JP2013000461A - Elastic stopper and medical cap including the same - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an elastic stopper allowing easy needle puncture by reducing puncture resistance in time of the puncture by a puncture needle such as a plastic needle even if the elastic stopper contains a thermoplastic elastomer resin component, and to provide a medical cap including the same.SOLUTION: This elastic stopper 11 for closing an opening of a container includes at least one recessed part 13 for performing the needle puncture of the puncture needle in an optional position of a needle puncture face 14 of the elastic stopper 11, the bottom face of the recessed part 13 is flat, an opening edge part and the bottom face of the recessed part 13 are larger than a maximum diameter of the puncture needle, and the opening edge part of the recessed part 13 has an area not contacting with the puncture needle when performing the needle puncture of the puncture needle into the recessed part 13.

Description

  The present invention relates to an elastic stopper used for closing a container such as an infusion container, a blood collection tube, and a vial, and a medical cap provided with the elastic stopper. In particular, the present invention relates to an elastic stopper that can easily pierce a puncture needle such as a medical plastic needle and a medical cap including the same.

  Medical containers used in the medical field, such as drug bottles and infusion bottles for infusion, are provided with a medical cap for closing the opening. Further, as the medical cap, a rubber stopper or an elastic stopper (for example, rubber or elastomer resin) provided on the inner side of the support is used so that the chemical liquid can be taken out with a plastic needle. Yes. In addition, such a medical cap is required to have a hermetic seal in order to prevent leakage of chemicals and infusions and to prevent deterioration due to contact with air.

  In the medical cap using the elastic plug, the support is attached by welding or the like to the mouth of the drug container. In use, a plastic needle equipped with a take-out tube is pierced into the elastic plug, the medicine container is placed on the upper side, and the medical cap is placed on the lower side, so that the infusion in the container can be passed through the take-out tube. Take out.

  Here, in the conventional medical cap, since the outer diameter of the puncture portion of the plastic needle is larger than that of a stainless needle or the like, in the case of needle puncture with the plastic needle, the puncture resistance is large and it is difficult to puncture the needle. There was a problem. In order to solve such a problem, in Patent Documents 1 to 3 below, the mouth plug body (corresponding to the elastic plug body) is provided with a puncture recess for the puncture needle, and the guide cylinder for the insertion guide for the puncture needle is provided in the recess. Is provided. Moreover, the bottom part of the said guide cylinder is formed in cone shape along the bottom face of a recessed part. According to these patent documents, by adopting the configuration as described above, it is possible to puncture even when a plastic needle is used as the puncture needle, and to prevent deformation and dropout of the plug body. Disclosure has been made.

  However, as with the mouthpiece for infusion containers disclosed in Patent Documents 1 to 3, if the bottom surface of the recess is formed in a conical shape, the puncture resistance when the plastic needle is inserted into the mouthpiece cannot be sufficiently reduced. There is. That is, as shown in FIGS. 9 (a) and 9 (b), the size of the recess 103 in the conventional plug body 102 is almost the same as the maximum diameter of the puncture needle, and the needle puncture of the plastic needle 101 is performed. In this case, the entire plug body 102 is bent and deformed by the pressing of the plastic needle, and the recess 103 is distorted. Therefore, as shown in FIG. 9 (c), the puncture portion 104 of the plastic needle 101 starts to be embedded in the plug body 102, and the concave portion 103 is distorted and attached to the puncture portion 104 at the initial stage of needle puncture. To touch. Further, when the plastic needle 101 is further pressed and the base 105 starts to be embedded in the plug body 102, the plug body 102 itself is also distorted, and as a result, the plug body 102 comes into contact with the base section 105. Thus, frictional resistance is generated. Finally, when the puncture portion 104 penetrates the plug body 102, the needle puncture is completed (see FIG. 9D). As described above, in the case of the conventional plug body 101, when the needle is punctured, the plastic needle 101 comes into contact with the plug body 101 so that friction resistance is generated on the plastic needle 101. There is a problem that it becomes puncture resistance and needle puncture cannot be easily performed.

JP 2003-220117 A JP 2003-339821 A JP 2004-49598 A

  The present invention has been made in view of the above problems, and its purpose is to reduce puncture resistance at the time of needle puncture with a puncture needle such as a plastic needle, even for an elastic plug containing a thermoplastic elastomer resin component. Accordingly, it is an object of the present invention to provide an elastic plug that can be easily needled and a medical cap provided with the elastic plug.

  The inventors of the present application have studied an elastic plug and a medical cap provided with the same in order to solve the above-described conventional problems. As a result, the inventors have found that the object can be achieved by adopting the following configuration, and have completed the present invention.

  That is, the medical cap according to the present invention is an elastic plug for closing the opening of the container in order to solve the above-described problem, and the puncture is performed at an arbitrary position on the needle puncture surface of the elastic plug. At least one recess for performing needle puncture of the needle is provided, the bottom surface of the recess has a size equal to or greater than the maximum diameter of the puncture needle, and the opening edge of the recess is the maximum diameter of the puncture needle And when the puncture needle is inserted into the recess, the opening edge of the recess does not contact the entire circumference of the puncture needle.

  According to the above configuration, the needle puncture surface of the elastic plug body is provided with the recess for performing needle puncture with the puncture needle. Furthermore, the bottom surface of the concave portion has a size equal to or larger than the maximum diameter of the puncture needle. For this reason, even when the bottom surface of the concave portion is distorted due to the pressure of the puncture needle during needle puncture, it is possible to suppress excessive contact with the puncture needle and generation of frictional resistance. As a result, the puncture resistance can be reduced, and needle puncture can be easily performed as compared with a conventional elastic plug. Furthermore, the present invention has a structure in which the opening edge of the recess is larger than the maximum diameter of the puncture needle and the opening edge does not contact the entire circumference of the puncture needle when needle puncture is performed. Therefore, the puncture resistance is further reduced, and the ease of needle stick is further improved.

  In the said structure, it is preferable that the bottom face of the said recessed part is a flat surface.

  In the above configuration, it is preferable that the bottom surface of the concave portion is a concave conical surface, and an angle formed with a horizontal plane is greater than 0 ° and 10 ° or less. When the bottom surface of the recess is a concave conical surface, the puncture resistance when the puncture needle is inserted into the elastic stopper is increased. However, in the present invention, in addition to the opening edge of the recess being larger than the puncture needle, the opening edge is not in contact with the entire circumference of the puncture needle when puncturing with the puncture needle. . Further, as described above, since the angle formed with the horizontal plane is set to 10 ° or less, even when the bottom surface of the concave portion is distorted due to the pressure of the puncture needle, the puncture needle is excessively contacted and rubbed. The generation of resistance can be suppressed.

  Moreover, in the said structure, it is preferable that the bottom face of the said recessed part is a concave curved surface, and the curvature radius is 7.3 mm or more. According to this configuration, the bottom surface of the concave portion is formed into a concave curved surface with a radius of curvature of 7.3 mm or more, so that even when the bottom surface of the concave portion is distorted by the pressing of the puncture needle, It can suppress that friction resistance arises by contacting.

  Moreover, in the said structure, it is preferable that a thermoplastic elastomer resin component is included. Even if the elastic plug body containing the thermoplastic elastomer resin component has the same hardness as the elastic plug body made of rubber, the puncture resistance when performing needle puncture with a plastic needle or the like is large. This is because the thermoplastic elastomer resin has a larger amount of bending deformation when puncturing with a plastic needle or the like than rubber. However, according to the configuration of the present invention, the bottom surface of the recess is larger than the maximum diameter of the puncture needle and is formed in a flat shape, and the opening edge and the wall surface of the recess are in contact with the puncture needle during needle insertion. Therefore, even an elastic plug containing the thermoplastic elastomer resin component as described above can be easily punctured with a puncture needle.

  In order to solve the above-described problems, a medical cap according to the present invention includes the elastic plug body having the above-described configuration and a support body that holds the elastic plug body therein.

  The elastic plug of the present invention is provided with at least one recess for performing needle insertion of the puncture needle at an arbitrary position on the needle puncture surface, and the bottom surface of the recess has a size larger than the maximum diameter of the puncture needle. Have. Therefore, even when the bottom surface of the concave portion is distorted due to the pressure of the puncture needle during needle puncture, it is possible to suppress the frictional resistance caused by excessive contact with the puncture needle. The opening edge of the recess is also larger than the maximum diameter of the puncture needle, and has a structure that does not contact the puncture needle during needle puncture. As a result, it is possible to reduce the puncture resistance when the puncture needle is punctured as compared with the conventional elastic plug.

  That is, according to the present invention, for example, even an elastic plug containing a thermoplastic elastomer resin component can reduce puncture resistance when a puncture needle such as a plastic needle is punctured, and can be easily punctured. An elastic plug body and a medical cap equipped with the same can be provided.

It is a cross-sectional schematic diagram for demonstrating the medical cap which concerns on one Embodiment of this invention. It is a cross-sectional schematic diagram which shows typically the elastic stopper in the said medical cap. It is an expanded sectional view showing the crevice in the elastic plug. It is the top view which looked at the said elastic stopper from the needle puncture surface side. It is the top view which looked at the said elastic stopper from the liquid-contacting surface side. It is a cross-sectional schematic diagram showing a mode at the time of puncturing a puncture needle in the recessed part in the said elastic stopper. It is a cross-sectional schematic diagram showing another elastic plug body of the present invention, in which FIG. (A) shows the case where the concave portion is formed in a taper shape, and FIG. This represents the case where a groove is provided. It is a cross-sectional schematic diagram showing the other elastic plug body of this invention, Comprising: The figure (a) represents the case where a recessed part is a concave conical surface, The figure (b) shows the case where a recessed part is a concave curved surface. To express. It is a cross-sectional schematic diagram showing the mode at the time of piercing a puncture needle in the recessed part in the conventional elastic plug body (mouth plug body).

  Embodiments of the present invention will be described below with reference to FIGS. However, parts that are not necessary for the description are omitted, and there are parts that are illustrated in an enlarged or reduced manner for ease of explanation.

  As shown in FIG. 1, the medical cap 10 according to the present embodiment includes an elastic plug body 11, an upper frame portion 12 a that holds the side peripheral portion 22 of the elastic plug body 11 from the needle puncture surface 14 side on the inner wall, and This is a structure having a support 12 having a lower frame portion 12b held by an inner wall from the liquid contact surface 15 side. The “needle puncture surface” refers to the surface on which the medical cap 10 according to the present embodiment is attached to a medical solution bottle, an infusion bottle used for infusion, and the like, and the needle puncture is performed with a puncture needle when taking out the chemical solution or the like. means. The “wetted surface” means a surface that comes into contact with a chemical solution or the like.

  The material constituting the support 12 may be any synthetic resin that has been established for safety as a medical application. Of these, a thermoplastic resin is generally used. Specifically, resins conventionally used for medical use such as polyethylene, polypropylene, and PET (polyethylene terephthalate) resin are preferable, but are not limited thereto. In the case of the pull-top type, as a material constituting the upper frame portion 12a, for example, a thermoplastic elastomer is preferable. More specific examples include olefin-based, styrene-based, polyurethane-based, polyester-based, polyvinyl chloride-based, and polybutadiene-based, but the present invention is not limited to these. Furthermore, you may add arbitrary components, such as a coloring agent, to the support body 12. FIG.

  The upper frame portion 12a of the support 12 may be a pull-top type. Further, in the present embodiment, the lower frame portion 12b is an aspect in which a flange is provided. However, the present invention is not limited to this aspect, and the flange is appropriately omitted as necessary. Also good. Further, the upper frame portion 12a and the lower frame portion 12b may be a support formed integrally.

The entire shape of the elastic plug 11 is cylindrical. The diameter d ₁ of the elastic plug 11 is not particularly limited as long as it can be accommodated in the support 12. Usually, it can set within the range of 12 mm-40 mm. Furthermore, it is possible to the diameter _{d 3} of diameter _{d 2} and wetted surface 15 of Haritogemen 14 is also set as appropriate. d ₂ and _{d 3} can typically be set in the range of 5 mm to 30 mm. In addition, the thickness t of the elastic plug 11 is not particularly limited, but can usually be set within a range of 3 mm to 10 mm. By making the thickness t 3 mm or more, it is possible to prevent the rigidity of the entire elastic plug body 11 from being lowered. On the other hand, by setting the thickness t to 10 mm or less, it is possible to prevent the needle stick with the puncture needle 21 from becoming difficult. However, the present invention is not limited to this shape, and can be appropriately changed to any shape as necessary.

  On the needle puncture surface 14 side of the elastic plug body 11, a stepped portion 17 is provided for preventing the elastic plug body 11 from falling off the support body 12 (see FIGS. 2 and 4). Further, an annular groove 16 is provided on the liquid contact surface 15 side of the elastic plug body 11 so as to be able to be fitted to the support and to prevent the needle plug with the puncture needle 21 from dropping off (FIG. 2). And FIG. 5). However, the elastic plug body 11 is not limited to the form as shown in FIG. 2, and for example, both the needle puncture surface 14 and the liquid contact surface 15 may have a flat surface (however, , Except that a recess is provided on the needle puncture surface 14).

  The puncture needle 21 is not particularly limited, and examples thereof include a bottle needle having a tapered puncture portion 21a at the tip and a cylindrical base portion 21b subsequent thereto. The constituent material of the puncture needle 21 is not particularly limited, and for example, synthetic resin such as ABS (acrylonitrile butadiene styrene) resin, PC (polycarbonate) resin, PMMA (methacrylic) resin, or the like can be used.

  The tip angle θ of the puncture portion 21a is an acute angle and is not particularly limited, but normally, a tip within a range of 20 ° to 60 ° can be used. Further, the maximum diameter of the base portion 21b as the maximum diameter of the puncture needle 21 is not particularly limited, and a diameter of φ3.5 mm to φ5.5 mm is usually used.

  In addition, on the needle puncture surface 14 side of the elastic plug body 11, one recess 13 for performing needle puncture of the puncture needle 21 is provided at the center of the needle puncture surface 14 (see FIGS. 2 to 4). Further, on the side of the needle puncture surface 14, a needle puncture portion 23 for performing needle puncture with a metal needle at the time of co-injection for mixing and adjusting a plurality of medicines is provided separately from the recess 13 (see FIG. 2 and FIG. 2). (See FIG. 4). The needle puncture portion 23 performs needle puncture with a metal needle, and has a smaller outer diameter than a plastic needle or the like and is relatively easy to puncture, so that a cross-sectional shape having a conical shape can be used. Each needle stab portion 23 is located concentrically outside the recess 13 provided at the center of the elastic plug body 11. Further, the needle stab portions 23 are provided at equal intervals. In the present invention, it is also possible to use the recess 13 for needle sticking with a metal needle at the time of mixed injection. In this case, a plurality of recesses 13 may be provided at arbitrary positions without providing the needle stick 23.

  The bottom surface 18 of the recess 13 is flat and the size thereof is the same as or larger than the maximum diameter of the puncture needle 21. The opening edge 20 of the recess 13 is also larger than the maximum diameter of the puncture needle 21 and has a size that prevents the opening edge 20 from coming into contact with the puncture needle 21 when the recess 13 is needle-punctured. ing. More specifically, as shown in FIG. 3, the diameter r of the opening edge 20 is larger than the maximum diameter of the puncture needle 21. By adopting such a configuration, needle puncture with the puncture needle 21 can be easily performed as compared with a conventional elastic stopper. Note that the needle insertion into the elastic plug body 11 by the puncture needle 21 is completed in a state where the puncture portion 21a penetrates the elastic plug body 11 and the base portion 21b is embedded in the elastic plug body 11, as described later. Therefore, in the present embodiment, the maximum diameter of the puncture needle 21 means the maximum diameter of the base portion 21b.

  Moreover, since the thickness becomes thin in the said part by providing the recessed part 13 in the needle stick surface 14, the needle stick of the puncture needle 21 can be performed easily. Here, from the viewpoint of improving the ease of needle sticking of the puncture needle 21, a mode in which the entire elastic stopper 11 is thinned is also conceivable. However, in the case of this aspect, the rigidity of the entire elastic plug 11 is lowered. For this reason, there is a problem in that the elastic stopper 11 is greatly bent by the pressing of the puncture needle 21 when the needle is inserted by the puncture needle 21. However, in the present embodiment, since the concave portion 13 is provided only in the portion where needle sticking is performed, needle sticking can be facilitated without reducing the rigidity of the elastic plug body 11.

  The mechanism by which the recess 13 reduces the puncture resistance is as follows. That is, as shown in FIGS. 6A and 6B, when the puncture needle 21 is positioned on the flat bottom surface 18 of the recess 13 and the elastic plug body 11 is pressed by the puncture needle 21, the elastic plug body 11. Deforms and bends. Thereafter, as shown in FIG. 6 (c), the puncture portion 21 a of the puncture needle 21 starts to be embedded in the elastic plug body 11. When the puncture needle 21 is further pressed, the base portion 21b of the puncture needle 21 starts to be embedded in the elastic plug body 11. As a result, the elastic plug body 11 is distorted, but the opening edge 20 of the recess 13 is sized so as not to come into contact with the puncture needle 21 during needle sticking, so that friction between the opening edge 20 and the base 21b occurs. Resistance can be prevented from occurring. Finally, when the puncture portion 21a passes through the elastic plug body 11 and is exposed to the liquid contact surface 15 side, and the base portion 21b is embedded in the elastic plug body 11, the needle puncture is completed (FIG. 6D). )reference). As described above, by adopting a configuration in which the bottom surface 18 of the recess 13 is flat and has a size such that the opening edge 20 does not come into contact with the puncture needle 21 during needle stick, Compared with the body, the puncture resistance can be reduced, and the ease of needle stick can be improved.

  The edge 19 on the bottom surface 18 of the recess 13 is preferably curved. In this case, the radius of curvature in the cross section perpendicular to the needle puncture surface 14 is preferably in the range of 0.3 mm to 3 mm, more preferably in the range of 0.4 mm to 2 mm, and particularly preferably in the range of 0.5 mm to 1 mm. . By setting the radius of curvature to 0.3 mm or more, even when the concave portion 13 is distorted by the puncture needle 21 when the puncture needle 21 punctures, the wall surface 25 of the concave portion 13 does not fall toward the puncture needle 21. Moreover, the distortion can be reduced. As a result, it is possible to prevent the wall surface 25 of the concave portion 13 from coming into contact with the puncture needle 21 and to generate frictional resistance, thereby making it easier to puncture with the puncture needle. On the other hand, by setting the radius of curvature to 3 mm or less, the wall surface 25 of the concave portion 13 becomes a gentle but nearly inclined surface, and the boundary between the concave portion 13 and the needle piercing surface 14, that is, the opening edge portion. It can be avoided that 20 becomes obscured. In the present embodiment, the case where the edge portion 19 is curved has been described as an example. However, the present invention is not limited to this, and the bottom surface 18 and the wall surface 25 have at least an acute angle. If it does not form. A mode in the case where the edge portion is not curved will be described in detail later.

The depth h ₁ of the recess 13 is preferably in the range of 0.5 mm to 3 mm, more preferably in the range of 0.8 mm to 2.5 mm, and particularly preferably in the range of 1 mm to 2 mm. By the depth h ₁ above 0.5 mm, to reduce the substantial thickness for passing the puncture needle 21, thereby improving the ease of needle sticks. On the other hand, by setting the depth h ₁ to 3 mm or less, it is possible to prevent the thickness of the needle plug portion of the elastic plug body 11 from being thinned and to prevent the retention of the puncture needle 21 after needle insertion from being reduced. .

  The elastic plug 11 is not particularly limited as long as it is made of a material that can be pierced with a puncture needle. Examples of such a material include rubber and thermoplastic elastomer resin. The rubber is not particularly limited, and examples thereof include natural rubber, isoprene rubber, butadiene rubber, styrene-butadiene rubber, and isoprene-isobutylene rubber. Moreover, it does not specifically limit as a thermoplastic elastomer, For example, an olefin type, a styrene type, a polyurethane type, a polyester type, a polyvinyl chloride type, a polybutadiene type etc. can be illustrated. Among them, thermoplastic elastomers (SEBS, SEPS, HSBR, SEBR, CEBC) obtained by hydrogenating conjugated diene-based thermoplastic elastomers are preferable.

  The characteristic of the elastic plug 11 is not particularly limited as long as it has a hardness that allows the puncture needle 21 to penetrate. Moreover, what has a shape retainability of the grade which does not deform | transform easily or break at the time of normal storage is preferable. The A hardness of the elastic plug 11 is preferably in the range of 5 to 50 degrees, more preferably in the range of 10 to 40 degrees, and more preferably 30 degrees in the measurement by the durometer hardness test defined in JIS K6253. A range of ˜40 degrees is particularly preferable. By setting the A hardness to 5 degrees or more, the puncture needle 21 can be held in a state of penetrating the elastic plug body 11. On the other hand, by setting the A hardness to 50 degrees or less, it is possible to prevent infusion or the like from leaking from the needle stick portion of the puncture needle 21.

  Here, when the elastic plug 11 includes the thermoplastic elastomer resin component, the elastic plug including the thermoplastic elastomer resin component is more plastic needle or the like even if the hardness is the same as the elastic plug made of rubber. The puncture resistance is large when the needle is punctured, so it is difficult to puncture the needle. This is because, when a thermoplastic elastomer resin component is contained, the elastic modulus of the elastic plug body 11 is increased, and the concave portion to be pressed and punctured with a puncture needle such as a plastic needle is distorted and attached to the puncture needle. However, as in the present embodiment, the recess 13 has a flat bottom surface 18 and has a structure in which the opening edge 20 and the wall surface 25 do not come into contact with the puncture needle 21 during needle sticking. Even an elastic plug containing an elastomer resin component can facilitate needle sticking with the puncture needle 21.

  The thermoplastic elastomer resin is an extremely hygienic material compared to rubber, but depending on the chemical used, the liquid contact surface 15 of the elastic plug 11 may be laminated. For laminating, the same type of resin as the support 12 or the container to be attached is generally used. Thereby, it can be set as the material of the property which is the same as that of the liquid contact surface 15 of the inside and the elastic stopper 11 which a chemical | medical solution contacts.

  Moreover, it does not specifically limit as a manufacturing method of the elastic plug body 11, For example, it can manufacture by the compression molding and injection molding performed while crushing the material containing a thermoplastic elastomer resin etc.

  The medical cap according to the present embodiment can be used by being attached to, for example, a container of a type that takes out a chemical solution with a needle. Specifically, the medical cap can be used as the take-out part in a medical bottle, a medical bag, or the like having a main body part for containing the chemical liquid and a take-out part for taking out the chemical liquid with a needle. As a result, it is possible to reduce the puncture resistance at the time of puncture of the puncture needle while preventing the leakage of the liquid and maintaining the holding force against the needle removal, and improve the ease of needle puncture as compared with the conventional medical cap. .

  The elastic plug and the medical cap according to the present invention are not limited to the above-described embodiments, and various modifications can be made within the scope of the effects of the present invention. For example, it is possible to adopt an embodiment as shown in FIGS. 7 (a) and 7 (b).

  That is, as shown to Fig.7 (a), the recessed part 31 of an elastic plug body may have a taper-shaped cross-sectional shape. In the case of this aspect, the bottom surface 18 may be the same size as the maximum diameter of the puncture needle 21. Even with such a structure, when the puncture needle 21 is punctured, it is possible to prevent the opening edge 20 and the wall surface 32 from coming into contact with the puncture needle 21 and to reduce the puncture resistance. Further, compared to the case where the wall surface of the recess is perpendicular to the bottom surface, it is possible to improve the ease of molding by the mold. The angle α formed by the bottom surface 18 and the wall surface 32 of the recess 31 is preferably in the range of 100 ° to 170 °, more preferably 115 ° to 155 °, and particularly preferably 130 ° to 140 °. .

Further, as shown in FIG. 7B, an embodiment in which an annular groove 34 is provided at the edge of the bottom surface 18 in the recess 33 may be used. Even with such a structure, when the puncture needle 21 is punctured, it is possible to prevent the opening edge 20 and the wall surface 32 from coming into contact with the puncture needle 21 and to reduce the puncture resistance. While the depth _{h 2} of the annular groove 34 is not particularly limited, but is preferably in the range of 0.5Mm～2.5Mm, more preferably from 1 mm to 2 mm, particularly preferably 1.2Mm～1.8Mm. The groove width w of the annular groove 34 is not particularly limited, but is preferably in the range of 0.2 mm to 2 mm, more preferably 0.5 mm to 1.8 mm, and particularly preferably 0.8 mm to 1.5 mm. is there.

  Furthermore, as shown in FIG. 8A, the elastic plug according to the present invention may be provided with a recess 35 whose bottom surface 36 is a concave conical surface. At this time, the angle β formed by the bottom surface 36 and the horizontal plane is preferably greater than 0 ° and 10 ° or less, and more preferably greater than 0 ° and 5 ° or less. When the bottom surface 36 of the recess 35 is a concave conical surface, the puncture resistance when the puncture needle 21 is inserted into the elastic stopper is increased. However, in the present invention, the opening edge 20 of the recess 35 corresponds to the puncture needle 21. In addition to being larger than the maximum diameter, the opening edge 20 does not contact the entire circumference of the puncture needle 21 when the needle is punctured by the puncture needle 21. Further, since the angle formed with the horizontal plane is also set to 10 ° or less, even when the bottom surface 36 of the concave portion 35 is distorted due to the pressing of the puncture needle 21 during needle puncture, the puncture needle 21 is excessively contacted to cause frictional resistance. Can be suppressed. Moreover, it is preferable that the bottom surface 36 becomes a concave conical surface toward the center direction. As a result, the needle insertion position of the puncture needle 21 can be guided at the center of the bottom surface 36. Further, the edge 37 on the bottom surface 36 of the recess 35 may be curved. In this case, the numerical range of the radius of curvature in the cross section perpendicular to the needle puncture surface 14 is the same as that described above.

  Moreover, the aspect provided with the recessed part 38 whose bottom face 39 is a concave curved surface may be sufficient as the elastic plug body which concerns on this invention, as shown in FIG.8 (b). At this time, it is preferable that the curvature radius R of the bottom surface 39 is 14.5 mm or more. The upper limit of the radius of curvature R is not particularly limited unless the bottom surface 39 is flat. By making the bottom surface of the recess 38 a concave curved surface with a radius of curvature R of 14.5 mm or more, even when the bottom surface 39 of the recess 38 is distorted by the pressing of the puncture needle 21 during needle puncture, the puncture needle 21 is excessively distorted. It can suppress that friction resistance arises by contacting. Furthermore, the edge 40 on the bottom surface 39 of the recess 38 may be curved. In this case, the numerical range of the radius of curvature in the cross section perpendicular to the needle puncture surface 14 is the same as that described above.

  Hereinafter, preferred embodiments of the present invention will be described by way of example. However, the materials, blending amounts, and the like described in the examples do not limit the scope of the present invention only to those unless otherwise limited.

Example 1
In this embodiment, the medical cap having the structure shown in FIG. 1 was used. Polypropylene was used as the material for the upper and lower frame parts of the support. As the material of the elastic plug, a styrene thermoplastic elastomer (grade for plug) was used. Furthermore, a two-color injection molding machine (trade name: DC100-200) manufactured by Nissei Plastic Industry Co., Ltd. was used as a molding machine for molding the support.

The shape and dimensions of the elastic plug used in this example are as follows.
Elastic plug diameter d ₁ : 23 mm
Needle penetration surface diameter d ₂ : 16.5 mm
Wet surface diameter d ₃ : 20 mm
Elastic plug thickness t: 6mm
Concave diameter r: 5 mm
Depth depth h ₁ : 1 mm
Curvature radius of edge at bottom of recess: 1mm
Hardness (JIS A): 35 degrees

(Example 2)
In this example, a medical cap according to this example was produced in the same manner as in Example 1 except that an elastic plug having a right edge at the bottom of the recess was used. did.

The shape and dimensions of the elastic plug used in this example are as follows.
Elastic plug diameter d ₁ : 23 mm
Needle penetration surface diameter d ₂ : 16.5 mm
Wet surface diameter d ₃ : 20 mm
Elastic plug thickness t: 6mm
Concave diameter r: 5 mm
Depth depth h ₁ : 1 mm
Hardness (JIS A): 35 degrees

(Comparative Example 1)
In this comparative example, a medical cap according to this comparative example was produced in the same manner as in Example 1 except that an elastic plug having a conical recess was used.

The shape dimensions of the elastic plug used in this comparative example are as follows.
Elastic plug diameter: 23 mm
Needle penetration surface diameter: 16.5 mm
Diameter of wetted surface: 20mm
Elastic plug body thickness: 6mm
Concave diameter: 4.6 mm
Depth of recess: 1mm
Hardness (JIS A): 35 degrees

(Measurement of hardness (JIS-A))
About the said measured value of A hardness of each elastic stopper used in the said Example and comparative example, it measures by the durometer hardness test defined in JIS-K6253.

(Puncture resistance test)
The medical caps obtained in the examples and comparative examples were sterilized at 110 ° C. for 30 minutes by an autoclave. Twenty samples of such medical caps were prepared, and each elastic stopper was punctured using Terumo Corporation's terfusion fusion set (product number) TK-U200L as a puncture needle (bottle needle). The puncture resistance was examined.

  Specifically, each medical cap is set in a tension / compression tester (manufactured by Imada Manufacturing Co., Ltd., trade name: SV55), and the tester is placed on the needle puncture surface side of the elastic stopper in each medical cap. The following puncture needle attached to was vertically stabbed. The moving speed at the time of piercing the puncture needle was 200 mm / min, and the penetration force (unit: N) until the base of the puncture needle penetrated was measured. As the puncture needle, a puncture portion with a length of 14 mm and a base length of 15 mm was used. Further, the maximum diameter of the puncture needle (maximum diameter of the base portion) was 4.6 mm. The results are shown in Table 1 below.

(Puncture needle holding force test)
The medical caps obtained in the examples and comparative examples were sterilized at 110 ° C. for 30 minutes by an autoclave. Twenty samples of such medical caps were prepared, and the holding force when the same puncture needle as that used in the puncture resistance test was inserted into the elastic plug was examined.

  Each medical cap was set in a tension / compression tester (manufactured by Imada Manufacturing Co., Ltd., trade name: SV55), and the puncture needle attached to the tester was pierced perpendicularly to the elastic stopper of the medical cap. Thereafter, the puncture needle was raised at a speed of 200 mm / min, and the force (unit: N) when the puncture needle was removed from the elastic plug was measured. In the measurement, the maximum value, the minimum value, the average value, and the standard deviation were obtained. The results are shown in Table 2 below.

(Puncture needle leak test)
The medical caps obtained in the examples and comparative examples were sterilized at 110 ° C. for 30 minutes by an autoclave. Next, each medical cap is attached to the test pressure can body, and a Terumo Corporation connection tube (trade name: TC-00503B) is inserted into the recess of the elastic stopper in the medical cap. Left for hours. Thereafter, the needle was removed, and the presence or absence of liquid leakage from the recess of the elastic plug was examined. The results are shown in Table 3 below. The number of specimens was 300.

(result)
As is clear from Tables 1 to 3, the medical cap according to Examples 1 and 2 maintains the holding force of the puncture needle and suppresses the occurrence of liquid leakage while performing needle puncture of the puncture needle. The puncture resistance could be reduced. In contrast, the medical cap according to Comparative Example 1 had good puncture needle retention and liquid leakage, but had high puncture resistance, so compared with the medical caps of Examples 1 and 2. Therefore, needle sticking was not easy.

DESCRIPTION OF SYMBOLS 10 Medical cap 11 Elastic plug body 12 Support body 12a Upper frame part 12b Lower frame part 13, 31, 33, 35, 38 Recessed part 14 Needle stick surface 15 Liquid contact surface 16 Annular groove 17 Step part 18, 36, 39 Bottom face 19, 37, 40 Edge portion 20 Open edge portion 21 Puncture needle 21a Puncture portion 21b Base portion 22 Side peripheral portions 25, 32 Wall surface 23 Needle puncture portion 34 Annular groove

Claims (6)

An elastic stopper for closing the opening of the container,
At least one recess for performing needle insertion of the puncture needle is provided at an arbitrary position on the needle insertion surface of the elastic plug,
The bottom surface of the recess has a size equal to or greater than the maximum diameter of the puncture needle;
An elastic plug in which the opening edge of the recess is larger than the maximum diameter of the puncture needle, and the opening edge of the recess does not contact the entire circumference of the puncture needle when the puncture needle is inserted into the recess. body.   The elastic plug body according to claim 1, wherein a bottom surface of the recess is a flat surface.   The elastic plug body according to claim 1, wherein the bottom surface of the concave portion is a concave conical surface, and an angle formed with a horizontal plane is greater than 0 ° and 10 ° or less.   The elastic plug body according to claim 1, wherein a bottom surface of the concave portion is a concave curved surface, and a radius of curvature thereof is 7.3 mm or more.   The elastic plug body according to claim 1 or 2, comprising a thermoplastic elastomer resin component. A medical cap comprising: the elastic plug body according to any one of claims 1 to 5; and a support body that holds the elastic plug body therein.

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