Body fluid sampling unit

• US 8,409,113 B2
• Filed: 10/21/2010
• Issued: 04/02/2013
• Est. Priority Date: 09/27/2006
• Status: Active Grant

• Current Assignee: Terumo Kabushiki Kaisha
• Original Assignee: Terumo Kabushiki Kaisha
• Inventors: Nakamura, Toshihisa, Nishiuchi, Daisuke
• Primary Examiner(s): DOUGHERTY, SEAN PATRICK
• Application Number:
  US12/909,233
• Publication Number:
  US 20110040209A1
• Time in Patent Office: 894 Days
• Field of Search: 600/583, 600/584, 606/4, 606/5, 606/181, 606/182, 606/185
• US Class Current: 600/584
• 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 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, the component measuring device being adapted to measure at least one of a quantity and a property of the predetermined component of the body fluid obtained by the body fluid sampling implement;

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.

2. The method as set forth in claim 1, 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.

3. The method as set forth in claim 1, 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.

4. The method as set forth in claim 3, wherein the body fluid sampling implement is mounted on the component measuring device by pushing the component measuring device towards the body fluid sampling implement, the pushing of the component measuring device 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.

5. The method as set forth in claim 1, wherein the interior of the container in which is located the body fluid sampling implement is covered by a removable membrane, and wherein the membrane is removed to expose the interior of the container before mounting the body fluid sampling implement on the component measuring device.

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

positioning a body fluid sampling implement on a component measuring device, the body fluid sampling implement being located inside a container in a gas-tight environment before the body fluid sampling implement is positioned on the component measuring device, the body fluid sampling implement being configured to obtain a sample of the body fluid and including a reagent containing part comprising a reagent adapted to interact with a predetermined component of the sample of the body fluid, the component measuring device being configured to be operated, when the body fluid sampling implement is positioned on the component measuring device, to measure at least one of a quantity and a property of the predetermined component of the sample of the body fluid obtained by the body fluid sampling implement;

puncturing a surface of the living body with a needle located inside the container by moving the needle relative to the container to produce the body fluid from which the body fluid sampling implement obtains the sample of the body fluid; and

introducing the sample of the body fluid to the reagent containing part of the body fluid sampling implement so that the reagent interacts with the predetermined component in the body fluid sample.

7. The method as set forth in claim 6, wherein the body fluid sampling implement is removed from inside the container before positioning the body fluid sampling implement on the component measuring device.

8. The method as set forth in claim 6, wherein the component measuring device is positioned on the body fluid sampling implement while the body fluid sampling implement is located inside the container.

9. The method as set forth in claim 6, wherein the body fluid sampling implement is positioned on the component measuring device by pushing the component measuring device towards the body fluid sampling implement while the body fluid sampling implement is located in the container.

10. The method as set forth in claim 9, wherein the pushing of the component measuring device towards the body fluid sampling implement causes a spring inside the container to accumulate a spring bias which is applied to the needle during the puncturing of the surface of the living body.

11. The method as set forth in claim 6, wherein the inside of the container in which is located the body fluid sampling implement is covered by a removable membrane, and wherein the membrane is removed to expose the body fluid sampling implement before mounting the body fluid sampling implement on the component measuring device.

12. The method as set forth in claim 6, wherein the container includes an opening, and the needle is mounted on a support section located inside the container, the support section being biased by a spring in a movement direction, the support section including an engaging piece which engages an inner periphery of the opening to maintain the support section inside the container at a position in which the needle is located inside the container, the method further comprising applying a force to the engaging piece to release the engaging piece from the inner periphery of the opening so that the spring urges the needle in the movement direction toward the surface of the living body.

13. The method as set forth in claim 6, further comprising an operating member mounted on the needle, the operating member including a needle containing section in which is positioned a distal end portion of the needle before the puncturing of the surface of the living body with the needle, the method further comprising removing the operating member from the needle before puncturing the surface of the living body with the needle so that the distal end portion of the needle is exposed.

14. The method as set forth in claim 6, wherein the body fluid sampling implement is removed from a proximal portion of the container before the puncturing of the surface of the living body with the needle.

15. The method as set forth in claim 6, wherein the needle is mounted on a support section located inside the container, the support section and needle moving together as a unit, the support section being biased by a spring in an axial direction of the needle, the support section including an engaging piece which engages an inner periphery of an opening in a distal end portion of a plate piece to prevent the support section and needle from moving in the axial direction, the plate piece also possessing a proximal end portion and an intermediate portion, the intermediate portion being between the distal end portion and the proximal end portion, the intermediate portion of the plate piece being supported on the container by a partition wall so that a downward force applied to the proximal end portion of the plate piece causes upward movement of the distal end portion of the plate piece, the method further comprising applying a downward force to the proximal end portion of the plate piece to cause the distal end portion of the plate piece to move upwardly so the engaging piece moves out of engagement with the inner periphery of the opening and moves in the axial direction toward the surface of the living body by virtue of a biasing force of the spring.

16. The method as set forth in claim 15, wherein the body fluid sampling implement possesses an outer periphery in contact with an inner periphery of the proximal end portion of the plate piece while the body fluid sampling implement is located inside the container and before positioning the body fluid sampling implement on the component measuring device, the contact of the outer periphery of the body fluid sampling implement with the inner periphery of the proximal end portion of the plate piece preventing a downward force applied to the proximal end portion of the plate piece from resulting in upward movement of the distal end portion of the plate piece.

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

moving a body fluid sampling implement from a housed position to an un-housed position, the body fluid sampling implement in the housed position being located inside a case such that an outer periphery of the body fluid sampling implement contacts an inner periphery of the case so that the contact between the case and the body fluid sampling implement prevents a force applied to the case from releasing an engagement between a part of the case and an engaging piece, the body fluid sampling implement in the un-housed position being outside the case so that the outer periphery of the body fluid sampling implement is not in contact with the inner periphery of the case, the body fluid sampling implement including a reagent containing part comprising a reagent adapted to interact with a predetermined component of a sample of the body fluid, the engaging piece being located inside the case and connected to a needle possessing a sharp distal end;

applying a force to the case after the body fluid sampling implement is moved to the un-housed position to cause the engaging piece to be disengaged from the case, and moving the needle when the engaging piece is disengaged from the case;

puncturing a surface of the living body with the sharp distal end of the moving needle to obtain the body fluid; and

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

18. The method as set forth in claim 17, further comprising mounting the body fluid sampling implement on a component measuring device, the component measuring device being configured to be operated, when the body fluid sampling implement is mounted on the component measuring device, to measure at least one of a quantity and a property of the predetermined component of the sample of the body fluid obtained by the body fluid sampling implement.

19. The method as set forth in claim 17, wherein moving of the engaging piece together with the needle comprises applying a biasing force of a spring to the engaging piece to axially move the engaging piece together with the needle in a distal direction when the engaging piece is disengaged from the case.

20. The method as set forth in claim 19, wherein the engaging piece engages a distal end portion of a plate piece which is supported on the case and the biasing force being a force applied to the plate piece, the force applied to the plate piece being a downward force applied to a proximal end portion of the plate piece, the downward force applied to the proximal end portion of the plate piece causing upward movement of the distal end portion of the plate piece which is engaged by the engaging piece, and the upward movement of the distal end portion of the plate piece causing the engaging piece to be disengaged from the distal end portion of the plate piece so that the engaging piece together with the needle is axially moved in the distal direction by the biasing force of the spring.