JP3789557B2 - Blood test tool and blood test measuring instrument - Google Patents

Blood test tool and blood test measuring instrument Download PDF

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JP3789557B2
JP3789557B2 JP17207296A JP17207296A JP3789557B2 JP 3789557 B2 JP3789557 B2 JP 3789557B2 JP 17207296 A JP17207296 A JP 17207296A JP 17207296 A JP17207296 A JP 17207296A JP 3789557 B2 JP3789557 B2 JP 3789557B2
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blood
blood test
test tool
concave groove
thin tube
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JPH1019888A (en
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尚貴 森川
透 大森
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Terumo Corp
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Terumo Corp
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Description

【0001】
【発明の属する技術分野】
本発明は血液中の特定成分を測定する血液検査具及び測定器に関する。
【0002】
【従来の技術】
従来の血液検査具として実公昭60−38216号が知られている。この液体分析用器具aは、図8に示すように、液体中の特定成分により反応を示す試薬層b、液体吸収層c及び被覆部材dがそれぞれ重層され、最上層の被覆部材dに小孔eが設けられてなる。そして、この液体分析用器具aは次のようにして使用される。すなわち、その被覆部材dの小孔e上に血液が塗布される。塗布された血液は、小孔eを通り液体吸収性部材c中で拡散され、やがて試薬層bに達し、該試薬層bに含まれる試薬により呈色反応を起こす。この一定時間経過後の呈色を測定器で測定することにより、血液中の特定成分を測定する。
【0003】
上述のような液体分析用器具aを用いて血液中の特定成分を測定するには、必要にして充分な血液が小孔eから液体吸収性部材cに供給されなければならない。しかしながら試料の血液は、指頭等をメスまたは針などで穿刺し、絞り出す操作をして皮膚上にごく少量を集め、さらに上述の液体分析用器具aでは、単に最上層の被覆部材dに小孔eが設けられているだけであるため、小孔eの位置確認を指先で行うから、小孔eの周りに血液を付けてしまい、指先に付いている血液をうまく小孔eに供給できなかった。また、指先上の血液が球状にならず流れて広がった場合や、血液採取を腹壁や耳朶から行う場合には、小孔eへの供給は非常に困難であった。
【0004】
このような問題を解決するために特開平3−99265が知られている。図9に示すとおり、この液体分析用器具アは、液体吸収性部材イ及び試薬層ウを片面に備えてなる器具本体エと、一端に液体の吸収口を有し、他端を前記液体吸収性部材イと接するように細管オを設けてなる。この発明により上述の問題は解決されたが、一方新たな問題を生じた。血液を、指頭等から細管オにより毛細管現象で吸収する際、細管先端を皮膚面に押しつけ細管を塞いだ場合には、必要量の血液を吸収する前に皮膚からの血液の供給が止まってしまい、測定が開始できなかったり、正確な測定ができなかった。
また、血液検査具を測定器から取り外す場合、特に病棟等で第3者の血液を測定する際、測定者が第3者の血液に触れ、B型肝炎やエイズ等の感染のおそれがあった。
【0005】
【発明が解決しようとする課題】
本発明の目的は、上述したような血液の形態、採取部位、及び採取手技によらず、簡便に血液を採取でき、また正確な測定値を得ると共に、血液検査具廃棄時の安全性をも考慮した血液検査具及び血液検査測定器を提供することにある。
【0006】
【問題を解決するための手段】
上記目的は、下記(1)〜(6)の発明により達成される。
(1) 血液中の成分と反応を示す試薬が担持された血液吸収性部材と、一端に血液吸入口を有し他端に血液排出口を有し、前記排出口側端面が前記血液吸収部材に接触する細管とを備えた血液検査具において、
前記細管の吸入口側端面に、前記吸入口と連通する凹溝Aを設けたことを特徴とする血液検査具。
(2) 前記凹溝Aの細管との接触部分の周長が前記吸入口側端面の全周の50%以下を占める上記(1)に記載の血液検査具。当該周長の下限は血液が流れれる範囲であれば特に限定しないが1%以上、好ましくは10%以上あれば良い。
【0007】
(3) 前記細管の排出口側端面に、前記排出口と連通する凹溝Bを設けたことを特徴とする上記(1)乃至(2)に記載の血液検査具。
(4) 前記凹溝Bの細管との接触部分の周長が前記吸入口側端面の全周の50%以下を占める上記(1)乃至(3)に記載の血液検査具。当該周長の下限は血液が流れれる範囲であれば特に限定しないが1%以上、好ましくは10%以上あれば良い。
(5) 血液成分と血液吸収性部材に担持された試薬との反応速度によって血液のヘマトクリット値を測定し、当該ヘマトクリット値によって血液中の成分の測定値を補正する手段を備え、上記(1)乃至(4)に記載の血液検査具により血液中の成分の測定を行う血液検査測定器。
(6) 血液検査具を触れることなく取り外すことのできる機構を備えた上記(5)に記載の血液検査測定器。
【0008】
【発明の実施の形態】
以下、本発明の血液検査具及び血液検査測定器を、添付図面に基づいて詳細に説明する。
図1は本発明の血液検査具の実施例を示す縦断面図、図2及び図3は、それぞれ図1に示す細管両端の斜視図、図4及び図5は細管両端の上面図、図6は血液検査具の使用状態を示す縦面図、図7は血液検査具と血液検査測定器との組み合わせ使用状態を示す縦断面図を示す。
図1に示す本発明の血液検査具100は、主に血液中の成分と反応を示す試薬を担持した血液吸収性部材1、血液吸入のための細管20を備えたホルダー2により構成されている。以下、各構成要素について説明する。
血液吸収性部材1は、多孔性膜を担体とし試薬を含浸したものである。多孔性膜は血液中の赤血球を濾過できる程度の孔径を有するものが望ましい。多孔性膜を使用することにより、特にオキシダーゼ反応のように大気中の酸素を基質として反応する過程を含む試薬系において、試料が試薬層上に展開後、試料受容側が試料に覆われた状態でも反対側より大気中の酸素が供給されることにより、反応を迅速に進ませることができ、試料を除去することなく発色を観察することができる。
【0009】
多孔性膜の材質としては、ポリエステル類、ポリアミド類、ポリオレフィン類、ポリスルホン類またはセルロース類等があげられが、試薬を溶解した水溶液を含浸させたり、測定時には血球を濾過するため、親水性の材料または、親水化された材質が好ましい。親水化はプラズマ処理、グロー放電、コロナ放電、紫外線照射等の物理活性化処理のほか、界面活性剤、水溶性シリコン、ヒドロキシプロピルセルロース、ポリエチレングリコール、ポリプロピレングリコール等の塗布等により行うことができる。
反応試薬として、オキシダーゼ及びペルオキシダーゼ存在下4-アミノアンチピリンと、上記の水素供与体との酸化縮合反応が知られている。
なお、血液吸収性部材1は、後述するが、ホルダー2と接着や融着等によって固着されている。
【0010】
図1に示すホルダー2は、細管20、血液吸収性部材との固着部30、測定器との嵌合部40、及びフランジ50から構成されている。各構成部は成形により一体に成形されているが、別々の部品を組み合わせて構成しても良い。
ホルダー2は所定の剛性を有する剛性材料で構成されている。材料としては、例えばアクリル樹脂、ポリスチレン、ポリプロピレン、ポリエチレン、硬質ポリ塩化ビニル、ポリカーボネート、ABS樹脂、ポリエステル、ポリフェニレンサルファイド(PPS)等があげられるが、測定時には血液を吸入、展開するため、アクリル樹脂等の親水性の高い材料、または親水化された材質が好ましい。親水化はプラズマ処理、グロー放電、コロナ放電、紫外線照射等の物理活性化処理のほか、界面活性剤、水溶性シリコン、ヒドロキシプロピルセルロース、ポリエチレングリコール、ポリプロピレングリコール等の塗布等により行うことができる。
【0011】
図2に示す細管20の血液吸入口側端21の端面22には、血液採取部位の皮膚によって塞がれ、血液の吸入を妨げられることのないように、凹溝23を形成している。図4(a)及びその線分I-I′の断面である図4(b)に示す凹溝23の細管との接触部分の周長D1は、血液の吸入開始を妨げることのない大きさでなくてはならなず、細管の半径をrとすると、D1≦2×π×r×50%が望ましい。
図6に示す凹溝23の深さPについては、皮膚の状態にもよるが、細管20を皮膚によって塞ぐことのない、0.1mm以上、好ましくは0.2mmから1mmが好ましい。凹溝23の形状は、図2及び図4の形状に限定されず、一部皮膚に触れない構造を有していればよい。他にも例えば、複数の凹溝を細管20を中心に放射状に形成したり、細管20に接するように平行に形成するものなどが挙げられる。
【0012】
図3に示す細管20の血液吸収性部材との接触端24の端面25には、吸入された血液が血液吸収性部材にスムーズに展開し、正確な測定値を得られるように、凹溝26を形成している。凹溝26の深さについては、特に限定しないが、0.01mm以上、好ましくは0.05mmから0.2mmが好ましい。
また平面27は、血液吸収性部材1接着や融着のど方法により固定することもできる。このことにより血液吸収性部材1が歪んだり波打つことにより端面25と間に隙間を生じ血液の展開が行われないことを防止することができる。
図5に示す凹溝24の細管との接触部分の周長D2は、細管20内の血液が該接触端の末端まで吸入でき、血液吸収性部材1と血液が接触し、展開されるように、細管の半径をrとすると、D2≦2×π×r×50%が望ましい。
【0013】
また図1示す通り血液吸収性部材1とホルダー2との間に、血液の展開できる隙間28を確保している。隙間の高さは0.02mm以上、好ましくは0.05mm〜0.2mmがよい。
凹溝26の形状は、図3及び図5の形状に限定されず、一部皮膚に触れない構造を有していればよい。他にも例えば、複数の凹溝を細管20を中心に放射状に形成したり、細管20に接するように平行に形成するものなどが挙げられる。
図6に示す通り、ホルダー2には、血液吸収性部材1を固着するための固着部30、及び測定器200と定位置でセットできるように、嵌合部40が形成されている。
【0014】
測定器200には、呈色強度を光学的に測定し、測定値へ換算、表示するものや、成分量に応じた電位変化を電気的に測定し、測定値へ換算、表示するものが知られている。こういった血液測定に置ける誤差要因の1つとして、血液のヘマトクリット値の個人差があげられる。ヘマトクリット値は、血液中に占める赤血球の容積であるが、成人女性で35%〜45%、成人男性で40%〜50%、新生児では60%を越える場合も多く、性差、年齢差等の個人差が大きい。従って、血清を分離せず全血を検体とした検査においては、一定量の血液が血液吸収性部材1へ供給されても、血清の量にバラツキを生じるため、これが測定誤差要因となっている。こういった誤差を生じる検査の例としては、血糖値、コレステロール値、尿酸値、クレアチニン値、ナトリウム等の無機イオン値等の血清成分の検査があげられる。
【0015】
測定器200は、ヘマトクリット値を、試薬の呈色速度により判別し、血液中の測定成分の測定値を補正する。該呈色速度は、測定時間途中での、測定値の差を測定することによって得られる。該呈色速度の測定のタイミングとしては、ヘマトクリット値によって速度に差を生じやすい、呈色開始から間もない0秒と6秒間の任意の2点、好ましくは0秒と4秒間の任意の2点がよい。
病院での測定等、患者等の第3者の血液に触れ、B型肝炎やエイズ等のおそれがある場合には、図7に示すとおり、測定後ホルダー2を測定器200から外す際、ホルダーに2直接触れないように、測定器200に突きだしピン210、かつ、ホルダーにフランジ部50を設け、取り外し機構が設けられる。また、図示されてはいないが、バネじかけや、電磁石を利用した取り外し機構でもよい。
【0016】
(実施例1)
アクリル樹脂を材質として、表1のとおりホルダーを成形した。各ホルダーは、空気0.7torr下、プラズマ処理して親水化し、試薬を含まない、厚さ約150μmのポリスルホン膜を、血液吸収性部材としてホルダーに融着して、血液を吸入させた。必要血液量はいずれも細管体積よりほぼ5μl以上であり、指を穿刺後、湧出した血液約20μlの中心部から、吸入口先端を指へすばやく押し当て、ポリスルホン膜上に血液が展開するか否かによって、血液の吸入を比較確認した。表2に示す通り、本発明に係わるサンプル1が優れており、凹溝が有効であることが明らかである。
【0017】
【表1】

Figure 0003789557
【0018】
【表2】
Figure 0003789557
【0019】
(実施例2)
表3のホルダーを成形し、実施例1と同様の方法で処理し、これに表4の組成からなる試薬溶液を含浸し、40℃で30分間乾燥させた厚さ約150μmのポリスルホン膜を融着し、血糖値約100mg/dl及び400mg/dlの検体を用いて、血糖値の測定を繰り返し約30回行った。表2に示す通り、本発明に係わるサンプル3が優れており、凹溝が有効であることが明らかである。
【0020】
【表3】
Figure 0003789557
【0021】
【表4】
Figure 0003789557
【0022】
【表5】
Figure 0003789557
【0023】
(実施例3)
実施例2で作成したサンプル3を使用して、ヘマトクリット値30%、40%、50%、60%の血液を作成して、これに同じ血糖値となるようグルコースを添加した。色差計(日本分光社、シグマ80)を使用して、2秒毎に反射率から血糖値を測定した。表6及び7より、反応速度(血糖値の2秒値−0秒値の差)から、測定時間(20秒)における血糖値を短時間でも正確な値を得ることが可能である。尚、表6に対応する線グラフ1(図10)及び表7に対応する線グラフ2(図11)から、4秒値他でも同様の補正が可能である。また表6及び7から求めた具体的な補正値を表8に未補正値との比較を表9に示す。
【0024】
【表6】
Figure 0003789557
【0025】
【表7】
Figure 0003789557
【0026】
【表8】
Figure 0003789557
【0027】
【表9】
Figure 0003789557
【0028】
【発明の効果】
以上述べたように、本発明の血液検査具及び測定器によれば、血液の形態、採取部位、及び採取手技によらず、簡便に血液を採取でき、また正確な測定値を得ると共に、血液検査具廃棄時の安全性が得られる。
【図面の簡単な説明】
【図1】本発明の血液検査具の縦断面図である。
【図2】細管20の吸入口先端の外観拡大図である。
【図3】細管20の血液吸収性部材接触端の外観拡大図である。
【図4】図2に示す吸入口先端の上面図である。
【図5】図3に示す血液吸収性部材接触端の上面図である。
【図6】血液検査具の使用状態の模式図である。
【図7】血液検査具と血液検査測定器とを組み合わせ状態を示す縦断面図である。
【図8】先行技術実公昭60−38216の実施例である。
【図9】先行技術特開平3−99265の実施例である。
【図10】表6に対応する線グラフである。
【図11】表7に対応する線グラフである。
【符号の説明】
1 血液吸収性部材
2 ホルダー
20 細管
21 吸入口側端
22 吸入口側端面
23 吸入口側凹溝
24 血液吸収性部材との接触端
25 血液吸収性部材との接触端面
26 接触端面凹溝
30 固着部
40 嵌合部
50 フランジ
200 測定器
210 突き出しピン
300 血液
a 液体分析用器具
b 試薬層
c 液体吸収層
e 小孔
ア 液体分析用器具
イ 液体吸収性部材
ウ 試薬層
エ 器具本体
オ 細管[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a blood test tool and a measuring instrument for measuring a specific component in blood.
[0002]
[Prior art]
Japanese Utility Model Publication No. 60-38216 is known as a conventional blood test tool. As shown in FIG. 8, the liquid analysis instrument a has a reagent layer b, a liquid absorption layer c, and a covering member d that react with specific components in the liquid, and a small hole is formed in the uppermost covering member d. e is provided. And this liquid analysis instrument a is used as follows. That is, blood is applied onto the small hole e of the covering member d. The applied blood is diffused in the liquid absorbent member c through the small holes e, eventually reaches the reagent layer b, and causes a color reaction by the reagent contained in the reagent layer b. A specific component in blood is measured by measuring the coloration after the elapse of a certain time with a measuring instrument.
[0003]
In order to measure a specific component in blood using the liquid analysis instrument a as described above, sufficient blood must be supplied to the liquid absorbent member c from the small hole e as necessary. However, the blood of the sample is punctured with a scalpel or a needle or the like, and a very small amount is collected on the skin by the operation of squeezing the blood. Since e is only provided, the position of the small hole e is confirmed by the fingertip, so blood is attached around the small hole e and the blood attached to the fingertip cannot be supplied to the small hole e well. It was. In addition, when blood on the fingertip spreads without being spherical, or when blood is collected from the abdominal wall or earlobe, it is very difficult to supply to the small hole e.
[0004]
In order to solve such a problem, Japanese Patent Laid-Open No. 3-99265 is known. As shown in FIG. 9, this liquid analysis instrument A has an instrument main body d having a liquid absorbent member a and a reagent layer c on one side, a liquid absorption opening at one end, and the other end absorbing the liquid. A thin tube O is provided so as to be in contact with the sex member i. While this invention has solved the above problems, it has created new problems. When blood is absorbed by capillary action from a fingertip or the like by capillary action, if the capillary tip is pressed against the skin surface and the capillary tube is blocked, blood supply from the skin stops before the necessary amount of blood is absorbed. Measurement could not be started or accurate measurement could not be performed.
Also, when removing a blood test instrument from the measuring instrument, especially when measuring the blood of a third person in a ward or the like, there is a risk that the measurer touches the blood of the third person and may infect hepatitis B, AIDS, etc. .
[0005]
[Problems to be solved by the invention]
The object of the present invention is to allow blood to be collected easily and to obtain an accurate measurement value regardless of the blood form, collection site, and collection technique as described above, and to ensure safety when discarding the blood test device. It is to provide a blood test tool and a blood test measuring device in consideration.
[0006]
[Means for solving problems]
The above object is achieved by the following inventions (1) to (6).
(1) A blood-absorbing member carrying a reagent that reacts with a component in blood, a blood inlet at one end, a blood outlet at the other end, and the end surface on the outlet side is the blood-absorbing member In a blood test device provided with a capillary tube that contacts
A blood test tool characterized in that a concave groove A communicating with the suction port is provided on an end surface on the suction port side of the narrow tube.
(2) The blood test tool according to (1), wherein the circumferential length of the contact portion of the concave groove A with the narrow tube occupies 50% or less of the entire circumference of the end surface on the inlet side. The lower limit of the circumference is not particularly limited as long as blood can flow, but it may be 1% or more, preferably 10% or more.
[0007]
(3) The blood test tool according to (1) or (2) above, wherein a concave groove B communicating with the discharge port is provided on an end surface on the discharge port side of the thin tube.
(4) The blood test device according to any one of (1) to (3), wherein a circumferential length of a contact portion of the concave groove B with the narrow tube occupies 50% or less of an entire circumference of the suction port side end surface. The lower limit of the circumference is not particularly limited as long as blood can flow, but it may be 1% or more, preferably 10% or more.
(5) A means for measuring a hematocrit value of blood based on a reaction rate between a blood component and a reagent carried on the blood-absorbing member, and correcting the measured value of the component in the blood based on the hematocrit value, (1) The blood test measuring device which measures the component in the blood with the blood test tool as described in thru | or (4).
(6) The blood test measuring device according to (5) above, comprising a mechanism that can be removed without touching the blood test tool.
[0008]
DETAILED DESCRIPTION OF THE INVENTION
Hereinafter, the blood test tool and blood test measuring instrument of the present invention will be described in detail with reference to the accompanying drawings.
1 is a longitudinal sectional view showing an embodiment of a blood test device of the present invention, FIGS. 2 and 3 are perspective views of both ends of the narrow tube shown in FIG. 1, FIGS. 4 and 5 are top views of both ends of the narrow tube, and FIG. Is a longitudinal view showing the usage state of the blood test tool, and FIG. 7 is a longitudinal sectional view showing the combined usage state of the blood test tool and the blood test measuring instrument.
A blood test instrument 100 of the present invention shown in FIG. 1 is mainly composed of a blood absorbent member 1 carrying a reagent that reacts with components in blood and a holder 2 having a thin tube 20 for blood inhalation. . Hereinafter, each component will be described.
The blood absorbent member 1 is obtained by impregnating a reagent with a porous membrane as a carrier. The porous membrane desirably has a pore size that can filter out red blood cells in blood. By using a porous membrane, especially in a reagent system that includes a process of reacting with oxygen in the atmosphere as a substrate, such as an oxidase reaction, even after the sample is spread on the reagent layer, the sample receiving side is covered with the sample. By supplying atmospheric oxygen from the opposite side, the reaction can be rapidly advanced, and color development can be observed without removing the sample.
[0009]
Examples of the material of the porous membrane include polyesters, polyamides, polyolefins, polysulfones, and celluloses. However, the porous membrane is impregnated with an aqueous solution in which a reagent is dissolved, or a blood cell is filtered during measurement. Or the material made hydrophilic is preferable. Hydrophilization can be performed by plasma activation, glow discharge, corona discharge, physical activation treatment such as ultraviolet irradiation, and coating of surfactant, water-soluble silicon, hydroxypropylcellulose, polyethylene glycol, polypropylene glycol, and the like.
As a reaction reagent, an oxidative condensation reaction of 4-aminoantipyrine with the above hydrogen donor in the presence of oxidase and peroxidase is known.
As will be described later, the blood absorbent member 1 is fixed to the holder 2 by adhesion or fusion.
[0010]
The holder 2 shown in FIG. 1 includes a thin tube 20, a fixing part 30 with a blood absorbing member, a fitting part 40 with a measuring instrument, and a flange 50. Each component is integrally formed by molding, but may be configured by combining different parts.
The holder 2 is made of a rigid material having a predetermined rigidity. Examples of the material include acrylic resin, polystyrene, polypropylene, polyethylene, hard polyvinyl chloride, polycarbonate, ABS resin, polyester, polyphenylene sulfide (PPS), etc., but acrylic resin is used to inhale and develop blood during measurement. A highly hydrophilic material or a hydrophilic material is preferable. Hydrophilization can be performed by plasma activation, glow discharge, corona discharge, physical activation treatment such as ultraviolet irradiation, and coating of surfactant, water-soluble silicon, hydroxypropylcellulose, polyethylene glycol, polypropylene glycol, and the like.
[0011]
A concave groove 23 is formed on the end face 22 of the blood inlet side end 21 of the thin tube 20 shown in FIG. 2 so as not to be blocked by the skin of the blood collection site and hinder blood inhalation. The circumferential length D1 of the contact portion with the narrow tube of the groove 23 shown in FIG. 4 (a) and FIG. 4 (b) which is a cross section of the line segment II ′ is not so large as to prevent the start of blood inhalation. If the radius of the narrow tube is r, D1 ≦ 2 × π × r × 50% is desirable.
The depth P of the concave groove 23 shown in FIG. 6 is 0.1 mm or more, preferably 0.2 mm to 1 mm, which does not block the tubule 20 with the skin, although it depends on the state of the skin. The shape of the ditch | groove 23 is not limited to the shape of FIG.2 and FIG.4, What is necessary is just to have a structure which does not touch skin partially. In addition, for example, a plurality of concave grooves may be formed radially around the thin tube 20 or may be formed in parallel so as to be in contact with the thin tube 20.
[0012]
On the end face 25 of the contact end 24 of the capillary tube 20 shown in FIG. 3 with the blood absorbent member, the recessed groove 26 is provided so that the inhaled blood can be smoothly spread on the blood absorbent member and an accurate measurement value can be obtained. Is forming. The depth of the concave groove 26 is not particularly limited, but is 0.01 mm or more, preferably 0.05 mm to 0.2 mm.
The flat surface 27 can also be fixed by the blood-absorbing member 1 adhesion or fusion throat method. As a result, it is possible to prevent the blood absorbing member 1 from being distorted or undulated, thereby creating a gap between the end face 25 and preventing blood from being developed.
The peripheral length D2 of the contact portion of the concave groove 24 shown in FIG. 5 with the narrow tube is such that the blood in the narrow tube 20 can be sucked up to the end of the contact end, and the blood absorbent member 1 and the blood are brought into contact with each other and deployed. When the radius of the narrow tube is r, D2 ≦ 2 × π × r × 50% is desirable.
[0013]
Further, as shown in FIG. 1, a gap 28 through which blood can be developed is secured between the blood absorbent member 1 and the holder 2. The height of the gap is 0.02 mm or more, preferably 0.05 mm to 0.2 mm.
The shape of the groove 26 is not limited to the shape shown in FIGS. 3 and 5, as long as it has a structure that does not partially touch the skin. In addition, for example, a plurality of concave grooves may be formed radially around the thin tube 20 or may be formed in parallel so as to be in contact with the thin tube 20.
As shown in FIG. 6, the holder 2 is formed with a fixing portion 30 for fixing the blood-absorbing member 1 and a fitting portion 40 so as to be set at a fixed position with the measuring device 200.
[0014]
The measuring device 200 is known to optically measure the color intensity, convert it to a measured value and display it, or to electrically measure the potential change according to the amount of the component, convert it to a measured value, and display it. It has been. One of the error factors in such blood measurement is the individual difference in blood hematocrit. The hematocrit value is the volume of red blood cells in the blood, but it often exceeds 35% to 45% for adult women, 40% to 50% for adult men, and 60% for newborns. The difference is big. Therefore, in a test using whole blood as a specimen without separating serum, even if a certain amount of blood is supplied to the blood-absorbing member 1, the amount of serum varies, which is a measurement error factor. . Examples of tests that cause such errors include tests for serum components such as blood sugar levels, cholesterol levels, uric acid levels, creatinine levels, and inorganic ion levels such as sodium.
[0015]
The measuring device 200 discriminates the hematocrit value based on the coloration rate of the reagent, and corrects the measured value of the measurement component in the blood. The coloration speed can be obtained by measuring the difference in measured values during the measurement time. The timing of measuring the coloration speed is likely to cause a difference in speed depending on the hematocrit value. Any two points of 0 seconds and 6 seconds immediately after the start of coloration, preferably any two of 0 seconds and 4 seconds. The point is good.
When there is a risk of hepatitis B, AIDS, etc. when touching the blood of a third party such as a patient, such as measurement at a hospital, the holder 2 is removed from the measuring instrument 200 as shown in FIG. 2 is provided with a protruding pin 210 on the measuring instrument 200 and a flange portion 50 on the holder, and a removing mechanism is provided. Further, although not shown, a spring mechanism or a detaching mechanism using an electromagnet may be used.
[0016]
Example 1
A holder was molded as shown in Table 1 using acrylic resin as a material. Each holder was hydrophilized by plasma treatment under air at 0.7 torr, and a polysulfone membrane having a thickness of about 150 μm and containing no reagent was fused to the holder as a blood-absorbing member to inhale blood. The required blood volume is almost 5 μl or more than the capillary volume. After puncturing a finger, the tip of the inlet is quickly pressed against the finger from the center of about 20 μl of blood that has spouted, and the blood is spread on the polysulfone membrane. The blood inhalation was compared and confirmed. As shown in Table 2, it is clear that Sample 1 according to the present invention is excellent and that the groove is effective.
[0017]
[Table 1]
Figure 0003789557
[0018]
[Table 2]
Figure 0003789557
[0019]
(Example 2)
A holder shown in Table 3 was molded, treated in the same manner as in Example 1, impregnated with a reagent solution having the composition shown in Table 4, and dried at 40 ° C. for 30 minutes to melt a polysulfone membrane having a thickness of about 150 μm. The blood glucose level was repeatedly measured about 30 times using samples having blood glucose levels of about 100 mg / dl and 400 mg / dl. As shown in Table 2, it is clear that the sample 3 according to the present invention is excellent and the groove is effective.
[0020]
[Table 3]
Figure 0003789557
[0021]
[Table 4]
Figure 0003789557
[0022]
[Table 5]
Figure 0003789557
[0023]
Example 3
Using the sample 3 prepared in Example 2, blood with a hematocrit value of 30%, 40%, 50%, and 60% was prepared, and glucose was added thereto so that the blood sugar level was the same. The blood glucose level was measured from the reflectance every 2 seconds using a color difference meter (JASCO Corporation, Sigma 80). From Tables 6 and 7, it is possible to obtain an accurate value of the blood glucose level in the measurement time (20 seconds) from the reaction rate (difference between the 2-second value of the blood glucose level and the 0-second value) even in a short time. It should be noted that the same correction can be made for the 4 second value and others from the line graph 1 corresponding to Table 6 (FIG. 10) and the line graph 2 corresponding to Table 7 (FIG. 11). Further, specific correction values obtained from Tables 6 and 7 are shown in Table 8, and comparison with uncorrected values is shown in Table 9.
[0024]
[Table 6]
Figure 0003789557
[0025]
[Table 7]
Figure 0003789557
[0026]
[Table 8]
Figure 0003789557
[0027]
[Table 9]
Figure 0003789557
[0028]
【The invention's effect】
As described above, according to the blood test tool and the measuring instrument of the present invention, blood can be easily collected regardless of the blood form, the collection site, and the collection technique, and an accurate measurement value can be obtained. Safety at the time of disposal of the inspection tool can be obtained.
[Brief description of the drawings]
FIG. 1 is a longitudinal sectional view of a blood test tool according to the present invention.
FIG. 2 is an enlarged external view of the tip of the suction port of the thin tube 20;
3 is an enlarged external view of a blood absorbent member contact end of a thin tube 20. FIG.
4 is a top view of the tip of the suction port shown in FIG. 2. FIG.
FIG. 5 is a top view of the blood absorbent member contact end shown in FIG. 3;
FIG. 6 is a schematic view of a blood test tool in use.
FIG. 7 is a longitudinal sectional view showing a combined state of a blood test tool and a blood test measuring instrument.
FIG. 8 is an example of Japanese Unexamined Patent Application Publication No. 60-38216.
FIG. 9 is an example of Japanese Patent Laid-Open No. 3-99265.
10 is a line graph corresponding to Table 6. FIG.
11 is a line graph corresponding to Table 7. FIG.
[Explanation of symbols]
DESCRIPTION OF SYMBOLS 1 Blood absorptive member 2 Holder 20 Narrow tube 21 Inlet port side end 22 Inlet port side end surface 23 Inlet port side ditch 24 Contact end surface with blood absorptive member 25 Contact end surface with blood absorptive member 26 Contact end surface ditch 30 Adherence Part 40 Fitting part 50 Flange 200 Measuring instrument 210 Protrusion pin 300 Blood a Liquid analyzer b Reagent layer c Liquid absorption layer e Small hole A Liquid analysis instrument B Liquid absorbent member C Reagent layer D Instrument body O Capillary tube

Claims (6)

血液中の成分と反応を示す試薬が担持された血液吸収性部材と、一端に血液吸入口を有し他端に血液排出口を有し、前記排出口側端面が前記血液吸収部材に接触し、血液を毛細管現象で吸収する細管とを備えた血液検査具において、
前記細管の吸入口側端面に、前記細管と直交し前記吸入口と連通する直線状の凹溝Aを設けたことを特徴とする血液検査具。
A blood-absorbing member carrying a reagent that reacts with components in the blood, a blood inlet at one end and a blood outlet at the other end, and the end surface on the outlet side contacts the blood-absorbing member. In a blood test instrument having a capillary that absorbs blood by capillary action,
A blood test tool characterized in that a linear concave groove A that is orthogonal to the thin tube and communicates with the suction port is provided on an end surface on the suction port side of the thin tube.
前記凹溝Aの細管との接触部分の周長が前記細管の周長の50%以下を占める請求項1に記載の血液検査具。The blood test tool according to claim 1, wherein the peripheral length of the contact portion of the concave groove A with the thin tube occupies 50% or less of the peripheral length of the thin tube. 前記凹溝Aの深さは、0.2mmから1mmである請求項1または2に記載の血液検査具。The blood test tool according to claim 1 or 2, wherein the depth of the concave groove A is 0.2 mm to 1 mm. 前記細管の排出口側端面に、前記排出口と連通する凹溝Bを設けたことを特徴とする請求項1乃至3に記載の血液検査具。The blood test tool according to any one of claims 1 to 3, wherein a concave groove B communicating with the discharge port is provided on an end surface on the discharge port side of the thin tube. 前記凹溝Bの細管との接触部分の周長が前記細管の周長の50%以下を占める請求項4に記載の血液検査具。The blood test tool according to claim 4, wherein the circumferential length of the contact portion of the concave groove B with the narrow tube occupies 50% or less of the circumferential length of the narrow tube. 請求項1乃至5に記載の血液検査具を触れることなく取り外すことのできる機構を備えたことを特徴とする血液検査測定器。A blood test measuring instrument comprising a mechanism that can be removed without touching the blood test tool according to claim 1.
JP17207296A 1996-07-02 1996-07-02 Blood test tool and blood test measuring instrument Expired - Fee Related JP3789557B2 (en)

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JPH11183474A (en) * 1997-12-24 1999-07-09 Terumo Corp Test paper and chip for component measurement
US20100004559A1 (en) * 2006-12-19 2010-01-07 National Institute Of Advanced Industrial Science And Technology Biosensor cartridge, method of using biosensor cartridge, biosensor device, and needle integral sensor
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CN102670209A (en) 2007-09-07 2012-09-19 泰尔茂株式会社 Blood sugar measuring method
US20100256473A1 (en) 2007-11-19 2010-10-07 Terumo Kabushiki Kaisha Blood glucose level measuring system and measurement data managing device
CN101903763B (en) 2007-12-20 2013-02-13 泰尔茂株式会社 Blood sugar measured level management system and blood sugar level measurement apparatus
JP5033752B2 (en) 2008-09-30 2012-09-26 テルモ株式会社 Blood glucose level measuring device and measurement data management device
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