Case 3:20-cv-02246-DMR Document 1-3 Filed 04/02/20 Page 1 of 22
`Case 3:20-cv-02246—DMR Document 1-3 Filed 04/02/20 Page 1 of 22
`
`EXHIBIT C
`
`EXHIBIT C
`
`

`

`(12) United States Patent
`Frix et al.
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 9,717.464 B2
`*Aug. 1, 2017
`
`USO0971 7464B2
`
`(54)
`
`(71)
`
`(72)
`
`(*)
`
`(21)
`(22)
`(65)
`
`(63)
`
`CONTINUOUSTRANSIDERMAL
`MONITORING SYSTEMAND METHOD
`
`Inventors:
`
`Applicants:
`James Tyler Frix, Calhoun, GA (US);
`Andrew Johnson, Athens, GA (US);
`James Mitchell Frix, Calhoun, GA
`(US); Robert Andrew Taylor,
`Anderson, SC (US)
`James Tyler Frix, Calhoun, GA (US);
`Andrew Johnson, Athens, GA (US);
`James Mitchell Frix, Calhoun, GA
`(US); Robert Andrew Taylor,
`Anderson, SC (US)
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`This patent is Subject to a terminal dis
`claimer.
`
`Notice:
`
`Appl. No.:
`15/131,130
`
`Filed:
`
`Apr. 18, 2016
`
`Prior Publication Data
`Aug. 11, 2016
`US 2016/0228.065 A1
`
`Related U.S. Application Data
`Continuation of application No. 14/795,157, filed on
`Jul. 9, 2015, now Pat. No. 9,339,237, which is a
`(Continued)
`
`(51)
`
`Int. C.
`A6 IB 5/02
`A6 IB5/00
`
`(2006.01)
`(2006.01)
`(Continued)
`
`(52)
`
`U.S. C.
`... A61 B 5/721 (2013.01); A61 B 5/0004
`CPC .........
`(2013.01); A61 B 5/02416 (2013.01);
`(Continued)
`
`(58) Field of Classification Search
`CPC ..... A63B 2220/40: A61 B 5/1118; A61 B 5/02:
`A61B 5/024; A61 B 5700; A61B 5/1455;
`(Continued)
`References Cited
`
`(56)
`
`U.S. PATENT DOCUMENTS
`
`6,697,655 B2 *
`
`7,658,716 B2
`
`2/2004 Sueppel ............. A61B 5.14551
`600/310
`
`2/2010 Banet et al.
`(Continued)
`
`FOREIGN PATENT DOCUMENTS
`
`102006O1797O A1 10, 2007
`DE
`2006O79862 A2
`8, 2006
`WO
`Primary Examiner — Navin Natnithithadha
`Assistant Examiner — Eric Messersmith
`(74) Attorney, Agent, or Firm — Smith Tempel Blaha
`LLC; Matthew T. Hoots
`(57)
`ABSTRACT
`Various embodiments of methods and systems for continu
`ous transdermal monitoring (“CTM) are disclosed. One
`exemplary method for CTM begins by monitoring an output
`signal from an accelerometer. The accelerometer output
`signal may indicate acceleration and deceleration of a body
`part of a user, such as the user's wrist. Based on the
`accelerometer output signal, it may be determined that the
`body part of the user has decelerated to a minimum, e.g.,
`substantially Zero. With a determination that the body part
`has decelerated to the minimum, e.g., Substantially Zero, or
`has not accelerated beyond the minimum, e.g., Substantially
`Zero, the method may determine a reading from a pulse
`Oximeter associated with the accelerometer. Advanta
`geously, the pulse oximetry reading, or a reading from other
`sensors associated with the accelerometer, may be optimally
`accurate as motion artifact may be minimized. The pulse
`Oximetry reading may be recorded for later query and/or
`rendered for the benefit of the user.
`
`20 Claims, 8 Drawing Sheets
`
`
`
`Case 3:20-cv-02246-DMR Document 1-3 Filed 04/02/20 Page 2 of 22
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`

`

`US 9,717.464 B2
`Page 2
`
`5/6824: A61B5/0004: A61 B 5/02433;
`A61 B 5/14552; A61 B 5/74; A61 B 5/742:
`A61 B 5/721: A61 B 5/1126; A61B
`2560/0475; A61 B 5/0024; A61 B 5/01;
`
`See application file for complete search history.
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`8,172,722
`8,253,586
`8,289,185
`8,396,687
`8,477.046
`2005/0228298
`
`5, 2012
`B2
`8, 2012
`B1
`B2 10, 2012
`B2
`3, 2013
`B2
`T/2013
`A1* 10, 2005
`
`2007/OO32711
`
`A1* 2/2007
`
`2008. O146895
`2009/0227852
`2010, O298683
`2011 0166491
`2011 O213226
`2012/0172679
`2012/0179067
`
`6, 2008
`A1
`9, 2009
`A1
`A1 11/2010
`A1
`T/2011
`A1
`9, 2011
`A1
`T/2012
`A1* 7, 2012
`
`2012fO221254
`8, 2012
`A1
`2013/O125295
`5, 2013
`A1
`A1 12/2013
`2013,0321168
`2014/OOOOO11
`A1
`1, 2014
`* cited by examiner
`
`Molyneux et al.
`Matak
`Alonso
`Vock et al.
`Alonso
`Banet ................... A61B5/0205
`600,485
`Coakley ............. A61B 5.14552
`600,323
`
`Olson et al.
`Glaser
`Cabrera et al.
`Sankai
`Miller et al.
`Logan et al.
`Wekell ................. A61B 5,4848
`600,587
`
`Kateraas et al.
`Krueger
`Mahony et al.
`Johnson
`
`Related U.S. Application Data
`continuation of application No. 14/324963, filed on
`Jul. 7, 2014, now Pat. No. 9,107,644.
`(60) Provisional application No. 61/979,570, filed on Apr.
`15, 2014, provisional application No. 61/843,111,
`filed on Jul. 5, 2013.
`
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`
`(51) Int. Cl.
`A6 IB 5/024
`A6B 5/45.5
`A61 B 5/II
`A61 B 5/01
`A61 B 5/0205
`A61 B 5/021
`A61 B 5/O53
`(52) U.S. Cl.
`CPC ...... A61 B 5/02433 (2013.01); A61 B 5/14551
`(2013.01); A61 B 5/14552 (2013.01); A61B
`5/6824 (2013.01); A61 B 5/74 (2013.01); A61B
`5/742 (2013.01); A61 B 5/0024 (2013.01);
`A61 B 5/01 (2013.01); A61 B 5/021 (2013.01);
`A61 B 5/0205 (2013.01); A61 B 5/0537
`(2013.01); A61 B 5/I 112 (2013.01); A61B
`5/1118 (2013.01); A61 B 5/I 126 (2013.01);
`A61 B 5/4809 (2013.01); A61B 2560/0242
`(2013.01); A61 B 2560/0475 (2013.01); A61B
`2562/0219 (2013.01)
`(58) Field of Classification Search
`CPC ............ A61 B 5/02416: A61 B 5/14551: A61B
`
`Case 3:20-cv-02246-DMR Document 1-3 Filed 04/02/20 Page 3 of 22
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`Case 3:20-cv-02246-DMR Document 1-3 Filed 04/02/20 Page 4 of 22
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`US 9,717.464 B2
`
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`

`U.S. Patent
`
`Aug. 1, 2017
`
`Sheet 2 of 8
`
`US 9,717.464 B2
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`
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`Case 3:20-cv-02246-DMR Document 1-3 Filed 04/02/20 Page 5 of 22
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`

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`Case 3:20-cv-02246-DMR Document 1-3 Filed 04/02/20 Page 6 of 22
`Case 3:20-cv-02246-DMR Document 1-3 Filed 04/02/20 Page 6 of 22
`
`U.S. Patent
`
`Aug. 1, 2017
`
`Sheet 3 of 8
`
`US 9,717,464 B2
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`\_
`\_
`
`K\\
`
`FIG.23
`
`Time P244
`
`v
`D-
`
`m
`a.
`
`P1
`
`001mm 10 uonongp Euneogpu!
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`
`

`

`U.S. Patent
`
`Aug. 1, 2017
`
`Sheet 4 of 8
`
`US 9,717.464 B2
`
`START
`METHODFOR N
`PULSEOXIMETRY X
`DETERMINATIONUSINGTIME,
`STAMPCOMPARISON/
`
`3OO
`/V
`
`305 Receive Pulse Oximetry
`&
`Readings and
`ASSOCiated Time
`Stamps
`
`310 Receive ACCelerometer
`&
`Readings and
`ASSOCiated Time
`Stamps
`
`Determine
`
`Readings and
`ASSOCiated Time
`Stamps
`
`Identify Pulse Oximetry
`Readings with
`ASSOCiated Time
`Stamps Correlated to
`Time Stamps
`ASSOCiated with
`Accelerometer Trigger
`Readings
`
`Output identified Pulse
`Oximetry Readings
`
`Case 3:20-cv-02246-DMR Document 1-3 Filed 04/02/20 Page 7 of 22
`
`
`
`FIG. 3
`
`

`

`U.S. Patent
`
`Aug. 1, 2017
`
`Sheet S of 8
`
`US 9,717.464 B2
`
`//
`
`
`
`START
`METHODFOR N
`REAL TIMEPULSEOXIMETRY Y,
`DETERMINATIONUSING /
`ACCELEROMETER /
`
`
`
`
`
`
`
`
`
`
`
`ACCeleration
`Minimized?
`
`NO
`
`Reading and Output to
`User
`
`Case 3:20-cv-02246-DMR Document 1-3 Filed 04/02/20 Page 8 of 22
`
`FIG. 4
`
`

`

`U.S. Patent
`
`Aug. 1, 2017
`
`Sheet 6 of 8
`
`US 9,717.464 B2
`
`START
`METHODFOR N
`FITNESSFACTOR
`DETERMINATION
`
`505 Determine start time for
`is physical exertion by
`USG
`
`
`
`physiological and non
`physiological
`parameters
`
`520
`N
`
`
`
`
`
`arameter exceed
`threshold?
`
`Continue to monitor
`COmbination of
`physiological and non
`physiological
`parameters
`
`Case 3:20-cv-02246-DMR Document 1-3 Filed 04/02/20 Page 9 of 22
`
`500
`
`
`
`
`
`Calculate RealTime
`Fitness Factor and
`Output to User
`
`Determine end time for
`physical exertion by
`USe
`
`Store monitored data
`and average Fitness
`Factor
`
`FIG. 5
`
`

`

`U.S. Patent
`
`Aug. 1, 2017
`
`Sheet 7 of 8
`
`US 9,717.464 B2
`
`PMC
`18O
`
`
`
`
`
`Power Supply
`188
`
`Video
`Port
`138
`
`Stereo
`Speaker
`154
`
`
`
`1OO / 125
`
`Display /
`TouchSCreen
`132
`
`CCD / CMOS
`Camera 148
`
`USB
`POrt
`142
`
`Display
`Controller
`128
`
`Touch
`SC66
`Controller
`130
`
`CPU 11 O
`Oth Core 222
`
`1st Core 224
`th
`Nth Core 230
`
`
`
`Controller
`140
`
`GPU 135
`
`SM Card
`
`Stereo
`Speaker
`
`Audio
`Amplifier
`
`"TE" E
`CODEC
`N/
`150
`1 64
`
`t
`
`Analog Signal
`Processor
`126
`
`RF
`Transceiver
`
`Microphone
`160
`
`
`
`Microphone
`Amp 158
`
`Case 3:20-cv-02246-DMR Document 1-3 Filed 04/02/20 Page 10 of 22
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`Stereo
`
`Headphones
`166
`
`ADC
`Controller
`103
`
`Temp Sensors
`Sensors 159 || ".
`
`Mono
`Headset w/
`Microphone
`176
`
`Vibrator
`
`N/
`172
`
`RF
`Switch
`17O
`
`F.G. 6
`
`

`

`U.S. Patent
`
`Aug. 1, 2017
`
`Sheet 8 of 8
`
`US 9,717.464 B2
`
`
`
`Fitness Factor
`
`Central Processing Unit (CPU) or Digital
`Signal
`PrOCeSSOr
`(DSP) Core O
`
`Core 1
`
`Core N
`
`Startup Logic
`
`Management
`Logic
`
`250
`
`26
`
`Application
`Store
`
`Fitness Factor Store
`
`Program Store
`
`Case 3:20-cv-02246-DMR Document 1-3 Filed 04/02/20 Page 11 of 22
`
`FIG. 7
`
`

`

`1.
`CONTINUOUSTRANSIDERMAL
`MONITORING SYSTEMAND METHOD
`
`US 9,717,464 B2
`
`BACKGROUND
`
`10
`
`15
`
`25
`
`Pulse oximetry is a technique known in the art for
`measuring absorbencies in pulsing arterial blood. As one of
`ordinary skill in the art of pulse Oximetry understands, a
`pulse oximeter may also be used to monitor real time heart
`rate and arterial oxygen saturation levels.
`Pulse oximetry works on the basic concept of light
`absorption by hemoglobin, the oxygen carrying molecule in
`red blood cells. Hemoglobin has four oxygen binding sites
`per molecule. The molecule may absorb a certain amount of
`light emitted by a pulse oximeter, based on how many of the
`molecule's oxygen binding sites are bound to an oxygen
`molecule. The intensity of unabsorbed light sensed by the
`pulse oximeter may be used to calculate the amount of
`oxygen bound per hemoglobin molecule. By taking an
`overall average of these sites, the percentage of the total
`blood oxygen Saturation is calculated.
`To accurately monitor light absorption, certain pulse
`oximeters must be placed on the body in an area where the
`skin is thin enough for light to pass through yet has enough
`vascular tissue to generate an acceptable measurement (e.g.,
`ear lobe or tip is an index finger). Certain other pulse
`Oximeters, however, monitor light absorption by measuring
`the amount of light reflected from a user's body, as opposed
`to the amount of light that passes through. Reflective pulse
`Oximeters leverage the fact that hemoglobin molecules
`30
`reflect certain wavelengths of light based on the number of
`oxygen-binding sites that are bound to oxygen and, as such,
`may be placed on the body in areas that have dense capillary
`beds and/or arteries near the skin Surface (e.g., underside of
`the wrist, chest sternum, forehead, etc.).
`Notably, pulse Oximetry measurements, whether taken
`with a “pass-through pulse oximeter or a “reflective” pulse
`Oximeter, are prone to inaccuracies due to electrical noise
`introduced by user movement. The effect of motion artifact
`on the accuracy of a pulse oximetry measurement makes
`pulse oximetry technology known in the art less than ideal
`for real time pulse oximetry monitoring in users that are
`moving, such as athletes, runners, etc. Body movement
`during a reading may provide inaccurate, misleading, or
`ineffective data. Therefore, there is a need in the art for a
`system and method that provides an accurate pulse oximetry
`reading, as well as other physiological calculations and/or
`combinations of physiological calculations, when a user is in
`motion.
`
`35
`
`40
`
`45
`
`SUMMARY OF THE DISCLOSURE
`
`50
`
`Case 3:20-cv-02246-DMR Document 1-3 Filed 04/02/20 Page 12 of 22
`
`The presently disclosed embodiments, as well as features
`and aspects thereof, are directed towards a system and
`method for continuous transdermal monitoring that may
`include measuring pulse Oximetry of a Subject. The pulse
`Oximetry measurement may be intermittent or it may be by
`constant measurement. In some embodiments, the method
`may include measuring the pulse of the Subject at a moment
`during a time interval t, measuring the Subjects acceleration
`at about the moment, and determining whether the pulse
`measured at the moment is at or about a minimized moment
`of Subject acceleration and/or deceleration.
`In an exemplary embodiment, the present disclosure
`includes a system and method for measuring pulse oximetry
`of a subject by interval measurement which includes mea
`Suring an acceleration or deceleration of a body part of a
`
`55
`
`60
`
`65
`
`2
`Subject, determining whether the acceleration or decelera
`tion is within a minimum range, and signaling a pulse
`Oximeter to take a pulse oximetry reading.
`One exemplary method for continuous transdermal moni
`toring begins by monitoring an output signal from an
`accelerometer. The accelerometer output signal may indicate
`acceleration and deceleration of a body part of a user, Such
`as the user's wrist. Based on the accelerometer output signal,
`it may be determined that the body part of the user has
`decelerated to a minimum, e.g., Substantially Zero. With a
`determination that the body part has decelerated to substan
`tially Zero, or has not accelerated beyond Substantially Zero,
`the method may determine a reading from a pulse oximeter
`associated with the accelerometer. Advantageously, the
`pulse oximetry reading, or a reading from other sensors
`associated with the accelerometer, may be optimally accu
`rate as motion artifact may be minimized. The pulse oxim
`etry reading may be recorded for later query and/or rendered
`for the benefit of the user.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`In the drawings, like reference numerals refer to like parts
`throughout the various views unless otherwise indicated. For
`reference numerals with letter character designations such as
`“102A or “102B, the letter character designations may
`differentiate two like parts or elements present in the same
`figure. Letter character designations for reference numerals
`may be omitted when it is intended that a reference numeral
`encompass all parts having the same reference numeral in all
`figures.
`FIG. 1 is a high level functional block diagram illustrating
`an exemplary architecture of a system for continuous trans
`dermal monitoring (“CTM);
`FIG. 2A is an illustration of a users arm motion during
`running, the wrist of the arm depicted with a sensor package
`according to a continuous transdermal monitoring ("CTM)
`embodiment;
`FIG. 2B is a graph illustrating an exemplary single axis
`output from an accelerometer sensor in the sensor package
`depicted in the FIG. 2A illustration;
`FIG. 3 is a logical flowchart illustrating a continuous
`transdermal monitoring (“CTM) method for pulse oximetry
`determination using time stamp comparison;
`FIG. 4 is a logical flowchart illustrating a continuous
`transdermal monitoring (“CTM) method for near real time
`pulse oximetry determination based on accelerometer read
`ings;
`FIG. 5 is a logical flowchart illustrating a continuous
`transdermal monitoring (“CTM) method for generating a
`fitness factor output;
`FIG. 6 is a functional block diagram illustrating an
`exemplary, non-limiting aspect of a portable computing
`device (“PCD) in the form of a wireless telephone for
`implementing continuous transdermal monitoring ("CTM)
`methods and systems; and
`FIG. 7 is a schematic diagram illustrating an exemplary
`Software architecture for continuous transdermal monitoring
`(“CTM) embodiments.
`
`DETAILED DESCRIPTION
`
`Aspects, features and advantages of several exemplary
`embodiments of continuous transdermal monitoring
`(“CTM) systems and methods will become better under
`stood with regard to the following description in connection
`with the accompanying drawing(s). It will be apparent to one
`
`

`

`99 &g
`
`3
`of ordinary skill in the art that the described CTM embodi
`ments provided herein are illustrative only and not limiting,
`having been presented by way of example only. All features
`disclosed in this description may be replaced by alternative
`features serving the same or similar purpose, unless
`expressly stated otherwise. Therefore, numerous other
`embodiments of the modifications thereof are contemplated
`as falling within the scope of the present invention as defined
`herein and equivalents thereto. Hence, any use of absolute
`terms such as, for example, “will.” “will not,” “shall,” “shall
`not,” “must and “must not are not meant to limit the scope
`of the disclosure as the particular CTM embodiments dis
`closed herein are merely exemplary.
`The word “exemplary” is used herein to mean serving as
`an example, instance, or illustration. Any aspect described
`herein as “exemplary' is not necessarily to be construed as
`exclusive, preferred or advantageous over other aspects.
`In this description, the term “application' may also
`include files having executable content, such as: object code,
`Scripts, byte code, markup language files, and patches. In
`addition, an “application” referred to herein, may also
`include files that are not executable in nature, such as
`documents that may need to be opened or other data files that
`need to be accessed.
`In this description, the terms “subject,” “patient” and
`“user are used interchangeably unless otherwise noted.
`Specifically regarding the term “user,” a user may be a
`Subject or patient to which a sensor package is associated or,
`in some embodiments, a user may also be a person associ
`ated with a hub device and/or a remote server. Notably, a
`user of a hub device and/or a remote server may also be a
`user associated with a sensor package.
`As used in this description, the terms “component.”
`“database.” “module.” “system,” and the like are intended to
`refer to a computer-related entity, either hardware, firmware,
`a combination of hardware and software, software, or soft
`ware in execution. For example, a component may be, but is
`not limited to being, a process running on a processor, a
`processor, an object, an executable, a thread of execution, a
`program, and/or a computer. By way of illustration, both an
`application running on a computing device and the comput
`ing device may be a component.
`One or more components may reside within a process
`and/or thread of execution, and a component may be local
`ized on one computer and/or distributed between two or
`more computers. In addition, these components may execute
`from various computer readable media having various data
`structures stored thereon. The components may communi
`cate by way of local and/or remote processes such as in
`accordance with a signal having one or more data packets
`(e.g., data from one component interacting with another
`component in a local system, distributed system, and/or
`across a network Such as the Internet with other systems by
`way of the signal).
`In this description, the terms “central processing unit
`(“CPU”),” “digital signal processor (“DSP”),” “graphical
`processing unit (“GPU”),” “processing component' and
`“chip' are used interchangeably. Moreover, a CPU, DSP
`GPU or chip may be comprised of one or more distinct
`processing components generally referred to as "core(s).'
`In this description, the term “portable computing device'
`(PCD) is used to describe any device operating on a
`limited capacity power Supply, such as a battery. Although
`battery operated PCDs have been in use for decades, tech
`nological advances in rechargeable batteries coupled with
`the advent of third generation (3G”) and fourth generation
`(“4G”) wireless technology have enabled numerous PCDs
`
`Case 3:20-cv-02246-DMR Document 1-3 Filed 04/02/20 Page 13 of 22
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`with multiple capabilities. Therefore, a PCD may be a
`cellular telephone, a satellite telephone, a pager, a PDA, a
`Smartphone, a navigation device, a Smartbook or reader, a
`media player, a combination of the aforementioned devices,
`a laptop computer with a wireless connection, a remote
`sensor package worn by a user, among others.
`In this description, exemplary embodiments of a continu
`ous transdermal monitoring system are described to com
`prise a motion sensor in the form of an accelerometer.
`Notably, specific reference to a motion sensor in the form of
`an accelerometer is not meant to limit the scope of the
`disclosure or otherwise suggest that a CTM embodiment
`must include an accelerometer. For instance, it is envisioned
`that CTM embodiments that include a motion sensor may, in
`fact, include an accelerometer but may, alternatively or
`additionally, include other motion sensing devices such as a
`gyrometer, a global positioning system (“GPS) or the like.
`Other devices and combinations of devices for sensing
`motion other than accelerometers are envisioned. As such,
`one of ordinary skill in the art will recogonize that reference
`to an accelerometer in this description is for illustrative
`purposes only and is not meant to Suggest that all CTM
`embodiments must include specifically an accelerometer.
`Continuous transdermal monitoring (“CTM) embodi
`ments, as well as features and aspects thereof, are directed
`towards providing a system and method for measuring pulse
`Oximetry of a subject by constant measurement which may
`include measuring the pulse of the Subject at a moment
`during a time interval t, measuring the Subject’s acceleration
`at or about the moment, and determining whether the pulse
`measured at or about the moment is at or about a minimized
`moment of subject acceleration, e.g., a minimum accelera
`tion. Certain CTM embodiments may also monitor via one
`or more sensors any number of physiological and/or non
`physiological parameters associated with the Subject includ
`ing, but not limited to, pulse rate, blood oxygen saturation,
`transdermal core temperature, Global Positioning System
`(“GPS) coordinates, 3-axis accelerometer outputs, skin and
`ambient temperature readings, hydration levels, and baro
`metric readings.
`Certain CTM embodiments may include a pulse-oximeter
`in a sensor package that utilizes reflective, light-absorption
`technology. The pulse oximeter sensor may be configured to
`transmit light at two different wavelengths, such as for
`example 660 nm and 940 nm, through the skin and into an
`artery of a user. As one of ordinary skill in the art would
`understand, some of the transmitted light may be reflected
`and, based on the amount of light reflected and sensed by the
`pulse oximeter sensor, used to calculate pulse rate and
`arterial blood oxygen Saturation. The sensor package of a
`CTM embodiment may be placed on the wrist and worn like
`a wristwatch. Other CTM embodiments may include a
`sensor package that is integrated into sports equipment Such
`as wristbands, Sweatbands, braces, shoulder pads, helmets,
`mouthpieces, etc. By having a durable encasement and a
`monitoring system that accounts for movement, the circuitry
`within the sensor package, and the integrity of the data it
`generates, may be protected from impact and movement.
`It is envisioned that a sensor package of a CTM embodi
`ment may be placed on the body of a user over any artery or
`arterial bed. Such as the forehead, ear, bicep, ankle, etc. As
`Such, the particular location of a sensor package, as applied
`to a user, will not limit the scope of a CTM embodiment. For
`example, in a football application, the sensor package may
`be implanted into the front of a player's helmet and targeted
`at the forehead, or integrated into the player's shoulder pads
`right over the sternum. Both the forehead and the sternum
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`offer Superficial arterial beds that may present an opportu
`nity to yield good accuracy in reflective pulse oximetry
`measurement, as would be understood by one of ordinary
`skill in the art of pulse Oximetry. As another example, in an
`application for use by a patient in a hospital, it is envisioned
`that the sensor package of a CTM embodiment may be worn
`on the wrist or ankle for ease of use.
`A CTM embodiment may include components in addition
`to a pulse oximeter to track a user's motion and Surrounding
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`environment. For example, it is envisioned that a CTM
`embodiment may include a GPS sensor and accelerometer
`for monitoring movement, distance, Velocity, and accelera
`tion of the user. Moreover, some embodiments may include
`combinations of a barometer, skin and ambient temperature
`probe, core temperature sensor, and a hydration sensor for
`monitoring a user's elevation during a workout, ambient
`temperature exposure, skin temperature and Sweat-fluid
`composition along with the athlete's core body temperature.
`Certain embodiments may also include a UV sensor for
`monitoring the user's Sun exposure. Using one or more
`readings generated by the sensors, a user's blood pressure
`may be estimated using linear regression. The accelerometer
`may also be used to determine the amount of time the user
`sleeps by tracking movement. All of these readings may be
`taken in real time and relayed wirelessly to a portable
`computing device, or other computing device, such as a
`Smartphone or computer.
`Certain CTM embodiments may include an integrated
`light emitting diode (“LED) screen which may render
`continuous information to the user of the CTM embodiment.
`A CTM embodiment may be equipped with programmable
`alarms that may sound if any reading recognized by the
`sensor package falls outside of a desired, preset range.
`Notably, it is envisioned that certain CTM embodiments
`may leverage a single computing device, or 'hub' device, in
`communication with two or more sensor packages, thereby
`providing for a single user to monitor several other users
`associated with a sensor package.
`It is envisioned that some CTM embodiments may
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`include a hub device. Such as a portable computing device
`that is communicatively linked to one or more sensor
`packages using Bluetooth or another short wave radio sig
`nal. Certain CTM embodiments may store data collected by
`a sensor package, output data to a user in real time, transmit
`collected data to a remote device Such as a server, or any
`combination thereof. The collected data may be leveraged
`by certain CTM embodiments to generate a general fitness
`factor from a weighted computation of multiple sensor
`outputs. It is envisioned that the fitness factor output may be
`generated by algorithms that are customized by the user Such
`that certain data inputs are weighted according to user
`selection.
`In exemplary CTM embodiments, the fitness factor may
`be calculated from an algorithm based on data gathered from
`one or more studies that quantify various heart rate levels
`during and after exercise. A user's core temperature reading
`taken in correlation with the heart rate readings, along with
`other physiological readings from a sensor package Such as
`blood pressure and oxygen Saturation, may contribute to
`calculation of a fitness factor according to a fitness factor
`algorithm in a CTM embodiment. Moreover, individual
`metrics such as metabolic expenditure, resting heart rate,
`maximum heart rate, gender, age, heart rate variability, heart
`rate recovery, height, weight, and other metrics may also be
`tracked and incorporated into the fitness factor in some
`embodiments.
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`As described above, it is envisioned that a fitness factor
`may be calculated based on a statistically verified weighted
`scoring system composed of the various health metrics input
`by a user and/or monitored and tracked by a sensor package/
`hub device. The Software package may generate data that
`may inform a care-giver or patient or athlete about a general
`fitness level, thus allowing a user to customize activities. For
`instance, a football team using a CTM embodiment may
`determine how demanding practice should be for a given
`week based on the players’ average fitness level according
`to outputs generated by a fitness factor algorithm. Similarly,
`a fitness factor algorithm according to a CTM embodiment
`may provide an individual user with a unitless output against
`which to measure improvement of a general physical fitness
`level.
`A CTM embodiment may feature onboard memory stor
`age as well as a wireless transmitter in order to store and/or
`send real time output data. The antenna for the wireless
`transmitter and the printed circuit board may be flexible and
`embedded along the curvature of a component of the CTM
`embodiment, such as a sensor package. As previously
`described, a sensor package component of a CTM embodi
`ment may include any number of onboard sensors including,
`but not limited to, a 3-axis accelerometer, GPS receiver,
`barometer, ambient and skin temperature gauges, hydration
`sensor, core body temperature sensor and a reflective pulse
`Oximeter. Notably, any combination of the sensors may
`reside within a sensor package and/or a hub device of a CTM
`embodiment.
`Certain CTM embodiments may include algorithms for
`collecting accurate pulse oximetry readings, as well as other
`sensor readings, by minimizing the effects of motion artifact
`errors when the reading(s) is taken. An exemplary algorithm
`involves measuring when user motion and/or movement is at
`a minimum. Based on a preset input defining what consti
`tutes minimum movement, readings from an accelerometer
`and/or other methods of position measurement may be used
`to recognize when user movement is at a minimum. Con
`sequently, a CTM embodiment may recognize readings
`taken from other sensors at a point in time that is close to the
`time of minimal user movement as being accurate. In Such
`an embodiment, for example, an accelerometer in a sensor
`package may be effectively functioning as the on/off control
`for the oximeter sensor, i.e. the accelerometer outuput may
`trigger the pulse oximeter sensor to take a reading when user
`movement is at a minimum, and vice versa.
`A pulse oximeter included in a sensor package component
`of a CTM embodiment may comprise a red LED that may
`be pulsed for approximately 50 microseconds then turned
`off. Subsequently, after 450 more microseconds an infrared
`LED may be pulsed for approximately 50 microseconds then
`turned off After 450 more microseconds, the red LED may
`be turned back on and the cycle may repeat. The duration of
`the pulse oximeter cycle may be programmable and there
`fore subject to change in some CTM embodiments. Once the
`light generated by the LEDs is reflected off of an artery or
`artery bed of a user, it may be absorbed by a photodiode
`which may emit a small current of a few micro amps, as
`would be understood by one of ordinary skill in the art. The
`current may be sent to a transimpedance amplifier, some
`times referred to as an op-amp, which may convert the few
`micro-amps of current into a few millivolts, as is understood
`by one of ordinary skill in the art of electronics. The signal
`may then be sent to a bandpass pass filter that may filter out
`all the noise above 5 Hz and below 0.5 Hz. This may allow
`a pulse rate resolution of as low as 20-30 beats per minute
`and as high as 300 beats per minute in some CTM embodi
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`CTM embodiment may feature a strap or some other means
`to tighten the embodiment down in order to prevent and/or
`limit movement or slippage relative to a user's person. Any
`component may also be made elastic or form fitting to
`possibly eliminate the strap. For instances when one or more
`components of a CTM embodiment is integrated into sports
`equipment, it is envisioned that the electronics may be
`protected by that equipment. A helmet may have the device
`imbedded into the padding over the forehead, and a wrist or
`ankle brace/guard may have the device sewn into the fabric
`and protected by the brace or guard itself, for example. A
`mouthpiece may be designed with the device molded into it,
`as could an earpiece perhaps used for communication
`between teammates. Integration into any and all possible
`sports equipment is envisioned.
`Exemplary CTM embodiments, as well as features and
`aspects thereof, are directed towards providing a system and
`method for measuring pulse Oximetry of a Subject by con
`stant measurement which includes measuring the pulse of
`the Subject at a moment during a tim