U.S. patent number 3,604,016 [Application Number 04/797,068] was granted by the patent office on 1971-09-14 for multiple function blood coupler.
This patent grant is currently assigned to Thermo Electron Corporation. Invention is credited to Fred N. Huffman, Thomas C. Robinson.
United States Patent |
3,604,016 |
Robinson , et al. |
September 14, 1971 |
MULTIPLE FUNCTION BLOOD COUPLER
Abstract
An integrated blood coupler for a totally implantable
heart-assist circulatory support system incorporating a
diaphragm-type blood pump adapted to be connected between the left
ventricle and aorta of the host, in which the pumping energy for
the assist pump is produced by an implantable power supply that
inherently produces waste heat as a byproduct, wherein the waste
heat is discharged to the blood stream through the diaphragm of the
blood pump, and in which the diaphragm serves as the physiological
sensor for producing pressure signals to synchronize the assist
system with the circulatory system of the host.
Inventors: |
Robinson; Thomas C. (West
Newton, MA), Huffman; Fred N. (Sudbury, MA) |
Assignee: |
Thermo Electron Corporation
(Waltham, MA)
|
Family
ID: |
25169807 |
Appl.
No.: |
04/797,068 |
Filed: |
February 6, 1969 |
Current U.S.
Class: |
623/3.21;
623/3.27; 417/394 |
Current CPC
Class: |
A61M
60/435 (20210101); A61M 60/40 (20210101); F04B
43/107 (20130101); F04B 9/107 (20130101); A61M
60/148 (20210101); F01L 25/066 (20130101); A61M
60/268 (20210101); A61M 60/894 (20210101) |
Current International
Class: |
A61M
1/10 (20060101); F01L 25/06 (20060101); F04B
9/00 (20060101); F04B 9/107 (20060101); F04B
43/107 (20060101); F01L 25/00 (20060101); F04B
43/00 (20060101); A61M 1/12 (20060101); A61f
001/24 () |
Field of
Search: |
;3/1,1AH ;128/1,DIG.3
;60/24,25 ;103/152,44D ;417/394 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
Final Report: Summary and Conclusions, Artificial Heart Program,
The Children's Hospital Medical Center, Boston, Mass., Thermo
Electron Engineering Corp., Waltham, Mass. Submitted to National
Heart Institute, Bethesda, Md., March 1966, pp. 25-35 (Copy
available in Group 335)..
|
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Frinks; Ronald L.
Claims
Having thus described our invention, what we claim is:
1. A blood coupler for a heart-assist circulatory support system
comprising power supply means for producing from a supply of
hydraulic pumping fluid at a first temperature and a first pressure
a supply of hydraulic fluid at a second higher temperature and a
second higher pressure, a blood pump comprising a thin resilient
expansible bladder sealed in a housing between openings adapted to
be connected in a blood circulation system, said openings being
provided with check valves to produce a pulsing unidirectional flow
of blood through said bladder when hydraulic fluid is forced in and
out of said housing outside of said bladder, and fluid exchange
means connected between said housing and said power supply by a
supply line containing pumping fluid at said first temperature and
pressure and a return line containing pumping fluid at said second
temperature and pressure, said fluid exchange means comprising an
inlet chamber, an outlet chamber, a communicating passage between
said inlet chamber and said outlet chamber, and thermally
conductive piston means movable in said communicating passage to
vary the volume of said inlet chamber with respect to the volume of
said outlet chamber, means connecting said outlet chamber to said
housing to exchange hydraulic fluid with said pump, means
responsive to a drop in pressure in said bladder for connecting
said supply line to said inlet chamber to admit a slug of fluid to
said inlet chamber, thereby moving said piston means to drive fluid
into said pump to compress said bladder while cooling the fluid in
the inlet chamber and heating the fluid in the outlet chamber,
while cooling the fluid in the housing and heating blood in the
bladder, and means responsive to the volume of said outlet chamber
for connecting said inlet chamber to said return line and
disconnecting said supply line when said outlet chamber reaches a
predetermined minimum volume.
2. The apparatus of claim 1, in which said means connecting said
outlet chamber to said housing comprises an expansible chamber
forming a closed and sealed container of constant volume with the
space in said housing and outside of said bladder, said constant
volume container being filled with hydraulic fluid.
3. A blood coupler for a heart-assist circulatory support system,
comprising an implantable blood pump comprising a housing, a thin
resilient bladder mounted in said housing and having a pair of
openings adapted to be connected for unidirectional blood flow in a
mammalian circulatory system, power supply means for producing from
a supply of fluid at a predetermined low temperature and pressure a
supply of fluid at high temperature and pressure, and fluid motor
means connected to said housing by a fluid exchange passage and
connected to said power supply by a supply line of fluid at said
high temperature and pressure and a return line of fluid at said
low temperature and pressure, said fluid motor means comprising
means energized by the difference in pressure between said supply
and return lines to supply pumping fluid at one temperature and
pressure to said housing to compress said bladder and transfer heat
through said bladder to blood in said bladder and to return cooled
fluid at said low temperature and pressure to said return line.
4. The blood coupler of claim 3, in which said fluid exchange
passage comprises an expansible chamber connected to and forming
with the space in said housing outside of said bladder a sealed
container of constant volume, and a fixed charge of hydraulic fluid
filling said sealed container.
Description
Our invention relates to prosthetic devices, and particularly to a
novel integrated blood coupler for exchanging heat and mechanical
energy with the blood in a heart-assist circulatory system that is
totally implantable.
Many traumatic or pathological cardiac conditions can be corrected,
or at least compensated for, by providing a pump to supplement the
action of the natural heart and assist in maintaining normal blood
circulation. One form of heart-assist system that has been proposed
comprises a diaphragm-type pump adapted to be implanted in the
thoracic cavity and connected between the left ventricle and the
descending aorta. The left ventricle is chosen because it performs
approximately 83 percent of the work done by the heart on the blood
stream.
In order to operate the pump, it has been proposed to supply it
with pneumatic or hydraulic energy through transcutaneous
connections to an external fluid supply. To synchronize the supply
of fluid under pressure to the pump with the natural circulatory
system, it has been proposed to connect electrodes to the host to
pick up the electrical signals produced by the physiological motor
control system. Obviously, while quite useful in many respects,
such a system greatly restricts the mobility of the host. And it is
impractical to maintain transcutaneous connections to the implanted
pump for long periods of time, because of the risk of infection.
Accordingly, it would be highly desirable to have a circulatory
support system that could be totally implanted in the body of the
host and which could be left to function for relatively long
periods of time without the need for continual surgical
interference. The implantation of such an assist system does not
present any insurmountable surgical or prosthetic difficulties in
the present state of the medical arts, except that the size and
weight of the apparatus is necessarily limited by the space
available in the body for implantation without the excision of
useful tissue. The apparatus necessarily requires a power supply
capable of supplying pumping energy to the pump over a relatively
long period of time, and preferably for several years, without
regeneration. Control apparatus is required to synchronize the pump
with the natural circulatory system. In the operation of the
system, waste heat is inherently generated, and it is necessary to
dissipate that heat without injury to the body of the host. It is
the object of our invention to facilitate the exchange of heat and
mechanical energy with an implanted blood pump without
transcutaneous connections to external apparatus.
Briefly, the above and other objects of our invention are attained
by a novel blood coupler comprising a modified left ventricular
assist pump in which the diaphragm is made of thin flexible
material with a relatively high heat transfer coefficient, and
which is supplied with liquid hydraulic pumping fluid at a
temperature somewhat above the temperature of the blood. The
hydraulic fluid is cooled by heat exchange through a fixed volume
of energy exchange fluid that is in contact with the diaphragm of
the pump, and the cooled hydraulic fluid is returned to the power
supply. The amount of heat removed in the blood pump is that
required to maintain the system in equilibrium, and the amount of
mechanical energy supplied to the pump is that sufficient to reduce
the ventricular pressure of the host while maintaining a normal
supply of blood in dependence on the demands of the host. A basic
combination characteristic of our invention is an implantable power
supply serving as a source of hydraulic fluid under pressure at
elevated temperature, and as a sink of hydraulic fluid at lower
pressure, and connected thermally and mechanically to the
circulatory system by a blood coupler. The blood coupler comprises
a control unit for synchronizing the transfer of mechanical energy
to the blood from the power supply with the natural circulatory
system, in the process removing both thermal and mechanical energy
from the high-pressure fluid, to return low pressure, low
temperature fluid to the power supply.
The apparatus of our invention, and its mode of operation, will
best be understood in the light of the following detailed
description, together with the accompanying drawings, of a
preferred embodiment thereof.
In The Drawings,
FIG. 1 is a schematic piping diagram of an implantable heart-assist
system incorporating the multiple function blood coupler of our
invention;
FIG. 2 is a schematic elevational view, with parts shown in cross
section and parts broken away of a blood pump and blood pump
control unit forming a part of the apparatus of FIG. 1;
FIG. 3 is a schematic cross sectional elevational view, taken
substantially along the lines 3--3 in FIG. 2, showing a typical
cross section through the blood pump of FIG. 2; and
FIGS. 4 and 5 are schematic diagrams of a piston and cylinder
forming parts of the apparatus of FIG. 2, illustrating their
relative position at different points in a cycle of operation.
Referring to FIG. 1, we have shown a heart assist system comprising
generally a power supply designated 1, a blood pump control unit 3,
and a blood pump 5. In general, the power supply 1 serves to supply
hydraulic pumping fluid to the blood pump control unit 3 over a
line 7 at high-pressure and elevated temperature, and received
low-pressure fluid at a reduced temperature through a hydraulic
connecting line 9. The blood pump control unit 3 acts in response
to signals received from the blood pump 5, in a manner to appear,
to supply hydraulic pumping fluid, under a pressure below that in
the line 7, to the blood pump through a conduit 11, and to receive
the hydraulic fluid from the blood pump under a somewhat lower
pressure in response to the action of the natural ventricle.
The power supply 1 is described in more detail in U.S. Pat. No.
3,536,423, issued Oct. 27, 1970, on an application filed
concurrently with the present application by Thomas C. Robinson for
Dual Fluid Circulatory Support System and assigned to the assignee
of our invention. For the purposes of our invention, it may
comprise any suitable source of, and sink for, pumping fluid, in
which the source fluid is under pressure, and has an elevated
temperature by reason of carrying from the power supply the waste
heat generated in the process of raising the pressure of the return
fluid in the line 9 to the desired pressure for the line 7.
Since it is preferred to implant it in the body of the host, the
power supply is necessarily required to be highly efficient and to
be capable of producing the required hydraulic power output over a
long period of time. Specifically, a hydraulic power output of
between 5 and 20 watts for a period of at least a year, and
preferably several years, is desired. The primary energy source for
the power supply may be a rechargeable electrical device, but is
preferably a radioactive insotope such as plutonium 238 nitride.
Such a source is shown schematically at 13. Surrounding the
radioactive isotope 13 is shielding material 15 that may be of
6-millimeter thick tantalum having an initial impurity of 1 part
per million of plutonium 236. That amount of shielding is
sufficient to keep the gamma dose rate equal to or less than the
neutron dose rate for a period of 5 years.
Surrounding the shielded radioisotope 13 is a container of thermal
energy storage material 17 that preferably comprises a two-phase
constant temperature mixture of the eutectic composition of lithium
chloride and lithium fluoride that melts at 930.degree. F. In
operation, that material adjusts its relative concentration of
solid and liquid phases to maintain a constant temperature supply
of heat to a boiler schematically indicated at 19. The boiler 19
serves to raise a thermodynamic working fluid, preferably the same
fluid in the lines 7 and 9, and most preferably water, to a
suitable temperature and pressure for operating a steam engine. For
example, the temperature may be 900.degree. F, and the pressure may
be 800 p.s.i.a.
Working fluid under pressure from the boiler 19 is supplied to the
intake manifold of a conventional steam engine 21. The engine is
preferably of the single cylinder type shown and described in the
above copending application of Thomas C. Robinson in which a slug
of fluid is admitted at the beginning of the power stroke, and is
exhausted to a line 23 at the end of each power stroke. The engine
preferably drives a fly wheel 25, a sump pump 27, a hydraulic pump
29, and a feedwater pump 31, for purposes to be described.
Exhaust working fluid from the engine 21 is transmitted over a line
23 to a condenser 33 located in a high-pressure reservoir 35 to be
cooled and condensed by the liquid in the high-pressure reservoir.
Condensate at a low pressure of, for example, 2.9 p.s.i.a. is
transmitted from the condenser over a line 37 to the inlet of the
sump pump 27.
The outlet of the sump pump 27 is connected to a low-pressure
reservoir 39 over a line 41. The sump pump 27 is also connected
over a line 43 to the inlet of the hydraulic pump 29. The pressure
at the outlet of the sump pump 27 may be, for example, 15 p.s.i.a.
Since the pressure at the inlet of the sump pump 27 is the lowest
in the closed fluid cycle, net flow of leakage water, that
accomplishes the function of lubricating the moving parts in the
system, is to the inlet side of the sump pump.
The hydraulic pump 29 raises the pressure of the fluid in the
low-pressure reservoir to approximately 80 p.s.i.a. and supplies it
to the high-pressure reservoir 35 at that pressure over a line 45.
A relief valve 47 is connected across the hydraulic pump 29 to
ensure that the pressure in the high-pressure reservoir does not
exceed the desired value.
The feedwater pump 31 raises the pressure of the fluid in the
high-pressure reservoir from 80 p.s.i.a. to approximately 400
p.s.i.a. for admission to the boiler 19. Stalling of the engine 21
is prevented by a relief valve 49 connected across the feedwater
pump 31.
The low-pressure reservoir 39 is expansible, as schematically
indicated, to fluctuate in volume with the variations in demand for
pumping fluid as dictated by the demands upon the assist system by
the host. It will also be regulated in accordance with the demand
on the engine to maintain system stability, in a manner that will
next be described.
As will appear, the blood pump control unit 3 will demand more or
less high-pressure fluid through the line 7, in dependence on the
demands of the host for a larger blood supply, as when exercising,
or for a smaller blood supply, as when at rest. That variation in
demand will cause changes in the pressure in the high-pressure
reservoir 35.
The pressure in the reservoir 35 will determine the work done by
the hydraulic pump 29. Since the boiler temperature and pressure
are constant, because of the constant temperature of the thermal
energy storage material 17, the engine 21 will do a constant amount
of work per stroke. Thus, the engine will adjust its speed to the
demand by varying the speed of the flywheel 25, dividing the energy
produced per stroke between the flywheel and the hydraulic pump
29.
When the host demands more pumping fluid, and therefore reduces the
pressure in the high-pressure reservoir 35, the engine will speed
up to increase the speed of the pump 29, causing the pressure in
the reservoir 35 to be increased. When the pressure in the
reservoir 35 rises, the larger amount of energy demanded by the
pump 29 will cause the flywheel to slow down, thus lowering the
pressure in the reservoir 35. The engine 21 thus acts as a load
responsive coupling between the heat supply to the boiler 19 and
the mechanical energy supplied to the blood pump control unit 3
over the line 7.
As noted above, the engine 21 also drives the sump pump 27 and the
feedwater pump 31. However, because the flow through those pumps is
only that needed to maintain the necessary rate of flow of working
fluid to the engine 21, it is considerably smaller than the flow
through the hydraulic pump 29. For example, in practice, the flow
through the hydraulic pump 29 may be approximately 5,000 times the
flow through the pumps 27 and 31. Thus, the work required of the
hydraulic pump 29 is the primary factor governing the speed of the
engine 21.
In its relation to the blood pump control unit 3, the power supply
1 simply comprises a source of fluid under pressure in the line 7
at an elevated temperature, and a sink of fluid at a lower
pressure, with reduced temperature, in the line 9. As indicated in
FIG. 1, all of the parts of the power supply just described form a
sealed system located within a sealed, evacuated, insulated housing
and connected to the blood pump control unit over insulating
hydraulic lines so that no excessive heat transfer takes place
between those components and the body of the host.
As will be described, the blood pump control unit 3 transfers heat
and mechanical energy from the power supply to the blood pump 5.
The amount of heat transfered is that sufficient to maintain the
system in equilibrium, and the amount of mechanical energy is that
determined by the demands of the host as communicated to the
physiological control system. As will appear, both heat and
mechanical energy are exchanged through an intermediate fixed
volume of energy exchange fluid and thence across the fluid
boundary established by a thin flexible bladder 51 between the
blood and the pumping fluid in the blood pump 5.
Referring now to FIGS. 2 and 3, the blood pump control unit 3 and
the blood pump 5 will next be described.
The control unit 3 comprises a housing generally designated 53, of
metal such as stainless steel or the like, divided and connected
together in any convenient way, not shown, to facilitate assembly,
and including the moving parts and passages which together function
to control the supply of pumping energy to the blood pump. As
shown, the blood pump 5 is interconnected with the blood pump
control unit by a flexible tube 11 of any suitable conventional
synthetic resin or the like. The exterior surfaces of all parts,
including the power supply 1, the lines 7 and 9, the blood pump
control unit 3, the hydraulic line 11, and the blood pump 5, are
preferably coated with a surface which encourages tissue ingrowth,
as by flocking with a relatively matted coat of Dacron fibers or
the like in a manner known in the art per se. In addition to this
outer coating, an intermediate layer of thermal insulation, such as
a layer of silicone rubber, not shown, is preferably provided to
prevent heat transfer to the host except through the blood pump in
the manner to be described.
The blood pump 5 comprises an outer housing 55 of stainless steel
or the like, covered as just described and provided with an outlet
passage 57 adapted to be grafted to the aorta of the host by a
suitable conventional graft connection 59. An inlet passage 61 is
adapted to be secured to the left ventricle by means of a
conventional suture ring 63. The pump is provided with an inlet
check valve 65 and an outlet check valve 67 adapted to control the
flow of blood to and from the pump in a conventional manner known
in the art.
Within the housing 55 is the thin, flexible bladder 51, preferably
of polyurethane having a wall thickness on the order of magnitude
of 0.03 inch. That material is desirable because it is highly
durable, flexible, and chemically inert in the environment in which
it will be used, and it can be made relatively thin while retaining
a safe margin of strength. It is desirably thin, because, as noted
above, it is preferably used as a heat exchange surface to exchange
heat between the hydraulic fluid from the control unit 3 and the
blood stream. Preferably, the interior surface 69 of the bladder 51
is flocked with Dacron fibers and after implantation becomes coated
with an autologous pseudoendothelium surface of the type described
above. It has been found that the total heat transfer surface
available is adequate if the bladder is of appropriate size for the
volume of blood to be supplied at each stroke. Specifically, a
total bladder area of approximately 19.7 square inches is
satisfactory.
The flexible hydraulic connecting tube 11 is connected between a
suitable outlet fitting 71 formed in the housing 55 and a
corresponding fitting 73 on the blood pump control unit 3.
The fitting 73 is formed at the outlet of a cylinder 75 in which
there is an expansible chamber formed by a piston 77 sealed to the
end of the cylinder 75 by means of an expansible metal bellows 81.
In the space 83 inside of the bellows 81 and piston 77 is a fixed
trapped volume of fluid communicating through the tube 11 with the
chamber around the diaphragm 51 in the blood pump 5. The fluid in
the space 83 and in the outer portion of the blood pump 5 is
preferably an isotonic aqueous saline solution, to minimize the
consequence of any leakage that might occur into the blood. The
space around the bellows 81 and piston 77 is in communication with
the exhaust fluid line 9, by way of a passage 85 formed in the
housing 53 of the blood pump control unit. That arrangement permits
expansion and compression of the expansible chamber formed by the
bellows and piston, and facilitates heat transfer between the
isotonic pumping fluid and the fluid from the power supply.
Formed integral with the piston 77 is a smaller piston 79 slideable
in a cylinder 87 formed in the housing 53. The ratio of the areas
of the pistons 79 and 77 is such that high-pressure fluid, at
approximately 80 p.s.i.a. supplied to the pump control unit in a
manner described above, will be converted to approximately 15
p.s.i.a. in the space 83 to simulate the systolic pressure that
would be produced in the natural circulatory system by a normally
functioning heart.
High-pressure hydraulic fluid is supplied to the blood pump control
unit 3 through the flexible line 7, and low-pressure exhaust fluid
at approximately 15 p.s.i.a. is returned to the fluid pressure
source through the flexible line 9. The high-pressure line 7 is
connected to the unit 3 by means of a suitable fitting shown at 89,
and the low-pressure line is connected to a suitable fitting 91
formed in the housing 53. The valve 93 is urged to the position
shown by a spring 99, and is at times switched down to the lower
position described above by hydraulic means to be described.
In the position of the parts shown, the upper end of the spool
valve 93 is in communication with the low-pressure return line 9
over a passage 101, a passage 103, a reduced portion 105 formed on
the piston 79, a passage 107, and a restricted orifice 111 in
parallel with a spring-biased check valve 113. At the same time,
the upper part of the piston 79 is connected to the high-pressure
inlet passage 7 over a conduit 115, a reduced portion 117 formed on
the spool valve 93, and a passage 119.
In a second position of the piston 79, lower than in FIG. 3 and
illustrated schematically in FIG. 4, ports 103 and 107 are closed
by the piston 79, and the fluid above the spool valve 93 is trapped
so that the spool valve cannot move. In a third position of the
spool valve 79, still lower than in FIG. 4 and illustrated
schematically in FIG. 5, the upper portion of the spool valve 93
communicates with the high-pressure line 7 through the passage 101,
a passage 121, the reduced portion 105 formed on the piston 79, a
passage 125, and the passage 119. In that position, the conduits
103 and 107 remain closed by the upper portion of the piston
79.
The lower portion of the spool valve 93 communicates directly with
the return line 9 through a passage 127. In the second position of
the spool valve 93, in which it is at the bottom of the cylinder 95
and engaging the ledge 97, the passage 115 is closed by the top
portion of the spool valve 93 and the top of the cylinder 79 is in
communication with the return line 9 over a passage 129, a second
reduced portion 131 formed on the spool 93, a passage 133, and the
reduced orifice 111 in parallel with the check valve 113.
Preferably, the pumping fluid in the cylinder 75 surrounding the
piston 77 and the bellows 81, the high-pressure fluid in the line
7, and the low pressure fluid in the line 9, are all a part of the
same closed system of hydraulic fluid that is preferably water.
Moving parts such as the spool valve 93 and the piston 79 are
preferably provided with graphite bearings, not shown, and some
leakage is permitted so that the water serves as the lubricant for
the moving parts.
The operation of the apparatus of our invention will next be
described on the assumption that the power source of FIG. 1 is in
operation to provide high-pressure working fluid at 80 p.s.i.a. and
an elevated temperature of, for example, 140.degree.! F., to the
line 7, and to receive low-pressure fluid at approximately 15
p.s.i.a. and a reduced temperature of approximately 115.degree. F.
and selected to produce a net average temperature rise in the blood
stream of approximately one-quarter to one-half of a degree. Upon
those assumptions, and on the further assumption that the parts
have just reached the position shown in FIG. 2, operation of the
apparatus of FIGS. 2 and 3 will be described, with reference to
FIGS. 2 and 3 and to the schematic diagrams of FIGS. 4 and 5.
In the position shown in FIG. 2, the bladder 51 will have been
filled with blood in an amount equal to that supplied by the last
systolic contraction of the ventricle plus a residual amount
allowed to prevent contact of the opposite walls of the bladder 51,
as seen in FIG. 3. The reason for preventing the walls of the
bladder from coming into contact is to prevent damage to blood
cells that may be occasioned thereby.
With the parts in the position shown in FIG. 2, the piston 79 will
be in communication with the high-pressure fluid in the line 7 as
described above, and the piston 77 will be driven down to express
fluid in the expansible chamber 83 into the outer chamber of the
blood pump 5. That will cause contraction of the bladder 51 as
shown in FIG. 3, the closing of the inlet valve 65, and the opening
of the outlet valve 67 to express blood to the aorta. The spool
valve 93 will be initially held in the position shown in FIG. 2 by
the spring 99. The top of the spool valve 93 is exposed to return
pressure in the line 9 over the conduits 101, 103, 107 and the
reduced orifice 111. The bottom of the spool valve is also at
exhaust pressure, to which it is exposed over the line 127.
As the piston 79 descends to the position illustrated in FIG. 4,
the passage 103 will be cut off, and the fluid above the spool
valve 93 will be trapped, locking the spool valve in the position
shown for the time being. As the piston 79 nears the bottom of its
stroke, the reduced portion 105 will expose the passage 121 to the
passage 125, admitting high-pressure fluid from the line 9 to drive
the spool valve 93 down into its bottom position. That position is
illustrated in FIG. 5. In that position, the passage 115 will be
closed by the top part of the spool valve 93, and the passage 129
will be connected to the passage 133 over the reduced portion 131
of the spool valve 93. Nothing further will occur until the next
systolic contraction of the natural ventricle.
When the spool valve 93 is against the ledge 97 in FIG. 2, the
apparatus will await the next systolic contraction of the natural
heart. When that occurs, blood under pressure will be supplied from
the ventricle to the inlet conduit 61, opening the check valve 65
and closing the check valve 67 in the blood pump. The bladder 51
will expand as it fills with blood, expressing fluid between the
housing 55 and the bladder 51 upward through the conduit 11 to the
expansible chamber 83. That will cause the piston 77 to be
raised.
As the piston 77 is raised, carrying with it the piston 79, the
first significant event will be the closing of the passage 121 to
trap high-pressure fluid over the spool valve 93 and hold it down
against the ledge 97. The next significant event will be the
opening of the conduit 103 to the conduit 107 by the reduced
portion 105 on the piston 79 as it continues to travel upward under
natural ventricular pressure, transmitted from the blood pump 5 and
multiplied by the ratio of the areas of the pistons 77 and 79. When
that occurs, the top of the spool valve 93 and the top of the
piston 79 will both be in communication with the restricted orifice
111, whereas the bottom of the spool valve 93 is directly in
connection with the return line 9.
There will be a pressure drop across the orifice 111 that depends
upon the flow of fluid through the orifice occasioned by the upward
movement of the piston 79. That pressure drop will remain until,
towards the end of the natural systole, the ventricular blood
pressure drops and movement of the piston 79 ceases. Until that
time, the back pressure exerted by the piston 77 and the blood pump
5 will be limited by the check valve 113, which is set to unload at
a predetermined pressure that will not overtax the natural
ventricle.
When the end of the natural systole occurs, with the corresponding
pressure drop described above, the spring 99 will snap the valve 93
back to the position shown in FIG. 2 and a new pumping cycle will
begin. Since that can occur at any time after the ports 103 and 107
are opened by the reduced portion 105 of the piston 79, the volume
of fluid taken into the expansible chamber 83 will be determined by
the amount of the volume of blood expelled during the natural
systole, and may vary from stroke to stroke in dependence on the
demands of the host. This same volume is always expelled at the
next stroke, because the volume discharged from the chamber 83 is
limited by the opening of the ports 121 and 125 as the piston 77
approaches the bottom of its stroke.
As noted above, the fluid in the line 79 carries excess heat
extracted from the working fluid in the condenser 33 in FIG. 1.
That heat is discharged to the blood stream in a manner next to be
described.
The pumping fluid in the blood pump 5, the line 11 and the
expansible chamber 83 exchanges heat with the fluid in the
hydraulic lines 7 and 9 through the conductive metal walls of the
piston 77 and the bellows 81. The fluid in the expansible chamber
83 is transferred back and forth between the blood pump control
unit 3 and the blood pump, and exchanges heat with the blood
through the diaphragm 51. The excess heat in the power supply
system is thereby discharged without causing any physiologically
significant increase in blood temperature. The heat that is added
to the blood is dissipated by the normal physiological processes of
perspiration, conduction, convection and respiration.
It will be apparent that in the apparatus just described, the
bladder 51 in the blood pump serves both to exchange heat between
the power supply and the blood stream and to sense the natural
ventricular rhythm and transmit a pressure control signal to the
blood control unit 3 toward the end of the natural systole. The
volume of fluid taken into the chamber 83 at each stroke is
determined by the volume of blood delivered to the pump by the left
ventricle during its last systolic contraction. That volume is
determined in dependence on the current needs of the host as
communicated to the natural heart by the physiological motor
control system of the host. Thus, the circulatory support system is
fully synchronized with the natural circulatory system both in
timing and in flow rate.
While we have described our invention with respect to the details
of a preferred embodiment thereof, many changes and variations will
become apparent to those skilled in the art upon reading our
description, and such can obviously be made without departing from
the scope of our invention.
* * * * *