JPH01450A - Hemolysis detection device - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

[Detailed Description of the Invention] [Industrial Application Field] The present invention relates to a hemolysis detection device in a donor pheresis device used to separate plasma components from blood.
- In detail, when detecting the rate of hemolysis in the plasma separated by the donor pheresis device and determining whether the plasma is in a hemolyzed state above a predetermined level, the tube through which the plasma flows is The structure is configured such that light emitted from a light emitting element of one wavelength is irradiated and the transmitted light is received by an optical sensor, and the magnitude of the output signal obtained from the optical sensor determines whether the plasma is in a state of hemolysis exceeding a predetermined level. The present invention relates to a hemolysis detection device that enables detection and determination of hemolysis.

[Background of the Invention] Conventionally, donor pheresis devices have existed as devices for separating plasma components in blood. This donor pheresis device is a device that separates blood into blood cell components and plasma components through a predetermined filter.The blood cell components are returned to the body, and the plasma components are used for therapeutic purposes. It is configured to be stored for use.

In this case, the membrane pressure of the filter installed in the donor pheresis device or the pump pressure of the pump that circulates blood fluctuates for some reason, and as a result, the blood cell components are split and the split blood cell components are added to the plasma component. It has been pointed out that there is a possibility that the so-called hemolytic state may be caused.

Therefore, various hemolysis detection devices have been proposed to detect this hemolysis state. FIG. 1 shows an example of this type of conventional hemolysis detection device. This technology is disclosed in Japanese Patent Application Laid-open No. 62-838, and includes light emitting diodes 2.4 of different wavelengths, e.g. red light and green light, and a tube 6 through which plasma flows. The output signals of the photodiode 8 that transmits the light and receives the transmitted light, and the output signal of the photodiode 8 are alternately switched, and the light emitting state of the light emitting diode 2.4 is simultaneously switched,
A sample and hold circuit 12.14 that samples and holds the output signal of the photodiode 8 related to the transmitted light of the light emitting diode 2.4, and a sample and hold circuit 12.1.
4, and a comparator 18 that compares the output signal of the multiplication circuit 16 with a predetermined reference value V3.

In the above configuration, the output signal of the comparator 18 is used as a hemolysis alarm signal, noting that the ratio of the amount of transmitted light related to the red light and green light changes when plasma becomes hemolyzed. .

However, the hemolysis detection device according to the related art has the complexity of having to accurately control the light emission timing of the two color light emitting diodes 2.4, the complexity of having to prepare light emitting diodes of different wavelengths, and the overall problem. Since the number of parts used is large, the reliability of the device as a whole is reduced and the manufacturing cost is high.

[Object of the Invention] The present invention has been made to overcome the above-mentioned disadvantages, and when detecting the rate of hemolysis in plasma separated by a donor pheresis device, only one tube is used in the tube through which the plasma flows. irradiate with light emitted from a single wavelength light emitting element,
The transmitted light is received by an optical sensor, and hemolysis occurs only when an output signal that is a predetermined percentage lower than this value is introduced into the optical sensor, based on the output signal obtained from the optical sensor at the start of plasma collection. configured to determine that there is,
As a result, it is an object of the present invention to provide a hemolysis detection device that can accurately detect the rate of hemolysis and has an extremely simple configuration.

[Means for Achieving the Object] In order to achieve the above object, the present invention provides a single light-emitting element that irradiates light to a poor flow channel through which plasma flows, and a light emitting element that irradiates light to a poor flow channel through which plasma flows, and a light-receiving element that detects hemolysis in plasma by detecting hemolysis, and a comparator that introduces an output signal corresponding to the amount of light transmitted through the light-receiving element into one input terminal and a reference level signal into the other input terminal. The reference level signal is a signal at a predetermined level corresponding to the amount of light at which hemolysis is considered to have occurred and which is less than the amount of transmitted light at the time of starting plasma collection stored in the storage means, The comparator compares the reference level signal with an output signal of a light receiving element that changes due to hemolysis in plasma flowing through the flow path, and when the output signal becomes equal to or lower than the predetermined level of the reference level signal, the comparator The present invention is characterized in that the drive source for plasma collection is configured to be substantially stopped by a stop signal output from the plasma collection drive source.

[Embodiments] Next, preferred embodiments of the hemolysis detection device according to the present invention will be described in detail with reference to the accompanying drawings.

FIG. 2 is a schematic diagram illustrating the configuration of a donor pheresis device incorporating the hemolysis detection device according to the present invention. In FIG. 2, reference numeral 30 indicates a donor felysis device, which includes a blood reservoir 32 for storing blood, a filter 34 for separating plasma from blood, and a blood sampling bag 36 for collecting plasma. It basically consists of. Blood B is collected into the reservoir 32 from an artery or vein of a human body 38 via a first clamp 40 by the action of a blood pump 42 . The collected blood B is introduced into the plasma separation filter 34 through the first chamber 48 by the action of the circulation pump 46, and the plasma P is transferred from one output passage of the separation filter 34 to the plasma pump 50 and the hemolysis method according to the present invention. The sample is introduced into the sample bag 36 via the detection device 52. On the other hand, the other output path of the separation filter 34 is connected to the second output path.
It is configured to communicate with the reservoir 32 via the clamp 54, and to return blood to the human body 38 via the second chamber 56 and the third clamp 58 when blood is returned.

FIG. 3 is a schematic block diagram of the hemolysis detection device 52, which is a main part of the present invention, in the donor pheresis device 30 shown in FIG. A light emitting diode 61 that emits green light and a light sensor 62 that detects the transmitted light are provided.

The current output signal of the optical sensor 62 related to the transmitted light is introduced into the comparison input terminal IN of the voltage comparator 70 via a current/voltage conversion circuit 68 composed of an operational amplifier 64 and a resistor 66, and is also subjected to A/D conversion. The data is loaded into a RAM (not shown) in the microcomputer 78 via the microcomputer 72. On the other hand, the output signal of the microcomputer 78 is configured to be introduced to the reference input terminal REF of the voltage comparator 70 via a D/A converter 80. Note that the output signal of the voltage comparator 70 is introduced into other input terminals of the microcomputer 78.

The hemolysis detection device according to the present invention is basically constructed as described above, and its operation and effects will be explained next.

First, it is assumed that the necessary portion of the donor pheresis device 30 is filled with physiological saline before blood collection. Then, when starting blood collection, the third clamp 58 is closed, and the first clamp 40 and second clamp 54 are opened. At this time, blood B is collected from the human body 38 and stored in the reservoir 32 by the rotation of the blood pump 42. In this case, at the same time, the circulation pump 46 operates to supply blood B into the plasma separation filter 34 via the first chamber 48, and the blood B that has passed through the filter 34 is transferred to the reservoir 3.
It is returned within 2. In this case, the filter 34 is a filter that does not pass molecules related to blood cell components to the plasma collection bank 36 but only passes molecules related to plasma components, and the plasma P separated by this filter 34 is transferred to the plasma pump 50.
Serum collection bank 36 via hemolysis detection device 52 due to 0 action.
is stored in

On the other hand, when returning blood, the first clamp 40 and the second clamp 54
is closed and the third clamp 58 is opened, and furthermore, the blood pump 42 is stopped and only the circulation pump 46 and the plasma pump 50 are operated. Therefore, the blood B containing some concentrated red blood cell components in the reservoir 32 is transferred to the second chamber which operates as a blood return chamber.
The blood is returned to the human body 38 through the chamber 56, and the plasma P is introduced into the blood sampling bag 36 via the separation filter 34.

Note that the first chamber 48 is for preventing air bubbles from entering the filter 34.

Therefore, as described above, reference numeral 52 is a hemolysis detection device according to the present invention, and the hemolysis detection device 52 monitors the hemolysis state during plasma separation, and if hemolysis exceeding a certain standard value occurs, Operates to stop collection work.

Next, this effect will be explained. First, when plasma collection is started, plasma flows through the bulging portion 60a of the tube 60, as shown in FIG.

In this case, the emitted light from the light emitting diode 6I that emits green light passes through the plasma P in the bulged portion 60a, and the transmitted light is detected by the optical sensor 62.

In this case, at the start of plasma collection, the donor pheresis device 30 is normally in an ideal groin pressure state, so hemolysis does not occur, and the plasma P is clear plasma or milky milky plasma. Therefore, the transmitted light from the green light emitting diode 61 is received by the optical sensor 62 with almost no attenuation. Therefore, at the start of plasma collection, the amount of light-receiving current received by the optical sensor 62 is at a large level, and the output signal of the current/voltage conversion circuit 68 becomes the maximum voltage signal v1,8. And this signal is A/
The data is stored in a RAM (not shown) in the microcomputer 78 via the D converter 72. Then, a predetermined setting value is set by a program written in advance in a ROM (not shown) in the microcomputer 78, and the value is
It is applied to the reference input terminal REF of the voltage comparator 70 via the /A converter 80.

In this case, the set value is determined with reference to the experimental results in Table 1, for example. That is, Table 1 shows the current/voltage conversion circuit 68 when the hemolysis of transparent plasma and milk layer plasma is approximately 0% (i.e., at the start of plasma collection), and when the hemolysis increases to 20/d1 and 50/d1. This is a table showing the output voltage, and as can be easily understood from Table 1,
For example, in the case of transparent plasma, the output voltage when there is no hemolysis is 10.9V, the output voltage when hemolysis is 20■/dIl is 8.3V, and the output voltage when hemolysis is 50■/dIl is 6.6V. This is easily understood. In this case, the percentage display of the output voltage when hemolysis is 20 mg/d1 is 76% as shown in parentheses compared to the case without hemolysis. Similarly, 50■/
At time a, it becomes 60.5%.

On the other hand, for the milk-paste plasma, the hemolytic state was 80% and 63.3%, respectively, compared to when there was no hemolysis.

Therefore, from the experimentally confirmed values shown in Table 1, the set value for hemolysis detection is, for example, 50% of the voltage value when there is no hemolysis.
% or more and less than 100%, preferably 75%, the difference in detection voltage related to the transparency of plasma P,
In other words, it can be understood that although there are differences in detection voltage due to individual differences, substantially the same degree of hemolysis can be detected by setting the same value.

Table 1 That is, in the block diagram of FIG. 3, a value of 75% of the voltage value read at the start of plasma P collection is set to the reference input terminal REF of the comparator 70, and during plasma P collection, the input voltage and the The rate of hemolysis of the collected plasma P is continuously monitored by comparing it with a set value. If the plasma P becomes turbid due to the reasons described above, the amount of transmitted light received by the optical sensor 62 decreases, and the voltage introduced into the input terminal IN of the comparator 70 becomes a value smaller than the set value. At times, the output signal of the comparator 70 is inverted, and the microcomputer 78 recognizes from the inverted output that the hemolysis rate of the plasma P has exceeded a set value, which is the so-called caution level. In this case, the donor pheresis device 30 is configured to be stopped by an output signal (not shown) from the microcomputer 78, so that the collection of plasma P is stopped. Therefore, when the filter 34 or the like that is the cause of the red turbidity of the plasma P is replaced, the plasma P collection operation is resumed. In this case, the reference input terminal RE of the comparator 70
The setting value set in F may be configured to set a new value. In that case, the microcomputer 78 is configured so that the setting value is once cleared by the inverted signal of the comparator 7o.
Of course, it is sufficient to write the program in advance.

[Effects of the Invention] As described above, according to the present invention, when detecting the rate of hemolysis in plasma separated by a donor pheresis device,
The tube through which plasma flows is irradiated with light emitted from a light emitting element of a single wavelength, and the transmitted light is received by an optical sensor, and the output signal obtained from the optical sensor at the start of plasma collection is used as a reference. The hemolytic state is determined to be present only when a signal that is lower than this value by a predetermined percentage is introduced. Therefore, it is possible to efficiently detect the hemolyzed state of plasma with an extremely simple configuration and without causing variations due to individual differences.

Although the present invention has been described above with reference to preferred embodiments, the present invention is not limited to these embodiments.
Of course, various improvements and changes in design are possible without departing from the gist of the present invention.

[Brief explanation of drawings]

FIG. 1 is an explanatory diagram of a hemolysis detection device according to the prior art, FIG. 2 is an explanatory diagram of a schematic configuration of a donor felysis device incorporating the hemolysis detection device according to the present invention, and FIG. 3 is an explanatory diagram of a hemolysis detection device according to the present invention. It is a block diagram. 30... Donor pheresis device 32... Blood reservoir 34... Filter 36... Serum collection bag 52... Hemolysis detection device 60... Tube 60a... Swollen portion 61... Light emission Diode 62... Optical sensor 68... Current/voltage conversion circuit 70... Voltage comparator 72... A/D converter 78... Microcomputer 80... D/A converter FIG, 3

Claims (4)

[Claims] (1) A single light-emitting element that irradiates light to a channel through which plasma flows, a light-receiving element that detects hemolysis in the plasma by detecting the amount of transmitted light passing through the flow channel, and a light-receiving element that It consists of a comparator that introduces an output signal corresponding to the amount of transmitted light into one input terminal and a reference level signal into the other input terminal, and the reference level signal is set at the plasma collection start time stored in the storage means. A signal at a predetermined level corresponding to an amount of light that is equal to or less than the amount of transmitted light at which hemolysis is considered to have occurred; and the output signal of the light-receiving element, which changes according to A hemolysis detection device comprising: (2) A hemolysis detection device according to claim 1, in which the single light emitting element is a light emitting element that emits green light. (3) The hemolysis detection device according to claim 1 or 2, wherein the signal at the predetermined level is 50% or more and less than 100% of the signal level detected at the start of plasma collection. . (4) The hemolysis detection device according to claim 3, wherein the signal at the predetermined level is 75% of the signal level detected at the time of starting plasma collection.