US005778882A
`5,778,882
`(11) Patent Number:
`United States Patent
`Jul. 14, 1998
`(45) Date of Patent:
`Raymondet al.
`
`
`(54) HEALTH MONITORING SYSTEM
`[75}
`Inventors: Stephen A. Raymond, Charlestown;
`;
`*
`Geoffrey E. Gordon, Boston; Daniel B.
`Singer, Weymouth. all of Mass.
`.
`.
`;
`[73] Assignee: Brigham and Women’s Hospital,
`Boston, Mass.
`
`[56]
`
`[21] Appl. No.: 394,157
`(22] Filed:
`Feb. 24, 1995
`é
`[51] Ent. Cho oececcscceccenstecnsseneunenescesessecenes AG6IB 5/0402
`
`.. 128/700; 128/710
`[52]
`
`[58] Field of Searchy ou...ccccsseseceecseeeene 128/696, 710.
`128/700; 364/413.06, 413.03
`References Cited
`U.S. PATENT DOCUMENTS
`;
`D. 247,258
`«2/1978 Napoli...scssssesseeseecseneees D24/17
`
`4,262,632
`-...esseeeereseseereneenes 119/1
`4/1981 Hantonet al.
`4,353,375 10/1982 Colburn Ct al. occeesercecesereenes 128/782
`4,367,752
`1/1983 Jimenez et al. .
`teener oiloge Schroeeel sesaaescunseavsaeeteneaenanees eee,
`.
`°° oeA8
`*41;
`ston6 wn
`etal.
`
`BEBMDAD sesresseseeerecnserecereereeeneece
`522,
`.. 364/415
`4,686,624
`8/1987 Blum etal.
`4303625
`2/1989 Fuet al
`364/413
`
`7/1989 Lesho etal...
`4844076
`128/736
`
`11/1989 Bemard etal...
`. 128/670
`4,883,063
`.seesecrsacsnsesnsnen 128/721
`4,909,260
`3/1990 Salem et al.
`4,966,154 10/1990 Cooperetal. .
`....csssssssssssssseesses 123/696
`4,974,601
`12/1990 Tranjan et al.
`4,987,897
`1/1991 Funke ......ssssss
`... 128/419
`5,002,064
`3/1991 Allain etal. ...
`.. 128/710
`5,063,937
`11/1991 Ezenwaetal. ...
`128/723
`1/1992 Heilman etal. ..
`- 128/421
`5,078,134
`
`.....
`5,111,818
`5/1992 Suzuki et al.
`128/644
`3,113,859
`5/1992 Funke .........
`128/419
`
`7/1992 Fangetal.........
`5,128,552
`307/66
`7/1992 Sakaguchi etal.
`5,131,390
`128/632
`
`...
`5,137,345
`8/1992 Waldorf et al.
`351/206
`yhoo: Bie sereennensene
`aaRe
`128/704
`Comdan ower
`~- 128/782
`197489
`31993
`
`4/1993 Zimmerman etal. ......0...... 128/670
`5,199,439
`
`FOREIGN PATENT DOCUMENTS
`0299667
`1/1989 European Pat.Off..
`2686497
`96/1991
`‘France .
`8802237
`4/1988 WIPO
`3905116
`6/1989 WIPO.
`9401040
`1/1994 WIPO.
`9413198
`6/1994 WIPO.
`9424929 11/1994 WIPO.
`
`OTHER PUBLICATIONS
`G. Wiesspeiner, W Xu, Multichannel Ambulatory Monitor-
`ing of Circulation Related Biosignals, Institute of Biomedi-
`cal Engineering. pp. 457-460, 1992.
`
`Primary Examiner—Scott M. Getzow
`Attomey, Agent, or Firm—Kudirka & Jobse. LLP
`[57]
`ABSTRACT
`A health monitoring system whichtracks the state of health
`of a patient and compiles a chronological health history of
`the patient uses a multiparametric monitor which periodi-
`cally and automatically measures and records a plurality of
`physiological data from sensors in contact with the patient’s
`body. The data collected is not specifically related to a
`particular medical condition but, instead, provides the infor-
`mation necessary to derive patterns which are characteristic
`of healthy patients as well as those whoareill. The data
`:
`gs
`. 4
`collected is periodically uploaded to a database in which it
`is stored along with similar health histories for other
`Patients. The monitoris preferably self-contained in a chest
`_‘Sttap whichis located onthe patient’s torso. and makesuse
`of a controller which controls sampling of the desired data
`and storage of the data to a local memory device pending
`uploading to the database. The more voluminousdata col-
`lected is reduced and compressedprior to storage in the local
`memory device. Preferably. much of the monitor circuitry is
`run intermittently to conserve power. The monitor data is
`supplemented with subjective data (such as psychological
`and environmental conditions) collected from the patient
`using a handheld data input device which runs a program to
`solicit information from the patient. The subjective data
`collected is chronologically aligned with the monitor data in
`the database such that the health history of a patient includes
`both objective and subjective medical data.
`
`(List continued on next page.)
`
`17 Claims, 27 Drawing Sheets
`
`PAIN: LOCATION OF PAIN
`
`‘
`CISELECT AN AREA THAT HURTS
`
`10
`
`INTENSITY)OF PAIN AT THIS SITE NOW
`MAX
`NONE i
`0
`
`\ 208
`
`APPLE 1009
`
`APPLE 1009
`
`1
`
`

`

`5,778,882
`
`Page 2
`
`U.S. PATENT DOCUMENTS
`
`5,213,106
`5,213,555
`5,218,969
`5,222,503
`5,226,424
`§,226,539
`5,228,450
`
`5/1993 Lerner...ssssesssscersserreeseecsenses 128/696
`5/1993 Hood et al.
`....
`weve 482/57
`
`6/1993 Bredesen et al.
`. 128/710
`. 128/731
`6/1993 Ives et al.
`
`a. 128/696
`7/1993 Bible .......
`
`we 206/534
`7/1993 Cheng .
`
`7/1993 Sellers ..csccsscssssarerssenceansseene 128/711
`
`5,253,654 10/1993 Thomaset al.
`......ssscsseccrseneee 128/779
`
`5,261,441
`11/1993 Butterfield et al.
`.
`. 128/672
`5,271,405 12/1993 Boyeretal. .....
`128/672
`
`5,275,159
`1/1994 Griebel .....
`128/633
`
`-. 364/413
`5,280,429
`1/1994 Withers ....
`
`..
`.. 128/696
`5,289,824
`3/1994 Milss et al.
`4/1994 Brown..........
`. 364/413.09
`5,307,263
`
`....csccesccssenenneeee 128/700
`5,447,164
`9/1995 Shaya et al.
`5,454,376 10/1995 Stephens et al...eesernee 128/644
`
`2
`
`

`

`U.S. Patent
`
`
`
`sqvooayWoidsaW
`
`TWHLN39
`
`Jul. 14, 1998
`
`Sheet 1 of 27
`
`ooo;Joon,|!golcstt801
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`5,778,882
`
`
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`Launodlaoot
`
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`
`3
`
`
`
`

`

`U.S. Patent
`
`Jul. 14, 1998
`
`Sheet 2 of 27
`
`5,778,882
`
`ezp--52SH//4QE’PEL||evl
`tpt.ZELwae/*;44“\
`-_@¢#.¢@©©©@eee©CAOOOYSeeeeeee\1V@
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`
`¢JuNDIS
`
`4
`
`
`

`

`U.S. Patent
`
`Jul. 14, 1998
`
`Sheet 3 of 27
`
`5,778,882
`
`EKG
`ELECTRODES
`
`140
`
`
`
`CHEST
`EXPANSION
`SENSOR
`
`132
`
`ACCELERO -
`METER
`
`(A)
`
`134
`
`
`
`MICROPHONE
`
`(M)
`
`BARO-|439
`138
`METRIC
`MONITOR
`PRESSURE
`HARDWARE
`SENSOR
`(B)
`
`144
`
`
`
`142
`
`UNDER ARM
`TEMP
`SENSOR
`(Ty)
`
`128
`
`PECTORAL
`
`AMBIENT
`TEMP
`SENSOR
`
`(T,)
`
`FIGURE3
`
`5
`
`

`

`
`ceeSy$1uOdO/|IVLIDIG
`it|i1ft|||||baunNdIA||||J|||6gh-~|is,--4|folfot
`prtPSIaorviva°
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`postparoRE|(auois|I|(3UOLS||WyHD0ud)—||wyuooud)—nda||woud||wouda
`HaTIOULNODSINyM_Ag
`zst|wwe|1styf9st
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`Loorftehh,Anam
`root4PTNe
`Lo.—_—H4L_--~_—_
`
`HATIOULNOOLread
`
`
`
`
`
`U.S. Patent
`
`Jul. 14, 1998
`
`Sheet 4 of 27
`
`5,778,882
`
`2be
`
`
`
`p9lSDGATIMONNOV
`
`
`
`1aSaYyYOLVYDSALNIOL
`
`zyhSpi’
`
`(AMLINDYIODOTIVNYOL) SHOSN3S
`
`6
`
`
`
`
`

`

`U.S. Patent
`
`Jul. 14, 1998
`
`Sheet 5 of 27
`
`5,778,882
`
`GROUP
`
`BODY MONITOR SERVICE GROUPS
`
`EKG- Sample and Process
`
`100 Hz|Ventilation - Sample and Process
`Acceleration - AC Sample and Process
`
`Reset Minute Packet Accumulators
`
`EKG- Pending Packet Transmission
`
`Breath Sound Integral - Sample and Process
`Voice Sound Integral - Sample and Process
`Acceleration - AC Integral Process
`Acceleration - DC Integral Process
`
`Record Barometer
`Record Pectoralis Temperature
`Record Underarm Surface Temperature
`Record Ambient Temperature
`Transfer Minute Packet to Memory
`
`FIGURE 6
`
`SCRATCHPAD
`
`WAREHOUSE
`
`
`
`EKG - sid ZONE
`
`
`
`168
`
`170
`
`172
`
`FIGURE5
`
`7
`
`

`

`U.S. Patent
`
`Jul. 14, 1998
`
`Sheet 6 of 27
`
`5,778,882
`
`MINUTE
`
`foTofojfofojofoj1
`
`+31 BYTES
`
`EKG-ts
`
`fofofrrix]x]x]x|
`
`+ 2BYTES
`
`EKG - lid
`
`EURESEIESESES
`
`+ 1BYTE
`
`VENT- i
`
`+ 2BYTES
`
`EKG- sid
`
`[XTX[XTX[XXTX]
`
`FIGURE 7
`
`8
`
`

`

`U.S. Patent
`
`Jul. 14, 1998
`
`Sheet 7 of 27
`
`5,778,882
`
`SNINSVE
`
`00¢
`
`OOL
`
`
`
`(sw)SWIL
`
`8JYNIIA
`
`WNWINIW
`
`WNWIXVW
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`
`aquvnd
`
`aONvad
`
`00c!
`
`O0OO0L
`
`00F
`
`AMPLITUDE
`
`002
`
`9
`
`

`

`U.S. Patent
`
`Jul. 14, 1998
`
`Sheet 8 of 27
`
`POWER
`
`900
`
`INITIALIZE
`HARDWARE/
`
`VARIABLES
`
`902
`
`ENABLE
`INTERRUPTS
`
`potctcccccccn
`
`
`
`CHECK
`TASK
`REGISTER
`
`304
`
`906
`
`908
`
`CALL HIGHEST
`PRIORITY TASK
`
`
`Y
`
`
`
`
`
`
`TIMER
`
`INTERRUPT
`SLEEP (__)
`
`RETURN FROM
`INTERRUPT AFTER
`
`SLEEP
`
`FIGURE9
`
`10
`
`10
`
`

`

`U.S. Patent
`
`Jul. 14, 1998
`
`Sheet 9 of 27
`
`5,778,882
`
`10.1
`
`1000
`
`1002
`
`1004
`
`1006
`
`1008
`
`1010
`
`1012
`
`SAVE
`CONTEXT
`
`SAMPLE EKG
`CHANNEL
`
`CALL EKG
`ROUTINE
`
`
`
`UPDATE
`MASTER CLOCK
`
`UPDATE
`SCHEDULING
`VARIABLES
`
`SAMPLE
`TASK GROUP
`CHANNELS
`
`
`
`RESTORE
`CONTEXT
`
`FIGURE 10
`
`11
`
`11
`
`

`

`U.S. Patent
`
`Jul. 14, 1998
`
`Sheet 10 of 27
`
`5,778,882
`
`11.4
`
`TRACK BASELINE
`
`1100
`
`
`
`
`BASELINE +
`
`KaeNN
`
`1102
`
`1104
`
`4106
`
`BEGIN
`S COUNT A
`
`1109
`
`4107
`
`STORE
`TIMESTAMP
`
`SAMPLE COUNT ;1105
`1108|
`SAMPLE COUNT
`
`INCREMENT
`
`P. 43
`
`1110
`
`INCREMENT
`
`END AND STORE
`4112 ~~|SCOUNTA
`
`1113
`
`ul
`
`70
`
`m”
`
`“
`
`FIGURE 11A
`
`12
`
`12
`
`

`

`U.S. Patent
`
`Jul. 14, 1998
`
`Sheet 11 of 27
`
`5,778,882
`
`1114
`
`1115
`
`1120
`
`1116
`
`1117
`
`1118
`
`FIGURE 11B
`
`13
`
`13
`
`

`

`U.S. Patent
`
`Jul. 14, 1998
`
`Sheet 12 of 27
`
`5,778,882
`
`1124
`
`INCREMENT
`SCOUNT B
`
`11.2
`
`1122
`
`1126
`
`Y
`
`END AND STORE
`SCOUNTB
`
`4127 a> N
`
`1128
`
`4129
`
`1130
`
`N
`
`Y
`
`P=s
`
`
`
`41.3
`
`FIGURE 11C
`
`14
`
`14
`
`

`

`U.S. Patent
`
`Jul. 14, 1998
`
`Sheet 13 of 27
`
`5,778,882
`
`1132
`
`1134
`
`1136
`
`1138
`
`1140
`
`BL
`
`START
`SCOUNT C
`
`co
`
`STORE
`SCOUNT C
`
`1137
`
`INCREMENT
`
`SAMPLE COUNT
`
`
`
` S>
`
`
`
`BASELINE
`< GUARD?
`
`1142
`
`
`
`COMPUTE NEW
`FEATURE POINTS-
`QUEUE EKG
`PACKET TO
`TRANSMIT
`
`FIGURE 11D
`
`15
`
`15
`
`

`

`US. Patent
`
`Jul. 14, 1998
`
`Sheet 14 of 27
`
`5,778,882
`
`1200
`
`RISING
`
`VENTILATION \PLATEAU
`TASK
`
`FALLING
`
`1202
`
`DO PLATEAU
`DETECTION
`
`DO PLATEAU
`DETECTION
`
`1204
`
`
`STATE =
`STATE =
`
`
`RISING/
`FALLING/
`
`
`RECORD
`RECORD
`
`
`TIMESTAMP
`TIMESTAMP
`
`
`
`
`
`
`
`
`
`TRANSMIT
`TRANSMIT
`
`
`INFLECTION
`INFLECTION
`PACKET
`
`PACKET
`
`Y
`
`
`mY
`FIGURE12A.
`
`Y.
`
`16
`
`16
`
`

`

`U.S. Patent
`
`Jul. 14, 1998
`
`Sheet 15 of 27
`
`5,778,882
`
`12.1
`
`1228
`
`STATE =
`1224
`Y.|RISING/RECORD
`TIMESTAMP
`
`1230
`
`DONEBem
`
` 1236
`
`1226 \
`
`Y
`
`STATE =
`FALLING/
`RECORD
`TIMESTAMP
`
`TRANSMIT
`INFLECTION
`PACKET
`
`RESET P COUNT
`
`1232
`
`1234
`
`FIGURE 12B
`
`17
`
`17
`
`

`

`U.S. Patent
`
`Jul. 14, 1998
`
`Sheet 16 of 27
`
`5,778,882
`
`PLATEAU
`DETECTION
`
`1300 <> Y
`
`N
`
`P COUNT=
`P COUNT+1
`
`1302
`
`41304
`
`1306
`
`1310
`
`P COUNT = 0
`
`RETURN
`
`Y
`
`RECORD
`TIMESTAMP
`
`RETURN
`
`1303
`
`1305
`
`1308
`
`1312
`
`1314
`
`Y
`
`
`
`TRANSMIT
`PLATEAU
`PACKET
`
`STATE
`= PLATEAU
`
`RETURN
`
`FIGURE 13
`
`18
`
`18
`
`

`

`U.S. Patent
`
`Jul. 14, 1998
`
`Sheet 17 of 27
`
`5,778,882
`
`POWER
`
`INITIALIZE
`
`1400
`
`OAeres.
`
`RETURN FROM
`
`INTERRUPT AFTER
`SLEEP
`— eo “”|
`
`
`
`N
`
`1
`
`fo
`SLEEP
`
`NEW DATA
`
`1404
`
`1406
`
`1408
`
`1410
`
`DATA
`PRESENT?
`
`INTERRUPT. |
`
`
`
`
`POST-PROCESS
`PACKET
`-———'}_ SAVE CONTEXT
`
`
`
`
`
`SET ADDRESS
`LINES AND
`
`
`STORE PACKET
`
`
`
`STORE
`INCOMING
`PACKET
`
`RESTORE
`CONTEXT
`
`RETURN FROM
`INTERRUPT
`
`FIGURE 14
`
`19
`
`19
`
`

`

`U.S. Patent
`
`Jul. 14, 1998
`
`Sheet 18 of 27
`
`5,778,882
`
`202
`
`106
`
`FIGURE 15
`
`20
`
`20
`
`

`

`U.S. Patent
`
`Jul. 14, 1998
`
`Sheet 19 of 27
`
`5,778,882
`
`VOLAYNDIA(CaNoe
`jalsNovaa=on
`‘NiVd
`MON3LISSIHLLVNidJO(ALISNSLNI
`NIVdJONOILV9O1
`————
`
`SLYNHLVHLV3YVNVLOATSS(4
`
`9LFUNDA
`
`21
`
`21
`
`
`

`

`U.S. Patent
`
`Jul. 14, 1998
`
`Sheet 20 of 27
`
`5,778,882
`
`PAIN: LOCATION OF PAIN
`
`SELECT AN AREA THAT HURTS
`
`205
`
`208
`
`[|
`
`NEXT
`
`INTENSITY}OF PAIN AT THIS SITE NOW
`
`NONE
`
`0
`
`MAX
`
`10
`
`206
`
`210
`
`FIGURE 16B
`
`22
`
`22
`
`

`

`US. Patent
`
`Jul. 14, 1998
`
`Sheet 21 of 27
`
`5,778,882
`
`: HISTORY OF PAIN AT THIS SITE
`
`oh,
`
`SSflliiHT
`
`PAININTENSITY
`
`8
`89101112123 45 6 7
`NOON
`TIME (HOURS)
`
`9 101112
`MIDNIGHT
`
`
`
`
`
`
`
`peo eit|peoooAM 12:eit|
`
`ANOTHER PAIN SITE?
`
`216
`
`218
`
`FIGURE 17
`
`23
`
`23
`
`

`

`U.S. Patent
`
`Jul. 14, 1998
`
`Sheet 22 of 27
`
`5,778,882
`
`PERSONAL REPORT: MOOD (NOW)
`
`220
`
`NONE
`
`WORST
`
`DEPRESSION
`
`ia|
`
`NONE
`
`. WORST
`
`NONE
`
`WORST
`
`IRRITABILITY |
`
`NEXT
`
`FIGURE 18
`
`24
`
`24
`
`

`

`U.S. Patent
`
`Jul. 14, 1998
`
`Sheet 23 of 27
`
`5,778,882
`
`MEDICATIONS
`
`SELECT ONE DRUG AT A TIME AND TOUCH THE
`"DOSE ENTRY" ZONE AT THE TIME YOU TOOK IT.
`TOUCH AGAIN FOR MULTIPLES.
`
`221
`
`OROMORPWA NAPROXEN©ASPIRIN apencosey{7 OTHERS
`
`12:01 AM
`
`224
`
`224
`
`“. \\\XKCGQ
`
`||
`
`Ald NG
`AIG41 pose
`pose HIMES
`
`em sucem ENTRYfuer
`
`89101112123 45 6 7
`NOON
`
`8
`
`9 101112
`MIDNIGHT
`
`NOW
`09/01/94
`
`DOSE TIME
`
`FIGURE 19
`
`25
`
`25
`
`

`

`U.S. Patent
`
`Jul. 14, 1998
`
`Sheet 24 of 27
`
`5,778,882
`
`PERSONAL REPORT: SIDE EFFECTS
`(OCCURRING SINCE LAST REPORT)
`
`228
`
`NONE
`
`WORST
`
`Gi vrowsiness|(_{}-——
`(fj DIZZINESS ——-——
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`FIGURE 19A
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`US. Patent
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`Jul. 14, 1998
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`Sheet 25 of 27
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`5,778,882
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` 3. MESSAGES: FROM <USER>
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`© IF YOU WISH, YOU MAY WRITE A
`NOTE TO THE STUDY MANAGER
`IN THE SPACE BELOW:
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`MESSAGE FROM <USER>:
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`250
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`PLEASE INITIAL YOUR REPORT BELOW:
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`256+57] PLEASE HAVE THE STUDY
`MANAGER CALL ME:
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`839%
`V7 UNDO FIND ASSIST
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`FIGURE 20A
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`US. Patent
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`Jul. 14, 1998
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`Sheet 26 of 27
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`5,778,882
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`[3(] MESSAGE:To <USER>
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`MESSAGE FROM THE STUDY MANAGER:
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`THANK YOU <USER>, FOR ANOTHER
`REPORT.
`DO YOU HAVE ENOUGH TYLENOL
`FOR THIS WEEK?
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`U.S. Patent
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`Jul. 14, 1998
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`Sheet 27 of 27
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`5,778,882
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`FIGURE 21
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`5.778.882
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`1
`HEALTH MONITORING SYSTEM
`
`BACKGROUND OF THE INVENTION
`
`1. Field of the Invention
`The present invention relates to the field of medicine and
`health and, more specifically, to health tracking including
`assessing trendsin health and the diagnosing and monitoring
`of medical conditions.
`
`2. Description of the Related Art
`the advent of high
`In the medical profession today.
`technology has provided a myriad of impressive diagnostic
`tools. However the focus of this medical technology has
`been on diagnosis of acute conditions, rather than advanced
`warnings and preventive advice. Routine “checkups”are the
`recognized method of monitoring a person’s health. Such
`examinations provide a physician with informationrelating
`to the patient's condition. However, unless a patient's
`checkup is fortuitously scheduled for a time at which
`symptoms of an ensuing illness are just developing, the
`checkup maynotbe effective in helping to detect the onset
`of an adverse medical condition.
`
`Portable health monitors have been developed in the past
`which monitor body parameters specific to a particular
`medical condition. In some cases these monitors record
`specific parameter data, while in others they provide an
`output to the patient which is indicative of the physical
`parameters they sense. Some monitors simply provide an
`alarm whenthe parameters reach a pre-set level of particular
`concern. Others, specifically some portable heart rate
`monitors, provide a digital display of heart rate to the
`patient. Still others record heart rate over time. Patients use
`such heart rate monitors to warn them of high heart rates.
`Athletes use them to ensure that their physical training
`includes periods of elevated heart rate thought to be suffi-
`cient to promote conditioning. Similar monitors also exist
`for measuring other parameters. usually individually or
`without the capability to store the information for extended
`periods of time.
`
`SUMMARY OF THE INVENTION
`
`Absent from the prior art is a portable monitor having the
`capability to construct, manage, and store a detailed, multi-
`parametric, record of an individual’s physiological and
`emotional well-being that can be used for tracking and
`assessing general health over days, months, and years. The
`present invention comprises a health monitoring system
`including a database and data management system linked
`with a plurality of health trackers, each of which regularly
`collects various forms of data about or from a patient/
`subject. The preferred embodimentof the invention consists
`of three basic components: 1) a data management system
`including the database; 2) a plurality of physiological and
`subjective data collection devices that collect a set of
`timestampedserial streams from a subject; and 3) a com-
`munications system by which the data is periodically
`uploaded from the monitors to the database.
`In the preferred embodiment the health trackers each have
`a portable multiparametric monitor that automatically and
`noninvasively monitors physiological parameters. The
`health trackers each preferably also include a data logger
`that permits and/or prompts the patient to enter subjective
`reports of psychological and physiological data. as well as
`activities and environmental conditions. Thus. a composite
`stream (preferably serial) of objective physiological and
`subjective data is created which is indicative of the overall
`health history of a patient/subject.
`
`2
`In order to be effective as a prospective diagnostic tool.
`the information collected is not anticipatory of any specific
`medical condition, but is instead broadly related to the
`general health of the patient. That is, the data is collected
`from numerous health indicators or metrics, each of which
`may have somerelationship, or may be completely unrelated
`to. any particular medical condition. The composite multi-
`parametric data streams in combination provide enough
`information to allow the identification of a wide variety of
`possible trends in the tracking data which, as an ensemble,
`maybe indicative of any of a variety of medical conditions.
`Although the data collected is not specifically related to
`tracking any particular condition,
`the entire system is
`designed so that patterns which are characteristic of healthy
`subjects. as well as ill ones, can be derived from the
`collected data.
`The preferred embodiment of the data collection portion
`of the invention collects a combination of sensed physi-
`ological data and subjective data entered by the patient. For
`subjective data collection. the patient-supplied data is solic-
`ited by the data logger using data prompts, which may be in
`the form of health-related questions. These questions may
`include interactive input formats such as body diagrams or
`the like. As the data is collected,
`it
`is time stamped,
`compressed (where appropriate) and uploaded to the
`database, labeled for the patient in question. The resulting
`health history is a combined format of objective physical
`parameters and subjective patient data which is time-
`indexed for subsequent retrieval and analysis. From these
`stored datastreams, trends in the data may be identified.
`Each health tracker includes a means for periodically
`uploading the collected data to the database. In the preferred
`embodiment,
`the health trackers communicate with the
`database via a public information network. The monitors are
`connected to the network by a communications device such
`as a modem. Oncestored in the database, the data may be
`later accessed by an authorized physician or by the patient.
`Because the data is logged by patient and time-index. the
`data can be recovered for a particular patient and a particular
`time period with relative ease. The data stored by the present
`invention in the database is of particular value for identify-
`ing trends in healthy persons due to the fact that it
`is
`collected regularly,
`irrespective of the patient’s medical
`condition. The invention thus provides a powerful
`tool
`previously unavailable to physicians for the early detection
`of adverse medical conditions.
`The multiparametric physiological monitor is a portable
`unit for continuous monitoring of certain physical param-
`eters of the patient. In the preferred embodiment. the moni-
`tor sensors include EKG electrodes, a chest expansion
`sensor, an accelerometer, a chest microphone, a barometric
`pressure sensor, ap underarm temperature sensor, a pecto-
`ralis temperature sensor and an ambient temperature sensor.
`Eachof the sensors provides an output signal to an analog-
`to-digital converter (ADC) which is controlled by a real-
`time (RT) controller. The RT controller is preferably a digital
`microcontroller which runs a program that collects data from
`the sensors and transmits the collected data to a second
`controller, referred to as the “memory server” (MS)
`controller. to be stored.
`The MScontroller, like the RT controller. is preferably a
`digital microcontroller. The MS controller runs a program
`that compresses the data received from the RT controller,
`where appropriate, and stores it in a random access memory
`(RAM). In addition, the MS controller is responsible for
`communications with external entities such as a database
`server.
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`5.778.882
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`3
`In the preferred embodiment. electrocardiogram (EKG)
`data is reduced and compressed, and ventilation (chest
`expansion sensor) data is reduced. The ventilation data is
`reduced by storing a series of time interval/amplitude pairs
`that comprise a straight-line approximation of the chest
`expansion signal. The straight-line approximation uses the
`significant events in this signal, such as the inflection points
`in the breathing cycle. and the start and stop of breathing
`plateau periods (i.e. extended times of stable chest
`circumference), as well as sharper inflections associated
`with sneezing, coughing or retching.
`EKGdata. sampled mostfrequently, is reduced by storing
`only timing information for each heartbeat (QRS complex)
`and. once per minute. storing the median values of various
`components of a straight-line approximation of the QRS
`complex. The heartbeat interval information is compressed
`by storing the differences in interval duration rather than the
`interval itself where possible. and storing the interval dif-
`ferences in formats which take advantage of their com-
`pressed size.
`The RAM is divided into three regions: 1) the scratchpad;
`2) the warehouse (long-term storage of all but 8-bit EKG
`data); and 3) the 8-bit EKG data area. As data is received,it
`is placed in the scratchpad. As time permits, data is read
`from the scratchpad. processed, and stored in the warehouse
`or the EKG zone, depending on the data type and size. The
`MScontroller stores data received from the RT controller in
`the scratchpad in the packetized format in which it was
`received. When not busy with other tasks, the MS controller
`processes data temporarily stored in the scratchpad and
`placesit in variable-length fields in the warehouseor fixed-
`length fields in the EKG zone. The data in the warehouse is
`tagged using a coding method which identifies the data type
`with a particular sequenceof leading bits. This allows proper
`reassembling of data as it is read out of memory.
`In the preferred embodiment, the subjective data logger
`uns a user-friendly data collection program which prompts
`the patient to report subjective data or simply serves to
`structure a voluntary submission of a report. This data is
`timestamped and stored in a local memory unit of the data
`logger for later uploading to the database. The monitor and
`the data logger may be linked together to connect to the
`database as a single unit via a public data network or other
`conununication medium. Alternatively,either of the monitor
`and the data logger may individually connect to the data-
`base.
`
`Oneparticular feature of the present invention involves
`the use of a capsule which contains a patient’s medication,
`along with a miniature pulse generator and transmitter.
`Whenthe capsule is ingested and dissolves in the patient’s
`stomachacid, the medication is liberated and the transmitter
`is activated. The transmitter transmits a pulsed signal which
`is uniquely identified with the medication in the capsule. The
`signal is detected by the EKG electrodes of the monitor on
`the surface of the patient’s skin, and is decoded by the
`monitor firmware to automatically identify which drugs are
`ingested by the patient and when they are taken.
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 is a schematic overview of a health monitoring
`system in accordance with the present invention.
`FIG. 2 is a front view of a portable multiparametric
`monitor which is part of a preferred embodiment of the
`present invention.
`FIG.2A is a top view of a patient wearing the multipara-
`metric monitor which shows the desired locations of EKG
`electrodes of the monitor.
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`FIG. 3 is a block diagram of a portable multiparametric
`monitor of the present invention.
`FIG. 4 is a schematic depiction ofthe hardware of a
`portable multiparametric monitor of the present invention.
`FIG. 5.
`is a memory map of the RAM memory of a
`portable multiparametric monitor of the present invention.
`FIG. 6 is a table of the service groups for data collected
`by a portable multiparametric monitor of the present inven-
`tion.
`
`FIG.7 is a representation of how data is stored in RAM.
`FIG. 8 is a graphical depiction of a EKG waveform
`demonstrating the EKG sampling points of the multipara-
`metric monitor of the present invention.
`FIG. 9 is a flow chart depicting a software routine ofa real
`time controller of the multiparametric monitor.
`FIG.10 is a flow chart depicting an interrupt routineof the
`real time controller.
`
`FIGS. 11A-11D together make up a flow chart depicting
`an EKGsignal processing routine of the real-time controller.
`FIGS. 12A and 12B depict a flow chart of a ventilation
`signal processing routine of the real time controller.
`FIG. 13 is a flow chart depicting a plateau detection
`function used during the ventilation signal processing rou-
`tine of the real time controller.
`
`FIG. 14 is a flow chart depicting a software routine of a
`memory server controller of the multiparametric monitor.
`FIG. 15 is a front view of a subjective data logger of the
`present invention.
`FIG. 16A depicts a “pain location” screen display of the
`subjective data logger on which a front view of a human
`body is shown
`FIG. 16B depicts a “pain location” screen display of the
`subjective data logger on which a rear view of a human body
`is shown.
`
`FIG. 16 depicts a “pain location” screen display of the
`subjective data logger on which a magnified view of a
`particular portion of a human body is shown
`FIG. 17 depicts a “pain history” screen display of the
`subjective data logger.
`FIG. 18 depicts a “mood” screen display of the subjective
`data logger.
`FIG. 19 depicts a “medication history” screen display of
`the subjective data logger.
`FIG. 19A depicts a “side effects” screen display of the
`subjective data logger.
`FIG. 20A depicts a message screen upon which a user
`may enter a message to be received by a party monitoring
`the database.
`
`FIG. 20B depicts a message screen upon which a user
`receives messages and interactive questions from a party
`monitoring the database.
`FIG. 21 is an exploded view of an “electronic pill” used
`with an alternative embodiment of the multiparametric
`monitor of the present invention.
`
`DETAILED DESCRIPTION OF A PREFERRED
`EMBODIMENT
`
`Shownin FIG.1 is a health tracking system 100 which has
`a central database 162 with a data link connectable to each
`of a plurality of health trackers 104. In the preferred
`embodiment, each of the health trackers 104 includes a
`multiparametic physiological monitor 108 and a subjective
`data logger 106. In the preferred embodiment the monitor
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`5,778,882
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`5
`108 connects directly to a modem 110 (when used without
`a data logger 106), or can be connected to a serial data port
`on the subjective data logger which, in turn, connects to a
`modem 116.
`In the preferred embodiment an external
`modem is used primarily because of lower cost, however
`those skilled in the art will recognize that it would also be
`possible to include a single chip modem in the monitor 108
`or to plug a PCMCIA modeminto the data logger 106. The
`external modem of the preferred embodimentalso includes
`a chargepad for recharging the batteries of the portable
`monitor 108 and data logger 106 units.
`The monitor 108 and the data logger 106 collect data from
`the patient whichis time stamped and stored locally for later
`uploading to the central database 102. Those skilled in the
`art will recognize that the “central” database may actually be
`a plurality of databases. However. for the purposes of this
`description, the database will be described as a single unit.
`Preferably, the data link from each of the health trackers-
`108 and each of the data loggers 106 to the database is
`established using an associated modem 110, and some
`combination of a telephone network and a data network. In
`the present embodiment. the modem 110 directly connects
`via telephone to one of the computers that support the
`database 102. In the alternative, the modem may connect to
`a local network access computer and transmit data to the
`database via the network connection. Those skilled in the art
`will recognize that there is a variety of meansto transfer data
`from site to site, and that different means may be chosen at
`anytime based on cost and convenience.
`The monitor 108 collects objective data on the patient’s
`physical condition via a plurality of automatically-
`controlled physiological sensors. The subjective data logger
`collects subjective information from the patient by providing
`the patient with an input device having data prompts such as
`questions regarding the patient’s condition. Within the con-
`text of this description, the term “‘objective” data will refer
`to that data which is obtained by sensing the patient’s
`physiological parameters. Correspondingly, the term “sub-
`jective” data will refer to that data which is input by the
`patient to the data logger 106, regardless of whetherthat data
`pertains to the patient or the patient’s environment, and
`whether or not the information is objective or factual. such
`as medication dosage or consumption of a particular food.
`Referring to FIG. 1, a medical records database 114
`contains information regarding patient medical histories.
`Also shown graphically in FIG. 1 is a depiction of a hospital
`116 and a physician’s office 118. The hospital 116 and
`physician’s office also have data connections with database
`102 to allow the transfer of data to and from the database.
`In addition, the database 102 has a direct connection to the
`medical records database to allow the transfer of information
`directly between the two locations. Although only one
`hospital building and one physician’s office are shownin the
`figure. those skilled in the art will recognize that there can
`be. and are likely to be, a large number of hospitals and
`physicians offices with communications links to the medical
`records database 114. In addition. a number of personnel not
`directly related to patient care may be located at these and
`other sites, similarly connected over a public or private
`network, who will be performing data management and
`analysis services.
`
`Multiparametric Monitor
`
`Shown in FIG. 2 is multiparametric monitor 108. The
`monitor 108 comprises a body strap which, in the preferred
`embodiment, is a chest strap 124 upon which are distributed
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`6
`various sensors and supporting electronics. (at will be rec-
`ognized by those skilled in the art that a multiparametric
`monitoring device may also be mounted by a strap about a
`part of the body other than the chest). As shown in the top
`view of FIG. 2A. the cheststrap 124 fits around the torso of
`a patient 120.
`In the preferred embodiment. all of the
`electronics and sensors are configured in the flexible strap
`itself such that the monitor is completely selfcontained. That
`is. the chest strap 124 includes a number of flexible con-
`ductors which are embedded in the strap. The various
`components are mounted in the strap, and are interconnected
`via the embedded conductors. In the preferred embodiment.
`the belt. sensors and accompanying electronics have a thin
`profile, and the strap is a consistent 0.9 inches wide along its
`length. Most of the monitor is less than 0.20 inches thick,
`except for an area containing the batteries 129 and an area
`containing the chest expansion sensor and accelerometer,
`each of which is approximately 0.3 inches thick.
`A variety of parametric sensors are supported by the
`monitor, each being located on the strap 124 as most
`‘appropriate for the parameter (or parameters) which it
`detects. Each of the sensors provides an electrical input to
`analog circuitry which filters and amplifies the sensor
`signals, as knownin the art of signal processing, and outputs
`them to an analog-to-digital converter. which is part of
`monitor hardware 144. The hardware 144 of the monitor 108
`receives data from the sensors in a manner which is dis-
`cussed in detail with reference to FIG. 4. The identification
`of the following sensors in FIGS. 2 and 2A is intended to
`describe a preferred embodiment for the sensors and their
`locationsrelative to the patient’s body. and is not intended
`to limit the use of other sensors or other positioning of
`sensors with the present invention.
`The sensors (shown in block diagram form in FIG. 3) are
`as follows: pectoralis temperature sensor 128, which senses
`the temperature of the surface of the patient’s chest; baro-
`metric pressure sensor 130, which senses the ambient baro-
`metric pressure of the patient’s environment; chest expan-
`sion (ventilation) sensor 132, which detects the tension on
`the chest strap 124 as an indication of the expansion and
`contraction of the patient’s chest; accelerometer 134, which
`detects movement and inclination of the patient’s body;
`ambient temperature sensor 136, which senses the ambient
`temperature of the patient’s environment; microphone 138.
`which detects sounds from within the