JP2013039292A - Elastic stopper, medical cap and method for producing the same - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an elastic stopper having superior holding of sealing performance such as without liquid leakage in time of needle puncture, or with excellent holding force or resilience to needle coming-off, and to provide a medical cap including the same and a method for producing the medical cap.SOLUTION: This medical cap 10 includes: the elastic stopper 11; and an outer frame body 12 including an upper frame part 12a holding a peripheral part of the elastic stopper 11 from a needle puncture face 14 side by the inner wall thereof, and a lower frame part 12b holding it from a liquid contact face 15 side by the inner wall thereof. The lower frame part 12b is formed with at least one caulking part 18 for caulking the elastic stopper 11, and the elastic stopper 11 is formed with at least one cavity part 13 for integrally molding the caulking part 18 together with the outer frame body 12, in an optional position in a second peripheral part 19 of the liquid contact face 15. The elastic stopper 11 is not welded in a contact face with the upper frame part 12a, is welded in a contact face with the lower frame part 12b, and furthermore is welded in a contact face with the caulking part 18 in the cavity part 13, too.

Description

  The present invention relates to an elastic stopper used for closing a container such as an infusion container, a blood collection tube, and a vial, a medical cap, and a method for producing the same. In particular, an elastic plug, a medical cap, and a method for producing the same that do not leak when a puncture needle such as a medical plastic needle is inserted, have excellent holding force and restoring force against needle removal, and have excellent sealing performance About.

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

  As the medical cap provided with an elastic plug inside the outer frame, for example, a rubber plug as an elastic plug is at least on the entire side surface of the body part from a rubber plug outer frame as an outer frame. A mouthpiece for an infusion container that has been brought into close contact with each other under compressive stress has been proposed (see Patent Document 1 below). Patent Document 1 also describes that the mouthpiece for an infusion container is in a state where a rubber stopper and a rubber stopper outer frame are fused. Further, according to Patent Document 1, the rubber plug receives compressive stress from the outer frame body of the rubber plug, thereby increasing the tightening force on the piercing needle and the closing force of the hole generated by the needle piercing. Is disclosed.

  However, even in the case of a medical cap such as the mouthpiece for an infusion container, the close contact between the elastic stopper and the outer frame may not be sufficient. In such a medical cap, the position of the elastic stopper body and the outer frame body may be displaced during needle sticking, and a gap may be formed between them, so it is still difficult to perform needle sticking again. There is a problem.

JP-A-8-317961

  The present invention has been made in view of the above-mentioned problems, and the purpose thereof is an elastic plug having excellent sealing performance, such as no liquid leakage during needle sticking, and excellent retention and restoring force against needle removal, It is providing the medical cap provided with the same, and its manufacturing method.

  The inventors of the present application have studied an elastic plug, 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 elastic plug body according to the present invention is an elastic plug body used inside the outer frame body constituting the medical cap in order to solve the above-described problems, and is a pressurizing member for crimping the elastic plug body. At least one cavity portion for integrally forming the fastening portion with the outer frame body is provided at an arbitrary position on the peripheral edge portion of the liquid contact surface of the elastic plug body.

  The elastic plug body of the present invention is used inside the outer frame body constituting the medical cap. For example, the elastic plug body is inserted into the container via the puncture needle by performing needle insertion with the puncture needle on the elastic plug body. The function to take out the liquid. Here, as described above, the elastic plug according to the present invention is provided with a cavity for molding the crimped portion at the peripheral edge of the liquid contact surface. And by providing such a cavity part in an elastic plug body, the caulking part united with the outer frame body can be formed inside the cavity part in the molding process of the outer frame body. Moreover, since the cavity part is provided in the peripheral part of the liquid-contact surface of an elastic plug body, the crimping part shape | molded in the inside so that compressive stress may act toward the center of an elastic plug body Can be molded. That is, with the elastic plug body having the above-described configuration, a crimped portion formed integrally with the outer frame body can be formed in the manufacturing process of the medical cap, whereby the elastic plug body is in the crimped state. A retained medical cap can be provided. As a result, when performing puncture of a puncture needle, the medical device can prevent leakage of liquid inside the container, has excellent holding force and restoring force against needle removal, and further improves resealability after needle removal. Caps can be provided. The “liquid contact surface” refers to a surface of an elastic stopper that comes into contact with a chemical solution or the like when a medical cap is attached to a chemical solution bottle or an infusion bottle used for infusion.

  In the above configuration, the cavity portion has a hole shape toward the needle puncture surface side opposite to the liquid contact surface, or a groove shape toward the needle puncture surface side on the side peripheral surface of the elastic plug body. It is preferable to be provided. Here, the “needle puncture surface” is a surface in which an elastic stopper is attached to a medical solution bottle or an infusion bottle used for infusion and the like, and a needle is punctured by a puncture needle when taking out the chemical solution or the like. Say.

  In order to solve the above problems, the medical cap according to the present invention holds the elastic plug body, the upper frame portion that holds the elastic plug body on the inner wall from the needle puncture surface side, and the inner wall from the liquid contact surface side. A medical cap having an outer frame body having a lower frame portion, wherein the elastic plug body is integrally formed with a caulking portion for caulking the elastic plug body with the outer frame body. At least one cavity portion is provided at an arbitrary position on the peripheral portion of the liquid contact surface of the elastic plug, and the caulking portion integrated with the lower frame portion is provided in the cavity portion. The elastic plug body is not welded at the contact surface with the upper frame portion, and is welded at the contact surface with the lower frame portion, and in the cavity portion, Is also welded on the contact surface with the caulking portion.

  According to the above configuration, the elastic plug body is provided with the cavity portion for forming the caulking portion at the peripheral edge portion of the liquid contact surface, and the cavity portion is integrated with the outer frame body. The caulking portion is now provided. Further, the caulking portion is in a state of being welded to the elastic plug body inside the cavity portion. Furthermore, since the caulking part is provided at the peripheral edge of the liquid contact surface of the elastic plug, the compressive stress due to the caulking part acts toward the central part of the elastic plug. . That is, with the medical cap having the above-described configuration, the elastic plug body can be held inside the outer frame body in a state of being crimped by the crimping portion. As a result, it is possible to improve the adhesion between the elastic plug and the outer frame. Thereby, when performing puncture of the puncture needle, it is possible to prevent liquid leakage inside the container. In addition, the holding force and restoring force against needle removal are excellent, and the resealability after needle removal can be improved.

  In the above configuration, the lower frame portion is welded at the contact surface with the elastic plug, and the lower frame portion is welded at the contact surface with the upper frame portion. For this reason, for example, when needle sticking is performed from the side of the needle sticking surface, it is possible to prevent a gap from being generated due to the displacement of the elastic stopper and the lower frame part. As a result, the sealing performance can be improved.

  In the above configuration, the cavity portion in the elastic plug is provided in a hole shape toward the needle puncture surface side opposite to the liquid contact surface, or the needle puncture is provided on the side peripheral surface of the elastic plug. It is preferable that it is provided in a groove shape toward the surface side, and the caulking portion in the lower frame portion is provided in a columnar shape or a wall shape according to the shape of the cavity portion.

  A medical cap manufacturing method according to the present invention is a method for manufacturing a medical cap as described above in order to solve the above-described problem, and includes a process for caulking an elastic plug as the elastic plug. A cavity part for forming a fastening part integrally with the outer frame body is provided with at least one cavity part at the peripheral part of the liquid contact surface of the elastic plug body. Using the upper mold and the common lower mold, the upper frame portion capable of accommodating the elastic plug body is molded, and the elastic plug body is inserted into the upper frame section with the needle stick. When the second upper mold is used to form a cavity for molding the lower frame portion provided with the caulking portion when it is placed with the surface facing downward and combined with the common lower mold, Mold closing with the common lower mold and molding of the lower frame part and the caulking part molding And filling the cavity with molten resin, to form the lower frame portion having the crimp portion, and forming the outer frame body.

  According to the above method, first, the upper frame part that can accommodate the elastic plug body is formed using the first upper mold and the common lower mold. Next, the elastic stopper is placed inside the upper frame portion so that the needle stick surface faces downward. Further, the lower frame part is formed using the second upper mold and the common lower mold. When the second upper mold is combined with the common lower mold, a cavity for molding the lower frame portion is formed. Further, the elastic plug body is provided with a cavity portion for integrally forming the caulking portion with the outer frame body. In this state, the lower frame portion integrally formed with the caulking portion is formed by filling the molding cavity of the lower frame portion and the cavity portion for molding the caulking portion with molten resin. To do. In addition, when the said cavity part is provided in groove shape toward the needle puncture surface side in the side peripheral surface of an elastic plug body, a caulking part becomes integral with an upper frame part.

  The lower frame portion formed by the above method has a structure welded on the contact surface with the elastic plug. Further, the cavity portion of the elastic plug is also welded to the caulking portion. Furthermore, since the caulking portion is formed with the elastic plug body being caulked, the elastic plug body is held inside in a compressed state as compared with a normal case. As a result, according to the manufacturing method, a medical cap that has excellent adhesion between the elastic stopper and the outer frame and can prevent liquid leakage inside the container even when the needle is inserted into the puncture needle. Can be manufactured. In addition, a medical cap having excellent holding force and restoring force against needle removal and excellent resealability after needle removal can be obtained. Furthermore, even when needle puncturing is performed with a puncture needle, a gap is not generated due to a positional shift between the elastic stopper and the lower frame portion.

  According to the present invention, the elastic plug body includes the cavity portion capable of integrally forming the crimped portion capable of crimping the elastic plug body with the outer frame body. And, by providing the caulking part integrally with the outer frame body in the cavity part, the elastic plug body can be provided in close contact with the inside of the outer frame body in a state of being caulked by the caulking part. become. As a result, it is possible to prevent the liquid inside the container from leaking when the needle is pierced by the puncture needle. In addition, the holding force and the restoring force against needle removal are excellent, and the resealability after needle removal can be improved.

It is explanatory drawing for demonstrating the medical cap which concerns on Embodiment 1 of this invention, Comprising: The figure (a) represents the cross-sectional schematic diagram of the medical cap, The figure (b) is the figure (a). The AA sectional view taken on the line is shown. It is a top view which shows typically the elastic stopper in the said medical cap, Comprising: The same figure (a) represents the needle stick surface side, The same figure (b) represents the liquid-contact surface side. It is a cross-sectional schematic diagram showing the other aspect in the said medical cap, Comprising: The same figure (a) represents the case where a caulking part is a column shape, The same figure (b) is the case where the caulking part is a curved wall shape Represents. It is a cross-sectional schematic diagram in which the outer frame body in the said medical cap represents the aspect of a pull top type. It is a cross-sectional schematic diagram for demonstrating the manufacturing method of the said medical cap, Comprising: The same figure (a) represents a mode that the elastic stopper was mounted in the shape | molded upper side frame part, The same figure (b) The state where the common lower die and the second upper die are closed is shown, and FIG. 10C shows the state after the lower frame portion is molded. It is explanatory drawing for demonstrating the medical cap which concerns on Embodiment 2 of this invention, Comprising: The figure (a) represents the cross-sectional schematic diagram of the medical cap, The figure (b) is the figure (a). The BB arrow sectional drawing in is shown. It is a top view which shows typically the elastic stopper in the said medical cap, Comprising: The same figure (a) represents the needle stick surface side, The same figure (b) represents the liquid-contact surface side. It is a cross-sectional schematic diagram showing the other aspect in the said medical cap, Comprising: The cross-sectional schematic showing a mode that the crimping part was provided in the curved wall shape so that it may become flush with the side peripheral surface of an elastic plug body. FIG. 6 is a cross-sectional view schematically illustrating a medical cap according to Comparative Example 1. FIG.

(Embodiment 1)
An elastic plug, a medical cap, and a manufacturing method thereof according to Embodiment 1 of the present invention will be described below with reference to FIGS. However, parts that are not necessary for the description are omitted, and there are parts that are illustrated in an enlarged or reduced manner for ease of explanation.

  As shown in FIG. 1A, the medical cap 10 according to the first embodiment includes at least an elastic plug body 11 and an outer frame body 12 that holds the elastic plug body 11 therein. The outer frame body 12 includes an upper frame portion 12a that holds the elastic plug body 11 on the inner wall from the needle puncture surface 14 side, and a lower frame portion 12b that holds the elastic plug body 11 on the inner wall from the liquid contact surface 15 side. Become.

  The material which comprises the said outer frame 12 (namely, the upper frame part 12a and the lower frame part 12b) is not specifically limited, What is sufficient is just the safety | security for a medical use among synthetic resins. Of these, a thermoplastic resin is generally used. Specifically, resins conventionally used for medical applications such as polyethylene, polypropylene, and polyethylene terephthalate (PET) resin are preferable, but are not limited thereto. In the case of the pull-top type, as a material constituting the upper frame portion 12a, for example, a thermoplastic elastomer is preferable. More specific examples include olefin-based, styrene-based, polyurethane-based, polyester-based, polyvinyl chloride-based, and polybutadiene-based, but the present invention is not limited to these. Furthermore, you may add arbitrary components, such as a coloring agent, to the outer frame 12.

  The upper frame portion 12a and the elastic plug body 11 are in contact with each other at the first peripheral edge portion 21 (shaded area in FIG. 2A) and the side peripheral surface 22 of the needle piercing surface 14 of the elastic plug body 11. It is in a non-welded state at the contact portion. On the other hand, the lower frame portion 12b and the elastic plug body 11 are in contact with each other at the second peripheral edge portion 19 (the shaded area in FIG. 2B) of the liquid contact surface 15 of the elastic plug body 11. The part is in a welded state. The “welding” refers to, for example, a result of the surface of the elastic plug 11 in contact with the lower surface 12b being melted by the heat of the molten resin injected when the lower frame portion 12b is formed by injection molding. It means that the elastic plug body 11 and the lower frame portion 12b are in a combined state at the interface after the side frame portion 12b is molded.

  Further, four caulking portions 18 for integrally applying a compressive stress to the elastic plug 11 to be in a caulking state are integrally provided on the lower frame portion 12b. Due to the caulking portion 18, a compressive stress is exerted on the elastic plug body 11 toward the central portion thereof. On the other hand, the elastic plug body 11 tends to expand in the direction of the side peripheral surface of the elastic plug body 11 by the restoring force against the compressive stress. As a result, the sealing performance is improved between the elastic plug 11 and the upper frame portion 12a. The outer frame body 12 does not directly contribute to caulking the elastic plug body 11.

  Each caulking portion 18 is formed in a columnar shape inside the cavity portion 13 of the elastic plug 11, and is welded in the cavity portion 13. Further, as shown in FIG. 1B, these caulking portions 18 are provided concentrically on the second peripheral edge portion 19 of the elastic plug body 11 so as to be equally spaced from each other. Thus, by arranging the caulking portions 18 at equal intervals, the compressive stress on the elastic plug body 11 can be applied uniformly. In addition, by arranging the caulking portion 18 on the second peripheral edge portion 19 of the liquid contact surface 15, it is possible to ensure a needle sticking region with the puncture needle with respect to the elastic plug body 11.

  Further, the cross-sectional shape of the caulking portion 18 on the surface parallel to the needle puncture surface 14 of the elastic plug body 11 is a substantially rectangular shape in which two opposing long sides are curved convexly toward the outside of the elastic plug body 11. (See FIG. 1 (b)). In this way, the longer side is directed toward the center side of the elastic plug body 11 and the surface with the larger contact surface between the crimped portion 18 and the elastic plug body 11 is made to face the center of the elastic plug body 11, thereby providing elasticity. The compressive stress acting on the plug body 11 is increased. As a result, the effect of crimping on the elastic plug 11 is further enhanced. Although the cross-sectional area in the said cross-sectional shape of the crimping part 18 is not specifically limited, By changing this suitably, it becomes possible to adjust the compressive stress added to the elastic plug body 11. FIG. Specifically, the compressive stress on the elastic plug 11 can be further increased by increasing the cross-sectional area. However, it is preferable to arrange the caulking portion 18 so that the area of the contact portion between the caulking portion 18 and the elastic plug body 11 is the largest in the central direction of the elastic plug body 11. Thereby, a compressive stress can be made to act effectively in the direction which goes to the center of the elastic plug body 11. As a result, it is possible to prevent liquid leakage during needle sticking, and to further improve the holding force and restoring force against needle removal.

  It is preferable that the height h from the lower frame portion 12b of the crimping portion 18 is such that the crimping of the elastic plug body 11 sufficiently acts on the needle puncture surface 14 side. From such a viewpoint, it is preferably at least 15% or more and more preferably 45% or more with respect to the height t of the elastic plug body 11. The caulking portion 18 may penetrate the elastic plug body 11. In this case, the caulking portion 18 is in a welded state with the upper frame portion 12a, and can be a medical cap having excellent mechanical strength. Moreover, the height of each crimping part 18 may be the same, and may differ. However, when it is desired to apply a compressive stress uniformly to the elastic plug body 11, it is preferable that the heights of the caulking portions 18 are the same.

  Moreover, although the thickness of the crimping part 18 is made the same from the front-end | tip to the bottom, as shown to Fig.1 (a), this invention is not limited to this. For example, it may have a cross-sectional shape (a cross-sectional shape in a plane perpendicular to the needle puncture surface 14) that decreases in thickness as it goes toward the tip and becomes tapered, or may have a reverse cross-sectional shape.

  In the present embodiment, the four caulking portions 18 are provided at equal intervals. However, the present invention is not limited to this, and at least one caulking portion is provided. It only has to be done. For example, by further increasing the caulking portions 18 having the same cross-sectional shape, a uniform compressive stress can be applied to the elastic plug body 11 from more directions. As a result, it is possible to prevent the holding force and restoring force against needle removal, resealability after needle removal, and the like depending on the position of needle stick.

  As shown in FIGS. 2A and 2B, the elastic plug 11 has a columnar shape as a whole. The diameter d of the elastic plug 11 is not particularly limited as long as it can be accommodated inside the outer frame 12. Usually, it can set within the range of 12 mm-40 mm. In addition, the thickness t of the elastic plug 11 is not particularly limited, but can usually be set within a range of 3 mm to 10 mm. By making the thickness t 3 mm or more, it is possible to prevent the rigidity of the entire elastic plug body 11 from being lowered. On the other hand, by setting the thickness t to 10 mm or less, it is possible to prevent the needle stick with the puncture needle from becoming difficult. However, the present invention is not limited to this shape, and can be appropriately changed to any shape as necessary.

  As shown in FIG. 2A, one recess 16 for performing needle insertion of the puncture needle is provided at the center of the needle insertion surface 14 on the needle insertion surface 14 side of the elastic plug body 11. Further, on the side of the needle puncture surface 14, a needle puncture portion 17 is provided separately from the concave portion 16 for performing needle puncture with a metal needle during mixed injection for mixing and adjusting a plurality of drugs. The needle piercing portion 17 performs needle piercing with a metal needle and has a smaller outer diameter than a plastic needle or the like and is relatively easy to pierce, so that a cross-sectional shape having a conical shape can be used. Each needle stab portion 17 is located on a concentric circle outside the concave portion 16 provided at the center of the elastic plug body 11. Further, the needle stabs 17 are provided at equal intervals.

  On the liquid contact surface 15 side of the elastic plug body 11, as shown in FIG. 2B, four hole-shaped cavities 13 for forming the caulking portion 18 are provided. These cavity portions 13 are concentrically provided on the second peripheral edge portion 19 of the liquid contact surface 15 so as to be equally spaced from each other. The shape of the cavity portion 13 in a plan view from the liquid contact surface 15 side is not particularly limited, and is set according to the cross-sectional shape of the caulking portion 18. Further, the formation position and the number of the cavity portions 13 are also set according to the formation position of the caulking portion 18 and the like. Note that the depth of the cavity portion 13 corresponds to the height h of the caulking portion 18.

  Examples of the material used for the elastic plug 11 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 thermoplastic elastomer material is an extremely hygienic material compared to the rubber material, but depending on the chemical solution used, the liquid contact surface 15 of the elastic plug body 11 may be laminated. For laminating, the same type of resin as the outer frame 12 or the container body to be attached is generally used. Thereby, the contact surface 15 of the elastic plug 11 can be made of a material having the same or similar property as that in the container in contact with the chemical solution.

  The medical cap 10 according to the present embodiment as described above can be used by being attached to, for example, a container of a type that takes out a chemical solution with a needle. Specifically, the medical cap can be used as the take-out part in a medical bottle, a medical bag, or the like having a main body part for containing the chemical liquid and a take-out part for taking out the chemical liquid with a needle. As a result, it is possible to reduce the puncture resistance at the time of puncture of the puncture needle while preventing the leakage of the liquid and maintaining the holding force against the needle removal, and improve the ease of needle puncture as compared with the conventional medical cap. .

  The elastic plug and the medical cap according to the present invention are not limited to the embodiments shown in FIGS. 1 and 2, and various modifications can be made within the scope of the effects of the present invention. For example, the cross-sectional shape and the number of formed portions are not particularly limited, and can be set as necessary. Moreover, it does not specifically limit about the cross-sectional shape of a crimping part, For example, as shown to Fig.3 (a), the substantially circular crimping part 23 may be sufficient. The caulking portions 23 are concentrically provided at equal intervals from each other at the second peripheral edge portion 19 of the elastic plug body 24. The cavity portion 25 in the elastic plug body 24 is also provided in a substantially circular shape. Furthermore, the formation position of the crimping part should just be provided in the area | region of the 2nd peripheral part 19 by the side of the liquid contact surface 15 of the elastic plug body 11, and is not specifically limited. Further, the caulking portion is not limited to a columnar shape, and may be a wall-like caulking portion 26 as shown in FIG. 3B, for example. In this case, a plurality of the cavity portions 28 of the elastic plug body 27 are also provided as arcuate grooves.

  In the present embodiment, the medical cap 10 may be a pull-top type like the upper frame portion 12a 'shown in FIG. The upper frame portion 12a of the outer frame body 12 may be a pull-top type as shown in FIG. Moreover, in this Embodiment, the aspect which provided the flange as the lower side frame part 12b was shown. However, the present invention is not limited to this, and the flange can be omitted as appropriate.

Next, a method for manufacturing the medical cap 10 according to the present embodiment will be described.
First, the upper frame portion 12a is molded. The upper frame portion 12a is molded by, for example, injection molding using a first upper mold (not shown) and a common lower mold 31 (see FIG. 5A). The first upper mold and the common lower mold 31 have a structure in which a cavity that allows the cylindrical upper frame portion 12a to be formed is formed when the mold is closed.

  Next, a molten resin obtained by melting a resin that is a constituent material of the upper frame portion 12a is injected into the cavity. The injection conditions at this time are not particularly limited, and can be set as appropriate according to the material used. The injected molten resin is cooled for a predetermined time. After cooling, the upper frame portion 12a is formed by opening the mold.

  Next, as shown in FIG. 5A, the elastic stopper 11 is placed inside the upper frame portion 12a so that the needle piercing surface 14 faces downward, and injection molding of the lower frame portion 12b is performed. Do. In addition, it does not specifically limit as a manufacturing method of the elastic plug body 11, For example, it can manufacture by the compression molding performed by crushing the material containing a thermoplastic elastomer resin etc. and injection molding.

  The lower frame portion 12b is molded using the common lower mold 31 and the second upper mold 32. When the common lower mold 31 and the second upper mold 32 are closed, a cavity 33 capable of forming the lower frame portion 12b is formed.

  Next, a molten resin in which a resin constituting the lower frame portion 12b is melted is injected into the cavity 33 formed by mold closing. At this time, the molten resin is also injected into the molding cavity 13 of the caulking portion 18 in the elastic plug body 11. The injection conditions are not particularly limited, and can be set as necessary. The injected molten resin is cooled for a predetermined time. After the mold opening, as shown in FIG. 5C, the lower frame portion 12b is formed. Here, the contact portion between the elastic plug 11 and the lower frame portion 12b is in a welded state. The caulking portion 18 is formed integrally with the lower frame portion 12 b, and the caulking portion 18 is welded to the elastic plug body 11 in the cavity portion 13. Furthermore, the upper frame portion 12a and the lower frame portion 12b are also welded at the contact portion, and are integrated. However, the contact portion between the elastic plug 11 and the upper frame 12a is not welded.

  As described above, the medical cap 10 according to the present embodiment is obtained.

(Embodiment 2)
An elastic plug, a medical cap, and a manufacturing method thereof according to Embodiment 2 of the present invention will be described below with reference to FIGS. In addition, about the component which has the function similar to the medical cap 10 of the said Embodiment 1, the same code | symbol is attached | subjected and detailed description is abbreviate | omitted.

  As shown in FIG. 6, the medical cap 40 according to the second embodiment is provided with a cavity 44 in a groove shape toward the needle piercing surface 14 side on the side peripheral surface 22 of the elastic plug body 41. The medical cap 10 according to the first embodiment is different from the medical cap 10 according to the first embodiment in that a columnar caulking portion 43 is provided according to the shape of the cavity portion 44.

  The outer frame body 42 has an upper frame portion 42a for holding the side peripheral surface 22 of the elastic plug body 41 with the inner wall from the needle puncture surface 14 side, and a lower side for holding the elastic plug body 41 with the inner wall from the liquid contact surface 15 side. The point constituted by the frame part 42b is the same as in the case of the first embodiment. The upper frame portion 42a and the elastic plug body 41 are in contact with each other at the first peripheral edge 45 (shaded area in FIG. 7A) and the side peripheral surface 22 of the needle piercing surface 14 of the elastic plug body 41. It is in a non-welded state at the contact portion. On the other hand, the upper frame portion 42a is also in contact with the crimping portion 43, and the contact portion is in a welded state with the crimping portion 43.

  The lower frame portion 42b and the elastic plug body 41 are in contact with each other at the second peripheral edge portion 46 (the shaded area in FIG. 7B) of the liquid contact surface 15 of the elastic plug body 41. The peripheral edge 46 is welded.

  The lower frame portion 42b is integrally provided with four caulking portions 43 for applying a compressive stress to the elastic plug body 41 to obtain a caulking state. Each caulking portion 43 is formed in a columnar shape in the cavity portion 44 of the elastic plug body 41 and is welded in the cavity portion 13. Thereby, a compressive stress is acting on the elastic plug body 41 toward the central portion thereof. On the other hand, the elastic plug body 41 tends to expand in the direction of the side peripheral surface 22 of the elastic plug body 41 by the restoring force against the compressive stress. As a result, the sealing performance is improved between the elastic plug 41 and the upper frame portion 42a.

  Moreover, each caulking part 43 is flush with the side peripheral surface 22 of the elastic plug 41 as shown in FIG. Furthermore, each crimping part 43 is arrange | positioned so that it may become equal intervals mutually. By arranging the caulking portion 43 in this manner, the compressive stress on the elastic plug body 41 can be applied uniformly. Further, by arranging the caulking portion 43 on the second peripheral edge portion 46 of the liquid contact surface 15, an area for needle sticking with the puncture needle to the elastic plug body 41 is secured.

  Furthermore, as shown in FIG. 6B, the cross-sectional shape of the crimped portion 43 on the surface parallel to the needle puncture surface 14 of the elastic plug body 41 is such that the two opposing long sides are outside the elastic plug body 41. It is a substantially rectangular shape curved in a convex shape toward the surface. In this way, by facing the longer side toward the center side of the elastic plug body 41 and the larger contact surface between the crimped portion 43 and the elastic plug body 41 facing the center of the elastic plug body 41, The compressive stress acting on the elastic plug body 41 is increased. As a result, the effect of crimping on the elastic plug body 41 is further enhanced. The cross-sectional area in the cross-sectional shape of the caulking portion 43 is not particularly limited as in the case of the first embodiment, but the compressive stress applied to the elastic plug 41 can be adjusted by appropriately changing the cross-sectional area. It becomes possible. Specifically, the compressive stress on the elastic plug body 41 can be further increased by increasing the cross-sectional area. However, it is preferable to arrange the caulking portion 43 so that the area of the contact portion between the caulking portion 43 and the elastic plug body 41 is the largest in the central direction of the elastic plug body 41. Thereby, compressive stress can be made to act effectively in the direction which goes to the center of the elastic plug body 41. As a result, it is possible to prevent liquid leakage during needle sticking, and to further improve the holding force and restoring force against needle removal.

  The height of the caulking portion 43 is preferably such that the caulking on the elastic plug body 41 sufficiently acts on the side of the needle puncture surface 14 as in the case of the caulking portion 18 in the first embodiment. Specifically, it is preferably at least 15% or more and more preferably 45% or more with respect to the height of the elastic plug body 41. The caulking portion 43 may reach the needle puncture surface 14 side of the elastic plug 41. In this case, the caulking portion 43 is in a welded state with the upper frame portion 42a, and a medical cap having excellent mechanical strength can be obtained. Moreover, the height of each crimping part 43 may be the same, and may differ. However, when it is desired to apply a compressive stress uniformly to the elastic plug body 41, it is preferable that the heights of the caulking portions 43 are the same.

  Moreover, although the thickness of the crimp part 43 is made the same from the front-end | tip to the bottom, as shown to Fig.6 (a), this invention is not limited to this. For example, it may have a cross-sectional shape (a cross-sectional shape in a plane perpendicular to the needle puncture surface 14) that decreases in thickness as it goes toward the tip and becomes tapered, or may have a reverse cross-sectional shape. However, even in such a case, in the present embodiment, it is preferable that the caulking portion 43 is provided so as to be flush with the side peripheral surface 22 of the elastic plug body 41.

  In the second embodiment, the four caulking portions 43 are provided at equal intervals. However, the present invention is not limited to this, and at least one caulking portion is provided. It only has to be done. For example, by further increasing the caulking portions 43 having the same cross-sectional shape, a uniform compressive stress can be applied to the elastic plug body 41 from more directions. As a result, it is possible to prevent the holding force and restoring force against needle removal, resealability after needle removal, and the like depending on the position of needle stick.

  As the constituent materials of the elastic plug body 41 and the outer frame body 42, the same materials as in the first embodiment can be used. Further, the medical cap 40 according to the present embodiment can be manufactured according to the method described in the first embodiment.

  The caulking portion according to the present embodiment is not limited to the columnar form shown in FIGS. 6 and 7. For example, as shown in FIG. 8, the side peripheral surface 22 of the elastic plug body 49. Alternatively, a curved wall-shaped caulking portion 48 that is flush with the surface may be provided. In this case, the cavity portion 50 of the elastic plug body 49 is also formed to be flush with the side peripheral surface 22 of the elastic plug body 49.

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

Example 1
In this example, the medical cap having the structure shown in FIG. 1 was manufactured by the method for manufacturing a medical cap in the first embodiment (see FIG. 5). Polypropylene was used as the material for the upper and lower frame parts in the outer frame. As the material of the elastic plug, a styrene thermoplastic elastomer (grade for plug) was used. Furthermore, a two-color injection molding machine (trade name; DC100-200) manufactured by Nissei Plastic Industry Co., Ltd. was used as a molding machine for molding the outer frame.

The shape and dimensions of the elastic plug used in this example are as follows.
Elastic plug diameter D: 23 mm
Elastic plug thickness t: 6.6 mm
Cavity depth: 3.1 mm
Cavity part short side length a: 1.5 mm
Long side length b of the cavity part: 5 mm

The molding conditions of the upper frame part are as follows.
Injection molding temperature: 230 ° C
Injection pressure: 3MPa
Injection time: 3 seconds First upper mold temperature and common lower mold temperature: 32 ° C

The molding conditions of the lower frame part are as follows.
Injection molding temperature: 240 ° C
Injection pressure: 4MPa
Injection time: 3.4 seconds Second upper mold temperature and common lower mold temperature: 32 ° C.

(Example 2)
In this example, the medical cap having the structure shown in FIG. 6 was manufactured by the method for manufacturing a medical cap in the first embodiment (see FIG. 5). Polypropylene was used as the material for the upper and lower frame parts in the outer frame. As the material of the elastic plug, a styrene thermoplastic elastomer (grade for plug) was used. Furthermore, a two-color injection molding machine (trade name; DC100-200) manufactured by Nissei Plastic Industry Co., Ltd. was used as a molding machine for molding the outer frame.

The shape and dimensions of the elastic plug used in this example are as follows.
Elastic plug diameter D: 23 mm
Elastic plug thickness t: 6.6 mm
Cavity depth: 3.1 mm
Cavity portion short side length c: 1.5 mm
Long side length d of the cavity part: 5 mm

The molding conditions of the upper frame part are as follows.
Injection molding temperature: 230 ° C
Injection pressure: 3MPa
Injection time: 3 seconds First upper mold temperature and common lower mold temperature: 32 ° C

The molding conditions of the lower frame part are as follows.
Injection molding temperature: 240 ° C
Injection pressure: 4MPa
Injection time: 3.4 seconds Second upper mold temperature and common lower mold temperature: 32 ° C.

(Comparative Example 1)
In this comparative example, as shown in FIG. 9, a medical device including an outer frame body 62 having no caulking portion using an elastic plug body 61 not including a cavity portion for forming the caulking portion. Cap 60 was used. The outer frame body 62 is composed of an upper frame portion 62a that holds the elastic plug 61 from the needle puncture surface 63 side on the inner wall, and a lower frame portion 62b that holds the elastic stopper body 61 from the liquid contact surface 64 side on the inner wall. Is. Moreover, the said medical cap 60 was produced according to the manufacturing method (refer FIG. 5) of the medical cap in the said Embodiment 1 except not having provided the crimp part.

Elastic plug diameter D: 23 mm
Elastic plug thickness t: 6.6 mm

The molding conditions of the upper frame part are as follows.
Injection molding temperature: 230 ° C
Injection pressure: 3MPa
Injection time: 3 seconds First upper mold temperature and common lower mold temperature: 32 ° C

The molding conditions of the lower frame part are as follows.
Injection molding temperature: 240 ° C
Injection pressure: 3MPa
Injection time: 3.4 seconds Second upper mold temperature and common lower mold temperature: 32 ° C.

(Puncture needle holding force test)
The medical caps obtained in the examples and comparative examples were sterilized at 110 ° C. for 30 minutes by an autoclave. 20 samples of such medical caps were prepared, and metal needles (16G metal needles) and resin needles (Telfusion (registered trademark) infusion set TK-U200L, manufactured by Terumo Corporation) were inserted into the elastic stoppers. The holding power was examined. Each medical cap was pulled and set in a compression tester, and the following puncture needle attached to the tester was vertically punctured in the center of the elastic stopper, and then the puncture needle was raised at a speed of 200 mm / min. The force (unit: N) when the puncture needle was removed from the elastic plug was measured. As the puncture needle, the two kinds of needles were used, and the maximum value, the minimum value, the average value, and the standard deviation were obtained. The results are shown in Table 1 below.

(Puncture needle leak test)
The medical caps obtained in the examples and comparative examples were sterilized at 110 ° C. for 30 minutes by an autoclave. Next, each medical cap was attached to a test pressure can body, and a Terfusion (registered trademark) connecting tube (TC-00503B, manufactured by Terumo Corporation) was punctured at the drip site, and left for 4 hours. Thereafter, the needle was removed and checked for liquid leakage. The number of samples n was 200.

  Furthermore, each medical cap sterilized in the same manner as described above was attached to a test pressure can body, and an 18G metal needle was set in a syringe at the mixed injection site, and 10 ml of water was added and punctured vertically. Thereafter, the 18G metal needle was inclined with respect to the needle puncture surface, and water was injected and sucked into the test pressure can body three times. Subsequently, the second 18G metal needle was punctured and the operation of injecting and sucking water was repeated. Furthermore, the amount of liquid leakage after 1 hour was measured. The results are shown in Table 2 below. The number of samples n was 200.

10, 40 Medical cap 11, 24, 27, 41, 49 Elastic plug 12 Outer frame 12a Upper frame 12b Lower frame 13, 25, 28, 44, 50 Cavity 14 Needle stick surface 15 Wetted surface 16 Concave portion 17 Needle stick portion 18, 23, 26, 43, 48 Caulking portion 19 Second peripheral portion 21 First peripheral portion 22 Side surface 31 Common lower die 32 Second upper die 33 Cavity 42 Outer frame 42a Upper frame part 42b Lower frame part 45 First peripheral part 46 Second peripheral part

Claims (5)

An elastic plug used inside the outer frame constituting the medical cap,
At least one cavity portion for forming a caulking portion for caulking the elastic plug body integrally with the outer frame body is provided at an arbitrary position in the peripheral portion of the liquid contact surface of the elastic plug body. Elastic plug body that has been.   The cavity portion is provided in a hole shape toward the needle puncture surface side opposite to the liquid contact surface, or in a groove shape toward the needle puncture surface side on the side peripheral surface of the elastic plug body. The elastic plug body according to claim 1. A medical cap having an elastic plug body and an outer frame body having an upper frame portion that holds the elastic plug body on the inner wall from the needle puncture surface side and a lower frame portion that holds the elastic plug body on the inner wall from the liquid contact surface side. And
In the elastic plug body, a cavity portion for integrally forming a caulking portion for caulking the elastic plug body with the outer frame body is provided at any peripheral portion of the liquid contact surface of the elastic plug body. At least one in position,
The cavity portion is provided with the caulking portion integrated with the lower frame portion,
The elastic plug body is not welded at the contact surface with the upper frame portion, and is welded at the contact surface with the lower frame portion, and also in the cavity portion, Medical cap welded on the contact surface. The cavity portion in the elastic plug body is provided in a hole shape toward the needle puncture surface side opposite to the liquid contact surface, or on the side peripheral surface of the elastic plug body toward the needle puncture surface side. It is provided in a groove shape,
The medical cap according to claim 3, wherein the caulking portion in the lower frame portion is provided in a columnar shape or a wall shape according to the shape of the cavity portion. It is a manufacturing method of the medical cap of Claim 3 or 4,
As the elastic plug body, a cavity portion for forming a caulking portion for caulking the elastic plug body integrally with the outer frame body is at an arbitrary position in the peripheral portion of the liquid contact surface of the elastic plug body. Prepare at least one provided,
Using the first upper mold and the common lower mold, the upper frame part capable of accommodating the elastic plug body is molded,
Inside the upper frame part, the elastic stopper is placed with the needle stick surface facing downward,
When combined with the common lower mold, using the second upper mold that forms a cavity for molding the lower frame portion provided with the caulking portion, the mold is closed with the common lower mold,
Filling the molding cavity of the lower frame part and the cavity part for molding the caulking part with molten resin, molding the lower frame part provided with the caulking part, and forming the outer frame body. A method for producing a medical cap.

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