U.S. patent number 3,871,361 [Application Number 05/449,622] was granted by the patent office on 1975-03-18 for control device for a monitor supervising a patient.
Invention is credited to Dean L. Kamen.
United States Patent |
3,871,361 |
Kamen |
March 18, 1975 |
Control device for a monitor supervising a patient
Abstract
Involved is a system in which bodily conditions of the patient,
such as his blood pressure, heartbeat, or the like, are
electronically monitored. The monitor is required to result in the
administration, preferably by intravenous injection, of a drug to
the patient to correct any change in the supervised patient's
condition indicating an emergency situation. The within invention
is a control for the monitor providing two important safeguards.
The first safeguard is that there will be an adequate refractory
period, i.e., time for the drug to take effect, between
administered doses to the patient. The second safeguard is that the
medication dosage will not be administered to the patient until
there is some assurance that the bodily function change which
occurs in the patient is of an emergency nature, rather than merely
an insignificant change which corrects itself without
medication.
Inventors: |
Kamen; Dean L. (Rockville
Centre, NY) |
Family
ID: |
23784851 |
Appl.
No.: |
05/449,622 |
Filed: |
March 11, 1974 |
Current U.S.
Class: |
600/485;
604/66 |
Current CPC
Class: |
A61M
5/00 (20130101); A61B 5/02 (20130101); A61M
5/1723 (20130101) |
Current International
Class: |
A61B
5/02 (20060101); A61M 5/172 (20060101); A61M
5/00 (20060101); A61M 5/168 (20060101); A61b
005/02 (); A61m 005/00 () |
Field of
Search: |
;128/2R,2.5R,2.5A,2.6A,214R,214E,218A,213,DIG.13 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Truluck; Dalton L.
Attorney, Agent or Firm: Bauer & Amer, P. C.
Claims
What is claimed is:
1. In a system including a monitor operatively arranged to
supervise the blood pressure and like conditions of a patient and
in response to changes in said supervised conditions to operate a
medication-administering device for said patient, a control device
for said monitor comprising means for generating a selected voltage
signal in response to a signl input thereto from said monitor, a
first timer electrically connected to continuously receive said
selected voltage signal as an input thereto for a time interval
necessary to charge a capacitor to the value of said selected
voltage, means operated by said first timer when said capacitor
thereof achieves said voltage charge to start the operation of said
medication-administering device, and a second timer operated
simultaneously with said medication-administering device for a
selected time interval and effective to prevent any successive
operation of said first timer until completion of said selected
time interval, whereby an initial medication dosage is delivered to
said patient by said medication-administering device only after the
lapse of said time interval of said first timer so as to minimize
any false indication of an emergency situation and a succeeding
dosage is delivered only after the lapse of said time interval of
said second timer which is selected in relation to the refractory
period for the medication involved.
2. An improved control device for a patient-supervising monitor as
defined in claim 1 including means for selectively varying the time
intervals of operation of said first and second timers
independently of each other.
3. An improved control device for a patient-supervising monitor as
defined in claim 2 wherein said second timer operates a circuit in
shorting relation to said capacitor of said first timer to prevent
any successive operation of said first timer until completion of
the interval of timing operation of said second timer.
4. An improved control device for a patient-supervising monitor as
defined in claim 3 wherein said simultaneous operation of said
second timer and of said medication-administering device is
initiated by an electronic pulse transmitted from said first timer
to said second timer, said transmitted pulse being used by said
second timer to initiate its own operation and also that of said
medication-administering device.
5. An improved control device for a patient-supervising monitor as
defined in claim 4 wherein said transmitted pulse to said second
timer is also used by said component to commence said operation of
said shorting circuit for the capacitor of said first timer.
6. In a system including a monitor operatively arranged to
supervise the blood pressure and like conditions of a patient and
in response to changes in said supervised conditions to operate a
medication-administering device for said patient, a control device
for said monitor comprising means for generating a selected voltage
signal in response to a signal input thereto from said monitor, a
first timer electrically connected to continuously receive said
selected voltage signal as an input thereto for a selected time
interval preparatory to emitting a control signal, means operated
by said control signal of said first timer to start the operation
of said medication-administering device, and a second timer
operated simultaneously with said medication-administering device
for a selected time interval and effective to prevent any
successive operation of said first timer until completion of said
selected time interval, whereby an intitial medication dosage is
delivered to said patient by said medication-administering device
only after the lapse of said time interval of said first timer so
as to minimize any false indication of an emergency situation and a
succeeding dosage is delivered only after the lapse of said time
interval of said second timer which is selected in relation to the
refractory period for the medication involved.
7. An improved control device for a patient-supervising monitor as
defined in claim 6 wherein said first timer includes a capacitor
and is electrically connected to continuously receive said selected
voltage signal as an input thereto for a time interval necessary to
charge said capacitor to the value of said selected voltage before
emitting said control signal.
8. An improved control device for a patient-supervising monitor as
defined in claim 7 wherein said second timer operates a circuit in
shorting relation to said capacitor of said first timer to prevent
any successive operation of said first timer until completion of
the interval of timing operation of said second timer.
Description
The present invention relates generally to the use of an electronic
monitor to supervise the bodily functions, such as blood pressure,
heartbeat, and the like, of a patient, and to initiate an
intravenous injection or other appropriate means of delivering to
the patient an appropriate drug to correct any change in said
supervised condition. More particularly, the invention relates to a
control device for the monitor which provides important medical
safeguards for the operation of the monitor.
A typical prior art patient-supervising monitor does little more
than energize a light or operate a sound alarm which prompts the
hospital staff to take whatever medical action is required to
correct an emergency situation of the patient. The doctor or nurse
then intravenously injects appropriate medication using a
conventional syringe. Although automatic syringe devices are
available, such as those of U.S. Pat. Nos. 3,456,649 and 3,623,474,
these are seldom used. Yet, their use could result in more
preciseness in the dosages administered, in greater promptness of
administration, and other such benefits that accrue when using
automatic, rather than manually, operated eqipment or devices.
Undoubtedly, the minimal use of automatic syringe devices in
conjunction with patient-supervising monitors is because there is
insufficient control by the latter of the former to guarantee the
safety of the patient.
Broadly, it is an object of the present invention to provide an
improved control for a patient-supervising monitor overcoming the
foregoing and other shortcomings of the prior art. Specifically, it
is an object to impose safeguards on the operation of the monitor
such that it does not cause an intravenous administration of a drug
unless there is an actual emergency situation involving the
patient, and following said initial administration, the succeeding
dosage occurs only after the lapse of an appropriate refractory
period, i.e., a period during which the administered drug causes
the effect desired on the patient.
A control for a patient-supervising monitor demonstrating objects
and advantages of the present invention includes a timer
electrically connected to continuously receive from the monitor an
input signal for a time interval that is of a duration to minimize
any false indication of an emergency situation, and only thereafter
transmits a signal resulting in the administration of a correcting
drug. Also after the transmission of said signal, said timer is
rendered incapable of sending a successive signal until the lapse
of another time interval, which is selected in relation to the
refractory period for the medication involved.
The above brief description, as well as further objects, features
and advantages of the present invention, will be more fully
appreciated by reference to the following detailed description of a
presently preferred, but nonetheless illustrative embodiment in
accordance with the present invention, when taken in conjunction
with the accompanying drawings, wherein:
FIG. 1 diagramatically illustrates the functions that are performed
by the control device hereof for a monitor which is in supervising
relation to a patient; and
FIG. 2 is a circuit diagram which illustrates details of said
control device.
FIG. 1 diagramatically illustrates a system in which bodily
functions of a patient 10, such as his blood pressure, the
functioning of his heart, and the like, are supervised by a monitor
12. That is, in a well understood manner, monitor 12, which may be
any one of several commercially available electronic units, is
appropriately connected in supervising relation to the patient 10
so that if there is, for example, a sudden irregularity in the
heartbeat of the patient 10, an appropriate signal 14 is
transmitted to the monitor 12. In response to the signal input 14,
the monitor 12, in turn, produces a signal 16, which in most
instances is of an electronic nature such as a pulse at a specified
voltage. Heretofore, the pulse or signal 16 did no more than
energize a light or a sound alarm which prompted the hospital staff
to take whatever action was required to correct the emergency
situation of the patient 10. In the example given, i.e., an
irregular heartbeat, a doctor or nurse might administer lidocaine
or other such drug in an effort to regulate the patient's
heartbeat. The administration of this drug in most instances would
be by a conventional syringe. However, it could also be
administered by an automatic syringe 18, preferably one having the
construction and mode of operation of that described in U.S.
application Ser. No. 375,955, filed July 2, 1973, entitled
"Medication Injection Device." While the foregoing is preferred,
use can also be made of a medication-administering device 18 of the
general type and class described in U.S. Pat. Nos. 3,456,649 and
3,623,474. For present purposes it suffices to note that the device
18 is operated by an appropriate electronic signal or pulse 20
which commences its operation during which the device 18 causes an
intravenous injection of medicine, such as the previously noted
drug lidocaine, which corrects the emergency situation of the
patient.
In accordance with the present invention, there is provided a
control device, or so-called interface unit, generally designated
22, for the monitor 12. Specifically, device 22 controls the manner
in which the monitor 12 actuates the automatic
medication-administering device 18 to correct emergency situations
of the patient 10. Using the previously noted assumed situation in
which monitor 12 senses a heartbeat irregularity in the patient 10,
which, in turn, calls for the administration of lidocaine, there
are two requisites or conditions which should be imposed in any
system involving the monitor 12 in order for said system to be
medically sound. It is these two conditions which are imposed by
the interface control device 22 of the present invention on the
monitor 12, all as will now be fully explained.
The actual time in which the medication is delivered to the patient
10 by the automatic syringe 18 may be only a matter of minutes.
However, it may be medically necessary after the delivery of this
medication that another dosage not be delivered for a much longer
period of time in order to allow the administered dosage to have
the necessary effect on the patient's body and bodily functions.
Thus, in the case of an irregular heartbeat, it is generally
understood that successive dosages of lidocaine should have an
intervening interval, known as the refractory period, of
approximately 20 minutes. As will be described in greater detail
subsequently herein, it is therefore one function of the control
device 22 that after operation of the medication-administering
device 18, that said operation be followed by a refractory period
of any selected interval before a successive operation can occur.
As noted, a refractory interval of 20 minutes would be proper for
the drug lidocaine. However, in a situation where the patient is in
an acute hypertensive condition, and the monitor 12 is supervising
the blood pressure of the patient 10, a change in the patient's
blood pressure would indicate an emergency situation for which an
appropriate drug would be administered, and that drug may further
be required to be continuously administered until there is a
favorable change in the blood pressure condition of the patient.
Thus, in this instance the refractory period is zero.
In addition to proper allowance for a refractory period, it is
necessary that the control device or interface 22 hereof also be
capable of eliminating or minimizing any false indication of an
emergency situation involving the patient 10. For example, in a
case where the monitor 12 is supervising the blood pressure of a
patient 10, a mere change in the position of the patient, from a
prone to a sitting-up position, could cause a momentary change in
the patient's blood pressure. This change, however, is not
medically significant and consequently should not, in a properly
functioning system, initiate any corrective action, i.e., it should
not result in the commencement of the device 18 insofar as the
delivery of drugs by it to the patient. In a manner which will be
described in detail subsequently, it is therefore another important
function of the control device 22 hereof to minimize the occurrence
of any false indications of an emergency situation involving the
patient 10.
The interface or control device 22 hereof includes a selected
voltage generator 24, a first timer 26, a second timer 28, and a
control unit 30 which is operated by the second timer and exercises
control over the operation of the first timer 26. The manner in
which the foregoing components of the interface 22 operate will
become apparent as the description proceeds.
The selected voltage generator 24, as the name implies, functions
by emitting an electronic signal 32 of any selected specific
voltage, such as for example, 5 volts. The five-volt pulse 32 is
emitted continuously by the generator 24 as long as the generator
receives an input signal 16. It should be noted that the signal 32
is at a selected five volts even though the input signal 16 is at a
greater or lesser voltage. This functioning of the generator 24 is
readily understood and can be readily obtained from any number of
commercially available generators which emit an output signal at
any selected voltage. One such commercially available model used
with good results in accordance with the present invention is that
available from Signetics, Inc., of Sunnyvale, Calif. This model
advantageously utilizes a zenor diode voltage clipping circuit and
a Schmidt trigger to produce the five volt output signal 32 for as
long as there is an input signal 16 to the generator.
Reference should now be made to the circuit diagram of FIG. 2 in
order to better understand how the first timer 26 utilizes the 5
volt signal input 32 to achieve the two essential operating
conditions for the system previously alluded to. Timer 26 includes
a variable resistor 34 and a capacitor 36, the latter being deemed
fully charged when the voltage across its plates reaches the value
of nearly five volts of the input signal 32. It is helpful at this
point in the description to refer to a mechanical analogy in regard
to the operation of the timer 26. Specifically, electron flow or
current may be analogized to a flowing stream, the variable
resistor 34 to a valve which regulates the amount of fluid which is
permitted to flow past a constriction, and the capacitor 36 to a
container or receptacle having a specified volume. Thus, depending
on the setting of the variable resistor 34, there will be a certain
current flow 32 through the resistor 34 that will take a specified
amount of time to "fill" the capacitor 36, or to impress the rated
5 volt charge on this component. It is only after this interval of
time has elapsed, that the timer 26 will produce an output signal
38 of 5 volts which ultimately results in the operation of the
automatic syringe 18 in a manner which will soon be described. From
what has been described thus far, however, it should be readily
appreciated how the timer 26 imposes a time interval between the
input of the signal 32 into the timer 26 and the generation
therefrom of an output signal 38. As a consequence, the timer 26 is
effective in minimizing operation of the medication-administering
device 18 except when required to rectify or correct a real
emergency situation involving the patient 10. Specifically, the
variable resistor 34 is set at that setting which requires an
appropriate time interval before the signal 38 is produced by the
timer 26, and this contributes to eliminating any false indications
of emergency. What this actual time interval is will depend on the
bodily function being supervised by the monitor 12 and the medical
situation that the patient finds himself in. For example, if it is
the blood pressure that is being supervised by the monitor 12, a
change in this condition which occurs only for a short duration is
probably symptomatic of the patient merely changing his bed
position, i.e., getting up from a prone position, rather than an
emergency situation requiring the administration of a correcting
drug. Thus, by setting the resistor 34 so that the intervening time
interval is three minutes that a continuous signal 32 must be
received by timer 26 before it produces an output signal 38 this
imposed condition will, for all practical purposes, eliminate any
false indications of a patient emergency situation.
Reference should now be made again to FIG. 1 for a continuation of
the description of the mode of operation of the interface 22.
Assuming that the signal 32 input into the first timer 26 is for a
duration which is symptomatic of an emergency condition in the
patient 10, this will result, in the manner just described, in the
generation by timer 26 of an output signal 38 which is transmitted
to the second timer 28. Timer 28 may be any one of several
commercially available electronic timers, one such suitable timer
being available from RCA, of Harrison, N.J. Upon the receipt of the
input signal 38 by the timer 28, three events occur. The first is
the generation by the timer 28 of the previously noted signal 20
which is transmitted to the medication-administering device 18 and
which results in its dose-delivering operation. Typically, this
might be achieved in a comparatively short interval, such as 2
minutes. Simultaneously with this, the second timer 28 also
commences its own timing operation. In the example given, the
interval of this operation is 20 minutes or the equivalent of the
refractory period for the drug lidocaine which it was assumed was
being administered by the device 18 to the patient 10. A third
event required of the timer 28 is to impose an operating condition
on the system which, in effect, renders it impossible for another
output signal 38 to be transmitted to the timer 28. This must be
prevented for the 20 minute refractory period, since any output
signal 38 correspondingly results in signal 20 causing operation of
the device 18. To achieve this functioning in the timer 28, it is
provided that in response to the input to it of the signal 38 that
timer 28 emit an electronic signal or pulse 40 which is transmitted
to the control 30 for the first timer 26. Referring to FIG. 2, it
is shown that the first timer control 30 is, in effect, a short
circuit consisting essentially of a transistor, or as shown a triac
42 which is connected in short circuit relation to the capacitor
36. Signal 40 is transmitted to the biasing plate of the triac 42
and is effective in placing it in charging condition, thereby
completing the connection of circuit 44 to ground and resulting in
an alternate path for the electronic flow of the signal 32 exiting
from the variable resistor 34. As generally understood, under these
circumstances it is not possible to charge the capacitor 36, and
therefore another output signal 38 will not be generated by the
first timer 26 until the signal 40 from the second timer is
discontinued. Naturally, signal 40 is continued for the duration of
the refractory period for the drug being administered to the
patient 10, and thus the first timer 26 is rendered inoperative for
said refractory period. In this way, the interface or control
device 22 imposes a time interval, corresponding to the refractory
period for the medication involved, between successive generations
by the first timer 26 of signals 38.
From the foregoing description, it should be readily appreciated
that the interface or control device 22 thus contributes to a
system, involving a monitor 12 which supervises the bodily
functions of a patient 10, two important and significant
safeguards. The first safeguard is that there will be an adequate
refractory period between administered doses to the patient. The
second safeguard is that the medication dosage will not be
administered to the patient until there is some assurance that the
condition which occurs in the patient requiring said medication is
of a sufficient duration to indicate an emergency medical
situation, rather than merely a temporary change in the supervised
bodily function which is of a non-emergency status.
A latitude of modification, change and substitution is intended in
the foregoing disclosure, and in some instances some features of
the invention will be employed without a corresponding use of other
features. Accordingly, it is appropriate that the appended claims
be construed broadly and in a manner consistent with the spirit and
scope of the invention herein.
* * * * *