I||||||||||||||||||||||||||||||||||l|||||||l|||||||||||||||||||||||||||||||
`
`USUO68U4558B2
`
`(12) United States Patent
`Halter et al.
`
`(10) Patent No.:
`
`(45) Date of Patent:
`
`US 6,804,558 B2
`Oct. 12, 2004
`
`(54) SYSTEM AND METHOD OF
`COMMUNICATING BETWEEN AN
`IMPLANTABLE MEDICAL DEVICE AND A
`REMOTE COMPUTER SYSTEM OR
`HEALTH CARE PROVIDER
`
`(75)
`
`Inventors: Markus Haller, Begnins (CI-I);
`Bozidar Ferek-Petrie, Zagreb (HR);
`Adrianus 1’. Donders, Founex (CH)
`
`(73)
`
`/Lssignee: Medtrtmic, Ine., Minneapolis, MN
`(US)
`
`( * } Notice:
`
`Subject to any disclaimer, the term ofthis
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 29 days.
`
`(21) Appl. No.: 09[765,4S4
`
`(22
`
`Filed:
`
`Jun. 18, 2001
`
`(65)
`
`Prior Publication Data
`US 20(i2;"fl(l82665 Al Jun. 27, 2002
`
`Related U.S. Application Data
`
`(63) Continuation of application No. 09,843,506, tiled on Jul. T,
`l(J‘)9,
`Provisional application No.
`21100.
`
`t3E};'l't'f).499, tiled on Jan. 18.
`
`(60)
`
`Int. Cl.7
`(51)
`(52) U.S. CI.
`
`(58) Field of Search
`
`A61N U362
`607,80; 607!32; M17160;
`1281903
`60Ui’30[l; 128E902,
`I29-I903, 904; 607250, 59, 30-32
`
`(56)
`
`References Cited
`U.S. P/\'l'l£N'I‘ DOCUMIENTS
`
`SIIQ95 Dempsey ct al.
`5,417,222 A "‘
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`5_.72D_.TI'{l A * H1998 Napphotz et at.
`
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`
`128i'9U3
`
`EP
`El’
`EP
`I31’
`El’
`EP
`EP
`EP
`1.7.?
`WO
`WO
`
`FOREIGN PATENT DOCUMENTS
`
`0 98? U4?
`U62 U82
`062 033
`(I62 084
`062 085
`(I62 086
`062 976
`062 980
`062 981
`WO9';';‘C|fl7I'}8
`WO99)'14882
`
`9;‘1998
`M1999
`Cir‘ 1009
`6_«’l9()9
`M19539
`6r‘l999
`(ifl‘)99
`6,5199?)
`(#1999
`U199?
`M1999
`
`OTHER PUBLICATIONS
`
`“Nokia Launches Nokia 9000 Communicator", Mar. 12,
`19973‘
`“Qualcornm merges phone, handheld”, Sep. 21, 1998.*
`Arzbaecher et al., “Automatic Tachycardia Recognition,”
`P/\(_‘tj, 541-547 {May—.lun. 1984}.
`Olson et al., “Onset and Stability for Ventricular Tach-
`yarrhythmia Detection in an Implantable Pacer—Cardiovert-
`et'—Defibrillator," Computers in Cardiology, IEEE Computer
`Society Press, 167-170 (Oct. 7-10, 1986).
`
`I’rinIar'_t' f:‘Xaitiiner——Gtxirge R. Iivanisko
`(74) Attorma}-‘, Agent, or Fi'nn—Girma Wolde-Michael;
`Daniel G. Chapik
`
`(57)
`
`ABSTRACT
`
`A medical information communication system and corre-
`sponding methods are described. The system permits moni-
`toring the performance of an implantable medical device
`(IMD) implanted within a body of a patient, monitoring the
`health of the patient, or remotely delivering a therapy to the
`patient
`through the IMD. The IMD is capable of
`bi-directional communication with El communication
`module, a mobile telephone andfor a Personal Data Assistant
`(PDA) located outside the patient’s body. The system may
`comprise the IMD,
`the communication module andtor a
`mobile telephone andfor a PDA, a remote computer system,
`and a communication system capable of bi—directional
`communication, where the communication module,
`the
`mobile telephone andfor the PDA are capable of receiving
`information from the [MD or relaying information thereto.
`
`(List continued on next page.)
`
`4 Claims, 23 Drawing Sheets
`
`s:.
`
`Zfi
`-
`_ En.
`01 win 'w
`( M ..,,l
`#5:» 3 sun: -n(-av mm
`‘~-‘*-.
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`we: .-anmnm-.5.‘ 4-was
`m .T —_-
`l
`immune,
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`I
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`Ill
`-urn: an
`‘ I
`in run neon .
`m
`._ ._._J:_ 3,, —'
`\__
`an is on nu: ma. ten
`.,.__
`an m an» —
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`-
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`
`
` |J:n’::-9v\'«IIr9'DI'|tlIIInN‘ev\'lII*.'.to'Il
`
`banana-Iron
`T_l._—_'_-
`
`SIERRA WIRELESS 1012
`SIERRA WIRELESS 1012
`
`

`
`US 6,804,558 B2
`Page 2
`
`US. PATENT DOCUMENTS
`
`5,729,771
`5,722,999
`5,749,997
`5,752,235
`5,752,976
`5,791,342
`5,899,473
`5,839,438
`5,843,139
`5,848,593
`5,855,609
`5,857,967
`5,876,351
`5,895,371
`5,912,818
`5,941,996
`5,944,659
`5,954,641
`5,971,593
`
`>I>)*>>3b>>>>>>>3h-.’;°>IP>>
`
`2.31998
`31’ 1998
`5.31998
`51" 1998
`51' 1998
`831998
`93' 1998
`1 11’ 1998
`121'] 998
`1231998
`11’ 1999
`131999
`31' 1999
`4/1999
`61’ 1999
`591999
`891999
`9,:"1999
`101’ 1999
`
`S119]!
`Snell
`Mann
`Demenus et al.
`Dufin et al.
`Woodard
`Faisandier
`Craeltinger el al.
`Goedeke et al.
`McGrady et al.
`Knapp
`Fiid el al.
`Rohdc
`Levital el al.
`McGrady el a].
`Barreras, Sr. el al.
`Flash 1?: al.
`Kehr et al.
`McGrady
`
`3*>>3*>>3P->>.’>>>}>
`
`5,974,124
`5,977,431
`5,9875 19
`5,993,046
`6,094,029
`6,996,935
`6,022,315
`6,023,345
`6,024,539
`6,925,931
`6,035,328
`6,053,887
`6,083,248
`6,117,973
`6,292,698
`6,395,377
`200110032099
`299179047125
`1309210092326
`
`1011999
`111' 1 999
`l 11' 1 999
`11.31999
`121' 1999
`12.31 999
`2320(1)
`2320(1)
`21’2000
`21’2000
`31’20(1)
`4020(1)
`'.-'.«’20CU
`9152000
`91’2001
`1092001
`1022001
`1 11’2001
`11'2002
`
`ll-1I--llflI-
`
`* cited by examiner
`
`Schlucter, Jr. et al.
`Knapp el al.
`Peifer el al.
`McG1'ady cl :1].
`Bartur
`Nabahi
`lliff
`Bloomfield
`Blomquisl
`Bloomfield
`Soukal
`Levilaze at al.
`'l‘I1ompsor1 ct al.
`Jones el al.
`Dufifin et al.
`Portwood cl al.
`Joao
`Quy
`Causey III el al.
`
`6001300
`60'1';‘32
`1231397
`705732
`.. 6001300
`6(Il1'300
`
`.
`
`
`
`

`
`U.S. Patent
`
`Oct. 12,2004
`
`Sheet 1 of 23
`
`US 6,804,558 B2
`
`

`
`U.S. Patent
`
`Oct. 12, 2004
`
`Sheet 2 of 23
`
`US 6,804,558 B2
`
`

`
`U.S. Patent
`
`S
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`
`U.S. Patent
`
`Oct. 12, 2004
`
`Sheet 4 of 23
`
`US 6,804,558 B2
`
`C3
`
`3
`
`

`
`U.S. Patent
`
`Oct. 12,2004
`
`Sheet 5 of 23
`
`US 6,804,558 B2
`
`5&8
`
`gums
`
`0000
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`U.S. Patent
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`
`U.S. Patent
`
`Oct. 12,2004
`
`Sheet 7 of 23
`
`US 6,804,558 B2
`
`
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`
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`6:13‘
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`
`

`
`U.S. Patent
`
`Oct. 12,2004
`
`Sheet 8 0f23
`
`US 6,804,558 B2
`
`Remote System
`150
`
`D010
`'
`at
`an ysls
`
`Patient
`|0CGt10i'I
`intenogofion
`
`Nearest
`physician
`dota
`
`Pqtient
`action at
`advise
`
`Patient
`
`data
`
` Comm. Moduie lUG/
`
`
`Communication
`System 120
`
`
`
`Mobile Telephone 110
`
`Patient
`monitor
`
`
`Conntection
`Di5e°5°
`Relay or store
`
`
`0
`alert scheduled
`d
`l
`
`up1oad/
`on
`re fly
`remote sewer
`patient
`
`interrogation
`
`
`
`
`
`
`Comm.
`tower
`Iocofion
`
`
`
`
`Progromrning/
`Reception
`C
`1-
`
`
`updating/remote
`of action dc
`to flrjgegoifignt
`
`interrogation
`advice
`
`
`
`
`
` Connection
`
`to physician
`
`FIG. 6C
`
`

`
`U.S. Patent
`
`0
`
`M
`
`US 6,804,558 B2
`
`31]f2:08utuE_
`
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`

`
`U.S. Patent
`
`Oct. 12, 2004
`
`Sheet 10 of 23
`
`US 6,804,558 B2
`
`Remote computer system or
`heolih core provider
`E3
`
`Communication system
`E9
`
`Mobile teiephone
`E
`
`Communication module
`
`E39.
`
`10
`
`10'
`
`10"
`
`10"’
`
`FIG. 8
`
`

`
`U.S. Patent
`
`Oct. 12, 2004
`
`Sheet 11 of 23
`
`US 6,804,558 B2
`
`201
`
`
`
`Patient 5 desires medical attention
`
`
`
` Patient initiates upload of data
`
`to comm. module 100
`
`203
`
`205
`
`IMO ‘:0 and comm module 100
`communicate. data are uploaded
`
`
`
`Comm module 100 and mobile
`207
`
`letephone 110 communicate. date are
`relayed to remote system 1.30
`
`via communication system 120
`
`
`l
`
`
`209
`
`
`Remote health care provider 136
`and/or remote computer or expert
`system review and/or analyze data
`
`
`
`211
`
`
`
`Diagnosis of patient 5 carried out b
`remote health care provider 136 and or
`remote computer or expert system 130
`
`
`
`225
`
`Comm. mod. 100
`
`and phone 110
`provide confirmation
`that remedial
`
`response has been
`carried out
`
`Remedial response
`carried out by
`IMO I0 and/or
`communication
`
`module 100/110
`
`Remedial response
`relayed to comm.
`module 100 end/or
`IMDl0 via phone 110
`
`Determined
`
`appropriate
`remedial response
`executed by
`remote health
`
`care provider 136
`ondfor remote
`computer system
`or expert system
`
`
`
`Patient 5
`
`comm. module 100 and/or
`ND 10 require further
`attention ?
`
`
`Patient 5 is
`
`sent message that
`no further medical
`
`attention is required
`
`
`
`
`217
`
`Remote health care provider 136
`and/or remote computer or expert system
`130 determines appropriate remedial response
`based on diagnosis
`
`l
`
`FIG. 913
`
`

`
`U.S. Patent
`
`Oct. 12,2004
`
`Sheet 12 of 23
`
`US 6,804,558 B2
`
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`

`
`U.S. Patent
`
`Oct. 12, 2004
`
`Sheet 13 of 23
`
`US 6,804,558 B2
`
`Patient desires
`Medical Attention
`
`Patient
`initiates
`communication by
`pressing comm. module
`100 button and starts
`communication with
`IMD 10
`
`203
`
`Comm. module 100
`
`
`
`uploads relevant
`data from MB 1D
`Comm. module
`100 informs
`
`227
`
`
`
`
`
`
`
`
`
`Uploaded data
`compared with
`pre—programmed
`ranges of data
`
`
`IMD
`that
`patient
`10 and/or comm.
`module 100
`
`
`
`parameters OK
`
`
`
`
`
`
`
`Uploaded info./
`data within
`"safe" ranges?
`
`
`
`
`307
`
`Comm. module 100 contacts
`remote system 130 via
`mobile phone 110 and
`relays data/info.
`thereto
`
`215/217/219/229
`
`
`
`Patient
`is called
`back using ca|lerID
`
`
`and collect call
`charging (pre—
`
`
`authorized) with
`diagnostic
`assessment at
`$X/min; available
`therapeutic options
`are communicated
`
`to the patient
`
`
`
`
`
`
`Patient's health
`care provider
`communication
`
`
`
`
`
`
`is charged
`bill
`with $X/min
`diagnostic charge
`
`
`
`FIG. 9C-l
`
`

`
`U.S. Patent
`
`Oct. 12, 2004
`
`Sheet 14 of 23
`
`US 6,804,558 B2
`
`223
`
` Palient receives
`other therapeutic
`or medical advice
`
`
`
`
`
`
`Patient accepts
`charges for
`"periodic
`surveiilonce calls"?
`
`
`Put patient on
`.
`I
`periodic
`surveillance ?
`
`
`
`
`20 E
`
`Patient accepts
`mail order
`
`pharmacy charges
`to be biiied
`
`Patient needs drug
`prescription?
`
`217
`
`
`Ambulance is sent
`(service charge is
`bilied)
`
`Patients should go
`to ECU?
`
`231
`
`
`
`changed?
`
`Patient/comm module
`100 accepts
`217 M parameter changes
`
`Parameters of IMD
`
`O or comm module
`100 shouid be
`
`Yes
`
`FIG. 9C—2
`
`

`
`U.S. Patent
`
`Oct. 12,2004
`
`Sheet 15 of 23
`
`US 6,804,558 B2
`
`3Dt
`
`
`
`
`MD 10 and/or comm. module 100 detects/senses
`threshold event or predetermined doteftime arrives
`
`
`
`325
`
`
`
`Comm. module 100
`
`and phone 110
`
`
`provide confirmation
`
`
`that remediat
`response has been
`
`carried out
`
`
`
`
`Remedial response
`carried out by
`IMO 10 and/or
`communication
`
`
`
`module 100/110
`
`
`
`
`
`Remedial response
`relayed to comm.
`module 100 and/or
`IMD10 via phone 110
`
`
`
` Determined
`appropriate
`
`remedial response
`
`executed by
`remote heaith
`
`care provider 136
`
`and/or remote
`
`computer system
`or expert system
`
`
`
`
`
`
`
`
`
`303
`
`305
`
`
`
`MD 10 and/or comm. module 100 initiates
`upiooding of data from IMO 10
`
`IME} 10 and comm. module 100
`communicate, data are uploaded
`
`
`
`
`
`
`307
`
`Comm module 100 and mobile
`
`telephone 110 communicate, data are
`
`relayed to remote system 130
`via communication system 120
`
`
`
`
`
`1:
`
`
`
`309
`
`
`
`Remote health care provider 136
`and/or remote computer or expert
`
`system review and/or analyze data
`
`
`
`
`
`
`
`
`
`
`
`3“
`
`Diagnosis of patient 5 carried out b
`remote health care provider 136 and or
`remote computer or expert system 150
`
`
`
`Patient 5
`comm. module 100 and/or
`IMO ‘I0 require further
`
`attention ‘?
`
`
`
`
`
`
`Patient 5 is
`
`sent message that
`no further medical
`attention is required
`
`517
`
`Remote health care provider 1:55
`and/or remote computer or expert system
`1150 determines appropriate remedial response
`based on diagnosis
`
`L
`
`FIG.
`
`IOA
`
`

`
`U.S. Patent
`
`Oct. 12,2004
`
`Sheet 10 of 23
`
`US 6,804,558 B2
`
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`
`U.S. Patent
`
`Oct. 12, 2004
`
`Sheet 17 of 23
`
`US 6,804,558 B2
`
`425
`
`401
`
`
`
` 403
`
`Health care provider 136 and/or remote system
`130 decide to interrogate IMD 10 and/or module 100 Comm. module 100
`and phone 110
`provide confirmation
`that remedial
`response has been
`carried out
`
`
`
`
`
`
`ND 10 and comm. module I00
`communicate. data are uploaded
`
`Comm module 100 and mobile
`
`telephone 110 communicate. data are
`relayed to remote system 150
`via communication system 120
`
`T
`
`Remedial response
`carried out by
`IMD 10 and/or
`communication
`module 100/110
`
`Remote health care provider 135
`and/or remote computer or expert
`system review and/or onalyze data
`
`response
`Remedial
`relayed to comm.
`module 100 and/or
`IMD10 via phone 110
`
`405
`
`407’
`
`
`
`
`409
`
`
`Health care provider 136 and/or remote
`system 130 communicate with module 100
`via mobile telephone 110
`
`Determined
`
`appropriate
`remedial response
`executed by
`remote health
`
`care provider 136
`and/or remote
`computer system
`or expert system
`
`
`
`in
`Diagnosis of patient 5 carried out
`remote health care provider 136 and or
`remote computer or expert system 130
`
`
`
`411
`
`
`
`
`
`Patient 5
`comm. module 100 and/or
`IMD 10 require further
`attention
`
`
`
`
`Patient 5 is
`
`
`
`sent message that
`no further medical
`attention is required
`
`
`
`
`
`
`
`Remote health care provider 136
`and/or remote computer or expert system
`130 determines appropriate remedial response
`based on diagnosis
`
`
`
`FIG.
`
`I IA
`
`

`
`U.S. Patent
`
`1
`
`US 6,804,558 B2
`
`
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`

`
`U.S. Patent
`
`Oct. 12,2004
`
`Sheet 19 of 23
`
`US 6,804,558 B2
`
`IMD 10
`
`\\;::—f/__/
`/'—‘\
`
`C°"“9”r°ti°“
`d°t°b°5°
`
`Dispiuy and/or
`user interface
`103
`
`Management
`module
`Q
`
`FIG.
`
`|2A
`
`

`
`U.S. Patent
`
`Oct. 12,2004
`
`Sheet 20 of 23
`
`US 6,804,558 B2
`
`140
`
`142
`
`
`Initiating a connection between
`communication module 100 and/or MD 10 and
`remote system 130 via phone 120
`
`‘I44
`
`145
`
`
`Transmitting current configuration
`of communication module 100 and/or IMD 10
`to remote system 130 via phone 110
`6 - - - - * - - - - - - - - - - - — -
`
`approved by the manufacturer of
`IMD 10 and/or communication module 100
`
` Identifying software applications
`
`Generate automatic
`invoice
`
`
`
`
`
`
`
`
`
`
`150
`
`Accessing the approved software
`applications for IMD 10 and/or
`communication module 100
`
`
`
`Transmitting and installing the
`152
`approved software applications to IMD 10
`
`and/or comm. module 100 via mobile phone 110
`
`Generate automatic
`
`invoice
`
`
`
`
`154
`
`
`
`Updating the configuration
`information within MD 10 and/or
`communications module 100 via phone 110
`
`
`156
`
`Updating the {MD 10 and/or comm. module 100
`configuration database located
`
`within remote system 130
`
`FIG.
`
`|2B
`
`
`
`
`
`
`
`148
`
`Identifying software applications
`approved by a governing body in the
`country in which the ND 10 and/or
`communication module 100 is located
`
`

`
`U.S. Patent
`
`Oct. 12, 2004
`
`Sheet 21 of 23
`
`US 6,804,558 B2
`
`Initiate a
`connection
`between
`
`and MD 10
`
`remote system 1.30
`
`Retrieve
`
`current
`information
`
`
`from MD 10
`
`Identify
`updated
`software
`
`
` Software
`
`approved by
`anufacturer’?
`
`
`
`
`Software
`approved by
`gov’?
`
`
`
`Software
`
`needs
`modification?
`
`
`150
`
`152
`
`164
`
`165
`
`168
`
`HO
`
`
`
`
`Record and
`end session
`
`159
`
`176
`
`
`
`
`Problems with
`
`programmer?
`
`
`
`programmer
`denying instaiiation
`at this
`time?
`
`
`
`Install s.w.
`
`182
`
`‘S4
`
`Y I
`
`nstali
`iater
`
`180
`
`FIG.
`
`|2C
`
`Y M
`
`odify
`software
`
`End session
`
`172
`
`174
`
`

`
`U.S. Patent
`
`Oct. 12, 2004
`
`Sheet 22 of 23
`
`US 6,804,558 B2
`
`501
`525
`
`
`Patient 5 or IMO 10
`communication module
`
`00 determines emergency medicat service required Comm. module 100
`and phone 110
`provide confirmation
`that remedial
`response has been
`carried out
`
`
`
`
`
`Patient 5 and/or IMD 10/‘ comm. module 100
`initiates upload of data
`
`
`
`
`
`
`1
`
`Patient notified that
`no EMS is required
`
`Comm‘ Module 100
`determines no
`emergency medical
`service is required
`
`Comm. Module 100
`determines emergency
`medical service is
`required
`
`Comm. Module 100
`mobile telephone
`communicate
`directly with
`emergency medical
`service to coil
`
`523
`
`Remedial response
`carried out by
`]MD 10 and/or
`communication
`moduie 100/ 110
`
`Remedial response
`relayed to comm.
`module 100 and/or
`IMD10 via phone 110
`
`Determined
`appropriate
`remedial response
`executed by
`remote health
`
`care provider 136
`and/or remote
`computer system
`or expert system
`
`communicate, data are uploaded
`ambulance Diagnosis of patient 5 carried out b
`
`IMD 10 and comm. module 100
`
`
`Comm module 100 and mobile
`telephone 110 communicate. data are
`relayed to remote system 1150
`via communication system 120
`
`
`
`
`
`
`Remote health care provider 1556
`and/or remote computer or expert
`system review and/or analyze data
`
`
`
`
`
`
`
`I35 and or
`remote health care provider
`remote computer or expert system 130
`
`
`
`
`
`
`Patient 5
`comm. module 100 and/or
`MD it] require further
`attention
`
`9
`
`Patient 5 is
`sent message that
`no further medical
`attention is required
`
`
`
`
`
`51?
`
`l36
`Remote health care provider
`and/or remote computer or expert system
`150 determines appropriate remedial response
`based on diagnosis
`
`T
`
`FIG.
`
`ISA
`
`

`
`U.S. Patent
`
`Oct. 12, 2004
`
`Sheet 23 of 23
`
`US 6,804,558 B2
`
`
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`
`US 6,804,558 B2
`
`1
`SYSTEM AND METHOD OF
`COMMUNICATING BETWEEN AN
`IMPLANTABLE MEDICAL DEVICE AND A
`REMOTE COMPUTER SYSTEM OR
`I-IF..AI.TH CARE PROVIDER
`
`RELATED PATENT APPLICATIONS
`
`This patent application claims priority and other benefits
`from U.S. Provisional Patent Application Ser. No. 601176,
`499 entitled “Method and System for Patient Controlled
`Data Exchange between Physician and Implanted Device” to
`Haller et al. filed Jan. 18, 2000, and incorporates the entirety
`of same by reference herein. This patent application is also
`a continuation-in-part of U.S. patent application Ser. No.
`U9,t348,5(J6 entitled “System for Remote Communication
`with a Medical Device" to Ferek-Petric filed Jul. 7, 1999,
`and incorporates the entirety of same by reference herein.
`Also incorporated by reference herein, each in its respec-
`tive entirety, are the following pending US. patent applica-
`tions: (1) U.S. patent appln. Scr. No. O9f430,208 filed Oct.
`29, 2000 for “Automatic Invoice upon Pacemaker Implant”
`to Linberg; (2) U.S. patent appln. Ser. No. 09t"466,284- iiled
`I)ec. 17, 1999 for “A Virtual Electrophysiologic Value-
`Added Service for Cardiac Rhythm" to Linberg et al.; (3)
`US. patent appln. Ser. No. (l9.«'43'z',615 filed Nov. 10, 1999
`for "Method for Remote Delivery of Software-Based Train-
`ing with Automated Support for Certification and Enabling
`Software Applications on Programmers” to Linberg; (4)
`U.S. patent appln. Ser. No. 09M-26,741 filed Oct. 26, 1999
`for "Remote Troubleshooting and Preventive Maintenance
`of Programmers" to Linberg; (5) U.S. patent appln. Ser. No.
`O9;’429,960 filed Oct. 29, i999 for "Method to Automate
`Remote Medical Instrument Updates’”' to Linberg; and (6)
`U.S. patent appln. Ser. No. 09M-29,956 filed Oct. 29, 1999
`for "Electronic Self—Identification of Medical Instruments
`and Smart Peripherals” to Linberg.
`
`FIE[.D OF THE INVENTION
`
`The present invention relates generally to medical device
`systems, and more particularly relates to a system and
`method for communication between an IMI.) and a remote
`computer andfor health care provider employing a mobile
`telephone and a communication module linked thereto.
`
`BACKGROUND OF THE INVENTION
`
`An ideal technology-based health care system would be
`capable of fully integrating the technical and social aspects
`of patient care and therapy and permit a patient or a medical
`device implanted within the patient
`to communicate a
`remote computer system or health care provider irrespective
`ofthe location ofthe patient, the remote computer system or
`the health care provider. While clinicians will continue to
`treat patients in accordance with accepted modem medical
`practice, developments in communications technology are
`making it ever more possible to provide medical services in
`a time and place independent manner.
`Prior art methods of providing clinical medical services
`are generally limited to in-hospital or in-clinic procedures.
`For example, if a physician must review the performance
`parameters of an implantable medical device (hereinafter
`“lMD") in a patient, it is likely the patient will have to visit
`a clinic or hospital where the review can accomplished. If
`the medical conditions of a patient having an IMD warrant
`continuous monitoring or adjustment of the device,
`the
`patient may have to remain at the hospital. Such continued
`
`2
`treatment poses economic and social problems.
`Additionally, patients’ physical movements are restricted
`and patients are inconvenienced by the need to visit or stay
`in a hospital or a clinic. As the proportion of the population
`with implanted medical devices increases, ever more
`hospitals, clinics and service personnel will be required to
`provide in—hospital or in-clinic services to such patients, thus
`escalating healthcare costs.
`In accordance with prior art practice, most patient having
`IMDs are required to visit a clinical center for occasional
`retrieval of data therefrom. Typically,
`the IMD’s perfor-
`mance is assessed and patient data are acquired for clinical
`and research purposes. Such data is usually acquired by
`having the patient visit a hospital or clinic where data stored
`in the memory of the IMD is uploaded to a programmer.
`Depending on the frequency of data acquisition and storage,
`this procedure can result in difliculty and inconvenience for
`patients living in rural areas or having limited physical
`mobility. Similarly,
`if the software in an IMD must be
`updated,
`the patient is required to come into a clinic or
`hospital to have the upgrade installed.
`The prior art discloses various types of remote sensing
`and communication systems that interact with IMDS. One
`such system is disclosed in Funkc, U.S. Pat. No. 4,987,897.
`This patent discloses a system that
`is at
`least partially
`implanted into a living body with a minimum of two
`implanted devices interconnected by a communication
`transmission channel. The invention further discloses wire-
`less communications between an external medical device!
`programmer and an implanted device.
`Another example of a prior art sensing and communica-
`tion system is disclosed by Strandberg in U.S. Pat. No.
`4,886,064. In this patent, body activity sensors, such as
`temperature, motion, respiration andtor blood oxygen
`sensors, are positioned in a patient’s body outside a pacer
`capsule. The sensors wirelessly transmit body activity
`signals, which are processed by circuitry in the heart pacer.
`The heart pacing functions are influenced by the processed
`signals. The signal transmission is a two-way network and
`allows the sensors to receive control signals for altering the
`sensor characteristics.
`
`In U.S. Pat. No. 4,494,950, Iiischel] discloses a system
`consisting ofa plurality of separate modules that collectively
`perform a useful biomedical purpose. The modules commu-
`nicate electromagnetically with one another without the use
`of interconnecting wires. Physiologic sensor measurements
`sent from a first-modttle cause a second module to perform
`some function in a closed loop manner.
`One example of remote monitoring of implanted cardio-
`verter defibrillators is U.S. Pat. No. 5,321,618 to Gessman,
`where a remote apparatus is adapted to receive commands
`from and transmit data to a central monitoring facility over
`telephone communication channels. The remote apparatus
`includes equipment
`for acquiring a patient’s ECG and
`transmitting same to the central facility using telephone
`communications channels. The remote apparatus also
`includes a segment, responsive to a command received from
`the central monitoring facility, for enabling the emission of
`audio tone signals from the cardioverter defibrillator. The
`audio tones are detected and sent to the central monitoring
`facility via the telephone communication channel. The
`remote apparatus also includes patient alert devices, which
`are activated by commands received from the central moni-
`toring facility over the telephone communication channel.
`An additional example of prior art practice includes a
`packet-based telemedicine system for communicating infor-
`
`'2:
`
`I0
`
`15
`
`30
`
`Is.)ran
`
`3U
`
`40
`
`45
`
`SD
`
`55
`
`60
`
`E55
`
`

`
`US 6,804,558 B2
`
`3
`mation between central monitoring stations and a remote
`patient monitoring station disclosed by Pfeiffer
`in WO
`99714882 published Mar. 25, 1999. 'This disclosure relates to
`a packet-based telemedicine system for communicating
`video, voice and medical data between a central monitoring
`station and a patient that is remotely located with respect to
`the central monitoring station. The patient monitoring sta-
`tion obtaitis digital video, voice and medical measurement
`data from a patient and encapsulates the data in packets and
`sends the packets over a network to the central monitoring
`station. Since the information is encapsulated in packets, the
`information can be sent over multiple types or combination
`of network architectures,
`including a community access
`television (CATV) network, the public switched telephone
`network (1-’S'I'N),
`the integrated services digital network
`(ISBN), the Internet, a local area network (LAN), a wide
`area network {WAN}, over a wireless communications
`network, or over asynchronous transfer mode (ATM) net-
`work. A separate transmission code is not required for each
`different type of transmission media.
`is
`IMD:-t
`Another example of a telemetry system for
`disclosed by Duffin et al.
`in U.S. Pat. No. 5,752,976. The
`Duflin disclosure relates to a system-and method for com-
`municating with a medical device implanted in an ambula-
`tory patient and for locating the patient in order to selec-
`tively monitor device titnction from a remote medical
`support network. The communications link between the
`medical support network and the patient communications
`control device may comprise a world wide satellite network,
`a cellular telephone network or other personal communica-
`tions system.
`Thompson et at. disclose a patient tracking system in US.
`Pat. Nos. 6,083,248 and 5,752,976 entitled "World-wide
`Patient Location and Data Telemetry System For IMDs”.
`Thompson et al. also describe features for patient tracking in
`a mobile environment worldwide via the GPS system.
`Ferek—Pctric discloses a system for communication with a
`medical device in co-pending U.S. patent application Ser.
`No. 09J348,506 entitled "System for Remote Communica-
`tion with a Medical Device” filed Jul. 7, 1999. Ferek-Petric’s
`disclosure relates to a system that permits remote commu-
`nications with a medical device, such as a programmer.
`Experts provide guidance and support
`to remote service
`personnel or operators located at
`the programmer. The
`system may include a medical device adapted to be
`implanted into a patient; a server PC communicating with
`the medical device; the server PC having means for receiv-
`ing data transmitted across a dispersed data communication
`pathway, such as the Internet; and a client PC having means
`for receiving data transmitted across a dispersed communi-
`cations pathway from the SPC. In certain configurations the
`server PC may have means for transmitting data across a
`dispersed data communication pathway (Internet) along a
`first channel and a second channel; and the client PC may
`have means for receiving data across a dispersed commu-
`nication pathway from the server PC along a first channel
`and a second channel.
`
`Ferek—Petric further discloses the implementation of com-
`munication systems associated with [MDs that are compat-
`ible with the Internet. The communications scheme is struc-
`
`remote experts to existing or
`tured primarily to alert
`impending problems with the programming device so that
`prudent action, such as early maintenance or other remedial
`steps, may be exercised in a timely manner. Further, because
`of the early warning or advance knowledge of the problem,
`the remote expert would be well informed to provide remote
`advice or guidance to service personnel or operators at the
`programmer.
`
`'2:
`
`I0
`
`15
`
`20
`
`Is.)ran
`
`3U
`
`40
`
`45
`
`S0
`
`55
`
`60
`
`4
`In US. Pat. No. 5,800,473, Faisandier et al. provide a
`system and method for the automatic update of the software
`of an external programmer implant that is used to program
`and configure an active IMD implant and acquire data
`obtained by the implant. The programmer comprises soft-
`ware composed of an assembly of software objects. The
`implant comprises a memory containing parametric data for
`the functioning of the implant and an assembly of software
`objects necessary for the functioning of the programmer in
`connection with the parametric data.
`In U.S. Pat. No. 5,772,586 to Heinonen et al., there is
`disclosed a method for monitoring the health of a patient by
`utilizing measurements. The measurements are supplied via
`a communication device utilizing a wireless data transmis-
`sion link to a data processing system available to the person
`monitoring the patient’s health. The patient’s health is
`monitored by means of the data stored in the data processing
`system.
`
`In El’ 0 987 047 A2 to Lang et al. entitled “Patient
`Monitoring System” having a priority date of Sep. 18, i998,
`there is a description of sensing and acquiring physiological
`data with a pacemaker or defibrillator, and transmitting those
`data by mobile phone to an external system accessible by a
`cardiologist. The cardiologist may then evaluate the data and
`initiate emergency action such ordering an ambulance. The
`mobile phone may also be employed to determine the
`patient’s geographical location, as well as to transmit a
`signal warning of a low State of charge in the pacemaker or
`defibrillator battery.
`It will now be seen that there exist many unfulfilled needs
`to more easily, quickly and cost-elfectively monitor and
`control the performance of an IMD in a patient on a regular
`or continuous basis, where the patient is not required to visit
`a health care facility or a health care provider in person when
`the monitoring is undertaken. It will also now be seen that
`there exist many unfulfilled needs to more easily, quickly
`and cost efiectively monitor and control
`the health of a
`patient having an IMD on a regular or continuous basis,
`where the