Extracting kit, extracting device, and extracting method

• US 20050177037A1
• Filed: 01/07/2005
• Published: 08/11/2005
• Est. Priority Date: 01/09/2004
• Status: Abandoned Application

• Current Assignee: Sysmex Corporation
• Original Assignee: Sysmex Corporation
• Inventors: Sato, Toshiyuki, Maekawa, Yasunori, Okada, Seiki, Sawa, Kennichi, Hagino, Kei, Nagaoka, Kanako
• Application Number:
  US11/031,722
• Publication Number:
  US 20050177037A1
• Time in Patent Office: Days
• US Class Current: 600/347
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/681 Wristwatch-type devices
• CPC Class Codes: A61M 2037/0007 having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• CPC Class Codes: A61N 1/306 Arrangements where at least part of the apparatus is introduced into the body

Abstract

An extracting kits for extracting analyte through the skin of a living body are disclosed that comprises an inserting device comprising needles for forming a plurality of extraction holes in the skin through the stratum corneum but not reaching the subcutaneous tissue and an extracting device for extracting the analyte into a liquid supplied into the extraction holes by supplying the liquid into the plurality of extraction holes. An extracting device and extracting method are also described.

Claims

1. An extracting kit for extracting analyte through the skin of a living body, the extracting kit comprising:

an inserting device comprising needles for forming a plurality of extraction holes in the skin through the stratum corneum but not reaching the subcutaneous tissue; and

an extracting device for extracting the analyte into a liquid supplied into the extraction holes by supplying the liquid into the plurality of extraction holes.

2. The extraction kit of claim 1, wherein the extracting device further comprises:

a liquid holder for retaining the liquid to supply into the extraction holes;

a sensor placed in contact with the liquid retained in the liquid holder; and

a power source for applying a voltage for migrating the analyte extracted into the liquid supplied to the extraction holes toward the sensor.

3. The extracting kit of claim 2, wherein the power source applies to the living body a voltage of a magnitude such that a current does not actually flow to the stratum corneum of the skin.

4. The extracting kit of claim 1, wherein the length of the part of the needle inserted into the skin is greater than approximately 20 μ

m but less than approximately 1,000 μ

m.

5. The extracting kit of claim 1, wherein the inserting device comprises the plurality of needles and a holder capable of holding the plurality of needles.

6. The extracting kit of claim 1, wherein the extracting device comprises, a power source, negative and positive electrodes connected to the power source, and a collection medium provided in contact with at least one or another of the negative electrode and positive electrode so as to collect the extracted analyte.

7. The extraction kit of claim 1, further comprising:

a marker for specifying the position on the skin at which the extraction hole is formed.

8. The extracting kit of claim 1, wherein the extraction hole in the skin passes through the stratum corneum and reaches corium but does not reach the subcutaneous tissue.

9. The extracting kit of claim 1, wherein the analyte extracted into the liquid comprises glucose and the extracting device comprises

an input unit for inputting an initial blood sugar value;

a power source for transferring the glucose out of the extraction holes;

a detecting unit for detecting signals based on the transferred glucose; and

a control unit for calculating a blood sugar value from the signal detected by the detecting unit;

wherein the control unit calculates glucose concentration from the signal detected by the detecting unit, and calculates the blood sugar value based on the glucose concentration and the initial blood sugar value input by the input unit.

10. The extracting kit of claim 9, wherein the control unit calculates the blood sugar value based on the initial blood sugar value, initial glucose concentration, and the glucose concentration.

11. The extracting kit of claim 9, wherein the control unit determines an initial glucose concentration per unit of current based on initial current value and initial glucose concentration, determines a glucose concentration per unit of current based on assay time current value and the glucose concentration, and calculates the blood sugar value based on the initial glucose concentration per unit of current and the glucose concentration per unit of current and the initial blood sugar value.

12. The extracting kit of claim 9, wherein the control unit determines an initial glucose concentration per unit of conductivity based on initial voltage value and initial glucose concentration, determines a glucose concentration per unit of conductivity based on assay time voltage value and the glucose concentration, and calculates the blood sugar value based on the initial glucose concentration per unit of conductivity and the glucose concentration per unit of conductivity and the initial blood sugar value.

13. An extraction device for extracting analyte through the skin of a living body, the extraction device comprising:

a power source for applying a voltage for transferring analyte extracted into extraction holes formed on the skin out of the extraction holes; and

a checking means for checking the state of extraction hole formation.

14. The extraction device of claim 13, wherein the checking means checks the state of extraction hole formation based on a current value or a voltage value when the power source applies an electric field to the living body.

15. The extracting device of claim 14, wherein the checking means monitors the current value when the power source applies an electric field to the living body, and determines the extraction hole has not been adequately formed when the current value is less than a predetermined value.

16. The extracting device of claim 14, wherein the checking means monitors the voltage value when the power source applies an electric field to the living body, and determines the extraction hole has not been adequately formed when the voltage value is less than a predetermined value.

17. The extracting device of claim 13, further comprising:

an outputting means for outputting a message urging extraction hole formation when the checking means determines that the extraction hole has not been adequately formed.

18. An extracting method for extracting analyte through the skin of a living body, the method comprising:

an extraction hole formation step of forming a plurality of extraction holes in the skin through the stratum corneum but not reaching the subcutaneous tissue; and

an extraction step of extracting the analyte into a liquid supplied to the extraction holes by supplying the liquid into the plurality of extraction holes.

19. The extracting method of claim 18, further comprising a transferring step of transferring the analyte extracted into the liquid supplied to the extraction holes out of the extraction holes by applying a voltage to the liquid supplied to the extraction holes.

20. The extracting method of claim 18, wherein, in the transferring step, the voltage applied to the living body is of a magnitude such that a current does not actually flow to the stratum corneum of the skin.

21. The extracting method of claim 18, wherein the extraction hole is formed using a needle, the part of which that is inserted into the skin has a length that is greater than approximately 20 μ

m but less than approximately 1,000 μ

m.

22. The extracting method of claim 18, further comprising:

a step of placing an extraction device for extraction of the analyte on the skin, and

a collection step of collecting the analyte transferred out of the extraction holes in the transferring step.

23. The extracting method of claim 18, further comprising:

a step of placing a marker on the skin to specify the position on the skin at which the extraction hole is formed.

24. An extracting method for extracting analyte through the skin of a living body, the method comprising:

an extraction hole formation step for forming a plurality of extraction holes in the skin for the extraction of analyte;

a checking step for checking the state of extraction hole formation; and

a transferring step of transferring the analyte extracted into the extraction holes out of the extraction holes if the extraction holes are judged to be formed sufficiently in the checking step.

25. The extracting method of claim 24, wherein the checking step comprises an electric field application step for applying an electric field to the living body, and a current checking step for checking the state of extraction hole formation based on current value or a voltage value in the electric field application step.

26. The extracting method of claim 25, wherein, in the current checking step, the extraction hole formation is determined to be inadequate when the current value is less than a predetermined value in the electric field application step.

27. The extracting method of claim 25, wherein, in the voltage checking step, the extraction hole formation is determined to be inadequate when the voltage value exceeds a predetermined value in the electric field application step.

28. The extracting method of claim 24, further comprising:

an output step for outputting a message urging extraction hole formation when it is determined the extraction hole formation is inadequate in the checking step.

29. An extracting kit for extracting analyte through the skin of a living body, the extracting kit comprising:

an inserting device comprising a needle for forming an extraction hole in the skin through the stratum corneum but not reaching the subcutaneous tissue; and

an extracting device for extracting analyte outside of the extraction hole and placed on the skin where the extraction hole is formed.

30. An extracting method for extracting analyte through the skin of a living body, the method comprising:

an extraction hole formation step of forming an extraction hole in the skin through the stratum corneum but not reaching the subcutaneous tissue; and

an extraction step of extracting analyte outside of the extraction hole.