JP2000000231A - Lancet-integrated body fluid measurement device and mounted body used by attaching to this body fluid measurement device - Google Patents
Lancet-integrated body fluid measurement device and mounted body used by attaching to this body fluid measurement deviceInfo
- Publication number
- JP2000000231A JP2000000231A JP10166894A JP16689498A JP2000000231A JP 2000000231 A JP2000000231 A JP 2000000231A JP 10166894 A JP10166894 A JP 10166894A JP 16689498 A JP16689498 A JP 16689498A JP 2000000231 A JP2000000231 A JP 2000000231A
- Authority
- JP
- Japan
- Prior art keywords
- body fluid
- puncture
- main body
- measuring device
- terminal
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
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- 239000010839 body fluid Substances 0.000 title claims abstract description 54
- 238000005259 measurement Methods 0.000 title claims abstract description 29
- 230000007246 mechanism Effects 0.000 claims abstract description 12
- 238000006243 chemical reaction Methods 0.000 claims description 41
- 239000003153 chemical reaction reagent Substances 0.000 claims description 19
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- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 21
- 239000008103 glucose Substances 0.000 description 21
- 238000003825 pressing Methods 0.000 description 16
- 239000010410 layer Substances 0.000 description 15
- 238000012360 testing method Methods 0.000 description 11
- 230000009471 action Effects 0.000 description 7
- -1 potassium ferricyanide Chemical compound 0.000 description 6
- 239000011347 resin Substances 0.000 description 6
- 229920005989 resin Polymers 0.000 description 6
- 210000000624 ear auricle Anatomy 0.000 description 5
- 238000003487 electrochemical reaction Methods 0.000 description 5
- 238000006911 enzymatic reaction Methods 0.000 description 5
- 108091006149 Electron carriers Proteins 0.000 description 4
- 108010015776 Glucose oxidase Proteins 0.000 description 3
- 239000004366 Glucose oxidase Substances 0.000 description 3
- 108090000854 Oxidoreductases Proteins 0.000 description 3
- 102000004316 Oxidoreductases Human genes 0.000 description 3
- 229940116332 glucose oxidase Drugs 0.000 description 3
- 235000019420 glucose oxidase Nutrition 0.000 description 3
- 229910052751 metal Inorganic materials 0.000 description 3
- 239000002184 metal Substances 0.000 description 3
- 238000000034 method Methods 0.000 description 3
- 238000012986 modification Methods 0.000 description 3
- 230000004048 modification Effects 0.000 description 3
- 239000000276 potassium ferrocyanide Substances 0.000 description 3
- XOGGUFAVLNCTRS-UHFFFAOYSA-N tetrapotassium;iron(2+);hexacyanide Chemical compound [K+].[K+].[K+].[K+].[Fe+2].N#[C-].N#[C-].N#[C-].N#[C-].N#[C-].N#[C-] XOGGUFAVLNCTRS-UHFFFAOYSA-N 0.000 description 3
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- 108090000790 Enzymes Proteins 0.000 description 2
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- JOYRKODLDBILNP-UHFFFAOYSA-N Ethyl urethane Chemical compound CCOC(N)=O JOYRKODLDBILNP-UHFFFAOYSA-N 0.000 description 2
- 229940088598 enzyme Drugs 0.000 description 2
- 239000012530 fluid Substances 0.000 description 2
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- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 description 1
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Landscapes
- Sampling And Sample Adjustment (AREA)
- Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
Abstract
(57)【要約】
【課題】測定のために患者に求められる動作をより簡単
なものとして使い勝手をさらに高めることができるとと
もに、必要検体量を著しく低減して測定の確実性を高め
ることができる体液測定装置を提供する。
【解決手段】本体20と、この本体20に装着して使用する
装着体30とを備えた体液測定装置10であって、上記装着
体30は、皮膚当接面35ａと、この皮膚当接面35ａに沿う
ように配置されたセンサ36と、尖端が皮膚当接面35ａか
ら突出する進出位置と尖端が皮膚当接面35ａから没入す
る退避位置との間を移動可能であり、かつ弾性体37によ
って退避位置側に付勢されている穿刺体31とを備えてお
り、上記本体20は、上記装着体30が装着されたときにこ
の装着体30が備えるセンサ36の各電極36ｆ，36ｈに接触
してこれらに導通する端子25ａ, 25ａ、この端子25ａ,
25ａを介して得られる電気信号に基づいて測定値を決定
する電子回路33、および、上記穿刺体31を前進駆動して
この穿刺体に進出位置をとらせるための駆動機構23，32
を備える。
(57) [Summary] [Problem] It is possible to further improve the usability by simplifying the operation required of a patient for measurement, and to improve the reliability of measurement by significantly reducing the required sample amount. Provided is a body fluid measurement device. A body fluid measurement device including a main body and a mounting body used by being mounted on the main body, wherein the mounting body includes a skin contact surface and a skin contact surface. An elastic body 37 which is movable between a sensor 36 disposed along the surface 35a and a retracted position in which the tip projects from the skin contact surface 35a and a point where the tip projects from the skin contact surface 35a. The main body 20 contacts the electrodes 36f and 36h of the sensor 36 provided in the mounting body 30 when the mounting body 30 is mounted. And the terminals 25a, 25a, which conduct to these,
An electronic circuit 33 for determining a measured value based on an electric signal obtained via the electric signal 25a, and a driving mechanism 23, 32 for driving the puncture body 31 forward to cause the puncture body to assume an advanced position.
Is provided.
Description
【０００１】[0001]
【発明の属する技術分野】本願発明は、血中グルコース
濃度（以下、「血糖値」という。）等、体液に含まれる
被検知物質を測定することができ、なおかつ、皮膚から
の体液採集と測定とを一体の操作によって行うことがで
きるように構成された、ランセット一体型の体液測定装
置に関する。BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention can measure a substance to be detected contained in a body fluid, such as a blood glucose concentration (hereinafter, referred to as "blood glucose level"), and collect and measure a body fluid from the skin. The present invention relates to a lancet-integrated body fluid measurement device which is configured to be able to be performed by an integral operation.
【０００２】[0002]
【発明の背景】糖尿病の治療には、患者の血糖値を正常
範囲に保つことが必要であり、患者自らによる血糖値管
理が重要な治療法である。とくに、患者自身によるイン
スリン注射によって血糖値を正常範囲に維持する場合に
は、患者自身による適宜の血糖値測定が欠かせない。BACKGROUND OF THE INVENTION The treatment of diabetes requires the maintenance of a patient's blood sugar level in a normal range, and the control of the blood sugar level by the patient himself is an important treatment. In particular, when the blood glucose level is maintained in a normal range by the injection of insulin by the patient himself, proper measurement of the blood glucose level by the patient himself is indispensable.
【０００３】このような目的に使用する携帯型の血糖値
測定装置がすでに市販されており、その一例は、たとえ
ば特公平８−２０４１２号公報に示されている。この血
糖値測定装置は、酵素電極を有する使い捨て式の試験片
を本体に挿着して使用される。試験片に検体である血液
を触れさせると、その血液の一部が毛管現象により反応
部に引き込まれ、酵素反応および電気化学反応を介して
陽極電流が生じる。この陽極電流が装置本体内で血糖値
に換算され、表示される。A portable blood glucose measuring device used for such a purpose is already commercially available, and an example thereof is disclosed in, for example, Japanese Patent Publication No. 8-20412. This blood glucose level measuring device is used by inserting a disposable test piece having an enzyme electrode into a main body. When blood, which is a specimen, is brought into contact with the test piece, a part of the blood is drawn into the reaction part by capillary action, and an anodic current is generated through an enzyme reaction and an electrochemical reaction. This anode current is converted into a blood glucose level in the apparatus main body and displayed.
【０００４】ところで、上記のような測定装置の試験片
に接触させる検体、すなわち血液の採取は、たとえば特
開平９−２６６８９８号公報に示されているような、ラ
ンセットと呼ばれる器具を用いて行うのが一般的であ
る。このランセットは、患者の指先等の皮膚に小さな孔
を開ける（傷をつける）ための器具であり、こうして開
けられた孔から出液させた血液を上記した試験片の所定
の部位に触れさせることにより、比較的簡便に血糖値の
自己測定をすることができる。[0004] By the way, the sample to be brought into contact with the test piece of the measuring apparatus as described above, that is, blood, is collected by using an instrument called a lancet as disclosed in, for example, Japanese Patent Application Laid-Open No. 9-266898. Is common. This lancet is a device for making a small hole (scratching) in the skin such as a fingertip of a patient, and allows blood discharged from the hole thus made to touch a predetermined portion of the above-described test piece. Thereby, the self-measurement of the blood sugar level can be performed relatively easily.
【０００５】しかしながら、上記した従来一般的な血糖
値自己測定方法においては、検体である血液を採取する
ためのランセットと測定装置とが別体であるが故に、両
者を携行せねばならない不便さとあいまって、ランセッ
トによって皮膚に傷をつける動作と、傷から出液した血
液を試験片に触れさせるという動作との二つの動作をす
る必要があり、使い勝手においていまだ改善の余地があ
る。とりわけ、試験片に血液を触れさせる動作について
は、必要量の血液を試験片の定められた部位に触れさせ
る必要があり、不慣れな患者、あるいは視力が低下した
患者にとってこのような動作を行う場合、あるいは本人
が直接視認できない耳たぶから採血する場合には、上記
したような傷から出液させた血液を迅速適正に試験片に
触れさせることはきわめて困難である。[0005] However, in the above-mentioned conventional general method of self-measurement of blood glucose level, the lancet for collecting blood, which is a specimen, and the measuring device are separate bodies, which is inconvenient in that both must be carried. Therefore, it is necessary to perform two operations, an operation of injuring the skin with a lancet and an operation of contacting the test piece with blood discharged from the wound, and there is still room for improvement in usability. In particular, for the operation of bringing blood into contact with the test piece, it is necessary to bring a required amount of blood into a predetermined part of the test piece, and such an operation is performed for an inexperienced patient or a patient with reduced vision. Alternatively, when blood is collected from an earlobe that cannot be directly recognized by the individual, it is extremely difficult to make the blood discharged from the above-described wound touch the test piece quickly and properly.
【０００６】また、試験片は、先端の孔から反応部に設
けた面的な酵素電極に毛管現象によって血液を引き込む
ように構成されているため、必要量の血液を反応部に到
達させるには、３〜５μｌの血液を試験片に触れさせる
必要がある。この血液量が不足すると、あるいはこの量
の血液が試験片の先端孔を囲むわずかな領域に適正に付
着させられないと、正確な測定ができなくなってしまう
虞れがある。特に幼児や老人等、傷から出液させる血液
量が充分でない場合には、このような事態が頻発しう
る。Further, since the test piece is configured to draw blood by capillary action from a hole at the tip to a planar enzyme electrode provided in the reaction part, it is necessary to allow a necessary amount of blood to reach the reaction part. It is necessary to allow 3-5 μl of blood to touch the test strip. If the amount of blood is insufficient, or if this amount of blood is not properly adhered to a small area surrounding the distal end hole of the test piece, accurate measurement may not be performed. In particular, when the volume of blood to be drained from the wound is insufficient, such as in infants and the elderly, such a situation can occur frequently.
【０００７】上記のような不具合を一応解決しようとす
るものとして、特開平１０−２８６８３号公報には、装
置に組み込まれたランセットによって皮膚に傷をつける
操作を行うだけで、装置に組み込まれたセンサが皮膚か
ら出液した血液の測定を行うようにした、ランセット一
体型血糖値測定器が提案されている。しかしながら、同
公報に示されたものは、使用に際してランセット針とセ
ンサとを別々に装置の所定位置にセットせねばならず、
使い勝手の面でいまだ改善の余地が残されている。As an attempt to solve the above problems, Japanese Patent Laid-Open Publication No. Hei 10-28683 discloses a method in which a lancet is incorporated into an apparatus simply by performing an operation of injuring the skin. A lancet-integrated blood glucose meter has been proposed in which a sensor measures the blood discharged from the skin. However, the one disclosed in the publication requires that the lancet needle and the sensor be separately set at a predetermined position of the device when used,
There is still room for improvement in terms of usability.
【０００８】本願発明は、このような事情のもとで考え
出されたものであって、測定のために患者に求められる
動作をより簡単なものとして使い勝手をさらに高めるこ
とができるとともに、必要検体量を著しく低減して測定
の確実性を高めることができるランセット一体型体液測
定装置を提供することをその課題としている。The present invention has been conceived in view of such circumstances, and the operation required of a patient for measurement can be simplified to further improve the usability, and the required sample can be further improved. It is an object of the present invention to provide a lancet-integrated body fluid measurement device capable of significantly reducing the amount and increasing the reliability of measurement.
【０００９】[0009]
【発明の開示】上記の課題を解決するため、本願発明で
は、次の技術的手段を講じている。DISCLOSURE OF THE INVENTION In order to solve the above problems, the present invention employs the following technical means.
【００１０】本願発明によって提供される体液測定装置
は、本体と、この本体に装着して使用する装着体とを備
えた体液測定装置であって、上記装着体は、皮膚当接面
と、この皮膚当接面に沿うように配置されたセンサと、
尖端が皮膚当接面から突出する進出位置と尖端が皮膚当
接面から没入する退避位置との間を移動可能であり、か
つ弾性体によって退避位置側に付勢されている穿刺体と
を備えており、上記本体は、上記装着体が装着されたと
きにこの装着体が備えるセンサの各電極に接触してこれ
らに導通する端子、この端子を介して得られる電気信号
に基づいて測定値を決定する電子回路、および、上記穿
刺体を前進駆動してこの穿刺体に進出位置をとらせるた
めの駆動機構を備えていることを特徴としている。A body fluid measuring device provided by the present invention is a body fluid measuring device including a main body and a mounting body to be used by being mounted on the main body, wherein the mounting body includes a skin contact surface, A sensor arranged along the skin contact surface,
A puncture body that is movable between an advanced position where the point protrudes from the skin contact surface and a retracted position where the point is retracted from the skin contact surface, and is urged toward the retracted position by an elastic body; The main body, when the mounting body is mounted, a terminal that comes into contact with and conducts to each electrode of the sensor provided in the mounting body, a measurement value based on an electric signal obtained through this terminal. An electronic circuit for determining, and a drive mechanism for driving the puncture body forward to cause the puncture body to assume an advanced position are provided.
【００１１】装着体は、たとえば使い捨て消耗品として
提供される。測定にあたって使用者は、上記装着体を本
体に装着する。皮膚当接面を指先や耳たぶ等の皮膚に押
し当てながら本体の駆動機構を作動さると、退避位置に
ある穿刺体が進出させられてその尖端が皮膚当接面から
突出し、皮膚に傷を付ける。次の瞬間弾性体の作用によ
って穿刺体は退避位置に戻る。装置をそのままの状態に
保持しておくと、皮膚から出液した血液がセンサに浸透
し、センサは反応電流を出力する。この電流は電子回路
によって血液中の特定成分濃度に換算され、たとえば本
体表面に配置された表示器に表示される。The mounting body is provided, for example, as a disposable consumable. At the time of measurement, the user mounts the mounting body on the main body. When the drive mechanism of the main body is actuated while pressing the skin contact surface against the skin such as a fingertip or an earlobe, the puncture body at the retracted position is advanced, and its tip protrudes from the skin contact surface, thereby damaging the skin. . The puncture body returns to the retracted position by the action of the elastic body at the next moment. If the device is kept as it is, blood flowing out of the skin penetrates the sensor, and the sensor outputs a reaction current. This electric current is converted into a specific component concentration in blood by an electronic circuit, and is displayed on, for example, a display arranged on the surface of the main body.
【００１２】このように、本願発明の体液測定装置にお
いては、その装着体にあらかじめ穿刺体とセンサとが一
体に組み込まれているので、使用者は、測定にあたり、
装着体を本体に装着すればよく、ランセットと測定装置
とを別々に用いる場合と比較すればもちろんのこと、ラ
ンセット針とセンサとを別個に装置の所定の部位にセッ
トする必要のある従来のランセット一体型血液測定装置
に比較しても、その使い勝手が著しく向上する。As described above, in the body fluid measuring device of the present invention, since the puncture body and the sensor are integrated into the mounting body in advance, the user needs
A conventional lancet that requires the lancet needle and the sensor to be separately set at a predetermined portion of the device, as well as comparing the case where the lancet and the measuring device are used separately as well as mounting the mounting body on the main body. The usability is remarkably improved as compared with the integrated blood measuring device.
【００１３】好ましい実施の形態においては、上記装着
体における皮膚当接面には、皮膚に負圧を作用させるた
めの開口が形成されている。このように構成すると、皮
膚表面を鬱血状態として穿刺体により傷を付けることが
できるので、充分な量の血液を出液させることができ、
測定がより確実なものとなる。In a preferred embodiment, an opening for applying a negative pressure to the skin is formed on the skin contact surface of the wearing body. With this configuration, the skin surface can be injured by the puncture body in a congested state, so that a sufficient amount of blood can be discharged,
Measurement is more reliable.
【００１４】好ましい実施の形態においてはまた、上記
装着体におけるセンサは、全体として上記皮膚当接面に
沿うように延びる板状を呈しているとともに、その厚み
方向の内部に内面に反応部が臨む体液通路が形成されて
おり、かつ、この体液通路に連通するとともに上記穿刺
体の尖端が通過可能な貫通穴が形成された構成を備えて
いる。In a preferred embodiment, the sensor of the wearing body has a plate shape extending along the skin contact surface as a whole, and a reaction portion faces the inner surface inside the thickness direction. A body fluid passage is formed, and a configuration is provided in which a through hole communicating with the body fluid passage and through which the tip of the puncture body can pass is formed.
【００１５】このように構成によれば、穿刺体が通過す
る貫通穴とセンサ内の体液通路が連通しているので、皮
膚につけた傷から出液される血液が直接的に貫通穴に入
り込み、引き続いて反応部が臨む体液通路に充満させら
れる。したがって、皮膚の傷から反応部までの距離が著
しく短くなる。また、センサそのものが板状を呈してい
ることから体液通路の容積をも小さくすることができ
る。このようなことから、測定に必要な血液量を著しく
少なくすることができる。According to this configuration, since the through-hole through which the puncture body passes and the bodily fluid passage in the sensor communicate with each other, blood discharged from a wound on the skin directly enters the through-hole, Subsequently, the body fluid passage facing the reaction section is filled. Therefore, the distance from the wound on the skin to the reaction part is significantly reduced. In addition, since the sensor itself has a plate shape, the volume of the body fluid passage can be reduced. For this reason, the blood volume required for measurement can be significantly reduced.
【００１６】好ましい実施の形態においてはさらに、上
記装着体におけるセンサは、作用極と対極とが上面に形
成されたベース板と、上記作用極と対極のそれぞれの一
部を臨ませて溝を形成するように上記ベース板上に重ね
合わされたスペーサと、上記溝の一部または全部に反応
試薬層を形成した反応部と、上記スペーサに重ね合わさ
れたカバー板とを備えて構成されており、上記溝とカバ
ー板とで囲まれる空間が体液通路を形成しているととも
に、上記作用極および上記対極とそれぞれ導通して本体
の端子と接触させられる端子部が上記ベース板の上面適
部に配置されている。In a preferred embodiment, the sensor in the mounting body further includes a base plate having a working electrode and a counter electrode formed on an upper surface, and a groove formed by facing a part of each of the working electrode and the counter electrode. A spacer overlapped on the base plate, a reaction portion having a reactive reagent layer formed on a part or all of the groove, and a cover plate overlapped with the spacer. A space surrounded by the groove and the cover plate forms a bodily fluid passage, and a terminal portion that is in electrical communication with the working electrode and the counter electrode and is brought into contact with a terminal of the main body is disposed at a suitable upper surface of the base plate. ing.
【００１７】また、他の好ましい実施の形態において
は、上記装着体におけるセンサは、作用極が上面に形成
されたベース板と、上記作用極の一部を臨ませて溝を形
成するように上記ベース板上に重ね合わされたスペーサ
と、上記スペーサに重ね合わされ、下面に上記溝に臨む
対極が形成されたカバー板と、上記作用極に接触するよ
うに上記溝に第１の試薬層を形成した第１の反応部と、
上記対極に接触するように上記カバー板の下面に第２の
試薬層を形成した第２の反応部とを備えて形成されてお
り、上記溝とカバー板とで囲まれる空間が体液通路を形
成している一方、上記作用極と導通して本体の端子と接
触させられる第１の端子部が上記ベース板の上面適部に
配置されているとともに、上記対極と導通して本体の端
子と接触させられる第２の端子部が上記カバー板の上面
に配置されている。Further, in another preferred embodiment, the sensor in the mounting body has a base plate having a working electrode formed on an upper surface and a groove formed so as to face a part of the working electrode. A spacer superimposed on the base plate, a cover plate superimposed on the spacer and having a counter electrode facing the groove on the lower surface, and a first reagent layer formed in the groove so as to contact the working electrode. A first reaction section;
A second reaction portion having a second reagent layer formed on the lower surface of the cover plate so as to be in contact with the counter electrode; and a space surrounded by the groove and the cover plate forms a body fluid passage. On the other hand, the first terminal portion, which is electrically connected to the working electrode and is brought into contact with the terminal of the main body, is disposed at an appropriate portion on the upper surface of the base plate, and is electrically connected to the counter electrode to be in contact with the terminal of the main body. A second terminal portion to be operated is arranged on the upper surface of the cover plate.
【００１８】このように構成すれば、ベース板にスクリ
ーン印刷を施す等によって作用電極あるいは対極を容易
に形成することができるとともに、板状部品を積層する
という簡便な手法により、厚み方向の内部に体液通路が
適正に形成された板状センサを簡便に作製することがで
きる。According to this structure, the working electrode or the counter electrode can be easily formed by, for example, screen printing on the base plate, and the inside in the thickness direction can be easily formed by laminating the plate-like parts. A plate-like sensor in which a bodily fluid passage is appropriately formed can be easily manufactured.
【００１９】なお、本願発明の体液測定装置を血糖値測
定用に構成する場合、センサの反応部に配置する反応試
薬としては、たとえば、酸化酵素であるグルコースオキ
シターゼおよびメディエータとしてのフェリシアン化カ
リウムを含むものが採用される。When the body fluid measuring device of the present invention is configured for measuring a blood glucose level, the reaction reagent disposed in the reaction section of the sensor includes, for example, glucose oxidase as an oxidase and potassium ferricyanide as a mediator. Is adopted.
【００２０】上記反応部が血液によって溶解されると、
数１に示される酵素反応が開始される結果、反応層に共
存させているフェリシアン化カリウムが還元され、還元
型の電子伝達体であるフェロシアン化カリウムが蓄積さ
れる。その量は、基質濃度、すなわち血液中のグルコー
ス濃度に比例する。一定時間蓄積された還元型の電子伝
達体は、数２で示される電気化学反応により、酸化され
る。測定装置本体内の電子回路は、このとき測定される
陽極電流から、グルコース濃度（血糖値）を演算・決定
し、上述したように、本体表面に配置された表示器に表
示する。When the reaction part is dissolved by blood,
As a result of the start of the enzyme reaction shown in Equation 1, potassium ferricyanide coexisting in the reaction layer is reduced, and potassium ferrocyanide, which is a reduced electron carrier, is accumulated. The amount is proportional to the substrate concentration, ie the glucose concentration in the blood. The reduced-type electron carriers accumulated for a certain period of time are oxidized by the electrochemical reaction shown in Expression 2. The electronic circuit in the measuring device main body calculates and determines the glucose concentration (blood glucose level) from the anode current measured at this time, and displays it on the display device arranged on the main body surface as described above.
【００２１】[0021]
【数１】 (Equation 1)
【００２２】[0022]
【数２】 (Equation 2)
【００２３】このように、本願発明に係る体液測定装置
によれば、使い捨て用として提供される装着体を本体に
装着した上で、この装着体の皮膚当接面を患者の指先や
耳たぶに押し当てた状態を保持しつつ、あたかも従来の
ランセットを扱うようにして穿刺体を突出させるという
操作をするだけで、それ以上の操作、あるいは動作を要
することなく、血糖値等の体液測定を適正に行うことが
できる。また、測定に必要な検体量が少なくてすむの
で、患者の負担が軽減される。As described above, according to the body fluid measuring device of the present invention, after the mounting body provided for disposable use is mounted on the main body, the skin contact surface of the mounting body is pressed against the fingertip or the earlobe of the patient. While maintaining the applied state, just perform the operation of protruding the puncture body as if handling a conventional lancet, without any further operation or operation, properly measure the body fluid such as blood glucose level It can be carried out. In addition, since the amount of the sample required for the measurement is small, the burden on the patient is reduced.
【００２４】本願発明のその他の特徴および利点は、図
面を参照して以下に行う詳細な説明から、明らかとなろ
う。[0024] Other features and advantages of the present invention will become apparent from the following detailed description, taken in conjunction with the drawings.
【００２５】[0025]
【発明の実施の形態】以下、本願発明の好ましい実施の
形態を図面を参照しつつ、説明する。図１は、本願発明
に係る体液測定装置の全体外観図、図２は、穿刺体が退
避した状態における装着体の詳細を示す拡大縦断面図で
あり図４のII−II線に沿う断面に相当する図、図３は、
穿刺体が進出した状態における装着体の詳細を示す拡大
縦断面図、図４は、装着体の底面図、図５は、センサを
外した状態での装着体の底面図である。DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Preferred embodiments of the present invention will be described below with reference to the drawings. FIG. 1 is an overall external view of a body fluid measuring device according to the present invention, and FIG. 2 is an enlarged vertical sectional view showing details of a mounted body in a state where a puncture body is retracted, and is a cross-sectional view taken along line II-II of FIG. The corresponding figure, FIG.
FIG. 4 is an enlarged vertical sectional view showing details of the mounted body in a state where the puncture body has advanced, FIG. 4 is a bottom view of the mounted body, and FIG. 5 is a bottom view of the mounted body with the sensor removed.
【００２６】図１ないし図３に示されるように、本願発
明に係る体液測定装置10は、本体20と装着体30とを組み
合わせて使用される。本体20は、その上面にスイッチボ
タン類、ＬＣＤ表示器22などが配置されている。この本
体20の前部には筒状部21が延出形成されており、その先
端部には、後に詳しく説明するキャップ状の装着体30が
装着されている。また、この本体20の内部には、装着体
30が備える穿刺体31を前進駆動するための駆動機構（2
3，32）、および、マイクロコンピュータ等の回路等が
内蔵される。図１において符号23は、上記駆動機構の一
部を構成し、使用者が手動によって押圧するための押圧
部を示している。As shown in FIGS. 1 to 3, the body fluid measuring device 10 according to the present invention is used by combining a main body 20 and a mounting body 30. The main body 20 has switch buttons, an LCD display 22, and the like disposed on an upper surface thereof. A cylindrical portion 21 is formed to extend from the front of the main body 20, and a cap-shaped mounting body 30, which will be described in detail later, is mounted at the distal end. In addition, the body
A drive mechanism (2) for driving the puncture body 31 of the
3, 32) and a circuit such as a microcomputer. In FIG. 1, reference numeral 23 denotes a pressing portion which constitutes a part of the driving mechanism and is manually pressed by a user.
【００２７】図２ないし図５に装着体30の一例の詳細を
示す。この装着体30は、円筒部34と、この円筒部34の先
端を塞ぐように位置する底壁部35とを備える大略キャッ
プ状をしており、その主要部分は樹脂成形によって作製
される。円筒部34の内径は、本体20の前部筒状部24の外
径と対応させられており、この前部筒状部24に被せるよ
うにして簡便に装着することができる。底壁部35の外面
は、使用者の皮膚に当接する皮膚当接面35ａとして機能
させられる。FIGS. 2 to 5 show details of an example of the mounting body 30. FIG. The mounting body 30 has a substantially cap shape including a cylindrical portion 34 and a bottom wall portion 35 positioned so as to close the tip of the cylindrical portion 34, and a main portion thereof is formed by resin molding. The inner diameter of the cylindrical portion 34 corresponds to the outer diameter of the front tubular portion 24 of the main body 20, and can be easily mounted so as to cover the front tubular portion 24. The outer surface of the bottom wall 35 functions as a skin contact surface 35a that contacts the skin of the user.
【００２８】このキャップ状の装着体30の底壁部35に
は、穿刺体31と、バイオセンサ36とが一体に組み込まれ
る。底壁部35には、円筒壁35ｂと底壁35ｃとを有する円
筒状の陥没部35Ａがこの装着体30の中心位置に形成さ
れ、この陥没部35Ａの底壁35ｃには、中心孔35ｄが開け
られている。The puncture body 31 and the biosensor 36 are integrated into the bottom wall 35 of the cap-shaped mounting body 30. A cylindrical depression 35A having a cylindrical wall 35b and a bottom wall 35c is formed in the bottom wall 35 at the center of the mounting body 30, and a central hole 35d is formed in the bottom wall 35c of the depression 35A. It is open.
【００２９】一方、穿刺体31は、上記中心孔35ｄにスラ
イド可能に嵌合するガイド軸部31ａとこのガイド軸部31
ａの一端に一体形成されたフランジ部31ｂとを有する樹
脂製のガイド体31Ａに金属製の穿刺針31ｃを一体にイン
サートした形態をもっており、フランジ部31ｂと後述す
る板状バイオセンサ36の上面との間に介装された弾性体
37により、常時図２に示す退避位置、すなわち、フラン
ジ部31ｂが陥没部35Ａの底壁35ｃに当接する位置に向け
て付勢されている。この退避位置において、ガイド軸部
31ａの後端は底壁35ｃの内側に突出した状態となり、穿
刺針31ｃは、後述する板状バイオセンサ36の裏側に退避
した状態となる。上記のように穿刺体31を退避位置に向
けて付勢する弾性体37の態様としては、図２および図３
に示されるように金属あるいは樹脂でできた圧縮コイル
バネを用いるほか、発泡ウレタン等の形態とすることが
できる。このように弾性体37を発泡ウレタンの形態と
し、穿刺体31が退避位置をとるとき穿刺針31ｃがこの発
泡ウレタンの内部に埋没するようにしておくと、この穿
刺針が外物に触れる機会を少なくすることができるの
で、衛生的である。また、上記弾性体37は、樹脂製のガ
イド体31Ａと一体成形された板状バネの形態とすること
ができる。On the other hand, the puncture body 31 has a guide shaft portion 31a which is slidably fitted in the center hole 35d and a guide shaft portion 31.
a has a form in which a metal puncture needle 31c is integrally inserted into a resin guide body 31A having a flange portion 31b integrally formed at one end of the flange portion 31b and the upper surface of a plate-shaped biosensor 36 described later. Elastic body interposed between
37, it is constantly urged toward the retracted position shown in FIG. 2, that is, the position where the flange portion 31b comes into contact with the bottom wall 35c of the depression 35A. In this retracted position, the guide shaft portion
The rear end of 31a is in a state of protruding inside the bottom wall 35c, and the puncture needle 31c is in a state of being retracted to the back side of a plate-shaped biosensor 36 described later. FIGS. 2 and 3 show examples of the elastic body 37 for urging the puncture body 31 toward the retracted position as described above.
In addition to using a compression coil spring made of metal or resin as shown in FIG. If the elastic body 37 is formed in the form of urethane foam and the puncture needle 31c is buried inside the urethane foam when the puncture body 31 is in the retracted position, there is an opportunity for the puncture needle to touch an external object. It is hygienic because it can be reduced. Further, the elastic body 37 may be in the form of a plate spring integrally formed with the guide body 31A made of resin.
【００３０】装着体30の底壁部35にはまた、上記穿刺体
31が収容された陥没部35Ａを覆うようにして、板状バイ
オセンサ36が貼着される。このバイオセンサ36は、図６
ないし図８に示したように穿刺体31の穿刺針31ｃが通過
しうる貫通穴36ａと、この貫通穴36ａと連通して厚みの
なかを底壁部35と平行に延びる体液通路35ｂを備え、こ
の体液通路35ｂの内壁に反応部36ｋが形成された構成を
備えている。The puncture body is also provided on the bottom wall 35 of the mounting body 30.
The plate-shaped biosensor 36 is adhered so as to cover the depression 35A in which 31 is accommodated. This biosensor 36 is shown in FIG.
As shown in FIG. 8, a puncture needle 31c of the puncture body 31 is provided with a through hole 36a through which the puncture needle 31 can pass, and a bodily fluid passage 35b communicating with the through hole 36a and extending in a thickness parallel to the bottom wall 35. A reaction portion 36k is formed on the inner wall of the bodily fluid passage 35b.
【００３１】より具体的には、このバイオセンサ36は、
上面に作用極36ｃおよび対極36ｄが膜形成された絶縁ベ
ース板36Ａと、作用極36ｃおよび対極36ｄの一部を露出
させる溝36ｅを形成するように絶縁ベース板36Ａ上に積
層された板状スペーサ36Ｂ，36Ｂと、この板状スペーサ
36Ｂ，36Ｂにさらに積層された板状カバー36Ｃとを備え
ている。以下、この板状バイオセンサ36の作製工程を説
明する。More specifically, this biosensor 36
An insulating base plate 36A having a working electrode 36c and a counter electrode 36d formed on the upper surface thereof, and a plate-like spacer laminated on the insulating base plate 36A so as to form a groove 36e exposing a part of the working electrode 36c and the counter electrode 36d. 36B, 36B and this plate-shaped spacer
36B, and a plate-like cover 36C further laminated on 36B. Hereinafter, a manufacturing process of the plate-shaped biosensor 36 will be described.
【００３２】図９に示すように、たとえば０．２ｍｍの
厚みをもつ樹脂製絶縁シートからなる平面視長矩形状の
ベース板36Ａが準備される。このベース板36Ａには、あ
らかじめたとえば１．５ｍｍ径の貫通穴361aが形成され
ている。このベース板36Ａの上面には、グラファイトイ
ンクを用いたスクリーン印刷の手法により、作用極36ｃ
と対極36ｄとが膜状に形成される。作用極36ｃは、端子
部となるべき端部領域36ｆ（作用極36ｃに斜線のみを施
した領域）から細状の突出部36ｇが延出形成された平面
形態をもち、一方、対極36ｄは、端子部となるべき端部
領域36ｈ（対極36ｄに斜線のみを施した領域）から上記
作用極36ｃ側の突出部36ｇを両側から挟むように二股状
に延びる突出部36ｉ，36ｉをもつ平面形態をもってい
る。貫通穴361aは、対極36ｄの一方の突出部36ｉと近接
して位置している。なお、上記作用極36ｃおよび対極36
ｄは、金や白金などの貴金属を蒸着するとともにエッチ
ング処理して所定のパターンを作ることによって形成す
ることもできる。As shown in FIG. 9, a base plate 36A having a rectangular shape in plan view and made of a resin insulating sheet having a thickness of, for example, 0.2 mm is prepared. A through hole 361a having a diameter of, for example, 1.5 mm is formed in the base plate 36A in advance. The working electrode 36c is formed on the upper surface of the base plate 36A by screen printing using graphite ink.
And the counter electrode 36d are formed in a film shape. The working electrode 36c has a planar shape in which a thin protruding portion 36g extends from an end region 36f to be a terminal portion (a region in which only the working electrode 36c is hatched). It has a planar form having protrusions 36i, 36i extending in a bifurcated manner so as to sandwich the protrusion 36g on the working electrode 36c side from both sides from an end region 36h to be a terminal portion (a region where only the counter electrode 36d is hatched). I have. The through hole 361a is located close to one of the protrusions 36i of the counter electrode 36d. The working electrode 36c and the counter electrode 36
d can also be formed by depositing a noble metal such as gold or platinum and etching it to form a predetermined pattern.
【００３３】次に、作用極36ｃおよび対極36ｄの各突出
部36ｇ，36ｉ，36ｉが縦方向に並ぶ帯状領域と、作用極
36ｃおよび対極36ｄの各端部領域36ｆ，36ｈを残してレ
ジスト層36ｊ（実線と一点鎖線で斜線を施した領域）を
印刷形成する。Next, a strip-shaped region in which the projecting portions 36g, 36i, 36i of the working electrode 36c and the counter electrode 36d are arranged in the vertical direction,
A resist layer 36j (a region shaded by a solid line and an alternate long and short dash line) is formed by printing, leaving the end regions 36f and 36h of the counter electrode 36c and the counter electrode 36d.
【００３４】続いて、上記レジスト層36ｊに重ねるよう
にして、レジスト層36ｊと同等の平面形状を有するスペ
ーサ板36Ｂ，36Ｂを配置する。このスペーサ板36Ｂとし
ては、たとえば厚み０．２ｍｍの樹脂製の板が採用さ
れ、表裏面に粘着剤層を設けた両面テープ態様のものが
使用される。これにより、スペーサ板36Ｂ，36Ｂで挟ま
れる凹溝36ｅが形成され（図８参照）、かつこの凹溝36
ｅの底部の帯状の領域に上記作用極36ｃと対極36ｄの各
突出部36ｇ，36ｉ，36ｉが並んで露出する格好となる。
なお、上記凹溝36ｅの幅は、たとえば１．５ｍｍ、長さ
はたとえば３ｍｍに設定される。Subsequently, spacer plates 36B, 36B having the same planar shape as the resist layer 36j are arranged so as to overlap the resist layer 36j. As the spacer plate 36B, for example, a resin plate having a thickness of 0.2 mm is adopted, and a double-sided tape type having an adhesive layer on the front and back surfaces is used. Thus, a concave groove 36e sandwiched between the spacer plates 36B, 36B is formed (see FIG. 8), and the concave groove 36e is formed.
The projecting portions 36g, 36i, 36i of the working electrode 36c and the counter electrode 36d are exposed side by side in the strip-shaped region at the bottom of e.
The width of the concave groove 36e is set to, for example, 1.5 mm, and the length is set to, for example, 3 mm.
【００３５】次に、上記凹溝36ｅの底部の帯状の領域
に、図８に良く表れているような反応試薬層36ｋを形成
する。血糖値測定用のセンサとして構成する場合、この
反応試薬は、酸化酵素であるグルコースオキシターゼお
よびメディエータとしてのフェリシアン化カリウムを含
むものが採用される。反応試薬層36ｋはたとえば分注法
により形成される。Next, a reaction reagent layer 36k as well shown in FIG. 8 is formed in the band-like region at the bottom of the concave groove 36e. When configured as a sensor for measuring a blood glucose level, a reagent containing glucose oxidase, which is an oxidase, and potassium ferricyanide as a mediator is used as the reaction reagent. The reaction reagent layer 36k is formed by, for example, a dispensing method.
【００３６】次に、図９に示したように各スペーサ板36
Ｂ，36Ｂに重ねるようにして、上記ベース板36Ａの貫通
孔361aと対応する貫通孔362bを有する平面視矩形状のカ
バー板36Ｃを重ね合わせてこのバイオセンサ36が完成す
る。すなわち、図６ないし図８に表れているように、上
記ベース板36Ａとスペーサ板36Ｂ，36Ｂとで形成された
凹溝36ｅをカバー板36Ｃで塞ぐことによって縦方向に延
びる断面横長矩形状の体液通路36ｂが形成され、かつ、
この体液通路36ｂの内面に、作用極36ｃおよび対極36ｄ
に接触する試薬層36ｋ（反応部）が形成され、かつ、こ
の体液通路36ｂはこの板状バイオセンサ36の貫通穴36ａ
に連通させられることとなる。また、体液通路36ｂにお
ける上記貫通穴の位置と反対側は、開放させられてお
り、後述するように貫通穴36ａを介してこの体液通路36
ｂないし反応部36ｋに毛管現象によって体液（血液）が
導入されるのを促す。この体液通路36ｂの容積は、前述
した凹溝36ｅの幅、長さ、およびスペーサ板36Ｂ，36Ｂ
の厚み寸法から、１．５ｍｍ×３ｍｍ×０．２ｍｍ＝
０．９μｌとなるが、試薬層36ｋの固形分体積約０．２
μｌを差し引くと、この体液通路36ｂの実質容積は約
０．7 μｌというきわめて小さなものとなる。Next, as shown in FIG.
The biosensor 36 is completed by overlapping a cover plate 36C having a rectangular shape in plan view having a through hole 362b corresponding to the through hole 361a of the base plate 36A so as to overlap the base plates 36B and 36B. That is, as shown in FIGS. 6 to 8, a body fluid having a rectangular cross section extending in the vertical direction extending in the vertical direction by closing the concave groove 36e formed by the base plate 36A and the spacer plates 36B, 36B with the cover plate 36C. A passage 36b is formed, and
A working electrode 36c and a counter electrode 36d are provided on the inner surface of the body fluid passage 36b.
A reagent layer 36k (reaction portion) is formed which comes into contact with the plate-shaped biosensor 36.
Will be communicated with. The side of the bodily fluid passage 36b opposite to the position of the through hole is opened, and the bodily fluid passage 36 is inserted through the through hole 36a as described later.
It promotes the introduction of bodily fluids (blood) into the reaction part b or the reaction part 36k by capillary action. The volume of the bodily fluid passage 36b is determined by the width and length of the concave groove 36e and the spacer plates 36B, 36B.
1.5mm x 3mm x 0.2mm =
0.9 μl, but the solid content volume of the reagent layer 36k is about 0.2
Subtracting μl, the actual volume of the bodily fluid passage 36b becomes extremely small, about 0.7 μl.
【００３７】上記のように形成された板状バイオセンサ
36は、図２に良く表れているように装着体30の底壁部35
に、穿刺針31ｃの位置とバイオセンサ36の貫通穴36ａの
位置とが一致するようにして貼着される。なお、図４お
よび図５に表れているように、装着体30の底壁部35に
は、バイオセンサ36のベース板36Ａの両端部に露出する
作用極36ｃおよび対極36ｄ用の端子部36ｆ，36ｈと対応
する丸穴362c，362dが形成されている。この丸穴362c，
362dは、装着体30を本体20に装着したときに、本体20側
のコネクタピン25ａ，25ａの先端を上記端子部36ｆ，36
ｈに接触させるためのものである。装着体30の底壁部35
にはまた、バイオセンサ貼着領域を挟むようにして弓形
の開口36ｍ，36ｍが形成されている。この開口36ｍは、
装着体30の底壁部35を皮膚当接面35ａとして皮膚に当接
させた状態において、皮膚に負圧を作用させるためのも
のである。The plate-shaped biosensor formed as described above
36 is a bottom wall portion of the mounting body 30 as is clearly shown in FIG.
The biosensor 36 is attached so that the position of the puncture needle 31c and the position of the through hole 36a of the biosensor 36 match. As shown in FIGS. 4 and 5, on the bottom wall 35 of the mounting body 30, terminal portions 36f and 36f for the working electrode 36c and the counter electrode 36d exposed at both ends of the base plate 36A of the biosensor 36 are provided. Round holes 362c and 362d corresponding to 36h are formed. This round hole 362c,
When the mounting body 30 is mounted on the main body 20, the tip of the connector pins 25a on the main body 20 is connected to the terminal portions 36f, 36d.
h. Bottom wall 35 of mounting body 30
Further, arc-shaped openings 36m, 36m are formed so as to sandwich the biosensor attachment region. This opening 36m,
This is for applying a negative pressure to the skin in a state where the bottom wall portion 35 of the mounting body 30 is in contact with the skin as a skin contact surface 35a.
【００３８】一方、本体20の筒状部21には、コネクタピ
ン25ａ，25ａの先端がこの筒状部21の前面に弾性的に突
出するようにして、一対のピンコネクタ25，25が組み込
まれている。このピンコネクタ25，25は、図１０に示し
たように電子回路33に接続されている。この電子回路33
は、マイクロコンピュータなどで構成され、後述するよ
うにバイオセンサ36内で生じる酵素反応および電気化学
反応によって生じる作用電流から検量線を用いて血糖値
等の被検知物質の測定値を決定するとともに、これを本
体20の表面に配した表示器22に表示する機能をもたせて
ある。さらに、本体20には、図２および図３に示したよ
うに上記押圧部23によって押圧駆動される押圧ロッド32
がその軸線方向（図中に矢印で示した方向）に移動可能
であり、かつバネによって常時後方側に付勢されながら
組み込まれて駆動機構23，32が構成されている。なお、
駆動機構23，32としては、これに限らず、軸方向移動可
能であってしかも軸方向の中立位置に弾性復帰するよう
に押圧ロッド32を設け、この押圧ロッド32を後方に引き
絞ってラッチ保持し、ラッチ解除ボタンを押すことでこ
の押圧ロッド32を勢い良く前方発射させ、この押圧ロッ
ド32が穿刺体31のガイド軸31ａの後端を勢いよく打ちつ
け、これにともなって穿刺針31ｃが瞬間的に皮膚当接面
35ａから突出するように構成することも可能である。ま
た、図示しない吸引シリンダ機構を本体20に内蔵させる
ことにより、筒状部21の先端に負圧を作用させることが
できるようにすることもできる。また、装着体30を本体
20に装着したときにバイオセンサ36の端子部と導通接触
するべく本体20に設ける端子は、前述したように常時ピ
ンが弾性的に突出するピンコネクタの形態とするほか、
たとえば、装着体30の本体20への装着と連動して、装着
体30が装着されていないときには端子ピンが本体内に退
動しており、装着体30が装着されると端子ピンが本体か
ら突出してバイオセンサの端子部との適切な導通接触が
図られるように構成することも可能である。On the other hand, a pair of pin connectors 25, 25 are incorporated into the cylindrical portion 21 of the main body 20 such that the tips of the connector pins 25a, 25a elastically protrude from the front surface of the cylindrical portion 21. ing. These pin connectors 25, 25 are connected to an electronic circuit 33 as shown in FIG. This electronic circuit 33
Is configured with a microcomputer or the like, and determines a measured value of a substance to be detected such as a blood glucose level using a calibration curve from an action current generated by an enzyme reaction and an electrochemical reaction generated in the biosensor 36 as described below, A function of displaying this on a display 22 disposed on the surface of the main body 20 is provided. Further, as shown in FIGS. 2 and 3, the main body 20 has a pressing rod 32 which is pressed and driven by the pressing portion 23.
Are movable in the axial direction (the direction indicated by the arrow in the figure), and are incorporated while being constantly urged rearward by a spring to form drive mechanisms 23 and 32. In addition,
The drive mechanisms 23 and 32 are not limited to this, but are provided with a pressing rod 32 which is movable in the axial direction and is elastically returned to a neutral position in the axial direction. Then, by pressing the latch release button, the pressing rod 32 is vigorously fired forward, and the pressing rod 32 vigorously strikes the rear end of the guide shaft 31a of the puncture body 31, whereby the puncture needle 31c instantaneously moves. To skin contact surface
It is also possible to configure so as to protrude from 35a. In addition, by incorporating a suction cylinder mechanism (not shown) in the main body 20, a negative pressure can be applied to the tip of the tubular portion 21. Also, mount the body 30
The terminals provided on the main body 20 to be brought into conductive contact with the terminal portions of the biosensor 36 when mounted on the terminal 20 are in the form of a pin connector in which pins always elastically protrude as described above,
For example, in conjunction with the mounting of the mounting body 30 to the main body 20, when the mounting body 30 is not mounted, the terminal pins are retracted into the main body, and when the mounting body 30 is mounted, the terminal pins are moved from the main body. It is also possible to configure so as to protrude and establish appropriate conductive contact with the terminal portion of the biosensor.
【００３９】次に、上記構成を備える体液測定装置10の
使用方法ないし動作を図１ないし図４を参照しつつ説明
する。Next, the method of use and operation of the body fluid measuring device 10 having the above configuration will be described with reference to FIGS.
【００４０】装着体30は、使い捨て消耗品として提供さ
れ、体液測定装置10の使用にあたって使用者はこの装着
体30を本体20の筒状部21に装着する（図１参照）。上記
実施形態において装着体30はキャップ状をしているの
で、このような装着作業は容易に行える。装着体30が装
着されると、図２に表れているように本体側のコネクタ
ピン25ａ，25ａの先端が装着体30の体壁部の丸穴362c，
362dを介してバイオセンサ36のベース板36Ａ両端上面に
配置された電極部36ｆ，36ｈに自動的に接触する。The mounting body 30 is provided as a disposable consumable item, and the user mounts the mounting body 30 on the tubular portion 21 of the main body 20 when using the body fluid measuring device 10 (see FIG. 1). In the above embodiment, since the mounting body 30 has a cap shape, such mounting work can be easily performed. When the mounting body 30 is mounted, the distal ends of the connector pins 25a, 25a on the main body side have round holes 362c, 362c in the body wall of the mounting body 30, as shown in FIG.
The electrode portions 36f and 36h disposed on the upper surfaces of both ends of the base plate 36A of the biosensor 36 automatically contact via the 362d.
【００４１】装着体30の底壁部35の表面、すなわち皮膚
当接面35ａを患者の皮膚の適当な部位、たとえば指先や
耳たぶに押し当てた状態で、押圧部23を押下する。そう
すると、本体20の内部の押圧ロッド32の先端が穿刺体31
のガイド軸部31ａの後端部を押し、押圧ロッド32が装着
体30の陥没部35Ａの裏側に当接するまでのストロークを
もって穿刺体31を弾性体37の弾力に抗して前方に押し出
す。このとき、穿刺体31の穿刺針31ｃは、バイオセンサ
36の貫通孔36ａをとおってバイオセンサ36の下面、すな
わち、皮膚当接面35ａから所定長さ突出する（図３の状
態）。押圧部23への押圧を解除すると、押圧ロッド32は
バネの弾力によって元の位置まで復帰動し、また、穿刺
体31もまた弾性体37の弾力によって穿刺針31ｃが皮膚当
接面35ａから没入する退避位置まで復帰する（図２の状
態）。The pressing portion 23 is pressed down while the surface of the bottom wall 35 of the mounting body 30, that is, the skin contact surface 35a is pressed against an appropriate portion of the patient's skin, for example, a fingertip or an earlobe. Then, the tip of the pressing rod 32 inside the main body 20 is
The rear end of the guide shaft 31a is pushed, and the puncture body 31 is pushed forward against the elasticity of the elastic body 37 with a stroke until the pressing rod 32 comes into contact with the back side of the depression 35A of the mounting body 30. At this time, the puncture needle 31c of the puncture body 31 is
It protrudes from the lower surface of the biosensor 36, that is, the skin contact surface 35a through the through-hole 36a of the 36 for a predetermined length (the state of FIG. 3). When the pressing on the pressing portion 23 is released, the pressing rod 32 returns to the original position by the elastic force of the spring, and the puncture needle 31c of the puncture body 31 also enters the skin contact surface 35a by the elasticity of the elastic body 37. To the retreat position (state in FIG. 2).
【００４２】皮膚当接面35ａからの穿刺針31ｃの突出に
より、皮膚に適度な傷がつけられ、この傷から出液した
血液が、毛管現象により、貫通孔36ａを介してバイオセ
ンサ36内の体液通路36ｂに導入させられる。貫通孔36ａ
は穿刺針31ｃが通過する孔であるため、この貫通孔36ａ
は皮膚の傷、すなわち出液部にきわめて近接している。
そうして、前述したように、バイオセンサ36内の体液通
路36ｂの実質容積はきわめて小さいため、少量の血液で
体液通路36ｂを充満させることが可能である。したがっ
て、出液部の血液量をいちいち黙視確認するまでもな
く、皮膚当接面を皮膚に押し付けたまま上記の操作を
し、かつ皮膚当接面35ａを皮膚に押し付けた状態を所定
時間保持するだけで、測定に必要十分な血液をセンサ中
の体液通路36ｂに導入することができる。なお、前述し
たように、吸引シリンダ機構を本体に付加し、装着体30
の前面の皮膚当接面35ａの開口36ｍを介して皮膚に負圧
を作用させながら上述した操作をすると、鬱血状態の皮
膚に穿刺針穿刺針31ｃで傷を付けることができるため、
より充分な量の血液を出液させることができる。The puncture needle 31c protrudes from the skin contact surface 35a to cause an appropriate wound on the skin, and blood discharged from the wound is subjected to capillary action to cause the blood inside the biosensor 36 to pass through the through hole 36a. The fluid is introduced into the bodily fluid passage 36b. Through hole 36a
Is a hole through which the puncture needle 31c passes.
Is very close to the wound on the skin, ie the drainage.
Then, as described above, since the substantial volume of the body fluid passage 36b in the biosensor 36 is extremely small, it is possible to fill the body fluid passage 36b with a small amount of blood. Therefore, the above operation is performed while the skin contact surface is pressed against the skin, and the state in which the skin contact surface 35a is pressed against the skin is maintained for a predetermined period of time, without having to check the blood volume of the fluid discharge part each time. With only this, blood necessary and sufficient for measurement can be introduced into the body fluid passage 36b in the sensor. As described above, the suction cylinder mechanism is added to the body,
When the above operation is performed while applying a negative pressure to the skin through the opening 36m of the front skin contact surface 35a, the stabbing needle 31c can be wound on the congested skin,
A more sufficient amount of blood can be discharged.
【００４３】バイオセンサ36内の体液通路36ｂ内におい
て、反応試薬（反応部36ｋ）が血液によって溶解される
と、以下の数３に示される酵素反応が開始される結果、
反応部36ｋに共存させているフェリシアン化カリウムが
還元され、還元型の電子伝達体であるフェロシアン化カ
リウムが蓄積される。When the reaction reagent (reaction part 36k) is dissolved by the blood in the body fluid passage 36b in the biosensor 36, an enzymatic reaction represented by the following equation 3 is started.
Potassium ferricyanide coexisting in the reaction section 36k is reduced, and potassium ferrocyanide, which is a reduced electron carrier, is accumulated.
【００４４】[0044]
【数３】 (Equation 3)
【００４５】フェロシアン化カリウムの蓄積量は、基質
濃度、すなわち血液中のグルコース濃度に比例する。一
定時間蓄積された還元型の電子伝達体は、以下の数４に
示される電気化学反応により、酸化される。The accumulated amount of potassium ferrocyanide is proportional to the substrate concentration, that is, the glucose concentration in blood. The reduced electron carriers accumulated for a certain period of time are oxidized by an electrochemical reaction represented by the following equation (4).
【００４６】[0046]
【数４】 (Equation 4)
【００４７】測定装置本体内の電子回路33は、このとき
測定される作用極電流から、グルコース濃度（血糖値）
を演算・決定し、好ましくはたとえば本体表面に配置さ
れたＬＣＤ表示器２２表示する。The electronic circuit 33 in the main body of the measuring device calculates the glucose concentration (blood glucose level) from the working electrode current measured at this time.
Is calculated and determined, and is preferably displayed on, for example, an LCD display 22 arranged on the surface of the main body.
【００４８】このように、上記体液測定装置10によれ
ば、装着体30を本体20の所定部位に装着するという簡単
な前準備をした後、装着体30の前面の皮膚当接面35ａを
患者の指先や耳たぶ等に押し当てた状態を保持しつつ、
あたかも従来のランセットを扱うようにして穿刺針31ｃ
を突出させるという操作をするだけで、それ以上の操
作、あるいは動作を要することなく、血糖値等の体液測
定を適正に行うことができる。As described above, according to the body fluid measuring device 10, after simple preparation for mounting the mounting body 30 to a predetermined portion of the main body 20, the skin contact surface 35 a on the front surface of the mounting body 30 is moved to the patient. While holding it against your fingertips, earlobes, etc.
Puncture needle 31c as if handling a conventional lancet
By simply performing the operation of projecting the body fluid, it is possible to appropriately measure the body fluid such as the blood sugar level without any further operation or operation.
【００４９】図１１ないし図１３は、バイオセンサ36の
他の構造例を示す。このバイオセンサ36は、ベース板36
Ａと、スペーサ板36Ｂ，36Ｂと、カバー板36Ｃとを備え
る点では前述のバイオセンサ36と同様であるが、ベース
板36Ａには作用極36ｃのみが形成され、カバー板36Ｃと
して導電性金属を用いることにより、このカバー板36Ｃ
の内面を対極36ｄとして機能させている。より具体的に
は、ベース板36Ａには、図１１に示すようなパターンの
作用極36ｃが形成される。そして、図１２および図１３
に示すように、この作用極36ｃの内方の一部を露出させ
るようにして、所定の間隔をあけて２枚のスペーサ板36
Ｂ，36Ｂが重ねられる。これにより、作用極36ｃの一部
が底面に露出する凹溝36ｅが形成される。作用極36ｃの
外方部は露出させられ、コネクタピン25ａ，25ａと接触
する電極部36ｆとして機能する。凹溝36ｅの幅、長さ、
深さは、それぞれ、前述の実施形態のものと同等に設定
され、この凹溝36ｅとカバー体36Ｃとにより、体液通路
36ｂが形成される。凹溝36ｅの底部には、反応試薬が塗
布された反応部36ｋが形成される。このセンサ36を血糖
値測定用に構成する場合、反応試薬として、前述したの
と同様のものを用いることができる。カバー体36Ｃの上
面適部は、コネクタピン25ａと接触する電極部36ｈとし
て機能させられる。このバイオセンサ36においても、図
１１に良く表れているように穿刺針31ｃが通過する貫通
孔36ａが上記体液通路36ｂに隣接して設けられている点
もまた、前述の実施形態と同様である。そして、このバ
イオセンサ36は、前述の実施形態と同様にして、問題な
く装着体30の底壁部35に貼着して使用することができ
る。11 to 13 show other structural examples of the biosensor 36. FIG. This biosensor 36 includes a base plate 36
A, spacer plates 36B, 36B, and a cover plate 36C are similar to the above-described biosensor 36, except that only a working electrode 36c is formed on the base plate 36A, and a conductive metal is used as the cover plate 36C. By using this cover plate 36C
Is made to function as a counter electrode 36d. More specifically, a working electrode 36c having a pattern as shown in FIG. 11 is formed on the base plate 36A. 12 and 13
As shown in the figure, two spacer plates 36 are provided at a predetermined interval so as to expose a part of the inner side of the working electrode 36c.
B and 36B are superimposed. Thereby, a concave groove 36e in which a part of the working electrode 36c is exposed on the bottom surface is formed. The outer part of the working electrode 36c is exposed and functions as an electrode part 36f that comes into contact with the connector pins 25a, 25a. The width and length of the concave groove 36e,
The depth is set to be the same as that of the above-described embodiment, and the body fluid passage is formed by the concave groove 36e and the cover body 36C.
36b is formed. At the bottom of the concave groove 36e, a reaction part 36k coated with a reaction reagent is formed. When the sensor 36 is configured for measuring a blood sugar level, the same reagent as described above can be used as the reaction reagent. An appropriate upper surface of the cover 36C functions as an electrode 36h that comes into contact with the connector pin 25a. Also in this biosensor 36, as well shown in FIG. 11, the point that a through hole 36a through which the puncture needle 31c passes is provided adjacent to the bodily fluid passage 36b is the same as in the above-described embodiment. . Then, this biosensor 36 can be used by sticking it to the bottom wall 35 of the mounting body 30 without any problem in the same manner as in the above-described embodiment.
【００５０】なお、図１１ないし図１３の構造のバイオ
センサ36において、図１４に示したようにベース板36Ａ
に形成する作用極36ｃに接触するようにしてフェリシア
ン化カリウムを含む反応試薬層361k（第１反応部）を形
成する一方、カバー体36Ｃの内面に酸化酵素であるグル
コースオキシターゼおよびメディエータとしてのフェリ
シアン化カリウムを含む反応試薬層362k（第２反応部）
を形成することによって反応部36ｋを形成する態様とす
ることも可能である。このようにすれば、酵素反応およ
び電気化学反応を介して作用電流を検出するこの種のバ
イオセンサ36において、アスコルビン酸の影響を除去し
たより正確な測定が可能となる。In the biosensor 36 having the structure shown in FIGS. 11 to 13, as shown in FIG.
A reaction reagent layer 361k (first reaction portion) containing potassium ferricyanide is formed so as to come into contact with the working electrode 36c formed on the inner surface of the cover 36C, while glucose oxidase as an oxidase and potassium ferricyanide as a mediator are formed on the inner surface of the cover 36C. Reacting reagent layer containing 362k (second reaction part)
It is also possible to adopt a mode in which the reaction section 36k is formed by forming In this manner, in this type of biosensor 36 that detects an action current through an enzymatic reaction and an electrochemical reaction, more accurate measurement without the influence of ascorbic acid can be performed.
【００５１】もちろん、この発明の範囲は上述した実施
形態に限定されることはない。実施形態では、血糖値を
測定するためのものとして説明されているが、測定対象
は血糖値に限定されない。また、装着体の具体的形状お
よびバイオセンサの具体的構造は、種々変更可能であ
る。本願発明の最も重要なポイントは、本体に装着して
使用される好ましくは使い捨ての装着体に穿刺体とバイ
オセンサとが一体的に組み込まれている点である。Of course, the scope of the present invention is not limited to the above embodiment. In the embodiment, the description is made for measuring the blood glucose level, but the measurement target is not limited to the blood glucose level. Further, the specific shape of the mounting body and the specific structure of the biosensor can be variously changed. The most important point of the present invention is that the puncture body and the biosensor are integrated into a preferably disposable mounting body used by being mounted on the main body.
【図１】本願発明に係る体液測定装置の全体外観図であ
る。FIG. 1 is an overall external view of a body fluid measurement device according to the present invention.
【図２】穿刺体が退避した状態における装着体の詳細を
示す拡大縦断面図であり、図４のII−II線に沿う断面に
相当する図である。FIG. 2 is an enlarged vertical sectional view showing details of a mounting body in a state where a puncture body is retracted, and is a view corresponding to a cross section taken along line II-II of FIG.
【図３】穿刺体が進出した状態における装着体の詳細を
示す拡大縦断面図である。FIG. 3 is an enlarged vertical sectional view showing details of a mounting body in a state where a puncture body has advanced.
【図４】装着体の底面図である。FIG. 4 is a bottom view of the mounting body.
【図５】バイオセンサを外した状態での装着体の底面図
である。FIG. 5 is a bottom view of the mounting body with the biosensor removed.
【図６】バイオセンサの平面図である。FIG. 6 is a plan view of a biosensor.
【図７】図６のVII −VII 線に沿う断面図である。FIG. 7 is a sectional view taken along line VII-VII in FIG. 6;
【図８】図７における一点鎖線で囲まれた領域の拡大図
である。FIG. 8 is an enlarged view of a region surrounded by a chain line in FIG. 7;
【図９】バイオセンサの分解斜視図である。FIG. 9 is an exploded perspective view of the biosensor.
【図１０】電気的な構成を説明するための概略構成図で
ある。FIG. 10 is a schematic configuration diagram for describing an electrical configuration.
【図１１】バイオセンサの変形例を示す平面図である。FIG. 11 is a plan view showing a modification of the biosensor.
【図１２】図１１のXII −XII 線に沿う断面図である。FIG. 12 is a sectional view taken along the line XII-XII of FIG. 11;
【図１３】図１２の一点鎖線Ｂで囲まれた領域の拡大図
である。FIG. 13 is an enlarged view of a region surrounded by a dashed line B in FIG.
【図１４】変形例のバイオセンサにおける反応部の変形
例を示す要部を拡大した断面図である。FIG. 14 is an enlarged cross-sectional view of a main part showing a modification of the reaction unit in the biosensor of the modification.
１０ 体液測定装置 ２０ 本体 ２３ 押圧部（駆動機構を構成する） ２５ａ コネクタピン（本体の端子としての） ３０ 装着体 ３１ 穿刺体 ３２ 押圧ロッド（駆動機構を構成する） ３３ 電子回路 ３５ａ 皮膚当接面 ３６ バイオセンサ ３６Ａ ベース板（バイオセンサを構成する） ３６Ｂ スペーサ（バイオセンサを構成する） ３６Ｃ カバー板（バイオセンサを構成する） ３６ａ 貫通孔（バイオセンサの） ３６ｂ 体液流路（バイオセンサの） ３６ｃ 作用極（バイオセンサの） ３６ｄ 対極（バイオセンサの） ３６ｅ 溝（バイオセンサの） ３６ｋ 反応部（バイオセンサの反応試薬層） ３６ｆ，３６ｈ 端子部（センサの電極としての） ３６１ｋ 第１反応部（変形例のバイオセンサの反応試
薬層） ３６２ｋ 第２反応部（変形例のバイオセンサの反応試
薬層） ３７ コイルバネ（弾性体としての）DESCRIPTION OF SYMBOLS 10 Body fluid measuring device 20 Main body 23 Pressing part (constituting a driving mechanism) 25a Connector pin (as a terminal of the main body) 30 Mounting body 31 Puncturing body 32 Pressing rod (constituting a driving mechanism) 33 Electronic circuit 35a Skin contact surface 36 Biosensor 36A Base plate (constituting biosensor) 36B Spacer (constituting biosensor) 36C Cover plate (constituting biosensor) 36a Through hole (for biosensor) 36b Body fluid flow path (for biosensor) 36c Working electrode (of biosensor) 36d Counter electrode (of biosensor) 36e Groove (of biosensor) 36k Reaction part (reaction reagent layer of biosensor) 36f, 36h Terminal part (as electrode of sensor) 361k First reaction part ( (Reaction reagent layer of biosensor of modified example) 362k Second reaction unit (biosensor of modified example) Coil spring (as elastic body)
Claims (11)
着体とを備えた体液測定装置であって、 上記装着体は、皮膚当接面と、この皮膚当接面に沿うよ
うに配置されたセンサと、尖端が皮膚当接面から突出す
る進出位置と尖端が皮膚当接面から没入する退避位置と
の間を移動可能であり、かつ弾性体によって退避位置側
に付勢されている穿刺体とを備えており、 上記本体は、上記装着体が装着されたときにこの装着体
が備えるセンサの各電極に接触してこれらに導通する端
子、この端子を介して得られる電気信号に基づいて測定
値を決定する電子回路、および、上記穿刺体を前進駆動
してこの穿刺体に進出位置をとらせるための駆動機構を
備えていることを特徴とする、ランセット一体型体液測
定装置。1. A body fluid measuring device comprising: a main body; and a mounting body used by being mounted on the main body, wherein the mounting body is arranged along a skin contact surface and along the skin contact surface. And the retracted position, in which the pointed tip projects from the skin contact surface, and the retracted position, in which the point is retracted from the skin contact surface, and is biased toward the retracted position by an elastic body. A puncture body, wherein the main body contacts each electrode of the sensor provided in the mounting body when the mounting body is mounted, and a terminal that conducts to the electrodes, and an electric signal obtained through the terminal. An lancet-integrated body fluid measuring device, comprising: an electronic circuit that determines a measurement value based on the puncture body; and a drive mechanism that drives the puncture body forward to cause the puncture body to assume an advanced position.
一体成形されている、請求項１に記載の体液測定装置。2. The puncture body and the elastic body in the mounting body,
The body fluid measurement device according to claim 1, wherein the body fluid measurement device is integrally formed.
に静止した状態において、この穿刺体の穿刺針が弾性体
内に退行し、保護されるように構成されている、請求項
１または２に記載の体液測定装置。3. The mounting body according to claim 1, wherein the puncture needle of the puncture body retreats into the elastic body and is protected when the puncture body is stationary at the retreat position side. 3. The body fluid measuring device according to 2.
膚に負圧を作用させるための開口が形成されている、請
求項１に記載の体液測定装置。4. The body fluid measuring device according to claim 1, wherein an opening for applying a negative pressure to the skin is formed in the skin contact surface of the wearing body.
呈している、請求項１に記載の体液測定装置。5. The body fluid measuring device according to claim 1, wherein the mounting body has a cap shape as a whole.
て上記皮膚当接面に沿うように延びる板状を呈している
とともに、その厚み方向の内部に内面に反応部が臨む体
液通路が形成されており、かつ、この体液通路に連通す
るとともに上記穿刺体の尖端が通過可能な貫通穴が形成
されている、請求項１ないし５のいずれかに記載の体液
測定装置。6. The sensor in the wearing body has a plate shape extending along the skin contact surface as a whole, and a body fluid passage in which a reaction part faces an inner surface in a thickness direction thereof. The body fluid measuring device according to any one of claims 1 to 5, wherein the body fluid measuring device is provided with a through hole communicating with the body fluid passage and through which the tip of the puncture body can pass.
対極とが上面に形成されたベース板と、上記作用極と対
極のそれぞれの一部を臨ませて溝を形成するように上記
ベース板上に重ね合わされたスペーサと、上記溝の一部
または全部に反応試薬層を形成した反応部と、上記スペ
ーサに重ね合わされたカバー板とを備えて構成されてお
り、上記溝とカバー板とで囲まれる空間が体液通路を形
成しているとともに、上記作用極および上記対極とそれ
ぞれ導通して本体の端子と接触させられる端子部が上記
ベース板の上面適部に配置されている、請求項６に記載
の体液測定装置。7. A sensor in the mounting body, wherein the base plate has a working electrode and a counter electrode formed on an upper surface, and the base plate has a groove formed so as to face a part of each of the working electrode and the counter electrode. It is configured to include a spacer superimposed thereon, a reaction portion in which a reactive reagent layer is formed on a part or all of the groove, and a cover plate superimposed on the spacer, and the groove and the cover plate 7. The enclosed space forms a bodily fluid passage, and a terminal portion that is in electrical communication with the working electrode and the counter electrode and is brought into contact with a terminal of the main body is disposed at an appropriate upper surface of the base plate. The body fluid measuring device according to claim 1.
上面に形成されたベース板と、上記作用極の一部を臨ま
せて溝を形成するように上記ベース板上に重ね合わされ
たスペーサと、上記スペーサに重ね合わされ、下面に上
記溝に臨む対極が形成されたカバー板と、上記作用極に
接触するように上記溝に第１の試薬層を形成した第１の
反応部と、上記対極に接触するように上記カバー板の下
面に第２の試薬層を形成した第２の反応部とを備えて形
成されており、上記溝とカバー板とで囲まれる空間が体
液通路を形成している一方、上記作用極と導通して本体
の端子と接触させられる第１の端子部が上記ベース板の
上面適部に配置されているとともに、上記対極と導通し
て本体の端子と接触させられる第２の端子部が上記カバ
ー板の上面に配置されている、請求項６に記載の体液測
定装置。8. A sensor in the mounting body, comprising: a base plate having a working electrode formed on an upper surface; and a spacer superposed on the base plate so as to face a part of the working electrode to form a groove. A cover plate superposed on the spacer, the lower surface of which is provided with a counter electrode facing the groove; a first reaction portion having a first reagent layer formed in the groove so as to contact the working electrode; And a second reaction portion having a second reagent layer formed on the lower surface of the cover plate so as to contact with the cover plate. A space surrounded by the groove and the cover plate forms a body fluid passage. On the other hand, the first terminal portion that is in contact with the working electrode and is brought into contact with the terminal of the main body is disposed at an appropriate portion on the upper surface of the base plate, and is in contact with the counter electrode and is in contact with the terminal of the main body. A second terminal portion is disposed on the upper surface of the cover plate. The body fluid measurement device according to claim 6, wherein the body fluid measurement device is provided.
れ、その下面が対極として機能させられるとともに、上
面適部が第２の端子部として機能させられる、請求項８
に記載の体液測定装置。9. The cover plate is formed of a conductor plate, and a lower surface thereof functions as a counter electrode, and a suitable upper surface portion functions as a second terminal portion.
The body fluid measuring device according to claim 1.
本体から突出する進出位置と、この進出位置より後退す
る後退位置との間を移動可能であり、かつ、常時バネに
よって進出方向に付勢されている、請求項１に記載の体
液測定装置。10. The terminal of the main body is movable between an advanced position in which a tip of the terminal protrudes from the main body and a retracted position retracted from the advanced position, and is always urged in the advanced direction by a spring. The body fluid measurement device according to claim 1, wherein
の体液測定装置における、本体に装着して使用する装着
体。11. A mounting body for use in the body fluid measuring device according to any one of claims 1 to 10, which is mounted on a main body.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP16689498A JP3873093B2 (en) | 1998-06-15 | 1998-06-15 | Lancet-integrated body fluid measuring device and attached body to be used by attaching to this body fluid measuring device |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP16689498A JP3873093B2 (en) | 1998-06-15 | 1998-06-15 | Lancet-integrated body fluid measuring device and attached body to be used by attaching to this body fluid measuring device |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2006207375A Division JP4635140B2 (en) | 2006-07-31 | 2006-07-31 | Lancet-integrated body fluid measuring device and attached body to be used by attaching to this body fluid measuring device |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2000000231A true JP2000000231A (en) | 2000-01-07 |
| JP2000000231A5 JP2000000231A5 (en) | 2005-10-13 |
| JP3873093B2 JP3873093B2 (en) | 2007-01-24 |
Family
ID=15839607
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP16689498A Expired - Lifetime JP3873093B2 (en) | 1998-06-15 | 1998-06-15 | Lancet-integrated body fluid measuring device and attached body to be used by attaching to this body fluid measuring device |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP3873093B2 (en) |
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