Analyte monitor

• US 7,585,278 B2
• Filed: 11/24/2003
• Issued: 09/08/2009
• Est. Priority Date: 06/27/2000
• Status: Active Grant

• Current Assignee: Intuity Medical, Inc.
• Original Assignee: Intuity Medical, Inc.
• Inventors: Zanzucchi, Peter John, Aceti, John Gregory, Gregory, Christopher Carter, Lowey, Zvi Gerald, Moroney, Richard Morgan
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US10/722,074
• Publication Number:
  US 20040202576A1
• Time in Patent Office: 2,115 Days
• Field of Search: 600/309, 600/310, 600/316, 600/322, 600/345, 600/347, 600/573, 600/575, 600/583, 600/577, 600/556, 600/578, 600/584, 436/95, 422/68.1, 422/82.05, 422/82.06, 422/82.07, 422/82.08
• US Class Current: 600/309
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150473 Double-ended needles, e.g. used with pre-evacuated sampling tubes hollow piercing element tip design A61B5/150396; needle sets for catheters A61M25/06; needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150511 Details of construction of shaft
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15123 comprising magnets or solenoids
• CPC Class Codes: A61B 5/15146 Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means. multiple simultaneous cutting or piercing A61B5/150977
• CPC Class Codes: A61B 5/15153 Multiple piercing elements stocked in a single compartment
• CPC Class Codes: A61B 5/15163 Characterized by propelling the piercing element in an axial direction relative to the disc
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

Provided is an analyte monitoring device having a housing, the device comprising: a plurality of needles, each having a tip, a retracted position, a position wherein the tip is extended from the housing a distance adapted to pierce skin; an electrically or spring powered needle pushing apparatus movable to separately engage each of the needles to move each from the retracted position to the extended position; an energy source located within the housing; a plurality of analysis sites comprising an analysis preparation, each adapted to receive liquid from the needles to wet the analysis preparation; one or more light sources adapted to direct light at the analysis sites; one or more light detectors adapted to receive light from the analysis sites; and a processor.

Claims

1. A method of monitoring the concentration of an analyte in a host or portion thereof over a given time period using a monitoring device, said method comprising:

(a) making a first analyte concentration measurement in said host or portion thereof using a first single use analyte concentration measurement arrangement;

(b) making a second analyte concentration measurement in said host or portion thereof using a second single use analyte concentration measurement arrangement; and

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

wherein said analyte concentration measurements of (a) and (b) are automatically made according to a selected schedule contained in the monitoring device to monitor the concentration of said analyte in said host or portion thereof over said given time period.

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

3. The method according to claim 2, wherein said single use analyte concentration measurement arrangements are interstitial fluid analyte measurement arrangements.

4. The method according to claim 3, wherein said interstitial fluid analyte measurement arrangements make in situ analyte concentration measurements.

5. The method according to claim 3, wherein said interstitial fluid analyte measurement arrangements make ex vivo analyte concentration measurements.

6. The method according to claim 5, wherein said interstitial fluid analyte concentration measurement arrangements remove interstitial fluid from said host and analyze said fluid outside of said host.

7. The method according to claim 3, wherein said interstitial fluid analyte concentration measurement arrangements comprise a microneedle.

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

9. The method according to claim 1, wherein the selected schedule comprises a predetermined schedule.

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

11. The method according to claim 9, wherein the predetermined schedule comprises measurements taken at fixed times.

12. The method of claim 1, wherein the device comprising a controller that triggers (a) and (b) according to the selected schedule.

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

(a) making a first interstitial fluid glucose concentration measurement using a first single use interstitial fluid glucose concentration measurement arrangement;

(b) making a second interstitial fluid glucose concentration measurement using a second single use interstitial fluid glucose concentration measurement arrangement; and

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

wherein said interstitial fluid glucose concentration measurements (a) and (b) are automatically made according to a predetermined schedule contained in the device to monitor the concentration of interstitial fluid glucose over said given time period.

14. The method according to claim 13, wherein said interstitial fluid glucose measurement arrangements make in situ measurements.

15. The method according to claim 14, wherein said interstitial fluid glucose measurement arrangements make ex vivo measurements.

16. The method according to claim 15, wherein said interstitial fluid glucose concentration measurement arrangements remove interstitial fluid from said host and analyze said fluid outside of said host.

17. The method according to claim 13, wherein said interstitial fluid glucose concentration measurement arrangements comprise a microneedle.

18. The method of claim 13, wherein the device further comprises a controller that triggers (a) and (b) according to the predetermined schedule.

19. A monitoring device for use in monitoring the concentration of an analyte in a host or portion thereof over a given period of time, said device comprising:

(a) at least a first and a second single use analyte concentration measurement arrangements;

(b) a timing device; and

(c) an activation mechanism for automatically activating said first and second analyte concentration measurement arrangements according to a predetermined schedule contained in the monitoring device.

20. The device according to claim 19, wherein said analyte concentration measurement arrangements are interstitial fluid analyte concentration measurement arrangements.

21. The device according to claim 20, wherein said interstitial fluid analyte concentration measurement arrangements are glucose concentration measurement arrangements.

22. The device according to claim 20, wherein said interstitial fluid analyte concentration measurement arrangements each comprise a microneedle.

23. The device according to claim 19, wherein said monitoring device comprises a removable cartridge that comprises said first and second analyte concentration measurement arrangements.

24. A system for use in monitoring the concentration of an analyte in a host or portion thereof over a given period of time, said system comprising:

(a) a removable cartridge comprising at least a first and second single use analyte concentration measurement arrangements; and

(b) a monitoring device into which said cartridge may be inserted, wherein said monitoring device comprises a timing device and an activation mechanism for automatically activating said first and second measurement arrangements of said cartridge according to a predetermined schedule contained in the monitoring device.

25. The system according to claim 24, wherein said analyte concentration measurement arrangements of said cartridge are interstitial fluid analyte concentration measurement arrangements.

26. The system according to claim 25, wherein said interstitial fluid analyte concentration measurement arrangements are glucose concentration measurement arrangements.

27. The system according to claim 26, wherein said interstitial fluid analyte concentration measurement arrangements comprise a microneedle.

28. A kit for use in monitoring the concentration of an analyte in a host or portion thereof over a given period of time, said kit comprising:

(a) a removable cartridge comprising at least a first and a second single use analyte concentration measurement arrangements; and

(b) a device into which said cartridge may be inserted, wherein said device comprises a timing device; and

an activation mechanism for automatically activating said first and second measurement means of said cartridge according to a predetermined schedule contained in the device.

29. The kit according to claim 28, wherein said analyte concentration measurement arrangements of said cartridge are interstitial fluid analyte concentration measurement arrangements.

30. The kit according to claim 29, wherein said interstitial fluid analyte concentration measurement arrangements are glucose concentration measurement arrangements.

31. The kit according to claim 29, wherein said interstitial fluid analyte concentration measurement arrangements comprise a microneedle.

32. The kit according to claim 28, wherein said kit further comprises a second cartridge.

33. The kit according to claim 28, wherein said kit further comprises instructions for using said kit in monitoring the concentration of an analyte over a period of time.

34. A method of monitoring the concentration of an analyte in a host over a given time period using a monitoring device, said method comprising:

(a) making a first analyte concentration measurement using a first single use analyte concentration measurement arrangement;

(b) making a second analyte concentration measurement using a second single use analyte concentration measurement arrangement; and

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

wherein said analyte concentration measurements are made automatically according to a predetermined schedule selected from two or more predetermined schedules contained in the device and selected by the user or medical personnel to monitor the concentration of interstitial fluid glucose over said given time period.

35. The method according to claim 34, wherein said analyte measurement arrangements make in situ measurements.

36. The method according to claim 35, wherein said analyte measurement arrangements make ex vivo measurements.

37. The method according to claim 34, wherein the measurements are in part triggered according to a timetable programmed by the user or medical personnel.

38. The method according to claim 34, wherein said analyte concentration measurement arrangements comprise a microneedle.