U.S. patent application number 11/682601 was filed with the patent office on 2007-09-13 for monitoring and quantification of smoking behaviors.
Invention is credited to P. Alexander Derchak.
Application Number | 20070209669 11/682601 |
Document ID | / |
Family ID | 38475508 |
Filed Date | 2007-09-13 |
United States Patent
Application |
20070209669 |
Kind Code |
A1 |
Derchak; P. Alexander |
September 13, 2007 |
MONITORING AND QUANTIFICATION OF SMOKING BEHAVIORS
Abstract
The invention provides methods for characterizing a subject's
overall smoking behavior and the subject's puff morphology in
dependence on tidal volume information provided by ambulatory
physiological monitoring. This invention also systems for executing
the methods of this invention and computer-readable media having
encoded the methods of this invention.
Inventors: |
Derchak; P. Alexander;
(Ventura, CA) |
Correspondence
Address: |
WINSTON & STRAWN LLP;PATENT DEPARTMENT
1700 K STREET, N.W.
WASHINGTON
DC
20006
US
|
Family ID: |
38475508 |
Appl. No.: |
11/682601 |
Filed: |
March 6, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60781468 |
Mar 9, 2006 |
|
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Current U.S.
Class: |
131/329 |
Current CPC
Class: |
A61B 5/398 20210101;
A24F 47/00 20130101; A61B 5/091 20130101; A61B 5/0205 20130101;
A61B 5/389 20210101; A61B 5/6805 20130101; A61B 5/0002 20130101;
A61B 5/1135 20130101; A61B 5/369 20210101; A61B 5/335 20210101 |
Class at
Publication: |
131/329 |
International
Class: |
A24F 25/00 20060101
A24F025/00 |
Claims
1. A method for characterizing a subject's smoking behavior
comprising: receiving ambulatory monitoring data, including data
reflecting tidal volume (Vt); searching received Vt data for
candidate puffs which are breaths having one or more
characteristics indicative of a puff; determining whether or not a
candidate puff is an actual puff based on the number and type of
all puff-indicative characteristics recognized; and storing puff
occurrence data, including times of occurrence data, and puff
characteristic data.
2. The method of claim 1 wherein puff-indicative characteristics
include one or more of inspiratory durations, and/or flow rates
and/or volumes; or expiratory durations, and/or flow rates and/or
volumes; or duration of the period between an expiration and the
follow inspiration.
3. The method of claim 1 wherein actual puff determination is
suspended during periods of activity sufficient to cause puff
determination to be unreliable.
4. The method of claim 1 further comprising characterizing the
subject's overall smoking behavior in dependence on the stored puff
occurrence data.
5. The method of claim 1 further comprising searching at least one
actual puff for morphological features; storing puff morphology
data; and characterizing the subject's puff and manner of smoking
in dependence on the stored puff morphology data.
6. The method of claim 1 wherein puff morphology features include
one or more of inspiratory durations, and/or flow rates and/or
volumes; or expiratory durations, and/or flow rates and/or volumes;
or duration of the period between an expiration and the follow
inspiration.
7. A method for characterizing a subject's smoking behavior
comprising: receiving ambulatory monitoring data, including data
reflecting tidal volume (Vt); searching received Vt data for
candidate puffs which are breaths having one or more
characteristics indicative of a puff; determining whether or not a
candidate puff is an actual puff based on the number and type of
all puff-indicative characteristics recognized; storing puff
occurrence data, including times of occurrence data, and puff
characteristic data; and searching at least one actual puff for
morphological features; storing puff morphology data; and
characterizing the subject's overall smoking behavior and the
subject's puff behavior in dependence on the stored puff occurrence
data and on the stored puff morphology data.
8. The method of claim 7 further comprising correlating the
subject's overall smoking behavior and the subject's puff behavior
with indicia of the functioning of other physiological systems.
9. The method of claim 7 further comprising estimating the
likelihood and severity of possible smoking-related diseases in
dependence at least on part on the stored puff occurrence data and
on the stored puff morphology data.
10. The method of claim 7 further comprising providing biofeedback
to the subject in dependence at least in part on the stored puff
occurrence data and on the stored puff morphology data.
11. A system for characterizing a subject's smoking behavior
comprising: an ambulatory monitoring device providing physiological
monitoring data, including data reflecting Vt; and a computer
operatively coupled to the ambulatory monitoring device and
including a computer-readable memory with encoded instructions for
performing the methods of claim 1.
12. The system of claim 11 wherein the encoded instructions for
further performing the methods of claim 5.
13. The system of claim 11 wherein the computer is operatively
coupled to a plurality of ambulatory monitoring devices.
Description
[0001] This application claims the benefit of U.S. provisional
application No. 60/781,468 filed Mar. 9, 2006, the entire content
of which is included herein by reference in its entirety for all
purposes.
FIELD OF THE INVENTION
[0002] The present invention is related to ambulatory physiological
monitoring, and in particular to automatic systems and methods that
quantify a subject's overall smoking behaviors over time and that
quantify characteristics of the subject's method of smoking, e.g.,
the nature of the subject's puffs.
BACKGROUND OF THE INVENTION
[0003] Smoking, whether of cigarettes, cigars, pipes, or other
smoking materials, is well known as a serious health problem
worldwide leading to significant morbidity and mortality primarily
from induced lung disease. It is advantageous to provide smokers
with facilities and information to aid them to cease smoking, or to
limit smoking, or to smoke in less pathogenic ways. It is also
advantageous to estimate the likelihood and severity of possible
lung disease in dependence on a subject's smoking behavior. It is
also advantageous to monitor and to quantify the average smoking
behaviors of several subjects and/or of populations of subjects for
public health, research, and other purposes.
[0004] Automatic systems and methods to monitor and quantify a
subject's smoking behaviors over time and to monitor and quantify
the characteristics of the subject's method of smoking are not
available in the prior art.
[0005] Objects of the present invention are to provide systems and
computer-implemented methods that provide smokers with such
information.
SUMMARY OF THE INVENTION
[0006] This invention includes the use of an ambulatory
cardio-respiratory monitoring system to provide data that can be
processed and interpreted to monitor and quantify specific
characteristics of a subject's cigarette and other types of
smoking. This monitoring will enable a greater understanding of the
interaction between smoker and cigarette, or other smoking
material. It will also aid individual smokers to cease, limit, or
improve their smoking behaviors.
[0007] The invention provides methods to analyze ambulatory and/or
clinical and/or laboratory monitoring data to characterize a
subject's overall smoking behavior and details of the subject's
smoking behavior, i.e., characteristics of the subject's individual
puffs and overall puffing pattern, and how these behaviors very
with different smoking materials. Overall smoking is determined in
dependence on the number of puffs and on the times of their
occurrence as revealed by the monitoring data. The invention
identifies specific characteristics that indicate a breath is a
puff, and further identifies important morphological
characteristics of individual puffs. In preferred embodiments,
computer-implemented methods examine tidal volume (Vt) data for
puff-indicating characteristics to identify puffs. Further, it is
preferred that these computer-implemented methods also examine Vt
data of each puff to identify important morphological
characteristics. Puff occurrence data and puff morphology data are
retained and statistically summarized in order to provide
characterization of all aspects of a subject's smoking behavior,
i.e., a subject's overall smoking behavior and details of how the
subject puffs
[0008] Single puffs can also be monitored and quantified by
determining puff inspiratory and puff expiratory volume, flow, and
timing. Additionally, effects of smoking on heart rate, heart rate
variability, and activity can be correlated if cardiac data is also
available. Further, smoking patterns and smoker interaction with
their smoking implement can provide diagnostic information related
to smoking addiction and prognostic information related to
likelihood of development of smoking related diseases.
[0009] Additionally, complete ambulatory and/or clinical and/or
laboratory monitoring data, including cardiac, respiratory, and
activity data enables detailed correlation of the
activities/actions of smoker related to the inspiration, holding,
and expiration of smoke and of the effect of smoking on subsequent
respiratory pattern, blood oxygen saturation, heart-rate and heart
rate variability, pre- and post-smoking physical activity level,
and the like. Continuous monitoring during a day and night permits
correlation of variations in smoking habits with respiratory
pattern and subsequent sleep latency, sleep time and sleep
quality.
[0010] Other aspects of the invention include monitoring the ways
in which smokers smoke cigarettes of different types, such a
filtered, non-filtered, menthol, low-tar, etc, and with cigars,
pipes and other smoking implements. Other aspects of the invention
include use of monitoring data as bio-feedback information for
smokers wishing to modify their smoking behaviors in order to wean
themselves from the smoking related nicotine addiction. Other
aspects of the invention include the use of smoking behavior data
to estimate the likelihood and severity of smoking associated
diseases with more accuracy than estimates based on "packs per day"
smoked. Other aspects of the invention include collecting smoking
behavior data from various subject populations and storing this
data in databases for various public health, research, and other
purposes.
[0011] A preferred ambulatory monitoring system is capable of
monitoring tidal volume, the relative contributions of rib cage and
abdominal expansion to tidal volume, heart rate, ECG, motion, blood
oxygen saturation, posture, and activity. Such systems are
available from VivoMetrics, Inc., Ventura, Calif.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] The present invention may be understood more fully by
reference to the following detailed description of the preferred
embodiment of the present invention, illustrative examples of
specific embodiments of the invention and the appended figures in
which:
[0013] FIG. 1 illustrates a 5 minute and 45 second smoking
record;
[0014] FIG. 2 illustrates morphology of a first puff;
[0015] FIG. 3 illustrates morphology of a second puff;
[0016] FIG. 4 illustrates morphology of a third puff;
[0017] FIG. 5 illustrates morphology of a fourth puff; and
[0018] FIGS. 6A-B illustrates a preferred ambulatory monitoring
system and exemplary embodiments of the methods of this
invention.
DETAIL DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0019] Preferred embodiments of the invention are now described.
These embodiments do not limit the scope of the invention, since
these embodiments are illustrations of several preferred aspects of
the invention. Any equivalent embodiments are intended to be within
the scope of this invention. Indeed, various modifications of the
invention in addition to those shown and described herein, such as
alternate useful combinations of the elements described, will
become apparent to those skilled in the art from the subsequent
description. Such modifications and combinations are also intended
to fall within the scope of the appended claims. In the following
(and in the application as a whole), headings and legends are used
for clarity and convenience only.
[0020] This invention is useful for subjects that are monitored
while ambulatory or that are monitored while in the clinic. This
invention is further useful for laboratory monitoring and studies.
Although, this invention may be described as "ambulatory", or as
"clinical", or as laboratory" in this application, use of these
words individually in not intended to limit the applicability of
this invention.
Smoking Analysis Methods
[0021] The act of smoking results in characteristic patterns of
cardio-respiratory, ambulatory monitoring data. The present
invention provides systems and computer-implemented methods to
recognize and to quantify these characteristic patterns. These
methods are now described with reference to FIG. 1-4, which
illustrate exemplary smoking patterns. Preferred ambulatory
monitoring devices and data analysis systems are described
subsequently.
[0022] Methods of this invention can be broadly divided, first,
into those that recognize puffs in cardio-respiratory data and then
quantify a subject's overall smoking behavior over time (smoking
behavior methods) in dependence on recognized puffs. A second group
of methods are those that examine each puff in detail in order to
quantify and classify the subject's manner of smoking (manner of
smoking methods or puff morphology methods).
[0023] Turning first to smoking behavior methods, FIG. 1
illustrates cardio-respiratory monitoring data from a subject
during a 5 min. 45 sec period of smoking. The Vt trace is the
subject's tidal volume; the RC and AB traces are expansions and
contractions of the subject's rib cage and abdomen, respectively;
the spikes on the trace labeled Br/M mark the beginning of each
breath and the height of a spike indicates the volume of the
associated breath; the height of spikes in the trace labeled Ve/Vol
trace indicate the expiratory volume of the associated breath; the
ECG trace is the concurrent electrocardiogram; the HR trace is the
heart rate; and the ACC trace is accelerometer data reflecting
subject activity. During this period, the subject puffed 14 times
as indicated by the highlighted bands. These puffs have
distinguishing characteristics, and the computer-implemented
methods of the invention recognize occurrences of puffs by
examining the record for these distinguishing characteristics.
[0024] Puffs 11 illustrate the waveform characteristics and
features signaling a puff. First, puffs typically have durations
approximately 2.5 to 3.0 times longer than the durations of
adjacent breaths, and amplitudes approximately 2 times greater than
the amplitudes of adjacent breaths.
[0025] Second, puffs have a characteristic shape, again illustrated
by puffs 11. A puff is a single breath with a single inspiratory
phase and a single expiratory phase. In most cases, the slope of
the expiratory phase is substantially constant or slowly varying
(the relative change in slope being less than approximately 50%).
However, the inspiratory phase often includes two segments of
similar slope separated by an intervening period of low to zero but
never negative. That is, exhalation does not occur in the
intervening period. However, the slope of the inspiratory phase is
also often substantially constant or slowly varying. The
inspiratory and expiratory phases can be separated by
breath-holding periods at substantially constant but elevated lung
volume.
[0026] Accordingly, one primary feature signaling a puff is a
breath with a duration and amplitude both of which approximately
1.5 to 2.0 times longer or greater, respectively, than adjacent
breaths. The greater these deviations, the greater is the
confidence that the particular breath is a puff. A further primary
signaling feature a substantially single inspiratory phase, which
may be interrupted by a period at a substantially constant lung
volume, and a substantially single expiratory phase. A breath
holding period at a substantially constant, elevated lung volume
may separate inhalation and exhalation. A puff characteristically
has no further structure. In fact, further structure indicates the
breath is not likely to be a puff, being instead, perhaps, a cough,
or a sigh, or a period of speech, or the like. A secondary feature
is heart rate which is usually decreasing over most of the puffs
duration.
[0027] Thus, a puff is preferably identified as a breath having a
pre-determined combination of these primary and secondary features,
presence of absence of features being determined by
computer-implemented examination of monitoring data. Puffs are most
reliably recognized during periods of limited subject activity,
which can be indicated by a motion sensor, e.g., an accelerometer,
that is part of the ambulatory monitoring apparatus. In FIG. 1, the
ACC trace is an accelerometer trace indicating limited subject
activity. During more intense activity, normally increased minute
ventilation and motion artifacts can mimic some of all of the
features of puffs. Optionally, puff identification can be suspended
during such activity and the period of suspension noted in the data
set.
[0028] Overall smoking behaviors can be abstracted from identified
puff occurrences and the times of puff occurrence. For example, the
total puffs during a day can be counted. This measure is expected
to be a more reliable indicator of pulmonary exposure to tobacco
smoke than is the number of cigarettes (or packs) smoked per day.
Further, the number smoking periods during a day as well as their
length and time of occurrence can be summarized. Further, these
quantitative measures of smoking can be correlated with patterns in
other cardio-respiratory parameters, such as heart rate and its
variability and breath rate, tidal volume, and the like and their
variability. Further, for monitoring that extends over all or part
of a day and the following night, quantitative measures of smoking
can be correlated with objective measures of sleep time and quality
in order to ascertain effects of smoking on sleep. Sleep can be
assessed by time spent in various sleep stages, the number of
nocturnal arousals, and the like. In preferred embodiments, sleep
parameters and determined from cardio-respiratory and motion
monitoring data. See <<<non-eeg sleep>>>
application included in its entirety herein by reference for all
purposes.
[0029] Turning next to the manner of smoking methods, puff
morphology is important in improving estimates of pulmonary
exposure to tobacco smoke, which are initially provided by the
smoking behavior methods. Different puff morphologies are known to
result in lesser or greater smoke exposure. Shorter puffs, and
puffs consisting of a single inspiration followed closely by a
single expiration without noticeable breath holding, limit both
smoke exposure time and location of smoke exposure in the pulmonary
tree. In particular, such puffs result in reduced smoke and
particulate exposure of the smaller bronchioles and alveoli. These
pulmonary components are more sensitive to smoke-induced injury
causing ultimately to emphysema and/or COPD. On the other hand,
longer puffs and puffs with breath holding provide more time for
distribution and diffusion of smoke and particulates in the
respiratory tree, leading to increased smoke and particulate
exposure of the smaller bronchioles and alveoli receive and to
increased likelihood of their injury. Further, a puff primarily due
to rib cage expansion tends to lead to only limited smoke exposure
in the peripheral airways. Conversely, a puff with relatively equal
expansion of the rib cage and the abdomen tends to cause increase
smoke exposure in the peripheral airways. Since puff morphology
affects airway smoke exposure, this morphology can provide
prognostic information concerning the occurrence and severity of
smoking related lung diseases.
[0030] Accordingly, methods of the second class preferably
recognize additional features in the tidal volume trace including,
for one or more previously identified puffs: duration in seconds;
presence or absence of a reduced-amplitude puff prior to the
primary inhalation; relative importance of rib cage and abdominal
motions in the puff; relative duration of inhalation and of
exhalation; whether inhalation and exhalation are smooth or any
interrupted with multiple phases; duration of breath holding if
any; lung volume during breath holding; and the like. Total
duration of a true puff is approximately the duration of any
reduced prior puff, plus the duration of inhalation, plus the
duration of any breath holding, and plus the duration of
exhalation. FIGS. 2-4 illustrate puffs of various types which
illustrate these waveform features.
[0031] FIG. 2 illustrates a mono-phasic-type puff which is simply
an inhalation followed by an exhalation without significant breath
holding. This type of puff includes the following features: reduced
initial puff 21, followed by primary inhalation 23 and primary
exhalation 25. Both the inhalation and exhalation have slopes that
are smoothly varying without evident phases or interruptions. This
puff has no breath holding between inhalation and exhalation, and
rib cage expansion 27 makes a significantly greater contribution to
this puff than does abdominal expansion 29.
[0032] FIG. 3 illustrates a puff with a single breath holding phase
but it otherwise generally similar to the puff of FIG. 2. This puff
includes the following features: reduced initial puff 41;
inhalation 43 with smoothly varying slope; breath holding 45 after
partial expiration; and exhalation 49. Again, the inhalation and
exhalation have smoothly varying slopes with the lung volume at the
end of exhalation lower than the lung volume at start of
inhalation. Breath-holding-period duration is less than 50% of puff
duration and includes a slow exhalation; it is therefore a less
prominent breath holding. The height of indicator 49 is
proportional to expiratory volume and time of expiration. Here, the
contribution of rib cage expansion 42 and abdominal expansion 44
are more comparable although rib cage expansion still
dominates.
[0033] FIG. 4 illustrates a puff with more prominent breath
holding. Here, breath holding 55 is more prominent: it extends for
more than half the pulse duration; lung volume during breath
holding is approximately at an end-inspiratory volume comparable to
adjacent breaths; and the lung volume is substantially constant
during breath holding. Also, the contribution of rib cage expansion
52 is here only marginally greater than the contribution of
abdominal expansion 54. The height of indicator 59 represents a
large expiration prior to inhalation. Inhalation 53 and exhalation
57 again have smoothly varying slopes with phases or
interruptions.
[0034] FIG. 5 illustrates very prominent breath holding at high
lung volumes along with a biphasic inhalation. The inhalation
displays an initial phase 71 followed by a breath holding
interruption 73 at an approximately constant lung volume that is
considerably higher than the end-inspiratory volume of adjacent
breaths. Inhalation resumes 75 drawing more smoke into the lungs
and distributing the already-present smoke further into the lung
periphery. Following this inhalation phase is a further period of
breath holding 77 at an even higher lung volume. These breath
holding periods inhale a volume of smoke that is 2 to 3 times the
tidal volume of adjacent normal breaths. This puff ends with smooth
expiration 79 back to the lung volume and the beginning of
inhalation. Here, approximately equal rib cage 72 and abdominal 74
expansions are needed to inhale and hold this significant volume of
smoke.
[0035] Accordingly, a basic morphological classification of puffs
preferably includes at least the duration and volume of the puff in
comparison to adjacent normal breaths, and the relative duration of
breath holding and the lung volume during breath holding, again in
comparison to adjacent normal breaths.
Preferred Systems
[0036] Preferred ambulatory monitoring and data analysis systems
are now described which gather the data analyzed by the described
smoking behavior and puff morphology methods. Physiological data
can be gathered by a wide variety of monitoring systems designed
for, e.g., in-hospital use, or in-clinic use, or ambulatory use, or
other uses. Without limitation or prejudice, however, the following
description is largely in terms of preferred monitoring systems for
ambulatory use.
[0037] In order to perform normal daily waking and sleeping
activities, a monitored subject should be only minimally, if at
all, constrained by a monitoring device. In preferred embodiments,
therefore, physiological sensors are attached to, or affixed to, or
carried by, or incorporated in or as part of ordinary wearable
items that are unobtrusive, comfortable, and useable without
assistance. Suitable wearable items include garments, jackets,
bands, patches, and the like, made from a variety of materials,
particularly elastic materials to insure a snug fit; they can be
donned in one piece or include zippers, Velcro, snaps, and the
like, that are joined after donning. Sensors can be incorporated
into garments in many ways, for example, by weaving, or knitting,
or braiding into a garment's fabric; or by being sewn or carried
on, or mounted in, or attached to the garment; also flexible
sensors can be glued, printed, sprayed and so forth onto inner or
outer garment surfaces. See, e.g., U.S. Pat. Nos. 6,551,252 and
6,047,203. For example, FIG. 6A illustrates shirt-like garment 125
to which sensors 127 and 129 are affixed or attached. This garment
can be joined by a zipper, Velcro, or the like along the ventral
midline; optionally it can be one piece.
[0038] Many types of sensors can be incorporated in wearable,
monitoring items. One useful physiological sensor, referred to
herein generically as a "size sensor", gathers signals responsive
to size indicia describing portions of a monitored subject's body,
e.g., the torso, the neck, the extremities, or parts thereof. Size
sensor signals can be processed to yield information about organ
system functioning. In particular, signals from size sensors at one
or more levels of the torso, e.g., at an abdominal level and at a
rib cage level, can be interpreted using a two-component breathing
model in order to determine respiratory rates, respiratory volumes,
respiratory events, and the like. See, e.g., U.S. Pat. Nos.
6,551,252; 5,159,935; 4,777,962; and U.S. patent application Ser.
No. 10/822,260.
[0039] Preferred size sensors are based on inductive
plethysmographic (IP) technologies. Briefly, the impedance of a
conductive element is known to reflect size and shape of the
element. Therefore, the impedance of a conductive element
configured to lie on a portion of a body part, or to partially or
fully encircle a body part, or otherwise arranged on the body of a
subject changes as the size of the underlying body part changes due
to, e.g., respirations, pulsations, voluntary motions, cardiac
activity, and the like. IP technology measures this impedance and
consequently reflects such physiological functioning. However,
useful size sensors can be based on diverse other technologies
known in the art. Active elements of size sensors can be based on
thread and fabric technologies. The exemplary garment of FIG. 6A
includes two size sensors 127 at rib cage and abdominal levels,
which return signals that can be processed into respiratory
information.
[0040] In addition to size sensors providing respiratory and/or
cardiac information, wearable items can include diverse additional
sensors for other physiological and/or non-physiological parameters
of a monitored subject. For example, accelerometers can sense
current activity level and body posture or orientations;
thermistors can sense skin or body core temperature; pulse
oximeters can sense blood oxygen level. Further, electrodes in
electrical communication with the subject can sensor such
electrical activities as electrocardiogram ("ECG") signals,
electroencephalogram ("EEG") signals, electro-oculogram ("EOG")
signals, electro-myogram ("EMG") signals (of the orbital, facial
and other muscles), skin conductance or resistance, and the like.
These electrodes can be as known in the art of can be fabric based,
or are otherwise flexible. Additional sensor can be mounted or
incorporated in various manners. FIG. 6A illustrates ECG electrodes
129 in contact with the subject through cutouts in garment 125.
Alternatively ECG electrodes can be mounted on the inner surface of
garment 125 to be directly in contact with the subject's skin, thus
obviating garment cutouts.
[0041] Wearable items are usually accompanied by local electronic
units, referred to herein as portable data units ("PDUs") that are
sufficiently compact and lightweight to be carried on or by the
monitored subject. PDUs preferably include IP sensor electronics
and also electronics for operating other sensors, and for
retrieving and digitizing (if necessary) sensor data. See, e.g.,
U.S. Pat. No. 6,551,252. PDUs are also preferably in two-way
communication, wired or wireless with physically local or
physically remote external server systems so that sensor data can
transmitted in real time. Alternatively, sensor data can be stored
for later access on, e.g., flash memory, or magnetic media, hard
drives, or the like.
[0042] External server systems typically receive and store data
from one or more PDUs, perform additional processing of received
data to determine further physiological information, and format and
display received for monitoring personnel. In preferred
embodiments, the methods of this invention are implemented on such
external systems. FIG. 6A illustrates PDUs 131 connected by wire to
the garment sensors and in wireless contact with external server
system 121. Server system 121 can be a PC-type or workstation-type
computer both of which are well known in the art. User interface
devices, such a display, mouse, and keyboard 123, preferably
accompany server systems for use by monitoring personnel.
[0043] Sensor signal processing whether in a PDU or in an external
systems generally includes filtering, digitization, noise limiting,
extraction of relevant signal components, specific processing of
respiratory size sensor signals. See, e.g., U.S. Pat. Nos.
6,413,225; 5,159,935; 4,834,766; 4,777,962; and U.S. application
Ser. No. 10/822,260. Signals from other sensors can also be
processed: R-waves can be recognized in ECG signals using known
methods; accelerometer signals can be low and high pass filters to
extract posture information and activity level information,
respectively; and so forth. See, e.g., U.S. application Ser. No.
10/991,877.
[0044] This methods of this invention are performed on software or
firmware programmable systems. In the case of software programming,
methods are coded in standard computer languages, such as C, C++,
or in high level application languages, such as Matlab and
associated toolboxes (Math Works, Natick, Mass.). Code is then
translated or compiled into executable computer instructions for
controlling a microprocessor or similar. In the case of firmware
programming, higher level method specifications written in software
languages or hardware languages such as VHDL, are generally
translated into bit codes by tools supplied by the manufacturer of
the hardware part that is being programmed. For example,
manufacturer's tools prepare bit-streams for configuring FPGAs. The
invention also includes software distributions, e.g., on
computer-readable media, having encoded the method of this
invention for execution on a computer or for programming a firmware
device.
Exemplary Embodiments of the Smoking Analysis Methods
[0045] The smoking analysis methods of this invention are
implemented as software programs that are preferably executed on
server systems that receive data from one or more ambulatory
monitoring devices. For example with reference to FIG. 6A, these
software programs can be executed on server system 121 with input
data received from monitoring garment 125 through PDU 131.
[0046] FIG. 6B illustrates a flowchart for an exemplary software
implementation. The first steps searches for puffs in input data
151 received directly or indirectly from an ambulatory monitoring
device. A tidal volume (Vt) waveform is obtain for this data and
searched 153 for breaths with the above-described puff-indicating
features. If a breath is found having sufficient puff-like
features, it is determined that a puff has been found 155;
otherwise the program continues searching Vt data. Sufficient
features can be found if a breath has a threshold number of
features that are optionally weighted by their significance, or if
a breath has a number of required features and a threshold number
of optional features, or the like. Optionally, puff identification
can be suspended during periods of activity, as indicated by input
accelerometer data, sufficient to cause puff identification to be
unreliable. Puffs and their times of occurrence are then summarized
157 by known statistical methods (e.g., totals, means, standard
deviations, and the like) to produce characteristics describing a
subject's overall smoking behavior.
[0047] Having identified a puff, the next steps determine its
morphology. Accordingly, the identified puff is searched for key
morphological features 159 such as type and volume of inhalation,
type and volume of exhalation, duration of breath holding, if any,
and the volume during breath holding, and the like. Puff morphology
is determined from the features found and statistical data is
maintained 163 on the types of subject puffs, such as average
duration and its standard deviation, percent of breath holding
time, relative tidal volume, and the like. Number of puffs of
various types, such as the above-described types, can also be
maintained. The implementation then resumes receiving input data
151 and searching it 153 for puffs.
[0048] Once sufficient data is accumulated, it is preferably
further processed. At least, it is displayed for analysis. Further,
it can be correlated with other physiological monitoring data.
Also, with reference to smoking behavior databases, prognostic
information can be estimated for the subject. Also, it can be used
as biofeedback to aid in smoking cessation or amelioration.
[0049] A number of references are cited herein, including patents
and patent applications, the entire disclosures of which are
incorporated herein, in their entirety, by reference for all
purposes. Further, none of these references, regardless of how
characterized above, is admitted as prior to the invention of the
subject matter claimed herein.
[0050] Although specific features of the invention are shown in
some drawings and not in others, this is for convenience only as
each feature may be combined with any or all of the other features
in accordance with the invention. The words "including",
"comprising", "having", and "with" as used herein are to be
interpreted broadly and comprehensively and are not limited to any
physical interconnection. Moreover, any embodiments disclosed in
the subject application are not to be taken as the only possible
embodiments. Other embodiments will occur to those skilled in the
art and are within the following claims.
[0051] In addition, any amendment presented during the prosecution
of the patent application for this patent is not a disclaimer of
any claim element presented in the application as filed: those
skilled in the art cannot reasonably be expected to draft a claim
that would literally encompass all possible equivalents, many
equivalents will be unforeseeable at the time of the amendment and
are beyond a fair interpretation of what is to be surrendered (if
anything), the rationale underlying the amendment may bear no more
than a tangential relation to many equivalents, and/or there are
many other reasons the applicant can not be expected to describe
certain insubstantial substitutes for any claim element
amended.
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