Analyte monitoring device and methods of use

• US 20040106858A1
• Filed: 11/24/2003
• Published: 06/03/2004
• Est. Priority Date: 04/30/1998
• Status: Abandoned Application

• Current Assignee: Therasense Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Therasense Incorporated (Abbott Laboratories Incorporated)
• Inventors: Heller, Ephraim, Heller, Adam, Say, James, Gal, Yoram, Colman, Fredric C., Aria, Behrad, Plante, Phillip John, Vreeke, Mark S., Friedman, Keith A., Tomasco, Michael F.
• Application Number:
  US10/722,246
• Publication Number:
  US 20040106858A1
• Time in Patent Office: Days
• US Class Current: 600/345
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/7445 Display arrangements, e.g. multiple display units
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: H01L 2224/45015 being circular
• CPC Class Codes: H01L 2224/45099 Material
• CPC Class Codes: H01L 2224/48091 Arched
• CPC Class Codes: H01L 2224/48247 connecting the wire to a bond pad of the item
• CPC Class Codes: H01L 23/3107 the device being completely enclosed
• CPC Class Codes: H01L 23/49548 Cross section geometry H01L23/49562 takes precedence
• CPC Class Codes: H01L 24/48 of an individual wire connector
• CPC Class Codes: H01L 2924/00 Indexing scheme for arrangements or methods for connecting or disconnecting semiconductor or solid-state bodies as covered by H01L24/00
• CPC Class Codes: H01L 2924/00014 the subject-matter covered by the group, the symbol of which is combined with the symbol of this group, being disclosed without further technical details
• CPC Class Codes: H01L 2924/01012 Magnesium [Mg]
• CPC Class Codes: H01L 2924/12042 LASER
• CPC Class Codes: H01L 2924/14 Integrated circuits
• CPC Class Codes: H01L 2924/181 Encapsulation
• CPC Class Codes: H01L 2924/19041 being a capacitor
• CPC Class Codes: H01L 2924/207 : Diameter ranges
• CPC Class Codes: H01L 2924/3011 : Impedance
• CPC Class Codes: Y02A 90/10 : Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

An analyte monitor includes a sensor, a sensor control unit, and a display unit. The sensor has, for example, a substrate, a recessed channel formed in the substrate, and conductive material disposed in the recessed channel to form a working electrode. The sensor control unit typically has a housing adapted for placement on skin and is adapted to receive a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and configured for coupling to two or more contact pads on the sensor. A transmitter is disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. The display unit has a receiver for receiving data transmitted by the transmitter of the sensor control unit and a display coupled to the receiver for displaying an indication of a level of an analyte. The analyte monitor may also be part of a drug delivery system to alter the level of the analyte based on the data obtained using the sensor.

Claims

1. An insertion kit for inserting an electrochemical sensor into a patient, the insertion kit comprising:

an inserter comprising a portion having a sharp, rigid, planer structure adapted to support the sensor during insertion of the electrochemical sensor; and

an insertion gun having a port configured to accept the electrochemical sensor and the inserter, a driving mechanism for driving the inserter and the electrochemical sensor into the patient, and a retraction mechanism for removing the inserter from the patient while leaving the sensor within the patient.

2. The insertion kit of claim 1, wherein the insertion gun further comprises a cocking mechanism to maintain the inserter and electrochemical sensor in a cocked position prior to insertion into the patient, and a release mechanism to release the inserter and electrochemical sensor from the cocked position and permit the driving mechanism to drive the inserter and electrochemical sensor into the patient.

3. The insertion kit of claim 1, further comprising an electrochemical sensor for insertion into the patient using the inserter and insertion gun.

4. The insertion kit of claim 3 wherein the electrochemical sensor includes a barb to facilitate retention of the sensor within the patient.

5. The insertion kit of claim 3 wherein the electrochemical sensor is flexible.

6. The insertion kit of claim 1, wherein the insertion gun and inserter are configured to insert the electrochemical sensor into the patient at a depth of between about 2 to 12 mm.

7. The insertion kit of claim 1, wherein the insertion gun and inserter are configured to insert the electrochemical sensor into the patient at an angle between about 15°

to 60°

relative to a surface of the patient.

8. The insertion kit of claim 1, wherein the inserter has a cross-sectional width of 1 mm or less.

9. The insertion kit of claim 1, wherein the inserter has a cross-sectional height of 1 mm or less.

10. The insertion kit of claim 1, wherein the inserter gun is configured to mate with a mounting base of a sensor control unit.