United States Patent \l9]
`Goodman
`
`[54] METHOD AND AI'I'AIIATUS FOR A
`I'ERSONAL H1(Ar:rH NF:rWORK
`
`17.1 1 Invenlor: Unvid It: (;oodman , San Francisco,
`Ca lir.
`
`[73]
`
`As."ign~~: I.ifcMastcrs Supported SclfClIrc, So.
`San Francisco
`
`[21]
`
`App!. Nu.: 978,892
`
`[22 1
`
`Filed:
`
`Nov. 26, (991
`
`Related U.S. Applklltion Datu
`
`[()31
`
`Continuation of Sel". No. 518,783, Aug. 24, 1995, aban(cid:173)
`doned, whic h i.~ a contin uation-in-part of Sec. No. 334,936 ,
`Nov. 7, 1994, abandoned.
`
`Jut. CI.'
`151[
`[.12] U.S. CI. ..
`l58] Field of Scnrch
`
`...... A6IN 5/04
`600/300
`.. 600/300, 301,
`600/.129, 128/920-92.1
`
`[56)
`
`Refcrcncl'S Citl'<l
`
`U.S. P!(I'ENT DOCUMENTS
`
`7/ 1976 Slambuk .
`3,968,90n
`3,')')1 ,90H
`11 / 1976 Tholll:ls ct al.
`4/J 977 John ~o n cI al.
`4,0l8,3;'iR
`7/ 1!J77 Glover.
`4,[JJ4.7:;7
`9/1977 Bennell, Jr . .
`4.047,6.~;'i
`4,054,343 10/ 1977 IIcyland .
`4,057, 145
`lJ / 1977 Wray ct :11 .
`5/1'.J79 Gro:c;snlC .
`4, 155,0:13
`9! 1!)8(J C<I1"[ S01l •
`4,223,80)
`J/19HI Poore.
`4,254,R71
`4/1981 Krehs.
`4.26\,46R
`4,293,845 10/ 198 1 Villa-Real .
`4,295,664 1011981 Cutting.
`4,310, 10.1
`1/ 1982 Re illy, Jr. ct OIl ..
`J /t9S2 Kl'rpc .
`4.318,477
`7/1982 Fischer.
`4,340,14 1
`4,Yll ,4()S
`J 1/ 19R2 Wirtsehnfrcr .
`5/1983 Maehaillcr.
`4,382,688
`<>/1983 Villa·Rc.11 .
`4,405,045
`4,41 2,63 1 11 /1983 Hake r .
`5/ 1984 Wirlschaftcr .
`4,448,54 1
`9/1934 Murtin.
`4,473.156
`
`111111111111111111111111111111111111111111111111111111111111111111111111111
`US0058271ROA
`[It] "atent Number:
`14.1 1 J)ate of Patent:
`
`5,827,180
`Oct. 27, 1998
`
`4,473,884
`4,4YO,711
`4,504, 1.')3
`4,526,474
`4,533,346
`4,573,606
`4,588,303
`4,5%,558
`4,CJ!6,316
`
`9/1984 Beh[,
`12/19H4 JohnMon.
`3/1985 Schollmcyer c( al.
`7/1985 Simon.
`8/1<)85 Cmigrovc, Jr. et OI l.
`31t986 !,cwi:c; cl 01.
`5/ 1986 Wirtschaftcr ct .:II.
`6/1986 Sm ith ct .:II. .
`1O/ 198CJ Hnnpctcr ct .:II. ,
`
`(List continued on next page.)
`
`Primary Fxamillcr-John P. I.a9k
`Am's/(lnl 1c;.'({llIliller-""amuci Gi tber l
`Allomey, Agent, or nrm--Orrick, Herringto n & SutcJifi'c.
`LLP
`[57)
`
`AIISTl{ACT
`
`A method and system I<lr iI health network l.'omprising iI
`fa c ility, operated by a party other than the patient or health
`care provider. for co llcct ing and rOllting informat ion per(cid:173)
`taining 10 the he alth l:are of a patient to the patient and the
`health care provid er. Tbe health network "Utilize~ two·way
`commllnic:ltion between the patient and the fac ility, and the
`hca lth care provider and lhe raei lity. ln Olle embodiment, the
`fac ility receives treatment instructions from Ihe hea lth CM';
`provider that ;In') sJlecifically tk:ve [opcu ror each pati<.:nt.
`Algorithms arc ckvclopcd based on such instructions. The
`algorit hms arc then programmed into an nppropriatcly co n·
`figu red messagc dcv i(..'t; in the p05..<;cssion of Ihe patient. The
`l>a lient is promplcd b)' the me5..<;age device to mcasure a nd
`c ntcr rclevant physio log ical data, c.g., peak now, etc., as
`dictated by the tn.:a tment instnlctions. Based on the mC11-
`-"ured physiologica l data and the algorithm, messages arc
`displayed on the message device advising the patient of a
`specific eourse o f treatme nt, c.g., to adminisler medicine, 10
`ca ll the he.dlh care provider, to go to the cmergem:y room,
`etc., or, allernalivcly, such messages can provide more
`genera l informat io n related to the patient's current ht:alth
`status. These rt:sults can be transmill ed to thc facility and the
`health care proviucr. The algorithm con be modified, as
`approprialu, 10 relket cha nges in the tr(';atment plan.
`
`25 Clnitns, 7 Drawing Sheets
`
`3
`r---L--
`I
`THIRD
`:
`PARTY
`I
`FACI LITY
`: 34
`
`4
`.-- - - _1_ - - 1
`,
`,
`fT'--'--"--I 40
`'
`HOST
`I
`1 COMPUTER 1
`-
`1
`1
`1 ___ __ _
`1 HEALTH CARE !
`~ _P_R.9ylp~R_ ~
`
`J
`
`30
`
`20
`
`10
`
`Cardiocom Ex. 1003
`CARDIOCOM EXH 1040
`CARDIOCOM v. BOSCH IPR2013-00451
`
`1
`
`

`

`5,827,lSO
`P:lg~ 2
`
`U.S. PArENT IJOC:UMUNTS
`
`10/ 19.%
`4,6 17,557
`Go rtl~iI.
`4,627,225 12!J986 Faller ct ;11.
`4/1987 Wiguda.
`4,655,026
`4/1 987 Simon.
`4,660,99L
`51l9~7 Wolf t-t :11.
`4,(j(;2,S]7
`5/1987 S himizu cI .. I. .
`4,664,289
`5/J!J87 Fraziu d .. I.
`4,(i()7,845
`8/ 1987 Ringer cl al.
`4,685 .. 271
`9/1987 Rillingcr ct al.
`4,69J/i57
`9/ 19Kl M •• lpass .
`4,693,37 1
`4,695,1)54
`9/1987 Rose cl a l ..
`1/19&"1 McLa ugh lin.
`4,717P12
`2/ 1 9&~ iJrquit'Hl ct a!.
`4,725,997
`3/ 198S Sheehan ct <11. .
`4,7.10,8-t<i
`4,7J(.,&49
`I ..... o na rd cI al.
`4/ 19&'i
`S/ 198S Ston,· .
`4,74 7,514
`5/ 1 9&~ UUlllh :w .
`4,748,600
`4, 7(i·V~1O SW)S.~ Christia nsen.
`8/l9RB "iIMo.yk .
`4,766,542
`4,779,759 10/1 988 St av,'y .
`11 /1 !JS8 M(lllldillg. J r. c t ;d.
`4,781,6')6
`Il!FJ&'i MtLmghlin.
`4,7S5,%9
`4 .. 790, 118 12/19H..'i Chilcoalc .
`4,792,~B 1 2t1~J&,-! Killik .. .
`2/ 1989 Wcllerl in.
`4.R05,811
`4,807,757
`2/ 1989 Rapp:l("XHI ct al.
`.1/ J9W) 1 ~1111hcrl .
`4.81.::;,767
`4.8 1'),352
`·1/ 1989 MalllUlIld .
`S/lmN Sieg;d d al. .
`4,8.14,.264
`6/ 1989 J .\lck"lc.ld .
`4,8J8,453
`4,S()9.3n
`9/ 1989 Mou illing.
`.1/1990 Ibrlcll ct .11. .
`4.905,S66
`4/ 1990 Tump .
`4.9 15,256
`7/ 1990 Ham ilton ct .d.
`4/).19,705
`7/ 1 cy)O Mclnt\ls h c\ ;;It.
`4,942.544
`
`364/413.02 X
`
`4/)53,745
`IJ/19!X) RuwictL, Jr ..
`IJ!J()(XI Zambn cl .11. .
`4/)55,371
`4,97 1,22 1 11/ 19<JO U((Juharl d il l.
`4,975,842 12/1990 !Janow cI al.
`4,97S,:nS 1']J 1990 Arthu r, 1II .
`J/19()L Doull .
`4,I)QS,62.1
`5/ 1991 Wick .
`5,014,851
`5/ 1991 Md ... '1ughlin CI al. .
`5,014.875
`51! 991 Sei fels cl ,II. .
`5,016,230
`6J l 99L Dcsscrt inc .
`5,020,527
`5,053.032 1O/19QI Barday ct al.
`5,004,07 1 11/1991 Kcrrool, Jr ..
`1/I!)1J2 Ro mi~.: k .
`5,cJ.~2, 113
`1/1 !)92 Bunin .
`5,082,114
`5,09<>,463
`l.lo)ld ct a!.
`J/ 1992
`8/1992 Kau fm an ct ill. .......... .... JM/4 IJ .02 X
`5, 142,434
`lfJ/ 14)1)2 ~priugcr .
`5,1 52,422
`5, 154,2%
`lOll 092 Cutl e r .
`to/ tW2 B:U· kll ('f.
`5, 1."7,640
`5, 163,559 11/ 19<>2 Bunin .
`1/ 1993 Shaw.
`5,176,285
`1/1 993 Ilafncl .
`5, IRI,189
`611 W] I:ine c t a!.
`5.215,079
`6/lQ93 S himiz u c ( al. .
`5,?:I Q,mS
`(";l cJ()3 Camphdl.
`5.221.024
`,<;,2';; 1,757 WI 1 "OJ Rel yea cl :11. .
`11 / 19lJ3 Bennetl .
`5,2S9,5 31
`I 1/1 ()'I) Williams .
`5,?:('J,59(i
`S, 2S4. 1 ~; 21 1 9~ Burns cl al.
`'211994
`."i;,uU»)58
`!labcl d at.
`'1/1 !)94 Brown .
`."i , :~fJi,2 (J3
`5/1 ()f)4 Bitner c/ a l.
`\.1 I O.OW
`8/199-1 Fujimolo .. .....
`5,.1."\9,S21
`2/1995 Kirk CI a l.
`5,.'90,238
`5,542.420 M! I C)lJ6 nold1l1a n cl .11.
`
`12M,IlJOJ
`3fic1i4 13.04
`...... 128/630
`
`.. 361\/'Il3 .04 X
`
`2
`
`

`

`u.s. Patent
`
`Oct. 27, 1998
`
`Sheet 1 of 7
`
`5,827,180
`
`4
`~---l.---,
`~ , ,
`I
`40
`I
`I
`I
`'HEALTH CA REI
`, PROVIDE
`R I
`
`_
`
`_ __
`
`FIG. 1
`
`L _
`
`_
`
`1
`".
`
`3
`, ___ i __ _
`,
`THIRD
`:
`,
`PARTY
`,
`,
`: FACILITY
`'34
`)J HOST
`\
`,
`,
`,
`30 COMPUTERfT
`,- --- ---"
`
`31~
`
`2
`,-----"-- - - - - - - - ---~ ,
`,
`MESSAGE
`f..1.-10
`MICRO·
`~ , DEVICE
`20
`PROCESSOR:
`,
`,
`,
`I
`,
`I 23l
`,
`PATIENT NODE'
`I
`_ __ I
`L ___ _ _________ _
`
`_
`
`20
`".
`
`FIG. 2
`
`22--0
`
`24
`
`3
`
`

`

`u.s. Patent
`
`Oct. 27, 199H
`
`Sheet 2 of 7
`
`5,827,180
`
`<f\
`
`1~0 110~ PHONE/MODEM
`SWITCH
`
`1)0
`
`TELEPHONE
`
`MODEM
`
`FIG.2A
`
`1~0 I
`
`CHARGER
`
`I
`
`140
`
`I
`
`--I
`
`liP
`I
`r MEMORy-I
`" 152
`DOCK/CRADLE
`
`15"l
`
`MEMORY
`
`,
`
`DATA
`PORT
`
`f-.
`180
`
`- 1
`- - - -
`- - - - - - - - -
`-
`1 HEALTH CARE FACILITY 1
`1
`1
`COMMUNICATIONS
`1
`1
`PORT
`5~1
`1
`1
`1
`50
`1
`1
`1
`1 54
`1_ -_ - _ _ -
`53~
`
`PHN
`1
`\.
`
`--- -
`,- -- -- - ---- --- - - - 1
`1
`HOST COMPUTER
`1
`3....--J
`3Q
`1
`1
`:!!:!I~~ ~~R!::' ~_C~L~T\' ____ ~
`2
`_________ J _____ 31~~--,
`
`MESSAGE
`DEVICE
`20
`
`1
`1
`:
`
`DATA
`PROCESSOR
`
`1
`I
`1
`10
`1
`MEMORY
`1
`. - ._._-- 1
`23
`1 _ _ _ _ __ _ _ __ ___ ~!I.~t:!~~O~~ _ _ ~
`
`-
`
`-
`3( :
`
`r -
`
`-
`
`- - - - - - - - - - ,
`
`:
`
`40
`
`I
`1
`1 PRIMARY HEALTH
`:
`CARE PROVIDER
`- - -1- - - - - - - - __ I
`4
`
`1
`1
`1
`1
`1
`
`FIG.3
`
`4
`
`

`

`U.S. Patent
`
`Oct. 27, 1998
`
`Sheet 3 of 7
`
`5,827,180
`
`3 ___ i ______ _ ,
`
`HOST
`COMPUTER
`30
`
`1
`1
`1
`1
`1
`I
`1
`I
`I
`I
`1
`1
`1
`1
`I
`I
`THIRD PAR11'
`I
`I
`FACILITY
`I
`1
`I
`~ _ _ __ _ _ __ _ _ J
`
`2
`-- - ~- - -- - - -
`PAGING
`DEVICE
`61
`
`PATIENT NODE
`
`I
`1
`I
`I
`1
`I
`:
`
`WIRELESS
`CARRIER
`pO
`
`FIG.4a
`
`61 '
`
`55
`
`62
`
`64
`
`FIG.4b
`
`~_--L-_~ TIME/DATE
`65 ~ ANTENNAE
`
`~ ,
`
`31 ~
`
`2
`- --- - -------- ~ ---- - -- - -- - ---- - - - - - I
`MESSAGE DEVICE
`DATA PROCESSOR
`20
`10
`
`71 ~
`
`FIG. 5
`
`[
`
`I
`MEMORY
`23
`
`I
`1
`I
`1
`I
`1
`I
`I
`MEDICAL DEVI CE ]
`I
`70
`I
`I
`PATIENT NODE
`I _ _ _ ___ --- - - -- - - - - - -- -- -- -- - --- - - --~
`
`5
`
`

`

`U.S. Patent
`
`Oct. 27, 1998
`
`Slice! 4 of 7
`
`5,827,180
`
`1
`\.
`
`5----1
`I
`1
`
`COMMUNICATIONS
`PORT
`50
`
`o
`
`-
`
`I
`I
`
`1
`J
`
`54
`
`I
`
`4
`
`r- __L __
`
`I
`I
`PRIMARY
`I
`I HEALTHCARE
`PROVIDER
`I
`I
`40
`1
`1 -
`
`0-
`
`-I
`I
`I
`I
`I
`1
`I
`I
`1
`
`58
`3
`_1 __
`
`1
`I
`I
`I NURSE
`I
`I
`I
`I
`I
`I
`L _
`
`80
`
`53~
`- - -- - - -- - - -
`~3
`
`-
`
`-"1
`I
`I
`
`3~
`
`HOST
`COMPUTER
`30
`
`I
`I
`I
`1
`I
`1
`I
`
`THIRD
`PARTY
`FACILITY
`_ -- -- - -- - -- -
`- - -
`82 ----- --------i- r -- 1
`r--
`
`I(cid:173)
`I
`I
`I
`I
`I
`I
`_
`
`1
`MESSAGE
`I
`DEVICE
`I
`I
`20
`I
`PATIENT NODE
`I
`_ ____ _ __ , _________ J
`
`DATA
`PROCESSOR
`10
`
`~4
`FIG.6
`
`2
`
`3
`r---- ~ ----I
`I
`THIRD
`I
`PARTY
`I
`I
`FACILITY
`I
`I
`HOST
`I
`: COMPUTER
`30
`I
`
`I
`I
`: 3\
`I
`-
`
`FIG. 7
`
`(
`
`9
`
`~ - - - - - - - - ~ ~;~P~~;R- - - ~ - -P~~;~A~~~T~;A~-:
`l FILLlNG
`CILITY I
`
`I
`I
`I
`
`:1
`
`91
`-
`
`I-
`
`DISPENSING
`AND TRACKING
`
`FOA
`
`9
`f-.
`
`I
`I
`DISPENSING MEMORY I
`- I--
`PACKAGE
`I
`1
`96
`95
`I
`I
`-
`I
`I
`l _ _ __ _ _ _ _ _ _______ _ _ _ __ __ J
`
`I
`I
`I
`I:
`
`2
`- - - - - - -\- - - - - - - r - ~
`PATIENT NODE
`I
`-
`-
`- --
`-
`I
`MESSAGE _
`DATA
`: -
`DEVICE
`PROCESSOR I
`20
`10
`I
`_ __ ---' I
`
`'-- -
`
`' - -_ __ - ' L _
`
`~ - - -- -- -
`
`6
`
`

`

`U.S. Patent
`
`Oct. 27, 1998
`
`Sheet 5 of 7
`
`5,827,180
`
`95
`'\.
`
`97
`/1
`-
`'" -
`,.. - - ( J
`1 - _ .......
`-
`- ? r
`,.. - - (
`,- - ........
`)
`
`97
`
`FIG. 8
`
`FIG. 9
`
`100
`
`7
`
`

`

`U.S. Patent
`
`Oct. 27, 199!1
`
`Sheet 6 of 7
`
`5,827,180
`
`120
`
`IS IT
`gAM?
`
`YES
`
`122
`
`PROMPT PATIENT TO
`CHECK AND ENTER 1<---
`PEAK FLOW
`
`136
`
`-----1
`
`WAIT 30
`MINUTES
`
`126
`
`128
`
`124
`
`DISPLAY
`IS
`PEAK FLOW YES "NO ACTION
`> 80% ?
`REQUIRED"
`
`NO
`
`130
`
`IS
`PEAK FLOW
`> 50%?
`
`NO
`
`138
`
`DISPLAY
`"ALBUTEROL
`4 PUFFS"
`
`132
`YES
`
`FIRST
`TIMEs
`80% ?
`
`NO
`
`END
`SEQUENCE
`
`134
`
`YES
`
`DISPLAY
`"ALBUTEROL
`3 PUFFS"
`
`140
`
`DISPLAY
`"CALL PRIMARY
`PROVIDER"
`
`FIG.10A
`
`8
`
`

`

`u.s. Patent
`
`Oct. 27, 1998
`
`Sheet 7 of 7
`
`5,827,180
`
`174
`NO
`
`150
`
`IS IT
`7AMOR
`5 PM?
`
`YES
`
`NO
`
`176
`
`ISIT
`9AMOR
`6PM?
`
`YES DISPLAY "AZMACORT
`2 PUFFS. WASH
`MOUTH WHEN DONE"
`
`152
`
`PROMPT PATIENT TO
`CHECK AND ENTER
`PEAK FLOW
`
`154
`IS
`PEAK FLOW YES
`> 70%?
`
`160
`
`NO
`
`NO
`
`170
`
`DISPLAY
`"ALBUTEROL
`4 PUFFS"
`
`172
`
`DISPLAY "GO TO
`THE EMERGENCY
`ROOM"
`
`156
`
`DISPLAY
`"NO ACTION
`REQUIRED"
`
`162
`
`158
`
`END
`SEQUENCE
`
`164
`
`WAIT 15
`MINUTES
`
`166
`
`PROMPT PATIENT
`TO CHECK AND
`ENTER PEAK FLOW
`
`168
`
`DISPLAY "CALL
`PRIMARY PROVIDER"
`
`FIG. 108
`
`9
`
`

`

`5,827,180
`
`1
`MlcTIIOJ) AN]) Al'l'AIWrUS I,'OR A
`1'lmSONAL HIiA[;l'H NETWORK
`
`This application is a continuation of application Ser. No.
`O~/5 IR.7SJ likd nn Aug. 21, 1995 which is a continuation
`in pa ri of Ser. No. 08/334,936, Jiled Nov. 7, 1994 now
`aba ndoncd.
`
`HELD OF TilE INVENTION
`
`'jhc invention reiall:s to a system , methods and apparatus
`rPf monitoring a llcrson's hcahh, and more pnrti!.;u!arly 10 a
`comprr;hcnsivc p<lliclll management system.
`
`BACKGROUND Oll TilE INVENTION
`
`2
`rated in the cap of (I mechanized medication c()Otainer. 'llle
`cap of the eontaincr may only be opened when the prompt(cid:173)
`ing s ignal is present. Removal of the cap produces a resct
`signaltcfminating the prompt. A ctlUllI(.;r COllllts tlte number
`of times the reset signal is ge nerated, providing a compli(cid:173)
`,lflCe record.
`u.s. Pal. No. 4.695,954 discloses a medical dispen<;er tur
`dispensing fTJ(;(\icatiuus to a palie.;I1t at pre.;scribcd time.;s. The
`device includes apJ1<1r.1tus for sens ing whether medication is
`III heing taken as
`it bec.:llJllCS avai lable. A mtrs ing home!
`ho~pital version bas a transmitter and antenna tbat transmits,
`in real time, patient compliance information to a nursing
`stalion, Also, sloled patient c.:ompli:llh':'; infnfll\;ltion can he
`printed out. A home version or device docs not transmit
`15 co mpliance illfonnatiull, but this information can he
`retrieved rrom ' he display on the device itselL
`U.S. P:lt. No. -1,975,S-12 discloses an eled ronic patient
`diary that allows a patie nt to electronically lo!;, tbe onset lind
`I,;lld of a Ilfc.<.;ckcted he.llth (.;venl , sll(,;h as a p:lin e pisode, and
`sUhjeclively assess some chamcteristic of the event, i.e., the
`extent of the pain. AH information is recorded in memory
`and may 1)1.: downlolldcd to an extern:! I c.:ompII1(.;f. 'Ilw d ev il..'C
`t;i\n also prompt Ihe uscr regi\rding the time and dosagl.! of
`medicatiun.
`U.S. P,11. No. 5,157,640 di-;closcs an e.;\cctwnil.: walch th,ll
`may he progr<lmmed hy direct link to <I pharm acist's host
`computer 10 store a JIledil.:atiol1 regimen. When a medicatiun
`is to Ix; laken, an alarm is sounded, and the medic.:ation and
`dosage are idcnti lied o n fhe display of the walc h. '111e watch
`is programmed by placing it in a I.:rudlc whic.:il is in com(cid:173)
`munication with the host computer.
`The prior art lidls far short of prnviding a comprehens ive
`olltpatient management system. Most prior art device~ lire
`.'5 simply directed to the compliallce issue.
`Thus there is a ne.;ed f(lr a I.:omprchcnsivc olltpatient
`management system which evaluates (."ompliance with a
`llledkatiOIl re~illlen. monitors the eilcct of the tr..;atmenl,
`alluws 2-way infl.lrm;ltioll (.;xchange between the provider
`4f) and the pa tient. ;tnd reduces Ihe physician 's burden of
`I.:losdy monitoring, ou tpatient treatment.
`
`SUMMARY OF TilE INVENTION
`The afOfelllentinlled need is Illet by a s),stelll,lllet ilods lilld
`apparatus for a perso nal he alth nc\work. In olle embodiment.
`the he:ilth network comprises :1 hnst computer whkh is in
`1.:(jIllIlHlIlit.:ation with II computer of a health 1.:;lre provider,
`and with a data processor Ihat is ill the p(lSo-;essiull of a
`p:ltienl. A message (lcvice, :dSll in the.; possession ur the
`.~ I) p:llielll, is adapted 10 sc nd da til tH, <lnd receive data rmm, the
`data processo r. The ho~t computer, whkh is operated by a
`pari}' olher than til..; patiellt or health c.1re prov ider, rUf1l.:tion:-.
`as a I.."t,;nt ra l stalio n ((Ir col1cl.:ting, analy:t.ing and n.uting d 'lt ...
`[n one ellllllldimenl, the host computer rel.:eives. from lite
`55 health l.: 'l re provider, a treatment plan Ihat is developed
`specifically fo r cad i p.lliellt. Algorithms arc llcvd(lpe<i
`h,lsed on such a pl;l11. '111e alg,orithms ;ne then programmed
`into an approprialely configured message device. The
`p .. tient is prompted hy the mess;lge device 1(1 me;L"urc and
`l:l1ter rclevililt phy."io logical d,lIa, e.g., peak now. ele. as
`dictated hy the lfeatllll.:nt pIal!. lbsed on th...:
`Ille.;a sured
`physiologit:al d'II '1 ,lOti
`thl.: i'llgorithm, mc.ssages arc d is(cid:173)
`pl'lycd 011 the tnes..sage dev ice advising Ihe p"l ienl of :1
`specific CClur.se or al.:tion, e. g., to admillisler medicine, to c.:aU
`(;5 his health c.:'I(1.: pnl'lide r, to 1;,0 to the emergency room, elc.
`'l1lesc feSU ilsGln he transmitted 10 the fac ility :1I11lthe health
`c.:a re provider. '!1l\,; algorithlll (.:,111 be rtWdiJied hy the ho.;alth
`
`Outpa tient mallilgcmc nl of c hronic disease Illa y bt.: ide,lIl y
`described ns a series of discrete tasks that arc interrelated
`and madul,lled by information flowing back 10 the prilll<lry
`health care providcr. The ckmcnls of outpalient l:arc thus
`indudc ( I) prescrihing a trt.:<llmcnt, typically drug-based; (2) 20
`a patient jmll:pendently obtaining the prescribed rnedil:ation,
`e.g., IWing a prescriptiun al it pharmacy and!or purchasing
`tlv\,;r-the-\':OUl1tef Illedil:.l tion; (3) the patient ta lking the
`medication as pre))t.:ribed; (4) monitoring the c[ects of the
`self-Illedie:lting tfeatment; anti (5) modifying the treatment 25
`based 00 pil tien t rcsponSt;.
`In the tf<ld itillnal model of outpatient rnan:lge rnent. tbe
`information interchange steps (4) and (5), critica l to suc(cid:173)
`cessrultrciltmt.!ll t programs. occur sporadicOilly. ()rtcnlimt.!s,
`till.! excballgc occurs during a follow-up visit 10 the primary .~o
`cafe provider or to :1I) emergency room or hospitaL Further,
`the inform;Itio ll
`Il()W W<lS \ypica lly one W:lY, from Ihe
`physici:lIl \(J the patient.
`More recen tly, in the era o r the patient as C(l ilsumer and
`health carl,; rdorm, Ihis s ilU alion has changed dr<lmatil.:<t ll y,
`The int'orJllilt ion lIuw is no longer sv sporadic (H one Wily,
`but the pwc.:ess of dosc1y monitoring mltpatien t treatments
`is incollvl.:nient tn b( llh tilt.! patient.". :mll health ca re provid(cid:173)
`ers. For the patient, it means numerous trips to the doctor's
`oil1ce, often for simple matters like a blood pn .. :ssure chec.:k.
`that c.:ould as e:lsily he performed at home.l'or thl.! physician,
`do:-;c monitoring is inellicient, hoth because the issues :lfC
`routine ([ud it limits the ahility to illc.:reasc Ihe Ilumlx;r of
`patients limier management. As a result, the known pro- 45
`ce!".'>Cs or o utp:lticll t mall<lgcUlcnt result in many p:d ie nls
`" r:d ling th rough the crack.s" and (.·ol\suming needles." and
`expe nsive resources ror trivial or routine foll ow-up care.
`A wide variety o f (li.:vices have been propose() to improve
`oUlpatil.:1lI management o f the chronica lly ill. Most stich
`devices an.: directed to improving patient he alth through
`inc.:reasing compliam:e with :1 medication regimen.
`u.s. Pa l. No. 4,49H.7L1 di.S<.:loscs a pwgr<lmillahle mul(cid:173)
`tiple alarm timing device. The device lIIay be programmed
`for up to a se lected number o f alarms per day. As the alarm
`is s ilefll.:cd. a counter is inl.:remenled. 'I1ms, the coun te r
`indicates how lllallY till1e~ tIll.': nscr was ,Ikrted to take his o r
`her mediCillioll. The counter I.:llll be interrogated by pushing
`:I huU(l1i OIl the devic.:e w hir.:h w ill cause the count 1(1 appear
`on an LCD included with the dcvice , A memo book is used 60
`in I.:onjunc.:tioll wilh the tililer.
`U.S. Pitl, No. 4,504,(5) disdoses a pharmac ist(cid:173)
`p rog r a 11111 \ ,I h I e! ph ys i c i it n - p mgr <I 111111 <I h Ie
`I!ll,;(\ it: a t io II
`prompting sysk:m wherein:. pharmacistidoetor inputs (I,lta
`:1 medir.:atioll sr.:hedule intn the memory of ,I
`reg,ard inl;.!
`p w mpting device which ge nc rak s a prompt ing s ig n;d
`acr.:ordiug to Ihe sdtedtile. The pronlJ1ter nw y he inc(lq}()-
`
`10
`
`

`

`5,827,180
`
`3
`care pwvidcr. iI~ approprialc. 10 rCnC~1 ch'lngcs in Ihe
`treatment plan. As a result, the mcs.-;agl,; device iocorporak:s
`a customized trcalmcnl plan thai is updal<1blc based on data
`provi(h.::d by the patient ano IlI.~a1th can.; provider.
`
`BRIEF DESCRwnON OF TilE DRAWINGS
`
`Further features II ml adVllnl agl.;s of the invention will be
`apparclllllpon ctmsidcration of the fon,going objlXls and the
`following detailed dcscriplion of prefe rred embodiments of
`the pr\,;sI.:111 inventioll, (<lken in r .... oujurl<.:linn with th(.; a<.X':Offi(cid:173)
`panying drawings, in which like rdefence nllm<;rals refer to
`like c\!.;mcnls, ,lIId in which:
`FIG . 1 s h(lwS a block sdlcmalic diagram of :t pc r.<;onal
`health network in accordance with a preferred embodiment
`of t1w prc!'>cnl invcll tiuu;
`1-'I(i. 2 shows a message dev icc of thc network of FIG . I;
`F1 (i. 2/\ stlOws it block sdwillat ic d i:lgra m of a tllcss..1.ge
`(It;vicc of the nelwork of He;. 1 in nccordatH.:c with a
`preferred emhodiment of the invention;
`FIG. 3 s hows a hluck schelllatic diagram of a personal
`bealllt network in ;lccord<lllCe with an a{le male embodiment
`of the prescnt inven tion;
`I'Hi . 40 s hnws an alternate implcme lll<llioll oj" the mes-
`sage dev ice and d<l la pro..:cs.. .. ;or (If HG. J ;
`10'[(; . 4" shows a preferreu elllllOdimetlt nf the :l lt ernate
`impit:men tatioo or the message device o f nG. 4t1;
`FI G. 5 shows ;111 :llte rnatc c mbodiment of Ihe p..:rsonal
`health network of the pn;scnt invention wherein compatible
`medical devices ("'(.l mnlltnicate with the data proct:s...;or;
`1'1(, . 6 s hows an embodiment of tbe persoll:l! health
`net work o f the prcscnt in vcnliu n which includes a case
`rnanag,er nu rse;
`!'IG. 7 shows an embodiment of the present inve ntion
`which incorporates n pharmace;utical dis pensing and tr<lck(cid:173)
`ing syslem;
`1'1(;. H shows ;In e;mbodirnent of a dispensing, p:u.;kage; of
`1,'IG.7;
`1;1<1.9 shows ;In crnbod ime;nt uf a dose inhaler ad 'lpt<.:u for 40
`usc w ilh the system of FIG . 7;
`lOa shows an algorithm bascd on an exemplary
`FIG.
`trealmcn! plan for a first asthma paticnt; and
`1:l(j. IUh s hnws an OIlgpri thlll hascd un ;t11 ..-xeIHI.la ry 45
`treatm,,111 plan fot a second ast hma pa tietl t.
`
`25
`
`IlE'I"" .EIl DESCRIPTION OF TilE
`INVENTIO N
`An ernlxld ime;nt (Ji" a person;11 health network ("PIIN") t
`of the prescnt ill Veliliutl is show in 10"1(;. L. The; I'IIN I
`comprises:lt least u ne pat ien t nocle 2, at h.:ast o ne third part y
`fac ility 3 aUlI :tl least (lne hc:dllt C; I re pnlVidt:r 4 . Each third
`party f:lcility 3 prefer:lhly int:lllde:-.:t hosl {:(J ll1 puter 30 which
`is in C(llllnntnicatillll with e;ach patient unde; 2 Ix:in g mall-
`uged by tbe faci lit y 3 owr iI communication li nk 31. The
`host (:ompu l<.:r 30 also is in communica tiotl with each health
`can: providcr ..j. for each patient 2, ove;r :1 communication
`link 34.
`E:u.:b palie;n t node 2 includes a data proce;ssor It) <l nd a
`m..:., .. ;lgl; dev ice 20. ·1111..: da til pn lcl..:s.";or lO is ill t..:{IIllIlHtIli(cid:173)
`cation with host (;Orn pltter 30 vi;1 (;omtllunicatiotl line 31 and
`is lIsed for downltlading informatiollto , and receivin g infor(cid:173)
`mat ion from, tllcs...;ag.; device 20 . The IlO.~t I.:omputa 30 is
`opmah;d hy ,I third pilrt )'. The th ird pil rt y is respo llsihk for
`tbe operatio n of the PI IN 1 alld place;metlt or the s(lftwan:
`<Ind, in certain case;s, hardware. that cOlllprise thl.l various
`
`4
`embodimcul:-; and/or compo nents of the I'IIN 1. Thc host
`computer 30 of the third p:lny facility 3 fUllcti ons as a
`central station [or COllecting information which ca n be
`<lppropri:ltely rout!.!d tll the patient 2, health care provickr 4
`5 or other iOC,1.linn, as discussed in more detail below. 11lc
`processor 10 and message de;vil,,'C 20 arc in the possession of
`a patient 2.
`For purposes of clarity only one patient node 2, <lntl third
`p'lrty facility 3, Jnd one health Care provider 4 arc illustrated
`JO in FtG. 1. lIowevcr, il s hould lx: understood Ihat the re may
`be a plurality of pati l.!t1t nodes 2 :l nd a plur:ll ily or Iwalth care
`providers 4 in communication with the; tbird party facility 3.
`Indeed, the third pa rty t:1.cility 3 rn:ly incl ude more tha n one
`such fadlity (e.g., covering dilIe;ring gl;ographic or demo-
`IS graphic areas), such that patients m:lIlag"d by one fa ci lity 3,
`can be serwd by health care provit\e;rs 4 that arc in c()m~
`mUllica lio n wilh .1 dillerent facility hascd on inle r(acility
`co mmun ications. (n this way, the PI IN 1 is cap ahk of
`managing millions of patients 2 and health care provide;rs 4
`21J by appropriate individual identification, addressing and
`tllcs.<;agi ng . which cOllllnunic atiOfl tt;cittliqtles and proto..:ois
`are; known 10 those (If ordinnry ski ll in the art.
`The mes.<;<lge dt..:vi ce 20 is <l portable device, of suitable
`s h<lJle and size to be carried in tbe; pockcl, purse; or hriefcase
`or a p;uie nl . [Jrcfcrahly, Ihe I()(tll f;tc tor and industrial de;sign
`of the message devit.:c 20 are; o ptim ized for ac..:cptauw by
`the; intemled user, including chi ldren and senior dtiz.ctl s. In
`a prcfe;rred e;tllbodime;nt. the llles.<;age devi(;e 20 is powen.:d
`by a rcc h:lrgcahk I)()wcr source;. 'lllC me;ssagc device 20
`.~o rn:eivt:s in fo rmation from the host computer 30 whe n the
`Illes.<;age device; is plucnl in e(lm munical ioo with the pro(cid:173)
`t:e;ssor 10. Preferably. the; mes.<;ngc dcvie!.! 20 and proces. .. or
`10 have (;Olllpicmc Ol:u y phys ical st ruc lltres so that o n physi(cid:173)
`c,l l cOllt:tt:t, a (;ormc<.:lion is for mcd, for (;x;un plc, vi:t m ale
`JS and km ,tlc conn(;ctors, sudl that informatio n transfer in one
`or both directions can occur. It is known to those skillcd in
`thc art how loimplc;menl sut..:h devices and the ir in tcrcon(cid:173)
`nccti(ln.
`In onc cmbodirm:nt, the me;ssage de;vi<.:t: 20 provides a
`me;dical ion alarm . A patjc;nt's en tire mcdie<ltiotl rcg imen,
`itlclud iug dos ing interva ls. ca n he; downloaded from the h(l.. ... t
`I.:ompu te;r 30 to the data proces..~or 1 0 v ia communica tion
`line 31. This information is transferred to the message;
`device 20 whell it is in t:ommttnicatiotl with thc data
`prOl.:essor 10. At the;
`:lppropriatc limes, Ihe plltie; nl is
`prompICd by audiblc or tactile <l lerts. In a preferred embodi -
`ment shown in lil(; . 2, the me~ ... agc devi<.:e 20 includes a
`large-ar!;a b<lddit 1.C I) dispJay 21 so that the mt me o f the;
`medica tio n and dru;..; tn;IY bc dis pl;lycd . ' I'he PJlj~tlt turns o lf
`so tbc alert by activ:lting a switch 22 whic h alMI causes a
`prograttHllahlt:: memory 23 to s tore the date and timc the
`sw itch Was activated . Iknce, thc me~<;ag.e unit 20 stores a
`record of the ~1- ca lJcd compl i;ull. .. oc dat it, itld ud illg tlte d;tte
`arKI time; the switch was a(;tivH ted and Ihe tll!.!dical ion and
`dosage; tlwt the patil.:nt was sclteduit:d to "Ilic. In this regard,
`if the p~lient':-; regimen is to take mOf!.! than O ilC me;dicalion
`at the; sa ml..: time, the n e.tdt othe r Illcdic:lti(ln w ill appear on
`the LeI) display. !.J.g., one at a tim e; ,tlkr the; swi tch is
`activated, e.g., in re~p() nse 10 all alarm whit:ll occurs for each
`Illedicalio n. J\llern:tlivc;ly, ml\lt iple medi ca tions lltay ;lppea r
`in thc I.CD d ispla y sllch that ;lelivating HlC switch e nters Ihe
`lime ;111<1 dale data for I..::tch ttl(;dicatilltl displaYl..:d.
`When the message (kvicc 20 is ill coJlltllunicatiotl with
`the d ata proces.<;or I O. the; compliance data can he ttploadcd
`tl) tltl; h(l~ t COll1pUlcr 30. ( ·ompl i.lIl1..:c d"t ;I Gill thl..:l1 he
`eva luatt.;d th rough ap propriate software iHld a reportlhercof
`ge;nerat(;d ,lnd lranSJI1illnlto OtiC Of both or the COlllputer 40
`
`.5~
`
`GO
`
`CIS
`
`11
`
`

`

`'.
`
`5,827,180
`
`5
`of the al>proprialc prim,lry health care proviocr 4 and IIIl:
`processor 10 of patient 2. The report may be electronica lly
`transmitted via a suitable communications port 50 owc !'IIN
`I, or printed ou paper amI mailed tn the intended n:L:ipicnt.
`In a further embodiment, the rncssngc device 20 may n.:ccivc 5
`other alarm inrormatio[} frolll [1m primary health can.: pro(cid:173)
`vider 4. Fo r cx.lInplc. patients c:m be rcmimkd about a
`s..:hcdulcd v is it ()f 10 schedule a vi:-.il.
`In a second cmb(J{limcnt of Ihl; present invention, ,.;;llOwn
`in FIl;. 3, the PIIN 1 is also in cornnllilliciltion wilh another
`health care f;lcility 5 such as it diagnostic laboratory, ,\
`pharmacy, a dillie, or a hospital, of which only one is ~hown
`for clarity. ' Illlls, in addition tn Ihe medication regime n :md
`Ol her infurmat ion frum eaeh I)rimary he.llth c<lre provider 4 .
`th.; message lu;vic.; 20 may recc.iv.; information from otll.;r
`hea lth care fa<':i[ilics 5, which is transmitted 10 host <,:ornput.;r
`30 via communications line 53 and then downloaded to the
`data processor 1 0 ilnd the messag.e dev ice 20. Throug.h s uch
`a network , palien ts 2 and doctors 4 ciln receive the resulls of
`tests pcrfonncd " I <I Inb or hO!lpi tnI5, S uch informa tion from
`the o ther h';:llth c are facilit ies 5 can :lIso be c ither dired l)"
`via cormJlunic;ttitJf] line 54, or indirectly, via the host com(cid:173)
`puter 30 through commu nication lines 53 and 34. COll1nnl(cid:173)
`nicilted to the prima ry heallh C:\I"("; provider 4. In :1ddition.
`s tatistical reports o r th.; activities or a number of patiellts call
`hc gel1craleu . S\H.:h rcporls an; o f valuc 10 hea lth t.:are
`m:magemcnt org:1niz:ltiulls .1Ild ph<lrma<.:cuti<.:a l manuf;lCl ur(cid:173)
`CfS.
`III a furth.;! embodime nt, the nH;s.~<lgc (kvicc 20 C<ln be
`enhanced 10 incorporatc two-wa y I11cs..<.;age capability whe n
`cou plcd to data p{(lces.<.;or 10. I:or cX:lmpic, by adding o ne or
`morc switches 24 (two are shown in I:}G. 2), pa!icnts ca n
`n..:s po nd 10 qu(;ry~t yp\.; 1lIc. .... ..;a~c. .... c llh;wcing th e ah ility of
`pnlv idc.rs 4 to trad the st"IUS o r their patients 12. The
`elcc1runics I.;quircd 10 provide the two-way lIleSs.1~'; c apa(cid:173)
`bility over wir,,-bascd coupling :1l1d radio freqw.:m:y hased
`t.:{)llpling arc well knowll to
`th llSC skillcd in the ar1.
`Advantngeousl y, providing, the swi tches 24 Oil mcssag,e
`dcvice 20 en~lIn;,..; Ihatthe stowd datil Can be uploaded to thc 40
`Illist uunput er. Alte rnatively. Ihe switches 24 (:ou ld hc
`Jocatcd o n p((K;C~Wr 10.
`In:1 fmtilcr ernl:x.l(Jiment of 1lH.;,<;Sllg,C device 20. softwa re
`and adapters ca n h" devclopcd S{I that persoll:1\ digiLal
`assistants, su c h as the devices model Wizard availil hle from
`S I IA RP Electronics, Inc., device ll10tlellIP ! OO! X aVilililbIc
`from IIcwlcll Pac kard, <111<1 dev ice model Newlon aV:1 il<lhle
`froml\l>plc COIllJllltcr, lnc., COl li <""(lIHmun ic':ltc with the d"til
`procc. .... ';or III to receive inli.mll:1tion from . and deliver info r(cid:173)
`mation 10, tile host compuler 30 ;lllt! to generatc th<.: aicrts for
`medication reg imen. store tbe patielll co mpliance dat a, and
`10 provide a dis play of sales info rmatioll dowlll(lad~c1 from
`data processor 1 0 !\ nu ["or two~way <.:omillunicalion wjth
`<I:lt :l I'rm.:cs. ... o r. S tamlard tl:lta I.:OIlHllIlll ic;l tiu lIS Gill h" usci!
`.lIId Ihes...: <.:;H1 hc easily ere,lled hy p..: rsuns o f ordinary !>\kiU
`in the ar\.
`In :t ["urther ellllwd iment of data pro.:essor to. a patienl(cid:173)
`a!>\ a IlI..: rsonai ctllTlpu! er (or
`OW lled comput er stIch
`workstation) or persona l digit al as.-;istanl could bc used in
`place of a dcd ic;lled data procc ..... <.;(lr. prov ided lit al the host IJI)
`co mputc f 30 is providcd a<.:<..'css to the pcrsonill C()lIIpUlcr and
`(::111 estahlis h eOIlHllllnic:lt iollS therew ith in a similar mllnncr
`ilS thc dilt,] procc!>\. ... m 10 dl;scrihcd Ilere in.
`1-"1(;. 4([ sil(lwS a further cmlxldilllcilt of the PIIN 1
`\vherein the host cOll1puler 30 i .... ill comlll11nicalinn with a (i5
`wirc ks...; carrier 60 \0 prov idc medication rcmi ndcrs and
`Illcss;lg.ing l'''pahi lit ics for t)ilticlt ts w ho own/Ic;lsc IMg ing.
`
`6
`dev ices 61. Wirclcss ca rrie r 60 thus receives instruclio ns
`(o rm hnst computer 30 to deliver parlicul<lr messages to
`spccinc patients 2 al predetermined limcs, Wireless carrier
`60 llllill "telephones" the paticnt's pager 61 in a conventional
`mann er, or under contro l of an automatic operator ami
`delivers Ihe mcssage, ac tiv(l ling the pager 6.1 al:1f1n mecha-
`n ism . '111e patient 2 then rc;sponds 10 th e pager alarm hy
`prcs.<.;.ing thc switc h. Fo r p:lg ing dcvi<.."Cs 6J hav ing 2-way
`commu nica tion . pr~ssi ng thc swi tc h C:1 0 p rov ide
`.1Il
`lO ackuowledgement of tbe message deliver~d, w hkh can be
`recorded by the wireless carrier 61
`;\ s co mpliance
`infnrllHl lio n, which inforl\l:l tioll is then cOlllmu nicated to the
`host computer 30. Thu s, the wireless c,mier 60 functions :1S
`thc d ata processor 10 and the paging device 6l pc rlorms Ih~
`15 mcs.<';'lging functions of thc mes.'iage device 20 .
`In iI preferred cmhodimcnt shown in FI(i. 41>; a mod ified
`paging device 61' i.s used which includes a non-volat ile
`meillory 62. real-time d ock 63, antenna 66 ,lIld suit:1b1c
`software 64 for slori ng a medication regillllill or other dal a
`:w withill the paging device 6.1 anu for causing a message [ 0
`appear in an alphanumeri<.: d isp la y 65 bascd o n thc nuxliea (cid:173)
`lion rcbimen or other dal :1 in the non-volillile memory 62. In
`this n.:g:1rd, medication r"lIlinders arc likely to be repeatc<.l
`daily for a period or time. Ins tead of hav ing, the wireless
`25 c:lrrier 60 scml tbe medication alert for I,;ac:h alarm, at an
`exIra cost for sending, tilc sa me message oVer :md over, the
`dock 63. soLhvarc 64 and mcmory 62 within the paging
`devi<.:c 61 '