Collection kit and collection method
The sampling kit with parallel chambers and a switching mechanism addresses the challenges of inaccurate sample measurement and air contamination, ensuring precise collection and reducing waste in blood product testing.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Filing Date
- 2022-03-03
- Publication Date
- 2026-03-26
AI Technical Summary
Conventional collection kits face challenges in accurately measuring and transferring liquid samples due to rapid liquid level changes and the risk of air introduction during sample transfer, especially for inexperienced operators.
A sampling kit with a syringe having parallel first and second chambers, a switching mechanism, and a flow path connecting member, allowing precise measurement and separation of liquid samples into aerobic and anaerobic culture bottles, minimizing air contamination.
Enables accurate collection of predetermined liquid samples into culture bottles, reducing the risk of air introduction and minimizing waste of valuable blood products.
Smart Images

Figure 0007836192000001 
Figure 0007836192000002 
Figure 0007836192000003
Abstract
Description
Technical Field
[0001] The present invention relates to a collection kit and a collection method for collecting a blood preparation for inspection.
Background Art
[0002] In order to ensure the safety of blood preparations, a small amount of liquid sample is collected before the shipment of the blood preparation for a culture test. In the culture test, a predetermined amount of liquid sample (blood preparation) is collected into a culture bottle, and the culture bottle is stored for a predetermined period in a temperature environment of 30 to 40 °C suitable for the growth of bacteria, and then the growth of bacteria in the culture bottle is confirmed.
[0003] For collecting the liquid sample into the culture bottle, a dedicated collection kit is used. 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 in advance. Next, while confirming the transfer amount of the liquid sample with the scale of the sample collection tube, the liquid sample is transferred to the culture bottle.
Prior Art Documents
Patent Documents
[0004]
Patent Document 1
Summary of the Invention
Problems to be Solved by the Invention
[0005] In the conventional collection kit, the liquid level of the liquid sample in the collection bottle changes rapidly due to the suction by the negative pressure of the culture bottle. Therefore, it is difficult for an inexperienced operator to measure a certain amount of liquid sample into the culture bottle, and the amount of the liquid sample collected into the culture bottle may be excessive or insufficient. Further, in the conventional collection kit, when transferring the liquid sample to the anaerobic culture bottle, there is a risk that the user accidentally mixes air.
[0006] An object of the present invention is to solve the above-described problems. [Means for solving the problem]
[0007] One aspect of the following disclosure is a sampling kit comprising: a connecting tube to which a medical bag containing a liquid sample can be connected; a syringe having a first chamber for containing a predetermined amount of the liquid sample from the medical bag; a second chamber for containing the predetermined amount of the liquid sample; a sampling holder to which a culture bottle can be connected; and a flow path connecting member for connecting the connecting tube, the syringe, and the sampling holder, wherein the first chamber and the second chamber are arranged in parallel in the width direction of the syringe, and the syringe comprises a nozzle through which the liquid sample flows, and a switching mechanism for selectively connecting either the first chamber or the second chamber to the nozzle.
[0008] Another perspective is a sampling method using the sampling kit described above, comprising: a bag connection step of connecting the medical bag to the connecting tube; a first filling step of filling a predetermined amount of the liquid sample into the first chamber of the syringe; a second filling step of filling a predetermined amount of the liquid sample into the second chamber of the syringe; a bag separation step of detaching the medical bag from the connecting tube; a first sampling step of connecting an aerobic culture bottle to the sampling holder and collecting the liquid sample from the first chamber into the aerobic culture bottle; and a second sampling step of connecting an anaerobic culture bottle to the sampling holder and collecting the liquid sample from the second chamber into the anaerobic culture bottle. [Effects of the Invention]
[0009] The sampling kit and method described above allow even inexperienced operators to accurately measure and collect a precise amount of liquid sample into a culture bottle. Furthermore, the sampling kit and method described above reduce the risk of the user accidentally introducing air when transferring the liquid sample to the anaerobic culture bottle. [Brief explanation of the drawing]
[0010] [Figure 1] Figure 1 is a diagram showing the configuration of the sampling kit according to the first embodiment. [Figure 2] Figure 2A is a longitudinal cross-sectional view of the syringe in Figure 1, and Figure 2B is an exploded perspective view of the area near the tip of the syringe in Figure 1. [Figure 3] Figure 3A is a perspective view of the barrel body of the syringe shown in Figure 1, and Figure 3B is a perspective view showing the first plunger assembly and the second plunger assembly of the syringe shown in Figure 1. [Figure 4] Figure 4A is an explanatory diagram of the bag connection process in the sampling method using the sampling kit shown in Figure 1, and Figure 4B is an explanatory diagram of the syringe operation in the first containment process. [Figure 5] Figure 5A is an explanatory diagram of the second containment process, and Figure 5B is an explanatory diagram of the bag separation process. [Figure 6] Figure 6A is an explanatory diagram of the first sampling process, and Figure 6B is an explanatory diagram of the second sampling process. [Figure 7] Figure 7A is a cross-sectional view of the syringe according to the second embodiment, and Figure 7B is a perspective view of the area near the base end of the syringe in Figure 7A. [Figure 8] Figure 8A is a cross-sectional view of the tip area of the syringe according to the third embodiment, and Figure 8B is a perspective view of the tip area of the syringe in Figure 8A. [Figure 9] Figure 9 is an explanatory diagram showing a modified version of the syringe in Figure 1. [Modes for carrying out the invention]
[0011] (First Embodiment) The sample collection kit 10 according to this embodiment, shown in Figure 1, is used, for example, in facilities such as blood centers that manufacture blood products. Specifically, the sample collection kit 10 is used in culture tests to confirm the safety of blood products. The culture test involves culturing anaerobic bacteria and aerobic bacteria. Therefore, culture bottles 90 (see Figures 6A and 6B) are used for aerobic culture and anaerobic culture, respectively. The sample collection kit 10 is used to collect liquid samples, for example, platelet preparations, and to collect predetermined amounts (for example, 8 ml or 10 ml) into aerobic culture bottle 92 (Figure 6A) and anaerobic culture bottle 94 (Figure 6B).
[0012] As shown in Figure 1, the sampling kit 10 comprises a connecting tube 12, a syringe 14, a sampling holder 16, and a flow path connecting member 18. The connecting tube 12 is a translucent medical tube made of a thermoplastic resin such as polyvinyl chloride resin. The connecting tube 12 can be connected to other medical tubes without exposing its interior to the outside air by using a sterile joining device. In addition, the connecting tube 12 can be separated from other medical tubes and its end sealed without exposing its interior to the outside air by using a tube sealer.
[0013] The connecting tube 12 has an upstream first end 12a and a downstream second end 12b. The first end 12a is welded and sealed in its initial state (the state in which the product is initially provided). The second end 12b is connected to the flow path connecting member 18.
[0014] The syringe 14 comprises a barrel body 20, a switching mechanism 24, a nozzle portion 26, a first plunger assembly 28, and a second plunger assembly 30. The barrel body 20 is made of a transparent or translucent resin material. The barrel body 20 has a cylindrical tubular portion 32. The tubular portion 32 has a housing chamber 34 inside. The housing chamber 34 is a hollow portion that extends in the axial direction of the syringe 14. The housing chamber 34 opens at the base end of the tubular portion 32.
[0015] Note that, as shown in FIG. 9, the syringe 14 may further include a first sealing member 49a that connects the proximal end of the barrel body 20 and the first plunger assembly 28, and a second sealing member 49b that connects the proximal end of the barrel body 20 and the second plunger assembly 30. The first sealing member 49a and the second sealing member 49b are cylindrical members formed of a flexible resin sheet or the like. One end of the first sealing member 49a is connected to the proximal end of the barrel body 20, and the other end is connected to the proximal end of the first plunger assembly 28. One end of the second sealing member 49b is connected to the proximal end of the barrel body 20, and the other end is connected to the proximal end of the second plunger assembly 30.
[0016] The first sealing member 49a and the second sealing member 49b are formed in a bellows shape. The first and second sealing members 49a and 49b are deformed from a shape folded in a bellows shape according to the positions of the first and second plunger assemblies 28 and 30 to a shape extended in a cylindrical shape. That is, the first and second sealing members 49a and 49b follow the displacement of the first and second plunger assemblies 28 and 30 by stretching the bellows.
[0017] The first and second sealing members 49a and 49b seal the gaps between the first and second plunger assemblies 28 and 30 and the barrel body 20 from the outside air to maintain the sterility of the first and second accommodation chambers 34a and 34b. The sealing members 49a and 49b prevent the occurrence of false positives in inspections, which would result in contamination being assumed even though the blood preparation is sterile by preventing bacteria from adhering to the inner wall of the barrel body 20.
[0018] The barrel body 20 further has a partition wall 36 and a tip wall 38. The partition wall 36 extends linearly in the radial direction through the central axis of the barrel body 20 and is integrally connected to the cylindrical portion 32. The partition wall 36 extends in the axial direction within the range from the proximal end to the tip of the cylindrical portion 32. The partition wall 36 partitions the accommodation chamber 34 into a first accommodation chamber 34a and a second accommodation chamber 34b. Each of the first accommodation chamber 34a and the second accommodation chamber 34b has a semicircular shape when viewed from the proximal end side in the axial direction.
[0019] The tip of the partition wall 36 is integrally connected to the tip wall 38. The tip wall 38 is located at the tip of the cylindrical portion 32. The tip wall 38 closes off a portion of the tip of the first storage chamber 34a and the second storage chamber 34b. The tip wall 38 has an opening 40a that communicates with the first storage chamber 34a and an opening 40b that communicates with the second storage chamber 34b.
[0020] As shown in Figure 2B, the tip wall 38 has an outer peripheral end face 38a and a mounting portion 38b. The outer peripheral end face 38a has a surface perpendicular to the axis of the syringe 14. The outer peripheral end face 38a extends in an annular shape in the circumferential direction along the outer circumference of the barrel body 20. The mounting portion 38b protrudes cylindrically in the axial direction from the outer peripheral end face 38a. A screw groove 38c is formed on the outer part of the mounting portion 38b. The tip surface 38d of the mounting portion 38b has a smooth, flat surface. The tip surface 38d constitutes a sliding surface with respect to the switching mechanism 24. A semicircular opening 40a and a semicircular opening 40b are formed at the tip surface 38d. The opening 40a and the opening 40b are separated by a partition wall 36.
[0021] As shown in Figure 2A, the switching mechanism 24 is positioned at the tip of the barrel body 20. As shown in Figure 2B, the switching mechanism 24 has a disc-shaped rotating member 44. The rotating member 44 has a tip surface 44a and a base surface 44b, both of which are smooth, flat surfaces. As shown in Figure 2A, the base surface 44b slides in liquid-tight surface contact with the tip surface 38d of the mounting portion 38b and the partition wall 36. The base surface 44b has a pivot projection 44c at its center that positions the rotation center of the rotating member 44. The pivot projection 44c fits into the pivot recess 36a of the partition wall 36, forming a bearing structure for the rotating member 44. The tip surface 44a of the rotating member 44 slides in liquid-tight contact with the inner end surface 50b of the nozzle portion 26.
[0022] The rotating member 44 has a through hole 44f that penetrates the tip surface 44a and the base end surface 44b. The through hole 44f is positioned to communicate with openings 40a and 40b. When the rotating member 44 is rotated, the through hole 44f communicates with either opening 40a or opening 40b, depending on the rotation angle of the rotating member 44. In order to prevent communication with both openings 40a and 40b, the diameter of the through hole 44f is smaller than the thickness of the partition wall 36.
[0023] Multiple vertical grooves 44e are formed on the outer portion 44d of the rotating member 44. The outer portion 44d of the rotating member 44 having the vertical grooves 44e is exposed from the nozzle portion 26, as shown in Figure 3A. The user can rotate the rotating member 44 through the outer portion 44d having the vertical grooves 44e.
[0024] As shown in Figure 2A, the nozzle section 26 has a nozzle 46 and a manifold section 48. The manifold section 48 has a cylindrical recess 50 that accommodates a mounting section 38b and a rotating member 44. The inner circumferential surface 50a of the recess 50 has a screw structure 48b that screws into the screw groove 38c of the mounting section 38b. The recess 50 has an inner end surface 50b. When the manifold section 48 is attached to the mounting section 38b, the inner end surface 50b presses against the rotating member 44, sealing the rotating member 44 in a liquid-tight manner. A confluence section 26a is formed in the center of the manifold section 48. The confluence section 26a has a funnel shape that gradually decreases in diameter towards the tip. The confluence section 26a is always in communication with the through hole 44f. The tip of the confluence section 26a is in communication with the connecting passage 26b of the nozzle 46. The manifold portion 48 has a notch 48a formed by cutting out a part of its outer circumference. As shown in Figure 2B, a recess 50 is exposed in the notch 48a. As shown in Figure 3A, the outer portion 44d of the rotating member 44 is exposed through the notch 48a. The notch 48a, which exposes the outer portion 44d of the rotating member 44, constitutes the operating portion 25 of the switching mechanism 24 in this embodiment.
[0025] As shown in Figure 3B, the first plunger assembly 28 includes a first gasket 28a and a first plunger 28b. The first gasket 28a has a semicircular shape when viewed from the axial direction. As shown in Figure 2A, the first gasket 28a is housed in the first housing chamber 34a. The first gasket 28a slides axially in liquid-tight contact with the inner wall of the first housing chamber 34a. The first gasket 28a partitions the first housing chamber 34a, thereby forming a first chamber 52 within the first housing chamber 34a. The volume of the first chamber 52 changes depending on the position of the first gasket 28a. The first plunger 28b is assembled to the base end of the first gasket 28a. Upon receiving the user's operating force, the first plunger 28b displaces the first gasket 28a toward the tip or base end.
[0026] As shown in Figure 3B, the second plunger assembly 30 includes a second gasket 30a and a second plunger 30b. As shown in Figure 2A, the second gasket 30a is housed in the second containment chamber 34b. The second gasket 30a partitions the second containment chamber 34b, thereby forming a second chamber 54 within the second containment chamber 34b. The volume of the second chamber 54 changes depending on the position of the second gasket 30a. The position of the second gasket 30a is manipulated by the second plunger 30b. The second plunger assembly 30 is separate from the first plunger assembly 28 and displaces independently of the first plunger assembly 28.
[0027] The first plunger assembly 28 and the second plunger assembly 30 are located at the very tip in the initial state. The first gasket 28a and the second gasket 30a are in contact with the tip wall 38.
[0028] The sampling holder 16 has a holder portion 16a that accommodates the neck of the culture bottle 90 (see Figures 6A and 6B), a needle tube 16b that can penetrate the stopper of the culture bottle 90, and a lid 16c. The culture bottle 90 is connected to the sampling holder 16 by inserting the neck of the culture bottle 90 into the holder portion 16a. The needle tube 16b penetrates the stopper of the culture bottle 90 and communicates with the inside of the culture bottle 90. The lid 16c is attached to the holder portion 16a via a hinge. In its initial state, the lid 16c covers the opening of the holder portion 16a, thereby sealing the holder portion 16a. The lid 16c prevents bacteria from adhering to the needle tube 16b.
[0029] The flow path connecting member 18 selectively connects the connecting tube 12, the syringe 14, and the sampling holder 16. The flow path connecting member 18 is, for example, a three-way stopcock. In the first position, the flow path connecting member 18 connects the connecting tube 12 and the syringe 14, and prevents communication with the sampling holder 16. In the second position, the flow path connecting member 18 connects the syringe 14 and the sampling holder 16.
[0030] The sampling kit 10 of this embodiment is configured as described above. This sampling kit 10 is used in the following sampling method.
[0031] As shown in Figure 4A, the sampling method of this embodiment first proceeds to the bag connection step. This step involves connecting a medical bag 100 (platelet bag) containing platelet preparation to the connecting tube 12 of the sampling kit 10. This step includes the operation of joining the tube 102 extending from the medical bag 100 and the connecting tube 12 using a sterile joining device.
[0032] Next, as shown in Figure 4B, the sampling method proceeds to the first containment step. The first containment step is the step of containing a predetermined amount of liquid sample (for example, a platelet preparation) in the first chamber 52 of the syringe 14. Prior to the first containment step, the three-way stopcock of the flow path connecting member 18 is operated to connect the connecting tube 12 and the syringe 14. In addition, the rotating member 44 of the switching mechanism 24 is rotated to connect the connecting flow path 26b of the nozzle section 26 and the first chamber 52 of the syringe 14.
[0033] Next, the sampling method proceeds to the operation of retracting the first plunger assembly 28 to its base end. This operation causes the liquid sample to flow into the first chamber 52 through the through hole 44f, as shown in Figure 4B. The first sampling step is carried out until the first gasket 28a reaches a predetermined position. The first sampling step results in a predetermined amount (for example, 8 ml or 10 ml) of liquid sample being contained in the first chamber 52.
[0034] The first containment step may include an air bubble removal operation. The air bubble removal operation is performed by reciprocating the first plunger assembly 28 in the axial direction and compressing the connecting tube 12 (tube 102). To facilitate air bubble removal, it is preferable to position the medical bag 100 above the collection kit 10, as shown in Figure 4A.
[0035] After the first containment process is completed, the switching mechanism 24 is rotated to move the through-hole 44f to a position where it overlaps with the opening 40b of the second containment chamber 34b. This operation closes the first chamber 52 with the rotating member 44. Also, the second chamber 54 and the connecting flow path 26b are connected.
[0036] Next, as shown in Figure 5A, the sampling method proceeds to the second containment step. The second containment step is the step of containing a predetermined amount of liquid sample in the second chamber 54. This step includes the operation of retracting the second plunger assembly 30 to its base end. As a result of this operation, a predetermined amount (for example, 8 ml or 10 ml) of liquid sample is contained in the second chamber 54, as shown in the figure. Air bubbles may be removed during the second containment step. Air bubbles in the second chamber 54 are removed by methods such as moving the second plunger assembly 30 back and forth. While the second containment step is being performed, the amount of liquid sample contained in the first chamber 52 is kept constant.
[0037] Next, the collection method proceeds to the bag separation step. The bag separation step includes the operation of melting and cutting the connecting tube 12 using a tube sealer (not shown). The bag separation step separates the medical bag 100 (Figure 5A) from the collection kit 10, as shown in Figure 5B. The medical bag 100 separated from the collection kit 10 is stored at the blood center until the culture test is completed. The medical bag 100, whose safety of the blood product has been confirmed, is made available for use.
[0038] Next, as shown in Figure 6A, the sampling method proceeds to the first sampling step. The first sampling step is the step of collecting a predetermined amount of liquid sample into the first culture bottle 90. In the first sampling step, the liquid sample is collected into the aerobic culture bottle 92, which is used for aerobic culture, from among the culture bottles 90. Prior to the first sampling step, the three-way stopcock of the flow path connecting member 18 is moved to connect the syringe 14 and the sampling holder 16. In addition, the switching mechanism 24 is operated to connect the first chamber 52 and the connecting flow path 26b.
[0039] Subsequently, the first plunger assembly 28 is advanced toward the tip of the syringe 14. This operation collects the liquid sample from the first chamber 52 into the aerobic culture bottle 92. The first sampling process is completed when the first gasket 28a contacts the tip wall 38. While the first sampling process is being performed, the second chamber 54 is closed by the switching mechanism 24. Therefore, the volume of the second chamber 54 does not change.
[0040] In the first sampling step, a predetermined amount (8 ml or 10 ml) of liquid sample is collected in the aerobic culture bottle 92. In the first sampling step, any air bubbles remaining in the sampling holder 16 are drawn out into the aerobic culture bottle 92. Therefore, the first sampling step also serves as a priming step to replace the air inside the sampling holder 16 with the liquid sample. The first sampling step prevents air from being introduced into the anaerobic culture bottle 94 in the subsequent second sampling step.
[0041] Next, as shown in Figure 6B, after the completion of the first sampling step, the aerobic culture bottle 92 is removed from the sampling holder 16. The sampling method then proceeds to the second sampling step. The second sampling step is the step of collecting a liquid sample into the second culture bottle 90. The anaerobic culture bottle 94, which serves as the second culture bottle 90, is connected to the sampling holder 16.
[0042] The second sampling step then proceeds to an operation in which the second plunger assembly 30 is pressed toward the tip. This operation transfers the liquid sample contained in the second chamber 54 to the anaerobic culture bottle 94. The second sampling step ends when the second gasket 30a comes into contact with the tip wall 38. The second sampling step collects a predetermined amount (8 ml or 10 ml) of liquid sample into the anaerobic culture bottle 94.
[0043] Subsequently, the anaerobic culture bottle 94 is removed from the sampling holder 16, completing the sampling method using the sampling kit 10 of this embodiment. The aerobic culture bottle 92 and anaerobic culture bottle 94, from which the liquid samples have been collected, are subjected to culture testing.
[0044] As described above, the sample collection kit 10 and sample collection method of this embodiment allow even inexperienced users to collect an accurate amount of liquid sample by operating the syringe 14. Furthermore, since the syringe 14 has a first chamber 52 separated by a first gasket 28a and a second chamber 54 separated by a second gasket 30a, it is possible to prevent air from entering the culture bottle 90. Therefore, with the sample collection kit 10 and sample collection method, almost the entire amount of liquid sample collected in the syringe 14 can be used for culture testing, and the waste of valuable blood products (e.g., platelet preparations) can be reduced.
[0045] (Second Embodiment) The syringe 14A of this embodiment, shown in Figures 7A and 7B, can be used to replace the syringe 14 of the collection kit 10 (first embodiment) shown in Figure 1. In this description of the embodiment, illustrations and descriptions of syringes other than 14A are omitted.
[0046] As shown in Figures 7A and 7B, the syringe 14A has an operating knob 56 for rotating the switching mechanism 24. The operating knob 56 is connected to the base end of a shaft 58 that extends toward the base end along the rotation center of the rotating member 44. The shaft 58 penetrates the interior of the partition wall 36 and connects to the center of the rotating member 44. The base end of the shaft 58 protrudes from base end to base end of the partition wall 36. The shaft 58 transmits the rotational force of the operating knob 56 to the rotating member 44.
[0047] The rotating member 44 rotates around an axis along the shaft 58. In this embodiment, the manifold portion 48A of the nozzle portion 26A does not have a notch 48a, and the manifold portion 48A covers the entire circumference of the outer portion 44d of the rotating member 44. The rotating member 44 in this embodiment does not have a longitudinal groove 44e on the outer portion 44d.
[0048] The other components of syringe 14A are the same as those of syringe 14 in Figure 2A. Syringe 14A in this embodiment has improved operability because the rotating member 44 of the switching mechanism 24 can be rotated using the operating knob 56 that protrudes from the base end.
[0049] (Third embodiment) The syringe 14B of this embodiment, shown in Figures 8A and 8B, can be used to replace the syringe 14 of the collection kit 10 (first embodiment) shown in Figure 1. In this description of the embodiment, illustrations and descriptions of syringes other than syringe 14B are omitted.
[0050] Syringe 14B has a nozzle section 26B and a switching mechanism 24B at the tip of the barrel body 20B. The nozzle section 26B comprises a manifold section 48B and a nozzle 46. As shown in Figure 8B, the manifold section 48B has a spherical shape. As shown in Figure 8A, the manifold section 48B has a cylindrical housing space 60 that accommodates the rotating member 62. The housing space 60 extends in a direction perpendicular to the plane of the paper in Figure 8A.
[0051] As shown in Figures 8A and 8B, the switching mechanism 24B includes a cylindrical rotating member 62, a shaft 58B, and an operating part 64. The rotating member 62 is a cylindrical member extending in a direction perpendicular to the plane of the paper in Figure 8A. The rotating member 62 fills the entire area of the housing space 60 of the manifold section 48B without any gaps. The rotating member 62 has an outer peripheral surface 62b made of a cylindrical surface and rotates about an axis perpendicular to the plane of the paper in Figure 8A. The outer peripheral surface 62b is a sliding surface that slides in liquid-tight contact with the inner surface of the manifold section 48B and the lower end of the partition wall 36.
[0052] The rotating member 62 has a through hole 62a that extends radially from the center of rotation. The through hole 62a is bent at 120° at the center of rotation. In the state shown in Figure 8A, the through hole 62a connects the second chamber 54 and the nozzle 46, and the second chamber 54 is closed by the rotating member 62. When the rotating member 62 is rotated 120° counterclockwise from the state shown in Figure 8A, the rotating member 62 connects the first chamber 52 to the nozzle 46 through the through hole 62a and closes the second chamber 54.
[0053] As shown in Figure 8B, the shaft 58B extends from the rotating member 62 along the rotation center of the rotating member 62. The shaft 58B penetrates the manifold portion 48B and is exposed to the outside. The shaft 58B and the rotating member 62 are integrally connected, and the rotating member 62 rotates integrally with the shaft 58B. An operating portion 64 is formed at the end of the shaft 58B. The operating portion 64 consists of a lever that extends radially along the shaft 58B.
[0054] The other components of syringe 14B are the same as those of syringe 14 in Figure 2A. In this embodiment, syringe 14B allows the rotation of the rotating member 62 of the switching mechanism 24B to be performed by the operating part 64 that protrudes from the side.
[0055] The above embodiments can be summarized as follows.
[0056] One aspect of this embodiment is a sampling kit 10 comprising: a connecting tube 12 to which a medical bag 100 containing a liquid sample can be connected; a syringe 14 having a first chamber 52 for containing a predetermined amount of the liquid sample from the medical bag and a second chamber 54 for containing the predetermined amount of the liquid sample; a sampling holder 16 to which a culture bottle 90 can be connected; and a flow path connecting member 18 for connecting the connecting tube, the syringe, and the sampling holder, wherein the first chamber and the second chamber are arranged in parallel in the width direction of the syringe, and the syringe comprises a nozzle 46 through which the liquid sample flows, and switching mechanisms 24, 24A, and 24B for selectively connecting either the first chamber or the second chamber to the nozzle.
[0057] The above-described sample collection kit allows even inexperienced users to collect liquid samples in appropriate volumes for the first and second chambers into aerobic and anaerobic culture bottles. This minimizes variations in the amount of liquid sample collected and prevents the need for re-collection due to insufficient sample volume. Furthermore, because the liquid samples in the first and second chambers of the syringe are separated from the air, the sample collection kit prevents air from contaminating the culture bottles. Additionally, the sample collection kit allows for the use of nearly the entire volume of liquid sample collected in the syringe for culture testing, minimizing waste of valuable blood products (e.g., platelet preparations).
[0058] In the above sampling kit, the syringe may include a first gasket 28a that closes the base end of the first chamber, a first plunger 28b connected to the first gasket, a second gasket 30a that closes the base end of the second chamber, and a second plunger 30b connected to the second gasket. This sampling kit allows for the collection of precise amounts of liquid sample into two culture bottles by independently operating the plungers of each of the two chambers.
[0059] In the above-described sampling kit, the syringe may have a partition wall 36 that extends in the axial direction and divides the inside of the syringe into a first chamber and a second chamber. Since this sampling kit can form two chambers inside a single cylindrical syringe, the device configuration is made smaller and simpler, and handling is also improved.
[0060] In the sampling kit described above, the switching mechanism may have rotating members 44 and 62 that close the front ends of the first and second chambers, and each rotating member may have a sliding surface that rotates while in liquid-tight contact with the partition wall, and through holes 44f and 62a that connect the first or second chamber to the nozzle depending on the rotation position. This sampling kit enables the sampling of an accurate amount of liquid sample by preventing changes in the amount of liquid sample by closing the other chamber while operating the plunger of one chamber.
[0061] In the above-described sampling kit, the switching mechanism may have an operating section 25 in which the outer portion 44d of the rotating member is exposed. This sampling kit allows for miniaturization and reduction of manufacturing costs because the operating section can be realized with a simple structure.
[0062] In the above-described sampling kit, the switching mechanism may have shafts 58, 58B extending in the direction of the rotation center of the rotating member, and the shafts may have an operating section exposed to the outside of the syringe. Since the rotating member can be operated through the shafts in this sampling kit, the operating section can be placed in a location that is easy to handle.
[0063] In the above-described sampling kit, the shaft may extend through the interior of the partition wall towards the base end. This sampling kit offers excellent handling because the rotating member can be operated from the base end of the syringe.
[0064] Another perspective is a sampling method using the above-mentioned sampling kit, comprising: a bag connection step of connecting the medical bag to the connecting tube; a first filling step of filling a predetermined amount of the liquid sample into the first chamber of the syringe; a second filling step of filling a predetermined amount of the liquid sample into the second chamber of the syringe; a bag separation step of detaching the medical bag from the connecting tube; a first sampling step of connecting an aerobic culture bottle to the sampling holder and collecting the liquid sample from the first chamber into the aerobic culture bottle; and a second sampling step of connecting an anaerobic culture bottle to the sampling holder and collecting the liquid sample from the second chamber into the anaerobic culture bottle.
[0065] The above sampling method allows even inexperienced users to collect liquid samples in quantities corresponding to the volumes of the first and second chambers, respectively, into aerobic and anaerobic culture bottles. Furthermore, this sampling method reduces the risk of air bubbles contaminating the anaerobic culture bottles.
[0066] Furthermore, the present invention is not limited to the embodiments described above, and various configurations can be taken without departing from the spirit of the invention. [Explanation of symbols]
[0067] 10…Collection kit 12…Connecting tube 14, 14A, 14B... Syringe 16... Sampling holder 18…Flow path connecting member 24, 24A, 24B…Switching mechanism 25, 64...Operation panel 36...Partition wall 44, 62... Rotating member 44f, 62a... Through hole 46…Nozzle 52…First Chamber 54...Second Chamber Room 58, 58B...Shaft 90...Culture bottles 100...Medical bags
Claims
1. A connecting tube to which a medical bag containing a liquid sample can be attached, A syringe having a first chamber for containing a predetermined amount of the liquid sample from the medical bag, and a second chamber for containing a predetermined amount of the liquid sample, A sampling holder to which a culture bottle can be connected, The device comprises a flow path connecting member connected to the connecting tube, the syringe, and the sampling holder, and capable of selectively connecting any two of the connecting tube, the syringe, and the sampling holder, The first chamber and the second chamber are arranged in parallel in the width direction of the syringe. The syringe has a nozzle through which the liquid sample flows, The system includes a switching mechanism that selectively connects either the first chamber chamber or the second chamber chamber to the nozzle, The syringe is, A partition wall extending in the axial direction divides the inside of the syringe into the first chamber and the second chamber, A first gasket that closes the base end of the first chamber, A first plunger connected to the first gasket, A second gasket that closes the base end of the second chamber, It has a second plunger connected to the second gasket, The aforementioned switching mechanism is A rotating member is positioned between the tip of the first chamber and the tip of the second chamber and the nozzle, and closes the tip of the first chamber and the tip of the second chamber. It has an operating part for rotating the aforementioned rotating member, The aforementioned rotating member is A sliding surface that rotates while in liquid-tight contact with the partition wall, A sampling kit having a through hole that connects the first chamber chamber or the second chamber chamber to the nozzle depending on the rotational position.
2. A sampling kit according to claim 1, wherein the switching mechanism has an operating section that exposes the outer part of the rotating member.
3. A sampling kit according to claim 1, wherein the switching mechanism has a shaft extending in the direction of the rotation center of the rotating member, and the shaft has an operating part exposed to the outside of the syringe.
4. A sampling kit according to claim 3, wherein the shaft penetrates the interior of the partition wall and extends toward the base end.
5. A sampling method using the sampling kit described in any one of claims 1 to 4, A bag connection step involves connecting the medical bag to the connecting tube, The first filling step involves positioning the through-hole at the tip of the first chamber to connect the first chamber and the nozzle, and filling the first chamber of the syringe with a predetermined amount of the liquid sample. The second storage step involves positioning the through-hole at the tip of the second chamber to connect the second chamber and the nozzle, and storing the predetermined amount of the liquid sample in the second chamber of the syringe. After the first and second storage steps, a bag separation step is performed to detach the medical bag from the connecting tube, The first sampling step involves positioning the through-hole at the tip of the first chamber to connect the first chamber and the nozzle, connecting an aerobic culture bottle to the sampling holder, and collecting the liquid sample from the first chamber into the aerobic culture bottle. A second sampling step involves positioning the through-hole at the tip of the second chamber to connect the second chamber and the nozzle, connecting an anaerobic culture bottle to the sampling holder, and collecting the liquid sample from the second chamber into the anaerobic culture bottle. A collection method having the following characteristics.
Citation Information
Patent Citations
Fluid transfer device, system, and method
JP2019132277A
Sampling kit and sampling method
JP2023128166A
Device system and method for fluid sample collection
US20190200908A1
Sterile sampling methods and apparatus
US8777921B2
Container for testing blood and blood sampling instrument
WO2013137359A1