Method and apparatus for storing an analyte sampling and measurement device

• US 20060184065A1
• Filed: 02/10/2006
• Published: 08/17/2006
• Est. Priority Date: 02/10/2005
• Status: Abandoned Application

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Boecker, Dirk, Deshmukh, Ajay, Mauze, Ganapati
• Application Number:
  US11/352,385
• Publication Number:
  US 20060184065A1
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150152 by an adequate mechanical impact on the puncturing location
• CPC Class Codes: A61B 5/150167 Adjustable piercing speed of skin piercing element, e.g. blade, needle, lancet or canula, for example with varying spring force or pneumatic drive
• CPC Class Codes: A61B 5/150175 Adjustment of penetration depth
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150427 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150503 Single-ended needles 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 5/15117 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 5/15151 Each piercing element being stocked in a separate isolated compartment
• CPC Class Codes: A61B 5/15161 Characterized by propelling the piercing element in a radial direction relative to the disc

Abstract

Methods and apparatus are provided for storing used and unused test strips in a desiccated environment. In one embodiment, the method comprises providing an analyte sampling device having a instrument housing and a cartridge having a plurality of penetrating members wherein the penetrating members are slidably movable to extend outward from lateral openings on the cartridge to penetrate tissue, where the sampling device include a plurality of analyte sensing members. The device is designed to use a cassette that will fit inside the device but also contain the cartridge in a desiccated environment. The user may open a lid or access door on the cassette to allow for lancing and sample capture. The lid is closed to re-establish a sealed condition inside the cassette once lancing is complete.

Claims

1. A fluid sampling device comprising:

an instrument housing;

a cartridge defining a plurality of cavities, the cartridge sized to fit within the instrument housing; and

a cassette for housing the cartridge, the cassette sized to fit within the housing;

a plurality of penetrating members at least partially contained in the cavities of the cartridge wherein the penetrating members are slidably movable to extend outward from the cartridge to penetrate tissue, the cavities each having a longitudinal opening providing access to an elongate portion of the penetrating member;

a sterility barrier coupled to the cartridge, the sterility barrier covering a plurality of the longitudinal openings, wherein the sterility barrier covering the lateral openings is configured to be moved so that the elongate portion may be accessed by the gripper without touching the barrier; and

desiccant material inside the device to reduce humidity therein.

2. The device of claim 1, wherein the desiccant material is inside the cassette.

3. The device of claim 1, wherein each of a cavity is individually sealed with the sterility barrier.

4. The device of claim 3, wherein each cavity is individually sealed to provide that opening of one cavity does not interfere with the sterility in an adjacent or other cavity in the cartridge

5. The device of claim 1, wherein the sterility barrier is a planar structure adhered to a top surface of the cartridge.

6. The device of claim 1, further comprising:

a plurality of analyte detecting members, each of an analyte detecting member coupled to a penetrating member.

7. The device of claim 6, wherein the desiccant is present in an amount of no more than 50 mm3 per each of an analyte detecting member.

8. The device of claim 6, wherein the desiccant is present in an amount of 10-20 mm3 per each of an analyte detecting member.

9. The device of claim 6, wherein the desiccant is present in an amount of 10-15 mm3 per each of an analyte detecting member.

10. The device of claim 6, wherein the desiccant is present in an amount of at least 1 mm3 per each of an analyte detecting member.

11. The device of claim 1, wherein the desiccant is selected from at least one of a molecular sieve, a silica gel or a clay.

12. The device of claim 11, wherein the molecular sieve is mixed with a polymeric binder.

13. The device of claim 7, further comprising

a scaffolding that supports the plurality of analyte detecting members.

14. The device of claim 13, wherein the scaffolding holds the desiccant.

15. The device of claim 14, wherein the scaffolding includes a desiccant for each of an analyte detecting member.

16. The device of claim 1, wherein the desiccant is present as a desiccant block inside of the instrument housing.

17. The device of claim 14, wherein the desiccant is molded and inserted into the scaffolding.

18. The device of claim 13, wherein the desiccant is coupled with the scaffolding.

19. The device of claim 13, wherein the desiccant and the scaffolding are co-molded simultaneously.

20. The device of claim 13, wherein the scaffolding and the desiccant are co-molded sequentially.

21. The device of claim 20. wherein the desiccant material is configured to be replaced when the cartridge is replaced from the instrument housing.

22. The device of claim 16, wherein the desiccant material is external to the analyte detecting members.

23. The device of claim 16, wherein the desiccant is on at least a portion of the analyte detecting members.

24. The device of claim 7, wherein each of an analyte detecting members are stored in an air tight desiccated environment.

25. The device of claim 7, wherein an air seal is formed around each of an analyte detecting member.

26. The device of claim 1, wherein an air tight seal is formed around the cartridge.

27. The device of claim 1, wherein an air tight seal is formed around the instrument housing.

28. The device of claim 1, wherein the instrument housing is in a sealed case.

29. The device of claim 1, further comprising:

a device that provides controlled velocity and depth of penetration of the penetrating members.

30. A device for use in penetrating tissue to obtain a body fluid sample, comprising:

an instrument housing;

a cartridge; and

a plurality of penetrating members slidably coupled to the cartridge, each of the penetrating members having a distal end sufficiently sharp to pierce tissue and each of the penetrating members being moveable relative to the other ones of the penetrating members, so that the distal end of the respective penetrating member is movable to penetrate tissue;

wherein each of the penetrating member is a bare lancet does not penetrate an outer sterility barrier during actuation;

a plurality of analyte sensing members mounted about the instrument housing;

a cassette to contain the cartridge and sized to fit within the instrument housing, the cassette providing a sealed environment when a lid on the cassette is closed to improve the storage condition of the analyte sensing members; and

desiccant in the device.

31. The device of claim 30, wherein the cassette contains desiccant.

32. The device of claim 30, wherein each of a cavity is individually sealed with the sterility barrier.

33. The device of claim 32, wherein each cavity is individually sealed to provide that opening of one cavity does not interfere with the sterility in an adjacent or other cavity in the cartridge

34. The device of claim 30, wherein the sterility barrier is a planar structure adhered to a top surface of the cartridge.

35. The device of claim 30, wherein each of an analyte detecting member is coupled to a penetrating member.

36. The device of claim 30, wherein the desiccant is present in an amount of no more than 50 mm3 per each of an analyte detecting member.

37. The device of claim 30, wherein the desiccant is present in an amount of 10-20 mm3 per each of an analyte detecting member.

38. The device of claim 30, wherein the desiccant is present in an amount of 10-15 mm3 per each of an analyte detecting member.

39. The device of claim 30, wherein the desiccant is present in an amount of at least 1 mm3 per each of an analyte detecting member.

40. The device of claim 30, wherein the desiccant is selected from at least one of a molecular sieve, a silica gel or a clay.

41. The device of claim 40, wherein the molecular sieve is mixed with a polymeric binder.

42. The device of claim 30, further comprising

a scaffolding that supports the plurality of analyte detecting members.

43. The device of claim 42, wherein the scaffolding holds the desiccant.

44. The device of claim 43, wherein the scaffolding includes a desiccant for each of an analyte detecting member.

45. The device of claim 30, wherein the desiccant is present as a desiccant block inside of the instrument instrument housing.

46. The device of claim 43, wherein the desiccant is molded and inserted into the scaffolding.

47. The device of claim 42, wherein the desiccant is coupled with the scaffolding.

48. The device of claim 42, wherein the desiccant and the scaffolding are co-molded simultaneously.

49. The device of claim 42, wherein the scaffolding and the desiccant are co-molded sequentially.

50. The device of claim 49, wherein the desiccant material is configured to be replaced when the cartridge is replaced from the instrument instrument housing.

51. The device of claim 47, wherein the desiccant material is external to the analyte detecting members.

52. The device of claim 47, wherein the desiccant is on at least a portion of the analyte detecting members.

53. The device of claim 30, wherein each of an analyte detecting members are stored in an air tight desiccated environment.

54. The device of claim 30, wherein an air seal is formed around each of an analyte detecting member.

55. The device of claim 30, wherein an air tight seal is formed around the cartridge.

56. The device of claim 30, wherein an air tight seal is formed around the instrument housing.

57. The device of claim 30, wherein the instrument instrument housing is in a sealed case.

58. The device of claim 30, further comprising:

a device that provides controlled velocity and depth of penetration of the penetrating members.

59. A method comprising:

providing an analyte sampling device having a instrument housing and a cartridge having a plurality of penetrating members wherein the penetrating members are slidably movable to extend outward from lateral openings on the cartridge to penetrate tissue;

providing the cartridge in a sealed cassette containing desiccant, wherein the cassette has a lid that is opened when the cartridge is about to be used.