JP2009247692A - Medical cap and its manufacturing method - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a manufacturing method of a medical cap which is excellent in adhesion between an elastic plug body and an outer frame body holding its peripheral part on an inner wall, and does not cause displacement of the elastic plug body and the outer frame body by punctuation, so as to successfully secure airtightness. <P>SOLUTION: This invention relates to the manufacturing method of the medical cap having an elastic plug body and an outer frame body which holds its side peripheral part on an inner wall, wherein a lower mold having a first ring projection part of an outside diameter smaller than a diameter of the elastic plug body and an upper mold having a second ring projection part of the outside diameter small than the diameter of the elastic plug body, are prepared, and the elastic plug body is placed on the first ring projection part of the lower mold part, and molds of the upper mold and the lower mold are closed, thereby a cavity for molding the outer frame body is formed in a state where the peripheral part of the elastic plug body is pressed from up and down by the first ring projection part and the second ring projection part, and melted resin is injected in the cavity to mold the outer frame body. <P>COPYRIGHT: (C)2010,JPO&INPIT

Description

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

  For medical solution bottles used in the medical field and infusion bottles used for infusions, rubber caps and rubber or elastomeric resins for needle sticks inside the outer frame body are used as caps so that the chemicals can be taken out with a needle. What provided the plug body which consists of is used. This outer frame is attached to the infusion container by a method such as welding. In use, the infusion solution in the container is taken out by inserting a needle into the stopper and lowering the cap. Therefore, such a medical cap is required to have hermetic properties in order to prevent leakage of chemicals and infusions and to prevent deterioration due to contact with air.

  For example, in the structure of the medical cap, the liquid contact surface of the plug body and the upper portion of the bottom surface holding portion of the outer frame body are fused, and the side wall of the plug body and the inner wall of the side periphery of the outer frame body Has been proposed to provide a medical cap that is improved in rubber characteristics and excellent in resealability by being brought into contact in a non-fused state (see Patent Document 1 below).

JP-A-2005-118185

  However, in the case of a conventional medical cap, the close contact between the plug body and the outer frame body may not be sufficient. In such a medical cap, the position of the plug 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.

  The present invention has been made in view of the above-mentioned problems, and the object thereof is excellent in adhesiveness between the elastic plug body and the outer frame body holding the peripheral edge portion thereof by the inner wall, and the elastic plug body and the outer frame body by needle sticking. It is an object of the present invention to provide a medical cap and a method for manufacturing the same that are excellent in ensuring sealing performance.

  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 method for manufacturing a medical cap according to the present invention is a method for manufacturing a medical cap having an elastic plug and an outer frame that holds the side peripheral portion thereof with an inner wall in order to solve the above-described problems. A lower mold having a first ring-shaped protrusion having an outer diameter smaller than the diameter of the elastic plug, and an upper metal having a second ring-shaped protrusion having an outer diameter smaller than the diameter of the elastic plug. Preparing the mold, placing the elastic stopper on the first ring-shaped projection of the lower mold, and closing the upper mold and the lower mold to form the first ring-shaped projection And forming a cavity for molding the outer frame body in a state where the peripheral edge portion of the elastic plug body is pressed from above and below by the second ring-shaped protrusion, and injecting molten resin into the cavity to form the outer frame body Is formed.

  In the manufacturing method of the present invention, the outer frame body is molded in a state where the first ring-shaped protrusion and the second ring-shaped protrusion press the peripheral edge of the elastic plug body from above and below. In such a method of forming the outer frame body, the elastic plug body has a compressive stress (caulking force) from the side peripheral portion toward the center than the outer frame body holding the side peripheral portion of the elastic plug body with the inner wall. Become working. As a result, it is possible to produce a medical cap with improved adhesion between the elastic stopper and the inner wall of the outer frame, improved holding force and restoring force against needle removal, and excellent resealability after needle removal. it can. Further, the outer frame body has a structure that is fused at the contact surface with the elastic plug body. Therefore, for example, when a needle is inserted from the upper surface side, a gap is prevented from being generated due to the displacement of the elastic plug body and the outer frame body, and as a result, a medical cap having an excellent medicinal solution sealing performance can be obtained.

  In the above method, the inner height of the first ring-shaped protrusion in the lower mold is higher than the height of the second ring-shaped protrusion in the upper mold, and the upper mold When the lower mold is closed, it is preferable that the lower surface of the elastic plug body swells more convexly than the upper surface. Thereby, while suppressing that the center part in the upper surface side of an elastic stopper body bulges upwards upwards, the medical cap swelled so that a lower surface side may become a convex surface is obtained. As a result, a medical cap capable of preventing contact with the peel film for sealing the elastic plug on the upper surface side of the elastic plug is obtained.

  In addition, a medical cap according to the present invention is a medical cap obtained by the method for manufacturing a medical cap described above, in order to solve the above-described problem, and the elastic plug body includes the outer frame body and the medical cap body. The contact surface is fused, and at least the lower surface of the elastic plug is a convex surface that bulges downward toward the lower side.

  The medical cap of the present invention has a structure in which the outer frame is fused on the contact surface with the elastic plug. For this reason, for example, when needle sticking from the upper surface side, it is possible to prevent a gap from being generated due to the displacement of the elastic plug body and the outer frame body, and it is possible to ensure the sealing property of the chemical solution. In addition, since the outer frame body is in a state in which a compressive stress (caulking force) is applied from the side peripheral portion of the elastic plug body toward the center, the adhesion between the elastic plug body and the outer frame body is improved, and the needle can be removed. Holding force and restoring force are improved, and resealability after needle removal is also excellent.

  The outer frame body has a sticking portion to which a peel film for sealing the elastic plug body can be attached, and when the peel film is detachably attached to the sticking portion, It is preferable not to contact. As a result, the gap between the elastic plug and the peel film can be reduced, and the volume of air sealed by the peel film can be reduced. For example, during sterilization, deformation of the peel film due to volume change of the sealed air Can be prevented.

  In the above-described configuration, the upper surface of the elastic plug is swelled more convexly than the upper surface so that the upper surface of the elastic plug is a needle piercing surface and the lower surface is a wetted surface, and the upper surface is not in contact with the peel film. A convex surface is preferred.

  In the above configuration, the elastic plug body preferably includes a thermoplastic elastomer. Thereby, a restoring force improves and it can provide the medical cap excellent in the needle holding force during infusion treatment and the resealability after needle removal.

  Further, the medical bottle according to the present invention is a medical bottle having at least a bottle main body for storing a chemical solution and an extraction portion for taking out the chemical solution with a needle, wherein the extraction portion is the medical cap described above. It is characterized by.

  Embodiments of the present invention will be described below with reference to the drawings. 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. FIGS. 1-9 is sectional drawing for demonstrating the manufacturing method of the medical cap based on this Embodiment.

  First, an upper mold and a lower mold used in the method for manufacturing a medical cap according to the present embodiment will be described.

  As shown in FIG. 1, the outer frame body is injection-molded using an upper mold 11 and a lower mold 12. In the present embodiment, the upper mold 11 is a fixed mold, and the lower mold 12 is a movable mold. The upper mold 11 and the lower mold 12 have a structure in which a cavity capable of forming a cylindrical outer frame is formed when the mold is closed.

  The upper mold 11 has a convex portion 11 a, whereby a gap is formed between the peel film and the upper surface 13 a of the elastic plug 13. Moreover, it has the 2nd ring-shaped projection part 11b which has an outer diameter smaller than the diameter of the upper surface 13a of the elastic plug body 13. As shown in FIG.

  The planar shape of the convex portion 11a is not particularly limited, but is preferably, for example, a circular shape. When the convex portion 11a has a circular shape, its diameter (outer diameter) is equal to the distance obtained by subtracting the width of the peel film sticking portion from the outer diameter of the outer frame body 15.

  The tip of the second ring-shaped protrusion 11b is a flat surface as shown in FIG. 2 (a), and has a surface roughness increased by electric discharge machining or the like as shown in FIG. As shown in FIG. 5C, the tip may have a shape having a minute protrusion. Moreover, as shown to the same figure (d), uneven | corrugated shape may be sufficient. With these shapes, the second ring-shaped protrusion 11b enables the elastic plug 13 to be pressed in a state where the upper surface 13a of the elastic plug 13 is securely gripped. The shape of the tip is the same for the first ring-shaped protrusion 12a in the lower mold 12 described later.

  The height h1 of the second ring-shaped protrusion 11b can be appropriately set according to the thickness of the elastic plug 13 or the height of the first ring-shaped protrusion described later. Usually, it is preferably within a range of 0.5 to 8 mm, for example, and more preferably within a range of 1 to 6 mm. If h1 is less than 0.5 mm, the peripheral edge of the upper surface 13a of the elastic plug 13 may not be sufficiently pressed. On the other hand, when h1 exceeds 8 mm, the pressure against the peripheral portion becomes excessive, and the upper surface 13a of the elastic plug 13 is not circular but distorted. Further, there is a problem that the upper mold 11 and the lower mold 12 are not sufficiently clamped. In the present embodiment, the height on the outside and the inside on the second ring-shaped protrusion 11b may be the same, but the height on the inside of the second ring-shaped protrusion 11b is increased. The caulking effect on the elastic plug 13 can be improved.

  The outer diameter d1 of the second ring-shaped protrusion 11b is not particularly limited as long as it is smaller than the diameter of the upper surface 13a of the elastic plug 13, and can be appropriately set according to the shape and size of the elastic plug 13 to be inserted. . When the diameter of the upper surface 13a is s1 and this is used as a reference, the outer diameter d1 is preferably in the range of (s1-0.2) to (s1-20) mm, and (s1-0. More preferably, it is within the range of 4) to (s1-15) mm. When d1 is less than (s1-0.2) mm, the end of the upper surface 13a of the elastic plug 13 enters the inside of the second ring-shaped protrusion 11b during mold clamping. In some cases, the body 13 is molded in a distorted state such as being held biased to one side. On the other hand, when d1 exceeds (s1-20) mm, the deformation of the elastic plug body 13 due to the pressing of the second ring-shaped projection 11b is directed to the outside rather than the inside of the second ring-shaped projection 11b. As a result, the upper surface 13a may not be deformed so as to be a convex surface. The s1 is not particularly limited, and is usually set within a range of 5 to 35 mm. However, when the elastic plug does not have a stepped portion, the diameter s1 of the upper surface coincides with the diameter of the elastic plug. Therefore, s1 in such a case is set within a numerical range of the diameter of the elastic plug described later.

  The second ring-shaped protrusion 11b may be a single continuous ring-shaped protrusion as shown in FIG. 3 (a), or may have a uniform height on the circumference as shown in FIG. 3 (b). A plurality of pins may be raised to form a ring-shaped protrusion as a whole.

  The lower mold 12 has a first ring-shaped protrusion 12a on the bottom surface. The height h2 of the first ring-shaped protrusion 12a is preferably in the range of 0.5 to 8 mm, for example, and more preferably in the range of 1 to 6 mm. If h2 is less than 0.5 mm, the peripheral edge portion of the lower surface 13b of the elastic plug 13 may not be sufficiently pressed. On the other hand, when h2 exceeds 8 mm, the pressure on the peripheral portion becomes excessive, and the lower surface 13b of the elastic plug 13 is not circular but distorted. Further, there is a problem that the upper mold 11 and the lower mold 12 are not sufficiently clamped. In addition, the inner height h3 of the first ring-shaped protrusion 12a is preferably higher than the outer height h2. Thereby, when the upper mold 11 and the lower mold 12 are closed, a space for making the lower surface 13b of the elastic plug 13 a convex surface that is larger than the upper surface 13a can be secured. From such a viewpoint, the inner height h3 of the first ring-shaped protrusion 12a is preferably larger than the inner height of the second ring-shaped protrusion 11b. Specifically, the height h3 of the first ring-shaped protrusion 12a is preferably in the range of 0.7 to 15 mm, for example, and more preferably in the range of 1.3 to 11 mm. Thereby, when the upper surface 13a is a needle stick surface and the lower surface 13b is a liquid contact surface, it is possible to prevent the peel film provided on the upper surface 13a side from coming into contact with the upper surface 13a.

  The outer diameter d2 of the first ring-shaped projecting portion 12a is not particularly limited as long as it is smaller than the diameter of the lower surface 13b of the elastic plug body 13, and can be appropriately set according to the shape and size of the outer frame body 15 to be inserted. . When the diameter of the lower surface 13b is s2 and this is used as a reference, the outer diameter d2 is preferably in the range of (s2-0.2) to (s2-20) mm, and (s2-0. 4) to (s2-15) mm is more preferable. When d2 is less than (s2-0.2) mm, the end of the lower surface 13b of the elastic plug body 13 enters the inside of the first ring-shaped protrusion 12a during mold clamping. There are cases where the body 13 is molded in a distorted state such as being held biased to one side. On the other hand, when d2 exceeds (s2-20) mm, the deformation of the elastic plug body 13 due to the pressing of the first ring-shaped protrusion 12a is directed to the outside rather than the inside of the first ring-shaped protrusion 12a. As a result, the lower surface 13b may not be deformed so as to be a convex surface. The s2 is not particularly limited, and is usually set within a range of 5 to 35 mm. Further, s2 may be the same as or different from s1. However, when the elastic plug does not have a step portion, the diameter s2 of the lower surface matches the diameter of the elastic plug. Accordingly, s2 in such a case is set within a numerical range of the diameter of the elastic plug described later.

  Here, the shape, position, and size of the first ring-shaped protrusion 12a and the second ring-shaped protrusion 11b are not particularly limited, and various combinations are possible within the above-described numerical range. For example, as shown in FIG. 4A, the outer diameter d2 of the first ring-shaped protrusion 12a and the outer diameter d1 of the second ring-shaped protrusion 11b are the same, and the upper mold 11 and the lower mold When the mold 12 is closed, both positions may coincide with each other. Further, as shown in FIG. 4B, the outer diameter d1 of the second ring-shaped protrusion 11b may be larger than the outer diameter d2 of the first ring-shaped protrusion 12a. As shown in FIG. 4 (c), the outer diameter d2 of the first ring-shaped protrusion 12a may be larger than the outer diameter d1 of the second ring-shaped protrusion 11b.

  Further, regarding the height of the first ring-shaped protrusion 12a and the second ring-shaped protrusion 11b, as shown in FIG. 5A, the height h2 of the first ring-shaped protrusion 12a and the second ring shape You may make the height h1 of the projection part 11b the same. Further, as shown in FIG. 5 (b), the height h2 of the first ring-shaped protrusion 12a may be higher than the height h1 of the second ring-shaped protrusion 11b. As shown in FIG.5 (c), the height h1 of the 2nd ring-shaped projection part 11b may be higher than the height h2 of the 1st ring-shaped projection part 12a.

  Further, regarding the widths of the first ring-shaped protrusion 12a and the second ring-shaped protrusion 11b, as shown in FIG. 6A, the width w2 of the first ring-shaped protrusion 12a is set to the second ring-shaped protrusion 12a. It may be narrower than the width w1 of 11b. Further, as shown in FIGS. 6B and 6C, the width w2 of the first ring-shaped protrusion 12a and the width w1 of the second ring-shaped protrusion 11b are both increased or decreased. You may make it the same in a state. Further, as shown in FIG. 6 (d), the width w1 of the second ring-shaped protrusion 11b may be narrower than the width w2 of the first ring-shaped protrusion 12a.

  For example, the width w2 of the first ring-shaped protrusion 12a is preferably in the range of 0.2 to 3.5 mm, and more preferably in the range of 0.3 to 2.5 mm. On the other hand, the width w1 of the second ring-shaped protrusion 11b is preferably in the range of 0.2 to 3.5 mm, for example, and more preferably in the range of 0.3 to 2.5 mm.

  The first ring-shaped protrusion 12a may be a single continuous ring-shaped protrusion as shown in FIG. 7 (a), or may have a uniform height on the circumference as shown in FIG. 7 (b). A plurality of pins may be raised to form a ring-shaped protrusion as a whole.

  Next, the manufacturing method of the medical cap which concerns on this Embodiment is demonstrated. First, as shown in FIG. 1, the elastic plug 13 is placed on the first ring-shaped protrusion 12 a of the lower mold 12. At this time, the elastic plug 13 is placed so that the upper surface 13a is a needle puncture surface and the lower surface 13b is a liquid contact surface. Here, the needle puncture surface means a surface where the medical cap of the present invention is attached to an infusion bottle used for a drug solution bottle or an infusion, and needle stick is performed by an injection needle when taking out the drug solution or the like. Further, the liquid contact surface means a surface in contact with a chemical solution or the like.

  Next, as shown in FIG. 8, the upper mold 11 and the lower mold 12 are closed. At this time, the peripheral edge of the elastic plug 13 is pressed from above and below by the first ring-shaped protrusion 12a and the second ring-shaped protrusion 11b. At this time, since the inner height h3 of the first ring-shaped protrusion 12a is larger than the height h1 of the second ring-shaped protrusion 11b, the first ring-shaped protrusion 12a on the lower surface 13b of the elastic plug 13 is provided. The inner part of is pushed downward. Further, by closing the upper mold 11 and the lower mold 12, a cavity 14 for forming an outer frame is formed.

  Subsequently, a molten resin obtained by melting a resin that is a constituent material of the outer frame body 15 is injected into the cavity 14 through the sprue and the runner in the upper mold 11. The injection pressure is not particularly limited, and can be set as necessary. The injected molten resin is cooled for a predetermined time. After the mold is opened, the outer frame body 15 is formed as shown in FIG. Thus, the medical cap 30 including the elastic plug body 13 and the outer frame body 15 that holds the side peripheral portion 13c of the elastic plug body 13 with the inner wall is obtained (see FIG. 10). In addition, this invention is not limited to injection molding, It is also possible to employ | adopt compression molding.

  In the medical cap 30 obtained by the manufacturing method, the contact portion between the elastic plug 13 and the outer frame 15 is fused. Further, a force 52 for pressing the outer frame body 15 is applied to the surface layer portions of the upper surface 13a and the lower surface 13b of the elastic plug body 13 in directions indicated by arrows in FIG. Further, a compressive stress (caulking force) acts on the elastic plug body 13 from the side peripheral portion 13c toward the center as a reaction of the force 52 pushing the outer frame body 15. Thereby, the adhesiveness between the elastic plug 13 and the outer frame 15 is improved, the holding force and the restoring force against needle removal are improved, and the resealability after needle removal is excellent. Further, the restoring force 51 of the elastic plug 13 works in the direction indicated by the arrow.

  In addition, the lower surface 13b (wetted surface) of the elastic plug body 13 swells so that the central portion becomes a more convex surface than the upper surface 13a (needle stab surface). The height of the central portion of the upper surface 13a of the elastic plug body 13 is preferably suppressed to 1.5 mm or less with reference to the peripheral edge portion. This prevents the peel film 29 from coming into contact with the upper surface 13a of the elastic plug body 13 even when the peel film 29 for sealing the elastic plug body 13 is stuck to the sticking portion 29a of the outer frame body 15. it can. Further, since the gap between the elastic plug 13 and the peel film 29 can be reduced and the volume of the air sealed by the peel film 29 can be reduced, for example, during sterilization, the peel film 29 due to the volume change of the sealed air Can be prevented from being deformed. Furthermore, as a result of preventing the swelling on the upper surface 13a of the elastic plug body 13, the difference between the sticking portion 29a and the central portion in the outer frame body 15 can be suppressed to 2 mm or less, which is hindered by the outer frame body 15. Therefore, the needle can be inserted without improving the workability. Note that the peeling of the peel film 29 to the sticking portion 29a is performed so as to be peelable by, for example, heat sealing.

  The outer diameter D of the outer frame body 15 is preferably in the range of 6 to 50 mm, and more preferably in the range of 8 to 45 mm. Further, the distance h between the peel film 29 and the upper surface 13a of the elastic plug 13 when the peel film 29 is attached to the attaching portion 29a is preferably 2 mm or less, and more preferably 1.5 mm or less. Further, the width W of the sticking part 29a is preferably in the range of 0.5 to 8 mm, and more preferably in the range of 0.8 to 5 mm.

  In addition, as a material which comprises the said outer frame body 15, the safety | security for a medical use is established among synthetic resins. 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. Moreover, you may add arbitrary components, such as a coloring agent, to the outer frame 15.

  Moreover, as a material used for the said elastic plug body 13, rubber | gum and a thermoplastic elastomer are mentioned, for example. 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. However, depending on the chemical solution used, the liquid contact surface 13b of the elastic plug 13 may be laminated. For laminating, the same type of resin as the outer frame 15 or the container body to be attached is generally used. Thereby, it can be set as the material of the same or similar property in the container which a chemical | medical solution contacts, and the liquid-contact surface 13b of the elastic plug body 13.

  Moreover, it is preferable that the cross-sectional shape of the elastic plug body of the present invention is a shape that does not hinder the flow of molten resin obtained by melting the resin that is a constituent material of the outer frame body 15 when filling the cavity. From this point of view, as an elastic plug body, as shown in FIG. 11A, a standard-shaped elastic plug body 13 having a stepped portion 13d on the side peripheral portion 13c can be cited. In particular, by providing the step portion 13d, the filling pressure of the molten resin can be reduced. Further, when the gate position of the molding portion of the outer frame 15 is closer to the center, the deformation of the elastic plug 13 due to the filling pressure of the molten resin is limited to the thin side peripheral portion 13c, and the elastic plug 13 The entire deformation can be prevented. Further, since the side peripheral portion 13c is fused with the outer frame body 15 and its contact surface, it is possible to suppress the elastic plug body 13 from falling off the outer frame body 15. Further, as shown in FIG. 11B, there is an elastic plug body 41 in which a stepped portion 41c is provided on both the needle puncture surface 41a and the liquid contact surface 41b to prevent the dropout. Furthermore, as shown in FIG. 11C, both the needle puncture surface 42a and the liquid contact surface 42b may be flat elastic plugs 42. Furthermore, as shown in FIG. 11 (d), an annular groove 43c having the same diameter as the diameter of the second ring-shaped protrusion 11b of the upper mold 11 is provided on the needle puncture surface 43a side, and the drop-off prevention is provided on the liquid contact surface 43b side. The elastic plug body 43 provided with the level | step-difference part 43d for this may be sufficient. The annular groove 43c makes it possible to prevent the elastic plug 13 from being deformed and dropped during puncturing. Furthermore, as shown in FIG. 11 (e), an elastic plug body 44 is provided with an annular protrusion 44c on the needle puncture surface 44a side and a stepped portion 44d for preventing the dropout on the liquid contact surface 44b side. It may be. The protrusion 44c makes it possible to prevent the elastic plug body 13 from being deformed and dropped during puncturing. Further, as shown in FIG. 11 (f), a step 45 c may be provided only on the needle puncture surface 45 a, and the liquid contact surface 45 b may be a flat elastic plug 45.

  The diameter of the elastic plug 13 is not particularly limited, and is usually set within a range of 12 to 40 mm. The diameter s1 of the upper surface and the diameter s2 of the lower surface of the elastic plug 13 are as described above. Furthermore, the thickness of the elastic plug 13 is not particularly limited, and can usually be set within a range of 3 to 15 mm.

  The method for producing the elastic plug 13 is not particularly limited, and for example, it can be produced by compression molding or injection molding performed while crushing a thermoplastic elastomer.

  The medical cap of the present invention is used, for example, by being attached to a container of a type that takes out a chemical solution with a needle. Specifically, in a medical bottle having a bottle main body for storing a chemical solution and an extraction portion for taking out the chemical solution with a needle, the medical bottle having excellent sealing performance can be obtained using the cap of the present invention as the extraction portion. it can.

  Hereinafter, preferred embodiments of the present invention will be described in detail by way of example. However, the materials, blending amounts, and the like described in the examples are not intended to limit the scope of the present invention only to them, but are merely illustrative examples, unless otherwise specified.

Example 1
In this example, the medical cap 30 shown in FIG. 10 was manufactured according to the method shown in FIGS. LDPE (low density polyethylene, MFR = 1) was used as the material of the outer frame 15, and styrene-based thermoplastic elastomer was used as the material of the elastic plug 13. As a molding machine, an injection molding machine (trade name: SG-50) manufactured by Sumitomo Heavy Industries, Ltd. was used.

The shape dimensions of the first ring-shaped protrusion of the lower mold and the second ring-shaped protrusion of the upper mold are as follows.
1st ring-shaped protrusion outside height h2: 2.0 mm
Inner height h3: 3.0 mm
Width w2: 0.5mm
Outer diameter d2: 14.5mm
Tip shape: Plane Second ring-shaped protrusions Outside and inside heights h1: 1.0 mm
Width w1: 1.3mm
Outer diameter d1: 16.0mm
Tip shape: Plain

The molding conditions of the outer frame 15 are as follows.
Injection molding temperature: 230 ° C
Injection pressure: 4.1 MPa
Injection time: 3.1 seconds Upper mold temperature and lower mold temperature: 43 ° C

(Example 2)
In the present example, the medical cap 31 provided with the outer frame body 15 ′ shown in FIG. 12 was produced according to the method shown in FIGS. The materials of the outer frame body 15 ′ and the elastic plug body 13 were the same as in Example 1, and the same molding conditions and injection molding machine were used except that the injection pressure was set to 4.7 MPa.

(Comparative Example 1)
In this comparative example, an injection molding machine manufactured by Sumitomo Heavy Industries, Ltd. having a lower mold not provided with the first ring-shaped protrusion and an upper mold not provided with the second ring-shaped protrusion (product) The medical cap 101 which concerns on this comparative example was produced like the said Example 1 except having used the name; SG-50) (refer FIG. 13). The obtained medical cap 101 is composed of an elastic plug body 103 and an outer frame body 105 that holds the side peripheral portion thereof with an inner wall, and the lower surface 103a and the upper surface 103b of the elastic plug body 103 are both flat surfaces. It has become.

(Puncture needle holding force test)
The medical caps obtained in the examples and comparative examples were sterilized at 106 ° C. for 25 minutes using an autoclave. Forty samples of such medical caps were prepared, and the holding force when each of the metal needle (16G metal needle) and the resin needle (400 resin needle) was stabbed into the elastic stopper 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 106 ° C. for 25 minutes using an autoclave. Next, each medical cap was attached to a test pressure can body, and a connection tube (trade name: 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 specimens was 200.

  Next, each medical cap sterilized in the same manner as described above is attached to a test pressure can body, and an infusion set (trade name; TK-A400LK) manufactured by Terumo Corporation is punctured at the drip site and left for 4 hours. did. Thereafter, the needle was removed and checked for liquid leakage. The number of specimens 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 Tables 2 and 3 below. The number of specimens was 200.

It is a manufacturing method of the medical cap which concerns on one Embodiment of this invention, Comprising: It is sectional drawing showing a mode that the elastic stopper was mounted on the 1st ring-shaped projection part of a lower mold. FIG. 5 is an enlarged view schematically showing the shape of the tip of a second ring-shaped protrusion in the upper mold used in the manufacturing method. It is a perspective view which shows schematically the upper metal mold | die used for the said manufacturing method. It is a schematic diagram showing the relationship between the outer diameter of the 1st ring-shaped projection part of a lower mold used in the manufacturing method of the medical cap, and the 2nd ring-shaped projection part of an upper mold. It is a schematic diagram showing the relationship between the height of the 1st ring-shaped projection part of the lower metal mold | die used with the manufacturing method of the said medical cap, and the height of the 2nd ring-shaped projection part of an upper metal mold | die. It is a schematic diagram showing the relationship between the width | variety of the 1st ring-shaped projection part of the lower mold | type used by the manufacturing method of the said medical cap, and the width | variety of the 2nd ring-shaped projection part of an upper mold | type. It is a perspective view which shows roughly the lower metal mold | die used for the said manufacturing method. It is sectional drawing showing a mode that the upper metal mold | die and the lower metal mold | die were closed in the said manufacturing method. It is sectional drawing showing a mode that the upper metal mold | die and the lower metal mold | die were opened in the said manufacturing method. It is sectional drawing which shows typically the medical cap which concerns on this Embodiment. It is sectional drawing which shows the various elastic stoppers used for the said medical cap. It is sectional drawing which shows typically the medical cap which concerns on Example 2 of this invention. It is sectional drawing which shows the medical cap which concerns on the comparative example 1 typically.

Explanation of symbols

DESCRIPTION OF SYMBOLS 11 Upper metal mold | die 11a Press part 11b 2nd ring-shaped projection part 12 Lower mold | die 12a 1st ring-shaped projection part 13 Elastic plug 13a Upper surface (needle stick surface)
13b Bottom surface (wetted surface)
13c Side peripheral part 13d Step part 14 Cavity 15 Outer frame body 29 Peel film 29a Affixing part 30, 31 Medical cap 41 Elastic plug body 41a Needle stick surface 41b Liquid contact surface 41c Step part 42 Elastic plug body 42a Needle stick surface 42b Contact Liquid surface 43 Elastic plug body 43a Needle piercing surface 43b Liquid contact surface 43c Annular groove 43d Stepped portion 44 Elastic plug body 44a Needle piercing surface 44b Liquid contact surface 44c Projection portion 44d Stepped portion 45 Elastic plug body 45a Needle piercing surface 45b Liquid contact Surface 45c Stepped part

Claims (7)

A method for producing a medical cap having an elastic plug and an outer frame that holds the side peripheral portion thereof with an inner wall,
A lower mold having a first ring-shaped protrusion having an outer diameter smaller than the diameter of the elastic plug;
An upper mold having a second ring-shaped protrusion having an outer diameter smaller than the diameter of the elastic plug,
Placing the elastic plug on the first ring-shaped protrusion of the lower mold;
By closing the upper mold and the lower mold, the peripheral edge of the elastic plug body is pressed from above and below by the first ring-shaped protrusion and the second ring-shaped protrusion. Forming a cavity for molding,
A method for manufacturing a medical cap, wherein the outer frame body is formed by injecting molten resin into the cavity. The inner height of the first ring-shaped protrusion in the lower mold is higher than the inner height of the second ring-shaped protrusion in the upper mold,
The method for producing a medical cap according to claim 1, wherein when the upper mold and the lower mold are closed, the lower surface of the elastic plug body is in a state of bulging more convexly than the upper surface. A medical cap obtained by the method for producing a medical cap according to claim 1 or 2,
The elastic plug is fused at the contact surface with the outer frame,
A medical cap in which at least the lower surface of the elastic plug is a convex surface that bulges downward toward the lower side.   The outer frame body has a sticking portion to which a peel film for sealing the elastic plug body can be attached, and when the peel film is detachably attached to the sticking portion, The medical cap according to claim 3 which does not contact.   The medical cap according to claim 4, wherein the lower surface of the elastic plug body is a convex surface that bulges more convexly than the upper surface.   The medical cap according to any one of claims 3 to 5, wherein the elastic plug body includes a thermoplastic elastomer. It is a medical bottle which has a bottle main body which accommodates a chemical | medical solution, and an extraction part which takes out a chemical | medical solution with a needle | hook, Comprising: The said extraction part is a medical cap in any one of Claims 3-6 characterized by the above-mentioned. And medical bottle.

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