Integrated Meter for Analyzing Biological Samples

• US 20100286563A1
• Filed: 07/26/2010
• Published: 11/11/2010
• Est. Priority Date: 11/30/2005
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Schoenberg, Stephen J., Giraud, Jean-Pierre, Bryer, Philip, Lee, Irving, Berken, Lloyd M.
• Granted Patent: US 8,435,447 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• 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 5/150183 Depth adjustment mechanism using end caps mounted at the distal end of the sampling device, i.e. the end-caps are adjustably positioned relative to the piercing device housing for example by rotating or screwing
• 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 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• 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 5/150664 Pivotable protective sleeves, i.e. sleeves connected to, or integrated in, the piercing or driving device, and which are pivoted for covering or uncovering the piercing element
• CPC Class Codes: A61B 5/150702 fully automatically removed, i.e. the removing does not require any action by the user
• CPC Class Codes: A61B 5/150786 Optical identification systems, e.g. bar codes, colour codes
• CPC Class Codes: A61B 5/150793 Electrical or magnetic identification means
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• 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 5/15128 comprising 2D- or 3D-shaped elements, e.g. cams, curved guide rails or threads comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15132 comprising tooth-shaped elements, e.g. toothed wheel or rack and pinion
• 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 5/15174 : Piercing elements stocked in the form of a stack or pile
• CPC Class Codes: A61B 5/15176 : Stocking means comprising cap, cover, sheath or protection for aseptic stocking
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: C12Q 1/005 : involving specific analytes or enzymes including groups of enzymes, e.g. oxydases; C12Q1/004 takes precedence
• CPC Class Codes: C12Q 1/54 : involving glucose or galactose
• CPC Class Codes: G01N 33/4875 : Details of handling test elements, e.g. dispensing or storage, not specific to a particular test method test-elements per se B01L, automatic analysers G01N35/00, in-vivo analysis on the human body for medical diagnosis A61B
• CPC Class Codes: G01N 33/54386 : Analytical elements
• CPC Class Codes: Y10T 436/144444 : Glucose
• CPC Class Codes: Y10T 436/200833 : Carbonyl, ether, aldehyde or ketone containing

Abstract

Analyte monitoring devices and methods therefore are provided. The devices integrate various functions of analyte monitoring, e.g., sample acquisition and testing.

Claims

1-30. -30. (canceled)

31. A method of measuring an analyte level for a fluid sample using an analyte testing meter comprising:

providing a cartridge within a housing of the meter, the cartridge including a plurality of analyte testing structures;

advancing an analyte testing structure of the plurality of analyte testing structures to a mechanical component including a slot for holding the analyte testing structure, wherein the analyte testing structure is advanced into a first end of the slot by a pusher and held within the slot;

electrically coupling contacts on the analyte testing structure to contacts on the meter when the analyte testing structure is held within the slot;

contacting the analyte testing structure to a fluid sample;

measuring an analyte level for the fluid sample; and

removing the analyte testing structure out of a second end of the slot for disposal of the analyte testing structure from the meter.

32. The method of claim 31, wherein the pusher comprises a flexible piece of material.

33. The method of claim 31, wherein the pusher comprises a chain and an end piece for contacting the analyte testing structure.

34. The method of claim 31, wherein the advancing of the analyte testing structure comprises the pusher bending along a curved inner wall surface within the housing.

35. The method of claim 31, wherein the advancing of the analyte testing structure comprises the pusher extending along a dimension of the housing and bending around one or more corners of the housing.

36. The method of claim 31, wherein the advancing of the analyte testing structure comprises the pusher unwinding from a coil.

37. The method of claim 31, wherein the advancing of the analyte testing structure comprises the pusher moving along a curved track within the housing.

38. The method of claim 31, further comprising:

providing a sealed environment for the plurality of analyte testing structures within the housing; and

unsealing the sealed environment to remove the analyte testing structure for advancement to the slot.

39. The method of claim 38, wherein the unsealing of the sealed environment comprises unsealing a tub from a cartridge, the cartridge held within an interior space within the housing and containing the plurality of analyte testing structures.

40. The method of claim 38, wherein the sealed environment maintains the analyte testing structures within the cartridge free from exposure to ambient air.

41. The method of claim 31, wherein the cartridge comprises at least one guide rail for relative positioning within the housing with respect to the set of components.

42. The method of claim 31, further comprising:

biasing the plurality of analyte testing structures toward a dispensing end of the cartridge.

43. The method of claim 31, further comprising:

advancing a lancet to contact a lancing site.

44. The method of claim 31, wherein the measuring of the analyte level comprises measuring a level of glucose or ketone bodies.

45. The method of claim 31, further comprising:

driving one or more components of the analyte testing meter with at least one motor.

46. The method of claim 45, further comprising:

determining the position and speed of respective components which the at least one motor drives using a plurality of electro-optical encoders associated with the at least one motor.

47. An analyte testing meter, comprising:

a housing;

a cartridge containing a plurality of analyte testing structures, the cartridge held within an interior space within the housing; and

a set of mechanical components including;

a pusher that advances an analyte testing structure from the cartridge;

a slot that holds the analyte testing structure when the analyte testing structure is advanced into a first end of the slot by the pusher; and

an electrical connector that electrically couples the analyte testing structure to the meter when the analyte testing structure is held in the slot, the electrical connector enabling a measurement of an analyte level for a fluid sample in contact with the analyte testing structure held in the slot;

wherein the slot permits the removal of the analyte testing structure out a second end of the slot for disposal from the meter after a measurement is performed.

48. The analyte test meter of claim 47, wherein the pusher comprises a flexible piece of material.

49. The analyte test meter of claim 47, wherein the pusher comprises a chain and an end piece for contacting the analyte testing structure.

50. The analyte test meter of claim 47, further comprising:

a curved inner wall surface within the housing, wherein the pusher bends around the curved inner wall surface when advancing the analyte testing structure.

51. The analyte test meter of claim 47, wherein the pusher extends along a dimension of the housing and bends around one or more corners of the housing when advancing the analyte testing structure.

52. The analyte test meter of claim 47, wherein the pusher winds and unwinds from a coil.

53. The analyte test meter of claim 47, wherein the pusher moves along a curved track within the housing.

54. The analyte test meter of claim 47, wherein the cartridge comprises at least one guide rail for relative positioning within the housing with respect to the set of components.

55. The analyte test meter of claim 47, further comprising:

a seal which generally maintains the plurality of analyte testing structures within the cartridge free from exposure to ambient air, and wherein the analyte test meter is configured to release the seal temporarily to permit advancement of the analyte testing structure to the slot.

56. The analyte test meter of claim 55, wherein the seal is between the cartridge and a tub, and wherein the releasing of the seal comprises moving the tub away from the cartridge.

57. The analyte test meter of claim 47, further comprising:

a biasing member at a loading end of the cartridge for biasing the plurality of analyte testing structures toward a dispensing end of the cartridge.

58. The analyte test meter of claim 47, further comprising:

a mechanical component that advances a lancet to contact a lancing site.

59. The analyte test meter of claim 47, wherein the analyte level comprises a level of glucose or ketone bodies.

60. The analyte test meter of claim 47, wherein the set of components further includes at least one motor for driving one or more components within the analyte testing meter.

61. The analyte test meter of claim 60, further comprising:

a plurality of electro-optical encoders associated with the at least one motor for determining the position and speed of respective components which are driven.

62. The analyte test meter of claim 61, further comprising:

a plurality of sensors positioned within the housing along a path traversed by an element, wherein the encoders and sensors function within a closed loop control system.

63. A set of mechanical components for use in an analyte testing meter, the set of mechanical components comprising:

a pusher that advances an analyte testing structure from a cartridge stored within an analyte testing meter, the cartridge containing a plurality of analyte testing structures;

a slot that holds the analyte testing structure when the analyte testing structure is advanced into a first end of the slot by the pusher; and

an electrical connector that electrically couples the analyte testing structure to the meter when the analyte testing structure is held in the slot, the electrical connector enabling a measurement of an analyte level for a fluid sample in contact with the analyte testing structure held in the slot;

wherein the slot permits the removal of the analyte testing structure out a second end of the slot for disposal from the meter after a measurement is performed.

64. The set of mechanical components of claim 63, wherein the pusher comprises a flexible piece of material.

65. The set of mechanical components of claim 63, wherein the pusher comprises a chain and an end piece for contacting the analyte testing structure.

66. The set of mechanical components of claim 63, further comprising:

a curved inner wall surface within the housing, wherein the pusher bends around the curved inner wall surface when advancing the analyte testing structure.

67. The set of mechanical components of claim 63, wherein the pusher extends along a dimension of the housing and bends around one or more corners of the housing when advancing the analyte testing structure.

68. The set of mechanical components of claim 63, wherein the pusher winds and unwinds from a coil.

69. The set of mechanical components of claim 63, further comprising:

a curved track within the housing, wherein the pusher moves along the curved track.

70. The set of mechanical components of claim 63, wherein the cartridge comprises at least one guide rail for relative positioning within the housing with respect to the set of components.

71. The set of mechanical components of claim 63, further comprising:

a seal which generally maintains the plurality of analyte testing structures within the cartridge free from exposure to ambient air, and wherein the analyte test meter is configured to release the seal temporarily to permit advancement of the analyte testing structure to the slot.

72. The set of mechanical components of claim 66, wherein the seal is between the cartridge and a tub, and wherein the releasing of the seal comprises moving the tub away from the cartridge.

73. The set of mechanical components of claim 63, further comprising:

a biasing member at a loading end of the cartridge for biasing the plurality of analyte testing structures toward a dispensing end of the cartridge.

74. The set of mechanical components of claim 63, further comprising:

a mechanical component that advances a lancet to contact a lancing site.

75. The set of mechanical components of claim 63, wherein the analyte level comprises a level of glucose or ketone bodies.

76. The set of mechanical components of claim 63, further comprising:

at least one motor for driving one or more components within the analyte testing meter.

77. The set of mechanical components of claim 76, further comprising:

a plurality of electro-optical encoders associated with the at least one motor for determining the position and speed of respective components which are driven.

78. The set of mechanical components of claim 77, further comprising:

a plurality of sensors positioned within the housing along a path traversed by an element, wherein the encoders and sensors function within a closed loop control system.