Monitoring of physiological analytes

• US 20050215872A1
• Filed: 11/05/2004
• Published: 09/29/2005
• Est. Priority Date: 05/13/1998
• Status: Active Grant

• Current Assignee: LifeScan IP Holdings, LLC
• Original Assignee: Cygnus, Inc. (Johnson & Johnson)
• Inventors: Berner, Bret, Potts, Russell O., Chiang, Chia-Ming, Jona, Janan, Tamada, Janet A., Tierney, Michael J., Garrison, Michael D.
• Granted Patent: US 7,174,199 B2
• Time in Patent Office: Days
• US Class Current: 600/347
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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 5/150091 by electricity
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• CPC Class Codes: C12Q 1/006 for glucose

Abstract

Methods and devices are provided for measuring the concentration of target chemical analytes present in a biological system. Device configuration and/or measurement techniques are employed in order to reduce the effect of interfering species on sensor sensitivity. One important application of the invention involves a method and device for monitoring blood glucose values.

Claims

1-47. -47. (canceled)

48. A monitoring system for measuring an analyte present in one or more samples in a biological system, said monitoring system comprising:

a sampling device for providing one or more samples comprising said analyte, wherein said sampling device comprises one or more micro-needles;

a sensing device comprising a sensing electrode, wherein said sensing electrode obtains a measurement signal from the analyte in each of said samples, and said measurement signal is specifically related to the analyte amount or concentration in the biological system; and

one or more microprocessors in operative communication with the sensing device, wherein said one or more microprocessors comprise programming to control (i) operating said sensing device to provide said measurement signals, and (ii) applying one or more processes for selectively favoring analyte-specific signal components over signal components due to interfering species, said processes selected from the group consisting of (a) a selective electrochemical detection process that is performed during said obtaining, said process comprising contacting each of said samples with an electrochemical sensing electrode that is maintained at a potential less than about 0.6V, (b) a purge step that is performed before and/or after said obtaining, wherein said step substantially removes residual signal components from the sensing electrode, and (c) any combinations thereof.

49. The monitoring system of claim 48, wherein said one or more microprocessors are in operative communication with said sampling device and said one or more microprocessors further comprise programming to control operating said sampling device.

50. The monitoring system of claim 48, said sampling device further comprising one or more collection reservoirs.

51. The monitoring system of claim 50, wherein a sensing electrode is in operative contact with at least one of said one or more collection reservoirs.

52. The monitoring system of claim 50, wherein at least one of said one or more collection reservoirs comprises an ionically conductive material.

53. The monitoring system of claim 52, wherein said ionically conductive material further comprises an enzyme.

54. The monitoring system of claim 50, wherein at least one of said one or more collection reservoirs comprises a hydrogel.

55. The monitoring system of claim 54, wherein said hydrogel further comprises an enzyme.

56. The monitoring system of claim 48, wherein said sampling device further uses a sampling technique selected from the group consisting of iontophoresis, sonophoresis, suction, electroporation, thermal poration, passive diffusion, and use of laser devices.

57. The monitoring system of claim 48, wherein the analyte is glucose.

58. The monitoring system of claim 49, wherein said sampling device uses a sampling technique selected from the group consisting of iontophoresis, sonophoresis, suction, electroporation, thermal poration, passive diffusion, and use of laser devices.

59. The monitoring system of claim 49, wherein the analyte is glucose.

60. The monitoring system of claim 48, wherein said sensing electrode comprises a reactive surface comprising a platinum-group metal.

61. The monitoring system of claim 60, wherein said platinum-group metal is selected from the group consisting of platinum, palladium, rhodium, ruthenium, osmium, iridium, and combinations thereof.

62. The monitoring system of claim 60, wherein said sensing device further comprises an enzyme that reacts with the analyte to provide a chemical signal that is converted at said reactive surface to an electrical signal, wherein said electrical signal is related to analyte amount or concentration in the biological system.

63. The monitoring system of claim 62, wherein said chemical signal is hydrogen peroxide.

64. The monitoring system of claim 63, wherein said electrochemical sensing electrode is maintained at a potential of less than about 0.5 volts.

65. The monitoring system of claim 64, wherein said electrochemical sensing electrode is maintained at a potential of less than about 0.42 volts.

66. The monitoring system of claim 48, wherein said biological system is a mammal.

67. The monitoring system of claim 66, wherein said mammal is a human.