Body fluid sampling unit

• US 20080077096A1
• Filed: 09/27/2007
• Published: 03/27/2008
• Est. Priority Date: 09/27/2006
• Status: Active Grant

• Current Assignee: Terumo Kabushiki Kaisha
• Original Assignee: Terumo Kabushiki Kaisha
• Inventors: Nishiuchi, Daisuke, Nakamura, Toshihisa
• Granted Patent: US 7,867,175 B2
• Time in Patent Office: Days
• US Class Current: 604/318
• 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 5/150259 Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• 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 5/150549 Protectors removed by rotational movement, e.g. torsion or screwing
• CPC Class Codes: A61B 5/150618 Integrally moulded protectors, e.g. protectors simultaneously moulded together with a further component, e.g. a hub, of the piercing element
• CPC Class Codes: A61B 5/150717 manually removed
• 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 5/15144 comprising driving means, e.g. a spring, for retracting the piercing unit into the housing

Abstract

A body fluid sampling unit includes a puncture device including a needle having a sharp needle point and a drive mechanism for operating the needle to puncture a living body surface with the needle point, a tip including an introducing section for introducing a body fluid flowing out from a puncture portion of the living body surface punctured with the needle point, a test paper for detecting a predetermined component in the body fluid, and a tip body mounted to a component measuring device for measuring the quantity and/or property of the predetermined component detected by the test paper; and a case including a mechanism containing section for containing the puncture mechanism so that the needle point of the puncture mechanism can be moved by the drive means, and a sampling implement containing section for containing the body fluid sampling implement so that the tip can be taken out.

Claims

1. A body fluid sampling unit comprising:

a container having an interior;

a needle positioned in the interior of the container, the needle possessing a sharp needle point at a distal end of the needle;

at least one spring positioned in the interior of the container;

the at least one spring being operatively engageable with the needle and being configured to accumulate a spring bias to be applied to the needle to move the needle in a puncturing direction to puncture a living body surface with the needle point;

a body fluid sampling implement removably positioned in the interior of the container;

the body fluid sampling implement comprising;

an introducing section for conveying body fluid flowing out from a puncture portion of the living body surface punctured with the needle point;

a reagent containing part positioned adjacent the introducing section to receive the body fluid conveyed by the introducing section, the reagent containing part comprising a reagent adapted to interact with a predetermined component in the body fluid; and

a mounted section configured to be mounted to a component measuring device for measuring the quantity and/or property of the predetermined component.

2. The body fluid sampling unit as set forth in claim 1, wherein the interior of the container comprises a sampling implement containing section in which is positioned the body fluid sampling implement, the sampling implement containing section being covered by a removable membrane member which seals the sampling implement containing section in an air-tight manner.

3. The body fluid sampling unit as set forth in claim 1, wherein the container comprises an inner tube movably positioned within an outer tube, the body fluid sampling implement being positioned inside the inner tube, the outer tube comprising first and second openings, the inner tube comprising a pawl engaging the first opening, the body fluid sampling implement being configured to be mounted to the component measuring device while the body fluid sampling implement is contained in the sampling implement containing section by pushing the component measuring device towards the body fluid sampling implement to engage the body fluid sampling implement with the component measuring device, said pushing causing the inner tube to move within the outer tube to cause the pawl to be released from the first opening and to engage the second opening.

4. The body fluid sampling unit as set forth in claim 1, wherein the body fluid sampling implement is positioned at a distal end portion of the interior of the container, the body fluid sampling implement being located distal of the needle.

5. A body fluid sampling unit comprising:

a puncture mechanism comprising a needle possessing a sharp needle point at a distal end of the needle, and drive means for operating the needle to puncture a living body surface with the needle point;

a body fluid sampling implement comprising an introducing section for introducing a body fluid flowing out from a puncture portion of the living body surface punctured with the needle point, a detecting section for detecting a predetermined component in the body fluid introduced through the introducing section, and a mounted section configured to be mounted to a component measuring device for measuring the quantity and/or property of the predetermined component detected by the detecting section; and

a container comprising a mechanism containing section containing the puncture mechanism so that the needle point of the puncture mechanism is movable by the drive means, and a sampling implement containing section containing the body fluid sampling implement in a manner allowing the body fluid sampling implement to be removed from the sampling implement containing section.

6. The body fluid sampling unit as set forth in claim 5, wherein the body fluid sampling unit is discarded after one time use in measuring the quantity and/or property of the predetermined component.

7. The body fluid sampling unit as set forth in claim 5, wherein the sampling implement containing section extends from the mechanism containing section, and the sampling implement containing section and the mechanism containing section are disposed coaxially.

8. The body fluid sampling unit as set forth in claim 7, wherein the sampling implement containing section is located on a side opposite to the direction of the needle point of the needle relative to the mechanism containing section.

9. The body fluid sampling unit as set forth in claim 5, wherein the drive means moves the needle in a puncturing direction to puncture the living body surface with the needle point, the body fluid sampling implement being removable from the sampling implement containing section in the puncturing direction of the needle.

10. The body fluid sampling unit as set forth in claim 5, wherein the body fluid sampling implement is used by being removed from the sampling implement containing section and then being mounted to the component measuring device.

11. The body fluid sampling unit as set forth in claim 5, wherein the body fluid sampling implement is configured to be mounted to the component measuring device while the body fluid sampling implement is contained in the sampling implement containing section, and is thereafter removed from the sampling implement containing section while mounted to the component measuring device by spacing the container away from the component measuring device.

12. The body fluid sampling unit as set forth in claim 11,

wherein the body fluid sampling implement is tentatively fixed to the sampling implement containing section, and

a force with which the sampling implement containing section fixes the body fluid sampling implement is smaller than a force of connection between the body fluid sampling implement and the component measuring device.

13. The body fluid sampling unit as set forth in claim 5, wherein the puncture mechanism is put into a state of being prepared to perform an operation of puncturing the living body surface by removal of the body fluid sampling implement from the sampling implement containing section.

14. The body fluid sampling unit as set forth in claim 5, wherein the drive means includes a support section at which the needle is supported and a biasing section adapted to bias the support section, and wherein a biasing force to bias the support section is accumulated in the biasing section by pressing the body fluid sampling implement against the component measuring device when mounting the body fluid sampling implement to the component measuring device.

15. The body fluid sampling unit as set forth in claim 14, wherein

the mechanism containing section includes an outer tube;

the sampling implement containing section includes an inner tube slidably positioned inside the outer tube for slidably moving in a longitudinal direction of the outer tube, the inner tube being connected to the puncture mechanism;

the body fluid sampling implement is mounted to the component measuring device by pushing the component measuring device towards the body fluid sampling implement; and

during pushing of the component measuring device towards the body fluid sampling implement, the inner tube is pushed together with the body fluid sampling implement to slidably move inside the outer tube, whereby a biasing force of the biasing section is accumulated.

16. The body fluid sampling unit as set forth in claim 5, wherein the drive means includes a support section at which the needle is supported, a biasing section for biasing the support section, and an operating member for displacing the support section so as to bias the biasing section.

17. The body fluid sampling unit as set forth in claim 16, wherein the operating member is a cap covering the needle point of the needle and maintaining a sterile state of the needle point.

18. The body fluid sampling unit as set forth in claim 5,

wherein the mounted section possesses a bottomed tube shape;

the introducing section protrudes in a tubular form from a bottom part of the mounted section; and

the detecting section is disposed at the bottom part.

19. The body fluid sampling unit as set forth in claim 5, wherein the detecting section comprises a test paper carrying a reagent adapted to perform a color reaction with the predetermined component in the body fluid.

20. The body fluid sampling unit as set forth in claim 5, wherein the detecting section comprises at least two electrodes, and a reagent coated part coated with a reagent adapted to react with the predetermined component in the body fluid to thereby generate a current between the electrodes.

21. The body fluid sampling unit as set forth in claim 5, wherein the sampling implement containing section has an opening through which the body fluid sampling implement is movable into and out of the sampling implement containing section, the sampling implement containing section comprising a seal member sealing the opening in a gas-tight manner while the body fluid sampling implement is contained in the sampling implement containing section.

22. A method of obtaining a body fluid sample from a living body and using the body fluid sample comprising:

removing a body fluid sampling implement from an interior of a container, the body fluid sampling implement comprising a reagent containing part comprising a reagent adapted to interact with a predetermined component in the body fluid, the interior of the container also containing a needle possessing a sharp needle point at a distal end of the needle;

mounting the body fluid sampling implement on a component measuring device which is adapted to measure a quantity and/or property of a predetermined component of the body fluid;

the body fluid sampling implement being removed from the interior of the container either before mounting the body fluid sampling implement on the component measuring device or after mounting the body fluid sampling implement on the component measuring device;

puncturing a surface of the living body with the needle by moving the needle relative to the container to produce a body fluid sample; and

introducing to the reagent containing part of the body fluid sampling implement the body fluid sample obtained by puncturing the surface of the living body with the needle so that the reagent interacts with the predetermined component in the body fluid sample.

23. The method as set forth in claim 22, wherein the body fluid sampling implement is removed from the interior of the container before mounting the body fluid sampling implement on the component measuring device, the body fluid sampling implement being mounted on the component measuring device after removing the body fluid sampling implement from the interior of the container.

24. The method as set forth in claim 22, wherein the body fluid sampling implement is mounted on the component measuring device as the body fluid sampling implement is in the interior of the container, the body fluid sampling implement being removed from the interior of the container after the body fluid sampling implement is mounted on the component measuring device.

25. The method as set forth in claim 24, wherein the body fluid sampling implement is mounted on the component measuring device by pushing the component measuring device into the body fluid sampling implement, the pushing of the component measuring device into the body fluid sampling implement causing a spring in the interior of the container to accumulate a spring bias which is applied to the needle during the puncturing of the surface of the living body.