Collection kit

CN122270245APending Publication Date: 2026-06-23TERUMO KK
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Patent Information

Application Number
CN202480075065.4
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Priority Date
2023-11-28
Filing Date
2024-11-26
Publication Date
2026-06-23

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Abstract

The collection kit (10A) has: an inflow pipe (12); a plurality of inflow ports (a first inflow port (11a) and a second inflow port (11b)) connected downstream of the inflow pipe (12); a collection bag (14A) having a plurality of receiving chambers (a first receiving chamber (26) and a second receiving chamber (28)); a plurality of outflow ports (a first outflow port (15) and a second outflow port (17)) respectively connected to the plurality of receiving chambers; and a plurality of exhaust sections (a first exhaust section (61) and a second exhaust section (62)) respectively connected to the plurality of receiving chambers.
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Description

Technical Field

[0001] This invention relates to a collection kit for transferring a collection object (mainly liquid medicine) contained in a medical bag to multiple sampling containers. Background Technology

[0002] Blood products include red blood cell preparations, plasma preparations, platelet preparations, and whole blood preparations. To ensure safety, small amounts of blood products are sometimes collected for culture testing. In culture testing, the sample is collected into a culture bottle (sampling container) and placed in an environment suitable for bacterial growth to detect the presence of pathogens.

[0003] The following describes the procedure for transferring platelet preparations from a medical bag containing platelet preparations (hereinafter referred to as a platelet bag) to two culture flasks, using a medical bag containing platelet preparations as an example.

[0004] A small collection bag is attached to the platelet bag, allowing a portion of the platelet preparation in the platelet bag to be 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 predetermined amount of platelet preparation is transferred from the collection bag to the sample collection tube, using the scale on the sample collection tube as a reference. Then, two culture flasks are sequentially connected to the sample collection tube, and a predetermined amount of platelet preparation is transferred to each flask. One culture flask is for anaerobic culture, and the other is for aerobic culture.

[0005] For example, U.S. Patent No. 8,777,921 discloses a collection kit for collecting samples from medical bags. Existing technical documents Patent documents

[0006] Patent Document 1: US Patent No. 8777921 Summary of the Invention

[0007] In order to further improve the safety of blood products, the culture and testing of all blood products is being explored. Therefore, there is a need to improve the efficiency of blood product culture and testing. Furthermore, when performing culture and testing of all products, it is desirable to have a simpler and lower-cost apparatus for dispensing blood products into culture bottles. Additionally, it is desirable to be able to collect a predetermined amount of the sample into multiple sampling containers separately.

[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 a collection object contained in a medical bag into a plurality of sampling containers, wherein the collection kit has: at least one inlet tube connected to the medical bag; a plurality of inlet ports connected downstream of the at least one inlet tube; a collection bag connected downstream of the plurality of inlet ports, the collection bag being formed by overlapping and welding two flexible sheets, with a plurality of receiving chambers for receiving the collection object formed between the two flexible sheets; a plurality of outlet ports respectively connected to the plurality of receiving chambers, the plurality of outlet ports respectively transferring the collection object from the plurality of receiving chambers toward the plurality of sampling containers; and a plurality of exhaust sections respectively connected to the plurality of receiving chambers, the plurality of exhaust sections being used to exhaust air inside the plurality of receiving chambers to the outside of the collection bag, wherein the number of the plurality of inlet ports, the number of the plurality of receiving chambers, and the number of the plurality of outlet ports are the same as each other.

[0010] Because the collection bag is constructed using two flexible sheets integrally formed, the collection kit can be manufactured at low cost. The collection bag has multiple compartments that can store a specified amount (necessary amount) of the object to be collected, thereby enabling the collection of a specified amount of the object to be collected into multiple sampling containers.

[0011] (2) In the acquisition kit described in (1) above, it may also be a plurality of connectors having a downstream connection to the plurality of outflow ports and being able to connect to the plurality of sampling containers.

[0012] According to this configuration, the acquisition kit has multiple connectors in its initial state, which saves the amount of work required to connect multiple connectors when using the acquisition kit, and enables efficient acquisition operations.

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

[0014] According to this configuration, when the object to be collected is transferred from the medical bag to the collection bag, the connection and separation between the medical bag and the inflow tube are performed only once, thereby enabling efficient collection operations.

[0015] (4) In the acquisition kit described in (1) or (2) above, at least one of the inflow pipes may include multiple inflow pipes that are respectively connected to multiple inflow ports.

[0016] This configuration also allows for the transfer of the collected material from the medical bag to multiple compartments of the collection bag, and the storage of the collected material in multiple compartments in a specified quantity.

[0017] (5) In the collection kit described in (4) above, the collection bag may also have multiple segments, each having multiple containment chambers, and the multiple segments may be separable from each other.

[0018] Because the collection bag can be divided into multiple segments, when you want to collect the object into a number of sampling containers that are fewer than the number of containment chambers, you can use only the required number of segments.

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

[0020] According to the sampling kit of the present invention, since the sampling bag is constructed by integrally forming two flexible sheets, the sampling kit can be manufactured at low cost. The sampling bag has multiple compartments that can store a predetermined amount (necessary amount) of the sample, thereby enabling the sampling of a predetermined amount of the sample to be collected into multiple sampling containers respectively. Attached Figure Description

[0021] Figure 1 This is an overall diagram of the acquisition kit according to the first embodiment of the present invention. Figure 2 This is a diagram showing the state of the object being collected in the collection kit of the first embodiment of the present invention. Figure 3 This is a diagram showing the acquisition kit of the first embodiment of the present invention connected to a culture flask. Figure 4 This is an overall diagram of the acquisition kit according to the second embodiment of the present invention. Figure 5 This is a diagram showing the state of the object being collected being placed in the first receiving chamber of the collection kit according to the second embodiment of the present invention. Figure 6 This diagram shows the state of the object being collected into the first and second accommodating chambers of the collection kit according to the second embodiment of the present invention. Figure 7 This is a diagram showing the acquisition kit of the second embodiment of the present invention connected to a culture flask. Figure 8 This is a diagram illustrating another method of using the acquisition kit according to the second embodiment of the present invention. Detailed Implementation

[0022] Figures 1-3 The collection kit 10A shown in this embodiment is for dispensing blood preparations, which are the objects of collection, into sampling containers 51 and 52 (see reference 10A). Figure 3For transfer and use. The sample may be a blood product such as platelet preparations. The sample may also be a pharmaceutical product other than a blood product. The sample may also be a liquid sample other than a pharmaceutical product. Medical bag 56 ( Figure 2 It can also be a blood bag system, used to centrifuge blood containing multiple components into multiple components with different specific gravities (e.g., three components: a light specific gravity component, a medium specific gravity component, and a heavy specific gravity component, or two components: a light specific gravity component and a heavy specific gravity component), and to store and preserve each component separately in different bags. In this case, the collection kit 10A can also be connected to the blood bag system. Typically, the collection kit 10A enables... Figures 1-3 The posture used should correspond to the vertical direction. Therefore, in the following description, for the acquisition kit 10A, the following will be... Figures 1-3 The vertical direction (V direction) in the text is called the "vertical direction". Figures 1-3 The left-right direction (W direction) is referred to as the "width direction". This definition of direction applies to the acquisition kit 10B described later. Figures 4-7 The same applies to ( ).

[0023] The collection kit 10A is used, for example, in blood centers and other institutions that manufacture blood products, in culture tests to confirm the safety of the blood products. In this case, Figure 3 The sampling containers 51 and 52 shown are culture flasks.

[0024] The culture test includes both anaerobic and aerobic bacterial cultures. Therefore, for the culture test, two bottles are used: sampling container 51 (hereinafter referred to as "first sampling container 51") for anaerobic culture and sampling container 52 (hereinafter referred to as "second sampling container 52") for aerobic culture. The collection kit 10A is used to collect liquid sample (platelet preparation) and dispense it in prescribed amounts into the two sampling containers 51 and 52 respectively.

[0025] Hereinafter, an example of using a platelet preparation as a blood preparation will be described in this embodiment, but the blood preparation collected by the collection kit 10A may also be a red blood cell preparation, a plasma preparation or a whole blood preparation.

[0026] like Figure 1 As shown, the collection kit 10A has an inflow pipe 12, multiple inflow ports (first inflow port 11a and second inflow port 11b), a collection bag 14A, multiple outflow ports (first outflow port 15 and second outflow port 17), and multiple connectors (first connector 21a and second connector 21b). The collection kit 10A also has multiple exhaust sections (first exhaust section 61 and second exhaust section 62).

[0027] The inflow tube 12 is, for example, a translucent medical tube made of a thermoplastic resin such as vinyl chloride resin. The inflow tube 12 can be connected to or disconnected from other medical tubes without exposing its interior to external air, for example, through aseptic joining devices and tube sealing devices. The inflow tube 12 has an upstream end 12a and a plurality of downstream ends 12b. The upstream end 12a of the inflow tube 12 is fused and sealed in its initial state. In the first embodiment, the number of downstream ends 12b of the inflow tube 12 is two. The inflow tube 12 has a connection to a medical bag 56 (see reference). Figure 2 The collection bag 14A has a common portion 120 and multiple branch portions (first branch portion 121 and second branch portion 122) branching from the common portion 120. The inflow pipe 12 is not present inside the collection bag 14A. That is, the inflow pipe 12 is not formed between the flexible sheets 22a and 22b and is disposed on the outside of the collection bag 14A.

[0028] The first inlet port 11a and the second inlet port 11b are inlets for introducing the collected object from the inlet pipe 12 into the collection bag 14A. The first inlet port 11a and the second inlet port 11b protrude upwards from the upper edge 141 of the collection bag 14A. The downstream end 12b of the first branch 121 is connected to the first inlet port 11a. The downstream end 12b of the second branch 122 is connected to the second inlet port 11b.

[0029] The collection bag 14A has two flexible sheets 22a and 22b that overlap along the thickness direction. The two flexible sheets 22a and 22b are joined together by welding to each other in multiple welded sections. The sheet portion 22 formed by the two flexible sheets 22a and 22b is rectangular. The collection bag 14A includes multiple inflow paths (first inflow path 31 and second inflow path 32), multiple receiving chambers (first receiving chamber 26 and second receiving chamber 28), and multiple outflow paths (first outflow path 34 and second outflow path 36). The multiple inflow paths, multiple receiving chambers, and multiple outflow paths are divided by the welded sections.

[0030] The collection bag 14A may also have three or more inflow paths, three or more receiving chambers, and three or more outflow paths. The number of inflow paths, the number of receiving chambers, and the number of outflow paths are the same. Multiple inflow paths and multiple branches are in a corresponding relationship (one branch is provided for each inflow path), so when the collection bag 14A has three or more inflow paths, the number of branches of the inflow pipe 12 is the same as the number of inflow paths.

[0031] In the initial state of the acquisition kit 10A, the first inflow path 31, the second inflow path 32, the first receiving chamber 26, the second receiving chamber 28, the first outflow path 34, and the second outflow path 36 bulge outwards in the thickness direction of the acquisition bag 14A. Therefore, the two flexible sheets 22a and 22b are separated from each other in the thickness direction in each of the first inflow path 31, the second inflow path 32, the first receiving chamber 26, the second receiving chamber 28, the first outflow path 34, and the second outflow path 36. Furthermore, the thickness direction of the acquisition bag 14A is orthogonal to the vertical direction (V direction) and the width direction (W direction).

[0032] The first inflow path 31 connects the first inflow port 11a to the first receiving chamber 26 of the collection bag 14A. The first inflow path 31 is connected to the upper end of the first receiving chamber 26 of the collection bag 14A. The second inflow path 32 connects the second inflow port 11b to the second receiving chamber 28 of the collection bag 14A. The second inflow path 32 is connected to the upper end of the second receiving chamber 28 of the collection bag 14A. Furthermore, as... Figure 1 As shown by the imaginary lines, the first inflow path 31 can also be connected to the lower part 262 of the first receiving chamber 26, and the second inflow path 32 can also be connected to the lower part 282 of the second receiving chamber 28.

[0033] The first receiving chamber 26 is a receiving area for temporarily storing platelet preparations during transfer to the first sampling container 51. In the initial state of the collection kit 10A, the first receiving chamber 26 bulges out in the thickness direction of the collection bag 14A, and air is contained within the first receiving chamber 26. The first receiving chamber 26 has a volume that can hold a predetermined amount (e.g., about 8 mL to about 10 mL) of platelet preparations.

[0034] The upper part 261 of the first receiving chamber 26 is a roughly triangular shape whose width gradually decreases upwards. A first inflow passage 31 is connected to the upper end of the upper part 261. The lower part 262 of the first receiving chamber 26 is a roughly triangular shape whose width gradually decreases downwards. The middle part 263 of the first receiving chamber 26 is located between the upper part 261 and the lower part 262, and its width is constant in the vertical direction.

[0035] The first outflow path 34 is connected to the lower end of the first receiving chamber 26 (the lower end of the lower part 262). The first outflow path 34 extends downward from the lower end of the first receiving chamber 26. The first outflow path 34 is a flow path for transferring the sampled object toward the first sampling container 51.

[0036] The second receiving chamber 28 is a storage area for temporarily storing platelet preparations during transfer to the second sampling container 52. In the initial state of the collection kit 10A, the second receiving chamber 28 bulges out in the thickness direction of the collection bag 14A, and air is present within the second receiving chamber 28. The second receiving chamber 28 has the same shape as the first receiving chamber 26 and a volume capable of holding a predetermined amount of platelet preparation (e.g., about 8 mL to about 10 mL) similar to that of the first receiving chamber 26. Furthermore, the volumes of the first receiving chamber 26 and the second receiving chamber 28 may be different from each other.

[0037] The upper part 281 of the second receiving chamber 28 is a roughly triangular shape whose width gradually decreases upwards. The lower part 282 of the second receiving chamber 28 is a roughly triangular shape whose width gradually decreases downwards. The middle part 283 of the second receiving chamber 28 is located between the upper part 281 and the lower part 282, and its width is constant in the vertical direction.

[0038] The second outflow path 36 is connected to the lower end of the second receiving chamber 28. The second outflow path 36 extends downward from the lower end of the second receiving chamber 28. The second outflow path 36 is a flow path for transferring the sampled object toward the second sampling container 52.

[0039] When the sample material flows into the first receiving chamber 26, the first exhaust section 61 discharges air from the first receiving chamber 26 to the outside of the collection bag 14A. The collection bag 14A has a first exhaust flow path 41 connected to the upper part 261 of the first receiving chamber 26. The first exhaust flow path 41 is formed between the flexible sheets 22a and 22b. The first exhaust section 61 is connected to the first exhaust flow path 41. The first exhaust section 61 has a filter 64.

[0040] The filter 64 has the function of allowing gas to pass through while preventing liquid from passing through. In the first embodiment, the filter 64 is a hydrophilic filter 64a. The hydrophilic filter 64a allows gas to pass through before being wetted by liquid and prevents gas from passing through after being wetted by liquid. When the first receiving chamber 26 is filled with the object to be collected, and the hydrophilic filter 64a comes into contact with the object to be collected, the pores of the hydrophilic filter 64a are blocked by the liquid constituting the object to be collected, and then the first exhaust section 61 prevents the passage of both gas and liquid.

[0041] When the sample material flows into the second receiving chamber 28, the second exhaust section 62 discharges air from the second receiving chamber 28 to the outside of the collection bag 14A. The collection bag 14A has a second exhaust flow path 42 connected to the upper part 281 of the second receiving chamber 28. The second exhaust flow path 42 is formed between flexible sheets 22a and 22b. The second exhaust section 62 is connected to the second exhaust flow path 42. The second exhaust section 62 has a filter 64 (hydrophilic filter 64a).

[0042] Furthermore, multiple receiving chambers and multiple exhaust sections are arranged in a corresponding relationship (one exhaust section for each receiving chamber), so that when the collection bag 14A has more than three receiving chambers, the number of exhaust sections is the same as the number of receiving chambers. Alternatively, the filter 64 may be disposed on the wall forming the first receiving chamber 26, which is also an alternative to the first exhaust section 61. Similarly, the filter 64 may be disposed on the wall forming the second receiving chamber 28, which is also an alternative to the second exhaust section 62.

[0043] exist Figure 1 In this configuration, the first outflow port 15 is connected to the first outflow path 34. The first outflow port 15 is used to allow flow from the first receiving chamber 26 toward the first sampling container 51 (see reference). Figure 3 A flow path component for transferring the collected object. A first connector 21a is connected to the first outflow port 15. The first outflow port 15 protrudes from the lower side 142 of the collection bag 14A.

[0044] The first outflow port 15 functions as the first sealing component 16. In its initial state, the first sealing component 16 seals the first outflow path 34, preventing fluid from passing between the first receiving chamber 26 and the first connector 21a. The first sealing component 16 is a cylindrical component with a breakable plug inside. In its initial state, if the plug is bent, it can break, opening the internal flow path.

[0045] The second outflow port 17 is connected to the second outflow path 36. The second outflow port 17 is used for flow from the second receiving chamber 28 toward the second sampling container 52 (see reference). Figure 3 The flow path component for transferring the collected object. A second connector 21b is connected to the second outflow port 17. The second outflow port 17 protrudes from the lower side 142 of the collection bag 14A.

[0046] The second outflow port 17 functions as the second sealing component 18. The second sealing component 18 is the same component as the first sealing component 16, which seals the second outflow path 36 in the initial state to prevent fluid from passing between the second receiving chamber 28 and the second connector 21b.

[0047] The first connector 21a has a receiving tube 80 capable of accommodating the neck of the first sampling container 51, a tubular needle portion 82 disposed inside the receiving tube 80, and a rubber cap 84 covering the needle portion 82. The receiving tube 80 has a cap 86 that can be opened and closed. Alternatively, a peeling strip may be used instead of the cap 86.

[0048] The needle 82 can puncture the rubber plug 93 of the first sampling container 51 (see reference). Figure 3If the needle 82 of the first connector 21a penetrates the rubber plug 93 of the first sampling container 51 and the first sealing member 16 is open, then the first sampling container 51 and the first receiving chamber 26 are connected. When the needle 82 punctures the rubber plug 93 of the first sampling container 51, the rubber cap 84 is pressed in towards the base end, causing the needle 82 to penetrate the rubber cap 84. When the needle 82 is pulled out from the rubber plug 93 of the first sampling container 51, the rubber cap 84 extends according to its elastic restoring force and covers the needle 82 again.

[0049] The second connector 21b has the same configuration as the first connector 21a. If the needle 82 of the second connector 21b penetrates the rubber plug 93 of the second sampling container 52 and the second sealing member 18 is opened, then the second sampling container 52 and the second receiving chamber 28 are connected.

[0050] Furthermore, when the collection bag 14A has three or more receiving chambers, the collection kit 10A has three or more outflow ports and three or more connectors corresponding to each receiving chamber.

[0051] Alternatively, in the initial state of the acquisition kit 10A, the first connector 21a and the second connector 21b are not provided with the acquisition kit 10A. In this case, when the acquisition kit 10A is used, the first connector 21a and the second connector 21b are connected relative to the acquisition kit 10A. For example, the first connector 21a has a locking claw and a connecting pin, and the lower part of the first outlet port 15 has a locking groove and a rubber plug. By inserting the connecting pin into the rubber plug, the locking claw engages with the locking groove, thereby connecting the first connector 21a and the first outlet port 15. The second connector 21b also has the same connection structure as the first connector 21a.

[0052] The collection kit 10A, configured as described above, is used as follows. In the first embodiment, taking the case where the object to be collected is a platelet preparation as an example, the method of using the collection kit 10A to transfer the platelet preparation into two sampling containers 51, 52 (see reference 10A) will be explained. Figure 3 The method for collecting sub-injections.

[0053] like Figure 2 As shown, a platelet bag 57, which contains the sample to be collected, is connected to a collection kit 10A in one manner. The platelet bag 57 has a connecting tube 58. The tube 58 is connected to an inflow tube 12. The tube 58 is connected to the inflow tube 12 using a sterile connection device so as not to come into contact with outside air.

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

[0055] Platelet preparations flow out of platelet bag 57 by gravity and into the common portion 120 of inflow tube 12. At the downstream end of the common portion 120, the platelet preparations are split via a first branch 121 and a second branch 122 and flow into collection bag 14A. Therefore, platelet preparations passing through the first branch 121 flow into collection bag 14A via the first inflow port 11a, and platelet preparations passing through the second branch 122 flow into collection bag 14A via the second inflow port 11b.

[0056] Platelet preparations flowing into collection bag 14A via first inlet port 11a flow into first receiving chamber 26 via first inlet flow path 31. The platelet preparations are stored in first receiving chamber 26, and the liquid level of the platelet preparations in first receiving chamber 26 rises. Air inside first receiving chamber 26 is pushed up by the platelet preparations and discharged from first exhaust section 61 via first exhaust flow path 41.

[0057] When the first receiving chamber 26 is filled with platelet preparation, and the filter 64 of the first exhaust section 61 comes into contact with the platelet preparation and becomes wetted, the filter 64 becomes clogged, and the inflow of platelet preparation into the first receiving chamber 26 stops. Thus, the introduction of platelet preparation into the first receiving chamber 26 is completed. The first receiving chamber 26 contains a predetermined amount (e.g., 8 mL to 10 mL) of platelet preparation.

[0058] On the other hand, the platelet preparation flowing into the collection bag 14A via the second inlet port 11b flows into the second receiving chamber 28 via the second inlet flow path 32. The platelet preparation is stored in the second receiving chamber 28, and the liquid level of the platelet preparation in the second receiving chamber 28 rises. The air inside the second receiving chamber 28 is pushed up and discharged from the second exhaust section 62 via the second exhaust flow path 42.

[0059] When the second receiving chamber 28 is filled with platelet preparation, and the filter 64 of the second exhaust section 62 comes into contact with the platelet preparation and becomes wetted, the filter 64 becomes clogged, and the inflow of platelet preparation into the second receiving chamber 28 stops. Thus, the introduction of platelet preparation into the second receiving chamber 28 is completed. The second receiving chamber 28 contains a predetermined amount (e.g., 8 mL to 10 mL) of platelet preparation.

[0060] Then, the platelet bag 57 is separated from the inflow tube 12 using a tube sealing device (high-frequency sealing device or ultrasonic sealing device). The tube sealing device seals the upstream end 12a of the inflow tube 12 by welding while simultaneously separating the inflow tube 12 from the tube 58 of the platelet bag 57. The separation of the inflow tube 12 from the tube 58 is carried out in a manner that prevents the internal flow path from being exposed to external air. The separated platelet bag 57 is stored until the culture test is completed, and then made available for use.

[0061] On the other hand, the collection kit 10A, filled with platelet preparations, was moved into the clean bench. Next, as... Figure 3 As shown, operations are performed to transfer platelet preparations from collection kit 10A to the first sampling container 51 and the second sampling container 52 (connection process and activation process).

[0062] In the connection process, the first sampling container 51 is connected to the first connector 21a, and the second sampling container 52 is connected to the second connector 21b. The needle 82 of the first connector 21a passes through the rubber plug 93 of the first sampling container 51, and the needle 82 of the second connector 21b passes through the rubber plug 93 of the second sampling container 52.

[0063] Then, if the first sealing component 16 is opened during the opening process, the platelet preparation in the first receiving chamber 26 is drawn in by the negative pressure of the first sampling container 51 and flows into the first sampling container 51 via the first outflow path 34 and the first outflow port 15 (the first sealing component 16). Thus, a predetermined amount of platelet preparation is introduced into the first sampling container 51. Furthermore, if the second sealing component 18 is opened during the opening process, the platelet preparation in the second receiving chamber 28 is drawn in by the negative pressure of the second sampling container 52 and flows into the second sampling container 52 via the second outflow path 36 and the second outflow port 17 (the second sealing component 18). Thus, a predetermined amount of platelet preparation is introduced into the second sampling container 52.

[0064] The result is that approximately the entire amount of the platelet preparation stored in the first receiving chamber 26 is transferred to the first sampling container 51, and approximately the entire amount of the platelet preparation stored in the second receiving chamber 28 is transferred to the second sampling container 52.

[0065] Through the above procedures, the collection of the target material (platelet preparation) using the collection kit 10A is completed.

[0066] Furthermore, in the collection of objects using the collection kit 10A, a clamp (collection kit clamp) for connecting the collection kit 10A to the first sampling container 51 and the second sampling container 52 can also be used. The collection kit clamp, for example, includes a kit holding part for holding the collection kit 10A, a lifting mechanism for displacing the kit holding part in the vertical direction, and a bottle holding part for holding the first sampling container 51 and the second sampling container 52. By lowering the kit holding part holding the collection kit 10A, the collection kit 10A can be connected to the first sampling container 51 and the second sampling container 52. Alternatively, instead of the lifting mechanism for displacing the kit holding part in the vertical direction, a lifting mechanism for raising and lowering the bottle holding part can be provided.

[0067] The first implementation method has the following effects.

[0068] The sampling kit 10A is constructed by integrally forming the sampling bag 14A using two flexible sheets 22a and 22b, thereby enabling low-cost manufacturing. Furthermore, the number of times the tubes are joined and separated is minimized, resulting in excellent operational efficiency. Moreover, it eliminates the need for visual measurement and sampling of the object according to scale lines, simplifying the operation and reducing measurement errors.

[0069] The collection bag 14A has a first receiving chamber 26 and a second receiving chamber 28, which can store a predetermined amount (necessary amount) of the object to be collected, thereby enabling the collection of a predetermined amount of the object to be collected into the first sampling container 51 and the second sampling container 52 respectively. Therefore, the collection kit 10A can suppress deviations in the amount of object to be collected introduced into the first sampling container 51 and the second sampling container 52.

[0070] In the collection kit 10A, the number of multiple inflow ports, the number of multiple receiving chambers, and the number of multiple outflow ports are all the same. Specifically, in the first embodiment, the collection kit 10A has two inflow ports (first inflow port 11a and second inflow port 11b), two receiving chambers (first receiving chamber 26 and second receiving chamber 28), and two outflow ports (first outflow port 15 and second outflow port 17). In this configuration, no connecting flow path is formed within the collection bag 14A to connect the first receiving chamber 26 and the second receiving chamber 28 to each other, thereby avoiding a complex configuration of the collection bag 14A. Furthermore, when the aforementioned connecting flow path is formed, in order to prevent the object to be collected from moving between the first receiving chamber 26 and the second receiving chamber 28, a process of blocking the connecting flow path (blocking process) is required. In contrast, the collection kit 10A has independent first receiving chamber 26 and second receiving chamber 28, thus eliminating the need for the blocking process described above.

[0071] The acquisition kit 10A has multiple connectors (first connector 21a and second connector 21b) in its initial state, which saves the amount of work required to connect multiple connectors when using the acquisition kit 10A and enables efficient acquisition operations.

[0072] The inflow tube 12 has a common portion 120 that connects to the medical bag 56, and multiple branches (first branch 121 and second branch 122) that branch off from the common portion 120 and connect to multiple inflow ports respectively. With this configuration, when the object to be collected is transferred from the medical bag 56 to the collection bag 14A, the connection and separation between the medical bag 56 and the inflow tube 12 are performed only once, thereby enabling efficient collection operations.

[0073] Next, refer to Figures 4-8 This describes the acquisition kit 10B of the second embodiment.

[0074] The acquisition kit 10B of the second embodiment has multiple inflow pipes connected to multiple inflow ports respectively. The second embodiment has two inflow pipes, hereinafter referred to as "first inflow pipe 91" and "second inflow pipe 92". The upstream end 91a of the first inflow pipe 91 is fused and sealed in the initial state. The downstream end 91b of the first inflow pipe 91 is connected to the first inflow port 11a. The upstream end 92a of the second inflow pipe 92 is fused and sealed in the initial state. The downstream end 92b of the second inflow pipe 92 is connected to the second inflow port 11b.

[0075] The collection bag 14B of the collection kit 10B differs from others at points having a vulnerable part 66 and multiple segments distinguished by the vulnerable part 66. Figure 1 The collection bag 14A shown is shown. Figure 4 The collection bag 14B shown contains two segments, hereinafter referred to as "segment 1 S1" and "segment 2 S2". Segment 1 S1 has a first receiving chamber 26. Segment 2 S2 has a second receiving chamber 28.

[0076] The vulnerable portion 66 extends vertically from the upper edge 141 to the lower edge 142 of the collection bag 14B. Therefore, the vulnerable portion 66 divides the collection bag 14B into left and right regions. The vulnerable portion 66 is a structural part that allows the first segment S1 and the second segment S2 to be separated from each other. The vulnerable portion 66 is a part that is weaker and more prone to breakage compared to other structural parts of the collection bag 14B. In the second embodiment, the vulnerable portion 66 is a perforation 67. The vulnerable portion 66 can also be a thin portion.

[0077] The collection kit 10B, constructed as described above, is used as follows. In the second embodiment, taking the case where the object of collection is a platelet preparation as an example, the use of the collection kit 10B to transfer the platelet preparation into two sampling containers 51, 52 (see reference 10B) will be explained. Figure 7 The method for collecting sub-injections.

[0078] like Figure 5 As shown, the tube 58 of the platelet bag 57 is connected to the first inflow tube 91 of the collection kit 10B. The tube 58 is connected to the first inflow tube 91 using a sterile connection device without contact with outside air.

[0079] Next, platelet preparations are introduced into the first receiving chamber 26 of the collection bag 14B. In this process, the platelet bag 57 is positioned above the collection bag 14B. The first sealing component 16 of the collection kit 10B is kept in a blocked state.

[0080] Platelet preparations flow out of platelet bag 57 by gravity, through first inlet tube 91 and first inlet port 11a into first inlet flow path 31, and into first receiving chamber 26. Then, with reference... Figure 2 Similarly, in the collection method described, air is discharged from the first containment chamber 26 via the first exhaust section 61, and the first containment chamber 26 is filled with platelet preparations.

[0081] Then, the platelet bag 57 is separated from the first inflow tube 91 by a tube sealing device (high frequency sealing device or ultrasonic sealing device).

[0082] Next, as Figure 6 As shown, tube 58 of platelet bag 57 is connected to second inflow tube 92. Tube 58 is connected to second inflow tube 92 using a sterile connection device so as not to come into contact with outside air.

[0083] Next, platelet preparations are introduced into the second receiving chamber 28 of the collection bag 14B. In this process, the platelet bag 57 is positioned above the collection bag 14B. The second sealing component 18 of the collection kit 10B is maintained in a blocked state.

[0084] Platelet preparations flow out of platelet bag 57 by gravity, through second inlet tube 92 and second inlet port 11b into second inlet flow path 32, and into second receiving chamber 28. Then, with reference... Figure 2 Similarly, in the collection method described, air is discharged from the second containment chamber 28 via the second exhaust section 62, and the second containment chamber 28 is filled with platelet preparations.

[0085] Then, the platelet bag 57 is separated from the second inflow tube 92 by a tube sealing device (high-frequency sealing device or ultrasonic sealing device). The separated platelet bag 57 is stored until the culture test is completed, and then made available for use. Alternatively, the process can be reversed, with the platelet preparation being introduced into the second receiving chamber 28 first, and then the platelet preparation being introduced into the first receiving chamber 26.

[0086] On the other hand, the collection kit 10B, filled with platelet preparations, was moved into the clean bench. Next, as... Figure 7 As shown, operations are performed to transfer platelet preparations from collection kit 10B to the first sampling container 51 and the second sampling container 52 (connection and activation procedures). The connection and activation procedures are similar to those described in the reference... Figure 3 The connection and activation procedures are described in the same way.

[0087] Through the above procedures, the collection of platelet preparations using the collection kit 10B is completed.

[0088] In addition, in the collection of platelet preparations using the collection kit 10B, a clamp (clamp for collection kit) for connecting the collection kit 10B to the first sampling container 51 and the second sampling container 52 can also be used.

[0089] The acquisition kit 10B of the second embodiment has the following effects.

[0090] The collection kit 10B has multiple inflow tubes (first inflow tube 91 and second inflow tube 92) respectively connected to multiple inflow ports (first inflow port 11a and second inflow port 11b). With this configuration, the object to be collected can also be transferred from the medical bag 56 to multiple receiving chambers of the collection bag 14B, and a predetermined amount of the object to be collected can be stored in the multiple receiving chambers.

[0091] The collection bag 14B has multiple segments (segment 1 S1 and segment 2 S2), each having multiple receiving chambers. These segments are separable from each other. Based on this configuration, the collection bag 14B can be divided into multiple segments, thus allowing the use of only the required number of segments when it is desired to collect the object into fewer sampling containers than the number of receiving chambers. For example, after collecting the object into two sampling containers, if another sample is desired for an additional culture experiment, such as... Figure 8 As shown, the first segment S1 is separated from the second segment S2. Then, using only the first segment S1, the object to be collected can be collected.

[0092] In addition, it can also be said that, in Figure 7 After the sample is collected into the collection bag 14B, the first segment S1 is separated from the second segment S2. Specifically, the sample is collected into the first segment S1 of the collection bag 14B before it is separated into the first segment S1 and the second segment S2. Next, the first segment S1 is separated from the second segment S2. Then, a sampling container is connected to the connector (first connector 21a) connected to the first segment S1, and the sample is transferred into the sampling container.

[0093] Regarding the parts common to the first embodiment in the second embodiment, the same or identical functions and effects can be obtained as in the first embodiment.

[0094] Furthermore, the present invention is not limited to the above disclosure and can be configured in various ways without departing from the spirit of the present invention.

Claims

1. A collection kit for collecting samples from a medical bag containing a sample object into multiple sampling containers, wherein, The acquisition kit has the following features: At least one inlet tube connected to the medical bag; A plurality of inflow ports connected downstream of at least one of the inflow pipes; A collection bag connected downstream of the plurality of said inflow ports, the collection bag being formed by overlapping and welding two flexible sheets, with a plurality of receiving chambers formed between the two flexible sheets to accommodate the collection object; Multiple outflow ports are respectively connected to multiple containment chambers, and the multiple outflow ports respectively transfer the collected object from the multiple containment chambers toward the multiple sampling containers; as well as Multiple exhaust units are connected to the multiple chambers respectively, and the multiple exhaust units are used to exhaust the air inside the multiple chambers to the outside of the collection bag. The number of the plurality of inflow ports, the number of the plurality of containment chambers, and the number of the plurality of outflow ports are the same for each other.

2. The acquisition kit according to claim 1, wherein, It has multiple connectors that are respectively connected to the downstream of the multiple outflow ports and can be connected to the multiple sampling containers.

3. The acquisition kit according to claim 1 or 2, wherein, At least one of the inflow tubes has a common portion connected to the medical bag, and a plurality of branch portions branching off from the common portion and connected to the plurality of inflow ports respectively.

4. The acquisition kit according to claim 1 or 2, wherein, At least one of the inflow pipes includes a plurality of inflow pipes respectively connected to a plurality of the plurality of inflow ports.

5. The acquisition kit according to claim 4, wherein, The collection bag has multiple segments, each containing multiple of the aforementioned compartments. The multiple segments can be separated from each other.

6. The acquisition kit according to claim 1 or 2, wherein, At least one of the inflow tubes is disposed on the outside of the collection bag.

Citation Information

Patent Citations

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