U.S. patent number 3,827,426 [Application Number 05/163,372] was granted by the patent office on 1974-08-06 for prosthetic pump.
Invention is credited to Mark Page, Philip N. Sawyer.
United States Patent |
3,827,426 |
Page , et al. |
August 6, 1974 |
PROSTHETIC PUMP
Abstract
A pump particularly suited for use as a prosthetic device in a
biological system to replace a pumping component of said system; a
novel electro-mechanical transducer; a method for providing a
prosthetic pump in a biological system; and method for forming an
electrically actuated contractile element for use on a pump. The
pump is formed of a resilient sidewalled chamber with exterior and
interior surfaces contoured in the shape of the component to be
replaced. The walls of the chamber are provided with one or more
contractile elements arranged so that upon contraction of said
elements the chamber will be contracted. A preferred contractile
element is formed of a titanium-nickel alloy such as Nitinol
selected from the class of binary equiatomic compounds of
transition elements from group IV and group VIII. By arranging the
Nitinol secured in a stressed orientation with respect to the
chamber wall, subsequent application of current pulses to the wire
will produce a heating of the Nitinol wire returning the wire to
its original unstressed shape, thereby contracting the the chamber
wall to produce pumping. The pump has particular application as an
artificial heart.
Inventors: |
Page; Mark (Brooklyn, NY),
Sawyer; Philip N. (Brooklyn, NY) |
Family
ID: |
22589757 |
Appl.
No.: |
05/163,372 |
Filed: |
July 16, 1971 |
Current U.S.
Class: |
623/3.11; 600/16;
417/413.1 |
Current CPC
Class: |
A61M
60/40 (20210101); F04B 17/00 (20130101); F04B
43/08 (20130101); A61M 60/122 (20210101); A61M
60/268 (20210101); F05C 2251/08 (20130101) |
Current International
Class: |
A61M
1/10 (20060101); F04B 43/00 (20060101); F04B
17/00 (20060101); F04B 43/08 (20060101); A61b
019/00 (); A61f 001/24 () |
Field of
Search: |
;128/1R,1D ;3/1,DIG.2
;417/413 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
Kolff - Scientific American, November, 1965, Vol. 213, No. 5 - pp.
38-46. .
Loehr et al. - Trans. Amer. Soc. Artif. Int. Orgs. Vol. X, 1964,
pp. 147-150..
|
Primary Examiner: Truluck; Dalton L.
Attorney, Agent or Firm: Fiddler; Robert W.
Claims
What is claimed is:
1. A pump chamber comprising a flexible wall contoured to enclose
and define a fluid containing space, said space forming a confined
volume chamber having inlet and outlet openings therein through
which fluid may flow to and from said confined volume; an elongate
contractile element secured at two spaced points to the wall
defining said confined volume externally of said confined volume,
said contractile element comprising an elongate member formed of an
alloy of binary equiatomic compounds of transition elements
selected from group IV of the periodic table of elements and group
VIII; and means periodically actuating said contractile element to
bring the points of said chamber wall between which said
contractile element is secured towards each other whereby the
volume confined by said wall is reduced to discharge fluid
contained in said chamber.
2. A pump chamber as in claim 1 in which said flexible walled
chamber is a molded plastic material.
3. A pump chamber as in claim 2 in which said chamber is formed of
ethylenevinylacetate.
4. A pump chamber as in claim 1 in which said contractile element
comprises Nitinol.
5. A pump chamber as in claim 4 in which said element is
sinusoidally shaped and annealed at a temperature of between
700.degree. and 1,400.degree. F., with the sinusoidally shaped
element stretched at a temperature below the annealing temperature
and secured in this stretched condition to said flexible walled
chamber in distended condition.
6. A pump chamber as in claim 5 in which said element is formed of
Nitinol having a Temperature Transition Range between 90.degree.
and 120.degree. F.
7. A pump chamber as in claim 5 in which said chamber is of a shape
simulating a human organ and is formed of a non-thrombogenic
material.
8. A pump chamber as in claim 7 in which said contractile element
comprises a Nitinol wire having a Temperature Transition Range
between 90.degree. and 120.degree. F. having a sinusoidal shape and
annealed at a temperature of over 700.degree. F. and secured with
respect to the chamber wall in a stretched orientation at a
temperature below 700.degree. F. to separate the undulations of the
annealed sinusoidally shaped Nitinol wire.
9. A pump chamber as in claim 7 in which said contractile element
comprises in addition to said annealed sinusoidally shaped Nitinol
wire, a strip of Nitinol annealed at a temperature above
700.degree. F. and secured with respect to the chamber wall in a
stretched orientation at a temperature below 700.degree. F.
10. A method for utilizing the pump chamber as formed in claim 7
comprising the steps of surgically removing the pumping organ from
the mammalian body which is to have the pumping organ replaced;
connecting the chamber to the fluid conducting ducts to which the
removed organ had been connected positioning the pump chamber in
place of the removed organ; and connecting the ends of the Nitinol
material secured to the chamber to a source of electrical energy
providing pulses of electrical energy timed to simulate the pumping
pulses of the replaced organ.
11. A method as in claim 10 in which the Nitinol material is
provided in a plurality of spaced arrays on the pump chamber; and
said arrays are electrically energized in a timed sequence to
contract different portions of the pump chamber sequentially.
Description
BACKGROUND OF INVENTION
This invention relates to the art of prosthetic devices, and more
particularly to a pump and means for actuating the pump so that the
pump becomes particularly suited for use in replacing a natural
pumping component of a biological system, such as a mammalian
heart.
A variety of attempts have been made to evolve an artificial
pumping member suitable for implantation in a living body to
replace a diseased or otherwise deteriorated pumping component of
the body. Thus a variety of artificial hearts have been evolved
intended for use in replacing a mammalian heart.
Such previously developed artificial hearts have in the past
employed diaphragm actuated or reciprocating mechanical pumps or
have utilized hydraulic or pneumatically powered balloons to eject
the contents of substantially cylindrical rigid walled chambers in
which the balloon was positioned. These pumping members are often
employed to produce desired pumping action in a flexible walled
member inserted to replace the natural heart, with the flexible
walled member acting as a reservoir. However, the natural heart is
itself a pump with the sidewalls of the heart chambers contracting
and expanding to effect desired blood pumping through the
circulatory system. Thus the previously evolved artificial heart
systems employing a pump in addition to the replaced prosthetic
heart chambers are difficult of emplacement since they require an
additional pumping member difficult of insertion into the available
thoracic cavity space in which the natural heart being replaced was
positioned.
The mammalian heart has a number of characteristics which are
unique and have in the past been difficult of replication by an
artificial device. Some of these characteristics are:
1. Relatively low pressure contractile atrial collecting and
pressure sensitive reservoirs;
2. Surfaces which are not smooth, but contain contracting
trabeculae, to prevent dead space stasis of blood at the
blood-heart interface and thus prevent mural thrombus
formation;
3. Chamber contents ejection capability built into the muscle walls
of the chambers themselves;
4. A contractile neurological timing system including the SA and AV
node and Purkinje fiber system to insure satisfactory rhymicity of
the multi-chambered heart with timed interdigitated contractions of
the multiple chambers of the heart;
5. Built in volume pressure, and flow sensors in the heart and,
inflow and outflow veins and arteries which prevent overdistention
of the myofibrilae and abnormal chamber pressures;
6. Valving at least partially active with good hydraulic
configuration to insure (a) minimal leakage; (b) minimal resistance
to flow; (c) minimal turbulence; and (d) long term function.
In attempting to attain the above recited characteristics in a
prosthetic pump, it is desirable to provide some means for
contracting the chamber simulating the natural pumping member,
which can be incorporated in the chamber walls.
SUMMARY OF INVENTION
It is with the above desiderata in mind that the present pump,
means for actuating same, and method for employing the pump as a
prosthetic pump such as an artificial heart in a biological system
such as a mammalian body has been evolved. The pump provides the
two fold function of storing and pumping the fluid such as blood in
the same fashion as performed by the natural heart or other natural
pumping component to be replaced, and may be formed to the
identical configuration of the replaced natural organ to perform
the identical functions.
It is accordingly among the primary objects of the invention to
provide an improved prosthetic pump capable of simulating and
replacing a natural pump such as a heart in a mammalian body.
Another object of the invention is to provide a prosthetic pump
subject to being formed with identical interior and exterior
surface contours of a natural pumping organ such as a mammalian
heart.
A further object of the invention is to provide a prosthetic pump
having a flexible walled fluid receiving chamber, in which the
chamber confines may be contracted to effect pumping in the same
fashion as occurs in a natural pump such as a heart.
It is also an object of the invention to provide an artificial
heart which does not require any auxiliary pumping apparatus other
than that provided by the artificial heart.
A further object is to provide a method of replacing a natural
heart with a prosthetic pump.
It is also an object of the invention to provide an improved
electro-mechanical transducer.
These and other objects of the invention which will become
hereafter apparent are achieved by forming a pump of a resilient
biologically inert material shaped to form a chamber with the
exterior and interior surfaces of the chamber preferably contoured
to duplicate the exterior and interior surfaces of the natural
pumping component such as a mammalian heart to be replaced in the
biological system. Contractile elements are arranged with respect
to the chamber walls so that upon contraction of the contractile
elements the chamber will be contracted to provide desired pumping.
The contractile elements according to the hereinafter described
preferred embodiment of the invention are formed of a
titanium-nickel alloy such as 55 Nitinol bent to form one or more
return bends, a sinusoidally shaped configuration being preferred.
The undulations of the sinusoidally shaped Nitinol wire are
displaced from their normal configuration, preferably by stretching
to spread the legs between the return bends of the sinusoidally
shaped wire from their normal shape and the wire is secured with
respect to the chamber walls. Thereafter upon passage of a current
through the Nitinol wire, the increase in temperature of the wire
causes the stretched sinusoidally shaped wire to return to its
initial condition of shaping, contracting the chamber sidewalls and
the chamber volume to produce a pumping action.
A feature of the invention resides in the arrangement of the
contractile elements with respect to the chamber walls so as to
provide a replica of typical twisting, wringing heart contracting
action.
Another feature of the invention resides in the dimensioning of the
heat actuated contractile elements of a cross-sectional size such
that heat energy is converted to mechanical energy of restoration
of the sinusoidal wire, without excessively raising the temperature
of any surrounding tissue in which the prosthetic pump is
implanted, to a level which is detrimental to the function of the
tissue.
BRIEF DESCRIPTION OF DRAWINGS
The specific details of a preferred embodiment of the invention and
their mode of functioning will be particularly pointed out in full,
clear, concise and exact terms in conjunction with the accompanying
drawings wherein:
FIG. 1 is a perspective diagramatic view of a prosthetic pump
simulating a heart chamber made in accordance with the teachings of
the invention showing the contractile elements formed by a
plurality of sinusoidally shaped Nitinol wires arranged to
helically encircle a heart ventricle simulating pump;
FIG. 2 is a perspective view of another embodiment of a prosthetic
pump simulating a heart ventricle showing an arrangement of
contractile elements providing multiple helical bands surrounding
the pump chamber at two levels along with multiple hemi-elipsoid
strands extending longitudinally about the chamber;
FIG. 3 is a perspective view of another embodiment of another
prosthetic pump simulating a heart ventricle showing an arrangement
of bands of Nitinol helically surrounding two spaced transverse
levels of the ventricle, with longitudinally extending contractile
elements to provide for both the exertion of lateral and
longitudinal forces on the pump chamber;
FIG. 4 is a perspective view of a ventricle simulating pump
illustrating an arrangement utilizing a plurality of spaced Nitinol
bands arranged to helically surround the pump chamber;
FIG. 5 is a schematic cross sectional elevational view through a
chamber wall showing a sinusoidally arranged Nitinol wire
positioned to lie in a plane perpendicular to the chamber wall;
FIG. 6 is an end view of the proposed arrangement shown in FIG.
5;
FIG. 7 is a cross sectional view through a chamber wall showing the
sinusoidally shaped Nitinol wire positioned to lie in a plane
tangent to the chamber; and
FIG. 8 is a top plan view of the arrangement shown in FIG. 7.
DESCRIPTION OF PREFERRED EMBODIMENTS OF THE INVENTION
Referring now more particularly to the drawings, like numerals in
the various Figures will be employed to designate like parts.
As illustratively shown in FIG. 1, the inventive concept is shown
as embodied in the formation of a prosthetic pump suitable for use
in forming an artificial heart. As seen in FIG. 1, a pump chamber
10 is formed to simulate the interior and exterior contours of a
mammalian heart ventricle. In forming the pump chamber 10 so as to
permit its use in replacing a heart ventricle, a mold is first made
of a natural mammalian heart ventricle simulating the contours of
the natural heart ventricle. The chamber 10 is then formed in this
mold utilizing a molding apparatus of the type shown by Page U.S.
Pat. No. 3,881,476, charging the mold with a non-thrombogenic
material. Ethylenevinyl-acetate (EVA) is found to provide desired
antithrombogenic properties. The addition of additives such as
Dextran "40" to the ethylenevinylacetate (EVA) is found to further
improve the anti-thrombogenic properties. The chamber has
additionally been formed of silicone rubber. As will be understood
by those skilled in the art, a variety of flexible antithrombogenic
materials may be molded to form the resilient walled chamber 10.
Polymers such as Silastic, polyurethane, block polyurethane or the
like may be employed.
As schematically illustrated in FIG. 1, a contractile element 15 is
shown as helically wound to extend from a top terminal point 16
adjacent the upper left end of the illustrated pump chamber 10
around the walls of the chamber down to a lower terminal point
17.
The contractile element 15 in the illustrated embodiment is formed
of a Nitinol wire bent into a sinusoidal shape. Nitinol is an alloy
of titanium and nickel. A 55 Nitinol, that is an alloy containing
55 percent nickel by weight, with the balance titanium with or
without the addition of cobalt is found satisfactory. However, a
variety of other percentages of nickel in the Nitinol alloy may be
employed. It is further contemplated within the scope of this
invention that a number of alloys formed of binary equiatomic
compounds of transition elements from group IV (Ti, Zr or Hf) and
group VIII (Ni, Co, Fe or Ru and Rh, Pd; or Os, Ir, Pt) which have
a martensitic transition in a temperature range of between
50.degree. to 80.degree. F. may be suitable. If such compounds are
formed into a given shape and annealed at a given temperature (of
between 700.degree. and 1,400.degree. F.), subsequent plastic
deformation occurring at temperatures below the annealing
temperature will be removed upon heating of the material through
its Temperature Transition Range (TTR) which dependent on the alloy
composition may be formed to range between -150.degree. to
225.degree. F. returning the material to its original annealed
shape. Messrs. F. E. Wang and W. J. Buehler of the U.S. Naval
Ordinance Laboratory have described this phenomena in the Journal
of Applied Physics 39:2166 1968.
In the embodiment of the invention illustrated in FIG. 2, the pump
chamber 10 is formed as described in connection with the FIG. 1
embodiment to simulate the contours of a mammalian heart ventricle,
with the chamber 10 being formed preferably of an antithrombogenic
material such as EVA, or the like. In this FIG. 2 embodiment of the
invention, the contractile elements are arranged so as to provide a
plurality of sinusoidally bent Nitinol wire helically wound about
an upper transverse level 18 of the chamber 10; and a second
plurality of sinusoidally bent Nitinol wire helically wound about a
second level 20 of the chamber 10. The sinusoidally bent Nitinol
wire shown in the illustrated embodiment is a 55 Nitinol wire which
has been bent into a sinusoidal configuration and annealed at a
temperature of approximately 700.degree. C. In positioning the
sinusoidally bent wire on the chamber wall 10 the undulations of
the annealed sinusoidally shaped wire are spread so as to
elastically deform same. In addition to the contractile elements
arranged at levels 18 and 20 a plurality of annealed sinusoidally
bent wire strands 22 and 24 are arranged to extend between terminal
points 25 and 26 (at the top of the chamber 10) down around the
lower tip of the chamber to provide a double hemi-elipsoid girdling
of the chamber in a direction extending along the longitudinal axis
of the chamber 10.
In the embodiment of the invention illustrated in FIG. 3, a
suggested arrangement of contractile elements shown is provided by
an illustratively shown circumferentially extending upper
contractile band 31 formed of a strip of Nitinol annealed at
between 950.degree. and 1,100.degree. F. and elastically stretched
at room temperature of between 50.degree. and 100.degree. F. to
extend about the upper end of the illustratively shown chamber 10
between terminals 32 and 33. A second lower band 35 is shown
stretched between terminals 36 and 37 and circumferentially
surrounding a lower end of the chamber 10. In order to provide
contraction of the chamber 10 in a longitudinal direction, as
illustrated a sinusoidally shaped annealed Nitinol wire is
helically wound as shown to extend from top to bottom of the
chamber 10 in a substantially helical wrap around arrangement. The
wire is preferably separated into two or more segments 38 and 39,
each providing a separate circuit for a reason to be hereinafter
described.
In the FIG. 4 embodiment of the invention, the chamber 10 is shown
as provided with a plurality of spaced straps 41 of Nitinol
annealed at a temperature between 950.degree. and 1,400.degree. F.
which are arranged to helically surround the chamber 10. Electrical
terminals 42 are provided between each of the straps 41 for
electrical connection to the straps. The straps 41 are elastically
stretched at room temperature between 50.degree. and 90.degree. F.
before securing them to the chamber wall.
Some suggested arrangements for positioning of the sinusoidally
shaped contractile elements are illustrated in FIGS. 5-8. The
sinusoidal contouring of the Nitinol may be accomplished in a
variety of fashions. Thus Nitinol wire may be bent on a jig to
provide desired sinusoidal contour; or a plate of Nitinol may be
punched or etched into the desired sinusoidal shape. The Nitinol
which has been either bent etched, machined or otherwise formed
into deisred shape at normal room temperatures of between
50.degree. and 100.degree. F. is then annealed at a temperature of
between 700.degree. and 1,500.degree. F.
In the FIG. 5 illustration, a section of a pump chamber 10 is shown
in cross section, with the sinusoidally contoured annealed Nitinol
secured to the surface of the chamber 10 with the sinusoidally
contoured Nitinol stretched to separate the undulations and
arranged in a plane perpendicular to the chamber surface, as shown
in FIG. 6.
Alternatively, as shown in FIGS. 7 and 8, a plurality of annealed
sinusoidally contoured Nitinol elements may be stretched and
secured to the chamber surface in a plane tangent thereto.
It will be understood by those skilled in the art that though the
contractile elements have been shown as applied to the chamber wall
on the surface thereof, these contractile elements may readily be
incorporated into the chamber wall.
OPERATION
Four suggested arrangements of contractile elements on a prosthetic
pump chamber contoured to simulate a mammalian heart ventricle have
been illustrated and described. It will of course be understood by
those skilled in the art that the illustrated and described
arrangements may readily be varied within the scope of this
invention.
In use, the contractile elements are energized to produce a
contractile force on the pump chamber 10 to provide desired pumping
action.
The thermo-mechanical transducer properties of Nitinol have been
recognized. Though the exact mechanism permitting this
thermo-mechanical transduction has not been fully explained,
Buehler and Wang have suggested a model having a crystalline
structure with two states closely related in terms of energy and
interatomic distances. In this model, all atoms in the same plane
of dislocation move cooperatively when the crystal is deformed by
shear stress. Thus, some atoms in adjacent layers approach each
other. With increasing temperature the relatively lighter titanium
atoms will tend to vibrate at a larger amplitude around their
equilibrium position and exert a repulsive diagonal force which
contributes to the recovery of the crystal to its initial
crystalline structure which has been formed by annealing. The
necessary heat to produce the crystalline transformation required
to restore a deformed Nitinol element to its original annealed
shape may be obtained due to the electrical resistivity of the
Nitinol element, as a result of which the passage of an electrical
current through the Nitinol appears to produce sufficient heat in
the Temperature Transition Range to provide desired crystalline
transformation. As a result, electro-mechanical transducing may be
obtained.
By connecting the Nitinol contractile elements shown in the various
illustrated and described embodiments, and energizing these
elements selectively, desired pumping to simulate the pumping
action of a natural element to be replaced by the prosthetic pump
is obtained. Thus, in order to simulate a heart, the contractile
modules are arranged to simulate the muscle fibers in the heart.
These contractile elements are arrayed with respect to the walls of
the chamber by either molding in place, or post-molding
emplacement. They are arrayed in a multiple helical pattern and are
activated and timed sequentially to contract and thereby helically
wring the pump chamber 10 from apex to base as in the mammalian
heart, as takes place in the normal ventricular contractile process
during the systolic phase of the heart beat. Upon termination of
flow of the electrical current through the contractile element, the
contractile element which is anchored at spaced points to the
elastic walled chamber will be stretched by the return of the
chamber wall to its initial diastolic orientation.
In forming the prosthetic pump as illustrated schematically in FIG.
1, a length of 50 Nitinol wire having a Temperature Transition
Range (TTR) of between 90.degree. and 120.degree. F. is wound into
a sinusoidal configuration with a wave length between undulations
of approximately three-fourths of an inch, and an amplitude of
approximately three-eighths of an inch. This sinusoidally oriented
50 Nitinol wire is then baked in an oven to anneal same at a
temperature of between 700.degree. and 1,400.degree. F. The
annealed sinusoidally oriented wire is then permitted to cool
gradually to room temperature. The annealed wire is then stretched
and secured to the chamber 10, in the orientation illustrated in
FIG. 1 to extend helically around the chamber between terminals 16
and 17. In positioning the contractile element 15 on the chamber
10, the undulations of the wire are separated to provide a wave
length of approximately 7/8 inches between undulations. Subsequent
heating of the stretched sinusoidally shaped wire to the TTR (which
is selected to lie between 105.degree. and 130.degree. F.) will
result in return of the Nitinol wire to its original annealed
orientation. The application of the desired temperature may be
obtained by connecting terminals 16 and 17 in an electrical circuit
preferably including a trigger circuit 100 which may take the form
of a Schmidt trigger or any one of a wide variety of conventionally
available pulse forming circuits to an electrical current source
110. Upon discontinuance of current flow, in order to effect the
desired crystalline transformation according to the Buehler model
of titanium, it is required that a given quantity of heat be added
to the wire.
In selecting the gauge of Nitinol, and current to be applied so as
to produce the necessary crystalline change, the wire is preferably
selected of a dimension such that the electrical resistance will
produce the required heat which is substantially dissipated in
crystalline transformation so that there is no excessive
temperature increase in the surrounding ambience of the wire, as a
result of which implantation of the prosthetic pump in living
tissue will not interfere with desired tissue function. A 55
Nitinol wire gauge of 0.020 inch, with a length of 2 inches between
terminals connected across a 45 volt source is found to produce
eminently satisfactory results. Nitinol wires containing between 45
and 60 percent weight having a gauge between 0.015 inch and 0.090
inch with a TTR of between 100.degree. F. and 130.degree. F. have
been employed.
The operation of the various illustrated embodiments will of course
be apparent to those skilled in the art, it being understood that
the different contractile modules are selected of a length and
thickness permitting their positioning as illustrated with respect
to the pump chamber wall. Electrical connections are made to the
terminals of each wire or strap array and the circuit energized to
provide desired pulses to provide desired frequency of pumping, it
being understood that an electrical pulse will be provided in
desired sequence and of desired duration to heat the array to a
temperature in its TTR causing the array to contract to its
original annealed position.
* * * * *