(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`
`(19) World Intellectual Property Organization
`Inlemational Bureau
`
`(43) International Publication Date
`26 January 2006 (26.01.2006)
`
`(51) International Patent Classification:
`A613 51’00 (2006.01)
`
`(21) International Application Number:
`PCTr‘I I52005i02 1433
`
`[22) International Filing Date:
`(25) Filing Language:
`
`17 June 1005 (17.06.2005)
`English
`
`(26) Publication Language:
`
`[English
`
`(30') Priority Data:
`605 80,97]
`
`18 June 2004 ( l8.06.2004)
`
`US
`
`(71) Applicant (for at! designated States except US): VIVO-
`METRICS INC.; 121 N. Fir Street. Suite E. Ventura. CA
`93001 (US).
`
`Inventors; and
`lnventorsiApplicants {for US oniyl: BEHAR. Andrew
`[USJUSh 1105 North Signal Street, Ojai. CA 93033 (115').
`C033,,Iei'f |USIUS]; 1590 Burnside Drive. Ventura. CA.
`93004 {US}. DERCHAK, Alex; 9 Beekman 'l‘crrace. Sum—
`mit. NJ 07901 [1151.KEENAN. Barry; 5185 Kara Drive,
`Santa Barbara. CA 931! | (US). DARNAI.L, Dave; Ven-
`tura, CA {US}.
`
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`llll
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`(10} international Publication Number
`
`WO 2006/009830 A2
`
`(81) Designated States (tiniess otherwise indicated for every
`kind ofmttiottai protection awaiiabie): AE. AG. AL. AM,
`AT. A11, AZ. BA, BB, BG, BR, BW. BY. BZ,CA, (311. CN,
`CO. CR. CU.
`DE. DK. DM. DZ. 13C. 1515. L5G. US. FL
`GB. GD. (iii. GH. GM, HR. HU. ID, IL. IN. 15. ll). K15.
`KG. KM, KP. KR. KZ. LC. LK. LR. LS. LT. LU. LV. MA.
`MD, MG. MK. MN. MW, MX. MZ. NA, NG, NI. NO. NZ,
`OM, PG. PH, PL. PT, RO. RU. SC, SD. SE. SG, SK. SL,
`SM. SY. '1], TM. TN, TR, 'I'l'. '17.. UA. UG, US. U35. VC.
`VN.Y1J.ZA,ZM,ZW.
`
`Designated States (enters otherwise indicated. for every
`kind afregionai protection avaiiabie): ARIPO (BW. Gil,
`GM. Kll, LS. MW. MZ. NA, SD. SL. SZ, 17.. UG. ZM.
`KW). [Eurasian (AM. AZ. BY. KG, KZ, MD. RU. '1‘]. TM).
`European (AT. Bli, 86. C11. CY, CA. Dli, DK. 1111i, IES. i-‘l,
`FR.GB, GR, H'U, 111', IS, l’l'. LT. LU. MC. NL. PL. PT, RO,
`SE, SI. SK. TR), OAPI (BF. BJ, CF. CG. CI. CM. GA, GN,
`GQ, GW, ML. MR, Nli, SN. Tl), TGJ.
`
`Published:
`without international search report and to be repubiisited
`upon racer)” of that report
`
`US. Patent No. 892394
`
`190
`57) Abstract: The present invention provides systems and methods for monitoring in real time the physiological status clone or
`I‘D more subjects. especially subject engaged in potentially harardous or dangerous activities. Systems include wearable items with one
`a or more physiological sensors and a local data unit (LDU') operatively coupled to the sensors. The LDUs digitize and filter sensor
`a data. extract physiological parameters. determine abnormal or not aoccptahie physiological Condilions. and communicate to exlcr—
`nal monitoring facilities. The external facilities displa},r status and data concerning monitored subjects. In preferred embodiments.
`communication between the LDUs and the external monitoring facilities dynamicain adjusts to the condition of the subjects and to
`system changes such as subjects and external facilities entering and leaving andi‘or moving from place to place. The invention aiso
`provides program products for performing this inventions methods.
`
`Agent: RENFREW, Dwight, 1-1.. Ohlandl. Greeley. Rug—
`giero & Perle, LLP. One Landmark Square, 10th Floor.
`Stamford, CT 06901-2982 (US).
`
`For two-ietter coder and other abbreviations. refer to the "Guid-
`ance Notes rm Codes artdtibbreviatimrs“ appearing at the begirtv
`Hing {Jester}: regular issue of tile PUP Gazette.
`
`
`
`9830A2||||||||||||||||||||||||||||||||||||||||||
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`(54) Title: SYS’I'IEMS AND METHODS FOR RliAerlMii PHYSIOLOGICAL MONITORING
`
`APL106
`
`Apple Inc.
`APL1061
`U.S. Patent No. 8,923,941
`
`I
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`FITBIT, Ex. 1061
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`SYSTEMS AND METHODS FOR REAL-TIME PHYSIOLOGICAL MONITORING
`
`l.
`
`FIELD OF THE INVENTION
`
`[0001] The present invention provides improved systems and methods for real-time monitoring
`
`and display of physiological data obtained from monitored subjects; in preferred embodiments,
`
`the invention dynamically accommodates to changing locations of both monitored subjects and
`
`monitoring personnel; physiological data includes information of respiration, cardiac activity,
`
`posture, physical activity, temperature, or the like.
`
`2.
`
`BACKGROUND OF THE INVENTION
`
`[0002] Real-time monitoring and display of physiological data from monitored subjects is now
`of interest in many fields of endeavor. For example, such monitoring can be useful where the
`
`operation in field conditions.
`
`monitored subjects are in potentially stressful or hazardous situations. Such situation occur in
`
`the military, in first responder professions such as firefighters, rescuers, police and the like,
`
`industrial settings, and so forth. This inventiOn has other applications in competitive athletics
`
`during training, and competition; and in non-competitive but potentially hazardous recreations
`
`such as diving, caving, and the like; and so forth.
`
`[0003] Systems and methods for real-time physiological monitoring are knewn in the prior art.
`
`For example, US. patent no. 6,1983 94 B1 (the '394 patent), filed December 5, 1996, discloses a
`
`system for remote monitoring directed to military applications. It describes systems that require
`
`subjects to wear a military~type harnesses that carry a variety of sensors and communication
`
`equipment. However, such military-grade equipment designed for battlefield use has limited
`
`appeal in other applications.
`
`[0004] Other prior-art monitoring systems and methods can be more appealing for non-military
`
`use. For urample, US. patent no. 6,047,203 (the '203 patent), filed April 4. 2000, discloses a
`
`monitoring system in_which innovative physiological sensors are arranged in comfortable and
`
`unobtrusive garments of various types and can provide quantitative data on cardiac, respiratory,
`
`and other physiologic systems. However, such systems have not been adapted to real-time
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`{0005] Thus, that prior art lacks monitoring systems that previde quantitative physiological data
`
`in real—time using subject-monitoring technologies appealing to a broad range of monitored
`
`subjects.
`
`3.
`
`SUMMARY OF THE INVENTION
`
`[0006] Objects of the present invention include overcmning this lack in the prior art by providing
`
`monitoring systems and methods that gather quantitative physiological data in real-time by
`
`means of subject-monitoring technologies that are appealing to a broad range of monitored
`
`subjects.
`
`-2-
`
`that can be in, turn directed to different applications. Generally, system sensors include one or
`
`[0007] Systems of this invention preferably include one or more monitoring apparatus carrying
`
`sensors for monitoring individual subjects, and local electronic module or modules (known as
`
`local data units (LDUD for acquiring data from the monitoring apparatus (collectively, '
`
`"monitoring apparatus"). Preferably, sensors are arranged in or carried by a wearable item that
`
`can be comfortabl y worm by a monitored subject. Wearable items can be garments of various
`
`types, belts, caps, patches, and the like. Sensor can be arranged in Or carried by a wearable item,
`
`for example, by being arranged in (open or closed) pockets, by being attached to a garment, as by
`
`Sewing, gluing, Velcro, and the like, or by being integral to the garment. In the latter case, the
`
`garment can serve as all or part of one or more sensors, or can include active components such as
`
`conductive threads, stretchable loops, contacts, and so forth. The LDU operates sensors if
`
`needed, gathers sensor signals by conductive wires, threads, or other elements, or by wireless
`
`links local to the monitored subjects. It preferably also preprocesses sensor data, stores sensor
`
`data, transmits sensor data for remote use, determines selected physiological parameters, checks
`
`parameters for conditions indicating warnings or alarms, displays selected data to monitored
`
`subjects, and the like.
`
`.
`
`[0008] Many different types of sensors can be present in different embodiment of this invention
`
`more of the following types: sensors for respiratory functions; sensors for cardiac functions;
`
`sensors for blood oxygen saturations; sensors for. subject posture, subject activity, and the like;
`
`sensors for skin temperatures, sensors for electroencephalographic signals; and so forth. In
`
`certain applications, sensors can also include ballistic impact microphones for registering
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`impacts received by a monitored subject that may indicate bodily injury. Sensors can be based
`
`on the various technologies known in these arts. Preferred sensors for respiratory function are
`
`based on inductive plethysmographic technology that measures respiratory motions of the
`
`subject thorax and/or abdomen. Preferred sensors for cardiac function are based on electrical
`
`detection of heart activity, and/or also on plethysrno graphic technology that measures cardiac or
`
`vascular pulsations. Preferred sensors for posture and activity are based on processing data from
`
`one or more accelerometers mechanically coupled to the subject
`
`[00091 LDUs gather, preferably process, and communicate sensor data.
`
`lfappropriate sensor
`
`data is gathered, LDUS preferably extract respiration rate, and/or heart rate, and/or body
`
`temperature, and/or posture, and/or indieia of activity, and/or oxygen saturation. LDUs can
`
`extract other or additional phySiological parameters that may be appropriate for particular
`
`applications of this invention. For example, tidal volume and minute ventilation can be extracted
`
`from plethysmogjraphic respiratory data. Preferably, LDUs also determine and check selected
`
`conditions indicating physiological distress or danger. More simple alarm conditions can be
`
`checked by comparing individual, extracted physiological parameters against normal ranges and
`
`bounds. More complex alarm conditions can be checked by comparing and/or correlating
`
`combinations of two or more physiological parameters against joint bounds orjoint ranges.
`
`LDUs also preferably display, audibly indicate, or otherwise make monitored subjects aware of
`
`-3-
`
`communicate with local monitoring facilities that process and display data fmm communicating
`
`their current physiological status.
`
`[0010] LDUs also preferably communicate some or all of the gathered physiological data to
`
`external monitoring facilities. External monitoring facilities can be near, for example less than
`
`hundreds of meters from, monitored subjects; or can be in the vicinity of, for example from
`
`hundreds to thousands of meters fi'om, monitored subjects; or can be remote, for example more
`
`than thousands of meters from, monitored subjects. For example, LDUs may wirelessly
`
`LDUs. Also, the local monitoring facilities may communicate by wireless or wired links to
`
`remote monitoring facilities than can further process and display data from communicating local
`
`monitoring facilities. Also, LDUs can directly communicate with remote monitoring facilities
`
`by, for example, being in wireless communication with access points having wired links to the
`
`remote monitoring facilities. This invention‘s systems can include additional types of external
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`monitoring facilities and/or communication nodes. LDUs, external monitoring facilities, and
`
`other system elements also preferably cooperate to store sensor data and its interpretation for
`
`later analysis and/or audit.
`
`[0011] In preferred embodiments, these communication links and communication patterns are
`
`dynamically established in response to current locations of LDUs, local monitoring facilities, and
`
`remote monitoring facilities (collectively, "system elements"). Since in the field locations of
`
`these system elements can change over time and often in unpredictable ways, it is also preferred
`
`that System communications adapt dynamically to such location changes.
`
`It is also preferred that
`
`system elements communicate in both directions, so that messages and processed data can be
`
`conveyed to LDUs and sensor data is being conveyed to external monitoring facilities.
`
`[0012] In many embodiments communication bandwidth, especially wireless bandwidth, is
`
`limited, and it is therefore preferably that in normal circumstances LDUs not transmit all sensor
`
`data to local or remote monitoring facilities (and similarly for transmission between separate
`
`external monitoring facilities).
`
`In onepreferred embodiment, LDUs periodically transmit only
`
`' brief "0K" messages as long as no danger, warning, or other exceptional conditions id detected.
`
`from said physiological information from said locations local to said monitored subjects to a
`
`Alternatively, LDUs can also transmit some or all of the physiological parameters extracted from
`the sensor data.
`In this embodiment, if a danger, warning, or exceptional condition is detected,
`
`then LDUs begin to transmit increasingly detailed data concerning the cause of the condition (if
`
`it can be determined). For example, the nature and severity ofa detected c0ndition can be then
`
`transmitted. For more severe conditions, LDUs can transmit some or all of the original sensor
`
`data.
`
`[0013] Generally, methods of this invention monitor subjects engaged in ambulatory activities
`
`by processing physiological sensor data obtained from each ambulatory monitored subject at a
`
`location local to that subject and separately from other monitored subjects in order to determine
`
`physiological information comprising indication of whether a physiological state of said subject
`
`is normal or not andfor is acceptable or not; then by presenting one or more of said monitored
`
`subjects items selected from said physiological information; then by transmitting items selected
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`FITBIT, Ex. 1061
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`

`

`[0014] Monitored subjects can be in potential and/or actual physiological stress such as subject
`
`to heat stress, anxiety, panic, dehydration, and disorientation. Subjects' ambulatory activities
`
`include daily-living activities, and/or employment activities, and/or professional activities,
`
`military activities, police activities, firefighting activities, rescue activities, industrial activities,
`
`athletic competition activities, athletic training activities, and recreation activities.
`
`[0015] Physiological parameters of interest comprise one or more parameters selected from the
`
`group consisting of parameters describing a subject's respiratory function, parameters describing
`
`a subject's cardiac function, parameters describing a subject's posture, parameters describing a
`
`subj ect's activity, parameters describing a subj ect‘s energy consumption, and parameters
`
`describing a subject's temperature. Physiological state can be determined by comparing
`
`individual parameters to pro-determined ranges of values, or by combining multiple parameters,
`
`e.g., by statistical regression functions, and comparing the combined values to pro-determined
`
`regions of parameter space. A subject's ventilatory threshold is preferred for establishing
`
`acceptable ranges of exertion.
`
`locations"), transmitted items are preferably selected in dependence on whether or not said
`
`physiological state is acceptable or not and/or is normal or not. For acceptable or normal
`
`subjects, little more than indication ofnormalcy can be transmitted. For other subjects,
`
`transmitted items can include some or all of said sensor data and/or said physiological
`
`information. And in order to allow flexible use of this invention in unpredictable field
`
`conditions, it is preferred than communication between its elements, e.g., those local to a subject
`
`and external remote facilities, by established and configured dynamically. Accordingly, different
`
`system elements can select the other system units with which to communicate, for example,
`
`depending on signal clarity or strength or upon unit priority, or the like. Preferably, one external
`
`remote facility can be designated, e.g., by priority, as a primary facility to eventually receive
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`location remote from said monitored subjects; and finally by displaying at said remote location
`
`some or all of said transmitted physiological concerning said monitored subjects.
`
`information on all monitored subjects.
`
`[0016] In order not to overload remote external monitoring facilities (also referred to as "remote -
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`[0017] Preferred system elements include portable monitoring apparatus for real-time .
`
`monitoring of an ambulatory subject that includes a wearable item comprising one or more
`
`sensors, said sensors providing one or more signals l‘CSpOIlSive to the physiology of an
`
`ambulatory subject wearing said item; and a portable data unit local to said wearable item
`
`comprising a processing device that performs retrieval and processing said sensor signals in
`
`order to determine physiological information comprising indication of whether a physiological
`
`state of said subject is normal or not and/or is acceptable or not; presentation to a wearer items
`
`selected from said physiological infomtalion; and transmission items selected from said
`
`physiological information from said portable data unit to a location remote from said portable
`
`data unit, said items selected in dependence on said physiological state of said monitored subject
`
`[0018] Preferred system elements also include external monitoring facilities for real-time
`
`monitoring of ambulatory subjects including displays; communication interfaces for wireless
`
`communication; and a processing device operativer coupled to said display and to said
`
`communication interface that establishes communications with one or more portable monitoring
`
`computer instructions for performing the invention's methods.
`
`apparatus, each portable monitoring apparatus monitoring an ambulatory subject and wirelessly
`
`transmitting physiological information concerning said subject, and receives transmitted
`
`physiological information concerning one or more monitored subjects; and displays selected
`
`items of received physiological information. External facilities generally communicate both with
`
`portable monitoring apparatus and with other external facilities. 7!. A system for real-time
`
`monitoring of ambulatory subjects comprising:
`
`[0019] A system of this invention includes these elements c00peratively communicating. for real-
`
`time manitoring of ambulatory subjects, namely one or more portable monitoring apparatus; and
`
`one or more external monitoring facilities so that said portable monitoring apparatus wirelessly
`
`communicate with at least one of said external monitoring facilities, and wherein at least one
`
`external monitoring facility wirelessly communicates with at least one other external monitoring
`
`facility, and wherein said wireless communicatiori comprises physiologiCal information
`
`describing ambulatory subjects monitored by said portable monitoring apparatus.
`
`[0020] The invention also includes program products with computer readable media containing
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`[0021] A number of references are cited herein, including patents and published patent
`
`application, the entire disclosures of which are incorporated herein, in their entirety, by reference
`
`for all purposes. Furlher, none of these references, regardless of how characterized above, is
`
`admitted as prior to the invention of the subject matter claimed herein.
`
`[0022] Specific embodiments ofthis invention will be appreciated from the following detailed
`
`descriptions and attached figures, and various of the described embodiments are recited in
`
`appended claims.
`
`4.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[0023] The present invention may be understood more fully by reference to the following
`
`detailed description of preferred embodiments of the present invention, illustrative examples of
`
`specific embodiments of the invention, and the appended figures in which:
`
`[0024] Figs. lA-C illustrates wearable items with sensors;
`
`[0025] Figs. ZA-B illustrate embodiments of realstime monitoring systems;
`
`[0026] Figs. 3A-F illustrate alternative displays of monitored sensor data;
`
`[0027] Figs 4A—B illustrate processing at the monitored subject; and
`
`[0028] Fig. 5 illustrates processing external to the monitored subject.
`
`[0029] Figs: 6A-B illustrate exemplary accelerometer data for a subject; and
`
`[0030] Fig. 7' illustrates ventilatory thresholds (referred to herein as "Tvent").
`
`convonience only.
`
`[0031] Preferred embodiments of the systems and methods of this invention are described in the
`
`5.
`
`DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
`
`following.
`
`In the following, and in the application as a whole, headings are used for clarity and
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`5.2.
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`SYSTEM COMPONENTS
`
`[0032] System components of the present invention include: monitoring apparatus with
`
`physiological sensors, wearable items carrying these sensors, local data units ("LDU"), and so
`
`forth; local or remote monitoring facilities with compute, data display (for monitoring
`
`personnel), and data storage capabilities; and communications between these compenents.
`
`Preferred embodiments of these components are described in this subsectiOn.
`
`possible to obtain indicia of cardiac stroke volumes, indicia of respiratory tidal volume and
`
`placed at various levels about the thorax, abdomen, and other body parts of a monitored subject.
`This time-varying loop inductance reflects primarily indicia of time-varying cross-sectional areas
`
`WEARABLE SENSORS AND GARMENTS
`
`{0033} Monitoring apparatus preferably comprises a wearable item or items, such as a garment,
`
`shirt, vest, chest strap, patch, cap, or the like, in or on which physiological sensors are disposed.
`
`Appropriate sensor technOIOgies and their dispositions on monitored subjects are preferably
`
`chosen jointly so that resulting apparatus (for example, monitoring garments) are unobtrusive,
`
`comfortable, and even appealing to monitored subjects while providing reliable, real-time
`
`I physiological monitoring data. Weight is an important aspect of comfort, and it is preferred that
`
`the monitoring apparatus and any associated electronics (e.g., LDUs) be leSs than about 800 g,
`
`more preferably less than 700 g, and even more preferably less than 600 g or 500 g or lighter.
`
`[0034] One preferred respiratory andfor cardiac sensor technology is inductive plethysmography
`
`(1P), which has been clinically confirmed to provide reliable, quantitative data on at least
`
`respiratory and cardiac fimctions.
`
`[P senSOrs can be disposed on monitored subjects in various
`
`kinds of garments, for example, in bands, or in partial-shirts, or in shirts, or on partial body suits,
`
`or in full body suits, or in caps, and the like. IP-based sensors function by measuring time—
`
`varying inductance of conductive loops (ofien configured in elastic, expandable bands) that are
`
`enclosed by theso loops, and using signal processing and pattern recognition techniques with
`
`reference to established physiological models (such as a two-compartment mode} of respiratory
`
`volumes), these indicia of cross-section areas can be processed to yield indicia or measures of
`
`physiological functions and/or times of occurrences of physiological events. For example, it is
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`

`[0035} However, IP-based sensors are preferred and not limiting, and this invention can readily
`
`employ sensor based on alternative technologies. Certain alternative sensor technologies make,
`
`similar to lP-based sensors, make measurements reflecting cross-sectional areas, or
`
`circumferences, or their geometric equivalents, or measurement that can be converted into such
`
`information (for example, stress or strain of an expandable 100p about the subject), at one or
`
`more levels through the thorax, abdomen, or other body structures, and at sample rates up to 200
`
`Hz. Data from IP and alternative sensors can then be processed by the methods that have been
`
`developed for IP signals. For example, alternative sensors can be based on thread and fabric
`
`technologies being and to be deveIOped: a sensor may measure the resistance of conductive
`
`threads having strain-dependent resistance that are incorporated into garments or bands; or a
`
`sensor may Optically or electrically means the local stress of a fabric woven so that local stress
`
`reflects length andfor circumferential. For another example, alternative sensors may use energy
`
`radiation (such as ultrasound radiation, or electric fields, magnetic fields, or electromagnetic
`
`radiation) to measure geometric parameters (such as distances) through body structures.
`
`[0036] However, for brevity and concreteness only, the subsequent description will be largely in
`
`terms of preferred 1P sensor technologies and of processing methods sensitive to body cross
`
`sectional area (or circumference, or the equivalent). Details of the preferred 1? technology, its
`
`disposition in garments, its processing and interpretation, and certain closely allied sensor
`
`technologies is described from the following U.S. patents (collectively, the "lP patents"), all of
`
`which are incorporated by reference in the entireti es herein for all purposes and are assigned to
`
`the assignec of this application. Patents disclosing EP technology and its disposition in fabrics
`
`and garments (collectively, the "sensor and garment patents") include U.S. patent no. 6,551,252,
`
`filed April 17, 2001 (an improved ambulatory 11" system and sensor garment); U.S. patent no.
`
`6,341,504, issued January 29, 2002 (stretchable conductive fabric for IP sensors); U.S. patent no.
`
`6,047,203, issued April 4, 2000 (an ambulatory [P system including a sensor garment); U.S.
`
`patent no. 5,331,968, issued July 26, 1994 (1? sensors and circuitry); U.S. patent no. 5,301,678,
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`minute ventilation, occurrence times of respiratory events, such as apneas, and the like, and so
`
`forth.
`
`'
`
`issued April 12, 1994 (stretchable 1P transducer); and U.S. patent no. 4,807,640, issued February
`23, I989 (stretchable 1P transducer).
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`[0037] Patents disclosing processing of IP signals to obtain measures of respiratory function
`
`(collectively, the "data processing and interpretation patents") include U.S. application no.
`
`(TBD) (by Coyle et al.; titled "Systems and Methods For Object-based Monitoring Physiological
`
`Parameters"; current attorney docket no. 10684-035999), filed June 6, 2004 (improved methods
`
`for processing respiratory 1P signals and for detecting respiratory events from processed signals);
`
`U.S. application no. 1011451097, filed June 6, 2004 (object oriented methods for monitoring of
`
`physiological parameters); US. patent no, 6,413,225, issued July 2, 2002 (improved methods for
`
`calibrating 1P breathing monitors); U.S. patent no. 6,015,388, issued Jan. IS, 2000 (methods for
`
`measuring respiratory drive providing various outputs, including control signals for mechanical
`ventilators or continuous positive air pressure (CPAP) devices); U.S. patent no. 5,159,935, issued
`
`-10-
`
`November 3, 1992 (measarements of individual lung fianctions); U.S. patent no. 4,860,766,
`
`issued Aug. 29, 1989 (noninvasive methods for measuring and monitoring intrapieural pressure
`
`in newborns by surface 11‘ of cranial bones); US. patent no. 4,834,109, issued May 30, 1989
`
`(methods for calibrating [P breathing monitors); U.S. patent no. 4,815,473, issued March 28,
`
`1989 (methods for monitoring respiration volumes); U.S. patent no. 4,777,962, issued Oct. 18,
`
`1988 (methods and systems for distinguishing central, obstructive, and mixed apneas from
`
`signals which monitor the respiratory excursions of the rib cage and the abdominal); U.S. patent
`no. 4,648,407, issued Mar. 10, 1987 (methods for detecting and differentiating central and
`
`obstructive apneas in newborns); U.S. patent no. 4,373,534, issued February 15, [983 (methods
`
`for calibrating 1P breathing monitors); and U.S. patent no. 4,308,872, issued January 5, 1982
`
`(methods for monitoring respiration volumes).
`
`[0038] Patents disclosing processing of IP signals to obtain measures of cardiac flinction include
`
`(collectively, the “cardiac function patents") U.S. application no. 10/107,078, filed March 26,
`
`2002 (signal processing techniques for extraction of ventricular volume signal); U.S. patent no.
`
`5,588,425, issued Dec. 31, 1996 (methods and systems for discriminating between valid and
`
`artifactual pulse waveforms in pulse oximetry); U.S. patent no. 5,178,151, issued January 12,
`
`1993 (methods for 1? measurement of cardiac output); U.S. patent no. 5,040,540, issued August
`
`20, 1991 (1? measurement of central venous pressure); U.S. patent no. 4,986,277, issued January
`
`22, 1991 (1? measurement of central venous pressure); U.S. patent no. 4,456,015, issued June 26,
`
`1984 (IP measurement of neck volume changes); and U.S. patent no. 4,452,252, issued June 5,
`
`1984 (determining cardiac parameters from neck and mouth volume measurements).
`
`FITBIT, Ex. 1061
`
`

`

`W0 2006!!)09830
`
`PCT/USZGGSHIZ l 433
`
`[0039] Preferably, such lP-based and similar or equivalent physiological sensors are disposed in
`
`unobtrusive, comfortable, and non—restricting fabric structures and wearable items, such as
`
`garments and/or bands, that are worn by a monitored subject. This invention includes a variety
`
`of wearable items and sensor diSpositions therein, the particulars of which depend primarily on
`
`the type and extent ofphysiological monitoring. Wearable items include garments, shirts, vests,
`
`bands, caps, patches, and the like, all with one or more sensors. Associated with a wearable item
`
`is a local processing/storage/communication device unit (LDU) that serves to retrieve sensor data
`
`using wired or wireless link to the sensors carried by the wearable item, to preprocess the sensor
`
`data, and to relay selected data to external monitoring facilities and personnel. An LDA also can
`
`serve to perform assessment of the subject‘s physiological condition, to output data to the
`
`subject, and to receive subject input. Typically, the LDU is carried by a subject separately from
`
`a garment or band, but can also be carried in or on or incorporated into the sensor gannent (e.g_,
`
`in the form ofwearable electronics as known in the art).
`
`applications. Fig. 1A illustrates typical configuration 201 in which a half-shirt, or vest, or
`similar, includes at least two sensor bands 203 (e.g., [1" based), as well as other sensor types,
`
`being, for example, less than approximately 400 g or less.
`
`[0040] Figs. lA-C illustrate several Wearable items preferred for differing monitoring
`
`such as ECG electrodes 205, thennistors, accelerometers, and the like (not illustrated). Sensor
`
`bands 203, if positioned at the rib cage and abdomen, provide at least respiratory rate and
`
`respiratory volume information. If positioned at the mid-thorax, both respiratory and cardiac
`
`data can be provided. Separate LDU 207 provides for output to and input fi-om the subject, and
`
`is connected to sensors by wired link 209. The item can be less than approximately 750 g or
`
`lighter.
`
`[0041] Fig. 18 illustrates a more simple wearable item configured as single 213 band that can
`
`carry multiple sensors, for example, a single lP-based sensor band (or equivalent), ECG
`
`electrodes, as well as other sensor types such as described above. LDU 211 is configured in a
`
`convenient wristwatch-like form and is wirelessly linked to the sensors, for example, by a
`
`Bluetooth-like network or similar. This LDU has more limited capability for subject input and
`
`output. This illustrated configuration can have substantially less weight than that of Fig. 1A,
`
`FITBIT, Ex. 1061
`
`

`

`W0 2006f009 830
`
`PCTI' U 52005102 1433
`
`[0042] Alternatively, LDU 21 l can be configured to be carried in or on or integral to band 213.
`
`A subject can then quickly and easily begin physiological monitoring by simply placing such a
`
`combined band about the torso. Further, such a combined band—LDU can be advantageously
`
`jointly configured to be attached to or to accompany various types of garments so that ordinary
`
`garments not initially contemplated for use in physiological monitoring can be easily equipped
`
`with monitoring capabilities. Attachment can be by Velcro, snaps, zippers, and the like.
`
`Sufficiently elastic bands can also accompany garments withont special attachments. For
`
`example, subjects wearing the usual wet suits, bicycling shirts, football uniforms, and other
`
`athletic clothing can be easily mon