Information
-
Patent Grant
-
6251061
-
Patent Number
6,251,061
-
Date Filed
Wednesday, September 9, 199826 years ago
-
Date Issued
Tuesday, June 26, 200123 years ago
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Inventors
-
Original Assignees
-
Examiners
- Kamm; William E.
- Layno; Carl H.
Agents
- Kelly; Joseph R.
- Westman, Champlin & Kelly, P.A.
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CPC
-
US Classifications
Field of Search
-
International Classifications
-
Abstract
A cardiac assist device and method of use for assisting the function of a heart. The assist device includes a compressor positioned against the epicardial wall of the heart and a field generator for driving a fluid coupled to the compressor to exert pressure on the heart. The field generator may be a magnetic field generator and the fluid coupled to the compressor may be a ferrofluid. The compressor may include two containment regions containing ferrofluid on opposite sides of the heart, and a pair of compression portions coupled to the containment regions. The filled generator may be electromagnetic which includes two electromagnets having corresponding core portions and corresponding coils. The electromagnets may be disposed with their north and south poles in alignment and separated by a gap to allow relative movement. The electromagnets may be external or internal to the body.
Description
BACKGROUND OF THE INVENTION
The present invention deals with a ventricular assist device. More particularly, the present invention deals with cardiomyoplasty using a ferro fluid or other similar fluid.
A number of different types of coronary disease can require ventricular assist. Present ventricular assist devices (VADs) employ mechanical pumps to circulate blood through the vasculature. These pumps are typically plumbed between the apex of the left ventricle and the aortic arch (for LVADs), and provide mechanical assistance to a weak heart. These devices must be compatible with the blood, and inhibit thrombus formation, due to the intimate contact between the pump components and the blood.
Cardiomyoplasty is a form of ventricular assist which includes squeezing the heart from the epicardial surface to assist the ejection of blood from the ventricles during systole. This form of ventricular assist does not require contact with blood or surgical entry into the cardiovascular system. It has been expressed in several embodiments over the years. The first involves an approach which is drastically different from the mechanical pump approach discussed above. The approach uses a muscle in the patient's back. The muscle is detached and wrapped around the epicardium of the heart. The muscle is then trained to contract in synchrony with the ECG pulse, or other pulse (which may be generated by a pacemaker). Since the back muscle does not contact blood, many of the issues faced by conventional LVADs are avoided. However, this approach also suffers from disadvantages, because operation of the muscle tissues is poorly understood and largely uncontrolled.
A number of other methods are also taught by prior references. Some such references disclose balloons or bellows which squeeze on the exterior surface of the heart in synchrony with the ECG signal. U.S. Pat. No. 3,455,298 to Anstadt discloses an air pressure source which is used to inflate a balloon about a portion of the external surface of the heart, in order to provide a squeezing pressure on the heart.
Other references disclose similar items which are inflated using fluid inflation devices. Still other references disclose mechanical means which apply pressure radially inwardly on the epicardial surface of the heart. For instance, U.S. Pat. No. 4,621,617 to Sharma discloses an electromechanical mechanism for applying external pressure to the heart.
The air and fluid inflation devices exhibit certain advantages in that they use conformable fluids to provide an atraumatic squeezing force on the surface of the heart, as opposed to mechanical and electromechanical devices which use rigid surfaces, which contact the heart, in order to exert the squeezing force. However, one disadvantage of the fluid devices is the need for a pump which delivers fluid from a reservoir. The pump and the associated electronics is generally bulky, and can be too large and cumbersome to be implanted within the patient. Thus, such devices often require the patient to remain in bed while the device is in use.
Further, while the human muscle wrap approach does address some of these problems, it requires radical surgery plus the training of the muscle, which may not always be accomplished successfully.
SUMMARY OF THE INVENTION
The present invention is directed to a cardiac assist device for assisting the function of a heart. The assist device includes a compressor positioned against the epicardial wall of the heart and a field generator for driving a fluid coupled to the compressor to exert pressure on the heart. The pressure exerted against the heart improves heart function.
The field generator may be a magnetic field generator and the fluid coupled to the compressor may be a ferrofluid. The magnetic field generator may include an electromagnet having a core and an energizeable coil disposed thereabout. The ferrofluid may be disposed proximate a gap in the electromagnet such that the compressor exerts a force against the heart wall by generation of a magnetic field in the gap.
The compressor may include two containment regions containing ferrofluid on opposite sides of the heart, and a pair of compression portions coupled to the containment regions. The electromagnet may include two electromagnets having corresponding core portions and corresponding coils. The electromagnets may be disposed with their north and south poles in alignment and separated by a gap to allow relative movement. The electromagnets may be external or internal to the body.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1
illustrates a partial sectional view of a human heart and its associated proximate vascular system.
FIG. 2
is a diagrammatic illustration, in partial schematic form, of an assist device in accordance with one aspect of the present invention.
FIG. 3
is a top view of the device shown in FIG.
2
.
FIGS. 4A-4C
illustrate an assist device in accordance with another aspect of the present invention.
FIGS. 5A-5C
illustrate an assist device in accordance with another aspect of the present invention.
FIGS. 6A-6C
illustrate an assist device in accordance with another aspect of the present invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
FIG. 1
illustrates a partially sectioned view of a human heart
20
, and its associated vasculature. The heart
20
is subdivided by muscular septum
22
into two lateral halves, which are named respectively right
23
and left
24
. A transverse constriction subdivides each half of the heart into two cavities, or chambers. The upper chambers consist of the left and right atria
26
,
28
which collect blood. The lower chambers consist of the left and right ventricles
30
,
32
which pump blood. The arrows
34
indicate the direction of blood flow through the heart. The chambers are defined by the epicardial wall of the heart.
The right atrium
28
communicates with the right ventricle
32
by the tricuspid valve
36
. The left atrium
26
communicates with the left ventricle
30
by the mitral valve
38
. The right ventricle
32
empties into the pulmonary artery
40
by way of the pulmonary valve
42
. The left ventricle
30
empties into the aorta
44
by way of the aortic valve
46
.
The circulation of the heart
20
consists of two components. First is the functional circulation of the heart
20
, i.e., the blood flow through the heart
20
from which blood is pumped to the lungs and the body in general. Second is the coronary circulation, i.e., the blood supply to the structures and muscles of the heart
20
itself.
The functional circulation of the heart
20
pumps blood to the body in general, i.e., the systematic circulation, and to the lungs for oxygenation, i.e., the pulmonic and pulmonary circulation. The left side of the heart
24
supplies the systemic circulation. The right side
23
of the heart supplies the lungs with blood for oxygenation. Deoxygenated blood from the systematic circulation is returned to the heart
20
and is supplied to the right atrium
28
by the superior and inferior venae cavae
48
,
50
. The heart
20
pumps the deoxygenated blood into the lungs for oxygenation by way of the main pulmonary artery
40
. The main pulmonary artery
40
separates into the right and left pulmonary arteries,
52
,
54
which circulate to the right and left lungs, respectively. Oxygenated blood returns to the heart
20
at the left atrium
26
via four pulmonary veins
56
(of which two are shown). The blood then flows to the left ventricle
30
where it is pumped into the aorta
44
, which supplies the body with oxygenated blood.
The functional circulation, however, does not supply blood to the heart muscle or structures. Therefore, functional circulation does not supply oxygen or nutrients to the heart
20
itself. The actual blood supply to the heart structure, i.e., the oxygen and nutrient supply, is provided by the coronary circulation of the heart, consisting of coronary arteries, indicated generally at
58
, and cardiac veins. Coronary artery
58
resides closely proximate the endocardial wall of heart
24
. The coronary artery
58
includes a proximal arterial bed
76
and a distal arterial bed
78
downstream from the proximal bed
76
.
In order to assist the heart, the present invention provides a fluid either partially surrounding the heart, or completely surrounding the heart, wherein the fluid can be influenced by electric or magnetic fields. The fluid is located closely proximate the epicardial surface of the heart and is influenced by the application of an electric or magnetic field in order to assist the heart.
FIG. 2
is a diagram, in partial schematic form, illustrating cardiomyoplasty system
100
which is used, in accordance with one aspect of the present invention, in order to assist the heart
20
. In system
100
, heart
20
is illustrated surrounded by a bag
102
which is substantially, or partially, filled with a ferrofluid (shown in FIG.
3
). System
100
also includes electromagnet sections
104
and
106
which are coupled, through switches
108
and
110
, to a power supply
112
. Switches
108
and
110
are controlled by controller
114
which, in one preferred embodiment, receives an ECG input signal from heart rate sensor or monitor
116
.
In one preferred embodiment, bag
102
is formed of a non-compliant balloon material which is preferably attached to portions of the heart by sutures, indicated generally at
118
. Bag
102
is filled with a ferrofluid which, in one preferred embodiment, is paramagnetic in that it becomes magnetic in the presence of an applied magnetic field. Such fluids are commercially available from Ferrof luidics Corporation, 40 Simon Street, Nashua, N.H. 03061, and Lord Corporation, 405 Gregson Drive, Cary, N.C. 27511. The fluid is preferably biocompatible and includes suspensions of small, ferromagnetic particles. In zero applied field, the fluid is non-magnetic. However, the fluid becomes magnetized when an external magnetic field is applied. The maximum magnetization which can occur in the fluid is referred to as the saturation induction, and is typically achieved in applied fields of about 1000 Oersteds, and has typical values of about 1000 Gauss. Applied fields in this range, and higher, can be achieved with electromagnets using conventional core materials and fairly modest electrical power.
The ferrofluids surrounding the heart are energized by magnetic fields which can originate from electric currents or permanent magnets situated either within or outside the body. For example, the magnetic fields in
FIG. 2
are generated by electromagnets
104
and
106
located outside the body. Electromagnets
104
and
106
each include a coil
120
and
122
, respectively which is formed, illustratively, of insulated copper wire. Coils
120
and
122
are wound around thin sheets of magnetic material
124
and
126
, respectively. The material
124
and
126
, in one preferred embodiment, is commercially available under the commercial designation Hiperco, from Carpenter Metals, of Reading, Pa. In the embodiment illustrated in
FIG. 2
, electromagnets
104
and
106
are generally semi-circular in shape, and are each configured as half torroids set up in a repulsion configuration.
Coils
120
and
122
are coupled to power supply
112
(which in one preferred embodiment is a battery) through switches
108
and
110
, which are controlled by controller
114
. A bipolar ECG lead
130
is attached at a point on the patient's chest and provides a signal to heart rate sensor
116
which, in turn, provides a signal to controller
114
indicative of the activity of heart
20
. Controller
114
controls switches
108
and
110
to selectively energize coils
120
and
122
during systole.
When current is passed through coils
120
and
122
, in the direction indicated, a magnetic field is directed through the chest of the patient from the north poles (indicated by the letter N in
FIG. 2
) to the south poles (indicated by the letter S in
FIG. 2
) of coils
120
and
122
. This field magnetizes the ferrofluid within bag
102
and forces it to a center line (designated by dashed line
132
) between electromagnets
104
and
106
, in the direction indicated by arrows
134
and
136
. Energization of electromagnets
104
and
106
also forces the ferrofluid in bag
102
toward the north and south poles in the direction generally indicated by arrows
138
and
140
. Bag
102
reacts in this way because a force develops which pulls the ferrofluid to the point of the strongest field concentration within system
100
.
As the field is applied, bag
102
, under the force of the ferrofluid driven by the magnetic field, is squeezed inwardly and flattened. The force is proportional to the area of the ferrofluid. Only a few pounds per square inch (psi) are required to pump the blood from within heart
20
. This can be achieved when only a few Watts of power are delivered to coils
120
and
122
. The amplitude of the coil current controls the pressure exerted by the bag
102
of ferrofluid. Of course, the magnitude of the current can be adjusted until the patient's blood pressure is within a normal range.
In one illustrative embodiment, electromagnets
104
and
106
are contained within a vest worn about the chest of the patient. Also, magnetic shields
142
are provided to cover the region of the gap between the semi-circular magnets, both on the North Pole and South Pole ends, and reside on the outside surface, away from the patient. Magnetic shield
142
confines the high magnetic field to a region within the patient's chest.
FIG. 3
is a top view of a portion of system
100
shown in FIG.
2
. In
FIG. 3
, bag
102
is shown as having a pair of generally oppositely disposed pouches
146
and
148
which are connected by bands
150
and
152
which extend about, and are sutured to heart
20
. Pouches
146
and
148
contain the ferrofluid material. Thus, when the magnetic field is applied, pouches
146
and
148
are pulled in generally opposite directions toward the north and south poles, respectively. This tends to flatten bag
102
about heart
20
. Since pouches
146
and
148
generally reside closer to the north and south poles, this provides more efficient magnetic coupling between those poles and the ferrofluid residing in pouches
146
and
148
.
Of course, a wide variety of other bag configurations can be used as well. For example, instead of having two discrete pouches, bag
102
can be formed having a single pocket which extends about the entire periphery of heart
20
, bag
102
can be formed having a number of separately divided pockets which extend about the periphery of heart
20
. Further, bag
102
may preferably be formed with seams
119
which are disposed about regions having larger coronary vessels
121
in order to avoid compressing those vessels during energization of the coil. Other, different bag configurations can be used as well.
FIGS. 4A-4C
illustrate a cardiac assist system
200
in accordance with another aspect of the present invention. A number of other items in system
200
are similar to those in system
100
illustrated in
FIGS. 2 and 3
, and are similarly numbered. However, system
200
is substantially entirely implantable. System
200
includes a plurality of electromagnets
202
,
204
, and
206
. Each electromagnet includes a core
208
surrounded by a coil
210
. Each of the coils
210
is coupled to a corresponding switch
212
,
214
, or
216
, which is controlled by controller
114
based on an ECG or other suitable signal, and selectively couples coils
210
to battery
112
. As with system
100
, the cores
208
of the electromagnets are preferably a Hiperco or other suitable core material surrounded by coils
210
, which is preferably formed of insulated silver or gold wire. All circuitry is preferably implantable, and battery
112
is preferably inductively recharged from outside the body.
The plurality of electromagnets
202
,
204
and
206
are separated by gaps
220
. Thus, the electromagnets form torroids which substantially surround the heart, but which are split into a plurality of sections which define magnetic gaps
220
. Each of the gaps contains two bags
222
and
224
, which are separated by a septum
226
. In one preferred embodiment, bags
222
are disposed in a direction radially toward the epicardial wall of heart
20
, while bags
224
are disposed in an opposite direction.
Bags
222
are filled with non-magnetic fluid, while bags
224
are filled with ferrofluid. When current is applied to the torroidal coils during systole, each ferrofluid bag
224
is drawn into a corresponding gap
220
, thus exerting an inwardly directed force on bags
222
and thus on the epicardial wall of heart
20
. This force displaces the non-magnetic fluid against the heart wall. During diastole, the coils are de-energized and expansion of heart
20
advances bag
222
back into gaps
220
and thus displaces the ferrofluid in bag
224
, out of gap
220
. Bags
222
and
224
thus mimic the action of fingers performing heart massage.
In accordance with one aspect of the present invention, gaps
220
are narrower at the apex of heart
20
and wider toward the top of the heart
20
. Since the gaps are narrower at the apex, the magnetic field in the narrower gap region is stronger than at the top of heart
20
. This causes pressure to build, once the coils are energized, from the apex upward in a natural progression to assist displacement of blood from left ventricle
30
. In addition, as illustrated in
FIG. 4A
, bags
222
and
224
are formed in gaps
220
substantially about the left ventricle
30
of heart
20
, while no gaps are preferably defined by the electromagnets about right ventricle
32
. This preferentially exerts pressure to assist in displacement of blood from left ventricle
30
.
FIGS. 4B and 4C
illustrate the action of one set of bags
222
and
224
under the influence of the magnetic field exerted by the electromagnets
204
and
206
. It will be appreciated that similar action will take place in each of the gaps
220
.
FIG. 4B
illustrates that the coils on electromagnets
204
and
206
are energized during systole to create a magnetic field in gap
220
. The magnetic field draws the ferrofluid in bag
224
into the gap, thus displacing the non-magnetic fluid in bag
222
inwardly toward heart
20
. By contrast, when the magnets are de-energized during diastole, the heart chambers fill thus exerting a pressure on bag
222
which displaces the ferrofluid in bag
224
from gap
220
, radially outwardly, to allow expansion of the heart
20
.
FIGS. 5A-5C
illustrate a portion of another assist system
300
in accordance with another aspect of the present invention. As with systems
100
and
200
, a heart rate monitor
116
, a controller
114
, a plurality of switches, and implantable battery
112
are preferably provided in system
300
, although they are not illustrated for the sake of clarity. In system
300
, a torroidal electromagnet
302
includes a core member
304
, which is preferably formed of Hiperco material, and winding
306
, which is preferably formed of insulated silver or gold wire. To improve flexibility of the electromagnet, the core may consist of a flat bag of ferrofluid. Core member
304
is disposed about the epicardial layer of heart
20
and defines a gap
308
between ends thereof. Core member
304
is also preferably sutured to heart
300
in two or more locations generally indicated by numeral
310
. The areas at which core
304
is sutured to the epicardial wall of heart
20
are preferably proximate left ventricle
30
.
System
300
also preferably includes a bag
312
of ferrofluid material. Bag
312
includes a plurality of separate pouches
314
, each of which form an elongate finger containing ferrofluid material. Bag
312
is preferably sutured to the epicardial layer of heart
20
in gap
308
. The current in coil
306
is preferably driven by an implanted battery, and is switched on during the heart's systolic phase. The beginning of systole can be sensed in several different ways, including by using the QRS complex on an ECG electrode planted on the heart, by using the heart sound produced when the aortic valve opens and sensed by an implanted microphone, or by using a preset pressure threshold as measured on or in the left ventricle. The current through coil
306
is switched off when the T-wave of the ECG signal is identified, when the aortic valve is heard closing, or when the pressure drops below a valve closing threshold.
When coil
306
is energized, the end portions of core
304
tend to move toward one another in the directions generally indicated by arrows
316
and
318
, in order to close gap
308
. This causes a squeezing on heart
20
in the direction indicated by arrows
316
and
318
.
In addition, pouches
314
, containing ferrofluid, are preferably centered longitudinally in gap
308
, but are radially displaced on the left ventricle
30
outward from the plane of gap
308
when not under the influence of a magnetic field. The ferrofluid in pouches
314
is positioned to partially close the magnetic circuit in gap
308
. Thus, when coil
306
is energized, the ferrofluid is drawn radially inward, in the direction indicated by arrows
320
, as gap
308
is closing generally tangentially. Thus, left ventricle
30
is receiving a squeezing force in two directions, which enhances the efficiency of the cardiac assist.
It should also be noted that sutures
310
are preferably formed in a region of left ventricle
30
, or approximately on a line dividing left ventricle
30
from right ventricle
32
. Thus, only left ventricle
30
is squeezed. The sutures maintain a gap between electromagnet
302
and the epicardial wall of heart
20
in the area of right ventricle
32
. Thus, right ventricle
32
does not receive any of the squeezing force. Of course, without sutures
310
, both left ventricle
30
and right ventricle
32
could be squeezed.
FIGS. 5B and 5C
are top views of system
300
illustrating the operation thereof. In
FIG. 5B
, coil
306
is de-energized, such that gap
308
is larger and pouches
314
are radially displaced, somewhat, from gap
308
. However, upon energization of coil
306
, gap
308
tends to close in the direction indicated by arrows
316
and
318
, and pouches
314
tend to move radially inwardly, into gap
308
, in the direction indicated by arrows
320
.
FIG. 5C
illustrates system
300
after coil
306
is energized. Note that gap
308
has closed somewhat, and pouches
314
are now more closely drawn within gap
308
, thus squeezing left ventricle
30
.
It should be noted that, in
FIGS. 5A-5C
, and in accordance with one aspect of the present invention, core
304
is made from a plane of individual Hiperco wires overwound with AWG #25 copper wire. This entire structure is only approximately 0.048 inches thick, and is quite flexible, especially when held together by a flexible adhesive, such as urethane. The structure is wrapped around heart
20
, and sutured. The ends defining gap
308
are softened with a urethane coating. Flexibility can also be achieved by making the magnetic core from a flat bag of ferrofluid. Alternatively, the torroid is made of a more rigid structure which is shaped to fit snugly about heart
20
, without sutures. In such an embodiment, only the magnetically permeable material in bag
312
moves under the influence of the magnetic force, while the ends of the torroid do not close.
Also, in the embodiment shown in
FIGS. 5A-5C
, the coil resistance of the torroidal coil is approximately 6.5 ohms with a maximum current rating of 1 amp. The average heat dissipation required to generate desirable compressive force is approximately 3.3 watts, with an efficiency of 55% (i.e., 4 watts of pumping power).
FIGS. 6A-6C
illustrate another system
400
in accordance with another aspect of the present invention. System
400
includes a rigid structure or frame
402
, which has a bag
404
partially filled with ferrofluid material, supported thereby. In one embodiment, bag
404
is adhered to structural frame
402
. The structural frame
402
is formed of non-magnetic material, such as structural plastic, and structure
402
and bag
404
are overwound with a copper coil
406
.
The density of the windings is greater in a region proximate left ventricle
30
than in the region proximate right ventricle
32
. In one preferred embodiment, the density in the region of left ventricle
30
is double that in the region of right ventricle
32
. For example, in a region of structure
402
proximate right ventricle
32
, coil
406
includes N windings per unit length. However, in a region of structure
402
proximate left ventricle
30
, coil
406
includes more windings, such as 2N windings. It should also be noted that bag
404
is disposed on the outside of rigid structure
402
in the area proximate right ventricle
32
, but is disposed on the inside surface of structure
402
in the area proximate left ventricle
30
. In accordance with one aspect of the present invention, structure
402
includes a transition section
408
which forms a gap between two longitudinally separated rails
410
and
412
. The bag passes from the outer surface of structure
402
to the inner surface thereof through gap
408
.
The conductive windings, in one embodiment, are physically attached to the surface of bag
404
, and the wires are quite flexible. In another embodiment, where the wires are more rigid, the wires are not attached to the surface of balloon
404
, but are instead simply draped over the surface of bag
404
. Further, in addition, the windings of coil
406
are physically attached to the outside of structure
402
in the area proximate left ventricle
30
, and are physically attached to the inside of structure
402
in the area proximate right ventricle
32
.
As with previous embodiments, one or more switches are provided to alternately couple coil
406
to a power supply
112
under the control of a controller
114
. In addition, a heart rate sensor
116
can also be provided to provide an input to the control circuitry such that the coil can be energized in synchronicity with the heart action.
Initially, balloon
404
is evacuated and partially re-filled with ferrofluid. When coil
406
is energized, the ferrofluid is forcibly moved within balloon
404
to the region around left ventricle
30
, because the greater density of windings in coil
406
in that region produces a stronger magnetic field. This preferentially fills balloon
404
proximate left ventricle
30
and thereby exerts a compression force on the epicardial surface of heart
20
in the region of left ventricle
30
. However, even when the coil is energized, there is still enough ferrofluid in the remainder of balloon
404
in the region around right ventricle
32
to complete the torroidal magnetic circuit throughout the entire circumference of heart
20
.
During diastole, the left ventricle
30
expands, and coil
406
is de-energized. The ferrofluid within balloon
404
is thus displaced from the left ventricle side of balloon
404
to the right ventricle side of balloon
404
where it occupies space outside of the volume of heart
20
. When the right ventricle side of balloon
404
is fully inflated, there is still enough ferrofluid left on the left ventricle side of balloon
404
to make a complete magnetic circuit, once coil
406
is re-energized.
FIGS. 6B and 6C
are top views of system
400
shown in FIG.
6
A. In
FIG. 6B
, system
400
is shown with coil
406
energized during systole. It can be seen that balloon
404
preferentially fills on the side of heart
20
proximate left ventricle
30
, to exert compressive force in the direction generally indicated by arrow
420
on the epicardial surface of heart
20
. However, during diastole, and as shown in
FIG. 6C
, left ventricle
30
fills thus displacing ferrofluid from the left ventricle side of bag
404
, causing it to be displaced to a position outside structure
402
to the right ventricle side of balloon
404
.
It should also be noted that, system
400
shown in
FIGS. 6A-6C
can be sutured to the epicardial surface of heart
20
at any desirable location. For example, structure
402
can be sutured to a region of epicardial surface of heart
20
proximate the division between left ventricle
30
and right ventricle
32
. In this way, as balloon
404
fills, it exerts a backpressure on the rigid structure causing balloon
404
to expand inwardly and thus compress left ventricle
30
, without exerting any pressure on right ventricle
32
. In addition, during diastole, the ferrofluid falls under the force of gravity to the region of balloon
404
proximate the apex of the heart, and to the lower, posterior side of the heart, which is tilted back in the chest cavity. When current is applied to coil
406
, the apex region of the heart will be squeezed first, forcing the blood up and out of the heart in a natural contractile motion.
Thus, it can be seen that the present invention provides significant advantages over prior systems. The present invention need not be as compatible and deal with thrombus formation issues as required by systems which are deployed within the heart. Similarly, the present invention does not require external fluid sources for selectively filling a bag or pouch with fluid in order to exert compression on the heart. In addition, the present invention does not deal with natural muscle fibers wrapped around the heart, and thus does not encounter the difficulties associated with such techniques. Also, the present invention exerts a pressure on the heart with a pliable fluid filled surface which yields an atraumatic compressive force on the heart, as opposed to a traumatic compressive force encountered during compression with a rigid mechanical structure.
Although the present invention has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention.
Claims
- 1. A cardiac assist device for assisting function of a heart, comprising:a compressor disposed proximate an epicardial wall of the heart; a magnetic field generator comprising an electromagnet, the electromagnet having a core defining a gap and an energizable coil disposed about the core, the field generator configured to selectively generate a field; and a ferrofluid operably coupled to the compressor and positioned to be driven, in response to generation of the field, to a compressor position in which the ferrofluid drives the compressor to exert pressure on the heart.
- 2. The device of claim 1 wherein the ferrofluid is disposed proximate the gap to be driven to the compressor position by generation of the magnetic field in the gap.
- 3. The device of claim 2 wherein the compressor comprises:first and second containment regions disposed on generally opposite sides of the heart, each containment region containing ferrofluid; and a pair of compression portions coupled to the first and second containment regions and disposed on generally opposite sides of the heart.
- 4. The device of claim 3 wherein the electromagnet includes:first and second electromagnets having first and second core portions with corresponding first and second coils, the first and second electromagnets being disposed with north poles and south poles thereof generally in alignment, and separated from one another to form the gap.
- 5. The device of claim 4 wherein the first and second containment regions are configured to be drawn toward the north and south poles, respectively, in response to energization of the first and second electromagnets, such that the compression portions exert a compressive force on the heart.
- 6. The device of claim 5 wherein the first and second electromagnets are external to a body containing the heart.
- 7. The device of claim 3 wherein the pair of compression portions are fixedly connected to the heart.
- 8. The device of claim 2 wherein the electromagnet comprises an implantable core portion disposed about the heart and a coil portion wound about the core portion, the core portion defining a gap, and wherein the compressor comprises:a first container containing a nonmagnetic fluid and coupled to the core proximate the gap; and a second container containing the ferrofluid and coupled to the core proximate the gap and radially displaced further from the heart than the first container.
- 9. The device of claim 8 wherein the first and second containers are configured such that when the electromagnet is de-energized, normal heart action drives the first container radially outwardly, substantially displacing the second container from the gap, and wherein energization of the electromagnet drives the second container into the gap, substantially displacing the first container from the gap exerting pressure on the heart.
- 10. The device of claim 2 wherein the gap is generally aligned with a longitudinal axis of the heart and is narrower at a portion thereof proximate an apex of the heart than at a longitudinally upper portion thereof.
- 11. The device of claim 9 wherein the electromagnet includes a plurality of core portions each with a corresponding coil, the plurality of core portions defining a plurality of gaps, each gap having one of the first containers and the second containers positioned proximate thereto.
- 12. The device of claim 2 wherein the electromagnet is implantable and coupled to the heart and wherein the compressor comprises a container containing the ferrofluid coupled to the heart and disposed proximate the gap such that energization of the coil draws the container radially within the gap to exert a compressive force on the heart.
- 13. The device of claim 12 wherein the electromagnet is coupled to the heart such that the gap is proximate the left ventricle and such that the core is radially separated from the heart in an area proximate the right ventricle.
- 14. The device of claim 2 wherein the compressor comprises:a plurality of containment regions disposed about the heart, each containment region containing ferrofluid.
- 15. The device of claim 14 wherein the plurality of containment regions are generally aligned with a longitudial axis of the heart.
- 16. The device of claim 2 wherein the compressor is adapted to drive the ferrofluid away from the heart to the compressor position.
- 17. A cardiac assist device for assisting function of a heart, comprising:a compressor disposed proximate an epicardial wall of the heart; a monitor configured to detect a rhythm of the heart; a field generator coupled to the monitor and configured to selectively generate a field based on the rhythm detected by the monitor; and a fluid operably coupled to the compressor and positioned to be driven, in response to generation of the field, to a compressor position in which the fluid drives the compressor to exert pressure on the heart.
- 18. A cardiac assist device for assisting function of a heart, comprising:a compressor disposed proximate an epicardial wall of the heart; a field generator configured to selectively generate a field of variable strengths, varying about a periphery of the heart; and a fluid operably coupled to the compressor and positioned to be driven, in response to generation of the field, to a compressor position in which the fluid drives the compressor to exert pressure on a side of the heart in accordance with the field strength.
- 19. A cardiac assist device for assisting function of a heart, comprising:a compressor disposed proximate an epicardial wall of the heart; a field generator comprising an electromagnet having a core and an energizable coil disposed thereabout configured to selectively generate a field; and a ferrofluid arranged to act as the core and operably coupled to the compressor and positioned to be driven, in response to generation of the field, to a compressor position in which the ferrofluid drives the compressor to exert pressure on the heart.
- 20. A cardiac assist device for assisting function of a heart, comprising:a compressor disposed proximate an epicardial wall of the heart; an electric field generator configured to selectively generate a field; and a dielectric fluid operably coupled to the compressor and, positioned to be driven, in response to generation of the field, to a compressor position in which the fluid drives the compressor to exert pressure on the heart.
- 21. A cardiac assist device for assisting function of a heart, comprising:a compressor disposed proximate an epicardial wall of the heart; a magnetic field generator configured to selectively generate a magnetic field, the magnetic field generator comprising: a structural support disposed about the heart; a container coupled to the structural support; and a coil disposed about the container and coupled to the structural support; and a ferrofluid contained in the container operably coupled to the compressor and positioned to be driven, in response to generation of the field, to a compressor position in which the ferrofluid drives the compressor to exert pressure on the heart.
- 22. The device of claim 12 wherein the container is disposed radially outside the structural support in a region proximate the right ventricle.
- 23. The device of claim 21 wherein the container is disposed radially inside the structural support in a region proximate the left ventricle.
- 24. The device of claim 21 wherein the coil is configured to, when energized, generate a magnetic field which preferentially draws the ferrofluid to a portion of the container proximate the left ventricle.
- 25. The device of claim 24 wherein the coil has a winding density which is higher in a region proximate the left ventricle than in a region proximate the right ventricle.
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