JP6120257B2 - Needle-like device for skin puncture, device for collecting biological components, and biological component measuring system - Google Patents

Needle-like device for skin puncture, device for collecting biological components, and biological component measuring system Download PDF

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JP6120257B2
JP6120257B2 JP2011205813A JP2011205813A JP6120257B2 JP 6120257 B2 JP6120257 B2 JP 6120257B2 JP 2011205813 A JP2011205813 A JP 2011205813A JP 2011205813 A JP2011205813 A JP 2011205813A JP 6120257 B2 JP6120257 B2 JP 6120257B2
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needle
biological component
skin
conduction hole
dialysate
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芳賀 洋一
洋一 芳賀
忠雄 松永
忠雄 松永
良一 永富
良一 永富
石井 賢治
賢治 石井
典子 鶴岡
典子 鶴岡
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Tohoku University NUC
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本発明は、生体成分を測定するために使用される皮膚穿刺用針状デバイス、生体成分回収用デバイスおよび生体成分測定システムに関する。
The present invention relates to a skin puncture needle-like device, a biological component recovery device, and a biological component measurement system that are used for measuring biological components.

生体成分は、体の健康状態を知る上で重要な指標であり、一般に、血液や尿、唾液などを用いて、様々な健康状態についての検査が行われている。従来の乳酸やグルコースなどの生体成分を測定する装置として、少量の血液を採取して計測を行うものがある(例えば、特許文献1または2参照)。   The biological component is an important index for knowing the health condition of the body, and in general, various health tests are performed using blood, urine, saliva, and the like. As a conventional apparatus for measuring biological components such as lactic acid and glucose, there is one that collects a small amount of blood and performs measurement (see, for example, Patent Document 1 or 2).

また、従来、脳内や腹部皮下脂肪内の生体成分を回収する方法として、マイクロダイアリシス法が利用されている。この方法は、微細な流路と透析膜とを搭載したプローブを組織に挿入し、浸透圧を利用して必要な生体成分を連続的に回収するものである(例えば、特許文献3参照)。プローブとしては、平型針または中空針などの形が開発されている(例えば、非特許文献1または2参照)。   Conventionally, a microdialysis method has been used as a method of collecting biological components in the brain and abdominal subcutaneous fat. In this method, a probe equipped with a fine flow path and a dialysis membrane is inserted into a tissue, and necessary biological components are continuously collected using osmotic pressure (for example, see Patent Document 3). As a probe, a shape such as a flat needle or a hollow needle has been developed (see, for example, Non-Patent Document 1 or 2).

なお、皮下約0.2〜2mmの真皮および皮下2〜4mmの皮下組織に満たされている皮下組織液と血液との間で、血管壁を通して生体成分の交換が行われている。このため、乳酸やグルコースなどの低分子量の生体成分の血液中の濃度は、皮下組織液中の濃度とほぼ平衡状態にあり、それらの間には相関があることが報告されている(例えば、非特許文献3参照)。   It should be noted that biological components are exchanged through the blood vessel wall between the blood and the subcutaneous tissue fluid filled in the subcutaneous skin of about 0.2 to 2 mm and the subcutaneous tissue of 2 to 4 mm. For this reason, it has been reported that the concentrations of low-molecular weight biological components such as lactic acid and glucose in the blood are almost in equilibrium with the concentrations in the subcutaneous tissue fluid (for example, there is a non-correlation). (See Patent Document 3).

特許第3978489号公報Japanese Patent No. 3978489 特許第3498105号公報Japanese Patent No. 3498105 特表2006−501912号公報JP-T-2006-501912

Jeffrey D. Zahn, et al, “MicrodialysisMicroneedles for Continuous Medical Monitoring”, Biomedical Microdevices, 2005,Vol.7, No.1, p59-69Jeffrey D. Zahn, et al, “Microdialysis Microneedles for Continuous Medical Monitoring”, Biomedical Microdevices, 2005, Vol. 7, No. 1, p59-69 M. Ellmerer, et al, “Continuous measurement ofsubcutaneous lactate concentration during exercise by combining open-flowmicroperfusion and thin-film lactate sensors”, Biosensors & Bioelectronics,1998, Vol.13, p1007-1013M. Ellmerer, et al, “Continuous measurement of subcutaneous lactate concentration during exercise by combining open-flowmicroperfusion and thin-film lactate sensors”, Biosensors & Bioelectronics, 1998, Vol.13, p1007-1013 伊藤成史, “マイクロバイオセンサを用いた経皮的乳酸濃度計測”, M&BE, 1995, Vol.6, No.4, p275-283Narumi Ito, “Measurement of transdermal lactic acid concentration using microbiosensor”, M & BE, 1995, Vol.6, No.4, p275-283

特許文献1および2に記載の血液を採取して生体成分の測定を行うものは、穿刺の際に多少の痛みを伴うという課題があった。また、測定のたびに穿刺して採血する必要があるため、継続して生体成分を測定するのが困難であるという課題もあった。非特許文献1または2に記載のような、マイクロダイアリシス法で従来使用されていたプローブは、設置の際に、手術をしたり、専用の刺入器具を使用したりしなければならず、手間がかかるという課題があった。   The thing which collect | recovers the blood of patent document 1 and 2 and measures a biological component had the subject that it accompanied some pain in the case of puncture. Moreover, since it is necessary to puncture and collect blood for each measurement, there is also a problem that it is difficult to continuously measure biological components. The probe conventionally used in the microdialysis method as described in Non-Patent Document 1 or 2 must be operated at the time of installation, or a dedicated insertion device must be used. There was a problem of taking time and effort.

本発明は、このような課題に着目してなされたもので、刺すだけで容易に設置可能で、穿刺の際の痛みが小さく、継続して生体成分を測定することができる皮膚穿刺用針状デバイス、生体成分回収用デバイスおよび生体成分測定システムを提供することを目的としている。
The present invention has been made in view of such problems, stinging in easily installed only small pain during puncture, continuous needle for skin-piercing capable of measuring biological components It is an object to provide a device, a biological component recovery device, and a biological component measurement system.

本発明に係る皮膚穿刺用針状デバイスは、断面が円形である円形断面を有する針から成る針体と、前記針体の長さ方向に沿って、前記針体の少なくとも前記円形断面部分の側面に設けられた表層膜と、前記針体の長手方向に伸びるよう前記表層膜に設けられた導通孔とを有し、前記導通孔は、前記針体を皮膚に刺したとき、皮下組織まで達し、前記皮下組織液中の生体成分を回収または測定することができるよう設けられていることを特徴とする。
A needle-like device for skin puncture according to the present invention includes a needle body composed of a needle having a circular cross section having a circular cross section, and a side surface of at least the circular cross section of the needle body along the length direction of the needle body. And a conduction hole provided in the surface layer so as to extend in the longitudinal direction of the needle body, and the conduction hole reaches the subcutaneous tissue when the needle body is pierced into the skin. The biological component in the subcutaneous tissue fluid is provided so as to be collected or measured.

本発明に係る皮膚穿刺用針状デバイスは、その先端から皮膚に刺すことにより、厚さ約0.2mmの表皮を突き抜けて、真皮や皮下組織まで達することができる。このとき、針体の長手方向に伸びるよう設けられた導通孔を利用することにより、皮下組織液中の生体成分を回収したり、測定したりすることができる。乳酸やグルコースなどの低分子量の生体成分は、血液中の濃度と皮下組織液中の濃度とがほぼ平衡状態にあり、それらの間には相関があるため、皮下組織液中の生体成分を測定することにより、血液中の生体成分を測定するのと同様の結果が得られる。このように、本発明に係る皮膚穿刺用針状デバイスは、刺すだけで容易に設置可能であり、どこにでも刺して生体成分を測定することができる。
The needle-like device for skin puncture according to the present invention can reach the dermis and subcutaneous tissue through the epidermis having a thickness of about 0.2 mm by piercing the skin from its tip. At this time, the biological component in the subcutaneous tissue fluid can be collected or measured by using a conduction hole provided so as to extend in the longitudinal direction of the needle body. For biological components of low molecular weight such as lactic acid and glucose, the concentration in blood and the concentration in subcutaneous tissue fluid are almost in equilibrium, and there is a correlation between them, so measure biological components in subcutaneous tissue fluid Thus, the same result as that obtained by measuring a biological component in blood can be obtained. In this way, the needle-like device for skin puncture according to the present invention can be easily installed simply by pricking, and can stab anywhere and measure biological components.

また、針体に、太さが0.2mm程度の鍼灸用の針などの、径が小さい針を利用することにより、穿刺の際の痛みを小さくすることができる。また、径が小さい針を利用することにより、刺したまま日常の諸活動や行動を行っても、皮膚穿刺用針状デバイスが破損したり、出血したりせず、装着感、違和感も極めて小さい。このため、日常の諸活動や行動中でも継続して生体成分を測定することができる。
Moreover, the pain at the time of puncture can be reduced by using a needle | hook with small diameters, such as an acupuncture needle about 0.2 mm in thickness, for a needle body. In addition, by using a needle with a small diameter , the needle-like device for skin puncture does not break or bleed even if daily activities and actions are performed while being stabbed, and the wearing feeling and discomfort are extremely small . For this reason, it is possible to continuously measure biological components during daily activities and actions.

導通孔が表層膜に覆われて設けられており、針体を直接加工する必要がないため、製造が容易で、導通孔を所望の構造に加工しやすい。表層膜は、導通孔を任意に加工できるよう、レーザーアブレーション等により微小加工が可能なポリイミドなどの素材から成ることが好ましい。
本発明に係る皮膚穿刺用針状デバイスは、以下に示すように、生体成分を測定するために、様々な方法で使用することができる。
Since the conduction hole is provided so as to be covered with the surface layer film, it is not necessary to directly process the needle body, so that the manufacturing is easy and the conduction hole is easily processed into a desired structure. The surface layer film is preferably made of a material such as polyimide that can be micro-processed by laser ablation or the like so that the conduction hole can be arbitrarily processed.
The needle-like device for skin puncture according to the present invention can be used in various ways to measure biological components as will be described below.

本発明に係る生体成分回収用デバイスは、透析を利用して生体成分を回収するための生体成分回収用デバイスであって、本発明に係る皮膚穿刺用針状デバイスを有し、前記導通孔は、前記針体を皮膚に刺したとき、表皮より外側の位置に流入口と排出口とを有し、前記流入口から、前記針体を皮膚に刺したとき、皮下組織まで達する位置まで伸びて前記排出口に循環して戻るよう設けられ、前記表層膜は、前記針体を皮膚に刺したとき、真皮または皮下組織まで達する位置に、前記生体成分を通過可能に前記導通孔に連通するよう設けられた1または複数の透析穴を有することを特徴とする。
The biological component recovery device according to the present invention is a biological component recovery device for recovering a biological component using dialysis, and has the skin puncture needle device according to the present invention, wherein the conduction hole is When the needle body is stabbed into the skin, it has an inlet and an outlet at a position outside the epidermis, and extends from the inlet to a position reaching the subcutaneous tissue when the needle body is stabbed into the skin. It is provided so as to circulate back to the discharge port, and the surface layer film communicates with the conduction hole so as to allow the biological component to pass to a position reaching the dermis or subcutaneous tissue when the needle body is inserted into the skin. It has one or a plurality of dialysis holes provided.

本発明に係る生体成分回収用デバイスは、透析穴が真皮や皮下組織に位置するよう、先端部を皮膚に刺して使用される。皮膚に刺した状態で、流入口から、針体を皮膚に刺したとき、皮下組織まで達する位置まで伸びて排出口に循環して戻るよう設けられた導通孔に、透析液を循環させる。これにより、浸透圧を利用して、皮下組織液中の生体成分を、透析穴を通して導通孔内の透析液中に回収することができる。
The biological component collection device according to the present invention is used by piercing the skin with the tip so that the dialysis hole is located in the dermis or subcutaneous tissue. When the needle body is stabbed into the skin from the inlet with the skin stabbed , the dialysate is circulated through a conduction hole provided so as to extend to a position reaching the subcutaneous tissue and circulate back to the outlet. Thereby, the biological component in a subcutaneous tissue fluid can be collect | recovered in the dialysate in a conduction hole through a dialysis hole using an osmotic pressure.

本発明に係る生体成分回収用デバイスは、皮膚に刺す深さを抑えるために、透析穴ができるだけ針体の先端に近い位置に設けられていることが好ましい。透析穴は、分子量の大きいタンパク質等が導通孔に入り込まないよう、測定対象の生体成分の大きさに応じた大きさに形成されていることが好ましい。本発明に係る生体成分回収用デバイスは、導通孔の針体の先端側に、表層膜を貫通して設けられた貫通口を有し、その貫通口を覆うよう設けられた半透膜を有していてもよい。この場合、半透膜に形成されている穴が、透析穴を成している。   In the biological component collecting device according to the present invention, it is preferable that the dialysis hole is provided as close to the tip of the needle body as possible in order to suppress the depth of penetration into the skin. The dialysis hole is preferably formed in a size corresponding to the size of the biological component to be measured so that proteins having a large molecular weight do not enter the conduction hole. The biological component collection device according to the present invention has a through-hole provided through the surface layer film on the distal end side of the needle body of the conduction hole, and a semipermeable membrane provided so as to cover the through-hole. You may do it. In this case, the hole formed in the semipermeable membrane forms a dialysis hole.

本発明に係る生体成分測定システムは、本発明に係る生体成分回収用デバイスと、透析液を貯蔵し、前記流入口に接続された透析液タンクと、前記透析液タンクの前記透析液を前記流入口から前記導通孔に流すための送液ポンプと、前記導通孔を通って前記排出口から排出された前記透析液に含まれる前記生体成分を測定可能に設けられた測定手段と、前記測定手段で測定された後の前記透析液を貯蔵する排液タンクとを、有することを特徴とする。   The biological component measurement system according to the present invention stores the biological component recovery device according to the present invention, a dialysate stored in the dialysate, and the dialysate tank connected to the inflow port, and the dialysate in the dialysate tank. A liquid feed pump for flowing from the inlet to the conduction hole, a measurement means provided so as to be able to measure the biological component contained in the dialysate discharged from the discharge port through the conduction hole, and the measurement means And a drainage tank for storing the dialysate after measurement in (1).

本発明に係る生体成分測定システムは、透析液タンクに貯蔵された透析液を、送液ポンプにより流入口から導通孔に流すことにより、導通孔に透析液を循環させることができる。この循環により生体成分が透析液中に回収されるため、排出口から排出された透析液に含まれる生体成分を測定手段で測定することにより、皮下組織液中に含まれると考えられる生体成分を測定することができる。また、送液ポンプで透析液を連続して送り続けることにより、測定手段で生体成分を継続的または間欠的に測定することができ、生体成分の経時的な変化を測定することができる。測定後の透析液は、排液タンクに貯蔵して回収し、廃棄することができる。   The biological component measurement system according to the present invention can circulate dialysate through the conduction hole by flowing the dialysate stored in the dialysate tank from the inflow port to the conduction hole by the liquid feed pump. Since the biological components are collected in the dialysate by this circulation, the biological components that are considered to be contained in the subcutaneous tissue fluid are measured by measuring the biological components contained in the dialysate discharged from the discharge port with the measuring means. can do. Further, by continuously feeding the dialysate with the liquid feed pump, the biological component can be measured continuously or intermittently by the measuring means, and the change of the biological component over time can be measured. The dialysate after the measurement can be stored and recovered in a drainage tank and discarded.

透析液は、皮下組織液との間で透析を行うことができ、回収した生体成分を分析可能であれば、いかなる成分から成っていてもよい。透析液は、例えば生理食塩水から成っている。測定手段は、測定対象の生体成分を測定可能であればよく、例えば、乳酸やグルコースを測定する場合には、それぞれを測定可能な酵素センサから成っていてもよい。測定手段は、後で測定結果を回収して解析を行えるよう、測定結果を記憶する記憶部を有していてもよい。本発明に係る生体成分測定システムは、測定手段を交換することにより、様々な種類の生体成分を測定することができる。また、測定手段を複数設けることにより、一度に複数種類の生体成分を測定することができる。測定手段で測定した結果を表示する表示手段を有していてもよい。   The dialysate may be composed of any component as long as it can be dialyzed against the subcutaneous tissue fluid and the collected biological component can be analyzed. The dialysate is made of, for example, physiological saline. The measuring means only needs to be able to measure a biological component to be measured. For example, when measuring lactic acid or glucose, the measuring means may be composed of an enzyme sensor capable of measuring each. The measuring means may have a storage unit for storing the measurement results so that the measurement results can be collected and analyzed later. The biological component measuring system according to the present invention can measure various types of biological components by exchanging the measuring means. Also, by providing a plurality of measuring means, it is possible to measure a plurality of types of biological components at a time. You may have a display means to display the result measured by the measurement means.

本発明に係る生体成分測定システムおよび生体成分回収用デバイスで、生体成分は、例えば乳酸、グルコース、アルコール、水分、ナトリウムイオンやカリウムイオンなどのイオン、ホルモン成分など、透析により回収可能な生体成分であれば、いかなるものであってもよい。例えば、測定対象の生体成分が乳酸から成る場合には、乳酸濃度との相関が強い運動強度を測定することができる。   In the biological component measurement system and the biological component recovery device according to the present invention, the biological component is a biological component that can be recovered by dialysis, such as lactic acid, glucose, alcohol, moisture, ions such as sodium ions and potassium ions, and hormone components. Anything is acceptable. For example, when the biological component to be measured is made of lactic acid, it is possible to measure exercise intensity that has a strong correlation with the lactic acid concentration.

本発明に係る皮膚穿刺用針状デバイスで、前記導通孔は1対から成り、それぞれ光を通過可能に構成され、前記針体を皮膚に刺したとき、真皮または皮下組織まで達する位置に開口を有していてもよい。また、この場合、本発明に係る生体成分測定システムは、本発明に係る皮膚穿刺用針状デバイスと、前記針体を皮膚に刺したとき、表皮より外側の位置から一方の導通孔に光を通す発光手段と、前記針体を皮膚に刺したとき、表皮より外側の位置で他方の導通孔を通る光を測定する光測定手段とを、有していてもよい。これらの場合、発光手段から発して真皮や皮下組織を通った光を、光測定手段で測定することができる。この測定結果を利用して、真皮や皮下組織中の生体成分の分析を行うことができる。
In the needle puncture device for skin puncture according to the present invention, the conduction holes are composed of a pair, each configured to allow light to pass through , and when the needle body is pierced into the skin, an opening is formed at a position reaching the dermis or subcutaneous tissue. You may have. Further, in this case, the biological component measurement system according to the present invention provides a needle-like device for skin puncture according to the present invention and light from one position outside the epidermis to one conduction hole when the needle body is stabbed into the skin. You may have the light emission means to let pass, and the light measurement means to measure the light which passes the other conduction hole in the position outside the epidermis when the needle body is stabbed in the skin . In these cases, light emitted from the light emitting means and passing through the dermis or subcutaneous tissue can be measured by the light measuring means. By utilizing this measurement result, it is possible to analyze biological components in the dermis and subcutaneous tissue.

本発明に係る生体成分測定システムは、一方の面に粘着剤層を有する貼付シートを有し、前記皮膚穿刺用針状デバイスは、先端部が前記粘着剤層から突出するよう前記貼付シートに取り付けられ、前記皮膚穿刺用針状デバイス以外の部品は、前記貼付シートの他方の面側に取り付けられていてもよい。この場合、全ての構成要素を貼付シートに一体化することができる。貼付シートを皮膚に貼ることにより、皮膚穿刺用針状デバイスを皮膚に刺した状態で固定することができる。また、貼付シートを貼った状態で、生体成分の測定や分析を行うことができる。これにより、日常の諸活動や行動中でも、外れることなく、継続して生体成分を測定することができる。構成要素を小型化することにより、貼付シートを貼った状態でも気にならず、装着感、違和感が極めて小さく、手軽に生体成分の測定を行うことができる。皮膚穿刺用針状デバイスが生体成分回収用デバイスから成る場合、透析液タンク、送液ポンプ、測定手段および排液タンクが、貼付シートの他方の面側に取り付けられる。また、導通孔に光を通して真皮や皮下組織を通った光を測定する場合、発光手段および光測定手段が、貼付シートの他方の面側に取り付けられる。
The biological component measurement system according to the present invention has an adhesive sheet having an adhesive layer on one side, and the skin puncture needle-like device is attached to the adhesive sheet so that a tip portion protrudes from the adhesive layer. In addition, the parts other than the needle puncture device for skin puncture may be attached to the other surface side of the adhesive sheet. In this case, all the components can be integrated into the sticking sheet. By sticking the patch sheet to the skin, the needle-like device for skin puncture can be fixed in a state of being stabbed into the skin. Moreover, a biological component can be measured and analyzed in a state where an adhesive sheet is attached. Thereby, even during daily activities and actions, it is possible to continuously measure the biological components without losing. By downsizing the constituent elements, it is possible to easily measure the biological components without feeling bothered even when the sticking sheet is pasted, with extremely little wearing feeling and uncomfortable feeling. When the skin puncture needle-like device is composed of a biological component recovery device, the dialysate tank, the liquid feed pump, the measuring means, and the drainage tank are attached to the other side of the adhesive sheet. When light passing through the conduction hole and passing through the dermis or subcutaneous tissue is measured, the light emitting means and the light measuring means are attached to the other surface side of the adhesive sheet.

本発明によれば、刺すだけで容易に設置可能で、穿刺の際の痛みが小さく、継続して生体成分を測定することができる皮膚穿刺用針状デバイス、生体成分回収用デバイスおよび生体成分測定システムを提供することができる。
According to the present invention, the needle-like device for skin puncture, which can be easily installed just by puncturing, has little pain during puncture, and can continuously measure a biological component, a biological component recovery device, and a biological component measurement A system can be provided.

本発明の実施の形態の生体成分測定システムの使用状態を示す(a)ブロック図、(b)生体成分回収用デバイスの先端部の一部拡大断面図である。It is the (a) block diagram which shows the use condition of the biological component measuring system of embodiment of this invention, (b) A partial expanded sectional view of the front-end | tip part of the biological component collection | recovery device. 本発明の実施の形態の生体成分測定システムを示す(a)使用状態の斜視図、(b)斜視図、(c)A−A’線断面図である。BRIEF DESCRIPTION OF THE DRAWINGS (a) The perspective view of a use condition which shows the biological component measuring system of embodiment of this invention, (b) A perspective view, (c) A-A 'sectional view taken on the line. 図2に示す生体成分測定システムの生体成分回収用デバイスの製造工程を示す横断面図である。It is a cross-sectional view which shows the manufacturing process of the biological component collection | recovery device of the biological component measuring system shown in FIG. 本発明の実施の形態の生体成分測定システムの、生体成分回収用デバイスの変形例を示す斜視図である。It is a perspective view which shows the modification of the device for biological component collection | recovery of the biological component measuring system of embodiment of this invention. 本発明の実施の形態の生体成分測定システムの、生体成分回収用デバイスの回収機能を確認する実験態様を示す概略側面図である。It is a schematic side view which shows the experiment aspect which confirms the collection | recovery function of the biological component collection | recovery device of the biological component measurement system of embodiment of this invention. 図5に示す実験により得られた、回収された透析液の乳酸濃度(回収液乳酸濃度)と標準液乳酸濃度との関係を示すグラフである。6 is a graph showing the relationship between the lactic acid concentration (recovered solution lactic acid concentration) of the collected dialysate and the standard solution lactic acid concentration obtained by the experiment shown in FIG.

以下、図面に基づき、本発明の実施の形態について説明する。
図1乃至図6は、本発明の実施の形態の皮膚穿刺用針状デバイス、生体成分回収用デバイスおよび生体成分測定システムを示している。
図1および図2に示すように、生体成分測定システム10は、貼付シート11と生体成分回収用デバイス12と透析液タンク13と送水チューブ14と送液ポンプ15と排水チューブ16と測定手段(測定部、センサ)17と排液タンク(廃液タンク)18とを有している。
Hereinafter, embodiments of the present invention will be described with reference to the drawings.
FIG. 1 to FIG. 6 show a skin puncture needle device, a biological component collection device, and a biological component measurement system according to an embodiment of the present invention.
As shown in FIGS. 1 and 2, the biological component measurement system 10 includes a patch sheet 11, a biological component recovery device 12, a dialysate tank 13, a water supply tube 14, a liquid supply pump 15, a drainage tube 16, and measurement means (measurement). Part, sensor) 17 and a drainage tank (waste liquid tank) 18.

図2に示すように、貼付シート11は、矩形状の両端が円弧状に形成された細長い形状を成し、市販の絆創膏と同じ程度の大きさを有している。貼付シート11は、一方の面に粘着剤層11aを有しており、粘着剤層11aで皮膚の表面に貼付可能になっている。   As shown in FIG. 2, the sticking sheet 11 has an elongated shape in which both ends of a rectangular shape are formed in an arc shape, and has the same size as a commercially available adhesive bandage. The adhesive sheet 11 has an adhesive layer 11a on one surface, and can be applied to the surface of the skin with the adhesive layer 11a.

図1(b)に示すように、生体成分回収用デバイス12は、皮膚穿刺用針状デバイスから成り、細長い針体21と、表層膜22と導通孔23と複数の透析穴24とを有している。針体21は、先端部の径が小さくて短い市販の鍼灸用の円皮鍼から成っている。なお、具体的な一例では、針体21は、先端部の太さが約0.2〜0.26mm、長さが約0.3〜1.8mmである。
As shown in FIG. 1B, the biological component recovery device 12 is composed of a skin puncture needle-like device, and has an elongated needle body 21, a surface layer film 22, a conduction hole 23, and a plurality of dialysis holes 24. ing. The needle body 21 is composed of a commercially available scissors for scissors with a short tip and a small diameter. In a specific example, the needle body 21 has a tip portion with a thickness of about 0.2 to 0.26 mm and a length of about 0.3 to 1.8 mm.

表層膜22は、ポリイミド製で、針体21の先端部から末端部まで、針体21の長さ方向に沿って、針体21の側面を覆うよう設けられている。なお、表層膜22は、針体21の刺入性が保たれるのであれば、針体21の針先を覆っていてもよい。導通孔23は、針体21の先端側から末端側に伸びるよう、表層膜22に設けられている。導通孔23は、表層膜22の針体21側の面に形成されている。導通孔23は、針体21の末端側に流入口23aと排出口23bとを有し、流入口23aから針体21の先端側まで伸びて排出口23bに循環して戻るよう設けられている。各透析穴24は、表層膜22の針体21の先端側に、外部と導通孔23とを連通するよう設けられている。各透析穴24は、測定対象の生体成分を通過可能な大きさに形成されている。   The surface layer film 22 is made of polyimide and is provided so as to cover the side surface of the needle body 21 along the length direction of the needle body 21 from the distal end portion to the distal end portion of the needle body 21. Note that the surface layer film 22 may cover the needle tip of the needle body 21 as long as the penetration of the needle body 21 is maintained. The conduction hole 23 is provided in the surface layer film 22 so as to extend from the distal end side to the distal end side of the needle body 21. The conduction hole 23 is formed on the surface of the surface layer film 22 on the needle body 21 side. The conduction hole 23 has an inflow port 23a and a discharge port 23b on the end side of the needle body 21, and extends from the inflow port 23a to the tip side of the needle body 21 so as to circulate back to the discharge port 23b. . Each dialysis hole 24 is provided on the distal end side of the needle body 21 of the surface layer film 22 so as to communicate the outside with the conduction hole 23. Each dialysis hole 24 is formed in a size capable of passing the biological component to be measured.

図3に示すように、生体成分回収用デバイス12の表層膜22、導通孔23および各透析穴24は、例えば、以下のようにして形成される。まず、図3(a)に示すように、針体21に、表層膜22として、厚さ約20μmのポリイミド(polyimide)膜を電着する。次に、図3(b)に示すように、レーザーアブレーション(波長355nm)でポリイミド膜に、導通孔23となる流路部分(幅50μm)を作製する。図3(c)に示すように、その流路部分に犠牲層として銅(Cu)を電解めっきし、図3(d)に示すように、その上に、透析膜となるポリイミド膜を薄く電着する。図3(e)に示すように、その透析膜に、レーザーアブレーションを用いて約φ10μmの透析穴24を作製し、図3(f)に示すように、銅の犠牲層をエッチング除去して導通孔23を作製する。   As shown in FIG. 3, the surface layer film 22, the conduction hole 23, and each dialysis hole 24 of the biological component recovery device 12 are formed as follows, for example. First, as shown in FIG. 3A, a polyimide film having a thickness of about 20 μm is electrodeposited on the needle body 21 as the surface layer film 22. Next, as shown in FIG. 3B, a flow path portion (width 50 μm) to be the conduction hole 23 is formed in the polyimide film by laser ablation (wavelength 355 nm). As shown in FIG. 3 (c), copper (Cu) is electroplated as a sacrificial layer on the flow path portion, and as shown in FIG. To wear. As shown in FIG. 3E, a dialysis hole 24 having a diameter of about 10 μm is formed on the dialysis membrane by laser ablation, and the copper sacrificial layer is removed by etching as shown in FIG. Holes 23 are created.

図2(b)および(c)に示すように、生体成分回収用デバイス12は、その先端部が粘着剤層11aから突出するよう、円環部分を貼付シート11の粘着剤層11aとは反対の面に貼り付けて、貼付シート11に取り付けられている。   As shown in FIGS. 2 (b) and 2 (c), the biological component recovery device 12 has an annular portion opposite to the adhesive layer 11a of the adhesive sheet 11 so that the tip portion protrudes from the adhesive layer 11a. Is attached to the adhesive sheet 11.

図1(a)、図2(b)および(c)に示すように、透析液タンク13は、透析液を貯蔵可能に構成され、貼付シート11の粘着剤層11aとは反対側の面の一方の端部に取り付けられている。送水チューブ14は、ポリエチレンチューブから成り、導通孔23の流入口23aと透析液タンク13とを接続するよう設けられている。送液ポンプ15は、透析液タンク13に内蔵され、透析液タンク13の透析液を、送水チューブ14を通して流入口23aから導通孔23に流すよう構成されている。   As shown in FIGS. 1 (a), 2 (b) and 2 (c), the dialysate tank 13 is configured to be able to store dialysate and is provided on the surface of the adhesive sheet 11 opposite to the adhesive layer 11a. It is attached to one end. The water supply tube 14 is made of a polyethylene tube, and is provided so as to connect the inlet 23 a of the conduction hole 23 and the dialysate tank 13. The liquid feed pump 15 is built in the dialysate tank 13 and is configured to flow the dialysate in the dialysate tank 13 from the inlet 23 a to the conduction hole 23 through the water feed tube 14.

排水チューブ16は、ポリエチレンチューブから成り、導通孔23の排出口23bと排液タンク18とを接続するよう設けられている。測定手段17は、測定対象の生体成分を測定可能な酵素センサから成っている。測定手段17は、貼付シート11の粘着剤層11aとは反対側の面の中央部に取り付けられている。測定手段17は、排水チューブ16を流れる透析液に含まれる生体成分を測定可能に設けられている。排液タンク18は、測定手段17で測定された後の透析液を、排水チューブ16から受けて貯蔵するよう構成されている。排液タンク18は、貼付シート11の粘着剤層11aとは反対側の面の他方の端部に取り付けられている。   The drainage tube 16 is made of a polyethylene tube, and is provided so as to connect the discharge port 23 b of the conduction hole 23 and the drainage tank 18. The measuring means 17 is composed of an enzyme sensor capable of measuring a biological component to be measured. The measuring means 17 is attached to the center of the surface of the adhesive sheet 11 opposite to the pressure-sensitive adhesive layer 11a. The measuring means 17 is provided so as to be able to measure a biological component contained in the dialysate flowing through the drainage tube 16. The drainage tank 18 is configured to receive and store the dialysate after being measured by the measuring means 17 from the drainage tube 16. The drainage tank 18 is attached to the other end of the surface of the adhesive sheet 11 opposite to the adhesive layer 11a.

次に、作用について説明する。
生体成分測定システム10は、透析を利用して生体成分を回収して測定を行うことができる。図1および図2に示すように、生体成分測定システム10は、表皮1を貫通して透析穴24が真皮2や皮下組織に位置するよう、生体成分回収用デバイス12の先端部を皮膚に刺して使用される。貼付シート11を皮膚に貼ることにより、生体成分回収用デバイス12を皮膚に刺した状態で固定することができる。皮膚に刺した状態で、透析液タンク13に貯蔵された透析液を、送液ポンプ15により流入口23aから導通孔23に流すことにより、導通孔23に透析液を循環させることができる。この循環により、浸透圧を利用して、皮下組織液中の生体成分を、透析穴24を通して導通孔23の内側の透析液中に回収することができる。これにより、排出口23bから排出された透析液に含まれる生体成分を測定手段17で測定することで、皮下組織液中に含まれると考えられる生体成分を測定することができる。
Next, the operation will be described.
The biological component measurement system 10 can perform measurement by collecting biological components using dialysis. As shown in FIGS. 1 and 2, the biological component measurement system 10 pierces the skin with the tip of the biological component recovery device 12 so that the dialysis hole 24 is located in the dermis 2 or subcutaneous tissue through the epidermis 1. Used. By sticking the patch sheet 11 on the skin, the biological component collecting device 12 can be fixed in a state of being stabbed into the skin. When the dialysate stored in the dialysate tank 13 is pierced into the skin, the dialysate can be circulated through the conduction hole 23 by flowing the dialysate from the inlet 23a to the conduction hole 23 by the liquid feeding pump 15. By this circulation, the biological component in the subcutaneous tissue fluid can be collected into the dialysate inside the conduction hole 23 through the dialysis hole 24 by utilizing the osmotic pressure. Thereby, the biological component contained in the dialysate discharged | emitted from the discharge port 23b is measured by the measurement means 17, and the biological component considered to be contained in a subcutaneous tissue fluid is measurable.

このように、生体成分測定システム10は、生体成分回収用デバイス12を刺すだけで容易に設置可能であり、どこにでも刺して生体成分を測定することができる。また、送液ポンプ15で透析液を連続して送り続けることにより、測定手段17で生体成分を継続的または間欠的に測定することができ、生体成分の経時的な変化を測定することができる。測定後の透析液は、排液タンク18に貯蔵して回収し、廃棄することができる。   As described above, the biological component measurement system 10 can be easily installed simply by pricking the biological component recovery device 12, and can measure the biological component by pricking anywhere. Further, by continuously feeding the dialysate with the liquid feed pump 15, the biological component can be measured continuously or intermittently by the measuring means 17, and the change with time of the biological component can be measured. . The dialysate after the measurement can be stored and recovered in the drainage tank 18 and discarded.

生体成分測定システム10は、全ての構成要素が貼付シート11に一体化されており、貼付シート11を貼った状態で、生体成分の測定を行うことができる。これにより、日常の諸活動や行動中でも、外れることなく、継続して生体成分を測定することができる。全ての構成要素が絆創膏の大きさに収まるよう小型化されているため、貼付シート11を貼った状態でも気にならず、装着感、違和感が極めて小さく、手軽に生体成分の測定を行うことができる。   In the biological component measurement system 10, all components are integrated with the adhesive sheet 11, and the biological component can be measured with the adhesive sheet 11 attached. Thereby, even during daily activities and actions, it is possible to continuously measure the biological components without losing. Since all the constituent elements are miniaturized so as to fit within the size of the adhesive bandage, even when the adhesive sheet 11 is applied, there is little concern about wearing and discomfort, and biological components can be measured easily. it can.

生体成分測定システム10は、測定手段17を、測定対象の生体成分が異なるものに交換することにより、様々な種類の生体成分を測定することができる。また、測定手段17を複数設けることにより、一度に複数種類の生体成分を測定することができる。測定対象の生体成分は、例えば乳酸、グルコース、アルコール、水分、ナトリウムイオンやカリウムイオンなどのイオン、ホルモン成分など、透析により回収可能な生体成分であれば、いかなるものであってもよい。例えば、測定対象の生体成分が乳酸から成る場合には、乳酸濃度との相関が強い運動強度を測定することができる。   The biological component measuring system 10 can measure various types of biological components by exchanging the measuring means 17 with a different measuring target biological component. Further, by providing a plurality of measuring means 17, a plurality of types of biological components can be measured at a time. The biological component to be measured may be any biological component that can be recovered by dialysis, such as lactic acid, glucose, alcohol, water, ions such as sodium ions and potassium ions, and hormone components. For example, when the biological component to be measured is made of lactic acid, it is possible to measure exercise intensity that has a strong correlation with the lactic acid concentration.

生体成分測定システム10は、針体21に鍼灸用の針を利用しているため、穿刺の際の痛みを小さくすることができる。また、径が小さい針を利用しているため、刺したまま日常の諸活動や行動を行っても、生体成分回収用デバイス12が破損したり、出血したりせず、装着感、違和感も極めて小さい。導通孔23が表層膜22に設けられており、針体21を直接加工する必要がないため、製造が容易で、導通孔23を所望の構造に加工しやすい。   Since the biological component measurement system 10 uses a needle for acupuncture as the needle body 21, it can reduce pain during puncture. In addition, since a needle with a small diameter is used, the biological component recovery device 12 does not break or bleed even if daily activities and actions are carried out while being stabbed, and the wearing feeling and discomfort are extremely high. small. Since the conduction hole 23 is provided in the surface layer film 22 and it is not necessary to directly process the needle body 21, manufacturing is easy and the conduction hole 23 is easily processed into a desired structure.

なお、透析液は、皮下組織液との間で透析を行うことができ、回収した生体成分を分析可能であれば、いかなる成分から成っていてもよい。分子量の大きいタンパク質等が導通孔23に入り込むと、導通孔23が詰まったり、乳酸等の生体成分の代謝が起こったり、測定手段17の酵素電極にタンパク質等が付着して連続測定が行えなくなったりするため、透析穴24は、測定対象の低分子量の生体成分が通過し、タンパク質等が通過しない、数十ナノメートル程度の径を有していることが好ましい。   The dialysate may be composed of any component as long as it can be dialyzed against the subcutaneous tissue fluid and the collected biological component can be analyzed. When proteins having a large molecular weight enter the conduction hole 23, the conduction hole 23 is clogged, metabolism of biological components such as lactic acid occurs, or protein or the like adheres to the enzyme electrode of the measuring means 17 and continuous measurement cannot be performed. Therefore, it is preferable that the dialysis hole 24 has a diameter of about several tens of nanometers through which a low molecular weight biological component to be measured passes and proteins do not pass.

また、図4に示すように、生体成分回収用デバイス12は、針体21が、直径0.2mmの細長い鍼灸針(例えば、セイリン株式会社製の鍼)から成っていてもよい。この場合にも、穿刺の際の痛みが小さく、出血しにくい。生体成分測定システム10は、例えば、測定手段17で測定した結果に応じて色が変化したり、測定値を表示したりする表示手段を有していてもよい。   As shown in FIG. 4, in the biological component collecting device 12, the needle body 21 may be formed of an elongated needle having a diameter of 0.2 mm (for example, a needle made by Seirin Co., Ltd.). Also in this case, pain during puncture is small and bleeding is difficult. For example, the biological component measurement system 10 may include a display unit that changes the color or displays a measurement value according to a result measured by the measurement unit 17.

また、生体成分測定システム10は、貼付シート11を使用して一体化されていなくてもよく、透析液タンク13や送液ポンプ15、排液タンク(廃液タンク)18がシリンジなどを利用して構成されていてもよい。このような場合であっても、生体成分回収用デバイス12を用いることにより、生体成分を回収して測定を行うことができる。生体成分測定システム10は、針体21または表層膜22に、電位を測定するための電極パターンが形成されていてもよい。この場合、神経電位や筋電位と生体成分測定とを組み合わせることができる。   Further, the biological component measurement system 10 may not be integrated using the adhesive sheet 11, and the dialysate tank 13, the liquid feed pump 15, and the drainage tank (waste liquid tank) 18 use a syringe or the like. It may be configured. Even in such a case, the biological component can be collected and measured by using the biological component collecting device 12. In the biological component measurement system 10, an electrode pattern for measuring a potential may be formed on the needle body 21 or the surface layer film 22. In this case, nerve potential or myoelectric potential can be combined with biological component measurement.

また、生体成分測定システム10は、皮膚穿刺用針状デバイスが生体成分回収用デバイス12ではなく、光測定用のデバイスから成っており、導通孔23が1対から成り、それぞれ光を通過可能に構成され、針体21の先端側に開口を有しており、針体21の末端側から一方の導通孔23に光を通す発光手段と、針体21の末端側で他方の導通孔23を通る光を測定する光測定手段とを、有していてもよい。これらの場合、発光手段から発して真皮2や皮下組織を通った光を、光測定手段で測定することができる。この測定結果を利用して、スペクトル解析等を行うことにより、真皮2や皮下組織中の生体成分の分析を行うことができる。各導通孔23は、光を効率良く通すよう、例えば、内部にSiOを充填したSiO光導波路から成っていてもよい。
Further, in the biological component measurement system 10, the skin puncture needle-like device is not the biological component collection device 12, but a device for measuring light, and the conduction holes 23 are made of a pair so that light can pass through each device. A light emitting means configured to pass light from the distal end side of the needle body 21 to the one conduction hole 23; and the other conduction hole 23 on the distal end side of the needle body 21. You may have the light measurement means which measures the light which passes. In these cases, light emitted from the light emitting means and passed through the dermis 2 or the subcutaneous tissue can be measured by the light measuring means. By using this measurement result and performing spectral analysis, it is possible to analyze biological components in the dermis 2 and subcutaneous tissue. Each conduction hole 23 may be made of, for example, a SiO 2 optical waveguide filled with SiO 2 so as to efficiently transmit light.

図5に示すように、生体成分回収用デバイス12の回収機能を確認するために、リン酸緩衝液に乳酸を混ぜた標準液(乳酸標準液)を作製し、それを用いて乳酸が回収できるかどうかの確認実験を行った。図4に示す生体成分回収用デバイス12を用い、測定対象の生体成分を乳酸とし、測定手段17として乳酸を測定可能な酵素センサを用いた。また、透析液として、生理食塩水を用いた。   As shown in FIG. 5, in order to confirm the recovery function of the biological component recovery device 12, a standard solution (lactic acid standard solution) in which lactic acid is mixed with a phosphate buffer solution is prepared, and lactic acid can be recovered using the standard solution. A confirmation experiment was conducted. The biological component recovery device 12 shown in FIG. 4 was used, and the biological component to be measured was lactic acid, and the measurement means 17 was an enzyme sensor capable of measuring lactic acid. Moreover, physiological saline was used as the dialysate.

実験では、まず、透析穴24が標準液の内部に配置されるよう、生体成分回収用デバイス12の先端部を標準液に浸した。次に、透析液をシリンジポンプから流入口23aを通して導通孔23に供給し、導通孔23に透析液を循環させ、導通孔23を循環した透析液を、排出口23bから回収シリンジに回収した。このとき、導通孔23の排出口23bの側を回収シリンジで陰圧にすることにより、透析液をより集めやすくした。   In the experiment, first, the tip of the biological component collection device 12 was immersed in the standard solution so that the dialysis hole 24 was disposed inside the standard solution. Next, the dialysate was supplied from the syringe pump to the conduction hole 23 through the inlet 23a, the dialysate was circulated through the conduction hole 23, and the dialysate circulated through the conduction hole 23 was collected from the discharge port 23b to the collection syringe. At this time, the side of the discharge port 23b of the conduction hole 23 was set to a negative pressure with a recovery syringe, thereby making it easier to collect the dialysate.

透析液を10分間流した後、回収された透析液の乳酸濃度を、市販の血中乳酸濃度センサ(製品名「ラクテート・プロ」、アークレイ株式会社製)を用いて測定した。標準液の乳酸濃度は、リン酸緩衝液のみの0mmol/リットル、安静時の血中乳酸濃度の目安である1mmol/リットル、運動時の血中乳酸濃度の目安の6mmol/リットルの3種類を用いた。   After flowing the dialysate for 10 minutes, the lactic acid concentration of the collected dialysate was measured using a commercially available blood lactic acid concentration sensor (product name “Lactate Pro”, manufactured by ARKRAY, Inc.). Three standard lactate concentrations are available: 0 mmol / liter of phosphate buffer only, 1 mmol / liter, which is a measure of resting blood lactate concentration, and 6 mmol / liter, a measure of blood lactate concentration during exercise. It was.

回収された各透析液の乳酸濃度の測定値と、各標準液を市販の血中乳酸濃度センサで測定したときの乳酸濃度との関係を、図6に示す。図6に示すように、回収された各透析液の乳酸濃度と各標準液の乳酸濃度とはほぼ同じ値を示しており、生体成分回収用デバイス12により乳酸が回収できていることが確認された。   FIG. 6 shows the relationship between the measured value of the lactic acid concentration of each collected dialysate and the lactic acid concentration when each standard solution was measured with a commercially available blood lactic acid concentration sensor. As shown in FIG. 6, the lactic acid concentration of each collected dialysis solution and the lactic acid concentration of each standard solution show almost the same value, and it was confirmed that lactic acid could be collected by the biological component collection device 12. It was.

生体成分回収用デバイス12を皮下に刺入した状態で運動が可能かどうかを確認するために、マウスを用いて実験を行った。生体成分回収用デバイス12として、図4に示すものを用いた。マウスの背部の毛を一部剃毛し、そこに生体成分回収用デバイス12を刺入した。その後、テープで生体成分回収用デバイス12をマウスに固定し、マウスにトレッドミル(15m/min)で15分間の運動を行わせた。運動終了後、生体成分回収用デバイス12の表層膜22などが破損していないか、および、マウスの皮膚に影響がないかを確認した。   In order to confirm whether or not exercise is possible with the biological component collection device 12 inserted subcutaneously, an experiment was performed using a mouse. As the biological component recovery device 12, the device shown in FIG. 4 was used. The hair on the back of the mouse was partially shaved, and the biological component collection device 12 was inserted there. Thereafter, the biological component collection device 12 was fixed to the mouse with a tape, and the mouse was allowed to exercise for 15 minutes with a treadmill (15 m / min). After the exercise, it was confirmed whether the surface layer film 22 and the like of the biological component collection device 12 were not damaged and whether the mouse skin was affected.

その結果、マウスの運動後であっても、表層膜22の破損等は認められず、マウスの刺入部分の皮膚にも出血等は認められなかった。このことから、生体成分回収用デバイス12を刺したまま運動等を行っても、針体21や表層膜22などが破損したり、出血したりしにくいことが確認された。   As a result, even after the movement of the mouse, no damage or the like of the surface layer film 22 was observed, and no bleeding or the like was observed in the skin of the inserted portion of the mouse. From this, it was confirmed that even if exercise or the like is performed with the living body component collecting device 12 stabbed, the needle body 21 and the surface layer film 22 are not easily damaged or bleeding.

1 表皮
2 真皮
10 生体成分測定システム
11 貼付シート
11a 粘着剤層
12 生体成分回収用デバイス
21 針体
22 表層膜
23 導通孔
23a 流入口
23b 排出口
24 透析穴
13 透析液タンク
14 送水チューブ
15 送液ポンプ
16 排水チューブ
17 測定手段
18 排液タンク
DESCRIPTION OF SYMBOLS 1 Epidermis 2 Dermis 10 Biological component measurement system 11 Adhesive sheet 11a Adhesive layer 12 Biological component collection device 21 Needle body 22 Surface layer 23 Conductive hole 23a Inflow port 23b Outlet port 24 Dialysis hole 13 Dialysate tank 14 Water supply tube 15 Liquid supply Pump 16 Drain tube 17 Measuring means 18 Drain tank

Claims (8)

断面が円形である円形断面を有する針から成る針体と、
前記針体の長さ方向に沿って、前記針体の少なくとも前記円形断面部分の側面に設けられた表層膜と、
前記針体の長手方向に伸びるよう前記表層膜に設けられた導通孔とを有し、
前記導通孔は、前記針体を皮膚に刺したとき、真皮または皮下組織まで達し、前記皮下組織液中の生体成分を回収または測定することができるよう設けられていることを
特徴とする皮膚穿刺用針状デバイス。
A needle body comprising a needle having a circular cross section with a circular cross section ;
A surface layer film provided on a side surface of at least the circular cross section of the needle body along the length direction of the needle body,
A conduction hole provided in the surface layer film to extend in the longitudinal direction of the needle body ,
The conduction hole is provided so as to reach the dermis or subcutaneous tissue when the needle is stabbed into the skin and collect or measure a biological component in the subcutaneous tissue fluid.
A needle-like device for skin puncture.
前記導通孔は、前記針体の側面に複数条設けられていることを特徴とする請求項1記載の皮膚穿刺用針状デバイス The needle-like device for skin puncture according to claim 1, wherein a plurality of the conductive holes are provided on a side surface of the needle body . 透析を利用して生体成分を回収するための皮膚穿刺用針状デバイスであって、A needle-like device for skin puncture for collecting biological components using dialysis,
前記導通孔は、透析液および生体成分を通過可能であり、The conduction hole is capable of passing dialysate and biological components,
前記表層膜は、前記針体を皮膚に刺したとき、真皮または皮下組織まで達する位置に、前記生体成分を通過可能に前記導通孔に連通するよう設けられた1または複数の透析穴を有することをThe surface layer film has one or a plurality of dialysis holes provided to communicate with the conduction hole so that the biological component can pass through at a position reaching the dermis or subcutaneous tissue when the needle body is pierced into the skin. The
特徴とする請求項1または2記載の皮膚穿刺用針状デバイス。The needle-like device for skin puncture according to claim 1 or 2.
透析を利用して生体成分を回収するための生体成分回収用デバイスであって、
請求項1乃至3のいずれか1項に記載の皮膚穿刺用針状デバイスを有し、
前記導通孔は、前記針体を皮膚に刺したとき、表皮より外側の位置に流入口と排出口とを有し、前記流入口から、前記針体を皮膚に刺したとき、真皮または皮下組織まで達する位置まで伸びて前記排出口に循環して戻るよう設けられ、
前記表層膜は、前記針体を皮膚に刺したとき、真皮または皮下組織まで達する位置に、前記生体成分を通過可能に前記導通孔に連通するよう設けられた1または複数の透析穴を有することを
特徴とする生体成分回収用デバイス。
A biological component recovery device for recovering biological components using dialysis,
A needle-like device for skin puncture according to any one of claims 1 to 3 ,
The conduction hole has an inlet and an outlet at a position outside the epidermis when the needle is stabbed into the skin, and when the needle is stabbed into the skin from the inlet , the dermis or subcutaneous tissue It is provided to extend to a position reaching up to and circulate back to the outlet,
The surface layer film has one or a plurality of dialysis holes provided to communicate with the conduction hole so that the biological component can pass through at a position reaching the dermis or subcutaneous tissue when the needle body is pierced into the skin. A biological component recovery device characterized by the following.
請求項4記載の生体成分回収用デバイスと、
透析液を貯蔵し、前記流入口に接続された透析液タンクと、
前記透析液タンクの前記透析液を前記流入口から前記導通孔に流すための送液ポンプと、
前記導通孔を通って前記排出口から排出された前記透析液に含まれる前記生体成分を測定可能に設けられた測定手段と、
前記測定手段で測定された後の前記透析液を貯蔵する排液タンクとを、
有することを特徴とする生体成分測定システム。
The biological component recovery device according to claim 4 ,
A dialysate tank for storing dialysate and connected to the inlet;
A liquid feed pump for flowing the dialysate in the dialysate tank from the inlet to the conduction hole;
Measuring means provided so as to be able to measure the biological component contained in the dialysate discharged from the outlet through the conduction hole;
A drainage tank for storing the dialysate after being measured by the measuring means;
A biological component measurement system comprising:
前記導通孔は1対から成り、それぞれ光を通過可能に構成され、前記針体を皮膚に刺したとき、真皮または皮下組織まで達する位置に開口を有していることを特徴とする請求項1または2記載の皮膚穿刺用針状デバイス。 The through hole consists of a pair, is passed configured to enable light respectively, when stabbed the needle body to the skin, claim 1, characterized in that has an opening at a position reaching the dermis or subcutaneous tissue Or a needle-like device for skin puncture according to 2 . 請求項6記載の皮膚穿刺用針状デバイスと、
前記針体を皮膚に刺したとき、表皮より外側の位置から一方の導通孔に光を通す発光手段と、
前記針体を皮膚に刺したとき、表皮より外側の位置で他方の導通孔を通る光を測定する光測定手段とを、
有することを特徴とする生体成分測定システム。
A needle-like device for skin puncture according to claim 6 ,
When the needle body is stabbed into the skin, a light emitting means for passing light from one position outside the epidermis to one conduction hole;
A light measuring means for measuring light passing through the other conduction hole at a position outside the epidermis when the needle is stabbed into the skin ;
A biological component measurement system comprising:
一方の面に粘着剤層を有する貼付シートを有し、
前記皮膚穿刺用針状デバイスは、先端部が前記粘着剤層から突出するよう前記貼付シートに取り付けられ、
前記皮膚穿刺用針状デバイス以外の部品は、前記貼付シートの他方の面側に取り付けられていることを
特徴とする請求項5または7記載の生体成分測定システム。
Having a patch sheet with an adhesive layer on one side,
The needle-like device for skin puncture is attached to the adhesive sheet so that the tip protrudes from the adhesive layer,
The biological component measurement system according to claim 5 or 7 , wherein parts other than the needle- puncture device for skin puncture are attached to the other surface side of the adhesive sheet.
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