JP2011194045A - Medicine administration appliance - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medicine administration appliance whose prefilled syringe is detachable from an adapter after an inside of the prefilled syringe and an inside of a medicine container in which the medicine is contained are communicated with each other.SOLUTION: The medicine administration appliance 1 comprises the prefilled syringe 2 with a cap 5, the medicine container 4, and the adapter 3. The adapter includes a tubular adapter body 30 and a puncture appliance 6 having an outer-tube side puncture part 62 and a medicine-container side puncture part 63. The prefilled syringe is rotatable in the adapter and movable in a direction of the puncture appliance, and the cap 5 and the adapter 3 include a rotation regulating mechanism to restrain the rotation of the cap in the adapter when the prefilled syringe 2 is rotated in the adaptor 3, while the inside of the prefilled syringe 2 and the inside of the medicine container 4 are communicated with each other.

Description

  The present invention relates to a drug administration device using a prefilled syringe.

Conventionally, a drug in powder form or the like is sealed in a vial, and if necessary, a drug solution is mixed and dissolved by a syringe to create a drug solution, and the powder drug can be administered. As a method for producing such a drug solution, an injection needle attached to a nozzle portion of an outer cylinder of a syringe using a syringe filled with a drug solution in an outer cylinder is sealed with a vial containing a powdered drug. Insert the plunger of the syringe in the direction of the nozzle at the tip of the outer cylinder, feed the drug solution into the vial, dissolve and mix the powdered drug in the vial to make a drug solution, and then reinsert the plunger of the syringe into the base of the syringe. The drug solution created in the outer cylinder of the syringe is inhaled by pulling in the end direction so that the drug solution can be administered.
However, the operation for producing these chemicals is time-consuming and has the risk of contamination with foreign substances, contamination with bacteria, and injury to hands and fingers.

  In order to solve such problems, Japanese Patent Application Laid-Open No. 5-146510 (Patent Document 1) discloses a drug container in which a dissolving drug is accommodated and the mouth is sealed with a stopper, and the neck of the drug container. A connection outer cylinder fitted on the outer part, a protective cylinder fitted on the other end of the connection outer cylinder, a cylindrical solution container filled with a solution stored inside the protection cylinder, and an outer connection There has been proposed a press-injection type container that can be melted at the time of use, which is composed of a double-sided puncture needle that is fitted through a drug container side end wall of a connecting inner cylinder fitted inside the cylinder.

  Japanese Patent Laid-Open No. 10-323389 (Patent Document 2) discloses a syringe outer cylinder filled with a solution, a cylindrical adapter having a vial mounting portion at one end, an open cylinder adapter at both ends, a syringe outer cylinder, and a vial. Consists of a double-ended needle communicating with the vial attached to the attachment part, and the adapter is accommodated and supported near the vial attachment part, and a syringe outer cylinder is slidably inserted from the other end. A two-component mixing solution-filled syringe has been proposed in which the distal end portion is closed with a rubber cap, the proximal end portion is sealed with a gasket, and a communication sequence control means is configured between the double-ended needle and the adapter. Yes.

JP-A-5-146510 Japanese Patent Laid-Open No. 10-323389

However, a liquid filled with medical liquid (for example, a solution) in the outer cylinder of the syringe may be overlooked as an administrable drug solution and may be administered in a state where the drug is not dissolved. In addition, it is difficult to easily recognize whether or not the puncture device communicates with the inside of the outer cylinder of the syringe and the inside of the medicine container, and the plunger of the syringe is operated while both are not in communication with each other. There is also a risk of leakage of the drug solution.
Therefore, the object of the present invention is to allow the prefilled syringe to be detached from the adapter after the inside of the prefilled syringe filled with the medical liquid and the inside of the medicine container containing the medicine are communicated, and in a state where no medicine is added. The present invention provides a drug administration device that can prevent erroneous administration of only liquid.

What achieves the above object is as follows.
(1) an outer cylinder having a nozzle portion provided at a distal end portion, a cap that seals the nozzle portion and has a puncturable portion, and is detachably attached to the outer cylinder by screwing; A gasket slidably accommodated in the outer cylinder; a plunger attached to or attachable to the gasket; a prefilled syringe comprising medical liquid filled in the outer cylinder; and an opening. A medicine administration device comprising a container body, a seal part for sealing the opening, a medicine container made of medicine stored in the container body, and an adapter connectable to the opening side of the medicine container. Because
The adapter is a cylindrical body that penetrates from one end to the other end, and is movable in the other end direction from the one end side in the adapter main body having a drug container connecting portion at the other end. There is an outer cylinder side puncture part that is disposed at a position that is the other end side with a predetermined length from the opening on the one end side, and can pierce the puncturable part of the cap and the seal part of the drug container A hollow needle-like portion having a drug container-side puncture portion capable of communicating with the outer cylinder-side puncture portion, and a puncture device having a base portion to which the hollow needle-like portion is fixed,
The prefilled syringe is in a state where the cap is mounted by being accommodated in the adapter, and the cap is capable of rotating the cap in the adapter body and moving in the direction of the puncture device. With side protrusions,
Further, the cap and the adapter are configured such that the prefilled syringe is pushed into the drug container side, the outer cylinder side puncture portion of the puncture device pierces the puncturable portion of the cap, and the drug container side puncture portion of the puncture device is the drug When the prefilled syringe is rotated in the adapter in a state where the seal portion of the container is pierced and the prefilled syringe and the drug container communicate with each other or the prefilled syringe is pushed into the drug container side A drug administration device comprising a rotation restricting mechanism that is engageable and suppresses rotation of the cap in the adapter.

(2) The rotation restricting mechanism is provided on the cap side rotation restricting portion including a protruding portion or a recessed portion provided on the side protruding portion of the cap or the outer surface of the cap, and on the inner surface of the adapter main body. The drug administration device according to (1), which is configured by an adapter-side rotation restricting portion including a concave portion or a projecting portion extending in the axial direction and adapted to the side rotation restricting portion.
(3) The drug administration device according to (1) or (2), wherein the adapter main body includes a removal prevention unit that prevents the cap from being detached from the adapter main body.
(4) In the above (1) to (3), the outer cylinder includes an outer cylinder side screwing portion, and the cap includes a cap side screwing portion screwed with the outer cylinder side screwing portion. The drug administration device according to any one of the above.

(5) The adapter includes a movement restricting protrusion that contacts the side protrusion of the cap and restricts movement of the prefilled syringe in the puncture device direction. The drug administration device according to any one of the above (1) to (4), which can be released by rotation of the prefilled syringe.
(6) The drug administration device according to any one of (1) to (5), wherein the adapter is attached to the drug container.
(7) The adapter main body includes a movement restricting portion that abuts on the base portion of the puncture device that can and can be overcome, and restricts movement of the puncture device, and the rotation restriction mechanism includes the puncture device. The drug administration device according to any one of (1) to (6), wherein the drug can be engaged after the movement is restricted by the movement restricting portion of the adapter body.

  According to the drug administration device of the present invention, the prefilled syringe is in a state where the cap is mounted by being accommodated in the adapter, and the cap can rotate within the adapter body and move in the direction of the puncture device. The side protrusion part which makes it possible is provided, and even if it rotates a prefilled syringe, detachment | leave from a cap is impossible. Then, by moving the prefilled syringe provided with the cap in the direction of the puncture tool in the adapter, the outer cylinder side puncture portion of the puncture device punctures the puncturable portion of the cap, and further, the prefilled syringe provided with the cap is attached to the adapter. By moving in the direction of the puncture tool, the puncture tool moves in the direction of the drug container together with the prefilled syringe, the drug container side puncture part pierces the seal part of the drug container, and the drug container and the prefilled syringe communicate with each other. The cap and the adapter are configured so that the outer tube side puncture portion of the puncture device pierces the puncturable portion of the cap and the drug container side puncture portion of the puncture device pierces the seal portion of the drug container, and then the prefilled syringe is inserted into the adapter. It is possible to engage when it is rotated and equipped with a rotation regulating mechanism that suppresses the rotation of the cap in the adapter body, and after the inside of the medicine container and the inside of the prefilled syringe communicate with each other, by rotating the prefilled syringe, The prefilled syringe can be detached from the cap. For this reason, the prefilled syringe cannot be detached from the adapter until the inside of the prefilled syringe and the inside of the medicine container containing the medicine are communicated, and only the medical liquid to which no medicine is added is prevented from being erroneously administered.

FIG. 1 is a partially broken front view showing an embodiment of the drug administration device of the present invention. FIG. 2 is a partial enlarged cross-sectional view of the drug administration device shown in FIG. FIG. 3 is an explanatory diagram for explaining the operation of the drug administration device shown in FIGS. 1 and 2. FIG. 4 is an explanatory diagram for explaining the operation of the drug administration device shown in FIGS. 1 and 2. FIG. 5 is an explanatory diagram for explaining the operation of the drug administration device shown in FIGS. 1 and 2. FIG. 6 is an explanatory diagram for explaining the operation of the drug administration device shown in FIGS. 1 and 2. 7 is an enlarged bottom view of the cap of the drug administration device shown in FIG. FIG. 8 is an enlarged sectional view taken along line XX of FIG. FIG. 9 is an enlarged cross-sectional view taken along line YY in FIG. FIG. 10 is a partially enlarged cross-sectional view of a drug administration device according to another embodiment of the present invention.

Hereinafter, the drug administration device of the present invention will be described based on the embodiments shown in the drawings.
The drug administration device 1 of the present invention has an outer cylinder 20 having a nozzle portion 22 provided at a tip portion, a nozzle portion 22 sealed and a puncturable portion 52, and further screwed into the outer cylinder 20 A cap 5 detachably mounted, a gasket 8 slidably housed in the outer cylinder 20, a plunger 7 mounted on or attachable to the gasket 8, and a medical use filled in the outer cylinder 20. A prefilled syringe 2 composed of a liquid 27, a container body 41 having an opening, a seal part 42 for sealing the opening, and a drug 43 stored in the container body 41; It is the chemical | medical agent administration tool which consists of the adapter 3 connectable to the opening part side.

The adapter 3 is a cylindrical body penetrating from one end to the other end, and can be moved from the one end side to the other end direction in the cylindrical adapter main body 30 having the drug container connecting portion 31 at the other end ( The outer cylinder side puncture portion 62 that is disposed at a position that is the other end side of the predetermined length from the opening on one end side and that can pierce the puncturable portion 52 of the cap 5 and the seal portion of the drug container 4 And a puncture device 6 having a hollow needle-like portion having a drug container-side puncture portion 63 that can pierce 42 and communicate with the outer cylinder-side puncture portion 62 and a base portion 61 to which the hollow needle-like portion is fixed. .
The prefilled syringe 2 is in a state of being attached to the adapter 3 when the cap 5 is housed in the adapter 3, and the cap 5 can rotate in the adapter body 30 and move in the direction of the puncture tool 6. The side protrusion part 53 which can be made (slidable) is provided.
Furthermore, the cap 5 and the adapter 3 push the prefilled syringe 2 into the drug container 4 side, the outer cylinder side puncture part 62 of the puncture device 6 penetrates the puncturable part 52 of the cap 5, and the drug container side puncture part of the puncture tool 6 63 pierces the seal portion 42 of the medicine container 4 and the prefilled syringe 2 is inserted into the adapter 3 in a state where the inside of the prefilled syringe 2 and the inside of the medicine container 4 are in communication or further when the prefilled syringe 2 is pushed into the medicine container 4 side. And a rotation restricting mechanism that suppresses the rotation of the cap 5 in the adapter 3.

In the drug administration device of this embodiment, the adapter of the cap 5 is applied by the rotation restricting mechanism in a state where the inside of the prefilled syringe 2 and the inside of the drug container 4 are in communication or further when the prefilled syringe 2 is pushed into the drug container 4 side. By rotating the prefilled syringe 2 while the rotation in the main body 30 is suppressed, the prefilled syringe 2 can be detached from the cap 5 and pulled out from the adapter 3.
Moreover, in the medicine administration device 1 of the illustrated embodiment, as shown in FIG. 1, the medicine container 4 is attached to the adapter 3 to which the prefilled syringe 2 is attached.

As shown in FIGS. 1 and 2, the drug administration device 1 of the present invention includes a prefilled syringe 2 sealed with a cap 5, an adapter 3, and a drug container 4. And the adapter 3 consists of the cylindrical adapter main body 30 and the puncture tool 6 which can move the inside of the adapter main body 30, as shown in FIG. 1 and FIG.
The prefilled syringe 2 is sealed by the outer cylinder 20, the cap 5 that seals the nozzle portion 22 (tip portion) of the outer cylinder 20, the gasket 8 housed in the outer cylinder 20, and the cap 5 and the gasket 8. It consists of medical liquid 27 stored (filled) in the outer cylinder 20.
As shown in FIGS. 1, 2, and 6, the outer cylinder 20 includes a main body portion 21, a nozzle portion 22, and a collar 23.

The nozzle portion 22 is provided at the distal end of the main body portion 21 of the outer cylinder 20 and includes a distal end opening for discharging a chemical solution or the like in the outer cylinder, and is formed so as to decrease in diameter in a tapered shape toward the distal end. Has been. The collar 23 is formed in a cylindrical shape concentrically with the nozzle portion 22 so as to surround the nozzle portion 22. The collar 23 is open at the tip, and the inner diameter and outer diameter of the collar 23 are substantially the same from the base end to the tip. In addition, the tip of the nozzle portion 22 protrudes from the tip opening of the collar 23, and the tip of the nozzle portion 22 and the collar 23 is chamfered so that the nozzle portion 22 and the collar 23 can be easily accommodated in the cap 5. ing.
On the inner peripheral surface of the collar, there is formed a thread groove (outer cylinder side screwing portion) for screwing with a screw thread (cap side screwing portion) formed on the outer peripheral surface of the nozzle housing portion of the cap 5. Thereby, the outer cylinder 20 and the cap 5 are screwed between the collar inner peripheral surface and the nozzle housing portion outer peripheral surface. The nozzle portion 22 can be attached with an injection needle (a hub of the injection needle).

As shown in FIGS. 1 and 6, the outer cylinder 20 has a flange 24. The flange 24 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 20. The flange 24 includes two gripping portions facing each other as shown in FIGS. 1 and 6, and a plurality of ribs are formed on the distal end surface side of the gripping portion.
The outer cylinder 20 is a cylindrical body made of a transparent or translucent material and, if necessary, a material having little oxygen permeability and water vapor permeability.
Examples of the material for forming the outer cylinder 20 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.
The nozzle portion 22 of the outer cylinder 20 is sealed by a cap 5 described later.

As shown in FIGS. 1, 4, and 6, the gasket 8 includes a main body portion extending at substantially the same outer diameter, and a plurality of annular ribs (two or two or more in this embodiment) provided on the main body portion. If necessary, the number of the ribs may be appropriately set as long as the liquid-tightness and the slidability are satisfied. The ribs are in liquid-tight contact with the inner surface of the outer cylinder 20. Further, the front end surface of the gasket 8 has a shape corresponding to the inner surface of the front end of the outer cylinder 20 so as not to form a gap as much as possible when contacting the inner surface of the front end of the outer cylinder 20.
Examples of the material for forming the gasket 8 include elastic rubber (for example, butyl rubber, latex rubber, silicone rubber, styrene-butadiene rubber), thermoplastic elastomer (for example, styrene elastomer such as SBS elastomer, SEBS elastomer, SEPS elastomer, It is preferable to use an olefin-based elastomer such as an ethylene-α-olefin copolymer elastomer).
The gasket 8 is provided with a recess extending inward from the rear end thereof, and this recess serves as a plunger mounting portion. Specifically, the plunger mounting portion has a female screw shape, and can be screwed with a male screw portion formed on the outer surface of the protruding portion 72 formed at the distal end portion of the plunger 7. The plunger 7 is mounted on the gasket 8 by screwing them together.
The medical liquid 27 filled in the prefilled syringe 2 contains a drug solution such as distilled water for injection, physiological saline, and aqueous glucose solution, and further contains a drug (for example, vitamins and minerals), It may be a chemical solution capable of dissolving the powder preparation in the drug container.

As shown in FIG. 2, the cap 5 seals the main body 50 having the opening 50a, the nozzle storage 51, the collar storage 54, the side protrusion 53 protruding in the radial direction, and the opening 50a. And a sealing member 52 that forms a puncturable portion.
The nozzle storage 51 is provided in the center of the cap 5 and has a cylindrical shape with an open end. The inner diameter of the nozzle storage portion 51 is made slightly larger than the nozzle portion 22 and is slightly tapered from the distal end to the proximal end toward the proximal end, so that the entire nozzle portion is accommodated from the proximal opening. ing.
The seal member 52 is housed in a nozzle housing section in the main body section 50, seals the opening 50a, and seals the tip opening of the nozzle section 22 of the outer cylinder 20 in a liquid-tight manner. The seal member 52 is preferably an elastic member so that the tip opening of the nozzle portion 22 of the outer cylinder 20 can be liquid-tightly sealed and the outer tube side puncture portion of the puncture device can be pierced. 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.
Further, on the outer surface of the nozzle housing portion 51, a screw thread (cap side screwing portion) 55 for screwing with a screw groove (outer tube side screwing portion) 25 formed on the inner surface of the collar 23 of the outer tube 20. Is formed. Thereby, the outer cylinder 20 and the cap 5 are screwed between the outer surface of the nozzle storage portion and the inner surface of the collar.
The color storage portion 54 is a cylindrical body that is formed so as to surround the nozzle storage portion 51 and has a closed end, and stores the collar 23 between the inner surface of the color storage portion and the outer surface of the nozzle storage portion. Further, the color storage portion 54 formed in a cylindrical shape is concentric with the nozzle storage portion 51, and the inner diameter of the color storage portion 54 is substantially the same from the tip to the base end.

The cap 5 includes a plurality of side protrusions 53 extending in the radial direction, as shown in FIGS. 2 and 7. In this embodiment, a plurality of side protrusions 53 are provided so as to extend in the vicinity of the end of the cap 5, specifically, in the side direction from the outer periphery of the base end of the color storage portion. The radius of the circle formed by the outer peripheries of the plurality of side protrusions 53 is slightly smaller than the inner diameter of the adapter main body 30. For this reason, the cap 5 can be stored in the adapter body 30, can be rotated in the adapter body 30, and can slide. In this embodiment, the cap 5 includes four side protrusions protruding in a wing shape. The number of the side protrusions is not limited to this, and is preferably about 2 to 8, particularly 3 to 5. Further, the plurality of side protrusions are preferably formed so as to be equiangular with respect to the central axis of the cap 5. Further, the shape of the side protrusions may be any as long as it forms the protrusions.
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.

Next, the adapter 3 will be described with reference to FIGS. 1 to 6.
The adapter 3 is a cylindrical body that penetrates from one end to the other end, and is slidable from the one end side toward the other end in the adapter main body 30 having the drug container connecting portion 31 at the other end. And a puncture device 6 disposed at a position on the other end side of the predetermined length from the opening on the one end side.
The cylindrical adapter main body 30 is a cylindrical body with one end and the other end opened, and the whole has substantially the same inner diameter. A drug container connecting portion 31 is formed at the proximal end portion of the cylindrical adapter body 30. The medicine container connecting portion 31 accommodates one end side portion including the opening of the medicine container sealed by the seal portion 42. In addition, the inner diameter of the adapter main body 30 excluding the other end where the diameter is increased is smaller than the outer diameter of the main body of the drug container 4, and hinders the penetration of the main body of the drug container 4. . For this reason, the medicine container 4 can enter the adapter main body 30 until the main body comes into contact, and cannot enter further. The adapter main body 30 also includes an engaging portion for suppressing detachment of the medicine container attached to the medicine container connecting portion 31. Specifically, the inner surface of the drug container connecting portion 31 of the adapter main body 30 is provided with a protrusion 36 that protrudes inward and engages with the lower part of the opening of the drug container (the lower part of the neck part of the drug container). The projecting portion 36 constitutes an engaging portion.

  The puncture tool 6 is a member that is accommodated in the adapter main body 30 and is movable (slidable) in the adapter main body from the one end side to the other end direction. The puncture device 6 has a disc-shaped main body part (base part) 61 and a hollow needle-like part whose central part is fixed to the main body part. The hollow needle-like portion extends in the direction of the cap 5 from the main body portion 61, extends from the main body portion 61 in the direction of the drug container 4, and extends from the main body portion 61 in the direction of the drug container 4. It has a medicine container side puncture part 63 that can pierce the seal part 42 of the container 4. The outer cylinder side puncture portion 62 and the medicine container side puncture portion 63 communicate with each other inside. The outer cylinder side puncture portion 62 includes a blade edge that can pierce the seal member 52 of the cap 5, and the drug container side puncture portion 63 has a blade edge that can pierce the seal portion 42 of the drug container 4. Further, the hollow needle-like portions (the outer cylinder side puncture portion 62 and the drug container side puncture portion 63) extend substantially parallel to the central axis of the adapter main body 30. The puncture device 6 is disposed at a position where the drug container 4 attached to the adapter main body 30 does not come into contact with the drug container side puncture portion 63 of the hollow needle-like portion. Specifically, as shown in FIG. 2, the puncture device 6 is provided in the adapter 3 so that the drug container side puncture portion 63 of the puncture device 6 is separated from the seal portion 42 of the drug container 4 to be mounted by a predetermined length. It is stored in. The puncture device 6 is disposed at a position where it does not contact the prefilled syringe 2 attached to the adapter main body 30. Specifically, as shown in FIG. 2, the puncture device 6 is accommodated in the adapter so that the outer tube side puncture portion of the puncture device 6 is separated from the seal member 52 of the prefilled syringe 2 to be mounted by a predetermined length. Has been.

In the drug administration device 1 of the present invention, the cap 5 and the adapter 3 push the prefilled syringe 2 into the drug container 4 side, and the outer cylinder side puncture portion 62 of the puncture device 6 pierces the puncturable portion 52 of the cap 5, When the prefilled syringe 2 is rotated in the adapter 3 in a state where the drug container side puncture portion 63 of the puncture device 6 pierces the seal portion 42 of the drug container 4 and the prefilled syringe 2 and the drug container 4 communicate with each other. A rotation restricting mechanism that can be engaged and suppresses rotation of the cap 5 in the adapter 3 is provided. Note that the rotation restricting mechanism is not used when the prefilled syringe 2 and the drug container 4 are in a communication state, but in a state where the prefilled syringe 2 is pushed into the drug container 4 side, and the prefilled syringe 2 is moved inside the adapter 3. It can be engaged when rotated.
The rotation restricting mechanism includes a side protrusion portion 53 of the cap 5 or a cap side rotation restricting portion formed of a protruding portion or a recessed portion provided on the outer surface of the cap, and a position on one end side of the predetermined length from the drug container connecting portion 31. It is provided on the inner surface of the adapter main body 30 and is configured by an adapter-side rotation restricting portion formed of a concave portion or a protruding portion extending in the axial direction and adapted to the cap-side rotation restricting portion.
In particular, in the drug administration device of this embodiment, the side protrusion 53 of the cap 5 forms a cap-side rotation restricting portion, and the inner wall protrusion 32 formed on the inner surface of the adapter body 30 forms an adapter-side rotation restricting portion. is doing. As shown in FIG. 8, in the adapter 3, the outer tube side puncture portion 62 of the puncture device 6 penetrates the puncturable portion 52 of the cap 5, and the drug container side puncture portion 63 of the puncture device 6 is the seal portion 42 of the drug container 4. When the prefilled syringe 2 is rotated in the adapter in a state where the prefilled syringe 2 is pushed further into the drug container 4 than the state where the inside of the prefilled syringe 2 and the inside of the drug container 4 communicate with each other, the cap 5 side A rotation restricting portion that can come into contact with the side portion of the protrusion 53 and suppresses the rotation of the cap 5 in the adapter main body 30 is provided.
Specifically, the side protrusion 53 of the cap 5 can enter a recess formed between the inner wall protrusions 32 of the adapter main body 30, and when the prefilled syringe is rotated in this state, the cap 5 The side portion of the side protrusion 53 contacts the side of the inner wall protrusion 32 of the adapter body 30 and further rotation is restricted, so that the screwing of the cap 5 from the prefilled syringe can be released, The outer cylinder can be detached from the cap attached to the adapter 3.

  Further, in this embodiment, as shown in FIG. 8, the inner wall protruding portion 32 is constituted by a plurality of protruding portions protruding from the inner surface of the adapter main body 30. Moreover, the base part 61 of the puncture device 6 is able to get over the inner wall protruding part 32 and engages with the end part (the lower surface of the inner wall protruding part 32) after getting over. The inner diameter formed by the plurality of inner wall protrusions 32 is slightly smaller than the outer diameter of the base 61 of the puncture device 6. As shown in FIG. 2, the inner wall protruding portion 32 has an inclined surface 32 a whose protruding height gradually increases from one end side to the other end side of the adapter main body 30. 32 a guides the engagement between the base portion 61 and the inner wall protruding portion 32. The puncture tool that has moved in the direction of the drug container passes through the inclined surface 32a and gets over the end portion of the inner wall protruding portion 32, thereby engaging with the end surface of the inner wall protruding portion 32. The lower end surface of the inner wall protruding portion 32 (the other side surface of the adapter main body) is an upstanding end surface, abuts on the peripheral edge portion of the base portion 61 of the puncture device 6, and the base portion 61 is detached from the inner wall protruding portion 32. Suppress.

  In this embodiment, the adapter 3 has four inner wall protrusions 32 having a predetermined width. The number of inner wall protrusions preferably corresponds to the number of side protrusions provided on the cap 5 described above. Moreover, as a number of inner wall protrusion parts, about 2-8 are preferable, and 3-5 are especially preferable. In addition, the plurality of inner wall protrusions are preferably formed to be equiangular with respect to the central axis of the adapter main body 30. Furthermore, as shown in FIG. 8, it is preferable that the width of the concave portion 38 formed between the inner wall protruding portions is wider than the width of the inner wall protruding portion as the form of the inner wall protruding portion 32. In particular, the width of the recess 38 formed between the inner wall protrusions is preferably at least twice the width of the inner wall protrusion 32. By doing so, it becomes easy to enter the recess 38 formed between the engaging portions of the side protrusions 53 provided on the cap 5.

Furthermore, the adapter 3 is preferably provided with a movement restricting protrusion 37 that contacts the side protrusion 53 of the cap 5 and restricts the movement of the prefilled syringe 2 in the direction of the puncture device 6. Furthermore, it is preferable that the locking of the side protrusion 53 of the cap 5 by the movement restricting projection 37 can be released by the rotation of the prefilled syringe 2.
Further, in the drug administration device 1 of this embodiment, an inner wall protrusion that is provided at a position that is one end of a predetermined length from the drug container connection portion 31 and that the base portion 61 of the puncture device 6 can get over and engage with the base portion that has passed over. The unit 32 is provided. In this embodiment, when the inner wall protruding portion 32 of the adapter main body 30 and the base portion 61 of the puncture device 6 are engaged, the side portion of the side protruding portion 53 of the cap 5 constituting the rotation restricting mechanism and the adapter main body. 30 can be brought into contact with the side portion of the inner wall protruding portion 32, and the prefilled syringe 2 can be detached from the cap 5. That is, in this embodiment, before the inner wall protruding portion 32 of the adapter main body 30 and the base portion 61 of the puncture device 6 are engaged, the side portion of the side protruding portion 53 of the cap 5 constituting the rotation restricting mechanism and the adapter. The side of the inner wall protruding portion 32 of the main body 30 is not in contact with the cap 5, and the cap 5 is rotatable within the adapter main body 3 (the prefilled syringe 2 cannot be detached from the cap 5). The prefilled syringe 2 can be detached from the cap 5 after the inner wall protruding portion 32 of the main body 30 and the base portion 61 of the puncture device 6 are engaged.
In the drug administration device 1 of the above-described embodiment, the cap-side rotation restricting portion is configured by the side protruding portion 53 of the cap 5, but is not limited thereto, and is separately provided on the outer surface of the cap. You may comprise a cap side rotation control part by the provided protrusion part or recessed part. In this case, the adapter side rotation restricting portion is constituted by a concave portion or a protruding portion extending in the axial direction that is adapted to the cap side rotation restricting portion.

  In the drug administration device 1 of this embodiment, as shown in FIGS. 2 and 9, the adapter main body 30 preferably includes a movement restricting projection 37 of the cap 5 (syringe). By providing such a movement restricting projection 37, it is possible to prevent puncture of the puncturable portion of the cap by the outer tube side puncture portion of the puncture tool due to unintended advancement of the syringe. In the illustrated embodiment, the adapter main body 30 has four movement restricting projections 37 having a predetermined width. The number of movement restricting protrusions preferably corresponds to the number of side protrusions provided on the cap 5 described above. Further, the number of movement restricting protrusions is preferably about 2 to 8, particularly 3 to 5. The plurality of movement restricting protrusions are preferably formed so as to be equiangular with respect to the central axis of the adapter main body 30. Furthermore, as a form of the movement restricting protrusion, as shown in FIG. 9, it is preferable that the width of the movement restricting protrusion is wider than the width of the recess formed between the movement restricting protrusions. In particular, the width of the recess formed between the movement restricting protrusions is preferably half or less of the width of the movement restricting protrusion.

Furthermore, in the adapter 3 of this embodiment, the movement restricting protrusion 37 and the above-described inner wall protruding portion 32 are provided so as to overlap in the axial direction of the adapter main body 30 as shown in FIG. Similarly, in the adapter 3 of this embodiment, the recess formed between the movement restricting projections 37 and the recess formed between the above-described inner wall protrusions 32 are also provided so as to overlap in the axial direction of the adapter main body 30. . Furthermore, it is preferable that the central portion of the movement restricting projection 37 and the central portion of the inner wall protruding portion 32 are arranged so as to be at substantially the same position in the axial direction of the adapter main body 30. Similarly, it is preferable that the central part of the concave part formed between the movement restricting projections 37 and the central part of the concave part formed between the inner wall projecting parts 32 are also at substantially the same position in the axial direction of the adapter main body 30. . In this way, as shown in FIG. 9, by slightly rotating the prefilled syringe 2 locked by the movement restricting protrusion 37, the side protrusion 53 of the cap 5 is positioned between the movement restricting protrusions 37. By entering the recessed portion to be formed and pushing the prefilled syringe in the direction of the medicine container 4 in that state, the side protruding portion 53 of the cap 5 can be easily moved into the recessed portion formed between the inner wall protruding portions 32. Will be able to.
Furthermore, as shown in FIG. 2, the adapter 3 of this embodiment includes a detachment preventing portion 33 provided near the one end side opening. The detachment preventing unit 33 allows insertion of a prefilled syringe equipped with the puncture tool 6 and the cap 5 from the one end side opening. And when the prefilled syringe after insertion moves in the one end side opening direction of the adapter, the detachment preventing portion 33 contacts the side protruding portion of the cap 5 to prevent detachment. As shown in FIG. 2, the detachment preventing portion 33 has an inclined surface 33 a whose protruding height gradually increases from one end side to the other end side of the adapter main body 30, and the inclined surface 33 a The base part 61 of the puncture device 6 and the side protruding part 53 of the cap 5 are guided. The lower end surface (the other end side surface of the adapter main body) of the separation preventing portion 33 is an upstanding end surface and abuts on the peripheral edge portion of the side protrusion 53 of the cap 5.

The drug container 4 used in the drug administration device of the present invention includes a container main body 41 having an opening, a seal part 42 for sealing the opening of the container main body 41, a drug 43 stored in the container main body 41, It consists of a fixing member 45 that fixes the seal member 42.
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 part 42 that seals the opening may be any part as long as it can puncture (pierce) the hollow needle-like part of the puncture device 6 with the drug container side puncture part 63. Examples of the seal portion 42 include elastic rubber (eg, butyl rubber, latex rubber, silicone rubber, styrene-butadiene rubber), synthetic resin (eg, styrene elastomer such as SBS elastomer, SEBS elastomer, and SEPS elastomer, ethylene It is preferable to use an olefin-based elastomer such as an α-olefin copolymer elastomer.
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 27 (specifically, solution) filled in the outer cylinder 20. 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 all the embodiments described above, the puncture device may be as shown in FIG.
In this embodiment, the puncture device 6a is provided with an outer tube 65 provided so as to enclose the drug container side puncture portion 63 of a hollow needle-like portion, and the air between the drug container side puncture portion 63 and the outer tube 65 A distribution passage is formed. Further, the base portion 61 is provided with a passage 67 that forms a part of the air flow passage. One end of the passage 67 is connected to the air flow passage in the outer tube by an opening formed in the side wall of the outer tube 65. Communicate. Further, at the other end of the passage 67, a bacteria-impermeable air-permeable filter 66 is provided. Therefore, the puncture device 6a of this embodiment has an air flow path from the distal end of the outer tube 65 through the outer surface of the drug container side puncture part 63 and the passage 67 of the base part 61 to the germ-impermeable air-permeable filter 66. I have. By providing such an air flow passage, the re-suction operation of the medicine-dissolved medical liquid into the outer cylinder 20 is facilitated.

Next, the operation of the drug administration device of the present invention will be described with reference to FIGS.
As shown in FIG. 1, the drug administration device of the present invention is in a state where a prefilled syringe 2 and a drug container 4 are attached to an adapter 3. Note that the medicine container 4 may not be attached to the adapter 3 but may be attached at the time of use.
In the initial state, as shown in FIGS. 2 and 9, the side protrusion 53 of the cap 5 of the prefilled syringe 2 is locked by the movement restricting protrusion 37 of the adapter 3, and the prefilled syringe The syringe 2 is in a state where movement in the direction of the puncture device 4 is restricted. Further, the prefilled syringe 2 is rotatable in the adapter 3. Note that the prefilled syringe 2 is not detached by the separation preventing portion 33 that can come into contact with the side protrusion 53 of the cap 5.
In the state of FIG. 9, when the prefilled syringe 2 is slightly rotated, the side protrusion 53 of the cap 5 enters the recess formed between the movement restricting projections 37 and can move in the direction of the puncture tool. It becomes. Then, by pushing the prefilled syringe 2 in this state, as shown in FIG. 3, the puncturable portion 52 of the cap 5 is pierced by the outer cylinder side puncture portion 62 of the puncture tool 6, and the inside of the hollow needle-shaped portion is The inside of the prefilled syringe 2 communicates. Further, by pushing the prefilled syringe 2 in the adapter 3 in the direction of the puncture tool (direction of the drug container), the puncture tool 6 is moved in the direction of the drug container 4 by being pushed by the prefilled syringe 2, and the drug container side of the puncture tool 6 The puncture part 63 pierces the seal part 42 of the drug container 4, and the drug container 4 and the prefilled syringe 2 communicate with each other. Moreover, the base part 61 of the puncture tool 6 gets over the inner wall protrusion part 32 of the adapter 3, and both engage to restrict the movement of the puncture tool 6 toward one end of the adapter 3. And when the inside of the medicine container 4 is depressurized, the medical liquid in the prefilled syringe 2 flows into the medicine container 4 by the suction force by the decompression in the medicine container. When the inside of the medicine container 4 is not depressurized, the medical liquid in the prefilled syringe 2 is caused to flow into the medicine container by pressing the plunger 7 of the prefilled syringe 2. In this manner, the drug 43 and the medical liquid 27 are mixed in the drug container 4 to prepare a drug solution.

Then, as shown in FIG. 5, after the medicine container 4 side is set to the upper side, the plunger 7 is pulled, and the prepared medicine liquid 28 in the medicine container 4 is sucked into the outer cylinder 20. Further, in this state, as shown in FIG. 8, the side protrusion 53 of the cap 5 is in a state of entering the recess 38 formed between the inner wall protrusions 32 of the adapter body 30, and the prefilled syringe 2. Is rotated in the direction in which the screwing of the cap 5 and the outer cylinder 20 is released, the side portion of the side protruding portion 53 comes into contact with the side portion of the inner wall protruding portion 32, and the rotation of the cap 5 is restricted. The screwing is released, and the prefilled syringe 2 can be detached from the cap 5 and pulled out from the adapter 3. As shown in FIG. 6, the extracted prefilled syringe is filled with the prepared drug solution 28 and does not have a cap. Thereby, the preparation for administration is completed. Then, if necessary, a medical needle such as an injection needle is connected to the nozzle portion of the outer cylinder.
In the drug administration device of the present invention, the completion of the communication between the prefilled syringe and the drug container is grasped by the resistance when the base portion of the puncture device crosses the engaging portion of the adapter and the disappearance of the resistance due to the completion of the engagement. can do. Further, since the puncture needle portion of the puncture device is not exposed from the adapter, no erroneous puncture occurs during operation.

DESCRIPTION OF SYMBOLS 1 Drug administration device 2 Prefilled syringe 3 Adapter 4 Drug container 5 Cap 6 Puncture device

Claims (7)

An outer cylinder having a nozzle portion provided at a distal end portion, a cap that seals the nozzle portion and has a puncturable portion, and is detachably attached to the outer cylinder by screwing; and the outer cylinder A gasket housed in a slidable manner, a plunger attached to or attachable to the gasket, a prefilled syringe comprising medical liquid filled in the outer cylinder, and a container body having an opening. A medicine administration device comprising a seal part for sealing the opening, a medicine container made of medicine stored in the container body, and an adapter connectable to the opening side of the medicine container. ,
The adapter is a cylindrical body that penetrates from one end to the other end, and is movable in the other end direction from the one end side in the adapter main body having a drug container connecting portion at the other end. There is an outer cylinder side puncture part that is disposed at a position that is the other end side with a predetermined length from the opening on the one end side, and can pierce the puncturable part of the cap and the seal part of the drug container A hollow needle-like portion having a drug container-side puncture portion capable of communicating with the outer cylinder-side puncture portion, and a puncture device having a base portion to which the hollow needle-like portion is fixed,
The prefilled syringe is in a state where the cap is mounted by being accommodated in the adapter, and the cap is capable of rotating the cap in the adapter body and moving in the direction of the puncture device. With side protrusions,
Further, the cap and the adapter are configured such that the prefilled syringe is pushed into the drug container side, the outer cylinder side puncture portion of the puncture device pierces the puncturable portion of the cap, and the drug container side puncture portion of the puncture device is the drug When the prefilled syringe is rotated in the adapter in a state where the seal portion of the container is pierced and the prefilled syringe and the drug container communicate with each other or the prefilled syringe is pushed into the drug container side A drug administration device comprising a rotation restricting mechanism that is engageable and suppresses rotation of the cap in the adapter. The rotation restricting mechanism is provided on a cap side rotation restricting portion including a protruding portion or a recessed portion provided on the side protruding portion of the cap or an outer surface of the cap, and on an inner surface of the adapter body, and the cap side rotation restricting portion is provided. The drug administration device according to claim 1, comprising an adapter-side rotation restricting portion including a concave portion or a protruding portion extending in the axial direction and adapted to the portion. The said adapter main body is a chemical | medical agent administration tool of Claim 1 or 2 provided with the detachment prevention part which prevents the detachment | leave from the said adapter main body of the said cap. The medicine according to any one of claims 1 to 3, wherein the outer cylinder is provided with an outer cylinder side screwing part, and the cap is provided with a cap side screwing part that is screwed with the outer cylinder side screwing part. Administration device. The adapter includes a movement restricting protrusion that contacts the side protruding portion of the cap and restricts movement of the prefilled syringe in the puncture device direction, and the locking by the movement restricting protrusion is the prefilled syringe. The drug administration device according to any one of claims 1 to 4, wherein the drug administration device can be released by rotation of the device. The drug administration device according to any one of claims 1 to 5, wherein the adapter is attached to the drug container. The adapter body includes a movement restricting portion that abuts the base portion of the puncture device that can and can be overcome and restricts the movement of the puncture device, and the rotation restricting mechanism includes: The drug administration device according to any one of claims 1 to 6, which can be engaged after the movement is restricted by the movement restriction portion of the main body.

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