JP6234225B2 - Connecting member with needle, drug dissolution kit - Google Patents

Description

The present invention relates to a connecting member with a needle configured so that another vial can be connected to a chemical solution container, and a drug dissolution kit in which the connecting member with a needle and the chemical solution container are connected.
This application claims priority based on Japanese Patent Application No. 2012-113517 for which it applied to Japan on May 17, 2012, and uses the content here.

  Conventionally, as a chemical solution dissolution kit, for example, techniques disclosed in Patent Documents 1 to 3 have been proposed.

  Patent Document 1 includes a chemical solution container and a vial holder. The chemical solution container has a communication port formed in the upper part of the container body and a chemical solution discharge port formed in the lower part. A coupling member is formed at the upper end of the communication port. The vial holder is provided with a vial mounting port and a medical needle projecting from the bottom inner surface of the holder body, and the bottom of the holder body and the chemical container are connected to each other. A drug dissolution kit characterized in that members are combined is disclosed.

  Patent Document 2 comprises a plastic solution container body made of plastic that can be freely deformed by pressing and having a mouth portion closed by a seal portion, and a pair of upper and lower needle bodies formed with a communicating hollow portion. A double-ended needle positioned above the mouth, a drug vial having a mouth positioned above the double-ended needle and sealed at the lower end, and the double-ended needle concentrically surrounding the lysate container mouth And a protective cap that extends upward so as to cover the drug vial and can be appropriately removed from the mouth, and the needle body of the double-ended needle has a mouth seal part of the drug vial in the protection cap Is pressed against the upper needle body, sliding with respect to the protective cap, puncturing the mouth seal portion of the dissolution liquid container with the lower needle body, and mouth seal of the drug vial with the upper needle body Puncture the part The double-headed needle-type dissolution is characterized in that the medicine in the container can be moved downward through the needle body each time the container is inserted and inserted into both containers and the containers after insertion are turned upside down. A liquid container is disclosed.

  Patent Document 3 discloses an infusion container having a flexible plastic container body in which a chemical solution such as a solution or a diluent is enclosed, and a means for communicating with another chemical solution container and a chemical solution outlet. The communication means is a combination of a puncture needle that communicates with the inside of the container body and that can be punctured into the mouth of another drug container, and is concentrically integrated with the puncture needle. The puncture needle is covered with a protective cap having a rubber inner layer made of a rubber member, and in this crowned state, the rubber inner layer of the protective cap is the puncture needle. A restraining mechanism is formed between the protective cap and the communication means to restrain the protective cap in a crowned state, and a sealing mechanism is formed around the needle to keep the puncture needle sterile and liquid-tight. The protective cap By the rotating operation, the infusion container, characterized in that it is configured to be taken selectively a restricting position and the non-arresting position is disclosed.

JP-A-10-33635 Japanese Utility Model Publication No. 6-22272 JP-A-8-24313

However, the above-described conventional technique has the following problems.
In the drug dissolution kit described in Patent Document 1, since the needle part, which is an assembly of a plurality of molded articles, is connected, it is difficult to guarantee the sterilization of the needle part in the sterilization process of the dissolution liquid part, and even a single needle is gamma sterilized. Therefore, there is a problem that the manufacturing cost becomes high.
The solution container with a double-ended needle described in Patent Document 2 has to be punctured by both double-ended needles in the stoppers of both the vial and the chemical solution, and the operation is troublesome. In addition, there are two opportunities for coring. Further, there is a problem that the cost is high due to the complicated structure.
The infusion container described in Patent Document 3 is a drug dissolution kit that exposes the needle before removing the needle cap and piercing the stopper of the vial. If the needle is exposed first, sterilization is guaranteed. There is a problem that it is not. Moreover, there is a problem such as danger because the needle tip is exposed.

  This invention is made | formed in view of the said situation, and makes it a subject to provide the connection member with a needle | hook which can perform a sterilization process simply when using as a chemical | medical agent dissolution kit, and a chemical | medical agent dissolution kit using the same.

  In order to achieve the above object, the present invention includes, for example, a member main body in which a hollow needle is erected and an elastic sheath covering the hollow needle, and is opposite to the side of the member main body in which the hollow needle is erected. A connecting member with a needle provided with a chemical container connecting portion configured to be connected to the chemical container on the surface side, wherein the elastic sheath body is in close contact with at least the outer surface of the hollow needle so as to be peeled off. Provided is a connecting member with a needle characterized by being covered in a state.

  In the connecting member with a needle of the present invention, it is preferable that the elastic sheath body is provided on the outer surface of the hollow needle by a two-color molding method.

  In the connecting member with a needle of the present invention, it is preferable that at least the outer surface of the hollow needle covered with the elastic sheath body is guaranteed to be sterilized.

  In the connecting member with a needle of the present invention, it is preferable that a flat portion is formed at the tip of the elastic sheath body.

  In the connecting member with a needle according to the present invention, the member body has a flange-shaped base portion having a flange portion that spreads from a peripheral edge of the base portion of the hollow needle, and the base portion of the elastic sheath body extends along the surface of the flange portion. It is preferable to have.

  In the connecting member with a needle of the present invention, it is preferable that the chemical solution container connecting portion has a connecting pipe portion connectable with a tubular connecting portion provided in the chemical solution container to be connected.

  In the connecting member with a needle of the present invention, it is preferable that a vial engaging portion to which a mouth portion of the vial is attached is provided on the surface side of the member main body where the hollow needle is erected.

  In the connecting member with a needle of the present invention, the chemical solution container connecting portion may have a connection screw portion that can be screwed to a tubular screw portion provided in the chemical solution container to be connected.

  Further, the present invention includes the connecting member with a needle and a chemical liquid container provided with a tubular connecting part, and the connecting pipe part provided in the connecting member with the needle and the tubular connecting part of the chemical liquid container can flow the chemical liquid. A drug dissolution kit characterized by being connected is provided.

  Further, the present invention includes the connecting member with a needle and a chemical liquid container provided with a tubular screw part, and the connecting screw part provided in the connecting member with a needle and the tubular screw part of the chemical liquid container can flow the chemical liquid. Provided is a drug dissolution kit characterized by being screwed.

  In the drug dissolution kit of the present invention, it is preferable that the chemical solution container is provided with a chemical solution outlet for allowing the contained chemical solution to flow out.

  In the drug dissolving kit of the present invention, it is preferable that a hanging tool configured to suspend and support the drug dissolving kit is provided on the connecting member with a needle or the chemical solution container.

  The present invention also includes the connection member with a needle and a chemical liquid container provided with a tubular screw portion, and is connected so that the connection screw portion provided in the connection member with a needle and the tubular screw portion of the chemical liquid container can be attached and detached. The drug dissolution kit is characterized in that both the connecting screw portion and the tubular screw portion are luer lock type.

The present invention has the following aspects.
(1) A member main body in which a hollow needle is erected, and an elastic sheath covering the hollow needle,
On the side opposite to the side where the hollow needle of the member body is erected, there is a connecting member with a needle provided with a chemical solution container connecting portion configured to be connected to a chemical solution container,
The elastic sheath body covers at least the outer surface of the hollow needle so as to be able to peel off, and a connecting member with a needle,
(2) The connecting member with a needle according to (1), wherein the elastic sheath body is provided on the outer surface of the hollow needle by a two-color molding method,
(3) The connecting member with a needle according to (1), wherein the elastic sheath body is provided on the outer surface of the hollow needle by an insert molding method,
(4) The connecting member with a needle according to any one of (1) to (3), wherein the outer surface of at least the hollow needle covered with the elastic sheath body is sterilized.
(5) The connecting member with a needle according to any one of (1) to (4), wherein a flat portion is formed at a tip of the elastic sheath body,
(6) The member main body has a flange portion that spreads from the periphery of the base portion of the hollow needle, and the base portion of the elastic sheath body has a flange-like base portion that extends along the surface of the flange portion. 1) A connecting member with a needle according to any one of (5),
(7) Any one of (1) to (6), wherein the chemical solution container connection portion includes a connection pipe portion configured to be connected to a tubular connection portion provided in the chemical solution container to be connected. A connecting member with a needle as described in
(8) On the surface side of the member main body where the hollow needle is erected, a vial engaging portion configured to be fitted with a mouth portion of the vial is provided, (1) to (7 ) A connecting member with a needle according to any one of
(9) Any one of (1) to (8), wherein the chemical solution container connection portion includes a connection screw portion configured to be screwed to a tubular screw portion provided in the chemical solution container to be connected. The connecting member with a needle according to item,
(10) A connecting member with a needle according to any one of (1) to (8) and a chemical solution container provided with a tubular connecting part, and a connecting pipe part provided on the connecting member with a needle, A drug dissolution kit, connected to the tubular connection part of the drug solution container so that the drug solution can circulate;
(11) The connecting member with a needle according to (9) and a chemical liquid container provided with a tubular screw part, wherein the connecting screw part provided in the connecting member with a needle and the tubular screw part of the chemical liquid container are chemicals Drug dissolution kit, connected by screwing, so that can be distributed
(12) The drug solution kit according to (10) or (11), wherein the drug solution container is provided with a drug solution outlet for allowing the contained drug solution to flow out.
(13) The drug dissolution kit according to (10) or (12), wherein the connecting member with a needle or the drug solution container is provided with a hanging tool configured to suspend and support the drug dissolution kit, and 14) The connecting member with a needle according to (9) and a chemical liquid container provided with a tubular screw part, the connecting screw part provided in the connecting member with a needle and the tubular screw part of the chemical liquid container; Are connected so as to be detachable, and both the connecting screw portion and the tubular screw portion are luer lock type.

  The connecting member with a needle according to the present invention includes a member main body in which a hollow needle is erected and an elastic sheath body that covers the hollow needle, and the surface of the member main body opposite to the side in which the hollow needle is erected. Is provided with a chemical solution container connecting portion configured to be connected to the chemical solution container, and the elastic sheath body is configured to cover at least the outer surface of the hollow needle so as to be peeled off, When forming an elastic sheath covering the hollow needle, the outer surface of the hollow needle covered by at least the elastic sheath can be sterilized by molding the elastic sheath by bringing the molten resin into close contact with the outer surface of the hollow needle, Since this part can be assured of sterilization, the sterilization process can be easily performed when used as a drug dissolution kit.

  Since the drug dissolution kit of the present invention is configured to connect the drug solution container connecting portion of the connecting member with a needle to the drug container, at least the outer surface of the hollow needle covered with the elastic sheath body can guarantee sterilization. When used as a drug dissolution kit, a sterilization step can be easily performed.

It is front sectional drawing which shows the 1st example of the connection member with a needle | hook of this invention. It is a schematic diagram of a hollow needle. It is front sectional drawing which shows the state which attaches a vial bottle to a connection member with a needle | hook. It is front sectional drawing which shows the 2nd example of the connection member with a needle | hook of this invention. It is front sectional drawing which shows the 1st example of the chemical | medical agent dissolution kit of this invention. It is front sectional drawing which shows the manufacturing process of a chemical | medical agent dissolution kit. It is front sectional drawing which shows the use condition of a chemical | medical agent dissolution kit. It is front sectional drawing of the chemical | medical agent dissolution kit which has a hanging tool. It is front sectional drawing which shows the 1st example of the attachment method of a hanging tool. It is front sectional drawing which shows the 2nd example of the attachment method of a hanging tool. It is front sectional drawing which shows the manufacturing process of the 2nd example of the chemical | medical agent dissolution kit of this invention. It is front sectional drawing which shows the use condition of the 2nd example of the chemical | medical agent dissolution kit of this invention.

Hereinafter, embodiments of the present invention will be described with reference to the drawings.
The configurations of the connecting member with a needle and the drug dissolution kit described below are merely examples of the present invention, and the present invention is not limited to these examples, and various changes and modifications can be made.

(Connecting member with needle)
FIG. 1 is a view showing a first example of a connecting member with a needle of the present invention.
The connecting member with a needle 1 of this example includes a member main body 3 in which a hollow needle 2 is erected and an elastic sheath body 4 that covers the hollow needle 2, and the hollow needle 2 of the member main body 3 is erected. On one surface side, a vial engaging portion 8 configured to be fitted with the mouth portion 7 of the vial 6 is provided, and on the other surface side of the member main body 3, a drug solution container can be connected. The connecting tube portion 12 (chemical solution container connecting portion) configured as described above is provided, and the elastic sheath body 4 covers at least the outer surface of the hollow needle 2 in a close contact state so as to be peeled off. .

In this example, the member main body 3 has a flange portion 11 that spreads from the periphery of the base portion of the hollow needle 2, and a base portion of the elastic sheath body 4 has a flange-like base portion 13 that extends along the surface of the flange portion 11. ing. By providing the flange-like base portion 13 that extends along the surface of the flange portion 11 in this way, when the vial 6 is attached, the top surface of the mouth portion 7 made of an aluminum cap or the like and the flange-like base portion made of an elastic resin. 13, the flange-like base portion 13 acts as a packing, and liquid leakage from this portion can be prevented.
The base portion of the hollow needle 2 indicates a root portion of the hollow needle 2 having the through hole 5 at the tip portion, and is a portion located at the center portion of the flange portion 11.
The base portion of the elastic sheath body 4 indicates an elastic sheath body portion at the upper part of the base portion of the hollow needle 2 and is a portion located at the center of the elastic sheath body 4 of the flange portion 11.

On one surface side of the member body 3 where the hollow needle 2 is erected, a vial engaging portion 8 including two or more protruding pieces 9 protruding upward from the peripheral edge of the flange portion 11 is provided. It has been.
As shown in FIG. 3, these protrusions 9 are formed with locking claws 10 that engage with the mouth portion 7 of the vial 6 when the vial 6 is attached to the connecting member 1 with a needle.

  The member body 3 and the hollow needle 2 are integrally molded products of synthetic resin. As this synthetic resin, since it is important to maintain the shape even when inserted into the stopper of the vial 6, polyethylene, polypropylene, polycarbonate, ABS resin, and AS resin are used as resins having high rigidity suitable for the Japanese Pharmacopoeia. Etc. are preferably used, and polypropylene is more preferred.

The hollow needle 2 only needs to be configured so as to be able to puncture the stopper provided in the mouth portion 7 of the vial 6, and the dimensions and the tip shape are not particularly limited.
As an example, there is a hollow cylindrical hollow needle 2 having a pointed tip as shown in FIG.
When the hollow needle 2 having the shape shown in FIG. 2 is used, the diameter φa of the hollow needle 2 is preferably about 2.5 to 3.5 mm, and the cylindrical part length b is preferably about 7.0 to 8.0 mm. The height c is preferably about 15 to 17 mm.

  The through-hole 5 drilled in the hollow needle 2 is configured such that one end is opened at the distal end of the hollow needle 2 and the other end is opened on the other surface side of the member main body 3 so that the drug solution can flow. It has a hole diameter.

The material of the elastic sheath body 4 is a resin conforming to the Japanese Pharmacopoeia, and an injectable thermoplastic elastomer can be used. Styrene-ethylene-butylene-styrene block copolymer (SEBS), styrene-ethylene- Block copolymer consisting of propylene-styrene block copolymer (SEPS), hydrogenated styrene-butadiene rubber (HSBR), styrene-ethylene-butadiene rubber (SEBR), or crystalline polyolefin block-ethylene block-butylene block-crystalline polyolefin block Examples thereof include a combination (CEBC), an ethylene / vinyl alcohol copolymer (EVOH), and polyethylene.
When the material of the member body 3 and the hollow needle 2 is polypropylene, it is preferable to use styrene-ethylene-butylene-styrene block copolymer (SEBS) or a mixed material thereof as the material of the elastic sheath body 4. Alternatively, in order for the hollow needle 2 and the elastic sheath 4 to have an appropriate peelability, styrene-ethylene-butylene-styrene block copolymer (SEBS), ethylene / vinyl alcohol copolymer (EVOH), polyethylene (PE ) Is preferably mixed.

The elastic sheath body 4 covers the outer surface of the hollow needle 2 and is formed along the upper surface of the flange portion 11 of the member main body 3. The tip of the elastic sheath body 4 is a flat portion 14 formed in a flat shape without matching the shape of the tip of the hollow needle 2. The thickness of the elastic sheath body 4 covering the needle tip of the hollow needle 2 is such that the needle tip does not protrude carelessly and does not become a resistance when puncturing the stopper of the vial 6. Is preferably from 1 mm to 10 mm, more preferably from 1 mm to 5 mm.
The tip of the elastic sheath body 4 uses a resistance generated when the vial 6 is mounted, and the elastic sheath body 4 is peeled off, so that the portion having the flat portion 14 that does not enter the vial 6 and receives the mounting resistance is used. Show.
By providing the flat portion 14 at the distal end of the elastic sheath body 4, the elastic sheath body 4 is peeled off from the distal end portion of the hollow needle 2 when the vial 6 is attached to the vial engaging portion 8. However, the operation of breaking through the flat surface portion 14 of the elastic sheath 4 and piercing the stopper of the vial 6 and entering the inside of the vial 6 is performed smoothly. If the flat surface portion 14 is not provided or the outer diameter of the flat surface portion 14 is small, the elastic sheath body 4 may enter the inside of the vial 6 without being peeled off from the hollow needle 2. In order to prevent this, it is preferable that the outer diameter of the flat portion 14 is not less than the diameter a of the hollow needle 2.

The connecting member 1 with a needle of this example is preferably manufactured by a two-color molding method using the resin material of the member main body 3 including the hollow needle 2 and the resin material of the elastic sheath body 4.
The two-color molding method is a molding technique in which different materials (materials) are combined and molded integrally. The two-color molding method in the manufacturing method of the connecting member 1 with a needle of this example is to mold the member main body 3 including the hollow needle 2 and within the same mold as the hollow needle 2 after the molding of the member main body 3. This includes forming the elastic sheath body 4 integrally with the member main body 3. The method of manufacturing the elastic sheath body 4 includes putting the hollow needle 2 into the cavity that becomes the elastic sheath body 4 while rotating the mold while the molded member main body 3 remains in the same core as the hollow needle 2, and This includes pouring the material to be the elastic sheath body 4 from the gate opening of the cavity of the elastic sheath body 4. By such a two-color molding method, the connecting member with a needle 1 of this example is a product in which the member main body 3 including the hollow needle 2 and the elastic sheath body 4 are integrated. The molding order is not limited to this, and the elastic sheath body 4 side can be molded first.

As a manufacturing method of the connection member 1 with a needle | hook of this application, it can also manufacture by an insert molding method other than the method shown above.
In the case of the insert molding method, the member main body 3 is first formed, the member main body 3 is attached to the cavity of the elastic sheath body 4, and different materials (or different materials) are integrally formed.
In the insert molding method, only the member main body 3 can be molded first and left.
In the insert molding method, silicone oil can be applied to the surface of the hollow needle 2 before being integrated with the elastic sheath body 4 in order to further enhance the peeling effect of the elastic sheath body 4. It is possible to easily apply silicone oil before integrating the elastic sheath body 4 and the member main body 3 in the insert molding method (since only the member main body 3 is reserved in advance in the insert molding method).
In the insert molding method, the silicone oil is preferably applied to the surface portion including the tip of the hollow needle 2 excluding the flange portion 11, and the elastic sheath body 4 is not applied to the flange portion 11 by applying silicone oil. Can be prevented from peeling off.
In the manufacture of the connecting member with a needle 1 by the two-color molding method or the insert molding method, it is preferable that the molding condition of the member main body 3 including the hollow needle 2 is within a range of a resin temperature of 180 to 300 ° C. Moreover, it is preferable that the molding conditions of the elastic sheath body 4 be within a range of a resin temperature of 150 to 250 ° C.

The result of the molding test of the connecting member with needle by insert molding is shown below.
First, hollow needles (PP) were injection molded, and then an elastic sheath body was molded with the resin of the blending examples shown in Table 1 below. As a result, a peeled state as shown in Table 1 was obtained.

The stretchability and peelability of the connecting member with needle were subjected to sensory evaluation by actually attaching the connecting member 3 with needle and the vial 6.
When the elastic sheath body 4 and the hollow needle 2 are peeled off, it is necessary to insert only the hollow needle 2 into the vial 6 while the elastic sheath body 4 and the hollow needle 2 are peeled off. Without being inserted into the inside of the vial 6, the connecting member 3 with the needle and the vial 6 are compressed into the gap at the time of mounting. In this case, the stretchability of the connecting member 3 with a needle means whether the elastic sheath body 4 can be easily compressed into the gap when the connecting member 3 with the needle and the vial 6 are mounted.
The stretchability of the connecting member 3 with a needle was evaluated according to the following criteria.
A: It can be easily compressed.
B: Although compressible, the pressing energy at the time of wearing is required compared with A.
C: The elastic sheath body 4 is hard and compression is difficult.

The peelability of the connecting member 3 with a needle was evaluated according to the following criteria.
A: The hollow needle 2 and the elastic sheath body 4 easily peel off.
B: Separation of the hollow needle 2 and the elastic sheath body 4 is relatively easy, but the energy at the time of wearing is required as compared with A.
C: The hollow needle 2 and the elastic sheath body 4 are peeled off, but more energy is required for mounting than B.
D: Unpeelable.

When the connecting member 1 with a needle is manufactured by the two-color molding method or the insert molding method, a molten needle is supplied to the outer surface of the hollow needle 2 of the member main body 3 to mold the elastic sheath body 4, thereby forming a hollow needle. When the outer surface of 2 comes into contact with the molten resin, the temperature becomes high, and at least the outer surface of the hollow needle 2 is in a sterilized state.
Therefore, the obtained connecting member 1 with a needle can ensure that at least the outer surface of the hollow needle 2 is sterilized if the elastic sheath 4 is intact.
Sterilization is what is called reducing the probability that microorganisms will survive in an object to be sterilized to 1 / 1,000,000 or less (that is, 1 object or less to be sterilized out of 1 million objects to be sterilized). is there. In the present application, since the elastic sheath body 4 is formed by bringing a molten high-temperature elastic resin into contact with the outer surface portion of the molded hollow needle 2, at least the outer surface of the hollow needle 2 is sterilized to achieve a so-called aseptic condition. can do. That is, at least the outer surface of the hollow needle 2 can be assured.
A through hole 5 is set at the tip of the hollow needle 2, and the chemical solution and the outer surface of the hollow needle 2 come into contact through the through hole 5. Since the hollow needle 2 and the elastic sheath body 4 are not completely welded except for the flange portion 11, wet heat generated during sterilization of the chemical solution through the through-hole 5 to the unsealed elastic sheath body portion. Can also enter. Sterilization of the present application is to reduce the probability of survival of an object to be sterilized, that is, at least microorganisms adhering to the outer surface of the hollow needle 2 by placing the connecting member with a needle 1 in the above-described situation.

FIG. 3 is a view showing a state when the vial 6 containing a medicine is attached to the connecting member 1 with a needle. As the vial bottle 6, a vial bottle having a stopper that can be punctured on the top surface of the mouth 7, which is normally used in the medical field, can be used.
When the vial 6 is attached, the stopper on the top surface of the mouth portion 7 of the vial 6 is exposed, and the mouth portion 7 is pushed into the vial engaging portion 8 of the connecting member 1 with a needle. Easy to install.

  When the vial body is attached, when the stopper of the vial 6 is brought into contact with the needle tip of the hollow needle 2 via the elastic sheath body 4 and a pressing force is applied thereto, the stopper body is connected to the hollow needle 2 via the elastic sheath body 4. Hit the tip of the needle. Further, due to the pressing force applied to the needle tip of the hollow needle 2, the elastic sheath body 4 is peeled from the outer surface of the distal end portion of the hollow needle 2, the needle tip of the hollow needle 2 breaks through the elastic sheath body 4, and further punctures the plug body. Inserted into the vial 6.

  The mouth part 7 of the vial 6 advances to the flange part 11 side while spreading two or more projecting pieces 9 outward, and each engaging claw 10 gets over the mouth part 7 and reaches the reduced diameter part of the mouth. Thereafter, each protrusion 9 is elastically restored, and each engaging claw 10 is engaged with the mouth to hold the vial 6.

  In a state where the vial 6 is held by the engaging claw 10, the hollow needle 2 penetrates the stopper and reaches the inside of the vial 6, and is connected to the inside of the vial 6 through the through hole 5 of the hollow needle 2. The pipe portion 12 is in communication with the inside of the pipe.

  The connecting member 1 with a needle of this example includes a member main body 3 in which a hollow needle 2 is erected and an elastic sheath body 4 that covers the hollow needle 2, and one of the member main body 3 in which the hollow needle 2 is erected. On the surface side, a vial engaging portion 8 configured to be fitted with the mouth portion 7 of the vial 6 is provided, and the other surface side of the member main body 3 is configured to be connected to a drug solution container. Since the connecting tube portion 12 (medical solution container connecting portion) is provided and the elastic sheath body 4 is configured to cover at least the outer surface of the hollow needle 2 so as to be peeled off, the hollow needle 2 is provided. When forming the elastic sheath body 4 to be covered, the outer surface of the hollow needle 2 covered with at least the elastic sheath body 4 can be sterilized by molding the elastic sheath body 4 by bringing the molten resin into close contact with the outer surface of the hollow needle. Because this part can guarantee sterilization, when using it as a drug dissolution kit It is possible to perform the bacterial processes easily.

FIG. 4 is a view showing a second example of the connecting member with a needle of the present invention.
The connecting member 17 with a needle of this example is configured to include substantially the same components as the connecting member 1 with a needle of the first example described above, and the same components are denoted by the same reference numerals.
The connecting member 17 with a needle of this example is provided with a connecting screw part 15 in which a screw part 16 (male thread) is formed on the outer peripheral surface of the tubular body, instead of the connecting pipe part 12, as a chemical container connecting part. It is characterized by.

When the prefilled syringe type chemical solution container provided with the tubular screw portion is used, the connection screw portion 15 is formed by screwing the connection screw portion 15 onto the tubular screw portion of the chemical solution container, thereby connecting the connection member 17 with the needle and the chemical solution. Connect the container so that it can be removed.
The screwing of the connection screw portion 15 to the tubular screw portion of the chemical liquid container means that the connection screw portion 15 is screwed into the tubular screw portion of the chemical liquid container.
In the example illustrated in FIG. 4, the screw portion 16 that is a male screw is formed on the outer peripheral surface of the connection screw portion 15, but it is adapted to a chemical solution container in which a male screw is formed on the tubular screw portion. In this case, the connecting screw portion 15 may be provided with a connecting screw portion in which a female screw is formed on the inner peripheral surface of the tubular body.

  The connecting member 17 with the needle of this example can obtain substantially the same effect as the connecting member 1 with the needle of the first example described above, and can further be connected to the tubular screw portion of the chemical container so as to be detachable. With this configuration, it is possible to expand the usage forms of the drug dissolution kit, such as enabling replacement and replacement of the chemical solution container.

(Drug dissolution kit)
FIG. 5 is a diagram showing a first example of the drug dissolution kit of the present invention.
The drug dissolution kit 20 of the present example includes the above-described connecting member 1 with a needle and a chemical solution container 22, and the connecting pipe portion 12 provided on the connecting member 1 with a needle and the tubular connecting portion 21 of the chemical solution container 20 are connected to each other. It has been configured.

  The chemical solution container 22 is formed by sealing and filling a chemical resin container body 23 with a chemical solution 23. The tubular connection portion 21 is provided at one end of the container body, and a needle is attached to the distal end of the tubular connection portion 21. The connecting member 1 is welded and joined. The other end of the container main body is provided with a chemical liquid outlet 25 for allowing the stored chemical liquid 23 to flow out, and a stopper 26 is provided at the opening of the chemical liquid outlet 25.

  The connecting pipe portion 12 of the connecting member 1 with the needle and the tubular connecting portion 21 of the chemical solution container 20 are welded and joined at the joining portion 24. When the connecting pipe portion 12 of the connecting member 1 with the needle and the tubular connecting portion 21 of the chemical solution container 20 are made of the same kind of synthetic resin, for example, polypropylene, the end portions of the connecting pipe portion 12 and the tubular connecting portion 21 are used. They can be melted together and welded easily. The method for connecting the connecting pipe portion 12 and the tubular connecting portion 21 is not limited to welding joining, and may be a connecting method using an appropriate connecting member such as a joint member.

FIG. 6 is a diagram showing a manufacturing process of the drug dissolution kit 20 of this example.
In order to manufacture this medicine dissolution kit 20, the connecting member 1 with a needle and the chemical solution container 22 are separately formed and prepared (FIG. 6 (a)). The chemical solution container 22 is empty without the chemical solution 23, and the chemical solution outlet 25 is open.
Next, as shown in FIG.6 (b), each edge part of the tubular connection part 21 of the chemical | medical solution container 22 and the connection pipe part 12 of the connection member 1 with a needle | hook is heated, and it welds and joins by abutting.

Next, the chemical liquid 23 is injected into the container from the chemical liquid outlet 25 of the chemical liquid container 22, and then a sealing body 26 is attached to the opening of the chemical liquid outlet 25 as shown in FIG. 22 is sealed. Thereby, the medicine dissolution kit 20 is produced. The manufacturing process of the medicine dissolution kit 20 is not limited to the manufacturing process shown in FIG. 6. The sealing member 26 is attached to the chemical liquid container 22, the chemical liquid is filled from the tubular connection part 21, and the connecting member 1 with a needle is attached. A process of connecting may be used.
Next, the drug dissolution kit 20 is sterilized (FIG. 6D). The chemical solution stored in the chemical solution container 22 is sterilized by a sterilization process such as high-pressure steam sterilization. At this time, since the inside of the chemical solution container 22 and the through-hole 5 of the hollow needle 2 communicate with each other, the inside of the hollow needle 2 is sterilized simultaneously with the sterilization of the chemical solution 23.

FIG. 7 is a diagram showing a method of using the drug dissolution kit 20 in a medical facility or the like.
The drug dissolution kit 20 is configured to push the mouth part 7 of the vial 6 in which the desired drug 18 is sealed into the hollow needle 2 side of the connecting member 1 with a needle shown in FIG. And the inside of the chemical liquid container 22 communicate with each other, so that the medicine 18 and the chemical liquid 23 can be mixed.
As shown in FIG. 7B, when the mouth portion 7 of the vial 6 is pushed in, the stopper of the vial 6 comes into contact with the tip of the hollow needle 2 via the elastic sheath body 4 so that the pressing force is applied. When applied, the stopper hits the tip of the hollow needle 2 through the elastic sheath 4. Further, due to the pressing force applied to the needle tip of the hollow needle 2, the elastic sheath body 4 is peeled from the outer surface of the distal end portion of the hollow needle 2, the needle tip of the hollow needle 2 breaks through the elastic sheath body 4, and further pierces the plug body. Then, the hollow needle 2 is inserted into the vial 6.

At the same time as the hollow needle 2 enters the inside of the vial 6, the through hole 5 is exposed inside the vial 6, and the inside of the vial 6 and the inside of the drug solution container 22 communicate with each other through the through hole 5 of the hollow needle 2. In this state, the drug solution kit 20 is directed upward to inject the drug solution 23 into the vial 6. The drug 18 contained in the vial 6 is dissolved (or dispersed) by the drug solution injected into the vial 6, and then the drug dissolution kit 20 is directed downward to remove the drug in the vial 6. The contained chemical liquid moves into the chemical liquid container 22 through the through hole 5.
The drug solution 23 containing the drug 18 is supplied to the patient's body or the like through a liquid guide line or the like that is pierced through the stopper 26 of the drug solution container 22.

  Since the drug dissolution kit 20 has a configuration in which the connecting member 1 with the needle is connected to the drug container 22, at least the outer surface of the hollow needle 2 covered by the elastic sheath body 4 can be guaranteed sterilization. When using as 20, a sterilization process can be performed simply.

FIG. 8 is a view showing an example provided with a lifting tool 27 configured to suspend and support the drug dissolution kit 20 described above.
In this example, a synthetic resin band-shaped lifting tool 27 is used, and both ends of the lifting tool 27 are attached to the outer surface of the member body 3 of the connecting member 1 with a needle. The joining position of the hanger 27 is not limited to this example, and the hanger 27 may be joined to the chemical solution container 22 side, or hanger having various shapes other than the band shape may be used.

FIG. 9 is a diagram illustrating a first example of a method for attaching the hanger 27.
In this example, the end of the hanger 27 is superposed on the outer surface of the member main body 3 of the connecting member 1 with the needle, the heater 28 is brought close to the heated portion, and the end of the hanger 27 is placed on the outer surface of the member main body 3. Welding.

FIG. 10 is a diagram illustrating a second example of a method for attaching the hanger 27.
In this example, attachment holes 27a are formed at both ends of the hanger 27, and mushroom-like protrusions 29 having heads configured to be inserted into the holes 27a are formed on the outer surface of the member body 3. Keep it. Then, by inserting the protrusions 29 on the outer surface of the member main body 3 into the holes 27a of the hanger 27, both ends of the hanger 27 can be attached to the outer surface of the member main body 3 of the connecting member 1 with the needle.

FIG. 11 is a front sectional view showing a manufacturing process of the second example of the drug dissolution kit of the present invention.
In the drug dissolution kit 35 of this example, as shown in FIG. 11 (e), the connecting member 17 with the needle shown in FIG. 4 provided with the connecting screw portion 15 and the drug solution 32 are sealed with a rubber sealing material 33. The syringe 30 (chemical solution container) and the piston member 34 having the distal end inserted into the syringe 30 are configured. The distal end portion of the syringe 30 is provided with a tubular screw portion 31 provided with a screw portion 31a (female screw) on the inner peripheral surface, and the connection screw portion 15 of the connecting member 17 with the needle is provided on the tubular screw portion 31. Inserted and screwed, the connecting member 17 with the needle and the syringe 30 are connected. An o-ring for preventing liquid leakage may be interposed at the connection portion between the tubular screw portion 31 and the connection screw portion 15.
The connection screw portion 15 being screwed to the tubular screw portion 31 means that the connection screw portion 15 is screwed into the tubular screw portion 31 and attached.

In order to manufacture the drug dissolution kit 35, a separately prepared syringe 30 and a connecting member 17 with a needle are prepared, and a connecting member with a needle is attached to the tubular screw portion 31 of the syringe 30 as shown in FIG. 17 connecting screw portions 15 are fitted and screwed by turning in a mounting direction indicated by an arrow in the figure.
As shown in FIG. 11 (b), after the screwing of the connecting screw portion 15 of the connecting member 17 with the needle and the tubular screw portion 31 of the syringe 30 is completed and the connecting member 17 with the needle and the syringe 30 are connected, As shown in FIG. 11 (c), a chemical solution 32 is injected into the syringe 30.
Next, as shown in FIG. 11 (d), a rubber sealing material 33 is plugged into the syringe 30 to seal the chemical solution 32 in the syringe 30, and the entire kit is further heat sterilized.
Next, as shown in FIG. 11 (e), a piston member 34 for moving the rubber sealing material 33 is attached from the rear end side of the syringe 30 to obtain a drug dissolution kit 35.

FIG. 12 is a diagram illustrating a method of using the drug dissolution kit 35 of this example.
In order to mix another drug in the vial 6 with the drug solution 32 of the drug dissolution kit 35, the mouth portion 7 of the vial 6 is connected with a needle of the drug dissolution kit 35 as shown in FIG. The member 17 is pushed into the vial engaging portion 8. By this pushing operation, the hollow needle 2 breaks through the elastic sheath body 4 and the stopper provided on the top surface of the vial 6 and enters the vial 6. Thereafter, the piston member 34 of the syringe 30 is pushed in to inject a part or all of the drug solution 32 into the vial 6 and shaken to dissolve the drug in the vial 6. Next, the piston member 34 of the syringe 30 is pulled, and the drug solution 32 containing the drug in the vial 30 is sucked into the syringe 30.

Next, as shown in FIG.12 (b), the vial 6 is removed from the vial engaging part 8 of the connection member 17 with a needle | hook.
Next, the connecting member 17 with the needle is rotated in the direction of detachment from the syringe 30 and the connecting member 17 with the needle is removed from the syringe 30 (FIG. 12C).
Next, as shown in FIG. 12 (d), the luer lock type line 36 is connected to the tubular threaded portion 31 of the syringe 30, and a chemical solution containing the drug in the syringe 30 is mixedly injected.
The luer lock type refers to a method of attaching in a screwed and fixed manner formed into a screwed shape in accordance with the tubular screw portion 31.

Since this medicine dissolution kit 35 has a configuration in which the connecting member 17 with a needle is connected to the syringe 30, at least the outer surface of the hollow needle 2 covered with the elastic sheath body 4 can be assured of sterilization. Can be done.
In addition, since the drug dissolution kit 35 is configured to connect the syringe 30 that is a chemical solution container and the connecting member 17 with the needle so as to be detachable, the connecting member 17 with the needle is removed from the syringe 30 after the drug is dissolved in the chemical solution. The use form of the drug dissolution kit can be expanded.

The connecting member with a needle according to still another aspect of the present invention is:
A member main body in which a hollow needle is erected, and an elastic sheath covering the hollow needle,
On the side opposite to the side where the hollow needle of the member body is erected, there is a connecting member with a needle provided with a chemical solution container connecting portion configured to be connected to a chemical solution container,
The elastic sheath body covers at least the outer surface of the hollow needle so that it can be peeled off,
The elastic sheath body is provided on the outer surface of the hollow needle by a two-color molding method or an insert molding method,
At least the outer surface of the hollow needle covered by the elastic sheath body is guaranteed to be sterilized,
A flat portion is formed at the tip of the elastic sheath body,
The member main body has a flange portion that spreads from the base periphery of the hollow needle, and the base portion of the elastic sheath body has a flange-like base portion that extends along the surface of the flange portion,
The chemical liquid container connecting portion has a connecting pipe portion configured to be connected to a tubular connecting portion provided in a chemical liquid container to be connected,
On the surface side where the hollow needle of the member body is erected, a vial engaging portion configured to be attached to the mouth portion of the vial is provided,
The chemical liquid container connecting portion has a connection screw portion configured to be screwed into a tubular screw portion provided in the chemical liquid container to be connected,
The member body and the hollow needle are made of polypropylene,
The elastic sheath body is preferably made of styrene-ethylene-butylene-styrene block copolymer (SEBS).

The drug dissolution kit according to another aspect of the present invention is as follows.
A member main body in which a hollow needle is erected, and an elastic sheath covering the hollow needle,
On the side opposite to the side where the hollow needle of the member body is erected, there is a connecting member with a needle provided with a chemical solution container connecting portion configured to be connected to a chemical solution container,
The elastic sheath body covers at least the outer surface of the hollow needle so that it can be peeled off,
The elastic sheath body is provided on the outer surface of the hollow needle by a two-color molding method or an insert molding method,
At least the outer surface of the hollow needle covered by the elastic sheath body is guaranteed to be sterilized,
A flat portion is formed at the tip of the elastic sheath body,
The member main body has a flange portion that spreads from the base periphery of the hollow needle, and the base portion of the elastic sheath body has a flange-like base portion that extends along the surface of the flange portion,
The chemical liquid container connecting portion has a connecting pipe portion configured to be connected to a tubular connecting portion provided in a chemical liquid container to be connected,
On the surface side where the hollow needle of the member body is erected, a vial engaging portion configured to be attached to the mouth portion of the vial is provided,
The member body and the hollow needle are made of polypropylene,
The elastic sheath body is made of a styrene-ethylene-butylene-styrene block copolymer (SEBS), a connecting member with a needle,
A chemical container provided with a tubular connection part,
The connecting pipe part provided in the connecting member with the needle and the tubular connecting part of the chemical liquid container are connected so that the chemical liquid can circulate,
The chemical solution container is provided with a chemical solution outlet for discharging the contained chemical solution,
It is preferable that a hanging tool configured to suspend and support the drug dissolution kit is provided on the connecting member with a needle or the chemical solution container.

The drug dissolution kit according to another aspect of the present invention is as follows.
A member main body in which a hollow needle is erected, and an elastic sheath covering the hollow needle,
On the side opposite to the side where the hollow needle of the member body is erected, there is a connecting member with a needle provided with a chemical solution container connecting portion configured to be connected to a chemical solution container,
The elastic sheath body covers at least the outer surface of the hollow needle so that it can be peeled off,
The elastic sheath body is provided on the outer surface of the hollow needle by a two-color molding method or an insert molding method,
At least the outer surface of the hollow needle covered by the elastic sheath body is guaranteed to be sterilized,
A flat portion is formed at the tip of the elastic sheath body,
The member main body has a flange portion that spreads from the base periphery of the hollow needle, and the base portion of the elastic sheath body has a flange-like base portion that extends along the surface of the flange portion,
The chemical liquid container connecting portion has a connecting pipe portion configured to be connected to a tubular connecting portion provided in a chemical liquid container to be connected,
On the surface side where the hollow needle of the member body is erected, a vial engaging portion configured to be attached to the mouth portion of the vial is provided,
The chemical solution container connection portion has a connection screw portion configured to be screwed to a tubular screw portion provided in the chemical solution container to be connected,
The member body and the hollow needle are made of polypropylene,
The elastic sheath body is made of a styrene-ethylene-butylene-styrene block copolymer (SEBS), a connecting member with a needle,
A chemical container provided with a tubular screw part,
The connection screw part provided in the connecting member with the needle and the tubular screw part of the chemical liquid container are connected by screwing so that the chemical liquid can circulate,
The chemical solution container is provided with a chemical solution outlet for discharging the contained chemical solution,
It is preferable that a hanging tool configured to suspend and support the drug dissolution kit is provided on the connecting member with a needle or the chemical solution container.

The drug dissolution kit according to another aspect of the present invention is as follows.
A member main body in which a hollow needle is erected, and an elastic sheath covering the hollow needle,
On the side opposite to the side where the hollow needle of the member body is erected, there is a connecting member with a needle provided with a chemical solution container connecting portion configured to be connected to a chemical solution container,
The elastic sheath body covers at least the outer surface of the hollow needle so that it can be peeled off,
The elastic sheath body is provided on the outer surface of the hollow needle by a two-color molding method or an insert molding method,
At least the outer surface of the hollow needle covered by the elastic sheath body is guaranteed to be sterilized,
A flat portion is formed at the tip of the elastic sheath body,
The member main body has a flange portion that spreads from the base periphery of the hollow needle, and the base portion of the elastic sheath body has a flange-like base portion that extends along the surface of the flange portion,
The chemical liquid container connecting portion has a connecting pipe portion configured to be connected to a tubular connecting portion provided in a chemical liquid container to be connected,
On the surface side where the hollow needle of the member body is erected, a vial engaging portion configured to be attached to the mouth portion of the vial is provided,
The chemical solution container connection portion has a connection screw portion configured to be screwed to a tubular screw portion provided in the chemical solution container to be connected,
The member body and the hollow needle are made of polypropylene,
The elastic sheath body is made of a styrene-ethylene-butylene-styrene block copolymer (SEBS), a connecting member with a needle,
A chemical container provided with a tubular screw part,
The connection screw portion provided in the connection member with the needle and the tubular screw portion of the chemical solution container are connected so as to be detachable, and both the connection screw portion and the tubular screw portion are of a luer lock type. It is preferable.

  The present invention relates to a connecting member with a needle configured so that another vial can be connected to the drug solution container, and a drug dissolving kit in which the connecting member with a needle and the drug solution container are connected.

  DESCRIPTION OF SYMBOLS 1 ... Connection member with a needle, 2 ... Hollow needle, 3 ... Member main body, 4 ... Elastic sheath body, 5 ... Through-hole, 6 ... Vial bottle, 7 ... Mouth part, 8 ... Vial bottle engaging part, 9 ... Projection piece DESCRIPTION OF SYMBOLS 10 ... Engagement nail | claw, 11 ... Flange part, 12 ... Connection pipe part (chemical solution container connection part), 13 ... Flange-like base part, 14 ... Plane part, 15 ... Connection screw part (chemical solution container connection part), 16 ... Screw 17: Connecting member with needle, 18 ... Drug, 20 ... Drug dissolution kit, 21 ... Tubular connecting part, 22 ... Chemical solution container, 23 ... Chemical solution, 24 ... Joint, 25 ... Chemical solution outlet, 26 ... Plug body, 27 ... Suspension tool, 27a ... Hole, 28 ... Heater, 29 ... Protrusion, 30 ... Syringe, 31 ... Tubular screw part, 31a ... Screw part, 32 ... Chemical solution, 33 ... Rubber sealant, 34 ... Piston member, 35 ... Drug dissolution kit, 36 ... Luer lock type line.

Claims (17)

A member main body in which a hollow needle is erected, and an elastic sheath covering the hollow needle,
On the side opposite to the side where the hollow needle of the member body is erected, there is a connecting member with a needle provided with a chemical solution container connecting portion configured to be connected to a chemical solution container,
The elastic sheath covers the molten resin in a state of being in close contact with the outer surface of the hollow needle so that at least the outer surface of the hollow needle can be peeled off,
A connecting member with a needle for connecting a chemical solution container, wherein at least the outer surface of the hollow needle covered with the elastic sheath body is guaranteed to be sterilized.   The connecting member with a needle for connecting a chemical solution container according to claim 1, wherein the elastic sheath body is provided on the outer surface of the hollow needle by a two-color molding method.   The connecting member with a needle for connecting a chemical solution container according to claim 1, wherein the elastic sheath body is provided on an outer surface of the hollow needle by an insert molding method.   The connecting member with a needle for connecting a chemical solution container according to any one of claims 1 to 3, wherein molding conditions of the elastic sheath body are within a range of a resin temperature of 150 to 250 ° C.   The connecting member with a needle for connecting a chemical solution container according to any one of claims 1 to 4, wherein a flat portion is formed at a tip of the elastic sheath body.   The said member main body has a flange part extended from the base part peripheral edge of the said hollow needle, and has a flange-like base part where the base part of the said elastic sheath body spreads along the surface of the said flange part. 6. A connecting member with a needle for connecting a chemical liquid container according to any one of 5 above.   The said chemical | medical solution container connection part has a connecting pipe part comprised so that it could connect with the tubular connection part provided in the chemical | medical solution container to connect, The chemical | medical solution container of any one of Claims 1-6 Connection member with connecting needle.   The vial engaging portion configured to be fitted with a mouth portion of a vial is provided on the surface side of the member main body where the hollow needle is erected. The connecting member with a needle for connecting a chemical liquid container according to Item.   The chemical solution according to any one of claims 1 to 8, wherein the chemical solution container connection portion includes a connection screw portion configured to be screwed to a tubular screw portion provided in a chemical solution container to be connected. Connection member with needle for container connection.   A connecting member with a needle for connecting a chemical liquid container according to any one of claims 1 to 8, a chemical container with a tubular connecting part, a connecting pipe part provided on the connecting member with a needle, and a chemical liquid A drug dissolution kit, which is connected to a tubular connection part of a container so that a drug solution can flow.   A connecting member with a needle for connecting a chemical liquid container according to claim 9 and a chemical liquid container provided with a tubular screw part, wherein the connecting screw part provided in the connecting member with a needle and the tubular screw part of the chemical liquid container are A drug dissolution kit connected by screwing so that a chemical solution can be distributed.   The drug dissolution kit according to claim 10 or 11, wherein the drug solution container is provided with a drug solution outlet for discharging a stored drug solution.   The drug dissolution kit according to claim 10 or 12, wherein a hanging member configured to suspend and support the drug dissolution kit is provided on the connection member with the needle for connecting the drug solution container or the drug solution container. A connecting member-out drug container connection with needle according to claim 9, and a drug solution container tubular threaded portion is provided, said tubular of the drug solution container and the connection screw portion provided in the needle having connecting members The drug dissolution kit, wherein the screw part is detachably connected, and the connection screw part and the tubular screw part are both of a luer lock type. A member main body on which a hollow needle is erected and an elastic sheath covering the hollow needle are provided, and a surface of the member main body opposite to the side on which the hollow needle is erected can be connected to a chemical solution container. A method for manufacturing a connecting member with a needle for connecting a chemical liquid container provided with a configured chemical liquid container connecting part,
The elastic sheath is formed on the outer surface of the hollow needle by a two-color molding method or an insert molding method, and is provided so as to cover at least the outer surface of the hollow needle in a state of being in close contact with the outer surface of the hollow needle. The manufacturing method of the connection member with a needle | hook for chemical | medical solution container connection which has a process.   The method for producing a connecting member with a needle for connecting a drug solution container according to claim 15, wherein at least the outer surface of the hollow needle covered with the elastic sheath body is sterilized by the step of molding the elastic sheath body. The method for producing a connecting member with a needle for connecting a chemical solution container according to claim 15 or 16, wherein molding conditions in the step of molding the elastic sheath body are within a range of a resin temperature of 150 to 250 ° C.

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