NEEDLE INTEGRATED BIOSENSOR

• US 20090124876A1
• Filed: 06/27/2006
• Published: 05/14/2009
• Est. Priority Date: 06/27/2005
• 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:
  US11/994,010
• Publication Number:
  US 20090124876A1
• Time in Patent Office: Days
• US Class Current: 600/345
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• 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 5/150022 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 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• 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 5/150435 Specific design of proximal end
• 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 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• 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 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• 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 a needle integrated biosensor, including: a biosensor including at least two electrodes, and a puncture needle to collect a body fluid by piercing a skin of a person to be tested, the biosensor and the puncture needle being integrated, wherein the puncture needle is able to be kept hygienic without the need of a protective cover or the like for the puncture needle.

There is a needle integrated biosensor, including: a biosensor including at least two electrodes, and a puncture needle to collect a body fluid by piercing a skin of a person to be tested, the biosensor and the puncture needle being integrated, wherein a soft material is attached to the front end of the puncture needle so that the front end of the puncture needle is protected.

Claims

1. A needle integrated biosensor, comprising:

a biosensor including at least two electrodes, and

a puncture needle to collect a body fluid by piercing a skin of a person to be tested,

the biosensor and the puncture needle being integrated, wherein

a soft material is attached to a front end of the puncture needle.

2. The needle integrated biosensor according to claim 1, wherein

the soft material is sterilized.

3. The needle integrated biosensor according to claim 1, wherein

the soft material to which an antibiotic action is endowed is used.

4. The needle integrated biosensor according to claim 1, wherein

a space between two substrates and a puncture needle support for fixing the puncture needle to a substrate is tightly closed by a shrinkable material at a rear part of the puncture needle,

an inner area of the biosensor is kept in negative pressure, and

the puncture needle pierces both of the soft material and the skin to collect blood by means of suction and measure the detected component.

16. The needle integrated biosensor according to claim 1, wherein

the soft material is a gel-like material, an elastic material or a foamed material.

17. The needle integrated biosensor according to claim 16, wherein

the elastic material is silicone rubber.

18. The needle integrated biosensor according to claim 4, wherein

the shrinkable material is natural rubber.

20. A measuring apparatus for a needle integrated biosensor, comprising:

the needle integrated biosensor according to claim 1,

an introducing part for the needle integrated biosensor where the needle integrated biosensor is inserted and set,

a connector part for catching electric signal at an electrode of the needle integrated biosensor,

a measuring part for measuring an electric value via the connector part,

an operation panel part for the measurement,

a display part for displaying a measured value at the measuring part,

a memory part for storing the measured value,

a driving part for driving a puncture needle, and

a pierce starting button for starting the piercing by a drive trigger part and the puncture needle.

24. The measuring apparatus for a needle integrated biosensor according to claim 20, comprising:

at least one of voice guidance mechanism and a voice recognition mechanism, a control mechanism for measured data by incorporation of radio clock, a communication mechanism of the measured data to medical organizations and a charging mechanism.

5. A needle integrated biosensor, comprising:

a biosensor including electrode and spacer and a puncture needle to collect a body fluid by piercing a skin of a person to be tested aligned in the biosensor are integrated via a puncture needle support in a space between two electrically insulating substrates, wherein

a piercing and blood-collecting opening at the front end of the puncture needle is tightly closed by a puncturable soft material while, in the rear end of the puncture needle, space between two substrates and the puncture needle support is tightly closed by a shrinkable material and the inner area of the biosensor is kept in a negative pressure, and

the blood is collected by means of suction and the components to be detected are measured when the puncture needle breaks through both of the soft material and the skin by means of a drive from outside.

6. The needle integrated biosensor according to claim 5, wherein

the puncture needle is placed in parallel to a long-axial direction of the electrode in the biosensor.

7. The needle integrated biosensor according to claim 5, wherein

if the puncture needle support is pulled in the direction opposite to the piercing direction immediately after the piercing,

the shrinkable material placed among the rear end of the puncture needle, the biosensor substrate and the cover is extended so that the inner part of the biosensor is made in more negative pressure.

21. A measuring apparatus for the needle integrated biosensor according to claim 5, comprising:

a piercing drive, and

an extension mechanism of a shrinkable material connecting the puncture needle and the biosensor.

25. The needle integrated biosensor according to claim 5, wherein

the soft material is a gel-like material, an elastic material or a foamed material.

26. The needle integrated biosensor according to claim 25, wherein

the elastic material is silicone rubber.

27. The needle integrated biosensor according to claim 5, wherein

the shrinkable material is natural rubber.

28. A measuring apparatus for a needle integrated biosensor, comprising:

the needle integrated biosensor according to claim 5,

an introducing part for the needle integrated biosensor where the needle integrated biosensor is inserted and set,

a connector part for catching electric signal at an electrode of the needle integrated biosensor,

a measuring part for measuring an electric value via the connector part,

an operation panel part for the measurement,

a display part for displaying a measured value at the measuring part,

a memory part for storing the measured value,

a driving part for driving a puncture needle, and

a pierce starting button for starting the piercing by a drive trigger part and the puncture needle.

29. The measuring apparatus for a needle integrated biosensor according to claim 28, comprising:

at least one of voice guidance mechanism and a voice recognition mechanism, a control mechanism for measured data by incorporation of radio clock, a communication mechanism of the measured data to medical organizations and a charging mechanism.

8. A needle integrated biosensor comprising:

a biosensor including an electrode and a spacer in a space sandwiched between two sheets of electrically insulating substrate, and

a puncture needle which is provided in the biosensor to collect a body fluid by piercing a skin of a person to be tested,

the biosensor and the puncture needle being constituted in a integrated manner via a support for the puncture needle, wherein

each of the substrates includes a cutting part by which separation of substrate part where no electrode is formed,

a piercing and blood-collecting opening at the front end of the puncture needle is tightly closed by a puncturable soft material, cutting part of the two substrates are covered by a shrinkable material provided at the rear end of the puncture needle, and the space between the two substrates and the puncture needle is tightly closed so that the inner area of the biosensor is tightly closed, and

after the puncture needle simultaneously breaks through both of the soft material and the skin by being driven from outside, a part of the substrates is separated at the cutting part and, the volume of the inner area of the biosensor is increased to make the inner area in negative pressure to collect the blood by means of suction and measure the components to be detected.

9. The needle integrated biosensor according to claim 8, wherein

the cutting part is constituted from an easily cuttable bonding part.

10. The needle integrated biosensor according to claim 9, wherein

the easily cuttable binding part is formed as at least one bonding part on a line between the substrates, or is constituted by a groove formed in a depth which does not penetrate the substrate at least on one side of the substrate.

11. The needle integrated biosensor according to claim 10, wherein

a linear bonding part where the central area is constricted is used.

12. The needle integrated biosensor according to claim 10, wherein

a V-shaped groove is used.

13. The needle integrated biosensor according to claim 8, wherein

the puncture needle is provided in a crossing manner in a long-axial direction of the electrode formed on one of the substrates.

14. The needle integrated biosensor according to claim 8, wherein

the puncture needle is provided in a crossing manner at a right angle to the long-axial direction of the electrode formed on one of the substrates.

15. The needle integrated biosensor according to claim 8, wherein

the biosensor has a bilaterally asymmetric shape where the puncture needle is a central line.

19. The needle integrated biosensor according to claim 8, wherein

if a puncture needle support is pulled immediately after piercing in a direction opposite to the piercing direction,

the cutting part provided in the biosensor substrate is cut off, and volume of the inner part of the biosensor is increased so that the inner part is made in a negative pressure.

22. A measuring apparatus for the needle integrated biosensor according to claim 8, comprising:

a piercing drive, and

a cutting part for a biosensor substrate and a cutting off mechanism.

23. A measuring apparatus for the needle integrated biosensor according to claim 8, comprising:

a mechanism to recognize the bilaterally asymmetric structure where the puncture needle for the needle integrated biosensor is a central line at a projected part of a terminal for the measurement.

30. The needle integrated biosensor according to claim 8, wherein

the soft material is a gel-like material, an elastic material or a foamed material.

31. The needle integrated biosensor according to claim 30, wherein

the elastic material is silicone rubber.

32. The needle integrated biosensor according to claim 8, wherein

the shrinkable material is natural rubber.

33. A measuring apparatus for a needle integrated biosensor, comprising:

the needle integrated biosensor according to claim 8,

an introducing part for the needle integrated biosensor where the needle integrated biosensor is inserted and set,

a connector part for catching electric signal at an electrode of the needle integrated biosensor,

a measuring part for measuring an electric value via the connector part,

an operation panel part for the measurement,

a display part for displaying a measured value at the measuring part,

a memory part for storing the measured value,

a driving part for driving a puncture needle, and

a pierce starting button for starting the piercing by a drive trigger part and the puncture needle.

34. The measuring apparatus for a needle integrated biosensor according to claim 33, comprising:

at least one of voice guidance mechanism and a voice recognition mechanism, a control mechanism for measured data by incorporation of radio clock, a communication mechanism of the measured data to medical organizations and a charging mechanism.