throbber
United States Patent
`US 6,443,890 B1
`(10) Patent No.:
`(12)
`Schulzeet al.
`(45) Date of Patent:
`Sep. 3, 2002
`
`
`US006443890B1
`
`(54) WIRELESS INTERNET BIO-TELEMETRY
`MONITORING SYSTEM
`
`(75)
`
`Inventors: Arthur E. Schulze, Wharton, TX (US);
`TommyG. Cooper, Friendswood, TX
`(US); Emil S. Macha, Sugar Land, TX
`US(US)
`i-Medik, Inc., Santa Fe, NM (US)
`
`(73) Assignee:
`
`(*) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`US.C. 154(b) by 0 days.
`
`(21) Appl. No.: 09/516,645
`4.
`Filed:
`(22)
`Mar.1, 2000
`(SL)
`Tint. C1? oe eceeeeeececsecesensneeneeneneensenes A61B 5/00
`(52) US. CMe
`cocccoceccccecceccccee. 600/300; 128/903; 128/904;
`, 128/920: 600/301
`(58) Field of Search
`41281904 903
`128900, 897-898, 920-925: 600300-301,
`“
`.
`aa
`,
`;
`:
`481, 500, 529, 549, 545; 702/2-3
`References Cited
`U.S. PATENT DOCUMENTS
`
`(56)
`
`5/1996 Myllymaki
`5,515,858 A *
`.........0.... 600/503
`8/1996 Davis etal.
`5.544.661 A *
`~~ 600/300
`
`5,673,692 A * 10/1997 Schulze et al. oe. 600/301
`5,678,562 A * 10/1997 Sellers
`6,168,563 Bl *
`2/2001 Brown oo... cece 600/301
`
`5/2001 Kail, IV owe 128/904
`
`5/2001 Blants et al. wc. 600/529
`7/2001 Albert et al. wc. 600/528
`9/2001 Zureketal.
`9/2001 Duffin et al. 0. 607/32
`
`6,225,001 B1 *
`6,231,519 B1 *
`6,264,614 BL *
`6,292,573 Bl *
`6,292,698 B1 *
`* cited by examiner
`Primary Examiner—Kevin Shaver
`Assistant Examiner—Michael C Astorino
`(74) Attorney, Agent, or Firm—Roberts, Abokhair &
`Mardula, LLC
`ABSTRACT
`67
`Asystem and method for monitoring patient variables in a
`wireless mode via a patient worn monitoring devices. The
`patient worn monitoring device connects to a variety of
`bio-sensors with at least one microphone for voice commu-
`nications. The pertinent worn device connects to a wireless
`network and thence to the internetfor transmitting voice and
`data to a health care provider. The health care provider
`communicates with the patient worn device via the internet
`and the wireless network to send instructions to the patient
`worn monitoring unit and to communicate via voice with the
`patent. The health care providercan also flexibly reconfigure
`the patent worn monitoring device to change collection
`parameters for the bio-sensors worn by the patient. When an
`alarm limit is exceeded an detected by the bio-sensors,it is
`transmitted to the health care provider over the wireless
`:
`.
`network and thence over the internet thereby allowing full
`‘mobility to the patient wearing the device.
`
`14 Claims, 3 Drawing Sheets
`
`72
`70
`
`LCD DISPLAY
`|

`
`TIME OF DAY
`SIGNAL STRENGTH
`
`
`BATTERY
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`RED LED
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`ALARM
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`80-4
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`EVENT
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`
`
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`a FLASHING GREEN LED
`POWFR ————_
`
`0001
`
`Apple Inc.
`APL1062
`U.S. Patent No. 8,652,040
`
`Apple Inc.
`APL1062
`U.S. Patent No. 8,652,040
`
`0001
`
`

`

`U.S. Patent
`
`Sep. 3, 2002
`
`Sheet 1 of 3
`
`US 6,443,890 B1
`
`IWOIdAN AYNSIANOD
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`

`

`U.S. Patent
`
`Sep. 3, 2002
`
`Sheet 2 of 3
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`US 6,443,890 B1
`
`Fig. 2
`
`62
`
`56
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`60
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`SENSO PROB
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`DATA
`ACQUIT
`MODULE
`
`32
`
`SpO2
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`CALL 911
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`CALL MED
`
`34
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`36
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`38
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`40
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`42
`CARE AgCONFIGURE
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`VOICE ALERT
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`56
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`CDMA
`MODULE
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`SYNTHESIZE
`
`VOICE
`
`44
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`BIO-SIGNALS
`
`ALARM
`
`TIME OF DAY
`
`VOICE
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`INTERROGATE
`
`0003
`
`0003
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`

`

`U.S. Patent
`
`Sep. 3, 2002
`
`Sheet 3 of 3
`
`US 6,443,890 B1
`
`Fig.3
`
`70
`
`TIME OF DAY
`
`SIGNAL STRENGTH
`
`
`
` LCD DISPLAY
`
`
` BATTERY
`:bn
`—ioe86
`
`9:41am
`
`()
`
`76
`
`CALL
`
`78
`
`80
`
`911
`
`CALL
`CARE
`
`EVENT
`
`POWER
`
`SPEED DIALING PRE-SETS
`
`SENSOR
`
`ALARM
`
`OL,
`
` FLASHING GREEN LED
`
`0004
`
`0004
`
`

`

`US 6,443,890 B1
`
`1
`WIRELESS INTERNET BIO-TELEMETRY
`MONITORING SYSTEM
`
`FIELD OF THE INVENTION
`
`This invention relates generally to medical monitoring
`devices. More particularly the present invention is a system
`and method for monitoring physiologic variables of an
`individual in a wireless mode over the Internet.
`
`BACKGROUND OF THE INVENTION
`
`Monitoring devices of various types to monitor patient
`physiologic conditions have long been in the medical com-
`munity. A plethora of testing and monitoring equipment have
`moved out of the hospital into the doctors’ offices and, in
`some cases have even progressed into home monitoring
`systems.
`While these devices have clearly been extremely useful,
`many of these devices require that a patient be located at
`home,or in close proximity to a telephone system such that
`results of the monitoring can be transmitted over the public
`switch telephone network (PSTN) to some form ofanalysis
`center. Such devices do not necessarily lend themselves to
`the mobile life style in which many individuals find them-
`selves.
`
`10
`
`15
`
`,
`
`For example, it is difficult for a busy person to stop in the
`middle of the day, proceed to a monitoring station, whether
`it be a home or in some office,
`take the appropriate
`measurements, is and then proceed with the business of the
`day. This is simply not possible and addsa level of stress to ,
`the already stressful situation of having to monitor physi-
`ologic signals.
`What would be truly useful is a system for monitoring
`physiologic characteristics of an individual on a mobile
`basis. Such a system would require little if any interaction
`with a monitoring device. Signals that are collected would
`then be sent in an automated fashionto an analysis center or
`a physician’s office. Alternatively a physician could inter-
`rogate the system worn by a patient while the patient is
`mobile to obtain the physiologic signals of interest.
`SUMMARYOF THE INVENTION
`
`40
`
`It is therefore an objective of the present invention to
`remotely monitor physiologic variables from any patient.
`It is a further objective of the present invention to monitor
`physiologic variables of a patient whether the patient is
`ambulatory or stationary when the physician is remote from
`the patient.
`invention to
`It is yet another objective of the present
`monitor physiologic variables using the Internet.
`It is a further objective of the present invention to monitor
`physiologic variables in a wireless manner within a gener-
`alized geographic area.
`It is further objective of the present invention to monitor
`physiologic variables without the patient having to proceed
`to any centralized location in a geographic area.
`It is further objective of the present invention to monitor
`a patient anywhere in the coverage map of a cellular or
`satellite based telephone network.
`It is further objective of the present invention to have data
`relating to physiologic variables automatically sent over a
`wireless network to a physician or other medical caregiver.
`It is further objective of the present invention to allow a
`physician to interrogate the physiologic monitoring device
`in a wireless fashion wheneverthe physician needs to take
`such physiologic measurements.
`
`45
`
`60
`
`65
`
`2
`It is further objective of the present invention to provide
`to a voice communications in a wireless mode to a medical
`caregiver.
`It is further objective of the present invention to have a
`“panic” function which allows both a user to send a “panic”
`message to a physician or allow a physician, after monitor-
`ing physiologic signals, to send a voice “advice” message to
`the patient.
`It is further objective of the present invention to accom-
`plish all the above objectives using a device that is worn by
`the patient in a relatively unobtrusive fashion.
`These and other objectives of the present invention will
`becomeapparent to those skilled in the art from a review of
`the specification that follows.
`The present invention is a wireless Internet bio-telemetry
`monitoring system (WIBMS). The system makes use of a
`variety of bio-sensors which are generally used to detect
`signals or variables from the human body. One such sensor
`system is described in U.S. Pat. No. 5,673,692 whose
`characteristics are incorporated herein by reference in their
`enlirely, wherein a single site, multi-variable patient moni-
`toring apparatus for monitoring multiple physiological vari-
`ables of a patient at a single site on the patient is disclosed
`for ambulatory monitoring, home monitoring, procedure
`monitoring and similar situations. ‘he apparatus has an
`infrared (IR) temperature sensor, a pulse oximeter sensor
`and a communication circuit for outputting information
`produced from the pulse oximeter and information produced
`from the infrared temperature measuring device. These
`elements are integrally placed within a mold or plug made
`to fit the ear of the patient. However, this particular sensor
`is not meantas a limitation. Literally any type of bio-sensor
`generally knownto those skilled in the art will find use in the
`present
`invention. Further the sensor of U.S. Pat. No.
`5,673,692 can further be modified to include a microphone
`so that voice of the patient can be transmitted using the
`sysiem of the present invention.
`The bio-sensors are connected to a combination data
`acquisition module and wireless transceiver which is worn
`by the patient. This combination sensor package and com-
`munication unit
`is known as the multi-variable patient
`monitor, or MVPM. The MVPMis battery powered. The
`batteries that power the MVPM can besingle use batteries
`or rechargeable batteries. Further, when the individual is in
`a mobile state, the batteries of the MVPM can be recharged
`by plugging into a car or into normal wall current. This
`allows the individual to constantly keep batteries charged in
`the MVPM whetherthe individual is mobile or in anoffice.
`
`As noted above, the MVPM is a combination patient-
`worn device which allows maximum mobility to the par-
`ticular patient.
`to
`The MVPM has the ability, on a periodic basis,
`interrogate bio-sensors worn by the patient and to store
`physiologic signals from the bio sensors. On a periodic
`basic, the MVPM calls into a wireless network and transmits
`the bio-sensor information to the wireless network. The
`bio-sensor information then proceeds from the wireless
`network to the Internet and then to an analysis center or a
`data warehouse which receives and stores the information
`for subsequent analysis.
`The MVPMalso comprises an emergency “panic” button
`whereby a patient can direct the transceiver portion of the
`MVPMto automatically call 911 in the event of a medical
`emergency.
`the MVPM is connected to various
`As noted above,
`bio-sensors. Therefore the MVPM has sensor condition
`
`0005
`
`0005
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`

`

`US 6,443,890 B1
`
`3
`detection circuitry, connected to a lamp, which allows a user
`to determinethat all sensors are operating correctly. When a
`senor receives a particular signal which is out of the normal
`physiologic range for the particular patient, an alarm sound
`and light are actuated such that the individual can under-
`stand that a significant medical event is occurring. Simul-
`taneously with such an alarm,a time-tagged signal is sent to
`the medical care provider notifying the providerof the event.
`Thus, when the MVPM is functioning in a data acquisi-
`tion mode, it receives information from the sensors, per-
`forms some limited analysis on that information and has the
`ability to notify the patient of any non-standard conditions.
`When the MVPM periodically sends stored signals from
`the bio sensor over the network a unique identifier is
`associated with any such data that is sent such that the data
`can be directly associated with a particular patient.
`Once data are received at the server, the data are stored
`with appropriate privacy and securily issues dealt with in a
`manner knownto those skilled in theart.
`
`10
`
`15
`
`The MVPM also comprises circuitry for self testing its
`various sub systems and sensors and for communicating any
`trouble shooting information directly to the patient in the
`event that the sensor becomes dislodged or non-functional.
`Further, such trouble shooting data can also be sent in a
`wireless mode to the central server such that trouble shoot-
`ing can take place remotely, or in the alternative, a new
`MVPMunit can be sent to the patient.
`The MVPMalso canbe preset before giving it to a patient.
`In addition, and depending uponthe biological signals being ;
`monitored, alarms can be set remotely by the health care
`provider over the internet and subsequently via the wireless
`network and can be based upon the caregiver’s knowledge
`of the condition of the patient. Such remote setting also
`occurs via the two way communication of the transceiver ,
`portion of the MVPM.
`Communication rates of the WIBMSare optimizedto fit
`common cellular calling and rate plans and to minimize the
`cost and air time usage.
`Using the WIBMSthe following types of monitoring can
`take place:
`digitally sampled electrocardiogram
`patient body temperature
`pulse oximetry
`pulse rate
`other physiologic variables, such as blood glucose,
`respiration, etc.
`various pre set alarm conditions or physiologic variables
`event occurrences per patient action/input.
`As also noted above the MVPM hasbi-directional com-
`
`40
`
`45
`
`4
`DETAILED DESCRIPTION OF THE
`INVENTION
`
`As noted above the present inventionis a wireless Internet
`bio-telemetry system comprising a patient monitoring
`device which is conveniently worn by a patient and which
`comprises bio-sensors together with a combination network
`that allows biologic data to be reviewed and acted upon by
`a health care provider who is located remotely from the
`patient. Data from the monitoring system are then sent in a
`wireless mode over a cellular network to both the public
`switched telephone network (PSTN)or over the Internet to
`a data analysis center and/or to a medical care provider.
`Referring first to FIG. 1 the wireless Internet bio telemetry
`system (WIBMS)isillustrated. Patient 10 wears a multi-
`variable patient monitor (MVPM) 12. This MVPM monitors
`a variety of bio-signals as further noted below. The MVPM
`12 has the capability of communicating bi-directionally via
`voice 14 in much the same manner as a normal cellular
`
`telephone. However, in addition, the MVPM sendsdata 16
`on a periodic basis, or in some cases on a continuousreal
`lime basis, over a cellular network as well as receives
`requests for data 18 which may be made by a medical care
`provider over the cellular telephone network.
`Cellular telephone network 20 is the normal digital cel-
`lular telephone network currently in use. This type of
`network is not however meantas a limitation. For example
`PCS networks and other types of wireless local loop net-
`worksare also suitable for transmission of the voice and data
`envisioned by the present invention. It will be apparent to
`those skilled in the art that such other networks cansatisfy
`the requirements for transmission of voice 14, data 16, and
`request for data 18 to and from patient 10.
`Once physiologic data is transmitted over network 20,it
`is then transmitted via an Internetworking Function (IWF)®
`24 (for example) to, preferably the Internet 26 for subse-
`quent communication over the Internet
`to the Host for
`retrieval and review by the medical care provider 28. In
`addition, data can be archived again via the Internet 26 to a
`data archiving and distribution facility 30 (“Host”). Data
`that are archived are stored in a private and secure fashion
`using techniques known in the art that allow secure trans-
`mission and access limitations.
`
`In the eventthat voicetraffic is being transmitted from the
`patient,
`a cellular network 20 connects to the public
`switched telephone network 22 which connects to the medi-
`cal care provider (or 911 operator). Again, in this fashion,
`the medical care provider can receive voice information
`from the patient 10 and provide voice feedbackto the patient
`as well. Similarly, the medical care provider 28 can both
`receive traffic from the WIBMSas well as transmit requests
`for data over Internet 26 through TWF 24 over the cellular
`network 20 through the Internet via the data repository
`(Host) to the MVPM 12 as well as configure 19 the WVPM.
`All data that is received from the MVPMandthe network
`
`munication capability and has the capability to transmit a
`“panic” signal over wireless network, to initate 911 calls, to
`allow a patient-initiated voice calling over a cellular tele-
`phone link, and to allow medical provider voice calling to
`the patient over a cellular telephone link.
`Other characteristics of the present invention will become
`apparent to those skilled in the art by review of the detailed
`description of the invention that follows.
`BRIEF DESCRIPTION OF THE FIGURES
`
`FIG. 1 illustrates the wireless Internet bio telemetry
`system.
`FIG. 2 illustrates the multi variable patient monitoring
`portion of the WIBMS
`FIG. 3 illustrates a front panel drawing of the multi
`variable patient monitor portion of the WIBMS
`
`is archived 30 so that the data from the specific patient can
`be monitored over time and so that data can be analyzed for
`trends that can be used for alarm setting and data collection
`protocols. All such data is transmitted in an encrypted and
`possibly non-attributable form with limited access using
`methods known in the art so that patient privacy and
`confidentiality is maintained.
`Referring to FIG. 2, the multi variable patient monitor
`(MVPM) is further illustrated. The MVPM (initially noted
`as 12 in FIG. 1) comprises, without limitation a number of
`bio-sensors. For example, blood oxygen saturation level 32,
`pulse rate 34, and body temperature 36 can all be measured
`
`60
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`65
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`

`US 6,443,890 B1
`
`5
`by bio sensors associated with the appropriate measurement.
`Signals from the sensors are picked up andstored by the data
`acquisition module 42. This information from the bio sen-
`sors 44 is then sent to the CDMA(although other protocols
`mayalso be used) module 56 of the MVPM for subsequent
`transmission.
`
`6
`by a dedicated function “button” on the MVPM. Again,data
`acquisition module 42 processes voice information 50 and
`passes that information to the CDMA module 56.
`As noted above the medical service provider or other
`organization that is responsible for monitoring and mainte-
`nance of the MVPM can interrogate the data acquisition
`module of the MVPM. In this way a request for information
`flows over the wireless network through the CDMA module
`56 to interrogate 52 the data acquisition module 42 to
`provide information or to simply do a status check on the
`data acquisition module to insure that
`it
`is functioning
`appropriately. Alternatively, the data acquisition module can
`be reconfigured 54 to update communications capabilities,
`or to change the protocol for frequency of monitoring
`physiologic data and alarm limits.
`The system of the present invention includes the network
`and can allow any number of MVPMs.This system is only
`limited by the capacity of the wireless network to handle
`traffic. In the same fashion that a cellular telephone has a
`roaming capability, so does the MVPM,therefore allowing
`continual transmission and updating of physiologic data.
`Referring to FIG. 3, a front panel for the MVPM is
`illustrated. The MVPM hasa time of day 72 and a battery
`strength indicator 74 which allows the wearer to determine
`if recharging or battery replacementis required. The panel
`70 is dimensioned to be small and unobtrusive so that the
`
`wearer will not be disproportionately burdened by carrying
`the MPVM. The panel has several speed dialing preset
`buttons that allow emergencycalls to 911 76 to be made and
`to call the care provider 78 simply by the press of a button.
`Similarly,
`if the wearer determines that an “event” has
`occurred such as faintness, shortness of breath, irregular
`heartbeat, or other symptoms, this event button 80 can be
`pressed and a signal generated associated with the event. A
`powerindicator 82 is part of the panel so that the user can
`determine that poweris “on.” Scnsor lamp 86 is on the pancl
`as well to inform the user whetherall sensors are operating
`or if a sensor has potentially become disconnected or has
`otherwise malfunctioned. An alarm light 84 together with an
`audible signal is also present on the control panel sothat the
`patient can have both a visual and audible warning of any
`alarm condition that might exist.
`The panel design shown in this FIG. 3 is by way of
`illustration only. It will be apparentto those skilled in the art
`that other panel designs are possible so long as the infor-
`mation is presented in an easy and useable way for the
`patient.
`As noted above, the communications link between the
`MVPMand the care provider via the PSTN or the Internet
`is a bi-directional
`link. Thus requests for data from a
`workstation located at the care provider’s location can be
`transmitted through the Internet to the MVPM.Data transfer
`(real time or stored) can be transferred from the MVPM
`through the Internet to various data bases for analysis or
`storage. Data from the MVPMcanbetransferred in real time
`or from storage through the Internet to other authorized
`users such as insurance providers. Alarm information is
`transferred from the MVPMtothe care provider through the
`Internet or directly using a voice link. When a sensor
`malfunctions or becomes disconnected from the wearer, a
`“sensor off” signal is sent from the MVPM andtransferred
`over the Internet to the medical care provider so that such
`information is available and so that
`the paticnt can be
`notified. Event information, as described earlier, mayalso be
`transferred to the medical care provider. The medical care
`provider can transmit a communication to disarm or reset
`
`In addition to simply acquiring data, the data acquisition
`module 42 also notes any alarm condition 46 and transmits
`that information via CDMA module 56 to the internet where
`it can be accessed by medical care provider. In addition, data
`acquisition module 42 transmits the time of day 48 with any
`transmissionof alarm informationor bio sensor information.
`As noted earlier, the various alarm conditions can be recon-
`figured by the health care provider over the internet and the
`wireless network without any patient interaction.
`The CDMA module is for example one manufactured by
`Qualcomm for use with cellular telephone module. That
`information, in connection with 3Comm “QuickConnect”
`Internet connection software and 3Comm interworking
`function (IWF) device are all used to connect
`to, for
`example, the Sprint digital cellular telephone network. The ‘
`characteristics of the Qualcom CDMA cellular phone
`module, the 3Comm Quickconnect Internet connection soft-
`ware and the 3Com interworking function device are all
`incorporated herein by reference in their entirety.
`‘The CDMA module 56 allows tor digital cellular com-
`munications at 14.4 kbps which is sufficient for the trans-
`mission of the bio-sensor information contemplated by the
`present invention. This is not however meantas a limitation
`as further faster wireless modulated speeds will become
`available. All of these faster connections will be suitable for
`
`10
`
`15
`

`
`transmission of the data and voice of the present invention.
`Data that is collected is encrypted to prevent eavesdrop-
`ping or tampering with any commands. All information and
`data is Internet protocol compatible and contains error
`checking to insure data accuracy.
`The data acquisition module 42 continuously monitors,
`for example and without limitation, ECG andtransmitsthat
`information from the MVPMto the Internet. Transmission
`of data can be in real
`time and/or can be stored and
`forwarded depending upon the collection protocol ordered
`by the medical service provider. Similarly,
`temperature
`measurement, pulse oximetry, and pulse rate all can be
`collected and transmitted continuously during various peri-
`ods of time or can be collected stored and burst transmitted
`
`40
`
`45
`
`over the wireless network as required.
`‘The data acquisition module contains logic that allows an
`“alarm” condition to be transmitted at any time whenever
`the alarm characteristics are fulfilled. V'urther, any alarm
`condition can be reconfigured by the health care provider via
`the internet and thence over the wireless network,or directly
`over the wireless network. Any “sensor off’ signals, which
`are messages to both the patient and the medical service
`provider that, for example a sensor is turned off, broken, or
`has become disconnected 62 is sent upon occurrence. While
`such information is transmitted by the data acquisition
`module 42 to the CDMA module 56 and thence to the
`wireless network, a voice synthesizer 58 also provides a
`voice alert 60 to the patient that a particular alarm or sensor
`off condition has occurred.
`
`60
`
`As noted earlier the patient also has the ability to auto-
`matically dial 911 38 as needed. Data acquisition module 42
`also processes this information and passes it over a voice
`connection 50 to CDMA module 56 and thereafter to the
`wireless network for communication.
`
`65
`
`The patient also has the ability to call the medical care
`provider 40 on a non-emergencybasis. This is accomplished
`
`0007
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`US 6,443,890 B1
`
`7
`alarms in the MVPM through the Internet as necessary.
`Further protocols relating to when and the type of bio-signal
`to be measured can be sent from the medical provider to the
`Internet over the MVPM. The personal emergency button
`for use by the user to activate a call to the medical care
`provider gives voice communication from the MVPMto and
`from the care provider. Real-time clock resets or any other
`variations in configuration of the MVPM canbe transmitted
`from the medical care provider over the Internet
`to the
`MVPM.
`
`A wireless Internet bio-telemetry system has now been
`illustrated. It is important to note that, while a particular
`wireless protocol was described in the preferred embodi-
`ment (i.e. CDMA) this is not meant as a limitation. For
`example other protocols for communication in a wireless
`network such as GSM or a PCS network will be equally
`suitable for use with the present invention. It is also antici-
`pated that other types of wireless networks will also be
`suitable such as satellite networks and wireless local loop
`networks. The requirementis that there be two way com-
`munication with the MVPM andthat internet connectivity
`flow as part of the communication system to allow interac-
`tion between health care provider and the patient via voice
`and via the Internet. It will be apparent to those skilled in the
`art
`that other variations in,
`for example and without
`limitation, the type of network, the type of bio-sensor, and
`the configuration of the patient monitor can be accomplished
`without departing from the scope of the invention as dis-
`closed.
`We claim:
`1. Amethod for remotely monitoring a plurality of physi-
`ologic variables of a patient, comprising:
`mounting a single-site bio-sensor, which is integrally
`placed within a mold, in an ear of said patient in a
`mannerso asto allow sensing of signals representative
`of a plurality of physiologic variables of said patient;
`sending said signals to a battery-powered, patient-worn
`monitoring unit;
`processing said signals in said patient-worn monitoring
`unit to obtain processed data;
`transmitting said data over a digital cellular telephone
`network to a second network, wherein said transmitting
`is performed using a wireless communication device
`built into said patient-worn monitoring unit; and
`transmitting said data over said second network to a
`health care provider terminal for presentation to a
`health care provider,
`and further comprising:
`providing a microphone on said bio-sensor;
`acquiring voice data from said patient using said micro-
`phone; and
`transmitting said voice data to said health care provider
`over said digital cellular telephone network using said
`wireless communication device built into said patient-
`worn monitoring unit.
`2. The method of claim 1, wherein said bio-sensor is
`mounted so as to allow said patient to be ambulatory.
`3. The method of claim 1, wherein said second networkis
`the Internet.
`
`4. The method claim 1, further comprising:
`configuring a data collection protocol of said monitoring
`unit by communications from said healthcare provider
`terminal using said second network and said digital
`cellular telephone network.
`
`8
`is
`5. The method of claim 4, wherein said protocol
`selected from the group consisting of alarm limits, data
`collection frequency, and data transmission frequency.
`6. The method of claim 1, wherein said transmitting of
`said voice data to said health care provider comprises
`transmitting said voice data from said digital cellular tele-
`phone network to another network selected from the group
`consisting of: a public switched telephone network (PSTN)
`and an Internet.
`
`7. The method of claim 6, wherein said transmitting of
`said voice data is bi-directional so as to provide health care
`provider voice data to said patient.
`8. Asystem for remotely monitoring a plurality of physi-
`ologic variables of a patient, comprising:
`a single-site bio-sensor integrally placed within a mold
`and adapted to fit in an ear of said patient in a manner
`so as to allow sensing of signals representative of a
`plurality of physiologic variables of said patient;
`a battery-powered, patient-worn monitoring unit;
`meansfor sending said signals to said patient-worn moni-
`toring unit;
`means for processing said signals in said patient-worm
`monitoring unit to obtain processed data;
`a wireless communication device built into said patient-
`wor monitoring unit and configured to transmit said
`data over a digital cellular telephone network to a
`second network; and
`meansfor transmitting said data over said second network
`to a health care provider terminal for presentation to a
`health care provider, further comprising:
`a microphone on said bio-sensor;
`means for acquiring voice data from said patient using
`said microphone for supplying said voice data to said
`wireless communication device built into said patient-
`worn monitoring unit; and
`meansin said wireless communication device for trans-
`
`mitting said voice data to said health care provider over
`said digital cellular telephone network.
`9. The system of claim 8, whercin said bio-scnsor com-
`prises an ear-mounted sensorso as to allow said patient to
`be ambulatory.
`10. The system of claim 8, wherein said second network
`comprises the Internet.
`11. The system of claim 8, further comprising:
`means for configuring a data collection protocol of said
`monitoring unit by communications from said health-
`care provider terminal using said second network and
`said digital cellular telephone network.
`12. The system of claim 11, wherein said protocol is
`selected from the group consisting of alarm limits, data
`collection frequency, and data transmission frequency.
`13. The system of claim 8, wherein said means in said
`wireless communication device provides for transmitting of
`said voice data to said health care provider oversaid digital
`cellular telephone network and another network selected
`from the group consisting of: a PSTN and an Internet.
`14. The system of claim 13, wherein said meansin said
`wireless communication device is further adapted for
`bi-directional
`transmitting so as to provide health care
`provider voice data to said patient.
`*
`*
`*
`*
`
`%
`
`10
`
`15
`
`*
`
`40
`
`45
`
`60
`
`65
`
`0008
`
`0008
`
`

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