Analyte monitoring device and methods of use

• US 8,473,021 B2
• Filed: 07/31/2009
• Issued: 06/25/2013
• Est. Priority Date: 04/30/1998
• Status: Expired due to Fees

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Say, James, Tomasco, Michael F., Heller, Adam, Gal, Yoram, Aria, Behrad, Heller, Ephraim, Plante, Phillip John, Vreeke, Mark S., Friedman, Keith A., Colman, Fredric C.
• Primary Examiner(s): Natnithithadha, Navin
• Application Number:
  US12/533,680
• Publication Number:
  US 20090292189A1
• Time in Patent Office: 1,425 Days
• Field of Search: 600/309, 600345-366
• US Class Current: 600/345
• CPC Class Codes: A61B 2560/0252 using ambient temperature
• 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 5/002 Monitoring the patient using a local or closed circuit, e.g. in a room or building A61B5/0017 takes precedence
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/1451 for interstitial fluid
• 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 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/72 Signal processing specially adapted for physiological signals or for diagnostic purposes character recognition, recognising digital ink, document-oriented image-based pattern recognition G06V30/00; recognition or understanding of postal images G06V30/424
• CPC Class Codes: A61B 5/7278 Artificial waveform generation or derivation, e.g. synthesising signals from measured signals A61B5/327 takes precedence
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61B 5/7405 using sound
• CPC Class Codes: A61B 5/743 Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots
• CPC Class Codes: A61B 5/7445 Display arrangements, e.g. multiple display units
• CPC Class Codes: A61B 5/7455 characterised by tactile indication, e.g. vibration or electrical stimulation
• CPC Class Codes: A61M 5/1723 : using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: C12Q 1/54 : involving glucose or galactose
• CPC Class Codes: G16H 10/40 : for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• 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 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 2924/0002 : Not covered by any one of groups H01L24/00, H01L24/00 and H01L2224/00
• CPC Class Codes: H01L 2924/19041 : being a capacitor
• CPC Class Codes: H01L 2924/3011 : Impedance
• CPC Class Codes: Y10S 128/903 : Radio telemetry
• CPC Class Codes: Y10T 29/49 : Method of mechanical manufacture
• CPC Class Codes: Y10T 29/49124 : On flat or curved insulated base, e.g., printed circuit, etc.

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 analyte sensing assembly, comprising:

a mounting unit configured to adhere to a skin surface;

a housing unit; and

an analyte sensor configured to couple to the housing unit, the analyte sensor including at least one electrode;

wherein the analyte sensor includes a proximal portion configured to connect with the housing unit and a distal portion that includes a portion of the at least one electrode configured to be subcutaneously positioned beneath the skin surface, wherein the portion of the at least one electrode that is configured to be subcutaneously positioned is covered with an analyte mass transport limiting layer, and wherein the analyte sensor is configured to advance through the mounting unit after the mounting unit is adhered to the skin surface, the analyte sensor is further configured to connect with the housing unit after the distal portion of the analyte sensor is positioned beneath the skin surface, and a conductive contact of the analyte sensor is configured to couple with at least one conductive contact disposed on the housing unit.

2. The assembly of claim 1 further comprising at least one other electrode that is not subcutaneously positionable.

3. The assembly of claim 2 wherein the at least one electrode is a working electrode.

4. The assembly of claim 3 wherein the at least one electrode includes at least two electrodes, and wherein the at least two electrodes are working electrodes.

5. The assembly of claim 1 wherein the at least one electrode is a working electrode.

6. The assembly of claim 5 wherein the at least one electrode includes at least two electrodes, and wherein the at least two electrodes includes a working electrode and a reference electrode.

7. The assembly of claim 1 further comprising at least one other electrode that is configured to be positioned on the skin surface.

8. The assembly of claim 7 wherein the at least one other electrode that is configured to be positioned on the skin surface is a reference electrode, a counter electrode or a counter/reference electrode.

9. The assembly of claim 1 further comprising a temperature probe.

10. The assembly of claim 1 wherein the analyte sensor has a distal portion configured to be implanted and a proximal portion configured to be nonimplanted.

11. The assembly of claim 1 wherein the at least one electrode is configured for sensing glucose.

12. The assembly of claim 1 wherein the at least one electrode is configured for sensing an analyte in interstitial fluid or blood.

13. The assembly of claim 1 further including a transmitter unit configured to establish electrical contact with the at least one electrode.

14. The assembly of claim 1 wherein the analyte mass transport limiting layer is covered with a biocompatible layer.

15. The assembly of claim 1 wherein the portion of the at least one electrode that is configured to be subcutaneously positioned is covered with an interferent-eliminating layer.

16. The assembly of claim 1 wherein the distal portion of the analyte sensor is bent at an angle relative to the proximal portion.

17. The assembly of claim 16 wherein the angle is about 90 degrees.

18. The assembly of claim 1 wherein the analyte sensor is flexible.

19. The assembly of claim 1 wherein the distal portion is narrower than the proximal portion, the proximal portion further comprising the conductive contact, wherein the conductive contact corresponds to the at least one electrode.

20. The assembly of claim 19 wherein the distal portion has a width less than 2 mm and the proximal portion has a width from 3 mm to 7 mm.

21. The assembly of claim 19 wherein the distal portion has a width less than 0.5 mm and the proximal portion has a width from 1 mm to 10 mm.

22. The assembly of claim 1 wherein the analyte mass transport limiting layer limits the flow of oxygen to the covered at least one electrode.

23. The assembly of claim 1 wherein the at least one conductive contact disposed on the housing unit and the conductive contact of the analyte sensor are configured to couple when the housing unit is mounted to the mounting unit.

24. The assembly of claim 1 wherein the analyte sensor is disposed in a sharp, rigid insertion member of an inserter, the analyte sensor being configured to release from the inserter after being positioned beneath the skin surface.

25. The assembly of claim 1 wherein the analyte sensor is configured to be positioned beneath the skin surface by providing a force against the inserter to advance the sensor beneath the skin surface.

26. An analyte sensing assembly, comprising:

a mounting unit configured to adhere to a skin surface;

a housing unit; and

an analyte sensor including at least one electrode wherein a distal portion of the analyte sensor includes a portion of the at least one electrode is configured to be implanted beneath the skin surface, wherein the portion of the at least one electrode that is configured to be implanted beneath the skin surface is covered with an analyte mass transport limiting layer;

wherein the analyte sensor includes a proximal portion configured to connect with the housing unit, and wherein the analyte sensor is configured to advance through the mounting unit after the mounting unit is adhered to the skin surface, the analyte sensor is further configured to connect with the housing unit after the distal portion of the analyte sensor is positioned beneath the skin surface, and a conductive contact of the analyte sensor is configured to couple with at least one conductive contact disposed on the housing unit.

27. The assembly of claim 26 wherein the at least one electrode is a working electrode.

28. The assembly of claim 26 further comprising a plurality of electrodes wherein at least one of the plurality of electrodes is a working electrode.

29. The assembly of claim 28 wherein each of the plurality of electrodes is a working electrode.

30. The assembly of claim 26 further comprising a temperature probe.

31. The assembly of claim 26 wherein the analyte sensor is configured for sensing a glucose level.

32. The assembly of claim 26 wherein the analyte sensor is configured for sensing an analyte level in interstitial fluid or blood.

33. The assembly of claim 26 further including a transmitter unit disposed in the housing unit and configured to establish electrical contact with the at least one electrode.

34. The assembly of claim 26 wherein the at least one conductive contact disposed on the housing unit and the conductive contact of the analyte sensor are configured to couple when the housing unit is mounted to the mounting unit.

35. The assembly of claim 26 wherein the analyte sensor is disposed in a sharp, rigid insertion member of an inserter, and the analyte sensor is configured to release from the inserter after being positioned beneath the skin surface.

36. The assembly of claim 26 wherein the analyte sensor is configured to be positioned beneath the skin surface by providing a force against the inserter to advance the sensor beneath the skin surface.