CN101132733A

CN101132733A - Biosensor coupled with needle

Info

Publication number: CN101132733A
Application number: CNA2006800067448A
Authority: CN
Inventors: 中村秀明; 后藤正男; 轻部征夫
Original assignee: National Institute of Advanced Industrial Science and Technology AIST
Current assignee: National Institute of Advanced Industrial Science and Technology AIST
Priority date: 2005-03-02
Filing date: 2006-03-01
Publication date: 2008-02-27
Also published as: JP2006239062A; JP4576624B2

Abstract

It is intended to provide a biosensor coupled with a needle which can be easily assembled owing to its simple constitution while maintaining a high strength, by which a sample body fluid can be surely collected without waste, in which a puncture needle is not contaminated with a reagent layer, and which can be conveniently packaged and easily carried and remains sanitary even after using. It is also intended to provide a biosensor coupled with a needle which can be easily assembled without lowering its strength and by which a sample body fluid can be surely collected without waste while preventing a puncture needle from contamination with a reagent layer. A biosensor coupled with a needle comprising a puncture needle penetrating into the skin of a subject for collecting a body fluid and the body of the biosensor for analyzing the body fluid which have been integrated together, wherein the puncture needle perpendicularly moves and passes throughout the biosensor body due to a driving means outside to thereby penetrate the skin. A biosensor coupled with a needle which is composed of a biosensor comprising an electrically insulating baseboard, a cover, a spacer located in a space between them, electrodes and a reagent layer and a puncture needle penetrating into the skin of a subject for collecting a body fluid integrated together, wherein a thorough-hole of the puncture needle is provided in the cover member forming a blood collection port which is located at the edge in the longitudinal direction of the biosensor.

Description

Biosensor coupled with needle

Technical field

The present invention relates to biosensor coupled with needle.More detailed saying so relates to the biosensor coupled with needle with following structure, will be used to thrust skin and obtain the puncture needle of body fluid (blood) and take the body fluid that takes out from skin surface and the biosensor that is used to analyze integrated.

Background technology

In the past, sometimes diabetics to want the own dextrose equivalent of measuring in the blood of taking a blood sample be blood glucose value.In this case, the patient uses the hemostix that is called as lancet of loading and unloading blood taking needle, and the finger tip or the arm etc. that blood taking needle are thrust self are taken a blood sample, and the blood of adopting is delivered in the blood glucose value analyser measured blood glucose value.This mensuration mode, the patient must carry and comprise that blood glucose value analyzer, lancet, blood taking needle and analysis element are like this by several cover mensuration utensils that constitutes, when needed they are made up and measure, operational approach also needs long-time training, and can carry out reliable determination to patient self then needs considerable time.But in fact for the mensuration at the position (stomach wall, ear lip etc.) beyond finger tip or the arm, even the practician also is difficult.The demand of supplying with according to the little low infringement corpse or other object for laboratory examination and chemical testing of misery has been developed the biosensor that corpse or other object for laboratory examination and chemical testing amount just can be measured below 1 μ l in recent years, and under the situation of this denier, operation from a corpse or other object for laboratory examination and chemical testing to biosensor that accurately supply with is very difficult.Its result causes measuring failure, must puncture once more as the patient of person to be measured, and biosensor also will be changed, and redeterminates.

Patent documentation 1: day disclosure special permission 09-266898 communique

Patent documentation 2: Japan bulletin special permission 08-20412 communique

So, considered several biosensor coupled with needle.At first, patent documentation 3 discloses a kind of biosensor coupled with needle, in the pen type that possesses the puncture needle drive division (double-colored ball pen shape) determinator inside puncture needle is installed in different positions respectively with biosensor, the determinator leading section of pen shape is touched the skin of subject, after puncture, biosensor is exposed at leading section, carry out the mensuration of blood glucose by blood sampling.But this method need be installed in pin and biosensor respectively in the determinator, and therefore trouble is not eliminated.

Patent documentation 3: day disclosure special permission 2000-217804 communique

In addition, disclosing a kind of biosensor coupled with needle at patent documentation 4, puncture needle is used external drive, is that puncture needle is along the parallel mobile integrative-structure of elongated scutellate biosensor length direction.But the puncture needle of the type exposes from biosensor; so need the lid of protection puncture needle front end; and; because puncture needle moves at the blood sampling carrying path and the reagent layer of biosensor; so puncture needle is before thrusting the skin of subject, there is the danger of being polluted by reagent on the surface of puncture needle.

Patent documentation 4: Japan public again table special permission 2002-056769 communique

And, existing biosensor coupled with needle complex structure, many as the needed blood sampling volume of sample liquid, and the influence of wasted space of entering etc. is arranged.Thereby the problem that also has the connecting airtight property of skin etc. of puncture blood collecting mouth and subject.Be used to protect from infection and cost that the packing of reagent deterioration etc. is shared many, use the back discarded insufficient for the consideration of infecting disease etc., the driving of puncture usefulness is arranged on the determinator side, is that the biosensor coupled with needle unit can't bear the ballistic structure that when puncture drive etc., has a lot of problems.

Summary of the invention

The object of the present invention is to provide a kind of biosensor coupled with needle, it is simple in structure and can not damage intensity, and assembling easily, can not waste and carry out taking of sample body fluid reliably, puncture needle can not polluted by reagent layer, and by shrink-wrap make carry also easy, also health after the use.

In order to reach purpose of the present invention, the invention provides a kind of biosensor coupled with needle, wherein, be used to puncture needle that thrusts subject skin and take body fluid and the biosensor body formation one that is used to carry out body fluid analysis, the driving mechanism of this puncture needle by the outside drives and connects the biosensor body in vertical direction, and thrusts skin.

In addition, the invention provides a kind of biosensor coupled with needle, its biosensor body possesses: electrical insulating property substrate and lid, be arranged on by described electrical insulating property substrate and cover folded spatial dottle pin, electrode and reagent layer, by making it and be used to thrust subject skin and take the puncture needle of body fluid integrated, has a through hole of puncture needle at the cover that is formed with blood sampling mouthful of the long axis direction front end setting of biosensor body.

Biosensor coupled with needle of the present invention can not damage intensity and assembling is easy, can mass production.In addition, have following good effect, that is, can not waste and carry out taking of sample body fluid reliably, because puncture needle connects the position different with reagent layer, so can not polluted by reagent layer.And then, have to make and carry easily by shrink-wrap, the also characteristics of health after the use, it can use as tube.In addition, the invention provides a kind of biosensor coupled with needle determinator, it carries easily and can widespread usage, it has: the data such as hematocrite value of the temperature of measuring environment and blood are reflected to function (temperature correction and hematocrite value are proofreaied and correct) during blood glucose value calculates accurately, the calibration function of compensation batch difference, automatic illumination functions in dark place display part and puncture portion, but also have: the vocal guidance functional harmony sound recognition function corresponding with the visual disorder that causes owing to diabetes, utilize the determination data managerial function of built in radio clock, the function that determination data etc. is communicated to medical institutions etc., and charge function etc.

Description of drawings

Fig. 1 is the figure of a kind of embodiment of expression biosensor of the present invention;

Fig. 2 is the figure of the another kind of embodiment of expression biosensor of the present invention;

Fig. 3 is the figure of the another kind of embodiment of expression biosensor of the present invention;

Fig. 4 is the figure of a kind of embodiment of expression attraction type biosensor of the present invention;

Fig. 5 is a kind of figure of embodiment that expression has the attraction type biosensor of manner of packing of the present invention;

Fig. 6 is the figure of the another kind of embodiment of expression attraction type biosensor of the present invention;

Fig. 7 is the figure of the another kind of embodiment of expression biosensor of the present invention;

Fig. 8 is the figure of another kind of embodiment that expression has the biosensor of manner of packing of the present invention;

Fig. 9 is the figure of a structure example of expression biosensor coupled with needle of the present invention;

Figure 10 is that expression embeds the holder be positioned at puncture needle housing bottom of the present invention to biosensor and the figure of the structure example of the biosensor coupled with needle that forms;

Figure 11 is a structure example of pick off holder of the biosensor coupled with needle of expression with manner of packing of the present invention and a figure who makes use-case of this pick off;

Figure 12 is the figure of an action example of expression biosensor coupled with needle of the present invention;

Figure 13 is the figure of expression biosensor coupled with needle of the present invention side and section one example thereof;

Figure 14 is the figure that represents another action example of biosensor coupled with needle of the present invention with side and section thereof;

Figure 15 is the figure of a structure example that expression has the attraction type pin one biosensor of manner of packing of the present invention;

Figure 16 is the figure of an action example that represents to have the attraction type pin one biosensor of manner of packing of the present invention with lateral section;

Figure 17 is the figure of another structure example that expression has the attraction type pin one biosensor of manner of packing of the present invention;

Figure 18 is the figure of another action example that represents to have the attraction type pin one biosensor of manner of packing of the present invention with lateral section;

Figure 19 is the figure of another action example that represents to have the attraction type pin one biosensor of manner of packing of the present invention with lateral section;

Figure 20 is the figure of expression packaging determinator one example of lancet of installing on the biosensor coupled with needle of the present invention;

Figure 21 is the figure that expression is installed to the biosensor coupled with needle with manner of packing of the present invention one example of the packaging determinator use of lancet;

Figure 22 is the figure that expression is installed to the biosensor coupled with needle with manner of packing of the present invention another example of the packaging determinator use of lancet;

Figure 23 is the figure that expression is installed to the biosensor coupled with needle with manner of packing of the present invention another example of the packaging determinator use of lancet;

Figure 24 is the figure that expression is installed to the biosensor coupled with needle with manner of packing of the present invention another example of the packaging determinator use of lancet;

Figure 25 is the figure that expression is installed to the attraction type pin one biosensor with manner of packing of the present invention another example of the packaging determinator use of lancet;

Figure 26 is the figure that expression is installed to biosensor coupled with needle of the present invention one example of packaging determinator of lancet and enforcement mensuration;

Figure 27 is the figure of one example of action when representing that the section of side is from the side seen coupled with needle pick off blood sampling of the present invention;

Figure 28 is the figure of one example of action when representing that the section of side is from the side seen the attraction type pin one biosensor blood sampling with manner of packing of the present invention;

Figure 29 is the figure of another example of action when representing that the section of side is from the side seen the attraction type pin one biosensor blood sampling with manner of packing of the present invention;

Figure 30 is the figure that expression in the dark is installed to biosensor coupled with needle of the present invention one example of packaging determinator of lancet and enforcement mensuration;

Figure 31 is the figure of an example that the container of the biosensor coupled with needle with manner of packing of the present invention is accommodated in expression;

Figure 32 is the figure that container one example of the attraction type pin one biosensor with manner of packing of the present invention is accommodated in expression;

Figure 33 is the figure of a structure example of expression biosensor of the present invention;

Figure 34 is that expression possesses the puncture figure of a structure example of biosensor of film of the present invention;

Figure 35 is the figure of a structure example that expression possesses the biosensor of the anti-skidding portion of the present invention;

Figure 36 is the figure of a structure example of expression puncture portion;

Figure 37 is the figure of a kind of embodiment of expression puncture portion;

Figure 38 is a structure example of expression biosensor coupled with needle of the present invention and the figure that makes use-case thereof;

Figure 39 is a front elevation that makes use-case of expression biosensor coupled with needle of the present invention;

Figure 40 is a side view that makes use-case of expression biosensor coupled with needle of the present invention;

Figure 41 is that expression is accommodated the figure of the intravital structure example of shell to biosensor coupled with needle of the present invention;

Figure 42 is that expression is the figure that is housed in the structure example that the intravital biosensor coupled with needle of shell is connected with determinator;

Figure 43 is the figure of shrink-wrap one example of expression biosensor coupled with needle housing.

Description of symbols

1 substrate

2 lids

3 electric conductors

4 through holes

5 puncture films

6 non-dottle pin parts

7 blood sampling carrying paths

8 bond layers (dottle pin)

9 terminals

10 puncture blood collecting mouths

11 air outlets

12 puncture needles connect the road

13 electrode reaction portions (reagent layer)

14 blood samplings import guide

15 grooves

16 airtight medicated cap portions

17 protecting film

18 powerful adhesive portion

19 can paste stripping portion

20 non-bonded parts

21 biosensor coupled with needle (pick off tube)

22 puncture needle holders

23 external drive introduction parts

24 puncture needle fixing bases

25 helical spring guides

26 puncture needles

27 helical springs

28 puncture needle guides

29 puncture needle moving parts

30 puncture needle holder substrates

31 sensor base plate holders

32 sensor base plates

33 sender unit cap holders

34 sender unit caps

35 sensor base plate fixtures

36 sensor base plate exterior sides

37 sensor base plate inner face side

38 sender unit cap inner face side

39 sender unit cap exterior sides

40 dotted lines that are used to have an X-rayed

41 external drives

42 biosensor bodies

43 puncture needle drivers

44 biosensor coupled with needle tube introduction parts (biosensor coupled with needle collet chuck seat)

45 shank parts

46 guidance panels

47 display parts

48 action buttons

49 adapter portions

50 puncture start buttons

51 Non-slip materials

52 medicated caps

53 bands are taken off the medicated cap of curium

54 fingers

55 blood samplings

56 coupled with needle pick off accepting boxs

57 pick off separating parts (airtight medicated cap and protecting film)

58 retractility films

59 check-valves

60 aeration films

61 puncture needle housings

62 awls

63 hooks

64 folding lines

100 lids

102 dottle pins

103 substrates

104 through holes

105 bond layers

106 resist layers

107 electric conductors

108 puncture needles connect the road

109 blocks

110 electrodes

111 terminals

112 blood sampling mouths

113 electrode reaction portions (reagent layer)

114 puncture needle portions

115 helical springs

116 puncture needle holders

117 external drive introduction parts

118 helical spring fixed parts

119 puncture needle supporting masses

120 puncture needles

121 puncture needle holder introduction parts

122 puncture needle holder blocks

123 puncture portions

124 external drives

125 biosensor bodies

126 puncture needles portion-biosensor holder

127 subjects

128 biosensor coupled with needle

129 blood samplings

130 biosensor coupled with needle housings

131 determinators import uses guide

132 determinators

133 packaging medicated caps

134 puncture films

135 puncture needle guides

136 biosensor housing protuberances

137 anti-skidding portions

138 upper shed portions

139 under shed portions

140 housing introduction parts

141 adapters

142 wirings

The specific embodiment

Biosensor coupled with needle of the present invention possesses biosensor, and this biosensor can be by utilizing silk screen printing to be printed on the insulated substrate such as plastics and make easily electrode pattern with as the bond layer of dottle pin etc.Be described in further detail for this biosensor.

(biosensor)

This biosensor comprises the substrate of insulating properties, cover with the bonded insulating properties of substrate by the bond layer of double as dottle pin layer, and the electrode on the substrate that is formed by the folded space of substrate and lid, be provided with the blood sampling carrying path that extends to air outlet from the puncture blood collecting mouth by electrode by substrate and the folded space of lid, connect film (being called the puncture film later on) from last beginning with puncture needle, substrate, dottle pin, the order of lid is overlapping, cover be provided with as the puncture blood collecting mouth be used for from below the through hole of blood sampling body fluid, also be provided with the through hole of substrate with the through hole position overlapped, the puncture film is set thereon, is provided with puncture needle perforation road from covering film.Lid be an end of its long axis direction and substrate do not overlap ground bonding, and be formed with the blood sampling mouthful.On the part of the lid that forms the blood sampling mouth, be provided for connecting the hole of puncture needle.By through hole being arranged on this position puncture needle is not contacted with the reagent layer that forms on the electrode, have the effect that pin can not polluted by reagent.On substrate, forming as the anti-skidding portion that rubber system also can be set below the end of the puncture blood collecting mouth of subject contact portion.Like this in when puncture, just be difficult between the skin of biosensor coupled with needle and subject produce and misplace, can carry out safety and puncture reliably and take a blood sample.On substrate, forming as the anti-skidding portion that rubber system also can be set below the end of the puncture blood collecting mouth of subject contact portion.Like this in when puncture, just be difficult between the skin of biosensor coupled with needle and subject produce and misplace, can carry out safety and puncture reliably and take a blood sample.

The biosensor that the electrode that the sample carrying path is passed through is provided with reagent layer contacts with reagent layer on the electrode by making the sample sent into from the sample carrying path, and sample and reagent are reacted.This reaction is monitored as the electric variation of electrode.

In said structure, puncture blood collecting mouth periphery and blood sampling carrying path surface coated interfacial agent and oils and fats that also can be on cover.By coating interfacial agent and oils and fats, can make the mobile smooth and easy of sample.The electrode that is full of above blood sampling is provided with the biosensor of reagent layer, contact with reagent layer on the electrode by making the blood sampling sent into from blood sampling mouth, takes a blood sample and reagent reacts and make.This reaction is as the electric variation of electrode and monitored.

In addition, near the blood sampling carrying path the puncture blood collecting mouth, smooth and easy for the importing that makes blood sampling, also can adopt pyramidal structure to the bond layer figure.Equally, in order to suppress to import the above blood sampling of needs, also can narrow down air outlet or the aeration film partly is set at air outlet.

And then, in order in biosensor, to import blood sampling effectively, can be purpose also with the connecting airtight property that improves puncture blood collecting mouth and subject skin, the material of puncture blood collecting mouth is changed into soft material.Can use gel, elastomeric material, foaminess material etc. as soft material.As other methods that in biosensor, imports blood sampling effectively, can make around the puncture blood collecting mouth or outline has the convex structure.At this moment, the material as the convex structure can use gel, elastomeric material, foaminess material etc.For example, when the outline that makes the puncture blood collecting mouth has the convex structure,, just can make the cutaneous protuberance of subject, can puncture its summit by before puncture, the puncture part being pressed into biosensor coupled with needle.More than shown in the modification to the puncture blood collecting mouth, can also allow user grasp puncture position as puncture blood collecting mouth guide and work, can also have the effect of anti-skidding portion sensuously.

And then, in order visually to grasp puncture position, can also enumerate lighting mechanism from the sample introducing port.Illumination is the light of irradiation visible region, preferably the luminous body of the laser beam of light emitting diode etc. or organic EL etc.At luminous body is under the situation of light emitting diode, then the plate member of puncture needle housing, biosensor and puncture film etc. is formed with transparent material, and by light emitting diode being assembled in its inside, the site of puncture can throw light on.In puncture needle housing that forms by transparent material as previously mentioned and biosensor, as long as only the lid of the plate of puncture needle housing bottom and biosensor is set for the parts that absorb color, then only there is light to shine, so can obtain the spotlight of site of puncture from the sample introducing port.In addition, under the situation of using organic EL, then need only at least a portion of the lid of the plate of puncture needle housing bottom and biosensor or all carry out Surface Machining and just can with organic EL.As adopt above shown in electric power supply source during irradiation means, can enumerate the battery of determinator.At this moment, preferably the terminal by biosensor comes supply capability.

As the plate member of biosensor substrate and lid etc., so long as electrical insulating property, then can select plastics, degradable materials, paper etc.Suitable example as plastics can be enumerated polyethylene terephthalate.

Electrode can be made of carbon, silver, silver/silver chloride, platinum, gold, nickel, copper, palladium, titanium, iridium, lead, stannum oxide, platinum black etc.Can use carbon fibre tube, coiled carbon fibers, carbon atom nanometer pyramidal structure, fullerene, dendritic or their derivant as carbon.Such electrode can be formed on the plate member by silk screen print method, vapour deposition method, splash method, foliation method, coating process etc.

Electrode also can adopt by the bipolar fashion that acts on the utmost point and the utmost point is formed; By the effect utmost point, three utmost point modes that form to the utmost point with reference to the utmost point or more than this electrode mode of number of poles.At this, when three utmost point modes of employing, can also measure the translational speed of the blood sampling that in carrying path, imports the electrochemical gaging except carrying out for the determination object material, can measure hematocrite value like this.In addition, also can constitute by electrode system more than two groups.

Bond layer also can form by silk screen print method.For example can use acrylic resin bonding agent etc. as bonding agent, the bond layer that forms with the preferably about 10～100mm thickness of about 5～500mm works as dottle pin.In addition, in bond layer, also can contain reagent.

And then the electrode of biosensor can be stipulated that also resist layer can be by formation easily such as silk screen printings by resist layer.

Reagent layer forms by silk screen print method or allotter method, and this reagent layer can be undertaken by following exsiccant absorption method or common combined techniques to the curing on electrode surface or plate member surface.

When biosensor coupled with needle of the present invention is used for blood-sugar level measuring,, for example can adopts and contain as oxidasic glucoseoxidase with as the reagent of the potassium ferricyanide of amboceptor as the reaction reagent that is configured in the biosensor reacting part.

When above-mentioned reacting part during by blood dissolves, begin to carry out enzyme reaction, then the result is that the potassium ferricyanide with the conversion zone coexistence is reduced, the electron transit mediator of reduced form is that potassium ferrocyanide is put aside.Its amount is that concentration of glucose in the blood is directly proportional with substrate concentration.The reduced form electron transit mediator of having been put aside certain hour is oxidized by electrochemical reaction.The intrinsic electronic circuit of determinator comes computing, decision concentration of glucose (blood glucose value) according to the anode current of at this moment measuring, as the above-mentioned display part that is disposed at body surface that is displayed on.

Biosensor coupled with needle device of the present invention possesses: the measurement section of the electrical value of above-mentioned any biosensor, measurement biological sensor electrode and the display part that shows the measured value of measurement section.Can use current potential stepping chronoamperometry, coulometry, cyclic voltammetry etc. as the measuring method of this measurement section.And then this device can also load for example bluetooth (login trade mark) of radio as wireless means.

(biosensor coupled with needle)

Biosensor coupled with needle connects described biosensor at the position different with reagent layer, the puncture needle that is used for taking body fluid from the skin of subject is with in biosensor is accommodated in identical container together, and is that the boundary is divided into being received up and down and forms one with the substrate.

In the puncture needle housing of biosensor coupled with needle, be provided with guide, this guide puncture needle by external drive after the outside is outstanding, drive in accordance with regulations and be used to make its elastomer that turns back to the origin-location immediately and puncture needle.Because biosensor coupled with needle can carry out shrink-wrap, so remain health before use, and owing to be cartridge type, so can be housed in the special container of carrying convenience, and anyone can easyly attach it on the determinator reliably.By adopting the mode of this cartridge type, can make the convenience of biosensor coupled with needle that the raising of leap is arranged than existing method.Narrate the intravital structure of puncture needle shell in more detail below.

Puncture needle is housed in and is used in the housing that vertical direction drives, and the puncture needle that is driven by external drive mechanism in the puncture needle housing connects biosensor, and need possess the mechanism that turns back to the origin-location behind the skin of the subject that is used to puncture.As an example that satisfies this condition method, the guide that also can be provided for beyond the puncture needle housing, inside all becomes the track dislocation minimum degree.For example protecting with guide cylindraceous around the puncture needle that is arranged on puncture needle fixing base downside that is subjected to external drive; similarly; the little cylindric guide of radius ratio guide also is set on the puncture needle holder substrate of puncture needle housing; like this when puncture; guide on the puncture needle holder substrate has minim gap and enters into the guide inboard of puncture needle fixing base, thereby can guarantee the track of puncture needle according to the rules.Be used for taking the puncture needle of body fluid from the skin of subject, owing to according to circumstances need to connect puncture film described later, and then the puncture subject, so preferably have the intensity that to bear these and sharp, in addition, the pain in order to suppress to puncture, preferably thin puncture needle.Can use the puncture needle of for example Japanese Terumo Corp (テ Le モ society) system 21～33 specifications of market sale specifically.As long as can puncture the skin of subject, puncture needle can be a hollow needle, also can be non-hollow needle.

In addition, need and be used to make the puncture needle that is projected into the biosensor outside by external drive to turn back to the elastomer of origin-location.For example can consider helical spring as this elastomer.Helical spring can be arranged on the outside of the cylindric guide of being located at the intravital puncture needle fixing base of puncture needle shell downside.At this moment, owing to there is the guide that limits the puncture needle track, therefore helical spring moving only is limited on the above-below direction.In addition, except helical spring, it is also conceivable that and use the retractility film.At this moment, by the retractility film being fixed on puncture needle fixing base and this two place, puncture needle housing top, can access the effect same with helical spring.That is, when the puncture needle fixing base is from the top when mobile downwards by external drive, the bipartite distance of puncture needle fixing base and puncture needle housing top is drawn back, and the retractility film is stretched.So its opposite action is exactly along with the backing out of external drive, and can make puncture needle turn back to the origin-location.

The puncture needle holder that is used to make puncture needle to turn back to the elastomer of origin-location by external drive immediately after the outside is outstanding and drives puncture needle in accordance with regulations forms puncture portion together, puncture portion according to respect to skin to the mode of vertical direction driving in biosensor is housed in housing.In housing, need to possess the puncture needle that is used to driven-mechanism is driven and connect the lid that becomes biosensor blood sampling mouth, and behind the skin of puncture subject, turn back to the mechanism of origin-location.As an example that satisfies this condition method, the puncture needle portion-biosensor holder that limits puncture needle and biosensor stereoscopic configurations can be set also.Puncture needle portion-biosensor holder for example by supporting with cylindric guide (puncture needle guide) near the retroaction portion center of the puncture portion that is subjected to external drive, can make puncture needle in the puncture needle guide medial movement that limits by track when puncture.In addition,, preferably adopt by making the front end that forms biosensor blood sampling mouthful outstanding a little, and make user sensuously grasp the structure of site of puncture easily from housing in order to carry out puncture reliably to subject skin.

Puncture needle connects and is arranged on the through hole that biosensor covers, but from preventing blood, under being 20 °～90 ° preferably 30 °～60 ° state, the angle of puncture needle and biosensor body fixes during perforation by puncture needle portion-biosensor holder from the effusive viewpoint of through hole.

For example can enumerate helical spring as being used to make the elastomer that is arranged on puncture portion that turns back to the origin-location to the outside outstanding puncture needle of biosensor by external drive.Helical spring surrounds the periphery of puncture needle supporting mass, for example is fixed on the outside puncture that is arranged at puncture needle supporting mass top and drives introduction part and be used to limit between the puncture needle holder of puncture needle track.In addition, by the puncture needle holder being housed in puncture needle portion-biosensor holder, then can be comprising that helical spring puncture needle portion integral body is inserted in puncture needle portion-biosensor holder, can assemble simply.

Preferably be provided with and puncture at the through hole place that is arranged at lid film or puncture needle mobile interlock and open the gate of closing, and then the puncture film is set preferably.The film that punctures is arranged on the outside or the inboard of lid for the through hole that stops up biosensor, and from suppressing blood sampling volume lowly and after puncture, can not hindering the viewpoint that blood sampling is imported to sensor internal by capillarity, preferably be arranged on the inboard, its thickness is below 100 μ m, be preferably 10～50 μ m, use such puncture film from the good viewpoint of passing through that makes puncture needle.

When using the retractility film, can guarantee the air-tightness of puncture needle enclosure interior easily with described purpose.Therefore, by the mechanism that adjusts air pressure inside is set at the puncture needle housing, can also utilize the body fluid after the puncture captivation to be taken into biosensor inside.Can enumerate check-valves as the instrument of realizing this mechanism.That is, the effect by external drive makes and temporarily becomes high pressure in the puncture needle housing.After this pressure was descended, effect made it turn back to the power of original state on the retractility film.Its result, the air pressure of enclosure interior becomes lower than external pressure, obtains being used to take the captivation of body fluid like this.And then, by changing the retractility of this retractility film, can change the captivation of blood sampling, therefore can also reflect the difference of user body constitution (viscosity of blood).

Below, the puncture film is described.The puncture film that is positioned at biosensor substrate portion need not hinder after puncture by capillarity blood sampling is imported to sensor internal.Puncture film if do not make the material of carrying path internal volume variation along with the importing of blood sampling, the plate member that then can also save substrate, and make the puncture film have the effect of substrate.At this moment, because the film that punctures not is hard as long as connect airtight with puncture needle holder substrate with regard to the film that do not need to puncture, therefore, puncture needle can be selected the softish material of perforation easily.As the puncture film that satisfies this condition preferably by natural material, plastics, degradable materials, formation such as shape-memory material, and then preferably natural material can be enumerated: paper, collagen, cellulose, Cotton Gossypii etc., plastics can be enumerated: the foaminess material, artificial skin particularly, elastomeric material, film formation material etc., film formation material can be enumerated: cellophane, Vingon, polrvinyl chloride, polyvinyl acetate, polyimides, polyethylene, polyethylene terephthalate, polyvinyl alcohol, polylactic acid, polyester, polyamide, ethylene-vinyl alcohol copolymer, fluororesin etc.

And then the structure of puncture film also can be the multiple structure with two-layer above unlike material.For example under the situation of two membranes, the film of downside can be a thin film and do not have foraminous membranaceously fully, and upside can be the film etc. with volume that the hole of being opened by puncture is buried.The puncture film is the thin film of thickness below 100 μ m, the thickness that puncture needle is passed through easily.In addition, also can replace puncturing film and at the mobile interlock of the cap setting of biosensor and puncture needle and open the gate of closing.

By puncture film and reagent layer separate configurations, can prevent owing to puncture makes reagent attached on the syringe needle, therefore, safety and health.

Because the employed puncture needle of biosensor coupled with needle need connect puncture film and the subject that punctures, so preferably have to a certain degree intensity and sharp.In addition, the pain in order to suppress to puncture, preferably thin puncture needle.And then, owing to before using puncture needle, need it wholesomely is housed in the housing, therefore, also can make the surface of pin have photocatalyst function antibiotic, antiviral effect.At this moment, the film of titanium oxide or titanium dioxide preferably.

As the method that health when using is preserved biosensor coupled with needle of the present invention, the shrink-wrap method of using cementability protecting film (being called protecting film later on) etc. is arranged.Biosensor coupled with needle need be packed the puncture blood collecting mouth and/or the air outlet of the biosensor that contacts with extraneous gas, and the top of puncture needle housing is packed.Because above package means can also prevent that puncture needle from exposing, so not only aspect health, and also be important at secure context.

Under the situation of packing biosensor of the present invention, packing is effective with the puncture blood collecting mouth that extraneous gas directly contacts.As employed shrink-wrap body in this case, only is can be bonding and the protecting film peeled off.And then, protecting film except can carry out bonding at least and the bond layer peeled off, by non-bonded part is set, be used to carry out that protecting film is bonding and peel off handles knob and can set this part for.And then, by at least a portion of protecting film is fixed on the biosensor substrate with powerful adhesive linkage, can utilize the protecting film after peeling off to pack again.

In addition, in described biosensor, the boundary that comprises the electrode part at the part that does not comprise electrode of insulating properties substrate and insulating properties substrate has the cut-out line, this cut-out line is provided on the cover also consistent with the cut-out line on the substrate, by the part that does not comprise electrode of insulating properties substrate is separated along cutting off line, then can use the biosensor that air outlet is opened.At this moment; opening has the part powerful bonding with protecting film with at least a portion of medicated cap portion; and then; the adhesive portion that can carry out bonding disengagement with the bonding portion of biosensor body is set on protecting film; when using biosensor; by medicated cap is separated from the biosensor body, and can protecting film also be peeled off simultaneously, can take such structure.If adopt this structure, then can after using, biosensor paste into original state again to the package body that constitutes by medicated cap and protecting film.

Equally, consider the manner of packing of biosensor coupled with needle, then also need protect for the terminal of biosensor.At this moment, can cover the terminal on the insulating properties substrate with lid.Can bond layer be set yet, but the fold line that can fold is set, outside terminal is exposed along this fold line covering of terminal of covering.Fold line as this situation can be enumerated perforated lines and line of cut etc.

Carry out the method for shrink-wrap for the housing upper and lower when using in biosensor is housed in housing, first can use medicated cap.By only cap on housing top etc., just can pack the most simply, in addition, by the take off curium of binding on medicated cap with housing, in using, biosensor coupled with needle can keep medicated cap to open, after use, cover medicated cap once more, then can the biosensor coupled with needle after using not discarded to influence such as infected disease.Like this, under the situation of using medicated cap, has the advantage that the outside of housing puncture driving introduction part and the blood sampling mouth that is positioned at downside are packed respectively on every side.

Can enumerate the example that uses protecting film as second method.Protecting film is employed identical with biosensor, can carry out bondingly and peel off, and also can be used as knob portion non-bonded part is set, and at least a portion of protecting film is fixed on the puncture needle housing by powerful adhesive linkage.By powerful adhesive linkage is set, in biosensor coupled with needle uses, can keep protecting film and be stripped from state, by the packing again after using, then can the biosensor coupled with needle after using not discarded to influence such as infected disease.

And then, can directly adopt the top situation that the retractility film is arranged on puncture needle housing top that illustrated as third party's method.That is, the situation of this mode, because the puncture needle enclosure interior keeps air-tightness, so this is the mode that does not need to pack the biosensor coupled with needle tube that comprises the puncture needle housing.If adopt this mode, owing to do not need the shrink-wrap of puncture needle housing section, therefore, can save operation (trouble) and the operation of packing again of using the front opening packing simultaneously, this is a good packing method of using most convenient in the example of being enumerated so far.

As the method for the Portability that improves determinator and biosensor coupled with needle tube, also can use and to concentrate the box of accommodating to a plurality of tubes.Accepting box for example is the type that can accommodate 10 tubes, can make the size of ball pen degree.Why tube of the present invention carries by this way, and this is to be difficult to the element of packing usually owing to comprised the terminal etc. of biosensor, therefore can guarantee the not vulnerable safe shape of user.

(biosensor coupled with needle determinator)

Biosensor coupled with needle of the present invention one example of determinator, it is characterized in that, operability and the durability that can guarantee to use the mensuration of the biosensor coupled with needle of a mode to carry out reliably repeatedly adopt and the same size and dimension of ball pen, carry easily.For example also can be provided for hanging over the hook on the interior pocket such as chest pocket and Western-style clothes on the top of determinator.

And then this determinator is the lancet approximate same size with market sale, and possesses and be used to produce power to drive the mechanism of common puncture needle.As determinator, can guarantee to be used for to make operability and the durability that the mensuration of using the biosensor coupled with needle of tube mode can reliably be carried out repeatedly, and carry easily, determinator laterally slides in the introduction part that is positioned at the bottom by making the cartridge type biosensor coupled with needle, and the adapter that makes the terminal of biosensor and determinator is formed by connecting and is the state that can measure, then, for being driven, puncture imposes on tube inside, by spurring the preparation that lever finishes to measure, afterwards, push the switch of puncture start button, make it according to puncture, blood sampling, the order of measuring is moved automatically, finally derives measurement result.

More be described in detail an example of characteristics on the assay device structures.This determinator is puncture needle drive division and determinator integrally, the drive division that the puncture needle drive division comprises shank part, puncture start button portion, is made of elastomers such as springs.On the other hand, the basic structure of determinator portion comprises: the display part of the measurement section of the electrical value of tube introduction part, adapter, electrochemical gaging circuit, memory section, guidance panel, measurement biological sensor electrode and the measured value of demonstration measurement section, and then, also can carry for example bluetooth (login trade mark) of radio as wireless means.Owing to utilizing this slide construction, therefore, can improve as the determinator integral intensity tube being remained on reliably acceptance puncture driving under the state.

Owing to utilizing this slide construction, therefore, can improve as the determinator integral intensity tube being remained on reliably acceptance puncture driving under the state.

The puncture of determinator drive can be tube top along the mechanism that returns rapidly after vertical direction is knocked, and then preferably have the mechanism that can adjust puncture subject skin depth.In addition, in order to carry out puncture reliably to subject skin, also can be in the bottom of determinator, for example near the contact with tube is the bottom of adapter, Non-slip material is installed.At this moment, the Non-slip material of rubber system preferably.Equally, the puncture start button also can carry out the modification of this Non-slip material.And, in addition can also have following function, that is, drive the lever interlock and make described illumination functions auto-action, the function that the light that shines from the blood sampling introduction part is partly shone to the puncture of subject with pulling determinator puncture.Thus, comprise that visually impaired person can both puncture, take a blood sample, measure this a series of operation reliably.

Other lighting mechanisms as determinator of the present invention also can possess following mechanism, by measuring illumination automatically by the photodetectors such as photodiode that are built in determinator, shine puncture part and display part as required.Thus, even in the dark or under the dark a little environment such as lavatory, also needn't specially open light switch and measure.In addition, some the specific operation such as operation by the accessing of data just, display part plays a role this mechanism, can further improve the convenience of determinator of the present invention.But this mechanism easily of packing into might increase power consumption.As countermeasure is that determinator is set at the system that can charge, and then possesses solaode and can charge.In addition, also can possess booster battery in inside.

There is no particular limitation as the measuring method of determinator measurement section, can use current potential stepping chronoamperometry, coulometry or cyclic voltammetry etc.

In addition, also can possess various aligning gears.As the important correction in the blood sugar detection temperature correction and hematocrite value are arranged.Because the activity of the enzyme that uses in the blood sugar detection is subjected to Temperature Influence easily, particularly when shortening minute, temperature correction in most cases is important.In addition, hematocrite value also is to the influential key factor of blood-sugar level measuring.The mensuration of hematocrite value for example can also be inferred according to the translational speed of taking a blood sample in the biosensor.As its mechanism, for example use three electrodes, obtain by two the moment beginning to take a blood sample and the moment by the 3rd, also can calculate the translational speed of blood sampling according to its time difference and interelectrode distance.

In addition, need to suppress since biosensor batch etc. the measured value variation that causes of difference.At this moment, as long as just possess carry out gauged function automatically to every batch can.

For the blood glucose value data that the management and utilization said mechanism is obtained more accurately, also need management constantly accurately.At this moment, the radio clock element that also can in determinator, pack into and cheaply buy easily recently.Thus, can accurately store past data under the management constantly.

As other mechanisms of management determination data, the data that can enumerate to other medium move.As its example, have by data send with cable and data from determinator to the mechanism that PC etc. sends, in addition, also can consider to use communication agencies such as radio.By this communication agency is applied on the determinator, can eliminate the trouble of wired connection etc.

And then, by vocal guidance and sound identifying function are installed on determinator, then can make to comprise that health has numerous users of the user of obstacle to recognize the benefit that it is easy to use.About vocal guidance, for example, when reality uses determinator to measure blood glucose value, its operating procedure and matters needing attention etc. are instructed user in real time, can reduce the frequency that failure is gone up in operation like this.And then, can carry out accessing for the report of measurement result and past data etc. by sound.

In addition, sound identifying function can improve operability too.For example, pressing operation button and only also can carry out illumination of the accessing of past data, site of puncture etc. not by sounding to determinator.In addition, at display part, preferably at the laying state that makes determinator when vertically placing or laterally placing, display part is automatically switched to vertically or laterally according to its modes of emplacement.Perhaps, preferably possess following function, that is, switch demonstration continuously by placement angle according to determinator, and the function of all the time literal of picture etc. being expressed abreast.Utilize this function, the literal modes of emplacement that user needn't corresponding display part moves to aim at sight line.

As mentioned above, biosensor coupled with needle of the present invention, tube and biosensor coupled with needle do not limit user with determinator, that is, can generally use.

Biosensor coupled with needle, tube and biosensor coupled with needle determinator for embodiment of the present invention at length describe with reference to accompanying drawing respectively, as long as but be no more than aim of the present invention, the present invention is not limited to following embodiment.

Fig. 1 represents the example of biosensor structure figure of the present invention.The exterior side of Fig. 1 (a) expression substrate 1 is pasted with puncture film 5 on the substrate 1.The inner face side of Fig. 1 (b) expression substrate 1 disposes two electric conductors 3,3 on the substrate 1, through hole 4 is positioned at the center of substrate width direction.2 exterior side is covered in Fig. 1 (c) expression, and the center of lid 2 is provided with through hole.2 inner face side is covered in Fig. 1 (d) expression, and lid 2 is provided with the bond layer of using as dottle pin 8, is provided with through hole 4 and non-dottle pin part 6 in the part that bond layer 8 is not set.Substrate 1 side of the biosensor 42 after Fig. 1 (e) expression assembling.Equally, lid 2 sides of the biosensor 42 after Fig. 1 (f) expression assembling.At this, the through hole 4 shown in Fig. 1 (c) becomes puncture blood collecting mouth 10, and two electric conductors 9,9 that do not have tegmentum 2 to cover become terminal respectively.In addition, from cover 2 left and right sides substrates 1 that lean out hang over after shown in the sender unit cap holder 33 (not shown) of puncture needle housing 61 bottoms on, be arranged for and prevent because the impact during puncture and biosensor body 42 comes off from puncture needle housing 61.A-A ' the section of Fig. 1 (g) presentation graphs 1 (f).Be provided with puncture film 5 above the substrate 1, downward from substrate 1, electric conductor 3, as the bond layer 8 of dottle pin with cover 2 to connect road 12 with puncture needle be that the boundary is divided into two parts.In Fig. 1 (g), puncture needle connects puncture film 5 from the top of puncture film 5, and connects after road 12 is projected into puncture blood collecting mouth 10 by puncture needle, turns back to original position.In this process, stop up or diminish by the through hole that makes the puncture film of opening 5, can not hinder capillarity, the blood sampling that flows into from puncture blood collecting mouth 10 is imported to the electrode reaction portion 13 that is positioned on the carrying path 7 of taking a blood sample.What Fig. 1 (h) represented equally is B-B ' profile.Puncture needle connects the blood sampling of puncturing film 5 and obtaining and is taken into from the puncture blood collecting mouth, and delivers to electrode reaction portion 13.The biosensor of Fig. 1 shown in Fig. 1 (h), is provided with air outlet 11 on biosensor top.

Fig. 2 is in biosensor shown in Figure 1, is used for importing effectively blood sampling and is difficult for being taken into the structure of required above body fluid.Its characteristics show three parts shown below.

(1) set the diameter of lid 2 through hole 4 than the size of substrate 1 big (relatively (b) and (c)).Thus, entering into the blood sampling of covering 2 blood sampling mouth 10 utilizes its surface tension to arrive substrate 1 easily.

(2) to move to electrode reaction portion 13 rapidly in order making, a part of width of the blood sampling carrying path 7 of electrode reaction portion 13 sides to be increased (with reference to (d)) from the blood sampling of puncture blood collecting mouth 10 inflows.Like this, adopt from puncture blood collecting mouth 10 towards the pyramidal structure that electrode reaction portion 13 narrows down, the blood of adopting from the puncture blood collecting mouth is moved to electrode reaction portion 13 easily by the carrying path 7 of will taking a blood sample.

(3) pass through the narrowed width of air outlet 11, and be difficult for being taken into required above body fluid (with reference to (d)).

Fig. 3 imports the example (with reference to Fig. 3 (c), (f), (g), (h)) that guide 14 is installed in the puncture blood collecting mouth outline of biosensor shown in Figure 1 to blood sampling.Blood sampling imports guide 14 and is not particularly limited on material, but if may be then the rubber-like material that is difficult for skidding preferably.By this guide is installed, can capture the puncture part sensuously, and when puncture skidproof effect work, and can push the skin of subject, like this, make the portion's of being punctured protuberance, easily puncture blood collecting.

Fig. 4 imports puncture blood collecting mouth 10 example (with reference to Fig. 4 (c), (f), (g), (h)) on every side that guide 14 is installed in biosensor shown in Figure 1 to blood sampling.Blood sampling imports guide 14 and is not particularly limited on material, but if may be then gel preferably.By this guide is installed, same with biosensor shown in Figure 3, can capture the puncture part sensuously, and puncture the time can improve skidproof effect and with the connecting airtight property of skin.Like this, the body fluid that the portion of being punctured is taked is impregnated into and covers 2 parts, avoids the waste of taking a blood sample.And then, if adopt the biosensor shown in this figure, owing to can improve connecting airtight property with skin as described above like that, therefore, the negative pressure that can utilize puncture needle housing 61 (not shown) to be produced attracts blood sampling, and the blood that collects is transported to electrode reaction portion 13 rapidly.Biosensor shown in this figure adopts following structure, in order to attract blood sampling, make and clip puncture film 5 between the table side of substrate 1 and the puncture needle housing 61 and connect airtight, at this puncture film 5 through hole (with reference to Fig. 4 (a), (e), (g), (h)) of air outlet 11 usefulness is set, in puncture needle housing 61, sending into by the aerofluxus of vacuum suction.Therefore, the puncture film at this moment and the connecting airtight property height of substrate for example also can use artificial skin.

Fig. 5 is the shrink-wrap example of biosensor shown in Figure 4.Fig. 5 (a) is provided with the face side that blood sampling imports the lid 2 of guide 14 around being illustrated in puncture blood collecting mouth 10.The state of Fig. 5 (b) expression terminal 9 usefulness protecting film 17 coverings on from the face side of the lid of the biosensor shown in Fig. 4 (f) 2 to substrate 1.Illustrated A-A ' section among Fig. 5 (c) presentation graphs 5 (b).Protecting film 17 is being fixed by powerful adhesive linkage 18 to the scope of the folding line 15 of protecting film 17 from covering 2 face side tops.Other parts of protecting film 17 are not provided with bond layer (non-bonded part 20) especially, but by simple and easy bonding with the gel blood sampling importing guide 14 of a feature of biosensor shown in Figure 4, and make blanketing lid puncture blood collecting mouth 10.The biosensor of protected film 17 shrink-wraps of Fig. 5 (d) expression make use-case.By protecting film 17 is rolled onto folding line 15, biosensor is become measure spendable state.Since after use by protecting film 17 being pasted again and can being packed once more, so avoided infected danger.

Fig. 6 is illustrated in the example that biosensor air outlet 11 shown in Figure 4 is provided with aeration film 60.In substrate 1 rear side of Fig. 6 (a), the puncture film 5 with external pasting aeration film 60.Through hole 4 shown in aeration film 60 coverage diagrams 6 (b).This through hole 4 becomes air outlet 11 as can be seen at Fig. 6 (h).The feature of the biosensor shown in this figure is identical with biosensor shown in Figure 4, the negative pressure that produces by puncture needle housing 61 puncture backs attracts blood sampling, and send into to biosensor inside, but at this moment worried owing to the superfluous required above body fluid inflow that causes is limited in before the aeration film that is arranged at air outlet 11.

Fig. 7 and Fig. 8 represent the most basic biosensor structure of the present invention shown in Figure 1 improved example in addition.Biosensor the inner air-tight state that keeps of biosensor, had adopted the structure of inner reagent state stable for extended periods of time before using.Fig. 7 (a) is on the substrate 1 shown in Fig. 1 (a), is that extend plate member on the boundary to upper direction with groove 15.Fig. 7 (b) is arranged to not stride across electric conductor 3 to the groove on the substrate 1 15.Lid 2 shown in Fig. 7 (c) is to be that extend plate member on the boundary to upper direction with groove 15 on the lid 2 shown in Fig. 1 (c) too.Fig. 7 (d) is arranged to stride across non-dottle pin part 6 to the groove 15 on the lid 2.Fig. 7 (e) and Fig. 7 (f) represent the substrate 1 of biosensor body 42 respectively and cover 2 sides.Fig. 7 (g) and Fig. 7 (h) expression A-A ' section and B-B ' section.Shown in Fig. 7 (h), groove 15 is configured to 7 disjunctions of blood sampling carrying path.

Fig. 8 represents biosensor shown in Figure 7 is formed the example of the package body state of being packed by protecting film.Fig. 8 (a) expression is packed cap 2 outsides of biosensor 42 with protecting film 17 example.A-A ' the section of Fig. 8 (b) presentation graphs 8 (a).Among this figure, on the protecting film 17 that uses, newly be provided with the layer 19 that can paste stripping.At this, what is called can be pasted stripping layer 19, and is different with powerful adhesive linkage 18 employed bonding agents, is meant to carry out the weak adhesive linkage of bonding force bonding and that peel off repeatedly.In addition, Fig. 8 (c) is that the A-A ' section with Fig. 8 (b) is a basic representation with the use-case that makes of the biosensor of protecting film 17 shrink-wraps.Like this; by the biosensor edge being arranged on the V font groove disjunction of 2 ones on substrate 1 and lid; the airtight medicated cap portion 16 of not containing electrode pattern is come off, and air outlet 11 is opening again, and peels off by pasted stripping layer 19 part of protecting film 17 puncture blood collecting mouth 10 also is opened.At this moment, the protecting film 17 that is fixed on airtight medicated cap portion 16 by powerful adhesive portion 18 is also correspondingly taken off from biosensor body 42 as pick off separating part 57.This pick off separating part 57 can be pasted again as originally and pack use again after mensuration uses biosensor body 42.

Fig. 9 represents the example of cartridge type biosensor coupled with needle structure chart.In addition, illustrated biosensor is a biosensor shown in Figure 1.The exploded view of Fig. 9 (a) expression biosensor coupled with needle 21.It is puncture needles and the bottom is the structure of biosensor that biosensor coupled with needle 21 forms tops.Puncture needle 26 is fixed on the puncture needle fixing base 24, is provided with at its housing to be used to avoid the helical spring guide 25 that contacts and limit the helical spring direction of motion with helical spring 27.In addition, have puncture needle holder substrate 30 in the bottom of puncture needle 26, this substrate is provided with the puncture needle guide 28 that is used for from inboard protection puncture needle through hole 4 and puncture needle track.Space between puncture needle holder 22 and puncture needle holder substrate 30 contains the needed parts of puncture, forms puncture needle housing 61.

Be provided with two holders that are used to prevent that biosensor 42 comes off because when puncture impacts in the part of puncture needle housing below 61.Fig. 9 (b) and Fig. 9 (c) represent respectively from above or below the situation that sensor base plate 1 (32) is embedded into state the sensor base plate holder 31 seen, Fig. 9 (d) and Fig. 9 (e) represent respectively from above or below the situation that sender unit cap 34 is embedded into state the sender unit cap holder 33 seen.Shown in Fig. 9 (b)～(e), these holders are following structures, and biosensor comes off in order to prevent to puncture, and can embed variform sensor base plate 32 and sender unit cap 34 according to profile.Under fixing, sender unit cap holder 33 is set, like this, is supported by sender unit cap holder 33 from covering 34 substrate portion that lean out than the sensor base plate holder 31 that covers the big sensor base plate of 34 sizes 32.This supporting prevents biosensor 42 comes off because when puncture impacts the effect except having, when the assembling biosensor coupled with needle, make biosensor 42 to these holders slide embed also convenient.Shown in Fig. 9 (b) and Fig. 9 (c), in order to embed secure fixation and not come off by sensor base plate 32 being slided to sensor base plate holder 31, sensor base plate holder 31 is provided with sensor base plate fixture 35.The assembling example of the biosensor coupled with needle 21 that Figure 10 (a)～Figure 10 (b) expression is shown in Figure 9.

Figure 11 represents Fig. 7 and biosensor 42 shown in Figure 8 situation as the assembling of coupled with needle pick off.Figure 11 (a) and Figure 11 (b) represent respectively from above or below the situation that sensor base plate 32 is embedded into state the sensor base plate holder 31 seen, Fig. 9 (c) and Fig. 9 (d) expression from above or below the situation that sender unit cap 34 is embedded into state the sender unit cap holder 33 seen.Shown in Figure 11 (a) and Figure 11 (b),, need to use the fixture 35 of sensor base plate 32 usefulness to fix at four positions for the biosensor of this shape is accommodated and is fixed in the biosensor coupled with needle tube.The biosensor that is in packed state 42 that Figure 11 (e) expression is seen from the below is housed in the situation of an internal state.At this, sensor base plate 32 outer frame parts during dotted line 40 expression perspectives.Also be housed in the holder as can be seen from this dotted line 40, the impact energy during for puncture is fully born the biosensor slidingtype.Figure 11 (f) expression is opened the situation that biosensor is packed from the state of Figure 11 (e), at this moment, the pick off separating part 57 that takes off is illustrated in Figure 11 (g).If adopt this mode, then after using biosensor, with regard to the packing again of pasting again easily.

Figure 12 is the figure of the position relation of stereo representation biosensor coupled with needle 21 and external drive 41.As shown in the drawing, form external drive 41 and enter into structure in the external drive introduction part 23 that puncture needle holder 22 heads open, be the structure of the top transmission of the puncture needle fixing base 24 of external drive 41 to puncture needle housing 61 in.

Figure 13 represents the situation of the biosensor coupled with needle shown in Figure 9 21 seen from the side.Figure 13 (a) expression is the state of the head part of the biosensor body of biosensor coupled with needle 21 towards the front, and Figure 13 (b) represents profile at this moment.The state of the biosensor body of the biosensor coupled with needle 21 that Figure 13 (c) expression is seen from the side, Figure 13 (d) expression profile at this moment.

Figure 14 represents biosensor coupled with needle shown in Figure 13 21 and the action that puncture drives altogether.From these profiles as can be seen, among Figure 14 (b), puncture needle 26 is positioned at the center of puncture needle housing 61, is provided with the perforation road of puncture needle down across puncture film 5 at it.Figure 14 (d) is expressed as follows state, drives the front end that makes puncture needle owing to being subjected to puncturing and moves downwards, and after connecting biosensor, it is outside only to be projected into tube in short time.

Figure 15 represents the retractility film is applied to the example of biosensor coupled with needle 21.Among Figure 15 (a), with different can being listed below structurally of the biosensor coupled with needle 21 shown in Fig. 9 (a), utilize bonding agent that retractility film 58 is fixed on puncture needle housing 61 tops, in puncture needle housing 61, be provided with air pressure inside adjustment check-valves, be provided with the through hole that blood sampling attracts usefulness at puncture needle holder substrate 30, shown in Figure 15 (b)～(e), can pack biosensor, and can utilize the negative pressure that produces in the puncture needle housing to take a blood sample to attract etc.

Figure 16 represents to be driven by puncture in the airtight type tube shown in Figure 15 the action of the inside that causes.The inside of the airtight type tube before Figure 16 (a) expression is used.Packing 17 and puncture that biosensor is opened in Figure 16 (b) expression drive situation about working.As shown in the drawing, puncture needle 26 connects puncture films 5, biosensor body 42 and outstanding to the outside.At this moment, in puncture needle housing 61 inside,, carry out the discharging of inner air by check-valves along with the rapid rising of air pressure.

Figure 17 enumerates the airtight type tube that uses the retractility film shown in Figure 15 (a) is carried out improved example.Among Figure 15 (a), use helical spring, and among Figure 17, substitute and use helical spring but only use retractility film 58 as elastomer.That is, beyond the top of puncture needle housing 61, by retractility film 58 also is fixed on the puncture needle holder substrate 30, and do not need helical spring.This is that retractility film 58 became the longest state of stretching, extension, just becomes on the contrary to be used to make the restorative power of puncture needle when puncture needle was projected into the outside owing to driving when the utilization puncture.Figure 17 (a) expression is fixed on situation on the puncture needle fixing base 30 to a retractility film 58, and Figure 17 (b) expression clips the situation of puncture needle thigh top substrate about in the of 30 that be fixed on to two retractility films 58 respectively.

Figure 18 is the profile of the airtight type tube shown in Figure 17 (a), the state before Figure 18 (a) expression is used, and packing 17 and puncture that biosensor is opened in Figure 18 (b) expression drive situation about working.

Figure 19 is the profile of the airtight type tube shown in Figure 17 (b), the state before Figure 19 (a) expression is used, and packing 17 and puncture that biosensor is opened in Figure 19 (b) expression drive situation about working.

Figure 20 represents to use that biosensor coupled with needle tube of the present invention is used to measure has the example of the determinator that puncture drives.Figure 20 (a) represents the state before the tube 21 importing determinators 43.For this figure determinator is described.This determinator 43 comprises: the introduction part 44 of biosensor coupled with needle tube 21, puncture drive shank part 45, guidance panel 46, the adapter portion 49 of biosensor terminal and the start button 50 that punctures of usefulness.Guidance panel 46 is provided with display part 47 and action button 48, and puncture start button 50 is provided with Non-slip material 51.Figure 20 (b) expression imports and spurs superposed shank part 45 to pick off tube 21 to determinator 43, the power supply of connection determinator and enter into the state of mode determination.At this moment the literal of Xian Shiing is the direction that reads easily by being used for the automatic switchover mode action identical with the determinator placement direction.Figure 20 (c) is the situation of pick off tube 21 after determinator 43 imports from horizontal expression.As shown in the drawing, be provided with hook 63 in the rear side of display part, easily the determinator body is housed in chest pocket and the interior pocket etc.Situation when Figure 20 (d) expression is seen pick off tube 21 and determinator 43 from the below.The biosensor 42 that pick off tube 21 is possessed is structures that blood sampling importing guide 14 are installed in puncture blood collecting mouth 10 outlines shown in Figure 3.Be that the bottom of pick off tube introduction part 44 is provided with and is used for making the position of determinator and skin not produce the Non-slip material 51 of dislocation when puncture in the bottom of determinator.

Figure 21 represented to implement shrink-wrap pick off tube 21 make use-case.Among Figure 21 (a), the medicated cap 52 that these pick off tube 21 usefulness can be taken off and covering on the top of puncture needle housing 61 is implemented the packing of protecting film to biosensor 42.Fig. 7 and hermetic type biosensor shown in Figure 8 are installed in the pick off tube 21.Figure 21 (b) expression is taken off the separating part 57 of the band protecting film of medicated cap 52 and biosensor 42 from pick off tube 21, and the state before determinator 43 imports.Figure 21 (c) expression is installed to pick off tube 21 on the determinator 43, the switch of connection display part and become the state that can measure.Figure 21 (d) expression is taken out the pick off tube of measuring after using 21 from determinator 43, and can pack and depleted state again.

Figure 22 represent enforcement shown in Figure 21 another of pick off tube 21 of shrink-wrap make use-case.Shown in Figure 22 (a),, being installed in the top of puncture needle housing 61, and connect with taking off curium with the same medicated cap 53 of Figure 22 on pick off tube 21 tops.Figure 22 (b) expression is opened medicated cap 53 and state before determinator embeds.Figure 22 (d) expression is taken out the pick off tube of measuring after using 21 and can pack and depleted state again from determinator 43.Owing at this moment form the structure that medicated cap 53 can not unload from puncture needle housing 61 by taking off curium, so after use, can not lose medicated cap.

Figure 23 and Figure 24 represent that another of pick off tube 21 of having implemented shrink-wrap with protecting film 17 makes use-case.What protecting film 17 shown in Figure 23 was represented is the mode of pasting stripping from tube, and what protecting film 17 shown in Figure 24 was represented is a part and the powerful bonding mode of tube.Employed biosensor 42 is with shown in Figure 22 identical.

Figure 25 be illustrated in puncture needle housing 61 tops implement retractility film 58 pick off tube 21 make use-case.If adopt this pick off tube 21, then the only operation by the protecting film 17 of biosensor 42 is peeled off before use just can enter into mensuration the most simply.

Figure 26 represents biosensor coupled with needle of the present invention to be installed in the determinator and determinator is contacted with the finger tip of subject, pushes the state that punctures start button 50 and enter into the mode determination after the puncture.As shown in the drawing, the picture of determinator is held horizontally and shows, the literal in the display frame forms the state of easy identification.

Figure 27 is with the situation in the pick off tube in the measurement operation of representing determinator shown in Figure 26 along the section of biosensor 42 length directions 21.At this, employed puncture unit is puncture unit shown in Figure 9, and biosensor 42 is arranged on air outlet 11 on the extended line of blood sampling carrying path 7, imports guide 14 with blood sampling on the outline of puncture blood collecting mouth 10.The figure shows by finger 54 is pressed on the determinator 43, import the situation that guide 14 makes the cutaneous protuberance of predetermined puncture part and utilize to take a blood sample.Under this state, when driving the puncture drive division 41 of determinator, then puncture needle 26 is driven downwards, connects puncture film 5, biosensor body 42 and outstanding to finger.Then, puncture needle 26 turns back to the origin-location, and openings diminishes puncture film 5 owing to the characteristics of its material, simultaneously, flow into the puncture blood collecting mouth from the body fluid of pointing (blood).

Figure 28 is the use-case that makes of using the pick off tube 21 shown in Figure 15 represented along the profile of biosensor 42 length directions.This pick off tube 21 is assembled with: by the puncture needle housing 61 of retractility film 58 coverings and the biosensor by attracting to take a blood sample.Be provided with check-valves 59 at this illustrated puncture needle housing, biosensor 42 has the structure that can take a blood sample by attracting.And the blood sampling of the gel of the puncture blood collecting mouth 10 by being installed in biosensor imports guide 14 and improves connecting airtight property with skin, becomes the structure of can high efficiency taking a blood sample.

Figure 29 represents the biosensor 42 that air outlet 11 is provided with aeration film 60 is assembled into example in the pick off tube 21 shown in Figure 28.Make and utilize the blood sampling that attracts to be sent in the pick off to rest on the aeration film 60.Can prevent to be taken into required above blood sampling by this mechanism.

Figure 30 is illustrated in the mensuration example of dark place.As shown in the drawing, in the dark determinator is lighted the backlight of display part automatically, illuminates the light of puncture portion from puncture blood collecting mouth 10.

Figure 31 has represented to assemble the accepting box 56 of the pick off tube 21 of the different biosensors 42 of shape separately with Figure 32.10 pick off tubes 21 for example can be accommodated in front and back in this box inside, by opening closing cap 53, can take out the pick off tube.

Figure 33 represents the example of biosensor structure figure of the present invention.Figure 33 a) represents the component parts of biosensor respectively, from begin to represent to cover 101, as the bond layer 105 of dottle pin 102 and resist layer 106, substrate 103.The centrage that covers 101 upper edge long axis directions is respectively opened the through hole 104 that the compartment of terrain is provided with two places ellipse and circle.Described two through holes become the perforation road of puncture needle respectively and are used for biosensor is fixed on location hole on puncture needle portion-biosensor holder.Dispose electrode and the electric conductor 7 that becomes terminal on the substrate 103.Figure 33 b) plane graph of the biosensor of the parts of Figure 33 shown in a) has been assembled in expression.As shown in the drawing, on the electric conductor 107 that is positioned on the substrate 103, be placed with and cover 101, the electric conductor 107 that exposes from the right-hand member of substrate 103 becomes terminal 111, the bond layer 105 of dottle pin 102 is exposed at circular through hole 104 places, oval-shaped through hole 104 is formed for puncture needle and uses perforation road 108 by the puncture that cap arrives the blood sampling mouth, and its periphery forms puncture blood collecting mouth 112 and electrode reaction portion 113.Figure 33 c) be Figure 33 b) shown in the side view of biosensor.From begin to represent to cover 101, as the bond layer of dottle pin 102 and resist layer, substrate 103.Be formed with by by substrate 103 and lid 101 spaces that clip at the left end of biosensor, this part forms puncture blood collecting mouth 112, and at the right-hand member of biosensor, 101 substrate 103 formation terminals 111 covers in configuration.Figure 33 d) A-A ' section presentation graphs 33b).Among this figure, block 109 is as being used for biosensor being fixed on the location hole on puncture needle portion-biosensor holder and being provided with, adopt puncture needle to connect road 108, and make puncture needle run into the structure of the subject that connects airtight with puncture blood collecting mouth 112 by the puncture blood collecting mouth 112 that between substrate 103 and lid 101, forms by puncture needle.So long as the biosensor structure shown in above then has puncture needle and can not polluted by reagent, connect road 108 and can be from the characteristics of subject blood sampling by puncture needle.

Figure 34 connects the example that is provided with puncture film 134 on the road 108 at biosensor puncture needle shown in Figure 33.Figure 34 a-i) 101 front, Figure 34 a-ii are covered in expression) the expression back side.The puncture needle that covers 101 lower left connects road 108 and is punctured film 134 coverings.Figure 34 b) plane graph of the biosensor of the parts of Figure 34 shown in a) has been assembled in expression.As shown in the drawing, be provided with puncture film 134 in lid 101 lower left according to the mode that covers puncture needle perforation road 108, be provided with terminal at right-hand member.Figure 34 c) be Figure 34 b) shown in the example of biosensor side view, be provided with puncture film 134 to electrode reaction portion 113 tops from puncture blood collecting mouth 112.Figure 34 d) A-A ' section presentation graphs 34b) is with Figure 34 c) same, be provided with puncture film 134 to electrode reaction portion 113 tops from puncture blood collecting mouth 112, puncture needle is connected road 108 cover.Utilize this structure, even by the blood sampling that after puncture, also keeps the structure of puncture film 134, have to utilize capillarity swimmingly effect to the conveying of electrode reaction portion 113.

Figure 35 is provided with anti-skidding 137 example below biosensor substrate shown in Figure 33 103 left parts.Figure 35 a-i) surface of expression substrate 103, Figure 35 a-ii) the expression back side, below substrate 103 left parts, be provided with anti-skidding 137.Figure 35 b) plane graph of the biosensor of the parts of Figure 35 shown in a) has been assembled in expression.Figure 35 c) represent its side view, Figure 35 d) represent its profile.According to this structure, between the skin of biosensor coupled with needle and subject, be difficult for during puncture producing dislocation, can access the effect of can be safely and puncturing reliably and taking a blood sample.

Figure 36 represents the structure chart of puncture portion.Figure 36 a) represents that each component parts of puncture portion, puncture portion comprise that puncture needle portion 114, helical spring 115 and puncture needle connect road 108.At this, puncture needle portion 114 comprises external drive introduction part 117, helical spring fixed part 118, puncture needle supporting mass 119 and puncture needle 120, and puncture needle connects road 108 and comprises puncture needle holder 116, helical spring fixed part 118, puncture needle portion holder introduction part 121 and puncture needle portion holder block 122.Figure 36 b) be the assembly drawing of puncture portion 123, helical spring 115 is configured in puncture needle portion 114 and puncture needle connects between the road 108.At this moment, for fixing helical spring 115 reliably, be provided with the helical spring fixed part and connect on the road 108 at puncture needle portion 114 and puncture needle.Figure 36 c) being the figure of the A-A ' section of expression puncture portion 123, is the structure that puncture needle portion 114 can slide in puncture needle connects road 108.

Figure 37 is the figure of expression puncture portion 123 action examples.Figure 37 a) represents that puncture portion 123 and external drive 124 configurations are routine.Figure 37 b) top of expression puncture needle portion 114 by be subjected to puncture from the outside drive 124 and puncture needle portion 114 connects the situation of road 108 inner slide, Figure 37 c at puncture needle) utilize helical spring counteracting force after the expression puncture and make puncture needle portion turn back to the situation of origin-location.

Figure 38 represents the structure of biosensor coupled with needle and makes use-case.Figure 38 a) represents to make biosensor coupled with needle to run into the site of puncture of subject 127, the example of side view when puncturing action.Biosensor coupled with needle comprises biosensor 125, puncture portion 123 and both fixed puncture needle portion-biosensor holders 126, have puncture portion 123 and be subjected to outside driving and helical spring is shunk, puncture needle 120 passes that puncture needle on the cap 101 that is arranged on biosensor 125 connects road 108 and the structure of thrusting the subject that is positioned at puncture blood collecting mouth 112 front ends.Figure 38 b) profile of mode presentation graphs 38a), puncture portion 123 is inserted by slidingtype and is installed in the puncture needle guide 135 of puncture needle portion-biosensor holder 126.At this, biosensor body 125 is fixed on the holder 126 by the block (protuberance) of puncture needle portion-biosensor holder 126 being embedded in the through hole (recess) 104 that is arranged at cap 101.

Figure 39 represents the action of puncture portion shown in Figure 37 as biosensor coupled with needle, represents a example to subject 127 punctures with front elevation.Figure 39 a) represents biosensor coupled with needle body 128 is configured in the state that subject 127 fingers are gone up the site of puncture, Figure 39 b) expression makes external drive 124 actions, and the front end of puncture needle 120 is thrust the state of subject, Figure 39 c) expression puncture back subject is hemorrhage, and its blood 129 is delivered to electrode reaction portion 113 from the puncture blood collecting mouth 112 of biosensor and entered the situation of reacting and measuring.

Figure 40 represents the action of puncture portion shown in Figure 37 as biosensor coupled with needle, represents a example to subject 127 punctures with side view.Figure 40 a) represents biosensor coupled with needle body 128 is configured in the state that subject 127 fingers are gone up the site of puncture, Figure 40 b) expression makes external drive 124 actions, and the front end of puncture needle is thrust subject and begins hemorrhage state, Figure 40 c) expression puncture back subject is hemorrhage, and its blood 129 is delivered to electrode reaction portion from the puncture blood collecting mouth of biosensor and entered the situation of reacting and measuring.At this moment, connect on the road, blood sampling is carried out more swimmingly by the puncture needle that puncture film shown in Figure 34 is arranged on biosensor.

Figure 41 represents biosensor coupled with needle 128 of the present invention is housed in state in the housing 130.Figure 41 be expression a) biosensor coupled with needle 128 be housed in dispose in the housing 130 profile.Upper shed portion 138 and under shed portion 139 that housing 130 has determinator importing guide 131, contacts with the introducing port of puncture driving 124 are by fixing puncture needle portion-biosensor holder 126 and housing 130 and biosensor coupled with needle 128 being carried out interior bag.The terminal 111 of biosensor is connected with adapter 141 in being arranged on housing 130, and 142 promptly is connected to the terminal for connecting 111 that is arranged on determinator with the outside of housing 130 by connecting up.Infra peristome 139 has the housing protuberance 136 of biosensor, and thus, user just can be in the site of puncture of sensuously grasping subject.At this moment, also can be arranged on anti-skidding portion on the protuberance 136 like that as shown in figure 35.Figure 41 b) side view of expression housing 130.Among this figure, below importing with guide 131, determinator is provided with the terminal 111 that is used to connect determinator.Figure 41 c) front elevation of expression housing 130, terminal 111 all is configured on the equal height with both sides.Figure 41 d) is the plane graph of housing 130.Center in upper shed portion 138 is provided with: the top of the external drive introduction part 117 of the puncture needle portion that the outside puncture of acceptance drives, this is outside equipped with the determinator importing guide 131 that is wound on upper shed portion 138 circumference.Figure 41 e) is the ground plan of housing 130.The protuberance 136 of biosensor front end is configured in the center of under shed portion 139, and portion disposes puncture needle and connects road 108 in the central, disposes puncture needle 120 in inside according to the mode that vertically moves with respect to tested physical ability.According to this structure, puncture needle 120 moves on the vertical direction of housing 130, can thrust subject right by the puncture driving 124 that is subjected in vertical direction.

Front elevation when Figure 42 represents to be assemblied in biosensor coupled with needle housing 130 on the determinator 132 possesses puncture at determinator 132 and drives 124.And, form following structure, that is, corresponding determinator imports the shape with guide 131, and housing introduction part 140 is set on determinator 132, with assembling shell 130 securely, and determinator 132 is contacted with the terminal 111 of housing 130.

Figure 43 represents an example of biosensor coupled with needle housing 130 packings.Figure 43 a) represents the upper shed portion 138 of housing 130 and under shed portion 139 the two situations of packing with packaging medicated cap 133.Like this, the reagent that can prevent configuration in the biosensor is because dampness and direct sunlight and deterioration, and then, can also prevent that puncture needle is outstanding and the accident that causes in possible trouble.Figure 43 b) expression is taken off this packaging medicated cap 133 and the state that can use in mensuration.Figure 43 c) the biosensor coupled with needle housing package body after the following disposal has been implemented in expression, that is, pack again after the use, since puncture needle give prominence to the accident that causes and prevent trouble before it happens by the infection disease of sample liquid generation.

Though describe the present invention in detail with reference to specific embodiment, to those skilled in the art, can carry out various changes and correction without departing from the spirit and scope of the present invention.

The application has incorporated its content as reference at this according to the Japanese patent application (spy is willing to 2005-057286) of application on March 2nd, 2005 and the Japanese patent application (spy is willing to 2005-120478) of application on April 19th, 2005.

Claims

1. biosensor coupled with needle, wherein, be used to puncture needle that thrusts subject skin and take body fluid and the biosensor body formation one that is used to carry out body fluid analysis, the driving mechanism of this puncture needle by the outside drives and connects the biosensor body in vertical direction, and thrusts skin.

2. biosensor coupled with needle as claimed in claim 1, wherein, comprise: be arranged on by electrical insulating property substrate and the folded spatial dottle pin of lid, electrode, the blood sampling carrying path, electrode reaction portion, be used to be punctured the pin perforation and inject the puncture blood collecting mouth of blood sampling to lid, and possess the substrate of the film (puncture film) that through hole and pin can connect or the substrate that only constitutes in the position relative by the puncture film with the puncture blood collecting mouth, and, have and make puncture needle can connect the puncture needle breakthrough part of substrate and lid, and has an electrode reaction portion, effusive blood utilizes capillarity to be directed to the blood sampling carrying path from the puncture blood collecting mouth by lancet puncture subject skin in this electrode reaction portion, electrode reaction portion, the result who reacts for the reagent of determination object material in the blood and electrode reaction portion carries out electrochemical measurement, is used for biosensor body and the incorporate holder of puncture needle but also possess.

3. biosensor coupled with needle as claimed in claim 2 wherein, is arranged to make the puncture needle that moves at the puncture needle breakthrough part not contact with the reagent of electrode reaction portion.

4. biosensor coupled with needle as claimed in claim 2, wherein, being set for taper by the sample introducing port of the folded dottle pin of substrate and lid and the figure of air outlet.

5. biosensor coupled with needle as claimed in claim 2, wherein, the puncture film has the two-layer above multiple structure of unlike material.

6. biosensor coupled with needle as claimed in claim 2, wherein, the puncture film is the following thin film of thickness 100 μ m.

7. biosensor coupled with needle as claimed in claim 2 wherein, is provided with the mobile interlock of puncture needle at the baseplate part of biosensor and opens the gate of closing.

8. biosensor coupled with needle as claimed in claim 2 wherein, is being positioned at around the puncture blood collecting mouth that covers on the plane or outline has step difference, this step difference as sample introducing port guide.

9. biosensor coupled with needle as claimed in claim 2 wherein, shines the light of visible region to puncture position from the puncture blood collecting mouth before puncture.

10. biosensor coupled with needle as claimed in claim 2, wherein, the terminal tegmentum on the insulating properties substrate covers, and this lid has the fold line that can fold, so that outside terminal exposes.

11. biosensor coupled with needle as claimed in claim 2 wherein, is provided with the protecting film of can be bonding and peeling off at insulating properties substrate outer surface.

12. biosensor coupled with needle as claimed in claim 2, wherein, the portion boundary that contains electrode at the part that does not contain electrode of insulating properties substrate and insulating properties substrate has the cut-out line, and have by the part that does not contain electrode of insulating properties substrate from this boundary separation and the opening that air outlet is opened medicated cap portion.

13. biosensor coupled with needle as claimed in claim 2 wherein, can be pasted into original state with the package body that is made of medicated cap and protecting film after biosensor uses.

14. biosensor coupled with needle as claimed in claim 1 or 2, wherein, puncture needle is housed in and is used in the housing that vertical direction drives, and possesses to be used to make the puncture needle perforation biosensor that is driven by external drive mechanism and to make it turn back to the mechanism of origin-location behind puncture subject skin in the puncture needle housing.

15. biosensor coupled with needle as claimed in claim 1 or 2 wherein, is provided with the action guide consistent with the driving direction that is subjected to from the outside that is used to make puncture needle in the puncture needle housing.

16. biosensor coupled with needle as claimed in claim 1 or 2 wherein, is provided with the internal pressure guiding mechanism, this internal pressure guiding mechanism makes by external drive sharply applied pressure mitigation in the puncture needle housing of air-tight state.

17. biosensor coupled with needle as claimed in claim 16, wherein, making the demulcent mechanism of pressure is check-valves.

18. biosensor coupled with needle as claimed in claim 1 or 2 wherein, after puncturing by external drive, makes in the puncture needle housing that is in airtight conditions to become negative pressure, this negative pressure becomes the captivation that blood sampling is imported to carrying path.

19. biosensor coupled with needle as claimed in claim 1 or 2 wherein, possesses the aeration film at the needed air outlet of importing of taking a blood sample to biosensor.

20. biosensor coupled with needle as claimed in claim 1 or 2, wherein, puncture needle has the photocatalyst effect.

21. biosensor coupled with needle as claimed in claim 1 or 2 wherein, possesses the medicated cap that shrink-wrap is used on puncture needle housing top.

22. biosensor coupled with needle as claimed in claim 21, wherein, shrink-wrap links with the puncture needle housing by taking off curium with medicated cap.

23. biosensor coupled with needle as claimed in claim 1 or 2, wherein, described biosensor coupled with needle is the cartridge type biosensor coupled with needle.

24. biosensor coupled with needle as claimed in claim 23, wherein, described cartridge type biosensor coupled with needle is the shrink-wrap type that can pack again.

25. a biosensor coupled with needle barrier packaging body wherein, contains a plurality of claim 23 or 24 described biosensor coupled with needle tubes.

26. a biosensor coupled with needle determinator, it possesses: claim 23 or 24 described biosensor coupled with needle tubes; The biosensor coupled with needle tube introduction part that the biosensor coupled with needle tube is slided install; Catch the adapter portion of the signal of telecommunication of biosensor coupled with needle tube electrode; Measure the measurement section of electrical value by adapter portion; The operating surface board that is used to measure; The display part that shows the measured value of measurement section; Preserve the memory section of measured value; The drive division of puncture needle; The drive division shank part; And the puncture start button that makes puncture needle begin to puncture.

27. biosensor coupled with needle determinator as claimed in claim 26, wherein, the measuring method of measurement section is current potential stepping chronoamperometry, coulometry, cyclic voltammetry.

28. as claim 26 or 27 described biosensor coupled with needle determinators, wherein, the external drive mechanism of puncture needle possesses makes it turn back to the mechanism of origin-location after puncture needle is driven.

29., wherein, have the mechanism of the degree of depth that can adjust puncture subject skin as each described biosensor coupled with needle determinator of claim 26 to 28.

30. each described biosensor coupled with needle determinator as claim 26 to 29, wherein, drive the shank part interlock and make the illumination functions action with the puncture of pulling determinator, make from the puncture part of the rayed subject of blood sampling introduction part irradiation.

31. as each described biosensor coupled with needle determinator of claim 26 to 30, wherein, the mensuration of hematocrite value is to be undertaken by the translational speed of measuring in the biosensor.

32. the biosensor coupled with needle using method of determinator, be the using method of each described biosensor coupled with needle of claim 26 to 31 with determinator, it is characterized in that, the biosensor coupled with needle tube is installed on the determinator that possesses the puncture needle driving mechanism, become the state that to measure by the pulling shank part, the front end of determinator is contacted with subject, automatically puncture, take a blood sample, measure this a succession of operation by pushing puncture beginning switch, and show its result at the display part of determinator.

33. biosensor coupled with needle, it constitutes biosensor and puncture needle is formed one, described biosensor comprises electrical insulating property substrate and lid, is arranged on by described electrical insulating property substrate and covers folded spatial dottle pin, electrode and reagent layer, described puncture needle is used to thrust subject skin and takes body fluid, described biosensor coupled with needle is characterised in that to have a through hole of puncture needle at the cover of the formation blood sampling mouth that is arranged at biosensor long axis direction front end.

34. biosensor coupled with needle as claimed in claim 33 wherein, possesses film (puncture film) that pin can connect or opens the gate of closing with the mobile interlock of puncture needle at through hole.

35. biosensor coupled with needle as claimed in claim 33 wherein, is provided with anti-skidding portion below the edge of substrate portion that forms the blood sampling mouth.

36. biosensor coupled with needle as claimed in claim 33, wherein, puncture needle be configured to when being arranged at the through hole of biosensor cap not with substrate contacts.

37. biosensor coupled with needle as claimed in claim 33, wherein, puncture needle is configured to have 20 °～90 ° angle with respect to biosensor when connecting biosensor.

38. biosensor coupled with needle as claimed in claim 33, wherein, puncture needle is fixed by puncture needle portion holder.

39. as each described biosensor coupled with needle of claim 36～38, wherein, biosensor and puncture needle are fixed by puncture needle portion-biosensor holder.

40. biosensor coupled with needle as claimed in claim 33, it is installed in has the housing that is used for the tube portion that is connected with determinator.

41. biosensor coupled with needle as claimed in claim 40, wherein, the blood sampling mouth that is positioned at the biosensor coupled with needle front end is outstanding from housing.