Drug infusion kit
The drug transfer kit addresses handling errors in drug transfer processes by incorporating a vial connection section with separation and transition prevention mechanisms, enhancing operational reliability and reducing errors in drug handling.
Patent Information
- Application Number
- JP2021170436
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Filing Date
- 2021-10-18
- Publication Date
- 2025-12-16
- Estimated Expiration
- 2041-10-18
AI Technical Summary
Existing drug transfer processes, particularly for forming emulsions, are prone to handling errors such as incorrect vial selection, mixing up drugs, and operational mistakes due to the complexity of attaching and detaching transfer needles, which can lead to incorrect drug mixing and handling errors.
A drug transfer kit with a vial connection section that includes a first member with a needle and a second member with a vial fixing section, featuring separation prevention, transition restriction, and return prevention mechanisms to ensure correct vial attachment and prevent unintended electrical conduction, packaged in a connected state to minimize operational errors.
The kit significantly reduces the likelihood of vial handling errors by ensuring correct vial attachment and preventing unintended transitions or separations, improving operational reliability and reducing the risk of drug mixing mistakes during transportation and use.
Smart Images

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Abstract
Description
[Technical Field]
[0001] The present disclosure relates to a drug transfer kit. [Background technology]
[0002] Various medications are used in medical settings. Many of these medications are contained in vials as dry powders. Therefore, when using a medication, it is common to inject a dissolving solution from a syringe into a vial through a transfer needle, dissolve the medication in the vial, and then transfer the dissolved medication into the syringe through a transfer needle.
[0003] The drug transferred into the syringe may be used as is, or may be further processed before use. For example, the drug may be used in the form of an emulsion. One method for forming an emulsion involves transferring an aqueous drug and an oily drug into separate syringes, connecting the syringes to both ends of an emulsifying filter, which is a porous filter, and mixing the drugs together through the emulsifying filter (see, for example, Patent Document 1). Using an emulsifying filter makes it possible to form an emulsion from a small amount of drug. [Prior art documents] [Patent documents]
[0004] [Patent Document 1] Japanese Patent Application Laid-Open No. 2005-186026 Summary of the Invention [Problem to be solved by the invention]
[0005] However, forming an emulsion using the drug emulsification filter described above poses various problems. First, there is a problem with transferring the drug into a syringe. Transferring a drug from a vial to a syringe requires a series of steps: selecting a vial containing the required drug, attaching a transfer needle to the syringe, and using the attached syringe to transfer the drug solution from the vial to the syringe. This procedure can be fraught with various problems, such as incorrect vial selection and the complicated process of attaching and detaching the transfer needle. Misselection of a vial not only involves selecting the wrong type of drug, but also frequently involves mistaking a used, empty vial for an unused one.
[0006] Even if the transfer of the drug into the syringe is completed without any problems, there is a risk of mixing up the drugs in subsequent processing when handling multiple drugs. For example, in emulsification processing, water-based and oil-based drugs must be mixed in the correct order to create a W / O emulsion or an O / W emulsion, so it is important to avoid mixing up the drugs. Although it is sometimes possible to distinguish the type of drug by appearance, this is not a reliable method.
[0007] By bundling the various instruments used for infusion, the instruments used for post-infusion processing, and the vials containing the drugs in a kit, it is expected that mistakes in selecting drugs can be prevented. However, because the final installation of the vials must be performed by the operator, the effectiveness in preventing mistakes such as selecting the wrong vial or installing the vial in the wrong position is limited.
[0008] The object of the present disclosure is to realize a highly reliable drug transfer kit that is less likely to cause handling errors in a transfer device that handles vials. [Means for solving the problem]
[0009] A first aspect of the drug solution transfer kit of the present disclosure comprises a transfer section having a plurality of vials in which a drug is sealed and a plurality of connection ports to which corresponding specific vials are connected, through which the drug is transferred, and a vial connection section connecting the transfer section to the vials, the vial connection section having a first member having a needle that is punctured into the stopper of the vial and connected to the transfer section, and a second member having a vial fixing section that is fixed to the vial and connected to the first member by a connecting section, the connecting section having a separation prevention section that prevents the connection between the first member and the second member from being released, a transition restriction section that restricts the transition from a non-conductive state in which the needle and the vial are not conductive to a conductive state in which the needle and the vial are conductive, and a return prevention section that prevents the kit from returning from the conductive state to the non-conductive state, and the kit is packaged in a state in which at least a portion of the transfer section and the plurality of vials are connected.
[0010] The drug infusion kit of the first aspect is packaged with the infusion section and multiple vials connected. This prevents the operator from mixing up drugs or attaching vials in the wrong position. Furthermore, the separation prevention section prevents the vials from coming off during transportation or storage, or from being accidentally removed by the operator. The transfer limiting section prevents electrical conduction between the needle and vial during transportation or storage. Furthermore, the return prevention section prevents electrical conduction between the needle and vial from being broken due to incorrect operation during operation of a device to which multiple vials are connected.
[0011] In each embodiment of the drug solution transfer kit, the second member may have a gripping portion that protrudes axially outward from the bottom surface of the vial. This configuration guides the operator to grip the gripping portion rather than the vial when connecting the vial connection portion or during transfer operations. This improves operability and also reduces the risk of vial damage, thereby improving reliability.
[0012] In each embodiment of the drug solution transfer kit, the second member may be fitted inside the first member. This configuration allows the outer first member to be easily grasped, thereby guiding the operator not to grasp and operate the transfer unit rather than the first member. This reduces the likelihood of damage caused by excessive force being applied to the connection between the first member and the transfer unit. Furthermore, the operator can operate the kit with the feeling that they are connecting a vial by pushing the inner second member into the first member, making the operation less likely to feel strange and reducing the likelihood of operational errors.
[0013] In each aspect of the drug solution transfer kit, the connecting portion has an axially extending, elastically deformable arm portion provided on one of the first and second members, and an axially extending groove portion that receives the arm portion provided on the other member, and the separation preventing portion, migration restricting portion, and return preventing portion each have an arm-side protrusion portion provided on the arm portion and a groove-side protrusion portion formed in the groove portion, and the separation preventing portion and return preventing portion are configured so that the arm-side protrusion can climb over the groove-side protrusion in the direction in which the needle and vial approach each other, but prevent climbing over in the opposite direction, and the migration restricting portion is configured so that, when grasped, the arm-side protrusion can climb over the groove-side protrusion in the direction in which the needle and vial approach each other.
[0014] In this configuration, the transition from the non-conductive state to the conductive state can be completed by a unidirectional action of grasping the transition limiting portion and pressing it in the direction in which the needle and vial approach each other, allowing the operator to operate without confusion and reducing the occurrence of errors. Furthermore, because the transition to the conductive state does not occur unless the transition limiting portion is grasped, unintended transitions are less likely to occur, improving reliability. Meanwhile, the separation prevention portion and return prevention portion are configured to be able to overcome the gap in the direction in which the needle and vial approach each other but to prevent them from overcoming each other in the opposite direction. Therefore, the prevention of separation and return occurs automatically after connection and transition, simplifying operation and reducing the likelihood of operational errors.
[0015] In this case, the connecting portion may have a plurality of arms, and the transition limiting portion may be formed on an arm different from the arms constituting the separation preventing portion and the return preventing portion. With this configuration, the transition limiting portion is independent of the separation preventing portion and the return preventing portion, which further improves the reliability of the transition limiting portion.
[0016] In each aspect of the drug solution transfer kit, the connecting portion has a convex portion provided on one of the first member and the second member, and a groove portion that receives the convex portion provided on the other member, and the groove portion has a first groove portion extending in the axial direction, a second groove portion extending in the circumferential direction from one end of the first groove portion, a third groove portion extending in the diagonal direction from an end of the second groove portion opposite to the first groove portion, and a fourth groove portion extending in the circumferential direction from an end of the third groove portion opposite to the second groove portion, and Between the second groove portion there is a first blocking portion which allows the convex portion to climb over from the first groove portion side to the second groove portion side but prevents climbing over in the opposite direction, and between the third groove portion and the fourth groove portion there is a second blocking portion which allows the convex portion to climb over from the third groove portion side to the fourth groove portion side but prevents climbing over in the opposite direction, and the separation blocking portion may be constituted by the first blocking portion, the transition limiting portion may be constituted by the second groove portion, and the return blocking portion may be constituted by the second blocking portion.
[0017] With this configuration, the transition from a non-conductive state to a conductive state can be achieved by rotating the second member relative to the first member in one direction, which reduces the likelihood of operator confusion or mistakes. Furthermore, the second member is unlikely to rotate relative to the first member naturally, which sufficiently limits the transition from a non-conductive state to a conductive state. Furthermore, because the operation is performed in a different direction from the operation for connecting the first and second members, mistakes such as accidentally connecting the members to a conductive state during connection can be reduced.
[0018] In this case, the second member is cylindrical and fits into the first member, and the groove is formed on the outer surface of the cylindrical wall of the second member, and the cylindrical wall has a slit so that it can bend radially inward. With this configuration, the cylindrical wall with the groove formed therein can bend, allowing the protrusion to move smoothly.
[0019] A second aspect of the drug transfer kit of the present disclosure comprises a vial in which a drug is sealed, a transfer section for transferring the drug, and a vial connection section for connecting the transfer section to the vial, wherein the vial connection section has a first member having a needle that is punctured into the stopper of the vial and connected to the transfer section, and a second member having a vial fixing section that is fixed to the vial and connected to the first member by a connecting section, wherein the connecting section has a separation prevention section that prevents the connection between the first member and the second member from being released, and a transition restriction section that restricts the transition from a non-conductive state in which the needle and the vial are not conductive to a conductive state in which the needle and the vial are conductive, and when fixed to the vial, the end of the second member opposite the first member is located beyond the midpoint between the mouth and bottom of the vial toward the bottom.
[0020] The drug transfer kit of the second embodiment has a separation prevention part, which prevents the vial from coming off during transportation or storage, or from being accidentally removed by the operator. The transfer restriction part prevents electrical conduction between the needle and the vial during transportation or storage. Furthermore, when fixed to the vial, the end of the second member opposite the first member is located beyond the midpoint between the mouth and bottom of the vial toward the bottom. This allows the second member to protect the vial, and the kit can be easily transported or stored with the transfer part and vial connected. [Effects of the Invention]
[0021] According to the drug transfer kit of the present disclosure, it is possible to realize a highly reliable drug transfer kit that is less likely to cause vial handling errors. [Brief explanation of the drawings]
[0022] [Figure 1] FIG. 1 is a plan view showing a drug transfer kit according to one embodiment. [Figure 2] FIG. 1 is a perspective view showing a vial connection part according to one embodiment. [Figure 3] FIG. 2 is a perspective view showing a first member according to one embodiment. [Figure 4] FIG. 4 is a perspective view showing a second member according to one embodiment. [Figure 5] FIG. 1 is a cross-sectional view showing a vial connection portion according to one embodiment in a non-conductive state. [Figure 6] 10A-10C are cross-sectional views of one embodiment of a vial connection portion in a non-conducting state, taken from different angles. [Figure 7] FIG. 10 is a cross-sectional view showing a vial connection part according to one embodiment in a conductive state. [Figure 8] 10A-10C are cross-sectional views of one embodiment of a vial connection portion in a conductive state, taken at different angles. [Figure 9] FIG. 10 is a perspective view showing a vial connection part according to a modified example. [Figure 10] FIG. 10 is a perspective view showing a first member according to a modified example. [Figure 11] FIG. 10 is a perspective view showing a second member according to a modified example. [Figure 12] FIG. 12 is a cross-sectional view taken along line XII-XII in FIG. [Figure 13] FIG. 13 is a cross-sectional view taken along line XIII-XIII in FIG. [Figure 14] FIG. 14 is a cross-sectional view taken along line XIV-XIV in FIG. [Figure 15] FIG. 10 is a cross-sectional view showing a vial connection part according to a modified example in a non-conductive state. [Figure 16] 10A and 10B are cross-sectional views of a modified vial connection portion in a non-conductive state, taken from different angles. [Figure 17] FIG. 10 is a cross-sectional view showing a vial connection portion according to a modified example in a conductive state. [Figure 18] 10A and 10B are cross-sectional views of a modified vial connection portion in a conductive state, taken at different angles. DETAILED DESCRIPTION OF THE INVENTION
[0023] 1, a drug transfer kit 100 according to one embodiment includes a vial 105 containing a drug, a transfer section 106 into which the drug is transferred, and a vial connection section 101 that connects the transfer section 106 to the vial 105. The drug transfer kit 100 is packaged in packaging material 107 with the transfer section 106 and the vial 105 connected by the vial connection section 101.
[0024] The transfer unit 106 may be any device into which a drug is transferred. For example, it may be a single syringe. Furthermore, the transfer unit 106 may not be the entire device into which a drug is transferred, but may be only a part of it. In FIG. 1, the transfer unit 106 is exemplified by a four-way stopcock of a drug emulsification device having two connection ports for connecting vials and two connection ports for connecting syringes. In the case of a drug emulsification device, for example, a syringe is connected to one of the connection ports for connecting syringes via an emulsification filter. Furthermore, vials containing specific drugs according to the process are connected to the two connection ports for connecting vials. Note that while FIG. 1 shows an example in which the syringe and emulsification filter are packaged in a disconnected state, they may also be packaged in a state in which at least a part of them are connected. While FIG. 1 shows an example in which two vials 105 are connected to the transfer unit 106, the number of vials 105 connected to the transfer unit 106 may be one, or three or more. In addition, the configuration is not limited to one in which all vials 105 are packaged in a state in which they are connected to the transfer unit 106. For example, one of the two vials 105 may be configured to be connected to the transfer unit 106 by an operator. In addition, the configuration is not limited to one in which all vials 105 are connected to the transfer unit 106 via the connection unit 101.
[0025] The packaging material 107 may be any material capable of packaging the drug infusion kit 100. For example, it may be a container such as a bag, a box, or a blister pack. A cushion or the like may be provided to prevent the drug infusion kit 100 from moving within the packaging material 107. Furthermore, the interior of the packaging material 107 may be kept sterile. When the infusion section 106 is connected to other instruments, etc., these instruments, etc. may be stored within the packaging material 107 in a state separate from the infusion section 106. They may also be packaged separately outside the packaging material 107.
[0026] 2, the vial connection part 101 has a first member 111 connected to the transfer part 106, and a second member 112 fixed to the vial 105 and connected to the first member 111. The connecting part connecting the first member 111 and the second member 112 has a first member side connecting part 133 formed on the first member 111 side, and a second member side connecting part 143 formed on the second member 112 side. Hereinafter, the side of the transfer part 106 may be referred to as the tip side, and the side opposite the transfer part 106 may be referred to as the base side.
[0027] As shown in FIG. 3 , the first member 111 has a top plate 135 at its distal end and is cylindrical with an open base end. A transfer needle 137 is formed through the top plate 135. The transfer needle 137 has a needle portion 138 extending into the cylinder and a connector portion 139 extending out of the cylinder. The transfer needle 137 has a liquid passage and an air passage connecting the needle portion 138 and the connector portion 139 therein. The connector portion 139 has a female luer portion that connects to a male luer connector, which is a connection port formed in the transfer portion 106, and an air vent filter 161 exposed to the outside. The liquid passage communicates with the female luer portion, and the air vent filter 161. This allows for easy injection of a medicinal liquid into the sealed vial 105 or extraction of the medicinal liquid from the vial 105.
[0028] A side wall 136 of the first member 111 surrounds the needle portion 138. This makes it difficult for the needle portion 138 to become contaminated or for the operator to be injured by the needle portion 138. The side wall 136 has a first connecting groove 131 and a second connecting groove 132 that extend axially on the inner surface. The first connecting groove 131 and the second connecting groove 132 function as a first member side connecting portion 133 for connecting the second member 112.
[0029] As shown in FIG. 4 , the second member 112 has a ring-shaped portion 144 in the shape of a C-ring with a portion of its circumference cut out, a first arm portion 141 and a second arm portion 142 extending from the ring-shaped portion 144 toward the base end, and a vial fixing claw 145 extending from the ring-shaped portion 144 toward the tip end. The first arm portion 141 and the second arm portion 142 are formed at positions corresponding to the first connecting groove 131 and the second connecting groove 132 in the circumferential direction. Therefore, the first arm portion 141 and the second arm portion 142 can slide along the first connecting groove 131 and the second connecting groove 132. The first arm portion 141 and the second arm portion 142 function as a second-member-side connecting portion 143 that is connected to the first-member-side connecting portion 133. In this embodiment, the radial thickness of the first arm portion 141 and the second arm portion 142 is thinner than the radial thickness of the ring-shaped portion 144, and can bend radially more easily than the ring-shaped portion 144, making sliding movement even easier.
[0030] A groove-side first convex portion 151 is formed in the first connecting groove 131, and a groove-side second convex portion 152 is formed in the second connecting groove 132. An arm-side first protrusion portion 155 and an arm-side third protrusion portion 157 are formed in the first arm portion 141, and an arm-side second protrusion portion 156 is formed in the second arm portion 142.
[0031] The arm-side first protrusion 155 is formed closer to the tip than the arm-side third protrusion 157. In this embodiment, the arm-side first protrusion 155 is formed at the connection portion between the first arm portion 141 and the ring-shaped portion 144, and the arm-side third protrusion 157 is formed at the open end of the first arm portion 141. The arm-side second protrusion 156 is cantilevered with its open end located closer to the tip than the fixed end, and the open end is located between the arm-side first protrusion 155 and the arm-side third protrusion 157.
[0032] In this embodiment, the groove-side first convex portion 151 has a tip side surface on the top plate 135 side that rises approximately vertically radially inward, and a base side surface on the opposite side from the top plate 135 that forms an inclined surface that gradually protrudes radially inward toward the tip side. Also, the arm-side first protrusion 155 and the arm-side third protrusion 157 have tip side surfaces on the ring-shaped portion 144 side that form inclined surfaces that gradually protrude radially outward toward the base end side, and a base side surface on the opposite side from the ring-shaped portion 144 that rises approximately vertically radially outward.
[0033] The base end side surface of the groove-side second convex portion 152 is a substantially vertical surface that rises radially inward, so that the open end of the cantilever-shaped arm-side second protrusion 156 can be brought into contact with the base end surface of the groove-side second convex portion 152 without shifting.
[0034] As shown in FIGS. 5 to 8 , the first member 111 and the second member 112 can be connected by inserting the second member 112 attached to the vial 105 into the opening on the proximal end side of the first member 111. When inserting the second member 112 into the opening, the first arm portion 141 and the second arm portion 142 are aligned with the first connecting groove 131 and the second connecting groove 132, respectively. When the second member 112 is pressed toward the distal end side relative to the first member 111 and moved, the distal end side surface of the arm-side first protrusion 155 abuts against the proximal end side surface of the groove-side first protrusion 151. In this case, because the oblique end surfaces abut against each other, the arm-side first protrusion 155 can easily move over the groove-side first protrusion 151 toward the distal end.
[0035] On the other hand, because the base-end side surface of the arm-side first protrusion 155 and the tip-end side surface of the groove-side first protrusion 151 are both surfaces that rise approximately perpendicular to the radial direction, the arm-side first protrusion 155 cannot easily climb over the groove-side first protrusion 151 to the base-end side. For this reason, the groove-side first protrusion 151 and the arm-side first protrusion 155 function as a separation prevention portion that prevents the connection between the first member 111 and the second member 112 from being released. In addition, when the arm-side first protrusion 155 climbs over the groove-side first protrusion 151, a sense of resistance is imparted to the operator, and therefore, this also has the function of making the operator aware that the first member 111 and the second member 112 have been connected.
[0036] When the arm-side first protrusion 155 climbs over the groove-side first protrusion 151, the arm-side second protrusion 156 comes into contact with the base end surface of the groove-side second protrusion 152. The base end surface of the groove-side second protrusion 152 stands approximately perpendicularly inward in the radial direction. The arm-side second protrusion 156 is cantilevered, and its open end surface is formed approximately parallel to the base end surface of the groove-side second protrusion 152. Therefore, even if the second member 112 is pressed toward the tip side, the arm-side second protrusion 156 cannot easily climb over the groove-side second protrusion 152. On the other hand, the cantilevered arm-side second protrusion 156 bends radially inward when gripped, so the engagement between the arm-side second protrusion 156 and the groove-side second protrusion 152 is easily released. Therefore, the second member 112 can be moved toward the tip side relative to the first member 111 by a one-way operation of grasping the arm-side second protrusion 156 and pressing it in the axial direction.
[0037] At the position where the arm-side second protrusion 156 and the groove-side second protrusion 152 abut, the needle portion 138 of the transfer needle 137 is in a non-conductive state, not pierced by the stopper 163 that seals the opening of the vial 105. When the arm-side second protrusion 156 is grasped to release the engagement with the groove-side second protrusion 152 and the second member 112 is moved toward the tip side relative to the first member 111, the needle portion 138 pierces the stopper 163, and the transfer needle 137 and the vial 105 are brought into a conductive state. Therefore, the arm-side second protrusion 156 and the groove-side second protrusion 152 function as a transition limiting portion that limits unintended transition from a non-conductive state to a conductive state.
[0038] As the second member 112 moves toward the distal end relative to the first member 111, the distal end side surface of the arm-side third protrusion 157 comes into contact with the proximal end side surface of the groove-side first protrusion 151. Because the oblique end surfaces come into contact with each other, the arm-side third protrusion 157 can easily climb over the groove-side first protrusion 151 toward the distal end. Therefore, the arm-side third protrusion 157 and the groove-side first protrusion 151 do not hinder the transition from the non-conductive state to the conductive state. Furthermore, upon completion of the transition operation, the arm-side third protrusion 157 automatically climbs over the groove-side first protrusion 151.
[0039] On the other hand, the base-end side surface of the arm-side third protrusion 157 and the tip-end side surface of the groove-side first protrusion 151 are both substantially vertical end surfaces that rise in the radial direction. For this reason, the arm-side third protrusion 157 cannot easily climb over the groove-side first protrusion 151 to the base-end side. Therefore, the groove-side first protrusion 151 and the arm-side third protrusion 157 function as a return-blocking portion that prevents the conductive state from returning to the non-conductive state. In addition, the arm-side third protrusion 157 provides a sense of resistance to the operator when climbing over the groove-side first protrusion 151, thereby also functioning to let the operator know that the transition to the conductive state has been completed.
[0040] The vial connection unit 101 of this embodiment has a separation prevention portion, so once the second member 112 is connected to the first member 111, it cannot normally be removed. Furthermore, because it has a transfer restriction portion, it normally does not transition from a non-conductive state to a conductive state unless intentionally operated. Therefore, the vial 105 can be transported and stored while connected to the infusion unit 106 via the vial connection unit 101. By using the vial connection unit 101 of this embodiment, a drug infusion kit in which the vial 105 containing a predetermined drug is pre-connected to a predetermined position on the infusion unit 106 can be shipped from the factory. This eliminates the need to connect the vial on-site, improving operability and reducing the risk of misconnection. In particular, when connecting multiple vials 105 to a single infusion unit 106, the effort required for the connection operation and the risk of misconnection can be significantly reduced.
[0041] Furthermore, since the vial connection part 101 of this embodiment has a return prevention part, once it is in a conductive state it cannot be returned to a non-conductive state, which significantly reduces the risk of mistaking a removed and left-behind used vial for an unused one, or of accidentally returning it to a non-conductive state during a transfer operation and causing a transfer failure.
[0042] In the vial connection part 101 of this embodiment, two first arms 141 are formed facing each other across the central axis. This allows the second member 112 to be easily inserted parallel to the first member 111 with the axial direction aligned, improving assembly. Furthermore, unless both of the two separation prevention parts are released by breaking or the like, the first member 111 and the second member 112 will not separate, ensuring high reliability. However, the separation prevention parts may be one set, or three or more sets.
[0043] In the vial connection part 101 of this embodiment, the engagement between the arm-side second protrusion 156 and the groove-side second protrusion 152 is released by gripping the cantilever-shaped arm-side second protrusion 156 with the fingers. The action of gripping the cantilever-shaped arm-side second protrusion 156 with the fingers to release the engagement is unlikely to occur accidentally, so it is unlikely that the engagement between the arm-side second protrusion 156 and the groove-side second protrusion 152 will be unintentionally released. On the other hand, the action of gripping and pressing is a linear, unidirectional operation, so it is unlikely that the operator will make a mistake or take time to do so. This makes it less likely that the operator will make an operational error.
[0044] The vial connector 101 of this embodiment automatically becomes non-conductive when the second member 112 is connected to the first member 111, and the operation of transitioning from the non-conductive state to the conductive state can be performed without any preparatory operation. This greatly improves operability.
[0045] In this embodiment, the arm-side second protrusion 156 is cantilevered, so that the arm-side second protrusion 156 itself bends along with the second arm portion 142, allowing for greater radial displacement of the open end position. This increases the operating margin required to release the engagement with the groove-side second protrusion 152, making it less likely for malfunctions to occur. Meanwhile, the release operation itself can be easily performed without applying a large amount of force. However, the arm-side second protrusion 156 is not limited to a cantilevered configuration, and can have other structures that allow it to be gripped to engage with and release from the groove-side second protrusion 152.
[0046] In this embodiment, two sets of second connecting grooves 132 and second arms 142 are formed facing each other across the central axis, and two sets of transition limiting portions are formed. Therefore, when the two transition limiting portions are operated simultaneously, a transition from a non-conductive state to a conductive state can be made. This makes it even less likely that an unintended transition to a conductive state will occur, further improving reliability. Furthermore, when transitioning to a conductive state, two opposing locations are grasped, making it easier to apply a force that presses the second member 112 toward the distal end, improving operability. However, the number of transition limiting portions is not limited to two, and it can also be one set, or three or more sets.
[0047] In the vial connection part 101 of this embodiment, when the second member 112 is connected to the first member 111 to establish a non-conductive state, the base end of the first arm portion 141 is positioned closer to the tip end than the base end of the first connecting groove 131, making the first arm portion 141 unable to be operated from the outside. This makes it extremely difficult to perform irregular operations to release the connection between the first member 111 and the second member 112, achieving higher reliability. As a specific configuration for containing the first arm portion 141 in the first connecting groove 131 and preventing it from being exposed, in this embodiment, the side wall 136 of the first member 111 protrudes further toward the base end than the portion where the second connecting groove 132 is formed, at the portion where the first connecting groove 131 is formed. Furthermore, the groove-side first protrusion 151 is formed at a position shifted toward the tip end than the base end of the first connecting groove 131.
[0048] In the vial connecting part 101 of this embodiment, the arm-side third protrusion 157 constituting the return preventing part is formed on the first arm part 141 together with the arm-side first protrusion 155 constituting the separation preventing part. Therefore, the corresponding structure on the first member 111 side can also be the first connecting groove 131 and groove-side first protrusion 151 common to the separation preventing part, thereby simplifying the structure of the vial connecting part 101. However, the return preventing part can also be formed by an independent arm part different from the separation preventing part, or by the same arm part as the transition limiting part. Furthermore, the separation preventing part, transition limiting part, and return preventing part can also be formed by the same arm part.
[0049] In this embodiment, the first connecting groove 131 and the second connecting groove 132 are formed in a rib 134 that protrudes radially outward from the side wall 136 and extends in the axial direction. With this configuration, the grooves can be formed without increasing the thickness of the side wall 136, improving the moldability of the first member 111. The rib 134 also improves the strength of the first member 111, making it less susceptible to deformation.
[0050] In this embodiment, the first groove-side convex portion 151 is formed in the first connecting groove 131, thereby preventing the first arm-side protrusion 155 and the third arm-side protrusion 157 from returning to the base end side. However, other configurations are also possible as long as they can prevent the first arm-side protrusion 155 and the third arm-side protrusion 157 from returning to the base end side. For example, a configuration may be adopted in which a recess or an opening is formed in the first connecting groove 131, into which the first arm-side protrusion 155 and the third arm-side protrusion 157 fit. However, a configuration in which the first arm-side protrusion 155 and the third arm-side protrusion 157 are not exposed to the outside is preferable, as this reduces the possibility of irregular operation.
[0051] In this embodiment, an arm portion is formed on the inner second member, and a groove portion for receiving the arm portion is formed on the outer first member. However, an arm portion can also be formed on the outer first member, and a groove portion can also be formed on the inner second member. However, having the movable arm portion on the inner second member is preferable because it reduces the possibility of irregular operation by the operator. Also, forming the arm portion on the outer surface of the inner second member is easier to mold than forming it on the inner surface of the first member. Furthermore, the transfer operation is an operation to move the first member 111 and the second member 112 relative to each other, but from the operator's perspective, it is an operation to move the member on which the arm portion, which is the operation unit, is provided toward the other member. In this case, having the arm portion on the second member 112 attached to the vial, and having the operator recognize that this is the arm portion to be moved, is generally easier to operate and intuitively understand, preventing erroneous operation and is preferable.
[0052] Furthermore, in this embodiment, the maximum inner diameter of the first member 111 is larger than the maximum outer diameter of the second member 112, and the second member 112 is accommodated within the cylindrical first member 111. In this case, the operator can easily grasp and operate the first member 111 and the second member 112 during the transfer operation. By grasping and operating the first member 111, unlike when grasping and operating the transfer unit 106, a large force is not applied to the connection portion connecting the transfer unit 106 and the first member 111, making it less likely that the connection portion will be damaged. However, if a structure for grasping is provided in the first member 111, or depending on the shapes of the transfer unit 106 and the connection portion, the first member 111 attached to the transfer unit 106 can also be accommodated within the second member 112.
[0053] The transfer needle 137 can be electrically connected to the sealed vial 105 and can introduce or remove liquid from the vial 105. In this embodiment, the transfer needle 137 is molded integrally with the top plate 135 and the side wall 136, but these can also be molded separately and assembled later. In this embodiment, the connector portion 139 is a female luer connector that can be connected to a male luer connector with a lock nut of the transfer portion 106, and has a threaded portion 139a on the outside. However, the connector portion 139 is not limited to this configuration and can be selected from various configurations that can be connected to the connection portion on the transfer portion 106 side. Furthermore, the connector portion 139 is not limited to a configuration that can be separated from the connection portion on the transfer portion 106 side, but can also be configured to be glued or welded to the connection portion on the transfer portion 106 side.
[0054] In this embodiment, the vial fixing portion that fixes the second member 112 to the vial 105 is configured such that the ring-shaped portion 144 of the second member 112 fits over the narrowed neck of the vial 105, and the vial fixing claw 145 abuts against the lip of the vial from the base end. This configuration allows for easy fixing to the vial 105 to which the stopper 161 is already attached. However, once the vial fixing portion is fixed to the vial 105, it is difficult to remove it, making it easy to prevent the vial 105 from becoming detached or removed. Furthermore, since the vial 105 can be rotated relative to the second member 112, it is possible to prevent coring, which would otherwise occur when the needle 138 pierces the stopper 163 and cause the stopper 163 to be scraped. However, other configurations may also be used for the vial fixing portion that fixes the second member 112 to the vial 105.
[0055] A gripping portion 148 is formed at the base end of the second arm portion 142. The gripping portion 148 is a plate that extends in a curved shape on both sides in the circumferential direction from the second arm portion 142, and when the second member 112 is fixed to the vial 105, the base end of the gripping portion 148 is located closer to the base end than the base end of the vial 105. Because the gripping portion 148 has a longer circumferential length and a larger area than the second arm portion 142, when connecting the second member 112 to the first member 111, pressing the gripping portion 148 facilitates the connecting operation. Furthermore, when the arm-side second protrusion 156 is gripped, the fingers also come into contact with and are supported by the gripping portion 148, which facilitates the transfer operation. From the standpoint of operability, it is preferable for gripping portion 148 to protrude toward the base end of vial 105, but the base end of gripping portion 148 may be aligned with the base end of vial 105, or the base end of gripping portion 148 may be located toward the tip end of vial 105.
[0056] The gripping portion 148 also functions as a protective portion that protects the vial 105. In the non-conductive state, most of the vial 105 is covered by the gripping portion 148, other parts of the second member 112, and the first member 111. This makes it less likely that the vial 105 will be damaged by hitting a hard object during transportation or storage.
[0057] From the viewpoint of protecting the vial 105, it is preferable to form the gripping portion 148 having a long circumferential length and a large area covering the vial 105. From the viewpoint of enhancing the protective effect of the vial 105, the proportion of the circumferential length of the portion where the gripping portion 148 is formed to the total circumferential length is preferably 50%, and more preferably 75%. The circumferential length of the portion where the gripping portion 148 is formed is the circumferential length of the widest portion of the gripping portion 148, and if multiple gripping portions 148 are formed, it is the total value of all the widths. However, even if a gripping portion 148 having a short circumferential length is formed, or even if no gripping portion 148 is formed and only the first arm portion 141 and the second arm portion 142 are present, the effect of acting as a cushion to protect the vial 105 can be obtained.
[0058] Whether or not the gripping portion 148 is formed, from the viewpoint of protecting the vial 105, when the second member 112 is fixed to the vial 105, the position of the base end of the second member 112 is preferably located closer to the base end than half of the axial length between the mouth (tip) and base end (bottom) of the vial 105. From the viewpoint of making the vial 105 less likely to be damaged, it is more preferable that the base end of the second member is located at or closer to the base end of the vial 105. Note that, since the second member 112 covers half or more of the axial length of the vial 105, it is also possible to obtain the effect of making it difficult to grip the second member 112 and the vial 105 separately and forcibly remove the vial 105 from the vial fixing claws 145 by twisting or tilting the vial 105 relative to the second member 112.
[0059] Although the separation prevention portion, the movement restriction portion, and the return prevention portion are formed by the arm portion and the groove portion that receives the arm portion in the example shown, the separation prevention portion, the movement restriction portion, and the return prevention portion may have other configurations. Fig. 9 shows a vial connection portion 101A according to a modified example. The vial connection portion 101A has a first member 111A and a second member 112A.
[0060] As shown in FIG. 10, the first member 111A of this modification has a transfer needle 137 that penetrates a top plate 135 and a side wall 136 that surrounds the transfer needle 137, and a protrusion 171 that functions as a first-member-side connecting portion is formed on the inner surface of the side wall 136. As shown in FIG. 11, the second member 112A has a cylindrical wall 191 that extends from a partially cutout C-ring-shaped ring portion 144 toward the base end, and a vial fixing claw 145 that protrudes from the ring portion 144 toward the tip end. In this modification, the cylindrical wall 191 is divided into two portions by slits 192A and 192B. The slit 192A is connected to the notch in the ring portion 144.
[0061] A connecting groove 180 that functions as a second member side connecting portion is formed on the outer surface of each cylindrical wall 191. The relative position of the protrusion 171 can be moved along the connecting groove 180. The protrusion 171 and the connecting groove 180 function as a connecting portion that connects the first member 111A and the second member 112A.
[0062] The connecting groove 180 has a first groove portion 181 extending axially toward the base end, a second groove portion 182 extending circumferentially from the base end of the first groove portion 181, a third groove portion 183 extending obliquely from the end of the second groove portion 182 toward the base end as it moves away from the first groove portion 181, and a fourth groove portion 184 extending circumferentially from the base end of the third groove portion 183 so as to move away from the first groove portion 181. The first groove portion 181 is formed from the tip position of the ring-shaped portion 144, and therefore the convex portion 171 can be guided into the connecting groove 180 from the tip of the first groove portion 181.
[0063] A first blocking portion 187 is formed between the first groove portion 181 and the second groove portion 182, a second blocking portion 188 is formed between the second groove portion 182 and the third groove portion 183, and a third blocking portion 189 is formed between the third groove portion 183 and the fourth groove portion 184.
[0064] As shown in Fig. 12, the first blocking portion 187 is a convex portion that has an inclined surface from the first groove portion 181 side toward the second groove portion 182 side and a vertical surface that stands approximately perpendicularly outward in the radial direction from the second groove portion 182 side toward the first groove portion 181 side. As shown in Fig. 13, the second blocking portion 188 is a convex portion that has an inclined surface from the second groove portion 182 side toward the third groove portion 183 side and a vertical surface that stands approximately perpendicularly outward in the radial direction from the third groove portion 183 side toward the second groove portion 182 side. As shown in Fig. 14, the third blocking portion 189 is a convex portion that has an inclined surface from the third groove portion 183 side toward the fourth groove portion 184 side and a vertical surface that stands approximately perpendicularly outward in the radial direction from the fourth groove portion 184 side toward the third groove portion 183 side. For this reason, the convex portion 171 can be easily moved from the first groove portion 181 to the second groove portion 182, from the second groove portion 182 to the third groove portion 183, and from the third groove portion 183 to the fourth groove portion 184. On the other hand, it is difficult to move the convex portion 171 from the second groove portion 182 to the first groove portion 181, from the third groove portion 183 to the second groove portion 182, or from the fourth groove portion 184 to the third groove portion 183.
[0065] As shown in FIGS. 15 to 18 , when second member 112A is inserted into the opening on the base end side of first member 111A with first groove 181 aligned with protrusion 171, protrusion 171 easily moves over first blocking portion 187 toward second groove 182, and first member 111A and second member 112A are connected. First blocking portion 187 prevents protrusion 171 from moving from second groove 182 toward first groove 181, and therefore functions as a separation blocking portion that prevents separation between first member 111A and second member 112A. Furthermore, when protrusion 171 moves over first blocking portion 187, a sense of resistance is imparted to the operator, thereby also functioning to make the operator aware that first member 111A and second member 112A are connected.
[0066] When second member 112A is rotated relative to first member 111A, convex portion 171 moves over second blocking portion 188 toward third groove portion 183. When second member 112A is further rotated, convex portion 171 moves relatively toward the base end along third groove portion 183. As a result, second member 112A moves toward the tip end relative to first member 111A, so that needle portion 138 punctures stopper 163 and transitions to a conductive state. Finally, convex portion 171 moves over third blocking portion 189 toward fourth groove portion 184.
[0067] Because second groove 182 extends in a circumferential direction substantially perpendicular to first groove 181, convex portion 171 does not move from second groove 182 to third groove 183 simply by applying an axial force. Therefore, a non-conductive state in which needle 138 is not pierced into stopper 163 is maintained. Therefore, second groove 182 functions as a transition limiting portion that limits the transition from the non-conductive state to the conductive state. On the other hand, when the direction of the force applied to second member 112A is intentionally switched from the axial direction to the rotational direction, convex portion 171 moves to third groove 183 and continues to move to fourth groove 184. The transition from the non-conductive state to the conductive state can be achieved simply by rotating in one direction, which reduces the likelihood of the operator making a mistake or taking time to do so, making it less likely that the operator will make an operational error. On the other hand, since a movement in which the second member 112A rotates relative to the first member 111A is unlikely to occur naturally, it is possible to prevent unintended transitions from occurring.
[0068] In this modification, second blocking portion 188 is formed between second groove portion 182 and third groove portion 183, and therefore resistance is generated when convex portion 171 moves from second groove portion 182 to third groove portion 183, making it even more difficult for convex portion 171 to move unintentionally from second groove portion 182 to third groove portion 183. Second blocking portion 188 may be formed as needed, and does not necessarily have to be formed. Note that second blocking portion 188 may have a lower maximum height than first blocking portion 187 to make it easier for convex portion 171 to climb over it.
[0069] Third blocking portion 189 functions as a return blocking portion that blocks convex portion 171 from moving from the fourth groove portion 184 side to the third groove portion 183 side and prevents the convex portion 171 from returning from the conductive state to the non-conductive state. In addition, third blocking portion 189 provides a sense of resistance to the operator when moving from the third groove portion 183 side to the fourth groove portion 184 side, thereby enabling the operator to recognize that the transition to the conductive state has been completed.
[0070] The vial connection part 101A of this modification is automatically brought into a non-conductive state when the second member 112A is connected to the first member 111A. Furthermore, the transition from the non-conductive state to the conductive state can be achieved simply by rotating the second member 112A relative to the first member 111A. The transition from the non-conductive state to the conductive state can be achieved by a one-way operation without any preparatory operation, which makes it less likely that the operator will make an operational error.
[0071] In this modification, the connecting grooves 180 are formed in two portions of the cylindrical wall 191 separated by the slits 192A and 192B. The radial thickness of the cylindrical wall 191 is thinner than the radial thickness of the ring-shaped portion 144. Therefore, the cylindrical wall 191 can bend radially inward when the protrusion 171 passes over each blocking portion, when passing through a portion where the groove direction changes, and when passing through the inclined third groove portion 183. This allows the protrusion 171 to move smoothly. Furthermore, the cylindrical wall 191 can bend radially outward when the vial 105 passes over the vial fixing claws 145. This facilitates assembling the vial 105 to the second member 112, improving assembly efficiency.
[0072] In this modified example, an inner rib 194 extending in the axial direction is formed on the inner surface of the cylindrical wall 191. By forming the inner rib 194, the strength of the second member 112A can be increased. In this modified example, the inner rib 194 is formed on the back surface of the first blocking portion 187 and the third blocking portion 189. This prevents the first blocking portion 187 and the third blocking portion 189 from being deformed too much, making it even more difficult for the protrusion 171 to go over in the opposite direction. However, a configuration in which the inner rib 194 is not formed is also possible.
[0073] In this modification, two sets of connecting portions, each combining a protrusion 171 and a connecting groove 180, are formed facing each other across the central axis. This stabilizes the connection between the first member 111A and the second member 112A, allowing the second member 112A to move stably and smoothly relative to the first member 111A. Furthermore, the rotation angle required to complete the transition from the non-conductive state to the conductive state can be set to approximately 90 degrees, preventing the operator from being confused by an operation angle that is too large or too small. However, the number of connecting portions may be one set, or three or more sets.
[0074] In this modification, recesses 193 are formed on the outer surface of cylindrical wall 191. Recesses 193 are formed in positions that are not covered by first member 111A in the non-conductive state. Recesses 193 are also formed in two portions of cylindrical wall 191 separated by slits 192A and 192B so as to face each other across the central axis. Therefore, when transitioning from the non-conductive state to the conductive state, the operator can be guided to grip the recesses 193.
[0075] By gripping the recess 193 with fingers, the cylindrical wall 191 can be bent radially inward. Therefore, by gripping and operating the recess 193, the transition from the non-conductive state to the conductive state can be made even smoother. Furthermore, when connecting the second member 112A to the first member 111A, this can also be easily done by gripping the recess 193. However, a configuration in which the recess 193 is not formed is also possible.
[0076] In the first member 111A of this modified example, an outer rib 172 extending in the axial direction is formed on the outer surface of the side wall 136. Forming the outer rib 172 can improve the strength of the first member 111A. Furthermore, in this modified example, the outer rib 172 is formed on the surface opposite the convex portion 171. This makes it less likely that the convex portion 171 will deform significantly and go over the blocking portion in the opposite direction. However, a configuration in which the outer rib 172 is not formed is also possible.
[0077] In this modified example, a convex portion 171 is formed on the inner surface of the outer first member 111A, and a connecting groove 180 that receives the convex portion 171 is formed on the outer surface of the inner second member 112A. Forming the connecting groove 180 on the outer surface makes it easier to mold each member. However, if the first member 111A and the second member 112A can move relative to each other, a configuration in which a groove is formed on the inner surface of the first member 111A and a convex portion is formed on the outer surface of the second member 112A can also be used.
[0078] In this embodiment, the maximum inner diameter of the first member 111A is larger than the maximum outer diameter of the second member 112A, and the second member 112A is accommodated within the cylindrical first member 111A. In this case, the operator can grasp the first member 111A and the second member 112A during the transfer operation. By grasping and operating the first member 111A, unlike when grasping and operating the transfer unit 106, a large force is not applied to the connection between the transfer unit 106 and the first member 111A, making it less likely that the connection will be damaged. However, depending on whether a gripping portion is formed on the first member 111A or the shape of the transfer unit 106 and the connection portion, the first member 111A attached to the transfer unit 106 can also be accommodated within the second member 112A.
[0079] In this modification, when second member 112A is fixed to vial 105, the base end of cylindrical wall 191 is located closer to the base end than the base end of vial 105. This allows the operator to be guided to grip and operate second member 112A when connecting second member 112A to first member 111A and when transitioning to a conductive state. By gripping and operating second member 112A, it is possible to avoid a situation in which a large force is applied to the portion that fixes second member 112A to vial 105 compared to when vial 105 is gripped.
[0080] Furthermore, almost the entire vial 105 is covered with second member 112A, and it is possible to protect vial 105. However, in a state in which second member 112A is fixed to vial 150, the base end of cylindrical wall 191 may coincide with the base end of vial 105, or may be located closer to the tip end than the base end of vial 105. When second member 112A is expected to function as a cushion to protect vial 105, it is preferable that the position of the base end of second member 112A is located beyond the midpoint between the tip (mouth) and base end (bottom) of vial 105 toward the base end.
[0081] In order to protect the vial 105 and make it less susceptible to breakage, it is preferable that the cylindrical wall 191 cover as much of the vial 105 as possible in the circumferential direction, and the proportion of the circumferential length of the portion where the cylindrical wall 191 is formed to the total circumferential length is preferably 50% or more, more preferably 75% or more.
[0082] In this modification, the vial fixing portion that fixes the second member 112A to the vial can also employ various configurations, similar to the embodiment.
[0083] The connecting portion described in the embodiment and modified example has a separation prevention portion, so that once connected, the first and second members do not normally separate. It also has a transfer restriction portion, so that unintended transfer to a conductive state in which the transfer needle is inserted into the vial is unlikely to occur. Therefore, the vial can be stably maintained in a connected but non-conductive state in the transfer portion, making it easy to configure a drug transfer kit with the vial attached to a predetermined position in the transfer portion.
[0084] The kit also has a return prevention section, which prevents the kit from returning from a conductive state to a non-conductive state under normal circumstances. This makes it less likely that the kit will be accidentally returned to a non-conductive state during drug infusion and post-infusion processing, or that a used kit will be left in a non-conductive state and mistakenly recognized as unused.
[0085] For example, in the case of mixing and emulsifying an aqueous vaccine formulation with an oil-based adjuvant, water for injection is added from a first syringe to a vial of the vaccine formulation to dissolve the vaccine formulation, and the dissolved vaccine formulation is transferred to the first syringe. The adjuvant is transferred directly from the vial of the adjuvant to a second syringe. The vaccine formulation and adjuvant are then mixed while passing through an emulsifying filter. In this case, to form a W / O emulsion, the emulsifying filter must be hydrophobic so that the vaccine formulation passes through the emulsifying filter first. As such, the vaccine formulation and the adjuvant must be processed according to different, predetermined procedures, and therefore a specific vial must be connected to the connection port of the transfer unit.
[0086] A drug infusion kit in which a vial is connected to the infusion unit in a non-conductive state beforehand prevents the operator from connecting the vial incorrectly, even when the correct specific vial must be connected to the infusion unit's connection port. A drug infusion kit using the connection part of the present disclosure is useful not only when the infusion unit is a drug emulsification device, but also in drug infusion devices that have multiple vial connection parts and have a predetermined connection position for each vial. While vials are inexpensive and common containers, their shape is not distinctive, making them prone to mishandling when multiple vials are used. A drug infusion kit using the connection part of the present disclosure can prevent vial mishandling. Furthermore, when only one vial is connected to the infusion unit, the connection position is not incorrect, but the connection of the incorrect vial can be prevented, making a drug infusion kit with the connection part of the present disclosure useful. The items to be infused that can be connected to the infusion unit include various instruments such as syringes, vials, and bags.
[0087] When connecting multiple vials to the transfer unit, all vial connection units can have the same configuration, or vial connection units with different configurations can be combined. If all vial connection units are the same, the operator only needs to perform one operation, which improves operability and reduces the likelihood of operational errors. [Industrial Applicability]
[0088] The drug transfer kit of this invention is less prone to vial handling errors, is highly reliable, and is useful in the medical field, etc. [Explanation of symbols]
[0089] 100 Drug Transfer Kits 101 Vial connection 101A Vial Connection 105 vials 106 Transfer Section 107 Packaging materials 111 First Component 111A First member 112 Second member 112A Second member 131 First connecting groove 132 Second connecting groove 133 First member side connection part 134 Ribs 135 Top Plate 136 Side wall 137 Transfer needle 138 Needle 139 Connector part 139a Threaded part 141 First arm 142 Second arm 143 Second member side connection part 144 Ring-shaped part 145 Vial fixing claw 148 Gripping part 151 Groove side first convex part 152 Second convex part on groove side 152 Groove second convex part 155 First protrusion on arm side 156 Second protrusion on arm side 157 Third protrusion on arm side 161 Ventilated filter 163 Plug body 171 Convex part 172 outer rib 180 Connection groove 181 First groove 182 Second groove 183 Third Groove 184 4th groove 187 1st blocking part 188 2nd blocking part 189 Third blocking part 191 Cylinder wall 192A Slit 193 Recess 194 Inner rib
Claims
1. a transfer section having a plurality of vials in which drugs are sealed and a plurality of connection ports to which the corresponding specific vials are connected, and through which the drugs are transferred; and a plurality of vial connection sections connecting the transfer section and the vials; the vial connecting portion has a first member having a needle to be pierced into the stopper of the vial and connected to the transfer portion, and a second member having a vial fixing portion fixed to the vial and connected to the first member by a connecting portion; the connecting portion has a separation preventing portion that prevents the first member and the second member from being disconnected, a transition limiting portion that limits transition from a non-conductive state in which the needle and the vial are not conductive to a conductive state in which the needle and the vial are conductive, and a return preventing portion that prevents return from the conductive state to the non-conductive state, the second member is fitted into the first member, A drug infusion kit in which the second member fixed to the vial and the first member connected to the infusion portion in at least one of the vial connection portions are packaged in a connected state while maintaining the non-conductive state.
2. The drug transfer kit according to claim 1 , wherein the second member has a gripping portion that protrudes axially outward beyond the bottom surface of the vial.
3. the connecting portion has an axially extending elastically deformable arm portion provided on one of the first member and the second member, and an axially extending groove portion provided on the other member to receive the arm portion, the separation prevention portion, the transition restriction portion, and the return prevention portion each have an arm-side protrusion formed on the arm portion and a groove-side protrusion formed on the groove portion, the separation prevention portion and the return prevention portion are configured so that the arm-side protrusion portion can get over the groove-side protrusion portion in a direction in which the needle and the vial approach each other, but prevent the arm-side protrusion portion from getting over the groove-side protrusion portion in the opposite direction; The drug transfer kit of claim 1 or 2, wherein the transition restriction portion is configured so that, when grasped, the arm-side protrusion portion can overcome the groove-side convex portion in the direction in which the needle and the vial approach each other.
4. the connecting portion has a plurality of the arm portions, The drug transfer kit according to claim 3 , wherein the migration restricting portion is formed on an arm portion different from the arm portions that constitute the separation preventing portion and the return preventing portion.
5. the connecting portion has a convex portion provided on one of the first member and the second member, and a groove portion provided on the other member that receives the convex portion, The groove portion includes a first groove portion extending in the axial direction, a second groove portion extending in the circumferential direction from one end of the first groove portion, a third groove portion extending in an oblique direction from an end of the second groove portion opposite to the first groove portion, and a fourth groove portion extending in the circumferential direction from an end of the third groove portion opposite to the second groove portion, a first blocking portion is provided between the first groove portion and the second groove portion, the first blocking portion being configured to allow the convex portion to move from the first groove portion side to the second groove portion side but preventing the convex portion from moving in the opposite direction; a second blocking portion is provided between the third groove portion and the fourth groove portion, the second blocking portion being configured to allow the convex portion to move over from the third groove portion side to the fourth groove portion side but to prevent the convex portion from moving over in the opposite direction; the separation prevention portion is constituted by the first prevention portion, the transition limiting portion is constituted by the second groove portion, The drug transfer kit according to claim 1 or 2, wherein the return prevention portion is constituted by the second prevention portion.
6. The groove portion is formed on the outer surface of the cylindrical wall of the second member, The drug transfer kit according to claim 5 , wherein the cylindrical wall has a slit and is capable of bending radially inward.
7. a vial in which a drug is sealed, a transfer section into which the drug is transferred, and a vial connection section that connects the transfer section and the vial; the vial connecting portion has a first member having a needle to be pierced into the stopper of the vial and connected to the transfer portion, and a second member having a vial fixing portion fixed to the vial and connected to the first member by a connecting portion; the connecting portion has a separation preventing portion that prevents the first member and the second member from being disconnected, and a transition limiting portion that limits a transition from a non-conductive state in which the needle and the vial are not conductive to a conductive state in which the needle and the vial are conductive, the second member is fitted into the first member, when the second member is fixed to the vial, an end of the second member opposite to the first member is located at a position beyond the middle position between the mouth and the bottom of the vial toward the bottom, A drug infusion kit in which the second member fixed to the vial and the first member connected to the infusion portion in the vial connection portion are packaged in a connected state while maintaining the non-conductive state.
Citation Information
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