(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2008/0097246 A1
`Stafford
`(43) Pub. Date:
`Apr. 24, 2008
`
`US 2008.0097246A1
`
`(54) METHOD AND SYSTEM FOR PROVIDING
`AN INTEGRATED ANALYTE SENSOR
`INSERTON DEVICE AND DATA
`PROCESSING UNIT
`
`(75) Inventor:
`
`Gary Ashley Stafford, Hayward,
`CA (US)
`
`Correspondence Address:
`JACKSON & CO., LLP
`6114 LASALLEAVENUE, #507
`OAKLAND, CA 94611-2802
`(73) Assignee:
`Abbott Diabetes Care, Inc,
`Alameda, CA (US)
`
`(21) Appl. No.:
`
`11/530,472
`
`(22) Filed:
`
`Sep. 10, 2006
`
`Publication Classification
`
`(51) Int. Cl.
`A6B IO/00
`
`(2006.01)
`
`(52) U.S. Cl. ....................................................... 6OO/584
`
`ABSTRACT
`(57)
`Method and apparatus for providing an integrated analyte
`sensor and data processing unit assembly is provided.
`
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`Patent Application Publication
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`Patent Application Publication
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`Patent Application Publication
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`Patent Application Publication
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`Apr. 24, 2008 Sheet 5 of 5
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`US 2008/0097246 A1
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`INTEGRATED ANALYE
`SENSOR AND DATA
`PROCESSING UNIT
`
`DATAANALYSIS UNIT
`
`DATAPROCESSSING
`ERMINAL
`
`FLUIDELIWRY UNIT
`
`600
`
`FIGURE 6
`
`
`
`ANALYTE
`SNSOR
`MANUFACTURING
`ECUPMN
`NTERFACE
`
`ANAOG
`NTERFACE
`
`SERA
`COMMUNICATION
`SECTION
`
`USERNPUT
`
`PROCESSOR
`
`RF TRANSCEIVER
`
`TODATA
`ANALYSS UNIT
`630
`
`TEMPERATURE
`MEASUREMENT
`SECTION
`
`POWERSUPPLY
`
`610
`
`FIGURE 7
`
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`US 2008/0097246 A1
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`Apr. 24, 2008
`
`METHOD AND SYSTEM FOR PROVIDING
`AN INTEGRATED ANALYTE SENSOR
`INSERTON DEVICE AND DATA
`PROCESSING UNIT
`
`BACKGROUND
`
`0001 Analyte monitoring systems generally include a
`sensor Such as a Subcutaneous analyte sensor, at least a
`portion of which is inserted under the skin for fluid contact
`with interstitial fluid, for detecting analyte levels such as
`glucose levels, a transmitter (Such as an RF transmitter) in
`communication with the sensor and configured to receive the
`sensor signals and to transmit them to a corresponding
`receiver unit by for example, using RF data transmission
`protocol. The receiver may be operatively coupled to a
`glucose monitor that performs glucose related calculations
`and data analysis.
`0002 The transmitter is in signal communication with the
`sensor. Generally, the sensor is configured to detect and
`measure the glucose levels of the patient over a predeter
`mined period of time, and the transmitter is configured to
`transmit data corresponding to or associated with the mea
`sured glucose levels over the predetermined period of time
`for further analysis. To initially deploy the sensor so that the
`sensor electrodes are in fluid contact with the patients
`analyte fluids, a separate deployment mechanism Such as a
`sensor inserter or introducer is used. More specifically, the
`introducer includes a sharp needle shaped inserter that is
`configured to pierce through the skin of the patient and
`Substantially concurrently guide the sensor through the
`patient’s skin so as to place at least a portion of the sensor
`in fluid contact with the target biological fluid of the patient.
`0003. The inserter is typically used only during the sensor
`insertion process, and once the sensor is properly and
`accurately positioned, the inserter and the introducer are
`discarded. This requires a level of care as the inserter is
`sharp and may damage other parts of the patient’s skin if not
`properly handled. Further, since the tip of the inserter has
`come into fluid contact with the patient’s biological fluids,
`it is important to take particular precautions in the handling
`of the inserter.
`0004 Further, to minimize data errors in the continuous
`or semi-continuous monitoring system, it is important to
`properly insert the sensor through the patient’s skin and
`securely retain the sensor during the time that the sensor is
`configured to detect analyte levels. Additionally, for the
`period of continuous or semi-continuous monitoring which
`can include, for example, 3 days, 5 days or 7 days, it is
`important to have the transmitter in proper signal contact
`with the analyte sensorso as to minimize the potential errors
`in the monitored data.
`0005. In view of the foregoing, it would be desirable to
`have method and apparatus for providing simple, easy to
`handle and accurate sensor introduction and retention
`mechanism for use in an analyte monitoring system. More
`specifically, it would be desirable to have method and
`apparatus that minimizes the number of components which
`the patient has to handle, and which also reduces the number
`
`of required steps to properly and accurately position the
`analyte sensor in fluid contact with the patients analytes.
`
`SUMMARY OF THE INVENTION
`
`0006 An integrated assembly in accordance with one
`embodiment of the present invention includes a housing, a
`data processing unit Substantially disposed within the hous
`ing, an introducer removably coupled to the housing, at least
`a portion of the introducer disposed within the housing, and
`an analyte sensor coupled to the housing, a first portion of
`the analyte sensor configured for Subcutaneous placement
`and in fluid contact with an interstitial fluid of a subject, and
`a second portion of the analyte sensor disposed within the
`housing and in electrical communication with the data
`processing unit.
`0007. In the manner described, within the scope of the
`present invention, the integrated analyte sensor and data
`processing unit assembly in accordance with the various
`embodiments is configured to integrate an analyte sensor, a
`sensor introducer mechanism, and a data processing device
`into a single assembly which is may be disposable, and
`which allows for simple and accurate sensor deployment to
`the desired Subcutaneous position, and that may be easily
`operated using one hand by the user or the patient.
`0008. These and other features and advantages of the
`present invention will be understood upon consideration of
`the following detailed description of the invention and the
`accompanying drawings.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`0009 FIG. 1 illustrates a side view of the overall assem
`bly of an integrated analyte sensor delivery and data pro
`cessing unit in accordance with one embodiment of the
`present invention;
`0010 FIG. 2 illustrates a side view of the integrated
`analyte sensor delivery and data processing unit of FIG. 1
`without a protective guard in accordance with one embodi
`ment of the present invention;
`(0011
`FIGS. 3A-3C illustrate a perspective view, a top
`planar view and a bottom planar view, respectively of the
`integrated analyte sensor delivery and data processing unit
`of FIG. 1 in accordance with one embodiment of the present
`invention;
`0012 FIG. 4A illustrates the integrated analyte sensor
`delivery and data processing unit of FIG. 1 with the intro
`ducer removed in accordance with one embodiment;
`0013 FIG. 4B illustrates the integrated analyte sensor
`delivery and data processing unit without the introducer in
`accordance with one embodiment of the present invention;
`0014 FIG. 5A illustrates the introducer and the analyte
`sensor assembly with the protective guard in accordance
`with one embodiment of the present invention;
`(0015 FIGS. 5B-5C illustrate a side view and a perspec
`tive view, respectively, of the introducer and analyte sensor
`assembly in accordance with one embodiment of the present
`invention;
`0016 FIG. 6 illustrates a block diagram of an analyte
`monitoring system with integrated analyte sensor delivery
`and data processing unit in accordance with one embodi
`ment of the present invention; and
`
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`Apr. 24, 2008
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`0017 FIG. 7 illustrates a block diagram of the data
`processing unit of the integrated analyte sensor delivery and
`data processing unit in accordance with one embodiment of
`the present invention.
`
`DETAILED DESCRIPTION
`0.018. In accordance with the various embodiments of the
`present invention, there is provided an integrated analyte
`sensor delivery and data processing unit for Subcutaneous
`placement of an analyte sensor for fluid contact with an
`analyte of a subject for analyte monitoring, and data pro
`cessing associated with the monitored analyte levels. More
`specifically, the integrated analyte sensor delivery and data
`processing unit in accordance with one embodiment of the
`present invention provides simple, easy to use analyte sensor
`placement for analyte monitoring and associated data pro
`cessing without a direct line of sight visual aid, and also,
`which may be easily performed without the use of both
`hands.
`FIG. 1 illustrates a side view of the overall assem
`0.019
`bly of an integrated analyte sensor delivery and data pro
`cessing unit in accordance with one embodiment of the
`present invention. Referring to FIG. 1, in one embodiment,
`an integrated analyte sensor delivery and data processing
`unit assembly 100 includes a data processing unit 101
`provided on an upper surface of an adhesive patch 103 as
`shown. The adhesive patch 103 in one embodiment is
`provided with an adhesive material. Such as, for example,
`polyester or acrylic based adhesives or any other suitable
`material which are biocompatible providing sufficient adhe
`sive strength, on its bottom Surface that is configured to
`securely attach the adhesive patch 103 and the data process
`ing unit 101 on a surface of a Subject Such as the skin of a
`patient.
`0020 Referring to FIG. 1, also provided is a temperature
`module 105 to be in physical contact with the surface of the
`Subject to, among others, detect the temperature, as further
`discussed in further detail below in conjunction with tem
`perature measurement section 703 of FIG. 7. Referring again
`to FIG. 1, the integrated sensor delivery and data processing
`unit assembly 100 in one embodiment also includes an
`introducer having an upper portion 102A and a lower portion
`102B. The upper and lower portions 102A, 102B of the
`introducer in one embodiment is coupled to the housing of
`the data processing unit 101 Such that the upper portion
`102A of the introducer protrudes from an upper surface of
`the data processing unit 101, while the lower portion 102B
`of the introducer is configured to protrude downwardly from
`the bottom surface of the data processing unit 101 as can be
`seen in FIG. 1.
`0021. As shown in FIG. 1, the upper portion 102A of the
`introducer is configured to guide the user to insert the
`introducer through the surface of the subject such as the skin
`of the patient. Thus, the upper portion 102A of the introducer
`in one embodiment is provided with a larger Surface area
`(that is, for example, a larger diameter) to apply force
`thereon, while the lower portion 102B of the introducer is
`configured with a sharp tip to facilitate puncturing or pierc
`ing through the Surface of the Subject Such as the skin of the
`patient. For example, in one embodiment,
`0022. Additionally, in one aspect, there is provided a
`guard segment 104 in the integrated analyte sensor and data
`processing unit assembly 100 Such that the guard segment
`104 is configured to substantially cover the lower portion
`
`102B of the introducer. In one embodiment, the guard
`segment 104 is configured as a protective needle guard so as
`to maintain the lower portion 102B of the introducer in a
`Substantially sterile environment prior to Subcutaneous
`placement through the Surface of the Subject such as the skin
`of the patient. Moreover, in one aspect, the guard segment
`104 is configured to protect the sharp edge of the lower
`portion 102B of the introducer from inadvertent contact with
`the Subject, for example, prior to the Subcutaneous deploy
`ment of the analyte sensor to avoid, for example, contami
`nation of the lower portion 102B of the introducer, or
`potential injury from the sharp edge of the power portion
`102B of the introducer.
`0023. More specifically, FIG. 2 illustrates a side view of
`the integrated analyte sensor delivery and data processing
`unit of FIG. 1 without a guard segment in accordance with
`one embodiment of the present invention. Referring to FIG.
`2, with the guard segment 104 removed, it can be seen that
`in one embodiment, analyte sensor 106 is provided in the
`integrated analyte sensor delivery and data processing unit
`100 such that the at least a portion of the analyte sensor 106
`is disposed within the lower portion 102B of the introducer.
`0024. In one embodiment, the patient or the user of the
`integrated analyte sensor delivery and data processing unit
`assembly 100 removes the guard segment 104 to expose the
`lower portion 102B of the introducer, and thereafter, places
`the entire analyte sensor delivery and data processing unit
`assembly 100 on the surface of the subject such as the skin
`layer of the patient with sufficient force applied on the upper
`surface of the data processing unit 101 such that the lower
`portion 102B of the introducer is pierced through the skin
`layer of the patient. Thereafter, the introducer may be
`removed to detach or decouple from the data processing unit
`101 by, for example, pulling at the upper portion 102A of the
`introducer, thereby withdrawing the introducer from the
`patient and separating from the data processing unit 101,
`while retaining the analyte sensor 106 (FIG. 2) in position in
`fluid contact with the patients analyte.
`0025 Referring again to FIGS. 1 and 2, in one embodi
`ment, the bottom layer of the adhesive patch 103 may be
`provided with a protective layer (not shown) which the
`patient or the user of the integrated analyte sensor delivery
`and data processing unit assembly 100 removes (for
`example, by peeling off to detach from the bottom surface of
`the adhesive patch 103 and thus exposing the adhesive
`material on the bottom surface of the adhesive patch 103)
`prior to Subcutaneously positioning the analyte sensor in the
`patient. For example, in one embodiment, the guard segment
`104 may be first removed and the protective layer removed
`before use, or alternatively, the removal of the protective
`layer may be configured to remove or detach the guard
`segment 104 therewith. In an alternate embodiment, the
`protective layer and the guard segment 104 may be formed
`as a single integrated unit for ease of use.
`(0026 FIGS. 3A-3C illustrate a perspective view, a top
`planar view and a bottom planar view, respectively of the
`integrated analyte sensor delivery and data processing unit
`of FIG. 1 in accordance with one embodiment of the present
`invention. Referring now to FIG. 4A, the removal of the
`introducer is shown. More specifically, FIG. 4A illustrates
`the integrated analyte sensor delivery and data processing
`unit of FIG. 1 with the introducer removed, and FIG. 4B
`illustrates the integrated analyte sensor delivery and data
`processing unit without the introducer in accordance with
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`
`one embodiment of the present invention. That is, in one
`embodiment, upon placement of the integrated analyte sen
`sor delivery and data processing unit assembly 100 on the
`skin Surface of the patient, for example, the patient retracts
`or pulls the introducer Substantially at the upper portion
`102A in the direction substantially perpendicular and away
`from the data processing unit 101 as shown by the direc
`tional arrow 401.
`0027. When the introducer is removed, in one embodi
`ment, the entire introducer including the upper portion 102A
`and the lower portion 102B is withdrawn from the housing
`of the data processing unit 101 to completely separate from
`the data processing unit. Moreover, the portion of the analyte
`sensor 106 is retained in the Subcutaneous position so as to
`maintain fluid contact with the patients analyte. In one
`embodiment, the housing of the transmitter unit 101 is
`provided with a self-sealing aperture (not shown) through
`which the introducer may be removed, such that, when the
`introducer is withdrawn, there is no opening or aperture on
`the data processing unit 101 housing where moisture or
`contaminant may compromise the functions and operations
`of the data processing unit 101. Optionally, while not shown,
`a protective layer may be provided over the integrated
`analyte sensor delivery and data processing unit 100 upon
`positioning on the skin of the patient to provide protection
`from water, moisture or any other potential contaminants
`potentially damaging the integrated analyte sensor delivery
`and data processing unit 100.
`0028 FIG. 5A illustrates the introducer and the analyte
`sensor assembly with the protective guard, and FIGS. 5B-5C
`illustrate a side view and a perspective view, respectively, of
`the introducer and analyte sensor assembly in accordance
`with one embodiment of the present invention. As shown in
`the Figures, the integrated analyte sensor delivery and data
`processing unit 100 in one embodiment may be pre-as
`sembled as a single integrated unit with the analyte sensor
`106 in electrical contact with the data processing unit 101,
`and further, where a portion of the analyte sensor 106 is
`disposed within the lower portion 102B of the introducer
`Such that, the user or patient may easily, and accurately
`position the analyte sensor 106 under the skin layer to
`establish fluid contact with the patients analyte, and there
`after, to provide the detected analyte levels from the analyte
`sensor 106 to the data processing unit 101.
`0029 FIG. 6 illustrates a block diagram of an analyte
`monitoring system with integrated analyte sensor delivery
`and data processing unit in accordance with one embodi
`ment of the present invention. Referring to FIG. 6, a data
`monitoring and management system 600 Such as, for
`example, analyte (e.g., glucose) monitoring and manage
`ment system in accordance with one embodiment of the
`present invention is shown. The subject invention is further
`described primarily with respect to a glucose monitoring
`system for convenience and Such description is in no way
`intended to limit the scope of the invention. It is to be
`understood that the analyte monitoring system may be
`configured to monitor a variety of analytes, e.g., lactate, and
`the like.
`0030 Analytes that may be monitored include, for
`example, acetyl choline, amylase, bilirubin, cholesterol,
`chorionic gonadotropin, creatine kinase (e.g., CK-MB), cre
`atine, DNA, fructosamine, glucose, glutamine, growth hor
`mones, hormones, ketones, lactate, peroxide, prostate-spe
`cific antigen, prothrombin, RNA, thyroid stimulating
`
`hormone, and troponin. The concentration of drugs, such as,
`for example, antibiotics (e.g., gentamicin, Vancomycin, and
`the like), digitoxin, digoxin, drugs of abuse, theophylline,
`and warfarin, may also be monitored.
`0031. The data monitoring and management system 600
`in one embodiment includes an integrated analyte sensor and
`data processing unit 610, a data analysis unit 630 which is
`configured to communicate with the integrated analyte sen
`sor and data processing unit 610 via a communication link
`620. The data analysis unit 630 may be further configured to
`transmit and/or receive data to and/or from a data processing
`terminal 650 via communication link 640. The data process
`ing terminal 650 in one embodiment may be configured for
`evaluating the data received by the data analysis unit 630.
`0032 Referring again to FIG. 6, also shown is a fluid
`delivery unit 670 which is operatively coupled to the data
`processing terminal 650 via communication link 680, and
`further operatively coupled to the data analysis unit 630 via
`communication link 660, and also, operatively coupled to
`the integrated analyte sensor and data processing unit 610
`via communication link 690. In one embodiment, the fluid
`delivery unit 670 may include an external or implantable
`infusion device Such as an insulin infusion pump, or the like,
`which may be configured to administer insulin to patients,
`and which may be configured to determine Suitable modi
`fications or updates to the medication dispensing profile
`based on data received from one or more of the integrated
`analyte sensor and data processing unit 610, data analysis
`unit 630, or data processing terminal 650, for example, for
`administering and modifying basal profiles, as well as for
`determining appropriate boluses for administration based
`on, among others, the detected analyte levels received from
`the integrated analyte sensor and data processing unit 610.
`0033. Furthermore, referring again to FIG. 6, the one or
`more of the communication links 620, 640, 680, and 690
`may be configured as one or more of a wired or a wireless
`communication link, for example, including but not limited
`to RS232 cable connection, a Universal Serial Bus (USB)
`connection, an RF communication link, an infrared commu
`nication link, a Bluetooth enabled communication link, an
`802.11X wireless communication link, or an equivalent
`wireless communication protocol which would allow secure,
`wireless communication of several units (for example, per
`HIPPA requirements) while avoiding potential data collision
`and interference.
`0034 Moreover, it will be appreciated by one of ordinary
`skill in the art that the data monitoring and management
`system 600 may include one or more integrated analyte
`sensor and data processing unit 610, one or more data
`analysis unit 630, one or more fluid delivery unit 670 and
`one or more data processing terminal 650. In addition, the
`one or more integrated analyte sensor and data processing
`unit 610, one or more data analysis unit 630, one or more
`fluid delivery unit 670 and one or more data processing
`terminal 650 may be in communication with a remote site
`over a data network Such as the internet for transmitting
`and/or receiving information associated with the functions
`and operations of each device. For example, the one or more
`integrated analyte sensor and data processing unit 610, one
`or more data analysis unit 630, one or more fluid delivery
`unit 670 and one or more data processing terminal 650 may
`be in communication with a data network Such as the
`Internet for retrieving and/or transmitting data from a remote
`server terminal.
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`0035. Furthermore, in one embodiment, in a multi-com
`ponent environment, each device is configured to be
`uniquely identified by each of the other devices in the system
`so that communication conflict is readily resolved between
`the various components within the data monitoring and
`management system 100.
`0036. In one embodiment of the present invention, the
`sensor 106 is physically positioned in or on the body of a
`user whose analyte level is being monitored. The sensor 106
`may be configured to continuously sample the analyte level
`of the user and convert the sampled analyte level into a
`corresponding data signal for transmission by the data
`processing unit 101. More specifically, in one embodiment,
`the data processing unit 101 may be configured to perform
`data processing Such as filtering and encoding of data
`signals, each of which corresponds to a sampled analyte
`level of the user, for transmission to the data analysis unit
`630 via the communication link 620.
`0037. In one embodiment, the communication link 620
`may be configured as a one-way RF communication path
`from the integrated analyte sensor and data processing unit
`610 to the data analysis unit 630. In such embodiment, the
`data processing unit 101 of the integrated analyte sensor and
`data processing unit 610 is configured to transmit the
`sampled data signals received from the sensor 106 without
`acknowledgement from the data analysis unit 630 that the
`transmitted sampled data signals have been received. For
`example, the data processing unit 101 may be configured to
`transmit the encoded sampled data signals at a fixed rate
`(e.g., at one minute intervals) after the completion of the
`initial power on procedure. Likewise, the data analysis unit
`630 may be configured to detect the encoded sampled data
`signals transmitted from the data processing unit 101 at
`predetermined time intervals. Alternatively, the communi
`cation link 620 may be configured with a bi-directional RF
`(or otherwise) communication between the data processing
`unit 101 and the data analysis unit 630.
`0038 Referring again to FIG. 6, in one embodiment, the
`data processing terminal 650 may include a personal com
`puter, a portable computer Such as a laptop or a handheld
`device (e.g., personal digital assistants (PDAs)), and the
`like, each of which may be configured for data communi
`cation with the receiver via a wired or a wireless connection.
`Additionally, the data processing terminal 650 may further
`be connected to a remote data network Such as over the
`Internet (not shown) for storing, retrieving and updating data
`corresponding to the detected analyte level of the user and/or
`therapy related information Such as medication delivery
`profiles prescribed by a physician, for example.
`0039 FIG. 7 illustrates a block diagram of the data
`processing unit of the integrated analyte sensor delivery and
`data processing unit in accordance with one embodiment of
`the present invention. Referring to FIGS. 1 and 7, the data
`processing unit 101 (FIG. 1) in one embodiment includes an
`analog interface 701 configured to communicate with the
`sensor 106 (FIG. 2), a user input 702, and a temperature
`detection section 703, each of which is operatively coupled
`to a data processing unit processor 704 Such as one or more
`central processing units (CPUs) or equivalent microproces
`Sor units.
`0040. Further shown in FIG. 7 are a transmitter serial
`communication section 705 and an RF transceiver 706, each
`of which is also operatively coupled to the processor 704.
`Moreover, a power supply 707 such as a battery is also
`
`provided in the data processing unit 101 to provide the
`necessary power for the components in the data processing
`unit 101. Additionally, as can be seen from the Figure, clock
`708 is provided to, among others, supply real time informa
`tion to the processor 704.
`0041
`Referring back to FIG. 7, the power supply section
`707 in one embodiment may include a rechargeable battery
`unit that may be recharged by a separate power Supply
`recharging unit (for example, provided in the data analysis
`unit 630 (FIG. 6)) so that the data processing unit 101 may
`be powered for a longer period of usage time. In addition,
`the temperature measurement (or detection) section 703 of
`the transmitter unit 102 is configured to monitor the tem
`perature of the skin near the sensor insertion site. The
`temperature reading may be used to adjust the analyte
`readings obtained from the analog interface 701.
`0042. In this manner, in one embodiment, the sensor
`detected analyte levels are provided to the data processing
`unit 101 of the integrated analyte sensor and data processing
`unit 100 (FIG. 1), for example, as current signals, and which
`are in turn, converted to respective digital signals for trans
`mission (including, for example, RF transmission) to the
`data analysis unit 630, fluid delivery unit 670, and/or the
`data processing terminal 650 for further processing and
`analysis (including drug (e.g., insulin) therapy management,
`infusion control, and health monitoring and treatment, for
`example). That is, the monitored analyte data may be used
`by the patient and/or the patients healthcare provider to
`modify the patients therapy such as an infusion protocol
`(such as basal profile modifications in the case of diabetics)
`as necessary to improve insulin infusion therapy for diabet
`ics, and further, to analyze trends in analyte levels for
`improved treatment.
`0043. Additional detailed description of the data moni
`toring and management system such as analyte monitoring
`systems, its various components including the functional
`descriptions of data processing unit and data analysis unit
`are provided in U.S. Pat. No. 6,175,752 issued Jan. 16, 2001
`entitled “Analyte Monitoring Device and Methods of Use'.
`and in application Ser. No. 10/745,878 filed Dec. 26, 2003
`entitled “Continuous Glucose Monitoring System and Meth
`ods of Use', each assigned to the Assignee of the present
`application.
`0044. In the manner described above, in one embodi
`ment, the integrated analyte sensor and data processing unit
`assembly is configured to integrate an analyte sensor, a
`sensor introducer mechanism, and a data processing device
`into a single disposable assembly which allows for simple
`and accurate sensor deployment to the desired Subcutaneous
`position, and which may be used with one hand by the user
`or the patient. Accordingly, a separate sensor introducing
`device such as a separate insertion gun or a separate sensor
`delivery mechanism is not necessary.
`0045. Furthermore, by integrating the analyte sensor, the
`introducer as well as the data processing unit into a single
`assembly, it is possible to have a smaller profile, simpler use
`application with less packaging thereby achieving cost
`reduction in manufacturing. Indeed, by reducing the number
`of components needed for sensor placement, within the
`Scope of the present invention, other benefits such as reduc
`tion in material cost, weight, packaging, and associated
`handling and disposal may be achieved.
`0046. An apparatus including an analyte sensor and a
`data processing unit in accordance with one embodiment of
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`US 2008/0097246 A1
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`Apr. 24, 2008
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`the present invention includes a housing, a data processing
`unit coupled to the housing, an introducer removably
`coupled to the housing, the introducer including a first
`portion configured for piercing through a skin layer of a
`Subject, and an analyte sensor coupled to the housing, the
`analyte sensor including a first portion and a second portion,
`the first portion of the analyte sensor coupled to the first
`portion of the introducer, and the second portion of the
`analyte sensor coupled to the data processing unit, where the
`first portion of the analyte sensor is configured for transcu
`taneous placement so as to be in fluid contact with an
`interstitial fluid of the subject, where the second portion of
`the analyte sensor is in electrical contact with the data
`processing unit, and further, where at least a portion of the
`data processing unit, at least a portion of the introducer and
`at least a portion of the analyte sensor are coupled to the
`housing as a single integrated assembly.
`0047. In one embodiment, there is further provided an
`adhesive layer substantially on a lower surface of the
`housing, the adhesive layer configured to removably attach
`the housing to the skin layer of the Subject.
`0048. Additionally, a guard segment may be removably
`coupled to the first portion of the introducer, where the guard
`segment may be configured to Substantially seal the first
`portion of the introducer.
`0049. In a further aspect, the first portion of the intro
`ducer may include a sharp tip for piercing through the skin
`layer of the subject, wherein when the sharp tip is pierced
`through the skin layer, the first portion of the analyte sensor
`is transcutaneously placed under the skin layer of the Subject
`so as to be in fluid contact with the interstitial fluid of the
`Subject.
`0050. In another aspect, the introducer may be configured
`to decouple from the housing after the first portion of the
`analyte sensor is transcutaneously positioned under the skin
`layer of the subject.
`0051. The analyte sensor may include a glucose sensor.
`0052. The data processing unit in one embodiment may
`include a data transmission unit configured to receive one or
`more signals associated with an analyte level of the Subject
`from the analyte sensor, where the data transmission unit
`may be configured to wirelessly transmit data associated
`with the one or more signals received from the analyte
`sensor, where the data transmission unit may include an RF
`data transmission unit.
`0053 An integrated assembly in accordance with another
`embodiment of the present invention includes a housing, a
`data processing u