Method and apparatus for storing an analyte sampling and measurement device

• US 20060167382A1
• Filed: 12/29/2005
• Published: 07/27/2006
• Est. Priority Date: 12/30/2004
• Status: Abandoned Application

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Deshmukh, Ajay
• Application Number:
  US11/324,001
• Publication Number:
  US 20060167382A1
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• 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 5/15123 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
• CPC Class Codes: A61B 5/15182 Means for keeping track or checking of the total number of piercing elements already used or the number of piercing elements still remaining in the stocking, e.g. by check window, counter, display
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

Methods and apparatus are provided for storing an analyte sampling and measurement device. In one embodiment, an analyte sampling device has a housing and a cartridge having a plurality of penetrating members wherein the penetrating members are slidably movable to extend outward from lateral openings on said cartridge to penetrate tissue, where the sampling device include a plurality of analyte detecting members. The device is fitted with a plurality of gaskets to provide a sealed environment inside the sampling device when the device is not in use. The user can open a lid to allow for lancing and sample capture. The lid is closed to re-establish a sealed condition inside the device once lancing is complete.

Claims

1. A fluid sampling device comprising:

an instrument housing;

a plurality of penetrating members in the instrument housing;

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

a desiccant material inside the instrument housing and positioned external to the plurality of penetrating members, the desiccant material reducing humidity.

2. The device of claim 1, further comprising:

a sterility barrier configured to provide sterile environments for the plurality of penetrating members.

3. The device of claim 1, wherein the desiccant is present in an amount of no more than 50 mm³ per each of an analyte detecting member.

4. The device of claim 1, wherein the desiccant is present in an amount of 10-20 mm³ per each of an analyte detecting member.

5. The device of claim 1, wherein the desiccant is present in an amount of 10-15 mm³ per each of an analyte detecting member.

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

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

8. The device of claim 7, wherein the molecular sieve is mixed with a polymeric binder.

9. The device of claim 1, further comprising

a scaffolding that supports the plurality of analyte detecting members.

10. The device of claim 9, wherein the scaffolding holds the desiccant.

11. The device of claim 10, wherein the scaffolding includes a desiccant for each of an analyte detecting member.

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

13. The device of claim 10, wherein the desiccant is molded and inserted into the scaffolding.

14. The device of claim 1, wherein the desiccant is coupled with the scaffolding.

15. The device of claim 1, wherein the desiccant and the scaffolding are co-molded simultaneously.

16. The device of claim 1, wherein the scaffolding and the desiccant are co-molded sequentially.

17. The device of claim 1, wherein the plurality of analyte detecting members and the plurality of penetrating members form a disposable device.

18. The device of claim 17, wherein the desiccant material is configured to be replaced when the disposable device is replaced from the instrument housing.

19. The device of claim 14, wherein the desiccant material is external to the analyte detecting members.

20. The device of claim 14, wherein the desiccant is on at least a portion of the analyte detecting members.

21. The device of claim 17, wherein the disposable device includes a plurality of cavities.

22. The device of claim 17, further comprising:

a cassette for housing the disposable device and sized to fit within the instrument housing.

23. The device of claim 22, wherein the plurality of penetrating members are at least partially contained in the cavities of the disposable device, wherein the penetrating members are slidably movable to extend outward from the disposable device to penetrate tissue, the cavities each having a longitudinal opening providing access to an elongate portion of the penetrating member.

24. The device of claim 23, wherein a sterility barrier covers a plurality of the longitudinal openings, wherein the sterility barrier is configured to be moved so that the elongate portion can be accessed by a gripper without touching the sterility barrier.

25. The device of claim 24, further comprising:

at least one gasket on the instrument housing to create a sealed air-tight environment inside the instrument housing.

26. The device of claim 14, wherein each of an analyte detecting members are stored in an air tight desiccated environment.

27. The device of claim 14, wherein an air seal is formed around each of an analyte detecting member.

28. The device of claim 17, wherein an air tight seal is formed around the disposable device.

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

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

31. The device of claim 1 further comprising:

a case sized to contain the instrument housing, the case containing the desiccant and providing a sealed environment when closed.

32. The device of claim 1, further comprising:

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

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

50. The device of claim 43, wherein the desiccant material is external to the analyte detecting members.

51. The device of claim 43, wherein the desiccant is on at least a portion of the analyte detecting members.

57. The device of claim 43, wherein each of an analyte detecting members are stored in an air tight desiccated environment.

58. The device of claim 43, wherein an air seal is formed around each of an analyte detecting member.

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

a instrument housing;

a plurality of penetrating members;

a plurality of analyte detecting members, each of an analyte detecting member being associated with a penetrating member; and

a case sized to contain the instrument housing; and

a desiccant material inside the instrument housing or the case, the desiccant material being positioned external to the plurality of penetrating members.

34. The device of claim 33, wherein the desiccant is present in an amount of no more than 50 mm³ per each of an analyte detecting member.

35. The device of claim 33, wherein the desiccant is present in an amount of 10-20 mm³ per each of an analyte detecting member.

36. The device of claim 33, wherein the desiccant is present in an amount of 10-15 mm³ per each of an analyte detecting member.

37. The device of claim 33, wherein the desiccant is present in an amount of at least 1 mm³ per each of an analyte detecting member.

38. The device of claim 33, wherein the desiccant is selected from at least one of a molecular sieve, a silica gel or a clay.

39. The device of claim 38, wherein the molecular sieve is mixed with a polymeric binder.

40. The device of claim 33, further comprising

a scaffolding that supports the plurality of analyte detecting members.

41. The device of claim 40, wherein the scaffolding holds the desiccant.

42. The device of claim 41, wherein the scaffolding includes a desiccant for each of an analyte detecting member.

44. The device of claim 41, wherein the desiccant is molded and inserted into the scaffolding.

45. The device of claim 33, wherein the desiccant is coupled with the scaffolding.

46. The device of claim 33, wherein the desiccant and the scaffolding are co-molded simultaneously.

47. The device of claim 33, wherein the scaffolding and the desiccant are co-molded sequentially.

48. The device of claim 33, wherein the plurality of analyte detecting members and the plurality of penetrating members form a disposable device.

49. The device of claim 48, wherein the desiccant material is configured to be replaced when the disposable device is replaced from the instrument housing.

52. The device of claim 48, wherein the disposable device includes a plurality of cavities.

53. The device of claim 48, further comprising:

a cassette for housing the disposable device and sized to fit within the instrument housing.

54. The device of claim 53, wherein the plurality of penetrating members are at least partially contained in the cavities of the disposable device, wherein the penetrating members are slidably movable to extend outward from the disposable device to penetrate tissue, the cavities each having a longitudinal opening providing access to an elongate portion of the penetrating member.

55. The device of claim 54, wherein a sterility barrier covers a plurality of the longitudinal openings, wherein the sterility barrier is configured to be moved so that the elongate portion can be accessed by a gripper without touching the sterility barrier.

56. The device of claim 55, further comprising:

at least one gasket on the instrument housing to create a sealed air-tight environment inside the instrument housing.

59. The device of claim 48, wherein an air tight seal is formed around the disposable device.

60. The device of claim 33, wherein an air tight seal is formed around the instrument housing.

61. The device of claim 33, wherein the instrument housing is in a sealed case.

62. The device of claim 33, further comprising:

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

63. A method to determine an amount on an analyte in a body fluid sample by a user, comprising:

(a) providing an analyte measuring device that has a instrument housing, a plurality of penetrating members in the instrument housing, a plurality of analyte detecting members, and a desiccant material inside the instrument housing and positioned external to the plurality of penetrating members;

(b) desiccating the plurality of analyte detecting members with the desiccant that is external to the plurality of penetrating members;

(c) presenting a penetrating member and unused analyte detecting member of the analyte measurement device into an active position;

(d) firing the penetrating member to prick the skin and bring a fluid sample to the analyte detecting member; and

(e) measuring the analyte level.

64. The method of claim 63, wherein steps (a) through (e) are performed without the user directly handling the penetrating member to obtain a fresh penetrating member or load the penetrating member

65. The method of claim 63, wherein steps (a) through (e) are performed without the user coding the analyte measurement device.

66. The method of claim 63, wherein blood is applied to an analyte detection member during lancing.

67. The method of claim 66, wherein the application of blood to an analyte detection member during lancing occurs without removal and disposal of penetrating members from the analyte measurement device.

68. The method of claim 63, wherein steps (a) through (e) are performed without a separate step of apply blood to a analyte detection member after lancing.

69. The method of claim 63, wherein step (d) is performed without milking a wound.

70. The method of claim 63, wherein step (d) is performed using at least one of a penetrating member driver selected from, spring based, electro-mechanical based, magnetic driver based, and nanomuscle based.

71. The method of claim 63, wherein step (d) is performed with controlled velocity and depth of penetration.

72. The method of claim 63, further comprising:

returning the analyte measuring device to a storage condition without having to dispose of a used penetrating member or used analyte detecting members.

73. The method of claim 63, wherein the analyte measuring device is ready for the next lancing event without having to dispose of the used penetrating member or the used analyte detecting member.