ROD SHAPED IMPLANTABLE BIOSENSOR

• US 20150366493A1
• Filed: 09/17/2013
• Published: 12/24/2015
• Est. Priority Date: 09/17/2012
• Status: Abandoned Application

• Current Assignee: Brains Online Holding B.V.
• Original Assignee: Brains Online Holding B.V.
• Inventors: Cremers, Thomas Ivo Franciscus Hubert
• Application Number:
  US14/428,492
• Publication Number:
  US 20150366493A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2562/12 Manufacturing methods specially adapted for producing sensors for in-vivo measurements
• 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 5/4362 Assessing foetal parameters
• CPC Class Codes: A61B 5/6848 Needles
• 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: C23C 14/16 on metallic substrates or on substrates of boron or silicon
• CPC Class Codes: C23C 16/06 characterised by the deposition of metallic material
• CPC Class Codes: G01N 2333/90241 acting on single donors with incorporation of molecular oxygen, i.e. oxygenases (1.13)
• CPC Class Codes: G01N 27/3271 Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood amperometry per se G01N27/49; aspects concerning the enzyme reagent C12Q1/001
• CPC Class Codes: Y10T 29/49206 by powder metallurgy

Abstract

A biosensor includes a biosensor unit with an electrode, wherein the electrode is rod-shaped, wherein the electrode further comprises a support with an electrically conductive first layer and an exclusion layer, wherein the electrically conductive first layer is configured between the support and the exclusion layer. A sensing system can include such biosensor.

Claims

1-40. -40. (canceled)

41. A biosensor comprising a biosensor unit with an electrode, wherein the electrode is rod-shaped, wherein the electrode further comprises a support with an electrically conductive first layer and an exclusion layer, wherein the electrically conductive first layer is configured between the support and the exclusion layer.

42. The biosensor according to claim 41, wherein the electrode comprises a needle shape with a needle shape tip, wherein the support comprises a material selected from the group consisting of stainless steel, a carbide, titanium, vanadium, tantalum, and tungsten metal, wherein the electrically conductive first layer comprises one or more of gold, silver, silver oxide, platinum, and carbon, and wherein the biosensor unit further comprises an enzyme attached to the electrode.

43. The biosensor according to claim 41, wherein the support comprises a material having compression strength of at least 20,000 kPa, especially wherein the support comprises a metal or metal alloy having a shear strength of at least 40 GPa.

44. The biosensor according to claim 41, wherein the support comprises one or more biocompatible materials.

45. The biosensor according to claim 41, wherein the electrically conductive first layer has a layer thickness in the range of 3 nm-100 μ

m and wherein the exclusion layer has a layer thickness in the range of 1 nm-50 μ

m.

46. The biosensor according to claim 41, wherein the exclusion layer is permeable for one or more of H₂O₂, O₂, and NO, or can facilitate electron transfer (ET) and wherein the exclusion layer is impermeable to one or more of ascorbate, 3,4-dihydroxyphenylacetic acid (DOPAC), dopamine, and uric acid, especially wherein the exclusion layer is permeable for H₂O₂.

47. The biosensor according to claim 41, wherein the exclusion layer comprises one or more of sulfonated tetrafluoroethylene based fluoropolymer-copolymer, N,N′

-Di-[(1-naphthyl)-N,N′

-diphenyl]-1,1′

-biphenyl)-4,4′

-diamine (NPD), and p-Phenylenediamine (PPD), especially wherein the exclusion layer comprises Nafion.

48. The biosensor according to claim 41, further comprising an electrically conductive second layer configured between the support and the electrically conductive first layer, especially wherein the electrically conductive second layer comprises copper.

49. The biosensor according to claim 41, wherein the electrode has a diameter of 4 mm or less, especially wherein the electrode has a diameter of 100 μ

m or less, more especially wherein the electrode has a diameter of 60 μ

m or less and wherein the electrode has a length selected from the range of 0.1 mm-15 mm or wherein the electrode has a length selected from the range of 0.1-200 μ

m.

50. The biosensor according to claim 42, wherein the enzyme comprises one or more of an Acetylcholinesterase, Choline oxidase, Alcohol oxidase, D-amino acid oxidase, L-amino acid oxidase, Ascorbate oxidase, Aspartate oxidase, Catalase, Cholesterol esterase, Cholesterol Oxidase, Galactose oxidase, Glucose oxidase, L-glutamate oxidase, GABase, Glutaminase, Glycerol kinase, Glycerol-3-phosphate oxidase, Glycerol-3-phosphate oxidase, Hexokinase, Horseradish peroxidase, Lactate oxidase, Pyruvate oxidase, and Lysine oxidase.

51. The biosensor according to claim 42, wherein the biosensor is configured as a first, second or third generation biosensor, the biosensor further comprising a protective layer configured to enclose the enzyme.

52. The biosensor according to claim 41, further comprising a reference electrode, wherein the reference electrode comprises an Ag/AgCl electrode.

53. The biosensor according to claim 41, further comprising a preamplifier in functional connection with the biosensor unit and functionally connected to said biosensor unit.

54. The biosensor according to claim 41, wherein the biosensor has outer dimensions equal to or smaller than 20 mm.

55. The biosensor according to claim 41, further comprising at least two electrodes, wherein the electrodes have a shortest distance of 80 μ

m or less, or wherein the electrodes have a shortest distance of at least 0.5 mm.

56. The biosensor according to claim 41, wherein the biosensor has at least six electrodes.

57. A sensing system comprising the biosensor according to claim 41, wherein the biosensor comprises at least two electrodes and the sensing system further comprises a source of electrical energy in functional connection with the at least two electrodes, and a detector configured to measure an electrical signal between at least two of the at least two electrodes.

58. A method of using the biosensor of claim 41 wherein the method includes sensing lactate in the scalp of a baby during birth with the biosensor or sensing system.

59. The method according to claim 58, for sensing neurotransmitters in tissue of an animal.

63. A method for making an electrode for a biosensor for sensing an endogenous analyte according to claim 41, including constructing a sensor surface on a biocompatible material used for invasive procedures in humans and/or animals, wherein the sensor surface at least comprises an electrically conductive first layer and an exclusion layer, wherein the electrically conductive first layer is configured between the biocompatible material and the exclusion layer.

64. A method of using the sensing system according to claim 57 wherein the method includes sensing lactate in the scalp of a baby during birth with sensing system.

60. A method comprising preparing a bio sensor for application of the biosensor in vivo, wherein preparing the biosensor comprises coating an electrochemical active material on a hard rigid material.

61. The method according to claim 60, the method comprising coating a gold coating on a stainless steel carrier material for measuring lactate in fetal scalp during labor.

62. The method according to claim 60, comprising coating a platinum coating on a tungsten needle for measuring neurotransmitters in brains of an animal.

65. The method according to claim 62, comprising applying copper as an electrically conductive second layer.

66. A method according to claim 61, comprising applying copper as an electrically conductive second layer for measuring lactate in fetal scalp during labor.

67. A method according to claim 61, comprising applying a platinum coating on a stainless steel carrier material for measuring lactate in fetal scalp during labor.