`
`APPLICATION
`NUMBER
`60/976,886
`
`FILING or
`37l(c)DATE
`10/02/2007
`
`GRPART
`UNIT
`
`FIL FEE REC'D
`210
`
`35884
`LEE, HONG, DEGERMAN, KANG & SCHMADEKA
`660 S. FIGUEROA STREET
`Suite 2300
`LOS ANGELES, CA 90017
`
`UKITED STATES DEPARTME.\IT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIO'JER FOR PATENTS
`P.O. Box 1450
`Alexandria, V:irgmia 22313-1450
`\V½w.uspto.gov
`
`ATTY.DOCKET.NO
`2164-3003Pl
`
`TOT CLAIMS IND CLAIMS
`
`CONFIRMATION NO. 6305
`FILING RECEIPT
`
`111111111111111111111111i~!1~i~1i~1i~1!~i 11mH111111111111111111111111
`
`Date Mailed: 10/22/2007
`
`Receipt is acknowledged of this provisional patent application. It will not be examined for patentability and will
`become abandoned not later than twelve months after its filing date. Any correspondence concerning the application
`must include the following identification information: the U.S. APPLICATION NUMBER, FILING DATE, NAME OF
`APPLICANT, and TITLE OF INVENTION. Fees transmitted by check or draft are subject to collection. Please verify
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`
`Applicant(s)
`
`Himanshu Patel, Northridge, CA;
`Wayne A. Morgan, Northridge, CA;
`Edward Chernoff, Frazier Park, CA;
`John J. Mastrototaro, Los Angeles, CA;
`Power of Attorney:
`Lew Edward Macapagal--55416
`
`If Required, Foreign Filing License Granted: 10/16/2007
`The country code and number of your priority application, to be used for filing abroad under the Paris Convention,
`is US 60/976,886
`Projected Publication Date: None, application is not eligible for pre-grant publication
`Non-Publication Request: No
`Early Publication Request: No
`Title
`
`Glucose Sensor Transceiver
`
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`application under the Patent Cooperation Treaty (PCT). An international (PCT) application generally has the same
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`LICENSE FOR FOREIGN FILING UNDER
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`Title 35, United States Code, Section 184
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`Title 37, Code of Federal Regulations, 5.11 & 5.15
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`GRANTED
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`The applicant has been granted a license under 35 U.S.C. 184, if the phrase "IF REQUIRED, FOREIGN FILING
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`page 3 of 3
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`Page 3 of 62
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`PTO/SB/16 (10-05)
`Approved for use through 07/31/2006. 0MB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid 0MB control number.
`PROVISIONAL APPLICATION FOR PATENT COVER SHEET- Page 1 of 2
`This is a request for filing a PROVISIONAL APPLICATION FOR PATENT under 37 CFR 1.53(c).
`Express Mail Label No. __________________________ _
`
`Given Name (first and middle [if any])
`
`INVENTOR(S)
`Family Name or Surname
`
`Residence
`(City and either State or Forei~n Country)
`
`Himanshu
`
`Wayne A.
`
`Edward
`
`John J.
`
`PATEL
`
`MORGAN
`
`CHERNOFF
`
`MASTROTOTARO
`
`Northridge, CA
`
`Northridge, CA
`
`Frazier Park, CA
`
`Los Angeles, CA
`
`separately numbered sheets attached hereto
`Additional inventors are being named on the
`TITLE OF THE INVENTION (500 characters max):
`
`Glucose Sensor Transceiver
`
`Direct all correspondence to:
`
`CORRESPONDENCE ADDRESS
`
`0 The address corresponding to Customer Number:
`OR
`□ Firm or
`
`Individual Name
`Address
`
`I
`
`035884
`
`I
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`City
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`Country
`
`State
`
`Telephone
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`Zip
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`
`ENCLOSED APPLICATION PARTS (check all that apply)
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`D Application Data Sheet. See 37 CFR 1.76
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`Fees Due: Filing Fee of $200 ($100 for small entity). If the specification and drawings exceed 100 sheets of paper, an application size fee is
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`PROVISIONAL APPL/CATION COVER SHEET
`Page 2 of 2
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`PTO/SB/16 (10-05)
`Approved for use through 07/31/2006. 0MB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid 0MB control number.
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`The invention was made by an agency of the United States Government or under a contract with an agency of the United States Government.
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`
`SIGNATURE /Lew Edward V. Macapagal/
`
`Date October 2, 2007
`
`TYPED or PRINTED NAME _L_e_w_E_d_w_a_rd_V_. _M_a_ca~p_a~g~a_l ___________ _
`
`REGISTRATION NO.5=5~4~1~6~----(cid:173)
`(if appropriate)
`
`TELEPHONE 213-623-2221
`
`Docket Number: _2_16_4_-_3_00_3_P_1 _________ _
`
`Page 5 of 62
`
`
`
`PROVISIONAL APPLICATION FOR
`UNITED STATES PATENT
`IN THE NAMES OF
`
`Himanshu PATEL, Wayne A. MORGAN, Edward CHERNOFF
`andJohnJ.MASTROTOTARO
`
`for
`
`Glucose Sensor Transceiver
`
`prepared by:
`
`Lee, Hong, Degerman, Kang & Schmadeka P .C.
`
`Customer Number 035884
`
`Attorney Docket No.: 2164-3003P1
`
`Total Number of Pages: 53 (including cover)
`
`Page 6 of 62
`
`
`
`Attorney Docket No.
`2164-3003Pl
`
`TITLE
`Glucose Sensor Transceiver
`
`FIELD
`
`[0001]
`
`The present invention relates to telemetered subcutaneous sensor devices and,
`
`more particularly, to devices for wireless communication between an implantable subcutaneous
`
`sensor set at a selected insertion site within the body of a user and at least one of a plurality of
`
`remotely located therapy-related devices.
`
`BACKGROUND
`
`[0002]
`
`Diabetes mellitus is the most common of endocrine disorders, and is characterized
`
`by inadequate insulin action. Diabetes mellitus has two principal variants, known as Type 1
`
`diabetes and Type 2 diabetes. The latter is also referred to as DM/II ( diabetes mellitus type 2),
`
`adult-onset diabetes, maturity-onset diabetes, or NIDDM (non-insulin dependent diabetes
`
`mellitus).
`
`[0003]
`
`Over the years, body characteristics have been determined by obtaining a sample
`
`of bodily fluid. For example, diabetics often test for blood glucose levels. Traditional blood
`
`glucose determinations have utilized a finger prick method using a lancet to withdraw a small
`
`blood sample. These systems are designed to provide data at discrete points but do not provide
`
`continuous data to show variations in the characteristic between testing times. These discrete
`
`measurements are capable of informing a patient the state of his blood glucose values at a point
`
`in time. Thus, the patient has enough information to administer "correction" amounts of insulin
`
`to reduce his current blood glucose reading. However, these discrete readings are not able to
`
`provide enough information for any type of automatic or semi-automatic system of administering
`
`insulin based on blood glucose values.
`
`[0004]
`
`Recently, a variety of implantable electrochemical sensors have been developed
`
`for detecting and/or quantifying specific agents or compositions in a patient's blood or interstitial
`
`fluid. For instance, glucose sensors are being developed for use in obtaining an indication of
`
`blood glucose levels in a diabetic patient. These glucose sensors connected (wired or wirelessly)
`
`1
`
`Page 7 of 62
`
`
`
`Attorney Docket No.
`2164-3003Pl
`
`to a blood glucose monitor can provide continuous glucose readings over a period of time, such
`
`as 3 to 5 days. Such readings are useful in monitoring and/or adjusting a treatment regimen
`
`which typically includes the regular administration of insulin to the patient.
`
`[0005]
`
`Thus, blood glucose readings improve medical therapies with semi-automated
`
`medication infusion pumps of the external type, as generally described in U.S. Patent Nos.
`
`4,562,751; 4,678,408; and 4,685,903; or automated implantable medication infusion pumps, as
`
`generally described in U.S. Patent No. 4,573,994, which are herein incorporated by reference.
`
`Typical thin film sensors are described in commonly assigned U.S. Patent Nos. 5,390,671;
`
`5,391,250; 5,482,473; and 5,586,553 which are incorporated by reference herein. See also U.S.
`
`Patent No. 5,299,571. In addition, characteristic glucose monitors used to provide continuous
`
`glucose data are described in commonly assigned U.S. Patent Application No. 11/322,568
`
`entitled "Telemetered Characteristic Monitor System and Method of Using the Same" filed on
`
`December 30, 2005, which is herein incorporated by reference in its entirety. In addition,
`
`infusion pumps receiving sensor data are described in commonly assigned U.S. Patent
`
`Application No. 10/867,529 entitled "System for Providing Blood Glucose Measurements to an
`
`Infusion Device" filed on October 14, 2004, which is herein incorporated by reference in its
`
`entirety.
`
`[0006]
`
`However, drawbacks associated with a prior glucose sensor system are that a
`
`sensor transmitter is only capable of one-way communication and has limited processing power.
`
`Hence, the sensor transmitter can transmit raw sensor data but is unable to receive therapy(cid:173)
`
`related information from a remote therapy-related device. Moreover, the sensor transmitter is
`
`unable to calculate sensor blood glucose values. Accordingly, in the prior glucose sensor
`
`system, it is necessary to couple the sensor transmitter to a remote data receiving device, such as
`
`a characteristic monitor, to determine actual glucose sensor readings. Moreover, when data is
`
`lost because of a failed transmission, the transmitter does not know to re-transmit because it
`
`cannot be informed of the lost data. Therefore, what is needed is a sensor transceiver for use
`
`with a blood glucose sensor that is capable of transmitting and receiving therapy-related data and
`
`independently calculating sensor blood glucose values.
`
`2
`
`Page 8 of 62
`
`
`
`Attorney Docket No.
`2164-3003Pl
`
`SUMMARY
`
`[0007]
`
`The present invention relates to a telemetered characteristic sensor transceiver for
`
`exchanging data with at least one remote device. The transceiver comprising a housing, a sensor
`
`connector coupling the housing to a sensor located on a body of a user for producing a signal
`
`indicative of a user characteristic, a processor formed within the housing and coupled to the
`
`sensor connector for processing the signal received from the sensor, a transmitter coupled to the
`
`processor for transmitting data to at least one remote device, a receiver coupled to the processor
`
`for receiving data from the at least one remote device, and a memory coupled to the processor
`
`for storing data. Preferably, the processor performs calculations using at least one of the signal
`
`received from the sensor, the data received from the at least one remote device and the data
`
`stored in the memory, and stores the calculations in the memory or transmits the calculations to
`
`the at least one remote device through the transmitter.
`
`[0008]
`
`In accordance with an embodiment of the present invention, the transceiver
`
`exchanges data with a plurality of remote devices in a network structure. In one aspect, the
`
`transceiver exchanges data with the at least one remote device in a synchronous manner.
`
`[0009]
`
`In accordance with another embodiment, the transceiver wakes up from a sleep
`
`mode prior to exchanging data with the at least one remote device, wherein the at least one
`
`remote device wakes up the transceiver. As such, the transceiver further comprises an ultrasonic
`
`sensor for receiving an ultrasonic signal from the at least one remote device when the at least one
`
`remote device transmits the ultrasonic signal to the transceiver to wake up the transceiver.
`
`Alternatively, the transceiver periodically wakes up independent of the at least one remote
`
`device.
`
`[0010]
`
`In another aspect of the invention, the transceiver exchanges data with the at least
`
`one remote device in an asynchronous manner. Preferably, the data exchanged in the
`
`asynchronous manner comprises at least one of a blood glucose value and a request for glucose
`
`history data.
`
`[0011]
`
`In accordance with an embodiment of the present invention, the data exchanged
`
`between the transceiver and the at least one remote device comprises at least one of device
`
`configuration data, communication link configuration data, adaptive communication
`
`3
`
`Page 9 of 62
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`
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`Attorney Docket No.
`2164-3003Pl
`
`configuration data, glucose history data, and calibration data. Preferably, the device
`
`configuration data comprises at least one of a device identification, user information, and time
`
`information. Preferably, the communication link configuration data comprises at least one of a
`
`communication rate, frequency information, and frequency hopping configuration information.
`
`Preferably, the glucose history data is exchanged according to a time interval. Preferably, the
`
`calibration data comprises at least one of sensor initialization sequence and configuration
`
`information, and dynamic sensor initialization parameters.
`
`[0012]
`
`In accordance with another embodiment of the present invention, the processor
`
`calculates sensor glucose values using at least one of the signal received from the sensor, the
`
`data received from the at least one remote device and the data stored in the memory. Preferably,
`
`a rate of exchanging data between the transceiver and the at least one remote device is
`
`dynamically changed depending on a characteristic of the calculated sensor glucose values.
`
`Preferably, a glucose calculation algorithm for calculating the sensor glucose values is stored in
`
`the memory. Preferably, the processor stores the calculated sensor glucose values in the memory
`
`or transmits the calculated sensor glucose values to the at least one remote device through the
`
`transmitter. Preferably, the calculated sensor glucose values are secured via an encryption
`
`scheme before transmission to the at least one remote device.
`
`[0013]
`
`In accordance with another embodiment of the present invention, the receiver
`
`receives calibration data from the at least one remote device and the processor stores the
`
`received calibration data in the memory. Preferably, the processor performs a calibration using
`
`at least one of the calibration data stored in the memory, the signal received from the sensor and
`
`the calculated glucose sensor values. Preferably, a calibration algorithm for performing the
`
`calibration is stored in the memory.
`
`[0014]
`
`In one aspect of the invention, transceiver comprises a display for displaying
`
`information processed by the processor. In another aspect, the transceiver comprises means for
`
`notifying the user that the at least one remote device is beyond a certain distance from the
`
`transceiver.
`
`[0015]
`
`In a further aspect of the invention, a power for exchanging data between the
`
`transceiver and the at least one remote device is dynamically changed depending on a strength of
`
`a detected signal between the transceiver and the at least one remote device.
`
`4
`
`Page 10 of 62
`
`
`
`[0016]
`
`Other features and advantages of the invention will become apparent from the
`
`following detailed description, taken in conjunction with the accompanying drawings which
`
`illustrate, by way of example, various features of embodiments of the invention.
`
`Attorney Docket No.
`2164-3003Pl
`
`5
`
`Page 11 of 62
`
`
`
`Attorney Docket No.
`2164-3003Pl
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[0017]
`
`A detailed description of embodiments of the invention will be made with
`
`reference to the accompanying drawings, wherein like numerals designate corresponding parts in
`
`the several figures.
`
`[0018]
`
`FIG. 1 is a perspective view illustrating a subcutaneous sensor insertion set and
`
`telemetered characteristic sensor transceiver device embodying the novel features of the
`
`invention.
`
`[0019]
`
`of FIG. 1.
`
`[0020]
`
`FIG. 2 is an enlarged longitudinal vertical section taken generally on the line 2--2
`
`FIG. 3 is an enlarged longitudinal sectional of a slotted insertion needle used in
`
`the insertion set of FIGS. 1 and 2.
`
`[0021]
`
`[0022]
`
`[0023]
`
`FIG. 4 is an enlarged transverse section taken generally on the line 4--4 of FIG. 3.
`
`FIG. 5 is an enlarged transverse section taken generally on the line 5--5 of FIG. 3.
`
`FIG. 6 is an enlarged fragmented sectional view corresponding generally with the
`
`encircled region 6 of FIG. 2.
`
`[0024]
`
`[0025]
`
`FIG. 7 is an enlarged transverse section taken generally on the line 7--7 of FIG. 2.
`
`FIG. 8A is a top plan and partial cut-away view of the telemetered characteristic
`
`sensor transceiver in accordance with the embodiment shown in FIG. 1.
`
`[0026]
`
`FIG. 8B is a simplified block diagram of the printed circuit board of the
`
`telemetered characteristic sensor transceiver in accordance with the embodiments shown in FIG.
`
`1.
`
`[0027]
`
`FIG. 9 is a simplified block diagram of a telemetered characteristic sensor
`
`transceiver and sensor set system in accordance with another embodiment of the present
`
`invention.
`
`[0028]
`
`FIG. 10 is a simplified block diagram of a telemetered characteristic sensor
`
`transceiver and characteristic monitor system in accordance with still another embodiment of the
`
`present invention.
`
`6
`
`Page 12 of 62
`
`
`
`Attorney Docket No.
`2164-3003Pl
`
`[0029]
`
`FIG. 11 is a block diagram of a telemetered characteristic sensor transceiver
`
`communicating with a variety of remote electronic devices in a network structure in accordance
`
`with another embodiment of the present invention.
`
`[0030]
`
`FI GS. 12-19 illustrate alternative embodiments of the telemetered characteristic
`
`sensor transceiver in accordance with preferred embodiments of the present invention.
`
`7
`
`Page 13 of 62
`
`
`
`Attorney Docket No.
`2164-3003Pl
`
`DETAILED DESCRIPTION
`
`[0031]
`
`As shown in the drawings for purposes of illustration, the invention is embodied
`
`in a telemetered characteristic sensor transceiver coupled to a sensor set, that may be implanted
`
`in and/or through subcutaneous, dermal, sub-dermal, inter-peritoneal or peritoneal tissue, that not
`
`only transmits data from the sensor set to a remote therapy-related device, such as a
`
`characteristic monitor for determining body characteristics, but may also receive data from the
`
`remote device. Although the telemetered characteristic sensor transceiver of the present
`
`invention is described below with regard to a characteristic monitor in particular, the transceiver
`
`need not be coupled to such a device alone. The present invention contemplates the transceiver
`
`operating with other remote electronic devices, such as infusion pumps, monitors, personal
`
`computers and hospital system devices, for example. Moreover, the transceiver may be linked to
`
`a single electronic device or numerous devices in a network structure.
`
`[0032]
`
`In preferred embodiments of the present invention, the sensor set and monitor are
`
`for determining glucose levels in the blood and/or body fluids of the user without the use of, or
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`necessity of, a wire or cable connection between the transceiver and the monitor. However, it
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`will be recognized that further embodiments of the invention may be used to determine the levels
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`of other agents, characteristics or compositions, such as hormones, cholesterol, medication
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`concentrations, pH, oxygen saturation, viral loads ( e.g., HIV), or the like.
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`[0033]
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`In other embodiments, the sensor set may also include the capability to be
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`programmed or calibrated using data received and stored by the telemetered characteristic sensor
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`transceiver, or may be calibrated at the monitor (or receiver). The telemetered characteristic
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`sensor system is primarily adapted for use in subcutaneous human tissue. However, still further
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`embodiments may be placed in other types of tissue, such as muscle, lymph, organ tissue, veins,
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`arteries or the like, and used in animal tissue. Embodiments may provide sensor values to and/or
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`receive therapy-related information from a remote device on an intermittent or continuous basis.
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`[0034]
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`FIG. 1 is a perspective view illustrating a subcutaneous sensor insertion set and
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`telemetered characteristic sensor transceiver device embodying the novel features of the
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`invention. FIG. 2 is an enlarged longitudinal vertical section taken generally on the line 2--2 of
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`FIG. 1. Referring to FIGS. 1 and 2, a telemetered characteristic sensor system 1, in accordance
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`8
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`Attorney Docket No.
`2164-3003Pl
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`with a preferred embodiment of the present invention includes a percutaneous sensor set 10, a
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`telemetered characteristic sensor transceiver device 100 and a characteristic monitor 200.
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`Preferably, the telemetered characteristic sensor system 1 provides for better treatment and
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`glycemic control in an outpatient or home-use environment. For example, the sensor system 1
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`can provide indications of glucose levels, hypoglycemia/hyperglycemia alerts and outpatient
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`diagnostics. It is also useful as an evaluation tool under a physician's supervision.
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`[0035]
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`The percutaneous sensor set 10 utilizes an electrode-type sensor, as described in
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`more detail below. However, in alternative embodiments, the system may use other types of
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`sensors, such as chemical based, optical based or the like. In further alternative embodiments,
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`the sensors may be of a type that is used on the external surface of the skin or placed below the
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`skin layer of the user. Preferred embodiments of a surface mounted sensor would utilize
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`interstitial fluid harvested from underneath the skin.
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`[0036]
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`The telemetered characteristic sensor transceiver 100 generally includes the
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`capability to transmit and receive data. Preferably, the telemetered characteristic sensor
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`transceiver 100 facilitates two-way communication between the sensor set 10 and the
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`characteristic monitor 200. The sensor transceiver 100 also includes the ability to determine the
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`characteristic reading using raw data received from the sensor set 10. The characteristic monitor
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`200 can also determine the characteristic reading using data transmitted from the transceiver 100.
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`[0037]
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`In alternative embodiments, the characteristic monitor 200 may be replaced with a
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`data receiver, storage and/or transmitting device for later processing of the transmitted data or
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`programming of the telemetered characteristic monitor transceiver 100. In further embodiments,
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`the telemetered characteristic sensor transceiver 100 can maintain multiple two-way
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`communication links with other devices, such as infusion pumps, monitors, personal computers
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`and hospital system devices, for example.
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`[0038]
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`In addition, referring to FIG. 9, a relay or repeater 4 may be used with the
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`telemetered characteristic sensor transmitter 100 and the characteristic monitor 200 to increase
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`the distance that the telemetered characteristic sensor transceiver 100 can be used with the
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`characteristic monitor 200. For example, the relay 4 could be used to provide information to
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`parents of children using the telemetered characteristic sensor transceiver 100 and the sensor set
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`10 from a distance. The information could be used when children are in another room during
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`sleep or doing activities in a location remote from the parents. In further embodiments, the relay
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`9
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`2164-3003Pl
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`4 can include the capability to sound an alarm. In addition, the relay 4 may be capable of
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`providing telemetered characteristic sensor transceiver 100 data from the sensor set 10, as well
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`as other data, to a remotely located individual via a modem connected to the relay 4 for display
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`on a monitor, pager or the like. The relay 4 may also be used to transfer information from a
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`remote device to the transceiver 100.
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`[0039]
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`Referring to FIG. 10, data may be exchanged between the transceiver 100 and a
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`remotely located computer 6 such as a personal computer (PC), personal digital assistant (PDA),
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`or the like, through a communication station 8 over communication lines ( e.g., modem or
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`wireless connection). In some embodiments, the communication station 8 may be omitted such
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`that the transceiver 100 directly connects to the computer 6 via the modem or wireless
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`connection. In further embodiments, the telemetered characteristic sensor transceiver 100
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`connects to an RF programmer, which acts as a relay, or shuttle, for data communication
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`between the sensor set 10 and a PC, PDA, communication station, data processor, or the like. In
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`further alternatives, t