U.S. patent number 3,706,308 [Application Number 05/081,653] was granted by the patent office on 1972-12-19 for life detecting medical instrument.
This patent grant is currently assigned to Neuro-Data, Inc.. Invention is credited to Erwin Roy John, Robert Laupheimer.
United States Patent |
3,706,308 |
John , et al. |
December 19, 1972 |
LIFE DETECTING MEDICAL INSTRUMENT
Abstract
An electronic medical instrument to detect the presence or
absence of life includes an electroencephalograph (EEG) and an
electrocardiogram (EKG), connected to one or more data scanners, a
stimulator, an analog or digital data analysis device such as an
average response computer, a graphic recorder, and a time stamp. A
portable version of this instrument is hand-carried and gives a
visual display indicating the presence or absence of life.
Inventors: |
John; Erwin Roy (Riverdale,
NY), Laupheimer; Robert (Westbury, NY) |
Assignee: |
Neuro-Data, Inc. (Cliffside
Park, NY)
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Family
ID: |
22165527 |
Appl.
No.: |
05/081,653 |
Filed: |
October 19, 1970 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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782863 |
Dec 11, 1968 |
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Current U.S.
Class: |
600/483 |
Current CPC
Class: |
A61B
5/332 (20210101); A61B 5/377 (20210101); A61B
5/0245 (20130101); A61B 5/291 (20210101) |
Current International
Class: |
A61B
5/0476 (20060101); A61B 5/0404 (20060101); A61B
5/0402 (20060101); A61B 5/0478 (20060101); A61B
5/0484 (20060101); A61B 5/0245 (20060101); A61B
5/024 (20060101); A61b 005/04 () |
Field of
Search: |
;128/2.6R.2.6F,2.6G,2.1R,2.1B,2.1A,2.5R,2.5S,2.5T |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Other References
British Med. Journ., Oct. 25, 1958, pp. 1005-1009. .
Thompson, N. P., Amer. Journ. of Med. Electr., July-Sept., 1962,
pp. 191-194. .
Med. & Biol. Engineering, Vol. 8, 1970, pp. 415-418..
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Primary Examiner: Howell; Kyle L.
Parent Case Text
The present invention relates to electronic medical instruments and
more particularly to such an instrument for testing if a patient is
alive. This application is a continuation-in-part of U.S.
application Ser. No. 782,863, filed Dec. 11, 1968, now abandoned,
and having the same title.
Claims
We claim:
1. A portable instrument for the detection of the presence of life
in a person, the instrument comprising a body portion, a handle
portion, a visual display means, and protruding connecting
means;
said protruding connecting means including a plurality of
electrodes adapted to be rapidly fastened to the patient;
said body portion including an electric shock stimulator means and
a timer means, said stimulator means being connected to said timer
means and to one of said electrodes to provide timed electric
shocks to the patient, an electroencephalograph amplifier means
connected to at least one of said electrodes, a data averaging
means connected to said electroencephalograph amplifier means and
said stimulator means, an electrocardiograph amplifier means
connected to at least one of said electrodes,
said visual display means being connected to said data averaging
means and said electrocardiograph amplifier means.
2. An instrument as in claim 1 and also including a
cardiotachometer in said body portion and a meter in said visual
display means connected to said cardiotachometer.
3. An instrument as in claim 1 wherein the data averaging means is
an average response computer including, connected in series, a
polarity reversing circuit, a timing circuit, an integrating
circuit and an up-down counter circuit.
4. An instrument as in claim 1 wherein at least one of said
electrodes comprises a needle connected to said
electroencephalograph amplifier means, said needle being
spring-loaded and releasable by a trigger within said handle
portion.
Description
Medical science has for several years been able to remove organs,
such as the kidney, from the body of a donor and implant them into
the body of a recipient. Recently, medical science has progressed
to the point where such transplants may even be of the heart.
Unlike some other organ transplants in which the donor may be alive
or dead at the time of the operation, heart transplants the donor
must be dead when the organ is removed. A definite test of life is
needed to guide the doctor, who may be subject to criminal
sanctions and civil liability if he removes the heart from a donor
who is still medically and legally alive.
In addition, a definition and test of life is needed in some
medical procedures, such as operations, in order to accurately
determine the extent to which the operation or other medical
procedure should be continued. There is no justification for
terminating attempts to save a patient as long as he is still
alive. Not only is this crucial for the patient, but the doctor may
subject himself to censure or liability if he stops the operations
or other medical procedures while the patient is alive since it
might later be established that, had he continued, the patient
might have recovered. Similar considerations are relevant at the
scene of accidents, on a battlefield, or in hospital emergency
rooms, particularly where skilled medical personnel may not be
present. It is therefore necessary to have a portable instrument to
provide a rapid, accurate and definite test of life so that the
medical or resuscitative procedure may be continued until the time
of death, and not wasted by continuing beyond that point, and so
that emergency transportation may be given only to live
patients.
At the present time there have been various medical indications
used to test and define death. The historical indications are the
stopping of the patient's heartbeat and the stopping of his breath.
These indications are reflected in the definition of death in
Black's Law Dictionary 488 (4th Edition, 1951) as: "The cessation
of life; the ceasing to exist; defined by physicians as a total
stoppage of the circulation of the blood; and a cessation of the
animal and vital functions consequent thereon, such as respiration,
pulsation, etc.". These indications, however, are unsatisfactory
for the sophisticated medical techniques involved in organ
transplants or in determining if a medical procedure should be
continued. A heart which has stopped may be revived and may beat
again. Similarly, breath, although it has ceased, may also be
revived. A variety of medical groups have expressed dissatisfaction
with existing criteria of death, emphasizing that the critical
question is whether or not death of the brain, i.e., cerebral
death, has occurred.
It is the objective of the present invention to provide an
instrument which accurately, definitely, reliably, continuously and
quickly determines the presence or absence of life. In one
embodiment the instrument is portable and so may be utilized by a
medical aide in the field or used in an ambulance, and is
relatively low in cost.
It is a further objective of the present invention that the
instrument give an objective and recorded output which would be
legally and medically acceptable evidence of the presence or
absence of life over a period of time.
In accordance with the present invention, electronic medical
instruments are provided. One instrument is hand-carried, to be
used in the field, and the other is fixed, to be used in hospitals.
These instruments each include two input devices, an
electrocardiographic amplifier (EKG) and an electroencephalographic
amplifier (EEG), a multi-sensory stimulator and a special purpose
computer. Belts strapped around the chest of the patient, or on his
wrist and ankles, carry electrodes which monitor the electrical
signals generated by the heart. These electrodes are connected to
the EKG amplifier. A plurality of electrodes attached to different
places on the patient's scalp monitor the activity of visual (V),
auditory (A) and somatic (S) receiving areas of the brain, and are
sequentially connected to the EEG amplifier. The output of the
amplifier is connected to the special purpose computer and/or to a
recording device. In the embodiment used in hospitals, by means of
a clock and cycle control device, and a data scanning device, an
output is provided, in timed sequence, of the EKG, the EEG, and the
results of computer analysis of the sensory evoked response in the
EEG, each of the different brain areas being monitored. Each of
these outputs is provided for a determined adjustable time, and
this sequence of outputs is constantly repeated and may be
changed.
The clock and cycle control and the data scanning devices are
connected to the stimulators, the special purpose computer and to a
power amplifier which drives a recording device. Thus, as the data
scanning device sequentially scans the available inputs and the
cycle control switches the stimulator outputs, a record will be
provided which will provide a sample of the EKG for a brief period
("raw" EKG), followed by a sample of the EEG from the visual area
("raw" visual EEG), then the average visual evoked potential from
the visual area (visual AEP), then the EEG from the auditory area
("raw" auditory EEG), then the auditory AEP, then the EEG from the
somatic area ("raw" somatic EEG), then the somatosensory AEP, and
then the cycle would resume with the EKG again. As each sample
period began, the clock time would be printed on the permanent
record.
The clock and cycle control device controls a number of stimulators
whose outputs are directed to the patient. These stimulators are
preferably a visual stimulator, an audio stimulator, and a shock
stimulator. Because sensory-sensory interaction facilitates the
electrical response of the brain to sensory stimuli, these
stimulators will usually be operated so as to deliver a flash of
light, a loud clock and a mild electrical shock to the arm and leg
of the patient. If desired, the stimulators can be operated
sequentially and synchronized with the scanning device so that a
flash of light will occur while the visual EEG is recorded, a click
will occur while the auditory EEG is recorded, electric shock to
arm and leg will occur while the somatic EEG is recorded. A variety
of repetition rates might be used, but present knowledge suggests 8
cycles per second as the optimal stimulus repetition rate. In
certain situations it will be desirable to examine the later
components of the evoked response, for example, so-called component
P.sub.3, and a slower repetition rate will be desirable, e.g., 3-4
per second. Each stimulator output will be accompanied by a trigger
pulse.
The trigger pulse will be recorded by a marker pen on the permanent
record. The output of the data scanning device will go to a pen
recorder and it will also go to a special purpose average response
computer (ARC), which may include either a digital or analog memory
device. The analysis epoch of the average response computer is
preferably 125 or 250 milliseconds, and will be triggered by the
trigger pulse from the stimulator. If the ARC is digital, the
analog output of the data scanning device will be converted to
digital form and then stored in a digital memory so that the
voltage values of the EEG response to the signal in successive
intervals of time are stored in successive digital registers. With
each repetition of the signal to the patient, the digital values of
corresponding segments of the EEG response will be accumulated in
the appropriate registers of the memory. Alternatively, the data
scanning device may be connected to a current source and to a
capacitance memory-integrator which will constitute an analog
average response computer. In this fashion, the average evoked
response of the brain to the sensory stimulus will be computed. The
average EEG will also be computed. Once in each cycle, the
resistance of each of the testing electrodes is tested by an
appropriate circuit. If the resistance exceeds permissible limits,
an alarm signal will be activated and a mark will be made on the
permanent record to invalidate it.
The portable, i.e., hand-carried, version is an instrument about
the size of a one-quarter inch electric drill. It has a
rechargeable internal battery power source and a body portion
containing the EEG amplifier, the EKG amplifier, an electrode
impedance checking circuit, a stimulator, a "one-word" average
response computer and a visual display. Cables lead from the body
portion and terminate in various needle electrodes and various
transducers (microphone, loudspeaker, light source). The electrodes
and transducers are arranged in clamping devices which rapidly fit
on the patient. The visual display gives simple "go - no go"
indications of the life functions of heartbeat and brain activity,
preferably in the form of red and green lamps.
Other objectives of the present invention will be apparent from the
detailed description which follows, presenting the inventors' best
mode of carrying out the invention. The detailed description which
follows should be taken in conjunction with the accompanying
drawings, in which:
FIG. 1 is a block schematic diagram of the first embodiment of the
hospital instrument of the present invention;
FIG. 2 is a block schematic diagram of the second embodiment of the
hospital instrument of the present invention;
FIG. 3 is an illustration of the graph produced by the single-pen
graphic recorder of the instrument of FIG. 1;
FIG. 4 is an illustration of the graph produced by the three-pen
graphic recorder of the instrument of FIG. 2;
FIG. 5 is a perspective view of the portable hand-carried
instrument of the present invention;
FIG. 6 is a top plan view of the visual display of the instrument
of FIG. 5;
FIG. 7 is a block diagram of one portion of the circuit of the
instrument of FIG. 5;
FIG. 8 is a block diagram of the other portion of the circuit of
the instrument of FIG. 5;
FIG. 9 is a block diagram of the one-word average response computer
of the instrument of FIG. 5; and
FIGS. 10A and 10B are diagrams of the electrical wave shapes within
the average response computer of FIG. 8.
I. THE DEFINITION OF DEATH
The definition of death may be critical in certain organ
transplants, such as heart transplants.
Successful transplantation may depend on removal of the organ as
soon as possible after death. If the doctor delays removal of the
heart, there is a risk that it will be so damaged and may be
unusable for the transplant. The removal of the heart precludes any
revival of the donor's life. The doctor runs the risk of civil
liability and criminal sanctions if it is later held that a patient
was not legally dead at the time the organ was removed.
Law and medical science have traditionally accepted the classical
definition of death as being a total stoppage of the circulation of
the blood and a cessation of the animal and vital functions
consequent thereon, such as respiration and pulsation. But
sometimes physicians may revive the heart after it has stopped
beating, which should move the time of death to when the cessation
of the heartbeat is irreversible. Marshall Houts, in his
authoritative work, Death, at sec. 1.03 (4) 1967, has provided the
following legal definition of death:
"Death is the final and irreversible cessation of perceptible
heartbeat and respiration. Conversely, as long as any heart beat or
respiration can be perceived, whether with or without mechanical or
electrical aid, and regardless of how the heart beat and
respiration were maintained, death has not occurred."
This definition of death takes into consideration the recent
medical advances of heart resuscitation. But the underlying
standard of determining death is the cessation of heartbeat and
respiration.
Many physicians now doubt that the traditional definition of death
is adequate. They propose that cessation of brainwave activity is
the most reliable index of death, for example, see Hamlin, Life or
Death by EEG, 190 J.A.M.A. 1964. Their position is that death
occurs when the electrical brain activity, which is measurable on
an electroencephalograph (EEG), ceases.
The presence of brain activity, when the only activity is denoted
by a flat brain wave, is not, however, a reliable indication of
life. Note that the definition of a "flat brain wave" is ambiguous.
At sufficient gain, amplifier noise can always be observed. How is
amplifier noise to be discriminated from brain activity? In recent
years, neurophysiologists have learned to use average response
computation to enhance the signal-to-noise ratio of the electrical
activity of the brain. A strong stimulus is delivered to the
sensory receptors of the organism and the response of the brain is
examined for transient activity which is phase-locked to the time
of stimulation. Since noise will not be phase-locked, averaging the
activity of the brain after a series of stimuli provides a powerful
technique for enhancement of signal-related potentials in records
derived from the brain. Since particular sensory systems may be
damaged in a given patient, preferably one should test three of the
major sensory systems. Presence of a non-zero sensory evoked
response constitutes definitive proof of life.
II. THE DIGITAL INSTRUMENT
The inventors' digital instrument to determine the presence, or
absence, of life is shown in FIG. 1. In the instrument of FIG. 1,
an electroencephalograph (EEG) 10 has electrodes (probes) 11, 12
and 13 which are connected to the head of the patient under test.
For example, the electrode may be placed on the outside of the
patient's head clamped to the skin, or alternatively may be
implanted under the skin. A reference electrode R is connected to
the ear lobe. All EEG potentials are recorded relative to the
reference electrode. The EEG is a device which is able to pick-up
the faint electrical activity of the brain and amplify it
sufficiently so that it is presented in a useable form as a
continuous analog electrical signal. The output of the EEG 10 is
connected to a first data scan device 14 through three connecting
channels 17, 15 and 16. The number of channels corresponds to the
number of electrodes and may be more or less than three. The data
scan device 14 samples the analog output of each of the EEG
electrodes, for example, in sequence. The output of the data scan
device 14, on line 18, is connected to an amplifier 19.
The output of amplifier 19 is divided, with one of its outputs
being connected to the second data scan device 21 by means of line
20. The output of amplifier 19 is communicated, on line 22, to a
third data scan device 60. The third data scan device 60 is
connected to a graphic recorder 23. The graphic recorder 23 has, as
shown, three inputs and one recording pen, although the recorder 23
may have two, three or more, pens or other recording means.
The electrocardiograph device (EKG) 24 has an input line 25 which
is connected to the patient under test. Line 25, for example, may
be a series of belts which are strapped around the chest, wrists
and ankles of the patient, the belts having contact electrodes. The
EKG device picks up the electrical field accompanying the heart's
pumping action and converts it into an analog electrical signal.
The output of EKG device 24, on line 26, is communicated to
amplifier 27. The output of amplifier 27 is split and one of its
outputs 28 is connected to the second data scan device 21. The
output of amplifier 27, on line 29, is communicated to the third
data scan device 60, providing a second source of input information
to the graphic recorder 23. The output of the second data scan
device 21, on line 30, is connected to an analog-to-digital
converter which converts the analog signals into a useable digital
form. The analog-to-digital converter 31 is connected by line 32 to
an average response computer 33. The output of the average response
computer on line 35 is connected to the third data scan device 60
and provides a third source of information to the graphic recorder
23.
The average response computer 33 provides a powerful and reliable
way to extract the response of the brain to sensory stimulation
despite a noisy background. Average evoked responses can readily be
demonstrated by such computations, even when visual inspection
reveals no response to the stimulus in the "raw" ongoing EEG
records. Signal averaging is the method of separating a signal from
noise performed by the average response computer. When the brain
waves of the subject are evoked by some stimulus, for example, a
flashing light, the waves may be undistinguishable from the other
electrical activity of the brain, which is considered as a form of
noise in this context. When viewed on an oscilloscope, a single
evoked response may be so buried in the noise as to be
undistinguishable.
In signal averaging, the approach to the signal-noise problem is to
take a number of the averages of the signal plus its surrounding
noise at a number of intervals in a repeated series. If the
repeated series are each of time T, the series is T.sub.1, T.sub.2
. . . T.sub.N. If one takes sub-intervals of each time period T,
which need not be uniform but usually are, the sub-intervals
(sampling impulses) are t.sub.1, t.sub.2 . . . t.sub.n, etc. One
then has for period T.sub.5, for example, five samples
T.sub.5.sub.-1, T.sub.5.sub.-2, T.sub.5.sub.-3, T.sub.5.sub.-4 and
T.sub.5.sub.-5. At each time period T.sub.1 . . . T.sub.N, the
signal is repeated and the noise is random. For each sample t.sub.1
. . . t.sub.n the signal contribution is the same in each interval
T.sub.1 . . . T.sub.N, but the noise may add or subtract, or be the
same, in a random fashion. Using time periods T.sub.1, T.sub.2,
T.sub.3 and T.sub.4, and sample t.sub.1 in each period for example,
and arbitarily assigning the value 7 to the signal, the results may
look like this:
t.sub.1 = 7 (signal) + 2 (noise) = 9
t.sub.2 = 7 (signal) - 1 (noise) = 6
t.sub.3 = 7 (signal) - 2 (noise) = 5
t.sub.4 = 7 (signal) + 1 (noise) = 8
The sum is 28 and the average is 28/4 = 7, which is the signal
value.
It is necessary for the value, in digital form, to be summed and
averaged. The averaging may take place at the end of the series
samples or after each sample. In either event, the instrument
requires a memory system, for example, a magnetic memory
system.
Average response computation of sensory evoked responses provides
greatly enhanced assurance that brain responsivity to stimuli will
be detected. In this usage, the enhancement of the signal-to-noise
ratio is approximately proportional to .sqroot.n , where N equals
the number of repetitions of the signal. At a repetition rate of 8
cps, 100 signals would be delivered in 121/2 seconds, providing an
average evoked response with about a 10-fold improvement of the
signal-to-noise ratio. For most purposes, this should be
satisfactory.
Although the cycle control will permit cycles of various lengths,
it is preferred that each EEG electrode will be monitored for about
15 seconds per cycle. During that time 121/2 seconds of the EEG
activity of a given brain area during sensory stimulation will be
recorded. The recording device will then switch to the output of
the average response computer and the average evoked response from
the corresponding brain area will be permanently recorded. The
memory of the average response computer will then be erased, so as
to permit computation of the next response to be monitored, as the
cycle control device advances to the next item to be measured.
Clock time will be stamped on the record at the beginning of each
cycle by the time stamp 61.
The clock and cycle control 36 performs various functions in the
instrument. It is used to calibrate, by means of line 37, the
amplifier 19. It is also used to provide a timed sequence control
for the first, second and third data scan devices 14 (line 38), 21
and 60, which are at different rates. In addition, it has an output
line 39 connected to the analog-to-digital converter 31 and
provides the address function on line 40 to the average response
computer. The clock and cycle control 36 has output lines 41, 41'
and 41", which are connected to the stimulators. Preferably these
stimulators are a visual stimulator 42, an audio stimulator 43 and
a shock stimulator 44. The visual stimulator may be in the form of
light which is flashed before the eyes of the patient. The audio
stimulator may be in the form of an audio tone device producing a
sharp sound which is communicated to the patient by means of
earphones or a speaker. The shock stimulator may be an electrical
shock device having output electrodes attached to the arm and leg
of the patient. Since the accuracy of this device will literally be
a matter of life and death, it is essential that the whole system
be tested continuously. Accordingly, a brief calibration pulse will
be generated in synchrony with each stimulus pulse by the clock
control 36. Via dual leads 50-52, the calibration pulse will be
delivered to each electrode at the site of application on the
patient. Through the input electrode leads 11, 12, 13 and 25, this
pulse will come to the amplifiers 27 and 19, pass through the data
scanning device 21, and be stored in the first registers of the
average response computer 33. The size and form of the calibration
pulse in the recorded averaged responses will serve as evidence
that the life detector was functioning properly during the
computation.
Appropriate electronic monitoring of the contents of the relevant
computer registers will be used to activate an alarm signal. For
example, each of the EEG outputs 15, 16 and 17 and EKG output 26
are connected to separate integrating circuits 55, 56, 57 and 58
respectively. The outputs of the integrators 55-58 are connected to
the input of an alarm device 59, for example, a bell. The alarm
device 59, at each of its inputs, is adjusted to become activated
by a fall, at any one of its inputs, below the predetermined level.
The integrators 55, 56 and 57, 58 integrate ongoing visual, audio
and shock response and heart action. In addition, an integrator 60'
is provided, also connected to alarm device 59, to integrate the
averaged response.
The third data scan device 60 is provided with a switch 62 so that
any one or two of the channels may be switched out. For example, to
record only the average response the switch 62 may be set so that
data on line 29 (ongoing EKG) and line 22 (ongoing EEG) will not be
scanned or recorded.
A typical graph produced by the graphic recorder 23 is shown in
FIG. 3. The graphic recorder 23 has a single marking means, such as
a single pen, and three inputs which are switched in predetermined
order and sequence by the third data scan device 60. The "raw" EEG
data from electrodes 11, 12 and 13 are shown by lines 11 1, 12 1
and 13 1, respectively. The raw EKG data is shown by line 23 1. The
data from the average response computer 33 is on line 33 1 and its
origin designated by, for example, 33 1-11 if the data derives from
electrode 11. The time periods, for example, 121/2 seconds and 21/2
seconds, are designated by t.sub.1 . . . t.sub.n.
The timing and switching among the inputs is preferably selectable.
As shown in FIG. 3 the timing is selected so that the sequence is
the raw visual EEG data 11 1 for 121/2 seconds, a calibration mark,
the averaged visual evoked response 33 1-11 for 21/2 seconds, raw
auditory EEG 12 1 for 121/2 seconds, calibration mark, averaged
auditory evoked response 33 1-12 for 21/2 seconds, raw somatic EEG
13 1 for 121/2 seconds, calibration mark, averaged somatic evoked
response 33 1-13 for 21/2 seconds, raw EKG 23 1 for 121/2 seconds,
calibration mark, and averaged EKG 33 1-23 for 21/2 seconds. The
labeling on the FIG. 3 is only for the purpose of clarification as
the actual record, i.e., the paper tape, would consist only of the
time stamp, the record of stimuli delivered, heart beats detected,
calibration pulses, and the raw and averaged data, without
labels.
The instrument of FIG. 1 uses a graphic recorder having a single
marking means, such as a single pen. A data scan device distributes
the inputs 22, 29 and 35 so that they are recorded in sequence.
Alternatively, as shown in the instrument of FIG. 2, the instrument
of the graphic recorded may record the various inputs (EEG, EKG and
computer) on separate channels by using three or more marking pens.
Similarly, the single pen graphic recorder of FIG. 1 may be
utilized in the analog instrument of FIG. 2 by using a data scan
device.
The instrument of FIG. 1 also has indicating devices which do not
make use of the average response computer. An amplitude detector
150, connected to EEG amplifier 19, measures the amplitude of the
peak-to-peak voltage of the brain wave and displays the results on
a meter or employs a warning alarm. For example, the instrument may
be used in an intensive care unit and monitored by a nurse so that
if the peak-to-peak brain wave voltage level drops from the normal
10 microvolts toward the level of 2 microvolts, indicating death,
an alarm will flash, at the 5 microvolt level. A cardiotachometer
151, the circuitry of which is explained subsequently, is connected
to the EKG amplifier 27, as is an audio device 152, such as a
loudspeaker. The cardiotachometer gives the heartbeat rate and the
audio device gives the heartbeat sound.
III. THE ANALOG INSTRUMENT
The inventors' analog instrument is shown in FIG. 2. In FIG. 2 an
electroencephalograph 110 has probes or electrodes 111, 112 and 113
which are attached to the head of the patient under test. The
output of the EEG 110 is connected to a first data scan device 114
through three connecting channels 115, 116 and 117, the number of
channels corresponding to the number of electrodes, which may be
more or less than three. The first data scan device 114 samples the
analog output of each of the EEG electrodes in sequence. The output
of the data scan device 114, on line 118, is connected to an
amplifier 119. One of the outputs of amplifier 119 is connected to
the second data scan device 121 by means of line 120. Amplifier 119
is also connected, by line 122, to the graphic recorder 123. The
graphic recorder 123 has at least three simultaneous input
channels, see FIG. 2.
The electrocardiograph device (EKG) has an input line 125 which is
connected to the patient under test. The output of EKG device 124,
on line 126, is communicated to amplifier 127. One of the outputs
128 of amplifier 127 is connected to the second data scan device
121 and the second output of amplifier 127, on line 129, is
communicated to the graphic recorder 123. The second data scan
device 121, by line 130, is connected to a current source which
provides a current I.sub.o directly proportional to its input
voltage Vi on line 132. The current source 131 is connected, by
line 132, to an analog average response computer 133 having a
capacitor memory. The computer 133, by line 135, is connected to
the graphic recorder 123. A clock and cycle control device 136
calibrates, by line 137, the amplifier 119 and it provides the
sequence control for the first data scan device 114 and the second
data scan device 121. An output line 139 of clock control 136 is
connected to the current source 131 and its output line 140 is
connected to provide the address function to the analog computer
133. The clock and cycle control also has an output line 141 which
is connected to the visual stimulator 142, audio stimulator 143 and
shock stimulator 144, which may be similar to the stimulators of
the digital device.
The analog instrument basically operates in the same general manner
as the digital instrument, the only difference being in the type of
average response computer. In the analog instrument of FIG. 2 the
data storage for producing an average response is by means of a
bank of capacitors and an integrative circuit, which may also use a
capacitor. Other types of analog average response computers or
analog data storage devices may alternatively be utilized.
The operation of the instrument of FIG. 2 is illustrated by FIG. 4.
The three recorded channels produced by graphic recorder 123 are C1
(EKG), C2 (the analog average response computer 133) and C3 (EEG).
The time units, determined by the clock control 136 are t1 through
t6. As shown on channel C3, the data scan 114 shows the output of
the EEG output lines 115, 116 and 117 in sequence, corresponding to
electrodes 111, 112 and 113 respectively. The chart line 111 1-1
indicates that it is the line 1 from electrode 111 in time unit 1.
This comparison provides an indication of trend and will answer
such questions as: Is the brain wave activity decreasing?, Is the
EKG activity increasing?, etc.
Preferably, the analog instrument of FIG. 2 also includes the time
stamp mechanism 61; the calibration pulse checking lines 50-52; and
the integrative circuits and alarm 59 and its connecting lines; all
of which would function and be located as in the device shown in
FIG. 1. These have been omitted from FIG. 2 for the purpose of
simplifying that figure.
As shown in FIG. 5, the portable hand-carried life detecting
medical instrument 200 is about the size of a 1/4-inch electric
drill. It includes a cylindrical body portion 201 and a handle 202
having a switch 203. A first tubular noise shield 204 and a second
tubular noise shield 205 protrude from the body portion 201. The
noise shields 204 and 205 have within them response EEG needle
electrodes 206 and 207 which are spring-loaded and are leads to the
EEG amplifier 230. The unloading mechanism, i.e., the release
mechanism, is operated by the switch 203. When the switch 203 is
depressed, the springs are released and the needle electrodes 206
and 207 spring out and pierce the skin of the head of the patient.
The needle tubes 204 and 205 are separated, so that one of the
needles 206 may be located at the vertex, i.e., center, of the head
and the other needle 207 located at the side of the head.
A first cable 208 protrudes from the body portion 201 and has on
its end a clamping mechanism which fits over the head of the
patient. The clamping mechanism has a loudspeaker 209 which
preferably fits over the ear of the patient, and a flash tube 210
which is positioned over the patient's eyes. Cable 208 also is
connected to a first needle clamp 211 which is adapted to be
strapped to the patient's leg with its needle piercing his skin. A
second needle clamp 212, connected to cable 208, fits over the
patient's wrist, for example, by strapping the clamp to the wrist,
and has its needle piercing his skin. The needle clamps 211 and 212
are adapted to provide mild electrical shocks to the patient, the
flash tube 210 is adapted to provide a light flash to the patient,
and the loudspeaker 209 is adapted to provide click or other noise
to the patient. These various stimulations, namely, the
loudspeaker's click, the flash tube's light, and the electric shock
from the needle clamps, are generated by a stimulator 213 within
the body portion 201.
A second cable 220 and a third cable 221 are also connected to the
body portion 201. The cable 221 leads to an EKG needle electrode
222. The cable 220 leads to a microphone 223 which fits over the
heart of the patient and also to a second EKG needle electrode 224.
Electrodes 222 and 224 are leads of the electrocardiograph
amplifier 225. A spring 226 loads the clamp 227 which slips over
the shoulder of the patient.
As shown in FIG. 7, the stimulator 213 is triggered by the switch
203 to provide stimulations at the predetermined rate of 2 per
second, although other rates may be utilized. The stimulator
receives its timing pulse from alternate outputs of the timer 214,
which is connected by line 215 to provide the timing trigger pulse
and polarity switching pulses to the one-word average response
computer 216, the details of which are described subsequently.
The needles 206 and 207 are the leads to the electroencephalograph
amplifier 230 (EEG). The EEG 230 is connected to a microvolt (MCV)
amplitude detector 231 which measures the average peak-to-peak
voltage over a short time period, for example, one-tenth of a
second. If the average peak-to-peak voltage over that time period
is above 2 mc.v. the green light 232 will light. Conversely, if it
is below 2 mc.v., the red light will become lit. The 2 mc.v. level
has been selected because it is in accordance with the definition
of death as proposed by the International EEG Society. If the red
light is lit and stays lit, and if the other signs of life as
determined by the instrument are also negative, then the patient is
dead. However, even if the other signs of life are negative and the
green light 232 is on, then it cannot be assumed that the patient
is dead.
The EEG amplifier 230 is also connected to the one-word average
response computer 216 and the one-word average response computer
216 is connected to the up-down counter 217. If the output of the
up-down counter 217 is negative, then the red light 218 will be
lit. Conversely, if the output is positive, the green light 219
will be lit.
As shown in FIG. 8, the EKG amplifier 225 is connected to a switch
240, which, if closed, will cause the light 241 to directly flash
at each heartbeat, providing a direct visual indication of the
heartbeat rate. The EKG amplifier 225 is also connected to a peak
detecting circuit 242. The peak detecting circuit is connected to a
switch 243B which is connected to audio amplifier and speaker 244.
The peak detecting circuit 242 is also connected to another switch
243A which is connected to the light 241. Consequently, the light
241 will flash either on the raw heartbeat or, alternatively, at
the heartbeat as shown by the peak detector. The peak detector is a
circuit similar to an automatic volume control circuit which
searches for level given by the peaks of the output (the high
amplitude R pulses). It will produce a standard wave form output
pulse at each high amplitude R peak heartbeat pulse by means of a
standardizing circuit such as a Schmitt trigger. The peak detector
242 is connected to a cardiotachometer 246. The cardiotachometer,
for example, of the type described in U.S. Pat. No. 3,474,778, is a
rate meter (an integrative circuit) which measures the intervals
between heartbeat pulses, i.e., the number of heartbeat pulses in a
time period, for example, 30 seconds. The cardiotachometer 246 is
connected to a visual display meter 247. The meter 247 has an
acceptable zone 248 which is marked in green, a lower and
unacceptable zone 249 and a higher and unacceptable zone 250, both
zones 249 and 250 being marked in red. If the heartbeat rate is too
low, the meter will point within the zone 249; and if the heartbeat
is too high, it will point within the zone 250. The
cardiotachometer is also connected to the lights 251 and 252. If
the heartbeat is acceptable (within the zone 248) then the green
light 251 will be lit; but if the rate is too high or too low (the
meter needle is within the zones 249 or 250) then the red light 252
will be lit.
The one-word average response computer 216 is shown in FIG. 9 as
being connected to the EEG amplifier 230. The absolute value
circuit 261, for example, a bridge rectifier having four diodes,
first produces an absolute value, that is, it produces a voltage
output which is independent of the incoming polarity. The outgoing
polarity, positive or negative, is then controlled by a polarity
reversing circuit 262. The polarity reversing circuit 262 is
connected to an integrator 263. The integrator 263 is connected to
a comparator 266 and the comparator is connected to the up-down
counter 217.
The polarity reversing switch 262 and the integrator 263, as well
as stimulator 213, are connected to timer 214 by lines 215A and
215B. Every pulse from timer 214 reverses the polarity switch 262.
In addition, every other pulse 269 erases and resets the integrator
263, while the next pulse 271 activates the stimulator 213, as
described below and in FIG. 10A.
The computing cycle is initiated by pulse 269 from the timer 214.
Pulse 269 resets the polarity switch 262, erases the integrator 263
and begins the baseline sampling interval 270 lasting 250
milliseconds. Pulse 271 from timer 214 reverses the polarity
switch, delivers a stimulus to the patient via stimulator 213, and
briefly interrupts the computing cycle to protect against artefact,
after which the evoked response sampling interval 272 begins and
lasts for 250 seconds. Thus, the integrated activity accumulated
during the period of evoked response to the stimulus is subtracted
from the integrated baseline activity preceding delivery of the
stimulus.
For example, if the integrator output during interval 270 is a
rising positive waveform, the polarity shift occasioned by pulse
271 will cause a descending negative waveform of equal duration
272. The signals shown in FIG. 10A are taken at the output of the
integrator 263. If there is only noise and no signal, as seen in
baseline interval 280 of FIG. 10B, then the rising level during
baseline interval 270 will go to a certain height 273. On the other
hand, if there is both noise and signal present (as shown by
response interval 280 of FIG. 10B), then the descending voltage
during interval 272 will cross the zero value of the integrator and
go to the level 274.
If the signal plus the noise is greater than the noise, the lower
level 274 of the descending voltage slope will be below a
predetermined voltage level and there will be a plus one count
registered in the up-down counter 217. Conversely, if the signal
plus the noise is less than the noise, then the lower end 274 will
be above the predetermined voltage level and a minus one will be
registered in the up-down counter 217. If only noise is present,
then the run-up and the run-down should average to zero or about
zero. If there is a signal, in addition to the noise, then there
will be a positive average or a negative average, the negative
average corresponding to systematic inhibition of the noise, as in
EEG "arousal." The one-word average response computer,
consequently, only determines the presence, or absence, of a
signal; but does not give any information regarding its wave shape
or amplitude. In this instrument the presence of a signal implies
brain activity in response to stimulation and the presence of brain
activity is an indication of life.
The tester simply depresses the switch and the various tests will
have a duration which is automatically determined. The level of
plus or minus counts over the time period registered in the up-down
counter are compared to a number which is statistically determined.
For example, the critical count level and the test duration may be
adjusted so that there is a 0.001 or 0.0001 chance that the test
would yield a negative result even though the person, by a more
sophisticated technique, might be shown to have brain activity.
The visual display, at the rear of the body portion, is shown in
FIG. 6. It includes lights 275, 276 and 277 which are lit when the
impedance levels at the stimulator needle, EKG electrodes and EEG
electrodes, respectively, are above a predetermined level. If one,
or more, of these lights are lit the leads must be resecured to the
patient. The power switch 278 is used as a safety device so that
accidental operation of the trigger will not start the test and the
pilot light 279 indicates that the power is on. The heart (EKG)
test results are shown by the heartbeat light 241 and the
cardiotachometer lights 251,252 and the meter 250. The brain
activity (EEG) test results are shown by the level (2 microvolts)
lights 232 and 233 and the response (up-down counter) lights 218
and 219.
In summary, the electronic medical instrument of the present
invention will do the following:
Using self-contained circuitry, it will generate visual, auditory,
and somatic stimuli which will be delivered to a patient in a
predetermined scheduled way. It will obtain an electrocardiogram
(EKG) and a series of electroencephalograms (EEG) from the visual,
auditory, and somatic areas of the brain. Resistance measurements
and calibration pulses will automatically validate the accuracy of
these data. A built-in average response computer analyzes these
data and provides an estimate of the average EKG wave shape and of
the average evoked response obtained from each of the monitored
areas of the brain. In the hospital version of the instrument, a
permanent record of these data will be provided. For example, the
record may include, on a cycle repeated once a minute, (1) a
121/2second record of ongoing EKG; (2) the average EKG wave shape;
(3) a 121/2 second record of EEG from the visual area; (4) the
average visual evoked response; (5) a 121/2 second record of EEG
from the auditory area; (6) the average auditory evoked response;
(7) a 121/2 second record of EEG from the somatic area; (8) the
average somatic evoked response; and (9) the clock time of each of
the foregoing items.
In the use of the portable instrument, the person who wishes to
conduct the test, for example, an army medical corpsman on a
battlefield or ambulance personnel at the scene of an accident, or
a fireman at a fire, places the portable instrument near the person
to be tested. He places (1) the leg and arm clamps on the leg and
arm, (2) the headband on the person's head, with its lamp and
microphone, (3) the EEG needle electrodes next to the person's
scalp. He then pulls the trigger switch so that the EEG needles are
released and pierce the skin and the instrument starts to operate.
He then watches the cardiotachometer meter and the various green
and red lights. If all the lights are red and the meter is in an
"unacceptable" zone, the person is dead. If any of the lights are
green or the meter in the "acceptable" zone, he may still be
alive.
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