U.S. patent number 3,698,398 [Application Number 05/087,387] was granted by the patent office on 1972-10-17 for rate-scanning pacer for treatment of tachycardia.
This patent grant is currently assigned to American Optical Corporation. Invention is credited to Barouh V. Berkovits.
United States Patent |
3,698,398 |
Berkovits |
October 17, 1972 |
RATE-SCANNING PACER FOR TREATMENT OF TACHYCARDIA
Abstract
An externally activated implantable rate-scanning heart pacer.
Apparatus is disclosed for supplying to the heart of a patient a
burst of stimulating pulses in which each successive interval
between pulses of the burst is different in duration from the next
previous interval. All of these intervals can correspond to
repetition rates that lie within the physiological heartbeat range
of the patient. The pacer comprises terminals for connection to the
heart, a controllable electrical stimuli generator controlled
internally by a discharging capacitor and controlled externally by
a magnet. The pacer is particularly applicable to the treatment of
paroxysmal supra-ventricular tachycardias, a rapid heartbeat
condition originating in the atrium. The pacer can be temporarily
activated by the patient.
Inventors: |
Berkovits; Barouh V. (Newton
Highlands, MA) |
Assignee: |
American Optical Corporation
(Southbridge, MA)
|
Family
ID: |
22204883 |
Appl.
No.: |
05/087,387 |
Filed: |
November 6, 1970 |
Current U.S.
Class: |
607/15 |
Current CPC
Class: |
A61N
1/3621 (20130101); A61N 1/362 (20130101); A61N
1/37 (20130101) |
Current International
Class: |
A61N
1/362 (20060101); A61n 001/36 () |
Field of
Search: |
;128/419P,419R,421,422,423 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
|
|
|
|
|
|
|
985,797 |
|
Mar 1965 |
|
GB |
|
1,444,363 |
|
May 1966 |
|
FR |
|
Other References
Bilgutay et al., "Journal of Thoracic & Cardiovascular
Surgery," Vol. 56, No. 1, July 1968, pp 71-82 .
Davies "British Institute of Radio Engineers-Journal" Vol. 24, No.
6, December 1962, pp. 453-456.
|
Primary Examiner: Kamm; William E.
Claims
What is claimed is:
1. A heart pacer for stimulating the heart of a patient, said pacer
comprising terminal means for connection to the heart of said
patient, pulse generator means for generating electrical stimuli on
said terminal means at a varying repetition rate within the normal
physiological heartbeat rate-range of said patient, said pulse
generator means including means for automatically maintaining each
interval between stimuli different in duration from the next most
previous interval and from the next successive interval.
2. A heart pacer as recited in claim 1 and wherein said pulse
generator means includes rate increasing means for causing said
rate to continuously increase.
3. A heart pacer as recited in claim 1 and wherein said pulse
generator means includes rate decreasing means for causing said
rate to continuously decrease.
4. A heart pacer as recited in claim 1 further comprising control
means for controlling duration of operation of said pulse generator
means.
5. A heart pacer as recited in claim 4 and wherein said control
means comprises a reed switch and a magnet, the field of said
magnet arranged to operate said switch.
6. A heart pacer as recited in claim 5 and wherein said pacer,
except for said magnet, is implantable within said patient and said
magnet is adapted to be positioned externally adjacent said
patient.
7. A heart pacer as recited in claim 1 further including a self
varying source of voltage and said pulse generator being energized
by said self-varying source of voltage.
8. A heart pacer as recited in claim 4 and wherein said control
means includes automatic means for automatically terminating the
generation of said stimuli after a predetermined time.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
The subject matter of the present invention is related to the
following three copending applications: Ser. No. 810,519, filed
Mar. 26, 1969 which has matured into U.S. Pat. No. 3,595,242,
entitled "Atrial and Ventricular Demand Pacemaker;" Ser. No.
884,825, filed Dec. 15, 1969, entitled "Atrio-Ventricular Pacer
with Atrial Stimuli Discrimination," and Ser. No. 71,799 filed
Sept. 14, 1970 entitled "Stimulator for Treatment of Tachycardia."
Information disclosed in these three patent applications is
incorporated herein by reference.
These applications were filed by the applicant of the present
invention. All of these applications, including the present
application, are assigned to the same assignee. Benefits of 35 USC
120 are claimed for the present invention with respect to the
earlier applications.
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates in general to electrical pacing of a
heart. More particularly, the present invention relates to
electrical stimulation of the atria or ventricles of the heart for
treating paroxysmal supra-ventricular tachycardia.
2. Description of Prior Art
The PQRST wave form complex depicted by electro-cardiograms is well
known in the electro-medical art. The QRS portion of the wave form
complex is associated with the ventricular action of the heart. The
P-wave is associated with the atrial action of the heart. Toward
the end of each heartbeat, the ventricular muscles repolarize, and
this portion of the electrical activity of the heart corresponds to
the T-wave in the electro-cardiogram.
A typical frequency of occurrence of the wave form complex, or
heartbeat rate, when the patient is at rest, is in the neighborhood
of 70 times per minute. However, the frequency of occurrence of the
wave form complex, due to improper heart functioning can exceed 160
occurrences per minute. This excessive rapidity of the heart's
action is known as "Tachycardia." However, it should be understood
that the physiological range with regard to normal heartbeat rate
can vary considerably between individuals. For example, a child can
have a normal physiological range comprised of heartbeat rates
considerably higher than those of an adult.
"Atrial tachycardia" is the medical term assigned to the condition
in which rapid and regular succession of P-waves of the wave form
complex occur. The rate of occurrence is in excess of the
physiological range of the particular patient.
"Paroxysmal supra-ventricular tachycardia" is the medical term
assigned to the condition in which there is a sudden attack of
rapid heart action in the atria or in the atrial-ventricular node.
The main characteristics are the same as those in atrial
tachycardia.
In normal heart operation the electrical activity begins with a
nerve impulse generated by a bundle of fibers located in the
sino-atrial node. The impulse spreads across the two atria while
they contract and speed the flow of blood into the ventricle
underneath them. The electrical impulse continues to spread across
the atrial-ventricular node, which in turn stimulates the left and
right ventricle.
During normal heart operation, tachycardia can arise when peculiar,
unique conditions occur unpredictably. These conditions are
associated with geometry of the atria, location of the nerve
impulse, timing of the beat and impulse conduction velocity within
the cardiac tissue. These conditions can set up a re-entry
mechanism in the atria, for example, whereby the impulse continues
to self-perpetuate. The self-perpetuation occurs at a rate above
the physiological rate and is self-sustaining even after the
"unique condition," (which permitted it to start), no longer
exists. The self-perpetuation must then be interrupted by outside
intervention interfering with the re-entry mechanism, thus
permitting the heart to resume normal sequence.
Presently, treatments of the conditions of tachycardia include the
mechanical message of the carotid sinus. This is an accepted
therapy. however it has several drawbacks. For example, it requires
a trained physician, who may not be readily available, to
administer the massage.
Another treatment for tachycardia employs the use of drugs.
However, this therapy has toxic effects on the body.
The self-perpetuation can be interrupted by electrical stimulation
occurring at a critical time interval that is dependent on the
patient's physiological condition at that time. The critical
interval required is not predictable. Thus, one can apply a burst
of stimuli, as was previously disclosed in my copending application
Ser. No. 71,799, to the heart and for example to the right atrium
to interrupt the self-perpetuating mechanism by interacting with
the abnormal spread of an electrical impulse generated in the right
atrium. Similarly, the stimuli could be applied to a ventricle. The
stimuli were generated at a rate above the normal physiological
heartbeat rate range. In particular embodiment, the stimuli were
generated at a rate in the neighborhood of 1,000 per minute for a
period of approximately 5 seconds duration. This amounts to
individual bursts of approximately 83 pulses. Thus, some of the
stimuli in the burst are properly spaced from each other to satisfy
the critical interval.
However, the high repetition rate burst cannot be applied to all
patients. In some patients with abnormal passways (such as a Kent
bundle) the ventricle could respond to many of the fast stimuli,
and produce a fast ventricular rate. In these patients, a high
repetition rate burst of stimuli is dangerous and could result in
fibrillation. Fibrillation can be fatal. The present invention is a
therapeutic solution for these patients.
The present invention relates to a repetition rate scanning pacer
that could be within the normal physiological rate range. the
scanning pacer changes the interval between successive stimuli in a
progressive manner. One of the increasing (or decreasing) intervals
in the succession of intervals is expected to be the critical
interval that will allow interruption of the paroxysmal tachycardia
mechanism. Because the repetition-rate range can lie within the
normal physiological rate range (i.e., 50 to 150 stimuli per
minute) there is no danger to patients with abnormal passways. The
pacer has no distinct rate.
SUMMARY OF THE INVENTION
The present invention relates to an externally activated
implantable heart pacer for providing a series of stimulating
pulses to the heart of a patient to treat a condition of
tachycardia. The present invention incorporates an electrical
stimuli generator and a control for controlling the generator. The
stimuli are conducted to the heart via implantable terminals or
electrodes. The control incorporates an external magnet and an
implanted magnetic reed switch.
Advantages of the present invention include immediate and
self-initiated treatment. The patient can sense when tachycarida
occurs by his dizziness, perspiration and weakness. The patient can
recognize these symptoms readily. Instead of going to a hospital
for treatment, as is usually necessary at present, the patient can
apply stimulation himself via an externally controlled implanted
stimulator.
It is thus an object of the present invention to provide a new
treatment for the physiological condition known as tachycardia, and
more particularly for the physiological condition known as
paroxysmal supra-ventricular tachycardia.
It is another object of the present invention to provide a new and
improved heart pacer.
It is a further object of the present invention to provide a pacer
for providing a burst of stimuli to the heart of a patient, where
the repetition rate is self-controlled and can lie within the
patient's physiological rate range.
Other objects and advantages of the present invention will become
apparent to one having reasonable skill in the art after referring
to the detailed description of the appended drawings herein:
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a block diagram of an illustrative embodiment of the
present invention indicating the implantable stimulator and
external magnet; and
FIG. 2 is a schematic diagram of the circuit of an illustrative
embodiment of the present invention.
DESCRIPTION OF THE PREFERRED EMBODIMENT
In FIG. 1, a functional block diagram of an illustrative embodiment
of the present invention is depicted. Oscillator control 11
controls oscillator 12 as shown. Oscillator 12 triggers stimuli
pulse generator 13 once with each oscillation. Stimuli pulse
generator 13 provides an electrical stimulus to heart 14 with each
oscillation. Heart 14 is stimulated in response thereto. Control
11, oscillator 12, generator 13, and heart 14 are depicted as
enclosed by phantom line 10. Phantom line 10 is intended to
represent the surface of a patient in whom the stimulator is
implanted. Magnet 15 is depicted as external to the patient. It is
positioned in close proximity to the oscillator control 11, and
dashed line 16 is intended to indicate the dependence of oscillator
control 11 on magnet 15.
FIG. 2 is a circuit diagram of an illustrative embodiment of the
present invention. Batteries 3 through 7 are connected in series
aiding. (The dashed line between batteries 3 and 7 indicate that
the exact number of batteries used may vary.) The positive terminal
of battery 7 is connected to the junction of one end of resistor 23
and one end of resistor 24. The negative terminal of battery 3 is
connected to a junction comprised of one side of capacitor 28, the
emitter of transistor T9, electrode E2, one end of resistor 25, and
one end of resistor 63. The other end of resistor 23 is connected
to terminal 30 of reed switch 32. Reed element 31 makes contact
with terminal 30 in the normally closed position, and connects
terminal 30 with the other side of capacitor 28.
Terminal 29 is the normally open contact of reed switch 32, and is
connected to the junction consisting of one end of resistor 35 and
the anode of diode 27. The cathode of diode 27 is connected to the
anode of diode 26 whose cathode is connected to a junction
comprised of resistor 25, the base of transistor T7, and the
collector of transistor T8. The other end of resistor 35 is
connected to the emitter of transistor T7 and to one end of
resistor 37. The collector of transistor T7 is directly connected
to the base of transistor T8.
The other end of resistor 37 is connected to one side of capacitor
57 the other side being connected to a junction consisting of the
emitter of transistor T8 and one end of resistor 61. The other end
of resistor 61 is connected to a junction comprised of the other
end of resistor 63 and the base of transistor T9. The collector of
transistor T9 is connected to a junction comprised of the other end
of resistor 24, and one side of capacitor 65. The other side of
capacitor 65 is connected to electrode E1. Electrodes E1 and E2 are
both connected to heart 14.
In operation, consider reed switch 32 to initially be in its
normally closed position as depicted. In this position, capacitor
28 charges to a value of voltage equal to the sum of potentials of
the batteries or to full battery voltage. The charging circuit
includes resistor 23, the contact made between terminal 30 and reed
element 31, and capacitor 28.
When reed element 31 is in the position depicted, there is no
energization provided to the circuitry to the left of capacitor 28.
Thus, transistor T9 is non-conducting because of zero base current
and T9 behaves like an open switch. The open switch maintains
capacitor 65 charged to full battery voltage. Resistor 24,
capacitor 65, electrode E1, heart 14, electrode E2 and the
conductive path returning to the negative terminal of battery 3
comprise a charge path for capacitor 65. Capacitor 65 charges
through the heart. The relatively slow charging of capacitor 65,
(due to resistor 24,) through the heart does not cause any
stimulation to the heart. (It is the rapid discharge of capacitor
65, to be described later, which provides stimulation to the
heart.)
Thus, two charge paths exist, and capacitors 28 and 65 are each
charged to and for this condition remain at the total battery
potential. But, when reed element 31 is caused to make contact with
terminal 39, a different situation exists.
Consider magnet 15 to be brought in close proximity to magnet reed
switch 32. This causes element 31 to move and to make contact with
fixed terminal 29. Circuit operation may best be understood by
assuming that magnet 15 is held in close proximity to switch 32 so
that element 31 is in contact with terminal 29 for a sufficient
period of time for capacitor 28 to substantially discharge to a
predetermined voltage.
Upon contact between element 31 and terminal 29 charged capacitor
28 becomes the effective D.C. power supply for the circuitry to its
lefthand side in the diagram. However, the charged capacitor is an
unusual D.C. power supply in the sense that its "output" voltage is
a decreasing function of time rather than a fixed function of time.
Thus, at some predetermined time during discharge of capacitor 28
through the circuitry to its left, the capacitor voltage will fall
below some predetermined voltage that is required to maintain
operation of the circuitry to its left.
Considering circuitry to the left of capacitor 28, the series
circuit of diode 27, 26 and resistor 25 establish a biasing network
for transistor T7 and T8. Current flow from capacitor 28 through
both diodes and resistor 25 establish a potential at the cathode of
diode 26 that is approximately 1 volt less than voltage at the
anode of diode 27. This voltage difference is due to the forward
voltage drop of diodes 26 and 27 being approximately 0.5 volts each
and being approximately constant for different forward current
values. There is nothing unique about 1.0 volts. An approximately
constant 1.2 volts would work equally well. The actual value of
voltage drop is a function of the diodes employed, (As voltage on
capacitor 28 decreases, current through resistor 25 decreases but
the 1-volt drop across the diodes remains approximately constant.)
This voltage at the cathode of diode 26 is a threshold voltage
which must be exceeded by voltage at the emitter of transistor T7
by approximately 0.5 volts (since the base-emitter junction of
transistor T7 requires a forward bias voltage similar to the 0.5
volt drop of the diodes) before transistor T7 and T8 conduct.
Capacitor 57 charges through resistors 35 and 37 until the voltage
across it causes transistors T7 and T8 to conduct. Transistors T7
and T8, connected as shown, operate in a similar fashion to that of
a silicon controlled rectifier. Both are normally non-conducting.
When the emitter electrode of transistor T7 goes sufficiently
positive to exceed threshold voltage at the base of transistor T7
by approximately 0.5 volts, the transistors conduct and current
flows through the emitter circuit of transistor T8. Current coming
from both capacitors 28 and 57 continues to flow through the
emitter of transistor T8 until the potential difference between the
emitter and base of transistor T7 drops below approximately 0.5
volts due to sufficient discharge of capacitor 57. Note that the
current drain from capacitor 28 during this operation contributes
to its discharge.
When transistors T7 and T8 stop conducting, capacitor 57 is made to
charge from the value of voltage across it at the time of turn off
of these transistors toward a "new" (and lower) value of voltage on
capacitor 28. When the voltage across capacitor 57 is sufficiently
positive, transistors T7 and T8 conduct once again and the cycle is
repeated. This circuitry comprises an oscillator and can be thought
of as a type of relaxation oscillator.
The frequency of this particular oscillator increases with each
cycle of oscillation (or the time interval between each stimuli
pulse decreases with each cycle). The oscillator has no distinct
rate. The reason for this decrease of interval with each cycle is
due to unequal rates of voltage decrease at the base and at the
emitter of transistor T7. The voltage drop across diodes 27 and 26
are approximately constant and the voltage at the cathode of diode
26 (the base of T7) decreases at the same rate as the voltage
decrease on capacitor 28. But, the voltage at the emitter of
transistor T7 decreases at a slower rate due to voltage divider
action of resistors 35 and 37. Although the base and emitter
voltages of transistor T7 both decease as capacitor 28 discharges,
the base voltage decreases faster. Thus, transistor T7 returns to a
conducting state sooner due to earlier forward biasing of its
base-emitter junction with each cycle.
Voltage at the junction of resistors 35 and 37 varies with voltage
on capacitor 57. Capacitor 57 charge time is primarily determined
by resistors 35 and 37; its discharge time is primarily determined
by resistor 37. Resistors 35 and 37 are in the charge path of
capacitor 57 but only resistor 37 is in the discharge path.
With each oscillation, the "power supply voltage" provided by
capacitor 28 is decreased in value. Thus after a predetermined
period of time, capacitor 28 will "run down" to a predetermined
voltage and there will be insufficient energy stored in capacitor
28, in view of the biasing constraints imposed by its "load"
circuitry, to provide another single oscillation. At this point,
there will be no further energizations supplied to the heart unless
capacitor 28 is recharged.
When the magnet is removed, by spring action or other means,
element 31 moves back to its normally closed contact element 30.
Thus, the position of magnet 15 controls the state of switch
32.
If magnet 15 were removed prior to capacitor 28 discharging to the
predetermined voltage (where it no longer acted like a power
supply), reed switch 31 would have been returned to its normally
closed contact earlier in time. Thus, the number of stimulations
supplied to the heart would have been reduced, and capacitor 28
would have been recharged.
Thus, there are two controls over the oscillator. First, if magnet
15 is held in position long enough, a finite number of oscillations
are allowed beyond which no further oscillations are permitted
unless the magnet is removed to allow capacitor 28 to recharge.
Second, the number of oscillations can be controlled or limited by
removing the magnet prior to discharge of capacitor 28 to the
predetermined voltage.
Transistor T9 is a simple current amplifier which is normally
non-conducting. When transistor T8 conducts the emitter current
flowing through resistors 61 and 63 causes the potential at the
base of transistor 59 to increase.
At such a time, transistor T9 is biased to conduction and capacitor
65 can discharge through it through the heart. Capacitor 65
discharges more rapidly than it charges since resistor 24 is not
involved in the discharge path. Capacitor 65 discharges through an
essentially short circuited transistor switch. Transistor T9
operates in response to each oscillation. The combination of the
oscillator, transistor T9, and capacitor 65 comprise a pulse
generator.
The frequency (repetition-rate) range can be made as large as
desired. It can be made to scan through a wide range from below the
physiological rate range to above the physiological rate range.
However, for a patient with abnormal passways, the range is limited
to within the physiological rate range of that patient. A typical
rate range would be 90 to 130 cycles per minute.
After magnet 15 is removed, reed switch 32 assumes the depicted
state. Capacitor 28 is recharged and capacitor 65 is recharged as
previously described. Only if the patient or another person places
magnet 15 in proper position once again will there be another burst
of stimuli to the heart. The patient can perform this operation
himself in response to an uncomfortable feeling when he goes into
tachycardia. (Paroxysmal supra-ventricular tachycardia is a
disorder which is not lethal but which does cause temporary
discomfort to the patient.) When the magnet is in position once
again, capacitor 28 assumes its role as power supply and once again
a burst of stimuli is applied to the heart.
If a second burst is needed, in the event that one burst did not
interrupt the re-entry mechanism, the decreasing intervals in the
second burst will not correspond exactly in duration to the
decreasing intervals in the first burst. This difference (although
slight) is attributed to variations in the semiconductors due to
some self-heating, and to variations in the amounts residual
voltage on the capacitors. This change in corresponding intervals
between bursts is usually desirable as it can result in a greater
liklihood of the critical interval occurring during the second
burst. Also, the patient's critical interval requirements may vary
between bursts, i.e., the critical interval required by the patient
can vary from burst to burst which can further enhance the chance
of the pulse generator's supplying pulses at the critical
interval.
The invention may be embodied in other specific forms without
departing from the spirit or essential characteristics thereof. For
example, the oscillator need not be of the relaxation variety, the
output could be transformer coupled, and other means for
controlling turn on and turn off of the oscillator could be
employed. It should be understood that other biasing arrangements
could be used so that the frequency of oscillation could decrease
instead of increase, and could even randomly increase or decrease.
The essential requirement is to cause the critical interval to
occur.
The present invention can, of course, be extra corporeal (external)
having the terminals implanted or the entire mechanism, with the
exception of the control, can be implanted.
The present embodiments are therefore to be considered in all
respects as illustrative and not restrictive, the scope of the
invention being indicated by the appended claims rather than by the
foregoing description, and all changes which some within the
meaning and range of equivalency of the claims are therefore
intended to be embraced therein.
* * * * *