(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY(PCT)
`
`
`
`(19) World Intellectual Property Organization
`International Bureau
`
`(43) International Publication Date
`26 January 2006 (26.01.2006)
`
`(51) International Patent Classification:
`AG6IB 5/00 (2006.01)
`
`(21) International Application Number:
`PCT/US2005/02 1433
`
`(22) International Filing Date:
`
`17 June 2005 (17.06.2005)
`
`(25) Filing Language:
`
`(26) Publication Language:
`
`(30) Priority Data:
`60/580,971
`
`English
`
`English
`
`18 June 2004 (18.06.2004)
`
`US
`
`(71) Applicant (for all designated States except US): VIVO-
`METRICS INC.,, 121 N. Fir Street, Suite E, Ventura, CA
`93001 (US).
`
`(72)
`(75)
`
`Inventors; and
`Inventors/Applicants (for US only): BEHAR, Andrew
`[US/US]; 1105 North Signal Street, Ojai, CA 93023 (US).
`COBB, Jeff [US/US]; 1596 Burnside Drive, Ventura, CA
`93004 (US). DERCHAK,Alex; 9 Beekman Terrace, Sum-
`mit, NJ 07901 (US), KEENAN, Barry; 5185 Kara Drive,
`Santa Barbara, CA 93111 (US). DARNALL, Dave; Ven-
`tura, CA (US).
`
`HOIATA
`
`(10) International Publication Number
`WO 2006/009830 A2
`
`(81) Designated States (unless otherwise indicated, for every
`kind of national protection available): AE, AG, AL, AM,
`AT, AU, AZ, BA, BB, BG, BR, BW, BY, BZ, CA, CH, CN,
`CO, CR, CU, CZ, DE, DK, DM, DZ, EC, EE, EG, ES, FI,
`GB, GD, GE, GH, GM, HR, HU, ID, IL, IN, IS, JP, KE,
`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, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC,
`VN, YU, ZA, ZM, ZW.
`
`(84) Designated States (unless otherwise indicated, for every
`kind ofregional protection available): ARIPO (BW, GH,
`GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, 7M,
`ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM),
`European (AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI,
`FR, GB, GR, HU,IE, 1S, IT, LT, LU, MC, NL, PL, PT, RO,
`SE, SI, SK, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN,
`GQ, GW, ML, MR, NE, SN, TD, TG).
`
`Published:
`
`without international search report and to be republished
`upon receipt of that report
`
`(74)
`
`Agent: RENFREW, Dwight, H.; Ohlandt, Greeley, Rug-
`giero & Perle, LLP, One Landmark Square, 10th Floor,
`Stamford, CT 06901-2982 (US).
`
`For two-letter codes and other abbreviations, refer to the "Guid-
`ance Notes on Codes and Abbreviations" appearing at the begin-
`ning of each regular issue of the PCT Gazette.
`
`(54) Title: SYSTEMS AND METHODS FOR REAL-TIME PHYSIOLOGICAL MONITORING
`
`
`
`
`
`0830A2[IIITIITUNINIIIINITAATEATAUACA
`
`©} (57) Abstract: The present invention provides systems and methods for monitoring in real time the physiological status ofone or
`\6 more subjects, especially subject engaged in potentially hazardousor dangerousactivities. Systemsinclude wearable items with one
`۩ or more physiological sensors and a local data unit (LDU) operatively coupled to the sensors. The LDUs digitize and filter sensor
`©} data, extract physiological parameters, determine abnormal or not acceptable physiological conditions, and communicate to exter-
`nal monitoring facilities. The external facilities display status and data concerning monitored subjects. In preferred embodiments,
`communication between the LDUs and the external monitoring facilities dynamically adjusts to the condition of the subjects and to
`system changes such as subjects and external facilities entering and leaving and/or moving from place to place. The invention also
`provides program products for performing this invention’s methods.
`
`Apple Inc.
`APL1061
`U.S. Patent No. 8,923,941
`
`Apple Inc.
`APL1061
`U.S. Patent No. 8,923,941
`
`I
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`WO 2006/009830
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`PCT/US2005/021433
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`SYSTEMS AND METHODS FOR REAL-TIME PHYSIOLOGICAL MONITORING
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`1.
`
`FIELD OF THE INVENTION
`
`[0001] The present invention provides improved systems and methodsfor 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,orthelike.
`
`2;
`
`BACKGROUNDOF THE INVENTION
`
`[0002] Real-time monitoring and display of physiological data from monitored subjects is now
`of interest in manyfields of endeavor. For example, such monitoring can be useful where the
`monitored subjects are in potentially stressful or hazardoussituations. Such situation occurin
`
`the military, in first responder professions such as firefighters, rescuers, police and thelike,
`
`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 methodsforreal-time physiological monitoring are knowninthepriorart.
`For example, U.S.patent no. 6,198,394 BI (the '394 patent), filed December 5, 1996, discloses a
`
`system for remote monitoring directed to military applications. It describes systemsthat require
`
`subjects to wear a military-type harnessesthat carry a variety of sensors and communication
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`equipment. However, such military-grade equipment designed for battlefield use has limited
`
`appealin other applications.
`
`[0004] Otherprior-art monitoring systems and methods can be more appealing for non-military
`
`use. For :xample, U.S. 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 garmentsof various types and can provide quantitative data on cardiac, respiratory,
`and other physiologic systems. However, such systems havenot been adaptedtoreal-time
`operation in field conditions.
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`[0005] Thus,that prior art lacks monitoring systems that provide 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 overcomingthis lack in the prior art by providing
`
`monitoring systems and methodsthat gather quantitative physiological data in real-time by
`
`means of subject-monitoring technologies that are appealing to a broad range of monitored
`
`subjects.
`
`{9007} 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 (LDU)) for acquiring data from the monitoring apparatus (collectively,
`
`"monitoring apparatus"), Preferably, sensors are arrangedin or carried by a wearable item that
`
`_
`
`can be comfortably 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,
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`for example, by being arranged in (openor closed) pockets, by being attached to a garment, as by
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`sewing, gluing, Velcro, and the like, or by being integral to the garment. In the latter case, the
`
`garmentcan serve asall 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 sensorsif
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`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] Manydifferent types of sensors can be present in different embodimentofthis invention
`that can be inturn directed to different applications. Generally, system sensorsincludeoneor
`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 thelike;
`
`sensors for skin temperatures, sensors for electroencephalographic signals; and so forth. In
`
`certain applications, sensors can also includeballistic impact microphonesfor registering
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`impacts received by a monitored subject that may indicate bodily injury. Sensors can be based
`
`on the various technologies knownin these arts. Preferred sensors for respiratory function are
`
`based on inductive plethysmographic technology that measures respiratory motionsof the
`
`subject thorax and/or abdomen. Preferred sensors for cardiac function are based onelectrical
`
`detection of heart activity, and/or also on plethysmographic technology that measures cardiac or
`
`vascular pulsations. Preferred sensors for posture and activity are based on processing data from
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`one or more accelerometers mechanically coupled to the subject
`
`[0009] LDUsgather, preferably process, and communicate sensor data.
`
`If appropriate sensor
`
`data is gathered, LDUspreferably extract respiration rate, and/orheart rate, and/or body
`
`temperature, and/or posture, and/or indicia of activity, and/or oxygen saturation. LDUs can
`
`extract other or additional physiological parameters that may be appropriate for particular
`
`applications ofthis invention. For example, tidal volume and minute ventilation can be extracted
`
`from plethysmographic respiratory data. Preferably, LDUs also determine and check selected
`conditions indicating physiological distress or danger. Moresimple 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/orcorrelating
`
`combinations of two or more physiological parameters against joint boundsorjoint ranges.
`LDUsalso preferably display, audibly indicate, or otherwise make monitored subjects aware of
`their current physiological status.
`
`[0010] LDUsalso preferably communicate someorall 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 bein the vicinity of, for example from
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`hundredsto thousands of meters from, monitored subjects; or can be remote, for example more
`
`than thousands of meters from, monitored subjects. For example, LDUs maywirelessly
`communicate with local monitoringfacilities that process and display data from communicating
`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
`
`monitoringfacilities. Also, LDUs can directly communicate with remote monitoring facilities
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`by, for example, being in wireless communication with access points having wired linksto 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
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`other system elements also preferably cooperate to store sensor data andits interpretation for
`
`later analysis and/or audit.
`
`[0011] In preferred embodiments, these communicationlinks and communication patterns are
`dynamically established in responseto current locations of LDUs,local monitoring facilities, and
`
`remote monitoringfacilities (collectively, "system elements"). Since in the field locations of
`
`these system elements can change overtime 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 LDUsand sensordata is being conveyed to external monitoring facilities.
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`[0012] In many embodiments communication bandwidth, especially wireless bandwidth,is
`
`limited, and it is therefore preferably that in normal circumstances LDUsnottransmit all sensor
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`data to local or remote monitoring facilities (and similarly for transmission between separate
`
`external monitoring facilities).
`
`In one.preferred embodiment, LDUsperiodically transmit only
`
`’ brief "OK" messagesas long as no danger, warning, or other exceptional conditions id detected.
`
`Alternatively, LDUs can also transmit someorall of the physiological parameters extracted from
`the sensor data.
`In this embodiment,if a danger, warning, or exceptional condition is detected,
`then LDUs beginto transmit increasingly detailed data concerning the cause of the condition (if
`
`it can be determined). For example, the nature and severity of a detected condition can be then
`
`transmitted. For more severe conditions, LDUscan transmit someorall of the original sensor
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`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
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`location localto 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 and/oris acceptable or not; then by presenting one or more of said monitored
`subjects items selected from said physiological information; then by transmitting items selected
`
`from said physiological information from said locations local to said monitored subjects to a
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`location remote from said monitored subjects; and finally by displaying at said remote location
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`someorall ofsaid transmitted physiological concerning said monitored subjects.
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`[0014] Monitored subjects canbe in potential and/or actual physiological stress such as subject
`
`to heatstress, anxiety, panic, dehydration, and disorientation. Subjects' ambulatory activities
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`include daily-living activities, and/or employmentactivities, and/or professionalactivities,
`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
`subject's activity, parameters describing a subject's energy consumption, and parameters
`
`describing a subject's temperature. Physiological state can be determined by comparing
`individual parameters to pre-determined ranges of values, or by combining multiple parameters,
`e.g., by statistical regression functions, and comparing the combined valuesto pre-determined
`
`regions of parameter space. A subject's ventilatory threshold is preferred for establishing
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`acceptable ranges of exertion.
`
`[0016] In order not to overload remote external monitoringfacilities (also referred to as "remote
`
`locations"), transmitted items are preferably selected in dependence on whetherornotsaid
`
`physiological state is acceptable or not and/or is normal or not. For acceptable or normal
`
`subjects, little more than indication of normalcy can be transmitted. For other subjects,
`
`transmitted items can include someorall of said sensor data and/or said physiological
`information. Andin order to allow flexible use of this invention in unpredictable field
`
`conditions, it is preferred than communication betweenits 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 signalclarity 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
`information onall monitored subjects.
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`[0017] Preferred system elements include portable monitoring apparatusfor real-time.
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`monitoring of an ambulatory subject that includes a wearable item comprising one or more
`
`sensors, said sensors providing one or moresignals responsive to the physiology of an
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`ambulatory subject wearing said item; and a portable data unit local to said wearable item
`
`comprising a processing devicethat performsretrieval and processing said sensorsignals in
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`order to determine physiological information comprising indication of whether a physiological
`
`state of said subject is normalor not and/or is acceptable or not; presentation to a wearer items
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`selected from said physiological information; and transmission items selected from said
`
`physiological information fromsaid portable data unit to a location remote fromsaid portable
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`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 operatively coupled to said display and to said
`communicationinterface that establishes communications with one or more portable monitoring
`apparatus,each portable monitoring apparatus monitoring an ambulatory subject and wirelessly
`
`transmitting physiological information concerning said subject, and receives transmitted
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`physiological information concerning one or more monitored subjects; and displays selected
`
`items of received physiological information. Externalfacilities generally communicate both with
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`portable monitoring apparatus and with other externalfacilities. 71. A system for real-time
`
`monitoring of ambulatory subjects comprising:
`
`[0019] A system ofthis invention includes these elements cooperatively communicating. for real-
`time monitoring of ambulatory subjects, namely one or more portable monitoring apparatus; and
`
`one or more external monitoringfacilities so that said portable monitoring apparatus wirelessly
`
`communicate with at least one of said external monitoring facilities, and wherein at least one
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`external monitoring facility wirelessly communicates with at least one other external monitoring
`
`facility, and wherein said wireless communication comprises physiological information
`
`describing ambulatory subjects monitored by said portable monitoring apparatus.
`
`[0020] The invention also includes program products with computer readable media containing
`computer instructionsfor performing the invention's methods.
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`[0021] A numberofreferences 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. Further, none of these references, regardless of how characterized above,is
`
`admitted as prior to the invention of the subject matter claimed herein.
`
`[0022] Specific embodimentsof this inventionwill be appreciated from the following detailed
`
`descriptions and attached figures, and various ofthe described embodimentsarerecited in
`
`appended claims.
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`4,
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`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[0023] The present invention may be understood morefully by reference to the following
`detailed description of preferred embodiments ofthe presentinvention,illustrative examples of
`specific embodiments of the invention, and the appendedfigures in which:
`
`[0024] Figs. 1A-C illustrates wearable items with sensors;
`
`[0025] Figs. 2A-B illustrate embodiments ofreal-time monitoring systems;
`
`[0026] Figs. 3A-Fillustrate alternative displays of monitored sensordata;
`
`[0027] Figs 4A-Billustrate processing at the monitored subject; and
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`[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").
`
`5
`DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
`[0031] Preferred embodiments of the systems and methodsofthis invention are described in the
`following.
`In the following, and in the application as a whole, headings are used for clarity and
`
`convenience only.
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`5.2.
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`SYSTEM COMPONENTS
`
`[0032] System componentsof the present invention include: monitoring apparatus with
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`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 components.
`
`Preferred embodiments of these components are described in this subsection.
`
`WEARABLE SENSORS AND GARMENTS
`
`[0033] Monitoring apparatus preferably comprises a wearable item or items, such as a garment,
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`shirt, vest, chest strap, patch, cap, or the like, in or on which physiological sensors are disposed.
`
`Appropriate sensor technologies 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 providingreliable, real-time
`_ physiological monitoring data. Weight is an important aspect of comfort, andit is preferred that
`the monitoring apparatus and anyassociated electronics (e.g., LDUs) be less thanabout 800 g,
`
`morepreferably less than 700 g, and even morepreferably less than 600 g or 500 g orlighter.
`
`[0034] One preferred respiratory and/or cardiac sensor technologyis inductive plethysmography
`
`(IP), which has beenclinically confirmed to provide reliable, quantitative data onatleast
`respiratory and cardiac functions.
`IP sensors can be disposed on monitored subjects in various
`kinds of garments, for example, in bands, orin partial-shirts, or in shirts, or on partial bodysuits,
`
`.
`
`or in full body suits, or in caps, and the like. IP-based sensors function by measuring time-
`
`varying inductance of conductive loops (often configured in elastic, expandable bands) that are
`
`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
`enclosed by these loops, and using signal processing and pattern recognition techniques with
`
`reference to established physiological models (such as a two-compartment model of respiratory
`
`volumes), these indicia of cross-section areas can be processedto yield indicia or measures of
`
`physiological functions and/or times of occurrences of physiological events. For example,it is
`
`possible to obtain indicia of cardiac stroke volumes,indicia of respiratory tidal volume and
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`minute ventilation, occurrence times ofrespiratory events, such as apneas,andthelike, and so
`
`forth.
`
`[0035] However, IP-based sensors are preferred and notlimiting, and this invention can readily
`employ sensor based onalternative technologies. Certain alternative sensor technologies make,
`
`similar to [P-based sensors, make measurements reflecting cross-sectionalareas, or
`
`circumferences, or their geometric equivalents, or measurement that can be converted into such
`
`information (for example,stress or strain of an expandable loop about the subject), at one or
`
`more levels through the thorax, abdomen,or other bodystructures, and at sample rates up to 200
`
`Hz. Data from IP and alternative sensors can then be processed by the methodsthat have been
`
`developed for IP signals. For example, alternative sensors can be based on thread and fabric
`
`technologies being and to be developed: a sensor may measurethe resistance of conductive
`
`threads having strain-dependentresistance that are incorporated into garments or bands; or a
`
`sensor may optically or electrically meansthe local stress of a fabric wovenso that local stress
`
`reflects length and/or circumferential. For another example, alternative sensors may use energy
`
`radiation (such as ultrasound radiation, orelectric fields, magnetic fields, or electromagnetic
`
`radiation) to measure geometric parameters (such as distances) through bodystructures.
`
`[0036]. However, for brevity and concreteness only, the subsequent description will be largely in
`
`terms of preferred IP sensor technologies and of processing methodssensitive to body cross
`
`sectional area (or circumference, or the equivalent). Details of the preferred IP technology, its
`
`disposition in garments, its processing andinterpretation, and certain closely allied sensor
`
`technologies is described from the following U.S. patents (collectively, the "IP patents"), all of
`
`whichare incorporated by referencein the entireties herein for all purposes and are assigned to
`
`the assignee ofthis application. Patents disclosing IP technology andits 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 IP 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 IP system including a sensor garment); U.S.
`
`patentno. 5,331,968, issued July 26, 1994 (IP sensors andcircuitry); U.S. patent no. 5,301,678,
`
`issued April 12, 1994 (stretchable IP transducer); and U.S. patent no. 4,807,640, issued February
`28, 1989 (stretchable IP 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 etal.; titled "Systems and Methods for Object-based Monitoring Physiological
`
`Parameters"; current attorney docket no. 10684-035-999), filed June 6, 2004 (improved methods
`for processing respiratory IP signals and for detecting respiratory events from processedsignals);
`U.S. application no. 10/457,097, filed June 6, 2004 (object oriented methods for monitoring of
`
`physiological parameters); U.S. patent no. 6,413,225, issued July 2, 2002 (improved methods for
`
`calibrating IP breathing monitors); U.S. patent no. 6,015,388, issued Jan. 18, 2000 (methods for
`measuring respiratory drive providing various outputs, including control signals for mechanical
`ventilators or continuouspositive air pressure (CPAP) devices); U.S. patent no. 5,159,935, issued
`November3, 1992 (measurements ofindividual lung functions); U.S. patent no. 4,860,766,
`issued Aug. 29, 1989 (noninvasive methods for measuring and monitoring intrapleural pressure
`in newbornsbysurface IP of cranial bones); U.S. patent no. 4,834,109, issued May 30, 1989
`(methods for calibrating IP 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 excursionsofthe rib cage and the abdominal); U.S. patent
`no. 4,648,407, issued Mar. 10, 1987 (methodsfor detecting and differentiating central and
`obstructive apneas in newborns); U.S. patent no. 4,373,534, issued February 15, 1983 (methods
`
`for calibrating IP 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 function include
`
`(collectively, the "cardiac function patents") U.S. application no. 10/107,078,filed March 26,
`
`2002 (signal processing techniquesfor extraction of ventricular volumesignal); U.S. patent no.
`
`5,588,425, issued Dec. 31, 1996 (methods and systems for discriminating between valid and
`
`artifactual pulse waveformsin pulse oximetry); U.S. patent no. 5,178,151, issued January 12,
`
`1993 (methods for IP measurementofcardiac output); U.S. patent no. 5,040,540, issued August
`
`20, 1991 (IP measurementof central venous pressure); U.S. patent no. 4,986,277, issued January
`
`22, 1991 (IP measurementofcentral venouspressure); U.S. patent no. 4,456,015, issued June 26,
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`1984 (IP measurement of neck volume changes); and U.S. patent no. 4,452,252, issued June 5,
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`1984 (determining cardiac parameters from neck and mouth volume measurements).
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`WO 2006/009830
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`PCT/US2003/021433
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`(0039] Preferably, such IP-based and similar or equivalent physiological sensors are disposed in
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`unobtrusive, comfortable, and non-restricting fabric structures and wearable items, such as
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`garments and/orbands, 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
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`the type and extent of physiological monitoring. Wearable items include garments,shirts, vests,
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`bands, caps, patches, andthe like, all with one or more sensors. Associated with a wearable item
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`is a local processing/storage/communication device unit (LDU)that serves to retrieve sensor data
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`using wired or wireless link to the sensors carried by the wearable item, to preprocess the sensor
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`data, and to relay selected data to external monitoring facilities and personnel. An LDAalso can
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`serve to perform assessmentofthe subject's physiological condition, to output data to the
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`subject, and to receive subject input. Typically, the LDUis carried by a subject separately from
`a garmentor band, but can also be carried in or on or incorporated into the sensor garment(e.g.,
`in the form of wearable electronics as known intheart).
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`[0040] Figs. 1A-C illustrate several wearable items preferred for differing monitoring
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`applications, Fig. 1A illustrates typical configuration 201 in which a half-shirt, or vest, or
`similar, includesat least two sensor bands 203 (e.g., IP based), as well as other sensor types,
`such as ECGelectrodes 205, thermistors, accelerometers, and the like (not illustrated). Sensor
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`bands 203, if positioned at the rib cage and abdomen,provideatleast respiratory rate and
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`respiratory volume information. If positioned at the mid-thorax, both respiratory and cardiac
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`data can be provided. Separate LDU 207 provides for output to and input from the subject, and
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`is connected to sensors by wired link 209. The item can be less than approximately 750 g or
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`lighter.
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`[0041] Fig. 1B illustrates a more simple wearable item configured as single 213 band that can
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`carry multiple sensors, for example, a single IP-based sensor band (or equivalent), ECG
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`electrodes, as well as other sensor types such as described above. LDU 211 is configured in a
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`convenient wristwatch-like form andis wirelessly linked to the sensors, for example, by a
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`Bluetooth-like network or similar. This LDU has more limited capability for subject input and
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`output. This illustrated configuration can have substantially less weight than that of Fig. 1A,
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`being, for example, less than approximately 400 g orless.
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`wf pve
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`WO 2006/009830
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`PCT/US2005/021433
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`(0042] Alternatively, LDU 211 can be configured to be carried in or on orintegral to band 213.
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`A subject can then quickly and easily begin physiological monitoring by simply placing such a
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`combined band aboutthe torso. Further, such a combined band-LDUcan be advantageously
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`jointly configured to be attached to or to accompany various types of garments so that ordinary
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`garments not initially contemplated for use in physiological monitoring can be easily equipped
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`with monitoring capabilities. Attachment can be by Velcro, snaps, zippers, and thelike.
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`Sufficiently elastic bands can also accompany garments without special attachments. For
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`example, subjects wearing the usual wet suits, bicycling shirts, football uniforms, and other
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`athletic clothing can be easily monitored; similarly subjects in first responder services, public
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`protective services, military services, and the like can be physiologically monitored without
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`modification to their standard apparel. For more extensive physiological monitoring, ordinary
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`garments can be accompaniedbyorattached to two or more sensor-LDU combinations. For
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`example, a second band about a subject's torso can provide more accurate respiratory monitoring
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`as well as carry additional physiological sensors of other types. This invention also includeskits
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`of two or more such sensor-LDU combinations. Different combinations can multiply monitor
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`single physiologica