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JP2020085505A - Disposable test piece and analyzer using the test piece - Google Patents

Disposable test piece and analyzer using the test piece Download PDF

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JP2020085505A
JP2020085505A JP2018215899A JP2018215899A JP2020085505A JP 2020085505 A JP2020085505 A JP 2020085505A JP 2018215899 A JP2018215899 A JP 2018215899A JP 2018215899 A JP2018215899 A JP 2018215899A JP 2020085505 A JP2020085505 A JP 2020085505A
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sample liquid
sample
valve
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liquid
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JP7150324B2 (en
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美月 富澤
Mitsuki Tomizawa
美月 富澤
金宗 檀
Kaneso Dan
金宗 檀
博也 鈴木
Hiroya Suzuki
博也 鈴木
善太 加藤
Zenta Kato
善太 加藤
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Techno Medica Co Ltd
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Techno Medica Co Ltd
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Abstract

To provide a maintenance-free disposable test piece and an analyzer using the test piece with a simple structure at a low manufacturing cost, capable of reducing the effects of air exposure and sedimentation of sample blood cell and the measurement conditions are less susceptible to variations due to human factors.SOLUTION: The disposed disposable test piece is configured to calibrate a measuring unit with a valve closed. After calibrating the measuring unit, the sample liquid is introduced from a sample liquid introducing unit and held in a sample liquid holding unit, and subsequently, the valve is opened and the sample liquid held in the sample liquid holding unit is pushed out toward the measurement unit by sample liquid supply means.SELECTED DRAWING: Figure 1

Description

本発明は、血液検体中のガス分圧や電解質成分等の測定や分析を行うために用いられる使い捨て検査具及び該検査具を用いる分析装置に関する。 The present invention relates to a disposable test tool used for measuring and analyzing a gas partial pressure, an electrolyte component, etc. in a blood sample and an analyzer using the test tool.

血液ガス及び電解質成分を測定するには、正しい検体取り扱いが極めて重要である。採血した検体は空気との接触によってガス成分やpHの変化を引き起こす。特に酸素分圧が変わりやすい。また、時間の経過と共に血球沈降が生じ、それがヘマトクリットの測定に影響を及ぼし、また、電解質濃度のバラツキ要因にもなる。
使い捨て検査具を使う小型血液ガス測定装置においても、上記した問題は例外なく生じる。
現在、市場において実用化されている使い捨て検査具を使った小型血液ガス測定装置を用いて、血液ガス及び電解質成分を測定する方法としては、以下の三種類の方法がある。
第一の方法では、始めに、使い捨て検査具を血液ガス測定装置にセットして検査具の校正を行う。校正が終了した後に、検体を採取したシリンジ等を用いて検体を検査具の測定部まで注入して測定を行う(特許文献1)。
第二の方法では、使い捨て検査具を血液ガス分析装置にセットする前に検査具に検体を導入しておく。次いで、検体導入済の検査具を血液ガス測定装置にセットして、校正及び測定を行う(特許文献2)。
第三の方法では、採血したシリンジ等を直接、使い捨て検査具に装着する。次いで、シリンジが装着された検査具を血液ガス分析装置にセットする。血液ガス分析装置は、検査具の校正を行った後、検査具に装着されたシリンジから直接、検体を測定部まで吸引して、測定を行う(特許文献3)。
Correct sample handling is extremely important for measuring blood gas and electrolyte components. The collected blood sample causes a change in gas components and pH upon contact with air. Especially, the oxygen partial pressure tends to change. In addition, hemocyte sedimentation occurs with the passage of time, which affects the measurement of hematocrit and also causes variations in the electrolyte concentration.
Even in a small blood gas measuring device using a disposable test tool, the above-mentioned problems occur without exception.
At present, there are the following three types of methods for measuring blood gas and electrolyte components using a small blood gas measuring device using a disposable test tool that is put to practical use in the market.
In the first method, first, the disposable test tool is set in the blood gas measuring device and the test tool is calibrated. After the calibration is completed, the sample is injected to the measurement unit of the inspection tool using a syringe or the like from which the sample is collected, and measurement is performed (Patent Document 1).
In the second method, the sample is introduced into the test tool before the disposable test tool is set in the blood gas analyzer. Next, the test instrument with the introduced sample is set in the blood gas measuring device to perform calibration and measurement (Patent Document 2).
In the third method, a syringe or the like that has collected blood is directly attached to the disposable inspection tool. Next, the test device with the syringe attached is set in the blood gas analyzer. The blood gas analyzer calibrates the test tool and then sucks the sample directly to the measurement unit from the syringe attached to the test tool to perform the measurement (Patent Document 3).

特開平11−83783号公報JP-A-11-83783 特開平4−501768号公報JP-A-4-501768 米国特許8986527号US Pat. No. 8,986,527

上記した従来の使い捨て検査具には、以下のような問題がある。 The above-mentioned conventional disposable inspection tool has the following problems.

特許文献1に記載の第一の方法では、校正が終了した後に、操作者が、検体を採取したシリンジを用いて検体を検査具の測定部まで注入するため、検体が測定直前まで空気に暴露されることがなく、また、血液沈降による影響を最小限に抑えることができるという利点を有するが、作業者がシリンジを用いて検体を測定部まで注入するため、注入時の圧力や注入量等が操作者の操作に依存してしまうため、バラツキの要因になる。 In the first method described in Patent Document 1, after the calibration is completed, the operator injects the sample to the measurement unit of the inspection tool using the syringe that has collected the sample, so the sample is exposed to air until immediately before measurement. It has the advantage that it is not affected and that the effect of blood sedimentation can be minimized, but since the operator injects the sample to the measurement part using a syringe, the pressure and injection amount at the time of injection etc. Depends on the operation of the operator, which causes variation.

特許文献2に記載の第二の方法においては、予め検体を検査具に入れておき、血液ガス測定装置の動作により、校正後に自動的に検体を測定部に移動させるように構成されているため、検体を測定部に送る圧力や量等を一定に保つことができるという利点を有するが、予め検体を検査具に入れておくため、校正を実施している間に、検体が検査具のハウジング周りの材料と接触することで空気暴露され、かつ、血球沈降が生じるという問題がある。 In the second method described in Patent Document 2, the sample is put in the test tool in advance, and the sample is automatically moved to the measurement unit after the calibration by the operation of the blood gas measuring device. It has the advantage that the pressure and amount to send the sample to the measurement unit can be kept constant, but since the sample is put in the test tool in advance, the sample is stored in the housing of the test tool during calibration. There is a problem that air exposure and blood cell sedimentation occur due to contact with surrounding materials.

さらに、特許文献3に記載の第三の方法は、検体採取済のシリンジを検査具にセットした後、血液ガス測定装置に装着し、検査具の校正後に、検体吸引ノズルを介してポンプでシリンジから検体を吸引して、測定部まで引き込むように構成されているため、空気暴露を受け難く、かつ、ポンプを用いた吸引によって検体をシリンジから測定部まで引き込むため、検体を測定部に送る圧力及び量等を一定に保つことができるという利点を有するが、予めシリンジを検査具にセットしなければならないため、校正の間に血球沈降が生じる可能性がある。そしてなによりも、シリンジから吸引ノズルを介してポンプで検体を測定部まで吸引するという構成は、測定装置の構造を非常に複雑なものにし、また、使い捨て検査具に検体を吸引するノズルを取り付ける工程が複雑であり、その結果、製造コストが上がってしまう。 Furthermore, the third method described in Patent Document 3 is to set a syringe from which a sample has been collected on a test tool, mount the syringe on a blood gas measuring device, and after calibrating the test tool, use a pump via a sample suction nozzle to pump the syringe. Since it is configured to aspirate the sample from the sample to the measuring section, it is difficult to be exposed to air, and because the sample is drawn from the syringe to the measuring section by suction using a pump, the pressure to send the sample to the measuring section. It has an advantage that the amount and the like can be kept constant, but since the syringe has to be set in the test tool in advance, blood cell sedimentation may occur during the calibration. And above all, the structure of sucking the sample from the syringe to the measuring section with the pump through the suction nozzle makes the structure of the measuring device very complicated, and the nozzle for sucking the sample is attached to the disposable testing tool. The process is complicated, resulting in higher manufacturing costs.

本発明は、上記した従来の問題点を解決し、測定装置の構造を複雑化して製造コストを高くすることなく、かつ、メンテナンスを大変にすることもなく、検体の空気暴露及び血球沈降の影響を少なくすることができ、かつ、人的な要因による測定条件のバラツキを受け難い使い捨て検査具及び該検査具を用いる分析装置を提供することを目的としている。 The present invention solves the above-mentioned conventional problems, does not increase the manufacturing cost by complicating the structure of the measuring device, and does not make maintenance difficult, and the influence of air exposure and blood cell sedimentation of the sample. It is an object of the present invention to provide a disposable inspection tool that is less susceptible to variations in measurement conditions due to human factors and an analyzer that uses the inspection tool.

上記した目的を達成するために、本発明に係る使い捨て検査具は、ハウジングの内部に検体液通路を設け、前記検体液通路の上流部分に、検体液導入部を設け、下流部分に廃液溜め部を設けると共に、 前記検体液通路における検体液導入部と廃液溜め部との間に、検体液中の少なくとも一つの成分を計測可能な計測部を設け、前記計測部の計測結果に基づいて検体液中の少なくとも一つの成分を分析装置で分析できるように構成された分析装置用使い捨て検査具において、前記検体液通路における前記検体液導入部と前記計測部との間に、バルブを設け、前記検体液通路における前記検体液導入部と前記バルブとの間に、検体を一時的に保持する検体液保持部と、前記検体液保持部に保持された検体を前記計測部に向けて押し出す検体液供給手段を設け、前記検体液通路における前記バルブと前記計測部との間に、そこから分岐する校正液通路を設け、前記校正液通路に校正液供給手段を設けて成り、前記バルブを閉弁した状態で、前記計測部の校正を行い、計測部の校正後に前記検体液導入部から検体液を導入して前記検体液保持部に保持し、次いで、バルブを開弁して前記検体液供給手段により検体液保持部に保持されている検体液を計測部に向けて押し出すことができるように構成されている。 In order to achieve the above-mentioned object, the disposable testing tool according to the present invention is provided with a sample liquid passage inside a housing, a sample liquid introducing portion is provided at an upstream portion of the sample liquid passage, and a waste liquid collecting portion is provided at a downstream portion. With the provision of a measuring unit capable of measuring at least one component in the sample liquid between the sample liquid introducing unit and the waste liquid reservoir unit in the sample liquid passage, the sample liquid based on the measurement result of the measuring unit. In the disposable testing device for an analyzer configured to be able to analyze at least one component in the analyzer, a valve is provided between the sample liquid introducing part and the measuring part in the sample liquid passage, and the sample Between the sample liquid introduction part and the valve in the liquid passage, a sample liquid holding part for temporarily holding the sample, and a sample liquid supply for pushing the sample held in the sample liquid holding part toward the measuring part. Means is provided, a calibration liquid passage branched from the valve and the measurement unit in the sample liquid passage is provided, and a calibration liquid supply means is provided in the calibration liquid passage, and the valve is closed. In this state, the measurement unit is calibrated, and after the measurement unit is calibrated, a sample liquid is introduced from the sample liquid introduction unit and held in the sample liquid holding unit, and then a valve is opened to open the sample liquid supply unit. With this configuration, the sample liquid held in the sample liquid holding unit can be pushed out toward the measuring unit.

前記検体液供給手段は、好ましくは、前記検体液保持部に接続された空気保持部を有し得、前記空気保持部を加圧することによって、該空気保持部内に保持された空気で、前記検体液保持部内に保持された検体液を計測部まで押し出すように構成され得る。この場合、好ましくは、前記ハウジングにおける前記空気保持部に対応する部分を変形可能に構成され得る。 The sample liquid supply means may preferably have an air holding part connected to the sample liquid holding part, and the air held in the air holding part by pressurizing the air holding part, It may be configured to push the sample liquid held in the liquid holding unit to the measuring unit. In this case, preferably, the portion of the housing corresponding to the air holding portion can be configured to be deformable.

また、前記検体液通路における検体液保持部とバルブとの間に、そこから分岐する分岐通路を設け、該分岐通路に前記検体液保持部が検体に満たされることを検出可能な検体液検出部が設けられ得る。 Further, a branch passage branching from the specimen liquid holding unit and the valve in the specimen liquid passage is provided, and a specimen liquid detecting unit capable of detecting that the specimen liquid holding unit is filled with the specimen in the branch passage. Can be provided.

また、本発明に係る分析装置は、上記した使い捨て検査具を用いて検体液中の少なくとも一つの成分を分析するように構成された分析装置であって、前記使い捨て検査具を装着可能な検査具装着部と、前記使い捨て検査具における計測部からの計測信号を入力可能な計測信号入力部と、前記使い捨て検査具におけるバルブを開閉するバルブ作動装置と、前記使い捨て検査具における検体液供給手段を作動する検体液供給手段作動装置と、前記使い捨て検査具における前記校正液供給手段を作動する校正液供給手段作動装置と、制御装置とを備え、検査具装着部に使い捨て検査具が装着されると、バルブを閉弁した後、前記校正液供給手段作動装置を作動させて校正液を計測部に供給して計測部の校正を実行し、次いで、検体液保持部が検体で満たされて、検体液検出部で検体液を検出するまで待機し、検体液検出部で検体液を検出したら前記バルブを開弁して、前記検体液供給手段作動装置を作動させて検体液保持部に保持された検体液を計測部に供給して、計測部において検体液の少なくとも一つの成分を計測するように、制御装置が前記各装置の動作を制御するよう構成されている。 Further, an analyzer according to the present invention is an analyzer configured to analyze at least one component in a sample liquid using the above-mentioned disposable test tool, and the test tool capable of mounting the disposable test tool. A mounting part, a measurement signal input part capable of inputting a measurement signal from a measuring part in the disposable test tool, a valve operating device for opening and closing a valve in the disposable test tool, and a sample liquid supply means in the disposable test tool. A sample liquid supply means operating device, a calibration liquid supply means operating device that operates the calibration liquid supply means in the disposable inspection tool, and a control device, and when the disposable inspection tool is attached to the inspection tool attachment portion, After closing the valve, the calibration liquid supply means operating device is operated to supply the calibration liquid to the measurement unit to calibrate the measurement unit, and then the sample liquid holding unit is filled with the sample, Standby until the sample liquid is detected by the detection unit, and when the sample liquid is detected by the sample liquid detection unit, the valve is opened and the sample liquid supply means operating device is operated to hold the sample held in the sample liquid holding unit. The control device is configured to control the operation of each of the devices so as to supply the liquid to the measuring unit and measure at least one component of the sample liquid in the measuring unit.

本発明に係る使い捨て検査具は、ハウジングの内部に検体液通路を設け、前記検体液通路の上流部分に、検体液導入部を設け、下流部分に廃液溜め部を設けると共に、前記検体液通路における検体液導入部と廃液溜め部との間に、検体液中の少なくとも一つの成分を計測可能な計測部を設け、前記計測部の計測結果に基づいて検体液中の少なくとも一つの成分を分析装置で分析できるように構成された分析装置用使い捨て検査具において、前記検体液通路における前記検体液導入部と前記計測部との間に、バルブを設け、前記検体液通路における前記検体液導入部と前記バルブとの間に、検体を一時的に保持する検体液保持部と、前記検体液保持部に保持された検体を前記計測部に向けて押し出す検体液供給手段を設け、前記検体液通路における前記バルブと前記計測部との間に、そこから分岐する校正液通路を設け、前記校正液通路に校正液供給手段を設けて成り、前記バルブを閉弁した状態で、前記計測部の校正を行い、計測部の校正後に前記検体液導入部から検体液を導入して前記検体液保持部に保持し、次いで、バルブを開弁して前記検体液供給手段により検体液保持部に保持されている検体液を計測部に向けて押し出すことができるように構成されているので、バルブを閉弁した状態で検体液を検体液通路の導入することで、シリンジ等の検体採取具から検体液通路に導入される検体液を直接計測部に送らずに、一度、検体液保持部に保持することができ、次いで、バルブを開弁して検体液供給手段によって検体液を計測部に送ることができる。これにより、シリンジ等の検体液採取具から計測部に検体液を導入する時に導入圧力や導入量にバラツキが生じることがない。また本発明に係る検査具によれば、校正が終了した後に、シリンジ等の検体採取具から検体液を検査具に導入することができるようになるため、計測部における計測直前まで検体液をシリンジ等の検体採取具内に収容しておくことが可能になる。このため、検査具内での検体液の空気暴露や血球沈降等の問題を最小限に抑えることができる。さらに、導入圧力及び導入量の問題に加えて、空気暴露の問題を解消するために、従来のように吸引ノズルを設けて検体採取具から検体を吸引する機構を設ける必要がないため、検査具の構造を複雑化することなく、製造コストも安価に抑えることが可能になる。 Disposable inspection tool according to the present invention, a sample liquid passage is provided inside the housing, a sample liquid introducing portion is provided at an upstream portion of the sample liquid passage, and a waste liquid reservoir portion is provided at a downstream portion, and in the sample liquid passage. A measuring unit capable of measuring at least one component in the sample liquid is provided between the sample liquid introducing unit and the waste liquid reservoir, and at least one component in the sample liquid is analyzed based on the measurement result of the measuring unit. In the disposable testing device for an analyzer configured to be able to analyze, a valve is provided between the sample liquid introducing part and the measuring part in the sample liquid passage, and the sample liquid introducing part in the sample liquid passage is provided. Between the valve and the sample liquid holding unit that temporarily holds the sample, and a sample liquid supply unit that pushes out the sample held in the sample liquid holding unit toward the measuring unit, and in the sample liquid passage A calibration liquid passage branched from the valve and the measurement unit is provided, and a calibration liquid supply unit is provided in the calibration liquid passage, and the calibration unit is calibrated with the valve closed. After the calibration of the measuring unit, the sample liquid is introduced from the sample liquid introducing unit and held in the sample liquid holding unit, and then the valve is opened and held in the sample liquid holding unit by the sample liquid supply unit. Since it is configured to push out the existing sample liquid toward the measurement unit, by introducing the sample liquid into the sample liquid passage with the valve closed, the sample liquid passage from the sample collecting tool such as a syringe can be introduced. It is possible to hold the sample liquid introduced into the sample liquid in the sample liquid holding unit once without directly sending it to the measuring unit, and then open the valve to send the sample liquid to the measuring unit by the sample liquid supply means. it can. As a result, when introducing the sample liquid from the sample liquid collecting tool such as a syringe into the measurement unit, the introduction pressure and the introduction amount do not vary. Further, according to the test tool of the present invention, after the calibration is completed, the sample liquid can be introduced into the test tool from the sample collecting tool such as a syringe. It becomes possible to store it in the sample collecting tool such as. Therefore, it is possible to minimize problems such as air exposure of the sample liquid and blood cell sedimentation in the test tool. Further, in addition to the problems of the introduction pressure and the introduction amount, in order to solve the problem of air exposure, it is not necessary to provide a mechanism for aspirating the sample from the sample collecting tool by providing a suction nozzle as in the conventional case. The manufacturing cost can be kept low without complicating the structure.

前記検体液供給手段に、前記検体液保持部に接続された空気保持部を設け、前記空気保持部を加圧することによって、該空気保持部内に保持された空気で、前記検体液保持部内に保持された検体液を計測部まで押し出すように構成することで、検体液供給手段による検体液の計測部への供給圧力及び供給量を簡単に一定に保つことが可能になる。さらに、この場合、前記ハウジングにおける前記空気保持部に対応する部分を変形可能に構成することで、プッシャー等で外部から押すことにより検体液保持部から検体液を押し出すことが可能になる。 The sample liquid supply means is provided with an air holding part connected to the sample liquid holding part, and by pressurizing the air holding part, the air held in the air holding part holds the sample liquid holding part in the sample liquid holding part. By configuring so that the sample liquid thus obtained is pushed out to the measurement unit, it becomes possible to easily keep the supply pressure and the supply amount of the sample liquid to the measurement unit by the sample liquid supply means constant. Further, in this case, by configuring the portion of the housing corresponding to the air holding portion to be deformable, it is possible to push out the sample liquid from the sample liquid holding portion by pushing from the outside with a pusher or the like.

また、前記検体液通路における検体液保持部とバルブとの間に、そこから分岐する分岐通路を設け、該分岐通路に検体液保持部が検体液で満たされたことを検出可能な検体液検出部を設けることで、検体液保持部への検体液の導入が容易になる。 Further, a branch passage branching from the specimen liquid holding unit and the valve in the specimen liquid passage is provided, and a specimen liquid detection capable of detecting that the specimen liquid holding unit is filled with the specimen liquid in the branch passage. By providing the portion, the sample liquid can be easily introduced into the sample liquid holding portion.

また、本発明に係る分析装置は、上記した使い捨て検査具を用いて検体液中の少なくとも一つの成分を分析するように構成された分析装置であって、前記使い捨て検査具を装着可能な検査具装着部と、前記使い捨て検査具における計測部からの計測信号を入力可能な計測信号入力部と、前記使い捨て検査具におけるバルブを開閉するバルブ作動装置と、前記使い捨て検査具における検体液供給手段を作動する検体液供給手段作動装置と、前記使い捨て検査具における前記校正液供給手段を作動する校正液供給手段作動装置と、制御装置とを備え、検査具装着部に使い捨て検査具が装着されると、バルブを閉弁した後、前記校正液供給手段作動装置を作動させて校正液を計測部に供給して計測部の校正を実行し、次いで、検体液保持部が検体で満たされて、前記検体液検出部で検体液が検出されるまで待機し、検体液検出部で検体液を検出したら前記バルブを開弁して、前記検体液供給手段作動装置を作動させて検体液保持部に保持された検体液を計測部に供給して、計測部において検体液の少なくとも一つの成分を計測するように、制御装置が前記各装置の動作を制御するよう構成されているので、上記した使い捨て検査具との組み合わせにより、検体液の導入圧力及び導入量のバラツキがなくなり、検体液の空気暴露及び血球沈降等の問題も生じない。 Further, an analyzer according to the present invention is an analyzer configured to analyze at least one component in a sample liquid using the above-mentioned disposable test tool, and the test tool capable of mounting the disposable test tool. A mounting part, a measurement signal input part capable of inputting a measurement signal from a measuring part in the disposable test tool, a valve operating device for opening and closing a valve in the disposable test tool, and a sample liquid supply means in the disposable test tool. A sample liquid supply means operating device, a calibration liquid supply means operating device that operates the calibration liquid supply means in the disposable inspection tool, and a control device, and when the disposable inspection tool is attached to the inspection tool attachment portion, After closing the valve, the calibration liquid supply means operating device is operated to supply the calibration liquid to the measurement unit to calibrate the measurement unit, and then the sample liquid holding unit is filled with the sample, Wait until the sample liquid is detected by the liquid detection unit, and when the sample liquid is detected by the sample liquid detection unit, open the valve and operate the sample liquid supply means operating device to hold it in the sample liquid holding unit. Since the control device is configured to control the operation of each device so as to supply at least one component of the sample liquid in the measuring part by supplying the sample liquid to the measuring part, the above-mentioned disposable testing tool In combination with the above, variations in the introduction pressure and the introduction amount of the sample liquid are eliminated, and problems such as exposure of the sample liquid to air and blood cell sedimentation do not occur.

本発明に係る使い捨て検査具の概略上面図である。It is a schematic top view of the disposable inspection tool which concerns on this invention. 本発明に係る分析装置の概略斜視図である。It is a schematic perspective view of the analyzer according to the present invention. 分析装置の内部構成を示す概略ブロック図である。It is a schematic block diagram which shows the internal structure of an analyzer. 使い捨て検査具における校正液及び検体液の流れを示す図である。It is a figure which shows the flow of the calibration liquid and sample liquid in a disposable inspection tool. 使い捨て検査具における校正液及び検体液の流れを示す図である。It is a figure which shows the flow of the calibration liquid and sample liquid in a disposable inspection tool. 使い捨て検査具における校正液及び検体液の流れを示す図である。It is a figure which shows the flow of the calibration liquid and sample liquid in a disposable inspection tool.

以下、添付図面に示した一実施例を参照して本発明に係る使い捨て検査具及び分析装置の実施の形態を説明していく。 Embodiments of a disposable testing tool and an analyzer according to the present invention will be described below with reference to an embodiment shown in the accompanying drawings.

図1は、本発明に係る使い捨て検査具Aの概略上面図である。 FIG. 1 is a schematic top view of a disposable inspection tool A according to the present invention.

この実施例では、使い捨て検査具A(以下、単に「検査具A」と称します。)は、透明又は半透明のプラスチック材料等の適当な材料から成るハウジング1を有する。 In this embodiment, a disposable inspection tool A (hereinafter, simply referred to as “inspection tool A”) has a housing 1 made of a suitable material such as a transparent or translucent plastic material.

ハウジング1の内部には、検体液通路2が形成されている。 A sample liquid passage 2 is formed inside the housing 1.

ハウジング1における検体液通路2の上流端には上向き(図1における紙面手前)に開口して成る検体液導入部3が形成されており、検体液通路2の下流端は廃液溜め4に接続されている。廃液溜め4には、空気孔4aが形成されている。 At the upstream end of the sample liquid passage 2 in the housing 1, there is formed a sample liquid introducing section 3 that opens upward (toward the front of the paper in FIG. 1), and the downstream end of the sample liquid passage 2 is connected to a waste liquid reservoir 4. ing. An air hole 4a is formed in the waste liquid reservoir 4.

図中、符号5は計測部を示している。この計測部5は、絶縁性基板上に導電性インキを塗布して形成された複数の電極部5aを備えている。これらの電極部5aは、検体液通路2における検体液導入部3及び廃液溜め部4の間に位置するように配置されており、検体液通路2に供給される検体液が各電極部5aと接触するように構成されている。 In the figure, reference numeral 5 indicates a measuring unit. The measuring unit 5 includes a plurality of electrode units 5a formed by applying a conductive ink on an insulating substrate. These electrode parts 5a are arranged so as to be located between the sample liquid introducing part 3 and the waste liquid reservoir part 4 in the sample liquid passage 2, so that the sample liquid supplied to the sample liquid passage 2 is connected to the respective electrode parts 5a. Configured to contact.

各電極部5aには、例えば、酸性度pH、炭酸ガス分圧PCO2、酸素分圧PO2、ナトリウムNa、カリウムK、塩素Cl、イオン化カルシウムCa、尿素窒素BUN、グルコースGlu、ヘマトクリットHct等のような計測すべき成分に応じて、計測すべきガス成分が透過可能なガス透過膜や、計測すべきそのほかの成分には反応する化学物質や天然物質を塗布してなる試薬層等が適宜設けられ得る。これにより、検体液通路2における電極部5aに対応する位置に検体が送り込まれると、各電極部5aを介して検体の成分が計測される。
また、前記計測部5は、例えば、検体としての血液中の酸素分圧やグルコース濃度を測定するために電流計測方式が用いられる場合にはさらに対極を備える。また、前記計測部5は、検体中の水素、ナトリウム又はカリウム等のイオン濃度を測定するために電位差計測方式が用いられる場合には、さらに参照電極を有する。さらにまた、ヘマトクリット量を測定するために検体中の電導度を測定する場合には、電極間に交流電圧を印加できるように構成され得る。
また、計測部5は、前記電極部5aに接続される端子部5bを備え、これらの端子部5bは、ハウジング1の外部に露出するように構成され、検査具Aを後述する分析装置に装着した時に、分析装置の端子に接続される。
For each electrode portion 5a, for example, acidity pH, carbon dioxide partial pressure PCO2, oxygen partial pressure PO2, sodium Na, potassium K, chlorine Cl, ionized calcium Ca, urea nitrogen BUN, glucose Glu, hematocrit Hct, etc. Depending on the component to be measured, a gas permeable membrane through which the gas component to be measured can permeate, and other components to be measured may be appropriately provided with a reagent layer formed by applying a reacting chemical substance or natural substance. .. As a result, when the sample is sent to the position corresponding to the electrode part 5a in the sample liquid passage 2, the component of the sample is measured via each electrode part 5a.
The measuring unit 5 further includes a counter electrode when a current measuring method is used to measure the oxygen partial pressure or glucose concentration in blood as a sample, for example. The measuring unit 5 further includes a reference electrode when a potentiometric measurement method is used to measure the ion concentration of hydrogen, sodium, potassium or the like in the sample. Furthermore, when measuring the electrical conductivity in the sample to measure the hematocrit amount, an alternating voltage can be applied between the electrodes.
Further, the measuring unit 5 includes terminal portions 5b connected to the electrode portion 5a, and these terminal portions 5b are configured to be exposed to the outside of the housing 1, and the inspection tool A is attached to an analyzer described later. Then, it is connected to the terminal of the analyzer.

上記したように構成された検体液通路2における検体液導入部3と計測部5との間には、バルブ7が設けられている。このバルブ7は、分析装置によって開閉できるように構成されていれば任意でよいが、例えば、ハウジング1のバルブ7に相当する部分を分析装置に設けられたピストンで押圧することにより変形させて検体液通路2を塞ぐことにより閉弁し、ピストンを引き上げることにより変形した部分が元の形状に復元して検体液通路2を開通して開弁するように構成され得る。このように構成する場合、バルブ7は未使用時には開弁状態にある。前記バルブ7は、前記構成に限定されることなく、任意の適当なバルブであり得、例えば、電磁弁であってもよく、又は、機械式弁であってもよい。 A valve 7 is provided between the sample liquid introducing section 3 and the measuring section 5 in the sample liquid passage 2 configured as described above. The valve 7 may be of any type as long as it can be opened and closed by the analyzer. For example, a portion of the housing 1 corresponding to the valve 7 is deformed by pressing a piston provided in the analyzer to deform the sample. The liquid passage 2 may be closed by closing the valve, and the portion deformed by pulling up the piston may be restored to its original shape to open the sample liquid passage 2 and open the valve. With this configuration, the valve 7 is in the open state when not in use. The valve 7 is not limited to the above configuration, and may be any appropriate valve, for example, a solenoid valve or a mechanical valve.

検体液通路部2における前記バルブ7と検体液導入部3との間には、検体液保持部11が形成されており、該検体液保持部11とバルブ7との間には分岐通路10が設けられている。この分岐通路10には、小径に広がる検体液検出部13が形成されており、この検体液検出部13の下流には検体液溜め12が形成され、さらに、この検体液溜め12の下流には、検体は通さないが、空気は通す栓が設けられた空気出口19が設けられ、該空気出口19には自動空気抜き弁が設けられている。前記空気出口19に設けられた自動空気抜き弁は、本実施例では、分析装置によって閉弁することができるように構成されている。 A sample liquid holding portion 11 is formed between the valve 7 and the sample liquid introducing portion 3 in the sample liquid passage portion 2, and a branch passage 10 is formed between the sample liquid holding portion 11 and the valve 7. It is provided. A sample liquid detection part 13 having a small diameter is formed in the branch passage 10, a sample liquid reservoir 12 is formed downstream of the sample liquid detection part 13, and further downstream of the sample liquid reservoir 12. An air outlet 19 is provided with a stopper that allows air to pass through, but does not allow a sample to pass through, and the air outlet 19 is provided with an automatic air vent valve. In this embodiment, the automatic air vent valve provided at the air outlet 19 is configured so that it can be closed by the analyzer.

上記した構成により、バルブ7を閉弁した状態で検体液導入部3から検体液を注入すると、検体液が検体保持部11を通って分岐通路10に入り、検体液検出部13を介して検体液溜め12に流入する。検体液検出部13は、その中の検体液の状態が、後述する分析装置に設けられたセンサで検出され、例えば、このセンサが「検体液検出部13が検体液で満たされたこと」を検出すると、検体液保持部11が満たされたことを視覚的(例えば、文字で表示)又は聴覚的(例えば、ブザーを鳴らす)に操作者に知らせるように分析装置が構成され得る。この検体液検出部13の構成は、本実施例に限定されることなく、例えば、光学的に、或いは電気的に検出することができる。或いは操作者が外部から目視できるように構成されてもよく、カメラでモニタに映してみることもできる。このように、検体液検出部13が検体で満たされるまで検体を注入すると、検体液保持部11が検体で満たされるように構成することで、操作者は、検体液検出部13を見ながら検体液の注入を行うことが可能になる。検体液溜め12は、使用者が検体を入れすぎた時に余分が検体を受け止めるバッファとして機能するものであり、必ずしも検体検出部13と別体に形成する必要はなく、例えば、検体検出部13と一体に形成してもよい。また、この実施例では、分岐通路10に検体液検出部13を設けているが、この構成は本実施例に限定されることなく、検体液検出部13は、検体液保持部11が検体で満たされたことを検知可能な位置であれば任意の位置に設けることができ、例えば、分岐通路10ではなく、検体液保持部10とバルブ7との間に配置してもよい。
また、本発明に係る検体液供給手段を構成する空気保持部15が、検体液保持部11と検体導入部3との間に形成された分岐通路14に設けられている。ハウジング1の上面及び/下面における前記空気保持部15に対応する部分は、変形可能な厚さにされており、後述する分析装置に設けられたプッシャーによって押圧することにより空気保持部15を圧縮し、内部の空気を押し出すことができるように構成されている。これにより、バルブ7が開弁している時に、分析装置に設けられたプッシャーでハウジング1の空気保持部15に対応する部分を押圧することで、空気保持部15を圧縮して空気を押し出して、検体液保持部2に保持された検体を計測部5へ押し出すことができる。
With the above configuration, when the sample liquid is injected from the sample liquid introducing unit 3 with the valve 7 closed, the sample liquid passes through the sample holding unit 11 and enters the branch passage 10, and the sample liquid is detected via the sample liquid detecting unit 13. It flows into the liquid reservoir 12. The sample liquid detection unit 13 detects the state of the sample liquid therein by a sensor provided in an analyzer described later, and, for example, this sensor indicates that "the sample liquid detection unit 13 is filled with the sample liquid". Upon detection, the analyzer may be configured to visually (eg, in text) or audibly (eg, sound a buzzer) inform the operator that the sample fluid reservoir 11 has been filled. The configuration of the sample liquid detection unit 13 is not limited to the present embodiment, and can be detected optically or electrically, for example. Alternatively, it may be configured so that the operator can visually check it from the outside, and the image can be viewed on a monitor with a camera. In this way, by injecting the sample until the sample liquid detection unit 13 is filled with the sample, the sample liquid holding unit 11 is filled with the sample, so that the operator can see the sample liquid detection unit 13 while viewing the sample liquid. It becomes possible to inject the liquid. The sample reservoir 12 functions as a buffer that receives the excess sample when the user overfills the sample, and does not necessarily have to be formed separately from the sample detection unit 13. You may form integrally. In addition, in this embodiment, the sample liquid detection unit 13 is provided in the branch passage 10, but this configuration is not limited to this embodiment, and the sample liquid detection unit 13 includes the sample liquid holding unit 11 as the sample. It can be provided at any position as long as it can detect that it is filled, and for example, it may be arranged between the sample liquid holding unit 10 and the valve 7 instead of the branch passage 10.
Further, the air holding portion 15 constituting the sample liquid supply means according to the present invention is provided in the branch passage 14 formed between the sample liquid holding portion 11 and the sample introducing portion 3. A portion of the upper surface and/or the lower surface of the housing 1 corresponding to the air holding portion 15 has a deformable thickness, and the air holding portion 15 is compressed by being pressed by a pusher provided in an analyzer described later. , So that the air inside can be pushed out. As a result, when the valve 7 is open, the pusher provided in the analyzer presses the portion of the housing 1 corresponding to the air holding portion 15 to compress the air holding portion 15 and push out the air. The sample held in the sample liquid holding unit 2 can be pushed out to the measuring unit 5.

検体液通路部2における前記バルブ7と、前記計測部5との間には、校正液用分岐通路21が設けられており、この校正液用分岐通路21の下流端には校正液容器23が設けられている。 A calibration liquid branch passage 21 is provided between the valve 7 and the measurement unit 5 in the sample liquid passage portion 2, and a calibration liquid container 23 is provided at the downstream end of the calibration liquid branch passage 21. It is provided.

校正液容器23は、ガス透過性のない、又は低い材質から成り、内部に各電極部5aの校正用の試薬を密封的に収容している。ハウジング1の上面及び/又は下面における校正液容器23に対応する部分は、変形可能な厚みにされており、後述する分析装置に設けられたプッシャーによって押圧すると変形又は穿刺され校正液容器23から校正用試薬が出てくるように構成されている。これにより、バルブ7が閉弁している時に、分析装置に設けられたプッシャーで校正液容器23を押圧することで、校正液容器23内の校正液が校正液用分岐通路21を介して計測部5へ押し出される。 The calibration liquid container 23 is made of a material having no gas permeability or a low gas permeability, and hermetically houses the calibration reagent for each electrode portion 5a therein. A portion of the upper surface and/or the lower surface of the housing 1 corresponding to the calibration liquid container 23 has a deformable thickness, and is deformed or punctured when pressed by a pusher provided in an analyzer described later to calibrate from the calibration liquid container 23. It is configured so that the reagent for use comes out. As a result, when the valve 7 is closed, the calibration solution container 23 is pressed by the pusher provided in the analyzer so that the calibration solution in the calibration solution container 23 is measured via the calibration solution branch passage 21. Extruded to part 5.

次に、上記したように構成された使い捨て検査具Aを使用する分析装置30の構成について簡単に説明をしていく。 Next, the configuration of the analyzer 30 that uses the disposable inspection tool A configured as described above will be briefly described.

図2は分析装置30の概略斜視図を、図3は分析装置30の概略ブロック図を各々示している。 2 shows a schematic perspective view of the analyzer 30, and FIG. 3 shows a schematic block diagram of the analyzer 30.

図2において、符号31は検査具Aを挿入することができるように構成された検査具装着部を、符号32は入力インターフェイスを兼ねたモニタを各々示している。 In FIG. 2, reference numeral 31 denotes a test tool mounting portion configured so that the test tool A can be inserted, and reference numeral 32 denotes a monitor that also serves as an input interface.

分析装置30は、その内部に、検査具Aにおける計測部5の端子部5bと接続可能な端子35、検査具Aの検体液検出部13における検体液の有無を検出可能なセンサ37、検体液保持部2に保持された検体を押し出すために空気保持部15を押圧するプッシャー39、校正液容器23を押圧するプッシャー41、検査具Aのバルブ7を開閉するバルブ作動装置43、並びに、プッシャー39、41及びバルブ作動装置43の動作を制御し、かつ、端子35からの入力信号に基づいて電極部5aの校正及び検体液内の成分の測定・分析を行う制御装置47を備えている。制御装置47には、モニタ32に表示される各種操作ボタンからの信号も入力され得る。 The analyzer 30 has therein a terminal 35 connectable to the terminal portion 5b of the measuring unit 5 of the inspection tool A, a sensor 37 capable of detecting the presence or absence of the sample liquid in the sample liquid detection unit 13 of the inspection tool A, and a sample liquid. The pusher 39 that presses the air holding unit 15 to push out the sample held in the holding unit 2, the pusher 41 that presses the calibration liquid container 23, the valve operating device 43 that opens and closes the valve 7 of the inspection tool A, and the pusher 39. , 41 and the valve actuator 43, and a controller 47 for calibrating the electrode part 5a and measuring/analyzing the components in the sample liquid based on the input signal from the terminal 35. Signals from various operation buttons displayed on the monitor 32 may also be input to the control device 47.

以下に、上記したように構成された使い捨て検査具A及び分析装置30を用いて、検体液の分析を行う工程について説明していく。 The process of analyzing the sample liquid using the disposable test tool A and the analyzer 30 configured as described above will be described below.

未使用状態において検査具Aのバルブ7は開弁状態にある。 In the unused state, the valve 7 of the inspection tool A is open.

操作者が検査具Aを分析装置30にセットすると、制御装置47は、バルブ作動装置43を介してバルブ7が閉弁状態にあることを確認して、開弁している場合には閉弁し、プッシャー41を作動すると共に、モニタ32に「校正中」であることを表示する。 When the operator sets the inspection tool A in the analyzer 30, the control device 47 confirms that the valve 7 is in the closed state via the valve operating device 43, and if the valve is open, the control device 47 closes the valve. Then, the pusher 41 is operated and the monitor 32 displays that “calibration is in progress”.

図4(a)に示すようにプッシャー41によって押圧されると校正液容器23から校正液が押し出され、校正液が計測部5の電極部5aに送られる。校正液が電極部5aに到達すると、制御装置47は各電極部5aに対する校正を行う。 As shown in FIG. 4A, when pushed by the pusher 41, the calibration liquid is pushed out from the calibration liquid container 23, and the calibration liquid is sent to the electrode portion 5 a of the measuring unit 5. When the calibration liquid reaches the electrode portions 5a, the controller 47 calibrates each electrode portion 5a.

制御装置47は、校正が終了すると、モニタ32に、校正が終了したことを表示すると共に、シリンジ等の検体採取具によって検体液を検体液導入部3から注入するよう指示をする表示をする。 When the calibration is completed, the control device 47 displays on the monitor 32 that the calibration is completed, and also displays an instruction to inject the sample liquid from the sample liquid introducing unit 3 by the sample collecting tool such as a syringe.

操作者が、シリンジ等によって検体液を注入すると、バルブ7が閉弁しているので、検体液は分岐通路10を介して検体液溜め12に向けて送られる。検体検出部13が検体液で満たされると、次いで、検体液溜め12に検体液が入る(図4(b))。 When the operator injects the sample liquid with a syringe or the like, since the valve 7 is closed, the sample liquid is sent toward the sample liquid reservoir 12 via the branch passage 10. When the sample detection unit 13 is filled with the sample liquid, the sample liquid then enters the sample liquid reservoir 12 (FIG. 4B).

制御装置47は、検体液検出部13が検体液で満たされたことをセンサ37が検出すると、モニタ32に、検体液の注入を終了するよう指示する表示をする。これはモニタ32を介した視覚的表示に限定されることなく、例えば、ブザー等を用いて聴覚的に表示するように構成してもよいことは勿論である。 When the sensor 37 detects that the sample liquid detection unit 13 is filled with the sample liquid, the control device 47 displays on the monitor 32 an instruction to finish the injection of the sample liquid. It is needless to say that this is not limited to visual display via the monitor 32, and may be configured to be aurally displayed using, for example, a buzzer or the like.

検体液の注入が終了すると、制御装置47はバルブ7を開弁すると共に、空気出口19を閉じ、プッシャー39を動かして、空気保持部15を押圧する。これにより空気保持部15の空気が検体液保持部11上流に押し出され、検体液保持部11から押し出された検体液は、バルブ7が開弁しているので計測部5側に押し流され、計測部5の電極部5aに到達する。この時、電極部5aには校正液が残留しているが、残留していた校正液は、検体液によって廃液溜め4に押し出されることになる(図4(c))。尚、検体の注入は作業者が行うため、必ずしも、検体溜め12が充満するまで検体が注入されているとは限らないが、上記したように分析装置で空気出口19を閉じることにより、空気保持部15を変形して検体を計測部5へ移動するときに、空気が空気出口19から漏れて、検体が計測部5へ行かず分岐通路10側に入ってしまうことがない。 この状態で、制御装置47により、検体液の成分の測定及び分析が行われ、その測定及び分析結果は、モニタ32に表示される。測定及び分析結果は、例えば、分析装置30にプリンタ(図示せず)を設け、プリントアウトできるように構成してもよく、また、不図示のメモリに保存するように構成してもよい。 When the injection of the sample liquid is completed, the control device 47 opens the valve 7, closes the air outlet 19, moves the pusher 39, and presses the air holding portion 15. As a result, the air in the air holding unit 15 is pushed out to the upstream side of the sample liquid holding unit 11, and the sample liquid pushed out of the sample liquid holding unit 11 is swept toward the measurement unit 5 side because the valve 7 is opened, and the measurement is performed. The electrode portion 5a of the portion 5 is reached. At this time, the calibration liquid remains in the electrode portion 5a, but the remaining calibration liquid is pushed out to the waste liquid reservoir 4 by the sample liquid (FIG. 4(c)). Since the operator injects the sample, the sample is not always injected until the sample reservoir 12 is full. However, as described above, the air outlet 19 is closed by the analyzer to retain the air. When the part 15 is deformed to move the sample to the measuring part 5, air does not leak from the air outlet 19 and the sample does not go to the measuring part 5 and enters the branch passage 10 side. In this state, the control device 47 measures and analyzes the components of the sample liquid, and the measurement and analysis results are displayed on the monitor 32. The measurement and analysis results may be configured such that a printer (not shown) is provided in the analysis device 30 so that the measurement and analysis results can be printed out, or can be stored in a memory (not shown).

上記したように、本実施例に係る使い捨て検査具は、検体液保持部2にバルブ7を設けることによって、シリンジ等の検体液採取具から注入される検体液を一度、検体液保持部11に溜めてから、空気圧により計測部5に送り出すように構成されているので、シリンジ等から検体液を注入する時の注入圧力や注入量のバラツキが生じない。また、校正が終了した後に、シリンジ等の検体液採取具から検体液を注入することができるようになるため、検体液は測定直前まで検体液採取具内に収容されていることになる。また、シリンジを使い捨て検査具の検体液導入部3にセットする直前に攪拌することもできる。このため、検体液の空気暴露や血球沈降等の問題を最小限に抑えることができる。 As described above, in the disposable testing tool according to the present embodiment, by providing the sample liquid holding part 2 with the valve 7, the sample liquid injected from the sample liquid collecting tool such as a syringe is once stored in the sample liquid holding part 11. Since it is configured to be sent out to the measurement unit 5 by air pressure after being stored, there is no variation in injection pressure or injection amount when the sample liquid is injected from a syringe or the like. Further, since the sample liquid can be injected from the sample liquid collecting tool such as a syringe after the calibration is completed, the sample liquid is stored in the sample liquid collecting tool until immediately before the measurement. It is also possible to stir immediately before setting the syringe in the sample liquid introducing section 3 of the disposable inspection tool. Therefore, problems such as exposure of the sample liquid to the air and blood cell sedimentation can be minimized.

上記した実施例では、分析装置側に検体液検出部13が検体で満たされたことを検出するセンサを設け、検体液検出部13が検体で満たされると、自動的に、バルブ7を開弁してプッシャー39を動作させて、空気保持部15押圧し検体液を計測部5に押し出すように構成されているが、この構成は本実施例に限定されることなく、例えば、操作者が外部から目視できるように構成されてもよく、カメラでモニタに映して、操作者が検体液検出部13を見ながら検体液の注入を行い、検体液検出部13が検体液で満たされたら注入を止めるように構成してもよい。制御装置47により自動検出した場合は、制御装置47がバルブ7を開弁して、プッシャー39を動作させるように構成され得る。また、操作者が目視観察により検体注入を行った場合は、モニタ32に測定開始ボタンを設け、操作者が検体液注入後に測定開始ボタンを押すと、制御装置47がバルブ7を開弁して、プッシャー39を動作させるように構成され得る。または前記二つの方法を融合して構成してもよい。 In the embodiment described above, a sensor for detecting that the sample liquid detection unit 13 is filled with the sample is provided on the analyzer side, and when the sample liquid detection unit 13 is filled with the sample, the valve 7 is automatically opened. Then, the pusher 39 is operated to push the air holding unit 15 to push out the sample liquid to the measuring unit 5. However, this configuration is not limited to this embodiment, and for example, the operator may It may be configured so that it can be viewed from the inside, and the operator injects the sample liquid while viewing it on the monitor with the camera and looking at the sample liquid detection unit 13. When the sample liquid detection unit 13 is filled with the sample liquid, It may be configured to stop. When automatically detected by the control device 47, the control device 47 may be configured to open the valve 7 and operate the pusher 39. When the operator injects the sample by visual observation, the monitor 32 is provided with a measurement start button, and when the operator presses the measurement start button after injecting the sample liquid, the control device 47 opens the valve 7. , Pusher 39 may be configured to operate. Alternatively, the above two methods may be combined.

また、本実施例では、検体液供給手段として、空気保持部を設け、該空気保持部をプッシャーで押圧することで検体液を計測部に送るように構成されているが、検体液供給手段の構成は本実施例に限定されることなく、例えば、分析装置にポンプを設け、検査具に該ポンプと接続可能な接続部を設け、ポンプから供給される空気によって検体液を検体液保持部から計測部に供給するように構成してもよい。 Further, in the present embodiment, as the sample liquid supply means, an air holding part is provided, and the sample liquid is sent to the measuring part by pressing the air holding part with a pusher. The configuration is not limited to this example, and for example, a pump is provided in the analyzer, a connection part that can be connected to the pump is provided in the inspection tool, and the sample liquid is supplied from the sample liquid holding part by the air supplied from the pump. You may comprise so that it may supply to a measuring part.

なお、ハウジング1の構成は、様々な構成が考えられるが、例えば、特開平11−83783号公報に開示されているように、二枚のハウジング片を、それらの間に仕切板を挟んで重ねて結合することで構成され得る。 Various configurations can be considered for the configuration of the housing 1. For example, as disclosed in Japanese Patent Laid-Open No. 11-37883, two housing pieces are superposed with a partition plate interposed therebetween. It can be configured by combining.

A 検査具
1 ハウジング
2 検体液通路
3 検体液導入部
4 廃液溜め部
4a 空気孔
5 計測部
5a 電極部
5b 端子部
7 バルブ
10 分岐通路
11 検体液保持部
12 検体液溜め
13 検体液検出部
14 分岐通路
15 空気保持部
19 空気出口

21 校正液用分岐流路
23 校正液容器

30 分析装置
31 検査具装着部
32 モニタ
35 端子(計測信号入力部)
37 センサ
39 プッシャー(検体液供給手段作動装置)
41 プッシャー(校正液供給手段作動装置)
43 バルブ作動装置
47 制御装置
A inspection tool 1 housing 2 sample liquid passage 3 sample liquid introduction part 4 waste liquid storage part 4a air hole 5 measurement part 5a electrode part 5b terminal part 7 valve 10 branch passage 11 sample liquid holding part 12 sample liquid storage part 14 sample liquid detection part 14 Branch passage 15 Air holding part 19 Air outlet

21 Branch Flow Path for Calibration Solution 23 Calibration Solution Container

30 Analytical device 31 Inspection tool mounting section 32 Monitor 35 terminal (measurement signal input section)
37 sensor 39 pusher (sample liquid supply means operation device)
41 Pusher (calibration liquid supply means operating device)
43 valve actuation device 47 control device

Claims (5)

ハウジング(1)の内部に検体液通路(2)を設け、
前記検体液通路(2)の上流部分に、検体液導入部(3)を設け、下流部分に廃液溜め部(4)を設けると共に、
前記検体液通路(2)における検体液導入部(3)と廃液溜め部(4)との間に、検体液中の少なくとも一つの成分を計測可能な計測部(5)を設け、
前記計測部(5)の計測結果に基づいて検体液中の少なくとも一つの成分を分析装置で分析できるように構成された分析装置用使い捨て検査具において、
前記検体液通路(2)における前記検体液導入部(3)と前記計測部(5)との間に、バルブ(7)を設け、
前記検体液通路(2)における前記検体液導入部(3)と前記バルブ(7)との間に、検体を一時的に保持する検体液保持部(11)と、検体液保持部(11)に保持された検体を前記計測部(5)に向けて押し出す検体液供給手段を設け、
前記検体液通路(2)における前記バルブ(7)と前記計測部(5)との間に、そこから分岐する校正液通路を設け、前記校正液通路に校正液供給手段を設けて成り、
前記バルブ(7)を閉弁した状態で、前記計測部(5)の校正を行い、計測部(5)の校正後に前記検体液導入部(3)から検体液を導入して前記検体液保持部(11)に保持し、次いで、バルブ(7)を開弁して検体液保持部(11)に保持されている検体液を計測部(5)に向けて押し出すことができるように構成されている
ことを特徴とする使い捨て検査具。
The sample liquid passage (2) is provided inside the housing (1),
A sample liquid introduction part (3) is provided in the upstream part of the sample liquid passage (2), and a waste liquid reservoir part (4) is provided in the downstream part,
A measuring unit (5) capable of measuring at least one component in the sample liquid is provided between the sample liquid introducing unit (3) and the waste liquid reservoir (4) in the sample liquid passage (2),
A disposable inspection tool for an analyzer, which is configured to analyze at least one component in a sample liquid on the basis of the measurement result of the measuring unit (5),
A valve (7) is provided between the sample liquid introduction part (3) and the measurement part (5) in the sample liquid passage (2),
A sample liquid holding part (11) for temporarily holding a sample between the sample liquid introducing part (3) and the valve (7) in the sample liquid passage (2), and a sample liquid holding part (11). A sample liquid supply means for pushing the sample held in the direction toward the measuring section (5),
A calibration liquid passage branched from the valve (7) and the measurement unit (5) in the sample liquid passage (2) is provided, and a calibration liquid supply means is provided in the calibration liquid passage.
The measurement unit (5) is calibrated with the valve (7) closed, and a sample liquid is introduced from the sample liquid introduction unit (3) after the measurement unit (5) is calibrated to retain the sample liquid. It is configured such that the sample liquid held in the part (11) and then the valve (7) is opened to push the sample liquid held in the sample liquid holding part (11) toward the measuring part (5). Disposable inspection tool characterized by:
前記検体液供給手段が、前記検体液保持部(11)に接続された空気保持部(15)を備え、
前記空気保持部(15)を加圧することによって、該空気保持部(15)内に保持された空気で、前記検体液保持部(11)内に保持された検体液を計測部(5)まで押し出すように構成されている
ことを特徴とする請求項1に記載の使い捨て検査具。
The sample liquid supply means comprises an air holding part (15) connected to the sample liquid holding part (11),
By pressurizing the air holding part (15), the sample liquid held in the sample liquid holding part (11) is measured by the air held in the air holding part (15) up to the measuring part (5). The disposable testing tool according to claim 1, wherein the disposable testing tool is configured to be pushed out.
前記ハウジング(1)における前記空気保持部(15)に対応する部分を変形可能に構成した
ことを特徴とする請求項2に記載の使い捨て検査具。
The disposable inspection tool according to claim 2, wherein a portion of the housing (1) corresponding to the air holding portion (15) is configured to be deformable.
前記検体液通路(2)における検体液保持部(11)とバルブ(7)との間に、そこから分岐する分岐通路(10)を設け、該分岐通路(10)に検体液保持部(11)が検体液に満たされたことを検出可能な検体液検出部(13)を設けた
ことを特徴とする請求項3に記載の使い捨て検査具。
A branch passage (10) branching from the sample liquid holding portion (11) and the valve (7) in the sample liquid passage (2) is provided, and the sample liquid holding portion (11) is provided in the branch passage (10). 4. The disposable testing tool according to claim 3, further comprising a sample liquid detection section (13) capable of detecting that the sample liquid is filled with the sample liquid.
請求項1〜4の何れか一項に記載の使い捨て検査具を用いて検体液中の少なくとも一つの成分を分析するように構成された分析装置であって、
前記使い捨て検査具を装着可能な検査具装着部(31)と、
前記使い捨て検査具における計測部(5)からの計測信号を入力可能な計測信号入力部(35)と、
前記使い捨て検査具におけるバルブ(7)を開閉するバルブ作動装置(43)と、
前記使い捨て検査具における検体液供給手段を作動する検体液供給手段作動装置(39)と、
前記使い捨て検査具における前記校正液供給手段を作動する校正液供給手段作動装置(41)と、
制御装置(47)とを備え、
検査具装着部(31)に使い捨て検査具が装着されると、バルブ(7)を閉弁した後、前記校正液供給手段作動装置(41)を作動させて校正液を計測部(5)に供給して計測部(5)の校正を実行し、次いで、検体液保持部(11)が検体液で満たされて検体液検出部(13)で検体液を検出するまで待機し、検体液検出部(13)で検体液を検出したら前記バルブ(7)を開弁して、前記検体液供給手段作動装置(39)を作動させて検体液保持部(11)に保持された検体液を計測部(5)に供給して、計測部(5)において検体液の少なくとも一つの成分を計測するように、制御装置(47)が前記各装置の動作を制御するよう構成されている
ことを特徴とする使い捨て検査具用分析装置。
An analysis device configured to analyze at least one component in a sample liquid using the disposable testing tool according to any one of claims 1 to 4,
An inspection tool attachment part (31) to which the disposable inspection tool can be attached,
A measurement signal input unit (35) capable of inputting a measurement signal from the measurement unit (5) of the disposable inspection tool;
A valve actuating device (43) for opening and closing the valve (7) of the disposable inspection tool,
A sample liquid supply means operating device (39) for operating the sample liquid supply means in the disposable inspection tool,
A calibration liquid supply means operating device (41) for operating the calibration liquid supply means in the disposable inspection tool;
And a control device (47),
When the disposable inspection tool is attached to the inspection tool attachment section (31), the valve (7) is closed, and then the calibration solution supply means operating device (41) is operated to transfer the calibration solution to the measurement section (5). Supply and calibrate the measurement unit (5), then wait until the sample liquid holding unit (11) is filled with the sample liquid and the sample liquid detection unit (13) detects the sample liquid. When the sample liquid is detected by the part (13), the valve (7) is opened, the sample liquid supply means operating device (39) is operated, and the sample liquid held in the sample liquid holding part (11) is measured. The control device (47) is configured to control the operation of each device so as to supply at least one component of the sample liquid in the measurement unit (5) by supplying the device to the unit (5). Disposable inspection device analyzer.
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