Source: http://www.google.com/patents/US20090281455?ie=ISO-8859-1&dq=Frischling
Timestamp: 2014-08-23 10:14:00
Document Index: 467633418

Matched Legal Cases: ['art. 3', 'art.\n5', 'art.\n15', 'art 48', 'art 49', 'art 49', 'art 49', 'art 49', 'art 49', 'art 49', 'art 49', 'art 49', 'art 49', 'art 49', 'art 49', 'art 49', 'art 49']

Patent US20090281455 - Blood test apparatus - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign in<nobr>Advanced Patent Search</nobr>PatentsA 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...http://www.google.com/patents/US20090281455?utm_source=gb-gplus-sharePatent US20090281455 - Blood test apparatusAdvanced Patent SearchPublication numberUS20090281455 A1Publication typeApplicationApplication numberUS 12/159,904Publication dateNov 12, 2009Filing dateDec 28, 2006Priority dateJan 5, 2006Also published asCA2635980A1, CA2635980C, CN101346101A, CN101346101B, CN102415888A, EP1961382A1, EP1961382A4, US7927290, US20110160614, WO2007077930A1Publication number12159904, 159904, US 2009/0281455 A1, US 2009/281455 A1, US 20090281455 A1, US 20090281455A1, US 2009281455 A1, US 2009281455A1, US-A1-20090281455, US-A1-2009281455, US2009/0281455A1, US2009/281455A1, US20090281455 A1, US20090281455A1, US2009281455 A1, US2009281455A1InventorsMasaki Fujiwara, Toshihiro Akiyama, Yoshinori AmanoOriginal AssigneeMatsushita Electric Industrial Co., Ltd.Export CitationBiBTeX, EndNote, RefManReferenced by (6), Classifications (14), Legal Events (5) External Links: USPTO, USPTO Assignment, EspacenetBlood test apparatusUS 20090281455 A1Abstract 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.
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 which is held by the plunger so as to allow the one end to be inserted and removed; 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 and removed and that allows the lancet to move inside; 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 inserted to and removed from the attaching part detachably; and the two or more connectors are arranged so as to contact with the connection electrodes of the blood sensor. 2. The blood test apparatus according to claim 1, wherein:
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; and 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. 3. 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.
4. 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.
5. The blood test apparatus according to claim 1, wherein the blood collection needle and the lancet of the blood sampling cartridge are integrated.
6. The blood test apparatus according to claim 1, wherein the blood sampling cartridge can be divided into the integrated blood collection needle and lancet, and the holder to which the blood sensor is attached.
7. The blood test apparatus according to claim 1, wherein the blood sensor comprises:
a base plate; a storing part 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 storing part, and, into which blood in the storing part flows by capillary action; a detecting section provided in the supply channel; and an air hole that communicates with the supply channel. 8. The blood test apparatus according to claim 7, wherein:
the storing part provided in the base plate comprises an opening part in a surface that abuts on the skin and a closing part in a reverse surface of the surface that abuts on the skin; and the closing part can be punctured with the blood collection needle. 9. The blood test apparatus according to claim 8, wherein an area of the air hole is smaller than an area punctured with the blood collection needle.
10. The blood test apparatus according to claim 8, wherein a diameter of the air hole is 10 to 80 percentages of a diameter of the blood collection needle.
11. The blood test apparatus according to claim 7, wherein the storing part provided in the base plate comprises:
an opening part in a surface that abuts on the skin; and an opening part through which the blood collection needle can pass, in an reverse surface of the surface that abuts on the skin. 12. The blood test apparatus according to claim 11, wherein an area of the air hole is smaller than an area of the opening part through which the blood collection needle can pass.
13. The blood test apparatus according to claim 11, wherein an area of the opening part through which the blood collection needle can pass is larger than an area of the air hole and smaller than an area of the opening part of the storing part in the surface that abuts on the skin.
14. The blood test apparatus according to claim 11, wherein the blood sampling cartridge comprises a cap that covers the blood collection needle of the lancet, and the cap passes through the storing part.
15. The blood test apparatus according to claim 7, wherein at least part of the base plate is formed with a transparent member, so that blood supplied to inside of the supply channel can be seen.
16. The blood test apparatus according to claim 7, 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 on the skin. 17. The blood test apparatus according to claim 7, wherein:
the detecting section comprises two or more detection electrodes for detecting components of the sampled blood and a reagent, which two or more detection electrodes are connected to the two or more connection electrodes, respectively; and one of the two or more connection electrodes compose a reference electrode for specifying arrangement of the two or more connection electrodes. 18. The blood test apparatus according to claim 17, wherein the reference electrode is electrically connected to one of the two or more connection electrodes via a conductor.
19. The blood test apparatus according to claim 17, wherein the reference electrode is electrically insulated from one of the two or more connection electrodes.
20. The blood test apparatus according to claim 17, wherein the reference electrode can be specified by measuring resistance values between the reference electrode and each of the two or more connection electrodes.
21. The blood test apparatus according to claim 7, wherein a negative pressure can be supplied to the storing part via the air hole.
22. The blood test apparatus according to claim 7, wherein a volume of the storing part is one to twenty times a volume of the supply channel.
23. The blood test apparatus according to claim 7, wherein a volume of the storing part is four to fifteen times a volume of the supply channel.
24. The blood test apparatus according to claim 7, wherein:
a substrate that forms part of the storing part;
a spacer that is provided on the substrate and that forms the supply channel and part of the storing part; and
a cover which is provided on an upper surface of the spacer and in which the air hole is formed; and
a thickness of the substrate is greater than a thickness of the spacer. 25. The blood test apparatus according to claim 7, wherein hydrophilicity treatment is applied to an inner surface of the supply channel, and water repellent treatment is applied to a back surface of the base plate, wherein the front surface of the base plate abuts on the skin.
26. The blood test apparatus according to claim 25, wherein an upper surface of the storing part is less hydrophilic than an inner surface of the supply channel.
27. The blood test apparatus according to claim 25, wherein an upper surface of the storing part is less water repellent than the back surface of the base plate, wherein the front surface abuts on the skin.
28. The blood test apparatus according to claim 7, wherein water repellent treatment is applied near the storing part in the front surface of the base plate, which front surface abuts on the skin.
29. The blood test apparatus according to claim 28, wherein water repellent treatment is applied to the whole front surface of the base plate, which front surface abuts on the skin.
30. The blood test apparatus according to claim 28, wherein water repellent treatment is applied to the back surface of the base plate, wherein the front surface abuts on the skin.
31. The blood test apparatus according to claim 7, wherein an upper surface of the storing part is less water repellent than part near the storing part in a front surface of the base plate, which front surface abuts on the skin.
32. The blood test apparatus according to claim 7, wherein a projecting bank is provided near an opening part of the storing part on a front surface of the base plate, which front surface abuts on the skin.
33. The blood test apparatus according to claim 32, wherein the bank is formed in an integrated manner with the base plate.
34. The blood test apparatus according to claim 32, wherein the bank is constructed with a different member from the base plate.
35. The blood test apparatus according to claim 32, wherein:
a cover which is provided on an upper surface of the spacer, and in which the air hole is formed; and
the base plate is manufactured with a method comprising the steps of:
preparing a substrate where a bank is formed near an opening part of the storing part;
stacking the spacer to a surface of the substrate where the bank is not formed; and
stacking the cover to the spacer.
36. The blood test apparatus according to claim 1, further comprising a means that applies a negative pressure near part of the skin punctured with the blood collection needle.
37. The blood test apparatus according to claim 1, further comprising a display section that displays a measurement result at the measuring circuit, or a transmitting section that transmits the measurement result.
38. A blood sampling cartridge that can be attached to and removed from the blood test apparatus according to claim 1.
39. A blood sampling cartridge that can be attached to and removed from the blood test apparatus according to claim 2. Description
Patent Document 1: Japanese Patent Application Publication No. 2003-524496 Patent Document 2: Japanese Patent Application Laid-Open No. 2000-000231 DISCLOSURE OF INVENTION Problems to be Solved by the Invention However, above-described blood test apparatus 1 needs to attach lancet 4 to which blood collection needle is attached, to plunger 3 as preparation before use and attach sensor 6 to one end 2 a of housing 2, and this work is troublesome.
FIG. 14 is a plan view that disassembles the blood sensor, part of the base plate being formed with transparent material;
BEST MODE FOR CARRYING OUT THE INVENTION An Overview of the Blood Test Apparatus The blood test apparatus according to the present invention has: (1) a housing; (2) a measuring circuit that is accommodated in the housing; (3) two or more connectors that are electrically connected to the measuring circuit; (4) an attaching part that is formed in one side of the housing; (5) a plunger that moves back and forth in the housing; (6) a lancet, one end of which is held by the plunger so as to allow the one end to be inserted and removed; (7) a blood collection needle that is attached to the other end of the lancet; (9) a holder that is inserted and fixed inside the attaching part, and inside which the lancet can move; and (10) a blood sensor that is attached to one end of the holder and that has two or more connection electrodes.
[The Blood Sampling Cartridge] FIG. 2 is a diagrammatic perspective view of assembly of an example of a blood sampling cartridge. Blood sampling cartridge 22-1 shown in FIG. 2A has holder 23, blood sensor 24, lancet 25 and blood collection needle 26. Lancet 25 and blood collection needle 26 are formed in an integrated manner so as not to disjoin easily. On the other hand, holder 23 and lancet 25 may be integrated after being manufactured separately, and may be separable from each other.
[The Blood Sensor] As described above, blood sampling cartridge 22 has blood sensor 24.
FIG. 10 is a plan view that disassembles blood sensor 24. Blood sensor 24 has cover 48 shown in FIG. 10A, spacer 47 shown in FIG. 10B and substrate 41 shown in FIG. 1C.
FIG. 10A is a plan view of cover 48. Cover 48 has an approximate cross shape, air hole 48 c is provided at cross-shape first convex part 48 d so as to correspond to the tip part of supply channel 47 d. Preferably, the diameter of air hole 48 c is approximately 50 μm. The material of cover 48 is plastic, and preferably polyethylene terephthalate. The thickness of cover 48 may fall in a range of 0.05 to 0.25 mm (preferably 0.075 mm).
[The Thickness of the Substrate, Spacer and Cover] The thickness of substrate 41, spacer 47 and cover 48 of blood sensor 24, and its ratio are important for sampling the blood. First, to cause the capillary action in supply channel 47 d, the thickness of the spacer preferably falls within the range from 0.05 to 0.15 mm (preferably 0.1 mm).
Further, with blood sensors 24-1 to 24-4 shown in FIG. 9A to FIG. 9D, to adjust the volume of storing part 49 and supply channel 47, it is necessary to adjust the thickness of spacer 47 and the thickness of substrate 41. The thickness of the substrate is preferably the same as the thickness of the spacer or greater, and preferably falls within the range where the thickness of substrate 41: the thickness of spacer 47=1:1 to 5:1 (preferably, 2.5:1). Further, the thickness of cover 48 is preferably made less than the thickness of substrate 41 so that the total thickness of blood sensor 24 is preferably made thin. Therefore, the thickness of substrate 41: the thickness of spacer 47: the thickness of cover 48 may be 2.5:1.3:1 as a reference.
[The Relationship Between the Volume of the Blood Storing Part and the Volume of the Blood Supply Channel] As described above, blood sensor 24 has blood storing part 49 and blood supply channel 47 d, and the volume of blood storing part 49 is one to twenty times the volume of blood supply channel 47 d, preferably four to fifteen times, and, more preferably, five to seven times. For example, the volume of blood storing part 49 of blood sensor 24-1 shown in FIG. 9A may be 0.904 μL, and the volume of blood supply channel 47 d may be 0.144 μL. Further, the volume of blood storing part 49 of blood sensor 24-2 shown in FIG. 9B may be 0.766 μL, and the volume of blood supply channel 47 d may be approximately 0.144 μL. In this way, by controlling the volume ratio between blood storing part 49 and blood supply channel 47 d adequately, the speed of the blood flowing in the supply channel can be controlled to be constant and the flow rate of the blood flowing in the supply channel can be controlled adequately, so that the blood does not wash out reagent 50 and reacts with reagent 50 sufficiently, which realizes a correct test.
[The Relationship Between the Area of the Air Hole and the Area of the Puncturing Hole] The diameter of air hole 48 c is preferably 50 to 500 μm (for example, 50 μm). If the diameter of air hole 48 c is made small, blood sampled excessively is less likely to flow out from air hole 48 c. Further, the area of air hole 48 c is preferably made smaller than the area of puncturing hole 48 e formed by blood collection needle 26. When the area of air hole 48 c is made larger than the area of puncturing hole 48 e, the resistance of puncturing hole 48 e against the flow of blood 23 becomes smaller than the resistance of air hole 48 c. Therefore, most of blood 13 sampled excessively flows out from puncturing hole 48 e, and the amount of blood 13 flowing out from air hole 48 c becomes extremely small. Accordingly, even if the blood is sampled excessively, reagent 50 is not washed out. That is, reagent 50 does not move from detecting section 40, and the components of blood 13 are examined correctly.
[The Relationship of Water-Repellency and Hydrophilicity in the Parts of the Blood Sensor] First, the reverse side of cover 48 (the surface pasted to the spacer) corresponding to �the inner surface of supply channel 47 d� is preferably subjected to hydrophilicity treatment to make the blood smoothly flow in supply channel 47 d by capillary action. Further, the reverse side of cover 48 corresponding to �the upper side of storing part 49� is preferably less hidrophilic than the reverse side of cover 48 corresponding to the inner surface of supply channel 47 d to make the blood more smoothly flow in supply channel 47 d. The surface of cover 48 (the reverse side of the surface pasted to the spacer) is preferably subjected to water-repellency treatment to prevent the blood in storing part 49 from flowing out more than necessary from air hole 48 c or a hole of cover 48 (for example, puncturing hole 48 e by blood collection needle 26). Further, the reverse side of cover 48 corresponding to �the upper side of storing part 49� is preferably less water-repellent than the surface of cover 48 to prevent more effectively the blood in storing part 49 from flowing out.
[The Arrangement of Electrodes in the Blood Sensor] FIG. 15 is a perspective plan view of blood sensor 24. Detection electrodes 42, 43, 44 and 45 are formed on substrate 41, and these detection electrodes 42 to 45 function as, for example, an active electrode, a sensing electrode, a counter electrode and an Hct electrode, in that order. The �active electrode� refers to an electrode for measuring blood components, the �sensing electrode� refers to an electrode for sensing whether or not the blood is supplied to the detecting section, the �counter electrode,� refers to a counterpart electrode of the active electrode, and the �Hct electrode� refers to an electrode for measuring the hematocrit level in the blood. Detection electrodes 42 to 45 are connected to relevant connection electrodes 42 a, 43 a, 44 a and 45 a, respectively, and connection electrodes 42 a, 43 a, 44 a and 45 a are arranged along the outer periphery of substrate 41.
[The Principle of Measuring the Blood Sugar Level] FIG. 18 shows the measurement principle of blood test apparatus 20 that measures the blood sugar level of blood. Glucose 101 in blood reacts with glucose dehydrogenase (GDH) 103 specifically to give product 102, and potassium ferricyanide 104 is reduced to generate potassium ferrocyanide 105.
[Test Process] FIG. 20 shows the relationship between blood collection needle 26 and blood sensor 24 upon blood sampling by the blood test apparatus. As shown in FIG. 20A, substrate 41 of blood sensor 24 abuts on the skin of the patient (such as the skin of a finger). When blood collection needle 26 is shot in the direction of the arrow, blood collection needle 26 projects from blood sensor 24, and breaks through cover 48 in case that there is no opening part in cover 48 forming the upper side of storing part 49, and further, punctures skin 7. Blood 13 flows out from punctured skin 7, and the outflow of blood 13 is led to storing part 49. Blood 13 led to storing part 49 flows into supply channel 47 d, and, further, led to detecting section 40 by capillary action.
[A Block Diagram of the Blood Test Apparatus] FIG. 23 is a block diagram of blood test apparatus 20. The same components will be assigned the same reference numerals for ease of explanation. Blood test apparatus 20 in FIG. 23 has blood sensor 24 a shown in FIG. 16. Connection electrodes 42 a to 45 a of blood sensor 24 a are connected to terminals 33 a to 33 e. Terminals 33 a to 33 e are connected to switch circuit 71, and the output of switch circuit 71 is connected to the input of current/voltage converter 72. The output of current/voltage converter 72 is connected to the input of calculating section 74 via analogue/digital converter (hereinafter A/D converter) 73. The output of calculating section 74 is connected to display section 75 (for example, a liquid crystal display device) and also connected to the input of transmitting section 77.
[The Negative Pressure Means] The blood test apparatus of the present invention may have a negative pressure means. By the negative pressure means, a negative pressure is preferably applied near the part of the skin punctured with blood collection needle 26. Therefore, blood test apparatus 20 with the negative pressure means preferably has a member for surrounding the neighborhood of the punctured part of the skin, and may apply a negative pressure to the space surrounded by the member.
Referenced byCiting PatentFiling datePublication dateApplicantTitleUS8221335 *Jun 29, 2011Jul 17, 2012Panasonic CorporationBlood test apparatus and blood test methodUS8395363Oct 14, 2008Mar 12, 2013Panasonic CorporationHigh voltage generation circuit, puncture device, and blood test deviceUS8439848Sep 4, 2008May 14, 2013Panasonic CorporationBlood testing deviceUS8529472Sep 4, 2008Sep 10, 2013Panasonic CorporationBlood analysis device and blood analysis system using the sameUS8657762Jul 18, 2008Feb 25, 2014Panasonic CorporationBlood test deviceUS20110257498 *Jun 29, 2011Oct 20, 2011Panasonic CorporationBlood test apparatus and blood test method* Cited by examinerClassifications U.S. Classification600/576, 600/583International ClassificationA61B5/151Cooperative ClassificationA61B5/1411, A61B5/1486, A61B5/15186, A61B5/14535, A61B5/14532, A61B2562/0295European ClassificationA61B5/1486, A61B5/145G, A61B5/145H, A61B5/14B2, A61B5/151SLegal EventsDateCodeEventDescriptionApr 29, 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