JP7171037B2 - Transfusion member and manufacturing method thereof - Google Patents

Description

TECHNICAL FIELD The present invention relates to a transfusion member and a manufacturing method thereof, and more particularly, a powder formulation, a freeze-dried formulation, or the like contained in a drug container such as a vial is dissolved in a liquid at the time of use, or diluted with the liquid. The present invention relates to a transfusion member having a double-ended needle that allows the injection to be performed and a method for manufacturing the same.

When administering a drip injection (infusion) to a patient, a drug such as a powder formulation or a freeze-dried formulation contained in a drug container such as a vial is dissolved in a liquid such as physiological saline, glucose solution, or pure water, or A chemical solution is obtained by diluting it with the liquid. At that time, a transfusion member having a double-ended needle is used as a device for communicating a vial bottle containing a drug and a container such as a bag containing a liquid.

As the transfusion member, for example, Patent Document 1 described later includes a tubular body, a double-ended needle, a first inner tubular body that can slide within the tubular body, and a first inner tubular body that can slide within the first inner tubular body. A second inner cylinder is disclosed. According to this transfusion member, the first locking mechanism for restricting the sliding movement of the first inner cylinder is provided between the tubular body and the first inner cylinder. and the second inner cylindrical body, a second locking mechanism for restricting the sliding movement of the second inner cylindrical body is provided. When connecting the first container and the second container via the transfusion member, the first container is not inserted into the second inner cylindrical body, and the first locking mechanism and the second By pushing the opening of the first container toward the second inner cylinder in a state where the sliding movement of the first inner cylinder and the second inner cylinder is restricted by the locking mechanism, the first puncture is performed. A needle is pierced through the elastic obturator membrane. In addition, the second puncture needle is caused to pierce the sealing membrane by releasing the locking by the first locking mechanism and the second locking mechanism and pushing the first inner cylindrical body toward the second container. The first puncture needle and the second puncture needle communicate internally. Therefore, in Patent Document 1, it is supposed that the drug can be dissolved in the dissolving liquid while preventing the liquid from leaking to the outside.

Here, when connecting the first container and the second container via the transfusion member of Patent Document 1, the transfusion member should have a certain or more mechanical strength in order to maintain its shape. is required. However, in the case of a cylindrical body with high mechanical strength, it is not easy for the second puncture needle to penetrate through the bottom portion of the cylindrical body, resulting in reduced needle stickability. As a result, there is a problem that the handleability and workability of the transfusion member are deteriorated.

JP 2015-77217 A

SUMMARY OF THE INVENTION The present invention has been made in view of the above problems, and an object thereof is to provide a transfusion member excellent in handleability and workability while maintaining mechanical strength, and a method for manufacturing the same.

In order to solve the above problems, the transfusion member according to the present invention comprises a tubular body, and a communication part that is housed inside the tubular body and is slidable along the inner surface of the tubular body. wherein the communication part comprises a plate-like part and a first puncture needle erected toward the opening of the cylindrical body at the center of one surface of the plate-like part. and a second puncture needle erected toward the bottom of the cylindrical body at the center of the other surface of the plate-shaped part, and the bottom of the cylindrical body has a hole on the bottom. A bottom complementary portion that closes from the side is provided, and the bottom complementary portion includes a base portion and a thin portion that is provided in the center of the base portion and can be penetrated by the second puncture needle, The bottom complementary portion is joined to the bottom portion of the cylindrical body by thermal welding at the contact surface with the bottom portion of the cylindrical body.

According to the above configuration, in the cylindrical body capable of accommodating therein the communicating portion including the first puncture needle and the second puncture needle, etc., the bottom complementary portion capable of closing the hole portion of the bottom from the outside. is provided. For example, even if the cylindrical body is made of a resin material with high mechanical strength (rigidity), the bottom complementary portion can be made of a resin material different from the cylindrical body and having low mechanical strength. It is possible to prevent difficulty in penetrating the second puncture needle through the thin-walled portion. In addition, when the cylindrical body is made of, for example, a resin material having optical transparency, it is possible to improve the visibility from the outside of the cylindrical body with respect to the connecting portion accommodated inside. As a result, it is possible to provide a transfusion member that is excellent in handleability and workability when used.

In addition, since the bottom complementary portion in the above configuration is joined to the bottom portion by heat welding at the contact surface between the base portion and the bottom portion of the cylindrical body, for example, the opening portion of the cylindrical body is sealed or the like. In the case of sealing, the communicating portion can be housed in the cylindrical body in a sealed state until immediately before use. As a result, it is possible to prevent foreign matter from entering the interior of the cylindrical body and to maintain the sterilization state.

In the above-described configuration, an anchoring portion may be provided on a contact surface of the base portion of the bottom complementary portion with the bottom portion of the tubular body to reinforce the joint with the bottom portion. preferable. As a result, for example, even when the second puncture needle penetrates the thin portion of the bottom complementary portion, it is possible to prevent the bottom complementary portion from falling off from the cylindrical body.

A plurality of the anchoring portions are provided in a region other than the region where the thin portion is provided on the base portion, and are arranged on the same circumference so as to be equidistant from each other. preferably. By providing a plurality of anchoring portions on the same circumference of the base portion at equal intervals, the joint strength between the base portion and the bottom portion of the cylindrical body can be made uniform, and the bottom complementary portion can be formed. Falling off from the bottom of the cylindrical body can be further prevented.

In the above configuration, a portion of the anchoring portion is supported by a support portion erected in a substantially vertical direction with respect to the base portion, and a portion not supported by the support portion is the base portion. It is preferable to extend in a direction parallel to the surface of the base portion and in a direction other than the center direction of the base portion while being separated from the base portion. A part of the anchoring part is supported by a support part that stands upright in a substantially vertical direction with respect to the base part, so that the part that is not supported by the support part extends in a state separated from the base part. can be made With such a structure, for example, when a cylindrical body is molded by inserting the bottom complementary portion into a mold, molten resin, which is a constituent material of the cylindrical body, is used to separate the anchoring portion and the base portion. can flow into the gaps between As a result, a pouring member having excellent bonding strength at the contact surface between the bottom complementing portion and the bottom of the cylindrical body can be obtained.

Further, by extending the portion of the anchoring portion that is not supported by the support portion in a direction parallel to the surface of the base portion and in a direction other than the center direction of the base portion, the molding is performed. The mold can be slid in a direction away from the center of the base part when releasing the bottom complementary part from the mold, and the mold can be easily opened.

Further, in the above configuration, it is preferable that the bottom complementary portion and the bottom portion of the cylindrical body are joined by heat-melting at least the anchoring portion. As a result, the bonding strength between the bottom complementary portion and the bottom portion of the cylindrical body can be further improved.

In the above configuration, a tubular puncture needle guide portion that guides penetration of the thin portion by the second puncture needle is provided in the center portion of the bottom complementary portion, and the bottom surface of the puncture needle guide portion is provided with the thin portion, and the puncture needle guide portion preferably protrudes inward of the tubular body from a hole in the bottom portion of the tubular body. A puncture needle guide portion protruding inward from a hole in the bottom portion of the cylindrical body is provided in the central portion of the bottom complementary portion, and a thin portion is provided on the bottom surface of the puncture needle guide portion, thereby making the second puncture needle thin. It is possible to reliably pierce the part.

In the above configuration, a substantially truncated conical reinforcing portion tapering toward the inside of the tubular body is provided at the central portion of the base portion, and the puncture needle guide portion is provided with the At the center of the reinforcing portion, the outer surface of the thin-walled portion protruding inwardly and outwardly of the cylindrical body and provided on the bottom surface of the puncture needle guide portion extends outside the base portion. It is preferable that the height position is higher than the side surface. Since the reinforcement portion has a substantially truncated cone shape that tapers inwardly of the cylindrical body, the mechanical strength of the puncture needle guide portion can be improved when the second puncture needle is pierced through the thin portion. Further, since the outer surface of the thin portion is higher than the outer surface of the base portion, it is possible to prevent the outer surface of the thin portion from coming into contact with the mouth of the container or the like.

In the above configuration, it is preferable that the inner surface of the thin portion is coated with a lubricant that reduces penetration resistance when the second puncture needle penetrates the thin portion. By applying the lubricant to the inner surface of the thin-walled portion, it is possible to reduce the penetration resistance when the second puncture needle penetrates the thin-walled portion. As a result, it is possible to provide a transfusion member that is even more excellent in handleability during use.

In order to solve the above-described problems, the method for manufacturing a transfusion member of the present invention includes a tubular body and a communicating member that is housed inside the tubular body and is slidable along the inner surface of the tubular body. a plate-shaped portion; and a first puncture needle erected toward the opening of the cylindrical body at the center of one surface of the plate-shaped portion. , a communicating portion forming step of forming the communicating portion including a second puncture needle erected toward the bottom portion of the cylindrical body at the center portion on the other surface of the plate-shaped portion; and a base portion. and a bottom complementary portion forming step for forming a bottom complementary portion having a thin portion that is provided in the center of the base portion and can be penetrated by the second puncture needle; A cylindrical body molding step of molding a cylindrical body to which the bottom complementary portion is joined by heat welding by insert molding or two-color molding, and the communicating portion is formed inside the cylindrical body integrated with the bottom complementary portion. and an assembling step of housing the transfusion member and assembling the transfusion member.

According to the above configuration, first, after molding the bottom complementary portion (bottom complementary portion molding step), the cylindrical body to which the bottom complementary portion is joined by heat welding is molded by insert molding or two-color molding (cylinder shape forming process). Furthermore, the transfusion member of the present invention is manufactured by housing the communicating portion formed in the communicating portion forming step inside the cylindrical body integrated with the bottom complementary portion and assembling the transfusion member (assembling step). do. With such a manufacturing method, by molding the bottom complementary portion with a resin material having low mechanical strength, it is possible to relatively easily penetrate the thin portion with the second puncture needle. In addition, by forming the tubular body from a resin material having high mechanical strength, it is possible to suppress deformation of the transfusion member even when it is used. Further, when the cylindrical body is molded from a resin material having light transmission properties, it is possible to improve the visibility from the outside of the cylindrical body with respect to the connecting portion accommodated inside. As a result, it is possible to manufacture a transfusion member with good handleability and workability during use.

Further, in the above configuration, since the cylindrical body is molded with the bottom complementing part inserted into the pair of molds, a pouring member in which the bottom complementary part is thermally welded to the bottom of the cylindrical body can be obtained. As a result, the bonding strength between the bottom complementary portion and the bottom portion of the cylindrical body can be improved, and the falling off of the bottom complementary portion can be prevented.

In the above configuration, the step of forming the complementary bottom portion includes the bottom portion having an anchoring portion for reinforcing the joint with the bottom portion in a portion other than the thin portion provided in the center of the base portion. It is preferable that it is a step of molding the complementary portion. As a result, for example, even when the second puncture needle penetrates the thin portion of the bottom complementary portion, it is possible to manufacture a transfusion member that can prevent the bottom complementary portion from falling off from the cylindrical body. .

In the above configuration, a plurality of the anchoring portions of the bottom complementary portion formed in the bottom complementary portion molding step are provided in a region other than the region where the thin portion is provided on the base portion. and arranged on the same circumference so as to be equidistant from each other. By providing a plurality of anchoring portions on the same circumference of the base portion at equal intervals, the joint strength between the base portion and the bottom portion of the cylindrical body can be made uniform, and the bottom complementary portion can be It is possible to manufacture a transfusion member that can further prevent the drop from the bottom of the tubular body.

In the above configuration, the anchoring portion of the bottom complementary portion molded in the bottom complementary portion forming step is partly erected in a substantially vertical direction with respect to the base portion. A portion that is supported by a support portion and is not supported by the support portion extends in a direction parallel to the surface of the base portion and in a direction other than the center direction of the base portion. It preferably has a shape that extends away from the portion. A part of the anchoring part is supported by a support part that stands upright in a substantially vertical direction with respect to the base part, so that the part that is not supported by the support part extends in a state separated from the base part. can be made As a result, in the cylindrical body molding process, when the molten resin is injected into the cavity to mold the cylindrical body, the molten resin can flow into the gap between the anchoring portion and the base portion. , a transfusion member having excellent bonding strength at the contact surface between the bottom complementary portion and the bottom portion of the cylindrical body can be produced.

Further, by extending the portion of the anchoring portion that is not supported by the support portion in a direction parallel to the surface of the base portion and in a direction other than the center direction of the base portion, the molding is performed. The mold can be slid in a direction away from the center of the base part when releasing the bottom complementary part from the mold, and the mold can be easily opened.

In the above configuration, in the cylindrical body forming step, the anchoring portion of the bottom complementary portion is thermally melted by the heat of the molten resin, and the bottom complementary portion is joined by heat welding to form the tubular shape. It is preferably a step of shaping the body. As a result, it is possible to obtain a transfusion member in which the bonding strength between the bottom complementary portion and the bottom portion of the cylindrical body is further improved.

In the above configuration, a cylindrical puncture needle guide portion for guiding penetration of the thin portion by the second puncture needle is provided at the center portion of the bottom complementary portion formed in the bottom complementary portion forming step. Further, the thin portion is provided on the bottom surface of the puncture needle guide portion, and the puncture needle guide portion extends from the hole in the bottom portion of the cylindrical body formed in the cylindrical body forming step, It is preferable that it protrudes inward of the cylindrical body. By providing a tubular puncture needle guide part for guiding penetration of the thin part by the second puncture needle so as to protrude inward from the hole in the bottom part of the tubular body, the second puncture needle is thinned. It is possible to produce a transfusion member that can be reliably pierced into the part.

In the bottom complementary portion formed in the bottom complementary portion forming step, a substantially truncated conical reinforcing portion tapered toward the inside of the cylindrical body is provided at the center of the base portion. , the puncture needle guide portion is provided at the center of the reinforcing portion so as to protrude inwardly and outwardly of the cylindrical body formed in the cylindrical body forming step, and the puncture needle guide portion of the It is preferable that the outer surface of the thin portion provided on the bottom surface is higher than the outer surface of the base portion. The mechanical strength of the puncture needle guide section can be improved by providing a substantially truncated conical reinforcing section that tapers toward the inside of the cylindrical body at the central section of the base section. As a result, it is possible to obtain a transfusion member capable of preventing deformation of the base portion when the thin portion is pierced with the second puncture needle. In addition, since the bottom complementary portion and the cylindrical body are formed so that the outer surface of the thin portion is higher than the outer surface of the base portion, the outer surface of the thin portion does not overlap with the mouth of the container. Transfusion members can be made that can be prevented from touching.

In the above configuration, prior to the assembling step, the inner surface of the thin portion of the cylindrical body formed in the cylindrical body forming step is used to pierce the thin portion with the second puncture needle. It is preferable to perform an application step of applying a lubricant that reduces piercing resistance. As a result, it is possible to reduce the piercing resistance when the second puncture needle penetrates the thin-walled portion, and manufacture a transfusion member that is even more excellent in handleability during use.

The present invention has a configuration in which a bottom supplementary portion thermally welded to the contact surface is provided at the bottom of a cylindrical body that houses a communication portion having a first puncture needle, a second puncture needle, and the like. As a result, for example, even when a cylindrical body having a large mechanical strength (rigidity) is used, the bottom complementary portion is made of a resin material having a lower mechanical strength than that of the cylindrical body. It is possible to prevent difficulty in penetrating the thin portion of the bottom complementary portion due to As a result, it is possible to provide a transfusion member excellent in handleability and workability and a method for producing the same.

BRIEF DESCRIPTION OF THE DRAWINGS It is a cross-sectional schematic diagram showing the outline of the drug mixing kit which concerns on embodiment of this invention. It is a cross-sectional schematic diagram showing schematic structure of the 1st container which concerns on the said embodiment. It is a cross-sectional schematic diagram showing schematic structure of the 2nd container in the said medicine mixing kit. Fig. 2 is a schematic cross-sectional view showing a schematic configuration of a transfusion member in the drug mixing kit; FIG. 1(a) is a schematic cross-sectional view showing a schematic configuration of a cylindrical body provided with a bottom complementary portion in the transfusion member, and FIG. It is a diagram. 4(a) and 4(b) are enlarged schematic cross-sectional views showing the inner surface of the lower cylindrical body of the cylindrical body. FIG. 1(a) is a perspective view showing a schematic configuration of the bottom complementary portion before being thermally welded to the lower cylindrical body, and FIG. 1(b) is a side view showing the bottom complementary portion. 1A is a cross-sectional view of the bottom complementary portion in the vertical direction, and FIG. 1B is a cross-sectional view showing the main part of the bottom complementary portion. 1A is a plan view showing a schematic configuration of the bottom complementary portion, and FIG. 1B is a plan view showing a schematic configuration of an anchoring portion in the bottom complementary portion. FIG. 1(a) is a perspective view showing a schematic configuration of a communication portion in the medicine mixing kit, and FIG. 1(b) is a side view showing the communication portion. FIG. 4 is a partially enlarged view showing a main part of the communicating part of the transfusion member according to the embodiment; (a) and (b) of the figure are partial enlarged views showing the essential parts of the first puncture needle and the second puncture needle in the transfusion member, and (c) of the same figure is the first puncture needle and the second puncture needle. 1 is a partially enlarged cross-sectional view showing a main part in a side view of FIG. FIG. 3 is a schematic partial cross-sectional view showing an outline of a drug mixing kit according to another embodiment of the present invention;

(drug mixture kit)
A drug mixing kit according to this embodiment will be described below. FIG. 1 is a schematic cross-sectional view showing an outline of a drug mixing kit according to this embodiment.

As shown in FIG. 1, the drug mixing kit 1 of the present embodiment includes at least a second container 20 containing a liquid and a transfusion member 30 having a double-ended needle. It is a kit for mixing the medicine contained in the second container with the liquid contained in the second container via the transfusion member 30 .

[First container]
First, the first container 10 will be described with reference to FIG. FIG. 2 is a schematic cross-sectional view showing a schematic configuration of the first container 10 according to this embodiment.

As shown in FIG. 2, the first container 10 contains a drug (not shown) such as a powder formulation or a (freeze) dried formulation. As shown in FIG. 2 , the first container 10 includes a first container body 101 having a mouth portion 102 and an elastic stopper 103 . The opening 102 has a substantially circular shape. A neck portion 107 is provided between the first container main body portion 101 and the mouth portion 102 . The elastic stopper 103 is provided so as to seal the opening 102 . The elastic plug 103 has a cylindrical overall shape, and a needle puncture surface 104 is provided with a recess 105 in the central portion thereof. As a result, the central portion of the elastic plug 103 is thinner than the peripheral portion, forming a thin portion. Furthermore, the concave portion 105 corresponds to a needle sticking position of a first puncture needle, which will be described later. Therefore, when the hardness of the elastic plug 103 is high, it is possible to prevent difficulty in penetrating the elastic plug 103 with the first puncture needle.

The first container main body 101 is not particularly limited, and for example, a glass container or a resin container can be used.

The material of the elastic plug 103 is not particularly limited, and examples thereof include rubber and thermoplastic elastomer resin. 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 resin is not particularly limited, and examples thereof include olefin-based, styrene-based, polyurethane-based, polyester-based, polyvinyl chloride-based, polybutadiene-based, polyamide-based, and polyurethane-based resins. Among them, thermoplastic elastomers (SEBS, SEPS, HSBR, SEBR, CEBC) obtained by hydrogenating conjugated diene thermoplastic elastomers are preferable. These thermoplastic elastomer resins may be used alone or in combination of two or more.

The characteristics of the elastic plug 103 are not particularly limited. However, regarding the hardness of the elastic plug 103, when the first puncture needle is pressed, the elastic plug 103 does not penetrate, and the second puncture needle penetrates the thin portion at the bottom of the cylindrical body and the second container. It suffices that the film portion can be penetrated sequentially. The hardness of the elastic plug 103 is preferably A30-70, more preferably A40-60, as measured by the JIS K6253 method.

The thickness of the elastic plug 103 is also not particularly limited. However, by pressing the first puncture needle, the elastic stopper 103 does not penetrate, and the second puncture needle (to be described later) sequentially penetrates the thin portion of the bottom of the cylindrical body and the membrane of the second container. It is preferable to set so that

[Second container]
Next, the second container 20 will be explained based on FIG. FIG. 3 is a schematic cross-sectional view showing a schematic configuration of the second container 20 in the drug mixing kit 1 of this embodiment.

As shown in Figure 3, the second container 20 contains a liquid that mixes with the drug to dissolve or dilute it. The second container 20 includes a second container body portion 201 and a membrane portion 202 . The second container body 201 has a communication port 204 at one end 203 on the connection side with the transfusion member 30 . In addition, an extraction portion 206 is provided at the other end portion 205 opposite to the one end portion 203 . The film portion 202 is provided so as to seal the communication port 204 . Further, the film portion 202 is provided so as to be located inside the outer peripheral surface of the communication port 204 . Furthermore, a flange portion 207 is provided on the peripheral portion of the one end portion 203 to enable connection with the transfusion member 30 .

The extractor 206 is provided with a medical cap that closes it. In addition, medical caps are provided with other elastic stoppers. This makes it possible to take out the drug solution from the take-out part 206 by piercing the other elastic plug with the puncture needle.

The second container main body 201 is not particularly limited, and examples thereof include a flexible material such as an infusion bag. Moreover, the material of the second container body 201 is not particularly limited, and examples thereof include synthetic resins such as polyethylene, polyester, and polypropylene.

The film portion 202 is preferably made of the same material as the second container body portion 201, but may be made of a different material such as rubber or thermoplastic elastomer resin. The thickness of the membrane part 202 is at least within a range in which the elastic plug 103 is not penetrated when the elastic plug 103 presses the first puncture needle, which will be described later, to penetrate the thin portion with the second puncture needle. preferably set. Moreover, the liquid is not particularly limited, and examples thereof include physiological saline, glucose solution, pure water, and the like.

[Transferred parts]
Next, the transfusion member 30 will be described with reference to FIG. FIG. 4 is a schematic cross-sectional view showing the schematic configuration of the transfusion member 30 in the drug mixing kit 1 of the present embodiment.

The transfusion member 30 has a function of mixing the drug contained in the first container 10 and the liquid contained in the second container 20 . As shown in FIG. 4 , the transfusion member 30 includes a tubular body 301 and a communicating portion 302 that is housed inside the tubular body 301 and is slidable along the inner surface of the tubular body 301 . include.

As shown in FIG. 5A, the cylindrical body 301 has a bottomed cylindrical shape as a whole, and a side wall thereof is provided with a stepped portion 311 along the entire circumference. An upper cylindrical body 312 is provided on the upper side (first container 10 side) of the stepped portion 311 , and a lower cylindrical body 313 is provided on the lower side (second container 20 side). FIG. 5(a) is a schematic cross-sectional view showing a schematic configuration of the cylindrical body 301 of this embodiment, and FIG. It is a cross-sectional schematic diagram showing.

The material of the cylindrical body 301 is not particularly limited, and examples thereof include synthetic resins such as polypropylene, polyethylene, ABS (acrylonitrile butadiene styrene) resin, polycarbonate, and polystyrene.

The upper tubular body 312 is provided with an opening 314 for receiving the first container 10 . Also, the upper tubular body 312 has a larger inner diameter and outer diameter than the lower tubular body 313 . It is preferable that the diameter of the upper cylindrical body 312 is at least greater than the diameter of the first container body 101 of the first container 10 . Thereby, the insertion of the first container 10 can be facilitated. Furthermore, the depth of the upper cylindrical body 312 is not particularly limited, but at least the height (length) of a first puncture needle of a double-ended needle described later and the height of a holding portion that holds the inserted state of the first container 10 is preferably equal to or greater than The opening 314 of the upper tubular body 312 is preferably sealed with a film or the like before the transfusion member 30 is used, so that the inside of the tubular body 301 is kept sterile.

On the inner surface of the lower cylindrical body 313 and near the lower portion of the stepped portion 311, as shown in FIG. is provided (details of the plate-like portion will be described later). 6(a) and 6(b) are enlarged schematic cross-sectional views showing the inner surface of the lower tubular body 313 of this embodiment. The first restricting portion 315 has a structure in which a concave portion is annularly provided on the inner surface of the lower tubular body 313 . Thereby, the first restricting portion 315 can restrict the communication portion 302 from sliding toward the bottom on the inner surface of the lower tubular body 313 . Also, it is possible to prevent the communicating portion 302 from falling off from the cylindrical body 301 . The form of the first restricting part is not limited to this. For example, the first restricting part may have a structure in which a convex part is annularly provided on the inner surface of the lower cylindrical body 313 .

Further, a plurality of third restricting portions 318 are provided on the inner surface of the lower cylindrical body 313 and near the lower portion of the stepped portion 311, as shown in FIG. 6(b). The third restricting portion 318 has a structure in which a convex portion is annularly provided on the inner surface of the lower tubular body 313 . Also, the third restricting portion 318 is provided at a position corresponding to the riding portion 337 (details of which will be described later) provided in the communicating portion 302 . As a result, it is possible to prevent the communicating portion 302 from sliding toward the upper tubular body 312 and falling off the tubular body 301 . In addition, the present invention is not limited to this as the form of the third restricting portion. For example, the formation positions of the plurality of protrusions may not be equidistant. Further, the third restricting portion may have a structure in which a convex portion is annularly provided around the entire circumference of the inner surface of the lower tubular body 313 .

Further, as shown in FIG. 6, a plurality of second restricting portions 316 are provided on the inner surface of the lower cylindrical body 313 and closer to the bottom portion 320 than the first restricting portion 315 is. The second restricting portion 316 has a structure in which convex portions are annularly provided at equal intervals on the inner surface of the lower tubular body 313 . As a result, the second restricting portion 316 can restrict the communicating portion 302 from sliding toward the opening portion 314 on the inner surface of the lower cylindrical body 313, and the first container 10 and the second container 10 can be separated from each other by the double-ended needle. It is possible to maintain the state of communication with the second container 20 . In addition, the present invention is not limited to this as the form of the second restricting portion. For example, the formation positions of the plurality of protrusions may not be equidistant. Further, the second restricting portion may have a structure in which a convex portion is annularly provided around the entire circumference of the inner surface of the lower tubular body 313 .

Further, a slide guide portion 317 formed of a band-shaped concave portion is provided on the inner surface of the lower cylindrical body 313 from the stepped portion 311 to the bottom portion 320 (see FIG. 5). The slide guide portion 317 can be fitted with a projecting portion provided on the outer peripheral edge of the plate-like portion of the communicating portion 302 (details of the projecting portion will be described later). The upper end of the slide guide portion 317 is preferably positioned below the stepped portion 311 (in the direction toward the bottom portion 320) at the annular first restricting portion 315. As shown in FIG. Further, the lower end of the slide guide portion 317 communicates so that the second puncture needle can sufficiently penetrate the film portion 202 of the second container 20 and the thin portion (details of which will be described later) of the bottom portion 320 of the cylindrical body 301. It is preferable that the portion 302 is provided at a position where it can slide.

At least one slide guide portion 317 is preferably provided. In this embodiment, three slide guide portions 317 are provided to enable stable sliding movement of the communication portion 302 inside the lower cylindrical body 313 .

As shown in FIGS. 5(a) and 5(b), the bottom portion 320 of the lower cylindrical body 313 is provided with a bottom complementary portion 321 that closes the hole portion 319 from the outside. This bottom supplementary portion 321 is provided by being joined to the contact portion of the bottom portion 320 from the outside of the lower cylindrical body 313 by thermal welding.

As shown in FIGS. 7 to 9, the bottom complementary portion 321 includes a circular base portion 322, a reinforcing portion 327 provided in the center of the base portion 322, and a reinforcing portion 327 provided in the center of the reinforcing portion 327. A second puncture needle guide portion 325 and a thin portion 323 provided on the bottom surface of the second puncture needle guide portion 325 are provided. 7A and 7B are schematic diagrams for explaining the bottom complementary portion 321, and FIG. 7A is a perspective view showing a schematic configuration before the bottom complementary portion 321 is thermally welded to the lower cylindrical body. 3B is a side view showing the bottom complementary portion 321. FIG. 8A and 8B are schematic diagrams for explaining the bottom complementary portion 321. FIG. 8A is a cross-sectional view of the bottom complementary portion 321 in the vertical direction, and FIG. It is a sectional view showing. 9A is a plan view showing a schematic configuration of the bottom complementary portion 321, and FIG. 9B is a plan view showing a schematic configuration of the anchoring portion in the bottom complementary portion 321. FIG.

At the central portion of the base portion 322 , a substantially truncated conical reinforcing portion 327 tapering toward the inside of the tubular body 301 is provided. Thereby, the mechanical strength of the second puncture needle guide portion 325 can be improved when the thin portion 323 is pierced with the second puncture needle. The thickness of reinforcing portion 327 is not particularly limited, and can be set according to the degree of mechanical strength to be imparted to puncture needle guide portion 325 . The angle θ of the slope l of the reinforcing portion 327 with respect to the horizontal plane is also not particularly limited, and can be set according to the degree of mechanical strength to be imparted to the second puncture needle guide portion 325 .

The second puncture needle guide 325 has a function of guiding the second puncture needle in order to facilitate the penetration of the thin portion 323 by the second puncture needle, and is provided at the center of the reinforcing portion 327 . The second puncture needle guide portion 325 has a cylindrical overall shape and protrudes inward from the hole portion 319 of the tubular body 301 . Second puncture needle guide 325 is provided so as to protrude outward from hole 319 as well. Furthermore, the thin portion 323 is provided so as to be the bottom surface of the second puncture needle guide portion 325 . The height H1 of the _second puncture needle guide portion 325 (the height from the back surface 326 of the base portion 322) is not particularly limited as long as it is capable of guiding the second puncture needle, and is set as appropriate. can do.

As described above, the thin portion 323 is provided so as to be the bottom surface of the second puncture needle guide portion 325 , but is thinner than the back surface 326 of the base portion 322 and the back surface 328 of the bottom portion 320 of the lower tubular body 313 . It is preferable that the height position is set inward. That is, the height H2 of the thin portion 323 (the height from the back surface 326 of the base portion 322 to the back surface 323a of the thin portion 323) is set to the extent that it does not come into contact with the membrane portion 202 at the communication port 204 of the _second container 20 at least. It is not particularly limited as long as it is spaced apart, and can be set as appropriate. Also, the thin portion 323 is thinner than the portion of the base portion 322 where the thin portion 323 is not provided. This ensures the rigidity of the bottom complementary portion 321 and prevents the mechanical strength from being excessively lowered, while facilitating the penetration of the thin portion 323 by the second puncture needle. The thickness of the thin portion 323 is preferably set within a range that allows the second puncture needle to pass through the thin portion 323 when the elastic plug 103 presses the first puncture needle. By providing the thin portion 323 in the bottom portion 320 of the lower cylindrical body 313, it is possible to keep the inside of the transfusion member 30 sterilized before use until just before use.

Lubricant is preferably applied to the inner surface of the thin portion 323 . As a result, when the second puncture needle is penetrated through the thin-walled portion 323, the lubricant comes into contact with and adheres to the outer surface of the second puncture needle, thereby reducing the penetration resistance. As a result, it is possible to provide the transfusion member 30 which is more excellent in handleability during use. The lubricant is not particularly limited, and examples thereof include silicone oil.

The bottom complementary portion 321 has an anchoring portion 324 for increasing the bonding strength with the bottom portion 320 of the cylindrical body 301 . More specifically, the anchoring portion 324 is the surface side of the base portion 322 on which the second puncture needle guide portion 325 is provided, and the second puncture needle guide portion 325 and the reinforcing portion 327 are provided. Four of them are provided in a portion other than the portion where it is located (see FIGS. 7(a), 7(b) and 9(a)). Each anchoring portion 324 is evenly arranged on the same circumference on the base portion 322 . Further, each anchoring portion 324 is provided so as to have a mirror image relationship with respect to the plane of symmetry P, as shown in FIG. 9(a).

The anchoring portion 324 is supported by a support portion 324a erected vertically with respect to the base portion 322. As shown in FIG. Further, the anchoring portion 324 is arranged in a direction other than the center direction of the base portion 322 so as to be parallel to the surface of the base portion 322 while being separated from the base portion 322 by a certain distance. Expanding and extending. The anchoring part 324 is spaced apart from the base part 322 and provided parallel to the surface of the base part 322 , so that the anchoring part 324 can be inserted into the mold to form the cylindrical body 301 . When performing the insert molding, the molten resin, which is the constituent material of the cylindrical body 301, can be made to flow into the gap between the anchoring portion 324 and the base portion 322. As shown in FIG. As a result, the bonding strength between the cylindrical body 301 and the bottom complementary portion 321 can be improved.

Since the anchoring portion 324 and the support portion 324a are melted by the heat of the molten resin when the cylindrical body 301 is insert-molded, the joint surface between the cylindrical body 301 and the bottom complementary portion 321 is shape is lost.

_The height (thickness) h1 of the anchoring portion 324 with respect to the base portion 322 is set from the viewpoint of improving the mechanical strength of the bottom portion 320 of the tubular body 301 and the bonding strength between the bottom complementary portion 321 and the bottom portion 320. preferably. Moreover, it is preferable to set the height h2 of the support portion 324a with respect to the base portion 322 from the viewpoint of improving the joint strength between the cylindrical body 301 and the _bottom portion complementary portion 321 .

In addition, it is preferable that the anchoring portion 324 expands and extends in a direction other than the center direction of the base portion 322 with respect to the support portion 324a. By expanding and extending in a direction other than the central direction of the base portion 322, the mold is slid in the outer peripheral direction of the base portion 322 when releasing the molded bottom complementary portion 321 from the mold. It becomes possible to move. As a result, the mold can be easily opened. Here, the length L of the portion of the anchoring portion 324 that is not supported by the support portion 324a is preferably equal to or smaller than the thickness D of the support portion 324a that supports the anchoring portion 324 ( See FIG. 8(b).). Accordingly, in a state in which the bottom supplementary portion 321 exists alone, the support portion 324a can ensure sufficient mechanical strength for supporting the anchoring portion 324. As shown in FIG. As a result, collapse of the anchoring portion 324 and the support portion 324a can be prevented.

The anchoring portion 324 and the support portion 324a are preferably provided at positions that can reduce the occurrence of welded portions. As such a formation position, for example, there is a position that does not face the injection gate position of the molten resin that is the constituent material of the cylindrical body 301 . When the anchoring portion 324 and the support portion 324a are provided at a position facing the gate position, the injected molten resin collides directly with the anchoring portion 324 and the support portion 324a, separates, and then welds at the rejoined portion. Lines may occur, which is not preferable.

Furthermore, the shape of the anchoring portion 324 in a plan view (planar shape) and the cross-sectional shape of the support portion 324a (that is, the cross-sectional shape in a plane parallel to the surface of the base portion 322) reduce the occurrence of weld portions. It is preferable that the shape is obtained. For example, when the cylindrical body 301 is molded by inserting the bottom complementary part 321 into a pair of molds, the position of the injection gate of the molten resin, which is the constituent material of the cylindrical body 301, is shown in FIG. G ₁ and G ₂ are set so that the molten resin is injected toward the center of the bottom complementary portion 321 . Also, the planar shape of the anchoring portion and the cross-sectional shape of the support portion are symmetrical. Under such conditions, when the flowing molten resin collides with the supporting portion, a weld portion may be formed in the gap between the anchoring portion and the base portion, where the molten resin once diverges and then merges. In that case, the air in the mold stays as fine bubbles in the weld portion, and the bubbles can cause voids in the cylindrical body 301 after molding.

However, the anchoring portion 324 of the present embodiment is configured such that its planar shape as a whole is substantially arcuate. In addition, in the planar shape of the anchoring portion 324, the radial portion on the side facing the center of the bottom complementary portion 321 is curved concavely. Further, the support portion 324a is formed such that its cross-sectional shape matches the planar shape of the anchoring portion 324 except for the portion where the anchoring portion 324 forms a gap with the base portion 322. . When the anchoring portion 324 and the support portion 324a have such a shape, it is possible not to impede the molten resin injected from the gate position G1 and flowing in the direction indicated by the arrow A in FIG. 9(b) as much as possible. can. In addition, since the molten resin flowing in the direction indicated by the arrow A first enters the gap between the anchoring portion 324 and the base portion 322, it is possible to prevent the aforementioned weld portion from being generated. On the other hand, of the molten resin injected from the gate position G1, the molten resin that collides with the second puncture needle guide portion 325 and the reinforcing portion 327 changes its flow direction, and flows from the opposite side of the flow direction A to the anchoring portion. 324 and the support portion 324a (in the direction indicated by arrow B in FIG. 9B). However, since the molten resin has already entered the gap between the anchoring portion 324 and the base portion 322, it is possible to prevent the molten resin from colliding with each other in the gap to form a weld portion. . Thereby, voids can be prevented from being generated in the gap between the anchoring portion 324 and the base portion 322 .

The back surface 326 of the base portion 322 is joined by heat welding at the contact surface with the communication port 204 of the second container 20 . The thin portion 323 is provided so that the height position is inward compared to the rear surface 326 of the base portion 322 . Therefore, the thin portion 323 is separated from the communication port 204 of the second container 20 and the film portion 202 that seals the communication port 204, and is in a non-contact state.

The communicating portion 302 has a structure including a so-called double-ended needle, and specifically, as shown in FIGS. 2 It has at least a puncture needle 333 , a holding portion 334 and a guide portion 335 . 10(a) is a perspective view showing a schematic configuration of the communication portion 302, and FIG. 10(b) is a side view showing the communication portion 302. FIG.

The material of the communicating portion 302 is not particularly limited, and examples thereof include rigid polypropylene, rigid polyethylene, synthetic resin such as ABS resin, and metal such as stainless steel.

The overall shape of the plate-like portion 331 is circular, and its diameter is set so that it can slide while being in contact with the inner surface of the lower cylindrical body 313 of the cylindrical body 301 . The thickness of the plate-like portion 331 is not particularly limited, and can be set appropriately as required.

In addition, on the outer peripheral edge of the plate-like portion 331 , a climbing portion 337 is provided to facilitate getting over the second restricting portion 316 when the communicating portion 302 slides toward the bottom portion 320 . The riding portion 337 has a shape in which a thin plate is connected only at the base end portion in a rectangular notched portion corresponding to the shape of the second restricting portion 316 in the outer peripheral edge portion of the plate-like portion 331 . Also, the thickness of the riding portion 337 is thinner than that of the plate-like portion 331 . With such a structure of the riding portion 337 , when the riding portion 337 passes through the second restricting portion 316 , the riding portion 337 bends at the base end portion, and as a result, the riding portion 337 does not get over the second restricting portion 316 . making it possible. In addition, the riding portion 337 is provided corresponding to the second restricting portion 316 .

It should be noted that the present invention is not limited to the modes shown in FIGS. For example, a jumping portion 337' having a structure as shown in FIG. 11 may be used. FIG. 11 is a partially enlarged view showing a main part of the communication part 302 in the transfusion member 30. FIG. The riding portion 337′ includes a thin plate portion 337a connected to the mounting surface 343 at the outer peripheral edge portion of the plate-like portion 331 only at the base end portion, and a rib 337b provided vertically to the surface of the thin plate portion 337a. and The rib 337b has a right triangle shape and is located in the center of the thin plate portion 337a. The bottom side of the rib 337b is joined to the thin plate portion 337a, and the opposite side (that is, the side other than the bottom side and the oblique side) is joined to the mounting surface 343. As shown in FIG. By providing the rib 337a, it is possible to prevent the thin plate portion 337a from being maintained in a bent state at the base end portion after the second restricting portion 316 has overcome while allowing the second restricting portion 316 to climb over. .

The ribs 337b may be arranged in the center of the thin plate portion 337a, or may be arranged in pairs at both ends of the thin plate portion 337a. In this case, the mechanical strength of the thin plate portion 337a can be further improved.

Further, three projecting portions 338 are provided on the outer peripheral edge of the plate-like portion 331 . The protruding portion 338 protrudes from the outer peripheral portion of the plate-like portion 331 by its thickness. In addition, the projecting portion 338 has a plate-like shape having the same curvature as the circular plate-like portion 331, and extends in the same direction as the direction in which the second puncture needle 333 is erected with respect to the plate-like portion 331. It is set upright. As a result, the projecting portion 338 can be fitted to the slide guide portion 317, and the communicating portion 302 can be prevented from sliding toward the bottom portion 320 while rotating.

Incidentally, it is preferable that the projecting portion 338 is provided so as to correspond to the slide guide portion 317 . Moreover, the projecting portion 338 is not particularly limited to the shape of the present embodiment as long as it has a shape that can be fitted to the slide guide portion 317 described above. Furthermore, the thickness of the projecting portion 338 can be set according to the depth of the slide guide portion 317 . Further, regarding the length of the projecting portion 338 (maximum height from the plate-like portion 331 to the tip of the projecting portion 338 in the projecting portion 338 erected from the plate-like portion 331), the projecting portion 338 is the slide guide portion. 317 is not particularly limited as long as the fitting can be maintained.

The first puncture needle 332 pierces the elastic stopper 103 of the first container 10 and is erected at the center of one surface 339 of the plate-like portion 331 toward the opening of the tubular body 301 . ing. The length (height) of the first puncture needle 332 is not particularly limited as long as it can penetrate the elastic stopper 103 of the first container 10 . Also, the diameter of the first puncture needle 332 can be set as appropriate.

The second puncture needle 333 pierces the membrane portion 202 of the second container 20 and the thin portion 323 of the bottom portion 320 of the tubular body 301 , and has a tubular shape at the center portion of the other surface 340 of the plate-shaped portion 331 . It is erected toward the bottom 320 of the body 301 . The length (height) of the second puncture needle 333 is not particularly limited as long as it can penetrate the membrane 202 of the second container 20 and the thin portion 323 of the bottom 320 of the cylindrical body 301 . Also, the diameter of the second puncture needle 333 can be set as appropriate.

Also, as shown in FIGS. 12(a) and 12(b), the overall shape of the first puncture needle 332 is a columnar shape, and the distal end thereof has a pair of first cut portions 332a and 332b. It has a conical shape provided so as to be mutually back-to-back. As a result, the shape is such that the puncture resistance can be reduced. Similarly to the first puncture needle 332, the second puncture needle 333 also has a cylindrical overall shape, and the distal end thereof is arranged such that a pair of the second cut portions 333a and 333b are arranged to face each other. It has a conical shape. Further, inside the first puncture needle 332 and the second puncture needle 333, as shown in FIGS. 4 and 10(a), a communication path 336 is provided to enable communication. The communication path 336 is formed by the first cut portions 332a and 332b of the first puncture needle 332 and the second cut portions 333a and 333b of the second puncture needle 332 and the distal ends of the first puncture needle 332 and the second puncture needle 333, respectively. It is open at the part. As a result, the first puncture needle 332 penetrates the elastic stopper 103 of the first container 10, and the second puncture needle 333 penetrates the membrane portion 202 of the second container 20 and the thin portion 323 of the bottom portion 320 of the cylindrical body 301. allows mixing of the medicament contained in the first container with the liquid contained in the second container.

A first notch portion 332c and a second notch portion 333c are provided at the end portions of the first cut portion 332b and the second cut portion 333b (the end portion opposite to the tip of the first puncture needle 332), respectively. preferably. The shape of the opening (notch shape) of the first notch 332 c and the like is rectangular, and the long sides thereof match the extending directions of the first puncture needle 332 and the second puncture needle 333 . Here, when the drug in the first container 10 and the liquid in the second container 20 are mixed, gas enters the communication path 336, resulting in an air pool, and the surface tension of the liquid causes the liquid to flow into the communication path. 336, a so-called airlock phenomenon may occur. However, by providing the first notch portion 332c or the like in each of the first puncture needle 332 and the second puncture needle 333 as in the present embodiment, the gas that has entered the communication path 336 is It is possible to reduce the occurrence of air accumulation by escaping from such as. Also, even if an air pool occurs, it can be easily removed by applying a light impact.

In this embodiment, the first notch 332c is provided at the terminal end of the first cut portion 332b, and the second notch 333c is provided at the terminal end of the second cut portion 333b. Although described, the invention is not limited to this embodiment. For example, notches may be provided at the end portions of the first cut portion 332a and the second cut portion 333a. In addition, the first puncture needle 332 and the second puncture needle 333 are arranged such that a first notch portion 332c is provided at the terminal end of the first cut portion 332a and a second notch portion 333c is provided at the terminal end of the second cut portion 333b. may be provided so as to form a pair on different cut surface sides. Furthermore, the cutout shape of the first cutout portion 332c and the like is not particularly limited, and may be, for example, a wedge shape.

The holding portion 334 is erected on the plate-like portion 331 of the communication portion 302 toward the opening of the tubular body 301 . Three holding portions 334 are provided on the plate-like portion 331 , and are provided at positions equidistant from the first puncture needle 332 . Furthermore, the holding portions 334 are also provided so as to be equidistant from each other. As a result, the first container 10 can be held in the communicating portion 302 in a stable state. The number and positions of the holding portions 334 to be installed are not particularly limited, and can be appropriately set according to the shape, diameter, etc. of the mouth portion 102 of the first container 10 to be used.

A surface of the holding portion 334 facing the first puncture needle 332 is provided with a convex portion 334a for locking the neck portion 107 between the mouth portion 102 of the first container 10 and the first container body portion 101. ing. The convex portion 334a slopes gently toward the tip of the holding portion 334, and steeply slopes toward the opposite direction. As a result, when the first container 10 is inserted, the mouth portion 102 can relatively easily climb over the convex portion 334a, and the locking of the neck portion 107 by the convex portion 334a is facilitated. On the other hand, after the first container 10 is inserted into the communicating portion 302, the mouth portion 102 is made difficult to climb over the convex portion 334a, and the locking of the neck portion 107 by the convex portion 334a is not easily released. It has become.

The height of the holding portion 334 is not particularly limited, and can be set as appropriate. Further, the formation position of the convex portion 334a in the holding portion 334 is not particularly limited, and can be set as appropriate.

The guide portion 335 has a function of guiding the first puncture needle 332 so that it abuts against the central portion of the elastic plug 103 of the first container 10 when the first container 10 is inserted into the communicating portion 302 . The guide portion 335 is erected on the plate-like portion 331 of the communication portion 302 toward the opening of the tubular body 301 . Three guide portions 335 are provided on the plate-like portion 331 , and each guide portion 335 is provided so as to be positioned between the holding portions 334 described above. Further, each guide portion 335 is provided at a position equidistant from the first puncture needle 332, similarly to the case of the holding portion 334. As shown in FIG. Further, the holding portions 334 are also provided so as to be equidistant from each other. This eliminates the need to position the insertion position of the first container 10 when inserting the first container 10 into the communicating portion 302 , and allows the first container 10 to be easily inserted into the communicating portion 302 . be possible.

The guide portion 335 has a plate-like shape with a constant curvature, and tapers toward its tip. Further, the tip of the guide portion 335 is bent in a direction away from the first puncture needle 332 in order to facilitate insertion of the first container 10 . The height of the guide part 335 from the plate-like part 331 is not particularly limited, and can be set according to the size, shape, etc. of the first container 10 .

(Manufacturing method of transfer member)
Next, a method for manufacturing the transfusion member 30 of this embodiment will be described.
The manufacturing method of the transfusion member 30 of the present embodiment includes a bottom complementary portion forming step for forming the bottom complementary portion 321, a cylindrical body forming step for forming the cylindrical body 301, and a communicating portion for forming the communicating portion 302. It includes at least a molding step and an assembling step of assembling the transfusion member 30 by accommodating the communicating portion 302 inside the cylindrical body 301 .

The bottom complementary part molding step can be performed by injection molding using a pair of upper mold A and lower mold A, for example. That is, the upper mold A and the lower mold A are closed, and a molten resin (hereinafter referred to as “molten resin A”), which is a constituent material of the bottom complementary part 321, is placed in a cavity that enables molding of the bottom complementary part 321. .) is injected. The temperature of the molten resin A is not particularly limited, and is appropriately set according to the constituent material of the bottom complementary portion 321 and the like. The temperature of the molten resin A is usually set within the range of 180.degree. C. to 260.degree. Moreover, the injection pressure of the molten resin A is not particularly limited, and can be appropriately set according to need. The injected molten resin A is cooled for a predetermined time. After cooling, the mold is opened to form the bottom complementary portion 321 .

The cylindrical body molding step is a process of molding the cylindrical body 301 to which the bottom complementary portion 321 is joined by thermal welding at the contact surface with the bottom portion 320 by insert molding or two-color molding.

When performing insert molding, insert molding is performed after inserting the bottom complementary portion 321 into a pair of upper mold B and lower mold B for molding the cylindrical body 301 . The insert of the bottom complement 321 may be placed with either side of the bottom complement 321 facing upwards. When the upper mold B and the lower mold B are closed, a cavity for molding the tubular body 301 is formed in the mold. Molding of the cylindrical body 301 is performed by injecting a molten resin (hereinafter referred to as “molten resin B”), which is a constituent material of the cylindrical body 301, into the cavity.

Further, when two-color molding is performed, the lower mold A used in the bottom complementary part molding step is used as a common mold, and combined with the upper mold B for molding the cylindrical body 301, the cylindrical body 301 molding. That is, the cylindrical body 301 is molded by closing the lower mold A and the upper mold B and injecting the molten resin B into the cavities formed in these molds.

In both insert molding and two-color molding, the gate position of the molten resin B injected into the mold is as shown in FIG. It is set at the positions of G1 and G2 shown in _{( a} ). When the molten resin B is injected into the cavity from these gate positions, the surface of the base portion 322 of the bottom complementary portion 321 is melted by the heat of the molten resin B. As shown in FIG. When the first branched molten resin among the injected molten resin reaches the anchoring portion 324 , it flows so as to enter the gap between the anchoring portion 324 and the base portion 322 .

On the other hand, out of the molten resin B injected from the gate position G1, the molten resin B that collides with the _second puncture needle guide portion 325 and the reinforcing portion 327 moves in the left-right direction (parallel to the plane of symmetry P shown in FIG. 9A). direction). Further, the molten resin B injected from the gate position G2 also splits in the horizontal direction after colliding with the _second puncture needle guide portion 325 and the reinforcing portion 327 . Then, these branched molten resins B are rejoined, then branched again, and flow toward the anchoring portion 324 from the direction opposite to the first branched molten resin (for example, FIG. 9(b) direction indicated by arrow B). However, since the molten resin B has already flowed into the gap between the anchoring portion 324 and the base portion 322, it is possible to prevent the molten resin B from colliding with each other in the gap to form a weld portion. . As a result, it is possible to prevent voids from occurring in the gap between the anchoring portion 324 and the base portion 322 .

After that, the anchoring portion 324 and the support portion 324a are melted by the heat of the molten resin B because they cannot maintain their respective shapes. Subsequently, when the molten resin B in the cavity is cooled for a predetermined period of time, the tubular body 301 is molded in a state of being joined to the bottom complementary portion 321 by thermal welding.

The temperature of the molten resin B is not particularly limited as long as it causes thermal welding with the bottom complementary portion 321 and is integrally formed with the cylindrical body 301 . The temperature of the molten resin B is usually set within the range of 190°C to 290°C, for example. Moreover, the injection pressure of the molten resin B is not particularly limited, and can be appropriately set as necessary.

The communicating portion molding step can be performed by injection molding using a pair of upper mold C and lower mold C, for example. That is, the upper mold C and the lower mold C are closed, and a molten resin (hereinafter referred to as "molten resin C"), which is a constituent material of the communicating part 302, is placed in a cavity that enables molding of the communicating part 302. to inject. The injection pressure of the molten resin C is not particularly limited, and can be appropriately set as required. The injected molten resin C is cooled for a predetermined time. After cooling, the upper mold C and the lower mold C are opened, and the communication part 302 is taken out.

In the assembling process, the transfusion member 30 is assembled by accommodating the communicating portion 302 inside the cylindrical body 301 integrated with the bottom complementary portion 321 . Thus, the transfusion member 30 of the present embodiment can be produced.

In this embodiment, before the assembling process, a coating process may be performed to apply a lubricant to the inner surface of the thin portion 323 of the cylindrical body 301 formed in the cylindrical body forming process. . Although the application method is not particularly limited, for example, a cylindrical applicator pre-impregnated with a lubricant may be used, and the application may be performed by inserting the applicator into the second puncture needle guide portion 325. In addition, a method of applying the lubricant by dripping it into the second puncture needle guide portion 325 and a method of applying the lubricant by spraying the lubricant can also be used. Note that when a cylindrical applicator is used, the diameter of the applicator is preferably smaller than the inner diameter of the second puncture needle 325 . As a result, when the applicator is inserted into second puncture needle guide portion 325 , it is possible to prevent the applicator from contacting the inner side wall surface of second puncture needle guide portion 325 .

Further, a sealing process may be performed to seal the opening 314 by heat-sealing a film to the opening 314 of the upper tubular body 312 in the tubular body 301 after the assembly process. Here, the bottom portion 320 of the unused cylindrical body 301 is hermetically sealed because the bottom complementary portion 321 is joined by thermal welding. Therefore, by sealing the opening 314 of the upper cylindrical body 312 with a film by thermal welding, it is possible to prevent foreign matter from entering the interior of the cylindrical body 301 . Furthermore, after the film sealing process, a sterilization process may be performed to sterilize the inside of the cylindrical body 301 by irradiating the cylindrical body 301 with an electron beam.

(Other Matters)
In this embodiment, the case where the shape of the anchoring portion 324 is not maintained in joining with the cylindrical body 301 has been described as an example, but the present invention is not limited to this. The anchoring portion 324 may be joined to the tubular body 301 while maintaining its shape. Further, in this embodiment, the case where four anchoring portions 324 are provided has been described as an example, but the number of anchoring portions 324 is not particularly limited, and may be changed as appropriate. can be done. Furthermore, in the present embodiment, the case where each anchoring portion 324 is arranged on the same circumference on the base portion 322 has been described as an example, but the arrangement position is not limited to this aspect. do not have. For example, the anchoring portions 324 may be provided at arbitrary positions, such as arranging the anchoring portions 324 on different circumferences.

Moreover, in the present embodiment, the case where the second container 20 and the pouring member 30 are joined by heat welding at the contact surfaces has been described, but the present invention is not limited to this aspect. For example, as shown in FIG. 13, an annular locking portion 342 is provided on the bottom portion 320 of the transfusion member 30, and is locked to the flange portion 207 of the communication port 204 of the second container 20 so that the transfusion member 30 and the second container 30 are engaged. A mode in which two containers 20 are joined may be used.

In this case, the communication between the first container 20 and the second container 20 using the transfusion member 30 is achieved by locking the locking portion 342 of the transfusion member 30 to the flange portion 207 of the second container 20 . This is preferably done after joining 30 and second container 20 . The shape of the locking portion is not particularly limited to an annular shape as long as it can be locked to the flange portion 207 . For example, it may be an annular locking portion provided with at least one or more cutouts at an arbitrary position, or a plurality of projection-like locking portions provided at arbitrary positions and spaced apart from each other.

1 Drug Mixing Kit 10 First Container 20 Second Container 30 Transfusion Member 101 First Container Body 102 Mouth 103 Elastic Plug 104 Needle Piercing Surface 105 Recess 107 Neck 201 Second Container Body 202 Membrane 203 One End Part 204 Communication port 205 Other end 206 Extraction part 207 Flange part 301 Cylindrical body 302 Communication part 311 Stepped part 312 Upper cylindrical body 313 Lower cylindrical body 314 Opening 315 First restricting part 316 Second restricting part 317 Slide Guide portion 318 Third restricting portion 319 Hole portion 320 Bottom portion 321 Bottom complementary portion 322 Base portion 323 Thin portion 323a Back surface 324 Anchoring portion 324a Support portion 325 Puncture needle guide portion 326 Back surface 327 Reinforcing portion 328 Back surface 331 Plate-like portion 332 First puncture needle 333 Second puncture needle 334 Holding portion 334a Convex portion 335 Guide portion 336 Communicating passage 337 Riding portion 338 Overhanging portion 339 One surface 340 The other surface 341 Center lines A and B Flow direction P of molten resin Symmetry plane

Claims (16)

a cylindrical body;
A transfusion member that is housed inside the cylindrical body and has a communication part that is slidable along the inner surface of the cylindrical body,
The communication part is
a plate-like portion;
a first puncture needle erected toward the opening of the tubular body at the central portion of one surface of the plate-shaped portion;
a second puncture needle erected toward the bottom of the cylindrical body at the center of the other surface of the plate-shaped part,
The bottom of the cylindrical body is provided with a bottom complementary portion that closes the hole of the bottom from the outside,
The bottom complement is
a base;
a thin portion provided in the center of the base portion and capable of being penetrated by the second puncture needle;
and has a lower mechanical strength than the cylindrical body,
The bottom complementary portion is a transfusion member that is joined to the bottom of the cylindrical body in a state of being thermally welded at the contact surface with the bottom of the cylindrical body. 2. The transfusion member according to claim 1, wherein the contact surface of the base portion of the bottom complementary portion with the bottom portion of the cylindrical body is provided with an anchoring portion for reinforcing the joint with the bottom portion. . A plurality of the anchoring portions are provided in a region other than the region where the thin portion is provided on the base portion,
3. The transfusion member according to claim 2, wherein the transfusion members are arranged on the same circumference so as to be equidistant from each other. A part of the anchoring portion is supported by a support portion erected in a substantially vertical direction with respect to the base portion,
The portion not supported by the support portion extends in a direction parallel to the surface of the base portion and in a direction other than the center direction of the base portion while being separated from the base portion. 4. A transfusion member according to claim 2 or 3, wherein the transfusion member is present. The transfusion member according to any one of claims 2 to 4, wherein the bottom complementary portion and the bottom portion of the cylindrical body are joined by heat-melting at least the anchoring portion. A cylindrical puncture needle guide portion that guides penetration of the thin portion by the second puncture needle is provided in the center portion of the bottom complementary portion,
The thin portion is provided on the bottom surface of the puncture needle guide portion,
The transfusion member according to any one of claims 1 to 5, wherein the puncture needle guide portion protrudes inward of the cylindrical body from a hole in the bottom of the cylindrical body. A substantially truncated cone-shaped reinforcing portion tapering toward the inside of the cylindrical body is provided at the central portion of the base portion,
The puncture needle guide part is provided at the center of the reinforcing part so as to protrude toward the inside and the outside of the cylindrical body,
7. The transfusion member according to claim 6, wherein the outer surface of the thin portion provided on the bottom surface of the puncture needle guide portion is higher than the outer surface of the base portion. The transfer device according to any one of claims 1 to 7, wherein the inner surface of the thin portion is coated with a lubricant that reduces penetration resistance when the second puncture needle penetrates the thin portion. Note material. a cylindrical body;
A method for manufacturing a transfusion member that is housed inside the cylindrical body and has a communication part that is slidable along the inner surface of the cylindrical body,
a plate-shaped portion, a first puncture needle erected toward the opening of the tubular body at a central portion on one surface of the plate-shaped portion, and a central portion on the other surface of the plate-shaped portion, a communicating portion forming step of forming the communicating portion, which includes a second puncture needle erected toward the bottom portion of the tubular body;
forming a bottom complementary portion having a lower mechanical strength than that of the tubular body, the bottom complementary portion comprising a base portion and a thin portion provided in the center of the base portion and capable of being penetrated by the second puncture needle; a bottom complementary part forming step;
A cylindrical body molding step of molding the cylindrical body to which the bottom complement portion is joined by heat welding at the contact surface with the bottom portion by insert molding or two-color molding;
and an assembling step of assembling the transfusion member by accommodating the communicating portion in the cylindrical body integrated with the bottom complementary portion. The step of forming the complementary bottom portion is a step of forming the complementary bottom portion having an anchoring portion for reinforcing the joint with the bottom portion in a portion other than the thin portion provided in the center of the base portion. A method for manufacturing a transfusion member according to claim 9. A plurality of the anchoring portions of the bottom complementary portion formed in the bottom complementary portion forming step are provided in a region other than the region where the thin portion is provided on the base portion,
11. The method of manufacturing a transfusion member according to claim 10, wherein the members are arranged on the same circumference so as to be equidistant from each other. The anchoring portion of the bottom complementary portion molded in the bottom complementary portion molding step is
A part of the anchoring portion is supported by a support portion erected in a substantially vertical direction with respect to the base portion,
A portion not supported by the support portion extends in a direction parallel to the surface of the base portion and in a direction other than the center direction of the base portion while being separated from the base portion. 12. The method for manufacturing a transfusion member according to claim 10 or 11, wherein the transfusion member has a solid shape. The cylindrical body forming step is a step of thermally melting the anchoring portion of the bottom complementary portion by the heat of the molten resin to form the cylindrical body in which the bottom complementary portion is joined by thermal welding. A method for manufacturing a transfusion member according to any one of claims 10 to 12. A cylindrical puncture needle guide portion that guides penetration of the thin portion by the second puncture needle is provided in the center portion of the bottom complementary portion formed in the bottom complementary portion molding step,
Further, the thin portion is provided on the bottom surface of the puncture needle guide portion,
14. The method according to any one of claims 9 to 13, wherein the puncture needle guide portion protrudes inward of the cylindrical body from a hole in the bottom portion of the cylindrical body formed in the cylindrical body forming step. A method for manufacturing the described transfusion member. In the bottom complementary portion formed in the bottom complementary portion forming step, a substantially truncated conical reinforcing portion tapered toward the inside of the cylindrical body is provided at the center of the base portion. ,
The puncture needle guide part is provided at the center of the reinforcing part so as to protrude inwardly and outwardly of the cylindrical body formed in the cylindrical body forming step,
15. The method of manufacturing a transfusion member according to claim 14, wherein the outer surface of the thin portion provided on the bottom surface of the puncture needle guide portion is higher than the outer surface of the base portion. Before the assembling step, lubrication is applied to the inner surface of the thin portion of the cylindrical body formed in the cylindrical body forming step to reduce piercing resistance when the second puncture needle penetrates the thin portion. 16. The method for manufacturing a transfusion member according to any one of claims 9 to 15, wherein a coating step of coating the agent is performed.

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