JP3070044B2 - Infusion container with communication means - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an infusion container. More specifically, dry drugs such as powdered preparations, freeze-dried preparations, and solid preparations, and their solutions are stored in a separated state, and immediately before use, the dry drugs and the solution are mixed aseptically in a container. The present invention relates to an infusion container provided with a communication means for supplying a liquid medicine.

[0002]

2. Description of the Related Art Conventionally, in a medical institution such as a hospital, a dry drug in a drug container such as a vial is dissolved in a dissolving solution (including other drug solutions) such as distilled water, saline, glucose solution, and the like, and is injected by infusion. Used for In such a case, the vial containing the dried drug is connected in series to the flexible container containing the dissolving solution so that it can be used easily,
An infusion container in which these two containers are aseptically connected at the time of use has been proposed (Japanese Patent Publication No. Sho 61-50112).
No. 9;
No. 35642).

[0003] Japanese Unexamined Patent Publication (Kokai) No. 61-501129 discloses a capsule in which a capsule containing a medicine container and a flexible container containing a solution are connected by a tube. The medicine container and the flexible container are communicated by the communication means provided, and the medicine and the solution are mixed aseptically. In addition, Japanese Patent Application Laid- Open No. 2-1277
The capsule disclosed in Japanese Patent Laid-Open Publication No. H11-15064 connects a capsule containing a medicine container to an opening of a dissolving solution container at a joint portion thereof, and interposes communication means having a communication order regulating means on the joint portion side of the capsule. In, after the drug container is pierced by the communication means, the dissolution solution container is pierced and the two containers are communicated,
The drug and the dissolving solution are aseptically mixed, and the one disclosed in Japanese Utility Model Laid-Open Publication No. 63-135842 is a tubular support ring which can be appropriately removed from the seal at the mouth of the dissolving solution container. A double-ended needle is attached to this support ring so as to be slidable up and down. When the double-ended needle is slid downward, the lower needle body pierces the seal portion at the mouth of the solution container. Things.

[0004]

The above-mentioned conventional infusion containers are all integrated with a vial, which is a general distribution form of a dry medicine, as they are, and are highly versatile in that sense. However, these conventional infusion containers include, for example, the infusion container disclosed in Japanese Patent Publication No. 61-501129, which has a large number of parts and requires time and effort to break the breaking member by hand to open the passage. If the member breaks incompletely, the liquid will not pass easily, and it will take time to dissolve,
In addition, the infusion container disclosed in Japanese Patent Application Laid- Open No. 2-1277 has the above-mentioned special features in terms of preventing contamination of the internal medicine and simplifying communication between the medicine container and the solution container. Although it is considerably improved as compared with the infusion container disclosed in Japanese Patent Application Laid-Open No. 61-501129, it has the disadvantage that the parts such as the communication order regulating means are complicated and the number of parts is large as a whole. Kaisho 63-
The infusion container disclosed in Japanese Patent No. 135642 has advantages such as a small number of parts, relatively easy operation, and a compact entire infusion container, but requires a relatively large force for communication. After mixing the solution and the solution, remove the support ring and the double-ended needle, invert the solution container, and connect the infusion set to the seal at the mouth of the solution container after removing the double-ended needle. , And there is a risk that the mixed chemical solution may leak at the time of removing the double-ended needle.

[0005] The present invention has been made in view of the above circumstances, is easy to operate, hassle-free, does not leak the mixed chemical solution, has a small number of parts, and aseptically dissolves the drug. An object of the present invention is to provide an infusion container capable of mixing liquids.

[0006]

SUMMARY OF THE INVENTION In order to solve the above-mentioned problems, the present invention provides a dissolvable liquid container made of a press-deformable synthetic resin having a communication port with a medicine container and a chemical liquid outlet at both ends thereof, A double-ended needle having a puncture needle on each of the upper and lower sides and an engagement portion provided on a hub, a connecting portion between an open end and a communication port outer wall of the lysis solution container, and a partition separating the connecting portion from the open end side Provided a plurality of axially flexible guide rods on the upper surface of the partition wall,
A guide capsule for accommodating the double-ended needle so as to be slidable downward, and a cap for sealing an open end of the guide capsule, wherein the double-ended needle is engaged with a guide rod of the guide capsule at an engagement portion. When the mouth of the medicine container is inserted into the guide capsule, the guide rod is expanded by the mouth and flexes outward, the engaging portion of the double-ended needle is released from the rod, and the double-ended needle is moved downward along the guide rod. The structure which becomes like this is adopted.

[0007]

According to the above construction, the cap is removed from the infusion container, and the medicine container is inserted from the open end of the uncapped guide capsule with its mouth at the top, and the medicine container is pushed down. The rubber stopper at the mouth is pierced with the upper puncture needle of the double-ended needle. At the same time, the guide rod of the guide capsule is pushed outward by the mouth of the medicine container, so that the engagement portion of the double-ended needle is disengaged from the locking groove, and the double-ended needle moves downward together with the medicine container, and the lower puncture needle thereof This pierces the closing membrane of the lysis solution container. Then, the medicine container and the infusion container communicate with each other. Next, the solution is introduced from the dissolution solution container into the medicine container with the medicine container facing down, and the dry medicine and the solution contained in the medicine container are mixed. A drug solution can be prepared. The prepared medicinal solution can be used for infusion treatment or the like by connecting an infusion set or the like to the medicinal solution outlet of the infusion container.

[0008]

Next, an embodiment of the present invention will be described with reference to the drawings. FIG. 1 is a cross-sectional view of an infusion container according to one embodiment of the present invention, FIGS. 2 to 10 are diagrams for explaining main components of the infusion container of FIG. 1, and FIG. FIG. 3 is a plan view of FIG. 2, FIG. 4 is a sectional view of the guide capsule, FIG. 5 is a plan view of FIG. 4, FIG. 6 is a bottom view of FIG. 4, FIG. Is a sectional view of a double-ended needle, FIG. 9 is a plan view of FIG. 8, and FIG. 10 is a sectional view of a cap. FIG.
1 is a diagram for explaining the use of the infusion container of the present invention, wherein (A) shows a state in which a rubber stopper of the medicine container is pierced with a double-ended needle, and (B) shows a medicine container and a solution container. FIG. 7 is a diagram showing a state in which a solution is introduced into a medicine container by communicating with the medicine container.

As shown in FIG. 1, an infusion container C of the present invention comprises a lysis solution container 1, a double-ended needle 2 and a guide capsule 3, and the open end of the guide capsule 3 is a cap 5
Sealed. The dissolving solution container 1 has a communication port 11 closed at both ends by a closing film 12 and a chemical solution outlet 12 sealed by a rubber stopper 14, respectively, and a guide capsule 3 having a guide rod 4 is used to dissolve the dissolving solution. A double-ended needle 2 fixed to the communication port 11 of the container 1 and having an upper puncture needle 22 and a lower puncture needle 23 is accommodated in the guide capsule 3 so as to be slidable downward. The double-ended needle 2 is engaged with the guide rod 4 of the guide capsule 3 at the engagement portion 24, and the medicine container V
When the mouth portion is inserted into the guide capsule 3, the guide rod 4 is pushed and expanded by the mouth portion and flexes outward, the engaging portion 24 of the double-ended needle 2 is disengaged from the guide rod 4, and the double-ended needle 2 moves along the guide rod. To be moved downward. In addition, 6
Is a packing for sealing between the guide capsule 3 and the cap 5.

The solution container 1 is a press-deformable bottle which is usually formed of a relatively soft synthetic resin such as polyethylene, polypropylene or polyester.
As shown in FIG. 3, each end has a communication port 11 and a chemical solution outlet 13, and although not shown in the figure, a dissolving solution such as distilled water, physiological saline, or glucose solution is contained therein. Is housed. The communication port 11 is closed by a thin closing film 12, and an annular coupling groove 17 is formed on an outer wall thereof. The coupling groove 17 is adapted to engage with an annular projection 33 of a coupling portion 32 of the guide capsule 3, which will be described later, as shown in FIG. 1. In the figure, the upper end 18 of the groove is formed as an undercut, and the lower end of the groove is formed. Reference numeral 19 is annularly protruded slightly from the upper end 18. A pair of I-shaped or T-shaped projections 16 may be formed on the shoulder of the solution container 1 on the side of the communication port 11 in the major axis direction of the shoulder of the solution container 1, and in this case, the projections 16 As shown in FIG. 1, it is bonded between connecting legs 34 of a guide capsule 3 described later. The inner diameter of the communication port 11 is equal to or slightly smaller than the outer diameter of the lower puncture needle 23 of the double-ended needle 2.
2 is pierced, the lower puncture needle 23 is inserted into the inner wall of the communication port 11.
Is sealed, so that the drug solution does not leak from the infusion container C after the communication between the drug container V and the solution container 1.

A drug solution outlet 13 is a portion for taking out a drug solution prepared by dissolving a drug with a solution, and a rubber stopper 14 is attached by insert molding. FIGS. 1 and 2 show the rubber stopper 14 protected by a cover member 15 having a knob. At the time of infusion treatment, the cover member 15 may be removed by screwing it off, and an infusion set (not shown) or the like may be connected to the rubber stopper 14. In addition, since a closing film cannot be formed at the chemical solution outlet 13 due to the insert molding, the rubber stopper 14 usually has an inner side laminated with polytetrafluoroethylene or the like.

The guide capsule 3 accurately guides the double-ended needle 2 to the closing film 12 of the communication port 11, and is usually made of a flexible resin such as polyethylene, polypropylene, polyester, polyvinyl chloride, polycarbonate ABS resin, or the like. As shown in FIG. 4 to FIG. 7, the connecting part 32 between the open end 36 and the communication port 11 of the solution container 1 and the partition 31 separating the connecting part from the open end side are formed. Have. The connecting portion 32 is formed concentrically with the shaft on the partition wall 31, and its inner cavity communicates with the open end 36 side. An annular projection 33 that fits into the groove 17 is formed. On the side of the connecting portion 32, the solution container 1 is provided outside the connecting portion 32.
A connecting leg 34 having a bifurcated distal end may be provided corresponding to the projection 16. In this case, the protrusion 16 of the solution container 1 is sandwiched between the connecting legs 34 and is bonded by using a method such as heat welding. On the other hand, on the open end side of the guide capsule 3, a flange 35 is formed on the outer wall, and a plurality of guide rods 4 are formed inside the guide capsule 3 in axisymmetric manner. Flange 3
5 has an open end 36 of the guide capsule 3 as shown in FIG.
Is welded.

A plurality of guide rods 4 are provided on the partition wall 31 in a vertically axisymmetric manner (four are provided in the figure, but are not particularly limited). The diameter of the circle passing through 43 is substantially equal to the outer diameter of the mouth of the medicine container V. An inclined surface 41 that is inclined inward from an inner end 43 is provided at the tip end of the guide rod 4, and a locking groove 42 is formed below the inclined surface 41. As shown in FIG. 1, a bottom portion 27 of an engaging portion 24 of the double-ended needle 2 described below is locked by a step 45 on the lower side of the locking groove 42. When the guide rod 4 moves downward along the inclined surface 41 of the guide 4, the guide rod 4 bends outward, and the bottom 27 is detached from the locking groove 42. The guide rod 4 is provided with an engagement portion 2 of the double-ended needle 2.
4, the double-ended needle 2 is prevented from rotating about its axis, and is accurately guided by the closing membrane 12 of the solution container 1. The step 44 above the locking groove 42 is for preventing the double-ended needle 2 from moving upward.

Double-ended needle 2 housed in guide capsule 3
As shown in FIGS. 8 and 9, the upper puncture needle 22 and the lower puncture needle can be pierced through the rubber stopper at the mouth of the medicine container V and further through the closure membrane 12 of the solution container 1. Needle 2
3 and a hub 21. In order to hold the double-ended needle 2 with the guide rod 4 having a special shape as described above,
An engagement portion 24 is formed on the hub 21. Although not limited in the present embodiment, the hub 21 is formed in a cross shape, and the engaging portion 24 is formed in a U-shape on the outer edge of the cross-shaped hub 21. The double-ended needle 2 is housed in the guide capsule 3 so as to sandwich the guide rod 4 on both sides of the U-shaped engaging portion 24. At this time, the bottom portion 27 of the engaging portion 24 is locked by the step 45 below the locking groove 42 of the guide rod 4. Reference numeral 26 denotes a fluid passage.
Are formed, but the number of fluid passages 26 may be one. Further, in order to improve the stability of the double-ended needle 2 in the guide capsule 3, an upward locking piece 25 may be provided at the tip of the engaging portion 24.

FIG. 10 shows an example of the cap 5. The cap 5 seals the open end 36 of the guide capsule 3 and is made of a synthetic resin such as polyethylene or polypropylene, and has a packing mounting groove 51 and a break 52. The cap 5 is adhered to the flange 35 of the guide capsule 3 by means of, for example, heat welding at an adhesive portion 53 at the lower end thereof. Packing insertion groove 5
1 is a groove formed in an annular shape, and as shown in FIG. 1, a packing 6 is mounted as a seal member between the cap 5 and the guide capsule 3. In addition, the fracture portion 52 is
5 is formed in a thin portion by a V notch or the like at the bonding portion 53 to the fifth member. When the infusion container C is used, the cap 5 is twisted by hand and cut off from the guide capsule 3 at the break portion 52.

Next, the use of the infusion container of the present invention is shown in FIG.
1 will be described. Infusion container C to cap 5 of FIG.
Is removed, and the medicine container V is inserted from the open end 36 of the guide capsule 3 from which the cap 5 has been removed, with the mouth opening the rubber stopper at the top, and this is pressed down, whereby FIG.
As shown in (A), first, a rubber stopper at the mouth of the medicine container V is pierced with the upper puncture needle 22 of the double-ended needle 2. At the same time, the guide rod 4 of the guide capsule 3 is pushed outward by the mouth of the medicine container V, so that the engaging portion 24 of the double-ended needle 2 is disengaged from the locking groove 42, and the double-ended needle 2 is moved downward together with the medicine container V. Then, the closing membrane 12 of the solution container 1 is pierced by the lower puncture needle 23. Thereby, the medicine container V and the solution container 1 communicate with each other. Next, when the infusion container C is inverted (the infusion container C is turned up and the medicine container V is turned down), the solution S is introduced from the solution container 1 into the medicine container V (FIG. 11B )), The dry medicine D contained in the medicine container V is dissolved in the dissolution liquid S. When the dry medicine D is dissolved in the dissolving solution S, the infusion container C is again erected (the infusion container C is lowered), and the dissolution solution S
Is introduced into the solution container 1, the solution container 1 is rubbed by hand or the solution S and the dried drug D are uniformly mixed to prepare a drug solution. When the chemical solution is prepared, the cover member 15 of the chemical solution outlet 13 of the solution container 1
Is twisted and removed, and an infusion set or the like is connected to the exposed rubber stopper 14 of the drug solution outlet 13, the prepared drug solution can be used for infusion treatment or the like.

[0017]

As is apparent from the above description, by employing the infusion container of the present invention, the operation is simple and time-consuming, so that the burden on the operator can be reduced and the labor can be saved. Possible, the number of parts is small, the manufacturing cost is low, the infusion container can be provided at low cost, and the mixed chemical does not leak during the mixing operation.
And the like.

[Brief description of the drawings]

FIG. 1 is a cross-sectional view of an infusion container according to one embodiment of the present invention.

FIG. 2 is a cross-sectional view of the lysing solution container shown in FIG.

FIG. 3 is a plan view of FIG. 2;

FIG. 4 is a sectional view of the guide capsule shown in FIG. 1;

FIG. 5 is a plan view of FIG. 4;

FIG. 6 is a bottom view of FIG. 4;

FIG. 7 is a right side view of FIG.

FIG. 8 is a sectional view of the double-ended needle shown in FIG. 1;

FIG. 9 is a plan view of FIG.

FIG. 10 is a sectional view of the cap shown in FIG. 1.

FIGS. 11A and 11B are diagrams for explaining the use situation of the infusion container of the present invention, wherein FIG. 11A shows a state in which the rubber stopper of the medicine container is pierced with a double-ended needle, and FIG. It is a figure which shows the state which connects a liquid container and introduce | transduces a solution into a medicine container.

[Explanation of symbols]

 C Infusion container V Drug container 1 Dissolution liquid container 11 Communication port 12 Closure membrane 13 Chemical solution outlet 16 Projection 2 Double-ended needle 21 Hub 22 Upper puncture needle 23 Lower puncture needle 24 Engaging part 25 Locking piece 3 Guide capsule 31 Partition 32 Coupling Part 34 connecting leg 4 guide rod 41 inclined surface 42 locking groove 5 cap

────────────────────────────────────────────────── ─── Continuation of the front page (56) References JP-A-4-329956 (JP, A) JP-A-2-1277 (JP, A) (58) Fields investigated (Int. Cl. ⁷ , DB name) A61J 1/05 A61J 1/20 B65D 81/32

Claims (4)

(57) [Claims] 1. A pressurized and deformable synthetic resin solution container having a communication port with a drug container and a drug solution outlet port at both ends thereof, a puncture needle on both upper and lower sides, and an engagement portion provided on a hub. A double-ended needle, a connecting portion between the open end and the outer wall of the communication port of the lysing solution container, and a partition separating the connecting portion from the open end, and a plurality of flexible guide rods extending in the axial direction on the upper surface of the partition. ,
A guide capsule for accommodating the double-ended needle so as to be slidable downward, and a cap for sealing an open end of the guide capsule, wherein the double-ended needle is engaged with a guide rod of the guide capsule at an engagement portion. When the mouth of the medicine container is inserted into the guide capsule, the guide rod is expanded by the mouth and flexes outward, the engaging portion of the double-ended needle is released from the rod, and the double-ended needle is moved downward along the guide rod. Transfusion container provided with communication means configured as described above. 2. A guide rod of a guide capsule is arranged axially symmetrically, an inclined surface and a locking groove are respectively provided at an upper end portion and an intermediate portion thereof, and an engaging portion of a double-ended needle is formed into a U-shape on an outer edge of a hub. The infusion container according to claim 1, wherein the engaging portion is disposed so as to sandwich the guide rod, and engages with a step portion below the locking groove at the bottom of the engaging portion. . 3. The infusion container according to claim 1, wherein a locking piece that comes into contact with the inner wall of the guide capsule is provided at a tip of the engaging portion of the hub. 4. The lysing solution container according to claim 1, wherein a projection is provided on a shoulder portion on a communication port side of the dissolving solution container, and a connecting leg for connecting to the projection is provided outside a connecting portion of the guide capsule. Infusion container.