JP2005143677A - Medical fluid container equipped with communication means - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a medical fluid container equipped with a communication means with which a preparation operation of the medical fluid can be performed easily and quickly without a risk of an injury of an operator or generation of coring. <P>SOLUTION: The medical fluid container 10 which has a male lure 11 to connect to a needle at a pointed head, and the communication means 20 which is attached to the pointed head of the medical fluid container 10 and includes a cylindrical guide section 21 with a bottom which can be removably attached by a vial aperture section and a hollow puncture member 23 which is disposed at the center part of the bottom 22 of the guide section 21 to penetrate the bottom 22 are connected by screwing of a female screw 26 at the inside of a connection section 25 of the puncturing member 23 at a distal end side than the bottom 22 and a male screw 12 at the outside of the basal part of the male lure 11. Also, a residue section 28 is connected to the connection section 25 at more distal end side than the female screw 26 through a break section 27 and the residue section 28 is engaged to a flange 13 which is formed at a basal part of the male lure 11 so that he break section 27 is broken when the screwing of the connection section 25 and the male lure 11 is released. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

  The present invention relates to a chemical solution container with communication means in which a chemical solution is filled in advance. More specifically, the present invention relates to a chemical solution container with communication means in which a communication means including a puncture needle that punctures a sealing member at a vial mouth and a vial guide is releasably connected and is filled with a chemical solution in advance.

  Drugs that are difficult to maintain pharmaceutical and medicinal stability when used as liquids have been stored in vials as solid preparations, powder preparations, and lyophilized preparations. It is used by mixing with the solution and preparing it as a liquid.

  For example, in the case of a solid preparation contained in a vial, the solution contained in the vial or ampoule is sucked into a syringe (or a solution injection needle is attached to a so-called prefilled syringe pre-filled with a solution) for injection. The needle is pierced through the rubber stopper of the vial, the solution is injected from the syringe into the vial, the solid preparation is mixed with the solution to prepare the drug solution, and after the drug solution preparation operation is completed, the drug solution is re-aspirated from the vial into the syringe. It was.

  However, since this method using a syringe requires a metal needle for the preparation of the chemical solution, the coring of the rubber stopper is necessary when the operator is injured by the injection needle or when the needle is inserted into the rubber stopper of the vial at an angle. May occur. Moreover, since the operation was complicated above all, it took time to prepare.

  Therefore, there is an invention in which a mounting portion of a puncture needle member is fitted to an injection needle connecting portion of a prefilled syringe sealed in a liquid-tight manner by two front and rear rubber toppers in order to solve the above-described problem. According to the present invention, it is possible to easily and surely inject a solution from a prefilled syringe into a vial filled with a powder preparation or the like, and since a general injection needle (metal needle) is not used, the rubber stopper is thin. There is no risk of injecting a drug solution containing a piece into a patient's body (see Patent Document 1).

JP 2002-78798 A

  Further, the guide means comprises a barrel provided with a puncture needle that can be easily broken at the tip of the injection needle connection portion, a gasket inserted into the barrel, and guide means inserted from the tip of the barrel. There is also an invention in which the puncture needle is broken from the injection needle connecting portion when the needle is rotated relative to the barrel. According to the present invention, there is a case where an operator can perform a chemical solution preparation operation without causing injury or causing coring (see Patent Document 2).

JP 2003-190286 A

  However, in the invention described in Patent Document 1, since the puncture member and the injection needle connecting part are connected only by screwing of the mounting part, the syringe is filled with a chemical solution without using the front rubber stopper, and high-pressure steam sterilization is performed. If it is performed, there is a possibility that the chemical solution leaks from this connecting portion. In order to prevent this problem, the medical solution in the syringe is sealed by the front rubber stopper, but the syringe structure becomes complicated, such as the need to form a tube tip member that forms a bypass on the outer wall surface of the front rubber stopper when used, The manufacturing process is also complicated. Moreover, since the rubber member used as the material of the rubber topper is expensive, the manufacturing cost is also increased. Furthermore, since the vial guide is not provided, it is difficult to puncture the sealing member of the vial mouth, and coring is likely to occur when the puncture member is punctured obliquely with respect to the rubber stopper, and the tip of the puncture member May touch your fingers and become contaminated.

  In the invention described in Patent Document 2, fine particles are generated when the guide means is rotated and the puncture needle is broken from the injection needle connecting portion, and there is no possibility that the fine particles are mixed into the drug solution.

Thus, the present inventors have intensively studied to solve the above-mentioned problems, and have arrived at the present invention. That is, the present invention
(1) It includes a drug solution container having a male luer at the tip thereof to which an injection needle can be connected, and a hollow communication means provided at the tip of the male luer, which can be slidably inserted into the mouth of the vial. A bottomed cylindrical guide portion and a hollow puncture member provided at the center of the bottom surface of the guide portion so as to penetrate the bottom surface, the puncture member including a puncture needle on the distal end side from the bottom surface and a proximal end from the bottom surface A chemical container with communication means having a connecting portion on the side, the connecting portion being connected to the male luer by screwing,
A residual portion is connected to the base end side of the female screw of the connection portion via a fracture portion, the residual portion is engaged with a flange of the male luer base portion, and when the screwing of the connection portion and the male luer is released, A chemical container in which the fracture part breaks;
(2) A bottomed cylindrical guide that includes a chemical container having a male luer at the tip and a hollow communication means provided at the tip of the male luer, the slidable insertion of the mouth of the vial. And a hollow puncture member provided through the bottom surface at the center of the bottom surface of the guide portion, the puncture member having a puncture needle on the distal end side from the bottom surface and a connection portion on the proximal end side from the bottom surface. And the connecting part is a chemical solution container with communication means formed by engagement with the male luer,
The residual portion is connected to the base portion of the connection portion via a fracture portion, and the connection portion is connected to the male luer by engaging the residual portion with a flange of the male luer base portion. A chemical container in which the rupture portion breaks during separation;
(3) The chemical solution container according to (1) or (2), wherein a concentric packing is interposed between a bottom surface of the guide portion and a tip surface of the male luer;
(4) The chemical liquid container is a syringe including a barrel having a male luer at the distal end and an open base end, and a gasket that is liquid-tightly and slidably inserted into the barrel from the base end of the barrel. 1) A chemical container according to any one of (3);
(5) The chemical solution container according to any one of (1) to (3), wherein the chemical solution container is a bottle that has a male luer at a tip and can be easily deformed by pressing;
(6) The chemical solution container according to any one of (1) to (5), which is filled with a chemical solution in advance.

  ADVANTAGE OF THE INVENTION According to this invention, the chemical | medical solution container with a communication means which can perform a chemical | medical solution preparation operation | work simply and in a short time without an operator being injured or generating a coring can be provided. Further, since no metal needle is used, labor for separating the metal needle and the plastic member can be saved.

Next, embodiments of the present invention will be described with reference to the drawings.
FIG. 1 is a longitudinal sectional view of Example 1, and a syringe is employed as a chemical solution container. The chemical solution container and the communication means are connected by screwing.
FIG. 2 is an enlarged longitudinal sectional view of the first embodiment.
FIG. 3 is an enlarged front view of the first embodiment.
FIG. 4 is an enlarged front view of the first embodiment, showing a state in which the communication means is removed leaving a residual portion.
FIG. 5 is an enlarged cross-sectional view of the second embodiment, and the flange of the male luer base is formed of a separate member.
FIG. 6 is an enlarged cross-sectional view of Example 3, in which the chemical solution container and the communication means are connected by engagement.
FIG. 7 is an enlarged cross-sectional view of Example 4, and the flange of the male luer base is formed of a separate member.
FIG. 8 is a vertical cross-sectional view of Example 5, and employs a bottle as a chemical solution container.
FIG. 9 is a longitudinal sectional view showing the state of use of the present invention.

  A first embodiment of the present invention will be described with reference to FIGS. A chemical solution container 1 with communication means shown in FIG. 1 includes a chemical solution container 10 having a male luer 11 to which a syringe needle can be connected at the tip, and a hollow communication means 20 provided at the tip of the drug solution container 10. Reference numeral 20 denotes a bottomed cylindrical guide portion 21 into which a vial mouth portion can be slidably inserted, and a hollow puncture member 23 provided through the bottom surface 22 at the center of the bottom surface 22 of the guide portion 21. Is included. The puncture member 23 has a puncture needle 24 on the distal end side with respect to the bottom surface 22 and a connection portion 25 on the proximal end side with respect to the bottom surface 22, and a female screw 26 inside the base portion of the connection portion 25 is attached to the base portion of the male luer 11. Connection is established by screwing with the external male screw 12. Further, a residual portion 28 is connected to the base end side of the connecting portion 25 further than the female screw 26 via a fracture portion 27, and this residual portion 28 is engaged with the flange 13 formed at the base portion of the male luer 11. In addition, the breaking portion 27 is broken when the connection portion 25 and the male luer 11 are unscrewed.

  The inner surface of the connecting portion 25 may be formed as a female luer that fits the male luer 11 in a liquid-tight manner, but a gap may be formed between the outer surface of the male luer 11 as shown in FIGS. However, in that case, it is preferable that a concentric packing 30 be interposed between the bottom surface 22 of the guide portion 21 and the tip surface 14 of the male luer 11. Thus, when the chemical container with the communication means according to the present invention is sterilized by high-pressure steam, the intrusion of moisture into the container through the gap between the male luer 11 and the connection portion 25 is prevented, or the chemical liquid S leaks from the container inside. Can be prevented. Examples of the packing 30 include an O-ring and a square ring. If the gap between the bottom surface 22 and the tip surface 14 of the male luer 11 is liquid-tight and the drug solution container 10 and the puncture needle 24 can be held in communication with each other, The shape is not particularly limited. Examples of the material of the packing 30 include elastic materials such as butyl rubber, silicone rubber, thermoplastic elastomer, silicone elastomer, etc., but they have been used as medical materials and do not interact with the chemical S contained therein. Any material can be suitably used as long as it does not have a risk of elution into the chemical solution S. As described above, if the male luer and the connection portion are in liquid-tight contact, or if the female screw 26 and the male screw 12 are connected in a liquid-tight manner, it is not necessary to provide the packing 30.

  Here, as the chemical solution container 10, a substantially cylindrical barrel 15 having an open base end having a male luer 11 at the distal end, and a liquid tight and slidable insertion from the base end of the barrel 15 into the barrel 15. This is a syringe-type chemical solution container comprising the gasket 40. At the base end of the barrel 15, a finger hooking flange 16 is formed. Examples of the material for forming the barrel 15 include polyethylene, polypropylene, a mixture of polyethylene and polypropylene, and polyolefin resins such as cyclic polyolefin, but have been used as medical materials such as polycarbonate, methacrylic resin, and polymethylpentene. Any resin can be suitably used as long as it does not interact with the chemical solution S contained in the container and has no fear of elution into the chemical solution S.

  A coupling means such as a female screw 41 is formed at the base end of the gasket 40 so that a male screw 51 provided at the tip of the rod 50 can be coupled. Examples of the material for forming the gasket 40 include elastic materials such as butyl rubber, silicone rubber, thermoplastic elastomer, and silicone elastomer. However, the gasket 40 has been used as a medical material and does not interact with the chemical S contained therein. Any material can be suitably used as long as it does not have a risk of elution into the chemical solution S.

  A male screw 51 is formed at the distal end of the rod 50, and a pressing plate 52 is formed at the proximal end for pressing with a finger when the chemical solution S in the syringe is discharged. As a material for forming the rod 50, polyethylene resin, polypropylene, a mixture of polyethylene and polypropylene, and polyolefin resin such as cyclic polyolefin are most preferable, but polycarbonate, methacrylic resin, polymethylpentene, ABS resin, etc. have been used as medical materials. If it is a thing, it will not specifically limit.

  The communicating means 20 includes a bottomed cylindrical guide portion 21 into which a vial mouth portion can be slidably inserted, and a hollow puncture provided at the center of the bottom surface 22 of the guide portion 21 through the bottom surface 22. The puncture member 23 includes a member 23, and has a puncture needle 24 on the distal end side from the bottom surface 22 and a connecting portion 25 on the proximal end side from the bottom surface. The connecting portion 25 is externally fitted to the male luer 11 of the chemical solution container 10, and the female screw 26 inside the base portion of the connecting portion 25 is screwed with the male screw 12 outside the base portion of the male luer 11. The puncture needle 24 is sealed liquid-tight or air-tightly by a cap 60. As a material for forming the cap 60, elastic materials such as butyl rubber, silicon rubber, thermoplastic elastomer, and silicon elastomer, and plastic materials such as polyethylene, polypropylene, a mixture of polyethylene and polypropylene, cyclic polyolefin, polycarbonate, methacrylic resin, and polymethylpentene. However, any material that has been used as a medical material, does not interact with the chemical solution S contained therein, and has no fear of elution into the chemical solution S can be suitably used. .

  As shown in FIGS. 1 and 2, a flange 13 projecting radially outward in the circumferential direction is integrally formed at the base portion of the male luer 11 of the chemical solution container 10 on the base end side of the male screw 12. Further, a residual portion 28 is connected to the base end side of the connecting portion 25 of the puncture member 23 via a fracture portion 27. The broken portions 27 are thin and thin, and are arranged at equal intervals in the circumferential direction. A claw portion 29 protrudes radially inward from a part of the remaining portion 28 or the entire length in the circumferential direction, and is engaged with the proximal end surface of the flange 13. As a result, when the communication means 20 and the chemical solution container 10 are separated, that is, when the connection portion 25 of the puncture member 23 and the male luer 11 of the chemical solution container 10 are released, the breaking portion 27 is broken and the remaining portion 28 and the claw portion 29 remain on the male luer 11 side. The base end surface of the claw portion 29 is inclined so as to move to the distal end side as it goes radially inward, so that when the connection portion 25 is coupled to the male luer 11, the claw portion 29 is moved from the distal end side. It easily gets over the flange 13 and is engaged with its proximal end face. In addition, when getting over, the residual part 28, the nail | claw part 29, etc. elastically deform radially outward.

  When using the chemical solution container 1 with communication means of Example 1, as shown in FIG. 9, after the vial V is connected to the guide portion 21, the chemical solution S in the chemical solution container 10 is injected into the vial V. Mix with drug D (eg lyophilized formulation) in vial V.

  Next, Embodiment 2 of the present invention will be described with reference to FIG. The second embodiment shown in FIG. 5 is a modification of the first embodiment. The flange 113 is formed separately from the male luer 111 and is fitted in the circumferential groove 117 on the outer surface of the male luer 111. Thereby, even when the flange is difficult to be integrally formed on the base portion of the male luer, the flange can be provided. As the forming material of the flange 113, polyolefin resin such as polyethylene, polypropylene, a mixture of polyethylene and polypropylene, and cyclic polyolefin is most preferable, but it has been used as a medical material such as polycarbonate, methacrylic resin, polymethylpentene, and ABS resin. If it is a thing, it will not specifically limit.

  The flange 113 may be separately molded and then attached to the circumferential groove 117, but may be formed by insert molding.

  Next, Embodiment 3 of the present invention will be described with reference to FIG. The third embodiment shown in FIG. 6 has a configuration in which the male screw 12 and the female screw 26 of the first embodiment are eliminated. Therefore, the communication means 220 and the chemical solution container 210 are connected by the engagement between the flange 213 and the claw portion 229. The furan 213 is integrally formed on the base of the male luer 211 of the chemical solution container 210 so as to protrude radially outward over the entire length in the circumferential direction, and a claw portion is formed from a part of the base of the connection portion 225 or a portion extending over the entire length in the circumferential direction. 229 protrudes radially inward and engages with the proximal end surface of the flange 213. In the third embodiment, it is preferable that a packing 230 for liquid-tightly connecting the male luer and the connection portion is interposed between the bottom surface 222 of the guide portion 221 and the front end surface 14 of the male luer 225.

  Next, Embodiment 4 of the present invention will be described with reference to FIG. The fourth embodiment shown in FIG. 7 is a modification of the third embodiment, in which a flange 313 is formed separately from the male luer 311 and is fitted in a circumferential groove 317 on the outer surface of the male luer 311. Thereby, even when the flange is difficult to be integrally formed on the base portion of the male luer, the flange can be provided. As the material for forming the flange 313, polyethylene, polypropylene, a mixture of polyethylene and polypropylene, and polyolefin resins such as cyclic polyolefin are most preferable, but polycarbonate, methacrylic resin, polymethylpentene, ABS resin, etc. have been used as medical materials. If it is a thing, it will not specifically limit.

  The flange 313 may be formed separately and then attached to the circumferential groove 317, but may be formed by insert molding.

  Further, as in Example 5 shown in FIG. 8, the chemical solution container 410 may be a bottle 415 that is formed of a flexible material such as polyethylene or polypropylene and can be easily deformed by pressing.

It is a longitudinal cross-sectional view of Example 1 of this invention. It is an expanded sectional view of Example 1 of the present invention. It is an enlarged front view of Example 1 of the present invention. It is an enlarged front view of Example 1 of the present invention. It is an expanded sectional view which shows Example 2 of this invention. It is an expanded sectional view showing Example 3 of the present invention. It is an expanded sectional view showing Example 4 of the present invention. It is a longitudinal cross-sectional view which shows Example 5 of this invention. It is a figure which shows the use condition of this invention.

Explanation of symbols

1 Chemical solution container with communication means 10, 110, 310 Chemical solution container 11, 111, 211, 311 Oscillator 13, 113, 213, 313 Flange 14, 214 Tip surface 15 Barrel 20, 220 Communication means 21, 221 Guide portion 22, 222 Bottom surface DESCRIPTION OF SYMBOLS 23 Puncture member 24 Puncture needle 25,225 Connection part 26,41 Female screw 27 Breaking part 28 Residual part 30,230 Packing 40 Gasket 415 Bottle S Chemical solution

Claims (6)

A liquid container having a male luer that can be connected to an injection needle at the tip, and a hollow communication means provided at the tip of the male luer, the communication means being a bottomed tube in which the mouth of the vial can be slidably inserted And a hollow puncture member provided through the bottom surface at the center of the bottom surface of the guide portion, the puncture member being connected to the puncture needle on the distal end side from the bottom surface and the proximal end side from the bottom surface A chemical container with communication means, wherein the connecting portion is connected to the male luer by screwing,
A residual portion is connected to the base end side of the female screw of the connection portion via a fracture portion, the residual portion is engaged with a flange of the male luer base portion, and when the screwing of the connection portion and the male luer is released, A chemical container in which the fracture part breaks. Including a chemical container having a male luer at the tip, and a hollow communication means provided at the tip of the male luer, the communication means having a bottomed cylindrical guide that can be slidably inserted into the mouth of the vial; A hollow puncture member provided through the bottom surface at the center of the bottom surface of the guide portion, the puncture member having a puncture needle closer to the distal end than the bottom surface and a connection portion closer to the proximal end than the bottom surface; A chemical solution container with communication means, wherein the connecting portion is connected to the male luer by engagement,
The residual portion is connected to the base portion of the connection portion via a fracture portion, and the connection portion is connected to the male luer by engaging the residual portion with a flange of the male luer base portion. A chemical container in which the rupture portion breaks during separation.   The chemical | medical solution container of Claim 1 or 2 formed by interposing a concentric packing between the bottom face of the said guide part and the front end surface of a male lure.   4. A syringe comprising a barrel having an open end with a male luer at a distal end and a gasket that is liquid-tightly and slidably inserted into the barrel from the proximal end of the barrel. The chemical | medical solution container in any one of.   The chemical solution container according to any one of claims 1 to 3, wherein the chemical solution container is a bottle that has a male luer at a tip and can be easily deformed by pressing. The chemical solution container according to any one of claims 1 to 5, wherein the chemical solution is previously filled therein.

Images