Collecting kit, and collecting method
The collection kit addresses inefficiencies in blood product culturing by using a flexible sheet-welded bag with storage chambers and a flow path switching unit for efficient, cost-effective distribution into multiple sampling containers.
Patent Information
- Application Number
- PCT/JP2025/006364
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-02-29
- Filing Date
- 2025-02-25
- Publication Date
- 2025-09-04
AI Technical Summary
Existing methods for culturing blood products in multiple containers are inefficient, complex, and costly, lacking a simple structure for precise sample collection into multiple sampling containers.
A collection kit with an inflow tube, a collection bag formed by welding flexible sheets, multiple storage chambers, a single outflow port, and a flow path switching unit that allows selective connection to multiple sampling containers, enabling efficient and cost-effective sample distribution.
The kit enhances work efficiency by allowing precise collection of predetermined amounts into multiple containers with a simple structure, improving safety and reducing costs.
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Figure JP2025006364_04092025_PF_FP_ABST
Abstract
Description
Collection kit and collection method
[0001] The present invention relates to a collection kit and a collection method for transferring a collection target contained in a medical bag into a plurality of sampling containers.
[0002] Blood products include red blood cell products, plasma products, platelet products, and whole blood products. To ensure safety, small samples of blood products may be collected and cultured. In a culture test, the sample is collected in a culture bottle (sampling container), and the bottle is placed in an environment favorable for bacterial growth to detect the presence or absence of pathogens.
[0003] Below, the procedure for transferring a platelet preparation from a medical bag containing a platelet preparation (hereinafter referred to as a platelet bag) to two culture bottles will be explained using the example of the medical bag.
[0004] A small-capacity collection bag is connected to the platelet bag, and a portion of the platelet product from the platelet bag is transferred to the collection bag. The collection bag is then detached from the platelet bag. Next, in a clean bench, the collection bag is connected to a tube extending from a sample collection tube, and a specified amount of the platelet product is transferred from the collection bag to the sample collection tube using the scale on the sample collection tube as a guide. Two culture bottles are then connected to the sample collection tube in sequence, and the specified amounts of the platelet product are transferred to the two culture bottles. One of the two culture bottles is used for anaerobic culture, and the other is used for aerobic culture.
[0005] For example, US Pat. No. 8,777,921 discloses a collection kit for collecting samples from medical bags.
[0006] U.S. Patent No. 8,777,921
[0007] To further improve the safety of blood products, culture testing of all blood products is being considered. Therefore, there is a need to improve the work efficiency of culture testing of blood products. Furthermore, when performing culture testing of all blood products, it is desirable that the equipment for dividing blood products into culture bottles has a simple structure and is low-cost. It is also desirable that a predetermined amount of the sample can be collected in each of multiple sampling containers.
[0008] The present invention aims to solve the above-mentioned problems.
[0009] (1) A first aspect of the present invention is a collection kit for collecting a sample contained in a medical bag into a plurality of sampling containers, the collection kit comprising: an inflow tube to which the medical bag is connected; and a collection bag connected downstream of the inflow tube and formed by welding two flexible sheets together. The collection bag has a plurality of storage chambers for storing the sample, a single outflow port for transferring the sample from the plurality of storage chambers to the plurality of sampling containers, respectively, at least one exhaust section for exhausting air from the plurality of storage chambers, a single main flow path connecting the inflow tube and the outflow port, and a plurality of connecting flow paths provided between the main flow path and the plurality of storage chambers and connecting each of the storage chambers to the main flow path.
[0010] This collection kit includes an inlet tube to which a medical bag is connected, thereby improving work efficiency when collecting samples into multiple sampling containers. Furthermore, since each of the multiple storage chambers can accommodate a sample, it is possible to collect a predetermined amount of sample. By providing a single outlet port for sequentially collecting samples into multiple sampling containers, a collection kit with multiple storage chambers can be manufactured with a simple structure and at low cost.
[0011] (2) In the collection kit described in (1) above, the collection bag has a connection portion that connects the multiple connection flow paths to the main flow path, and the main flow path has an inlet side flow path that connects the connection portion to the inlet tube and an outlet side flow path that connects the connection portion to the outlet port, and the collection kit may also include a flow path switching portion that selectively connects any one of the multiple connection flow paths to the outlet side flow path.
[0012] With this configuration, the flow path switching unit can easily switch the communication between any one of the plurality of storage chambers and the outlet-side flow path via the connecting flow path.
[0013] (3) In the collection kit described in (2) above, the collection bag may have a cutout portion in which a portion of the flexible sheet is cut out in the thickness direction of the collection bag so as to surround the connection portion, and the flow path switching portion may be provided in the cutout portion.
[0014] With this configuration, by providing the flow path switching section in the cutout section, it is possible to attach the flow path switching section without crushing the multiple storage chambers and main flow path in the flexible sheet in the thickness direction.
[0015] (4) In the collection kit described in (2) or (3) above, the flow path switching unit includes a switching member that can rotate relative to the collection bag, and the switching member has a blocking portion that selectively blocks one of the multiple connection flow paths. By selecting the rotational position of the switching member, one of the multiple connection flow paths can be blocked by the blocking portion.
[0016] With this configuration, by rotating the switching member, it is possible to effectively switch the communication state between one of the plurality of connecting flow paths and the outlet-side flow path.
[0017] (5) In the collection kit described in (4) above, the flow path switching unit has a housing that rotatably holds the switching member, and the switching member is arranged to be movable in the thickness direction of the collection bag relative to the housing, and the switching member may move in the thickness direction toward the connecting flow path, causing the blocking unit to press the connecting flow path toward the housing.
[0018] With this configuration, when the flow path switching section switches between the open and closed states of the connection flow paths, the blocking section can be pressed against the connection flow path to effectively block the connection flow path.
[0019] (6) In the collection kit described in (4) or (5) above, the blocking portion of the switching member is capable of blocking the inlet side flow path, and by selecting the rotational position of the switching member, one of the multiple connecting flow paths and the inlet side flow path may be blocked by the blocking portion.
[0020] With this configuration, when connecting one of the multiple connecting flow paths to the outlet flow path, the connection to the inlet flow path is blocked, thereby effectively preventing the sample from moving toward the inlet tube.
[0021] (7) In the collection kit described in (2) or (3) above, the flow path switching unit may include a plurality of blocking units capable of blocking each of the plurality of connecting flow paths, and the plurality of blocking units may have a plurality of blocking members that can move toward the plurality of connecting flow paths, and the plurality of blocking members may be capable of selectively pressing the plurality of connecting flow paths.
[0022] With this configuration, by moving each of the blocking members in the blocking sections, it is possible to selectively press and block the plurality of connecting flow paths.
[0023] (8) In the collection kit described in (7) above, the flow path switching unit may have a single housing that movably holds the multiple blocking members, and the multiple blocking members may each have multiple operating units that are provided on the housing and exposed from the housing, and may include multiple pressing members that press the blocking members toward each of the multiple connecting flow paths by operating the operating units.
[0024] With this configuration, by operating each of the multiple operating parts, the blocking member can be effectively moved toward each of the multiple connecting flow paths by the pressing member. By providing multiple blocking parts in a single housing, the flow path switching unit can be configured compactly.
[0025] (9) A second aspect of the present invention is a collection method for collecting collection objects contained in a medical bag into a plurality of sampling containers via a collection kit, the collection kit comprising an inflow tube to which the medical bag is connected, and a collection bag connected downstream of the inflow tube and formed by welding two flexible sheets together, the collection bag comprising a plurality of storage chambers for storing the collection objects, a single outflow port for transferring the collection objects from the plurality of storage chambers to the plurality of sampling containers, respectively, at least one exhaust section for exhausting air from the plurality of storage chambers, a single main flow path connecting the inflow tube and the outflow port, a plurality of connecting flow paths provided between the main flow path and the plurality of storage chambers and connecting each of the storage chambers to the main flow path, and a plurality of connecting flow paths connected to the main flow path. a connecting portion, an inlet-side flow path that is provided in the main flow path and connects the connecting portion to the inlet tube, and an outlet-side flow path that is provided in the main flow path and connects the connecting portion to the outlet port, and the collection method includes a connecting step of connecting the medical bag to the inlet tube; an introducing step of introducing the collection object that has moved from the medical bag to the inside of the collection bag through the inlet tube and the inlet-side flow path into each of the multiple storage chambers through the multiple connecting flow paths; a separating step of separating the medical bag from the inlet tube after introducing the collection object into each of the multiple storage chambers; and a collection step of sequentially connecting the multiple sampling containers to the outlet port and selectively closing and opening the multiple connecting flow paths to sequentially transfer the collection object from the multiple storage chambers to the multiple sampling containers.
[0026] This collection method includes an inlet tube to which a medical bag is connected, thereby improving work efficiency when collecting samples into multiple sampling containers. Furthermore, since multiple storage chambers can each store samples, it is possible to collect a predetermined amount of sample. By providing a single outlet port for sequentially collecting samples into multiple sampling containers, a collection kit with multiple storage chambers can be manufactured with a simple structure and at low cost.
[0027] According to the present invention, the collection bag includes a single main flow path connecting the inlet tube and the outlet port, and multiple connecting flow paths provided between the main flow path and multiple storage chambers, connecting each of the storage chambers to the main flow path. The collection bag also includes an inlet tube to which a medical bag is connected. This improves work efficiency when collecting samples into multiple sampling containers. Furthermore, since each of the multiple storage chambers can accommodate a sample, a predetermined amount of sample can be collected. By providing a single outlet port for sequentially collecting samples into multiple sampling containers, a collection kit with multiple storage chambers can be produced with a simple structure and at low cost.
[0028] FIG. 1 is a schematic front view of a collection kit according to a first embodiment of the present invention. FIG. 2 is an explanatory diagram of the collection kit of FIG. 1 connected to a medical bag. FIG. 3 is an enlarged plan view of a flow path switching unit in the collection kit. FIG. 4 is a cross-sectional view taken along line IV-IV in FIG. 3. FIG. 5 is an explanatory diagram of transferring a collection object from a first storage chamber to a first sampling container. FIG. 6 is an explanatory diagram showing the first position of the flow path switching unit in FIG. 5. FIG. 7 is an explanatory diagram of transferring a collection object from a second storage chamber to a second sampling container. FIG. 8 is an explanatory diagram showing the second position of the flow path switching unit in FIG. 7. FIG. 9 is a cross-sectional view showing the main flow path blocked by the flow path switching unit. FIG. 10 is a schematic front view of a collection kit according to a modified embodiment of the present invention. FIG. 11 is a schematic front view of a collection kit according to a second embodiment of the present invention. FIG. 12 is an enlarged plan view of the flow path switching unit in the collection kit. FIG. 13A is a cross-sectional view taken along line XIIIA-XIIIA in FIG. 12. Fig. 13B is a cross-sectional view taken along line XIIIB-XIIIB in Fig. 12. Fig. 14 is an exploded perspective view of the flow path switching unit and collection bag. Fig. 15 is a cross-sectional view taken along line XV-XV in Fig. 12. Fig. 16 is a first explanatory diagram showing the switching state of the flow path switching unit. Fig. 17 is a cross-sectional view taken along line XVII-XVII in Fig. 16. Fig. 18 is a second explanatory diagram showing the switching state of the flow path switching unit. Fig. 19 is a cross-sectional view taken along line XIX-XIX in Fig. 18. Fig. 20 is a third explanatory diagram showing the switching state of the flow path switching unit.
[0029] As shown in FIG. 1 , the collection kit 10 according to the first embodiment is used to transfer a collection target M contained in a medical bag 12 shown in FIG. 2 to multiple sampling containers 14 (see FIGS. 5 and 7 ). The collection target M is, for example, a blood product such as a platelet product. The collection target M may also be a pharmaceutical product other than a blood product. The collection target M may also be a liquid sample other than a pharmaceutical product. The medical bag 12 may also be a blood bag system for centrifuging blood containing multiple components into multiple components with different specific gravities (e.g., three components: a light component, a medium component, and a heavy component, or two components: a light component and a heavy component), and storing and storing each component in a separate bag. In this case, the collection kit 10 may be connected to the blood bag system.
[0030] As shown in FIG. 1 , the collection kit 10 includes an inflow tube 16 to which a medical bag 12 (see FIG. 2 ) is connected, a collection bag 18, an adapter 20, and a flow path switching unit 22. The adapter 20 may be detachable from the collection bag 18. Hereinafter, the extension direction of the inflow tube 16 (arrow V direction) in the collection kit 10 shown in FIG. 1 will be referred to as the up-down direction. The direction perpendicular to the up-down direction (arrow W direction) will be referred to as the width direction of the collection kit 10, and the direction perpendicular to the up-down direction and the width direction will be referred to as the thickness direction of the collection kit 10. The collection kit 10 is generally used with the up-down direction aligned vertically.
[0031] The inflow tube 16 is a transparent or translucent medical tube. The inflow tube 16 is made of a thermoplastic resin such as polyvinyl chloride resin. The inflow tube 16 can be connected to or disconnected from other medical tubes without exposing the inside to the outside air by using a sterile connection device or a tube sealer.
[0032] The inflow tube 16 has an upstream end 16a and a downstream end 16b. When the collection kit 10 is initially provided as a product, the upstream end 16a is welded and sealed. The downstream end 16b is connected to the upper edge 181 of the collection bag 18 via a relay member 24. The relay member 24 is, for example, a sleeve made of a material harder than the collection bag 18.
[0033] The collection bag 18 is connected downstream of the inflow tube 16. The collection bag 18 has two flexible sheets 26 that are overlapped and welded together in the thickness direction. The collection bag 18 has multiple storage chambers 28, a single main flow path 30, an exhaust flow path 32, multiple connecting flow paths 34, a single outlet port 36 (see FIG. 3 ), an exhaust section 38, and a cutout section 40. The main flow path 30, the exhaust flow path 32, the multiple connecting flow paths 34, and the multiple storage chambers 28 are disposed between the two flexible sheets 26 and each bulge in the thickness direction of the collection bag 18.
[0034] The collection bag 18 has a first region 18R and a second region 18L. The first region 18R is located to the right of the width center of the collection bag 18. The second region 18L is located to the left of the width center of the collection bag 18.
[0035] The multiple storage chambers 28 store the collection target objects M (see FIG. 2). The multiple storage chambers 28 include a first storage chamber 281 and a second storage chamber 282. The first storage chamber 281 has an elliptical shape that is elongated in the vertical direction of the collection bag 18. The first storage chamber 281 is provided in the first region 18R. The volume of the first storage chamber 281 is, for example, approximately 8 mL to approximately 10 mL. The first storage chamber 281 temporarily stores the collection target objects M collected in the first sampling container 141 (see FIG. 5). Note that the multiple storage chambers 28 are not limited to two storage chambers 28. The multiple storage chambers 28 may be composed of three or more storage chambers 28.
[0036] The second storage chamber 282 has an elliptical shape that is elongated in the vertical direction of the collection bag 18. The second storage chamber 282 is provided in the second region 18L. The volume of the second storage chamber 282 is, for example, approximately 8 mL to approximately 10 mL. The volume of the second storage chamber 282 is the same as the volume of the first storage chamber 281. The second storage chamber 282 temporarily stores the collection target M to be collected in the second sampling container 142 (see FIG. 7). Note that each of the first storage chamber 281 and the second storage chamber 282 is not limited to being formed in an elliptical shape. Each of the first storage chamber 281 and the second storage chamber 282 may have a shape other than an elliptical shape. Furthermore, the volume of the first storage chamber 281 and the volume of the second storage chamber 282 may be different.
[0037] The main flow channel 30 connects the inlet tube 16 and the outlet port 36. The main flow channel 30 is located at the center of the collection bag 18 in the width direction. The main flow channel 30 is located between the first region 18R and the second region 18L and extends in the vertical direction. The main flow channel 30 has an inlet-side flow channel 301 and an outlet-side flow channel 302 (see FIG. 3 ). As shown in FIG. 3 , the inlet-side flow channel 301 connects the inlet tube 16 to a connecting portion 44 (described later). As shown in FIG. 1 , the upper end of the inlet-side flow channel 301 is provided at the upper end of the collection bag 18 and connected to the inlet tube 16 via a relay member 24. As shown in FIG. 3 , the outlet-side flow channel 302 connects the connecting portion 44 (described later) to the outlet port 36. The lower end of the outlet-side flow channel 302 is provided at the lower end of the collection bag 18 and connected to the outlet port 36 via a connecting portion 44. The inlet flow channel 301 and the outlet flow channel 302 are provided linearly in the vertical direction (direction of arrow V) of the collection bag 18 .
[0038] 1 , the exhaust flow path 32 is provided in each of the first region 18R and the second region 18L of the collection bag 18. The exhaust flow path 32 is connected to the top of the first storage chamber 281 and the second storage chamber 282, respectively. The upper end of the exhaust flow path 32 is located on the upper edge portion 181 of the collection bag 18 and is connected to the exhaust section 38.
[0039] The plurality of connection flow paths 34 are provided between the first storage chamber 281 and the second storage chamber 282 and the main flow path 30. The plurality of connection flow paths 34 connect each of the first storage chamber 281 and the second storage chamber 282 to the main flow path 30. The plurality of connection flow paths 34 include a first connection flow path 341 and a second connection flow path 342. The first connection flow path 341 is provided in the first region 18R of the collection bag 18. The first connection flow path 341 extends in the width direction of the collection bag 18 and is connected to the main flow path 30. The first connection flow path 341 is connected to a lower portion of the first storage chamber 281. The first connection flow path 341 connects the main flow path 30 and the first storage chamber 281. The first connection flow path 341 is inclined upward from the main flow path 30 toward the first storage chamber 281.
[0040] The second connection flow path 342 is provided in the second region 18L of the collection bag 18. The second connection flow path 342 extends in the width direction of the collection bag 18 and is connected to the main flow path 30. The second connection flow path 342 is connected to a lower part of the second storage chamber 282. The second connection flow path 342 connects the main flow path 30 and the second storage chamber 282. The second connection flow path 342 is inclined upward from the main flow path 30 toward the second storage chamber 282.
[0041] The collection bag 18 further includes a connection portion 44. The connection portion 44 connects the first connection flow path 341 and the second connection flow path 342 to the main flow path 30. In a plan view of the collection bag 18 in the thickness direction, the connection portion 44 is generally cross-shaped. The inlet-side flow path 301 is disposed above the connection portion 44, and the inlet-side flow path 301 is disposed so as to face upward relative to the connection portion 44. The outlet-side flow path 302 is disposed below the connection portion 44, and the outlet-side flow path 302 is disposed so as to face downward relative to the connection portion 44. The first connection flow path 341 extends from the connection portion 44 in one direction in the width direction. The second connection flow path 342 extends from the connection portion 44 in the other direction in the width direction.
[0042] The outlet port 36 is provided in the outlet-side flow path 302 of the main flow path 30. The outlet port 36 is provided to transfer the collection target material M from the first storage chamber 281 and the second storage chamber 282 to the first sampling container 141 and the second sampling container 142 (see FIGS. 5 and 7), respectively.
[0043] 1 , the exhaust unit 38 is provided to exhaust air from the first storage chamber 281 and the second storage chamber 282. The exhaust unit 38 has a first exhaust unit 381 and a second exhaust unit 382. The first exhaust unit 381 is connected to the upper end of the exhaust flow path 32 that communicates with the first storage chamber 281 via an attachment member 46. The second exhaust unit 382 is connected to the upper end of the exhaust flow path 32 that communicates with the second storage chamber 282 via the attachment member 46. The attachment member 46 provides a liquid-tight and airtight seal between the collection bag 18 and each of the first exhaust unit 381 and the second exhaust unit 382.
[0044] The first exhaust section 381 and the second exhaust section 382 each have a filter 48 that allows gas to pass through but prevents liquid from passing through. When the main component of the collection target M is water, the filter 48 is preferably a hydrophilic filter. In this case, when the collection target M moves to the filter 48 through the exhaust flow path 32 and comes into contact with the filter 48, the pores of the filter 48 are blocked by the liquid. After the pores of the filter 48 are blocked, the filter 48 prevents gas and liquid from passing through. This prevents leakage of the collection target M from the first storage chamber 281 and the second storage chamber 282 to the outside. An example of a collection target M whose main component is water is a blood product.
[0045] The exhaust unit 38 is not limited to a configuration in which it is connected to the upper end of the exhaust flow path 32 via the mounting member 46. For example, a filter 48a may be provided on the flexible sheet 26 of the collection bag 18 (see the two-dot chain line in FIG. 1 ). In this case, the filter 48a is disposed on a wall of the flexible sheet 26 that faces the first storage chamber 281 and the second storage chamber 282, and the air in the first storage chamber 281 and the second storage chamber 282 can be directly exhausted to the atmosphere through the filter 48a.
[0046] As shown in FIG. 3 , the cutout 40 is formed by cutting a portion of the flexible sheet 26 in the thickness direction of the collection bag 18. The cutout 40 is disposed so as to surround the connection portion 44. That is, the cutout 40 is disposed at the center of the width direction of the collection bag 18 and from the center in the up-down direction to the bottom. The cutout 40 has a first upper hole 401U and a second upper hole 402U, and a first lower hole 401L and a second lower hole 402L. The first upper hole 401U and the first lower hole 401L are disposed in the first region 18R. The first upper hole 401U is surrounded by the first storage chamber 281, the inlet-side flow path 301 of the main flow path 30, and the first connecting flow path 341. The first lower hole 401L is disposed below the first upper hole 401U, with the first connecting flow path 341 between them. The first lower hole portion 401L is surrounded by the outlet-side flow path 302 of the main flow path 30 , the first connecting flow path 341 , and the lower side portion 182 of the collection bag 18 .
[0047] The second upper hole 402U and the second lower hole 402L are provided in the second region 18L. The second upper hole 402U is surrounded by the second storage chamber 282, the inlet-side flow path 301 of the main flow path 30, and the second connecting flow path 342. The second lower hole 402L is disposed below the second upper hole 402U, with the second connecting flow path 342 interposed therebetween. The second lower hole 402L is surrounded by the outlet-side flow path 302 of the main flow path 30, the second connecting flow path 342, and the lower edge 182 of the collection bag 18.
[0048] As shown in Figure 1, the adapter 20 is connected to the lower end of the outlet flow path 302 of the main flow path 30 via a connecting member 42. The adapter 20 is arranged so as to protrude downward from the lower edge 182 of the collection bag 18. The adapter 20 has an adapter main body 50 and a communicating tube 52 provided at the upper end of the adapter main body 50. The communicating tube 52 is inserted into the inner hole of the connecting member 42, thereby connecting the adapter 20 to the main flow path 30. The connecting member 42 provides a liquid-tight and airtight seal between the communicating tube 52 and the collection bag 18.
[0049] The adapter 20 includes a needle tube 54 and a rubber cover 56 that covers the needle tube 54. The needle tube 54 is provided inside the adapter body 50 and is connected to a communicating tube 52. When the neck of the sampling container 14 is inserted into the adapter body 50, the needle tube 54 penetrates the stopper (not shown) of the sampling container 14 (see FIGS. 5 and 7). When the connecting member 42 is opened, the sampling container 14 and the outlet flow path 302 of the main flow path 30 are connected via the communicating tube 52 and the needle tube 54.
[0050] When the needle tube 54 is inserted into the stopper of the sampling container 14, the rubber cover 56 is compressed by being pushed toward the collection bag 18. The needle tube 54 penetrates the compressed rubber cover 56. When the needle tube 54 is removed from the stopper of the sampling container 14, the rubber cover 56 stretches due to its elastic restoring force and covers the needle tube 54 again.
[0051] The flow path switching unit 22 selectively connects either the first connection flow path 341 or the second connection flow path 342 to the outlet flow path 302 of the main flow path 30. As shown in Figure 3, the flow path switching unit 22 is provided in the cutout portion 40 of the collection bag 18 and faces the connection portion 44. The flow path switching unit 22 includes a housing 58, a cover member 60, and a switching member 62.
[0052] The housing 58 rotatably holds the switching member 62. In a plan view of the flow path switching unit 22, the housing 58 is formed in a rectangular shape. As shown in FIG. 4 , the housing 58 has side walls 581 arranged on all four sides and a bottom wall 582. Each side wall 581 has a recess 584. Each recess 584 is recessed from one end of the side wall 581 toward the bottom wall 582. The bottom wall 582 is surrounded by the other ends of each side wall 581. The bottom wall 582 has a pedestal 585. The pedestal 585 protrudes in an annular shape from the bottom wall 582.
[0053] As shown in FIG. 3 , a portion of the collection bag 18 is housed inside the housing 58. The connection portion 44 of the collection bag 18 is housed inside the housing 58. The side wall 581 of the housing 58 is disposed below the cutout portion 40 and the bottom edge portion 182 of the collection bag 18 (see FIG. 3 ). The connection portion 44 of the collection bag 18 is housed in the center of the housing 58. The inlet flow path 301, the outlet flow path 302, the first connecting flow path 341, and the second connecting flow path 342 of the main flow path 30 are disposed in each recess 584. Portions of the side wall 581 of the housing 58 are disposed in the first upper hole 401U and the second upper hole 402U, and the first lower hole 401L and the second lower hole 402L of the cutout portion 40. The cutout portion 40 prevents contact between the side wall 581 of the housing 58 and the collection bag 18.
[0054] As shown in FIG. 4 , the cover member 60 is attached to the side wall 581 of the housing 58 to close the opening. The connection portion 44 of the collection bag 18 is housed between the cover member 60 and the housing 58. The cover member 60 has a lid portion 601, a support shaft 602, and a guide portion 603. As shown in FIG. 3 , the lid portion 601 is rectangular in plan view of the cover member 60. As shown in FIG. 4 , the lid portion 601 is formed in a plate shape. The support shaft 602 is provided at the center of the lid portion 601 and protrudes from the lid portion 601. The axial direction of the support shaft 602 and the lid portion 601 are approximately perpendicular. The outer peripheral surface of the support shaft 602 has multiple protrusions 604. The multiple protrusions 604 are provided at the tip of the support shaft 602. The multiple protrusions 604 are arranged circumferentially on the outer peripheral surface of the support shaft 602 (see FIG. 3 ). The plurality of protrusions 604 protrude radially outward from the outer circumferential surface of the support shaft 602. The plurality of protrusions 604 are formed in a tapered shape toward the tip of the support shaft 602.
[0055] The guide portion 603 includes an annular wall 605 and a guide groove 606. The annular wall 605 is annular and centered on the support shaft 602. The annular wall 605 protrudes from the lid portion 601 along the axial direction of the support shaft 602. The guide groove 606 penetrates the lid portion 601 inside the annular wall 605. As shown in FIG. 3 , the guide groove 606 has a first groove portion 606A and a second groove portion 606B. The first groove portion 606A and the second groove portion 606B are arc-shaped with a radius centered on the support shaft 602. The first groove portion 606A and the second groove portion 606B are spaced apart in the circumferential direction centered on the support shaft 602. The length of the first groove portion 606A in the circumferential direction is longer than the length of the second groove portion 606B in the circumferential direction.
[0056] The switching member 62 is rotatably provided relative to the collection bag 18. The switching member 62 is rotatably provided inside the annular wall 605 of the cover member 60. As shown in Figure 4, the switching member 62 is movably provided in the thickness direction of the collection bag 18 relative to the housing 58. The switching member 62 has a main body portion 621, an operating portion 622, and a blocking portion 623.
[0057] The main body 621 is disk-shaped (see FIG. 3 ). The main body 621 is housed inside the annular wall 605. The main body 621 has an insertion hole 625 at its center, into which the support shaft 602 is inserted. The operating portion 622 is gripped by a user when rotating the switching member 62 of the flow path switching unit 22. The operating portion 622 protrudes axially from a first surface 6211 of the main body 621. As shown in FIG. 3 , the operating portion 622 extends linearly in the radial direction of the main body 621, passing through the center of the main body 621. Both ends of the operating portion 622 extend to the vicinity of the outer circumferential surface of the main body 621. For example, a user-recognizable mark 624 is provided on one end of the operating portion 622 (see FIG. 1 ). As shown in FIG. 4 , the insertion hole 625 of the main body 621 extends from the main body 621 to a portion of the operating portion 622. The support shaft 602 of the cover member 60 is inserted into the insertion hole 625. The switching member 62 is rotatably supported relative to the cover member 60. The main body 621 is provided so as to be movable along the axial direction of the support shaft 602. The axial direction of the support shaft 602 is the thickness direction of the collection bag 18 when the flow path switching unit 22 is attached to the collection bag 18.
[0058] The insertion hole 625 has an engagement recess 626. The engagement recess 626 expands radially outward and is capable of engaging with the protrusion 604 of the support shaft 602. The engagement recess 626 is annular and extends in the circumferential direction of the insertion hole 625.
[0059] As shown in Fig. 3, the blocking portion 623 is provided so as to be able to selectively block either the first connection flow path 341 or the second connection flow path 342. As shown in Fig. 4, the blocking portion 623 is provided on a second surface 6212 opposite to the first surface 6211 of the main body portion 621. The blocking portion 623 includes a first blocking piece 6231 and a second blocking piece 6232.
[0060] The first blocking piece 6231 and the second blocking piece 6232 protrude in the axial direction from the second surface 6212. As shown in FIG. 3 , each of the first blocking piece 6231 and the second blocking piece 6232 has an arc shape with a radius centered on the axis of the main body 621. The first blocking piece 6231 and the second blocking piece 6232 are spaced apart in the circumferential direction of the switching member 62. The length of the first blocking piece 6231 in the circumferential direction is longer than the length of the second blocking piece 6232 in the circumferential direction. In a plan view of the switching member 62, the center of the length of the first blocking piece 6231 and the other end of the operating portion 622 are aligned. The second blocking piece 6232 and one end of the operating portion 622 are aligned. The first blocking piece 6231 is inserted into the first groove 606A. The second blocking piece 6232 is inserted into the second groove 606B. In the circumferential direction of the switching member 62, the length of the second groove portion 606B is longer than the length of the second blocking piece 6232. When the switching member 62 rotates with respect to the cover member 60, the first blocking piece 6231 is movable along the first groove portion 606A, and the second blocking piece 6232 is movable along the second groove portion 606B. As shown in FIG. 4 , the first blocking piece 6231 and the second blocking piece 6232 face the base 585 of the housing 58.
[0061] By selecting the rotational position of the switching member 62, one of the first connection flow path 341 and the second connection flow path 342 can be blocked by the first blocking piece 6231 of the blocking unit 623. Specifically, in the plan view of the switching member 62 shown in Fig. 5 , when the switching member 62 is rotated in a first direction from the initial position, it is placed in the first position of the flow path switching unit 22, as shown in Fig. 6 , and the first blocking piece 6231 faces the inlet flow path 301 and the second connection flow path 342 of the main flow path 30. The second blocking piece 6232 is disposed in the notch 40 (first lower hole portion 401L) between the first connection flow path 341 and the outlet flow path 302.
[0062] In the plan view of the switching member 62 shown in Fig. 7 , when the switching member 62 is rotated from the initial position in a second direction opposite to the first direction, the flow path switching unit 22 assumes the second position as shown in Fig. 8 , and the first blocking piece 6231 faces the inlet flow path 301 and the first connecting flow path 341 of the main flow path 30. The second blocking piece 6232 is disposed in the notch 40 (second lower hole 402L) between the second connecting flow path 342 and the outlet flow path 302.
[0063] The switching member 62 is rotatably supported via a support shaft 602, and is also supported axially movably via the support shaft 602. As shown in Fig. 4, in the open position where the blocking portion 623 of the switching member 62 is separated from the seat 585 of the housing 58, the first connection flow path 341 and the second connection flow path 342, the main flow path 30, and the blocking portion 623 are separated and in an open, communicating state.
[0064] 9 , when the user pushes the switching member 62 toward the base 585 in the thickness direction of the collection bag 18, the switching member 62 moves along the support shaft 602 toward the base 585 of the housing 58 to reach the blocking position. At the blocking position, the blocking portion 623 approaches the base 585, and the main flow path 30 and the like are sandwiched between the blocking portion 623 and the base 585, resulting in a blocked state in which the main flow path 30 is closed.
[0065] In the initial position of the flow path switching unit 22 shown in Fig. 3, the inlet-side flow path 301 of the main flow path 30 is blocked by movement of the switching member 62 toward the pedestal 585. In the first position of the flow path switching unit 22 shown in Fig. 6, the second connection flow path 342 and the inlet-side flow path 301 are blocked by movement of the switching member 62 toward the pedestal 585. In the second position of the flow path switching unit 22 shown in Fig. 8, the first connection flow path 341 and the inlet-side flow path 301 are blocked by movement of the switching member 62 toward the pedestal 585.
[0066] In another embodiment of the collection kit 10, when the flow path switching unit 22 is in the first position, the first blocking piece 6231 may block only the second connection flow path 342. When the flow path switching unit 22 is in the second position, the first blocking piece 6231 may block only the first connection flow path 341.
[0067] Next, a collection method for separating the collection target M into the first sampling container 141 and the second sampling container 142 using the collection kit 10 according to the first embodiment will be described.
[0068] 2, a connection step is performed to connect the medical bag 12 to the inflow tube 16. The user connects the medical bag 12 containing the collection object M, such as a platelet preparation, to the inflow tube 16. At this time, the medical bag 12 is positioned above the collection bag 18. The user joins the supply tube 64 of the medical bag 12 to the inflow tube 16.
[0069] Next, an introduction step is performed in which the collection target M, which has moved from the medical bag 12 through the inflow tube 16 and the inflow-side flow path 301 into the inside of the collection bag 18, is introduced into the first storage chamber 281 and the second storage chamber 282 through the first connecting flow path 341 and the second connecting flow path 342, respectively. Before transferring the collection target M to the first storage chamber 281, the user sets the switching member 62 of the flow path switching unit 22 to the initial position, as shown in FIG. 3 . The initial position is a position in which the switching member 62 is disposed in a direction away from the housing 58 in the thickness direction of the collection bag 18, and the first blocking piece 6231 faces the inflow-side flow path 301 of the main flow path 30, and the second blocking piece 6232 faces the outflow-side flow path 302 of the main flow path 30. As shown in FIG. 4 , in the initial position, the first blocking piece 6231 and the second blocking piece 6232 are spaced apart from the main flow path 30 in the thickness direction of the collection bag 18, representing an open position in which communication with the main flow path 30 is not blocked. Therefore, the inlet side flow path 301 communicates with the first connecting flow path 341 and the second connecting flow path 342 via the connecting portion 44 .
[0070] The collection target M is, for example, a liquid and is flowable. Therefore, as shown in Fig. 2, the collection target M flows out of the medical bag 12 by gravity and flows into the inlet-side flow path 301 of the main flow path 30 via the supply tube 64 and the inlet tube 16. The collection target M moves downward from the inlet tube 16 along the inlet-side flow path 301 by gravity. The collection target M is diverted into the first connection flow path 341 and the second connection flow path 342 at the connection part 44 and flows into the first storage chamber 281 and the second storage chamber 282 via the first connection flow path 341 and the second connection flow path 342.
[0071] When the collection target M flows into the first storage chamber 281, the air remaining in the first storage chamber 281 is discharged from the exhaust flow path 32 to the atmosphere through the first exhaust part 381. When the collection target M flows into the second storage chamber 282, the air remaining in the second storage chamber 282 is discharged from the exhaust flow path 32 to the atmosphere through the second exhaust part 382.
[0072] After the first storage chamber 281 and the second storage chamber 282 are filled with the collection target M, the collection target M flows into the filter 48 of the first exhaust section 381 and the second exhaust section 382 via the exhaust flow path 32. When the collection target M comes into contact with the filter 48, the collection target M is captured and held in the pores of the filter 48. This causes the filter 48 to block the collection target M within the first exhaust section 381 and the second exhaust section 382. As a result, the first exhaust section 381 and the second exhaust section 382 are closed, preventing the collection target M from passing through the filter 48 and being discharged to the outside. A required amount (e.g., approximately 8 mL to approximately 10 mL) of collection target M is stored in each of the first storage chamber 281 and the second storage chamber 282. The supply of collection target M from the medical bag 12 to the collection bag 18 stops.
[0073] Next, a separation step is performed to separate the medical bag 12 from the inflow tube 16. At the same time as the inflow tube 16 is separated from the supply tube 64 of the medical bag 12, the upstream end 16a of the inflow tube 16 is sealed by welding. A tube sealer such as a high-frequency sealer or an ultrasonic sealer is used to seal the inflow tube 16. The medical bag 12 separated from the collection kit 10 is stored until the test is completed.
[0074] Next, the first sampling container 141 and the second sampling container 142 are sequentially connected to the outlet port 36, and the first connecting flow path 341 and the second connecting flow path 342 are selectively closed and opened, thereby carrying out a collection step in which the collection target M is sequentially transferred from the first storage chamber 281 and the second storage chamber 282 to the first sampling container 141 and the second sampling container 142. Below, a case will be described in which the collection target M in the first storage chamber 281 is transferred to the first sampling container 141, and then the collection target M in the second storage chamber 282 is transferred to the second sampling container 142.
[0075] The transfer of the collection target object M is not limited to the case where the transfer is performed in the order of the first sampling container 141 and then the second sampling container 142. For example, the collection target object M in the second storage chamber 282 may be transferred to the second sampling container 142, and then the collection target object M in the first storage chamber 281 may be transferred to the first sampling container 141.
[0076] First, a step of transferring the collection target M in the first storage chamber 281 to the first sampling container 141 is performed. The user grasps the operating portion 622 of the switching member 62 and rotates the switching member 62 from the initial position to the first position (see FIG. 5 ). As shown in FIG. 6 , when the switching member 62 is in the first position, the first blocking piece 6231 faces the second connection flow path 342 and the inflow-side flow path 301, and the second blocking piece 6232 is positioned between the first connection flow path 341 and the outflow-side flow path 302. After rotating the switching member 62 to the first position, the user pushes the switching member 62 toward the housing 58 to set it to the blocking position.
[0077] In the blocking position, the switching member 62 moves axially along the support shaft 602 toward the housing 58. The main body 621 of the switching member 62 is housed inside the annular wall 605 of the guide portion 603 (see FIG. 9 ). The first blocking piece 6231 moves toward the main flow path 30 and the second connecting flow path 342, and the first blocking piece 6231 presses the main flow path 30 and the second connecting flow path 342 toward the base 585. The main flow path 30 and the second connecting flow path 342 are crushed and deformed between the first blocking piece 6231 and the base 585, and the inlet-side flow path 301 of the main flow path 30 and the second connecting flow path 342 are blocked. As shown in FIG. 9 , after the switching member 62 moves along the support shaft 602, the protrusion 604 of the support shaft 602 engages with the engagement recess 626, preventing axial movement of the switching member 62 relative to the support shaft 602. The switching member 62 is locked in the blocking position where it has moved toward the housing 58. In the blocking position, the first connecting flow path 341 and the outlet flow path 302 of the main flow path 30 are in communication with each other through the connection part 44. The first storage chamber 281 and the outlet flow path 302 are in communication with each other through the first connecting flow path 341.
[0078] As shown in Figure 5, the first sampling container 141 is connected to the adapter 20. The lid 66 of the adapter 20 is opened, and the neck of the first sampling container 141 is inserted into the adapter body 50. This causes the needle tube 54 provided inside the adapter body 50 to pierce the stopper of the first sampling container 141.
[0079] The user bends the plug of the connecting member 42 to break it, opening the outlet flow path 302 of the main flow path 30. The collection target M in the first storage chamber 281 is sucked out by the negative pressure in the first sampling container 141, passes through the first connecting flow path 341, the outlet flow path 302, the outlet port 36, the connecting member 42, the communicating tube portion 52 of the adapter 20, and the needle tube 54, and flows into the first sampling container 141. At this time, because the flow path switching unit 22 blocks communication between the second connecting flow path 342 and the outlet flow path 302, the collection target M in the second storage chamber 282 is not sucked out through the outlet flow path 302. As a result, substantially the entire amount of the collection target M stored in the first storage chamber 281 is transferred to the first sampling container 141. The amount of the collection target M in the first sampling container 141 is, for example, approximately 8 mL to 10 mL.
[0080] After removing the first sampling container 141 from the adapter 20, as shown in Figure 7, a step is performed in which the second sampling container 142 is connected to the adapter 20 and the sample target M in the second storage chamber 282 is transferred to the second sampling container 142. The connection of the second sampling container 142 is the same as when connecting the first sampling container 141, so a detailed description of the connection between the adapter 20 and the second sampling container 142 will be omitted.
[0081] After connecting the second sampling container 142, the switching member 62 of the flow path switching unit 22 is rotated to the second position, as shown in FIG. 8 . The second position is achieved by rotating the switching member 62 in the opposite direction to that used when switching from the initial position to the first position. In the second position of the flow path switching unit 22, the first blocking piece 6231 faces the first connecting flow path 341 and the inlet flow path 301, and the second blocking piece 6232 is positioned between the second connecting flow path 342 and the outlet flow path 302. In the second position, the switching member 62 remains in the blocking position, pushed toward the housing 58 (see FIG. 9 ).
[0082] By setting the switching member 62 to the second position, the first blocking piece 6231 presses the main flow path 30 and the first connecting flow path 341 toward the base 585. The main flow path 30 and the first connecting flow path 341 are crushed between the first blocking piece 6231 and the base 585, and the inlet-side flow path 301 and the first connecting flow path 341 of the main flow path 30 are blocked. Meanwhile, the second connecting flow path 342 is opened, and the second connecting flow path 342 and the outlet-side flow path 302 of the main flow path 30 communicate with each other through the connecting part 44.
[0083] By setting the switching member 62 of the flow path switching unit 22 to the second position, the collection target M in the second storage chamber 282 is sucked out by the negative pressure in the second sampling container 142. The collection target M passes from the second storage chamber 282 through the second connecting flow path 342, the outlet flow path 302, the outlet port 36, the connecting member 42, the communicating tube 52 of the adapter 20, and the needle tube 54, and flows into the second sampling container 142. As a result, substantially the entire amount of the collection target M stored in the second storage chamber 282 is transferred to the second sampling container 142. The amount of the collection target M in the second sampling container 142 is, for example, approximately 8 mL to approximately 10 mL. The adapter 20 is then removed from the second sampling container 142. This completes the collection (sampling) of the collection target M using the collection kit 10. That is, the first sample MS1 is introduced into the first sampling container 141, and the second sample MS2 is introduced into the second sampling container 142.
[0084] If the collection target M is a blood product, a culture test is performed on the first sample MS1 and the second sample MS2. Specifically, the first sample MS1 in the first sampling container 141 is used, for example, for anaerobic culture to observe whether anaerobic bacteria grow. The second sample MS2 in the second sampling container 142 is used, for example, for aerobic culture to observe whether aerobic bacteria grow. In both tests, the first sampling container 141 and the second sampling container 142 are used as culture bottles. If the first sample MS1 and the second sample MS2 pass the culture test, the collection target M in the medical bag 12 from which the first sample MS1 and the second sample MS2 were collected is determined to be an acceptable product. The acceptable product is used for patient treatment (such as blood transfusion).
[0085] When using the sampling kit 10 to separate the sampling target M into the first sampling container 141 and the second sampling container 142, a sampling kit jig (not shown) may be used.
[0086] The collection kit 10 is not limited to a configuration including a flow path switching unit 22. For example, the collection kit 101 according to a modified example shown in Fig. 10 does not include a flow path switching unit 22 at the connection unit 44, which is the connection portion between the first connection flow path 341 and the second connection flow path 342 and the main flow path 30. For example, a closure member (not shown), such as a clamp, may be provided on each of the first connection flow path 341 and the second connection flow path 342, and either one of the first connection flow path 341 and the second connection flow path 342 may be selectively connected to the outlet flow path 302 of the main flow path 30 by appropriately opening and closing the two closure members.
[0087] The first embodiment has the following advantages.
[0088] As shown in FIG. 1 , the collection bag 18 includes a single main flow path 30 connecting the inlet tube 16 and the outlet port 36, and multiple connection flow paths 34 (first connection flow path 341, second connection flow path 342) between the main flow path 30 and multiple storage chambers 28 (first storage chamber 281, second storage chamber 282) and connecting each of the storage chambers 28 to the main flow path 30. The inlet tube 16 to which the medical bag 12 is connected improves the efficiency of collecting samples M into multiple sampling containers 14 (see FIGS. 5 and 7 ). Furthermore, since each of the multiple storage chambers 28 can accommodate a sample M, a predetermined amount of sample M can be collected. The inclusion of a single outlet port 36 for sequentially collecting samples into multiple sampling containers 14 allows the collection kit 10 having multiple storage chambers 28 to have a simple structure and at low cost.
[0089] 3, the collection bag 18 has a connection part 44 that connects the multiple connection flow paths 34 and the main flow path 30, and the main flow path 30 has an inlet side flow path 301 that connects the connection part 44 and the inflow tube 16, and an outlet side flow path 302 that connects the connection part 44 and the outlet port 36. The collection kit 10 includes a flow path switching part 22 that selectively connects one of the multiple connection flow paths 34 to the outlet side flow path 302.
[0090] This allows the flow path switching unit 22 to easily switch the communication between any one of the plurality of storage chambers 28 and the outlet-side flow path 302 via the connection flow path 34.
[0091] The collection bag 18 has a cutout 40 formed by cutting out a part of the flexible sheet 26 in the thickness direction of the collection bag 18 so as to surround the connection part 44 , and the flow path switching part 22 is provided in the cutout 40 .
[0092] As a result, by placing the flow path switching unit 22 in the cutout portion 40, it is possible to attach the flow path switching unit 22 without crushing the multiple storage chambers 28 and the main flow path 30 in the flexible sheet 26 in the thickness direction.
[0093] The flow path switching unit 22 includes a switching member 62 that is rotatable relative to the collection bag 18, and the switching member 62 has a blocking portion 623 that selectively blocks one of the plurality of connection flow paths 34. By selecting the rotation position of the switching member 62, one of the plurality of connection flow paths 34 can be blocked by the blocking portion 623. As a result, by rotating the switching member 62, it is possible to effectively switch the communication state between one of the plurality of connection flow paths 34 and the outlet-side flow path 302.
[0094] 4 , the flow path switching unit 22 has a housing 58 that rotatably holds a switching member 62, and the switching member 62 is provided so as to be movable in the thickness direction of the collection bag 18 relative to the housing 58. When the switching member 62 moves toward the connection flow path 34 in the thickness direction of the collection bag 18, the blocking portion 623 presses the connection flow path 34 toward the housing 58. As a result, when the flow path switching unit 22 switches the open / closed state of the connection flow path 34, the blocking portion 623 is pressed against the connection flow path 34, thereby effectively blocking the connection flow path 34.
[0095] 9 , the blocking portion 623 of the switching member 62 can block the inflow-side flow path 301. By selecting the rotational position of the switching member 62, the blocking portion 623 can block one of the plurality of connecting flow paths 34 from the inflow-side flow path 301. As a result, when one of the plurality of connecting flow paths 34 is to be connected to the outflow-side flow path 302, the communication of the inflow-side flow path 301 is blocked, thereby effectively preventing the collection target M from moving toward the inflow tube 16.
[0096] As shown in Figures 5 and 7, the collection method for collecting collection objects M into multiple sampling containers 14 via the collection kit 10 includes a collection step in which the collection objects M are introduced into multiple storage chambers 28, respectively, and a separation step in which the medical bag 12 is separated from the inlet tube 16. Thereafter, the multiple sampling containers 14 are sequentially connected to the outlet port 36, and the multiple connecting flow paths 34 are selectively closed and opened, thereby sequentially transferring the collection objects M from the multiple storage chambers 28 to the multiple sampling containers 14.
[0097] This collection method improves work efficiency when collecting collection targets M into multiple sampling containers 14. Furthermore, since multiple storage chambers 28 can each store a collection target M, it is possible to collect a predetermined amount of collection targets M. By providing a single outlet port 36 for sequentially collecting samples into multiple sampling containers 14, the collection kit 10 having multiple storage chambers 28 can be made simple in structure and at low cost.
[0098] 11, the collection kit 10A according to the second embodiment includes a flow path switching unit 22A that selectively connects either the first connection flow path 341 or the second connection flow path 342 in the collection bag 18 to the outlet flow path 302 of the main flow path 30. Note that the same components as those in the collection kit 10 according to the first embodiment shown in FIG. 1 are designated by the same reference numerals, and detailed description thereof will be omitted.
[0099] 12 , the flow path switching unit 22A includes a single housing 58A and multiple blocking units 70. As shown in FIG. 13A , the housing 58A movably holds a blocking member 84. The housing 58A includes a main body 721, a bottom portion 722 provided at the lower part of the main body 721 and constituting the bottom, and a cover portion 723 covering the upper part of the main body 721.
[0100] As shown in FIG. 14 , the main body 721 is formed in a box shape. The main body 721 has a plurality of guide portions 74 inside. Each guide portion 74 has a pair of guide walls 741 extending in the vertical direction of the main body 721. The pair of guide walls 741 face each other and are parallel to each other. Each guide wall 741 has a guide groove 742. The guide grooves 742 extend in the vertical direction. As shown in FIG. 13A , the bottom of the main body 721 has a hole 76 penetrating the bottom.
[0101] The bottom portion 722 covers the bottom of the main body 721. A portion of the collection bag 18 is housed inside the bottom portion 722. As shown in FIG. 14 , the connection portion 44 of the collection bag 18 is housed inside the bottom portion 722. The inlet-side flow path 301, the outlet-side flow path 302, the first connecting flow path 341, and the second connecting flow path 342 of the main flow path 30 are respectively disposed in the recesses 584 in the side wall of the bottom portion 722. The bottom wall of the bottom portion 722 has a plurality of pedestals 585A. The plurality of pedestals 585A are disposed at positions facing the inlet-side flow path 301, the first connecting flow path 341, and the second connecting flow path 342 of the main flow path 30. The plurality of pedestals 585A face the hole portion 76 of the main body 721.
[0102] The cover portion 723 covers the upper part of the main body 721. As shown in Fig. 13A, the cover portion 723 has a plurality of openings 78 and a plurality of support portions 80 provided inside the cover portion 723. The plurality of openings 78 penetrate the cover portion 723. The plurality of support portions 80 are arranged in pairs outward in the width direction of the openings 78. The support portions 80 protrude in a direction perpendicular to the cover portion 723. Each pair of support portions 80 supports a pin member 82 that supports the blocking portion 70, which will be described later.
[0103] The pin member 82 faces the opening 78 and extends in a direction intersecting the opening direction of the opening 78 (see FIG. 15 ). As shown in FIG. 12 , the multiple openings 78 include a first opening 781, a second opening 782, and a third opening 783. The first opening 781 is located on one side of the width direction of the cover portion 723 and faces the first connection flow path 341 of the collection bag 18. The second opening 782 is parallel to the first opening 781 and located on the other side of the width direction of the cover portion 723. The second opening 782 faces the second connection flow path 342 of the collection bag 18. The third opening 783 is located between the first opening 781 and the second opening 782 and faces the inlet-side flow path 301.
[0104] The multiple blockers 70 are capable of blocking the first connection flow path 341 and the second connection flow path 342, respectively. The multiple blockers 70 include a first blocker 701 capable of blocking the first connection flow path 341 and a second blocker 702 capable of blocking the second connection flow path 342. The first blocker 701 is disposed in a first opening 781 of the cover portion 723. The second blocker 702 is disposed in a second opening 782 of the cover portion 723. The blocker 70 further includes a third blocker 703 capable of blocking the inlet flow path 301 of the main flow path 30. The third blocker 703 is disposed in a third opening 783 of the cover portion 723.
[0105] In this embodiment, the first blocking unit 701, the second blocking unit 702, and the third blocking unit 703 have the same configuration, and therefore the following will describe in detail the third blocking unit 703. The first blocking unit 701 and the second blocking unit 702 are the same as the third blocking unit 703 except that they are attached to the first opening 781 and the second opening 782.
[0106] As shown in FIG. 13A , the third blocking unit 703 includes a blocking member 84 and a pressing member 86. The blocking member 84 is provided so as to be movable in the thickness direction of the collection bag 18. As shown in FIG. 15 , the blocking member 84 is disposed between a pair of guide walls 741 of the main body 721. As the blocking member 84 moves, the blocking member 84 is guided in the thickness direction of the collection bag 18 by the pair of guide portions 74. The base end of the blocking member 84 is disposed on the cover portion 723 side and includes a pressed portion 841. The pressed portion 841 has a surface perpendicular to the axial direction of the blocking member 84. The base end of the blocking member 84 has a protrusion 842 protruding laterally from the pressed portion 841, and the protrusion 842 is inserted into the guide groove 742 of the guide wall 741.
[0107] 13A , the tip of the blocking member 84 has a blocking portion 843. The blocking portion 843 is tapered toward the tip. The blocking portion 843 is inserted into the hole 76 of the main body 721. When the blocking member 84 moves toward the collection bag 18, the blocking portion 843 presses against and blocks the inlet-side flow path 301 of the main flow path 30.
[0108] A resilient member 88 is provided on the outer periphery of the blocking member 84. The resilient member 88 is, for example, a coil spring. The resilient member 88 is provided between the protrusion 842 of the blocking member 84 and the bottom of the main body 721. The resilient member 88 has a resilient force that biases the blocking member 84 in a direction away from the collection bag 18.
[0109] The pressing member 86 is provided on the housing 58A. The pressing member 86 faces the pressed portion 841 of the blocking member 84. The pressing member 86 includes a cam portion 861 and an operating portion 862. The cam portion 861 has a pin hole 90 through which the pin member 82 is inserted. The cam portion 861 has a first pressing portion 921 having an outer peripheral surface of a constant diameter centered on the pin hole 90, and a second pressing portion 922 having a larger radius centered on the pin hole 90 than the outer peripheral surface of the first pressing portion 921. The second pressing portion 922 has an apex 94 that is furthest from the pin hole 90. The outer peripheral surface of the cam portion 861 abuts against the pressed portion 841 of the blocking member 84. The pin member 82 inserted through the support portion 80 of the cover portion 723 is inserted into the pin hole 90 of the cam portion 861. The pin member 82 rotatably supports a pressing member 86 including a cam portion 861 .
[0110] The operating portion 862 is exposed to the outside of the housing 58A through the opening 78. The user grips the operating portion 862 when switching the open / close state of the inlet-side flow path 301 with the third blocking portion 703. The operating portion 862 protrudes radially outward from the outer circumferential surface of the first pressing portion 921. The operating portion 862 is disposed on the opposite side of the pin hole 90 from the apex 94 of the second pressing portion 922.
[0111] The operating portion 862 is inserted through the opening 78 and exposed to the outside of the cover portion 723. The pressing member 86 is supported by a pair of support portions 80 so as to be rotatable.
[0112] 13A , when the first pressing portion 921 of the cam portion 861 is in contact with the pressed portion 841 of the blocking member 84, the blocking member 84 is not pressed toward the collection bag 18, and the blocking portion 843 of the blocking member 84 is in an open position separated from the inlet-side flow path 301. At this time, the operating portion 862 is positioned to protrude upward.
[0113] When the user operates the operating portion 862 of the pressing member 86, the pressing member 86 presses the blocking member 84 toward the inlet-side flow path 301. As shown in FIG. 17 , when the operating portion 862 is operated downward to rotate the pressing member 86, and the second pressing portion 922 of the cam portion 861 contacts the pressed portion 841 of the blocking member 84, the apex 94 of the cam portion 861 presses the blocking member 84 toward the collection bag 18. Because the radius of the second pressing portion 922 relative to the pin hole 90 is larger than the radius of the first pressing portion 921 relative to the pin hole 90, the second pressing portion 922 moves the blocking member 84 toward the collection bag 18 while compressing the resilient member 88. The blocking portion 843 of the blocking member 84 presses the inlet-side flow path 301 toward the base 585A, blocking the inlet-side flow path 301. At this time, the operating portion 862 is positioned to protrude downward.
[0114] The blocking member 84 of the first blocking unit 701 is provided so as to be movable toward the first connection flow path 341. The pressing member 86 of the first blocking unit 701 is provided so as to be exposed to the outside from the first opening 781. When the user operates the operating portion 862 of the pressing member 86 of the first blocking unit 701 downward, the pressing member 86 presses the blocking member 84 toward the first connection flow path 341.
[0115] 13B , the blocking member 84 of the second blocking unit 702 is provided to be movable toward the second connection flow path 342. The pressing member 86 of the second blocking unit 702 is provided to be exposed to the outside through the second opening 782. When a user operates the operating portion 862 of the pressing member 86 of the second blocking unit 702 downward, the pressing member 86 presses the blocking member 84 toward the second connection flow path 342. The blocking members 84 of the first blocking unit 701 and the second blocking unit 702 can selectively press the first connection flow path 341 and the second connection flow path 342. The blocking member 84 of the third blocking unit 703 is provided to be movable toward the inlet-side flow path 301 of the main flow path 30. The third blocking unit 703 can selectively press the inlet-side flow path 301 of the main flow path 30.
[0116] Note that the present invention is not limited to the case where multiple shutoff units 70 are provided in a single housing 58A. For example, multiple housings may be provided to hold the multiple shutoff units 70 (first shutoff unit 701, second shutoff unit 702, third shutoff unit 703), and each housing may be attached to the first connecting flow path 341, the second connecting flow path 342, and the inlet-side flow path 301.
[0117] Next, the operation of the flow path switching unit 22A when the sampling target M is divided into the first sampling container 141 and the second sampling container 142 using the sampling kit 10A according to the second embodiment will be described.
[0118] First, in the connecting step of connecting the medical bag 12 to the inflow tube 16, as shown in Fig. 12 , the flow path switching unit 22A is set to an open position in which the operating portions 862 of the pressing members 86 of the first blocking unit 701, second blocking unit 702, and third blocking unit 703 are positioned so as to face upward of the collection bag 18. The state in which the first blocking unit 701, second blocking unit 702, and third blocking unit 703 shown in Fig. 12 are all in the open position will be described as the initial position. In the initial position, the first connecting flow path 341, the second connecting flow path 342, and the inflow-side flow path 301 are in communication with each other via the connecting portion 44.
[0119] After the sample M is introduced from the medical bag 12 into the first storage chamber 281 and the second storage chamber 282 through the inlet tube 16, the inlet side flow path 301, the first connecting flow path 341 and the second connecting flow path 342, respectively, a process is performed in which the sample M in the first storage chamber 281 is transferred to the first sampling container 141.
[0120] As shown in FIG. 16 , the inflow-side flow path 301 is blocked by the third blocking unit 703 of the flow path switching unit 22A. The user operates the operating unit 862 of the third blocking unit 703, and as shown in FIG. 17 , rotates the pressing member 86 so that the operating unit 862 faces downward to the blocking position. The rotation of the pressing member 86 causes the second pressing portion 922 to face the pressed portion 841 of the blocking member 84, and the second pressing portion 922 presses the blocking member 84 toward the collection bag 18. The blocking member 84 moves toward the inflow-side flow path 301 while compressing the resilient member 88, and the blocking portion 843 of the blocking member 84 presses the inflow-side flow path 301 against the base 585A. The inflow-side flow path 301 is blocked by the blocking member 84. The pressing member 86 of the third blocking unit 703 is maintained in a state in which it presses the blocking member 84.
[0121] As shown in FIG. 18 , the second connection flow path 342 is blocked by the second blocking unit 702 of the flow path switching unit 22A. The user operates the operating unit 862 of the second blocking unit 702 so that it faces downward, and as shown in FIG. 19 , the pressing member 86 is rotated to the blocking position by operating the operating unit 862. The rotation of the pressing member 86 causes the second pressing portion 922 to face the pressed portion 841 of the blocking member 84, and the second pressing portion 922 presses the blocking member 84 toward the collection bag 18. The blocking member 84 moves toward the second connection flow path 342 while compressing the resilient member 88, and the blocking portion 843 of the blocking member 84 presses the second connection flow path 342 against the base 585A. The second connection flow path 342 is blocked by the blocking member 84. The pressing member 86 of the second blocking unit 702 is maintained in a state in which it presses the blocking member 84.
[0122] By connecting the first sampling container 141 to the adapter 20, the sample M in the first storage chamber 281 is transferred to the first sampling container 141 through the first connection flow path 341, the outlet side flow path 302, and the outlet port 36.
[0123] Next, after the first sampling container 141 is removed from the adapter 20, a step of transferring the collection target M in the second storage chamber 282 to the second sampling container 142 is carried out.
[0124] After connecting the second sampling container 142 to the adapter 20, the first connection flow path 341 is blocked by the first blocking unit 701 of the flow path switching unit 22A, as shown in FIG. 20 . The user operates the operating unit 862 of the first blocking unit 701 to rotate the pressing member 86 so that the operating unit 862 faces downward to the blocking position. The rotation of the pressing member 86 moves the blocking member 84 toward the first connection flow path 341, and the first connection flow path 341 is blocked by the blocking unit 843 of the blocking member 84. The pressing member 86 of the first blocking unit 701 is held in a state in which it presses the blocking member 84.
[0125] The second connection flow path 342 is opened by the second blocking unit 702 of the flow path switching unit 22A. The user operates the operating unit 862 of the second blocking unit 702 to rotate the pressing member 86 so that the operating unit 862 faces upward to the open position. The rotation of the pressing member 86 causes the first pressing portion 921 to face the pressed portion 841 of the blocking member 84, thereby reducing the pressing force of the pressing member 86 on the blocking member 84. As shown in FIG. 13B , the elastic force of the elastic member 88 moves the blocking member 84 in a direction away from the collection bag 18. The closing portion 843 of the blocking member 84 moves away from the second connection flow path 342, and the second connection flow path 342 elastically returns to its original shape. The second connection flow path 342 is unblocked, and the second storage chamber 282 and the outlet-side flow path 302 are connected through the second connection flow path 342.
[0126] The collection target M in the second storage chamber 282 is transferred to the second sampling container 142 through the second connecting flow path 342 , the outlet side flow path 302 , and the outlet port 36 .
[0127] In addition, when transferring the object to be collected M from the first storage chamber 281 and the second storage chamber 282 to the first sampling container 141 and the second sampling container 142, the blocking member 84 of the third blocking section 703 is pushed toward the inlet side flow path 301 to block the inlet side flow path 301, as described above, but the object to be collected M may also be transferred with the inlet side flow path 301 open.
[0128] 12 , the flow path switching unit 22A includes a plurality of blocking units 70 (first blocking unit 701, second blocking unit 702) that can respectively block a plurality of connection flow paths 34 (first connection flow path 341, second connection flow path 342). The plurality of blocking units 70 have a plurality of blocking members 84 that can move toward the plurality of connection flow paths 34, and the plurality of blocking members 84 can selectively press the plurality of connection flow paths 34.
[0129] As a result, by moving each of the blocking members 84 of the multiple blocking sections 70, the multiple connection flow paths 34 can be selectively pressed and blocked.
[0130] The flow path switching unit 22A has a single housing 58A that movably holds a plurality of blocking members 84, and the plurality of blocking units 70 each have a plurality of operating units 862 that are provided on the housing 58A and exposed from the housing 58A. As shown in Fig. 14, the flow path switching unit 22A includes a plurality of pressing members 86 that a user operates to push the blocking members 84 toward each of the plurality of connection flow paths 34.
[0131] As a result, by operating each of the multiple operating parts 862, the pressing member 86 can effectively move the blocking member 84 toward each of the multiple connection flow paths 34. By providing multiple blocking parts 70 in a single housing 58A, the flow path switching unit 22A can be configured compactly.
[0132] 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 multiple sampling containers, comprising: an inflow tube to which the medical bag is connected; and a collection bag connected downstream of the inflow tube and formed by welding two flexible sheets together, wherein the collection bag has: a plurality of storage chambers for storing the samples; a single outlet port for transferring the samples from the plurality of storage chambers to the plurality of sampling containers, respectively; at least one exhaust section for exhausting air from the interior of the plurality of storage chambers; a single main flow path connecting the inflow tube and the outlet port; and a plurality of connecting flow paths provided between the main flow path and the plurality of storage chambers, connecting each of the storage chambers to the main flow path.
2. A collection kit according to claim 1, wherein the collection bag has a connection part connecting the plurality of connection flow paths to the main flow path, the main flow path having an inlet side flow path connecting the connection part to the inlet tube, and an outlet side flow path connecting the connection part to the outlet port, and the collection kit is provided with a flow path switching part that selectively connects any one of the plurality of connection flow paths to the outlet side flow path.
3. A collection kit according to claim 2, wherein the collection bag has a cutout portion formed by cutting out a part of the flexible sheet in the thickness direction of the collection bag so as to surround the connection portion, and the flow path switching portion is provided in the cutout portion.
4. A collection kit according to claim 2 or 3, wherein the flow path switching unit comprises a switching member that is rotatable relative to the collection bag, the switching member having a blocking part that selectively blocks one of the plurality of connection flow paths, and by selecting the rotational position of the switching member, one of the plurality of connection flow paths can be blocked by the blocking part.
5. A collection kit as described in claim 4, wherein the flow path switching unit has a housing that rotatably holds the switching member, the switching member is arranged to be movable in the thickness direction of the collection bag relative to the housing, and the switching member moves in the thickness direction toward the connecting flow path, causing the blocking unit to press the connecting flow path toward the housing.
6. A collection kit as described in claim 4, wherein the blocking portion of the switching member is capable of blocking the inlet-side flow path, and by selecting the rotational position of the switching member, one of the plurality of connecting flow paths and the inlet-side flow path can be blocked by the blocking portion.
7. A collection kit according to claim 2 or 3, wherein the flow path switching unit is provided with a plurality of blocking units capable of blocking each of the plurality of connecting flow paths, and the plurality of blocking units have a plurality of blocking members that are respectively movable toward the plurality of connecting flow paths, and the plurality of connecting flow paths can be selectively pressed by the plurality of blocking members.
8. A collection kit as described in claim 7, wherein the flow path switching unit has a single housing that movably holds the multiple blocking members, and the multiple blocking members each have multiple operating units that are provided on the housing and exposed from the housing, and are equipped with multiple pressing members that press the blocking members toward each of the multiple connecting flow paths by operating the operating units.
9. A collection method for collecting collection objects contained in a medical bag into multiple sampling containers via a collection kit, the collection kit comprising: an inlet tube to which the medical bag is connected; and a collection bag connected downstream of the inlet tube and formed by welding two flexible sheets together; the collection bag comprising: a plurality of storage chambers for storing the collection objects; a single outlet port for transferring the collection objects from the plurality of storage chambers to the plurality of sampling containers, respectively; at least one exhaust section for exhausting air from the interiors of the plurality of storage chambers; a single main flow path connecting the inlet tube to the outlet port; a plurality of connecting flow paths provided between the main flow path and the plurality of storage chambers and connecting each of the storage chambers to the main flow path; connecting sections connecting the plurality of connecting flow paths to the main flow path; an inlet-side flow path provided in the main flow path and connecting the connecting section to the inlet tube; and an outlet-side flow path provided in the main flow path and connecting the connecting section to the outlet port; the collection method comprising: a connecting step of connecting the medical bag to the inflow tube; an introducing step of introducing the sample to be collected, which has moved from the medical bag to the inside of the collection bag through the inflow tube and the inflow-side flow path, into each of the plurality of storage chambers through the plurality of connecting flow paths; a separating step of separating the medical bag from the inflow tube after introducing the sample to each of the plurality of storage chambers; and a collecting step of sequentially connecting the plurality of sampling containers to the outflow port and selectively closing and opening the plurality of connecting flow paths, thereby sequentially transferring the sample to be collected from the plurality of storage chambers to the plurality of sampling containers.
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