U.S. patent number 3,618,592 [Application Number 04/848,930] was granted by the patent office on 1971-11-09 for diagnostic patient monitor.
Invention is credited to John Stewart Simpson Stewart.
United States Patent |
3,618,592 |
Stewart |
November 9, 1971 |
DIAGNOSTIC PATIENT MONITOR
Abstract
A diagnostic patient monitor is provided which monitors the
condition of a patient by means of a sensor system to provide
output signals, not less than six in number, indicative of normal,
above normal or below normal sensed conditions from at least two
sensors. The signals are used to directly indicate each condition
and are combined so that specific combinations of abnormal signals
provide an indication of the condition of the patient resulting in
the abnormal signals. Two abnormal signals occurring simultaneously
result in the activation of an alarm.
Inventors: |
Stewart; John Stewart Simpson
(Lancashire, EN) |
Family
ID: |
10402217 |
Appl.
No.: |
04/848,930 |
Filed: |
August 11, 1969 |
Foreign Application Priority Data
|
|
|
|
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Aug 9, 1968 [GB] |
|
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38,245/68 |
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Current U.S.
Class: |
600/484;
607/9 |
Current CPC
Class: |
A61B
5/412 (20130101); A61B 5/00 (20130101); A61B
5/0205 (20130101); A61B 5/276 (20210101) |
Current International
Class: |
A61B
5/00 (20060101); A61B 5/0205 (20060101); A61B
5/0408 (20060101); A61B 5/0424 (20060101); A61b
005/02 () |
Field of
Search: |
;128/2.06,2.1,2.5T,2.5P,2.5S,2 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Other References
Body Function Recorder, Honeywell Co. Sales Pamphlet, (12-8-61)
(copy in 128/2.1 R) .
The Lancet, Oct. 13, 1962, pp. 759-60, (copy in 128/2.1 R) .
Popular Electronics, Nov. 1964, pp. 45-48, 108-111, (copy in
128/2.1 R) .
Surgery, Dec. 1968, pp. 1057-1070 (copy in 128/2.1 R).
|
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Howell; Kyle L.
Claims
What is claimed is:
1. An apparatus for monitoring the condition of a patient and
making a diagnosis which includes at least three sensing means for
continuously sensing different physical conditions of said patient,
each such sensing means operating in response to sensed deviation
from a normal condition to provide one of two abnormal signals, one
such abnormal signal being indicative of an above normal condition
and the remaining abnormal signal being indicative of a below
normal condition, a plurality of condition indicating means, each
such indicating means being operative to indicate a physical
condition resulting in a specific combination of said abnormal
signals, diagnostic logic circuit means connected to receive
abnormal signals from said sensing means, said diagnostic logic
circuit means operating upon the simultaneous occurrence of a
combination of abnormal signals from at least two of said sensing
means to provide an activating signal to a specific condition
indicating means for indicating the physical condition giving rise
to such combination of abnormal signals.
2. The apparatus of claim 1 which includes alarm logic means
connected to receive said abnormal signals, said alarm logic means
operating upon receipt of at least two simultaneously occurring
abnormal signals to provide an output alarm signal.
3. The apparatus of claim 1 wherein said sensing means operates to
provide a normal signal in response to a sensed normal condition,
and sensor monitoring means connected to each such sensing means,
said sensor monitoring means operating to provide a monitor output
signal in the absence of a normal or abnormal signal from an
associated sensing means, monitor logic means connected to receive
monitor output signals from said sensor monitoring means, said
monitor logic means operating to provide a monitor alarm signal in
response to the simultaneous occurrence of two monitor output
signals.
4. The apparatus of claim 3 which includes warning logic means
connected to receive said abnormal signals from said sensing means
and said monitor output signals from said sensor monitoring means,
said warning logic means operating to provide a warning alarm
signal upon the simultaneous occurrence of an abnormal signal and
monitor output signal.
5. The apparatus of claim 4 which includes alarm means connected to
operate upon receipt thereby of either said monitor alarm signal or
said warning alarm signal.
6. The apparatus of claim 5 which includes alarm logic means
connected to receive said abnormal signals, said alarm logic means
operating upon receipt of at least two simultaneously occurring
abnormal signals to provide an output alarm signal to operate said
alarm means.
7. The apparatus of claim 4 wherein said warning logic means
operates to provide a warning signal upon the occurrence of either
an abnormal signal or a monitor output signal and warning indicator
means connected to provide a warning indication upon receipt
thereby of said warning signal.
8. The apparatus of claim 1 wherein said sensing means are
individually responsive to heart action, circulation and
respiration.
9. The apparatus of claim 3 which includes a normal indicator means
for each of said sensing means connected to provide an indication
upon receipt thereby of a normal signal from an associated sensing
means, an above normal indicator means for each of said sensing
means connected to provide an indication upon receipt thereby of an
above normal signal from an associated sensing means and a below
normal indicating means for each of said sensing means connected to
provide an indication upon receipt thereby of a below normal signal
from an associated sensing means.
Description
This invention relates to apparatus for supervising the condition
of a patient.
In existing apparatus a measurement is derived from a patient by
way of a sensor. This measurement or another derived from it and
called a parameter is obtained continuously. The clinician sets the
upper and lower limits of the range which is acceptable as normal
in the patient. Departures from this range are denoted by alarm
signals. Several parameters may be similarly and simultaneously
derived with their respective alarm signals. The multiplicity of
alarms, many of which are trivial or false, distresses the patient
and destroys the confidence of the nursing and medical staff in the
accuracy and reliability of the apparatus.
The improved apparatus described herein processes the signals from
at least three parameters. Preferably the three parameters are
heart action, blood circulation and respiration gas exchange. A
diagnosis is made of the condition and of its urgency of need for
treatment. The diagnosis is in respect of clinical condition,
sensor performances and power reserves. This information is
communicated in a simple unambiquous way by visual displays and
auditory signals. All the important clinical emergencies which are
associated with acute circulatory failure: cardiac arrest, hypoxia
and shock, are diagnosed and indicated with accuracy and
reliability. The features of which each diagnosis is compounded are
also indicated.
Many of the alarm systems proposed in the past have suffered from
the disadvantage of providing frequent false alarms. Monitoring
systems are more reliable if multiple parameters are processed and
alarms are restricted to simultaneous transgression of limits in
respect of two parameters or if sensors are duplicated. This is
because the weakest link in the system is the patient sensor
interface. It is the purpose of the invention to provide an
improved monitoring system which represents an optimal solution of
the problem from the point of view of comprehensiveness and
economy.
According to the invention there is provided an apparatus for
monitoring the condition of a patient including at least three
input terminals to which can be applied signals indicating the
condition of a patient with respect to at least three parameters
respectively, a circuit arrangement for deriving signals denotive
of the departure of the applied signals from inside a predetermined
range and means for providing indications when predetermined
combinations of derived signals occur.
Features and advantages of the invention will appear from the
following description taken in conjunction with the accompanying
drawings in which:
FIG. 1 is a block diagram showing an embodiment of the
invention;
FIG. 2 illustrates the control panels of an apparatus according to
the invention; and
FIG. 3 is a logic diagram illustrating the operation of the
apparatus shown in FIG. 2.
Acute circulatory failure may be due to cardiac insufficiency,
peripheral vasodilatation or decreased circulating blood volume,
commonly due to cardiac arrest, hypoxia and shock. The three
preferred parameters, derived in the example from sensors S1, S2,
S3 relate respectively to heart action, rate, force, volume or
efficiency; to blood circulation, pressure, flow, velocity or
efficiency and to respiration, in lungs or tissues, rate, force,
volume or efficiency. Thus a type S1 sensor measures, for example,
heart rate, stroke volume or ventricular force, etc. Heart rate,
for example, may be derived from electrocardiogram,
phonocardiogram, peripheral pulses or from the wave form of blood
pressure, blood flow, blood velocity, etc. A type S2 sensor
measures, for example, blood pressure, blood flow, blood velocity
or circulation time. These may be derived from finger pulse or
intra-arterial catheter using strain gauge, pressure transducer,
electromagnetic flow meter or ultrasonic velocity meter, etc. A
type S3 sensor measures, for example, respiration rate, oxygen
tension, carbon dioxide partial pressure or acidosis. Respiration
rate may be derived from respiration sounds, impedance
plethysmography, strain gauge, nasal temperature, etc. Gas levels
in blood or tissues may be derived from oximeter, electrode,
electroencephalogram, etc.
The responses of the parameters can be in various forms, but it is
convenient if the responses are translated to digital or analogue
equivalents in a common quantity. Electrical variations of voltage
or current are especially suitable but other quantities, such as
hydraulic or pneumatic pressure, mechanical force or displacement
can be used also but in general electrical equivalents can be
obtained easily, if not produced directly by the appropriate sensor
and once obtained can be readily processed. In the arrangement
described more fully herein the sensors S1, S2 and S3 derive
respectively the electrocardiogram heat rate, the blood pressure
and the oximeter oxygen tension. Thus the input of the analyzer, or
data processing unit, consists of electrical equivalents of heart
action, blood circulation and respiration.
Reliability is obtained by a process of comparison and logic
analysis performed in the analyzer. The sensor output is examined
before or after derivation of the desired parameter to determine if
it is characteristic or meaningful. Detachment of a measuring
device may be detected in this way. Each parameter is examined in
respect of nature, duration and rapidity of response in addition to
simple departure from range. Some false signals, for example those
due to motion artifact or some true signals of trivial importance,
for example tachycardia due to physical exertion, are thus
prevented from giving alarms. The same parameters, derived by
duplication of sensors or otherwise, from different sources are
examined. Disparity indicates false signals due, for example, to
artifact or detachment of a sensor.
Accuracy of diagnosis is achieved by a process of logic analysis
performed in the analyzer or data processing unit. Data presented
to the analyzer can be expressed quantitatively as high (+), normal
(0), or low (-). If a quantitative estimate is made successively
for heart rate, blood pressure and oximetry, a simple three symbol
code expresses the situation. Thus the normal is (0 0 0) and a
patient with oligaemic shock who has tachycardia, hypotension and
as yet normal oxygen tension, would be represented as (+ - 0). The
clinician would be alarmed by (- - -) or (- - 0) which would be
found in ventricular fibrillation and would wish to know about
warning signs such as tachycardia (+ 0 0), hypertension (0 + 0) and
cyanosis(0 0 +). He would also wish to know about (- 0 0) which
would indicate that the electrocardiogram has been
disconnected.
The permutation of three settings (+ 0 -) with three signals, heart
rate, blood pressure, oximetry, are 3.sup.3 or 27. The clinical
meaning which is assigned to each of the permutations is given in
the following table. ##SPC1##
It is a main purpose of the machine to communicate with those
tending the patient if the condition of the patient and the machine
is not entirely satisfactory. The output indicates firstly the
abnormal state, clinical or machine, secondly the component
clinical signs or machine faults which make up the abnormal state,
and thirdly the degree of urgency of the indicated condition. The
output may be visual with continuous or flashing lights or
illuminated panels indicating the condition or it may be auditory
with continuous or intermittent warning or alarm sounds. Provision
can be made for connection to a pacemaker in which case a panel
light PACER can be illuminated when this is in action. A light
comes on when the power is switched on and there is also a series
of on/off switches.
In practice, one central unit can be used with numerous patients.
Each patient is then provided with appropriate sensors and the
sensors of each patient in turn can be connected to the data
processing part of the apparatus.
Additional optional equipment includes the pacemaker already
mentioned, an oscilloscope for display of the electrocardiogram,
blood pressure or oximeter reading and a recorder for producing
permanent records. It should be noted that it is not necessary to
provide digital display, dials or meters showing the numerical
values of the measurements. If these are within the permitted
limits no record is necessary; if not, a warning is given and the
absence of a dial encourages the nurse to look at the patient,
where her attention should be directed, not at the machine. In the
event of an arrest display and recording equipment might be helpful
but such equipment is portable and can be brought: it need not be
incorporated for it is not an essential part of every monitor.
The form of one embodiment of the apparatus is shown
diagrammatically in FIG. 1. Sensors S1, S2 and S3 are applied to a
patient; for reasons mentioned above, the sensors may be duplicated
or supplemented. Similar sensors are applied to other patients, the
responses being derived over leads P2, etc. The sensor outputs are
selected in sequence by selector switches SS1, SS2, SS3 and applied
to comparator stages C1, C2, C3, and the outputs compared against
settable standard responses from sources R1, R2, R3. If desired,
the reference responses may be set for the sensor for each patient,
as by reference switches RS1, RS2, RS3, moving with the selector
switches.
The derived error or deviation signals are fed to the data
processing unit DPU and caused, on the logic of the Table, to
operate visual and auditory warning and alarm indicators W, A
respectively. The pacemaker PS sensor controls, through the
processing unit DPU, the pacemaker indicator P.
In the embodiment described here (FIG. 2) the display consists of
illuminated diagnosis panels 61 which give the diagnosis or machine
fault and an analysis panel 60 showing the sensor state in a panel
of nine indicator lights which give the component features of
clinical and sensor conditions. In the diagnosis panel 61 ABNORMAL
is illuminated if there is any clinical or sensor abnormality.
Diagnosis of ARREST, ANOXIA and SHOCK are illuminated when
appropriate according to the logic of the Table. The panels SENSOR
and POWER are illuminated in the event of sensor fault or power
failure.
The analysis panel 60 indicates the state of each sensor of type
S1, S2 and S3, whether "normal," "high" or "low" due to clinical
condition as in the table or sensor fault. Adjacent to each "high"
or "low" indicator light of the analysis panel 60 may be given if
desired the appropriate clinical sign or feature, for example,
tachycardia, bradycardia, hypertension, hypotension, cyanosis. As
noted later, this is dependent to some extent on the type of sensor
used.
The type of auditory output, WARNING or ALARM, is also shown in the
table. Controls for the auditory warning 66 permit regulation in
respect of volume and of time interval between visual display and
auditory warning. Usually the person tending the patient will note
an abnormality (one parameter abnormal; see Table) and correct this
early warning before the auditory warning sounds and without
disturbing the patient. It is noted (see table) that early shock is
a warning condition but severe shock is an alarm condition.
Level set controls are provided for each sensor. For the type S1
sensor, here the electrocardiogram, the central control 57 is used
to set the machine "normal" to the patient's heart rate. The
adjacent maximum 59 and minimum 58 controls set the upper and lower
permitted limits. Similar sets of controls for type S2 and type S3
sensors are provided.
The type S1 sensor input is by a socket 51 and adjacent is an
output socket 52 for display, if desired. Similar sockets are
provided for the type S2 sensor 53, 54 and the type S3 sensor 55,
56.
Also shown are a "machine on" indicator light 63, auditory warning
volume and time delay control 66, switches to reset alarm 64 and
display 65 and an on/off switch 67. The alarm reset switch 64 is
used to suppress temporarily the auditory alarm when setting up the
machine or attending to a patient after an alarm. It returns
automatically to the "alert" position after an interval. The
display caused by any abnormal condition is held until reset to
"normal" by the reset display button 65.
The logic circuit of the apparatus is shown in greater detail in
FIG. 3. The sensors are indicated as S1, S2 and S3 at the left-hand
side of the drawing, and as stated above they produce signals
generally in analogue form related to heart action, circulation and
respiration respectively. In the embodiment described herein they
are an E.C.G., blood pressure meter and oximeter respectively. The
signal from the E.C.G. is applied to the apparatus at the input
terminal and transformed by a circuit indicated by the block 1 to
an analogue signal the value of which depends on pulse rate, and
applied to a discriminator 2 which has three outputs. Signals
appear on an appropriate output conductor dependent on whether the
rate is normal, too high or too low respectively, these conductors
being designated 0, + and - respectively as shown.
In a similar manner signals from a blood pressure meter and
oximeter are applied to circuits 3 and 4 respectively which, like
the circuit 2, each have three outputs, a signal appearing on the
appropriate one of the three in dependence on whether the value is
normal, too high or too low.
Associated with each sensor S1, S2 and S3 there is provided a
circuit, 30, 31 and 32 respectively, which provides an output
signal when no meaningful signal is being received from the
appropriate sensor. This can happen for example if the sensor goes
faulty or drops off the patient. These output lines are designated
NIL.
The three NIL conductors are connected to the OR gate 5 which is
connected to the SENSOR indicator so that the SENSOR indicator and
WARNING are operated if any of the sensors fail. Similarly, the NIL
conductors are connected in pairs to the three OR gates 6, 7 and 8
which are in turn connected to a 3-gate (three input AND gate) 9.
The output from the 3-gate 9 is connected to an OR gate 10 the
output of which is connected to the ALARM indicator so that the
ALARM is operated whenever two or more of the sensors fail to
operate.
The - outputs from S2 and S3 are connected to an OR gate 11 the
output of which is connected to a 2 -gate (two input AND gate) 12
the other input of which is a connection from the + output of S1.
The output from gate 12 is connected to said OR gate 10 and to an
OR gate 15 the output of which is connected to the SHOCK indicator.
Thus, both the ALARM and SHOCK indications are given if either low
oxygen or low blood pressure are associated with increased rate of
heart beat. Similarly, the + outputs from S2 and S3 and the +
output from S1 are connected to OR gate 13 and 2-gate (two input
AND gate) 14 to provide an indication when either increased oxygen
or increased blood pressure are associated with increased rate of
heart beat. The output from 2-gate 14 is applied to said OR gate 15
so that in these conditions the SHOCK indication is given.
The - outputs from S2 and S1 are connected to a 2-gate (two input
AND gate) 16 the output of which is connected to said OR gate 10.
The output of said 2-gate 16 is also connected to the ARREST
indicator. Thus, both ALARM and ARREST are indicated when low blood
pressure is associated with reduced rate of heart beat.
The + and - lines from S3 are connected to an OR gate 17 the output
of which is connected to a 2-gate (two input AND gate) 18 the other
input of which is the - output from S2. Thus, gate 18 provides an
output when reduced blood pressure is associated with either
increased or reduced oxygen content of the blood. An oximeter is
peculiar in that a high reading may be due to disconnection of the
sensor from the patient. In such a situation an abnormal condition
must be assumed. Alternatively, if the original setting is made
during cyanosis, a relatively high reading represents return to
normality. With other type S3 sensors a high reading is abnormal if
the original setting was normal. The output of 18 is connected to
said gate 10 to produce an ALARM indication in these circumstances
and also to an indicator ANOXIA.
The NIL conductors from each of the sensors are connected to
reversing stages 19, 21 and 23 respectively so as to provide inputs
to respective 2-gates (two input AND gates) 20, 22 and 24 when
signals are being obtained from the sensors S1, S2 and S3. The
other inputs of the gates 20, 22 and 24 are the respective -
outputs from said sensors S1, S2 and S3. The outputs from said
2-gates 20, 22 and 24 are applied as inputs to an OR gate 25, to
which are also applied signals from the respective + lines from the
three sensors. The output from OR gate 25 is applied to a gate 26
the other input of which is a signal obtained from the sensor line.
The output from said gate 26 is applied to said OR gate 10 so that
an ALARM is indicated when there is a failure of one sensor in
conjunction with an ABNORMAL indication from one or more of the
remaining sensors. The purpose of circuits 19, 20 in the S1 complex
is to inhibit the - output in the event of a sensor failure which
would otherwise give an alarm through circuit 5 and 25. The
circuits 21, 22 and 23, 24 perform the same functions in the S2 and
S3 complexes.
An OR gate 27 has as its inputs connections from each of the + and
- outputs from the three sensors so that there is an output
whenever any of the sensors indicate an ABNORMAL condition. This is
used to indicate ABNORMAL and also applied to an OR gate 28 the
other input of which is a signal from the SENSOR indication. If
either is present, a WARNING is indicated.
The battery is connected via a circuit 29 which provides an output
when no signal is present to an indicator which indicates when
there is a power failure. The battery is connected directly to
another indicator which indicates when the machine is on.
The +, 0 and - outputs from the three sensors are connected to the
control panel to indicate in the section designated 60 the nature
of the outputs from each of the three sensors. It will be seen also
that in the section of the front panel designated 61 are the
indications for the conditions ABNORMAL, ANOXIA, ARREST, SHOCK,
SENSORS and POWER the operation of which has been described in
connection with FIG. 3. An output from the heart beat sensor S1 is
applied to the panel to provide a flashing indication of the heart
beats of the patient as shown at 62.
It will be appreciated that the nature of the condition which gives
rise to a WARNING is dependent to some extent on the nature of the
sensor which is used. For example, an ear oximeter measures color
and diagnoses cyanosis, but a respiration rate monitor diagnoses
high or low rates, that is, tachypnoea or apnoea and so on.
However, providing the three sensors are of the types S1, S2 and S3
as defined above, then the same logic circuits can be used and all
the important ALARM conditions of ANOXIA, ARREST and SHOCK are
correctly diagnosed. Moreover, warning of early shock is given and
also early warning is given if any one parameter is ABNORMAL.
It will be apparent to those skilled in the art that many changes
may be made to the apparatus described above in accordance with the
invention thus, whilst FIG. 3 illustrates a preferred logical
arrangement, it can be modified by, for example the use of NAND/NOR
electronics, fluid logic, reed or other relays and other types of
logic switches.
The analyzer will function correctly with a wide variety of sensors
provided that one parameter for each group S1, S2, S3 is derived
directly or indirectly. It will be apparent to those skilled in the
art that there is a multiplicity of ways for deriving parameters
from a multitude of sensors.
These or other sensors may be used to derive other parameters which
may be used to give additional warnings. For example, venous blood
pressure may be used as an index of shock or transfusion
requirements; body temperature may be used as an index of sepsis or
increased intracranial pressure.
* * * * *