JPH0747303A - Centrifugal separation device and centrifugal separation method for blood bag unit with filter for removing leukocyte - Google Patents

Abstract

PURPOSE:To provide a method and device to easily attach a bag unit having a filter for removing leukocytes to a centrifugal separation device and to perform centrifugal separation without damaging the unit. CONSTITUTION:This device is equipped with a rotor 2 fixed to a rotating shaft 1 and having two or more arms 2 which are extended in a point symmetry and rotate with the shaft 1, a bucket 3 to house a blood bag pinched with a pinching means on the top end of each arm of the roter 2 in such a manner that the bucket can swing in the centrifugal direction, and a fixing means 5 for the filter for removing leukocytes. The fixing means 5 is disposed on the rotor 2 in the position nearer to the shaft than the distance from the shaft to the center of the bucket 3.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a method and apparatus for centrifuging blood collected in a blood collecting bag or the like which constitutes a blood bag unit with a leukocyte removal filter.

[0002]

2. Description of the Related Art In recent years, it has been clarified that post-transfusion side effects are induced by contaminated leukocytes in blood products with the progress of immunology and transfusion science. It has become common to remove leukocytes in blood for transfusion in advance using a filter containing a non-woven fabric, a porous body, or the like. Further, recently, blood for transfusion is not limited to whole blood, and there is a great demand for component-specific blood such as red blood cell concentrate, plasma, and platelet concentrate. Therefore, blood for transfusion (blood product) is required to be component-specific blood from which white blood cells have been removed. These component-specific bloods are obtained by removing leukocytes from whole blood collected from a donor and further centrifuging, but these series of operations must be performed aseptically and promptly.

As a blood bag unit with a leukocyte removal filter used for this operation, US Pat.
596657 and U.S. Pat. No. 4,985,153 are known. These are blood bags made of a flexible material such as vinyl chloride, and a leukocyte removal filter in which a filter material made of a non-woven fabric or a porous body is contained in a relatively hard container made of polycarbonate or the like, and flexible such as vinyl chloride. It is connected in a liquid-tight manner by various tubes and is called a closed system.

When the blood collected in the blood bag in the closed system is separated while maintaining the sterility, the whole integrated system has to be centrifuged.

The centrifugal separator used for separating blood is
Normally, as shown in FIG. 9, next to a rotor 2 having six horizontally extending arms 2 having rotor pins 4 provided on both side surfaces of a tip portion, which is installed on a rotating shaft 1 extending in the vertical direction, The blood containing bucket 3 is held between the rotor pins 4 provided on each of the two matching arms. Rotor at rest before centrifugation
The bucket 3 which has been hung vertically between the two arms 2 in the vertical direction, that is, the vertical direction, is substantially horizontal to the arm 2 while being held by the rotor pin 4 by centrifugal force during the centrifugal separation operation. And rotate.

[0006] Since the leukocyte removal filter containing the filter material made of non-woven fabric or porous material has a very delicate structure, it is bundled together with flexible blood bags and tubes connecting them, and the centrifuge is separated. When packed in a bucket and subjected to centrifugation, the composition such as the bulk density of the non-woven fabric of the leukocyte removal filter and the pore diameter of the porous body will change due to the strong centrifugal force, and in some cases, the leukocyte removal filter will gradually move into the bucket due to centrifugal force. There is a risk that the whole leukocyte removal filter may be damaged or the tubes may be cut off by being pressed against the bottom of the.

The bucket of the centrifuge represented by FIG. 9 was originally designed for loading a blood bag system consisting of only flexible components such as blood bags and tubes connecting them. In addition to the flexible components, it is difficult to load a closed system that has a leukocyte removal filter built into a relatively hard container, and the loading operation is difficult and time-consuming. The unit may be damaged during this.

US Pat. No. 5,100,564 discloses a protection jig for receiving a centrifugal force applied to a leukocyte removal filter at the peripheral edge of the upper end opening of a bucket in order to prevent such damage. This protection jig is fitted to the peripheral edge of the upper opening of the bucket, and is provided on the side surface of the filter so that the flat discoid leukocyte removal filter is fixed to the upper part of the bucket perpendicularly to the depth direction of the bucket. A groove is provided for fitting the existing blood nozzle. If this jig can be used in practice, the leukocyte removal filter will receive centrifugal force at the upper end of the bucket, so the leukocyte removal filter will experience less centrifugal force than if the leukocyte removal filter were placed in the bucket. Therefore, it is preferable.

However, in the above example, the size of the bracket has to be redesigned each time according to both the opening diameter of the bucket and the shapes of the inlet nozzle and the outlet nozzle of the leukocyte removal filter, which lacks versatility. There are various buckets on the market, such as a cylindrical shape, an oblong shape, and a shape in which two long cylinders are joined together.
There are various sizes. There are various types of leukocyte removal filters that are commercially available, such as a disk-shaped one that has an inlet nozzle and an outlet nozzle on each side, a square plate, an oval plate that has an inlet nozzle and an outlet nozzle at both ends, and so on. .

Further, since each blood bag loaded in the bucket usually has a total length including the tube portion connected to the upper portion longer than the internal height of the bucket, the upper portion of the blood bag protrudes when loaded in the bucket. Is normal. Therefore, the bracket is pushed up by the protruding upper part of the bag, and in many cases, the bracket cannot be stably fitted in the upper end of the opening of the bucket. Since the bracket that has been pushed up may come off when centrifugal force is applied or fall into the bucket, it is not possible to perform centrifugal separation operation as it is. Also, if the bracket is forcibly pressed against the opening of the bucket with adhesive tape, the joint between the tube on the top of the bag and the bag body may be damaged, and the time and effort of forcibly fixing the bag are difficult. is there.

[0011]

DISCLOSURE OF THE INVENTION According to the present invention, when centrifuging blood collected in a blood collection bag or the like constituting a blood bag unit with a leukocyte removal filter, the blood bag unit with a leukocyte removal filter is installed in a centrifugal separator. Easy and fast loading, yet reduce the centrifugal force on the leukocyte depletion filter to centrifuge without damaging the leukocyte depletion filter, easy removal of the unit after centrifugation and no remixing of separated blood The purpose is to do so.

[0012]

According to the present invention, a blood bag unit with a leukocyte removal filter, in which at least a leukocyte removal filter and flexible blood bags are liquid-tightly connected by tubes, is sealed in the bag. And a centrifugal separator for separating blood components by centrifugal operation, wherein the centrifugal separator is at least a rotating shaft, and two or more arms fixed to the rotating shaft and extending in point symmetry to rotate with the rotating shaft. A blood bag containing bucket held by the tip of the rotor so as to be swingable in the centrifugal direction by a holding means provided at each arm tip of the rotor, and a fixing means for the leukocyte removal filter, and the white blood cell The fixing means of the removal filter is arranged such that the rotation shaft is closer to the rotation shaft than the distance between the rotation shaft and the center of the bucket. It is provided in a portion of a centrifugal separator of the blood bag unit with leukocyte-removing filter according to claim.

According to the present invention, a blood bag unit with a leukocyte removal filter, in which at least a leukocyte removal filter and flexible blood bags are connected to each other in a liquid-tight manner by tubes, is centrifugally operated while the blood is sealed in the bag. A centrifugal separator for separating blood components by applying at least a rotating shaft,
A rotor that is fixed to the rotating shaft and rotates; a gripping means for the blood bag containing bucket provided on the rotor; and a fixing means for the leukocyte removal filter, and the fixing means for the leukocyte removal filter is provided on the rotating shaft. On a dedicated flat plate that is pivotally supported and arranged above the rotor to rotate,
A centrifugal separator for a blood bag unit with a leukocyte removal filter, wherein the centrifugal separator is provided at a position closer to the rotation axis than a distance to the center of the bucket.

In the present invention, further, a blood bag unit with a leukocyte removal filter, in which at least a leukocyte removal filter and flexible blood bags are connected in a liquid-tight manner by tubes, is subjected to a centrifugal operation while the blood is sealed in the bag. At the time of separating blood components, a bag containing blood to be separated is loaded into a blood bag storage bucket of the centrifugal separator, and the filter is pulled out of the bucket while the tubes are connected, and a rotary shaft of the centrifugal separator. The method for centrifuging is characterized in that the blood component is separated by fixing to a rotating body pivotally supported at a position between the rotating shaft and the center of the bucket.

In the present invention, the distance between the rotary shaft and the center of the bucket means the distance between the rotary shaft and the gripping means of the bucket. When referring to the distance between the leukocyte removal filter or its fixing means and the rotation axis, the reference point for measuring the distance on the leukocyte removal filter or its fixing means is the center of symmetry of the container except the blood inlet / outlet nozzle in the leukocyte removal filter. In the means for fixing the leukocyte removal filter, it means the symmetrical center of the container excluding the blood inlet / outlet nozzle of the leukocyte removal filter when the leukocyte removal filter is fixed thereto.

In the present invention, at least the blood bag containing the blood to be separated is loaded into the bucket so that an appropriate centrifugal force is exerted, and at least the leukocyte removal filter is provided outside the bucket, either on the arm of the centrifuge or on the other side. It is fixed to a flat plate-shaped rotating body provided with a fixing means separately provided for exclusive use. Other components of the blood bag unit with a leukocyte removal filter can also be pulled out of the bucket and fixed to a site where centrifugal force is reduced like the leukocyte removal filter.

In the centrifuge of the present invention, the position where the leukocyte removal filter is fixed is substantially parallel to the arm when a centrifugal force is applied, as well as when the centrifuge is not driven. It goes without saying that it is determined in consideration of the distance that does not allow the blood bags and the leukocyte removal filter loaded in the upper opening end of the rotating bucket or the inside thereof to come in contact with each other. The position where the leukocyte removal filter is fixed is preferably as close to the rotation axis as possible because the centrifugal force applied to the leukocyte removal filter becomes smaller as it is closer to the rotation axis.

[0018]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The centrifuge and the centrifuge method of the present invention will be described in detail below with reference to the drawings.

1 and 2 show a first embodiment of the centrifugal separator according to the present invention. In the first embodiment,
When centrifuging, first, among the components of the blood bag unit with a leukocyte removal filter, the flexible blood bag and the tube portion a are overlapped in the same manner as the conventional blood bag and the blood bag system consisting of only tubes, and the blood bags are separated in the centrifugal direction. The bucket 3 held vertically by the rotor pin 4 of the centrifugal separator is placed parallel to
Only the leukocyte removal filter part b, which is integrally connected to the bags through the tube of the book, is pulled out together with a part of the tube to the outside of the bucket. If a chamber or clip is provided in the middle of the tube, put them in the bucket 3 as well. It is preferable to load a blood bag containing blood and a bag containing a drug into the bucket 3 by stacking them with an empty bag so as to cover them. Tubes should be bundled and rolled within a comfortable range, and appropriately sandwiched between blood bags. Since the connecting portion between the blood bag and the tube provided on the upper portion of the blood bag is a portion that is particularly susceptible to damage, it should be exposed to the upper opening side of the bucket as much as possible so as not to contact the wall of the bucket.

The leukocyte removal filter pulled out from the bucket 3 through the two tubes is placed in the leukocyte removal filter fixing means 5 provided at a position between the two arms 2 near the rotation axis of the rotor 2. insert. The leukocyte removal filter fixing means 5 is a flat pocket-shaped member having a structure in which the centrifugal force applied to the flat leukocyte removal filter is supported by the side portion of the filter, and the rotor is composed of two columns 7 standing at the root of the arm 2. It is locked on the upper part of 2 . The fixing means 5 can be provided directly on the upper portion of the rotor 2 , but as shown in FIG. 2, it is also preferable that the fixing means 5 be spaced apart from the blood bags in the bucket at the same height. Also, the fixing means 5 is
The blood bag unit with the leukocyte removal filter is arranged on a straight line connecting the bucket and the rotation shaft with the blood bags loaded therein. This arrangement prevents the tube connecting the leukocyte removal filter and the blood bags in the bucket from being bent at an acute angle and damaged even if the tube is subjected to centrifugal force during the centrifugation operation.

Rotor of white blood cell removal filter fixing means 5
2 The fixing position to the upper surface may be not only the root of the arm 2 as described above but also a state of straddling the two arms 2 as in the second embodiment of FIGS. 3 and 4. In the case of this embodiment, the bucket 3 is a twin type, and two sets of blood bag units with a leukocyte removal filter can be loaded in one bucket 3. In this embodiment, the two leukocyte-removing filters use the fixing means 5 that can be fixed by stacking them in the upper and lower two stages.

FIG. 5 shows a white blood cell removal filter fixing means 5
In the third embodiment, the leukocyte removal filter b is directly placed on the arm 2 of the rotor 2 and fixed with the adhesive tape 5'without using a dedicated jig. This example is preferable in that the existing centrifugal separator for blood can be used as it is and that it can be easily fixed regardless of the shape of the leukocyte removal filter. However, in this example, since the fixed position of the leukocyte removal filter b is not in a straight line connecting the rotating shaft of the centrifugal separator and the bucket loaded with the blood bag a of the blood bag unit with the leukocyte removal filter, Care must be taken in arranging the tubes so that the tubes connecting to the blood bags in the bucket will not be bent sharply when subjected to centrifugal force during centrifugation.

Further, the adhesive tape 5'for fixing the leukocyte removal filter is troublesome to remove, and
It is also possible to use a rubber belt or the like instead, since there is a possibility that the dust of the tape or the like remains on the leukocyte removal filter.
In any case, when fixing with a strip,
The winding method is appropriately devised so that the leukocyte removal filter does not slide on the arm 2 of the rotor 2 in the centrifugal direction by the centrifugal force during the rotation of the rotor.

FIGS. 6 and 7 show a fourth embodiment of the centrifuge according to the present invention. In this example, the upper portion of the rotor 2, a flat plate 6 which leukocyte-removing filter fixing means 5 is provided on the same number radially and bucket 3 to rotate the rotor 2 coaxially with, are spaced parallel to the rotor upper plane .
Leukocyte removal filter fixing means 5 arranged on the flat plate 6
Is for a flat filter similar to the above-mentioned example, and locking portions 9 for supporting the centrifugal force applied to the filter at the side portions of the filter are provided at the circumferential end of the flat plate 6 at equal intervals as the bucket 3. In addition, a pair of claws 8 for preventing the filter from being displaced in a direction perpendicular to the centrifugal direction that can be placed on the flat plate 6 is provided at portions corresponding to both sides of each filter. The pair of claws 8 may have a structure in which the width between which the filter is sandwiched can be selected by sliding to some extent so that it can be applied to a leukocyte removal filter of any size.

In this embodiment, it is sufficient to fix the disk-shaped flat plate 6 to the rotary shaft 1 without making any modifications to the rotor of the existing centrifugal separator, so that the centrifugal separator is highly versatile and the surface of the rotor is high. Since there is no protrusion on the, it does not interfere with the operation.

Although the flat plate 6 is a single plate in the examples of FIGS. 6 and 7, the shape of the flat plate 6 to which the leukocyte removal filter fixing means 5 is fixed is such that the leukocyte removal filter can be stably fixed. If so, for example, it may consist of only radial arms similar to the rotor as shown in FIG. The flat plate 6 having a small area for covering the upper surface of the rotor as in the example of FIG. 8 has an advantage that it is difficult to get in the way due to the arrangement relationship with the bucket.

As another embodiment of the centrifuge of the present invention, in addition to the example in which the leukocyte removal filter is fixed on or above the rotor as described above, a groove portion for inserting the leukocyte removal filter is provided on the arm itself of the rotor. It is also possible to provide a fastener or the like for fixing the leukocyte removal filter that is provided and inserted as necessary, and use it as a leukocyte removal filter fixing means. The groove for inserting the leukocyte removal filter is preferably provided parallel to the rotation axis in order to make the centrifugal force applied to the leukocyte removal filter as uniform as possible, but it is necessary to maintain the strength of the arm itself. If considering also, it is better to provide the arm along the longitudinal direction of the arm. In any case, the embodiment in which the groove for inserting and fixing the leukocyte removal filter is provided in the arm is suitable when the leukocyte removal filter to be fixed is flat and relatively small.

When a plurality of blood bag units with leukocyte removal filters are fixed to the centrifuge by considering the weight balance when the rotor is rotating as in the above embodiment, the switch is turned on to centrifuge the blood in the blood bag. . The rotation time and the rotation speed are appropriately selected from the usual blood separation conditions.

When the blood separation is completed, first, the fixed leukocyte removal filter part is removed from the device, and then the blood bags in the bucket are gently pulled out.

In the present invention, since the centrifugal force applied to the leukocyte removal filter during centrifugation is considerably strong, if the contact area between the leukocyte removal filter and the engaging portion of the leukocyte removing filter fixing means is small, the leukocyte removal will occur at the engaging portion. The pressure exerted on the filter is extremely large and it is easy to damage it. Therefore, to protect the leukocyte depletion filter, wrap the leukocyte depletion filter with a non-woven fabric or sponge that has a shock-relieving effect and then sandwich it in the locking part, or a rubber or urethane material that has a shock-reducing effect in advance in the locking part. It is preferable that a member made of is provided so that the leukocyte removal filter is brought into contact with as many surfaces of the locking portion as possible, and centrifugal force is applied while the leukocyte removal filter is protected.

The centrifuge and the centrifuge method of the present invention have been described above focusing on the embodiment having a unit having a flat leukocyte removal filter. However, the shape of the leukocyte removal filter to which the present invention is applied is the flat shape described above. Not only the shape but also a cylindrical shape can be applied.

[0032]

According to the centrifugation method of the present invention, the distance from the center of rotation to the leukocyte removal filter is smaller than that in the case where the leukocyte removal filter is fixed in or on the bucket together with the flexible blood bag or the like. Therefore, the centrifugal force applied to the leukocyte removal filter is small,
Therefore, the leukocyte removal filter is less likely to be damaged. Also,
Since it is not necessary to force the leukocyte removal filter together with the blood bag into the bucket, not only is it easy to load the blood bag into the bucket, but blood is removed at the corners of the hard container of the leukocyte removal filter. There is no fear that the bags will be damaged. Furthermore, the operation of removing the blood bag unit with the leukocyte removal filter from the centrifuge is easy after the centrifugation is completed, and the separated blood is mistakenly mixed again when the bag containing the separated blood is taken out from the bucket. The possibility is extremely low.

[Brief description of drawings]

FIG. 1 is a top view of a first embodiment of a centrifuge.

FIG. 2 is a side view of the first embodiment of the centrifuge.

FIG. 3 is a top view of the second embodiment of the centrifuge.

FIG. 4 is a side view of a second embodiment of the centrifuge.

FIG. 5 is a perspective view of a third embodiment of the centrifuge.

FIG. 6 is a top view of the fourth embodiment of the centrifuge.

FIG. 7 is a side view of the fourth embodiment of the centrifuge.

FIG. 8 is a perspective view of a fifth embodiment of the centrifuge.

FIG. 9 is a perspective view showing a part of a rotating part of a general centrifuge for a blood bag system.

[Explanation of symbols]

1 Rotating Shaft 2 Rotor 2 Arm 3 Bucket 4 Rotor Pin 5 Leukocyte Removal Filter Fixing Means 5'Adhesive Tape 6 Flat Plate 7 Support 8 Claw 9 Locking Part a Blood Bag b Leukocyte Removal Filter

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[Procedure amendment]

[Submission date] May 23, 1994

[Procedure Amendment 1]

[Document name to be amended] Statement

[Name of item to be corrected] Claim 5

[Correction method] Change

[Correction content]

[Procedure Amendment 2]

[Document name to be amended] Statement

[Name of item to be corrected] Claim 6

[Correction method] Change

[Correction content]

[Procedure 3]

[Document name to be amended] Statement

[Correction target item name] 0013

[Correction method] Change

[Correction content]

According to the present invention, a blood bag unit with a leukocyte removal filter, in which at least a leukocyte removal filter and flexible blood bags are connected to each other in a liquid-tight manner by tubes, is centrifugally operated while the blood is sealed in the bag. A centrifugal separator for separating blood components by applying at least a rotating shaft,
It is fixed to the rotary shaft and extends in a point symmetry that rotates with the rotary shaft.
Rotor having two or more arms and each arm of the rotor
Gripping means provided at the tip of the shaft, and the fixing means of the leukocyte removal filter is rotatably supported by the rotating shaft and is disposed above the rotor. A centrifugal separator for a blood bag unit with a leukocyte removal filter, characterized in that it is provided at a position closer to the rotation axis than a distance.

Claims (12)

[Claims] 1. A blood bag unit with a leukocyte removal filter, wherein at least a leukocyte removal filter and flexible blood bags are connected in a liquid-tight manner by tubes, and a blood component is subjected to a centrifugal operation while blood is sealed in the bag. And a rotor having at least a rotating shaft, two or more arms that are fixed to the rotating shaft and extend in point symmetry that rotate together with the rotating shaft, and each of the rotors. A blood bag storage bucket gripped by the gripping means provided on the arm tip end to the rotor tip end so as to be swingable in the centrifugal direction, and a fixing means for the leukocyte removal filter, and the fixing means for the leukocyte removal filter is the rotating member. It is provided at a portion of the rotor closer to the rotating shaft than the distance between the shaft and the center of the bucket. A centrifuge for a blood bag unit with a leukocyte removal filter. 2. The centrifuge according to claim 1, wherein the means for fixing the leukocyte removal filter is provided at a portion of the rotor located on a straight line connecting the rotating shaft and the center of the blood bag containing bucket. 3. The centrifuge according to claim 1, wherein the means for fixing the leukocyte removal filter is provided on the upper surface of the rotor. 4. The centrifuge according to claim 1, wherein the means for fixing the leukocyte removal filter is provided inside the rotor. 5. A blood component comprising a blood bag unit with a leukocyte-removing filter, which comprises at least a leukocyte-removing filter and flexible blood bags connected to each other in a liquid-tight manner by tubes, and is subjected to a centrifugal operation while blood is enclosed in the bag. A centrifuge for separating blood, wherein the centrifuge comprises at least a rotating shaft, a rotor fixed to the rotating shaft to rotate, a gripping means for a blood bag containing bucket provided on the rotor, and the white blood cell. A fixing plate of a removal filter, and a fixing plate of the leukocyte removal filter is rotatably supported by the rotating shaft, is disposed above the rotor, and is disposed on an exclusive flat plate that rotates, Centrifugation of a blood bag unit with a leukocyte removal filter, which is provided at a position close to the rotation axis Separation device. 6. The centrifuge according to claim 5, wherein the means for fixing the leukocyte removal filter is provided at a portion of the rotor located on a straight line connecting the rotating shaft and the center of the blood bag containing bucket. 7. A blood bag unit with a leukocyte-removing filter, in which at least a leukocyte-removing filter and flexible blood bags are connected to each other in a liquid-tight manner by tubes, are subjected to a centrifugal operation while the blood is sealed in the bag to remove blood components. At the time of separation, a bag containing the blood to be separated is loaded into the blood bag storage bucket of the centrifugal separator, and the filter is pulled out of the bucket with the tubes connected, and is rotatably supported by the rotary shaft of the centrifugal separator. A method for centrifuging, characterized in that the blood component is separated by being fixed to the rotating body at a position between the rotating shaft and the center of the bucket. 8. The centrifugal separation method according to claim 7, wherein the rotating body is a rotor having two or more arms which are fixed to the rotation shaft and extend in point symmetry so as to rotate together with the rotation shaft. 9. The method for centrifuging according to claim 8, wherein the leukocyte removal filter is fixed to the upper surface of the rotor located on a straight line connecting the rotating shaft and the center of the blood bag containing bucket. 10. The centrifugation method according to claim 8, wherein the leukocyte removal filter is fixed inside the rotor located on a straight line connecting the rotation shaft and the center of the blood bag containing bucket. 11. The flat plate, which is arranged above the rotor and rotates at the same angular velocity as the rotor.
Centrifugation method. 12. The centrifugation method according to claim 11, wherein the leukocyte removal filter is fixed to a flat plate upper surface located on a straight line connecting the rotating shaft and the center of the blood bag containing bucket.