JP6407468B1 - Blood coagulation time measurement cartridge and blood coagulation time measurement device - Google Patents

Blood coagulation time measurement cartridge and blood coagulation time measurement device Download PDF

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JP6407468B1
JP6407468B1 JP2018100060A JP2018100060A JP6407468B1 JP 6407468 B1 JP6407468 B1 JP 6407468B1 JP 2018100060 A JP2018100060 A JP 2018100060A JP 2018100060 A JP2018100060 A JP 2018100060A JP 6407468 B1 JP6407468 B1 JP 6407468B1
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blood
end side
coagulation time
flow path
measurement channel
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JP2019203827A (en
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満 柏田
満 柏田
啓 高山
啓 高山
康一 芳賀
康一 芳賀
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APEL CO., LTD
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APEL CO., LTD
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Priority to CN202110117155.3A priority patent/CN112946302B/en
Priority to CN201880028634.4A priority patent/CN110573882B/en
Priority to US16/649,000 priority patent/US11543420B2/en
Priority to PCT/JP2018/048528 priority patent/WO2019142650A1/en
Priority to TW108101409A priority patent/TWI691722B/en
Priority to TW108147224A priority patent/TWI705246B/en
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Abstract

【課題】血液を効果的に撹拌させてより短時間で凝固時間が計測できる血液凝固時間測定用カートリッジ、及びこの血液凝固時間測定用カートリッジを使用する血液凝固時間測定装置を提供する。【解決手段】本発明の血液凝固時間測定用カートリッジは、測定流路４の一端側に設けられ、測定流路４に血液を導入する注入口５と、測定流路４の他端側に設けられ、測定流路４の空気又は注入口５から測定流路４に導入された血液を吸引又は加圧可能な連通口８と、測定流路４の所定部分に対して光を透過させることが可能であって、連通口８から測定流路４の空気又は血液を吸引又は加圧するに伴って測定流路４で往復運動する血液が所定部分において存在するか否かが光によって検出される検出エリア２５、２６と、を備え、測定流路４は、少なくとも一部に螺旋状流路２１を有する。【選択図】図４A blood coagulation time measuring cartridge capable of measuring blood coagulation time in a shorter time by effectively stirring blood, and a blood coagulation time measuring apparatus using the blood coagulation time measuring cartridge. A blood coagulation time measurement cartridge according to the present invention is provided on one end side of a measurement channel, and is provided on an inlet port for introducing blood into the measurement channel and on the other end side of the measurement channel. The light can be transmitted to the communication port 8 that can suck or pressurize blood introduced into the measurement channel 4 from the air or the inlet 5 of the measurement channel 4 and a predetermined portion of the measurement channel 4. Detection that is possible and is detected by light whether or not blood that reciprocates in the measurement channel 4 is present in a predetermined portion as air or blood in the measurement channel 4 is sucked or pressurized from the communication port 8 The measurement channel 4 has a spiral channel 21 at least partially. [Selection] Figure 4

Description

本発明は、血液が凝固するまでの時間を計測する際に使用する血液凝固時間測定用カートリッジ、及びこの血液凝固時間測定用カートリッジを使用する血液凝固時間測定装置に関する。   The present invention relates to a blood clotting time measuring cartridge used for measuring the time until blood clots, and a blood clotting time measuring apparatus using the blood clotting time measuring cartridge.

透析や循環器系の手術で行う人工心肺などの体外循環を行う場合、或いは心臓カテーテルの処置を行う場合にあっては、血液の凝固を防ぐために、例えばヘパリンなどの抗凝固剤が使用されている。このような抗凝固剤は、投与量が不足すると体外循環路が閉塞してしまうことがあり、また投与量が過剰であると止血が困難になるため、適切な量で使用することが重要である。従来、このような場合においては、例えば血液に凝固促進剤を混ぜることによって血液の凝固を促進させるとともに、血液が所定の割合で凝固したと判断される時間（血液の凝固時間）を計測することによって、凝固促進剤の投与量や投与する時期を判断する手法が取り入れられており、そのための技術として様々なものが提案されている。   When extracorporeal circulation such as cardiopulmonary bypass is performed by dialysis or circulatory system surgery, or when performing cardiac catheter treatment, an anticoagulant such as heparin is used to prevent blood coagulation. Yes. These anticoagulants may block the extracorporeal circuit if the dosage is insufficient, and it is difficult to stop hemostasis if the dosage is excessive, so it is important to use an appropriate amount. is there. Conventionally, in such a case, blood coagulation is promoted by, for example, mixing a blood coagulation promoter with blood, and the time (blood coagulation time) at which it is determined that the blood has coagulated at a predetermined ratio is measured. Has adopted a technique for determining the dose and timing of administration of a coagulation promoter, and various techniques have been proposed for that purpose.

例えば特許文献１には、直線状に延在するとともに途中に狭窄部分を設けた毛細管を備える測定用カートリッジと、空気ポンプを備える測定装置とからなり、カートリッジを測定装置にセットすることによって空気ポンプをそれぞれの毛細管に接続させ、毛細管に投入した血液を空気ポンプで往復運動させることによって狭窄部分で凝固を促進させ、この往復運動に要する時間の変化から血液の凝固時間を計測する技術が示されている。   For example, Patent Document 1 includes a measurement cartridge including a capillary that extends linearly and has a narrowed portion in the middle thereof, and a measurement device including an air pump. By setting the cartridge in the measurement device, the air pump Is connected to each capillary tube, and the blood injected into the capillary tube is reciprocated by an air pump to promote coagulation in the constricted part, and a technique to measure the blood coagulation time from the change in time required for this reciprocating motion is shown. ing.

米国特許第５３７２９４６号明細書US Pat. No. 5,372,946

ところで、血液の凝固を早めてより短時間で且つ正確に凝固時間を計測するには、血液を効果的に撹拌させることが望ましい。ここで特許文献１のカートリッジでは、血液を往復運動させて流れの向きを切り替えるとともに、狭窄部分を通過させて流れの速度等を変化させることによって血液を撹拌しているが、更に効果的に且つ確実に血液を撹拌させて、より短時間で且つ正確に血液の凝固時間が計測できるカートリッジが求められている。   By the way, in order to accelerate blood coagulation and measure the coagulation time in a shorter time and accurately, it is desirable to stir the blood effectively. Here, in the cartridge of Patent Document 1, the blood is agitated by reciprocating the blood to switch the direction of the flow and changing the flow speed and the like through the narrowed portion. There is a need for a cartridge capable of reliably stirring blood and measuring the coagulation time of blood in a shorter time and accurately.

本発明はこのような問題点を解決することを課題とするものであり、血液を効果的に撹拌させてより短時間で且つ正確に凝固時間が計測できる血液凝固時間測定用カートリッジ、及びこの血液凝固時間測定用カートリッジを使用する血液凝固時間測定装置を提供することを目的とする。   An object of the present invention is to solve such problems, and a blood coagulation time measuring cartridge capable of measuring blood coagulation time in a shorter time and more accurately by effectively stirring blood, and the blood An object of the present invention is to provide a blood coagulation time measuring device using a coagulation time measuring cartridge.

本発明は、血液が収容される測定流路と、前記測定流路の一端側に設けられ、該測定流路に血液を導入する注入口と、前記測定流路の他端側に設けられ、前記測定流路の空気又は前記注入口から該測定流路に導入された血液を吸引又は加圧可能な連通口と、前記測定流路の所定部分に対して光を透過させることが可能であって、前記連通口から該測定流路の空気又は血液を吸引又は加圧するに伴って該測定流路で往復運動する前記血液が該所定部分において存在するか否かが光によって検出される検出エリアと、を備え、前記測定流路は、少なくとも一部に螺旋状流路を有し、前記螺旋状流路は、前記注入口と前記連通口とをつなぐ溝部の壁面と、該溝部に収容されるとともに表面において螺旋状に周回する螺旋状溝部を有する軸状部材の外周面との間で画定されるものであり、前記溝部は、該溝部の壁面から突出し、前記軸状部材を間に挟むとともに前記検出エリアの近傍に位置する一対の凸部を有し、前記凸部の少なくとも一つは、前記軸状部材に面する側と反対側において傾斜面を有する血液凝固時間測定用カートリッジである。 The present invention is provided in a measurement flow path for containing blood, provided on one end side of the measurement flow path, an inlet for introducing blood into the measurement flow path, and provided on the other end side of the measurement flow path, It is possible to transmit light to a communication port that can suck or pressurize blood introduced into the measurement channel from the air or the inlet of the measurement channel and a predetermined portion of the measurement channel. A detection area in which whether or not the blood that reciprocates in the measurement flow path is present in the predetermined portion as the air or blood in the measurement flow path is sucked or pressurized from the communication port is detected by light. When, wherein the measurement flow path, have a spiral flow path at least in part, the spiral flow path, said inlet and said communication opening and the groove wall that connects, it is housed in the groove portion Outside of the shaft-like member having a spiral groove that spirals around the surface. The groove portion protrudes from the wall surface of the groove portion, and has a pair of convex portions sandwiched between the shaft-like members and located in the vicinity of the detection area. At least one of the parts is a blood coagulation time measurement cartridge having an inclined surface on the side opposite to the side facing the shaft-like member .

また本発明は、上述した血液凝固時間測定用カートリッジをセットする血液凝固時間測定装置であって、前記検出エリアに対応する位置に設けられ、光によって前記血液を検出可能な検出手段を備えるものでもある。   The present invention is also a blood coagulation time measuring device for setting the above-described blood coagulation time measuring cartridge, comprising a detection means provided at a position corresponding to the detection area and capable of detecting the blood by light. is there.

本発明の血液凝固時間測定用カートリッジにおいて、血液が収容される測定流路は、少なくとも一部に螺旋状流路を有するものである。すなわち、螺旋状流路を通過させることで血液を効果的に且つ確実に撹拌させることができるため、血液の凝固時間をより短い時間で且つ正確に計測することができる。また螺旋状流路によって、カートリッジの長手方向の長さは変えることなく測定流路の流路長を長くすることができる効果も得られる（測定流路の流路長はそのままでカートリッジの長手方向の長さを短くできる効果が得られるようにしてもよいし、両効果を組み合わせてもよい）。   In the blood coagulation time measurement cartridge of the present invention, the measurement flow path in which the blood is stored has a spiral flow path at least in part. That is, since blood can be stirred effectively and reliably by passing through the spiral flow path, the blood coagulation time can be accurately measured in a shorter time. In addition, the spiral channel can also increase the length of the measurement channel without changing the length of the cartridge in the longitudinal direction (the length of the measurement channel remains the same in the longitudinal direction of the cartridge). The effect of shortening the length may be obtained, or both effects may be combined).

螺旋状流路は種々の構成で形成することが可能であるが、注入口と前記連通口とをつなぐ溝部と、この溝部に収容されるとともに表面において螺旋状に周回する螺旋状溝部を有する軸状部材と、を備え、溝部の壁面と軸状部材の外周面との間で螺旋状流路が画定されるようにする場合は、より簡易に且つ安価に構成することができる。また、血液の凝固を検出するには、凝固し始めて粘度が上がった血液が通りにくくなるように、螺旋状流路の通路の高さ及び幅はできるだけ狭めることが好ましく、このように軸状部材を溝部に配置する構成を採用することによって、旋状流路の通路高さ及び幅を高い寸法精度で狭めることができるため、血液の凝固時間の計測をより早く且つ安定的に行うことができる。   The spiral flow path can be formed in various configurations, and a shaft having a groove that connects the injection port and the communication port, and a spiral groove that is accommodated in the groove and spirals around the surface. When the spiral flow path is defined between the wall surface of the groove and the outer peripheral surface of the shaft-like member, it can be configured more easily and inexpensively. Further, in order to detect blood coagulation, it is preferable to reduce the height and width of the spiral flow path as much as possible so that blood that has started to coagulate and whose viscosity has increased is difficult to pass. Since the passage height and width of the spiral flow passage can be narrowed with high dimensional accuracy by adopting the configuration in which the groove is disposed in the groove portion, blood clotting time can be measured more quickly and stably. .

また溝部に、この溝部の壁面から突出し、軸状部材を間に挟むとともに検出エリアの近傍に位置する一対の凸部を設ける場合は、軸状部材を所定の位置に収めることができるとともに、凸部によって測定流路が狭められた部分（狭窄部）では、粘度が上がった血液は通りにくくなるため、検出エリアにおいて血液の有無を安定的に検出することができる。そして凸部の少なくとも一つに、軸状部材に面する側と反対側において傾斜面を設ける場合は、血液が狭窄部を通過する際、気泡を巻き込みにくくなるため、気泡による誤検知が抑制されて、検出エリアで血液の有無を検出する精度をより安定させることができる。   In addition, when the groove portion is provided with a pair of convex portions that protrude from the wall surface of the groove portion and sandwich the shaft-shaped member therebetween and is positioned in the vicinity of the detection area, the shaft-shaped member can be accommodated in a predetermined position and In the portion where the measurement channel is narrowed by the portion (stenosis portion), the blood with increased viscosity becomes difficult to pass, and thus the presence or absence of blood can be stably detected in the detection area. If an inclined surface is provided on at least one of the convex portions on the side opposite to the side facing the shaft-shaped member, it is difficult for blood to be involved when blood passes through the constricted portion, so that erroneous detection due to air bubbles is suppressed. Thus, the accuracy of detecting the presence or absence of blood in the detection area can be further stabilized.

本発明に従う血液凝固時間測定用カートリッジの一実施形態を示す斜視図である。It is a perspective view which shows one Embodiment of the cartridge for blood coagulation time measurement according to this invention. 図１に示す血液凝固時間測定用カートリッジに関し、（ａ）は平面図であり、（ｂ）は正面図であり、（ｃ）は右側面図である。1A is a plan view, FIG. 1B is a front view, and FIG. 1C is a right side view of the cartridge for measuring blood coagulation time shown in FIG. 図１に示す血液凝固時間測定用カートリッジに関し、（ａ）は、図２（ａ）に示すＡ−Ａに沿う断面図であり、（ｂ）は底面図である。In relation to the blood coagulation time measurement cartridge shown in FIG. 1, (a) is a cross-sectional view along AA shown in FIG. 2 (a), and (b) is a bottom view. （ａ）は図３におけるＢ部の部分拡大断面図であり、（ｂ）は図３におけるＣ部の部分拡大断面図である。(A) is the elements on larger scale of the B section in FIG. 3, (b) is the elements on larger scale of the C section in FIG.

以下、添付図面を参照しながら本発明に従う血液凝固時間測定用カートリッジ（以下、「カートリッジ」と称する）の一実施形態について説明する。   Hereinafter, an embodiment of a blood coagulation time measuring cartridge (hereinafter referred to as “cartridge”) according to the present invention will be described with reference to the accompanying drawings.

本実施形態のカートリッジは、全体として扁平状になるベース１と、ベース１の底面側でベース１に固着される薄板状の閉塞板２を備えている。   The cartridge according to the present embodiment includes a base 1 that is flat as a whole and a thin plate-like closing plate 2 that is fixed to the base 1 on the bottom surface side of the base 1.

ベース１は、無色透明の合成樹脂で形成されている。なお合成樹脂に限られず、ガラス等で形成してもよい。また無色透明に限られず、少なくとも後述する検出エリアで光が透過する有色透明であってもよい。また検出エリア以外は透明でなくてもよい。また閉塞板２は、無色透明の合成樹脂（薄いシート）で形成されているが、ベース１と同様に、本発明の機能を満たす限りにおいて種々の素材や色で形成することが可能である。またベース１と閉塞板２との結合は、粘着性のもので貼着させても良いし、例えば超音波を使って溶着させてもよい。   The base 1 is made of a colorless and transparent synthetic resin. In addition, it is not restricted to a synthetic resin, You may form with glass etc. Moreover, it is not limited to colorless and transparent, and may be colored and transparent that allows light to pass through at least a detection area described later. Further, the area other than the detection area may not be transparent. The blocking plate 2 is formed of a colorless and transparent synthetic resin (thin sheet). However, as with the base 1, it can be formed of various materials and colors as long as the function of the present invention is satisfied. The base 1 and the closing plate 2 may be bonded with an adhesive, or may be welded using, for example, ultrasonic waves.

ベース１の底面には、図３に示すように断面積に対して長く延在する溝部３が設けられていて、溝部３と閉塞板２との間には、後述するように血液が収容される測定流路４が形成されている。   As shown in FIG. 3, a groove 3 extending long with respect to the cross-sectional area is provided on the bottom surface of the base 1, and blood is accommodated between the groove 3 and the closing plate 2 as described later. The measurement flow path 4 is formed.

そして測定流路４の一端側には、血液を導入可能な注入口５が設けられている。注入口５は、外周面が円柱状をなすとともに内周面が円錐状に設けられた開口部６とつながっている。また開口部６の径方向外側には、円環状をなす余剰血液受け部７が設けられている。   An inlet 5 through which blood can be introduced is provided on one end side of the measurement channel 4. The injection port 5 is connected to an opening 6 having an outer peripheral surface having a columnar shape and an inner peripheral surface having a conical shape. Further, an extra blood receiving portion 7 having an annular shape is provided on the outer side in the radial direction of the opening 6.

また測定流路４の他端側には、連通口８が設けられている。連通口８は、後述するダイヤフラムへの押し込み量を変えることによって、測定流路４内の空気や注入口５から測定流路４に導入された血液を、吸引又は加圧することが可能である。   A communication port 8 is provided on the other end side of the measurement channel 4. The communication port 8 can suck or pressurize the air in the measurement channel 4 or the blood introduced into the measurement channel 4 from the injection port 5 by changing the amount of pushing into the diaphragm described later.

そして測定流路４の中央部分には、底面側に突出するようにして設けられた一対の凸部（一端側凸部９と他端側凸部１０）が設けられていて、これらによって、図４（ａ）の拡大図に示すように測定流路４を狭めた狭窄部（一端側狭窄部１１、他端側狭窄部１２）を形成している。また一端側凸部９において、他端側凸部１０が位置する側と反対側には、傾斜面（一端側傾斜面１３）が設けられている。同様に、他端側凸部１０において、一端側凸部９が位置する側と反対側には、傾斜面（他端側傾斜面１４）が設けられている。   The central portion of the measurement channel 4 is provided with a pair of convex portions (one convex portion 9 and the other convex portion 10) provided so as to protrude toward the bottom surface. As shown in the enlarged view of FIG. 4 (a), narrowed portions (one-side narrowed portion 11 and the other-end narrowed portion 12) are formed by narrowing the measurement flow path 4. Moreover, in the one end side convex part 9, the inclined surface (one end side inclined surface 13) is provided in the opposite side to the side in which the other end side convex part 10 is located. Similarly, in the other end side convex part 10, the inclined surface (other end side inclined surface 14) is provided in the opposite side to the side where the one end side convex part 9 is located.

ベース１は、上述した開口部６や余剰血液受け部７の反対側において、全体的に円筒状になる筒状壁１５を備えている（図３（ａ）参照）。筒状壁１５の内周面は、底面側が小径であって、拡径する部位を挟んで天面側が大径になる形状をなしている。そして筒状壁１５の内側空間は、底面側において連通口８と接続している。なお本実施形態では、筒状壁１５の内側空間全体を空気室１６と称する。   The base 1 includes a cylindrical wall 15 that is entirely cylindrical on the opposite side of the opening 6 and the excess blood receiving portion 7 described above (see FIG. 3A). The inner peripheral surface of the cylindrical wall 15 has a shape in which the bottom surface side has a small diameter and the top surface side has a large diameter across a diameter-enlarging portion. The inner space of the cylindrical wall 15 is connected to the communication port 8 on the bottom surface side. In the present embodiment, the entire inner space of the cylindrical wall 15 is referred to as an air chamber 16.

筒状壁１５の天面側には、空気室１６を閉鎖するダイヤフラム１７が設けられている。ダイヤフラム１７は、例えば厚みが薄く弾性を有するゴムなどで形成されている。また筒状壁１５の径方向外側には、筒状壁１５を挿通させて筒状壁１５に嵌合保持されるとともに、筒状壁１５との間でダイヤフラム１７を挟持する環状のホルダー１８が設けられている。ここで、ダイヤフラム１７を底面側に向けて押し込むと、空気室１６の容積が小さくなるため、空気室１６を加圧することができる。また初期状態においてダイヤフラム１７を底面側に向けて押し込んでおけば、押し込みを緩めることによって空気室１６の容積が大きくなるため、空気室１６を減圧することができる。なお、ダイヤフラム１７を天面側に向けて引き上げることによって、空気室１６を減圧してもよい。   A diaphragm 17 that closes the air chamber 16 is provided on the top surface side of the cylindrical wall 15. The diaphragm 17 is made of, for example, rubber having a small thickness and elasticity. Further, an annular holder 18 that is inserted and held in the cylindrical wall 15 through the cylindrical wall 15 and that sandwiches the diaphragm 17 between the cylindrical wall 15 is provided outside the cylindrical wall 15 in the radial direction. Is provided. Here, when the diaphragm 17 is pushed toward the bottom surface, the volume of the air chamber 16 is reduced, so that the air chamber 16 can be pressurized. In addition, if the diaphragm 17 is pushed toward the bottom surface in the initial state, the volume of the air chamber 16 is increased by loosening the push, so that the air chamber 16 can be decompressed. Note that the air chamber 16 may be decompressed by pulling up the diaphragm 17 toward the top surface.

そして溝部３の内側において、一端側凸部９と他端側凸部１０の間には、軸状部材１９が収容されている。軸状部材１９の外径は、測定流路４の内径と略同じか若干小さい程度であり、また軸状部材１９の全長は、一端側凸部９から他端側凸部１０に至る間隔と略同じか若干小さい程度である。このため軸状部材１９は、溝部３で殆ど移動することはない。そして軸状部材１９の表面には、図４（ａ）の部分拡大図に示すように、螺旋状に周回する螺旋状溝部２０が設けられている。これにより、溝部３及び閉塞板２の壁面と軸状部材１９の外周面との間には、螺旋状流路２１が形成される。ここで本実施形態の軸状部材１９は、雄ねじ（例えばＭ１の雄ねじ）を利用して形成されている。このため軸状部材１９を安価に形成することができる。   A shaft-like member 19 is accommodated between the one end side convex portion 9 and the other end side convex portion 10 inside the groove portion 3. The outer diameter of the shaft-shaped member 19 is substantially the same as or slightly smaller than the inner diameter of the measurement flow path 4, and the total length of the shaft-shaped member 19 is the distance from the one end side convex portion 9 to the other end side convex portion 10. About the same or slightly smaller. For this reason, the shaft-shaped member 19 hardly moves in the groove portion 3. Then, on the surface of the shaft-shaped member 19, as shown in a partially enlarged view of FIG. 4A, a spiral groove 20 that spirals around is provided. Thereby, a spiral flow path 21 is formed between the wall surface of the groove 3 and the closing plate 2 and the outer peripheral surface of the shaft-shaped member 19. Here, the shaft-shaped member 19 of the present embodiment is formed using a male screw (for example, an M1 male screw). For this reason, the shaft-shaped member 19 can be formed at low cost.

ところで、螺旋状流路２１を含む測定流路４において、これらの流路を画定する溝部３の壁面には、血液の凝固を促進させる凝固促進剤が塗布されている。なお凝固促進剤は、測定流路４に面する閉塞板２の壁面に塗布してもよいし、軸状部材１９の外周面に塗布してもよい。   By the way, in the measurement channel 4 including the spiral channel 21, a coagulation promoter that promotes blood coagulation is applied to the wall surface of the groove portion 3 that defines these channels. The coagulation accelerator may be applied to the wall surface of the blocking plate 2 facing the measurement channel 4 or may be applied to the outer peripheral surface of the shaft-shaped member 19.

またベース１の天面には、図１、図２に示すように、ベース１の外縁部に位置するとともにホルダー１８を取り囲んで平面視においてコ字状をなす外縁壁２２が設けられている。また、外縁壁２２の幅方向内側には、一対の内側側壁２３が設けられている。更に、余剰血液受け部７とホルダー１８の間には、一対の内側側壁２３をつなぐ板状部（遮蔽部）２４が設けられている。   As shown in FIGS. 1 and 2, the top surface of the base 1 is provided with an outer edge wall 22 which is located at the outer edge of the base 1 and surrounds the holder 18 and has a U shape in plan view. A pair of inner side walls 23 are provided on the inner side in the width direction of the outer edge wall 22. Further, a plate-like part (shielding part) 24 that connects the pair of inner side walls 23 is provided between the excess blood receiving part 7 and the holder 18.

またベース１と閉塞板２は、測定流路４の所定部分に対して光を透過可能な検出エリアを備えている。本実施形態においては、図３（ａ）に示すように、一端側凸部９の近傍であって注入口５側に位置する一端側検出エリア２５と、他端側凸部１０の近傍であって連通口８側に位置する他端側検出エリア２６とを備えている。なお、一端側検出エリア２５は、遮蔽部２４に対して他端側検出エリア２６寄りに位置している。   Further, the base 1 and the blocking plate 2 are provided with a detection area capable of transmitting light to a predetermined portion of the measurement channel 4. In the present embodiment, as shown in FIG. 3A, in the vicinity of the one end side convex portion 9 and the one end side detection area 25 located on the injection port 5 side and the other end side convex portion 10. And the other end side detection area 26 located on the communication port 8 side. The one end side detection area 25 is located closer to the other end side detection area 26 with respect to the shielding part 24.

このような構成になる本実施形態のカートリッジは、図示を省略する血液凝固時間測定装置（以下、「測定装置」と称する）にセットして血液の凝固時間を測定することが可能である。具体的には、長く延在するカートリッジのダイヤフラム１７が位置する側を測定装置に差し込んで、カートリッジを測定装置にセットする。なお、この状態においては、開口部６は測定装置の外側に位置している。また測定装置には、図３（ａ）に示すように、ダイヤフラム１７を所定の移動量で押し込むことが可能な押圧手段Ｓ１と、光によって血液の有無を検出可能な検出手段が設けられている。本実施形態における検出手段は、一端側検出エリア２５においては測定流路４を挟むように設けられる一端側光源Ｓ２及び一端側受光センサＳ３で構成されていて、他端側検出エリア２６においては、他端側光源Ｓ４及び他端側受光センサＳ５で構成されている。ここで、一端側光源Ｓ２及び他端側光源Ｓ４は赤外線を照射するものであって、一端側受光センサＳ３及び他端側受光センサＳ５は、照射された赤外線を受光するものである。ここで本実施形態の一端側受光センサＳ３及び他端側受光センサＳ５は、照射された赤外線の透過具合によって血液の有無を検知することができるように閾値が最適化されている。なお、一端側光源Ｓ２、一端側受光センサＳ３、他端側光源Ｓ４及び他端側受光センサＳ５の位置は、図示した例とは逆にして、一端側光源Ｓ２と他端側光源Ｓ４をカートリッジの底面側に設け、一端側受光センサＳ３と他端側受光センサＳ５をカートリッジの天面側に設けてもよい。また、このような透過型センサに替えて、反射型センサを使用してもよい。   The cartridge of this embodiment having such a configuration can be set in a blood clotting time measuring device (hereinafter referred to as “measuring device”) (not shown) and measure the blood clotting time. Specifically, the side of the cartridge 17 where the diaphragm 17 is located is inserted into the measuring device, and the cartridge is set in the measuring device. In this state, the opening 6 is located outside the measuring device. Further, as shown in FIG. 3A, the measuring device is provided with a pressing means S1 that can push the diaphragm 17 by a predetermined movement amount and a detecting means that can detect the presence or absence of blood by light. . The detection means in the present embodiment is composed of one end side light source S2 and one end side light receiving sensor S3 provided so as to sandwich the measurement flow path 4 in the one end side detection area 25, and in the other end side detection area 26, The other end side light source S4 and the other end side light receiving sensor S5 are comprised. Here, the one end side light source S2 and the other end side light source S4 emit infrared rays, and the one end side light receiving sensor S3 and the other end side light receiving sensor S5 receive irradiated infrared rays. Here, the threshold values of the one-end light receiving sensor S3 and the other-end light receiving sensor S5 of the present embodiment are optimized so that the presence or absence of blood can be detected based on how the irradiated infrared rays are transmitted. Note that the positions of the one end side light source S2, the one end side light receiving sensor S3, the other end side light source S4, and the other end side light receiving sensor S5 are opposite to the illustrated example, and the one end side light source S2 and the other end side light source S4 are placed in the cartridge. The one end side light receiving sensor S3 and the other end side light receiving sensor S5 may be provided on the top surface side of the cartridge. Further, instead of such a transmission type sensor, a reflection type sensor may be used.

そして、カートリッジを測定装置にセットした後は、測定する血液を分注器などで開口部６の内側に注入する。なお、血液を注入するに際しては、予め押圧手段Ｓ１でダイヤフラム１７を押し込んで空気室１６の容積を減らしておくこととする。ここで、血液の注入量は開口部６からこぼれない程度で十分であるが、血液を多く注入した場合でも、開口部６の径方向外側には余剰血液受け部７が設けられているため、開口部６からこぼれた血液を余剰血液受け部７内に貯めることができる。更に、余剰血液受け部７の外側には、遮蔽部２４が設けられているため、余剰血液受け部７を超えて血液が溢れることがあっても、一端側検出エリア２５や他端側検出エリア２６に流れ込むことはない。   And after setting a cartridge in a measuring apparatus, the blood to measure is inject | poured inside the opening part 6 with a dispenser etc. FIG. When injecting blood, the volume of the air chamber 16 is reduced by pushing the diaphragm 17 with the pressing means S1 in advance. Here, it is sufficient that the amount of blood injected does not spill from the opening 6, but even when a large amount of blood is injected, the excess blood receiving portion 7 is provided on the outer side in the radial direction of the opening 6, Blood spilled from the opening 6 can be stored in the excess blood receiving part 7. Furthermore, since the shielding part 24 is provided outside the surplus blood receiving part 7, even if the blood may overflow beyond the surplus blood receiving part 7, the one end side detection area 25 or the other end side detection area. 26 does not flow.

その後は、押し込んだ押圧手段Ｓ１を引き戻すことによって空気室１６が減圧されるため、連通口８から測定流路４の空気を吸引して、開口部６に注入された血液を測定流路４内に引込むことができる。なお、この状態においては、螺旋状流路２１を通過させて他端側狭窄部１２を超えるまで血液を引込むものとする。他端側狭窄部１２を超えるまで血液が引込まれたか否かは、他端側受光センサＳ５によって血液を検出したか否かによって判断することができる。なお、押圧手段Ｓ１の引き戻し量と引込まれる血液の量には相関性があるため、押圧手段Ｓ１の引き戻し量に基づいて判断するようにしてもよい。また、一端側受光センサＳ３によって血液を検出した時点を押圧手段Ｓ１の引き戻し量の基準とし、そこからの引き戻し量に基づいて他端側狭窄部１２を越えるまで血液を引込むようにしてもよい。   Thereafter, the air chamber 16 is depressurized by pulling back the pressed pressing means S1, so that the air in the measurement channel 4 is sucked from the communication port 8 and the blood injected into the opening 6 enters the measurement channel 4 Can be drawn into. In this state, blood is drawn until it passes through the spiral flow path 21 and exceeds the narrowed portion 12 on the other end side. Whether or not blood has been drawn up to the other end side constriction portion 12 can be determined by whether or not the other end side light receiving sensor S5 has detected blood. Since there is a correlation between the pullback amount of the pressing means S1 and the amount of blood to be drawn, the determination may be made based on the pullback amount of the pressing means S1. Alternatively, the time at which blood is detected by the one end side light receiving sensor S3 may be used as a reference for the pullback amount of the pressing means S1, and the blood may be drawn until the other end side constriction portion 12 is exceeded based on the pullback amount therefrom.

しかる後は、押圧手段Ｓ１を再び押し込むことによって空気室１６を加圧して、測定流路４の血液を一端側狭窄部１１に向けて移動させる。これにより、他端側狭窄部１２に向けて螺旋状流路２１を通過させた血液を、逆向きに移動させることができる。   After that, the air chamber 16 is pressurized by pushing the pressing means S1 again, and the blood in the measurement channel 4 is moved toward the one-end-side constriction portion 11. Thereby, the blood that has passed through the spiral flow path 21 toward the other end side constriction 12 can be moved in the opposite direction.

このようにして押圧手段Ｓ１の押し込みと引戻しを繰り返すことによって、空気室１６を加圧又は減圧することができるため、測定流路４の空気や血液は連通口８を通して加圧又は吸引され、それに伴い、血液を往復運動させることができる。すなわち、流れの向きが切り替わるため、血液を撹拌させることができる。また血液は、一端側狭窄部１１や他端側狭窄部１２を通過する際に流れの速度等が変化するため、この点でも効果的に撹拌される。更に本実施形態においては、螺旋状流路２１を通過させているため、血液をより一層効果的に撹拌させることができる。このようにして血液を撹拌させることによって、溝部３の壁面等に塗布された凝固促進剤を効率的且つ安定的に血液に溶解させることができる。   Since the air chamber 16 can be pressurized or depressurized by repeatedly pushing and pulling the pressing means S1 in this way, air or blood in the measurement channel 4 is pressurized or sucked through the communication port 8, and As a result, blood can be reciprocated. That is, since the flow direction is switched, the blood can be agitated. In addition, since the flow rate of the blood changes when it passes through the one end side constricted portion 11 and the other end side constricted portion 12, the blood is also effectively stirred. Furthermore, in this embodiment, since the spiral flow path 21 is passed, blood can be stirred more effectively. By stirring the blood in this manner, the coagulation promoter applied to the wall surface of the groove 3 can be dissolved in the blood efficiently and stably.

そして、血液が撹拌されて凝固促進剤が溶解すると、血液の粘度は上がっていき、一端側狭窄部１１や他端側狭窄部１２、螺旋状流路２１などでは血液の流れが悪くなる。すなわち、押圧手段Ｓ１の押し込みや引戻しのタイミングは変わらなくても、血液が凝固していない状態での一端側受光センサＳ３及び他端側受光センサＳ５で検知する血液の往復運動の周期と、血液の流れが悪くなったときに一端側受光センサＳ３等で検知される往復運動の周期は変わることになるため、この往復運動に要する時間の変化に基づいて、血液の凝固時間を算出することができる。   When the blood is stirred and the coagulation promoter is dissolved, the viscosity of the blood increases, and the blood flow deteriorates in the one end side constricted portion 11, the other end side constricted portion 12, the spiral channel 21, and the like. That is, the cycle of the reciprocating motion of the blood detected by the one end side light receiving sensor S3 and the other end side light receiving sensor S5 in a state where the blood is not coagulated, even though the pushing and pulling timing of the pressing means S1 does not change, and the blood Since the period of the reciprocating motion detected by the one-end light receiving sensor S3 or the like changes when the flow of the blood goes bad, the blood coagulation time can be calculated based on the change in the time required for the reciprocating motion. it can.

なお、血液が一端側狭窄部１１や他端側狭窄部１２を通過する際、流れの速度等が急激に変化すると、測定流路４の空気を巻き込んで空気の泡ができることがあり、この泡によって一端側受光センサＳ３及び他端側受光センサＳ５での血液の検知に影響が及ぶおそれがある。一方、本実施形態においては、一端側傾斜面１３と他端側傾斜面１４を設けることによって流れの速度等が徐々に変化するようにしている。このため、空気の泡が生じにくくなるため、血液の有無を検出する精度をより安定させることができる。   When blood passes through the one end side constricted portion 11 or the other end side constricted portion 12, if the flow rate or the like changes suddenly, air in the measurement channel 4 may be entrained to form air bubbles. This may affect the detection of blood by the one end side light receiving sensor S3 and the other end side light receiving sensor S5. On the other hand, in the present embodiment, by providing the one end side inclined surface 13 and the other end side inclined surface 14, the flow speed and the like are gradually changed. For this reason, since it becomes difficult to produce the bubble of air, the precision which detects the presence or absence of blood can be stabilized more.

以上、本発明に従うカートリッジ、及び測定装置について具体的な実施形態を示しながら説明したが、本発明に従うカートリッジは、上述した実施形態に限られるものではなく、特許請求の範囲に従う範疇で種々の変更を加えたものも含まれる。例えば本実施形態における螺旋状流路２１は、ベース１に設けた溝部３と、この溝部３に収容される軸状部材１９によって構成したが、ベース１に螺旋状の溝を形成したものでもよい。またダイヤフラム１７の固定方法も種々の手法が採用可能であり、例えば接着剤等を使用してベース１に固着させてもよい。また検出エリアは、一端側及び他端側の何れか一方のみでもよいし、３箇所以上設けてもよい。更に、図３に示すように本実施形態では、注入口５と軸状部材１９の間に一端側検出エリア２５を設け、連通口８と軸状部材１９の間に他端側検出エリア２６を設けたが、両検出エリアは、ともに注入口５と軸状部材１９の間に設けてもよいし、ともに連通口８と軸状部材１９の間に設けてもよい。   The cartridge according to the present invention and the measuring apparatus have been described above with reference to specific embodiments. However, the cartridge according to the present invention is not limited to the above-described embodiments, and various modifications can be made within the scope of the claims. The thing which added is included. For example, the spiral flow path 21 in the present embodiment is configured by the groove portion 3 provided in the base 1 and the shaft-shaped member 19 accommodated in the groove portion 3, but may be one in which a spiral groove is formed in the base 1. . Various methods for fixing the diaphragm 17 may be employed. For example, the diaphragm 17 may be fixed to the base 1 using an adhesive or the like. Further, the detection area may be only one of the one end side and the other end side, or may be provided at three or more locations. Furthermore, as shown in FIG. 3, in the present embodiment, one end side detection area 25 is provided between the inlet 5 and the shaft-shaped member 19, and the other end side detection area 26 is disposed between the communication port 8 and the shaft-shaped member 19. However, both detection areas may be provided between the injection port 5 and the shaft-shaped member 19, or both may be provided between the communication port 8 and the shaft-shaped member 19.

１：ベース
２：閉塞板
３：溝部
４：測定流路
５：注入口
６：開口部
７：余剰血液受け部
８：連通口
９：一端側凸部
１０：他端側凸部
１１：一端側狭窄部
１２：他端側狭窄部
１３：一端側傾斜面
１４：他端側傾斜面
１５：筒状壁
１６：空気室
１７：ダイヤフラム
１８：ホルダー
１９：軸状部材
２０：螺旋状溝部
２１：螺旋状流路
２２：外縁壁
２３：内側側壁
２４：遮蔽部
２５：一端側検出エリア
２６：他端側検出エリア 1: Base 2: Blocking plate 3: Groove portion 4: Measurement flow path 5: Injection port 6: Opening portion 7: Surplus blood receiving portion 8: Communication port 9: One end side convex portion 10: Other end side convex portion 11: One end side Stenosis part 12: other end side constriction part 13: one end side inclined surface 14: other end side inclined surface 15: cylindrical wall 16: air chamber 17: diaphragm 18: holder 19: shaft member 20: spiral groove part 21: spiral Flow path 22: outer edge wall 23: inner side wall 24: shielding part 25: one end side detection area 26: other end side detection area

Claims (2)

血液が収容される測定流路と、
前記測定流路の一端側に設けられ、該測定流路に血液を導入する注入口と、
前記測定流路の他端側に設けられ、前記測定流路の空気又は前記注入口から該測定流路に導入された血液を吸引又は加圧可能な連通口と、
前記測定流路の所定部分に対して光を透過させることが可能であって、前記連通口から該測定流路の空気又は血液を吸引又は加圧するに伴って該測定流路で往復運動する前記血液が該所定部分において存在するか否かが光によって検出される検出エリアと、を備え、
前記測定流路は、少なくとも一部に螺旋状流路を有し、
前記螺旋状流路は、前記注入口と前記連通口とをつなぐ溝部の壁面と、該溝部に収容されるとともに表面において螺旋状に周回する螺旋状溝部を有する軸状部材の外周面との間で画定されるものであり、
前記溝部は、該溝部の壁面から突出し、前記軸状部材を間に挟むとともに前記検出エリアの近傍に位置する一対の凸部を有し、
前記凸部の少なくとも一つは、前記軸状部材に面する側と反対側において傾斜面を有する血液凝固時間測定用カートリッジ。 A measurement flow path for containing blood;
An inlet provided on one end side of the measurement channel, for introducing blood into the measurement channel;
A communication port provided on the other end side of the measurement channel, and capable of sucking or pressurizing blood introduced into the measurement channel from the air or the injection port of the measurement channel;
It is possible to transmit light to a predetermined portion of the measurement flow path, and reciprocate in the measurement flow path as the air or blood in the measurement flow path is sucked or pressurized from the communication port. A detection area in which whether or not blood is present in the predetermined portion is detected by light, and
The measurement flow path, have a spiral flow path at least in part,
The spiral flow path is formed between a wall surface of a groove portion connecting the injection port and the communication port, and an outer peripheral surface of a shaft-like member having a spiral groove portion that is accommodated in the groove portion and spirals around the surface. Is defined by
The groove portion protrudes from the wall surface of the groove portion, and has a pair of convex portions located in the vicinity of the detection area while sandwiching the shaft-shaped member therebetween,
At least one of the convex portions is a blood coagulation time measuring cartridge having an inclined surface on a side opposite to the side facing the shaft-shaped member . 請求項１に記載の血液凝固時間測定用カートリッジをセットする血液凝固時間測定装置であって、
前記検出エリアに対応する位置に設けられ、光によって前記血液を検出可能な検出手段を備える血液凝固時間測定装置。 A blood coagulation time measuring device for setting the blood coagulation time measuring cartridge according to claim 1 ,
A blood coagulation time measuring device provided with detection means provided at a position corresponding to the detection area and capable of detecting the blood by light.
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