Collection kit

Abstract

A collection kit (10A) comprises an inflow tube (12) and a collection bag (14A). The collection bag (14A) has a plurality of accommodation chambers (first accommodation chamber (26) and second accommodation chamber (28)), a connection flow path (30) that connects the plurality of accommodation chambers to each other, an exhaust part (40) that is disposed in a wall part (48) forming at least one of the plurality of accommodation chambers, and a plurality of outflow ports (first outflow port (15) and second outflow port (17)) that 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, comprising: an inlet tube to which the medical bag is connected; and a collection bag connected downstream of the inlet tube and formed by welding two flexible sheets together. The collection bag has multiple storage chambers for storing the collection objects, connecting flow paths connecting the multiple storage chambers, an exhaust section disposed in a wall portion forming at least one of the multiple storage chambers for discharging air inside the multiple storage chambers to the outside of the collection bag, and multiple outlet ports connected respectively to the multiple storage chambers and for transporting the collection objects from the multiple storage chambers to the multiple sampling containers.

[0010] Because the collection bag is integrally formed using two flexible sheets, the collection kit can be manufactured at low cost. The collection bag has multiple storage chambers, and since each of the multiple storage chambers can store a predetermined amount (required amount), a predetermined amount of the sample to be collected can be collected in each of multiple sampling containers. Because an exhaust section is provided in the wall portion forming the collection bag, the structure of the collection kit can be simplified compared to a configuration in which an exhaust section is provided in a tube protruding from the collection bag.

[0011] (2) In the collection kit described in (1) above, the collection bag has a first end to which the inlet tube is connected and a second end opposite the first end on which a plurality of the outlet ports are provided, the collection kit is configured to be used in a position in which the second end is lower than the first end, and the exhaust section may be located at the top of the wall section.

[0012] With this configuration, the material to be collected is stored in the storage chamber from the bottom up, and by providing an exhaust section at the top of the wall that forms the storage chamber, air can be efficiently exhausted from inside the storage chamber.

[0013] (3) In the collection kit described in (1) or (2) above, the exhaust section may have a hydrophilic filter.

[0014] The hydrophilic filter allows gas to pass through before it is wetted with liquid, but prevents the passage of gas and liquid after it is wetted with liquid, making it suitable as a member for discharging air from the storage chamber.

[0015] (4) The collection kit described in any one of (1) to (3) above may include a plurality of adapters that are respectively connected downstream of the plurality of outlet ports and that can be connected to a plurality of the sampling containers.

[0016] Since the collection kit is initially equipped with multiple adapters, the effort of connecting multiple adapters when using the collection kit can be eliminated, allowing collection work to be performed efficiently.

[0017] (5) In the collection kit described in any one of (1) to (4) above, the plurality of storage chambers may have a first storage chamber and a second storage chamber, the collection bag may have an inlet flow path connecting the inlet tube and the first storage chamber, the upstream end of the connecting flow path may be connected to the first storage chamber, and the downstream end of the connecting flow path may be connected to the second storage chamber, and the exhaust section may be provided in a wall portion forming the second storage chamber.

[0018] With this configuration, the air inside the first storage chamber moves to the second storage chamber via the connecting flow path and is exhausted from the exhaust section, so the exhaust section only needs to be placed in the second storage chamber out of the first and second storage chambers.

[0019] (6) In the collection kit described in any one of (1) to (4) above, the plurality of storage chambers may include a first storage chamber and a second storage chamber, the collection bag may have a common flow path connected downstream of the inlet tube, the connecting flow path may include a first branch path branching from the common flow path and communicating with the first storage chamber, and a second branch path branching from the common flow path and communicating with the second storage chamber, and the exhaust section may include a first exhaust section arranged in a wall portion forming the first storage chamber, and a second exhaust section arranged in a wall portion forming the second storage chamber.

[0020] With this configuration, the material to be collected flows into the first storage chamber and the second storage chamber via the first branch path and the second branch path, respectively, and the air inside the first storage chamber and the second storage chamber is exhausted from the first exhaust section and the second exhaust section, respectively, so that air can be efficiently exhausted from inside the first storage chamber and the second storage chamber.

[0021] According to the collection kit of the present invention, the collection bag is integrally formed using two flexible sheets, allowing the collection kit to 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), allowing a predetermined amount of the sample to be collected in each of multiple sampling containers. Because an exhaust section is provided in the wall portion forming the collection bag, the structure of the collection kit can be simplified compared to a configuration in which an exhaust section is provided in a tube protruding from the collection bag.

[0022] FIG. 1 is an overall view of a collection kit according to a first embodiment of the present invention. FIG. 2 is an explanatory diagram of the structure of an exhaust unit. FIG. 3 is a view of the collection kit according to the first embodiment of the present invention in a state where a collection target has been collected. FIG. 4 is a view of the collection kit according to the first embodiment of the present invention in a state where it is connected to a culture bottle. FIG. 5 is an overall view of a collection kit according to a second embodiment of the present invention. FIG. 6 is a view of the collection kit according to the second embodiment of the present invention in a state where a collection target has been collected. FIG. 7 is a view of the collection kit according to the second embodiment of the present invention in a state where it is connected to a culture bottle.

[0023] The collection kit 10A according to this embodiment, shown in FIGS. 1, 3, and 4, is used to transfer a blood product to be collected to sampling containers 51 and 52 (see FIG. 4). 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. 3) 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, 3, and 4 is aligned vertically. Therefore, in the following description, for the collection kit 10A, the vertical direction (V direction) in Figures 1, 3, and 4 will also be referred to as the "vertical direction," and the left-right direction (W direction) in Figures 1, 3, and 4 will also be referred to as the "width direction."

[0024] The collection kit 10A is used, for example, in culture tests 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 are culture bottles.

[0025] 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.

[0026] 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.

[0027] The collection kit 10A includes an inflow tube 12, an inflow port 11, a collection bag 14A, a plurality of outflow ports (a first outflow port 15 and a second outflow port 17), and a plurality of adapters (a first adapter 21a and a second adapter 21b).

[0028] 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 using, for example, a sterile connection device or a tube sealer without exposing the interior to the outside air. The inflow tube 12 has a first end 12a on the upstream side and a second end 12b on the downstream side. The first end 12a is initially welded and sealed. The second end 12b is connected to the upper end of the collection bag 14A via the inflow port 11.

[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 collection bag 14A includes an inlet channel 32, multiple storage chambers, a connecting channel 30, and multiple outlet channels. The inlet channel 32, the multiple storage chambers, the connecting channel 30, and the multiple outlet channels are defined by the welds. The multiple storage chambers include a first storage chamber 26 and a second storage chamber 28. The multiple outlet channels include a first outlet channel 34 and a second outlet channel 36. The collection bag 14A may have three or more storage chambers and three or more outlet channels.

[0030] In the initial state of the collection kit 10A, the inflow passage 32, the first storage chamber 26, the second storage chamber 28, the connecting passage 30, the first outflow passage 34, and the second outflow passage 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 inflow passage 32, the first storage chamber 26, the second storage chamber 28, the connecting passage 30, the first outflow passage 34, and the second outflow passage 36. The thickness direction of the collection bag 14A is perpendicular to the up-down direction (V direction) and the width direction (W direction).

[0031] The sheet part 22, which is made up of two flexible sheets 22a and 22b, has a first region 221 for forming the first storage chamber 26, a second region 222 for forming the second storage chamber 28, and a connecting region 223 that connects the first region 221 and the second region 222. When viewed in the thickness direction of the collection bag 14A, the first region 221 has a rectangular shape with the same dimensions as the second region 222.

[0032] The connecting region 223 extends in the width direction and integrally connects the first region 221 and the second region 222. The sheet portion 22 has a pair of cutouts 224 formed by cutting out rectangular shapes in the sheet portion 22 above and below the connecting region 223. The connecting region 223 is formed between the upper and lower cutouts 224. Although not particularly limited, the connecting region 223 is located in the center of the first region 221 and the second region 222 in the up-down direction.

[0033] The inflow channel 32 connects the inflow tube 12 and the first storage chamber 26. The inflow channel 32 is connected to the upper end of the first storage chamber 26 of the collection bag 14A.

[0034] The first storage chamber 26 is formed in the first region 221 of the sheet portion 22. 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. In the first storage chamber 26, one flexible sheet 22a and the other flexible sheet 22b are spaced apart in the thickness direction. The first storage chamber 26 has a capacity for storing a predetermined amount (e.g., approximately 8 mL to approximately 10 mL) of platelet preparation.

[0035] The first storage chamber 26 has an upper portion 261, a lower portion 262, and an intermediate portion 263. Hereinafter, the upper portion 261, the lower portion 262, and the intermediate portion 263 of the first storage chamber 26 will be referred to as the "first upper portion 261," the "first lower portion 262," and the "first intermediate portion 263," respectively. The first upper portion 261 has a generally triangular shape whose width gradually decreases toward the top. Therefore, the first upper portion 261 has a pair of oblique sides 264 that are inclined with respect to the width direction of the collection bag 14A. The inflow flow path 32 is connected to the upper end of the first upper portion 261. The first lower portion 262 has a generally triangular shape whose width gradually decreases toward the bottom. The first intermediate portion 263 is located between the first upper portion 261 and the first lower portion 262 and has a constant width in the vertical direction.

[0036] The first outlet flow path 34 is connected to the lower end (the lower end of the first lower portion 262) of the first storage chamber 26. The first outlet flow path 34 extends downward from the lower end of the first storage chamber 26. The first outlet flow path 34 is a flow path for transporting the sample to be collected toward the first sampling container 51.

[0037] The second storage chamber 28 is formed in the second region 222 of the sheet portion 22. 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. In the second storage chamber 28, one flexible sheet 22a and the other flexible sheet 22b are spaced apart in the thickness direction. 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. Note that the volumes of the first storage chamber 26 and the second storage chamber 28 may be different from each other.

[0038] The second storage chamber 28 has an upper portion 281, a lower portion 282, and an intermediate portion 283. Hereinafter, the upper portion 281, the lower portion 282, and the intermediate portion 283 of the second storage chamber 28 will also be referred to as the "second upper portion 281," the "second lower portion 282," and the "second intermediate portion 283," respectively. The second upper portion 281 has a generally triangular shape whose width gradually decreases toward the top. Therefore, the second upper portion 281 has a pair of oblique sides 284 that are inclined with respect to the width direction of the collection bag 14A. The second lower portion 282 also has a generally triangular shape whose width gradually decreases toward the bottom. The second intermediate portion 283 is located between the second upper portion 281 and the second lower portion 282 and has a constant width in the vertical direction.

[0039] 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.

[0040] The connecting flow path 30 is a flow path that connects the first storage chamber 26 and the second storage chamber 28. The upstream end 30a of the connecting flow path 30 is connected to the upper portion 261 of the first storage chamber 26. The connecting flow path 30 extends diagonally upward from the upstream end 30a, curves at the apex 30b, and extends downward. The connecting flow path 30 extends downward downstream of the apex 30b to the center of the collection bag 14A in the vertical direction, and then bends in the width direction at a bend 30c. The connecting flow path 30 forms an intermediate portion 30d downstream of the bend 30c that extends in the width direction away from the first storage chamber 26.

[0041] The intermediate portion 30d of the connecting flow path 30 extends along the connecting region 223 of the seat portion 22 and is connected to the second region 222. The connecting flow path 30 has a bent portion 30e downstream of the intermediate portion 30d. The connecting flow path 30 bends downward at the bent portion 30e. The connecting flow path 30 changes direction at a turn-back portion 30f downstream of the bent portion 30e. The downstream end 30g of the connecting flow path 30 is located downstream of the turn-back portion 30f and connects to the lower portion 282 of the second storage chamber 28.

[0042] The collection bag 14A further includes an exhaust unit 40 for exhausting air from the first storage chamber 26 and the second storage chamber 28 to the outside of the collection bag 14A. In the present embodiment, the exhaust unit 40 is disposed on a wall 48 that defines the second storage chamber 28. The wall 48 is a part of one of the flexible sheets 22a. The exhaust unit 40 is disposed on the wall 48 of the flexible sheet 22a that defines a second upper portion 281 of the second storage chamber 28. More specifically, the exhaust unit 40 is disposed near the upper end of the second upper portion 281 (at a position adjacent to the upper end of the second upper portion 281).

[0043] 2, the exhaust unit 40 has a filter 42 and annular frame members 44 and 45 that sandwich the filter 42 from both sides. An opening 49 is provided in a wall portion 48 of the flexible sheet 22a, and the exhaust unit 40 is arranged to overlap the opening 49. Therefore, the filter 42 faces the opening 49. The exhaust unit 40 is joined (adhered or welded) to the wall portion 48.

[0044] The filter 42 has the function of allowing gas to pass through and preventing liquid from passing through. In this embodiment, the filter 42 is a hydrophilic filter 42a. The hydrophilic filter 42a 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 42a comes into contact with the sample as the second storage chamber 28 is filled with the sample, the pores of the hydrophilic filter 42a are blocked by the liquid that constitutes the sample, and thereafter the exhaust unit 40 prevents gas and liquid from passing through.

[0045] 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 sample from the first storage chamber 26 toward the first sampling container 51 (see FIG. 4). The first outlet port 15 is connected to the first adapter 21a. The first outlet port 15 protrudes from the sampling bag 14A.

[0046] 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.

[0047] 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. 4). The second outlet port 17 is connected to the second adapter 21b. The second outlet port 17 protrudes from the collection bag 14A.

[0048] 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.

[0049] 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.

[0050] The needle 82 can be inserted into the rubber stopper 93 (see FIG. 4 ) 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, and the needle 82 penetrates 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.

[0051] 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.

[0052] 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.

[0053] 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.

[0054] 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. 4 ) using the collection kit 10A.

[0055] As shown in Figure 3, 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.

[0056] 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.

[0057] The platelet preparation flows out of the platelet bag 57 due to gravity and flows into the collection bag 14A via the inflow tube 12. The platelet preparation that has flowed into the collection bag 14A flows into the first storage chamber 26 via the inflow channel 32. 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 out by the platelet preparation and is discharged from the exhaust section 40 via the connecting channel 30 and the second storage chamber 28.

[0058] When the first storage chamber 26 is filled with the platelet preparation, the platelet preparation flows into the upstream end 30a of the connecting flow path 30. The platelet preparation then flows from upstream to downstream through the connecting flow path 30 and flows into the second storage chamber 28 from the lower part 282 of the second storage chamber 28. As the inflow of the platelet preparation progresses, the liquid level of the platelet preparation inside the second storage chamber 28 rises. Air in the second storage chamber 28 is exhausted through the exhaust part 40.

[0059] When the second storage chamber 28 is filled with the platelet preparation and the filter 42 of the exhaust unit 40 comes into contact with the platelet preparation and becomes wet, the exhaust unit 40 closes, and the inflow of the platelet preparation into the second storage chamber 28 is stopped. This completes the introduction of the platelet preparation into the collection bag 14A. The first storage chamber 26 and the second storage chamber 28 each contain a predetermined amount (e.g., approximately 8 mL to 10 mL) of the platelet preparation.

[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 first 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 4, operations (connecting step, closing 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] In the closing step, the tubular portion 31 of the connecting flow path 30 is closed by the clamp 60. By closing the tubular portion 31, movement of fluid between the first storage chamber 26 and the second storage chamber 28 is prevented.

[0064] It is noted that the order of the connecting step and the closing step does not matter. The tubular portion 31 may be closed while being cut using a tube sealer. Alternatively, the tubular portion 31 may be closed by welding the two flexible sheets 22a, 22b at the tubular portion 31 using ultrasonic sealing or high-frequency sealing. In this case, it is not necessary to provide the clamps 60 in the circuit beforehand.

[0065] 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). As a result, a predetermined amount of platelet product is 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). As a result, a predetermined amount of platelet product is introduced into the second sampling container 52.

[0066] 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.

[0067] Through the above steps, collection of the collection subject (platelet preparation) using collection kit 10A is completed.

[0068] 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.

[0069] The first embodiment has the following advantages.

[0070] 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.

[0071] The collection kit 10A can reliably separate the first storage chamber 26 and the second storage chamber 28 by closing the tubular portion 31 of the collection bag 14A with an appropriate closing portion (clamp 60 or welding), thereby preventing the movement of the collection target between the first storage chamber 26 and the second storage chamber 28. Therefore, the collection kit 10A can reduce variation in the amount of collection target introduced into the first sampling container 51 and the second sampling container 52.

[0072] Because the exhaust unit 40 is provided on the wall 48 (part of the flexible sheet 22a) that forms the collection bag 14A, the structure of the collection kit 10A can be simplified compared to a configuration in which the exhaust unit 40 is provided on a tube that protrudes from the collection bag 14A. In other words, the collection kit 10A does not have an exhaust tube extending from the collection bag 14A.

[0073] The exhaust section 40 is disposed at the upper part of the wall section 48. With this configuration, the collection target material is stored in the second storage chamber 28 from the lower part 282 of the second storage chamber 28, so that air can be efficiently exhausted from inside the second storage chamber 28.

[0074] The exhaust unit 40 has a hydrophilic filter 42 a. The hydrophilic filter 42 a allows gas to pass through before it is wet with liquid, but prevents gas from passing through after it is wet with liquid, making it suitable as a member for exhausting air from the first storage chamber 26 and the second storage chamber 28.

[0075] Since the collection kit 10A initially includes multiple adapters (first adapter 21a and second adapter 21b), there is no need to connect multiple adapters to the collection kit 10A when using the collection kit 10A, and collection work can be performed efficiently.

[0076] The connecting flow path 30 connects the upper portion 261 of the first storage chamber 26 and the lower portion 282 of the second storage chamber 28, and the exhaust unit 40 is provided on the wall portion 48 that forms the second storage chamber 28. With this configuration, the air inside the first storage chamber 26 moves to the second storage chamber 28 via the connecting flow path 30 and is exhausted from the exhaust unit 40. Therefore, of the first storage chamber 26 and the second storage chamber 28, the exhaust unit 40 only needs to be located in the second storage chamber 28. In other words, only one exhaust unit 40 is provided in the collection kit 10A.

[0077] Next, a collection kit 10B according to a second embodiment will be described with reference to FIGS.

[0078] Collection kit 10B is typically used in a position where the up-down direction in Figures 5 to 7 is aligned with the vertical direction. For this reason, in the following description, with respect to collection kit 10B, the up-down direction in Figures 5 to 7 will also be referred to as the "up-down direction," and the left-right direction in Figures 5 to 7 will also be referred to as the "width direction."

[0079] The collection kit 10B according to the second embodiment differs from the collection kit 10A according to the first embodiment shown in FIG. 1 in the configuration of the collection bag 14B. As shown in FIG. 5, the collection bag 14B has two flexible sheets 62a, 62b stacked in the thickness direction. A common flow path 64, multiple storage chambers, a connecting flow path 66, and multiple outlet flow paths are formed between the two flexible sheets 62a, 62b. The multiple storage chambers include a first storage chamber 26 and a second storage chamber 28. The multiple outlet flow paths include a first outlet flow path 34 and a second outlet flow path 36. The collection bag 14B may have three or more storage chambers and three or more outlet flow paths.

[0080] In the initial state of the collection kit 10B, the common flow path 64, the first storage chamber 26, the second storage chamber 28, the connecting flow path 66, the first outflow flow path 34, and the second outflow flow path 36 bulge in the thickness direction of the collection bag 14B. Therefore, the two flexible sheets 62a, 62b are spaced apart from each other in the thickness direction at the common flow path 64, the first storage chamber 26, the second storage chamber 28, the connecting flow path 66, the first outflow flow path 34, and the second outflow flow path 36.

[0081] When viewed in the thickness direction of the collection bag 14B, the collection bag 14B has a rectangular shape with the long side extending widthwise and the short side extending up and down. Therefore, as shown in Figure 5, the collection bag 14B has a bottom side 141 and a top side 142 extending widthwise, and a right side 143 and a left side 144 extending up and down.

[0082] The configurations of the first storage chamber 26, the second storage chamber 28, the first outflow flow path 34, and the second outflow flow path 36 of the collection bag 14B are the same as the configurations of the first storage chamber 26, the second storage chamber 28, the first outflow flow path 34, and the second outflow flow path 36 of the collection bag 14A shown in Figure 1.

[0083] As shown in FIG. 5 , the common flow channel 64 has an upstream end 64a and a downstream end 64b. The upstream end 64a of the common flow channel 64 is connected downstream of the inlet tube 12. The downstream end 64b of the common flow channel 64 is located near the lower edge 141 of the collection bag 14B. The common flow channel 64 extends vertically from the upper edge 142 to the lower edge 141, dividing the collection bag 14B approximately in half in the width direction. The common flow channel 64 divides the collection bag 14B into a first region R1 on one side in the width direction and a second region R2 on the other side in the width direction. The first storage chamber 26 and the first outlet flow channel 34 are located in the first region R1. The second storage chamber 28 and the second outlet flow channel 36 are located in the second region R2.

[0084] The connecting flow path 66 has a first branch path 66a that branches off from the common flow path 64 and communicates with the first storage chamber 26, and a second branch path 66b that branches off from the common flow path 64 and communicates with the second storage chamber 28. The first branch path 66a and the second branch path 66b form a V-shape with their apexes facing downward (open at the top). The intersection angle θ1 between the axis Ax of the common flow path 64 and the axis A1 of the first branch path 66a is, for example, 10° to 85°. The intersection angle θ2 between the axis Ax of the common flow path 64 and the axis A2 of the second branch path 66b is also, for example, 10° to 85°.

[0085] The intersection angles θ1 and θ2 are preferably 45° to 85°, and more preferably 75° to 85°. The intersection angles θ1 and θ2 may be obtuse angles. In this case, the first branch path 66a and the second branch path 66b form a V-shape with the top facing upward (open at the bottom). The intersection angles θ1 and θ2 may be different from each other. The flow path length of the first branch path 66a and the flow path length of the second branch path 66b may be different from each other.

[0086] A downstream end 661 of the first branched channel 66a is connected to the first outflow channel 34. More specifically, the downstream end 661 of the first branched channel 66a is connected between the center and the upper end of the first outflow channel 34 in the extension direction (at a location close to the first storage chamber 26). The first storage chamber 26 communicates with the common channel 64 via the first outflow channel 34 and the first branched channel 66a. Alternatively, the downstream end 661 of the first branched channel 66a may be directly connected to the lower portion 262 of the first storage chamber 26 without being connected to the first outflow channel 34.

[0087] The downstream end 662 of the second branched passage 66b is connected to the second outflow passage 36. More specifically, the downstream end 662 of the second branched passage 66b is connected between the center and the upper end of the second outflow passage 36 in the extension direction (at a point close to the second storage chamber 28). The second storage chamber 28 communicates with the common passage 64 via the second outflow passage 36 and the second branched passage 66b. Alternatively, the downstream end 662 of the second branched passage 66b may be directly connected to the lower portion 282 of the second storage chamber 28 without being connected to the second outflow passage 36.

[0088] The collection bag 14B further includes an exhaust section 71 (hereinafter also referred to as the "first exhaust section 71") for discharging the air inside the first storage chamber 26 to the outside of the collection bag 14B, and an exhaust section 72 (hereinafter also referred to as the "second exhaust section 72") for discharging the air inside the second storage chamber 28 to the outside of the collection bag 14B.

[0089] The first exhaust section 71 is disposed on a wall section 46 that forms the first storage chamber 26. The wall section 46 is a part of one of the flexible sheets 62a. The first exhaust section 71 is disposed on the wall section 46 of the flexible sheet 62a that forms a first upper section 261 of the first storage chamber 26. More specifically, the first exhaust section 71 is disposed near the upper end of the first upper section 261 (at a position adjacent to the upper end of the first upper section 261).

[0090] The second exhaust section 72 is disposed on a wall section 48 that forms the second storage chamber 28. The wall section 48 is a part of one of the flexible sheets 62a. The second exhaust section 72 is disposed on a wall section 48 of the flexible sheet 62a that forms a second upper section 281 of the second storage chamber 28. More specifically, the second exhaust section 72 is disposed near the upper end of the second upper section 281 (at a position adjacent to the upper end of the second upper section 281).

[0091] The configuration of each of the first exhaust section 71 and the second exhaust section 72 is the same as the configuration of the exhaust section 40 shown in Fig. 2. Note that when the collection bag 14B shown in Fig. 5 has three or more storage chambers, an exhaust section is disposed in the wall section forming each storage chamber. In other words, the same number of exhaust sections as the number of storage chambers are provided.

[0092] 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.

[0093] 6, tubing 58 of platelet bag 57 is joined to inlet tubing 12 of collection kit 10B. Tubing 58 is joined to inlet tubing 12 using a sterile joining device without contacting the outside air.

[0094] Next, the platelet product is introduced into the collection bag 14B. In this step, the platelet bag 57 is positioned above the collection bag 14B. The first sealing member 16 and the second sealing member 18 of the collection kit 10B are maintained in a closed state.

[0095] The platelet preparation flows out of the platelet bag 57 due to gravity and flows into the common flow channel 64 via the inflow tube 12. The platelet preparation moves due to gravity along the common flow channel 64 toward the lower edge portion 141 of the collection bag 14B. The platelet preparation is divided into a first branch flow MF1 that flows from the common flow channel 64 into the first branch flow channel 66a and a second branch flow MF2 that flows from the common flow channel 64 into the second branch flow channel 66b.

[0096] The first branch path 66a is inclined upward as it moves away from the common flow path 64 and closer to the first storage chamber 26. Therefore, the first branch flow MF1 rises as it moves through the first branch path 66a toward the first storage chamber 26. The air in the first branch path 66a is pushed evenly by the rising first branch flow MF1 and moves toward the first storage chamber 26. This reduces the amount of air remaining in the first branch path 66a. Because the first sealing member 16 is closed at this point, the first branch flow MF1 flows into the first outlet flow path 34 and then into the first storage chamber 26. Therefore, at least a portion of the air in the first outlet flow path 34 is pushed out by the first branch flow MF1 and moves to the first storage chamber 26. This reduces the amount of air remaining in the first outlet flow path 34.

[0097] As the first branch flow MF1 further flows into the first storage chamber 26, the liquid level of the platelet preparation rises in the first storage chamber 26. As a result, the air in the first storage chamber 26 is pushed up by the platelet preparation and is discharged to the outside of the collection bag 14B via the first exhaust part 71. When the first storage chamber 26 is filled with the platelet preparation and the filter 42 of the first exhaust part 71 comes into contact with the platelet preparation and becomes wet, the first exhaust part 71 closes, and the inflow of the platelet preparation into the first storage chamber 26 stops.

[0098] Meanwhile, the second tributary flow MF2 flowing into the second outlet flow path 36 via the second branch path 66b is also received in the second storage chamber 28 in the same manner as described above. That is, the platelet preparation in the second tributary flow MF2 flows through the second branch path 66b toward the second storage chamber 28 and then flows into the second storage chamber 28 via the second outlet flow path 36. As the platelet preparation flows into the second storage chamber 28, the liquid level of the platelet preparation rises in the second storage chamber 28. As the liquid level rises, the air in the second storage chamber 28 is pushed up by the platelet preparation, and the air is discharged to the outside of the collection bag 14B via the second exhaust part 72. When the second storage chamber 28 is filled with the platelet preparation and the filter 42 of the second exhaust part 72 comes into contact with the platelet preparation and becomes wet, the second exhaust part 72 closes, and the inflow of the platelet preparation into the second storage chamber 28 stops.

[0099] The introduction of the platelet preparation into the collection bag 14B is completed by stopping the inflow of the platelet preparation into the first storage chamber 26 and the second storage chamber 28. A predetermined amount (e.g., approximately 8 mL to 10 mL) of the platelet preparation is stored in each of the first storage chamber 26 and the second storage chamber 28.

[0100] Thereafter, the platelet bag 57 is separated from the inflow tube 12 by 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.

[0101] 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, closing step, 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.

[0102] 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.

[0103] In the closing step, a closing step is performed to block communication between the first storage chamber 26 and the second storage chamber 28. In the closing step, for example, as shown in FIG. 7 , a welded seal portion 88 is formed in each of the first branched channel 66a and the second branched channel 66b in the collection bag 14B. The welded seal portion 88 can be formed by welding two flexible sheets 62a, 62b together using, for example, an ultrasonic sealer or a high-frequency sealer. Instead of the welded seal portion 88, multiple clamps such as clamps may be used to block communication between each of the first branched channel 66a and the second branched channel 66b and the common flow path 64.

[0104] This blocking makes the first storage chamber 26 and the second storage chamber 28 independent of each other, thereby preventing the platelet preparation from moving between the first storage chamber 26 and the second storage chamber 28. Note that either the connecting step or the closing step may be performed first.

[0105] 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). As a result, a predetermined amount of platelet product is 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). As a result, a predetermined amount of platelet product is introduced into the second sampling container 52.

[0106] 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.

[0107] Through the above steps, collection of a platelet preparation using collection kit 10B is completed.

[0108] 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.

[0109] The collection kit 10B according to the second embodiment has the following advantages.

[0110] In collection kit 10B, the collection target flows into first storage chamber 26 and second storage chamber 28 via first branch path 66a and second branch path 66b, respectively, and the air inside first storage chamber 26 and second storage chamber 28 is exhausted from first exhaust section 71 and second exhaust section 72, respectively. Therefore, air can be efficiently exhausted from inside first storage chamber 26 and second storage chamber 28.

[0111] In the second embodiment, the parts common to the first embodiment provide the same or similar functions and effects as the first embodiment.

[0112] 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: an inflow tube to which the medical bag is connected; and a collection bag connected downstream of the inflow tube and formed by overlapping and welding two flexible sheets, wherein the collection bag has: a plurality of storage chambers for storing the samples; a connecting flow path connecting the plurality of storage chambers; an exhaust section disposed in a wall portion forming at least one of the plurality of storage chambers for discharging air inside the plurality of storage chambers to the outside of the collection bag; and a plurality of outflow ports respectively connected to the plurality of storage chambers and for transporting the samples from the plurality of storage chambers to the plurality of sampling containers.

2. A collection kit as described in claim 1, wherein the collection bag has a first end to which the inflow tube is connected and a second end opposite the first end and provided with a plurality of the outflow ports, the collection kit is configured for use in a position in which the second end is lower than the first end, and the exhaust section is located at the upper part of the wall section.

3. A collection kit according to claim 1, wherein the exhaust portion has a hydrophilic filter.

4. 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.

5. A collection kit according to any one of claims 1 to 4, wherein the plurality of storage chambers include a first storage chamber and a second storage chamber, the collection bag has an inlet flow path connecting the inlet tube and the first storage chamber, the upstream end of the connecting flow path is connected to the first storage chamber, and the downstream end of the connecting flow path is connected to the second storage chamber, and the exhaust section is provided in a wall portion forming the second storage chamber.

6. A collection kit as claimed in any one of claims 1 to 4, wherein the plurality of storage chambers include a first storage chamber and a second storage chamber, the collection bag has a common flow path connected downstream of the inflow tube, the connecting flow path has a first branch path branching from the common flow path and communicating with the first storage chamber, and a second branch path branching from the common flow path and communicating with the second storage chamber, and the exhaust section has a first exhaust section arranged in a wall portion forming the first storage chamber, and a second exhaust section arranged in a wall portion forming the second storage chamber.

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