JP7274742B2 - Medical cap and manufacturing method thereof - Google Patents

Description

TECHNICAL FIELD The present invention relates to a medical cap used for drug containers such as infusion containers, blood collection tubes, vials and the like, and a method for producing the same. In particular, the present invention relates to a medical cap that does not leak liquid when punctured by a needle and has excellent holding power and restoring power against needle slippage, and a method for producing the same.

Drug containers used in the medical field, such as drug bottles and infusion bottles for infusion, have a rubber stopper as a cap or an elastic stopper inside the outer frame (for example, , rubber, elastomer resin, etc.) are used. In the latter cap, the outer frame is attached to the opening of the drug container by welding or the like. When in use, an injection needle equipped with a take-out tube is pierced into the elastic stopper, and the drug container is placed upward and the cap is placed downward to take out the infusion solution in the container through the take-out tube. In addition, such medical caps are required to have airtightness in order to prevent leakage of medical solutions and infusions and to prevent deterioration due to contact with air.

As the medical cap, for example, the liquid contact surface of the elastic plug and the upper portion of the bottom surface holding portion of the outer frame are fused together, and the side surface of the elastic plug is attached to the side circumference of the outer frame. A structure has been proposed in which the inner wall of the part is in contact with the inner wall in a non-fused state (see Patent Document 1 below). According to Patent Document 1, it is disclosed that the rubber properties are improved and the resealability can be improved.

However, with conventional medical caps, there are cases in which the elastic stopper and the outer frame are not in close contact with each other. In such a medical cap, when a needle is inserted into the cap, the positions of the elastic plug and the outer frame may be displaced and a gap may be formed between them. There is a problem that it becomes difficult to do.

In order to solve the above problem, Patent Document 2 below discloses a medical cap in which the liquid-contacting surface of the elastic plug has a convex slope toward the center of the circle. With this medical cap, since pressure is applied from the outer frame to the horizontal component of the elastic plug, it is possible to improve the resealability and prevent the needle from slipping out.

Further, in Patent Document 3 below, a thermoplastic elastomer having a hardness of 30 to 55 degrees and a compression set of 40% or less, and a ring-shaped or A joint plug for a chemical solution container made of a polyolefin resin that is integrally molded into a cylindrical shape is disclosed. Further, according to Patent Document 3, it is described that the sealing property is improved and the liquid medicine does not leak to the outside even when the bottle needle is pulled out.

However, even with the medical caps and the like disclosed in Patent Documents 2 and 3, there is a problem that prevention of liquid leakage and needle slip-out is insufficient.

JP 2005-118185 A JP-A-8-317961 Japanese Patent Application Laid-Open No. 2004-215860

SUMMARY OF THE INVENTION The present invention has been made in view of the above-mentioned problems, and an object thereof is to provide a medical cap having an elastic plug and an outer frame for holding the elastic plug inside. To provide a medical cap that prevents the occurrence of voids due to misalignment of a frame body, does not leak liquid at the time of needle sticking, has excellent holding power and restoring power against needle removal, and has excellent sealing performance, and a method for manufacturing the same. to do.

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

That is, in order to solve the above-described problems, the medical cap according to the present invention comprises an elastic plug, an upper frame supporting the peripheral edge of the elastic plug from the upper side, and a lower frame supporting the peripheral edge of the elastic plug from the lower side. an outer frame body having at least a portion, wherein the lower frame portion has an inner wall that surrounds and accommodates a plurality of the elastic plugs, and an outer wall that surrounds the inner wall. the upper frame portion has an annular wall that presses the inner wall and the elastic plug in the gap between the inner wall and the outer wall, and the inner wall is welded at the contact surface with the annular wall; Moreover, the annular wall is not welded to the elastic plug, and the annular wall is welded to the elastic plug in the gaps between the plurality of inner walls, and is welded to the contact surface of the outer wall. It is characterized by

According to the above configuration, the elastic plug is welded or closely attached to the annular wall of the upper frame in the gaps between the inner walls. Also, the elastic plug is in close contact with the inner walls. Furthermore, the annular wall has a structure in which a plurality of inner walls and an outer wall of the lower frame are welded together at their contact surfaces. Therefore, according to the above configuration, it is possible to prevent the occurrence of a gap due to the positional deviation between the elastic plug and the outer frame when the elastic plug is pierced with a needle. Furthermore, it is possible to prevent the occurrence of liquid leakage and to secure the airtightness.

The annular wall of the upper frame portion is located in the gap between the inner wall and the outer wall of the lower frame portion, and pressure is applied to the side peripheral surface of the elastic plug from the inner wall and the annular wall. Therefore, the holding force and restoring force against needle removal are extremely excellent, and the resealing property after needle removal is also good.

In the above configuration, a mounting portion for mounting the elastic plug body in the lower frame portion is provided with an annular ridge portion, and the annular ridge portion corresponds to the elastic plug. It may be implanted in the lower surface of the lateral periphery of the body. By embedding the annular protrusion in the lower surface of the side peripheral portion of the elastic plug, it is possible to further prevent the elastic plug from being dislocated or falling off.

In the above configuration, the upper surface of the elastic plug, or a portion of the upper and lower surfaces excluding the peripheral edge portion may be deformed into a convex shape. By deforming only the upper surface of the elastic plug into a convex shape, or by deforming both the upper and lower surfaces of the elastic plug into a convex shape, compressive stress (caulking force) is applied to the elastic plug, The elastic plug can be held inside the outer frame. As a result, it is possible to increase the holding force and restoring force against needle removal and improve the resealing property after needle removal.

Further, in the above configuration, the elastic plug has a stepped portion on the peripheral edge portion of its upper surface, and the upper frame portion has a pressing portion for pressing the stepped portion. is preferred. As a result, the elastic plug can be held inside the outer frame while a compressive stress (caulking force) is applied to the stepped portion of the elastic plug. As a result, it is possible to increase the holding force and restoring force against needle removal and improve the resealing property after needle removal.

In the above configuration, it is preferable that the height position of the outer wall is equal to or higher than the upper surface of the elastic plug. As a result, the contact surface with the outer wall is welded to the pressing portion, and the pressing portion can be held, and the compressive stress can be applied more efficiently to the peripheral edge portion and the stepped portion on the upper surface side of the elastic plug. can.

Furthermore, in the above configuration, it is preferable that the height position of the inner wall is equal to or higher than the height position of the side peripheral portion of the elastic plug and lower than the upper surface of the elastic plug. By setting the height position of the inner wall to be higher than the height position of the side circumference of the elastic plug, when the elastic plug is made of rubber or thermoplastic elastomer resin, the side circumference can extend in the height direction. In this case, it is possible to prevent the inner wall from not receiving a substantially uniform pressing force. Furthermore, when the elastic plug is made of a thermoplastic elastomer resin, it is necessary to prevent a portion of the side peripheral portion of the elastic plug from coming into contact with the molten resin and being thermally deformed during molding of the upper frame. can be done. As a result, the internal stress due to contact with the molten resin is reduced or the internal stress is prevented from disappearing, thereby preventing a decrease in holding force and restoring force against needle removal and a reduction in resealability after needle removal. can be done. In addition, by setting the height of the inner wall below the upper surface of the elastic stopper, it is possible to suppress the impediment of the filling of the molten resin, which is the constituent material of the upper frame, and the tip portion of the inner wall faces the elastic stopper. It is possible to prevent the generation of voids (bubbles) in.

Moreover, in the above configuration, it is preferable that a chamfered portion is provided on the outer peripheral edge portion at the tip of the inner wall. By providing a chamfered portion on the outer peripheral edge portion of the tip of the inner wall, the molten resin for forming the annular wall can flow between the inner wall and the outer wall without resistance when molding the upper frame portion. It can be made to flow easily.

Further, in the above configuration, the lower frame portion has an annular frame portion, the inner wall and the outer wall are erected on the annular frame portion, and the end face of the inner wall and the annular frame It is preferable to form an arbitrary angle with the standing surface on which the inner wall of the portion is erected. As a result, compared to the case where a corner R is provided between the end surface of the inner wall and the standing surface of the annular frame, for example, when the annular wall presses, the inner wall moves toward the elastic stopper side. It can make it easier to lean. As a result, it is possible to efficiently transmit the pressing force to the elastic stopper, and further improve the holding force and restoring force against needle removal and the resealing property after needle removal.

In order to solve the above problems, the method for manufacturing a medical cap according to the present invention comprises an elastic stopper, an upper frame supporting the peripheral edge of the elastic stopper from the upper surface, and a lower frame supporting the peripheral edge of the elastic stopper from the lower surface. A method of manufacturing a medical cap having an outer frame body having at least a frame portion, wherein the inner wall surrounds and accommodates a plurality of the elastic plugs using a first upper mold and a common lower mold. a step of forming the lower frame portion having an outer wall surrounding the inner wall; and a step of placing the elastic plug with its upper surface facing upward inside the inner wall of the lower frame portion. and using a second upper mold that can form a cavity for molding the upper frame portion when combined with the common lower mold, in the gap between the inner wall and the outer wall, the inner wall and the forming the upper frame portion having an annular wall for pressing the elastic plug, wherein the inner wall is welded at a contact surface with the annular wall and is welded with the elastic plug. The annular wall is welded to the elastic plug body in the gaps between the plurality of inner walls, and is welded to the contact surface of the outer wall.

In the above method, first, the lower frame portion is molded using the first upper mold and the common lower mold. In molding the lower frame, a plurality of inner walls surrounding and accommodating the elastic plugs and an outer wall surrounding the inner walls are formed at the same time. Next, the elastic stopper is placed on the placing portion of the lower frame so that its upper surface faces upward, and the upper frame is molded using the second upper mold and the common lower mold. At this time, an annular wall surrounding the inner wall is also formed on the upper frame portion at the same time. As a result, the contact surfaces between the annular wall of the upper frame portion and the inner and outer walls are welded together. In addition, since the annular wall is in contact with the elastic plug even in the gap between the inner walls, the structure is welded or closely attached at the contact surface. However, the elastic plug has a structure in which it is not welded to the inner wall. As a result, in the manufacturing method having the above configuration, for example, when the elastic plug is pierced with a needle, the positional deviation of the elastic plug and the outer frame prevents the occurrence of a gap and the occurrence of liquid leakage. A medical cap having excellent properties can be manufactured.

Further, since the upper frame portion is molded while pressing the inner wall toward the center, the elastic stopper is in a state where pressure is applied directly from the annular wall and indirectly via the inner wall. As a result, with the above method, it is possible to manufacture a medical cap that is excellent in holding force and restoring force against needle removal and that has improved resealing properties after needle removal.

In the step of forming the upper frame portion, the second upper mold having a protrusion having a diameter smaller than the diameter of the upper surface of the elastic plug is used as the common lower mold. When the second upper mold is closed, the protrusion presses at least the peripheral edge of the upper surface of the elastic stopper, thereby deforming the central portion of the upper surface into a convex shape. Preferably, the upper frame portion is molded by injecting molten resin into the cavity. According to this configuration, the protrusion of the second upper mold presses at least the peripheral portion of the upper surface of the elastic stopper, so that the upper frame portion can be molded while the central portion of the upper surface is deformed into a convex shape. done. As a result, the elastic stopper is held inside the outer frame in a state in which a compressive stress (caulking force) is applied, so that it is excellent in holding force and restoring force against needle removal and resealability after needle removal. It is possible to manufacture a medical cap with improved

In the above-described configuration, the step of forming the lower frame portion includes a step of forming the lower frame portion, in which a mounting portion for mounting the elastic plug is provided with an annular ridge portion for pressing the elastic plug. In the step of forming the upper frame portion, the projecting portion presses at least the peripheral portion of the upper surface of the elastic plug, so that the annular protrusion is formed on the side of the elastic plug. It can be performed in a state of being embedded in the lower surface of the peripheral part. As a result, the elastic plug can be held inside the outer frame in a state in which the annular protrusion is embedded in the lower surface of the side peripheral portion of the elastic plug. As a result, it is possible to manufacture a medical cap that further prevents the elastic stopper from being dislocated or coming off.

In the above configuration, the common lower die has a recess having a smaller diameter than the diameter of the lower surface of the elastic plug body. As a result, when the common lower mold and the second upper mold are closed, the lower surface of the elastic plug does not come into contact with the common lower mold. The upper frame portion is formed in a convexly deformed state. As a result, the elastic stopper can be held inside the outer frame in a state in which compressive stress (crimping force) is applied, and excellent holding and restoring force against needle removal and resealability after needle removal. It is possible to manufacture a medical cap with improved

In the above configuration, the elastic plug body is provided with a stepped portion on the peripheral edge of the upper surface thereof, and the step of forming the upper frame portion includes the stepped portion on the upper surface of the elastic plug body. It is preferable that the step is a step of forming an upper frame portion having a pressing portion that presses the stepped portion by pressing the peripheral edge portion excluding the stepped portion with the projection portion. According to the above configuration, when the elastic stopper having the stepped portion on the peripheral portion of the upper surface is used, the peripheral portion excluding the stepped portion is pressed by the protrusion when molding the upper frame portion. By doing so, it is possible to form a pressing portion capable of applying a compressive stress (caulking force) to the stepped portion. As a result, it is possible to manufacture a medical cap with further increased holding force and restoring force against needle removal and further improved resealability after needle removal.

In the above configuration, the step of forming the lower frame portion is preferably a step of forming the lower frame portion such that the height position of the outer wall is equal to or higher than the upper surface of the elastic plug. As a result, the contact surface with the outer wall is welded to the pressing portion, and the pressing portion can be held, and the compressive stress can be applied more efficiently to the peripheral edge portion and the stepped portion on the upper surface side of the elastic plug. can.

In the above-described configuration, in the step of forming the lower frame portion, the height position of the inner wall is equal to or higher than the height position of the side peripheral portion of the elastic plug, and the upper surface of the elastic plug is It is preferable that the step of molding the lower frame portion is as follows. When the elastic plug is made of rubber or thermoplastic elastomer resin by molding the lower frame so that the height of the inner wall is equal to or higher than the height of the side circumference of the elastic plug, It is possible to prevent the side peripheral portion from being unable to receive a substantially uniform pressing force from the inner wall in the height direction. Furthermore, when the elastic plug is made of a thermoplastic elastomer resin, it is necessary to prevent a portion of the side peripheral portion of the elastic plug from coming into contact with the molten resin and being thermally deformed during molding of the upper frame. can be done. As a result, the internal stress due to contact with the molten resin is reduced or the absence of internal stress is suppressed, and the reduction in the holding force and restoring force against needle removal and the reduction in resealability after removal of the needle are prevented. Caps for use can be manufactured. In addition, by setting the height of the inner wall below the upper surface of the elastic stopper, it is possible to suppress the impediment of the filling of the molten resin, which is the constituent material of the upper frame, and the tip portion of the inner wall faces the elastic stopper. It is possible to obtain a medical cap that prevents the generation of voids (bubbles) in the above.

In the above configuration, the step of forming the lower frame portion is preferably a step of forming the inner wall having a chamfered portion on the outer peripheral portion at the tip of the inner wall. By forming a chamfered portion on the outer peripheral edge portion of the tip of the inner wall, the molten resin for forming the annular wall can also resist between the inner wall and the outer wall when forming the upper frame portion. can be made to flow easily without

Further, in the above configuration, the step of forming the lower frame portion is a step of forming the lower frame portion having an annular frame portion for erecting the inner wall and the outer wall. It is preferable that the annular frame portion is formed so that an end surface of the inner wall and an upright surface of the inner wall of the annular frame form an arbitrary angle. As a result, compared to the case where a corner R is provided between the end face of the inner wall and the erected surface of the annular frame, for example, when pressed from the annular wall, the stopper tends to tilt toward the elastic plug. An internal wall can be formed. As a result, it is possible to efficiently transmit the pressing force to the elastic stopper, and to manufacture a medical cap that is more excellent in holding force and restoring force against needle removal and resealability after needle removal. can be done.

The medical cap of the present invention has an elastic plug and an outer frame for holding the elastic plug inside, and the lower frame part of the outer frame surrounds and accommodates a plurality of the elastic plugs. An inner wall and an outer wall surrounding the inner wall. Further, the upper frame portion of the outer frame has an annular wall for pressing the inner wall and the elastic plug in the gap between the inner wall and the outer wall. This annular wall is welded to the contact surfaces of the inner and outer walls. Further, the elastic plug is in contact with and welded or tightly attached to the annular wall in the gaps between the inner walls. Further, a stepped portion is provided on the peripheral edge portion on the upper surface side of the elastic plug, and the stepped portion is pressed by the pressing portion of the upper frame portion. Therefore, for example, when the elastic plug is pierced with a needle, it is possible to prevent the occurrence of a gap due to the positional deviation between the elastic plug and the support. Furthermore, it is possible to prevent the occurrence of liquid leakage and to secure the airtightness. Further, the elastic stopper is directly pressed by the annular wall and indirectly via the inner wall, and is also pressed by the pressing portion of the upper frame. Therefore, it is possible to provide a medical cap that is excellent in holding force and restoring force against needle removal, and also excellent in resealability after needle removal.

In the method of manufacturing the medical cap of the present invention, the elastic stopper is housed inside the preformed lower frame, and then the upper frame is formed. When forming the upper frame portion, the ring-shaped protrusion provided on the first upper mold presses the peripheral portion of the upper surface of the elastic plug. Also, by forming an annular wall in the gap between the inner wall and the outer wall, the inner wall is pressed toward the center. Therefore, a pressing force is applied to the stepped portion of the elastic plug from the pressing portion of the upper frame portion, and a pressing force is applied to the side peripheral surface of the elastic plug directly from the annular wall and indirectly via the inner wall. A medical cap can be manufactured that is in a folded state. As a result, the holding force and restoring force against needle removal are excellent, and the resealing property after needle removal can be improved. In addition, in the method of manufacturing the medical cap of the present invention, the upper frame portion is formed so that the annular wall is located in the gap between the outer wall and the inner wall. The contact surface with can be of a welded structure. Furthermore, since a plurality of internal walls are provided, the annular wall can be made to have a structure in which it contacts and welds or adheres to the elastic plug in the gaps between the plurality of internal walls. That is, with the above-described method, a medical cap having a structure in which the elastic stopper and the upper frame portion, and the upper frame portion and the lower frame portion are welded to each other, can be manufactured. Therefore, for example, when the elastic plug is pricked with a needle, it is possible to prevent the occurrence of voids and liquid leakage due to misalignment between the elastic plug and the support, and to provide a medical cap with excellent airtightness.

FIG. 1(a) is a schematic cross-sectional view for explaining the medical cap according to Embodiment 1, and FIG. 1(b) is a plan view of the medical cap in plan view. FIG. 2(a) is a schematic cross-sectional view for explaining the lower frame portion of the outer frame in the medical cap, and FIG. 2(b) is a plan view of the lower frame portion. represents the figure. FIG. 4 is an enlarged view of a main portion showing an engaged portion provided on a lower frame portion of the outer frame of the medical cap. FIG. 4 is a schematic cross-sectional view for explaining an upper frame portion of an outer frame body in the medical cap. Fig. 5(a) is a side view showing the elastic plug in the medical cap, Fig. 5(b) is a plan view showing the needle sticking surface side of the elastic plug, and Fig. 5(c). is a bottom view showing the wetted surface side of the elastic stopper. FIG. 4 is a cross-sectional view for explaining the method of manufacturing the medical cap, in which FIG. The mold is opened, and FIG. 1(c) shows the elastic plug 2 placed on the lower frame. It is an enlarged sectional view showing the outline of the engaging part in a common lower metal mold|die. It is a cross-sectional view for explaining the manufacturing method of the medical cap, in which FIG. FIG. 10(b) shows the second upper mold and the common lower mold closed, and FIG. 11(c) shows the upper frame part molded and opened. FIG. 9(a) is a schematic cross-sectional view for explaining a medical cap according to Embodiment 2, and FIG. 9(b) is a plan view of the medical cap in plan view. FIG. 10(a) is a schematic sectional view for explaining the lower frame portion of the outer frame in the medical cap, and FIG. 10(b) is a plan view of the lower frame portion. show. FIG. 4 is a cross-sectional view for explaining the method of manufacturing the medical cap, in which FIG. The mold is opened, and FIG. 1(c) shows the elastic plug 2 placed on the lower frame. It is a cross-sectional view for explaining the manufacturing method of the medical cap, in which FIG. FIG. 10(b) shows the second upper mold and the common lower mold closed, and FIG. 11(c) shows the upper frame part molded and opened. Fig. 3 is an enlarged cross-sectional view of a main part showing a chamfered portion provided on the outer peripheral edge portion of the tip of the inner wall, wherein (a) shows the case where the chamfered portion is a sloped surface, and (b) shows the chamfered portion; represents the case where the chamfered portion is the C surface, and FIG. It is a perspective view which represents roughly a mode that an internal wall erects on an annular frame part. Fig. 10 is a cross-sectional view showing another aspect of the second upper mold used in the method for manufacturing the medical cap, wherein (a) shows a case where the protrusion is cylindrical, and (b) shows a case where the protrusion is cylindrical; FIG. 3(c) shows a case where the protruding portion swells into a convex shape at the center.

(Embodiment 1)
[Medical Cap]
A medical cap according to Embodiment 1 will be described below with reference to FIGS. 1 to 5. FIG. However, parts that are not necessary for explanation are omitted, and some parts are enlarged or reduced in order to facilitate explanation.

FIG. 1(a) is a schematic cross-sectional view for explaining the medical cap according to this embodiment, and FIG. 1(b) is a plan view of the medical cap in plan view. FIG. 2(a) is a schematic cross-sectional view for explaining the lower frame portion of the outer frame of the medical cap, and FIG. 2(b) is a plan view of the lower frame portion. show. FIG. 3 is an enlarged view of a main portion showing an engaged portion in the lower frame portion of the outer frame. FIG. 4 is a schematic cross-sectional view for explaining the upper frame portion of the outer frame in the medical cap. FIG. 5(a) is a side view showing an elastic plug in a medical cap, FIG. 5(b) is a plan view showing the needle sticking surface side of the elastic plug, and FIG. It is a bottom view showing the wetted surface side of the elastic stopper.

As shown in FIG. 1(a), a medical cap 10 according to this embodiment includes at least an outer frame 1 and an elastic stopper 2. As shown in FIG. The outer frame 1 is capable of holding the elastic plug 2 inside, and is in contact with the upper frame 11 that supports at least the peripheral edge 26 of the elastic plug 2 from the needle sticking surface 21 (upper surface) side. and a lower frame portion 12 that supports from the liquid surface 22 (lower surface) side (see FIGS. 1B and 2). The elastic plug body 2 is held by the outer frame body 1 in a state in which both the needle puncture surface 21 and the liquid contact surface 22 are deformed into a convex shape. The degree of deformation of the needle sticking surface 21 and the wetted surface 22 is not particularly limited. For example, there are cases where the entire needle sticking surface 21 and/or the liquid contacting surface 22 are deformed into a convex shape, or cases where the central portion of the needle sticking surface 21 and/or the liquid contacting surface 22 are deformed into a convex shape. mentioned.

The lower frame portion 12 includes at least an annular frame portion 16, an inner wall 14, an outer wall 19, and an opening 20, as shown in FIGS. 2(a) and 2(b). The lower frame portion 12 is preferably a rigid molding except for the inner wall portion 14, so that the medical cap 10 with excellent shape stability can be provided.

As shown in FIG. 2(b), a plurality of the inner walls 14 are arranged in an annular manner on the annular frame portion 16. As shown in FIG. In addition, the plurality of inner walls 14 surround the side peripheral portion 23 of the elastic plug 2 to accommodate the elastic plug 2 . The inner walls 14 are spaced apart from each other, and a gap 15 is provided. The distance of the gap 15 is not particularly limited, and can be appropriately set according to the diameter of the medical cap 10 and the number of inner walls 14 . However, it is preferable that the inner walls 14 are arranged at regular intervals. As a result, the pressure applied to the elastic plug 2 via the inner wall 14 can be prevented from being biased. Moreover, it is preferable that the gap 15 is such that the inner walls 14 do not come into contact with each other due to pressure from the annular wall 13 (details of which will be described later). As a result, it is possible to prevent the pressing force of the inner wall 14 against the elastic stopper 2 from being reduced, and to further improve the holding force and restoring force against needle removal and the resealing property after needle removal. Specifically, the distance between adjacent inner walls 14 is preferably in the range of 0.5 mm to 10 mm, more preferably in the range of 1 mm to 3 mm. By setting the distance of the gap to 0.5 mm or more, it is possible to avoid contact between adjacent inner walls 14 when the inner walls 14 are pressed toward the center. On the other hand, by setting the distance of the gap to 10 mm or less, the bias of the pressure applied to the elastic plug 2 can be reduced.

The width of the inner walls 14 can be appropriately set according to the number and size of the elastic plugs 2 . The width of the inner wall 14 is generally preferably in the range of 1.5 mm to 15 mm, more preferably in the range of 3 mm to 9 mm. Also, the number of inner walls 14 is not particularly limited, and can be appropriately set as required. For example, the inner walls 14 may be arranged oppositely. As a result, the inner wall 14 can be uniformly deformed in the same direction, and the pressure applied to the elastic plug 2 can be prevented from being biased.

In addition, it is preferable that the inner wall 14 has a characteristic of indirectly transmitting the pressing force from the annular wall 13 to the elastic plug 2 . From this point of view, it is preferable that at least the inner wall 14 portion of the lower frame portion 12 is made of a flexible molding. As a result, when pressed from the annular wall 13, it can be deflected so as to incline toward the elastic plug 2 without resisting the pressing force. As a result, the elastic plug 2 can be held in the outer frame 1 in a state in which the wetted surface 22 thereof is deformed into a convex shape. In addition, since a pressing force can be effectively applied to the elastic plug 2, it is possible to further improve the holding force and restoring force against needle removal and the resealing property after needle removal.

Although the thickness of the inner wall 14 is not particularly limited, it must be bent so as to be inclined toward the elastic plug 2 against pressure from the annular wall 13 . From such a point of view, it is preferably in the range of 0.3 mm to 2 mm, more preferably in the range of 0.5 mm to 1 mm.

The inner wall 14 is welded to the annular wall 13 at the contact surface, whereby the upper frame portion 11 and the lower frame portion 12 form an integrated structure to form the outer frame body 1 . As will be described later, the term "welding" means that the surface of the inner wall 14 in contact with the upper frame portion 11 melts due to the heat of the molten resin that is injected when the upper frame portion 11 is molded by injection molding or the like. It means that the annular wall 13 and the inner wall 14 are in a state of being joined at their contact surfaces after the upper frame portion 11 is molded. The inner wall 14 is not welded at the contact surface with the elastic plug 2 .

The height position of the inner wall 14 is equal to or higher than the height position of the side peripheral portion 23 of the elastic plug 2 when the elastic plug 2 is accommodated therein, and the needle puncture surface of the elastic plug 2. The height is preferably 21 or less, and more preferably substantially the same as the height position of the side peripheral portion 23 of the elastic plug 2 . By setting the height position of the inner wall 14 to be equal to or higher than the height position of the side peripheral portion 23 of the elastic plug 2, when the elastic plug 2 is made of rubber or thermoplastic elastomer resin, the side peripheral portion 23 In the height direction, it is possible to prevent the inner wall 14 from not receiving a substantially uniform pressing force. Furthermore, when the elastic plug 2 is made of a thermoplastic elastomer resin, part of the side peripheral portion 23 of the elastic plug 2 contacts the molten resin and is thermally deformed when the upper frame portion 11 is molded. to prevent As a result, the internal stress due to contact with the molten resin is reduced or the internal stress is prevented from disappearing, thereby preventing a decrease in holding force and restoring force against needle removal and a reduction in resealability after needle removal. can be done. In addition, by setting the height of the inner wall 14 to be lower than the needle sticking surface 21 of the elastic plug 2, it is possible to prevent the generation of voids (bubbles) at the tip of the inner wall 14 on the side of the elastic plug 2. can do. The “height position” of the inner wall 14 means the position of the top of the inner wall 14 in the vertical direction with respect to the mounting portion 17 . Further, the “height position” of the side peripheral portion 23 means the position of the upper end of the side peripheral portion 23 in the vertical direction with respect to the mounting portion 17 .

Moreover, the cross-sectional shape of the inner wall 14 is not particularly limited. For example, the cross-sectional shape of the inner wall 14 may be tapered toward the top. Also, the thickness at the bottom of the inner wall 14 may be equal to or less than at the top. As a result, the pressure applied to the elastic stopper 2 can be increased even at the bottom of the inner wall 14 . In addition, the thickness of the inner wall 14 shall be suitably set within the above-mentioned numerical range. Furthermore, the shape of the inner wall 14 in a plan view may be trapezoidal instead of quadrangular.

A mounting portion 17 on which the elastic plug 2 can be mounted is provided at the bottom of the inner wall 14 . The mounting portion 17 is provided so as to project annularly from the inner wall 14 toward the center. As a result, the peripheral portion 24 of the wetted surface 22 of the elastic plug 2 can be supported. As a result, for example, it is possible to prevent the elastic plug 2 from being pushed out of the lower frame portion 12 during needle sticking. In addition, in the present embodiment, the case where the mounting portion 17 is ring-shaped is exemplified, but the present invention is not limited to this. For example, a mode in which a plurality of placement portions are provided at predetermined intervals may be used. In this case, the distance between the adjacent mounting portions is not particularly limited as long as the elastic stopper 2 can be supported to the extent that the elastic stopper 2 is not pushed out from the lower frame portion 12 when the upper frame portion 11 is formed. .

The outer wall 19 is provided on the annular frame portion 16 so as to surround the inner wall 14 in an annular shape. Further, the outer wall 19 is welded at the contact surface with the upper frame portion 11 including the annular wall 13 (details will be described later). As a result, the upper frame portion 11 can be integrally coupled with the lower frame portion 12, and the upper frame portion 11 can be prevented from coming off. In addition, the outer wall 19 can resist the restoring force of the inner wall 14 and the elastic stopper 2, and also has the function of stabilizing the shape of the medical cap. The above-mentioned "welding" means that the surface of the outer wall 19 in contact with the upper frame portion 11 melts due to the heat of the molten resin that is injected when the upper frame portion 11 is molded by injection molding or the like. After molding, the outer wall 19 and the upper frame portion 11 are in a bonded state at their contact surfaces.

The height position of the outer wall 19 is preferably equal to or higher than the needle puncture surface 21 of the elastic plug 2 . If the height position of the external wall 19 is lower than the needle sticking surface 21, it becomes difficult to weld and hold the pressing portion 28 (details will be described later) at the contact surface with the external wall 19. . As a result, the compressive stress may not be applied sufficiently to the peripheral edge portion and the stepped portion 25 on the upper surface side of the elastic plug 2 . Specifically, the height of the outer wall 19 is preferably within the range of 4 mm to 20 mm, more preferably within the range of 5 mm to 18 mm. Although the thickness of the outer wall 19 is not particularly limited, it is preferably thicker than the inner wall 14 from the viewpoint of retaining the shape of the outer frame 1 . Specifically, the thickness of the outer wall 19 is preferably in the range of 0.3 mm to 3 mm, more preferably in the range of 0.4 mm to 2 mm.

The distance between the outer wall 19 and the inner wall 14 can be appropriately set according to the shape of the annular wall 13 of the upper frame portion 11, which will be described later. Specifically, it is preferably in the range of 0.3 mm to 5 mm, more preferably in the range of 0.5 mm to 2 mm. Also, the distance of the gap may be narrowed toward the bottom of the outer wall 19 and the inner wall 14 within the above numerical range.

The opening 20 is provided on the inner periphery of the annular frame 16 so as to protrude outward. This allows the opening 20 to mate with a container mouth (not shown). The opening diameter and outer diameter of the opening 20 can be appropriately set according to the size of the opening of the container and the needle sticking area. Also, the height H of the opening 20 (that is, the distance from the annular frame 16 to the tip of the opening 20) is not particularly limited and can be set as appropriate.

As shown in FIG. 3, the inner peripheral surface of the opening 20 is provided with an engaged portion 27 for engaging with a common lower mold (details of which will be described later). As a result, for example, after molding the lower frame portion 12, the molded lower frame portion 12 can be engaged and fixed to the common lower mold when the mold is opened. The engaged portion 27 according to the present embodiment is an annular concave portion. However, the shape of the engaged portion 27 is not limited to this, and may be, for example, an annular convex portion. The depth and width of the engaged portion 27 are not particularly limited as long as the lower frame portion 12 can be engaged with and fixed to the common lower mold, and can be set as appropriate.

The upper frame portion 11 includes an annular wall 13 surrounding the inner wall 14 , a pressing portion 28 that presses a step portion 25 (details of which will be described later) of the elastic plug 2 , the annular wall 13 and the pressing portion 28 . It is a structure including at least an annular frame portion 18 that supports the . The annular wall 13 has a function of pressing the elastic plug 2 through the inner wall 14 of the lower frame portion 12 . Further, the pressing portion 28 has a function of pressing the peripheral edge portion on the upper surface side of the elastic plug 2 and the step portion 25, thereby maintaining the needle sticking surface 21 in a convexly deformed state.

The annular wall 13 of the upper frame portion 11 is welded at the contact surfaces with the inner wall 14 and the outer wall 19 of the lower frame portion 12 as described above. The annular wall 13 is also in contact with the elastic plug 2 in the gap 15 between the plurality of inner walls 14 and is welded or closely attached. As a result, the annular wall 13 can apply a direct pressing force to the elastic plug 2 as well, and the deformed state of the elastic plug 2 can be maintained. Also, the annular frame portion 18 of the upper frame portion 11 is welded or closely attached to the contact surface of the peripheral portion 26 of the elastic plug 2 as well. As a result, when the needle sticking surface 21 of the elastic plug 2 is pierced with a needle, it is possible to prevent the peripheral portion 26 of the elastic plug 2 from creating a gap between it and the upper frame portion 11 . Here, as in the case described above, the term "welding" refers to the heat of the molten resin that is injected when the upper frame portion 11 is molded by injection molding or the like when the elastic plug 2 is made of a thermoplastic elastomer resin. means that the surface of the elastic plug 2 in contact with it is melted, so that the annular wall 13 and the elastic plug 2 are joined at their contact surfaces after the upper frame 11 is molded. do. When the elastic plug 2 is made of rubber (the details of the constituent materials will be described later), the annular wall 13 is in close contact with the elastic plug 2 in the gap 15 between the inner walls 14 . . This is because the surface of the elastic plug 2 does not melt even with the heat of the molten resin injected during injection molding or the like. However, since the annular wall 13 is molded while pressing against the elastic plug 2, the two are in close contact with each other.

The height of the annular wall 13 is basically the same as the depth of the gap because the annular wall 13 is formed by flowing molten resin into the gap between the inner wall 14 and the outer wall 19 .

As a material for forming the outer frame 1 (the upper frame portion 11 and the lower frame portion 12), among synthetic resins, those whose safety for medical use has been established can be preferably used. Among them, it is common to use a thermoplastic resin. Specifically, resins conventionally used for medical applications, such as polyethylene, polypropylene, and PET (polyethylene terephthalate) resins, are preferable, but the present invention is not limited to these. Since the upper frame portion 11 and the lower frame portion 12 are welded together to form the outer frame body 1, the constituent materials used for each are the same material or compatible materials. is preferred. Also, one or both of the upper frame portion 11 and the lower frame portion 12 may be added with an arbitrary component such as a coloring agent.

The elastic plug 2 is preferably accommodated inside the inner wall 14 of the lower frame portion 12 with the needle puncture surface 21 facing upward and the liquid contact surface 22 facing downward. Here, the "needle puncture surface" means the surface where the medical cap 10 according to the present embodiment is attached to the drug container and is punctured by the puncture needle when taking out the liquid medicine or the like. In addition, the “liquid contact surface” means the surface that is in contact with the liquid medicine or the like stored in the drug container. The needle puncture surface 21 is provided with three recesses 21a that serve as position indicators when the puncture needle is punctured. However, the number of concave portions 21a is not particularly limited, and at least one concave portion 21a may be provided.

The overall shape of the elastic plug 2 is not particularly limited, but in this embodiment, it is substantially columnar as shown in FIGS. 5(a) to 5(c). However, a stepped portion 25 is provided on the peripheral portion 26 on the needle sticking surface 21 side. A peripheral portion 24 is provided on the side of the liquid contact surface 22 so that the elastic plug 2 can be placed on the placement portion 17 of the lower frame portion 12 . The shape of the elastic plug 2 is not limited to that shown in FIG. 5(a). good.

A side peripheral portion 23 of the elastic plug 2 is provided with an engaged portion 23a for engaging the elastic plug 2 with a mold. As a result, for example, when the mold is opened after molding the elastic plug 2, the molded elastic plug 2 can be engaged with and fixed to the mold. As a result, it is possible to prevent the elastic plug 2 from coming into close contact with the other mold and causing mold release failure.

The overall diameter of the elastic plug 2 is not particularly limited as long as it can be accommodated inside the inner wall 14 of the outer frame 1 . However, if the diameter of the elastic plug 2 is too small, it will be difficult to bring the inner wall 14 into close contact with the side peripheral portion 23 of the elastic plug 2 even if the inner wall 14 is pressed by the annular wall 13 and tilted in the direction in which the diameter of the inner wall 14 decreases. It is not preferable because it becomes Specifically, the diameter of the elastic plug 2 is set within the range of 10 mm to 30 mm. Furthermore, it is preferable that the diameter of the elastic plug 2 is set smaller than the inner diameter of the inner wall 14 of the lower frame portion 12 within the range of 0.03 mm to 1 mm. This ensures ease of insertion of the elastic plug 2 inside the inner wall 14 . The diameter of the needle sticking surface 21 of the elastic plug 2 (diameter excluding the stepped portion 25 on the upper surface side) is not particularly limited, but is usually set in the range of 10 mm to 30 mm. The diameter of the wetted surface 22 of the elastic stopper 2 (diameter excluding the peripheral edge 24 on the lower surface side) is not particularly limited, but is usually set within the range of 10 mm to 30 mm. Furthermore, the thickness of the elastic plug 2 (the distance between the needle puncture surface 21 and the wetted surface 22) is not particularly limited, but is usually within the range of 2.5 mm to 12 mm, preferably within the range of 3 mm to 9 mm. .

The characteristics of the elastic plug 2 are not particularly limited as long as it has hardness enough to allow a medical injection needle or the like to penetrate. In addition, it is preferable that the shape retainability is such that it is not easily deformed or damaged during normal storage. The hardness of the elastic plug 2 is preferably A5 to A50, more preferably A10 to A45, as measured by the JIS K6253 method.

Examples of materials used for the elastic plug 2 include rubber and thermoplastic elastomers. The rubber is not particularly limited, and examples thereof include natural rubber, isoprene rubber, butadiene rubber, styrene-butadiene rubber, isoprene-isobutylene rubber, and the like. The thermoplastic elastomer is not particularly limited, and examples thereof include olefin-based, styrene-based, polyurethane-based, polyester-based, polyvinyl chloride-based, and polybutadiene-based elastomers. Among them, thermoplastic elastomers (SEBS, SEPS, HSBR, SEBR, CEBC) obtained by hydrogenating conjugated diene thermoplastic elastomers are preferable.

Thermoplastic elastomer materials are much more hygienic than rubber materials, but the wetted surface 22 of the elastic plug 2 may be laminated depending on the chemical solution to be used. The lamination generally uses the same type of resin as the lower frame 12 or container body to which it is to be attached. As a result, it is possible to use a material having the same or similar properties as the liquid contact surface 22 of the elastic stopper 2 or the inside of the container with which the liquid medicine contacts.

In the medical cap 10 according to the present embodiment, the elastic stopper 2 is pressurized toward the center thereof by applying pressure directly from the annular wall 13 and indirectly via the inner wall 14 . An upper frame part 11 with a wall 13 is molded. Although the pressure applied to the elastic plug 2 depends on the shape and thickness of the inner wall 14 and the annular wall 13, it usually acts toward the liquid contact surface 22 on the central axis of the elastic plug 2. do. Also, the pressure applied to the elastic plug 2 decreases toward the liquid contact surface 22 side. Further, pressure is applied to the stepped portion 25 of the elastic plug 2 from the pressing portion 28 of the upper frame portion 11, and the pressure is also directed toward the liquid contact surface 22 on the central axis of the elastic plug 2. works.

Due to these actions, the restoring force of the elastic plug 2 itself acts in the direction of the side peripheral surface of the elastic plug 2 and tends to expand. As a result, when the needle puncture surface 21 of the elastic plug body 2 is punctured with a needle, it is possible to prevent the liquid from leaking and to improve the holding force and the restoring force against the needle coming out. Furthermore, when the needle is pulled out, the elastic plug 2 receives a force from the inner wall 14 that pushes it toward the needle sticking surface on the central axis, so that the hole made by the needle can be closed. As a result, excellent resealing properties after the needle is pulled out can be achieved. The liquid-contacting surface 22 side of the elastic plug 2 may have a shape in which the central portion is slightly bulged like a protruding line. In addition, in the present embodiment, a medical cap having a circular cross-section has been described as an example, but the present invention is not limited to this. The shape is not particularly limited.

[Method for producing medical cap]
Next, a method for manufacturing a medical cap according to this embodiment will be described with reference to FIGS. 6 to 8. FIG.
6A and 6B are cross-sectional views for explaining the method of manufacturing the medical cap according to Embodiment 1, in which FIG. The first upper mold and the common lower mold are opened, and FIG. 1(c) shows the elastic stopper placed on the lower frame. FIG. 7 is an enlarged cross-sectional view showing an outline of an engaging portion in the common lower mold. 8A and 8B are cross-sectional views for explaining the method of manufacturing a medical cap, and FIG. The figure (b) shows how the second upper mold and the common lower mold are closed, and the figure (c) shows how the upper frame is molded and opened. represents

The method of manufacturing the medical cap 10 includes the steps of forming the lower frame portion 12, placing the elastic plug 2 on the formed lower frame portion 12, and forming the upper frame portion 11. include.

The molding process of the lower frame portion 12 is performed by injection molding the lower frame portion 12 using a first upper mold 42 and a common lower mold 41, as shown in FIG. 6(a). The first upper mold 42 is a core (convex mold), and the common lower mold 41 is a cavity (concave mold). The first upper mold 42 and the common lower mold 41 have a structure in which a cavity capable of molding the lower frame portion 12 is formed when both are closed. In addition, the common lower mold 41 is provided with a concave portion 46 that is circular in plan view in order to deform the liquid contact surface 22 side of the elastic stopper 2 into a convex shape (Fig. 6(b)). )reference). Although the depth of the recessed portion 46 is not particularly limited, it is usually in the range of 0.5 mm to 3 mm, preferably in the range of 0.5 mm to 1 mm. The diameter of the recessed portion 46 is also not particularly limited, and is set to be smaller than the diameter of the liquid-contacting surface 22 of the elastic plug 2 . Furthermore, as shown in FIG. 7, an engaging portion 45 protruding annularly is provided on the inner peripheral surface of the recessed portion 46 . This enables the engaged portion 27 to be formed on the inner peripheral surface of the opening 20 of the lower frame portion 12 .

Molten resin 47, which is a melted resin constituting the lower frame portion 12, passes through the sprue and runner in the first upper mold 42 and is injected into the cavity from the gate 42a. The injection pressure is not particularly limited, and can be set appropriately as required. The injected molten resin 47 is cooled for a predetermined time. The cooling time is not particularly limited, and can be set appropriately as required.

Next, as shown in FIG. 6B, the first upper mold 42 and the common lower mold 41 are opened. At this time, the lower frame portion 12 is fixed to the common lower mold 41 by engaging the engaged portion 27 with the engaging portion 45 of the common lower mold 41 . As a result, in the present embodiment, when the first upper mold 42 and the common lower mold 41 are opened, the lower frame portion 12 is in close contact with the first upper mold 42, resulting in mold release failure. can be prevented from occurring. As a result, a decrease in manufacturing efficiency can be prevented.

Next, as shown in FIG. 6(c), the elastic plug 2 is placed on the placement portion 17 of the lower frame portion 12 so that the needle puncture surface (upper surface) 21 faces upward. Here, it is preferable that the inner diameter of the opening 20 of the lower frame 12 is designed and formed to be smaller than the diameter of the liquid-contacting surface 22 of the elastic stopper 2 . As a result, when the elastic plug 2 is placed on the placement portion 17, there is a gap of, for example, several mm between the inner peripheral surface of the opening 20 and the portion forming the liquid contact surface 22 of the elastic plug 2. A degree of clearance can be provided annularly. As a result, it is possible to easily insert the elastic plug 2 into the lower frame portion 12 .

The method of manufacturing the elastic plug 2 is not particularly limited, and for example, it can be manufactured by compression molding or injection molding while crushing a thermoplastic elastomer.

Subsequently, as shown in FIG. 8A, the upper frame portion 11 is molded. A second upper mold 43 and a common lower mold 41 are used for molding the upper frame portion 11 . The second upper mold 43 is provided with a ring-shaped projection (projection) 44 for pressing the peripheral edge 26 of the needle sticking surface 21 of the elastic plug 2 . The second upper mold 43 and the common lower mold 41 are structured to form a cavity in which the upper frame portion 11 can be molded when both are closed.

When the second upper mold 43 and the common lower mold 41 are closed, the ring-shaped protrusion 44 abuts on the peripheral edge 26 of the needle sticking surface 21 of the elastic plug 2 and deforms it. As a result, the needle puncture surface 21 side is deformed into a convex shape. In addition, the common lower mold 41 is provided with a recess 46 so that the wetted surface 22 of the elastic plug 2 is not supported when the second upper mold 43 and the common lower mold 41 are closed. It's becoming Therefore, when the mold is closed, the liquid contact surface 22 side is also deformed into a convex shape (see FIG. 8(b)). In addition, by bringing the ring-shaped projection 44 into contact with the peripheral edge 26 of the needle-pricking surface 21 of the elastic plug 2 , the molten resin will spread between the needle-pricking surface 21 of the elastic plug 2 and the second upper mold 43 . It is also possible to prevent the liquid from flowing into the gap.

The outer diameter r of the ring-shaped projection 44 is appropriately set according to the shape and size of the upper frame 11 to be molded, but is preferably smaller than the diameter of the needle piercing surface 21 of the elastic plug 2 . However, if the outer diameter r is too small, the annular frame portion 18 of the upper frame portion 11 is formed to be unnecessarily large. sometimes.

Moreover, the height h of the ring-shaped projection 44 is not particularly limited, and is appropriately set according to the size of the elastic plug 2, the shape of the upper frame 11 to be molded, and the like. Usually, it is preferably within the range of 0.3 to 6 mm, more preferably within the range of 0.8 to 4 mm. By setting the height h to 6 mm or less, it is possible to prevent difficulty in closing the second upper mold 43 and the common lower mold 41 . On the other hand, if the height h is set to 0.3 mm or more, it becomes insufficient to push down the central portion of the elastic plug 2, so that the compressive stress directed toward the center of the elastic plug 2 does not occur. can be prevented.

Next, a melted resin, which is a component material of the upper frame portion 11, is injected into the cavity formed by closing the mold. The molten resin passes through the sprue and runner in the second upper mold 43 and is injected into the cavity from the gate 43a. Here, the position of the gate 43 a is provided outside the ring-shaped projection 44 so that the molten resin can be injected toward the stepped portion 25 of the elastic plug 2 . Further, the gates 43a are provided at four positions, which are arranged at regular intervals. As for the positions of the gates 43a, the case where the gates 43a are provided at four positions has been described as an example in the present embodiment, but the present invention is not limited to this, and at least a plurality of gates 43a may be provided. Therefore, for example, three gates 43a may be provided at equal intervals. The injection pressure is not particularly limited, and can be set appropriately as required. The injected molten resin is cooled for a predetermined time. The cooling time is not particularly limited, and can be set appropriately as required. After the mold is opened, the upper frame portion 11 is formed as shown in FIG. 8(c).

As described above, the outer frame body 1 in which the upper frame portion 11 and the lower frame portion 12 are integrated is formed, and the medical cap 10 according to the present embodiment is obtained.

(Embodiment 2)
[Medical Cap]
A medical cap according to Embodiment 2 will be described below with reference to FIGS. 9 and 10. FIG. FIG. 9(a) is a schematic cross-sectional view for explaining the medical cap according to this embodiment, and FIG. 9(b) is a plan view of the medical cap in plan view. FIG. 10(a) is a schematic sectional view for explaining the lower frame portion of the outer frame in the medical cap, and FIG. 10(b) is a plan view of the lower frame portion. show. Components having functions similar to those of the medical cap 10 of Embodiment 1 are denoted by the same reference numerals, and detailed description thereof is omitted.

The medical cap 10' according to the second embodiment differs from the first embodiment in that an annular projection 17a is provided on the mounting portion 17 of the lower frame portion 12' ( See Figures 9(a) and 9(b)). With such a structure, it is possible to embed the annular projection 17a in the lower surface of the side peripheral portion 23 of the elastic plug 2, thereby further preventing the elastic plug 2 from being dislocated or falling off. be able to.

As shown in FIGS. 10(a) and 10(b), the annular projection 17a is annularly provided on the innermost periphery of the mounting portion 17. As shown in FIGS. However, the annular ridge portion 17a is not limited to a ridge. For example, the projections may be arranged in a ring shape at arbitrary intervals. Further, the position where the annular protrusion 17a is formed is not limited as long as it can be embedded in the lower surface of the side peripheral portion 23 of the elastic plug 2 .

The height of the annular protrusion 17a is not particularly limited as long as it can be embedded in the lower surface of the side peripheral portion 23 of the elastic plug 2, and is appropriately set according to the hardness of the elastic plug 2 and the like. Also, the width of the annular projection 17a in a cross-sectional view is not particularly limited as long as it can be embedded in the lower surface of the side peripheral portion 23 of the elastic plug 2, and depends on the hardness of the elastic plug 2 and the like. Appropriately set.

[Method for producing medical cap]
Next, a method for manufacturing a medical cap according to this embodiment will be described with reference to FIGS. 11 and 12. FIG.
11A and 11B are cross-sectional views for explaining a method for manufacturing a medical cap according to Embodiment 2, in which FIG. The first upper mold and the common lower mold are opened, and FIG. 1(c) shows the elastic stopper placed on the lower frame. 12A and 12B are cross-sectional views for explaining the method of manufacturing a medical cap, and FIG. The figure (b) shows how the second upper mold and the common lower mold are closed, and the figure (c) shows how the upper frame is molded and opened. represents

First, as shown in FIG. 11(a), the molding process of the lower frame portion 12' is performed by injection molding the lower frame portion 12' using the first upper mold 42' and the common lower mold 41. It is done by The first upper mold 42' is a core (convex type). The first upper mold 42' and the common lower mold 41 are arranged so that the lower frame portion 12' having the annular ridge portion 17a provided on the mounting portion 17 can be molded when both molds are closed. A cavity is formed in the structure.

A molten resin 47, which is a constituent material of the lower frame portion 12', passes through the sprue and runner in the first upper mold 42' and is injected into the cavity from the gate 42a. The injection pressure is not particularly limited, and can be set appropriately as required. The injected molten resin 47 is cooled for a predetermined time. The cooling time is not particularly limited, and can be set appropriately as required.

Next, as shown in FIG. 11(c), after opening the first upper mold 42′ and the common lower mold 41, the annular ridge on the mounting portion 17 of the lower frame portion 12 The elastic plug 2 is placed on the portion 17a so that the needle puncture surface (upper surface) 21 faces upward.

Subsequently, as shown in FIG. 12(a), the upper frame portion 11 is molded. A second upper mold 43 and a common lower mold 41 are used for molding the upper frame portion 11 . When the second upper mold 43 and the common lower mold 41 are closed, a cavity that enables molding of the upper frame portion 11 is formed. In addition, the ring-shaped protrusion 44 abuts on the peripheral edge portion 26 of the liquid contact surface 22 of the elastic plug 2 and deforms it, so that the needle sticking surface 21 side of the elastic plug 2 deforms into a convex shape. Further, the annular protrusion 17a provided on the mounting portion 17 is embedded in the lower surface of the side peripheral portion 23 of the elastic plug 2 (see FIG. 12(b)).

Next, a molten resin obtained by melting the resin constituting the upper frame portion 11 is injected into the cavity formed by closing the mold and allowed to cool for a predetermined time. Open.

As described above, the outer frame body 1' in which the upper frame portion 11 and the lower frame portion 12'' are integrated is formed, and the medical cap 10' according to the present embodiment is obtained.

(Other Matters)
In each of the embodiments described above, the inner wall of the lower frame portion has been described as an example in which the shape thereof is substantially plate-like. However, the invention is not limited to this aspect. For example, as shown in FIGS. 13(a) to 13(c), a chamfered portion may be employed on the outer peripheral edge portion of the tip of the inner wall (the peripheral edge portion on the wall surface facing the outer wall). . By providing the chamfered portion, it is possible to facilitate the flow between the inner wall and the outer wall of the molten resin of the constituent material of the upper frame portion, which is poured into the mold when molding the upper frame portion. 13A and 13B are enlarged cross-sectional views showing the chamfered portion provided on the outer peripheral edge portion of the tip of the inner wall. FIG. represents the case where the chamfered portion is the C surface, and FIG. 4(c) represents the case where the chamfered portion is the R surface.

Here, the chamfered portion of the inner wall 61 shown in FIG. Although the height h of the slope on the slope surface 62 is not particularly limited, it is usually 0.2 mm to 3 mm. Also, the width w1 of the slope of the slope surface 62 is not particularly limited, but is usually 0.3 mm to 2 mm. Furthermore, the slope angle θ of the slope surface 62 is not particularly limited, but is usually 10° to 85°.

The chamfered portion of the inner wall 63 shown in FIG. A substantially flat flat surface 65 is provided at the top of the inner wall 63 . The chamfered length l of the C surface 64 is preferably within the range of 0.1 mm to 1.9 mm, more preferably within the range of 0.15 mm to 1 mm, and particularly preferably within the range of 0.25 mm to 0.5 mm. In addition, the width w2 of the flat surface 65 (the width of the cross section perpendicular to the wall surface of the inner wall 63) is preferably in the range of 0.1 mm to 1.9 mm, more preferably in the range of 0.15 mm to 1 mm. , 0.25 mm to 0.5 mm.

The chamfered portion of the inner wall 66 shown in FIG. The curvature radius r of the R surface 67 is preferably within the range of 0.3 mm to 2 mm, more preferably within the range of 0.5 mm to 1 mm, and particularly preferably within the range of 0.25 mm to 0.5 mm. Also in the inner wall 66 , a substantially flat flat surface 65 is provided at the top of the inner wall 63 . The width w2 of the flat surface 65 is as described above.

Further, as shown in FIG. 14, the inner wall 14 is arranged so that an arbitrary angle is formed between the end face 71 and the standing surface 72 of the annular frame portion 16 on which the inner wall 14 stands. (The same applies to the inner walls 61, 63, 66 described above.). FIG. 14 is a perspective view schematically showing how the inner wall 14 is erected on the annular frame portion 16. As shown in FIG. As a result, the inner wall 14 can be tilted further toward the elastic stopper 2 compared to, for example, the case where the corner R is provided between the end surface 71 of the inner wall 14 and the erected surface 72 of the annular frame portion 16 . can be made easier. As a result, the pressing force can be efficiently transmitted to the elastic stopper 2, and the holding force and restoring force against needle removal and the resealing property after needle removal can be further improved. The angle α between the end surface 71 and the standing surface 72 is usually less than 180°, preferably 90° to 145°, more preferably 91° to 115°.

Further, in each of the embodiments described above, the method of manufacturing the medical cap has been described by taking as an example the case where the protrusion is in the form of the ring-shaped protrusion 44 . However, the invention is not limited to this aspect. For example, it is also possible to employ those having various projections shown in FIGS. 15(a) to 15(c). That is, a second upper mold 51 (FIG. 1A) having a cylindrical protrusion 54 and a second upper mold 52 having a concave protrusion 55 (FIG. 1B) ), and a second upper mold 53 (FIG. 4(c)) having a protruding portion 56 whose central portion is curved and swollen with a predetermined curvature. In addition, in the case of the second upper mold 52 shown in FIG. It is preferable that a space is formed to accommodate the bulge of the elastic plug body 2 on the needle puncture surface 21 side.

Further, in each embodiment, an example in which the common lower mold 41 is provided with the concave portion 46 has been described. However, the invention is not limited to this embodiment. For example, in order to prevent the liquid contact surface 22 side of the elastic stopper 2 from being deformed into a convex shape, a structure in which the liquid contact surface 22 abuts when the second upper mold 43 and the common lower mold 41 are closed. A common lower mold with a base portion of . As a result, a medical cap can be manufactured in which the elastic plug is held in a state where only the needle sticking surface 21 side is deformed into a convex shape.

1 outer frame 2 elastic plugs 10, 10' medical cap 11 upper frame 12 lower frame 13 annular walls 14, 61, 63, 66 inner wall 15 gap 16 annular frame 17 placing portion 17a annular protrusion Part 18 Annular frame 19 External wall 20 Opening 21 Needle puncture surface (upper surface)
22 Wetted surface (lower surface)
23 side peripheral portion 23a engaged portion 24 peripheral edge portion 25 stepped portion 26 peripheral edge portion 27 engaged portion 28 pressing portion 41 common lower mold 42, 42' first upper mold 42a gate 43 second upper mold 43a gate 44 Ring-shaped projection 45 Engagement portion 46 Recessed portion 47 Molten resin 51-53 Second upper mold 54-56 Projection 62 Inclined surface (chamfered portion)
64 C surface (chamfered part)
65 flat surface 67 R surface (chamfered portion)
71 End surface 72 Standing surface

Claims (15)

A medical cap comprising an elastic plug and an outer frame comprising at least an upper frame supporting a peripheral portion of the elastic plug from the upper side and a lower frame supporting the peripheral edge of the elastic plug from the lower side,
The lower frame portion includes an inner wall that surrounds and accommodates a plurality of the elastic plugs, an outer wall that surrounds the inner wall, and an annular frame portion in which the inner wall and the outer wall are erected. and
the upper frame portion has an annular wall that presses the inner wall and the elastic plug in the gap between the inner wall and the outer wall;
The inner wall is welded at the contact surface with the annular wall and is not welded with the elastic plug,
The annular wall is welded to the elastic plug body in the gaps between the plurality of inner walls, and is welded to the contact surface of the outer wall,
A corner having an arbitrary angle is formed between an end surface of the inner wall facing the adjacent inner wall and a standing surface of the annular frame on which the inner wall is erected. ,
An opening is provided on the inner periphery of the annular frame portion of the lower frame portion so as to protrude outward,
Furthermore, an engaged portion is provided on the inner peripheral surface of the opening,
After molding the lower frame portion using the first upper mold and the common lower mold, the engaged portion is formed when the first upper mold and the common lower mold are opened. A medical cap for preventing the lower frame from coming into close contact with the first upper mold by engaging with the common lower mold. A mounting portion for mounting the elastic stopper in the lower frame portion is provided with an annular ridge,
2. The medical cap according to claim 1, wherein said annular protrusion is embedded on the lower surface side of said peripheral portion of said elastic stopper. 3. The medical cap according to claim 1 or 2, wherein the upper surface of said elastic stopper, or a portion of the upper and lower surfaces excluding the peripheral edge portion, is deformed into a convex shape. The elastic plug has a stepped portion on the peripheral edge of its upper surface,
The medical cap according to any one of claims 1 to 3, wherein the upper frame portion has a pressing portion for pressing the stepped portion. The medical cap according to any one of claims 1 to 4, wherein the height position of the outer wall is higher than the upper surface of the elastic stopper. The height position of the inner wall is equal to or higher than the height position of the side peripheral portion of the elastic plug body, which is the surface in contact with the inner wall , and is equal to or lower than the upper surface of the elastic plug body. 6. The medical cap according to any one of 5. The medical cap according to any one of claims 1 to 6, wherein a chamfered portion is provided on the outer peripheral edge portion at the tip of the inner wall. A method for manufacturing a medical cap having an elastic plug and an outer frame including at least an upper frame supporting a peripheral portion of the elastic plug from the upper side and a lower frame supporting the peripheral edge of the elastic plug from the lower side. ,
Using a first upper mold and a common lower mold, an inner wall surrounding and accommodating a plurality of the elastic plugs, an outer wall surrounding the inner wall, and the inner wall and the outer wall standing upright are provided. molding the lower frame portion with an annular frame portion that is
a step of placing the elastic plug with its upper surface facing upward inside the inner wall of the lower frame;
By using a second upper mold that can form a cavity for molding the upper frame portion when combined with the common lower mold, the inner wall and the elastic plug are formed in the gap between the inner wall and the outer wall. molding the upper frame with an annular wall that presses against the body;
The inner wall is welded at the contact surface with the annular wall and is not welded with the elastic plug,
The annular wall is welded to the elastic plug body in the gaps between the plurality of inner walls, and is welded to the contact surface of the outer wall,
In the inner wall and the annular frame, there are arbitrary It is molded so that an angled corner is formed,
An opening is formed on the inner periphery of the annular frame portion of the lower frame portion so as to protrude outward,
Further, an engaged portion is formed on the inner peripheral surface of the opening,
The engaged portion is formed when the first upper mold and the common lower mold are opened after molding the lower frame portion using the first upper mold and the common lower mold. and (2) engaging with the common lower mold to prevent the lower frame from coming into close contact with the first upper mold. In the step of forming the upper frame portion, the second upper mold having a protrusion having a diameter smaller than the diameter of the upper surface of the elastic plug is used,
When the common lower mold and the second upper mold are closed, the protrusion presses at least the peripheral edge of the upper surface of the elastic stopper, thereby forming a convex shape at the center of the upper surface. 9. The method of manufacturing a medical cap according to claim 8 , wherein the upper frame portion is formed by injecting a molten resin into the cavity while deforming the upper frame portion. The step of forming the lower frame portion is a step of forming the lower frame portion having a mounting portion for mounting the elastic plug and an annular ridge portion for pressing the elastic plug. and
In the forming step of the upper frame portion, the projection presses at least the peripheral portion of the upper surface of the elastic plug, so that the annular protrusion is embedded in the lower surface side of the peripheral portion of the elastic plug. 10. The method for manufacturing the medical cap according to claim 9, which is carried out in a closed state. using, as the common lower mold, one having a recess having a smaller diameter than the diameter of the lower surface of the elastic stopper,
When the common lower mold and the second upper mold are closed, the projection presses at least the peripheral edge of the upper surface of the elastic stopper, thereby forming a convex shape at the center of the lower surface. 11. The method of manufacturing a medical cap according to claim 9 or 10 , wherein the upper frame portion is molded by injecting a molten resin into the cavity in a state of deformation. As the elastic stopper, an elastic stopper having a stepped portion on the peripheral edge of its upper surface is used,
In the step of forming the upper frame portion, the upper frame portion having a pressing portion that presses the stepped portion is formed by pressing the peripheral edge portion of the upper surface of the elastic plug body excluding the stepped portion with the projection portion. The method for manufacturing a medical cap according to any one of claims 9 to 11, which is a step of The step of forming the lower frame portion is a step of forming the lower frame portion such that the height position of the outer wall is equal to or higher than the upper surface of the elastic plug. A method for manufacturing the described medical cap. In the step of forming the lower frame portion, the height position of the inner wall of the elastic plug body is equal to or higher than the height position of the side peripheral portion, which is the surface in contact with the inner wall, of the elastic plug body. 14. The method for manufacturing a medical cap according to any one of claims 8 to 13, wherein the step of forming the lower frame portion below the upper surface of the body. 15. The process according to any one of claims 8 to 14 , wherein the step of forming the lower frame portion is a step of forming the inner wall having a chamfered portion on the outer peripheral edge portion at the tip of the inner wall. A method for manufacturing the described medical cap.

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