JP2001112850A - Solution container - Google Patents

Abstract

PROBLEM TO BE SOLVED: To make a double head needle smoothly slidable even by a woman or a child in the vertical direction, and also, easily and safely remove a double head needle-holding cylinder from a container body, and also, facilitate the recycling of the container. SOLUTION: A double head needle-holding cylinder 3 is formed into an internal-external double cylinder structure. Then, a double head needle 2 is smoothly slid along a U-shaped groove 27 between the internal and the external cylinders 26 and 25, in the vertical direction. For the double head needle-holding cylinder 3, a female thread section 28 is provided on the internal cylinder 26. Then, by screwing the female thread section 28 with a male thread section 9 on the mouth section side of a container body 1, the removal from the container body 1 is facilitated. The double head needle 2 and its holding cylinder 3 are formed of a same resin material, and the separation and the sorting of respective sections at the time of recycling can be eliminated.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical dissolution container used for dissolving a drug such as a powder preparation or a lyophilized preparation contained in a vial into a dissolution liquid.

[0002]

2. Description of the Related Art As a conventional technique, for example, in a medical institution such as a hospital, a drug such as a powder preparation or a lyophilized preparation contained in a vial is mixed and dissolved in a dissolving solution such as water for injection or physiological saline. Infusions are given as infusions. At this time, the vial containing the drug and the solution container containing the solution of the drug are aseptically connected using a double-ended needle, and the drug is transferred to the solution in the solution container and dissolved. An infusion container designed to perform such treatment has been proposed (for example, Japanese Utility Model 4).
-22745, JP-A-5-317384 and the like).

As disclosed in Japanese Utility Model Publication No. 4-22745, as shown in FIG. 10, a cylindrical support ring 51 is attached to a seal portion 50 of a mouth portion 4 of a container body 1 containing a solution. The lower end portion is attached by being fitted concentrically with the mouth portion 4, and the support ring 5 is attached to the lower end portion.
1, a double-ended needle 52 is held so as to be slidable up and down. Further, as disclosed in Japanese Patent Application Laid-Open No. 5-317384, as shown in FIG. 11, a cylindrical holding member 54 is attached to a neck 53 of a container body 1 containing a dissolving solution by engaging an engagement projection 55 at the lower end thereof. Attached by mating,
A double-ended needle 55 is held inside the holding member 54 so as to be vertically movable.

[0004]

However, the dissolving solution container with a double-ended needle disclosed in Japanese Utility Model Publication No. 4-22745 is attached to the mouth 4 of the container body 1 so that the support ring 51 can be removed. However, the attachment is performed by strongly fitting the lower end portion of the support ring 51 to the seal portion 50 of the mouth portion 4. For this reason, even if a woman such as a nurse pulls out the support ring 51 from the seal portion 50 of the container body 1 in the disposal treatment before administration or after use, a large pulling force is required, which is very troublesome for the woman. there were. Also,
In the support ring 51 and the double-ended needle 52, a locking projection 58 is formed on the lower end portion of the outer peripheral ring 57 of the double-ended needle 52 so as to protrude outward in order to prevent the double-ended needle 52 from coming out of the support ring 51 upward. The locking projection 58 is integrally formed.
Locking projection 5 integrally formed on the upper end of the support ring 51
9 so that it can be locked in a retaining shape. According to such retaining means, the locking projection 59 at the upper end of the support ring 51 is more thermally contracted than the locking projection 58 of the double-ended needle 52 during the steam sterilization of the solution container with double-ended needle. It was necessary to make it easy to secure retaining and to prevent the infiltration of sterilized water. Therefore, as a material of the double-ended needle 52 and the support ring 51, the support ring 51 needs to be formed of a resin material having a larger heat shrinkage than the double-ended needle 52. However, if the double-ended needle 52 and the support ring 51 are formed of a different material, the double-ended needle 52 and the support ring 51 must be separated and separated for recycling.
2 may cause injuries, and may lead to bacterial infection.

[0005] In the infusion container disclosed in Japanese Patent Application Laid-Open No. Hei 5-317384, the neck 5 of the container body 1 is also used.
3, the holding member 54 of the double-ended needle 56 is attached by fitting the engaging projection 55 at the lower end thereof. Therefore, the holding member 54 is detached from the container body 1 before disposal or after disposal after use. Was not easy for women and girls. Further, in order to make it easier to insert the double-ended needle 56 with a mouth portion or a flange of the vial into the holding member 54, several vertical cuts 60 are made in the holding member 54,
In this case, when the infusion container is subjected to steam sterilization while holding the double-ended needle 56, sterilized water may enter through the cut 60.

SUMMARY OF THE INVENTION Therefore, an object of the present invention is to solve the above-mentioned problems, and it is possible for women and women to easily and safely remove the double-headed needle and its holding cylinder from the container body. It is an object of the present invention to provide a dissolving solution container which can facilitate the up-and-down sliding of a double-ended needle in a needle holding cylinder, achieve stable and reliable operation, and can simplify separation and disposal.

[0007]

According to the present invention, as shown in FIGS. 1 to 9, a container body 1 in which a mouth portion 4 is sealed with a plug 5 made of an elastic material that can be pierced with a needle, In the center of the inside of the ring 16 there is a needle 17
a, 17b integrally formed of resin, a double-ended needle 2, an outer cylinder 25, an inner cylinder 26 continuously formed in a U-shaped cross section inside the lower end of the outer cylinder 25, and the inner and outer cylinders 25,2
And a double-ended needle holding cylinder 3 having an upper open U-shaped groove 27 formed between the inner cylinder 26 and the female screw part 28 provided on the inner periphery of the inner cylinder 26 of the double-ended needle holding cylinder 3. Is screwed into a male screw portion 9 provided on the outer periphery on the mouth side, and the double-ended needle 2 is attached to the U-shaped groove 27
The lower needle 17b of the double-ended needle 2 is pierced through the plug 5 by sliding downward, and the double-ended needle holding cylinder 3 is made of the same resin material as the double-ended needle 2. It is characterized in that it is molded with.

According to the dissolution liquid container having the above structure, when the mouth of the vial containing the medicine is inserted into the upper part of the outer peripheral ring of the double-ended needle and pressed downward, the double-ended needle is moved together with the vial into the double-ended needle holding cylinder. Slides down along the U-shaped groove between the inner and outer cylinders, and the upper and lower needles are pierced into the rubber stopper at the mouth of the vial and the stopper at the mouth of the container body. Communication between the vial and the container body is achieved by piercing the upper and lower needles through the rubber stopper of the vial and the stopper of the container body. Due to the communication between the vial and the container body, the medicine in the vial is
It is transferred to and dissolved in the container body containing the dissolving solution under aseptic conditions without being contaminated by the outside air.

Since the double-ended needle is slid up and down in the U-shaped groove between the inner and outer cylinders of the double-ended needle holding cylinder, a clearance is provided between the outer peripheral ring of the double-ended needle and the inner and outer cylinders to reduce sliding resistance and smoothly. It can be slid up and down lightly and very stably and reliably by the guide action of the inner and outer cylinders. The double-ended needle holding cylinder has the female thread of the inner cylinder screwed into the male thread on the mouth side of the container body, so that women and girls can easily and safely remove the double-ended needle and its holding cylinder from the container body. it can.

Since the double-ended needle and its holding cylinder are formed of the same resin material, after use, the double-ended needle can be discarded and recycled while housed and held in the double-ended needle holding cylinder. This eliminates the need to separate and separate the wastewater, simplifies recycling, and enables safe treatment without injuries caused by double-headed needles, which are likely to occur when separated.

[0011]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS One embodiment of the present invention will be described below with reference to FIGS. FIG. 1 is a vertical sectional front view of a solution container, FIG. 2 is a vertical front view showing the solution container in an exploded state,
3 is an enlarged vertical sectional view of a slide portion of the double-ended needle of the solution container, FIG. 4 is an enlarged vertical sectional view of a screw connection portion between the mouth of the solution container and the double-ended needle holding cylinder, and FIG. FIG. 6 is a vertical sectional front view showing a state immediately before communication between the container body and the vial, FIG. 6 is a vertical sectional front view showing a state where the container body of the solution container is communicated with the vial, and FIG. It is a vertical front view which shows the state which removed the double-ended needle holding cylinder and the vial.

1 and 2, the medical solution container for medical use and the like according to the present invention comprises a container body 1, a double-ended needle 2 and a double-ended needle holding cylinder 3. The container body 1 is a container for containing a solution, and is a flexible container formed of a thermoplastic resin such as soft polypropylene. After the dissolving solution is put into the container body 1, its mouth 4 is sealed with a stopper 5 made of an elastic material that can be pierced with a needle.

As shown in FIGS. 2 and 4, the plug 5 is formed by integrating a rubber plug body 6 with a port 7 and a membrane 8 made of a thermoplastic resin such as soft polypropylene. 5 is heat-welded or ultrasonic-welded to the mouth 4 of the container body 1. The port 7 is formed in a short cylindrical shape, and forms a male screw portion 9 of a helical screw or a double thread on the outer periphery thereof,
At its upper end, an inwardly directed upper flange portion 10 is formed, and at its lower end, an outwardly directed lower flange portion 11 is formed. As shown in FIG. 4, a stepped disk-shaped plug body 6 is inserted into the port 7 from below.
Is inserted into the lower portion of the plug body 6, and the ring-shaped membrane 8 whose upper end is closed by the membrane portion 8a is pushed in and fitted, whereby the port 7, the plug body 6 and the membrane 8 are integrally formed. Is combined with At this time, the stepped upper end 6a of the plug body 6 is fitted into the upper flange 10 of the port 7, so that the upper end surface of the plug body 6 and the upper surface of the upper flange 10 are flush. An annular groove 12 is formed on the lower end surface of the plug body 6, and an annular convex portion 13 protruding from the upper end surface of the membrane 8 is fitted into the annular groove 12. A retaining rib 14 is formed on the outer periphery on the lower end side of the membrane 8, and the retaining rib 14 is fitted and fitted in a concave groove 15 provided on the inner periphery on the lower end side of the port 7 in a retaining shape.

The plug 5 thus formed is thus formed.
As shown in FIG. 3, the lower flange 11 of the port 7 and the lower end of the membrane 8 are overlapped on the upper end surface of the mouth 4 of the container body 1, and the overlapped portion is heat-welded or ultrasonically welded. It is integrally connected to the part 4.

As shown in FIG. 2, the double-ended needle 2 is an integrally molded product made of a thermoplastic resin such as hard polypropylene, and has an outer ring 16 and a pair of upper and lower members arranged on the center axis of the outer ring 16. Needles 17a and 17b communicating with each other
And a connecting plate portion 18 integrally connecting an intermediate portion of the upper and lower needles 17a and 17b in the vertical direction and an inner peripheral portion of the outer peripheral ring 16.
Consists of The communication hole 19 of the upper and lower needles 17a and 17b may be one hole, but preferably two holes. As shown in FIG. 5, a vial holding tube portion 22 for inserting and holding the mouth portion 21 of the vial 20 is integrally formed on the upper surface side of the connecting plate portion 18 so as to be open upward with the upper needle 17a as a center. A vial retaining ridge 23 is formed on the inner periphery of the vial holding cylinder 22. As shown in FIG. 2, an engagement groove 24 is formed on the inner periphery on the lower end side of the outer peripheral ring 16.

As shown in FIG. 2, the double-ended needle holding cylinder 3 is an integrally molded article formed of an inner and outer double cylinder structure with a thermoplastic resin such as soft polypropylene, and has an outer cylinder 25 and an outer cylinder 25. An inner cylinder 26 continuously formed in a shape bent into a U-shaped section and a U-shaped groove 27 formed between the inner and outer cylinders 25 and 26 are formed inside the lower end of the inner cylinder. On the inner periphery of the inner cylinder 26, a female screw portion 28 that is screwed with the male screw portion 9 on the mouth side of the container body 1 is formed. In this case, the male screw portion 9 and the female screw portion 28 may be a spiral screw or a double-threaded screw, but the double-threaded screw is preferable because the double-ended needle holding cylinder 3 can be quickly rotated and opened / closed. A flange 29 is formed so as to extend inward from a portion above the female screw portion 28 of the inner cylinder 26, and an annular sealing projection 30 protrudes downward on the inner periphery of the flange 29. In this case, as shown in FIG. 3, the double-ended needle holding cylinder 3 fixes the female screw portion 28 of the inner cylinder 26 to the container main body 1 until the flange 29 of the inner cylinder 26 contacts the upper surface of the upper flange 10 of the container main body 1. When the screw is tightened to the male screw portion 9 on the mouth side, the sealing projection 30 bites into the upper surface of the plug main body 6 and tightly seals it.

As shown in FIGS. 1 and 3, the double-ended needle 2
The lower end of the outer peripheral ring 16 is the inner and outer cylinder 2 of the double-ended needle holding cylinder 3.
The needle is held in the double-ended needle holding cylinder 3 by being vertically slidably fitted into the U-shaped groove 27 between the needles 6 and 25. At this time, in order to easily insert the lower end of the outer peripheral ring 16 into the U-shaped groove 27 and to easily slide up and down, a V-shaped cut 31 is formed in the upper end edge of the inner cylinder 26 in the circumferential direction as shown in FIG. At a predetermined interval, and the upper end edge is formed so as to be deformable in diameter. In this case, the cut 31 may be provided at the lower end edge of the outer peripheral ring 16 of the double-ended needle 2 instead of being provided at the upper end edge of the inner cylinder 26. However, in this case, the strength of the lower end portion of the outer peripheral ring 16 tends to decrease. Therefore, in order to secure the strength, it is preferable that the cut 31 is provided at the upper end edge of the inner cylinder 26.

When the double-ended needle 2 is slid up to the highest position in the double-ended needle holding cylinder 3 so that the tip of the lower needle 17b is located slightly above the plug 5 of the container body 1, as shown in FIG. As shown in FIG. 2 and FIG. 4, the inner cylinder 26
The upper engaging ridge 32 is provided on the outer periphery on the upper end side of the double-ended needle 2 so that the upper engaging ridge 32 is engaged with the engaging groove 24 on the lower end side of the double-ended needle 2. Further, as shown in FIGS. 2 and 3, a lower engaging ridge 33 is provided on the outer periphery on the lower end side of the inner cylinder 26.
When the double-ended needle 2 is slid downward to the lowest position until the lower needle 17b pierces the stopper 5 of the container body 1, the engagement groove 24 engages with the lower engagement ridge 33 as shown in FIG. The double-ended needle 2 is prevented from inadvertently sliding upward.

The upper end opening surface of the outer cylinder 25 of the double-ended needle holding cylinder 3 is sealed with a removable paper 34 as shown in FIG. The inner surface of the outer cylinder 25 is formed with an air vent vertical groove 35 for bleeding air from between the sliding surface of the outer ring 25 and the outer cylinder 25 when the double-ended needle 2 slides up and down (FIG. 2), and the air vent vertical groove 35 is not always necessary.

As described above, the solution is put into the container body 1 and
The mouth 4 is sealed with a plug 5, the double-ended needle 2 is attached to the mouth 4 of the container body 1 via the double-ended needle holding cylinder 3, and the upper end opening surface of the outer cylinder 25 of the double-ended needle holding cylinder 3 is re-fitted. After sealing with the peelable sterile paper 34, steam sterilization is performed. At the time of this steam sterilization, the sealing projection 30 provided annularly on the inner periphery of the flange portion 29 of the double-ended needle holding cylinder 3 is tightly sealed on the upper surface of the plug 5 of the container body 1. Cooling water does not enter the plug 5 from the gap between the male and female screw portions 28 and 9 between the double-ended needle holding cylinder 3 and the mouth of the container body 1. The solution container 1 subjected to the steam sterilization can be kept in a sterilized state by being externally wrapped with a barrier film in a sterile room.

Next, the procedure of using the steam-sterilized solution container having the above structure will be described with reference to FIGS. First, after removing the sterilized paper 34 from the outer tube 25 of the double-ended needle holding tube 3, as shown in FIG. 5, the mouth portion 21 of the vial 20 containing the medicine is inserted into the vial holding tube portion 22 while When the part 21 is applied to the tip of the upper needle 17a of the double-ended needle 2 and the vial 20 is further pressed down, the rubber stopper 36 in the mouth 21 of the vial 20 is pierced through the upper needle 17a.
At this time, since the double-ended needle 2 is engaged and held in the engagement groove 24 of the outer peripheral ring 16 by the upper engagement ridge 32 of the inner cylinder 26 of the double-ended needle holding cylinder 3, the lower needle 17b is not moved downward. The plug 5 of the container body 1 containing the solution is not pierced.

Next, when a strong depressing force is further applied to the vial 20, the double-ended needle 2 moves the engagement groove 24 into the upper engagement ridge 3
2, and slides downward along the U-shaped groove 27 so that the engagement groove 27 is engaged with the lower engagement ridge 3 as shown in FIG. 6.
Slide down until it engages 3. Then double-ended needle 2
The lower needle 17b penetrates the plug 5 of the container body 1 and the membrane portion 8a of the membrane 8, whereby a communication state between the vial 20 and the container body 1 is obtained. Under this communication state, the vial 20 and the container body 1 are alternately turned upside down to mix and dissolve the medicine in the vial 20 with the solution in the container body 1, and return the dissolved drug solution into the container body 1. .

Thereafter, the vial 20 is pulled out from the upper needle 17a as shown in FIG.
2, the double-ended needle holding cylinder 3 can be easily removed together with the double-ended needle 2 from the mouth 4 of the container body 1 by rotating the female screw portion 28 in the loosening direction with respect to the male screw portion 9. This removal is easy for women and girls and the needles 17a, 1
7b allows safe operation without injury. Thus, the vial 20, the double-ended needle 2 and the double-ended needle holding cylinder 3 are removed,
The container body 1 containing the dissolved drug solution is provided for infusion administration.

The used container body 1, double-ended needle 2, and double-ended needle holding cylinder 3 are discarded. At this time, since the double-ended needle 2 and the double-ended needle holding cylinder 3 are both formed of the same resin material such as polypropylene, it is not necessary to separate and separate the double-ended needle 2 for disposal and recycling. 3 can be easily and safely processed while being stored.

The plug 5 can be made of a thermoplastic elastomer instead of the rubber plug body 6. That is, a membrane 8 having the same shape as that of the membrane 8 is simultaneously formed on the lower portion inside the port 7 having the same shape as the port 7, and a thermoplastic elastomer, preferably JIS hardness, is formed through the central opening of the upper flange 10 of the port 7. The plug body 6 made of a thermoplastic elastomer is integrally molded with the port 7 by insert-molding a thermoplastic elastomer of A25 to 70 degrees. According to this, the plug 5 with more excellent sealing performance can be obtained. The spout 5 is heat-sealed or ultrasonic-welded with the lower flange 11 of the port 7 and the lower end of the membrane 8 superimposed on the upper end surface of the mouth 4 of the container body 1 and integrally joined to the mouth 4. This is the same as in the above embodiment.

FIG. 8 shows the sealing projection 30 of the double-ended needle holding cylinder 3.
This shows another sealing means different from the sealing means of the above-described embodiment in that the sealing means is brought into close contact with the upper surface of the plug 5. This sealing means is provided with an annular groove 38 on the upper end surface of the port 7,
An elastic body 39 such as a thermoplastic elastomer is embedded in the annular groove 38, while the internal thread portion 2 on the inner periphery of the inner cylinder 26 is provided.
An annular sealing projection 4 closely attached to the upper surface of the elastic body 39 is provided on the lower surface of the flange portion 29 formed to extend inward from a portion above the upper portion 8.
0 protrudes downward. In this case, if the plug main body 6 is formed of a thermoplastic elastomer as described above, and the elastic body 39 in the annular groove 38 is formed of a thermoplastic elastomer, the plug main body 6 made of the thermoplastic elastomer and the thermoplastic elastomer can be used. Since the elastic body 39 made of a plastic elastomer can be simultaneously molded integrally with the port 7, the production can be simplified and the molding cost can be reduced.

FIG. 9 shows still another embodiment of the above-mentioned sealing means. This sealing means is provided on the outer periphery of the mouth side of the container body 1 below the externally threaded portion 9 of the double-ended needle holding cylinder 3. U
A flange portion 41 for receiving and supporting the outer bottom portion 27a of the U-shaped groove 27 is formed so as to protrude, and an elastic seal material 42 is provided on the upper surface of the flange portion 41. The sealing projection 43 is projected downward. This sealing means can be used in combination with the sealing means shown in FIG. 4 or the sealing means shown in FIG. 8 to form a gap between the double-ended needle holding cylinder 3 and the male and female threaded portions 28, 9 between the mouth side of the container body 1 and the inside and outside. It can be sealed tightly and has excellent sealing performance. Therefore, prevention of leakage of the solution,
This is advantageous because the effect of preventing contamination after steam sterilization and the effect of preventing contamination of the plug 5 can be further enhanced.

A test was conducted to evaluate the tightness of the dissolution liquid container assembled as described above. In this test, 50 ml of a 2% solution of methylene blue was put into the double-ended needle holding tube 3, the upper opening surface of the double-ended needle holding tube 3 was welded and sealed with a barrier film, and steam sterilization was performed at 121 ° C for 20 to 30 minutes. Was tested for tightness. As a result, a good result that there was no liquid leakage was obtained.

[0029]

As described above, according to the present invention,
The double-ended needle can be slid smoothly and stably up and down within the U-shaped groove of the double-ended needle holding cylinder, and even women and women can easily and safely remove the double-ended needle and its holding cylinder from the container body. It can be easily separated and discarded. In addition, the recycling of the double-ended needle and its holding cylinder eliminates the need for individual separation and separation.

[Brief description of the drawings]

FIG. 1 is a vertical sectional front view of a solution container according to one embodiment of the present invention.

FIG. 2 is a longitudinal sectional front view showing the dissolving solution container of FIG. 1 in a disassembled state.

FIG. 3 is an enlarged vertical sectional view of a sliding portion of a double-ended needle of the lysing solution container of FIG. 1;

FIG. 4 is an enlarged vertical sectional view of a screw connection portion between a mouth portion of the solution container of FIG. 1 and a double-ended needle holding cylinder.

FIG. 5 is a longitudinal sectional front view of a main part showing a state immediately before communication between the container main body and the vial of the solution container of FIG. 1;

FIG. 6 is a vertical sectional front view showing a state in which a container main body and a vial of the solution container of FIG. 1 are in communication with each other.

FIG. 7 is a longitudinal sectional front view showing a state where a double-ended needle holding cylinder and a vial are removed from a container main body of the solution container of FIG. 1;

FIG. 8 is an enlarged longitudinal sectional view showing another embodiment corresponding to FIG. 4;

FIG. 9 is an enlarged vertical sectional view showing still another embodiment corresponding to FIG. 4;

FIG. 10 is a vertical sectional front view of a conventional solution container.

FIG. 11 is a vertical sectional front view of another conventional solution container.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Container main body 2 Double-ended needle 3 Double-ended needle holding cylinder 4 Mouth part 5 Mouth plug 9 Male thread part 16 Outer ring 17a Upper needle 17b Lower needle 25 Outer cylinder 26 Inner cylinder 27 U-shaped groove 28 Female thread

Claims (1)

[Claims] 1. A resin body in which a mouth is hermetically sealed with a plug made of an elastic material that can be pierced with a needle, and a needle vertically communicating with each other in the center of the inside of an outer peripheral ring. It has a double-ended needle, an outer cylinder, an inner cylinder continuously formed in a shape bent into a U-shaped section inside the lower end of the outer cylinder, and an upwardly open U-shaped groove formed between the inner and outer cylinders. A double-ended needle holding cylinder, wherein the double-ended needle holding cylinder has a female screw portion provided on the inner periphery of an inner cylinder thereof screwed into a male screw portion provided on the outer periphery on the mouth side, and The lower end of the outer ring is slidably fitted in the U-shaped groove up and down, and the lower needle slides the lower needle of the double-ended needle through the spigot. Is a solution container formed of the same resin material as the double-ended needle.