JP6415775B1 - Blood coagulation time measurement cartridge and blood coagulation time measurement device - Google Patents

Abstract

A 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

  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.

  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.

  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.

US Pat. No. 5,372,946

  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.

  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.

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 is formed between the groove portion, the narrow portion protruding from the wall surface of the groove portion to narrow the measurement flow path, and in the vicinity of the detection area with the shaft member interposed therebetween. Is a blood coagulation time measuring cartridge having a pair of convex portions located at the same position .

  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.

  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).

  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. .

  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.

It is a perspective view which shows one Embodiment of the cartridge for blood coagulation time measurement according to this invention. 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. 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) 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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: 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)

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 forms a constricted portion that protrudes from the wall surface of the groove portion and narrows the measurement flow path, and has a pair of convex portions that are positioned in the vicinity of the detection area with the shaft-shaped member interposed therebetween. Measurement cartridge. 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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