(12) United States Patent
`Causev, III et al.
`
`9
`
`USOO6641533B2
`(10) Patent No.:
`US 6,641,533 B2
`45) Date of Patent:
`*NOW. 4, 2003
`
`9
`
`(54) HANDHELD PERSONAL DATA ASSISTANT
`(PDA) WITH A MEDICAL DEVICE AND
`METHOD OF USING THE SAME
`(75) Inventors: James D. Causey, III, Simi Valley, CA
`(US); Richard E. Purvis, Pasadena, CA (30)
`(US); James L. Henke, Simi Valley,
`CA (US)
`(73) Assignee: Medtronic MiniMed, Inc., Northridge,
`CA (US)
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 56 days.
`
`(*) Notice:
`
`This patent is Subject to a terminal dis-
`claimer.
`
`(21) Appl. No.: 09/935,827
`(22) Filed:
`Aug. 23, 2001
`(65)
`Prior Publication Data
`
`US 2002/0002326 A1 Jan. 3, 2002
`O
`O
`Related U.S. Application Data
`
`(58) Field of Search ................................. 600/300-301,
`600/316, 347, 365; 128/903-904, 920;
`702/104; 379/106.1-106.2; 705/2-4; 340/573.1;
`604/66
`
`References Cited
`U.S. PATENT DOCUMENTS
`5,417,222 A 5/1995 Dempsey et al.
`5,507,288 A 4/1996 Bocker et al.
`5,961,451 A * 10/1999 Reber et al. ................ 600/322
`6.295,506 B1 * 9/2001 Heinonen et al. ........... 702/104
`FOREIGN PATENT DOCUMENTS
`O880936
`12/1998 ............ A61B/S/00
`EP
`9728736
`8/1997
`... A61B/S/00
`WO
`OO19887
`4/2000
`... A61B/S/00
`WO
`OO78210
`12/2000
`... A61B/S/00
`WO
`O128416
`4/2001
`............ A61B/S/00
`WO
`O128495
`4/2001
`WO
`O139089
`5/2001
`WO
`O152718
`7/2001
`WO
`o156154
`8/2001
`wo
`* cited by examiner
`Primary Examiner Max F. Hindenburg
`ASSistant Examiner Michael Astorino
`(74) Attorney, Agent, or Firm Medtronic MiniMed, Inc.
`(57)
`ABSTRACT
`
`........... GO6F/17/60
`
`(63) Sinai E. Neil Segny, A medical device module for use in a system with a remote
`filed on Aug. 19, 1999, and a continuation of application No.
`programmer and/O
`personal data assistant (PDA) with at
`09/334,996, filed on Jun. 17, 1999, which is a continuation
`least one medical device includes a housing, at least one
`of application No. 09/334,858, filed on Jun. 16, 1999, and a
`medical device and a processor. The housing is adapted to
`gif Epig3. 09/246,661, filed on Feb. 5,
`couple with the PDA. The at least one medical device
`now rat. No. 9.248,UD?.
`interface is coupled to the housing for interfacing with the at
`(60) Provisional application No. 60/103,812, filed on Oct. 8,
`1998, and provisional application No. 60/096,994, filed on
`least one medical device. The processor is coupled to the at
`Aug. 18, 1998.
`least one medical device interface to process data from the
`(51) Int. Cl." .................................................. Asip so test still. The processor is also capable of
`(52) U.S. Cl. ......................... 600/300; 600/316; 604/66;
`9.
`22 Claims, 17 Drawing Sheets
`128/897; 128/903
`
`
`
`Page 1 of 33
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`

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`U.S. Patent
`U.S. Patent
`
`Nov. 4, 2003
`Nov. 4, 2003
`
`Sheet 1 of 17
`Sheet 1 of 17
`
`US 6,641,533 B2
`US 6,641,533 B2
`
`
`
`
`
`F.G. 1
`FIG. 1
`
`Page 2 of 33
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`Page 2 of 33
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`U.S. Patent
`
`Nov. 4, 2003
`
`Sheet 2 of 17
`
`US 6,641,533 B2
`
`200
`
`
`
`FIG.2
`
`04
`
`24
`
`FIG. 3
`
`Page 3 of 33
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`

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`U.S. Patent
`U.S. Patent
`
`Nov. 4, 2003
`Nov. 4, 2003
`
`Sheet 3 of 17
`Sheet 3 of 17
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`US 6,641,533 B2
`US 6,641,533 B2
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`
`
`
`
`06 108 106
`106 108 106
`
`FIG. 4
`FIG. 4
`
`Page 4 of 33
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`Page 4 of 33
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`

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`U.S. Patent
`U.S. Patent
`
`Nov.4, 2003
`
`Sheet 4 of 17
`
`US 6,641,533 B2
`US 6,641,533 B2
`
`
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`
`
`
`FIG. 5
`FIG. 5
`
`Page 5 of 33
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`Page 5 of 33
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`

`

`U.S. Patent
`
`Nov. 4, 2003
`
`Sheet 5 of 17
`
`US 6,641,533 B2
`
`
`
`EEMEERED
`CHARACTERISTIC
`MONITOR
`TRANSMITTER
`
`
`
`100
`
`TELEMETERED
`CHAIRTC
`TRANSMER
`
`100
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`CHARACTERISTC N %
`
`TELEMETERED
`MONTOR
`TRANSMITTER
`
`1/2
`
`522
`
`CHARACTERISTIC
`METER
`
`FIG. 12
`
`660
`/
`
`
`
`400
`
`522
`
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`
`CHARACTERISTIC
`METER
`
`TELEMETERED
`CHARACTERISTIC
`MONOR
`TRANSMTER
`
`
`
`OO
`
`FIG. 13
`
`Page 6 of 33
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`

`

`U.S. Patent
`
`Nov. 4, 2003
`
`Sheet 6 of 17
`
`106108106
`
`US 6,641,533 B2
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`Page 7 of 33
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`Page 7 of 33
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`

`

`U.S. Patent
`
`Nov. 4, 2003
`
`Sheet 7 of 17
`
`US 6,641,533 B2
`
`TELEMETERED
`CHARACTERISTIC
`MONITOR
`TRANSMTER
`
`
`
`100
`
`
`
`RELAY / REPEATER
`
`MEDICAL
`DEVICE
`MODULE
`
`200
`
`
`
`
`
`
`
`
`
`
`
`
`
`FIG. 9
`
`COMPUTER
`
`
`
`
`
`COMMUNICATION
`SAON
`
`
`
`TELEMETERED
`CHARACTERISC
`MONTOR
`TRANSMER
`FIG. 10
`
`
`
`
`
`
`
`
`
`
`
`
`
`MEDICAL
`DEVICE
`MODULE
`
`
`
`
`
`
`
`SENSOR
`SE
`
`
`
`Page 8 of 33
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`

`

`U.S. Patent
`
`Nov. 4, 2003
`
`Sheet 8 of 17
`
`US 6,641,533 B2
`
`350
`
`Se
`NFUSION
`DEVICE N 400
`FIG. 14
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`a
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`NFUSION
`DEVICE
`FIG 16
`
`400
`
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`
`MEDICAL
`DEVICE
`
`a
`
`al
`
`-
`IMPANIABLE
`MEDICAL IN 622e
`DEVICE
`. . .
`.
`
`a
`
`a
`
`FIG. 17
`
`Page 9 of 33
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`

`

`U.S. Patent
`
`Nov. 4, 2003
`
`Sheet 9 of 17
`
`US 6,641,533 B2
`
`GO
`
`y 103
`
`S
`
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`utility
`
`RESERVOA
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`
`Page 10 of 33
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`

`

`U.S. Patent
`U.S. Patent
`
`Nov.4, 2003
`Nov. 4, 2003
`
`
`
`Sheet 10 of 17
`Sheet 10 Of 17
`
`US 6,641,533 B2
`
`US 6,641,533 B2
`
`Page 11 of 33
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`Page 11 of 33
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`

`

`U.S. Patent
`
`Nov. 4, 2003
`
`Sheet 11 Of 17
`
`US 6,641,533 B2
`
`PER
`
`BOS
`
`--
`
`6.
`
`
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`
`RF DEVICE
`
`
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`PROGRAER
`
`O2
`
`Page 12 of 33
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`

`

`U.S. Patent
`
`Nov. 4, 2003
`
`Sheet 12 of 17
`
`US 6,641,533 B2
`
`
`
`
`
`RFPROGRAER
`
`12
`
`
`
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`EYE
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`
`:
`()
`
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`
`AFPROGRAMMER N.
`
`FIG. 27
`
`Page 13 of 33
`
`

`

`U.S. Patent
`
`Nov. 4, 2003
`
`Sheet 13 of 17
`
`US 6,641,533 B2
`
`TELEMETERED
`CHARACTERISTIC
`MONTOR
`TRANSMITTER
`
`200
`
`RELAY / REPEATER
`
`CHARACTERISTIC
`MONITOR
`
`2200
`
`
`
`
`
`
`
`
`
`FIG. 28
`
`
`
`
`
`COMPUTER
`
`2006
`
`
`
`
`
`
`
`
`
`
`
`CHARACTERISTIC
`MONOR
`
`COMMUNICATION
`STATION
`
`
`
`
`
`TELEMETERED
`CHARACTERISC
`MONOR
`TRANSMER
`FIG. 29
`
`SENSOR
`SE
`
`Page 14 of 33
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`

`

`U.S. Patent
`
`Nov. 4, 2003
`
`Sheet 14 of 17
`
`US 6,641,533 B2
`
`2010
`
`2200
`
`2 go
`
`f
`
`ROM
`
`KEYPAD
`
`
`
`2202
`
`MCROPROCESSOR
`
`226
`
`DATANPUT
`AND OUTPUT 2210
`
`SENSOR
`MONTOR
`
`2212
`
`
`
`BATERY
`AND
`POWER SUPPLY
`
`228
`
`:
`
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`
`:
`
`CHARACTERISTIC
`ES
`METER
`2304
`
`SENSOR
`INTERFACE N2214
`
`SENSOR
`CONNECTOR
`
`2180
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`
`
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`2150
`
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`2300-
`
`TES
`INTERFACE
`!------- --------
`
`
`
`
`
`
`
`TEST STRIP
`AND
`SAMPLE
`
`2350
`
`FIG. 30
`
`Page 15 of 33
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`

`

`U.S. Patent
`U.S. Patent
`
`Nov.4, 2003
`Nov. 4, 2003
`
`Sheet 15 of 17
`Sheet 15 Of 17
`
`US 6,641,533 B2
`US 6,641,533 B2
`
`200
`2010
`
`
`
`2350
`
`2350
`
`FIG. 31
`FIG. 31
`
`Page 16 of 33
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`Page 16 of 33
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`

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`U.S. Patent
`U.S. Patent
`
`Nov.4, 2003
`Nov. 4, 2003
`
`Sheet 16 of 17
`Sheet 16 0f 17
`
`US 6,641,533 B2
`US 6,641,533 B2
`
`2350
`2350
`
`2010
`2010
`t
`
`{
`
`
`
`FIG. 32
`FIG. 32
`
`2150
`
`2180 /
`
`Page 17 of 33
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`Page 17 of 33
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`

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`U.S. Patent
`
`Nov.4, 2003
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`US 6,641,533 B2
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`Sheet 17 of 17
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`Page 18 of 33
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`Page 18 of 33
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`

`

`1
`HANDHELD PERSONAL DATA ASSISTANT
`(PDA) WITH A MEDICAL DEVICE AND
`METHOD OF USING THE SAME
`
`RELATED APPLICATIONS
`This is a continuation of U.S. patent application Ser. No.
`09/487,423 filed Jan. 20, 2000, which is a continuation of
`U.S. patent application Ser. No. 09/334,858 filed Jun. 16,
`1999 that claims priority on U.S. Provisional Application
`Ser. No. 60/096,994 filed Aug. 18, 1998, a continuation of
`U.S. patent application Ser. No. 09/377,472 filed Aug. 19,
`1999 that claims priority on U.S. Provisional Application
`Ser. No. 60/103,812 filed Oct. 8, 1998, a continuation of
`U.S. patent application Ser. No. 09/334,996 filed Jun. 17,
`1999, and a continuation of U.S. patent application Ser. No.
`09/246,661 filed Feb. 5, 1999- now U.S. Pat. No 6,248,067,
`all of which are herein specifically incorporated by reference
`in their entirety.
`FIELD OF THE INVENTION
`This invention relates to remote programmerS and/or
`handheld personal data assistants (PDA) for use with medi
`cal devices and, in particular embodiments, to a PDA that
`includes a medical device to facilitate testing and monitoring
`of a patient's condition with coordination of data manage
`ment and programming through the PDA.
`BACKGROUND OF THE INVENTION
`Over the years, bodily characteristics have been deter
`mined by obtaining a Sample of bodily fluid. For example,
`diabetics often test for blood glucose levels with a blood
`glucose meter. Traditional blood glucose determinations
`have utilized a painful finger Stick using a lancet to withdraw
`a Small blood Sample that is used by the blood glucose meter.
`This results in discomfort from the lancet as it contacts
`nerves in the Subcutaneous tissue. To obtain a measure of
`control or information on a diabetic's condition, Several
`finger Sticks and tests are required each day (8 or more Such
`tests a day are not uncommon). The pain of lancing and the
`cumulative discomfort from multiple needle StickS is a
`Strong reason why patients fail to comply with a medical
`testing regimen used to determine a change in characteristic
`over a period of time. In addition, these blood glucose
`meters are only designed to provide data at discrete points,
`and even with multiple tests a day, do not provide continu
`ous data to Show the variations in the characteristic between
`testing times.
`A variety of implantable electrochemical Sensors for use
`with monitors have been developed for detecting and/or
`quantifying Specific agents or compositions in a patient's
`blood. For instance, glucose Sensors have been developed
`for use in obtaining an indication of blood glucose levels in
`a diabetic patient. Such readings are useful in monitoring
`and/or adjusting a treatment regimen which typically
`includes the regular administration of insulin to the patient.
`Thus, blood glucose readings from the monitor improve
`medical therapies with Semi-automated medication infusion
`pumps of the external type, as generally described in U.S.
`Pat. Nos. 4,562,751; 4,678,408; and 4,685,903; or auto
`mated implantable medication infusion pumps, as generally
`described in U.S. Pat. No. 4,573,994, which are herein
`incorporated by reference. Typical thin film Sensors are
`described in commonly assigned U.S. Pat. Nos. 5,390,671;
`5,391,250; 5,482,473; and 5,586,553 which are incorporated
`by reference herein. See also U.S. Pat. No. 5,299,571.
`However, the monitors and electrochemical Sensors often
`
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`US 6,641,533 B2
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`2
`require calibration using readings obtained from blood glu
`cose meters to augment and adjust for drift over time. Thus,
`although the monitors and electrochemical Sensors provide
`more accurate trend information, a separate blood glucose
`meter is still often required.
`A user must often carry multiple devices to test different
`aspects of the same value or characteristic. For instance, the
`a user would need a blood glucose meter and blood glucose
`monitor. In addition, individuals are also carrying other
`electronic devices, Such as an infusion device, cellular
`telephones, personal entertainment Systems (such as radios,
`cassette players, CD players, or the like). They may also
`include Small personal computers, personal data assistants
`(PDAs) or the like. Thus, users often carry a large number
`of Separate electronic devices, which can be cumberSome
`and inconvenient to handle.
`
`SUMMARY OF THE DISCLOSURE
`It is an object of an embodiment of the present invention
`to provide an improved remote programmer and/or personal
`data assistant (PDA) that includes a characteristic monitor
`and/or a characteristic meter, which obviates for practical
`purposes, the above mentioned limitations.
`According to an embodiment of the present invention a
`remote programmer for interfacing with at least one medical
`device includes at least one medical device module, at least
`one processor, a housing, at least one input/output port, at
`least one display, at least one button, at least one audio
`indication device and at least one portable power Supply.
`The at least one medical device module is operatively
`coupled with the remote programmer and includes at least
`one medical device interface to interface with the at least one
`medical device. The at least one processor is to interface
`with the remote programmer and is coupled to the at least
`one medical device interface to process data from the at least
`one medical device. The housing is adapted to contain the
`medical device module and the at least one processor. The at
`least one input/output port is for communicating with the at
`least one medical device. The at least one display includes
`at least one touch Screen element to interface with the at least
`one of the at least one processor and the at least one medical
`device. The at least one button is to interface with at least
`one of the at least one processor and the at least one medical
`device, and the at least one audio indication device is
`coupled to the at least one processor to provide an audio
`indication. The at least one portable power Supply is con
`tained within the housing of the remote programmer to
`provide power to at least one of the at least one processor
`and the at least one medical device. In still further
`embodiments, the at least one medical device is an infusion
`device, a characteristic monitor, a characteristic meter, an
`analyte Sensor patch and/or more than one medical device.
`In other embodiments, the remote programmer is personal
`data assistant (PDA).
`In particular embodiments, the at least one medical device
`module has a separate housing that is adapted to couple with
`the housing of the remote programmer. In other
`embodiments, the at least one medical device is a charac
`teristic Sensor that produces a signal indicative of a charac
`teristic of a user, and further includes a Second characteristic
`determining device. The Second characteristic determining
`device is within the housing for receiving and testing an
`analyte to determine the quantity of the analyte indepen
`dently of the at least one characteristic Sensor. The at least
`one medical device interface is a Sensor receiver to receive
`Sensor data Signals produced from the at least one charac
`
`Page 19 of 33
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`

`3
`teristic Sensor, and the at least one processor is coupled to
`the Sensor receiver and the Second characteristic determining
`device to process the determined quantity of the analyte
`from the Second characteristic determining device and the
`Sensor data Signals from the at least one characteristic
`Sensor. In further embodiments, the at least one character
`istic Sensor is remotely located from the at least one medical
`device module, and the Sensor receiver receives the Sensor
`data Signals as wireleSS Signals from the remotely located at
`least one characteristic Sensor.
`In other embodiments, the remote programmer further
`includes a transmitter coupled to the at least one processor
`and the input/output port for transmitting the processed
`Sensor data Signals to another data receiving device. In
`additional embodiments, the at least one medical device
`module uses the display of the remote programmer to Show
`the determined quantity of the analyte from the Second
`characteristic determining device and the processed Sensor
`data Signals from the at least one characteristic Sensor. Also,
`the at least one processor monitors the Sensor data Signals
`from the Sensor receiver to determine when the Second
`characteristic determining device is to be used to perform
`calibration of the Sensor data Signals. In yet other
`embodiments, the remote programmer further includes at
`least one memory to Store the determined quantity of the
`analyte from the Second characteristic determining device
`and the processed Sensor data Signals from the at least one
`characteristic Sensor. In particular embodiments, the Sensor
`data Signals are received by the Sensor receiver continuously,
`near continuously or intermittently. In other embodiments,
`the Second characteristic determining device is a Second
`medical device module that utilizes a Second characteristic
`Sensor. In these embodiments, the determined quantity of the
`analyte from the Second characteristic determining device is
`determined continuously, near continuously or intermit
`tently.
`In further embodiments of the present invention, the
`Second medical device module and the Second characteristic
`Sensor use a different Sensing technology from that used by
`the at least one medical device module and the characteristic
`Sensor. In addition, the Second characteristic determining
`device utilizes a discrete Sample to determine the quantity of
`the analyte. Also, the Second characteristic determining
`device may utilize a test Strip to analyze the Sample to
`determine the quantity of the analyte.
`In yet further embodiments, the remote programmer fur
`ther includes a transmitter coupled to the at least one
`processor and the input/output port. The the at least one
`processor further includes the ability to program other
`medical devices, and the transmitter transmits a program to
`the other medical devices. In particular embodiments, the
`transmitter transmits through a relay device between the
`transmitter and a remotely located processing device. In
`Some embodiments, the relay device increases a maximum
`distance by amplifying the processed Sensor data Signals
`from the transmitter to be received by the remotely located
`processing device. In other embodiments, the relay device
`enables the remotely located processing device to be located
`in a different room than the transmitter. While in other
`embodiments, the relay device includes a telecommunica
`tions device, and when the transmitter generates an alarm the
`telecommunications device transmits the alarm to a remotely
`located receiving Station. Further embodiments of the
`remote programmer include a data receiver, and the data
`receiver receives program instructions from other proceSS
`ing devices.
`In additional embodiments, a medical device module for
`use in a System with the at least one medical device and the
`
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`US 6,641,533 B2
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`4
`remote programmer includes a module housing, the at least
`one medical device interface and at least one module pro
`ceSSor. The module housing is adapted to couple with the
`housing of the remote programmer. The at least one medical
`device interface is coupled to the module housing for
`interfacing with the at least one medical device. The at least
`one module processor is coupled to the at least one medical
`device interface to process data from the at least one medical
`device, and wherein the at least one module processor is
`capable of interfacing with the at least one processor of the
`remote programmer.
`In more embodiments, the at least one medical device is
`a characteristic Sensor that produces a signal indicative of a
`characteristic of a user, and the medical device module
`further includes a Second characteristic determining device.
`The Second characteristic determining device is within the
`housing for receiving and testing an analyte to determine the
`quantity of the analyte independently of the at least one
`characteristic Sensor. The the at least one medical device
`interface is a Sensor receiver to receive Sensor data Signals
`produced from the at least one characteristic Sensor, and the
`at least one module processor is coupled to the Sensor
`receiver and the Second characteristic determining device to
`process the determined quantity of the analyte from the
`Second characteristic determining device and the Sensor data
`Signals from the at least one characteristic Sensor.
`According to a further embodiment of the present
`invention, a medical device module for use in a System with
`a personal data assistant (PDA) with at least one medical
`device includes a housing, at least one medical device and
`a processor. The housing is adapted to couple with the PDA.
`The at least one medical device interface is coupled to the
`housing for interfacing with the at least one medical device.
`The processor is coupled to the at least one medical device
`interface to proceSS data from the at least one medical
`device. The processor is also capable of interfacing with the
`PDA.
`In preferred embodiments, the at least one medical device
`is a characteristic Sensor that produces a signal indicative of
`a characteristic of a user, and the medical device module
`further includes a Second characteristic determining device
`within the housing for receiving and testing an analyte to
`determine the quantity of the analyte independently of the at
`least one characteristic Sensor. The at least one medical
`device interface is a Sensor receiver to receive Sensor data
`Signals produced from the at least one characteristic Sensor.
`The processor is coupled to the Sensor receiver and the
`Second characteristic determining device to process the
`determined quantity of the analyte from the Second charac
`teristic determining device and the Sensor data Signals from
`the at least one characteristic Sensor.
`In particular embodiments, the at least one characteristic
`Sensor is remotely located from the medical device module,
`and the Sensor receiver receives the Sensor data Signals as
`wireleSS Signals from the remotely located at least one
`characteristic Sensor. In other embodiments, the medical
`device module further includes a transmitter coupled to the
`processor for transmitting the processed Sensor data Signals
`to another data receiving device. In additional embodiments,
`the medical device module uses a display of the PDA to
`show the determined quantity of the analyte from the Second
`characteristic determining device and the processed Sensor
`data Signals from the at least one characteristic Sensor. In
`further embodiments, the processor monitors the Sensor data
`Signals from the Sensor receiver to determine when the
`Second characteristic determining device is to be used to
`perform calibration of the Sensor data Signals.
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`In other embodiments, the medical device module further
`includes a memory to Store the determined quantity of the
`analyte from the Second characteristic determining device
`and the processed Sensor data Signals from the at least one
`characteristic Sensor. In Still other embodiments, the Sensor
`data Signals are received by the Sensor receiver continuously,
`near continuously or intermittently.
`In yet another embodiments, the Second characteristic
`determining device is a Second medical device module that
`utilizes a Second characteristic Sensor. In these
`embodiments, the determined quantity of the analyte from
`the Second characteristic determining device is determined
`continuously, near continuously or intermittently. In a fur
`ther embodiment, the Second medical device module and the
`Second characteristic Sensor use a different Sensing technol
`ogy from that used by the at least one medical device module
`and the characteristic Sensor.
`In Still yet another embodiment of the present invention,
`the Second characteristic determining device utilizes a dis
`crete Sample to determine the quantity of the analyte. In
`further embodiments, the Second characteristic determining
`device utilizes a test Strip to analyze the Sample to determine
`the quantity of the analyte. In still further embodiments, the
`at least one medical device is an infusion device, an analyte
`Sensor patch and/or more than one medical device.
`Still other preferred embodiments of the present invention
`are directed to a personal data assistant (PDA) for interfac
`ing with at least one medical devices described above. In
`these embodiments, the medical device module operatively
`couples with the PDA and the PDA includes a housing
`adapted to receive the medical device module.
`Further preferred embodiments of the present invention
`are directed to a medical device module for use in a System
`with a personal data assistant (PDA) with at least one
`characteristic Sensor that produces a Signal indicative of a
`characteristic of a user. The medical device module includes
`a housing, a test Strip receptacle, a Sensor receiver and a
`processor. The housing is adapted to operatively couple with
`the PDA. The test Strip receptacle for receiving and testing
`a test Strip exposed to an analyte to determine the quantity
`of the analyte. The Sensor receiver is for receiving Sensor
`data Signals produced from the at least one characteristic
`Sensor. The processor is coupled to the Sensor receiver and
`the test Strip receptacle to process the determined quantity of
`the analyte from the test Strip receptacle and the Sensor data
`Signals from the at least one characteristic Sensor, and the
`processor is capable of interfacing with the PDA.
`In particular embodiments, the at least one characteristic
`Sensor is remotely located from the medical device module,
`and wherein the Sensor receiver receives the Sensor data
`Signals as wireleSS Signals from the remotely located at least
`one characteristic Sensor. In other embodiments, the medical
`device module further includes a transmitter coupled to the
`processor for transmitting the processed Sensor data Signals
`to another data receiving device. Preferably, the transmitter
`transmits the processed Sensor Signals by radio frequencies.
`In additional embodiments, the transmitter transmits through
`a relay device between the transmitter and a remotely
`located processing device. Preferably, the relay device
`increases a maximum distance by amplifying the processed
`Sensor data Signals from the transmitter to be received by the
`remotely located processing device. Alternatively, the relay
`device enables the remotely located processing device to be
`located in a different room than the transmitter. In other
`alternative embodiments, the relay device includes a tele
`communications device, and when the transmitter generates
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`an alarm the telecommunications device transmits the alarm
`to a remotely located receiving Station.
`In further embodiments, the processor of the medical
`device module further includes the ability to program other
`medical devices, and wherein the transmitter transmits a
`program to the other medical devices. In Still other
`embodiments, the medical device module further includes a
`data receiver, and the data receiver receives program instruc
`tions from other processing devices.
`In yet another embodiment, the medical device module
`uses a display on the PDA to show the determined quantity
`of the analyte from the test Strip receptacle and the processed
`Sensor data Signals from the at least one characteristic
`Sensor. In Still other embodiments, the processor of the
`medical device module the Sensor data Signals from the
`Sensor receiver to determine when the test receptacle is to be
`used to perform calibration of the Sensor data Signals.
`Additional embodiments of the medical device module
`further include a memory to Store the determined quantity of
`the analyte from the test Strip receptacle and the processed
`Sensor data Signals from the at least one characteristic
`Sensor. In particular embodiments, the Sensor data Signals
`are received by the Sensor receiver continuously, near con
`tinuously or intermittently.
`Other features and advantages of the invention will
`become apparent from the following detailed description,
`taken in conjunction with the accompanying drawings which
`illustrate, by way of example, various features of embodi
`ments of the invention.
`BRIEF DESCRIPTION OF THE DRAWINGS
`A detailed description of embodiments of the invention
`will be made with reference to the accompanying drawings,
`wherein like numerals designate corresponding parts in the
`Several figures.
`FIG. 1 is a perspective view of a System using a handheld
`data assistant (PDA) and computer in accordance with an
`embodiment of the present invention.
`FIG. 2 is a perspective view of a PDA with a medical
`device module in accordance with an embodiment of the
`present invention.
`FIG. 3 is a bottom plan view of the PDA and medical
`device shown in FIG. 2.
`FIG. 4 is a perspective view of the PDA including a
`medical device module that includes a characteristic monitor
`and characteristic meter and that interfaces with a teleme
`tered characteristic monitor transmitter in accordance with a
`first embodiment of the present invention.
`FIG. 5 is a block diagram of the medical device module
`that includes the characteristic monitor and the characteristic
`meter shown in FIG. 4.
`FIG. 6 is a perspective view of the medical device module
`that includes the characteristic meter and characteristic
`monitor that interfaces with a telemetered characteristic
`monitor transmitter in accordance with the embodiment of
`FIGS. 4 and 5.
`FIG. 7 is a perspective view of a PDA including a medical
`device module that includes a characteristic meter, charac
`teristic monitor that interfaces with a telemetered character
`istic monitor transmitter, and an infusion device in accor
`dance with a Second embodiment of the present invention.
`FIG. 8 is a perspective view of the medical device module
`that includes the characteristic meter and characteristic
`monitor that interfaces with a telemetered characteristic
`monitor transmitter and interfaces with the infusion device
`in accordance with the embodiment of FIG. 7.
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`FIG. 9 is a simplified block diagram of a telemetered
`characteristic monitor transmitter and medical device mod
`ule in accordance with a third embodiment of the present
`invention.
`FIG. 10 is a simplified block diagram of a telemetered
`characteristic monitor transmitter and medical device mod
`ule System in accordance with a fourth embodiment of the
`present invention.
`FIG. 11 is a perspective view of a medical device module
`that interfaces with a telemetered characteristic monitor
`transmitter in accordance with a fifth embodiment of the
`present invention.
`FIG. 12 is a perspective view of a medical device module
`that interfaces with a characteristic meter in accordance with
`a sixth embodiment of the present invention.
`FIG. 13 is a perspective view of a medical device module
`that interfaces with an infusion device, telemetered charac
`teristic monitor transmitter and a characteristic meter in
`accordance with a Seventh embodiment of the present inven
`tion.
`FIG. 14 is a perspective view of a medical device module
`that includes a characteristic meter and interfaces with an
`infusion device in accordance with an eighth embodiment of
`the present invention.
`FIG. 15 is a perspective view of a medical device module
`that includes a characteristic meter in accordance with a
`ninth embodiment of the present invention.
`FIG. 16 is a perspective view of a medical device module
`that interfaces with an infusion device in accordance with a
`tenth embodiment of the present invention.
`FIG. 17 is a perspective view of a medical device module
`that interfaces with an implantable medical device in accor
`dance with a tenth embodiment of the present invention.
`FIG. 18 is a perspective view of a medical device module
`that includes a input jack for a wired connection with a
`medical device in accordance with an eleventh embodiment
`of the present invention.
`FIG. 19 is a perspective view of a medical device module
`that interfaces with an implantable analyte Sensing patch in
`accordance with a twelfth embodiment of the present inven
`tion.
`FIG. 20 is a perspective view of a medical device module
`that includes contacts for interfacing with a medical device
`in accordance with a thirteenth embodiment of the present
`invention.
`FIG. 21 is a simplified block diagram of an external
`infusion device and System in accordance with an embodi
`ment of the present invention.
`FIG. 22 is a perspective view of an external infusion
`device and System in accordance with an embodiment of the
`present invention.
`FIG. 23 is a top perspective view of an RF programmer
`in accordance with an embodiment of the present invention.
`FIG. 24 is a top perspective View of a remote commander
`in accordance with another embodiment of the pres