Biosensor Unified With Needle

• US 20080194988A1
• Filed: 03/01/2006
• Published: 08/14/2008
• Est. Priority Date: 03/02/2005
• Status: Abandoned Application

• Current Assignee: National Institute of Advanced Industrial Science and Technology (Government of Japan)
• Original Assignee: National Institute of Advanced Industrial Science and Technology (Government of Japan)
• Inventors: Nakamura, Hideaki, Gotoh, Masao, Karube, Isao
• Application Number:
  US11/885,352
• Publication Number:
  US 20080194988A1
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• CPC Class Codes: A61B 5/150175 Adjustment of penetration depth
• CPC Class Codes: A61B 5/150213 Venting means
• 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 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150717 manually removed
• CPC Class Codes: A61B 5/150748 Having means for aiding positioning of the piercing device at a location where the body is to be pierced means for aiding positioning of devices for bringing media into the body A61M5/427, locating blood vessels A61B5/489
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/15194 fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

There is provided a biosensor unified with a needle in which, since its constitution is simple, its assembling is easy in spite of having strength, collecting of body fluid sample can be conducted surely without waste, a puncturing needle is not polluted by a reagent layer, carrying is easy due to its simple package and hygiene can be maintained even after use. There is also provided a biosensor unified with a needle in which an assembling is easy without deteriorating its strength and collecting a body fluid sample can be surely conducted without waste where a puncturing needle is not polluted with a reagent layer.

A biosensor unified with a needle where a puncturing needle for collecting a body fluid by puncturing the skin of a person to be tested and a main body of a biosensor for conducting the analysis of the body fluid are constituted in a unified manner and the puncturing needle is constituted in such a manner that it penetrates by driving the main body of the biosensor in a vertical direction by an external driving means and punctures the skin. In a biosensor unified with a needle which is constituted in such a manner that a biosensor comprising electrically insulating substrate and cover, a spacer installed in a space sandwiched between them, an electrode and a reagent layer and a puncturing needle for penetrating the skin of a person to be tested and collecting the body fluid are unified, a biosensor unified with a needle which is characterized in that a cover part forming an opening for collecting the blood installed at the end of the longitudinal direction of a biosensor has one penetrating hole for a puncturing needle.

Claims

1. A biosensor unified with a needle where a puncturing needle for collecting a body fluid by puncturing a skin of a person to be tested and a main body of the biosensor for conducting an analysis of the body fluid are constituted in a unified manner and the puncturing needle is constituted in such a manner that it penetrates by driving the main body of the biosensor in a vertical direction by a driving means from outside and punctures the skin.

2. The biosensor unified with a needle according to claim 1,

wherein the biosensor is constituted from a spacer installed in a space sandwiched between an electrically insulating substrate and a cover, an electrode, a conveying path for a collected blood, an electrode reaction part, an opening for puncturing and collecting the blood, through which the puncturing needles penetrates to infuse the collected blood into the cover, and a substrate, which is equipped with a penetrating hole at a position opposite to the opening for puncturing and collecting the blood and a membrane (puncturing membrane) through which the needle can be penetrate, or a substrate equipped with a puncturing membrane only,

wherein the biosensor unified with a needle has a penetrating part for a puncturing needle where the puncturing needle can penetrate through the substrate and the cover,

wherein the biosensor unified with a needle has the electrode reaction part for an electrochemical measurement of the result of the reaction of a reagent in the electrode reaction part with a substance which is an object to be measured in the blood being resulted by such a manner that the blood flown out by puncturing of the skin of the person to be tested by the puncturing needle is introduced by capillary phenomenon from the opening for puncturing and collecting the blood to the conveying path for the collected blood and the electrode reaction part, and

wherein the biosensor unified with a needle is equipped with a folder for unifying the main body of the biosensor with the puncturing needle.

3. The biosensor according to claim 2, wherein the puncturing needle moving the penetrating part for the puncturing needle is arranged not to contact the reagent in the electrode reaction part.

4. The biosensor unified with a needle according to claim 2, wherein an opening for introduction of the sample and a pattern at an air outlet in the spacer sandwiched between the substrate and the cover are made in tapers.

5. The biosensor unified with a needle according to claim 2, wherein the puncturing membrane has a multi-layered structure comprising two or more layers having different materials.

6. The biosensor unified with a needle according to claim 2, wherein the puncturing membrane is a thin membrane having a thickness of not more than 100 μ

m.

7. The biosensor unified with a needle according to claim 2, wherein a shutter which opens and closes linking with the movement of puncturing needle is installed in the substrate of the biosensor.

8. The biosensor unified with a needle according to claim 2, wherein difference in level is made on the surrounding or the contour of the opening for puncturing and collecting the blood on a cover plane and the difference in level is used as an introducing guide for a sample.

9. The biosensor unified with a needle according to claim 2, wherein light of a visible light region is irradiated before puncturing from the opening for puncturing and collecting the blood to a puncturing position.

10. The biosensor unified with a needle according to claim 2, wherein a terminal on the insulating substrate is covered by the cover and the cover has a foldable folding line so as to expose an external terminal.

11. The biosensor unified with a needle according to claim 2, wherein a protective film, which can be adhered and detached, is placed on an outer surface of the insulating substrate.

12. The biosensor unified with a needle according to claim 2, further comprising a cap part for opening, the cap part having a cutting line on the boundary between a part of the insulating substrate containing no electrode and a part of the insulting substrate containing an electrode,

wherein an air outlet is opened when the part of the insulating substrate containing no electrode is cut off from the boundary.

13. The biosensor unified with a needle according to claim 2, wherein a package comprising a cap and a protective film can be re-adhered in the original state after using the biosensor.

14. The biosensor unified with a needle according to claim 1, wherein the puncturing needle is received in a housing for driving in a vertical direction and, the housing for the puncturing needle is equipped with such a mechanism that, after the puncturing needle driven by a driving means from outside penetrates the biosensor and punctures the skin of the person to be tested, it returns to the original position.

15. The biosensor unified with a needle according to claim 1, wherein a guide by which the action of the puncturing needle is made the same as the direction of the driving from outside is installed in a housing for the puncturing needle.

16. The biosensor unified with a needle according to claim 1, further comprising:

a mechanism for adjusting an inner pressure by which the pressure suddenly applied by the driving from outside in a housing for the puncturing needle in a tightly closed state is mitigated.

17. The biosensor unified with a needle according to claim 16, wherein the mechanism for mitigating the pressure is a valve for preventing a backflow.

18. The biosensor unified with a needle according to claim 1, wherein the inside of a housing for the puncturing needle which is in a tightly closed state after puncturing by the driving from outside becomes negative pressure and the negative pressure acts as a sucking force for introducing the collected blood to the conveying path.

19. The biosensor unified with a needle according to claim 1, wherein an air outlet necessary for introduction of the collected blood into the biosensor is equipped with a gas-permeable film.

20. The biosensor unified with a needle according to claim 1, wherein the puncturing needle has a photocatalytic action.

21. The biosensor unified with a needle according to claim 1, wherein an upper part of a housing for the puncturing needle is equipped with a cap for a simple package.

22. The biosensor unified with a needle according to claim 21, wherein the cap for the simple package is connected to the housing for the puncturing needle by a cramp.

23. The biosensor unified with a needle according to claim 1, wherein it is a cartridge type.

24. A cartridge for a biosensor unified with a needle according to claim 23, wherein it is a simple package type which can be re-packed.

25. A package for the cartridge of biosensor unified with a needle where plural cartridges for a biosensor unified with a needle mentioned in claim 23 are received.

26. A measuring apparatus for a biosensor unified with a needle, comprising:

the cartridge for the biosensor unified with a needle mentioned in claim 23;

an introducing part for the cartridge for the biosensor unified with a needles which slides and sets the cartridge for the biosensor unified with a needle;

a connector part which catches an electric signal at an electrode of the cartridge of the biosensor unified with a needle;

a measuring part which measures an electric value via the connector part;

an operation panel part for the measurement;

a display which displays the measured value at the measuring part;

a memory part which stores the measured value;

a driving part for the puncturing needle;

a trigger part for the driving part; and

a button for initiating a puncturing which initiates the puncturing by the puncturing needle.

27. The measuring apparatus for a biosensor unified with a needle according to claim 26, wherein a measuring method at the measuring part is a potential step chronoamperometry, a coulometry or a cyclic voltammetry.

28. The measuring apparatus for a biosensor unified with a needle according to claim 26, wherein the driving means from outside for the puncturing needle includes a mechanism such that, after it drives the puncturing needle, it returns the puncturing needle to an original position.

29. The measuring apparatus for a biosensor unified with a needle according to any of claims 26, further comprising:

a mechanism in which a depth of puncturing the skin of the person to be tested can be adjusted.

30. The measuring apparatus for a biosensor unified with a needle according to any of claims 26, wherein an illuminating mechanism works linking with pulling of a trigger of a puncturing driving of the measuring apparatus and the light irradiated from an introducing part for the collected blood illuminates a puncturing part of the person to be tested.

31. The measuring apparatus for a biosensor unified with a needle according to any of claims 26, wherein a measurement of hematocrit value is conducted by measuring a moving speed in the biosensor.

32. A method of using the measuring apparatus for the biosensor unified with a needle according to any of claims 26, wherein the cartridge for the biosensor unified with a needle is set in the measuring apparatus equipped with the driving means to the puncturing needle, a state where measurement is possible is resulted when pulling a trigger, a series of operations of puncturing, collecting the blood and measurement is automatically conducted when the front end of the measuring apparatus is touched to the person to be tested and the initiation switch for puncturing is pushed, and a result of the operations is displayed on the display of the measuring apparatus.

33. A biosensor unified with a needle where a biosensor where a biosensor, which includes an electrically insulating substrate and a cover, and a spacer, an electrode and a reagent layer, which are installed in a space sandwiched between the substrate and the cover, and a puncturing needle, which penetrates a skin of a person to be tested and collects a body fluid, are unified, wherein a cover part forming an opening for collecting the blood installed at a front end of a longitudinal direction of the biosensor has one penetrating hole for the puncturing needle.

34. The biosensor unified with a needle according to claim 33, wherein in the penetrating hole, a shutter, which opens and closes linking with a movement of a membrane through which the needle is penetrable (puncturing membrane) or a movement of the puncturing needle, is provided.

35. The biosensor unified with a needle according to claim 33, wherein an anti-slip device is installed at a lower surface of an end portion of the substrate forming an opening for collecting the blood.

36. The biosensor unified with a needle according to claim 33, wherein, when the puncturing needle passes the penetrating hole formed in the cover part of the biosensor, it is arranged not to contact the substrate.

37. The biosensor unified with a needle according to claim 33, wherein, when the puncturing needle penetrates, the needle is arranged at the angle of 20 to 90°

to the biosensor.

38. The biosensor unified with a needle according to claim 33, wherein the puncturing needle is fixed by a folder for the puncturing needle.

39. The biosensor unified with a needle according to any of claims 36, wherein the biosensor is fixed by a puncturing needle part-biosensor folder.

40. The biosensor unified with a needle according to claim 33, wherein the biosensor unfired with the needle is attached to a housing equipped with a cartridge for connecting to a measuring apparatus.

41. The biosensor unified with a needle according to claim 40, wherein the opening for collecting the blood at the front end of the biosensor unified with the needle projects from the housing.