(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2004/0122353 A1
`(43) Pub. Date:
`Jun. 24, 2004
`Shahmirian et al.
`
`US 2004O122353A1
`
`(54) RELAY DEVICE FORTRANSFERRING
`INFORMATION BETWEEN A SENSOR
`SYSTEMAND AFLUID DELIVERY SYSTEM
`(75) Inventors: Varaz Shahmirian, Northridge, CA
`(US); Wayne A. Morgan, Northridge,
`CA (US); Sheldon B. Moberg,
`Thousand Oaks, CA (US); Cary D.
`Talbot, Santa Clarita, CA (US); Arthur
`A. Campbell, Stevenson Ranch, CA
`(US); Jay A. Yonemoto, Arcadia, CA
`(US)
`Correspondence Address:
`MEDTRONIC MINIMED INC.
`18000 DEVONSHIRE STREET
`NORTHRIDGE, CA 91325-1219 (US)
`(73) Assignee: MEDTRONIC MINIMED, INC.
`(21) Appl. No.:
`10/335,256
`(22) Filed:
`Dec. 31, 2002
`Related U.S. Application Data
`(60) Provisional application No. 60/435,337, filed on Dec.
`19, 2002.
`
`
`
`Publication Classification
`
`(51) Int. Cl. ................................................... G05D 7/00
`(52) U.S. Cl. ............................. 604/65; 700/282; 128/920
`
`(57)
`
`ABSTRACT
`
`A relay device transferS information between a Sensor Sys
`tem, which measures a physiological characteristic level of
`a user, and a fluid delivery System, which infuses a fluid into
`a user. The relay device includes a Sensor System receiver for
`receiving communications from the Sensor System in a
`Sensor System format. The relay device also includes a
`processor for processing the communications from the Sen
`Sor System and converting the communications for trans
`mission in a delivery system format. The relay device further
`includes a delivery System transmitter for transmitting the
`converted communications in the delivery System format to
`the fluid delivery system. The sensor system and delivery
`System formats may utilize different frequencies and/or
`different communication protocols for communications
`transmitted between the sensor system and the fluid delivery
`System through the relay device.
`
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`Jun. 24, 2004
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`RELAY DEVICE FORTRANSFERRING
`INFORMATION BETWEEN A SENSOR SYSTEM
`AND A FLUID DELIVERY SYSTEM
`
`RELATED APPLICATIONS
`0001. This application claims priority on U.S. Provi
`sional Patent Application filed Dec. 19, 2002 and entitled
`“Relay Device for Transferring Information Between a
`Sensor System and a Fluid Delivery System,” which is
`herein Specifically incorporated by reference.
`
`BACKGROUND OF THE INVENTION
`0002 Ambulatory pumps and hospital-based fluid deliv
`ery systems are used to deliver fluids into the bodies of
`patients. For Some therapies, Sensor measurements of a
`patient's physiological characteristics are used to calculate
`fluid dosage requirements. Typically, a Sensor monitor is
`used to collect Sensor data from a Sensor, calibrate the Sensor
`data to generate Sensor measurements, and display the
`Sensor measurements. Next, the patient or a caregiver manu
`ally calculates the required fluid dosage based on the dis
`played Sensor measurements. Finally, the patient or car
`egiver programs the pump or fluid delivery System to adjust
`the fluid dosage.
`0.003
`For example, patients with Type 1 diabetes and
`Some patients with Type 2 diabetes use insulin to control
`their blood glucose (BG) level. Typically, if a patient's BG
`level is too high, the patient can inject a “bolus' (dose) of
`insulin to lower his/her BG level from its present level to a
`desired target level. Furthermore, the patient may inject a
`bolus of insulin in anticipation of ingesting carbohydrates,
`thus heading off a sharp rise in his/her BG level. Presently,
`a patient or caregiver must measure the patient's blood
`glucose using a BG monitoring System, Such as a continuous
`glucose measurement System, a test Strip meter, a hospital
`based measurement System, or an automated intermittent
`blood glucose measurement system. When the BG monitor
`ing System has generated a BG measurement, the BG
`measurement is displayed on the BG monitoring System.
`Next, the patient or caregiver must visually read and then
`utilize the BG measurement to manually calculate a required
`insulin bolus (i.e., the amount of insulin to inject). Finally,
`once the required insulin bolus is calculated, the patient or
`caregiver must utilize an insulin delivery device (e.g., infu
`Sion pump, injection pen, IV meter, or the like) to deliver the
`insulin bolus into the patient’s body.
`0004.
`Unfortunately, this process requires the patient or
`caregiver to handle Several pieces of equipment, including
`the BG monitoring System and the insulin delivery device,
`which may discourage the patient or caregiver from using
`the BG measurements to adjust the insulin dosage, and thus,
`decrease the efficacy of the insulin delivery device. Addi
`tionally, if the BG monitoring system and the insulin deliv
`ery device are not developed in conjunction with one
`another, they typically communicate using different frequen
`cies and/or modes of communication, and as a result, cannot
`communicate directly with one another. Thus, the patient or
`caregiver must manually calculate the required insulin bolus
`and program the insulin delivery device accordingly, which
`requires effort by the patient or caregiver and is Subject to
`calculation errors. Alternatively, the patient or caregiver
`must manually enter the BG measurement into an electronic
`
`computing device with bolus estimation Software for calcu
`lating the required insulin bolus (e.g., a computer, the
`Internet, a personal digital assistant (PDA), or an insulin
`delivery device, Such as an infusion pump, injection pen, IV
`meter, or the like), which also requires effort by the patient
`or caregiver and is Subject to transcription errors. For
`example, the patient or caregiver may not accurately enter
`the BG measurement that is displayed on the BG measure
`ment device into the electronic computing device, and thus,
`the resulting bolus estimate calculation may not be accurate.
`
`SUMMARY OF THE INVENTION
`0005. It is an object of an embodiment of the present
`invention to provide an improved infusion System including
`a relay device for transferring information between a Sensor
`system and a fluid delivery system, which obviates for
`practical purposes, the above mentioned limitations.
`0006 According to an embodiment of the invention, an
`infusion System for infusing a fluid into a user includes a
`Sensor System, a relay device, and a delivery System. The
`Sensor System includes a Sensor System housing, a Sensor
`coupled to the Sensor System housing for producing a signal
`indicative of a physiological characteristic level of the user,
`a Sensor System processor contained in the Sensor System
`housing for processing the Signal indicative of the physi
`ological characteristic level of the user, and a Sensor System
`transmitter contained in the Sensor System housing and
`coupled to the Sensor System processor for transmitting one
`or more communications in a Sensor System format. The
`relay device includes a relay device receiver for receiving
`the communications from the Sensor System in the Sensor
`System format, a relay device processor for processing the
`communications from the Sensor System and converting the
`communications for transmission in a delivery System for
`mat, and a relay device transmitter for transmitting the
`converted communications in the delivery System format.
`The fluid delivery system includes a delivery system hous
`ing, a delivery System receiver contained in the delivery
`System housing for receiving the communications from the
`relay device in the delivery System format, and a delivery
`System processor contained in the delivery System housing
`and coupled to the delivery System receiver for processing
`the communications from the relay device in the delivery
`System format and controlling an amount of the fluid infused
`into the user. Further, the amount of the fluid infused into the
`user is determined based upon data indicative of the physi
`ological characteristic level of the user.
`0007. In particular embodiments, at least one of the
`communications transmitted from the Sensor System through
`the relay device and received by the fluid delivery system
`include data indicative of the physiological characteristic
`level of the user. Additionally, the communications includ
`ing the data indicative of the physiological characteristic
`level of the user may be automatically transmitted from the
`Sensor System through the relay device and received by the
`fluid delivery system. Further, the fluid delivery system may
`also include a display device contained in the delivery
`System housing and coupled to the delivery System proces
`Sor for automatically displaying to the user the data indica
`tive of the physiological characteristic level of the user.
`Alternatively, the fluid delivery system may further include
`a display device contained in the delivery System housing
`and coupled to the delivery System processor for displaying
`
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`Jun. 24, 2004
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`data to the user, and a user interface contained in the housing
`and coupled to the delivery System processor for accepting
`one or more inputs from the user. At least one of the inputs
`may cause the display device to display the data indicative
`of the physiological characteristic level of the user received
`by the fluid delivery system. Also, the user interface may be
`dedicated for interfacing with the data indicative of the
`physiological characteristic level of the user received by the
`fluid delivery system.
`0008. In other particular embodiments, the fluid delivery
`System includes a memory contained in the delivery System
`housing for Storing the data indicative of the physiological
`characteristic level of the user received by the fluid delivery
`System. Also, the fluid delivery System may include a
`display device contained in the housing and coupled to the
`delivery System processor for displaying to the user a
`historical trend or graph using the Stored data indicative of
`the physiological characteristic level of the user received by
`the fluid delivery system.
`0009. In still other particular embodiments, the fluid
`delivery System may include a display device contained in
`the delivery System housing and coupled to the delivery
`System processor for displaying data to the user, and a user
`interface contained in the delivery System housing and
`coupled to the delivery System processor for accepting one
`or more inputs from the user. At least one of the inputs may
`cause the display device to display the most recent data
`indicative of the physiological characteristic level of the user
`received by the fluid delivery System. Also, at least a portion
`of the user interface may be dedicated for interfacing with
`the data indicative of the physiological characteristic level of
`the user received by the fluid delivery system.
`0010. In yet other particular embodiments, the fluid
`delivery System includes a display device contained in the
`delivery System housing and coupled to the delivery System
`processor for displaying data to the user, and a user interface
`contained in the delivery System housing and coupled to the
`delivery System processor for accepting one or more inputs
`from the user. At least one of the inputs causes the display
`device to display the data indicative of the physiological
`characteristic level of the user received by the fluid delivery
`System. Further, at least a portion of the user interface may
`be dedicated for interfacing with the data indicative of the
`physiological characteristic level of the user received by the
`fluid delivery system.
`0011. In still other embodiments, the fluid delivery sys
`tem includes a user interface for accepting one or more
`inputs from the user, and the user interface is contained in
`the delivery System housing and coupled to the delivery
`System processor. At least one of the inputs programs the
`amount of the fluid infused into the user based upon the data
`indicative of the physiological characteristic level of the user
`received by the fluid delivery system. In yet other embodi
`ments, the fluid delivery System includes a bolus estimator
`used in conjunction with the delivery System processor for
`estimating the amount of the fluid to be infused into the user
`based upon the data indicative of the physiological charac
`teristic level of the user received by the fluid delivery
`System, an indication device coupled to the bolus estimator
`for indicating the estimated amount of fluid to be infused
`into the user, and a user interface for accepting one or more
`inputs from the user. At least one of the inputs accepts or
`
`modifies the estimated amount of the fluid to be infused into
`the user. In additional embodiments, the fluid delivery
`System includes a closed loop algorithm executed by the
`delivery System processor for automatically determining the
`amount of the fluid to be infused into the user based upon the
`data indicative of the physiological characteristic level of the
`user received by the fluid delivery System and causing the
`fluid delivery system to infuse the determined amount of the
`fluid into the user. In further embodiments, the fluid delivery
`System includes an indication device for indicating when the
`data indicative of the physiological characteristic level of the
`user received by the fluid delivery system is above or below
`a target characteristic value.
`0012. In still additional embodiments, the fluid delivery
`System includes a delivery System transmitter contained in
`the delivery System housing and coupled to the delivery
`System processor for transmitting one or more communica
`tions in the delivery system format. The relay device
`receiver further receives the communications from the fluid
`delivery System in the delivery System format, the relay
`device processor processes the communications from the
`fluid delivery System and converts the communications for
`transmission in the Sensor System format, and the relay
`device transmitter transmits the converted communications
`in the Sensor System format. Also, the Sensor System further
`includes a Sensor System receiver coupled to the Sensor
`System processor for receiving the communications from the
`relay device in the Sensor System format.
`0013. In still further embodiments, the fluid delivery
`System includes a display device contained in the delivery
`System housing and coupled to the delivery System proces
`Sor for displaying data to the user, and a user interface
`contained in the delivery System housing and coupled to the
`delivery System processor for accepting one or more inputs
`from the user. At least one of the inputs generates a request
`for the data indicative of the physiological characteristic
`level of the user from the Sensor System, at least one of the
`communications transmitted from the fluid delivery System
`through the relay device to the Sensor System includes the
`request, and at least one of the communications including
`the data indicative of the physiological characteristic level of
`the user is transmitted from the Sensor System through the
`relay device and received by the delivery System in response
`to the request. The display device then displays the data
`indicative of the physiological characteristic level of the user
`received by the fluid delivery system. Additionally, the user
`interface may be dedicated for interfacing from the fluid
`delivery System with the Sensor System through the relay
`device. Also, the requested data is the most recent data
`indicative of the physiological characteristic level of the user
`received by the fluid delivery system.
`0014.
`In yet other embodiments, the data indicative of the
`physiological characteristic level of the user received by the
`fluid delivery system is uncalibrated data. The fluid delivery
`System includes a calibration algorithm executed by the
`delivery System processor for calibrating the uncalibrated
`data to generate one or more measurements indicative of the
`physiological characteristic level of the user.
`0015. In alternative embodiments, the data indicative of
`the physiological characteristic level of the user received by
`the fluid delivery system includes one or more calibrated
`measurements indicative of the physiological characteristic
`
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`level of the user. In particular alternative embodiments, the
`Sensor System includes a calibration algorithm executed by
`the Sensor System processor for calibrating the Signal indica
`tive of the physiological characteristic level of the user to
`generate the one or more measurements indicative of the
`physiological characteristic level of the user, and the com
`munications transmitted from the Sensor System through the
`relay device and received by the fluid delivery system
`include the one or more measurements indicative of the
`physiological characteristic level of the user. In other par
`ticular alternative embodiments, the data indicative of the
`physiological characteristic level of the user received from
`the Sensor System by the relay device is uncalibrated data.
`The relay device includes a calibration algorithm executed
`by the relay device processor for calibrating the uncalibrated
`data to generate one or more measurements indicative of the
`physiological characteristic level of the user, and the com
`munications transmitted from the relay device and received
`by the fluid delivery system include the one or more mea
`Surements indicative of the physiological characteristic level
`of the user.
`0016. In additional alternative embodiments, at least one
`of the communications transmitted from the Sensor System
`through the relay device and received by the delivery System
`includes one or more commands for programming the
`amount of the fluid infused into the user based upon the data
`indicative of the physiological characteristic level of the
`user. In Some embodiments, the Sensor System includes a
`display device coupled to the Sensor System processor for
`displaying data to the user, and a user interface coupled to
`the Sensor System processor for accepting one or more inputs
`from the user. At least one of the inputs causes the display
`device to display the data indicative of the physiological
`characteristic level of the user obtained by the sensor
`System. Also, at least another one of the inputs generates the
`one or more commands for programming the amount of the
`fluid infused into the user based upon the data indicative of
`the physiological characteristic level of the user obtained by
`the Sensor System. In other embodiments, the Sensor System
`includes a closed loop algorithm executed by the Sensor
`System processor for automatically generating the one or
`more commands for programming the amount of the fluid to
`be infused into the user based upon the data indicative of the
`physiological characteristic level of the user obtained by the
`Sensor System.
`0.017. In further alternative embodiments, at least one of
`the communications transmitted from the Sensor System to
`the relay device includes the data indicative of the physi
`ological characteristic level of the user, and at least one of
`the communications transmitted from the relay device and
`received by the fluid delivery system includes one or more
`commands for programming the amount of the fluid infused
`into the user based upon the data indicative of the physi
`ological characteristic level of the user. In particular embodi
`ments, the relay device includes a display device coupled to
`the relay device processor for displaying data to the user, and
`a user interface coupled to the relay device processor for
`accepting one or more inputs from the user. At least one of
`the inputs causes the display device to display the data
`indicative of the physiological characteristic level of the user
`obtained by the Sensor System. Also, at least another one of
`the inputs generates the one or more commands for pro
`gramming the amount of the fluid infused into the user based
`upon the data indicative of the physiological characteristic
`
`level of the user obtained by the sensor system. In other
`particular embodiments, the relay device further includes a
`closed loop algorithm executed by the relay device proces
`Sor for automatically generating the one or more commands
`for programming the amount of the fluid to be infused into
`the user based upon the data indicative of the physiological
`characteristic level of the user obtained by the sensor
`System.
`0018. In yet additional embodiments, the sensor system
`format and the delivery system format utilize different
`frequencies for communications transmitted from the Sensor
`system through the relay device and received by the fluid
`delivery System. In Some embodiments, the Sensor System
`format and the delivery system format utilize different
`communication protocols for communications transmitted
`from the Sensor System through the relay device and
`received by the fluid delivery system. The communication
`protocols may utilize different carrier media and/or infor
`mation packaging for communications transmitted from the
`Sensor System through the relay device and received by the
`fluid delivery system.
`0019. In particular embodiments, the delivery system
`processor has a unique identification code, and the Sensor
`System processor has the capability to learn the unique
`identification code of the delivery System processor. Further,
`the communications transmitted from the Sensor System
`through the relay device and received by the fluid delivery
`System include the unique identification code of the delivery
`System processor to Substantially avoid interference with
`other devices. In other particular embodiments, the Sensor
`System processor has a unique identification code, and the
`delivery System processor has the capability to learn the
`unique identification code of the Sensor System processor.
`Further, the communications transmitted from the Sensor
`system through the relay device and received by the fluid
`delivery System include the unique identification code of the
`Sensor System processor to Substantially avoid interference
`with other devices. In still other particular embodiments, the
`relay device processor has a unique identification code, and
`the Sensor System processor has the capability to learn the
`unique identification code of the relay device processor.
`Also, the communications transmitted from the Sensor Sys
`tem to the relay device include the unique identification code
`of the relay device processor to Substantially avoid interfer
`ence with other devices. In yet other particular embodi
`ments, the relay device processor has a unique identification
`code, and the delivery System processor has the capability to
`learn the unique identification code of the relay device
`processor. Also, the communications transmitted from the
`relay device and received by the fluid delivery system
`include the unique identification code of the relay device
`processor to Substantially avoid interference with other
`devices.
`0020. In additional embodiments, the relay device is
`coupled to the delivery System housing. In other embodi
`ments, the relay device is contained in the delivery System
`housing. In Still other embodiments, the relay device is
`coupled to the Sensor System housing. In further embodi
`ments, the Sensor System is a glucose monitoring System,
`and the fluid delivery System is an insulin infusion device.
`0021. In another embodiment of the present invention, a
`relay device transferS information between a Sensor System
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`and a fluid delivery System. The Sensor System measures a
`physiological characteristic level of a user, and the fluid
`delivery system infuses a fluid into the user. The relay device
`includes a Sensor System receiver for receiving one or more
`communications from the Sensor System in a Sensor System
`format, a processor for processing the communications from
`the Sensor System and converting the communications for
`transmission in a delivery System format, and a delivery
`System transmitter for transmitting the converted commu
`nications in the delivery system format to the fluid delivery
`System.
`0022. In some embodiments, the relay device includes a
`delivery System receiver for receiving one or more commu
`nications from the fluid delivery system in the delivery
`System format. The processor further processes the commu
`nications from the fluid delivery system and converts the
`communications for transmission in the Sensor System for
`mat. The relay device also includes a Sensor System trans
`mitter for transmitting the converted communications in the
`Sensor System format to the Sensor System. In other embodi
`ments, at least one of the communications transmitted from
`the Sensor System through the relay device and received by
`the fluid delivery system include data indicative of the
`physiological characteristic level of the user. In yet other
`embodiments, at least one of the communications transmit
`ted from the Sensor System through the relay device and
`received by the fluid delivery system include one or more
`commands for programming an amount of the fluid to be
`infused into the user based upon data indicative of the
`physiological characteristic level of the user obtained by the
`Sensor System.
`0023. In further embodiments, at least one of the com
`munications transmitted from the Sensor System to the relay
`device include data indicative of the physiological charac
`teristic level of the user, and at least one of the communi
`cations transmitted from the relay device and received by the
`fluid delivery System include one or more commands for
`programming an amount of the fluid to be infused into the
`user based upon the data indicative of the physiological
`characteristic level of the user. Additionally, the relay device
`may include a display device coupled to the processor for
`displaying data to the user, and a user interface coupled to
`the processor for accepting one or more inputs from the user.
`At least one of the inputs causes the display device to display
`the data indicative of the physiological characteristic level of
`the user. Also, at least another one of the inputs generates the
`one or more commands for programming the amount of the
`fluid to be infused into the user based upon the data
`indicative of the physiological characteristic level of the
`USC.
`In still other embodiments, the sensor system for
`0024.
`mat and the delivery System format utilize different frequen
`cies for communications transmitted from the Sensor System
`through the relay device to the fluid delivery system. In yet
`other embodiments, the Sensor System format and the deliv
`ery System format utilize different communication protocols
`for communications transmitted from the Sensor System
`through the relay device to the fluid delivery system. The
`communication protocols may utilize different carrier media
`and/or information packaging for communications transmit
`ted from the Sensor System through the relay device to the
`fluid delivery system.
`
`0025. In yet another embodiment of the present inven
`tion, a relay device transferS information between a Sensor
`System and a fluid delivery System. The Sensor System
`measures a physiological characteristic level of a user, and
`the fluid delivery system infuses a fluid into the user. The
`relay device includes a Sensor System transceiver for trans
`mitting and receiving one or more communications to and
`from the Sensor System. The communications are transmit
`ted and received in a Sensor System format. The relay device
`also includes a delivery System transceiver for transmitting
`and receiving one or more communications to and from the
`fluid delivery System. The communications are transmitted
`and received in a delivery System format. The relay device
`further includes a processor for processing the communica
`tions from the Sensor System and the fluid delivery System.
`The processor converts the communications received from
`the Sensor System in the Sensor System format for transmis
`sion in the delivery system format to the fluid delivery
`System, and further converts the communications received
`from the fluid delivery system in the delivery system format
`for transmission in the Sensor System format to the Sensor
`System.
`0026. In particular embodiments, at least one of the
`communications transmitted from the Sensor System through
`the relay device and received by the fluid delivery system
`include data indicative of the physiological characteristic
`level of the user. In other particular embodiments, at least
`one of the communications transmitted from the Sensor
`system through the relay device and received by the fluid
`delivery System include one or more commands for pro
`gramming an amount of the fluid to be infused into the user
`based upon data indicative of the physiological characteris
`tic level of the user obtained by the sensor system.
`0027. In additional embodiments, at least one of the
`communications transmitted from the Sensor System to the
`relay device include data indicative of the physiological
`characteristic level of the user, and at least one of the
`communications transmitted from the relay device and
`received by the fluid delivery system include one or more
`commands for programming an amount of the fluid to be
`infused into the user based upon the data indicative of the
`physiological characteristic level of the user. Also, the relay
`device may include a display device coupled to the proces
`Sor for displaying data to the user, and a user interface
`coupled to the processor for accepting one or more inputs
`from the user. At least one of the inputs causes the display
`device to display the data indicative of the physiological
`characteristic level of the user. Additionally, at least another
`one of the inputs generates the one or more commands for
`programming