JP2023118849A - vial adapter - Google Patents

Abstract

To improve safety by reducing the possibility that medicine gas in a vial leaks out to the outside in work for taking chemical liquid in the vial out of the vial.SOLUTION: A vial adapter 1 includes a puncture needle 20 and a female connector 50. A liquid flow passage 24 and a gas flow passage 25 are provided in the puncture needle. The liquid flow passage is communicated with the female connector, and the gas flow passage is connected with a vent hole 46. A unidirectional valve 40 for allowing gas to flow from the vent hole to the gas flow passage and to inhibit the gas from flowing on the contrary is provided on a gas communication path for making the gas flow passage communicate with the vent hole. The gas communication path includes a narrow path 35b having a cross sectional area smaller than the gas flow passage between the gas flow passage and the unidirectional valve.SELECTED DRAWING: Figure 3

Description

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a vial adapter used when taking out a drug solution from a vial.

When infusing the drug solution in the sealed vial into a patient, it is necessary to transfer the drug solution from the vial to the drug solution bag and prepare the drug solution in the drug solution bag. Transfer of the drug solution is generally performed by aspirating the drug solution from the vial into a syringe and then injecting the drug solution from the syringe into the drug solution bag.

A method using a metal needle is known as a method of sucking a drug solution from a vial into a syringe. In this method, a metal needle attached to the tip of the syringe is pierced through the rubber stopper of the vial, and the drug solution is sucked into the syringe through the metal needle. In this method, the inside of the vial becomes negative pressure by drawing the drug solution into the syringe, so the operation is complicated and requires skill.

Patent Literature 1 describes a transfer tool having a sharp tip and formed with a liquid channel and a gas channel. The liquid channel extends along the longitudinal direction of the transfer device and penetrates the transfer device. One end of the gas flow path is open near the tip of the transfer tool, and the other end is communicated with a vent opening toward the outside. A one-way valve is provided in the vent. A one-way valve allows gas to flow from the vent to the puncture needle, but inhibits gas from flowing vice versa. Connect the transfer device to the syringe and then pierce the vial with the transfer device. The syringe and vial communicate through the liquid flow path. The vial communicates with the outside world through a gas flow path and a one-way valve. When the medicinal solution in the vial is sucked into the syringe through the liquid channel, air from the outside world flows into the vial through the one-way valve and the gas channel. No negative pressure is generated within the vial. Therefore, even an unskilled person can easily draw the drug solution from the vial into the syringe.

The drug solution in the vial may contain dangerous drugs such as anticancer drugs. In this case, if the chemical solution or the chemical gas vaporized from the chemical solution leaks out to the outside, the worker may be exposed to chemical exposure. It is generally believed that the above-described delivery device with a one-way valve on the gas flow path is effective in preventing leakage of drug gas to the outside world.

JP-A-07-100187

However, in reality, there are cases where the one-way valve is not completely closed and a slight gap is opened. In such cases, drug gas within the vial may enter the gas flow path and escape to the outside world through the gap in the one-way valve. In addition, if the plunger of the syringe is pushed vigorously while the syringe is connected to the vial via the transfer tool, the pressure inside the vial rises rapidly, and this pressure rise is transmitted to the one-way valve through the gas flow path. As a result, the one-way valve may be deformed abnormally, and the drug gas in the vial may leak out to the outside.

SUMMARY OF THE INVENTION An object of the present invention is to reduce the possibility that a drug gas in a vial leaks out to the outside in the operation of taking out a drug solution from the vial, thereby improving safety.

The vial adapter of the present invention comprises a needle with a sharp tip and a female connector. A liquid channel and a gas channel extending along the longitudinal direction of the puncture needle are provided in the puncture needle. The liquid channel communicates with the female connector. The gas flow path communicates with a vent open to the outside. Allowing gas to flow from the vent to the gas channel on the gas communication path that communicates the gas channel in the puncture needle and the vent, and allowing the gas to flow from the gas channel to the vent. A one-way valve is provided to inhibit flow. The gas communication passage comprises a narrow passage having a smaller cross-sectional area than the gas passage between the gas passage and the one-way valve.

According to the present invention, it is possible to reduce the possibility that the drug gas generated in the vial leaks to the outside through the vent. Therefore, the vial adapter of the present invention reduces the possibility of the worker being exposed to the drug in the operation of taking out the drug solution from the vial, thereby improving safety.

FIG. 1 is a top perspective view of a vial adapter according to Embodiment 1 of the present invention. FIG. 2 is a bottom perspective view of the vial adapter according to Embodiment 1 of the present invention. 3 is a cross-sectional view of the vial adapter according to Embodiment 1 of the present invention along a plane including line 3-3 of FIG. 1. FIG. 4 is an exploded perspective view of the vial adapter according to Embodiment 1 of the present invention. FIG. FIG. 5A is a perspective view of a ventilation tube according to Embodiment 1 of the present invention. FIG. 5B is a perspective view of the ventilation tube according to Embodiment 1 of the present invention viewed from another direction. FIG. 5C is a cross-sectional view of the vent pipe according to Embodiment 1 of the present invention. FIG. 6 is a cross-sectional view of an example vial to which the vial adapter of the present invention is attached. FIG. 7 is a side view of the vial adapter according to Embodiment 1 of the present invention attached to a vial. 8 is a cross-sectional view of the vial adapter and vial taken along a plane containing line 8-8 of FIG. 7; FIG. 9 is a side view of a male connector and a syringe connected to the vial adapter according to Embodiment 1 of the present invention. FIG. 10 is a partially enlarged cross-sectional view of a male connector and a syringe connected to the vial adapter according to Embodiment 1 of the present invention; FIG. 11 is a side view showing a state in which a vial and a syringe are connected via the vial adapter according to the first embodiment of the present invention; FIG. 12 is a partially enlarged cross-sectional view of the vial adapter and its vicinity along a plane including line 12-12 of FIG. 11; FIG. FIG. 13 is a cross-sectional view of a vial adapter according to Embodiment 2 of the present invention. 14A is a perspective view of a ventilation tube according to Embodiment 2 of the present invention. FIG. FIG. 14B is a perspective view of the ventilation tube according to Embodiment 2 of the present invention viewed from another direction; FIG. 14C is a cross-sectional view of a ventilation tube according to Embodiment 2 of the present invention. FIG. 15 is a cross-sectional view of a vial adapter according to Embodiment 3 of the present invention. 16 is a partially enlarged cross-sectional view of a vial adapter according to Embodiment 3 of the present invention taken along a plane including line 16-16 of FIG. 15; FIG. 17A is a perspective view of a ventilation tube according to Embodiment 3 of the present invention. FIG. 17B is a cross-sectional view of a ventilation tube according to Embodiment 3 of the present invention. FIG.

In the vial adapter of the present invention described above, the narrow passage may be defined by a first part and a second part that are different from each other. According to this aspect, when the first part and the second part are combined, a narrow path is formed as a gap between both parts. This is advantageous in simplifying the construction of the vial adapter with the narrow passageway and in facilitating its manufacture.

The first component may integrally include the puncture needle. Such an aspect is advantageous in reducing the number of parts constituting the vial adapter, simplifying the structure of the vial adapter, and facilitating its manufacture.

The one-way valve may be attached to the second part. Such an aspect is advantageous in reducing the number of parts constituting the vial adapter, simplifying the structure of the vial adapter, and facilitating its manufacture.

A cross-sectional area of the narrow passage may be 65% or less of a cross-sectional area of the gas channel in the puncture needle. Such an aspect is advantageous in further reducing the possibility that drug vapor generated in the vial escapes to the outside world through the vent.

The narrow passage may have a length of 3 mm or more. Such an aspect is advantageous in further reducing the possibility that drug vapor generated in the vial escapes to the outside world through the vent.

The vial adapter of the present invention may further comprise a plug capable of opening and closing the vent. Such an aspect is advantageous in further reducing the possibility that drug vapor generated in the vial escapes to the outside world through the vent.

The female connector may include a partition member having a linear slit. The partition member may function as a self-closing valve. Such an aspect is advantageous in reducing the possibility that the drug gas generated in the vial leaks out from the female connector to the outside when the vial adapter of the present invention is attached to the vial.

The vial adapter of the present invention may further include a claw configured to engage with the vial when the puncture needle punctures the stopper of the vial. Such an aspect is advantageous in reducing the possibility of the vial adapter unintentionally separating from the vial and leaking the drug solution or gaseous solution to the outside.

The present invention will be described in detail below while showing preferred embodiments. However, it goes without saying that the present invention is not limited to the following embodiments. Each figure referred to in the following description shows, for convenience of explanation, the main members constituting the embodiment of the present invention in a simplified manner. Accordingly, the present invention may include optional members not shown in the following figures. Also, each member shown in the following figures may be changed or omitted within the scope of the present invention. In the drawings cited in the description of each embodiment, members corresponding to the members shown in the drawings cited in the preceding embodiment are denoted by the same reference numerals as those in the drawings of the preceding embodiment. be. Duplicate descriptions of such members are omitted, and the descriptions of the preceding embodiments should be appropriately considered.

(Embodiment 1)
FIG. 1 is a top perspective view of a vial adapter 1 according to Embodiment 1 of the present invention. FIG. 2 is a perspective view of the vial adapter 1 as seen from below. FIG. 3 is a cross-sectional view of vial adapter 1 taken along a plane including line 3--3 of FIG. The vial adapter 1 comprises a puncture needle (also called a bottle needle) 20 and a female connector 50 . Puncture needle 20 and female connector 50 are arranged substantially coaxially. For convenience of explanation below, the direction parallel to the longitudinal direction of the puncture needle 20 will be referred to as the "vertical direction". In the vertical direction, the female connector 50 side is called the "upper" side, and the puncture needle 20 side is called the "lower" side. A direction perpendicular to the vertical direction is called a “horizontal direction”. However, "top", "bottom", and "horizontal" do not mean the orientation of the vial adapter 1 during actual use. FIG. 4 is an exploded perspective view of the vial adapter 1. FIG. The vial adapter 1 includes a body 10 , a vent tube 30 , a one-way valve 40 , a vent cap 45 , a septum member 55 and a cap 57 .

As shown in FIG. 2, the puncture needle 20 has a straight bar shape with a sharp tip 21. As shown in FIG. As shown in FIG. 3 , a liquid channel 24 and a gas channel 25 independent of each other extend in the puncture needle 20 along the longitudinal direction (vertical direction) of the puncture needle 10 . The lower end of liquid channel 24 opens toward the outside in the vicinity of tip 21 of puncture needle 20 . The upper end of liquid channel 24 communicates with lumen 52 of female connector 50 . The lower end of the gas channel 25 opens toward the outside at a position near the tip 21 of the puncture needle 20 and closer to the tip 21 than the opening of the liquid channel 24 . The upper end of the gas channel 25 communicates with the tubular portion 12 . The tubular portion 12 has an inner peripheral surface that is a substantially cylindrical surface and extends along the horizontal direction. One axial end of the tubular portion 12 is open and the other end is closed. Tubular portion 12 is arranged between puncture needle 20 and female connector 50 . The gas flow path 25 opens to the inner peripheral surface of the tubular portion 12 .

The female connector 50 includes a tubular portion 51 having a substantially cylindrical shape, a partition member (hereinafter referred to as “septum”) 55 provided at the upper end of the tubular portion 51 , and a cap 57 covering the septum 55 . Cylindrical portion 51 communicates with liquid channel 24 in puncture needle 20 . The septum 55 is a thin plate made of an elastic material such as rubber and having a circular plan view shape. A linear slit (notch) 56 is formed in the center of the septum 55 so as to vertically penetrate the septum 55 . A septum 55 is placed on the upper end of the tubular portion 51 , and a cap 57 is attached to the tubular portion 51 from above the septum 55 . The septum 55 is vertically sandwiched between the cylindrical portion 51 and the cap 57 . A slit 56 in the septum 55 is exposed through an opening 58 formed in the upper surface of the cap 57 . The slit 56 in the initial state is closed liquid-tight and air-tight (see FIGS. 1 and 3). When a cylindrical male member 130 (see FIG. 10, which will be described later) having no sharp tip is inserted into the slit 56, the septum 55 is elastically deformed, and the internal cavity 52 of the female connector 50 and the male member 130 communicate with each other ( (see FIG. 12, which will be described later). When the male member 130 is pulled out from the septum 55, the septum 55 immediately returns to its initial state, and the slit 56 is closed liquid-tight and air-tight. Thus, septum 55 functions as a self-closing valve. Such a self-closing type female connector 50 is also called a "needleless port".

A base 27 projecting horizontally is connected to the proximal end of the puncture needle 20 . A lower surface (surface on the puncture needle 20 side) 28 of the base 27 is a flat surface parallel to the horizontal direction (see FIG. 2). A pair of arms 60 are provided on the base 27 symmetrically with respect to the puncture needle 20 . Each arm 60 extends substantially horizontally from the base 27 toward the outside (the side away from the puncture needle 20) and then downward (the side of the tip 21 of the puncture needle 20). A claw 62 protruding toward the puncture needle 20 is provided at the tip of the arm 60 . Two ribs 65 extend downward from each claw 62 . The rib 65 is a plate-shaped object along a plane parallel to the vertical direction. A lower edge 66 of the rib 65 is inclined upward so as to approach the puncture needle 20 . The upper end of edge 66 terminates at the tip of claw 62 (closest to puncture needle 20).

The arm 60 has a cantilever support structure with a connection portion with the base 27 as a fixed end. The arm 60 can be elastically deformed relatively easily. A claw 62 and a rib 65 are provided at the free end of arm 60 . Arm 60 can be elastically deformed such that claw 62 and rib 65 move away from puncture needle 20 . Each arm 60 can deform independently of the other.

5A is a perspective view of the ventilation tube 30 viewed from the distal end side, and FIG. 5B is a perspective view of the ventilation tube 30 viewed from the proximal end side. 5C is a cross-sectional view of the vent pipe 30. FIG. The ventilation tube 30 has a bottomed tubular shape including a tubular body 32 having a hollow, substantially cylindrical shape and a bottom plate 39 closing an opening on the base end side of the tubular body 32 . A substantially disc-shaped flange 34 protrudes radially outward from the outer peripheral surface of the cylinder body 32 . The flange 34 is arranged at a position slightly closer to the opening 33 from the axial center of the cylinder body 32 .

A groove 35 is formed in the outer peripheral surface of the cylinder body 32 closer to the bottom plate 39 than the flange 34 . The grooves 35 include a first groove 35a extending from the base end (bottom plate 39 side end) of the cylinder body 32 along the axial direction for a predetermined length, and a first groove 35a extending in the circumferential direction of the cylinder body 32 over a range of about 180 degrees. 2 grooves 35b. One end of the second groove 35b is connected to the terminal end of the first groove 35a, and the other end of the second groove 35b is connected to a through hole 36 penetrating the cylinder body 32 in the radial direction.

As shown in FIG. 3 , the portion of the ventilation tube 30 closer to the bottom plate 39 than the flange 34 is fitted into the tubular portion 12 of the main body 10 . Vent tube 30 is inserted into tubular portion 12 until flange 34 abuts the open end of tubular portion 12 . Flange 34 defines the depth of insertion of vent tube 30 into tubular portion 12 . A bottom plate 39 of the ventilation tube 30 and the bottom surface of the tubular portion 12 are separated from each other with a gap 15 therebetween. The gas channel 25 communicates with the gap 15 . The inner peripheral surface of the tubular portion 12 is in airtight contact with the outer peripheral surface of the tubular body 32 except for the groove 35 . The inner peripheral surface of the tubular portion 12 and the grooves 35 (the first and second grooves 35a and 35b) form flow paths that allow the gaps 15 and the through holes 36 to communicate with each other.

A one-way valve 40 is fitted in the opening 33 (see FIGS. 4, 5A and 5C) of the vent tube 30 . A vent cap 45 is then attached to the vent tube 30 over the one-way valve 40 . A vent cap 45 secures the one-way valve 40 to the vent tube 30 . The vent cap 45 has a vent hole 46 opposite the one-way valve 40 . The vent 46 is a through hole that opens toward the outside. A plug 47 is connected to the vent cap 45 via a freely bendable band 48 (see FIGS. 1 and 2). The plug 47 can repeatedly open and close the vent 46 . Plug 47 may hermetically seal vent 46 .

The gas flow path 25, the gap 15, the first groove 35a, the second groove 35a, the through hole 36, the lumen 31 of the ventilation cylinder 30, and the ventilation port 46 are communicated in this order. In the present invention, the channel that connects the gas channel 25 and the vent 46 is referred to as a "gas communication channel". A one-way valve 40 is provided on the gas communication path, more specifically between the lumen 31 and the vent 46 . One-way valve 40 allows ambient air to flow from vent 46 toward lumen 31 (i.e., in the forward direction) while gas within lumen 31 conversely flows through vent 46 . flow toward (i.e., in the opposite direction) is prohibited. The one-way valve 40 is a valve that allows the fluid to flow in only one direction and prevents the fluid from flowing in the opposite direction, and is also called a check valve or check valve. The configuration of the one-way valve 40 is not limited as long as it has such functions. In this embodiment, a duckbill type one-way valve is used as the one-way valve 40 . The duckbill type one-way valve 40 is advantageous for downsizing the vial adapter 1 .

The cross-sectional area of gas flow path 25 in puncture needle 20 is substantially constant in its longitudinal direction. The cross-sectional area of the gas communication path connecting the gas flow path 25 and the vent 46 is the smallest in the second groove 35b. The cross-sectional area of the channel formed by the second groove 35b is constant in the longitudinal direction of the second groove 35b. The cross-sectional area of the channel in the second groove 35b is smaller than the cross-sectional area of the gas channel 25. As shown in FIG. In one embodiment, the cross-sectional area of the gas channel 25 is 0.78 mm ² and the cross-sectional area of the channel at the second groove 35b is 0.49 mm ² . In the present invention, the "cross-sectional area" of a channel means the area of the channel on a plane perpendicular to the flow direction of the fluid (for example, gas) flowing through the channel.

As shown in FIG. 4, the main body 10 includes all the elements that make up the vial adapter 1 except for the vent tube 30, the one-way valve 40, the vent cap 45, the septum member 55 and the cap 57. As shown in FIG. Each of the main body 10 and the vent cap 45 is preferably integrally manufactured as one piece by injection molding a resin material. The resin material that can be used for the main body 10 and the ventilation cap 45 is not limited, but polyethylene, polypropylene, polycarbonate, styrene ethylene, polyethylene terephthalate, polybutylene terephthalate, butylene styrene block copolymer, etc. can be exemplified. Polyolefin-based resins such as polyethylene and polypropylene are preferable in view of the fact that they are used for various purposes and that they have a portion that is elastically deformed by bending. Materials for the vent pipe 30 and the cap 45 are not limited, but are preferably hard materials. For example, resin materials such as polycarbonate, polypropylene, polyacetal, polyamide, hard polyvinyl chloride, and polyethylene can be used. The materials of the one-way valve 40 and the partition member 55 are not limited, but are preferably soft materials having rubber elasticity (so-called elastomers). A plastic elastomer or the like can be used. In Embodiment 1, the main body 10 is integrally formed entirely as a single component, but may be configured by combining two or more separately manufactured components.

The vial adapter 1 of Embodiment 1 is used when a drug solution in a vial is aspirated into a syringe. A method of using the vial adapter 1 will be described.

FIG. 6 is a cross-sectional view of an example vial 80. As shown in FIG. The vial 80 is a closed container in which a stopper (rubber stopper) 86 is fitted into a mouth (opening) 83 that opens upward in a bottle body 81 to seal the mouth 83 airtight and liquid-tight. The vial 80 contains a drug solution (not shown). The bottle body 81 is made of a hard material such as glass that does not substantially deform. An enlarged flange 82 surrounds the mouth 83 . A step is formed between the flange 82 and a constricted portion 84 immediately below the flange 82 based on the difference in outer diameter between the two.

The plug 86 has approximately the same outer diameter as the flange 82 . A cap 88 is attached to the stopper 86 and the flange 82 to prevent the stopper 86 from falling out of the mouth 83 of the bottle body 81 . The cap 88 is made of a sheet of metal (eg, aluminum), resin, or the like, and is in close contact with the plug body 86 and the flange 82 . The lower end of the cap 88 extends below the substantially cylindrical outer peripheral surface of the flange 82 . The upper end of the cap 88 extends to the upper surface of the stopper 86 . A central region of the upper surface of the plug 86 is exposed to the outside through a circular opening 88a provided in the cap 88. As shown in FIG. Note that the vial 80 may not have the cap 88 .

As shown in FIG. 7, the vial adapter 1 is attached to the vial 80 . 8 is a cross-sectional view taken along a plane containing line 8-8 of FIG. 7. FIG.

The puncture needle 20 penetrates the plug 86 . The openings of the liquid channel 24 and the gas channel 25 formed in the puncture needle 20 on the distal end 21 side are positioned below the stopper 86 . The liquid channel 24 and the gas channel 25 are in communication with the lumen of the vial 80 . The lower surface 28 (see FIG. 2) of the base 27 of the vial adapter 1 abuts the upper surface of the stopper 86 (or cap 88) of the vial 80. As shown in FIG. A pawl 62 fits into a waisted portion 84 and engages a flange 82 (see FIG. 6). Even if a tensile force or vibration is applied to the vial adapter 1 and the vial 80, the puncture needle 10 will not unintentionally come out of the plug 86.

Although detailed description is omitted, simply by pointing the tip 21 of the puncture needle 20 toward the stopper 86 of the vial 80 and pushing the vial adapter 1 toward the vial 80, the vial adapter 1 can be configured as shown in FIGS. can be attached to the vial 80. The edge 66 (see FIG. 2) of the rib 65 of the vial adapter 1 slides over the upper edge 88b (see FIG. 6) of the cap 88 of the vial 80 while contacting the upper edge 88b. As the puncture needle 20 is inserted into the plug 86, the arm 60 is bent and deformed. The operator does not have to touch the arm 60 or the rib 65. Attaching the vial adapter 1 to the vial 80 is easy.

FIG. 9 is a side view of the male connector 120 and syringe 100 connected to the vial adapter 1. FIG. FIG. 10 is a partially enlarged cross-sectional view of the male connector 120 and its vicinity.

The syringe 100 has a barrel (outer cylinder) 101 and a plunger 110 . The barrel 101 has a hollow cylindrical shape, is open at one end (upper end), and has a tip (nozzle) 102 at the other end (lower end). The tube tip 102 has a rod-shaped male member 103 communicating with the inner cavity of the barrel 101 and a cylindrical outer cylinder 105 surrounding the male member 103 . The outer peripheral surface of the male member 103 is a tapered surface (so-called male tapered surface) in which the outer diameter becomes smaller as the tip of the male member 103 is approached. A female screw 106 is formed on the inner peripheral surface of the outer cylinder 105 (the surface facing the male member 103). A plunger 110 is removably inserted into an opening at the upper end of the barrel 101 . A gasket 112 is attached to the tip of the plunger 110 . Gasket 112 slides along the length of barrel 101 over the inner surface of barrel 101 forming a fluid tight seal therewith.

A male connector 120 is attached to the tube tip 102 . The male connector 120 has a cylindrical tubular portion (female luer) 123 . The inner peripheral surface of the tubular portion 123 is a tapered surface (female tapered surface) whose inner diameter increases toward the distal end of the tubular portion 123 . A male screw (spiral projection) 126 is provided on the outer peripheral surface of the tubular portion 123 . Male member 103 of syringe 100 is fitted into tubular portion 123 . The male tapered surface of the male member 103 and the female tapered surface of the tubular portion 123 are taper-fitted in a liquid-tight manner. Male thread 126 of tubular portion 123 is screwed into female thread 106 of outer cylinder 105 .

The male connector 120 further comprises a straight rod-shaped male member 130 and a cylindrical hood 135 surrounding the male member 130 . A channel 131 communicating with the tubular portion 123 is formed in the male member 130 . The channel 131 extends along the longitudinal direction of the male member 130 and communicates with a horizontal hole 132 provided in the vicinity of the distal end of the male member 130 . A lock lever 137 is provided in a notch provided in the hood 135 . The lock lever 137 is an elongated plate-like object extending substantially parallel to the male member 130 . The lock lever 137 has a cantilever support structure with its upper end as a fixed end and its lower end as a free end in FIG. A claw 138 projects from the free end of the lock lever 137 toward the male member 130 . An operating arm 139 extends from the outer surface of the lock lever 137 (the surface opposite to the male member 130 ) toward the tubular portion 123 . When the tip of the operating arm 139 is pushed toward the tubular portion 123 , the lock lever 137 is elastically bent and deformed so that the claw 138 is separated from the male member 130 .

Male member 130 is covered with cover 140 . Like the partition member 55, the cover 140 is made of a soft material having rubber elasticity (so-called elastomer). The cover 140 has a hollow tubular wall 142 and a head 144 provided at the tip of the tubular wall 142 . The tip of male member 130 is inserted into a cylindrical hole provided in head 144 . The lateral hole 132 of the male member 130 is closed by the inner peripheral surface of the hole. A linear slit (notch) 145 is formed through the head at the deepest part of the hole.

As shown in FIG. 11, the syringe 100 (see FIGS. 9 and 10) is connected via the male connector 120 to the vial adapter 1 (see FIGS. 7 and 8) attached to the vial 80. As shown in FIG. 12 is a partially enlarged cross-sectional view taken along a plane including line 12-12 of FIG. 11. FIG. Female connector 50 is inserted into hood 135 . A claw 138 of the lock lever 137 is engaged with the stepped portion 53 (see FIG. 2) of the female connector 50 . Even if a pulling force or vibration is applied to the vial adapter 1 and the male connector 120, the vial adapter 1 and the male connector 120 will not separate.

The male member 130 penetrates through the slit 145 (see FIG. 10) of the cover 140 and through the slit 56 of the septum 55 (see FIGS. 1 and 3). A lateral bore 132 of male member 130 is exposed within lumen 52 of female connector 50 . The septum 55 is greatly deformed toward the lumen 52 by inserting the male member 130 and being pushed by the head 144 of the cover 140 . A cylindrical wall 142 of the cover 140 is compressed and deformed in the longitudinal direction of the male member 130 .

As shown in FIG. 12, the vial 80, the liquid channel 24, the lumen 52 of the female connector 50, the channel 131, the tubular portion 123, the male member 103 and the barrel 101 are communicated in order. With vial 80 up and syringe 100 down, plunger 110 is pulled. The drug solution in vial 80 is sucked into syringe 100 through liquid channel 24 . When the drug solution flows out from the vial 80, the air in the outside world flows through the vent port 46, the one-way valve 40, the lumen 31 of the vent pipe 30, the through hole 36, the second groove 35b, the first groove 35a, the gap 15, and the gas flow path. 25 in turn into the vial 80 . By connecting the vial 80 to the syringe 100 via the vial adapter 1 in this way, the drug solution in the vial 80 can be sucked into the syringe 100 without generating a negative pressure in the vial 80 . Even an inexperienced operator can easily perform the work of sucking the drug solution into the syringe 100 .

After the medicinal solution in the vial 80 is sucked into the syringe 100, the operation arm 139 is pushed to release the engagement between the claw 138 and the female connector 50. As shown in FIG. Separate the male connector 120 from the vial adapter 1 . The male connector 120 is connected to a port (not shown) of the infusion bag, and the drug solution in the syringe 100 is injected into the infusion bag. The vial adapter 1 separated from the male connector 120 is discarded while attached to the vial 80 .

The vial adapter 1 has a second groove 35 b having a smaller cross-sectional area than the gas flow path 25 on the gas communication path between the gas flow path 25 and the one-way valve 40 . The action of the second groove 35b will be described.

Depending on the temperature around the vial 80 and the like, the drug gas may vaporize from the drug solution in the vial 80 . When the vial adapter 1 is attached to the vial 80 (FIGS. 7 and 8 or FIGS. 11 and 12) for an extended period of time, the drug gas flows into the gas flow path 25 and toward the vent 46 .

Consider a case where the gas communication path that communicates between the gas flow path 25 and the vent 46 does not have a portion having a flow path cross-sectional area smaller than that of the gas flow path 25, unlike in the first embodiment. In this case, the drug gas reaches the one-way valve 40 relatively easily. One-way valve 40 is configured to inhibit gas flow from lumen 31 toward vent 46 (ie, in the opposite direction). However, the one-way valve 40 may not be completely closed in its natural state due to various causes such as manufacturing errors. As the drug gas vaporizes within vial 80, the pressure within vial 80 rises slightly, but this pressure increase is small and slow enough to cause one-way valve 40 to close. Therefore, the drug gas passes through a small gap in the one-way valve 40 and leaks out of the vent 46 to the outside world. If the drug in the vial 80 is a dangerous drug such as an anticancer drug, the worker will be exposed to the dangerous drug.

In contrast, in Embodiment 1, the second groove 35b is provided on the gas communication path between the gas flow path 25 and the one-way valve 40. As shown in FIG. A relatively small cross-sectional area continues over a predetermined length in the second groove 35b. It takes a very long time for the drug gas to pass through the second groove 35b while diffusing within the second groove 35b. It is extremely difficult for the drug gas to reach the one-way valve 40 . Therefore, even if the one-way valve 40 is not completely closed, the drug gas in the vial 80 will not leak out through the vent 46 to the outside world.

In addition, when the syringe 100 is connected to the vial 80 via the vial adapter 1 (FIGS. 11 and 12), if the plunger 110 is accidentally pushed into the barrel 101, the pressure inside the vial 80 rises sharply.

Consider a case where the gas communication path that communicates between the gas flow path 25 and the vent 46 does not have a portion having a flow path cross-sectional area smaller than that of the gas flow path 25, unlike in the first embodiment. In this case, the pressure rise in the vial 80 causes the gas to flow in the opposite direction through the gas communication passage. Ordinarily, reverse gas flow would act to force the one-way valve 40 to close. However, because the pressure in vial 80 rises rapidly and is abnormally high, one-way valve 40 is subjected to a sudden, abnormally high velocity reverse flow of gas. The one-way valve 40 instantaneously receives a high pressure exceeding the allowable limit and deforms abnormally, resulting in malfunction. Therefore, the drug gas in the vial passes through the one-way valve 40 and leaks out to the outside. If the drug in the vial 80 is a dangerous drug such as an anticancer drug, the worker will be exposed to the dangerous drug.

In contrast, in Embodiment 1, the second groove 35b is provided on the gas communication path between the gas flow path 25 and the one-way valve 40. As shown in FIG. A relatively small cross-sectional area continues over a predetermined length in the second groove 35b. A large pressure loss occurs in the second groove 35b. Therefore, the one-way valve 40 is not affected by a sudden, abnormally high-speed reverse gas flow. The one-way valve 40 is closed as in normal operation without abnormal deformation. The drug gas in the vial cannot pass through the one-way valve 40 and escape to the outside world.

As described above, the vial adapter 1 of Embodiment 1 reduces the possibility that the drug gas generated in the vial 80 leaks from the vent 46 to the outside. The vial adapter 1 reduces the possibility of the operator being exposed to the drug, and is excellent in safety.

In the above example, the second groove 35b extends over a range of approximately 180 degrees on the outer peripheral surface of the cylinder body 32. As shown in FIG. However, the second groove 35b is not limited to this. The second groove 35b may extend in the circumferential direction of the cylinder body 32 over a range larger than 180 degrees or a range smaller than 180 degrees. Alternatively, the second groove 35b may extend spirally on the outer peripheral surface of the cylinder body 31 . The spiral second groove 35b is advantageous in ensuring the required length of the second groove 35b.

A female connector 50 with which the liquid flow path 24 communicates has a septum 55 that functions as a self-closing valve. Therefore, when the vial adapter 1 is attached to the vial 80 and the male connector 120 is not connected to the vial adapter 1 (FIGS. 7 and 8), there is a low possibility that the medicinal gas will leak from the female connector 50 to the outside world. .

Except when the syringe 100 is operated to aspirate the drug solution in the vial 80, when the vial adapter 1 is attached to the vial 80 (FIGS. 7 and 8, and FIGS. 11 and 12), the vent 46 is is preferably sealed with a plug 47 . As a result, leakage of the medicinal gas from the ventilation port 46 can be prevented more reliably. Note that the plug 47 may be omitted.

(Embodiment 2)
FIG. 13 is a cross-sectional view of the vial adapter 2 according to Embodiment 2 of the present invention along the same plane as in FIG. The second embodiment differs from the first embodiment with respect to the vent pipe 230 . The second embodiment will be described below, focusing on the differences from the first embodiment.

14A is a perspective view of ventilation cylinder 230 viewed from the distal end side, and FIG. 14B is a perspective view of ventilation cylinder 230 viewed from the proximal end side. 14C is a cross-sectional view of vent tube 230. FIG. In the second embodiment, the portion of the cylinder body 32 from the flange 34 to the bottom plate 39 is slightly longer than in the first embodiment. A groove 235 is formed in the outer peripheral surface of the cylinder main body 32 closer to the bottom plate 39 than the flange 34 and the outer surface of the bottom plate 39 . The groove 235 includes a first groove 235 a extending from the base end (bottom plate 39 side end) of the cylinder body 32 along the axial direction for a predetermined length, and a second groove 235 b extending diametrically of the bottom plate 39 . The starting end of the first groove 235a is connected to one end of the second groove 235b, and the terminal end of the first groove 35b is connected to the through hole 36 penetrating the cylinder body 32 in the radial direction.

As shown in FIG. 13, the second groove 235b is parallel to the vertical direction, and the portion of the ventilation pipe 230 closer to the bottom plate 39 than the flange 34 is fitted into the tubular portion 12. As shown in FIG. When the flange 34 contacts the open end of the tubular portion 12, the bottom plate 39 of the vent pipe 230 is in airtight contact with the bottom surface of the tubular portion 12 except for the second groove 235b. The inner peripheral surface of the tubular portion 12 is in airtight contact with the outer peripheral surface of the tubular body 32 except for the first groove 235a. A channel is formed by the inner surface of the tubular portion 12 and the grooves 235 (first and second grooves 235a and 235b). The gas channel 25 communicates with the second groove 235b. Therefore, the grooves 235 (the first and second grooves 235a and 235b) form flow paths that allow the gas flow paths 25 and the through holes 36 to communicate with each other.

The gas flow path 25, the second groove 235a, the first groove 235a, the through hole 36, the lumen 31 of the ventilation cylinder 230, and the ventilation port 46 are communicated in this order. The cross-sectional area of the gas communication path connecting the gas flow path 25 and the vent 46 is the smallest in the second groove 235b. The cross-sectional area of the channel formed by the second groove 235b is constant in the longitudinal direction of the second groove 235b. The cross-sectional area of the channel at the second groove 235 b is smaller than the cross-sectional area of the gas channel 25 .

Similar to the vial adapter 1 of Embodiment 1, the vial adapter 2 of Embodiment 2 also has a second gas flow path having a smaller cross-sectional area than the gas flow path 25 on the gas communication path between the gas flow path 25 and the one-way valve 40 . It has two grooves 235b. Therefore, the vial adapter 2 reduces the possibility that the drug gas generated in the vial 80 leaks from the vent 46 to the outside world. The vial adapter 2 reduces the possibility of the operator being exposed to the drug and is excellent in safety.

In the above example, the second groove 235b extends straight on the bottom plate 39 of the ventilation pipe 230, but the second groove 235b is not limited to this. For example, the second groove 235 b may be curved or bent on the bottom plate 39 . Such second grooves 235b are advantageous in securing the necessary length of the second grooves 235b. Alternatively, instead of the groove, a through hole penetrating through the bottom plate 39 in a diametrical direction may be provided in the bottom plate 39 . The cross-sectional area of the through-hole is smaller than the cross-sectional area of the gas channel 25 .

Embodiment 2 is the same as Embodiment 1 except for the above. The description of the first embodiment also applies to the second embodiment.

(Embodiment 3)
FIG. 15 is a cross-sectional view along the same plane as in FIG. 3 of the vial adapter 3 according to Embodiment 3 of the present invention. 16 is a partially enlarged cross-sectional view of vial adapter 3 taken along a plane including line 16-16 of FIG. 15. FIG. Embodiment 3 differs from Embodiment 1 with respect to the vent pipe 330 and the shape of the inner surface of the tubular portion 12 into which the vent pipe 330 is fitted. The third embodiment will be described below, focusing on the differences from the first embodiment.

17A is a perspective view of the vent pipe 330 viewed from the tip side, and FIG. 17B is a cross-sectional view of the vent pipe 330. FIG. The vent pipe 330 does not have the bottom plate 39 and the through hole 36 that the vent pipe 30 of the first embodiment has. Both ends of the vent pipe 330 are open. A small-diameter portion 337 that is a relatively small-diameter cylindrical surface is formed on the outer peripheral surface of the cylinder main body 32 . The small-diameter portion 337 extends axially from a base end 338 (the end opposite to the opening 33 ) of the tubular body 32 over a region of a predetermined length. A tapered surface (female tapered surface) 336 whose inner diameter increases toward the base end 338 is formed on the inner peripheral surface of the cylinder main body 32 . The tapered surface 336 extends from the base end 338 in the axial direction of the tubular body 32 over a region of a predetermined length.

As shown in FIG. 15, a post 314 extends from the bottom surface of tubular portion 12 coaxially with tubular portion 12 . The outer peripheral surface of the columnar projection 314 is a tapered surface (male tapered surface) 316 whose outer diameter decreases toward the tip. However, a notch 317 is formed in the columnar projection 314 so that a portion of the tapered surface 316 forms a flat surface (see FIG. 16). The notch 317 is continuous along the axial direction of the columnar projection 314 from the base end of the columnar projection 314 (the bottom surface of the tubular portion 12 ) to the tip of the columnar projection 314 .

A portion of the ventilation tube 330 closer to the proximal end 338 than the flange 34 is fitted into the tubular portion 12 . When flange 34 abuts the open end of tubular portion 12, proximal end 338 of vent tube 330 and the bottom surface of tubular portion 12 are spaced apart. The inner peripheral surface of the tubular portion 12 is in airtight contact with the outer peripheral surface of the tubular body 32 except for the small diameter portion 337 . The tapered surface 336 of the ventilation tube 330 is airtightly taper-fitted with the tapered surface 316 of the columnar projection 314 except for the notch 317 . The inner peripheral surface of the ventilation cylinder 330 and the notch 317 of the columnar projection 314 form a flow path that allows the gas flow path 25 and the lumen 31 of the ventilation cylinder 330 to communicate with each other.

The gas flow path 25, the notch 317, the lumen 31 of the ventilation cylinder 330, and the ventilation port 46 are communicated in this order. The cross-sectional area of the gas communication path connecting the gas flow path 25 and the vent 46 is the smallest at the notch 317 . The cross-sectional area of the channel formed by the notch 317 is constant in the longitudinal direction of the notch 317 . The cross-sectional area of the channel at the notch 317 is smaller than the cross-sectional area of the gas channel 25 .

Similar to the vial adapter 1 of Embodiment 1, the vial adapter 3 of Embodiment 3 also has a cutout having a cross-sectional area smaller than that of the gas flow path 25 on the gas communication path between the gas flow path 25 and the one-way valve 40 . A notch 317 is provided. Therefore, the vial adapter 3 reduces the possibility that the drug gas generated in the vial 80 leaks from the vent 46 to the outside world. The vial adapter 3 reduces the possibility of the operator being exposed to the drug and is excellent in safety.

In Embodiment 3, the small-diameter portion 337 may not be provided on the outer peripheral surface of the ventilation cylinder 330 as long as the communication between the gas flow path 25 and the notch 317 is ensured.

The shape of the notch 317 can be changed arbitrarily. For example, notch 317 may be a groove having a constant width and a constant depth formed in tapered surface 316 . The groove may extend straight along the axial direction of the columnar projection 314, or may be curved or bent. Curved or bent grooves are advantageous for ensuring grooves of the required length. The notch 317 of the tapered surface 316 may be omitted, and instead, a groove (or notch) may be formed in the tapered surface 336 of the vent pipe 330 to allow the gas passage 25 and the lumen 31 to communicate with each other.

Embodiment 3 is the same as Embodiment 1 except for the above. The description of the first embodiment also applies to the third embodiment.

The above embodiments 1-3 are only examples. The present invention is not limited to Embodiments 1 to 3, and can be modified as appropriate.

The vial adapter of the present invention is provided with a "narrow passage" having a smaller cross-sectional area than the gas flow path 25 on the gas communication path between the gas flow path 25 and the one-way valve 40 . The narrow path is the second groove 35b in the first embodiment, the second groove 235b in the second embodiment, and the notch 317 in the third embodiment. However, the narrow streets of the present invention are not limited to these. The location where the narrow passage is provided can be selected arbitrarily in the gas communication path between the gas flow path 25 and the one-way valve 40 .

In the above embodiments 1-3, the narrow passages (35b, 235b, 317) were defined by separate parts, the body (10) and the vents (30, 230, 330). In this configuration, when the ventilation tube is assembled to the main body, a narrow passage is formed as a gap between the two. Since the structure of the main body and the ventilation pipe for forming the narrow passage can be simplified, the structure of the vial adapter as a whole is simplified, and the manufacturing of the vial adapter is facilitated. Unlike Embodiments 1 to 3, it is generally difficult to form a small-diameter long through-hole in the main body or ventilation pipe as a narrow path. Forming the slot between two pieces that are separate from each other facilitates the production of the slot and thus the manufacture of the vial adapter. However, the narrow passage of the present invention is not limited to that formed between the main body and the ventilation pipe. For example, either the main body or the ventilation tube may be provided with a continuous hole that functions as a narrow passage. Either the main body or the ventilation tube may be composed of a plurality of parts, and narrow passages may be formed between the plurality of parts.

In the above-described Embodiments 1 to 3, the puncture needle 20 is integrally provided with the main body (10), which is one of the parts that define the narrow passage, and the ventilation cylinder (30, 230) that is the other part that defines the narrow passage. , 330) were fitted with one-way valves 40 . This configuration is advantageous in reducing the number of parts that make up the vial adapter and in simplifying the configuration of the vial adapter and facilitating its manufacture. However, in the present invention, the main body (10) is composed of a plurality of parts such that the part defining the narrow passage (the part including the tubular part 12) is separate from the part including the puncture needle 20. good too. Also, the one-way valve 40 may be attached to a separate component (eg, main body 10) from the vent pipe (30, 230, 330) that defines the narrow passage.

A portion of the gas communication path between the gas flow path 25 and the one-way valve 40 may be composed of a flexible tube. In this case, the narrow passage may be provided on either the gas flow path 25 side or the one-way valve 40 side with respect to the tube. Alternatively, the tube may constitute the narrow passageway.

A smaller cross-sectional area of the narrow passage and a longer narrow passage are advantageous in reducing the possibility of leakage of the medicinal gas from the vent 46 to the outside. Specifically, the cross-sectional area of the narrow passage is preferably 0.49 mm ² or less, more preferably 0.40 mm ² or less, particularly 0.35 mm ^{2 or} less. Also, the length of the narrow passage is preferably 3 mm or more, more preferably 4 mm or more, and particularly preferably 5 mm or more. However, if the cross-sectional area of the narrow passage is too small, or if the narrow passage is too long, air flow resistance in the narrow passage increases, making it difficult to aspirate the drug solution in the vial 80 into the syringe 100. . From the viewpoint of ensuring the operability of sucking the chemical solution, the cross-sectional area of the narrow passage is preferably 0.20 mm ² or more, more preferably 0.25 mm ² or more, and the length of the narrow passage is 8 mm or less. Furthermore, it is preferably 7 mm or less. In general, the cross-sectional area of the narrow path is 65% or less, more preferably 55% or less, particularly preferably 50% or less of the cross-sectional area of the gas flow channel 25, and 20% or more of the cross-sectional area of the gas flow channel 25. is preferably 25% or more, particularly 30% or more.

In order to reduce the possibility of leakage of the drug gas from the vent 46 to the outside, it is preferable that the cross-sectional area of the gas flow path 25 is also small. However, it is generally difficult to form a small-diameter gas flow path 25 in a puncture needle 20 having a desired length. When the puncture needle 20 is resin-molded, the cross-sectional area of the gas flow path 25 is preferably 0.78 mm ² or more, more preferably 0.80 mm ² or more, from the viewpoint of ensuring good moldability. However, when the cross-sectional area of the gas flow path 25 increases, the outer diameter of the puncture needle 20 increases, and a greater force is required to puncture the plug 86 with the puncture needle 20 . Therefore, the cross-sectional area of the gas flow path 25 is preferably 1.0 mm ² or less, more preferably 0.90 mm ² or less.

The female connector communicating with the liquid channel 24 is not limited to the needleless port shown in the first to third embodiments. For example, the female connector may have a self-closing valving function other than the septum 55 . A female connector need not have a self-closing valve function. In this case, it is preferable to provide a mechanism for temporarily closing the channel between the liquid channel 24 and the female connector in order to prevent the drug gas from leaking out from the female connector to the outside world. A part of the channel that connects the liquid channel 24 and the female connector may be configured with a flexible tube.

The configuration of the pawl 62 and arm 60 that engage the vial 89 can be changed as appropriate. The number of claws 62 and arms 60 provided in the vial adapter need not be two, and may be one or three or more. For example, four claws may be arranged at equal angular intervals with respect to the puncture needle 20 . The number of claws and arms need not be the same. For example, one arm may be provided with a plurality of claws. A single common claw may be supported by a plurality of arms. The vial adapter of the present invention may not have vial-engaging claws.

A sterilization filter may be provided between the one-way valve 40 and the vent 46 . The sterilization filter is advantageous in preventing external bacteria from entering the syringe 100 through the vial 80 from the vent 46 together with air when the liquid in the vial 80 is aspirated into the syringe 100 .

In Embodiments 1 to 3 described above, the vent cap 45, which is a member separate from the one-way valve 40, is provided with the vent 46, but the vent 46 of the present invention is not limited to this. For example, the edge defining the opening facing the outside world of the one-way valve 40 may be a vent.

The liquid in the vial 80 is not limited to drug solutions containing dangerous drugs such as anticancer drugs. It may be a drug solution containing a drug other than a dangerous drug, or may be any liquid other than the drug solution (for example, a nutrient).

The configuration of the male connector 120 connected to the female connector 50 is not limited to the first to third embodiments described above. Instead of using the male connector 120 , the tip (male member) of a general syringe without the outer cylinder 105 may be inserted into the slit 56 of the female connector 50 .

The field of application of the present invention is not limited, and it can be used in a wide range of fields such as medicine, food, and chemistry. Among them, the field of medicine is preferred. In particular, the present invention can be used when preparing a drug solution using a vial storing a dangerous drug solution such as an anticancer drug.

1, 2, 3 vial adapter 10 body (first part)
20 puncture needle 21 puncture needle tip 24 liquid channel 25 gas channel 30 ventilation tube (second component)
35b Second groove (narrow path)
40 One-way valve 46 Vent 47 Plug 50 Female connector 55 Partition member (septum)
56 Slit 62 Claw 80 Vial 86 Vial stopper 230 Vent tube (second component)
235b second groove (narrow path)
317 Notch (narrow road)
330 ventilation pipe (second part)

Claims (9)

A vial adapter comprising a puncture needle having a sharp tip and a female connector,
a liquid channel and a gas channel extending along the longitudinal direction of the puncture needle are provided in the puncture needle;
the liquid channel communicates with the female connector;
the gas flow path communicates with a vent opening toward the outside,
Allowing gas to flow from the vent to the gas channel on the gas communication path that communicates the gas channel in the puncture needle and the vent, and allowing the gas to flow from the gas channel to the vent. A one-way valve is provided to prohibit flow,
The vial adapter, wherein the gas communication path has a narrow passage having a smaller cross-sectional area than the gas flow path between the gas flow path and the one-way valve. 2. The vial adapter of claim 1, wherein the narrow passageway is defined by first and second parts that are different from each other. 3. The vial adapter according to claim 2, wherein said first component integrally comprises said puncture needle. 4. A vial adapter according to claim 2 or 3, wherein said one-way valve is attached to said second part. The vial adapter according to any one of claims 1 to 4, wherein the cross-sectional area of said narrow passage is 65% or less of the cross-sectional area of said gas flow path in said puncture needle. The vial adapter according to any one of claims 1 to 5, wherein the narrow passage has a length of 3 mm or more. The vial adapter according to any one of claims 1 to 6, further comprising a plug capable of opening and closing the vent. The vial adapter according to any one of claims 1 to 7, wherein the female connector includes a partition member having a linear slit formed therein, and the partition member functions as a self-closing valve. The vial adapter according to any one of claims 1 to 8, further comprising a claw configured to engage with the vial when the puncture needle punctures the stopper of the vial.