Sensor for blood component analysis

• US 7,785,271 B2
• Filed: 09/28/2004
• Issued: 08/31/2010
• Est. Priority Date: 10/02/2003
• Status: Expired due to Fees

• Current Assignee: PHC Holdings Corporation
• Original Assignee: Panasonic Corporation (Panasonic Holdings Corporation)
• Inventors: Fujiwara, Masaki, Ikeda, Shin
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): Smith; Fangemonique
• Application Number:
  US10/952,702
• Publication Number:
  US 20050123443A1
• Time in Patent Office: 2,163 Days
• Field of Search: 600/583, 600/300, 600/301, 604/19, 604/103.01, 604/406, 604/403, 204/409, 204/403.11, 606/194
• US Class Current: 600/583
• 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 5/14532 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 5/150213 Venting means
• CPC Class Codes: A61B 5/150343 Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes sampling from within body cavities A61B5/150015, A61B5/150045
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150442 Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin
• CPC Class Codes: A61B 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/150969 Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
• 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: C12Q 1/006 for glucose
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52

Abstract

A sensor for blood component analysis, which allows even a trace amount of blood to be led to an analysis portion reliably. The sensor for blood component analysis includes a substrate, a spacer, and a cover. The cover is disposed on the substrate with the spacer intervening between the cover and the substrate, whereby a space that serves as an analysis portion and a channel for leading blood to the analysis portion is formed inside the sensor. Through holes are formed in the substrate and the spacer, respectively, so that a common through hole through which a needle of a lancet can pass is formed when the spacer is disposed on the substrate. The through hole of the spacer communicates with the channel and a top of the through hole of the spacer is covered with the cover, whereby a lancing portion is formed by the common through hole and a portion of the cover covering the top of the through hole of the spacer. In use, the sensor is placed at a position where blood collection is to be performed, the portion of the cover covering the lancing portion is broken through with the needle of the lancet so that the needle is allowed to pass through the common through hole to puncture the position, and blood that has come out is guided by a downwardly protruding burr formed when the cover is broken through so that the blood is led to the channel and flows through the channel to be led to the analysis portion.

Claims

1. A collector and sensor for blood component analysis comprising:

a substrate having a through hole;

a spacer having a through hole;

a cover; and

a reagent layer,

the cover being disposed on the substrate with the spacer intervening between the cover and the substrate, whereby

a space between the substrate and the cover that communicates with the through hole of the spacer forms an analysis portion and a channel for leading a blood sample to the analysis portion inside the collector and sensor, with the reagent layer being disposed in the analysis portion, and

the cover being breakable by a needle or a lancet, whereby a downwardly protruding burr of the broken cover forms a path for the blood sample from a blood collection part to the channel to the analysis portion,

the through holes in the substrate and the spacer forming a common through hole through which the needle or an edge of the lancet and the burr of the broken cover can pass to the blood collection part when the spacer is disposed on the substrate that is placed over the blood collection part,

the through hole of the spacer communicating with the channel and a top of the through hole of the spacer being covered with the cover, whereby

a lancing portion is formed by the common through hole and a portion of the cover covering the top of the through hole of the spacer,

wherein the portion of the cover forming a part of the lancing portion is hydrophilic, and

wherein in use, the collector and sensor is placed at a position where blood collection is to be performed, the portion of the cover covering the lancing portion is broken through with the needle or the edge of the lancet so that the needle or the edge is allowed to pass through the common through hole to puncture the position, and the blood sample that has come out is guided by the burr formed when the cover is broken through so that the blood sample is led to the channel and flows through the channel to be led to the analysis portion.

2. The collector and sensor for blood component analysis according to claim 1, wherein a plurality of the channels and the analysis portions are provided with respect to one lancing portion.

3. The collector and sensor for blood component analysis according to claim 1, wherein a plurality of the lancing portions, the analysis portions, and the channels are present, and for each lancing portion, at least one channel and at least one analysis portion are formed.

4. The collector and sensor for blood component analysis according to claim 1, wherein an air vent hole is provided in a portion of the cover that corresponds to the channel.

5. The collector and sensor for blood component analysis according to claim 1, wherein the reagent layer is disposed on the substrate, a reagent in the reagent layer contains at least an oxidoreductase that reacts with an analyte, and an amount of the analyte is measured by causing a redox reaction between the oxidoreductase and the analyte contained in the blood sample and then measuring a degree to which the redox reaction has occurred.

6. The collector and sensor for blood component analysis according to claim 5, further comprising electrodes, wherein the electrodes are disposed in the analysis portion on the substrate so that a current generated by the redox reaction is measured by the electrodes.

7. The collector and sensor for blood component analysis according to claim 5, wherein the analyte is glucose in the blood sample, and the oxidoreductase is at least one of glucose oxidase and glucose dehydrogenase.

8. The collector and sensor for blood component analysis according to claim 5, wherein the reagent further comprises a mediator.

9. The collector and sensor for blood component analysis according to claim 1, wherein the spacer and the cover are separate components that are laminated with the substrate.