Analyte monitor

• US 6,923,764 B2
• Filed: 01/22/2003
• Issued: 08/02/2005
• Est. Priority Date: 06/27/2000
• Status: Expired due to Term

• Current Assignee: Intuity Medical, Inc.
• Original Assignee: Rosedale Medical Inc. (Intuity Medical, Inc.)
• Inventors: Loewy, Zvi Gerald, Zanzucchi, Peter John, Aceti, John Gregory, Gregory, Christopher Carter, Moroney, Richard Morgan III
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US10/347,620
• Publication Number:
  US 20030135333A1
• Time in Patent Office: 923 Days
• Field of Search: 600/309, 600/310, 600/316, 600/322, 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 wearable device constructed for automated detection of the concentration of an analyte present in a sampled body fluid, the device comprising:

a housing;

at least one needle adapted to pierce the skin;

at least one analysis site associated with the at least one needle;

a processor;

detection elements wherein the processor accepts data from the detection elements and derives normalized values therefrom; and

a controller constructed to monitor and control the device in a manner such that repeated detection of the concentration of the analyte present in the sampled body fluid can occur without the necessity of intervention by a wearer of the device.

2. The device of claim 1, wherein the wearer is a human, and device is wearable on one or more of the flowing areas of the body:

wrists, forearms, upper arms, torso, thighs, calves, and ankles.

3. The device of claim 1, further comprising a strap for securing the device to the body.

4. The device of claim 1, further comprising an adhesive for securing the device to the body.

5. The device of claim 1, wherein the analyte comprises glucose.

6. The device of claim 5, wherein the body fluid comprises at least one of:

interstitial fluid and blood.

7. The device of claim 1, wherein the housing is constructed such that it is not reversibly openable by the wearer, whereby the entire device is disposable.

8. The device of claim 1, further comprising:

an energy source; and

detection elements.

9. The device of claim 8, wherein the energy source is removable from the housing.

10. The device of claim 1, further comprising a cassette which is removable from the housing.

11. The device of claim 10, wherein the at least one needle and the at least one analysis site are mounted in the cassette.

12. The device of claim 11, wherein the power source is also mounted in the cassette.

13. The device of claim 1, wherein the at least one needle comprises a microneedle.

14. The device of claim 13, wherein the microneedle has a diameter of 200 μ

m or less.

15. The device of claim 13, wherein the microneedle has a diameter of 150 μ

m or less.

16. The device of claim 13, wherein the microneedle has a diameter of 100 μ

m or less.

17. The device of claim 13, wherein the microneedle has a diameter of 50 μ

m or less.

18. The device of claim 13, wherein the microneedle has a diameter of 25 μ

m or less.

19. The device of claim 13, wherein the microneedle is constructed from plastic, glass, silicon wafer, sapphire, quartz, or metal.

20. The device of claim 1, further comprising at least one actuator associated with the at least one needle.

21. The device of claim 20, wherein the actuator comprises at least one of a spring or electrically-driven device.

22. The device of claim 1, wherein the at least one analysis site comprises a support carrying a chemical reagent.

23. The device of claim 22, wherein the support comprises a porous membrane.

24. The device of claim 23, wherein the porous membrane has a pore density such that a beam of light incident therein sees a uniform density of pores.

25. The device of claim 23, wherein the membrane is constructed of nylon, polycarbonate, or polyvinylidene difluoride.

26. The device of claim 22, wherein the analysis site further comprises at least one light source and at least one light detector.

27. The device claim of claim 26, wherein the at least one light source comprises at least one LED.

28. The device of claim 26, wherein at least one light detector comprises at least one charge-coupled device, photodiode, or photodetector.

29. The device of claim 22, further comprising:

an array of individually addressable light emitting diodes; and

a charge-coupled device array, photodiode array, or photodetector array.

30. The device of claim 1, further comprising a visual display.

31. The device of claim 1, further comprising a sound generating device.

32. The device of claim 31, wherein the sound generating device can emit tones or synthesized speech.

33. The device of claim 1, further comprising a device for transmitting data or instructions to another device.

34. The device of claim 33, wherein the device for transmitting communicates via wire-mediated electronic communication, Rf signaling, or IR signaling.

35. The device of claim 33, wherein the other device comprises a device for delivering therapeutic substances, or a personal digital assistant.

36. The device of claim 1, further comprising a control package.

37. The device of claim 36, wherein the control package comprises a calibration control having a fixed concentration of the analyte.

38. The device of claim 1, further comprising a device for heating tissue from which the body fluid is to be sampled.

39. The device of claim 1, further comprising at least one near infra-red or visible light source adapted to heat tissue of the wearer.

40. A wearable device constructed for automated detection of the concentration of an analyte present in a sampled body fluid, the device comprising:

a housing;

a plurality of microneedles adapted to pierce the skin;

a plurality of analysis sites associated with the plurality of the microneedles; and

a controller constructed to monitor and control the device in a manner such that repeated detection of the concentration of the analyte present in the sampled body fluid can occur without the necessity of intervention by a wearer of the device.

41. The device of claim 40, wherein the plurality comprises at least 32 needles and associated analysis sites.

42. The device of claim 40, wherein the plurality comprises at least 160 needles and associated analysis sites.

43. The device of claim 40, wherein each of the plurality of microneedles is extendable to an extent sufficient to pierce the skin of the wearer.

44. A wearable device constructed for automated detection of the concentration of an analyte present in a sampled body fluid, the device comprising:

a housing;

at least one needle adapted to pierce the skin;

at least one analysis site associated with the at least one needle, the at least one analysis site comprises at least one chamber constructed of plastic, glass, silicon or quartz; and

a controller constructed to monitor and control the device in a manner such that repeated detection of the concentration of the analyte present in the sampled body fluid can occur without the necessity of intervention by a wearer of the device.

45. The device of claim 44, wherein the chamber is windowed.

46. The device of claim 44, wherein the chamber is sized to draw a volume of body fluid of approximately 5,000 nL or less.

47. The device of claim 46, wherein the chamber is sized to draw a volume of body fluid of approximately 300 nL or less.

48. The device of claim 44, further comprising a septum attached to the chamber.

49. The device of claim 48, wherein the chamber is evacuated.

50. The device of claim 49, wherein the needle comprises a first end adapted to puncture the skin of the wearer, and a second end adapted to puncture the septum, thereby allowing the vacuum with the chamber to be applied to the interior of the needle.

51. The device of claim 49, wherein the needle comprises a first end adapted to puncture the skin of the wearer, and a side hole adapted to communicate with the vacuum existing within the chamber.

52. The device of claim 44, further comprising a pump associated with the at least one chamber for evacuating the chamber.

53. A wearable device constructed for automated detection of the concentration of an analyte present in a sampled body fluid, the device comprising:

a housing;

at least one needle adapted to pierce the skin;

at least one analysis site associated with the at least one needle, the at least one analysis site comprises a reagent adapted to react with the analyte to produce a detectable signal, and capable of producing an optically readable signal upon reaction with the analyte; and

a controller constructed to monitor and control the device in a manner such that repeated detection of the concentration of the analyte present in the sampled body fluid can occur without the necessity of intervention by a wearer of the device.

54. The device of claim 53, wherein the reagent creates a fluorescent signal upon reaction with the analyte.

55. A wearable device constructed for automated detection of the concentration of an analyte present in a sampled body fluid, the device comprising:

a housing;

at least one needle adapted to pierce the skin;

at least one analysis site associated with the at least one needle;

at least once actuating device;

at least one light emitting device;

at least one light detection element;

a controller constructed to monitor and control the device in a manner such that repeated detection of the concentration of the analyte present in the sampled body fluid can occur without the necessity of intervention by a wearer of the device; and

wherein the controller keeps track of the number of used needles and analysis sites, operates the at least one actuating device, operates the at least one light emitting device, and collects raw data from the at least one light detection element and performs calculations therewith.

56. A method for periodically and automatically detecting concentration of an analyte present in a sampled body fluid, the method comprising:

(i) attaching an analyte monitoring device to a wearer, the device comprising at least one needle, at least one analysis site associated with the at least one needle, and a controller;

(ii) causing the at least one needle to penetrate the skin of the wearer;

(iii) transporting a sample of body fluid to the at least one analysis site using capillary action;

(iv) performing an assay on the sample thereby determining the concentration of the analyte in the sample of body fluid.

57. The method of claim 56, wherein steps (ii)-(iv) are governed by the controller such that they are performed without the necessity of intervention by a wearer of the device.

58. The method of claim 56, wherein step (i) comprises attaching the device to the wrist, upper arm, torso, thighs, calves, or ankles of the wearer.

59. The method of claim 56, wherein the analyte comprises glucose and the body fluid comprises interstitial fluid or blood.

60. The method of claim 56, wherein the needle comprises a microneedle.

61. The method of claim 56, wherein step (ii) comprises actuating the needle with at least one of a spring or electrically driven device.

62. The method of claim 56, wherein steps (iii) comprises using a vacuum to facilitate transportation of the sample to the analysis site.

63. The method of claim 56, wherein step (iv) comprise reacting the sample of body fluid with a chemical reagent, producing an optically readable signal, detecting the signal to provide data, and calculating a result therefrom.

64. The method of claim 56, further comprising the step of:

(v) transmitting data obtained from step (iv) to another device.

65. The method of claim 64, wherein step (v) comprises wire-mediated transmission, Rf signaling, or IR signaling.

66. The method of claim 64, wherein the other device comprises a device for the delivery of therapeutic substances or a personal data assistant.

67. A method for automatically detecting concentration of an analyte present in a sampled body fluid, the method comprising:

(i) attaching an analyte monitoring device to a wearer, the device comprising a least one analysis site, and a controller;

(ii) obtaining a sample of body fluid from the wearer;

(iii) transporting the sample of body fluid to the at least one analysis site using capillary action;

(iv) performing an assay on the sample for determining the concentration of the analyte in the sample of body fluid; and

(v) automatically repeating steps (ii)-(iv) without the necessity of intervention by the wearer.

68. The method of claim 67, wherein step (v) is initiated by the controller.

69. The method of claim 67, wherein step (ii) comprises causing at least one of a plurality of microneedles to pierce the skin of the wearer.

70. The method of claim 69, wherein step (ii) comprises actuating the microneedle with at least one of a spring or electrically driven device.

71. The method of claim 67, wherein step (i) comprises attaching the device to the wrist, upper arm, torso, thighs, calves, or ankles of the wearer.

72. The method of claim 67, wherein the analyte comprises glucose and body fluid comprises interstitial fluid or blood.

74. The method of claim 67, wherein step (iv) comprises reacting the sample of body fluid with a chemical reagent, producing an optically readable signal, detecting the signal to produce data, and calculating results therefrom.

75. The method of claim 67, further comprising the step of transmitting data obtained from step (iv) to another device.

76. The method of claim 75, wherein the step of transmitting data comprises wire-mediated transmission, Rf signaling, or IR signaling.

77. The method of claim 75, wherein the other device comprises a device for the delivery of therapeutic substances or a personal data assistant.

73. The method of claim step (iii) comprises using a vacuum to facilitate transportation of the sample to the analysis site.

78. A wearable device constructed for automated periodic detection of the concentration of glucose present in a sampled body fluid, the device comprising:

a housing;

at least one micro-needle adapted to pierce the skin;

at lease one reagent associated with the at least once micro-needle; and

a controller constructed to monitor and control the device in a manner such that repeated periodic detection of the concentration of glucose present in the sampled body fluids occurs at predetermined times without the necessity of intervention by a wearer of the device.

79. The device of claim 78, wherein the wearer is a human.

80. The device of claim 78, wherein the body fluid comprises at least one of blood and interstitial fluid.

81. The device of claim 78, further comprising a housing and a cartridge, the cartridge being separable from the housing.

82. The device of claim 81, wherein the at least one micro-needle and the at least one reagent is disposed in the cartridge.

83. The device of claim 82, wherein the device further comprises a battery, the battery being disposed in the cartridge.

84. The device of claim 83, wherein the device further comprises sensors, the sensors being disposed within the housing.

85. The device of claim 84, wherein the device further comprises electronic components, the electronic components being disposed within the housing.

86. The device of claim 78, wherein the at least one micro-needle is formed from metal.

87. The device of claim 78, wherein the at least one micro-needle comprises an array of micro-needles.

88. The device of claim 78, further comprising at least one of a display, a keypad, and an alarm.

89. The device of claim 78, further comprising an infrared radiation source.

90. A method for automatically detecting concentration of glucose present in a sampled body fluid, the method comprising:

(i) attaching a glucose monitoring device to a wearer, the device comprising at least one micro-needle and at least one reagent associated with the at least one micro-needle, and a controller;

(ii) obtaining a sample of body fluid from the wearer;

(iii) transporting the sample of body fluid to the reagent;

(iv) performing an assay on the sample for determining the concentration of glucose in the sample of body fluid; and

(v) automatically repeating steps (ii)-(iv) without the necessity of intervention by the wearer.

91. The method of claim 90, wherein step (ii) further comprises extending a micro-needle into the skin of the wearer at a predetermined time.

92. The method of claim 91, further comprising the step of withdrawing the micro-needle from the skin of the wearer.

93. The method of claim 90, wherein step (iii) further comprises wicking the sample to the reagent.

94. The method of claim 90, further comprising the step of displaying the concentration of glucose measure in step (iv).

95. The method of claim 90, further comprising generating an alarm when the concentration of glucose measured in step (iv) falls below a predetermined value.

96. The method of claim 90, further comprising transmitting data to another device.

97. The method of claim 96, wherein in data comprises the glucose concentration measured in step (iv).