JPH0116179B2 - - Google Patents

Description

[Detailed Description of the Invention] [Industrial Application Field] The present invention is a single-needle membrane separation method that uses a membrane-type plasma separator to collect only plasma and returns blood cell components to the blood donor when blood is collected from donated blood. Regarding type plasma collection device.

[Conventional technology]

The centrifugation method is one of the devices for collecting plasma from donated blood, but it is uneconomical because it requires expensive equipment.
Further, the sedimentation method, which does not require complicated equipment, is not practical because plasma separation requires a long time.

A membrane-type plasma separator using a membrane-type plasma separator is the most effective method because the separated plasma does not contain active ingredients such as platelets, but the conventional method involves inserting an indwelling needle into each vein in both arms. Because blood is circulated outside the body via the indwelling device, it places a heavy burden on blood donors.

Therefore, the present inventors developed a single-needle membrane type plasma collection device to solve the above-mentioned drawbacks, and succeeded in reducing the burden on blood donors by half. However, this device adopts an intermittent operation method in which blood is alternately sent from the donor to the membrane-type plasma separator and blood is returned from the separator to the donor. The red blood cell concentrate from which plasma has been separated from the blood is temporarily stored in a container on the return side and the return is stopped, and at the time of return, the blood feeding is stopped and the red blood cell concentrate in the container is given to the blood donor. The return cycle was time-controlled.

[Problem that the invention seeks to solve]

Since the single-needle membrane type plasma collection device performs blood feeding and return by time control, there may be a lack of accuracy in controlling the amount of concentrated red blood cells in the container, so care must be taken when collecting plasma. monitoring was required.

[Means for solving problems]

The present invention has been made to solve the above problems, and includes an indwelling needle that is placed in a blood vessel of a donor, and a blood pump that transports blood from the indwelling needle to a membrane plasma separator. A blood line and a return pump equipped with a return pump that returns the concentrated red blood cell liquid from which plasma has passed through a separation membrane equipped in the membrane-type plasma separator from the blood to the indwelling needle. and a plasma line for transporting the plasma to a plasma container, and the blood supply line includes an anticoagulant for adding an anticoagulant from an anticoagulant container to the blood transported through the blood supply line. a blood product line, the return line includes a concentrated red blood cell container communicating with the return line upstream of the return pump, the concentrated red blood cell container includes a measuring means for weighing the container; The means is connected to a control means that controls the drive of the blood feeding pump and the return pump in accordance with the measured value to switch between blood feeding and return, and the control means is configured to control when the measured value reaches a prescribed upper limit value. an upper limit value detection means for detecting that the measured value has reached a specified lower limit value, a lower limit value detection means for detecting that the measured value has reached a specified lower limit value, and a drive of the blood pump is stopped in response to a detection signal from the upper limit value detection means. The device also includes a drive switching device that starts driving the return pump at the same time, stops driving the return pump, and starts driving the blood pump in response to a detection signal from the lower limit value detection device.

[Function] The control means stops blood feeding when the measured value reaches a prescribed upper limit, and starts returning the stored red blood cell concentrate from the red blood cell concentrate container, and measures the red blood cell concentrate in the red blood cell concentrate container. Blood is collected from the membrane-type plasma separator by repeating a cycle in which when the value reaches a specified lower limit, blood supply is started, return is stopped, and the red blood cell concentrate is stored in the red blood cell concentrate container. will be held.

〔Example〕

Embodiments of the present invention will be described below based on the drawings. FIG. 1 is a flow path system diagram of an embodiment of the present invention.
In the drawings, reference numeral 1 denotes a single-needle membrane separation type plasma collection device. This device 1 consists of an indwelling needle 2 placed in a blood vessel of a donor D, and a blood pump 1 that transports blood from the indwelling needle 2 to a membrane-type plasma separator 3.
0, and the membrane-type plasma separator 3, the red blood cell concentrate is separated from the plasma that has passed through the separation membrane installed in the membrane-type plasma separator 3 from the blood. a return line 5 that returns the blood to the blood vessel of the donor D via the indwelling needle 2;
and a plasma line 6 for transporting the plasma that has passed through the separation membrane to a plasma container 7, preferably in the form of a blood bag.
Therefore, the plasma line 6 can be provided with a plasma pump 15 for transporting the plasma. The blood supply line 4 is equipped with anticoagulation means for anticoagulating blood transported through the blood supply line 4, and the means supplies an anticoagulant from an anticoagulant container 8 to the blood supply line. 4, the anticoagulant is added at a predetermined ratio to the blood flow in the blood supply line 4 by gravity flow or pump transport, and the blood is anticoagulated. It becomes blood. Various anticoagulants can be used, but when using ACD fluid, 1/9th of the blood flow rate is added. The blood feeding pump 10 is a double roller pump as shown in the figure, and the anticoagulant line 9 is also provided in the pump 10, and the internal cross-sectional area ratio of the blood feeding line 4 and the anticoagulant line 9 is When the ratio is set to 9:1, one blood pump 10 can transport blood and add a predetermined ratio of anticoagulant to the blood transport. Of course, two pumps may be used to perform blood delivery and anticoagulant delivery independently.

The return line 5 comprises a red blood cell concentrate container 11, preferably in the form of a blood bag, communicating with the return line 5, and a return pump 12 disposed downstream of the container 11.

The red blood cell concentrate container 11 is provided with measuring means 13 for weighing the container 11. The measuring means 13 is not limited to a suspension type using a spring as shown in the drawings, but also an appropriate weight method such as a platform scale type that supports the red blood cell concentrate container 11, or an ultrasonic or optical method. A capacitance method for measuring the level of the red blood cell concentrate can be adopted, and the measuring means 13 outputs a signal corresponding to the measured value, and blood sending and returning are performed alternately in accordance with this output signal. It is connected to the control means 14.

Functionally, this control means 14 includes upper limit value detection means for detecting that the measured value by the measuring means 13 has reached a prescribed upper limit value, as shown in FIG.
In response to a detection signal from a lower limit value detection means for detecting that the measured value has reached a specified lower limit value, and a detection signal from the upper limit value detection means, the drive of the blood pump 10 is stopped and the drive of the return pump 12 is started. and drive switching means for stopping the driving of the return pump 12 and starting driving the blood pump 10 in response to a detection signal from the lower limit value detecting means, and a drive switching means for stopping the driving of the return pump 12 and starting driving the blood feeding pump 10, so that the measured value of the red blood cell concentrate container 11 is The blood pump 10 is operated until the specified upper limit is reached, and the return pump 12 is stopped. Meanwhile, the blood pump 10
The blood from the donor D transported through the blood supply line 4 is anticoagulated and transported to the membrane plasma separator 3 by the operation of the blood supply line 4 . The transported blood is separated into plasma, which passes through the separation membrane installed in the membrane plasma separator 3, and red blood cell concentrate, which does not pass through the separation membrane. The plasma is pumped through the plasma line 6 into the plasma container 7 by the operation of the plasma pump 15, if provided. This plasma pump 15 sucks plasma from the plasma separator 3, improves plasma collection efficiency, and makes it possible to collect plasma at a specified flow rate. Plasma collection can also be performed based on blood pressure alone.
The red blood cell concentrate that does not pass through the separation membrane is stored in the red blood cell concentrate container 11 that communicates with the return line 5.

When the measured value of the red blood cell concentrate container 11 reaches the prescribed upper limit value, the control means 14 stops the blood pump 10 to stop blood feeding in accordance with the upper limit signal from the measuring means 13. At the same time, the return pump 12 is activated, and the plasma pump 1
5, this pump 15 is also stopped. The red blood cell concentrate stored in the red blood cell concentrate container 12 by the operation of the return pump 12 is returned to the blood vessel of the donor D via the return line 5 and the indwelling needle 2, and the measuring means 13 When the lower limit of is detected, the blood pump 1
0 operation and the return pump 12 are stopped, plasma collection and red blood cell concentrate storage are started, and the plasma pump 1
5 is installed, this pump 15 is operated.

Thereafter, intermittent plasma collection can be performed by repeating the above cycle.

In this example, the membrane type plasma separator 3 is a hollow fiber type equipped with cellulose triacetate hollow fibers with an inner diameter of 270 microns, a wall thickness of 80 microns, an effective membrane area of 0.15 m ² , an effective length of 163 mm, and a maximum pore size of 0.4 microns. Use a blood flow rate of 45
ml/min, ACD liquid flow rate 5ml/min, return flow rate 50
ml/min, the upper weight limit is set to 120 g, and the lower weight limit is set to 20 g, a plasma flow rate of approximately 15 ml/min and a red blood cell concentrate storage flow rate of approximately 35 ml/min are obtained, resulting in a delivery time of approximately 3 minutes. 500 ml of plasma can be collected in a 60-minute operation with a blood return cycle of about 2 minutes, and no blood clots in the extracorporeal line due to intermittent operation were observed, and no abnormalities in the donor due to extracorporeal blood circulation were detected. It wasn't discovered. Prior to plasma collection, the relevant parts of the device were filled with physiological saline.

Reference numerals 16 and 17 shown in the drawing are air traps installed in the blood supply line 4 and return line 5, respectively, which trap air in the related lines and also include a pressure gauge P for indicating the pressure in the related lines.
1 and P2, respectively, and P3 is a pressure gauge for indicating separation pressure, which is installed in the membrane type plasma separator 3.

〔Effect of the invention〕

The present invention includes a single indwelling needle placed in a blood vessel of a donor, a blood supply line that sends blood from this indwelling needle to a membrane-type plasma separator, a return line from the separator to the indwelling needle, and a return line that connects the indwelling needle to the indwelling needle. Single-needle plasma collection consists of a concentrated red blood cell container connected to the line, and blood feeding and return operations are controlled by detecting the upper and lower limits of the measured value of the concentrated red blood cell container. It allows for precise control of the amount of red blood cell concentrate in the system, and does not require careful monitoring during plasma collection.

[Brief explanation of drawings]

The drawings relate to an embodiment of the present invention; FIG. 1 is a flow path system diagram of the embodiment, and FIG. 2 is a functional block diagram of the control means. 2 is an indwelling needle, 3 is a membrane plasma separator,
4 is a blood supply line, 5 is a return line, 6 is a plasma line, 7 is a plasma container, 9 is an anticoagulant line, 10 is a blood supply pump, 11 is a red blood cell concentrate container, 12 is a return pump, 13 is a metering 14 is a control means.

Claims (1)

[Scope of Claims] 1. An indwelling needle that is placed in a blood vessel of a donor, a blood supply line that transports blood from the indwelling needle to a membrane plasma separator by a blood pump, and a blood supply line that transports blood from the indwelling needle to a membrane plasma separator. A return line equipped with a return pump that returns a concentrated red blood cell solution from which plasma has passed through a separation membrane equipped in this membrane type plasma separator to the indwelling needle, and a plasma line that transports the plasma to the plasma container. The blood supply line includes an anticoagulant line that adds an anticoagulant from an anticoagulant container to the blood transported through the blood supply line, and the return line includes an anticoagulant line that adds an anticoagulant to blood transported through the blood supply line, A concentrated red blood cell container communicating with the return line on the upstream side of the pump, the concentrated red blood cell container having a measuring means for weighing the container, and the measuring means controlling the blood pump and the blood pump according to the measured value. It is connected to a control means that controls the drive of the return pump to switch between blood feeding and return, and the control means includes upper limit detection means that detects that the measured value has reached a prescribed upper limit, and Lower limit value detection means detects that a prescribed lower limit value has been reached, and in response to a detection signal from the upper limit value detection means, stops driving the blood pump and starts driving the return pump, and lower limit value detection means drive switching means for stopping the drive of the return pump and starting the drive of the blood pump in response to a detection signal from the blood supply pump;
A single needle membrane separation type plasma collection device characterized by: 2. The single-needle membrane separation type plasma collection device according to claim 1, wherein the measuring means is a gravimetric method. 3. The single-needle membrane separation type plasma collection device according to claim 1, wherein the measuring means is of a capacitive type.