JP2002052064A - Cap and medicine container using the same - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a cap allowing a hollow needle to be inserted into/pulled out easily to achieve a safe condition of inserting/pulling the needle and capable of securely preventing the leakage of liquid when and after the hollow needle is inserted or from the scar of the punctured needle, and a medicine container using the cap. SOLUTION: The cap 10 comprises a nearly barrel-shaped outer frame body 11 made of plastics and a nearly cylindrical plug body 12 made of thermoplastic elastomer for sealing the inside of the outer frame body 11. The plug body 12 has at least one narrow hole 13 extending in the axial direction (x) of the cap, shut by a thin wall 14 at least at one position. The outer frame body 11 is molded by melting/injecting plastics to cover the outer rim 12c of the plug 12, and the pressure contact force of 100-1000 kg/cm2 is applied to the plug 12 in the direction orthogonally crossing the axial direction of the cap. The cap 10 is used as closely fixed, for example, to the mouth of a medicine container.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a cap used for a mouth portion of a medicine container and a mouth portion of a side injection tube of an infusion line, and a medicine container using such a cap.

[0002]

2. Description of the Related Art In general, a cap having a rubber stopper is provided at the mouth of a medicine container for accommodating an infusion or injection solution, or at the mouth of a side injection tube of an infusion line used for infusion or the like. By inserting the rubber stopper with a medical hollow needle, injection needle, or the like, an operation of collecting a medicine from a medicine container, or injecting and mixing another medicine into the medicine container or an infusion line is performed.

[0003] Conventionally, in order to facilitate insertion of a hollow needle or the like into the rubber stopper, and in order to enable insertion of a hollow needle having a dull tip, a notch (slit) is formed therein. ) Is proposed (JP-A-5-124664). However, the rubber stopper disclosed in the above publication has a possibility that (1) a liquid leak may occur because a gap is formed between the hollow needle and both wall surfaces of the slit,
(2) Since the portion through which the hollow needle is inserted is an extremely narrow slit, the resistance at the time of needle insertion is still large, and (3) the hollow needle inserted into the rubber stopper may be loose due to the gap. There was a problem that there is.

[0004] On the other hand, for the purpose of solving the problems of the above-mentioned slit rubber plug, especially the liquid leakage, there has been proposed a plug with a slit changed to a fine hole (registered utility model No. 301343). However, the plug according to the above registered utility model has a problem that a portion of the pore is distorted by piercing the hollow needle or the like, especially after once inserting and removing the hollow needle in the pore portion. In the case where a hollow needle or the like is pierced into a portion other than the pore, there is a possibility that liquid leakage may occur from a puncture mark of the pore.

[0005]

In the conventional cap, the outer frame is generally made of plastic, and is used by welding this outer frame to the mouth of a plastic drug container. Therefore, an attempt was made to produce a cap by integral molding, in which the plug of the cap was changed from a rubber plug to a thermoplastic elastomer, the outer frame was injection-molded, and then the thermoplastic elastomer was injected to form the plug. ing.

However, since the thermoplastic elastomer generally has a large amount of distortion, the shape recovery rate of the plug is low.
Further, the cap is manufactured by injecting a thermoplastic elastomer into a cylindrical outer frame formed in advance and welding a plug made of the thermoplastic elastomer to the inner peripheral surface of the outer frame. . For this reason, when the plug is cooled and contracted, a force is applied to stretch the plug toward the welded portion with the outer frame (that is, the outer peripheral surface side of the plug). Therefore, the gap between the plug and the hollow needle or the like when the hollow needle or the like is inserted or the gap portion due to the needle puncture does not have the effect of closing the gap, and conversely, from the gap portion. This causes a problem that liquid leakage occurs.

Accordingly, an object of the present invention is to make it easy to insert and remove the hollow needle, to prevent the hollow needle from shaking when inserted, and to reliably prevent liquid leakage during and after insertion of the hollow needle. Provided is a cap capable of preventing a liquid from leaking from a needle stick mark even when a hollow needle is newly inserted in the vicinity of a place where a hollow needle has been inserted and withdrawn, and a drug container using the cap. That is.

[0008]

Means for Solving the Problems and Effects of the Invention The present inventors have conducted intensive studies to solve the above-mentioned problems, and have found that a thermoplastic elastomer having pores extending in the axial direction of a cap has been obtained. If a cap is designed so that a pressure contact force is always applied to the plug body in a direction perpendicular to the axial direction while using the plug body, liquid leakage or needle sticking at the time of insertion of the hollow needle and after insertion can be achieved. With the idea that a cap that could prevent liquid leakage from the mark could be obtained, further studies were conducted.

As a result, a plug made of a thermoplastic elastomer, which has been molded in advance, is placed in a mold, and plastic for the outer frame is injected so as to surround the outer edge of the plug to form an outer frame. In addition, the sum of the pressing force applied to the plug body in a direction orthogonal to the axial direction of the cap, such as the injection pressure of the plastic into the mold or the contraction pressure generated by cooling the plastic, is within a predetermined range. Surprisingly found a new fact that it is possible to obtain a cap that solved the above-mentioned problems, and completed the present invention.

That is, the cap according to the present invention comprises a substantially cylindrical outer frame made of plastic, and a substantially cylindrical plug made of a thermoplastic elastomer for closing the inside of the outer frame. Wherein the plug body has therein at least one pore extending in the axial direction of the cap and interrupted by a thin wall in at least one place, and the outer frame body is It is molded by melting and injecting plastic so as to surround the outer edge of the plug, and 100 to 1000 in a direction perpendicular to the axial direction of the cap with respect to the plug.
It is characterized in that a pressing force of kg / cm ² is applied.

According to the cap of the present invention, (i)
Since at least one pore is provided in the inside of the plug, the needle stick resistance of the plug is small, so that the insertion and removal of the hollow needle is easy, and (ii) the plug has the shaft of the outer frame. Since a predetermined pressure contact force is applied in a direction perpendicular to the direction, it is possible to easily eliminate the strain generated in the pore portion at the time of insertion of a hollow needle or the like, or to prevent shaking at the time of insertion of the hollow needle, Further, (iii) the plug is subjected to the pressure contact force, so the restoring force of the plug is large, and the self-closing property of the needle puncture is particularly high after the removal of the needle. Liquid leakage can be reliably prevented, and even when a new hollow needle is inserted in the vicinity of the place where the hollow needle has already been inserted / extracted, liquid leakage from the needle stick mark can be sufficiently prevented. Can be.

In the cap of the present invention, the magnitude of the pressing force applied to the plug in a direction perpendicular to the axial direction of the outer frame body is determined by the magnitude of the needle stick resistance and the restoring force of the plug (particularly, the needle stick trace). 100-1000 kg / cm ² , preferably 40
It is set in the range of 0 to 800 kg / cm ² . The thickness of the thin film is preferably set to be 0.2 to 2 mm from the viewpoint of obtaining an excellent effect of preventing liquid leakage while reducing needle stick resistance. The cross section of the pore is preferably circular, and the diameter is 0.1 to 3 mm.
More preferably,

The drug container of the present invention is a drug container for storing a drip solution, an injection solution, and the like, wherein the cap according to the present invention is provided at the mouth thereof. According to the medicine container of the present invention, the insertion and removal of the hollow needle is easy, the swinging of the hollow needle in the inserted state is prevented, and the liquid leakage during and after the insertion of the hollow needle is reliably prevented. Therefore, it is suitably used in medical sites and the like.

[0014]

DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, a cap according to the present invention and a medicine container using the same will be described in detail. [Cap] FIG. 1 (a) is a plan view showing an embodiment of a cap according to the present invention, and FIG. 1 (b) is a sectional view taken along the line AA. FIG. 2 is an explanatory view showing a manufacturing process of the cap 10, and FIG. 3 is a partially cutaway front view showing an example of a use state of the cap 10.

4 to 6 are sectional views showing other embodiments of the cap according to the present invention. As shown in FIG. 1 (b), for example, the cap of the present invention has a substantially cylindrical outer frame 11 made of plastic and a substantially cylindrical stopper made of a thermoplastic elastomer for closing the inside of the outer frame 11. And a body 12. The plug 12 has at least one pore 13 extending along the axial direction x, and the pore 13 is blocked by the thin wall 14 at at least one position in the axial direction x. In the embodiment shown in FIG. 1, the thin wall 14 has the pores 1 on the bottom side 12 b of the plug 12.
3 is closed.

The outer frame 11 is formed by melting and injecting plastic so as to surround the outer edge 12c of the plug 12. As shown in FIG. 3, the cap bottom surface 10b side of the outer frame 11 is welded to the mouth 61 of the medicine container 60. On the cap top surface 10a side of the outer frame 11, a plug 12
Film 15 for preventing dirt from adhering to the surface
Can be provided. The cap 10 of the present invention is manufactured, for example, through the steps shown in FIGS. That is, first, a plug 12 ″ made of a thermoplastic elastomer having pores 13 ″ is prepared in advance, and the plug 12 ″ is placed in a mold (not shown) for molding an outer frame (see FIG. 2 (a)).

Next, plastic is melt-injected so as to surround the outer edge 12c of the plug 12 ', and the outer frame 1
1 'is formed (see FIG. 2 (b)). At this time, the plug 12 '
Is a direction (horizontal direction) orthogonal to the axial direction of the cap due to the injection pressure of the plastic forming the outer frame 11 ′.
Is pressed against. The pressure applied to the plug 12 ′ by the injection pressure of the plastic constituting the outer frame 11 ′ is usually 9
It is about 0 to 900 kg / cm ² .

Further, the outer frame 11 thus formed is cooled and solidified (see FIG. 2 (c)). Thus, the cap 10 of the present invention is obtained. When the outer frame 11 is cooled, a pressing force in the horizontal direction y is applied to the plug 12 with the contraction. The pressing force applied to the plug 12 by the contraction of the outer frame 11 is usually about 10 to 100 kg / cm ² . When the pressing force (the sum of the injection pressure of the plastic forming the outer frame 11 'and the contraction of the outer frame 11) applied to the plug 12 in the horizontal direction y falls below the above range, the plug is closed. The shape restoration rate of the body 12 cannot be improved, and the restoring force of the plug body (particularly, the self-closing property of the needle puncture) becomes insufficient, and liquid leakage of the cap at the time of insertion and after insertion of the hollow needle is prevented. It cannot be prevented. Conversely, if the pressing force exceeds the above range, the needle stick resistance becomes too large and is not suitable for practical use. The pressing force is preferably 400 to 800 kg / cm ² in the above range.

(Outer frame) The outer frame of the cap of the present invention may be, for example, polyethylene, polypropylene, or poly-4.
Polyolefins such as -methylpentene [for example, trade name "TPX" of Mitsui Chemicals, Inc.]; polycyclic such as ethylene-tetracyclododecene copolymer [for example, trade name "Apel" of Mitsui Chemicals, Inc.] Olefins: acrylonitrile-butadiene-styrene copolymer (ABS); polyesters such as polyethylene naphthalate (PEN), polyethylene terephthalate (PET), and polyarylate; and benzene polymers such as polyphenylene sulfide (PPS) as medical tools. Various accepted plastics can be used.

(Plug) As the plug in the cap of the present invention, various thermoplastic elastomers which are conventionally used as a plug for a medicine container and which are acceptable as a medical device can be used. The characteristics of the plug are not particularly limited, and are generally not so strong or hard that it is difficult to penetrate the hollow needle, and are not easily deformed or damaged during normal storage. What is necessary is just to have the intensity | strength of. Although not limited to this, the hardness of the plug is JIS A hardness [JIS K
Spring hardness Hs measured by the method described in 6301
(JIS A)] and preferably from 20 to 70.
More preferably, it is 0 to 50. Further, the compression set of the plug is a value measured by a method described in JIS K 6301 [compression set CS (%), heat treatment temperature, so as not to be damaged even if the hollow needle is repeatedly inserted and removed. [Time: 70 ° C. × 22 hours] is preferably 50 or less.

Examples of the thermoplastic elastomer that can be used in the present invention include styrene-ethylene / butylene-styrene block copolymer (SEBS), styrene-butadiene-styrene block copolymer (SBS), and styrene-isoprene-styrene block. Copolymer (SIS),
Modified SEBS such as maleic acid modification, styrene-ethylene / propylene-styrene block copolymer (SEP
S), styrene-based elastomers such as styrene-ethylene / butylene block copolymer (SEB) and styrene-ethylene / propylene block copolymer (SEP); olefin-based elastomers such as ethylene-propylene block copolymer; polyurethane-based elastomers And the like.

Further, (a) a polymer block A mainly composed of at least two vinyl aromatic compounds and at least one conjugated diene compound described in JP-A-7-110084. A hydrogenated block copolymer having a number average molecular weight of 50,000 to 250,000 obtained by hydrogenating a block copolymer composed of polymer block B and (b) a binding unit composed of a specific phenylene oxide, and a reduced viscosity (0.5 g / dL chloroform solution,
30 ° C.) 0.15 to 0.70 of a homopolymer and / or a copolymer, a polyphenylene ether resin;
(c) a softener for aromatic rubber, and (d) a polyolefin hydrocarbon resin, a thermoplastic elastomer material comprising
It can be suitably used as a plug in the cap of the present invention.

(Pores) The pores provided in the stopper of the cap of the present invention are not particularly limited. However, from the viewpoint of obtaining an excellent liquid leakage prevention effect while reducing the needle stick resistance, the inner diameter is made smaller. It is preferable to set according to the outer diameter of a general hollow needle. That is, the inner diameter of the pore is usually 0.1 mm.
It is preferably set to 1 to 3 mm, more preferably 1 to 2 mm.

The cross-sectional shape of the pore is not particularly limited. However, from the viewpoint of obtaining an excellent effect of preventing liquid leakage while reducing the needle puncture resistance, it is preferable to make the hole circular according to the external shape of a general hollow needle. Is preferred. The vertical cross-sectional shape is not particularly limited, either. For example, as shown in FIG. 1B, a design is made such that the thin wall 14 is narrow and the plug 12 is wide on the top surface 12a. Can be. In this case, the moldability of the plug body 12, more specifically, the workability at the time of detaching the plug body from the mold for providing the pores becomes good. Further, when the opening of the fine hole 13 is on the side of the cap top surface 10a as in the embodiment shown in FIG. 1B, there is an advantage that the visibility of the fine hole 13 when the hollow needle is inserted is improved. There is also.

(Thin Wall) As described above, the pores provided in the plug of the cap of the present invention are characterized in that they are blocked by at least one thin wall. Such a thin wall may be provided, for example, at the end of the bottom surface side 12b of the plugs 12, 22 as shown in FIG. 1 (b) and FIG.
1 and 24 in FIG. ), FIG.
And the top side 12a of the plugs 32, 42 as shown in FIG.
(Thin walls are indicated by reference numeral 14 in FIG. 5 and reference numeral 24 in FIG. 6).

When the thin wall is provided at the end on the bottom side 12b of the plugs 12 and 22 (FIGS. 1 and 4), the effect of preventing liquid leakage can be remarkably improved. on the other hand,
When the thin wall is provided at the end of the top surface side 12a of the plugs 32 and 42 (FIGS. 5 and 6), the effect of further preventing the liquid leakage is obtained, and the plug body Surface side 1
The advantage that wiping of 2a becomes easy is obtained. The thickness of the thin walls 14, 24 is not particularly limited,
It is preferable to set the thickness to 0.2 to 2 mm from the viewpoint of obtaining an excellent liquid leakage prevention effect while reducing the needle stick resistance. By setting the thickness of the thin wall in the above range, it is possible to balance the effect of preventing liquid leakage and the resistance to needle stick.

As shown in FIGS. 4 and 6, for example, the thin wall may be a projection 25 projecting toward the bottom surface 12b or the top surface 12a at the ends of the plugs 22, 42, respectively. The radius is preferably set to 0.5 to 5 mm. By making the thin wall into a projecting shape and setting the radius of curvature in the above range, the effect of preventing liquid leakage when the hollow needle is pulled out can be further enhanced. [Drug Container] The drug container of the present invention is, for example, as shown in FIG.

The shape of the container body constituting the drug container 60 is not particularly limited, and various shapes of drug containers can be used as long as the cap 10 of the present invention can be brought into close contact with the mouth 61 thereof. Can be used.
Specific examples include an infusion bag and an infusion bottle. Further, the material of the container body constituting the drug container 60 is not particularly limited. However, in order for the cap 10 according to the present invention to be in close contact by welding, a drug container made of plastic, especially a thermoplastic plastic, is used. It is preferable to use Examples of the plastic include those similar to those exemplified as the plastic for the outer frame.

The cap of the present invention and the container body of the medicine container can be fixed to each other by, for example, heat welding or high frequency welding.

[0030]

Next, the present invention will be described with reference to examples and comparative examples. [Manufacture of cap] In the following Examples and Comparative Examples, 100 parts by weight of styrene-ethylene-butylene-styrene block copolymer (SEBS) and poly (2,6-dimethyl-1,4- An elastomer composition comprising 50 parts by weight of phenylene) ether resin, 20 parts by weight of polypropylene, and 150 parts by weight of process oil (trade name "Diana Process Oil PW-380" manufactured by Idemitsu Kosan Co., Ltd.) was used. In addition, polyethylene was used for the material of the outer frame.

Example 1 Using the above elastomer composition, a plug 12 '' having one pore 13 was prepared as shown in FIG. 2 (a). The pore 13 ″ was blocked by a thin wall at the end on the bottom surface 12b side of the plug 12 ″. Next, the plug 12 'was placed in a mold for injection molding, polyethylene was injected, and the outer frame 11' was molded so as to surround the outer edge 12c of the plug (FIG. 2 (b)). )). Further, the outer frame 11 'is removed from the mold and cooled (see FIG. 2 (c)).
The cap 10 shown in FIG. 1 was obtained.

The plug 12 of the obtained cap 10 has a resin injection pressure of 550 kg / c during the injection molding of the outer frame 11.
m ² and a pressure of 50 kg / cm ² calculated based on the size after the outer frame body 11 contracted by cooling.
600 kg in the horizontal direction y perpendicular to the axial direction x of 0
/ Cm ² was found to be pressed. In addition, the diameter d of the plug body 12 after the pressure welding by the outer frame body 11
Is 20 mm, the thickness t is 5.0 mm, the diameter of the pore 13 is 1.5 mm at the end of the top surface side 12a, and the plug 1
It was 1 mm inside 2 '. The thickness of the thin wall 14 was 0.5 mm.

COMPARATIVE EXAMPLE 1 As shown in FIG. 7, an outer frame 81 having one pore 83 was produced by injection molding using the above polyethylene. Next, the plug 82 shown in FIG. 7 was produced by injection molding using the above elastomer composition. The plug 82 is
The diameter d is 20 mm, the thickness t is 5.0 mm, and one pore 83 is formed inside. In addition, pore 8
3 has a thickness of 0.3 mm at the end on the bottom side 82b of the plug 82.
It had a thin wall 84 of 5 mm, and the diameter of the pore 83 was 1.5 mm at the end on the top side 82 a and 1 mm inside the plug 82. The thickness of the thin wall 14 is 0.5
mm.

[Preparation of Infusion Container and Performance Test] (Preparation of Infusion Container) The cap obtained in the above-mentioned Example 1 and Comparative Example 1 was placed on the mouth of a polyethylene infusion container (drug container) filled with 100 mL of distilled water. Respectively. The following performance test was performed using the infusion container thus obtained. (Performance Test I) A plastic hollow needle having a diameter of 5 mm was pierced into the pores of the cap 10 and extracted, and then a 16-gauge metal needle was pierced at the same location. Next, the infusion container was hung with the cap portion down, air was fed into the infusion container from a metal needle and pressurized, and the presence or absence of liquid leakage was observed.

As a result, no liquid leakage was observed even when a pressure of 0.07 MPa was applied to the infusion container using the cap of Example 1. It should be noted that if pressure is applied to the infusion container exceeding the above value, the metal needle may fall off, and thus evaluation was not performed at a pressure of 0.07 MPa or more. On the other hand, in the case of the infusion container using the cap of Comparative Example 1, the liquid leaked while applying a pressure of 0.01 MPa.

(Performance Test II) A plastic needle having a diameter of 5 mm was pierced into the pores of the cap 10 and extracted, and then a 16-gauge metal needle was pierced about 3 mm away from the pores. Next, the infusion container was hung with the cap portion down, air was fed into the infusion container from a metal needle and pressurized, and the presence or absence of liquid leakage was observed. As a result, even when a pressure of 0.07 MPa was applied to the infusion container using the cap of Example 1, no liquid leakage was observed. 0.0
The reason why the test was not performed at a pressure of 7 MPa or more is the same as “Performance Test I”.

On the other hand, in the case of the infusion container using the cap of Comparative Example 1, the liquid leaked when a pressure of 0.01 MPa was applied. (Evaluation of Performance Test) In each of the infusion containers of Example 1 and Comparative Example 1, insertion and removal of the hollow needle was easy because the pores were provided inside the stopper. On the other hand, as for the insertion state of the hollow needle, in Example 1, the fixed state of the hollow needle was good, and no shaking occurred. However, in Comparative Example 1, the hollow needle was unstable, and shaking was observed relatively remarkably. .

Further, as is clear from the results of the performance tests I and II, according to the infusion container of Example 1, liquid leakage at the time of insertion of the hollow needle and after insertion is reliably prevented, and already Even when a new hollow needle was inserted in the vicinity of the place where the hollow needle was inserted / extracted, it was possible to prevent liquid leakage from a needle stick mark. In contrast, in the infusion container of Comparative Example 1, the effect of preventing liquid leakage was insufficient.

[Brief description of the drawings]

FIG. 1A is a plan view showing an embodiment of a cap according to the present invention, and FIG. 1B is a sectional view taken along the line AA of FIG.

FIG. 2 is an explanatory view showing a manufacturing process of the cap 10 shown in FIG.

FIG. 3 is a partially cutaway front view showing an example of a use state of the cap 10 shown in FIG. 1;

FIG. 4 is a cross-sectional view showing another embodiment of the cap according to the present invention.

FIG. 5 is a sectional view showing still another embodiment of the cap according to the present invention.

FIG. 6 is a sectional view showing still another embodiment of the cap according to the present invention.

FIG. 7 is a sectional view showing a cap of Comparative Example 1.

[Explanation of symbols]

 10, 20, 30, 40 Cap 11 Outer frame 12, 22, 32, 42 Plug 12c Outer rim 13 Pores 14, 24 Thin wall 60 Drug container 61 Mouth x-axis direction Direction orthogonal to y-axis direction (horizontal direction) )

 ────────────────────────────────────────────────── ─── Continued on the front page (72) Inventor Hideki Kobatake 208-16 Shimomotojo, Myojin, Seto-cho, Naruto-shi, Tokushima F-term (reference) 3E084 AA06 AA24 AB05 BA02 CA01 CB02 CC03 FA09 FD13 HD01 KB02 LB02 LB07 LD30 4C066 BB01 BB10 CC01 EE11 FF05 LL30 PP04

Claims (6)

[Claims] 1. A cap comprising: a substantially cylindrical outer frame made of plastic; and a substantially cylindrical plug made of a thermoplastic elastomer for closing the inside of the outer frame. Has at least one pore therein extending in the axial direction of the cap and interrupted by a thin wall in at least one place, and the outer frame surrounds an outer edge of the plug. So that the plastic is melt-injected and molded, and 100 to 100 in the direction perpendicular to the axial direction of the cap with respect to the plug.
A cap to which a pressing force of 0 kg / cm ² is applied. 2. The pressure contact force is 400 to 800 kg / cm ^2.
The cap according to claim 1, which is: 3. The cap according to claim 1, wherein said thin wall has a thickness of 0.2 to 2 mm. 4. A cross section of the fine pore is circular.
The cap according to any one of the above. 5. The cap according to claim 4, wherein the diameter of the pore is 0.1 to 3 mm. 6. A medicine container provided with a cap according to any one of claims 1 to 5 at its mouth.