Structure and manufacturing method of disposable electrochemical sensor strip

• US 7,063,776 B2
• Filed: 06/17/2003
• Issued: 06/20/2006
• Est. Priority Date: 06/17/2003
• Status: Active Grant

• Current Assignee: Chun-Mu Huang
• Original Assignee: Chun-Mu Huang
• Inventors: Huang, Chun-Mu
• Primary Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US10/462,904
• Publication Number:
  US 20040256228A1
• Time in Patent Office: 1,099 Days
• Field of Search: 20440301-40315, 204/412, 204/434, 204/400, 204/416
• US Class Current: 204/403.14
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 33/5438 Electrodes

Abstract

A disposable electrochemical sensor strip is provided. The sensor strip includes an isolating sheet having at least a through hole, at least a conductive raw material mounted in the through hole, a metal film covered on the conductive raw material to form an electrode which comprises an electrode working surface for processing an electrode action, and an electrode connecting surface, at least a printed conductive film mounted on the isolating sheet and having a connecting terminal for being electrically connected to the electrode connecting surface, and a signal output terminal for outputting a measured signal produced by the electrode action.

Claims

1. A disposable electrochemical sensor strip, comprising:

an insulation sheet having at least a through hole;

at least a conductive raw material mounted in said through hole;

a metal film covered on said conductive raw material to form an electrode which comprises an electrode working surface for processing an electrode action, and an electrode connecting surface; and

at least a printed conductive film on said insulation sheet and having a connecting terminal for being electrically connected to said electrode connecting surface, and a signal output terminal for outputting a measured signal produced by said electrode action;

wherein said electrode forms an electrode area in said through hole whose area is an area of said working surface for processing said electrode action and transmitting said measured signal.

2. The sensor strip according to claim 1, wherein said conductive raw material is metallic so as to form a metallic electrode with said metal film.

3. The sensor strip according to claim 2, wherein said conductive raw material has a material selected from the group consisting of:

copper, brass, oxygen-free copper, bronze, phosphorized copper, nickel silver copper, and beryllium copper.

4. The sensor strip according to claim 1, further comprising a chemical reagent mounted on said electrode working surface for detecting an analyte through reacting with said analyte contained in a fluid sample so as to produce said measured signal which is then outputted through said signal output terminal.

5. The sensor strip according to claim 4, wherein said chemical reagent comprises an enzyme selected from the group consisting of glucose oxidase, uricase and cholesterol oxidase.

6. The sensor strip according to claim 1, wherein said printed conductive film is formed by printing a conductive paste on said insulation sheet so as to form said signal output terminal and said connecting terminal which is covered on said electrode connecting surface for electrically connecting with said electrode.

7. The sensor strip according to claim 6, wherein said conductive paste is a conductive adhesive containing a material selected from the group consisting of carbon, silver, copper, nickel, aluminum, gold, stainless steel and a combination mixture thereof.

8. The sensor strip according to claim 1 further comprising an insulating layer covered on said printed conductive film.

9. The sensor strip according to claim 1, wherein said metal film is made of a material selected from the group consisting of gold, platinum, rhodium, palladium, ruthenium, iridium, silver, copper, nickel, titanium, chromium, iron and aluminum.

10. The sensor strip according to claim 1, wherein said conductive raw material is one of a carbon-including conductive plastic compound, a metal-including conductive plastic compound, and a plastic material undergone with a conductive coating treatment.

11. The sensor strip according to claim 1, wherein said conductive raw material is coated with said metal film through a device selected from the group consisting of an electroplating device, an immersion plating device, a metal deposition device, a printing device and a metal spraying device.

12. The sensor strip according to claim 11, wherein said electroplating device holds an electroplating liquid containing a metal ion for coating said metal film on said conductive raw material.

13. The sensor strip according to claim 12, wherein said conductive raw material is pre-coated with said metal film to form said electrode which is then put in said through hole of said insulation sheet.

14. The sensor strip according to claim 12, wherein said conductive raw material is first put in said through hole of said insulation sheet and then coated with said metal film through said electroplating device so as to form said electrode in said through hole.

15. The sensor strip according to claim 1, wherein said metal film has a thickness ranged from 0.025˜

20 μ

m.

16. The sensor strip according to claim 1, wherein said through hole and said conductive raw material respectively have a shape selected from the group consisting of a circular form, a rectangular figure and an annular shape and are engaged with each other.

17. The sensor strip according to claim 1, wherein said insulation sheet has two said through holes whose bottoms are joined together to form an U-shaped recess for engaging with said conductive raw material having an U-shaped cross section, said metal film is coated on said conductive raw material in said U-shaped recess for forming said electrode with said electrode working surface in one leg of said U-shaped recess and said electrode connecting surface in another leg of said U-shaped recess, which are at the same side with respect to said insulation piece, so that said electrode working surface, said electrode connecting surface and said printed conductive film are formed at said same side of said insulation sheet.

18. A disposable electrochemical sensor strip, comprising:

an insulation piece having at least a through hole;

at least a conductive raw material mounted in said through hole; and

a metal film coated on said conductive raw material for forming an electrode which comprises an electrode working surface for processing an electrode action, and a signal output terminal for outputting a measured signal,

wherein said electrode forms an electrode area in said through hole whose area is an area of said working surface for processing said electrode action and transmitting said measured signal.

19. The sensor strip according to claim 18 further comprising a chemical reagent mounted on said electrode working surface for detecting an analyte contained in a fluid sample through reacting with said analyte so as to generate said measured signal which is then outputted through said signal output terminal.

20. The sensor strip according to claim 19, wherein said insulation piece comprises a tenon fixed in a notch of a measuring device for positioning said sensor on said measuring device.

21. The sensor strip according to claim 20, wherein said electrode comprises a signal output point for being connected to a signal connecting point of said measuring device, said insulation piece has a measuring recess located at a portion above said electrode for measuring a fluid sample, said measuring recess and said through hole are integrally formed, a meshed piece is mounted on said measuring recess for filtering an impurity in said fluid sample, said electrode and said chemical reagent are positioned under said meshed piece for forming a measuring region, a covering layer is covered on said meshed piece and connected to said insulation piece for avoiding said meshed piece from escaping from said measuring recess, and said covering layer comprises an opening for dropping therein said fluid sample.

22. The sensor strip according to claim 19, wherein said chemical reagent comprises an enzyme selected from the group consisting of glucose oxidase, unease and cholesterol oxidase.

23. The sensor strip according to claim 18, wherein said signal output terminal of said electrode has a rivet joint, said sensor strip further comprises a metallic thin strip mounted on said insulation piece and having an output terminal and an electrode connecting hole electrically retaining therein said rivet joint.

24. The sensor strip according to claim 18, wherein said metal film is made of a material selected from the group consisting of gold, platinum, rhodium, palladium, ruthenium, iridium, silver, copper, nickel, titanium, chromium, iron and aluminum.

25. The sensor strip according to claim 18, wherein said conductive raw material is coated with said metal film through a device selected from the group consisting of an electroplating device, an immersion plating device, a metal deposition device, a printing device and a metal spraying device.

26. The sensor strip according to claim 25, wherein said electroplating device holds an electroplating liquid containing a metal ion for coating said metal film on said conductive raw material.

27. The sensor strip according to claim 26, wherein said conductive raw material is pre-coated with said metal film to form said electrode which is then put in said through hole of said insulation sheet.

28. The sensor strip according to claim 18, wherein said conductive raw material is a cylindrical copper plate.

29. The sensor strip according to claim 28, wherein said cylindrical copper plate has a thickness ranged from 0.10 mm to 2.0 mm and a diameter ranged from 0.2 mm to 3.0 mm.

30. The sensor strip according to claim 18, wherein said insulation piece is formed through a device selected from the group consisting of an injection-molding device, a punch press device and a computerized drilling machine.

31. A disposable electrochemical sensor strip, comprising:

an insulation sheet having at least a recess; and

at least a metal electrode mounted in said recess and having an electrode working surface for processing an electrode action and a signal output terminal for outputting a measuring signal produced by said electrode action,

wherein said electrode forms an electrode area in said recess whose area is an area of said working surface for processing said electrode action and transmitting said measured signal.

32. The sensor strip according to claim 31 further comprising a metal film integrally formed with said metal electrode.

33. The sensor strip according to claim 32 further comprising a conductive strip which is integrally formed with said metal film and said metal electrode.

34. A disposable electrochemical sensor strip, comprising:

an insulation sheet having at least a first through hole;

a first conductive raw material mounted in said first through hole;

a first metal film covered on said first conductive raw material to form an electrode which comprises an electrode working surface for processing an electrode action, and an electrode connecting surface, wherein said electrode forms an electrode area in said through hole whose area is an area of said working surface for processing said electrode action; and

a first printed conductive film on said insulation sheet and having a connecting terminal for being electrically connected to said electrode connecting surface, and a signal output terminal for outputting a measured signal produced by said electrode actions and transmitting said measured signal.

35. The sensor strip according to claim 34 further comprising a second conductive raw material mounted in a second through hole of said insulation sheet, a second metal film coated on said second conductive raw material to form a second electrode which comprises a second electrode working surface which serves as a counter electrode and a second electrode connecting surface, and a second printed conductive film mounted on said insulation sheet and having a second connecting terminal which is electrically connected with said second electrode connecting surface, and a second signal output terminal.

36. The sensor strip according to claim 35 further comprising a third conductive raw material mounted in a third through hole of said insulation sheet, a third metal film coated on said third conductive raw material to form a third electrode which comprises a third electrode working surface which serves as a reference electrode and a third electrode connecting surface, and a third printed conductive film mounted on said insulation sheet and having a third connecting terminal which is electrically connected with said third electrode connecting surface, and a third signal output terminal.

37. The sensor strip according to claim 36, wherein said third metal film is a silver metal film which is immersion plated in a chemical solution, electroplated in a chemical solution or printed by an AgCl paste thereon through a printing device so that the silver metal film is modified into an Ag/AgCl reference electrode.

38. The sensor strip according to claim 36, wherein said insulation sheet has a flowing recess located at an edge portion above said electrodes for providing a fluid sample a space to flow therein, said flowing recess has a fluid inlet located at a side of said insulation sheet, said fluid inlet, said flowing recess and said through holes are integrally formed, a covering layer is covered on said flowing recess of said insulation sheet for forming a capillary channel and a measuring section by cooperating with said fluid inlet and said flowing recess to form a measure region, and said flowing recess further comprises a capillary vent for forming said capillary channel by cooperating with said fluid inlet.

39. The sensor strip according to claim 38, wherein said counter electrode and said working electrode form an electrode assembly and a space above said electrode assembly and under said measure region is provided to position therein a chemical reagent with an even thickness.

40. The sensor strip according to claim 38, wherein said insulation sheet has a protruding spacer for raising said covering layer and separating said fluid sample from an adhesive on said covering layer.

41. The sensor strip according to claim 38, wherein said counter electrode and said reference electrode are both printed electrodes, and said working electrode is a metal electrode mounted in one through hole selected from the group consisting of said first, second and third through holes of said insulation sheet.

42. The sensor strip according to claim 34, wherein said first electrode further comprises a modified layer immobilized thereon for forming a modified electrode.

43. A disposable electrochemical sensor strip, comprising:

an insulation piece having at least a through hole;

at least a conductive raw material mounted in said through hole; and

a metal film coated on said conductive raw material for forming an electrode which comprises an electrode working surface for processing an electrode action, and a signal output terminal for directly outputting a measured signal.

44. The sensor strip according to claim 43 further comprising a chemical reagent mounted on said electrode working surface for detecting an analyte contained in a fluid sample through reacting with said analyte so as to generate said measured signal which is then directly outputted through said signal output terminal.

45. The sensor strip according to claim 43, wherein said metal film is made of a material selected from the group consisting of gold, platinum, rhodium, palladium, ruthenium, iridium, silver, copper, nickel, titanium, chromium, iron and aluminum.

46. The sensor strip according to claim 43, wherein said conductive raw material is coated with said metal film through a device selected from the group consisting of an electroplating device, an immersion plating device, a metal deposition device, a printing device and a metal spraying device.

47. The sensor strip according to claim 46, wherein said electroplating device holds an electroplating liquid containing a metal ion for coating said metal film on said conductive raw material.

48. The sensor strip according to claim 43, wherein said conductive raw material is pre-coated with said metal film to form said electrode which is then put in said through hole of said insulation piece.

49. The sensor strip according to claim 43, wherein said conductive raw material is a cylindrical copper plate.

50. The sensor strip according to claim 49, wherein said cylindrical copper plate has a thickness ranged from 0.10 mm to 2.0 mm and a diameter ranged from 0.2 mm to 3.0 mm.

51. The sensor strip according to claim 43, wherein said insulation piece is formed through a device selected from the group consisting of an injection-molding device, a punch press device and a computerized drilling machine.

52. A disposable electrochemical sensor strip, comprising:

an insulation piece having at least a through hole;

at least a conductive raw material mounted in said through hole; and

a metal film coated on said conductive raw material for forming an electrode for directly outputting a measured signal.

53. The sensor strip according to claim 52 further comprising a chemical reagent mounted on said electrode working surface for detecting an analyte contained in a fluid sample through reacting with said analyte so as to generate said measured signal which is then outputted through said signal output terminal.

54. The sensor strip according to claim 52, wherein said metal film is made of a material selected from the group consisting of gold, platinum, rhodium, palladium, ruthenium, iridium, silver, copper, nickel, titanium, chromium, iron and aluminum.

55. The sensor strip according to claim 52, wherein said conductive raw material is coated with said metal film through a device selected from the group consisting of an electroplating device, an immersion plating device, a metal deposition device, a printing device and a metal spraying device.

56. The sensor strip according to claim 55, wherein said electroplating device holds an electroplating liquid containing a metal ion for coating said metal film on said conductive raw material.

57. The sensor strip according to claim 56, wherein said conductive raw material is pre-coated with said metal film to form said electrode which is then put in said through hole of said insulation piece.

58. The sensor strip according to claim 52, wherein said conductive raw material is a cylindrical copper plate.

59. The sensor strip according to claim 58, wherein said cylindrical copper plate has a thickness ranged from 0.10 mm to 2.0 mm and a diameter ranged from 0.2 mm to 3.0 mm.

60. The sensor strip according to claim 52, wherein said insulation piece is formed through a device selected from the group consisting of an injection-molding device, a punch press device and a computerized drilling machine.

61. A disposable electrochemical sensor strip, comprising:

an insulation piece having at least a through hole;

at least a conductive raw material mounted in said through hole; and

a metal film coated on said conductive raw material for forming an electrode which comprises an electrode working surface for processing an electrode action, and a signal output terminal for outputting a measured signal,

wherein said electrode and said insulation piece are simultaneously formed.

62. The sensor strip according to claim 61, wherein said electrode and said insulation piece are simultaneously formed through a molding device selected from the group consisting of an injection-molding device, a punch press device and a computerized drilling machine.

63. The sensor strip according to claim 61, wherein said metal film is made of a material selected from the group consisting of gold, platinum, rhodium, palladium, ruthenium, iridium, silver, copper, nickel, titanium, chromium, iron and aluminum.

64. The sensor strip according to claim 61, wherein said conductive raw material is coated with said metal film through a device selected from the group consisting of an electroplating device, an immersion plating device, a metal deposition device, a printing device and a metal spraying device.

65. The sensor strip according to claim 64, wherein said electroplating device holds an electroplating liquid containing a metal ion for coating said metal film on said conductive raw material.

66. The sensor strip according to claim 65, wherein said conductive raw material is pre-coated with said metal film to form said electrode which is then put in said through hole of said insulation piece.

67. The sensor strip according to claim 61, wherein said conductive raw material is a cylindrical copper plate.

68. The sensor strip according to claim 67, wherein said cylindrical copper plate has a thickness ranged from 0.10 mm to 2.0 mm and a diameter ranged from 0.2 mm to 3.0 mm.

70. A disposable electrochemical sensor strip, comprising:

an insulation piece having at least a through hole;

at least a conductive raw material mounted in said through hole; and

a metal film coated on said conductive raw material for forming an electrode which comprises an electrode working surface for processing an electrode action, and a signal output terminal for outputting a measured signal,

wherein said sensor strip comprises said insulation piece being the only one insulation piece therein.

69. The sensor strip according to claim 70, wherein said insulation piece is formed through a device selected from the group consisting of an injection-molding device, a punch press device and a computerized drilling machine.

71. The sensor strip according to claim 70 further comprising a chemical reagent mounted on said electrode working surface for detecting an analyte contained in a fluid sample through reacting with said analyte so as to generate said measured signal which is then outputted through said signal output terminal.

72. The sensor strip according to claim 70, wherein said metal film is made of a material selected from the group consisting of gold, platinum, rhodium, palladium, ruthenium, iridium, silver, copper, nickel, titanium, chromium, iron and aluminum.

73. The sensor strip according to claim 70, wherein said conductive raw material is coated with said metal film through a device selected from the group consisting of an electroplating device, an immersion plating device, a metal deposition device, a printing device and a metal spraying device.

74. The sensor strip according to claim 73, wherein said electroplating device holds an electroplating liquid containing a metal ion for coating said metal film on said conductive raw material.

75. The sensor strip according to claim 74, wherein said conductive raw material is pre-coated with said metal film to form said electrode which is then put in said through hole of said insulation piece.

76. The sensor strip according to claim 70, wherein said conductive raw material is a cylindrical copper plate.

77. The sensor strip according to claim 76, wherein said cylindrical copper plate has a thickness ranged from 0.10 mm to 2.0 mm and a diameter ranged from 0.2 mm to 3.0 mm.

78. The sensor strip according to claim 70, wherein said insulation piece is formed through a device selected from the group consisting of an injection-molding device, a punch press device and a computerized drilling machine.