U.S. patent number 3,896,817 [Application Number 05/277,963] was granted by the patent office on 1975-07-29 for implantable nerve stimulator.
This patent grant is currently assigned to Arco Nuclear Company. Invention is credited to Thomas F. Hursen, Steve Andrew Kolenik.
United States Patent |
3,896,817 |
Hursen , et al. |
July 29, 1975 |
Implantable nerve stimulator
Abstract
An implantable stimulator for a nerve includes a voltage
amplifier, a voltage regulator, a pulse generator, a pulse train
generator, a pulse amplitude modulator, and at least one flexible
conduit to a nerve, such stimulator being powered by the
combination of a nucleonic heat generator, and a thermopile for
converting thermal energy to electric energy. Each train of pulses
is regulated so that the gradual variation in the amperage is from
25 per cent to 95 per cent more than the minimum amperage. A saw
tooth pulse signal more closely simulates the biological
stimulation of a nerve. The nerve stimulator is particularly
effective as a nuclear-powered respiratory pacer for energizing a
phrenic nerve for controlled breathing of a mammal.
Inventors: |
Hursen; Thomas F. (Monroeville,
PA), Kolenik; Steve Andrew (Leechburg, PA) |
Assignee: |
Arco Nuclear Company
(Leechburg, PA)
|
Family
ID: |
10394170 |
Appl.
No.: |
05/277,963 |
Filed: |
August 4, 1972 |
Foreign Application Priority Data
|
|
|
|
|
Aug 6, 1971 [GB] |
|
|
37151/71 |
|
Current U.S.
Class: |
607/42;
607/70 |
Current CPC
Class: |
A61N
1/378 (20130101); A61N 1/3601 (20130101) |
Current International
Class: |
A61N
1/372 (20060101); A61N 1/36 (20060101); A61N
1/378 (20060101); A61n 001/36 () |
Field of
Search: |
;128/419P,419R,421,422,423,28 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Primary Examiner: Kamm; William E.
Attorney, Agent or Firm: Ewbank; John R.
Claims
The invention claimed is:
1. In a respiratory pacer, the combination of:
a nuclear battery providing several years of useful life;
electrical means converting electrical power from said battery to a
series of signals having a frequency per minute corresponding
approximately to the desired breathing rate, each signal comprising
a plurality of direct current pulses, one output terminal being a
connector and the other output terminal for said electrical means
being the hereinafter recited casing adapted to contact liquids
between organs within the body, some such liquids being where the
pacer is implanted, said electrical means including means for
modulating the amperage of a signal so that its maximum amperage is
within the range from about 125 per cent to about 195 per cent of
the minimum amperage of such signal;
at least one conductor transmitting signals from said connector
toward a phrenic nerve; and
a casing containing said battery, electrical means, and said
connector for said conductor, said casing hermetically sealing its
contents from adverse effects attributable to said liquids, whereby
the respiratory pacer may be implanted within a living body.
2. In an implantable nerve stimulator comprising at least one
conductor transmitting signals toward a nerve, the improvement
which includes:
a casing;
hermetic sealing means for said casing adapted to protect the
contents of the casing from adverse effects attributable to liquids
between organs;
a nucleonic battery within the casing;
means conducting current from said battery to the hereinafter
recited circuit means; and
electrical circuit means converting electrical power from said
battery to signals consisting of a controlled train of direct
current pulses transmitted by said conductor, said circuit means
including means for modulating the amperage of a signal so that its
maximum amperage is within the range from about 125 per cent to
about 195 per cent of the minimum amperage of such signal.
3. The nerve stimulator of claim 2 in which the train of pulses
constituting said signal has a sawtooth pattern with maximum
amperage at about the terminal portion of the signal and a minimum
amperage at about the initial portion of the signal.
4. The nerve stimulator of claim 2 in which there are a plurality
of conductors and manually adjustable distribution means allocating
the signal energy flowing respectively toward the right phrenic
nerve and the left phrenic nerve.
5. A nuclear powered respiratory pacer in accordance with claim 2
in which the output flowing toward at least one phrenic nerve is
within the range from about 1 to about 5 milliwatts.
6. A nuclear powered respiratory pacer in accordance with claim 5
in which the nuclear battery weighs about 92 grams and contains
plutonium 238 as the radioisotope heat source.
Description
CROSS NOTATION TO CONVENTION APPLICATION
Reference is made to British Provisional application 37,151 of 1971
filed Aug. 6, 1971 on License No. 351,021 issued July 6, 1971,
applicant claiming convention priority. All the disclosure of said
37,151 is deemed here reiterated. Reference is made to U.S. Pat.
No. 3,818,304, derived from Ser. No. 171,383 and parent Ser. No.
827,187, filed May 23, 1969, assigned to common assignee, Atlantic
Richfield Company, of which this is a continuation-in-part,
disclosing some embodiments of nuclear batteries of sufficient
power for a respiratory pacer.
FIELD OF THE INVENTION
This invention relates to prosthetic electrical devices which can
be placed within the body to provide electrical signals effectively
stimulating a nerve.
PRIOR ART
Some disfunction in mammals are attributable to the reliability of
a controlled frequency of nerve stimulations for actuating
appropriate muscles. Cardiac pacers have been helpful in dealing
with certain disfunctions of the heart attributable to neurological
problems. The breathing disfunction of a neurological nature are
similarly dealt with by respiratory pacers stimulating one or more
of the phrenic nerves at appropriate intervals. Significant greater
wattage is required in a respiratory pacer than in a cardiac
pacer.
An implantable cardiac pacer featuring a nuclear battery has
heretofore been proposed in the commonly assigned patent
application U.S. Ser. No. 109,857, (now abandoned and replaced by
Ser. No. 325,473) all the disclosure of which is deemed here
reiterated. A lecture providing background information concerning
respiratory pacers was presented at the American Association for
Thoracic Surgery by Seymour Furman et al, entitled "Transvenous
Stimulation of the Phrenic Nerves" about Apr. 27, 1971, all the
disclosure of which is deemed here reiterated. Although there has
been a recognition that the phrenic nerve sometimes benefited from
stimulation by a pacer, there had not been any answer to the
problem of an implantable phrenic nerve stimulator prior to the
development of the present invention.
SUMMARY OF THE INVENTION
In accordance with the present invention, a nerve pacer comprises
the combination of a nuclear battery, an electrical pulse train
generator, and a modulator adapted to provide a signal having a
maximum amperage at least 25 per cent greater but not more than 95
per cent greater than the minimum amperage of such signal, whereby
the nerve is stimulated by a signal which varies in a manner
achieving a desired biological effect. An implantable nerve
stimulator features the combination of a nuclear battery and
electronic circuitry providing signals consisting of a train of a
controlled number of pulses of direct current. An implantable
respiratory pacer having an output of a range of from about 1 to 5
milliwatts and powered by a nuclear battery stimulates one or more
phrenic nerve to provide a controlled rate of breathing for the
mammal.
DRAWING
A schematic plan for the apparatus is shown in the drawing. In the
drawing, which is essentially self-explanatory, a respiratory pacer
10 features a nuclear battery 11. Within the nuclear battery, a
radioisotope heat source 12 energizes a thermopile 13 to generate a
voltage energizing the respiratory pacer. The battery voltage is
modified by a voltage amplifier 14 and a constant voltage regulator
15. Electrical circuit means energized by the voltage from said
regulator 15 energizes a pulse generator, the electrical circuitry
for such pulse generator comprising an oscillator. A pulse train
generator 17 assures the absence of current flow during significant
intervals, with a train of pulses between intervals, for example,
18 intervals per minute, corresponding to a relaxed breathing rate.
A signal amperage modulator 18 transforms each train of pulses into
a saw tooth signal having an end peak from 125 per cent to 195 per
cent to the initial portion of such signal, thus more nearly
simulating the natural signal to a phrenic nerve. Conductors 19 and
20 transmit such saw tooth signal to left and/or right phrenic
nerves. The electrical circuit means and nuclear battery are
hermetically sealed in a casing 21.
As seen in the flow pattern, the combination of radioisotope
thermopile, and voltage amplifier to provide a source of useful
voltage is consistent with prior teachings concerning nucleonic
powered cardiac pacers. The combination of a constant voltage
regulator and a pulse generator is also previously taught in
connection with nerve stimulators.
The provision of a pulse train generator to provide a signal
consisting of a controlled series of direct current pulses is a
novel feature of the present nerve stimulator.
The step of modulating the amperage to provide a saw tooth signal
having an end peak from 125 per cent to 195 per cent of the initial
portion of a signal is a novel and significant forward step of the
present invention.
Previous nerve stimulators have generally lacked the novel
adjustable means for allocating electrical energy amongst a
plurality of conductors, so that the provision of the load
isolation and distribution regulator should be given special
consideration.
This invention represents a medical break-through as the first
device adapted for placement or implantation within the body and
featuring the combination of nucleonic battery and a conduit
stimulating the phrenic nerve. The unique nuclear battery makes
feasible the first respiratory pacer sufficiently durable and
compact to be carried within the body after surgical
implantation.
DETAILED DESCRIPTION OF THE INVENTION
In a preferred embodiment, the nerve stimulator serves to actuate
the phrenic nerve to provide a respiratory pacer. A radioisotope
provides a continuing radioactivity which is transformed into heat
and the heat is transformed into a low voltage electric current. A
voltage amplifier converts the DC voltage to a more useful direct
current voltage which is maintained constant by a constant voltage
regulator. A self-starting oscillator regulates the conversion of
the constant direct current to a square wave series of direct
current pulses having a frequency of about 90 pulses per second,
each pulse having a duration of about 132 microseconds.
A significant difference from a conventional cardiac pacer concerns
a pulse train generator adapted to provide a train of pulses
followed by an interval each signal being a train of pulses. For a
respiratory pacer, about 18 signals per minute are appropriate, the
interval between the signals being about 24 per cent greater than
the signal duration. Each signal can be about 1.49 seconds and the
interval between signals about 1.85 seconds.
Important advantages are attained by reason of the provision of a
signal consisting of a plurality of direct current pulses. Certain
biochemical phenomena are apparently associated with a neurological
electrical system. Although certain neurological effects can be
achieved by a signal partaking of the nature of a single electrical
pulse, better simulation of the neurological signal is achieved by
providing the train of pulsation of direct current.
An important feature of the present invention is the provision of a
modulator adapted to alter the train of pulses in a signal so that
the peak amperage during a particular signal is at least 25 per
cent greater than the minimum amperage during such signal. Various
patterns of modulation of the signal are appropirate but particular
advantages arise from the control of a saw tooth train having a
relatively lower amperage at the beginning of the signal than at
the end of the signal, with the amperage increasing during the
continuation of the signal. It is sometimes desirable for a signal
remote from this invention to have a saw tooth pattern involving an
increase which is several hundred per cent over the minimum
amperage but such a steep increase in amperage during the signal
does not appear to closely simulate a neurological signal. The saw
tooth increase modulates the signal so that the amperage of the
terminal portion of the signal of the present invention is from
about 125 per cent to about 195 per cent of the amperage of the
initial signal, whereby the simulation of the natural neurological
signal is more accurately achieved.
The disfunction impairing the operation of the phrenic nerves is
often not the same for the right phrenic nerve and left phrenic
nerve. Accordingly, a load isolation regulator is advantageously
included in the respiratory pacer to permit adjustment of the
intensity of the phrenic nerve signal for each of the two nerves;
that is, the left phrenic nerve and the right phrenic nerve. A
manually adjustable potentiometer can split the power between the
two phrenic nerves. A conductor extends from the respiratory pacer
to the phrenic nerve. Such conductor is advantageously detachably
connected to the respiratory pacer.
A preferred embodiment of the invention can be further clarified by
description of a respiratory pacer.
Nuclear Battery
Plutonium 238 has a half life of 86.4 years, and has numerous
advantages for a nuclear battery. About 2 watts of power are
generated, theoretically, by the amount of plutonium employed in
the battery, but much of the energy is dissipated. The electrical
output of the battery is of the general magnitude of the range of
0.001 to 0.005 watt, or about 1 to 5 milliwatts. The energy
utilization efficiency of the battery and/or nerve stimulator is in
the range from about 0.1 per cent to 1 per cent. A plutonium-type
battery having a size of about 11/2 inches diameter and 1 1/16 inch
thick weighs about 92 grams.
The voltage resulting from a thermocouple is amplified by a DC
voltage amplifier to provide the electric current suitable for the
electronic circuitry. The oscillator modifies the current by a
square wave series of pulses of direct current having a frequency
of about 89 pulses per second. Each pulse has a width or duration
of about 132 microseconds or 0.132 milliseconds.
A pulse train generator transforms the pulses into signals at a
range of about 18 signals per minute, the intervals between signals
being about 24 per cent greater than the duration of the signals.
The signal is about 1.49 seconds and the interval between signals
about 1.85 seconds. The maximum pulse amplitude is about 9.6
milliamps. The pulse amplitude modulation is about 54 per cent. The
maximum amperage is within the range from 125 per cent to 195 per
cent of the minimum amperage by reason of the control of the
modulation of the signal.
Casing
The respiratory pacer is hermetically sealed in a flat
cylindrically shaped titanium can having a diameter of about 23/4
inches and about 11/8 inches thick. Such hermetic sealing protects
the contents from adverse effects of liquids between organs within
the body, whereby it may be implanted within a living body. The
respiratory pacer weighs about 198 grams, thus being similar in
weight and dimensions to a battery powered cardiac pacer having an
output of about one-twentieth of the power of a phrenic nerve
stimulator.
A signal having a saw tooth shape can have a substantially uniform
increase of amperage during the 1.49 seconds of the signal. The
modulation circuitry is adapted to provide up to about 54 per cent
modulation of the maximum signal and to achieve saw tooth wave
signal. In the development of the present invention, it has been
established that the maximum amperage of the signal should be at
least 25 per cent greater than the minimum amperage of the signal,
and should be less than 95 per cent of such minimum.
It should be noted that a train of pulses which has not been
modulated tends to stimulate staccato breathing. Such unnatural
staccato breathing is harmful to the health. The modulation of the
signal to the phrenic nerve so that the amperage during the
terminal portion of the signal is significantly greater (for
example, about 50 per cent) than the initial amperage promotes a
breathing pattern which closely simulates that which the autonomic
nervous system would stimulate in a healthy individual.
Various modifications of the invention are appropriate without
departing from the scope of the appended claims.
* * * * *