Patent Description:
In blood transfusion, blood component transfusion is performed in which blood (whole blood) obtained by donated blood or the like are separated into blood components to provide only the components required by a patient. In this type of blood component transfusion, a blood bag system including a plurality of bags which are capable of accommodating blood or blood components is used (see document <CIT>).

Document <CIT> pertains to a Parenteral Fluid Delivery Bag with integral line set. According to a first embodiment described, a spiral wound line set is co-formed with a bag. To use the line set, it is pulled from the bag, thereby destroying a tear seal, which serves for holding the line set in a line set aperture. According to a second embodiment described, a line set is wrapped about a first fluid containing bag in a helical manner. The line has a frangible plug, the breaking of which is performed to supply the fluid in the bag to a patient. From the frangible plug, the line set is wrapped around a second chamber. Another frangible plug is provided. Breaking of the second plug leads to that the fluid supplied to the patient is then drained from the patient to the second bag.

Document <CIT> discloses a Bag for containing Fluid. Here, bags of various shapes are disclosed. The bags and equipment are formed by welding of two sheets in the intended shape of the bag. One example is a bag having a meandering tube attached.

The blood bag system includes a blood collection bag in which collected blood is accommodated, a leukocyte removal filter for removing white blood cells, a plurality of blood component bags in which various blood components are accommodated, a medicinal solution bag in which a storage solution to be added to the blood components is accommodated, and a plurality of tubes that connect these members. The blood bag system is used in a state in which the aforementioned various bags are connected by tubes.

The blood bag system is manufactured by preparing components such as the plurality of bags and a filter or the like according to specifications, and fusion bonding such components to the tubes and assembling them in a predetermined arrangement.

The specifications of blood bag systems differ from country to country, and since a large number of such specifications exist, standardization of manufacturing methods therefor has not been done, and in large part, it has been necessary for a large number of fusion bonding operations to be performed manually. Thus, in order to improve production efficiency, a method may be considered in which a blood collection bag, a blood component bag, a medicinal solution bag, a filter, and flow paths that connect these elements, which collectively form the blood bag system, are formed integrally from a pair of overlapping sheet bodies.

Incidentally, when the whole blood in the blood collection bag is transferred via the filter into the blood component bag, in order to ensure a difference in elevation between the blood collection bag and the blood component bag, there may be cases in which a flow path of a sufficient length is required. Further, an elongate flow path may be required depending on other requisite specifications. In order to form such an elongate flow path, a problem arises in that large sheet bodies are required, and the device configuration and molds required for processing of the flow paths must be made large in scale.

Thus, the invention has the object of providing a blood bag system and a manufacturing method therefor, which enable a sufficiently long flow path to be formed in an integrated manner with blood collection bags, without causing an increase in the size of the sheet bodies.

The object of the invention is achieved by a blood bag device according to claim <NUM> and by a manufacturing method according to claim <NUM>, respectively.

One aspect of the disclosure to be described below is characterized by a blood bag system equipped with a plurality of bags in which blood is accommodated, and flow paths connecting the plurality of bags, the blood bag system including a main body portion integrally formed by a first sheet body, and a second sheet body that is superimposed on the first sheet body, wherein the main body portion includes a first bag in which the blood is accommodated, a second bag in which a blood component contained in the blood is accommodated, a first flow path connecting the first bag and the second bag, and a meandering section in which portions of the first flow path are repeatedly folded back on themselves, and adjacent portions of the first flow path are fusion bonded to each other, wherein the fusion bonded portions of the first flow path of the meandering section are connected via thin-walled cuttable portions configured to be separatable.

Another aspect is characterized by a method of manufacturing a blood bag system equipped with a first bag in which blood is accommodated, a second bag in which a blood component separated from the blood is accommodated, and a first flow path connecting the first bag and the second bag, wherein the first bag, the second bag, and the first flow path are integrally formed by a first sheet body, and a second sheet body that is superimposed on the first sheet body, and the first flow path includes a meandering section that is repeatedly folded back on itself, the method of manufacturing the blood bag system including a step of preparing a first sheet body in which a first bag formation planned portion, a second bag formation planned portion, and a preprocessing unit formation planned portion are integrally connected, and a second sheet body in which a first bag formation planned portion, a second bag formation planned portion, and a preprocessing unit formation planned portion are integrally connected, a superimposing step of superimposing the second sheet body on the first sheet body, and a fusion bonding step of fusion bonding the first sheet body and the second sheet body at peripheral edge portions of the first bag formation planned portions, the second bag formation planned portions, and the preprocessing unit formation planned portions while blowing air between the first sheet body and the second sheet body, to thereby form the first bag, the second bag, and the first flow path respectively in the first bag formation planned portions, the second bag formation planned portions, and the preprocessing unit formation planned portions, wherein, in the fusion bonding step, the meandering section of the first flow path that is repeatedly folded back on itself is formed in the preprocessing unit formation planned portions.

According to the blood bag system and the method of manufacturing the same having the above-described aspects, elongate flow paths can be formed compactly by providing the meandering sections.

Hereinafter, preferred embodiments of a blood bag system and a manufacturing method therefor will be presented and described in detail below with reference to the accompanying drawings.

As shown in <FIG>, a blood bag system <NUM> according to the present embodiment serves as a system for centrifugally separating blood containing a plurality of components into a plurality of components having different specific gravities (for example, two components of a light specific gravity component and a heavy specific gravity component), and accommodating and storing the respective components in different bags. The blood bag system <NUM> according to the present embodiment is configured so as to centrifugally separate the remaining blood components, in which white blood cells and blood platelets have been removed from whole blood, into two components of blood plasma and concentrated red blood cells, and to accommodate and store the plasma and the concentrated red blood cells into different bags.

The blood bag system <NUM> includes a blood collection unit <NUM> that collects blood from a donor, a blood collection bag <NUM> (first bag) in which collected whole blood is accommodated, a preprocessing unit <NUM> that removes predetermined blood components from the whole blood, and a separation processing unit <NUM> which centrifugally separates the remaining blood components obtained by removing the predetermined components, into a plurality of blood components, together with accommodating the respective components in different bags (second bags). The above parts that constitute the blood bag system <NUM> are formed together integrally in a main body portion including a first sheet body <NUM>, and a second sheet body <NUM> that is superimposed on the first sheet body <NUM>.

The blood collection unit <NUM> includes blood collection tubes <NUM>, <NUM>, and <NUM>, a branching tube <NUM>, a breakable member <NUM>, a blood collection needle <NUM>, a branch connector <NUM>, and an initial flow blood bag <NUM>.

The branch connector <NUM> is equipped with a first port 45a, a second port 45b, and a third port 45c. The blood collection tube <NUM> is connected to the first port 45a, the branching tube <NUM> is connected to the second port 45b, and the blood collection tube <NUM> is connected to the third port 45c. One end of the blood collection tube <NUM> is connected to the first port 45a of the branch connector <NUM>, and the blood collection needle <NUM> is connected to the other end. The blood collection needle <NUM> has a needle tip that is punctured into the skin of the donor when blood collection from the donor is carried out, and is a part into which blood from the donor flows.

The second port 45b of the branch connector <NUM> is connected to one end of the branching tube <NUM>, and the initial flow blood bag <NUM> is connected to the other end thereof. The initial flow of blood when blood is collected flows into the branching tube <NUM> through the second port 45b of the branch connector <NUM>, and is accommodated in the initial flow blood bag <NUM>. The initial flow blood bag <NUM> accommodates a predetermined amount of the initial flow of blood.

One end of the blood collection tube <NUM> is connected to the third port 45c of the branch connector <NUM>, and the other end is connected to one end of the breakable member <NUM>. The breakable member <NUM> is configured in a manner so that the flow path is closed in an initial state; however, the flow path is opened by performing a breaking operation. The blood collection bag <NUM> is connected via the blood collection tube <NUM> to the other end of the breakable member <NUM>. The breakable member <NUM> is subjected to a breaking operation after the initial flow of blood is collected in the initial flow blood bag <NUM>, and thereby enables communication between the blood collection tube <NUM> and the blood collection bag <NUM>. The whole blood collected from the donor flows into the blood collection bag <NUM> through the opened breakable member <NUM>. The blood collection tube <NUM> is made from a thermoplastic resin or the like, and is configured to be fusion bonded and sealed by a tube sealer or the like and be cut, after the completion of blood collection.

The blood collection bag <NUM> (first bag) is formed in a bag shape by superimposing the first sheet body <NUM> and the second sheet body <NUM>, which are made of resin sheets, and fusion bonding (heat fusion bonding or high (radio) frequency fusion bonding) peripheral edge portions thereof. The first sheet body <NUM> and the second sheet body <NUM> are made of a material possessing flexibility and manufactured from a soft resin such as polyvinyl chloride or polyolefin. Further, it is preferable that the first sheet body <NUM> and the second sheet body <NUM> use transparent or translucent resin sheets, in order to facilitate optical discrimination between the blood plasma and the concentrated red blood cells when the blood components are transferred through a later-described transfer line <NUM>. The blood collection bag <NUM> preferably contains an anticoagulant <NUM> in order to prevent coagulation of the blood (whole blood). The anticoagulant <NUM> is normally a liquid, examples of which include an ACD-A solution, a CPD solution, a CPDA-<NUM> solution, and a heparin sodium solution. The amount of the anticoagulant <NUM> is an appropriate amount in accordance with the expected amount of blood to be collected.

One end of the blood collection tube <NUM> is connected to the blood collection bag <NUM>. Further, a plurality of connection ports <NUM> and a breakable member 32A are provided in the blood collection bag <NUM>. The blood collection tube <NUM>, the connection ports <NUM>, and the breakable member 32A penetrate through a sealed portion 14a on one end side of the blood collection bag <NUM> in a direction of joined surfaces of the first sheet body <NUM> and the second sheet body <NUM>, and communicate with the interior of the blood collection bag <NUM>.

The connection ports <NUM> are covered and sealed by covers, and are configured in a manner so that, by removing the covers, the ports are exposed to enable connection with tubes or the like. The breakable member 32A has one end connected to the interior 14b of the blood collection bag <NUM>, and another end connected to an inlet-side flow path <NUM> (first flow path) to be described later. The breakable members 32A to 32C are configured in a manner so that the flow paths are closed in an initial state; however, the flow paths are opened by performing a breaking operation. The breakable member 32A is configured in the same manner as the breakable member <NUM>, so that when a breaking operation is performed, the interior 14b of the blood collection bag <NUM> communicates with the inlet-side flow path <NUM>.

The preprocessing unit <NUM> includes a filter <NUM> for removing predetermined components (cells), an inlet-side flow path <NUM>, and an outlet-side flow path <NUM>. The inlet-side flow path <NUM> and the outlet-side flow path <NUM> constitute a first flow path connecting the blood collection bag <NUM> and a parent bag <NUM>. The inlet-side flow path <NUM> is a flow path for transferring blood collected from the donor from the blood collection bag <NUM> to the filter <NUM>. One end of the inlet-side flow path <NUM> is connected to the breakable member 32A, and another end is in communication with an inlet port 36a of the filter <NUM>. The inlet-side flow path <NUM> comprises a sealed portion 20a in which the first sheet body <NUM> and the second sheet body <NUM> are overlapped, and both side parts, which are peripheral edge portions thereof, are fusion bonded. An interior 20b thereof through which the blood flows is formed inside the portion that is sealed by the sealed portion 20a. According to the present embodiment, in the flow path <NUM>, a meandering section 20A is formed so as to be folded back on itself a plurality of times in a widthwise direction of the blood collection bag <NUM>. The elongate flow path <NUM> is formed in a compactly folded state by the meandering section 20A. In the meandering section 20A, as indicated by the one-dot dashed lines, cuttable portions <NUM> are formed between adjacent portions of the flow path <NUM>. The cuttable portions <NUM> are portions where the sealed portion 20a of the first sheet body <NUM> and the second sheet body <NUM> are formed to be thin-walled in the shape of grooves. The cuttable portions <NUM> are configured to be capable of being easily cut by pulling on the flow path <NUM>.

The outlet-side flow path <NUM> is a flow path for transferring the blood that has passed through the filter <NUM>, to the parent bag <NUM>. One end of the outlet-side flow path <NUM> is connected to an outlet port 36b of the filter <NUM>, and another end is connected to the parent bag <NUM>. In the same manner as the inlet-side flow path <NUM>, the outlet-side flow path <NUM> comprises a sealed portion 22a in which the first sheet body <NUM> and the second sheet body <NUM> are overlapped, and both side parts, which are peripheral edge portions thereof, are fusion bonded. An interior 22b thereof through which the blood flows is formed inside the portion that is sealed by the sealed portion 22a. In the flow path <NUM>, a meandering section 22A is formed so as to be folded back on itself a plurality of times in a widthwise direction of the blood collection bag <NUM> and the parent bag <NUM>. The elongate flow path <NUM> is formed in a compactly folded state by the meandering section 22A. In the meandering section 22A, as indicated by the one-dot dashed lines, the cuttable portions <NUM> are formed between adjacent portions of the flow path <NUM>, and the cuttable portions <NUM> are configured so as to be capable of being easily separated.

The filter <NUM> removes predetermined cells when the blood is transferred from the blood collection bag <NUM> to the parent bag <NUM>. According to the present embodiment, the filter <NUM> is a leukocyte removing filter. In such a leukocyte removing filter, a filter medium made of a liquid-permeable porous body or a non-woven fabric can be used. In the present embodiment, the filter <NUM> may be configured in a manner so as to enable capturing of blood platelets. An inlet port 36a and an outlet port 36b are provided in the filter <NUM>. The inlet port 36a and the outlet port 36b are made from tubular shaped resin members, and constitute an inlet and an outlet for the blood to and from the filter <NUM>.

The inlet-side flow path <NUM>, the outlet-side flow path <NUM>, and the filter <NUM> are formed by the first sheet body <NUM> and the second sheet body <NUM>, and are integrally connected to the blood collection bag <NUM> and the parent bag <NUM>. Both sides of the inlet-side flow path <NUM> and the outlet-side flow path <NUM> are sealed by the sealed portions 20a and 22a of the first sheet body <NUM> and the second sheet body <NUM>. Further, the filter <NUM> is formed in a filter accommodating unit <NUM> of the first sheet body <NUM> and the second sheet body <NUM>. Peripheral edge portions of the filter accommodating unit <NUM> are sealed in a bag shape by a sealed portion 34a between the first sheet body <NUM> and the second sheet body <NUM>. The sealed portions 20a and 22a of the inlet-side flow path <NUM> and the outlet-side flow path <NUM>, the sealed portion 34a of the filter accommodating unit <NUM>, and the sealed portion 14a of the blood collection bag <NUM> are connected in a non-separable manner.

The separation processing unit <NUM> includes the parent bag <NUM> in which residual blood from which predetermined cells have been removed by the filter <NUM> is accommodated, a child bag <NUM> in which a supernatant component obtained by centrifugally separating the blood inside the parent bag <NUM> is accommodated, a medicinal solution bag <NUM> in which a red blood cell storage solution <NUM> (medicinal solution) is accommodated, and the transfer line <NUM> connected to the parent bag <NUM>, the child bag <NUM>, and the medicinal solution bag <NUM>. According to the present embodiment, concerning the second bags in which the blood components are accommodated, two of such bags, namely, the parent bag <NUM> and the child bag <NUM>, are provided. Further, the medicinal solution bag <NUM> constitutes a third bag in which the medicinal solution is accommodated. Furthermore, the transfer line <NUM> makes up a second flow path.

The parent bag <NUM>, the child bag <NUM>, and the medicinal solution bag <NUM>, in the same manner as the blood collection bag <NUM>, are configured in bag shapes by superimposing the first sheet body <NUM> and the second sheet body <NUM>, and fusion bonding sealed portions 18a, 24a, and 26a at peripheral edge portions thereof. Moreover, on the first sheet body <NUM> and the second sheet body <NUM>, a boundary between the blood collection bag <NUM> and the parent bag <NUM>, a boundary between the parent bag <NUM> and the child bag <NUM>, and a boundary between the child bag <NUM> and the medicinal solution bag <NUM> are separated from each other at respective cutting portions <NUM>. Instead of the cutting portions <NUM>, groove-shaped cuttable portions <NUM> which can be easily cut may also be provided (see <FIG>). In this case, the blood collection bag <NUM>, the parent bag <NUM>, the child bag <NUM>, and the medicinal solution bag <NUM> are provided in a state of being integrally connected via the cuttable portions <NUM>. The cuttable portions <NUM> can be easily cut by a user, whereby the blood collection bag <NUM>, the parent bag <NUM>, the child bag <NUM>, and the medicinal solution bag <NUM> can be separated immediately prior to being used.

The parent bag <NUM> serves both as a bag for accommodating the residual blood from which predetermined cells have been removed by the filter <NUM>, and a bag for storing a sedimentation component (concentrated red blood cells) obtained by centrifugally separating blood. The outlet-side flow path <NUM> is connected to an upper end part of the parent bag <NUM>, and blood flows into the interior 18b of the parent bag <NUM> via the outlet-side flow path <NUM>. Further, the parent bag <NUM> is equipped with connection ports <NUM> and a breakable member 32B at an upper portion thereof. The connection ports <NUM> comprise tubular members that penetrate through the sealed portion 18a, together with covers that cover the tubular members so as to be capable of being opened and closed. The breakable member 32B, in the same manner as the breakable member <NUM>, comprises a flow path configured to be capable of being opened by performing a breaking operation. The breakable member 32B penetrates through the sealed portion 18a, and is connected to one end of the transfer line <NUM>.

The child bag <NUM> serves as a bag for storing a supernatant component (blood plasma) obtained by subjecting the parent bag <NUM> to centrifugation. Connection ports <NUM> and the transfer line <NUM> are connected to an upper end part of the child bag <NUM>. The child bag <NUM> is connected to the parent bag <NUM> via the transfer line <NUM>.

The medicinal solution bag <NUM> accommodates the red blood cell storage solution <NUM> that is supplied to the parent bag <NUM>. As the red blood cell storage solution <NUM>, there may be used a MAP solution, a SAGM solution, an OPTISOL solution, or the like. Connection ports <NUM>, a breakable member 32C, and a tube <NUM> are connected to an upper end of the medicinal solution bag <NUM>. The transfer line <NUM> is connected to one end of the breakable member 32C. The breakable member 32C comprises a flow path that is opened by performing a breaking operation. The breakable member 32C places the transfer line <NUM> in communication with an interior 26b of the medicinal solution bag <NUM> by performing a breaking operation. The tube <NUM> is a tube for injecting the medicinal solution into the medicinal solution bag <NUM>, and a sealing member 38a thereof is sealed by being subjected to fusion bonding with a sealer or the like.

The transfer line <NUM> constitutes a flow path that connects the parent bag <NUM> and the child bag <NUM>, and also connects the parent bag <NUM> and the medicinal solution bag <NUM>. The illustrated transfer line <NUM> comprises a flow path 28a connected to the parent bag <NUM>, a flow path 28b connected to the child bag <NUM>, a flow path 28c connected to the medicinal solution bag <NUM>, and a branching part 28d of the flow path 28a, the flow path 28b, and the flow path 28c. The transfer line <NUM> is equipped with a sealed portion 28e where the first sheet body <NUM> and the second sheet body <NUM> are overlapped and fusion bonded on peripheral edges (both side parts) thereof. The transfer line <NUM> includes an interior portion 28f that allows liquid to flow through a portion surrounded by the sealed portion 28e. The first sheet body <NUM> and the second sheet body <NUM> that constitute the transfer line <NUM> are integrally connected to the portions constituting the parent bag <NUM>, the child bag <NUM>, and the medicinal solution bag <NUM>.

Hereinafter, a description will be given concerning a method of manufacturing the blood bag system <NUM> of the present embodiment.

In the blood bag system <NUM> according to the present embodiment, in order to reduce the number of fusion bonding steps (the number of joined parts due to fusion bonding), the blood collection bag <NUM>, the preprocessing unit <NUM>, and the separation processing unit <NUM> are integrally formed using the first sheet body <NUM> and the second sheet body <NUM>. Therefore, in the manufacturing method according to the present embodiment, the blood collection bag <NUM>, the parent bag <NUM>, the child bag <NUM>, and the medicinal solution bag <NUM>, as well as the inlet-side flow path <NUM>, the outlet-side flow path <NUM>, the transfer line <NUM>, and the filter accommodating unit <NUM> are formed at the same time.

First, as shown in <FIG>, the first sheet body <NUM> and the second sheet body <NUM>, which are rectangular shaped and are represented by the two-dot dashed lines and solid lines, are prepared. As shown in the drawing, the first sheet body <NUM> includes a first bag formation planned portion <NUM> where the blood collection bag <NUM> is formed, a second bag formation planned portion <NUM> where the parent bag <NUM> is formed, a preprocessing unit formation planned portion <NUM> where the preprocessing unit <NUM> is formed, a child bag formation planned portion <NUM> where the child bag <NUM> is formed, a third bag formation planned portion <NUM> where the medicinal solution bag <NUM> is formed, and a transfer line formation planned portion <NUM> where the transfer line <NUM> is formed. Among these portions, the preprocessing unit formation planned portion <NUM> includes a filter formation planned portion <NUM> in which the filter <NUM> is arranged. The second sheet body <NUM> is shaped into the same shape as the first sheet body <NUM>.

The first bag formation planned portion <NUM> is set to dimensions that include the sealed portion 14a (see <FIG>) on the peripheral edge of the blood collection bag <NUM>. Similarly, the second bag formation planned portion <NUM>, the child bag formation planned portion <NUM>, and the third bag formation planned portion <NUM> are set to dimensions that include the sealed portions. The preprocessing unit formation planned portion <NUM> and the transfer line formation planned portion <NUM> are set to dimensions having a wider range than the sealed portions of the flow paths <NUM> and <NUM> and the transfer line <NUM>.

Next, a shaping step of cutting the first sheet body <NUM> and shaping the first sheet body <NUM> into a shape surrounded by the contour shown by the solid line in the drawing is performed. In accordance with this step, the first sheet body <NUM> is formed into a shape of being constituted by the first bag formation planned portion <NUM>, the second bag formation planned portion <NUM>, the preprocessing unit formation planned portion <NUM>, the child bag formation planned portion <NUM>, the third bag formation planned portion <NUM>, and the transfer line formation planned portion <NUM>. The filter formation planned portion <NUM> is provided in the preprocessing unit formation planned portion <NUM>. Concerning the second sheet body <NUM> as well, it is formed in the same shape as the first sheet body <NUM>. More specifically, the second sheet body <NUM> is formed into a shape of being constituted by a first bag formation planned portion <NUM>, a second bag formation planned portion <NUM>, a preprocessing unit formation planned portion <NUM>, a child bag formation planned portion <NUM>, a third bag formation planned portion <NUM>, and a transfer line formation planned portion <NUM>. A filter arrangement planned portion <NUM> is provided in the preprocessing unit formation planned portion <NUM>. Shaping of the first sheet body <NUM> (and the second sheet body <NUM>) can be carried out by a method in which the first sheet body <NUM> (or the second sheet body <NUM>) is arranged on a flat lower mold, and then pressing a mold (upper mold) on which a cutting blade is formed at predetermined portions, from above. Further, shaping of the first sheet body <NUM> (and the second sheet body <NUM>) may be performed by various cutting methods starting with laser cutting or the like.

Next, as shown in <FIG>, a component arrangement step is performed of arranging the components required by the blood bag system <NUM> between the first sheet body <NUM> and the second sheet body <NUM>. In this instance, the connection ports <NUM> to be attached to the respective bags, the breakable members 32A to 32C, the tubes <NUM> and <NUM>, and the filter <NUM> that is mounted in the preprocessing unit <NUM> are arranged on the first sheet body <NUM>. The arrangement of the connection ports <NUM>, the breakable members 32A to 32C, and the tubes <NUM> and <NUM> is carried out using an arrangement jig <NUM>. The arrangement jig <NUM> is made of a conductive material such as metal or the like, and comprises a plurality of mounting pins <NUM> that project in one direction. The mounting pins <NUM> are disposed at positions where the connection ports <NUM>, the breakable members 32A to 32C, and the tubes <NUM> and <NUM> are arranged. The mounting pins <NUM> are formed with a thickness to enable the mounting pins <NUM> to be inserted into the connection ports <NUM>, the breakable members 32A to 32C, and the tubes <NUM> and <NUM>. The connection ports <NUM>, the breakable members 32A to 32C, and the tubes <NUM> and <NUM> are arranged on the first sheet body <NUM> in a state of being mounted on the mounting pins <NUM>. The connection ports <NUM>, the breakable members 32A to 32C, and the tubes <NUM> and <NUM> are arranged on the first sheet body <NUM> through sealing members <NUM> (see <FIG>) made of a thermoplastic resin or the like.

Further, the filter <NUM> is arranged on the first sheet body <NUM> in a state with filter arrangement jigs <NUM> being inserted into the inlet port 36a and the outlet port 36b that are joined to both ends of the filter. Similar to the arrangement jig <NUM>, a conductive material such as metal or the like can be used for the filter arrangement jigs <NUM>.

Next, the second sheet body <NUM> is overlaid on the first sheet body <NUM> on which the connection ports <NUM>, the breakable members 32A to 32C, and the tubes <NUM> and <NUM> are arranged. The second sheet body <NUM> is shaped into the same shape as the first sheet body <NUM>, and is equipped with the first bag formation planned portion <NUM>, the second bag formation planned portion <NUM>, the preprocessing unit formation planned portion <NUM>, the child bag formation planned portion <NUM>, the third bag formation planned portion <NUM>, and the transfer line formation planned portion <NUM>. Components such as the connection ports <NUM>, the breakable members 32A to 32C, and the tubes <NUM> and <NUM> are placed in abutment with the second sheet body <NUM> through the sealing members <NUM>. In the manner described above, arrangement of the components constituting the blood bag system <NUM> between the first sheet body <NUM> and the second sheet body <NUM> is completed.

Thereafter, a temporary fixing step is performed to fix the connection ports <NUM>, the breakable members 32A to 32C, the tubes <NUM> and <NUM>, and the filter <NUM>, which are disposed between the first sheet body <NUM> and the second sheet body <NUM>, to the first sheet body <NUM> and the second sheet body <NUM>. In this instance, as shown in the figures, these components are fixed between the first sheet body <NUM> and the second sheet body <NUM> using the sealing members <NUM> which are made of a thermoplastic resin. The sealing members <NUM> are disposed in a manner so as to cover the connection ports <NUM>, the breakable members 32A to 32C, the tubes <NUM> and <NUM>, and the ports 36a and 36b of the filter <NUM>. The arrangement positions of the sealing members <NUM> are arranged so as to overlap with the filter arrangement jigs <NUM> or the mounting pins <NUM> of the arrangement jig <NUM>.

Next, as shown in <FIG>, the components that are covered by the sealing members <NUM> are pressed by an upper mold <NUM>. Concave portions 98a having shapes corresponding to the outer peripheral shapes of the components at portions corresponding to the components are provided in the upper mold <NUM>, and the ports <NUM>, 36a, and 36b, the breakable members 32A (32B to 32C), and the tubes <NUM> and <NUM> can be pressed into close contact between the first sheet body <NUM> and the second sheet body <NUM> via the sealing members <NUM>.

Furthermore, a high (radio) frequency power supply <NUM> is connected between the arrangement jig <NUM> (including the filter arrangement jigs <NUM>) and the upper mold <NUM>, as well as between the arrangement jig <NUM> (including the filter arrangement jigs <NUM>) and a lower mold <NUM>. The high frequency power supply <NUM> applies a high frequency electric field between the mounting pins <NUM> and the upper mold <NUM>, and between the mounting pins <NUM> and the lower mold <NUM>, as well as to the first sheet body <NUM>, the sealing members <NUM>, and the second sheet body <NUM> provided between the upper mold <NUM> and the lower mold <NUM>. The high frequency electric field heats the first sheet body <NUM>, the sealing members <NUM>, and the second sheet body <NUM> to thereby fusion bond them. As a result, components such as the ports <NUM>, 36a, and 36b, the breakable members 32A to 32C, and the tubes <NUM> and <NUM> are fixed at predetermined positions between the first sheet body <NUM> and the second sheet body <NUM>.

Next, a fusion bonding step of fusion bonding the first sheet body <NUM> and the second sheet body <NUM> is performed. According to the present embodiment, as shown in <FIG>, portions (shaded areas) indicated by the oblique lines, which are peripheral edge portions of the first bag formation planned portion <NUM>, the second bag formation planned portion <NUM>, the preprocessing unit formation planned portion <NUM>, the child bag formation planned portion <NUM>, the third bag formation planned portion <NUM>, and the transfer line formation planned portion <NUM>, are subjected to fusion bonding while being sandwiched and pressed between a lower mold <NUM> and an upper mold <NUM> (see <FIG>).

In the fusion bonding step according to the present embodiment, as shown in <FIG>, in the upper mold <NUM>, cavities 104b are provided at portions constituting the flow paths <NUM> and <NUM>. The cavities 104b of the upper mold <NUM> have the shapes of the blank portions that are surrounded by hatching as shown in <FIG>. Further, in the upper mold <NUM>, the cavities 104b are also provided at portions constituting the interiors 14b, 18b, 24b, and 26b of the bags <NUM>, <NUM>, <NUM>, and <NUM>, and in the filter accommodating unit <NUM> in which the filter <NUM> is arranged. In the upper mold <NUM> of the present embodiment, the cavities 104b in the shape of the meandering sections 20A and 22A are provided at portions corresponding to the flow paths <NUM> and <NUM>.

As shown in the cross-sectional view of <FIG>, a pressing member 104a that presses the first sheet body <NUM> and the second sheet body <NUM> is formed to protrude on both side parts of the cavities 104b of the meandering section 22A. In addition, in the meandering section 22A, wedge-shaped protrusions 104c that protrude toward the lower mold <NUM> are provided in the pressing member 104a between the adjacent cavities 104b. Further, protrusions 102c, which protrude toward the protrusions 104c at portions facing toward the protrusions 104c, are provided in the lower mold <NUM>. Thin-walled cuttable portions <NUM> at the fusion-bonded portion (sealed portion 22a) between the first sheet body <NUM> and the second sheet body <NUM> are formed by such protrusions 102c and 104c. The lower mold <NUM> may also be formed in a flat shape without having the protrusions 102c formed thereon. In this case, the protrusions 104c of the one side form the cuttable portions <NUM>.

Further, the lower mold <NUM> is configured to comprise a flat pressing member 102a. Moreover, in the lower mold <NUM>, cavities may be formed therein at portions corresponding to the cavities 104b of the upper mold <NUM>. The first sheet body <NUM> and the second sheet body <NUM> are pressed from upper and lower directions by the pressing member 102a of the lower mold <NUM> and the pressing member 104a of the upper mold <NUM>. The pressing members 102a and 104a are provided at portions indicated by the oblique lines shown in <FIG>. Moreover, in the lower mold <NUM> and the upper mold <NUM>, at portions corresponding to the ports <NUM>, 36a, and 36b and the breakable members 32A to 32C, concave portions 102d and 104d are respectively provided having shapes corresponding to the outer peripheral shapes of the components, and are configured in a manner so as not to cause damage to such components.

As shown in <FIG>, in the other end of the first bag formation planned portion <NUM>, the second bag formation planned portion <NUM>, the child bag formation planned portion <NUM>, and the third bag formation planned portion <NUM>, nozzles <NUM> are arranged which supply compressed air between the first sheet body <NUM> and the second sheet body <NUM>. The nozzles <NUM> extend into portions of the cavities 102b and 104b of the lower mold <NUM> and the upper mold <NUM>.

Thereafter, compressed air is supplied through the nozzles <NUM> between the first sheet body <NUM> and the second sheet body <NUM>. As shown in <FIG>, the compressed air introduced from the nozzles <NUM> presses apart and separates the first sheet body <NUM> and the second sheet body <NUM> inside the cavities 104b. The compressed air introduced into the second bag formation planned portion <NUM> is also introduced into portions corresponding to the outlet-side flow path <NUM>, the filter accommodating unit <NUM>, and the inlet-side flow path <NUM>, whereby the first sheet body <NUM> and the second sheet body <NUM> of these portions are pressed apart and separated. Further, the compressed air introduced into the child bag formation planned portion <NUM> presses apart and separates the first sheet body <NUM> and the second sheet body <NUM> at portions corresponding to the transfer line <NUM>.

Thereafter, while compressed air is supplied between the first sheet body <NUM> and the second sheet body <NUM>, as shown in <FIG>, the high frequency power supply <NUM> applies the high frequency electric field through the lower mold <NUM> and the upper mold <NUM>, to the pressed portions of the first sheet body <NUM> and the second sheet body <NUM>. Consequently, the first sheet body <NUM> and the second sheet body <NUM> are heated at the portions pressed by the pressing members 102a and 104a, and both of the bodies are fusion bonded. Due to the fusion bonding step, predetermined positions of the first sheet body <NUM> and the second sheet body <NUM> are fusion bonded by the sealed portions, and the blood collection bag <NUM>, the inlet-side flow path <NUM>, the filter accommodating unit <NUM>, the outlet-side flow path <NUM>, the parent bag <NUM>, the child bag <NUM>, the medicinal solution bag <NUM>, and the transfer line <NUM> are integrally formed. Further, the meandering sections 20A and 22A are formed in the flow paths <NUM> and <NUM>, respectively. As shown in <FIG>, in the meandering section 22A, the cuttable portions <NUM>, which are thin-walled grooves, are formed between adjacently disposed portions of the flow path <NUM>. Similar cuttable portions <NUM> are also formed in the meandering section 20B. Components such as the ports <NUM>, 36a and 36b, the breakable members 32A to 32C, and the tubes <NUM> and <NUM> are also fusion bonded to the first sheet body <NUM> and the second sheet body <NUM> at the same time. Thereafter, the nozzles <NUM> are pulled out from between the first sheet body <NUM> and the second sheet body <NUM>, and the peripheral edges of the first sheet body <NUM> and the second sheet body <NUM> at the portions where the nozzles <NUM> were arranged are fusion bonded, thereby completing the fusion bonding step. After completion of the fusion bonding step, the first sheet body <NUM> and the second sheet body <NUM> are removed from the lower mold <NUM> and the upper mold <NUM>.

Next, as shown in <FIG>, a cutting step is performed to cut away superfluous sealed portions of the first sheet body <NUM> and the second sheet body <NUM>. In this instance, the cuttable portions <NUM> are formed by the wedge-shaped protrusions 104c at portions shown by the one-dot dashed lines in the figure, and the seal portions can be easily cut and separated along the cuttable portions <NUM>. In the example shown in <FIG>, the cutting process is completed by removing the portions (shaded areas) indicated by the oblique lines. Cutting of the sealed portions may be performed, for example, using a mold having a cutting blade of a predetermined shape. Further, in the cutting step, boundaries between the blood collection bag <NUM>, the parent bag <NUM>, the child bag <NUM>, and the medicinal solution bag <NUM> are cut and separated at the cutting portions <NUM>. Moreover, instead of completely cutting the boundaries between the blood collection bag <NUM>, the parent bag <NUM>, the child bag <NUM>, and the medicinal solution bag <NUM>, a configuration may be provided in which the cuttable portions <NUM> are left intact, and are cut and separated immediately prior to use.

Thereafter, as shown in <FIG>, predetermined medicinal solutions are injected into the blood collection bag <NUM> and the medicinal solution bag <NUM>. The anticoagulant <NUM> for the blood collection bag <NUM> is injected into the interior 14b of the blood collection bag <NUM> via the blood collection tube <NUM>. Further, the red blood cell storage solution <NUM> for the medicinal solution bag <NUM> is injected into the interior 26b of the medicinal solution bag <NUM> via the tube <NUM>.

As shown in <FIG>, after injection of the medicinal solutions is completed, the breakable member <NUM> and the blood collection unit <NUM> are attached to the blood collection tube <NUM>. Further, the tube <NUM> is cut and fusion bonded by a sealer or the like, and is sealed by the sealing member 38a.

By way of the steps described above, manufacturing of the blood bag system <NUM> is completed. Next, a description will be given in outline concerning a method of using the blood bag system <NUM>.

In the blood bag system <NUM>, blood (whole blood) is accommodated in the blood collection bag <NUM> through the blood collection unit <NUM>. Thereafter, the user cuts and seals the blood collection tube <NUM> with a sealer, and separates the blood collection unit <NUM>.

Next, a breaking operation is carried out on the breakable member 32A to thereby transfer the blood components of the blood collection bag <NUM> into the parent bag <NUM>. As shown in <FIG>, the cuttable portions <NUM> provided in the meandering sections 20A and 22A of the flow paths <NUM> and <NUM> are cut and separated, and then the flow paths <NUM> and <NUM>, which are in a folded state, are pulled and extended. At this time, the cuttable portions <NUM> are separated by pulling the flow paths <NUM> and <NUM>, and the flow paths <NUM> and <NUM> are deformed from the meandering shape into a linearly extended shape. In addition, the blood collection bag <NUM> is arranged on the upper side, and the parent bag <NUM>, which is the transfer destination for the blood, is arranged on the lower side. Since the flow paths <NUM> and <NUM> are placed in a linear shape, a large difference in elevation can be generated between the blood collection bag <NUM> and the parent bag <NUM>. Consequently, due to the difference in elevation between the blood collection bag <NUM> and the parent bag <NUM>, the whole blood from the blood collection bag <NUM> is transferred into the parent bag <NUM> while passing through the filter <NUM>. At this time, leukocytes and blood platelets are removed by the filter <NUM> from the blood that is transferred from the blood collection bag <NUM>. Thereafter, by cutting and fusion bonding the flow path <NUM> with a sealer, the user separates the blood collection bag <NUM> and the filter <NUM> (the preprocessing unit <NUM>) from the separation processing unit <NUM>.

Thereafter, the separation processing unit <NUM> is set in a centrifugal separation device. In the centrifugal separation device, a centrifugal force is applied to the parent bag <NUM> to thereby separate the blood inside the parent bag <NUM> into a supernatant component of blood plasma and a sedimentation component of concentrated red blood cells, together with transferring the supernatant component of the blood platelets through the transfer line <NUM> into the child bag <NUM>. The centrifugal separation device automatically transfers the supernatant component through the transfer line <NUM>. Thereafter, the flow path 28b on the side of the child bag <NUM> is closed with a clamp, and the red blood cell storage solution <NUM> is transferred through the transfer line <NUM> into the parent bag <NUM>, whereupon the centrifugation process of the blood components is completed.

The blood bag system <NUM> and the method of manufacturing the same according to the present embodiment exhibit the following advantageous effects.

The blood bag system <NUM> according to the present embodiment is equipped with the plurality of bags in which blood is accommodated, and the flow paths that connect the plurality of bags. In addition, the blood bag system <NUM> includes the main body portion, which is integrally formed by the first sheet body <NUM>, and the second sheet body <NUM> that is superimposed on the first sheet body <NUM>. The main body portion includes the first bag (blood collection bag <NUM>) in which the blood is accommodated, the second bag (parent bag <NUM>) in which a blood component contained in the blood is accommodated, the first flow paths (flow paths <NUM> and <NUM>) connecting the first bag (blood collection bag <NUM>) and the second bag (parent bag <NUM>), and the meandering sections 20A and 22A in which portions of the first flow paths (flow paths <NUM> and <NUM>) are repeatedly folded back on themselves, and adjacent portions of the first flow paths (flow paths <NUM> and <NUM>) are fusion bonded to each other, wherein the fusion bonded portions of the first flow paths (flow paths <NUM> and <NUM>) of the meandering sections 20A and 22A are connected via the thin-walled cuttable portions <NUM> that are capable of being separated. In this manner, since the flow paths <NUM> and <NUM> can be formed in a folded state by the meandering sections 20A and 22A, the elongate flow paths <NUM> and <NUM> can be formed using the first sheet body <NUM> and the second sheet body <NUM> which are configured in a compact manner. Consequently, the device configuration used for manufacturing the blood bag system <NUM> can be reduced in size.

The above-described blood bag system <NUM> may further include the filter accommodating unit <NUM> which is disposed in the first flow paths (flow paths <NUM> and <NUM>), and in which there is accommodated the filter <NUM> configured to remove the predetermined component from the blood. In this case, the meandering sections 20A and 22A may be disposed in at least one of before or after the filter accommodating unit <NUM>. Consequently, by extending the meandering sections 20A and 22A, a sufficient difference in elevation can be generated between the blood collection bag <NUM> and the parent bag <NUM>, and the blood can be reliably transferred from the blood collection bag <NUM> into the parent bag <NUM>.

In the above-described blood bag system <NUM>, the cuttable portions <NUM> are separated by pulling the flow paths <NUM> and <NUM>, and the flow paths <NUM> and <NUM> are deformed from the meandering shape into a linearly extended shape. In accordance with this feature, a sufficient difference in elevation can be generated between the blood collection bag <NUM> and the parent bag <NUM>.

In the method of manufacturing the blood bag system <NUM> according to the present embodiment, the blood bag system <NUM> is equipped with the first bag (blood collection bag <NUM>) in which blood is accommodated, the second bag (parent bag <NUM>) in which blood components separated from the blood are accommodated, and the first flow paths (flow paths <NUM> and <NUM>) connecting the first bag (blood collection bag <NUM>) and the second bag (parent bag <NUM>), wherein the first bag (blood collection bag <NUM>), the second bag (parent bag <NUM>), and the first flow paths (flow paths <NUM> and <NUM>) are integrally formed by the first sheet body <NUM>, and the second sheet body <NUM> that is superimposed on the first sheet body <NUM>, and the first flow paths (flow paths <NUM> and <NUM>) include the meandering sections 20A and 22A that are repeatedly folded back on themselves. The method of manufacturing the blood bag system includes the step of preparing the first sheet body <NUM> in which the first bag formation planned portion <NUM>, the second bag formation planned portion <NUM>, and the preprocessing unit formation planned portion <NUM> are integrally connected, and the second sheet body <NUM> in which the first bag formation planned portion <NUM>, the second bag formation planned portion <NUM>, and the preprocessing unit formation planned portion <NUM> are integrally connected, the superimposing step of superimposing the second sheet body <NUM> on the first sheet body <NUM>, and the fusion bonding step of fusion bonding the first sheet body <NUM> and the second sheet body <NUM> at peripheral edge portions of the first bag formation planned portions <NUM> and <NUM>, the second bag formation planned portions <NUM> and <NUM>, and the preprocessing unit formation planned portions <NUM> and <NUM> while blowing air between the first sheet body <NUM> and the second sheet body <NUM>, to thereby form the first bag (blood collection bag <NUM>), the second bag (parent bag <NUM>), and the first flow paths (flow paths <NUM> and <NUM>) respectively in the first bag formation planned portions <NUM> and <NUM>, the second bag formation planned portions <NUM> and <NUM>, and the preprocessing unit formation planned portions <NUM> and <NUM>, wherein, in the fusion bonding step, the meandering sections 20A and 22A of the first flow paths (flow paths <NUM> and <NUM>) that are repeatedly folded back on themselves are formed in the preprocessing unit formation planned portions <NUM> and <NUM>.

In accordance with the above-described configuration, even though the flow paths <NUM> and <NUM> become elongated, since they can be formed in a folded state, the first sheet body <NUM> and the second sheet body <NUM> may be kept small in size.

In the above-described method of manufacturing the blood bag system <NUM>, in the fusion bonding step, while the upper mold <NUM> (mold) having the meandering cavities 104b is placed in contact with the first sheet body and the second sheet body, and the first sheet body and the second sheet body are separated from one another inside the cavities 104b by air, the meandering sections 20A and 22A may be formed by fusion bonding portions adjacent to the cavities 104b. By blowing air into the cavities 104b in such a manner, the complex meandering flow paths <NUM> and <NUM> can be reliably formed.

In the above-described method of manufacturing the blood bag system <NUM>, the upper mold <NUM> (mold) includes the wedge-shaped protrusions 104c at portions corresponding to the areas between adjacent portions of the flow paths <NUM> and <NUM> of the meandering sections 20A and 22A, and by performing fusion bonding while pressing the protrusions 104c against the first sheet body <NUM> and the second sheet body <NUM>, the thin-walled cuttable portions <NUM> which are capable of being separated can be formed between the adjacent portions of the flow paths <NUM> and <NUM> of the meandering sections 20A and 22A. In accordance with such a configuration, the cuttable portions <NUM> can be formed at the same time as the fusion bonding, and the manufacturing process can be simplified.

In the above-described method of manufacturing the blood bag system <NUM>, the first sheet body <NUM> and the second sheet body <NUM> may further include the filter arrangement planned portion <NUM> in which the filter <NUM> configured to remove predetermined cells is provided, and the meandering sections 20A and 22A of the flow paths <NUM> and <NUM> may be formed in at least one of between the blood collection bag <NUM> and the filter accommodating unit <NUM> and between the filter accommodating unit <NUM> and the parent bag <NUM>. In accordance with such features, the elongate flow paths <NUM> and <NUM> can be provided between the blood collection bag <NUM> and the parent bag <NUM>, and it is possible to manufacture the blood bag system <NUM> that brings about the large difference in elevation between the blood collection bag <NUM> and the parent bag <NUM>.

Claim 1:
A blood bag system (<NUM>) equipped with a plurality of bags in which blood is accommodated, and flow paths (<NUM>, <NUM>) connecting the plurality of bags, the blood bag system (<NUM>) comprising:
a main body portion integrally formed by a first sheet body (<NUM>), and a second sheet body (<NUM>) that is superimposed on the first sheet body (<NUM>);
wherein the main body portion comprises:
a first bag (<NUM>) in which the blood is accommodated;
a second bag (<NUM>) in which a blood component contained in the blood is accommodated;
a first flow path (<NUM>, <NUM>) connecting the first bag (<NUM>) and the second bag (<NUM>); and
a meandering section (20A, 22A) in which portions of the first flow path (<NUM>, <NUM>) are repeatedly folded back on themselves, and adjacent portions of the first flow path (<NUM>, <NUM>) are fusion bonded to each other;
wherein the fusion bonded portions of the first flow path (<NUM>, <NUM>) of the meandering section (20A, 22A) are connected via thin-walled cuttable portions (<NUM>) configured to be separable.