JPH06254153A - Separation of blood component - Google Patents

Abstract

PURPOSE:To provide a method for separating the blood component by using a leucocyte removing filter protecting body which hardly generates the breakage of a leucocyte removing filter, bags, etc., in the case where the bag of a bag unit including the leucocyte removing filter is accommodated into a centrifugal cup and the centrifugal separation is carried out. CONSTITUTION:As for a blood component separating method, the bag 3 of a bag unit which is formed by connecting at least a leucocyte removing filter 1, blood taking bag and a bag for seoarated blood in a liquidtight form by a tube is accommodated into a centrifugal cup 4, and the leucocyte removing filter is placed horizontally on a centrifugal cup opened port surface. In carrying out centrifugal separation, a protecting body 2 is interposed between the leucocytes removing filter 1 and the bag 3, and the centrifugal force applied to the leucocyte removing filter is supported by the bag.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a blood component separation method for centrifuging blood using a bag unit having a leukocyte removal filter. In detail,
At least the leukocyte removal filter, the blood collection bag, the bag for separating blood and the bag unit consisting of the blood circuit connecting them are inserted into the centrifuge cup, and when the blood is centrifuged, the leukocyte removal filter by centrifugal force, the blood collection The present invention relates to a bag, a blood separation bag, and a blood component separation method using a protective body to prevent damage and damage to a blood circuit.

[0002]

2. Description of the Related Art In recent years, component blood transfusion for transfusion of a blood component that a patient really needs has become widespread from the conventional whole blood transfusion that has been performed with the progress of blood transfusion. Component transfusion is a transfusion of a blood component separated into components such as red blood cells, platelets, and plasma according to the patient's condition, and for that purpose, whole blood must be separated by a method such as centrifugation. The bag unit for separating whole blood into blood components is a closed circuit in which a leukocyte removal filter and a blood collection bag are connected by a tube, and is blocked from the outside air unless the cap part covering the blood collection needle is opened. There is. Further, since the bag unit is previously sterilized by high-pressure steam, it can be used immediately after opening, and there is no fear of contamination or reproduction of microorganisms during storage of blood components.

The separation of blood components is mainly carried out by a conventional centrifugation method, which is a method of separating into various components by utilizing the difference in specific gravity of red blood cells, white blood cells, platelets and plasma in blood. Actually, in a blood center, the blood collection needle of the bag unit is punctured by a donor to collect a certain amount of blood, and then the blood circuit connected to the blood collection needle is welded and closed, and then separated and centrifuged by a centrifuge. The bag unit is placed in a cup and centrifuged to separate a supernatant component and a precipitation component. Then, each or either of the components is introduced into a separated blood bag. When it is necessary to further separate the precipitated component, the necessary blood component and the blood separation bag are stored again in the centrifuge cup, and the same operation is repeated.

US Pat. No. 4,596,657 discloses a blood collection bag in which at least two bags are connected and a leukocyte removal filter is incorporated between the blood collection bag and one of the bags. When the present inventors performed centrifugation of whole blood using this bag unit, if the leukocyte removal filter was placed on the bags and stored in a centrifuge cup, it would not fit well and the leukocytes removed during the centrifugation operation. Sometimes the filter would pop out of the cup. In order to prevent this, it is recommended to fix the leukocyte removal filter to the centrifuge cup with an adhesive tape so as to cover the entire upper surface of the bag unit. However, even with such a method, there are problems that the leukocyte removal filter frequently damages the bags during centrifugation, or the leukocyte removal filter itself collides with the centrifugal cup and is damaged. Further, when the leukocyte removal filter is larger than the inner diameter of the centrifuge cup, the leukocyte removal filter may sink due to centrifugal force and collide with the outer peripheral portion of the upper end of the centrifuge cup to damage the leukocyte removal filter.

US Pat. No. 5,100,564 discloses a protective jig for receiving a centrifugal force applied to the leukocyte removal filter at the outer peripheral portion of the upper end of the centrifugal cup in order to prevent such damage. However, this protection jig must be dimensioned to fit exactly on the outer circumference of the centrifugal cup, and if the dimensions of the centrifuge cup are different, protection jigs of the same size cannot be used and lack versatility. When the protective jig is used, the leukocyte removal filter is fixed on the protective jig and the bags are centrifuged while being stored in the centrifuge cup. Therefore, the bags sink due to centrifugal force and the leukocytes are removed. The tube that connects the filters may be torn. Further, it is recommended that the protection jig is made of a rigid body such as metal, but in the protection jig made of such a material, the leukocyte removal filter is strongly pressed against the protection jig during the centrifugation operation. In addition, there is a risk of damage, and in the case of a protective body made of such a rigid body, when a bag or tube is sandwiched between the protective cup and the centrifuge cup, the tube may be broken or torn.

[0006]

SUMMARY OF THE INVENTION An object of the present invention is to provide a blood component separation method which is less likely to damage the leukocyte removal filter, blood bag and circuit during centrifugation as described above, and is versatile and easy to operate. To provide. The present inventors have completed the present invention as a result of extensive studies to solve the above problems.

[0007]

According to the present invention, at least a bag unit of a bag unit in which at least a leukocyte removal filter, a blood collection bag, and a separated blood bag are connected by a tube is housed in a centrifuge cup, and When the leukocyte removal filter is placed horizontally on the opening surface of the centrifuge cup and centrifuged, a protective body is interposed between the leukocyte removal filter and the bags so that the bags support centrifugal force applied to the leukocyte removal filter. And a method for separating blood components.

In the present invention, the bags support the centrifugal force applied to the leukocyte removal filter because the blood collection bag, the separated blood bag and the circuits inserted in the centrifuge cup as shown in FIG. It means that a protector on which a leukocyte removal filter is placed is placed, and the gravity of the leukocyte removal filter and the protection jig generated during centrifugation is adjusted by a blood collection bag containing blood and a separated blood bag.

When the bags and the like protrude from the upper end of the centrifugal cup, it is preferable to fold the protruding portion. Further, even when it does not stick out, it is preferable to support the protective body with the upper end of the bag folded. That is, it is preferable that the surface of the protective body that contacts the bags be as wide as possible.
By doing this, the gravity generated in the leukocyte removal filter and the protector during centrifugation is widely supported by the folded surface of the bags, the depression of the leukocyte removal filter is suppressed to the minimum, and the bags are subjected to centrifugal force. Makes it less likely to be damaged.

The general shape of the protector used in the present invention is as shown in FIG. The thickness of the protective body is preferably 5 mm or more and 80 mm or less. When a protector is used for the leukocyte removal filter smaller than the inner diameter of the centrifuge cup, it is only necessary to separate the leukocyte removal filter from the bags, and the substantial thickness thereof may be 5 mm to 30 mm. More preferably, it is 10 mm to 20 mm. When using a protector for a leukocyte removal filter that is larger than the inner diameter of the centrifuge cup, it is necessary to prevent contact between the leukocyte removal filter and the centrifuge cup even if the protector sinks into the centrifuge cup due to gravity during centrifugation. Therefore, it is desirable that the thickness is 10 mm to 80 mm,
The thickness is more preferably 20 mm to 60 mm, further preferably 30 mm to 50 mm.

If the clearance between the inner wall of the centrifuge cup and the protector is large, the leukocyte-removing filter on which the protector tilts and tilts up may collide with the centrifuge cup during centrifugation. Therefore, in order to prevent the leukocyte removal filter from moving in the centrifuge cup as much as possible, it is desirable that the protector is in contact with the inner diameter of the centrifuge cup. Furthermore, if the protector is almost in contact with the inner diameter of the centrifuge cup, the bags are unlikely to be caught between the protector and the centrifuge cup. For these reasons, the substantial clearance between the protector and the inner wall of the centrifuge cup is preferably 20 mm or less, and more preferably there is no gap so as to almost contact the inner wall of the centrifuge cup.

At present, most of the centrifugal cups used in Japan and the United States have a cylindrical shape. And most of the diameters thereof are about 90 mm to 110 mm. However, if the diameter is increased even if it is 5 mm, the same thing cannot be used in the case of the protective jig placed on the outer circumference of the centrifugal cup disclosed in US Pat. No. 5,100,564, but the same thing can be used as the protector of the present invention. Things are possible. Therefore, according to the present invention, the same protector can be used in centrifugal cups having different diameters of about 5 mm to 10 mm.
It is much more versatile than the protective jig placed on the outer circumference of the centrifugal cup in No. 4.

The preferred physical properties of the protector used in the present invention are as follows. It is desirable that the material of the protective body that is in contact with the bags be an elastic body. This is because even if the bags are sandwiched between the protective body and the centrifugal cup, if the protective body is made of an elastic body, the bags are less likely to be damaged. The hardness of the elastic body can be measured using a spring type hardness tester described in the section of the hardness test of JIS K6301. With this tester, when the pressure surface is brought into contact with the surface of the test piece, the push needle protruding from the hole in the center of the pressure surface by the spring pressure shows the distance that is pushed back by the rubber surface on the scale as hardness. ing. This tester has A type and C type, and C type hardness tester is A type.
It is suitable for use in a sample having a hardness of about 70 or more. The hardness of the elastic body of the surface of the protective body that contacts the bags is preferably in the range of 10 to 80 degrees when the spring type hardness tester A type is used, and more preferably 1
In the range of 5 to 60 degrees, more preferably 20 to 40 degrees
The range of degrees. Materials having such hardness include natural rubber, synthetic rubber, and foamable rubber, and foamable rubber is the most desirable material.

The surface of the protector in contact with the leukocyte removal filter may be made of a hard material as long as the shape of the filter is well matched and a centrifugal force is applied so that the force is not concentrated at one point. However, it is generally difficult to precisely make a complex uneven surface, so it is desirable to make it with an elastic body like the surface that contacts bags. The preferable hardness of the elastic body on the surface in contact with the leukocyte removal filter is such that the hardness when a spring type hardness tester A type is used is in the range of 10 to 80 degrees, and more preferably 20 to 60 degrees. The range is more preferably 30 to 50 degrees. Materials having such hardness include natural rubber, synthetic rubber, and foamable rubber, and foamable rubber is the most desirable material.

It is desirable that the material for the leukocyte-removing filter and the protector of the substantial thickness portion that does not come into contact with the bags be made of a hard material that is less distorted by centrifugal force. In addition, since the protector is used during centrifugation, it is advantageous that the weight is lighter because the force applied to the bags on the lower side is smaller and the damage is less. Therefore, it is desirable to use a material having a large mechanical strength and a light weight, for example, a hard plastic such as polyacetal, polyamide, polycarbonate, polypropylene or polyurethane.

Furthermore, if a material having an appropriate hardness is used, the entire protective body can be made of a single material. The protective body is located between the surface contacting the leukocyte removal filter or bags and these surfaces. It can be manufactured more easily than when the parts that define the thickness are made of different materials. When the entire protector is made of a single material, its hardness is in the range of 20 to 50 degrees, more preferably 30 to 40 degrees, as measured by the spring type hardness tester A type described in JIS K6301.
It is desirable to be in the range of degrees.

Currently, centrifugal cups used in blood centers generally have a load capacity of up to 1000 g. However, a bag unit with a leukocyte removal filter that collected about 450 ml of blood is about 800g to 85g.
It has a weight of 0 g, and the weight of the protective body must be about 150 g or less. Therefore, US Pat. No. 5,100,564
The protective jig using the rigid metal body disclosed in No. 1 is likely to exceed the weight. However, in the case of the protective body using the elastic body or plastic as in the present invention, although the weight is rarely exceeded, it is preferable that the weight of the protective body itself is light, and therefore foam rubber having pores is preferable as the material. When using a material having a relatively high density, it is preferable to reduce the weight by forming a hole through the surface contacting the leukocyte removal filter and the surface contacting the bags, or by forming a cavity in the substantially thick portion 5.

On the other hand, when the bag unit is centrifuged using the present protector shown in FIG. 2, there is a case where the bag unit is partially sunk in the direction of the rotation axis of the centrifuge cup depending on the centrifugal conditions, the method of inserting the bags and the like. there were. In order to allow the leukocyte removal filter and the protector to sink evenly inside the centrifuge cup, it is necessary to add a protrusion 7 for preventing one-sided sinking as shown in FIG. 3 on the protector surface in contact with the blood collection bag and the blood separation bag. desirable.

In order to prevent the leukocyte removal filter 1 from flying during centrifugation, the main protector 2 on which the leukocyte removal filter is placed
Is set in the centrifuge cup 4 into which the bags 3 are inserted, and then the leukocyte removal filter and the protector are fixed to the centrifuge cup by covering the leukocyte removal filter with an adhesive tape or the like. . However, for the purpose of omitting the operation with the adhesive tape, a part of the substantial thickness portion 5 of the protector or whole blood is made larger than the inner diameter of the centrifuge cup so that it is in contact with the inner wall of the centrifuge cup, and the friction force of the inner wall of the centrifuge cup is increased. It is preferable that the protector equipped with the leukocyte removal filter can be retained and fixed in the centrifuge cup. In this case, it is preferable that the portion in contact with the inner wall of the centrifuge cup is made of an elastic body that can be deformed and pushed during insertion and can press the inner wall of the centrifuge cup with an appropriate pressure after being pushed. The portion in contact with the inner wall of the centrifuge cup is made of an elastic body having a hardness in the range of 15 to 80 degrees when using the spring type hardness tester A type, and more preferably in the range of 20 to 40 degrees. Is.

In order to support the gravity generated in the leukocyte removal filter during centrifugation with the whole blood of the protector and to prevent the damage of the leukocyte removal filter from occurring easily, the filter is placed horizontally on the opening surface of the centrifugal cup and the leukocyte removal filter is placed. It is preferable to make the contact area of the protector as wide as possible. The leukocyte removal filter may have a flat shape or a module shape.

In addition, the position of the leukocyte removal filter on the protector is fixed, and in order to prevent the leukocyte removal filter from falling or coming off during centrifugation, a recess that fits the shape of the leukocyte removal filter and a protrusion that fixes the leukocyte removal filter are provided. A band that attaches to the protective body surface that contacts the leukocyte removal filter, makes the surface that contacts the leukocyte removal filter adhesive, or a band that fixes the leukocyte removal filter,
It is preferable to add a tape.

The blood component separating method using the protector for the blood component separating system of the present invention will be described in more detail with reference to examples.

[0023]

[Example] As a bag unit, four consecutive bags (a blood sampling bag is filled with 63 ml of CPD liquid, and a tube to which a blood sampling needle is connected is taken out from the same direction as SA
A tube connected to a separated blood bag filled with 100 ml of GM appears, and a tube connected to two empty separated blood bags comes out from the opposite direction, OPTIPAC, manufactured by Baxter) SAG-M
The separated blood bag filled with was connected to a circuit in which a leukocyte removal filter and an empty separated blood bag were added. As the leukocyte removal filter 1, Sepacell R-200 (manufactured by Asahi Medical Co., Ltd.) was used. Centrifuge uses Hitachi large capacity cooling centrifuge CR7B3, coater RR5
S2 was used. The centrifuge cup 4 had an inner diameter of about 99 mm and a depth of about 150 mm. The protector 2 has a shape as shown in FIG. 2, and has a diameter of 95 mm and a thickness of 45 m.
m, made of neoprene sponge (hardness of 40 degrees as measured by JIS, K6301 spring type hardness tester A type), and Sepacell R-2 on the surface 6 in contact with the leukocyte removal filter.
No. 00 has a recess with a depth of 3 mm so that one side of the blood inlet nozzle side can be placed exactly.

The blood collection bag of the above bag unit is filled with water 4
50 ml was filled and the blood collection tube was welded and then cut off. Next, as shown in FIG. 1, the blood collection bag and the separated blood bag were bundled together and inserted into the centrifugal cup 4. Bags 3 are 40mm to 50m as they are because they are long
m Although it protruded from the upper end of the centrifuge cup, the protruding part was folded and inserted into the centrifuge cup with as little space as possible. The protective body 2 shown in FIG. 2 with the leukocyte removal filter 1 placed thereon was placed and pushed in from above, and the adhesive tape was attached so as to cover the leukocyte removal filter and fixed to the centrifuge cup. In the same manner, the bag unit was set using protectors in all six centrifuge cups. After combining the weights of the centrifugal cups in symmetrical positions, 500 OR. P. M. (7
It was centrifuged at 300 g) for 10 minutes. After completion of centrifugation, visually check for damage to the bag and circuit, remove the leukocyte removal filter from the bag unit, attach a blind plug to the blood outlet nozzle of the leukocyte removal filter, and then remove 1 kg from the blood inlet nozzle of the leukocyte removal filter. Generation of bubbles due to leak was confirmed in water by sending compressed air of / cm ² . as a result,
In all 6 cases, the bags were not damaged and the leukocyte removal filter was not damaged or leaked.

[0025]

[Comparative Example] When the same bag unit and the same centrifuge were used and set without a protector, the shape of the leukocyte removal filter was slightly larger than the inner wall of the centrifuge cup and the leukocyte removal filter was placed horizontally on top of the bags. The blood inlet nozzle and the outlet nozzle of the leukocyte removal filter were placed on the outer periphery of the upper end of the centrifuge cup. An adhesive tape was attached so as to cover the leukocyte removal filter from above so that the leukocyte removal filter did not jump out from the centrifuge cup. Fifty
0OR. P. M. After centrifuging at (7300 g) for 10 minutes, the states of the leukocyte removal filter and the bags were confirmed. In all 6 cases, the blood inlet nozzle and the outlet nozzle of the leukocyte removal filter were destroyed. Also, all the bags under the nozzle were torn.

[0026]

According to the method for separating blood components of the present invention, damage caused by contact between the leukocyte removal filter and the bags and damage due to contact between the leukocyte removal filter and the centrifugal cup are less likely to occur by this method.

[Brief description of drawings]

FIG. 1 is a cross-sectional view of a state in which a bag unit is inserted into a centrifuge cup using the protector of the present invention.

FIG. 2 is a perspective view showing a general shape of a protector.

FIG. 3 is a perspective view of a protective body having a protrusion for preventing one-sided depression.

[Explanation of symbols]

 1 Leukocyte removal filter 2 Protective body 3 Bags 4 Centrifugal cup 5 Substantially thick portion 6 Surface in contact with leukocyte removal filter 7 Protrusion for preventing sedimentation

Claims (1)

[Claims] 1. A bag unit of a bag unit in which at least a leukocyte removal filter, a blood collection bag, and a separated blood bag are connected in a liquid-tight manner by a tube is housed in a centrifuge cup, and the leukocyte removal filter is centrifuged. A blood component separation characterized in that, when placed horizontally on the opening surface and subjected to centrifugation, a protective body is interposed between the leukocyte removal filter and the bags so that the centrifugal force applied to the leukocyte removal filter is supported by the bags. Method.