WO2019026796A1

WO2019026796A1 - Adaptor assembly

Info

Publication number: WO2019026796A1
Application number: PCT/JP2018/028275
Authority: WO
Inventors: 野口央照; 沖山忠
Original assignee: 株式会社ジェイ・エム・エス
Priority date: 2017-08-03
Filing date: 2018-07-27
Publication date: 2019-02-07
Also published as: JP2019025246A; JP6972747B2

Abstract

An adaptor assembly (1) is provided with: an adaptor (10) capable of being mounted to vial (80); and a cover (50) separably mounted to the adaptor from above. The adaptor is provided with: a puncture needle (11) capable of puncturing the plug body (87) of the vial; a plurality of latches (30) capable of engaging with the increased diameter flange (83) of the vial; and a plurality of arms (20) which have the plurality of latches provided thereto and which are elastically bendable and deformable. The cover is provided with a guide mechanism (59) extending so as to face the puncture needle. The guide mechanism extends further downward than the puncture needle while the cover is mounted to the adaptor.

Description

Adapter assembly

The present invention relates to an adapter assembly comprising a vial mountable adapter and a cover separably mounted on the adapter.

A vial containing a powdered drug is widely distributed. When a drug is administered to a patient, a solution is injected into the vial, the drug is dissolved in the solution to obtain a drug solution, and the drug solution is removed from the vial. The injection of the solution into the vial and the removal of the drug solution are performed via a puncture needle (sometimes called a "bottle needle") pierced in a stopper (rubber stopper) that seals the opening (opening) of the vial.

When the drug is a dangerous drug such as an anticancer drug, for example, it is necessary to prevent such drug and its drug solution from leaking out to the outside. Therefore, in order to prevent the puncture needle punctured in the stopper of the vial from coming out of the stopper unintentionally, the claw engaging with the enlarged flange surrounding the mouth of the vial is integrally provided with the puncture needle Adapters are often used.

An example of such an adapter is described in US Pat. The adapter of Patent Document 1 includes a puncture needle and a claw that can be engaged with a flange of a vial. The claws are provided on an elastically bendable arm. With the tip of the puncture needle facing the stopper of the vial, the adapter is pushed toward the vial. The puncture needle punctures the stopper of the vial. The claw is displaced in a direction away from the puncture needle (i.e., radially outward) by abutting on the stopper (or the aluminum cap covering it), and the arm elastically bends and deforms. Thereafter, as the pawl passes the flange, the arm resiliently recovers and the pawl engages the flange of the vial.

WO 2016/152801 (FIGS. 9A to 11B)

When attaching the adapter to the vial, after visually aligning the tip of the puncture needle with the center of the stopper so that the puncture needle punctures the center of the stopper, the adapter is pushed toward the vial. However, in practice, the tip of the puncture needle may be off center of the plug. When the puncture needle punctures the off center of the stopper, the adapter can not be properly attached to the vial, such as it becomes difficult to engage the hook of the adapter with the flange of the vial.

An object of the present invention is to align the tip of the puncture needle of the adapter with the center of the stopper of the vial.

The adapter assembly of the present invention comprises an adapter mountable to a vial, and a cover removably mounted on the adapter from above. The adapter is provided with a puncture needle capable of piercing the stopper of the vial, a plurality of claws engageable with the enlarged flange of the vial, and a plurality of elastically bendable plurality provided with the plurality of claws. And the arm of the The cover includes a guide mechanism extending to face the puncture needle. When the cover is attached to the adapter, the guide mechanism extends further downward than the puncture needle.

According to the present invention, in the state where the cover is attached to the adapter, the guide mechanism provided on the cover extends further downward than the puncture needle. Therefore, the tip of the puncture needle can be easily aligned with the center of the plug using the guide mechanism.

FIG. 1 is an exploded perspective view of an adapter assembly and a vial according to one embodiment of the present invention. FIG. 2A is a top perspective view of an adapter according to an embodiment of the present invention. FIG. 2B is a perspective view from below of the adapter according to an embodiment of the present invention. FIG. 2C is a cross-sectional view along a plane including the central axis of the adapter according to one embodiment of the present invention. FIG. 3A is a bottom perspective view of a cover according to an embodiment of the present invention. FIG. 3B is a cross-sectional perspective view from below of the cover according to an embodiment of the present invention. FIG. 3C is a plan view of a cover according to an embodiment of the present invention. FIG. 4A is a top perspective view of an adapter assembly according to one embodiment of the present invention. FIG. 4B is a plan view of an adapter assembly in accordance with one embodiment of the present invention. FIG. 4C is a cross-sectional view of the adapter assembly according to an embodiment of the present invention along a plane including the central axis. FIG. 4D is a cross-sectional view of an adapter assembly according to an embodiment of the present invention taken along another plane including the central axis. FIG. 5 is a cross-sectional view of a vial to which an adapter assembly according to an embodiment of the present invention is attached. FIG. 6 is a perspective view showing a state immediately before the puncture needle of the adapter assembly according to an embodiment of the present invention punctures the stopper of the vial. FIG. 7 is a perspective view showing the adapter assembly according to an embodiment of the present invention attached to a vial.

In the above-mentioned adapter assembly of the present invention, the cover may include a plurality of the guide mechanisms. The plurality of guide mechanisms may be disposed along a circle concentric with the puncture needle. According to this aspect, it is possible to improve the accuracy of the alignment of the tip of the puncture needle with respect to the center of the plug.

The guide mechanism may be elastically deformable such that its tip is separated from the puncture needle. According to this aspect, the adapter assembly can be adapted to a plurality of types of vials in which the outer diameter of the stopper (or flange) is different. Also, even if the guide mechanism collides with the shoulder of the vial in the process of attaching the adapter assembly to the vial, the puncture needle can be pierced to the desired depth to the stopper.

The adapter may include a connector in communication with the puncture needle. The cover may include a connector case for housing the connector. According to this aspect, the sanitary condition of the connector can be well maintained. Also, by attaching a cover to a used adapter, the potential for drug exposure can be reduced.

The connector case may be disposed on the top of the cover. According to this aspect, when holding the cover, the worker is likely to pick the connector case with his / her finger. This causes the operator to apply a downward force to the arm when attaching the adapter assembly to the vial, which makes it difficult to attach the adapter assembly to the vial or causes the arm to break (break). Reduce the possibility of the situation happening.

The peripheral wall of the connector case may be provided with a pair of gripping surfaces parallel to each other. According to this aspect, when holding the adapter assembly, the worker is always directed to pinch the gripping surface. This further reduces the possibility of the operator applying a downward force on the arm when attaching the adapter assembly to the vial.

An extension plate may project radially outward from the lower end of the peripheral wall of the connector case. According to this aspect, when attaching the adapter assembly to the vial, the operator can apply a downward force to the expansion plate. The expansion plate also prevents an operator's finger from touching the arm and inadvertently applying a downward force to the arm when attaching the adapter assembly to the vial.

The extension plate may have a major axis in a direction in which the pair of gripping surfaces face each other. Such an aspect further facilitates gripping the gripping surface with a finger to apply a downward force to the adapter assembly.

The extension plate may be located higher than the plurality of arms. Such an aspect is advantageous for reducing the possibility of the operator's finger touching the arm and inadvertently applying a downward force to the arm when attaching the adapter assembly to the vial.

The plurality of arms may be disposed to face in a first direction orthogonal to the longitudinal direction of the puncture needle. In this case, the pair of gripping surfaces may be arranged to face in a second direction orthogonal to the first direction and perpendicular to the longitudinal direction of the puncture needle. Such an aspect is advantageous for reducing the possibility that a finger other than the pinched finger may touch the arm and inadvertently apply a downward force to the arm when attaching the adapter assembly to the vial. is there.

An alignment structure may be provided on the cover to axially align the cover coaxially with the adapter. According to this aspect, it is possible to improve the accuracy of the alignment of the tip of the puncture needle with respect to the center of the plug.

An engagement structure may be provided on the cover to engage the adapter so as to prevent the adapter from falling off the cover. According to this aspect, the mounting operation of the adapter assembly to the vial can be easily performed.

Hereinafter, the present invention will be described in detail with reference to preferred embodiments. However, it goes without saying that the present invention is not limited to the following embodiments. Each drawing referred to in the following description is a simplified view of main members constituting an embodiment of the present invention for convenience of explanation. Therefore, within the scope of the present invention, any member not shown in the drawings may be added, or any member shown in the drawings may be changed or omitted.

FIG. 1 is an exploded perspective view of an adapter assembly 1 and a vial 80 according to an embodiment of the present invention. The adapter assembly 1 includes an adapter 10 attached to a vial 80 and a cover 50 that can be repeatedly attached to and detached from the adapter 10. For convenience of the following description, an XYZ orthogonal coordinate system as illustrated is set. The Z-axis is parallel to the central axis 1a of the adapter assembly 1 (see FIG. 2C described below; the central axis 1a coincides with the central axes of the adapter 10, the cover 50, and the vial 80). The direction parallel to the Z axis is called "vertical direction". The side to which the Z-axis arrow points is called the "upper" side, and the opposite side is called the "lower" side. The direction parallel to the plane (that is, the XY plane) orthogonal to the Z axis is called "horizontal direction". The direction along the straight line orthogonal to the central axis 1a is called "radial direction", and the direction rotating around the central axis 1a is called "circumferential direction".

1. Adapter FIG. 2A is a perspective view from above of the adapter 10. FIG. 2B is a perspective view of the adapter 10 as viewed from below. FIG. 2C is a cross-sectional view along a plane including the central axis 1 a of the adapter 10. The adapter 10 is substantially the same as the adapter described in Patent Document 1.

As shown in FIG. 2C, the adapter 10 includes a puncture needle (male member) 11 extending along the central axis 1a. The puncture needle 11 is provided with a sharp tip 11 a at its lower end. Inside the puncture needle 11, a flow path 12 through which a liquid (for example, a drug solution) flows is formed along the central axis 1a. The flow channel 12 communicates with an opening 13 provided on the outer peripheral surface near the tip 11 a of the puncture needle 11. The opening 13 opens radially outward.

The tubular portion 14 surrounds a portion near the proximal end 11 b of the puncture needle 11. The tubular portion 14 has a hollow cylindrical shape, and is coaxially disposed with the puncture needle 11 and radially spaced from the puncture needle 11. The upper end of the tubular portion 14 is connected to the proximal end 11 b of the puncture needle 11.

As shown in FIG. 2A, at the lower end of the tubular portion 14, a pair of arms 20 is provided. The pair of arms 20 are opposed in the X-axis direction. Each arm 20 includes a shoulder 21 extending substantially parallel to the X axis, and a suspension 22 extending downward from the distal end (the end farthest from the puncture needle 1) of the shoulder 21. The suspension 22 faces the puncture needle 11. The suspension portion 22 is inclined so as to approach the puncture needle 11 as it approaches its lower end.

A claw 30 is provided at the lower end of the suspension 22 so as to protrude toward the puncture needle 11. The shoulder portion 21 and the suspension portion 22 constituting the arm 20, and the claw 30 are thin plates having a substantially constant dimension in the Y-axis direction. Each pawl 30 includes two ribs 33 extending downwardly from its lower surface. The rib 33 is a thin plate substantially parallel to the XZ plane. The two ribs 33 provided on each of the claws 30 are separated in the Y-axis direction. The rib 33 has an end edge 33a extending downward starting from the tip end of the claw 30 (the portion of the claw 30 closest to the puncture needle 11) 30a. The edge 33a is configured by a smooth convex curve. Viewed as a whole, the edge 33a is inclined away from the puncture needle 11 downward from the tip 30a.

The vertical position of the lower end 30 b of the claw 30 (or the rib 33) is not limited, but is preferably the same as or slightly lower than the tip 11 a of the puncture needle 11. This is because the adapter 10 can be stably left on the horizontal surface in the upright state with the claw 30 down.

In the present embodiment, each rib 30 is provided with two ribs 33. However, each claw 30 may be provided with one or more ribs 33. The dimension of the rib 33 in the Y-axis direction is arbitrary. For example, the rib 33 may have a dimension in the Y-axis direction substantially the same as that of the claw 30.

The arm 20 has a cantilever support structure having a fixed end connected to the tubular portion 14. The shoulder 21 constituting the arm 20 is a thin plate-like member, and can be elastically bent and deformed relatively easily. The pawl 30 is provided at the free end of the arm 20. Therefore, the arm 20 can be elastically deformed in the direction in which the nail 30 is separated from the puncture needle 11. When the arm 20 deforms in this manner, the shoulder 21 bends so that the distal end of the shoulder 21 is displaced upward.

From the lower end of the tubular portion 14, an arc-shaped hook portion 16 further protrudes radially outward. The collar 16 is continuous with the shoulder 21 so as to form a substantially flat surface with the shoulder 21 of the arm 20.

In the present embodiment, the arm 20 and the hook portion 16 are integrated with the puncture needle 11 via the tubular portion 14, but the present invention is not limited thereto. For example, the tubular portion 14 may be omitted, and the shoulder 21 and the hook 16 of the arm 20 may be provided directly on the puncture needle 11.

A connector 40 is provided above the tubular portion 14. As shown in FIG. 2C, the connector 40 includes a cylindrical portion 41 having a substantially cylindrical shape, and a partition member (sometimes called "septum") 45 provided on the upper end of the cylindrical portion 41; And a cap 47 covered on the partition member 45. The lumen 42 of the cylindrical portion 41 communicates with the flow passage 12 in the puncture needle 11.

The partition member 45 is a thin plate having a circular plan view shape. At the center of the partition member 45, a linear slit (cut) 45a penetrating the partition member 45 in the vertical direction is formed. The partition member 45 can be easily deformed by an external force, and returns immediately to the state before deformation when the external force is removed.

The outer peripheral surface of the cylindrical portion 41 is a cylindrical surface. A pair of engagement protrusions 41 a and an annular protrusion 41 b protrude outward from the outer peripheral surface of the cylindrical portion 41. The annular protrusion 41 b is continuous in the circumferential direction and slightly spaced downward from the engagement protrusion 41 a.

The cap 47 includes a top plate 48 having a disk shape, and a circumferential wall 49 having a cylindrical shape extending from the outer peripheral edge of the top plate 48. A circular opening (through hole) 48 a is formed at the center of the top plate 48. The surrounding wall 49 is formed with a pair of engagement holes 49a. The engagement holes 49 a are through holes radially penetrating the surrounding wall 49.

The partition member 45 is held by the upper end of the cylindrical portion 41 and the top plate 48 of the cap 47 in the thickness direction (that is, in the vertical direction). The cap 47 is engaged with the engaging protrusion 41 a by fitting the engaging protrusion 41 a protruding from the cylindrical portion 41 into the engaging hole 49 a of the cap 47. The slit 45a of the partition member 45 is exposed in the opening 48a formed in the top plate 48 of the cap 47 (see FIG. 2A). The annular protrusion 41 b formed in the cylindrical portion 41 is adjacent to the lower side of the peripheral wall 49 of the cap 47. The top surface of the annular protrusion 41 b constitutes a cylindrical surface substantially the same as the outer peripheral surface of the peripheral wall 49.

The connector 40 provided with the partition member 45 in which the slit 45a is formed is generally called a needleless port. In the initial state in which the partition member 45 is not deformed, the slit 45a is closed to form a fluid-tight seal. The partition member 45 has a function of separating the inner cavity 42 of the cylindrical portion 41 from the outside. When a cylindrical male luer (not shown) having no sharp tip is inserted into the slit 45 a of the partition wall member 45, the partition wall member 45 is elastically deformed and the lumen 42 of the cylindrical portion 41 and the male luer communicate. When the male luer is pulled out of the partition member 45, the partition member 45 immediately returns to the initial state, and the slit 45a is closed in a fluid tight manner. Thus, the partition member 45 functions as a self-closing valve body.

The portion of the adapter 10 excluding the partition wall member 45 and the cap 47 is preferably integrally manufactured as a whole by injection molding a resin material. Resin materials that can be used include, but are not limited to, polyethylene, polypropylene, polycarbonate, styrene ethylene, polyethylene terephthalate, polybutylene terephthalate, butylene styrene block copolymer, etc. In consideration of elastic bending deformation of 20, polyolefin resins such as polyethylene and polypropylene are preferable. The material of the cap 47 is not limited, but is preferably a hard material, and for example, resin materials such as polycarbonate, polypropylene, polyacetal, polyamide, hard polyvinyl chloride, polyethylene and the like can be used. The material of the partition member 45 is not limited, but is preferably a soft material (so-called elastomer) having rubber elasticity (or flexibility), for example, a rubber material such as isoprene rubber, silicone rubber, butyl rubber, or the like A thermoplastic elastomer etc. can be used.

2. Cover FIG. 3A is a perspective view of the cover 50 as viewed from below. FIG. 3B is a cross-sectional perspective view of the cover 50 as viewed from below. FIG. 3C is a plan view of the cover 50. FIG.

The cover 50 includes a connector case 51, an expansion plate 58, and a guide bar 59 (see FIG. 1).

As shown in FIG. 3A, the connector case 51 has a hollow, substantially cylindrical shape, with its upper end closed and its lower end released. As described later, the connector 40 (see FIGS. 4C and 4D) is accommodated in the connector case 51 from below. A pair of gripping surfaces 53 parallel to each other is provided on the outer peripheral surface of the peripheral wall 52 extending along the vertical direction of the connector case 51 (only one gripping surface 53 is visible in FIG. 3A). The gripping surface 53 is substantially flat and parallel to the XZ plane. The outer peripheral surface of the peripheral wall 52 excluding the gripping surface 53 is not limited, but in the present embodiment, it is a smooth convex curved surface (for example, a cylindrical surface) (see FIG. 3C).

As shown in FIG. 3B, the extension wall 55 protrudes downward from the extension plate 58. The extension wall 55 extends the surrounding wall 52 downward beyond the extension plate 58. However, unlike the surrounding wall 52, the extending wall 55 is not annularly continuous in the circumferential direction, and is divided at two places. That is, the pair of extension walls 55 oppose each other in the Y-axis direction.

Four ribs (protrusions) 56 project from the inner peripheral surface of the connector case 51 (only two ribs 56 are shown in FIG. 3B). The ribs 56 extend from the circumferential wall 52 to the extension wall 55 along the up-down direction (i.e., the Z-axis direction). The four ribs 56 are arranged at equal angular intervals with respect to the central axis. The diameter of the circle inscribed in the four ribs 56 (this circle is along the XY plane) is substantially the same as the outer diameter of the peripheral wall 49 of the cap 47 and the annular projection 41b (see FIG. 2A). From the two ribs 56 opposed to each other across the central axis among the four ribs 56, a protrusion 57 protrudes toward the central axis. In the present invention, the number of ribs 56 is not limited to four, and may be three or five or more. The projections 57 may be provided on all the ribs 56.

An extension plate 58 extends radially outward from the lower end of the peripheral wall 52 of the connector case 51. The upper surface of the expansion plate 58 is substantially parallel to the horizontal plane (XY plane). As shown in FIG. 3C, the expansion plate 58 is annularly continuous around the connector case 51. The plan view shape of the outer peripheral edge of the expansion plate 58 is non-circular in which the dimension along the Y-axis direction is larger than the dimension along the X-axis direction. Specifically, the expansion plate 58 of the present embodiment is an athletic stadium that is composed of two straight lines 58a parallel to the Y-axis direction and two arcs 58b connecting both ends of the two straight lines. It has a shape similar to a track. In other words, the expansion plate 58 has a shape in which a circle concentric with the central axis of the cover 50 is cut by two parallel straight lines 58a. As a result, the radial extension length of the expansion plate 58 from the peripheral wall 52 of the connector case 51 is longer in the Y-axis direction than in the X-axis direction. Since the outer peripheral edge of the expansion plate 58 includes two parallel straight lines 58a, a large number of covers 50 can be arranged at high density in the horizontal and vertical directions on the horizontal plane with the connector case 51 facing up. . This facilitates handling of the cover 50, for example, when mass producing the cover 50.

In addition, the planar view shape of the expansion board 58 is not limited to this embodiment. The extension plate 58 may have an arbitrary planar view shape such as, for example, an oval, an oval, a substantially rhombic, or a polygon (for example, a hexagon or an octagon). However, as in the present embodiment, the expansion plate 58 preferably has a major axis in the Y-axis direction. The extension plate 58 may not be continuous in the circumferential direction. For example, in FIG. 3C, two straight lines 58 a may be in contact with the surrounding wall 52. In this case, the extension length of the expansion plate 58 from the surrounding wall 52 along the X-axis direction is zero.

As shown in FIG. 3A, a plurality of (four in this embodiment) guide bars 59 extend downward from the outer peripheral edge (in particular, the arc 58b) of the expansion plate 58. As shown in FIG. The guide bar 59 has a narrow thin-plate shape, and can be elastically bent and deformed so that its tip (or lower end) 59a approaches and separates from the central axis. When viewed along the Z-axis, the undeformed initial guide bar 59 is disposed on a circle concentric with the cover 50.

The cover 50 is preferably integrally manufactured as a whole by injection molding a resin material. Resin materials which can be used include, but are not limited to, polyethylene, polypropylene, polycarbonate, styrene ethylene, polyethylene terephthalate, polybutylene terephthalate, butylene styrene block copolymer and the like. In consideration of elastic bending deformation of the guide bar 59, polyolefin resins such as polyethylene and polypropylene are preferable.

3. Adapter Assembly As shown in FIG. 1, the cover 50 can be attached to the adapter 10 from above. FIG. 4A is a perspective view of the adapter assembly 1 with the cover 50 attached to the adapter 10 as viewed from above. FIG. 4B is a plan view of the adapter assembly 1. FIG. 4C is a cross-sectional view of the adapter assembly 1 along the XZ plane including the central axis. FIG. 4D is a cross-sectional view of the adapter assembly 1 along the YZ plane including the central axis.

As shown in FIGS. 4C and 4D, the connector 40 of the adapter 10 is housed in the connector case 51 of the cover 50. As shown in FIG. 4D, the lower end of the extension wall 55 of the cover 50 vertically abuts on the hook portion 16 (see FIG. 2A) of the adapter 10. Thereby, the insertion depth of the adapter 10 with respect to the connector case 51 is defined.

Although not shown, the rib 56 (see FIG. 3B) provided on the inner circumferential surface of the connector case 51 abuts on the circumferential wall 49 of the cap 47 and the annular projection 41b (see FIG. 2A). Thereby, the cover 50 is aligned coaxially with the adapter 10. Also, the projection 57 (see FIG. 3B) protruding from the rib 56 engages with the lower edge of the annular projection 41 b. This prevents the adapter 10 from falling out of the cover 50. In the process of attaching the cover 50 to the adapter 10, when the projection 57 passes over the annular projection 41b and engages with the annular projection 41b, the operator feels a click on the fingertip. The operator can recognize that the cover 50 is correctly attached to the adapter 10 by the click feeling.

When the cover 50 is attached to the adapter 10, the extension wall 55 and the projection 57 of the cover 50 vertically position the adapter 10 with respect to the cover 50. In this state, the guide bar 59 faces the puncture needle 11 and extends further downward than the puncture needle 11. That is, the tip 59 a of the guide bar 59 is located below the tip 11 a of the puncture needle 11. Also preferably, the guide bar 59 extends further downward than the claws 30 (including the rib 33). That is, the tip end 59 a of the guide bar 59 is preferably located below the lower end 30 b of the claw 30. As described above, since the cover 50 is coaxial with the adapter 10, the four guide bars 59 are arranged along a circle concentric with the puncture needle 11.

As shown in FIG. 4C, the cover 50 does not vertically abut on the arm 20 (particularly its shoulder 21). For this reason, the cover 50 attached to the adapter 10 does not inhibit the elastic deformation of the arm 20.

As shown in FIG. 4A, the expansion plate 58 of the cover 50 is at a higher position than the arm 20. The arms 20 (especially their shoulders 21) project radially outward of the expansion plate 58. The guide bar 59 extends further downward from the extension plate 58 beyond the arm 20. When the cover 50 is rotated relative to the adapter 10 about the central axis, the side edge 59 b (see FIG. 4A) extending along the vertical direction of the guide bar 59 is on the side edge defining the width of the arm 20 in the Y-axis direction. Limited by colliding. The pair of arms 20 are opposed in the X-axis direction, whereas the pair of gripping surfaces 53 of the cover 50 are opposed in the Y-axis direction, and the major axis of the expansion plate 58 of the cover 50 is parallel to the Y-axis It is.

The cover 50 can be repeatedly attached to and detached from the adapter 10. When the cover 50 is separated from the adapter 10, a relatively large tensile force is applied to the adapter 10 and the cover 50 in the vertical direction to release the engagement between the annular projection 41b of the adapter 10 and the projection 57 of the cover 50. There is a need to.

4. Method of Using Adapter Assembly FIG. 5 is a cross-sectional view of an example of a vial 80 to which the adapter assembly 1 is attached. The vial 80 is a sealed container in which a stopper (rubber stopper) 87 is inserted into a port (opening) 82 facing upward of the bottle body 81 to seal the port 82 airtightly and liquid tight. Powdered medicine (not shown) is contained in the vial 80. At the upper end of the bottle body 81, an enlarged flange 83 is provided so as to surround the opening 82. The outer peripheral surface of the flange 83 is a substantially cylindrical surface. The bottle body 81 has a neck portion 84 having an outer diameter smaller than the flange 83 downward from the flange 83, a shoulder 85 having an outer diameter gradually increasing downward, and an outer diameter substantially constant in the vertical direction Certain cylindrical portions 86 are provided adjacent to each other in this order.

The plug 87 has an outer diameter substantially the same as that of the flange 83. A cap 88 is attached to the plug 87 and the flange 83 in order to prevent the plug 87 from falling off the opening 82 of the bottle body 81. The cap 88 is made of a sheet of metal (for example, aluminum) or resin, and is in close contact with the stopper 87 and the flange 83. The lower end of the cap 88 extends below the outer peripheral surface which is a substantially cylindrical surface of the flange 83. The upper end of the cap 88 extends to the upper surface of the plug 87. The central region of the upper surface of the plug 87 is exposed to the outside through a circular opening 88 a provided in the cap 88 (see FIG. 6 described later).

The outer peripheral surface of the plug 87 and the outer peripheral surface of the flange 83 are cylindrical surfaces having substantially the same diameter. Accordingly, the outer peripheral surface 88 c of the cap 88 mounted on the plug 87 and the flange 83 is also a substantially cylindrical surface. The upper end of the outer peripheral surface 88c of the cap 88 (or the outer peripheral edge of the upper surface of the cap 88) is referred to as an upper end edge 88b, and the lower end of the outer peripheral surface 88c is referred to as a lower end edge 88d.

The vial 80 may not have the cap 88. In that case, the upper end edge 88 b, the lower end edge 88 d and the outer peripheral surface 88 c mean corresponding portions of the plug 87 or the flange 83.

The adapter assembly 1 is delivered to a medical institution such as a hospital with the cover 50 attached to the adapter 10 as shown in FIG. 4A. When preparing a drug solution using the drug in the vial 80, the adapter assembly 1 is attached to the vial 80 as follows.

First, as shown in FIG. 6, the vial 80 is erected with the stopper 87 up. The tip end 11a of the puncture needle 11 is brought close to the upper surface of the plug 87 while maintaining the adapter assembly 1 such that the central axis (or the puncture needle 11) is parallel in the vertical direction. As described above, the guide bar 59 of the cover 50 extends below the tip 11 a of the puncture needle 11 (the vial 80 side). Therefore, before the tip 11 a of the puncture needle 11 contacts the upper surface of the plug 87, a part of the cap 88 (or the plug 87) is stored in the area surrounded by the four guide bars 59. . The four guide bars 59 are arranged along a circle concentric with the puncture needle 11. Therefore, if the adapter assembly 1 is brought close to the vial 80 so that the cap 88 is housed inside the four guide bars 59, the tip 11a of the puncture needle 11 is easily aligned with the center of the stopper 87. be able to.

Preferably, the diameter of the inscribed circle of the four guide bars 59 is set to be substantially the same as the outer diameter of the cap 88. Thus, the tip end 11 a of the puncture needle 11 can be more accurately aligned with the center of the plug 87.

The diameter of the inscribed circle of the four guide bars 59 may be smaller than the outer diameter of the cap 88. In this case, the tip end 59a of the guide bar 59 abuts on the portion of the convex curved surface where the outer diameter near the upper end edge 88b (see FIG. 5) of the cap 88 gradually changes, and the tip end 59a is displaced radially outward. As a result, the guide bar 59 bends and deforms as appropriate. The elastic recovery force of the four guide bars 59 aligns the tip 11 a of the puncture needle 11 with the center of the plug 87. Thus, the adapter assembly 1 is adapted to a plurality of types of vials in which the outer diameter of the cap 88 is different.

When the tip 11 a of the puncture needle 11 contacts the plug 87, it is preferable that the claws 30 (in particular, the end 33 a of the rib 33) have not yet been in contact with the cap 88. However, depending on the outer diameter of the cap 88, the claw 30 may contact the cap 88 before the tip 11a of the puncture needle 11 contacts the plug 87. Even in this case, when the claw 30 contacts the cap 88 by appropriately setting the length of the guide bar 59 so that the guide bar 59 extends below the claw 30 (including the rib 33). In addition, it is possible to accommodate a part of the cap 88 (or the plug 87) in the area surrounded by the four guide bars 59. Therefore, also in the above case, the tip end 11 a of the puncture needle 11 can be easily aligned with the center of the plug 87.

With the puncture needle 11 aligned with the stopper 87 as shown in FIG. 6, the adapter assembly 1 is strongly pushed toward the vial 80. While the end 33 a of the claw 30 contacts the vicinity of the upper end 88 b of the cap 88, the claw 30 is displaced radially outward away from the puncture needle 11. When the claws 30 are displaced, the arms 20 elastically bend and deform. When the claws 30 pass through the cap 88, the arm 20 elastically recovers. The adapter assembly 1 can be attached to the vial 80, as shown in FIG. Similar to the adapter of Patent Document 1, the claws 30 are fitted into the constricted portion 84 (see FIG. 5) of the vial 80 and the claws 30 engage with the flanges 83. Although not shown, the puncture needle 11 passes through the plug 87, and the opening 13 (see FIG. 1A) is located below the plug 87. The inside of the vial 80 is in communication with the connector 40 via the flow path 12 of the puncture needle 11. The tip 59 a of the guide bar 59 reaches around the shoulder 85 of the bottle body 81. The guide bar 59 may be appropriately elastically bent and deformed so that the tip end 59a of the guide bar 59 is displaced radially outward in accordance with the change in the outer diameter of the bottle main body 81 at the shoulder 85.

Thereafter, the cover 50 is removed from the adapter 10. The adapter 10 remains attached to the vial 80. A male connector (for example, a male luer) is connected to the connector 40, and the drug in the vial 80 can be used to prepare a drug solution. As can be understood from FIG. 7, the guide bar 59 reduces the visibility of the tip 11 a of the puncture needle 11 via the bottle body 81 and the visibility of the drug or liquid in the vial 80. Removing the cover 50 from the adapter 10 improves their visibility.

After preparation of the drug solution, the cover 50 is attached to the adapter 10 again. The used vial 80 is discarded with the adapter assembly 1 attached (see FIG. 7). By mounting the cover 50 on the adapter 10, it is possible to prevent the chemical exposure to a chemical solution that may be attached to the top plate 48 of the connector 40 and the partition wall member 45 exposed through the opening 48a.

5. As described above, since the adapter assembly 1 of the present embodiment includes the guide bar 59 extending downward (the vial 80 side) than the puncture needle 11, the tip 11a of the puncture needle 11 is at the center of the plug 87. It can be easily aligned.

Unlike the present embodiment, it is possible to attach the adapter 10 to the vial 80 without using the cover 50. In this case, it is necessary to visually align the tip 11 a of the puncture needle 11 with the center of the plug 87. In this case, the positional displacement amount of the puncture needle 11 with respect to the plug 87 is likely to be large compared to the present embodiment. If the adapter 10 is pushed toward the vial 80 with the tip 11 a of the puncture needle 11 displaced from the center of the stopper 87, the claw 30 can not be engaged with the flange 83 of the vial 80. In contrast, the puncture needle 11 may be punctured obliquely. Further, depending on the outer diameter of the cap 88, the nail 30 may contact the cap 88 before the puncture needle 11 contacts the plug 87. In this case, when the adapter 10 is pushed toward the vial 80 with the tip 11a of the puncture needle 11 displaced from the center of the plug 87, the claw 30 slides on the cap 88 in the horizontal direction. For this reason, the vial 80 may tip over. Alternatively, the tip 11a of the puncture needle 11 may be caught on the edge of the opening 88a of the cap 88 while the nail 30 slides on the cap 88, and the puncture needle 11 may be bent due to the radial force applied to the tip 11a. is there. In the present embodiment, the possibility of the occurrence of such a problem is reduced.

In the present embodiment, the adapter assembly for the vial 80 is confirmed by confirming the vertical position of the tip 59a of each guide bar 59 with respect to the cap 88 in the state of FIG. 6 before puncturing the puncture needle 11 into the plug 87. It is easy to check the slope of 1 and correct it. For this reason, the puncture needle 11 can be punctured perpendicularly to the plug 87. Even if the tip 11a of the puncture needle 11 punctures the center of the plug 87, if the puncture needle 11 punctures the plug 87 at an angle, for example, the claw 30 can not be engaged with the flange 83 of the vial 80. It can happen. In the present embodiment, such a situation is unlikely to occur.

The plurality of guide bars 59 are circumferentially spaced. For this reason, as shown in FIG. 6, the position of the tip 11a of the puncture needle 11 relative to the plug 87 can be visually checked through the space between the adjacent guide bars 59.

The plurality of guide bars 59 are arranged along a circle concentric with the puncture needle 11. The guide bar 59 arranged in this manner is advantageous for improving the accuracy of the alignment of the tip 11 a of the puncture needle 11 with the center of the plug 87.

The guide bar 59 can be elastically bent and deformed so that its tip 59 a is separated from the puncture needle 11. Therefore, the adapter assembly 1 can be adapted to a plurality of types of vials having different outer diameters of the cap 88. Also, even if the tip 59a of the guide bar 59 collides with the shoulder 85 of the vial 80 in the process of attaching the adapter assembly 1 to the vial 80, the guide bar 59 is appropriately bent and deformed. It can be punctured to the desired depth.

In the present embodiment, the guide bar 59 is provided as a "guide mechanism" for aligning the tip 11a of the puncture needle 11 with the center of the plug 87, but the configuration of the guide mechanism of the present invention is not limited thereto. For example, the shape of the guide mechanism is not limited to this embodiment, and may be changed as appropriate. The guide mechanism does not have to extend linearly in parallel with the puncture needle 11 like the guide bar 59 in a natural state where no external force is applied. For example, the puncture needle approaches the tip (tip 59a) It may be curved away from 11. The guide mechanism may have a substantially "T" shape in which the tip end 59a of the guide bar 59 is circumferentially extended. Alternatively, the guide mechanism may have a substantially "U" shape in which the tips 59a of two guide bars 59 adjacent in the circumferential direction are connected. The cross-sectional shape of the guide mechanism along the horizontal plane is also not limited, and may be, for example, a circle, an ellipse, or an arc concentric with the puncture needle 11. The guide mechanism may be substantially incapable of radial elastic bending. The number and arrangement of the guide mechanisms are not limited to the present embodiment, and may be changed as appropriate. The number of guide mechanisms may be one, but is preferably two or more. The plurality of guide mechanisms can be arranged at equal angular intervals about the puncture needle 11. Alternatively, the pair of guide mechanisms may be spaced apart from each other around the puncture needle 11 in a state where the two guide mechanisms forming the pair face each other with the puncture needle 11 interposed therebetween.

The cover 50 includes a connector case 51 capable of housing the connector 40 of the adapter 10. The connector case 51 covers the top plate 48 of the connector 40 and the partition wall member 45 exposed through the opening 48 a. For example, as described above, if the cover 50 is attached to the adapter 10 just before connecting the male connector to the connector 40, the operation in attachment of the adapter assembly 1 to the vial 80, movement of the vial 80 thereafter, etc. The finger of the person does not touch the connector 40. Therefore, the sanitary condition of the connector 40 can be maintained well. In addition, after the chemical solution is prepared, if the cover 50 is attached again to the adapter 10 attached to the vial 80 and the vial 80 is discarded, the possibility of exposure to dangerous chemicals can be reduced.

The connector case 51 is disposed on the top of the cover 50. Therefore, when holding the cover 50, the worker is likely to pick the connector case 51 with a finger. For example, in the state of FIG. 6, the operator can push the adapter assembly 1 toward the vial 80 by pinching the connector case 51.

Differently from the above, it is assumed that when attaching the adapter assembly 1 to the vial 80, the operator applies a downward force to the shoulder 21 of the arm 20 projecting radially outward from the cover 50. As mentioned above, in order for the claw 30 to move over the cap 88 of the vial 80, the claw 30 needs to be displaced radially outward, and at this time, the arm 20 is bent and deformed so that the shoulder 21 is lifted upward. Do. The downward force applied by the operator to the shoulder 21 acts to inhibit this bending deformation of the arm 20. For this reason, the mounting operation of the adapter assembly 1 with respect to the vial 80 may be difficult, or the arm 20 may be broken (broken).

In the present embodiment in which the connector case 51 is provided on the top of the cover 50, the worker is likely to apply a downward force to the connector case 51 instead of the arm 20 (particularly the shoulder portion 21). Therefore, the above problems are unlikely to occur.

The peripheral wall 52 of the connector case 51 is provided with a pair of gripping surfaces 53 parallel to each other. Therefore, in the state of FIG. 6, the operator can hold the adapter assembly 1 most stably when holding the gripping surface 53 with two fingers. In other words, the worker is always instructed to pick the gripping surface 53. For example, the worker can grasp the gripping surface 53 with the thumb and forefinger (or middle finger) of the right hand. In this state, the operator pushes the adapter assembly 1 toward the vial 80. The operator can attach the adapter assembly 1 to the vial 80 without touching the adapter 10. Therefore, the possibility of the worker touching the arm 20 (especially the shoulder 21) is further reduced.

In the present embodiment, the expansion plate 58 protrudes radially outward from the lower end of the peripheral wall 52 of the connector case 51. When the connector case 51 (particularly its gripping surface 53) is pinched by the finger of one hand to apply a downward force, the finger can be applied to the upper surface of the expansion plate 58. Thus, the spreader plate 58 facilitates applying a downward force to the adapter assembly 1 when attaching the adapter assembly 1 to the vial 80. In addition, since the extension plate 58 prevents the operator's finger from extending downward from the extension plate 58, the possibility of the finger touching the arm 20 and erroneously applying a downward force to the arm 20 is reduced.

The extension plate 58 has a major axis in the direction (Y-axis direction) in which the pair of gripping surfaces 53 face each other. As a result, the projecting length of the expansion plate 58 projecting radially outward from the gripping surface 53 is generally larger than the projecting length of the expanding plate 58 projecting radially outward from the peripheral wall 52 other than the gripping surface 53. This is because when the gripping surface 53 is pinched with a finger and a downward force is applied, a finger can be applied to the portion of the expansion plate 58 having a relatively large projecting length, so that the adapter assembly 1 is given a downward force. Makes it easier to add.

The extension plate 58 is at a higher position than the arm 20. Since the finger gripping the connector case 51 and the other fingers hit the extension plate 58, the possibility that these fingers touch the arm 20 located lower than the extension plate 58 is low. Therefore, the expansion plate 58 is advantageous for reducing the possibility that the operator's finger touches the arm 20 and erroneously applies a downward force to the arm 20 when attaching the adapter assembly 1 to the vial 80. It is.

The direction (Y-axis direction) in which the pair of gripping surfaces 53 face is orthogonal to the direction (X-axis direction) in which the pair of arms 20 face. For example, when the pair of gripping surfaces 53 is pinched with the right thumb and forefinger and the adapter assembly 1 is pushed toward the vial 80, the middle finger is usually disposed in the vicinity of the forefinger, that is, near the gripping surface 53. Because there is no arm 20 below the middle finger, even if the middle finger extends below the expansion plate 58, there is a possibility that the middle finger will touch the arm 20 and inadvertently apply a downward force to the arm 20. Low. On the other hand, unlike the present embodiment, when the direction in which the pair of gripping surfaces 53 opposes matches the direction in which the pair of arms 20 opposes, if the middle finger extends below the extension plate 58, It can happen that the middle finger accidentally applies a downward force to the arm 20 (especially its shoulder 21). In this case, the above problem may occur. As described above, in the present embodiment, since the direction in which the gripping surface 53 faces is perpendicular to the extending direction of the arm 20, a finger other than the finger holding the gripping surface 53 touches the arm 20 to contact the arm 20. It is unlikely to accidentally apply a downward force.

In addition, in this invention, the planar view shape of the expansion board 58 is not limited to this embodiment, It is arbitrary. For example, the expansion plate 58 may be circular, concentric with the cover 50, or non-circular having a major axis in the X-axis direction. The expansion plate 58 does not have to be parallel to the XY plane, and may be inclined, for example, to descend toward its outer peripheral edge.

In the present invention, the expansion plate 58 may be omitted. For example, a guide bar 59 may extend downward from the lower end of the peripheral wall 52 of the connector case 51.

The gripping surface 53 need not be planar in the strict sense. The gripping surface 53 may be provided with a plurality of protrusions or a plurality of ribs (linear protrusions) in order to improve the gripping property and non-slip property, or the entire gripping surface 53 is a smooth concave surface May be composed of

The peripheral wall 52 of the connector case 51 may not be configured to always hold only a specific surface by the operator. For example, the pair of gripping surfaces 53 may be omitted, and the outer peripheral surface of the peripheral wall 52 may have any shape such as a cylindrical surface or a polygonal cylindrical surface (for example, a hexagonal cylindrical surface or an octagonal cylindrical surface). In this case, the worker can grip the peripheral wall 52 of the connector case 51 with two fingers in any direction.

The rib 56 provided on the inner peripheral surface of the connector case 51 functions as a “axis alignment structure” for making the cover 50 coaxial with the adapter 10. The coaxial arrangement of the case 50 with the adapter 10 is advantageous for improving the accuracy of the alignment of the tip 11 a of the puncture needle 11 with the center of the plug 87.

In the present embodiment, the axial alignment structure is constituted by four ribs 56, but the axial alignment structure of the present invention is not limited to this. For example, the inner peripheral surface of the peripheral wall 52 of the connector case 51 which is configured to omit the rib 56 and has an inner diameter substantially the same as the outer diameter of the peripheral wall 49 of the cap 47 and / or the annular protrusion 41b It may be used as

The projections 57 protruding from the ribs 56 function as an "engagement structure" for engaging the adapter 10. The engagement structure prevents the adapter 10 from falling off the cover 50 when the cover 50 (in particular, its connector case 51) is picked up and lifted from the adapter assembly 1 in which the cover 50 is attached to the adapter 10. Thus, the mounting operation of the adapter assembly 1 to the vial 80 can be easily performed.

In the present embodiment, the engagement structure is constituted by the projection 57 provided on the rib 56, but the engagement structure of the present invention is not limited to this. For example, the protrusion engaged with the adapter 10 may be provided on the inner peripheral surface of the peripheral wall 52 other than the rib 56 of the connector case 51. A protrusion engaging the adapter 10 may be annularly continuous with the inner circumferential surface of the circumferential wall 52. The protrusions may be configured to engage with the adapter 10 at locations other than the annular protrusion 41 b. The engagement structure need not be a protrusion but may be a recess (including a groove). In addition, the engagement structure may be provided at a location of the cover 50 other than the connector case 51. For example, the cover 50 may be provided with a recess or protrusion that engages with a protrusion 17 (see FIG. 2A) radially projecting from the adapter 10.

The present invention can be widely used as an adapter assembly attached to a vial. Above all, it can be preferably used in the medical field. The type of drug in the vial is not limited, but is suitable when it is a potent drug such as an anticancer drug.

Reference Signs List 1 adapter assembly 10 adapter 11 puncture needle 20 arm 30 claw 40 connector 50 cover 51 connector case 52 peripheral wall of connector case 53 grip surface 56 rib (alignment structure)
57 Protrusion (engagement structure)
58 Expansion plate 59 Guide bar (guide mechanism)
59a Guide bar tip 80 vial 83 flange 87 stopper

Claims

An adapter assembly comprising: a vial mountable adapter; and a cover separably mounted from above on said adapter, comprising:
The adapter is provided with a puncture needle capable of piercing the stopper of the vial, a plurality of claws engageable with the enlarged flange of the vial, and a plurality of elastically bendable plurality provided with the plurality of claws. Equipped with an arm,
The cover includes a guide mechanism extending to face the puncture needle.
An adapter assembly characterized in that the guide mechanism extends further downward than the puncture needle when the cover is attached to the adapter.
The cover includes a plurality of the guide mechanisms,
The adapter assembly according to claim 1, wherein the plurality of guide mechanisms are arranged along a circle concentric with the puncture needle.
The adapter assembly according to claim 1 or 2, wherein the guide mechanism is elastically deformable such that its tip is separated from the puncture needle.
The adapter comprises a connector in communication with the puncture needle,
The adapter assembly according to any one of claims 1 to 3, wherein the cover comprises a connector case for housing the connector.
The adapter assembly according to claim 4, wherein the connector case is disposed on the top of the cover.
The adapter assembly according to claim 4 or 5, wherein the peripheral wall of the connector case is provided with a pair of gripping surfaces parallel to each other.
The adapter assembly according to claim 6, wherein an expansion plate protrudes radially outward from the lower end of the peripheral wall of the connector case.
The adapter assembly according to claim 7, wherein the expansion plate has a major axis in a direction in which the pair of gripping surfaces face each other.
The adapter assembly according to claim 7, wherein the extension plate is at a higher position than the plurality of arms.
The plurality of arms are disposed to face each other in a first direction orthogonal to the longitudinal direction of the puncture needle,
The adapter according to any one of claims 6 to 9, wherein the pair of gripping surfaces are arranged to face in a second direction orthogonal to the first direction and orthogonal to the longitudinal direction of the puncture needle. Assembly.
The adapter assembly according to any one of the preceding claims, wherein an alignment structure is provided on the cover for coaxial alignment of the cover with the adapter.
The adapter assembly according to any one of the preceding claims, wherein an engagement structure is provided on the cover for engaging the adapter so as to prevent the adapter from falling off the cover.