Patent Description:
Hitherto, whole blood transfusion in which all the components of blood obtained by blood donation are subjected to transfusion has been the mainstream of blood transfusion. Attendant on the recent progress of technologies, however, blood component transfusion has come to be conducted in which the obtained blood is divided into blood components, such as red blood cells, platelets and plasma, and only the blood component needed by a patient is subjected to transfusion. With blood component transfusion, it is possible to alleviate the burden on the patient's circulatory system and other side effects, and effective utilization of the donated blood is promised.

When subjected to centrifugation, the donated blood is divided into a light supernatant PRP fraction, a heavy sedimentary CRC fraction, and a buffy coat (BC) formed therebetween. The buffy coat contains white blood cells, platelets and red blood cells, and in particular, the platelets include young active platelets in high proportion.

On the other hand, the buffy coat contains white blood cells and therefore cannot be utilized as is. In view of this, it is a common practice to extract only the buffy coat from the centrifuged blood, to subject it again to centrifugation so as to separate the buffy coat into a supernatant liquid and a sedimentary liquid, and further to remove white blood cells from a supernatant liquid by a white blood cell removing filter (see, for example, <CIT> (<CIT>)).

Post-published <CIT> discloses an insert used to receive blood bags, said insert being used in a centrifuge in order to separate blood constituents. The insert has a partition dividing a radially inner blood bag region from a radially outer product region, and a cover arranged in a mounting position above the blood bag region. The cover is connected to the partition in such a way that it can be rotated on a first point and detached on a second point, thereby allowing the blood bag region to be freely accessed by laterally turning the cover away. The insert can be used in the rotor of a centrifuge.

In order to centrifuge a buffy coat into a supernatant liquid and a sedimentary liquid and to transfer the supernatant liquid as mentioned above, it is necessary to perform centrifugation in a former step and to separate (transfer) in a latter step. Accordingly, two special purpose apparatuses are needed therefor, with troublesome operations.

It is preferable that a centrifugation and separation apparatus, which is capable of simultaneously carrying out the two steps, is put to practical use. As such a centrifugation and separation apparatus, a centrifugation means and a separation means (transfer means) may be provided, so that a desired treatment will be carried out by use of a predetermined disposable blood bag system. As for such a blood bag system to be used in the centrifugation and separation apparatus, in general, the following configuration may be considered. The system includes a first bag in which the buffy coat is reserved and in which the buffy coat is centrifuged into a supernatant liquid and a sedimentary liquid, a filter for removing white blood cells from the supernatant liquid transferred by pressing the first bag by a predetermined pressing means, a second bag for reserving the supernatant liquid deprived of the white blood cells by the filter, a first tube for connecting the first bag and an inlet of the filter, a second tube for connecting the second bag and an outlet of the filter, and a first clamp and a second clamp for closing and opening the first tube and the second tube.

In order to mount such a blood bag system in a centrifugation and separation apparatus, however, the first bag, the second bag and the filter must be disposed in appropriate positions, and the first tube, the second tube, the first clamp and the second clamp must be disposed along appropriate paths. This leads to a complicated procedure as well as a fear of mismounting.

The present invention has been made in consideration of the above-mentioned problems. Accordingly, it is an object of the invention to provide a blood bag system and a cassette therefor to be mounted in a centrifugation and separation apparatus for centrifuging a buffy coat obtained from whole blood into a supernatant liquid and a sedimentary liquid and transferring the supernatant liquid, wherein the blood bag system and the cassette can be mounted in the centrifugation and separation apparatus readily and accurately.

The object is solved by an apparatus according to claim <NUM>.

Advantageous developments are subject-matter of the dependent claims.

There is provided a blood bag system including a first bag for reserving whole blood or a blood component, a filter having a filter medium for removing predetermined cells from a blood component obtained by centrifugation of the liquid contained in the first bag, a second bag for reserving a blood component obtained upon removal of the predetermined cells by the filter, a first tube for connecting the first bag and an inlet of the filter, a second tube for connecting the second bag and an outlet of the filter, and a cassette for holding a part of the first tube and a part of the second tube, wherein the cassette has a first clamp section for closing and opening the first tube, and a second clamp section for closing and opening the second tube.

There also is provided a cassette mounted to a multiple bag including a first bag for reserving whole blood or a blood component, a filter having a filter medium for removing predetermined cells from a blood component obtained by centrifugation of the liquid contained in the first bag, a second bag for reserving a blood component obtained upon removal of the predetermined cells by the filter, a first tube for connecting the first bag and an inlet of the filter, and a second tube for connecting the second bag and an outlet of the filter, wherein the cassette holds a part of the first tube and a part of the second tube, and includes a first clamp section for closing and opening the first tube, and a second clamp section for closing and opening the second tube.

Thus, the first tube and the second tube are preliminarily arranged properly in the cassette of the blood bag system, and it is sufficient simply to mount the cassette in a predetermined portion of the centrifugation and separation apparatus. Therefore, the need for intricate laying and arrangement of the first and second tubes, and the need for arranging the first and second clamps are eliminated, whereby mounting of the cassette can be carried out easily and assuredly. In addition, the cassette is equipped with the first clamp and the second clamp, and the clamps are arranged properly in relation to the clamp driving means within the centrifugation and separation apparatus.

The first clamp section and the second clamp section may be configured integrally with the cassette. This makes it possible to simply configure the first clamp section and the second clamp section, and to reduce the number of component parts through integral molding. Naturally, therefore, the operator does not need to mount the first clamp and the second clamp to the cassette, so that the cassette can be mounted easily, thereby reducing the possibility of mismounting.

A configuration may be adopted wherein the first clamp section and the second clamp section each includes a pressing section which can be elastically advanced and retracted, and which presses the first tube or the second tube from a lateral side thereof, an acute-angular engaged portion provided at a tip of the pressing section, a latch section which can be elastically tilted, and an engaging portion which is provided on the latch section and which engages with the engaged portion of the pressing section while in a state of pressing the first tube or the second tube. This enables the first clamp and the second clamp to be simple in configuration.

There is further provided a blood bag system including a first bag for reserving whole blood or a blood component, a filter having a filter medium for removing predetermined cells from a blood component obtained by centrifugation of the liquid contained in the first bag, a second bag for reserving a blood component obtained upon removal of the predetermined cells by the filter, a first tube for connecting the first bag and an inlet of the filter, a second tube for connecting the second bag and an outlet of the filter, a first clamp for closing and opening the first tube, a second clamp for closing and opening the second tube, and a cassette for holding a part of the first tube, a part of the second tube, the first clamp and the second clamp, wherein the cassette has a first clamp operating section for operating the first clamp, and a second clamp operating section for operating the second clamp.

There is also provided a cassette mounted to a multiple bag including a first bag for reserving whole blood or a blood component, a filter having a filter medium for removing predetermined cells from a blood component obtained by centrifugation of the liquid contained in the first bag, a second bag for reserving a blood component obtained upon removal of the predetermined cells by the filter, a first tube for connecting the first bag and an inlet of the filter, a second tube for connecting the second bag and an outlet of the filter, a first clamp for closing and opening the first tube, and a second clamp for closing and opening the second tube, wherein the cassette holds a part of the first tube and a part of the second tube, and includes a first clamp operating section for operating the first clamp, and a second clamp operating section for operating the second clamp.

Thus, the first tube and the second tube are preliminarily arranged properly within the cassette of the blood bag system, and it is sufficient for the cassette to be mounted in a predetermined portion of a centrifugation and separation apparatus. Therefore, the need for intricate laying and arrangement of the first and second tubes, and the need for arranging the first and second clamps are eliminated, whereby mounting of the cassette can be carried out easily and assuredly. In addition, the first clamp and the second clamp are held by the cassette, and therefore the clamps are properly arranged in relation to the clamp driving means within the centrifugation and separation apparatus.

In addition, general-purpose clamp or the like can be utilized as the first clamp and the second clamp. Since the first clamp and the second clamp are preliminarily held properly by the cassette, it is unnecessary for the operator to mount the first clamp and the second clamp onto the cassette. Therefore, the required procedure is easy to carry out, and moreover, there is no possibility of misarrangement.

The first clamp operating section and the second clamp operating section may be configured integrally with the cassette.

The first clamp operating section and the second clamp operating section may each includes a pressing section which can be elastically advanced and retracted, and which presses the first tube or the second tube from a lateral side thereof through the first clamp and the second clamp, an acute-angular engaged portion provided at a tip of the pressing section, a latch section which can be elastically tilted, and an engaging portion, which is provided on the latch section, and which engages with the engaged portion of the pressing section while in a state of pressing the first tube or the second tube through the first clamp and the second clamp. This enables the first clamp operating section and the second clamp operating section to be simple in configuration.

When the first clamp and the second clamp are arranged in parallel with each other within the cassette, a parallel arrangement surface can be utilized effectively, and good balance is secured.

It is preferable that whole blood or a blood component collected from a plurality of donors is reserved in the first bag, and the blood bag system is mounted in a centrifugation and separation apparatus for centrifuging the liquid contained in the first bag into a supernatant liquid and a sedimentary liquid, thereby removing a predetermined component from the supernatant liquid by the filter, and for transferring (separating) the supernatant liquid, deprived of the predetermined component, into the second bag.

A configuration may be adopted in which the centrifugation and separation apparatus includes a first sensor and a second sensor, each of which has a light emitting section and a light receiving section, and which detects the kind of liquid passing between the light emitting section and the light receiving section, the cassette has a sensor hole in which the first sensor and the second sensor are inserted, and the first tube is located so as to pass between the light emitting section and the light receiving section of the first sensor, whereas the second tube is located so as to pass between the light emitting section and the light receiving section of the second sensor. This makes it possible to assuredly detect the liquids present in the first tube and the second tube.

According to the blood bag system and the cassette, the first tube and the second tube are preliminarily arranged properly within the cassette of the blood bag system, and it is sufficient for the cassette to be mounted in a predetermined portion of a predetermined centrifugation and separation apparatus or the like. Therefore, the need for intricate laying and arrangement of the first and second tubes, and the need for arranging the first and second clamps are eliminated, whereby the required mounting can be carried out easily and assuredly. In addition, the first clamp section and the second clamp section are provided in or the first clamp and the second clamp are held in the cassette, so that the clamp sections or clamps are properly arranged in relation to clamp driving means within the centrifugation and separation apparatus or the like.

A blood bag system and the cassette according to the present invention will be described below, in which embodiments thereof are shown and described with reference to the accompanying <FIG>. Only the second and fourth embodiments belong to the present invention. The first and third embodiments are only for illustration.

Blood bag systems 10a, 10b, 10c, 10d and cassettes 50a, 50b, 50c, 50d according to first to fourth embodiments are respectively mounted in a centrifugation and separation apparatus <NUM> for centrifuging whole blood or a blood component (hereinafter, referred to as a buffy coat in the following embodiments) prepared from whole blood into a supernatant liquid and a sedimentary liquid, and for transferring the supernatant liquid. First, the centrifugation and separation apparatus <NUM> will be described. In the following description, the direction of arrow A in <FIG> will be taken as a radial direction, and the direction of arrow B will be taken as a circumferential direction. Strictly speaking, the circumferential direction is the direction along the circular arc, as indicated by arrow B. For convenience of description, however, a direction orthogonal to the arrow A in the location being described will also be referred to as the circumferential direction.

As shown in <FIG>, the centrifugation and separation apparatus <NUM> has a box-like shape, and includes a top cover <NUM> which can be opened and closed, a centrifugal drum (centrifugation means) <NUM> inside the apparatus, six unit insertion holes <NUM> arranged at regular angular intervals (<NUM>°) inside the centrifugal drum <NUM>, six insert units <NUM> inserted respectively in the unit insertion holes <NUM>, and six pressers (pressing means) <NUM> (see <FIG>), which are provided in a central area and which can be advanced and retracted in a rotational radial direction in relation to the insert units <NUM>.

The centrifugation and separation apparatus <NUM> is operated based on operations performed at a console section <NUM> provided at the front of the apparatus. Further, the centrifugation and separation apparatus <NUM> is controlled by a microcomputer (not shown) and can display predetermined information on a monitor <NUM>.

As shown in <FIG>, a central body 14a of the central drum <NUM> has a holding lever <NUM>, which is urged by an elastic body and which holds an end portion of a cassette holder <NUM>, electrodes <NUM>, first rods <NUM> and second rods <NUM>, and a presser <NUM>. The first rods <NUM> and the second rods <NUM> are provided in two pairs, wherein among these rods, the rods on the first circumferential direction B1 side constitute a first clamp driving means 17a for closing and opening a first clamp section <NUM> (see <FIG>), and the rods on the second circumferential direction B2 side constitute a second clamp driving means 17b for closing and opening a second clamp section <NUM> (see <FIG>). The section shown in <FIG> may be configured as a single unit, and six such units may be combined with each other along the circumferential direction.

As shown in <FIG>, the insert unit <NUM> has a unit body <NUM>, a cover body <NUM>, and the blood bag system 10a. The unit body <NUM> is a bottomed tube, which has a wide circular arc shape in top plan view and is open at the top, wherein a small chamber (first chamber) <NUM> on the inner diameter side and a large chamber (second chamber) <NUM> are partitioned from each other by an arcuate wall <NUM>. A buffy coat pooling bag (first bag) <NUM> to be described later is disposed within the small chamber <NUM>, while a platelet preserving bag (second bag) <NUM> and a sampling bag <NUM> are disposed within the large chamber <NUM>. The platelet preserving bag <NUM> has a surface area, which is enlarged for securing appropriate oxygen permeability for the platelets reserved therein, and which is set to be larger than the buffy coat pooling bag <NUM>.

The buffy coat pooling bag (BC pooling bag) <NUM>, the platelet reserving bag <NUM> and the sampling bag <NUM> are each formed, for example, by a method in which flexible sheet members made of a flexible resin such as polyvinyl chloride and polyolefin are laid on each other, and seal portions at the peripheral edges thereof are joined by fusing (heat fusing, high-frequency fusing) or adhesion in order to obtain a bag-formed body.

The small chamber <NUM> opens not only at the top but also on the inner diameter side. A filter pocket <NUM> for holding a filter <NUM> and an attachment <NUM>, which will be described later, are provided on the outer diameter side of the wall <NUM>. A plate-like cassette holder <NUM> that projects to the inner diameter side is provided at both end portions on the inner diameter side of the small chamber <NUM>.

The cassette holder <NUM> includes a first sensor <NUM> and a second sensor <NUM> for detecting the kinds of liquids that pass inside a first tube <NUM> and a second tube <NUM>, both to be described later, as well as detaching levers <NUM> and holder projections <NUM> provided on both ends in the circumferential direction. The first sensor <NUM> and the second sensor <NUM> include light emitting sections 40a, 42a (see <FIG>) and light receiving sections 40b, 42b (see <FIG>). wherein the kind of liquid passing between these sections can be determined based on the degree of transmission of light through the liquid. The light emitting sections 40a, 42a and the light receiving sections 40b, 42b are arranged in parallel with each other, and project slightly upwards at the top surface of the cassette holder <NUM>. A plurality of contacts (not shown) for connection to the first sensor <NUM> and the second sensor <NUM>, or to interface circuits thereof, are provided at a lower surface of the cassette holder <NUM>. When the contacts are placed in contact with the reception-side electrodes <NUM> (see <FIG>) provided on the central body 14a of the centrifugal drum <NUM>, signals from the first sensor <NUM> and the second sensor <NUM> can be supplied to the microcomputer.

The cover body <NUM> includes a cover, which is mounted to the unit body <NUM> from an outer lateral side thereof. The cover body <NUM> is capable of covering an outer lateral surface, an upper surface and a lower surface of the unit body <NUM>, and can securely hold the blood bag system 10a mounted on the unit body <NUM>.

Next, the blood bag system 10a and the cassette 50a according to the first embodiment will be described below. As shown in <FIG>, the blood bag system 10a comprises a multiple bag <NUM> and a cassette 50a.

As shown in <FIG>, the multiple bag <NUM> includes the BC pooling bag <NUM> in which a buffy coat (blood component) is reserved and in which the buffy coat is centrifuged into a supernatant liquid (blood component) and a sedimentary liquid by the centrifugal drum <NUM>, a filter <NUM> for removing white blood cells (predetermined cells) from the supernatant liquid transferred by pressing the BC pooling bag <NUM> by the presser <NUM>, the platelet reserving bag <NUM> for reserving the supernatant liquid obtained upon removal of white blood cells by the filter <NUM>, a first tube <NUM> for connecting the BC pooling bag <NUM> and an inlet 56a of the filter <NUM>, and a second tube <NUM> for connecting the platelet reserving bag <NUM> and an outlet 56b of the filter <NUM>. The filter <NUM> preferably is provided with a mark thereon, which is indicative of the blood flow direction.

The filter <NUM> (see <FIG>) has a roughly elliptical thin plate-like shape, with the inlet 56a provided on a first surface side at one end thereof, and the outlet 56b provided on a second surface side at the other end thereof. Each of the inlet 56a and the outlet 56b comprises a tubular body, which is elongated in the same direction as the longitudinal direction of the filter <NUM>. Inside the filter <NUM>, a planar filter medium <NUM> (see <FIG>) is provided, for partitioning the inside into a first surface side and a second surface side, respectively.

The multiple bag <NUM> further includes a third tube <NUM> having an end portion to which a container <NUM> for a platelet preserving liquid can be connected, and having the other end thereof connected to the BC pooling bag <NUM>, a branched tube <NUM> which is branched (into six branches, for example, formed through bifurcation and trifurcation) from the third tube <NUM> and to which a plurality of BC bags <NUM> can be connected, the sampling bag <NUM> for sampling the liquid contained in the platelet preserving bag <NUM>, a fourth tube <NUM> for interconnecting the platelet preserving bag <NUM> and the sampling bag <NUM>, and a sampling tube <NUM> that branches from the fourth tube <NUM>. When the blood bag system 10a is mounted in the centrifugation and separation apparatus <NUM>, the third tube <NUM> is cut after fusing thereof to prevent leakage at a location near the BC pooling bag <NUM>. The portion left upon cutting forms a third tube 70a (see <FIG>).

The multiple bag <NUM> includes a clamp <NUM> provided in the vicinity of an end portion of the third tube <NUM>, a clamp <NUM> provided on the tip side relative to the branching portion of the third tube <NUM>, a clamp <NUM> provided in the vicinity of an end portion of the fourth tube <NUM>, and a clamp <NUM> provided for the sampling tube <NUM>. Each of the tubes in the blood bag system 10a is a transparent flexible resin tube.

The clamp <NUM>, <NUM>, <NUM>, <NUM> are standard products, which have hitherto been used, and the tubes onto which they are mounted can be closed and opened by operating the clamp <NUM>, <NUM>, <NUM>, <NUM> with one's fingers. It is recommendable to provide the clamp <NUM>, <NUM>, <NUM>, <NUM> with different colors according to the position and/or the purpose of use thereof. At times of sterilization and storage of the blood bag system 10a, each of the clamp <NUM>, <NUM>, <NUM>, <NUM> is in an opened state, so that the inside of the multiple bag <NUM> is in a mutually connected and uniformly sterilized state.

Each of end portions of the third tube <NUM>, the branched tube <NUM>, and the sampling tube <NUM> is closed by a predetermined means, and is placed in a sterilized state obtained by being subjected to a predetermined sterilizing treatment (for example, irradiation with γ-rays) together with the cassette 50a.

Incidentally, although for convenience of illustration it is shown in <FIG> that the BC bag <NUM> and the container <NUM> can be connected to the multiple bag <NUM> lacking the cassette 50a, in practice the BC bag <NUM> and the container <NUM> are connected in a condition where the cassette 50a is provided as the blood bag system 10a (see <FIG>), as will be described later.

Returning to <FIG>, the blood bag system 10a includes the multiple bag <NUM> and the cassette 50a. The cassette 50a is fitted with the first tube <NUM> and the second tube <NUM>.

As shown in <FIG>, <FIG> and <FIG>, the cassette 50a includes a plate section <NUM> to be mounted to the cassette holder <NUM>, an arch section <NUM> for interconnecting both end portions on the outer side of the plate section <NUM>, and a filter holder <NUM> connected to a central portion on the outermost diameter side of the arch section <NUM>. The material of the cassette 50a, for example, is PP (polypropylene), POM (polyoxymethylene), or the like.

The arch section <NUM> is shaped along the top end of the wall <NUM>, and the space surrounded by the outer end surface of the plate section <NUM> and the arch section <NUM> has the same shape as the upper surface portion of the small chamber <NUM>, thereby forming a bag hole <NUM> in which to insert the BC pooling bag <NUM>. A portion of the whole length part of the arch section <NUM> may be provided with an angled structure so as to enhance strength.

The plate section <NUM> includes the first clamp section <NUM> and the second clamp section <NUM> provided on the inner diameter side by integral molding, a sensor hole <NUM> which is provided at a roughly central portion and in which the first sensor <NUM> and the second sensor <NUM> are inserted, a first guide passage <NUM> for guiding the first tube <NUM>, a second guide passage <NUM> for guiding the second tube <NUM>, an auxiliary fixing section <NUM> for fixing the short third tube 70a, and two pins (holding sections) <NUM> provided at an outer end portion.

The two pins <NUM> have an appropriate enlarged-tip shape, and are inserted in end holes of the BC pooling bag <NUM>, thereby fixing the end portions of the BC pooling bag <NUM>. The BC pooling bag <NUM> has an end portion fixed by the pins <NUM>, and a body portion inserted into the bag hole <NUM>. Each of the pins <NUM> may have a tip portion split in two, so as to form a narrow slit. Therefore, at the time of fixing the BC pooling bag <NUM>, the pins <NUM> can be inserted in the end holes by reducing the diameter thereof in a manner of narrowing the slit and, after insertion, the pins <NUM> can be returned to their initial state, so as to produce a slip-off preventive effect.

The auxiliary fixing section <NUM> is formed by walls making light contact with both side surfaces of the third tube 70a, and is shaped so as to bend in the direction of an outer diameter thereof, after guiding the third tube 70a in an appropriate amount in the first circumferential direction B1, from an inner diameter side end portion of the BC pooling bag <NUM>. This ensures that, on the third tube 70a, only a sufficiently short tip portion protrudes from the plate section <NUM> (see <FIG> and <FIG>), and the direction of protrusion is outwards (namely, in the centrifugal direction A1), so that the third tube 70a is not vibrated or moved during centrifugation.

The first guide passage <NUM> and the second guide passage <NUM> each has a groove shape, which is formed by walls provided on both sides substantially over the whole length thereof, and which is open on the upper side. The first guide passage <NUM> and the second guide passage <NUM> are provided with small slip-off preventive projections <NUM> at the open upper end portions thereof.

The first guide passage <NUM> extends in the direction of the inner diameter from an end portion of the BC pooling bag <NUM>, passes through the sensor hole <NUM>, is bent in the first circumferential direction B1 in the vicinity of an inner diameter side end surface, immediately thereafter passes through the first clamp section <NUM>, is bent in the direction of the outer diameter in the vicinity of an end portion in the first circumferential direction B1, and reaches an outer diameter end of the plate section <NUM>, where the first guide passage <NUM> bends inwards so as to point toward the filter holder <NUM>.

The second guide passage <NUM> extends in the direction of the inner diameter from the sensor hole <NUM>, is bent in the second circumferential direction B2 in the vicinity of an inner diameter side end surface, immediately thereafter passes through the second clamp section <NUM>, is bent in the direction of the outer diameter in the vicinity of an end portion in the second circumferential direction B2, and thereafter is bent toward a skew lateral side.

As shown in <FIG>, in the sensor hole <NUM>, the first tube <NUM> and the second tube <NUM> each have upper surfaces thereof fixed stably by two arms <NUM> having tips bent slightly downwards, and extend respectively in the radial direction. The first tube <NUM> and the second tube <NUM> are arranged in parallel in the circumferential direction, in such a manner that gaps are secured at both side surfaces in the circumferential direction of the sensor hole <NUM>, and another gap is secured between the first tube <NUM> and the second tube <NUM>. When the cassette 50a is mounted on the cassette holder <NUM>, the first sensor <NUM> and the second sensor <NUM> are inserted into the gaps in the sensor hole <NUM>, the first tube <NUM> is disposed between the light emitting section 40a and the light receiving section 40b, and the second tube <NUM> is disposed between the light emitting section 42a and the light receiving section 42b. The light receiving section 40b and the light receiving section 42b are formed integrally. The first tube <NUM> and the second tube <NUM> are held by the four arms <NUM>, so as to remain stable irrespective of the orientation of the cassette 50a. The gap in the circumferential direction between the two arms <NUM>, which are opposed to each other in the circumferential direction, is formed narrowly to such an extent that the first tube <NUM> and the second tube <NUM> can pass through the gap in a pressed-down state. As is apparent from <FIG> and <FIG>, the first clamp section <NUM> and the second clamp section <NUM> are disposed in the vicinity of the sensor hole <NUM>, and are provided on the downstream side of the first sensor <NUM> and the second sensor <NUM>.

As shown in <FIG>, the first clamp section <NUM> has a closing section (pressing section) <NUM>, which is provided as part of the first guide passage <NUM> at a portion on the first circumferential direction B1 side of an inner circumferential end of the plate section <NUM> and which closes the first tube <NUM>, a latch section <NUM> for holding the closing section <NUM> during closure thereof, and a triangular projection <NUM> provided on a surface on an opposite side from the closing section <NUM>.

The closing section <NUM> has a bulge portion (pressing portion) <NUM> for pressing the first tube <NUM> from a lateral side thereof, and an acute-angular engaged portion <NUM> provided at the tip of the bulge portion <NUM>. A base portion of the closing section <NUM> is formed sufficiently small in diameter, so that the bulge portion <NUM> can be elastically advanced and retracted substantially in the radial direction. The latch section <NUM> has an engaging portion <NUM> for engagement with the engaged portion <NUM> of the bulge section <NUM> in a state of pressing the first tube <NUM>, and an inclined surface <NUM> formed at the tip thereof. A direction perpendicular to the inclined surface <NUM> is oriented toward a skew inner side. Due to the presence of the inclined surface <NUM>, the latch section <NUM> has a tapered shape when viewed in plan. The latch section <NUM> is formed with a sufficiently small diameter at the base portion thereof, and can be elastically tilted.

The first clamp section <NUM> is thus configured simply. In addition, the first clamp section <NUM> is formed by integral molding with the cassette 50a, so that it is unnecessary to provide the clamp as an independent component part, and a reduction in the number of component parts can be achieved.

As shown in <FIG>, in the initial condition of the first clamp section <NUM>, the bulge portion <NUM> of the closing section <NUM> is separated from the first tube <NUM>, whereby the first tube <NUM> is placed in a conducting state.

As shown in <FIG>, when the first rod <NUM> of the central body 14a is extended to press the closing section <NUM> from a lateral side and to displace the closing section <NUM>, the bulge portion <NUM> presses down the first tube <NUM> in cooperation with the projection <NUM>, so as to close the first tube <NUM>. In this instance, the engaged portion <NUM> engages with the engaging portion <NUM> by slightly tilting the latch section <NUM>. Thereafter, the closed state of the first tube <NUM> by the bulge portion <NUM> is maintained, even after the first rod <NUM> returns to its original position.

As shown in <FIG>, when the second rod <NUM> is extended, the tip surface thereof slides on the inclined surface <NUM> and pushes outwardly toward a lateral side, and the latch section <NUM> is tilted, whereby the engaging portion <NUM> becomes disengaged from the engaged portion <NUM>, and the engaged state is released. Therefore, when the second rod <NUM> contracts to its original position, the first clamp section <NUM> is returned to the initial state shown in <FIG>, and the first tube <NUM> is again placed in a conducting state.

Since the second clamp section <NUM> is symmetrical with the first clamp section <NUM>, detailed description thereof is omitted. By means of the second clamp section <NUM>, the second tube <NUM> can be closed and opened. When the blood bag system 10a is mounted on the centrifugation and separation apparatus <NUM>, the first clamp section <NUM> and the second clamp section <NUM> are operated by the first clamp driving means 17a and the second clamp driving means 17b of the central body 14a (see <FIG>). When the blood bag system 10a is not mounted, the first clamp section <NUM> and the second clamp section <NUM> can be operated manually.

As shown in <FIG> and <FIG>, the filter holder <NUM> has a hinge section <NUM>, an attachment <NUM>, and a tube engaging section <NUM>.

As shown in <FIG>, the hinge section <NUM> is basically composed of a pair of ear pieces <NUM> opposed to each other in the circumferential direction, and a vertical wall (stopper) <NUM> provided on the base end side. A thin projection <NUM> projects in the direction of the outer diameter from the lower end of the vertical wall <NUM>. The vertical wall <NUM> enables the filter <NUM> to be set at a more accurate angle.

The pair of ear pieces <NUM> are provided on inner sides thereof with a pair of round shafts <NUM> that face toward each other above the projection <NUM>, a pair of small upper stoppers <NUM> provided at upper end portions on the outer diameter side, and a pair of small ride-over projections <NUM> provided at lower portions. As is apparent from <FIG>, the round shafts <NUM> are constituted by shafts that extend in the circumferential direction, whereby the filter <NUM> can be tilted with reference to the round shafts <NUM>.

As shown in <FIG>, since the round shafts <NUM> are provided at upper portions of the ear pieces <NUM>, it is possible to move the filter <NUM>, the outlet 56b and the attachment <NUM> to appropriately high positions in their expanded state. Further, when the assembly is placed on a table surface, such members exert only their own weights on the BC pooling bag <NUM>, and an excessive pressure is not exerted on the BC pooling bag <NUM>.

As shown in <FIG>, the attachment <NUM> has a support plate <NUM>, which makes contact with and thereby supports one side surface in the longitudinal direction as well as the half upper portion and the half lower portion of the filter holder <NUM>, a hinge turning section <NUM> having a semicircular arc-like sectional shape that engages with the round shafts <NUM>, and an arm <NUM> connecting an end portion of the support plate <NUM> and the hinge turning section <NUM>. The arm <NUM> includes a quadrilateral hole <NUM>, in which the projection <NUM> is snugly inserted, and left and right reinforcement plates <NUM>.

The support plate <NUM> includes a pair of filter holding projections <NUM> provided on the inside surface so as to hold both surfaces of the filter <NUM>, tube holding projections <NUM> provided on the outside surface so as to hold the first tube <NUM> at three positions, a first semicircular notch portion (first fitting portion) <NUM> provided at an upper tip portion for fitting of the inlet 56a therein, and a second semicircular notch portion (second fitting portion) <NUM> provided at a lower base end portion for fitting of the outlet 56b therein. In a bent condition, the first semicircular notch portion <NUM> is disposed on the outer diameter side relative to the second semicircular notch portion <NUM>.

When the attachment <NUM> is fitted to the hinge section <NUM>, the hinge turning section <NUM> with the arm <NUM> directed downward is fitted over the round shafts <NUM> from a lateral side, and thereafter, the attachment <NUM> is pushed down by exerting some force thereon, while permitting the arm <NUM> to ride over the upper stoppers <NUM>. Thus, the attachment <NUM> is easily mounted in position.

Incidentally, the hinge section <NUM> is not limited to a shaft-like configuration based on the round shafts <NUM>. For example, a configuration may also be adopted in which a thin section or an elastic section is bent.

A tube engaging section <NUM> is provided at a portion adjacent to the hinge section <NUM> of the arch section <NUM>, for thereby holding the second tube <NUM> in an appropriate orientation.

According to the filter holder <NUM>, the filter <NUM> can be stably held by the attachment <NUM>, and the first tube <NUM> and the second tube <NUM> can be appropriately held by the tube holding projections <NUM> and the tube engaging section <NUM>.

In addition, when the hinge turning section <NUM> is turnably supported on the round shafts <NUM>, the attachment <NUM> and the filter <NUM> can be tilted into various states, inclusive of an expanded state (see <FIG>) in which the attachment <NUM> and the filter <NUM> are parallel to and substantially in the same plane as the cassette 50a, and a bent state (see <FIG>) in which the attachment <NUM> and the filter <NUM> are bent at an angle of <NUM>° relative to the cassette 50a.

In the expanded (spread) state in which the attachment <NUM> and the filter <NUM> are substantially in the same plane as the cassette 50a, further turning thereof is prevented by the upper stoppers <NUM>. Since the upper stoppers <NUM> are sufficiently small, however, the attachment <NUM> and the filter <NUM> may be turned beyond the upper stoppers <NUM>, if necessary, by exerting an appropriate force thereon.

In the condition where the attachment <NUM> and the filter <NUM> are bent at <NUM>° relative to the cassette 50a, a side surface of the arm <NUM> makes surface contact with the vertical wall <NUM>, whereby assured angular positioning is achieved. In this instance, the projection <NUM> is inserted into the quadrilateral hole <NUM>, whereby stability of the attachment <NUM> is enhanced. In addition, when an operation is performed to bend the attachment <NUM>, both side portions of the attachment <NUM> ride over the ride-over projections <NUM>, and an appropriate click feeling is obtained. Therefore, the operator can recognize that the attachment <NUM> has been set at an appropriate angle.

The tip of the projection <NUM> may be enlarged in diametral size, so that a more assured click feeling is produced when the projection <NUM> is inserted into the quadrilateral hole <NUM>, and so that the projection <NUM> is prevented from slipping off.

According to the aforementioned filter holder <NUM>, at times of storage and transportation of the blood bag system 10a and the like, by placing the attachment <NUM> and the filter <NUM> in an expanded state substantially in the same plane as the cassette 50a, the assembly is made sufficiently thin. Accordingly, the assembly can be placed in a vinyl resin bag or the like, together with (for example, in a state of being stacked with) the BC pooling bag <NUM> and the platelet preserving bag <NUM>. Although such a packed-in-bag state is not shown in the drawings, it is apparent from <FIG> that the blood bag system 10a can be contained in a folded state within a vinyl resin bag, which is slightly larger than the platelet preserving bag <NUM> that makes up the largest of the component parts in area.

Further, when buffy coats are introduced into the BC pooling bag <NUM> from a required number of BC bags <NUM>, by placing the attachment <NUM> and the filter <NUM> in an expanded state substantially in the same plane as the cassette 50a, it is ensured that the system does not expand uselessly, and the system can be easily hung from a girdle stand.

On the other hand, it is preferable for the filter <NUM> to be preliminarily regulated in orientation when placed in use. Specifically, in order for white blood cells to be removed by the filter <NUM>, the flow direction is set such that the blood component is supplied through the inlet 56a and is guided out through the outlet 56b.

According to the filter holder <NUM>, when the blood bag system 10a is mounted in the centrifugation and separation apparatus <NUM>, the system is used in a condition where the attachment <NUM> and the filter <NUM> are bent at <NUM>° relative to the cassette 50a. In addition, as shown in <FIG>, the filter <NUM> is held such that the outlet 56b is on a proximal side relative to the hinge section <NUM>, whereas the inlet 56a is on a distal side relative to the hinge section <NUM>. Thus, the filter <NUM> is used in a condition where the flow direction is oriented against the centrifugal force. As a result, the supernatant liquid <NUM> flows against the centrifugal force into the filter <NUM>, whereby the flow velocity is suppressed appropriately, and white blood cells can be removed assuredly.

In addition, since the inlet 56a is located below and on the outer diameter side in relation to the outlet 56b, the supernatant liquid <NUM> having flowed in through the inlet 56a initially collects in a lower portion of the interior of the filter <NUM>, on the outer side of a filter medium <NUM> (see <FIG>) disposed in the filter <NUM>, and spreads in the lumen of the filter <NUM> along an outer diameter side surface while the centrifugal force acts thereon. After the space on the outer side of the filter medium <NUM> is filled, the supernatant liquid <NUM> is filtered while passing through the filter medium <NUM> and is discharged through the outlet 56b. Therefore, the supernatant liquid <NUM> is filtered while effectively utilizing the entire surface of the filter medium <NUM> inside the filter <NUM>. Accordingly, white blood cells can be removed more assuredly.

Furthermore, at the time of assembling the filter holder <NUM>, the orientation of the filter <NUM> is determined by the first semicircular notch portion <NUM>, in which the inlet 56a is fitted, and the second semicircular notch portion <NUM>, in which the outlet 56b is fitted, whereby misassembly can be prevented from occurring.

Next, a method of using the blood bag system 10a and the cassette 50a according to the first embodiment configured in the foregoing manner will be described below.

First, as shown in <FIG>, the clamp <NUM> on the third tube <NUM>, the first clamp section <NUM> and the second clamp section <NUM> are closed. A required number of BC bags <NUM> are connected to the branched tube <NUM>, and the container <NUM> for the platelet preserving liquid is connected to the third tube <NUM>. Buffy coats (or whole blood) collected from different donors are reserved in the BC bags <NUM>, respectively. Then, the buffy coats are collected from the BC bags <NUM> into the BC pooling bag <NUM>.

Next, on the third tube <NUM>, the clamp <NUM> is closed whereas the clamp <NUM> is opened, whereby the platelet preserving liquid is transferred into the BC bags <NUM>, and the platelet preserving liquid is mixed into the buffy coats remaining in the BC bags <NUM>.

Further, the clamp <NUM> is closed and the clamp <NUM> is opened, whereby the buffy coats mixed together with the platelet preserving liquid are transferred into the BC pooling bag <NUM>.

The BC pooling bag <NUM> is pressed by hand, whereby the air inside the BC pooling bag <NUM> is transferred into the BC bags <NUM>.

Then, the third tube <NUM> is cut, after being fused and sealed in an anti-leaking manner, at a position near the BC pooling bag <NUM>. The remaining portion forms a short third tube 70a, as shown in <FIG>, and the third tube 70a is fixed in the auxiliary fixing section <NUM> so that the tip thereof is oriented in the centrifugal direction. The third tube 70a may be cut shorter than that shown in <FIG>.

Subsequently, as shown in <FIG>, the attachment <NUM> and the filter <NUM> are bent at <NUM>° relative to the cassette 50a. The filter holder <NUM> acts to accurately and stably hold the attachment <NUM> and the filter <NUM> in a state of being bent at <NUM>°. Since, as mentioned above, the inlet 56a is located below and on the outer diameter side in relation to the outlet 56b when the attachment <NUM> and the filter <NUM> are bent at <NUM>° relative to the cassette 50a, the flow velocity is suppressed and the entire surface of the filter medium <NUM> inside the filter <NUM> is effectively utilized.

Furthermore, as shown in <FIG>, the blood bag system 10a is mounted in the insert unit <NUM>. Specifically, the cassette 50a is mounted in the cassette holder <NUM> and held by the holder projections <NUM>, the BC pooling bag <NUM> is inserted into the small chamber <NUM>, the filter <NUM> and the filter holder <NUM> are inserted into the filter pocket <NUM>, and the platelet preserving bag <NUM> and the sampling bag <NUM> are inserted into the large chamber <NUM>. Incidentally, since the filter <NUM> is maintained quite stably in a state of being bent at <NUM>° by the filter holder <NUM>, a configuration in which the filter pocket <NUM> is omitted, and the filter <NUM> and the filter holder <NUM> are kept in the large chamber <NUM>, may also be adopted, depending on design conditions.

In this case, as shown in <FIG>, the first tube <NUM> and the second tube <NUM> are properly arranged in the sensor hole <NUM>. Therefore, the first tube <NUM> is appropriately clamped between the light emitting section 40a and the light receiving section 40b of the first sensor <NUM>, whereas the second tube <NUM> is appropriately clamped between the light emitting section 42a and the light receiving section 42b of the second sensor <NUM>. Naturally, the first tube <NUM> is not arranged at a detection position of the second sensor <NUM>, and the second tube <NUM> is not arranged at a detection position of the first sensor <NUM>.

The arch section <NUM> is stabilized by abutment and mounting thereof on the upper end surface of the wall <NUM>, so that the attachment <NUM> and the filter <NUM> suspended from the arch section <NUM> also are made stable.

In addition, the BC pooling bag <NUM> is supported by the two pins <NUM>, whereas the first tube <NUM> connected to the BC pooling bag <NUM> is fixed along the first guide passage <NUM>. Therefore, the first tube <NUM> is arranged and oriented in the inner diameter direction A2, as viewed from the BC pooling bag <NUM>.

Next, as shown in <FIG>, the insert unit <NUM>, with the blood bag system 10a inserted therein, is inserted into the unit insertion hole <NUM> of the centrifugation and separation apparatus <NUM>. As a result, an end portion of the cassette 50a is fixed by the holding lever <NUM> (see <FIG>). In addition, the contacts of the first sensor <NUM> and the second sensor <NUM>, or interface circuits thereof, are placed in contact with the electrodes <NUM> (see <FIG>).

While six insert units <NUM>, basically, are mounted in the centrifugation and separation apparatus <NUM>, the number of insert units <NUM> may be five or less, so long as the insert units <NUM> are in balance (preferably, three or two at regular angular intervals).

When the insert unit <NUM> is inserted into the unit insertion hole <NUM>, the first clamp section <NUM> and the second clamp section <NUM> are disposed properly at corresponding positions facing the first clamp driving means 17a and the second clamp driving means 17b (see <FIG>), respectively. Since the first tube <NUM> and the second tube <NUM> are preliminarily arranged properly by the first guide passage <NUM> and the second guide passage <NUM> in relation to the first clamp section <NUM> and the second clamp section <NUM>, the first clamp section <NUM> and the second clamp section <NUM> can be properly closed and opened through the first clamp section <NUM> and the second clamp section <NUM> under actions of the microcomputer.

Thus, in a series of operations by which the blood bag system 10a and the cassette 50a are mounted, each of the tubes in the blood bag system 10a is preliminarily connected properly. Specifically, by means of the first guide passage <NUM> and the second guide passage <NUM> in the cassette 50a, the first tube <NUM> and the second tube <NUM> are disposed properly in relation to the sensor hole <NUM>, the first clamp section <NUM> and the second clamp section <NUM>. Therefore, the operator does not require special knowledge or understanding of operations and procedures for arranging the tubes, whereby the operator can easily and speedily carry out mounting of the blood bag system 10a, without possibility of mismounting. The first tube <NUM> and the second tube <NUM> are preliminarily arranged properly within the cassette 50a. In practice, therefore, the operator will be able to mount the blood bag system 10a in the centrifugation and separation apparatus without referring to any manuals or the like.

Next, the cover <NUM> of the centrifugation and separation apparatus <NUM> is closed, whereupon a centrifugation step and a separation step (a transfer step) are performed by operating the console section <NUM>.

During automatic operation of the centrifugation and separation apparatus <NUM>, first, the centrifugal drum <NUM> is rotated to perform the centrifugation step. In this case, the first clamp section <NUM> and the second clamp section <NUM> are preliminarily closed. For enhancing security of operation, however, as shown in <FIG>, the first rod <NUM> is extended initially so that the first clamp section <NUM> is placed in a flat state by the closing section <NUM>. The second clamp section <NUM> also is placed in a closed state in the same manner.

As shown in <FIG>, during the centrifugation step, a centrifugal force is imparted to the buffy coat reserved in the BC pooling bag <NUM> inside the small chamber <NUM>. As a result, the sedimentary liquid <NUM> containing heavy blood cell components and the like is moved in the direction of the outer diameter, whereas the supernatant liquid <NUM> containing light platelet components and the like is moved in the direction of the inner diameter, whereby the liquids become separated from each other. The supernatant liquid <NUM> contains white blood cells. The sedimentary liquid <NUM> is deep red in color and low in transparency, while the supernatant liquid <NUM> is constituted by a somewhat yellow-white transparent matter.

The centrifugation and separation apparatus <NUM> shifts from the centrifugation step to the separation step. During the separation step, while the centrifugal drum <NUM> continues to rotate, the second rod <NUM> is extended once as shown in <FIG> so as to tilt the latch section <NUM> and release the engaged state, thereby returning the centrifugation and separation apparatus <NUM> to the initial condition shown in <FIG> and placing the first tube <NUM> in an open state. The second tube <NUM> also placed in an open state in the same manner.

Next, as shown in <FIG>, the presser <NUM> is displaced in the centrifugal direction A1 so as to press the BC pooling bag <NUM>. The internal volume of the BC pooling bag <NUM> is reduced while being clamped between the presser <NUM> and the wall <NUM>, whereby the liquid contained therein is discharged through the first tube <NUM>. In this instance, in the interior of the BC pooling bag <NUM>, the sedimentary liquid <NUM> is collected in the direction of the outer diameter, while the supernatant liquid <NUM> is collected in the direction of the inner diameter. Meanwhile, the first tube <NUM> is oriented in the direction of the inner diameter, so that only the supernatant liquid <NUM> is ejected into the first tube <NUM>.

The supernatant liquid <NUM> that is ejected into the first tube <NUM> flows past the location of the first clamp section <NUM>, which is in an open state, whereupon white blood cells are removed therefrom by the filter <NUM>. In this instance, since the filter <NUM> is set so that the inlet 56a is located below and on the outer diameter side relative to the outlet 56b, the supernatant liquid <NUM> flows in a direction resistant to gravity and centrifugal force. Therefore, the flow velocity of the supernatant liquid <NUM> is suppressed, and removal of white blood cells can be achieved assuredly through effective utilization of the entire surface of the filter medium <NUM>. The supernatant liquid <NUM> having passed through the filter <NUM> flows past the location of the second clamp section <NUM>, which is in an open state, and is supplied into and reserved within the platelet preserving bag <NUM>.

It is desirable that the supernatant liquid <NUM> in the BC pooling bag <NUM> be transferred into the platelet preserving bag <NUM> as completely as possible. However, it is undesirable for the sedimentary liquid <NUM> to be transferred into the platelet preserving bag <NUM>. In view of this, the liquids that pass through the first tube <NUM> and the second tube <NUM> are monitored by the first sensor <NUM> and the second sensor <NUM>, and a control is carried out in order to prevent the sedimentary liquid <NUM> from being transferred into the platelet preserving bag <NUM>.

Specifically, the microcomputer monitors signals supplied thereto from the first sensor <NUM> and the second sensor <NUM>, determines transparency values of the liquids that pass through the first tube <NUM> and the second tube <NUM> based on the magnitudes of the signals, and distinguishes the supernatant liquid <NUM> and the sedimentary liquid <NUM> from each other by their respective transparencies.

When the BC pooling bag <NUM> is pressed by the presser <NUM> during the separation step, the supernatant liquid <NUM> is guided out into the first tube <NUM> at a beginning period, so it can be confirmed by the first sensor <NUM> and the second sensor <NUM> that the supernatant liquid <NUM> is flowing therein due to the transparency of the liquid.

While pressing of the BC pooling bag <NUM> by the presser <NUM> is continued, the supernatant liquid <NUM> in the BC pooling bag <NUM> flows out completely, and thereafter, the sedimentary liquid <NUM> is guided out. As a result, at first, the first sensor <NUM> detects that the liquid flowing through the first tube <NUM> is changed into the sedimentary liquid <NUM>. At this point in time, the separation step may be considered finished. In order to collect the platelets into the platelet preserving bag <NUM> as much as possible, however, it is desirable that portions of the supernatant liquid <NUM>, which remain in the first tube <NUM> and the second tube <NUM>, also are fed out into the platelet preserving bag <NUM>. From this point of view, after the sedimentary liquid <NUM> has been detected by the first sensor <NUM>, pressing by the presser <NUM> may be further continued for a predetermined period of time.

Next, upon elapse of a predetermined time period, when it has been detected by the second sensor <NUM> that the liquid flowing through the second tube <NUM> has changed into the sedimentary liquid <NUM>, the first rods <NUM> are extended (see <FIG>) in order to close the first clamp section <NUM> and the second clamp section <NUM>, thereby placing the first tube <NUM> and the second tube <NUM> in a closed state. Further, the centrifugal drum <NUM> is stopped, whereupon the separation step is finished.

Upon elapse of a predetermined period of time from detection of the sedimentary liquid <NUM> by the first sensor <NUM>, the sedimentary liquid <NUM> reaches the filter <NUM>, and portions of the supernatant liquid <NUM> which remain in the first tube <NUM> and the second tube <NUM> are fed out into the platelet preserving bag <NUM> accordingly. Incidentally, before the predetermined time period has lapsed, basically, the sedimentary liquid <NUM> will not reach the position of the second sensor <NUM> (namely, the position of the sensor hole <NUM>). In order to prevent the sedimentary liquid <NUM> from mixing into the platelet preserving bag <NUM>, however, monitoring thereof by the second sensor <NUM> is performed.

Immediately upon detection by the second sensor <NUM> of transfer of the sedimentary liquid <NUM> into the second tube <NUM>, the first clamp section <NUM> and the second clamp section <NUM> are simultaneously placed in a closed state, so as to prevent the sedimentary liquid <NUM> from flowing further downstream. There is a slight time lag until the first clamp section <NUM> and the second clamp section <NUM> become fully closed after detection of the sedimentary liquid <NUM> by the second sensor <NUM>. In the course of the second tube <NUM>, however, the second clamp section <NUM> is located on a downstream side relative to the position of the sensor hole <NUM>, where the second sensor <NUM> is provided. Therefore, the sedimentary liquid <NUM> does not flow to the downstream side of the second clamp section <NUM>. Even if the sedimentary liquid <NUM> flows past the position of the second clamp section <NUM>, the sedimentary liquid <NUM> will not reach the platelet preserving bag <NUM>, because a certain distance is provided between the position of the second clamp section <NUM> and the platelet preserving bag <NUM>.

When the separation step is finished, and the centrifugal drum <NUM> is stopped completely in this manner, the cover <NUM> is opened. The insert units <NUM> are taken out by operating the holding levers <NUM>, and the blood bag systems 10a are taken out by detaching the cover bodies <NUM>. In this case, the cassette 50a can easily be detached from the cassette holder <NUM> simply by operating the detaching levers <NUM> (see <FIG>).

Further, the first tube <NUM> in the blood bag system 10a is cut after being fused at a position near the BC pooling bag <NUM>, whereby the BC pooling bag <NUM> serves as a blood product containing blood cell components. On the other hand, when the second tube <NUM> is cut after being fused at a position near the platelet preserving bag <NUM>, the platelet preserving bag <NUM> serves as a blood product containing platelets. The blood product of the platelet preserving bag <NUM> permits a portion thereof to be transferred into the sampling bag <NUM>, and to be served to a predetermined test or the like.

According to the blood bag system 10a and the cassette 50a of the first embodiment, as mentioned above, the cassette 50a has the first tube <NUM> and the second tube <NUM> preliminarily arranged properly therein, so that it is sufficient simply to mount the cassette 50a into the central body 14a of the centrifugation and separation apparatus <NUM>. Therefore, the need for intricate laying and arrangement of the first tube <NUM> and the second tube <NUM>, as well as the need for arranging the first clamp section <NUM> and the second clamp section <NUM>, are eliminated, and mounting can be carried out easily and assuredly. In addition, the cassette 50a includes the first clamp section <NUM> and the second clamp section <NUM>, which are disposed properly in relation to the first clamp driving means 17a and the second clamp driving means 17b within the centrifugation and separation apparatus <NUM>.

In addition, since the first clamp section <NUM> and the second clamp section <NUM> are formed by integral molding with the cassette 50a, the first clamp section <NUM> and the second clamp section <NUM> can be configured easily, and such integral molding enables a reduction in the number of component parts. Naturally, the operator does not need to mount the first clamp section <NUM> and the second clamp section <NUM> to the cassette 50a, so that the required procedure is simple and there is no fear of misarrangement.

The cassette 50a is fixed to the centrifugation and separation apparatus <NUM> such that the first tube <NUM> and the second tube <NUM> are partially set horizontally and oriented in the radial direction, and so that the blood components inside the tubes flow in the direction of the inner diameter. In these parts, the blood components flow against centrifugal force, so that the flow velocities thereof can be prevented from increasing excessively.

Further, the first tube <NUM> and the second tube <NUM> cross the sensor hole <NUM> on the upper side and in a radial direction, while being located to enable detection thereof by the first sensor <NUM> and the second sensor <NUM>. Thus, the liquids inside the first tube <NUM> and the second tube <NUM> can be detected reliably.

The two pins <NUM>, which serve as a holding section for the cassette 50a, hold an end portion where the first tube <NUM> of the first bag is provided. As a result, the first tube <NUM> is oriented in the direction of the inner diameter, and the supernatant liquid <NUM>, which is collected in the direction of the inner diameter by the centrifugation step, can be transferred from the first tube <NUM> during the separation step.

The cassettes 50a each have the first clamp section <NUM> and the second clamp section <NUM> arranged in parallel with each other in the circumferential direction, on a side pointing toward the center of rotation of the centrifugal drum <NUM> of the centrifugation and separation apparatus <NUM>, whereby the first clamp driving means 17a and the second clamp driving means 17b can be arranged in a concentrated manner within the central body 14a at the rotating section. In addition, with the first clamp section <NUM> and the second clamp section <NUM> arranged side by side in the circumferential direction, the surface on the rotational center side of the cassette 50a is utilized effectively, and good balance is secured. Further, with the first clamp section <NUM> and the second clamp section <NUM> arranged in parallel with each other in the circumferential direction, the cassette 50a forms a single layer in which overlapping of the first tube <NUM> with the second tube <NUM> does not occur at any location, and further, the cassette 50a has a simple structure such that arrangement of the first tube <NUM> and the second tube <NUM> during the manufacturing stage is easy to carry out.

Since the cassette 50a includes the attachment <NUM> by which the filter <NUM> is held so as to be changed in orientation, orientations of the filter <NUM> during storage and during use thereof can be changed appropriately.

The blood bag system 10a and the cassette 50a are inexpensive configurations, which are suitable for disposable use.

Assembly, packaging and a sterilizing treatment of the blood bag system 10a are performed under a predetermined quality control by the manufacturer. The blood bag system 10a is assembled by a predetermined automatic machine, or is assembled manually by use of predetermined assembly jigs. Further, tests are preliminarily conducted by predetermined automatic testers, whereby an assured arrangement can be achieved.

Next, a blood bag system 10b and a cassette 50b according to a second embodiment will be described below. Components of the blood bag system 10b (and each of 10c and 10d) and the cassette 50b (and each of 50c and 50d), which are the same as those of the above-described blood bag system 10a and cassette 50a, are denoted by the same reference characters used above, and detailed descriptions of such features are omitted.

The blood bag system 10b includes the cassette 50b and a multiple bag <NUM>. The multiple bag <NUM> is basically the same as that used in the blood bag system 10a, except that a first tube <NUM> and a second tube <NUM> are provided together with a first clamp <NUM> and a second clamp <NUM>.

As shown in <FIG> and <FIG>, in place of the above-described first clamp section <NUM> and second clamp section <NUM> (see <FIG>), the blood bag system 10b has the first clamp <NUM> and the second clamp <NUM>, as well as a first clamp operating section <NUM> and a second clamp operating section <NUM>, for operating and placing the first clamp <NUM> and the second clamp <NUM> in closed and open states.

The first clamp <NUM> and the second clamp <NUM> make up means for closing and opening intermediate portions of the first tube <NUM> and the second tube <NUM>, similar to the above-described first clamp section <NUM> and second clamp section <NUM>.

As shown in <FIG>, the first clamp <NUM> is a resin body provided at one end thereof with a latch section 200a, which is short and bent back in a J-shape, and provided at the other end thereof with a closing section (pressing section) 200b, which is somewhat longer and bent back in a U-shape. The first clamp <NUM> further is provided at an inside surface thereof with a projection 200c, and at both ends thereof with holes in which to insert the first tube <NUM>. The projection 200c is located at a position slightly deviated from the center, and has a hole 200f therein. In an initial state, the closing section 200b is opened to an appropriate degree.

The latch section 200a, the closing section 200b and the projection 220c correspond respectively to the latch section <NUM>, the closing section <NUM> and the projection <NUM> described above (see <FIG>). More specifically, when the closing section 200b is pushed in toward the inner side, the first tube <NUM> can be closed by a bulge portion 200d on the inside of the closing section 200b and the projection 200c, while the closing section 200b is held by the latch section 200a.

When an inclined surface 200e at the tip of the latch section 200a is pushed toward a lateral side (or if the inclined surface 200e is pushed by a rod or the like from a lateral side) and the latch section 200a is thereby tilted toward the lateral side, the closing section 200b is released from an engaged state and returns to its original position, thereby opening the first tube <NUM>.

The second clamp <NUM> has the same structure as the first clamp <NUM>. As for the first clamp <NUM> and the second clamp <NUM>, the same structures as in the above-mentioned clamp <NUM>, <NUM>, <NUM>, <NUM> can be used.

The first clamp operating section <NUM> in the cassette 50b includes a first pressing section <NUM> for pushing in the closing section 200b by operation of a first rod <NUM>, and a second pressing section <NUM> that slides on an inclined surface 200e by operation of a second rod <NUM>, so as to tilt the latch section 200a toward a lateral side.

The first pressing section <NUM> and the second pressing section <NUM> are thinned in the vicinity of base end portions thereof so as to have elasticity, and the first pressing section <NUM> and the second pressing section <NUM> can be elastically displaced substantially in the radial direction under operations of the first rod <NUM> and the second rod <NUM>. End faces, on an inner diametrical side of the first pressing section <NUM> and the second pressing section <NUM>, are formed as outside flat surfaces 208a and 210a substantially along the circumferential direction, so that such end faces are stably pressed by the first rod <NUM> and the second rod <NUM>.

The first pressing section <NUM> is provided with an inside flat surface 208b substantially along the circumferential direction, so as to be capable of easily pressing an inner diameter side portion of a tip portion of the closing section 200b. The second pressing section <NUM> is provided with an inclined surface 210b, which is suitable for sliding along the inclined surface 200e of the latch section 200a.

The first clamp operating section <NUM> is provided with a clamp space <NUM> in which the first clamp <NUM> is held, while leaving a small gap. The clamp space <NUM> is shaped such that the first clamp <NUM> cannot be mounted therein in an erroneously deviated position, or in a reverse orientation. Specifically, the clamp space <NUM> is provided with a projection (columnar section) <NUM> that is inserted into the hole 200f, whereby positioning of the first clamp <NUM> is achieved. Since the projection 200c and the hole 200f are each located at a position slightly deviated from the center, there is no possibility of the first clamp <NUM> being mounted in a reverse orientation. Within the clamp space <NUM>, a gap is secured, which permits the latch section 200a to be tilted toward a lateral side.

The second clamp operating section <NUM> is symmetrical in shape with the first clamp operating section <NUM>. The first clamp operating section <NUM> and the second clamp operating section <NUM> can be operated respectively by the first clamp driving means 17a and the second clamp driving means 17b (see <FIG>), and can be operated manually when the blood bag system 10b is not mounted within the centrifugation and separation apparatus <NUM>.

A first guide passage <NUM> and a second guide passage <NUM> in the cassette 50b of the blood bag system 10b are shorter than those in the above-described blood bag system 10a. The first guide passage <NUM> and the second guide passage <NUM> are formed so as to extend through upper portions of a sensor hole <NUM>, to thereby guide the first tube <NUM> in a first circumferential direction B1, and the second tube <NUM> in a second circumferential direction B2.

In the blood bag system 10b and the cassette 50b configured as described above, the first tube <NUM> and the second tube <NUM> are preliminarily arranged properly, similar to the above-described blood bag system 10a and cassette 50a. Therefore, it is sufficient for the cassette 50b to be mounted within the central body 14a of the centrifugation and separation apparatus <NUM>, and the need for intricate laying and arrangement of the first tube <NUM> and the second tube <NUM> is eliminated, so that mounting thereof can be carried out easily and assuredly. In addition, the cassette 50b includes the first clamp <NUM>, the second clamp <NUM>, the first clamp operating section <NUM>, and the second clamp operating section <NUM>, with such components being arranged properly in relation to the first clamp driving means 17a and the second clamp driving means 17b (see <FIG>) of the centrifugation and separation apparatus <NUM>.

In the blood bag system 10b and the cassette 50b, conventionally used general-purpose clamp can be applied to the first clamp <NUM> and the second clamp <NUM> arranged, so that the operator can easily comprehend the clamping means during manual operation thereof. Further, in the case where the multiple bag <NUM> must be detached from the cassette 50b for some reason, the first tube <NUM> and the second tube <NUM> can be kept closed by the first clamp <NUM> and the second clamp <NUM>.

As shown in <FIG>, a blood bag system 10c and a cassette 50c according to a third embodiment have respective configurations, which are obtained by omitting the arch section <NUM> and the filter holder <NUM> from the above-described blood bag system 10a and cassette 50a.

As shown in <FIG>, a blood bag system 10d and a cassette 50d according to a fourth embodiment have respective configurations, which are obtained by omitting the arch section <NUM> and the filter holder <NUM> from the above-described blood bag system 10b and cassette 50b.

Omission of the filter holder <NUM> permits the cassettes 50c, 50d to be simpler in configuration. In this case, the filter <NUM> can be maintained in a proper attitude by the filter pocket <NUM>.

The blood bag systems 10c, 10d and the cassettes 50c, 50d have the same operational effects as those of the above-described blood bag system 10a and cassette 50a.

The blood bag systems 10a to 10d and the cassettes 50a to 50d are applicable not only to a centrifugation and separation apparatus <NUM>, but also to a blood component collection apparatus, a whole blood collection apparatus, an automatic blood separation apparatus, etc. The liquid reserved in the BC pooling bag <NUM> is not limited to a buffy coat, and depending on the use thereof, whole blood (contained liquid) may be reserved therein.

Claim 1:
A cassette (50b, 50d) comprising a multiple bag mounted thereon, the multiple bag comprising:
a first bag (<NUM>) for reserving whole blood or a blood component;
a filter (<NUM>) having a filter medium (<NUM>) for removing predetermined cells from a blood component obtained by centrifugation of the liquid contained in the first bag (<NUM>);
a second bag (<NUM>) for reserving a blood component obtained upon removal of the predetermined cells by the filter (<NUM>);
a first tube (<NUM>) for connecting the first bag (<NUM>) and an inlet of the filter (<NUM>);
a second tube (<NUM>) for connecting the second bag (<NUM>) and an outlet of the filter (<NUM>);
a first clamp (<NUM>) for closing and opening the first tube (<NUM>); and
a second clamp (<NUM>) for closing and opening the second tube (<NUM>),
wherein the cassette (50b, 50d) holds a part of the first tube (<NUM>), a part of the second tube (<NUM>), the first clamp (<NUM>) and the second clamp (<NUM>), and
the cassette (50b, 50d) includes:
a first clamp operating section (<NUM>) for operating the first clamp (<NUM>), and
a second clamp operating section (<NUM>) for operating the second clamp (<NUM>),
characterized in that
the cassette (50b, 50d) includes a plate section (<NUM>) that can be fitted to a unit body (<NUM>) of an insert unit (<NUM>), the cassette (50b, 50d) is mounted in the centrifugation and separation apparatus (<NUM>) through the insert unit (<NUM>), and
the cassette (50b, 50d) includes two pins (<NUM>) inserted into holes in the first bag (<NUM>) and fixing an end of the first bag (<NUM>) at an end portion on an outer side of the plate section (<NUM>), the two pins (<NUM>) having an appropriate enlarged tip shape and being inserted in end holes of the first bag (<NUM>), thereby fixing an end portion of the first bag (<NUM>),
the cassette (50b) further comprising
an arch section (<NUM>) for interconnecting both end portions on the outer side of the plate section (<NUM>), forming a bag hole (<NUM>) together with the plate section (<NUM>), the first bag (<NUM>) being inserted in the bag hole (<NUM>); and
a filter holder (<NUM>) connected to a central portion on an outermost diameter side of the arch section (<NUM>) and holding the filter (<NUM>).