JP2019047957A - Closed drug transfer system - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a closed drug transfer system capable of easily extracting a liquid containing a drug without creating a negative pressure in a vial. A closed drug transfer system 1 includes a vial adapter 3 including a hollow needle member 32 and a gripping member 34, and a female connector 4 communicating with the inside of the vial bottle 2 by a first path 322 of the hollow needle member 32. The container 5 is closed by the flexible member 6 and communicates with the inside of the vial bottle 2 by the second path 323 of the hollow needle member 32. When the chemical solution is injected, the gas in the vial bottle 2 is saved in the container 5, and when the liquid is extracted, the gas in the container 5 is supplied into the vial bottle 2. Around the opening of the path 323, a rib 53 that allows gas flow between the container 5 and the path 323 is provided. [Selection diagram] Fig. 2

Description

  The present invention relates to a closed drug delivery system.

  In the past, when dealing with anticancer agents that may adversely affect normal cells and tissues, and drugs that contain radioactive isotopes for testing, etc., closed-type drugs are used to avoid exposure to medical personnel etc. A transport system is used.

  The closed drug delivery system includes, for example, a vial adapter that holds a vial in which a drug such as the anticancer drug is sealed, and a connection member that connects the vial adapter and a medical device such as a syringe. It has been known. The vial adapter has a hollow needle member which is pierced by a rubber plug for sealing the opening of the vial, and a plurality of grips which hold the neck of the vial when the hollow needle member is pierced by the vial. And a gripping member.

  According to the closed drug delivery system, the connecting member is a medical device such as a syringe or the like in a state where the hollow needle member of the vial adapter is pierced by the vial and the vial is held by the holding member By connecting them, it is possible to inject a chemical solution such as physiological saline into the vial in a state of being shielded from the outside air.

  By the way, since a gas such as air coexists with the drug in the vial in addition to the drug, when injecting the drug into the vial as described above, the space in the vial is filled by the injection of the drug. There is a problem that when the gas narrows down and the gas loses place, the medicine may fly explosively from the mouth of the vial and the medical worker or the like may be exposed to the droplets or the aerosol.

  Therefore, in order to solve the above problem, a gas container is provided for withdrawing the gas in the vial when injecting the chemical solution, and the hollow needle communicates the inside of the vial with the inside of the connection member. There is known a closed drug delivery system comprising one path and a second path connecting the inside of the vial and the gas container (see, for example, Patent Document 1).

JP-A-2014-521491

  By the way, in the closed drug delivery system, a medical instrument such as a syringe or the like is connected to the connection member in a state where the hollow needle member of the vial adapter is pierced by the vial and the vial is held by the holding member. It may be used also for the application which extracts the liquid containing medicine from the vial in a state of being shielded from the open air by connecting. In this case, if the inside of the vial is shut off from the outside air, the inside of the vial will be under negative pressure, which may make it difficult to extract the liquid. In order to solve this problem, in the closed drug delivery system described in Patent Document 1, when a predetermined amount of gas is stored in the gas container and the liquid containing the drug is extracted from the vial, By supplying the gas stored in the gas container to the vial, negative pressure in the vial is avoided.

  However, in the closed drug delivery system described in Patent Document 1, since a flexible bag is used as the gas container, in order to store a predetermined amount of gas, a filler is disposed inside the bag. Need to be improved, and improvement is desired.

  Therefore, the present invention is a closed type that can easily extract a drug-containing liquid while avoiding negative pressure in the vial when extracting a drug-containing liquid from the vial by a simple configuration. It aims at providing a drug delivery system.

  In order to achieve such an object, it is considered that the gas container is a container having a volume having a predetermined amount of gas and an opening, and the opening of the container is closed by a flexible member. Be

  According to the closed drug delivery system having a configuration in which the opening of the container is closed by a flexible member, when the drug solution is injected into the vial as described above, the inside of the vial is The gas is evacuated into the container. At this time, the flexible member is formed with the gas in the vial by the container and the flexible member by extending outward of the container according to the volume of the gas to be evacuated. It can be housed in space. On the other hand, when extracting the liquid containing the drug from the vial as described above, the gas in the container is supplied into the vial, so that the negative pressure in the vial is avoided. it can.

  However, in a closed drug delivery system having a configuration in which the opening of the container is closed by a flexible member, the liquid containing the drug is extracted and the gas in the container is supplied into the vial. There is a disadvantage that the flexible member may be aspirated into the container to close the second passage connecting the inside of the vial and the container. When the second passage is blocked by the flexible member, the gas in the container can not be supplied into the vial, and the inside of the vial becomes negative as the liquid containing the drug is extracted. It can not be avoided that it is pressure.

  Therefore, in the closed drug delivery system of the present invention, a hollow needle member to be pierced by a rubber plug for sealing the opening of the vial, and the hollow needle member to open the opening of the vial A vial adapter comprising a plurality of gripping members for gripping the vial when pierced by the part, and connecting the vial adapter and the medical instrument via a first path provided in the hollow needle member A hollow cylindrical connecting member in communication with the inside of the vial, and a container whose open end is closed by a flexible member and in communication with the inside of the vial via a second path provided in the hollow needle member And, when injecting a drug solution into the vial through the first path in a state of being shielded from the outside air, the gas in the vial is evacuated into the container through the second path. , From the vial via the first path In the closed drug delivery system for supplying the gas stored in the container into the vial via the second channel when extracting the body, around the opening of the second channel to the container Preferably, the flexible member is provided with a rib capable of permitting the flow of gas between the container and the second passage while avoiding the closure of the second passage by the flexible member.

  In the closed drug delivery system of the present invention, first, the hollow needle member of the vial adapter is pierced by the vial and the vial is gripped by the gripping member, the connecting member such as a syringe By connecting a medical device, a medical fluid is injected from the medical device into the vial via the connection member and the first path while being shielded from the outside air. At this time, in the closed drug delivery system of the present invention, the gas in the vial is retracted into the container through the second path according to the injection of the drug solution, and the container is open at the flexible end It is closed by a member. Thus, according to the closed drug delivery system of the present invention, the flexible member is stretched outward of the container depending on the volume of gas evacuated into the container, and the gas is expanded with the container. It can be accommodated in the space formed by the flexible member.

  On the other hand, when liquid is extracted from the vial by the medical device through the connection member and the first path in a state of being shielded from the outside air as described above, the gas stored in the container Can be supplied into the vial via the second path to avoid negative pressure in the vial.

  When the liquid is extracted and the gas stored in the container is supplied into the vial, the flexible member is sucked into the container. However, according to the closed drug delivery system of the present invention, since the rib is provided around the opening of the second path to the container, the flexible member is obstructed by the rib and the first member There is no blockage of the two routes. Further, since the rib is configured to allow the flow of gas between the container and the second path, the gas in the container can be introduced into the vial via the second path. Can be supplied.

  Thus, according to the closed drug delivery system of the present invention, a rib capable of permitting gas flow between the container and the second passage is provided around the opening of the second passage to the container. Due to the simple constitution of being provided, it is possible to easily extract the liquid while avoiding the negative pressure in the vial when extracting the liquid from the vial.

  In the closed drug delivery system of the present invention, a plurality of the ribs are provided, for example, around the opening of the second path to the container, and each rib can allow gas to flow between the adjacent ribs. A gap may be provided. In addition, it comprises a cylindrical body surrounding the periphery of the opening of the second path with respect to the container, the cylindrical body being in communication with the inside and the outside, and provided with at least one hole through which gas can flow. You can also

  Also, in the closed drug delivery system of the present invention, in place of the rib, around the opening of the second passage to the container, the closure of the second passage by the flexible member is avoided. It may be configured to include at least one groove portion that can allow gas flow between the container and the second path. According to the groove portion, the same function and effect as the rib can be obtained.

BRIEF DESCRIPTION OF THE DRAWINGS The perspective view which shows one structural example of the closed type drug delivery system of this invention. The longitudinal cross-sectional view of FIG. The perspective view which shows the 1st form in the state which removed the cap of the closed type drug delivery system shown in FIG. The perspective view which shows the 2nd form in the state which removed the cap of the closed type drug delivery system shown in FIG. The perspective view which shows the other structural example of the closed type drug delivery system of this invention. The longitudinal cross-sectional view of FIG.

  Next, embodiments of the present invention will be described in more detail with reference to the attached drawings.

  As shown in FIG. 1, the closed drug delivery system 1 of the present embodiment is a connecting member for connecting the vial adapter 3 connected to the vial 2 and the vial adapter 3 and a medical device such as a syringe not shown. A female connector 4 and a container 5 for reserving gas in the vial 2 when injecting a drug solution into the vial 2 and storing gas to be supplied into the vial 2 when extracting liquid from the vial 2 , A flexible member 6 for closing the open end of the container 5 and a cap 7 for protecting the flexible member 6.

  As shown in FIG. 2, the vial adapter 3 punctures a hollow cylindrical main connection portion 31 and a septum (rubber stopper) 21 which protrudes from the lower end portion of the main connection portion 31 and seals the opening of the vial 2. A hollow needle member 32 is provided, a pair of arm members 33 extending in the outer peripheral direction from the lower end portion of the main connection portion 31, and a gripping member 34 depending from the end portion of the arm member 33. The main connection portion 31 of the vial adapter 3, the hollow needle member 32, the arm member 33, and the gripping member 34 are integrally formed of an elastic synthetic resin.

  The main connection portion 31 includes a hollow portion 311 into which the female connector 4 is inserted, and a hollow cylindrical container connection portion 312 which extends from the outer peripheral surface in the horizontal direction and is connected to the container 5. The hollow portion 311 is provided with a tapered surface which gradually increases in diameter from the tip end side to the opening end on the inner peripheral surface. In addition, the container connection portion 312 is provided with a tapered surface whose inner peripheral surface is gradually enlarged in diameter from the main connection portion 31 side toward the opening end. Further, the main connection portion 31 is provided with a pair of projecting portions 313 projecting outward from the open end of the hollow portion 311.

  The hollow needle member 32 is provided with a sharp needle point portion 321 at the tip end, and is provided with a first path 322 and a second path 323 opened in the needle point portion 321. The first path 322 communicates with the hollow portion 311 of the main connection portion 31, and the second path 323 communicates with the inside of the container connection portion 312.

  The gripping member 34 is provided with a window 341 between the tip end and the base end, and when the tip end is pressed against the neck 22 of the vial 2, it extends from the mouth of the vial 2 to the outer peripheral side The projecting flange portion 23 is accommodated in the window portion 341. In addition, the gripping member 34 is provided with an arc-shaped recess 342 at the tip, and the recess 342 is in pressure contact with the neck 22 of the vial 2.

  The female connector 4 includes a hollow cylindrical inner sleeve 41, and an outer sleeve 42 disposed on the outer circumferential side of the inner sleeve 41 and connected to the inner sleeve 41 at its base end. It has a female screw portion 43 in which the projection 313 of the main connection portion 31 is screwed to the surface. The outer peripheral surface of the inner sleeve tube 41 is a tapered surface whose diameter is gradually reduced from the proximal end toward the distal end, and is fitted to the inner peripheral surface of the hollow portion 311.

  The inner sleeve 41 extends further to the proximal end side from the portion connected to the outer sleeve 42 and is connected to the hollow cylindrical valve seat member 44. The valve seat member 44 is provided with a valve body 45 at its base end, and the valve body 45 has a slit 46 at its central portion. The valve body 45 is made of a soft resin, and is opened by inserting a medical device such as a syringe into the slit 46 and closed by being removed.

  The container 5 is made of a hard resin and has a hemispherical container body 51, a hollow cylindrical connecting cylinder 52 projecting from the bottom of the container body 51 in the direction of the vial adapter 3, and a connecting cylinder 52 to the bottom of the container body 51. And a plurality of ribs 53 erected around the opening of the. The container main body 51 is provided with an open end on the side facing the connection cylindrical portion 52, and the open end is closed by a flexible member 6 made of a soft resin. The outer peripheral surface of the connection cylindrical portion 52 is a tapered surface which is gradually reduced in diameter from the container main body 51 side to the vial adapter 3 side, and is fitted to the inner peripheral surface of the container connection portion 312. As a result, the connection cylindrical portion 52 communicates with the second path 323 of the hollow needle member 32, and constitutes a part of the second path 323.

  Further, as shown in a state in which the cap 7 is removed in FIG. 3, the rib 53 is a circle along a virtual circle surrounding the periphery of the opening of the connection cylindrical portion 52 (second path 323) with respect to the bottom of the container body 51. It has an arc-like shape and is provided with a gap 54 allowing gas to flow between adjacent ribs 53.

  In the present embodiment, the rib 53 has the above-described arc shape, but if the rib 53 is disposed along a virtual circle surrounding the connection cylinder 52, the arc shown in FIG. 3 is reversed. The shape may be a flat shape, and the shape is not particularly limited.

  Next, the operation of the closed drug delivery system 1 of the present embodiment will be described.

  In the closed drug delivery system 1, in use, the cap 7 is first removed and the flexible member 6 is exposed. Next, the hollow needle member 32 of the vial adapter 3 is punctured into the septum 21 of the vial 2. In this case, the gripping member 34 abuts on the flange portion 23 of the vial 2 as the hollow needle member 32 is pushed in, but the gripping member 34 is expanded in the outer peripheral direction by its own elasticity and runs over the flange portion 23 Then, it is pressed against the neck portion 22 of the vial 2 to grip the vial 2.

  Next, in a state where the vial 2 is gripped by the gripping member 34, a medical instrument such as a syringe (not shown) is connected to the female connector 4, and a first path of the female connector 4 and the hollow needle member 32 from the medical instrument. A chemical solution such as physiological saline is injected into the vial 2 via 322, and a drug such as an anticancer drug contained in the vial 2 is diluted with the drug solution or dissolved in the drug solution. Thus, the preparation of the liquid comprising the medicament actually administered to the patient is carried out.

  At this time, a gas such as air coexists in the vial 2 in addition to the drug, but when the gas in the vial 2 is narrowed by the injection of the drug, the gas of the hollow needle member 32 The container main body 51 of the container 5 is retracted via the second path 323. Since a predetermined volume of gas is stored in advance in the container main body 51, when the gas in the vial 2 is introduced, the flexible member 6 is like the flexible member 6a shown by an imaginary line in FIG. To the outside of the container body 51. As a result, the gas in the vial 2 is accommodated in the space formed by the container body 51 and the expanded flexible member 6a.

  Next, when extracting a liquid containing the medicine from the vial 2, the vial 2 is held up and down by the holding member 34 and vertically reversed to connect the vial 2 to the female connector 4. The liquid or the like is extracted by a medical instrument such as the syringe. Thus, when the liquid or the like is extracted, the gas stored in the container body 51 is supplied into the vial 2 through the second passage 323 of the hollow needle member 32, and the gas in the container body 51 is reduced. Accordingly, the flexible member 6 is sucked toward the connection tube 52 (the second path 323).

  Here, in the case where the container body 51 is not provided with the rib 53, the flexible member 6 is in close contact with the opening of the connection cylindrical portion 52 like the flexible member 6b shown by a phantom line in FIG. Close this up. As a result, the gas stored in the container main body 51 can not be supplied into the vial 2 through the second path 323 of the hollow needle member 32, and the inside of the vial 2 becomes negative pressure, so that It becomes difficult to extract the liquid containing the drug.

  However, in the closed type drug delivery system 1 of the present embodiment, since the container body 51 is provided with the rib 53, the flexible member 6 is a rib 53 like the flexible member 6c shown by a phantom line in FIG. Therefore, the opening of the connecting cylinder 52 is not blocked. Further, at this time, the gas stored in the container main body 51 can flow into the connection cylindrical portion 52 from the gap 54 of the rib 53, and the inside of the vial 2 via the second passage 323 of the hollow needle member 32. Can be supplied.

  In the present embodiment, a plurality of ribs 53 are disposed along a virtual circle surrounding the periphery of the opening of the connection cylinder 52 with respect to the bottom of the container main body 51 with a gap 54 between the ribs 53 adjacent thereto. However, as shown in FIG. 4, a cylindrical rib 55 is provided to surround the periphery of the opening of the connecting cylindrical portion 52 relative to the bottom of the container body 51, and the rib 55 communicates with the inside and the outside Alternatively, at least one hole 56 may be provided to allow the flow of the fluid.

  According to the configuration shown in FIG. 4, the flexible member 6 is not obstructed by the rib 55 and does not block the opening of the connecting cylindrical portion 52 when extracting the liquid containing the medicine or the like from the vial 2. The gas stored in the container main body 51 can flow into the connection cylindrical portion 52 from the hole 56 provided in the rib 55, and the inside of the vial 2 via the second path 323 of the hollow needle member 32. Can be supplied.

  In the present embodiment, although the rib 55 has a cylindrical shape, the rib 55 may have a cylindrical shape surrounding the opening of the connection cylindrical portion 52. For example, a polygonal shape such as a rectangular cylindrical shape or a pentagonal cylindrical shape It may be cylindrical.

  Further, as shown in FIG. 5, in the closed drug delivery system 1 of the present embodiment, in place of the ribs 53 and 55, the closure by the flexible member 6 is avoided, and the container body 51 and the connection cylindrical portion 52 are separated. The groove 57 may be provided to allow the flow of gas therebetween.

  In the present embodiment, a plurality of grooves 57 extending from the container body 51 to the connection cylinder 52 are provided radially around the connection cylinder 52, but at least one groove 57 may be provided. There is no particular limitation.

  In the closed type drug delivery system 1, as shown by the phantom line in FIG. 6, even if the flexible member 6b sucked in the direction of the connecting cylinder 52 closely contacts the opening of the connecting cylinder 52, the container 57 The flow of gas between the main body 51 and the connection cylinder 52 can be secured, and the gas stored in the container body 51 is transferred from the connection cylinder 52 to the vial via the second path 323 of the hollow needle member 32. It can be supplied into the bottle 2.

  DESCRIPTION OF SYMBOLS 1 ... closed type drug transfer system, 2 ... vial, 3 ... vial adapter, 4 ... female connector (connection member), 5 ... container, 6 ... flexible member, 32 ... hollow needle member, 53, 55 ... rib, 54 ... gap, 56 ... hole, 322 ... first path, 323 ... second path.

Claims (4)

And a plurality of holding members for holding the vial when the hollow needle member is pierced by the opening of the vial. A vial adapter,
A hollow cylindrical connecting member connecting the vial adapter and the medical device and communicating with the inside of the vial via a first path provided in the hollow needle member;
A container whose open end is closed by a flexible member and which communicates with the inside of the vial via a second passage provided in the hollow needle member;
While injecting the drug solution into the vial through the first path in a state of being shielded from the outside air, the gas in the vial is retracted into the container through the second path, while the first A closed drug delivery system for feeding the gas stored in the container into the vial through the second route when extracting liquid from the vial through the route of
Allows gas flow between the container and the second passage around the opening of the second passage to the container, avoiding the closure of the second passage by the flexible member Closed drug delivery system characterized by comprising   The closed drug delivery system according to claim 1, wherein a plurality of the ribs are provided around the opening of the second path to the container, and each rib can flow a gas between it and an adjacent rib. A closed drug delivery system comprising a gap.   The closed drug delivery system according to claim 1, wherein the rib comprises a cylindrical body surrounding the periphery of the opening of the second path to the container, the cylindrical body communicating with the inside and the outside, and a gas A closed drug delivery system comprising at least one hole capable of circulating the And a plurality of holding members for holding the vial when the hollow needle member is pierced by the opening of the vial. A vial adapter,
A hollow cylindrical connecting member connecting the vial adapter and the medical device and communicating with the inside of the vial via a first path provided in the hollow needle member;
A container whose open end is closed by a flexible member and which communicates with the inside of the vial via a second passage provided in the hollow needle member;
While injecting the drug solution into the vial through the first path in a state of being shielded from the outside air, the gas in the vial is retracted into the container through the second path, while the first A closed drug delivery system for feeding the gas stored in the container into the vial through the second route when extracting liquid from the vial through the route of
Allows gas flow between the container and the second passage around the opening of the second passage to the container, avoiding the closure of the second passage by the flexible member A closed drug delivery system comprising at least one groove.