Analyte monitoring device alarm augmentation system

• US 6,553,244 B2
• Filed: 08/10/2001
• Issued: 04/22/2003
• Est. Priority Date: 08/18/2000
• Status: Active Grant

• Current Assignee: LifeScan IP Holdings, LLC
• Original Assignee: Cygnus, Inc. (Johnson & Johnson)
• Inventors: Lesho, Matthew J., Morley, Samuel A. Jr.
• Primary Examiner(s): Hindenburg, Max F.
• Assistant Examiner(s): MALLARI, PATRICIA C
• Application Number:
  US09/927,575
• Publication Number:
  US 20020065453A1
• Time in Patent Office: 620 Days
• Field of Search: 600/300-301, 600/345-347, 600/365
• US Class Current: 600/347
• 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 5/1486 using enzyme electrodes, e.g. with immobilised oxidase

Abstract

The present invention relates to a device for augmenting an alarm signal generated by an analyte monitoring device, e.g., the GlucoWatch® (Cygnus, Inc., Redwood City, Calif.) biographer glucose monitoring device, for improving the alarm signal'"'"'s effectiveness in alerting the user, and/or for communicating the signal to a person or person(s) other than the user, or to a trained assistance animal.

Claims

1. An improved glucose monitoring device, comprising

a durable element comprising (A) a housing to which a consumable element can be operably connected, (B) circuitry, (C) a display element, (D) one or more microprocessor elements, (B) electrical connector elements, and (F) means to provide an audible alert when glucose levels in a subject being monitored are outside of a predetermined range, wherein (a) said consumable element comprises a mask layer, a collection insert layer comprising two hydrogels, a gel retaining layer, an electrode assembly comprising two iontophoretic electrodes and two sensing electrodes, and a support tray, and (b) the improvement comprises modification of the circuitry of the durable element of said device to provide an augmented alarm signal capable of alerting a user of said device to glucose levels outside of a predetermined range, said alarm signal selected from the group consisting of (i) tactile stimulus, (ii) auditory stimulus, (iii) visual stimulus, and (iv) variations and combinations thereof.

2. The improved glucose monitoring device of claim 1, wherein said device comprises iontophoretic channels, and said iontophoretic channels are modified to be capable of delivering an electrical current to provide a tactile stimulus.

3. The improved glucose monitoring device of claim 1, further comprising said durable element operably linked to the consumable element.

4. An improved glucose monitoring device, comprising

a durable element comprising (A) a housing to which a consumable element can be operably connected, (B) circuitry, (C) a display element, (D) one or more microprocessor elements, (E) electrical connector elements, and (F) means to provide an audible alert when glucose levels in a subject being monitored are outside of a predetermined range, wherein (a) said consumable element comprises a mask layer, a collection insert layer comprising two hydrogels, a gel retaining layer, an electrode assembly comprising two iontophoretic electrodes and two sensing electrodes, and a support tray, and (b) the improvement comprises modification of the circuitry of the durable element of said device to provide a connection to a first signaling component for producing alarm signals capable of alerting a user of said device to glucose levels outside of the predetermined range.

5. The improved glucose monitoring device of claim 4, wherein said first signaling component is selected from the group consisting of (i) an auditory stimulus generator;

(ii) a visual stimulus generator;

(iii) a tactile stimulus generator;

(iv) an olfactory stimulus generator; and

(v) variations and combinations thereof.

6. The improved glucose monitoring device of claim 4, wherein the connection is via a telemetering system, wherein said telemetering system is selected from the group consisting of (i) electromagnetic radiation;

(ii) capacitance coupling;

(iii) inductive coupling (iv) infrared coupling; and

(v) variations and combinations thereof.

7. The improved glucose monitoring device of claim 4, wherein the connection is via a wire-like connector.

8. The improved glucose monitoring device of claim 4, further comprising said durable element operably linked to said consumable element.

9. The improved glucose monitoring device of claim 4, wherein said modification comprises adding a serial port to said glucose monitoring device, said port being in operative communication with said glucose monitoring device and providing said connection.

10. The improved glucose monitoring device of claim 4, wherein said glucose monitoring device comprises transmission and receipt lines, and said modification comprises modifying the transmission and receipt lines of said glucose monitoring device to provide said connection.

11. An alarm augmentation system for an analyte monitoring device, comprising

an analyte monitoring device, said analyte monitoring device comprising

an acquisition unit comprising, a durable element comprising (A) a housing to which a consumable element can be operably connected, (B) circuitry, (C) one or more microprocessor elements, and (D) electrical connector elements, wherein (a) said consumable element comprises a mask layer, a collection insert layer comprising two hydrogels, a gel retaining layer, an electrode assembly comprising two iontophoretic electrodes and two sensing electrodes, and a support tray;

and

a display unit, operably linked to said acquisition unit, wherein (i) said display unit comprises means to provide an audible alert when an analyte level, in a subject being monitored, is outside of a predetermined range, and (ii) said acquisition unit and said display units are separately housed; and

an alarm augmentation system comprising a first signaling component, capable of producing alarm signals to alert a subject in response to analyte levels outside of a predetermined range, said first signaling component operably linked to said display unit.

12. The alarm augmentation system of claim 11, further comprising a transmitter component, operably linked to said display unit, said transmitter component capable of transmitting alarm signals to at least one external communication target.

13. The alarm augmentation system of claim 12, wherein said transmitter further provides an operative link between said display unit and said first signaling component.

14. The alarm augmentation system of claim 12, wherein said transmitter component comprises a serial port and a wire-like connector, said port and said connector capable of connecting with at least one external communication target.

15. The alarm augmentation system of claim 12, wherein said transmitter component comprises a telemetering system selected from the group consisting of (i) electromagnetic radiation;

(ii) capacitance coupling;

(iii) inductive coupling;

(iv) infrared coupling; and

(v) combinations and variations thereof.

16. The alarm augmentation system of claim 15, wherein said telemetering system is capable of connecting with said first signaling component and said external communication target.

17. The alarm augmentation system of claim 15, wherein (a) said external communication target is a second signaling component, capable of producing alarm signals to alert a person or persons other than the user of said analyte monitoring device to analyte levels outside of the predetermined range, (b) said second signaling component is selected from the group consisting of (i) an auditory stimulus generator;

(ii) a visual stimulus generator;

(iii) a tactile stimulus generator;

(iv) an olfactory stimulus generator;

(v) a gustatory stimulus generator; and

(vi) variations and combinations thereof, and (c) said second signaling component is operably linked to said transmitter component via said telemetering system.

18. The alarm augmentation system of claim 17, further comprising

a processor component, wherein said processor component is (i) operably linked to said display unit, said acquisition unit, said transmitter component, and said first and second signaling components, (ii) capable of receiving and processing information received from said display unit, said acquisition unit, and said first and second signaling components, and (iii) capable of controlling the operation of said transmitter component and said first and second signaling components.

19. The alarm augmentation system of claim 11, wherein said first signaling component comprises an auditory stimulus generator, and said auditory stimulus generator provides a volume control for varying the volume of auditory stimuli generated thereby.

20. The alarm augmentation system of claim 11, wherein said first signaling component is selected from the group consisting of (i) an auditory stimulus generator;

(ii) a visual stimulus generator;

(iii) a tactile stimulus generator;

(iv) an olfactory stimulus generator;

(v) a gustatory stimulus generator; and

(vi) variations and combinations thereof.