U.S. patent number 3,884,243 [Application Number 05/370,215] was granted by the patent office on 1975-05-20 for implantable heart pacer or the like with internal cell electrode.
This patent grant is currently assigned to Corsan Engineering, Inc.. Invention is credited to Jozef Cywinski.
United States Patent |
3,884,243 |
Cywinski |
May 20, 1975 |
Implantable heart pacer or the like with internal cell
electrode
Abstract
An implantable heart pacer comprising electrode means of
dissimilar materials spaced from one another to provide an
electrolyte-containing space therebetween for cooperating with an
electrolyte therein to produce a cell voltage, being in
communication with the exterior of said device. One of the
electrode means has its surface exposed only to the
electrolyte-containing space and is free from exposure on an
external surface of said device to prevent direct contact with body
tissues. A sealed electronic pulse unit provides an output pulse of
higher voltage than said cell voltage, said electrode means
providing a power source for said unit and providing an indifferent
electrode for return current flow from a remote unipolar heart
electrode connected to the output pulse terminal. With an output
pulse voltage greater than the cell voltage, there is reverse
current flow in the electrode means during the pulse for
electrolytically cleaning their surfaces.
Inventors: |
Cywinski; Jozef (Duxbury,
MA) |
Assignee: |
Corsan Engineering, Inc.
(Duxbury, MA)
|
Family
ID: |
23458725 |
Appl.
No.: |
05/370,215 |
Filed: |
June 15, 1973 |
Current U.S.
Class: |
607/35; 429/498;
429/432; 429/523; 307/110 |
Current CPC
Class: |
A61N
1/378 (20130101) |
Current International
Class: |
A61N
1/372 (20060101); A61N 1/378 (20060101); A61n
001/36 () |
Field of
Search: |
;128/419B,419C,419E,419P,419R,421-423,2P,2C ;307/110
;136/184,86A,86F |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
Drake et al., "Transactions of the American Society for Artificial
Internal Organs" Vol. XVI, 1970, pp. 199-205..
|
Primary Examiner: Kamm; William C.
Claims
What is claimed is:
1. For use in combination with a single remote unipolar implantable
heart electrode, an implantable electronic pulse heart pacer device
comprising
at least two electrode means of dissimilar materials spaced from
one another to provide an electrolyte-containing space therebetween
for cooperating with electrolyte therein to produce a cell
voltage
insulation means mounting at least one of said electrode means so
that its surface is exposed only to said electrolyte-containing
space within the outer periphery thereof and is free from exposure
on an external surface of said device to prevent direct contact of
said one electrode with body tissues
said electrolyte-containing space being in communication with the
exterior of said device
a sealed electronic pulse unit electrically insulated from said
electrodes, said unit having input terminals connected to said
electrode means and a single output pulse terminal for connection
to said heart electrode
said electrode means providing a power source for said unit and
providing an indifferent electrode for return current flow from
said single remote implantable heart electrode connected to said
output pulse terminal.
2. For use in combination with a single remote unipolar implantable
heart electrode, an implantable electronic pulse heart pacer device
comprising
a plate cathode element of body tissue non-reactive material having
an outer peripheral edge
a plate anode element of reactive material having an outer
peripheral edge, said anode element being positioned ajdacent said
plate cathode element spaced from said cathode element to provide
an electrolyte-containing space therebetween for cooperating with
an electrolyte therein to produce a cell voltage
said electrolyte-containing space being in communication with the
exterior of said device
said plate cathode element forming a major external wall portion of
said device and
insulation means mounting said plate anode element so that its
surface is exposed only to said fluid electrolyte-containing space
and is free from exposure on an external surface of said device to
prevent direct contact of said reactive anode material with body
tissue
a sealed electronic pulse unit mounted within the outer peripheral
edges of said electrodes and electrically insulated therefrom,
said electronic pulse unit having input terminals connected to said
cathode and anode elements and a single output pulse terminal for
connection to said heart electrode, said unit having circuit means
providing at said output terminal an output pulse
said cathode and anode elements providing a power source for said
unit and providing an indifferent electrode for return current flow
from said single remote implantable heart electrode connected to
said output pulse terminal.
3. For use in combination with a single remote unipolar implantable
heart electrode, an implantable electronic pulse heart pacer device
comprising
a pair of spaced opposing plate cathode elements of body tissue
non-reactive material having outer peripheral edges
a generally "C" shaped plate anode element of reactive material
having an outer peripheral edge, said anode element being
positioned between and spaced from said cathode elements to provide
a fluid electrolyte-containing space therebetween for cooperating
with an electrolyte therein to provide a cell voltage
electrical insulation means extending between the outer peripheral
edges of said elements defining the outer periphery of said
electrolyte-containing space
said electrolyte containing space being in communication with the
exterior of said device
said plate cathode elements forming a major external wall portion
of said device and
insulation means mounting said plate anode element so that its
surfaces are exposed only to said electrolyte-containing space and
is free from exposure on an external surface of said device to
prevent direct contact of said reactive anode material with body
tissue
a sealed electronic pulse unit mounted within the outer peripheral
edges of said electrodes and electrically insulated therefrom, said
C-shaped plate anode element surrounding a major portion of said
pulse unit
said electronic pulse unit having input terminals connected to said
cathode and anode elements and a single output pulse terminal for
connection to said heart electrode, said unit having circuit means
providing at said output pulse terminal an output pulse having a
voltage greater than that of said cell voltage
said cathode and anode elements providing a power source for said
unit and providing an indifferent electrode for return current flow
from said single remote implantable heart electrode connected to
said output pulse terminal
said output pulse voltage when greater than said cell voltage
causing reverse current flow in said cathode and anode elements for
a substantial portion of an output pulse for cleaning said
electrodes.
4. An implantable electronic pulse heart pacer device as claimed in
claim 3, wherein
said electronic pulse unit circuit means includes a pulse source
and a pulse voltage multiplying circuit comprising
a plurality of capacitors connected to provide preceding and
succeeding capacitors, each connected through resistor means to
said electrodes
a plurality of switching transistors having their bases connected
to said pulse source, their emitters connected to one terminal of a
preceding capacitor and their collectors connected to the other
terminal of a succeeding capacitor, said transistor switching means
being responsive to an input pulse for simultaneously switching
said capacitors from parallel to series connection with each other
for the duration of said input pulse
said capacitors when connected to each other in parallel connection
being connected across said electrode means to charge said
capacitors and when connected to each other in series connection
being connected to said output pulse terminal to discharge said
capacitors to provide said output pulse voltage greater than said
cell voltage.
5. For use in combination with a single remote unipolar implantable
heart electrode, an implantable electronic pulse heart pacer device
comprising
a plate cathode element of body tissue non-reactive material having
an outer peripheral edge
a plate anode element of reactive material having an outer
peripheral edge, said anode element being positioned adjacent said
plate cathode element spaced from said cathode element to provide
an electrolyte-containing space therebetween for cooperating with
an electrolyte therein to produce a cell voltage
said electrolyte-containing space being in communication with the
exterior of said device
said plate cathode element forming a major external wall portion of
said device and
insulation means mounting said plate anode element so that its
surface is exposed only to said fluid electrolyte-containing space
and is free from exposure on an external surface of said device to
prevent direct contact of said reactive anode material with body
tissue
an electronic pulse unit having input terminals connected to said
cathode and anode elements and a single output pulse terminal for
connection to said heart electrode, said unit having circuit means
providing at said output terminal an output pulse
said cathode and anode elements providing a power source for said
unit and providing an indifferent electrode for return current flow
from said single remote implantable heart electrode connected to
said output pulse terminal.
6. For use in combination with a single remote unipolar implantable
heart electrode, an implantable electronic pulse heart pacer device
comprising
a plate cathode element of body tissue non-reactive material having
an outer peripheral edge
a plate anode element of reactive material having an outer
peripheral edge, said anode element being positioned adjacent said
plate cathode element spaced from said cathode element to provide
an electrolyte-containing space therebetween for cooperating with
an electrolyte therein to produce a cell voltage
said electrolyte-containing space being in communication with the
exterior of said device
said plate cathode element forming a major external wall portion of
said device and
insulation means mounting said plate anode element so that its
surface is exposed only to said fluid electrolyte-containing space
and is free from exposure on an external surface of said device to
prevent direct contact of said reactive anode material with body
tissue
a sealed electronic pulse unit mounted within the outer peripheral
edges of said electrodes and electrically insulated therefrom,
said electronic pulse unit having input terminals connected to said
cathode and anode elements and a single output pulse terminal for
connection to said heart electrode, said unit having circuit means
providing at said output terminal an output pulse having a voltage
greater than that of said cell voltage
said cathode and anode elements providing a power source for said
unit and providing an indifferent electrode for return current flow
from said single remote implantable heart electrode connected to
said output pulse terminal
said output pulse voltage when greater than said cell voltage
causing reverse current flow in said cathode and anode elements for
a substantial portion of an output pulse.
Description
This invention relates to implantable electronic pulse devices,
such as heart pacers and other stimulators, and, more particularly,
to such devices which have electrodes providing both a power source
and an indifferent electrode for return of stimulating current flow
through the body fluids.
Although heart pacers powered by electrodes using body fluids as an
electrolyte have been disclosed, for example in U.S. Pat. No.
3,421,512, they are deficient in a number of respects, which
heretofore has made impractical their use in humans as a
replacement for conventional battery powered heart pacers. There
are a number of reasons for their deficiencies. Among these are
problems caused by the reaction of the active metal electrode, the
difficulty of keeping the electrode surface active and clean enough
to function over long periods of time, and the difficulty of
providing in conjunction therewith an indifferent electrode for
return current flow through the body fluids from a remote electrode
connected to the heart pacer output.
Accordingly, it is an object of the present invention to solve the
above problems and provide a novel implantable electronic pulse
device, such as a heart pacer or the like, having a greatly
extended operating life as compared to conventional battery powered
devices.
This is accomplished, according to the present invention, by
providing a device having a number of unique features.
In one aspect of the invention, there is provided an implantable
electronic pulse device comprising at least two electrode means of
dissimilar materials spaced from one another to provide an
electrolyte-containing space therebetween for cooperating with an
electrolyte therein to produce a cell voltage, said
electrolyte-containing space being in communication with the
exterior of said device and at least one of said electrode means
having its surface exposed only to said electrolyte-containing
space and being free from exposure on an external surface of said
device to prevent direct contact of said one electrode with body
tissues.
In another aspect, the present invention provides an implantable
electronic pulse device comprising at least two electrode means of
dissimilar materials spaced from one another for cooperating with
an electrolyte to produce a cell voltage, and an electronic pulse
unit having input terminals connected to said electrode means and
an output pulse terminal, said electrodes providing a power source
for said unit and providing an indifferent electrode for return
current flow from a remote electrode connected to said output pulse
terminal. Preferably, said output pulse voltage is higher than said
cell voltage, causing reverse current flow in said electrode means
for a substantial portion of an output pulse for cleaning said
electrodes.
Still other aspects of the present invention include the provision
of a sealed electronic pulse unit mounted within the peripheries of
the electrodes and electrically insulated therefrom and a pulse
voltage multiplying circuit for raising the relatively low cell
voltage to a value sufficiently high to provide a heart pacing
function.
For the purpose of explaining the above and still further objects,
features and aspects of the present invention, reference is now
made to the following detailed description of a preferred
embodiment thereof, together with the accompanying drawings
wherein:
FIG. 1 is a diagrammatic view of the device of the invention
implanted for heart stimulation;
FIG. 2 is a side view, partly in section, of the device of FIG.
1;
FIG. 3 is an end view, partly in section, of the device of FIG.
1;
FIG. 4 is an exploded view of the device of FIG. 1, showing the
major elements thereof; and
FIG. 5 is a circuit diagram of the electronic pulse unit of the
device of FIG. 1.
Referring to the drawings, in IFG. 1 is shown a heart pacer device,
generally designated 10, implanted in a body and having a single
remote output pulse, so-called unipolar, heart stimulating
electrode suitably attached to a heart 14 to stimulate it, the
return current flow, shown as dashed line 16, to the indifferent
electrode of pacer device 10, being through the body fluids 18
which also function as an electrolyte for power generation.
According to the present invention, the implantable electronic
pulse heart pacer 10 thereof has electrodes of dissimilar materials
spaced from one another for cooperating with an electrolyte to
produce a predetermined cell voltage for powering device 10 to
produce suitable heart stimulating output pulses, as well as
providing the indifferent electrode thereof.
More specifically, as best shown in FIGS. 2 through 4, there is
provided a pair of spaced, opposing, plate cathode elements 22, 24,
of disk shape. Such elements are of body tissue non-reactive and
electrolytically non-consumable material, preferably of a platinum
black activated carbon material, and form a major external wall
portion of device 10. These elements are preferably of a two layer
fuel cell platinum catalyst electrode, manufactured by E.S.B.,
Inc., of Yardley, Pa. Such electrode consists of an apertured
tantalum outer plate 26, carrying the platinum black activated
carbon, and a porous teflon inner plate 28, the entire electrode
being porous for ionic communication therethrough.
Positioned between cathode elements 22, 24 is a plate anode element
23 of reactive electrolytically consumable material, preferably
zinc or aluminum, for example. Plate anode element 23 is generally
C-shaped, with an outer periphery generally of about the same
diameter as that of cathode elements 22, 24 and with a rectangular
cutout 29 on one side thereof. Anode element 23 is generally
parallel to and spaced from said cathode elements to provide an
electrolyte-containing space therebetween.
During the electrochemical reaction to generate electrical energy
in the cell including the cathode and anode elements 22, 23 and 24
and the electrolyte-containing space therebetween, anode element 23
is gradually dissolved in the electrolyte and is converted into
metal ions, metal hydroxide ions and metal oxide ions. To this end,
however, it is essential that the electrolyte in the
electrolyte-containing space be in communication with the body
fluids to provide a source of oxygen to the cell. Although it is
preferred that this be accomplished by free body fluid
communication with the interior of the cell by utilizing the body
fluids as the electrolyte, it may also be accomplished by ionic or
even gaseous communication to permit diffusion of oxygen, without
direct communication by body fluids. Under these circumstances, the
anode mass loss due to Faraday current and spontaneous metal decay
(corrosion) are the only factors which limit the effective life of
the power generating cell of the invention, and the anode mass can
readily be made large enough to last for upwards of ten years.
A generally cylindrical electrical insulation element 30 extends
between the outer peripheries of the electrode elements 22, 23, 24,
defining the outer periphery of the electrolyte-containing space on
both sides of anode element 23, said electrolyte-containing space
being in communication with the exterior of device 10, both through
the porous cathode elements 22, 24 and through optional apertures
32 in insulation element 30.
It is a particular feature of the invention that the reactive plate
anode element 23, since it has its surfaces exposed only to the
electrolyte-containing space within the outer periphery of
insulation element 30, is completely free from exposure on an
external surface of device 10 to prevent direct contact of the body
tissue reactive anode material with body tissue when the device is
implanted. Nevertheless, as explained above, anode element 23 is in
direct communication with body fluids so that it is able to
function in conjunction with cathode elements 22, 24 to provide a
large indifferent electrode surface area of about four times the
exposed surface area of device 10.
A sealed electronic pulse unit 40 is mounted within the peripheries
of the electrode elements 22, 23, 24 and is electrically insulated
therefrom and from body fluids by an insulating cover 42, the
C-shaped plate anode element 23 surrounding a major portion of said
pulse unit which fits within its rectangular cutout 29. The exposed
insulated end of electronic pulse unit 40 has input terminals 44,
46, 48 connected, respectively, to cathode and anode elements 22,
24 and 23 and an output pulse terminal 50, said unit providing at
said output terminal an output voltage pulse. An external electrode
12 remote from device 10 may be connected to output terminal 50 in
the usual manner for providing heart stimulation.
The electrical circuitry of pulse unit 40 is shown in FIG. 5. In
general, it includes a pulse timing and generating circuit 52, a
pulse shaping circuit 54 and an output pulse voltage multiplying
circuit 56. Pulse generating circuit 52 and pulse shaping circuit
54 are well known; for example, similar circuits are shown in U.S.
Pat. No. 3,057,356 for generating pulses at a rate of 60-70 per
minute for heart simulation. However, since a relatively low cell
voltage of about one volt is produced by cathode and anode elements
22, 23, 24 and a higher voltage, preferably of about four to eight
volts, is needed for heart stimulation, a voltage multiplier
circuit is needed to produce the requisite output pulse
voltage.
Although this may be provided by a conventional pulse transformer,
it is preferred that the more efficient circuit 56 of FIG. 5 be
utilized.
Specifically, the pulse voltage multiplier output circuit of FIG. 5
consists of a plurality of capacitors 60 each connected to cathode
terminals 44, 46 through resistor 62 and to anode terminal 48
through resistor 64. A series of N-P-N switching transistors is
provided for simultaneously switching capacitors 60 from parallel
to series connection, each said transistor having its base 66
connected to the pulse output connection 70 of pulse forming
circuit 54 which provides a pulse source, its emitter 67 connected
to the preceding junction of capacitor 60 and resistor 62 (except
the first transistor in the series which has its emitter connected
to cathode terminals 44, 46) and its collector connected to the
succeeding junction of capacitors 60 and resistors 64 (except the
last transistor in the series which has its collector connected to
anode terminal 48 through resistor 72 and to pulse output terminal
50 through capacitor 74). Preferably, eight such capacitor and
transistor circuits are used to produce about an eight volt output
pulse from a one volt input pulse on connection 70. In ambient
condition, capacitors 60 are each charged through their resistors
62, 64, the transistors being non-conducting under such condition.
When a pulse is applied from line 70 to the bases 66 of the
transistors, they are switched to conducting condition, such being
effective to connect the capacitors 60 in series so that the
voltage charges thereon are added together and discharged through
output pulse terminal 50.
The output pulses so generated are then delivered through a
suitable connecting wire to the unipolar stimulating electrode 12
at the heart 14 or other internal organ. The stimulating current
flows in a circuit depicted in FIG. 1. This circuit consists of a
source of high current density stimulus, namely the unipolar
stimulating electrode 12, the organ under stimulation, herein the
heart 14, the electrically conductive body tissue and fluid 18, the
indifferent electrode system which is constituted of cathode
elements 22, 24 and anode 23 and, finally back to electronic pulse
unit 40.
The cathode and anode elements thus provide a power source for unit
10 and also provide an indifferent electrode for return current
flow through the body fluid electrolyte from remote output
electrode 12 connected to output pulse terminal 50. Since the
output pulse voltage is greater than the battery voltage, it causes
reverse current flow in the electrodes for a substantial portion of
an output pulse for electrolytic cleaning of the electrode
surfaces. This is an important aspect of the device of the
invention since it continuously cleans these surfaces to permit
them to function during the upwards of ten year period during which
the device is expected to function.
* * * * *