U.S. patent number RE44,187 [Application Number 13/025,124] was granted by the patent office on 2013-04-30 for processing pulse signal in conjunction with accelerometer signal in cardiac resuscitation.
This patent grant is currently assigned to ZOLL Medical Corporation. The grantee listed for this patent is Donald R. Boucher, Frederick Geheb, Alan F. Marcovecchio. Invention is credited to Donald R. Boucher, Frederick Geheb, Alan F. Marcovecchio.
United States Patent |
RE44,187 |
Marcovecchio , et
al. |
April 30, 2013 |
**Please see images for:
( Certificate of Correction ) ** |
Processing pulse signal in conjunction with accelerometer signal in
cardiac resuscitation
Abstract
A cardiac resuscitation device that includes a pulse sensor
configured to detect pulse information characterizing the cardiac
pulse in the patient, an accelerometer configured to detect chest
movements of the patient during chest compressions, and memory and
processing circuits configured to process the outputs of the pulse
sensor and accelerometer to monitor the effect that chest
compressions have on the patient's pulse.
Inventors: |
Marcovecchio; Alan F. (San
Clemente, CA), Geheb; Frederick (Danvers, MA), Boucher;
Donald R. (Andover, MA) |
Applicant: |
Name |
City |
State |
Country |
Type |
Marcovecchio; Alan F.
Geheb; Frederick
Boucher; Donald R. |
San Clemente
Danvers
Andover |
CA
MA
MA |
US
US
US |
|
|
Assignee: |
ZOLL Medical Corporation
(Chelmsford, MA)
|
Family
ID: |
33313120 |
Appl.
No.: |
13/025,124 |
Filed: |
February 10, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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10441933 |
May 20, 2003 |
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10421652 |
Apr 23, 2003 |
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Reissue of: |
11228857 |
Sep 15, 2005 |
7488293 |
Feb 10, 2009 |
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Current U.S.
Class: |
600/504; 600/484;
601/41; 600/587 |
Current CPC
Class: |
A61N
1/3904 (20170801); A61B 5/11 (20130101); A61B
5/0205 (20130101); A61N 1/39044 (20170801); A61B
5/021 (20130101); A61H 31/00 (20130101); A61N
1/3925 (20130101); A61H 31/005 (20130101); A61B
5/024 (20130101) |
Current International
Class: |
A61H
31/00 (20060101) |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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4015038 |
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Jan 1992 |
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JP |
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4028344 |
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Jan 1992 |
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JP |
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4028345 |
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Jan 1992 |
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JP |
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5261071 |
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Oct 1993 |
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JP |
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7265272 |
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Oct 1995 |
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JP |
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95/06525 |
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Mar 1995 |
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WO |
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98/26716 |
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Jun 1998 |
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WO |
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01/22885 |
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Apr 2001 |
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WO |
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Other References
Kassal et al., "Polymer-Based Adherent Differential-Output Sensor
for Cardiac Auscultation," Medical Electronics, vol. 25, No. 4,
Issue 148, pp. 54-63 (Sep. 1994). cited by applicant .
Webster, John G., Medical Instrumentation, Application and Design,
3.sup.rd ed., New York, NY, John J. Wiley & Sons, Inc. 1998.
cited by applicant.
|
Primary Examiner: Schaetzle; Kennedy
Attorney, Agent or Firm: Fish & Richardson P.C.
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a continuation of U.S. patent application Ser.
No. 10/441,933, filed on May 20, 2003, now abandoned, which is a
continuation in part of U.S. patent application Ser. No.
10/421,652, entitled "Optical Pulse Sensor for External
Defibrillator," filed on Apr. 23, 2003, now abandoned.
Claims
What is claimed is:
1. A cardiac resuscitation device, comprising a pulse sensor
configured to detect pulse information characterizing the cardiac
pulse in the patient, wherein the pulse sensor has a pulse sensor
output signal as its output, and wherein the pulse sensor output
signal contains information characterizing individual pulses, each
corresponding to movement of blood in the patient's circulatory
system; an accelerometer configured to detect chest movements of
the patient during a series of individual chest compressions,
wherein the accelerometer has an accelerometer output signal as its
output; and memory and processing circuits configured to process
the pulse sensor output signal in conjunction with the
accelerometer output signal to determine, for each of a plurality
of individual chest compressions in the series of individual chest
compressions, if the individual chest compression actually caused
movement of blood thus resulting in an individual pulse.
2. The device of claim 1 wherein the device comprises a
defibrillator for delivering a defibrillation waveform to the
patient and chest electrodes for detecting at least one LCG signal
on the patient and for delivering a defibrillation waveform to the
patient.
3. The device of claim 2 wherein the memory and processing circuits
are further configured to analyze the pulse sensor output signal in
conjunction with the ECG signal.
4. The device of claim 3 wherein the pulse rate of the pulse signal
is compared to the pulse rate of the ECG signal.
5. The subject matter of claim 2 wherein the defibrillator
comprises an automatic external defibrillator (AED).
6. The subject matter of claim 5 further comprising the capability
to provide the user with prompts for performing CPR, and wherein
the prompts are dependent at least in part on whether the
processing of the pulse signal determines that individual chest
compressions actually cause movements of blood and thus individual
pulses.
7. The device of claim 1 wherein the memory and processing circuits
are configured to process the accelerometer output signal to
determine the rate and depth of delivered individual chest
compressions.
8. The device of claim 1 wherein the memory and processing circuits
are configured to process the pulse sensor output signal to
determine the magnitude and frequency of the patient's pulse.
9. The subject matter of claim 1 wherein the memory and processing
circuits are further configured to determine the efficacy of CPR
treatment of the patient.
.Iadd.10. A cardiac resuscitation device, comprising a pulse sensor
configured to detect pulse information characterizing the cardiac
pulse in the patient, wherein the pulse sensor has a pulse sensor
output signal as its output, and wherein the pulse sensor output
signal contains information characterizing individual pulses, each
corresponding to movement of blood in the patient's circulatory
system; a sensor configured to detect chest movements of the
patient during a series of individual chest compressions, wherein
the sensor has a sensor output signal as its output; and memory and
processing circuits configured to process the pulse sensor output
signal in conjunction with the sensor output signal to determine,
for each of a plurality of individual chest compressions in the
series of individual chest compressions, if the individual chest
compression actually caused movement of blood thus resulting in an
individual pulse..Iaddend.
.Iadd.11. The device of claim 10 wherein the device comprises a
defibrillator for delivering a defibrillation waveform to the
patient and chest electrodes for detecting at least one ECG signal
on the patient and for delivering a defibrillation waveform to the
patient..Iaddend.
.Iadd.12. The device of claim 11 wherein the memory and processing
circuits are further configured to analyze the pulse sensor output
signal in conjunction with the ECG signal..Iaddend.
.Iadd.13. The device of claim 12 wherein the pulse rate of the
pulse signal is compared to the pulse rate of the ECG
signal..Iaddend.
.Iadd.14. The subject matter of claim 11 wherein the defibrillator
comprises an automatic external defibrillator (AED)..Iaddend.
.Iadd.15. The subject matter of claim 14 further comprising the
capability to provide the user with prompts for performing CPR, and
wherein the prompts are dependent at least in part on whether the
processing of the pulse signal determines that individual chest
compressions actually cause movements of blood and thus individual
pulses..Iaddend.
.Iadd.16. The device of claim 10 wherein the memory and processing
circuits are configured to process the sensor output signal to
determine the rate and depth of delivered individual chest
compressions..Iaddend.
.Iadd.17. The device of claim 10 wherein the memory and processing
circuits are configured to process the pulse sensor output signal
to determine the magnitude and frequency of the patient's
pulse..Iaddend.
.Iadd.18. The subject matter of claim 10 wherein the memory and
processing circuits are further configured to determine the
efficacy of CPR treatment of the patient..Iaddend.
Description
TECHNICAL FIELD
This invention relates to pulse sensors and methods of using pulse
sensors in conjunction with external defibrillators.
BACKGROUND
The pulse is a very important parameter that is used to aid users
of automated external defibrillators in determining whether or not
to administer a defibrillation shock to and/or to perform
cardiopulmonary resuscitation (CPR) on a victim who appears to be
in cardiac arrest. Such a victim may actually be in need of cardiac
resuscitation (including defibrillation and/or CPR), or may be
suffering from a condition for which such treatment would be
unsuitable, e.g., a stroke, seizure, diabetic coma, or heat
exhaustion. It is very important to the safety of the victim that
the presence or absence of a pulse be determined quickly and
accurately. However, it is often difficult for trained medical
personnel to take a victim's pulse accurately in the field during a
crisis situation, and may be impossible for a minimally trained or
untrained lay rescuer to do so. In many cases, it will take the
person assisting the victim a considerable time (on the order of
one minute or more) to find the victim's pulse. If a pulse is not
found, the caregiver is left unsure as to whether the victim does
not have a pulse, or whether the caregiver simply cannot find the
victim's pulse.
Another parameter that is used in determining whether to administer
a defibrillation shock is an ECG analysis of the victim's heart
rhythm that is provided by the automated external defibrillator.
Based on the ECG analysis, many automated defibrillators will
provide the user with a message indicating whether a shock should
be administered (i.e., whether or not ventricular fibrillation is
present).
Generally, the ECG analysis systems in most commercially available
automated external defibrillators display only two options to the
user: "Shock Advised" or "No Shock Advised." When "Shock Advised"
is output, this means that the patient is in ventricular
fibrillation or wide complex ventricular tachycardia above 150 BPM,
conditions which are effectively treated by defibrillation. When
"No Shock Advised" is output, this means that the patient's heart
rhythm is not treatable by defibrillation therapy.
If the message indicates that a shock is not appropriate, this does
not necessarily mean that the victim is not in danger. There are
two ECG rhythms, generally referred to as asystole and pulseless
electrical activity, which should not be treated with
defibrillation (and thus will trigger a message not to shock) but
nonetheless are extremely serious in that they suggest that the
patient's heart rhythm is unaccompanied by sufficient cardiac
output (i.e., the patient is close to death). These conditions are
treated by administering cardiopulmonary resuscitation (CPR), in an
effort to provide blood flow to the heart and vital organs in the
hope that with improved blood flow and oxygenation, the heart
muscle will recover from its near death state and possibly begin to
fibrillate again, thus making defibrillation treatment a viable
option.
Thus, when a "No Shock Advised" analysis is output, the caregiver
does not know whether this result is caused by a normal heart
rhythm, an abnormal but perfusing heart rhythm (i.e., the patient
was never in cardiac arrest or the last shock treatment returned
the patient's heart rhythm to normal), or a grossly abnormal
(non-perfusing) ECG rhythm requiring CPR treatment. Because of this
uncertainty, the normal medical protocol when "No Shock Advised" is
output is to check the patient for a pulse and if no pulse is
detected to start CPR. If a pulse is detected, then the patient's
heart is effectively pumping blood and neither CPR nor
defibrillation is warranted. If the victim does not have a pulse,
CPR should be started immediately; if a pulse is present, then CPR
should not be administered. Because CPR, even if properly
administered, can result in broken ribs or other injury to the
victim, it is undesirable to administer CPR if it is not actually
necessary. Thus, it is again vitally important that an accurate
determination of the presence or absence of a pulse be made by the
caregiver.
A similar situation of uncertainty occurs after the third
defibrillation shock is delivered in the three-shock protocol
recommended by the American Heart Association. In this case, if the
patient's fibrillation has not been "cured" after delivery of three
shocks, the caregiver is instructed to perform CPR on the patient.
Because automated external defibrillators generally do not perform
an ECG analysis immediately after the third shock, the caregiver
does not know whether the third shock provided effective treatment.
Therefore, the caregiver must determine whether the patient has a
pulse in order to determine whether CPR is needed or whether the
patient is out of danger.
A wide variety of sensors have been employed for pulse
detection.
Optical sensors have been used in pulse detection. For example,
pulse detectors of the type used for measuring heart rate during
exercise typically rely on reflectance or transmission of an
infrared light beam. Blood pulsing in the user's capillaries
produces a corresponding variation in the absorption of light by
capillaries, and that variation produces a pulsation in the output
of an optical sensor.
Optical sensors are also widely used in pulse oximetry, in which a
measurement is made of the percentage of hemoglobin saturated with
oxygen. An optical plethysmographic probe attached to the patient's
finger or ear lobe generates light at two wavelengths (e.g., 650 nm
and 805 nm). The light is partially absorbed by hemoglobin, by
amounts that differ depending on whether or not the hemoglobin is
saturated with oxygen. By calculating absorption at the two
wavelengths, a pulse oximetry device can compute the proportion of
hemoglobin that is saturated (oxygenated).
Acoustic sensors have also been applied to pulse detection.
Typically, the acoustic sensor is configured to detect sounds
characteristic of a beating heart (e.g., the action of a heart
valve). E.g., Joo U.S. Pat. No. 6,440,082. Some acoustic sensors
used for pulse detection are based on piezoelectric devices.
Another use of a piezoelectric devices in pulse detection is
proposed in U.S. patent application Ser. No. 9/846,673, filed on
May 1, 2001. The piezoelectric device detects motion of the surface
of the body resulting from the pulse (e.g., motion resulting from
blood flowing in a blood vessel beneath the sensor).
SUMMARY
In a first aspect, the invention features a cardiac resuscitation
device, comprising a pulse sensor configured to detect pulse
information characterizing the cardiac pulse in the patient,
wherein the pulse sensor has a pulse sensor output signal as its
output, an accelerometer configured to detect chest movements of
the patient during chest compressions, wherein the accelerometer
has an accelerometer output signal as its output, and memory and
processing circuits configured to process the pulse sensor output
signal and accelerometer output signal to monitor the effect that
chest compressions have on the patient's pulse.
In a second aspect, the memory and processing circuits may be
configured to process the pulse sensor output signal in conjunction
with the accelerometer output signal to provide information to the
user of the device to improve delivery of CPR to the patient.
In a third aspect, the memory and processing circuits may be
configured to process the pulse sensor output signal in conjunction
with the accelerometer output signal to determine if chest
compressions actually result in the movement of blood thus
resulting in a pulse.
In preferred implementations, one or more of the following features
may be incorporated. The device may comprise a defibrillator for
delivering a defibrillation waveform to the patient and chest
electrodes for detecting at least one ECG signal on the patient and
for delivering a defibrillation waveform to the patient. The memory
and processing circuits may be further configured to analyze the
pulse sensor output signal in conjunction with the ECG signal to
determine whether the patient has a pulse. The pulse rate of the
pulse signal may be compared to the pulse rate of the ECG signal.
The memory and processing circuits may be configured to process the
accelerometer output signal to determine the rate and depth of
delivered chest compressions. The memory and processing circuits
may be configured to process the pulse sensor output signal to
determine the magnitude and frequency of the patient's pulse. A
decision whether to deliver a defibrillation waveform to the
patient may be based in part on whether processing of the ECG and
pulse sensor output signals determines that the patient has a
pulse. The defibrillator may comprise an automatic external
defibrillator (AED). The invention may further comprise the
capability to provide the user with prompts for performing CPR, and
wherein the prompts may be dependent at least in part on whether
the processing of the pulse signal determines that the patient has
a pulse. A determination of whether the patient has a pulse may be
undertaken after delivery of the defibrillation waveform, and the
user may be informed of the outcome of the determination. The
memory and processor circuits may be further configured to make a
determination whether to administer CPR to the patient and the
determination may be based at least in part on whether it is
determined that the patient has a pulse. The memory and processing
circuits may be further configured to use the pulse sensor output
signal to determine the efficacy of CPR treatment of the
patient.
In a further aspect, the inventors have found that an external
defibrillator can be configured to determine whether a patient has
a pulse by analyzing the output of a pulse sensor in conjunction
with the patient's ECG signal to determine whether a pulse is
present. In general the invention features applying electrodes to
the chest of the patient, detecting at least one ECG signal from
electrodes, applying a pulse sensor (of varying kinds) to the
patient, detecting a pulse signal from the pulse sensor, and
analyzing the pulse signal in conjunction with the ECG signal to
determine whether the patient has a pulse.
Preferred implementations of this aspect of the invention may
incorporate one or more of the following: The pulse rate of the
pulse signal may be compared to the pulse rate of the ECG signal.
The pulse signal may be processed to isolate the pulsatile
component of the signal. The pulse signal may be examined for a
peak during a window initiated at the occurrence of an R-wave in
the ECG signal. A comparison may be made of the energy in discrete
frequency bands of the pulse and the ECG signals. A peak frequency
corresponding to the peak of one of the pulse and ECG signals may
be determined, and the other of the pulse and ECG signals may be
examined for a peak within a frequency band surrounding the peak
frequency. A frequency domain transformation of the pulse signal
may be processed. The frequency domain transformations of the pulse
and ECG signal may be processed. A decision whether to deliver a
defibrillation waveform to the patient may be based in part on
whether processing of the ECG and pulse signals determines that the
patient has a pulse. The defibrillator may be an automatic external
defibrillator (AED). The implementation may include the capability
to provide the user with prompts for performing CPR, wherein the
prompts are dependent at least in part on whether the processing of
the pulse signal determines that the patient has a pulse. A
determination of whether the patient has a pulse may be undertaken
after delivery of the defibrillation waveform, and the user may be
informed of the outcome of the determination. The pulse sensor
(e.g., an optical plethysmographic sensor) may be mechanically
connected to at least one of the defibrillation electrodes. There
may be two defibrillation electrodes, each supported on a
substrate, and the pulse sensor may be supported on the same
substrate. The wires connected to the pulse sensor may be bundled
with wires connected to the defibrillation electrodes to form a
combined bundle of wires extending from the defibrillator to the
electrodes and sensor. The pulse sensor may be mechanically
separate from the defibrillation electrodes. In the case of an
optical pulse sensor, the sensor may be configured to be attached
to the forehead of the patient to the ear lobe, to the nasal
septum, to the nasal bridge, or to the finger. In the case of an
optical pulse sensor, the sensor may be configured so that its
output may also be used for pulse oximetry, or it may be configured
so that its output is not useful for pulse oximetry. Determining
whether the patient has a pulse may include determining whether the
pulse, if present, is correlated with the R-wave of the patient's
heart rhythm. A determination whether to administer CPR to the
patient may be based on whether it is determined that the patient
has a pulse. The pulse sensor may be to determine the efficacy of
CPR treatment of the patient. Analyzing the pulse signal in
conjunction with the ECG signal may comprise analyzing whether
there is a correlation between the two signals indicative of the
presence of a pulse.
A wide variety of pulse sensors may be used. The pulse sensor may
include a non-optical sensor. The pulse sensor may be an acoustic
(heart sounds) sensor. The pulse sensor may include an ultrasonic
blood flow sensor. The pulse sensor may include a pressure sensor
on a limb-compressing pneumatic cuff. The pulse sensor may include
at least one mechanical or ultrasonic sensor (e.g., a piezoelectric
sensor) configured to detect arterial wall motion caused by blood
flow in an artery. The pulse sensor may include one or more sensors
for measuring body impedance variation from blood flow.
Implementations of the invention have many and various advantages.
They can make it possible to perform a quick and accurate
determination of the appropriate treatment (defibrillation, CPR, or
no cardiac-related treatment) for a patient who appears to be
suffering from cardiac arrest. They can provide an accurate
determination of the presence or absence of a pulse in a patient,
even under adverse conditions, thus significantly reducing the risk
that an inappropriate and even dangerous treatment will be given
erroneously. The accurate pulse determination thus provided
relieves the uncertainty experienced by caregivers in the
circumstances discussed above, and thus increases the likelihood of
the patient receiving prompt, safe and effective treatment. For
example, a pulse sensor can be used to determine whether CPR is
necessary, in the event that an automated defibrillator indicates
that it is not appropriate to shock a patient who appears to be
suffering from cardiac arrest.
In some implementations, in which the pulse sensor is an optical
sensor, the invention provides an optical sensor without the
complexity of pulse oximetry, in which two optical measurements,
one at each of two wavelengths, are made, and complex signal
processing is performed to estimate blood oxygen saturation from
the two measurements.
Other features and advantages of the invention will be apparent
from the drawings, detailed description, and claims.
The details of one or more embodiments of the invention are set
forth in the accompanying drawings and the description below. Other
features, objects, and advantages of the invention will be apparent
from the description and drawings, and from the claims.
DESCRIPTION OF DRAWINGS
FIG. 1 is a diagrammatic, perspective view of an electrode pad with
built-in pulse sensor applied to the chest of patient.
FIGS. 2A-2F are diagrammatic views of other possible pulse sensors
applied to the patient.
FIG. 3A shows an unprocessed pulse signal from a pulse sensor.
FIG. 3B shows a filtered pulse signal, preconditioned for beat
detection.
FIG. 4 is a block diagram of an algorithm used in one
implementation of the invention.
FIG. 5 illustrates how an ECG signal is used in conjunction with
the pulse signal from the pulse sensor.
FIG. 6 is a block diagram of an algorithm for using an ECG signal
in conjunction with the pulse signal.
FIGS. 7 and 8 illustrate other implementations of the invention, in
which the frequency transforms of the ECG and pulse signals are
compared.
FIG. 9 is a table summarizing a decision algorithm used in one
implementation of the invention.
FIG. 10A is a diagrammatic view of a transmittance optical
sensor.
FIG. 10B is a diagrammatic view of a reflectance optical
sensor.
DETAILED DESCRIPTION
There are a great many possible implementations of the invention,
too many to describe herein. Some possible implementations that are
presently preferred are described below. It cannot be emphasized
too strongly, however, that these are descriptions of
implementations of the invention, and not descriptions of the
invention, which is not limited to the detailed implementations
described in this section but is described in broader terms in the
claims.
The descriptions below are more than sufficient for one skilled in
the art to construct the disclosed implementations. Unless
otherwise mentioned, the processes and manufacturing methods
referred to are ones known by those working in the art
FIG. 1 shows a defibrillator 10 connected to a patient 20. Cable 12
connects the defibrillator to an electrode assembly 14, which
supports two chest electrodes 16, 18, an accelerometer 20 (for
measuring chest compression), and a pulse sensor 22 (e.g., an
optical plethysmographic sensor). All wiring for the electrodes,
accelerometer, and pulse sensor are bundled together in cable
12.
FIGS. 2A-2F show alternative locations for the pulse sensor in the
event the sensor is an optical plethysmographic sensor 22 (some of
the same locations may be useful with other types of pulse
sensors): anywhere on the forehead, the bridge of the nose, the
septum of the nose, the ear lobe, the sternum above the
accelerometer, and on any of the fingers or thumb. All of the
sensors shown are commercially available, except the nasal septum
and sternum sensor. The nasal septum sensor would be a
transmittance sensor (e.g., as shown in FIG. 10A), similar to that
available for the ear lobe. The sternum sensor would be a
reflectance sensor (e.g., as shown in FIG. 10B).
The optical plethysmographic sensor 22 detects transmitted or
reflected light, and provides a pulse signal 34, which represents a
parameter correlated with the patient's pulse. In the case of an
optical plethysmographic sensor, the pulse signal 34 would be an
optical signal representing the brightness of light transmitted
through or reflected from a portion of the body through which blood
capillaries extend. The term "pulse signal" is simply a shorthand
for an electrical signal representative of a parameter correlated
with the pulse of the patient. E.g, in the case of an optical
sensor, the pulse signal could be the light sensed by the optical
receiver. If the patient has a pulse, there will generally be a
pulsing variation in the pulse signal. In the case of an optical
sensor, the variation will be in the absorption of light by the
blood capillaries.
A variety of signal processing techniques may be used to process
the pulse signal to determine whether a pulse is present or absent.
Several possibilities are described below. These may be used alone
or in combination.
One processing technique is to process the pulse signal 34 to
isolate any pulsatile component. FIG. 3 shows a typical pulse
signal 34 that would be detected when a pulse is present. A time
domain analysis can be performed on the pulse signal to determine
whether it contains a pulsatile component. For example, the
non-pulsatile component can be estimated as the mean of the pulse
signal, and variation from the mean can be analyzed for the
presence of a pulsatile component indicative of a pulse. The
frequency and strength of the pulsatile component (i.e., the
variation from the mean) can be compared to predetermined frequency
ranges and strength ranges to decide whether a pulse is
present.
The pulse signal may be filtered so that pulses in the waveform are
enhanced and then detected with a beat detection algorithm (e.g.,
the algorithm conventionally utilized for ECG R-wave detection).
The filtering may include a high pass filter, a low pass filter,
and also a notch filter to remove line noise if necessary. The high
pass filter with a -3 dB cutoff frequency near 0.5 Hz removes any
DC component, thus enhancing any existing pulsatile component. The
low pass filter, with a -3 dB point in the range of 5-15 Hz removes
some signal components unrelated to patients' pulse (i.e., noise).
A smoothed or unsmoothed difference operation may also be applied
to the pulse signal as one method to enhance or precondition the
pulse signal for a time-domain beat detection algorithm. FIG. 3A
illustrates a raw pulse signal, and FIG. 3B shows a filtered,
preconditioned pulse signal ready to be processed by a beat
detection algorithm.
The beat detection algorithm of FIG. 4 may be applied to the
preconditioned pulse signal of FIG. 3B. The beat detection
algorithm is intended to identify individual pulses within the
pulse waveform. The arrows at the bottom of FIG. 3B indicate
detection of a beat by the algorithm. Time intervals may then be
computed between any two successive pulse detections. These time
intervals, derived from the pulse waveform, may then by analyzed to
determine the likelihood of a pulse. A moving average of these
intervals may also be computed and updated as new intervals are
measured. If the average interval is within a range (e.g. 35-185
beats/minute), then a pulse might be declared present.
Another processing technique is to use both a pulse signal from the
pulse sensor and an ECG signal from the electrodes. Typically, both
the pulse signal and the ECG signal will exhibit periodicity when a
pulse is present, because a true pulse originates from a
mechanically beating heart, and thus the same periodicity observed
on the pulse signal should be present on the ECG signal when the
heart is beating. However, a periodic ECG signal is not always
indicative of a pulse, and thus should only be used to verify (or
in combination with) periodicity detected in the pulse signal.
FIG. 5 shows an ECG signal 38 in the upper half of the figure and
the filtered, pulsatile component 44 of the pulse signal in the
lower half of the figure. FIG. 6 shows the algorithm followed in
processing the signals. Upon detecting (50 in FIG. 6) an ECG R-wave
(ventricular depolarization) 40 a time window 42 is initiated (52
in FIG. 6). The duration of a time window may change as a function
of the previous ECG cycle length or current average ECG cycle
length. This variable window length is intended to shorten for
shorter cycle lengths (high heart rates) and lengthen for longer
cycle lengths (lower heart rates). During that time window, the
pulsatile component 44 of the pulse signal is analyzed for a
corresponding pulse (54 in FIG. 6). The pulse signal is not
analyzed outside of this time window, thereby reducing the number
of false detections on the pulse signal. Alternatively, the entire
pulse signal is analyzed and pulse detects outside of an R-wave
initiated time window are ignored. Detection of a pulse on the
pulse signal within the time window could be sufficient to conclude
that a pulse is present. Greater confidence that a pulse is present
can be had using a confidence index that is increased each time a
pulse is detected in the pulse signal during the prescribed time
window following an R-wave. In FIG. 5, all of the pulse pulses,
except the seventh pulse 46, are detected and considered as valid
detects since they are within time windows initiated by R-wave
detections on the ECG signal. The portion of the pulse waveform
comprising the seventh pulse 46 is either not analyzed or detected
and ignored since it is outside of an pulse detect time window. One
possible confidence index would be the percentage of instances in
which a pulse is detected in a window following detection of an
R-wave. If the confidence index exceeds an empirically determined
threshold, the existence of a pulse is declared. Otherwise a pulse
is considered to be absent.
A simpler technique is to determine the pulse rate of each of the
ECG and pulse signals, and simply compare the two pulse rates. If
the difference between the two rates is within a range (e.g., 1-5
beats/minute), the existence of a pulse is declared. This technique
may be used in conjunction with the pulse windowing scheme to
minimize the number of false positive detections on the pulse
signal. If the implementation does not employ a method (e.g.,
windowing scheme) to minimize false positive detections on the
pulse signal, then the comparison between pulse and ECG derived
pulse rates may be modified. In this case the absence of a pulse
would be declared if the pulse rate is less than the ECG rate. This
modification takes into consideration that the pulse rate may be
higher than the ECG rate due to false pulse detections, and such a
condition may be indicative of a pulse despite the difference
between the two rates being outside of a range.
Another technique is to compare band-limited versions of the ECG
and pulse signals. The signals can be band limited over a range of
likely pulse frequencies (e.g., 0.5-5 Hz). The band-limited signals
are compared to determine if a pulse or peak frequency of the pulse
signal compares well with a pulse or peak frequency of the ECG
signal. If the two compare well, the existence of a patient pulse
is supported. Comparisons can be made using several different
quantitative techniques. Cross correlation (convolution) of the two
filtered waveforms is one technique that can be used to quantify
the comparison of the two waveforms.
One technique for comparing the peak frequencies of the two signals
is shown in FIG. 7. Each of the ECG and pulse signals is
transformed into a frequency domain using, e.g., an FFT, wavelet,
or other transform. The frequency peak of the transformed pulse
signal is then compared with the ECG derived heart rate or peak
frequency. An association between the two frequency peaks supports
the existence of a pulse. A quantitative technique for determining
how well the two frequency peaks compare is suggested in FIG. 7.
The energy levels in discrete frequency bands are compared, e.g.,
the a-b band 60 in the ECG transform is compared to the a-b band 62
in the pulse signal transform.
The peak frequencies can also be compared by examining one signal
for a peak located within a predetermined frequency band centered
on the peak frequency of the other signal. For example, as shown in
FIG. 8, the peak ECG frequency 70 could be measured and updated at
regular intervals (which could be constant or variable as a
function of heart rate), with the measurement being done either in
the time domain or in a transformed frequency domain. The pulse
signal 74 would then be examined for a corresponding peak frequency
within a band 72 centered on the continuously updated peak ECG
frequency (e.g., using an adaptive filter). The existence of a peak
on the pulse signal within the ECG determined band supports the
existence of a pulse. In FIG. 8, the peak in the pulse signal is
outside the band, thus suggesting that a pulse is not present.
The autocorrelation of the ECG signal can also be compared with the
autocorrelation of the pulse signal. Comparing autocorrelation
signals improves the signal to noise ratio and may be particularly
useful if the periodic component of the signals is small. The two
autocorrelation signals may be compared using a cross-coeerlation.
The comparison determines if the periodicity of the two
autocorrelated signals are similar. Similar periodicities support
the existence of a pulse.
The addition of a pulse detection system adds significant
improvements to automatic and semi-automatic external
defibrillators. The addition of a pulse detection system will
reduce the number of inappropriate shock advisements. Particularly
in cases where patients have a pulse, but have been incorrectly
classified by the ECG analysis algorithm as having a shockable
rhythm. As shown in the table of FIG. 9, the addition of the pulse
detection system will override the shock advisement from the ECG
analysis algorithm thereby appropriately inhibiting defibrillation
therapy. The addition of a pulse detection system will also enable
the defibrillator to advise the rescuer when CPR is appropriate and
inappropriate. In the case where the ECG analysis algorithm advises
"No Shock" and the pulse detection algorithm indicates "No Pulse",
the defibrillator may indicate to the rescuer that CPR should be
administered. Conversely, detection of a pulse by the pulse
detection system may be used to indicate to the rescuer that CPR is
no longer necessary.
The pulse detection system may also be used to improve the
defibrillator system by providing feedback to the rescuer during
the administration of CPR. In this scenario, the pulse detection
system may be utilized to monitor the effect that chest
compressions have on a patients pulse. The detected magnitude and
frequency of a pulse by the pulse detection system may be used
independently or in conjunction with accelerometer data to aid the
rescuer in delivering optimal CPR to the victim. Whereas an
accelerometer may be used to measure the rate and depth of
delivered chest compressions, a pulse detection system may be used
to determine if these chest compressions actually result in the
movement of blood thus resulting in a pulse.
A wide variety of pulse sensors may be used. For example, the
sensor could be optical or non-optical. It could include an
acoustic sensor (e.g., amplified stethoscope signals) for detecting
heart sounds characteristic of a beating heart. It could include a
sensor capable of mechanical or ultrasonic measurement (e.g.,
piezoelectric) of arterial wall motion--e.g., in locations such as
the neck (carotid arteries), arms (radial and brachial arteries),
and legs (femoral artery) where the arteries are relatively close
to the surface. It could include an ultrasonic measurement of blood
flow (e.g., such as the ultrasonic blood flow detectors used to
detect carotid and/or femoral artery stenosis). It could include a
pressure sensor that measures variation in the pressure in a
limb-compressing pneumatic cuff. The sensor could employ impedance
techniques for monitoring blood flow into and out of an arterial
bed, e.g., as now used to non-invasively measure pulsatile cardiac
output by measuring impedance across the chest. The same approach
could be applied to other part of the body where pulsatile blood
flow exists.
Both invasive (e.g., direct measurements of a parameter) and
non-invasive (indirect measurements of a parameter) sensors can be
used The examples given above are generally non-invasive. But
invasive sensors could also be used, including, for example,
pressure sensors coupled to a patient's vascular pressure via a
liquid filled catheter, or intravascular pressure sensors, in which
the sensor is incorporated onto the tip of a catheter placed in the
vascular system.
Many other implementations of the invention other than those
described above are within the invention, which is defined by the
following claims.
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