JP5924767B2 - 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 problem, Patent Document 2 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.

  Patent Document 3 below discloses a method for manufacturing a composite material molded product in which a hard plastic is melt-injected and pressed so as to surround an outer edge of a thermoplastic elastomer molded product. According to the manufacturing method, it is described that the thermoplastic elastomer molded product is fitted in a state in which it is subjected to compressive stress from a hard plastic, thereby improving airtightness and liquid tightness.

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

JP-A-2005-118185 JP-A-8-317961 JP 2000-167865 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 a support that holds the elastic plug in the elastic plug and the support. Providing a medical cap excellent in sealing performance such as prevention of voids due to misalignment, no liquid leakage at the time of needle sticking, and excellent retention and restoring force against needle removal, and a method for manufacturing the same It is in.

  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 that includes an elastic plug and a support that holds the elastic plug inside, in order to solve the above-described problems. An internal wall that surrounds and accommodates the elastic plug and an external wall that surrounds the internal wall, and an internal plug having an annular wall is press-fitted into the gap between the internal wall and the external wall. The elastic plug body is welded at a contact surface with the support and is not welded to the inner plug, and the annular wall is press-fitted into the elastic plug body. Thus, pressure is applied from the inner wall.

  According to the above configuration, the support is welded at the contact surface with the elastic plug. 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 support. Furthermore, the occurrence of liquid leakage can be prevented and sealing performance can be ensured. Further, since the annular wall of the inner plug is press-fitted into the gap between the outer wall and the inner wall of the support body, it has excellent holding force and restoring force against needle removal, and also has a resealability after needle removal. Can be improved. In the above configuration, since the annular wall of the inner plug is press-fitted without contacting the elastic plug, the elastic plug is not deformed by friction during press-fitting. As a result, the displacement of the elastic plug body can be prevented. The “press fit” means that the annular wall of the inner plug is forcibly inserted into the gap between the outer wall and the inner wall, and the annular wall is fitted while applying pressure to the outer wall and the inner wall.

  In the above-described configuration, it is preferable that at least one notch is provided on the inner wall of the support. With this configuration, the inner wall can be deformed in a direction in which the diameter is reduced by press-fitting the annular wall of the inner plug into the gap between the inner wall and the outer wall of the support. Thereby, it becomes possible to more effectively transmit the pressure due to the press-fitting of the annular wall to the elastic plug body through the inner wall, and to further improve the adhesion between the inner wall and the elastic plug body. it can.

  In the above configuration, an annular groove for holding the press-fitted inner plug is provided at the top of the inner surface of the outer wall, and the inner plug has a peripheral edge of the bottom of the annular wall. It is preferable that an annular ridge portion that is fitted in the annular groove and engages the inner plug is provided in the portion. For the inner plug that has been press-fitted, a force is exerted to push it to the outside of the support, but with the above structure, the annular protrusion provided on the inner plug and the outer wall are provided. The inner plug is locked by fitting the annular groove. As a result, the inner plug can be prevented from being pushed out of the support.

  In the above configuration, the inner plug is preferably provided at the tip of a port used for an infusion bag.

  In order to solve the above problems, a method for producing a medical cap according to the present invention is a method for producing a medical cap having an elastic plug and a support that holds the elastic plug inside. Provided with the elastic plug body in the mold, and by injecting molten resin into the cavity in the mold, and comprising an inner wall that surrounds and accommodates the elastic plug body, and an outer wall that surrounds the inner wall, In addition, the step of producing the support body welded to the elastic plug body on the contact surface, and the production of an inner plug provided with an annular wall capable of being press-fitted into the gap between the inner wall and the outer wall of the support body And a step of press-fitting the annular wall of the inner plug into the gap between the inner wall and the outer wall of the support.

  In the above method, the support body is molded in a state in which the elastic plug body prepared in advance is provided in the mold, so that the elastic plug body is welded to the contact surface and integrally molded. A support is prepared. Furthermore, the inner plug provided with the annular wall prepared separately is combined with the support body formed integrally with the elastic plug body. The combination is performed by forcibly inserting (pressing) the annular wall of the inner plug into the gap between the outer wall and the inner wall of the support. By this press-fitting, the annular wall of the inner plug applies pressure to the outer wall and the inner wall of the support, and for example, the inner wall can be deformed in a direction in which the diameter decreases. As a result, pressure can be applied to the elastic plug housed inside the inner wall via the inner wall, and it has excellent holding force and restoring force against needle removal, and reseals after needle removal. A medical cap with good properties can be obtained.

  Further, in the press-fitting of the inner plug, since the annular wall of the inner plug does not contact the elastic plug body, the elastic plug body is not deformed by friction during the press-fitting. As a result, the displacement of the elastic plug body can be prevented, and the production efficiency can be improved.

  In addition, since the medical cap manufactured by the above method has a structure in which the support is welded at the contact surface with the elastic plug, for example, when the needle is inserted into the elastic plug, the elastic plug and the support It is possible to prevent a gap from being generated due to the displacement. Furthermore, the occurrence of liquid leakage can be prevented and sealing performance can be ensured.

  The medical cap of the present invention includes an elastic plug and a support that holds the elastic plug inside. The support surrounds and houses the elastic plug, and the internal wall. And an inner plug having an annular wall is provided by press-fitting the annular wall into a gap between the inner wall and the outer wall. In addition, since the elastic plug has a structure welded to the contact surface with the support, it is possible to prevent a gap from being generated due to the displacement of the elastic plug even if the elastic plug is pierced with needle. it can. As a result, occurrence of liquid leakage and the like can be prevented, and excellent sealing performance can be achieved. In addition, since pressure is applied to the elastic plug from the inner wall, it has excellent holding force and restoring force against needle removal, and also has good resealability after needle removal.

  Further, since the annular wall of the inner plug is press-fitted into the gap between the inner wall and the outer wall, it is not brought into contact with the elastic plug body. Therefore, unnecessary friction and resistance are not given to the elastic plug body, and deformation of the elastic plug body and displacement of the elastic plug body can be prevented.

It is a section perspective view showing the medical cap concerning one embodiment of the present invention. It is a cross-sectional schematic diagram for explaining a support provided with an elastic plug in the medical cap, wherein FIG. (A) represents a state in which the elastic plug is integrally provided inside the support, FIG. 5B shows only the support member without the elastic plug member. It is a cross-sectional schematic diagram for demonstrating the inner plug in the said medical cap. It is a cross-sectional schematic diagram for demonstrating the other medical cap of this invention, Comprising: The aspect used for the bottle for infusion is represented. It is a cross-sectional perspective view showing the medical cap which concerns on other embodiment of this invention. It is a cross-sectional schematic diagram for explaining a support provided with an elastic plug in the medical cap, wherein FIG. (A) represents a state in which the elastic plug is integrally provided inside the support, FIG. 5B shows only the support member without the elastic plug member. It is a cross-sectional schematic diagram for demonstrating the inner plug in the said medical cap.

(Embodiment 1)
The medical cap according to the first 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 a support provided with an elastic plug in the medical cap. FIG. 2A shows an elastic plug integrally provided in the support. FIG. 5B shows only the support member without the elastic plug body. FIG. 3 is a schematic cross-sectional view for explaining an inner plug in the medical cap.

As shown in FIG. 1, the medical cap 10 according to the present embodiment includes at least a support body 1, an elastic plug body 2, and an inner plug 3.
The support 1 can hold the elastic plug 2 inside thereof. Specifically, the support 1 surrounds and houses the elastic plug 2 and an external wall 11 surrounding the internal wall 12. At least integrally (see FIG. 2A). In addition, the inner wall 12 is welded to the elastic plug 2 at the contact surface, whereby the elastic plug 2 and the support 1 are integrally formed. Here, the “welding” is a result of melting the surface of the elastic plug 2 in contact with the heat of the molten resin injected when the support 1 is molded by injection molding or the like, as described below. It means that the support body 1 and the elastic plug body 2 are in a bonded state at the contact surface after the support body 1 is molded.

  The internal wall 12 is preferably provided with a notch portion 14 as shown in FIG. Thereby, it becomes easy to deform the inner wall 12 in the direction in which the diameter decreases. It is sufficient that the cutout portion 14 is provided at least at one place on the inner wall 12. However, when a plurality of cutout portions 14 are provided, it is preferable to arrange the cutout portions 14 so as to form a pair on a diagonal line. Thereby, it is possible to uniformly deform the inner wall 12 in the same direction, and it is possible to prevent the pressure applied to the elastic plug body 2 from being biased. However, the present invention may be an annular inner wall in which the notch portion 14 is not provided. In this case, the inner wall 12 is preferably thinner than the outer wall 11. This facilitates the deformation of the inner wall in the direction in which the diameter decreases. Specifically, the thickness of the inner wall 12 in the case where the notch 14 is provided is preferably within a range of 0.1 mm to 2.5 mm, and more preferably within a range of 0.2 mm to 1 mm. Further, the thickness of the inner wall 12 when the notch 14 is not provided is preferably within a range of 0.1 mm to 2 mm, and more preferably within a range of 0.2 mm to 0.8 mm.

  Moreover, the depth of the notch of the notch 14 is not particularly limited, and may reach the bottom of the inner wall 12 as shown in FIG. Moreover, you may change to arbitrary depth corresponding to the thickness of the inner wall 12 suitably. Further, the notch shape of the notch portion 14 is a rectangular shape in FIG. 2B, but is not particularly limited as long as the inner wall 12 can be deformed in a direction in which the diameter decreases. Is not to be done.

  The height of the inner wall 12 is not particularly limited, but when the elastic plug body 2 is accommodated therein as shown in FIG. 2A, it is preferably the same as or higher than the height of the elastic plug body 2. . Thereby, the inner wall 12 can be accommodated so as to cover the entire side peripheral surface 23 of the elastic plug body 2, and pressure can be effectively applied to the elastic plug body 2. Specifically, the height of the inner wall 12 is 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 inner wall 12 is not particularly limited. For example, as shown in FIG. 2B, the inner wall 12 may have a shape in which the cross-sectional shape tapers toward the top. As a result, the gap with the external wall 11 can be widened at the top and narrowed toward the bottom. As a result, it is possible to facilitate the press-fitting of the annular wall 31 of the inner plug 3 and to ensure the fitting into the gap. On the other hand, the thickness of the bottom of the inner wall 12 may be equal to or thinner than the top. As a result, the pressure applied to the elastic plug 2 can be increased even at the bottom of the inner wall 12. In addition, the thickness of the inner wall 12 shall be suitably set within the aforementioned numerical range.

  A mounting portion 13 is provided at the bottom of the inner wall 12 so that the elastic plug body 2 can be mounted in a welded state. Further, the mounting portion 13 is provided so as to project from the inner wall 12 in the center direction. Thereby, the peripheral part of the needle piercing surface 22 of the elastic stopper 2 can be supported. As a result, when the annular wall 31 of the inner plug 3 is press-fitted into the gap between the outer wall 11 and the inner wall 12, the elastic plug body 2 can be prevented from being pushed out of the support body 1. Furthermore, the mounting portion 13 may be provided with an annular ridge that enables fitting with the elastic plug 2. Thereby, it is possible to further prevent the elastic plug 2 from being pushed out of the support 1. Moreover, in this Embodiment, although the case where the mounting part 13 was cyclic | annular was illustrated, this 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 such an extent that it is not pushed out from the support body 1 when the annular wall of the inner plug 3 is press-fitted. In the present embodiment, it is also possible to adopt a structure in which the mounting portion 13 is omitted from the support 1. The elastic plug body 2 is in a welded state with the inner wall 12, and even if the annular wall 31 of the inner plug 3 is press-fitted into the gap between the outer wall 11 and the inner wall 12, the elastic plug body 2 is displaced or dropped. This is because it can be prevented.

  You may provide the latching | locking part for maintaining the inner stopper 3 after press-fit in the state on the top part of the said external wall 11. FIG. Thereby, it is possible to prevent the inner plug 3 from being pushed out of the support 1. As such a locking portion, a ring-shaped one projecting in the direction toward the inside of the support 1 at the top of the outer wall 11, or in the direction toward the inside at the top of the outer wall 11. Examples include one or more protruding protrusions arranged at predetermined intervals.

  Furthermore, as shown in FIGS. 2 (a) and 2 (b), the top of the outer wall 11 can be easily joined by ultrasonic welding or the like to the mouth of a drug container such as an infusion container, a blood collection tube, or a vial. In order to achieve this, a flange portion 17 projecting outside the outer wall 11 is provided.

  The height of the outer wall 11 is preferably higher than the inner wall 12. This is because when it is lower than the inner wall 12, the inner wall 12 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 11 is preferably in the range of 4 mm to 20 mm, and more preferably in the range of 5 mm to 18 mm. Although the thickness of the outer wall 11 is not particularly limited, it is preferably thicker than the inner wall 12 from the viewpoint of maintaining the shape of the support 1 even when the inner plug 3 is press-fitted. Specifically, the thickness of the outer wall 11 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.

  The distance between the outer wall 11 and the inner wall 12 can be appropriately set according to the shape of the annular wall 31 of the inner plug 3 to be described later. Specifically, it is preferably in the range of 0.3 mm to 5 mm, and more preferably in the range of 0.5 mm to 2 mm. Further, the gap distance may be narrowed toward the bottom of the outer wall 11 and the inner wall 12 within the numerical range. Thereby, the press-fitting of the annular wall 31 can be facilitated.

  The material constituting the support 1 may be any 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 are not limited thereto.

  The elastic plug 2 is preferably accommodated in the inner wall 12 of the support 1 with the liquid contact surface 21 facing upward and the needle piercing surface 22 facing downward. Further, as described above, the elastic plug body 2 is in contact with and welded to the inner wall 12 on the side peripheral surface 23 thereof. Further, the peripheral portion on the needle puncture surface 22 side is also in contact with and welded to the placement portion 13. Therefore, the elastic plug 2 has a structure integrated with the support 1. The liquid contact surface 21 refers to a surface in contact with a chemical solution or the like. 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.

  Further, the overall shape of the elastic plug 2 is not particularly limited, but for example, a cylindrical shape shown in FIG. The diameter of the elastic plug body 2 is not particularly limited, and can be set as necessary. The shape of the elastic plug body 2 is not limited to the form shown in FIG. For example, when an annular ridge is provided on the mounting portion 13 of the support 1, an elastic stopper provided with an annular groove on the needle piercing surface 22 side that can be fitted to the ridge. Good. Further, both the needle stick surface and the liquid contact surface may be flat elastic plugs. Furthermore, an elastic stopper provided with at least one stepped step portion on the needle puncture surface side may be used to prevent the dropout.

  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.

  Moreover, the diameter of the elastic plug body 2 is not specifically limited, Usually, it sets within the range of 10 mm-30 mm. Further, 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 inner wall 12, but is preferably 2.5 mm to 12 mm, more preferably 3 mm to 9 mm. Moreover, when providing the said annular groove in the needle puncture surface 22 side, the depth is although it does not specifically limit, 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.

  As shown in FIG. 3, the inner plug 3 may have at least an annular wall 31 for press-fitting into the gap between the outer wall 11 and the inner wall 12 in the support 1. The inner plug 3 shown in the figure has a configuration provided at a port 41 used for a bag for infusion or a container such as a bottle or the tip of the port portion. Further, the port 41 and the inner plug 3 may be formed by combining mutually independent members, or may be integrally formed.

  Further, the height of the annular wall 31 in the inner plug 3 is preferably equal to or smaller than the depth of the gap between the outer wall 11 and the inner wall 12. When the height of the annular wall 31 is larger than the depth of the gap between the outer wall 11 and the inner wall 12, the inner plug 3 and the flange portion 17 of the support 1 are inserted into the gap between the outer wall 11 and the inner wall 12. It becomes difficult to make the bonding portion 35 (in the second embodiment described later, the annular groove 62 and the protrusion 72) closely contact each other. Specifically, the height of the annular wall 31 is preferably in the range of 2.5 mm to 14 mm, and more preferably in the range of 3 mm to 11 mm. In addition, the height of the annular wall 31 means a vertical height with respect to a horizontal line in contact with the top of the inner wall 12 in a state where the flange portion 17 and the joint portion 35 are in close contact with each other.

  In addition, since the elastic plug body 2 according to the present embodiment is welded on the contact surface of the inner wall 12 and the mounting portion 13, for example, the elastic plug body 2 does not fall off during needle stick or the like. However, the inner plug 3 may be provided with a support portion for supporting the elastic plug body 2 from the liquid contact surface 21 side. Thereby, it is possible to prevent the elastic plug body 2 from being pushed out toward the liquid contact surface 21 due to the press-fitting of the inner plug 3. The support portion is preferably provided in an annular shape on the inner surface of the annular wall 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 adjacent support portions is not particularly limited as long as the elastic plug body 2 can be supported to the extent that it is not pushed out from the support body 1 when the annular wall of the inner plug 3 is press-fitted. When the support portion is provided in an annular shape, the thickness and the inner diameter thereof are not particularly limited as long as the elastic plug body 2 can be sufficiently supported. However, if the inner diameter is too small (that is, if the support portion is too large), the needle sticking area when needle sticking to the elastic plug 2 is reduced, which is not preferable. Note that the support portion may be provided with an annular protrusion that allows the elastic plug body 2 to be fitted. Thereby, the elastic plug body 2 can be reliably supported, and positional deviation and dropout can be further prevented.

  Furthermore, the thickness of the annular wall 31 is not particularly limited, but is appropriately set according to the size of the gap between the outer wall 11 and the inner wall 12, the compression characteristics of the elastic plug 2, and the like. Specifically, the thickness of the annular wall 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 shape of the annular wall 31 is not particularly limited. For example, as shown in FIG. 3, the annular wall 31 may have a shape that tapers toward the top. As a result, the annular wall 31 can be easily pressed into the gap between the outer wall 11 and the inner wall 12. Further, the thickness may be uniform from the top to the bottom. In any case, the thickness of the annular wall 31 is set within the numerical range.

  In the case where a locking portion for maintaining the inner plug 3 after press-fitting is maintained at the top of the outer wall 11, the engagement portion is provided on the peripheral edge of the bottom of the annular wall 31 in the inner plug 3. It is preferable to provide an annular step portion that can be locked with the stop portion. Thereby, when the inner plug 3 is mounted inside the support 1, the inner plug 3 can be prevented from being pushed out of the support 1.

  The constituent material used for the inner plug 3 is not particularly limited. For example, the same material as that used for the support 1 can be used.

  By press-fitting the inner plug 3 into the gap between the outer wall 11 and the inner wall 12 in the support 1, the inner wall 12 can be deformed in a direction in which the diameter decreases. As a result, the elastic plug body 2 housed inside the inner wall 12 receives pressure from the inner wall 12. The pressure applied to the elastic plug 2 depends on the shape and thickness of the notch 14 provided on the inner wall 12, but is usually directed toward the needle puncture surface on the central axis of the elastic plug 2. Works. Moreover, the pressure applied to the elastic plug body 2 becomes smaller toward the needle piercing surface 22 side. As a result of the 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 attempts to expand, so that the adhesion with the inner wall 12 is improved. Thereby, when needle puncture is performed on the needle puncture surface 22 of the elastic plug body 2, the occurrence of liquid leakage can be prevented, and the holding force and restoring force against needle removal can be improved. Furthermore, 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.

  Further, the annular wall 31 of the inner plug 3 is press-fitted into the gap between the outer wall 11 and the inner wall 12. It is not performed for the gap between the outer wall 11 and the elastic plug 2. Therefore, the annular wall 31 does not cause deformation due to friction to the elastic plug 2 when the inner plug 3 is press-fitted. Thereby, the deformation | transformation of the elastic plug body 2 at the time of the press injection of the inner plug 3 can be prevented, and the position shift of the said elastic plug body 2 can be prevented.

  Next, a method for manufacturing a medical cap according to the present embodiment will be described. The medical cap manufacturing method includes an inner wall 12 that surrounds and accommodates the elastic plug 2 by providing the elastic plug 2 in a mold and injecting a molten resin into a cavity in the mold. An outer wall 11 surrounding the inner wall 12, and a step of producing the support 1 welded to the elastic plug 2 on the contact surface; and the inner wall 12 and the outer wall 11 of the support 1. A step of producing an inner plug 3 having an annular wall 31 that can be press-fitted into the gap of the inner wall 3, and an annular of the inner plug 3 in the gap between the inner wall 12 and the outer wall 11 of the support 1. At least a step of press-fitting the wall 31.

  The manufacturing process of the said support body 1 can be performed by conventionally well-known injection molding, two-color molding, etc., for example. That is, a mold capable of forming a cavity that enables the support 1 to be formed is prepared. Next, when the mold is closed, the elastic plug body 2 is provided therein. Subsequently, a resin that is a constituent material of the support 1 is melted, and this molten resin is injected into the cavity. The injection pressure of the molten resin at this time is not particularly limited, and can be set as necessary. The injected molten resin is cooled for a predetermined time. After the mold opening, the support body 1 in which the elastic plug 2 is welded to the inner wall 12 or the like is obtained.

  On the other hand, the manufacturing process of the inner plug 3 having the form shown in FIG. 1 can be performed by, for example, a conventionally known injection molding. That is, a mold capable of forming a cavity that enables the inner plug 3 to be formed when the mold is closed is prepared. Next, a resin that is a constituent material of the inner plug 3 is melted, and this molten resin is injected into the cavity. The injection pressure of the molten resin at this time is not particularly limited, and can be set as necessary. The injected molten resin is cooled for a predetermined time. After opening the mold, the inner plug 3 is obtained.

  Subsequently, the annular wall 31 of the inner plug 3 is press-fitted into the gap between the inner wall 12 and the outer wall 11. By this press-fitting, the annular wall 31 of the inner plug 3 can apply pressure to the outer wall 11 and the inner wall 12 of the support 1, and as a result, the elastic plug accommodated in the welded state of the inner wall 12 Pressure can also be applied to the body 2 via the inner wall 12. At this time, since the annular wall 31 of the inner plug 3 does not come into contact with the elastic plug body 2, unnecessary friction and resistance are not caused to the elastic plug body 2 when the annular wall 31 is press-fitted. As a result, it is possible to prevent the displacement of the elastic plug body 2 and improve the manufacturing efficiency. Moreover, since the adhesiveness between the elastic plug 2 and the inner wall 12 is excellent, it is possible to prevent the occurrence of liquid leakage when needle sticking is performed. In addition, the holding force and the restoring force against needle removal are excellent, and the resealability after needle removal can be improved.

  In addition, the medical cap which concerns on this Embodiment is not limited to the said aspect. For example, the medical cap 30 in the case where an inner plug 52 is provided at the tip of the mouth 51 in the infusion bottle 50 as shown in FIG. The mouth portion 51 and the inner stopper 52 in the infusion bottle 50 may be formed by combining mutually independent members, or may be formed integrally.

  In this case, the manufacturing process of the inner plug 52 shown in FIG. 4 can be performed by, for example, conventionally known blow molding. That is, a mold that can form a cavity that enables the outer surface of the inner plug 52 to be formed when the mold is closed and a blow pin that enables the inner surface of the mouth of the inner plug 52 to be formed are prepared. Next, a resin that is a constituent material of the inner plug 52 is melted, and a parison made of the molten resin is poured between the cavities. Thereafter, the cavity is closed and a blow pin is driven into the inner surface of the mouth portion to blow air. The blow pressure at this time is not particularly limited, and can be set as necessary. The molten resin formed by the cavity and the blow pin is cooled for a predetermined time. After opening the mold, the inner plug 52 is obtained.

  Even in these embodiments, since the support is welded at the contact surface with the elastic plug, for example, when the needle is inserted into the elastic plug, there is a gap due to the displacement of the elastic plug and the support. This can be further prevented. Furthermore, the occurrence of liquid leakage can be prevented and sealing performance can be ensured. Further, since the annular wall of the inner plug is press-fitted into the gap between the outer wall and the inner wall of the support body, it has excellent holding force and restoring force against needle removal, and also has a resealability after needle removal. Can be improved. Furthermore, since the annular wall 53 of the inner plug 52 is press-fitted without contacting the elastic plug body 2, the elastic plug body 2 is not deformed by friction during the press-fitting. As a result, displacement of the elastic plug body 2 can also be prevented.

  Moreover, in this Embodiment, the structure provided with the diaphragm part for coat | covering the liquid-contact surface 21 of the elastic stopper 2 may be sufficient. The thermoplastic elastomer material constituting the elastic plug 2 is an extremely sanitary material compared to the rubber material, but depending on the chemical used, there may be cases where contact with the elastic plug 2 is not preferable. 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 portion include a laminate film fused to the elastic plug 2, a film bonded to the inner plug 3, a membrane portion formed integrally with the inner plug 3, or a thin layer. The laminate film is not particularly limited, and a film that can be fused with the inner plug 3 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.

(Embodiment 2)
A medical cap according to another embodiment of the present invention will be described.
Compared with the medical cap according to the first embodiment, the medical cap according to the present embodiment is joined by a fitting structure instead of the structure in which the support and the inner plug are joined by welding of the flange portion. The difference is the adoption of a different structure. FIG. 5 is a schematic cross-sectional view for explaining the medical cap 60 according to the present embodiment. FIG. 6 is a schematic cross-sectional view for explaining a support body having an elastic plug body in the medical cap. FIG. 6A shows an elastic plug body integrally provided in the support body. FIG. 5B shows only the support member without the elastic plug body. FIG. 7 is a schematic cross-sectional view for explaining an inner plug in the medical cap. In the following, constituent elements having the same functions as those of the medical cap of the above-described embodiment are denoted by the same reference numerals, and detailed description thereof is omitted.

  As shown in FIGS. 5 and 6A, in the medical cap 60 according to the present embodiment, the inner plug 71 after press-fitting is maintained in that state on the top of the inner surface of the outer wall 11 of the support 61. An annular groove 62 is provided. The annular groove 62 may be any shape and size that can be fitted to a protrusion (details will be described later) of the annular wall 31 in the inner plug 71. Thereby, it is possible to prevent the inner plug 71 from being pushed out of the support body 61.

  The inner plug 71 has a configuration provided at the tip of a port 74 used for a container such as a bag for infusion or a bottle (see FIG. 7). Further, the port 74 and the inner plug 71 may be a combination of mutually independent members, or may be integrally formed.

  Further, an annular protrusion 62 for locking the inner plug 71 can be fitted to an annular groove 62 of the support body 61 at the peripheral edge of the bottom portion of the annular wall 31 of the inner plug 71. A portion 72 is preferably provided. Thereby, when the inner plug 71 is attached to the support body 61, the inner plug 71 can be prevented from being pushed out of the support body 61.

  In the present embodiment, the contact surface between the elastic plug body 2 and the support body 61, more specifically, the side peripheral surface 23 and the inner wall 12 of the elastic plug body 2, and the needle piercing surface 22 of the elastic plug body 2. It welds in the contact surface of the peripheral edge part of the side, and the mounting part 13. FIG. As a result, the elastic plug body 2 does not drop off or become misaligned during needle stick. As a result, in the inner plug 71, formation of a member for supporting the elastic plug body 2 from the liquid contact surface 21 side can be omitted.

  The constituent material of the inner plug 71 is the same as that described above. In addition, it is preferable that the inner plug 71 has an opening from the viewpoint that the needle plug surface 22 of the elastic plug body 2 can be easily stuck.

  In the present embodiment also, for the purpose of maintaining the state after the inner plug 3 is press-fitted into the support 61, the locking portion is provided at the top of the outer wall 11, and the bottom of the annular wall 31 is provided. An annular stepped portion that enables locking with the locking portion can be provided at the peripheral edge.

  In addition, the medical cap according to the present embodiment is provided with an annular ridge on the mounting portion 13 of the support 1, and an annular groove that allows the elastic plug 2 to be fitted with the ridge. It may be provided. Thereby, position shift and dropping of the elastic plug body 2 can be further prevented.

  Furthermore, the structure provided with the diaphragm part for coat | covering this on the liquid-contact surface 21 of the elastic plug body 2 is also employable. Thereby, also in this Embodiment, it can prevent that the elastic stopper body 2 contacts with a chemical | medical solution etc. There are no particular limitations on the dimensions, material, thickness, and the like of the diaphragm part, which are the same as those described in the first embodiment.

DESCRIPTION OF SYMBOLS 1 Support body 2 Elastic plug bodies 3, 52, 71 Inner plugs 10, 30, 60 Medical cap 11 External wall 12 Internal wall 13 Placement part 14 Notch part 17 Flange part 21 Liquid contact surface 22 Needle penetration surface 23 Side circumference Surface 31, 53 Annular wall 41, 74 Port 50 Infusion bottle 51 Mouth part 61 Support body 62 Annular groove 72 Projection part

Claims (4)

A medical cap having an elastic plug and a support for holding the elastic plug inside;
The support includes an inner wall that surrounds and accommodates the elastic plug, and an outer wall that surrounds the inner wall,
The inner wall of the support is provided with at least one notch,
In the gap between the inner wall and the outer wall, an inner plug having an annular wall is provided by press-fitting the annular wall,
The elastic plug is welded at the contact surface with the inner wall of the support, and is not welded to the inner plug.
A medical cap in which pressure is applied to the elastic plug body from the inner wall by press-fitting the annular wall. The top of the inner surface of the outer wall is provided with an annular groove for holding the press-fitted inner plug,
2. The medical device according to claim 1, wherein the inner plug is provided with an annular ridge that fits with the annular groove and engages the inner plug at a peripheral edge of a bottom portion of the annular wall. Cap. The medical cap according to claim 1 or 2, wherein the inner plug is provided at a distal end portion of a port used for an infusion solution bag . A method for producing a medical cap comprising an elastic plug and a support that holds the elastic plug inside.
An inner wall having at least one notch, the inner wall including and accommodating the elastic stopper by providing the elastic stopper in a mold and injecting molten resin into a cavity in the mold; An outer wall surrounding the wall, and producing the support welded to the elastic plug at the contact surface with the inner wall;
Producing an inner plug having an annular wall capable of being press-fitted into a gap between an inner wall and an outer wall in the support;
A method for producing a medical cap , comprising the step of press-fitting an annular wall in the inner plug into a gap between an inner wall and an outer wall in the support .

Images