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FIELD OF THE INVENTION
This invention relates to a device which provides a substantially
continuous indication of the well-being of a patient. More particularly,
the invention provides a detector of respiration (occurrence of breathing)
which is highly accurate in use, yet which is relatively uncomplicated and
inexpensive, and highly reliable and foolproof as compared to systems in
the prior art.
BACKGROUND AND OBJECTS OF THE INVENTION
It has long been recognized in the anesthetic and other health-care related
arts that monitoring respiration is a very reliable method of determining
whether a patient is still alive, and moreover one which provides an
instant indication of trouble, as compared with other life signs which
take longer periods to depart from normal values. Such an indication is of
great interest with patients undergoing surgery or in other
life-threatening situations, and in connection with infants who, as is
well-known, are subject to cessation of breathing (apnea) for no apparent
cause. Therefore, it is desirable that means be provided for monitoring
the continued breathing of an individual.
One method of monitoring breathing which has been extensively employed in
the prior art involves monitoring the difference in carbon dioxide
(CO.sub.2) content between an individual's inspired and expired gas
streams. It is impossible to breathe without the CO.sub.2 content of the
expired gas stream varying from that of the inspired gas stream by at
least about 2%.
The prior art has recognized the above, yet applicant is aware of no system
in the prior art which simply monitors the relative CO.sub.2 content of
the inspired stream and that of the expired stream and uses these to
provide an indication of proper breathing or not, as the case may be.
Instead, the prior art, as exemplified by the Hewlett-Packard Model 47210A
capnometer, has tended toward systems of ever-increasing complexity and
cost, providing in many cases values for the absolute amount of CO.sub.2
present in the expired stream, which is unnecessary for a life monitor.
Applicant has realized that all that needs to be detected is the relative
difference in the CO.sub.2 contents of the inspired and expired streams.
It seems, therefore, that a need exists in the art for a simplified and
improved respiration monitor of reduced complexity and cost, which
operates by simply comparing the relative CO.sub.2 contents of the
inspired and expired gas streams, and to provide such is accordingly an
object of the invention.
The prior art has generally monitored the amount of CO.sub.2 in a gas
stream using infrared absorption measurement techniques. According to this
technique, an infrared light source radiates through a cuvette having
spaced parallel windows in which is enclosed a sample of the gas to be
monitored. The radiation then falls on a suitable detector, typically a
Golay cell such as Beckman Instruments' Model LB-2, which is highly
sensitive to acoustic noise, or a PbSe photodetector, which is very
sensitive to low-frequency noise, a significant defect in the environment
of this invention.
It is an object of this invention to avoid use of these and other
non-optimal detectors.
According to one aspect of the invention, radiation is monitored by a
thermopile (a combination of a number of individual thermistors, so as to
be very sensitive to small temperature changes). Such thermopiles are
useful even at low frequencies and in connection with D.C., unlike the
other detector types mentioned.
As in the prior art, the detector output is monitored. As infrared
radiation of particular wavelengths is preferentially absorbed by carbon
dioxide, the output of a detector sensitive to those wavelengths provides
an inverse indication of the relative amount of CO.sub.2 in the gas
stream. By calibration using a sample of known concentration, or possibly
by other methods, the detector can be made to yield quite accurate
results; however, as mentioned above, the object of the invention is not
so much to provide intrinsically accurate results concerning the actual
amount of CO.sub.2 present in a patient's exhaled gas stream, but merely
to determine whether the patient is breathing. Therefore, according to the
invention, calibration is ordinarily not performed, and the instrument is
simply operated so as to detect variation in the CO.sub.2 contents of the
inspired and expired gas streams.
Accordingly, it is an object of the invention to provide a respiration
detector which operates by detecting the differences between the CO.sub.2
concentration of inspired and expired gas streams, by providing a source
of infrared radiation disposed in juxtaposition to a cuvette containing
the gas stream to be measured, and by monitoring the output of a
thermopile disposed opposite the infrared source on the other side of the
cuvette, which does not require calibration for proper operation.
It will be appreciated by those skilled in the art that measurement of the
CO.sub.2 content of a sample by radiation adsorption techniques is subject
to error due to a number of factors. Though as mentioned above, the
invention of the applicants is not so much concerned with measurement of
the absolute value of the CO.sub.2 in the patient's breath as between the
relative difference in CO.sub.2 content between the inspired and expired
streams, it is nevertheless desirable that the instrument be operated in
the optimal fashion and furthermore that it be enabled to operate under
less than ideal conditions which may include, for example, clouding of the
windows through which the infrared beam passes due to humidity,
temperature drift and the like. Further, it is desirable that the
instrument measure the relative difference in the CO.sub.2 contents of the
streams accurately regardless of their absolute value, i.e. whether the
difference is between 0 and 3% CO.sub.2 or between 6 and 9%. Finally, it
is desirable that the absolute amount of radiation incident on the
thermopile be substantially constant so that it can be well matched to the
input value which provides the greatest dynamic range in the thermistor
output signal.
For all of the above reasons, it is desirable that means be provided to
regulate the intensity of the radiation falling on the thermopile, so as
to compensate the system for all the sources of possible error discussed
above.
In the preferred embodiment, this is achieved by provision of a feedback
loop connecting the output of the thermopile with the power supply which
is used to operate the source of infrared radiation. Use of feedback in a
loop having a low pass filter therein ensures that variation in the
inspired and expired gas stream will not cause the bulb output to vary,
while ensuring that the mean output of the thermopile is maintained at a
substantially constant level, thus compensating for all the sources of
error just discussed.
The selection of the infrared source has also been a source of some
difficulty and expense in the prior art. The applicant has realized that,
by using certain ordinary incandescent lamp bulbs, an adequate amount of
infrared light of suitable wavelength is provided to enable suitable
detection, thus further simplifying and reducing the cost of the apparatus
of the invention.
It is therefore an object of the invention to further simplify and reduce
the cost of the apparatus of the invention by using an inexpensive source
of infrared radiation.
The prior art has also used costly sapphire windows for the windows of the
cuvette. It is an object of the invention to avoid use of such materials.
It will be appreciated by those skilled in the art that the output of
typical thermopiles is a relatively small voltage, usually on the order of
millivolts. It will further be appreciated by those skilled in the art
that in the typical hospital operating room environment of today, there
are frequently a large number of electronic devices, some of which may not
be properly shielded. Accordingly, it is desirable that the instrument be
designed in such a way as to be less sensitive to electromagnetic noise
than otherwise, and furthermore that the signal processing circuitry to
which the thermopile is connected be enabled to differentiate between
noise and signal insofar as reasonably possible, given the goals of
simplicity and low cost, as discussed above, and such is accordingly an
additional object of the invention.
It is furthermore desirable that the gas stream be monitored as closely to
the patient as possible, to obtain accurate results. Accordingly, the
sensor of the respiration monitor of the invention should be lightweight,
so as to be attachable directly to flexible tubing connected closely to
the patient while still achieving the other objects of the invention
discussed above, and such is accordingly an additional object of the
invention.
SUMMARY OF THE INVENTION
The present invention fulfills the needs of the art and the objects of the
invention mentioned above by its provision of a simple and reliable, yet
highly accurate and useful, respiration detector. The detector according
to the invention comprises one or more common light bulbs juxtaposed to a
window in a housing. The housing is shaped so that this window and an
opposing window, behind which is disposed a thermopile, may be simply
"clipped" over corresponding windows in a cuvette connected to an
endotracheal tube, to a source of inspired gas and to a receptacle for
expired gas. The thermopile is connected to an instrumentation
preamplifier which is carried directly in the housing so as to amplify the
small voltage signals output by the thermopile as soon as possible in
order to minimize the risk of any interference. The sensor and
preamplifier assembly is additionally shielded against electromagnetic
interference. The output of the amplifier also is provided to the light
bulbs which provide the infrared radiation, for feedback purposes, to
ensure that the baseline level of the system remains relatively constant
over time. The system is connected to relatively straightforward signal
processing circuitry which includes means for differentiating the input
signal. Such differentiation provides an indication of the rate at which
the CO.sub.2 concentration changes, which can be used to differentiate
between changes in signal level caused by variation in the CO.sub.2
content due to breathing and relatively spike-like noise pulses, which is
the more common type of high amplitude noise. Low amplitude noise is
distinguished from breath signals by requiring that the breath signal
exceed a predetermined amplitude before a breath is considered to be
detected. The differentiated breath signal plus the expired breath signal
and the relative time of events determined therefrom are supplied to
signal processing circuitry which operates according to predetermined
rules of logic to generate an alarm signal when cessation of breathing has
been correctly detected.
BRIEF DESCRIPTION OF THE DRAWINGS
The invention will be better understood if reference is made to the
accompanying drawings in which:
FIG. 1 shows respective views of the sensor assembly according to the
invention and how it may be attached to a "wye"-shaped cuvette in the
patient's gas circuit;
FIG. 2 shows a cross-sectional view of the sensor assembly;
FIG. 3 shows a block diagram of the sensor and signal processing circuitry
employed; and
FIG. 4 shows typical waveforms obtained from the breath detector useful in
understanding the way in which the signal processing circuitry interprets
the signals shown.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
FIG. 1 shows the sensor assembly 10 according to the invention which is
generally H-shaped. The assembly 10 comprises a unitary housing molded of
a plastic material and typically comprising two parallel members 10a and
10b having windows 10c facing one another. Behind one of the windows is
disposed a thermopile and behind the other is disposed the source of
infrared radiation. The crossbar 10d of the housing 10 is provided with
some slight amount of flexibility so that, by an operator placing his
fingers on opposed pads 10e on the lower ends of the parallel members 10a
and 10b and exerting pressure thereagainst, the upper ends can be sprung
slightly outwardly to permit the ends having the windows 10c to be
inserted into recesses 12a formed in the mating cuvette 12.
The cuvette 12 in the embodiment shown is wye-shaped. One leg of the wye is
connected to a source of inspired gas, which may be anesthetic or the
like, including air, one to a receptable for expired gas, and one to a
fitting 14 to which is connected an endotracheal tube connected to the
patient. Recesses 12a with windows 16 formed therein are provided on
either side of the cuvette 12 so that when the sensor housing 10 is
assembled to the cuvette 12, the windows 10c in the ends of housing 10 are
juxtaposed directly to the windows 16 in the cuvette, so that a sample of
the gas in the cuvette is interposed between the thermopile and the
infrared source.
FIG. 2 shows a cross-sectional schematic view of the sensor housing 10 and
its contents. Preferably, the entire assembly is enclosed in a molded
plastic housing with appropriate recesses formed therein to hold the
various components shown. At 20 are shown a plurality of light bulbs which
provide infrared radiation. These may be the Model 7153-T7/8 from Lamp
Technology, Incorporated of Farmingdale, N.Y. They are disposed behind a
first plastic window 22 which may be made of polycarbonate on the order of
1-5 mils thick to ensure good infrared light transmission. A wide variety
of polycarbonate plastics are suitable. Behind the bulbs 20 is disposed a
parabolic mirror 21 which ensures that the light generated by the bulbs is
all directed toward a thermopile 28, increasing the sensitivity of the
instrument for a given power consumption. (In this connection, the
applicants have found that the optimum source-to-detector distance is 2.5
cm.) A similar window 24 is formed in the opposed portion of the H-shaped
sensor housing 10, behind which is disposed an interference filter 26, and
the thermopile 28. The interference filter, which may be a 4.25 micron
narrow-band interference filter from Optical Coating Laboratory, Inc. of
Santa Rosa, Ca., is used to prevent incidence of radiation other than of
4.25 micron wavelength, which is selectively absorbed by CO.sub.2, on the
thermopile 28. The thermopile 28, as mentioned above, comprises a number
of individual thermocouples in series so as to generate a detectable
voltage proportional to the amount of infrared radiation falling thereon.
The Model 2M from the Dexter Research Company of Dexter, Mich. has been
found suitable. Preferably, the thermopile housing is sealed after
assembly and filled with a gas such as argon, which does not absorb
infrared radiation. As discussed above, infrared radiation is absorbed by
CO.sub.2 ; therefore, monitoring of the voltage signal generated by the
thermopile provides comparison of the CO.sub.2 content of the inspired gas
with that of the expired gas. If the comparison indicates a difference in
CO.sub.2 content equal at least to a predetermined percentage and certain
other parameters of breathing discussed below are detected, it can safely
be concluded that the patient is breathing, absorbing oxygen and exhaling
CO.sub.2.
The thermopile 28 is connected to a preamplifier 30. In the preferred
embodiment, this may comprise a Model AD524 instrumentation amplifier or
equivalents thereof. An op amp (not shown) controlling the power supply
for the bulbs 20 may also be disposed within the sensor housing 10. The
output signal from the preamp 30 may be fed to the op amp for low-pass or
integral feedback control of the bulb output, such that the mean intensity
of the radiation incident on the thermopile is maintained constant. Power
is supplied to the system over a cable 32 connected to the signal
processing electronics; this cable also carries the output signal from
preamp 30. The thermopile, the preamp, and any additional op amp used are
carried on a single printed circuit board indicated generally at 34, and
the entire assembly is preferably enclosed in an electromagnetic shield 36
indicated by dotted lines. Provision of the preamplifier 30 inside the
electromagnetic shield 36 with the thermopile 28 provides a reasonable
measure of immunity against electromagnetic interference from other
electronic instruments in the operating room.
The outline of the sensor housing is shown as well at 38. The housing may
conveniently comprise a substantially identical pair of injection moldings
provided with appropriate recesses to hold the various parts shown in the
drawing of FIG. 2, and provided with sufficient flexibility in the bridge
section of the H shape formed by the housing to allow the ends of its two
legs 10a and 10b carrying the thermopile and the bulbs to be sprung apart
by pressure on opposing ends of the legs.
FIG. 3 shows the signal processing electronics according to the invention
in block diagram form; the Figure also shows some of the components shown
in FIG. 2 for completeness. A single infrared bulb 20 is shown disposed on
one side of the cuvette 12; on the other side of the cuvette are disposed
the interference filter 24 and the thermopile 28. The reflector 21 is also
shown. The gas cuvette comprises plastic windows, preferably formed
integrally, again of material which is relatively transparent to infrared
radiation such as polycarbonate plastics, as described above.
The output of the thermopile is connected to preamp 30 which is D.C.
referenced by a battery 42 or another voltage source connected between it
and ground. This permits the output of the preamp 30 to be passed to an op
amp 44 to drive the bulb 20 using feedback techniques, so that the level
of radiation incident on the thermopile remains constant over time,
regardless of such things as window clouding, temperature-induced
component drift, and so on. The output of preamp 30 is a signal
proportional to the CO.sub.2 level in the patient's breath, referred to
hereafter as signal E. Signal E thus includes a portion proportional to
the CO.sub.2 content of both the inspired and expired gas streams, which
correspond respectively to the "valleys" and "peaks" in signal E. Thus
monitoring of the difference between the peaks and valleys of signal E in
effect provides a measure of the difference in CO.sub.2 content between
the inspired and expired streams.
Signal E is also supplied to a differentiator 46 in which it is
differentiated; the output of differentiator 46 is referred to as the
differentiated signal DE. Finally, a system clock 48 provides time signals
as a third input to the breath identification logic 50, which is detailed
below. The output of the logic 50 is sent to alarm decision circuitry 52
which raises an alarm when apnea is detected by sounding an alarm 54.
Those of skill in the art will recognize that, in addition to a patient's
lack of breathing due to some physical irregularity, sometimes the sensor
may be detached from the processing equipment, the plumbing connecting the
patient with the equipment may be blocked and so on. It is also desirable
to provide signals indicative of such failures, in particular, to give
signals which will assist the operating room personnel in finding the
cause of the alarm. The logic now to be described provides signals
indicating sensor obstruction and sensor detachment, which occasionally
occur.
In one embodiment of the invention which was successfully tested, the
output signal E and the differentiated version thereof DE are compared by
four comparators (not shown) to reference levels. These are referred to in
the following as R.sub.EL (reference signal low), R.sub.EH (reference
signal high), R.sub.DEL (reference derivative signal low) and R.sub.DEH
(reference derivative signal high). Additionally, the source of the
voltage, that is, the output of op amp 44, which drives the bulb 20, is
additionally monitored to confirm that there is adequate infrared
radiation incident on the thermopile to enable accurate detection. This
signal is referred to as S; S is similarly compared to reference values to
yield values of R.sub.SL (reference source voltage low) and R.sub.SH
(reference source voltage high).
From these comparators, additional signals used by the logic are derived as
follows:
EL=E>R.sub.EL, that is, EL is true whenever the breath signal E is greater
than the reference level R.sub.EL ;
EH=E>R.sub.EH, that is, EH is true whenever the signal E is greater than
R.sub.EH ;
DEL=DE>R.sub.DEL, that is, DEL is true when the derivative DE of the signal
E is greater than the reference derivative signal low level R.sub.DEL ;
DEH=DE>R.sub.DEH, that is, DEH is true whenever the derivative DE of the
signal E is greater than the reference derivative signal high level
R.sub.DEH ;
SL=S>R.sub.SL, that is, SL is true whenever the source voltage S is greater
than the reference low source voltage R.sub.SL ; and
SH=S>R.sub.SH, that is, SH is true whenever the source voltage S is greater
than the reference high source voltage R.sub.SH.
The signals just defined are used by the processing circuitry as follows:
1. If SL and SH and ((DEL and not DEH) in last N ms) and EH and (EL in last
M ms) and (BREATH for P ms.)
Then BREATH
According to the above equation, if the source voltage is correct (SL and
SH) and the derivative signal, that is, the value of the rate of change of
the CO.sub.2 content, is within limits (DEL and not DEH) for a specified
period N, and EH is true, indicating that the peak of the CO.sub.2 value
is greater than the reference value R.sub.EH set to correspond to the
anticipated CO.sub.2 level of expired gas, and EL has been true for the
period M (EL in last M ms), that is, that the CO.sub.2 level for the
inhaled stream has been below the reference level R.sub.EL for the period
M, and BREATH has not been true for some period of time P, then the signal
BREATH is generated, indicating successful detection of a breath.
The above description of the logic detection of a breath can be summarized
as follows. The source voltage is first checked. The values of the
derivatives are checked so as to eliminate noise as an erroneous source of
CO.sub.2 measurement. The peak of the CO.sub.2 signal is checked against a
reference level and the lower level, that is, the CO.sub.2 content of the
inspired air is also checked, so as to confirm that the difference in
CO.sub.2 gas streams between the inspired and expired level is at least
equal to the difference between R.sub.EL and R.sub.EH. Finally, this logic
confirms that the last BREATH signal was present so as to continue to give
the alarm, even if a subsequent breath is detected.
2. If BREATH for R sec then APNEA
This simply indicates that after no BREATH signal has been detected for a
period of time R, the APNEA signal is raised.
3. If SL then SENSOR DETACH
This item simply indicates that if the SL signal is negative, this means
that the source voltage has disappeared, ordinarily because the sensor has
become detach from the cuvette.
4. If SH then SENSOR OBSTRUCT
Similarly, if SH goes high, this means the sensor is obstructed, e.g. by
mucus or humidity blocking the passage of radiation, preventing adequate
absorption of CO.sub.2 by the thermopile.
5. If APNEA and SENSOR DETACH and SENSOR OBSTRUCT, then APNEA ALARM and
APNEA LIGHT.
Thus, if the APNEA signal is raised and the SENSOR DETACH and SENSOR
OBSTRUCT signals are not raised, the APNEA ALARM signal is given. In a
preferred embodiment, a light on the control box is also lit in this
circumstances; hence, the APNEA LIGHT signal is also energized.
6. If APNEA and SENSOR DETACH or SENSOR OBSTRUCT, then APNEA ALARM and
APNEA LIGHT.
If, on the other hand, the APNEA signal and either the SENSOR DETACH or
SENSOR OBSTRUCT signals are raised simultaneously, then the light is lit
but the APNEA ALARM is not energized, indicating that some other problem
is present which must be corrected.
A worker of ordinary skill in the bioelectronic art would have no
difficulty in designing logic circuitry to implement the above.
FIG. 4 is an example of actual waveforms useful in understanding the
operation of the system of the invention, in particular the logic which
has just been described. The upper chart in FIG. 4 shows the signal E
proportional to the voltage generated by the thermopile and the lower
chart shows signal DE, the differentiated version of signal E. The
reference levels R.sub.EL and R.sub.EH are shown in the upper graph as are
R.sub.DEH and R.sub.DEL on the lower graph. Thus, each of the
negative-going peaks on the upper graph represents a change in CO.sub.2
content which might be interpreted as indicative of a breath. The first
negative-going peak X is recognized as a breath because the value
corresponding to the DE signal has exceeded R.sub.DEL but not R.sub.DEH in
the last N ms; the E signal has gone from A to B in the last M ms; and no
breath has occurred in the last P ms. Peak S is similar. By comparison,
peak Y, appearing in the lower graph, would not be recognized as a breath
because the amplitude criteria have not been met by the E signal. Item Z
is clearly noise, as the value of the derivative signal DE exceeds the
maximum amplitude R.sub.DEH, indicating that the CO.sub.2 concentration
had changed too abruptly to have been a legitimate breath. Item H would
not be a breath because DE exceeded R.sub.DEL within N ms. Again, this is
due to the electrical noise. Item G would be rejected as a breath because
the derivative criteria have not been met, the amplitude criteria were not
met, i.e., G does not exceed R.sub.EH, and a breath has occurred within P
ms, at S. Finally, item I would be rejected as motion disturbance because
it had been more than N ms. since the E signal exeeded R.sub.EL at H. That
is, the derivative criteria again were not met.
It will be appreciated that while a preferred embodiment of the invention
has been described, additional modifications and improvements thereto
could be made by those skilled in the art without departure from the
spirit and scope of the invention. In particular, while essentially analog
signal processing circuitry has been described, microprocessor
implementation is well within the skill of the art; typically, the expired
signal would be converted from an analog to a digital value, possibly by a
suitable converter mounted on the same printed circuit board as the preamp
30 shown in FIG. 2, so as to provide additional noise immunity. Other
improvements and modifications will no doubt occur to those skilled in the
art including such things as modification of the cuvette design shown, and
inclusion of the cuvette within a housing carrying the signal processing
and logic circuitry rather than providing a relatively lightweight
portable sensor and forming the cuvette as part of the breathing tube
itself, as described above. Therefore, the above exemplary description of
the invention should be construed liberally and not as a limitation on the
scope of the invention, which is to be limited only by the following
claims.
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