Monitoring analyte concentration using minimally invasive devices

• US 6,549,796 B2
• Filed: 05/25/2001
• Issued: 04/15/2003
• Est. Priority Date: 05/25/2001
• Status: Expired due to Term

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Sohrab, Borzu
• Primary Examiner(s): DOUGLAS, LISA ANN
• Application Number:
  US09/865,826
• Publication Number:
  US 20020177764A1
• Time in Patent Office: 690 Days
• Field of Search: 600/345, 600/347, 600/575, 600/583, 600/584, 606/181
• 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 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/681 Wristwatch-type devices
• CPC Class Codes: G01N 33/50 Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing measuring or testing processes involving enzymes or microorganisms, compositions or test papers therefor; processes for forming such compositions, condition responsive control in microbiological or enzymological processes C12Q
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose

Abstract

A method of monitoring the concentration of an analyte in a host or portion thereof over a given period of time. The method includes the steps of: (a) making a first analyte concentration measurement at a first point of time using a single use analyte concentration measuring device; (b) making a second analyte concentration measurement at a second point in time using a single use analyte concentration measuring device; and (c) making one or more additional analyte concentration measurements using another single use measuring device, wherein the analyte concentration measurements are made according to a selected schedule to monitor the concentration of analyte in a host over a given portion of time.

Claims

1. A method of monitoring the concentration of analyte in a host over a given time period, said method comprising:

(a) making a first analyte concentration measurement in said host at a first point in said time period using a first single use analyte concentration measurement means;

(b) making a second analyte concentration measurement in said host at a second point in said time period using a second single use analyte concentration measurement means,

wherein said analyte concentration measurements are made according to a selected scheduling mode to monitor the concentration of said analyte in said host over said given time period; and

(c) making one or more additional analyte concentration measurements during said time period using one or more additional single use analyte concentration measurement means;

wherein said time period of said additional measurements is based on results of said first and second measurements.

2. The method according to claim 1, wherein said host is interstitial fluid.

3. The method according to claim 2, wherein said single use analyte concentration measurement means is an interstitial fluid analyte measurement means.

4. The method according to claim 3, wherein said interstitial fluid analyte measurement means makes an in situ analyte concentration measurement.

5. The method according to claim 3, wherein said interstitial fluid analyte concentration measurement means removes interstitial fluid from said host and analyzes said fluid outside of said host.

6. The method according to claim 3, wherein said interstitial fluid analyte concentration measurement means comprises a microneedle.

7. The method according to claim 1, wherein said analyte is glucose.

8. The method according to claim 1, wherein the selected scheduling mode comprises a predetermined schedule.

9. The method according to claim 8, wherein the predetermined schedule comprises measurements taken at fixed time intervals.

10. The method according to claim 8, wherein the predetermined schedule comprises measurements taken at fixed times.

11. The method according to claim 1, wherein the selected scheduling mode comprises a scheduling mode responsive to previously collected analyte concentration measurements.

12. The method according to claim 11, wherein the previously collected analyte concentration measurements were taken over the previous 48 hours.

13. The method according to claim 11, wherein the previously collected analyte concentration measurements were taken over the previous two hours or less.

14. A method of monitoring the concentration of glucose in interstitial fluid of a host over a given period of time, said method comprising:

(a) making a first interstitial fluid glucose concentration measurement at a first point in said time period using a first single use fluid glucose concentration measurement means;

(b) making a second interstitial fluid glucose concentration measurement at a second point in said time period using a second single use fluid glucose concentration measurement means;

wherein said analyte concentration measurements are made according to a selected scheduling mode to monitor the concentration of said analyte in said host over said given time period; and

(c) making one or more additional analyte concentration measurements during said time period using one or more additional single use interstitial fluid glucose concentration measurement means;

wherein said time period of said additional measurements is based on results of said first and second measurements.

15. The method according to claim 14, wherein said interstitial fluid glucose measurement means makes an in situ measurement.

16. The method according to claim 15, wherein said interstitial fluid analyte concentration measurement means removes interstitial fluid from said host and analyzes said fluid outside of said host.

17. The method according to claim 14, wherein said interstitial fluid glucose concentration measurement means comprises a microneedle.

18. The method according to claim 14, wherein said method employs a device that comprises:

(a) at least said first and second interstitial fluid glucose measurement means; and

(b) an activation means that activates said first and second measurement means according to a predetermined schedule.

19. The method according to claim 18, wherein said activation means comprises hardware and software components that activate said first and second measurement means according to said predetermined schedule.