JPS62137059A - Plasma sampler - 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 Field of Application) The present invention relates to the collection of plasma from blood donors by membrane separation, which is the raw material for plasma preparations used for treatment and nutritional supplementation in the medical field. The present invention relates to devices, particularly devices that automatically perform blood removal and blood return cycles.

(Prior art) Plasma collection has traditionally been carried out mainly using centrifugation devices, but recently a plasma collection method using a separation membrane has been studied (Medical Instruments Vol. 54A11.1984, P5
34-P539 etc.). Among them, the single-needle method, in which blood is repeatedly removed and returned with a single puncture needle, is said to be an excellent method that reduces the mental burden on the donor. In this method, it is difficult to automate the switching between blood removal and blood return cycles, so the operator has to manually switch between them while monitoring the amount of blood removed and blood returned.

(Problems to be Solved by the Invention) However, when trying to collect plasma in a short time by manually switching cycles, the amount of blood collected at one time is large, the amount of blood circulating in the donor's body decreases, and - If the amount of blood collected each time is reduced, it will take a long time to collect the plasma, and the blood in the blood flow path will be concentrated, making it difficult to collect the plasma. Therefore, it is absolutely necessary to switch between blood collection and blood return in an optimal cycle while paying attention to the decrease in blood circulation in the donor's body.

(Means for Solving the Problems) Therefore, it is an object of the present invention to solve the above problems and provide a plasma collection device that can automatically switch between blood collection and blood return.

In order to achieve the above object, the configuration of the present invention is shown in FIG.

The blood flow path 1 includes a membrane module 3 that separates the blood taken out from the blood collection needle H into blood cell components and plasma components, a bag 6 that stores the blood cell components separated by the membrane module, and a blood pump 4 that can be rotated in forward and reverse directions. , is equipped with a first detector 5 that detects the flow rate (amount of blood removed) in the blood flow path 1, stores the separated blood cell components in a bag 6, and when blood is returned, the blood pump 4 is reversed to collect the blood inside the bag 6. The blood cell components are returned to the human body through the blood collection needle H.

The plasma flow path 2 includes a bag 7 for storing plasma components separated by the membrane module /L/3, a plasma pump 8, and a second detector 9 for detecting the flow rate of the plasma flow path 2. The plasma components separated by the membrane module 3 are stored in a bag 7.

The blood cell component outlet of the phlegm module 3 is disposed at the top. Although it is usually set in the vertical direction, it may be arranged in an inclined manner so that the outlet for blood cell components is at the top and the outlet for plasma components is at the bottom. A branch pipe for discharging the priming liquid is provided between the membrane module 3 of the blood flow path 1 and the blood cell storage bag 6, and the parbue 2 is attached to the branch pipe. Furthermore, a detector 14 is provided at the membrane module outlet of the blood flow path 1 to identify the type of fluid in the flow path.

- A plasma collection start means 15, a plasma collection means 16 and a pump stop means 17 are provided as force control means. The plasma collection starting means 15 receives an external start signal, opens the valve 12, drives the blood pump 4 in normal rotation, supplies blood to the membrane module, and fills the priming liquid in the membrane module with the blood. It is discharged to the outside through the discharge valve 12. When all of the 1 Raiminda fluid in the membrane module is expelled by blood and the blood flows out from the membrane module into the blood flow path, the valve 2 receives a detection signal from the detector 14.
is closed, and the plasma bonder 8 is driven to start collecting plasma. Further, when the blood plasma collecting means 16 receives a detection signal from the first detector 5 and the amount of blood removed reaches a predetermined value, the blood pump 4 is driven in reverse to return blood to the detector ]4.
When detecting air, the blood pump 4 is driven in normal rotation in response to a detection signal from the detector 14 to collect blood. Next, the pump stop means 17 receives a detection signal from the second detector 9 and when the amount of plasma collected reaches a predetermined value, stops driving all pumps to complete the plasma collection.

(Function) According to the above configuration, the priming liquid in the membrane module is smoothly discharged to the outside from the valve 12 due to the blood flowing from the lower side to the upper side of the membrane module 3, so that the priming liquid flows into the plasma flow path 2 when blood is returned. does not dilute the plasma. In addition, the blood removal and blood return cycles are switched based on signals from the blood removal amount detector 5 and the detector 14 that identifies the type of fluid (blood or air) in the blood flow path 1 at the outlet of the membrane module 3. It can be done automatically.

(Example) Next, an embodiment of the present invention will be described with reference to the drawings.

First, prior to explaining the plasma collection operation, the plasma collection device will be explained. Note that FIG. 2 shows an example in which ACD liquid is used as an anticoagulant.

FIG. 2 is a flow diagram during plasma collection (blood removal), where 1 is a blood flow path and 2 is a plasma flow path. The blood taken out from the blood collection needle H is transferred to a first chamber 21 that detects blood withdrawal pressure.
The blood is then pressurized by the blood pump 4, enters the second chamber 23 that detects the inlet pressure of the membrane module A/3, and is introduced from below into the membrane module /L/3 set in the vertical direction. It is separated into blood cell components and plasma components. This membrane module 3 accommodates a membrane for separating plasma and blood cells, such as a plate-shaped, tube-shaped, or hollow fiber-shaped separation membrane made of polyvinyl alcohol, polysulfone, polyethylene, or the like. Usually, a hollow fiber membrane module is used in which a large number of hollow fiber separation membranes are accommodated in a housing.

The blood cell components separated by the membrane module 3 are supplied to the blood cell storage bag 6 and stocked therein.

Furthermore, a flow path 26 is connected to the blood inlet of the blood circuit 1 via an ACD pump 19 for supplying an anticoagulant, such as ACD liquid, to the blood flow path 1 to prevent coagulation of blood during treatment. The ACD liquid supply channel 26 is connected to the ACD liquid container 24. When blood is collected, a certain amount of ACD liquid is added to blood flow path 1.
The supplied amount is detected by the detector 20.

Further, a sensor 22 for detecting the blood withdrawal pressure is connected to the first chamber 21, and all pumps are stopped when this pressure exceeds a predetermined value. An inlet pressure sensor 24 to the membrane module is connected to the second chamber 23 . Further, a sensor 25 for detecting plasma outlet pressure is connected to the air inlet of the membrane module, and the two sensors 24 and 25 detect the transmembrane pressure difference (TMP). The amount of plasma extracted by the plasma pump 8 is controlled so that this transmembrane pressure difference becomes a predetermined value.

The plasma components separated by the membrane module 3 are stored in the plasma storage bag 7 by the plasma pump 8. 3. When returning the blood cell components, the blood pump 4 is reversed, and the ACD pump 1
When the blood cell storage bag 9 is stopped, the blood cell components in the blood cell storage bag 6 are returned to the human body through the blood collection needle H.

A detector 14 is provided at the outlet of the membrane module A/3 of the blood flow path 1 to identify the fluid in the blood flow path. This detector 14 detects blood or air, and is of a type that irradiates light or sound from one side of the blood flow path and measures its transmittance.

Usually phototubes are preferably used.

Further, the blood pump 4 includes a first detector 5 that detects the flow rate (blood removal amount) of the blood flow path I based on the rotation speed of the blood pump, and the plasma pump 8 includes a first detector 5 that detects the flow rate (blood removal amount) of the blood flow path I based on the rotation speed of the blood pump. A second detector 9 that detects the flow rate (volume of collected plasma) of the plasma flow path 2 based on the flow rate of the plasma flow path 2 is connected to each of the second detectors 9 .

40 is a control device consisting of a microcomputer;
During blood processing, the controller 40 controls the detector 5.9.
While checking the flow rate detection signal from the detector 14, the fluid identification signal from the detector 14, and the pressure detection signal from each pressure sensor 22, 24.25, each flow rate in the blood flow path 1 and the plasma flow path 2 and the membrane module The rotational speed of the plasma pump 8 is controlled so that the membrane pressure (TMP) in step 3 becomes an appropriate value, and blood is processed while repeating blood removal and blood feeding. Also, if the blood withdrawal pressure becomes abnormal, all pumps are stopped.

Next, the operation of the plasma collection device having the above configuration will be explained.

In FIG. 3, the blood collection needle H is connected to a blood donor. In addition, the control device 40 controls driving and stopping of each of the blood pump 4 and plasma pump 8, and each valve 11.12.
A blood collection start means 15, a plasma collection means I6, and a pump stop means 17 for opening and closing the pump are built-in.

On the other hand, in the membrane module /L/3 that has undergone priming, the inside of the hollow fiber and the blood flow path 1 are filled with priming liquid, so a branch pipe is connected to the membrane module outlet of the blood flow path 1 to discharge this priming liquid. A valve 12 is attached to this branch pipe.

This valve is closed at the end of priming.

This state is shown as step S-1 shown in FIG.

Plasma collection begins at step S-1 in Figure 4. First, we will outline the plasma collection based on steps S-2 to S-8 in Figures 5 to 8 and the flowchart in Figure 9. explain.

In FIG. 9, abbreviations are used for each part.

As shown in Figures 4 to 8, the abbreviations are Pv for pulp 12, BP for blood pump 4, PP for plasma pump 8, and PP for ACD pump 19.
are represented respectively.

In step S-2 of FIG. 5, all pumps 5.8
．． 19 is stopped and the pulps 11 and 12 are closed, the control device 40 receives an external start signal, operates, opens the pulp 12, and drives the ACD pump 19 and blood pump 4, and blood is donated. Blood is taken from the person. This blood is supplied to membrane module V3 while being mixed with ACD fluid. At this time, blood is supplied into the hollow fibers from the lower side of the membrane module 3, so the priming liquid in the hollow fibers is expelled by the blood, and is discharged from the membrane module through the branch pipe to the outside of the pulp 12. .

After expelling the priming liquid inside the hollow fiber, when the blood is led out from the membrane module /l/3 to the blood flow path 1, the detector 1 receives a blood identification signal and the expulsion of the priming liquid inside the membrane module is completed. In step S-3 shown in FIG. 6, the control device 40 drives the plasma pump 8 to enter the blood removal process. As a result, the blood cell components are stored in the bag 6, and the plasma components that have passed through the membrane are stored in the bag 7.

Furthermore, when the amount of blood removed reaches a predetermined value upon receiving a detection signal from the blood amount (removed amount) detector 5, the blood removal process is deemed to have ended, and in step S-4 shown in FIG. 40
The drive of the ACD pump 19 is stopped, the blood pump 4 is driven in reverse, and the blood return process begins. In this step, the blood cell components stocked in the bag 6 are returned to the blood donor. When the detector 14 receives the air identification signal of the blood flow path, it is assumed that the return of the blood cell components in the bag to the donor has been completed, and the control device 40 turns on the ACD pump 19 in step 5 shown in FIG. The blood pump 4 is driven to rotate normally, and the process returns to the above-mentioned blood removal step. In the blood return process, it is necessary to introduce air into the blood flow path 1, so for example, an air inlet with a sterilization filter is attached to the top of the bag 6, or an additional air inlet is installed in a branch pipe installed in the blood circuit. A branch pipe may be provided, a pulp with a sterilization filter attached to the branch pipe may be provided, and this pulp may be released in the blood return process. A predetermined amount of plasma components is collected by repeating the cycle of the blood removal step and blood return step.

Next, when the flow rate of the plasma flow path 2 (the amount of plasma collected) reaches a predetermined value in response to the detection signal from the detector 9, it is assumed that the plasma collection has been completed, and all pumps 4.8.19 are activated. Stop and complete plasma collection.

When the plasma collection is completed, a collection step begins in which the blood remaining in the blood channel and the membrane Modiny/l/3 is returned to the donor. In the collection process, the blood pump 4 is driven in reverse as in the blood return process shown in FIG. During this time, plasma pump 8 and ACD pump 19 remain stopped. The blood pump 4 is driven in reverse to open the first chamber 21t of the blood flow path 1.
When the chamber becomes empty, the blood pump 4 is stopped in response to a detection signal from a detector 13 provided at the outlet of the chamber for identifying air. Next, the pulp 11 attached to the opening provided in the upper side wall of the membrane module 3 is opened, and at the same time, the plasma pump 8 is driven to send the residual plasma in the membrane module into the bag 7, and then the plasma pump 8 is stopped. to complete the collection process.

(Effects of the Invention) As described above, the present invention can automatically carry out the cycle of blood removal and blood feeding, so that the plasma collection operation can be carried out safely and efficiently.

[Brief explanation of drawings]

Fig. 1 is a flow diagram showing the configuration of the present invention, Fig. 2 is a flow chart showing the state during blood collection, Fig. 3 is a flow chart showing an embodiment of the present invention, and Figs. FIG. 9 is a simplified flowchart showing the operation of the device of the invention. FIG. 9 is a flowchart showing a method of controlling the device of the invention. 1... Blood flow path 2... Plasma flow path 3... Membrane module/l/4... Blood pump 5... First Detector 6...
Blood cell storage bag 7...Plasma storage bag 8...
...Plasma pump 9...Second detector 12
...Valve 14...Detector 1
5... Plasma collection start means 16... Plasma collection means 17... Pump stop means H...
・Blood collection needle

Claims (1)

[Claims] Blood is introduced into the membrane module 3 from the blood collection needle H, separated into blood cell components and plasma components, the separated blood cell components are stored in a bag 6, and when the blood is returned, the blood cell components in the bag are transferred to the blood collection needle H.
A blood flow path 1 that returns the blood to the human body, a plasma flow path 2 that introduces the plasma components separated by the membrane module 3 into the bag 7, and a blood pump 4 that is provided in the blood flow path 1 and is reversible.
A plasma pump 8 provided in the plasma flow path 2, a valve 12 attached to a branch pipe provided in the blood flow path connecting the membrane module 3 and the blood bag 6, and a valve 12 that controls the flow rate of the blood flow path 1. A first detector 5 for detecting, a second detector 9 for detecting the flow rate of the plasma flow path 2, a detector 14 for identifying the type of fluid at the membrane module outlet of the blood flow path 1, and an external Upon receiving the start signal from the blood pump 4, the valve 12 is opened and the blood pump 4 is started.
a plasma collection starting means 15 which supplies blood to the membrane module by driving the blood in the normal direction, closes the valve 12 in response to a blood detection signal from the detector 14, and drives the plasma pump 8;
In response to the detection signal from the first detector 5, when the amount of blood removed reaches a predetermined value, the blood pump is driven in reverse to return the blood cell components in the bag 6 to the human body. In response to the air detection signal, the plasma collection means 16 drives the blood pump in normal rotation to collect blood, and in response to the detection signal from the second detector 9, when the amount of plasma collection reaches a predetermined value, all A plasma collection device comprising a pump stop means 17 for stopping the drive of the pump.