JP2000116629A - Mounting body - Google Patents
Mounting bodyInfo
- Publication number
- JP2000116629A JP2000116629A JP10314030A JP31403098A JP2000116629A JP 2000116629 A JP2000116629 A JP 2000116629A JP 10314030 A JP10314030 A JP 10314030A JP 31403098 A JP31403098 A JP 31403098A JP 2000116629 A JP2000116629 A JP 2000116629A
- Authority
- JP
- Japan
- Prior art keywords
- body fluid
- blood
- biosensor
- hollow needle
- mounting body
- 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.)
- Pending
Links
Landscapes
- Investigating Or Analysing Biological Materials (AREA)
- Sampling And Sample Adjustment (AREA)
- Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
Abstract
Description
【０００１】[0001]
【発明の属する技術分野】本願発明は、体液に含まれる
被検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連の操作によって行うことができ
るように構成された、体液採取具一体型の体液測定装置
に関するもので、とくに該体液採取具一体型の体液測定
装置に装着して使用する装着体に関する。BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention is designed so that a test substance contained in a body fluid can be measured, and that the collection and measurement of the body fluid from the skin can be performed by a series of operations. The present invention relates to a body fluid measuring device integrated with a body fluid sampling device, and more particularly to a body mounted on a body fluid measuring device integrated with the body fluid sampling device.
【０００２】[0002]
【発明の背景】体液を採取してその体液を測定する一例
として、血中グルコース濃度（以下、「血糖値」とい
う。）の測定が挙げられる。血糖値の測定は主に糖尿病
の検査、治療において行われている。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 One example of collecting a body fluid and measuring the body fluid is measurement of blood glucose concentration (hereinafter, referred to as "blood sugar level"). The measurement of blood sugar level is mainly performed in the examination and treatment of diabetes. It is necessary to maintain the blood sugar level of a patient in a normal range for the treatment of diabetes, and the control of the blood sugar level by the patient himself is an important treatment. In particular,
In order to maintain the blood sugar level in the normal range by the patient's own injection of insulin, appropriate blood sugar level measurement by the patient himself is indispensable.
【０００３】この血糖値測定を行う場合、まず採血を行
わなければならないが、その際主にランセットという器
具を用いて採血が行われる。その操作はランセット先端
部を皮膚に当てて、バネのような弾性要素を有した穿刺
針駆動装置を作動させることにより、穿刺針をランセッ
ト先端部より突出させて皮膚を穿刺する。穿刺した皮膚
孔より揉みだしなどにより採血が行われる。この採血は
主に感覚の敏感な指先で行われるため、また、バネのよ
うな弾性要素を用いた穿刺針駆動装置を用いることによ
り、穿刺針が皮膚を穿刺する際の皮膚への衝撃が大き
く、痛みと恐怖感を伴い、患者にとって大きな負担とな
っている。[0003] When measuring the blood sugar level, blood must first be collected. At that time, blood is collected mainly using an instrument called a lancet. In this operation, the tip of the lancet is brought into contact with the skin, and a puncture needle driving device having an elastic element such as a spring is operated, whereby the puncture needle is projected from the tip of the lancet to puncture the skin. Blood is collected from the punctured skin hole by massaging. Since this blood collection is performed mainly with a sensitive fingertip, and by using a puncture needle driving device using an elastic element such as a spring, the impact on the skin when the puncture needle pierces the skin is large. With pain and fear, it is a great burden for patients.
【０００４】これを改善する手段として指先以外でも採
血を可能とするため減圧吸引機構を内蔵したランセット
が商品名マイクロレットチョイス（バイエル三共社製）
で市販されている。このランセットを用いることにより
指先ほど感覚が敏感でない腹壁や前腕、上腕部での採血
が可能となり、痛みが低減されるが、バネのような弾性
要素を用いた穿刺針駆動装置を用いることにより、穿刺
針が皮膚を穿刺する際の皮膚への衝撃があり、痛みや恐
怖感は残る。As a means for improving this, a lancet with a built-in reduced pressure suction mechanism to enable blood collection at a place other than the fingertip is available under the trade name Microlet Choice (manufactured by Bayer Sankyo).
It is commercially available at By using this lancet, blood can be collected at the abdominal wall, forearm, and upper arm where the sensation is not as sensitive as the fingertip, and pain is reduced, but by using a puncture needle driving device using an elastic element such as a spring, There is an impact on the skin when the puncture needle punctures the skin, leaving pain and fear.
【０００５】これらの穿刺採血方法に対して、特開平７
−２５５７０６には減圧手段、穿刺手段を有する気密吸
引室及び前記穿刺手段の穿刺を間接的に解除駆動させる
為の穿刺解除手段より成る簡易採血装置が開示されてい
る。この採血装置は減圧吸引により皮膚を盛り上がら
せ、所定位置に設定された穿刺手段と皮膚を接触させ、
その後穿刺手段を解除することにより採血を無痛で行え
る。これよりも単純な機構で採血できる採血器が特開平
８−１８７２３７に開示されている。[0005] These puncture blood sampling methods are disclosed in
No.-255706 discloses a simple blood sampling apparatus comprising a pressure reducing means, an airtight suction chamber having a puncturing means, and a puncturing releasing means for indirectly driving the puncturing of the puncturing means. This blood collection device raises the skin by vacuum suction, and makes the skin come into contact with the puncture means set at a predetermined position,
Thereafter, by releasing the puncture means, blood collection can be performed painlessly. A blood collecting apparatus capable of collecting blood with a simpler mechanism is disclosed in Japanese Patent Application Laid-Open No. Hei 8-187237.
【０００６】上述のように採血され、出液させた血液を
採取し、血糖値の測定が行われるが、その一例として特
公平８−２０４１２号広報に示されているような血糖値
測定装置に装着して使用される酵素電極に血液を触れさ
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。[0006] Blood collected and drained as described above is collected, and the blood sugar level is measured. As an example, a blood sugar level measuring apparatus as disclosed in Japanese Patent Publication No. 8-20412 is used. When blood is brought into contact with an enzyme electrode that is mounted and used, 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.
【０００７】しかしながら、上記した従来一般的な血糖
値測定方法においては、検体である血液を採取するため
の採血手段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、採血動作と傷か
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。ま
た、必要な血液量を適切に目分量で量ることは難しく、
測定をうまく行うために必要量以上の血液を出液させて
おいてから試験片に触れさせるため、余分な労力と血液
が無駄となることが多い。[0007] However, in the above-mentioned conventional general blood sugar level measuring method, since the blood collecting means for collecting blood, which is a specimen, and the measuring apparatus are separate bodies, the inconvenience of having to carry both is combined. Therefore, it is necessary to perform two operations, namely, a blood collection operation and an operation of bringing the blood discharged from the wound into contact with the test piece, 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 visually recognized by the individual, it is extremely difficult to promptly and appropriately contact the blood discharged from the above-mentioned wound with the test piece. In addition, it is difficult to measure the required amount of blood
Extra labor and blood are often wasted, since more blood than necessary is drained before the test strip is touched for successful measurement.
【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、採血時の痛みや恐怖感を極力解消
し、かつ、必要量の体液検体を無駄なく正確に労力をか
けずに採取することができ、体液を測定することができ
る体液採取具一体型体液測定装置に着脱可能な装着体を
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 the above circumstances, and the operation required of a patient for measurement can be simplified to further improve the usability, and the blood collection time can be improved. Removes pain and fear from the body as much as possible and removes the required amount of bodily fluid sample from the integrated bodily fluid measuring device, which can measure bodily fluids without waste and accurately collecting bodily fluids. It is an object to provide a mountable body.
【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装着体は、少
なくとも減圧吸引機構と体液測定のための電子回路を有
した装置に着脱可能な装着体であって、中空針と体液測
定用試験片を備えたことを特徴としている。好ましい実
施の形態においては前記装着体において体液測定用試験
片の体液吸引部が中空針の延長上に配置されている。A mounting body provided by the present invention is a mounting body that is detachable from a device having at least a reduced-pressure suction mechanism and an electronic circuit for measuring body fluid, and includes a hollow needle and a test piece for measuring body fluid. It is characterized by: In a preferred embodiment, the body fluid suction part of the body fluid measurement test piece is arranged on the extension of the hollow needle in the wearing body.
【００１１】装着体に用いる中空針としては外径約０．
３ｍｍ、内径約０．１８ｍｍ（ゲージ番号３０）や外径
約０．２６ｍｍ、内径約０．１３ｍｍ（ゲージ番号３
１）が示されるが、これらに限定されることはなく各種
外径、内径のものであってよい。また、中空針の材料と
しては、特に限定されるものではないが、ステンレス
鋼、クロム鋼等の金属や、ナイロン、ポリカーボネー
ト、ポリエステル、ＰＰＯ等の硬質プラスチック等が好
適に使用される。装着体の素材としてはプラスチック材
料でできているのが好ましく、医療用具の滅菌のために
行われているγ線滅菌やエチレンオキサイドガス滅菌に
耐えうる素材であれば特に限定されない。装着体の中空
針を固定し、試験片を支持する部分が設けられるが、中
空針の部分しか通気孔がなくても、それ以外に上記支持
する部分に各種形状の通気孔を設けてもよい。The hollow needle used for the mounting body has an outer diameter of about 0.1 mm.
3 mm, inner diameter about 0.18 mm (gauge number 30), outer diameter about 0.26 mm, inner diameter about 0.13 mm (gauge number 3)
Although 1) is shown, the present invention is not limited to these and may have various outer diameters and inner diameters. The material of the hollow needle is not particularly limited, but metals such as stainless steel and chromium steel, and hard plastics such as nylon, polycarbonate, polyester, and PPO are preferably used. The material of the mounting body is preferably made of a plastic material, and is not particularly limited as long as it can withstand γ-ray sterilization and ethylene oxide gas sterilization performed for sterilization of medical devices. A portion for fixing the hollow needle of the mounting body and supporting the test piece is provided, but only the portion of the hollow needle has a ventilation hole, and other than the above, the supporting portion may be provided with ventilation holes of various shapes. .
【００１２】上記装着体における体液測定用試験片は比
色定量用試験片であっても、バイオセンサであっても良
く、その配置の仕方は体液測定用試験片の体液吸引部が
中空針の延長上に配置されていればよく、試験片は中空
針の方向に対して垂直であっても水平であっても、０゜
から９０゜のある一定の角度をなしていても良く、特に
限定されない。また、体液吸引部は空間であっても、体
液中成分との反応試薬であってもよい。The test piece for measuring body fluid in the above-mentioned mounted body may be a test piece for colorimetric determination or a biosensor, and is arranged in such a manner that the body fluid suction part of the test piece for body fluid measurement has a hollow needle. The test piece may be perpendicular or horizontal to the direction of the hollow needle, or may form a certain angle from 0 ° to 90 °. Not done. The body fluid suction unit may be a space or a reagent for reacting with a component in the body fluid.
【００１３】また上記文章中、装置に着脱可能とは装着
体を少なくとも減圧吸引機構と体液測定のための電子回
路有した体液測定装置に装着して減圧吸引を行う際、装
着体と装置の接合部が減圧吸引が行える程度の気密性を
有していればよく、形状的に制限されない。そして、装
着体を装着する少なくとも減圧吸引機構と体液測定のた
めの電子回路を有した装置において、減圧吸引機構は生
体皮膚表面を吸引するための機構であり、機械的または
化学的に減圧機能を手動又は自動的に行うもの等が例示
されるが特に限定されるものではない。なお、装置には
少なくとも減圧吸引機構と体液測定のための電子回路を
有したとしたが、これ以外に測定結果等を印刷するプリ
ンタ部や測定結果を保存するためのメモリー部、音楽を
流すための機構、データを外部に出力するための機構等
を有していてもよい。In the above text, the term "removably attachable to the device" means that the attachment is attached to the body fluid measuring device having at least a reduced-pressure suction mechanism and an electronic circuit for measuring the body fluid, and the attachment is connected to the device when performing the reduced pressure suction The shape is not limited as long as the portion has airtightness enough to perform vacuum suction. Then, in a device having at least a reduced pressure suction mechanism for mounting the mounting body and an electronic circuit for measuring body fluid, the reduced pressure suction mechanism is a mechanism for suctioning the surface of the living skin, and has a mechanical or chemical decompression function. Examples of the operation are performed manually or automatically, but are not particularly limited. Although the device had at least a vacuum suction mechanism and an electronic circuit for measuring body fluid, it also had a printer section for printing measurement results, a memory section for storing measurement results, and music for streaming. And a mechanism for outputting data to the outside.
【００１４】[0014]
【発明の実施の形態】以下、本願発明の好ましい実施の
形態の一例を図面を参照しつつ、説明する。DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, an example of a preferred embodiment of the present invention will be described with reference to the drawings.
【００１５】図１は、本願発明の装着体の垂直断面図で
ある。装着体３０は試験片として例えばバイオセンサ３
６を用い、該バイオセンサ３６のベース板３６Ａを中空
針３１の延長線上で皮膚と接する側と反対側の開口部に
接する形で、中空針３１の方向に対して垂直に設置され
ている。FIG. 1 is a vertical sectional view of the mounting body of the present invention. The mounting body 30 is a test piece, for example, a biosensor 3
6, the base plate 36A of the biosensor 36 is installed perpendicularly to the direction of the hollow needle 31 so as to be in contact with the opening on the side opposite to the skin on the extension of the hollow needle 31.
【００１６】図２は本願発明の装着体の上から見た図で
ある。バイオセンサ３６の貫通孔３６２ｂは中空針の開
口部と重なるように設置されており、また貫通孔３６２
ｂはバイオセンサ３６の体液通路３６ｂにつながるよう
になっている。また、電極の端子部３６ｆ、３６ｈは体
液採取具一体化体液測定装置１０と電気的接点となって
おり、通気孔３９が開けられている。FIG. 2 is a top view of the mounting body of the present invention. The through hole 362b of the biosensor 36 is installed so as to overlap with the opening of the hollow needle.
b is connected to the body fluid passage 36b of the biosensor 36. In addition, the terminal portions 36f and 36h of the electrodes are in electrical contact with the body fluid collecting device integrated body fluid measuring device 10, and the vent hole 39 is opened.
【００１７】図３は図１、図２の装着体に示されている
バイオセンサの分解斜視図である。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。FIG. 3 is an exploded perspective view of the biosensor shown in the mounting body of FIGS. More specifically, the biosensor 36 has a working electrode 36c and a counter electrode 36d on the upper surface.
And a plate-like spacer 36B, 36B laminated on the insulating base plate 36A so as to form a groove exposing a part of the working electrode 36c and the counter electrode 36d.
A plate-like cover 36C is further provided on the plate-like spacers 36B, 36B. Below, this plate-shaped biosensor
A description will be given of 36 manufacturing steps.
【００１８】図３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. 3, for example, a base plate 36A having a rectangular shape in plan view and made of a resin insulating sheet having a thickness of 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.
【００１９】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 belt-like region in which the projecting portions 36g, 36i, 36i of the working electrode 36c and the counter electrode 36d are arranged in a 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.
【００２０】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
れる凹溝が形成され、 かつこの凹溝の底部の帯状の領
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. As a result, a concave groove sandwiched between the spacer plates 36B, 36B is formed, and each of the projecting portions 36g, 36i of the working electrode 36c and the counter electrode 36d is formed in a band-like region at the bottom of the concave groove.
36i will be exposed side by side. The width of the concave groove is set to, for example, 1.5 mm, and the length is set to, for example, 3 mm.
【００２１】次に、上記凹溝の底部の帯状の領域に、反
応試薬層を形成する。体液中グルコース濃度値用のセン
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
試薬層はたとえば分注法により形成される。Next, a reaction reagent layer is formed in a band-like region at the bottom of the groove. When configured as a sensor for a glucose concentration value in a body fluid, a reaction reagent containing glucose oxidase as an oxidase and potassium ferricyanide as a mediator is employed. The reaction reagent layer is formed by, for example, a dispensing method.
【００２２】次に、図３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。上記ベース板36Ａとスペーサ板36Ｂ，36Ｂとで形成
された凹溝をカバー板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（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、貫
通穴を介してこの体液通路36ｂないし反応部に毛管現象
によって体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、試薬層の固形分体積約
０．２μｌ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. By closing the concave groove formed by the base plate 36A and the spacer plates 36B, 36B with the cover plate 36C, a body fluid passage 36b having a rectangular cross section extending in the vertical direction is formed, and is formed on the inner surface of the body fluid passage 36b. , Working electrode 36c and counter electrode
A reagent layer (reaction part) is formed in contact with 36d, and the bodily fluid passage 36b communicates with the through hole of the plate-shaped biosensor 36. Further, the opposite side of the body fluid passage 36b from the position of the through hole is opened, thereby facilitating the introduction of the body fluid into the body fluid passage 36b or the reaction part through the through hole by capillary action. This body fluid passage 36b
The volume of the groove, the width and length of the groove described above, and the spacer plate
From the thickness dimensions of 36B and 36B, 1.5 mm x 3 mm x 0.
2 mm = 0.9 μl, but when the solid content volume of the reagent layer is subtracted from about 0.2 μl, the substantial volume of the bodily fluid passage 36 b becomes as extremely small as about 0.7 μl.
【００２３】図４は本願発明の装着体３０を装着した体
液測定装置１０の全体外観図である。体液測定装置１０
は、その上面にスイッチボタン類、表示部２０などが配
置されている。また、この体液測定装置内部には減圧吸
引機構およびマイクロコンピューター等の回路が内蔵さ
れている。図４において符合２１は使用者が手動によっ
て上記減圧吸引機構を駆動させるための押圧部を示して
いる。FIG. 4 is an overall external view of the body fluid measuring device 10 equipped with the mounting body 30 of the present invention. Body fluid measuring device 10
On the upper surface, switch buttons, a display unit 20, and the like are arranged. Also, a circuit such as a reduced-pressure suction mechanism and a microcomputer is built in the body fluid measuring device. In FIG. 4, reference numeral 21 indicates a pressing portion for manually driving the above-described vacuum suction mechanism by a user.
【００２４】次に、体液採取測定の一連の動作を図４，
図５を参照しつつ説明する。Next, a series of operations of body fluid sampling measurement will be described with reference to FIGS.
This will be described with reference to FIG.
【００２５】まず装着体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を体液測定装置１０の前部筒状部２４に装
着する（図４参照）。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５ａに表れ
ているように体液測定装置１０のコネクタピン２５ａ、
２５ａの先端が装着体３０のバイオセンサ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。体液測定装置１０に装着された装着
体の開口面を被験者の適当な部位、例えば前腕部の皮膚
３７に押し当てられる（図５ａの状態）。First, the mounting body 30 is provided as a disposable consumable. When using the body fluid measuring device 10, the user mounts the mounting body 30 on the front tubular portion 24 of the body fluid measuring device 10 (see FIG. 4). In the above embodiment, the mounting body 30
Since the is shaped like a cap, such mounting work can be easily performed. When the mounting body 30 is mounted, as shown in FIG. 5A, the connector pins 25a,
The tip of 25a automatically comes into contact with the electrode portions 36f and 36h disposed on both upper surfaces of the base plate 36A of the biosensor 36 of the mounting body 30. The opening surface of the body mounted on the body fluid measurement device 10 is pressed against an appropriate part of the subject, for example, the skin 37 on the forearm (state in FIG. 5A).
【００２６】次に図５ａの状態で体液測定装置の押圧部
２１を押下する。そうすると減圧吸引機構が駆動され、
装着体内が減圧され、皮膚３７が盛り上げられる（図５
ｂの状態）。Next, in the state shown in FIG. 5A, the pressing portion 21 of the body fluid measuring device is depressed. Then the vacuum suction mechanism is driven,
The inside of the mounted body is decompressed, and the skin 37 is raised (FIG. 5).
b state).
【００２７】さらに時間が経つと、さらに皮膚３７が盛
り上げられ、皮膚３７は中空針と接触し、受動的に穿刺
される。そして、中空針を通して皮膚３７の内部に減圧
吸引力が働き、体液が吸引される（図５ｃの状態）。After a further time, the skin 37 is further raised, and the skin 37 comes into contact with the hollow needle and is punctured passively. Then, a reduced pressure suction force acts on the inside of the skin 37 through the hollow needle, and the body fluid is sucked (the state of FIG. 5C).
【００２８】さらに吸引されると体液はバイオセサの貫
通孔に達する。達した体液は毛細管現象により体液通路
３６ｂに吸引され、体液通路を充満させる。なお、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、少量の体液で体液通路を
充満させることが可能である。その後、バイオセンサ36
内の体液通路36ｂ内において、反応試薬が体液によって
溶解されると、以下の数１に示される酵素反応が開始さ
れる結果、反応部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 further sucked, the body fluid reaches the through-hole of the biosesa. The reached bodily fluid is sucked into the bodily fluid passage 36b by capillary action, and fills the bodily fluid passage. As described above, since the substantial volume of the bodily fluid passage 36b in the biosensor 36 is extremely small, it is possible to fill the bodily fluid passage with a small amount of bodily fluid. Then the biosensor 36
When the reaction reagent is dissolved by the body fluid in the body fluid passage 36b, the enzymatic reaction represented by the following equation 1 is started, and as a result, potassium ferricyanide coexisting in the reaction part is reduced, and the reduced electron Potassium ferrocyanide, a transmitter, is accumulated.
【００２９】[0029]
【数１】 (Equation 1)
【００３０】フェロシアン化カリウムの蓄積量は、基質
濃度、すなわち体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２に
示される電気化学反応により、酸化される。The amount of potassium ferrocyanide accumulated is proportional to the substrate concentration, that is, the glucose concentration in the body fluid. The reduced electron carriers accumulated for a certain period of time are oxidized by an electrochemical reaction represented by the following equation (2).
【００３１】[0031]
【数２】 (Equation 2)
【００３２】体液測定装置内の電子回路は、このとき測
定される作用極電流から、グルコース濃度を演算・決定
し、好ましくはたとえば本体表面に配置された表示部２
０表示する。The electronic circuit in the body fluid measuring device calculates and determines the glucose concentration from the working electrode current measured at this time, and preferably, for example, the display unit 2 disposed on the surface of the main body.
0 is displayed.
【００３３】このように、上記体液測定装置10によれ
ば、装着体30を体液測定装置１０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の開口面を患者
の前腕部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減圧吸引操作をするだ
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、減圧吸引力で皮膚を盛り上げ中空針で皮膚を受動的
に穿刺することにより恐怖感や痛みが軽減され、なおか
つ穿刺採血手段に中空針を用い、中空針の延長線上に体
液測定用試験片を配置することにより微量の血液量で、
無駄なく測定できる。As described above, according to the body fluid measuring device 10, after performing simple preparation for mounting the mounting body 30 to a predetermined portion of the body fluid measuring device 10, the opening surface of the mounting body 30 is moved to the forearm of the patient. While maintaining the state of being pressed against, etc., just perform a reduced pressure suction operation as if handling a conventional lancet, and perform proper measurement of body fluid such as blood sugar level without any further operation or operation. be able to. Moreover, fear and pain are reduced by raising the skin with a reduced pressure suction force and passively puncturing the skin with a hollow needle, and using a hollow needle as a puncture blood sampling means, and a body fluid measurement test piece on an extension of the hollow needle. By placing a small amount of blood,
Measurement can be performed without waste.
【００４９】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、グルコー
ス濃度値を測定するためのものとして説明されている
が、測定対象はグルコース濃度値に限定されない。装着
体の具体的形状および体液測定用試験片の種類および具
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、体液測定装置に装着して使用される装着
体であって、前記装着体に中空針と体液測定用試験片と
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 glucose concentration value, but the measurement target is not limited to the glucose concentration value. The specific shape of the wearing body and the type and specific structure of the test piece for measuring body fluid can be variously changed. The most important point of the present invention is that the mounting body is used by being mounted on a body fluid measurement device, and the hollow needle and the test piece for measuring body fluid are integrated into the mounting body.
【図１】本願発明の装着体の垂直断面図である。FIG. 1 is a vertical sectional view of a mounting body of the present invention.
【図２】本願発明の装着体の上から見た図である。FIG. 2 is a top view of the mounting body of the present invention.
【図３】装着体に備え付けられるバイオセンサの分解斜
視図である。FIG. 3 is an exploded perspective view of a biosensor provided on the mounting body.
【図４】装着体を装着した体液採取具一体型体液測定装
置の全体外観図である。FIG. 4 is an overall external view of a body fluid sampling device-integrated body fluid measurement device with a body mounted.
【図５】体液が採取される一連の流れ図である。ａは皮
膚に当てた状態、ｂは減圧吸引により皮膚が盛り上がり
始めた状態、ｃは盛り上がった皮膚に中空針が受動的に
穿刺されて、体液が吸引されている状態を示す。FIG. 5 is a series of flow diagrams from which a bodily fluid is collected. a shows a state in which the skin has begun to swell by decompression suction, and c shows a state in which a hollow needle has been passively punctured into the swelled skin and body fluid has been sucked.
１０ 体液測定装置 ２０ 表示部 ２１ 押圧部 ２５ コネクタ ２５ａ コネクタピン（体液測定装置の端子としての） ３０ 装着体 ３１ 中空針 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） ３６ｂ 体液通路（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） ３６ｆ，３６ｈ 端子部（センサの電極としての） ３７ 皮膚 ３８ 支持体 ３９ 通気孔 Reference Signs List 10 body fluid measuring device 20 display unit 21 pressing unit 25 connector 25a connector pin (as terminal of body fluid measuring device) 30 mounted body 31 hollow needle 36 biosensor 36A base plate (constituting biosensor) 36B spacer (constituting biosensor) 36C Cover plate (constituting biosensor) 36b Body fluid passage (for biosensor) 36c Working electrode (for biosensor) 36d Counter electrode (for biosensor) 36f, 36h Terminal portion (as sensor electrode) 37 Skin 38 Support 39 vent
フロントページの続き (51)Int.Cl.7 識別記号 ＦＩ テーマコート゛(参考） Ｇ０１Ｎ 1/10 Ｖ (72)発明者 勝木 幸治 京都府京都市南区東九条西明田町57 株式 会社京都第一科学内 (72)発明者 浜本 勝美 京都府京都市南区東九条西明田町57 株式 会社京都第一科学内 Ｆターム(参考） 2G045 AA13 AA25 BB60 CA25 CB09 DA31 FB01 FB17 HA06 HA10 HA14 4C038 KK10 KL01 KM00 KY00 KY02 TA04 UG01 UG04 Continued on the front page (51) Int.Cl. 7 Identification symbol FI Theme coat II (Reference) G01N 1/10 V (72) Inventor Koji Kachi 57 Kyoto-Daiichi Kagaku Co., Ltd. 57 (72) Inventor Katsumi Hamamoto 57, Higashi-Kujo Nishida, Minami-ku, Kyoto, Kyoto Prefecture F-term (reference) 2G045 AA13 AA25 BB60 CA25 CB09 DA31 FB01 FB17 HA06 HA10 HA14 4C038 KK10 KL01 KM00 KY00 KY02 TA04 UG01 UG04
Claims (3)
めの電子回路を有した装置に着脱可能な装着体であっ
て、前記装着体が中空針と体液測定用試験片を備えたこ
とを特徴とする装着体。1. A mounting body detachable from a device having at least a reduced-pressure suction mechanism and an electronic circuit for measuring body fluid, wherein the mounting body includes a hollow needle and a test piece for measuring body fluid. Wearing body to do.
の延長上に配置されていることを特徴とする請求項１に
記載の装着体。2. The mounting body according to claim 1, wherein the body fluid suction portion of the body fluid measurement test piece is disposed on an extension of the hollow needle.
請求項１に記載の装着体。3. The wearing body according to claim 1, wherein the body fluid measurement test piece is a biosensor.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP10314030A JP2000116629A (en) | 1998-10-15 | 1998-10-15 | Mounting body |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP10314030A JP2000116629A (en) | 1998-10-15 | 1998-10-15 | Mounting body |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| JP2000116629A true JP2000116629A (en) | 2000-04-25 |
Family
ID=18048378
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP10314030A Pending JP2000116629A (en) | 1998-10-15 | 1998-10-15 | Mounting body |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP2000116629A (en) |
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