U.S. patent number 3,641,591 [Application Number 05/009,307] was granted by the patent office on 1972-02-15 for soft shell mushroom shaped heart.
This patent grant is currently assigned to University of Utah. Invention is credited to Willem J. Kolff.
United States Patent |
3,641,591 |
Kolff |
February 15, 1972 |
**Please see images for:
( Certificate of Correction ) ** |
SOFT SHELL MUSHROOM SHAPED HEART
Abstract
The output volume of the artificial heart of this invention is
highly responsive and directly proportional, within limits, to the
atrial filling pressure of the blood flowing into the pumping
chamber of the artificial heart. Flexible wall construction is
responsible for the output volume being a function of the inlet
pressure and also serves to reduce tissue damage to the surrounding
body organs when the artificial heart is placed in the same general
locality as that usually occupied by the natural heart. An integral
valve means operable in conjunction with an inflatable blood
displacement member occludes the inlet to the heart during the
pumping phase of the heart.
Inventors: |
Kolff; Willem J. (Salt Lake
City, UT) |
Assignee: |
University of Utah
(N/A)
|
Family
ID: |
21736851 |
Appl.
No.: |
05/009,307 |
Filed: |
February 6, 1970 |
Current U.S.
Class: |
623/3.21;
128/897 |
Current CPC
Class: |
A61M
60/894 (20210101); A61M 60/898 (20210101); A61M
60/892 (20210101); A61M 60/148 (20210101); A61M
60/122 (20210101); A61M 60/268 (20210101); A61M
60/40 (20210101) |
Current International
Class: |
A61M
1/10 (20060101); A61M 1/12 (20060101); A61f
001/24 () |
Field of
Search: |
;128/1R,214,DIG.3
;3/1,DIG.2 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Primary Examiner: Truluck; Dalton L.
Claims
I claim:
1. A blood pumping device to replace or temporarily assist the
natural heart, said device comprising:
a. a blood pumping chamber of flexible wall construction, and
having separate blood inlet and outlet means; and
b. an inflatable blood displacement member of elastic wall
construction located within said pumping chamber and operable upon
periodic inflation to forcibly eject blood from said pumping
chamber through said outlet means, an inflatable valve head for
periodically blocking said inlet means, said valve head being
affixed to said displacement member and operable as a valving
means, said valve head including means for operating said valve
head separately from said inflation of said inflatable blood
displacement member to thereby achieve optimum pumping efficiency
of said blood pumping device.
2. A blood pumping device as defined in claim 1 wherein the
external configuration of the pumping device conforms substantially
to that of a natural human heart.
3. A blood pumping device as defined in claim 1 wherein said
flexible wall construction of the pumping chamber is restrained
from expansion beyond predetermined limits by a nonelastic but
flexible restraining surface.
4. A blood pumping device as defined in claim 3 wherein the elastic
wall construction of the pumping member is operable to completely
distend the elastic walls of the pumping chamber to the restraining
limits of the restraining surface even in the presence of a
differential amounts of blood in the blood pumping chamber at any
given time.
Description
In developing of an artificial heart pumping device to replace or
assist a natural heart, it is desirable for the output volume of
the artificial heart to be responsive to and substantially directly
proportional to the blood input pressure. It is estimated that the
atrial filling pressure to the natural heart is responsible for
approximately 80 percent of the control of the output volume of the
heart in response to body needs. This concept has been amply
demonstrated by natural heart transplants wherein all the nerves to
the transplanted heart have been severed and yet the transplant
heart continues to function adequately. Regulation of the pumping
output capacity of the artificial heart as a function of body needs
is one of the problems to be overcome in producing an artificial
heart for placement in the chest cavity of a human being. Numerous
attempts have been made to make the artificial heart responsive to
the needs of the body through means of pressure sensors or other
sensing elements which cause either speed up or slow down of the
pumping action of the artificial heart. The relationship between
output volume and inlet pressure is known as Starling's Law and is
one of the important considerations in the design of an artificial
heart since this relationship will prevent the collapse of inlet
blood vessels from an oversuction by the pumping chamber or blood
pooling from insufficient output volume. To be responsive to
Starling's Law, it is necessary for the volume or capacity of the
pumping chamber to change in direct proportion to the inlet or
filling pressure of blood entering the pumping chamber. Prior
attempts to design an artificial heart have generally been
unsuccessful since the inlet pressure responsive areas of the
pumping chamber which change the capacity of the pumping chamber
with corresponding changes in inlet pressure are usually too small
and intricate to be effective. Some of these inlet pressure
responsive devices are in the form of bellows which, in turn,
create other problems such as crowding in an already congested area
and reduction of usable pumping volume.
Further restrictions to the usefulness of prior modifications of an
artificial heart are in the external design and materials of
construction. The external configuration is usually grossly
dissimilar to that of a natural heart. They are also generally
constructed of a rigid material which causes considerable damage to
surrounding tissue when the artificial heart is placed in the same
general vicinity as that usually occupied by a natural heart.
In the present embodiment of the natural heart, the blood pumping
chamber is defined as the area between a flexible external wall of
the artificial heart and an inflatable pumping member inside the
heart. Blood is forced from the pumping chamber by the inflation of
the pumping member. The direction of flow of the blood is
appropriately controlled by valves in inlet and outlet conduits.
The inlet valve to the pumping chamber is formed as an integral
part of the pumping member thus giving rise to the name "Mushroom
Heart" since the valve comprises the head or button of the mushroom
and the pumping member is the stem. The inlet blocking member or
valve head acts in a manner similar to a ball valve since the valve
head is formed as an extension of the pumping member and is
comprised of an inflatable membrane having a surface which contacts
the periphery of the inlet opening to the pumping chamber to
occlude the inlet when the valve is inflated. Inflation of the
valve is accomplished either simultaneously with the inflation of
the pumping member or separately as desired to achieve optimal
pumping efficiency.
The flexible external wall is restrained from flexing beyond
certain limits by a nonelastic but flexible restraining surface
such as a netting material either incorporated into the external
wall or located exteriorily thereto. In circumstances where the
restaining surface hinders the necessary flexibility of the
external wall, it is suggested that the two surfaces not be joined
but operate independently of each other.
Therefore, it is an object of this invention to provide an
artificial heart which is similar in size and external shape to a
natural heart.
It is a further object of this invention to provide an artificial
heart of flexible external construction.
It is a still further object of this invention to provide an
artificial heart which is responsive in its pumping output to the
filling pressure of the artificial heart.
It is a still further object of this invention to provide an
artificial heart with an integral valve means closely connected
with the pumping member to provide a means for occluding the inlet
to the heart pumping chamber during the pumping phase for the
prevention of the reverse flow of blood.
These and other objects of this invention will become obvious when
viewed in conjunction with the following description and drawings
in which:
FIG. 1 is a cross-sectional schematic of the soft shell mushroom
heart during the inlet phase of blood into the pumping chamber of
the artificial heart;
FIG. 2 is a cross-sectional schematic of the soft shell mushroom
heart during the pumping phase; and
FIGS. 3A, 3B, 3C, and 3D are cross-sectional schematic views of one
modification of the soft shell mushroom heart during different
stages of the pumping cycle.
Referring to FIG. 1, the artificial heart as shown in schematic
comprises a blood pumping chamber 10 enclosed within a flexible,
and (to a limited extent) elastic, external wall 11 which is
restrained from distending beyond certain limits by a nonelastic,
flexible net 12. Pumping member 13 is periodically inflated by a
working fluid, which in the presently preferred embodiment is air.
A valve head 14 is formed as an integral part of pumping member 13.
As indicated by dashed arrows in the drawings, blood enters the
pumping chamber 10 through an opening between a valve seat 15 and
valve head 14. As indicated by the collapsed state of the external
wall 11, the volume of pumping chamber 10 is responsive to the
atrial filling pressure in response to Starling's Law. Flexibility
of external wall 11 of pumping chamber 10 allows blood to flow into
the pumping chamber 10 of the heart from the atrial filling chamber
without undue negative pressure being exerted upon the blood when
the working fluid or air is withdrawn from pumping member 13.
A valve 16 prevents the reverse flow of blood from the arterial
system during the filling phase of the artificial heart.
Referring to FIG. 2, the artificial heart is shown in schematic
during the pumping stage in which air is forced into pumping member
13 and simultaneously forces valve head 14 against valve seat 15.
The inlet to the pumping chamber is thus closed and the back flow
of blood through the inlet is prevented. Blood is pumped out of
pumping chamber 10 through valve 16 as shown by solid arrows in the
diagram. The flexible net 12 lies closely adjacent the external
wall 11 and prevents the further distention of the latter beyond
certain limits when the pumping member 13 is inflated. Even when
the atrial filling pressure is insufficient to completely fill the
pumping chamber 10, the pumping member 13 is still inflated to its
full extent and forces external wall 11 against net 12. The only
change resulting from a partial filling of the pumping chamber 10
is a reduction in the output volume of the artificial heart.
As illustrated in the drawing, valve head 14 and pumping member 13
are inflated simultaneously. However, this could result in a
reverse flow of some of the blood from the pumping chamber 10 at
the onset of inflation of pumping member 13. Therefore it is
suggested that that material comprising the elastic portions of
valve head 14 be constructed of a material which stretches under
less pressure than the material comprising the pumping member 13.
In this manner, the more elastic material of valve 14 would
preferentially distend to cause valve head 14 to occlude the blood
inlet before pumping member 13 starts to distend.
Referring to FIGS. 3A-3D, another embodiment of an artificial heart
is shown in four stages of pumping. The stages of filled pumping
chamber, closed inlet valve, inflated pumping member, and deflated
pumping member and valve are shown in FIGS. 3A, 3B, 3C, and 3D,
respectively.
Referring to FIG. 3A, the elastic material of valve head 14 is
shown in a relaxed state and enveloping a support member 17. Blood
is free to flow under normal atrial filling pressure between valve
head 14 and valve seat 15 into pumping chamber 10. The support
member 17 is in turn supported by an inflation conduit 18 that
passes interiorily through the pumping member 13. The inflation
medium for valve head 14 passes through inflation conduit 18 and
into the confines of valve 14 through passageways or holes 19 in
the support member 17. In this particular embodiment there is no
communication of the valve inflation medium with the interior of
pumping member 13.
The inflation control system for the valve head 14 operates
separately from the inflation control system for pumping member 13.
However, it is envisioned that the same inflation medium for valve
head 14 could also be used to inflate pumping member 13 after a
suitable delay in passage from valve head 14 into pumping member
13. The delay in passage of the inflation medium would create the
necessary sequencing between inlet valve closure and pumping member
13 inflation for optimal pumping efficiency. In either manner, it
is possible to achieve the sequential inflation of the valve and
pumping member for the optimal pumping efficiency of the artificial
heart.
Referring to FIG. 3B, the valve head 14 is shown in its fully
inflated state wherein it contacts the valve seat 15 to occlude the
blood inlet into the pumping chamber.
Base 21 serves as an attachment point between inflation member 13
and external wall 11 and as a means for segregating the inflation
medium of valve head 14 and pumping member 13 from the area
immediately surrounding the artificial heart. Inflation medium for
pumping member 13 passes through conduit 20 which serves both as an
inflation port and as a deflation port through base 21. Upon
deflation, the inflation medium is either returned to a control
device (not shown) located either interiorly or exteriorily of the
body, or in the case of air, allowed to escape to the
atmosphere.
Referring to FIG. 3C, pumping member 13 is shown in its fully
inflated state wherein it almost completely fills pumping chamber
10 and thus expels almost all the blood from pumping chamber 10
through valve 16.
Referring to FIG. 3D, both valve head 14 and pumping member 13 are
depicted in their deflated states to allow for the filling of
pumping chamber 10. External wall 11 is drawn inwardly by the
negative pressure created by the deflation of pumping member 13.
Blood enters pumping chamber 10 under the force of the atrial
filling pressure through the opening between valve head 14 and
valve seat 15. The quantity of blood in pumping chamber 10 will
thus depend upon the atrial filling pressure of the blood and in
this manner make the artificial heart of this invention highly
responsive to Starling's Law.
Valve 16 in all drawings may be any one of a number of appropriate
valves used in blood flow systems.
Although only one pumping chamber has been depicted in the drawings
and accompanying description, a complete artificial heart would
comprise two such chambers which would serve to completely replace
and duplicate the functions of the natural heart.
A single pumping chamber may be used in heart bypass operations to
replace or assist the pumping function of a ventrical of the
natural heart for any period of time required for healing of the
diseased natural heart.
All materials of construction in contact with blood and living
tissue are compatible with and noninjurious to the blood and living
tissue.
* * * * *