JP2019025246A - Adaptor assembly - Google Patents

Abstract

To align puncture needlepoint of an adaptor in the center of a plug body of a vial.SOLUTION: An adaptor assembly 1 comprises an adaptor 10 which can be equipped with to a vial 80 and a cover 50 attached to the adaptor from upside separably. The adaptor comprises a puncture needle 11 which can puncture a plug body 87 of the vial, multiple clicks 30 engageable to a spread flange 83 of the vial, and multiple arms 20 provided with the multiple clicks and transformable elastically. The cover comprises a guide mechanism 59 extending to face to the puncture needle. In the state that the cover is attached to the adaptor, the guide mechanism extends further than the puncture needle towards downside.SELECTED DRAWING: Figure 1

Description

  The present invention relates to an adapter assembly including an adapter that can be attached to a vial and a cover that is detachably attached to the adapter.

  Vials filled with powdered drugs are 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 taken out from the vial. The injection of the solution into the vial and the extraction of the drug solution are performed through a puncture needle (sometimes referred to as a “bottle needle”) pierced into a plug (rubber plug) that seals the mouth (opening) of the vial.

  When the drug is a dangerous drug such as an anticancer drug, it is necessary to prevent the drug or the drug solution from leaking to the outside. Therefore, a claw that engages with an enlarged flange surrounding the mouth of the vial is provided integrally with the puncture needle so that the puncture needle that punctures the vial plug body does not unintentionally come out of the stopper body. Adapters are often used.

  An example of such an adapter is described in Patent Document 1. The adapter of Patent Document 1 includes a puncture needle and a claw that can be engaged with a flange of a vial. The claw is provided on an arm that can be bent and deformed elastically. 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 nail is displaced in a direction away from the puncture needle (ie, radially outward) by abutting against the plug (or an aluminum cap covering the same), and the arm is elastically bent and deformed. Thereafter, when the claw passes through the flange, the arm elastically recovers and the claw engages the flange of the vial.

International Publication No. 2016/152801 (FIGS. 9A to 11B)

  When the adapter is attached to the vial, the tip of the puncture needle is visually aligned with the center of the plug so that the puncture needle punctures the center of the plug, and then the adapter is pushed toward the vial. However, in practice, the tip of the puncture needle may be off the center of the plug. When the puncture needle punctures the position off the center of the stopper, it is difficult to engage the adapter claw with the vial flange, and thus the adapter cannot be properly attached to 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 includes an adapter that can be attached to a vial and a cover that is detachably attached to the adapter from above. The adapter includes a puncture needle that can puncture the stopper of the vial, a plurality of claws that can be engaged with a flange having an enlarged diameter of the vial, and a plurality of elastically bendable deformable members provided with the plurality of claws. Arm. The cover includes a guide mechanism extending so as to face the puncture needle. In a state where the cover is attached to the adapter, the guide mechanism extends further downward than the puncture needle.

  According to the present invention, in a 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 an embodiment of the present invention. FIG. 2A is a perspective view of an adapter according to an embodiment of the present invention as viewed from above. FIG. 2B is a perspective view of the adapter according to the embodiment of the present invention as viewed from below. FIG. 2C is a cross-sectional view taken along a plane including the central axis of the adapter according to the embodiment of the present invention. FIG. 3A is a perspective view of the cover according to the embodiment of the present invention as viewed from below. FIG. 3B is a cross-sectional perspective view of the cover according to the embodiment of the present invention as viewed from below. FIG. 3C is a plan view of a cover according to an embodiment of the present invention. FIG. 4A is a perspective view of an adapter assembly according to an embodiment of the present invention as viewed from above. FIG. 4B is a plan view of the adapter assembly according to the embodiment of the present invention. FIG. 4C is a cross-sectional view of the adapter assembly according to the embodiment of the present invention along a plane including the central axis. FIG. 4D is a cross-sectional view of the adapter assembly according to the 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 the embodiment of the present invention punctures the stopper of the vial. FIG. 7 is a perspective view showing a state where the adapter assembly according to the embodiment of the present invention is attached to a vial.

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

  The guide mechanism may be elastically deformable so that a tip thereof is separated from the puncture needle. According to such an aspect, the adapter assembly can be adapted to a plurality of types of vials having different outer diameters of the stoppers (or flanges). Further, even when the guide mechanism collides with the shoulder portion of the vial in the process of attaching the adapter assembly to the vial, the puncture needle can be punctured to a desired depth.

  The adapter may include a connector communicating with the puncture needle. The cover may include a connector case that houses the connector. According to this aspect, the sanitary state of the connector can be maintained satisfactorily. Further, by attaching a cover to a used adapter, the possibility of drug exposure can be reduced.

  The connector case may be disposed on an upper portion of the cover. According to this aspect, when the operator holds the cover, the operator is likely to pick the connector case with his / her finger. This is because when the adapter assembly is attached to the vial, the operator applies a downward force to the arm, so that it is difficult to attach the adapter assembly to the vial or the arm is broken (ruptured). This reduces the possibility that this will happen.

  A pair of gripping surfaces parallel to each other may be provided on the peripheral wall of the connector case. According to this aspect, the operator is always directed to pick the holding surface when holding the adapter assembly. This further reduces the likelihood that an operator will apply a downward force on the arm when attaching the adapter assembly to the vial.

  An expansion plate may protrude outward in the radial direction 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 prevents the operator's finger from touching the arm and applying a downward force to the arm by mistake when the adapter assembly is mounted on the vial.

  The expansion plate may have a long axis in a direction in which the pair of gripping surfaces face each other. Such an embodiment further facilitates applying a downward force to the adapter assembly by pinching the gripping surface with a finger.

  The extension plate may be positioned higher than the plurality of arms. Such an embodiment is advantageous in reducing the possibility that an operator's finger may touch the arm and inadvertently apply a downward force to the arm when the adapter assembly is attached to the vial.

  The plurality of arms may be arranged to face a first direction orthogonal to the longitudinal direction of the puncture needle. In this case, the pair of gripping surfaces may be arranged so as to face a second direction perpendicular to the first direction and perpendicular to the longitudinal direction of the puncture needle. Such an aspect is advantageous in reducing the possibility that a finger other than the finger holding the gripping surface touches the arm and erroneously applies a downward force to the arm when the adapter assembly is attached to the vial. is there.

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

  An engagement structure that engages with the adapter so that the adapter does not fall out of the cover may be provided in the cover. According to this aspect, the mounting operation of the adapter assembly to the vial can be easily performed.

  Below, this invention is demonstrated in detail, showing suitable embodiment. However, it goes without saying that the present invention is not limited to the following embodiments. Each drawing referred to in the following description shows simplified main members constituting an embodiment of the present invention for convenience of description. Therefore, within the scope of the present invention, arbitrary members not shown in the drawings may be added, or arbitrary members 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 the vial 80 and a cover 50 that can be repeatedly attached to and detached from the adapter 10. For convenience of the following explanation, an XYZ orthogonal coordinate system as shown is set. The Z axis is parallel to the central axis 1a of the adapter assembly 1 (see FIG. 2C described later. The central axis 1a coincides with the central axes of the adapter 10, the cover 50, and the vial 80). A direction parallel to the Z-axis is referred to as “vertical direction”. The side on which the Z-axis arrow is directed is called the “upper” side, and the opposite side is called the “lower” side. A direction parallel to a plane orthogonal to the Z axis (that is, the XY plane) is referred to as a “horizontal direction”. A direction along a straight line orthogonal to the central axis 1a is referred to as "radial direction", and a direction rotating around the central axis 1a is referred to as "circumferential direction".

1. Adapter FIG. 2A is a perspective view of the adapter 10 as viewed from above. FIG. 2B is a perspective view of the adapter 10 as viewed from below. FIG. 2C is a cross-sectional view taken 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 has a sharp tip 11a at its lower end. Inside the puncture needle 11, a flow path 12 through which a liquid (for example, a chemical solution) flows is formed along the central axis 1a. The channel 12 communicates with an opening 13 provided on the outer peripheral surface near the tip 11a of the puncture needle 11. The opening 13 opens outward in the radial direction.

  A tubular portion 14 surrounds a portion in the vicinity of the proximal end 11 b of the puncture needle 11. The tubular portion 14 has a hollow cylindrical shape, is disposed coaxially with the puncture needle 11, and is spaced apart from the puncture needle 11 in the radial direction. The upper end of the tubular portion 14 is connected to the proximal end 10 b of the puncture needle 10.

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

  The nail | claw 30 is provided in the lower end of the suspension part 22 so that it may protrude toward the puncture needle 11. FIG. The shoulder part 21 and the suspension part 22 which comprise the arm 20, and the nail | claw 30 are thin plate-shaped objects with the dimension of a Y-axis direction substantially constant. Each claw 30 includes two ribs 33 extending downward from the lower surface thereof. The rib 33 is a thin plate-like object substantially parallel to the XZ plane. The two ribs 33 provided on each claw 30 are separated from each other in the Y-axis direction. The rib 33 has an edge 33a extending downward starting from the tip 30a of the nail 30 (the portion of the nail 30 closest to the puncture needle 11) 30a. The end edge 33a is configured by a smooth convex curve. When viewed as a whole, the end edge 33a is inclined so as to be separated from the puncture needle 11 downward from the distal end 30a.

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

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

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

  From the lower end of the tubular portion 14, an arcuate flange portion 16 projects outward in the radial direction. The flange portion 16 is continuous with the shoulder portion 21 so as to form a substantially same plane as the shoulder portion 21 of the arm 20.

  In this embodiment, the arm 20 and the heel part 16 are integrated with the puncture needle 11 via the tubular part 14, but the present invention is not limited to this. For example, the tubular portion 14 may be omitted, and the shoulder portion 21 and the heel portion 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, a partition member (sometimes referred to as a “septum”) 45 provided at the upper end of the cylindrical portion 41, And a cap 47 placed on the partition wall member 45. The lumen 42 of the tubular portion 41 communicates with the flow path 12 in the puncture needle 11.

  The partition member 45 is a thin plate having a circular plan view shape. In 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 immediately returns to the state before deformation when the external force is removed.

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

  The cap 47 includes a top plate 48 having a disc shape and a peripheral 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. A pair of engagement holes 49 a are formed in the peripheral wall 49. The engagement hole 49a is a through hole that penetrates the peripheral wall 49 in the radial direction.

  The partition member 45 is sandwiched between the upper end of the cylindrical portion 41 and the top plate 48 of the cap 47 in the thickness direction (that is, the vertical direction). The engaging protrusion 41a protruding from the cylindrical portion 41 is fitted into the engaging hole 49a of the cap 47, whereby the cap 47 is engaged with the engaging protrusion 41a. The slit 45a of the partition member 45 is exposed in an opening 48a formed in the top plate 48 of the cap 47 (see FIG. 2A). The annular protrusion 41 b formed on 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 that is substantially the same as the outer peripheral surface of the peripheral wall 49.

  The connector 40 including the partition member 45 in which the slit 45a is formed is generally called a needleless port. In the initial state where the partition member 45 is not deformed, the slit 45a is closed to form a liquid-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 45a of the partition member 45, the partition member 45 is elastically deformed, and the lumen 42 of the cylindrical part 41 and the male luer communicate with each other. When the male luer is pulled out from the partition member 45, the partition member 45 immediately returns to the initial state, and the slit 45a is closed in a liquid-tight manner. Thus, the partition member 45 functions as a self-closing valve body.

  The part of the adapter 10 excluding the partition wall member 45 and the cap 47 is preferably manufactured integrally as a whole by injection molding a resin material. The resin material that can be used is not limited, but examples thereof include polyethylene, polypropylene, polycarbonate, styrene ethylene, polyethylene terephthalate, polybutylene terephthalate, and butylene styrene block copolymer. Considering that 20 is subjected to elastic bending deformation, polyolefin resins such as polyethylene and polypropylene are preferable. The material of the cap 47 is not limited, but is preferably a hard material. For example, a resin material such as polycarbonate, polypropylene, polyacetal, polyamide, hard polyvinyl chloride, or polyethylene 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, rubber materials such as isoprene rubber, silicone rubber, butyl rubber, A thermoplastic elastomer or the like 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.

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

  As shown in FIG. 3A, the connector case 51 has a hollow and substantially cylindrical shape, and its upper end is closed and its lower end is released. As will be 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 are 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 a substantially flat surface and is parallel to the XZ plane. The outer peripheral surface of the peripheral wall 52 excluding the gripping surface 53 is not limited, but is a smooth convex curved surface (for example, a cylindrical surface) in this embodiment (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 peripheral wall 52 downward beyond the extension plate 58. However, unlike the peripheral wall 52, the extension wall 55 is not continuous in an annular shape in the circumferential direction and is divided at two points. That is, the pair of extension walls 55 face each other in the Y-axis direction.

  Four ribs (protrusions) 56 protrude from the inner peripheral surface of the connector case 51 (only two ribs 56 are shown in FIG. 3B). The rib 56 extends from the peripheral wall 52 to the extension wall 55 along the vertical direction (that is, the Z-axis direction). The four ribs 56 are arranged at equiangular 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 protrusion 41b (see FIG. 2A). A projection 57 projects from the two ribs 56 facing each other across the central axis among the four ribs 56 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 protrusions 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 extension plate 58 is substantially parallel to the horizontal plane (XY plane). As shown in FIG. 3C, the expansion plate 58 is continuous in an annular shape around the connector case 51. The plan view shape of the outer peripheral edge of the extension plate 58 is a non-circular shape whose 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 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 that approximates a track. In other words, the extension plate 58 has a shape obtained by cutting a circle concentric with the central axis of the cover 50 by two parallel straight lines 58a. As a result, the protruding length in the radial direction of the extension 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 extension plate 58 includes two parallel straight lines 58a, a large number of covers 50 can be arranged in a vertical and horizontal direction on a horizontal plane with high density in an upright state with the connector case 51 facing up. . This facilitates handling of the cover 50 when the cover 50 is mass-produced, for example.

  In addition, the planar view shape of the expansion board 58 is not limited to this embodiment. The expansion plate 58 may have an arbitrary plan view shape such as an ellipse, an oval, a substantially rhombus, or a polygon (for example, a hexagon or an octagon). However, the extension plate 58 preferably has a long axis in the Y-axis direction as in the present embodiment. The expansion 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 peripheral wall 52. In this case, the protruding length along the X-axis direction of the extension plate 58 from the peripheral wall 52 is zero.

  As shown in FIG. 3A, a plurality of (four in this embodiment) guide bars 59 extend downward from the outer peripheral edge (particularly, arc 58 b) of the expansion plate 58. The guide bar 59 has a thin plate shape with a narrow width, and can be elastically bent and deformed so that a tip (or lower end) 59a thereof is in contact with or separated from the central axis. When viewed along the Z axis, the guide bar 59 in the initial state that is not deformed is arranged on a circle concentric with the cover 50.

  The cover 50 is preferably manufactured integrally as a whole by injection molding a resin material. The resin material that can be used is not limited, and examples thereof include polyethylene, polypropylene, polycarbonate, styrene ethylene, polyethylene terephthalate, polybutylene terephthalate, and butylene styrene block copolymer. Considering that the guide bar 59 is elastically bent and deformed, 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. 4A is a perspective view of the adapter assembly 1 in which the cover 50 is attached to the adapter 10 as seen 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 is in contact with the flange portion 16 (see FIG. 2A) of the adapter 10 in the vertical direction. Thereby, the insertion depth of the adapter 10 with respect to the connector case 51 is prescribed | regulated.

  Although not shown, a rib 56 (see FIG. 3B) provided on the inner peripheral surface of the connector case 51 contacts the peripheral wall 49 of the cap 47 and the annular protrusion 41b (see FIG. 2A). Thus, the cover 50 is aligned with the adapter 10 so as to be coaxial. Further, the protrusion 57 (see FIG. 3B) protruding from the rib 56 engages with the lower edge of the annular protrusion 41b. This prevents the adapter 10 from falling from the cover 50. In the process of attaching the cover 50 to the adapter 10, when the protrusion 57 gets over the annular protrusion 41b and engages with the annular protrusion 41b, the operator feels a click feeling on the fingertip. The operator can recognize that the cover 50 is correctly attached to the adapter 10 by this click feeling.

  When the cover 50 is attached to the adapter 10, the extension wall 55 and the protrusion 57 of the cover 50 position the adapter 10 in the vertical direction 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 distal end 59 a of the guide bar 59 is positioned below the distal end 11 a of the puncture needle 11. Preferably, the guide bar 59 extends further downward than the claw 30 (including the rib 33). That is, the front 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 is not in contact with the arm 20 (particularly, the shoulder portion 21) in the vertical direction. For this reason, the cover 50 attached to the adapter 10 does not hinder the elastic deformation of the arm 20.

  As shown in FIG. 4A, the expansion plate 58 of the cover 50 is located higher than the arm 20. The arm 20 (particularly the shoulder portion 21) protrudes radially outward from the expansion plate 58. The guide bar 59 extends further downward from the extension plate 58 beyond the arm 20. The rotation of the cover 50 around the central axis with respect to the adapter 10 causes the side edge 59b (see FIG. 4A) extending along the vertical direction of the guide bar 59 to move to the side edge that defines the width of the arm 20 in the Y-axis direction. Limited by colliding. The pair of arms 20 face each other in the X-axis direction, whereas the pair of gripping surfaces 53 of the cover 50 face each other in the Y-axis direction, and the long axis of the extension 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 each of the adapter 10 and the cover 50 in the vertical direction to release the engagement between the annular protrusion 41 b of the adapter 10 and the protrusion 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 fitted into a mouth (opening) 82 facing upward of the bottle body 81 and the mouth 82 is hermetically and liquid-tightly sealed. In the vial 80, a powdery medicine (not shown) is accommodated. An enlarged flange 83 is provided at the upper end of the bottle body 81 so as to surround the mouth 82. The outer peripheral surface of the flange 83 is a substantially cylindrical surface. The bottle body 81 has a constricted portion 84 having an outer diameter smaller than that of the flange 83 downward from the flange 83, a shoulder portion 85 whose outer diameter gradually increases downward, and the outer diameter is substantially constant in the vertical direction. Certain cylindrical portions 86 are adjacent to each other in this order.

  The plug 87 has substantially the same outer diameter as the flange 83. In order to prevent the stopper 87 from falling off from the mouth 82 of the bottle body 81, a cap 88 is attached to the stopper 87 and the flange 83. The cap 88 is made of a sheet of metal (for example, aluminum) or resin, and is in close contact with the plug 87 and the flange 83. The lower end of the cap 88 extends to the lower side of the outer peripheral surface which is a substantially cylindrical surface of the flange 83. The upper end of the cap 88 extends to the upper surface of the plug 87. A central region of the upper surface of the plug 87 is exposed to the outside through a circular opening 88a 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. Therefore, the outer peripheral surface 88c of the cap 88 attached to 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 end 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 include 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 facing upward. The tip 11a of the puncture needle 11 is brought closer to the upper surface of the plug body 87 while maintaining the adapter assembly 1 so that the central axis (or puncture needle 11) is parallel to the vertical direction. As described above, the guide bar 59 of the cover 50 extends below (the vial 80 side) from the tip 11a of the puncture needle 11. 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 plug 87) is accommodated 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. Accordingly, when the adapter assembly 1 is brought close to the vial 80 so that the cap 88 is accommodated 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. Thereby, the tip 11 a of the puncture needle 11 can be 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 front end 59a of the guide bar 59 abuts on a convex curved surface portion where the outer diameter gradually changes in the vicinity of the upper edge 88b (see FIG. 5) of the cap 88, and the front end 59a is displaced outward in the radial direction. Thus, the guide bar 59 is appropriately bent and deformed. 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. As described above, the adapter assembly 1 is adapted to a plurality of types of vials having different cap 88 outer diameters.

  When the tip 11a of the puncture needle 11 comes into contact with the plug 87, it is preferable that the claw 30 (particularly the end 33a of the rib 33) is not yet in contact with the cap 88. However, depending on the outer diameter of the cap 88, the nail 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 comes into contact with 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, a part of the cap 88 (or plug 87) can be accommodated in the area surrounded by the four guide bars 59. Therefore, also in the above case, the tip 11 a of the puncture needle 11 can be easily aligned with the center of the plug 87.

  In a state where the puncture needle 11 is aligned with the stopper 87 as shown in FIG. 6, the adapter assembly 1 is strongly pushed toward the vial 80. While the end edge 33a of the nail 30 is in contact with the vicinity of the upper end edge 88b of the cap 88, the nail 30 is displaced radially outward so as to be separated from the puncture needle 11. When the claw 30 is displaced, the arm 20 is elastically bent and deformed. When the claw 30 finishes passing through the cap 88, the arm 20 is elastically recovered. As shown in FIG. 7, the adapter assembly 1 can be attached to the vial 80. Similar to the adapter of Patent Document 1, the claw 30 is fitted into the constricted portion 84 (see FIG. 5) of the vial 80, and the claw 30 is engaged with the flange 83. Although not shown, the puncture needle 11 passes through the plug body 87, and its opening 13 (see FIG. 1A) is located below the plug body 87. The inside of the vial 80 communicates with the connector 40 through the flow path 12 of the puncture needle 11. The front end 59 a of the guide bar 59 reaches around the shoulder portion 85 of the bottle body 81. The guide bar 59 may be appropriately elastically bent and deformed so that the tip 59a of the guide bar 59 is displaced radially outward in accordance with a change in the outer diameter of the bottle 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, male luer) can be connected to the connector 40 to prepare a drug solution using the drug in the vial 80. As can be understood from FIG. 7, the guide bar 59 reduces the visibility of the tip 11 a of the puncture needle 11 through the bottle body 81 and the visibility of the medicine and liquid in the vial 80. The visibility is improved by removing the cover 50 from the adapter 10.

  After the chemical solution is prepared, the cover 50 is attached to the adapter 10 again. The used vial 80 is discarded in a state where the adapter assembly 1 is mounted (see FIG. 7). By attaching the cover 50 to the adapter 10, it is possible to prevent chemical exposure due to a chemical solution that may be attached to the top plate 48 of the connector 40 or the partition wall member 45 exposed through the opening 48 a.

5). As described above, the adapter assembly 1 of the present embodiment includes the guide bar 59 extending downward (vial 80 side) from the puncture needle 11, so that the distal end 11 a of the puncture needle 11 is located at the center of the plug 87. Can be easily aligned.

  Unlike the present embodiment, the adapter 10 can be attached to the vial 80 without using the cover 50. In this case, it is necessary to visually align the tip 11a of the puncture needle 11 with the center of the plug 87. In this case, the positional deviation amount of the puncture needle 11 with respect to the plug 87 is highly likely to be larger than that in the present embodiment. If the adapter 10 is pushed toward the vial 80 with the distal end 11 a of the puncture needle 11 being displaced from the center of the stopper 87, the claw 30 cannot be engaged with the flange 83 of the vial 80, On the other hand, the puncture needle 11 is punctured diagonally. 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, if the adapter 10 is pushed toward the vial 80 in a state where the tip 11a of the puncture needle 11 is displaced from the center of the stopper 87, the claw 30 slides on the cap 88 in the horizontal direction. For this reason, the vial 80 may fall. Alternatively, the tip 11a of the puncture needle 11 is caught by the edge of the opening 88a of the cap 88 while the nail 30 slides on the cap 88, and the puncture needle 11 is bent by applying a radial force to the tip 11a. is there. In this embodiment, possibility that such a problem will arise is reduced.

  In this embodiment, in the state of FIG. 6 before the puncture needle 11 is punctured into the plug body 87, the position of the tip 59a of each guide bar 59 with respect to the cap 88 is confirmed in the vertical direction, whereby the adapter assembly for the vial 80 is obtained. 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 body 87, if the puncture needle 11 punctures the plug body 87 at an angle, for example, the nail 30 cannot be engaged with the flange 83 of the vial 80. It can happen. In this embodiment, the possibility that such a situation will occur is low.

  The plurality of guide bars 59 are spaced apart in the circumferential direction. For this reason, as shown in FIG. 6, the position of the tip 11 a of the puncture needle 11 with respect to the plug 87 can be visually observed 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 in improving the accuracy of the alignment of the tip 11a of the puncture needle 11 with respect to the center of the plug 87.

  The guide bar 59 can be elastically bent and deformed so that its tip 59a is separated from the puncture needle 11. For this reason, the adapter assembly 1 can be adapted to a plurality of types of vials having different cap 88 outer diameters. Further, even when the tip 59a of the guide bar 59 collides with the shoulder portion 85 of the vial 80 in the process of mounting the adapter assembly 1 on the vial 80, the guide bar 59 is appropriately bent and deformed. Can be punctured to a desired depth.

  In the present embodiment, the guide bar 59 is provided as a “guide mechanism” for aligning the distal end 11a of the puncture needle 11 with respect to the center of the plug 87, but the configuration of the guide mechanism of the present invention is not limited to this. For example, the shape of the guide mechanism is not limited to this embodiment, and may be changed as appropriate. In a natural state where no external force is applied, the guide mechanism does not need to extend linearly in parallel with the puncture needle 11 like the guide bar 59. For example, the puncture needle approaches the tip (tip 59a). You may curve so that it may leave | separate from 11. The guide mechanism may have a substantially “T” shape in which the front end 59a of the guide bar 59 extends in the circumferential direction. 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. There is no restriction | limiting also about the cross-sectional shape along the horizontal surface of a guide mechanism, For example, circular, an ellipse, the circular arc concentric with the puncture needle 11, etc. may be sufficient. The guide mechanism may be substantially incapable of elastic bending deformation in the radial direction. 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 equiangular intervals around the puncture needle 11. Alternatively, a pair of one or more guide mechanisms may be spaced apart around the puncture needle 11 with the two guide mechanisms forming a pair facing each other with the puncture needle 11 in between.

  The cover 50 includes a connector case 51 that can accommodate 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 48a. For example, as described above, if the cover 50 is attached to the adapter 10 until just before the male connector is connected to the connector 40, the operation is performed in the attachment of the adapter assembly 1 to the vial 80, the subsequent movement of the vial 80, or the like. A person's finger or the like does not touch the connector 40. Therefore, the sanitary state of the connector 40 can be maintained satisfactorily. In addition, if the cover 50 is attached again to the adapter 10 attached to the vial 80 after the chemical solution is prepared and the vial 80 is discarded, the possibility of exposure to dangerous chemicals can be reduced.

  The connector case 51 is disposed on the upper part of the cover 50. For this reason, when the operator holds the cover 50, there is a high possibility that the operator will pinch the connector case 51 with a finger. For example, in the state of FIG. 6, the operator can pinch the connector case 51 and push the adapter assembly 1 toward the vial 80.

  Unlike the above, when attaching the adapter assembly 1 to the vial 80, consider a case where an operator applies a downward force to the shoulder portion 21 of the arm 20 protruding outward in the radial direction from the cover 50. As described above, in order for the claw 30 to get over the cap 88 of the vial 80, the claw 30 needs to be displaced radially outward. At this time, the arm 20 is bent and deformed so that the shoulder portion 21 is lifted upward. To do. The downward force that the operator applies to the shoulder 21 acts to inhibit this bending deformation of the arm 20. For this reason, it may be difficult to mount the adapter assembly 1 on the vial 80, or the arm 20 may be broken (broken).

  In the present embodiment in which the connector case 51 is provided on the upper portion of the cover 50, there is a high possibility that the operator applies a downward force to the connector case 51, not the arm 20 (particularly the shoulder portion 21). Therefore, it is unlikely that the above problem will occur.

  A peripheral wall 52 of the connector case 51 is provided with a pair of gripping surfaces 53 that are parallel to each other. Therefore, in the state of FIG. 6, the operator can hold the adapter assembly 1 most stably when the operator grips the gripping surface 53 with two fingers. In other words, the operator is always directed to pick the grip surface 53. For example, the operator can grip the grip surface 53 with the thumb and index finger (or middle finger) of the right hand. In this state, the operator pushes the adapter assembly 1 toward the vial 80. An operator can attach the adapter assembly 1 to the vial 80 without touching the adapter 10. Therefore, the possibility that the operator touches the arm 20 (particularly the shoulder portion 21) is further reduced.

  In the present embodiment, the extension 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, the gripping surface 53) is picked with a finger of one hand and a downward force is applied, the finger can be applied to the upper surface of the expansion plate 58. Accordingly, the expansion plate 58 facilitates applying a downward force to the adapter assembly 1 when the adapter assembly 1 is attached to the vial 80. Further, since the extension plate 58 prevents the operator's finger from extending downward from the extension plate 58, the possibility that the finger touches the arm 20 and a downward force is erroneously applied to the arm 20 is reduced.

  The extension plate 58 has a long axis in a direction (Y-axis direction) where the pair of gripping surfaces 53 face each other. As a result, the protruding length of the extension plate 58 protruding outward in the radial direction from the gripping surface 53 is generally larger than the protruding length of the extension plate 58 protruding outward in the radial direction 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, the finger can be applied to the portion of the expansion plate 58 having a relatively large protruding length, and therefore the downward force is applied to the adapter assembly 1. Make it easier to add.

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

  The direction (Y-axis direction) in which the pair of gripping surfaces 53 oppose each other is orthogonal to the direction in which the pair of arms 20 oppose (X-axis direction). For example, when the pair of gripping surfaces 53 are pinched with the thumb and index finger of the right hand and the adapter assembly 1 is pushed toward the vial 80, the middle finger is usually disposed in the vicinity of the index finger, that is, in the vicinity of the gripping surface 53. Since the arm 20 does not exist below the middle finger, even if the middle finger extends below the expansion plate 58, there is a possibility that the middle finger may touch the arm 20 and apply a downward force to the arm 20 by mistake. Low. On the other hand, unlike this embodiment, when the direction in which the pair of gripping surfaces 53 opposes the direction in which the pair of arms 20 opposes, the middle finger extends below the expansion plate 58. There may occur a situation in which the middle finger mistakenly applies a downward force to the arm 20 (particularly the shoulder portion 21). In this case, the above problem may occur. Thus, in this embodiment, since the direction in which the gripping surface 53 faces is perpendicular to the direction in which the arm 20 extends, a finger other than the finger that grips the gripping surface 53 touches the arm 20 and touches the arm 20. There is a low possibility of applying a downward force by mistake.

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

  In the present invention, the expansion plate 58 may be omitted. For example, the 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 a flat surface in a strict sense. In order to improve gripping properties and anti-slip properties, the gripping surface 53 may be provided with a plurality of protrusions or a plurality of ribs (linear protrusions), or the entire gripping surface 53 is a smooth concave surface. It may be comprised.

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

  The ribs 56 provided on the inner peripheral surface of the connector case 51 function as an “axis alignment structure” for making the cover 50 coaxial with the adapter 10. Arranging the case 50 coaxially with the adapter 10 is advantageous in improving the accuracy of the alignment of the tip 11a of the puncture needle 11 with respect to the center of the plug 87.

  In the present embodiment, the axis alignment structure is configured by the four ribs 56, but the axis alignment structure of the present invention is not limited to this. For example, the rib 56 is omitted, and the inner peripheral surface of the peripheral wall 52 of the connector case 51 configured so as to have 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 is an axial alignment structure. May be used as

  The protrusion 57 protruding from the rib 56 functions as an “engagement structure” that engages with the adapter 10. The engagement structure prevents the adapter 10 from falling off the cover 50 when the adapter assembly 1 with the cover 50 attached to the adapter 10 is lifted by picking up the cover 50 (particularly its connector case 51). For this reason, the mounting operation | work to the vial 80 of the adapter assembly 1 can be performed easily.

  In this embodiment, the engagement structure is constituted by the protrusions 57 provided on the rib 56, but the engagement structure of the present invention is not limited to this. For example, a protrusion that engages 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. The protrusion that engages with the adapter 10 may be annularly continuous with the inner peripheral surface of the peripheral wall 52. The protrusion may be configured to engage with a portion of the adapter 10 other than the annular protrusion 41b. The engagement structure does not need to be a protrusion, and may be a recess (including a groove). Further, the engagement structure may be provided at a location other than the connector case 51 of the cover 50. For example, you may provide the cover 50 with the recessed part or protrusion which engages with the convex part 17 (refer FIG. 2A) which protruded from the adapter 10 to radial direction.

  The present invention can be widely used as an adapter assembly attached to a vial. Among these, it can be preferably used in the medical field. Although the kind of medicine in a vial is not limited, it is suitable when it is a powerful medicine like an anticancer agent.

DESCRIPTION OF SYMBOLS 1 Adapter assembly 10 Adapter 11 Puncture needle 20 Arm 30 Claw 40 Connector 50 Cover 51 Connector case 52 Peripheral wall 53 of connector case Grip surface 56 Rib (Axis alignment structure)
57 Protrusion (engagement structure)
58 Expansion plate 59 Guide bar (guide mechanism)
59a Guide bar tip 80 Vial 83 Flange 87 Plug

Claims (12)

An adapter assembly comprising: an adapter that can be attached to a vial; and a cover that is detachably attached to the adapter from above.
The adapter includes a puncture needle that can puncture the stopper of the vial, a plurality of claws that can be engaged with a flange having an enlarged diameter of the vial, and a plurality of elastically bendable deformable members provided with the plurality of claws. Arm and
The cover includes a guide mechanism extending to face the puncture needle,
The adapter assembly, wherein 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, wherein the guide mechanism is elastically deformable so that a tip thereof is separated from the puncture needle. The adapter includes a connector communicating with the puncture needle,
The adapter assembly according to claim 1, wherein the cover includes a connector case that houses the connector.   The adapter assembly according to claim 4, wherein the connector case is disposed on an upper portion of the cover.   6. The adapter assembly according to claim 4, wherein a pair of gripping surfaces parallel to each other are provided on a peripheral wall of the connector case.   The adapter assembly according to claim 6, wherein an extension plate protrudes radially outward from a lower end of the peripheral wall of the connector case.   The adapter assembly according to claim 7, wherein the extension plate has a long axis in a direction in which the pair of gripping surfaces face each other.   The adapter assembly according to claim 7 or 8, wherein the expansion plate is positioned higher than the plurality of arms. The plurality of arms are arranged 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 so as to be opposed to a second direction perpendicular to the first direction and perpendicular to a longitudinal direction of the puncture needle. Assembly.   The adapter assembly as described in any one of Claims 1-10 with which the axis alignment structure which aligns the said cover coaxially with the said adapter is provided in the said cover.   The adapter assembly according to any one of claims 1 to 11, wherein an engagement structure that engages with the adapter so that the adapter does not fall out of the cover is provided on the cover.

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