near tube 21.
In lieu of pressure controlling the communication between chambers
12 and 13 by operation of valve 70, a pressure transducer in the
chamber 12 could be provided in order to provide speed control of
motor 61, so as to slow down the piston when the pressure in
chamber 12 tends to drop too low a value or to speed up if the
demand so requires. Here, then, the heart rate is the predominantly
controlled factor for adapting the pumping power to the venous
return at all times.
A combination of the two controls is probably the best solution
particularly for reasons of choosing as small dimensions as
possible. The system normally may operate with a complete filling
of the bladder for each stroke. In case the venous return falls or
increases, the heart rate is respectively decreased or increased by
decreasing or increasing the speed of motor 61. Check valve 70
responds to emergencies only and there is always pressure
equalization between chambers 12 and 13 at the end of a stroke when
the piston is completely retracted, particularly in order to
prevent, as outlined above, accumulation of gas on one side of the
pumping system.
The invention is not limited to the embodiments described above,
but all changes and modifications thereof not constituting
departures from the spirit and scope of the invention are intended
to be included.
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