JPH0586235B2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION (Field of Application) The present invention relates to a plasma collection unit for collecting plasma components from a blood pool without using any special machinery or equipment.

(Prior art and its problems) In recent years, the demand for blood component transfusions has increased with advances in medicine. Particularly in Japan, there is a high demand for plasma components, and for this reason, large amounts of plasma and plasma fraction preparations are imported, and there is a desire for domestic self-sufficiency.

The first method considered for collecting plasma from a blood pool was the so-called centrifugation method, in which whole blood was collected from the blood pool, centrifuged to separate it into plasma and blood cell components, and each component recovered. In addition, in order to collect only plasma, the so-called manual plasma component collection method, in which blood cell components are returned to the blood pool, is widely used in other countries, and automatic centrifugation equipment that combines a blood pump and centrifuge is used to collect blood cells outside the body. Collecting plasma through circulation has also been practiced.

Common features of these centrifugation methods include:
First of all, it cannot be carried out without a centrifuge, it is difficult to carry out in places without power, it is difficult to secure space for a centrifuge in a narrow place such as inside a blood collection truck, centrifuges are expensive, and blood samples cannot be collected easily. Contamination of white blood cells and platelets is observed in the collected plasma. Lymphocytes among white blood cells may contain various viruses, and this contamination may lead to serious accidents. In addition, in the manual plasma component collection method, since the blood collection line is once separated from the blood pool, there is a possibility that the blood may be mistaken for other blood when it is returned, and automatic centrifugation equipment is expensive.

The next method to collect plasma after centrifugation was to use a membrane plasma separator. Plasma separated with a membrane-type plasma separator has the great advantage of not being contaminated with white blood cells or platelets, and is expected to be put to practical use in plasma collection.

As a plasma collection method using a membrane-type plasma separator,
Extracorporeal circulation methods using automatic devices including blood pumps and head methods typified by the Garland method are known. However, as mentioned in the case of centrifuges, the method of using an automatic device cannot be carried out without an automatic device, it is difficult to implement in a place without a power supply, and it is necessary to secure a space to place the automatic device in a small place. It is difficult.

On the other hand, the most typical plasma collection method using the drop method is the invention disclosed in EPC Publication No. 0114698. This is an improvement over the conventional extracorporeal circulation method using a membrane-type plasma separator, which requires the operation of a blood pump and various monitors during operation as described above, and lacks simplicity. The aim is to perform extracorporeal circulation without the use of blood plasma, and to separate plasma using the simplest possible device.

However, in the device disclosed in EPC Publication No. 0114698, no attention is paid to ease of operation, removal of air in the circuit, closedness of the circuit, etc. For example, according to an embodiment, a membrane plasma separator with a capacity of 2000 ml
and rinse with copious amounts of heparinized saline,
A separate device for injecting the anticoagulant is required, and the circuit is connected to a membrane plasma separator for rinsing agent at the site, making the operation complicated and the closed nature of the circuit not maintained.

In addition, to prevent hemolysis, wash eluate, etc.
The patient was rinsed with 2000 ml of isotonic heparinized saline solution. This means that a large amount of saline is contained in the membrane plasma separator, and the collected plasma is diluted with this saline. Only low concentrations can be obtained.

In addition, in the device of EPC publication 0114698, blood is collected in a form that passes through a membrane-type plasma separator, so the blood is subject to passage resistance of the membrane-type plasma separator. In addition, when blood is returned, the concentrated blood cell liquid must pass through the membrane plasma separator again, and the passage resistance at this time is even greater and it takes more time.

If the separation capacity of the membrane plasma separator is the same, the plasma separation rate obtained is proportional to the blood collection rate;
It is preferable for such a device to have a higher blood collection rate, and at this time, collecting blood through a membrane-type plasma separator lowers the blood collection rate due to the passage resistance, making it difficult to obtain a high plasma collection rate. , it is difficult to achieve a blood velocity most suitable for the membrane plasma separator used.

Furthermore, as a device for easily collecting plasma,
The invention of EPC publication 0208061 is known. The device disclosed in this publication requires a device that measures the blood sampling rate and a device that controls the injection of anticoagulant in conjunction with the device (the former), and one that requires a device that measures the blood sampling rate and controls the injection of anticoagulant in conjunction with the device (the former), and a There are two systems: a bag system for collecting blood directly into a blood collection bag containing an anticoagulant, and a membrane-type plasma collection system (the latter) consisting of a blood transfusion set that includes a needle and connecting means at both ends and a plasma separator. be. However, the former method requires special equipment, and similar to EPC Publication 0114698, the membrane plasma separator is washed with physiological saline, etc. to remove air in the circuit, rinse the membrane plasma separator, and make it physiologically isotonic. This is not a preferred method since it is necessary to fill the circuit including the separator, and this saline solution lowers the protein concentration of the plasma obtained. Also, the latter is
In addition to diluting the above-mentioned physiological saline, it is necessary to connect the blood collection bag and the blood transfusion set on-site, making it impossible to maintain the closedness of the circuit and raising concerns about contamination from the outside world.

(Object of the Invention) The present invention has been made to solve the problems of the prior art as described above. Furthermore, the present invention provides a plasma collection unit that is capable of collecting plasma from a blood pool using only disposable parts that maintain the closedness of the system as much as possible without priming or cleaning the membrane type plasma separator.

(Structure of the Invention) The gist of the present invention includes at least a blood collection needle, a blood collection tube that connects the blood collection needle and the blood collection bag, a blood collection bag containing an anticoagulant in advance, a blood collection bag that connects the blood collection bag and a membrane-type plasma separator, and a blood collection tube that connects the blood collection needle and the blood collection bag. A membrane-type plasma separator that is partially wetted with a physiologically isotonic solution, and a membrane-type plasma separator that stores plasma separated by the membrane-type plasma separator. Plasma bag, tube that connects the membrane plasma separator and plasma bag, means for removing air bubbles in the blood cell concentrate that has exited the membrane plasma separator, tube that connects the membrane plasma separator and means for removing air bubbles, air bubbles A blood return tube is provided for guiding the concentrated blood cell solution exiting the means for removing blood to a blood collection tube connecting the blood collection needle and the blood collection bag, and each of these members forms an integrated closed extracorporeal circulation circuit, The plasma collection unit is characterized in that the plasma collection unit is sterilized and held in one bag.

The present invention also provides a plasma collection unit in which, in addition to an anticoagulant, a sterile gas such as sterile air or sterile nitrogen is sealed in the blood collection bag.

The present invention also provides a plasma collection unit in which a physiologically isotonic solution of A/100 (g) or less is added to the membrane type plasma separator with a membrane area of A cm ² .

The present invention further provides that the physiological isotonic solution is an anticoagulant, and the sum of the amount of the anticoagulant and the amount of the anticoagulant contained in the blood collection bag is an anticoagulant that is used for normal whole blood collection. A plasma collection unit equal to the amount of coagulant.

As the anticoagulant, commonly used citric acid-based ACD-A liquid, CPD liquid, etc. are used. The blood collection bag constituting the present invention contains an amount of anticoagulant calculated in advance for the scheduled amount of blood to be collected, and the connecting means (tube) connecting the blood collection bag and the membrane plasma separator is Before use, it is closed with a seal near the blood collection bag that can be broken to allow fluid to flow through. For this reason, the unit of the present invention does not require a device for continuously injecting anticoagulant in response to blood collection, nor does it require an open port for injecting anticoagulant.

In addition, it is possible to fill the blood collection bag with a small amount of sterile gas in advance, and this gas is used to send all the whole blood collected into the blood collection bag to the membrane-type plasma separator directly connected downstream. Helpful.

The membrane type plasma separator that is directly connected in advance to the downstream of the blood collection bag via a tube is not particularly limited in terms of membrane material and membrane shape as long as it can efficiently separate plasma components and blood cell components. Flat membranes and hollow fiber membranes made of cellulose acetate, polyvinyl alcohol, polymethyl methacrylate resin, polyethylene, polypropylene, polysulfone, etc. can be used, but they do not require priming or cleaning with a physiological solution before use. This is desirable.

However, if the membrane material of the membrane plasma separator is hydrophobic, plasma filtration will be difficult to occur even if blood is introduced if there is no water in the membrane pores, and with hydrophilic membranes, if there is no water in the pores, plasma filtration will not occur easily. Although plasma filtration is possible, hemolysis occurs during blood introduction.

This hemolysis is calculated as A/ ¹⁰⁰ , where the membrane area is Acm2.
(g) The following physiological isotonic solutions can be prevented by adding membrane pores.

In this way, by pre-wetting the membrane pores that serve as flow paths for plasma components, both hydrophobic and hydrophilic plasma separation membranes can be used without any problems in performance or hemolysis without washing or priming. Since plasma separation can be performed smoothly, it has become possible to incorporate it into the integrated plasma collection unit of the present invention. In the unit according to the invention, priming only needs to be performed on the tube used to return blood to the blood pool, and there is no need to clean the membrane plasma separator. Therefore, the collected plasma is hardly diluted by the physiological solution used for priming, and plasma of good quality can be obtained.

However, while it is preferable to pre-wet the membrane pores of a membrane-type plasma separator with a physiologically isotonic solution in terms of hemolysis and performance development, it is difficult to dilute the obtained plasma components with this physiologically isotonic solution. It has certain drawbacks. Therefore, by using the physiologically isotonic solution added to this membrane pore as an anticoagulant and subtracting the amount of anticoagulant added to the blood collection bag by the amount added to this membrane pore, such dilution can be avoided. Minimization is one feature of the present invention.

For hydrophobic membranes, it is preferable to use the volume of the membrane pores determined from theoretical calculations as a guideline for the minimum amount of liquid added to the membrane pores, but for hydrophilic membranes, if water is included, The membrane swells and requires slightly more volume than a hydrophobic membrane for the same porosity.

If a large amount of liquid is added to the membrane pores, and this liquid is used as an anticoagulant, the amount of anticoagulant applied to the blood collection bag will be reduced, which may cause activation of coagulation system components during blood collection. That's not a good thing. In this respect, a plasma separation membrane in which a hydrophobic porous membrane is coated with a water-insoluble hydrophilic polymer is preferable because it hardly swells with water. Furthermore, a hydrophobic membrane has a weaker ability to retain water added to the membrane pores than a hydrophilic membrane, and from this point of view as well, a membrane in which a hydrophobic membrane is coated with a water-insoluble hydrophilic polymer is preferred. In particular, for the hydrophobic membrane, polyolefin made of polyethylene, polypropylene, etc. is preferred because it is low cost and the pore diameter can be controlled in various ways. In addition, water-insoluble hydrophilic polymers are copolymers obtained by polymerizing hydrophobic monomers and hydrophilic monomers, and those with a hydrophilic monomer content of 40 to 90% by weight are good for performance development. preferable. Among these, a plasma separation membrane in which the copolymer is polyethylene/vinyl alcohol and the polyolefin is polyethylene is the most preferred because of its high performance.

When a physiologically isotonic solution is pre-filled in the membrane plasma separator used in the present invention, the outlet of the membrane plasma separator should be closed with a seal as described above until just before use to prevent it from flowing downstream. Place it like this.

When using the plasma collection unit of the present invention, first, the blood return tube part connected to the blood pool is primed with a physiological solution such as physiological saline, air is expelled, and then a blood collection needle is inserted into the blood pool to completely remove the blood. Collect blood. At this time, the blood is mixed with the anticoagulant in the blood collection bag, and the blood is anticoagulated. The blood is then introduced into a membrane plasma separator by breaking a seal downstream of the blood collection bag that allows fluid flow, and the plasma is separated and collected in a plasma bag. In addition, the blood with a high concentration of blood cells from which plasma has been removed may be collected in a bag and then returned to the blood pool. It is also possible to directly return the blood to the blood pool, which is preferable because the time required to puncture the blood pool can be shortened.

Upon exiting the membrane plasma separator, the cell-enriched blood first enters means for removing air bubbles. This allows the use of what is generally called an air chamber, which can remove air bubbles in the returning blood, and which connects the tube and membrane plasma separator from the seal to the means for removing air bubbles. If the capacity is larger than the amount of air present in the area, it can be used without any problem.

Here, the blood with a high concentration of blood cells from which air bubbles have been removed is sent through a blood return tube into a blood collection tube that connects the blood collection needle and the blood collection bag, and is returned to the blood pool.

A tube for flowing the physiological solution used for priming can be attached to an appropriate separation of this unit, but if the returned blood containing concentrated blood cells is to be diluted with this physiological solution, this tube should be installed. When connected immediately before, directly into, or immediately after the means for removing air bubbles, it is possible to dilute the blood containing concentrated blood cells, lowering the resistance during blood return and allowing smooth plasma collection. , which is preferable because the blood return time is shortened. Furthermore, it is preferable to attach the priming tube at the above position because it is easy to prime only the blood return tube portion and expel air without priming the membrane plasma separator. In addition, by priming only the blood return tube, plasma can be collected without wetting the membrane plasma separator with saline, etc.
Dilution of the obtained plasma can be prevented, and plasma with high protein concentration can be collected.

Physiological solutions such as physiological saline used for priming and blood return may be introduced into this unit by using a bag separate from this unit and inserting a needle into it; It is also possible to pre-connect to this unit via a seal that allows circulation, further improving the closure of the unit.

When collecting plasma from a blood pool using the unit of the present invention as described above, first attach the unit to an appropriate position, prime only the tube part connected to the blood pool with physiological saline, and perform puncture and blood collection. Do the following. At this time, if blood is collected using only the drop, place the blood collection bag at an appropriate position below the blood pool and collect by weight. Further, a so-called suction blood collector, which collects blood by reducing the pressure on the outside of a blood collection bag, is often used in blood collection vehicles, and it is of course possible to use this. It is also possible to use a tourniquet.

Compared to the conventional method of collecting whole blood into a blood collection bag through a membrane-type plasma separator, the method of directly collecting whole blood from the blood pool to the blood collection bag of the present invention, which has no passage resistance, can achieve a high blood collection rate, resulting in a high blood collection rate. Plasma collection rate is obtained. That is, a large amount of plasma can be obtained in a short period of time.

In this way, the unit of the present invention can be implemented without using any special machinery or equipment;
In addition, a blood sampler that is commonly used even today can be used when collecting blood. However, the subsequent plasma collection and blood return operations are all based on the drop, and can be performed even without power. However, if it is necessary to suppress the flow velocity, this can be done by holding down the tube with a roller clamp, etc. Furthermore, if acceleration of the flow rate is required, a blood pump normally used in artificial dialysis etc. can be placed upstream of the membrane plasma separator.

The plasma collection unit of the present invention is an extremely closed unit that is isolated from the outside air and has only the blood collection needle or the blood collection needle and the physiological saline introduction needle as open ends. The plasma separator, means for removing air bubbles, etc. are integrally connected via tubes between each member as necessary, and similarly, the plasma separated by the membrane type plasma separator can be separated. The plasma bag for storage is also connected to this unit.

The unit in which each member is integrated and connected as described above is sterilized and sealed in a bag to complete the plasma collection unit of the present invention. In addition, the length of the tube connecting each member is determined to be a length that allows a desirable head to be achieved during use and does not require much effort in operation. Further, tubes connecting various parts are made of polyvinyl chloride resin, which is well known for use in blood circuits. The tube connecting each part may be flexible, but it is best to use a rigid tube with a length that provides a suitable head height, and to provide bends at various locations on the tube, and to fold it compactly before use. It is also possible to provide a device in which each member is placed in a preferred position during use.

The membrane type plasma separator used in the present invention is not particularly limited as described above, but particularly preferred is a membrane type plasma separator with a small size and high separation capacity as described in Japanese Patent Application No. 62-329467. Examples include separators.

(Embodiments) Next, embodiments of the present invention will be described with reference to the drawings. This device is for collecting plasma components from a blood pool. FIG. 1 shows an embodiment of the present invention sterilized in a bag 20, and FIG. 2 shows its use. In use, the unit is removed from the bag, the unit is mounted on a suitable support with appropriate head clearance, and the blood return line is primed. First, the cap 16 attached to the physiological saline introduction needle 13 is removed, and the physiological saline introduction needle is inserted into the physiological saline bag 21. Next, the roller
Clamps 18 and 17 are loosened and saline is filled into tube 12, means for removing air bubbles 11, blood return line 14, etc. and air is expelled. After priming, temporarily tighten the roller clamp to prevent saline from leaking.

Next, the blood collection needle 1 is punctured into the brachial vein of the plasma donor, and an appropriate amount of whole blood is collected by loosening the roller clamp 19 and destroying the seal 3 that allows fluid to flow. do. When collecting blood, place the blood collection bag at a lower position than the blood pool to provide an appropriate height, or collect blood with a suction blood collector or the like.

Blood collected through tube 2 enters blood collection bag 4. When collecting 400 ml of whole blood, the blood collection bag contains approximately 46 ml of hypercoagulant when using CPD. Normal 400ml whole blood collection
Although 56 ml of CPD is used, the remaining approximately 10 ml is stored in the membrane plasma separator 7 in this unit.

When the blood collection is completed, the roller clamp 19 is tightened, and the anticoagulated blood is introduced into the membrane plasma separator 7 through the tube 6 by breaking the seal 5, which allows the flow of liquid. . The plasma separated here passes through a tube 8 and is collected into a plasma bag 9. Further, the blood cell-enriched blood from which plasma has been removed passes through the tube 10 and enters the means 11 for removing air bubbles, and by loosening the roller clamp 17 passes through the blood return tube 14 from the blood collection tube 2 through the blood collection needle. blood is returned to the blood pool through the At this time, it is preferable to loosen the roller clamp 18 slightly and drip physiological saline to dilute the concentrated blood and reduce the resistance through the tube or blood collection needle, allowing blood to be returned smoothly.

In the membrane-type plasma separator 7, for example, a porous membrane obtained by melting and stretching high-density polyethylene is coated with a polyethylene/vinyl alcohol copolymer on the membrane pore surface and subjected to a hydrophilic treatment. It also contains a hydrophilic composite porous membrane with a membrane area of approximately 1500 cm ² obtained by bundling 840 hollow fiber membranes with an inner diameter of 300 μm, a membrane thickness of 40 μm, and an average pore diameter of 0.2 μm as measured by the bulb point method. , 10ml in the membrane pore area
It is preferable to use one containing CPD liquid.

In addition, it is possible to fill the blood collection bag with sterile air, and in this case, this air can push out the blood remaining in the membrane plasma separator, eliminating the need for collection with physiological saline. It is convenient because it can be done.

With the above, it takes about 5 to 6 minutes to collect 400ml of whole blood.
The subsequent plasma classification takes approximately 10 minutes, and a total puncture time of approximately 15 to 16 minutes, and approximately 150 to 200 ml of collected plasma can be obtained with an extremely simple operation. In addition, the protein concentration of the collected plasma is very high compared to other methods that use cleaning membrane plasma separators, and the protein recovery rate is low.
Achieved 97% or more.

Furthermore, physiological saline can be dripped into the blood collection needle inserted into the plasma donor at any time, thereby preventing thrombus formation at the needle tip. Furthermore, if a unit containing a plurality of blood collection bags or a unit in which an anticoagulant subbag is connected to a blood collection bag is manufactured, it is possible to collect plasma multiple times.

(Effects of the Invention) Since the unit of the present invention does not use any special machinery or equipment, plasma can be collected in a blood collection vehicle or outdoors. Furthermore, the unit of the present invention is a closed unit in which the constituent members are integrated, only the blood collection needle or the blood collection needle and the physiological saline introduction needle can communicate with the outside, and the entire unit is sterilized. This is a sanitary device with an extremely low possibility of contamination by germs, unlike conventional devices that require assembly by connecting each part before use.

In addition, since the operation can be performed using a drop, there is no possibility of air entering the plasma donor like with a normal intravenous drip, and it can be performed safely without any special safety mechanism.

Furthermore, the unit of the present invention is much easier to prepare, such as priming, than conventional units, is easier to handle, and can yield highly concentrated plasma.

Next, the present invention will be specifically explained using examples.

(Example 1) High-density polyethylene was melted and stretched in accordance with JP-A-61-271003, and then the pore surface of the porous membrane was coated with a polyethylene/vinyl alcohol copolymer and treated to make it hydrophilic. inner diameter
A small membrane plasma separator with an effective length of 20 cm and an effective membrane area of approximately 1600 cm ² was fabricated by bundling 840 hollow fiber membranes of 310 μm, membrane thickness 40 μm, and average pore diameter of 0.2 μm measured by the bubble point method.

The membrane-type plasma separator was once filled with CPD liquid, and then the excess CPD liquid was removed using pressurized air, and approximately 10 g of CPD liquid remained at the time of use. In addition, 46 ml of CPD liquid and 30 ml of air were placed in the blood collection bag, and a 16G blood collection needle was used. Using these, a plasma collection unit was assembled according to Figure 1, placed in a sterilization bag, and sterilized with high pressure steam at 120°C for 20 minutes.

Prior to use, remove the plasma collection unit from the sterile bag and fill chambers 11 and 14 with physiological saline.
The blood return line was filled. Plasma components were collected using adult mongrel dog A (Ht = 46, total protein 6.4 g/d) by puncturing the jugular vein and collecting 400 ml of blood by lowering the blood bag below the dog. After that, raise the blood collection bag and membrane plasma separator upwards, measure 80cm from the puncture site to the bottom of the blood collection bag, and 60cm from the puncture site to the center of the membrane plasma separator, and lower the plasma bag from the membrane plasma separator. It was set to 55cm. As a result, breaking the seal that allows the flow of liquid,
The CPD-enriched whole blood is introduced into a membrane plasma separator, and the plasma that comes out after filtration is stored in a plasma bag.
The plasma-depleted blood was returned to the dog directly from the puncture site.

In this experiment, 180 ml of plasma was collected, the puncture time was 19 minutes, the internal blood collection time was 4 minutes, and the plasma separation time was 13 minutes.
1 min, and 2 min, and the protein concentration of the obtained plasma was 4.95 g/d.

As described above, when using this plasma blood collection unit, there is no need to continuously inject an anticoagulant depending on the amount of blood collected when collecting plasma from a blood pool, and the membrane-type plasma separator can be replaced with physiological saline. This eliminates the need for washing and priming with water, and since no physiological saline is added to the membrane plasma separator, there is no chance of saline contaminating the collected plasma and lowering the protein concentration.

(Comparative Example 1) Plasma collection was performed using the plasma collection unit of Example 1. The difference from Example 1 is that a normal amount of 56 ml of CPD solution was placed in the blood collection bag and that the membrane plasma separator and blood return tube were primed prior to implementation. One month after carrying out Example 1,
It was performed on the same dog (Ht=47, total protein 6.5g/d). As a result, the puncture time was 20 minutes, and the internal blood sampling time was 4 minutes.
The plasma separation time was 14 minutes and the other 2 minutes, and the obtained plasma was 205 ml, with a total protein of 3.8 g/d.
Although the apparent plasma volume increased because the priming solution migrated into the plasma, the total protein was very low.

(Comparative Example 2) The same membrane type plasma separator as in Example 1 was manufactured, and the first
The plasma collection unit shown in the figure was constructed. Example 1
The difference is that the blood collection bag contains 56ml of CPD solution.
In addition, prior to implementation, the membrane plasma separator was washed with physiological saline, and the physiological saline that came out on the filtrate side of the membrane plasma separator was discarded. When the membrane plasma separator is washed with physiological saline in this manner, physiological saline remains inside and outside the hollow fiber membrane. For this reason, the plasma obtained will be diluted if left as is, so by opening the filtrate side to the atmosphere (a sterilizing filter is required to ensure sterility) and by providing a saline disposal line, it is necessary to The saline solution was made disposable. Even with this, the saline still remains inside the membrane, and there is a possibility of bacterial contamination from the saline disposal line.

Two months after carrying out Example 1, this comparative example was carried out on the same dog (Ht=47, total protein 6.5 g/d). Although the preparation operations were quite time-consuming due to the reasons mentioned above, aseptic operations were possible. Puncture time is 20
The blood collection time was 4 minutes, the plasma separation time was 14 minutes, and the other 2 minutes, and there was no significant difference from Example 1 after puncturing. The volume of plasma obtained was 192ml, with a protein concentration of 4.50g/
d was significantly lower than that of Example 1.

(Example 2) The same membrane type plasma separator as in Example 1 was manufactured, and the first
The plasma collection unit shown in the figure was constructed. Example 1
The only difference was the amount of CPD solution in the blood collection bag, which was 40ml. The dog used was a mongrel adult dog B (Ht=
41, total protein 6.2g/d).

In this example, the total amount of CPD was 50 ml, but 180 ml of plasma was collected in about 21 minutes without any problems such as the occurrence of blood clots. The protein concentration of the obtained plasma is
It was 5.00g/d.

(Example 3) The same membrane type plasma separator as in Example 1 was manufactured, and the first
The plasma blood collection unit shown in the figure was constructed. Example 1
The only difference is that the blood collection needle is 18G.
The dog used was an adult mongrel dog C. Plasma was collected in the same manner as in Example 1, but unlike in Example 1, physiological saline was added dropwise at a rate of 8 ml/min to the concentrated red blood cell solution discharged from the membrane plasma separator.

In this example, the blood collection needle was thin, so physiological saline was added to the red blood cells and the blood was returned, so the plasma collection went smoothly, and 175 ml of plasma was obtained in about 25 minutes. For comparison, one month later, an experiment was conducted on the dog used in Example 3 without dripping this saline solution. In this experiment, we were able to collect 165ml of plasma, but the puncture time was
The game was extended to 33 minutes.

[Brief explanation of the drawing]

FIG. 1 is an explanatory diagram showing one embodiment of the device of the present invention. FIG. 2 is an explanatory diagram showing how the device of the present invention is used. 1...Blood collection needle, 2...Blood collection tube, 3...Seal that allows liquid to flow when destroyed, 4...Blood collection bag, 5...Seal that allows liquid to flow when destroyed. 6...Tube, 7...Membrane plasma separator, 8...Tube, 9
... plasma bag, 10 ... tube, 11 ... means for removing air bubbles, 12 ... physiological solution introduction tube, 13 ... physiological solution introduction needle, 14 ...
...Blood return tube, 15...Blood collection needle cap, 16
... Physiological solution introduction needle cap, 17 ... Rotor clamp, 18 ... Rotor clamp, 1
9...Rotor clamp, 20...Bag, 21...
...Saline is the best.

Claims (1)

[Claims] 1 At least, a blood collection needle, a blood collection tube that connects the blood collection needle and the blood collection bag, a blood collection bag pre-filled with anticoagulant, and a blood collection bag that connects the membrane plasma separator,
and a tube with a seal part that allows liquid to flow when broken, a membrane-type plasma separator partially moistened with a physiologically isotonic solution, and a membrane-type plasma separator that separates the plasma. A plasma bag that stores plasma, a tube that connects the membrane plasma separator and the plasma bag, a means for removing air bubbles from the blood cell concentrate that has exited the membrane plasma separator, and a means that connects the membrane plasma separator and a means for removing air bubbles. tube, and a blood return tube for guiding the concentrated blood cell solution that has exited the means for removing air bubbles to the blood collection tube that connects the blood collection needle and the blood collection bag, and each of these components forms an integrated closed extracorporeal circulation circuit. 1. A plasma collection unit characterized in that the plasma collection unit is formed and sterilized in one bag.