Devices and methods for frequent measurement of an analyte present in a biological system

• US 6,561,978 B1
• Filed: 02/11/2000
• Issued: 05/13/2003
• Est. Priority Date: 02/12/1999
• Status: Expired due to Term

• Current Assignee: LifeScan IP Holdings, LLC
• Original Assignee: Cygnus, Inc. (Johnson & Johnson)
• Inventors: Tamada, Janet A., Soni, Pravin L., Ford, Russell, Conn, Thomas E., Potts, Russell O., Tierney, Michael J.
• Primary Examiner(s): Winakur, Eric F.
• Assistant Examiner(s): KREMER, MATTHEW J
• Application Number:
  US09/503,227
• Time in Patent Office: 1,187 Days
• Field of Search: 600/345-347, 600/354-365, 600/310, 600/309, 600/322-326, 600/316, 128/903-904, 604/93.01
• US Class Current: 600/309
• 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 5/0031 Implanted circuitry
• 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 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/681 Wristwatch-type devices
• CPC Class Codes: A61B 5/6831 Straps, bands or harnesses

Abstract

Devices and methods are provided for frequently measuring the concentration of an analyte present in a biological system. A monitoring system having at least two components is employed in order to allow separation of data collection from data processing and display. Such separation allows greater flexibility and convenience for the user.

Claims

1. A monitoring system for frequently measuring glucose present in a subject and providing to said subject self-monitoring of said glucose, said monitoring system comprising,

(A) a first component to be placed in contact with a skin or mucosal surface of said subject comprising

(i) an iontophoretic sampling mechanism for extracting the glucose from the subject, wherein said sampling mechanism is adapted for extracting the glucose across the skin or mucosal surface of said-subject;

(ii) a sensing mechanism in operative contact with the glucose extracted by the sampling mechanism, wherein said sensing mechanism obtains a signal from the extracted glucose by detecting electrochemical signals produced at a biosensor electrode surface and said signal is specifically related to the glucose amount or concentration; and

(iii) a first mechanism for providing operative communication with a second component of the monitoring system, wherein said operative communication comprises wireless communication technology that employs electromagnetic waves;

wherein said first and second components are separately housed; and

(B) the second component, comprising

(i) a user interface;

(ii) a second mechanism for providing operative communication with the first component, wherein said operative communication comprises wireless communication technology that employs electromagnetic waves, the second component (a) receives the signal from the first component, and (b) is capable of communicating with a third component remote from the subject being monitored, and

(iii) a computing mechanism that converts the signal from the extracted glucose to an output indicative of the amount or concentration of glucose extracted by the sampling mechanism, wherein the second component displays said output and provides an alarm to the subject when the amount or concentration of glucose is above or below threshold values;

wherein said second component is adapted to be carried by the subject.

2. The monitoring system of claim 1, wherein the wireless communication technology employs low frequency electromagnetic waves in a frequency range of about 1 Hz. to about 1 Mega Hz.

3. The monitoring system of claim 1, wherein the wireless communication technology employs medium frequency electromagnetic waves in a frequency range of about 1 Mega Hz. to about 500 Mega Hz.

4. The monitoring system of claim 1, wherein the wireless communication technology employs high frequency electromagnetic waves in a frequency range of about 500 Mega Hz. to about 5 Giga Hz.

5. The monitoring system of claim 1, wherein the second component relays command signals to the first component.

6. The monitoring system of claim 5, wherein the command signals include signals to control operation of the sensing mechanism.

7. The monitoring system of claim 5, wherein the command signals include signals to control operation of the sampling mechanism.

8. The monitoring system of claim 1, wherein the second component can store glucose-related data.

9. The monitoring system claim 1, wherein said subject is a mammal.

10. The monitoring system of claim 9, wherein said mammal is a human.

11. The monitoring system of claim 1, further comprising

(C) a delivery device component comprising

(i) a delivery device; and

(ii) a third mechanism for providing operative communication with the first and second components, wherein the communication between first and second components and the third component is wireless.

12. The monitoring system of claim 11, wherein the delivery device is implanted in the subject.

13. The monitoring system of claim 11, wherein the delivery device is external to the subject.

14. The monitoring system of claim 11, wherein the delivery device comprises an insulin pump.

15. The monitoring system of claim 1, further comprising

(C) the third component comprising

(i) a modem or personal computer;

and

(ii) a third mechanism for providing operative communication with the first and second components, wherein said operative communication comprises wireless communication technology that employs electromagnetic waves.

16. The monitoring system of claim 15, wherein the modem or personal computer is operably linked to a wide area network (WAN).