1
`•
`11,, ' '
`,,.]',._, 11 <l,,·'-1)1.:-·1;
`
`APPLICATION FOR
`UNITED STATES PATENT
`IN THE NAME OF
`
`V ARAZ SHAHMIRIAN,
`WAYNE A. MORGAN,
`SHELDON B. MOBERG,
`CARY D. TALBOT,
`ARTHUR A. CAMPBELL,
`AND
`JAY A. YONEMOTO
`
`ASSIGNED TO
`
`MEDTRONIC MINIMED, INC.
`
`FOR
`
`RELAY DEVICE FOR TRANSFERRING INFORMATION
`BETWEEN A SENSOR SYSTEM AND A FLUID DELIVERY SYSTEM
`
`DOCKET NO. PF01003 US
`
`Vivian S. Shin, Reg. No. 43,919
`Medtronic MiniMed, Inc.
`18000 Devonshire Street
`Northridge, CA 91325
`(818) 576-5291 (telephone)
`(818) 576-6202 (facsimile)
`
`Express Mail No. EL 837696802 US
`
`Page 1 of 88
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`TITLE
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`Relay Device for Transferring Information Between a Sensor System and a Fluid Delivery
`
`PATENT
`PF01003 US
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`System
`
`5 RELATED APPLICATIONS
`
`This application claims priority on U.S. Provisional Patent Application filed December
`
`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.
`
`10 BACKGROUND OF THE INVENTION
`
`Ambulatory pumps and hospital-based fluid delivery systems are used to deliver fluids
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`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
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`used to collect sensor data from a sensor, calibrate the sensor data to generate sensor
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`15 measurements, and display the sensor measurements. Next, the patient or a caregiver manually
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`calculates the required fluid dosage based on the displayed sensor measurements. Finally, the
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`patient or caregiver programs the pump or fluid delivery system to adjust the fluid dosage.
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`For example, patients with Type 1 diabetes and some patients with Type 2 diabetes use
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`insulin to control their blood glucose (BG) level. Typically, if a patient's BG level is too high,
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`20
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`the patient can inject a "bolus" (dose) of insulin to lower his/her BG level from its present level
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`to a desired target level. Furthermore, the patient may inject a bolus of insulin in anticipation of
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`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
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`25
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`system, or an automated intermittent blood glucose measurement system. When the BG
`
`monitoring 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
`
`m~asurement to manually calculate a required insulin bolus (i.e., the amount of insulin to inject).
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`Finally, once the required insulin bolus is calculated, the patient or caregiver must utilize an
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`insulin delivery device (e.g., infusio~ pump, injection pen, IV meter, or the like) to deliver the
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`insulin bolus into the patient's body.
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`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
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`5
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`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. Additionally, if the BG monitoring
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`system and the insulin delivery device are not developed in conjunction with one another, they
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`typically communicate using different frequencies and/or modes of communication, and as a
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`result, cannot communicate directly with one another. Thus, the patient or caregiver must
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`10 manually calculate the required insulin bolus and program the insulin delivery device
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`accordingly, \.\'.hich requires effort by the patient or caregiver and is subject to calculation errors.
`I
`Alternatively, the patient or caregiver must manually enter the BG measurement into an
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`electronic computing device with bolus estimation software for calculating the required insulin
`
`bolus ( e.g., a computer, the Internet, a personal digital assistant (PDA), or an insulin delivery
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`15
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`device, such as an infusion pump, injection pen, N meter, or the like), which also requires effort
`
`by the patient or caregiver and is subject to transcription errors. For example, the patient or
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`caregiver may not accurately enter the BG measurement that is displayed on the BG
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`measurement device into the electronic computing device, and thus, the resulting bolus estimate
`
`calculation may not be accurate.
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`20
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`SUMMARY OF THE INVENTION
`
`It is an object of an embodiment of the present invention to provide an improved infusion
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`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.
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`25
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`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 physiological
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`30
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`characteristic level of the user, and a sensor system transmitter contained in the sensor system
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`housing and coupled to the sensor system processor for transmitting one or more
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`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
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`5
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`communications for transmission in a delivery system format, and a relay device transmitter for
`
`transmitting the converted communications in the delivery system format. The fluid delivery
`
`system includes a delivery system housing, 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
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`10
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`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
`
`_ physiological characteristic level of the user.
`
`In particular embodiments, at least one of the communications transmitted from the
`
`15
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`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
`
`including 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
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`20
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`contained in the delivery system housing and coupled to the delivery system processor for
`
`automatically displaying to the user the data indicative 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 data
`
`to the user, and a user interface contained in the housing and coupled to the delivery system
`
`25
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`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.
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`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
`
`5
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`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.
`
`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
`
`10
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`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.
`
`15
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`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
`
`20
`
`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.
`
`In still other embodiments, t~e fluid delivery system includes a user interface for
`
`accepting one or more inputs from the user, and the user interface is contained in the delivery
`
`25
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`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
`
`embodiments, 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
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`30
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`upon the data indicative of the physiological characteristic level of the user received by the fluid
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`PATENT
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`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
`
`5
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`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
`
`10
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`physiological characteristic level of the user received by the fluid delivery system is above or
`
`below a target characteristic value.
`
`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 communications in the delivery system format. The relay
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`15
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`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
`
`20
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`system processor for receiving the communications from the relay device in the sensor system
`
`format.
`
`In still further 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
`
`25
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`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
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`30
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`of the user is transmitted from the sensor system through the relay device and received by the
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`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
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`5
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`indicative of the physiological characteristic level of the user received by the fluid delivery
`
`system.
`
`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
`
`IO
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`uncalibrated data to generate one or more measurements indicative of the physiological
`
`characteristic level of the user.
`
`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 level of the user. In particular alternative
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`15
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`embodiments, the sensor system includes a calibration algorithm executed by the sensor system
`
`processor for calibrating the signal indicative 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 communications 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
`
`20
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`physiological characteristic level of the user. In other particular 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
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`25
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`communications transmitted from 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 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
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`30
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`or more commands for programming the amount of the fluid infused into the user based upon the
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`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
`
`5
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`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
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`10
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`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.
`
`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 physiological
`
`15
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`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
`
`physiological characteristic level of the user. In particular embodiments, the relay device
`
`includes a display device coupled to the relay device processor for displaying data to the user,
`
`20
`
`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 programming the amount of the fluid
`
`infused into the user based upon the data indicative of the physiological characteristic level of the
`
`25
`
`user obtained by the sensor system. In other particular embodiments, the relay device further
`
`includes a closed loop algorithm executed by the relay device 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.
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`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
`
`5
`
`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
`
`information packaging for communications tr~nsmitted from the sensor system through the relay
`
`device and received by the fluid delivery system.
`
`In particular embodiments, the delivery system processor has a unique identification code,
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`10
`
`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
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`15
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`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
`
`20
`
`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 system to the relay device include the unique identification code of the relay device
`
`processor to substantially avoid interference with other devices. In yet other particular
`
`embodiments, the relay device processor has a unique identification code, and the delivery
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`25
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`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.
`
`In additional embodiments, the relay device is coupled to the delivery system housing. In
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`30
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`other embodiments, the relay device is contained in the delivery system housing. In still other
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`embodiments, the relay device is coupled to the sensor system housing. In further embodiments,
`
`the sensor system is a glucose monitoring system, and the fluid delivery system is an insulin
`
`infusion device.
`
`In another embodiment of the present invention, a relay device transfers information
`
`5
`
`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 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
`
`10
`
`a delivery system format, and a delivery system transmitter for transmitting the converted
`
`communications in the delivery system format to the fluid delivery system.
`
`In some embodiments, the relay device includes a delivery system receiver for receiving
`
`one or more communications from the fluid delivery system in the delivery system format. The
`
`processor further processes the communications from the fluid delivery system and converts the
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`15
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`communications for transmission in the sensor system format. The relay device also includes a
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`sensor system transmitter for transmitting the converted communications in the sensor system
`
`format to the sensor system. In other 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 yet other
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`20
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`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
`
`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.
`
`In further embodiments, at least one of the communications transmitted from the sensor
`
`25
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`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. Additionally, the relay device may include a display device coupled to the processor
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`30
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`for displaying data to the user, and a user interface coupled to the processor for accepting one or
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`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
`
`5
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`user.
`
`In still other embodiments, the sensor system format and the delivery system format
`
`utilize different frequencies 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 delivery system format utilize different communication protocols for communications
`
`10
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`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 transmitted from the sensor system through the relay device to the fluid delivery
`
`system.
`
`In yet another embodiment of the present invention, a relay device transfers information
`
`15
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`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 transmitting and receiving one or
`
`more communications to and from the sensor system. The communications are transmitted and
`
`received in a sensor system format. The relay device also includes a delivery system transceiver
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`20
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`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 communications 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 transmission in the delivery system format to the
`
`25
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`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.
`
`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
`
`30
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`indicative of the physiological characteristic level of the user. In other particular embodiments,
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`at least one of the communications transmitted from the sensor system through the relay device
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`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.
`
`5
`
`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
`
`10
`
`characteristic level of the user. Also, 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. Additionally, at
`
`least another one of the inputs generates the one or more commands for programming the amount
`
`15
`
`of the fluid to be infused into the user based upon the data indicative of the physiological
`
`characteristic level of the user.
`
`In further embodiments, the sensor system format and the delivery system format utilize
`
`different frequencies for communications transmitted between the sensor system and the fluid
`
`delivery system through the relay device. In additional embodiments, the sensor system format
`
`20
`
`and the delivery system format utilize different communication protocols for communications
`
`transmitted between the sensor system and the fluid delivery system through the relay device.
`
`The communication protocols may utilize different carrier media and/or information packaging
`
`for communications transmitted between the sensor system and the fluid delivery system through
`
`the relay device.
`
`25
`
`In still another embodiment of the present invention, an infusion system for infusing a
`
`fluid into a user includes a sensor system and a fluid delivery system. The sensor system
`
`includes a sensor for producing a signal indicative of a physiological characteristic level of the
`
`user, a sensor system processor coupled to the sensor for processing the signal indicative of the
`
`physiological characteristic level of the user, and a sensor system transmitter coupled to the
`
`30
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`sensor system processor for transmitting one or more communications in a sensor system format.
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`•• il
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`cl"!h
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`,.JI,_ if~!
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`PATENT
`PF01003 US
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`The fluid delivery system includes a delivery system housing, a relay device contained in the
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`delivery system housing, a delivery system receiver, and a delivery system processor. The relay
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`device includes a relay device receiver for receiving the communications from the sensor system
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`in the sensor system format, a relay device processor for processing the communications from the
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`5
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`sensor system and converting the communications for transmission in a delivery system format,
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`and a relay device transmitter for transmitting the converted communications in the delivery
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`system format. The delivery system receiver is contained in the delivery system housing and
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`receives the communications from the relay device in the delivery system format. The delivery
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`system processor is also contained in the delivery system housing and is coupled to the delivery
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`system receiver, and processes the communications from the relay device in the delivery system
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`format and controls an amount of the fluid infused into the user. The amount of the fluid infused
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`into the user is determined based upon data indicative of the physiological characteristic level of
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`the user obtained by the sensor system.
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`In particular embodiments, at least one of the communications transmitted from the
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`sensor system through the relay device and received by the fluid delivery system include data
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`indicative of the physiological characteristic level of the user. Additionally, the communications
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`including the data indicative of the physiological characteristic level of the user may be
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`automatically transmitted from the sensor system through the relay device and received by the
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`fluid delivery system. Further, the fluid delivery system may also include a display device
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`contained in the delivery system housing and coupled to the delivery system processor for
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`automatically displaying to the user the data indicativ