JP2011036429A - Medical cap, and method for manufacturing the same - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a medical cap, a method for manufacturing the same, and a medical container with the medical cap, having excellent tight adhesion performance between a rubber plug and an outer frame member to hold its circumferential edge part with inner wall, causing no positional displacement between the rubber plug and outer frame member due to puncture, and having excellent security of seal performance. <P>SOLUTION: The medical cap includes the rubber plug, and the outer frame member to hold its side circumferential part with the inner wall. At the circumferential edge part of the rubber plug on the fluid contact surface side, a surface to get in contact with the outer frame member is fused by heat fusion. In addition, by pressure from the outer frame member, the fluid contact surface is held in a recessed state toward its center. <P>COPYRIGHT: (C)2011,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.

  Unlike infusion, the replenisher used in the treatment with an artificial kidney is used continuously for a long time by connecting a large-capacity medical container. For this reason, the performance required for medical containers is also evaluated under severe conditions. For example, it is required that three bottle needles are stabbed at the same time, left for 24 hours and then withdrawn to prevent liquid leakage.

  As such a medical container, for example, a medical bag containing a medical solution or the like provided with a medical cap capable of taking out the chemical solution or the like with a bottle needle or an injection needle is used. Further, as the medical cap, a cap provided with a plug made of an elastomer resin for needle stick inside the outer frame is used.

  However, in the case of a conventional medical cap using a plug made of an elastomer resin, when a large-capacity medical container as described above is connected and used continuously for a long time, the liquid is removed from the medical cap. There is a problem of leakage.

JP-A-2005-118185

  The present invention has been made in view of the above-mentioned problems, and the object thereof is excellent in adhesion between the rubber plug and the outer frame body holding the peripheral edge portion thereof by the inner wall, and the positions of the rubber plug and the outer frame body by needle sticking. An object of the present invention is to provide a medical cap that has no deviation and is excellent in ensuring hermeticity, a manufacturing method thereof, and a medical container including the medical cap.

  The inventors of the present application have studied a medical cap, a method for manufacturing the same, and the medical cap in order to solve the conventional problems. As a result, the inventors have found that the object can be achieved by adopting the following configuration, and have completed the present invention.

  That is, the medical cap according to the present invention is a medical cap having a rubber plug and an outer frame body that holds a side peripheral portion thereof with an inner wall in order to solve the above-described problems. In the peripheral part on the liquid contact surface side in this, the surface that contacts the outer frame body is fused by heat melting, and the liquid contact surface is It is characterized by being held in a concave state toward the center.

  With the above-described configuration, the rubber plug is pressed from the outer frame at the peripheral portion of the wetted surface of the rubber plug, so that the rubber plug is in a state where compressive stress (caulking force) is applied from the peripheral portion toward the center. ing. As a result, the wetted surface is concave toward the center. Moreover, the surface which contacts an outer frame body is melt | fused in the peripheral part by the side of the liquid-contact surface in a rubber stopper. As a result, in the medical cap having the above-described configuration, the adhesion between the rubber stopper and the inner wall of the outer frame body is improved in each step at the peripheral portion on the liquid contact surface side, and the holding force against needle removal is increased. In addition, the resilience is excellent, and the resealability after needle removal can be improved. The “fusion” means that the surface of the rubber plug is softened by the molten resin coming into contact with the rubber plug when the outer frame body is molded, and is melted onto the fine uneven surface of such a rubber plug. It means that the resin is in close contact with the infiltrated state. The “needle puncture surface” means that the medical cap of the present invention is attached to a medical container that contains a chemical solution or the like, and when taking out the chemical solution or the like, a needle plug by a bottle needle or an injection needle is used in a rubber stopper. Means the surface where The “wetted surface” means a surface in contact with a chemical solution or the like in a rubber stopper.

  Here, a laminate film that melts heat is provided on the wetted surface of the rubber plug, and the surface in contact with the outer frame body at the peripheral portion on the wetted surface side of the rubber plug is the surface of the rubber plug. It is preferable that the laminate film is fused by heat melting.

  With the above configuration, the surface in contact with the outer frame body is fused by the laminate film at the peripheral portion on the liquid contact surface side of the rubber plug. As a result, in the case of the medical cap having the above-described configuration, the adhesion between the rubber stopper and the inner wall of the outer frame body is improved in each step at the peripheral portion on the liquid contact surface side, so that the needle cap can be retained. It has excellent force and restoring force, and can improve resealability after needle removal.

  A medical cap manufacturing method according to the present invention is a method for manufacturing a medical cap having a rubber plug and an outer frame body that holds a side peripheral portion thereof with an inner wall in order to solve the above-described problems, A first mold having a first ring-shaped protrusion having an outer diameter smaller than the diameter of the rubber plug; and a second mold having a second ring-shaped protrusion having an outer diameter smaller than the diameter of the rubber plug. Preparing, placing the rubber stopper on the first ring-shaped protrusion of the first mold, and closing the first mold and the second mold, thereby allowing the first ring-shaped protrusion and A cavity for molding the outer frame body is formed with the second ring-shaped protrusion pressing the peripheral edge of the rubber stopper from above and below, and the outer frame body is molded by injecting molten resin into the cavity. It is characterized by doing.

  According to the above method, when the outer frame body is molded, the peripheral part of the rubber plug is moved up and down by the first ring-shaped protrusion part of the first mold and the second ring-shaped protrusion part of the second mold. It is performed in a state where it is pressed. As a result, the rubber plug is subjected to a compressive stress (caulking force) from the peripheral edge toward the center, and either one surface of the rubber plug becomes concave toward the center. Thereby, the adhesiveness of a rubber stopper and an outer frame can be improved. Further, when the outer frame body is molded, since the resin constituting the outer frame body is injected into the cavity in a state of being melted by heat, the surface of the rubber stopper touching the molten resin is heated and softened. Further, the molten resin penetrates into the fine uneven surface of the softened rubber stopper, and thereby the outer frame body is molded in a state of being in close contact with the rubber stopper (that is, in a fused state). As a result, the adhesion between the rubber stopper and the inner wall of the outer frame body is improved in each step at the peripheral part on the wetted surface side, and it has excellent holding force and restoring force against needle removal, and reseals after needle removal. A medical cap with improved properties can be obtained.

  In the above method, the rubber plug is provided with a laminate film that can be melted by heat on its wetted surface, and the outer peripheral portion of the rubber plug on the wetted surface side is used. It is preferable that the surface in contact with the frame is fused by thermally melting the laminate film.

  According to the above method, when the outer frame body is molded, since the resin constituting the outer frame body is injected into the cavity in a melted state due to heat, the laminated film of the rubber stopper that has come into contact with the molten resin is melted by heat. . As a result, at the interface between the laminate film and the outer frame body, the polymer chains in the two polymer resins are intertwined and firmly bonded (that is, fused), and the outer frame body is Molding is performed. As a result, the adhesion between the rubber stopper and the inner wall of the outer frame body is improved in each step at the peripheral part on the wetted surface side, and the holding force and restoring force against needle removal are excellent. A medical cap with improved properties can be obtained.

  The medical container according to the present invention is a medical container having at least a main body for storing a chemical solution and an extraction portion for taking out the chemical solution with a needle. It is a medical cap as described.

It is a manufacturing method of the medical cap which concerns on one Embodiment of this invention, Comprising: The same figure (a) represents a mode that the rubber stopper was inserted in the 1st metal mold | die, (b) the 1st metal mold | die. FIG. 2C is a cross-sectional view showing a state in which the first mold and the second mold are opened. FIG. 4A shows a state where a rubber stopper is inserted into the first mold in the method for manufacturing a medical cap according to the embodiment, and FIG. 4B shows a conventional medical cap. It is explanatory drawing showing a mode that the rubber stopper was inserted in the lower metal mold | die in this manufacturing method. It is a perspective view which shows schematically the 1st metal mold | die used for the said manufacturing method. It is a perspective view which shows the 2nd metal mold | die used for the said manufacturing method roughly. FIG. 4 is an enlarged view schematically showing the shape of the tip of a ring-shaped protrusion in the first mold and the second mold. It is sectional drawing which shows the various rubber stoppers used for the said medical cap. It is sectional drawing showing the medical cap which concerns on one Embodiment of this invention. It is explanatory drawing which represents typically the medical container which applied the said medical cap to the extraction part of a chemical | medical solution. It is sectional drawing showing the medical cap which concerns on other embodiment of this invention.

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

  The medical cap according to the present embodiment has a structure having an outer frame body including a rubber plug and an outer frame body that holds a side peripheral portion of the rubber plug with an inner wall.

  The outer frame body is molded by, for example, injection molding using the first mold 11 and the second mold 18. That is, the rubber plug 13 is placed inside the first mold 11 so that the needle stick surface (upper surface) 13a faces downward (see FIG. 1A).

  As the rubber plug 13, a rubber plug having a laminated film on the liquid contact surface 13b of the rubber plug can be used. Thereby, the surface which contacts an outer frame body in the peripheral part by the side of the liquid-contact surface 13b in the rubber plug 13 is fuse | fused with a laminate film. As a result, the adhesion between the rubber stopper 13 and the inner wall of the outer frame body is improved in each step at the peripheral edge on the liquid contact surface 13b side, and the holding force and restoring force against needle removal, and re-adhesion after needle removal. The sealing performance can be further improved.

  Moreover, you may use the rubber plug 13 in which the laminated film is not provided in the liquid-contact surface 13b. In this case, an increase in manufacturing cost for laminating the liquid contact surface 13b of the rubber plug 13 can be suppressed. Moreover, in the rubber stopper which laminated the laminate film on the liquid contact surface 13b, when the bottle needle or the injection needle is punctured into the puncture part, the laminate film is torn and is smaller than the hole diameter of the bottle needle or the like called a fragment. Fine rubber pieces and film pieces (coring) may occur. However, when the laminate film is not used, there is no generation of rubber pieces due to the film being used as a substitute for the plate, and there is no generation of film pieces. Furthermore, it is difficult to produce a thin laminate film that does not impair rubber elasticity, but in this case there is no such problem.

  The rubber stopper 13 has a cylindrical structure in which the needle stick surface 13a and the liquid contact surface 13b are flat. However, the rubber plug of the present invention is not limited to the shape described above. Moreover, the diameter of the rubber plug 13 is not specifically limited, Usually, it sets within the range of 10-40 mm. The thickness T of the rubber plug 13 is not particularly limited, and is usually set within a range of 3 to 15 mm. Other aspects of the rubber plug 13 will be described in detail later.

  Next, the first mold 11 and the second mold 18 are closed (see FIG. 1B). At this time, the cavity 20 capable of forming the outer frame is formed. The first mold 11 includes a first ring-shaped protrusion 11 a having an outer diameter smaller than the diameter of the needle piercing surface 13 a of the rubber plug 13. The second mold 18 includes a second ring-shaped protrusion 18 a having an outer diameter smaller than the diameter of the liquid contact surface 13 b of the rubber plug 13. When the mold is closed, a gap is formed on the needle piercing surface 13a side of the rubber stopper 13, so that the needle piercing surface 13a is pressed by the second ring-shaped protrusion 18a and pushed upward. . Further, the liquid contact surface 13b side of the rubber plug 13 is also recessed in a concave shape by the second ring-shaped protrusion 18a. Further, the side peripheral portion 13c of the rubber plug is also depressed.

  Here, the first ring-shaped protrusion 11a of the first mold 11 is, for example, one continuous ring-shaped protrusion as shown in FIG. However, the present invention is not limited to this. For example, as shown in FIG. 3B, a plurality of pins having a uniform height are set up on the circumference, and the first ring-shaped protrusion 11a ′ as a whole. 1st metal mold | die 11 'which forms may be sufficient.

The outer diameter d ₁ of the first ring-shaped protrusion 11a can press the peripheral portions of the at Haritogemen 13a in the rubber plug 13 is not particularly limited smaller than its diameter, the shape of the rubber plug 13 to be inserted, It can be set appropriately according to the size. The diameter of the needle puncturing surface 13a and _{s 1,} and, if used as a reference it is preferably the outer diameter _{d 1} is in the range of _{(s 1 -20) ~ (s} 1 -0.2) mm , (S ₁ −15) to (s ₁ −0.4) mm is more preferable. When d1 exceeds (s ₁ −0.2) mm, the end of the needle piercing surface 13a of the rubber plug 13 enters the inside of the first ring-shaped protruding portion 11a during mold clamping, so that, for example, rubber In some cases, the stopper 13 is molded in a distorted state such as being held biased to one side. On the other hand, when d ₁ is less than (s ₁ -20) mm, the deformation of the rubber plug 13 due to the pressing of the first ring-shaped protrusion 11a is directed to the outside rather than the inside of the first ring-shaped protrusion 11a. As a result, there is a case where it is difficult to close the mold because there is no allowance for deformation of the rubber plug. Incidentally, wherein _{s 1} is not particularly limited and is usually set within the range of 5 to 35 mm. However, when the rubber stopper does not have a stepped portion, the diameter s _{1 of the} needle piercing surface 13a matches the diameter of the rubber stopper. Accordingly, d _{1 in} such a case is set within a numerical range of the diameter of the rubber stopper described later.

  Here, the second ring-shaped protrusion 18a of the second mold 18 is, for example, one continuous ring-shaped protrusion as shown in FIG. However, the present invention is not limited to this. For example, as shown in FIG. 4B, a plurality of pins having the same height are set up on the circumference, and the second ring-shaped protrusion 18a ′ is formed as a whole. It may be a second mold 18 ′ for forming

The outer diameter d ₂ of the second ring-shaped projecting portion 18a can press the peripheral portions of the at wetted surface 13b on the rubber plug 13 is not particularly limited smaller than its diameter, the shape of the rubber plug 13 to be inserted, It can be set appropriately according to the size. When the diameter of the liquid contact surface 13b is s ₂ and this is used as a reference, the outer diameter d ₂ is preferably in the range of (s ₂ −20) to (s ₂ −0.2) mm. , (S ₂ −15) to (s ₂ −0.4) mm is more preferable. When d ₂ exceeds (s ₂ −0.2) mm, the end of the wetted surface 13b of the rubber plug 13 enters the inside of the second ring-shaped projecting portion 18a during mold clamping. In some cases, the rubber plug 13 is molded in a distorted state such as being held biased to one side. On the other hand, when d ₂ is less than (s ₂ −20) mm, the deformation of the rubber plug 13 due to the pressing of the second ring-shaped protrusion 18a is directed toward the outside rather than the inside of the second ring-shaped protrusion 18a. As a result, there is a case where it is difficult to close the mold because there is no allowance for deformation of the rubber plug. Note that the _{s 2} is not particularly limited and is usually set within the range of 5 to 35 mm. However, if the rubber plug is no stepped portion, the diameter s ₂ of wetted surface 13b coincides with the diameter of the rubber stopper. Accordingly, d _{2 in} such a case is set within a numerical range of the diameter of the rubber stopper described later.

  The front ends of the first ring-shaped protrusion 11a and the second ring-shaped protrusion 18a are flat surfaces as shown in FIG. 5 (a), and the surface is formed by electric discharge machining or the like as shown in FIG. 5 (b). It may have a shape with increased roughness or a shape having a minute protrusion at its tip as shown in FIG. Moreover, as shown to the same figure (d), uneven | corrugated shape may be sufficient. With these shapes, the first ring-shaped protrusion 11a securely grips the needle puncture surface 13a of the rubber plug 13, and the second ring-shaped protrusion 18a securely grips the liquid contact surface 13b of the rubber plug 13. The rubber plug 13 can be pressed in the state.

The height h ₁ of the first ring-shaped protrusion 11a may be appropriately set according to the thickness or the like of the rubber plug 13. Usually, it is preferably within a range of 0.1 to 3 mm, for example, and more preferably within a range of 0.2 to 1.5 mm. If h ₁ is less than 0.1 mm, the peripheral edge portion of the needle stab surface 13a of the rubber plug 13 may not be sufficiently pressed. On the other hand, when h ₁ exceeds 3 mm, the peripheral edge is excessively pressed, and the needle piercing surface 13a of the rubber plug 13 is distorted. Further, there is a problem that the clamping of the first mold 11 and the second mold 18 is insufficient. The height h ₁ of the first ring-shaped protrusion 11a is based on the lower mold 33 used when the outer frame body is molded without applying compressive stress (caulking force) to the rubber plug 13. (See FIG. 2). That is, the lower mold 33 is provided with a mounting portion 34 for mounting the rubber plug 13. When the height h ₅ of the mounting portion 34 is used as a reference, the h ₁ is relative to h _5. It is high within a range of 0.1 to 3 mm.

Further, in the height h ₂ is the inside of the first ring-shaped protrusion 11a, it may be set larger than the outer height h _1. Usually, it is preferably within a range of 0.5 to 5 mm, for example, and more preferably within a range of 1 to 3 mm. When the _{h 2} is less than 0.5 mm, it may not be sufficiently pressed periphery of Haritogemen 13a of the rubber plug 13. On the other hand, when h ₂ is greater than 5 mm, pressing is excessive for the periphery of Haritogemen 13a of the rubber plug 13, there is a case where the cap is deformed. In the present embodiment, the height h ₁ on the outer side of the first ring-shaped protrusion 11a and the height h ₂ on the inner side may be the same, but the height of the first ring-shaped protrusion 11a may be the same. If you increase the inside of the height h _2, it is possible to improve the squeezing effect against the rubber stopper 13.

The height h ₃ of the second ring-shaped projections 18a can be set appropriately in accordance with the thickness and the like of the rubber plug 13. Usually, it is preferably within a range of 0.1 to 3 mm, for example, and more preferably within a range of 0.2 to 1.5 mm. When the h ₃ is less than 0.1 mm, it may not be possible to sufficiently press the at periphery to the wetted surface 13b of the rubber plug 13. On the other hand, when h3 exceeds ₃ mm, the pressure against the peripheral portion becomes excessive, and the liquid contact surface 13b of the rubber plug 13 becomes distorted. Further, there is a problem that the clamping of the first mold 11 and the second mold 18 is insufficient. The height h ₃ of the second ring-shaped protrusion 18a is the upper mold 35 to be used when performing molding of the outer frame member with no added compressive stress (crimping force) of the rubber stopper 13 as a reference (See FIG. 2). That is, the upper mold 35 is provided with a base portion 36 for preventing molten resin as a constituent material of the outer frame body from flowing out at a portion other than the peripheral portion of the rubber plug 13. When the height h ₆ of the portion 36 is used as a reference, the h ₃ is higher than the h ₆ within a range of 0.1 to ₃ mm.

Further, the height h ₄ on the inner side of the second ring-shaped protrusion 18 a can be set to be larger than the outer height h ₃ . Usually, it is preferably within a range of 0.5 to 5 mm, for example, and more preferably within a range of 1 to 3 mm. When the _{h 4} is less than 0.5 mm, it may not be sufficiently pressed periphery of wetted surface 13b of the rubber plug 13. On the other hand, if h ₄ exceeds 5 mm, pressing is excessive for the periphery of the wetted surface 13b of the rubber plug 13, cap or deformed, there is a case where the laminate film is damaged. In the present embodiment, the height h ₃ on the outer side of the second ring-shaped protrusion 18 a and the height h ₄ on the inner side may be the same, but the second ring-shaped protrusion 18 a If you increase the inside of the height h _4, it is possible to improve the squeezing effect against the rubber stopper 13.

Here, the shape, position, and size of the first ring-shaped protrusion 11a and the second ring-shaped protrusion 18a are not particularly limited, and various combinations are possible within the above numerical range. For example, the outer diameter d ₁ of the first ring-shaped protrusion 11a, an outer diameter d ₂ is the same of the second ring-shaped projections 18a, and has a first mold 11 and second mold 18 mold closing and In some cases, the positions of the two may coincide. Also, well outside diameter d ₂ of the second ring-shaped protrusion portion 18a even greater aspect than the outer diameter d ₁ of the first ring-shaped projections 11a, on the contrary, outside of the first ring-shaped protrusion 11a diameter _{d 1} may be a greater manner than the outer diameter _{d 2} of the second ring-shaped protrusion 18a.

As for the height of the first ring-shaped protrusion 11a and the second ring-shaped projections 18a, the height _{h 1} of the first ring-shaped protrusion 11a, the second ring-shaped protrusion 18a height _{h 2} It may be the same. Further, the height h _{1 of} the first ring-shaped protrusion 11a may be larger than the height h _{2 of} the second ring-shaped protrusion 18a, and conversely, it may be greater aspect than the height h ₂ is the height h ₁ of the first ring-shaped protrusion 11a. In FIG. 1, the case where the 2nd ring-shaped projection part 18a is larger than the 1st ring-shaped projection part 11a is shown.

Regarding the width of the first ring-shaped protrusion 11a and the second ring-shaped projections 18a, the width _{w 1} of the first ring-shaped projections 11a, narrower than the width _{w 2} of the second ring-shaped protrusion 18a May be. Furthermore, the width w ₁ of the first ring-shaped projections 11a, may be the same in the state in both widely state the width w ₂ of the second ring-shaped projections 18a, or that narrow the. Further, the width w ₂ of the second ring-shaped projections 18a, or may be narrower manner than the width w ₁ of the first ring-shaped protrusion 11a.

The width w ₁ of the first ring-shaped protrusion 11a 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. Meanwhile, the width _{w 2} of the second ring-shaped projections 18a, for example preferably in the range of 0.2～3.5Mm, and more preferably in a range of 0.3 to 2.5 mm.

  Next, a molten resin obtained by melting a resin as a constituent material of the outer frame body is injected into the cavity 20 formed by mold closing. At this time, the surface of the rubber plug 13 is softened by the heat of the molten resin. Further, the molten resin penetrates into the fine uneven surface of the softened rubber stopper. Thereafter, when the molten resin is cooled for a predetermined time, the outer frame body is molded in a state of being in close contact with the rubber plug 13 without gaps (that is, in a fused state). The degree of fusion varies depending on the molding conditions of the outer frame and the like. For example, as compared with the case of using a rubber plug 13 having a laminate film that can be melted by heat, the rubber plug 13 is applied when stress is applied. And the outer frame body 21 are separated from each other. Moreover, when the laminated film is provided in the liquid-contacting surface 13b side of the rubber stopper 13, the said laminated film is heat-melted with the heat | fever which molten resin has. After that, when the molten resin is cooled for a predetermined time, the polymer chains in the two polymer resins constituting them are intertwined and bonded at the contact surface between the laminate film and the outer frame. To do. The degree of fusion varies depending on the molding conditions of the outer frame. Therefore, for example, the case where the outer frame body is fused to the extent that the outer frame body is separated even on the liquid contact surface 13b side of the rubber plug 13 by applying stress is included.

  The temperature of the molten resin should be such that when a rubber plug and a laminated film are provided on the liquid contact surface 13b side, the molten resin is fused with the laminated film and is molded integrally with the outer frame body 21. For example, it is preferably within a range of 160 to 250 ° C, and more preferably within a range of 170 to 240 ° C. In addition, it does not specifically limit as injection pressure, It can set as needed suitably.

  After the mold opening, as shown in FIG. 1 (c), the outer frame body 21 is molded, and the medical cap 10 according to the present embodiment is obtained.

  The laminate film provided on the liquid contact surface 13b of the rubber plug 13 is not particularly limited, and a film that can be fused with the outer frame body 21 made of the synthetic resin is used. Specifically, for example, a plastic film whose main component is a fluororesin, polyethylene, polypropylene, polyester, ethylene vinyl acetate resin, or a mixture thereof can be used. However, the material of the laminate film is preferably selected in consideration of ease of fusion with the outer frame body 21.

  The manufacturing method of the rubber plug 13 is not particularly limited, and can be manufactured by a conventionally known method. Moreover, as a method of forming a laminate film on the liquid contact surface 13b of the rubber plug 13, for example, a method of forming a laminate film at the same time as the rubber plug 13 is formed may be mentioned. The conditions in this case are not particularly limited and can be set as appropriate.

  The material used for the rubber plug 13 is not particularly limited, and examples thereof include natural rubber, butyl rubber, isoprene rubber, butadiene rubber, and styrene-butadiene rubber. When the butyl rubber is used, the gas barrier property of the medical cap can be improved. In addition, when a material such as natural rubber is excellent in rubber elasticity, when a bottle needle or injection needle is inserted, a fine rubber piece having a diameter smaller than the hole diameter of the bottle needle or the like called a fragment is generated (coring ) Can be reduced. In addition, when the laminated film is provided in the liquid-contacting surface 13b side, the fall of gas barrier property can be prevented.

  Moreover, it does not specifically limit as a shape of the rubber plug used by this invention, It can change suitably as needed. For example, as shown in FIG. 6A, an annular rib 40d is provided on the needle puncture surface 40a side to be fitted with an annular groove provided on the outer frame body, and is provided on the outer frame body on the liquid contact surface 40b side. The rubber plug 40 may be provided with an annular groove 40e to be fitted with the annular rib. The annular rib 40d makes it possible to prevent deformation of the rubber stopper at the time of puncturing, and the annular groove 40e makes it possible to prevent the dropout. Further, as shown in FIG. 6B, the needle piercing surface 41a has a flat surface, and the liquid contact surface 41b includes an annular groove 41d fitted with an annular rib provided on the outer frame body. 41 may be sufficient. Moreover, as shown in FIG.6 (c), the rubber stopper 42 by which level | step-difference part 42d, 42e for drop-off prevention was provided in both the needle puncture surface 42a and the liquid-contact surface 42b is mentioned. Moreover, as shown in FIG.6 (d), the level | step-difference part 43d may be provided only in the needle puncture surface 43a, and the flat rubber stopper 43 may be sufficient as the liquid-contact surface 43b. Further, as shown in FIG. 6 (e), the needle puncture surface 44a is provided with an annular groove 44d that fits with an annular rib provided on the outer frame body, and the liquid contact surface 44b is also provided on the outer frame body. The rubber plug 44 may include an annular groove 44e that fits with the annular rib. Further, as shown in FIG. 6 (f), an annular groove 45d that fits with an annular rib provided on the outer frame body is provided on the side of the needle puncture surface 45a, and a step portion for preventing dropout on the liquid contact surface 45b side. The rubber stopper 45 provided with 45e may be sufficient. The annular groove 45d makes it possible to prevent deformation of the rubber stopper 13 during puncturing. Further, as shown in FIG. 6 (g), an annular rib 46d fitted to an annular groove provided in the outer frame body is provided on the needle puncture surface 46a side, and a stepped portion for preventing dropout is provided on the liquid contact surface 46b side. The rubber plug 46 provided with 46e may be sufficient.

  Moreover, as a material which comprises the said outer frame body 21, the safety | security for medical use among the synthetic resins is sufficient. Of these, a thermoplastic resin is generally used. Specifically, resins conventionally used for medical use such as polyethylene, polypropylene, and polyvinyl chloride are preferable, but are not limited thereto.

  In the medical cap 10 obtained by the manufacturing method of the present embodiment, the needle puncture surface 13a is in a state of bulging in a convex shape toward the center (see FIG. 7). On the other hand, since the liquid contact surface 13b of the rubber plug 13 receives compressive stress from the fusion surface of the outer frame body 21 at the peripheral edge portion 15, the central portion is recessed in a concave shape. This is because the height of the second ring-shaped protrusion 18a of the second mold 18 is higher than that of the first ring-shaped protrusion 11a of the first mold. Thereby, the medical cap 10 according to the present embodiment can improve the holding force and the restoring force against needle removal, and can be excellent in resealability after needle removal. If the outer frame body is molded under the same conditions, the center part on the liquid contact surface side of the plug body swells in a convex shape if the plug body is made of a thermoplastic elastomer resin instead of a rubber plug. It becomes. This is because when the molten resin forming the outer frame body is injected into the cavities of the first mold and the second mold, the heat of the molten resin is applied to the peripheral portion on the liquid contact surface side of the plug body. It can be inferred that by softening, the compressive stress is relaxed only at the peripheral portion and the direction of the stress is changed.

  The medical cap 10 of the present invention obtained as described above is, for example, as shown in FIG. 8, in a medical container 50 having at least a main body 51 for storing a chemical solution and an extraction portion 52 for taking out the chemical solution with a needle. And can be applied to the extraction unit 52. In this case, the medical container 50 is connected to each other by the connecting tube 53 connected to the take-out portion 52, and the chemical solution can be continuously supplied for a long time. When the medical containers 50 are connected by such a method, it becomes possible to simultaneously consume the drug solutions in all the medical containers in parallel. Each connecting tube 53 is provided with a needle, and is pierced into the needle puncture surface 13 a of the rubber stopper in the medical cap 10 of the extraction portion 52. Furthermore, a chemical liquid extraction tube 54 is attached to any one of the plurality of medical containers 50. The drug solution extraction tube 54 is provided with a needle, and is punctured on the needle puncture surface 13 a of the rubber cap of the medical cap 10. The medical cap of the present invention prevents liquid leakage even when continuously used in such a mode of use, and has excellent retention force and restoring force against needle removal, and resealability after needle removal. It is good.

(Other matters)
The present invention is not limited to the embodiment described above, and various modifications can be made within the scope of the effects of the present invention. For example, in the above description, the structure in which the outer frame body has a flange has been described as an example, but the present invention is not limited to this aspect. For example, like the medical cap 30 shown in FIG. 9, the medical cap 30 provided with the outer frame 31 which does not have a flange may be sufficient. Even in the medical cap 30 having such a structure, the adhesion between the rubber stopper 13 and the inner wall of the outer frame body 31 is improved, so that the holding force and restoring force against needle removal are excellent, and resealing after needle removal is achieved. Can also be improved.

  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 those unless otherwise specified.

Example 1
In this example, the medical cap 10 shown in FIG. 7 was manufactured according to the method shown in FIG. Polypropylene was used as the material of the outer frame 21, and isoprene rubber was used as the material of the rubber plug 13. As a molding machine, an injection molding machine (trade name; NS60-9A) manufactured by Nissei Plastic Industry Co., Ltd. was used.

The shape of the rubber plug is as follows.
Diameter of rubber stopper (needle stick surface and wetted surface): 20mm
Thickness T: 7mm

The shape dimensions of the first ring-shaped protrusion are as follows.
Outside height h ₁ : 0.3 mm
Inner height h ₂ : 1.2 mm
Width w ₁ : 1.3 mm
Outer diameter d ₁ : 18 mm
Tip shape: Plain

The shape dimensions of the second ring-shaped protrusion are as follows.
Outside height h ₃ : 0.5 mm
Inner height h ₄ : 1.4 mm
Width _w 2: 0.5mm
Outer diameter d ₂ : 16 mm
Tip shape: Plain

The molding conditions for the outer frame are as follows.
Injection molding temperature: 230 ° C
Injection pressure: 4.2 MPa
Injection time: 3.0 seconds First mold temperature and second mold temperature: 43 ° C

(Example 2)
In this example, a medical cap according to this example was produced in the same manner as in Example 1 except that a rubber plug having a laminated film made of polypropylene on the wetted surface was used. .

(Comparative Example 1)
In this comparative example, the present embodiment is the same as the first embodiment except that the lower mold 33 and the upper mold 35 shown in FIG. 2B are used as the molds for forming the outer frame. A medical cap according to a comparative example was produced.

(Comparative Example 2)
In the present comparative example, the present embodiment is the same as the second embodiment except that the lower mold 33 and the upper mold 35 shown in FIG. 2B are used as the mold used for forming the outer frame. A medical cap according to a comparative example was produced.

(Comparative Example 3)
In this comparative example, a medical cap according to this comparative example was produced in the same manner as in Example 1 except that a plug made of a styrene thermoplastic elastomer was used instead of the rubber plug.

(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 the metal needle (16G metal needle) and the resin needle (400 resin needle) were respectively inserted into the rubber stopper or the stopper was examined. Each medical cap was pulled and set in a compression tester, and the following puncture needle attached to the tester was punctured vertically in the center of the rubber stopper or stopper, and then the puncture needle was moved at a speed of 200 mm / min. The force (unit; N) when the puncture needle was pulled out from the rubber stopper or 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. The results are shown in Table 2 below.

  Next, each medical cap sterilized in the same manner as described above is attached to a 2 L bag containing 2 L of water, and a connecting pipe (trade name: 15-D12) manufactured by Nipro Co., Ltd. is attached to the needle stick site. This was punctured. In this state, after leaving for 24 hours, the needle was removed and the amount of liquid leakage at that time was measured. The number of specimens was 200. The results are shown in Tables 2 and 3 below.

DESCRIPTION OF SYMBOLS 10, 30 Medical cap 11 1st metal mold | die 11a 1st ring-shaped projection part 13, 40-46 Rubber stopper 13a, 40a-46a Needle stick surface 13b, 40b-46b Liquid contact surface 13c Side periphery 15 Peripheral part 18 1st 2 mold 18a 2nd ring-shaped projection part 20 cavity 21 outer frame body 40d, 46d annular rib 40e, 41d, 44d, 44e, 45d annular groove 42d, 42e, 43d, 45e, 46e step part 50 medical container 51 main body 52 Extraction part 53 Connecting tube 54 Chemical solution extracting tube

Claims (5)

A medical cap having a rubber stopper and an outer frame body that holds the side peripheral portion thereof with an inner wall,
In the peripheral portion on the liquid contact surface side of the rubber plug, the surface in contact with the outer frame body is fused by heat melting and is pressed from the outer frame body, thereby A medical cap in which the liquid level is held in a concave shape toward the center. The wetted surface of the rubber plug is provided with a laminate film that melts heat,
2. The medical cap according to claim 1, wherein a surface in contact with the outer frame body is fused by thermally melting the laminate film at a peripheral portion on the liquid contact surface side of the rubber plug. A method for producing a medical cap having a rubber stopper and an outer frame body that holds the side peripheral portion thereof with an inner wall,
A first mold having a first ring-shaped protrusion having an outer diameter smaller than the diameter of the rubber plug; and a second mold having a second ring-shaped protrusion having an outer diameter smaller than the diameter of the rubber plug. Prepare
Placing the rubber stopper on the first ring-shaped protrusion of the first mold;
By closing the first mold and the second mold, the outer frame body with the first ring-shaped protrusion and the second ring-shaped protrusion pressing the peripheral edge of the rubber stopper from above and below. 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. Using the rubber plug provided with a laminate film that can be melted by heat on its wetted surface,
The medical cap according to claim 3, wherein a surface in contact with the outer frame body is fused by thermally melting the laminate film at a peripheral portion of the rubber plug on the liquid contact surface side. Production method.   A medical container having at least a main body for storing a chemical solution and an extraction portion for extracting the chemical solution with a needle, wherein the extraction portion is the medical cap according to claim 1 or 2.

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