Analyte monitoring device and methods of use

Patent metadata

Field	Value
Publication number	US-9326714-B2
Application number	US-82569210-A
Country	US
Kind code	B2
Filing date	Jun 29, 2010
Priority date	Apr 30, 1998
Publication date	May 3, 2016
Grant date	May 3, 2016

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.

First claim

We claim:

1. An analyte sensor unit comprising:
a housing adapted for placement on the surface of skin having a bottom surface for contacting with the skin and wherein the housing comprises:
an electrochemical sensor comprising a plurality of electrodes including a working electrode, wherein the sensor comprises a portion within the housing and a portion exterior to the housing to permit insertion of the electrochemical sensor to a depth of about 2 to about 7 mm beneath the surface of the skin, wherein the electrochemical sensor comprises a substrate comprising all of the plurality of electrodes;
sensor electronics comprising an RF communication unit for communicating data obtained by the electrochemical sensor, the sensor electronics coupled to the electrochemical sensor through the electrical contacts, wherein the sensor electronics comprise electrical contacts that are positioned between at least a portion of the electrochemical sensor and the bottom surface of the housing; and
a readable or readable/writable memory for storing factory determined calibration information for calibrating the electrochemical sensor, wherein the electrochemical sensor does not require user-implemented calibration following insertion of a portion of the sensor beneath the surface of the skin; and

an adhesive disposed on the bottom surface of the housing to attach the housing to the surface of the skin.

2. The analyte sensor unit of claim 1 , wherein the electrochemical sensor is inserted beneath the surface of the skin at a position located substantially beneath the housing when the housing is placed on the skin.

3. The analyte sensor unit of claim 1 , wherein the electrochemical sensor has a length of about 0.3 to about 5 cm and comprises a proximal end that is in contact with electrical contacts within the housing and a distal end that extends through an opening at the bottom of the housing.

4. The analyte sensor unit of claim 3 , wherein at least a portion of the distal end of the electrochemical sensor is bent so that a portion of the sensor is in a plane substantially perpendicular to the electrical contacts in the housing.

5. The analyte sensor unit of claim 3 , wherein the distal end of the electrochemical sensor has a length of up to about 6 mm.

6. The analyte sensor unit of claim 3 , wherein the electrochemical sensor has a length of up to about 2 cm.

7. The analyte sensor unit of claim 1 , wherein the housing comprises a data storage unit to store analyte data obtained by the electrochemical sensor.

8. The analyte sensor unit of claim 1 , wherein the analyte sensor unit automatically detects use following insertion by transitioning from a sleep mode to an active mode.

9. The analyte sensor unit of claim 8 , wherein automatically detecting use comprises detecting a change in resistance in the electrochemical sensor.

10. The analyte sensor unit of claim 9 , wherein automatically detecting use further comprises activating the analyte sensor unit.

11. The analyte sensor unit of claim 1 , wherein the RF communication unit receives data from a second RF communication unit of a display unit.

12. The analyte sensor unit of claim 11 , wherein data received by the RF communication unit comprises an activation signal.

13. The analyte sensor unit of claim 12 , wherein the electrical contacts are disposed on an interior surface of the housing.

14. The analyte sensor unit of claim 1 , further comprising a processor to determine the rate of change of the glucose.

15. The analyte sensor unit of claim 1 , further comprising a processing circuit disposed in the housing for determining a level of an analyte from a signal generated by the electrochemical sensor.

16. The analyte sensor unit of claim 15 , wherein the processing circuit adjusts the data for temperature using a signal from a temperature probe of the sensor.

17. The analyte sensor unit of claim 1 , wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer by one or more covalent bonds to the polymer.

18. The analyte sensor unit of claim 17 , wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer by one or more carbon-carbon, carbon-nitrogen, or metal-carbon covalent bonds to the polymer.

19. The analyte sensor unit of claim 18 , wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer through one or more crosslinking agents.

20. The analyte sensor unit of claim 19 , wherein the crosslinking agent is one or more of substituted or unsubstituted epoxides, aldehydes, imidoesters, N-hydroxysuccinimide esters, carbodiimides, cyanuric chloride, tetrachlorobenzoquinone, benzoquinone and tetracyanoquinodimethane.

21. The analyte sensor unit of claim 17 , wherein the mediator is crosslinked with the polymer by at least one covalent bond to one or more ligands of the mediator.

22. The analyte sensor unit of claim 21 , wherein the one or more ligands comprises a substituted or unsubstituted heterocyclic nitrogen-containing moiety.

23. The analyte sensor unit of claim 17 , wherein one or more ligands of the mediator are crosslinkers of the polymer.

24. The analyte sensor unit of claim 17 , wherein one or more ligands of the mediator are substituents of the polymer backbone.

25. The analyte sensor unit of claim 17 , wherein the analyte-responsive enzyme is crosslinked with the polymer by at least one covalent bond to one or more side chains of the enzyme.

26. The analyte sensor unit of claim 25 , wherein the one or more side chains of the analyte-responsive enzyme is selected from the group consisting of substituted or unsubstituted amines, alcohols, thiols, phenols, imidazoles, indols, and carboxylic acids.

27. The analyte sensor unit of claim 25 , wherein the one or more side chains of the analyte-responsive enzyme are crosslinkers of the polymer.

28. The analyte sensor unit of claim 25 , wherein the one or more side chains of the analyte-responsive enzyme are substituents of the polymer backbone.

29. The analyte sensor unit of claim 1 , wherein the polymer forms a coordination complex with the mediator.

30. The analyte sensor unit of claim 29 , wherein one or more nitrogen-containing moieties of the polymer forms a coordination complex with a metal of the mediator.

31. The analyte sensor unit of claim 1 , wherein the mediator is crosslinked with the polymer by one or more ionic bonds to the mediator.

32. The analyte sensor unit of claim 31 , wherein the polymer comprises at least one positively charged moiety and the mediator comprises at least one negatively charged moiety.

33. The analyte sensor unit of claim 31 , wherein the polymer comprises at least one negatively charged moiety and the mediator comprises at least one positively charged moiety.

34. The analyte sensor unit of claim 1 , wherein the polymer is chemically bonded to the surface of the working electrode.

35. The analyte sensor unit of claim 1 , wherein the sensing layer membrane is formed in situ on the working electrode.

36. The analyte sensor unit of claim 35 , wherein the sensing layer membrane is formed in situ on the working electrode by crosslinking the polymer on the wor

Assignees

• 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
• Abbott Diabetes Care Inc

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

Classifications

• A61B5/1486

  using enzyme electrodes, e.g. with immobilised oxidase · CPC title

• Y10T29/49

  Method of mechanical manufacture · CPC title

• A61B5/743

  Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots · CPC title

• A61B5/1473

  invasive, e.g. introduced into the body by a catheter · CPC title

• C12Q1/54

  involving glucose or galactose · CPC title