JP4958275B2 - Needle integrated sensor - Google Patents

Needle integrated sensor Download PDF

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JP4958275B2
JP4958275B2 JP2007035931A JP2007035931A JP4958275B2 JP 4958275 B2 JP4958275 B2 JP 4958275B2 JP 2007035931 A JP2007035931 A JP 2007035931A JP 2007035931 A JP2007035931 A JP 2007035931A JP 4958275 B2 JP4958275 B2 JP 4958275B2
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needle
flow path
integrated sensor
path forming
hole
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JP2008200068A (en
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剛 藤村
秀明 中村
智子 石川
正男 後藤
征夫 輕部
貴彦 北村
信吾 改森
裕人 中嶋
宏 早味
俊史 細谷
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National Institute of Advanced Industrial Science and Technology AIST
Sumitomo Electric Industries Ltd
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National Institute of Advanced Industrial Science and Technology AIST
Sumitomo Electric Industries Ltd
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Priority to JP2007035931A priority Critical patent/JP4958275B2/en
Priority to US12/519,916 priority patent/US20100004559A1/en
Priority to EP07850734A priority patent/EP2098167A1/en
Priority to PCT/JP2007/074246 priority patent/WO2008075651A1/en
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Description

本発明は、ヒト等の被検体に針を突き刺して血液等の液体試料を採取し、その特性を簡易に分析する簡易型体液測定装置等に用いられるバイオセンサに関し、具体的には試料採取のための穿刺用針とセンサとを一体型にして、被検者自身が簡易に測定できるようにした針一体型センサに関する。   The present invention relates to a biosensor used in a simple body fluid measuring device or the like for collecting a liquid sample such as blood by piercing a subject such as a human and simply analyzing its characteristics. The present invention relates to a needle-integrated sensor in which a puncture needle and a sensor are integrated so that a subject can easily perform measurement.

従来より、ヒト等の動物に針を突き刺して血液等の体液を採取し、その特性を簡易に分析する簡易型体液測定装置としては、例えば、糖尿病患者が血糖値を測定する血糖値測定装置が実用化されている。   Conventionally, as a simple body fluid measuring device that punctures a needle such as a human to collect a body fluid such as blood and easily analyzes its characteristics, for example, a blood glucose level measuring device for a diabetic patient to measure a blood glucose level is used. It has been put into practical use.

現在実用化されている血糖値測定装置は、血液を排出させるための穿刺用針と、排出された血液を採取して電流値等に変換するセンサと、測定器とが、別体になった測定キットであるため、穿刺用器具を用いて皮膚に針を刺すことによって血液を排出させた後、測定器にセンサを取り付けて、センサのキャビティ内に、排出された血液を採取して測定している。   The blood glucose level measurement device that is currently in practical use has a puncture needle for draining blood, a sensor that collects the drained blood and converts it into a current value, etc., and a measuring instrument are separated. Because it is a measurement kit, blood is discharged by inserting a needle into the skin using a puncture device, then a sensor is attached to the measuring instrument, and the discharged blood is collected and measured in the cavity of the sensor. ing.

このように、穿刺用針と測定器及びセンサとが別体となっている測定キットでは、穿刺用針で血液を排出させた後、測定器に持ち替えて測定しなければならないため、被検者自身が血液を排出させて測定するには不便である。このため、測定器にセンサ及び穿刺用針を装着できる測定キットが望まれている。   In this way, in the measurement kit in which the puncture needle is separated from the measuring instrument and the sensor, the blood must be discharged with the puncturing needle and then transferred to the measuring instrument. It is inconvenient for oneself to drain blood and measure. For this reason, a measurement kit that can attach a sensor and a puncture needle to a measuring instrument is desired.

測定器にセンサ及び穿刺用針を脱着自在に取り付けることができるようにした測定キットとしては、特許文献1で提案されているランセット一体型センサを用いたものがある。
特許文献1に開示のランセット一体型センサは、具体的には、図11に示すように、電極パターン51が印刷され且つ反応試薬が塗布された基板50と、ランセット52を収容できる空間53を形成した基板54とを組み合わせてなるセンサ本体の前記空間53内にランセット52を収納し、外部の駆動手段で、前記空間53内の長手方向にランセット52を駆動することにより、ランセット52先端に取付けられた針52aを、センサ本体先端53aから出没可能としたものである。
As a measurement kit in which a sensor and a puncture needle can be detachably attached to a measuring instrument, there is a kit using a lancet integrated sensor proposed in Patent Document 1.
Specifically, as shown in FIG. 11, the lancet-integrated sensor disclosed in Patent Document 1 forms a substrate 50 on which an electrode pattern 51 is printed and a reaction reagent is applied, and a space 53 in which a lancet 52 can be accommodated. The lancet 52 is accommodated in the space 53 of the sensor body in combination with the substrate 54, and the lancet 52 is driven in the longitudinal direction in the space 53 by an external driving means. The needle 52a can be moved in and out from the sensor body tip 53a.

このようなランセット一体型センサを測定装置に装着し、センサ本体先端を被検体に押し当てた状態で、ランセット52を駆動して針52aを皮膚に突き刺す。これにより、血液が皮膚表面に排出し、更に、針52aをセンサ本体内の空間53に収納することに伴って、血液を当該空間53内に採取し、そこで試薬と反応して生じた電位差等を電極で検出している。   With such a lancet-integrated sensor attached to the measurement device, the lancet 52 is driven and the needle 52a is pierced into the skin with the tip of the sensor body pressed against the subject. As a result, blood is discharged to the skin surface, and further, the needle 52a is stored in the space 53 in the sensor body, so that blood is collected in the space 53, and the potential difference generated by reacting with the reagent there. Is detected by the electrode.

WO2002−056769WO2002-056769

しかしながら、このようなランセット一体型センサは、試料を収容する空間53内で針52aを駆動していることから、空間53のサイズは針52aの駆動に必要なサイズとなり、測定に必要な血液量が、センサと穿刺用針とが別体となっている測定キットよりも多くなる。このことは、針を太くする、あるいは針を深く突き刺すことになり、被検者の採取時の痛みを増大させることになる。また、センサ本体と針の駆動機構を一体型に備えたランセット一体型センサは、小型化が困難である。   However, since such a lancet-integrated sensor drives the needle 52a in the space 53 that accommodates the sample, the size of the space 53 is the size necessary for driving the needle 52a, and the amount of blood required for measurement However, it becomes more than the measurement kit in which the sensor and the puncture needle are separated. This makes the needle thicker or pierces the needle deeper, and increases the pain when the subject is collected. In addition, it is difficult to reduce the size of the lancet-integrated sensor provided with the sensor body and the needle drive mechanism in an integrated manner.

一方、特許文献1は、血液を収容するキャビティを、センサ本体内のランセット収納空間とは別に備えることも提案している。この場合、キャビティサイズは、ランセットとは無関係に設定することができるので、採取血液量の低減を図ることが可能になると考えられ得る。しかしながら、ランセットによる突き刺し位置とキャビティ入り口とが異なる位置に配設されているにもかかわらず、皮膚表面に排出された血液及び針に付着した血液を有効にキャビティ内に収容するための機構は、何等開示されていない。   On the other hand, Patent Document 1 also proposes providing a cavity for storing blood separately from the lancet storage space in the sensor body. In this case, since the cavity size can be set independently of the lancet, it can be considered that the amount of collected blood can be reduced. However, despite the fact that the piercing position by the lancet and the cavity entrance are arranged at different positions, the mechanism for effectively accommodating the blood discharged on the skin surface and the blood adhering to the needle into the cavity is as follows: Nothing is disclosed.

本発明は、以上のような事情に鑑みてなされたものであり、その目的は、穿刺用針をセンサに固定した針一体型センサとし、試料の反応空間(キャビティ)サイズ及び測定に必要な採取血液量の低減を図るとともに、針の突き刺し位置とキャビティ入り口とが離れた位置にあっても、皮膚表面に排出された血液を有効にキャビティ内に導入することができる針一体型センサを提供することにある。   The present invention has been made in view of the circumstances as described above, and an object of the present invention is to provide a needle-integrated sensor in which a puncture needle is fixed to a sensor, and to obtain a sample reaction space (cavity) size and sampling necessary for measurement. Provided is a needle integrated sensor capable of reducing blood volume and effectively introducing blood discharged to the skin surface into the cavity even when the needle piercing position and the cavity entrance are separated from each other. There is.

穿刺用針をセンサに固定した針一体型センサにおいては、被検者から血液等の液体試料を皮膚表面に排出するのに必要な突き刺しを行なうため、穿刺用針が突出した状態で固定されることになる。このため、穿刺用針の先端と試料反応空間の入り口とが離間した位置関係にならざるを得ないが、穿刺用針の先端から試料反応空間の入り口まで、液体試料が流動できる流路を設けることで解決が可能である。そこで、本発明者らは、穿刺用針の先端から試料反応空間の入り口まで、液体試料が流動できる流路を形成する流路形成体を取付けるとともに、当該流路を通って液体試料が有効に試料反応空間に導入される構成を種々検討し、本発明の完成に至った。   In the needle-integrated sensor in which the puncture needle is fixed to the sensor, the puncture needle is fixed in a protruding state in order to perform a puncture necessary for discharging a liquid sample such as blood from the subject to the skin surface. It will be. For this reason, the tip of the puncture needle and the entrance of the sample reaction space must be spaced apart from each other. However, a flow path through which the liquid sample can flow is provided from the tip of the puncture needle to the entrance of the sample reaction space. This can be solved. Therefore, the inventors attach a flow path forming body that forms a flow path through which the liquid sample can flow from the tip of the puncture needle to the entrance of the sample reaction space, and the liquid sample is effectively passed through the flow path. Various configurations introduced into the sample reaction space have been studied, and the present invention has been completed.

すなわち、本発明の針一体型センサは、被検体から液体試料を排出させる穿刺用針、前記液体試料が収容される反応部、及び該反応部の結果を検知する検知部を一体的に備えるとともに、前記穿刺用針、前記反応部、及び前記検知部が一体的に可動するように設けられている針一体型センサ本体と、前記被検体の当接部分から前記反応部への流路となる貫通孔が設けられ、該貫通孔に前記穿刺用針が内挿されている流路形成体とを備えた針一体型センサであって、前記貫通孔と前記流路形成体外とを連通する通気路が、前記流路形成体に設けられている。
That is, the needle-integrated sensor of the present invention, Ru integrally includes a detector for detecting reaction portion the puncture needle for discharging the liquid sample from the subject, wherein the liquid sample is contained, and the result of the reaction unit And a needle-integrated sensor main body provided so that the puncture needle, the reaction portion, and the detection portion are integrally movable, and a flow path from the contact portion of the subject to the reaction portion, A needle-integrated sensor provided with a flow path forming body in which the through hole is provided, and the puncture needle is inserted into the through hole, and communicates the through hole and the outside of the flow path forming body. A ventilation path is provided in the flow path forming body.

本発明の針一体型センサは、穿刺用針単独ではなく、針一体型センサ本体として駆動して、被検者の皮膚に突き刺し、液体試料を排出させるようにして用いられる。前記流路形成体の材質は特に限定せず、剛体であってもよいし、弾性体であってもよいし、粘弾性体であってもよいが、好ましくは、変形により、前記貫通孔の穿刺方向長さを変えて前記貫通孔から前記穿刺用針を出没可能にする弾性体又は粘弾性体で構成されている。流路形成体自体の弾性復元力で、皮膚に突き刺した穿刺用針を引き抜くことで、測定器には穿刺用針を突き刺すための駆動機構を備えるだけで済むからである。 The needle-integrated sensor of the present invention is used as a needle-integrated sensor main body, not a single puncture needle, and is pierced into the subject's skin to discharge a liquid sample. The material of the flow path forming body is not particularly limited, and may be a rigid body, an elastic body, or a viscoelastic body . It is composed of an elastic body or a viscoelastic body that changes the length in the puncture direction so that the puncture needle can be projected and retracted from the through hole. This is because, by pulling out the puncture needle that has pierced the skin with the elastic restoring force of the flow path forming body itself, the measuring instrument only needs to have a drive mechanism for piercing the puncture needle.

前記通気路は、前記貫通孔と前記流路形成体外とを連通するように設けられる限り、流路形成体のいかなる位置に設けてもよい。従って、前記通気路は、前記貫通孔を構成する当該貫通孔の周壁面の適宜位置に貫設された連通孔であってもよいし、前記センサ本体の取付け部分に凹設された凹部であってもよいし、また前記針一体型センサ本体をとりつけた状態で当該センサ本体と流路形成体との取付け部分に形成される隙間であってもよいし、被検体に当接した状態で、前記貫通孔と前記流路形成体外とが連通するように、流路形成体の被検体当接面に設けられた切り欠きであってもよいし、これらの組合わせであってもよい。   The air passage may be provided at any position of the flow path forming body as long as it is provided so as to communicate the through hole and the outside of the flow path forming body. Therefore, the air passage may be a communication hole penetrating at an appropriate position on the peripheral wall surface of the through-hole constituting the through-hole, or may be a recess provided in a mounting portion of the sensor body. It may also be a gap formed in the attachment part between the sensor body and the flow path forming body with the needle-integrated sensor body attached, or in a state in contact with the subject, It may be a notch provided on the subject contact surface of the flow path forming body or a combination thereof so that the through hole communicates with the outside of the flow path forming body.

好ましくは、前記通気路は、前記流路形成体におけるセンサ本体の取付け部分に設けられる。ここで、センサ本体の取付け部分とは、貫通孔に穿刺用針を内挿したときに、通気路が形成されていなければ、センサ本体先端部分と流路形成体とが接触していたであろう部分をいい、例えば、流路形成体がセンサ本体に接着、溶着などにより接合されるときはその接合部分をいい、嵌挿により取付けられる場合には嵌挿部分をいう。従って、前記取付け部分に前記通気路を設ける場合としては、例えば、前記流路形成体において針一体型センサ本体が取付けられる面(以下、「センサ本体取付け面」という)の一部を流路形成体外に連通するように切り欠く場合、前記センサ本体取付け面に流路形成体の外周面に至るまでの溝を設ける場合、センサ本体取付け面自体を空気の流出入ができるような粗面とする場合などが挙げられる。また、流路形成体とセンサ本体が嵌挿により取付けられる場合には、センサ本体先端の外嵌部分となる、当該流路形成体の壁面を貫通する連通孔によって、あるいは遊嵌の場合の流路形成体とセンサ本体との間のクリアランスによって、通気路を形成してもよい。   Preferably, the ventilation path is provided in a sensor main body attachment portion of the flow path forming body. Here, the attachment part of the sensor body means that when the puncture needle is inserted into the through-hole, if the air passage is not formed, the tip part of the sensor body and the flow path forming body are in contact with each other. For example, when the flow path forming body is bonded to the sensor body by bonding or welding, the bonding portion is referred to, and when the flow path forming body is attached by insertion, the insertion portion is referred to. Accordingly, when the ventilation path is provided in the mounting portion, for example, a part of a surface on which the needle-integrated sensor body is mounted in the flow path forming body (hereinafter referred to as “sensor body mounting surface”) is formed as a flow path. When notching so as to communicate with the outside of the body, when providing a groove extending to the outer peripheral surface of the flow path forming body on the sensor body mounting surface, the sensor body mounting surface itself is made rough so that air can flow in and out. Cases. In addition, when the flow path forming body and the sensor body are attached by insertion, the flow through the wall surface of the flow path forming body, which is an outer fitting portion of the sensor main body, or in the case of loose fitting The ventilation path may be formed by a clearance between the path forming body and the sensor body.

前記通気路が前記センサ本体の取付け部分に設けられる場合、前記通気路は、前記反応部入り口が前記通気路の途中又は前記通気路入り口の近傍に位置するように設けられることが好ましい。具体的には、前記反応部入り口が前記流路形成体に形成された貫通孔内に配置されている場合には、前記貫通孔に連通している前記通気路の入り口が前記穿刺用針よりも前記反応部入り口に近い位置となるように配設することが好ましい。また、前記反応部入り口が前記貫通孔内に配置されていない場合には、前記貫通孔から流路形成体外へ至る通気路の途中に前記反応部入り口が配設されるように、前記通気路を設けることが好ましい。   In the case where the air passage is provided in the attachment portion of the sensor body, the air passage is preferably provided so that the reaction portion entrance is located in the middle of the air passage or in the vicinity of the air passage entrance. Specifically, when the reaction part entrance is disposed in a through hole formed in the flow path forming body, the entrance of the air passage communicating with the through hole is more than the puncture needle. Also, it is preferable to arrange it so as to be close to the entrance of the reaction part. In addition, when the reaction part inlet is not disposed in the through hole, the vent path is arranged so that the reaction part inlet is disposed in the middle of the vent path from the through hole to the outside of the flow path forming body. Is preferably provided.

前記通気路には、液体流出防止機構が設けられていることが好ましい。液体試料の流路となる貫通孔と前記通気路とは連通しているので、当該通気路を通って液体試料が流路形成体外部へ漏出することを防止するためである。通気路に設けられる液体流出防止機構としては、例えば、前記通気路の途中に屈曲部を設けるだけでもよいし、液体流出防止のための防護壁を流路形成体に設けてもよい。   It is preferable that a liquid outflow prevention mechanism is provided in the air passage. This is to prevent the liquid sample from leaking out of the flow path forming body through the air passage because the through hole serving as the liquid sample passage and the air passage are communicated with each other. As a liquid outflow prevention mechanism provided in the air passage, for example, a bent portion may be provided in the middle of the air passage, or a protective wall for preventing liquid outflow may be provided in the flow path forming body.

また、貫通孔を通る液体試料が、前記通気路を流れるよりも前記反応部に優先的に流入されることが好ましく、このことは、前記貫通孔がセンサ本体取付け部分、さらには前記反応部入り口近傍に設けられている場合に特に求められる。液体試料を前記通気路よりも前記反応部に優先的に流入させることは、通気路入り口と反応部入り口のサイズ、通気路と反応部の入り口の位置関係などを適宜設定することによって達成することもできるが、好ましくは、前記反応部の入り口近傍に、界面活性剤が塗布されていることである。界面活性剤の塗布は、反応部入り口に限らず、液体試料を優先的に流入したい部分に施してもよい。   In addition, it is preferable that the liquid sample passing through the through-hole is preferentially flowed into the reaction part rather than flowing through the ventilation path. This means that the through-hole is attached to the sensor body and further to the reaction part entrance. This is particularly required when it is provided in the vicinity. The preferential flow of the liquid sample into the reaction section over the ventilation path is achieved by appropriately setting the size of the ventilation path entrance and the reaction section entrance, the positional relationship between the ventilation path and the reaction section entrance, and the like. However, it is preferable that a surfactant is applied in the vicinity of the entrance of the reaction section. The application of the surfactant is not limited to the reaction part entrance, and may be applied to a part where the liquid sample is to flow preferentially.

本発明の針一体型センサは、穿刺用針先端と離間して配設された反応部入り口に、穿刺により排出した液体試料を導くことが可能な流路形成体を備え、しかも前記流路形成体には、流路となる貫通孔と流路形成体外とを連通する通気路が設けられることにより、穿刺により排出された液体試料を有効に反応部に導入することが可能となるので、測定に必要な液体試料の採取量を低減できる。   The needle-integrated sensor of the present invention includes a flow path forming body capable of guiding a liquid sample discharged by puncturing at a reaction portion entrance arranged away from the tip of a puncture needle, and the flow path forming The body is provided with an air passage that connects the through-hole serving as the flow path and the outside of the flow path forming body, so that it is possible to effectively introduce the liquid sample discharged by puncture into the reaction part. The amount of collected liquid sample can be reduced.

本発明の針一体型センサの一実施形態を、図面に基づいて説明する。
図1は、本実施形態の針一体型センサの断面図である。
本実施形態の針一体型センサは、図2に示すような平板状検知部1の片面上に穿刺用針の先端が突出するように穿刺用針2を固着した針一体型センサ本体10に、図3に示すような流路形成体20が取付けられ、穿刺用針2は、流路形成体20中央の貫通孔22に挿入されている。
An embodiment of a needle integrated sensor of the present invention will be described with reference to the drawings.
FIG. 1 is a cross-sectional view of the needle integrated sensor of the present embodiment.
The needle-integrated sensor of the present embodiment has a needle-integrated sensor main body 10 in which the puncture needle 2 is fixed so that the tip of the puncture needle protrudes on one surface of a flat plate-like detection unit 1 as shown in FIG. A flow path forming body 20 as shown in FIG. 3 is attached, and the puncture needle 2 is inserted into the through hole 22 at the center of the flow path forming body 20.

平板状検知部1は、2枚の電気絶縁性基板1a、1bを、接着剤等により貼り合わせたものである。図1及び図2中、1cは接着剤部である。検知部1先端において、接着剤が塗布されていない方形状の部分があり、この方形状の接着剤非塗布部分が、血液等の液体試料を収容する反応部3を形成している。また、反応部3から絶縁性基板1aの側端縁に至るまでの細い筋状の接着剤非塗布部分があり、この接着剤非塗布部分は、反応部3と平板状検知部1外とを連通する空気孔3bを形成している。図2中、3aは、反応部3の入り口である。   The flat plate detection unit 1 is obtained by bonding two electrically insulating substrates 1a and 1b with an adhesive or the like. 1 and 2, 1c is an adhesive part. At the tip of the detection unit 1, there is a rectangular portion to which no adhesive is applied, and this rectangular non-adhesive portion forms a reaction unit 3 that accommodates a liquid sample such as blood. In addition, there is a thin streaky adhesive non-applied part from the reaction part 3 to the side edge of the insulating substrate 1a. The adhesive non-applied part connects the reaction part 3 and the outside of the flat plate detection part 1 to each other. An air hole 3b that communicates is formed. In FIG. 2, 3 a is an entrance of the reaction unit 3.

絶縁性基板1aの、接着剤が塗布された面には、一対の検知用電極パターン4が印刷等されていて、この一対の各電極4は、反応部3と交差するように、パターンが描かれている。また、血液等の液体試料と反応する試薬が、反応部3に塗布されている。従って、反応部3に収容された液体試料が試薬と反応し、化学変化で生じた電位、電流の変化を一対の電極4により検出することができる。例えば液体試料としての血液が反応部3に収容されると、試薬との反応により生じた電位変化が電極4で検知され、測定部にて血糖値などの所望の特性を測定できるようになっている。   A pair of detection electrode patterns 4 are printed on the surface of the insulating substrate 1a on which the adhesive is applied, and the pattern is drawn so that each of the pair of electrodes 4 intersects the reaction part 3. It is. A reagent that reacts with a liquid sample such as blood is applied to the reaction unit 3. Therefore, the liquid sample accommodated in the reaction unit 3 reacts with the reagent, and the potential and current changes caused by the chemical change can be detected by the pair of electrodes 4. For example, when blood as a liquid sample is accommodated in the reaction unit 3, the potential change caused by the reaction with the reagent is detected by the electrode 4, and desired characteristics such as blood glucose level can be measured by the measurement unit. Yes.

穿刺用針2は、基板1bの接着剤が塗布されていない面(「絶縁性基板の外側面」ということがある)に針用支持基板5を積設することにより固着されている。ここでいう穿刺用針としては、一般の注射器に用いるような中空の針、中実で先端が鋭利なもの、ランセット針等を用いることができる。また、平板状検知部1の2枚の基板1a、1bのうち、穿刺用針2が取りつけられていない絶縁性基板1aの外側面には、針一体型センサ本体10を測定装置に装着するための装着部6が積設されている。   The puncture needle 2 is fixed by stacking the needle support substrate 5 on the surface of the substrate 1b to which the adhesive is not applied (sometimes referred to as “the outer surface of the insulating substrate”). As the puncture needle here, a hollow needle used for a general syringe, a solid needle having a sharp tip, a lancet needle, or the like can be used. Further, of the two substrates 1a and 1b of the flat plate detection unit 1, the needle-integrated sensor body 10 is attached to the measuring device on the outer surface of the insulating substrate 1a to which the puncture needle 2 is not attached. The mounting portion 6 is stacked.

流路形成体20は、穿刺方向の加圧力により変形し、圧力解除によりほぼ元の形状に復元することができる弾性体又は粘弾性体で構成されている。具体的には、天然ゴム;合成イソプレンゴム、スチレンゴム、ニトリルゴム、クロロプレンゴム、アクリルゴム等の合成ゴム;シリコーンゴム、ウレタンゴム等のゴム状弾性体;エチレン−酢酸ビニル共重合体等の熱可塑性エラストマー;ポリスチレンフォーム等のスポンジなどを用いることができる。   The flow path forming body 20 is composed of an elastic body or a viscoelastic body that can be deformed by a pressing force in the puncture direction and can be restored to its original shape by releasing the pressure. Specifically, natural rubber; synthetic rubber such as synthetic isoprene rubber, styrene rubber, nitrile rubber, chloroprene rubber and acrylic rubber; rubber-like elastic body such as silicone rubber and urethane rubber; heat such as ethylene-vinyl acetate copolymer Plastic elastomers; sponges such as polystyrene foam can be used.

流路形成体20の針一体型センサ本体10に取付けられる側には、センサ本体10先端部を嵌挿するための嵌挿部21が凹設されている。センサ本体取付け部分である嵌挿部21のほぼ中央に、嵌挿部21の底面21aから流路形成体20の被検体当接面20aまで貫通する貫通孔22が設けられていて、この貫通孔22には、穿刺用針2の先端が収納されている。嵌挿部底面21aにおいて、反応部入り口3aの近傍となる位置から径方向に溝23aが凹設され、溝23aからやや上方の位置に、流路形成体20の周壁面を貫通する連通孔23bが穿孔されている。貫通孔22から流路形成体20外とを連通する通気路23は、溝23aと連通孔23bとの組合わせにより形成され、溝23aと連通孔23bの連結位置が屈曲部となる屈曲路となっている。   On the side of the flow path forming body 20 attached to the needle-integrated sensor main body 10, a fitting insertion portion 21 for fitting the tip of the sensor main body 10 is recessed. A through-hole 22 that penetrates from the bottom surface 21a of the insertion portion 21 to the subject contact surface 20a of the flow path forming body 20 is provided at the approximate center of the insertion portion 21 that is the sensor main body attachment portion. 22 stores the tip of the puncture needle 2. On the bottom surface 21a of the insertion portion, a groove 23a is formed in a radial direction from a position near the reaction portion entrance 3a, and a communication hole 23b penetrating the peripheral wall surface of the flow path forming body 20 at a position slightly above the groove 23a. Is perforated. The air passage 23 communicating with the outside of the flow path forming body 20 from the through hole 22 is formed by a combination of the groove 23a and the communication hole 23b, and a bending path in which the connection position of the groove 23a and the communication hole 23b is a bent portion. It has become.

以上のような構成を有する針一体型センサは、図4に示すような、表示部41、測定部42、穿刺用バネ43及びバネ操作ボタン44を具備した測定器40に装着される。装着に際しては、針一体型センサ本体10の装着部6を、測定器のセット部(図示せず)に挿入することで、穿刺用バネ43が圧縮されたセット状態となる。そして、バネ操作ボタン44を押すことによって、バネ43が圧縮状態から解除され、これに伴い、針一体型センサ本体10を穿刺方向に駆動できる。   The needle-integrated sensor having the above-described configuration is attached to a measuring instrument 40 including a display unit 41, a measuring unit 42, a puncture spring 43, and a spring operation button 44 as shown in FIG. At the time of mounting, the puncture spring 43 is compressed by inserting the mounting portion 6 of the sensor integrated sensor body 10 into a setting portion (not shown) of the measuring instrument. Then, by pushing the spring operation button 44, the spring 43 is released from the compressed state, and accordingly, the needle-integrated sensor body 10 can be driven in the puncturing direction.

穿刺用バネの圧縮状態(バネ付勢状態)で、流路形成体20の底面を被検者の皮膚M、例えば指に押し当て(図5(a)参照)、穿刺用針2を保持しているバネが伸びる方向にボタンを操作すると、針一体型センサ本体10が皮膚Mに向けて押出される。これに伴い、針一体型センサ本体10先端に取り付けられていた流路形成体20に穿刺方向の加圧力が生じ、流路形成体20が穿刺方向に圧縮ないし径方向へ膨張するように変形する。流路形成体20の変形状態で、針一体型センサ本体10先端に取り付けられた穿刺用針2が皮膚Mに向けて押出されるため、流路形成体20の被検体当接面20aから穿刺用針2が突出して、皮膚Mを穿刺する(図5(b)参照)。   In the compressed state (spring biased state) of the puncture spring, the bottom surface of the flow path forming body 20 is pressed against the subject's skin M, for example, a finger (see FIG. 5A), and the puncture needle 2 is held. When the button is operated in the direction in which the spring is extended, the needle-integrated sensor body 10 is pushed toward the skin M. Along with this, a pressure in the puncture direction is generated in the flow path forming body 20 attached to the tip of the needle-integrated sensor main body 10, and the flow path forming body 20 is deformed so as to be compressed in the puncture direction or expanded in the radial direction. . Since the puncture needle 2 attached to the distal end of the needle-integrated sensor body 10 is pushed out toward the skin M in the deformed state of the flow path forming body 20, the puncture is performed from the subject contact surface 20a of the flow path forming body 20. The needle 2 protrudes and punctures the skin M (see FIG. 5B).

次にバネによる付勢が解除されると、流路形成体20自体の復元力で、ほぼ元の形状に戻ることに伴い、穿刺用針2が皮膚Mから抜き出されて貫通孔22内に収納される(図5(c)参照)。そして、穿刺により皮膚M表面に排出された液体試料としての血液Bが、針に沿って、あるいは貫通孔22内壁面に沿って上昇する(図5(c)中、太線矢印で示す)。   Next, when the urging by the spring is released, the puncture needle 2 is pulled out from the skin M by the restoring force of the flow path forming body 20 itself, and the puncture needle 2 is pulled out into the through hole 22. It is stored (see FIG. 5C). Then, blood B as a liquid sample discharged to the surface of skin M by puncture rises along the needle or along the inner wall surface of through-hole 22 (indicated by a thick arrow in FIG. 5C).

一方、流路形成体20の復元による通気路23の開放乃至復元により、流路形成体20外から大気が流入できるだけでなく、貫通孔22内の空気を血液Bの上昇に伴って排気することもできる(図5(c)中、破線矢印で示す)。穿刺用針2に沿って上昇した血液、あるいは貫通孔22壁面をつたって上昇してきた血液は、嵌挿部底面21aにまで上昇後、空気の流れに沿って溝23aの方へ流れる。血液Bの流れは反応部入り口3aを経由することになり、当該入り口3aから反応部3内に収容される。
また、通気路23が屈曲路となっているので、空気と比べて粘度が高い液体の流動は屈曲部において阻止されることになる。従って、溝23a付近の貫通孔22壁面をつたって上昇してきた血液についても、通気路23からの流出が抑制され、反応部入り口3aの方へ流動することが期待できる。
On the other hand, not only can the atmosphere flow from the outside of the flow path forming body 20 by opening or restoring the air passage 23 by the recovery of the flow path forming body 20, but also the air in the through hole 22 is exhausted as the blood B rises. (Indicated by a broken line arrow in FIG. 5C). The blood that has risen along the puncture needle 2 or the blood that has risen along the wall surface of the through hole 22 rises to the bottom surface 21a of the insertion portion, and then flows toward the groove 23a along the air flow. The flow of blood B passes through the reaction part inlet 3a and is accommodated in the reaction part 3 from the inlet 3a.
In addition, since the ventilation path 23 is a curved path, the flow of a liquid having a higher viscosity than air is prevented at the bent portion. Therefore, it can be expected that blood that has risen through the wall surface of the through hole 22 near the groove 23a is also prevented from flowing out from the air passage 23 and flows toward the reaction portion inlet 3a.

以上のように、本実施形態の針一体型センサでは、穿刺用針2と反応部入り口3aとが離間した位置に配置されているにもかかわらず、排出された血液を有効に反応部3に導入することができるので、測定に必要な最小限の血液だけを排出させるだけでよい。従って、穿刺用針で皮膚を突き刺す部分が浅くて済み、センサ本体とは別に穿刺用針が駆動される従来のランセットタイプの測定装置よりも、被検者の痛みを軽減することが可能になる。   As described above, in the needle-integrated sensor of the present embodiment, the discharged blood is effectively transferred to the reaction unit 3 even though the puncture needle 2 and the reaction unit entrance 3a are arranged at a separated position. Since it can be introduced, only the minimum blood required for the measurement need be drained. Therefore, the portion where the skin is pierced with the puncture needle can be shallow, and the pain of the subject can be reduced as compared with the conventional lancet type measurement device in which the puncture needle is driven separately from the sensor body. .

尚、上記実施形態においては、通気路23を、嵌挿部底面21aに設けられた溝23aと流路形成体20においてセンサ本体の外嵌部となる周壁部分に穿孔された連通孔23bとにより構成したが、センサ本体取付け部分に形成される通気路は、これに限定されない。例えば、溝23aに代えて、嵌挿部底面21aの一部を切り欠いて、貫通孔22と連通孔23bとを連通させるようにしてもよいし、また、嵌挿部底面21aを空気が通過出来る程度に粗面化するだけであってもよい。また、連通孔23bに代えて、嵌挿部分のクリアランスを大きくとることによって、嵌挿部底面21aに設けられた通気路と流路形成体外とを連通するようにしてもよい。例えば、図6に示す針一体型センサに用いられる流路形成体20’では、センサ本体取付け部分となる嵌挿部21’において、嵌挿部底面21’aに空気が通ることができる程度の細い溝を設け、センサ本体10の嵌挿を遊嵌状態に設計することにより、貫通孔22と流路形成体20’外とを連通する通気路を形成している。   In the above embodiment, the air passage 23 is formed by the groove 23a provided in the bottom surface 21a of the insertion portion and the communication hole 23b drilled in the peripheral wall portion that becomes the outer fitting portion of the sensor body in the flow path forming body 20. Although comprised, the ventilation path formed in a sensor main body attachment part is not limited to this. For example, instead of the groove 23a, a part of the bottom surface 21a of the insertion portion may be cut out to allow the through hole 22 and the communication hole 23b to communicate with each other, or air may pass through the bottom surface 21a of the insertion portion. You may only roughen as much as possible. Further, instead of the communication hole 23b, the clearance of the fitting portion may be increased so that the air passage provided on the fitting portion bottom surface 21a communicates with the outside of the flow path forming body. For example, in the flow path forming body 20 ′ used in the needle-integrated sensor shown in FIG. 6, air can pass through the fitting insertion portion bottom surface 21′a in the fitting insertion portion 21 ′ serving as the sensor body attachment portion. By providing a narrow groove and designing the insertion of the sensor body 10 into a loose fit state, an air passage that connects the through hole 22 and the outside of the flow path forming body 20 ′ is formed.

また、図1に示す実施形態では、通気路23の屈曲部にあたる部分において装着部6の先端部分を切り欠くことにより、センサ本体10と流路形成体20とが実質的にクリアランスがない嵌挿により取付けられていても、溝23aと連通孔23bとの連通を確保していたが、屈曲した通気路の形成において、装着部6の切り欠きは必須ではない。一方、装着部6を嵌挿部21より上方にまで切り欠くことで、嵌挿部底面21aに形成された溝23aと装着部6の切り欠き部分とにより、流路形成体20外へ連通する通気路を形成してもよい。 Further, in the embodiment shown in FIG. 1, the sensor body 10 and the flow path forming body 20 are fitted with substantially no clearance by notching the tip portion of the mounting portion 6 at the portion corresponding to the bent portion of the air passage 23. However, the notch of the mounting portion 6 is not essential in forming a bent air passage. On the other hand, the mounting portion 6 is cut out above the insertion portion 21 so that the groove 23a formed on the bottom surface 21a of the insertion portion and the cutout portion of the mounting portion 6 communicate with the outside of the flow path forming body 20. An air passage may be formed.

さらに、図1に示す実施形態では、反応部3の上方に空気穴3bを設けていたが、本発明の針一体型センサにおいて、貫通孔22を上昇してきた液体試料が優先的に反応部入り口3aの方に導入される構成を有する限りにおいては、前記空気穴3bはなくてもよい。貫通孔22を上昇してきた液体試料が優先的に反応部入り口3aの方に導入される構成としては、通気路に屈曲部を設けて空気は流動しても液体は流動しにくい構成としてもよいし、反応部の入り口近傍に界面活性剤を塗布するだけでもよい。   Furthermore, in the embodiment shown in FIG. 1, the air hole 3 b is provided above the reaction unit 3. However, in the needle integrated sensor of the present invention, the liquid sample rising through the through-hole 22 is preferentially introduced into the reaction unit entrance. As long as it has the structure introduced into 3a, the air hole 3b may not be provided. As a configuration in which the liquid sample that has risen through the through hole 22 is preferentially introduced toward the reaction portion inlet 3a, a bent portion may be provided in the air passage so that the liquid does not flow easily even if air flows. In addition, a surfactant may be simply applied near the entrance of the reaction part.

また、上記実施形態では、センサ本体に嵌合することによって取付けられる嵌合タイプの流路形成体であったが、本発明で用いられる流路形成体はこれに限定されない。例えば、図7に示すように、流路となる貫通孔22が中央に貫設された円筒状の流路形成体25を、センサ本体10の先端に接着剤等で固着することによって取付けてもよい。流路形成体25において、通気路は、センサ本体取付け面25aに径方向に延設された溝26である。   Moreover, in the said embodiment, although it was the fitting type flow path formation body attached by fitting to a sensor main body, the flow path formation body used by this invention is not limited to this. For example, as shown in FIG. 7, a cylindrical flow path forming body 25 having a through-hole 22 serving as a flow path provided in the center may be attached to the tip of the sensor body 10 by being fixed with an adhesive or the like. Good. In the flow path forming body 25, the air passage is a groove 26 extending in the radial direction on the sensor body mounting surface 25a.

さらに、上記実施形態では、反応部入り口が貫通孔に直接連通していたが、通気路の途中に反応部入り口を配置することで、流路となる貫通孔に連通していてもよい。この場合、通気路を流れる液体試料が、さらに通気路内を流動して流路形成体外へ流出してしまうよりも、優先的に反応部入り口から反応部内へ流入されるように、反応部入り口から流路形成体外までの通気路部分において、屈曲部等の液体流出防止機構を設けたり、通気路を流動するよりも反応部内へ液体試料が優先的に流入しやすいように、反応部の入り口近傍に界面活性剤を塗布してもよい。   Furthermore, in the said embodiment, although the reaction part inlet_port | entrance communicated directly with the through-hole, you may communicate with the through-hole used as a flow path by arrange | positioning the reaction part inlet_port | entrance in the middle of a ventilation path. In this case, the liquid sample flowing through the ventilation path is more preferentially flowed from the reaction section inlet into the reaction section than flowing out of the flow path formation body after flowing in the ventilation path. At the entrance of the reaction part, a liquid outflow prevention mechanism such as a bent part is provided in the air passage part extending from the flow path to the outside of the flow path forming body, or the liquid sample is preferentially flowed into the reaction part rather than flowing through the air passage. A surfactant may be applied in the vicinity.

本発明の針一体型センサにおいて、通気路の設けられる位置は、センサ本体取付け部分に限定されない。流路となる貫通孔と流路形成体外とを連通するように設けられていればよく、例えば、貫通孔の途中となる位置で、流路形成体の周壁を穿孔した連通孔であってもよい。   In the needle-integrated sensor of the present invention, the position where the air passage is provided is not limited to the sensor body mounting portion. It is only necessary that the through hole serving as the flow path communicates with the outside of the flow path forming body. For example, even though the communication hole is formed by drilling the peripheral wall of the flow path forming body at a position in the middle of the through hole. Good.

また、通気路は、流路形成体の被検体当接面に形成されてもよく、被検体に当接した状態で貫通孔と流路形成体外とが連通するように設けられていればよい。被検体の当接面に通気路が設けられる場合、被検体表面に排出された液体試料が当該通気路から流路形成体外へ漏れ出ることを防止する液体流出防止機構を備えていることが好ましい。上記実施形態では、通気路の途中に屈曲部を設けることによって、液体が流路形成体外へ流出することを防止していたが、液体流出を防止する防護壁を、貫通孔を形成する周壁とは別に設けてもよい。このような構成を有する流路形成体としては、例えば、図8及び図9に示すような二重壁構造を有する流路形成体30が挙げられる。   In addition, the air passage may be formed on the subject contact surface of the flow path forming body, and may be provided so that the through hole communicates with the outside of the flow path forming body in contact with the subject. . When a ventilation path is provided on the contact surface of the subject, it is preferable to include a liquid outflow prevention mechanism that prevents the liquid sample discharged on the subject surface from leaking out of the flow path formation body from the ventilation path. . In the above embodiment, by providing a bent portion in the middle of the air passage, the liquid is prevented from flowing out of the flow path forming body, but the protective wall for preventing the liquid outflow is a peripheral wall that forms a through hole. May be provided separately. Examples of the flow path forming body having such a configuration include a flow path forming body 30 having a double wall structure as shown in FIGS. 8 and 9.

流路形成体30は、流路となる貫通孔22を構成する内壁30a、及び液体流出の防護壁で且つ流路形成体30の周壁となる外壁30bの二重壁構造を有している。内壁30aの被検体当接側の面は、外壁30bの被検体当接側の面よりもやや低くなっていて、これにより、流路形成体30を単に被検体(図9中、一点鎖線で示す)に当接させた状態では、外壁30bの被検体当接側の面が被検体当接面となり、内壁30aと被検体との間に隙間Sが生じるようになっている。外壁30bの被検体当接面に切り欠き部31が切り欠きされ、流路形成体30を被検体に当接した状態において、切り欠き部31、さらには内壁30aと被検体当接面との間に形成される隙間Sを介して、貫通孔22と流路形成体30外とが連通するようになっている。つまり、切り欠き部31、内壁30aと外壁30bとの間の谷部30c、及び内壁30aと被検体当接面との間に形成される隙間Sにより通気路が構成される。このような流路形成体30を備えた針一体型センサでは、穿刺方向の加圧により、流路形成体30が圧縮され、貫通孔22から穿刺用針先端が突出して皮膚を突き刺す。かかる状態では、内壁30aの被検体側の面が、被検体に当接し、貫通孔22は略密閉状態となっている。加圧力の解除により、流路形成体30が復元し、内壁30aと被検体との間に隙間Sができ、貫通孔22と通気路が連通した状態となる。かかる状態では、通気路を介して、流路形成体30外と貫通孔22との間で、空気の流出入がおこることができる。被検体当接面からの空気の流入は、流路形成体22内を大気圧に戻すことで、穿刺用針が被検体から引き抜かれたときの血液の排出を促すことが期待できる。皮膚表面に排出された血液は、穿刺用針2及び貫通孔22の周壁である内壁30aの内周面を通って反応部入り口3aに導かれることができる。このときも、通気路による空気の流出入、特に被検体当接面からの空気の流入により、貫通孔22内を血液が上昇していくことを促進することを期待できる。一方、外壁30bにより、皮膚表面に排出された血液が流路形成体30外へ流出することを防止している。尚、被検体当接面側に通気路が設けられた場合において、液体流出防止機構を備えるだけでなく、貫通孔22の入り口となる、内壁30aの被検体側の開口部付近に界面活性剤を塗布して、液体試料が谷部30cよりも貫通孔22へ優先的に流入するようにしてもよい。   The flow path forming body 30 has a double wall structure of an inner wall 30 a constituting the through hole 22 that becomes a flow path and an outer wall 30 b that is a protective wall for liquid outflow and a peripheral wall of the flow path forming body 30. The surface of the inner wall 30a on the subject contact side is slightly lower than the surface of the outer wall 30b on the subject contact side, so that the flow path forming body 30 is simply placed on the subject (indicated by a one-dot chain line in FIG. 9). In this state, the surface on the subject contact side of the outer wall 30b becomes the subject contact surface, and a gap S is formed between the inner wall 30a and the subject. In a state where the notch 31 is notched in the subject contact surface of the outer wall 30b and the flow path forming body 30 is in contact with the subject, the notch 31 and the inner wall 30a and the subject contact surface are in contact with each other. The through-hole 22 communicates with the outside of the flow path forming body 30 through a gap S formed therebetween. That is, the air passage is constituted by the notch 31, the valley 30c between the inner wall 30a and the outer wall 30b, and the gap S formed between the inner wall 30a and the subject contact surface. In the needle integrated sensor provided with such a flow path forming body 30, the flow path forming body 30 is compressed by pressurization in the puncturing direction, and the tip of the puncture needle protrudes from the through hole 22 to pierce the skin. In such a state, the subject-side surface of the inner wall 30a is in contact with the subject, and the through hole 22 is in a substantially sealed state. By releasing the applied pressure, the flow path forming body 30 is restored, a gap S is formed between the inner wall 30a and the subject, and the through hole 22 and the air passage are in communication with each other. In such a state, air can flow in and out between the outside of the flow path forming body 30 and the through hole 22 through the ventilation path. The inflow of air from the subject contact surface can be expected to promote blood discharge when the puncture needle is pulled out from the subject by returning the flow path forming body 22 to atmospheric pressure. The blood discharged to the skin surface can be guided to the reaction portion inlet 3a through the inner peripheral surface of the inner wall 30a that is the peripheral wall of the puncture needle 2 and the through hole 22. At this time as well, it can be expected that blood will rise in the through hole 22 due to the inflow and outflow of air through the air passage, particularly the inflow of air from the subject contact surface. On the other hand, the blood discharged to the skin surface is prevented from flowing out of the flow path forming body 30 by the outer wall 30b. In the case where a vent path is provided on the subject contact surface side, not only a liquid outflow prevention mechanism is provided, but also a surfactant in the vicinity of the subject-side opening of the inner wall 30a that serves as the entrance to the through hole 22. May be applied so that the liquid sample preferentially flows into the through hole 22 rather than the trough 30c.

尚、本発明の針一体型センサにおいて、流路形成体に設けられる通気路は1つに限定されず、穿刺により排出させた液体試料を有効に反応部に収容できる構成であれば、異なる複数の通気路を設けてもよい。例えば、流路形成体30において、被検体当接面側に設けた通気路とは別に、図1の実施形態で示したように、センサ本体取付け部分にも通気路を設けてもよい。   In the needle-integrated sensor of the present invention, the number of air passages provided in the flow path forming body is not limited to one, and a plurality of different air paths can be used as long as the liquid sample discharged by puncture can be effectively stored in the reaction unit. An air passage may be provided. For example, in the flow path forming body 30, apart from the air flow path provided on the subject contact surface side, as shown in the embodiment of FIG.

また、上記実施形態では、いずれも流路形成体を弾性体又は粘弾性体で構成し、流路形成体の変形、復元を利用して、針の突き刺し及び引抜きを行なったが、本発明の針一体型センサがこれに限定しない。流路形成体を剛体で構成してもよい。この場合、穿刺用針が流路形成体から出没できるように、針一体型センサが装着される測定器に、針一体型センサ本体を穿刺方向に駆動する駆動機構とともに、針を引き戻す駆動機構を具備すればよい。   In the above embodiment, the flow path forming body is composed of an elastic body or a viscoelastic body, and the needle is pierced and pulled out by utilizing the deformation and restoration of the flow path forming body. The needle integrated sensor is not limited to this. You may comprise a flow-path formation body with a rigid body. In this case, in order to allow the puncture needle to appear and disappear from the flow path forming body, the measuring instrument to which the needle integrated sensor is attached has a drive mechanism for driving the needle integrated sensor body in the puncture direction and a drive mechanism for pulling back the needle. It may be provided.

また、上記実施形態では、いずれも穿刺用針が反応部の外側に取付けられていたが、本発明の針一体型センサにおいて、例えば、図10に示すように、穿刺用針を反応部3’内に取付け固定してもいてもよい。尚、図10に示す針一体型センサに用いた流路形成体20”では、通気路23’は、貫通孔22の途中に設けられている。   In the above embodiments, the puncture needle is attached to the outside of the reaction part. However, in the needle integrated sensor of the present invention, for example, as shown in FIG. 10, the puncture needle is attached to the reaction part 3 ′. It may be mounted and fixed inside. In the flow path forming body 20 ″ used in the needle integrated sensor shown in FIG. 10, the air passage 23 ′ is provided in the middle of the through hole 22.

さらにまた、図1に示す実施形態では、針が取り付けられていない方の絶縁性基板に電極が設けられていたが、本発明の針一体型センサは、針取付位置と電極基板の位置関係は限定しない。針取付側の基板に電極が設けられていても良いし、正極、負極が同じ基板に設けられている必要もない。一方の基板に正極、他方の基板に負極が設けられていてもよい。また、検知部は、2枚の基板を貼り合せる構成であったが、例えば、国際公開2005−010519に開示のように、1枚の基板上に一対の電極を配置し、電極が内側となるように折り曲げることにより構成してもよい。また、検知部の形状も平板状だけでなく、円筒形であってもよく、反応部も円筒状であってもよい。   Furthermore, in the embodiment shown in FIG. 1, the electrode is provided on the insulating substrate to which the needle is not attached. However, in the needle integrated sensor of the present invention, the positional relationship between the needle attachment position and the electrode substrate is Not limited. Electrodes may be provided on the substrate on the needle mounting side, and it is not necessary that the positive electrode and the negative electrode are provided on the same substrate. One substrate may be provided with a positive electrode and the other substrate may be provided with a negative electrode. In addition, the detection unit has a configuration in which two substrates are bonded together. For example, as disclosed in International Publication No. 2005-010519, a pair of electrodes is arranged on one substrate, and the electrodes are on the inside. You may comprise by bending in this way. Moreover, the shape of the detection unit is not limited to a flat plate shape, and may be a cylindrical shape, and the reaction unit may be a cylindrical shape.

本発明一実施形態の針一体型センサの構成を示す断面図である。It is sectional drawing which shows the structure of the needle | hook integrated sensor of one Embodiment of this invention. 図1に示す針一体型センサに用いられている検知部の一例を示す平面図(a)及び断面図(b)である。It is the top view (a) and sectional drawing (b) which show an example of the detection part used for the needle | hook integrated sensor shown in FIG. 本発明一実施形態の針一体型センサに用いられている流路形成体の構成を示す斜視図である。It is a perspective view which shows the structure of the flow-path formation body used for the needle | hook integrated sensor of one Embodiment of this invention. 本実施形態の針一体型センサを装着した測定装置の一実施例の構成を示す概略図である。It is the schematic which shows the structure of one Example of the measuring apparatus with which the needle | hook integrated sensor of this embodiment was mounted | worn. 本実施形態の針一体型センサの使用方法を説明するための図である。It is a figure for demonstrating the usage method of the needle | hook integrated sensor of this embodiment. 本発明の針一体型センサの他の実施形態を示す断面図である。It is sectional drawing which shows other embodiment of the needle | hook integrated sensor of this invention. 本発明の針一体型センサの他の実施形態を示す断面図である。It is sectional drawing which shows other embodiment of the needle | hook integrated sensor of this invention. 本発明の針一体型センサに用いられる流路形成体の他の実施形態を示す図である。It is a figure which shows other embodiment of the flow-path formation body used for the needle | hook integrated sensor of this invention. 図8に示す流路形成体を取付けた針一体型センサの構成を示す断面図である。It is sectional drawing which shows the structure of the needle | hook integrated sensor which attached the flow-path formation body shown in FIG. 発明の針一体型センサの他の実施形態を示す断面図である。It is sectional drawing which shows other embodiment of the needle | hook integrated sensor of invention. 従来のランセット一体型センサの構成を示す図である。It is a figure which shows the structure of the conventional lancet integrated sensor.

符号の説明Explanation of symbols

1 検知部
2 穿刺用針
3,3’ 反応部
3a 反応部入り口
10 センサ本体
20,20’,20”,25,30 流路形成体
21,21’ 嵌挿部
22 貫通孔
23,23’,26 通気路
DESCRIPTION OF SYMBOLS 1 Detection part 2 Puncture needle 3,3 'Reaction part 3a Reaction part entrance 10 Sensor main body 20,20', 20 ", 25,30 Flow path formation body 21,21 'Insertion part 22 Through-hole 23,23', 26 Airway

Claims (7)

被検体から液体試料を排出させる穿刺用針、前記液体試料が収容される反応部、及び該反応部の結果を検知する検知部を一体的に備えるとともに、前記穿刺用針、前記反応部、及び前記検知部が一体的に可動するように設けられている針一体型センサ本体と、
前記被検体の当接部分から前記反応部への流路となる貫通孔が設けられ、該貫通孔に前記穿刺用針が内挿されている流路形成体とを備えた針一体型センサであって、
前記貫通孔と前記流路形成体外とを連通する通気路が、前記流路形成体に設けられている針一体型センサ。
Puncturing needle for discharging the liquid sample from the subject, wherein the reaction unit in which the liquid sample is accommodated, and Rutotomoni includes a detector for detecting the result of the reaction portion integrally, the puncture needle, the reaction section, And a needle-integrated sensor main body provided so that the detection unit is integrally movable ,
A needle integrated sensor provided with a flow path forming body in which a through hole serving as a flow path from the contact portion of the subject to the reaction section is provided, and the puncture needle is inserted into the through hole; There,
A needle-integrated sensor in which an air passage that communicates the through hole and the outside of the flow path forming body is provided in the flow path forming body.
前記流路形成体は、変形により、前記貫通孔の穿刺方向長さを変えて前記貫通孔から前記穿刺用針を出没可能にする弾性体又は粘弾性体で構成されている請求項1に記載の針一体型センサ。 The said flow path formation body is comprised with the elastic body or viscoelastic body which changes the puncture direction length of the said through-hole by deformation | transformation, and enables the said puncture needle to protrude and retract from the said through-hole. Needle integrated sensor. 前記通気路は、前記針一体型センサ本体の取付け部分に設けられている請求項1又は2に記載の針一体型センサ。 The needle integrated sensor according to claim 1 or 2, wherein the air passage is provided in a mounting portion of the needle integrated sensor main body. 前記反応部入り口が前記通気路の途中又は前記通気路入り口の近傍に位置するように、前記通気路が設けられている請求項3に記載の針一体型センサ。 The needle integrated sensor according to claim 3, wherein the air passage is provided so that the reaction portion entrance is located in the middle of the air passage or in the vicinity of the air passage entrance. 前記通気路に、液体流出防止機構を設けた請求項1〜4のいずれかに記載の針一体型センサ。 The needle integrated sensor according to any one of claims 1 to 4, wherein a liquid outflow prevention mechanism is provided in the air passage. 前記液体流出防止機構は、前記通気路の途中に設けられた屈曲部である請求項5に記載の針一体型センサ。 The needle integrated sensor according to claim 5, wherein the liquid outflow prevention mechanism is a bent portion provided in the middle of the air passage. 少なくとも前記反応部の入り口近傍に、界面活性剤が塗布されている請求項1〜6のいずれかに記載の針一体型センサ。 The needle integrated sensor according to any one of claims 1 to 6, wherein a surfactant is applied at least in the vicinity of the entrance of the reaction part.
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EP07850734A EP2098167A1 (en) 2006-12-19 2007-12-17 Biosensor cartridge, method of using biosensor cartridge, biosensor device and needle-integrated sensor
PCT/JP2007/074246 WO2008075651A1 (en) 2006-12-19 2007-12-17 Biosensor cartridge, method of using biosensor cartridge, biosensor device and needle-integrated sensor

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