Integrated Sensor and Lancet Device and Method for Collecting Body Fluid Using the Same

• US 20100036281A1
• Filed: 11/30/2006
• Published: 02/11/2010
• Est. Priority Date: 12/01/2005
• Status: Abandoned Application

• Current Assignee: ARKRAY, Inc
• Original Assignee: ARKRAY, Inc
• Inventors: Doi, Shigeru
• Application Number:
  US12/085,900
• Publication Number:
  US 20100036281A1
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150213 Venting means
• 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 5/150404 Specific design of proximal end
• 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 5/150717 manually removed
• CPC Class Codes: A61B 5/151 Devices specially adapted for taking samples of capillary blood, e.g. by lancets , needles or blades
• 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 5/15123 comprising magnets or solenoids
• 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

The present invention relates to a sensor/lancet integrated device 1 including a lancet including a needle part 14 for puncturing skin, and a sensor including a reagent part 17. The lancet is integrally molded with the needle part 14. The device 1 preferably further includes a capillary 15 for supplying to the reagent part 17. Preferably, the needle part 14 is formed to a hollow form, and has the interior communicated to an introduction port. The needle part 14 may be formed projecting from a location different from the introduction port.

Claims

1. A sensor/lancet integrated device comprising a lancet including a needle part for puncturing skin, and a sensor including a reagent part;

wherein

the lancet is integrally molded with the needle part.

2. The sensor/lancet integrated device according to claim 1, wherein the sensor further includes an electrode integrally incorporated in the lancet.

3. The sensor/lancet integrated device according to claim 1, wherein

the sensor and the lancet are formed as separate bodies;

and

the sensor is held in an internal space formed in the lancet to be integrated to each other.

4. The lancet/lancet integrated device according to claim 1, wherein

the sensor has a mode in which a cover is joined with respect to a substrate;

the lancet includes a joint for attaching to the sensor; and

the joint is fixed to the sensor so as to sandwich the substrate.

5. The lancet/lancet integrated device according to claim 4, wherein the joint is fixed to the sensor so as to further sandwich the cover.

6. The lancet/lancet integrated device according to claim 5, further comprising:

a capillary for supplying body fluid to the reagent part;

wherein

the needle part is projected from a location different from an introduction port of the body fluid in the capillary.

7. The sensor/lancet integrated device according to claim 1, wherein

the reagent part includes a color producing agent and is formed in an internal space formed in the lancet;

and

at least one part of the lancet is formed transparent to measure a color of the color producing agent.

8. The sensor/lancet integrated device according to claim 1, wherein the needle part is formed hollow.

9. The lancet/lancet integrated device according to claim 8, further comprising:

a capillary for supplying body fluid to the reagent part;

wherein

the interior of the needle part is communicated to the interior of the capillary.

10. The sensor/lancet integrated device according to claim 8, wherein the interior of the needle part is filled with resin before use.

11. The lancet/lancet integrated device according to claim 9, further comprising:

a capillary for supplying body fluid to the reagent part;

wherein

the lancet includes a groove for defining the capillary.

12. A sensor/lancet integrated device comprising a lancet including a needle part for puncturing skin, and a sensor including an introduction port for introducing body fluid;

wherein

the needle part is formed projecting from a location different from the introduction port.

13. The sensor/lancet integrated device according to claim 12, wherein the needle part is integrally molded to a component of the sensor.

14. The sensor/lancet integrated device according to claim 12, further comprising:

a cover to be joined to the sensor;

wherein

the cover includes a groove for defining a capillary for introducing the body fluid.

15. The sensor/lancet integrated device according to claim 12, wherein the sensor further includes an electrode.

16. The sensor/lancet integrated device according to claim 12, wherein

the sensor and the lancet are formed as separate bodies;

and

the sensor is held in an internal space formed in the lancet to be integrated to each other.

17. The sensor/lancet integrated device according to claim 12, wherein

the reagent part includes a color producing agent and is formed in an internal space formed in the lancet;

and

at least one part of the lancet is formed transparent to measure a color of the color producing agent.

18. A sensor-run set integrated device comprising a lancet including a needle part for puncturing skin, and a sensor including a reagent part;

wherein

the sensor has a mode in which a cover is joined with respect to a substrate; and

the needle part is fixed between the substrate and the cover.

19. A sensor/lancet integrated device comprising a lancet including a needle part for puncturing skin, and a sensor including a reagent part;

wherein

the lancet includes a joint for fixing to the sensor; and

the needle part is integrated to the joint.

20. The lancet/lancet integrated device according to claim 19, wherein

the sensor has a mode in which a cover is joined with respect to a substrate;

and

the joint is attached to the sensor so as to sandwich the substrate.

21. The lancet/lancet integrated device according to claim 20, wherein the joint is fixed to the sensor so as to further sandwich the cover.

22. A body fluid collecting method using a sensor/lancet integrated device including a lancet integrally molded with a needle part formed to a hollow form, and a sensor with a reagent part;

the method comprising;

a first step of moving the needle part to a position where a tip of the needle part contacts skin, and obtaining the position where the tip of the needle part contacts the skin;

a second step of puncturing the needle part to the skin and incising the skin;

a third step of removing the needle part from the skin; and

a fourth step of contacting the tip of the needle part to the body fluid bled from the skin based on a result in the first step.

23. The body fluid collecting method according to claim 22, wherein the fourth step is performed by again moving the needle part after once being moved to a position where the tip of the needle part is completely away from the skin, and contacting the needle part to the body fluid bled from the skin.

24. The body fluid collecting method according to claim 22, wherein the fourth step is performed by stopping the movement of the needle part immediately after removing the needle part from the skin.

25. The body fluid collecting method according to claim 22, wherein at least one of the second step or the third step is performed with a negative pressure applied to the skin.

26. A body fluid collecting method using a sensor/lancet integrated device including a lancet integrally molded with a needle part formed to a hollow form, and a sensor with a reagent part;

the method comprising;

a first step of puncturing the needle part to skin and incising the skin; and

a second step of aspirating the body fluid to an interior of the needle part by a capillary force generated in the interior of the needle part with the needle part punctured in the skin.

27. A body fluid collecting method using a sensor/lancet integrated device including a sensor with an introduction port for introducing body fluid, and a lancet with a needle part formed projecting from a location different from the introduction port;

the method comprising;

a first step of puncturing the needle part to skin and incising the skin;

a second step of removing the needle part from the skin;

a third step of rotating the sensor/lancet integrated device; and

a fourth step of contacting the introduction port to the body fluid bled from the skin.

28. The body fluid collecting method according to claim 27, further comprising a fifth step, performed before the first step, of moving the needle part to a position where a tip of the needle part contacts the skin, and obtaining the position where the tip of the needle part contacts the skin.