U.S. patent application number 15/358129 was filed with the patent office on 2018-01-04 for metabolic energy monitoring system.
The applicant listed for this patent is PhiloMetron, Inc.. Invention is credited to Naresh Chandra BHAVARAJU, Darrel Dean DRINAN, Carl Frederick EDMAN.
Application Number | 20180000391 15/358129 |
Document ID | / |
Family ID | 41217330 |
Filed Date | 2018-01-04 |
United States Patent
Application |
20180000391 |
Kind Code |
A1 |
EDMAN; Carl Frederick ; et
al. |
January 4, 2018 |
METABOLIC ENERGY MONITORING SYSTEM
Abstract
A metabolic energy monitoring system having one or more
physiological measurement platforms and displays enabling the
calculation and display of energy balance, kilocalorie energy
expenditure and kilocalorie intake is described. In preferred
embodiments, the system utilizes one or more on-body monitoring
platforms to enable measurement of change in body composition and
kilocalorie energy expenditure over a period of time thereby
enabling a comparator to calculate net energy balance over this
period of time and to calculate kilocalorie intake over this same
period of time. Such data may then be displayed on a display device
in wireless communication with the on-body monitoring platform to
provide the user of the system with useful information and guidance
in weight management applications.
Inventors: |
EDMAN; Carl Frederick; (San
Diego, CA) ; BHAVARAJU; Naresh Chandra; (San Diego,
CA) ; DRINAN; Darrel Dean; (San Diego, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
PhiloMetron, Inc. |
San Diego |
CA |
US |
|
|
Family ID: |
41217330 |
Appl. No.: |
15/358129 |
Filed: |
November 21, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14246549 |
Apr 7, 2014 |
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15358129 |
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12386614 |
Apr 21, 2009 |
8690769 |
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14246549 |
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61206423 |
Jan 31, 2009 |
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61134987 |
Jul 16, 2008 |
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61125140 |
Apr 21, 2008 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 5/1118 20130101;
A61B 5/4866 20130101; A61B 5/14532 20130101; A61B 5/4869
20130101 |
International
Class: |
A61B 5/145 20060101
A61B005/145; A61B 5/11 20060101 A61B005/11; A61B 5/00 20060101
A61B005/00 |
Claims
1. A method for estimating a blood glucose level of a patient, the
method comprising: estimating an energy expenditure of the patient
over a period of time; estimating a change in a body fat weight of
the patient over the period of time; using the energy expenditure
and the change in the body fat weight to calculate an energy intake
of the patient over the period of time; and using the energy intake
to estimate the blood glucose level of the patient.
2. The method of claim 1, wherein estimating an energy expenditure
of the patient includes estimating a basal or resting metabolic
rate of the patient.
3. The method of claim 2, wherein estimating a basal or resting
metabolic rate of the patient includes adjusting the basal or
resting metabolic rate to compensate for compensational changes
over extended periods of time.
4. The method of claim 2, wherein estimating a basal or resting
metabolic rate of the patient includes adjusting the basal or
resting metabolic rate to compensate for weight changes over
extended periods of time.
5. The method of claim 1, wherein estimating an energy expenditure
of the patient includes estimating an activity-related energy
expenditure of the patient.
6. The method of claim 1, wherein estimating an energy expenditure
includes using a heart rate monitor to measure a heart rate of the
patient.
7. The method of claim 1, wherein estimating an energy expenditure
includes using a thermometer to measure an ambient temperature of
an environment of the patient.
8. The method of claim 1, wherein estimating an energy expenditure
includes using a humidity sensor to measure a humidity of an
environment of the patient.
9. The method of claim 1, wherein estimating an energy expenditure
includes using an accelerometer to measure an activity of the
patient.
10. The method of claim 1, wherein estimating an energy expenditure
includes using a temperature monitor to measure a temperature of
the patient.
11. The method of claim 1, wherein estimating an energy expenditure
includes using a heat flux monitor to measure a heat flux of the
patient.
12. The method of claim 1, wherein estimating an energy expenditure
includes using a sweat measuring device to measure a sweating of
the patient.
13. The method of claim 1, wherein estimating an energy expenditure
includes using an impedance sensor to measure an impedance of the
patient.
14. The method of claim 1, wherein estimating an energy expenditure
includes using an ultra wideband radar to measure a vital sign of
the patient.
15. The method of claim 1, wherein estimating an energy expenditure
includes using inputted data of the patient.
16. The method of claim 15, wherein the inputted data includes one
or more of age, approximate weight, height, gender, lifestyles,
activity, and physical history.
17. The method of claim 1, wherein measuring a change in a body fat
weight includes using an impedance sensor to measure one or both of
a body fat index and a fluid weight of the patient at a beginning
of the period of time.
18. The method of claim 1, wherein measuring a change in a body fat
weight includes using population-based data to estimate a fluid
weight of the patient at a beginning of the period of time.
19. The method of claim 1, wherein measuring a change in a body fat
weight includes using an impedance sensor to measure one or both of
a change in the body fat index and a change in the fluid weight of
the patient at the end of the period of time.
20. The method of claim 1, wherein measuring a change in body fat
weight compensates for a change in the fluid weight.
Description
CROSS REFERENCE TO RELATED PATENTS
[0001] This application claims priority under 35 U.S.C. Section
119(e) to provisional application No. 61/125,140, filed on Apr. 21,
2008; provisional application 61/134,987, filed on Jul. 16, 2008
and provisional application 61/206,423, filed on Jan. 31, 2009.
BACKGROUND OF THE INVENTION
[0002] Obesity is defined as the abnormal accumulation of body fat
and is widely recognized as a significant contributing risk factor
in many chronic diseases. It is well accepted that people who are
obese are at significantly higher risk of heart disease,
hypertension, diabetes, arthritis, and certain cancers, and
consequently that obesity has direct impact on general health
status and quality of life. Due to obesity's central role in
determining general health and possible predisposition towards
chronic diseases, there is a significant clinical and
epidemiological need for the effective management of obesity.
[0003] In the management of obesity and diet, whether for the
purpose of improved health, disease management or for lifestyle
change, methods for the oversight of nutrition and exercise may be
based upon the relationship between kilocalorie (kcal) intake and
kilocalorie expenditure which yields a net energy balance (weight)
for a period of time (Equation 1). If the energy balance is
positive, this excess energy is typically stored within the body as
a reserve source of energy, e.g. as fat, and therefore weight is
gained.
intake (kcal)-expenditure (kcal)=energy balance (kcal) Equation
1.
[0004] By management of an individual's overall energy balance,
desired weight loss/gain or maintenance of current weight may be
achieved. To accomplish this objective, a variety of approaches
have been attempted. These include the use of kcal energy
expenditure calculators, and estimators of kcal intake. Intake
monitoring, for instance, is typically accomplished through
manually maintained diaries and/or external opinions based on
estimate average kcals contained in that food group or images of
the actual meal. These approaches are, in general, prone to
compliance or estimation error.
[0005] Alternative approaches include the use of weight scales or
body composition analyzers as indices of change in overall energy
balance (weight), however they do not provide feedback regarding
kcal energy expenditure as compared to kcal intake. In addition,
these point in time or infrequent (periodic) devices rely on user
compliance that may not accurately measure kcal energy balance.
Furthermore, the absence of information about any other factors
associated with weight gain/loss, e.g. kcal intake, significantly
limits the utility of the information as a weight management
therapy.
[0006] In short, the above approaches have proven insufficient to
adequately provide the data and solutions necessary to resolve the
terms of Equation 1 due to poor user compliance, inherent system
inaccuracies due to periodic measurements, and/or imprecision in
estimation of kcal intake. What is needed is a system that enables
determination of kcal energy expenditure, energy balance and kcal
intake, such that useful information regarding dietary habits and
kcal energy expenditure may be used to drive personalized diet and
exercise plans for an individual.
SUMMARY OF THE INVENTION
[0007] The invention described herein presents a novel system for
determining kcal energy expenditure, energy balance and kcal intake
over a period of time. Preferred elements of the system include: at
least one monitoring platform enabling the measurement of at least
one physiological parameter associated with body composition, kcal
intake, and/or kcal energy expenditure; at least one comparator
enabling the determination of energy balance from body composition
change and the determination of kcal energy expenditure, from which
kcal intake may be calculated; and at least one display enabling
the display of at least a portion of said determinations and
calculations to the user and/or other third party.
[0008] In a preferred embodiment of the present invention, an
essentially low profile and flexible monitoring platform resides in
effectively continuous contact one or more body regions and
provides physiological data for at least one comparator. The
comparator, utilizing said physiological data, in turn determines
kcal intake, kcal expenditure and energy balance and visually
presents a least a portion of said determinations by means of a
display located in a separate display unit, which may periodically
be in wireless communication with the monitoring platform. The
functions and locations of the comparator may be distributed
between the monitoring platform and the display unit in order to
better manage power, communication needs and processing circuitry
needs between the monitoring platform and display unit.
[0009] In various embodiments, the comparator may be in
communication with one or more remote data management systems, e.g.
using cell phone network communication. These remote data system(s)
may be provided with at least a portion of user data and, may in
turn supply the user with dietary guidance, suggestions, or other
forms of information. Such systems involving monitoring platforms,
display units and remote data management systems are disclosed in
U.S. Pat. No. 7,044,911, which is incorporated in its entirety by
this reference herein. Additional information including target
caloric or dietary goals, predictive trend analysis of kcal intake,
caloric expenditure and/or energy balance which may enable a user
to project when dietary goals will be reached may also be supplied
to the user. In a variation of this embodiment, a predictive
analysis is utilized by the system to automatically or upon demand
provide the user corrective instructions, alerts, support, rewards,
incentives, or other forms of information and services such that
adherence to a dietary/exercise plan or metabolic status program
may be better maintained in order to reach the desired goal. Such
information may be resident within the comparator or may be
provided by one or more remote data systems in communication with
the comparator.
[0010] In still other embodiments, notification or communication to
the user of nutritional and/or kcal energy expenditure patterns and
recommendations for improvement of eating behavior or activity may
be made in order to better achieve desired weight goals. Such
notification may be automatically generated by the comparator or
through outside parties and/or data systems in remote communication
with the comparator and may consist of audible alerts, vibrations
or other forms of communication either on the display unit or on
the monitoring platform. In yet other embodiments, the system may
provide the user access to one or more programs, counseling, and/or
materials to improve their weight management. In certain instances,
this access may be in the form of a menu from which the user
selects the desired item.
[0011] In yet other embodiments of the invention, the system of the
present invention is incorporated within a health management
program involving clinician oversight for the monitoring of body
metabolism or for the occurrence or progression of a disease
condition.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1--Illustration of one form of the present
invention.
[0013] FIG. 2--Illustration of an embodiment of the present
invention.
[0014] FIG. 3--Illustration of one embodiment of a monitoring
platform of the present invention.
[0015] FIG. 4--Illustration of one embodiment of a monitoring
platform indicating removable circuit element.
[0016] FIG. 5--Graph representing the observed relationship between
body fat index and regionally measured bioelectric peak phase
angle.
[0017] FIG. 6--Illustration of the display in one embodiment of the
present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0018] The invention generally relates to a novel system for
improved weight management. The method of the system is comprised
of the automatic determination of an individual's energy balance,
preferably based upon measured change in body composition, and the
individual's kcal energy expenditure which enables the subsequent
calculation of the individual's kcal intake over a period of time.
The invention further claims the use of said determined terms
(balance, expenditure, intake) and factors derived from these terms
for use in the management of diet and metabolic status-related
health issues. In selected embodiments, one or more weight
management tools may be selected by the user and/or automatically
generated by algorithms associated with the system to further
enable weight management goals. In addition, the present invention
also may include the display, storage and transmission of said
determined terms within a local or distant environment.
[0019] The system, in various embodiments, may use one or more
measured physiological parameters to determine the caloric
expenditure, kcal intake and energy balance status and from these
values, to assist the users in modifying food intake and exercise
in order to meet their targeted weight and body composition goals.
The information provided to the user or other authorized third
parties in these applications may include the current measured
parameter status, and/or derived variables from measured/collected
data such as trending or prediction when a predetermined threshold
value will be exceeded. In other readily conceived embodiments, the
system may be utilized for non-weight management applications, e.g.
readiness or fitness monitoring of military personal and first
responders, geriatric monitoring for activity and metabolic health,
nutritional status monitoring, chronic disease monitoring, and
possibly for use in analyte quantification such as glucose
monitoring/disease treatment assessment. Accordingly, additional
uses of the present invention are readily conceivable and the scope
of the present invention is not limited to those applications
presented herein.
[0020] An illustration of one form the present invention is shown
in FIG. 1. As shown, system 100 consists of monitoring platform
110, in substantial contact with measured body 105. Display unit
130 has visual display 132, and comparator 120, represented by
dotted line structures, is shown to reside on both monitoring
platform 110 and display unit 130. Also shown is solid arrow 140
representing communication of information, instructions or data
between monitoring platform 110 and display unit 130. Such
communication may be by wireless, e.g. radio transmission, or
direct connection means. Also shown is dashed arrow 150
representing communication between display unit 130 and one or more
remote data management locations 160 which may provide additional
information or data of use to the user.
[0021] According to the method of the present invention, monitoring
platform 110 measures one or more physiological parameters of body
105 associated with body composition or kcal energy expenditure.
Such sensed parameters may include change in tissue composition,
analytes and/or fluid status. In preferred embodiments, the data
from one or more measurements of one or more body regions is
correlated through use of algorithms by comparator 120 to estimate
change in overall body composition. Additional measurements of
other physiological and/or anthropometric parameters, e.g. motion,
enable determination of kcal energy expenditure of the body.
[0022] The comparator 120 also enables the storage and mathematical
manipulation of said received information to determine kcal intake
over a period of time, e.g. through employment of Equation 2.
expenditure (kcal)+energy balance (kcal)=intake (kcal) Equation
2.
[0023] The calculated kcal intake, kcal energy expenditure and/or
energy balance may then be presented to the user through use of
display 130 either automatically or upon demand by the user.
[0024] The comparator 120 may also, in certain embodiments,
transfer, 150, the collected data sets or information regarding
energy balance, kcal expenditure, kcal intake, nutrition or other
user characteristics (trends, anomalies) to a remote data
management system, 160, having additional data storage and
comparator functions, for additional analysis. Such transfer 150
may be by wireless or wired means, e.g. cell phone networks,
ethernet communication using the internet linkages, etc. Data
management system 160 may provide useful feedback to the user upon
analysis of said received data, e.g. through display 130, on
suggested modifications of diet, exercise or lifestyle in order to
assist the user reaching their weight management targets or
maintain their current energy balance (weight). In certain
embodiments, trends in user data may initiate preemptive
recommendations to the user by either comparator in order to
mitigate or alter predicted trend outcomes.
[0025] A preferred embodiment of the present invention for the
purpose of weight management applications (lose and maintenance) is
presented in FIG. 2. As shown, monitoring platform 210 is
constructed to be substantially low profile (planar) and flexible
and is affixed to body 205, at a selected body region, e.g. by
means of adhesive. A patch-like monitoring platform enables
possible advantageous use, e.g. enabling measurements while wearing
clothing and/or ambulatory use as well as possible lowering
compliance for effective employment of the system on the part of
the user. A patch-like sensor also may advantageously enable
measurements to be obtained from a single body region for extended
periods of time, e.g. hours, days, weeks. Furthermore, effective
constant contact with a single body region may advantageously
afford consistency of measurements to a defined body region thereby
potentially reducing unwanted variability in measured data sets
taken over time due to location shift, and thereby possibly
enabling a more precise determination of compositional changes
occurring in the measured body region as compared to measurements
taken by serial application of the measurement platform.
[0026] In order to accomplish said measurements, monitoring
platform 210 has support structure 212, controlling circuitry, 214,
power, e.g. battery, 216, and transmission antenna 218. Sensor
elements 220 include a plurality of electrodes for conducting
regional multifrequency bioelectrical impedance measurements for
possible use in body composition determination, temperature
sensors, e.g. thermistors, to aid in body composition and kcal
energy expenditure determinations, at least one multidimensional
accelerometer for possible use in kcal energy expenditure
determination, and electrodes for the measurement of heart rate,
also for possible use in kcal energy expenditure determination. In
a variation of this preferred embodiment, at least some of the
electrodes utilized for bioelectric impedance measurements may be
those employed for the measurement of heart rate and respiratory
rate. Not shown are necessary interconnects (wires) providing
electrical connections between components and structural
layers/materials providing additional layers to overall structure
210.
[0027] In further detail, controlling circuitry 214 has elements,
e.g. microcontroller, memory, amplifiers, radio transceiver
(transmission/reception) chipset, analog to digital converters,
digital to analog converters, switches, clock crystal, etc.,
necessary for obtaining measurement data from sensors, processing
said data, e.g. signal noise removal and conversion to values
useful for subsequent analysis, and transmission of said data. Such
signal manipulation and conversion into useful data represents at
least a portion of the comparator's activity which may be residing
on the monitoring platform. Such circuit elements may be
constructed from discrete circuit components, e.g. resistors,
operational amplifiers, microcontroller, or may be comprised of
multifunctional components such as application specific integrated
circuits (ASICs) or combinations of these elements. Such elements
may also be constructed of conventional silicon-based (CMOS)
circuit elements or may utilize in part or in whole, printed
electronic and/or advanced nanoelectronic elements thereby enabling
possibly improved platform flexibility as compared to silicon-based
elements.
[0028] As shown in FIG. 3, the structure of the monitoring platform
300, shown in a side view with layers separated as indicated by
arrows, may be comprised as a multilayered essentially low profile
(planar) structure having at least three principal layers. A first
layer 310, or bottom layer, has a first surface 312 enabling
substantial contact with body and may include sensor elements, e.g.
electrodes, 314. This layer may also include one or more
biocompatible adhesives 316 to promote adherence of the monitoring
platform to the body. A second or middle layer, 320, comprises the
location of necessary circuitry, e.g. an electronics layer, having
circuitry elements 322 necessary for monitoring platform
functionality mounted on a preferably flexible substrate 324, e.g.
polyimide or other suitable material. In preferred embodiments,
such electronic components are constructed such that such elements
are contained within the overall structure of the monitoring
platform. A third, or upper layer, 330, may be comprised in large
part of a protective covering 332 to minimize possible moisture
contamination of underlying circuitry and sensors. In addition, the
upper layer may be constructed in part of a foam material, 334,
enabling improved comfort to the user. In related embodiments, the
upper layer may also include one or more display elements, e.g.
organic light emitting diode (OLED) display, and/or contain a logo
or pattern relating to commercial or marketing purposes. The upper
layer, 330, may also contain a visual indicator, e.g. light
element, to confirm that the device is operating properly or has
experienced an error condition.
[0029] In related embodiments, portions of circuitry elements may
be constructed as a removable, replaceable circuit "puck" or
structure, thereby possibly lowering overall cost of monitoring
platform use. One such an embodiment is shown in FIG. 4 wherein
monitoring platform 400 has a substantially low profile (planar)
lower structure 403 containing battery 435, sensor 430, electrical
traces 425, circular electrical contacts 420 and retaining clips
423 and substantially low profile (planar) upper covering structure
405. Insertion of circuit puck 410 containing circuit elements 415
between lower structure 403 and upper structure 405 thereby enables
contact between circuit puck electrical contacts located on puck
410 surface to opposing electrical contacts 420 (puck 410
electrical contacts not shown). Use of circular contacts 420 is
advantageous by minimizing need for orientation requirements for
correct insertion of circuit puck 410. Other geometries and forms
of circuit puck structure and means of electrical contact are
readily conceivable, e.g. optical interconnects, oblong shaped
pucks, etc. and the scope of the present invention is not limited
to the structure presented in FIG. 4.
[0030] Returning to FIG. 2, communication between monitoring
platform 210 and display unit 230 in this preferred embodiment is
by wireless methods, e.g. through the use radio wave communication
such as Bluetooth.RTM. or other commonly employed radio
communication means. In this preferred embodiment such
communication has limited range, e.g. less than 10 meters, and may
be encrypted to prevent unwanted access to transmitted data sets,
etc. In other embodiments, communication between the monitoring
platform 210 and display unit 230 may utilize long range radio wave
communication such as cellular, WiFi, WiMax or other radio
communication means with distances longer than 10 meters. Such
communicated data may also include identifiers identifying all or a
portion of the overall monitoring platform 210, e.g. circuitry 214
and/or sensors 220, such that tracking of these elements maybe
enabled for a variety of useful purposes, e.g. the linking of data
sets to an individual user in a larger data collection/analysis set
or the tracking of manufacturing performance/reliability. In
occasions where communication between monitoring platform 210 and
display unit 230 is unobtainable, sensor data may be stored for a
period of time, e.g. up to 24 hours, until communication is
restored and sensor data may be transmitted to display unit
230.
[0031] Display unit 230 has functionalities enabling further
comparator activities and conveyance of comparator
information/analysis to the user such as display 232. Such
functionalities (not shown) include circuitry elements, e.g.
microcontroller, memory, battery, one or more transceivers and
associated antenna, etc. and are well known to those skilled in the
art of electronics. In certain forms of this preferred embodiment,
the display unit is comprised of a cellular phone having necessary
comparator software included to enable dual function as both a cell
phone and as a display unit. The display unit may dynamically
distribute the comparator functions between the monitoring platform
210 and display unit 230. This dynamic comparator function
distribution may be adjusted based upon power supplies remaining,
wireless communications link quality, measure physiological
parameter rate of change or similar physiological, environmental or
system elements.
[0032] Within comparator, mathematical functions, e.g. algorithms,
enabling the determination of compositional change, and the
resultant energy balance associated with this compositional change,
kcal energy expenditure and kcal intake are present. Such
algorithms may include additional information, e.g. user data such
as age, gender, and/or body dimensions such as height, waist or hip
size that may be input by the user or others and useful to
algorithm function and comparator analysis. Such data may be input
in response to queries on the display unit as part of comparator
function, input through keyboard or voice recognition functions
located in the display unit or input through the remote data
management system 250.
[0033] Also shown in FIG. 2 is communication between display unit
230 and remote data management system 250. Such communication may
involve wireless methods, e.g. through cell phone networks,
combined with internet forms of communication in this preferred
embodiment. At remote data management system, 250, additional
analysis of user data may be performed and responses providing
instructions, recommendations, support, services, etc. to better
enable the user to manage weight management objectives sent back to
back to display unit for the user's review.
[0034] Further details regarding each of the elements of the
present invention are presented below.
[0035] Monitoring Platform--
[0036] The monitoring platform consists of one or more sensors
enabling the measurement of physiological parameters that are
useful for the calculation of body composition, energy balance,
kcal intake and kcal energy expenditure.
[0037] Body region(s) to be measured for the purpose of body
composition change determination are preferably those enabling
correlation to one or more measurements to changes in total body
composition. More preferably, these measured regions comprise only
a portion of a larger body structure, e.g. a regional measurement
of a portion of the abdomen, as compared to a measurement spanning
the entire torso, e.g. shoulder to hip, or extending between two
extremities, e.g. leg to leg measurements. In addition, a selected
region preferably enables assessment of change of one or more body
composition elements e.g. body fat, body fluids, lean mass.
Examples of such regions may include regions of the lower chest,
abdomen, upper thigh or other body regions having significant
storage of body fat responsive to changes in kilocalorie intake and
expenditure.
[0038] In certain embodiments, one or more body regions may be
selected as the optimal placement/measurement site based upon
sensitivity of a body region to body composition change within a
particular demographic group, e.g. gender, age, overall fitness
(lean, normal, overweight, obese) or co-morbidities such that one
group of individuals, e.g. adult males, may have a recommended
placement location differing from those of a different group, e.g.
adult females. Accordingly, the scope of the present invention is
not limited to one body location or region.
[0039] In general terms, sensors for assessing body composition
involve the exchange of one or more energies with a body region in
order to enable the assessment of the composition of the body
region. Such energies have in general the useful property of being
differentially affected, e.g. differentially absorbed, by different
tissue types and therefore analysis of signals from such sensors
may be utilized to determine changes in the tissue composition
through which the signal traverses.
[0040] Such sensors may include electromagnetic, electrical,
optical, mechanical or acoustic energies and the scope of the
present invention is not limited to any one form or type of sensor.
These sensors may measure the composition, change in composition or
utilize an introduced element e.g. nanopartical, photoresponsive
agent, etc. to assist in these measurement activities. In a
preferred form of the present invention, one or more bioelectric
impedance sensors utilizing one or more frequencies generally in
the range between 1 kHz and 1000 kHz, most preferably in the range
between 1 kHz and 200 kHz, are utilized in the determination of
body composition in one or more body regions. We have
advantageously observed that regional multifrequency bioelectric
measurements obtained on the lower chest/abdomen enable
measurements useful for determination of factors associated with
body composition and therefore useful in the system of the present
invention. Such regional bioelectric impedance measurements may be
adventitiously obtained using electrodes positioned in a single
structure, e.g. a patch, and therefore do not require the use of
wires or separate monitoring platform structures to conduct body
composition measurements.
[0041] For example, FIG. 5 presents raw bioelectric impedance peak
phase angle data obtained from such regional such regional
multifrequency bioelectric impedance measurements correlated to the
body fat index of multiple individuals, as measured using the
published U.S. Army's body fat index algorithm. As shown by
correlation line 510, there exist a significant inverse correlation
between the bioelectric impedance peak phase angle and the body fat
index, with a slope of -0.4 and correlation coefficient of R=0.7,
thereby demonstrating general capability of measurements obtained
at a body region to be correlated to body fat percentage and by
extension to overall body composition. Scatter in the observed data
set may be reduced and the correlation improved by the inclusion of
additional factors such as gender, age, body dimensions, etc. by
multiple regression or other forms of mathematical analysis. Such
methods and approaches to improve correlations are well known to
those skilled in the art of mathematics and body composition
analysis.
[0042] In addition, sensors for determining body composition
(and/or kcal energy expenditure) may be invasive, e.g. implanted.
Alternatively, sensor measurements may be substantially
non-invasive, e.g. through the use of electrode-type sensors in the
case of impedance measurements located on the skin surface. In
still other forms of the invention, completely non-contact forms of
measurement may also be utilized for the determination of body
composition (body fat, fluids, lean mass), analytes, kcal
expenditure, or metabolic status. Examples of such forms of
measurement include the use of ultra wideband radar where the
exchange of one or more energies does not require direct contact
with a body surface. Such ultra wideband frequencies, generally in
the range between 2 GHz to 10 GHz, may provide penetration into
several centimeters within body tissues and thereby may enable
determination of body composition within the inspected region.
[0043] In yet other embodiments, sensors to measure one or more
analytes possibly reflecting change in body composition, metabolic
status or activity may be utilized either alone or in conjunction
with other sensors to aid in the determination of changes in body
composition, kcal expenditure, kcal intake or temporal data. Such
sensors may include those for circulating hormones such as leptin
or insulin, interstitial glucose, circulating lactate, circulating
vitamins, exhaled ketones, exhaled carbon dioxide, nervous activity
such as sympathetic nervous activity, or sensors enabling the
determination of perspiration amount, composition or rate. In
related embodiments, additional sensors responsive to related
metabolic parameters may be included. Sensors may also include
sensors reflective of long-term metabolic changes, e.g.
glycosylation of blood hemoglobin, blood pressure or urine protein
concentration. In form, said sensors (and monitoring platforms) may
comprise structures integrated with one or more other sensors or
serve as stand-alone, e.g. glucometer, sensors. Said sensors may be
constructed in a variety of fashions, e.g. optical, electrical,
chemical, acoustic, and utilize materials employing conventional
silicon-based electronics to nanostructures to combined
biological/inorganic structures, e.g. genetically engineered cells
responsive to the presence of one or more analytes. The form and
scope of the present invention is not limited to any one form or
type of analyte sensor.
[0044] In still yet other embodiments, one or more sensors
inspecting one or more body regions having same or different forms
of energies may be employed to enable determination of body
composition, body composition changes or metabolic status. In
related forms of the invention, sensors useful for the
determination of body composition changes may also utilize sensor
data from other forms of body measures, e.g. weight scales, or
specific gravity/buoyancy determinations, to aid in the overall
analysis.
[0045] In addition to sensors for body composition determination,
the method and system of the present invention may also employ one
or more sensors for the determination of kcal energy expenditure.
In general terms, these sensors are responsive to kcal energy
expenditure of the body relating to activity. Data from such
sensors may be employed in algorithms also incorporating
estimations of basal/resting metabolic rate and/or other
non-activity related forms kcal energy expenditure by the body,
e.g. digestion, in order to determine overall kcal energy
expenditure for a period of time.
[0046] In a preferred embodiment of the invention, sensors enabling
the determination of kcal energy expenditure associated with
activity, e.g. determination of heart rate, activity and core body
temperature, are located in the same monitoring platform as those
sensors employed for the determination of body composition. Forms
of such sensors may include electrodes or optical means, e.g. pulse
oximetry, for the determination of heart rate, multidimensional
accelerometers for activity and thermistors or heat flux sensors
for the determination of core body temperature. In general, the use
of activity sensors and energy estimation are well known to those
skilled in the art of activity measurement and, accordingly, other
forms and type sensors may be employed in this regard and the scope
of the present invention is not limited to one form or type of
activity sensor.
[0047] One or more of the sensors utilized for kcal energy
expenditure may also be utilized for body composition
determination. For example, sensors enabling ultra wideband radar
measurements for body composition determination may also be
advantageously employed for the determination of heart rate and/or
respiration rate to provide useful data for kcal energy expenditure
determination. Data used for these respective analyses may be the
same data sets or different. For example, regional ultra wideband
radar data utilized for kcal energy expenditure determination may
employ time-based measurements, such as to enable heart rate and/or
respiration determination, whereas static or non-rate based data
may be utilized for determination of the composition of the
underlying tissue and therefore useful for body composition
determination.
[0048] In alternate embodiments, sensors for kcal energy
expenditure may directly correlate to the overall sum of body kcal
energy expenditure, i.e. these may relate directly to overall
metabolic (kcal) rate/expenditure. Such sensors may be those
associated with indirect calorimetry of the body and may include
those for measurement of inhale and exhaled gases, e.g. carbon
dioxide exhalation relative to ambient (inhaled) levels of oxygen
and carbon dioxide, or core body temperature sensors.
[0049] Sensor measurements may also be taken with varying time
periods (duty cycle) commensurate with desired measured parameter,
e.g. the pattern, level, or rate of activity and/or body
composition status change. An example of this may be that of an
activity sensor utilizing a sleep mode employing infrequent
measurements, e.g. once every 10 or 30 minutes, then transitioning
to an active mode, e.g. once every several seconds or few minutes,
in response to a sudden change in activity or motion. As activity
may vary more frequently than the rate of body composition change,
the measurement duty cycle of sensor measurements for activity
and/or body kcal energy expenditure determination may differ than
those employed for measurement of regional composition change over
a period of time.
[0050] In general form, monitoring platforms, in addition to one or
more sensor elements delivering energy to or receiving energy from
a body region, e.g. impedance electrodes or accelerometers, also
contain electronic circuitry necessary to the proper function of
the sensor(s). As such, the electronic circuitry may include:
memory, microcontroller and/or digital signal processor, analog to
digital converter, digital to analog converter, amplifiers and
power (battery), as well as a means of communicating sensor data to
one or more comparators for analysis and subsequent display. Such
communication may be wireless or wired, e.g. through radio
transmission or by direct connection as part of a larger circuit
assembly. In certain instances, the circuitry utilized for one or
more sensors, e.g. ultra wideband radar, may be utilized at least
in part for communication of sensor data. In general, the design
and construction of sensor circuitry are well known to those
skilled in the art of electronics and, accordingly, other forms and
type sensors may be employed in this regard and the scope of the
present invention is not limited to one form or type of sensor
circuitry. The monitoring platform may include automated activation
through means such as the closing of an electrical contact,
installation of a battery, exposing a photocell switch located on
the platform to light, etc. In other forms, the display unit may be
used to fully activate the monitoring platform from a sleep mode.
This may be accomplished through a variety of means, e.g. through
wirelessly transmitted instructions or through direct contact-based
approaches, e.g. by use of one or more conductive elements relaying
electrical signals to the monitoring platform.
[0051] In form, the sensors and monitoring platforms for body
composition and/or kcal energy expenditure determination may be
configured in a variety of fashions and the scope of the present
invention is not limited to any one form of monitoring platform.
For example, sensors may be implanted within the body, affixed
directly to the skin surface, handheld, incorporated into articles
of clothing, or be affixed to furniture, bedding, or attached to
walls. In related embodiments, sensors of the present invention may
be incorporated into medical devices having additional functions
beyond those associated with the present invention.
[0052] As an example of handheld embodiment of monitoring platform,
sensors may be incorporated into a handheld device also having
comparator and display functionalities, e.g. within a suitably
configured cell phone. In such form, sensors such as ultra wideband
radar may be enabled and utilized by periodic placement of the
sensors at selected body sites, e.g. against the lower chest, to
provide data suitable for determination of body composition and
incorporation of sensors for activity, e.g. accelerometers, within
the body of the device which is intended to be worn when not in
use.
[0053] In yet other embodiments, the monitoring platform(s)
enabling measurement of body composition are different and
physically separated from the monitoring platform (s) for
measurement of kcal energy expenditure. Examples of such multiple
platforms include use of pedometers or other activity sensors
combined with one or more patches affixed to the body enabling
measurements of body composition.
[0054] Comparator--
[0055] A preferred function of the comparator is the determination
of kcal energy balance, kcal expenditure and kcal intake
corresponding to a period of time, e.g. hours, days or weeks. Such
determination is accomplished through the use of monitoring
platform data and input setup data, preferably according to the
mathematical formula presented in Equation 2. It is understood that
the use of kcal as energy for the purpose of calculation (and
display) may be substituted for by other forms of energy unit, e.g.
joules, and/or alternative forms of energy units, e.g. conversion
of kcal to "cupcake" units and/or points and therefore conveyed to
the user in this form, e.g. 3 cupcakes, or 3 cupcakes=7 points, to
enable improved understanding and compliance to dietary regimens.
Accordingly, the scope of the present invention is not constrained
any one form of energy unit.
[0056] The location of the comparator functions may reside in part
or in whole in electronic components located in a monitoring
platform, a display unit, or in one or more remote data management
systems and the system of the invention is not constrained to one
location/structure for comparator activities. The dynamic
allocation of the comparator functions may be controlled by the
monitoring platform, display unit or remote data management system
or a combination of these system elements.
[0057] At least two platform sensor data sets are preferably
employed in order to accomplish the assessment of metabolic kcal
parameters according to the use of Equation 2, e.g. at least one
data set measured at the beginning of the specified period of time
and at least one data set measured end of this period of time. Such
data sets may also include a plurality of data obtained in
intervening intervals within this time period. Accordingly, in such
embodiments, the comparator may instruct or otherwise engage with
the monitoring platform in order to accomplish the sensor
measurements and receive the corresponding data sets. Such
communication may include upon demand instructions issued by the
comparator to the monitoring platform, or receipt of data sets from
the platform taken on a preprogrammed basis by the monitoring
platform. In other embodiments, projected or anticipated data sets,
e.g. anticipated activity based upon past patterns of activity
and/or energy balance/body composition trends may be substituted
for one or more measured data sets. Accordingly, the scope of the
present invention is not confined to any one form of instruction or
method for obtaining said data sets to be used in this
assessment.
[0058] In general, algorithms employed by the comparator for the
determination of energy balance and kcal energy expenditure, kcal
intake may utilize data such as user age, gender, height, fitness
level, starting waist diameter and initial starting weight, to
enable improved correlation of one or more regional measurements to
overall body compositional change and/or net kcal energy
expenditure. In certain other embodiments, other information, e.g.
user or clinician inputted data such as co-morbidities, blood test
results, stress test results, etc., or additional population-based
data may also be included in one or more algorithms to improve
determination sensitivity. In still other forms of the invention,
baseline parameters are established from one or more measurements
such that change or trends from this baseline(s) may be determined
and employed in subsequent calculations and estimations of energy
balance, calorie intake, etc.
[0059] In certain embodiments, it may not be advantageous to
calculate and/or present findings associated with immediate or
current status of the user. That is, such estimations do not
necessarily incorporate newly ingested food or nutrients and
therefore, in certain embodiments, an offset period of time, e.g.
minutes or hours, may be utilized to enable distribution of
ingested nutrients throughout the body prior to calculation and
display.
[0060] In yet other embodiments, one or more algorithms employed
for determination of energy balance and/or kcal expenditure are
dynamic in that one or more parameters within said algorithms may
be automatically (or manually) adjusted through use of one or more
correction factors or terms inputted over time, e.g. adjustment of
terms utilized in the calculation of basal metabolic rate to
compensate for change in rate associated with weight loss. In
related embodiments, such adjustments may include self learning or
self adjustment of algorithms in response to one or more received
inputs or data sets.
[0061] Kilocalorie Energy Balance
[0062] In preferred embodiments of the invention, energy balance is
determined from a change in body composition wherein said change in
body composition is mathematically converted to corresponding
energy balance (kilocalories) associated with this change. For
example, if a net increase in fat of 100 g was determined, this
increase may be converted to a net gain of in overall energy
balance of 900 kcal using a conversion formula, e.g. 1 g fat
representing approximately 9 kcal of energy.
[0063] As a preferred method of determining body composition
change, the body is considered to be divided into two major
compartments: body fat (BF) and fat free mass (FFM). As water
content comprises .about.60% of total body weight but is assumed to
provide negligible contribution to the mass of fat (<2%), this
observation enables the further segregation of FFM into two
compartments: fluid (H) and other tissue mass (O) wherein O is
comprised in part of components generally assumed to reflect the
other major sources of energy within the body--lean mass--comprised
of protein, e.g. muscle, and complex carbohydrates, e.g. glycogen.
The remaining portion of O, e.g. bone mass, is generally considered
to be invariant and non-contributing under most metabolic analysis
situations. Change in the masses of protein and complex
carbohydrate may in turn be converted to the overall energy balance
through the use of additional conversion formula, e.g. both protein
and complex carbohydrates approximately represent 4 kcal/g. From
these observations, determination of change in body fat mass (BF)
and other tissue mass (O) thus enables determination of overall
energy balance.
[0064] Change in BF and O or components of O reflecting change in
body composition and, by extension, energy balance may be derived
by a number of methods and the scope of the present invention is
not constrained to any one form or method. For example, change in
BF and O may be accomplished through use of Equation 3 where BFI
indicates the body fat index (or body fat percentage) of an
individual. As general approach, the terms of Equation 3 may be
determined for the initial period of measurement and subsequently
at the completion of a selected time period. These two
determinations thereby enabling subtraction of the initial
determined values of BF and O from the final (or end of time
period) values of BF and O, thereby providing the overall change in
BF and O. From the change in BF and O (represented as grams or
other units of mass), the energy (kcal) corresponding to these
changes may then be readily determined using conversion formulas,
e.g. fat=9 kcal/g and O (protein and carbohydrates)=4 kcal/g.
BFI = BF TotalBodyMass = BF H + BF + O . Equation 3
##EQU00001##
[0065] In preferred solutions to Equation 3, determination of BFI
at the start and end of a period of time in conjunction with the
determination of change in H over this period of time enables
estimations of change in BF and in O, without requiring intervening
or multiple weight measurements. Sensors enabling determination of
BFI and H change include regional bioelectric impedance sensors
wherein the resultant impedance signal is analyzed for both fluid
change and body composition (BFI). Specifically, we have
advantageously observed that regional bioelectric impedance
resistance and reactance terms may be employed in the estimation of
systemic fluid change whereas impedance phase angle terms, such as
peak phase angle of multifrequency bioelectric impedance
measurements, may be correlated to BFI, such as represented by data
presented in FIG. 3. Utilizing these data as an example, the slope
of the correlation line (S.sub.BFI) relates the sensitivity of the
change in phase angle (.phi.) to change in BFI (Equation 4).
S BFI = .differential. .phi. .differential. ( BFI ) = - 0.4 .
Equation 4 ##EQU00002##
[0066] In general terms, the smallest detectable change in
bioelectric impedance phase angle enables the most sensitive
determination of BFI change. The resolution of phase angle is
governed by multiple factors including circuit sensitivity, number
of replicate measurements, and overall signal impedance. In
addition to phase angle measurements, other factors such as age,
gender, lifestyle, fitness estimate, ethnicity, initial waist size,
etc. may be employed in an algorithm to improve correlation between
phase angle and BFI. From such inputs, an algorithm relating
impedance phase angle to BFI and therefore enabling the tracking of
BFI change over time may then be constructed. Likewise, algorithms
for the determination of hydration change from bioelectric
measurements can also be constructed and methods and devices for
hydration change assessment are described in U.S. patent
application Ser. No. 10/922,370, which is incorporated in its
entirety by this reference herein. In general, such approaches may
be employed with other forms of sensors enabling the relating of
one or more regional measurements to a systemic physiological
parameter e.g. body composition.
[0067] In this preferred embodiment, a first estimate of starting
body mass or weight is utilized such that the initial fat mass BF
may be better determined. However, since in this embodiment, the
change in the components of body composition, e.g. change in BF, H
and O, are utilized for subsequent use in determination of energy
balance, small errors in the accuracy of inputted starting weight
and overall fluid mass H do not significantly affect subsequent
calculation of changes in the noted parameters.
[0068] By way of explanation, it is the accuracy of the estimation
of the amount of change which is more critical to the solution of
this embodiment rather than the true accuracy of the absolute
masses, e.g. it is more important to determine that the change in
fat is 100 g and not whether the starting fat mass was 24 kg or
24.5 kg and the resultant ending fat mass was 24.1 kg or 24.6 kg,
respectively. A similar argument applies for the initial estimation
of fluid H in individuals. In general, in lean individuals, H may
comprise 60% of total body mass, whereas in fat individuals, H may
comprise 55% or less. However, change in H for subsequent
measurements contributes to overall assessment of BF and O as
during the course of a day, this value may shift appreciably, e.g.
several liters (or kgs), due to fluid intake and loss (urination,
sweat, transpiration, etc.) whereas it is difficult for most
individuals to substantially loss more than 0.1 kg of fat within
this relatively short period of time. Therefore estimation of the
change in H improves the overall sensitivity of the determination
of the change in BF and O.
[0069] Equation 3 may then be solved for the initial or starting
point of the time period by inputting sensor data corresponding to
BFI and establishing a baseline fluid status, H. An estimation of
starting weight may be utilized for establishing H in conjunction
with population based formulas of percentage hydration
corresponding to individuals of that BFI. From these initial
parameters, the initial starting fat mass BF may be determined,
e.g. using the form of Equation 3 utilizing total body mass in the
denominator and BF in the numerator then equated to BFI. The
initial starting O mass may in turn be determined by utilizing the
alternate form of Equation 3 having the terms F, H and O in the
denominator, BF in the numerator, and equated to BFI and solving
for O upon substitution of the other terms, including a baseline
fluid status H.
[0070] At the end of a selected period of time, solutions of
Equation 3 for use in determining change of BF and H from initial
values may be arrived at in multiple fashions. In a preferred
method, sensor data corresponding to this end period is utilized to
determine a new BFI corresponding to this end of period (EOP), e.g.
BFleop. Sensor data may also be used to provide data enabling
change in H over this period of time to be determined, e.g.
Hchange. Utilizing this determined Hchange and the initial estimate
of H, a new H (Heop) may then be calculated by addition of Hchange
to H. The BFleop and Heop may then be employed in solving Equation
3 for terms of BF and O representative of the end this period time,
e.g. BFeop and Oeop, respectively.
[0071] A preferred method for the determination of BFeop and Oeop
is accomplished through a calculation process which includes
reiteratively substituting in calculated BFeop values to determine
estimates of Oeop and then employing these estimates of Oeop to
arrive at further estimates of BFeop, and so on. This substitution
process may be continued until convergence, e.g. no change, is
observed in values of Oeop and BFeop.
[0072] An alternative is the calculation of BFeop without the
simultaneous calculation of Oeop, e.g. by use of Equation 3,
BFleop, and adjusting the initial starting weight estimate by H
change, and then estimate Oeop. One method for the estimation of
Oeop would be to utilize results from population-based studies
providing insight into the proportional loss of protein or lean
mass associated with a loss of fat mass. That is, typically during
dieting, approximately 70% of weight loss is associated with fat
loss and 30% due to a combination of protein and carbohydrate loss.
Such relationships may be employed to provide estimates of the
change in O from which Oeop may be readily determined.
[0073] A yet additional method would be to consider only BF as the
only parameter of interest, e.g. since fat has the highest caloric
content per gram weight and is typically the focus of weight loss
programs. By way of example, consider a 100 kg individual with a
BFI of 25%. This BFI corresponds to a fat mass BF of 25 kg. At a
second point in time, e.g. 1 or 2 days from the first
determination, assume that the individual weights 101 kg, of which
0.9 kg represents added fluid (H change) and 0.1 kg in added fat
mass representing a new BFI of 24.85%. The assessment of the added
fat mass may be estimated according to one embodiment of the
present invention through the use of measured H change and BFI
measurements. That is, by use of one or more sensing methods, e.g.
through the use of regional multifrequency impedance measurements,
the gain in fluid may be determined. From this gain in fluid, an
overall weight may be calculated to be 100.9 kg (as compared to the
"true" 101 kg weight). A new BFI of the individual may also be
determined through measurement, e.g. by use of bioelectric
impedance phase angle measurements. As the phase angle measurement
may be correlated to population-based assessments of BFI,
independent of H, the measured BFI would be 24.85% (or within an
error arising from the applied measurement technique). Calculating
fat mass BF from the measured BFI of 24.85 and the assumed weight
of 100.9 kg yields a value of BF of 25.07 kg or 0.03 kg from the
"true" value. As the ability to gain or lose body fat mass is much
less than the possible fluctuations associated with H over a
relatively short period of time, e.g. days, such errors may be
acceptable in many applications, as this error represents a
fraction, e.g. 10%, of daily calorie intake.
[0074] In addition, from these calculations enabling determination
of changes in the various body compartment masses, a new overall
body weight estimate may be made and employed in subsequent
measurements and analysis. This process may be further tailored to
the individual by the use of periodic inputs of other parameters,
e.g. weekly, weight scale measurements to provide further
calibration of algorithm variables employed in the analysis.
[0075] Alternatively, Equation 3 may be solved and utilized in the
above fashion through the inputting body weight into the comparator
on two or more separate occasions, and providing to the comparator
sensor data correlating to BFI on these occasions. The comparator
may then utilize this information to first derive BF and
subsequent, through substitution, derive an estimation of O while
assuming H invariant. However, this embodiment and/or related
embodiments may be adversely affected by body composition
determination errors associated with non-compositional weight
change resultant from fluid (hydration) change affecting the
estimation of H and/or dietary/voiding patterns affecting
estimation of total body weight or inaccuracies associated with
temporary monitoring platform placements.
[0076] In preferred embodiments, a plurality of measurements
intended for body composition analysis are taken over relatively
short periods of time, e.g. seconds or minutes, such that these
determinations themselves may be averaged to reduce uncertainties
associated with measurement accuracies, e.g. signal noise
attributable to motion artifacts and assuming that the body
parameter, e.g. BF, is considered invariant during this short
measurement period. These measurements in turn may be employed
within larger time periods enabling determination of body
composition change.
[0077] In still other embodiments of the invention, less frequent
measurements may be employed, e.g. through the use of handheld
monitoring platforms periodically used throughout the day. These
measurements may employ one or more measurement technologies and/or
one or more body sites for supplying desired data. In addition, in
these as well as other embodiments of the invention, additional
sensors, e.g. heart rate, respiration, temperature, etc., or sensor
measurements themselves may be employed to adjust the obtained
measurements to minimize signal noise, position or motion
artifacts.
[0078] In short, there exist multiple approaches for the
determination of body composition change and/or energy balance and
the scope of the present invention is not constrained to any one
form or method of solution.
[0079] In still other forms of the invention, measurements of one
or more parameters reflecting an underlying physiological trait,
e.g. serum glucose levels, may be combined to form a more complete
indication of the overall metabolic status of an individual. These
assessments may be useful in the adjustment one or more parameters
within the comparator, e.g. basal metabolic rate estimation and/or
body composition change associated with intake, to further tailor
the described algorithm to the individual. These measured
parameters may reflect both short term and long term status of the
underlying physiological trait examined.
[0080] In addition, these measurements may provide insight into
dietary patterns or habits not necessarily resultant in immediate
body compositional change but possibly useful for guidance,
instruction, etc. For instance, serum glucose levels typically rise
then fall in response to ingestion of food over a period of time,
e.g. minutes to hours. The pattern, duration and magnitude of such
rise and fall may provide useful insight into the nature and
amounts of food consumed and may be monitored by means of
continuous glucose meters, etc. Therefore, the user may be supplied
with relatively immediate feedback through such measures that the
amount of food energy, e.g. glucose, consumed will be anticipated
to result in weight loss or gain, based upon predicted kcal energy
expenditure. These data may also be related to the timing of such
consumption relative to kcal energy expenditure, e.g. exercise,
such that more effective counseling or guidance may be provided to
the user to improve overall metabolic management goals. Other
metabolites in addition to glucose, e.g. circulating fatty acids,
may be utilized in such fashion and therefore the scope of the
present invention is not restricted to the use of glucose in this
regard.
[0081] In a somewhat relate embodiment is the use of patterns or
relationship between relatively short term fluctuations in serum
glucose level as compared to somewhat longer term assessment of
overall serum glucose levels determined through the measurement of
fructosamine on a weekly level to provide a longer term, e.g. 2-3
week, assessment of possible excess serum glucose (energy) levels.
A still longer assessment of overall metabolic management is
provided by determination of glycohemoglobin HbA1c on a monthly or
semiannual basis. These measurements when reviewed provide greater
insight into daily (short term) glucose cycling as well as into the
overall long term management of glucose and or other forms of kcal
intake by the user and therefore may enable improved counseling,
guidance, etc.
[0082] Kilocalorie Energy Expenditure
[0083] In general, in preferred embodiments of the present
invention, determination of kcal energy expenditure over a period
of time is determined by the calculation of basal/resting metabolic
rate and measured activity related kcal energy expenditure over
this period of time. Of these terms, basal/resting metabolic rate
is the primary component of kcal energy expenditure in individuals
having sedentary or low activity lifestyles. Numerous algorithms
derived from population studies are available for the estimation of
this basal/resting metabolic rate and the scope of the present
invention is not restricted to any one form or type of
basal/resting metabolic rate determination.
[0084] In preferred embodiments, sensors enabling calculation of
kcal energy expenditure associated with activity over a period of
time are employed. Numerous devices and approaches may be utilized
to measure activity-based kcal energy expenditure over a period of
time in a more or less continuous fashion. These may include one or
more technologies such as heart rate monitors, ambient
temperature/humidity monitors, accelerometers, temperature
monitors, heat flux monitors, sweat measurement, etc. Such methods
and devices are well known to those skilled in the art of
physiological energy monitoring. In preferred embodiments of the
present invention, one or more such technologies are incorporated
into monitoring platforms, e.g. patches, utilized for the detection
of one or bioparameters useful for the determination of energy
balance.
[0085] Resultant determinations of activity based kcal energy
expenditure over this period of time are then combined with
corresponding energy associated with basal/resting metabolic rate
to arrive at a total determination of kcal energy expenditure over
this period of time. As a further refinement to this and other
embodiments, estimates of basal/resting metabolic rate may be
adjusted to compensate for compositional changes and/or weight
change over extended periods of time, e.g. weeks or months.
[0086] Energy expenditure may vary in individual, e.g. during
sleep, exercising, eating, etc., and therefore one or more sensors
may supply data useful in the quantification of the individual's
kcal energy expenditure for one or more extended, e.g. hours or
days, periods of time, and therefore in preferred embodiments
sensor data is utilized in conjunction with descriptive algorithms
to account for this variation. Typically, corresponding algorithms
utilize additional inputted data, e.g. age, height, gender, with
the data measurements of activity for determination of kcal energy
expenditure. Such tracking of kcal energy expenditure throughout
periods of the day enables identification of periods wherein
activity may be increased or adjusted to better serve the overall
goals of weight management program.
[0087] In preferred embodiment of the present invention,
bioparameter monitors utilized for kcal energy expenditure, e.g.
heart rate monitors, temperature sensors and accelerometers, are
incorporated into the monitoring platform for determination of
energy balance, e.g. sensors having bioelectric impedance and/or
UWR sensing capabilities utilized in the determination of body
composition change.
[0088] In yet other embodiments, kcal energy expenditure may be
determined from inputted data regarding physical characteristics,
e.g. age, approximate weight, height, gender, etc., and data
regarding lifestyles, activity and physical history. Such
embodiments may or may not use one or more devices for the direct
measurement of one or more physiological parameters associated with
kcal energy expenditure. In alternative embodiments, activity kcal
energy expenditures may be estimated either through learned data
from the individual or from population based analyses in order to
arrive at a final determination of kcal energy expenditure of the
user for a period of time.
[0089] In short, the scope of the invention is not constrained to
any one form, device or method for the calculation of kcal energy
expenditure.
[0090] Kilocalorie Energy Intake
[0091] In preferred embodiments of the present invention, kcal
energy intake over a period of time is calculated using Equation 2
using determinations of energy balance and kcal energy expenditure
corresponding to this period of time. In variations of the present
invention, multiple calculations of kcal energy intake may be made
over a period of time (hours, days, weeks, etc.) such that the
overall accuracy of such estimates may be improved and trends
within the data set may be determined.
[0092] In alternative embodiments, estimates of kcal intake
utilizing one or more measured parameters, e.g. serum or
interstitial glucose measurements, are employed in conjunction with
kcal energy expenditure determinations to provide an assessment of
net metabolic balance over a period of time.
[0093] In still other embodiments, the comparator may also
automatically or upon demand review data sets to determine trends
or patterns of kcal energy expenditure, kcal intake and/or energy
balance over a plurality of periods of time. Such analysis may also
include the selection and presentation to the display by the
comparator of one or more recommendations for achieving desired
weight or metabolic status goals. Such recommendations may be
incorporated in the comparator memory as part of look up tables or
lists to be selected from based upon analysis of user data. In
addition, such presentation to the user of one or more suggested
courses of action or activity may be done a certain time points
within a day such that anticipated user behavior may be modified
preemptively, e.g. prompts suggesting alternatives prior to lunch
to avoid excessive kcal intake. In related embodiments, such
patterns may be utilized to create a "signature" for the user such
that a library of such signatures may be compiled and utilized for
comparisons between users or for the user over time. Such trend or
pattern analysis may be accomplished in a variety of fashions, e.g.
time course changes within a certain margin of error, or through
self learning, artificial intelligence or neural net type programs
and analysis. The scope of the present invention is not limited to
any one form or method of data analysis.
[0094] In addition, metabolic information may be compiled over time
to determine trends, patterns or anomalous events. Such information
may be advantageously used for a variety of purposes, including the
estimation of time required for attaining one or more dietary or
metabolic status goals and the anticipatory prediction of energy
intake or expenditure such that guidance, materials, supplies or
other forms of counseling/support, may be given to alter or in
support of a predicted status.
[0095] In yet further embodiments, the results of such analyses may
initiate one or more therapeutic activities in order correct or
assist in weight management or metabolic status objectives. Such
therapeutic activities may include reminders to the user to
administer one or more medications, e.g. metabolic agents such as
leptin, or trigger the automatic delivery of one or more
therapeutic agents. Conversely, such analyses may be useful in the
adjustment of therapy, e.g. the timing and amount of delivered
drugs or agents, based upon the metabolic status of the
individual.
[0096] Such therapeutic activities may encompass operating in
concert with one or more therapeutics devices or treatments for the
management of one or more disease states, e.g. diabetes,
cardiovascular disease, HIV, neuropathy, hypertension, kidney
disease or metabolic syndrome. In one embodiment, forms of the
present invention, implanted or non-implanted, determine in
substantial measure body composition changes, net caloric balance,
kcal energy expenditure and kcal intake over a period of time and
then communicate with one or more therapeutic devices or systems
for the treatment of a disease state. Such forms of the present
invention may be comprised as separate units in direct or indirect
contact with one or more therapeutic devices/systems or may be
integrated within and comprise a portion of the therapeutic
device/system. Examples of such therapeutic devices include, but
are not limited to, devices that may alter behavior or metabolism
through nerve stimulation, e.g. devices that stimulate one or more
nerves to provide the sensation of satiation. Therapeutic devices
may also include devices that measure one or more bioparameters,
e.g. serum glucose, or devices that deliver one or more therapeutic
agents, e.g. insulin delivery systems.
[0097] Multiple forms and methods of triggered responses are
conceivable and the scope of the present invention is not limited
to these examples.
[0098] Display Unit--
[0099] In order to present energy balance, kcal energy expenditure
and kcal intake data as well as additional information, e.g.
suggested dietary/exercise plan changes/recommendations, to the
user, one or more display units may be employed. Display units may
receive this data directly or indirectly from one or more
comparators. Displays may include visual images, textual messages,
sounds and synthetic voices, or mechanical signals, e.g.
vibrations. The means of conveying data and information within the
system of the present invention is not limited to any one means or
form and may change dependent upon the nature of the information
being conveyed.
[0100] In addition, in certain forms of the embodiment, the display
may also enable data input by the user or designated third parties.
In such embodiments, input may be through one or more methods
including: the use of alphanumeric keypad entry, touch pad entry,
menu driven selections or voice activated software. The scope of
the present invention is not limited to any one form or method of
data input.
[0101] An illustration of one form of the system of the present
invention is shown in FIG. 6. As shown, the display 610 contained
with display unit 600 presents to the user data relating both
cumulative and immediately prior period of time, e.g. 24 hour
rolling averages, values for kcal energy expenditure, kcal intake
and energy balance. Such data may be useful to the individual as a
guide to their activities, e.g. exercise and/or dietary behavior,
such that weight management goals may be achieved. Also shown is a
graphical illustration of the net energy balance 620 versus a
predetermined weight goal 615. Also shown within this display is
offset 625 wherein the metabolic parameters, e.g. kcal energy
expenditure and energy intake, are not displayed for a time period
indicated by the gray bar, e.g. minutes, hours or days. Use of such
offset time period in display may serve multiple advantageous
purposes including enabling adequate time for consumed food
digestion and distribution throughout the body to occur prior to
display of calculated data. Also shown are data input buttons 605
for entering useful alphanumeric information into the comparator.
Use of other physiological variables, e.g. analytes (glucose), may
provide an interim calculation of kcal intake while the consumed
food is digested and distributed throughout the body.
[0102] In related embodiments, compositional change such as body
fat percentage and percentage change over time may also be
presented to the user. These data may be presented in textual,
graphical or by other means and may include yet other parameters,
measurements and/or data representative of the user and the history
of use. In still other embodiments, the user may be presented with
data, graphs or other forms of communication conveying predictive
information based upon prior patterned behavior. Such predictive
illustration may include options or alternatives enabling the user
to view various possible scenarios and chose between these as a
course of action to be followed.
[0103] In other embodiments, the display may be multilayered or
multi-component. For example, in one form of the invention, the
display may be a simple symbol or color, e.g. a gold star
indicative of adherence within set limits of desired weight
management objectives or a blue circle indicative of being beyond
desired weight management limits. The user, in this embodiment, may
have the ability to query the data set further, e.g. to see trend
lines and/or recommendations in response to this first level
display. Likewise, such symbols/display features may be
incorporated within a larger display, permitting query, if so
initiated by the user or qualified third party.
[0104] In yet other embodiments, the user may be presented one or
more recommendations to achieve desired weight management goals
from the comparator. Such recommendations may be in the forms of
text messages, alert sounds, mechanical (vibrations) or
combinations of these forms of delivery. These recommendations may
include detailed instructions or recommendations for activity, etc.
or simply serve as alerts or reminders at certain time points
throughout the day. In related embodiments, the user may enter in
one or more reminders or suggested course of action to be display
to them at selected time points, e.g. every noontime. In related
embodiments, one or more display functions may be incorporated into
the structure of a monitoring platform, e.g. if the monitoring
platform is physically distinct from the display unit. In such
embodiments, a visual display, e.g. OLED display, audible display,
mechanical (vibratory) display may be incorporated to provide the
user with incentives, reminders, or other information based upon
performance and/or goals. Supportive actions providing oversight in
diet management while not being directly observed by others is an
advantageous feature of such embodiments of the present
invention.
[0105] In related embodiments, the display may incorporate an
avatar or animated figure to present data, recommendations,
support, etc. to the user to better enable the conveyance of
desired information from the comparator to the user.
[0106] In yet other embodiments, the user may be provided through
text menus, avatar-supplied search results, or by other formats,
information and/or access to one or more outside services, tools,
or weight management aids from which the user might select. Such
services or tools include a number of possible forms, e.g. weight
counseling, exercise plans/programs, diet (meal) supplies, etc. and
the scope of the invention is not limited to the examples presented
herein. In select embodiments, the comparator may initiate
artificial intelligence-based web searchers for applicable
programs, etc. tailored to the individual user's weight management
profile. Such search results may then be presented by the display,
including possibly through the use of one or more avatar
figures.
[0107] In other forms of this embodiment, the user might be
presented one or more of these options or services and upon
selection, be billed by the provider for these services. In
alternative embodiments, the user may have a subscription enabling
use of one or more services automatically. In yet other
embodiments, one or more of these services may be supplied without
cost.
[0108] In a related embodiment, the user may be presented
selections that have been ranked for effectiveness automatically by
the data management system, e.g. the remote comparator. Such
ranking may be done by multiple fashions, e.g. by other users or
automatically by pooling of data derived from multiple users of the
weight management system and the materials in question. Multiple
forms and methods of ranking are conceivable and the method of
ranking is not limited to these examples presented herein. As a
further embodiment, upon selection of one or more services, plans,
etc., the user may have their own data entered and available for
comparison to the results from other users of the selected
materials. In such circumstances, these comparisons may enable the
user to determine if the selected material is effective or if their
own actions are responsible for success or failure.
[0109] In still other forms of the invention, the user data is
transmitted to one or more remote data management systems enabling
review of user data and progress towards weight management or
metabolic status goals. Such information may then be provided to
clinicians, dieticians, or other third parties, including automated
systems, who may assist through counseling or by other actions the
individual user. In certain forms of this embodiment, the data
management system provides alerts or other forms of notification to
outside parties that one or more threshold criteria, e.g. diet rate
or absolute values, has been exceeded and that intervention may be
warranted. In such forms of the present invention, personnel
communication may be enabled through the display unit between a
supportive figure and the user to enable improved dietary,
lifestyle and/or exercise behavior.
[0110] In selected embodiments of the present invention, rewards
for goal attainment or incentives to promote compliance and/or
positive activities on the part of the individual user may be
provided directly by the system or through third parties with at
least some access to the user through the system. Such incentives
may be tangible, e.g. financial, or intangible, e.g. praise, and
the present invention is not constrained to any one form of
incentive and/or reward.
[0111] In certain embodiments, the user's data and/or
acknowledgement of participation in the system of the present
invention may be made known to other users or authorized third
parties. Such data/acknowledgement may be presented in a variety of
formats or methods, e.g. internet based virtual reality sites
utilizing avatars representative of individual system users and/or
other third parties (trainers, coaches or clinicians), text
messaging, or real time internet based video discussion groups. A
benefit from such interactions may be socialization of the user
within a support network which may positively reinforce the user's
involvement with weight or metabolic management programs, plans or
activities. As an extension of such embodiments, the system may
engage with one or more outside sources to enable the automatic
ordering and/or delivery of items useful to the user, e.g. dietary
supplements, prepackaged meals, or motivational media, and may be
based in part upon user data.
[0112] Methods by which one or more embodiments of the present
invention may communicate with remote data management systems
and/or the Internet may be by wired or wireless means. In a
preferred form of the invention, the comparator and display are
contained within a wireless cellular phone thereby enabling remote
communication through wireless network communication
capabilities.
[0113] In addition, the present invention may be used in
conjunction with one or more additional medical systems or devices
to improve the management of care for patients utilizing these
systems or devices or to improve the function of these systems or
devices. Examples of such systems may be those systems providing
satiation control, e.g. through nerve activation or automated
delivery of one or more drugs or therapies, or in the management of
metabolic syndrome involving at least in part the measurement of
serum or interstitial glucose levels.
[0114] Overall, the scope of the present invention is not limited
to the examples presented herein. Additional forms of the invention
are readily conceivable as well as are forms of the invention
involving various combinations of the embodiments presented herein
and therefore are within the scope of the present invention.
EXAMPLES OF USE
[0115] The method and system of the present invention may be
employed for a variety of uses and applications. Such applications
may range from individual users managing body weight to achieve
desired weight goals to clinical/nursing home applications to
ensure adequate nutrition by geriatric patients. Still other
applications of the present invention employ the method and devices
of the present invention to monitor metabolic status and/or derived
components of metabolic status, such as glucose levels.
Example A) Weight Management System
[0116] In this example, the system of the present invention is
comprised of two user enabled devices: an on-body monitoring patch
for the measurement of bioparameters and/or physiological
characteristics enabling determination of body composition change
and kcal energy expenditure and a display unit in wireless
communication with one or more on-body monitoring patches. The
display unit in turn is in communication with at least one remote
data management system through wireless means. In this example, the
display unit (and the preponderance of comparator activities as
well as data input features) of the system are contained within a
cell phone such that the electronic functionalities of the phone,
e.g. logic circuitry, memory and battery power, also enable the
data collection, analysis and display functions of the present
invention.
[0117] To utilize the system according to this example, a user
first activates the system. Activation of the system may, in one
form, be accomplished through the dialing of the cell phone to
connect to a remote data management service for enrollment into the
weight management system. The data management service, in turn, may
download software and/or weight management system service options
to the user's cell phone which is also employed as the
comparator/display device.
[0118] In conjunction with enrollment, the user activates a
monitoring platform for use in the determination of body
composition and kcal energy expenditure. Such activation may
comprise the closing of an electrical contact, installation of a
battery, exposing a photocell switch located on the platform to
light, etc. System activation may also include inputting data to a
comparator located within the cell phone. This input may include
use of the cell phone keypad, or use of verbal/voice recognition
software. This inputted data may include an identifier of the
monitoring platform to enable authentication/decryption of user
data and the synching of the cell phone to the monitoring platform.
Additional inputted data may include useful information for
comparator algorithm use such as age, weight, gender, waist size
and desired weight goal.
[0119] In use, the monitoring platform, in the form of as adhesive
patch, is continually worn on the body, and wirelessly communicates
with the cell phone/display in a periodic fashion, e.g. every few
minutes. When the cell phone is out of range of the patch, the
sensor data is stored in memory on the patch then downloaded to the
cell phone when communication is restored. In this example,
communication between the monitoring platform and the cell phone
may be accomplished through wireless transmission means such as
Bluetooth or Ultra Wideband radio.
[0120] After an initial period, e.g. 1-24 hours, the display may
present the user with their kcal expenditure, energy balance and
kcal intake values. This presentation may be continually updated,
e.g. hourly, such that a rolling 24 hour average is continually
presented to the user. After several days of use, patterned
behavior and trends relative to goals may be determined by the
comparator and displayed to the user. In addition, one or more
suggestions may be relayed to the user to either encourage their
existing activities/diet habits or suggest alterations to reach
weight management goals.
[0121] After a period of use, e.g. one week, the patch may be
removed, and a new patch positioned on the body. Previous data from
the prior patch remains stored within the comparator enabling
calibration of the new patch readings without the need to re-enter
data or loss of the prior data. In one form of this embodiment, the
sensor data from the old patch enables the automatic identification
of the user and may enable full activation of the replacement patch
without the need to re-input other data, e.g. identifiers
associated with the replacement patch, etc.
[0122] Through the cell phone, the comparator may also initiate
internet browsing or menus to enable the user to select from
available options to support their weight management goals through
the remote data management service.
[0123] In a related form of this embodiment, some or all the
sensors, e.g. body composition sensors and activity sensors, are
contained within the cell phone such that the on-body monitoring is
primarily restricted to waking hours when the cell phone is carried
by the user.
Example B) Geriatric Dietary Management System
[0124] In this example, one or more bioparameter monitoring devices
are affixed to, e.g. sensor patches, or otherwise collect data from
monitored individuals and wirelessly communicate with one or more
fixed data collection units, e.g. wall mounted units, located
throughout an assisted care facility. Data from said data
collection units are then compiled at a central receiving station,
e.g. a nursing station, and through the use of one or more
identifiers associated with the bioparameter monitoring devices,
enables the calculation and display of overall energy balance, kcal
expenditure and kcal intake for each specific individual.
[0125] In such embodiments, displays of other bioparameters, e.g.
activity, as well as recommendation, e.g. adjustment of levels of
activity, may be incorporated into displays. In addition, alerts
indicating when clinician or system set limits are achieved or
exceeded may also be included. Extensions of such embodiments may
also include transmission of data and/or transforms of the data to
one or more remote data management systems enabling remote
clinician review and bidirectional communication with either the
individual's monitoring platform and/or the central receiving
station.
Example C) Metabolic Status Monitoring System
[0126] In this form of the present invention, the sensors and
system of the present invention are utilized to provide estimations
of one or more metabolic processes and/or analyte levels. In one
variation of this embodiment, estimations of circulating blood
glucose levels are made. Such estimates may be done through
estimates of kcal energy expenditure and/or nervous activity, e.g.
sympathetic nerve activity, and may utilize data from sensors such
as heart rate, temperature, sweat, nerve monitors, and/or activity.
In addition, estimation of glucose may be further refined by use of
one or more measures of body composition and/or net energy balance.
In such implementations, the comparator/display may be a handheld
unit also having the ability to utilize additional physiological
sensor inputs, e.g. blood strip tests, in addition to the data
received from one or more monitoring platforms. In addition, other
sensors may be utilized to supply information regarding analyte
levels, e.g. circulating leptin or glucose levels, such that a more
complete analysis of body composition, energy metabolism and/or
metabolic status may be made by the comparator.
Example D) Training and Fitness Assessment
[0127] The method and system of the present invention may be used
to assess the overall fitness of individuals as to their metabolic
status and/or body composition. Such assessments may be useful for
individuals engaged in strenuous activities, e.g. military
personnel, first responders, athletes, or individuals to whom
physical appearance and fitness are important criteria for their
occupation, e.g. fashion industry workers, or models. In
particular, in such applications, the system may be triggered by
fat mass loss below a preset level or at an unacceptable rate
indicative of poor or inadequate nutrition or of excessive dieting.
Conversely, the system may be employed to monitor individuals as
they progress through a fitness or training regimen, enabling the
monitoring of body fat loss and the tailoring of caloric (food)
supplements to better fit dietary needs.
[0128] Extension of the present invention to other applications may
include the monitoring of one or more physiological parameters that
may indicate the status of a measured subject's nutritional or
metabolic condition or the detection of one or more physiological
anomalies indicative of injury or trauma. A variety of
applications, based upon the present invention, are readily
conceivable and the scope of the invention is not limited to the
examples presented above.
* * * * *