JP5670242B2 - Drug preparation tool - Google Patents

Description

  The present invention relates to a drug preparation device including a prefilled syringe and a drug container.

  As a prefilled syringe, it is provided in the state with which medical liquids, such as a chemical | medical solution and a chemical | medical agent solution, were filled. The drug solution-filled prefilled syringe is used when administering a powder preparation that needs to be dissolved at the time of use, such as a freeze-dried preparation. A prefilled syringe filled with a drug solution is connected to a drug container (vial) containing a powder formulation, the solution in the syringe is injected into the drug container, and the powder formulation in the container is dissolved in the solution, then the syringe It becomes possible to administer by aspirating the inside. Generally, a metal needle is used to connect a pre-filled syringe filled with a drug solution to a drug container containing a powder formulation. Recently, a product using a dedicated connector has also been proposed. In addition, the administration preparation work may be performed not only by medical personnel but also by the patient himself who needs self-injection. In particular, patient preparations are often performed in environments where contamination is a concern and in unstable locations. Moreover, there is a risk of forgetting the dissolution work of the powder preparation, causing administration of only the solution in the prefilled syringe, liquid leakage, disconnection of the connection portion, and the like.

Japanese Patent No. 4216466 (Patent Document 1) discloses the following.
As shown in FIG. 1 of Patent Document 1, the transfer set 20 of Patent Document 1 includes a tube-shaped transfer member 46 and a central piercing member 48 supported by the tube-shaped transfer member so as to reciprocate. It consists of four components, including a cup-shaped cap 50 that covers and seals the assembly, and a collar member 52 that secures the transfer set to the drug container. As shown in FIGS. 1 and 2 of U.S. Patent No. 6,053,831, the proximal end of the tubular member 46 is preferably a circular or annular sealing lip with a sharp tip edge 56, as shown in FIG. 54 is provided. It will be appreciated that the proximal end of the tubular transfer member 46 includes a plurality of seal lips, such as the concentric seal lip 86 of the cap 50 described below. In the disclosed embodiment, the tubular transfer member 46 further comprises a radial connector portion 58 shown in FIG. A connector, such as a Luer lock 60, is provided adjacent the open end 62 of the tubular transfer member.

  Note that the drug container transfer set or fluid transfer assembly of Patent Document 1 is configured to establish fluid communication between a syringe, an intravenous (IV) device, and the like and a sealed drug container. The syringe and drug container are conventional and are manufactured to ISO standards. For this reason, the collar portion or tubular extension 129 of the tubular body portion 112 extends beyond the distal portion of the nozzle 114 and its inner surface is a female luer lock or commonly used to connect a needle to a syringe. It has a female thread.

Japanese Patent No. 4216466

In US Pat. No. 6,057,059, the syringe is manufactured according to ISO standards and the nozzle comprises a female luer lock or female thread commonly used to connect the needle to the syringe. If the drug solution is filled inside, there is a possibility of misadministration of only the solution.
An object of the present invention is to prevent only a medical liquid filled in a prefilled syringe from being administered, connect the prefilled syringe to a medicine container (vial) containing a medicine, and medical liquid in the prefilled syringe. The present invention proposes a drug preparation tool including a prefilled syringe and a drug container that can be easily transferred to a drug container, and re-stored in a prefilled syringe of a medical liquid in which the drug is dissolved.

What achieves the above object is as follows.
(1) The opening of the tip is sealed by an outer cylinder having an opened tip and a sealing member that is attached to the tip of the outer cylinder and can be pierced by a hollow needle, and conforms to ISO standards. A cap that cannot be connected to a medical device having a connection to a nozzle, a slidable gasket housed in the outer cylinder, a pusher that can be attached to the rear end of the gasket, and the outer A prefilled syringe made of medical liquid filled in a cylinder, a container body having an opening, a sealing member that seals the opening of the container body and is pierced by a hollow needle, and the container body A medicine container comprising a medicine container housed in a pre-filled syringe and a medicine container provided with an adapter connected to the opening sealed by the sealing member,
The adapter is a cylindrical body penetrating from one end to the other end, the adapter main body having a drug container connecting portion at the other end, and the other inside the adapter main body from the one end side. A puncture device movable in the end direction,
The puncture device includes a puncture device body having a cap attachment portion and a puncture device side engagement portion to which the cap of the prefilled syringe can be attached, and is fixed to the puncture device body, and one end protrudes into the cap attachment portion. A hollow needle having a first needle part capable of piercing the seal member of the cap to be mounted and a second needle part having the other end penetrating the sealing member of the drug container; With
The adapter body includes a guide portion that guides the puncture device side engagement portion of the puncture device from one end side to the other end side, and the guide portion extends in a circumferential direction of the adapter body. An axial direction guiding portion extending in the axial direction of the adapter body from the circumferential direction guiding portion and terminating, and provided in the circumferential direction guiding portion, engageable with the puncture device side engaging portion, and the puncture device A puncture device rotation restricting portion through which a side engagement portion can be forcibly passed; and a puncture device side engagement portion that is provided on one end side of a predetermined length from the end of the axial guide path and is engageable with the puncture device side engagement portion. A drug preparation tool comprising: a puncture device movement restricting portion for restricting movement of the puncture device after passage through a joint portion that can be forcibly passed.

(2) The drug preparation device according to (1), wherein the axial direction guiding portion includes an inclination guiding portion that extends in an axial direction and obliquely of the adapter main body, provided in a portion continuous with the circumferential direction guiding portion. .
(3) The puncture device side engaging portion is a protruding portion provided on an outer surface of the puncture device main body, and the guide portion of the adapter main body houses the protruding portion of the puncture device, and the protrusion The drug preparation tool according to (1) or (2) above, which is a guide path for guiding the part from one end side to the other end side.
(4) The guide path forms a circumferential guide that forms a puncture tool introduction path extending from one end of the adapter body to the other end and the circumferential guide section extending from the puncture tool introduction path in the circumferential direction of the adapter body. The drug preparation device according to (3), further comprising a path and an axial guide path that extends from the circumferential guide path in the axial direction of the adapter body and forms the axial guide section that terminates.
(5) The puncture device side engagement portion is a protrusion provided on the outer surface of the puncture device body, and the puncture device introduction path of the adapter body houses the protrusion of the puncture device, A puncture device guiding path for introducing the protruding portion into the circumferential direction guiding portion, and the puncture device introducing path projects inward from a wall surface of the puncture device introducing path, and the protruding portion of the puncture device The pharmaceutical preparation tool according to (4), further comprising a puncture tool withdrawal restricting protrusion that can be overcome.
(6) The puncture device is housed in the adapter main body so that the protruding portion of the puncture device is located at the terminal portion of the puncture device introduction path, and the puncture device is moved in the other end direction. Restricted by the bottom of the puncture device introduction path, movement in one end direction is regulated by the puncture tool detachment regulating projection, and movement in the circumferential direction is regulated by the puncture tool rotation regulating portion of the circumferential guide path. The drug preparation device according to (5), which is in a substantially stationary state.

(7) The adapter body is a cylindrical body penetrating from one end to the other end, an adapter outer cylinder having a drug container connecting portion at the other end, and a cylindrical body penetrating from one end to the other end, The drug preparation device according to any one of (1) to (6), further including an adapter inner cylinder housed in an adapter outer cylinder, wherein the guide portion is provided in the adapter inner cylinder.
(8) When the puncture device side engagement portion of the puncture device moves the axial direction guide portion of the adapter in the other end direction, the puncture device has the second needle portion of the puncture device, The drug preparation device according to any one of (1) to (7), wherein the seal member of the drug container is pierced.
(9) The drug preparation device according to any one of (1) to (8), wherein the cap is attached to the outer cylinder so as not to be detached.
(10) The distal end portion of the outer cylinder according to any one of (1) to (9), wherein connection to a medical device having a connection portion to a nozzle portion conforming to ISO standards is impossible. Drug preparation tool.

  According to the drug preparation device provided with the prefilled syringe and drug container of the present invention, the cap of the prefilled syringe is a medical device (for example, an injection needle, a three-way stopcock, an infusion circuit) having a connection part to a nozzle part conforming to the ISO standard. Therefore, only the medical liquid filled in the prefilled syringe is prevented from being administered. Then, by attaching the prefilled syringe from the cap side to the adapter puncture tool mounted on the drug container, the first needle portion of the hollow needle of the adapter puncture tool is inserted into the cap sealing member. The puncture device equipped with the prefilled syringe is moved to the other end side of the adapter, in other words, to the drug container side by a slight rotation of the prefilled syringe and the subsequent pushing, and the second needle portion of the hollow needle of the puncture device is Pierce the sealing member of the drug container. Thereby, the inside of a prefilled syringe and the inside of a medicine container communicate. Then, by attaching a plunger to the prefilled syringe and pushing the plunger, the medical liquid (dissolved solution) in the prefilled syringe is filled in the drug container, and the filled medical liquid (dissolved solution) is filled with the drug in the drug container. The drug is prepared by dissolving (powder drug). Then, by pulling the plunger, the prepared medicine is stored in the outer cylinder, and then, by rotating the syringe, the syringe is detached from the puncture tool, and a syringe containing the prepared medicine is prepared. Can do. Therefore, in the medicine preparation tool of the present invention, the connection of the prefilled syringe to the medicine container (vial) containing the medicine, the transfer of the medical liquid in the prefilled syringe to the medicine container, the medical liquid in which the medicine is dissolved A series of operations for re-housing in the prefilled syringe can be easily performed.

FIG. 1 is an external view of a drug preparation tool equipped with the prefilled syringe and drug container of the present invention. FIG. 2 is an enlarged longitudinal sectional view of a prefilled syringe used in the drug preparation device of the present invention. FIG. 3 is an enlarged longitudinal sectional view of an adapter-attached drug container used in the drug preparation device of the present invention. FIG. 4 is an enlarged front view of an outer cylinder and a cap of a prefilled syringe used in the drug preparation tool of the present invention. FIG. 5 is an enlarged longitudinal sectional view of the cap of the prefilled syringe shown in FIG. 6 is an enlarged perspective view of the prefilled syringe shown in FIG. 4 as viewed from below. FIG. 7 is an enlarged perspective view of the components of the adapter used in the drug preparation device of the present invention. FIG. 8 is an enlarged front view of the puncture device of the adapter used in the drug preparation device of the present invention. FIG. 9 is a longitudinal sectional view of FIG. FIG. 10 is a plan view of the puncture device shown in FIG. FIG. 11 is an enlarged front view of an adapter inner cylinder of an adapter used in the drug preparation device of the present invention. 12 is a vertical cross-sectional view of the adapter inner cylinder shown in FIG. FIG. 13 is an enlarged front view of an adapter outer cylinder of an adapter used in the drug preparation device of the present invention. 14 is a cross-sectional view taken along line AA in FIG. FIG. 15 is an enlarged front view of an adapter used in a drug preparation device according to another embodiment of the present invention. 16 is a longitudinal sectional view of the adapter shown in FIG. FIG. 17 is an explanatory diagram for explaining the action of the medicine preparation tool including the prefilled syringe and the medicine container of the present invention. FIG. 18 is an explanatory diagram for explaining the operation of the medicine preparation device including the prefilled syringe and the medicine container of the present invention. FIG. 19 is an explanatory diagram for explaining the action of the medicine preparation tool including the prefilled syringe and the medicine container of the present invention. FIG. 20 is an explanatory diagram for explaining the operation of the drug preparation tool including the prefilled syringe and drug container of the present invention. FIG. 21 is an explanatory diagram for explaining the operation of the drug preparation tool including the prefilled syringe and drug container of the present invention. FIG. 22 is an explanatory diagram for explaining the operation of the drug preparation tool including the prefilled syringe and drug container of the present invention.

Hereinafter, a medicine preparation tool provided with a prefilled syringe and a medicine container of the present invention will be described based on an embodiment shown in the drawings.
A drug preparation tool 1 including a prefilled syringe and a drug container according to the present invention includes an outer cylinder 10 having an open front end portion 13, and a seal member that is attached to the front end portion 13 of the outer cylinder 10 and can be pierced by a hollow needle 71. The cap 30 that seals the opening of the distal end portion 13 by 32 and cannot be connected to a medical device having a connection portion to a nozzle portion that conforms to the ISO standard, and a slidable member housed in the outer cylinder 10 Of the gasket 11, the plunger 5 attachable to the rear end of the gasket 11, the prefilled syringe 3 composed of the medical liquid 18 filled in the outer cylinder 10, the container main body 41 having an opening, and the container main body 41 A medicine container 4 comprising a sealing member 42 that seals the opening and can be pierced by the hollow needle 71 and a medicine 43 stored in the container body 41, and the sealing member 42 And a adapter 2 connected to the sealed opening.
The adapter 2 is a cylindrical body that penetrates from one end to the other end. The adapter main body 20 has a drug container connecting portion 61 at the other end, is accommodated in the adapter main body 20, and the inside of the adapter main body 20 is viewed from one end. And a puncture device 7 movable in the other end direction.

The puncture device 7 includes a puncture device main body 70 having a cap mounting portion 74 to which the cap 30 of the prefilled syringe 3 can be mounted and a puncture device side engagement portion (specifically, protrusions 73a and 73b provided on the outer surface). A first needle portion 71a that is fixed to the puncture device body 70, has one end projecting into the cap mounting portion 74, and can pierce the seal member 32 of the cap 30 to be mounted, and a sealing member 42 for the drug container. And a hollow needle 71 having a second needle portion 71b that can be pierced.
The adapter main body 20 includes a guiding portion that guides the puncture device side engaging portions 73a and 73b of the puncture device 7 from one end side to the other end side. The guide portion extends in the axial direction of the adapter body 20 from the circumferential guide portion (specifically, the circumferential guide paths 86a and 86b) extending in the circumferential direction of the adapter body 20, and the circumferential guide portions 86a and 86b, and Ending axial direction guiding portions (specifically, axial direction guiding paths 85a and 85b) and circumferential direction guiding portions 86a and 86b, which can be engaged with the puncture device side engaging portions 73a and 73b and are provided on the puncture device side A puncture device rotation restricting portion (specifically, puncture device rotation restricting protrusions 88a and 88b) through which the engaging portions 73a and 73b can be forcibly passed and provided at one end of a predetermined length from the end of the axial guide paths 85a and 85b. A puncture tool movement restricting portion (specifically, which is engageable with the puncture device side engaging portions 73a and 73b and through which the puncture device side engaging portions 73a and 73b can be forcibly passed and restricts the movement of the puncture device 7 after passing) Includes a puncture tool movement restricting projection 89a, 9b) and a.

As shown in FIG. 1, the drug preparation tool 1 of the present invention includes a prefilled syringe 3 sealed with a cap 30, a drug container 4, an adapter 2 attached to the drug container 4, and a plunger 5. . And the adapter 2 consists of the adapter main body 20 and the puncture tool 7 which can move the inside of the adapter main body 20 as shown in FIG. 1, FIG.
The prefilled syringe 3 includes an outer cylinder 10, a cap 30 that seals the distal end portion 13 of the outer cylinder 10, a gasket 11 that is housed in the outer cylinder 10, and an inside of the outer cylinder 10 that is sealed by the cap 30 and the gasket 11. And a medical liquid 18 stored (filled) in the container.
As shown in FIGS. 1, 2, and 4, the outer cylinder 10 includes a main body portion 12, a tip portion 13, and a flange 14. The main body 12 is substantially cylindrical and has a liquid storage space inside.

The tip portion 13 protrudes from the shoulder portion of the main body portion 12 in the tip direction. The distal end portion 13 is provided with a distal end opening for discharging a chemical solution or the like in the outer cylinder and cannot be connected to a medical device having a connection portion to a nozzle portion conforming to the ISO standard. That is, it is not a luer taper shape that the tip of a normal syringe has. In particular, in the outer cylinder 10 of this embodiment, the distal end portion 13 has an enlarged diameter portion 15 formed at a boundary portion with the main body portion 12 and a concave portion 17 (specifically, facing each other). Two recesses) and a rib 16 (specifically, two ribs facing each other) provided in the vicinity of the central portion in the axial direction of the distal end portion 13 are provided. The rib 16 extends a predetermined length in the circumferential direction. The two recesses 17 and the two ribs 16 are provided so as not to overlap in the axial direction. In particular, in this outer cylinder, the concave portions 17 and the ribs 16 are shifted by approximately 90 degrees with respect to the central axis of the tip portion 13.
A small diameter portion 18 is formed at the tip of the tip portion 13, and the tip of the small diameter portion 18 is open.

The flange 14 is an elliptical donut-shaped disk portion formed so as to protrude in the vertical direction from the entire rear end circumference of the outer cylinder 10. The flange 14 includes two gripping portions facing each other as shown in FIGS. 1, 2, and 4, and a plurality of ribs are formed on the front end surface side of the gripping portion.
The outer cylinder 10 is a cylindrical body made of a transparent or translucent material and, if necessary, a material having low oxygen permeability and water vapor permeability.
Examples of the material for forming the outer cylinder 10 include polypropylene, polyethylene, polystyrene, polyamide, polycarbonate, polyvinyl chloride, poly- (4-methylpentene-1), acrylic resin, acrylonitrile-butadiene-styrene copolymer, polyethylene terephthalate. Various resins such as polyester and cyclic polyolefin can be used, and among them, resins such as polypropylene and cyclic polyolefin are preferable because they are easy to mold and have heat resistance.
Moreover, the front-end | tip part 13 of the outer cylinder 10 is sealed with the cap 30 mentioned later.

As shown in FIG. 2, the gasket 11 includes a main body portion extending at substantially the same outer diameter and a plurality of annular ribs provided on the main body portion, and these ribs are formed on the inner surface of the main body portion 12 of the outer cylinder 10. Contact closely.
As a material for forming the gasket 11, rubber having elasticity (for example, butyl rubber, latex rubber, silicone rubber, styrene-butadiene rubber, isoprene rubber, etc.), thermoplastic elastomer (for example, SBS elastomer, SEBS elastomer, SEPS elastomer, styrene, etc.) It is preferable to use olefin-based elastomers, olefin-based elastomers such as ethylene-α-olefin copolymer elastomers, and the like.
The gasket 11 is provided with a recess extending inward from the rear end thereof, and this recess serves as a plunger mounting portion 11a. Specifically, the plunger mounting portion 11 a has a female screw shape, and can be screwed with a male screw portion formed on the outer surface of the gasket mounting portion 51 formed at the distal end portion of the plunger 5. The plunger 5 is attached to the gasket 11 by screwing them together.
As shown in FIG. 1, the plunger 5 includes a gasket mounting portion 51 provided at the front end portion, a main body portion 50 extending in the axial direction having a cross-shaped cross section, and a pressing portion 53 provided at the rear end portion of the main body portion. And a reinforcing rib provided in the middle of the main body 50. In the plunger of this embodiment, a male thread portion that is screwed with the plunger mounting portion 11a is formed on the outer surface of the plunger mounting portion. The plunger 5 is connected to the gasket 11 by screwing the plunger mounting portion 11a and the gasket mounting portion 51 together.
The medical liquid 18 filled in the prefilled syringe 3 contains a drug solution such as distilled water for injection, physiological saline, and aqueous glucose solution, and further contains a drug (for example, vitamin and mineral), It may be a chemical solution capable of dissolving the powder preparation in the drug container.

As shown in FIGS. 2 and 4 to 6, the cap 30 includes a main body 31 and a seal member 32 housed in the main body 31.
The main body 31 is a cylindrical body, and has a small-diameter opening 33 provided at the distal end, a flange 35 provided at the proximal end, and a window provided at the side (specifically, two facing each other). Two window portions 36a, 36b), a cap-side threaded portion 34 provided on the outer surface on the tip side from the window portion, and a rib 38 formed on one end side from the flange portion 35 and on the other end side from the window portions 36a, 36b. (A plurality of circumferential ribs) and a rib 37 provided on the inner surface of the base end portion.
In the cap 30 of this embodiment, the window portions 36a and 36b are for accommodating the ribs 16 of the outer cylinder 10 and extend a predetermined length in the circumferential direction. The rib 16 of the outer cylinder 10 enters and engages with the window portions 36 a and 36 b of the cap 30, thereby preventing the cap from being detached from the outer cylinder 10. Therefore, in the prefilled syringe 3 of this embodiment, the cap 30 is attached so as not to be detached from the outer cylinder 10. When the cap 30 is attached to the outer cylinder 10, each rib 37 of the cap 30 enters and engages with each concave portion 17 of the outer cylinder 10. For this reason, the cap 30 is not rotatable with respect to the outer cylinder 10. Therefore, when the outer cylinder 10 is rotated, the cap 30 follows and rotates.

Examples of the cap forming material include polypropylene, polyethylene, polystyrene, polyamide, polycarbonate, polyvinyl chloride, poly- (4-methylpentene-1), acrylic resin, acrylonitrile-butadiene-styrene copolymer, and polyethylene terephthalate. Various resins such as polyester and cyclic polyolefin may be mentioned. Among them, resins such as polypropylene and cyclic polyolefin are preferable because they are easy to mold and have heat resistance.
The seal member 32 is housed in the distal end portion of the main body 31 and seals the opening 33, and in the state where the cap 30 is mounted on the distal end portion 13 of the outer cylinder 10 as shown in FIG. 10 tip openings are sealed fluid-tight. The sealing member 32 is an elastic member that can seal the distal end opening of the distal end portion 13 of the outer cylinder 10 in a liquid-tight manner and can be pierced by a first needle portion (outer cylinder side puncture portion) of the puncture device 7 described later. It is preferable.
As a material for forming the sealing member, it is preferable to use, for example, natural rubber, isoprene rubber, butadiene rubber, fluororubber, silicone rubber or other synthetic rubber, or thermoplastic elastomer such as olefin elastomer or styrene elastomer.

Next, the adapter 2 will be described with reference to FIGS. 1, 3, 7 to 14, 18, and 19.
The adapter 2 is a cylindrical body that penetrates from one end to the other end. The adapter main body 20 has a drug container connecting portion 61 at the other end, and a puncture that can move in the adapter main body 20 from the one end to the other end. The tool 7 is provided.
In this embodiment, the adapter main body 20 is a cylindrical body penetrating from one end to the other end, the adapter outer cylinder 6 having the drug container connecting portion 61 at the other end, and the cylinder penetrating from one end to the other end. The adapter is composed of an adapter inner cylinder 8 housed in the adapter outer cylinder 6, and the puncture tool 7 moves in the adapter inner cylinder 8 from the one end side toward the other end.
As shown in FIGS. 3, 7, 13, and 14, the adapter outer cylinder 6 has a cylindrical main body 60 with one end and the other end opened, and a medicine provided at the base end (lower end). And a container connecting portion 61. The cylindrical main body 60 has substantially the same inner diameter as a whole. An annular recess 64 is provided on the inner surface of the base end portion of the cylindrical main body 60.
As shown in FIG. 3, the medicine container connecting portion 61 accommodates one end side portion including the opening of the medicine container sealed by the sealing member 42. Further, the adapter outer cylinder 6 includes an engaging part for suppressing the detachment of the medicine container attached to the medicine container connecting part 61. Specifically, as shown in FIG. 3 and FIG. 14, the inner surface of the drug container connecting portion 61 of the adapter outer cylinder 6 protrudes inward and is below the opening 44 of the drug container (the lower part of the neck of the drug container). ) And a plurality of protrusions 63 that engage with each other, and the protrusions 66 constitute an engaging part. Further, a plurality of slits 62 extending in the axial direction are provided at the proximal end portion of the medicine container connecting portion 61 for assisting deformation when the medicine container 4 is mounted.

The puncture device 7 is a member that is accommodated in the adapter main body 20, specifically, the adapter inner cylinder 8, and is movable (slidable) in the adapter inner cylinder 8 from the one end side toward the other end.
The puncture device 7 includes a puncture device main body 70 and a hollow needle 71 fixed to the puncture device main body 70.
As shown in FIGS. 7 to 10, the puncture device body 70 is a short cylindrical body having a hollow needle fixing portion having a small diameter at the other end, and the cap 30 of the prefilled syringe 3 can be attached to the inside thereof. A cap mounting portion 74 is provided. Specifically, the cap mounting portion 74 includes a puncture device side threaded portion that is threadedly engaged with the cap side threaded portion 34 provided on the outer surface of the cap 30. In this embodiment, the cap side screwing portion 34 constitutes a male screw, and the puncture device side screwing portion constitutes a female screw. Furthermore, the puncture device main body 70 includes an annular rib 75 provided in the vicinity of the opening on the one end side. The annular rib 75 engages with a rib 38 (a plurality of circumferential ribs) formed slightly on one end side from the flange portion of the cap 30, so that the syringe 3 (after the prefilled syringe 3 is attached to the puncture tool 7 ( The removal of the cap 30) is regulated. The puncture device 7 includes a puncture device side engaging portion provided in the puncture device main body 70. In this embodiment, the puncture device side engaging portion is constituted by projecting portions 73 a and 73 b provided on the outer surface of the puncture device main body 70.

  The hollow needle 71 is fixed to the hollow needle fixing portion 72 of the puncture device main body 70, and one end side protrudes into the cap mounting portion 74 from the fixing portion 72, and the seal member 32 of the cap 30 can be inserted into the tip thereof. 1st needle part 71a (syringe side puncture part) is provided. Further, the other end side of the hollow needle 71 protrudes outward (in the other end direction) from the fixing portion 72, and a second needle portion 71b (drug container) through which the sealing member 42 of the drug container 4 can be pierced at the tip thereof. Side puncture part). Further, the hollow needle 71 extends substantially parallel to the central axis of the adapter inner cylinder 8. In addition, the puncture device 7 is disposed at a position where the second needle portion 17b (the drug container side puncture portion) of the hollow needle 71 does not contact the drug container 4 attached to the adapter main body 20. Specifically, as shown in FIG. 3, the puncture device 7 is placed in the adapter 2 so that the second needle portion 71b of the puncture device 7 does not contact the sealing member 42 of the medicine container 4 to be mounted. It is stored. As shown in FIG. 3, the puncture device 7 is disposed at a position slightly on the other end side from the opening on one end side of the adapter main body 20 (adapter inner cylinder 8).

As shown in FIGS. 3, 7, 11, 12, 18 and 19, the adapter main body 20 houses the protruding portions 73a and 73b which are puncture device side engaging portions of the puncture device 7. In addition, a guide path is provided for guiding the protrusions 73a and 73b from one end side to the other end side. In particular, in the adapter 2 of this embodiment, the guide path is provided in the adapter inner cylinder 8 that houses the puncture device 7.
Specifically, the adapter main body 20 is provided with a guide path that houses the protrusions 73a and 73b of the puncture device 7 and guides the protrusions 73a and 73b from one end side to the other end side. The guide paths include puncture tool introduction paths 84a and 84b extending from one end of the adapter body to the other end, circumferential guide paths 86a and 86b extending from the puncture tool introduction paths 84a and 84b in the circumferential direction of the adapter body, and circumferential guidance. The axial guide paths 85a and 85b that extend in the axial direction of the adapter main body from the paths 86a and 86b and terminate and the wall surfaces of the puncture instrument introduction paths 84a and 84b project inward, and the projecting sections 73a and 73b of the puncture instrument 7 Puncturing tool detachment restricting projections 87a, 87b that can be overcome, and puncture tool rotation restricting projections 88a that project inward from the wall surfaces of the circumferential guide paths 86a, 86b and that can be overtaken by the projecting portions 73a, 73b of the puncture tool 7. 88b and a puncture tool movement rule that protrudes inward from the wall surface at one end of a predetermined length from the end of the axial guide paths 85a and 85b, and is able to get over the protrusions 73a and 73b of the puncture tool 7. Use protrusion 89a, and a 89b.

That is, in this embodiment, the puncture device side engaging portion is the protruding portions 73 a and 73 b provided on the outer surface of the puncture device main body 70, and the guiding portion of the adapter main body 20 is the protruding portions 73 a and 73 b of the puncture device 7. And a guide path for guiding the protrusions 73a and 73b from one end side to the other end side.
In the present invention, the puncture device side engagement portion of the puncture device main body 70 and the guide portion of the adapter main body 20 are not limited to the above, and the puncture device side engagement of the puncture device main body 70 is not limited to the above. A part may be a groove-shaped thing and the guide part of the adapter main body 20 may be a convex part.
Further, in this embodiment, the guide path of the adapter body 20 is the puncture tool introduction paths 84a and 84b extending from one end of the adapter body 20 to the other end, and the circumference of the adapter body 20 from the puncture tool introduction paths 84a and 84b. Circumferential guide passages 86a and 86b forming circumferential guide portions extending in the direction, and axial guide passages forming axial guide portions extending from the circumferential guide passages 86a and 86b in the axial direction and terminating. 85a, 85b.

Further, in this embodiment, the puncture tool rotation restricting portion protrudes inward from the wall surfaces of the circumferential guide paths 86a and 86b, and the protrusion 73a and 73b of the puncture device 7 can get over the protrusion for restricting the puncture tool rotation. The puncture tool movement restricting portion protrudes inward from the wall surface on one end side of the predetermined length from the end of the axial guide path 85a, 85b, and the puncture device 73 can protrude over the protrusion portions 73a, 73b. These are tool movement restricting projections 89a and 89b.
Further, in this embodiment, the puncture tool introduction paths 84a and 84b protrude inward from the wall surfaces of the puncture tool introduction paths 84a and 84b, and the puncture tool detachment restriction that allows the protrusions 73a and 73b of the puncture tool 7 to get over. Protrusions are provided. As will be described later, in this embodiment, the axial guide paths 85a and 85b are provided with inclined guide paths that extend in the axial direction and obliquely of the adapter body provided in a portion continuous with the circumferential guide path. Yes.

As shown in FIGS. 11 and 12, the adapter inner cylinder 8 includes a cylindrical main body portion 80 and a flange portion 81 provided at the base end portion (lower end) of the main body portion 80. The cylindrical main body 80 has a substantially identical inner diameter as a whole. An annular rib 83 that engages with an annular recess 64 provided on the inner surface of the base end portion of the main body portion 60 of the adapter outer cylinder 6 is provided on the outer surface of the base end portion of the cylindrical main body portion 80.
The guide path is formed in the cylindrical main body portion of the adapter inner cylinder 8.
The guide paths include puncture tool introduction paths 84a and 84b extending from one end of the adapter inner cylinder 8 to the other end, circumferential guide paths 86a and 86b extending from the puncture tool introduction paths 84a and 84b in the circumferential direction of the adapter body, The axial guide paths 85a and 85b extend from the direction guide paths 86a and 86b in the axial direction of the adapter body and terminate.
Further, in the adapter 2 of this embodiment, the axial guide paths 85a and 85b are inclined guide paths 90a and 90b extending in the axial direction and obliquely of the adapter main body provided in a portion continuous with the circumferential guide paths 86a and 86b. I have.
Further, the adapter inner cylinder 8 protrudes inward from the wall surfaces of the puncture device introduction paths 84a and 84b, and the puncture tool detachment restricting projections 87a and 87b that can be overridden by the protrusions 73a and 73b of the puncture device 7 and circumferential guidance. Protrusions for restricting rotation of puncture tool 88a, 88b projecting inward from the walls of the paths 86a, 86b and over which the protrusions 73a, 73b of the puncture tool 7 can be passed, and one end of a predetermined length from the end of the axial guide paths 85a, 85b The projections 73a and 73b of the puncture device 7 are projected inward from the wall surface of the puncture device 7 and are provided with projections 89a and 89b for restricting movement of the puncture device.
Further, as described above, the puncture device 7 has the two projecting portions 73a and 73b so as to face each other, and the adapter main body 20 (adapter inner cylinder 8) corresponds to the protrusions 73a and 73b. Two guide paths capable of guiding the two protrusions 73a and 73b are provided.

Each taxiway will be described in more detail.
As shown in FIGS. 3, 7, 11, 12, 18, and 19, the puncture tool introduction paths 84 a and 84 b are arranged on the center axis of the adapter inner cylinder 8 from one end to the other end side of the adapter inner cylinder 8. The width of the puncture device 7 is such that the protrusions 73a and 73b of the puncture device 7 can be accommodated. For this reason, when the puncture device 7 is inserted into the adapter body 20 (adapter inner cylinder 8) from the second needle portion 71b side so that the protruding portions 73a and 73b enter the puncture device introduction paths 84a and 84b, The puncture device 7 enters until the projecting portions 73a and 73b abut on the puncture device detachment restricting projections 87a and 87b in the puncture device introduction paths 84a and 84b. The portions where the puncture tool detachment restricting projections 87a and 87b are formed are narrow portions as viewed from other portions of the puncture device introduction paths 84a and 84b. Further, when the puncture device 7 is pushed, the protrusions 73a and 73b of the puncture device 7 get over the puncture device detachment restricting projections 87a and 87b of the puncture device introduction paths 84a and 84b, and the bottom parts of the puncture tool introduction paths 84a and 84b. To reach. This state is the state shown in FIG. In this state, the protrusions 73a and 73b of the puncture device 7 are restricted from moving in the other end direction by the bottom portions of the puncture device introduction paths 84a and 84b, and the movement in the one end direction is puncturing the puncture tool introduction paths 84a and 84b. Restricted by the tool detachment restricting protrusions 87a and 87b, movement in the circumferential direction (rotation of the puncture tool 7) is restricted by the puncture tool rotation restricting protrusions 88a and 88b of the circumferential guide paths 86a and 86b, and substantially. It does not move.

  11, 12, 18, and 19, the adapter inner cylinder 8 includes circumferential guide paths 86a and 86b that extend in the circumferential direction of the adapter body from the puncture instrument introduction paths 84a and 84b. . The puncture tool rotation restricting protrusions 88a and 88b are small protrusions that protrude upward from the bottom surface in the vicinity of the start ends of the circumferential guide paths 86a and 86b. By slightly rotating the puncture device 7, the projecting portions 73a and 73b rotate while sliding on the puncture device rotation restricting projections 88a and 88b, travel along the circumferential guide paths 86a and 86b, and completely project. When the parts 73a and 73b get over the puncture tool rotation restricting protrusions 88a and 88b, the entire protrusions 73a and 73b are accommodated in the circumferential guide paths 86a and 86b. The adapter inner cylinder 8 is provided with inclined guiding paths 90a and 90b provided at portions continuous with the circumferential guiding paths 86a and 86b. The inclined guiding paths 90a and 90b are as shown in FIGS. Further, the adapter inner cylinder 8 extends obliquely at a predetermined angle with respect to the other end direction (axial direction) and the center axis of the adapter inner cylinder. The other ends of the inclined guiding paths 90a and 90b are continuous with the axial guiding paths 85a and 85b. The axial guide paths 85 a and 85 b extend for a predetermined length in parallel to the central axis of the adapter inner cylinder 8, and terminate without reaching the other end of the adapter inner cylinder 8. In particular, in this embodiment, the axial guide paths 85a and 85b terminate near the center of the adapter inner cylinder 8 in the axial direction.

  The axial guide paths 85a and 85b are provided with puncture tool movement restricting projections 89a and 89b that protrude from the inner wall of the portion that is slightly on the one end side from the end. The protrusions 73a and 73b of the puncture device 7 can get over the puncture device movement restriction projections 89a and 89b. When the protrusions 73a and 73b of the puncture device 7 get over the protrusions 89a and 89b for restricting the movement of the puncture device and the protrusions 73a and 73b are in contact with the terminal ends of the axial guide paths 85a and 85b, Movement is restricted by the bottom portions (terminals) of the axial guide paths 85a and 85b, movement in one end direction is restricted by the puncture tool movement restriction projections 89a and 89b, and movement in the circumferential direction (rotation of the puncture tool 7) However, it is regulated by the side portions of the axial guide paths 85a and 85b, and is not substantially moved. The puncture tool movement restricting projections 89a and 89b of the axial guide paths 85a and 85b are in the direction of one end of the puncture tool 7 after the protrusions 73a and 73b of the puncture tool 7 have passed over the puncture tool movement restricting protrusions 89a and 89b. Restrict movement to

Therefore, in this embodiment, the puncture device 7 is in a state in which the protrusions 73a and 73b of the puncture device 7 get over the puncture device detachment restricting projections 87a and 87b and contact the lower ends of the puncture device introduction paths 84a and 84b. Then, by rotating the puncture tool 7, the protrusions 73a and 73b move in the circumferential guide paths 86a and 86b, and further, by pushing the puncture tool 7 toward the lower end in the axial direction, the second guide path 85a and 85b is moved in the direction of the other end.
In addition, the puncture device 7 includes the second puncture device 7 when the protruding portions 73a and 73b of the puncture device 7 move along the second guide paths 85a and 85b (including the inclined guide paths) in the other direction. The needle portion 71b pierces the sealing member 42 of the drug container 4.
Also, puncture tool introduction paths 84a and 84b, puncture tool detachment restricting protrusions 87a and 87b, circumferential guide paths 86a and 86b, puncture tool rotation restricting protrusions 88a and 88b, tilt guide paths 90a and 90b, and axial guide path 85a. 85b and the puncture tool movement restricting projections 89a and 89b are formed so as to be substantially symmetrical with respect to the central axis of the adapter inner tube 8, respectively. In addition, although it is preferable to provide the inclined guiding paths 90a and 90b, the inclined guiding paths 90a and 90b may not be provided.

The drug container 4 used in the drug administration device of the present invention includes a container main body 41 having an opening, a sealing member 42 for sealing the opening of the container main body 41, and a drug 43 stored in the container main body 41. Is provided.
The container main body 41 may be anything as long as it has an opening and can store the medicine 43 therein. For example, a rigid or semi-rigid synthetic resin container, a glass container, or the like is used. Moreover, it is preferable that the inside of a chemical | medical agent container is pressure-reduced. The sealing member 42 that seals the opening may be any member as long as it can puncture (pierce) with the second needle portion 71b of the hollow needle of the puncture device 7. Examples of the sealing member 42 include rubber having elasticity (for example, butyl rubber, latex rubber, silicone rubber, styrene-butadiene rubber, isoprene rubber, and the like), synthetic resin (for example, styrene such as SBS elastomer, SEBS elastomer, and SEPS elastomer). It is preferable to use olefin-based elastomers, olefin-based elastomers such as ethylene-α-olefin copolymer elastomers, and the like.
As the medicine, any medicine such as powder medicine, freeze-dried medicine, solid medicine, liquid medicine, etc. can be used as long as it can be dissolved in the medical liquid 18 (specifically, a solution) filled in the outer cylinder 10. It may be anything. Examples of drugs include vitamins (general vitamins), various amino acids, antithrombotics such as heparin, insulin, antibiotics, antitumor agents, analgesics, cardiotonic agents, intravenous anesthetics, antiparkinson agents, and ulcer treatments Agents, corticosteroids, arrhythmic agents, hormone preparations, interferon preparations, human immunoglobulin preparations, blood coagulation factor preparations, vaccine preparations, and other protein preparations.

  In the above-described embodiment, the adapter main body may be the adapter main body 20a shown in FIGS. The adapter main body 20a does not have an adapter outer cylinder and an adapter inner cylinder unlike the adapter main body 20 described above, and is constituted by one member, and the upper portion 21 of the adapter main body 20a is formed by the adapter inner cylinder described above. 8 has the same configuration as the upper portion having the guide path, and the lower portion 22 has the same configuration as the lower portion having the medicine container connecting portion 61 of the adapter outer cylinder 6. In addition, the upper part 21 of the adapter main body 20a is provided with the guide path and protrusion with which the adapter inner cylinder mentioned above is provided. The configuration is the same as described above. Moreover, the structure of the chemical | medical agent container connection part in the lower part 22 is also the same as what the adapter outer cylinder mentioned above equips.

Next, the operation of the drug administration device of the present invention will be described with reference to FIGS. 1, 3, 17 to 20.
As shown in FIG. 1, the drug administration device of the present invention is in a state where the adapter 2 is mounted on the drug container 4, and the prefilled syringe 3 and the plunger 5 are not mounted. Note that the medicine container 4 may not be attached to the adapter 2 but may be attached at the time of use.
In the initial state, as shown in FIG. 3 and described above, the puncture device 7 is accommodated in the adapter body 20 (adapter inner cylinder 8), and the projecting portions 73a and 73b are puncture device introduction paths 84a and 84b. The movement in one direction is restricted by the puncture tool detachment restricting projections 87a and 87b of the puncture tool introduction paths 84a and 84b, and the movement in the circumferential direction (rotation of the puncture tool 7) is guided in the circumferential direction. The passages 86a and 86b are restricted by the puncture tool rotation restricting protrusions 88a and 88b, and are not substantially moved.
Then, by inserting the prefilled syringe 3 into the puncture device 7 from the cap 30 side and rotating the prefilled syringe 3, the cap-side screwing portion 34 provided on the outer surface of the cap 30 and the cap mounting portion 74 of the puncture device 7. The state shown in FIG. 17, in which the puncture device side threaded portion provided on the puncture device 7 is screwed, and the first needle portion 71 a of the hollow needle 71 of the puncture device 7 pierces the seal member 32 of the cap 30. Become. In this state, the hollow needle 71 and the prefilled syringe 3 communicate with each other.

When the prefilled syringe 3 is rotated, as shown in FIG. 18, the puncture device 7 follows the prefilled syringe 3, and the projections 73a and 73b of the puncture device 7 get over the puncture device rotation restricting projections 88a and 88b. Then, the circumferential guide paths 86a and 86b are moved. In the rotation operation of the prefilled syringe 3, when the protrusions 73a and 73b of the puncture device 7 completely get over the puncture device rotation restricting projections 88a and 88b, the resistance decreases, and thus one operation ends. Can be recognized.
Then, by pushing the prefilled syringe 3 toward the lower end side in the axial direction, the puncture device 7 follows and tilts down the inclined guiding paths 90a and 90b of the axial guiding path, and the second needle portion 71b of the hollow needle 71 is reached. Inserts into the sealing member 42 of the drug container 4. Further, by pushing the prefilled syringe 3 toward the lower end side in the axial direction, the puncture device 7 descends (moves in the other end direction) on the second guide paths 85a and 85b, and the second needle portion 71b of the puncture device 7 The sealing member 42 of the medicine container 4 is completely pierced. When the protrusions 73a and 73b of the puncture device 7 come into contact with the puncture tool movement restriction projections 89a and 89b, the resistance increases, and further, by pushing the prefilled syringe, the protrusions 73a and 73b of the puncture device 7 are pushed. However, when the puncture tool movement restricting projections 89a and 89b are overcome, the resistance decreases, and the protrusions 73a and 73b are brought into contact with the terminal ends of the second guide paths 85a and 85b as shown in FIGS. . In the pressing operation of the prefilled syringe, the end of the connecting operation of the medicine container by the puncture device can be easily recognized by the increase in resistance and the subsequent decrease.

  And in the state of FIG. 20, the inside of the prefilled syringe 3 and the inside of the medicine container 4 are in communication. When the plunger 5 is attached to the prefilled syringe 3 and the plunger 5 is pushed in, the medical liquid (drug solution) in the prefilled syringe 3 moves into the drug container 4 as shown in FIG. Then, the medicine container 4 into which the medical liquid is injected is shaken, the medicine in the medicine container 4 is dissolved, and the medicine preparation is performed. Then, the plunger 5 is pulled and the prepared medicine 19 is sucked into the syringe 3. Thereafter, the prefilled syringe 3a that has sucked the prepared medicine 19 is rotated and detached from the adapter 2 (puncture device 7), whereby the state shown in FIG. 22 is obtained. Thereby, the medicine preparation operation is completed.

DESCRIPTION OF SYMBOLS 1 Drug preparation tool 2 Adapter 3 Prefilled syringe 4 Drug container 5 Plunger 6 Adapter outer cylinder 7 Puncture tool 8 Adapter inner cylinder 73a, 73b Puncture tool side engaging part 84a, 84b Puncture tool introduction path 85a, 85b Axial direction guide path 86a, 86b Circumferential guide passages 90a, 90b Inclination guide passages 87a, 87b Puncture detachment restricting projections 88a, 88b Puncture rotator restricting projections 89a, 89b Puncture implement movement restricting projections

Claims (10)

To the nozzle part that conforms to the ISO standard while sealing the opening of the tip part by an outer cylinder having an opened tip part and a sealing member that is attached to the tip part of the outer cylinder and can be pierced by a hollow needle A cap that cannot be connected to a medical device having a connecting portion; a slidable gasket housed in the outer cylinder; a pusher that can be attached to the rear end of the gasket; A prefilled syringe made of filled medical liquid, a container body having an opening, a sealing member that seals the opening of the container body and is pierced by a hollow needle, and is housed in the container body A prescription syringe provided with a medicine container made of the medicine and an adapter connected to the opening sealed by the sealing member, and a medicine preparation tool comprising a medicine container,
The adapter is a cylindrical body penetrating from one end to the other end, the adapter main body having a drug container connecting portion at the other end, and the other inside the adapter main body from the one end side. A puncture device movable in the end direction,
The puncture device includes a puncture device body having a cap attachment portion and a puncture device side engagement portion to which the cap of the prefilled syringe can be attached, and is fixed to the puncture device body, and one end protrudes into the cap attachment portion. A hollow needle having a first needle part capable of piercing the seal member of the cap to be mounted and a second needle part having the other end penetrating the sealing member of the drug container; With
The adapter body includes a guide portion that guides the puncture device side engagement portion of the puncture device from one end side to the other end side, and the guide portion extends in a circumferential direction of the adapter body. An axial direction guiding portion extending in the axial direction of the adapter body from the circumferential direction guiding portion and terminating, and provided in the circumferential direction guiding portion, engageable with the puncture device side engaging portion, and the puncture device A puncture device rotation restricting portion through which a side engagement portion can be forcibly passed; and a puncture device side engagement portion that is provided on one end side of a predetermined length from the end of the axial guide path and is engageable with the puncture device side engagement portion. A pharmaceutical preparation tool, comprising: a puncture device movement restricting portion for restricting the movement of the puncture device after passing through the joint portion. 2. The drug preparation device according to claim 1, wherein the axial direction guiding portion includes an inclination guiding portion that extends in an axial direction and obliquely with respect to the adapter main body, provided in a portion continuous with the circumferential direction guiding portion. The puncture device side engaging portion is a protruding portion provided on an outer surface of the puncture device main body, and the guide portion of the adapter main body houses the protruding portion of the puncture device and the protruding portion at one end. The drug preparation tool according to claim 1 or 2, wherein the drug preparation tool is a guide path that leads from the side to the other end side. The guide path includes a puncture tool introduction path that extends from one end of the adapter body to the other end side, and a circumferential guide path that forms the circumferential direction guide portion that extends in the circumferential direction of the adapter body from the puncture tool introduction path; The drug preparation device according to claim 3, further comprising an axial guide path that extends in the axial direction of the adapter body from the circumferential guide path and forms the axial guide section that terminates. The puncture device side engagement portion is a protrusion provided on the outer surface of the puncture device main body, and the puncture device introduction path of the adapter main body houses the protrusion of the puncture device, and the protrusion Is a puncture device guide path for introducing the puncture device into the circumferential direction guide portion, and the puncture device introduction path projects inward from the wall surface of the puncture device introduction path so that the projection portion of the puncture tool can be overcome. 5. The drug preparation tool according to claim 4, further comprising a puncture tool withdrawal restricting protrusion. The puncture device is housed in the adapter main body so that the protruding portion of the puncture device is located at the terminal portion of the puncture device introduction path, and the movement of the puncture device in the other end direction is the puncture device Restricted by the bottom of the introduction path, movement in one end direction is regulated by the puncture tool detachment regulating projection, movement in the circumferential direction is regulated by the puncture tool rotation regulating part of the circumferential guide path, and substantially The drug preparation tool according to claim 5, wherein The adapter main body is a cylindrical body that penetrates from one end to the other end, an adapter outer cylinder having a drug container connecting portion at the other end, and a cylindrical body that penetrates from one end to the other end, the adapter outer cylinder The medicine preparation tool according to any one of claims 1 to 6, comprising an adapter inner cylinder housed in the adapter, wherein the guide section is provided in the adapter inner cylinder. When the puncture device side engaging portion of the puncture device moves the axial direction guide portion of the adapter in the other end direction, the puncture device is configured such that the second needle portion of the puncture device is the drug container. The pharmaceutical preparation tool according to any one of claims 1 to 7, wherein the sealing member is pierced. The medicine preparation tool according to any one of claims 1 to 8, wherein the cap is attached to the outer cylinder so as not to be detached. The drug preparation device according to any one of claims 1 to 9, wherein the distal end portion of the outer cylinder cannot be connected to a medical device having a connection portion to a nozzle portion conforming to ISO standards.

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