US006398727B1
`(10) Patent No.:
`a2) United States Patent
`US 6,398,727 B1
`
` Bui et al. (45) Date of Patent: Jun. 4, 2002
`
`
`(75)
`
`(54) METHOD AND APPARATUS FOR
`PROVIDING PATIENT CARE
`N
`N
`Inventors: Tuan Bui, Green Oaks, IL (US);
`Thomas Cooper, Fricndswood, TX
`(US); Clint Deckert, Poway, CA (US);
`Doron Levitas, Chicago, IT. (US); Emil
`S. Macha, Sugar Land, TX (US); Shan
`Padda, Chicago, IL (US); Arthur
`Schulze, Wharton, TX (US)
`
`(73) Assignee: Baxter International Inc., Dearfield, IL
`(US)
`Subject to anydisclaimer, the term ofthis
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`(*) Notice:
`
`(21) Appl. No.: 09/219,664
`
`(22)
`Filed:
`Dec. 23, 1998
`(51) Tt. C1. oaneeeeee ceceseseeeeeensseeeeetnseneees A6IB 5/00
`(52) UNS, Che oo ecccccecceeesecesteeetteeteees 600/300; 128/904
`(58) Field of Search oo...eee 600/300, 301;
`128/903, 904
`
`;
`(56)
`
`.
`References Cited
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`OTHER PUBLICATIONS
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`(List continued on next page.)
`Primary Examiner—Robert L. Nasser
`(74) Attorney, Agent, or Firm—Wallcnstcin & Wagner,
`LTD
`
`(57)
`
`ABSTRACT
`
`A patient management system includes a programmable
`patient monitor for monitoring and recording a plurality of
`physiological conditions of a patient, a plurality of physi-
`ological condition sensors and a communications unit. The
`plurality of patient monitoring sensors are electrically
`coupled to the programmable patient monitor. Each sensor
`detects a particular physiological condition of the patient,
`such as core temperature, ECG electrodes for providing an
`electrocardiogram and blood oximetry sensors. The patient
`monitor is small and compactand easily worn bythe patient
`during his normal at homeactivities. To provide communi-
`calion with a caregiver via a remote controller at
`the
`caregiver’s location, a communications unit is disposed in
`the facility. The communications unit may be selectively
`:
`.
`.
`coupled to the programmable patient monitor for receiving,
`storing and transmitting to the remote controller patient
`physiological condition data and for transmitting instruc-
`tions from the remote controller to the programmablepatient
`monitor. When the patient connects the patient monitor to
`the communications unit, the patient can communicate with
`the caregiver at the remote location.
`
`(List continued on next page.)
`
`87 Claims, 68 Drawing Sheets
`
`v
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`SPIROMETER[~~
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`
`
`
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`| 218|CORE TEMP, TEMP, |~-56
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`
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`
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`40 NW —
`OTHER DEVICES
`+40
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`eeeeee ORPATIENT'SHOME
`TELEPHONELINES
`
`
`
`
`
`
`|~53
`58
`
` es
`
`
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`
`CAREGIVER'S OFFICE
`
`
`
`
`
`
`
`
`APPLE 1079
`Apple v. Masimo
`IPR2022-01291
`
`1
`
`APPLE 1079
`Apple v. Masimo
`IPR2022-01291
`
`

`

`US 6,398,727 B1
`
`Page 2
`
`U.S. PATENT DOCUMENTS
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`—
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`. 364/413.03
`
` “IEEE-488 and VXIbus Control, Data Acquisition, and
`4,810,243 A
`3/1989 Howson wees 60431
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`.
`. the Most Choices,” select pages taken from
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`4,850,972 A
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`.
`604/151
`
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`
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`pp. 1-36.
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`. 364/413.01
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`.
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`csoon ‘
`a,1990 Miyagaki et al.
`......... 364/190
`.
`952,
`/1990 Carroll et al.
`......... 340/825.54
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`. 73/861.05
`2/1991 Ash et al.
`....
`
`Annual Conference On Engineering In Medicine And Biol-
`5,038,800 A
`.. 128/904
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`ogy, Nov. 5-9, 1977; pp. A-35827 through A-35837.
`5,078,683 A
`. 604/67
`1/1992 Sancoff elal. ..
`
`Selective portions of Chapter 9 of Mayhew,“Principles and
`5,100,380 A
`.....
`. 604/67
`3/1992 Epstein et al.
`
`Guidelines In Software User Interface Design,” Prentice
`5,109,849 A
`.......... 128/633
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`Hall PTR, Englewood Cliffs, New Jersey, 1992.
`5,115,133 A
`5/1992 Knudson ........ see 250/341
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`ae ‘
`3foo. Rankenship “ a sereeteeseis
`.
`“
`-
`.
`A
`’
`”
`5137,
`endelsonet al.
`wes
`
`ened Who Will Dominate the Desktop in the °90s,” pp.
`5,152,296 A
`10/1992 Simons
`veevecssseseeseeseee 128/670
`.
`:
`cane
`.
`45
`:
`5,153,827 A
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`Chapter 5 entitled “Direct Manipulation from Shneiderman
`5,155,693 A
`10/1992 Altmayeretal.
`.. 364/550
`
`“Designing the User
`Interface: Strategies for Effective
`5,165,874 A
`.....
`.. AL7/474
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`Human-Computer Interaction,” Addison-Wesley Publish-
`5,167,235 A
`.
`... 128/664
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`
`ing Company, Second Edition, ©1992, reprinted with cor-
`5,191,891 A
`3/1993 Righter ...........
`... 128/710
`rections 1993.
`5,207,642 A
`5/1993 Orkin et al. oe 604/65
`Literature of Baxter’s Multiplex™ Series 100 Fluid Man-
`5,213,099 A
`5/1993 Tripp, It. sce 128/633
`agement System, 2 pp., no date listed.
`5,226,425 A
`7/1993 Righter .....ssseeesesessee 128/710
`
`5,230,623 A 7/1993 Guthrie et al. essere 433/72_Titerature of Baxter “Introducing MultiPlex™ Series 100
`
`wee 604/246
`5,256,157 A
`10/1993 Samiotes et al.
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`
`. 340/825.06
`5,291,190 A
`3/1994 Scarola et al.
`..
`:
`oe
`?
`-.. 364/188
`5,205,062 A
`3/1994 Fukushima.....
`Literature describing Baxter’s FLO-GARD® 6201 Volu-
`
`... 128/665
`5,297,554 A
`3/1994 Glynn etal. ....
`‘metric Infusion Pump, copyrighte 1992.
`5/1994 Coutré et al. wc... 364/413.02
`5,317,506 A
`Literature of I-Flow Corporation advertising its Virus 4000
`8/1994 Blomquist v.00... eee 417/2
`5,338,157 A
`Infusion System.
`
`5,361,758 A
`11/1994 Hall etal.
`128/633
`One-—pagearticle by Jerry Hirsch entitled “Portable IV Frees
`11/1994 Blomquistetal. ............ 604/65
`5,368,562 A
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`12/1994 Purvis etal. we. 604/31
`5,376,070 A
`Nov. 21, 1991.
`
`5,378,231 A
`1/1995 Johnsonetal. ....
`604/67
`Bedder, et al., “Cost Analysis of Two Implantable Narcotic
`
`....
`5,395,321 A
`3/1995 Kawahara ct al.
`604/67
`.
`”
`.
`3/1995 Fleilschhackorel al.
`....., 604/95
`5.305.329 A
`Delivery Systems,” Journal of Pain and Symptom Manage-
`.. 364/146
`.....
`5,400,246 A
`3/1995. Wilson etal.
`‘ment, vol. 6, No. 6, Aug., 1991, pp. 368-373.
`
`.. 345/119
`5,412,400 A
`5/1995 Takahara et al.
`Peter Lord, Hossein Allami, Mark Davis, Raul Dias, Patrice
`....cccecccceceeteeees 604/65
`5,429,602 A
`TIN99S Hauser
`Heck, and Robert Fischell, pp. 66-71 from book chapter
`5,469,855 A
`11/1995 Pompei etal. ..........0. 128/664
`entitled “MiniMed Technologies Programmable Implantable
`
`........ 417/474
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`5,482,446 A
`Infusion System,” describingclinicaltrials from Nov., 1986.
`
`pe seeeees
`nee 364/578
`5,485,408 A
`1/1996 Blomquist
`“IMED®STATUS™ Infusion Management System,” 6 page
`Fukami....
`+ 128/670
`5,509,422 A
`4/1996
`brochure, IMED Corporation, San Diego, CA,no date listed.
`
`6/1996 Langeretal.
`.. 128/696
`5,522,396 A
`:
`“
`8/1996 Wille secceecoseeee.
`_. 128/633
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`James D. Foley and Andries Van Dam “Fundamentals of
`9/1996 Evers et al. veceseecseeees 604/66
`5,558,638 A
`‘Interactive Computer Graphics,” selected pages from Chap-
`5,573,506 A
`11/1996 Vasko wvceeeceseeeeeeees 604/65
`ters 1 and 2, Addison—Weslcy Publishing Company, ©1982,
`5,582,593 A
`12/1996 Hultman oo... 604/65
`reprinted with corrections 1983.
`
`
`
`
`
`2
`
`

`

`U.S. Patent
`
`Jun. 4, 2002
`
`Sheet 1 of 68
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`US 6,398,727 BI
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`U.S. Patent
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`Jun.4, 2002
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`Sheet 2 of 68
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`US 6,398,727 B1
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`FIG. 2
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`

`

`U.S. Patent
`
`Jun.4, 2002
`
`Sheet 3 of 68
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`US 6,398,727 B1
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`U.S. Patent
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`Jun.4, 2002
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`Sheet 4 of 68
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`US 6,398,727 B1
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`U.S. Patent
`
`Jun. 4, 2002
`
`Sheet 5 of 68
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`US 6,398,727 B1
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`FIG. 4
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`

`U.S. Patent
`
`Jun.4, 2002
`
`Sheet 6 of 68
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`US 6,398,727 B1
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`U.S. Patent
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`Jun. 4, 2002
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`Sheet 16 of 68
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`

`U.S. Patent
`
`Jun. 4, 2002
`
`Sheet 17 of 68
`
`US 6,398,727 B1
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`g1z
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`

`

`U.S. Patent
`
`Jun.4, 2002
`
`Sheet 18 of 68
`
`US 6,398,727 B1
`
`FIG. 8G
`AD[0..7]
`A{0..7]
`CAL..7]]
`
`.
`
`CONTRAST
`
`CONTROL
`iOK POT
`
`BACK LIGHT CONTROL
`BK LT CTRL
`
`J3
`
`CHARLCD
`DISPLAY
`MODULE
`
`219
`
`PIN 15,
`BL-CATHODE
`PIN 16, ANODE
`
`HEADER16
`
`FLASH A[13..[13..20]}|FLASH A[13..20]] ovcc POT1
`
`ol,
`
`74HC3TA
`
`12
`43
`
`|
`L
`
`20
`
`20
`
`

`

`U.S. Patent
`
`Jun.4, 2002
`
`Sheet 19 of 68
`
`US 6,398,727 B1
`
`cg
`0.1UF
`
`|1
`
`20,
`19
`18
`
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`— OOO 7
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`
`<PULLUP17]
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`PULLUP18
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`
`21
`
`21
`
`

`

`U.S. Patent
`
`Jun.4, 2002
`
`Sheet 20 of 68
`
`US 6,398,727 B1
`
`FIG. 81
`AD[0..7]
`
`ECG 6 VIWV>Foe cavity<ECGLEADOFFECGG1V/HV
`ECG GIVINV
`>or sHuTDO
`TCT SHUTDOWN
`WN
`ECG SIGNAL
`TCT PREHEAT
`>CT PREHEAT
`16.384 KHZ
`
`J2
`
`ECG LEAD OFF
`ECG SIGNALICTVHIR|
`CT SKIN SIGNAL
`CT HEATER SIGNAL
`TCT VHIR
`RESP SIGNAL
`
`RESP SENSOR DETECT<RESPSIGNAL,
`OX SERIAL DATA
`RESP SENSOR DETECT
`OX SERIAL DATA
`
`8 9 1 1 1 1
`
`T T
`
`
`
`BOARD-TO-BOARD
`
`INTERCONNECT Tall
`
`a be
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`ve
`
`PG
`
`|
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`
`vcc
`OO
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`ISOLATED + 5V
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`* SVE
`
`22
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`VCC
`
`ND
`
`DGNo}_—DSND
`
`<—
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`
`22
`
`

`

`U.S. Patent
`
`Jun.4, 2002
`
`Sheet 21 of 68
`
`US 6,398,727 B1
`
`FIG. 8J
`
`FA
`BT2
`oN
`opt
`= 3VNICAD PICOFUSE..5AMP
`VGC
`
`D2
`4N5818
`
`R4
`100
`
`DATA
`4=POWERIS
`OFFICIALLY UP
`0=POWERIS
`OFFICIALLY DOWN
`ADO
`1C5 ALARM
`
`VCC
`©
`
`VALARM
`C)
`
`C10
`0.1UF
`=
`
`1, U10A
`PR g|S_HLON
`u10
`CLK
`_J|¢
`VALARM TOPIN 14
`cL @
`DGND TO PIN7
`Y 74LVC74
`
`D3
`
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`
`PWR SENSE
`2R5
`400K
`
`226
`= VALARM
`
`
`
`VALARM
`10) utop
`?
`VALARM|12/, PR g|2
`o
`11
`CLK
`_J\g
`JP5
`R6
`5
`.
`JUMPER, BKUP
`100K
`ok
`ALARM
`13
`|/HDO> PHDO |F ON7001
`
`23
`
`23
`
`

`

`U.S. Patent
`
`Jun. 4, 2002
`
`Sheet 22 of 68
`
`US 6,398,727 BI
`
`OILSONSVIG
`
`LuOd
`
`pLEOHPL 48“Sls
`
`24
`
`24
`
`

`

`U.S. Patent
`
`Jun. 4, 2002
`
`Sheet 23 of 68
`
`US 6,398,727 BI
`
`
`
`3OvdNVUS<12"olay>
`
`oveees [DOA
`
`JOA
`
`25
`
`25
`
`
`

`

`U.S. Patent
`
`Jun.4, 2002
`
`Sheet 24 of 68
`
`US 6,398,727 B1
`
`FIG. 8M
`
`
`
`vcc
`©
`
`PULLUP12
`
`C16
`0.4UF
`
`
`
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`oS
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`2
`|/DSRIN>
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`le
`
`iT DTR
`<[DTROUT]
`|~32 RESET
`DS
`RESET
`D6
`OP1 P37_/DTROUT i
`
`D7 DIR P36 /RTS OUT|_
`
`aT Rok <URTSOUT|a 0-35
`
`ta NC
`295
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`rag|oso =INT|INT <UART
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`
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`L147 Bau
`
`TP15
`> DSR
`
`1
`
`P14
`
`
`
`
`
`4| RXRDY
`
`26
`
`26
`
`

`

`U.S. Patent
`
`Jun.4, 2002
`
`Sheet 25 of 68
`
`US 6,398,727 B1
`
`FIG. 8N
`
`[CCL PCR
`
`CCLK
`
`RESET
`FLASHA[13..20]
`
`! CS EXTSRAM
`
`:
`:
`
`RESET
`FLASHA[13..20]
`TCS EXTSRAM
`
`|
`]
`
`
`
`
`
`TCSRIS
`
`ECLK
`
`Luni
`
`TP8
`|RTC_INT
`O
`
`1
`
`4]
`
`OTP
`SQW_OUTPUT
`16.304 KHZ
`
`27
`
`27
`
`

`

`U.S. Patent
`
`Jun. 4, 2002
`
`Sheet 26 of 68
`
`US 6,398,727 BI
`
`Int
`
`who
`
`,|CassCN|LeeLas
`eaeDOA
`(Mode|o1ev
`iHPoh
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`
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`
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`
`28
`
`28
`
`
`
`
`

`

`U.S. Patent
`
`Jun.4, 2002
`
`Sheet 27 of 68
`
`US 6,398,727 B1
`
`FIG. 8P
`
`
`ISOLATED +5V
`FROM DC /DC CONV
`
`
`AT PCM2000 CONN
`EMEOnears |
`D4
`OFF-BOARD
`
`|
`Pi
`| Jt
`
`PZ
`ae] ak
` INSO10
`=. 1A FUSE
`
`
`RESETABLE
`
`
`[BATTERIES 2pos | 2PIN
`
`R10
`3 AA CELLS
`10K
`Ld
`
`vecO
`
`29
`
`29
`
`

`

`U.S. Patent
`
`Jun.4, 2002
`
`Sheet 28 of 68
`
`US 6,398,727 B1
`
`FIG. 8Q
`
`LINE DETECT ( ANALOG )
`LoweATTERY=Bestious
`R14
`MONITOR ( ANALOG)
`K
`LOW BATTERY MONITOR
`“9
`BATT VOLTAGE
`TOUC A/D
`FOR LOW BATTERY
`
`vCC VCC SOURCE
`OO
`+ BV
`
`
`
`
`
`
`
`
`
`
`
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`
`PWR SWITCH TERMA
`1Pé JUMPER PWR
`O
`7
`FROM POWER
`© GND JUNCTION
`
`|[PGND| PWRSWITCHTERMB
`
`
`
`
`[SenFsan)SEND|
`
`
`
`0
`SWITCH
`DEPRESSED
`
`
`DETECT
`POWER SWITCH
`
`
`INSO10
`
`DETECT
`
`R16
`
`
`POWER ON CONTROL
`2N7001
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`
`4 = POWER SECURED
`
`POWERON CONTROL
`0 = POWER TERMINATED
`
`
`
`POWER ON CONTROL
`
`
`R15
`LOW VOLT
`100K DROPOUT
`TO UC
`1 = POWER OK
`0 = POWER DROPOUT
`
`LOW VOLT
`DROPOUT
`
`LOW VOLT
`DROPOUT
`
`
`
`TO UC POWER
`SWITCH DETECT
`0 = POWER SWITCH
`
`© JP4 JUMPER,
`© SIQ GND JUNCTION
`
`
`
`30
`
`30
`
`

`

`U.S. Patent
`
`Jun.4, 2002
`
`Sheet 29 of 68
`
`US 6,398,727 B1
`
`FIG. 8R
`
`
`
`100PF |100PF|100 PF/100PF
`
`
`
`31
`
`31
`
`

`

`U.S. Patent
`
`Jun.4, 2002
`
`Sheet 30 of 68
`
`US 6,398,727 B1
`
`FIG. 8S /CTSIN
`
`|
`
`cos
`
`OPTO
`ve
`“||ISOLATOR
`
`OC4
`
`OC5
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`ISOLATOR
`
`s
`
`R54 TxD OUT
`<TX]
`OK
`4
`
`OC6
`OPTO
`ISOLATOR
`R55 RTS OUT
`<RTS]
`0K
`4
`
`x
`
`32
`
`32
`
`

`

`U.S. Patent
`
`Jun. 4, 2002
`
`Sheet 31 of 68
`
`US 6,398,727 BI
`
`
`
`Cheldebe
`
`Bu
`
`M02
`
`6Y
`
`0c
`
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`
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`
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`
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`
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`
`33
`
`33
`
`
`
`

`

`U.S. Patent
`
`Jun. 4, 2002
`
`Sheet 32 of 68
`
`US 6,398,727 BI
`
`OL
`
`bbOL#8'b=NIVD
`
`0904
`
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`
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`
`34
`
`34
`
`
`

`

`U.S. Patent
`
`Jun.4, 2002
`
`Sheet 33 of 68
`
`US 6,398,727 B1
`
`FIG. 9C
`
` 220
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` C40
`
`|
`
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`
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`
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`
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`
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`
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`FC = 50HZ
`
`TP2
`
`35
`
`35
`
`

`

`U.S. Patent
`
`Jun. 4, 2002
`
`Sheet 34 of 68
`
`US 6,398,727 BI
`
`jr2
`
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`
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`36
`
`36
`
`
`

`

`U.S. Patent
`
`Jun. 4, 2002
`
`Sheet 35 of 68
`
`US 6,398,727 B1
`
`FIG 10A
`
`.
`
`VR
`
`R56
`
`2.21M
`TSKIN
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`
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`
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`
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`
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`
`37
`
`37
`
`

`

`U.S. Patent
`
`Jun. 4, 2002
`
`Sheet 36 of 68
`
`US 6,398,727 BI
`
`VCC
`
`OFIG. 108
`
`5
`
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`

`

`US 6,398,727 BI
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`U.S. Patent
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`Jun. 4, 2002
`
`Sheet 37 of 68
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`130SN3SU
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`

`U.S. Patent
`
`Jun. 4, 2002
`
`Sheet 38 of 68
`
`US 6,398,727 BI
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`

`U.S. Patent
`
`Jun. 4, 2002
`
`Sheet 39 of 68
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`yzUSQVSH7eNOS.
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`
`US 6,398,727 B1
`
`41
`
`41
`
`
`

`

`U.S. Patent
`
`Jun. 4, 2002
`
`Sheet 40 of 68
`
`US 6,398,727 BI
`
`TVOOTVAVad <->
`
`Gyyag«SaHINWSWLTSQ/009=SveHLvaua
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`42
`
`42
`
`

`

`U.S. Patent
`
`Jun.4, 2002
`
`Sheet 41 of 68
`
`US 6,398,727 B1
`
`MOVEALL RING BUFFER
`POINTERS FORWARD. CLEAR FLAG.
`
`602
`
`PERFORM LARGE|604
`WINDOW DETECTION
`
`606
`
`TRUE
`
`608
`
`TRIPPED? — SET FLAG
`
`FALSE
`
`PERFORM SMALL|610
`WINDOW DETECTION
`
`61
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`TRUE
`TRIPPED ? SET FLAG|_"4
`
`
`
`NO PEAK DETECTED,
`CONTINUE WITH SEARCH
`
`TRUE
`
`620|PERFORM NARROW REJECTION
`WINDOW DETECTION
`
`FALSE a ate
`FALSE
`
`61
`‘
`
`
` DO NO SEARCH,UNTIL
`
`622
`
`TRIPPED ?
`
`SEARCH POINTER HAS GONE
`PAST THE PEAK
`
`626
`
`FALSE
`
`
`
`
`
`LOCATE THE LOCAL MAXIMA OF THE PEAK,
`MARK ITS RESPECTIVE SAMPLE NUMBER.
`SUBTRACT THE LAST PEAK’S SAMPLE NUMBER
`FROM THIS ONE.
`
`43
`
`43
`
`

`

`U.S. Patent
`
`Jun.4, 2002
`
`Sheet 42 of 68
`
`US 6,398,727 B1
`
`FIG. 13B
`
`
`
` TRUE| FAILED RESONABLE VALUE,
`
`628
`
`
`IS DIFFERENCE < 10?
`IGNORE THE PEAK,
`
`CONTINUE SEARCH
`
`
`
`FAILED RESONABLEVALUE,
`
`TRUE
`
`BUT RECORD THIS PEAK AS A
`
`
`
`
`REFERENCE FOR
`FUTURE PEAKS.
`
`
`
`PASSED--
`638
`SAVE THE MAXIMA
`
`
`SAMPLE POINT
`AS REFERENCE.
`
`
`PERFORM THE
`
`
`
`DO NO SEARCH,UNTIL
`WEIGHTED AVERAGE.
`SEARCH POINTER HAS GONE
`
`
`
`CALCULATE AND OUTPUT
`PAST THE PEAK
`
`
`
`THE INSTANTANEOUS
`
`
`BREATH RATE, AND
`THE WEIGHT AVERAGE
`BREATH RATE
`
`
`IS DIFFERENCE> 140?
`
`634
`
`44
`
`44
`
`

`

`U.S. Patent
`
`Jun. 4, 2002
`
`Sheet 43 of 68
`
`US 6,398,727 BI
`
`
`
`
`
`GNOORSY3d3ONOgz
`
`
`
`CryVel‘SIs
`
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`
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`dSiy4Os
`
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`
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`oes
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`
`INAYYNDAd
`
`NOlLdld¥oSdSd
`
`45
`
`45
`
`
`
`
`

`

`U.S. Patent
`
`Jun.4, 2002
`
`Sheet 44 of 68
`
`US 6,398,727 B1
`
`FIG. 14B
`
`GET TIMESTAMP FROM RTC 546
`AND STUFF INTO RECORD
`
`548
`
`TRUE
`
`{SET 10 SEC DURATION
`TIME ON FIRST DETECT
`
`
`552
`FALSE
`TRUE|SET ECG
`RESET ECG ALERT
`EXPIRED 2
`ALERT
`TIMER
`
`se
`a
`
`550
`
`556
`
`PLACE CURRENT ECG
`GAIN VALUEIN STATUS
`
`560
`
`UPDATE RECORD WITH
`MOST CURRENT STATUSj562
`
`ADDITIONALLY SET STATUS|
`TO"PRETRIGGERED"
`
`|
`
`554
`
`RECORD RECORD TO THE
`FIFO MEMORY USING
`
`FIFO INDEX
`
`46
`
`46
`
`

`

`U.S. Patent
`
`Jun.4, 2002
`
`Sheet 45 of 68
`
`US 6,398,727 B1
`
`FIG. 14C
`
`@
`
`INCREMENT INDEX AND]
`REMOVE "PRETRIG"
`FROM STATUS
`
`568
`
`570
`IS RECORD
`FLAG SET?
`
`RESET RECORD FLAG
`
`PERFORM RECORD
`WRITE TO FLASH
`
`of2
`
`574
`
`
`
`
`
`
`TRUE
`
`FLASH HEAD INDEX
`= TAIL INDEX?
`
`
`
`MOVE INDEXES?
`
`576
`
`580
`
`[SET MEMORY
`FULL ALERT
`
`RESET MEMORY
`FULL ALERT
`
`
`
`INITIATE A 64K
`
`
`WITHIN 62 RECORDS
`
`BYTE BLOCK
`OF NEXT 64K FLASH
`ERASE OF
`
`
`
`ERASE SEGMENT?
`
`
`
`UPCOMING
`SEGMENT
`
`
`
`588
`
`END OF LOOP
`
`47
`
`47
`
`

`

`U.S. Patent
`
`Jun.4, 2002
`
`Sheet 46 of 68
`
`US 6,398,727 B1
`
`FIG. 15A
`
`700
`
`BEGIN LOOP
`
`
`GREATER
`THEN 1 SEC
`
`ELAPSED?
`
`
`
`
`PUT RECEIVE CHAR
`IN OX BUFFER, INC
`OUTER
`
`
`
`re
`SET CALC FLAG
`
`
`GREATER THAN
`COPY DATAINTO
`3? — PUBLICBUFFER -
`
`
`
`
`MORE THAN
`1 TICK ELASPED?
`
`A3 SERIAL
`CHAR BURST
`EXPECTED
`EVERY SECOND
`
`
`
`
`
`48
`
`48
`
`

`

`U.S. Patent
`
`Jun. 4, 2002
`
`Sheet 47 of 68
`
`US 6,398,727 B1
`
`
`
`LYTy¥13S
`‘DV1d13S|sty
`YAWILLAS
`YS
`
`20380+NVHLSHOW
`VIS
`
`
`
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`CSLSISYadLUSTYoc,|‘LuaTVLaSSY
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`
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`
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`FAS1NdGVEMOVEL
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` é<cOdSdvd/vLvdGvd
`
`49
`
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`
`SLYATV
`
`LN3W39VNVW
`
`49
`
`
`
`
`
`
`

`

`U.S. Patent
`
`Jun.4, 2002
`
`Sheet 48 of 68
`
`US 6,398,727 B1
`
`OO)
`
`FALSE
`
`2)
`
`
`
`CAL FLAG SET?
`
`AND ALERT NOT
`
`PENDING? AND
`PRESCRIPTION
`
`IN FORCE?
`
`TRUE
`
`FIG. 15C
`
`
`
`738
`
`
`HEARTRATE>
`PRESCRIPTION
`
`742
`LOW LIMIT?
`
`
`SET FLAG,
`
`
`SET TIMER TO
`
`
`PRESCRIPTION
` FALSE
`
`DURATION
`
`RESET FLAG
`
`748
`
`
`
`
`
`HEART RATE<
`
`PRESCRIPTION
`LOW LIMIT?
`SET FLAG,
`
`
`SET TIMER TO
`
`
`PRESCRIPTION
`FALSE
`DURATION
`
`
`750
`
`RESET FLAG
`
`760
`
`
`
`SET HEART RATE
`LOW ALARM
`
`50
`
`50
`
`

`

`U.S. Patent
`
`Jun. 4, 2002
`
`Sheet 49 of 68
`
`US 6,398,727 BI
`
`NOlidldoS3uYd
`OLYSWILLAS
`WavT¥HOIH
`NOILVYNG
`‘OV1dLs
`cOdS.LAS
`
`992
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`QS}Sls
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`
`ELIAMOT
`
`>Z2O0dS
`
`51
`
`51
`
`
`
`
`
`
`
`

`

`U.S. Patent
`
`Jun. 4, 2002
`
`Sheet 50 of 68
`
`US 6,398,727 BI
`
`908
`
`‘OV1d13S
`
`LaSay YAWSZITVILUNI
`
`008
`
`dS3u
`
`NOT1SISU3d
`QNOOLYSTV
`
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`JLVdHLVSdSLVINOTWO
`
`zig|SVsLassY
`
`INJYYNDLSOWFYOLS
`WHLMOSTVHLIAS
`JASW001ANSAZ
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`.OaYSLVY,OLN!
`.LuaTYLASTY|
`USWIL
`‘d0O7MSW
`édJdOQV31
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`
`V9l‘Sls
`
`
`
`52
`
`52
`
`
`
`
`
`
`
`

`

`U.S. Patent
`
`Jun. 4, 2002
`
`Sheet 51 of 68
`
`US 6,398,727 BI
`
`NOLLdMOSaud
`
`an928
`
`‘OW13S
`
`HOIH138TPSSL
`
`as4
`
`MAWL3S34
`
`
`
`NOILVUNG13S|soqy4ySHOIHdS3YSnALVeLNSYYEND
`NOUSYaWIL{13sOvidwetets
`
`08828Kany
`
`WYTV{0FuIdxa‘ovLasau
`
`gd9bSls
`
`
`
`JLVaLNSYYND
`
`d0SNINYAL30
`
`dS3uNIOSd
`
`
`
`ONILSSLSWUVIV
`
`53
`
`53
`
`
`
`
`

`

`U.S. Patent
`
`Jun.4, 2002
`
`Sheet 52 of 68
`
`US 6,398,727 B1
`
`FIG. 16C
`
`*
`
`CURRENT RATE
`LOWER THAN
`LOW LIMIT?
`
`
`
`838
`
`SET FLAG,
`SET DURATION
`TIMER FROM
`PRESCRIPTION
`
`
`RESET FLAG,
`RESET TIMER
`
`
`
`846
`
`TRUE
`
`FALSE
`
`850
`SET FLAG
`INITIALIZE TIMER
`956|RESET TIMER
`RESET FLAG
`
`848
`
`FALSE
`
`
`
`
`
` 858|RESET ALERT
`
`ALERT COND
`
`PERSIST LONG
`
`SET RESP ALERT
`
`THEN 10 SEC?
`
`
`54
`
`54
`
`

`

`U.S. Patent
`
`Jun. 4, 2002
`
`Sheet 53 of 68
`
`US 6,398,727 BI
`
`
`
`WowsYSWIL
`
`NOWdidyOSaud
`
`
`
`LOLLNSYYND
`
`
`
`NVHLYSLVSu9
`
`éLIWNHOIH
`
`HOIHLas
`
`WYVTV
`
`
`
`‘OW1dL3S3Y
`
`
`
`YAWILLASTY
`
`G9l
`JIA
`
`098
`
`
`
`SLVINDTWONSHL
`
`
`
`FOVYSAVGSLHOIM
`
`
`
`CONIONSdLYATY
`
`NOLdldOSSudVSICNV
`
`éLNAYYND
`
`55
`
`
`
`
`
`LOLINSYYNDSLVINOTWO
`
`55
`
`
`
`
`

`

`U.S. Patent
`
`Jun.4, 2002
`
`Sheet 54 of 68
`
`US 6,398,727 B1
`
`FIG. 16E
`
`
`
`876
`
`CURRENT TCT
`LOWER THAN
`
`LOW LIMIT?
`
`
`
`TIMER FROM
`PRESCRIPTION
`
`
` RESET FLAG,
`RESET TIMER
`
`
`
`END OF LOOP
`
`
`
`56
`
`56
`
`

`

`U.S. Patent
`
`Jun. 4, 2002
`
`Sheet 55 of 68
`
`US 6,398,727 B1
`
`
`
`FIG. 17A
`
`
`
`
`DETERMINED
`FROM STATUS
`
`
`GO TO
`UNFORCED
`
`RUN MODE
`
`
`FORCED TO
`
`FORCEDTO
`
`
`
`
`
`FORCED TO
`ALARM MODE?
`
`
`
`GO TO END
`OF LOOP
`
`
`FORCED TO
`
`EVENT MODE?
`
`
`
`GO TO FORCED EVENT
`MODE UNTIL EVENT
`TIME OUT. RETURN TO
`
`UNFORCED RUN MODE
`
`o7
`
`57
`
`

`

`US 6,398,727 BI
`
`QN3OL09
`
` d00140
`
`C0!
`
`OLO09ONYLYSTVaS
`
`
`
`ONISSSOONdSCOW310!
`
`U.S. Patent
`
`Jun. 4, 2002
`
`Sheet 56 of 68
`
`9201
`
`
`
`ONISSSOOUdSOON
`
`WYVTYOL09
`
`qZ)Sls
`
`LN3AAOLOD
`
`
`
`ONISSSOOUdSCON
`
`Lua
`
`LONIGNSd
`
`58
`
`
`
`
`
`SATEVLNOLLdIYOSSYdHOAHO
`
`58
`
`
`
`
`
`
`

`

`U.S. Patent
`
`Jun. 4, 2002
`
`Sheet 57 of 68
`
`US 6,398,727 B1
`
`
`
`FIG. 17C
`
`1042
`
`
`
`ISA
`GOTO
`PRESCRIPTION
`IDLE MODE
`
`ACTIVE?
`
`PROCESSING
`
`
`
`
`REMAININ
`
`RUN MODE
`
`
`RUN / HOLD
`SWITCH
`DEPRESSED?
`
`
`
`
`
`
`
`
`
`SWITCHES
`DEPRESSED?
`
`QUEUE TO
`MESSAGE TASK
`
`1054
`
`GO TO END
`OF LOOP
`
`4060
`
`IDLE MODE ~
`PROCESSING
`
`1062
`
`ALREADYIN
`IDLE MODE?
`
`TRUE
`
`
`
`
`
`
`1064
`
`SET MODE TO
`IDLE MODE
`
`1068
`
`RECORD ON RECORD
`TO FLASH
`
`
`
`59
`
`59
`
`

`

`U.S. Patent
`
`Jun.4, 2002
`
`Sheet 58 of 68
`
`US 6,398,727 B1
`
`1072
`
`1074
`
`FIG. 17D
`
`TRUE
`
` ALREADYIN
`
`
`FALSE
`
`EVENT MODE?
`
`1078
`
`WRITE 60 RECORDS FROM
`FIFO TO FLASH
`
`SET MODE TO
`1080|ALARM MODE
`
`
`
`INSTRUCT MEM TASK TO WRITE CURRENT]
`REAL TIME RECORD TO FLASH
`
`1082
`
`1084
`
`RUN / HOLD
`
`SWITCH TRUE||_QUEUETO
`
`
`MESSAGE TASK
`. DEPRESSED?
`
`1086
`
`1088
`
`VOLUMN
`
`SWITCHES
`DEPRESSED?
`
`
` QUEUE TO
`MESSAGE TASK
`
`
`GOTOEND 1090
`OF LOOP
`
`60
`
`60
`
`

`

`U.S. Patent
`
`Jun.4, 2002
`
`Sheet 59 of 68
`
`US 6,398,727 B1
`
`FIG. 17E
`
`
`
`
`FALSE
`PRESCRIPTION
`IN FORCE?
`
`
`USE 5 SECONDS FOR
`EVENT DURATION
`
`
`
`
`1106
`
`SET TIMER TO
`PRESCRIPTION DURATION
`
`61
`
`61
`
`

`

`U.S. Patent
`
`Jun.4, 2002
`
`Sheet 60 of 68
`
`US 6,398,727 B1
`
`FIG. 17F
`
`SET TO RECORD CURRENT
`RECORD TO FLASH
`
`SWITCH
`DEPRESSED?
`
`QUEUE TO
`MESSAGE TASK
`
`MESSAGE TASK
`
`SWITCHES
`DEPRESSED?
`
`QUEUE TO
`
`62
`
`62
`
`

`

`U.S. Patent
`
`Jun.4, 2002
`
`Sheet 61 of 68
`
`US 6,398,727 B1
`
`FIG. 18A
`
`900
`
`TASK LOOP BEGINS
`
`902
`
`EXECUTES ONCE EVERY 50 MSEC
`
`TASK SUSPEND 50 MSEC
`
`904
`
`
`
`BACKLIGHT
`TIMER
`EXPIRED?
`
`TRUE
`
`906
`
`TURN OFF BACKLIGHT
`
`FALSE
`
`
`
`PERFORM 4x4 MATRIX SCAN,
`
`COLLECT MAPPING INTO ONE
`
`
`16 BIT PARAMETER CALLED
`"KEY DEPRESSED"
`
`
`-
`910
`
`
`
`908
`
`DEBOUNCE THE KEY, MUST
`BE HELD DOWN > 50 MSEC
`
`FALSE
`
`912
`
`
`KEY
`
`
`DEBOUNCED?
`
`
`
`916
`
`918
`914
`
`WASIT
`TRUE
`TRUE|BEGIN SYSTEM
`
`DEPRESSED BEFORE
`SHUTDOWN
`
`
`TRUE
`
`FALSE
`
`
`
`FALSE
`
`63
`
`63
`
`

`

`U.S. Patent
`
`Jun. 4, 2002
`
`Sheet 62 of 68
`
`US 6,398,727 B1
`
`c6
`
`03S2‘LHOITHOVE
`
`4O4YAWLLLséaasnAlddis
`SINULLHOITIOVENONYNL
`
`MdLX
`
`ISNONNILNOD
`
`¥SVLd007SIONS
`
`
`
`WALSASNID3d
`
`NMOGLOHS
`
`ANI938
`
`é¥0LNOdOwd
`
`‘SSIMSLLVETIVHOSHO
`
`
`
`JSVus‘M01slLUFTOVI
`
`XOSSIMALLVEJILYSTV
`
`881Sls
`
`64
`
`64
`
`
`
`
`
`
`

`

`U.S. Patent
`
`Jun.4, 2002
`
`Sheet 63 of 68
`
`US 6,398,727 B1
`
`FIG. 19A
`
`940
`
`TASK LOOP BEGINS
`
`TASK SUSPEND
`450 MSEC
`
`ACTIVE " RUN” LED
`
`944
`
`TRUE
`
`2 MIN
`
`904
`AUDIO
`“JRUE_| MUTE,
`
`952
`
`MUTE BUTTON
`DEPRESSED?
`
`
`FALSE
`950
`
`
`DISPLAY
`
`"EVENTIN
`
`
`
`
`EVENTIN
`PROGRESS"
`
`TOLCD FOR
`PROGRESS?
`
`
`EVENT
`
`DURATION
`
`
`
`
`956
`ACTIVATE
`DISPLAY TIME OF
`DAYTOLCD|98|-aLERT/ ALARMS"
`
`LED
`
`FALSE
`
`FALSE
`
`
`
`Ae TASK SUSPEND|958
`
`50 MSEC
`
`970
`
`50 MSEC
`LED FLASH
`
`gz»
`
`o60
`
`DEACTIVATE LED'S
`
`DEACTIVATE LED'S
`
`65
`
`65
`
`

`

`U.S. Patent
`
`Jun.4, 2002
`
`Sheet 64 of 68
`
`US 6,398,727 B1
`
`FIG. 19B
`
`
`
`FOLLOW ALARMS
`962
`
`TRUE|PROTOCOL,FIRST
`ALARM DETECTED
`PENN?
`
`
`IS DISPLAYED
`
`
`
`
`
`FOLLOW ALERTS PROTOCOL,
`FIRST ALERT DETECTED
`1S DISPLAYED
`
`974
`976
`
`
`
`
`SEND BEEP,|RUE VOL UP / VOL DN
`BUTTONS
`UPDATE VOL
`
`DEPRESSED?
`
`FALSE
`
`978|TASK SUSPEND
`500 MSEC
`
`
`982
`
`
`
`VOL UP / VOL DN:
`SEND BEEP,|TRUE
`BUTTONS
`UPDATE VOL
`
`DEPRESSED?
`
`FALSE
`
`ENDOF\%4
`TASK LOOP
`
`66
`
`66
`
`

`

`U.S. Patent
`
`Jun.4, 2002
`
`Sheet 65 of 68
`
`US 6,398,727 B1
`
`FIG. 20A
`(TASKLOOP)1200
`
`1202
`
`
` FALSE
`WAIT FOR
`
`RXRDSEMA
`
`OR 50 MSEC
`
`TRUE
`
`4904
`
`
`
`
`
`
`
`CHECK CHECKSUM AND CHECK
`FOR OTHER ERRORSIN
`THE OPCODE COMMAND
`STRING
`
`1208
`4206
`FALSE[~SET ERR BUILD
`ERROR RESPONCE
`
`
`OPCODE
`
`
`BUILD ERROR
`
`RESPONDS? CS RESPONSE S
`
`
`
`67
`
`
`
`RECEIVE
`TIMEOUT?
`
`
`
`
`
`67
`
`

`

`U.S. Patent
`
`Jun.4, 2002
`
`Sheet 66 of 68
`
`US 6,398,727 B1
`
`FIG. 20B
`
`PROCESS THE OPCODE
`(GO TO SPECIFIC OPCODE MODULE)
`
`FALSE
`
` 1222
`1224
` PROCESS
`
`RETURNED
`
`NORMALLY?
`
`
`
`
`1226
`
`
`
`
`
`
`
`BUILD THE
`RESPONSE CHECKSUM
`
`
`HAND RESPONCE BUFFER
`OFF TO UART
`TRANSMIT ISR
`
`1228
`
`GO TO END OF TASK LOOP
`
`1230
`
`68
`
`68
`
`

`

`U.S. Patent
`
`Jun.4, 2002
`
`Sheet 67 of 68
`
`US 6,398,727 B1
`
`FIG. 20C
`
`@)
`
`)
`
`1232
`
`
`
`ANOTHER CMD
`BLOCK CHAR BEEN
`
`
`
`RECEIVED BY THE
`?
`MAXIMUM TIME BETWEEN
`RECISR?
`CHARACTERSIS 75 MSEC
`
`4234
`
`TRUE
`
`RESET TIME-
`BETWEEN-
`CHAR TIMER
`
`1238
`
`WE HAVE
`
`
`TRUE
`
`
`A CORRUPTED
`CHAR TIMER
`
`
`COMMANDSTRING,
`ELAPSED?
`
`PROCESSIT
`
`1236
`
`1240
`
`SET TIMEOUT
`TIMER SET
`TIMEOUT FLAG
`
`FALSE
`
`WAIT FOR 1 SEC
`
`FALSE
`
`
`EXPIRED?
`TIMEOUT TIMER
`
`
`TRUE
`
`RESET TIMEOUT FLAG
`
`1
`
`246
`
`LOOP ENDS
`
`1248
`
`69
`
`

`

`U.S. Patent
`
`Jun.4, 2002
`
`Sheet 68 of 68
`
`US 6,398,727 B1
`
`FIG. 21A
`
`=~2322 324
`
`
`
`216
`
`320
`
` C™N
`
`SL
`
`2
`
`
`
`penerebeee
`
`( Sf
`329
`ZTLLLLNEDDLLOE 338
`
`
`
`(| ~~ 0——<—+]332 {oRSSSASAEAYSSSSESSSS =
`a=
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`[———————
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`US 6,398,727 B1
`
`1
`METHOD AND APPARATUS FOR
`PROVIDING PATIENT CARE
`
`BACKGROUND OF THE INVENTION
`
`This invention relates generally to a management system
`and a method of providing patient care in the home or
`alternate care setting, i.e., to a system which functions as a
`virtual hospital room.
`A hospital room is a place where a patient can receive
`medical
`treatment and have his physiological condition
`monitored under the supervision of a healthcare professional
`both continuously and at prescribed times. As the cost of
`health care increases, the trend is to discharge the patient
`from the hospital earlier, but to continue the therapy at the
`paticnt’s home or at an alternative care facility. Various
`medical devices, such as infusion pumps and respirators,
`allow the patient
`to receive therapy outside the hospital
`environment. In manyinstances the caregiver must visit the
`patient’s home to monitor and control the medical device.
`Some medical devices, however, include meansfor enabling
`the caregiver (or healthca