JP2018038592A - Vial adapter - Google Patents

Abstract

PROBLEM TO BE SOLVED: To mount a device such as a closed system device or a vial shield to plural types of vials different in size.SOLUTION: A vial adapter 1 comprises: a hook 27 configured to engage with an enlarged diameter part 85 surrounding an opening 83 of a body 81 of a vial 80; and an adjacent part 24a configured to be adjacent to the outer peripheral surface 85c of the enlarged diameter part 85. The adjacent part 24a can be deviated elastically so as to be spaced from the central axis 1a of the vial adapter 1.SELECTED DRAWING: Figure 1A

Description

  The present invention relates to a vial adapter used by being attached to a vial.

  When administering a powdered drug contained in a vial to a patient, first, a solution is injected into the vial to dissolve the drug to obtain a drug, and then the drug is transferred from the vial to a drug bag. The preparation of the chemical solution to be transferred is performed.

  In some cases, the drug contained in the vial is a dangerous drug designated as a powerful drug, such as an anticancer drug. In this case, in order to prevent the drug, its chemical solution, or its vapor (hereinafter referred to as “medicine etc.”) from leaking to the outside and exposing the worker, the drug etc. leaks to the outside in the preparation of the chemical. Less likely “closed devices” are used.

  An example of such a closed system device is described in Patent Documents 1 and 2. The devices of Patent Documents 1 and 2 (referred to as “connectors” in Patent Documents 1 and 2) switch between three connectors to which a vial, a drug solution bag, and a syringe are connected, and the flow paths in the device. With a cook. The drug solution bag initially stores a solution for dissolving the drug. By operating the cock and switching the flow path appropriately and operating the syringe, the solution in the drug solution bag is transferred to the vial through the syringe, the drug in the vial is dissolved to obtain the drug solution, and then The chemical solution in the vial can be transferred to the chemical solution bag via the syringe. Once the vial, drug solution bag, and syringe are connected to the device, the drug solution prepared in the drug solution bag can be obtained without separating them from the device. Sex is generally low.

  The mouth (opening) of the vial is sealed with a stopper (rubber stopper). The connector connected to the vial of the device includes a puncture needle (sometimes referred to as a “bottle needle”) that is pierced into the stopper of the vial. Even when the above device is used, when the puncture needle is punctured into the stopper (ie, when the device is connected to the vial), or when the puncture needle is subsequently pulled out from the stopper (ie, the device is separated from the vial) When the puncture needle punctures the plug, the medicine or the like may leak out.

  In order to prevent this, Patent Document 3 describes a vial shield attached to a vial. The vial shield includes a thin plate-like valve body made of an elastic material such as rubber. The vial shield is attached to the vial so that the valve body overlaps the top of the vial stopper. Subsequently, the device is mounted on the vial. The puncture needle of the device punctures the valve body of the vial shield and the stopper body of the vial bottle in order. Even if a drug or the like leaks from the hole through which the puncture needle has pierced the plug body, the drug or the like is trapped between the plug body and the valve body, so that the possibility of leaking to the outside world is low.

International Publication No. 2013/161979 Pamphlet International Publication No. 2015/166993 Pamphlet International Publication No. 2014/104027 Pamphlet Japanese Patent Laid-Open No. 2006-054805

  The vial is provided with a diameter-enlarged portion enlarging in a flange shape surrounding the mouth. Each of the devices and vial shields includes a claw that engages the enlarged diameter portion. Engaging the respective claws of the device and vial shield with the enlarged diameter portion prevents the device and vial shield from being unintentionally separated from the vial.

  There are various sizes of vials. For example, a plurality of standards such as φ13, φ15, and φ20 exist for the outer diameter of the enlarged diameter portion. For example, if the device and the vial shield configured to fit a φ20 vial are attached to a vial having a smaller-diameter enlarged portion, the claw cannot be firmly engaged with the enlarged-diameter portion. As a result, the device and vial shield will rattle. For this reason, for example, when the puncture needle is tilted with respect to the plug body, the drug or the like leaks to the outside through a gap formed between the inner surface of the hole through which the puncture needle punctures the plug body and the puncture needle, The vial body of the vial shield is separated from the stopper and the medicine leaks out between the valve body and the stopper body, or the medicine or the like is unintentionally separated from the vial by the device or the vial shield. There is a possibility of leaking to the outside world.

  Preparing devices such as devices and vial shields for each vial size leads to an increase in the number of types of the devices, for example, medical institutions such as hospitals need to keep all types of devices in stock. Therefore, management becomes complicated.

  An object of the present invention is to make it possible to attach a device such as a closed system device or a vial shield to a plurality of types of vials having different sizes.

  The vial adapter of the present invention is attached to a vial bottle in which the mouth of the bottle body is sealed with a stopper. The vial adapter includes a claw configured to be engaged with an enlarged diameter portion surrounding the mouth, and an abutting portion configured to be in contact with an outer peripheral surface of the expanded diameter portion. The contact portion can be elastically displaced so as to be separated from the central axis of the vial adapter.

  The vial adapter of the present invention includes a contact portion that can be elastically displaced so as to be separated from the central axis. Since the abutment portion is appropriately elastically displaced according to the difference in the outer diameter of the enlarged diameter portion, the range of the outer diameter of the enlarged diameter portion where the vial adapter can be mounted without rattling is relatively wide. A closed system device adapted to the vial adapter (second vial) having an enlarged diameter portion having an outer diameter larger than that of the vial bottle (first vial bottle) to which the vial adapter is attached. If the vial adapter is configured so that a device such as a vial shield can be attached, the device can be attached to the first vial without rattling through the vial adapter. As described above, according to the present invention, it is possible to attach a device such as a closed system device or a vial shield to a vial having a size different from that of a vial to which the device is originally adapted.

FIG. 1A is a perspective view of a vial adapter according to an embodiment of the present invention as viewed from above. FIG. 1B is a perspective view of the vial adapter according to the embodiment of the present invention as seen from below. FIG. 1C is a side view of a vial adapter according to an embodiment of the present invention. FIG. 1D is a front view of a vial adapter according to an embodiment of the present invention. FIG. 1E is a plan view of a vial adapter according to an embodiment of the present invention. FIG. 1F is a cross-sectional perspective view of the vial adapter according to the embodiment of the present invention cut along a plane including the central axis as seen from above. FIG. 1G is a cross-sectional perspective view of the vial adapter according to one embodiment of the present invention cut along a plane including the central axis as seen from below. FIG. 1H is a cross-sectional perspective view of the vial adapter according to the embodiment of the present invention cut along another plane including the central axis as seen from above. FIG. 2 is an exploded perspective view showing a method of using the vial adapter according to the embodiment of the present invention. FIG. 3A is a perspective view of a vial bottle to which a vial adapter according to an embodiment of the present invention is attached. FIG. 3B is a cross-sectional view of the vial. FIG. 4 is a perspective view of a vial shield attached to a vial adapter according to an embodiment of the present invention. FIG. 5A is a cross-sectional perspective view of the vial shield attached to the vial adapter according to the embodiment of the present invention as seen from above. FIG. 5B is a cross-sectional perspective view of the vial shield attached to the vial adapter according to the embodiment of the present invention as seen from below. FIG. 6 is a cross-sectional perspective view of the second connector of the device attached to the vial adapter according to the embodiment of the present invention. FIG. 7A is a perspective view showing a state in which the vial adapter according to one embodiment of the present invention is attached to a vial having a diameter-expanding portion of φ13. FIG. 7B is a cross-sectional view showing a state where the vial adapter according to the embodiment of the present invention is attached to a vial having a diameter-expanding portion of φ13. FIG. 7C is a cross-sectional perspective view showing a state in which the vial adapter according to the embodiment of the present invention is attached to a vial having a diameter-expanding portion of φ13. FIG. 8A is a perspective view showing a state in which the vial adapter according to one embodiment of the present invention is attached to a vial having a diameter-enlarged portion of φ15. FIG. 8B is a cross-sectional view showing a state in which the vial adapter according to the embodiment of the present invention is attached to a vial having a diameter-expanding portion of φ15. FIG. 8C is a cross-sectional perspective view showing a state in which the vial adapter according to the embodiment of the present invention is attached to a vial having a diameter-expanding portion of φ15. FIG. 9A is a perspective view showing a state where a vial adapter and a vial shield according to an embodiment of the present invention are attached to a vial having a diameter-expanded portion of φ13. FIG. 9B is a cross-sectional view showing a state where a vial adapter and a vial shield according to an embodiment of the present invention are attached to a vial having a diameter-expanded portion of φ13. FIG. 9C is another cross-sectional view showing a state in which the vial adapter and the vial shield according to the embodiment of the present invention are attached to the vial having the diameter-expanded portion of φ13. FIG. 10 is a perspective view showing a state in which a vial adapter, a vial shield, and a closed system device according to an embodiment of the present invention are mounted on a vial having an enlarged diameter portion of φ13. FIG. 11 is an enlarged cross-sectional perspective view showing an elastic piece and its peripheral part of a vial adapter according to another embodiment of the present invention mounted on a vial.

  The vial adapter according to the present invention connects the contact portion and the base end portion so that the contact portion, the base end portion, and the contact portion and the base end portion are separated from each other and face each other. You may further provide the elastic piece provided with the bending part. The elastic piece may be cantilevered at the base end. The contact portion may be provided at a terminal portion of the elastic piece. In this case, when the contact portion is elastically displaced so as to be separated from the central axis, the base end portion is elastically bent and deformed so that the bent portion is separated from the central axis, and The contact portion and the bent portion may be elastically bent and deformed so that the contact portion approaches the base end portion. According to such a configuration, the contact portion is provided at the end portion of the elastic piece having a relatively long region that can be elastically deformed. This is advantageous in reducing the rigidity of the elastic piece related to displacing the contact portion away from the central axis. Therefore, the force required when mounting the vial adapter on the vial can be reduced.

  The tip of the claw may be elastically displaceable so as to be separated from the central axis of the vial adapter. According to such a configuration, the claw is elastically displaced appropriately according to the difference in the outer diameter of the neck portion, so that the vial adapter can be positioned with respect to a plurality of types of vials having different outer diameters of the neck portion.

  When the tip of the claw is displaced away from the central axis, it may be displaced downward at the same time. According to such a configuration, the vial adapter can be attached to the vial bottle with almost no change in the vertical position of the vial adapter with respect to the upper surface of the stopper regardless of the difference in dimensions of the enlarged diameter portion. Therefore, when the vial shield is attached to the vial through the vial adapter, the adhesion of the valve body to the upper surface of the stopper can be secured, and the device is attached to the vial through the vial adapter. In this case, the puncture needle can be punctured into the plug body at a desired depth.

  The contact portion may be provided with an engaging portion that protrudes toward the central axis so as to engage with the enlarged diameter portion on the side opposite to the neck portion. Since the engaging portion prevents the vial adapter from moving downward relative to the enlarged diameter portion, it is advantageous in facilitating the operation of mounting a device such as a vial shield or a device on the vial adapter.

  The vial to which the vial adapter is attached may be a first vial. The vial adapter can be attached to a second vial having an enlarged diameter portion having an outer diameter larger than the enlarged diameter portion of the first vial bottle, and is associated with the enlarged diameter portion of the second vial bottle. It may be configured such that a device having a claw configured to fit can be attached to the vial adapter. In this case, the vial adapter may include an engagement mechanism that engages with the device when the device is mounted on the vial adapter. According to this configuration, the device configured to fit the second vial can be attached to the first vial without rattling through the vial adapter.

  The vial adapter is configured such that the claw of the device does not engage with the enlarged diameter portion of the first vial when the device is attached to the vial adapter attached to the first vial. May be. Such a configuration is advantageous for attaching the device to the first vial without rattling.

  The engagement mechanism may be configured to engage with the claw of the device when the device is attached to the vial adapter. Such a configuration may be advantageous to simplify the configuration of the vial adapter.

  The vial adapter of the present invention may further include a base configured to protrude outward in the radial direction from the device when the device is mounted on the vial adapter. Such a configuration is advantageous for easily performing the operation of attaching and detaching the device to and from the vial adapter.

  The device may be a vial shield including a valve body and a shield body that holds the valve body. In this case, the vial adapter may be configured such that when the vial shield is attached to the vial adapter attached to the first vial, the valve body is overlaid on the upper surface of the stopper. According to such a configuration, the valve body of the vial shield can be reliably stacked on the upper surface of the stopper of the first vial without being separated. This is advantageous in reducing the risk of exposure of the worker to the drug when a dangerous drug is contained in the first vial.

  The device may be a device provided with a puncture needle. In this case, the vial adapter may be configured such that the puncture needle punctures the stopper when the device is attached to the vial adapter attached to the first vial. According to this configuration, the puncture needle of the device can be punctured without tilting the stopper of the first vial. This is advantageous in reducing the risk of exposure of the worker to the drug when a dangerous drug is contained in the first vial.

  Below, this invention is demonstrated in detail, showing suitable embodiment. However, it goes without saying that the present invention is not limited to the following embodiments. Each drawing referred to in the following description shows simplified main members constituting an embodiment of the present invention for convenience of description. Therefore, the present invention can include any member not shown in the following drawings. Further, within the scope of the present invention, each member shown in the following drawings can be changed or omitted. In the drawings showing the embodiments of the present invention, the same or corresponding members are denoted by the same reference numerals, and redundant description of such members is omitted.

1. Configuration of Vial Adapter FIG. 1A is a perspective view seen from above the vial adapter 1 according to one embodiment of the present invention, and FIG. 1B is a perspective view seen from below the vial adapter 1. 1C is a side view of the vial adapter 1, FIG. 1D is a front view of the vial adapter 1, and FIG. 1E is a plan view of the vial adapter 1. For convenience of the following explanation, an XYZ orthogonal coordinate system as shown is set. The Z axis is parallel to the central axis 1a of the vial adapter 1 (see FIG. 1E). The Z-axis direction is referred to as “vertical direction”, the plane orthogonal to the Z-axis (XY plane) is referred to as “horizontal plane”, and the direction parallel to the horizontal plane is referred to as “horizontal direction”. In the vertical direction, the side on which the Z-axis arrow is directed is called “upper side”, and the opposite side is called “lower side”. However, “up and down direction”, “horizontal direction”, “upper side”, and “lower side” do not mean directions when the vial adapter 1 is used. The vertical dimension is called “height”. The direction rotating around the central axis 1a is referred to as “circumferential direction”, and the direction orthogonal to the central axis 1a is referred to as “radial direction”. In the radial direction, the side closer to the central axis 1a is referred to as "inner side" and the side farther from the central axis 1a is referred to as "outer side". The central axis 1a is also the central axis of the vials 80, 80′80 ″ to which the vial adapter 1 is attached, the vial shield 200 and the device 300 (see FIG. 2 described later) attached to the vial adapter 1.

  As shown in FIGS. 1A and 1B, the vial adapter 1 includes an annular base 10 provided with a circular opening in the center. The base 10 is a thin plate extending along a horizontal plane. A tapered surface 14 protrudes upward from an inner edge that forms the opening of the base 10. The taper surface 14 is a conical surface that is coaxial with the central axis 1a and whose outer diameter decreases toward the top (see FIG. 1D). Two first rods 11 and four second rods 12 extend upward in parallel with the Z axis from the upper end edge of the tapered surface 14. The two first rods 11 face each other in the Y-axis direction. Two second rods 12 are arranged between the first rods 11 adjacent in the circumferential direction. Each second rod 12 is spaced apart in the circumferential direction from both the first rod 11 and the second rod 12 adjacent in the circumferential direction. The heights of the two first rods 11 and the four second rods 12 from the base 10 are substantially the same. As shown in FIG. 1E, the outer surfaces of the first rod 11 and the second rod 12 (surfaces opposite to the central axis 1a) are substantially along a common cylindrical surface coaxial with the central axis 1a. The first rod 11 and the second rod 12 are sequentially connected in the circumferential direction via first and second side walls 21 and 22 (details will be described later). And these rods 11 and 12 and the side walls 21 and 22 comprise the cylindrical part which has a hollow substantially cylindrical shape as a whole.

  FIG. 1F is a cross-sectional perspective view of the cut vial adapter 1 taken along the XZ plane including the central axis 1a, and FIG. 1G shows the cut vial adapter 1 taken along the XZ plane including the central axis 1a. It is the section perspective view seen from the lower part. FIG. 1H is a cross-sectional perspective view of the cut vial adapter 1 as viewed from above along another plane (including the 1H-1H line in FIG. 1E) including the central axis 1a.

  As shown in FIGS. 1A, 1C, 1G, and 1H, the first rod 11 and the second rod 12 that are adjacent to each other in the circumferential direction are connected to each other via the first side wall 21 and the bridge 25. .

  The first side wall 21 connects the upper end of the first rod 11 and its vicinity and the upper end of the second rod 12 and its vicinity in the circumferential direction. The first side wall 21 is substantially along a cylindrical surface coaxial with the central axis 1a. The outer surface of the first side wall 21 (the surface opposite to the central axis 1 a) is set back toward the central axis 1 a from the outer surfaces of the first rod 11 and the second rod 12. As shown in FIG. 1H, an elastic piece 24 is provided at the lower end edge of the first side wall 21. The elastic piece 24 is a bent portion that connects the base end portion 24c extending downward from the lower end edge of the first side wall 21, the contact portion 24a that is the end portion of the elastic piece 24, and the base end portion 24c and the contact portion 24a. Part 24b. The contact portion 24a extends in the vertical direction, and is disposed on the inner side in the radial direction with respect to the first side wall 21 and the base end portion 24c. The contact portion 24a is spaced apart from and opposed to the first side wall 21 and / or the base end portion 24c in the radial direction. The cross-sectional shape of the elastic piece 24 along the surface including the central axis 1a is a substantially “U” shape or a substantially “V” shape. The elastic piece 24 is elastically deformed so that when a radially outward force is applied to the contact portion 24a, the contact portion 24a is displaced radially outward (in a direction away from the central axis 1a). Is possible.

  The bridge 25 bridges the first rod 11 and the second rod 12 below the first side wall 21 (base 10 side). The bridge 25 extends along the circumferential direction. Preferably, the lower edge of the bridge 25 is the same as or slightly lower than the bent portion 24b which is the lower end of the elastic piece 24. Further, the bridge 25 is preferably arranged on the outer side in the radial direction from the elastic piece 24 so that the elastic piece 24 does not collide with the bridge 25 even if the elastic piece 24 is elastically deformed as described above. Unlike the elastic piece 24, the bridge 25 has a rigidity that does not substantially deform due to an external force.

  The first rod 11 and the second rod 12, adjacent to each other in the circumferential direction, the bridge 25, and the tapered surface 14 constitute a substantially rectangular first opening 16 (see FIG. 1C).

  Since the two second rods 12 are provided between the first rods 11 adjacent to each other in the circumferential direction, the vial adapter 1 includes four elastic pieces 24 and four bridges 25 as a whole.

  As shown in FIG. 1A, FIG. 1D, and FIG. 1H, the upper ends of the second rods 12 adjacent in the circumferential direction and the vicinity thereof are connected via the second side wall 22. The second side wall 22 is substantially along a cylindrical surface coaxial with the central axis 1a. The outer surface of the second side wall 22 (the surface on the side opposite to the central axis 1a) is set back from the outer surface of the second rod 12 toward the central axis 1a. Slits (cuts) 22a extending upward from the lower end of the second side wall 22 are formed at both ends in the circumferential direction of the second side wall 22 (boundary portions of the second side wall 22 with the second rod 12). (See FIG. 1D). For this reason, the second side wall 22 is connected to the second rod 12 only at the upper end and the vicinity thereof in the entire length portion in the vertical direction. As shown in FIGS. 1F and 1H, a claw 27 protruding inward is provided at the lower end edge of the second side wall 22 or in the vicinity thereof.

  The tip of the claw 27 (the part of the claw 27 closest to the central axis 1a) 27a is along an arc concentric with the central axis 1a (see FIG. 1E). As shown in FIG. 1G, an inclined surface 27b is provided on the lower side of the tip 27a so as to be separated from the central axis 1a as the distance from the tip 27a increases. The inclined surface 27 b is provided on a substantially wedge-shaped rib 27 c extending downward from both circumferential edges of the claw 27. The inclined surface 27b is preferably a smooth convex curved surface projecting inward (or downward).

  As best shown in FIGS. 1F and 1H, the tip 27a of the claw 27 is located below (the base 10 side) the contact portion 24a of the elastic piece 24. As shown in FIG. 1E, the tip 27a of the claw 27 is closer to the central axis 1a than the contact portion 24a of the elastic piece 24. The two claws 27 are opposed to each other in the X axis direction.

  The second side wall 22 (particularly, the portion of the second side wall 22 sandwiched between the pair of slits 22a) is such that the tip 27a of the claw 27 is displaced outward in the radial direction (direction away from the central axis 1a). It can be bent and deformed elastically.

  As shown in FIG. 1A, a third side wall 23 extending upward from the base 10 is provided between the second rods 12 adjacent in the circumferential direction. An engagement protrusion 28 that protrudes outward in the radial direction is provided on the upper end edge of the third side wall 23. As shown in FIGS. 1C and 1F, the engagement protrusion 28 includes an inclined surface 28b on the upper side of a tip 28a (a portion of the engagement protrusion 28 that protrudes most outward in the radial direction) 28a. . The inclined surface 28b is inclined so as to move away from the central axis 1a as it goes downward. As shown in FIG. 1D, the engagement protrusion 28 is separated from the lower end edge of the second side wall 22 in the vertical direction. As shown in FIG. 1E, the engagement protrusion 28 is located on the radially outer side than the first rod 11 and the second rod 12. Two engaging protrusions 28 protrude in opposite directions along the X-axis direction.

  The two ribs 27c extending downward from the claw 27, the second side wall 22, and the third side wall 23 (or the engaging projection 28) constitute a substantially rectangular second opening 17 (see FIG. 1D). .

  As shown in FIG. 1A, an inclined surface 26 is provided at the upper end of the first rod 11. The inclined surface 26 is inclined so as to approach the central axis 1a as it goes upward.

  The vial adapter 1 is rotationally symmetrical twice with respect to the central axis 1a (when rotated 180 degrees, it overlaps with the state before rotation).

  The vial adapter 1 is preferably made of a hard material. Specifically, resin materials such as polypropylene, polyacetal, acrylonitrile-butadiene-styrene copolymer (ABS), polycarbonate, polystyrene, polyamide, and hard polyvinyl chloride can be used. The vial adapter 1 can be integrally formed as one part using such a resin material by an injection molding method or the like.

2. Usage Method of Vial Adapter FIG. 2 is an exploded perspective view showing a usage method of the vial adapter 1. As described above, there are multiple sizes of vials. The vial bottles 80, 80 ′, 80 ″ are provided with enlarged diameter portions 85, 85 ′, 85 ″ having outer diameters of φ13, φ15, φ20 in this order.

  The vial shield 200 and the closed system device (hereinafter simply referred to as “device”) 300 are designed to fit into a vial 80 ″ with an enlarged diameter portion of φ20. The shield 200 and the device 300 can be sequentially attached. The vial adapter 1 is not attached to the vial bottle 80 ″.

  The vial shield 200 and the device 300 are attached to the vial bottles 80 and 80 ′ having the diameter-expanded portions 85 and 85 ′ having a diameter smaller than the diameter-expanded portion 85 ″ of the vial bottle 80 ″ and φ13 and φ15. I can't.

  On the other hand, the vial adapter 1 can be attached to the vials 80 and 80 '. A vial shield 200 and a device 300 can be sequentially attached to the vial adapter 1. Therefore, the vial shield 200 and the device 300 can be attached to the vial bottles 80 and 80 ′ by interposing the vial adapter 1.

  The vials 80, 80 ', 80 ", the vial shield 200, and the device 300 will be described below.

2.1. Vial Bottle FIG. 3A is a perspective view of a vial bottle 80 having an enlarged diameter portion 85 of φ13, and FIG. 3B is a cross-sectional view of the vial bottle 80. The vial 80 is a sealed container in which a stopper (rubber stopper) 86 is fitted into a mouth (opening) 83 that opens upward from the bottle body 81 to seal the mouth 83 in an airtight and liquid tight manner. The bottle body 81 is made of a hard material that does not substantially deform such as glass. A powdered medicine (not shown) is accommodated in the vial 80. A flange 82 is provided at the upper end of the bottle body 81 so as to surround the mouth 83. The outer peripheral surface of the flange 82 is a substantially cylindrical surface having an outer diameter larger than that of the neck portion (constriction portion) 84 adjacent to the lower side of the flange 82. Therefore, a step is formed between the flange 82 and the neck portion 84 based on the difference between the outer diameters of the two. The plug 86 has the same maximum outer diameter as the flange 82.

  In order to prevent the stopper 86 from falling off from the mouth 83 of the bottle body 81, a cap 88 is attached to the stopper 86 and the flange 82. The cap 88 is made of a sheet of metal (for example, aluminum) or resin, and is in close contact with the plug 86 and the flange 82. The lower end of the cap 88 extends to the lower side of the outer peripheral surface which is a substantially cylindrical surface of the flange 82. The upper end of the cap 88 extends to the upper surface of the plug 86. A central region on the upper surface of the plug 86 is exposed to the outside through a circular opening 88 a provided in the cap 88.

  A portion that is covered with the cap 88 and has a diameter relatively larger than that of the neck portion 84 is referred to as an enlarged diameter portion 85. The outer peripheral surface 85c of the enlarged diameter portion 85 is a substantially cylindrical surface. The upper end of the outer peripheral surface 85c of the enlarged diameter portion 85 is referred to as an upper end edge 85b, and the lower end of the outer peripheral surface 85c is referred to as a lower end edge 85d.

  The vial 80 may not have the cap 88. In that case, the diameter-expanded portion 85 refers to a portion that is larger in diameter than the flange 82 and the neck portion 84 of the plug body 86, and the upper edge 85 b, outer peripheral surface 85 c, and lower edge 85 d are the plug body 86 or the flange 82. Means the corresponding part of

  The configuration of the vials 80 ′ and 80 ″ having the diameter-expanded portions of φ15 and φ20 is substantially the same as that of the vial 80 shown in FIGS. 3A and 3B, and a detailed description thereof will be omitted. In order to distinguish the vials 80, 80 ′, 80 ″ in the description, the symbols attached to the corresponding parts of the vial 80 are denoted by “′” and “ Each with “” is used. The parts labeled with “′” and “” ”are the parts of the vial 80 ′ and the vial 80 ″, respectively, and the vials with the signs excluding“ ′ ”and“ ”” are attached. This corresponds to 80 parts. Therefore, for the parts to which the reference numerals including “′” and “” ”are attached, the description and drawings relating to the corresponding parts of the vial 80 should be taken into consideration as appropriate. For example, “a diameter-expanded portion 85 ″” means a diameter-expanded portion of a φ20 vial 80 ″, and the configuration of the diameter-expanded portion 85 of the φ13 vial 80 shown in FIGS. 3A and 3B is described. Unless otherwise noted, it applies.

2.2. Vial Shield FIG. 4 is a perspective view of the vial shield 200. 5A is a cross-sectional perspective view of the vial shield 200 as viewed from above, and FIG. 5B is a cross-sectional perspective view of the vial shield 200 as viewed from below. The vial shield 200 is substantially the same as the vial shield described in “Embodiment 2” of Patent Document 3 (see FIGS. 14A to 20 of Patent Document 3).

  The vial shield 200 includes a shield body 210 and a valve body 220.

  The shield body 210 includes an annular top plate 211 having a circular opening 212 formed in the center. Two pairs of horizontal portions (bridge portions) 219 extend radially from the outer peripheral edge of the top plate 211. A side plate 213 extends downward from an outer end (an end opposite to the top plate 211) of each pair of horizontal portions 219. The side wall 213 forms a cylindrical surface that is coaxial with the opening 212. The pair of side walls 213 are connected at the lower ends thereof via an annular portion 217 coaxial with the opening 212. As shown in FIG. 5B, the inner peripheral surface of the annular portion 217 is provided with a tapered surface 218 whose outer diameter decreases toward the top.

  A substantially “U” -shaped slit (cut) 214 is formed in the side wall 213. Thereby, an elastic piece (leg) 215 surrounded by the slit 214 is formed in the side wall 213. The elastic piece 215 has a cantilever support structure in which the upper end is a fixed end and the lower end is a free end. A claw 216 protrudes inward from the lower end (free end) of the elastic piece 215. The elastic piece 215 can be elastically bent and deformed so that the claw 216 is displaced outward in the radial direction.

  As shown in FIG. 5B, the claw 216 is inclined to the lower side of the tip (the part that protrudes inwardly among the claws 216) 216 a toward the outer side in the radial direction as the distance from the tip 216 a increases. An inclined surface 216b is provided.

  The shield body 210 is made of a hard material, and for example, a resin material such as polyethylene, polypropylene, polycarbonate, styrene ethylene, polyethylene terephthalate, polybutylene terephthalate, and butylene styrene block copolymer can be used.

  The valve body 220 is a thin plate-like body having a circular plan view shape. The valve body 220 is made of a rubber-like elastic material that deforms when an external force is applied, and immediately returns to the initial shape when the external force is removed. Specifically, rubbers such as natural rubber, isoprene rubber, and silicone rubber, and thermoplastic elastomers such as styrene elastomer, olefin elastomer, and polyurethane elastomer can be used.

  As shown in FIG. 5B, a central protrusion 224 that protrudes downward is provided in the central region of the lower surface of the valve body 220. In the central region 224, a notch 222 that penetrates the valve body 220 in the thickness direction (vertical direction) is formed. The notch 222 has a straight plan view shape and intersects the central axis (not shown) of the vial shield 200.

  The valve body 220 is integrated with the top plate 211 from the lower side thereof so as to close the opening 212 of the top plate 211 of the shield body 210.

  As described above, the vial shield 200 is designed to be compatible with a φ20 vial 80 ″ (see FIG. 2). The method for attaching the vial shield 200 to the vial 80 ″ is described in “Implementation of Patent Document 3”. This is substantially the same as the vial shield described in “Mode 2” (see FIGS. 14A to 20 of Patent Document 3). That is, the enlarged diameter portion 85 ″ of the vial 80 ″ is inserted into the annular portion 217 of the vial shield 200. The claw 216 is fitted into the neck portion 84 ″ and engaged with the enlarged diameter portion 85 ″. The valve body 220 is overlaid on the upper surface of the plug body 86 ″. The central protrusion 224 protruding from the lower surface of the valve body 220 is in close contact with the upper surface of the plug body 86 ″ exposed in the opening 88a ″ of the cap 88 ″. The puncture needle is inserted into the notch 222 of the valve body 220, and further pierces the plug body 86 ". Even if the liquid medicine leaks from the hole through which the puncture needle has pierced the plug body 86", the liquid medicine or the like is plugged. 86 ″ and the valve body 220 are confined and held. Accordingly, it is possible to prevent the chemical liquid and the like from leaking to the outside.

2.3. Closed system device
The device 300 in FIG. 2 is used for preparing a drug solution by dissolving a powdered drug contained in vials 80, 80 ′, and 80 ″ similarly to the devices of Patent Documents 1 and 2. Reference numeral 300 denotes a first connector 301 connected to a chemical solution bag (not shown), a second connector 302 connected to vials 80, 80 ′, and 80 ″, and a first connector connected to a syringe (not shown). 3 connector 303 and a rotatable cock 305 for switching the flow path in the device 300. The solution stored in the drug solution bag is transferred to the vials 80, 80 ', 80 "to dissolve the drug in the vials 80, 80', 80" to obtain a drug solution, and then the vials 80, 80 The chemical solution in “, 80” is transferred to the chemical solution bag. The dissolved solution and the chemical solution are transferred by operating the syringe while the cock 305 is rotated to form a predetermined flow path in the device 300. .

  The configuration of the second connector 302 in FIG. 2 is substantially the same as the connector described in Patent Document 2. FIG. 6 is a cross-sectional perspective view of a second connector (hereinafter simply referred to as “connector”) 302 constituting the device 300. The connector 302 includes a connector main body 310, a slider 350, and a cover 390. The connector body 310 includes a puncture needle 320 that can puncture the stoppers 86, 86 ', 86 "of the vials 80, 80', 80". In the initial state shown in FIG. 6, the openings of the two flow paths 321 and 322 provided in the puncture needle 320 are covered with a cover 390 and sealed. Cover 390 is held by slider 350.

  The cover 390 is made of a material (so-called elastomer) that has flexibility (softness), deforms when an external force is applied, and returns to an initial shape as soon as the external force is removed (so-called elastomer). A slit 395 that penetrates the cover 390 in the vertical direction is formed at the tip of the cover 390.

  The slider 350 includes four claws 366 (only two claws 366 are shown in FIG. 6) protruding toward the puncture needle 320. The claw 366 is provided at the lower end (that is, the free end) of the grip arm 365 having a cantilever support structure. The gripping arm 365 can be elastically bent and deformed so that the claw 366 moves away from the puncture needle 320. The claw 366 includes an inclined surface 366b on the lower side of its tip (the part of the claw 366 closest to the puncture needle 320) 366a. The inclined surface 366b is inclined so as to approach the puncture needle 320 as it goes upward.

  The slider 350 further includes two contact protrusions 364. The contact protrusion 364 is provided at the upper end (that is, the free end) of the slide restricting arm 362 of the cantilever support structure. The slide restricting arm 362 can be elastically bent and deformed so that the contact protrusion 364 is separated from the puncture needle 320.

  Each of the connector main body 310 and the slider 350 has a hollow, generally cylindrical shape as a whole. The slider 350 is movable along the longitudinal direction of the puncture needle 320 so as to be inserted into and removed from the connector main body 310. FIG. 6 shows the connector 302 in an initial state in which the slider 350 is pulled out from the connector main body 310. Although details are omitted, the slider 350 is restricted from being inserted into the connector main body 310 in the initial state. This restriction is released when the contact protrusion 364 is displaced away from the puncture needle 320.

  As described above, the connector 302 of the device 300 is designed to be compatible with a φ20 vial 80 ″ (see FIG. 2). Is substantially the same as the following. The enlarged diameter portion 85 ″ of the vial 80 ″ is inserted into the slider 350 of the connector 302 (FIG. 6) in the initial state. The claw 366 of the slider 350 is fitted into the neck portion 84 ″ of the vial bottle 80 ″ and engages with the enlarged diameter portion 85 ″. The abutment protrusion 364 abuts against the upper edge 85b ″ of the enlarged diameter portion 85 ″. The claw 366 and the contact protrusion 364 of the 350 hold the enlarged diameter portion 85 ″ of the vial 80 ″. The contact protrusion 364 contacts the upper end edge 85b ″ of the expanded diameter portion 85 ″ to thereby puncture the needle. It is displaced away from 320. As a result, the above-described restriction is released, and the slider 350 can be inserted into the connector main body 310.

  The slider 350 holding the vial 80 ″ is inserted into the connector main body 310. The puncture needle 320 passes through the cover 390 and further passes through the plug body 86 ″ of the vial 80 ″. The slider 350 is the connector main body. It is inserted into the deepest in 310.

  The connector 302 can also be attached to the vial 80 ″ equipped with the vial shield 200. The enlarged diameter portion 85 ″ exposed when the vial shield 200 is attached to the vial 80 ″ is attached to the connector 302. The claw 366 engages and the abutment protrusion 364 abuts.The inner diameter of the slider 350 is set to be larger than the cylindrical surface formed by the outer surface of the side wall 213 of the vial shield 200. Therefore, the vial shield 200 is attached. Similarly to the case where the connector 300 is attached to the non-vial vial 80 ″, the connector 302 can be connected to the vial 80 ″ equipped with the vial shield 200 without the connector 302 colliding with the vial shield 200. .

2.4. Attachment of the vial adapter to the vial bottle The attachment of the vial adapter 1 to the vial bottle 80 having the φ13 enlarged diameter portion 85 is performed as follows.

  As shown in FIG. 2, the enlarged diameter portion 85 of the vial 80 is inserted into the opening provided in the base 10 of the vial adapter 1. The inclined surface 27b (see FIGS. 1B and 1G) of the claw 27 of the vial adapter 1 collides with the upper end edge 85b (see FIGS. 3A and 3B) of the enlarged diameter portion 85. Due to the downward pressing force applied to the vial adapter 1, the second side wall 22 is elastically bent and deformed so that the tip 27a of the claw 27 is separated from the central axis 1a. The tip 27 a of the claw 27 slides on the outer peripheral surface 85 c of the enlarged diameter portion 85. And if the front-end | tip 27a of the nail | claw 27 exceeds the lower end edge 85d of the outer peripheral surface 85c, the 2nd side wall 22 will elastically recover and the nail | claw 27 will fit in the neck part 84. FIG.

  The attachment of the vial adapter 1 to the vial bottle 80 'having the φ15 enlarged diameter portion 85' is substantially the same as described above.

  FIG. 7A is a perspective view showing a state in which the vial adapter 1 is attached to the vial 80 having the diameter-expanded portion 85 of φ13. FIG. 8A is a perspective view showing a state in which the vial adapter 1 is attached to a vial bottle 80 ′ having a φ15 diameter-expanded portion 85 ′. The upper surfaces of the stoppers 86 and 86 ′ are exposed in a cylindrical portion surrounded by the first and second rods 11 and 12 and the first and second side walls 21 and 22 of the vial adapter 1.

  7B is a cross-sectional view of FIG. 7A, and FIG. 8B is a cross-sectional view of FIG. 8A. 7B and 8B are parallel to the XZ plane. A pair of claws 27 facing in the X-axis direction are fitted into the neck portions 84 and 84 'and engaged with the enlarged diameter portions 85 and 85'. For this reason, the vial bottles 80 and 80 ′ cannot be pulled out from the vial adapter 1.

  As can be seen by comparing FIG. 8B with FIG. 7B, the second side wall 22 provided with the claw 27 is bent and deformed more greatly in FIG. 8B than in FIG. 7B. In general, the outer diameters of the neck portions 84 and 84 'differ depending on the outer diameters of the enlarged diameter portions 85 and 85'. Since the second side wall 22 is deformed according to the outer diameters of the neck portions 84 and 84 ′, the tip 27a (see FIGS. 1F and 1H) of the claw 27 is brought into contact with both the neck portions 84 and 84 ′. be able to. The pair of claws 27 sandwich the neck portions 84 and 84 ′ having different outer diameters in the X-axis direction. Therefore, the vial adapter 1 is positioned in the X-axis direction with respect to the vials 80 and 80 '. The arc provided at the tip 27a of the claw 27 is advantageous for reducing the inclination of the vial adapter 1 with respect to the vials 80 and 80 '.

  As shown in FIGS. 1F and 1H, the claw 27 is provided at or near the lower end of the second side wall 22 and extends from the second side wall 22 almost along the radial direction toward the central axis 1a. . For this reason, when the tip 27a of the claw 27 is displaced outward in the radial direction, the tip 27a is also displaced slightly downward at the same time. In general, in addition to the outer diameter of the neck portions 84 and 84 ′, the vertical dimension of the enlarged diameter portions 85 and 85 ′ varies depending on the outer diameter of the enlarged diameter portions 85 and 85 ′. For this reason, when the vial adapter 1 is attached to a vial bottle 80 ′ having a larger diameter-expanded portion 85 ′ (see FIG. 8B), the tip 27a of the claw 27 is greatly displaced outward in the radial direction, and also downward. Displace more greatly. Therefore, irrespective of the difference in the dimensions of the enlarged diameter portions 85 and 85 ′, the relative position in the vertical direction of the vial adapter 1 with respect to the upper surfaces of the stoppers 86 and 86 ′ is made almost the same, It can be attached to 80 '.

  7C is a cross-sectional perspective view of FIG. 7A, and FIG. 8C is a cross-sectional perspective view of FIG. 8A. The cross section of FIG. 7C and FIG. 8C is the same as that of FIG. 1H, and passes through the opposing elastic piece 24 of the vial adapter 1. The contact portion 24a (see FIG. 1H) of the elastic piece 24 is in contact with the outer peripheral surfaces 85c and 85c 'of the enlarged diameter portions 85 and 85'. The elastic piece 24 is pushed by the outer peripheral surfaces 85c and 85c 'and is elastically deformed so that the contact portion 24a is displaced outward in the radial direction. In addition to the pair of claws 27 facing in the X-axis direction sandwiching the neck portions 84 and 84 'in the X-axis direction (see FIGS. 7B and 8B), four elastic pieces arranged in a distributed manner in the circumferential direction When 24 contacts the outer peripheral surfaces 85c and 85c ′ of the enlarged diameter portions 85 and 85 ′, the vial adapter 1 is arranged coaxially with respect to the vial bottles 80 and 80 ′.

  As can be seen by comparing FIG. 8C with FIG. 7C, the elastic piece 24 is bent and deformed more greatly in FIG. 8C than in FIG. 7C. That is, the elastic piece 24 is deformed according to the outer diameter of the outer peripheral surfaces 85c and 85c 'of the enlarged diameter portions 85 and 85'. Therefore, the vial adapter 1 can be stably mounted on the vial bottles 80 and 80 ′ having the enlarged diameter portions 85 and 85 ′ having different outer diameters without being loosely coaxial.

  As described with reference to FIG. 1H, the elastic piece 24 includes the contact portion 24a and the base end portion 24b via the bent portion 24b so that the contact portion 24a and the base end portion 24b are spaced apart from each other in the radial direction. And have a substantially “U” shape or a substantially “V” shape. The elastic piece 24 has a shape obtained by bending a thin strip-like thin plate so as to have a substantially “U” shape or a substantially “V” shape. The elastic piece 24 has a cantilever support structure in which the upper end of the base end portion 24 b is connected to the lower end edge of the first side wall 21, and a contact portion 24 a is provided at the terminal end of the elastic piece 24. Therefore, as can be easily understood from FIG. 8C, when the contact portion 24a is pushed outward in the radial direction, the base end portion 24c is elastically bent so that the bent portion 24b is displaced outward in the radial direction. While being deformed, the contact portion 24a and the bent portion 24b are elastically bent and deformed so that the contact portion 24a approaches the base end portion 24c (or the first side wall 21). The length along the elastic piece 24 from the lower end edge of the first side wall 21 to the contact portion 24a is long, and almost the entire long elastic piece 24 is elastically bent and deformed. Since the elastically deforming region is long, it is possible to reduce the rigidity of the elastic piece 24 related to displacing the contact portion 24a outward in the radial direction. This is to reduce the downward pressing force of the vial adapter 1 against the vial 80 ′, which is necessary when the vial adapter 1 is attached to the vial 80 ′ having the enlarged diameter portion 85 ′ having a large outer diameter. It is advantageous.

2.5. Attaching the vial shield A vial shield 200 (see FIGS. 4, 5A and 5B) is attached to the vials 80 and 80 ′ (see FIGS. 7A to 7C and FIGS. 8A to 8C) to which the vial adapter 1 is attached. The

  The direction in which the pair of second side walls 22 (see FIGS. 7A and 8A) of the vial adapter 1 are opposed to the direction in which the pair of claws 216 (see FIGS. 5A and 5B) of the vial shield 200 are opposed to each other. The vial shield 200 is aligned around the central axis 1a with respect to the vial adapter 1 (see FIG. 2). Then, the vial adapter 1 is inserted into the annular portion 217 of the vial shield 200. The inclined surface 216 b (see FIG. 5B) of the claw 216 of the vial shield 200 collides with the upper end edge of the second side wall 22 of the vial adapter 1. Due to the downward pressing force applied to the vial shield 200, the elastic piece 215 is elastically bent and deformed so that the claw 216 moves outward in the radial direction. The tip 216 a of the claw 216 slides on the second side wall 22. When the tip 216 a of the claw 216 exceeds the lower end edge of the second side wall 22, the elastic piece 215 is elastically recovered and the claw 216 is fitted into the second opening 17.

  In parallel with this, the annular portion 217 of the vial shield 200 collides with the inclined surface 28b (see FIGS. 1A and 1C) of the engagement protrusion 28 of the vial adapter 1. Due to the downward pressing force applied to the vial shield 200, the annular portion 217 is elastically deformed so as to expand in the direction connecting the pair of engagement protrusions 28 (X-axis direction) while sliding on the inclined surface 28b. Is done. The annular portion 217 recovers elastically as soon as it gets over the engaging protrusion 28.

  FIG. 9A is a perspective view showing a state in which the vial adapter 1 and the vial shield 200 are attached to the vial 80 having the diameter-expanded portion 85 of φ13. 9B and 9C are cross-sectional views thereof. 9B is parallel to the XZ plane, and the cross section of FIG. 9C is parallel to the YZ plane.

  As shown in FIG. 9C, the tapered surface 218 (see FIG. 5B) provided on the annular portion 217 of the vial shield 200 is fitted to the tapered surface 14 of the vial adapter 1 (see FIGS. 1A and 1D). Yes. For this reason, the vial shield 200 is arranged coaxially with respect to the vial adapter 1 and further arranged coaxially with respect to the vial bottle 80. Further, the movement of the vial shield 200 downward with respect to the vial adapter 1 is restricted.

  As shown in FIG. 9B, the engagement protrusion 28 of the vial adapter 1 is positioned above the annular portion 217 of the vial shield 200, and both are engaged. Further, as described above, the claw 27 of the vial adapter 1 is engaged with the enlarged diameter portion 85 of the vial bottle 80. This restricts the vial shield 200 from moving upward relative to the vial 80.

  The valve body 220 of the vial shield 200 is superimposed on the upper surface of the stopper body 86 of the vial bottle 80. As described above, since the vial shield 200 cannot move upward with respect to the vial 80, the valve body 220 is pressed against and closely contacts the upper surface of the stopper body 86. In the present embodiment, the central protrusion 224 (see FIG. 5C) protruding from the lower surface of the valve body 220 is in close contact with the plug body 86 exposed in the opening 88a (see FIG. 3A) of the cap 88.

  As can be understood from FIG. 9A, the second side wall 22 of the vial adapter 1 and the second rods 12 (not visible in FIG. 9A) on both sides thereof are opposed to the side plate 213 and the elastic piece 215 of the vial shield 200 in the radial direction. . The first rod 11 of the vial adapter 1 and the first side wall 21 and the bridge 25 adjacent to the first rod 11 are exposed without being covered by the vial shield 200.

  Although not shown, the vial adapter 1 and the vial shield 200 can be mounted on the vial bottle 80 ′ having the φ15 diameter-expanded portion 85 ′ in the same manner as described above. When the vial adapter 1 is mounted on the φ15 vial 80 ′ (see FIG. 8B), the deformation amount of the second side wall 22 is larger than when the vial adapter 1 is mounted on the φ13 vial 80 (see FIG. 7B). The claw 27 is displaced more greatly. Even in such a case, as can be understood from FIG. 9B, the second side wall 22 and the claw 27 of the vial adapter 1 do not collide with the side plate 213, the elastic piece 215, and the claw 216 of the vial shield 200. .

  As described above, the vial shield 200 designed to fit the φ20 vial 80 ″ (see FIG. 2) is interposed between the vial adapter 1 and the φ13 vial 80 and the φ15 vial 80 ′. When the vial adapter 1 is used, the claw 216 of the vial shield 200 configured to engage with the enlarged diameter portion 85 ″ of the vial 80 ″ is used to expand the vials 80 and 80 ′. It does not engage with the diameter portions 85 and 85'.By fixing the annular portion 217 of the vial shield 200 to the vial adapter 1, the vial shield 200 is indirectly attached to the vial bottles 80 and 80 'via the vial adapter 1. It is firmly attached to.

2.6. Attaching a closed system device (device) A device 300 (see FIGS. 2 and 6) is attached to the vial bottles 80 and 80 ′ (see FIGS. 9A to 9C) to which the vial adapter 1 and the vial shield 200 are attached. A case where the device 300 is attached to the vial bottle 80 will be described.

  The vial adapter 1 is arranged so that the direction in which the pair of first rods 11 (see FIG. 9A) of the vial adapter 1 is opposed to the direction in which the pair of contact protrusions 364 (see FIG. 6) of the device 300 is opposed. On the other hand, the device 300 in the initial state is aligned around the central axis 1a (see FIG. 2). Then, the vial adapter 1 and the vial shield 200 are inserted into the slider 350 of the device 300.

  The inclined surface 366b (see FIG. 6) of the claw 366 of the slider 350 collides with the upper end edge of the first side wall 21 (see FIG. 9A) of the vial adapter 1. The downward pressing force applied to the device 300 causes the gripping arm 365 to bend and deform elastically so that the claw 366 moves away from the puncture needle 320. A tip 366 a of the claw 366 slides on the first side wall 21. Next, the inclined surface 366b of the claw 366 collides with the bridge 25 (see FIG. 9A), and the claw 366 rides on the bridge 25. When the claw 366 passes over the bridge 25, the gripping arm 365 is elastically recovered and the claw 366 is fitted into the first opening 16. At substantially the same time, the contact protrusion 364 of the slider 350 contacts the inclined surface 26 provided at the upper end of the first rod 11.

  The claw 366 of the slider 350 engages with the bridge 25 of the vial adapter 1, and the contact protrusion 364 of the slider 350 contacts the inclined surface 26 of the vial adapter 1, so that the slider 350 holds the vial adapter 1 firmly.

  When the contact protrusion 364 contacts the inclined surface 26 of the first rod 11, the slide restricting arm 362 is elastically bent and deformed, and the contact protrusion 364 is displaced away from the puncture needle 320. As a result, the slider 350 shifts to a state where it can be inserted into the connector main body 310. When the upper portion of the device 300 (for example, the first connector 301, see FIG. 2) is pushed toward the vial 80, the slider 350 is inserted into the connector main body 310. The puncture needle 320 provided in the connector main body 310 passes through the cover 390, passes through the notch 222 provided in the valve body 220 of the vial shield 200, and further punctures the plug body 86 of the vial 80. When the slider 350 is inserted most deeply into the connector main body 310, the flow paths 321 and 322 of the puncture needle 320 communicate with the vial 80, and the connection between the device 300 and the vial 80 is completed. FIG. 10 is a perspective view showing a state in which the vial adapter 1, the vial shield 200, and the device 300 are attached to the vial bottle 80.

  Although not described in detail, the device 300 (see FIGS. 2 and 6) can be mounted in the same manner as described above on a φ15 vial 80 ′ to which the vial adapter 1 and the vial shield 200 are mounted.

  As described above, the device 300 designed to fit the φ20 vial 80 ″ (see FIG. 2) can be inserted into the φ13 vial 80 and the φ15 vial 80 ′ by interposing the vial adapter 1. When the vial adapter 1 is used, the claw 366 of the device 300 configured to engage the enlarged diameter portion 85 ″ of the vial bottle 80 ″ is the enlarged diameter portion of the vial bottle 80, 80 ′. 85, 85 'does not engage, instead, it engages with the bridge 25 of the vial adapter 1. Also, it is configured to abut against the upper edge 85b "of the enlarged diameter portion 85" of the vial 80 ". The contact protrusion 364 of the device 300 does not contact the upper end edges 85b and 85b ′ of the vials 80 and 80 ′ but instead contacts the inclined surface 26 of the vial adapter 1. Accordingly, the device 300 is securely attached to the vial bottles 80 and 80 ′ indirectly through the vial adapter 1.

  A method for preparing a drug solution from a drug in the vials 80 and 80 ′ by using the device 300 is the same as in Patent Documents 1 and 2. After adjusting the drug solution, the device 300 is separated from the vial adapter 1. Separation of the device 300 and the vial adapter 1 can be performed in the same manner as the separation of the device 300 and the φ20 vial bottle 80 ″. This is substantially the same as the method for separating from the bottle. The vials 80 and 80 ′ from which the device 300 has been separated are discarded with the vial adapter 1 and the vial shield 200 attached.

3. As described above, the vial adapter 1 includes the claw 27 that fits into the neck portion of the vial and engages the enlarged diameter portion, and the contact portion 24a that abuts the outer peripheral surface of the enlarged diameter portion of the vial bottle. . The contact portion 24a can be elastically displaced so as to be separated from the central axis 1a. For this reason, the contact part 24a is appropriately elastically displaced according to the difference in the outer diameter of the enlarged diameter part. A slight difference in the outer diameter of the enlarged diameter portion is absorbed by the elastic displacement of the contact portion 24a. Therefore, the range of the outer diameter of the enlarged diameter portion where the vial adapter 1 can be mounted without rattling is relatively wide. For example, as in the above-described embodiment, the vial adapter 1 can be configured so that it can be mounted on two types of vial bottles 80 and 80 ′ having different outer diameters without rattling. If the vial adapter 1 is configured so that the vial shield 200 and / or the device 300 can be attached to the vial adapter 1, the vial shield 200 and / or the device 300 can be connected to the vials 80, 80 ′ via the vial adapter 1. Can be worn without rattling.

  The vial shield 200 and the device 300 are attached to a vial 80 ″ having an enlarged diameter portion 85 ″ having an outer diameter larger than the enlarged diameter portions 85, 85 ′ of the vial bottles 80, 80 ′ to which the vial adapter 1 is attached. It may be designed to. By using the vial adapter 1, a device such as the vial shield 200 or the device 300 is different from the vial 80 ″ in addition to the vial 80 ″ to which the device is inherently compatible (more accurately). Can also be attached to vials 80, 80 '(smaller than vial 80 "), thus eliminating the need to prepare equipment such as vial shield 200 and device 300 for each vial size. Therefore, the number of types of devices can be reduced, and the management of the devices can be simplified.If the vial adapter 1 can be attached to the plurality of size vials 80 and 80 'without rattling, the vial shield 200 or The number of vials that can be equipped with equipment such as device 300 is further increased.

  When the tip 27a of the claw 27 of the vial adapter 1 is elastically displaced outward in the radial direction, it is also displaced downward at the same time. For this reason, even if the vial adapter 1 is attached to the vial bottles 80 and 80 ′ having the enlarged diameter portions 85 and 85 ′ having different sizes, the relative position in the vertical direction of the vial adapter 1 with respect to the upper surfaces of the stoppers 86 and 86 ′ is It will be almost the same. Therefore, when the vial shield 200 is attached to the vials 80 and 80 ′ having different sizes via the vial adapter 1, the adhesiveness of the valve body 220 to the upper surfaces of the stoppers 86 and 86 ′ is set to the vials 80 and 80 ′. When the device 300 is attached to the vial bottles 80 and 80 ′ having different sizes via the vial adapter 1, the puncture depth of the puncture needle 320 with respect to the plugs 86 and 86 ′ is substantially the same. The thickness can be made substantially the same between the vials 80 and 80 '.

  The vial adapter 1 includes a base 10 that protrudes radially outward. The base 10 is advantageous for facilitating the work of attaching the vial shield 200 to the vial adapter 1 and the work of attaching / detaching the device 300 to / from the vial adapter 1. Preferably, when the vial shield 200 is attached to the vial adapter 1, the base 10 protrudes outward in the radial direction from the vial shield 200 (particularly, the annular portion 217) (see FIGS. 7A and 8A). Thereby, the operation | work which attaches the device 300 to the vial adapter 1 after that can be hold | gripped with the base 10. FIG. Preferably, when the device 300 is mounted on the vial adapter 1, the base 10 protrudes outward in the radial direction from the device 300 (particularly, the connector main body 310 and the slider 350) (see FIG. 10). Thereby, after that, the operation | work which isolate | separates the device 300 from the vial adapter 1 can be performed by holding the base 10.

  The vial shield 200 and device 300 include a claw 216 and a claw 366 configured to engage the enlarged diameter portion 85 "of the vial 80". When the vial shield 200 and the device 300 are attached to the vial bottles 80 and 80 ′ via the vial adapter 1, the claw 216 and the claw 366 are engaged with the enlarged diameter portions 85 and 85 ′ of the vial bottles 80 and 80 ′. do not do. This is advantageous for attaching the vial shield 200 and device 300 to the vials 80, 80 'without rattling.

  The vial adapter 1 includes a shield engagement mechanism (engagement protrusion 28) and a device engagement mechanism (bridge 25) for engaging and fixing the vial shield 200 and the device 300. This is advantageous for mounting the vial shield 200 and the device 300 to the vials 80 and 80 ′ through the vial adapter 1 without rattling.

  In the present invention, there is no restriction as to which part of the vial shield 200 and device 300 the shield engagement mechanism and device engagement mechanism engage. However, like the device engagement mechanism (bridge 25) of the above-mentioned embodiment, the engagement mechanism is engaged with the claw 366 of the device 300 configured to engage with the enlarged diameter portion 85 ″ of the vial 80 ″. Matching may be advantageous in simplifying the configuration of the vial adapter 1.

4). Various modifications The above embodiment is merely an example. The present invention is not limited to the above embodiment, and can be modified as appropriate.

  In the above embodiment, the vial shield 200 and the device 300 are mounted on three types of vials 80, 80 ′, and 80 ″ having different sizes of φ13, φ15, and φ20. However, the size of the vial is merely an example. The present invention can also be applied to vials of any size other than these.

  In the above embodiment, the vial adapter 1 can be attached to the vials 80 and 80 ′ having two sizes of φ13 and φ15. However, the number of vials to which the vial adapter of the present invention can be attached is as follows. The number is not limited to two, and may be one or three or more. Even if the vial adapter can only be attached to one size vial, the vial adapter can be used to bring the vial shield 200 and device 300 configured to fit larger size vials. It becomes possible to attach to a small-sized vial.

  In the above embodiment, the vial adapter 1, the vial shield 200, and the device 300 are sequentially attached to the vial bottles 80 and 80 ', but the present invention is not limited to this. For example, the device 300 may be attached to the vial adapter 1 without using the vial shield 200. After the vial shield 200 is attached to the vial adapter 1, these may be attached to the vial bottles 80 and 80 '.

  The configuration of the vial adapter of the present invention is not limited to the vial adapter 1 shown in the above embodiment, and can be changed as appropriate. For example, the number and arrangement of the elastic pieces 24 and the claws 27 including the contact portion 24a are not limited to the above-described embodiment, and are arbitrary. However, in order to arrange the vial adapter 1 coaxially without rattling with respect to the enlarged diameter portions 85, 85 ′ of the vials 80, 80 ′, a plurality of elastic pieces 24 (including the contact portions 24a) and It is preferable that the plurality of claws 27 are discretely arranged in the circumferential direction. The shield engagement mechanism may have a configuration other than the engagement protrusion 28, and the device engagement mechanism may have a configuration other than the bridge 25.

  As shown in FIG. 11, an engaging portion 24d that protrudes inward in the radial direction may be provided at the upper end of the contact portion 24a. The engaging portion 24 d is configured to engage with the upper end edge 85 b of the outer peripheral surface 85 c of the enlarged diameter portion 85 or the upper surface of the enlarged diameter portion 85. The engaging portion 24d prevents the vial adapter 1 from moving downward with respect to the enlarged diameter portion 85 when the vial adapter 1 is attached to the vial bottle 80. Since the engaging portion 24d and the claw 27 grip the enlarged diameter portion 85 in the vertical direction, the movement of the vial adapter 1 in the vertical direction with respect to the enlarged diameter portion 85 is limited. This is advantageous for facilitating the subsequent operation of mounting the vial shield 200 and / or the device 300 on the vial adapter 1. Although not shown, the engaging portion 24d can similarly engage with the engaging portion 85 'of φ15.

  The vial adapter of the present invention may include a valve body corresponding to the valve body 220 of the vial shield 200. For example, you may provide the valve body 220 and the top plate 211 (refer FIG. 4) holding this on the upper end of the 1st rod 11 and / or the 2nd rod 12 through the member similar to the horizontal part 219. FIG. In this case, it is not necessary to attach the vial shield 200 to the vial adapter. Moreover, the shield engaging mechanism (engagement protrusion 28) and the taper surface 14 for fixing the vial shield 200 can be omitted.

  The configuration of the vial shield and the closed system device attached to the vial adapter of the present invention is not limited to the vial shield 200 and the device 300 described above. For example, the vial shield is a vial shield described in Embodiment 1 of Patent Document 3, a vial shield described in Patent Document 4 (referred to as “container cover” in Patent Document 4), or other than these. Any vial shield may be used. Further, the closed system device may be a device described in Patent Document 1 (referred to as “container connector” in Patent Document 1) or any other device connected to a vial. . Depending on the configuration of the vial shield and the closed system device, the configuration of the vial adapter of the present invention, such as the shield engagement mechanism and the device engagement mechanism, can be changed as appropriate.

  In addition, the vial adapter of the present invention may be configured to be able to be attached to any device configured to be attached to a vial, other than the vial shield and the closed system device. According to the present invention, a device configured to fit a specific size vial can be attached to a small size vial via the vial adapter of the present invention. Has the same effect as.

  The field of application of the present invention can be widely used in the field of handling vials. Among them, it can be preferably used in the medical field, particularly in the field of preparing a drug solution to be administered to a patient in infusion. Although there is no restriction | limiting in the kind of chemical | medical agent accommodated in the vial bottle, It is preferable that it is a chemical | medical agent which a chemical | medical agent exposure of workers, such as an anticancer agent, becomes a problem.

DESCRIPTION OF SYMBOLS 1 Vial adapter 1a Center axis | shaft 24 Elastic piece 24a Contact part 24b Bending part 24c Base end part 24d Engagement part 25 Bridge (device engagement mechanism)
27 Claw 27a Claw tip 28 Engagement projection (shield engagement mechanism)
80, 80 ', 80 "vial body 81, 81', 81" bottle body 83, 83 ', 83 "bottle body port 84, 84', 84" neck portion 85, 85 ', 85 "expanded diameter portion 85c, 85c ', 85c "Peripheral surface 200 of enlarged diameter portion Vial shield 210 Shield body 216 Nail 220 of vial shield Valve body 300 Device 320 Puncture needle 366 Device nail

Claims (11)

A vial adapter attached to a vial with the mouth of the bottle body sealed with a stopper,
A claw configured to engage an enlarged diameter portion surrounding the mouth;
A contact portion configured to contact the outer peripheral surface of the diameter-expanded portion,
The vial adapter is characterized in that the contact portion can be elastically displaced so as to be separated from a central axis of the vial adapter. An elastic piece comprising: the abutting portion; a base end portion; and a bent portion connecting the abutting portion and the base end portion so that the abutting portion and the base end portion are spaced apart from each other and face each other. In addition,
The elastic piece is cantilevered at the base end,
The contact portion is provided at the end of the elastic piece;
When the abutment portion is elastically displaced so as to be separated from the central axis, the base end portion is elastically bent and deformed so that the bent portion is separated from the central axis, and the abutment portion The vial adapter according to claim 1, wherein the abutting portion and the bent portion are elastically bent and deformed so as to approach the base end portion.   The vial adapter according to claim 1 or 2, wherein a tip of the claw can be elastically displaced so as to be separated from a central axis of the vial adapter.   The vial adapter according to claim 3, wherein when the tip of the claw is displaced away from the central axis, the tip is also displaced downward.   The engagement part which protruded toward the said central axis so that the said contact part may engage with the said enlarged diameter part on the opposite side to the said nail | claw is provided. The vial adapter described in. The vial to which the vial adapter is attached is a first vial;
The vial adapter can be attached to a second vial having an enlarged diameter portion having an outer diameter larger than the enlarged diameter portion of the first vial bottle, and is associated with the enlarged diameter portion of the second vial bottle. It is configured so that a device with a claw configured to fit can be attached to the vial adapter,
The said vial adapter is a vial adapter as described in any one of Claims 1-5 provided with the engaging mechanism engaged with the said apparatus when the said apparatus is mounted | worn with the said vial adapter.   The vial adapter is configured such that the claw of the device does not engage with the enlarged diameter portion of the first vial when the device is attached to the vial adapter attached to the first vial. The vial adapter according to claim 6.   The vial adapter according to claim 6 or 7, wherein the engagement mechanism is configured to engage with the claw of the device when the device is mounted on the vial adapter.   The vial adapter according to any one of claims 6 to 8, further comprising a base configured to protrude radially outward from the device when the device is mounted on the vial adapter. The device is a vial shield including a valve body and a shield body that holds the valve body,
The said vial adapter is comprised so that the said valve body may be piled up on the upper surface of the said stopper, when the said vial shield is mounted | worn with the said vial adapter mounted | worn with the said 1st vial bottle. The vial adapter according to claim 1. The device is a device equipped with a puncture needle,
The said vial adapter is comprised so that the said puncture needle may puncture the said stopper, when the said device is mounted | worn with the said vial adapter mounted to the said 1st vial bottle. The vial adapter described in.

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