U.S. patent application number 13/396430 was filed with the patent office on 2012-06-07 for method and circuit for indicating quality and accuracy of physiological measurements.
This patent application is currently assigned to TYCO HEALTHCARE GROUP LP. Invention is credited to Clark Baker, Michael Bernstein, Paul Mannheimer, Charles Porges, Thomas J. Yorkey.
Application Number | 20120143025 13/396430 |
Document ID | / |
Family ID | 22438764 |
Filed Date | 2012-06-07 |
United States Patent
Application |
20120143025 |
Kind Code |
A1 |
Porges; Charles ; et
al. |
June 7, 2012 |
METHOD AND CIRCUIT FOR INDICATING QUALITY AND ACCURACY OF
PHYSIOLOGICAL MEASUREMENTS
Abstract
Sensors and monitors for a physiological monitoring system
having capability to indicate an accuracy of an estimated
physiological condition. The sensor senses at least one
physiological characteristic of a patient and is connectable to a
monitor that estimates the physiological condition from signals
detected by the sensor. The sensor includes a detector for
detecting the signals from the patient which are indicative of the
physiological characteristic. The sensor is associated with a
memory configured to store data that defines at least one sensor
signal specification boundary for the detected signals. The
boundary is indicative of a quality of the signals and an accuracy
of the physiological characteristic estimated from the signals by
the monitor. The sensor further includes means for providing access
to the memory to allow transmission of the data that defines the at
least one sensor boundary to the monitor.
Inventors: |
Porges; Charles; (Orinda,
CA) ; Baker; Clark; (Castro Valley, CA) ;
Yorkey; Thomas J.; (San Ramon, CA) ; Bernstein;
Michael; (San Ramon, CA) ; Mannheimer; Paul;
(Danville, CA) |
Assignee: |
TYCO HEALTHCARE GROUP LP
Mansfield
MA
|
Family ID: |
22438764 |
Appl. No.: |
13/396430 |
Filed: |
February 14, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11241635 |
Sep 30, 2005 |
8133176 |
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13396430 |
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10712895 |
Nov 12, 2003 |
7457652 |
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11241635 |
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09545170 |
Apr 6, 2000 |
6675031 |
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10712895 |
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60129170 |
Apr 14, 1999 |
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Current U.S.
Class: |
600/323 ; 29/825;
600/300 |
Current CPC
Class: |
A61B 5/14551 20130101;
A61B 5/7221 20130101; Y10T 29/49117 20150115 |
Class at
Publication: |
600/323 ;
600/300; 29/825 |
International
Class: |
A61B 5/1455 20060101
A61B005/1455; H01R 43/00 20060101 H01R043/00; A61B 5/00 20060101
A61B005/00 |
Claims
1-22. (canceled)
23. A method of manufacturing a system, comprising: providing a
sensor comprising a detector configured to generate signals that
are indicative of a physiological characteristic of a patient;
providing a memory coupled to the sensor, the memory storing data
defining at least one sensor signal specification boundary for the
signals, the at least one sensor signal specification boundary
being indicative of a quality of the signals and an accuracy of an
estimated physiological condition of the patient; and providing a
monitor configured to receive the signals indicative of the
physiological characteristic from the sensor, to provide the
estimated physiological condition of the patient based on the
signals, to receive the data defining the at least one sensor
signal specification boundary for the signals from the sensor, to
compare the signals against the at least one sensor signal
specification boundary, and to generate an indication of the
accuracy of the estimated physiological condition.
24. The method of claim 23, wherein the sensor signal specification
boundary includes one or both of limits for an AC modulation
component and limits for a DC component.
25. The method of claim 24, wherein the monitor is configured to
calculate values having AC and DC components from the signals.
26. The method of claim 25, wherein the AC and DC components are
dependent on either a physiological status of the patient, sensor
type, or sensor location.
27. The method of claim 22, wherein the physiological
characteristic comprises arterial oxygen saturation.
28. A method of operating a system for detecting at least one
physiological characteristic of a patient, comprising: generating,
with a sensor, signals from the patient that are indicative of the
physiological characteristic; accessing a memory coupled to the
sensor to facilitate transmission of data defining at least one
sensor signal specification boundary, the at least one sensor
signal specification boundary being indicative of a quality of the
signals and an accuracy of an estimated physiological condition of
the patient; transmitting from the sensor to a monitor the signals
indicative of the at least one physiological characteristic;
determining the estimated physiological condition of the patient
via the monitor based on the signals; transmitting data defining
the at least one sensor signal specification boundary for the
signals from the sensor to the monitor; comparing via the monitor
the signals against the sensor signal specification boundary; and
generating via the monitor an indication of the accuracy of the
estimated physiological condition.
29. The method of claim 28, wherein the sensor signal specification
boundary includes one or both of limits for an AC modulation
component and limits for a DC component.
30. The method of claim 29, comprising calculating via the monitor
values having AC and DC components from the signals.
31. The method of claim 30, wherein the AC and DC components are
dependent on either a physiological status of the patient, sensor
type, or sensor location.
32. The method of claim 28, wherein the physiological
characteristic comprises arterial oxygen saturation.
33. A monitor for providing an indication of an accuracy of an
estimated physiological condition of a patient, the monitor being
coupleable to a sensor that generates signals indicative of at
least one physiological characteristic of the patient, the monitor
comprising: a first receiving circuit configured to receive the
signals from the sensor; a first processing circuit configured to
provide an estimated physiological condition of the patient based
on the signals; a second receiving circuit configured to receive
data defining at least one sensor signal specification boundary for
the signals from the sensor, the sensor signal specification
boundary being indicative of a quality of the signals and an
accuracy of the estimated physiological characteristic; and a
second processing circuit configured to compare the signals against
the at least one sensor signal specification boundary and to
generate an indication of the accuracy of the estimated
physiological condition.
34. The monitor of claim 33, wherein the sensor signal
specification boundary includes one or both of limits for an AC
modulation component and limits for a DC component.
35. The monitor of claim 34, comprising a third processing circuit
configured to calculate values having AC and DC components from the
signals.
36. The monitor of claim 35, wherein the AC and DC components are
dependent on either a physiological status of the patient, sensor
type, or sensor location.
37. The monitor of claim 33, wherein the physiological
characteristic comprises arterial oxygen saturation.
38. A system for detecting at least one physiological
characteristic of a patient, comprising: a sensor, comprising: a
detector configured to generate signals that are indicative of the
at least one physiological characteristic; a memory coupled to the
sensor, the memory storing data defining at least one sensor signal
specification boundary for the signals, the sensor signal
specification boundary being indicative of a quality of the signals
and an accuracy of an estimated physiological condition of the
patient, wherein the sensor signal specification boundary includes
limits for an AC modulation component and DC component of the
signals; and an integrated circuit providing access to the memory
to facilitate transmission of the data defining the at least one
sensor signal specification boundary; and a monitor, comprising: a
receiving circuit configured to receive communications relating to
signals indicative of the at least one physiological characteristic
from the sensor and data defining the at least one sensor signal
specification boundary for the generated signals from the sensor;
and a processing circuit configured to determine the estimated
physiological condition of the patient based on the signals,
compare the signals against the at least one sensor signal
specification boundary, generate an indication of the accuracy of
the estimated physiological condition, and determine whether the
received signals are within a normal signal regime or an abnormal
signal regime.
39. The system of claim 38, wherein the processing circuit is
configured to calculate values having AC and DC components from the
signals.
40. The system of claim 39, wherein the AC and DC components are
dependent on either a physiological status of the patient, sensor
type, or sensor location.
41. The system of claim 38, wherein the monitor comprises an alarm
that is triggered when the signals move from the normal regime to
the abnormal regime.
42. The system of claim 38, wherein the physiological
characteristic comprises arterial oxygen saturation.
Description
[0001] This application claims the benefit of U.S. Provisional
Application Ser. No. 60/129,170, filed Apr. 14, 1999, which is
incorporated herein by reference.
BACKGROUND OF THE INVENTION
[0002] The present invention relates to physiological monitoring
instruments and, in particular, monitors and sensors that include
mechanisms for indicating a quality of detected signals and
accuracy or confidence level of physiological measurements
estimated from the signals.
[0003] Typically, for physiological monitoring instruments that
include a monitor and a patient sensor, the monitor is unable to
accurately determine a quality of a signal obtained from the
sensor. The invention will be explained by reference to a preferred
embodiment concerning pulse oximeter monitors and pulse oximetry
sensors, but it should be realized the invention is applicable to
any generalized patient monitor and associated patient sensor. The
invention provides a way of more accurately determining a quality
of a signal detected by a sensor; a way of determining a relative
accuracy of a physiological characteristic derived or calculated
from the signal; and a way of delineating a transition boundary
between a normal signal for the sensor being used in its normal
application, and a signal considered to be abnormal for the sensor
being used, to allow a monitor to determine if the sensor is being
misapplied.
[0004] Pulse oximetry is typically used to measure various blood
flow characteristics including, but not limited to, the blood
oxygen saturation of hemoglobin in arterial blood and the heartbeat
of a patient. Measurement of these characteristics has been
accomplished by the use of a non-invasive sensor that passes light
through a portion of a patient's blood perfused tissue and
photo-electrically senses the absorption and scattering of light in
such tissue. The amount of light absorbed and scattered is then
used to estimate the amount of blood constituent in the tissue
using various algorithms known in the art. The "pulse" in pulse
oximetry comes from the time varying amount of arterial blood in
the tissue during a cardiac cycle. The signal processed from the
sensed optical signal is a familiar plethysmographic waveform due
to the cycling light attenuation.
[0005] The light passed through the tissue is typically selected to
be of two or more wavelengths that are absorbed by the blood in an
amount related to the amount of blood constituent present in the
blood. The amount of transmitted light that passes through the
tissue varies in accordance with the changing amount of blood
constituent in the tissue and the related light absorption.
[0006] To estimate arterial blood oxygen saturation of a patient,
conventional two-wavelength pulse oximeters emit light from two
light emitting diodes (LEDs) into a pulsatile tissue bed and
collect the transmitted light with a photodiode (or photo-detector)
positioned on an opposite surface (i.e., for transmission pulse
oximetry) or an adjacent surface (i.e., for reflectance pulse
oximetry). The LEDs and photo-detector are typically housed in a
reusable or disposable oximeter sensor that couples to a pulse
oximeter electronics and display unit. One of the two LEDs' primary
wavelength is selected at a point in the electromagnetic spectrum
where the absorption of oxyhemoglobin (HbO.sub.2) differs from the
absorption of reduced hemoglobin (Hb). The second of the two LEDs'
wavelength is selected at a different point in the spectrum where
the absorption of Hb and HbO.sub.2 differs from those at the first
wavelength. Commercial pulse oximeters typically utilize one
wavelength in the near red part of the visible spectrum near 660
nanometers (nm) and one in the near infrared (IR) part of the
spectrum in the range of 880-940 nm.
[0007] Oxygen saturation can be estimated using various techniques.
In one common technique, first and second photo-current signals
generated by the photo-detector from red and infrared light are
conditioned and processed to determine AC and DC signal components
and a modulation ratio of the red to infrared signals. This
modulation ratio has been observed to correlate well to arterial
oxygen saturation. Pulse oximeters and sensors are empirically
calibrated by measuring the modulation ratio over a range of in
vivo measured arterial oxygen saturations (SaO.sub.2) on a set of
patients, healthy volunteers, or animals. The observed correlation
is used in an inverse manner to estimate blood oxygen saturation
(SpO.sub.2) based on the measured value of modulation ratios. The
estimation of oxygen saturation using modulation ratio is described
in U.S. Pat. No. 5,853,364, entitled "METHOD AND APPARATUS FOR
ESTIMATING PHYSIOLOGICAL PARAMETERS USING MODEL-BASED ADAPTIVE
FILTERING", issued Dec. 29, 1998, and U.S. Pat. No. 4,911,167,
entitled "METHOD AND APPARATUS FOR DETECTING OPTICAL PULSES",
issued Mar. 27, 1990. The relationship between oxygen saturation
and modulation ratio is further described in U.S. Pat. No.
5,645,059, entitled "MEDICAL SENSOR WITH MODULATED ENCODING
SCHEME," issued Jul. 8, 1997. All three patents are assigned to the
assignee of the present invention and incorporated herein by
reference.
[0008] The accuracy of the estimates of the blood flow
characteristics depends on a number of factors. For example, the
light absorption characteristics typically vary from patient to
patient depending on their physiology. Moreover, the absorption
characteristics vary depending on the location (e.g., the foot,
finger, ear, and so on) where the sensor is applied. Further, the
light absorption characteristics vary depending on the design or
model of the sensor. Also, the light absorption characteristics of
any single sensor design vary from sensor to sensor (e.g., due to
different characteristics of the light sources or photo-detector,
or both). The clinician applying the sensor correctly or
incorrectly may also have a large impact in the results, for
example, by loosely or firmly applying the sensor or by applying
the sensor to a body part which is inappropriate for the particular
sensor design being used.
[0009] Some oximeters "qualify" measurements before displaying them
on the monitor. One conventional technique processes (i.e.,
filters) the measured plethysmographic waveform and performs tests
to detect and reject measurements perceived corrupted and
inaccurate. Since oximeters are typically designed to be used with
a wide variety of sensors having widely differing performance
characteristics, the monitor signal "qualification" algorithms are
necessarily crude, and often result in only superficial indications
of signal quality, signal reliability, and ultimately a confidence
level in a patient physiological characteristic estimated or
calculated from the signal. In many instances, the monitor simply
discards data associated with low quality signals, but otherwise
gives no indication to a healthcare giver as to whether any
physiological characteristic displayed on a monitor is highly
reliable or not. Hence, the signal quality measurements obtained
from such crude algorithms are relatively poor and convey little
useful information to a caregiver.
SUMMARY OF THE INVENTION
[0010] Accordingly, it is an object of the present invention to
provide a patient monitor and sensor which includes means for
accurately detecting a quality of a signal detected by the
sensor.
[0011] Another object of the invention is to provide a monitor and
sensor which includes means for accurately determining a quality of
a physical characteristic estimated from a signal obtained by a
sensor.
[0012] A further object of the invention is to provide a monitor
and sensor which includes means for detecting a transition between
a signal regime considered normal for the sensor in its usual
application, and a signal regime considered to be abnormal.
[0013] These and others objects of the invention are achieved by
the use of a set of one or more signal specification boundaries.
Each boundary defines a region of a signal quality diagram and
corresponds to a different level of quality in the detected signals
and accuracy or confidence level of physiological characteristic
estimated from the detected signals. Boundaries can also be defined
for and associated with different sensor types and monitor types.
The boundaries are typically stored in a memory and accessed when
required.
[0014] An embodiment of the invention provides a sensor for sensing
at least one physiological characteristic of a patient. The sensor
is connectable to a monitor that estimates a physiological
condition from signals detected by the sensor. The sensor includes
a detector for detecting the signals from the patient which are
indicative of the physiological characteristic. The sensor is
associated with a memory configured to store data that defines at
least one sensor signal specification boundary for the detected
signals. The boundary is indicative of a quality of the signals and
an accuracy of the physiological characteristic estimated from the
signals by the monitor. The sensor further includes means for
providing access to the memory to allow transmission of the data
that defines the at least one sensor boundary to the monitor.
[0015] In an embodiment, the boundary is indicative of a transition
between a signal regime considered normal for the sensor in its
usual application, and a signal regime considered to be abnormal.
The normal regime can be one in which the sensor is likely to be
properly applied to the patient and the abnormal regime can be one
in which the sensor may have partially or entirely come off the
patient.
[0016] Another embodiment of the invention provides a monitor for
providing an indication of an accuracy of an estimated
physiological condition of a patient. The monitor is connectable to
a sensor that detects signals indicative of at least one
physiological characteristic of the patient. The monitor includes
at least one receiving circuit and at least one processing circuit.
The receiving circuit is configured to receive the signals
indicative of the at least one physiological characteristic and
data defining at least one sensor signal specification boundary for
the detected signals. The processing circuit is configured to
estimate the physiological condition of the patient based on the
received signals, compare the received signals against the at least
one sensor boundary, and generate the indication of the accuracy of
the estimated physiological condition. The monitor further includes
means for providing the indication of the accuracy of the estimated
physiological condition to a user of the monitor.
[0017] Yet another embodiment of the invention provides a pulse
oximetry system that includes the sensor described above and a
pulse oximetry monitor. The monitor has means to determine whether
the signals are within a normal regime or an abnormal regime. The
system further includes means for informing a user of the system as
to whether the signal is normal or abnormal.
[0018] The foregoing, together with other aspects of this
invention, will become more apparent when referring to the
following specification, claims, and accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] FIG. 1 shows a simplified block diagram of an embodiment of
a pulse oximeter system;
[0020] FIG. 2A shows a diagram of a specific embodiment of a
sensor;
[0021] FIGS. 2B and 2C show diagrams of specific embodiments in
which a memory is located within the sensor plug and within the
sensor cable, respectively;
[0022] FIG. 2D shows a diagram of a specific embodiment of a
monitor;
[0023] FIG. 3 shows a diagram of a simplified optical waveform
detected by the sensor;
[0024] FIG. 4 shows a signal quality diagram that includes data of
the measured DC and AC components;
[0025] FIG. 5 shows a signal quality diagram having defined regions
corresponding to different confidence levels in the saturation
estimate;
[0026] FIG. 6 shows a signal quality diagram having defined display
and non-display regions (similar to those of FIG. 5) and transition
zones;
[0027] FIG. 7 shows a flow diagram of an embodiment of the
measurement posting process of the invention;
[0028] FIG. 8 shows a signal quality diagram with data collected
from a patient population; and
[0029] FIG. 9 shows a signal quality diagram that includes
ambiguity contours plotted over a portion of the display
region.
DESCRIPTION OF THE SPECIFIC EMBODIMENTS
[0030] The invention is applicable to measurement (or estimation)
of oxygen saturation of hemoglobin in arterial blood and patient
heart rate. The invention will be described in detail with respect
to an embodiment for pulse oximetry, but it needs to be realized
that the invention has applicability to alternate patient
monitoring characteristics, such as ECG, blood pressure,
temperature, etc., and is not to be limited to only for use with
oximetry or pulse oximetry.
[0031] FIG. 1 shows a simplified block diagram of an embodiment of
a pulse oximeter system 100. System 100 includes a pulse oximeter
(or monitor) 110 that couples via an electrical cable 128 to a
sensor 130 that is applied to a patient 132. Sensor 130 includes a
sensor cable 129 and a connector plug 120. The sensor further has
first and second light sources (e.g., LEDs) and a photo-detector
along with suitable components to couple these electro-optical
components to the electrical cable 128.
[0032] As noted above, oxygen saturation can be estimated using
various techniques. In one common technique, the optical signals
are received by the photo-detector, and conditioned and processed
by the oximeter to generate AC and DC components. These components
are then used to compute a modulation ratio of the red to infrared
signals. The computed modulation ratio is then indexed against a
table to retrieve a saturation estimate corresponding to that
modulation ratio.
[0033] FIG. 2A shows a diagram of a specific embodiment of sensor
130. Sensor 130 includes two or more LEDs 230 and a photodetector
240. Sensor 130 may optionally include a memory 236a and an
interface 238. LEDs 230 receive drive signals that (i.e.,
alternately) activate the LEDs. When activated, the light from LEDs
230 passes into a patient's tissues 234. After being transmitted
through or reflected from the tissues, the light is received by
photo-detector 240. Photo-detector 240 converts the received light
into a photocurrent signal, which is then provided to the
subsequent signal-processing unit.
[0034] The sensor memory stores data representative of at least one
sensor signal specification boundary and provides the sensor
boundary when requested. Interface circuit 238 provides signal
conditioning, and can also provide other functions. Through
interface circuit 238, data is transferred to and from the sensor
memory. Memory 236a and interface circuit 238 can be integrated
within one integrated circuit for reduced size and cost.
[0035] The memory associated with the sensor can be physically
located in a variety of places. First, it can be located on the
body of the sensor, in a vicinity of the photodetector, LEDs, or
other sensor components. Or, the memory can be in the sensor cable
129 or the connector plug 120, or in an adapter module that
connects to a front of an oximeter, to an oximeter cable, or to a
sensor plug or cable.
[0036] FIG. 2B shows a diagram of a specific embodiment in which a
memory 236b is located within the connector plug 120. Memory 236b
couples to and interfaces with external circuitry through some or
all signal lines provided to the sensor plug.
[0037] FIG. 2C shows a diagram of a specific embodiment in which a
memory 236c is located within the sensor cable 129. Again, memory
236c couples to and interfaces with external circuitry through a
set of signal lines.
[0038] The memory 236 can be implemented as a random access memory
(RAM), a FLASH memory, a programmable read only memory (PROM), an
erasable PROM (EPROM), an electrically erasable PROM (EEPROM), a
write once memory, or other memory technologies capable of write
and read operations. In a specific embodiment, to preserve the data
stored in the memory and prevent accidental erasure, the sensor
memory can be written only once. This memory characteristic also
prevents erasure of the data during sensor operation. A specific
example of a memory device that can be written only once is a
2-wire EPROM device available from Dallas Semiconductor Corp.
[0039] FIG. 2D shows a diagram of a specific embodiment of monitor
110. A receiving circuit 250 couples to the sensor and the memory
associated with the sensor for receiving signals detected by the
sensor and data from the sensor memory. The receiving circuit 250
couples to a processing circuit 252 that processes the received
signals to generate an estimate of a physiological characteristic.
The processing circuit 252 can further generate an indication of
the quality of the received signal and an indication of the
accuracy of the estimated physiological characteristic. The
estimated physiological characteristic and associated indications
are provided to a display unit 254 for display to a user of the
monitor.
[0040] FIG. 3 shows a diagram of a simplified optical waveform 300
detected by a sensor (e.g., sensor 130). Optical waveform 300 in
FIG. 3 can represent the detected optical signal for either the red
or infrared LED. As shown in FIG. 3, optical waveform 300 includes
a periodic pattern that generally corresponds to a patient's
heartbeat. For arrhythmia patient, the waveform may be aperiodic.
Waveform 300 includes a series of peaks having a maximum value
(Max) and a series of valleys having a minimum value (Min). The
following quantities are defined:
AC = Max - Min ; Eq . ( 1 ) DC = ( Max - Min ) 2 ; Eq . ( 2 )
Modulation percentage ( Mod % ) = 100 ( AC DC ) ; and Eq . ( 3 )
nAv ( nanoAmperes virtual ) = DC Instrument gain 50 mA actual LED
drive current in mA Eq . ( 4 ) ##EQU00001##
where Instrument gain is a gain value that is specific to the
combination of the pulse oximeter and a particular sensor that is
used during the detection of the pulses in waveform 300.
Nanoamperes virtual "normalizes" the signal to a 50 mA LED drive.
Many oximeters contain servo systems which adjust LED drive
intensity to be optimal for a particular set of monitoring
conditions. By normalizing signal levels to a standard assumed LED
drive level, it is possible to derive a measure of signal strength
which is dependent primarily on the sensor and patient, and not on
particular drive level which the instrument has selected.
[0041] The modulation ratio of the red to infrared signals,
sometimes referred to as the "ratio of ratios" (Ratrat), can be
approximated as:
Ratrat .apprxeq. ( AC_Red DC_Red ) ( AC_IR DC_IR ) ; Eq . ( 5 )
##EQU00002##
where AC_Red and DC_Red are the respective AC and DC components of
the red LED, and AC_IR and DC_IR are the respective AC and DC
components of the infrared LED. Oxygenation derived from Ratrat
using equation (5) is sufficiently accurate for many applications
when the condition (AC<<DC) is satisfied. Particularly, the
approximation error is small when both AC terms in equation (5) are
less than ten percent of the related DC terms (i.e., both red and
infrared modulations are less than 10%).
[0042] As stated above, oxygen saturation is related to Ratrat. The
relationship between Ratrat and oxygen saturation is typically
plotted as a curve (i.e., saturation versus Ratrat) and stored as a
table in the memory within the oximeter. Subsequently, a calculated
Ratrat is used to index the table to retrieve an entry in the table
for the oxygen saturation estimate corresponding to that Ratrat.
The estimation of oxygen saturation using Ratrat is further
described in U.S. Pat. Nos. 4,911,167, 5,645,059, and
5,853,364.
[0043] Generally, the Red terms are measured in the red part of the
optical spectrum using the red LED, and the IR terms are measured
in the infrared part of the optical spectrum using the infrared
LED. The AC terms are generated by the blood pressure pulse and are
somewhat related to "perfusion." The DC terms are (inversely)
related to the "opacity" (or darkness) of the patient being
monitored and are somewhat related to "translucence." Generally,
the four terms in equation (5) are independent of each other.
However, empirical studies suggest that the two DC terms are
somewhat correlated (i.e., not wildly divergent), and patients who
are "opaque" tend to be opaque in both the red and infrared parts
of the spectrum.
[0044] It has been determined that the magnitudes of the DC and AC
components influence the accuracy of the saturation estimates and
these magnitudes depend on the sensor design being used, the
specifications of components used in the sensor, and how the sensor
has been applied to the patient. The invention advantageously
utilizes this knowledge to provide an oximeter system capable of
providing indications of the accuracy and reliability of the
saturation estimates. Additional features are provided by the
invention based on the analysis of the measured DC and AC
components, as described below.
[0045] FIG. 4 shows a signal quality diagram that includes data of
the measured DC and AC components. The vertical axis of the signal
quality diagram corresponds to the modulation percentage (Mod %)
which is calculated as shown in equation (3) for each of the red
and infrared signals. The horizontal axis corresponds to the DC
component and is in units of virtual nano Amperes (nAv) and is
given by equation (4). As shown in FIG. 4, both vertical and
horizontal axes are plotted on a logarithmic scale.
[0046] As noted above, the detected optical waveform includes an AC
component and a DC component. The DC component is plotted on the
horizontal axis and the ratio of AC to DC is expressed as a
percentage (e.g., Mod %) and plotted on the vertical axis. Since
two different optical signals are measured (i.e., for the red and
infrared wavelengths), two points are generated and plotted on the
signal quality diagram to uniquely identify the AC and DC
components of both the red and infrared optical signals. In FIG. 4,
the data points corresponding to the red wavelength are identified
by a square and the data points corresponding to the infrared
wavelength are identified by a diamond.
[0047] FIG. 4 shows the relative positions of two data points
associated with two patients on the signal quality diagram. For a
(stable) patient and over a short duration (i.e., of few pulses),
all four Ratrat constituents (Red AC, DC; and Infrared AC, DC)
remain approximately constant. The data points for patient A
indicate a patient with low light levels (i.e., low DC component
values) and low modulation (i.e., low Mod %). These data points
could correspond to data from, for example, a chubby, dark-skinned
neonate who has poor perfusion, or a reflectance sensor applied to
a poorly perfused site (i.e., on the foot). Conversely, the data
points for patient B indicate a very translucent patient with good
perfusion that results in high light levels and high
modulation.
[0048] The pair of data points for each patient, one data point for
red wavelength and one for infrared wavelength, defines the
patient's current (Ratrat) conditions. Equivalently, the pair of
data points describes the oximeter's "operating point," when the
oximeter is monitoring that patient. For a particular patient, the
pair of data points can be used to estimate the patient's
saturation using equation (5) and a table for saturation versus
Ratrat. For example, the Ratrat for patient A is approximately
0.12/0.25 or 0.48. For a typical oximeter, this Ratrat corresponds
to a saturation of approximately 100%. The Ratrat for patient B is
approximately 6/7 or 0.86, which corresponds to a saturation of
approximately 85%.
[0049] In an embodiment, for each particular combination of
oximeter model and sensor model, data points are collected for
numerous "patients." These data points can be collected under a
controlled test environment where true oxygen saturation is known,
and an accuracy of the saturation estimated from the red and
infrared signals can be determined. Based on the collected data,
the diagram can be partitioned into regions corresponding to
different levels of quality and accuracy in the saturation
estimate. The regions also indicate a quality of the detected
signals. Each region is defined by a signal boundary.
[0050] The signal boundaries are dependent on many factors such as
the monitor type, sensor type, specifications of components in the
sensor (e.g., wavelength, LED characteristics), and other factors.
In an embodiment, sensor specific boundaries are stored in the
sensor memory or other locations associated with the sensor.
[0051] FIG. 5 shows a sensor signal quality diagram having defined
regions corresponding to different confidence levels in the
saturation estimate. A display region 510 defines a portion of the
signal quality diagram associated with saturation estimates that
satisfy a predetermined quality and accuracy level and merit
posting (or displaying) on the monitor. Display region 510 includes
the set of "patient conditions" resulting in sufficiently accurate
saturation estimates for a particular application. Accordingly,
when the data points fall within display region 510, the saturation
estimate (which is derived from the data points) is posted.
Conversely, when the data points fall outside display region 510
into a non-display region 512, the saturation estimate
corresponding to these data points is not posted on the oximeter
display. Non-display region 512 lies outside, and generally
surrounds, display region 510.
[0052] The DC signal corresponding to the red LED is generally
"weaker" than the detected signal from the infrared LED. Since this
characteristic is known a priori, the oximeter can be designed to
account for this difference. In one implementation, the red LED is
associated with a first display region and the infrared LED is
associated with a second display region. For example, referring to
FIG. 5, the red display region is defined by lines 520, 522, 526,
and 528, and the infrared display region is defined by lines 520,
524, 526, and 530. Since the red signals are generally weaker than
the infrared signal, the boundary of the red display region tends
to be closer to the lower left corner of the signal quality
diagram.
[0053] The display region may be dependent on numerous operating
conditions. For example, ambient light typically adds to the
detected optical signals (i.e., increases the DC components) and
thus may alter the display region. In this case, the display region
could be adjusted to account for the perturbation of the signal
caused by the (or distortion introduced by) ambient light.
[0054] FIG. 6 shows a signal quality diagram having defined display
and non-display regions (similar to those of FIG. 5) and a
transition zone 614. Transition zone 614 includes regions of the
diagram that lie between the display and non-display regions. The
transition zone represents regions associated with a different
(e.g., intermediate) quality and accuracy level than those of the
display and non-display regions. A different set of criteria can be
used when evaluating data points that fall within the transition
zone, as described below.
[0055] The regions shown in FIGS. 5 and 6 are only representatives
of a particular oximeter/sensor combination and for a particular
set of operating conditions. Each oximeter (or each oximeter model
or type) is typically associated with its own set of display and
non-display regions, which may differ from those shown in FIGS. 5
and 6. Some oximeters may even have poorly defined non-display
regions, where the boundaries vary depending on a set of factors.
These factors include the signal-to-noise ratio (SNR) of the
oximeter, the amount of ambient light, the wavelength of the sensor
LEDs, and so on.
[0056] In an embodiment, the oximeter operates in accordance with
the following set of rules: [0057] If both data points (i.e., for
the red and infrared signals) fall within their respective display
regions, the oximeter posts the result (e.g., the saturation
estimate, and heart rate). [0058] If either data point falls within
its non-display region, the oximeter does not post the result.
[0059] In all other cases, the oximeter may or may not post the
result. These cases include instances in which one of the signals
falls in the transition zone and neither signal falls in the
non-display region.
[0060] Thus, the saturation estimate is posted if the modulation
percentage (Mod %) and the light level (DC components) for both the
red and infrared wavelengths fall within the bounded areas of their
respective display regions. In an embodiment, if the red signal
falls within the red non-display region or if the infrared signal
falls within the infrared non-display region, or both, then the
oximeter does not post the saturation estimate. It can be noted
that other sets of rules can also be applied. For example, in
another embodiment, the result is posted if one of the data points
falls within its display region and the other data point falls
within the transition zone. In yet another embodiment, the oximeter
posts the saturation estimate and also indicates either the regions
in which the data points fall or a confidence level based on the
regions in which the data points fall.
[0061] For clarity, FIG. 5 shows only display and non-display
regions. These regions correspond to data points that are to be
displayed and not displayed. However, additional regions can be
defined within the signal quality diagram, with the additional
regions corresponding to different confidence levels in the
saturation estimate. Generally, the confidence level is high for
data points that fall near the center of the diagram and decreases
as the data points move away from the center. For the embodiment
having multiple confidence levels, the oximeter can display the
saturation estimate along with the confidence level.
[0062] For example, an "inactive" region can be defined and used to
indicate when a sensor is not applied to a patient. The inactive
region may be used to detect and notify when the sensor has been
removed (i.e., fallen off) the patient. The inactive region lies
outside the display and transition regions, correlates to
measurements from sensors that are not attached to patients, and
typically comprises a portion of the non-display region. This
region can be defined through simulation or through empirical
measurements. The oximeter computes the data points in the manner
described above. If the data points fall inside the inactive
region, the oximeter displays an indication that the sensor has
been removed from the patient.
[0063] FIG. 7 shows a flow diagram of an embodiment of the
measurement display process of the invention. At a step 712, one or
more signals indicative of a physiological parameter are detected.
For an oximeter used to measure oxygen saturation, this detecting
step may include, for example, receiving optical signals from two
LEDs and conditioning these signals. At a step 714, the detected
signal(s) are processed to generate intermediate data points. For
oxygen saturation, this processing step may include filtering the
data samples to generate DC and AC components, and using these
components to generate the modulation percentage (Mod %). The
intermediate data points would include filtered values for the DC
component and computed values of the modulation percentage. The
intermediate data points are then compared against a signal quality
diagram (step 716). This diagram is generated previously, in a
manner described above.
[0064] At step 718, it is determined whether the intermediate data
points fall within the display region. If the answer is yes, the
physiological parameter is estimated based on the detected and
processed signal(s). For example, the oxygen saturation can be
estimated from the computed Mod % for the two LEDs using equation
(5). At step 722, the estimated physiological parameter is
displayed, and the process terminates.
[0065] If it is determined at step 718 that the data points do not
fall within the display region, a determination is made whether the
data points fall within the inactive region (step 724). If the
answer is yes, an error message is displayed at step 726. This
error message may inform the clinician of the error data points
(e.g., "ERROR MEASUREMENT"), provide a suggestion (e.g., "TRY
ANOTHER SITE"), and so on. The process then terminates. In some
embodiments of the invention, step 724 is not performed.
[0066] If it is determined at step 724 that the data points do not
fall within the inactive region, a determination is made whether
the data points fall within the non-display region, at a step 730.
If the answer is yes, the measurement is not displayed. An error
message may be displayed to inform the clinician. This error
message may inform the clinician of the invalid data points (e.g.,
"INVALID MEASUREMENT" or "WEAK SIGNAL"), provide a suggestion
(e.g., "TRY ANOTHER SITE"), and so on. The process then
terminates.
[0067] If it is determined at step 730 that the data points do not
fall within the non-display region, a determination is made whether
the data points fall within the transition region, at step 736. If
the answer is yes, a warning message may be displayed to warn the
clinician. This warning message may indicate that the data points
are of questionable accuracy (e.g., "INACCURATE MEASUREMENT" or
"WEAK SIGNAL"), provide a suggestion (e.g., "TRY ANOTHER SITE"),
and so on. The physiological parameter may also be computed and
displayed along with the warning message. The process then
terminates. In some embodiments of the invention, step 736 is not
performed.
[0068] FIG. 8 shows a signal quality diagram with data collected
from a patient population. The patient data can be used to define
the display and non-display regions, to characterize the patient
population's mean modulation percentage and mean nAv for both red
and infrared wavelengths, to characterize measurement ambiguity
that is indicative of the instrument's accuracy, or a combination
of the above. Ambiguity as used herein, which is an approximate
indication of instrument error, is the sum of the mean error (bias)
of an instrument and the stability of the readings obtained
(wander). The stability of the readings obtained (wander) is the
standard deviation of the instrument readings.
[0069] The ambiguity, or estimated error, for various combinations
of modulation and DC component are then plotted on the signal
quality diagram. The average saturation, saturation bias,
saturation wander, and ambiguity can be computed using equal
weighting (i.e., giving the same importance for each data point) or
unequal weighting that accounts for population statistics (i.e.,
giving less importance to data points that occur more rarely).
Signal specification boundaries can also be obtained for a
particular patient sub-population (e.g., perinatal patients) to
further improve accuracy in the measurement reporting when the
instrument is used for that particular patient sub-population.
[0070] FIG. 9 shows a signal quality diagram that includes
ambiguity contours plotted over a portion of the display region.
Each contour line corresponds to a particular ambiguity, in
saturation points. As an example, at an infrared operating point of
10 nAv and three percent modulation, the plots show an ambiguity of
between 10 and 12 saturation points. The contour lines can be
generated by collecting data points, grouping the data points that
have similar infrared DC components, and selecting a representative
ambiguity for those data points. The selected ambiguities for the
groups of data points are plotted as a two-dimensional contour
plot.
[0071] In an embodiment, the largest ambiguity in each group is
selected as representative of the group and a contour plot of the
worse case ambiguity is generated. This information is useful, for
example, in an oximeter having a guaranteed limit on the saturation
ambiguity, and only data points within the guaranteed limit are
posted. Other variations of the contour plots shown in FIG. 9 are
possible. For example, contour plots can be generated for: (1) the
worst case ambiguity, (2) the average ambiguity, (3) the worst case
or average absolute value of the bias, (4) the worst case or
average value of the wander, and others. The average ambiguity
contour plots are generated based on the average of the ambiguities
obtained for each group, and are useful for indicating typical
ambiguity that is likely to occur for that modulation and infrared
DC component.
[0072] The contour plots on the signal quality diagram can also be
adjusted for, or take into account, different pulse rates and
abnormal heart rhythms such as arrhythmias, premature ventricular
contractions, bigeminy, fibrillation, cardiac arrest, and other
cardiac pathologies.
[0073] The invention provides advantages not available in
conventional oximeters. For example, by detecting data points
corresponding to saturation estimates having a low degree of
confidence and discarding these estimates (or indicating the low
degree of confidence), the invention provides an oximeter having
improved diagnostic accuracy and reliability. This ensures that the
results relied upon by the clinician meet a predetermined
reliability criteria. The invention may also be used to detect and
notify when the sensor has been removed (i.e., fallen off) the
patient, as described above.
[0074] The oximeter of the invention can also be used to assist the
clinician take more accurate measurements. This is a particularly
useful application of the invention since it is known that some
clinicians move the sensor to various parts of the patient in an
attempt to obtain better readings. To assist the clinician, the
oximeter can be programmed to display an indicator signal that
indicates whether a selected site is good or poor for application
of the sensor. This prompt may also be used to assist a less
experienced clinician administer the saturation measurement.
[0075] The invention can be used for various physiological
measurements. The application of the invention to pulse oximetry
has been described as only one preferred embodiment. The invention
can also be applied to other physiological measurements such as
ECG, blood pressure, temperature, heart rate, and so on.
Accordingly, the invention is not to be limited for use only with
oximetry or pulse oximetry.
[0076] The foregoing description of the preferred embodiments is
provided to enable any person skilled in the art to make or use the
present invention. Various modifications to these embodiments will
be readily apparent to those skilled in the art, and the generic
principles defined herein may be applied to other embodiments
without the use of further invention. For example, the invention
can be applied to measurements of other physiological
characteristics. Thus, the present invention is not intended to be
limited to the embodiments shown herein but is to be accorded the
widest scope consistent with the principles and novel features
disclosed herein.
* * * * *