U.S. patent number RE41,394 [Application Number 11/333,750] was granted by the patent office on 2010-06-22 for implantable device for utilization of the hydraulic energy of the heart.
Invention is credited to Mogens Bugge, Goran Palmers.
United States Patent |
RE41,394 |
Bugge , et al. |
June 22, 2010 |
Implantable device for utilization of the hydraulic energy of the
heart
Abstract
A device, potentially implantable in a living organism, intended
to utilize at least a part of the hydraulic energy generated by the
heart (10)--the primary unit--at the natural phases of work when
the cavities of the heart (11, 12 and 16, 17) are filed with blood.
The device includes at least one secondary unit (24), which is
connectable to the cardiovascular system of the organism and
arranged to utilize said hydraulic energy. The secondary unit is
represented by at least one hydraulic motor (24a) arranged to
transfer the hydraulic energy to a transferal organ (28). The
transferal organ (28) is arranged to influence at least one
tertiary unit, for example an executive device (29), which is
constructed in order to convert the transferred energy to an
alternative form of energy, with the purpose to influence certain
defined functions within the organism. Preferably is arranged a
regulating device (30) in order to control running parameters of
the unit.
Inventors: |
Bugge; Mogens (113 20 Goteborg,
SE), Palmers; Goran (436 Askim, SE) |
Family
ID: |
20416204 |
Appl.
No.: |
11/333,750 |
Filed: |
January 17, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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PCT/SE00/01355 |
Jun 26, 2000 |
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Reissue of: |
10026224 |
Dec 19, 2001 |
06827682 |
Dec 7, 2004 |
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Foreign Application Priority Data
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Jun 23, 1999 [SE] |
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9902381 |
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Current U.S.
Class: |
600/16;
623/3.1 |
Current CPC
Class: |
A61M
27/002 (20130101); A61M 60/871 (20210101); A61M
60/882 (20210101); A61M 60/113 (20210101); A61N
1/3785 (20130101); A61M 60/857 (20210101); A61M
60/274 (20210101); A61M 60/50 (20210101); A61M
60/258 (20210101); A61M 60/562 (20210101); A61M
60/40 (20210101); A61M 1/16 (20130101) |
Current International
Class: |
A61M
1/10 (20060101) |
Field of
Search: |
;600/16,17
;601/84,150,152,153 ;604/65,66,67
;623/3.1,3.11,3.12,3.16,3.17,3.18,3.19,3.22,3.23,3.24,3.25,3.27,3.28,3.3 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
International Search Report mailed Oct. 11, 2000 for Application
No. PCT/SE00/01355. cited by examiner.
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Primary Examiner: Layno; Carl H
Assistant Examiner: Oropeza; Frances P
Attorney, Agent or Firm: Ostrolenk Faber LLP
Parent Case Text
CROSS REFERENCE TO RELATED APPLICATIONS
This application is a continuation of PCT International Application
No. PCT/SE00/01355 filed Jun. 26, 2000 which PCT Application claims
priority to Swedish Application No. 990238 1-4 filed June 23, 1999.
Claims
What is claimed is:
1. A device for implantation, able to make use of at least part of
the hydraulic energy generated by a heart at its natural phases of
work, said device including at least one actuator connected to the
cardiovascular system of an organism, said actuator arranged in
order to transfer the hydraulic energy to an executive organs, said
executive organ arranged to influence certain defined functions
within or outside the organisms, characterised by the actuator
consisting of a hydraulic motor located outside the cardiovascular
system of the organism, said hydraulic motor arranged to conduct at
least part of the hydraulic fluid to and fro between the hydraulic
motor and its connecting site to the organism, and/or between
arteries and/or veins and that the executive organ consists of at
least one pump powered by the hydraulic motor, said pump delivering
hydraulic fluid to and fro vessels synchronously or asynchronously
in relation to the rhythm of the heart with or without pressure
amplification.
2. A device according to claim 1, wherein a regulating mechanism is
arranged between the hydraulic motor and the pump for adjusting
running parameters of the device.
3. A device according to claim 1, wherein the hydraulic motor is
connected to more than one pulsating pressure source.
4. A device according to claim 1, wherein the hydraulic motor is a
deplacement motor, and that one of a piston rod and a pusher plate
is connected to one of a piston and a membrane of the deplacement
motor and that the executive organ is one of a piston pump, and a
pressure amplifier.
5. A device according to claim 1, wherein the hydraulic motor (24)
is a rotation motor for example a turbine and that the executive
organ (29) is a rotation pump (54) or a similar device, and that a
magnetic connection (102) or a similar device is arranged between
the hydraulic motor (24) and the executive organ (29). (FIGS. 16,
17).
6. A device according to claim 1, wherein the hydraulic motor, the
executive organic and a transferal organ arranged in between the
hydraulic motor and the executive organ are integrated in one
unit.
7. A device according to claim 6, wherein the hydraulic motor (24a)
is a first bellows (37) influenced by a spring and the transferal
organ (28) is a pusher plate (59) connected to said first bellows,
said pusher plate includes an opening (67) supplied with a stop
valve (39) and that the executive organ (29) is a second bellows
(38) connected to said pusher plate (59) of said first bellows (37)
and that said second bellows is configured with a cross sectional
area being different to the cross sectional area of said first
bellows (FIGS. 6, 20).
8. A device according to claim 1, wherein the hydraulic motor (24a)
consists of two piston-- or bellows motors (24a), working in
parallel, each motor connectable to a ventricle of the heart (12,
17) and where said motors are interconnected by a regulating
mechanism (30), (FIG. 5).
9. A device according to claim 4, wherein the pressure side of said
hydraulic motor (24a) and the piston pump (24b) are arranged to
communicate with each other through a connection tube (41)
containing a stop valve (3) and that the piston--and pump rods (28,
34) are interconnected via a regulating mechanism (30), (FIG.
7).
10. A device according to claim 4, wherein the piston pump has a
piston rod, the piston rods of the hydraulic motor and of the
piston pump being interconnected via a regulating mechanism as a
counterpulsator.
11. A device according to claim 1, wherein a shuttle valve (46) is
included at the anterior aspect of the hydraulic motor (24a) and
that said shuttle valve is arranged to be able to establish
connection between the heart and the hydraulic motor in the
contraction phase of the heart while being able to establish
connection between the hydraulic motor and a vein (51) in the
relaxation phase of the heart (FIG. 10).
12. A device according to claim 1, wherein the hydraulic motor
(24a) is arranged to power a pump (54), said pump having a n inflow
opening which is connected to a compartment of the body (56) and
having an outflow opening (57) being connectable to the circulatory
system of the body (FIG. 17).
13. A device according to claim 1, wherein the hydraulic motor (24)
is connected to a pump working as a pressure amplifier (60), said
pump arranged to raise the blood pressure to dialysis pressure, and
that said amplifier is connected to the blood side (62) of an
implanted apparatus for dialysis (61) while the water side (63) of
the dialysis apparatus is connected with a tube (71) for transport
of liquid of the body (FIG. 19).
14. A device according to claim 1, wherein the hydraulic motor (24)
is arranged to power a predilution pump (70) parallel with the
executive organ (29), (FIG. 20).
15. A device according to claim 7, wherein the bellows (37) active
as hydraulic motor (24a) contains at least one other bellows (38)
and the said bellows is arranged as a pump (38), and that the first
and second bellows share a common pusher plate (59) adjusted by a
regulating mechanism (30) in one end and that each bellows has its
fluid connection at the other end (FIGS. 23,25).
16. A device according to claim 15, wherein a third bellows (78) is
arranged concentrically within existing first and second bellows
(37,38) and that two of the bellows are connected to each a
ventricle of the heart while the third bellows is connected to an
artery (50), (FIG. 26).
17. A device according to claim 1, wherein at least one membrane
(79) is arranged between the heart (10) and the hydraulic pump (24)
and/or between the hydraulic pump and the executive organ (29),
said membrane being for example a bladder (80, 81, 82) or a similar
device, said membrane arranged to separate the blood side form the
hydraulic fluid of the corresponding unit (FIG. 25,.sctn.).
18. A device according to claim 10, wherein the hydraulic motor
(24a) is connected to one ventricle (17/12) of the heart (10) and
that the pump (24b) acting as counterpulsator is connected to an
artery deriving from the other ventricle (17/12) resulting in an
action where one ventricle powers the hydraulic motor (24a) in
systolic phase, while in diastolic phase a pressure is generated in
the artery (15/20) of the opposite side. (FIG. 18).
19. A device according to claim 1, wherein sensors (77), gauges
(83) and/or registering devices (75) are located within the
organism in order to detect or quantify specific functions of the
body, with the purpose to influence the regulation of the hydraulic
motor (24) and/or the executive organ (29). (FIGS. 15,21,27).
20. A device according to claim 19, wherein signals from said
sensors, gauges or registering devices are arranged to be processed
by a preferably implanted computer (91). (FIG. 27).
21. A device according to claim 1, wherein a regulating mechanism
(30) is arranged and includes different control units (31,32,33),
said control units being arranged to be adjusted or regulated by a
preferably implanted computer (91) and that said computer is
arranged to communicate with the surrounding via a data port
located under the skin.
22. A device according to claim 21, wherein the regulating
mechanism (30) includes a first control unit (31) for limitation of
stroke of for example the piston rod (28) of the hydraulic motor
(24a), and/or includes a second control unit (32) for regulation of
the gear between the hydraulic motor (24a) and the hydraulic pump
(24b) and/or includes a third control unit (35) for regulation of
the settings of the spring.
23. A device according to claim 1, wherein the device includes a
shuttle valve (46) in the system after the hydraulic motor (24a) in
the direction of the flow, said shuttle valve arranged to close one
first opening of the valve (48) against a vein each time pressure
is raised, while at the same time open the port connected to the
hydraulic motor or a similar device. (FIG. 11).
24. A device according to claim 4, wherein the displacement motor
is one of a piston motor, a compression chamber and a bellows.
Description
The present invention refers to a device, implantable in a living
organisms, for the utilisation of at least part of the hydraulic
energy developed by the heart (the primary unit), which is acquired
by the natural work of the heart i.e. by the contraction of the
heart (the systolic phase) where the blood is put under pressure,
followed by the relaxation phase (the diastole), where the
ventricles of the heart are filled with blood. The device comprises
at least one secondary unit connected to the cardiovascular
system.
THE BACKGROUND AND PROBLEMS OF THE INVENTION
The heart is well known to work as two deplacement pumps which are
functionally separated apart, and which work sycncronously, in the
way that the right pump transports blood to the pulmonary
circulation, whereafter the oxygenated blood returns to the left
pump. Thereafter, the left side ejects the oxygenated blood to the
peripheral circulation of the body i.e. to the vascular system of
the entire organism. Finally, the blood returns to the inlet of the
right pump.
The force of the pump is generated by the contraction of the cells
of the myocardium, which surrounds the atria and the ventricles of
the heart. The direction of the circulation is controlled by
unidirectionally acting valves. The energy delivered by the heart
to the surrounding, mainly to the blood consists primarily of
pressure-volume work against the blood, kinetic work and heat.
It is previously known to assist the circulation, when the heart is
fainting, by external force. Such assist is typically powered by
pressurized air or electricity as energy source located outside the
body. It has even been suggested to utilize energy converted from
muscle, other than the heart, for example muscle of the legs, or
from the back, as energy for the circulating blood via some sort of
converting mechanism.
To add energy, from outside the body, to implanted assist devices
has previously been used and is principally not difficult. But it
may cause discomfort and be complicated for the patient due to
tubings and cables penetrating the skin. Such connections limit the
patient's degree of freedom to special rooms or to trolleys
equipped with batteries and computers. If therefore, one could use
energy existing within the body, the patient would experience a new
degree of freedom. The circulation of living creatures, including
man, is normally kept in balance between the cardiac output and the
resistance of the peripheral arteries, in the way that blood
pressure is kept within narrow limits. This is necessary since
several organs cannot work and/or survive if the blood pressure
drops below, or increases above extreme levels. The kidneys and the
brain are organs known to be sensitive to variations in blood
pressure. Thus, if the heart in a human being faints, and cannot
pump out the blood with enough force to keep the arterial mean
blood pressure slightly above 50 mm Hg, the person will loose
consciousness. If the kidneys are exposed for a similarly low
arterial pressure, at least if exposed for a considerable long
time, the urine production will cease. When the heart is fainting,
and for some reason or another cannot generate a sufficiently high
blood pressure, the person will die. This is through for left side
fainting, but also for right side fainting if the right pump cannot
overcome the resistance of the lungs.
The fact that the heart sometimes cannot pump out the blood to the
circulation with a sufficiently high pressure does not necessarily
mean that the heart cannot deliver enough energy to the
circulation, if mechanical, and other conditions, where correct. In
contrary, several examples can be given, where the heart is
extremely powerful and has hypertrophied to a size 2-3 times the
normal, over years, but still the pressure is low. One typical
example for such a situation, is a heart with one or more valves
leaking, or a dilated heart, which cannot deliver a sufficiently
high pressure to the circulation. The energy consumption of such a
heart is much higher than the normal delivery to the circulation at
rest (1 watt). The efficiency, i.e. the PV-energy+the kinetic
energy/ the total energy for a normal heart is around 15%, while
for a diseased heart, especially if dilated the efficiency is
considerably lower than that.
A normal heart has a relatively low efficiency as a pump, compared
to industrial pumps. Energy losses do arise (among other things)
since the ventricles, at each contraction, as first step, have to
generate a contraction of the ventricular wall, which allows the
ventricular pressure to reach the aortic pressure (or the pressure
of the pulmonary artery for the right pump); the ventricle wall is
pre-tightened. This contraction leads to energy losses, which are
proportional to the diameter of the ventricles in square, and
therefore, these losses are great when the ventricles are dilated.
In the second phase of the contraction, the ventricles have to
increase the tension of the ventricular wall further, resulting in
a ventricular pressure higher than the aortic pressure whereby the
ejection of the blood takes place. During the ejection, the volume
of the ventricles decreases, and therefore, the wall thickness of
the ventricles increases. This remodeling of the muscle mass also
leads to energy losses which in some diseases (for example at
extremely hypertrophic hearts) may be considerable.
The way more than normal energy can be extracted from a fainting
heart, is realized by comparing the pressure volume relation
demonstrated in FIG. 1, which is en example given for a healthy
heart (with an ejection fraction of 80%), with the relation given
in FIG. 2, for a diseased heart (with an ejection fraction of 40%).
Both figures are presented as PV-diagrams. The pressure-volume
curve appears as a modified square anti-clockwise and the area
within the loop represents the work of the heart (EW=External Work)
on the blood. The area PE represents energy within the heart
converted to heat at each contraction of the heart, which therefore
is to be considered as wasted energy.
It is noted that the area of the surface PE (in FIGS. 1, 2 and 3)
is not directly correlated to the one of the EW surface. The
PE-area is proportional against the wasted energy but must be
multiplied by a factor over 10 in a weak heart.
FIG. 2 is an example of how a diseased heart works. In order to
achieve same minute volume and frequency as a healthy heart, blood
is retained within the ventricle after each contraction and even
the mean pressure is below normal level. The efficiency of the
heart is decreased.
The fact that retained blood within the ventricle after each
contraction does lead to energy loss should not be considered as if
the retained blood should possess potential energy released in
diastole. This is not the case since the blood is not compressible.
In contrast, energy is lost since the ventricle must be
pre-tightened before it can create a pressure high enough to start
the ejection of the blood. This pre-tightening is well known energy
consuming and is proportional to the volume of the ventricle.
Besides this factor, there are several other important factors that
decide the oxygen consumption of the heart and thereby the energy
consumption, the magnitude of the lost energy and the efficiency of
the heart. These are described in the book "The Heart Arteries and
Veins" 8 Edition. McGraw-Hill Inc., being for example the mass of
the heart, the level of the pre-tightening, the frequency of the
heart and the hormones influencing the heart. In contrast, as a
paradox, the external work of the heart is not the main factor to
decide the oxygen consumption since maximally 15% of the energy of
the heart is converted to external work (for a healthy heart). When
a heart wakens, often first step is a dilatation of the ventricle,
later through an increase of its mass whereby the losses increase
dramatically.
The idea to take out more blood at the contraction of the
ventricles (systolic phase) is old and used every day.
Pharmacologically it is easy to dilate the capacitance vessels of
the arterial system (i.e. an afterload reduction) and thereby
increase the stroke volume and the minute volume. But the price is
low blood pressure and the limits within one operates are narrow.
Likewise, one can influence the heart mechanically to eject more
blood in each cycle. This may for example be achieved by diastolic
counterpulsating, and one example of such pumps is the aortic
balloon pump.
A diastolic counterpulsator works in its simplest form in the way
that when the heart in systolic phase ejects its contained blood,
the counterpulsator accumulates part of this volume outside the
cardiovascular system for example in a pump cylinder connected to
the artery in a groin. Thereby, the systolic resistance is reduced
and the systolic blood pressure is kept low which ameliorates the
ejection of the blood from the heart.
In diastolic phase, when the valve between the heart and the
arterial system is closed, an external force, i.e. a motor, is used
to press back the blood from the counterpulsator to the arterial
system. The diastolic pressure is increased, as is the mean
pressure. It is noted that this way of pumping results in a
mirrored arterial blood pressure curve. This is true for external
counterpulsators as described above, but also for internally
located counterpulsators like the aortic balloon pump, which is the
most commonly used assist pump in modern cardiac surgery. The
mechanism is simple and intelligent--bit it needs externally added
energy.
The counterpulsator is a device well described in the medical
literature i.e. "Cardiopulmonary Bypass" by Kenneth M. Taylor,
1986. Chapman and Hall Ltd., 9 chapter.
By U.S. Pat. No. 4,938,766--R. Jarvik--is known an implantable
prosthesis--a device--for amelioration of the perfusion of the
natural cardiovascular system without adding energy from outside
the body. However, the device cannot store the energy for more than
part of a cardiac cycle. Nor can it render the arterial pressure
curve in mirrored version, which is the case for the
counterpulsator. It flattens out the blood pressure curve. It may
increase the mean pressure in the arterial system, and it may
enhance the take out of more energy from the heart (more than
before connecting the device), but it will decrease the maximum
systolic pressure. Thus, the device cannot solve the pressure
demand from peripheral organs like the brain and the kidneys, which
have an absolute pressure demand in order to survive.
The Purpose Of The Invention And The Solution Of The Problem
The purpose of the present invention is to achieve a device which,
as mentioned in the introduction, without adding external--from
outside the body--energy, can utilize energy created within the
body, for different purposes and in different ways, depending on
which disease is actual. Some examples of possibilities to be
opened are given: to correct a diseased heart, by correcting the
pump modus of the heart in the way that the PE is decreased; to
make possible, in patients with edema, like for example in patients
with ascites, a system to eliminate the edema without control
mechanisms; to control and manipulate natural and artificial
openings of the body; to supply implanted apparatus like
pacemakers, electric pulsgenerators like ICD apparatus with power;
to supply computers or similar equipment with energy in order to
control implanted electronic equipment which may be in contact with
the central nervous system etc.
The purpose is among other to bring back the modus operandi of the
heart to a normal pump modus and thereby reduce the lost energy,
while the energy delivered to the surrounding (at rest) is
constant. These purposes have been solved by the characteristics
mentioned in the patent claims.
DESCRIPTION OF THE DRAWINGS
The invention will be described in detail below together with some
examples with referral to enclosed drawings.
FIG. 1 demonstrates a pressure--volume--diagram (PV--diagram) of a
healthy heart;
FIG. 2 demonstrates a similar PV--diagram for a fainting heart;
FIG. 3 demonstrates a diagram similar to FIG. 2, for a fainting
heart, corrected with the device according to the present
invention.
FIG. 4 demonstrates a heart seen from its anterior aspect and
partly in a 3 dimensional way and applied with a very schematic
device according to a first variant of the present invention.
FIG. 5 demonstrates schematically a second variant of a device
according to the present invention with two hydraulic cylinders
working parallel to each other.
FIG. 6 demonstrates a third variant of the invention by a device
for pressure amplification using a double bellow device.
FIG. 7 demonstrates schematically a modified pressure amplifier
with blood flow through the hydraulic motor as well as through the
hydraulic pump. The device works synchronously with the beats of
the heart.
FIG. 8 demonstrates another example of a pressure amplifier where
the pump works in counter phase compared to the heart beats, i.e. a
counterpulsator.
FIG. 9 demonstrates schematically a device according to the present
invention for the conversion of force applied by linear motion to
electricity.
FIG. 10 demonstrates a device for absorption of energy by
conduction of blood from the arterial to the venous system.
FIG. 11 demonstrates a variant of the counterpulsator demonstrated
in FIG. 8.
FIG. 12 demonstrates a pressure--time--diagram for a normal heart
without any assist device.
FIG. 13 demonstrates a similar pressure--time--diagram for a heart
connected to a pressure amplifier according to the present
invention.
FIG. 14 demonstrates a similar pressure--time--diagram for a heart
connected to a counterpulsator according to the present
invention.
FIG. 15 demonstrates very schematically a regulating mechanism for
devices according to the present invention.
FIG. 16 demonstrates schematically a device for generation of
electricity by using a hydraulic motor.
FIG. 17 demonstrates schematically a device consisting of a
hydraulic motor and a hydraulic pump in a composite unit,
constructed for drainage purpose of compartments of the body.
FIG. 18 demonstrates a device arranged to transfer energy from one
ventricle to the contralateral circulation.
FIG. 19 demonstrates schematically an implantable device for
dialysis according to the present invention.
FIG. 20 demonstrates schematically an implantable device for
dialysis supplied with pressure amplifier and predilution
mechanism. Water for dialysis is automatically added before the
filter unit.
FIG. 21 demonstrates schematically a device according to FIG. 8,
which in addition is connected to a combined motor and
generator.
FIG. 22 demonstrates a device according to the present invention
arranged as a pressure amplifier placed in a specific organ like
for example a leg.
FIG. 23 demonstrates a variant of the device according to FIG. 8
arranged as a counterpulsator.
FIG. 24 demonstrates a variant of the device according to FIG. 4
arranged with a closed circuit pressure medium system.
FIG. 25 demonstrates a variant of the device according to FIG. 8
arranged with a double closed circuit medium system
FIG. 26 demonstrates a modification of the device according to FIG.
25 arranged with a triple closed circuit medium system.
FIG. 27 demonstrates a ventricle containing a gauging device.
GENERAL DESCRIPTION OF THE INVENTION
The main purpose of the invention is to utilize and/or to convert
at least part of the energy delivered by the heart--also called the
primary unit--to the blood for specific or other purposes,
primarily within the body, but in some specific cases even outside
the body. The device needed to extract energy from the pump work of
the heart via the blood depends on the purpose the energy is
intended to be used for and consists in most cases a conventional
hydraulic motor--even called the secondary unit--which has been
adjusted according to its specific purpose. The hydraulic motor,
which is powered by the pressurized blood, converts the hydraulic
energy back to mechanical or electric energy. After this
conversion, the energy can be used immediately, stored for a short
period (a cycle of the heart) or stored for a longer time. The
energy can be used to run different apparatus i.e. one or more
pumps, an electric motor, a control mechanism or a regulator etc.
The actual equipment will decrease the pressure within the heart,
Ph and the residual volume Vr after the contraction of the
ventricle/ventricles.
If the hydraulic energy is converted within the body to
electricity, new possibilities will appear for self supply with
limited amounts of electric power, to be used for several purposes,
for example to run pumps to maintain the circulation, to generate
blood pressure higher than the normal pressure, generated by the
normal or by the diseased heart etc.
The energy delivered by the heart to a hydraulic motor is V*dp
where V is volume and dp is reduction in pressure of the blood when
passing the hydraulic motor. The energy spent by the heart to
deliver V*dp is much higher than V*dp itself.
One way to absorb energy from the pressurized blood is by help of a
hydraulic motor connected to the heart directly, normally to one or
both ventricles, and most frequently to the left ventricle. But
principally, any of the atria and ventricles of the heart may be
connected to each its motor and work independently or more or less
interconnected.
By adjusting the characteristics of the hydraulic motor, more blood
may be ejected the natural way and to the motor than before
connection to the device. The pressure in the heart may be same as
normal--or lower, depending on the characteristics of the motor. At
diastole, the ventricle needs to be filled with blood, and the most
natural way to do this is to empty the motor directly through the
inflow connection, which in that case will be the outflow
connection as well. Thus, the blood from the motor is mixed with
the blood filling the ventricle the natural way. But emptying an
filling of the motor does necessarily have to take place by the
same route. If the motor empties its blood "upstream" in the
circulation, the blood will automatically find its way down to the
same ventricle (although it may be a burden for the circulatory
system to a certain degree on its way back).
As mentioned, the energy absorbed from the heart by the motor may
be used for several purposes. One example is to lead back the
energy directly to the circulation--or later, at the same time as
electricity is generated and stored in an accumulator. Arranged in
this way, the net amount of energy transferred to the circulation
will be the same, less or more than before connection to the motor.
The profile of the blood pressure can be manipulated and the mean
blood pressure can be increased.
It is even possible with this device to take out a maximum of blood
volume for the ventricle at a pressure so low that the valve
between the ventricle and the circulation never opens, which
normally is inconsistent with life, and still absorb energy at this
low pressure. The device may give back the energy to the
circulation and thereby generate a sufficiently high pressure to
guarantee life --without adding energy from the surrounding.
DESCRIPTION OF SOME EXAMPLES
To get e better understanding of the invention, FIG. 4 demonstrates
a human heart 10 partly in a 3 dimensional presentation, where 11
indicates the left atrium, 12 the left ventricle, 13 the mitral
valve, 14 the aortic valve, 15 the main body artery (the aorta), 16
the right atrium, 17 the right ventricle, 18 the tricuspid valve,
19 the pulmonary valve, 20 the pulmonary artery, 21 two caval veins
and 22 four pulmonary veins.
The blood is pumped from the circulatory system of the body (the
periphery) via the two caval veins 21 to the right atrium 16,
passes through the tricuspid valve 18 to the right ventricle 17 and
is pumped through the pulmonary valve 19 to the pulmonary artery.
In the lungs the blood absorbs oxygen and continues its flow to the
pulmonary veins 22 to the left atrium 11 and further via the mitral
valve 13 to the left ventricle 12, which pumps out the blood
through the aortic valve 14 to the main body artery 15.
To the lower part of the left ventricle 12 is connected, i.e. by an
operation, a connection tube 23, which connects the heart 10--the
primary unit--with an implanted secondary unit 24. This is
illustrated in a considerably greater scale than the heart and is
in this example a hydraulic motor 24a. Its plus side is a variable
volume chamber i.e. a cylinder 25 and within the cylinder is an
axially movable piston 26, which on its minus side is influenced by
a return spring 27. This spring tends to move the piston to its one
end at the opening of the connection tube 23, when the hydraulic
pressure of the heart comes to an end. In stead of a cylinder the
hydraulic motor may consist of a bellows cylinder or a similar
device. To the piston 26 is connected a transferal organ 28, which
in FIG. 4 consists of a piston rod the purpose of which is to
transfer at least part of the hydraulic energy generated by the
heart to one or more executing device 29, also called tertiary
units.
In most applications it is an advantage if the return spring 27 is
adjustable concerning spring force as well as other spring
characteristics, which in FIG. 4 is indicated by 30, which is a
regulating mechanism. It is even possible to influence the
regulator 30 form outside the body by for example radio
transmission.
FIG. 5 demonstrates an example, where body ventricles of the heart
12 and 17, very schematically, are illustrated and where the left
ventricle 12 via a tube 23a is connected to a secondary unit 24,
which may be a hydraulic motor 24a, while the right ventricle 17,
via the tube 23b, is connected to another hydraulic motor. The
transferal organ 28 is a piston rod connected to a lever 33, which
is part of the regulating mechanism 30, containing the gear
mechanism 32 to be described later under FIG. 15. The generated
energy may be taken out from the tertiary unit 29, which for
example may be an electric generator.
In systolic phase, when the heart contracts, blood is pumped from
both ventricles of the heart 12 and 17 to each its hydraulic
cylinder 24a, and the pistons are pressed back while the return
spring 27 is compressed. In diastolic phase (the relaxation phase
of the heart where the pressure of the ventricles drops) the
pistons are pressed back by the spring 27 and the blood returns to
the heart. Depending on the adjustment of the gear, the quote of
energy extracted from the two ventricles may be varied.
FIG. 6 demonstrates an example where the hydraulic motor 24a is
arranged as a unidirectionally acting pressure box, in the form of
two bellows 37 and 38 connected in series, and with different cross
sectional area resulting in a device working as a differential
piston. The bellows expand longitudinally against a return spring
27 being part of the regulating mechanism. Between the first bigger
bellows 37, connected directly to the ventricle 12 or 17, and the
minor bellows 38 is arranged a pusher plate, being in this example
the transferal organ 28. In the pusher plate is an opening 67,
where a valve 39 is located, which opens in diastole. At the end
plate of the minor bellows 38 is an opening 68 for emptying of the
device with another valve 40. This valve is influenced to open by
the pressurized blood during systolic phase, at the same time as
the return spring 27 is compressed.
In systolic phase, the pressurized blood is transferred from the
ventricle 12/17 to first bellows 37 and to the transferal organ 28.
First valve 39 is closed and bellows 37 expands. At the same time,
blood is transferred from the second bellows 38 via the tube 41 to
the artery 15/20 through the open valve 40. It is noted that the
pressure in systolic phase is bigger in the second bellows 38 than
in the heart 10 and bigger than in the first bellows 37, and that
this difference is proportional to the difference in cross
sectional area between the two bellows.
In diastolic phase, the valve 40 is closed and the return spring 27
will press the transferal organ 28 in return. The valve 39 opens
passively and blood flows from the first bellows 37 to the second
bellows 38, at the same time as blood flows back from the first
bellows 37 to the heart 12/17 through the tube 23.
FIG. 7 demonstrates a pressure amplifier with variable degree of
amplification, which works synchronously with the heart. The
pressure amplifier consists of two hydraulic cylinders connected to
each other with variable gear through the regulating mechanism 30.
One cylinder 24a works as a motor, and the other 24b as a pump. The
hydraulic motor 24a is connected directly to one of the ventricles
12 or 17 and connected to the gear mechanism 30 illustrated in FIG.
15. The pump 24b fills with blood from the same ventricle via the
valve 39 and delivers the blood to the aorta via the tube 44 and
the valve 40. By arranging the cross sectional area of the
cylinders 24a and 24b in the way that the area of the hydraulic
motor 24a is bigger than the one of 24b, and by arranging the gear
of the regulating mechanism 43 in a proper way, one can get
whichever higher pressure in the tube 44 and thereby the intended
pressure amplification.
FIG. 8 demonstrates a counterpulsator intended to accomplish a
mirrored blood pressure curve in an artery and accomplish a
pressure amplification with variable gear. Two piston pumps 24a and
24b are interconnected via the piston rods 28, 34 and a regulating
mechanism 30. One piston pump 24a is directly connected to one of
the ventricles 12 or 17 and the piston pump 24b is connected
directly to the artery 15 or 20. The regulating mechanism 30 may be
adjusted by the regulator 43 (shown in FIG. 15) in the way that the
gear i.e. the length of the levers 33 may be adjusted, and thereby
the pressure of the tube 44 from the piston pump 24b may be varied.
In systolic phase, both piston pumps work as hydraulic motor and
deliver their energy to the return spring 27. In diastolic phase,
the return spring delivers the majority of its energy to 24b, which
then works as a pump. In this example, no valves and no regulating
mechanism are needed. The piston pumps 24a and 24b work in
counterphase with the beats of the heart in the sense that 24a and
24b work as motors when the heart works as a pump (in systolic
phase) but work as pumps when the heart fills with blood (diastolic
phase). This is very important for the arterial mean pressure as
well as for the arterial pressure in diastole, and thereby for the
perfusion of the heart itself (the function of the coronary
circulation) which takes place mainly in diastole.
FIG. 9 illustrates the invention applied for the generation of
electricity. The hydraulic motor 24a is provided with a transferal
organ 28, which transfers its linear movements to the tertiary unit
29 being a linear generator 45. The generator converts the
movements to electricity to be used for influence of other
functions within the organism. No valves are needed and the system
works independent of arrhythmia like for example atrial
fibrillation.
FIG. 10 demonstrates an example of a device for absorption of
energy by transport of blood from the arterial to the venous
system. In this case, the device according to the invention is
located somewhere in the circulation. A shuttle valve 46 is
connected with one port 47 to an artery 50, and with another port
48 to a vein 51. By the function of the shuttle valve it is
possible to load the hydraulic cylinder 24a with pressurized blood,
which opens the first port 47 while the second port 48 is closed
while the spring 49 is compressed. After systolic phase, when the
pressure drops below the force of the spring, the second port opens
and the accumulated blood can be transferred to the vein 51. The
system requires some sort of chock absorption in order to inhibit
resonance disturbances. The tertiary unit 29, powered by the
transferal organ 28, delivers electricity to be used for influence
of other functions within the organism.
FIG. 11 demonstrates a variant of the counterpulsator described in
FIG. 8. This counterpulsator may according to FIG. 11 be connected
at any location of the cardiovascular system in contrast to the one
described in FIG. 8, which presumes an operation on the heart
itself. A shuttle valve 46, which is connected to an artery 15 or
20, will close one port 48 of the valve at each pressure rise
(systole) in the way that the hydraulic pressure can act on the
hydraulic motor 24a. This motor will transmit the movement, via the
gear 30, to the hydraulic pump 24b and the spring 27 will be
compressed. In diastolic phase, the shuttle valve 46 opens and the
blood from the hydraulic motor can return to the system at the same
time as the spring 27 can expand. The hydraulic pump 24b releases
the blood to the actual artery 15 or 20.
FIGS. 12 to 14 demonstrates the pressure curves for the ventricles
in different situations. FIG. 12 illustrates the pressure in a
normal heart without assist. The curve a shows the pressure in the
left ventricle 12, the curve b the pressure in the aorta 15, and
the curve c in the right ventricle. FIG. 13 demonstrates how a
pressure amplifier according to the present invention may
change--increase--the pressure in the aorta 15, while in FIG. 14 it
is demonstrated how a counterpulsator, according to the present
invention, may delay and increase the pressure of the artery. In
both examples given--FIG. 13 and FIG. 14--the size and the profile
of the curve b may be influenced by the regulating mechanism
30.
It is noted that the curve b of FIG. 13 during the complete cardiac
cycle is located at a higher level than the curve a. This
illustrates the unique by this invention and has not been possible
previously without adding energy from outside.
FIG. 15 demonstrates above mentioned complete regulating mechanism
30, which includes a first control unit 31 for limitation of stroke
of for example the piston rod 28 of the hydraulic motor 24a. A
second control unit 32 exists for regulation of the gear between
for example the hydraulic motor 24a and the hydraulic pump 24b, and
a third control unit 35 exists for regulation of settings of the
spring. Depending on the disease and the actual conditions the
regulator 30 may comprise all or only some of the
regulators/sensors.
The individual control units 31, 32 and 35, which are included in
the regulating mechanism 30 according to FIG. 15 are all supplied
with at least one regulator 36a-d. This consists of a fix rail 94
along which a trolley 95 or a slide is displaceable along the rail
94 by help of a motor 96. The trolley 95 has an arm 97 and a
connector 98, which may be varied depending on what the regulator
36 is to be used for.
In the first control unit 31, the connector 98 of the regulator 36a
is performed as a displaceable stop 93, limiting the stroke of the
transferal organ 28 belonging to the hydraulic motor, which may be
a piston rod. In this control unit 31 is included even a sensor of
position 99 and a strain gauge 100.
The purpose of the second control unit 32 is to regulate the gear
between the hydraulic motor 24a of the secondary unit and the
piston pump 24b of the tertiary unit 29 or to regulate the gear
between two secondary units. To do this, a lever 101 is arranged
between the piston rods of the hydraulic motor and the pump. The
pivot point is the connector 98, which is displaceable along the
rail 94 in the way that a variable gear of the force from the
hydraulic motor 24a to the pump 24b can be achieved. The regulation
of the pivot point is performed with the adjusting means 26b.
Depending on the preset parameters of the gear i.e. the pivot point
of the lever 101, the quote of the energy extracted from the two
ventricles may be varied, alternatively, the gear between the
secondary and tertiary unit may be varied.
The third control unit 35, which controls the settings of the
spring, has two adjusting devices 36c and 36d, of which the
connector 98 of the first mentioned device 36c is displaceable
along a spring 27 in order to adjust the tension of the spring.
Using the second adjusting device 36d it is possible to adjust the
zero point of the spring.
The components like the adjusting devices 36 and the sensors 99,100
in the different units 31, 32, 35 are all connected to a
computer.
FIG. 16 gives an example of how the energy extracted from the heart
can be utilized--transformed--for generation of electricity. For
this purpose, the hydraulic motor 24a is connected to an artery
15/20/50 and arranged as a turbine with a magnetic propeller 52
where the majority of the energy of the blood pressing the
propeller is converted to kinetic energy.
The transferal organ 28 consists in this example of a magnet
connector 102, which runs a generator 53. The blood passing the
turbine is returned to a vein 51.
The speed of the turbine can be regulated by means of for example
adjustable flow devices (not given in the figure) and/or by
rotating the wings of the propeller. The rotation energy can if
necessary be stored temporarily by connecting a flywheel to the
turbine shaft.
In some diseases it is necessary to drain compartments of the body
for example the abdomen. This drainage is to day arranged by a tube
passing out of the body through the skin. In FIG. 17 is given a
system where the hydraulic energy of the blood is used to run an
implantable pump 54 connected to a hydraulic rotation motor 24a.
The pump 54 is connected to the actual compartment of the body 56
with a tube 55. The outlet 57 of the pump 54 and the outlet 41 of
the hydraulic motor 24 are both drained to a vein 51. This means
that the drained liquid is returned to the circulation of the body
and a thus a continuous change is established. A valve 42 is
located in the outlet of the pump 54 to inhibit retrograde inflow
of blood to the hydraulic motor, pump and/or abdomen. Even in this
example, the transferal organ 28 is a magnet connector 102 between
the shafts of the turbine and the pump.
The device according to FIG. 18 is to its construction similar to
the example demonstrated in FIG. 8. In this example the device is
used in diseases where the efficiency of the right--or left
ventricle 17, 12 is decreased, by for example an infarction, after
a heart transplantation, a defect in some of the valves or the
like. The hydraulic motor 24a and the piston pump 24b aims to
enhance the emptying of for example the right ventricle in systolic
phase, and to build up a pressure in the pulmonary artery in
diastole.
A device according to the invention can also be used to power an
implantable, or external apparatus for dialysis 61, as demonstrated
in FIG. 19. Since a pressure approximately four times the mean
pressure of the aorta is needed in a dialysis chamber, a pressure
amplification unit 60 is needed, which is connected to the
hydraulic motor 24a, thereby increasing the pressure to dialysis
pressure level. The pressurized blood is transferred from the
pressure amplifier to the blood side 62 of the dialysis device and
thereafter to a suitable vein 51. The water side 63 of the dialysis
device is via a drainage tube 71 connected with an external
collector 64. Alternatively, the drainage tube is connected to the
urinary bladder or to a urostomy (artificial urinary
bladder/opening).
The dialysis apparatus according to the present invention results
in water being lost from the body and this fluid must be replaced.
Normally dialysis fluid of specific composition is added to the
organism through a vein and/or by drinking. Since filtration in a
dialysis filter results in the blood becoming more viscous on its
way through the filter (since dialysed water is eliminated) in some
dialysis apparatus extra dialysis liquid is added before the filter
unit (i.e. predilution), Such predilution will enhance the flow
through the filter.
The device according to FIG. 20 demonstrates a principle
illustration of an automatic pressure amplifier with build in
predilution pump 70. Parallel with the movements of the pressure
amplifier 29, moves a secondary bellows 78, which delivers specific
dialysis liquid through a tube 69, bypassing the valves 39 and 40,
to the high pressure side 62 of the filter unit of the dialysis
device 61. By arranging correct dimensions of the two bellows 38
and 78, a specific predilution of the blood is achieved.
FIG. 21 demonstrates an example where the device of FIG. 8 can be
used as a continuously working counterpulsator but also, preferably
when the patient is at rest, as a generator of electricity 72. This
generator can charge a battery 65 (an electric accumulator),
permitting high energy output when needed. The battery is
preferably located in the way that it may be charged by a charger
66 outside the body near the skin 92. The electrogenerator 72 can
even be run as an electromotor with power from the battery 65 to
assist the heart temporarily when needed. The switch (from
generator to motor) can be facilitated by a detector, for example a
piezeo-electric sensor 83, detecting a certain condition of the
body. At specific changes of such condition, the generator function
is charged to motor function or the opposite. Even an external
signal may be responsible for this change in function mode.
FIG. 22 demonstrates a device according to the invention arranged
as a pressure amplifier 60, in this example implanted in a leg,
connected to an artery 50 to accomplish an enhanced circulation of
a foot.
FIG. 23 demonstrates an additional variant of a counterpulsator
where the hydraulic motor and the executing device 29, i.e. the
pump 24b, consist of concentric bellows 37 and 38 which are
interconnected by a common transferal organ 28--a pusher
plate--located within each other to accomplish a flat
construction.
FIG. 24 demonstrates a variant of the invention where the heart 10
and the secondary unit 24 are connected indirectly. In stead of
having the blood acting on the piston 26 of the hydraulic mtor 24a,
a membrane 79 is arranged as an elastic sack 80, connected to the
heart, and connected to the hydraulic motor. The sack is filled
with an alternative fluid without direct contact to the blood. This
variant can principally be used in all examples, when an indirect
connection is wanted. The membrane in this example located as a
sack in the ventricle, but the membrane can principally be located
in any part of the body where the pump activity of the heart is to
be utilized. Two such examples are given in FIG. 25 and 26.
According to FIG. 25, a second sack 81 has been connected to the
second bellows 38 of the hydraulic motor 24a. This sack 81 is
located within an artery 50 and can there make
contraction--expansion movements.
In the example according to FIG. 26, the secondary unit 24 has been
given a triple function by arranging the hydraulic motor 24a with a
third bellows 78 and a third sack 82. The three systems cooperate
as a counterpulsator taking out energy from both ventricles and
delivering to an artery.
FIG. 27 demonstrates schematically a ventricle 12 or 17 to which is
connected a tube 23. This tube is connected to a secondary unit 24
not to be further specified since its characteristics are
unimportant for the description of this example. The tube 23
includes a fixation device 76, having the form of a cuff preferably
produced by some soft material like for example Teflon. The purpose
of the cuff is fixation of the tube 23 to the heart 10. This
construction is well known within heart surgery. Through the
opening 74 into the heart, where the tube 23 passes, or through the
tube 23 itself, is arranged a catheter 75a, a cable or similar, to
a sensor 75 at the inside of the ventricle 12 or 17 for
continuously monitoring of the volume and pressure conditions of
the ventricle. Such catheters do exist commercially on the marker
like for example catheters of impedance type. It is also possible
to arrange fix sensors 77 at the fixation device itself. Signals
from such sensors are used for regulation of the secondary--and/or
tertiary units 24, 29, sometimes via a processor (a computer) 91,
which may be powered with electricity from a tertiary unit. The
processor 91 is preferably inoperated under the skin 92 in the way
that the accumulator 65 can be charged from a battery charger
located outside the body.
The invention is not limited to above described examples but
several other variants and combinations are possible within the
limits of the patent claims.
The device is not useful in all situations of heart failure. If a
ventricle is little and stiff with a low compliance, the device for
natural reasons cannot extract big volumes from the ventricle and
therefore the absorbed energy is limited. In contrast, the device
can absorb energy from one side of the circulation (left or right)
and give back the energy to the opposite side without blood flow
from one side to the other. This has so far been impossible with
any known pump. The present pump thus can be connected to the
contralaterat side of the heart as well as to the homolateral side.
For natural reasons the extraction of energy from the left side of
the circulation delivered to the right side can be higher and more
powerful since the left side of the heart normally is 5 times as
strong as the right side. But the opposite way around can also be
of significant importance in critically ill patients.
Thus, the energy potentially delivered by the heart may therefore
be: A Be given back to the circulation at the same cycle; B Be
stored and given in return later; C Be converted to electricity and
used within or outside the body; D Be used for the control of
mechanisms of the body itself; E Generate pressure to be used for
running an artificial kidney outside or within the body; F Pump
liquid from one compartment of the body to another; G Pump liquid
from inside the body to the outside--or the opposite; H Operate
valves within or outside the body, to control natural or artificial
openings of the body; I Supply pacemakers or other electric
pulsgenerators like ICD apparatus with power; J Stimulate
peripheral nerves (like for example the rhythm of ventilation); K
Supply implantable computers or similar equipment with energy; L
Supply implantable electric devices with energy, such devices being
in contact with the central nervous system to detect nerve
potentials and computerize these and give signals in return to the
nervous system, other organs or artificial apparatus in the same
area or at a distance in order to facilitate operational functions.
One example may be computers being able to bridge a defect of the
spinal cord or bridge nerves with an interrupted continuity. 10 The
heart 11 Left atrium 12 Left ventricle 13 The mitral valve 14 The
aortic valve 15 The aorta 16 Right atrium 17 Right ventricle 18 The
tricuspid valve 19 The pulmonary valve 20 The pulmonary artery 21
Caval veins 22 Pulmonary veins 23 Connecting tube 24a Secondary
unit 24b Hydraulic motor 25 Volume chamber/cylinder/bellows 26
Piston 27 Spring 28 Transferal organ 29 Tertiary unit/effector
organ 30 Regulator 31 First regulator for stroke 32 Second
regulator of gear 33 Lever 34 Piston rod 35 Third regulator for
preset of spring parameters 36a,b,c,d Regulators 37 First bellows
38 Second bellows 39,40 Unidirectionally functioning valves 41
Connection tube 42 Stop valve 43 Regulator 44 Tube 45 Generator 46
Shuttle valve 47 First opening 48 Second opening 49 Spring 50
Artery 51 Vein 52 Turbine propeller 53 Electric generator 54 Pump
55 Drain tube 56 Compartment of body 57 Outlet from pump 58 Outlet
from hydraulic motor 59 Pusher plate 60 Pressure amplifier 61
Apparatus for dialysis 62 Blood side 63 Water side 64 Container 65
Electric accumulator 66 Charging device 67 First opening 68 Second
opening 69 Tube for predilution water 70 Predilution pump 71 Drain
tube 72 Combined electric-generator/electric-motor 73 Hydraulic
fluid 74 Opening of the heart 75 Device for registration 76 Device
for fixation 77 Sensor 78 Third bellows 79 Membrane 80 First
balloon 81 Second balloon 82 Third balloon 83 Gauge device 90
Electric connector 91 Computer 92 Skin 93 Stop for limitation of
stroke 94 Rail 95 Car 96 Motor 97 Attachment arm 98 Connector 99
Potentiometer 100 Strain gauge 101 Lever 102 Magnetic connector 103
Data communication port 104 Valve 110 Conus
* * * * *