BIOSENSOR

• US 20090093695A1
• Filed: 06/27/2006
• Published: 04/09/2009
• 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:
  US11/993,911
• Publication Number:
  US 20090093695A1
• Time in Patent Office: Days
• US Class Current: 600/347
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• 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 5/14865 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 5/150282 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 5/15113 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
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52

Abstract

There is provided a biosensor (which is integrated with a needle) with a high precision where an assembling is easy and reproducibility of the prepared biosensor (integrated with a needle) is good.

There is provided with a biosensor comprising:

• • two sheets of electrically insulating substrates connected by a connecting part, and
  • an electrode and a spacer formed on one of or both of the two sheets of electrically insulating substrates, wherein
  • the two sheets of the electrically insulating substrates are folded along the connecting part, and
  • the electrode and the spacer are positioned between the electrically insulating substrates.

In this biosensor (integrated with a needle), a biosensor (integrated with a needle) is able to be easily prepared by folding two sheets of electrically insulating substrates which are connected by a connecting part and, therefore, it achieves excellent effects that the product is able to be easily manufactured without such a troublesome step where each biosensor material is correctly layered and that the biosensor (integrated with a needle) manufactured as such has a good reproducibility and a high precision.

Claims

1. A biosensor comprising:

two sheets of electrically insulating substrates connected by a connecting part, and

an electrode and a spacer formed on one of or both of the two sheets of electrically insulating substrates, wherein

the two sheets of the electrically insulating substrates are folded along the connecting part, and

the electrode and the spacer are positioned between the electrically insulating substrates.

2. The biosensor according to claim 1, wherein

the connecting part is provided by preparing broken lines or forming a hinge to the electrically insulating substrate.

3. The biosensor according to claim 1, wherein

a pole insertion hole through which a pole used for positioning the two electrically insulating substrates is provided at sites where the two electrically insulating substrates confront upon forming the biosensor.

4. The biosensor according to claim 3, wherein

a pole is penetrated through the pole insertion hole to position the two electrically insulating substrates.

5. A needle integrated biosensor with a puncture needle for penetrating a skin of a person to be tested to collect a body fluid is included together with the electrode and the spacer in the biosensor according to claim 1, wherein

the electrode, the spacer and the puncture needle are positioned between the electrically insulating substrates.

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

the puncture needle is movable in the biosensor by a drive from outside.

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

the needle integrated biosensor mentioned in 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 electric value via the connector part,

an operation panel part for 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.

12. The needle integrated biosensor according to claim 11, further comprising:

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

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

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

7. 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 an integrated manner via a support for the puncture needle, wherein

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

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

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

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

the needle integrated biosensor mentioned in claim 7,

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 electric value via the connector part,

an operation panel part for 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.

17. The needle integrated biosensor according to claim 16, further comprising:

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

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

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

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 an integrated manner via a support for the puncture needle, wherein

the electrodes are provided in a face-to-face manner to form facing electrodes.

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

the puncture needle is provided by crossing at a right angle to the long-axial direction of the electrode in the biosensor.

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

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

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

the needle integrated biosensor mentioned in 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 electric value via the connector part,

an operation panel part for 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.

20. The needle integrated biosensor according to claim 19, further comprising:

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

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

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

14. A method for manufacturing a biosensor, comprising the steps of:

inserting a pole for a folding guide into a pole insertion hole of a biosensor,

folding the biosensor together with the folding guide,

inserting the pole into another pole insertion hole of the biosensor, and

storing the pole in a pole receiving pole of the biosensor.