JPH0225404Y2 - - Google Patents

Description

[Detailed description of the invention] (Field of industrial application) The invention relates to a device that collects plasma from a blood donor by membrane separation, which is the raw material for plasma preparations used for treatment and nutritional supplementation in the medical field. . More specifically, the present invention relates to a plasma collection device using a double needle method that can be connected to a human body and collect plasma immediately after priming.

(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. 1.54, No.
11, 1984, p534-p539, etc.). Among them, the double-needle method, which uses two puncture needles, a blood collection needle and a blood return needle, is considered to be a safe method.

In this double needle method, as shown in FIG. 2, blood is drawn from a donor using a blood pump 3 and supplied to a membrane module 4, and blood cell components that do not pass through the membrane are returned to the donor through a blood return needle. On the other hand, the plasma components that have passed through the membrane are collected into a plasma storage bag 11 by a plasma withdrawal pump 8.

When collecting plasma using such a separation membrane, attach the membrane module and circuit to the device,
An operation of washing with physiological saline (hereinafter referred to as priming process) is always performed. For wet membranes, this priming process completely replaces air, fillers, and deposits existing on the inner and outer surfaces of the membrane and inside the membrane walls with physiological saline, and removes the parts such as separation membranes and circuits that are in direct contact with blood. The purpose is to wash away foreign substances that adhere to the body and prevent them from entering the body. On the other hand, dry separation membranes have the following purposes in addition to the above purposes:
Furthermore, the purpose is to moisten the separation membrane and improve the affinity between the membrane and blood.

(Problem that the invention aims to solve) However, if blood is collected immediately after the priming process, the collected plasma will be diluted with physiological saline remaining in the membrane module or blood circuit, and the total protein concentration in the collected plasma will decrease. A problem arose. Therefore, after the priming process, there is a method of disconnecting the blood circuit connected to the membrane module, draining all the physiological saline inside the membrane module and circuit by gravity or a pump, and then reconnecting the membrane module and blood circuit. However, in this case, there is a risk of blood leaking to the outside due to an error in judgment or operation, and there is also a risk of bacteria entering from the outside when the membrane module and the blood circuit are connected. Therefore, removal of the membrane module and circuitry should be avoided after the priming process.

(Means for Solving the Problems) Therefore, the present invention provides a method for priming the membrane module and circuit attached to a plasma collection device using the double needle method, and then inserting the membrane module into the filtrate chamber of the membrane module without removing the membrane module and circuit. The object of the present invention is to provide a device for draining residual saline and collecting plasma with a high total protein concentration. That is, the present invention is equipped with a blood collection needle, a blood pump, a membrane module that separates blood into plasma and blood cells via a separation membrane, and a bag that stores the plasma separated by the membrane module. In a plasma collection device that separates plasma with a membrane module, stores the separated plasma in a bag, and returns blood cells from a blood return needle, a valve is attached to an opening provided in the upper side wall of the filtrate chamber of the membrane module. Further, a branch pipe with a valve attached thereto or a three-way switching valve is provided in the circuit connecting the membrane module and the plasma storage bag, and the two valves are opened at the end of priming, or the valves are opened at the same time. This plasma collection device is characterized in that the physiological saline remaining in the filtrate chamber of the membrane module is discharged from a branch pipe or the three-way switching valve by operating the three-way switching valve.

(Function) The plasma collection device of the present invention has an opening equipped with a valve in the upper side wall of the filtrate chamber of the membrane module, and a branch pipe or three-way valve equipped with the valve in the circuit connecting the membrane module and the plasma storage bag. A switching valve is provided, and the filtrate chamber is opened to the atmosphere by opening these two valves or operating a three-way switching valve (to avoid contamination from the air, it is preferable to provide an air filter with a pore diameter of 0.2μ or less). Then, the physiological saline remaining in the filtrate chamber of the membrane module can be discharged by gravity (a pump may be used) through a valve provided in the branch pipe or a three-way switching valve. Therefore, since the filtrate chamber is empty at the time of plasma collection, plasma with a high total protein concentration can be collected.

(Example) Next, an example of the plasma collection device of the present invention will be described with reference to the drawings. FIG. 1 is a flowchart during the priming process of the device of the present invention, in which the blood collection needle 2 that punctures the donor's vein and serves as the flow path when blood is collected is connected to the blood circuit 12.
It is connected to the membrane module 4 via the blood pump 3. The blood cell circuit 13 connected to the blood cell outlet of the membrane module is connected to a blood return needle 7 that punctures a blood donor's vein and serves as a flow path for returning blood cells. Further, a plasma circuit 14 is connected to a plasma extraction port provided at the bottom of the membrane module via a plasma extraction pump 8, and the tip of this circuit is open. The plasma circuit 14 may be connected to the plasma reservoir bag 11. In this case, during the priming process, it is necessary to open the valve 15, which will be described later, and discharge the physiological saline from the valve. A branch pipe 10 is provided in the plasma circuit 14, and a valve 1 is installed in this branch pipe.
5 is attached. A three-way switching valve may be used instead of the branch pipe and valve described above. An opening is provided in the upper side wall of the filtrate chamber of the membrane module, and a valve 6 is attached to this opening. This valve has an air filter 5 to avoid contamination from the air.
is installed. During the priming process, the blood collection needle 2 is inserted into the physiological saline bag 1. When the blood pump 3 is operated in this state, physiological saline is supplied to the membrane module 4. Physiological saline that has filled the membrane module and overflowed from the module is discharged from the tip of the blood cell circuit 13. When the physiological saline is discharged from the blood cell circuit, the plasma extraction pump 8 is activated and the filtrate that has passed through the membrane is transferred to the plasma circuit 1.
Discharge from the tip of 4. When priming is completed, the blood pump 3 is stopped. Next, the blood collection needle 2 is removed from the saline bag 1. Then blood circuit 1
Physiological saline remaining in the blood chambers of the blood collection needle 2 and the membrane module 4 is discharged from the tip of the blood collection needle 2. Further, the physiological saline remaining in the plasma circuit 14 is discharged from the tip of the plasma circuit. In this state, the plasma circuit 14 is connected to the plasma storage bag 11. However, in this state, physiological saline remains in the filtrate chamber and part of the plasma circuit of the membrane module, and if blood is collected in this state, the plasma that has passed through the membrane will be diluted with physiological saline. Therefore, in the present invention, by opening the valve 6 attached to the opening in the upper side wall of the membrane module and the valve 15 attached to the branch pipe 10 provided in the plasma circuit 14, it is possible to prevent the residual liquid from remaining in the filtrate chamber and a part of the plasma circuit. Pump 8 for removing plasma from physiological saline
is discharged from the branch pipe. The two valves may be controlled to open and close in conjunction with each other.

When priming is completed, as shown in Fig. 2, the blood collection needle 2 and the blood return needle 7 are inserted into the donor, the plasma circuit is connected to the plasma storage bag, and blood collection is started with the above two valves closed. Ru.

(Effects of the invention) As described above, when collecting plasma by membrane separation, the device of the invention can collect plasma with a high total protein concentration without being affected by dilution with physiological saline during priming. At the same time, since the flow path is automatically switched without reconnecting the blood circuit, there is no contact with external objects, eliminating the possibility of contamination.

[Brief explanation of the drawing]

FIG. 1 is a flowchart during priming processing of the device of the present invention, and FIG. 2 is a flowchart during blood collection. 1...Physiological saline bag, 2...Blood collection needle, 3...
...Blood pump, 4...Membrane module, 6...Valve, 7...Blood return needle, 8...Plasma extraction pump,
10...Branch pipe, 11...Plasma storage bag, 12
...Blood circuit, 13...Blood cell circuit, 14...Plasma circuit, 15...Valve.

Claims (1)

[Scope of utility model registration request] The blood collection needle includes a blood collection needle 2, a blood pump 3, a membrane module 4 that separates blood into plasma and blood cells via a separation membrane, and a bag 11 that stores the plasma separated by the membrane module, and the blood introduced from the blood collection needle. In this plasma collection device, the separated plasma is stored in a bag while the blood is separated by a membrane module, and the blood cells are returned from a blood return needle 7. and a branch pipe 1 with a valve 15 attached to the circuit 14 connecting the membrane module and the plasma storage bag 11.
By providing a zero or three-way switching valve and opening the two valves 6 and 15 at the end of priming, or by opening the valve 6 and operating the three-way switching valve at the same time, the remaining in the filtrate chamber of the membrane module can be removed. 1. A plasma collection device characterized in that the plasma collection device is configured to discharge physiological saline from a branch pipe or a three-way switching valve.