Electrode strip and sensor strip and manufacture method thereof and system thereof

• US 9,880,128 B2
• Filed: 03/06/2015
• Issued: 01/30/2018
• Est. Priority Date: 07/20/2012
• Status: Active Grant

• Current Assignee: Apex Biotechnology Corporation
• Original Assignee: Apex Biotechnology Corporation
• Inventors: Huang, Ying-Che, Huang, Lan-Hsiang, Chu, Ching-Yuan
• Primary Examiner(s): Noguerola, Alexander S
• Application Number:
  US14/640,193
• Publication Number:
  US 20150276671A1
• Time in Patent Office: 1,061 Days
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• 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: 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: G01N 27/3273 Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875
• CPC Class Codes: G01N 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771
• CPC Class Codes: G01N 27/4166 measuring a particular property of an electrolyte
• CPC Class Codes: G01N 33/80 involving blood groups or blood types or red blood cells white blood cells G01N33/56972
• CPC Class Codes: Y10T 156/10 Methods of surface bonding and/or assembly therefor
• CPC Class Codes: Y10T 156/1052 with cutting, punching, tearing or severing
• CPC Class Codes: Y10T 156/1057 Subsequent to assembly of laminae

Abstract

The present disclosure relates to an electrode strip, a sensor strip, a system thereof and a manufacturing method thereof. The sensor strip includes a first reactive film, a second reactive film and a vent hole. The first reactive film includes a substrate, a first electrode layer and a first insulation layer. The first end of the first insulation layer is concaved to a first depth to form a first reactive area. The second reactive film includes a second electrode layer and a second insulation layer. The first end of the second insulation layer is concaved to a second depth to form a second reactive area. The vent hole penetrates the second insulation layer, the second electrode layer and the first insulation layer so as to connect the first reactive area and the second reactive area.

Claims

1. A method for manufacturing a sensor strip, comprising the steps of:

providing a first reactive film and a second reactive film, wherein the first reactive film includes a first reactive area, and the second reactive film includes a second reactive area;

disposing the first reactive film on the second reactive film; and

forming a vent hole penetrating the first reactive film and connecting the first reactive area and the second reactive area,

wherein the step of providing the first reactive film includes the following steps;

providing a substrate;

disposing a first electrode layer on the substrate;

forming a first insulation layer on the first electrode layer wherein a first end of the first insulation layer is concaved to form the first reactive area within a first depth; and

coating or printing a first reaction layer in the first reactive area, and

wherein the step of providing the second reactive film includes the following steps;

disposing a second electrode layer on the first insulation layer;

forming a second insulation layer on the second electrode layer wherein a first end of the second insulation layer is concaved to form the second reactive area with a second depth;

coating or printing a second reaction layer in the second reactive area; and

exposing an electrode of the second electrode layer adjacent to a second end of the second insulation layer.

2. The method for manufacturing a sensor strip according to claim 1, wherein the step of forming the first insulation layer further includes a step of exposing an electrode of the first electrode layer adjacent to a second end of the first insulation layer, and

wherein the step of forming the first insulation layer includes coating or printing.

3. The method for manufacturing a sensor strip according to claim 1, wherein the step of forming the vent hole is fabricated by a laser ablation method or a punch press method.

4. A method for manufacturing an electrode strip, comprising the steps:

providing a first substrate;

disposing a first electrode set on the first substrate;

forming a first insulation layer on the first electrode set, wherein the first insulation layer includes a first opening;

disposing a second substrate on the first insulation layer, wherein the second substrate includes a sampling opening and a connecting hole;

disposing a second electrode set on the second substrate, wherein the second electrode set uncovers the connecting hole; and

forming a second insulation layer on the second electrode set, wherein the second insulation layer includes a second opening, wherein the connecting hole vertically connects the first opening and the second opening.

5. The method for manufacturing an electrode strip according to claim 4, wherein forming the first insulation layer and the second insulation layer includes coating or printing.

6. The method for manufacturing an electrode strip according to claim 4, further comprising the steps of:

coating or printing a first reaction layer in the first opening;

coating or printing a second reaction layer in the second opening; and

disposing a cover on the second insulation layer, wherein the cover includes a through hole, and the through hole connects the connecting hole.

7. A measurement system with hematocrit correction, comprising:

an electrode strip, comprising;

a first substrate;

a first electrode set disposed directly on the first substrate;

a first insulation layer including a first opening and disposed on the first electrode set;

a second substrate disposed on the first insulation layer and including a sampling opening and a connecting hole;

a second electrode set disposed directly on the second substrate and uncovering the connecting hole; and

a second insulation layer including a second opening, wherein the connecting hole vertically connects the first opening and the second opening;

wherein the first electrode set, the first insulation layer, the second substrate, the second electrode set and the second insulation layer are disposed on one side of the first substrate;

wherein the first electrode set is configured to measure an analyte concentration, and the second electrode set is configured to measure a hematocrit concentration; and

a sensor configured to electrically connect with the electrode strip, and the sensor including;

a power source configured to simultaneously provide a direct current (DC) signal and an alternating current (AC) signal, wherein the DC signal is transmitted to either the first electrode set, and the AC signal is transmitted to either the second electrode set;

a detector configured to detect a first reactive value in response to the analyte concentration and a second reactive value in response to the hematocrit concentration; and

a microprocessor configured to calculate a hematocrit-corrected analyte concentration in response to the first reactive value and the second reactive value.

8. The measurement system with hematocrit correction according to claim 7, wherein the electrode strip further comprises a cover disposed on the second insulation layer,

wherein the cover includes a through hole connecting with the connecting hole,

wherein the second opening is located between the cover and the second substrate to form a second reactive area, and the first opening is located between the first substrate and the second substrate to form a first reactive area,

wherein the cover, the first electrode set, the first insulation layer, the second substrate, the second electrode set and the second insulation layer are disposed on the same side of the first substrate.

9. The measurement system with hematocrit correction according to claim 8, wherein the first reactive area includes a first depth, the second reactive area includes a second depth, the sampling opening includes a third depth and wherein either the first depth or the second depth is longer than the third depth, the first reactive area and the second reactive area accommodate samples from the same source, the first depth and the second depth are configured to separate the sample of the first reactive area from the sample of the second reactive area.

10. The measurement system with hematocrit correction according to claim 9, wherein an inside diameter of the first opening where the first reactive area is located is equal to an inside diameter of the sampling opening, and an inside diameter of the second opening where the second reactive area is located is equal to an inside diameter of the sampling opening.

11. The measurement system with hematocrit correction according to claim 7, wherein an inside diameter of the first opening is larger or smaller than an inside diameter of the sampling opening, and an inside diameter of the second opening is larger or smaller than an inside diameter of the sampling opening.

12. The measurement system with hematocrit correction according to claim 7, wherein an end of the second substrate, where the sampling opening is formed, is a hydrophobic surface and wherein the first insulation layer exposes a connection of the first electrode set away from the first opening, the second insulation layer exposes a connection of the second electrode set away from the second opening, and the connection of the first electrode set does not overlap with the connection of the second electrode set.

13. The measurement system with hematocrit correction according to claim 7, wherein the second substrate includes an awl-shaped end where the sampling opening is located, and the sampling opening is located at a tip area of the awl-like shaped end.

14. The measurement system with hematocrit correction according to claim 7, wherein the sampling opening is disposed at a corner of the second substrate, a lengthwise axis of the first opening and a lengthwise axis of the first insulation layer intersect to form an included angle.

15. A measurement system with hematocrit correction, comprising:

a sensor strip, comprising;

a first reactive film including a substrate, a first electrode layer disposed directly on the substrate, and a first insulation layer including a first end and disposed on the first electrode layer, wherein the first end is concaved to form a first reactive area with a first depth;

a second reactive film including a second electrode layer disposed directly on the first insulation layer, and a second insulation layer including a first end and disposed on the second electrode layer, wherein the first end of the second insulation layer is concaved to form a second reactive area with a second depth; and

a vent hole penetrating the second insulation layer, the second electrode layer and the first insulation layer and connecting the first reactive area and the second reactive area;

wherein the first electrode layer, the first insulation layer, the second electrode layer and the second insulation layer are disposed on one side of the substrate;

wherein the first electrode layer is configured to measure an analyte concentration, and the second electrode layer is configured to measure a hematocrit concentration; and

a sensor configured to electrically connect with the sensor strip and the sensor including;

a power source configured to simultaneously provide a direct current (DC) signal and an alternating current (AC) signal, wherein the DC signal is transmitted to the first electrode layer, and the AC signal is transmitted to the second electrode layer;

a detector configured to detect a first reactive value in response to the analyte concentration and a second reactive value in response to the hematocrit concentration; and

a microprocessor configured to calculate a hematocrit-corrected analyte concentration in response to the first reactive value and the second reactive value.

16. The measurement system with hematocrit correction according to claim 15, wherein the first end of the first insulation layer adjacent to the first electrode layer is concaved to form the first reactive area, and a sampling opening with a third depth is concaved and formed next to the first reactive area, and wherein either the first depth or the second depth is longer than the third depth and wherein the first reactive area and the second reactive area accommodate samples from an identical source and the first depth and the second depth are configured to separate the sample of the first reactive area from the sample of the second reactive area.

17. The measurement system with hematocrit correction according to claim 16, wherein an inside diameter of the first reactive area is larger or smaller than an inside diameter of the sampling opening and wherein an inside diameter of the second reactive area is larger or smaller than an insider diameter of the sampling opening and wherein the first end of the first insulation layer away from the substrate is a hydrophobic surface and wherein the first insulation layer further includes a second end, the first electrode layer includes at least one electrode, and the first insulation layer exposes the at least one electrode adjacent to the second end.