Patent Description:
Various bag-shaped containers formed by fusion bonding resin sheets have been proposed. For example, in <CIT>, a blood collection bag in the form of a bag-shaped container is disclosed. In such a bag-shaped container, there are cases in which a flow path for injection or removal of contents is connected to the bag-shaped container, and in such a flow path, a sealing member is provided in order to seal the bag-shaped container.

In <CIT>, a flow path sealing member is disclosed in which a breakable closing member is provided in the interior of a tubular member that possesses flexibility. The flow path sealing member can be opened by a user bending the tubular member and causing the closing member to break.

Document <CIT> discloses a container with sub-chambers separated by peelable seal. Here, a container comprising a first side wall and a second side wall that are permanently joined by at least one seam such that a chamber is formed between the side walls. A peelable seal separates the chamber into a first sub-chamber and a second subchamber that are capable of receiving liquid contents, which may be mixed if the peelable seal is opened. The seam comprises a protrusion that extends into the chamber, and the peelable seal extends over the protrusion.

<CIT> discloses a multi-constituent packaging with applicator. Here, a packaging for at least two constituents has a tubular or bag-shaped packaging element and an applicator having a dispensing channel for the mixed constituents and being connectable to the packaging element, wherein the packaging element is designed for storing at least one constituent and for mixing the at least two constituents. This makes it possible to create a packaging for two or a plurality of constituents that can be mixed together and applied in a simple manner in a metered administration. In a preferred embodiment of the invention the two constituents (or a plurality of constituents) are accommodated jointly in a single flexible (tubular or bag-like) packaging, which also serves as a mixing chamber, whereas the applicator only fulfills its function as an application aid. Document <CIT> relates to a multi-chamber medical bag, which is capable of obtaining a positive mixture of medicines, prior to the discharge thereof. A weak seal is provided for dividing the space inside the medical bag into left-handed and right-handed partitions. The weak seal has a first portion extending between the partitions and a bifurcated one adjacent to and faced with an outlet port. Additional strong seals are arranged on both sides of the second portion and extend at right angle to the first portion toward the strong seal at the outer periphery of the medical bag. When the partition is pressed, the resultant inflated deformation of the medical bag is mainly directed to the first portion due to the existence of the additional strong seals, which allows the last portion to be separated, resulting in a mixing of the medicines in the partitions. The second portion is the opened one, which allows the mixed medicines to be introduced into the outlet port. [Summary of Invention].

Since such a conventional flow path sealing member is composed of a plurality of component parts, a process of assembling the plurality of component parts is required. Further, a step of fusion bonding the flow path sealing structure to the bag-shaped container is required. Therefore, in the case that such a conventional flow path sealing member is provided in the flow path, a problem arises in that manufacturing costs are increased.

As a method of suppressing manufacturing costs, it may be considered to form the bag-shaped container and the flow path integrally by fusion bonding a pair of resin sheets, together with providing a weakly sealed portion on the flow path to thereby integrally form the flow path sealing member with the resin sheets.

However, it is difficult to control the sealing strength of the weakly sealed portion, and even if manufactured under the same conditions, it has been ascertained that there is a possibility that defective products may be produced in which leakage of fluid occurs due to the sealing strength being insufficient, or in which the sealing strength is too strong and the flow path sealing member cannot be opened.

One aspect of the present invention has the object of providing a flow path sealing structure, a bag-shaped container, and a method of manufacturing the same, in which it is possible to reduce manufacturing costs, and to achieve stable product quality.

The one aspect of the present invention is a flow path sealing structure, which is disposed on a way of a flow path formed by fusion bonding a pair of resin sheets that are superimposed on each other, the flow path sealing structure including a widened portion surrounded by a widened seal portion formed by fusion bonding the pair of resin sheets around a periphery thereof, and one end and another end of which are in communication with the flow path, the widened portion being formed to be wider than the flow path, and a weakly sealed portion formed to extend in a widthwise direction in the widened portion, and which partitions the widened portion in a liquid-tight and airtight manner into a first region on a side of the one end and a second region on a side of the other end, the weakly sealed portion configured to be opened by increasing an internal pressure of the widened portion.

Another aspect of the present invention is a bag-shaped container which is provided with the flow path sealing structure according to the above-described aspect.

A still further aspect of the present invention is a method of manufacturing a flow path sealing structure, including a step of superimposing a pair of resin sheets in a thickness direction, a first fusion bonding step of fusion bonding the pair of resin sheets to thereby form a flow path, and a widened portion disposed on a way of the flow path and which is formed to be wider than the flow path, and a second fusion bonding step of fusion bonding the resin sheets of the widened portion to thereby form a weakly sealed portion that crosses in a widthwise direction, wherein, in the second fusion bonding step, fusion bonding is carried out under a condition in which an amount of input heat per unit area is less than in the first fusion bonding step.

A still further aspect of the present invention is a method of manufacturing a bag-shaped container, including a step of superimposing a pair of resin sheets in a thickness direction, a first fusion bonding step of fusion bonding the pair of resin sheets to thereby form an accommodating section, a flow path, and a widened portion disposed on a way of the flow path and which is formed to be wider than the flow path, and a second fusion bonding step of fusion bonding the resin sheets of the widened portion to thereby form a weakly sealed portion that crosses in a widthwise direction, wherein, in the second fusion bonding step, fusion bonding is carried out under a condition in which an amount of input heat per unit area is less than in the first fusion bonding step.

A still further aspect of the present invention is a blood bag system, including a blood collection bag in which whole blood is collected, a parent bag in which centrifugal separation of the whole blood is carried out, a child bag in which a portion of a separated blood component is accommodated, a medicinal solution bag in which a storage solution for the blood component is accommodated, a first flow path configured to connect the blood collection bag and the parent bag, and a second flow path configured to connect the parent bag, the child bag, and the medicinal solution bag, wherein the blood collection bag, the parent bag, the child bag, the medicinal solution bag, the first flow path, and the second flow path are integrally formed by fusion bonding a pair of resin sheets, and there is provided a flow path sealing structure disposed in at least one of the paths of the first flow path and the second flow path, the flow path sealing structure including a widened portion surrounded by a widened seal portion formed by fusion bonding the pair of resin sheets around a periphery thereof, and one end and another end of which are in communication with the flow path, the widened portion being formed to be wider than the flow path, and a weakly sealed portion formed to extend in a widthwise direction in the widened portion, and which partitions the widened portion in a liquid-tight and airtight manner into a first region on a side of the one end and a second region on a side of the other end, the weakly sealed portion configured to be opened by increasing an internal pressure of the widened portion.

A still further aspect of the present invention is a sample collecting structure for a bag-shaped container, including a flow path connected to the bag-shaped container in which an accommodating section is formed in an interior thereof, and which is placed in communication with the accommodating section, a sample container connected to the bag-shaped container via the flow path, and a flow path sealing structure disposed on a way of the flow path and configured to seal the flow path, wherein the flow path, the sample container, and the flow path sealing structure are formed integrally with the bag-shaped container by fusion bonding a pair of resin sheets, the flow path sealing structure including a widened portion surrounded by a widened seal portion formed by fusion bonding the pair of resin sheets around a periphery thereof, and one end and another end of which are in communication with the flow path, the widened portion being formed to be wider than the flow path, and a weakly sealed portion formed to extend in a widthwise direction in the widened portion, and which partitions the widened portion in a liquid-tight and airtight manner into a first region on a side of the one end and a second region on a side of the other end, the weakly sealed portion configured to be opened by increasing an internal pressure of the widened portion.

The flow path sealing structure, the bag-shaped container, and the method of manufacturing the same according to the above-described aspects are capable of reducing manufacturing cost and bringing about stable product quality.

Preferred embodiments of the present invention will be presented and described in detail below with reference to the accompanying drawings. Moreover, in the present specification, a direction along a center line of the flow path is referred to as a flow path direction, whereas a direction perpendicular to such a direction is referred to as a widthwise direction of such a portion.

A flow path sealing structure <NUM> according to the present embodiment is disposed on the way of flow paths <NUM>, which are obtained by superimposing a pair of resin sheets <NUM> and <NUM> on each other and subjecting them to fusion bonding, and is formed integrally with the flow paths <NUM> by the resin sheets <NUM> and <NUM>. The flow path sealing structure <NUM> seals the flow paths <NUM> so that they are capable of being opened at a weakly sealed portion <NUM>, and is maintained in a state in which the flow paths <NUM> are sealed in an initial state. The flow path sealing structure <NUM> can be opened by sending a pressurized fluid into the flow path sealing structure <NUM> via one or both of the flow paths <NUM>. Such a flow path sealing structure <NUM> is used in connection with the flow paths, for example, of a medicinal solution bag, or a blood bag system or the like.

The resin sheets <NUM> and <NUM> that constitute the flow paths <NUM> and the flow path sealing structure <NUM> are constituted by a thermoplastic resin that is soft and possesses flexibility, such as polyvinyl chloride resin, polyurethane resin, EVA (ethylene-vinyl acetate copolymer) resin, or the like. The resin sheets <NUM> and <NUM> are superimposed on each other in a thickness direction.

The flow paths <NUM> include flow path sealed portions 16a and flow through portions 16b formed between the flow path sealed portions 16a. The flow path sealed portions 16a form both side portions of the flow paths <NUM> and extend along the flow paths <NUM>. The flow path sealed portions 16a are constituted by a strong seal in which the resin sheets <NUM> and <NUM> are completely fusion bonded. The strong seal is a seal of a state in which an interface <NUM> between the two resin sheets <NUM> and <NUM> has completely disappeared. The dimension of the flow path sealed portions 16a in a widthwise direction perpendicular to a center line of the flow paths <NUM> is set, for example, on the order of <NUM> to <NUM>.

Both sides of the flow through portions 16b of the flow paths <NUM> are sealed by the flow path sealed portions 16a, and are sealed by the resin sheets <NUM> and <NUM> in the thickness direction. As shown in <FIG>, the resin sheets <NUM> and <NUM> of the flow through portions 16b are shaped so as to bulge out apart from each other in the thickness direction. The width of the flow through portions 16b can be appropriately set according to the desired flow rate, and can be formed, for example, on the order of <NUM> to <NUM>.

As shown in <FIG>, the flow path sealing structure <NUM> is provided on the way of the flow path <NUM>, and is equipped with a widened portion <NUM> that is wider than the flow paths <NUM> in the widthwise direction (a direction perpendicular to the flow path direction and the thickness direction of the resin sheets <NUM> and <NUM>), and a weakly sealed portion <NUM> that is formed across the widened portion <NUM>. Although the thickness of the widened portion <NUM> is substantially the same as the thickness of the flow paths <NUM>, the thickness thereof is not limited to this feature. The widened portion <NUM> may be formed to be enlarged in the thickness direction of the flow paths <NUM> by locally changing the direction of the fusion bonded pattern in the vicinity of the widened portion <NUM>. The widened portion <NUM> is formed in a circular shape as viewed in plan, and a widened seal portion <NUM> is formed along the peripheral edge part thereof.

As shown in <FIG>, the widened seal portion <NUM> is constituted by a strong seal in which the resin sheets <NUM> and <NUM> are completely fusion bonded together. The widened seal portion <NUM> includes a semicircular arcuate portion 22a that constitutes one side portion, and a semicircular arcuate portion 22b that constitutes another side portion. The arcuate portion 22a is connected to one of the flow path sealed portions 16a of the flow paths <NUM>. Further, the arcuate portion 22b is connected to another one of the flow path sealed portions 16a of the flow paths <NUM>. The width of the widened seal portion <NUM> itself may be approximately the same as the width of the flow path sealed portions 16a.

As shown in <FIG>, a circular interior part 20c is formed at a portion surrounded by the widened seal portion <NUM>. As shown in <FIG> and <FIG>, the interior part 20c is covered with the resin sheets <NUM> and <NUM> in the thickness direction. The resin sheets <NUM> and <NUM> bulge in a manner so as to separate away from each other in the thickness direction, and form a hollow portion or cavity. The interior part 20c communicates with the flow paths <NUM> at one end and another end thereof in the flow path direction.

As shown in <FIG>, the interior part 20c is partitioned by the weakly sealed portion <NUM> in a liquid-tight and airtight manner into a first region 20a and a second region 20b. The first region 20a communicates with the flow path <NUM> on one end side in the flow path direction, and the second region 20b communicates with the flow path <NUM> on the other end side. As shown in <FIG>, the weakly sealed portion <NUM> is provided in close proximity to the center of the widened portion <NUM> in the flow path direction, and is formed across the widened portion <NUM> in the widthwise direction.

The weakly sealed portion <NUM> is formed by fusion bonding the resin sheets <NUM> and <NUM>, and as shown in <FIG>, the two resin sheets <NUM> and <NUM>, which are superimposed on each other in the thickness direction, are fusion bonded in a state with an interface <NUM> left remaining therebetween. As will be described later, the weakly sealed portion <NUM> can be formed by being carried out under a condition in which the amount of input heat per unit area (sealing power) when the resin sheets <NUM> and <NUM> are fusion bonded is less than the amount of input heat per unit area when the strong seal is fusion bonded.

As shown in <FIG>, the dimension of the weakly sealed portion <NUM> in the flow path direction (the vertical width in the drawing) is formed to be less than the width of the widened seal portion <NUM> or the flow path sealed portions 16a. More preferably, the weakly sealed portion <NUM> may have a concavely curved shape as viewed in plan, so that a dimension thereof in the flow path direction becomes smaller toward the center in the widthwise direction. Moreover, the weakly sealed portion <NUM> is not limited to being arranged in a direction perpendicular to the flow path direction, and may be inclined with respect to the flow path direction.

The flow path sealing structure <NUM> according to the present embodiment is constituted in the manner described above. Next, operations thereof will be described below.

The flow path sealing structure <NUM> is disposed on the way of the flow paths <NUM>, and in an initial state, the weakly sealed portion <NUM> partitions one and another one of the flow paths <NUM> in a liquid-tight and airtight manner, whereby a fluid such as the medicinal solution and blood or the like is prevented from flowing.

Further, the flow path sealing structure <NUM> can be opened by supplying a pressurized fluid to the flow path sealing structure <NUM> through a bag-shaped container <NUM> or a pump that is connected to the flow paths <NUM>. At that time, by the pressurized fluid flowing into the widened portion <NUM>, the resin sheets <NUM> and <NUM> shown in <FIG> are pushed and spread apart in the thickness direction. As a result, at the weakly sealed portion <NUM>, the interface <NUM> (see <FIG>) between the resin sheets <NUM> and <NUM> is displaced in a manner so as to be peeled apart, and the flow path sealing structure <NUM> is opened.

Next, a description will be given concerning a method of manufacturing the flow path sealing structure <NUM> according to the present embodiment.

The flow path sealing structure <NUM> of the present embodiment is manufactured by a two-step fusion bonding process with differing amounts of input heat. More specifically, the flow path sealed portions 16a and the widened seal portion <NUM> are formed in the first fusion bonding step, and the weakly sealed portion <NUM> is formed in the second fusion bonding step. Prior to the first fusion bonding step, as shown in <FIG>, the resin sheet <NUM> and the resin sheet <NUM> are superimposed on each other in the thickness direction. In addition, the superimposed resin sheets <NUM> and <NUM> are transported inwardly between a lower mold <NUM> and an upper mold <NUM>.

The lower mold <NUM> includes pressing parts 26a that protrude from a main surface 26d, and cavities 26b and 26c formed between the pressing parts 26a. The pressing parts 26a are formed at a portion corresponding to the flow path sealed portions 16a of the flow paths <NUM>, and the widened seal portion <NUM> of the widened portion <NUM>. The cavity 26b is provided in a portion corresponding to the interior part 20c of the widened portion <NUM>, and is formed in a recessed (concave) cylindrical shape. The cavity 26c is provided in a portion corresponding to the flow through portions 16b of the flow paths <NUM>, and has a cross-section that is formed in a recessed (concave) arcuate shape.

The upper mold <NUM> is formed vertically symmetrical with the lower mold <NUM>, and includes pressing parts 28a that protrude from a main surface 28d, and cavities 28b and 28c formed between the pressing parts 28a. The pressing parts 28a are disposed in a portion of the lower mold <NUM> that faces toward the pressing parts 26a. Further, the cavities 28b and 28c are disposed in portions of the lower mold <NUM> that face respectively toward the cavities 26b and 26c.

Next, the lower mold <NUM> and the upper mold <NUM> press the pair of resin sheets <NUM> and <NUM>. Consequently, portions of the resin sheets <NUM> and <NUM> that are sandwiched between the pressing parts 26a of the lower mold <NUM> and the pressing parts 28a of the upper mold <NUM> are placed in close contact with each other. Thereafter, pressurized air is injected between the resin sheets <NUM> and <NUM> and into the portion surrounded by the pressing parts 26a and 28a. Consequently, the resin sheet <NUM> bulges toward the cavities 28b, 28c of the upper mold <NUM>. Further, the resin sheet <NUM> bulges toward the cavities 26b, 26c of the lower mold <NUM>.

Next, high frequency electrical power is supplied between the upper mold <NUM> and the lower mold <NUM> to thereby perform the first fusion bonding step. The portions of the resin sheets <NUM> and <NUM> that are pressed from above and below by the pressing parts 26a of the lower mold <NUM> and the pressing parts 28a of the upper mold <NUM> are heated and fusion bonded together by the high frequency electrical power. Consequently, as shown in <FIG>, the flow paths <NUM>, and the widened portion <NUM> where the pair of resin sheets <NUM> and <NUM> are fusion bonded together are formed. Further, the resin sheets <NUM> and <NUM> at the flow paths <NUM>, and the widened portion <NUM> are shaped in a bulging shape by being fusion bonded while pressurized air is supplied thereto.

Next, the second fusion bonding step is performed. As shown in <FIG>, the second fusion bonding step is carried out using a lower mold <NUM> having a pressing part 30a at a portion corresponding to the weakly sealed portion <NUM>, and an upper mold <NUM> having a pressing part 32a at a portion facing toward the pressing part 30a. The structure shown in <FIG> is arranged between the lower mold <NUM> and the upper mold <NUM>. Thereafter, portions of the resin sheets <NUM> and <NUM> corresponding to the weakly sealed portion <NUM> are sandwiched between the pressing parts 30a and 32a. Then, high frequency electrical power is supplied between the lower mold <NUM> and the upper mold <NUM> to thereby fusion bond the resin sheets <NUM> and <NUM> that are sandwiched between the pressing parts 30a and 32a.

By adjusting the electrical power supplied to the lower mold <NUM> and the upper mold <NUM>, the second fusion bonding step is carried out under a condition in which the amount of input heat per unit area of the fusion bonded portion is less than in the first fusion bonding step. Consequently, the resin sheets <NUM> and <NUM> are fusion bonded in a state in which the interface <NUM> (see <FIG>) is left remaining therebetween, and the weakly sealed portion <NUM> having an appropriate sealing strength is formed. In the manner described above, manufacturing of the flow path sealing structure <NUM> according to the present embodiment is completed.

Hereinafter, a description will be given concerning the result of producing the flow path sealing structure <NUM> having various dimensions, and examining a relationship between heating conditions in the second fusion bonding step and the sealing strength. In this instance, the diameter (width) of the widened portion <NUM> is variously changed, and an evaluation of the sealing strength of the weakly sealed portion <NUM> is performed when the electrical power (input heat) supplied in the second fusion bonding step is changed within a range of <NUM> to <NUM> W. The sealing strength of the weakly sealed portion <NUM> was evaluated by determining a pressure (opening pressure) when the weakly sealed portion <NUM> breaks upon supplying fluid from the one flow path <NUM>. An appropriate opening pressure for the flow path sealing structure <NUM> of the present embodiment was evaluated as being appropriate when the lower limit thereof was within a range on the order of <NUM> MPa and an upper limit thereof was within a range on the order of <NUM> MPa. When the opening pressure is less than a value in proximity to <NUM> MPa, since the sealing strength starts to become insufficient, a concern arises in that opening may easily occur in the case that an unintended load acts thereon during handling. Further, when the opening pressure exceeds a value in proximity to <NUM> MPa, it becomes difficult for opening to occur even if a pressure is applied thereto by the operator, and ease of handling tends to deteriorate.

In Exemplary Embodiment <NUM>, the diameter (width) of the widened portion <NUM> was set to <NUM>. In Exemplary Embodiment <NUM>, the diameter (width) of the widened portion <NUM> was set to <NUM>. Further, in Exemplary Embodiment <NUM>, the diameter (width) of the widened portion <NUM> was set to <NUM>. Further, in Exemplary Embodiment <NUM>, the diameter (width) of the widened portion <NUM> was set to <NUM>. On the other hand, in the Comparative Example, without providing the widened portion <NUM>, only the weakly sealed portion <NUM> was provided in the flow path <NUM>. Moreover, in Exemplary Embodiments <NUM> to <NUM> and the Comparative Example, the width of the flow paths <NUM> was <NUM>, and the average dimension of the weakly sealed portion <NUM> in the flow path direction was <NUM>.

The results of Exemplary Embodiments <NUM> to <NUM> and the Comparative Example are shown in <FIG>. As shown in the graph, in the case that the widened portion <NUM> is provided, it was understood that the sealing strength of the weakly sealed portion <NUM> gradually changes accompanying an increase in the electrical power supplied in the second fusion bonding step. Accordingly, in Exemplary Embodiments <NUM> to <NUM>, due to the electrical power supplied in the second fusion bonding step, it was possible to confirm that the weakly sealed portions <NUM> of various sealing strengths can be formed, and the weakly sealed portion <NUM> having a desired sealing strength can be manufactured.

In the foregoing manner, by providing the widened portion <NUM> in the flow path sealing structure <NUM>, manufacturing of the weakly sealed portion <NUM> of a desired sealing strength is made possible.

Moreover, by locally modifying the materials or their mixing ratio of the resin sheets <NUM> and <NUM> on the inner side of the widened portion <NUM> that is capable of constituting the weakly sealed portion <NUM> so as to be made different from the materials or their mixing ratio of other portions, the weakly sealed portion <NUM> may be controlled in a manner so that the sealing strength of the weakly sealed portion <NUM> becomes weaker than the sealing strength of the other portions. In this case, there is no need to perform fusion bonding twice with differing amounts of input heat, and the weakly sealed portion <NUM> can be formed by a single fusion bonding step.

The flow path sealing structure <NUM> according to the present embodiment exhibits the following advantageous effects.

The flow path sealing structure <NUM> of the present embodiment is characterized by the flow path sealing structure <NUM>, which is disposed on the way of the flow path <NUM> formed by fusion bonding the pair of resin sheets <NUM> and <NUM> that are superimposed on each other, and includes the widened portion <NUM> surrounded by the widened seal portion <NUM> formed by fusion bonding the pair of resin sheets <NUM> and <NUM> around the periphery thereof, and the one end and the other end of which are in communication with the flow path <NUM>, the widened portion <NUM> being formed to be wider than the flow path <NUM>, and the weakly sealed portion <NUM> formed to extend in the widthwise direction in the widened portion <NUM>, and which partitions the widened portion <NUM> in a liquid-tight and airtight manner into the first region 20a on the side of the one end and the second region 20b on the side of the other end, the weakly sealed portion <NUM> configured to be opened by increasing the internal pressure of the widened portion <NUM>.

In accordance with the above-described constitution, the ability to control the sealing strength of the weakly sealed portion <NUM> can be improved, and it is possible to form the weakly sealed portion <NUM> with an appropriate sealing strength. Consequently, the flow path sealing structure <NUM>, which is capable of reliably sealing the flow paths <NUM> and can be easily opened when necessary, can be integrally manufactured in the resin sheets <NUM> and <NUM> together with the flow paths <NUM>.

In the above-described flow path sealing structure <NUM>, the weakly sealed portion <NUM> may be fusion bonded in a state in which the interface <NUM> is left remaining between the pair of resin sheets <NUM> and <NUM>. In accordance with this feature, the flow path sealing structure <NUM> can be easily opened.

In the above-described flow path sealing structure <NUM>, the dimension of the weakly sealed portion <NUM> in a direction (the flow path direction) perpendicular to the widthwise direction may be formed in a curving manner so as to become smaller toward the center in the widthwise direction. In accordance with such constitution, the resin sheets <NUM> and <NUM> adjacent to the weakly sealed portion <NUM> are likely to bulge in a manner so as to separate away from each other due to the pressure of the fluid, and the ability to control the sealing strength is further improved.

In the above-described flow path sealing structure <NUM>, the widened portion <NUM> may be formed in a circular shape as viewed in plan. In accordance with such constitution, the resin sheets <NUM> and <NUM> adjacent to the weakly sealed portion <NUM> become likely to bulge, and control of the sealing strength is facilitated.

In the above-described flow path sealing structure <NUM>, at the widened portion <NUM>, the pair of resin sheets <NUM> and <NUM> may bulge in a manner so as to separate away from each other in the thickness direction. In accordance with such constitution, because the resin sheets <NUM> and <NUM> are likely to bulge when a pressure is applied thereto, control of the sealing strength is facilitated.

In the above-described flow path sealing structure <NUM>, the first region 20a and the second region 20b need not necessarily be made to bulge. In accordance with such constitution, if there is a bulge, stresses will continue to be applied to the weakly sealed portion <NUM>, and there is a possibility that pealing apart may take place. By making the first region 20a and the second region 20b flat, application of stress to the sealed portion can be eliminated.

The method of manufacturing a flow path sealing structure <NUM> according to the present embodiment includes the step of superimposing the pair of resin sheets <NUM> and <NUM> in the thickness direction, the first fusion bonding step of fusion bonding the pair of resin sheets <NUM> and <NUM> to thereby form the flow path <NUM>, and the widened portion <NUM> disposed on the way of the flow path <NUM> and which is formed to be wider than the flow path <NUM>, and the second fusion bonding step of fusion bonding the resin sheets <NUM> and <NUM> of the widened portion <NUM> to thereby form the weakly sealed portion <NUM> that crosses in the widthwise direction, wherein, in the second fusion bonding step, fusion bonding is carried out under a condition in which the amount of input heat per unit area is less than in the first fusion bonding step.

In the above-described method of manufacturing the flow path sealing structure <NUM>, since the method can be realized simply by adding the second fusion bonding step of forming the weakly sealed portion <NUM> to the first fusion bonding step of forming the flow paths <NUM>, the flow path sealing structure <NUM> can be formed with a fewer number of process steps than in a conventional flow path sealing structure in which the assembly of separate members is required. Further, by providing the weakly sealed portion <NUM> in the widened portion <NUM>, the weakly sealed portion <NUM> can be formed with an appropriate sealing strength.

In the above-described method of manufacturing the flow path sealing structure <NUM>, in the weakly sealed portion <NUM>, the resin sheets <NUM> and <NUM> may be in close contact with the interface <NUM> left remaining therebetween. In accordance with this feature, the flow path sealing structure <NUM> which is capable of being reliably opened when needed is obtained.

In the above-described method of manufacturing the flow path sealing structure <NUM>, the constituent materials of the resin sheets <NUM> and <NUM> that constitute the weakly sealed portion <NUM> may be controlled. In this case, the weakly sealed portion <NUM> may be formed at the same time as the first fusion bonding step, and with the same amount of heat input per area as other seal portions. Further, in this case as well, in the second fusion bonding step, the weakly sealed portion <NUM> may be formed with a smaller amount of input heat.

As shown in <FIG>, the bag-shaped container <NUM> according to the present embodiment includes a main body portion <NUM>, the flow paths <NUM> that communicate with the main body portion <NUM>, and the flow path sealing structure <NUM> disposed on the way of the flow paths <NUM>. The bag-shaped container <NUM>, for example, is a container for medical use in which a medicinal solution or the like is stored therein, and the flow paths <NUM> are used for introducing a liquid into the bag-shaped container <NUM>, or for discharging the liquid from the bag-shaped container <NUM>. In the bag-shaped container <NUM>, the main body portion <NUM>, the flow paths <NUM>, and the flow path sealing structure <NUM> are integrally formed by the pair of resin sheets <NUM> and <NUM>. Moreover, concerning structural features that are the same as those of the flow paths <NUM> and the flow path sealing structure <NUM> shown in <FIG>, they are designated by the same reference numerals, and detailed description of such features is omitted.

The main body portion <NUM> is formed in a substantially rectangular shape, and includes a peripheral edge sealed portion <NUM> formed by fusion bonding a peripheral edge part thereof, and an accommodating section <NUM> formed on an inner side of the peripheral edge sealed portion <NUM>. The peripheral edge sealed portion <NUM> is constituted by a strong seal in which the resin sheets <NUM> and <NUM> are completely fusion bonded. The peripheral edge sealed portion <NUM> closes the peripheral edge part of the main body portion <NUM>, together with being divided at a communicating section <NUM>.

The accommodating section <NUM> is formed between the pair of resin sheets <NUM> and <NUM>, and in the portion that is sealed by the peripheral edge sealed portion <NUM>. The accommodating section <NUM> communicates with the flow paths <NUM> at the communicating section <NUM>. Liquid contents are accommodated in the accommodating section <NUM>.

A flow path formation unit <NUM> projects from one end of the main body portion <NUM>. The flow path formation unit <NUM> is a portion in which the flow paths <NUM> and the flow path sealing structure <NUM> are formed, and is constituted by the resin sheets <NUM> and <NUM> which are integrally connected to the main body portion <NUM>. The flow paths <NUM> communicate with the accommodating section <NUM>, and the flow paths <NUM> are sealed by the flow path sealing structure <NUM>. The flow path sealed portions 16a on both sides of the flow paths <NUM> are connected to the peripheral edge sealed portion <NUM> on both sides of the communicating section <NUM>. In the flow path sealing structure <NUM>, when the main body portion <NUM> is pressed, the weakly sealed portion <NUM> breaks and opens.

In the bag-shaped container <NUM> according to the present embodiment, in order to prevent the weakly sealed portion <NUM> of the flow path sealing structure <NUM> from being inadvertently broken due to an increase in the internal pressure of the accommodating portion <NUM> when autoclave sterilization is performed or when subjected to handling or the like, an opening prevention member <NUM> is attached to the flow path formation unit <NUM>. The opening prevention member <NUM> is disposed at a position overlapping the weakly sealed portion <NUM> of the flow path sealing structure <NUM>, and by being placed in abutment from both sides in the thickness direction of the weakly sealed portion <NUM>, the resin sheets <NUM> and <NUM> at a location in close proximity to the weakly sealed portion <NUM> are prevented from rising upward, and breakage of the weakly sealed portion <NUM> is prevented. The opening prevention member <NUM> is a clamp equipped with a pair of rod-shaped holding members 50a, and holds the resin sheets <NUM> and <NUM> by an elastic biasing force of the holding members 50a. In use, the opening prevention member <NUM> can be easily removed by pulling off the holding members 50a from the resin sheets <NUM> and <NUM>. Moreover, it should be noted that the opening prevention member <NUM> is not limited to such an illustrated clamp, and may be constituted so as to press the weakly sealed portion <NUM> by being formed integrally with a packaging body in which the bag-shaped container <NUM> is accommodated.

Hereinafter, a description will be given concerning a method of manufacturing the bag-shaped container <NUM> of the present embodiment.

First, the pair of resin sheets <NUM> and <NUM> are prepared, and the resin sheets <NUM> and <NUM> are superimposed on each other in the thickness direction. Next, the superimposed resin sheets <NUM> and <NUM> are sandwiched between a lower mold and an upper mold of a predetermined shape, and the portion shown in hatching in <FIG> is pressed. In addition, a first fusion bonding step is carried out in which high frequency electrical power is supplied between the lower mold and the upper mold to thereby fusion bond the portion shown in hatching, and thereby form the peripheral edge sealed portion <NUM>, the flow path sealed portions 16a, and the widened seal portion <NUM>.

The first fusion bonding step is performed under a condition in which fusion takes place until the interface <NUM> between the resin sheets <NUM> and <NUM> disappears. Further, in the first fusion bonding step, as shown in the drawing, a nozzle <NUM> is inserted between the resin sheets <NUM> and <NUM>, and by supplying high pressure air from the nozzle <NUM>, fusion bonding is carried out while the portions surrounded by the peripheral edge sealed portion <NUM>, the flow path sealed portions 16a, and the widened seal portion <NUM> are made to undergo bulging. The nozzle <NUM> is pulled out after fusion bonding of the other peripheral edge part is completed, and the portion where the nozzle <NUM> is inserted is fusion bonded to complete the first fusion bonding step.

Thereafter, a trimming step of cutting off an excess portion of the resin sheets <NUM> and <NUM> is performed. The trimming step is performed by placing the structure shown in <FIG> inside a mold provided with a cutting blade, and cutting and removing the excess portion. Moreover, instead of the trimming step, cutting blades for cutting off the excess portion of the resin sheets <NUM> and <NUM> may be provided on the lower mold and the upper mold that were used in the first fusion bonding step, and simultaneously with the resin sheets <NUM> and <NUM> being pressed by the lower mold and the upper mold, the main body portion <NUM> and the flow path formation unit <NUM> may be formed into predetermined shapes.

Thereafter, as necessary, a medicinal solution injection step of injecting a medicinal solution into the accommodating section <NUM> via the flow paths <NUM> is performed. In the case that the bag-shaped container <NUM> is manufactured in the form of an empty bag, the medicinal solution injection step is not performed.

Next, as shown in <FIG>, a second fusion bonding step is performed in order to form the weakly sealed portion <NUM> in the widened portion <NUM>. The second fusion bonding step can be performed by the same method that was described with reference to <FIG>. Consequently, as shown in <FIG>, the weakly sealed portion <NUM> is formed, and the flow path sealing structure <NUM> is completed. The accommodating section <NUM> is sealed by the flow path sealing structure <NUM>. In accordance with the above procedure, the basic constitution of the bag-shaped container <NUM> is completed.

Thereafter, as shown in <FIG>, an opening prevention member <NUM> is attached to a portion that overlaps the weakly sealed portion <NUM>. In addition, the bag-shaped container <NUM> to which the opening prevention member <NUM> has been attached is inserted into an autoclave device, and autoclave sterilization is carried out. During autoclave sterilization, the internal pressure of the accommodating section <NUM> of the bag-shaped container <NUM> rises, however, the opening prevention member <NUM> prevents opening of the flow path sealing structure <NUM>. In accordance with the above procedure, the method of manufacturing the bag-shaped container <NUM> of the present embodiment is brought to an end.

The bag-shaped container <NUM> of the present embodiment exhibits the following advantageous effects.

The bag-shaped container <NUM> of the present embodiment is characterized by the bag-shaped container <NUM> including the peripheral edge sealed portion <NUM> obtained by fusion bonding the pair of resin sheets <NUM> and <NUM> that are superimposed on each other, the accommodating section <NUM> surrounded by the peripheral edge sealed portion <NUM>, the flow path <NUM> formed by fusion bonding the pair of resin sheets <NUM> and <NUM> and which are placed in communication with the accommodating section <NUM>, and the flow path sealing structure <NUM> disposed on the way of the flow path <NUM>, the flow path sealing structure <NUM> including the widened portion <NUM> surrounded by the widened seal portion <NUM> formed by fusion bonding the pair of resin sheets <NUM> and <NUM> around the periphery thereof, and the one end and the other end of which are in communication with the flow path <NUM>, the widened portion <NUM> being formed to be wider than the flow path <NUM>, and the weakly sealed portion <NUM> formed to extend in the widthwise direction in the widened portion <NUM>, and which partitions the widened portion <NUM> in a liquid-tight and airtight manner into the first region 20a on the side of the one end and the second region 20b on the side of the other end, the weakly sealed portion <NUM> configured to be opened by increasing the internal pressure of the widened portion <NUM>.

In accordance with the above-described constitution, since the flow paths <NUM> and the flow path sealing structure <NUM> are formed integrally with the bag-shaped container <NUM>, production efficiency is superior. Further, by being equipped with the flow path sealing structure <NUM> in which the weakly sealed portion <NUM> is provided in the widened portion <NUM>, the ability to control the sealing strength is excellent.

In the above-described bag-shaped container <NUM>, the weakly sealed portion <NUM> may be fusion bonded in a state in which the interface <NUM> (see <FIG>) is left remaining between the pair of resin sheets <NUM> and <NUM>. In accordance with this feature, the flow path sealing structure <NUM> can be easily opened by pressing the bag-shaped container <NUM>.

In the above-described bag-shaped container <NUM>, the dimension of the weakly sealed portion <NUM> in a direction perpendicular to the widthwise direction may be formed in a curving manner so as to become smaller toward the center in the widthwise direction. Further, in the bag-shaped container <NUM>, the widened portion <NUM> may be formed in a circular shape as viewed in plan. Further, in the bag-shaped container <NUM>, at the widened portion <NUM>, the pair of resin sheets <NUM> and <NUM> may bulge so as to separate away from each other in the thickness direction. In accordance with the above-described constitution, the resin sheets <NUM> and <NUM> at a location in close proximity to the weakly sealed portion <NUM> are likely to bulge, and the ability to control the sealing strength of the weakly sealed portion <NUM> is improved.

In the above-described bag-shaped container <NUM>, there may further be provided the opening prevention member <NUM> that prevents the weakly sealed portion <NUM> from separating in the thickness direction. In accordance with this feature, even in the case that the internal pressure of the accommodating section <NUM> increases during autoclave sterilization, opening of the flow path sealing structure <NUM> can be prevented.

The method of manufacturing the bag-shaped container <NUM> according to the present embodiment includes the step of superimposing the pair of resin sheets <NUM> and <NUM> in the thickness direction, the first fusion bonding step of fusion bonding the pair of resin sheets <NUM> and <NUM> to thereby form the accommodating section <NUM>, the flow path <NUM>, and the widened portion <NUM> disposed on the way of the flow path <NUM> and which is formed to be wider than the flow path <NUM>, and the second fusion bonding step of fusion bonding the resin sheets <NUM> and <NUM> of the widened portion <NUM> to thereby form the weakly sealed portion <NUM> that crosses in the widthwise direction, wherein, in the second fusion bonding step, fusion bonding is carried out under a condition in which the amount of input heat per unit area is less than in the first fusion bonding step. In accordance with the above-described manufacturing method, since the method can be realized simply by adding the second fusion bonding step of forming the weakly sealed portion <NUM> to the first fusion bonding step of forming the accommodating section <NUM>, the flow paths <NUM>, and the widened portion <NUM>, the flow path sealing structure <NUM> can be added to the bag-shaped container <NUM> with a fewer number of process steps than in a conventional flow path sealing structure in which the assembly of separate members is required. Further, by providing the weakly sealed portion <NUM> in the widened portion <NUM>, the weakly sealed portion <NUM> can be formed with an appropriate sealing strength.

In the above-described method of manufacturing the bag-shaped container <NUM>, in the weakly sealed portion <NUM>, the resin sheets <NUM> and <NUM> may be fusion bonded with the interface <NUM> (see <FIG>) left remaining therebetween. In accordance with this feature, the flow path sealing structure <NUM> which is capable of being reliably opened when needed is obtained.

In the above-described method of manufacturing the bag-shaped container <NUM>, there may further be included the step of heat sterilizing (autoclave sterilizing) the accommodating section <NUM>, the flow path <NUM>, and the widened portion <NUM> after the second fusion bonding step, and the heat sterilization step may be performed by attaching to the weakly sealed portion <NUM> the opening prevention member <NUM> that prevents the weakly sealed portion <NUM> from separating in the thickness direction. In accordance with this feature, even if the internal pressure of the accommodating section <NUM> rises during heat sterilization, breakage of the weakly sealed portion <NUM> can be prevented.

In accordance with the above-described method of manufacturing the bag-shaped container <NUM>, the flow paths <NUM> and the flow path sealing structure <NUM> can be formed together with the bag-shaped container <NUM>, simply by adding the second fusion bonding step of forming the weakly sealed portion <NUM> to the first fusion bonding step of forming the peripheral edge sealed portion <NUM> of the bag-shaped container <NUM>. Consequently, the flow path sealing structure <NUM> can be formed in the bag-shaped container <NUM> with a fewer number of process steps than in a conventional flow path sealing structure in which the assembly of separate members is required. Further, by providing the weakly sealed portion <NUM> in the widened portion <NUM>, the weakly sealed portion <NUM> can be formed with an appropriate sealing strength.

According to the present embodiment, a description will be given concerning a method of opening the flow path sealing structure <NUM> shown in <FIG>, as well as a transfer method of transferring fluid from the bag-shaped container <NUM>. Moreover, in the following description, concerning constituent features that are the same as those of the bag-shaped container <NUM> shown in <FIG>, they are designated by the same reference numerals, and detailed description of such features is omitted. The method of the present embodiment is performed using a transfer device <NUM> as shown in <FIG>. The transfer device <NUM>, for example, is a device that constitutes a part of a blood sampling device or a centrifugal separation device, and by opening the flow path sealing structure <NUM> of the bag-shaped container <NUM> which has been set therein, is capable of transferring the fluid accommodated in the accommodating section <NUM>.

As shown in the drawing, the transfer device <NUM> includes a pump <NUM>, a control unit <NUM>, and a sensor <NUM>. The pump <NUM>, for example, is a peristaltic pump, and is equipped with a rotor <NUM>. The flow path <NUM> that extends from the bag-shaped container <NUM> is installed on the rotor <NUM> of the pump <NUM>. By undergoing peristaltic motion, the rotor <NUM> is capable of transferring the fluid inside the flow paths <NUM>.

The sensor <NUM>, for example, is an optical sensor, and detects a component of the fluid inside the flow paths <NUM>. The sensor <NUM> may also be a pressure sensor that detects the internal pressure of the flow paths <NUM>. The control unit <NUM> controls operation of the pump <NUM> based on the detection result of the sensor <NUM>.

Transferring of the fluid from the bag-shaped container <NUM> by the transfer device <NUM> is performed in the following manner. First, the flow paths <NUM> of the bag-shaped container <NUM> are set in the pump <NUM>, and the opening prevention member <NUM> (see <FIG>), which is attached to the flow path sealing structure <NUM>, is removed.

Next, under the control of the control unit <NUM>, the pump <NUM> is operated to rotate the rotor <NUM> in the direction of the arrow. Consequently, a pressurized fluid (for example, air) is sent into the flow path sealing structure <NUM> via the flow paths <NUM>. By a predetermined pressure being applied to the flow path sealing structure <NUM>, the resin sheets <NUM> and <NUM> in close proximity to the weakly sealed portion <NUM> bulge in a manner so as to be peeled apart, and the weakly sealed portion <NUM> is broken. Consequently, the flow path sealing structure <NUM> is opened.

The sensor <NUM> detects a change in the fluid component, and based thereon, the control unit <NUM> detects the opening of the flow path sealing structure <NUM>. When the opening of the flow path sealing structure <NUM> is detected, the control unit <NUM> reverses the direction in which the rotor <NUM> of the pump <NUM> rotates.

As shown in <FIG>, by the rotor <NUM> rotating in the direction of the arrow, transferring of the fluid is started. The fluid contained in the bag-shaped container <NUM> is transferred by the pump <NUM> to the exterior through the flow paths <NUM>. A predetermined amount of the fluid is transferred, whereupon transferring of the fluid is completed.

In the foregoing manner, according to the transfer device <NUM> of the present embodiment, it is possible for opening of the flow path sealing structure <NUM> and transferring of the fluid in the bag-shaped container <NUM> to be carried out.

The method of opening the flow path sealing structure <NUM> according to the present embodiment and the transfer method of transferring the fluid exhibit the following advantageous effects.

In the method of opening the flow path sealing structure <NUM> according to the present embodiment, the flow path sealing structure <NUM> is disposed on the way of the flow path <NUM> formed by fusion bonding the pair of resin sheets <NUM> and <NUM> that are superimposed on each other, and includes the widened portion <NUM> surrounded by the widened seal portion <NUM> formed by fusion bonding the pair of resin sheets <NUM> and <NUM> around the periphery thereof, and one end and another end of which are in communication with the flow path <NUM>, the widened portion <NUM> being formed to be wider than the flow path <NUM>, and the weakly sealed portion <NUM> formed to extend in the widthwise direction in the widened portion <NUM>, and which partitions the widened portion <NUM> in a liquid-tight and airtight manner into the first region 20a on the side of the one end and the second region 20b on the side of the other end, the weakly sealed portion <NUM> configured to be opened by increasing the internal pressure of the widened portion <NUM>, the method of opening the flow path sealing structure <NUM> including the step of connecting the pump <NUM> to the flow path <NUM>, and the step of sending the pressurized fluid into the widened portion <NUM> through the pump <NUM>, and causing the pair of resin sheets <NUM> and <NUM> that constitute the weakly sealed portion <NUM> to separate. According to such a method of opening, the fluid, which has been pressurized by the pump <NUM>, is sent therein, whereby opening of the flow path sealing structure <NUM> can be performed without the need for human intervention.

The transfer method according to the present embodiment is a transfer method applied to the bag-shaped container <NUM>, the bag-shaped container <NUM> including the peripheral edge sealed portion <NUM> obtained by fusion bonding the pair of resin sheets <NUM> and <NUM> that are superimposed on each other, the accommodating section <NUM> surrounded by the peripheral edge sealed portion <NUM>, the flow path <NUM> formed by fusion bonding the pair of resin sheets <NUM> and <NUM> and which are placed in communication with the accommodating section <NUM>, and the flow path sealing structure <NUM> disposed on the way of the flow path <NUM>, the flow path sealing structure <NUM> including the widened portion <NUM> surrounded by the widened seal portion <NUM> formed by fusion bonding the pair of resin sheets <NUM> and <NUM> around the periphery thereof, and the one end and the other end of which are in communication with the flow path <NUM>, the widened portion <NUM> being formed to be wider than the flow path <NUM>, and the weakly sealed portion <NUM> formed to extend in the widthwise direction in the widened portion <NUM>, and which partitions the widened portion <NUM> in a liquid-tight and airtight manner into the first region 20a on the side of the one end and the second region 20b on the side of the other end, the weakly sealed portion <NUM> configured to be opened by increasing the internal pressure of the widened portion <NUM>. Such a transfer method includes the step of connecting the pump <NUM> to the flow path <NUM>, the step of sending the pressurized fluid toward the flow path sealing structure <NUM> and into the accommodating section <NUM> through the pump <NUM>, and causing the pair of resin sheets <NUM> and <NUM> that constitute the weakly sealed portion <NUM> of the flow path sealing structure <NUM> to separate, and the step of reversing the pump <NUM> and causing the fluid in the accommodating section <NUM> to flow out from the accommodating section <NUM>. In accordance with these features, opening of the flow path sealing structure <NUM> of the bag-shaped container <NUM>, and transferring of the fluid in the accommodating portion <NUM> can be performed without the need for human intervention.

A description will be given concerning a blood bag system <NUM> according to the present embodiment, which is used for collecting and separating blood for use in products or for use in blood transfusions. Moreover, concerning constituent features that are the same as those of the flow path sealing structure <NUM> shown in <FIG>, they are designated by the same reference numerals, and detailed description of such features is omitted.

As shown in <FIG>, the 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 constituted 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 by dividing them 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> in which collected whole blood is accommodated, a preprocessing unit that removes predetermined blood components from the whole blood, a parent bag <NUM> and a child bag <NUM> in which remaining blood components from which predetermined components have been removed are centrifugally separated and divided into a plurality of blood components that are accommodated therein, and a medicinal solution bag <NUM> for supplying a red blood cell storage solution <NUM> to the parent bag <NUM>.

The blood collection unit <NUM> is equipped with tubes <NUM> and <NUM>, a branch connector <NUM>, a breakable member <NUM>, a blood collection needle <NUM>, and an initial flow blood bag <NUM>.

The branch connector <NUM> is equipped with first to third ports. The blood collection needle <NUM> is connected to the first port, the initial flow blood bag <NUM> is connected to the second port, and the third port is connected to the blood collection bag <NUM> via the breakable member <NUM> and the tube <NUM>. The blood collection needle <NUM> has a needle tip that is punctured into the skin of the donor, and is a part into which blood from the donor flows when blood collection from the donor is carried out.

The initial flow of blood when blood is collected flows through the second port 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.

The tube <NUM> is connected to the third port of the branch connector <NUM>, and the other end is connected to one end of the breakable member <NUM>. The breakable member <NUM> is constituted 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 tube <NUM> to the other end of the breakable member <NUM>. The breakable member <NUM> is subjected to the breaking operation after the initial flow of blood is collected in the initial flow blood bag <NUM>. The whole blood collected from the donor flows into the blood collection bag <NUM> through the opened breakable member <NUM>. The tube <NUM> is made from a thermoplastic resin or the like, and together with being fusion bonded and sealed by a tube sealer or the like, is constituted to be cut after the completion of blood collection.

The blood collection bag <NUM> is formed in a bag shape by superimposing the pair of resin sheets <NUM> and <NUM>, and fusion bonding (heat fusion bonding or high frequency fusion bonding) a peripheral edge sealed portion 72a of the peripheral edge part. Further, it is preferable that the resin sheets <NUM> and <NUM> use transparent or translucent resin sheets <NUM> and <NUM>, in order to facilitate optical discrimination between blood plasma and the concentrated red blood cells when the blood components are transferred through a later-described second flow path <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.

The tube <NUM> and a flow path 80a are connected to the blood collection bag <NUM>. The flow path 80a communicates with an accommodating section 72b of the blood collection bag <NUM>. The flow path sealing structure <NUM> is disposed on the way of the flow path 80a, and the flow path 80a is sealed by the flow path sealing structure <NUM> in an initial state.

The preprocessing unit includes a filter <NUM> for removing predetermined cells, an inlet-side flow path 80a, and an outlet-side flow path 80b. The inlet-side flow path 80a and the outlet-side flow path 80b constitute a first flow path <NUM> connecting the blood collection bag <NUM> and a parent bag <NUM>. The inlet-side flow path 80a is a flow path for transferring blood collected from the donor from the blood collection bag <NUM> to the filter <NUM>.

The outlet-side flow path 80b is a flow path for transferring the blood that has passed through the filter <NUM> to the parent bag <NUM>. The outlet-side flow path 80b and the inlet-side flow path 80a are formed by fusion bonding the resin sheets <NUM> and <NUM>, and are integrally connected to the blood collection bag <NUM>.

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. The filter <NUM> may be constituted in a manner so as to also capture platelets. The filter <NUM> is disposed between the resin sheets <NUM> and <NUM>, and is sealed on the inner side of a filter sealed portion <NUM> formed by being fusion bonded along a peripheral edge part thereof.

In the same manner as the blood collection bag <NUM>, the parent bag <NUM>, the child bag <NUM>, and the medicinal solution bag <NUM> are formed by superimposing the pair of resin sheets <NUM> and <NUM>, and are integrally connected to each other via the second flow path <NUM>. 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 (rich red blood cells) obtained by centrifugally separating blood. The parent bag <NUM> is provided with a peripheral edge sealed portion 74a where a peripheral edge part thereof is subjected to fusion bonding, and an accommodating section 74b is formed on the inner side thereof. The outlet-side flow path 80b and the second flow path <NUM> are connected to the upper end of the parent bag <NUM>.

The second flow path <NUM> is a flow path that is formed by fusion bonding the resin sheets <NUM> and <NUM>, and is formed by being integrally connected to the parent bag <NUM> and the like. The second flow path <NUM> is connected to the parent bag <NUM>, together with being connected to the child bag <NUM> and the medicinal solution bag <NUM> via a branching member <NUM>. In the second flow path <NUM>, the flow path sealing structure <NUM> is provided respectively in the vicinity of the parent bag <NUM> and the medicinal solution bag <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. The second flow path <NUM> is connected to the upper end of the child bag <NUM>. The child bag <NUM> is connected to the parent bag <NUM> via the second flow path <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. The second flow path <NUM> and the tube <NUM> are connected to the upper end of the medicinal solution bag <NUM>. The tube <NUM> is a tube for injecting the medicinal solution into the medicinal solution bag <NUM>, and is subjected to fusion bonding and sealed by a sealer or the like.

The blood collection bag <NUM>, the parent bag <NUM>, the child bag <NUM>, and the medicinal solution bag <NUM> are separated from each other at cutting portions <NUM>. The respective bags are integrally connected via the first flow path <NUM> and the second flow path <NUM>.

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 tube <NUM> with a sealer, and separates the blood collection unit <NUM>. Next, an opening operation is carried out on the flow path sealing structure <NUM>, and the blood components of the blood collection bag <NUM> are transferred to the parent bag <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 outlet-side flow path 80b with a sealer, the user separates the blood collection bag <NUM> and the filter <NUM> from the parent bag <NUM>.

The parent bag <NUM>, the child bag <NUM>, and the medicinal solution bag <NUM> are set in the 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 red blood cells, together with transferring the supernatant component of the blood platelets through the second flow path <NUM> into the child bag <NUM>. The centrifugal separation device automatically opens the flow path sealing structure <NUM> provided in the second flow path <NUM>, and transfers the supernatant component. Thereafter, a part of the second flow path <NUM> that extends toward the child bag <NUM> via the branching member <NUM> is closed by a clamp. In addition, the red blood cell storage solution <NUM> in the medicinal solution bag <NUM> is transferred to the parent bag <NUM> through the second flow path <NUM>, whereupon the centrifugation process for the blood components is completed.

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

First, the pair of resin sheets <NUM> and <NUM> which are formed in a predetermined shape are prepared, and the resin sheets <NUM> and <NUM> are superimposed on each other in the thickness direction. When the resin sheets <NUM> and <NUM> are superimposed, it is preferable that the filter <NUM>, the tubes <NUM> and <NUM>, and the like be positioned and temporarily fixed at predetermined positions beforehand.

Next, a first fusion bonding step is performed, and the resin sheets <NUM> and <NUM> are subjected to fusion bonding with a strong seal. More specifically, fusion bonding is carried out on the peripheral edge sealed portions 72a, 74a, 76a, and 78a, the fusion bonded portion of the first flow path <NUM>, the fusion bonded portion of the second flow path <NUM>, and the widened seal portion <NUM> (see <FIG>) of the flow path sealing structure <NUM>. In the first fusion bonding step, as shown in <FIG>, the resin sheets <NUM> and <NUM> are sandwiched between the upper mold and the lower mold having a protruding portion at the fusion bonded portion, and while high pressure air is supplied to the region surrounded by the fusion bonded portion, fusion bonding is carried out by supplying high frequency electrical power to the lower mold and the upper mold.

Thereafter, a second fusion bonding step is carried out in order to form the weakly sealed portion <NUM> of the flow path sealing structure <NUM>. The second fusion bonding step can be performed by the method described with reference to <FIG>.

Thereafter, the anticoagulant <NUM> is injected into the blood collection bag <NUM> via the tube <NUM>. After injection of the anticoagulant <NUM> is completed, the breakable member <NUM> and the blood collection unit <NUM> are attached to the tube <NUM>. Further, the red blood cell storage solution <NUM> is injected into the medicinal solution bag <NUM> via the tube <NUM>. After injection of the red blood cell storage solution <NUM> is completed, the tube <NUM> is cut and sealed with a sealer.

In accordance with the above procedure, the basic constitution of the blood bag system <NUM> is completed. Thereafter, autoclave sterilization is carried out on the blood bag system <NUM>. When autoclave sterilization is carried out, it is preferable to attach an opening prevention member <NUM> (see <FIG>) in order to prevent opening of the flow path sealing structure <NUM>. In accordance with the above procedure, manufacturing of the blood bag system <NUM> is completed.

Moreover, in the above-described blood bag system <NUM>, the weakly sealed portion <NUM> can be opened by the operator squeezing the bag to thereby raise the internal pressure.

The blood bag system <NUM> of the present embodiment exhibits the following advantageous effects.

The blood bag system <NUM> according to the present embodiment is characterized by the blood bag system <NUM> including the blood collection bag <NUM> in which whole blood is collected, the parent bag <NUM> in which centrifugal separation of the whole blood is carried out, the child bag <NUM> in which a portion of the separated blood component is accommodated, the medicinal solution bag <NUM> in which the red blood cell storage solution <NUM> for the blood component is accommodated, the first flow path <NUM> configured to connect the blood collection bag <NUM> and the parent bag <NUM>, and the second flow path <NUM> configured to connect the parent bag <NUM>, the child bag <NUM>, and the medicinal solution bag <NUM>, wherein the blood collection bag <NUM>, the parent bag <NUM>, the child bag <NUM>, the medicinal solution bag <NUM>, the first flow path <NUM>, and the second flow path <NUM> are integrally formed by fusion bonding the pair of resin sheets <NUM> and <NUM>, and there is provided the flow path sealing structure <NUM> disposed in at least one of the paths of the first flow path <NUM> and the second flow path <NUM>, the flow path sealing structure <NUM> including the widened portion <NUM> surrounded by the widened seal portion <NUM> formed by fusion bonding the pair of resin sheets <NUM> and <NUM> around the periphery thereof, and the one end and the other end of which are in communication with the flow path <NUM> or <NUM>, the widened seal portion <NUM> being formed to be wider than the flow path <NUM> or <NUM>, and the weakly sealed portion <NUM> formed to extend in the widthwise direction in the widened portion <NUM>, and which partitions the widened portion <NUM> in a liquid-tight and airtight manner into the first region 20a on the side of the one end and the second region 20b on the side of the other end, the weakly sealed portion <NUM> configured to be opened by increasing the internal pressure of the widened portion <NUM>.

In accordance with the above-described blood bag system <NUM>, since the flow path sealing structure <NUM> is formed integrally with the blood collection bag <NUM> and the like by the resin sheets <NUM> and <NUM>, manufacturing costs can be suppressed.

According to the present embodiment, as shown in <FIG>, a description will be given concerning an example in which the flow path sealing structure <NUM> is applied to a sample collecting structure <NUM> for a bag-shaped container 40A. Moreover, concerning constituent features that are the same as those of the flow path sealing structure <NUM> shown in <FIG> and the bag-shaped container <NUM> shown in <FIG>, they are designated by the same reference numerals, and detailed description of such features is omitted.

The bag-shaped container 40A according to the present embodiment is equipped with the main body portion <NUM> to which a connection port <NUM>, and the sample collecting structure <NUM> are connected to an upper end thereof, and is constituted to be capable of sampling with the sample collecting structure <NUM> a portion of the liquid accommodated in the accommodating section <NUM> of the main body portion <NUM>.

The bag-shaped container 40A is a container of a bag shape in which a pair of resin sheets <NUM> and <NUM> are superimposed on each other and fusion bonded at the peripheral edge sealed portion <NUM>, and is capable of accommodating a liquid in the accommodating section <NUM> via the connection port <NUM> and a tube <NUM> that is connected to the connection port <NUM>.

The sample collecting structure <NUM> includes a sample container <NUM> in which a collected liquid is accommodated, and flow paths <NUM> that connect the sample container <NUM> and the bag-shaped container 40A. The sample container <NUM>, the flow paths <NUM>, and the flow path sealing structure <NUM> that constitute the sample collecting structure <NUM> are formed by the pair of resin sheets <NUM> and <NUM> that constitute the bag-shaped container 40A. More specifically, the sample collecting structure <NUM> is integrally connected to the bag-shaped container 40A.

The flow paths <NUM> are equipped with flow path sealed portions 116a where the pair of resin sheets <NUM> and <NUM> are fusion bonded on both sides thereof, and flow through portions 116b are formed at portions surrounded by the flow path sealed portions 116a. One end of the flow paths <NUM> communicates with the accommodating section <NUM>. Further, another end of the flow paths <NUM> communicates with the interior of the sample container <NUM>. The flow path sealing structure <NUM> is disposed on the way of the flow paths <NUM>, and one end and another end of the flow paths <NUM> are sealed by the flow path sealing structure <NUM>.

The sample container <NUM> is provided with a peripheral edge sealed portion 114a which is formed by fusion bonding the resin sheets <NUM> and <NUM> at a peripheral edge part thereof, and an accommodating section 114b is formed on the inner side of the peripheral edge sealed portion 114a.

Hereinafter, a description will be given concerning a method of using the sample collecting structure <NUM> for the bag-shaped container 40A according to the present embodiment. In the bag-shaped container 40A of the present embodiment, after a liquid which is a contained material has been injected into the accommodating section <NUM> of the main body portion <NUM>, the tube <NUM> is sealed with a sealer and cut.

Thereafter, the accommodating section <NUM> is pressed to apply a pressure to the flow path sealing structure <NUM> through the flow paths <NUM>, thereby opening the flow path sealing structure <NUM>. In addition, the accommodating section <NUM> is further pressed to thereby transfer the liquid accommodated in the accommodating section <NUM> to the sample container <NUM>. Thereafter, the flow path <NUM> is cut while being sealed with a sealer, and as shown in <FIG>, the sample collecting structure <NUM> is separated from the main body portion <NUM>. The sample collecting structure <NUM> is used for testing or analysis.

The above described sample collecting structure <NUM> for the bag-shaped container 40A is manufactured by the following method.

The pair of resin sheets <NUM> and <NUM> which are formed in a predetermined shape are prepared, and after the connection port <NUM> has been temporarily fixed thereto at a predetermined position, the resin sheets <NUM> and <NUM> are superimposed on each other. Thereafter, the first fusion bonding step is performed to thereby form the peripheral edge sealed portions <NUM> and 114a, the flow path sealed portions 116a, and the widened seal portion <NUM>. The first fusion bonding step is performed under a condition in which a strong seal is formed.

Thereafter, the second fusion bonding step is performed to thereby form the weakly sealed portion <NUM> in the flow path sealing structure <NUM>. The second fusion bonding step can be performed by the same method that was described with reference to <FIG>. Thereafter, the tube <NUM> is connected to the connection port <NUM> of the bag-shaped container 40A, whereupon the bag-shaped container 40A is completed. As necessary, the bag-shaped container 40A may be subjected to autoclave sterilization. In this case, it is preferable to attach the opening prevention member <NUM> (see <FIG>) to the weakly sealed portion <NUM> of the flow path sealing structure <NUM>.

The sample collecting structure <NUM> for the bag-shaped container 40A according to the present embodiment exhibits the following advantageous effects.

The sample collecting structure <NUM> for the bag-shaped container 40A includes the flow path <NUM> connected to the bag-shaped container 40A in which the accommodating section <NUM> is formed in the interior thereof, and which are placed in communication with the accommodating section <NUM>, the sample container <NUM> connected to the bag-shaped container 40A via the flow path <NUM>, and the flow path sealing structure <NUM> disposed on the way of the flow path <NUM> and configured to seal the flow path <NUM>, wherein the flow path <NUM>, the sample container <NUM>, and the flow path sealing structure <NUM> are formed integrally with the bag-shaped container 40A by fusion bonding the pair of resin sheets <NUM> and <NUM>. In addition, the flow path sealing structure <NUM> includes the widened portion <NUM> surrounded by the widened seal portion <NUM> formed by fusion bonding together the pair of resin sheets <NUM> and <NUM> around the periphery thereof, and the one end and the other end of which are in communication with the flow path <NUM>, the widened seal portion <NUM> being formed to be wider than the flow path <NUM>, and the weakly sealed portion <NUM> formed to extend in the widthwise direction in the widened portion <NUM>, and which partitions the widened portion <NUM> in a liquid-tight and airtight manner into the first region 20a on the side of the one end and the second region 20b on the side of the other end, the weakly sealed portion <NUM> configured to be opened by increasing the internal pressure of the widened portion <NUM>.

In the sample collecting structure <NUM> of the bag-shaped container 40A according to the present embodiment, since the sample collecting structure <NUM> which includes the flow path sealing structure <NUM> can be simultaneously formed integrally with the pair of resin sheets <NUM> and <NUM> that constitute the bag-shaped container 40A, manufacturing costs can be suppressed.

In the above-described embodiments, an example of the widened portion <NUM> of the flow path sealing structure <NUM> was described as being formed in a circular shape as viewed in plan, however, the embodiments are not limited to this feature. For example, as shown in <FIG>, a widened portion 20A that is formed in a rectangular shape as viewed in plan may also be provided. Such a widened portion 20A is formed in a rectangular shape in which the dimension thereof in the flow path direction extends longer than the dimension in the widthwise direction, and the weakly sealed portion <NUM> extends in the widthwise direction at a central part in the flow path direction. Even if the widened portion 20A of the present embodiment is applied to the flow path sealing structure <NUM>, the same advantages and effects can be obtained.

Claim 1:
A flow path sealing structure (<NUM>), which is disposed on a way of a flow path (<NUM>) formed by fusion bonding a pair of resin sheets (<NUM> and <NUM>) that are superimposed on each other, the flow path sealing structure comprising:
a widened portion (<NUM>) surrounded by a widened seal portion (<NUM>) formed by fusion bonding the pair of resin sheets around a periphery thereof, and one end and another end of which are in communication with the flow path, the widened portion (<NUM>) being formed to be wider than the flow path; and
a weakly sealed portion (<NUM>) configured to be opened by increasing an internal pressure of the widened portion,
characterized in that
the weakly sealed portion (<NUM>) is formed to extend in a widthwise direction in the widened portion, and partitions the widened portion in a liquid-tight and airtight manner into a first region (20a) on a side of the one end and a second region (20b) on a side of the other end.