U.S. patent number 3,814,082 [Application Number 05/235,547] was granted by the patent office on 1974-06-04 for patient monitoring systems.
This patent grant is currently assigned to National Research Development Corporation. Invention is credited to David Ernest Meguyer Taylor.
United States Patent |
3,814,082 |
Taylor |
June 4, 1974 |
PATIENT MONITORING SYSTEMS
Abstract
A patient monitoring system is provided in which signals are
obtained from transducers to represent parameters of the patient's
condition and these signals are integrated with a time-loading and
then compared with reference levels to provide digital signals
indicating whether the integrated signals exceed the reference
levels or not. Predetermined combinations of the digital signals
denote patient conditions requiring attention and such combinations
are recognised by logic to generate warning or alarm signals. Any
one transducer can be associated with both relatively short and
long time constant integration with the short and long term
integrated signals being separately compared with respective
references. Furthermore, such short and long term integrated
signals can be differenced and compared with a further reference.
It may also be appropriate to compare the transducer signals
directly with yet further references. All such comparison can
provide digital signals relevant to indicating patient's condition,
and all such comparisons can be made with both high and low level
references.
Inventors: |
Taylor; David Ernest Meguyer
(Edinburgh, SC) |
Assignee: |
National Research Development
Corporation (London, EN)
|
Family
ID: |
9828570 |
Appl.
No.: |
05/235,547 |
Filed: |
March 17, 1972 |
Foreign Application Priority Data
|
|
|
|
|
Mar 18, 1971 [GB] |
|
|
7202/71 |
|
Current U.S.
Class: |
600/483 |
Current CPC
Class: |
A61B
5/7242 (20130101); A61B 5/02 (20130101) |
Current International
Class: |
A61B
5/02 (20060101); A61b 005/02 () |
Field of
Search: |
;128/2.5A,2.5M,2.5P,2.5R,2.5T,2.6A,2.6F,2.6R,2.1B,2.1R |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Kamm; William E.
Attorney, Agent or Firm: Cushman, Darby & Cushman
Claims
I claim:
1. A patient monitoring system comprising:
a plurality of transducers providing analogue transducer signals
representing respectively different parameters of a patient's
condition;
respective integrating means each connected with an associated one
of said transducers to provide analogue time-loaded integrated
signals in response to said transducer signals;
respective reference sources providing first and second reference
level signals;
respective first comparison means connected to each of said
integrating means and the respective one of said reference sources
to provide a first digital signal in response to said integrated
and first reference level signals, indicating the relative levels
of the latter signals;
respective second comparison means connected to each of said
transducers and the respective one of said reference sources to
provide a second digital signal in response to said transducer and
second reference level signals, indicating the relative level of
the latter signals;
logic means connected to each of said comparison means to provide
an indicator signal in response to each of a plurality of
predetermined combinations of said first and second digital
signals; and
a patient hazard indicator connected to said logic means, which
indicator is operable in response to said indicator signal.
2. A system according to claim 1 wherein at least one of said
integrating means comprises first and second integrators having
respectively short and long time constants, each responsive to said
transducer signals to provide respectively short term and long term
integrated signals; and wherein the respective one of said first
comparison means is in two parts, both connected with the
respective one of said reference sources, and respectively
connected with said first and second integrators, to individually
provide said first digital signals.
3. A system according to claim 2 comprising differencing means
connected to said first and second integrators to provide a
difference signal in response to said short and long term
integrated signals; and wherein said first comparison means
comprises a third part connected to said differencing means and the
respective one of said reference source to individually provide, in
response to said difference and second reference level signals,
said first digital signals.
4. A system according to claim 1 wherein at least one of said
reference sources provides fixed value second reference level
signals, and comprises third integrating means connected to the
respective one of said transducers to provide up-dated first
reference level signals in response to said transducer signals.
5. A system according to claim 1 wherein at least one of said
integrating means provides its integrated signal output to
represent the exponentially mapped past function of the respective
transducer signal.
6. A patient monitoring system comprising: at least two transducers
for providing transducer signals representing respectively
different parameters of a patient's condition; respective
integrating means connected with each of said transducers to
provide time-loaded integrated signals in response to said
transducer signals; a plurality of reference sources for providing
individual high reference level signals and individual low
reference level signals for each of said integrated signals;
respective comparison means connected with each of said integrating
means and with said reference sources to compare each of said
integrated signals with associated ones of said reference level
signals and to provide first digital signals indicating whether
said integrated signals are higher or lower than said reference
level signals; a plurality of further reference sources for
providing further individual high reference level signals and
further individual low reference level signals for each of said
transducer signals; respective further comparison means connected
with each of said transducers and with said further reference
sources to compare said transducer signals with associated ones of
said further reference signals and to provide second digital
signals indicating whether said transducer signals are higher or
lower than said further reference level signals; hazard logic means
connected to each of said comparison means and said further
comparison means to provide a warning signal in response to at
least one predetermined combination of said first and second
digital signals, and an alarm signal in response to at least one
other predetermined combination of said first and second digital
signals; fault logic means connected to each of said further
comparison means to provide a fault signal in response to at least
one predetermined combination of said second digital signals, and
respective indicator means connected to said hazard and fault logic
means for operation in response to said alarm and fault
signals.
7. A system according to claim 6 wherein each of said integrating
means comprises both relatively short and long time constant
integrating means connected with the respective one of said
transducers to provide individual integrated signals.
Description
Various systems have been proposed for automatically and
continuously monitoring the condition of a patient, typically in an
intensive care ward, for example, with a view to triggering an
alarm when the patient's condition is such as to require further
attention. However, generally speaking, these proposals have proved
unsatisfactory for one reason or another.
Many of the proposed systems can only monitor instantaneous values
of parameters such as blood pressure, respiration rate, pulse rate,
etc., with an alarm being triggered if the monitoring parameter
passes a predetermined level which is clinically significant. Such
systems are prone to produce a high incidence of false alarms since
the parameters concerned can pass transiently through the relevant
levels without necessarily denoting a specific cause for concern.
The obvious expedient of so setting the relevant levels to reduce
the incidence of false alarms is equally clearly hazardous and
undesirable.
More recent proposals seeking to remedy this situation suggest the
simultaneous monitoring of several parameters and triggering an
alarm in response to predetermined patterns of parameter values.
Again, though, it is proposed that reference be made only to
instantaneous values, the likelihood of false alarms must still
exist as a significant factor.
The present invention distinguishes from the above systems in a
more general sense by taking account of the trend of parameter
values representing a patient's condition. This reflects the fact
that the trends of individual parameters and the trend pattern of a
group of parameters are, traditionally, significant factors
considered by the physician in diagnosis and prognosis. Indeed,
attempts have been made to take account of these factors in a
patient alarm system by use of a digital computer facility.
However, this last approach is clearly very expensive in terms of
equipment, and few hospitals would be able to provide the necessary
on-line facility.
The present invention, on the other hand, seeks to afford a
similarly useful result by way of special-purpose, simplified
equipment which will normally be of hybrid analogue-digital
form.
The invention has been developed following retrospective analysis
of monitored parameter outputs from many patients in an intensive
care ward. Such an analysis shows that the waveform of the commonly
monitored parameters is a compounded series of phasic oscillations
having cycle times ranging from a short term of 3 - 6 seconds for
first order sinusarrhythmia to about 20 minutes for a fourth order
oscillation. Moreover, it is found that the various orders of
oscillation have no regular mathematical relationship with each
other. Accordingly, assessment of such signals can be made by use
of random noise analysis techniques.
More particularly, it is proposed that, since the variation in an
observed parameter signal can be of similar order to clinically
significant variation without necessarily being significant, each
parameter signal should be assessed on the basis of a mean
representation thereof. At the same time, assessment of a trend in
a signal should take account of time so that distant values have a
consistently reduced significance relative to more recent values.
Both of these requirements can be met by providing a time-loaded,
integrated or accumulated representation of each parameter
signal.
In any event, a more general form of the invention provides a
patient monitoring system comprising at least two integrating means
for providing respective time-loaded integrated signals in response
to transducer signals representing respective parameters of a
patient's condition, respective comparison means for comparing each
of said integrated signals with reference level signals to provide
digital signals indicating whether said integrated signals are
higher or lower than the associated reference level signals, and
logic means for operating a warning or alarm indicator in response
to at least one predetermined combination of said digital
signals.
The time factor to each integrating means will be chosen in
relation to the parameter involved and the potentially hazardous
patient condition or conditions against which monitoring is to be
effected. The time factor will normally be relatively long term,
but an individual transducer signal may be subjected to two
integrating functions with differing time factors for use in
relation to different conditions. More particularly, it is useful
to generate both relatively long and short term functions for some
parameters since the sense and magnitude of the difference or
`error` between these is itself a useful indicator of trend. Indeed
a more accurate determination of change and trend can be obtained
by integration of such an error signal, but this is not normally
necessary for practical purposes.
Short term functions and also the instantaneous transducer signals
themselves are, in any case, useful in their own right in order
that potentially acute emergencies, such as cardiac arrest, can be
detected.
Also, it is to be noted that it will normally be appropriate to
compare at least some of the integrated signals with both high and
low reference level signals.
Regarding the form of integrating functions to be used in practical
application of the invention: one function suitable for this
purpose, and used as a basis for initial development of the present
invention, is the exponentially mapped past function, hereinafter
denoted as EMP (Otterman, 1960) defined mathematically as:-
##SPC1##
In this function, a can be regarded as the time factor since it
determines the term during which the significance of the integrated
function f(t) reduces to a low level. For example, the significance
is reduced to 5 percent in a time of 3/a seconds.
For a fuller understanding of the present invention, the same will
now be described by way of example with reference to the
accompanying drawings, in which:-
FIG. 1 schematically illustrates one embodiment of a system
according to the invention,
FIG. 2 illustrates part of the embodiment of FIG. 1 in more
detail,
FIG. 3 similarly illustrates another part of FIG. 1, and
FIGS. 4 to 6 illustrate respective parts of FIG. 3 in yet more
detail.
FIG. 1 schematically illustrates a patient alarm system according
to the invention in which four basic parameters relevant to the
patient's condition are taken into account. These parameters are
mean arterial blood pressure, pulse rate, mean central venous blood
pressure, and temperature, the last-mentioned being in the form of
body core temperature, skin temperature, or the difference between
such temperatures. Electrical signals representing the current
values of these parameters are readily obtained by the use of any
suitable forms of transducers and such transducers are denoted at
1a - 1d in FIG. 1.
The transducer output signals are applied to respective
integrator/comparator arrangements of similar form denoted at 2a -
2d. These arrangements serve to provide various time-loaded,
integrated signals in response to the transducer signals, compare
the integrated signals with appropriate reference signals, and
provide first digital signals indicating whether or not the
integrated signals exceed the corresponding reference signals or
not.
The transducer output signals are also applied to respective
comparators 3a - 3d for direct comparison with further reference
signals and generation of second digital signals having a similar
function to the first digital signals.
All of the first and second digital signals are applied to hazard
indicator logic denoted at 4 which may be of any appropriate
arrangement of AND and OR gates to provide active output signals in
response to predetermined combinations of digital signal inputs.
Such a combination will be chosen to represent a patient's
condition which is hazardous, or at least potentially so. If a
given combination of digital signals represents a potentially
hazardous condition then the revelant active output is applied to a
warning indicator 5, while if the condition is currently hazardous
the active output is applied to an alarm 6.
A reset facility 7 is provided for the warning indicator and alarm,
and this facility must be activated through a manual switch to
signify acknowledgement of the patient's condition after a warning
or alarm is generated, whereafter the facility automatically resets
the warning indicator and alarm in the absence of an active output
from the hazard logic, that is to say, when the patient returns to
a non-hazardous condition.
The second digital signals are additionally applied to fault
indicator logic denoted at 8 which, as the terminology suggests,
indicates when a fault has occurred. This logic is responsive to
non-integrated transducer signals since such signals will show up
faults most rapidly and the most common fault will be in transducer
operation. The logic 8 comprises an arrangement of OR gates of any
suitable form to produce an active output in the event of a fault
and so energise a fault indicator 9. Any such active output is also
applied to all of the integrator/comparators to hold the integrated
signals at their current values when the fault occurs and until the
fault is cleared.
The comparators 3a - 3d are of similar form and it is convenient to
describe only one of these in more detail with reference to FIG. 2.
FIG. 2 in fact serves to show that the relevant transducer signal
is not compared with a single reference signal but is compared in a
first or high comparator 20 with a fixed high level electrical
reference signal from a source 21, and in a second or low
comparator 22 with a low level electrical reference signal from a
source 23. The high and low comparators can be of any appropriate
form to compare the relevant parameter and reference signals,
suitably in analogue form, and generate the second digital signals
denoting whether the parameter signals exceed the reference signals
or not.
It is to be noted that the only effective difference which will
normally occur between the comparators 3a - 3d arises from the fact
that different reference level values will be appropriate to
different parameters.
The integrator/comparators 2a - 2d are also of similar form with
the only effective differences arising from the use of different
reference levels, and possibly different integration time
constants, for different parameters, and it is again convenient to
describe only one arrangement in more detail.
The relevant integrator/comparator is shown in more detail in FIG.
3 with further detail of parts thereof in FIG. 4.
FIG. 3 shows application of the relevant parameter signal to first
and second integrators 30 and 31 which are of similar form but
differ in respect of time constants such that they can be regarded
as respectively providing relatively short and long term integral
signals. More particularly, the integrating function in question is
the EMP referred to above and so integrators 30 and 31 can be
denoted as short and long EMP's. These integral signals are applied
to respective comparators 32 and 33 of similar overall kind denoted
as `type A` to provide first digital signals.
The two integral signals are also applied to a difference amplifier
34 to provide a difference signal. This last signal is applied, in
turn, to a comparator 35 of a kind denoted as `type B` and similar
to that of FIG. 2 except that different values of fixed high and
low reference signals will normally be appropriate, even for type B
comparators associated with the same parameter.
Lastly in FIG. 3, the transducer signal is applied to an up-dated
reference signal generator 36 the output of which is applied to the
two type A comparators 32 and 33.
The more particular form of the integrators 30 and 31 is shown by
FIG. 4, these two integrators being essentially the same except for
different time constant factors in integration. In FIG. 4 the
relevant transducer signal is applied as input voltage V.sub.I
through a grounded potentiometer 41 to produce an output voltage
a.V.sub.I. This output voltage is then applied as input to an
integrator 42 to produce a further output voltage V.sub.O which is
fed back to the integrator input through a second grounded
potentiometer 43 so that the feedback voltage is a.V.sub.O. The
output voltage V.sub.O then represents the EMP function for the
parameter denoted by the input V.sub. I, with the time factor of
the function being determined by the time constant of the
integrator.
The more particular form of the type A comparators 32 and 33 is
shown by FIG. 5, these two comparators being essentially the same
except for the provision of different reference level signals for
different parameters. As with the comparator of FIG. 2 in that the
input signal for comparison, in this case the relevant EMP output
voltage, is applied to both a high comparator 50 and a low
comparator 51, these comparators serve to compare the EMP signal
with respective high and low level reference signals from sources
52 and 53, and with respective further high and low level reference
signals from sources 54 and 55. The difference between these
reference signals is that the first two are not fixed, but are of a
variable up-dated form as will be explained hereinafter, while the
second two reference signals are of fixed form, different from, but
having a similar function to those of the type B comparator in
indicating a hazardous level for the relevant parameter. The
comparators 50 and 51 produce the previously mentioned first
digital signals to indicate when any of the high reference levels
are exceeded, or the low reference levels passed in a downward
sense, by the EMP.
The remaining FIG. 6 illustrates the manner in which the up-dated
reference level signals are provided for the type A comparators,
that is to say, it shows further detail of the up-dating reference
signal generator 36 of FIG. 3. This involves application of the
transducer signal to a further EMP integrator 60 of similar form to
that of FIG. 4 but which will be of yet longer time constant than
the long EMP integrator 31 of FIG. 3. The EMP signal is applied to
a summing amplifier 61 together with the desired reference level
signal which, initially, will be of first fixed value from a source
62, and with a third input which is a second fixed value signal
from a source 63 representing the difference between the initial
EMP signal (the transducer signal) and the first fixed value
signal. The output of the amplifier 61, denoted as -.epsilon., is
applied to a potentiometer 64 to produce a signal -.DELTA..epsilon.
which is a small fraction of the potentiometer input, and this
fraction signal is applied in turn to an integrator 65 together
with the first fixed signal from source 62. The integrator output
is the desired variable reference level and this is fed back to the
summing amplifier through an inverter 66.
It will be appreciated that the up-dated reference signal
represents a common factor and is applied to both of the high and
low reference sources 52 and 53 of the type A comparator of FIG. 5,
while other individually different factors in both of these sources
make appropriate adjustment of the in-coming signal for the
purposes of the respective reference levels.
It remains to discuss some more general points relevant to the
above embodiment. Reference has been made to short and long term
EMP functions and the introduction of the specification indicates
pertinent orders of time constants for such functions. In practice,
it is presently considered desirable to use increased terms for at
least some of the parameters and the short term EMP function can
have a time constant of up to above 5 minutes, and the long term
EMP function up to about 40 minutes. The other EMP function of
interest is that relevant to the up-dated reference signals, and
this can have a time constant of up to about 4 hours.
It is also useful to mention some combinations of the digital
signals which are effective in indicating a patient's condition
which requires attention. For example: a warning state is denoted
by the combination of a trend to a low level over a long term for
mean arterial blood pressure with a trend to high level over a long
term for pulse rate; while an alarm state is denoted by a
combination of a trend to a high level, negative long term/short
term difference signal for mean arterial blood pressure with a
trend to a high long term/short term difference signal, whether
positive or negative, for pulse rate.
* * * * *