SENSOR FOR BLOOD COMPONENT ANALYSIS

• US 20100286562A1
• Filed: 07/22/2010
• Published: 11/11/2010
• Est. Priority Date: 10/02/2003
• Status: Abandoned Application

• Current Assignee: Panasonic Corporation (Panasonic Holdings Corporation)
• Original Assignee: Panasonic Corporation (Panasonic Holdings Corporation)
• Inventors: FUJIWARA, Masaki, IKEDA, Shin
• Application Number:
  US12/841,770
• Publication Number:
  US 20100286562A1
• Time in Patent Office: Days
• 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

1-9. -9. (canceled)

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

a substantially rectangular substrate having a through hole;

a spacer having a through hole;

a cover including a through hole as an air vent;

a reagent layer; and

a lancing portion, wherein the cover is disposed on the substrate, and the spacer is disposed between the cover and the substrate, whereby the through hole of the spacer, the through hole of the substrate, and the cover form a space,

the space includes an analysis portion and a channel for leading a blood sample from a blood collector portion to the analysis portion,

the reagent layer is disposed in the analysis portion,

the thorough hole as an air vent of the cover communicates with the space to serve as an air vent hole,

the through hole in the substrate and the through hole in the spacer form a common through hole,

the cover covers a top of the through hole of the spacer,

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

the through hole of the substrate, the through hole of the spacer, and the through hole as an air vent of the cover are located closer to one end in a longitudinal direction with respect to the center of the substrate, whereby the lancing portion, the analysis portion, and the air vent hole are located closer to one end in the longitudinal direction with respect to the center of the collector and sensor.

11. The collector and sensor according to claim 10, wherein the lancing portion, the analysis portion, and the air vent hole are disposed in this order from the center to the end of the sensor.

12. The collector and sensor according to claim 10, wherein the lancing portion, the analysis portion, and the air vent hole are disposed in this order from the center to the end of the sensor, and a plurality of the analysis portions are disposed in series with respect to the longitudinal direction of the substrate between the lancing portion and the air vent hole.

13. The collector and sensor according to claim 10, wherein a plurality of the analysis portions and a plurality of the air vent holes are disposed radially with respect to the one lancing portion, and each of the analysis portions is disposed between the lancing portion and each of the air vent holes.

14. The collector and sensor according to claim 10, wherein a plurality of the analysis portions and a plurality of the air vent holes are disposed so as to surround a plurality of the lancing portions, and each of the analysis portions is disposed between each of the lancing portions and each of the air vent holes.

15. The collector and sensor according to claim 10, wherein the lancing portion and a plurality of the analysis portions disposed in parallel with respect to the longitudinal direction of the substrate are disposed in this order from the center to the end of the sensor, and the channel branches, so that the lancing portion and a plurality of the analysis portions communicate with each other.

16. The collector and sensor according to claim 10, wherein the cover can be broken through with a needle or an end of a lancet, and the blood sample from the blood collector portion is led to the channel by a downwardly protruding burr of the broken cover, whereby the blood sample flows through the channel to be led to the analysis portion.

17. The collector and sensor according to claim 10, wherein the cover is made of the same material as that of the substrate or the spacer.

18. The collector and sensor according to claim 10, wherein the cover is made of one or more materials selected from the group consisting of polyethylene terephthalate (PET), polycarbonate (PC), polyimide (PI), polyethylene (PE), polypropylene (PP), polystyrene (PS), polyvinyl chloride (PVC), polyoxymethylene (POM), monomer”

cast nylon (MC), polybutylene terephthalate (PBT), polymethyl methacrylate (PMMA), an ABS resin (ABS), and glass.

19. The collector and sensor according to claim 10, wherein at least the lancing portion of the cover is hydrophilic.

20. The collector and sensor according to claim 10, wherein a reagent containing an oxidoreductase that reacts with an analyte is disposed on the analysis portion, and an amount of the analyte is measured by causing a redox reaction between the oxidoreductase and the analyte contained in the blood and then measuring the degree to which the redox reaction has occurred.

21. The collector and sensor according to claim 20, wherein electrodes further are disposed on the analysis portion so that a current generated by the redox reaction is measured by the electrodes.

22. The collector and sensor according to claim 20, wherein the analyte is glucose in the blood, and the oxidoreductase is at least one of glucose oxidase and glucose dehydrogenase.

23. The collector and sensor according to claim 20, wherein the reagent further comprises a mediator.

24. A method of using the collector and sensor for blood component analysis according to claim 10, comprising:

placing the collector and sensor on a finger so that the substrate side faces the finger;

breaking through the portion of the cover covering the top of the through hole of the spacer with a needle or an end of a lancet to injure the finger by a downwardly protruding burr of the broken cover;

leading blood that has come out from the finger from the collector portion to the channel; and

allowing the blood sample to flow through the channel to be led to the analysis portion.