SHALLOW IMPLANTABLE ANALYTE SENSOR WITH RAPID PHYSIOLOGICAL RESPONSE

• US 20170127989A1
• Filed: 08/22/2016
• Published: 05/11/2017
• Est. Priority Date: 03/31/2008
• Status: Abandoned Application

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Feldman, Benjamin J., Hoss, Udo, Cho, Hyun
• Application Number:
  US15/243,851
• Publication Number:
  US 20170127989A1
• Time in Patent Office: Days
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 2560/0252 using ambient temperature
• 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 5/002 Monitoring the patient using a local or closed circuit, e.g. in a room or building A61B5/0017 takes precedence
• CPC Class Codes: A61B 5/14532 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 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/685 Microneedles
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B

Abstract

Methods and devices to detect analyte in body fluid are provided. Embodiments include analyte sensors designed so that at least a portion of the sensor is positionable beneath a skin surface in the dermal layer.

Claims

1-48. -48. (canceled)

49. A method for in vivo detection of an analyte level in dermal fluid, comprising:

positioning an analyte sensor through an outer skin surface and into fluid contact with the dermal fluid in a dermal layer of a person'"'"'s body to monitor the analyte level in the dermal fluid, the analyte sensor including at least a working electrode positioned in the dermal layer; and

detecting a signal generated by the working electrode of the analyte sensor, wherein the signal corresponds to the analyte level in the dermal fluid,

wherein the working electrode of the analyte sensor does not extend beyond the thickness of the dermal layer under the outer skin surface.

50. The method of claim 49, wherein a sensing layer of the analyte sensor is in fluid contact with the dermal fluid.

51. The method of claim 50, wherein a membrane covers the sensing layer.

52. The method of claim 49, wherein the analyte sensor comprises:

a planar substrate comprising a first side and a second side that is opposite the first side; and

a second electrode,

wherein the working electrode is on the first side and the second electrode is on the second side, and

wherein positioning the analyte sensor through the outer skin surface and into fluid contact with the dermal fluid in the dermal layer comprises positioning the second electrode in the dermal layer.

53. The method of claim 49, wherein the analyte is glucose.

54. The method of claim 49, wherein positioning the analyte sensor includes manually penetrating the outer skin surface.

55. The method of claim 49, wherein the analyte sensor is positioned at a depth under the outer skin surface so that the position of the working electrode of the analyte sensor does not exceed approximately 2 millimeters in depth.

56. The method of claim 49, wherein the analyte sensor is positioned at a depth under the outer skin surface so that the position of the working electrode does not exceed approximately 1 millimeter in depth.

57. The method of claim 49, wherein the working electrode comprises an analyte-responsive enzyme and a mediator, and wherein at least one of the analyte-responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode.

58. The method of claim 57, wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer.

59. The method of claim 49, wherein the analyte sensor is configured to monitor one or more of lactate or ketone bodies in the dermal fluid.

60. An apparatus, comprising:

an analyte sensor configured to be positioned through an outer skin surface and configured to monitor an analyte level in dermal fluid in a dermal layer of a person'"'"'s body, the analyte sensor including at least a working electrode configured to be positioned in the dermal layer under the outer skin surface; and

sensor electronics configured to detect a signal generated by the working electrode of the analyte sensor, wherein the signal corresponds to the analyte level in the dermal fluid,

wherein the analyte sensor is configured such that, when positioned through the outer skin surface, the working electrode of the analyte sensor does not extend beyond the thickness of the dermal layer under the outer skin surface.

61. The apparatus of claim 60, wherein a sensing layer of the analyte sensor is configured for fluid contact with the dermal fluid.

62. The apparatus of claim 61, wherein a membrane covers the sensing layer.

63. The apparatus of claim 60, wherein the analyte sensor comprises:

a planar substrate comprising a first side and a second side that is opposite the first side; and

a second electrode configured to be positioned in the dermal layer,

wherein the working electrode is on the first side and the second electrode is on the second side.

64. The apparatus of claim 60, wherein the analyte is glucose.

65. The apparatus of claim 60, wherein the analyte sensor is configured so that the position of the working electrode of the analyte sensor does not exceed approximately 2 millimeters in depth under the outer skin surface.

66. The apparatus of claim 60, wherein the analyte sensor is configured so that the position of the working electrode does not exceed approximately 1 millimeter in depth under the outer skin surface.

67. The apparatus of claim 60, wherein the working electrode comprises an analyte-responsive enzyme and a mediator, and wherein at least one of the analyte-responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode.

68. The apparatus of claim 60, wherein the analyte sensor is configured to monitor one or more of lactate or ketone bodies in the dermal fluid.