Collection kit

The sampling kit addresses the complexity and cost issues of existing systems by using a simplified structure with multiple storage chambers and a single outflow port, enhancing efficiency and accuracy in transferring blood products to multiple culture bottles.

WO2025115872A1PCT designated stage expired Publication Date: 2025-06-05TERUMO KK
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Patent Information

Application Number
PCT/JP2024/041861
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-11-28
Filing Date
2024-11-26
Publication Date
2025-06-05

AI Technical Summary

Technical Problem

Current sampling kits for blood products are complex in structure and costly, with inefficient working processes for distributing blood products to multiple culture bottles, and there is a need for a system that can accurately collect a predetermined amount of the sampling object into each container.

Method used

A sampling kit with a simplified structure featuring a sampling bag with multiple storage chambers and a single outflow port, connected via inflow tubes and flow paths, allowing for efficient transfer of a predetermined amount of the sampling object into multiple sampling containers.

Benefits of technology

The sampling kit simplifies the structure and reduces costs while improving working efficiency for transferring blood products to multiple culture bottles, ensuring accurate and efficient collection of a predetermined amount into each container.

✦ Generated by Eureka AI based on patent content.

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Abstract

A collection kit (10) comprises an inflow tube (16) to which a medical bag (12) is connected and a collection bag (18) that is connected to a downstream side of the inflow tube (16). The collection bag (18) comprises: a plurality of accommodation chambers (26) for accommodating a substance (M) to be collected from the medical bag (12); one outflow port (36) for transferring the substance (M) to be collected from the plurality of accommodation chambers (26) to respective sampling containers (14); and an exhaust part (38) for expelling air inside the plurality of accommodation chambers (26).
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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) An aspect of the present invention is a collection kit for sequentially 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, wherein the collection bag has multiple storage chambers for storing the collection objects, one outlet port for transferring the collection objects from the multiple storage chambers to each of the multiple sampling containers, and an exhaust section for exhausting the air inside the multiple storage chambers.

[0010] This collection kit has only one outlet port for sequentially collecting material into multiple sampling containers, making it possible to reduce the cost of a collection kit with multiple storage chambers with a simple structure. It also improves the efficiency of collecting material into multiple sampling containers, making it possible to collect a predetermined amount of material.

[0011] (2) In the collection kit described in (1) above, a connecting flow path may be provided between the plurality of storage chambers to connect adjacent storage chambers to each other, the inlet tube may be connected to one of the plurality of storage chambers, and an outlet flow path connected to the outlet port may be connected to one of the plurality of storage chambers or another storage chamber.

[0012] This configuration allows the collection kit to be made compact in the width direction intersecting the extension direction of the connecting flow path.

[0013] (3) The collection kit described in (1) above may include a plurality of inlet tubes connected to the plurality of storage chambers, respectively, and an outlet flow path connecting the plurality of storage chambers and the outlet port.

[0014] With this configuration, by connecting a medical bag to each of the plurality of inflow tubes, the sample to be collected can be stored in each of the plurality of storage chambers from each inflow tube.

[0015] (4) In the collection kit described in (1) above, the collection bag may include a common flow path connected downstream of the inlet tube, a plurality of branch flow paths branching from the common flow path and respectively connected to a plurality of the storage chambers, and an outlet flow path connecting the plurality of storage chambers to the outlet port.

[0016] With this configuration, the collection target can be stored in a plurality of storage chambers through one common flow path.

[0017] (5) In the collection kit according to any one of (1) to (4) above, an adapter may be connected to the outlet port, to which a plurality of the sampling containers may be sequentially attached.

[0018] With this configuration, multiple sampling containers can be attached to the adapter in sequence, allowing them to be easily connected to the outlet port.

[0019] According to the present invention, the collection bag includes multiple storage chambers for storing the samples to be collected and one outlet port for transferring the samples from the storage chambers to each of the sampling containers. Since the collection kit only requires one outlet port, the collection kit having multiple storage chambers can be manufactured at low cost with a simple structure. In addition, the efficiency of collecting samples into multiple sampling containers can be improved, and a predetermined amount of samples can be collected.

[0020] FIG. 1 is a schematic front view of a collection kit according to a first embodiment of the present invention. FIG. 2 is an explanatory diagram illustrating the case where a collection target is stored in a storage chamber of the collection kit. FIG. 3A is an explanatory diagram illustrating the case where a collection target is transferred from a first storage chamber to a first sampling container. FIG. 3B is an explanatory diagram illustrating the case where a collection target is transferred from a second storage chamber to a second sampling container. FIG. 4 is a schematic front view of a collection kit according to a first modified example. FIG. 5 is a schematic front view of a collection kit according to a second modified example. FIG. 6 is a schematic front view of a collection kit according to a second embodiment of the present invention. FIG. 7A is an explanatory diagram illustrating the case where a collection target is stored in a first storage chamber of the collection kit. FIG. 7B is an explanatory diagram illustrating the case where a collection target is stored in a second storage chamber of the collection kit. FIG. 8A is an explanatory diagram illustrating the case where a collection target is transferred from a first storage chamber to a first sampling container. FIG. 8B is an explanatory diagram illustrating the case where a collection target is transferred from a second storage chamber to a second sampling container. FIG. 9 is a schematic front view of a collection kit according to a third embodiment of the present invention.

[0021] As shown in FIG. 1 , the collection kit 10 according to the first embodiment is used to transfer a collection target M contained in a medical bag 12 shown in FIG. 2 to multiple sampling containers 14 (see FIGS. 3A and 3B ). The collection target M is, for example, a blood product such as a platelet product. The collection target M may also be a pharmaceutical product other than a blood product. The collection target M may also be a liquid sample other than a pharmaceutical product. The medical bag 12 may also 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 10 may be connected to the blood bag system.

[0022] As shown in FIG. 1 , collection kit 10 includes an inflow tube 16 to which medical bag 12 (see FIG. 2 ) is connected, a collection bag 18, and an adapter 20. Adapter 20 may be detachable from collection bag 18. Hereinafter, the extension direction of inflow tube 16 (direction of arrow V) in collection kit 10 shown in FIG. 1 will be referred to as the up-down direction. The direction perpendicular to the up-down direction (direction of arrow W) will be referred to as the width direction of collection kit 10, and the direction perpendicular to the up-down direction and width direction will be referred to as the thickness direction of collection kit 10. As shown in FIG. 1 , collection kit 10 is generally used with the up-down direction aligned vertically.

[0023] The inflow tube 16 is a transparent or translucent medical tube. The inflow tube 16 is made of a thermoplastic resin such as polyvinyl chloride resin. The inflow tube 16 can be connected to or disconnected from other medical tubes without exposing the inside to the outside air by using a sterile connection device or a tube sealer.

[0024] The inflow tube 16 has an upstream end 16a and a downstream end 16b. When the collection kit 10 is initially provided as a product, the upstream end 16a is welded and sealed. The downstream end 16b is connected to the upper edge 191 of the collection bag 18 via a relay member 22. The relay member 22 is, for example, a sleeve made of a material harder than the collection bag 18.

[0025] The collection bag 18 is connected downstream of the inflow tube 16. The collection bag 18 has two flexible sheets 24 that are overlapped and welded together in the thickness direction. The collection bag 18 includes multiple storage chambers 26, an inflow flow path 28, an exhaust flow path 30, an outlet flow path 32, a connecting flow path 34, one outlet port 36, and an exhaust section 38. A portion of the inflow flow path 28, the exhaust flow path 30, the outlet flow path 32, and the multiple storage chambers 26 are disposed between the two flexible sheets 24 and each bulge in the thickness direction of the collection bag 18.

[0026] The collection bag 18 further includes a first bag 181 and a second bag 182. The first bag 181 and the second bag 182 are arranged side by side and spaced apart from each other in the vertical direction. Each of the first bag 181 and the second bag 182 is made up of two flexible sheets 24. The second bag 182 is disposed above the first bag 181. A gap 40 is provided between the first bag 181 and the second bag 182. The gap 40 is a space extending in the width direction between the first bag 181 and the second bag 182.

[0027] The collection bag 18 is not limited to being composed of a first bag 181 and a second bag 182 that are divided in the vertical direction. For example, the collection bag 18 may be composed of a single bag. In the front view of the collection bag 18 shown in FIG. 1 , each of the first bag 181 and the second bag 182 has a rectangular shape that is longer in the width direction than in the vertical direction. The first bag 181 and the second bag 182 are not limited to being rectangular shapes that are longer in the width direction. For example, the first bag 181 and the second bag 182 may be rectangular shapes that are longer in the vertical direction than in the width direction, or may be rectangular shapes whose width and vertical lengths are approximately equal.

[0028] The multiple storage chambers 26 store the collection target objects M. The multiple storage chambers 26 include a first storage chamber 261 and a second storage chamber 262. The first storage chamber 261 has an elliptical shape that is elongated in the width direction of the first bag 181. The volume of the first storage chamber 261 is, for example, approximately 8 mL to approximately 10 mL. The first storage chamber 261 temporarily stores the collection target objects M collected in the first sampling container 141. Note that the multiple storage chambers 26 are not limited to two storage chambers 26. The multiple storage chambers 26 may be three or more storage chambers.

[0029] The second storage chamber 262 has an elliptical shape that is elongated in the width direction of the second bag 182. The volume of the second storage chamber 262 is, for example, approximately 8 mL to approximately 10 mL. The volume of the second storage chamber 262 is the same as the volume of the first storage chamber 261. The second storage chamber 262 temporarily stores the collection target M to be collected in the second sampling container 142. Note that each of the first storage chamber 261 and the second storage chamber 262 is not limited to being formed in an elliptical shape. Each of the first storage chamber 261 and the second storage chamber 262 may have a shape other than an elliptical shape. Furthermore, the volume of the first storage chamber 261 and the volume of the second storage chamber 262 may be different.

[0030] The inlet flow path 28 is disposed at one end of the collection bag 18 in the width direction. The inlet flow path 28 includes a first inlet flow path 281 provided in the first bag 181, a second inlet flow path 282 provided in the second bag 182, and an intermediate flow path 283 provided between the first inlet flow path 281 and the second inlet flow path 282. The first inlet flow path 281 is provided inside the first bag 181. The first inlet flow path 281 includes a flow path main body 42 extending in the vertical direction and a folded portion 44 provided at the lower end of the flow path main body 42. The flow path main body 42 extends in the vertical direction. The folded portion 44 extends from the lower end of the flow path main body 42 toward the center in the width direction and then folded upward. The downstream end of the folded portion 44 is connected to the lower part of the first storage chamber 261.

[0031] The second inlet flow passage 282 is provided inside the second bag 182 and extends in the vertical direction. The intermediate flow passage 283 is provided in the gap 40 and is exposed to the outside of the first bag 181 and the second bag 182.

[0032] The inflow passage 28 has an upstream end 28a and a downstream end 28b. The upstream end 28a is provided at the upper end of the second inflow passage 282. The upstream end 28a is connected to the downstream end 16b of the inflow tube 16 via the relay member 22. The downstream end 28b is disposed at the end of the folded portion 44 of the first inflow passage 281. Note that the inflow passage 28 is not limited to being connected to the first storage chamber 261. For example, the inflow passage 28 may be connected to a lower portion of the second storage chamber 262.

[0033] The exhaust flow path 30 is provided in the second bag 182. The exhaust flow path 30 is connected to the uppermost part of the second storage chamber 262. The upper end of the exhaust flow path 30 is located on the upper side portion 191 of the second bag 182 and is connected to the exhaust section 38.

[0034] The outflow channel 32 is provided in the first bag 181 and extends in the vertical direction. An upper end 321 of the outflow channel 32 is connected to the lowermost part of the first storage chamber 261. That is, both the outflow channel 32 and the inflow channel 28 are connected to the first storage chamber 261. Note that the outflow channel 32 is not limited to being connected to the lowermost part of the first storage chamber 261. The outflow channel 32 only needs to be connected to at least the lower part of the first storage chamber 261. A lower end 322 of the outflow channel 32 is disposed on the lower edge portion 192 of the first bag 181. The lower end 322 of the outflow channel 32 includes one outflow port 36. The outflow port 36 is a port for transferring the collection target M from the first storage chamber 261 and the second storage chamber 262 to multiple sampling containers 14. Note that the outflow channel 32 is not limited to being connected to the first storage chamber 261. For example, the upper end 321 of the outflow channel 32 may be connected to the lowermost part of the second storage chamber 262.

[0035] Only one outflow port 36 is provided in the collection kit 10. That is, two or more outflow ports 36 are not provided. A connecting member 46 is connected to the outflow port 36. The connecting member 46 protrudes downward from the lower end of the first bag 181. The connecting member 46 has a breakable plug (not shown) therein. In the initial state, the plug seals the outflow port 36.

[0036] The connection flow path 34 extends in the vertical direction and connects the first storage chamber 261 and the second storage chamber 262. The connection flow path 34 includes a first flow path portion 341 provided in the first bag 181, a second flow path portion 342 provided in the second bag 182, and an exposed portion 343 provided between the first flow path portion 341 and the second flow path portion 342. The lower end of the first flow path portion 341 is connected to an upper portion of the first storage chamber 261. The upper end of the first flow path portion 341 is located on the upper side of the first bag 181. The upper end of the second flow path portion 342 is connected to the lowermost portion of the second storage chamber 262. Note that the upper end of the second flow path portion 342 is not limited to being connected to the lowermost portion of the second storage chamber 262. It is sufficient that the upper end of the second flow path portion 342 is connected to at least the lower portion of the second storage chamber 262. The lower end of the second flow path portion 342 is located on the lower side of the second bag 182. The exposed portion 343 connects the upper end of the first flow path portion 341 and the lower end of the second flow path portion 342. The exposed portion 343 is disposed in the gap 40 of the collection bag 18. A blocking member 48 is provided on the exposed portion 343. The blocking member 48 is, for example, a clamp. The blocking member 48 is provided so as to be able to block the flow of the collection target M in the connection flow path 34. By clamping the connection flow path 34 with the blocking member 48, communication with the connection flow path 34 is blocked. By releasing the clamping of the connection flow path 34 by the blocking member 48, the connection flow path 34 is opened. Note that the blocking member 48 may be detachable from the connection flow path 34.

[0037] The exhaust unit 38 is provided to exhaust air from the first storage chamber 261 and the second storage chamber 262. The exhaust unit 38 is connected to the upper end of the exhaust flow path 30 via an attachment member 50. The attachment member 50 provides a liquid-tight and airtight seal between the exhaust unit 38 and the collection bag 18. The exhaust unit 38 has a filter 52 that allows gas to pass through but prevents liquid from passing through. When the collection target M is primarily composed of water, the filter 52 is preferably a hydrophilic filter. In this case, when the collection target M moves to the filter 52 through the exhaust flow path 30 and comes into contact with the filter 52, the pores of the filter 52 are blocked by the liquid. After the pores of the filter 52 are blocked, the filter 52 blocks the passage of gas and liquid. Therefore, leakage of the collection target M from the first storage chamber 261 and the second storage chamber 262 to the outside is prevented. An example of a collection target M primarily composed of water is a blood product.

[0038] The exhaust unit 38 is not limited to a configuration in which it is connected to the upper end of the exhaust flow path 30 via the mounting member 50. For example, a filter 52a may be provided on the flexible sheet 24 of the collection bag 18 (see the two-dot chain line in FIG. 1 ). In this case, the filter 52a is disposed on the wall of the flexible sheet 24 facing the second storage chamber 262, and the air in the second storage chamber 262 can be directly exhausted to the atmosphere through the filter 52a.

[0039] The adapter 20 is connected to the lower end 322 of the outflow flow path 32 via a connecting member 46. The adapter 20 is positioned so as to protrude downward relative to the lower side 192 of the first bag 181. The adapter 20 has an adapter main body 54 and a communicating tube 56 provided at the upper end of the adapter main body 54. The communicating tube 56 is inserted into the inner hole of the connecting member 46, thereby connecting the adapter 20 to the outflow flow path 32. The connecting member 46 provides a liquid-tight and airtight seal between the communicating tube 56 and the collection bag 18.

[0040] The adapter 20 includes a needle tube 58 and a rubber cover 60 that covers the needle tube 58. The needle tube 58 is provided inside the adapter body 54 and is connected to the communicating tube 56. When the neck of the sampling container 14 is inserted into the adapter body 54, the needle tube 58 penetrates the stopper (not shown) of the sampling container 14 (see FIGS. 3A and 3B ). When the connecting member 46 is opened, the sampling container 14 and the first storage chamber 261 communicate with each other via the communicating tube 56 and the needle tube 58.

[0041] When the needle tube 58 is inserted into the stopper of the sampling container 14, the rubber cover 60 is compressed by being pushed toward the collection bag 18. The needle tube 58 penetrates the compressed rubber cover 60. When the needle tube 58 is removed from the stopper of the first sampling container 141, the rubber cover 60 stretches due to its elastic restoring force and covers the needle tube 58 again.

[0042] Next, a collection method for separating the collection target M into the first sampling container 141 and the second sampling container 142 using the collection kit 10 will be described.

[0043] First, as shown in Figure 2, a step of connecting the medical bag 12 to the inflow tube 16 is performed. The operator connects the medical bag 12 containing the collection object M, such as a platelet preparation, to the inflow tube 16. At this time, the medical bag 12 is positioned above the collection bag 18. The operator joins the supply tube 62 of the medical bag 12 to the inflow tube 16. At this time, the closure member 48 is in an open state, with the blocking state of the connection flow path 34 released.

[0044] Next, a step of transferring the collection target M to the first storage chamber 261 and the second storage chamber 262 is performed. The collection target M is, for example, a liquid and is flowable. Therefore, the collection target M flows out of the medical bag 12 by gravity and flows into the inlet flow path 28 via the supply tube 62 and the inlet tube 16. Specifically, the collection target M moves downward by gravity from the inlet tube 16 along the second inlet flow path 282, the intermediate flow path 283, and the first inlet flow path 281. The collection target M moves upward toward the first storage chamber 261 through the folded portion 44 of the first inlet flow path 281. The collection target M flows from the inlet flow path 28 into the first storage chamber 261.

[0045] When the collection target M flows into the first storage chamber 261, the air remaining in the first storage chamber 261 is pushed out toward the second storage chamber 262 through the connecting flow path 34. The air travels from the second storage chamber 262 through the exhaust flow path 30 and is exhausted to the atmosphere through the filter 52 of the exhaust unit 38.

[0046] After the first storage chamber 261 is filled with the collection target M, the collection target M moves to the second storage chamber 262 through the connecting flow path 34. Air remaining in the second storage chamber 262 is discharged to the atmosphere through the exhaust flow path 30 and the exhaust part 38.

[0047] After the first storage chamber 261 and the second storage chamber 262 are filled with the collection target M, the collection target M flows into the filter 52 via the exhaust flow path 30. When the collection target M comes into contact with the filter 52, the collection target M is captured and held in the pores of the filter 52. This causes the filter 52 to block the collection target M within the exhaust section 38. As a result, the exhaust section 38 is closed, and the collection target M is prevented from passing through the filter 52 and being discharged to the outside. A required amount (e.g., approximately 8 mL to 10 mL) of collection target M is stored in each of the first storage chamber 261 and the second storage chamber 262. The supply of collection target M from the medical bag 12 to the collection bag 18 stops.

[0048] Next, the medical bag 12 is separated from the inflow tube 16. At the same time that the inflow tube 16 is disconnected from the supply tube 62 of the medical bag 12, the upstream end 16a of the inflow tube 16 is sealed by welding. A tube sealer, such as a high-frequency sealer or an ultrasonic sealer, is used to seal the inflow tube 16. Once separated from the collection kit 10, the medical bag 12 is stored until the test is completed.

[0049] Next, a step is performed in which the collection target object M in the first storage chamber 261 is transferred to the first sampling container 141. At this time, as shown in Fig. 3A, this work is performed with the closure member 48 blocking communication with the connection flow path 34. That is, the closure member 48 blocks communication between the first storage chamber 261 and the second storage chamber 262, preventing movement of the collection target object M between the first storage chamber 261 and the second storage chamber 262.

[0050] The first sampling container 141 is connected to the adapter 20. The lid 64 of the adapter 20 is opened, and the neck of the first sampling container 141 is inserted into the adapter body 54. This causes the needle tube 58 provided inside the adapter body 54 to pierce the stopper of the first sampling container 141.

[0051] The operator bends the plug of the connecting member 46 to break it, opening the outflow flow path 32. The collection target M in the first storage chamber 261 is sucked out by the negative pressure in the first sampling container 141, passes through the outflow flow path 32, the outflow port 36, the connecting member 46, the communicating tube portion 56 of the adapter 20, and the needle tube 58, and flows into the first sampling container 141. At this time, because communication with the connecting flow path 34 is blocked by the blocking member 48, the collection target M in the second storage chamber 262 is not sucked out through the outflow flow path 32. As a result, substantially the entire amount of the collection target M stored in the first storage chamber 261 is transferred to the first sampling container 141. The amount of the collection target M in the first sampling container 141 is, for example, approximately 8 mL to 10 mL.

[0052] 3B , after the first sampling container 141 is removed from the adapter 20, the second sampling container 142 is connected to the adapter 20 and the sample target M in the second storage chamber 262 is transferred to the second sampling container 142. The connection of the second sampling container 142 is the same as the connection of the first sampling container 141, and therefore a detailed description of the connection between the adapter 20 and the second sampling container 142 will be omitted.

[0053] After connecting the second sampling container 142, the blocking state of the connection flow path 34 by the blocking member 48 is released. By opening the connection flow path 34, the collection target M in the second storage chamber 262 is sucked out by the negative pressure within the second sampling container 142. The collection target M passes from the second storage chamber 262 through the connection flow path 34, the first storage chamber 261, the outflow flow path 32, the outflow port 36, the connecting member 46, the communicating tube portion 56 of the adapter 20, and the needle tube 58, and flows into the second sampling container 142. As a result, substantially the entire amount of the collection target M stored in the second storage chamber 262 is transferred to the second sampling container 142. The amount of the collection target M in the second sampling container 142 is, for example, approximately 8 mL to 10 mL. The second sampling container 142 is then removed from the adapter 20. This completes the collection (sampling) of the collection target M using the collection kit 10. That is, a first sample MS 1 is introduced into a first sampling container 141 , and a second sample MS 2 is introduced into a second sampling container 142 .

[0054] If the collection target M is a blood product, a culture test is performed on the first sample MS1 and the second sample MS2. Specifically, the first sample MS1 in the first sampling container 141 is used, for example, for anaerobic culture to observe whether anaerobic bacteria grow. The second sample MS2 in the second sampling container 142 is used, for example, for aerobic culture to observe whether aerobic bacteria grow. In both tests, the first sampling container 141 and the second sampling container 142 are used as culture bottles. If the first sample MS1 and the second sample MS2 pass the culture test, the collection target M in the medical bag 12 from which the first sample MS1 and the second sample MS2 were collected is determined to be an acceptable product. The acceptable product is used for patient treatment (such as blood transfusion).

[0055] The first embodiment has the following advantages.

[0056] As shown in FIG. 1 , the collection kit 10 includes a collection bag 18 connected downstream of the inlet tube 16. The collection bag 18 includes multiple storage chambers 26 (first storage chamber 261, second storage chamber 262) for storing the collection objects M stored in the medical bag 12, and one outlet port 36 for transferring the collection objects M from the multiple storage chambers 26 to multiple sampling containers 14 (first sampling container 141, second sampling container 142) (see FIGS. 3A and 3B ). Because the collection kit 10 includes only one outlet port 36, the collection kit 10, which has multiple storage chambers 26, can be manufactured at low cost with a simple structure. Furthermore, the efficiency of collecting the collection objects M into the multiple sampling containers 14 can be improved, allowing a predetermined amount of the collection objects M to be collected.

[0057] The collection bag 18 includes a connecting flow path 34 that is provided between the plurality of storage chambers 26 and connects adjacent first storage chambers 261 and second storage chambers 262. The inflow tube 16 is connected to one first storage chamber 261 of the plurality of storage chambers 26, and the outflow flow path 32, which is connected to the outflow port 36, is connected to the first storage chamber 261 of the plurality of storage chambers 26. This allows the collection kit 10 to be configured compactly in the width direction of the collection bag 18, which intersects with the extension direction of the connecting flow path 34.

[0058] 3A and 3B, an adapter 20 is connected to the outlet port 36, to which a first sampling container 141 and a second sampling container 142 are sequentially attached. This allows multiple first sampling containers 141 and second sampling containers 142 to be attached to the adapter 20, making it possible to easily connect them to the outlet port 36.

[0059] The collection kit 10 is not limited to the case in which the first storage chamber 261 and the second storage chamber 262 are arranged side by side in the vertical direction (the direction of arrow V) as shown in FIG. 1 . For example, the collection kit 101A according to a first modified example shown in FIG. 4 includes a collection bag 18C having a first bag 181A and a second bag 182A. The first bag 181A and the second bag 182A are arranged side by side in the width direction (the direction of arrow W). The first bag 181A has a first storage chamber 261. The second bag 182A has a second storage chamber 262. The first storage chamber 261 of the first bag 181A and the second storage chamber 262 of the second bag 182A are connected by a connection flow path 34A. A blocking member 48 is provided in the connection flow path 34A. An inlet tube 16 is connected to the first bag 181A so as to communicate with the first storage chamber 261. The second bag 182A includes an outlet port 36 and an exhaust section 38. The outlet port 36 communicates with the second storage chamber 262 and is connected to the adapter 20. The exhaust section 38 communicates with the second storage chamber 262. A closing member 48 can switch the communication state between the first storage chamber 261 and the second storage chamber 262 via the connection flow path 34A.

[0060] A collection kit 101B according to a second modified example shown in FIG. 5 includes a collection bag 18D having a first bag 181B and a second bag 182B. The first bag 181B and the second bag 182B are arranged side by side in the width direction (the direction of the arrow W). A first storage chamber 261 of the first bag 181B and a second storage chamber 262 of the second bag 182B are connected by a connection flow path 34B. A blocking member 48 is provided in the connection flow path 34B. An inflow tube 16 is connected to the first bag 181B so as to communicate with the first storage chamber 261. The first bag 181B includes an outflow port 36. The outflow port 36 communicates with the first storage chamber 261 and is connected to the adapter 20. The second bag 182B includes an exhaust section 38. The exhaust section 38 communicates with the second storage chamber 262. The closing member 48 can switch between a communication state between the first storage chamber 261 and the second storage chamber 262 via the connection flow path 34B.

[0061] As shown in Figure 6, the collection kit 10A according to the second embodiment includes a plurality of inlet tubes 16A and a collection bag 18A. The collection bag 18A has a first region 18L and a second region 18R. The first region 18L is located to the left of the center in the width direction of the collection bag 18A. The second region 18R is located to the right of the center in the width direction of the collection bag 18A. Note that the same reference numerals are used to designate components similar to those of the collection kit 10 according to the first embodiment, and detailed descriptions of the same components will be omitted.

[0062] The multiple inflow tubes 16A are a first inflow tube 161 and a second inflow tube 162. The first inflow tube 161 and the second inflow tube 162 extend in the vertical direction and are arranged parallel to each other and spaced apart in the width direction. Note that the multiple inflow tubes 16A are not limited to two, the first inflow tube 161 and the second inflow tube 162. As long as the number of inflow tubes 16A is the same as the number of storage chambers 26, there may be three or more inflow tubes 16A.

[0063] In the width direction of the collection bag 18A, the first inflow tube 161 faces the first region 18L. The first inflow tube 161 is arranged closer to the center of the collection bag 18A in the width direction in the first region 18L. The downstream end 16b of the first inflow tube 161 is connected to the upper edge portion 191 of the first region 18L of the collection bag 18A via the relay member 22. The downstream end 16b of the first inflow tube 161 is connected to the inflow flow path 284. In the width direction of the collection bag 18A, the second inflow tube 162 faces the second region 18R. The second inflow tube 162 is arranged closer to the center of the collection bag 18A in the width direction in the second region 18R. That is, the first inflow tube 161 and the second inflow tube 162 are arranged adjacent to each other in the width direction of the collection bag 18A. The downstream end 16b of the second inflow tube 162 is connected to the upper edge portion 191 of the second region 18R of the collection bag 18A via the relay member 22. The downstream end 16b of the second inflow tube 162 is connected to the inflow flow path 285.

[0064] The collection bag 18A includes an outflow passage 32A that connects the first storage chamber 261 and the second storage chamber 262 with the outflow port 36. The outflow passage 32A includes a first outlet portion 701 connected to the lowermost portion of the first storage chamber 261, a second outlet portion 702 connected to the lowermost portion of the second storage chamber 262, and a common connection portion 703 that connects the first outlet portion 701 and the second outlet portion 702. Note that the first outlet portion 701 is not limited to being connected to the lowermost portion of the first storage chamber 261. It is sufficient that the first outlet portion 701 is connected to at least the lower portion of the first storage chamber 261. The second outlet portion 702 is not limited to being connected to the lowermost portion of the second storage chamber 262. It is sufficient that the second outlet portion 702 is connected to at least the lower portion of the second storage chamber 262.

[0065] The first outlet 701 is connected to the lowermost part of the first storage chamber 261 and extends in the vertical direction. The lower end of the first outlet 701 extends to the lower side 192 of the collection bag 18A. The second outlet 702 is connected to the lowermost part of the second storage chamber 262 and extends in the vertical direction. The lower end of the second outlet 702 extends to the lower side 192 of the collection bag 18A.

[0066] The common connection portion 703 is exposed to the outside of the collection bag 18A and extends in the width direction. The common connection portion 703 is disposed substantially parallel to and spaced downward from the bottom edge portion 192 of the collection bag 18A. One widthwise end of the common connection portion 703 is connected to the bottom end of the first outlet portion 701. The other widthwise end of the common connection portion 703 is connected to the bottom end of the second outlet portion 702. The center of the width direction of the common connection portion 703 is provided with one outlet port 36.

[0067] A first closing member 481 is provided in the common connection portion 703 at a position between the outflow port 36 and the first outflow portion 701. The first closing member 481 is, for example, a clamp. A second closing member 482 is provided in the common connection portion 703 at a position between the outflow port 36 and the second outflow portion 702. The second closing member 482 is, for example, a clamp. The first closing member 481 can block communication between the first storage chamber 261 and the outflow port 36. The second closing member 482 can block communication between the second storage chamber 262 and the outflow port 36.

[0068] Note that the outflow channel 32A is not limited to being partially exposed to the outside of the collection bag 18A. For example, as shown by the two-dot chain line in Figure 6, the entire outflow channel 32A may be contained and covered inside the collection bag 18A.

[0069] Next, a collection method for separating the collection target M into the first sampling container 141 and the second sampling container 142 using the collection kit 10A will be described.

[0070] 7A, the medical bag 12 is connected to the first inflow tube 161. At this time, the first closing member 481 and the second closing member 482 block communication between the outflow port 36 and the first and second storage chambers 261 and 262 through the common connection portion 703.

[0071] The collection target M flows out of the medical bag 12 due to gravity and moves through the first inflow tube 161 and the inflow passage 284 into the first storage chamber 261. The air in the inflow passage 284 and the first storage chamber 261 is discharged to the atmosphere through the first exhaust section 381 that communicates with the first storage chamber 261. The first storage chamber 261 is filled with the collection target M, and the collection target M flows into the first exhaust section 381, so that the required amount of collection target M is stored in the first storage chamber 261.

[0072] Next, as shown in FIG. 7B , the medical bag 12 is separated from the first inlet tube 161 and connected to the second inlet tube 162. At this time, the upstream end 16a of the first inlet tube 161 is sealed by welding. Gravity causes the collection target M to flow out of the medical bag 12 and into the second storage chamber 262 via the second inlet tube 162 and the inlet flow path 285. Air within the inlet flow path 285 and the second storage chamber 262 is exhausted to the atmosphere via the second exhaust section 382, ​​which communicates with the second storage chamber 262. When the second storage chamber 262 is filled with the collection target M, the collection target M flows into the second exhaust section 382, ​​allowing the second storage chamber 262 to accommodate a required amount of collection target M. The collection kit 10A is not limited to having two exhaust sections, a first exhaust section 381 and a second exhaust section 382. For example, a single exhaust section may be provided in the exhaust flow paths connected to the first storage chamber 261 and the second storage chamber 262.

[0073] After separating the medical bag 12 from the second inflow tube 162 and sealing the upstream end 16a of the second inflow tube 162 by welding, the first sampling container 141 is connected to the adapter 20 as shown in Figure 8A. The operator bends and breaks the plug of the connecting member 46, opening the outflow flow path 32A. Furthermore, by releasing the blocking state of the outflow flow path 32A by the first closure member 481, the collection target M in the first storage chamber 261 is sucked out by negative pressure and transferred to the first sampling container 141 through the outflow flow path 32A, the outflow port 36, and the adapter 20.

[0074] Next, after removing the first sampling container 141 from the adapter 20, the outflow flow path 32A is again blocked by the first closing member 481. As shown in FIG. 8B , the second sampling container 142 is connected to the adapter 20, and the blocking state of the outflow flow path 32A by the second closing member 482 is released. This causes the collection target M in the second storage chamber 262 to be sucked out by negative pressure and transferred to the second sampling container 142 through the outflow flow path 32A, the outflow port 36, and the adapter 20. At this time, the first closing member 481 blocks communication between the first storage chamber 261 and the outflow flow path 32A. The second sampling container 142 is then removed from the adapter 20. This completes collection (sampling) of the collection target M using the collection kit 10A.

[0075] The second embodiment has the following advantages.

[0076] 7A and 7B, the collection kit 10A includes a plurality of first inlet tubes 161 and second inlet tubes 162 connected to a plurality of first storage chambers 261 and second storage chambers 262, respectively, and an outlet flow path 32A connecting the first storage chambers 261 and second storage chambers 262 to the outlet port 36. Thus, by connecting the medical bag 12 to each of the first inlet tubes 161 and second inlet tubes 162, the collection target M can be stored in each of the first storage chambers 261 and second storage chambers 262 from the first inlet tubes 161 and second inlet tubes 162.

[0077] 9, the collection kit 10B according to the third embodiment includes an inflow tube 16B and a collection bag 18B. The collection bag 18B includes an inflow passage 28B connected downstream of the inflow tube 16B, and an outflow passage 32A connecting the first storage chamber 261 and the second storage chamber 262 with the outflow port 36. Note that the same reference numerals are used for components similar to those of the collection kit 10A according to the second embodiment, and detailed descriptions of the same components will be omitted.

[0078] The inflow channel 28B has a common channel 72, and a first branch channel 741 and a second branch channel 742 that branch off from the common channel 72 and are connected to the first storage chamber 261 and the second storage chamber 262, respectively.

[0079] The common flow path 72 is disposed at the center in the width direction of the collection bag 18B. The common flow path 72 extends in the vertical direction from the upper side 191 to the lower side 192 of the collection bag 18B.

[0080] The first branch flow path 741 and the second branch flow path 742 are connected to the downstream end of the common flow path 72. The first branch flow path 741 is provided in the first region 18L of the collection bag 18B. The first branch flow path 741 has a first folded portion 761 that extends widthwise from the common flow path 72 and then folded back upward. The first folded portion 761 is connected to a lower portion of the first storage chamber 261. The second branch flow path 742 is provided in the second region 18R of the collection bag 18B. The second branch flow path 742 has a second folded portion 762 that extends widthwise from the common flow path 72 and then folded back upward. The second folded portion 762 is connected to a lower portion of the second storage chamber 262. A first inlet-side blocking member 781 is provided in the first branch flow path 741. The first inlet-side blocking member 781 can block communication between the inlet tube 16B and the first storage chamber 261. A second inlet side blocking member 782 is provided in the second branch flow path 742. The second inlet side blocking member 782 can block communication between the inlet tube 16B and the second storage chamber 262.

[0081] Next, a collection method for separating the collection target M into the first sampling container 141 and the second sampling container 142 using the collection kit 10B will be described.

[0082] First, the medical bag 12 is connected to the inflow tube 16B. At this time, the first inflow side blocking member 781 is opened to communicate the first storage chamber 261 with the inflow tube 16B. The second inflow side blocking member 782 is opened to communicate the second storage chamber 262 with the inflow tube 16B. Gravity causes the collection target M to flow out of the medical bag 12 and move through the inflow tube 16B, the common flow path 72 of the inflow flow path 28B, the first branch flow path 741, and the second branch flow path 742 to the first storage chamber 261 and the second storage chamber 262. The collection target M that has moved from the common flow path 72 to the first branch flow path 741 flows into the first storage chamber 261. The collection target M that has moved from the common flow path 72 to the second branch flow path 742 flows into the second storage chamber 262. As the collection target M reaches and flows into the first exhaust section 381 and the second exhaust section 382, ​​the first storage chamber 261 and the second storage chamber 262 become filled.

[0083] When collecting the object M from the first storage chamber 261 into the first sampling container 141, the first inlet-side closing member 781 is closed and the first sampling container 141 is connected to the adapter 20. The operator bends the plug of the connecting member 46 to break the plug and open the outlet flow path 32A. The operator then releases the state in which the first closing member 481 has closed the outlet flow path 32A. The object M flows from the first storage chamber 261 into the first sampling container 141. When collecting the object M from the second storage chamber 262 into the second sampling container 142, the second inlet-side closing member 782 is closed and the second sampling container 142 is connected to the adapter 20. The operator releases the state in which the second closing member 482 has closed the outlet flow path 32A. The object M flows from the second storage chamber 262 into the second sampling container 142.

[0084] The third embodiment has the following advantages.

[0085] 9, the collection bag 18B includes a common flow path 72 connected downstream of the inflow tube 16B, a first branch flow path 741 and a second branch flow path 742 branching from the common flow path 72 and connected to the plurality of storage chambers 26, respectively, and an outflow flow path 32A connecting the first storage chamber 261 and the second storage chamber 262 to the outflow port 36. This allows the collection objects M to be stored in the plurality of first storage chambers 261 and second storage chambers 262 through the single common flow path 72.

[0086] 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 sequentially collecting samples from 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, one outflow port for transferring the samples from the plurality of storage chambers to each of the plurality of sampling containers, and an exhaust section for exhausting the air inside the plurality of storage chambers.

2. A collection kit according to claim 1, comprising a connecting flow path provided between a plurality of said storage chambers and connecting adjacent storage chambers to each other, the inflow tube being connected to one of the plurality of said storage chambers, and an outflow flow path connected to the outflow port being connected to one of the plurality of said storage chambers or to another storage chamber.

3. A collection kit according to claim 1, comprising: a plurality of inlet tubes respectively connected to a plurality of said storage chambers; and an outlet flow path connecting the plurality of said storage chambers with the outlet port.

4. A collection kit according to claim 1, wherein the collection bag comprises: a common flow path connected downstream of the inlet tube; a plurality of branch flow paths branching off from the common flow path and respectively connected to a plurality of the storage chambers; and an outlet flow path connecting the plurality of storage chambers to the outlet port.

5. A collection kit according to any one of claims 1 to 4, wherein an adaptor is connected to the outlet port, to which a plurality of the sampling containers are sequentially attached.

Citation Information

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