Collection kit

Abstract

SOLUTION: A collection kit 10 comprises: a tube for connection 12 that is connectable with a platelet bag; a syringe 14 that stores a predetermined amount of liquid sample; and a holder for sampling 16 that is connectable with culture bottles. The syringe 14 has a barrel body 22, a gasket 24 that slides inside the barrel body 22, and a plunger 26 that is attached to the gasket 24. The barrel body 22 has a capacity that allows storage of the liquid sample in an amount collected in the two culture bottles. The syringe 14 has a stopper structure 28 that is in contact with the plunger 26 at a predetermined position and inhibits a movement of the plunger 26 in an axial direction against a negative pressure of the culture bottles.EFFECT: A collection kit allows even a less experienced operator to collect a precise amount of liquid sample into a culture bottle. Separating the liquid sample and air from each other by a gasket can prevent mixing of the air into the culture bottle used for anaerobic culture.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] The present invention relates to a collection kit for collecting blood products for testing. [Background technology]

[0002] To ensure the safety of blood products, a small amount of liquid sample is taken and cultured before shipping. For culture testing, a specified amount of liquid sample (blood product) is taken in a culture bottle, which is then stored for a specified period at a temperature of 30-40°C, which is suitable for bacterial growth, and the growth of bacteria in the culture bottle is then confirmed.

[0003] A dedicated collection kit is used to collect a liquid sample into a culture bottle. For example, Patent Document 1 discloses a collection kit for collecting a liquid sample from a blood bag. This collection kit collects a predetermined amount of liquid sample in a sample collection tube. Next, the liquid sample is transferred to the culture bottle while checking the transferred amount using the markings on the sample collection tube. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] U.S. Patent No. 8,777,921 Summary of the Invention [Problem to be solved by the invention]

[0005] With conventional collection kits, the liquid level in the collection bottle changes rapidly due to suction caused by the negative pressure of the culture bottle. This makes it difficult for inexperienced operators to measure and collect a consistent amount of liquid sample into the culture bottle, which can result in over or under-volume collection of the liquid sample. Furthermore, with conventional collection kits, there is a risk that users may accidentally mix air into the liquid sample when transferring it to the anaerobic culture bottle.

[0006] An object of the present invention is to solve the above-mentioned problems. [Means for solving the problem]

[0007] One aspect of the following disclosure is a collection kit comprising: a connection tube to which a medical bag containing a liquid sample can be connected; a syringe connected to the connection tube and containing a predetermined amount of the liquid sample; and a sampling holder connected to the syringe and to which a culture bottle can be connected, wherein the syringe has a barrel body, a gasket that slides inside the barrel body, and a plunger attached to the gasket, the barrel body has a volume capable of containing the amount of liquid sample to be collected in two of the culture bottles, and the syringe has a stopper structure that abuts against the plunger and prevents the plunger from moving axially against the negative pressure of the culture bottle. [Effects of the Invention]

[0008] The collection kit of the above aspect allows the transfer of a liquid sample to a culture bottle to be controlled by operating a syringe. Therefore, the collection kit allows even inexperienced operators to collect an accurate amount of liquid sample into a culture bottle. Furthermore, a gasket separates the liquid sample from the air inside the barrel body, preventing air from entering the culture bottle used for anaerobic culture. [Brief explanation of the drawings]

[0009] [Figure 1] FIG. 1 is a plan view of a collection kit according to a first embodiment. [Figure 2] FIG. 2 is a cross-sectional view of the collection kit of FIG. [Figure 3] 3A is a perspective view of a plunger assembly of the syringe of FIG. 1, and FIG. 3B is a perspective cross-sectional view of a barrel body of the syringe of FIG. [Figure 4] 4A is a plan view showing a step of connecting a platelet bag to the collection kit of FIG. 1, and FIG. 4B is a cross-sectional view showing a step of collecting a liquid sample (platelet preparation) in the syringe of FIG. 4A. [Figure 5]Figure 5A is an explanatory diagram showing the process of connecting the first culture bottle to the collection kit of Figure 4B, and Figure 5B is a cross-sectional view showing the operation of the syringe when transferring a liquid sample to the first culture bottle. [Figure 6] Figure 6A is an explanatory diagram showing the process of removing the first culture bottle from the collection kit of Figure 5A and connecting the second culture bottle, and Figure 6B is a cross-sectional view showing the operation of the syringe when transferring a liquid sample to the second culture bottle. [Figure 7] FIG. 7A is a plan view of a syringe according to a modified example of the first embodiment, and FIG. 7B is a perspective cross-sectional view of a barrel body of the syringe of FIG. 7A. [Figure 8] FIG. 8A is a perspective view of a gasket and a plunger of a syringe according to a second embodiment, and FIG. 8B is a perspective cross-sectional view of a barrel body of the syringe according to the second embodiment. [Figure 9] FIG. 9A is a cross-sectional view of a syringe according to a third embodiment, and FIG. 9B is a diagram illustrating the operation of the syringe of FIG. 9A. [Figure 10] FIG. 10 is an explanatory diagram showing a modified example of the syringe of FIG. DETAILED DESCRIPTION OF THE INVENTION

[0010] (First embodiment) The collection kit 10 according to this embodiment shown in FIG. 1 is used, for example, in culture tests to confirm the safety of blood products at a business facility such as a blood center that produces blood products. The culture tests involve culturing anaerobic bacteria and aerobic bacteria. Therefore, two culture bottles 90 (see FIG. 6A), one for aerobic culture and one for anaerobic culture, are used in the culture tests. The collection kit 10 is used to collect a liquid sample, such as a platelet product, and to collect predetermined amounts (e.g., 8 ml or 10 ml) of the liquid sample into an aerobic culture bottle 92 and an anaerobic culture bottle 94.

[0011] As shown in FIG. 1, the collection kit 10 includes a connecting tube 12, a syringe 14, a sampling holder 16, a three-way stopcock 18, and a second tube 20. The connecting tube 12 and the second tube 20 are translucent medical tubes made of a thermoplastic resin such as polyvinyl chloride resin. By using a sterile joining device, the connecting tube 12 can be connected to other medical tubes without exposing the interior to the outside air. Furthermore, by using a tube sealer, the connecting tube 12 can be separated from other medical tubes and the ends sealed without exposing the interior to the outside air.

[0012] The connecting tube 12 has a first end 12a on the upstream side and a second end 12b on the downstream side. The first end 12a is welded and sealed in the initial state (the state when the product is first provided). The second end 12b is connected to a first port 18a of a three-way stopcock 18.

[0013] The three-way stopcock 18 connects the connecting tube 12, the syringe 14, and the sampling holder 16. The three-way stopcock 18 has a first port 18a, a second port 18b, a third port 18c, and a flow path switching cock 18d. The connecting tube 12 is connected to the first port 18a. The sampling holder 16 is connected to the second port 18b. The syringe 14 is connected to the third port 18c via a second tube 20.

[0014] The flow path switching cock 18d has a T-shaped flow path 18e shown in Fig. 2. In a first position, which is an initial state, the flow path switching cock 18d fluidly connects the connecting tube 12 and the second tube 20 (and the syringe 14) as shown in the figure. In the first position, the flow path switching cock 18d blocks fluid communication between the sampling holder 16 and the connecting tube 12 and the syringe 14.

[0015] The flow path switching cock 18d fluidly connects the sampling holder 16, the connection tube 12, and the syringe 14 at a second position rotated 180 degrees from the first position.

[0016] The second tube 20 connects the three-way stopcock 18 and the syringe 14. One end of the second tube 20 is connected to the third port 18c of the three-way stopcock 18, and the other end is connected to the nozzle 34 of the syringe 14. The second tube 20 is a medical tube that has the same flexibility as the connecting tube 12. The second tube 20 serves both as a path for introducing the liquid sample from the platelet bag 100 into the syringe 14 and as a path for transferring the liquid sample from the syringe 14 to the culture bottle 90.

[0017] The syringe 14 includes a barrel body 22, a gasket 24, and a plunger 26. The barrel body 22 includes a cylindrical main body portion 30, and the gasket 24 and the plunger 26 are housed in a housing space 36 of the main body portion 30.

[0018] As shown in Fig. 3A, the gasket 24 and the plunger 26 are assembled together to form a plunger assembly 27. As shown in Fig. 2, the base end of the plunger 26 protrudes toward the base end of the barrel body 22. The plunger 26 is displaced integrally with the gasket 24. The plunger 26 transmits the operating force of the user to the gasket 24.

[0019] The plunger 26 has a first concave-convex structure 25, a flange 26b, and a gasket mounting portion 26c. The first concave-convex structure 25 is, for example, a pair of protrusions 26a. The protrusions 26a are rod-shaped members that protrude radially outward from the central axis of the plunger 26. The pair of protrusions 26a are located approximately midway between the flange 26b located at the base end and the gasket mounting portion 26c located at the tip end. The pair of protrusions 26a are arranged 180° apart in the circumferential direction. The number of protrusions 26a is not limited to two, and may be one or three or more.

[0020] The protrusion 26a is formed integrally with the plunger 26. The dimension from the central axis of the plunger 26 to the tip (radially outer end) of the protrusion 26a is set to a value slightly smaller than half the inner diameter dimension of the barrel body 22. Therefore, inside the barrel body 22, the protrusion 26a is located near the inner circumferential surface 40 of the barrel body 22.

[0021] The gasket 24 has an outer diameter that allows it to be inserted into the housing space 36 of the barrel body 22. The outer peripheral surface 24a of the gasket 24 is a smooth cylindrical surface, and it can slide axially while making liquid-tight contact with the inner peripheral surface 40 of the barrel body 22. The gasket 24 is attached to the plunger 26 by a gasket attachment portion 26c. The gasket 24 moves integrally with the plunger 26.

[0022] The barrel body 22 has a cylindrical body portion 30, a neck portion 32 formed at the tip of the body portion 30, and a nozzle 34 protruding from the tip of the neck portion 32 toward the tip. As shown in FIG. 2 , the body portion 30 has a cylindrical storage space 36 inside. The storage space 36 opens at the base end. A gasket 24 is stored in the storage space 36. The gasket 24 is inserted through the opening at the base end of the storage space 36. The tip side of the storage space 36 is covered by the neck portion 32. The storage space 36 between the gasket 24 and the neck portion 32 forms a storage section 38 that is liquid-tightly sealed by the gasket 24. The storage section 38 stores a liquid sample. In the initial state, the gasket 24 abuts against the neck portion 32, and the volume of the storage section 38 is zero.

[0023] The inner circumferential surface 40 of the main body 30 surrounds the storage space 36. The inner circumferential surface 40 has a smooth cylindrical surface. The inner circumferential surface 40 allows the gasket 24 to slide smoothly while maintaining liquid-tight and airtight properties. The barrel body 22 has a second concave-convex structure 23. The second concave-convex structure 23 is, for example, a guide rail 42 protruding from the inner circumferential surface 40. The guide rail 42 has a pair of linear protrusions 44 and a guide groove 46. The pair of linear protrusions 44 have a crank shape and are arranged with a certain width between them. The guide groove 46 is formed between the pair of linear protrusions 44. The guide groove 46 has a width sufficient to accommodate the protrusion 26a of the plunger 26. The guide groove 46 slidably accommodates the protrusion 26a, thereby restricting the direction in which the plunger 26 can move.

[0024] The guide groove 46 has a crank shape and includes a first shaft groove 46a and a second shaft groove 46b extending in the axial direction and a circumferential groove 46c extending in the circumferential direction perpendicular to the axial direction. The first shaft groove 46a and the second shaft groove 46b are connected via the circumferential groove 46c. The first shaft groove 46a and the second shaft groove 46b are arranged at different angles in the circumferential direction. Therefore, when the plunger 26 moves significantly in the axial direction, the protrusion 26a of the plunger 26 enters the circumferential groove 46c. The protrusion 26a of the plunger 26 abuts against the linear protrusion 44 adjacent to the circumferential groove 46c, thereby restricting the axial movement of the plunger 26. The guide rail 42 and the protrusion 26a form a stopper structure 28 that restricts the axial movement of the plunger 26.

[0025] When the plunger 26 is rotated in the circumferential direction, the protrusion 26a of the plunger 26 moves along the circumferential groove 46c. When the protrusion 26a moves from the first axial groove 46a to the second axial groove 46b (or vice versa), the restriction on the axial movement of the plunger 26 by the stopper structure 28 is released.

[0026] The circumferential groove 46c stops the plunger 26 at an intermediate stop position in the axial direction. The intermediate stop position is a stop position of the plunger 26 corresponding to a position where the amount of liquid sample contained in the syringe 14 is enough to fill one culture bottle 90. When the plunger 26 stops at the intermediate stop position, the volume of the storage section 38 is, for example, 8 ml or 10 ml, which is equal to the amount of liquid sample to be collected in one culture bottle 90.

[0027] The barrel body 22 is provided with the guide rails 42, the number of which corresponds to the number of protrusions 26a of the plunger 26. In the illustrated example, two guide rails 42 are arranged circumferentially at an angle of 180°.

[0028] The barrel body 22 is made of a transparent resin material, allowing the liquid sample and air bubbles contained therein to be visually observed. Marked lines 35 are arranged on the outer periphery of the barrel body 22 at positions corresponding to the first and second stop positions (see FIG. 1).

[0029] As shown in FIG. 10 , the syringe 14 may further include a sealing member 49 connecting the base end of the barrel body 22 and the plunger 26. The sealing member 49 is a tubular member formed of a flexible resin sheet or the like. One end of the sealing member 49 is connected to the base end of the barrel body 22, and the other end is connected to the base end of the plunger 26. The sealing member 49 is bellows-shaped. The sealing member 49 deforms from a folded bellows-like shape to an elongated tubular shape depending on the position of the plunger 26. That is, the sealing member 49 follows the displacement of the plunger 26 as the bellows expand. The sealing member 49 seals the gap between the plunger 26 and the barrel body 22 from the outside air, thereby maintaining the sterility of the containing space 36. The sealing member 49 prevents bacterial adhesion to the inner wall of the barrel body 22, thereby preventing false positives in tests in which a formulation is deemed contaminated despite being sterile.

[0030] As shown in FIG. 2, the sampling holder 16 has a needle tube 50, a needle hub 52, and a cap 54. The needle tube 50 is punctured into and penetrates a stopper 96 of a culture bottle 90, which will be described later. The needle tube 50 has an internal lumen 50a. When the needle tube 50 penetrates the stopper 96, the lumen 50a communicates with the internal space of the culture bottle 90. The needle hub 52 supports the base of the needle tube 50. The needle hub 52 has a flow path 52a that communicates with the lumen 50a. The needle hub 52 also has a cylindrical portion 52b that holds the inlet of the culture bottle 90.

[0031] The sampling holder 16 has a cap 54 to prevent bacterial adhesion to the needle tube 50. In the initial state, the cap 54 covers and closes the cylindrical portion 52b. The needle tube 50 is sealed by the cylindrical portion 52b of the needle hub 52 and the cap 54. The cap 54 is releasably connected to the needle hub 52 by a hinge portion 56. When the cap 54 is opened, the needle tube 50 is exposed. An internal flow path 52a of the needle hub 52 communicates with the second port 18b of the three-way stopcock 18.

[0032] The collection kit 10 of this embodiment is configured as described above. This collection kit 10 is used as follows.

[0033] 4A, first, a step is performed in which a platelet bag 100 (medical bag) containing a platelet preparation is connected to the connecting tube 12 of the collection kit 10. This step is performed by joining the tube 102 extending from the platelet bag 100 to the connecting tube 12 using a sterile joining device.

[0034] 4B, a step of placing a liquid sample (a part of the platelet preparation) in the syringe 14 is performed. Prior to this step, a step of replacing the air inside the connecting tube 12 and the second tube 20 with the liquid sample is performed. This step is performed by, for example, compressing the connecting tube 12 and the second tube 20 with the platelet bag 100 placed above.

[0035] Thereafter, plunger 26 of syringe 14 is retracted toward the base end, thereby storing the liquid sample in storage portion 38 of syringe 14. During this operation, plunger 26 may be moved back and forth in small increments in the axial direction to remove air bubbles from inside syringe 14. When plunger 26 reaches the second stop position, the axial movement of plunger 26 is prevented by stopper structure 28. By rotating plunger 26 circumferentially by a predetermined angle, the prevention of axial movement of plunger 26 by stopper structure 28 is released.

[0036] Furthermore, as plunger 26 is retracted, the amount of liquid sample contained in storage portion 38 increases. The retraction operation of plunger 26 is stopped at a position (first stop position) where the tip of gasket 24 coincides with marked line 35 on the base end side. By performing the operations up to this point, the syringe 14 contains the amount of liquid sample necessary to collect in two culture bottles 90.

[0037] Thereafter, a step is performed in which the platelet bag 100 is separated from the collection kit 10. This step is performed by cutting and separating the tube 102 of the platelet bag 100 and the connecting tube 12 while welding the cut portions using a tube sealer.

[0038] Next, as shown in FIG. 5A, a step of placing a liquid sample in a first culture bottle 90 is performed. In this step, the first culture bottle 90 is connected to the sampling holder 16 of the collection kit 10. The first culture bottle 90 is an aerobic culture bottle 92. Then, the flow path switching cock 18d is rotated to the second position. With the flow path switching cock 18d in the second position, the sampling holder 16, the second tube 20, and the connection tube 12 communicate with each other.

[0039] Because the aerobic culture bottle 92 has a negative pressure inside, it sucks in the liquid sample from the syringe 14. The negative pressure causes the plunger assembly 27 to displace axially toward the tip. The protrusion 26a of the plunger 26 moves along the first axial groove 46a of the guide rail 42. As shown in FIG. 5B , when the plunger 26 reaches the intermediate stop position, the protrusion 26a enters the circumferential groove 46c and abuts against the linear protrusion 44. As a result, the stopper structure 28 restricts the axial movement of the plunger 26. The transfer of the liquid sample to the aerobic culture bottle 92 stops.

[0040] At this point, a predetermined amount (e.g., 8 ml or 10 ml) of liquid sample is collected in the aerobic culture bottle 92. In the collection kit 10 of this embodiment, the plunger 26 reliably stops at the intermediate stop position, so even if an inexperienced operator operates the kit, an accurate amount of liquid sample can be collected in the aerobic culture bottle 92.

[0041] As the liquid sample is transferred to the aerobic culture bottle 92, air in the lumen 50a of the needle tube 50 and the flow path 52a of the needle hub 52 is discharged into the aerobic culture bottle 92. In other words, the transfer of the liquid sample to the aerobic culture bottle 92 also serves as a priming step in which the lumen 50a and the flow path 52a are replaced with the liquid sample. This step prevents air from being mixed into the anaerobic culture bottle 94 later.

[0042] Thereafter, as shown in FIG. 6A, the aerobic culture bottle 92 is removed from the collection kit 10. Next, a step of collecting a liquid sample in a second culture bottle 90 is performed. The second culture bottle 90 is an anaerobic culture bottle 94. Then, an operation is performed to rotate the plunger 26 in the circumferential direction by a predetermined angle. This operation causes the protrusion 26a (see FIG. 3A) of the plunger 26 to move circumferentially along the circumferential groove 46c (see FIG. 3B) and into the second axial groove 46b. This operation releases the stopper structure 28 from preventing the plunger 26 from moving in the axial direction. Note that the operation of rotating the plunger 26 may be performed after the aerobic culture bottle 92 is removed from the collection kit 10 and before the anaerobic culture bottle 94 is connected.

[0043] The negative pressure inside the anaerobic culture bottle 94 causes the liquid sample in the storage portion 38 of the syringe 14 to be sucked into the anaerobic culture bottle 94. The plunger 26 of the syringe 14 is displaced axially toward the tip. The transfer of the liquid sample into the anaerobic culture bottle 94 continues until the gasket 24 abuts against the neck 32, as shown in FIG. 6B. When the gasket 24 abuts against the neck 32, the transfer of the liquid sample is complete.

[0044] This step completes the collection of a predetermined amount (e.g., 8 ml or 10 ml) of liquid sample into the anaerobic culture bottle 94. In the collection kit 10 of this embodiment, the liquid sample is isolated from air by the gasket 24. Therefore, even when negative pressure is applied to the anaerobic culture bottle 94, the syringe 14 can prevent air from entering the anaerobic culture bottle 94.

[0045] Thereafter, a step is performed in which the anaerobic culture bottle 94 is removed from the collection kit 10. Through the above steps, collection of liquid samples into the aerobic culture bottle 92 and the anaerobic culture bottle 94 is completed.

[0046] (Modification of the first embodiment) The collection kit 10 of the first embodiment is not limited to the above example. As shown in FIG. 7A, the collection kit 10 of this modification includes a connecting tube 12, a syringe 14, a sampling holder 16, a three-way stopcock 18, and an air vent 19. The air vent 19 is attached to the end of the connecting tube 12. The air vent 19 includes a filter that allows air to pass through but prevents liquid from passing through. The air vent 19 allows air to be discharged from inside the flow path of the collection kit 10.

[0047] Furthermore, in this modification, the syringe 14 has a guide groove 46A as the second concave-convex structure 23A. The guide groove 46A is formed penetrating the outer peripheral wall of the barrel body 22. As shown in FIG. 7B , the guide groove 46A has a first axial groove 46a and a second axial groove 46b extending in the axial direction, and a circumferential groove 46c extending in the circumferential direction. The first axial groove 46a is located on the base end side, and the second axial groove 46b is located on the tip end side. The first axial groove 46a and the second axial groove 46b are located at different circumferential positions. The circumferential groove 46c connects the first axial groove 46a and the second axial groove 46b. The circumferential groove 46c constitutes a stopper structure 28 that restricts axial movement of the plunger 26.

[0048] As shown in FIG. 7A, a protrusion 26a protruding radially outward from the side of the plunger 26 is inserted into the guide groove 46A. The tip of the protrusion 26a protrudes outward from the barrel body 22. The protrusion 26a slides within the guide groove 46A. The movement direction of the plunger 26 is restricted by the protrusion 26a and the guide groove 46A. The collection kit 10 of FIG. 7A functions in the same manner as the collection kit 10 of FIG. 1, and the stopper structure 28 of the guide groove 46A allows a predetermined amount of liquid sample to be collected into two culture bottles 90.

[0049] (Second embodiment) Syringe 14A of this embodiment shown in Figures 8A and 8B can be used in place of syringe 14 in Figure 1. In the description of this embodiment, only the main parts of syringe 14A will be described, and detailed description of other configurations will be omitted. In the configuration of syringe 14A, configurations similar to those of syringe 14 in Figure 1 will be assigned the same reference numerals, and detailed description thereof will be omitted.

[0050] As shown in FIG. 8A, the syringe 14A has a plunger 26A. The plunger 26A has a stopper plate 58 at a predetermined position near the center in the axial direction. The stopper plate 58 has a disk shape that extends in a direction perpendicular to the axial direction. The diameter of the stopper plate 58 is smaller than the inner diameter of the barrel body 22A. Therefore, the stopper plate 58 is housed inside the barrel body 22A so as to be movable in the axial direction.

[0051] The stopper plate 58 has a notch 58a in a part of its circumferential direction. The notch 58a extends with a constant width in the radial direction of the stopper plate 58. The width of the notch 58a is greater than the width of the restricting protrusion 60, which will be described later. Therefore, the notch 58a serves as a passage that allows the restricting protrusion 60 to pass through in the axial direction.

[0052] As shown in FIG. 8B , the barrel body 22A has a restricting protrusion 60 at a predetermined position on the main body portion 30. The restricting protrusion 60 is a protrusion that protrudes inward from the inner circumferential surface 30a of the main body portion 30 by a short distance. The protrusion height of the restricting protrusion 60 from the inner circumferential surface 30a is set to a height that allows it to abut against the stopper plate 58. The restricting protrusion 60 abuts against the stopper plate 58, thereby restricting the axial movement of the plunger 26A. That is, in the syringe 14A of this embodiment, the stopper plate 58 and the restricting protrusion 60 form a stopper structure 28A.

[0053] When plunger assembly 27 is rotated to align the circumferential position of notch 58a with the position of restricting protrusion 60, stopper plate 58 can pass through restricting protrusion 60, and the restriction on axial movement of plunger assembly 27 is released. Restricting protrusion 60 prevents movement of plunger assembly 27 toward the tip at a position where the volume of storage portion 38 (see FIG. 5B, etc.), which is liquid-tightly sealed by gasket 24, reaches a predetermined volume (e.g., 8 ml or 10 ml), thereby facilitating collection of a predetermined volume of liquid sample.

[0054] The syringe 14A of this embodiment has the same effects as the syringe 14 of FIG.

[0055] (Third embodiment) Syringe 14B of this embodiment shown in Figure 9A can be used in place of syringe 14 in Figure 1. In the description of this embodiment, only the main parts of syringe 14B will be described, and detailed description of other configurations will be omitted. In the configuration of syringe 14B, configurations similar to those of syringe 14 in Figure 1 will be assigned the same reference numerals, and detailed description thereof will be omitted.

[0056] The syringe 14B includes a plunger assembly 27 having a plunger 26B and a barrel body 22B. The plunger 26B has a pair of arms 62 that protrude radially outward at predetermined axial positions. The pair of arms 62 are spaced 180° apart in the circumferential direction. The arms 62 are long enough that their tips are positioned slightly outside the inner diameter of the main body 30 of the barrel body 22B. Therefore, the arms 62 are slightly curved inside the barrel body 22B. Due to their elastic restoring force, the arms 62 slide while constantly biased against the inner circumferential surface 30a of the main body 30.

[0057] The barrel body 22B has a first annular groove 64 and a second annular groove 66 at predetermined positions in the axial direction of the body portion 30. The first annular groove 64 and the second annular groove 66 are grooves formed to be recessed into the inner circumferential surface 30a of the body portion 30, and extend in annular shapes over the entire circumferential area. The first annular groove 64 and the second annular groove 66 have a width (axial dimension) that can accommodate the tip of the arm portion 62.

[0058] 9B, the first annular groove 64 and the second annular groove 66 engage with the arm portion 62 to restrict axial movement of the plunger assembly 27. When a user presses or pulls the plunger assembly 27, the arm portion 62 disengages from the first annular groove 64 or the second annular groove 66, and the restriction on axial movement of the plunger assembly 27 is released. In this way, the stopper structure 28B of this embodiment is formed by the first annular groove 64 and / or the second annular groove 66 and the arm portion 62.

[0059] 9B, the first annular groove 64 is positioned to engage with the arm portion 62 when the volume of the storage chamber 38 at the tip of the gasket 24 reaches a predetermined amount (e.g., 8 ml or 10 ml). The second annular groove 66 is formed in a position to engage with the arm portion 62 when the volume of the storage chamber at the tip of the gasket 24 reaches twice the predetermined amount (e.g., 16 ml or 20 ml). In this way, the syringe 14A of this embodiment restricts the movement of the plunger assembly 27 at a position corresponding to the collection amount of the culture bottle 90, thereby suppressing variation in the collection amount of the liquid sample.

[0060] The above-described embodiments of the present invention are summarized below.

[0061] A collection kit 10 according to one aspect comprises a connection tube 12 to which a medical bag containing a liquid sample can be connected, a syringe 14 that communicates with the connection tube and contains a predetermined amount of the liquid sample, and a sampling holder 16 that communicates with the syringe and to which a culture bottle 90 can be connected, wherein the syringe has a barrel body 22, a gasket 24 that slides inside the barrel body, and plungers 26, 26A, 26B attached to the gasket, the barrel body has a capacity capable of containing the amount of liquid sample to be collected in two of the culture bottles, and the syringe has stopper structures 28, 28A, 28B that abut against the plungers at predetermined positions and prevent the plungers from moving axially against the negative pressure of the culture bottles.

[0062] In the collection kit described above, the plunger is stopped by a stopper structure, so even an unskilled operator can easily collect a predetermined amount of liquid sample into the aerobic culture bottle 92 and the anaerobic culture bottle 94. This also eliminates the risk of air getting into the anaerobic culture bottle. Furthermore, because the entire volume of liquid sample in the syringe can be collected into the culture bottle without air getting mixed in, the amount of valuable liquid sample, such as platelet products, collected can be reduced.

[0063] The stopper structure may have a first uneven structure 25 formed on the plunger and a second uneven structure 23 formed on the barrel body and engaging with the first uneven structure of the plunger at a predetermined position, and the first uneven structure and the second uneven structure may engage with each other at an intermediate stop position where the syringe contains one amount of the liquid sample for the culture bottle, thereby releasably preventing movement of the plunger in the axial direction. This stopper structure stops the plunger when the transfer of one amount of liquid sample for the culture bottle is completed, so even an unskilled operator can collect an accurate amount of liquid sample into the culture bottle.

[0064] The first uneven structure may be a protrusion 26a protruding radially outward from the plunger, and the second uneven structure may be a guide rail 42 formed on the inner circumferential surface 40 of the barrel body and having a guide groove 46 that receives and slides the protrusion. The stopper structure 28 described above can reliably prevent the plunger 26 from moving in the axial direction with a simple configuration consisting of the guide groove 46 and the protrusion 26a.

[0065] The first concave-convex structure may be a protrusion protruding radially outward from the plunger, and the second concave-convex structure may be a guide groove 46A formed by cutting out the barrel body and allowing the protrusion to slide. This collection kit can achieve a stopper structure that releasably blocks axial movement of the plunger midway using a cutout structure that is easier to manufacture.

[0066] The guide groove may include a circumferential groove 46c extending in the circumferential direction, a first axial groove extending from one end of the circumferential groove toward the base end in the axial direction, and a second axial groove extending from the other end of the circumferential groove toward the tip end in the axial direction, and the circumferential groove may restrict movement of the plunger in the axial direction. The guide groove can prevent axial movement of the plunger at a predetermined position. Furthermore, the stopper structure having the guide groove releases the prevention of axial movement of the plunger by rotating the plunger.

[0067] The collection kit may further include an air vent 19 connected to the connecting tube for discharging air from the internal flow path. By using the air vent, this collection kit can easily discharge air from the flow path, thereby more effectively preventing air from entering the culture bottle.

[0068] The collection kit may further include a second tube 20 connected to the nozzle of the syringe, and a three-way stopcock 18 connecting the second tube, the connecting tube, the sampling holder, and the syringe, and the second tube may serve as both a path for transferring the liquid sample from the connecting tube to the syringe and a path for transferring the liquid sample from the syringe to the sampling holder. This collection kit can more effectively prevent the risk of air contamination when collecting a liquid sample in an anaerobic culture bottle, thereby reducing the risk of false positives in anaerobic culture tests.

[0069] The present invention is not limited to the above-described embodiment, and various configurations can be adopted without departing from the gist of the present invention. [Explanation of symbols]

[0070] 10...Collection kit 12...Connecting tube 14, 14A, 14B... Syringe 16... Sampling holder 18...Three-way stopcock 20...Second tube 22, 22A, 22B... Barrel body 23, 23A... Second uneven structure 24...Gasket 25...First uneven structure 26, 26A, 26B... Plunger 26a... Protrusion 28, 28A, 28B...Stopper structure 42...Guide rail 46...guide groove 46c...circumferential groove

Claims

1. a connecting tube to which a medical bag containing a liquid sample can be connected; a syringe communicating with the connecting tube and containing a predetermined amount of the liquid sample; a sampling holder that communicates with the syringe and to which a culture bottle can be connected; The syringe includes a barrel body, a gasket that slides inside the barrel body, and a plunger attached to the gasket, the barrel body has a volume capable of accommodating the amount of the liquid sample to be collected in the two culture bottles; The syringe comprises: a stopper structure including a first uneven structure formed on the plunger and a second uneven structure provided on the barrel body and engaging with the first uneven structure; the second uneven structure has a stopper formed of a groove or a protrusion in a part of the circumferential direction of the barrel body at an intermediate stop position where the syringe accommodates one amount of the liquid sample in the culture bottle, The first uneven structure engages with the stopper, thereby preventing the plunger from moving in the axial direction against the negative pressure of the culture bottle at the intermediate stop position; the stopper structure disengages the second concave-convex structure from the first concave-convex structure by rotating the plunger; Collection kit.

2. 10. The collection kit of claim 1, the first uneven structure is a protrusion protruding radially outward from the plunger, A collection kit, wherein the second uneven structure is a guide rail formed on the inner surface of the barrel body and having a guide groove that receives and slides the protrusion.

3. 10. The collection kit of claim 1, the first uneven structure is a protrusion protruding radially outward from the plunger, The second uneven structure is formed by cutting out the barrel body and has a guide groove that receives and slides the protrusion.

4. 4. The collection kit according to claim 2 or 3, wherein the guide groove is: a circumferential groove extending in a circumferential direction; a first axial groove extending from one end of the circumferential groove toward a base end in the axial direction; a second axial groove extending from the other end of the circumferential groove toward a tip end in the axial direction, The collection kit, wherein the circumferential groove restricts the axial movement of the plunger.

5. 5. The collection kit according to claim 1, further comprising an air vent connected to the connecting tube for discharging air from an internal flow path.

6. The collection kit according to any one of claims 1 to 5, a second tube connected to the nozzle of the syringe; a three-way stopcock that connects the second tube, the connecting tube, the sampling holder, and the syringe; The second tube serves as both a path for transferring the liquid sample from the connecting tube to the syringe and a path for transferring the liquid sample from the syringe to the sampling holder.

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