Collecting kit
The sampling kit addresses the inefficiency in transferring consistent blood product samples by using an inflexible sampling member with multiple accommodating chambers and an exhaust system, ensuring stable and efficient sample distribution for culture tests.
Patent Information
- Application Number
- PCT/JP2024/041856
- 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
Existing sampling kits for blood products lack efficiency in transferring consistent amounts of samples to multiple culture bottles, which is crucial for ensuring the safety and quality of blood products.
A sampling kit with an inflexible sampling member made of hard material, featuring multiple accommodating portions and chambers, and equipped with inflow and outflow tube portions, and an exhaust system to ensure consistent sample distribution and minimize deformation during use.
The sampling kit ensures that equal amounts of the blood product are transferred to each accommodating chamber, resulting in stable sampling amounts in multiple containers, thereby enhancing the efficiency and reliability of culture tests for blood products.
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Figure JP2024041856_05062025_PF_FP_ABST
Abstract
Description
Collection kit
[0001] The present disclosure relates to a collection kit for transferring a collection target (mainly a liquid medicine) 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 the safety of blood products, a small sample may be taken from the blood product 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. It is also desirable that the amount of blood product divided into culture bottles be approximately the same. In other words, it is desirable that the amount of sample collected in multiple sampling containers be approximately the same.
[0008] The present disclosure aims to solve the above-mentioned problems.
[0009] (1) An aspect of the present disclosure is a collection kit for collecting a collection target contained in a medical bag into a plurality of sampling containers. The collection kit includes an inflow tube to which the medical bag is connected, and a collection member connected downstream of the inflow tube.
[0010] The sampling member has a plurality of storage sections and a plurality of storage chambers formed inside the plurality of storage sections, respectively, for storing the sampled objects. The sampling kit further includes a plurality of outlet pipe sections connected to the plurality of storage chambers and for transporting the sampled objects from the plurality of storage sections to the plurality of sampling containers, respectively, and at least one exhaust section for exhausting air from the plurality of storage chambers to the outside of the sampling member.
[0011] In the above configuration, the collection member is made of an inflexible material. Note that "the collection member is inflexible" means that the collection member has a degree of rigidity that does not substantially deform when the collection target flows into each storage chamber and when the collection target flows out of each storage chamber into the sampling container. In other words, the collection member is made of a hard material and exhibits sufficient strength during use. The elastic modulus of the material of the collection member is, for example, 20 kg / mm 2 For this reason, it is difficult to crush the sampling member with fingers. In this way, the sampling member has so-called shape retention. Therefore, each storage section also has shape retention.
[0012] Therefore, with the above configuration, deformation of each storage section is suppressed when the collection target flows into each storage chamber. As a result, the amount of collection target transferred from the medical bag to each storage chamber is approximately the same. That is, the amount of collection target stored in each storage chamber is constant. Therefore, the amount of collection target collected in each sampling container is stable.
[0013] (2) In the collection kit described in item (1) above, the collection member may have a plurality of inlet pipe sections provided in each of the plurality of storage sections and connected to each of the plurality of storage chambers, and the inlet tube may be connected to the plurality of inlet pipe sections via a branch pipe connected to the downstream end of the inlet tube.
[0014] This configuration allows the sample to be dispensed simultaneously into multiple storage chambers. This further stabilizes the amount of sample collected in the sampling container. Furthermore, the inlet pipe is rigid because it is part of the sampling member. This makes it easy to connect a branch pipe to the inlet pipe.
[0015] (3) In the collection kit described in item (2) above, the multiple inlet pipe sections may each double as the multiple outlet pipe sections, and the branch pipe may have a connection section to which outlet ports that communicate with the multiple outlet pipe sections are connected.
[0016] In this case, the number of tube parts is reduced, and the configuration of the sampling member and sampling kit can be simplified.
[0017] (4) In the collection kit described in item (2) above, the inlet pipe sections and the outlet pipe sections may be separate bodies, and a confluence pipe may be provided that is connected downstream of the outlet pipe sections.
[0018] In this case, one adapter is connected to the confluence pipe and a sampling container is attached to the adapter. After transferring the sample from one of the multiple storage chambers to the sampling container, another sampling container is attached to the adapter and the sample from another of the multiple storage chambers is transferred to this sampling container. As can be seen from the above, this configuration allows the number of adapters to be reduced to one, thereby simplifying the configuration of the sampling kit.
[0019] (5) In the collection kit according to any one of the above items (1) to (4), the collection member may have a tube protection part that covers the inflow tube.
[0020] The inflow tube is surrounded by the tube protector, which prevents the inflow tube from being accidentally crushed. As a result, the inflow tube is prevented from becoming blocked due to crushing. This makes it easy to transfer the sample from the medical bag to each storage chamber.
[0021] (6) In the collection kit described in the above item (5), the tube protection part may be integrally connected to the plurality of storage parts.
[0022] A collection member can be fabricated in which the tube protection part and multiple storage parts are integrally configured, which allows for more efficient construction of the collection member than when the tube protection part and multiple storage parts are fabricated separately and then the multiple storage parts are connected to the tube protection part.
[0023] (7) In the collection kit according to any one of the above items (1) to (6), the material of the collection member may be resin.
[0024] Resin is lightweight, which allows for a lightweight collection kit, and because resin is hard, it is easy to form an inflexible collection member.
[0025] (8) In the collection kit according to the above item (7), the resin may be transparent or translucent.
[0026] The amount of collection target material stored inside the multiple storage sections (storage chambers) can be easily confirmed.
[0027] (9) In the collection kit described in any one of items (1) to (8) above, the exhaust section may have an exhaust tube, and the exhaust tube may have a tube body having an opening and a lid section that can freely open and close the opening of the tube body.
[0028] When transferring the collection target from the medical bag to each storage chamber, the lid can be opened to allow the air in each storage chamber to be exhausted to the outside of the collection member through the opening. After transferring the collection target from the medical bag to each storage chamber, the lid can be closed to maintain the collection target contained in each storage chamber.
[0029] (10) In the collection kit described in the above item (9), the exhaust pipe may have a hydrophilic filter.
[0030] The hydrophilic filter allows air to pass through before it is wet with the liquid sample to be collected, but prevents air from passing through after it is wet with the sample. Therefore, even if the sample overflows from each storage chamber and wets the hydrophilic filter, and the lid is opened to allow air to enter through the opening, the inflow of air into each storage chamber is prevented. This allows the sample to be transferred to a sampling container and used as a sample for an anaerobic culture test.
[0031] (11) The collection kit according to any one of items (1) to (10) above may further include at least one adapter connected downstream of the plurality of outflow pipe sections and connectable to the plurality of sampling containers.
[0032] The adapter allows the storage unit and the sampling container to be easily connected via the outflow pipe. Furthermore, since the sampling kit includes the adapter before use, the operator does not need to connect the adapter to the outflow port each time the sampling kit is used. As a result, sampling can be performed efficiently.
[0033] According to the present disclosure, the amounts of the sample to be collected transferred from the medical bag to the plurality of storage chambers are approximately equal to each other, and therefore the sample amounts of the sample to be collected in each of the plurality of sampling containers are stable.
[0034] FIG. 1 is a schematic perspective view of a collection kit according to a first embodiment. FIG. 2 is a schematic front view of the collection kit according to the first embodiment. FIG. 3 is a schematic front view showing the collection kit of FIG. 2 connected to a medical bag. FIG. 4 is a schematic perspective view of a collection kit jig for transferring a collection target from the collection kit of FIG. 2 to a sampling container. FIG. 5 is a schematic front view of a kit holder constituting the collection kit jig. FIG. 6 is a schematic perspective view of a cover constituting the collection kit jig as viewed from the rear. FIG. 7 is a longitudinal cross-sectional view of a main portion of the collection kit jig. FIG. 8 is a schematic perspective view showing the kit holder lowered from the state shown in FIG. 4. FIG. 9 is a schematic front view showing a state in which a collection target has been transferred from the collection kit to a sampling container. FIG. 10 is a schematic front view of a collection kit according to a second embodiment. FIG. 11 is a schematic front view of a collection kit according to a third embodiment. FIG. 12 is a schematic front view of a collection kit according to a fourth embodiment. FIG. 13 is a schematic front view of a collection kit according to a fifth embodiment. FIG. 14 is a schematic front view of a collection kit according to a sixth embodiment. FIG. 15 is a schematic front view of a collection kit according to the seventh embodiment.
[0035] In the following description, up, down, left, and right correspond to the up, down, left, and right directions shown in Figures 1 and 2. Additionally, the "width direction" refers to the left-right direction in Figures 1 and 2. The "thickness direction" refers to the direction perpendicular to the up-down and width directions. Collection kit 10A shown in Figures 1 and 2 and collection kits 10B to 10G shown in Figures 10 to 15 are typically used in a position where the up-down direction in Figures 1, 2, and 10 to 15 is aligned vertically.
[0036] The collection object of the collection kit 10A shown in FIGS. 1 and 2 is, for example, a blood product such as a platelet product. The collection object may be a pharmaceutical product other than a blood product. The collection object may be a liquid sample other than a pharmaceutical product. The medical bag 80 (see FIG. 3) may be a blood bag system for centrifuging blood containing multiple components into multiple components with different specific gravities (e.g., three components: a light component, a medium component, and a heavy component, or two components: a light component and a heavy component), and storing and storing each component in a separate bag. In this case, the collection kit 10A may be connected to the blood bag system. The same applies to the collection kits 10B to 10G shown in FIGS. 10 to 15.
[0037] In the following, in all of the first to seventh embodiments, an example will be described in which a platelet product M (see FIG. 3) is used as the blood product. Alternatively, the blood product collected by collection kits 10A to 10G may be a red blood cell product, a plasma product, or a whole blood product.
[0038] The collection kits 10A to 10G are used, for example, in a business establishment such as a blood center that produces blood products, for culture tests to confirm the safety of the platelet product M. In the above embodiment, the multiple sampling containers 90 (first sampling container 90a and second sampling container 90b) shown in Figures 4 and 9 are culture bottles.
[0039] The culture test involves testing for anaerobic and aerobic bacterial culture. Therefore, a first sampling container 90a for anaerobic culture and a second sampling container 90b for aerobic culture are used for the culture test. The collection kits 10A-10G are used to collect a liquid sample (platelet preparation M shown in FIG. 3) and dispense a predetermined amount into the first sampling container 90a and the second sampling container 90b.
[0040] (1) Configuration of the Collection Kit First, a collection kit 10A according to a first embodiment will be described with reference to Figures 1 to 3. As shown in Figures 1 and 2, the collection kit 10A includes an inflow tube 12 and a collection member 14A.
[0041] The inflow tube 12 is a transparent or translucent medical tube made of a thermoplastic resin such as polyvinyl chloride resin. The inflow tube 12 can be connected to or disconnected from other medical tubes without exposing the interior to the outside air by using a sterile connection device or a tube sealer. The inflow tube 12 has an upstream end 12u, a midstream portion 12m, and a downstream end 12d. When the collection kit 10A is provided as a product in an unused state, the upstream end 12u is welded and sealed. Hereinafter, the unused state will also be referred to as the "initial state." As shown in FIG. 3 , when transferring a platelet product M contained in a medical bag 80 to the collection member 14A, the medical bag 80 is connected to the upstream end 12u of the inflow tube 12.
[0042] 1 and 2, the midstream section 12m is housed inside the sampling member 14A from the top. The downstream end 12d is exposed below the sampling member 14A and is connected to the sampling member 14A via a branch pipe 16.
[0043] Specifically, the branch pipe 16 has a main connection portion 18a, a first sub-connection portion 18b, and a second sub-connection portion 18c. The downstream end portion 12d of the inflow tube 12 is connected to the main connection portion 18a. The first sub-connection portion 18b is connected to a first inflow pipe portion 32a constituting the sampling member 14A. The second sub-connection portion 18c is connected to a second inflow pipe portion 32b constituting the sampling member 14A. As a result, the inflow tube 12 and the first inflow pipe portion 32a are connected to each other, and the inflow tube 12 and the second inflow pipe portion 32b are also connected to each other. The first inflow pipe portion 32a and the second inflow pipe portion 32b constituting the inflow pipe portion 32 will be described later.
[0044] The collection member 14A has a tube protection part 20 and a plurality of storage parts 22 provided outward in the width direction of the tube protection part 20. As shown in FIG. 1 , the tube protection part 20 is a cylindrical body. The plurality of storage parts 22 are cylindrical bodies with a smaller diameter than the tube protection part 20. The tube protection part 20 and the plurality of storage parts 22 may be cylindrical bodies with a polygonal shape such as a square. Note that the tube protection part 20 is not a required component. The plurality of storage parts 22 may be integrally connected to one another.
[0045] The tube protection part 20 has an insertion hole 24 that extends in the up-down direction. The midstream portion 12m of the inflow tube 12 is inserted into the insertion hole 24. In other words, the midstream portion 12m is covered by the tube protection part 20. As a result, the midstream portion 12m is protected by the tube protection part 20. The upstream end 12u of the inflow tube 12 is exposed above the tube protection part 20 from an upper opening 25a (see FIG. 1 ) formed in the upper surface of the tube protection part 20. The downstream end 12d of the inflow tube 12 is exposed below the tube protection part 20 from a lower opening 25b formed in the lower surface of the tube protection part 20.
[0046] In the illustrated example, the multiple housing portions 22 include a first housing portion 22a and a second housing portion 22b. That is, the number of the multiple housing portions 22 is two. The number of the multiple housing portions 22 may be three or more. The first housing portion 22a and the second housing portion 22b are integrally connected to the tube protection portion 20. Alternatively, the tube protection portion 20, the first housing portion 22a, and the second housing portion 22b may be separate members, and the first housing portion 22a and the second housing portion 22b may be individually connected to the tube protection portion 20.
[0047] The first storage section 22a is hollow and has a first storage chamber 30a therein. The second storage section 22b is also hollow and has a second storage chamber 30b therein. That is, the multiple storage sections 22 each have multiple storage chambers 30.
[0048] As shown in FIG. 9 , the first storage section 22a and the second storage section 22b are storage areas that temporarily store the platelet preparation M to be transferred to the first sampling container 90a and the second sampling container 90b, respectively. The volumes of the first storage chamber 30a and the second storage chamber 30b are each large enough to store, for example, approximately 8 mL to approximately 10 mL of platelet preparation M. The volumes of the first storage chamber 30a and the second storage chamber 30b are, for example, approximately equal to each other. The volumes of the first storage chamber 30a and the second storage chamber 30b may be different from each other. In the initial state of the collection kit 10A, air is present in the first storage chamber 30a and the second storage chamber 30b.
[0049] 1 and 2, the sampling member 14A further includes a first inlet pipe 32a, a first outlet pipe 34a, and a first exhaust pipe 36a. The first inlet pipe 32a and the first outlet pipe 34a are individually connected to the lower part of the first storage section 22a. The first exhaust pipe 36a is connected to the upper part of the first storage section 22a. The first inlet pipe 32a, the first outlet pipe 34a, and the first exhaust pipe 36a each have an inner hole (not shown). The first inlet pipe 32a, the first outlet pipe 34a, and the first exhaust pipe 36a each communicate with the first storage chamber 30a via the respective inner holes.
[0050] The sampling member 14A further includes a second inlet pipe 32b, a second outlet pipe 34b, and a second exhaust pipe 36b. The second inlet pipe 32b and the second outlet pipe 34b are individually connected to the lower part of the second storage unit 22b. The second exhaust pipe 36b is connected to the upper part of the second storage unit 22b. The second inlet pipe 32b, the second outlet pipe 34b, and the second exhaust pipe 36b each have an inner hole (not shown). The second inlet pipe 32b, the second outlet pipe 34b, and the second exhaust pipe 36b each communicate with the second storage chamber 30b via the respective inner holes.
[0051] As can be seen from the above, the sampling member 14A is a single member that integrally includes the tube protector 20, the first storage chamber 30a, the second storage chamber 30b, the first inlet pipe 32a, the second inlet pipe 32b, the first outlet pipe 34a, the second outlet pipe 34b, the first exhaust pipe 36a, and the second exhaust pipe 36b. The sampling member 14A (sampling kit 10A) includes the first outlet pipe 34a and the second outlet pipe 34b as the multiple outlet pipes 34.
[0052] The collection member 14A configured in this manner is inflexible. Specifically, the collection member 14A is rigid enough to not substantially deform when the platelet preparation M is transferred from the medical bag 80 to the first storage chamber 30a, or when the platelet preparation M is transferred from the first storage chamber 30a to the first sampling container 90a. The collection member 14A is also rigid enough to not substantially deform when the platelet preparation M flows into or out of the second storage chamber 30b. The elastic modulus of the material of the collection member 14A is, for example, 20 kg / mm 2For this reason, it is difficult to crush the sampling member 14A with your fingers. As described above, the sampling member 14A is made of a hard material and exhibits sufficient strength during use.
[0053] The collection member 14A is preferably transparent or translucent. In this case, the operator can easily visually check the amount of platelet preparation M contained in the first storage chamber 30a and the second storage chamber 30b. The operator can also easily visually check the amount of platelet preparation M that has flowed out of the first storage chamber 30a and the second storage chamber 30b.
[0054] A suitable example of a material that meets the above conditions is resin. Resin is lightweight, durable, and easy to process, making it suitable for use as the material for collection member 14A. Typical examples of resin include polycarbonate (PC), polypropylene (PP), polystyrene (PS), polyethylene terephthalate (PET), glycol-modified polyethylene terephthalate (PETG), and polyvinyl chloride (PVC). However, collection member 14A may also be made of glass.
[0055] The sampling member 14A further includes an exhaust section 40 for exhausting the air inside the first storage chamber 30a and the second storage chamber 30b to the outside of the sampling member 14A. In the first embodiment, the exhaust section 40 includes a first exhaust section 40a provided on the top of the first storage section 22a and a second exhaust section 40b provided on the top of the second storage section 22b.
[0056] The first exhaust section 40a has a first exhaust tube 42a provided in the first exhaust pipe section 36a. The first exhaust tube 42a has a tube body 44, a lid 46, and a hydrophilic filter 48. The hydrophilic filter 48 is housed inside the tube body 44.
[0057] The hydrophilic filter 48 allows air to pass through before it is wet with the liquid platelet preparation M, but prevents air from passing through after it is wet with the platelet preparation M. Therefore, when the platelet preparation M overflows from the multiple storage chambers 30 and wets the hydrophilic filter 48, atmospheric air (air) is prevented from passing through the hydrophilic filter 48 and flowing into the multiple storage chambers 30. In other words, the hydrophilic filter 48 functions as a resistance to the flow of atmospheric air into the storage chambers 30.
[0058] The upper end of the tube body 44 of the first exhaust tube 42a is an open end having an opening 50. The opening 50 is closed by the lid 46. For example, the tube body 44 and the lid 46 are connected via a hinge (not shown). Therefore, the lid 46 can rotate around the hinge. Alternatively, a threaded portion (not shown) may be formed on the outer circumferential surface of the tube body 44 and the inner circumferential surface of the lid 46. In this case, the threaded portion of the tube body 44 and the threaded portion of the lid 46 are threadedly engaged with each other to attach the lid 46 to the tube body 44. This places the lid 46 in a closed state, preventing atmospheric air from entering the tube body 44. On the other hand, when the threaded portion of the tube body 44 and the threaded portion of the lid 46 are disengaged from each other, the lid 46 is opened, allowing atmospheric air to enter the tube body 44.
[0059] The second exhaust section 40b has a second exhaust tube 42b provided in the second exhaust pipe section 36b. The second exhaust tube 42b has the same configuration as the first exhaust tube 42a. Therefore, a detailed description of the second exhaust tube 42b will be omitted. The first exhaust tube 42a and the second exhaust tube 42b constitute the exhaust tube 42.
[0060] The collection member 14A further includes an adapter 60. The number of adapters 60 is the same as the number of storage sections 22. Therefore, in the illustrated example, the collection kit 10A includes two adapters 60. The two adapters 60 include a first adapter 60a and a second adapter 60b. Note that if the collection member 14A has three or more storage chambers 30, the collection kit 10A will include three or more adapters 60 corresponding to the respective storage chambers 30.
[0061] In the initial state of the collection kit 10A, the first adaptor 60a and the second adaptor 60b may not be provided in the collection kit 10A. For example, similar to the second embodiment (see FIG. 10) and the third embodiment (see FIG. 11) described below, the first adaptor 310a and the second adaptor 310b may be connected to the first outlet pipe portion 34a and the second outlet pipe portion 34b via the first outlet port 300a and the second outlet port 300b. Alternatively, similar to the fourth and fifth embodiments (see FIGS. 12 and 13) described below, the adaptor 310 may be connected to the first outlet pipe portion 34a and the second outlet pipe portion 34b via the branch pipe 17 and the outlet port 300.
[0062] 2, a needle unit 62 is provided inside the first adapter 60a. The needle unit 62 has a needle hub 64 held in the first outlet tube 34a between the first housing 22a and the first adapter 60a, a cap member 66 connected to the needle hub 64, a tubular needle portion 68 held in the cap member 66, and a rubber cover 70 covering the needle portion 68. The lower opening of the first adapter 60a is closed with a release sheet 72.
[0063] The second adapter 60b has the same configuration as the first adapter 60a, and therefore a detailed description of the second adapter 60b will be omitted.
[0064] (2) Configuration of the Collection Kit Jig Next, with reference to FIGS. 4 to 7, a collection kit jig 100 for separating the platelet preparation M from the collection kit 10A into the first sampling container 90a and the second sampling container 90b will be described.
[0065] Hereinafter, the direction along the thickness direction of the collection kit 10A, when the collection kit jig 100 is viewed from the two second support plates 106, will be referred to as the "front." The direction along the thickness direction of the collection kit 10A, when the two first support plates 104 are viewed from the collection kit jig 100, will be referred to as the "rear." In other words, the two first support plates 104 are located forward of the two second support plates 106. Conversely, the two second support plates 106 are located rearward of the two first support plates 104. In addition, the surface of each component facing rearward will be referred to as the "back."
[0066] The collection kit jig 100 has a plate-shaped base 102. Two first support plates 104 are erected on the upper surface of the base 102. The two first support plates 104 are arranged at the left and right ends of the base 102 so as to be aligned parallel to each other.
[0067] Two second support plates 106 are provided upright on the upper surface of the base 102. The two second support plates 106 are arranged parallel to each other. The distance between the two second support plates 106 is smaller than the distance between the two first support plates 104.
[0068] The collection kit jig 100 includes a container holding part 220, a kit holding part 110, and an elevating mechanism 150. The container holding part 220 will be described later.
[0069] The kit holding portion 110 has a base portion 112, a first retainer 114a, a second retainer 114b, and a bracket 116. The base portion 112 is positioned and fixed to the front surfaces of the upper portions of the two first support plates 104. The first retainer 114a is positioned and fixed to the left portion of the front surface of the base portion 112, and the second retainer 114b is positioned and fixed to the right portion of the front surface of the base portion 112. The bracket 116 is positioned and fixed between the first retainer 114a and the second retainer 114b on the front surface of the base portion 112.
[0070] As shown in detail in Fig. 5, a cover 120 is provided on the front surface of the first retainer 114a and the second retainer 114b. A fastener 122 is attached to the front surface of the cover 120. A hook 124 for fastening the fastener 122 is provided on the left portion of the front surface of the first retainer 114a. The right portion of the front surface of the second retainer 114b is connected to the cover 120 via a hinge 126. Fig. 4 shows the cover 120 in a closed state with the fastener 122 fastened to the hook 124. The cover 120 is preferably transparent or translucent.
[0071] As shown in Figure 6, the cover 120 has a clamp portion 130 on its back surface. The clamp portion 130 has a flat plate portion 132 and a first protrusion portion 134a and a second protrusion portion 134b. The first protrusion portion 134a and the second protrusion portion 134b protrude rearward from the back surface of the flat plate portion 132. The first protrusion portion 134a and the second protrusion portion 134b are inclined so as to approach each other from the bottom to the top.
[0072] 5, the front end of bracket 116 has an opening 119. Collection kit 10A is inserted through opening 119 into storage space 118, which is the interior chamber of bracket 116. An operator can visually check collection kit 10A stored in storage space 118 through opening 119.
[0073] The lower part of the bracket 116 has an adapter support portion 136. Because the collection kit 10A includes two adapters 60, the bracket 116 has a first adapter support portion 136a and a second adapter support portion 136b as the adapter support portion 136. The first adapter support portion 136a and the second adapter support portion 136b are generally cylindrical. The first adapter 60a is inserted entirely into the first adapter support portion 136a. The second adapter 60b is inserted entirely into the second adapter support portion 136b.
[0074] The upper part of the bracket 116 has a first slit 140, a second slit 142, and a third slit 144. The first exhaust pipe section 36a is inserted into the first slit 140. The upper part of the first exhaust pipe section 36a is exposed above the bracket 116 through the first slit 140. The first exhaust tube 42a is attached to this upper part. The second exhaust pipe section 36b is inserted into the second slit 142. The upper part of the second exhaust pipe section 36b is exposed above the bracket 116 through the second slit 142. The second exhaust tube 42b is attached to this upper part. The third slit 144 is located between the first slit 140 and the second slit 142. The midstream section 12m of the inflow tube 12 is inserted into the third slit 144. When the collection kit 10A is stored in the storage space 118, the upstream end 12u of the inflow tube 12 is located above the third slit 144. In this manner, interference between the first exhaust pipe section 36 a, the second exhaust pipe section 36 b, and the inlet tube 12 and the bracket 116 is avoided.
[0075] The lifting mechanism 150 has a lifting operation unit 152, a first displacement unit 170, a first guide unit 200, a second displacement unit 210, a second guide unit 230, and a gear mechanism 250. When the lifting operation unit 152 is operated by an operator, the second displacement unit 210 including the container holding unit 220 moves up and down. The container holding unit 220 is disposed below the kit holding unit 110.
[0076] The lifting operation unit 152 has an operation lever 154 arranged on the front surface of the upper part of the two second support plates 106. A support shaft 158 that rotatably supports the operation lever 154 is supported by a guide bracket 160. The operation lever 154 is connected to a first movable platen 172 via two V-shaped arms 162, a connecting rod 164, and a plate nut 166.
[0077] The first displacement unit 170 has the above-described first movable platen 172 and first drive plate 174. The first movable platen 172 and the first drive plate 174 move up and down integrally while being guided by a first guide unit 200. The first movable platen 172, the first drive plate 174, and the first guide unit 200 will be described below.
[0078] The first guide unit 200 has two first guide rods 202 erected on the base 102. Each of the two first guide rods 202 is passed through an insertion hole formed at the left end and right end of the first movable platen 172. The upper portion of each of the two first guide rods 202 is exposed upward from a cylindrical portion 204b of a first flanged collar 204 provided on the upper surface of the first movable platen 172. A first stopper 206 is provided at the upper end of each of the two first guide rods 202. The upper surface of the large-diameter flange portion 204a of the first flanged collar 204 abuts against the lower surface of the first movable platen 172.
[0079] The first guide rod 202 is passed through the inside of a first return spring 208. The lower end of the first return spring 208 abuts against the upper surface of the cylindrical portion 204b of the first flanged collar 204. The upper end of the first return spring 208 abuts against the lower surface of the first stopper 206. The first return spring 208 urges the first movable platen 172 downward via the first flanged collar 204.
[0080] The first driving plate 174 has a first vertical portion 175a extending in the up-down direction and a first horizontal portion 175b extending in the front-rear direction. The first horizontal portion 175b is connected to the underside of the first moving platen 172. The first vertical portion 175a is connected to the front end of the first horizontal portion 175b so as to hang down.
[0081] The second displacement section 210 will now be described. The second displacement section 210 has a second moving platen 212. As shown in Figures 4 and 7, the second moving platen 212 has a base portion 213a extending along the width direction, and a tab portion 213b protruding rearward from approximately the center of the base portion 213a in the width direction.
[0082] 4, the container holding unit 220 has a first container holder 220a and a second container holder 220b provided on the upper surface of the base 213a. The first container holder 220a and the second container holder 220b move up and down integrally with the second movable platen 212.
[0083] As shown in Figure 7, a second driving plate 214 is provided on the upper surface of the tab portion 213b of the second moving platen 212. The second driving plate 214 has a second horizontal portion 215a extending in the front-rear direction and a second vertical portion 215b extending in the up-down direction. The second horizontal portion 215a is connected to the tab portion 213b with the lower surface of the second horizontal portion 215a abutting against the upper surface of the tab portion 213b. Therefore, the second moving platen 212 moves up and down integrally with the second driving plate 214.
[0084] The second guide portion 230 has two second guide rods 232 standing on the base 102. Each of the two second guide rods 232 is passed through an insertion hole (not shown) formed at the left end and right end of the pedestal portion 213a. The upper portion of each of the two second guide rods 232 is exposed upward from a second flanged collar 234. A second stopper 236 is provided at the upper end of each of the two second guide rods 232.
[0085] The second guide rod 232 is passed through the inside of a second return spring 238. The lower end of the second return spring 238 abuts against the upper surface of the second flanged collar 234. The upper end of the second return spring 238 abuts against the lower surface of the second stopper 236. The second return spring 238 urges the second movable platen 212 downward via the second flanged collar 234.
[0086] 7, the gear mechanism 250 has a first rack 252, a second rack 254, and a pinion 256 that meshes with the first rack 252 and the second rack 254. The first rack 252 is disposed on the front surface of the lower part of the first vertical portion 175a of the first drive plate 174. The second rack 254 is disposed on the back surface of the second vertical portion 215b of the second drive plate 214. The pinion 256 is interposed between the first rack 252 and the second rack 254. The pinion 256 is supported via a bearing 260 on an L-shaped stay 258 that is provided on the upper surface of the base 102.
[0087] (3) Collection Method Next, a collection method for separating the platelet preparation M into the first sampling container 90a and the second sampling container 90b using the collection kit jig 100 will be described.
[0088] 3, the operator first connects a medical bag 80 containing a platelet preparation M to the inflow tube 12. Specifically, the medical bag 80 has a supply tube 82. The operator joins this supply tube 82 to the upstream end 12u of the inflow tube 12. At this time, the supply tube 82 is joined to the inflow tube 12 using a sterile joining device without coming into contact with the outside air.
[0089] Next, the operator moves the platelet preparation M to the first storage chamber 30a and the second storage chamber 30b. To do this, the operator opens the lids 46 of the first exhaust tube 42a and the second exhaust tube 42b. To open the lids 46, for example, the lids 46 are loosened from the tube body 44. The lids 46 may also be removed from the tube body 44. The lids 46 may also be opened before the medical bag 80 is connected to the inflow tube 12.
[0090] The operator positions the medical bag 80 above the collection member 14A. The platelet product M flows out of the medical bag 80 by gravity and flows into the main connector 18a of the branch tube 16 via the supply tube 82 and the inflow tube 12. A first sub-connection 18b and a second sub-connection 18c branch off from the main connector 18a. Therefore, the platelet product M is divided into a first branch flow that travels from the main connector 18a through the first sub-connection 18b to the first inflow tube 32a, and a second branch flow that travels from the main connector 18a through the second sub-connection 18c to the second inflow tube 32b.
[0091] The first branch stream passes through the first inlet pipe section 32a and flows into the first storage chamber 30a. As a result, the air stored in the first storage chamber 30a is pushed out by the first branch stream, passes through the first exhaust pipe section 36a, and is exhausted to the atmosphere from the first exhaust stack 42a. Similarly, when the second branch stream passes through the second inlet pipe section 32b and flows into the second storage chamber 30b, the air stored in the second storage chamber 30b is exhausted to the atmosphere from the second exhaust stack 42b through the second exhaust pipe section 36b.
[0092] As the platelet preparation M further flows into the first storage chamber 30a and the second storage chamber 30b, the excess platelet preparation M comes into contact with the hydrophilic filters 48 of the first exhaust stack 42a and the second exhaust stack 42b. This causes the excess platelet preparation M to be trapped in the pores of the hydrophilic filters 48. As a result, the platelet preparation M is retained in the hydrophilic filters 48, which are then blocked. This prevents the platelet preparation M from passing through the hydrophilic filters 48 and flowing out of the first exhaust stack 42a and the second exhaust stack 42b. As a result, the required amount of platelet preparation M is stored in the first storage chamber 30a and the second storage chamber 30b. The required amount is, for example, approximately 8 mL to 10 mL.
[0093] The worker then rotates the lids 46 of the first exhaust stack 42a and the second exhaust stack 42b to close the lids 46. The worker then separates the medical bag 80 from the inflow tube 12 using a tube sealer (high-frequency sealer or ultrasonic sealer) or the like. The tube sealer separates the inflow tube 12 from the supply tube 82 of the medical bag 80 and simultaneously seals the upstream end 12u of the inflow tube 12 by welding. The separation of the inflow tube 12 and the supply tube 82 is performed without exposing the internal flow path to the outside air.
[0094] The medical bag 80 separated from the inlet tube 12 is stored until the culture test is completed, and then is put to use. Meanwhile, the collection kit 10A, which contains the platelet preparation M in the first storage chamber 30a and the second storage chamber 30b, is carried into a clean bench. A collection kit jig 100 shown in Figure 4 is installed on the clean bench.
[0095] The operator inserts the collection kit 10A into the storage space 118 through the opening 119 at the front end of the bracket 116. During this insertion, the operator inserts the first exhaust pipe portion 36a, the second exhaust pipe portion 36b, and the midstream portion 12m of the inlet tube 12 into the first slit 140, the second slit 142, and the third slit 144, respectively. The first exhaust stack 42a and the second exhaust stack 42b may be pre-attached to the first exhaust pipe portion 36a and the second exhaust pipe portion 36b before the collection kit 10A is inserted into the storage space 118. Alternatively, the first exhaust stack 42a and the second exhaust stack 42b may be attached to the first exhaust pipe portion 36a and the second exhaust pipe portion 36b after the collection kit 10A is inserted into the storage space 118.
[0096] The operator closes the cover 120 and engages the fastener 122 with the hook 124. When the cover 120 is closed, the first protrusion 134a crushes the relay tube 302 or the first sub-connection 18b of the branch pipe 16, blocking communication between the inlet tube 12 and the first inlet pipe section 32a. At the same time, the second protrusion 134b crushes the relay tube 302 or the second sub-connection 18c of the branch pipe 16, blocking communication between the inlet tube 12 and the second inlet pipe section 32b.
[0097] Alternatively, a welded seal may be formed on each of the first and second sub-connections 18b, 18c to block communication between the inlet tube 12 and the first and second inlet pipe sections 32a, 32b. The welded seal may be formed by welding the inner circumferential surfaces of the first and second sub-connections 18b, 18c using, for example, an ultrasonic sealer or a high-frequency sealer. Alternatively, the first and second sub-connections 18b, 18c may be crushed using a clamp 86 or the like shown in FIG. 10. When this configuration is employed, the cover 120 does not need to have the clamp 130 (see FIG. 6).
[0098] In either case, the first storage chamber 30a and the second storage chamber 30b are mutually independent internal chambers. Therefore, the platelet preparation M stored in the first storage chamber 30a based on the above-mentioned first branch stream does not flow into the second inlet pipe portion 32b or the second storage chamber 30b. Similarly, the platelet preparation M stored in the second storage chamber 30b based on the second branch stream does not flow into the first inlet pipe portion 32a or the first storage chamber 30a. In other words, movement of the platelet preparation M between the first storage chamber 30a and the second storage chamber 30b is prevented.
[0099] To transfer the platelet product M from the collection kit 10A to the first sampling container 90a and the second sampling container 90b, the operator peels off the release sheets 72 from the first adapter 60a and the second adapter 60b, and then grasps one end of the operating lever 154 shown in Fig. 4 and rotates the operating lever 154 so that the end moves downward in the direction of arrow A in Fig. 4. This causes the connecting rod 164 to move downward, as shown in Fig. 8.
[0100] As described above, the connecting rod 164 is connected to the first moving platen 172 via the plate nut 166, and the first driving plate 174 is connected to the first moving platen 172. Therefore, as shown in Fig. 8 , as the connecting rod 164 moves down, the first moving platen 172 and the first driving plate 174 move down together.
[0101] 7, the first rack 252 provided on the first vertical portion 175a of the first drive plate 174 meshes with the pinion 256, and the pinion 256 meshes with the second rack 254 provided on the second vertical portion 215b of the second drive plate 214. Therefore, when the first movable platen 172 and the first drive plate 174 descend, the pinion 256 is pushed downward by the first rack 252 and rotates. As a result, the second rack 254 is pushed upward by the pinion 256. As a result, the second drive plate 214 and the second movable platen 212 to which the second drive plate 214 is connected rise together.
[0102] When the second moving platen 212 moves up, the second return spring 238 disposed between the second flanged collar 234 and the second stopper 236 is compressed in the axial direction. That is, the second moving platen 212 moves up against the elastic force of the second return spring 238.
[0103] The container holder 220 rises integrally with the second movable platen 212. As a result, the first sampling container 90a is connected to the first adapter 60a, and the second sampling container 90b is connected to the second adapter 60b. The needle 68 of the first adapter 60a penetrates the stopper 93 (see FIGS. 4 and 9) of the first sampling container 90a, and the needle 68 of the second adapter 60b penetrates the stopper 93 of the second sampling container 90b. The rubber cover 70 is pressed by the stopper 93 and contracts, moving toward the cap member 66.
[0104] In this state, the worker rotates the lid portions 46 of the first exhaust cylinder 42 a and the second exhaust cylinder 42 b to open the lid portions 46. To open the lid portions 46, the worker may loosen the screws connecting the lid portions 46 to the cylinder body 44, or remove the lid portions 46 from the cylinder body 44.
[0105] When the lid 46 is in the open state, atmospheric air (air) flows into the tube body 44. Some of the atmospheric air flows into the first storage chamber 30a and the second storage chamber 30b via the first exhaust pipe 36a and the second exhaust pipe 36b, respectively, while encountering resistance from the hydrophilic filter 48. However, the resistance of the hydrophilic filter 48 limits the amount of atmospheric air that flows into the first storage chamber 30a and the second storage chamber 30b.
[0106] The atmosphere applies pressure to the platelet preparation M contained in each of the first storage chamber 30a and the second storage chamber 30b. In the first storage chamber 30a, the pressure acts from the upper first exhaust pipe section 36a toward the lower first outflow pipe section 34a. Furthermore, a negative pressure exists within the first sampling container 90a. Therefore, the platelet preparation M in the first storage chamber 30a moves toward the first sampling container 90a via the first outflow pipe section 34a. As a result, a first sample MS1 is collected in the first sampling container 90a, as shown in FIG. 9 .
[0107] The operator can check the inflow amount of the first sample MS1 by visually checking the scale 91 provided on the first sampling container 90a. When the inflow amount of the first sample MS1 reaches a predetermined amount, the operator closes the lid 46 of the first exhaust tube 42a. This completes the transfer of the platelet preparation M from the first storage chamber 30a to the first sampling container 90a.
[0108] The platelet preparation M in the second storage chamber 30b is similarly transferred to the second sampling container 90b. As a result, a second sample MS2 is collected in the second sampling container 90b. The second sample MS2 may be collected before or after the first sample MS1, or may be collected simultaneously with the first sample MS1.
[0109] Next, the operator rotates the operating lever 154 so as to return it to the position shown in FIG. 4 . This elastically expands the second return spring 238. Accordingly, the second movable platen 212 is urged downward by the second return spring 238 via the second flanged collar 234. As a result, the second movable platen 212 and the container holder 220 descend together. As the container holder 220 descends, the first sampling container 90a is removed from the first adaptor 60a, and the second sampling container 90b is removed from the second adaptor 60b. The above steps complete the collection (sampling) of the platelet product M using the collection kit 10A.
[0110] Following the descent of the second moving platen 212, in the opposite manner to the above, the second rack 254 pushes the pinion 256 upward, and the pinion 256 pushes the first rack 252 upward. As a result, the first driving plate 174 and the first moving platen 172 rise and return to the positions shown in FIG.
[0111] Next, 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 90a is used, for example, for anaerobic culture to observe whether anaerobic bacteria grow. The second sample MS2 in the second sampling container 90b is used, for example, for aerobic culture to observe whether aerobic bacteria grow. In both tests, the first sampling container 90a and the second sampling container 90b are used as culture bottles. If the first sample MS1 and the second sample MS2 pass the culture test, the platelet preparation M in the medical bag 80 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).
[0112] The illustrated collection kit jig 100 includes an elevating mechanism 150 that raises and lowers the container holding portion 220. Alternatively, the collection kit jig 100 may include an elevating mechanism that raises and lowers the kit holding portion 110. In this configuration, the container holding portion 220 may be positioned and fixed to the base 102.
[0113] The collection kit 10A according to the first embodiment has the following advantages.
[0114] A collection kit 10A for collecting a collection target (platelet preparation M) contained in a medical bag 80 shown in Figure 3 into multiple sampling containers 90 (first sampling container 90a and second sampling container 90b) includes an inflow tube 12 and a collection member 14A. The medical bag 80 is connected to the inflow tube 12. The collection member 14A is connected downstream of the inflow tube 12.
[0115] The collection member 14A has a plurality of storage sections 22 and a plurality of storage chambers 30 formed inside the plurality of storage sections 22, each of which stores a platelet preparation M. The collection kit 10A includes a plurality of outflow pipe sections 34 and at least one exhaust section 40.
[0116] The plurality of outflow pipe sections 34 are connected to the plurality of storage chambers 30 and transfer the platelet preparation M from the plurality of storage sections 22 to the plurality of sampling containers 90, respectively. At least one exhaust section 40 exhausts the air inside the plurality of storage chambers 30 to the outside of the collection member 14A.
[0117] In the above configuration, the collection member 14A is made of an inflexible material. Therefore, when the platelet preparation M flows into each storage chamber 30, and when the platelet preparation M flows out from each storage chamber 30 into the sampling container 90, the collection member 14A does not substantially deform. In other words, the collection member 14A has the property of maintaining its initial shape (shape retention). Therefore, each storage section 22 also has shape retention.
[0118] Therefore, deformation of each storage section 22 is suppressed when the platelet preparation M flows into each storage chamber 30. As a result, the amount of platelet preparation M transferred from the medical bag 80 to each storage chamber 30 is approximately the same. That is, the amount of platelet preparation M stored in each storage chamber 30 is constant. Therefore, the sample amount of platelet preparation M collected in each sampling container 90 is stable.
[0119] The sampling member 14A has a plurality of inlet pipe sections 32 provided in each of the plurality of storage sections 22 and connected to each of the plurality of storage chambers 30. The inlet tube 12 is connected to the inlet pipe sections 32 via a branch pipe 16 (or branch pipe 17) connected to the downstream end 12d of the inlet tube 12.
[0120] According to this configuration, the platelet preparation M can be simultaneously dispensed into a plurality of storage chambers 30. Therefore, the sampled amount of the platelet preparation M collected in the sampling container 90 becomes more stable.
[0121] The inflow pipe portion 32 is a part of the collection member 14A and is therefore rigid, so that the branch pipe 16 (or branch pipe 17) can be easily connected to the inflow pipe portion 32.
[0122] The collection member 14A has a tube protection portion 20 that covers the inflow tube 12.
[0123] Because the inflow tube 12 is surrounded by the tube protection part 20, the inflow tube 12 is prevented from being accidentally crushed. As a result, the inflow tube 12 is prevented from being blocked due to being crushed. This makes it easy to transfer the platelet preparation M from the medical bag 80 to each storage chamber.
[0124] The tube protection portion 20 is integrally connected to a plurality of housing portions 22 .
[0125] In this case, it is possible to fabricate the collection member 14A in which the tube protection part 20 and the plurality of storage parts 22 are integrally constructed. Therefore, the collection member 14A can be constructed more efficiently than when the tube protection part 20 and the plurality of storage parts 22 are fabricated separately and then the plurality of storage parts 22 are connected to the tube protection part 20.
[0126] The material of the collection member 14A is resin, typical examples of which include polycarbonate (PC), polypropylene (PP), polystyrene (PS), polyethylene terephthalate (PET), glycol-modified polyethylene terephthalate (PETG), and polyvinyl chloride (PVC).
[0127] Resin is lightweight, which allows for a reduction in the weight of collection kit 10A. Furthermore, resin is hard, which makes it easy to form collection member 14A that is inflexible.
[0128] The resin is transparent or translucent.
[0129] According to this configuration, the amount of platelet preparation M contained inside the multiple storage sections 22 (storage chambers 30) can be easily confirmed.
[0130] The exhaust unit 40 has an exhaust tube 42. The exhaust tube 42 has a tube body 44 having an opening 50, and a lid 46 that can open and close the opening 50 of the tube body 44.
[0131] When the platelet preparation M is transferred from the medical bag 80 to each storage chamber 30, the lid portion 46 is opened, allowing the air inside each storage chamber 30 to be exhausted to the outside of the collection member 14A through the opening 50. After the platelet preparation M has been transferred from the medical bag 80 to each storage chamber 30, the lid portion 46 is closed, allowing the platelet preparation M to remain contained in each storage chamber 30.
[0132] The exhaust stack 42 includes a hydrophilic filter 48 .
[0133] The hydrophilic filter 48 allows air to pass through before it is wet with the liquid platelet preparation M, but prevents air from passing through after it is wet with the platelet preparation M. Therefore, even if the lid 46 is opened and atmospheric air (air) is taken in through the opening 50 after the platelet preparation M has overflowed from each storage chamber 30 and wetted the hydrophilic filter 48, the inflow of air into each storage chamber 30 is prevented. Therefore, the platelet preparation M transferred to the sampling container 90 can be used as a sample for an anaerobic culture test.
[0134] The collection kit 10A includes an adapter 60 that is connected downstream of the outflow pipe section 34 and can be connected to multiple sampling containers 90. In the illustrated example, there are two (multiple) adapters 60, but the number of adapters 60 may be one. In other words, the collection kit 10A includes at least one adapter 60.
[0135] The adapter 60 allows the storage unit 22 and the sampling container 90 to be easily connected via the outflow pipe 34. Furthermore, because the sampling kit 10A is equipped with the adapter 60 before use, the operator does not have to go through the trouble of connecting the adapter 60 to the outflow pipe 34 each time the sampling kit 10A is used. As a result, the sampling operation can be performed efficiently.
[0136] (4) Other Embodiments Next, a collection kit 10B according to a second embodiment to a collection kit 10G according to a seventh embodiment will be described with reference to Figures 10 to 15. Components identical to those shown in Figures 1 to 9 are designated by the same reference numerals, and detailed descriptions thereof will be omitted. Although the reference numerals for the collection members in the second to seventh embodiments are different from each other, the material of all the collection members is inflexible, as in the first embodiment.
[0137] 10 is a schematic front view of a sampling kit 10B according to a second embodiment. The sampling kit 10B includes a sampling member 14B. The sampling member 14B has a first storage section 22a and a second storage section 22b. The inner chamber of the first storage section 22a is a first storage chamber 30a, and the inner chamber of the second storage section 22b is a second storage chamber 30b. The sampling member 14B further includes a first inlet pipe section 32a and a second inlet pipe section 32b, a first outlet pipe section 34a and a second outlet pipe section 34b, and a first exhaust pipe section 36a and a second exhaust pipe section 36b.
[0138] The first inlet pipe 32a is located on the right side of the upper part of the first housing portion 22a, closer to the second housing portion 22b. The first exhaust pipe 36a is located on the left side of the upper part of the first housing portion 22a, away from the second housing portion 22b. The first exhaust pipe 36a and the first exhaust tube 42a form the first exhaust portion 40a. The first outlet pipe 34a is provided at the lower part of the first housing portion 22a.
[0139] The second inlet pipe 32b is located on the left side of the upper part of the second housing portion 22b, closer to the first housing portion 22a. The second exhaust pipe 36b is located on the right side of the upper part of the second housing portion 22b, away from the first housing portion 22a. The second exhaust pipe 36b and the second exhaust tube 42b form the second exhaust portion 40b. The second outlet pipe 34b is provided at the lower part of the second housing portion 22b.
[0140] The downstream end 12d of the inflow tube 12 is connected to the main connection portion 18a of the branch pipe 16. The first inflow pipe portion 32a and the second inflow pipe portion 32b are connected to the first sub-connection portion 18b and the second sub-connection portion 18c of the branch pipe 16, respectively, via the relay tube 302. In this way, the inflow tube 12 is connected to the first inflow pipe portion 32a and the second inflow pipe portion 32b via the branch pipe 16 above the first storage portion 22a and the second storage portion 22b.
[0141] A first outlet port 300a is connected to the first outlet pipe section 34a, and a second outlet port 300b is connected to the second outlet pipe section 34b. The first outlet port 300a has a breakable plug (not shown) inside. In the initial state, the plug seals the first outlet port 300a. When the platelet preparation M is transferred from the first storage chamber 30a to the first sampling container 90a, the plug is broken by being bent. This opens the first outlet port 300a. Similarly, the second outlet port 300b opens when the internal plug (not shown) breaks.
[0142] A first adaptor 310a is connected to the first outlet pipe 34a via a first outlet port 300a. The first adaptor 310a has a housing tube 312 capable of housing the neck of the first sampling container 90a, a communication tube 314 provided at the upper end of the housing tube 312, a tubular needle 316 disposed inside the housing tube 312, and a rubber cover 318 covering the needle 316. The housing tube 312 has an openable lid 320. A release sheet 72 (see FIGS. 1 and 2) may be used instead of the lid 320.
[0143] A needle 316 in the housing cylinder 312 is connected to the communication tube 314. When the neck of the first sampling container 90a (see FIG. 9) is inserted into the housing cylinder 312, the needle 316 pierces the plug 93 of the first sampling container 90a. Therefore, when the plug is broken and the first outlet port 300a is opened, the first sampling container 90a and the first storage chamber 30a are connected via the communication tube 314 and the needle 316.
[0144] When the needle 316 punctures the stopper 93 of the first sampling container 90a, the rubber cover 318 is pressed toward the collection member 14A and compressed. The needle 316 penetrates the compressed rubber cover 318. When the needle 316 is removed from the stopper 93 of the first sampling container 90a, the rubber cover 318 stretches due to its elastic restoring force and covers the needle 316 again.
[0145] The second adapter 310b has a configuration similar to that of the first adapter 310a. When the needle 316 of the second adapter 310b penetrates the plug 93 of the second sampling container 90b and the plug is broken to open the second outlet port 300b, the second sampling container 90b and the second storage chamber 30b communicate with each other.
[0146] In the initial state of the collection kit 10B, the first adapter 310a and the second adapter 310b may not be provided in the collection kit 10B. In this case, when the collection kit 10B is used, the first adapter 310a and the second adapter 310b are connected to the collection kit 10B.
[0147] In this configuration, the first protrusion 134a and the second protrusion 134b (see FIG. 6) abut against the first sub-connection portion 18b and the second sub-connection portion 18c, respectively. Alternatively, as shown in FIG. 10, clamps 86 may be attached to the first sub-connection portion 18b and the second sub-connection portion 18c. In this state, the platelet preparation M is transferred from the first storage chamber 30a and the second storage chamber 30b to the first sampling container 90a and the second sampling container 90b, respectively, in the same manner as in the first embodiment.
[0148] FIG. 11 is a schematic front view of a collection kit 10C according to a third embodiment. The collection kit 10C includes a collection member 14C. The collection member 14C has a first storage section 22a and a second storage section 22b. The collection member 14C further includes a first inlet pipe section 32a and a second inlet pipe section 32b, a first outlet pipe section 34a and a second outlet pipe section 34b, and a collecting exhaust pipe section 38. That is, the collection kit 10C includes one exhaust section 40. Furthermore, the collection kit 10C can be connected to two adapters 310 (a first adapter 310a and a second adapter 310b) that are separate from the collection kit 10C.
[0149] The first inlet pipe 32a is located on the left side of the upper portion of the first storage section 22a, spaced apart from the second storage section 22b. The second inlet pipe 32b is located on the right side of the upper portion of the second storage section 22b, spaced apart from the first storage section 22a. The downstream end 12d of the inlet tube 12 is connected to the first storage chamber 30a and the second storage chamber 30b via the branch pipe 16, as in the second embodiment.
[0150] The collecting exhaust pipe section 38 has a first branch section 39a provided in the first housing section 22a, a second branch section 39b provided in the second housing section 22b, and a junction section 39c where the first branch section 39a and the second branch section 39b join. The first branch section 39a is located on the right side of the upper part of the first housing section 22a, closer to the second housing section 22b. The second branch section 39b is located on the left side of the upper part of the second housing section 22b, closer to the first housing section 22a. An exhaust tube 42 is provided at the junction section 39c. The first outflow pipe section 34a is provided in the lower part of the first housing section 22a.
[0151] The first outlet pipe 34a is provided at the bottom of the first housing 22a. A first adaptor 310a is connected to the first outlet pipe 34a via a first outlet port 300a. The second outlet pipe 34b is provided at the bottom of the second housing 22b. A second adaptor 310b is connected to the second outlet pipe 34b via a second outlet port 300b.
[0152] In this configuration, when the platelet preparation M flows into the first storage chamber 30a and the second storage chamber 30b, the air in the first storage chamber 30a flows through the first branch portion 39a and the junction portion 39c, and is then exhausted to the atmosphere via the exhaust tube 42. The air in the second storage chamber 30b flows through the second branch portion 39b and the junction portion 39c, and is then exhausted to the atmosphere via the exhaust tube 42.
[0153] Thereafter, in the same manner as in the second embodiment, the platelet preparation M is transferred to the first sampling container 90a attached to the first adapter 310a, and the platelet preparation M is transferred to the second sampling container 90b attached to the second adapter 310b.
[0154] 12 is a schematic front view of a sampling kit 10D according to a fourth embodiment. The sampling kit 10D includes a sampling member 14D. The sampling member 14D has a first storage section 22a, a second storage section 22b, and a tube protection section 20. The inner chamber of the first storage section 22a is the first storage chamber 30a, and the inner chamber of the second storage section 22b is the second storage chamber 30b. The sampling member 14D includes a first inlet / outlet pipe section 35a that also serves as the first inlet pipe section 32a and the first outlet pipe section 34a, and a second inlet / outlet pipe section 35b that also serves as the second inlet pipe section 32b and the second outlet pipe section 34b. The sampling member 14D further includes a first exhaust pipe section 36a and a second exhaust pipe section 36b.
[0155] The midstream section 12m of the inflow tube 12 is inserted into the tube protector 20. A branch pipe 17 is provided at the downstream end 12d of the inflow tube 12. The branch pipe 17 has a main connection section 18a, a first sub-connection section 18b, a second sub-connection section 18c, and an adapter connection section 18d. The downstream end 12d is connected to the main connection section 18a. A first inlet / outlet pipe section 35a and a second inlet / outlet pipe section 35b are connected to the first sub-connection section 18b and the second sub-connection section 18c, respectively. An adapter 310 is connected to the adapter connection section 18d via the outlet port 300. In other words, the sampling kit 10D can be connected to a single adapter 310 that is separate from the sampling member 14D.
[0156] In this configuration, the platelet preparation M flows into the first storage chamber 30a and the second storage chamber 30b via the first inlet / outlet tube 35a and the second inlet / outlet tube 35b. Thereafter, when transferring the platelet preparation M from the first storage chamber 30a to a sampling container (not shown) attached to the adapter 310, the operator squeezes the upstream end 12u of the inlet tube 12 and the second sub-connector 18c with a clamp 86, for example. Therefore, only the platelet preparation M in the first storage chamber 30a flows into the sampling container via the first inlet / outlet tube 35a, the first sub-connector 18b, and the outlet port 300.
[0157] After a predetermined amount of platelet product M has been transferred to the sampling container, the operator removes the sampling container from the adapter 310. Next, the operator attaches another sampling container (not shown) to the adapter 310. Meanwhile, the operator, for example, squeezes the first sub-connector 18b with a clamp 86. The clamp 86 attached to the second sub-connector 18c may be removed or left attached. In either case, only the platelet product M in the second storage chamber 30b flows into the sampling container via the second inlet / outlet tube 35b, the second sub-connector 18c, and the outlet port 300. If the collection kit 10D has another storage chamber 30 in addition to the first storage chamber 30a and the second storage chamber 30b, the above process is repeated. In this manner, the platelet product M can be divided into multiple sampling containers.
[0158] 13 is a schematic front view of a sampling kit 10E according to a fifth embodiment. The sampling kit 10E includes a sampling member 14E. The sampling member 14E has a first storage section 22a, a second storage section 22b, and a tube protection section 20. The sampling member 14E further includes a first inlet / outlet pipe section 35a, a second inlet / outlet pipe section 35b, and a collective exhaust pipe section 38. A branch pipe 17 is provided at the downstream end 12d of the inlet tube 12. That is, the sampling kit 10E includes one exhaust section 40. Furthermore, the sampling kit 10E can be connected to one adapter 310 that is separate from the sampling member 14E.
[0159] As in the fourth embodiment, in this configuration, the platelet preparation M flows into the first storage chamber 30a and the second storage chamber 30b via the first inlet / outlet pipe 35a and the second inlet / outlet pipe 35b. During this flow, the air in the first storage chamber 30a flows through the first branch portion 39a and the junction portion 39c, and is then exhausted to the atmosphere via the exhaust tube 42. The air in the second storage chamber 30b flows through the second branch portion 39b and the junction portion 39c, and is then exhausted to the atmosphere via the exhaust tube 42.
[0160] Thereafter, in the same manner as in the fourth embodiment, the platelet preparation M contained in each of the first and second storage chambers 30a and 30b is transferred to a sampling container (not shown).
[0161] In the sampling kit 10D (see FIG. 12) and the sampling kit 10E (see FIG. 13), the first inlet / outlet pipe 35a also serves as the first inlet / outlet pipe 32a and the first outlet pipe 34a, and the second inlet / outlet pipe 35b also serves as the second inlet / outlet pipe 32b and the second outlet pipe 34b. This simplifies the configuration of the sampling members 14D, 14E and the sampling kits 10D, 10E.
[0162] 14 is a schematic front view of a sampling kit 10F according to a sixth embodiment. The sampling kit 10F includes a sampling member 14F. The sampling member 14F has a first storage section 22a and a second storage section 22b. The sampling member 14F further includes a first inlet pipe section 32a and a second inlet pipe section 32b, a first outlet pipe section 34a and a second outlet pipe section 34b, and a first exhaust pipe section 36a and a second exhaust pipe section 36b. That is, the sampling kit 10F includes two exhaust sections 40 (a first exhaust section 40a and a second exhaust section 40b).
[0163] The collection kit 10F includes a junction pipe 304. The junction pipe 304 has a first branch portion 305b, a second branch portion 305c, and a junction portion 305a. The first outlet pipe portion 34a is connected to the first branch portion 305b via a relay tube 302. The second outlet pipe portion 34b is connected to the second branch portion 305c via another relay tube 302. An adapter 310 is connected to the junction portion 305a via the outlet port 300. In this manner, a single adapter 310 that is separate from the collection member 14F can be connected to the collection member 14F.
[0164] In the collection kit 10F, similar to the collection kit 10B according to the second embodiment, the platelet preparation M flows into each of the first storage chamber 30a and the second storage chamber 30b from the top. Thereafter, similar to the fourth and fifth embodiments, the platelet preparation M stored in each of the first storage chamber 30a and the second storage chamber 30b is transferred to a sampling container (not shown).
[0165] FIG. 15 is a schematic front view of a sampling kit 10G according to the seventh embodiment. The sampling kit 10G includes a sampling member 14G. The sampling member 14G has a first storage section 22a and a second storage section 22b. The sampling member 14G further includes a first inlet pipe section 32a and a second inlet pipe section 32b, a first outlet pipe section 34a and a second outlet pipe section 34b, and a collecting exhaust pipe section 38. That is, the sampling kit 10G includes one exhaust section 40. Furthermore, as in the sixth embodiment, a single adapter 310 separate from the sampling member 14G can be connected to the sampling member 14G.
[0166] In the collection kit 10G, similar to the collection kit 10C according to the third embodiment, the platelet preparation M flows into each of the first storage chamber 30a and the second storage chamber 30b from above. During this flow, the air in the first storage chamber 30a flows through the first branch portion 39a and the junction portion 39c, and is then exhausted to the atmosphere via the exhaust tube 42. The air in the second storage chamber 30b flows through the second branch portion 39b and the junction portion 39c, and is then exhausted to the atmosphere via the exhaust tube 42.
[0167] Thereafter, in the same manner as in the fourth to sixth embodiments, the platelet preparation M contained in each of the first and second storage chambers 30a and 30b is transferred to a sampling container (not shown).
[0168] In the collection kit 10F (see FIG. 14) and the collection kit 10G (see FIG. 15), a junction pipe 304 is connected downstream of the first outflow pipe section 34a and the second outflow pipe section 34b, and an adapter 310 is further connected to the junction section 305a of the junction pipe 304. This makes it possible to easily connect one adapter 310 to multiple outflow pipe sections 34. Since there is only one adapter 310, the configuration of the collection kits 10F and 10G can be simplified.
[0169] The second to seventh embodiments illustrate examples in which the sampling kits 10B to 10G are connected to adapters 310 that are separate from the sampling members 14B to 14G. However, the sampling kits 10B to 10G may also have the sampling members 14B to 14G and the adapter 310 integrated together, similar to the sampling kit 10A (see FIGS. 1 and 2).
[0170] As can be seen from the above, the collection kit is not limited to the collection kit 10A shown in Figures 1 and 2. When transferring the platelet preparation M from the first storage chamber 30a and the second storage chamber 30b of each of the collection kits 10B to 10G to the first sampling container 90a and the second sampling container 90b, respectively, a collection kit jig configured similarly to the collection kit jig 100 shown in Figures 4 and 8 can be used. However, the kit holder 110 employs a bracket 116 having a shape corresponding to the shape of the collection kits 10B to 10G.
[0171] The collection kit 10B according to the second embodiment to the collection kit 10G according to the seventh embodiment have the same effects as the collection kit 10A according to the first embodiment.
[0172] The present invention is not limited to the above disclosure, and various configurations can be adopted without departing from the gist of the present invention.
Claims
1. A collection kit for collecting samples contained in a medical bag into a plurality of sampling containers, comprising: an inflow tube to which the medical bag is connected; and a collection member connected downstream of the inflow tube, wherein the collection member has a plurality of storage sections and a plurality of storage chambers formed inside the plurality of storage sections, respectively, for storing the samples, wherein the collection kit comprises: a plurality of outflow pipe sections connected to the plurality of storage chambers, respectively, for transporting the samples from the plurality of storage sections to the plurality of sampling containers, and at least one exhaust section for exhausting air inside the plurality of storage chambers to the outside of the collection member, wherein the collection member is made of a non-flexible material.
2. A collection kit as described in claim 1, wherein the collection member has a plurality of inlet pipe sections provided in each of the plurality of storage sections and connected to each of the plurality of storage chambers, and the inlet tube is connected to the plurality of inlet pipe sections via a branch pipe connected to the downstream end of the inlet tube.
3. A collection kit as described in claim 2, wherein each of the multiple inlet pipe sections also serves as a multiple of the outlet pipe sections, and the branch pipe has a connection section to which outlet ports that communicate with each of the multiple outlet pipe sections are connected.
4. A collection kit as described in claim 2, wherein the plurality of inlet pipe sections and the plurality of outlet pipe sections are separate and further comprising a junction pipe connected downstream of the plurality of outlet pipe sections.
5. The collection kit according to claim 1, wherein the collection member has a tube protector that covers the inflow tube.
6. A collection kit according to claim 5, wherein the tube protection section is integrally connected to a plurality of the storage sections.
7. A collection kit according to any one of claims 1 to 6, wherein the material of the collection member is resin.
8. The collection kit of claim 7, wherein the resin is transparent or translucent.
9. A collection kit as described in claim 1, wherein the exhaust section has an exhaust tube, and the exhaust tube has a tube body having an opening, and a lid portion that can freely open and close the opening of the tube body.
10. The collection kit of claim 9, wherein the exhaust stack includes a hydrophilic filter.
11. A collection kit according to claim 1, comprising at least one adapter connected downstream of a plurality of said outlet tubing sections and connectable to a plurality of said sampling containers.
Citation Information
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