Analyte monitor

• US 20040202576A1
• Filed: 11/24/2003
• Published: 10/14/2004
• Est. Priority Date: 06/27/2000
• Status: Active Grant

• Current Assignee: Intuity Medical, Inc.
• Original Assignee: Rosedale Medical Inc. (Intuity Medical, Inc.)
• Inventors: Zanzucchi, Peter John, Aceti, John Gregory, Gregory, Christopher Carter, Moroney, Richard Morgan III, Loewy, Zvi Gerald
• Granted Patent: US 7,585,278 B2
• Time in Patent Office: Days
• US Class Current: 422/82.05
• 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

1-7. -7. (Canceled).

8. An analyte monitoring device having a housing, the device comprising:

one or more needles, each having a tip, a retracted position, a position whereinthe tip is extended from the housing a distance adapted to pierce the skin; and

a light source fixed to the housing aligned to heat tissue aligned to intercept the extended positions of the needles.

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

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

(b) making a second analyte concentration measurement in said host or portion thereof at a second point in said time period using a second substantially painless single use analyte concentration measurement means; and

(c) optionally making one or more additional analyte concentration measurements during said time period using one or more additional substantially painless 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 or portion thereof over said given time period.

10. The method according to claim 9, wherein said host or portion thereof is interstitial fluid.

11. The method according to claim 10, wherein said substantially painless single use analyte concentration measurement means is an interstitial fluid analyte measurement means.

12. The method according to claim 11, wherein said interstitial fluid analyte measurement means makes an in situ analyte concentration measurement.

13. The method according to claim 11, wherein said interstitial fluid analyte measurement means makes an ex vivo analyte concentration measurement.

14. The method according to claim 13, wherein said interstitial fluid analyte concentration measurement means removes interstitial fluid from said host and analyzes said fluid outside of said host.

15. The method according to claim 11, wherein said interstitial fluid analyte concentration measurement means comprises a microneedle.

16. The method according to claim 9, wherein said analyte is glucose.

17. The method according to claim 9, wherein the selected scheduling mode comprises a predetermined schedule.

18. The method according to claim 17, wherein the predetermined schedule comprises measurements taken at fixed time intervals.

19. The method according to claim 17, wherein the predetermined schedule comprises measurements taken at fixed times.

20. The method according to claim 9, wherein the selected scheduling mode comprises a scheduling mode responsive to previously collected analyte concentration measurements.

21. The method according to claim 20, wherein the previously collected analyte concentration measurements were taken over the previous 48 hours.

22. The method according to claim 20, wherein the previously collected analyte concentration measurements were taken over the previous two hours or less.

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

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

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

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

wherein said interstitial fluid glucose concentration measurements are made according to a predetermined schedule to monitor the concentration of interstitial fluid glucose over said given time period.

24. The method according to claim 23, wherein said interstitial fluid glucose measurement means makes an in situ measurement.

25. The method according to claim 24, wherein said interstitial fluid glucose measurement means makes an ex vivo measurement.

26. The method according to claim 25, wherein said interstitial fluid glucose concentration measurement means removes interstitial fluid from said host and analyzes said fluid outside of said host.

27. The method according to claim 23, wherein said interstitial fluid glucose concentration measurement means comprises a microneedle.

28. The method according to claim 23, wherein said method employs a device that comprises:

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

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

29. The method according to claim 28, wherein said activation means comprises hardware and software components that activate said first and second measurement means according to said predetermined schedule.

30. A device for using 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 substantially painless single use analyte concentration measurement means; and

(b) an activation means for selectively activating said first and second analyte concentration measurement means according to a predetermined schedule.

31. The device according to claim 30, wherein said activation means comprises hardware and software components that activate said first and second measurement means according to said predetermined schedule.

32. The device according to claim 30, wherein said substantially painless analyte concentration measurement means are interstitial fluid analyte concentration measurement means.

33. The device according to claim 32, wherein said interstitial fluid analyte concentration measurement means are glucose concentration measurement means.

34. The device according to claim 32, wherein said interstitial fluid analyte concentration measurement means comprise a microneedle.

35. The device according to claim 30, wherein said device comprises a removable cartridge that comprises said first and second analyte concentration measurement means.

36. 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 a second substantially painless single use analyte concentration measurement means; and

(b) a device into which said cartridge may be inserted, wherein said device comprises an activation means for selectively activating said first and second measurement means of said cartridge according to a predetermined schedule.

37. The system according to claim 36, wherein said activation means comprises hardware and software components that activate said first and second measurement means according to said predetermined schedule.

38. The system according to claim 36, wherein said substantially painless analyte concentration measurement means of said cartridge are interstitial fluid analyte concentration measurement means.

39. The system according to claim 38, wherein said interstital fluid analyte concentration measurement means are glucose concentration measurement means.

40. The system according to claim 39, wherein said interstitial fluid analyte concentration measurement means comprise a microneedle.

41. 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:

at least one of;

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

(b) a device into which said cartridge may be inserted, wherein said device comprises a an activation means for selectively activating said first and second measurement means of said cartridge according to a predetermined schedule.

42. The kit according to claim 41, wherein said activation means comprises hardware and software components that activate said first and second measurement means according to said predetermined schedule.

43. The kit according to claim 41, wherein said substantially painless analyte concentration measurement means of said cartridge are interstitial fluid analyte concentration measurement means.

44. The kit according to claim 43, wherein said interstitial fluid analyte concentration measurement means are glucose concentration measurement means.

45. The kit according to claim 43, wherein said interstitial fluid analyte concentration measurement means comprise a microneedle.

46. The kit according to claim 41, wherein said kit further comprises a second cartridge.

47. The kit according to claim 41, wherein said kit further comprises instructions for using said kit in monitoring the concentration of an analyte over a period of time.