Blood test apparatus

• US 7,927,290 B2
• Filed: 12/28/2006
• Issued: 04/19/2011
• Est. Priority Date: 01/05/2006
• Status: Expired due to Fees

• Current Assignee: PHC Holdings Corporation
• Original Assignee: Panasonic Corporation (Panasonic Holdings Corporation)
• Inventors: Amano, Yoshinori, Akiyama, Toshihiro, Fujiwara, Masaki
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): HENSON, DEVIN B
• Application Number:
  US12/159,904
• Publication Number:
  US 20090281455A1
• Time in Patent Office: 1,573 Days
• Field of Search: 600/573, 600/575, 600/576, 600/577, 600/578, 600/579, 600/583, 606/181
• US Class Current: 600/576
• 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 5/14535 for measuring haematocrit
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/150274 Manufacture or production processes or steps for blood sampling devices
• 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 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/150595 by snap-lock (i.e. based on axial displacement)
• CPC Class Codes: A61B 5/150641 comprising means to impede repositioning of protection sleeve from covering to uncovering position
• CPC Class Codes: A61B 5/150702 fully automatically removed, i.e. the removing does not require any action by the user
• CPC Class Codes: A61B 5/150717 manually removed
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• 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 5/1513 comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

A blood test apparatus wherein a blood collection needle and a blood sensor can be easily attached and detached so that a burden or pain of a patient can be relieved. More specifically speaking, a blood test apparatus wherein a holder, a lancet, a blood collection needle and a blood sensor are united together as a blood sampling cartridge that is detachably mounted to the apparatus body. When this blood sampling cartridge is attached, a plunger involved in the apparatus body holds the lancet and connectors involved in the apparatus body come into contact with the blood sensor. It is preferable that the contact points with the blood sensor of the individual connectors are located at intervals at the same angle centering on a definite point.

Claims

1. A blood test apparatus comprising:

a housing;

a measuring circuit accommodated in the housing;

two or more connectors electrically connected to the measuring circuit;

an attaching part formed in one side of the housing;

a plunger that moves back and forth in the housing;

a lancet, one end of the lancet is held by the plunger so as to allow the one end to be inserted into and removed from the plunger;

a blood collection needle attached to the other end of the lancet;

a holder that is held by the attaching part so as to allow the holder to be inserted into and removed from the attaching part and that allows the lancet to move inside the holder; and

a blood sensor that is attached to one end of the holder and that has two or more connection electrodes, wherein;

the lancet, the blood collection needle and the blood sensor are integrated with the holder to constitute a blood sampling cartridge that can be detachably inserted into and removed from the attaching part;

two or more connectors are arranged so as to be in contact with the connection electrodes of the blood sensor,

contact parts of the two or more connectors that contact with the connection electrodes of the blood sensor are arranged around a specific point and arranged at equiangular intervals centered on the specific point;

the specific point is a center of rotation with respect to an axis of an insertion direction for attaching the blood sampling cartridge to the attaching part;

one of the two or more connection electrodes includes a reference electrode; and

wherein the measuring circuit determines the positions of the two or more connectors relative to the two or more connection electrodes by determining which of the two or more connection electrodes includes the reference electrode and identifying which of the two or more connection electrodes contacts which of the two or more connectors.

2. The blood test apparatus according to claim 1, wherein an outer surface of the holder and an inner surface of the attaching part comprise a guide for inserting and removing the blood sampling cartridge.

3. The blood test apparatus according to claim 1, wherein a front part of the holder of the blood sampling cartridge with respect to an insertion direction is thinner than a rear part.

4. The blood test apparatus according to claim 1, wherein the blood collection needle and the lancet of the blood sampling cartridge are integrated.

5. The blood test apparatus according to claim 1, wherein the blood sampling cartridge is divisible into the integrated blood collection needle and lancet, and the holder to which the blood sensor is attached.

6. The blood test apparatus according to claim 1, wherein the blood sensor comprises:

a base plate;

a storage that is provided in the base plate and that samples blood from a skin punctured with the blood collection needle;

a supply channel, one end of which is connected to the storage, and, into which blood in the storage flows by capillary action;

a detector provided in the supply channel; and

an air hole that communicates with the supply channel.

7. The blood test apparatus according to claim 6, wherein:

the storage provided in the base plate comprises an opening in a surface that abuts the skin and a closing part in a surface opposite the surface that abuts the skin; and

the closing part is puncturable with the blood collection needle.

8. The blood test apparatus according to claim 7, wherein an area of the air hole is smaller than an area punctured with the blood collection needle.

9. The blood test apparatus according to claim 7, wherein a diameter of the air hole is 10 to 80 percent of a diameter of the blood collection needle.

10. The blood test apparatus according to claim 6, wherein the storage provided in the base plate comprises:

a first opening in a surface that abuts the skin; and

a second opening through which the blood collection needle can pass, in an surface opposite the surface that abuts the skin.

11. The blood test apparatus according to claim 10, wherein an area of the air hole is smaller than an area of the second opening.

12. The blood test apparatus according to claim 10, wherein an area of the second opening is larger than an area of the air hole and smaller than an area of the first opening.

13. The blood test apparatus according to claim 10, wherein the blood sampling cartridge comprises a cap that covers the blood collection needle of the lancet, and the cap passes through the storage.

14. The blood test apparatus according to claim 6, wherein at least part of the base plate is formed with a transparent member, so that blood inside the supply channel is visible.

15. The blood test apparatus according to claim 6, further comprising a second holder that covers a surface of the base plate, which surface abuts on the skin,

wherein the second holder comprises a round concave part of 4 to 15 mm in diameter on the surface that abuts the skin.

16. The blood test apparatus according to claim 6, wherein:

the detector comprises two or more detection electrodes configured to detect components of the sampled blood and a reagent, the two or more detection electrodes are connected to the two or more connection electrodes, respectively.

17. The blood test apparatus according to claim 16, wherein the reference electrode is electrically connected to one of the two or more connection electrodes via a conductor.

18. The blood test apparatus according to claim 16, wherein the reference electrode is electrically insulated from one of the two or more connection electrodes.

19. The blood test apparatus according to claim 16, wherein the reference electrode is identified by measuring resistance values between the reference electrode and each of the two or more connection electrodes.

20. The blood test apparatus according to claim 6, wherein a negative pressure can be supplied to the storage via the air hole.

21. The blood test apparatus according to claim 6, wherein a volume of the storage is one to twenty times a volume of the supply channel.

22. The blood test apparatus according to claim 6, wherein a volume of the storage is four to fifteen times a volume of the supply channel.

23. The blood test apparatus according to claim 6, wherein:

the base plate comprises;

a substrate that defines part of the storage;

a spacer that is provided on the substrate and that defines the supply channel and part of the storage; and

a cover that is provided on an upper surface of the spacer and in which the air hole is provided; and

a thickness of the substrate is greater than a thickness of the spacer.

24. The blood test apparatus according to claim 6, wherein a hydrophilicity treatment is applied to an inner surface of the supply channel, and a water repellent treatment is applied to a back surface of the base plate, wherein a front surface of the base plate abuts the skin.

25. The blood test apparatus according to claim 24, wherein an upper surface of the storage is less hydrophilic than an inner surface of the supply channel.

26. The blood test apparatus according to claim 24, wherein an upper surface of the storage is less water repellent than the back surface of the base plate.

27. The blood test apparatus according to claim 6, wherein a water repellent treatment is applied near the storage in a front surface of the base plate, which front surface abuts the skin.

28. The blood test apparatus according to claim 27, wherein a water repellent treatment is applied to an entire front surface of the base plate.

29. The blood test apparatus according to claim 27, wherein a water repellent treatment is applied to a back surface of the base plate, wherein the front surface abuts the skin.

30. The blood test apparatus according to claim 6, wherein an upper surface of the storage is less water repellent than a part near the storage on a front surface of the base plate, which front surface abuts the skin.

31. The blood test apparatus according to claim 6, wherein a projecting bank is provided near an opening of the storage on a front surface of the base plate, which front surface abuts the skin.

32. The blood test apparatus according to claim 31, wherein the bank is integrated with the base plate.

33. The blood test apparatus according to claim 31, wherein the bank is a separate member from the base plate.

34. The blood test apparatus according to claim 31, wherein:

the base plate comprises;

a substrate that defines part of the storage;

a spacer that is provided on the substrate and that defines the supply channel and part of the storage; and

a cover which is provided on an upper surface of the spacer, and in which the air hole is provided; and

the base plate is manufactured by;

preparing the substrate where the bank is formed near the opening of the storage;

stacking the spacer on a surface of the substrate where the bank is not formed; and

stacking the cover on the spacer.

35. The blood test apparatus according to claim 1, further comprising a negative pressure supplier that applies a negative pressure near part of the skin punctured with the blood collection needle.

36. The blood test apparatus according to claim 1, further comprising a display that displays a measurement result at the measuring circuit, or a transmitter that transmits the measurement result.

37. A blood sampling cartridge that is removably attachable to the blood test apparatus according to claim 1.