ANALYTE SENSOR AND APPARATUS FOR INSERTION OF THE SENSOR

• US 20100324392A1
• Filed: 02/01/2010
• Published: 12/23/2010
• Est. Priority Date: 02/03/2009
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Love, Michael Raymond, Hoss, Udo, He, Lei, Yee, Phillip, Thomas, Christopher Allen
• Granted Patent: US 9,402,544 B2
• Time in Patent Office: Days
• US Class Current: 600/345
• CPC Class Codes: A61B 2560/0214 of power generation or supply
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2560/0475 Special features of memory means, e.g. removable memory cards
• CPC Class Codes: A61B 2560/0487 Special user inputs or interfaces
• 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 5/0004 characterised by the type of physiological signal transmitted
• CPC Class Codes: A61B 5/002 Monitoring the patient using a local or closed circuit, e.g. in a room or building A61B5/0017 takes precedence
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/0024 for multiple sensor units attached to the patient, e.g. using a body or personal area network
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/6849 in combination with a needle set
• CPC Class Codes: A61B 5/6898 Portable consumer electronic devices, e.g. music players, telephones, tablet computers
• CPC Class Codes: A61B 5/72 Signal processing specially adapted for physiological signals or for diagnostic purposes character recognition, recognising digital ink, document-oriented image-based pattern recognition G06V30/00; recognition or understanding of postal images G06V30/424
• CPC Class Codes: A61B 5/7405 using sound
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/7425 Displaying combinations of multiple images regardless of image source, e.g. displaying a reference anatomical image with a live image geometric transforms for image registration G06T3/14; enhancement using image fusion G06T5/50; algorithms for registration of images G06T7/30
• CPC Class Codes: A61B 5/7455 characterised by tactile indication, e.g. vibration or electrical stimulation
• CPC Class Codes: A61M 2005/1726 : the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2205/33 : Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/3584 : using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/502 : User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2230/201 : Glucose concentration
• CPC Class Codes: A61M 5/158 : Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/1723 : using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61M 5/3286 : Needle tip design, e.g. for improved penetration
• CPC Class Codes: C12Q 1/001 : Enzyme electrodes
• CPC Class Codes: C12Q 1/006 : for glucose
• CPC Class Codes: G06K 7/10366 : the interrogation device being adapted for miscellaneous applications
• CPC Class Codes: H04L 67/12 : specially adapted for proprietary or special-purpose networking environments, e.g. medical networks, sensor networks, networks in vehicles or remote metering networks

Abstract

An apparatus for insertion of a medical device in the skin of a subject is provided.

Claims

1. A sensor comprising:

a body having a proximal section, a distal section longitudinally aligned with the proximal section, and an intermediate section,

wherein the intermediate section is laterally displaced from at least the distal member and a gap is defined between the laterally displaced intermediate section and a portion of the distal section.

2. The sensor of claim 1, wherein the intermediate section is laterally displaced from at least a portion of the proximal section of the sensor body.

3. The sensor of claim 2, wherein a second gap is defined between the laterally displaced intermediate section and the proximal section of the sensor body.

4. The sensor of claim 1, wherein the intermediate section has a distal end and a proximal end, and further wherein the proximal section is coupled to the proximal section and the distal section is coupled to the distal section of the sensor body.

5. The sensor of claim 4, wherein the intermediate section is a longitudinal member.

6. The sensor of claim 1, wherein the distal section has a proximal end and a distal end.

7. The sensor of claim 6, wherein the proximal end is proximate to the gap defined between the distal member and the intermediate member.

8. The sensor of claim 7, wherein the proximal end is received within a needle seat to create an anchor region to allow the sensor body to slide into a slot defined in the insertion needle but prevent the sensor body from slipping out of the insertion needle.

9. The sensor of claim 8, wherein a width of the distal section of the sensor body has a width sized to fit within the slot of the insertion sharp having a diameter less than about 22 to about 26 gauge.

10. The sensor of claim 1, wherein the intermediate member includes a bendable portion.

11. The sensor of claim 10 wherein the bendable portion allows the proximal section of the sensor body to be in a plane different than the distal section of the sensor body.

12. The sensor of claim 11, wherein the proximal section and the distal section are in planes perpendicular to each other.

13. The sensor of claim 1, wherein the proximal section has a curved portion.

14. The sensor of claim 1, wherein sensor is configured in a bent configuration.

15. The sensor of claim 1, wherein the sensor body includes conductive material disposed on a surface thereto to define one or more electrodes.

16. The sensor of claim 1, wherein the sensor body 15 includes conductive material defining traces disposed on a surface of the sensor body.

17. The sensor of claim 16, wherein the traces are in communication with the one or more electrodes.

18. The sensor of claim 16, wherein the traces are disposed on at least surface of the proximal section of the sensor body.

19. The sensor of claim 17, wherein the one or more electrodes are disposed on the distal section of the sensor body.

20. The sensor of claim 17, wherein at least one of the traces or electrodes comprise gold.

21. The sensor of claim 20, wherein at least one of the traces or electrodes are formed by ablation.

22. The sensor of claim 21, wherein the ablation comprises laser ablation.

23. The sensor of claim 1, wherein the sensor comprises a sensing layer.

24. The sensor of claim 23, wherein the sensing layer comprises an electron transfer agent.

25. The sensor of claim 24, wherein the electron transfer agent is a redox mediator.

26. The sensor of claim 1, wherein the sensor is a subcutaneous sensor.

27. A sensor assembly comprising:

a mount adapted to adhere to a skin of a subject;

a sensor coupled to the mount, the sensor including a body having a proximal section, a distal section longitudinally aligned with the proximal section, and an intermediate section, wherein the intermediate section is laterally displaced from at least the distal member and a gap is defined between the laterally displaced intermediate section and a portion of the distal section, and

an insertion sharp having a longitudinal body including a longitudinal opening to receive at least a portion of the sensor body.

28. The sensor assembly of claim 27, wherein the sensor is integrated with the mount to define an on-body device.

29. The sensor assembly of claim 27, wherein a second gap is defined between the proximal section and the laterally displaced intermediate section.

30. The sensor assembly of claim 27, wherein the proximal section has a substantially curved profile.

31. The sensor assembly of claim 27, wherein the distal section of the sensor body is received in the longitudinal wall gap of the insertion needle.

32. The sensor assembly of claim 31, wherein a gap defined between the distal section and the laterally displaced intermediate section allows the entirety of the distal section to be received in the longitudinal slot of the insertion needle.

33. The sensor assembly of claim 32, wherein the intermediate section and the proximal section are proximate the distal section received in the insertion needle.

34. The sensor assembly of claim 33, wherein the proximal section of the sensor body is in communication with conductive material disposed on the mount.

35. The sensor assembly of claim 34, wherein the conductive material disposed on the mount defines a printed circuit board.

36. The sensor of claim 27, wherein the proximal section of the sensor is disposed in a first plane, and the distal section of the sensor body is disposed in a second plane.

37. The sensor of claim 27, wherein the sensor is a transcutaneous sensor.

38. The sensor of claim 27, wherein the sensor is configured for implantation in a soft tissue of a user.

39. The sensor of claim 27, wherein the sensor is a glucose sensor.

40. A sensor assembly comprising:

a sensor comprising a portion for operative contact with a fluid of the subject;

a mount defining distal surface adapted for attachment to the skin of a subject and housing a circuit coupled to sensor for performing a function with the sensor; and

a switch at least partially disposed in the mount comprising a member having a first position which protrudes from the distal surface of the mount and a second position which is recessed in the mount, the member configured to activate the circuit when in the second position.

41. The sensor assembly of claim 40, wherein the member is biased in the first position.

42. The sensor assembly of claim 40, wherein the member comprises an elongated member disposed in an opening in the mount.

43. The sensor assembly of claim 40, wherein the member is moved from the first position to the second position when the mount contacts the skin of the subject.

44. The sensor assembly of claim 40, further comprising an adhesive layer disposed on the skin of the subject, and wherein the member is moved from the first position to the second position when the mount contacts the adhesive layer.

45. The sensor assembly of claim 40, wherein the switch activates the circuit upon the member reaching the second position.

46. The sensor assembly of claim 40, wherein the switch activates the circuit as long as the member is maintained in the second position.

47. The sensor assembly of claim 40, wherein the sensor is a glucose sensor.

48. The sensor assembly of claim 40, wherein the circuit applies a potential to the sensor.

49. The sensor assembly of claim 40, wherein the circuit applies a current to the sensor.

50. The sensor assembly of claim 40, further comprising a monitor unit, and wherein the circuit comprises a communication circuit to provide a signal relating an analyte level provided by the sensor to the monitor unit.

51. The sensor assembly of claim 50, wherein the communications circuit provides the signal to the monitor unit automatically.

52. The sensor assembly of claim 50, wherein the communications circuit provides the signal to the receiver on demand.

53. The sensor assembly of claim 40, further comprising a memory, and wherein the circuit stores a signal relating an analyte level provided by the sensor to the memory.

54. The sensor of claim 40, wherein the sensor is a glucose sensor.

55. An apparatus for inserting a medical device through the skin of a subject, which comprises:

a sheath defining a distal surface for placement on the skin of the subject;

a handle movable between a proximal position and distal position relative to the sheath;

a device support for supporting the medical device and defining an aperture therethrough;

a sharp support for supporting a sharp extending through said aperture and coupled to the handle; and

a driver for biasing the handle and the sharp support towards the proximal position.

56. The apparatus of claim 55, wherein the driver comprises a compression spring.

57. The apparatus of claim 55, wherein the handle is at least partially disposed within the sheath.

58. The apparatus of claim 55, wherein the handle is at least partially disposed surrounding the sheath.

59. The apparatus of claim 55, wherein the sharp support is permanently fixed to the handle.

60. The apparatus of claim 55, wherein the device support is permanently affixed to the handle.

61. The apparatus of claim 55, wherein the device support is coupled to the sharp support until the device support reaches a distal position.

62. The apparatus of claim 61, wherein the device support is uncoupled from the sharp support when the device support reaches the distal position.

63. The apparatus of claim 55, wherein the medical device is an analyte sensor.

64. The apparatus of claim 55, wherein the medical device is a glucose sensor.

65. The apparatus of claim 55, wherein the medical device is an infusion set.

66. A method, comprising:

positioning a distal end of an elongated housing on a skin surface;

applying a predetermined force on the housing to displace an analyte monitoring assembly operatively coupled to an introducer mechanism from a first position within the elongated housing to a second position where at least a portion of an analyte sensor of the analyte monitoring assembly is in contact with an analyte under the skin surface, and further, wherein a distal surface of the analyte monitoring assembly is positioned on the skin surface; and

automatically retracting the introducer mechanism from the second position to the first position to be entirely retained within the elongated housing.

67. The method of claim 66, further comprising, prior to positioning the distal end of the elongated housing, disengaging an end cap from a bottom end of the elongated housing of an insertion device to expose the interior space of the housing;

68. The method of claim 66, wherein automatically retracting the introducer mechanism comprises automatically retracting the introducer mechanism upon the introducer mechanism reaching a predetermined distalmost position.

69. The method of claim 68, further comprising disengaging the introducer mechanism from a retention member upon reaching the predetermined distalmost position.

70. The method of claim 66, further comprising preventing the displacement of the analyte monitoring assembly within the hollow space between the first position and the second position when the end cap is engaged with the bottom end of the elongated housing.

71. The method of claim 66 further comprising providing an adhesive layer along the periphery of the distal end of the opening of the elongated housing.

72. The method of claim 66 wherein the analyte sensor comprises a glucose sensor.

73. The method of claim 66 further comprising maintaining a power source of the analyte monitoring assembly in an inactive state when the analyte monitoring assembly is positioned at or near one of the first position or the second position.

74. The method of claim 66 further comprising engaging the analyte monitoring assembly with at least a portion of the introducer mechanism within the hollow space in the housing during displacement between the first position and the second position.

75. The method of claim 66 further comprising providing a bias mechanism within the hollow space of the elongated housing to automatically retract the introducer mechanism from the second position to the first position.

76. The method of claim 66 further comprising entirely retaining the introducer mechanism within the elongated housing when the introducer mechanism is displaced to the second position.

77. The method of claim 66 wherein the first position comprises a sensor predeployment position and further, wherein the second position comprises a sensor insertion position.

78. The assembly of claim 66 wherein the analyte sensor electronic circuit is activated when the analyte monitoring assembly is at or near the second position.

79. The method of claim 66 further comprising positing a portion of the analyte monitoring assembly on a skin surface at the second position.

80. The method of claim 79 further comprising activating the analyte monitoring assembly when the portion of the analyte monitoring assembly is positioned on the skin surface.

81. The method of claim 66 further comprising positioning at least a portion of the analyte sensor in fluid contact with an analyte under a skin layer at the second position.

82. The method of claim 66 further comprising providing the analyte sensor to the analyte monitoring assembly such that the analyte sensor retains a bent characteristics at the first position and the second position.

83. The method of claim 66 further comprising providing one or more data associated with a monitored level of an analyte to a remote location.

84. The method of claim 83 wherein providing the one or more data comprises using one or more of RF communication, infrared communication, Bluetooth communication, Zigbee communication, 802.1x communication, or WiFi communication.

85. The method of claim 84 wherein the remote location includes one or more of a remotely located computing device, a mobile telephone device, a personal digital assistant, or a communication enabled data processing device.

86. An integrated assembly, comprising:

a sensor electronics assembly comprising;

an analyte sensor;

a power supply;

an activation switch operatively coupled to the power supply and the analyte sensor;

a control unit in electrical contact with the analyte sensor and the activation switch having one or more programming instructions stored therein for execution, the control unit configured to process one or more signals received from the analyte sensor when the activation switch is triggered; and

an insertion device comprising;

a housing;

an introducer coupled to the housing configured to move between a first position and a second position; and

a bias mechanism operatively coupled to the housing configured to retract the introducer from the second position to the first position.

87. The assembly of claim 86 wherein the sensor electronics assembly is retained entirely within the housing of the insertion device prior to the introducer movement from the first position to the second position

88. The assembly of claim 86 wherein the activation switch is not triggered until the introducer has reached the second position.

89. The assembly of claim 86 wherein the analyte sensor comprises a glucose sensor.

90. The assembly of claim 86 wherein the activation switch is triggered after sensor transcutaneous positioning with the introducer, and prior to the introducer retraction from under the skin layer.

91. The assembly of claim 86 wherein the introducer engages with the analyte sensor during its movement from the first position to the second position, and further, wherein the introducer disengages from the analyte sensor during its movement from the second position to the first position.

92. The assembly of claim 86 wherein the movement of the introducer from the first position to the second position is in response to a manual force applied on the housing.

93. The assembly of claim 86 wherein the bias mechanism comprises a spring.

94. The assembly of claim 86 including an adhesive layer provided on a distal surface of the housing for placement on a skin layer.

95. The assembly of claim 94 wherein the adhesive layer is configured to retain the sensor electronics assembly on the skin layer for a predetermined time period.

96. The assembly of claim 86 wherein the power supply includes a single use disposable battery.

97. The assembly of claim 86 wherein the active operational life of the power supply exceeds the active operational life of the analyte sensor.

98. The assembly of claim 86 further comprising a cap configured to mate with an open end of the housing of the insertion device.

99. The assembly of claim 98 wherein when the cap is coupled to the housing, the interior space of the housing is maintained in a substantially contaminant free environment.

100. The assembly of claim 86 wherein the sensor electronics assembly further comprises a printed circuit board including a portion of the analyte sensor permanently connected thereto.

101. The assembly of claim 86 wherein the control unit comprises an application specific integrated circuit (ASIC).

102. The assembly of claim 86 wherein the movement of the introducer between the first position and the second position is at an angle at approximately 90 degrees or less from the skin surface.

103. The assembly of claim 86 wherein the sensor electronics assembly includes a housing having a height of less than approximately 4 mm.

104. The assembly of claim 86 wherein at least a portion of the analyte sensor, the entire power supply, the entire activation switch and the entire control unit are provided within the housing.

105. The assembly of claim 86 wherein the activation switch is manually triggered.