JP5980021B2 - Medical cap and method for manufacturing the same - Google Patents

Description

  The present invention relates to a medical cap used for drug containers such as infusion containers, blood collection tubes and vials, and a method for producing the same. In particular, the present invention relates to a medical cap provided with an elastic stopper that can be inserted into a needle for medical use and a method for manufacturing the same.

  In order to be able to take out the drug solution with a needle, the drug container used in the medical field, such as a drug solution bottle or an infusion bottle for infusion, has a rubber plug or an elastic plug (for example, inside the outer frame). , Rubber, elastomer resin, etc.) are used. In the latter cap, the outer frame is attached by welding or the like to the mouth of the drug container. Then, at the time of use, an infusion needle in the container is taken out through the take-out tube by inserting an injection needle equipped with a take-out tube into the elastic plug, placing the drug container on the upper side, and placing the cap on the lower side. In addition, such a medical cap is required to have hermeticity in order to prevent leakage of chemicals and infusions and to prevent deterioration due to contact with air.

  As the medical cap, for example, the liquid contact surface of the elastic plug body and the upper portion of the bottom surface holding portion of the outer frame body are fused, and the side surface portion of the elastic plug body and the side periphery of the outer frame body The thing of the structure which contacts the inner wall of a part in the non-fusion | fusion state is proposed (refer the following patent document 1). According to Patent Document 1, it is disclosed that rubber characteristics are improved and resealability can be improved.

  However, in the case of a conventional medical cap, the close contact between the elastic plug body and the outer frame body may not be sufficient. In such a medical cap, the position of the elastic stopper body and the outer frame body shifts during needle sticking, and a gap is created between them. For this reason, the second needle is stuck, or needle sticking is performed again. There is a problem that it is difficult to do.

  In order to solve the above-described problem, Patent Document 2 below discloses a medical cap in which the liquid contact surface of the elastic plug body has a convex slope toward the center of the circle. Since the medical cap is in a state where pressure is applied from the outer frame body to the horizontal component of the elastic plug body, it is possible to improve resealability and prevent needle removal.

  Further, in Patent Document 3 below, a thermoplastic elastomer having a hardness of 30 to 55 degrees and a compression set of 40% or less, and an outer periphery of the thermoplastic elastomer over a thickness of 40% or more in a ring shape or a cylindrical shape A joint stopper for a chemical solution container is disclosed which is made of a polyolefin-based resin formed integrally with the above. And according to the said patent document 3, even if a sealing performance improves and a bottle needle is extracted, it describes that a chemical | medical solution does not leak outside.

  However, even the medical caps and the like disclosed in Patent Documents 2 and 3 have a problem that the prevention of occurrence of liquid leakage and needle omission is insufficient.

JP-A-2005-118185 JP-A-8-317961 JP 2004-215860 A

  The present invention has been made in view of the above problems, and an object of the present invention is a medical cap having an elastic plug and an outer frame body that holds the elastic plug inside. Providing medical caps with excellent sealing performance, such as prevention of voids due to frame misalignment, no liquid leakage during needle sticking, and excellent retention and restoring force against needle removal, and methods for manufacturing the same There is to do.

  The inventors of the present application have studied a medical cap and a manufacturing method thereof in order to solve the 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 a medical cap having an elastic plug and an outer frame that accommodates the elastic plug in order to solve the above-described problems. The body includes a first support portion that surrounds and accommodates the elastic plug body with a plurality of annular walls, an outer wall that surrounds the annular wall, and a second support portion that protrudes from an inner surface of the outer wall. The projecting portion is welded to a contact surface of the annular wall in a state where the annular wall and the elastic plug body are pressed, and the plurality of the annular walls are also attached to the elastic plug body. The elastic plug body is contacted and welded in the gap, and pressure is applied from the annular wall and the projecting portion.

  According to the above configuration, the elastic plug has a structure in which the elastic plug is welded in contact with the projecting portion of the second support portion in the gap between the plurality of annular walls. Further, the projecting portion has a structure welded even on the contact surface with the annular wall. That is, the medical cap having the above-described structure has a structure in which the elastic plug body and the second support portion, and the first support portion and the second support portion are welded to each other on the respective contact surfaces. Therefore, for example, when a needle is inserted into the elastic plug body, it is possible to prevent a gap from being generated due to a positional shift between the elastic plug body and the outer frame body. Furthermore, the occurrence of liquid leakage can be prevented and sealing performance can be ensured. In addition, since the elastic plug body is pressurized from the annular wall of the first support part and the protruding part of the second support part, it has excellent holding force and restoring force against needle removal, and further resealability after needle removal. Is also good.

  In the above configuration, it is preferable that the elastic plug body and the annular wall are welded to each other at the contact surface. With this configuration, since the elastic plug is welded not only to the second support part but also to the first support part, the positional displacement of the elastic plug and the occurrence of liquid leakage during needle sticking to the elastic plug are further reduced. This can be prevented and the sealing performance can be further improved.

  In order to solve the above-described problem, a method for manufacturing a medical cap according to the present invention is the method for manufacturing a medical cap described above, wherein the elastic plug is housed inside the annular wall. A step for producing one support portion, and the first support portion in which the elastic stopper is accommodated inside the annular wall is placed in a lower mold, and a pressure for pressing the annular wall in the first support portion A mold is closed in a state where the annular wall is pressed in the center direction by using an upper mold provided with a portion, and a molding resin is formed in the cavity. A step of injecting and forming the second support portion including an outer wall surrounding the first support portion and a projecting portion projecting from an inner surface of the outer wall.

  In the above-described method, first, the first support part that houses the elastic plug body inside the annular wall is manufactured, and then the second support part is formed. The molding is performed while pressing the annular wall in the center direction. For this reason, in the manufactured medical cap, the elastic plug is in a state in which pressure is applied directly from the protruding portion and indirectly through the annular wall. As a result, the above-described method can produce a medical cap that is excellent in holding force and restoring force against needle removal and further improved in resealability after needle removal.

  Moreover, the 2nd support part shape | molded by the said method has the structure where the protrusion part and the annular wall welded in the contact surface. Further, the projecting portion is in contact with the elastic plug in the gap between the annular wall and welded at this contact portion. That is, according to the above method, it is possible to manufacture a medical cap having a structure in which the elastic plug body and the second support portion and the first support portion and the second support portion are welded to each other. As a result, for example, when needle sticking into the elastic plug body, the gap between the elastic plug body and the outer frame body is prevented from being generated, and the occurrence of gaps and liquid leakage can be prevented, thereby providing a medical cap with excellent airtightness.

  In the above method, as the upper mold, a mold provided with a ring portion that presses the peripheral edge of the elastic plug when the upper mold and the lower mold are closed. Is preferred. This prevents the molten resin from flowing into the gap between the elastic plug and the upper mold when the molten resin is injected into the cavity formed by the upper mold and the lower mold closed. As a result, it is possible to prevent the second support portion from being molded so as to cover the needle stick surface or the liquid contact surface of the elastic plug.

  In the above method, the step of producing the first support portion in which the elastic plug body is accommodated inside the annular wall includes the first support portion in a state where the elastic plug body is placed inside the mold. It may be a step of producing a first support portion in which the elastic plug body and the annular wall are welded at the contact surface. As a result, the elastic plug body can be welded not only to the second support portion but also to the annular wall in the first support portion, so that the displacement of the elastic plug body at the time of needle sticking to the elastic plug body and the occurrence of liquid leakage are prevented. It is possible to produce a medical cap that is further prevented and that has excellent sealing properties.

  Further, in the above method, the step of producing the first support portion in which the elastic plug body is accommodated inside the annular wall includes the step of forming the first stopper and forming the elastic plug inside the annular wall. It may be a step of producing a first support part in which the elastic plug and the annular wall are not welded to each other by accommodating the body.

  The medical cap of the present invention includes an elastic plug and an outer frame that holds the elastic plug, and the outer frame surrounds and accommodates the elastic plug with a plurality of annular walls. 1 support part, and the 2nd support part provided with the protrusion part which presses the said annular wall and an elastic stopper. The projecting portion is welded to the contact surface of the annular wall, and is also in contact with and welded to the elastic plug body in the gap between the plurality of annular walls. For this reason, for example, when a needle is inserted into the elastic plug, it is possible to prevent a gap from being generated due to a positional shift between the elastic plug and the outer frame. Furthermore, the occurrence of liquid leakage can be prevented and sealing performance can be ensured. In addition, since the pressure is applied directly from the projecting part and indirectly through the annular wall, the elastic plug body has excellent holding force and restoring force against needle removal, and also has good resealability after needle removal. is there.

  The manufacturing method of the medical cap of the present invention is to form the second support part after producing the first support part containing the elastic plug inside the annular wall, and the second support part. Is formed while pressing the annular wall in the center direction. Therefore, it is possible to obtain a medical cap in which the elastic plug is directly applied from the projecting portion and indirectly through the annular wall. As a result, the holding force and restoring force against needle removal are excellent, and the resealability after needle removal can be improved. Moreover, in the said method, the protrusion part of a 2nd support part can be made into the structure welded in the contact surface with an annular wall. Furthermore, since a plurality of annular walls are provided, the projecting portion can be structured to contact and weld with the elastic plug body in the gaps between the plurality of annular walls. That is, according to the above method, a medical cap having a structure in which the elastic plug body and the second support portion and the first support portion and the second support portion are welded to each other can be manufactured. When the needle is punctured, the gap between the elastic plug body and the outer frame body is prevented from occurring, and the occurrence of voids and liquid leakage can be prevented, thereby providing a medical cap having excellent airtightness.

It is a section perspective view showing the medical cap concerning one embodiment of the present invention, and the figure (a) expresses the case where a flange part is provided, and the figure (b) expresses the case where a flange part is not provided. It is a cross-sectional schematic diagram for demonstrating the outer frame body provided with the elastic plug body in the said medical cap, Comprising: The same figure (a) is provided with the elastic plug body integrally inside the annular wall in the 1st support part. FIG. 2B shows only the first support portion with the elastic plug body omitted. In the medical cap, the first support part and the second support part are schematic views showing a state where the annular wall and the projecting part are welded. It is a cross-sectional schematic diagram for demonstrating the 2nd support part in the said medical cap. It is a cross-sectional schematic diagram for demonstrating the manufacturing method of the said medical cap. It is a cross-sectional schematic diagram for demonstrating the manufacturing method of the said medical cap. It is a cross-sectional schematic diagram for demonstrating the manufacturing method of the said medical cap. It is explanatory drawing of the 2nd upper metal mold | die used when shape | molding the 2nd support part in the said medical cap, Comprising: The same figure (a) is a top view when it sees from the inside, The same figure (b) It is AA arrow sectional drawing of the figure (a). It is a schematic diagram showing the positional relationship of the press part and annular wall in the said 2nd upper metal mold | die at the time of shaping | molding of a said 2nd support part. It is explanatory drawing of the 2nd upper metal mold | die used when shape | molding the 2nd support part in the said medical cap, Comprising: The same figure (a) is a top view when it sees from the inside, The same figure (b) It is BB arrow sectional drawing of the figure (a).

(Medical cap)
The medical cap according to the present embodiment 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. FIG. 1 is a schematic cross-sectional view for explaining a medical cap according to the present embodiment. FIG. 2 is a schematic cross-sectional view for explaining an outer frame body provided with an elastic plug body in the medical cap. FIG. 2A shows an elastic plug body inside the annular wall in the first support portion. Represents the state in which is integrally provided, and FIG. 4B shows only the first support portion without the elastic plug body. FIG. 3 is a schematic diagram showing a state in which the first support portion and the second support portion are welded at the contact portion between the annular wall and the protruding portion. FIG. 4 is a schematic cross-sectional view for explaining a second support portion in the medical cap.

  As shown in FIG. 1A, the medical cap 10 according to the present embodiment includes at least an outer frame body 1 and an elastic plug body 2. The outer frame body 1 can hold the elastic plug body 2 therein, and further includes at least a first support portion 11 and a second support portion 12.

  The first support portion 11 includes at least an annular frame portion 13 and a plurality of annular walls 14 provided to stand on the annular frame portion 13 at a predetermined interval. The plurality of annular walls 14 surround and accommodate the elastic plug 2.

  As shown in FIG. 2B, a plurality of the annular walls 14 are arranged in an annular shape. Moreover, each annular wall 14 is arrange | positioned in the state mutually spaced apart. The separation distance between the adjacent annular walls 14 is not particularly limited, and can be appropriately set according to the diameter of the medical cap 10 and the number of the annular walls 14. However, the annular walls 14 are preferably arranged at equal intervals. As a result, it is possible to prevent the bias applied to the elastic plug 2 via the annular wall 14 from being biased. Further, the number of the annular walls 14 is not particularly limited, and can be set as necessary. For example, the annular walls 14 may be arranged to form a pair on a diagonal line.

  The annular wall 14 is welded on the contact surface with the elastic plug body 2, whereby the first support portion 11 and the elastic plug body 2 can be integrated. However, in the present invention, the annular wall 14 and the elastic plug 2 need not be welded. The “welding” is a result of melting the surface of the elastic plug body 2 in contact with the heat of the molten resin injected when the first support portion 11 is molded by injection molding or the like, as will be described later. This means that the first support portion 11 and the elastic plug body 2 are in a state of being joined at the contact surface after the first support portion 11 is molded.

  One end portion of the annular wall 14 is welded to the end portion of the pressing surface of the protruding portion 31 (details will be described later) of the second support portion 12 (see FIG. 3). The other end of the annular wall 14 is welded to the end of the pressing surface of the other protruding portion 31 adjacent to the protruding portion 31. Thereby, the 2nd support part 12 can be combined with the 1st support part 11, and the drop-off of the 2nd support part 12 can be prevented. The term “welding” as used herein refers to the surface of the annular wall 14 of the first support portion 11 in contact with the heat of the molten resin injected when the second support portion 12 is molded by injection molding or the like. As a result of melting, it means that after the second support portion 12 is molded, the second support portion 12 is in a coupled state on the contact surface between the annular wall 14 and the projecting portion 31.

  The thickness of the annular wall 14 is not particularly limited, but is preferably in the range of 0.1 mm to 2.5 mm, and more preferably in the range of 0.2 mm to 1 mm. Further, the width of the annular wall 14 and the distance between the gaps between the adjacent annular walls 14 can be appropriately set according to the number and the size of the elastic plug body 2. The width of the annular wall 14 is usually preferably in the range of 1.5 mm to 37 mm, and more preferably in the range of 2 mm to 30 mm. Moreover, the distance between the gaps between the adjacent annular walls 14 is usually preferably in the range of 0.3 mm to 30 mm, and more preferably in the range of 1 mm to 20 mm. By setting the distance of the gap to 0.3 mm or more, when the annular walls 14 are pressed in the center direction, contact between adjacent annular walls 14 can be avoided. On the other hand, the bias of the pressure applied to the elastic plug 2 can be reduced by setting the distance of the gap to 30 mm or less.

  The height of the annular wall 14 is not particularly limited. However, when the elastic plug body 2 is accommodated therein as shown in FIG. 2 (a), it is preferably the same as or higher than the height of the elastic plug body 2. . Thereby, the annular wall 14 can be accommodated so as to cover the side peripheral surface 23 of the elastic plug body 2, and pressure can be effectively applied to the elastic plug body 2. Although the height of the annular wall 14 depends on the height of the elastic plug body 2, it is usually preferably in the range of 2.5 mm to 14 mm, and more preferably in the range of 3 mm to 11 mm.

  Further, the shape of the annular wall 14 is not particularly limited. For example, as shown in FIG. 2B, the annular wall 14 may have a shape that tapers as the cross-sectional shape of the annular wall 14 approaches the top. Thereby, as will be described later, it is possible to easily form the protruding portion 31 that can apply pressure to the elastic plug body 2. On the other hand, the thickness of the bottom of the annular wall 14 may be equal to or thinner than the top. Thereby, the pressure applied to the elastic plug 2 can be increased even at the bottom of the annular wall 14. In addition, the thickness of the annular wall 14 can be appropriately set within the aforementioned numerical range.

  A mounting portion 15 that allows the elastic plug 2 to be mounted is provided on the annular frame portion 13 (the bottom portion of the annular wall 14). The mounting portion 15 is provided so as to project from the annular wall 14 in the center direction. Thereby, the peripheral part 24 of the needle puncture surface 22 of the elastic plug body 2 can be supported. As a result, it is possible to prevent the elastic plug body 2 from being pushed out of the outer frame body 1 to the outside on the side of the needle puncture surface 22. Furthermore, the mounting portion 15 may be provided with an annular ridge that enables fitting with the elastic plug body 2. Thereby, position shift and dropping of the elastic plug body 2 can be further prevented. In the present embodiment, the case where the mounting portion 15 is annular is illustrated, but the present invention is not limited to this. For example, the aspect which provided the several mounting part with the predetermined space | interval may be sufficient. In this case, the separation distance between the adjacent placement portions is not particularly limited as long as the elastic plug body 2 can be supported to the extent that the elastic plug body 2 is not pushed out from the outer frame body 1. Since the elastic plug 2 is welded to a protruding portion 31 described later, the mounting portion 15 is omitted when it is desired to increase the exposed area of the needle piercing surface 22 when the diameter of the elastic plug 2 is small. May be.

  As shown in FIGS. 3 and 4, the second support portion 12 has a structure in which an outer wall 32 surrounding the annular wall 14 and a plurality of projecting portions 31 are provided on the inner side surface of the outer wall 32. is there. Further, as shown in the figure, the top of the outer wall 32 has an outer side of the second support portion 12 for facilitating the joining by means such as welding with a mouth portion of a drug container such as an infusion container, a blood collection tube or a vial. An overhanging flange portion 17 is provided. However, this invention is not limited to this, For example, as shown in FIG.1 (b), the medical cap 10 'of the aspect in which the flange part 17 is not provided may be sufficient.

  The thickness of the outer wall 32 is not particularly limited as long as the protruding portions 31 are connected to each other and the shape of the second support portion 12 can be maintained.

  A plurality of the protruding portions 31 are provided so as to protrude from the inner side surface of the outer wall 32 and are arranged apart from each other. The protruding portions 31 are spaced apart from each other because a pressing portion (details will be described later) for pressing the annular wall 14 when the second support portion 12 is formed is provided in the upper mold. It is because it has been.

  Further, as shown in FIG. 4, a plurality of protruding portions 36 are provided on the pressing surface of the protruding portion 31 in the second support portion 12, and the protruding portions 36 are located in the gaps between the plurality of annular walls 14. positioned. And the 2nd support part 12 and the elastic plug body 2 contact and weld in the said protrusion part 36. FIG. Moreover, it is preferable that each projecting portion 31 is provided so as to be positioned in a gap between the adjacent annular walls 14. Thereby, a pressing force can be applied equally to the plurality of annular walls 14 and the elastic plug body 2. However, the number of the protruding portions 31 is not particularly limited, and at least one may be provided.

  The thickness of the protruding portion 31 is not particularly limited, and can be set as appropriate according to the size of the medical cap 10 and the pressing force applied to the elastic plug 2 and the annular wall 14.

  Further, the height of the protruding portion 31 is formed by the molten resin flowing into the gap between the annular wall 14 and the lower mold described later. It becomes the same as the depth.

  Further, the second support portion 12 is preferably provided with an annular support portion 34 for supporting the peripheral portion 25 on the liquid contact surface 21 side of the elastic plug body 2. Thereby, it can prevent that the elastic plug body 2 is extruded to the liquid-contacting surface 21 side. The thickness and the inner diameter of the annular support portion 34 are not particularly limited as long as they can sufficiently support the elastic plug body 2. However, if the inner diameter is too small, the needle sticking area when needle sticking to the elastic plug body 2 becomes too small, which is not preferable. The annular support portion 34 is preferably provided in an annular shape on the inner side surface of the protruding portion 31, but the present invention is not limited to this. For example, a structure in which a plurality of support portions are provided at a predetermined interval may be used. In this case, the separation distance between the adjacent support portions is not particularly limited as long as the elastic plug body 2 is supported to such an extent that the elastic plug body 2 is not pushed out from the outer frame body 1. Note that the annular support portion 34 may be provided with an annular ridge that enables fitting with the elastic plug body 2. Thereby, position shift and dropping of the elastic plug body 2 can be further prevented.

  The thickness of the projecting portion 31 is not particularly limited, but is appropriately set according to the size of the gap between the annular wall 14 and the lower mold, the compression characteristics of the elastic plug body 2, and the like. Specifically, the thickness of the protruding portion 31 is preferably in the range of 0.3 mm to 6 mm, and more preferably in the range of 0.5 mm to 3 mm.

  The height of the outer wall 32 is preferably higher than that of the annular wall 14. This is because if the height is lower than the annular wall 14, the annular wall 14 may obstruct the attachment when the medical cap 10 is attached to the mouth of the medicine container. Specifically, the height of the outer wall 32 is preferably within a range of 4 mm to 20 mm, and more preferably within a range of 5 mm to 18 mm. The thickness of the outer wall 32 is not particularly limited, but it is preferably thicker than the annular wall 14 from the viewpoint of maintaining the shape of the second support portion 12. Specifically, the thickness of the outer wall 32 is preferably in the range of 0.3 mm to 3 mm, and more preferably in the range of 0.4 mm to 2 mm.

  As a material constituting the first support portion 11 and the second support portion 12 (that is, the outer frame body 1), it is sufficient to use a synthetic resin that has established safety for medical use. 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 the present invention is not limited to these.

  The elastic plug 2 is preferably accommodated inside the annular wall 14 in the first support portion 11 with the liquid contact surface 21 on the upper side and the needle piercing surface 22 on the lower side. Here, the said liquid contact surface 21 means the surface which a chemical | medical solution etc. contact. Further, the needle puncture surface 22 means a surface on which needle puncture is performed with an injection needle when the medical cap 10 according to the present embodiment is attached to a drug container and a drug solution or the like is taken out.

  The elastic plug body 2 is in contact with the projecting portion 31 of the second support portion 12 in the gap between the plurality of annular walls 14 and welded at this contact portion. The term “welding” as used herein means that the surface of the elastic plug body 2 in contact with the second support portion 12 is melted by the heat of the molten resin injected when the second support portion 12 is molded by injection molding or the like. It means that the elastic plug body 2 and the projecting portion 31 are joined at the contact portion after the support portion 12 is molded.

  Moreover, although the whole shape of the said elastic plug body 2 is not specifically limited, For example, the cylindrical thing shown in FIG. 1 is preferable. Further, an annular groove capable of fitting with the annular protrusion may be provided on the needle piercing surface 22 side of the elastic plug body 2.

  The characteristic of the elastic plug body 2 is not particularly limited as long as it has a hardness that allows a medical injection needle or the like to pass therethrough. 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 hardness of the elastic plug body 2 is preferably A5 to A50, more preferably A10 to A45, as measured by JIS K6253 method.

  Examples of the material used for the elastic plug 2 include rubber and thermoplastic elastomer. 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 diameter of the elastic plug body 2 is not particularly limited. In the case where the elastic plug body 2 is welded to the annular wall 14, the diameter of the elastic plug body 2 is the same as the inner diameter of the annular wall 14. Further, in the case where the elastic plug 2 is not welded to the annular wall 14, it is sufficient that the elastic stopper 2 can be accommodated inside the annular wall 14 in the first support portion 11. However, if the diameter of the elastic plug body 2 is too small, when the elastic plug body 2 is accommodated in the first support portion 11 without being welded, the annular wall 14 is deformed in a direction in which the diameter decreases. However, it is difficult to make the elastic plug 2 closely contact with the side peripheral surface 23, which is not preferable. Specifically, the diameter of the elastic plug body 2 is set within a range of 10 mm to 30 mm. Furthermore, it is preferable that the diameter of the elastic plug 2 is set to be smaller in the range of 0.03 mm to 1 mm than the inner diameter of the annular wall 14 of the first support portion 11. Thereby, the ease of insertion of the elastic plug 2 inside the annular wall 14 is ensured. Furthermore, the thickness of the elastic plug 2 is not particularly limited as long as it is the same as or smaller than the height of the annular wall 14, but is preferably 2.5 mm to 12 mm, more preferably 3 mm to 9 mm. Moreover, when providing an annular groove in the needle stab surface 22 side, the depth is not specifically limited, Preferably it is 0.2 mm-2 mm, More preferably, it exists in the range of 0.3 mm-1.5 mm.

  The method for producing the elastic plug body 2 is not particularly limited, and for example, it can be produced by compression molding or injection molding performed while crushing the thermoplastic elastomer.

  In the present embodiment, a medical cap having a configuration in which the second support portion 12 includes a diaphragm portion may be used. The diaphragm portion is for covering the liquid contact surface 21 of the elastic plug body 2. The thermoplastic elastomer material constituting the elastic plug body 2 is an extremely hygienic material as compared with the rubber material, but depending on the chemical solution to be used, there are some which are not preferable in contact with the elastic plug body 2. Therefore, by providing the diaphragm portion, the portion where the chemical solution contacts can be made of a material having the same or similar property as the container.

  Examples of the diaphragm part include a laminate film fused to the elastic plug body 2, a film joined at the time of forming the second support part 12 by an insert, a film part integrally formed with the second support part 12, and the like. The laminate film is not particularly limited, and one that can be fused with the second support portion 12 made of the synthetic resin is used. Specifically, for example, a plastic film mainly composed of fluororesin, polyethylene, polypropylene, polyester, ethylene vinyl acetate resin, or a mixture thereof can be used. Although the thickness of a diaphragm part is not specifically limited, The inside of the range of 0.01 mm-1 mm is preferable, and the inside of the range of 0.03 mm-0.5 mm is more preferable. By making the thickness of the diaphragm part 1 mm or less, penetration at the time of needle stick is enabled. On the other hand, by setting the thickness of the diaphragm part to 0.01 mm or more, the diaphragm part can be prevented from being broken.

  In the medical cap 10 according to the present embodiment, the protrusion is provided so that pressure is applied directly from the protrusion 31 to the elastic plug 2 in the center direction and indirectly through the annular wall 14. The 2nd support part 12 provided with the part 31 is shape | molded. The pressure applied to the elastic plug 2 usually depends on the direction of the needle puncture surface at the central axis of the elastic plug 2, although it depends on the shape and thickness of the annular wall 14 and the protruding portion 31. . Moreover, the pressure applied to the elastic plug body 2 becomes smaller toward the needle piercing surface 22 side. Due to this action, the restoring force of the elastic plug body 2 itself acts in the direction of the side peripheral surface of the elastic plug body 2 and tries to expand. As a result, even if the elastic plug body 2 and the annular wall 14 are not welded, the annular wall 14 can be improved. As a result, when needle sticking is performed on the needle sticking surface 22 of the elastic plug body 2, it is possible to prevent the occurrence of liquid leakage and to improve the holding force and restoring force against needle removal. Further, when the needle is pulled out, the elastic plug 2 receives a force pushed from the annular wall 14 toward the needle piercing surface in the central axis, so that the hole generated by the needle can be closed. Thereby, it can be excellent in resealability after needle removal. In addition, the liquid-contacting surface 21 side and the needle piercing surface 22 side of the elastic plug body 2 may each have a shape in which the central portion slightly protrudes in a convex shape. In the present embodiment, the medical cap has a circular cross section as an example. However, the present invention is not limited to this, and the operational effects of the present invention, such as an elliptical one, are achieved. If it is a shape, it will not specifically limit.

(Manufacturing method of medical cap)
Next, a method for manufacturing a medical cap according to the present embodiment will be described. 5-7 is a cross-sectional schematic diagram for demonstrating the manufacturing method of a medical cap. FIG. 8 is an explanatory view of a second upper mold used when molding the second support part in the medical cap, and FIG. 8A is a plan view when viewed from the inside. (B) is the AA arrow directional cross-sectional view in the figure (a). FIG. 9 is a schematic diagram showing the positional relationship between the pressing portion and the annular wall 14 in the second upper mold during molding of the second support portion.

  The manufacturing method of the medical cap includes a step of producing a first support portion 11 in which the elastic plug body 2 is accommodated inside, and a first support portion 11 in which the elastic plug body 2 is accommodated inside is placed in a mold, The mold is closed with the annular wall 14 pressed in the center direction to form a molding cavity for the second support part 12, and the second support part is injected by injecting molten resin into the cavity. 12 is formed.

  First, as shown in FIG. 5 (a), the first support portion 11 in which the elastic plug 2 is accommodated is manufactured by using a first upper mold 41 and a common lower mold 42. The part 11 is injection molded. The first upper mold 41 is a core (convex mold), and the common lower mold 42 is a cavity (concave mold). The first upper mold 41 and the common lower mold 42 have a structure in which a cavity capable of forming the first support portion 11 is formed when the mold is closed. Further, the first upper mold 41 is provided with a housing portion 43 capable of housing the elastic plug body 2 prepared in advance.

  As shown in FIGS. 5 (b) and 5 (c), the first support portion 11 is molded with the first upper die 41 and the common lower die in a state where the elastic plug 2 is accommodated in the accommodating portion 43. Thereafter, the mold 42 is closed, and then, as shown in FIG. 5D, molten resin 51 obtained by melting a resin as a constituent material of the first support portion 11 is injected into the cavity. Further, in the present embodiment, the elastic plug body 2 is accommodated so that the needle stick surface 22 faces the common lower mold 42 side. The injection pressure is not particularly limited, and can be set as necessary. The injected molten resin is cooled in a closed state. The cooling time is not particularly limited, and can be set as necessary. After the mold opening, as shown in FIGS. 6 (a) and 7 (a), the first support portion 11 in which a plurality of annular walls 14 are erected on the annular frame portion 13 is formed. The elastic plug 2 is welded on the contact surface with the annular wall 14.

  The elastic plug body 2 may be stored after the first support portion 11 is molded. In this case, after producing the 1st support part 11 and the elastic plug body 2, respectively, the process of accommodating the elastic plug body 2 inside the annular wall 14 in the 1st support part 11 is added. In this case, the elastic plug 2 and the annular wall 14 are not welded on the contact surface.

  Next, the 2nd support part 12 is shape | molded (refer FIG.6 (b)-6 (e)). The second support portion 12 is formed using a second upper mold 44 shown in FIG. The second upper mold 44 is a core (convex type). The second upper mold 44 and the common lower mold 42 have a structure in which a cavity capable of molding the second support portion 12 is formed when the mold is closed. The second upper mold 44 is provided with a plurality of protruding pressing portions 45 that can press the top of the annular wall 14 toward the center of the elastic plug 2. Each pressing portion 45 is annularly arranged at a position corresponding to the annular wall 14.

  The height H of the pressing portion 45 is not particularly limited, and can be set as necessary (see FIG. 8B). However, it is preferable that the lower limit of the height H is not less than the level at which the annular wall 14 can be pressed when the mold is closed. The upper limit of the height H is preferably such that the pressing portion 45 does not reach the annular frame portion 13 of the first support portion 11. The height H of the pressing portion 45 means the distance from the base portion 47 to the tip of the pressing portion 45.

  The width w of the pressing portion 45 is preferably at least smaller than the width W of the annular wall 14 (see FIG. 9). Thereby, welding of the protrusion part 31 and the annular wall 14 which are shape | molded is enabled. Further, as can be seen from the figure, the pressing portion 45 is preferably arranged so as to press the substantially central portion against the annular wall 14.

  The shape of the pressing portion 45 is not particularly limited, but it is preferable that the inner pressing surface 49 is tapered and tapered toward the tip. With such a pressing surface 49, when the second upper mold 44 and the common lower mold 42 are closed, the elastic plug body 2 is gradually pressed in the center direction through the annular wall 14. Pressure can be applied. Moreover, since the part which presses the annular wall 14 is a surface where the pressing surface 49 inside the pressing portion 45 is inclined in a curved shape, the second upper mold 44 and the common lower mold 42 can be smoothly closed. Can do.

  Further, an annular ring portion 46 is further provided inside the pressing portion 45 arranged in an annular shape of the second upper mold 44 (see FIG. 8). The ring portion 46 presses the peripheral edge 25 on the liquid contact surface 21 side of the elastic plug 2 when the second upper die 44 and the common lower die 42 are closed. Thereby, when the molten resin is filled in the mold, the molten resin can be prevented from flowing into the gap between the liquid contact surface 21 side of the elastic plug 2 and the second upper mold 44.

  The height h of the ring portion 46 is not particularly limited, but when the second upper mold 44 and the common lower mold 42 are closed, the swelling of the pressed elastic stopper 2 on the liquid contact surface 21 side is constant. Anything can be accommodated. The diameter of the ring portion 46 is preferably smaller than the diameter of the liquid contact surface 21 of the elastic plug body 2, whereby the ring portion 46 can be brought into contact with the peripheral portion 25 of the liquid contact surface 21.

  Here, the detail of the formation process of the 2nd support part 12 is shown to Fig.7 (a)-7 (c). As shown in FIG. 7B, when the second upper mold 44 and the common lower mold 42 are closed, the pressing portion 45 of the second upper mold 44 presses the annular wall 14. As a result, in a state where the second upper mold 44 and the common lower mold 42 are closed, the elastic plug body 2 receives pressure from the pressing portion 45 through the annular wall 14 in the direction toward the center thereof. ing. A cavity that enables the second support portion 12 to be formed is also formed.

Next, as shown in FIG. 7 (c), a molten resin 52, which is a constituent material of the second support portion 12 and is melted, is injected into the cavity from the resin injection port 48. The injection pressure is not particularly limited, and can be set as necessary. The injected molten resin 52 is cooled in a closed state. The cooling time is not particularly limited, and can be set as necessary. After the mold opening, as shown in FIG. 6 (e), the second support portion 12 including the projecting portion 31 is formed. The protruding portion 31 of the second support portion 12 is welded to the elastic plug 2 in the gap between the adjacent annular walls 14.
As described above, the medical cap 10 according to the present embodiment is obtained.

  In the medical cap 10 obtained by the above-described manufacturing method, the elastic plug body 2 is provided on the elastic plug body 2 by the annular wall 14 and the protruding portion 31 in the direction indicated by the arrow in FIG. The pressing force (caulking force) is working. Due to the action of this pressing force, the restoring force of the elastic plug body 2 itself acts in the direction of the side peripheral surface 23 of the elastic plug body 2 and attempts to expand. As a result, the sealing performance with the annular wall 14 is improved. As a result, the holding force against the needle removal and the restoring force are improved, and the resealability after needle removal can be improved.

  In the present embodiment, the embodiment in which the annular ring portion 46 is provided as the second upper mold is illustrated, but the present invention is not limited to this. For example, as shown in FIG. 10, instead of the ring portion 46, a second upper mold 64 provided with a concave portion 63 recessed in an arc shape may be used. FIG. 10 is an explanatory view of the second upper mold 64 used when molding the second support part in the medical cap, and FIG. 10 (a) is a plan view when viewed from the inside. (B) is the BB arrow sectional drawing of the figure (a). The depth of the concave portion 63 is not particularly limited, but can be accommodated to accommodate a bulge on the liquid contact surface 21 side of the pressed elastic stopper 2 when the second upper die 64 and the common lower die 42 are closed. It is preferable that the space is formed. The diameter of the concave portion 63 is preferably smaller than the diameter of the liquid contact surface 21 of the elastic plug body 2, so that the peripheral edge portion of the concave portion 63 can be brought into contact with the peripheral edge portion of the liquid contact surface 21. It is possible to prevent the resin from flowing into the gap between the liquid contact surface 21 of the elastic plug body 2 and the second upper mold 64.

DESCRIPTION OF SYMBOLS 1 Outer frame body 2 Elastic plug body 10, 10 'Medical cap 11 1st support part 12 2nd support part 13 Annular frame part 14 Annular wall 15 Placement part 17 Flange part 21 Liquid contact surface 22 Needle stick surface 23 Side circumference Surface 31 Projection portion 32 Outer wall 34 Annular support portion 36 Projection portion 41 First upper die 42 Common lower die 43 Housing portion 44, 64 Second upper die 45 Pressing portion 46 Ring portion 47 Base portion 48 Resin note Inlet 49 Press surface 51, 52 Molten resin 63 Recess

Claims (7)

A medical cap having an elastic plug and an outer frame that accommodates the elastic plug inside,
The outer frame is
An annular frame, and a first support provided at least with a plurality of annular walls provided standing on the annular frame at regular intervals and surrounding and accommodating the elastic plug;
An outer wall surrounding the annular wall, and a second support portion provided with a plurality of protruding portions protruding from the inner side surface of the outer wall in a state of being separated from each other ,
The projecting portion is welded to a contact surface of the annular wall in a state where the annular wall and the elastic plug body are pressed, and is also in contact with the elastic plug body at a plurality of gaps between the annular walls. And welded
The elastic plug is a medical cap to which pressure is applied from the annular wall and the protruding portion.   The medical cap according to claim 1, wherein the elastic plug and the annular wall are welded to each other at a contact surface. The annular walls are arranged in a ring shape in a state of being separated from each other,
The medical cap according to claim 1 or 2, wherein a protruding portion is provided on the pressing surface of the protruding portion so as to be positioned in a gap between the plurality of annular walls . A method for producing the medical cap according to claim 1 or 2,
Producing the first support part in which the elastic plug is housed inside the annular wall;
An upper mold provided with a pressing portion for placing the first support portion in which the elastic plug body is accommodated inside the annular wall in a lower mold and pressing the annular wall in the first support portion is used. And closing the mold in a state of pressing the annular wall in the center direction to form a molding cavity of the second support part;
A step of injecting molten resin into the cavity and molding the second support portion including an outer wall surrounding the first support portion and a projecting portion projecting from the inner surface of the outer wall. Manufacturing method. The medical cap according to claim 4 , wherein the upper mold is provided with a ring portion that presses the peripheral edge of the elastic plug when the upper mold and the lower mold are closed. Manufacturing method. Manufacturing process of the first support portion which is housed inside the elastic plug member said annular wall, the Rukoto be molded the first support portion in a state in which the elastic stopper is placed inside the mold, The method for producing a medical cap according to claim 4 or 5 , which is a step of producing a first support part in which the elastic plug and the annular wall are welded to each other at a contact surface. The manufacturing process of the first support part in which the elastic plug body is accommodated inside the annular wall is formed by accommodating the elastic plug body inside the annular wall after the molding of the first support part.
  The method for producing a medical cap according to claim 4 or 5, which is a step of producing a first support portion in which the elastic plug and the annular wall are not welded at a contact surface.

Images