JP5416529B2 - Drug administration device and drug administration device with drug container installed - Google Patents

Drug administration device and drug administration device with drug container installed Download PDF

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JP5416529B2
JP5416529B2 JP2009225637A JP2009225637A JP5416529B2 JP 5416529 B2 JP5416529 B2 JP 5416529B2 JP 2009225637 A JP2009225637 A JP 2009225637A JP 2009225637 A JP2009225637 A JP 2009225637A JP 5416529 B2 JP5416529 B2 JP 5416529B2
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portion
member
puncture member
outer
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JP2011072440A (en
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等 沖原
美緒 廣瀬
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テルモ株式会社
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  The present invention relates to a drug administration device using a prefilled syringe and a drug administration device already loaded with 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.

Further, the applicant of the present application has proposed one disclosed in Japanese Patent Application Laid-Open No. 2007-98109 (Patent Document 2).
The medicine co-infusion apparatus 1 of Patent Document 2 includes an outer cylinder 2 provided with a nozzle portion 22, a gasket 5, a prefilled syringe 10 composed of a filled medicine 8, and a co-infusion needle 3 that can be attached to the nozzle portion. . The nozzle part 22 includes an inner cylinder part 23, an outer cylinder part 24, and an outer rib 25 provided on the outer surface of the outer cylinder part, and the outer diameter of the distal end part of the inner cylinder part and the inner diameter of the distal end part of the outer cylinder part Is 0.5 mm to 1.5 mm, and the inner diameter of the distal end portion of the outer cylinder portion is 2 to 3 mm or 6 to 10 mm. The mixed injection needle 3 includes a needle main body 31, a middle cylinder 38 that can enter between the outer cylinder 24 and the inner cylinder 23 of the nozzle 22, and an inner rib 37 that engages with the rib 25 of the nozzle on the inner surface. And a side hole 36 provided at a position 10 to 25 mm proximal from the distal end of the mixed injection needle 3.

Japanese Patent No. 4216466 JP 2007-98109 A

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.
Moreover, in the thing of patent document 2, although there is no possibility of causing misadministration of only the drug solution in the syringe as in the cited document 1, since only the mixed injection needle is connected, the administration form is infusion. Specific to mixing in a container.
An object of the present invention is to prevent only a medical liquid filled in a prefilled syringe from being administered, to facilitate the operation of connecting the prefilled syringe into a drug container (vial) containing a drug, and The present invention proposes a drug administration device using a prefilled syringe and a drug administration device already loaded with a drug container capable of selecting an administration mode such as direct administration and indirect administration of a medical solution dissolved in a syringe.

What achieves the above object is as follows.
(1) Connection of the medical device having the outer cylinder main body part and the connection part to the nozzle part that is provided at the distal end part of the outer cylinder main body part and that is open at the distal end and conforms to the ISO standard to the connection part. An outer cylinder provided with a nozzle part having an incapable form, a sealing member for sealing the nozzle part, a gasket slidably accommodated in the outer cylinder, and attached to the rear end of the gasket, or A prefilled syringe comprising a pusher that can be attached, a medical liquid filled in the outer cylinder, a container body having an opening, a seal member for sealing the opening of the container body, and the inside of the container body A medicine administration device comprising an adapter connectable to the opening sealed by the sealing member of a medicine container comprising medicine contained in the medicine container, wherein the adapter is provided on one end side and complies with ISO standards. Suitable nozzle A connector comprising: a medical device connection portion connectable to the connection portion of the medical device having a connection portion; and a syringe connection portion provided on the other end side and engageable with the nozzle portion of the prefilled syringe; A hollow needle-like portion having a blade edge portion capable of penetrating the seal member of the drug container at one end; a connector mounting portion provided on the other end side to removably connect the connector; and a center of the hollow needle-like portion A puncture member comprising a cylindrical collar portion encapsulating the other end side from the portion, a drug container mounting portion connectable to the opening sealed by the seal member, and extending from the mounting portion; The hollow needle-like portion of the puncture member comprises a guide member having a hollow needle-like portion storage tubular portion that is movable inward and the collar portion is movable outward, and the puncture member and the guide member are Connector After the syringe is connected, by pushing the syringe, the puncture member advances in the guide member and pierces the seal member of the drug container, and the puncture member and the guide member Is a drug administration device that includes an engagement portion that is engaged after the puncture member completes piercing of the drug container into the seal member and prevents the puncture member from being detached from the guide member.

(2) The guide member is located outward of the hollow needle-shaped portion storage tubular portion, and extends from the drug container mounting portion toward the end of the hollow needle-shaped portion storage tubular portion. An outer guide portion that extends, and the collar portion of the puncture member moves in a gap between the outer guide portion and the hollow needle-like portion storage tubular portion, and the outer guide of the guide member And the puncture member is provided with an engagement portion that is engaged after the puncture member completes puncture of the drug container to the seal member and suppresses detachment of the puncture member from the guide member. The drug administration device according to 1).
(3) The puncture member includes a protruding portion provided on an inner surface of a distal end portion of the collar portion, and the guide member is provided on an outer surface of the hollow needle-like portion storage tubular portion. An axial groove that slidably accommodates the projecting portion and extends in the axial direction of the tubular portion and from the side of the medicine container mounting portion toward the end of the tubular portion for housing the hollow needle-like portion; An engaging portion that is located in the directional groove and on the mounting portion side and is engageable with the protruding portion of the puncture member, and is engaged after the puncture member completes piercing of the drug container into the seal member And the engaging part which suppresses detachment | leave from the said guide member of the said puncture member is comprised by the protrusion part of the said puncture member, and the said engaging part in the said axial groove part of the said guide member. The drug administration device according to (1) or (2) above.

(4) The puncture member includes a protruding portion provided on an inner surface of a tip portion of the collar portion, and the guide member is provided on an outer surface of the hollow needle-like storage cylindrical portion. An axial groove that slidably accommodates the projecting portion and extends in the axial direction of the tubular portion and from the side of the medicine container mounting portion toward the end of the tubular portion for housing the hollow needle-like portion; A circumferential groove portion that is continuous with the directional groove portion, extends in the circumferential direction of the tubular portion, and slidably accommodates the protruding portion of the puncture member, wherein the protruding portion of the puncture member is Said (1) thru | or (3) which is located in the said circumferential groove part, is a state which permitted the movement to the circumferential direction with respect to the said collar part of the said puncture member, and was restricted to the movement to an axial direction. The drug administration device according to any one of 1.
(5) The puncture member rotates the puncture member in the circumferential direction of the hollow needle-like portion storage tubular portion of the guide member, so that the protruding portion of the puncture member is for storing the hollow needle-like portion. The drug administration device according to (4) above, which moves into the axial groove portion of the tubular portion and enables the puncture member to move in the direction of the mounting portion of the guide member.
(6) The outer cylinder includes an outer rib for engagement provided in the nozzle portion, and the connector is formed on the outer cylindrical portion and the outer cylindrical portion, and is engaged with the outer rib for engagement. An inner rib for engagement, and a rotation direction for detaching the protruding portion of the puncture member from the circumferential groove of the guide member, the outer rib for engagement of the nozzle portion of the outer cylinder being the connector The drug administration device according to (5), wherein the rotation direction for engaging the engaging inner rib of the outer cylindrical portion is the same.
(7) The engaging portion that suppresses the puncture member from being detached from the guide member is provided on the inner surface of the outer guide portion on the free end side and on the connector mounting portion side of the puncture member. The drug administration device according to any one of the above (2) to (6), which is constituted by an opening or a recess that engages with the rib.
(8) The two outer guide portions are provided so as to face each other, and the ribs are provided on the inner surfaces of the free end sides, and the puncture member faces the connector mounting portion side. The drug administration device according to (7), which is provided with an opening or a recess that is provided to engage with the rib.
(9) The nozzle portion of the outer cylinder includes an inner cylinder portion protruding outward from a front end surface of the outer cylinder main body portion, an outer cylinder portion provided so as to enclose the inner cylinder portion, An outer rib for engagement provided on an outer surface of the cylindrical portion; and the connector includes an inner cylindrical portion that can enter the inner cylindrical portion of the nozzle portion; The drug administration device according to any one of (1) to (8), further including an outer cylindrical portion having an engagement inner rib that can be engaged with the outer rib.

(10) The difference between the outer diameter of the distal end portion of the inner cylindrical portion of the nozzle portion and the inner diameter of the distal end portion of the outer cylindrical portion is 0.5 mm to 1.5 mm, and the inner diameter of the distal end portion of the outer cylindrical portion Is 2 to 3 mm or 6 to 10 mm.
(11) The connector and the puncture member may include a rotation restricting portion that restricts rotation of the connector attached to the connector attachment portion of the puncture member relative to the puncture member. (10) The drug administration device according to any one of (10).
(12) The puncture member rotates the puncture member in the circumferential direction of the hollow needle-like portion storage tubular portion of the guide member, so that the protruding portion of the puncture member is for storing the hollow needle-like portion. The drug according to any one of (3) to (11), wherein the drug moves into the axial groove portion of the tubular portion, and the puncture member can move in the direction of the mounting portion of the guide member. Administration device.
(13) In the circumferential direction of the collar portion for rotating the puncture member, the outer rib for engagement of the nozzle portion of the outer cylinder is engaged with the inner rib for engagement of the outer cylindrical portion of the connector. The drug administration device according to (12), which is the same as the rotation direction.
(14) The guide member is continuous with the circumferential groove provided on the outer surface of the hollow needle-like storage cylindrical portion, extends to a free end of the hollow needle-like storage cylindrical portion, and the puncture The drug administration device according to any one of (4) to (13), further comprising a guiding axial groove portion that slidably accommodates the protruding portion of the member.
(15) The drug administration according to any one of (1) to (14), wherein the guide member is provided in the drug container mounting portion and includes a slit for imparting easy deformability to the mounting portion. Ingredients.
(16) The medicine administration device according to any one of (1) to (15) above and the medicine container, and the medicine administration device is attached to the medicine container by the medicine container mounting portion. A drug administration device with a drug container already attached.

The drug administration device of the present invention comprises a prefilled syringe that cannot be connected to a medical device having a connection part to a nozzle part that conforms to the ISO standard, and an adapter that has a mounting part to a drug container. A medical device connection portion for connecting to a medical device having a connection portion to a nozzle portion that can connect the nozzle portion of the syringe and conforms to the ISO standard, a connector having a mounting portion to the nozzle portion of the prefilled syringe, and a hollow needle And a guide member having a tubular portion for accommodating a hollow needle-like portion that can move inside the hollow needle-like portion of the puncture member. The puncture member and the guide member connect the syringe to the connector and push the syringe, whereby the puncture member advances in the guide member and pierces the seal member of the drug container. The puncture member and the guide member The member includes an engaging portion that is engaged after the puncture member completes the piercing of the drug container to the seal member and suppresses the puncture member from being detached from the guide member.
In particular, in the drug administration device of the present invention, as a prefilled syringe, it is impossible to connect to a medical device having a connection portion to a nozzle portion conforming to the ISO standard. Since the connection to the injection needle hub and the port of the three-way stopcock is impossible, there is very little possibility that the medical liquid in the prefilled syringe is directly administered. And after attaching the adapter of the medicine administration device of the present invention to the medicine container in which the medicine is stored, the prefilled syringe is attached to the connector of the adapter, and the prefilled syringe is pushed in so that the puncture member advances in the guide member. The medical liquid in the syringe can be injected into the drug container by piercing the seal member of the drug container and then pressing the plunger of the prefilled syringe. Then, by pulling the plunger of the syringe, it is possible to recover the medical liquid (chemical solution) in which the drug is dissolved in the syringe. Furthermore, since the puncture member is prevented from being detached from the guide member by the engaging portion after the puncture member completes the piercing of the drug container to the seal member, the medical liquid is injected into the drug container and into the syringe. Is easy to collect. In addition, since the connector of the adapter is engaged with the nozzle part of the syringe, when the syringe is detached from the adapter, the connector is attached to the nozzle part of the syringe. Can be connected to an injection needle hub or three-way stopcock port, which is a typical administration means, and can be administered by any administration form such as direct administration or indirect administration of the drug-dissolved medical fluid collected in the syringe .

FIG. 1 is an external view of a drug administration device equipped with a drug container using the drug administration device of the present invention. FIG. 2 is a front view of the drug container in a state where the adapter of the drug administration device of the present invention is mounted. FIG. 3 is a right side view of the drug container with the adapter of the drug administration device of the present invention shown in FIG. 2 attached. 4 is a cross-sectional view taken along line AA in FIG. FIG. 5 is an explanatory diagram of an adapter of the drug administration device of the present invention. FIG. 6 is an explanatory diagram of the adapter of the drug administration device of the present invention. FIG. 7 is an explanatory diagram of an adapter of the drug administration device of the present invention. FIG. 8 is a front view of a connector used in the adapter of the drug administration device of the present invention. 9 is a right side view of the connector of FIG. 10 is a cross-sectional view taken along line BB in FIG. FIG. 11 is a bottom view of the connector of FIG. FIG. 12 is a plan view of the connector of FIG. FIG. 13 is a front view of a puncture member used in the adapter of the drug administration device of the present invention. FIG. 14 is a right side view of the puncture member of FIG. 15 is a cross-sectional view taken along the line CC of FIG. FIG. 16 is a plan view of the puncture member of FIG. FIG. 17 is a bottom view of the puncture member of FIG. FIG. 18 is a front view of a guide member used in the adapter of the drug administration device of the present invention. FIG. 19 is a plan view of the guide member of FIG. FIG. 20 is a bottom view of the guide member of FIG. FIG. 21 is an explanatory diagram for explaining the operation of the drug administration device and the drug administration device with the drug container mounted therein according to the present invention. FIG. 22 is an explanatory diagram for explaining the operation of the drug administration device and the drug administration device with the drug container mounted thereon according to the present invention. FIG. 23 is an explanatory diagram for explaining the operation of the drug administration device and the drug administration device with the drug container mounted therein according to the present invention. FIG. 24 is an explanatory diagram for explaining the operation of the drug administration device and the drug administration device with the drug container mounted therein according to the present invention. FIG. 25 is an explanatory diagram for explaining the operation of the drug administration device and the drug administration device with the drug container mounted according to the present invention. FIG. 26 is an explanatory diagram for explaining the operation of the drug administration device and the drug administration device with the drug container mounted thereon according to the present invention. FIG. 27 is an explanatory diagram for explaining the operation of the drug administration device and the drug administration device with the drug container mounted therein according to the present invention.

The drug administration device of the present invention and the drug administration device loaded with a drug container will be described with reference to the embodiments shown in the drawings.
The drug administration device of the present invention includes an outer cylinder main body 31 and a medical device having a connection portion to a nozzle portion that is provided at a distal end portion of the outer cylinder main body portion 31 and that has an open front end and conforms to ISO standards. An outer cylinder 30 including a nozzle part 35 having a configuration incapable of being connected to the connection part, a sealing member 33 for sealing the nozzle part 35, a gasket 34 slidably accommodated in the outer cylinder 30, A prefilled syringe 3 comprising a pusher 32 attached to or attachable to the rear end of the gasket 34, a medical liquid 38 filled in the outer cylinder 30, a container main body 41 having an opening, and a container main body 41 The adapter 2 is composed of a seal member 42 that seals the opening and a medicine 43 accommodated in the container body 41. The adapter 2 can be connected to the opening sealed by the seal member 42 of the medicine container 4.

The adapter 2 is provided on one end side, the medical device connection portion 72 for connecting to a medical device having a connection portion to the nozzle portion conforming to the ISO standard, and the nozzle portion of the prefilled syringe 3 provided on the other end side. A connector 7 provided with a syringe connection portion to which 35 can be engaged, a hollow needle-like portion 62 having a cutting edge portion that can penetrate the seal member 42 of the drug container 4 at one end, and the connector 7 Puncture member 6 including a connector mounting portion 61 that is detachably connected, and a cylindrical collar portion 63 that encloses the other end side from the central portion of the hollow needle-like portion 62, and an opening sealed by the seal member 42 A medicine container mounting part 51 connectable to the part, and a hollow needle-like part storage cylinder extending from the mounting part 51 and having a hollow needle-like part 62 of the puncture member 6 being movable inward and a collar part 63 being movable outward. Part 54 Consisting of Ido member 5.
The puncture member 6 and the guide member 5 connect the syringe 3 to the connector 7 and push the syringe 3 so that the puncture member 6 advances in the guide member 5 and pierces the seal member of the drug container. The puncture member 6 and the guide member 5 are engaged with each other after the puncture member 6 completes the piercing of the drug container 4 to the seal member 42 and suppresses the puncture member 6 from being detached from the guide member 5. ing.
The drug administration device 1 with the drug container mounted according to the present invention includes a drug administration device that does not include the above-described drug container, a container body 41 having an opening, a seal member 42 that seals the opening of the container body 41, and a container. The medicine container 4 has a medicine stored in the main body 41, and the medicine administration tool is attached to the medicine container 4 by the medicine container attaching portion 51.

As shown in FIGS. 1 to 10, the drug administration device 1 with the drug container mounted according to the present invention includes a drug administration device and a drug container 4 to which a drug administration device 5 is connected. The drug administration device of the present invention includes a prefilled syringe 3 that cannot be connected to a medical device having a connection portion to a nozzle portion that conforms to the ISO standard, and an adapter 2 that has a mounting portion to the drug container 4. . As shown in FIGS. 1 to 10, the adapter 2 includes a connector 7 to which the nozzle portion 35 of the prefilled syringe 3 can be connected, a hollow needle-like portion 62, and a puncture member 6 to which the connector 7 can be connected. It comprises a drug container mounting portion 51 and a guide member 5 having a hollow needle-like portion storage tubular portion 54 that can move inside the hollow needle-like portion 62 of the puncture member 6.
FIG. 1 is an external view of a state in which a drug administration device equipped with a drug container using the drug administration device of the present invention is provided. As will be described later, the puncture member 6 has a hollow needle-like portion storage tubular portion 54. The state which cannot move below is illustrated. On the other hand, FIG. 2 shows a front view of the drug container in a state in which the adapter of the drug administration device of the present invention is mounted. Compared to FIG. The state where the puncture member 6 is rotated about 90 degrees with respect to the central axis of the portion 54 and is movable below the hollow needle-like portion storage tubular portion 54 is illustrated.

Initially, the prefilled syringe 3 is demonstrated using FIG. 1, FIG. 23 thru | or FIG.
The prefilled syringe 3 cannot be connected to a medical device having an outer cylinder main body 31 and a distal end of the outer cylinder main body 31 that is open at the distal end and has a connection portion to a nozzle portion that conforms to ISO standards. An outer cylinder 30 having a nozzle portion 35 having a specific shape, a sealing member 33 (specifically, a removable cap) for sealing the nozzle portion 35, and a slidably housed in the outer cylinder 30. The gasket 34 includes a pusher 32 attached to or attachable to the rear end of the gasket 34, and a medical liquid 38 filled in the outer cylinder 30.
The outer cylinder 30 is a cylindrical body made of a transparent or translucent material and, if necessary, a material having low oxygen permeability and water vapor permeability.
The outer cylinder 30 includes an outer cylinder main body portion 31, a nozzle portion 35 provided at the distal end portion of the outer cylinder main body portion 31, and a flange provided at the rear end portion of the outer cylinder main body portion 31.
The outer cylinder main body part 31 is a substantially cylindrical part that accommodates the gasket 34 in a liquid-tight and slidable manner, and the nozzle part 35 is a cylindrical part having a smaller diameter than the outer cylinder main body part 31. Further, the distal end portion (shoulder portion) of the outer cylinder main body portion 31 is tapered toward the nozzle portion 35 in a tapered shape.

As shown in FIGS. 1 and 27, the flange 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 main body portion 31. The flange includes two gripping portions that are wide and face each other, and a plurality of ribs are formed on the tip surface side of the gripping portion. Further, the rear end surface of the flange has a concave portion at the peripheral edge and the outer cylinder rear end portion other than the rib portion.
The nozzle part 35 is in a form incapable of being connected to a medical device having a connection part to the nozzle part conforming to the ISO standard. That is, the nozzle part 35 does not conform to the ISO standard (ISO 594-1: 1986, ISO 594-2: 1986). For this reason, this syringe 3 cannot be connected to a medical device having a connection portion to a nozzle portion conforming to the ISO standard, for example, a hub such as an injection needle, a port of a three-way cock, and the like. For this reason, administration of the medical liquid in the prefilled syringe is extremely difficult.
In the syringe 3 of this embodiment, as shown in FIGS. 23 to 27, the nozzle portion 35 encloses the inner cylinder portion 36 and the inner cylinder portion 36 that protrudes outward from the distal end surface of the outer cylinder main body portion 31. The outer cylinder part 37 provided so that it may perform, and the outer rib 39 for engagement provided in the outer surface of the outer cylinder part 37 is provided.

The nozzle portion 35 does not have the 6% taper adopted by the ISO standard, and is formed narrowly between the outer cylindrical portion 37 and the inner cylindrical portion 36, so that it conforms to the ISO standard having the 6% taper. A medical female connection part (for example, a hub such as an injection needle, a port of a three-way stopcock) cannot be connected. ISO standard-compliant medical female connection means “Matching part of 6% (about 3.43 °) taper of syringe barrel, needle and other medical devices in ISO594-1: 1986-Part 1: General requirements ".
The end of the medical female connector of the standard (ordinary standard) defined in ISO594-1: 1986 has an inner diameter of 4.270 mm to 4.315 mm and an outer diameter of 6.73 mm at the maximum. And in this syringe 3, since the difference of the outer diameter of the front-end | tip part of an inner cylinder part and the internal diameter of the front-end | tip part of an outer cylinder part and the inner diameter of the front-end | tip part of an outer cylinder part are what was mentioned above, Intrusion between the outer cylinder part 37 and the inner cylinder part 36 of the syringe nozzle part 35 of the medical female connection part of the standard specified in ISO594-1: 1986.

Specifically, the inner cylinder portion 36 has a cylindrical shape that does not substantially have a taper. Here, having substantially no taper is a concept including a taper of about 0 to 5.5% (0 to about 3.15 °). Similarly, the outer cylinder portion 37 has a substantially cylindrical shape with no taper. Here, having substantially no taper is a concept including a taper of about 0 to 5.5% (0 to about 3.15 °). And the difference between the outer diameter of the inner cylinder part 36 of the nozzle part 35 and the inner diameter of the outer cylinder part 37 is preferably 0.5 to 1.5 mm, and more preferably 0.6 to 1.0 mm. Is preferred. By doing in this way, the penetration | invasion between the outer cylinder part 37 of the medical female type | mold connection part and the inner cylinder part 36 is prevented. Further, it is preferable that the tip of the inner cylinder part 36 slightly protrudes from the tip of the outer cylinder part 37. The protrusion length is preferably 1.5 mm or less. Further, the axial length of the inner cylindrical portion 36 is preferably about 6.5 to 9.0 mm.
And the outer side rib 39 for engagement is provided in the outer surface of the outer cylinder part. In this embodiment, it is a spiral rib. Specifically, it has two spiral shapes.

Further, the nozzle portion 35 of the outer cylinder 30 is sealed by a sealing member 33. In this embodiment, a removable cap 33 is used as the sealing member. In addition, as a sealing member, the peelable film-like thing which seals the front end surface of the inner cylinder part 36 of the nozzle part 35 may be sufficient.
Examples of the material for forming the outer cylinder 30 include polypropylene, polyethylene, polystyrene, polyamide, polycarbonate, polyvinyl chloride, poly- (4-methylpentene-1), acrylic resin, acrylonitrile-butadiene-styrene copolymer, polyethylene terephthalate. Various resins such as polyesters such as tarates and cyclic polyolefins can be mentioned. Among them, resins such as polypropylene and cyclic polyolefins are preferable because they are easy to mold and have heat resistance. Further, as a material for forming the outer cylinder 30, it is preferable to use a resin having a relatively higher hardness than the cap 33 in order to improve the sealing performance. If it does in this way, when attaching the cap to a nozzle, a cap will stick to a nozzle with screwing operation, and it can improve sealability more.

As shown in FIG. 27, the gasket 34 has a main body portion extending at substantially the same outer diameter, and a plurality of annular ribs provided on the main body portion (in this embodiment, two, two or more liquid-tight If the slidability is satisfied, the number may be appropriately set.) These ribs are in liquid-tight contact with the inner surface of the outer cylinder 30. Further, the front end surface of the gasket 34 has a shape corresponding to the inner surface of the front end of the outer cylinder 30 so that a gap is not formed as much as possible when contacting the inner front end of the outer cylinder 30.
As a material for forming the gasket 34, elastic rubber (for example, butyl rubber, latex rubber, silicone rubber, styrene butadiene rubber), synthetic resin (for example, styrene elastomer such as SBS elastomer and SEBS elastomer, ethylene-α olefin) It is preferable to use an olefin-based elastomer such as a copolymer elastomer).

The gasket 34 is provided with a recess extending inward from the rear end thereof. The recess has a female screw shape, and is a male screw portion formed on the outer surface of the protruding portion formed at the distal end portion of the pusher 32. And can be screwed together. The pusher 32 is not detached from the gasket 34 by screwing them together. The pusher 32 may be removed and attached at the time of use.
As described above, the pusher 32 includes a protruding portion that protrudes in a cylindrical shape at the tip, and a male screw is formed on the outer surface of the protruding portion. The pusher 32 includes a main body portion extending in the axial direction having a cross-shaped cross section, a pressing disk portion provided at the rear end portion, and a rib provided in the middle of the main body portion.
The medical liquid 38 filled in the prefilled syringe 3 contains a drug solution such as distilled water for injection and physiological saline, and further contains a drug (for example, vitamins and minerals). It may be a chemical solution capable of dissolving the powder formulation.

Next, the connector 7 will be described with reference to FIGS. 4 to 12, 24 and 27.
As shown in FIGS. 4 to 12, 24, and 27, the connector 7 is provided on one end side, and is connected to a medical device having a connection portion to a nozzle portion that conforms to the ISO standard. 72 and a syringe connecting portion provided on the other end side and engageable with the nozzle portion 35 of the prefilled syringe 3.
As shown in FIGS. 4 to 12, the connector 7 includes a main body 71, a cylindrical medical device connection portion 72 protruding from the main body portion 71, and provided inside the main body portion. And an inner cylinder portion 76 that extends in the opposite direction. The medical device connection portion 72 can be connected to a medical device having a connection portion to a nozzle portion that conforms to the ISO standard. Specifically, the medical device connection portion 72 is a nozzle portion having a 6% taper conforming to ISO594-1, and is a medical female connection portion conforming to the ISO standard (for example, a hub such as an injection needle, three-way A stopcock port) can be connected.

A syringe connection portion is formed in the main body portion 71. The inner cylinder part 76 can accommodate the inner cylinder part 36 of the nozzle part 35 of the syringe 3, as shown in FIGS. It has become.
As shown in FIGS. 4 to 12, the main body 71 is a cylindrical outer cylinder that encloses the inner cylinder 76, and includes a flange 73 at the end. Further, the outer cylinder part 37 of the nozzle part 35 of the syringe can be accommodated between the main body part 71 and the inner cylinder part 76. On the inner surface of the base end portion (flange side portion) of the main body portion 71, an engagement inner rib 75 that engages with the engagement outer rib 39 provided on the outer surface of the outer cylinder main body portion 31 of the nozzle portion 35 of the syringe 3. I have. In this embodiment, the engagement inner rib 75 has a short spiral shape corresponding to the spiral form of the engagement outer rib 39. Further, as shown in FIG. 10, two engagement inner ribs 75 are provided so as to face each other. The main body portion 71 includes a window portion 77 provided on a side surface and extending from the distal end (nozzle side) of the main body portion 71 to a predetermined long base end side (flange side). In this embodiment, two window parts 77 are provided so as to face each other, and the inner cylinder part 76 is visible from the outside. Further, the main body portion includes a flat portion 74 provided on the side surface, a rib 78 provided on the end portion (flange side), and slits 79 provided on both sides of the flat portion 74, which will be described later. The connector mounting portion 61 is provided with a mounting portion. For this reason, in the drug administration device 1 of this embodiment, the connector 7 and the puncture member 6 restrict the rotation of the connector 7 attached to the connector attachment portion of the puncture member 6 with respect to the puncture member 6. And by providing said mounting part, rotation of the connector with which the connector mounting part 61 of the puncture member 6 was mounted | worn is controlled and careless detachment | leave is prevented. In this embodiment, the connector is such that the flat portion 74, the rib 78 provided on the end portion (flange side) of the flat portion 74, and the slit 79 provided on both sides of the flat portion 74 face each other. Two are provided.

Next, the puncture member 6 will be described with reference to FIGS. 4 to 7, 13 to 17, 24 and 27.
The puncture member 6 has a hollow needle-like portion 62 having a cutting edge portion that can penetrate the seal member 42 of the drug container 4 at one end, a connector mounting portion 61 that is provided on the other end side and removably connects the connector 7; And a cylindrical collar portion 63 that encloses the other end side of the center portion of the hollow needle-like portion 62.
The connector mounting portion 61 is a short cylindrical portion, and a hollow needle-like portion 62 extends a predetermined length from one end thereof, and a flange 64 is provided at the other end portion. Well. Further, the hollow needle-like portion 62 has a smaller outer diameter and inner diameter than the connector mounting portion 61.
The connector mounting portion 61 detachably accommodates a portion excluding the vicinity of the flange portion of the connector 7 inside. When the connector 7 is attached to the puncture member 6, the medical device connection part (nozzle part) 72 enters the proximal end part of the hollow needle-like part 62 as shown in FIGS. 4 to 7. Yes. In addition, a seal member 99 is disposed in the connector mounting portion 61 so as to be narrowed between the two when the connector 7 is mounted on the puncture member 6. For this reason, the connector 7 is liquid-tightly attached to the puncture member 6. As shown in FIG. 4, the liquid-tight state between the connector 7 and the puncture member 6 is formed by the inner surface of the proximal end portion of the hollow needle-like portion 62 and the medical device connecting portion (nozzle that has entered the proximal end portion). Part) 72 may be formed by contact between the outer surfaces. Moreover, the connector mounting part 61 is provided with the flat part 95 provided in the side surface inner side, as shown in FIG. In this embodiment, two flat portions 95 are provided so as to face each other. Further, the flat portion 95 has a flat outer surface as well as an inner surface. Furthermore, a slot (opening) 69 is provided at the end (flange side) of the flat portion 95. The slot 69 is engaged with a rib 78 provided at the end of the flat portion 74 of the connector. In this embodiment, two slots 69 are also provided so as to face each other.
Furthermore, the puncture member 6 includes a slot (opening) 67 provided on the hollow needle-like part side of the connector mounting part 61. In this embodiment, two slots 67 are provided so as to face each other. A rib 98 is provided on the base end side (flange side) of the slot 67. The rib 98 penetrates into the window 77 when the connector 7 is attached to the puncture member 6, and engages with the side wall of the window 77. In this embodiment, the ribs 98 are inclined ribs that are higher on the slot 67 side and lower toward the base end side (flange side). Two ribs 98 are provided so as to face each other.

The collar part 63 is a cylindrical body that encloses the other end side from the center part of the hollow needle-like part 62. Specifically, the collar portion 63 extends from the end portion of the connector mounting portion 61 in parallel with the hollow needle-like portion 62 and toward the blade edge of the hollow needle-like portion 62, and the central portion of the hollow needle-like portion 62 is It ends at a position slightly beyond. In this embodiment, the puncture member 6 includes a protruding portion 96 provided on the inner surface of the distal end portion of the collar portion 63. In this embodiment, two protrusions 96 are provided so as to face each other. Further, the collar portion 63 includes a window portion 65 that extends from the protruding portion in the direction of the connector mounting portion 61 by a predetermined length (specifically, substantially up to the connector mounting portion 61). In this embodiment, two window portions 65 are provided so as to face each other.
In this embodiment, as shown in FIGS. 4 and 13 to 17, the hollow needle-like portion 62 includes a first region having a taper angle that forms an acute blade edge portion from the tip side, and the first region. A second region that has a smooth taper angle or substantially no taper angle, a third region that is continuous with the second region and has a taper angle larger than the taper angle of the second region by a predetermined angle, It is preferable to have a fourth region that is continuous with the third region and has no gentle taper angle or substantially no taper angle.
The taper angle (taper expansion angle) of the first region is preferably 90 ° or less, and the length is preferably 2.0 to 5.0 mm. The taper angle (taper spread angle) of the second region is preferably 0 ° to 10 °, and the length is preferably 5.0 to 20.0 mm. The taper angle (taper spread angle) of the third region is preferably 20 ° to 90 °, the length is preferably 2.0 to 5.0 mm, and the starting end of the third region is the tip of the hollow needle-like portion. It is more preferably 10 to 25 mm on the base end side. The taper angle (taper divergence angle) of the fourth region is preferably 0 ° to 10 °, and the length is preferably 10 to 20 mm.
And the side hole 62a is provided in the front-end | tip part of a hollow needle-like part, specifically, the side surface of a blade edge | tip part, and the inside of a hollow needle-like part and the exterior are connected.

Next, the guide member 5 will be described with reference to FIGS. 1 to 7, 18 to 20, and FIGS. 24 to 26.
The guide member 5 has a medicine container mounting portion 51 that can be connected to the opening sealed by the seal member 42, and extends from the mounting portion 51, and the hollow needle-shaped portion 62 of the puncture member 6 is located on the inner side and the collar portion 63. Has a hollow needle-like portion storage tubular portion 54 that can move outside.
The medicine container mounting portion 51 is a short cylindrical portion having a relatively large diameter, and can accommodate the opening portion of the medicine container sealed by the seal member 42 therein. Further, the side part of the medicine container mounting part 51 is provided with a claw part 58 that protrudes inward and engages with the lower part of the opening part of the medicine container (the lower part of the neck part of the medicine container). The upper side of the claw portion 58 of the drug container mounting portion 51 (the hollow needle-like portion storage tubular portion side) is a window portion 89. In this embodiment, a slit 81 for imparting easy deformability to the mounting portion 51 is provided. In this embodiment, the slit 81 extends from the lower end of the mounting portion to the upper side (the hollow needle-like portion storing tubular portion side) on both sides of the claw portion and the window portion. In this embodiment, two sets of the claw portion 58, the window portion 89, and the slit 81 are provided so as to face each other. Specifically, four slits 81 are provided as shown in FIG. 20, and the slit 81 reaches the upper surface of the drug container mounting portion 51 and further extends a predetermined length in the facing slit direction. Yes. In this embodiment, the slit 81 is provided with box-shaped side portions 55 and 56 on the side of the medicine container mounting portion 51, and functions as an operation portion when the guide member 51 is attached to the medicine container 4. To do.

The hollow needle-shaped portion storage tubular portion 54 is a tubular portion having the same outer diameter that protrudes from the central portion of the upper surface of the drug container mounting portion 51. In this embodiment, the guide member 5 is provided on the outer surface on the opening end side of the hollow needle-like portion storage tubular portion 54, and is axial in the hollow needle-like portion storage tubular portion 54 and on the drug container mounting portion 51 side. Further, an axial groove 86 is provided that extends in the end (free end) direction of the hollow needle-like-accommodating tubular portion 54 and slidably accommodates the protruding portion 96 of the collar portion 63 of the puncture member 6. . In this embodiment, an engaging rib 87 is provided which is located in the axial groove 86 and on the mounting portion 51 side and can be engaged with the protruding portion 96 of the puncture member 6. In this embodiment, the engaging portion that prevents the puncture member 6 from being detached from the guide member 5 is constituted by the protruding portion 96 of the puncture member 6 and the engagement rib 87 in the axial groove portion 86 of the guide member 5. Yes. The engagement rib 87 is a rib-like portion that protrudes from the bottom surface of the groove portion. The projecting portion 96 of the puncture member 6 moves while sliding on the axial groove 86 of the hollow needle-like storage cylindrical portion 54, gets over the engagement rib 87, and enters the axial groove end portion 86a. Engage and prevent puncture member 6 from being detached (retracted).
Further, in this embodiment, the guide member 5 is provided on the outer surface on the opening end side of the hollow needle-like portion storage tubular portion 54, extends in the circumferential direction of the tubular portion 54, and has the protruding portion 96 of the puncture member 6. A circumferential groove 85 is slidably accommodated. The circumferential groove 85 is connected to the end of the axial groove 86 described above. Further, in this embodiment, the guide member 5 is continuous with the circumferential groove portion provided on the outer surface of the hollow needle-like portion storage tubular portion 54 and extends to the free end of the hollow needle-like portion storage tubular portion 54. In addition, a guide axial groove 88 is provided for slidably storing the protruding portion 96 of the puncture member 6. For this reason, it becomes easy to guide the protruding portion 96 of the puncture member 6 to the circumferential groove portion 85 of the hollow needle-like portion storage tubular portion 54 of the hollow needle-like portion storage tubular portion 54. In this embodiment, two axial groove portions 86, engaging ribs 87, circumferential groove portions 85, and guiding axial groove portions 88 are provided at positions facing each other.

In the drug administration device 1 of the present invention, the syringe 3 is connected to the connector 7 and the syringe 3 is pushed in, whereby the puncture member 6 advances in the guide member 5 and pierces the seal member 42 of the drug container 4. The puncture member 6 and the guide member 5 are engaged with each other after the puncture member 6 completes the piercing of the drug container 4 to the seal member 42 and suppresses the puncture member 6 from being detached from the guide member 5. ing.
In the drug administration device 1 of this embodiment, the puncture member 6 includes the protruding portion 96 provided on the inner surface of the distal end portion of the collar portion 63 as described above, and the guide member 5 is a hollow needle-like portion storage cylinder. An axial groove 86 provided on the outer surface of the shaped portion 54, extending in the direction of the mounting portion 51 from the opening end side, and slidably storing the protruding portion 96 of the puncture member 6, and within the axial groove 86 and on the mounting portion 51 side And an engaging rib 87 that is engageable with the protruding portion 96 of the puncture member 6. The engaging portion that suppresses the puncture member from being detached from the guide member is constituted by a protruding portion 96 of the puncture member 6 and an engagement rib 87 in the axial groove portion 86 of the guide member 5.
Further, in this embodiment, the guide member 5 is located outside the hollow needle-like portion storage tubular portion 54 and is in the end direction (free end direction) of the hollow needle-like portion storage tubular portion 54. The outer guide part 52 is provided. The collar portion 63 of the puncture member 6 moves between the outer guide portion 52 and the hollow needle-like portion storage tubular portion 54. The outer guide portion 52 of the guide member 5 and the puncture member 6 are engaged after the puncture member 6 is completed after the drug container 4 has been pierced into the seal member 42 and the puncture member 6 is prevented from being detached from the guide member 5. Part (separation inhibiting engagement part).

Specifically, in this embodiment, the guide member 5 includes an outer guide portion 52 formed of an elastically deformable thin plate member, and a second outer guide portion provided so as to face the outer guide portion 52. 53. The collar portion 63 of the puncture member 6 moves inside the outer guide portion 52 and the outer guide portion 53 and outside the hollow needle-like portion storage tubular portion 54. An engagement rib 52a is provided on the inner surface on the free end side of the outer guide portion 52 (the inner surface on the mounting portion side slightly from the free end). Similarly, an engagement rib 53a is also provided on the inner surface on the free end side of the outer guide portion 53 (the inner surface on the mounting portion side slightly from the free end). 24, the engaging ribs 52a and 53a are engageable with a slot (opening) 69 provided at the end (flange side) of the flat portion 74 of the puncture member 5. . Therefore, in the drug administration device of this embodiment, the engaging portions that suppress the separation of the puncture member from the guide member are the engagement ribs 52a and 53a of the outer guide portions 52 and 53 and the slot (opening portion) of the puncture member 5. 69). As described above, the drug administration device of this embodiment has two sets of configurations as the engaging portion that suppresses the puncture member from being detached from the guide member. Thus, although it is preferable to provide two sets of engaging means, only one of them may be provided. Further, the engaging portion on the puncture member 6 side is not limited to the above-described slot (opening), and may be a recess formed on the outer surface of the puncture member 6. Moreover, the free end side parts 52b and 53b of the outer side guide part 52 and the outer side guide part 53 are the widened part which spreads widely in flat form as shown in FIG.

In the drug administration device 1 of this embodiment, as described above, the puncture member 6 includes the protruding portion 96 provided on the inner surface of the distal end portion of the collar portion 63, and the guide member 5 is accommodated in the hollow needle-like portion. A circumferential groove 85 provided on the outer surface of the tubular portion 54 and an axial groove 86 continuous with the circumferential groove 85, and the protrusion 96 of the puncture member 6 is a circumferential groove 88 of the guide member 5. The puncture member 6 is allowed to move in the circumferential direction with respect to the collar portion 63, and the movement in the axial direction is restricted. For this reason, in this state, the puncture member 6 does not move in the direction of puncturing the seal member 42 of the drug container 4.
In the drug administration device 1 of this embodiment, the puncture member 6 rotates the puncture member 6 in the circumferential direction of the hollow needle-like portion storage tubular portion 54 of the guide member 5, thereby causing the protruding portion of the puncture member 6 to move. 96 moves into the axial groove 86 of the hollow needle-like storage cylindrical portion 54 so that the puncture member 6 can be moved in the direction of the mounting portion 51 of the guide member 5. Further, the rotation direction for moving the protruding portion of the puncture member 6 from the circumferential groove portion of the guide member to the axial groove portion is such that the engaging outer rib 39 of the nozzle portion 35 of the outer tube 31 of the syringe 3 is connected to the outer tube of the connector 7. This is the same as the rotation direction for engaging the engaging inner rib 75 of the shaped portion 71. For this reason, by performing a rotation operation of the syringe, which is an operation of attaching the syringe 3 to the connector 7, the protruding portion of the puncture member 6 is continuously (automatically) changed from the circumferential groove portion of the guide member to the axial groove portion. Transition.

The medicine container 4 includes a container body 41 having an opening, a seal member 42 that seals the opening of the container body 41, and a medicine 43 accommodated in the container body 41.
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. The sealing member that seals the opening may be any member that can puncture (pierce) with the hollow needle-like portion 62 of the puncture member 6. Examples of the sealing member include elastic rubber (for example, butyl rubber, latex rubber, silicone rubber, styrene butadiene rubber), synthetic resin (for example, styrene elastomer such as SBS elastomer and SEBS elastomer, ethylene-α olefin copolymer). It is preferable to use an olefin elastomer such as a polymer elastomer).
Any drug, such as a powdered drug, a lyophilized drug, a solid drug, or a liquid drug, can be used as long as it can be dissolved in a medical liquid (specifically, a solution) filled in the prefilled syringe. It may be. Examples of drugs include vitamins (multivitamins), various amino acids, antithrombotic agents such as heparin, insulin, antibiotics, antitumor agents, analgesics, cardiotonic agents, intravenous anesthetics, antiparkinson agents, and ulcer treatments Agents, corticosteroids, arrhythmic agents and the like.

Next, the operation of the drug administration device of the present invention and the drug administration device loaded with a drug container will be described with reference to FIGS.
In this example, a drug administration device 1 with a drug container mounted thereon is used.
As shown in FIG. 1, the drug administration device 1 with the drug container mounted is provided as a set with the adapter 2 mounted on the drug container 4 and the prefilled syringe 3 mounted with the cap 33 on the nozzle portion. .
Then, as shown in FIG. 21, after removing the cap 33 of the prefilled syringe 3, the nozzle portion of the syringe 3 is inserted into the rear end portion of the connector 7 of the adapter 2. Then, by inserting the nozzle portion of the syringe 3 into the rear end portion of the connector 7 of the adapter 2 and rotating it, the outer rib 39 for engagement provided on the outer surface of the outer cylinder main body portion 31 of the nozzle portion 35 of the syringe 3 and The inner rib 75 for engagement provided on the inner surface of the end of the main body 71 of the connector 7 is engaged, and the prefilled syringe 3 is attached to the adapter 2 and the connector is attached to the tip of the syringe. . Then, by continuing the above rotation operation for mounting the syringe, the connector 7 mounted on the syringe together with the syringe 3 and the puncture member 6 mounted with the connector 7 are slightly rotated (about 90 degrees). Thereby, the protruding portion 96 of the collar portion 63 of the puncture member 6 shifts from the circumferential groove portion 85 of the hollow needle-like portion storage tubular portion 54 of the guide member 5 to the axial groove portion 85. FIG. 22 is an external view of the state, and FIG. 23 is a cross-sectional view of the state. Then, by pushing the syringe 3 in the direction of the drug container 4, as shown in FIG. 24, the syringe 3, the connector 7 and the puncture member 6 advance in the direction of the drug container 4, and the hollow needle-like portion 62 of the puncture member 6 is Then, the seal member 42 of the drug container 4 is pierced, and the tip portion reaches the drug container. Then, by pressing the plunger of the syringe 3, the medical liquid (dissolved solution) in the syringe 3 flows into the drug container. FIG. 25 shows the state. Then, after appropriately performing the mixing operation, as shown in FIG. 26, the drug-dissolved liquid 45 in the drug container is placed in the syringe by pulling the plunger 32 of the syringe 3 with the drug container 4 facing upward. To be recovered. After the puncture member 6 completes the puncture of the drug container 4 to the seal member 42, the protrusion 96 of the puncture member 6 and the engagement rib 87 in the axial groove 86 of the guide member 5 are engaged. Since the detachment of the member 6 from the guide member 5 is suppressed, it is easy to inject the medical liquid into the medicine container and collect it into the syringe. Since the connector 4 of the adapter 2 is engaged with the nozzle portion of the syringe 3, when the syringe 3 is pulled from the adapter 2, the connector 7 is attached to the nozzle portion 35 of the syringe 3 as shown in FIG. Therefore, by using the nozzle portion 72 of the connector 7, it is possible to connect to a syringe hub or a three-way stopcock port which is a general administration means, and the medicine-dissolved medical liquid collected in the syringe can be used. Administration by any administration form such as direct administration and indirect administration is possible.

DESCRIPTION OF SYMBOLS 1 Drug administration device with medicine container mounted 2 Adapter 3 Prefilled syringe 4 Drug container 5 Guide member 6 Puncture member
7 Connector

Claims (16)

  1. Form which cannot be connected to the said connection part of a medical device which has the connection part to the nozzle part which was provided in the front-end | tip part of this outer cylinder main-body part and this outer-cylinder main-body part, and the front-end | tip conformed to the ISO standard. An outer cylinder including a nozzle portion having a sealing member, a sealing member for sealing the nozzle portion, a gasket slidably accommodated in the outer cylinder, and attached to or attachable to a rear end of the gasket A prefilled syringe made of a pusher and a medical liquid filled in the outer cylinder, a container body having an opening, a seal member for sealing the opening of the container body, and the container body are housed in the container body. A drug administration device comprising an adapter connectable to the opening sealed by the seal member of a drug container comprising:
    The adapter is provided on one end side and provided on the other end side of the medical device connection portion connectable to the connection portion of the medical device having a connection portion to a nozzle portion conforming to ISO standards. A connector provided with a syringe connecting part to which the nozzle part can be engaged;
    A hollow needle-like portion having a blade edge portion capable of penetrating the seal member of the drug container at one end; a connector mounting portion provided on the other end side to removably connect the connector; and a center of the hollow needle-like portion A puncture member comprising a cylindrical collar portion encapsulating the other end side from the portion;
    A medicine container mounting portion connectable to the opening sealed by the seal member, and extending from the mounting portion, the hollow needle-like portion of the puncture member being movable inward and the collar portion being movable outward A hollow needle-shaped portion storing cylindrical portion and a guide member,
    The puncture member and the guide member connect the syringe to the connector, and then push the syringe so that the puncture member advances in the guide member and pierces the seal member of the drug container And the puncture member and the guide member are engaged after the puncture member completes the piercing of the drug container to the seal member, and the puncture member is engaged to suppress the detachment of the puncture member from the guide member. A drug administration device comprising a part.
  2. The guide member is located outside the hollow needle-like portion storing tubular portion and extends from the drug container mounting portion toward the end of the hollow needle-like portion storing tubular portion. The collar portion of the puncture member moves in a gap between the outer guide portion and the hollow needle-like portion storage tubular portion, and the outer guide portion of the guide member and the The puncture member is provided with an engagement portion that is engaged after the puncture member completes piercing of the drug container to the seal member and suppresses the puncture member from being detached from the guide member. Drug administration device.
  3. The puncture member includes a protrusion provided on the inner surface of the distal end portion of the collar portion, and the guide member is provided on an outer surface of the hollow needle-like portion storage tubular portion, and the protrusion of the puncture member An axial groove extending in the axial direction of the cylindrical portion and extending from the side of the drug container mounting portion toward the end of the cylindrical portion for storing the hollow needle-like portion, and in the axial groove portion And an engagement portion that is located on the mounting portion side and is engageable with the protruding portion of the puncture member, is engaged after the puncture member completes piercing of the drug container into the seal member, and The engagement portion that suppresses detachment of the puncture member from the guide member is constituted by a protruding portion of the puncture member and the engagement portion in the axial groove portion of the guide member. Or the drug administration device according to 2.
  4. The puncture member includes a protrusion provided on the inner surface of the distal end portion of the collar portion, and the guide member is provided on an outer surface of the hollow needle-like portion storage tubular portion, and the protrusion of the puncture member An axial groove extending in the axial direction of the tubular portion and extending from the side of the medicine container mounting portion toward the end of the hollow needle-shaped tubular portion for accommodating the tubular portion, and the axial groove A circumferential groove that is continuous and extends in the circumferential direction of the tubular portion and slidably accommodates the protruding portion of the puncture member, wherein the protruding portion of the puncture member is in the circumferential direction of the guide member 4. The device according to claim 1, wherein the puncture member is located in the groove portion, allows movement of the puncture member in the circumferential direction with respect to the collar portion, and is restricted in movement in the axial direction. 5. Drug administration device.
  5. The puncture member rotates the puncture member in the circumferential direction of the hollow needle-like portion storage tubular portion of the guide member, so that the protruding portion of the puncture member becomes the hollow needle-like portion storage tubular portion. 5. The drug administration device according to claim 4, wherein the drug administration device is capable of moving in the axial groove portion of the puncture member so that the guide member of the puncture member can move in the direction of the mounting portion.
  6. The outer cylinder includes an engaging outer rib provided in the nozzle portion, and the connector is formed on the outer cylindrical portion and the outer cylindrical portion, and is engaged with the engaging outer rib. A rotation direction for detaching the protruding portion of the puncture member from the circumferential groove portion of the guide member, and the engaging outer rib of the nozzle portion of the outer cylinder is connected to the outer side of the connector. 6. The drug administration device according to claim 5, wherein the direction of rotation is the same as that for engaging with the engaging inner rib of the cylindrical portion.
  7. The engaging portion that suppresses the puncture member from being detached from the guide member is provided on the inner surface on the free end side of the outer guide portion, and on the connector mounting portion side of the puncture member, and the rib The drug administration device according to any one of claims 2 to 6, wherein the drug administration device is configured by an opening or a recess that engages with the device.
  8. Two outer guide portions are provided so as to face each other, and the ribs are provided on the inner surfaces of the respective free ends, and the puncture member is provided so as to face the connector mounting portion side. The drug administration device according to claim 7, further comprising an opening or a recess that engages with the rib.
  9. The nozzle portion of the outer cylinder includes an inner cylinder portion that protrudes outward from a front end surface of the outer cylinder main body portion, an outer cylinder portion that is provided so as to enclose the inner cylinder portion, An outer rib for engagement provided on an outer surface; and the connector includes an inner cylindrical portion that can enter the inner tube portion of the nozzle portion; and the outer rib for engagement on the inner surface that can store the outer tube portion. The drug administration device according to any one of claims 1 to 8, further comprising an outer cylindrical portion having an engaging inner rib that can be engaged.
  10. The difference between the outer diameter of the tip of the inner cylinder part of the nozzle part and the inner diameter of the tip of the outer cylinder part is 0.5 mm to 1.5 mm, and the inner diameter of the tip part of the outer cylinder part is 2 mm. The drug administration device according to claim 9, which is -3 mm or 6-10 mm.
  11. The said connector and the said puncture member are provided with the rotation control part which controls that the said connector with which the said connector mounting part of the said puncture member was mounted | worn rotates with respect to the said puncture member. The drug administration device according to 1.
  12. The puncture member rotates the puncture member in the circumferential direction of the hollow needle-like portion storage tubular portion of the guide member, so that the protruding portion of the puncture member becomes the hollow needle-like portion storage tubular portion. The drug administration device according to any one of claims 3 to 11, which moves into the axial groove portion of the guide member and enables the guide member of the puncture member to move in the mounting portion direction.
  13. The circumferential direction of the collar portion for rotating the puncture member is a rotation direction for engaging the engaging outer rib of the nozzle portion of the outer cylinder with the engaging inner rib of the outer cylindrical portion of the connector. The drug administration device according to claim 12, which is the same.
  14. The guide member is continuous with the circumferential groove provided on the outer surface of the hollow needle-like storage cylindrical portion, extends to the free end of the hollow needle-like storage cylindrical portion, and the puncture member The drug administration device according to any one of claims 4 to 13, further comprising a guide axial groove for slidably storing the protruding portion.
  15. The drug administration device according to any one of claims 1 to 14, wherein the guide member is provided in the drug container mounting portion and includes a slit for imparting easy deformability to the mounting portion.
  16. A drug comprising the drug administration device according to any one of claims 1 to 15 and the drug container, wherein the drug administration tool is mounted on the drug container by the drug container mounting portion. Container-fitted drug administration device.
JP2009225637A 2009-09-29 2009-09-29 Drug administration device and drug administration device with drug container installed Active JP5416529B2 (en)

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JP5670242B2 (en) * 2011-03-29 2015-02-18 テルモ株式会社 Drug preparation tool
FR2975896B1 (en) * 2011-06-06 2014-06-06 Biocorp Rech Et Dev Device for connection between a container and a container, method for assembling and using such a device
JP6255163B2 (en) * 2013-04-05 2017-12-27 テルモ株式会社 Drug preparation tool
WO2016153003A1 (en) * 2015-03-26 2016-09-29 テルモ株式会社 Medical resin-made hollow needle, outer cylinder provided with puncture part, and pre-filled syringe
KR101620090B1 (en) 2015-04-20 2016-05-12 주식회사 티젤바이오 Kit for drug delivery, Apparatus for preparing drug delivery system, and A preparation method of drug delivery system
EP3295918A4 (en) * 2015-05-14 2018-12-12 Nipro Corporation Drug doser and prefilled syringe

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US5060704A (en) * 1990-05-25 1991-10-29 David Bull Laboratories Pty. Ltd. Suction transfer assembly
FR2753624B1 (en) * 1996-09-25 1999-04-16 Connection device, in particular between a container with a pierceable stopper and syringe
US6003566A (en) * 1998-02-26 1999-12-21 Becton Dickinson And Company Vial transferset and method
FR2789369B1 (en) * 1999-02-10 2001-04-27 Biodome Connecting arrangement between a container and a container together and ready to use such a device comprising
FR2815328B1 (en) * 2000-10-17 2002-12-20 Biodome Connecting arrangement between a container and a container together and ready to use such a device comprising
DE102004005435B3 (en) * 2004-02-04 2005-09-15 Haindl, Hans, Dr. Medical transfer device
JP4787647B2 (en) * 2005-09-06 2011-10-05 テルモ株式会社 Drug co-infusion device for medical containers

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