Collection kit

Abstract

A collection kit (10A) comprises: an inflow tube (12); a plurality of inflow ports (first inflow port (11a) and second inflow port (11b)) which are connected downstream of the inflow tube (12); a collection bag (14A) in which a plurality of accommodation chambers (first accommodation chamber (26) and second accommodation chamber (28)) are formed; a plurality of outflow ports (first outflow port (15) and second outflow port (17)) which are respectively connected to the plurality of accommodation chambers; and a plurality of discharge parts (first discharge part (61) and second discharge part (62)) which are respectively connected to the plurality of accommodation chambers.

Description

Collection kit

[0001] The present invention relates to a collection kit for transferring a collection target (mainly liquid medicines) contained in a medical bag into a plurality of sampling containers.

[0002] Blood products include red blood cell products, plasma products, platelet products, and whole blood products. To ensure safety, small samples of blood products may be collected and cultured. In a culture test, the sample is collected in a culture bottle (sampling container), and the bottle is placed in an environment favorable for bacterial growth to detect the presence or absence of pathogens.

[0003] Below, the procedure for transferring a platelet preparation from a medical bag containing a platelet preparation (hereinafter referred to as a platelet bag) to two culture bottles will be explained using the example of the medical bag.

[0004] A small-capacity collection bag is connected to the platelet bag, and a portion of the platelet product from the platelet bag is transferred to the collection bag. The collection bag is then detached from the platelet bag. Next, in a clean bench, the collection bag is connected to a tube extending from a sample collection tube, and a specified amount of the platelet product is transferred from the collection bag to the sample collection tube using the scale on the sample collection tube as a guide. Two culture bottles are then connected to the sample collection tube in sequence, and the specified amounts of the platelet product are transferred to the two culture bottles. One of the two culture bottles is used for anaerobic culture, and the other is used for aerobic culture.

[0005] For example, US Pat. No. 8,777,921 discloses a collection kit for collecting samples from medical bags.

[0006] U.S. Patent No. 8,777,921

[0007] To further improve the safety of blood products, culture testing of all blood products is being considered. Therefore, there is a need to improve the work efficiency of culture testing of blood products. Furthermore, when performing culture testing of all blood products, it is desirable that the equipment for dividing blood products into culture bottles has a simple structure and is low-cost. It is also desirable that a predetermined amount of the sample can be collected in each of multiple sampling containers.

[0008] The present invention aims to solve the above-mentioned problems.

[0009] (1) One aspect of the present invention is a collection kit for collecting collection objects contained in a medical bag into multiple sampling containers, the collection kit comprising: at least one inlet tube to which the medical bag is connected; multiple inlet ports connected downstream of at least one of the inlet tubes; a collection bag connected downstream of the multiple inlet ports and formed by welding two flexible sheets together, with multiple storage chambers for storing the collection objects formed between the two flexible sheets; multiple outlet ports connected to the multiple storage chambers, respectively, and transporting the collection objects from the multiple storage chambers to the multiple sampling containers; and multiple exhaust sections connected to the multiple storage chambers, respectively, for exhausting air from the multiple storage chambers to the outside of the collection bag, wherein the number of the multiple inlet ports, the number of the multiple storage chambers, and the number of the multiple outlet ports are the same.

[0010] The collection bag has a structure in which two flexible sheets are integrally formed, allowing the collection kit to be manufactured at low cost. The collection bag has multiple storage chambers, each of which can store a predetermined amount (required amount) of the sample to be collected, allowing a predetermined amount of the sample to be collected in each of multiple sampling containers.

[0011] (2) The collection kit described in (1) above may further include a plurality of adapters that are respectively connected downstream of the plurality of outlet ports and are connectable to the plurality of sampling containers.

[0012] With this configuration, the collection kit is initially equipped with multiple adapters, which eliminates the need to connect multiple adapters when using the collection kit, allowing for efficient collection work.

[0013] (3) In the collection kit described in (1) or (2) above, at least one of the inflow tubes may have one common part to which the medical bag is connected and multiple branch parts branching from the common part and respectively connected to multiple of the inflow ports.

[0014] With this configuration, when transferring the sample to be collected from the medical bag to the collection bag, the medical bag and the inlet tube only need to be connected and disconnected once, thereby enabling efficient collection work.

[0015] (4) In the collection kit described in (1) or (2) above, the at least one inflow tube may have a plurality of inflow tubes connected to the plurality of inflow ports, respectively.

[0016] This configuration also makes it possible to transfer the material to be collected from the medical bag to the multiple storage chambers of the collection bag, and to store a predetermined amount of the material to be collected in the multiple storage chambers.

[0017] (5) In the collection kit described in (4) above, the collection bag may include a plurality of segments each having a plurality of the storage chambers, and the plurality of segments may be separable from one another.

[0018] Since the collection bag can be divided into multiple segments, when it is desired to collect the sample objects into fewer sampling containers than the number of storage chambers, it is possible to use only the required number of segments.

[0019] (6) In the collection kit according to any one of (1) to (5) above, at least one of the inflow tubes may be disposed outside the collection bag.

[0020] According to the collection kit of the present invention, the collection bag has a structure in which it is integrally formed using two flexible sheets, so that the collection kit can be manufactured at low cost. The collection bag has multiple storage chambers, and each of the multiple storage chambers can store a predetermined amount (required amount) of the sample to be collected, so that a predetermined amount of the sample to be collected can be collected into each of multiple sampling containers.

[0021] FIG. 1 is an overall view of a collection kit according to a first embodiment of the present invention. FIG. 2 is a view showing a state in which a collection target has been collected in the collection kit according to the first embodiment of the present invention. FIG. 3 is a view showing a state in which the collection kit according to the first embodiment of the present invention is connected to a culture bottle. FIG. 4 is an overall view of a collection kit according to a second embodiment of the present invention. FIG. 5 is a view showing a state in which a collection target has been collected in a first storage chamber of the collection kit according to the second embodiment of the present invention. FIG. 6 is a view showing a state in which a collection target has been collected in a first storage chamber and a second storage chamber of the collection kit according to the second embodiment of the present invention. FIG. 7 is a view showing a state in which the collection kit according to the second embodiment of the present invention is connected to a culture bottle. FIG. 8 is a view explaining another method of using the collection kit according to the second embodiment of the present invention.

[0022] The collection kit 10A according to this embodiment, shown in FIGS. 1 to 3, is used to transfer a blood product to be collected to sampling containers 51 and 52 (see FIG. 3). The collection target may be, for example, a blood product such as a platelet product. The collection target may also be a pharmaceutical product other than a blood product. The collection target may also be a liquid sample other than a pharmaceutical product. The medical bag 56 (FIG. 2) may be a blood bag system for centrifuging blood containing multiple components into multiple components with different specific gravities (e.g., three components: a light component, a medium component, and a heavy component, or two components: a light component and a heavy component), and storing and storing each component in a separate bag. In this case, the collection kit 10A may be connected to the blood bag system. The collection kit 10A is typically used in a position where the up-down direction in FIGS. 1 to 3 is aligned vertically. For this reason, in the following description, for collection kit 10A, the up-down direction (V direction) in Figures 1 to 3 will also be referred to as the "up-down direction," and the left-right direction (W direction) in Figures 1 to 3 will also be referred to as the "width direction." The definitions of the above directions also apply to collection kit 10B (Figures 4 to 7), which will be described later.

[0023] The collection kit 10A is used, for example, in a culture test to confirm the safety of blood products at a business establishment such as a blood center that produces blood products. In this case, the sampling containers 51 and 52 shown in Figure 3 are culture bottles.

[0024] The culture test involves testing the culture of anaerobic bacteria and the culture of aerobic bacteria. Therefore, two bottles are used for the culture test: a sampling container 51 for anaerobic culture (hereinafter also referred to as the "first sampling container 51") and a sampling container 52 for aerobic culture (hereinafter also referred to as the "second sampling container 52"). The collection kit 10A is used to collect a liquid sample (platelet product) and dispense a predetermined amount into the two sampling containers 51 and 52.

[0025] In the following, in this embodiment, an example will be described in which a platelet product is used as the blood product, but the blood product collected by collection kit 10A may be a red blood cell product, a plasma product, or a whole blood product.

[0026] 1, collection kit 10A includes inlet tube 12, a plurality of inlet ports (first inlet port 11a and second inlet port 11b), collection bag 14A, a plurality of outlet ports (first outlet port 15 and second outlet port 17), and a plurality of adapters (first adapter 21a and second adapter 21b). Collection kit 10A further includes a plurality of exhaust units (first exhaust unit 61 and second exhaust unit 62).

[0027] The inflow tube 12 is a translucent medical tube made of a thermoplastic resin such as polyvinyl chloride. The inflow tube 12 can be connected to or disconnected from other medical tubes without exposing the interior to the outside air, using, for example, a sterile connection device or a tube sealer. The inflow tube 12 has an upstream end 12a and multiple downstream ends 12b. The upstream end 12a of the inflow tube 12 is initially welded and sealed. In the first embodiment, the inflow tube 12 has two downstream ends 12b. The inflow tube 12 has one common portion 120 to which the medical bag 56 (see FIG. 2) is connected and multiple branch portions (first branch portion 121 and second branch portion 122) branching from the common portion 120. The inflow tube 12 is not present within the collection bag 14A. That is, the inflow tube 12 is not formed between the flexible sheets 22a and 22b and is disposed outside the collection bag 14A.

[0028] The first inflow port 11a and the second inflow port 11b are inlet ports for introducing the collection target into the collection bag 14A from the inflow tube 12. The first inflow port 11a and the second inflow port 11b protrude upward from the upper side 141 of the collection bag 14A. The downstream end 12b of the first branch portion 121 is connected to the first inflow port 11a. The downstream end 12b of the second branch portion 122 is connected to the second inflow port 11b.

[0029] The collection bag 14A has two flexible sheets 22a, 22b stacked in the thickness direction. The two flexible sheets 22a, 22b are welded and joined to each other at multiple welds. The sheet portion 22 consisting of the two flexible sheets 22a, 22b is rectangular. The collection bag 14A includes multiple inlet flow paths (first inlet flow path 31 and second inlet flow path 32), multiple storage chambers (first storage chamber 26 and second storage chamber 28), and multiple outlet flow paths (first outlet flow path 34 and second outlet flow path 36). The multiple inlet flow paths, multiple storage chambers, and multiple outlet flow paths are defined by the welds.

[0030] The collection bag 14A may have three or more inlet channels, three or more storage chambers, and three or more outlet channels. The number of inlet channels, the number of storage chambers, and the number of outlet channels are the same. Because the multiple inlet channels and the multiple branch portions correspond to each other (one branch portion is provided for each inlet channel), when the collection bag 14A has three or more inlet channels, the number of branch portions of the inlet tube 12 is the same as the number of inlet channels.

[0031] In the initial state of the collection kit 10A, the first inflow flow path 31, the second inflow flow path 32, the first storage chamber 26, the second storage chamber 28, the first outflow flow path 34, and the second outflow flow path 36 bulge in the thickness direction of the collection bag 14A. Therefore, the two flexible sheets 22a, 22b are spaced apart in the thickness direction at the first inflow flow path 31, the second inflow flow path 32, the first storage chamber 26, the second storage chamber 28, the first outflow flow path 34, and the second outflow flow path 36. The thickness direction of the collection bag 14A is perpendicular to the up-down direction (V direction) and the width direction (W direction).

[0032] The first inlet flow path 31 connects the first inlet port 11a and the first storage chamber 26 of the collection bag 14A. The first inlet flow path 31 is connected to the upper end of the first storage chamber 26 of the collection bag 14A. The second inlet flow path 32 connects the second inlet port 11b and the second storage chamber 28 of the collection bag 14A. The second inlet flow path 32 is connected to the upper end of the second storage chamber 28 of the collection bag 14A. As shown by the phantom lines in FIG. 1 , the first inlet flow path 31 may be connected to the lower portion 262 of the first storage chamber 26, and the second inlet flow path 32 may be connected to the lower portion 282 of the second storage chamber 28.

[0033] The first storage chamber 26 is a storage area that temporarily stores the platelet preparation before transferring the platelet preparation to the first sampling container 51. In the initial state of the collection kit 10A, the first storage chamber 26 bulges in the thickness direction of the collection bag 14A, and air is present within the first storage chamber 26. The first storage chamber 26 has a capacity that can store a predetermined amount (e.g., approximately 8 mL to approximately 10 mL) of the platelet preparation.

[0034] The upper portion 261 of the first storage chamber 26 has a generally triangular shape whose width gradually decreases toward the top. The first inlet flow path 31 is connected to the upper end of the upper portion 261. The lower portion 262 of the first storage chamber 26 also has a generally triangular shape whose width gradually decreases toward the bottom. The middle portion 263 of the first storage chamber 26 is located between the upper portion 261 and the lower portion 262, and has a constant width in the vertical direction.

[0035] The first outflow flow path 34 is connected to the lower end (the lower end of the lower portion 262) of the first storage chamber 26. The first outflow flow path 34 extends downward from the lower end of the first storage chamber 26. The first outflow flow path 34 is a flow path for transporting the sample to be collected toward the first sampling container 51.

[0036] The second storage chamber 28 is a storage area that temporarily stores the platelet preparation before transferring the platelet preparation to the second sampling container 52. In the initial state of the collection kit 10A, the second storage chamber 28 bulges in the thickness direction of the collection bag 14A, and air is present within the second storage chamber 28. The second storage chamber 28 has the same shape as the first storage chamber 26 and has a volume that can store the same amount of platelet preparation (e.g., approximately 8 mL to approximately 10 mL) as the first storage chamber 26. The volumes of the first storage chamber 26 and the second storage chamber 28 may be different from each other.

[0037] The upper portion 281 of the second storage chamber 28 has a generally triangular shape whose width gradually decreases toward the top. The lower portion 282 of the second storage chamber 28 also has a generally triangular shape whose width gradually decreases toward the bottom. The middle portion 283 of the second storage chamber 28 is located between the upper portion 281 and the lower portion 282, and has a constant width in the vertical direction.

[0038] The second outlet flow path 36 is connected to the lower end of the second storage chamber 28. The second outlet flow path 36 extends downward from the lower end of the second storage chamber 28. The second outlet flow path 36 is a flow path for transporting the sample to the second sampling container 52.

[0039] The first exhaust unit 61 exhausts air from the first storage chamber 26 to the outside of the collection bag 14A when the collection object flows into the first storage chamber 26. The collection bag 14A has a first exhaust flow path 41 connected to an upper portion 261 of the first storage chamber 26. The first exhaust flow path 41 is formed between the flexible sheets 22a and 22b. The first exhaust unit 61 is connected to the first exhaust flow path 41. The first exhaust unit 61 has a filter 64.

[0040] The filter 64 has the function of allowing gas to pass through and preventing liquid from passing through. In the first embodiment, the filter 64 is a hydrophilic filter 64a. The hydrophilic filter 64a allows gas to pass through before it is wet with liquid, and prevents gas from passing through after it is wet with liquid. When the hydrophilic filter 64a comes into contact with the sample as the first storage chamber 26 is filled with the sample, the pores of the hydrophilic filter 64a are blocked by the liquid that constitutes the sample, and thereafter the first exhaust section 61 prevents gas and liquid from passing through.

[0041] The second exhaust unit 62 exhausts air from the second storage chamber 28 to the outside of the collection bag 14A when the collection subject flows into the second storage chamber 28. The collection bag 14A has a second exhaust flow path 42 connected to the upper part 281 of the second storage chamber 28. The second exhaust flow path 42 is formed between the flexible sheets 22a, 22b. A second exhaust unit 62 is connected to the second exhaust flow path 42. The second exhaust unit 62 has a filter 64 (hydrophilic filter 64a).

[0042] Note that, since the multiple storage chambers and the multiple exhaust sections correspond to one another (because one exhaust section is provided for each storage chamber), when collection bag 14A has three or more storage chambers, the number of exhaust sections is the same as the number of storage chambers. As another aspect of first exhaust section 61, a filter 64 may be disposed in a wall section forming first storage chamber 26. As another aspect of second exhaust section 62, a filter 64 may be disposed in a wall section forming second storage chamber 28.

[0043] 1, the first outlet port 15 is connected to the first outlet flow path 34. The first outlet port 15 is a flow path member for transferring the collection object from the first storage chamber 26 toward the first sampling container 51 (see FIG. 3). The first outlet port 15 is connected to the first adapter 21a. The first outlet port 15 protrudes from the bottom edge 142 of the collection bag 14A.

[0044] The first outflow port 15 functions as a first sealing member 16. In the initial state, the first sealing member 16 seals the first outflow flow path 34 and prevents fluid from passing between the first storage chamber 26 and the first adapter 21a. The first sealing member 16 is a cylindrical member having a breakable plug therein, and in the initial state, when the plug is bent, the plug breaks, opening the internal flow path.

[0045] The second outlet port 17 is connected to the second outlet flow path 36. The second outlet port 17 is a flow path member for transferring the collection object from the second storage chamber 28 toward the second sampling container 52 (see FIG. 3). The second outlet port 17 is connected to the second adapter 21b. The second outlet port 17 protrudes from the bottom side 142 of the collection bag 14A.

[0046] The second outflow port 17 functions as a second sealing member 18. The second sealing member 18 is a member similar to the first sealing member 16, and in the initial state, seals the second outflow flow path 36 to prevent the passage of fluid between the second storage chamber 28 and the second adapter 21b.

[0047] The first adapter 21a has a housing tube 80 capable of housing the neck of the first sampling container 51, a tubular needle portion 82 disposed inside the housing tube 80, and a rubber cover 84 that covers the needle portion 82. The housing tube 80 has an openable and closable lid 86. A release sheet may be used instead of the lid 86.

[0048] The needle 82 can be inserted into the rubber stopper 93 (see FIG. 3 ) of the first sampling container 51. When the needle 82 of the first adapter 21a penetrates the rubber stopper 93 of the first sampling container 51 and the first sealing member 16 opens, the first sampling container 51 and the first storage chamber 26 communicate with each other. When the needle 82 penetrates the rubber stopper 93 of the first sampling container 51, the rubber cover 84 is pushed toward the base end, causing the needle 82 to penetrate the rubber cover 84. When the needle 82 is removed from the rubber stopper 93 of the first sampling container 51, the rubber cover 84 stretches due to its elastic restoring force, covering the needle 82 again.

[0049] The second adapter 21b has a configuration similar to that of the first adapter 21a. When the needle 82 of the second adapter 21b penetrates the rubber stopper 93 of the second sampling container 52 and the second sealing member 18 opens, the second sampling container 52 and the second storage chamber 28 communicate with each other.

[0050] If the collection bag 14A has three or more storage chambers, the collection kit 10A has three or more outlet ports and three or more adapters corresponding to the respective storage chambers.

[0051] In the initial state of the collection kit 10A, the first adapter 21a and the second adapter 21b may not be provided in the collection kit 10A. In this case, when the collection kit 10A is used, the first adapter 21a and the second adapter 21b are connected to the collection kit 10A. For example, the first adapter 21a has an engaging claw and a connecting needle, and the lower part of the first outflow port 15 has an engaging groove and a rubber stopper. The first adapter 21a and the first outflow port 15 are connected by inserting the connecting needle into the rubber stopper and engaging the engaging claw with the engaging groove. The second adapter 21b has a connection structure similar to that of the first adapter 21a.

[0052] The collection kit 10A configured as described above is used as follows: In the first embodiment, a collection method will be described in which the collection object is a platelet preparation and the platelet preparation is dispensed into two sampling containers 51, 52 (see FIG. 3 ) using the collection kit 10A.

[0053] As shown in Figure 2, a platelet bag 57, which is one form of a medical bag 56 containing a collection target, is attached to the collection kit 10A. The platelet bag 57 has a connecting tube 58. The tube 58 is attached to the inflow tube 12. The tube 58 is attached to the inflow tube 12 using a sterile attachment device without coming into contact with the outside air.

[0054] Next, the platelet preparation is introduced into the collection bag 14A. In this step, the platelet bag 57 is positioned above the collection bag 14A. The first sealing member 16 and the second sealing member 18 of the collection kit 10A are maintained in a closed state.

[0055] The platelet preparation flows out of the platelet bag 57 due to gravity and flows into the common portion 120 of the inflow tube 12. The platelet preparation is divided into a first branch portion 121 and a second branch portion 122 at the downstream end of the common portion 120 and flows into the collection bag 14A. Therefore, the platelet preparation that has passed through the first branch portion 121 flows into the collection bag 14A via the first inflow port 11a, and the platelet preparation that has passed through the second branch portion 122 flows into the collection bag 14A via the second inflow port 11b.

[0056] The platelet preparation that has flowed into the collection bag 14A via the first inflow port 11a flows into the first storage chamber 26 via the first inflow flow path 31. The platelet preparation is stored in the first storage chamber 26, and the liquid level of the platelet preparation in the first storage chamber 26 rises. The air inside the first storage chamber 26 is pushed up by the platelet preparation and is discharged from the first exhaust section 61 via the first exhaust flow path 41.

[0057] When the first storage chamber 26 is filled with the platelet preparation and the filter 64 of the first exhaust unit 61 comes into contact with the platelet preparation and becomes wet, the filter 64 closes, stopping the inflow of the platelet preparation into the first storage chamber 26. This completes the introduction of the platelet preparation into the first storage chamber 26. A predetermined amount (e.g., approximately 8 mL to 10 mL) of the platelet preparation is stored in the first storage chamber 26.

[0058] Meanwhile, the platelet preparation that has flowed into the collection bag 14A via the second inflow port 11b flows into the second storage chamber 28 via the second inflow flow path 32. The platelet preparation is stored in the second storage chamber 28, and the liquid level of the platelet preparation in the second storage chamber 28 rises. The air inside the second storage chamber 28 is pushed up by the platelet preparation and is discharged from the second exhaust section 62 via the second exhaust flow path 42.

[0059] When the second storage chamber 28 is filled with the platelet preparation and the filter 64 of the second exhaust unit 62 comes into contact with the platelet preparation and becomes wet, the filter 64 closes, stopping the inflow of the platelet preparation into the second storage chamber 28. This completes the introduction of the platelet preparation into the second storage chamber 28. A predetermined amount (e.g., approximately 8 mL to 10 mL) of the platelet preparation is stored in the second storage chamber 28.

[0060] The platelet bag 57 is then separated from the inflow tube 12 using a tube sealer (high-frequency sealer or ultrasonic sealer) or the like. The tube sealer separates the inflow tube 12 from the tube 58 of the platelet bag 57 and simultaneously seals the upstream end 12a of the inflow tube 12 by welding. The separation of the inflow tube 12 and the tube 58 is performed without exposing the internal flow path to the outside air. The separated platelet bag 57 is stored until the culture test is completed, and then is ready for use.

[0061] Meanwhile, the collection kit 10A filled with the platelet product is carried into a clean bench. Next, as shown in Figure 3, operations (connecting step and opening step) are performed to transfer the platelet product from the collection kit 10A to the first sampling container 51 and the second sampling container 52.

[0062] In the connecting step, the first sampling container 51 is connected to the first adapter 21a, and the second sampling container 52 is connected to the second adapter 21b. The needle 82 of the first adapter 21a pierces the rubber stopper 93 of the first sampling container 51, and the needle 82 of the second adapter 21b pierces the rubber stopper 93 of the second sampling container 52.

[0063] Thereafter, when the first sealing member 16 is opened in the opening step, the platelet product in the first storage chamber 26 is sucked by the negative pressure in the first sampling container 51 and flows into the first sampling container 51 via the first outflow flow path 34 and the first outflow port 15 (first sealing member 16). This allows a predetermined amount of platelet product to be introduced into the first sampling container 51. Furthermore, when the second sealing member 18 is opened in the opening step, the platelet product in the second storage chamber 28 is sucked by the negative pressure in the second sampling container 52 and flows into the second sampling container 52 via the second outflow flow path 36 and the second outflow port 17 (second sealing member 18). This allows a predetermined amount of platelet product to be introduced into the second sampling container 52.

[0064] As a result, almost the entire amount of platelet preparation stored in the first storage chamber 26 is transferred to the first sampling container 51, and almost the entire amount of platelet preparation stored in the second storage chamber 28 is transferred to the second sampling container 52.

[0065] The above steps complete collection of the collection target (platelet preparation) using collection kit 10A.

[0066] When collecting a collection target using the collection kit 10A, a jig (collection kit jig) may be used to connect the collection kit 10A to the first sampling container 51 and the second sampling container 52. The collection kit jig may include, for example, a kit holder that holds the collection kit 10A, an elevating mechanism that displaces the kit holder up and down, and a bottle holder that holds the first sampling container 51 and the second sampling container 52. The collection kit 10A can be connected to the first sampling container 51 and the second sampling container 52 by lowering the kit holder that holds the collection kit 10A. Instead of the elevating mechanism that displaces the kit holder up and down, a lifting mechanism that raises and lowers the bottle holder may be provided.

[0067] The first embodiment has the following advantages.

[0068] The collection kit 10A has a structure in which the collection bag 14A is integrally formed using two flexible sheets 22a, 22b, making it possible to manufacture it at low cost. Furthermore, the number of times that the tubes need to be joined and separated can be minimized, resulting in excellent work efficiency. Furthermore, since the work of measuring the sample by eye by aligning it with the scale line is no longer necessary, the work is simplified and measurement errors are reduced.

[0069] The collection bag 14A has a first storage chamber 26 and a second storage chamber 28, and can store a predetermined amount (required amount) of the material to be collected in the first storage chamber 26 and the second storage chamber 28, so that a predetermined amount of the material to be collected can be collected in each of the first sampling container 51 and the second sampling container 52. Therefore, the collection kit 10A can reduce variation in the amount of material to be collected introduced into the first sampling container 51 and the second sampling container 52.

[0070] In the collection kit 10A, the number of inlet ports, the number of storage chambers, and the number of outlet ports are the same. Specifically, in the first embodiment, the collection kit 10A includes two inlet ports (first inlet port 11a and second inlet port 11b), two storage chambers (first storage chamber 26 and second storage chamber 28), and two outlet ports (first outlet port 15 and second outlet port 17). With this configuration, a connecting flow path connecting the first storage chamber 26 and the second storage chamber 28 is not formed in the collection bag 14A, thereby avoiding a complex configuration of the collection bag 14A. Furthermore, if the connecting flow path were formed, a step of blocking the connecting flow path (blocking step) would be required to prevent movement of the collection target between the first storage chamber 26 and the second storage chamber 28. In contrast, the collection kit 10A has the first storage chamber 26 and the second storage chamber 28 that are independent of each other, eliminating the need for the blocking step described above.

[0071] Since the collection kit 10A is initially equipped with multiple adapters (first adapter 21a and second adapter 21b), the hassle of connecting multiple adapters when using the collection kit 10A can be eliminated, allowing collection work to be performed efficiently.

[0072] The inflow tube 12 has one common section 120 to which the medical bag 56 is connected, and multiple branch sections (a first branch section 121 and a second branch section 122) that branch off from the common section 120 and are connected to multiple inflow ports, respectively. With this configuration, when transferring the collection target from the medical bag 56 to the collection bag 14A, the medical bag 56 and the inflow tube 12 only need to be connected and disconnected once, allowing for efficient collection work.

[0073] Next, a collection kit 10B according to a second embodiment will be described with reference to FIGS.

[0074] The collection kit 10B according to the second embodiment includes multiple inlet tubes connected to multiple inlet ports, respectively. Because the number of inlet tubes in the second embodiment is two, they will be referred to as the "first inlet tube 91" and the "second inlet tube 92," respectively. The upstream end 91a of the first inlet tube 91 is initially welded and sealed. The downstream end 91b of the first inlet tube 91 is connected to the first inlet port 11a. The upstream end 92a of the second inlet tube 92 is initially welded and sealed. The downstream end 92b of the second inlet tube 92 is connected to the second inlet port 11b.

[0075] Collection bag 14B of collection kit 10B differs from collection bag 14A shown in Figure 1 in that it includes a frangible portion 66 and multiple segments separated by frangible portion 66. Because collection bag 14B shown in Figure 4 has two segments, these will be referred to below as "first segment S1" and "second segment S2." First segment S1 includes first storage chamber 26. Second segment S2 includes second storage chamber 28.

[0076] The fragile portion 66 extends vertically from the upper edge 141 to the lower edge 142 of the collection bag 14B. Therefore, the fragile portion 66 divides the collection bag 14B into left and right regions. The fragile portion 66 is a structural portion that enables the first segment S1 and the second segment S2 to be separated from each other. The fragile portion 66 is a portion that is weaker in strength than other structural portions of the collection bag 14B and is more likely to break. In the second embodiment, the fragile portion 66 is a perforation 67. The fragile portion 66 may also be a thin-walled portion.

[0077] The collection kit 10B configured as described above is used as follows: In the second embodiment, a collection method will be described in which the collection object is a platelet preparation and the platelet preparation is dispensed into two sampling containers 51, 52 (see FIG. 7 ) using the collection kit 10B.

[0078] 5, tubing 58 of platelet bag 57 is joined to first inlet tubing 91 of collection kit 10B. Tubing 58 is joined to first inlet tubing 91 using a sterile joining device without contacting the outside air.

[0079] Next, the platelet preparation is introduced into the first storage chamber 26 of the collection bag 14B. In this step, the platelet bag 57 is positioned above the collection bag 14B. The first sealing member 16 of the collection kit 10B is maintained in a closed state.

[0080] The platelet preparation flows out of the platelet bag 57 by gravity, flows into the first inlet flow path 31 via the first inlet tube 91 and the first inlet port 11a, and then flows into the first storage chamber 26. Thereafter, as in the collection method described with reference to FIG. 2 , air is discharged from the first storage chamber 26 via the first exhaust part 61, and the first storage chamber 26 is filled with the platelet preparation.

[0081] Thereafter, the platelet bag 57 is separated from the first inlet tube 91 by a tube sealer (high frequency sealer or ultrasonic sealer) or the like.

[0082] 6, the tubing 58 of the platelet bag 57 is joined to the second inlet tubing 92. The tubing 58 is joined to the second inlet tubing 92 using a sterile joining device without contacting the tubing with the outside air.

[0083] Next, the platelet preparation is introduced into the second storage chamber 28 of the collection bag 14B. In this step, the platelet bag 57 is positioned above the collection bag 14B. The second sealing member 18 of the collection kit 10B is maintained in a closed state.

[0084] The platelet preparation flows out of the platelet bag 57 by gravity, flows into the second inlet flow path 32 via the second inlet tube 92 and the second inlet port 11b, and then flows into the second storage chamber 28. Thereafter, as in the collection method described with reference to Fig. 2, air is discharged from the second storage chamber 28 via the second exhaust section 62, and the second storage chamber 28 is filled with the platelet preparation.

[0085] Thereafter, the platelet bag 57 is separated from the second inlet tube 92 using a tube sealer (high-frequency sealer or ultrasonic sealer) or the like. The separated platelet bag 57 is stored until the culture test is completed, and then is put to use. Note that the above-described procedure may be reversed, where the step of introducing the platelet preparation into the second storage chamber 28 is performed first, and then the step of introducing the platelet preparation into the first storage chamber 26 is performed.

[0086] Meanwhile, the collection kit 10B filled with the platelet product is carried into a clean bench. Next, as shown in Figure 7, operations (connecting step and opening step) are performed to transfer the platelet product from the collection kit 10B to the first sampling container 51 and the second sampling container 52. The connecting step and opening step are the same as the connecting step and opening step described with reference to Figure 3.

[0087] Through the above steps, collection of a platelet preparation using collection kit 10B is completed.

[0088] When collecting a platelet preparation using the collection kit 10B, a jig (collection kit jig) for connecting the collection kit 10B to the first sampling container 51 and the second sampling container 52 may be used.

[0089] The collection kit 10B according to the second embodiment has the following advantages.

[0090] The collection kit 10B has a plurality of inlet tubes (first inlet tube 91 and second inlet tube 92) connected to a plurality of inlet ports (first inlet port 11a and second inlet port 11b), respectively. This configuration also makes it possible to transfer the material to be collected from the medical bag 56 to a plurality of storage chambers of the collection bag 14B and store a predetermined amount of the material to be collected in the plurality of storage chambers.

[0091] The collection bag 14B includes multiple segments (first segment S1 and second segment S2), each having multiple storage chambers. The multiple segments are detachable from one another. This configuration allows the collection bag 14B to be divided into multiple segments. When it is desired to collect samples into fewer sampling containers than the number of storage chambers, only the necessary number of segments can be used. For example, if samples are collected into two sampling containers and another sample is needed for an additional culture test, the first segment S1 can be separated from the second segment S2, as shown in FIG. 8, and then the samples can be collected using only the first segment S1.

[0092] 7, the first segment S1 may be separated from the second segment S2 after the collection target is collected into the collection bag 14B. In this case, the collection target is collected into the first segment S1 of the collection bag 14B before the first and second segments S1 and S2 are separated from each other. Next, the first segment S1 is separated from the second segment S2. Next, a sampling container is connected to the adapter (first adapter 21a) connected to the first segment S1, and the collection target is transferred to the sampling container.

[0093] In the second embodiment, the parts common to the first embodiment provide the same or similar functions and effects as the first embodiment.

[0094] The present invention is not limited to the above disclosure, and various configurations can be adopted without departing from the gist of the present invention.

Claims

1. A collection kit for collecting samples contained in a medical bag into a plurality of sampling containers, comprising: at least one inflow tube to which the medical bag is connected; a plurality of inflow ports connected downstream of the at least one inflow tube; a collection bag connected downstream of the plurality of inflow ports and formed by overlapping and welding two flexible sheets, with a plurality of storage chambers for storing the samples formed between the two flexible sheets; a plurality of outflow ports connected respectively to the plurality of storage chambers and transporting the samples from the plurality of storage chambers to the plurality of sampling containers; and a plurality of exhaust sections connected respectively to the plurality of storage chambers and for discharging air inside the plurality of storage chambers to the outside of the collection bag, wherein the number of the plurality of inflow ports, the number of the plurality of storage chambers, and the number of the plurality of outflow ports are all the same.

2. A collection kit according to claim 1, comprising a plurality of adapters respectively connected downstream of a plurality of said outlet ports and connectable to a plurality of said sampling containers.

3. A collection kit according to claim 1 or 2, wherein at least one of the inflow tubes has a common section to which the medical bag is connected, and a plurality of branch sections branching off from the common section and respectively connected to a plurality of the inflow ports.

4. A collection kit according to claim 1 or 2, wherein at least one of said inflow tubes comprises a plurality of inflow tubes respectively connected to a plurality of said inflow ports.

5. A collection kit according to claim 4, wherein the collection bag comprises a plurality of segments each having a plurality of the storage chambers, and the plurality of segments are separable from one another.

6. A collection kit according to claim 1 or 2, wherein at least one of the inflow tubes is disposed outside the collection bag.

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