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`US 20070093786Al
`
`c19) United States
`c12) Patent Application Publication
`Goldsmith et al.
`
`c10) Pub. No.: US 2007/0093786 Al
`Apr. 26, 2007
`(43) Pub. Date:
`
`(54) WATCH CONTROLLER FOR A MEDICAL
`DEVICE
`
`Continuation-in-part of application No. 11/204,667,
`filed on Aug. 16, 2005.
`
`(75)
`
`Inventors: Joel Goldsmith, Studio City, CA (US);
`Andrew C. Hayes, Simi Valley, CA
`(US)
`
`Correspondence Address:
`PILLSBURY WINTHROP SHAW PITTMAN
`LLP
`P.O BOX 10500
`McLean, VA 22102 (US)
`
`Publication Classification
`
`(51)
`
`Int. Cl.
`A61K 9122
`A61M 37100
`
`(2006.01)
`(2006.01)
`
`(52) U.S. Cl. ......................................... 604/890.1; 604/131
`
`(73) Assignee: MEDTRONIC MINIMED,
`Northridge, CA (US)
`
`INC.,
`
`(57)
`
`ABSTRACT
`
`(21) Appl. No.:
`
`11/496,606
`
`(22) Filed:
`
`Jul. 31, 2006
`
`Related U.S. Application Data
`
`(63) Continuation-in-part of application No. 11/204,583,
`filed on Aug. 16, 2005.
`
`An infusion system that includes a watch controller device
`and a communication system to transmit the communica(cid:173)
`tions from the watch controller device to an infusion device
`pump that controls delivery of fluids to the user's body.
`More particularly, these apparatuses and methods are for
`providing convenient monitoring and control of the infusion
`pump device in determining the appropriate amount of
`insulin to deliver.
`
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`45b
`
`Page 1 of 26
`
`

`

`Patent Application Publication Apr. 26, 2007 Sheet 1 of 10
`
`US 2007/0093786 Al
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`Page 2 of 26
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`

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`Patent Application Publication Apr. 26, 2007 Sheet 2 of 10
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`US 2007/0093786 Al
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`Page 3 of 26
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`Patent Application Publication Apr. 26, 2007 Sheet 3 of 10
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`Page 5 of 26
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`

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`Patent Application Publication Apr. 26, 2007 Sheet 5 of 10
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`US 2007/0093786 Al
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`Page 6 of 26
`
`

`

`Patent Application Publication Apr. 26, 2007 Sheet 6 of 10
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`US 2007/0093786 Al
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`FIG. 7
`
`Page 7 of 26
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`

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`Patent Application Publication Apr. 26, 2007 Sheet 7 of 10
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`Patent Application Publication Apr. 26, 2007 Sheet 8 of 10
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`Page 9 of 26
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`Patent Application Publication Apr. 26, 2007 Sheet 9 of 10
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`Page 10 of 26
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`Patent Application Publication Apr. 26, 2007 Sheet 10 of 10
`
`US 2007/0093786 Al
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`·----------------------------------------------------------
`
`Page 11 of 26
`
`

`

`US 2007/0093786 Al
`
`Apr. 26, 2007
`
`1
`
`WATCH CONTROLLER FOR A MEDICAL DEVICE
`
`RELATED APPLICATIONS
`
`[0001] This patent application is a continuation-in-part of
`U.S. patent application Ser. No. 11/204,583, filed on Aug.
`16, 2005 and a continuation-in-part of U.S. application Ser.
`No. 11/204,667, filed on Aug. 16, 2005, which are herein
`incorporated by reference.
`
`FIELD OF THE INVENTION
`
`[0002] Embodiments of this invention relate generally to
`infusion systems and methods for delivering fluids into an
`individual's body and monitoring systems and methods for
`monitoring analyte levels in an individual's body. More
`particularly, embodiments of this invention relate to appa(cid:173)
`ratuses and methods for providing a convenient way in
`which to monitor and control the fluids delivered to the
`individual's body and to monitor the analyte levels in the
`individual's body.
`
`DESCRIPTION OF THE RELATED ART
`
`[0003] Patients with Type 1 diabetes and some patients
`with Type 2 diabetes use insulin to control their blood
`glucose (BG) level. Diabetics must modify their daily lif(cid:173)
`estyle to keep their body in balance. To do so, diabetics need
`to keep strict schedules, including ingesting timely nutri(cid:173)
`tious meals, partaking in exercise, monitoring BG levels
`daily, and-adjusting and administering insulin dosages
`accordingly. Testing of BG levels has been both painful and
`awkward for the patient. Traditionally, insulin dependent
`diabetics were required to monitor their BG levels by
`puncturing a finger tip with a needle. Due to the fact that
`many patients must conduct such a test multiple times
`throughout the day to regulate their BG levels, the procedure
`can be painful and inconvenient.
`
`[0004] Typically, patients may employ various calcula(cid:173)
`tions to determine the amount of insulin to inject. For
`example, bolus estimation software is available for calcu(cid:173)
`lating an insulin bolus. Patients may use these software
`programs on an electronic computing device, such as a
`computer, the Internet, a personal digital assistant (PDA), or
`an insulin delivery device. Insulin delivery devices include
`infusion pumps, injection pens, and implantable delivery
`systems. The better bolus estimation software takes into
`account the patient's present BG level. Presently, a patient
`must measure his/her blood glucose using a BG measure(cid:173)
`ment device, such as a test strip meter, a continuous glucose
`measurement system, or a hospital hemacue. BG measure(cid:173)
`ment devices use various methods to measure the BG level
`of a patient, such as a sample of the patient's blood, a sensor
`in contact with a bodily fluid, an optical sensor, an enzy(cid:173)
`matic sensor, or a fluorescent sensor. When the BG mea(cid:173)
`surement device has generated a BG measurement, the
`measurement is displayed on the BG measurement device.
`Then the patient may visually read the BG measurement and
`physically enter the BG measurement into an electronic
`computing device to calculate a bolus estimate. Finally, once
`the bolus estimate is calculated, the patient must inject the
`insulin bolus or program an insulin delivery device to
`deliver the bolus into their body. Unfortunately, this process
`is also cumbersome and is subject to transcribing errors-for
`example, the patient may inaccurately enter the BG mea-
`
`surement that is displayed on the BG measurement device
`into the electronic computing device. Thus, if the BG
`measurement is not entered correctly, the bolus estimate is
`not accurate, which may lead to the delivery of an inappro(cid:173)
`priate insulin dose. In other devices, the measurement is
`transmitted to the electronic computing device.
`
`[0005]
`In infusion systems where a display is included for
`convenient viewing of selected information, such as that
`requested by the user or an instructed act that was under(cid:173)
`taken by an infusion device or a sensing device, the display
`is generally located on the device. This may be inconvenient
`for the user to view information because infusion devices
`and sensors are typically secured to or near a site on the
`user's body. Thus, viewing may require the user to move or
`manipulate the infusion device or sensor to view the display
`which may lead to improper reading of the display.
`
`BRIEF SUMMARY OF THE INVENTION
`
`[0006]
`In accordance with embodiments of the invention,
`an infusion system is provided that allows for the control of
`the delivery of a fluid or medication. An embodiment of the
`present invention includes a controller device and a therapy/
`diagnostic device, such as an infusion device. The controller
`device may be a hand-held device, separate from the infu(cid:173)
`sion device, that allows the user to communicate with the
`infusion device without actually handling the infusion
`device.
`
`[0007] The controller device includes a housing adapted to
`be carried by the user and a communication system con(cid:173)
`tained in the housing for transmitting a communication or
`command from the user to the infusion device. In alternative
`embodiments, the controller device may receive communi(cid:173)
`cations sent from the infusion device or other components of
`the infusion system, such as for example, a characteristic
`determining device. Further, the controller device may
`include a user input device on the controller device housing,
`such as keys, buttons, or the like, for the user to input data
`or commands.
`
`[0008] The controller device includes on the housing a
`display that may mimic the display on the infusion device.
`In certain embodiments, whatever is shown on the infusion
`device corresponds to that shown and reflected on the
`display of the controller device. The controller device dis(cid:173)
`play shows information according to communications sent
`to it from the infusion device. The user may more conve(cid:173)
`niently view what is being processed or acted upon in the
`infusion device without removing or adjusting the infusion
`device to view the display. In further embodiments, the
`controller device may be configured so that the input devices
`included allow all, or substantially all, viewing and data
`entry to be performed on the controller device without
`moving or referring to the infusion device.
`
`[0009]
`In further embodiments, the controller device may
`control an analyte sensing device such as a continuous
`glucose sensor. The controller device display shows infor(cid:173)
`mation according to communications sent to it from the
`sensing device. In further embodiments, the controller
`device may control more than one device, for example, an
`infusion pump and an analyte sensor.
`
`[0010]
`In further embodiments, the controller device may
`include time-telling functions. For example, the controller
`
`Page 12 of 26
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`

`

`US 2007/0093786 Al
`
`Apr. 26, 2007
`
`2
`
`device may be a wrist-worn device, such as a watch. The
`controller device may also be a watch that can be carried on
`other parts of the body or clothing, such as the ankle, neck
`(e.g., on a chain), pocket, or ankle.
`
`[0011] Among other advantages, embodiments of the
`present invention may provide convenience and ease of use.
`For example, an embodiment with a user interface and
`display on the controller device may cater to the active
`lifestyles of many insulin dependent diabetics. A large and
`simple display minimizes the potential for error in reading
`and interpreting test data. A small overall size permits
`discretion during self-monitoring and makes it easy to carry.
`In another embodiment, the controller device may be inte(cid:173)
`grated with a characteristic determining device into one
`housing and feature a large target area for strip insertion to
`make the monitoring procedure fast and accurate. In some
`embodiments, the controller device display may include a
`dedicated backlight to facilitate viewing.
`
`[0012] The controller device also reflects the other func(cid:173)
`tions that the particular infusion device may show, including
`a variety of other displays, for example, when the last bolus
`was administered, when the last alarm occurred, when the
`last finger stick was taken, past trends, all alarms that
`occurred in a time period, calibrations, meals, exercise,
`bolus schedules, temporary basal delivery, diagnostic infor(cid:173)
`mation, and the like. Whenever a bolus is being delivered,
`the infusion device can send a message every time a tenth of
`a unit, or some specified amount, is delivered, to which the
`user may monitor via the controller device display.
`
`[0013]
`In certain embodiments, the infusion device is the
`central hub with peripheral devices being the controller
`device and a characteristic determining device. The charac(cid:173)
`teristic determining device being adapted to sense and
`determine the concentration of an analyte of a patient and
`directs the infusion device fluid delivery according to the
`measurements. While the term "analyte" is used herein, it is
`possible to determine and use other characteristics as well
`using the same type of system. The control is maintained in
`the central hub and the infusion device sends out most of the
`commands. The infusion device also sends requests to
`receive specific data from the controller device and the
`characteristic determining device, if one is included.
`
`[0014]
`In particular embodiments, where the controller
`device is integrated with the characteristic determining
`device into one housing, the controller device may auto(cid:173)
`matically transmit communications including the data
`indicative of the determined concentration of the analyte in
`the user to the infusion device. In other particular embodi(cid:173)
`ments, the controller device further includes a user input
`device for inputting commands, and transmits the commu(cid:173)
`nications to the infusion device in response to a command
`from the user input device. In additional embodiments, the
`controller device further includes an indicator to indicate a
`status of the communication including the data indicative of
`the determined concentration of the analyte in the user being
`transmitted from the determining device communication
`system to the infusion device communication system. Data
`compression may be employed to speed up communications.
`
`[0015]
`In further embodiments, the infusion device may
`contain all or substantially all of the intelligence. The
`amount of time that the controller communicates with the
`infusion device or other components may be limited to save
`
`power in the controller device. For example, radio-fre(cid:173)
`quency (RF) communications may be minimized, such that
`the marriage between the infusion device and controller
`occurs once until further communication is necessary to
`exchange data. The information regarding the screens dis(cid:173)
`played is sent to the controller, and when the infusion device
`needs to display a screen, it sends a screen number to the
`controller. In the case of screen displays, if the data being
`sent is fixed, then the screen can be simply displayed. If the
`data is variable, then the variable data is sent with the screen
`to the infusion device. Exchange IDs, strings to be dis(cid:173)
`played, and foreign languages are among data that may be
`sent from the controller. Further commands that may be sent
`from the infusion device include, among other commands, a
`command to show a specific screen on the controller device,
`a command for displaying requested information on the
`screen, a command for showing the rules for the input
`devices, a command for showing the intelligence about that
`screen type (e.g., menus, data entries, etc.), and the like.
`[0016] The controller device and the infusion device may
`communicate to one another through wireless or non-wire(cid:173)
`less methods. Some examples of wireless methods include,
`by no way in limitation, RF, infrared (IR), Bluetooth,
`ZigBee, and other 802.15 protocols, 802.11 WiFi, spread
`spectrum communication, and frequency hopping commu(cid:173)
`nication. Further examples include giving the controller
`device cellular telephone or pager capabilities. In the alter(cid:173)
`native, the communication may be wired, such as in hospital
`use. In a wired embodiment, there may be a tether physically
`connecting the infusion device to the controller device. In
`yet another alternative, the controlling device and the infu(cid:173)
`sion device could be both wired and wireless-when wired,
`the two components communicate by wire, and when dis(cid:173)
`connected, the two components could operate through wire(cid:173)
`less communication.
`
`[0017]
`In another wireless example, if the user has access
`to a computer network or phone connection, the user can
`open communication via the internet to obtain communica(cid:173)
`tions from, and send communications to, a nurse, parent, or
`anyone so desired. A transceiver may be used to facilitate
`data transfer between the PC and the infusion device. Such
`a communication may also be used by a party, other than the
`user, to control, suspend, and/or clear alarms. This embodi(cid:173)
`ment could be very useful for a parent to monitor the
`infusion system of a child, or for a physician to monitor the
`infusion system of a patient. As a non-limiting example,
`further description of a communication station may be found
`in U.S. Pat. No. 5,376,070, which is herein incorporated by
`reference. The transceiver may allow patients at home or
`clinicians in a hospital setting to communicate with the
`various components of the infusion system via RF telemetry.
`The transceiver may be used to download device informa(cid:173)
`tion from the infusion device and sent to the PC when the
`transceiver is connected in to the serial port of the PC. In
`embodiments, the transceiver may derive its power from the
`PC when the two are connected. In this way, the transceiver
`conveniently does not require a separate power source. In
`another embodiment, a cellular phone may be used as a
`conduit for remote monitoring and programming. In yet
`other embodiments, the controller device may also act as a
`transceiver, which would eliminate an extra component.
`
`[0018]
`In yet further embodiments, the infusion system
`includes an infusion device and/or a sensing device. The
`
`Page 13 of 26
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`

`

`US 2007/0093786 Al
`
`Apr. 26, 2007
`
`3
`
`sensing device includes a sensor and a transmitter in com(cid:173)
`munication with the infusion device. The transmission may
`occur via wire or wireless methods. The sensing device
`includes a sensor and a transmitter in communication with
`the infusion device. The sensing device may sense an
`analyte of a bodily fluid of the user and provide continuous
`monitoring of that analyte. The sensing device may be
`calibrated using data from the infusion device and/or from a
`characteristic determining device. In further embodiments,
`the sensing device senses additional physiological charac(cid:173)
`teristics. In still further embodiments, the system is set up to
`automatically call for assistance when analytes reach a
`certain level. The system may be set up to notify others, for
`example, through a cellular network. In such a manner, the
`patient's cellular telephone may be used to connect to
`emergency services. The call may include a global position(cid:173)
`ing system (GPS) location. GPS functions may be included
`separately from cellular telephone type functions.
`
`[0019] Communications between the system components
`may be performed in a variety of manners. In an embodi(cid:173)
`ment using RF options, there could be employed a "spread
`spectrum" where a large range of RFs can be used to relay
`the communication. In another embodiment, changing fre(cid:173)
`quencies can be used so as to pick up whatever frequency is
`present. This is known as frequency hopping, where the
`frequency changes periodically or so to take advantage of
`all, or substantially all, frequencies available. Another
`embodiment is one that uses adaptive frequency selection, or
`Listen Before Talk (LBT), where the devices select the
`cleanest available channel from those allotted prior to trans(cid:173)
`mitting. In some cases, frequency hopping allows the system
`to find frequencies that are not being used by other nearby
`systems and thus avoid interference. In addition, a system
`may operate in a manner where each component-to-compo(cid:173)
`nent communication is on a different frequency, or where the
`delay for each communication is different. Other types of
`RF, that are not described, may also be used for communi(cid:173)
`cation, such as, translation frequency.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`[0020] 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 figures.
`
`[0021] FIG. 1 is a front view of a controller device
`according to an embodiment of the invention.
`
`[0022] FIG. 2 is a front view of a blood glucose meter
`integrated into a controller device housing according to an
`embodiment of the invention.
`[0023] FIG. 3 is a front view of a blood glucose meter
`integrated into a controller device housing according to
`another embodiment of the invention.
`
`[0024] FIG. 4 is a front view of a blood glucose meter
`integrated into a controller device housing communicating
`with an infusion device according to an embodiment of the
`invention.
`
`[0025] FIG. 5 is a block diagram of an RF communication
`system in the infusion device according to an embodiment of
`the invention.
`[0026] FIG. 6A is a block diagram of a controller device
`according to an embodiment of the invention.
`
`[0027] FIG. 6B is a block diagram of a controller device
`according to an embodiment of the invention.
`
`[0028] FIG. 7 is a block diagram of different communi(cid:173)
`cation paths within the infusion system according to an
`embodiment of the invention.
`[0029] FIG. 8 is a diagram of the electronics architecture
`of a controller device according to an embodiment of the
`invention with a custom integrated circuit.
`
`[0030] FIG. 9A is a front view of a combined watch and
`controller device according to an embodiment of the inven(cid:173)
`tion.
`[0031] FIG. 9B is a rear view of a combined watch and
`controller device according to an embodiment of the inven(cid:173)
`tion.
`[0032] FIG. 10 is a block diagram of a combined watch
`and controller device according to an embodiment of the
`invention.
`
`DETAILED DESCRIPTION OF THE
`INVENTION
`[0033]
`In the following description, reference is made to
`the accompanying drawings which form a part hereof and
`which illustrate several embodiments of the present inven(cid:173)
`tions. It is understood that other embodiments may be
`utilized and structural and operational changes may be made
`without departing from the scope of the present inventions.
`[0034]
`In one embodiment, the controller device is a
`hand-held device separate from the therapy/diagnostic
`device, such as an infusion device, that allows the user to
`communicate with the therapy/diagnostic device without
`actually handling the device. Other examples of therapy/
`diagnostic devices include electronic therapy devices and
`devices that receive diagnostic information from cardiac and
`other sensors. As illustrated in FIG. 1, the controller device
`5 includes a housing 3 adapted to be carried by the user and
`a communication system (not shown) contained in the
`housing 3 for transmitting a communication or command
`from the user to the infusion device. In further embodiments,
`the controller device 5 may receive communications sent
`from the infusion device or other components of the infusion
`system, such as for example, a characteristic determining
`device. Further, the controller device may include one or
`more user input devices 2a and 2b on the controller device
`housing 3, such as keys, buttons, or the like, for the user to
`input data or commands. The controller device 5 includes a
`display 4 on the controller device housing 3 which simul(cid:173)
`taneously displays whatever information and/or graph is
`being displayed on the infusion device display at that
`moment. The display 4 allows a user to easily monitor and
`control what actions are taking place in, or being performed
`by, the infusion device. In some embodiments, the controller
`device 5 may further include a backlight 1 in the controller
`device display 4 for easier viewing. The backlight may be
`adapted to be in one or more colors, which can be user
`selectable for personalized use. In further embodiments, the
`backlight may be adapted to flash and/or tum to a color such
`as yellow or red when various alerts and alarms take place.
`In additional embodiments, the controller device 5 may
`include accessories such as hand straps 6 to provide conve(cid:173)
`nient handling. In particular embodiments, the controller is
`sized smaller than 6 inches long by 4 inches wide by 1 inch
`thick.
`
`Page 14 of 26
`
`

`

`US 2007/0093786 Al
`
`Apr. 26, 2007
`
`4
`
`[0035]
`In certain embodiments, a characteristic determin(cid:173)
`ing device that senses and determines the concentration of
`an analyte of a patient, for example blood glucose ("BG"),
`and controls the infusion device according to the measure(cid:173)
`ments, may be included in an infusion system with the
`controller device and the infusion device. The characteristic
`determining device includes a housing, a receptacle coupled
`to the housing for receiving and testing an analyte from the
`user to determine a concentration of the analyte in the user,
`a processor contained in the housing and coupled to the
`receptacle for processing the determined concentration of
`the analyte from the receptacle, and a communication sys(cid:173)
`tem contained in the housing and coupled to the processor
`for transmitting a communication including data indicative
`of the determined concentration of the analyte in the user. In
`particular embodiments,
`the characteristic determining
`device may also include a lancing device coupled to the
`receptacle for obtaining the analyte from the user.
`
`[0036]
`In embodiments, the infusion device includes a
`housing adapted to be carried by the user, a drive mechanism
`contained in the housing and operatively coupled with a
`reservoir containing the fluid for infusing the fluid into the
`body of the user, a communication system contained in the
`housing for receiving the communication including the data
`indicative of the determined concentration of an analyte in
`the user from a characteristic determining device, and a
`processor contained in the housing and coupled to the
`communication system for processing the data indicative of
`the determined concentration of the analyte in the user and
`controlling the infusion device. In particular embodiments,
`the infusion device is sized smaller than 6 inches long by 4
`inches wide by 1 inch thick.
`
`[0037] The infusion device may further include a bolus
`estimator used in conjunction with the processor for calcu(cid:173)
`lating an estimated amount of fluid to be infused into the
`body of the user based upon the received data indicative of
`the determined concentration of the analyte in the user and
`a target concentration of the analyte in the user, and an
`indicator to indicate when the estimated amount of fluid to
`be infused has been calculated. The system may determine
`the concentration of one of any variety of analyte types
`including, but not limited to, oxygen, blood, temperature,
`lactase, pH, implantable, and the like. Additionally, the
`infusion device may include a user input device, such as
`keys, buttons, or the like, for inputting an estimate of a
`material to be ingested by the user, and the bolus estimator
`may include the capability to calculate the estimated amount
`of fluid to be infused into the body of the user based upon
`the inputted estimate of the material to be ingested by the
`user. The infusion device may also include a memory for
`storing the data indicative of the determined concentration
`of the analyte in the user received by the infusion device
`communication system from the determining device com(cid:173)
`munication system.
`
`[0038]
`In still further alternative embodiments, the char(cid:173)
`acteristic determining device is a BG measurement device
`and may use samples from body fluids other than blood,
`such as interstitial fluid, spinal fluid, saliva, urine, tears,
`sweat, or the like. In yet other alternative embodiments,
`other measurement devices may be utilized to determine the
`concentrations, levels, or quantities of other characteristics,
`analytes, or agents in the user, such as hormones, choles(cid:173)
`terol, oxygen, pH, lactate, heart rate, respiratory rate, medi-
`
`cation concentrations, viral loads (e.g., HIV), or the like. In
`still other alternative embodiments, other fluids may be
`delivered to the user, such as medication other than insulin
`( e.g., HIV drugs, drugs to treat pulmonary hypertension, iron
`chelation drugs, pain medications, and anti-cancer treat(cid:173)
`ments), chemicals, enzymes, antigens, hormones, vitamins,
`or the like. Particular embodiments are directed towards the
`use in humans; however, in alternative embodiments, the
`infusion devices may be used in animals. For pain manage(cid:173)
`ment, a bolus function may be set up as a Patient Controlled
`Analgesic (PCA) function for customized delivery or the
`user may press a preset bolus button several times.
`[0039]
`In other embodiments, the characteristic determin(cid:173)
`ing device is a BG meter that determines BG level and the
`infusion device is an insulin infusion pump. The BG meter
`communicates the measurement of BG to the infusion pump
`device to determine the amount of insulin for delivery to the
`user. In alternative embodiments, the BG measurement
`device may be a continuous glucose measurement system, a
`hospital hemacue, an automated intermittent blood glucose
`measurement system, and the like, and/or the BG measure(cid:173)
`ment device may use other methods for measuring the user's
`BG level, such as a sensor in contact with a body fluid, an
`optical sensor, a RF sensor, an enzymatic sensor, a fluores(cid:173)
`cent sensor, a blood sample placed in a receptacle, or the
`like. The BG measurement device may generally be of the
`type and/or include features disclosed in U.S. patent appli(cid:173)
`cations Ser. No. 09/377,472 filed Aug. 19, 1999 and entitled
`"Telemetered Characteristic Monitor System and Method of
`Using the Same," Ser. No. 09/334,996 filed Jun. 17, 1999
`and entitled "Characteristic Monitor with a Characteristic
`Meter and Method of Using the Same," Ser. No. 09/487,423
`filed Jan. 20, 2000 and entitled "Handheld Personal Data
`Assistant (PDA) with a Medical Device and Method of
`Using the Same," and Ser. No. 09/935,827 filed Aug. 23,
`2001 and entitled "Handheld Personal Data Assistant (PDA)
`with a Medical Device and Method of Using the Same,"
`which are herein incorporated by reference. Such BG mea(cid:173)
`surement devices may be adapted to be carried by the user,
`for example, in the hand, on the body, in a clothing pocket,
`attached to clothing ( e.g., using a clip, strap, adhesive, or
`fastener), and the like. In particular embodiments, the BG
`measurement device is sized smaller than 6 inches long by
`4 inches wide by 1 inch thick.
`[0040]
`In alternative embodiments of the invention, the
`BG meter may be integrated into the controller device
`housing, as shown in FIG. 2, where the controller device
`housing 15 includes a BG meter receptacle 20. The control(cid:173)
`ler 10 includes a housing 15 adapted to be carried by the
`user, a BG meter receptacle 20 coupled to the housing 15 for
`receiving and testing BG level from the user to determine a
`concentration of the BG in the user. A BG test st