U.S. patent application number 17/234425 was filed with the patent office on 2021-08-05 for devices and methods for monitoring physiologic parameters.
This patent application is currently assigned to Respirix, Inc.. The applicant listed for this patent is Respirix, Inc.. Invention is credited to Stephen BOYD, Daniel R. BURNETT, Evan S. LUXON.
Application Number | 20210236004 17/234425 |
Document ID | / |
Family ID | 1000005524987 |
Filed Date | 2021-08-05 |
United States Patent
Application |
20210236004 |
Kind Code |
A1 |
LUXON; Evan S. ; et
al. |
August 5, 2021 |
DEVICES AND METHODS FOR MONITORING PHYSIOLOGIC PARAMETERS
Abstract
Devices and methods for monitoring physiologic parameters are
described herein which may utilize a non-invasive respiratory
monitor to detect minor variations in expiratory airflow pressure
known as cardiogenic oscillations which are generated by changes in
the pulmonary blood volume that correspond with the cardiac cycle.
These cardiogenic oscillations are a direct indicator of cardiac
function and may be used to correlate various physiologic
parameters such as stroke volume, pulmonary artery pressure,
etc.
Inventors: |
LUXON; Evan S.; (Omaha,
NE) ; BURNETT; Daniel R.; (San Francisco, CA)
; BOYD; Stephen; (San Francisco, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Respirix, Inc. |
San Francisco |
CA |
US |
|
|
Assignee: |
Respirix, Inc.
San Francisco
CA
|
Family ID: |
1000005524987 |
Appl. No.: |
17/234425 |
Filed: |
April 19, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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17158660 |
Jan 26, 2021 |
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17234425 |
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15582227 |
Apr 28, 2017 |
10932674 |
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17158660 |
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PCT/US2015/059608 |
Nov 6, 2015 |
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15582227 |
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62076603 |
Nov 7, 2014 |
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62107443 |
Jan 25, 2015 |
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62145919 |
Apr 10, 2015 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 5/7278 20130101;
A61B 5/4875 20130101; A61B 5/024 20130101; A61B 5/0816 20130101;
A61B 5/029 20130101; A61B 5/02007 20130101; A61B 5/02405 20130101;
A61B 5/0878 20130101; A61B 5/0205 20130101; A61B 5/091 20130101;
A61B 5/087 20130101; A61B 5/318 20210101; A61B 5/7246 20130101;
A61B 5/082 20130101; A61B 5/486 20130101; A61B 5/097 20130101; A61B
5/021 20130101; A61B 5/682 20130101; A61B 5/0002 20130101; A61B
5/02055 20130101 |
International
Class: |
A61B 5/0205 20060101
A61B005/0205; A61B 5/024 20060101 A61B005/024; A61B 5/00 20060101
A61B005/00; A61B 5/029 20060101 A61B005/029; A61B 5/087 20060101
A61B005/087; A61B 5/318 20060101 A61B005/318; A61B 5/021 20060101
A61B005/021; A61B 5/02 20060101 A61B005/02 |
Claims
1. An apparatus which is sized to be held by a subject for
measuring one or more physiologic parameters of the subject,
comprising: a mouthpiece having an ECG sensor, wherein the
mouthpiece is sized to be enveloped by a mouth of the subject such
that the ECG sensor contacts a lip of the subject when in use, and
wherein the mouthpiece defines an airway lumen therethrough; a
controller in communication with the ECG sensor, wherein the
controller is configured to measure one or more physiologic
parameters of the subject via the ECG sensor and determine a health
condition of the subject.
2. The apparatus of claim 1 further comprising a second sensor in
communication with the controller.
3. The apparatus of claim 2 wherein the second sensor is configured
to sense a pO2level of the subject.
4. The apparatus of claim 2 wherein the second sensor is configured
to sense a temperature of the subject.
5. The apparatus of claim 2 wherein the second sensor is configured
to sense a respiration rate of the subject.
6. The apparatus of claim 2 wherein the second sensor is configured
to sense a heart rate of the subject.
7. The apparatus of claim 3 wherein the controller is configured to
determine a heart rate variability of the subject.
8. The apparatus of claim 2 wherein the second sensor is configured
to sense a blood pressure of the subject.
9. The apparatus of claim 2 wherein the second sensor is configured
to sense a respiration pattern of the subject.
10. The apparatus of claim 2 wherein the second sensor is
configured to sense a spirometry lung function of the subject.
11. The apparatus of claim 1 further comprising one or more
additional sensors in communication with the controller, wherein
the one or more additional sensors is configured to sense at least
five physiologic parameters selected from the group consisting of
pO2level, temperature, respiration rate, heart rate, heart rate
variability, blood pressure, respiration pattern, and spirometry
lung function.
12. The apparatus of claim 1 further comprising one or more
additional sensors in communication with the controller, wherein
the one or more additional sensors is configured to sense at least
six physiologic parameters selected from the group consisting of
pO2 level, temperature, respiration rate, heart rate, heart rate
variability, blood pressure, respiration pattern, and spirometry
lung function.
13. The apparatus of claim 1 further comprising one or more
additional sensors in communication with the controller, wherein
the one or more additional sensors is configured to sense at least
seven physiologic parameters selected from the group consisting of
pO2 level, temperature, respiration rate, heart rate, heart rate
variability, blood pressure, respiration pattern, and spirometry
lung function.
14. The apparatus of claim 1 further comprising one or more
additional sensors in communication with the controller, wherein
the one or more additional sensors is configured to sense
physiologic parameters comprising pO2 level, temperature,
respiration rate, heart rate, heart rate variability, blood
pressure, respiration pattern, and spirometry lung function.
15. The apparatus of claim 1 wherein the controller is programmed
to determine a sufficiency of the one or more physiologic
parameters for determining the health condition and to further
prompt the subject when the one or more physiologic parameters are
inadequate for analysis.
16. The apparatus of claim 1 wherein the controller is programmed
to prompt the subject to hold a breath for a period of time.
17. The apparatus of claim 1 further comprising a microphone for
detecting a respiratory sound of the subject, wherein the
microphone is in communication with the controller.
18. A method for measuring one or more physiologic parameters of a
subject, comprising: sensing one or more physiologic parameters
from an ECG sensor positioned on a mouthpiece such that the ECG
sensor contacts the subject when the mouthpiece is enveloped by a
mouth of the subject, and wherein the mouthpiece defines an airway
lumen therethrough; receiving the one or more physiologic
parameters via a controller in communication with the ECG sensor;
and determining a health condition of the subject based on the one
or more physiologic parameters and via the controller.
19. The method of claim 18 further comprising sensing a second
physiologic parameter via a second sensor in communication with the
controller.
20. The method of claim 19 wherein sensing the second physiologic
parameter comprises sensing a pO2 level of the subject.
21. The method of claim 19 wherein sensing the second physiologic
parameter comprises sensing a temperature of the subject.
22. The method of claim 19 wherein sensing the second physiologic
parameter comprises sensing a respiration rate of the subject.
23. The method of claim 19 wherein sensing the second physiologic
parameter comprises sensing a heart rate of the subject.
24. The method of claim 20 wherein sensing the second physiologic
parameter comprises determining a heart rate variability of the
subject.
25. The method of claim 19 wherein sensing the second physiologic
parameter comprises sensing a blood pressure of the subject.
26. The method of claim 19 wherein sensing the second physiologic
parameter comprises sensing a respiration pattern of the
subject.
27. The method of claim 19 wherein sensing the second physiologic
parameter comprises sensing a spirometry lung function of the
subject.
28. The method of claim 18 further comprising sensing one or more
additional physiologic parameters via one or more additional
sensors in communication with the controller, wherein the one or
more additional sensor is configured to sense at least five
physiologic parameters selected from the group consisting of pO2
level, temperature, respiration rate, heart rate, heart rate
variability, blood pressure, respiration pattern, and spirometry
lung function.
29. The method of claim 18 further comprising sensing one or more
additional physiologic parameters via one or more additional
sensors in communication with the controller, wherein the one or
more additional sensor is configured to sense at least six
physiologic parameters selected from the group consisting of pO2
level, temperature, respiration rate, heart rate, heart rate
variability, blood pressure, respiration pattern, and spirometry
lung function.
30. The method of claim 18 further comprising sensing one or more
additional physiologic parameters via one or more additional
sensors in communication with the controller, wherein the one or
more additional sensor is configured to sense at least seven
physiologic parameters selected from the group consisting of pO2
level, temperature, respiration rate, heart rate, heart rate
variability, blood pressure, respiration pattern, and spirometry
lung function.
31. The method of claim 18 further comprising sensing one or more
additional physiologic parameters via one or more additional
sensors in communication with the controller, wherein the one or
more additional sensor is configured to sense physiologic
parameters comprising pO2 level, temperature, respiration rate,
heart rate, heart rate variability, blood pressure, respiration
pattern, and spirometry lung function.
32. The method of claim 18 wherein determining the health condition
of the subject comprises determining a sufficiency of the one or
more physiologic parameters for determining the health condition
and prompting the subject when the one or more physiologic
parameters are inadequate for analysis.
33. The method of claim 18 further comprising prompting the subject
to hold a breath for a period of time.
34. The method of claim 18 further comprising detecting a
respiratory sound of the subject via a microphone which is in
communication with the controller.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is continuation of U.S. patent application
Ser. No. 17/158,660 filed Jan. 26, 2021, which is a continuation of
U.S. patent application Ser. No. 15/582,227 filed Apr. 28, 2017,
which is a continuation of International Application No.
PCT/US2015/059608 filed Nov. 6, 2015, which claims the benefit of
priority to U.S. Provisional Application No. 62/076,603 filed Nov.
7, 2014 and U.S. Provisional Application No. 62/107,443 filed Jan.
25, 2015 and U.S. Provisional Application No. 62/145,919 filed Apr.
10, 2015, each of which is incorporated herein by reference in its
entirety.
FIELD OF THE INVENTION
[0002] The present invention relates to the field of monitoring
cardiac function.
[0003] INCORPORATION BY REFERENCE
[0004] All publications and patent applications mentioned in this
specification are herein incorporated by reference to the same
extent as if each such individual publication or patent application
were specifically and individually indicated to be so incorporated
by reference.
BACKGROUND OF THE INVENTION
[0005] Heart failure (HF) is the leading cause of hospitalization
among adults over 65 years of age in the United States. In 2014,
more than 5.1 million people in the United States were living with
a diagnosis of HF, and as many as one in nine deaths each year can
be attributed to complications stemming from this disease. Acute
decompensation is a life-threatening consequence of HF that occurs
when uncontrolled fluid retention in the thoracic cavity prevents
the heart from maintaining adequate circulation. An important
component of managing HF patients is maintaining an appropriate
fluid volume by adjusting the patient's medications in response to
his/her cardiac function. Fluid volume metrics, such as dyspnea,
edema, and weight gain, can be monitored by patients at home as an
indirect indicator of worsening cardiac function, but are highly
non-specific and cannot predict decompensation risk with sufficient
resolution to affect the hospitalization rate. Recent evidence has
shown that directly monitoring cardiac function via an implantable
sensor can provide clinicians with a remote monitoring tool to
determine when medication adjustments can prevent decompensation
and the need for hospitalization. However, the cost and invasive
nature of these sensors severely restrict their potential for
clinical adoption.
[0006] Various mechanisms have been employed to determine cardiac
function and health. These include invasive technologies such as
the Swan Ganz catheter and a pulmonary artery implant to less
invasive technologies such as arterial waveform monitoring devices,
and surface worn technologies such as bioimpedance monitors and
noncontact technologies such as scales to monitor weight. The
invasive technologies are more accurate but also more risky while
the noninvasive technologies have less risk but are more cumbersome
and typically less accurate. The presence of collected fluid,
peripheral edema, ascites, pleural effusions and weight can also be
used to monitor cardiac function in CHF patients, but these
parameters are merely symptomatic surrogates with poor correlation
to actual cardiac output.
[0007] What is needed is a simple, repeatable, accurate monitor of
cardiac function and other physiologic parameters that allows
consistent measurement of cardiac output in the clinic, hospital
and/or home environment. The present invention provides an easy to
use, home-based device and method for the tracking of cardiac
output, stroke volume and cardiac function. The invention can also
be used for monitoring mechanical phases of the cardiac cycle,
which are useful for diagnosing structural issues such as heart
valve pathologies.
SUMMARY OF THE INVENTION
[0008] The present invention is a non-invasive respiratory monitor
that is capable of directly monitoring cardiac function in a remote
setting. The respiratory monitor, or airway device/controller,
detects minor variations in expiratory airflow pressure known as
cardiogenic oscillations, which are generated by changes in the
pulmonary blood volume that correspond with the cardiac cycle. The
strength, or magnitude, of cardiac oscillations is a direct
indicator of cardiac function and is directly correlated with
stroke volume and inversely proportional to pulmonary artery
pressure.
[0009] In one example of a system which may be used for determining
one or more physiologic parameters of a subject, the system may
generally comprise a flow or pressure sensor configured to monitor
respiratory activity of the subject, a controller in communication
with the flow or pressure sensor, wherein the controller is
programmed to: extract one or more cardiogenic oscillation
waveforms from the respiratory activity, determine shape data of
the cardiogenic oscillation waveforms to determine one or more
physiologic parameters of the subject, provide an indication of a
health status of the subject, and prompt the subject to actively
modify their respiratory activity, if needed, to reduce or enhance
an effect of respiratory activity on the cardiogenic oscillation
waveforms.
[0010] In use, one example of how such a system may be used for
determining one or more physiologic parameters of a subject may
generally comprise receiving flow or pressure data related to
respiratory activity of the subject, extracting one or more
cardiogenic oscillation waveforms from the flow or pressure data,
determining shape data of the one or more cardiogenic oscillation
waveforms, determining one or more physiologic parameters based on
the determined shape data, providing a health status to the subject
based on the determined one or more physiologic parameters, and
prompting the subject to actively modify their respiratory
activity, if needed, to reduce or enhance an effect of respiratory
activity on the cardiogenic oscillation waveforms.
[0011] Minor, cyclic waveforms caused by cardiogenic oscillations,
or cardiac pulses, can be detected in the bulk pressure and flow
measurements of expiration and inspiration. The method and device
of the present invention utilizes this ability to detect and
isolate cardiac oscillations, or pulsations, within the sensed
pressure profile in the airway of an animal or human. Pressure
measured at around 100 Hz, or around 80Hz to around 120 Hz, within
the airway of a subject allows for excellent resolution of the
pressure signal. When pressure in the airway is measured at this
frequency, cardiogenic oscillations may be visible in the resulting
pressure curve. These pulsations are best seen at end expiration,
or during a breath hold, but can be seen throughout the breathing
cycle. This result may be the result of the heart beating in close
proximity to the lungs, which subsequently transmits the pressure
fluctuations through the trachea to the mouth and nose. It may also
be the result of pulmonary blood flow, which may slightly compress
the lungs as the heart beats.
[0012] Cardiogenic oscillations also occur in other measurements of
the breath, such as CO2 concentration and temperature. Although the
preferred embodiment makes use of pressure and flow measurements,
the same analyses and diagnoses described herein may be made using
cardiogenic oscillations in other parameters.
[0013] The magnitude of cardiac oscillations may be indicated by
the standard deviation, or variations, of the cardiac oscillation
pressure waveform and is a direct indicator of cardiac function and
is directly correlated with stroke volume and inversely
proportional to pulmonary artery pressure. The magnitude of cardiac
oscillations may also be indicated by the peak-to-peak amplitude or
the area under the curve of the waveform. The cardiac performance
of patients with heart failure is reduced when compared to that of
healthy individuals, which will dampen the cardiac oscillation
curve relative to healthy subjects.
[0014] The present invention senses pressure and/or flow within the
airway by exposing the airway (via the patient's nose or mouth) to
one or more pressure, flow, and/or other sensor(s). When the
epiglottis is opened, this exposure to the airway allows pressure
and/or flow sensors to detect small pulsations that occur during
heart function. These fluctuations may also be detected with a
sensitive enough sensor, when the epiglottis is closed. With an
appropriately sensitive sensor sampling at a rapid frequency,
waveforms can be seen in the airway corresponding to contractions,
relaxation and valve openings in the heart. This phenomenon has
been found to be repeatable and allows not only for tracking of
heart and lung function and/or conditions (i.e. pulmonary edema,
pleural effusions, congestive heart failure, aortic insufficiency,
mitral, pulmonic, tricuspid insufficiency, etc.) but can be used to
diagnose disease in patients using the airway device. Whereas ECG
is used to monitor and diagnosis heart conditions based on the
electrical signal being sent to the heart, the present invention
provides additional information based on the actual mechanical
function of the heart.
[0015] Preferably, the amplitude and/or area under the curves for
pressure and flow data can be used to determine relative pulmonary
blood flow, relative stroke volume, and/or relative pulmonary
artery pressure. For example, as pulmonary blood flow increases,
the amplitudes of the flow pulsations in the breath increase.
Additional parameters, such as the slope of the pressure curve,
changes in the curve or standard deviation of the curve can also be
used to determine relative cardiac function. When tracked over
time, these parameters provide noninvasive insights into the
patient's changing cardiac health and can be used to adjust his/her
care accordingly. This is particularly useful for people who are
being monitored regularly for changes in their conditions, such as
patients with heart failure. Patient pressure/flow curve data can
also be compared to those of healthy or unhealthy patient
populations to assess a particular patient's, or a group of
patients', health
[0016] In its preferred embodiment the patient is prompted by a
controller to breathe into the device naturally for several cycles.
This may be done automatically by a controller. Further, the airway
device may be simply placed in the mouth and worn while going about
activities of daily living to allow for natural sensing of
respiratory rate, another powerful predictor and indicator of
progressing illness. In some embodiments, the airway
device/controller can calculate the rate of exhalation and capture
cardiogenic oscillations at the same phase of breathing for each
patient to allow for consistent measures of cardiac output and lung
function. In other embodiments, the mean or median of the samples
may be used as the representative value for that particular
measurement. For example, the patient may breath regularly for 2,
5, or 10 minutes, during which the pressure, flow, and other
signals are captured, and at the end the of the session values such
as the average amplitude of the signal caused by cardiogenic
oscillations may be reported. In this way intra-measurement
variability is reduced and the signal-to-noise ratio is
improved.
[0017] Further, in some embodiments, the patient may be prompted by
a controller to inhale deeply and hold his/her breath (or, if used
in conjunction with a ventilator, the ventilator can be paused at
end inhalation, end exhalation, or elsewhere, either manually or,
preferably, automatically with communication between airway
device/controller and the ventilator or incorporation of airway
device/controller into the ventilator) to see the impact of
breathing on the pressure waveform. Variability in the respiratory
pulse pressure waveform can be used to determine hydration status,
as well as volume status. Dehydrated or hypovolemic patients will
see a pulse pressure waveform that varies throughout the
respiratory cycle due to the change in cardiac function with the
changing thoracic pressures found with respiration. As fluid status
is restored, this variability is reduced and lack of variability
can provide a powerful indicator that fluid status has been
restored. In addition to pulse pressure variability, heart rate
variability may also be used to assess fluid status. Variability
may be assessed on a continuous basis during natural or mechanical
ventilation or may be assessed during a respirator pause to look
for changes at end-inspiration and/or end-expiration over time to
track variability. The ratio of end-inspiratory to end-expiratory
pulse amplitude during respiration or with a breath hold may be
determined. Variations in waveform peak-to-peak period and
magnitude, in addition to other parameters, may be determined.
[0018] A respiratory pause may also be used to provide another
determinant of cardiac output-change in end-tidal CO2 after a
respirator pause. The use of respiratory pulse pressure waveform
analysis in conjunction with the end tidal CO2 method may improve
the accuracy of the results and make this method less susceptible
to pulse pressure variability.
[0019] In addition, actual, or absolute, cardiac output can be
determined without calibration using the airway device/controller.
By combining the airway device/controller with spirometry or a
ventilator, the volume of air in the lung can be accurately
estimated. In addition, actual, or absolute, cardiac output can be
determined using a CO2 sensor to determine end tidal CO2, as well
as an air flow sensor and oxygen sensor. The calculations to
determine cardiac output can be performed as described in
"Noninvasive Monitoring Cardiac Output Using Partial CO2
Rebreathing" by Brian P. Young, MD, and Lewis L. Low, MD. A
spirometer and/or ventilator may be stationary or ambulatory, or
may be miniature and built into the mouthpiece itself.
[0020] In another embodiment, absolute stroke volume, cardiac
output, and/or pulmonary artery pressure can be estimated by
comparing the amplitude of the pressure or flow curves in the
airway to the volume of air in the lungs and using correlation
coefficients based on patient based variables such as their gender
and height, in a similar manner to the way correlation coefficients
can be use with pulse-transit-time to estimate blood pressure (see
Gesche, Heiko, et al. "Continuous blood pressure measurement by
using the pulse transit time: comparison to a cuff-based method."
(2011)). In this manner, the present invention may be used to
estimate the actual volume displaced in the lung by the cardiac
pulse, which represents the true stroke volume. An ECG or pulse
oximetry signal may be used to help determine the pulse transit
time.
[0021] Furthermore, in the setting of low pulse pressure
variability this technique can also be used to calculate the dead
space in the lung. This can be done by comparing the cardiac pulse
pressure waveform at end-inhalation and end-exhalation. If tidal
volume is known (i.e. with spirometry or mechanical ventilation),
then, assuming the cardiac pulse is a constant, one can calculate
the dead space in the lung by looking at the magnitude of the
cardiac pressure pulse and calculating the predicted amplitude of
the cardiac pulse, measuring the actual amplitude of the cardiac
pulse, and determining the dead space information from the
difference between the two (due to the extra dead space being
compressed also). Total lung volume may also be calculated by the
application of a fixed amount of analyte or a small bolus of
gas/air to the lung then calculating the resulting concentration of
the analyte or the final pressure after delivery of the bolus of
air (assuming a breath hold at end-inspiration).
[0022] Due to its ease of use and non-invasive nature, the present
invention lends itself well to home healthcare monitoring. In a
preferred embodiment, the airway device will be handheld or body
worn (but does not need to be). The airway device may continuously
or intermittently measure flow rates/volumes, pressure,
temperature, and/or gas concentrations in the airway. Patient
manipulations may be requested by the airway device/controller
(i.e. "Breathe deep then hold your breath for 5 seconds") and the
airway device/controller may be able to automatically or manually
communicate the extracted information to the patient and/or
healthcare provider, or with a mobile device, computer, server or
other device. Alerts may be programmed into the airway device
and/or controller, as well, to warn of impending issues or danger,
or to guide the user through its use. By continuously sensing the
pressure, the airway device/controller may also provide continuous
feedback on the adequacy of the patient manipulations (i.e. "Slow
down the speed of your breath") to optimize the patient
manipulations for improved data capture. Feedback and alerts may be
audible, visual, vibration, etc. Alerts may also be sent to a
physician, monitor, hospital, EMR etc. Alerts may be transferred
wirelessly to any device including a mobile device, computer,
server, etc.
[0023] In temperature-sensing embodiments, the airway
device/controller may sense inhaled and exhaled temperature and the
controller, based on flow/heat exchange algorithms, reports the
patient's temperature. Alternatively, the airway device/controller
may report trends in temperature based on baseline data acquired
when the patient was at a normal temperature. This deviation from
baseline data can be utilized with any of the sensed parameters
thereby allowing for the determination of a relative change in any
of the parameters without knowing the actual value of any of the
parameters.
[0024] In any of the home health, clinic or hospital embodiment of
the airway device/controller of present invention, additional
functionality may be incorporated, including temperature sensing,
respiratory function monitoring (i.e. spirometry), acoustic
monitoring (to track wheezing in asthmatics, etc.), detection of
analytes and/or compounds in the breath (i.e. urea, markers of
infection, O2, CO2, water vapor, etc.), detection of analytes in
the saliva (since the device may be placed inside the mouth in some
embodiments). Additional air sensors may include alcohol, and/or
other drugs such as narcotics, marijuana, tobacco, etc.
[0025] In addition, physical sensors in contact with the body, for
example the lips, may include ECG sensors, pulse sensors, mucosal
contact sensors, etc. When ECG sensors are in place, sampling of
the pulsatile signals in the breath from the cardiogenic
oscillations may be syncronized with the ECG signal in order to
identify periodic signals, evaluate only the relevant portions of
the signal and to reduce the amount of noise. For example, the
magnitude of change in the pressure and/or flow signals during a
set amount of time (such as 200 or 500 ms) may be the variable of
interest that is tracked over time to monitor the cardiac health of
the patient. A 2-lead ECG may also be used. The R wave, of the ECG
signal may be used for synchronization. Pulse oximetry may also be
used.
[0026] The amplitude of cardiac oscillations is directly affected
by pulmonary blood flow (PBF) in a linear manner, and the amplitude
of this cardiac oscillation peak is likely correlated to the
pulmonary blood volume variation (PBVV), which is defined as the
change in the pulmonary blood volume from systole to diastole. PBVV
has previously been investigated as a metric of cardiac function
during heart failure. The PBVV reflects an increase in capillary
volume that impinges upon the compliant bronchiole network leading
to the alveoli of the lung and generates high frequency peaks in
airway pressure during systole phase of the cardiac cycle. These
peaks of cardiac oscillations can be detected. PBVV is proportional
to the stroke volume and both values decrease as the cardiac output
declines during heart failure. PBVV is also inversely proportional
to increases in vascular resistance coincident with heart failure,
which restrict the ability of the pulmonary capillaries to expand
into the pulmonary airways and contribute to pulmonary
hypertension. Thus, the standard deviation of cardiac oscillations
(SDCOS) is directly proportional to cardiac output and inversely
proportional to pulmonary artery pressure (PAP):
SDCOS.varies.a*(-.DELTA.PAP)+b*.DELTA.PBF
[0027] where a and b are constants representing compliance of the
pulmonary arteries and bronchioles, respectively.
Pulmonary Arterial Compliance
[0028] Pulmonary Arterial Compliance (PAC) is related to Cardiac
Heart Failure (CHF) and is a strong indicator of CHF. As the
pulmonary artery becomes congested, PAP increases, as PAP
increases, the pulmonary artery stretches. But, at higher pressures
(above about 25 mmHg), the pulmonary artery becomes less able to
stretch further which leads to increased pulse pressure within the
pulmonary artery (pulmonary artery pulse pressure, or PAPP). As a
result of the higher pressures within the pulmonary artery, more
work is required from the right ventricle, and stroke volume (SV)
is increased.
[0029] PAC can be calculated as SV/PAPP (mL/mmHg)
[0030] Pulmonary arterial compliance has been shown to be a strong
indicator of cardiovascular death or complications. As PAC
decreases, the chance of cardiovascular complications or death
increases. In addition, treatments for heart failure have been
shown to increase the PAC. Currently, the only reliable way to
measure PAC is with an invasive catheterization procedure.
[0031] Cardiogenic oscillations are generated by the cardiac
pulsation in the pulmonary vasculature and are directly related to
PAC. As heart failure worsens, stroke volume may decrease which
leads to a decrease in the PAC amplitude. Also, PAP increases, the
pulmonary artery stiffens, and PAPP increases, also leading to a
decrease in the PAC amplitude. A decrease in PAC or PAC amplitude,
is a strong indicator of worsening heart health. Amplitude in this
instance refers to peak-to-peak amplitude of the curve.
[0032] In one use case example, the airway device/controller can be
used to track a patient with congestive heart failure. If the
patient using the airway device/controller is found to have
decreased stoke volume or increased pulmonary artery pressure (via
the pressure and/or flow sensors), decreased lung volume and/or
decreased respiratory compliance due to fluid accumulation in the
pleura and/or pulmonary spaces (via spirometer or pressure sensor)
and/or enlargement of the heart, increased pathologic lung sounds
(via the acoustic sensor/microphone), increased end-tidal CO2
and/or an increased respiratory rate (via the pressure sensor or
spirometer) then the healthcare provider or patient may be alerted
that their condition is worsening.
[0033] In the home healthcare embodiment, the patient may then be
sent home with a networked device (or return to the clinic) for
repeat measurements. In the instance where this device is used in
combination with daily weighings on a networked scale (the
preferred embodiment for congestive heart failure), the airway
device/controller may communicate with an existing network provided
by the scale or other in-home patient monitoring device, or any
network, to alert the user and/or healthcare provider. In this way,
the patient's cardiac health can be monitored remotely and
noninvasily. This technique may also be used in lieu of
radiographic examination to look for pneumo- or hemo-thorax
following a procedure. Tension pneumothorax and detection of any
other lung pathology may be accomplished with this technology, as
well, in the hospital, office, or home setting.
[0034] In an alternative embodiment, the airway device/controller
may record noises directly within the respiratory tract. In this
embodiment, the airway device/controller may incorporate a
disposable or reusable microphone attached to the ventilator, vent
tube or endotracheal tube which can track respiratory sounds and
rapidly report the onset of respiratory distress, pneumonia, rales,
rhonchi or other changes in lungs sounds. In its preferred
embodiment the airway device/controller may incorporate noise
cancellation functions. In one such embodiment, two microphones may
be used within the airway device with one microphone facing the
airway and the other microphone in a similar position within the
airway device but sealed off from the airway. The signal from the
sealed off microphone may then be subtracted from the microphone
open to the airway thereby cancelling out ambient noise and
allowing resolution of the physiologic sounds (cardiac,
respiratory, gastrointestinal, etc.).
[0035] In some embodiments, the airway device/controller could be
used in the placement and/or continuous monitoring of an
endotracheal tube (ET). ET placement is related to causes of
infection in ventilator-acquired pneumonia patients: poor placement
can lead to pooling of fluid and, within the fluid, bacterial
colonization can occur which then can migrate through the ET or
around the cuff of the ET and into the lungs. Pooling of fluid
and/or changes in respiratory flow/pressure can be monitored to
obtain an early onset indication of infection. Bacteria may also be
detected through sensors on the device.
[0036] In yet another embodiment, the airway device/controller can
detect pathologic behavior of the heart valves. For example, when
used in combination with an ECG, the expected mechanical heart
behavior and timing of the cardiac cycle is known. By comparing the
electrical and mechanical signals, improper mechanical function can
be detected, such as the timing of the contraction of the atria or
ventricles and opening or closing of the heart valves. Furthermore,
the intensity and timing of these signals can also be used to
diagnosis pathologies--for example, whether certain phases of the
cardiac cycle are prolonged or incomplete, such as with mitral
valve regurgitation. This information may be used alone or in
combination with the sound information described above or with any
other technique for diagnosing heart murmurs in order to better
understand the underlying heart function or dysfunction.
[0037] This and any of the embodiments described herein may be
utilized in a continuous or intermittent manner. The airway device
may be designed to be worn by the user or require additional
equipment to function and may be applied to the nose and/or mouth
or applied directly to an endotracheal tube. The airway
device/controller and any or all of its functions may be used in
any setting including: the home, office, clinic, hospital ward, ASC
or ICU.
[0038] The airway device/controller may be used to monitor chronic
conditions and/or detect acute conditions including: COPD, asthma,
CHF, cancer, stroke, pulmonary embolism, and any other condition
that could have an impact on respiratory rate, temperature, stroke
volume, heart rate, tidal volume, lung sounds, heart sounds, GI
sounds, pO2, pCO2, pH, or any other of the monitored
parameters.
[0039] The airway device may incorporate a controller to analyze
the signals from the various sensors. Alternatively, all, or part,
of a controller may exist separately from the airway device and
communicate with the airway device either wirelessly (via internet,
intranet, WAN, LAN or other network, or it may be local via
Bluetooth, Wi-Fi, etc.) or wired. If the connection is wired, it
may be continuous or intermittent. For example, the data from the
airway device may be periodically transmitted via a USB connection
or other type of connection after data has been collected. A
wireless connection may also be continuous or intermittent. The
controller may be, or communicate with, one or more mobile devices,
computers, servers, etc.
BRIEF DESCRIPTION OF THE DRAWINGS
[0040] FIG. 1 shows one embodiment of the airway
device/controller.
[0041] FIG. 2 shows an embodiment of the airway
device/controller.
[0042] FIG. 3 is a graph showing an ECG overlaid on airway pressure
data.
[0043] FIG. 4 is a graph showing pressure data from the ventilation
tube of an animal.
[0044] FIG. 5 shows a graph of the ECG curve as well as
corresponding cardiogenic oscillations waveforms.
[0045] FIG. 6 shows an embodiment of the airway
device/controller.
[0046] FIG. 7 shows an embodiment of the airway
device/controller.
[0047] FIG. 8 shows an embodiment of the airway
device/controller.
[0048] FIG. 9 shows an embodiment of the airway device used
wirelessly with a controller in the form of a smart phone.
[0049] FIG. 10 shows an embodiment of the airway device connected
to a controller in the form of a smart phone using a wired
connection.
[0050] FIG. 11 is a block diagram of a data processing system,
which may be used with any embodiments of the invention.
[0051] FIG. 12 shows an embodiment of a mouthpiece which includes a
restrictor.
[0052] FIG. 13 shows an embodiment of a mouthpiece which
incorporates a mechanical filter.
[0053] FIG. 14 shows an embodiment in which the restrictor and the
sampling exit are combined
[0054] FIG. 15 shows an embodiment which incorporates a flow
filter.
[0055] FIG. 16 shows a graph which demonstrates pulse pressure
variability.
[0056] FIG. 17 shows an embodiment of the airway device/controller
which includes a hand piece and at least some of the controller
functions.
[0057] FIG. 18 shows another embodiment of the airway
device/controller.
DETAILED DESCRIPTION OF THE INVENTION
[0058] FIG. 1 shows an embodiment of the airway device worn in the
mouth of a patient. One of the advantages of a portable embodiment,
such as this one, is that it can be worn by a subject that is not
only awake and not intubated, but upright and active. In other
words, the use of the airway device is not limited to patients on a
ventilator or other stationary medical device. The airway
device/controller may be used on a patient/user with no additional
ventilation support, or airway pressure support. Said another way,
the airway device/controller may be used on a patient without a
ventilator or CPAP machine or additional flow source, or any sort
of artificial ventilation or airway pressure support. The airway
device/controller may be used by patients/users who are breathing
naturally or normally, or may be used in a "prompt mode", where the
controller prompts the user to do something other than breathe
naturally. For example, the controller may prompt the user to hold
his/her breath, hold his/her breath after inhalation, hold his/her
breath after exhalation, hold his/her breath "now", etc.
[0059] The airway device 102 contains one or more sensors which can
measure and/or calculate airway pressure, airway flow, temperature,
sounds, respiratory rate, stroke volume, heart rate, tidal volume,
lung sounds, heart sounds, GI sounds, pO2, pCO2, pH, ECG, pulse
rate, pulse pressure, spirometry, analytes and/or compounds in the
breath (i.e. urea, markers of infection, O2, CO2, urea, water
vapor, alcohol, drugs, etc.) or analytes and/or compounds in the
saliva, such as glucose, etc.
[0060] A controller is either incorporated into the airway device
or a separate device which communicates with the airway device
either wirelessly or via a wired connection. The controller may be
incorporated into a ventilator, a stand-alone device or
incorporated into, or in communication with, a computer and/or
smartphone.
[0061] In a preferred embodiment, the controller is incorporated
into a smartphone which communicates wirelessly with the airway
device, either on a continuous or intermittent basis. Data
transferred from the controller may also be transmitted to/from a
remote server, for example, via the internet or an intranet. Data
from the controller may also be anonymized. Anonymized data may be
aggregated across patients for trends analysis. Data collected may
include metadata such as patient ID, timestamp, patient medical
history, such as weight, medications, etc. Use of the term "airway
device" herein may include a controller component.
[0062] The airway device may have a portion within the mouth or be
completely external. It may also be over the nose either instead
of, or in addition to, the mouth. The airway device may
purposefully block the nose. The airway device may also be
incorporated into an endotracheal tube.
[0063] FIG. 2 shows a detailed view of an embodiment of airway
device 200. This embodiment includes external opening section 204,
mouthpiece section 206 and neck section 208. The mouthpiece device
includes at least two airway lumens, exhalation airway lumen 210
and inhalation airway lumen 212. In this embodiment, the two lumens
are separated by divider 214. Alternatively, only one lumen may be
present.
[0064] Gas outflow vent 216, in the exhalation airway lumen, may
include a spirometry function. The vent may also maintain or cause
to be maintained a slight positive pressure so that the airway of
the subject remains open during breathing, which aids in the
ability to sense certain parameters.
[0065] The air inflow, or inhalation airway lumen, and/or the
exhalation airway lumen, may include one-way 218 valve to help
direct exhaled air through the exhalation airway lumen during
breathing.
[0066] Sensors 222, 224, and 226 may sense any of the parameters
listed herewithin. Sensors may be placed in the exhalation airway
lumen 210, the inhalation airway lumen 212, or on the outside of
the airway device. Sensors 222 on the outside of the device will
generally be for contact sensing with the mucosa and/or the lips,
such as ECG sensors. Sensors 224 in the exhalation airway lumen may
measure parameters associated with exhaled air, including pressure,
flow, sounds, temperature, O2, CO2, urea, water vapor, alcohol,
drugs, etc. Sensors 226 in the inhalation airway lumen may measure
parameters associated with inhaled air, including O2, CO2, urea,
water vapor, alcohol, drugs, etc.
[0067] Generally, the sensors can be placed anywhere along the
length of the airway device, but there may be advantages to certain
locations for certain types of sensors. For example, sensors for
temperature, water vapor, alcohol, drugs etc. measured in exhaled
air, would likely be better placed closer to the subject.
[0068] Flow and/or pressure sensors can be placed anywhere along
the length of the airway device, but there may be an advantage to
placing these sensors in a narrow and/or constant diameter section
of the airway device such as within neck 208. A sensor or sensors
may also be placed on gas outflow vent 216.
[0069] A single use barrier may be used to cover mouthpiece section
206 to maintain sterility of the airway device. Alternatively, a
disposable mouthpiece section may be attached to the airway device
and removed after use. A heat-moisture exchanger may be used to
prevent humidity from the breath entering into the device.
Alternatively, the airway device may be sterilizeable or
disposable.
[0070] Airway device 202 may incorporate hardware and/or software
to either act as a controller, or communicate with a controller.
The airway device may also act as a "partial controller", where
some of the controller activities take place within the airway
device, and some take place within a separate controller
device.
[0071] Airway device may be made out of any suitable material or
materials, including polymer, metal, or any other material or any
combination of materials. Airway device is preferably relatively
light and portable.
[0072] Flow/pressure sensors may include orifice plates, cone
devices, Pitot tubes, Venturi tubes, flow nozzles, Fleisch or Lilly
type pneumotachometers, or any other suitable technology. Sensor
resolution is generally high. Pressure sensor range may be around
1.4E-4 mmHg. Pressure sensor range may be around 1.9 mmHg.
[0073] FIG. 3 shows a graph of an ECG along with simultaneously
measured airway pressure data. ECG data 304 is shown below airway
pressure data 302. Within the airway pressure, systolic pulse data
306 and diastolic pulse data 308 are clearly visible. Within the
3-lead ECG data, P wave 310, QRS complex 312, and T wave 314 are
all visible. The dotted arrows show where the QRS complex peak
lines up with the valleys of the pressure data.
[0074] FIG. 4 shows a detailed view of the pressure data between
respirations shown in graph 402. Cardiogenic oscillations can be
seen in detailed view 404 of pressure vs. time. The amplitude or
area under the curve for these pulses can be used as an indicator
of relative cardiac output and/or pulmonary artery pressure. Not
shown but also useful in the same manner are cardiogenic
oscillations in the flow signal.
[0075] FIG. 5 shows a graph of the ECG curve, the cardiogenic
oscillations waveform generated using data from pressure sensor(s),
and the cardiogenic oscillations waveform generated using data from
flow sensor(s) (from Tusman, Gerardo, et al. "Pulmonary blood flow
generates cardiogenic oscillations." Respiratory physiology &
neurobiology 167.3 (2009): 247-254.)
[0076] Also shown are the amplitude and the frequency of a
cardiogenic oscillations waveform.
[0077] FIG. 6 shows another embodiment of the airway device. The
neck portion 602 is extended so that it also serves as the
mouthpiece portion, which is more straw-like than the previously
shown embodiment.
[0078] FIG. 7 shows another embodiment of the airway device.
Mouthpiece area 702 is flat and designed to go over the lips/mouth.
Strap 704 may hold the device on the face of the subject.
[0079] FIG. 8 shows another embodiment of the airway device.
External opening section 802 of this embodiment is elongated and
more narrow than previously shown embodiments. Section 802 may be
flexible, as in flexible tubing, or may be rigid, or may be
partially flexible and partially rigid. Mouthpiece section 804
includes mouth shield 806 to help keep the device in place. The
various sensors and/or valves may be anywhere along the length of
this embodiment.
[0080] FIG. 9 shows an embodiment of the airway device and
controller where the controller is separate, at least in part, from
the airway device. In this embodiment, controller 904 is a smart
phone and communicates wirelessly with airway device 902, which may
include a wireless data transmitter.
[0081] FIG. 10 shows an embodiment of the airway device and
controller where the controller is separate, at least in part, from
the airway device. In this embodiment, controller 1002 is a smart
phone and communicates with airway device 1004 via a "wire" or
cable 1006, for example, a USB cable. In this embodiment data may
be collected and stored in airway device 1004 and periodically
uploaded to controller 1002 via the cable.
[0082] The controller, whether it is separate from the airway
device, or incorporated into the airway device, or some functions
are located in the airway device and some located separately, may
function as follows. The controller collects the data from the
various sensors and analyzes them to determine cardiac output,
stroke volume and/or cardiac function and/or other parameters. In
addition, the controller may prompt the subject to help obtain the
data from the sensors. For example, the controller may prompt the
subject to hold his/her breath. The breath holding prompt may
happen at certain phases of the breathing cycle, such as before or
after inhalation and/or exhalation. The controller may prompt the
subject to breath at a certain rate or to inhale, exhale, or hold
his/her breath for a certain time period. Indicators may be present
on the controller and/or the airway device to help the subject time
certain activities. For example, the controller may prompt the
subject to hold his/her breath until a light on the controller
and/or airway device turns green, or until an auditory signal is
heard.
[0083] The controller may also determine whether the data it is
collecting is adequate for analysis. For example, if the subject's
airway is closing between breaths, the data may be more difficult
to analyze. The controller can sense when this is happening either
by the pressure/flow profile or other parameters and can prompt the
subject to adjust his/her breathing. For example, the controller
may prompt the subject to breath more slowly, or to sit still. In
addition, the controller may change the positive pressure of the
airway device to help keep the airway open. Some possible prompts
that the controller may provide to the subject are:
[0084] hold your breath for x seconds
[0085] hold your breath until the indicator does x
[0086] Breath normally until the indicator does x
[0087] exhale and then hold breath
[0088] inhale and then hold breath
[0089] breath normally
[0090] breath more slowly
[0091] Breath more quickly
[0092] Breath in slowly
[0093] Breath out slowly
[0094] Breath in quickly
[0095] Breath out quickly
[0096] testing is complete
[0097] begin exercising
[0098] end exercise
[0099] Other prompts are also possible. The prompts may change
depending on the data being collected. For example, if the
controller determines that the airway is closing between breaths,
the prompts may tell the subject to breathe differently, or the
controller may cause the airway device to apply positive pressure
to the airway. In addition, the user may be prompted at certain
time(s) of the day to use the device, so that the device is used at
the same time each day. For example, the device may prompt the user
to use the device upon waking.
[0100] Other parameters that may be considered in determining
whether the subject's breathing is optimal for data collection
include: variability of peak-to-peak period and magnitude, waveform
shape, etc.
[0101] The controller may analyze the data from the sensors to
determine other conditions, including COPD, asthma, CHF, cancer,
stroke, pulmonary embolism, dyspnea, paroxysmal, nocturnal dyspnea,
emphysema, and any other condition that could have an impact on
respiratory rate, temperature, stroke volume, heart rate, tidal
volume, lung sounds, heart sounds, GI sounds, pO2, pCO2, pH,
alcohol, urea, drugs, or any other of the monitored parameters.
[0102] Vagal tone/vasovagal syndrome may also be determined using
the present invention. Slight changes in heart beat parameters,
including amplitude, rate, waveform shape, etc., at different
stages of the breathing cycle can be measured and vagal tone
determined. For example, if the heart rate increases during
inhalation, this may indicate a high vagal tone.
Example of Data Processing System
[0103] FIG. 11 is a block diagram of a data processing system,
which may be used with any embodiment of the invention. For
example, the system 1100 may be used as part of a controller. Note
that while FIG. 11 illustrates various components of a computer
system, it is not intended to represent any particular architecture
or manner of interconnecting the components; as such details are
not germane to the present invention. It will also be appreciated
that network computers, handheld computers, mobile devices,
tablets, cell phones and other data processing systems which have
fewer components or perhaps more components may also be used with
the present invention.
[0104] As shown in FIG. 11, the computer system 1100, which is a
form of a data processing system, includes a bus or interconnect
1102 which is coupled to one or more microprocessors 1103 and a ROM
1107, a volatile RAM 1105, and a non-volatile memory 1106. The
microprocessor 1103 is coupled to cache memory 1104. The bus 1102
interconnects these various components together and also
interconnects these components 1103, 1107, 1105, and 1106 to a
display controller and display device 1108, as well as to
input/output (I/O) devices 1110, which may be mice, keyboards,
modems, network interfaces, printers, and other devices which are
well-known in the art.
[0105] Typically, the input/output devices 1110 are coupled to the
system through input/output controllers 1109. The volatile RAM 1105
is typically implemented as dynamic RAM (DRAM) which requires power
continuously in order to refresh or maintain the data in the
memory. The non-volatile memory 1106 is typically a magnetic hard
drive, a magnetic optical drive, an optical drive, or a DVD RAM or
other type of memory system which maintains data even after power
is removed from the system. Typically, the non-volatile memory will
also be a random access memory, although this is not required.
[0106] While FIG. 11 shows that the non-volatile memory is a local
device coupled directly to the rest of the components in the data
processing system, the present invention may utilize a non-volatile
memory which is remote from the system; such as, a network storage
device which is coupled to the data processing system through a
network interface such as a modem or Ethernet interface. The bus
1102 may include one or more buses connected to each other through
various bridges, controllers, and/or adapters, as is well-known in
the art. In one embodiment, the I/O controller 1109 includes a USB
(Universal Serial Bus) adapter for controlling USB peripherals.
Alternatively, I/O controller 1109 may include an IEEE-1394
adapter, also known as FireWire adapter, for controlling FireWire
devices.
[0107] Some portions of the preceding detailed descriptions have
been presented in terms of algorithms and symbolic representations
of operations on data bits within a computer memory. These
algorithmic descriptions and representations are the ways used by
those skilled in the data processing arts to most effectively
convey the substance of their work to others skilled in the art. An
algorithm is here, and generally, conceived to be a self-consistent
sequence of operations leading to a desired result. The operations
are those requiring physical manipulations of physical
quantities.
[0108] It should be borne in mind, however, that all of these and
similar terms are to be associated with the appropriate physical
quantities and are merely convenient labels applied to these
quantities. Unless specifically stated otherwise as apparent from
the above discussion, it is appreciated that throughout the
description, discussions utilizing terms such as those set forth in
the claims below, refer to the action and processes of a computer
system, or similar electronic computing device, that manipulates
and transforms data represented as physical (electronic) quantities
within the computer system's registers and memories into other data
similarly represented as physical quantities within the computer
system memories or registers or other such information storage,
transmission or display devices.
[0109] The techniques shown in the figures can be implemented using
code and data stored and executed on one or more electronic
devices. Such electronic devices store and communicate (internally
and/or with other electronic devices over a network) code and data
using computer-readable media, such as non-transitory
computer-readable storage media (e.g., magnetic disks; optical
disks; random access memory; read only memory; flash memory
devices; phase-change memory) and transitory computer-readable
transmission media (e.g., electrical, optical, acoustical or other
form of propagated signals--such as carrier waves, infrared
signals, digital signals).
[0110] The processes or methods depicted in the figures herein may
be performed by processing logic that comprises hardware (e.g.
circuitry, dedicated logic, etc.), firmware, software (e.g.,
embodied on a non-transitory computer readable medium), or a
combination of both. Although the processes or methods are
described above in terms of some sequential operations, it should
be appreciated that some of the operations described may be
performed in a different order. Moreover, some operations may be
performed in parallel rather than sequentially.
[0111] FIG. 12 shows an embodiment of an airway device which
includes a restrictor. The restrictor helps reduce turbulent air
flow within the airway device. Airway device 1202 in this
embodiment has mouth opening 1204, which is larger than restrictor
1206. Restrictor 1206 is open to ambient air. As the user exhales
into the airway device, restrictor 1206 restricts the airflow which
increases the laminar nature of the air flow within the airway
device. In this embodiment, as the user breathes through opening
1204, some air exits restrictor 1206, however some air, preferably
air which is predominantly flowing in a laminar manner, exits
sampling exit or lumen 1208. Sampling exit 1208 may connect
directly to a pressure, or other, sensor, or it may connect to a
pressure sensor or other sensor via connector 1210. The purpose of
restrictor 1206 is to reduce turbulence in the air flow within the
airway device so that the air exiting sampling exit 1208 is as
laminar as possible. Note that this figure is showing an exhalation
lumen only. A separate inhalation lumen may be incorporated into
the device and/or the subject may be asked to inhale separately,
either through his/her nose, or by removing the device from his/her
mouth. Alternatively, the patient may also use the exhalation lumen
for inhalation.
[0112] FIG. 13 shows an embodiment of an airway device which
incorporates a mechanical filter. In this embodiment there are at
least two sampling lumens, 1302 and 1304. One of the sampling lumen
includes mechanical low pass filter 1306. The pressure sensor in
this embodiment is a differential pressure sensor. Differential
pressure sensor 1308 is in fluid communication with at least two
sampling lumens or inputs, and compares the pressure reading
between the two lumens. This configuration produces a cleaner
pressure signal for analysis by circuit board 1310 by filtering out
the pressure from the breaths and leaving those from the
cardiogenic oscillations. Circuit board 1310 may be incorporated
into the airway device or may be separate, for example on a
separate controller, and communicated with either wirelessly or via
wire. In this embodiment, the circuit board is incorporated into
the airway device and communicates with a controller via wireless
transmitter 1312. In this embodiment, circuit board 1310 and
wireless transmitter 1312 may be considered to be part of the
controller as well, for purposes of defining the controller. Filter
1306 may be made out of any suitable material including foam or any
membrane that is semi-permeable to air. Note that this figure is
showing an exhalation lumen only. A separate inhalation lumen may
be incorporated into the device and/or the subject may be asked to
inhale separately, either through his/her nose, or by removing the
device from his/her mouth. Alternatively, the patient may also use
the exhalation lumen for inhalation.
[0113] The mechanical low-pass filter isolates the lower frequency
signals associated with natural breathing, which are subtracted
from the signal leaving only the higher frequency cardiac
oscillation signal. This filter may employ a partially-impermeable
barrier between differential sensing and reference inputs. The
high-frequency cardiac oscillation signal is seen by the sensing
input, whereas the pressure changes due to breathing are low
frequency enough to equilibrate across the membrane and are
detected at both inputs. By breathing into the device with a slight
expiratory pause, the COS signal can be reliably captured. Some
embodiments may incorporate an additional, less sensitive, pressure
sensor to monitor the entire breathing cycle and provide feedback
to the patient about the size and frequency of the breaths,
improving repeatability between measurements.
[0114] FIG. 14 shows an embodiment in which the restrictor and the
sampling exit are combined. Restrictor 1402 reduces the turbulence
in the airflow as air is breathed in and out of the airway device.
Breathed air exits and may enter via outlet 1404. Differential
pressure sensor 1308 may allow air to flow through it or alongside
it to exit the airway device, or alternatively, the airway device
may have an additional air exit (not shown). Note that this figure
is showing an exhalation lumen only. A separate inhalation lumen
may be incorporated into the device and/or the subject may be asked
to inhale separately, either through his/her nose, or by removing
the device from his/her mouth.
[0115] Note that the restrictor could be anything suitable, such as
a flow control valve, a pressure control valve, etc.
[0116] FIG. 15 shows an embodiment which incorporates a flow
filter. Flow filter 1502 decreases the turbulence of the airflow
coming into the airway device. In this embodiment, flow filter 1502
is used instead of a restrictor. The airway device may have an
additional air exit (not shown). Flow filter 1502 may be made out
of any suitable material such as polymer and in any suitable
configuration such as a honeycomb or parallel capillary
configuration. Note that this figure is showing an exhalation lumen
only. A separate inhalation lumen may be incorporated into the
device and/or the subject may be asked to inhale separately, either
through his/her nose, or by removing the device from his/her
mouth.
[0117] Any of the embodiments herein can be adapted to be used
inside the mouth, or partially inside the mouth. For example, an
airway device deeper inside the mouth may be advantageous in
keeping the airway open for cleaner pressure measurements.
Furthermore, any of the embodiments herein may also be adapted to
be used with patients who are tracheally intubated, in which case
the devices described are attached to or in-line with the tracheal
tube.
[0118] FIG. 16 shows a graph which demonstrates pulse pressure
variability. As mentioned earlier, variability in the respiratory
pulse pressure waveform can be used to determine hydration status,
as well as volume status, and also pulmonary artery compliance. The
graph in FIG. 16 shows the pulse pressure at end inspiration and at
end expiration. Pulse pressure is defined as the difference between
the systolic and diastolic pressure readings, or the amplitude of
the waveform (lowest point to highest point). The difference in
amplitude between these two waveforms is the pulse pressure
variability. A large variability may indicate dehydration, where a
decrease in variability over time may be an indicator that
hydration is being restored or has been restored.
[0119] FIG. 17 shows an embodiment of the airway device/controller
which includes a hand piece and at least some of the controller
functions. The airway device of this embodiment includes 2
mouthpieces 1702 and 1704. The user breaths into one of these
mouthpieces and breath exits through the other mouthpiece. Hand
piece 1706 is held by the user or by the user's physician. Display
1708 displays one or more display areas 1710. These display areas
may include buttons, or links, to more information, such as
settings, waveforms, including waveforms showing HR (heart rate),
SV (stroke volume), CO (cardiac output), PAC (pulmonary arterial
compliance, etc., analytical results of waveform analysis, triggers
for alarms/notices, etc. The airway device/controller of this
embodiment may communicate wirelessly, or in a wired manner with
one or more mobile devices, computers, servers, etc.
[0120] FIG. 18 shows another embodiment of the airway
device/controller. This embodiment includes controller 1802, signal
transmission tubing 1804, heat-moisture exchanger 1806 and
mouthpiece 1808.
[0121] Embodiments of the airway device/controller may also be
incorporated with a standard or specialized inhaler, for example
for asthma. The airway device/controller in these embodiments may
include a feature which tracks usage of the airway device and/or
inhaler to monitor use compliance.
[0122] Embodiments of the airway device/controller may include
integration with electronic health records (EMR) or electronic
health records or other systems. For example, data from the
controller may be transmitted wirelessly (or wired) to a server in
the internet which integrates the data with that of an EMR. The
patient ID (possibly anonymized) would be integrated into the
metadata of the data transmitted by the controller so that the data
would be integrated with the correct patient's medical record.
[0123] Data from multiple airway devices/controllers may be
collected and aggregated and analyzed for trends. This data may be
anonymized to comply with privacy rules.
[0124] In some embodiments of the airway device/controller,
respiratory sinus arrhythmias (changes in heart rate due to
breathing) may be tracked as an indicator of heart health or heart
failure. Deviations from trends may be indicative of heart failure
issues and may provide an alert. Because the data collected by the
airway device may be continuous, for example, while the user
sleeps, deviations from the norm (either for that patient or for a
patient population) may indicate changes in health, and in
particular, heart health.
[0125] In some embodiments of the airway device/controller, the
device is used in an ambulatory manner. In other words, the user
may use the device while walking around, watching TV, working,
sleeping, resting, exercising or while performing everyday
activities. The user is not tied to a stationary device, hospital
nor clinic.
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