U.S. patent application number 15/358136 was filed with the patent office on 2018-01-04 for physiological monitor system for determining medication delivery and outcome.
The applicant listed for this patent is PhiloMetron, Inc.. Invention is credited to Naresh Chandra BHAVARAJU, Darrel Dean DRINAN, Carl Frederick EDMAN, Michael Wayne MACCOLLUM.
Application Number | 20180000411 15/358136 |
Document ID | / |
Family ID | 44560754 |
Filed Date | 2018-01-04 |
United States Patent
Application |
20180000411 |
Kind Code |
A1 |
BHAVARAJU; Naresh Chandra ;
et al. |
January 4, 2018 |
PHYSIOLOGICAL MONITOR SYSTEM FOR DETERMINING MEDICATION DELIVERY
AND OUTCOME
Abstract
A method is described for the determination of the taking of a
medication utilizing at least one physiological parameter
monitoring platform. In addition, the method also may enable the
determination of physiological effects or events resultant from the
taking of a medication (or lack thereof) through the use of one or
more physiological monitoring platforms.
Inventors: |
BHAVARAJU; Naresh Chandra;
(San Diego, CA) ; EDMAN; Carl Frederick; (San
Diego, CA) ; MACCOLLUM; Michael Wayne; (Poway,
CA) ; DRINAN; Darrel Dean; (San Diego, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
PhiloMetron, Inc. |
San Diego |
CA |
US |
|
|
Family ID: |
44560754 |
Appl. No.: |
15/358136 |
Filed: |
November 22, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14792400 |
Jul 6, 2015 |
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15358136 |
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13046280 |
Mar 11, 2011 |
9075910 |
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14792400 |
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61340049 |
Mar 11, 2010 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 5/7278 20130101;
A61B 5/00 20130101; A61B 5/7246 20130101; G16H 20/10 20180101; A61B
5/4848 20130101; G16H 40/67 20180101; G06F 19/3456 20130101 |
International
Class: |
A61B 5/00 20060101
A61B005/00; G06F 19/00 20110101 G06F019/00 |
Claims
1. A method for quantifying the effect of a medication on a
patient, the method comprising: providing a monitoring platform
capable of measuring one or more physiological parameters;
obtaining a first set of measurements of the physiological
parameters from the patient by using the monitoring platform to
measure the physiological parameters; compiling a first signature
from a first set of data including the first set of measurements;
and comparing the first signature with a second signature to
determine the probability of a change in the physiological
parameter.
2. The method of claim 1, wherein the second signature is a
baseline signature compiled from a second set of data including a
second set of measurements of the physiological parameters obtained
from the patient during a different period of time.
3. The method of claim 2, wherein a non-physiological event has
occurred between the first period of time and the second period of
time.
4. The method of claim 3, wherein the non-physiological event is a
signal associated with removal of the medication from a
container.
5. The method of claim 3, wherein the non-physiological event is a
signal associated with a delivery of the medication.
6. The method of claim 1, wherein the second signature is a
medication effect signature compiled from a second set of data
including targeted endpoints for the physiological parameters.
7. The method of claim 1, wherein the second signature is a
predefined signature compiled from a second set of data including a
second set of measurements of the physiological parameters obtained
from one or more other patients.
8. The method of claim 1, wherein the second signature is a side
effect signature compiled from predefined tabular data for the
physiological parameters.
9. The method of claim 1, wherein the second signature is a
composite representation of a signature compiled from a second set
of data including a second set of measurements of the physiological
parameters.
10. The method of claim 9, wherein the composite representation is
a multivariate representational line representative of the
signature compiled from a second set of data including a second set
of measurements of the physiological parameters.
11. The method of claim 1, wherein the second signature is a
signature associated with a degradation in health status.
12. The method of claim 1, wherein compiling a first signature
includes weighting each of the physiological parameters.
13. The method of claim 1, wherein the first set of data further
includes one or more of age, gender, and co-morbidities.
14. The method of claim 1, wherein the obtaining a first set of
measurements includes obtaining a first set of measurements for one
or more periods of time having different lengths.
15. The method of claim 1, wherein comparing the first signature
with the second signature includes using a rolling analysis for a
period of time.
16. The method of claim 1, wherein comparing the first signature
with the second signature includes determining a concordance
between the first signature and the second signature.
17. The method of claim 1, wherein comparing the first signature
with the second signature includes using a cluster analysis.
18. The method of claim 1, wherein comparing the first signature
with the second signature includes using a trajectory analysis.
19. The method of claim 1, wherein the medication is a therapy or
an activity.
20. The method of claim 1, wherein the medication is the avoidance
of a behavior or an activity.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 14/792,400, filed Jul. 6, 2015, which is a
continuation of U.S. patent application Ser. No. 13/046,280, filed
Mar. 11, 2011, now U.S. Pat. No. 9,075,910, which claims the
benefit of U.S. provisional application No. 61/340,049, filed Mar.
11, 2010. The applications listed above are hereby incorporated by
reference in their entireties.
FIELD OF THE INVENTION
[0002] The present invention relates to a system enabling the
determination of the taking of a medication utilizing at least one
physiological parameter monitoring platform. In addition, the
system also may enable the determination of physiological effects
or events resultant from the taking of a medication (or lack
thereof) through the use of one or more physiological monitoring
platforms.
BACKGROUND
[0003] Lack of compliance in the taking of recommended medications
including the following of therapeutic treatment regimens may lead
to serious health consequences for patients and increase the
overall cost of care. For example, failure to take a prescribed
medication or taking the medication at incorrect times may result
in a prolongation or possible accentuation of the disease state.
Conversely, over-dosage may result in adverse or non-intended side
effects thereby also possibly negatively impacting the health and
well being of the patient.
[0004] In many instances, the patient or caregiver may not be able
to objectively ascertain whether or not a medication has been taken
in the appropriate fashion or not. In order to provide an
independent assessment of medication delivery and uptake, numerous
solutions have been proposed.
[0005] For instance, Kell (U.S. Pat. No. 5,652,146) teaches the use
of monitoring urine in order to ascertain patient compliance
regarding whether or not a medication has been taken or not as well
as estimating the dosage of the medication within the patient.
However, this form of monitoring still requires compliance on the
part of the patient for obtaining the necessary urine sample and
requires similar metabolic profiles to be shared amongst
individuals in order to enable estimation of drug ingestion and
levels.
[0006] Alternatively, Katzman (U.S. Pat. No. 6,180,414) teaches the
use of breath monitoring for drug metabolites, as compared to
urine, to thereby ascertain whether a drug has been ingested or
not. However, this approach likewise is dependent on the metabolic
profile of the individual which may vary from expected patterns
based on disease state, co-morbidities, genetics, lifestyle,
etc.
[0007] To improve upon the need for metabolic detection and
analysis, Melker, et al. (US Patent Application No. 2005/0054942)
teaches the use of adjuvant to the drug or agent which then may be
detected in the breath as a defined odor. In similar fashion, Kell
(U.S. Pat. No. 5,776,783) teaches the addition of markers which may
be added to drug formulations and then detected in urine to enable
determination of drug ingestion.
[0008] To supersede the need for detection of a metabolite and/or
absorbed/metabolized marker associated with an ingested drug,
others have proposed the use of direct signaling of drug ingestion.
In particular, the use of radio transmitters or radiofrequency tags
(RF tag) has been proposed by numerous individuals. For example,
Covannon, et al. (U.S. Pat. No. 7,616,111) teaches the use of an
ingestible RF tag to monitor the consumption of medicines.
Likewise, Danowski, et al., (U.S. Pat. No. 7,382,263) teaches the
use of a shielded RF tag to monitor the consumption of drugs. In
yet another related form, Zdeblick et al., (US Patent Application
No. 20080284599) teaches the use of a transmitter which becomes
activated upon digestion and exposure to body fluids such as
stomach acids, etc.
[0009] However, none of the above methods for determining
compliance to medicine ingestion considers whether the ingested
materials result in a desired physiological outcome or not. What is
needed is a system that enables not only determination of
compliance to medication use but also gauges the physiological
outcomes associated with compliance such that medication may be
more properly prescribed (e.g. titrated) and the taking of the
medication in a desired fashion verified.
SUMMARY OF THE INVENTION
[0010] The invention described herein presents a novel system for
the determination of the taking of medication based upon
measurement of one or more physiological parameters followed by
analysis and identification of one or more physiological signatures
associated with the taking of medication. In preferred embodiments
of the invention, a plurality of measured physiological data are
employed to compile a physiological signature related to the taking
of one or more medications and/or of signatures associated with the
possible occurrence and severity of side effects associated with
the taking of one or more medications.
[0011] In one form of the present invention, the system enables the
determination (yes/no) of the taking of the medication. To
accomplish this determination, one or more measured physiological
signatures associated either with the taking of the medication,
e.g. swallowing, or signatures associated an outcome arising from
the ingestion of the medication, e.g. relief of one or more
symptoms for which the medication is taken.
[0012] In related embodiments, said physiological determination is
coupled by one or more additional non-physiological measured events
to enable determination of the taking of one or more medications.
In such embodiments, signals associated with the removal or
dispensing of medication from a package or container may be
employed. Alternatively, signals associated with the handling or
delivery of medication may be employed. In still other embodiments,
one or more compounds not having medicinal value but associated
with the medication may be employed to enable measurable signals
and thereby facilitate the determination that medicine has been
taken.
[0013] In other forms of the present invention, an assessment of
the dosage of the taken medicine may be made, based upon one or
more measured physiological parameters. Such assessment may include
determination of whether one or more unwanted side effects may have
occurred or may occur as well as whether one or more desired
symptoms and/or underlying disease conditions has been
relieved.
[0014] In other embodiments of the present invention, a baseline
set of physiological parameters may be created through the
measurement of one or more physiological measurements. Such
baseline data may thereby be employed to facilitate subsequent
determination of physiological change associated with the taking of
medication, tailored to the individual.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] FIG. 1--Illustration of one embodiment of the system of the
present invention.
[0016] FIG. 2--Diagram illustrating the relationship between
measured physiological parameters and symptoms for select disease
states.
[0017] FIG. 3--Illustration of one form of the present invention
employing physiological and non-physiological sensors.
[0018] FIG. 4--Illustration of the relationship between medication
target and side effects as compared to temporal events.
[0019] FIG. 5--Illustration of one embodiment of the present
invention enabling identification of physiological status
associated with a signature.
[0020] FIG. 6--Illustration of one embodiment of a route by which
the comparator receives and processes data.
DETAILED DESCRIPTION OF THE INVENTION
[0021] The invention generally relates to a novel method and system
for the assessment of the taking of one or medications by the
measurement of one or more physiological parameters. A general
outline of a preferred embodiment of the system of the present
invention is presented in FIG. 1. As shown, patient 100 has affixed
to a body region monitoring platform 110 enabling the measurement
of one or more physiological parameters. Communication of measured
data or transforms of the measured data may then be wirelessly
conveyed, as indicated by dash arrow 115, to local data collection
unit 120. Said data may be further analyzed and results displayed
on data collection unit 120. Alternatively, all or some of said
data and/or analysis may then be further conveyed to one or more
remote data management systems, 130, as indicated by staggered dash
line 125. Within remote data management system 130 further review
and analysis of the data may occur as well as additional review by
one or more third parties. Forms of this system having on-body
monitoring platforms comprised of biointerface heads and
control/communication modules, data collection units, and remote
data management systems are described in U.S. Pat. No. 7,044,911
and related filings which are incorporated in their entirety by
this mention herein. A more complete description of each of these
components are presented below.
[0022] Monitoring Platform
[0023] Medications may exhibit different temporal responses between
individuals and/or types of medications due to differing route of
administration, distribution or sequestration within the body,
metabolism and/or excretion. Accordingly, advantageous use may be
made of forms of physiological monitoring wherein one or more
physiological measurements are made, either periodically, upon
demand or in effectively continuous fashion over a period of
time.
[0024] In preferred embodiments of the present invention, one or
more physiological monitoring platforms are affixed to one or more
body regions, e.g. by means of adhesive, such that multiple
measurements may be automatically obtained with minimal patient
compliance. In other embodiments, monitoring platforms may be
invasive or implanted within the body. In yet other embodiments,
such monitoring platforms may reside off of the body, e.g. glucose
tests employing test strips using blood or the testing of collected
body fluid samples.
[0025] In general form, monitoring platforms may incorporate one or
more sensors for the measurement of one or more physiological
parameters. To enable the measurement, storage, analysis and/or
transmission (or display) of such measured data, monitoring
platforms may incorporate necessary electronic circuitry, clocks
and power sources. Such circuitry and power sources are well known
to those skilled in the art of electronics.
[0026] In preferred embodiments, a monitoring platform may employ
materials and structures suitable for its intended use, e.g. if the
monitoring platform utilizes electrode sensors and is affixed to
the body by means of adhesives, the materials in contact with the
body surface would preferably be biocompatible. In similar fashion,
the housing of such monitoring platform if intended to be affixed
to the body for an extended period of time may be water resistant
and in general the platform may be constructed of flexible or
conformable elements to improve patient comfort during use.
[0027] A variety of physiological parameters may be measured by one
or more monitoring platforms. Measured parameters may include, but
are not limited to the following: [0028] Physical--motion,
anthropometrics (e.g. waist, height, weight measurements), tissue
structure and composition [0029] Biochemical--cellular, tissue,
organ or whole body biochemical structure/functions, e.g. cellular
respiration and proliferation, circulating or locally concentrated
small molecules/proteins/peptides, catabolic materials (certain
ketones, lactic acid), blood chemistry (e.g. ion composition, pH,
carbon dioxide, oxygen, blood nitrogen), circulating nutrients
(e.g. glucose, fatty acids, lipids and amino acids) [0030]
Metabolic--vital signs (heart rate, blood pressure, respiration
rate, temperature), basal metabolic rate, hydration status [0031]
Nervous System--central and/or peripheral parasympathetic or
sympathetic activity, cognitive functions, psychological status
(e.g. mood), headaches, sleep patterns [0032] Immune
System--circulating immune cell types and populations, target
responses to specific antigens, immune signaling molecules such as
histamine, cytokines, etc. [0033] Cardiovascular/Pulmonary--heart
functionality (ECG, heart rate variability), respiratory
rate/volume, arterial resistance/stiffening, arterial blockage,
venous return, peripheral circulation, microcapillary
proliferation/circulation [0034] Endocrine/Paracrine--hormones or
endogenous agents (e.g. insulin/glucagon, leptin, steroid hormones,
biogenic amines) [0035] Organs--size, composition and
functionality, (e.g. kidney functionality, liver functionality,
adipose tissue disposition, skin thickness/plasticity) [0036]
Muscular/Skeletal--electromuscular activity (e.g. latent or
stimulated), strength, composition, oxygenation, density [0037]
Gastro-Intestinal--digestive activity and efficiency, gut
microfauna population
[0038] Such measured parameters may be related to one or more
symptoms associated with the taking of medication, e.g. change in
the targeted physiological parameter and/or the occurrence of one
or more side effects. An illustration of the relationship between
physiological parameters and symptoms associated with various
disease states is presented in FIG. 2. As shown, one or more
measured parameters may be utilized to identify one or more
symptoms associated with a change in physiological status
associated with the taking (or lack thereof) of one or more
medications. Also illustrated in this example is that different
disease conditions may utilize different medications and different
measured parameters.
[0039] To measure one or more of the above parameters, one or more
sensors may be employed. Such sensors may involve the exchange of
one or more energies with one or more body regions. Such energies
may include, but are not limited to, mechanical energies, photonic
energies, electrical energies, radioactive energies, magnetic
energies, acoustic energies, electromagnetic energies, and chemical
energies.
[0040] For example, blood oxygen and heart rate may be measured by
use of photonic energies, e.g. pulse oximetry, in order to provide
necessary data. Likewise, body hydration or change in hydration may
be assessed through use of one or more bioelectrical impedance
measurements. Still other measurements, e.g. tissue structure, may
be determined by use of electromagnetic energies such as ultra
wideband radar, or acoustic energies such as ultrasound
energies.
[0041] Within the scope of the present invention, sensors may be
employed that do not involve the direct exchange of one or more
energies with one or more body regions. Such sensors may passively
receive energies from a body region, e.g. temperature sensors,
accelerometers for motion, ECG/EMG/EEG sensors detecting
endogenously produced electrical signals, etc.
[0042] In addition, sensors may measure one or more samples
obtained from a body region, including body fluids, e.g. analysis
of blood, sweat, urine, saliva, tears. Likewise one or more exhaled
or transpired gases may be analyzed, e.g. breath composition for
ketones, etc. Likewise, fecal materials may be analyzed, e.g. for
blood, microfauna, etc. Such sensors may include the use of one or
more devices or technologies associated with in vitro diagnostic
(IVD) devices and/or of more complicated systems, e.g. mass
spectrometers.
[0043] In still other forms of the invention, a tracer or
introduced agent or material may be employed to facilitate the
assessment of one or more parameters. Examples of such agents may
include the use of radiolabeled tracers, e.g. deuterium labeled
water, to facilitate assessment of total body water and change in
total body water. Likewise, agents may be supplied that
preferentially are sequestered into a body region or compartment,
e.g. tumor specific markers, and thereby would facilitate analysis
of these tissues or organs through use of one or more measurement
technologies selected to measure one or more properties inherent in
these markers. In this form of the invention, the tracer, agent or
material may be controlled and/or interrogated by a monitoring
platform to facilitate analysis of one or more physiological
parameters.
[0044] In still other embodiments, one or more physiological status
parameters may be obtained through use of subjective assessment
provided by the measured subject. For example, the subject may
reply to an automated voice query received by telephone wherein the
reply would automatically be quantified, e.g. a yes equal to a
numeric value of 1 and a no being a numeric value of zero. These
data may include a number of physiological parameter assessments
made by the individual, including a general assessment of health
status, mood, and/or specific physiological conditions, e.g.
difficulty breathing. In addition, such queries may also involve
self reporting regarding the taking of one or more medications.
Data from such systems may be automatically collected and
transmitted to one or more comparators of the present
invention.
[0045] As yet a further refinement, various embodiments may employ
analysis of voice patterns, speed of response, tones of voice or
other parameters independent of the spoken content of the
communication. For example, detection of a change in pitch or tone
of an individual's response may be associated with physical illness
onset and/or depression. Parameters arising from such assessments
may be included within the data provided to one or more comparators
for facilitating analysis of whether or not a medication has been
taken or not.
[0046] In general terms, the anticipated physiology associated with
a disease or condition and the associated response to medication
and possible side effects may be employed in the selection of
sensors to be utilized in the monitoring platform for a particular
patient. In many instances, it is anticipated that a core set of
physiological parameters will be employed as a general gauge of
patient health status.
[0047] In addition, use of one or more sensors not associated with
the direct monitoring of a physiological parameter may be employed
to facilitate analysis of the patient's taking of medication and
the response to this medication. For example, as shown in FIG. 3,
patient 300 has monitoring platform 330 for measuring physiological
parameters and then transmitting said data (315) to data collection
unit 320. Also shown is an enlarged representation of a medication
container 350 wherein individual unopened 345 and opened 355
medications are contained. The action of opening an individual
medication to enable taking the medication triggers a signal to be
sent from circuitry unit 340 located on the medication container
350 to data collection unit 320. Such signals may be coordinated
with physiological measurements to enable assessment of the taking
of mediation and/or serve as time points to better enable the
subsequent analysis of physiological measurements to one or more
changes in physiology associated with the taking of medication.
[0048] Data Collection Unit
[0049] In a preferred embodiment, the data collection unit serves
to collect the information from one or more monitoring platforms to
enable the assessment of patient compliance to the taking of one or
medications and the resultant response of the patient's physiology
to such activity. In general terms, the data collection unit has
one or more means for receiving information, including patient
specific identifiers, e.g. identifiers of the monitoring platform
or components therein, as well as data and information generated by
one or more monitoring platforms. In preferred embodiments,
measured patient data is received wirelessly however other forms of
data entry, e.g. through keyboards, by voice recognition software,
direct wired connection, etc. are conceivable and are included
within the scope of the present invention.
[0050] In various embodiments, the data collection unit may also
have one or more display functionalities, e.g. visual or audible,
to enable conveyance of monitoring platform operation and/or
patient status to the patient or other individual. In addition, the
data display unit may store data from one or more patients to
facilitate subsequent analysis and/or transfer to one or more
remote monitoring systems. Such data collection units may take the
form of handheld units, e.g. cell phones, or personal digital
assistants, with the appropriate transmission capabilities and
software to enable the present invention.
[0051] One or more comparators may be present as part of the data
collection unit functionalities. Such comparators may be utilized
to facilitate analysis of received data to enable the determination
of medication usage as well as the associated physiological
response to the medication. Comparator functionality may also
reside in whole or in part in other system components, e.g. within
monitoring platforms and/or remote data management systems.
[0052] A primary function of the comparator is to determine if a
medication has been taken or not. In order to make this assessment,
in preferred embodiments, the comparator may utilize one or more
sets of data reflective of baseline status, i.e. prior to taking
the medication, and compare these data to one or more sets of data
to determine physiological events associated with the taken of
medication.
[0053] In forms of medication which involve oral ingestion,
measured physiological data may include the measurement of physical
activities associated with the act of swallowing, e.g. throat
muscle constrictions and/or audible signals arising from the gut.
To facilitate the identification of a physiological event with
medication ingestion, one or more non-physiological sensors may be
employed. For example, a sensor associated with a container or
packaging that wirelessly transmits a signal to a data collection
unit indicating the opening of the container, when combined with
the measurement within a predetermined period of time, e.g.
minutes, may serve to support the likelihood that a medication has
been consumed in a desired fashion.
[0054] In yet other forms of the invention, one or more signaling
agents or transmitters may be associated with the medication itself
such that the ingestion of the medication results in a signal that
is receivable by one or more monitoring platforms. Physiological
monitoring in combination with such signals would increase the
likelihood of correctly assessing that a medication has been taken
in a desired fashion.
[0055] Other forms involving taking of medication, e.g. injection,
may include one or more sensors placed on the medication delivery
device or system that would signal that the medication is present
and/or the delivery device has been activated in a desired
fashion.
[0056] In still other forms of the invention where the medication
does not take the form of a drug or agent but is rather a therapy
or activity, e.g. physical therapy as part of rehabilitation,
exercise, or smoking cessation, monitoring platform measurements
may include the measurement of one or more physiological parameters
associated the therapy. For example, in a rehabilitation activity
involving the motion of a limb, a monitoring platform may measure
the frequency, rate, and extent of movements of the limb as well as
the time of these movements. A similar form of monitoring may be
employed for the assessment of exercise being conducted according
to an intended form.
[0057] Conversely, applications wherein the desired medication is
the avoidance of a behavior or activity, the monitoring platform
may employ sensors enabling detection of the undesired behavior,
e.g. smoking. By the absence of measured data that would be in
concordance with the undesired activity, the comparator may then
assess that the undesired activity has not occurred.
[0058] A second aspect of the comparator activities may be the
assessing of physiological events resultant in the taking of
medication to aid in ascertaining whether inadequate, sufficient or
excess amounts of medication have been taken. In broad terms, a
medication may have an immediate (or rapid) effect resultant in a
desired change in one or more physiological parameters, e.g.
improved airway function or cessation of heart arrhythmias.
Alternatively, the desired change may take an extended period to
occur, e.g. days or weeks such as in the case of many antibiotics
or anti-inflammatory drugs. Such temporal issues may or may not be
directly associated with the dosage and frequency of the
medication.
[0059] In similar fashion, side effects of the medication, whether
benign or adverse, may occur immediately, or occur after an
extended period of time has elapsed. Accordingly, multiple possible
scenarios between targeted actions of medications and possible side
effects are conceivable. An illustration of this complex
relationship between targeted effects and side effects is presented
in FIG. 4. In addition, targeted actions and side effects may also
depend on the medication dosage and frequency of
administration.
[0060] To overcome this complexity, in preferred embodiments of the
present invention, one or more sets of physiological measurements
and/or values derived from these measurements are compiled into
data sets termed signatures. By comparison of signatures
representative of physiological status in various states, e.g.
prior to medication, during the taking of medication and following
medication, facilitates comparator assessment as to whether the
medication has been taken and whether a desired or non-desired
physiological outcome has occurred.
[0061] Accordingly, multiple forms of signature may be utilized by
the comparator. Forms of these signatures include:
[0062] Baseline Signature--
[0063] Prior to the taking of one or more medications, a baseline
series of measurements may be acquired. Factors involved in such
measurements may include selected vital signs, e.g. heart rate,
respiration rate, blood pressure. In addition, parameters that may
be measured and used by the comparator to determine the taking of
the medication, its effect and possible side effects may also be
measured during this period.
[0064] Medication Administration Signature--
[0065] During a controlled, i.e. defined period during which one or
more medications is observed to be taken, one or more physiological
measurements may be acquired. These measurements, e.g. of
swallowing, heart rate change, etc., may then be utilized by the
comparator to facilitate subsequent identification of the taking of
medication. In addition, one or more non-physiological
measurements, e.g. container opening signals, may be taken and
included within the medication administration signature to provide
a more complete profile by which to identify subsequent taking of
medication.
[0066] Medication Effect Signature--
[0067] Medication is generally targeted to a specific biological
endpoint. Accordingly, following the taking of a medication, one or
more physiological responses associated with the targeted endpoint
may be measured and recorded for subsequent comparative use.
Alternatively, targeted endpoints and the associated physiological
measurements may be forthcoming from measurements derived from
other patients or use scenarios such that the Medication Effect
Signature may be available for use by the comparator as a
predefined set of parameters and values.
[0068] Side Effect Signature--
[0069] Side effects to the taking of medications may be benign,
i.e. without serious health consequences, or may lead to
inadvertent adverse health events. As many adverse events may stem
from one or more physiological parameters exceeding desired or
normative values, use of predefined tabular data may be employed
for the construction of side effect signatures tailored to the
particular disease state, medication and/or patient population.
These signatures in turn may be employed by the comparator to
identify and quantify the occurrence and/or progression of one or
more side effects.
[0070] In a preferred form of the present invention, the comparator
may perform a rolling analysis to which data sets representative of
time periods are continually evaluated to identify the presence of
one or more signatures indicative of one or more of the above
possible signature states. This analysis may be performed in a
variety of fashions and the present invention is not constrained by
any one form or type of mathematical process. For example, a data
set may be compared for the degree of similarity to each parameter
comprising a signature, e.g. a comparison of temperatures over a
period of time.
[0071] Alternatively, a comparison may be made between a composite
representation, e.g. a multivariate representational line
representative of the signature, and the measured data. The degree
of closeness or concordance may then be employed to estimate the
likelihood that a portion of the data set is representative of a
signature event. Such concordance may be determined using one or
more mathematical approaches well known to those skilled in the art
of statistics. As an extension of this form of comparative
evaluation, transforms of data sets, e.g. compressing time scales,
etc., may be employed to facilitate matching of one or more data
sets to signatures.
[0072] An illustration of the determination of concordance is
presented in FIG. 5. Panel A presents a composite representation of
a signature, e.g. a medication effect signature. Panel B presents
monitoring platform data obtained over an extended period of time
to which the signature is matched. The region exhibiting the
highest degree of concordance, e.g. the lowest amount of residual
error between signature and observed values, may then be determined
to be resultant from the medication. Acceptance of whether the
degree of concordance arises to a sufficient level of probability
may be performed mathematically using statistical approaches or
through qualitative inspection of the data set.
[0073] As a further extension, weighting of one or more parameters
utilized to describe a signature and/or measured data may be
employed to provide greater insight into the likelihood that a
signature event has occurred or not.
[0074] Alternatively, more simple approaches may be used to
determine the extent and likelihood of change from one or more
baseline values. Such approaches may use statistical approaches to
identify a signature event or change in health status indicative of
the taking or not taking medication and/or the result of such
taking of medication.
[0075] In other forms of the invention, other forms of analyses of
physiological and/or other data are employed to identify those
measurements associated with the taking of medication and/or
physiological consequences from the taking of medication. Such
forms of analysis may include the comparative assessment of change
in one or more physiological parameters beyond a preset limit and
thereby signaling an event such as an undesired side effect. Such
events may be scored or scaled to represent the extent of deviation
from a baseline value and thereby enable further analysis of
patterns or trends within the data set. Such further analysis may
include the ranking of the data from parameters, e.g. with certain
parameters having more decision weight than others, to facilitate
the determination of the likelihood of a medication event or
outcome occurring.
[0076] In yet other forms of analysis, data from one or more
parameters taken at a point in time are represented as a single or
multidimensional point. Compilations of such points over time
enables cluster analysis wherein drift of data away from clusters
representative of baseline conditions may be associated with the
taking of medication, relief of symptoms targeted by the medication
or the occurrence of one or more side effects.
[0077] In a somewhat related form of analysis, trajectory analysis
of one or more measured parameters may be employed to facilitate
identification of deviations from projected values. Such deviations
in turn may be subsequently identified as being associated with one
or more events, e.g. the taking of medication, the occurrence of a
side effect, etc.
[0078] To facilitate the identification of events, one or more
approaches may be taken to progressively shift one or more baseline
parameters to better accommodate change occurring in the patient's
physiological status. Such changes may include change in parameters
associated with improvement or degradation of health status. In yet
other forms of the invention, such changes may include the
removal/replacement of one or more monitoring platforms.
[0079] In many forms of analysis, comparison between short term
events and long term events and their trends may be made to
facilitate the identification of taking of medication and possible
physiological changes associated with the taking of medication,
e.g. the relief of symptoms and/or the occurrence of side effects.
Periods of times describing the length of short term and long term
time periods may be predefined to reflect the nature of the disease
state, the type of medication employed and the response to the
applied medication and anticipated side effects. Alternatively,
such discriminations may be made by retrospectively comparing
collected data over time to identify these periods as associated
with the taking (or not) of medication.
[0080] In short, a variety of methods and approaches are available
to enable identification of the taking of medication, and the
physiological consequences of the taking of medication and the
scope of the present invention is not constrained to any one
approach or method.
[0081] Data and the results of data analysis by the comparator may
be displayed in part or in whole on the data collection unit.
Alternatively, the data and analysis may be displayed on the remote
data management system to enable additional review and further
analysis. Such displays may also include alerts, reminders of
medication or notifications such that patient status may be noted
and responded to in a timely fashion. These alerts, notifications
or other responses to data may also be present on the data
collection unit.
[0082] In yet other embodiments, the remote data management system
serves to collect and enable the review of data sets and analyses
from a plurality of individuals being monitored. Such collective
review and analysis may facilitate the identification of types of
physiological states, e.g. adverse events, associated with select
patient populations and/or types/dosages of medications.
[0083] An outline of a preferred route by which the comparator
receives and processes said data is presented in FIG. 6. As shown,
the first stage is the data input, e.g. the receiving of
information by the comparator generated by one or more sensors
and/or inputted to the comparator by an individual. Sensor data may
include one or more data received from an on-body monitoring
platform. Inputted data may include information useful to the
comparator such as identifier associated with the individual and/or
additional data regarding the individual's status or condition,
e.g. age, gender, co-morbidities. Received data may be held in one
or more memory storage or buffers for subsequent stages.
[0084] The next stage of the preferred route is the data
verification and organization stage. The first portion of this
stage is the verification of received data as being appropriate for
the data set assembled. For example, data may be erroneously
received by the system from sensors not measuring the individual in
question. Alternatively, the system may be monitoring a number of
individuals and require sorting of data sets according to each
individual to enable subsequent analysis. A second component of
such verification is to ensure the integrity or completeness of the
received data such that incomplete or garbled data is not
incorporated into a data base thereby confound subsequent analysis.
In receiving sensor data, such data is preferably structured to
permit subsequent verification and organization within the
comparator.
[0085] One such structure facilitating such verification and
organization is that of organized fields or segments within the
transmitted data block. For example, a first segment may include an
identifier specific to the monitoring sensor such that data having
such identifiers may be linked to the appropriate individual's data
set within the comparator, i.e. through use of one or more look-up
tables of previously entered sensor identifiers cross referenced to
the individual. A second segment may include information related to
the time of data collection or monitoring of the individual, e.g. a
time/date stamp, such that received data may be hierarchically
assembled in temporal fashion within the comparator's database. A
third segment may include the data itself or a representation of
the data, e.g. amount of change from previous measured data. A
fourth segment may represent a check sum value or other method by
which the comparator may verifying completeness of the data as
transmitted and received. In related embodiments, one or more
identifiers may be utilized to assist in the encryption of the data
contained within the transmitted data. Such identifiers may serve
as encryption keys utilizable by the comparator to de-crypt the
received data.
[0086] Upon determination that the received data is appropriate and
complete, the third stage of the process is the generation of one
or more signatures for assessing whether a medication has been
taken or not. As described previously, such signatures may employ
data from one or more sensors. Signatures may be composed by
assembling a set of sensor data over a period of time previously
defined as representative or useful, e.g. heart rate over a 24 hour
period encompassing activity and sleep. Once assembled, such data
may then be fitted to a curve or mathematical function, e.g. a
higher order function having multiple troughs and peaks, to permit
comparative analysis to one or more other data sets representative
of a similar period of time to establish the degree of difference
between the two data sets. Alternative, comparisons may be made on
direct comparison between data taken at similar time points or
intervals, e.g. heart rate or hydration status at a specific time
of day.
[0087] Yet another form of signature may employ data from two or
more sensors wherein the time component within the period utilized
for the signature is normalized in some fashion to enable
combination of the two data sets into a single form. For example,
hydration change, having a slow basis of change throughout the day,
may be normalized relative to percent change from a lowest point
within that day, thereby providing a single value representative of
the overall range of change. Heart rate, a more rapidly changing
parameter, may likewise be normalized to maximal change observed
within the day to provide a similar metric representative of the
range of change. Once created such normalized data may then be
averaged or otherwise mathematically manipulated to provide a
single signature value representative of both parameters over this
period of time to which other signature values may be compared. It
will readily be appreciated that multiple forms of such
mathematically manipulations combining two or more types of sensor
data are conceivable and that the scope of the present invention is
not limited to those examples presented herein.
[0088] Once created, a simple form of comparison between signatures
may involve the determination of absolute differences in values
between the signatures which then may be utilized to determine the
average percentage change over the period of time. More elaborate
forms of mathematical analysis comparing two or more signatures are
conceivable and the scope of the invention is not limited to this
one simple example.
[0089] Upon determination of differences between two or more
signatures, the response or fourth stage of this process occurs. In
simple instances, this response may be the recording of the
difference into a second data table providing a temporal record of
one or more individual's physiological changes relative to one or
more signatures over time. Such records may facilitate subsequent
analysis of obtained data regarding compliance and/or drug
efficacy. A second form of response may be to provide an alert
either to the monitored individual or to another party if one or
more preset limits are exceeded. For example, if a heart rate
signature passes beyond a preset limit, then an alert, e.g. an
email or flashing display, may be sent or displayed to one or more
individuals to enable possible intervention.
[0090] Alternative forms of processing data according the present
invention and the scope of the invention is not limited to that
example presented herein.
Examples of Use
[0091] Selected examples of applications and uses are presented
below.
[0092] Geriatric Medication--
[0093] Seniors or other individuals may have difficulty complying
in taking one or more medications. Accordingly one form of the
present invention may include the use of a monitoring platform
affixed to the individual plus a data collection unit configured to
be readily employed by the elderly, e.g. large type font, clear
instructions.
[0094] Upon programming of the data collection unit, e.g. by a
clinician or care giver, the system will monitor the basic health
parameters, e.g. nutritional status, activity, selected vital
signs, etc. plus possible hallmarks specific to the prescribed
medication, e.g. heart rhythm and pacing. Review of analyzed data
will then aid in ensuring the proper taking of medication.
[0095] Drug Study Compliance--
[0096] Evaluation of the efficacy of new medications is facilitated
by the knowledge that the study volunteers are adhering to the
recommended medication regimen, e.g. taking the test medicines at
the appropriate times. The present invention would facilitate this
evaluation by improving the knowledge that test medications are
being taken (or not) by the study volunteers. In addition, the
monitoring of multiple physiological parameters may enable early
detection of one or more unforeseen side effects associated with
the medication. Such early detection may enable either adjustment
of the study and/or cessation of the study, thereby improving study
participant safety.
[0097] Corporate Wellness Program Participation--
[0098] Participation by individuals in corporate wellness programs
may be improved by the use of monitoring systems such as the
present invention. In particular, programs promoting increased
exercise and/or smoking cessation may be improved by increased
compliance by participants. In particular, the knowledge of
participants that the system is monitoring their activity and
general health status may provide extra incentive to adhere to
recommended medication (therapy guidance). In addition, the ability
of the monitoring platform, if continually affixed to the
participant, enables the creation of set of physiological data
specific to the individual. Such individual data sets may serve as
an identifier such that the participant is less likely to try to
have another individual wear the monitoring platform and thereby
deceive or trick the system, i.e. the identifier would enable
comparator detection and subsequent alert.
[0099] Chronic Illness Monitoring--
[0100] For individuals suffering from a chronic illness, e.g.
congestive heart failure, Parkinson's disease, etc., knowledge by
clinicians of patient compliance to prescribed medications and the
effectiveness of these medications is useful. Accordingly, the
present invention may be employed to monitor these individuals over
extended periods of time to better enable assessment of medication
effectiveness and/or enable intervention to improve patient health
status.
[0101] 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.
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