JP2000210384A - Medical stopper - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medical stopper capable of reducing the resistance of stinging to the stopper and of preventing the drop of a needle even in the case of long-time use. SOLUTION: This stopper is composed of a rubber core body 11.. having a small hole 12 for needle guide in non-through state and a wrapping body 13 pressing at least the side wall of the core body 11 and the small hole 12 for needle guide is compressed in a closing direction by the wrapping body 13. Concerning such a medical stopper, the material of rigidity greater than that of the core body 11 is used for the wrapping boy 13 and the stopper can be provided by the injection molding of the wrapping body 13 in the sate of integrating the previously molded core body 11.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical plug used for a cap of an infusion container or the like.

[0002]

2. Description of the Related Art A conventional rubber stopper is provided with a dome-shaped inlet or a ring-shaped protrusion at a co-injection point of a medicine as a puncture point of a plastic or metal needle on the upper surface of the rubber stopper. Things exist. On the lower surface of the rubber stopper, there is a rubber stopper having a dome-shaped recess at a location symmetrical to the puncture portion, or a flat rubber stopper. When a plastic needle or a metal needle is punctured into such a rubber stopper, there is a problem that puncture resistance is large, and when a large number of puncturing operations are required, a burden is imposed on an operator.

[0003] Further, it has been pointed out as a problem that a needle may be rolled up into a chemical solution by a part of a rubber stopper or a part of a plastic septum due to a high piercing resistance, thereby causing coring.

[0004] Further, apart from the problem of puncture resistance, due to the risk of infection with hepatitis or AIDS, a needle for puncturing a rubber stopper is mistakenly punctured, or the tip of the needle is discarded after puncturing. Therefore, there has been a demand for a rubber stopper that can use a communication tool having a sharp tip.

In order to solve these problems, Japanese Patent Publication No. Hei 5-3
No. 2071 discloses a rubber stopper in which a slit is previously formed in the rubber stopper. As for the type of rubber stopper of Japanese Patent Publication No. 5-32071, a type without general lamination is considered. However, when a film is laminated on a liquid contact surface of the rubber stopper, a type without lamination is used. Since the elasticity of the surface of the rubber stopper is lower than that of the rubber stopper, in the case of a straight type slit, rubber cracks easily run in two directions from the puncture point, and there is a risk of liquid leakage.

In order to eliminate such a risk, Japanese Utility Model Registration No. 3004402 discloses a medical rubber stopper provided with slits extending in three directions and forming a thin film portion on a surface in contact with a chemical solution or the like.

[0007]

However, the above-mentioned 2)
In the rubber stopper disclosed in the above, since the slit is provided in advance, the puncture resistance of the needle may be suppressed small, but conversely, there is a high risk of the needle coming off during use. In other words, the elasticity of the rubber stopper is reduced by the slit provided in advance, and when a needle pierced through the slit through the rubber stopper, particularly a plastic needle, is used, the needle may drop out when used for a long time. It was with. In order to prevent this, it is solved by manufacturing the plug with a material having relatively high elasticity. However, if this means is adopted, resistance when piercing the needle with the plug increases, and the worker has a problem. This leads to an increased burden.

In view of the above, it is an object of the present invention to provide a medical plug which can reduce puncture resistance to the plug and prevent needle removal even when used for a long time. I do.

[0009]

Means for Solving the Problems As a result of intensive studies conducted by the present inventor to solve such a problem, the present invention has a structure of a medical plug which can improve the needle removal resistance of a rubber plug provided with a slit. Was completed.

[0010] The present invention comprises a rubber core having a needle guiding small hole in an unpenetrated state, and a package for pressing at least a side wall of the core, wherein the needle guiding small hole is closed. The gist of the present invention is a medical plug compressed by the package.

According to the present invention, a needle guide hole is provided in advance in the core, which is a needle piercing point, so that the puncture resistance of the needle can be reduced, and the needle is provided around the core. Since the envelope presses the core from the surroundings, and the needle guiding small holes are compressed by the envelope in the closing direction, it is possible to improve the needle removal resistance.

A medical plug having this structure can be easily manufactured by injection-molding a package with a preformed core incorporated therein. At this time, since a high-pressure material in a molten state under high pressure is injected, the core body disposed in the parity contracts by receiving pressure from its side wall toward the center, and a force acts in the center direction. It will be arranged in a plug body in the state where it was set. As a result, the needle guide hole is compressed by the package in the closing direction. The force acting in the center direction generates a force for the core body to hold the needle when the needle is pierced, so that the resistance of the needle coming off can be improved.

In this case, it is necessary that the package is made of a material having higher rigidity than the core. When the package is molded from a material with low rigidity, the force of the core to return to its original size is greater than the force of the package to press down on the core. This is because it is no longer pressed.

In the present invention, the needle guide small hole provided in advance in the core body may be simply a slit-shaped slit having a notch. In view of shrinkage, it is preferable to secure a certain size of the hole diameter. In particular,
It is preferable that the pore diameter gradually decreases from the upper side to the lower side.

Further, in order to prevent the core from cracking,
At this time, it is preferable that the shape (cross section or surface shape) of the needle guiding small hole is widened in three directions. Although not limited in the present invention, it is also preferable that the shape of the small hole for guiding the needle be a cross shape or a star shape (cross section or surface shape).

In the present invention, since the package is injection-molded in a state where the core is incorporated, it is preferable that the core and the package are completely adhered at the joint surface. To achieve this, specifically, a resin containing a thermoplastic elastomer is excellent in the production process in that it does not require a vulcanization step like rubber and can be molded by a simple method such as injection molding. It is preferred to use Here, what is meant by a resin containing a thermoplastic elastomer in the present specification is a resin containing only a thermoplastic elastomer or a mixture of a thermoplastic elastomer and rubber. The resin containing a thermoplastic elastomer has a lower elasticity than rubber, and when used as a medical stopper, needle removal has conventionally been a problem, but when used as a core of the present invention, In this case, the core body is tightened from the periphery, and the holding ability of the needle can be improved, so that it can be suitably used.

The medical plug of the present invention can be suitably used as a cap for an infusion container or a blood circuit, and is also applicable to a system for mixing and using a drug called half-kid or full-kid, for example. It can be suitably used. It can also be used for a transfusion container for co-infusion of two or more liquids. In this case, a co-infusion port is provided separately from the above-mentioned core having a small needle guide hole in order to pierce a needle at a plurality of locations. A core body having a plurality of small needle guiding holes according to its function is combined, such as providing at least one core body having a small needle guiding hole having the same structure, It is also possible to provide a medical stopper that is integrally arranged with the body. For example, a core of a co-injection rubber-like body having an unpenetrated needle guide small hole is combined and arranged in the same package, and the co-infusion rubber-like core is also used for the needle guide. The stoma is a medical plug that is compressed by the envelope in the closing direction.

[0018]

FIG. 1 is a schematic view showing the structure of a medical plug according to the present invention. In FIG. 1, reference numeral 1 denotes a medical stopper according to the present invention, 11 denotes a core, 12 denotes a small needle guiding hole, and 13 denotes a package. In FIG. 1, the core body 11 receives pressure from the periphery, and a force for tightening the core body from the periphery to the center acts, and the needle guide small hole 12 is compressed in the closing direction by the package 13. The medical plug 1 having this structure is manufactured by injection molding with the core 11 incorporated in the molding of the package 13.

The shape of the core body 11 is not particularly limited, but is preferably a columnar shape or a frustum shape. In the present invention, since the core body can apply a pressing force to its surroundings by the package body, for example, if the core body having a cylindrical shape is taken as an example, the bottom area can be reduced and the needle can be penetrated. In the range, the ratio of the side area to the bottom area is preferably large, that is, it is elongated. Further, ribs and grooves can be provided on the side walls and the like in order to further strengthen the bonding with the package.

The small hole 1 for guiding the needle which is not penetrated
2 are provided. This is because if the needle guide small hole 12 penetrates, the solution inside the container comes into contact with the outside air and also causes a liquid leak during storage or the like.

FIG. 2 is a view showing a cross section of the core 11. The thickness D between the lower surface of the core body 11 and the small needle guiding hole 12 is not particularly limited, but is preferably about 0.1 mm to 2 mm. When the thickness is 0.1 mm or less, it is the minimum that can be formed by injection molding, and it is difficult to mold in a thinner state. If the thickness exceeds 2 mm, the resistance increases when the needle is pierced, which is not convenient for the operation. It is preferable that the diameter of the small needle guide hole 12 is gradually reduced from the upper part to the lower part because the needle removal resistance is easily maintained strongly.

Needle guide small hole 1 provided in core 11
2 extends in three directions as shown in FIG. 1, and may be a linear slit (a), an elliptical (b), or a cross-shaped slit (c) as shown in FIG. Although there is no particular problem, in view of shrinkage of the core body during production, holding force of the needle and ease of production, and prevention of breakage during use, a slit extending in three directions or a cross-shaped slit is preferable.

The core 11 is preferably made of a resin containing a thermoplastic elastomer as a material. Since the medical plug of the present invention forms the package around the core, the bonding strength between the core and the package and the ease of molding are taken into consideration. With a resin containing a thermoplastic elastomer,
It means a thermoplastic elastomer alone or a mixture of a thermoplastic elastomer and rubber. The thermoplastic elastomer used is not particularly limited in its type. For example, hydrogenated polystyrene-based elastomers, polyvinyl chloride-based elastomers, polyolefin-based elastomers, polyurethane-based elastomers, polyester-based elastomers, and polyamide-based elastomers can be exemplified. In particular, Alon Kasei's thermoplastic elastomer: trade name "AR-860C", Aron Kasei's thermoplastic elastomer: trade name "AR-697C", Mitsubishi Chemical's thermoplastic elastomer: trade name "Lavalon T-331"
C "can be used optimally. The rubber to be mixed with these thermoplastic elastomers is not particularly limited, but silicon rubber can be particularly preferably used.

A plurality of cores may be provided and used as a cap of an infusion container for infusion mixing. FIG. 4 is a diagram showing the structure of the medical plug when a plurality of cores are provided,
A plan view and an AA ′ cross-sectional view of such a medical plug are shown. Even in the case shown in FIG. 4, the plurality of cores 11 are each compressed from the surroundings by the package 13, and are subjected to the pressing force by the package 13. When a plurality of cores are provided, it is preferable to provide a connecting portion 111 for connecting the cores and the cores in order to facilitate the molding, and to perform the molding simultaneously at one time. In this case, since the portion of the core 11 that is connected by the connecting portion 111 is not subjected to the pressing force by the package 13, the needle guide for the needle is taken into consideration in consideration of the contractility of the core when the package 13 is formed. It is preferable that the small holes 12 are provided in the core body 11 except for the thickness of the connecting portion.

Since the package 13 of the medical stopper according to the present invention generates a pressing force for tightening the core 11 from the surroundings as described above, it is injected with the preformed core incorporated therein. Preferably, it is molded and manufactured. By adopting this step, the pressure at the time of injection acts on the core, and a force for tightening the core from the surroundings is generated. Therefore, it is easy to adjust the pressing force acting on the core by adjusting the injection pressure. However, it is necessary that the material forming the package has higher rigidity than the material forming the core. Specifically, general-purpose plastics such as polyethylene, polypropylene, and polystyrene are preferably used.

Even when the injection molding method is not used, a pressing force can be applied to the core body from the periphery by using another method. For example, it is also possible to apply a pressing force to the core by pressing the molded plug from the periphery. However, in these cases, in addition to the above-mentioned injection molding method, a separate step is required, and it is often difficult to adjust the pressing force for tightening the core.

Although the package covers at least the side wall of the core, the package may, for example, further cover the bottom surface. In this case, the wrapper serves as a thin film portion provided on the lower surface of the core body, and can prevent foreign substances generated from the core body of the rubber-like body from being mixed into the infusion solution when the needle is punctured. it can.

In the case where the envelope serves as the thin film portion of the stopper as described above, the envelope is formed of a relatively flexible material in order to reduce the penetration resistance of the needle. It is necessary. Specifically, polyethylene, polypropylene, polystyrene and the like can be suitably used, and particularly, low-density polyethylene can be optimally used.

The medical plug of the present invention can be provided with a lock mechanism around the package. By providing the lock mechanism, the effect of needle removal during use can be further improved. Further, the lock mechanism is not particularly limited, but since it is possible to improve the easiness of the needle insertion operation, a mechanism such as a lure lock type that can change the rotational force into the force of the plug intrusion is used. Preferably, there is.

FIG. 5 is a schematic view showing a medical cap provided with a luer lock type locking mechanism. In this case, it is preferable that the height of the core body 11a on the side where the needle is punctured is larger than the height of the core body 11b forming the co-injection port.

As an example of the luer lock type locking mechanism 2, there is a mechanism as shown in FIG. FIG. 6 is an enlarged perspective view of the vicinity of the core 11a in FIG. As shown in FIG. 6, a package 13a that forms the periphery of the core 11a includes:
A pair of protrusions 21 are provided at opposite positions on the upper peripheral wall of the package 13a as the luer lock type locking mechanism 2.

FIG. 7 is an enlarged view of the distal end of a luer lock type needle used suitably for the medical stopper having the lock mechanism of FIG. In FIG. 7, 3 is a needle part, 31 is a needle, 32
Is a hakama body, and 22 and 22 are guide grooves which are formed in the inner wall of the hakama body 32 and which are spirally formed with each other, and into which the protrusions 21 and 21 are fitted. That is, the protrusions 22, 22 are
Hakama body 32 is screwed around the package body 13a and is connected to the casing body 13a. In this case, the pitch P of the guide groove 22 is set between the lower surface of the core 11 and the small hole 12 for needle guide.
Is preferably larger than the thickness D. The needle 31 is provided at the center of a cylindrical hakama body 32.

When the needle of FIG. 7 and the medical stopper of FIG. 6 are used in combination, when the needle part 3 is put on the medical stopper, the needle 3
The tip of 1 is inserted into the small needle guide hole 12 provided in the core body 11. Guide grooves 22 provided in the needle portion 3
Are stuck in the protrusions 21 provided on the medical stopper. At this time, the needle 31 has not penetrated the stopper. Then, by twisting the needle portion 3, the needle portion 3 is screwed down along the guide grooves 22, 22, using the protrusions 21, 21 as a guide, and accordingly, the needle provided in the needle portion 3 is Move down. Therefore, the needle 31 breaks through the needle guide small hole 12 provided in the core body 11, and as a result, the needle 31
Penetrates the plug.

By providing the luer lock type locking mechanism in this manner, the force for twisting the needle portion acts as a force for pushing the needle, so that the needle can be pierced by a simple operation as compared with a case without such a mechanism. It becomes possible. Further, by providing such a lock mechanism, it is more effective to prevent the needle from coming off during use.

As another form of the lock mechanism, a mechanism that simply locks the protruding portions may be used, but the piercing resistance cannot be reduced. Further, a screw type may be used, but the molding is complicated and the manufacturing is liable to be restricted.

The medical plug according to the present invention is manufactured, for example, as follows. FIG. 8 is a flowchart showing a manufacturing process of the medical plug according to the present invention.

In the manufacturing process of the medical cap of the present invention, first, (a) a core is formed. In FIG. 8, a method by injection molding using a thermoplastic elastomer as the material of the core is employed. To this end, the upper mold 51 for the core and the lower mold 52 for the core are joined and molded by injecting a thermoplastic elastomer into a cavity formed by these molds. (B) The core thus manufactured is taken out and placed in a package mold. In FIG. 8, since a plurality of cores are provided, a connecting tool 111 for connecting these cores is provided.
(C) Upper mold 61 for the package and lower mold 62 for the package in which the core is arranged
And a thermoplastic resin such as polyethylene is injection-molded in a cavity formed by these molds. By adjusting the injection pressure when molding the envelope,
The pressing force applied to the core can be adjusted. These injection pressures may be appropriately determined depending on the type of the thermoplastic resin used, the rigidity of the material constituting the core, the needle used, and the like. (D) Take out the medical plug thus obtained and complete it.

The medical stopper of the present invention can be used for caps of various kinds of infusion containers and blood circuit containers. The cap using the medical stopper of the present invention is preferably provided with a base for joining with an infusion container and a lid for hygiene, and then joined with the infusion container by means such as heat sealing. .

[0039]

The medical plug according to the present invention comprises a rubber core having an unpenetrated needle guide hole and a package for pressing at least the side wall of the core. Since the guide hole is a medical stopper compressed by the package in the closing direction, the package is tightened from the surroundings, so that the needle penetration resistance is kept low while keeping the needle penetration resistance small. Can be improved.

Also, the above-mentioned medical core is easily manufactured by using a package having a higher rigidity than the core and by injection-molding the package with the core molded in advance during the production incorporated. can do.

Further, by providing a luer lock type locking mechanism, the penetration resistance of the needle can be further reduced, and the resistance of the needle coming off can be improved.

[Brief description of the drawings]

FIG. 1 is a schematic perspective view showing the structure of a medical plug according to one embodiment of the present invention.

FIG. 2 is a schematic sectional view of a concentric body.

FIG. 3 is a schematic plan view of a core body showing examples of some other shapes of the needle guide small hole.

FIG. 4 is a schematic plan view showing the structure of the medical plug when a plurality of cores are provided, and a cross-sectional view taken along the line AA ′ thereof.

FIG. 5 is a schematic sectional view showing a medical cap when a luer lock type locking mechanism is applied.

FIG. 6 is an enlarged perspective view of a main part of FIG. 5;

7 is a schematic enlarged perspective view of a distal end portion of a luer lock type needle portion suitably used for the medical stopper having the lock mechanism of FIG. 6;

FIG. 8 is a flowchart showing a manufacturing process of the medical plug according to the present invention.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Medical plug 11 Core 12 Small needle guide hole 13 Envelope

Claims (8)

[Claims] 1. A rubber-like body having an unpenetrated needle guide small hole, and a package for pressing at least a side wall of the core, wherein the needle guide small hole is closed in a closing direction. Medical plug compressed by a wrapper. 2. The medical plug according to claim 1, wherein the package has higher rigidity than the core, and the package is injection-molded with the preformed core incorporated therein. 3. The needle guide small hole has a shape expanding in three directions,
3. The medical plug according to claim 1, wherein the plug is formed of a cross-shaped or star-shaped slit. 4. The medical plug according to claim 1, wherein the core is made of a resin containing a thermoplastic elastomer. 5. The medical plug according to claim 1, wherein a plurality of cores are provided. 6. The medical plug according to claim 1, wherein the package is provided with a luer lock type locking mechanism. 7. A thin film portion is provided on a lower surface of a core body, and the thin film portion is configured as a part of a package.
The medical stopper according to any one of the above. 8. A co-injection rubber-like core having an unpenetrated needle guiding small hole is combined and arranged in the same package, and the co-injection rubber-like core is also provided in the co-infusion rubber-like core. The medical stopper according to any one of claims 1 to 7, wherein the needle guide hole is compressed by the envelope in the closing direction.