PH12014502543B1

PH12014502543B1 - Needle-equipped connecting member, and drug dissolution kit

Info

Publication number: PH12014502543B1
Application number: PH12014502543A
Authority: PH
Inventors: Hiroya IWAHORI
Original assignee: Ea Pharma Co Ltd
Priority date: 2012-05-17
Filing date: 2014-11-14
Publication date: 2015-01-21
Also published as: KR20180037071A; KR20150014474A; CN104271104B; PH12014502543A1; JP6234225B2; CN104271104A; WO2013172449A1; IN2014DN09433A; JPWO2013172449A1

Abstract

The present invention provides a needle-equipped connecting member (1) including a member body (3) on which a hollow needle (2) is erected and an elastic sheath (4) which covers the hollow needle (2), in which a drug solution container-connecting portion (12) constituted to be able to be connected to a drug solution container (22) is disposed at the side opposite to the side of the member body (3) on which the hollow needle (2) is erected, and the elastic sheath (4) covers the hollow needle (2) in a state of being in close contact with and being removable from at least the outer surface of the hollow needle (2). The present invention also provides a drug dissolution kit (35) using the needle-equipped connecting member (1). According to the present invention, when the drug dissolution kit (35) is used, a sterilization process can be performed simply.

Description

the elastic sheath which covers the hollow needle, if a molfen resin is molded into the elastic sheath in a state of being in close contact with the outer surface of the hollow needle, ’ atleast the outer surface of the hollow needle covered with the elastic sheath can be sterilized, hence sterility of this portion can be guaranteed. Consequentially, when the needle-equipped connecting member is used as a drug dissolution kit, a sterilization process can be performed simply.

The drug dissolution kit of the present invention has a constitution in which the drug solution container-connecting portion of the needle-equipped connecting member is connected to a drug solution container. Accordingly, sterility of at least the outer surface of the hollow needle covered with the elastic sheath can be guaranteed. Consequentially, ’ when the drug dissolution kit is used, a sterilization process can be performed simply.

Brief Description of Drawings 15 .

FIG. 1 is a front cross-sectional view showing a first example of a needle-equipped connecting member of the present invention.

FIG. 2 is a schematic view of a hollow needle.

FIG. 3 is a front cross-sectional view showing a state where a vial is mounted on the needle-equipped connecting member.

FIG. 4 is a front cross-sectional view showing a second example of the needle-equipped connecting member of the present invention.

FIG. 5 is a front cross-sectional view showing a first example of a drug dissolution kit of the present invention.

FIG. 6 is a front cross-sectional view showing a production process of the drug dissolution kit.

FIG. 7 is a front cross-sectional view showing a state where the drug dissolution kit is used.

FIG. 8 is a front cross-sectional view of a drug dissolution kit having a hanger.

FIG. 9 is a front cross-sectional view showing a first example of a method of attaching the hanger.

FIG. 10 is a front cross-sectional view showing a second example of the method of attaching the hanger.

oo EEE EEE EEE ——————————— rie ee eee eee eee eset =e ese esse eee eee 9

FIG. 11 is a front cross-sectional view showing a second exemplary production process of the drug dissolution kit of the present invention.

FIG. 12 is a front cross-sectional view showing a second exemplary state where the drug dissolution kit of the present invention is used. 5 .

Description of Embodiments

Hereinafter, embodiments of the present invention will be described with reference to drawings.

The constitutions of needle-equipped connecting members and a drug dissolution kit described below are merely examples of the present invention. The present invention is not limited to those examples and can be modified and altered in various ways. (Needle-equipped connecting member) .

FIG. 1 is a view showing a first example of a needle-equipped connecting member of the present invention.

A needle-equipped connecting member 1 of this example includes a member body 3 on which a hollow needle 2 is erected and an elastic sheath 4 which covers the hollow needle 2, in which a vial engagement portion 8 constituted to make an opening portion 7 of avial 6 mounted thereon is disposed at one side of the member body 3 on which the hollow needle 2 is erected; a connecting tube portion 12 (drug solution container-connecting portion) constituted to be able to be connected to a drug solution container is disposed at the other side of the member body 3; and the elastic sheath 4 covers the hollow needle in a : state of being in close contact with and removable from at least the outer surface of the hollow needle 2.

In this example, the member body 3 has a flange portion 11 which widens from the rim of a base portion of the hollow needle 2, and a base portion of the elastic sheath 4 has a flange-like base portion 13 which widens along the surface of the flange portion 11.

Because the flange-like base portion 13 which widens along the surface of the flange portion 11 is disposed in this way, when the vial 6 is mounted on the needle-equipped connecting member, the uppermost side of an opening portion 7 composed of an aluminum cap or the like comes into contact with the flange-like base portion 13 composed of an elastic resin. As a result, the flange-like base portion 13 functions as a cap, whereby leakage of the solution from this portion can be prevented.

The base portion of the hollow needle 2 refers to the bottom portion of the hollow needle 2 having a through-hole 5 at the tip portion thereof, and is a site positioned at the central portion of the flange portion 11.

The base portion of the elastic sheath 4 refers to a portion of the elastic sheath that is on the base portion of the hollow needle 2, and is a site positioned at the central portion of the elastic sheath 4 of the flange portion 11.

At the side of the member body 3 on which the hollow needle 2 is erected, the vial engagement portion 8, which is composed of two or more projections 9 protruding upward from the rim of the flange portion 11, is disposed.

In each of the projections 9, a locking claw 10 is formed, which is engaged with the opening portion 7 of the vial 6 when the vial 6 is mounted on the needle-equipped connecting member 1 as shown in FIG. 3.

The member body 3 and the hollow needle 2 are in the form of an integrally molded article made of a synthetic resin. It is important for the needle to maintain its shape even when it punctures a stopper of the vial 6. Accordingly, as the synthetic resin, a high-rigidity resin suited for Japanese Pharmacopoeia such as polyethylene, polypropylene, polycarbonate, an ABS resin, or an AS resin is preferably used, and among these, polypropylene is more preferable.

The hollow needle 2 is not particularly limited in terms of the dimensions, the shape of the tip, and the like thereof, as long as the needle is constituted to be able to puncture the stopper disposed in the opening portion 7 of the vial 6.

For example, as shown in FIG. 2, the hollow needle 2 may have the shape of a hollow cylinder having a sharp tipped portion. | :

When the hollow needle 2 having the shape shown in FIG. 2 is used, a diameter ¢a ofthe hollow needle 2 is preferably about 2.5 mm to 3.5 mm; a cylinder portion length b is preferably about 7.0 mm to 8.0 mm; and a hollow needle height ¢ is preferably about 15 mm to 17 mm.

a 1m

One end of the through-hole 5, which is formed in the hollow needle 2, is opened in the tip portion of the hollow needle 2, and the other end thereof is opened at the other side of the member body 3. Moreover, the through-hole 5 has a diameter that enables the circulation of a drug solution. 5 .

The material of the elastic sheath 4 is a resin suited for Japanese Pharmacopoeia, and as the material, thermoplastic elastomers applicable to injection can be used.

Examples thereof include a styrene-ethylene-butylene-styrene block copolymer (SEBS), a styrene-ethylene-propylene-styrene block copolymer (SEPS), hydrogenated styrene-butadiene rubber (HSBR), styrene-ethylene-butadiene rubber (SEBR), a block copolymer composed of crystalline polyolefin block-ethylene block-butylene block-crystalline polyolefin block (CEBC), an ethylene/vinyl alcohol copolymer (EVOH), polyethylene, and the like.

When the material of the member body 3 and the hollow needle 2 is . polypropylene, as the material of the elastic sheath 4, a styrene-ethylene-butylene-styrene block copolymer (SEBS) or a mixed material thereof is preferably used. Alternatively, in order to make the elastic sheath 4 exhibit appropriate removability with respect to the hollow needle 2, it is preferable to mix a styrene-ethylene-butylene-styrene block copolymer (SEBS) with an ethylene/vinyl alcohol copolymer (EVOH) or polyethylene (PE).

The elastic sheath 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 body 3. The tip of the ) elastic sheath 4 does not match with the shape of the tip of the hollow needle 2 and has a planar portion 14 that is in the form of a flat surface. The thickness of the elastic sheath 4 covering the tip of the hollow needle 2 is set such that the needle tip does not protrude therefrom by mistake, and such that the thickness does not cause resistance at the time of puncturing the stopper of the vial 6. Generally, the thickness is preferably from 1 mm to 10 mm, and more preferably from 1 mm to 5 mm.

The tip of the elastic sheath 4 refers to a site having the planar portion 14 which does not enter the vial 6 and tolerates mounting resistance so as to make the elastic sheath 4 be removed by utilizing the resistance occurring at the time of mounting the vial 6.

If the planar portion 14 is disposed at the tip of the elastic sheath 4, when the vial ee 12 6 is mounted on the vial engagement portion 8, an operation is smoothly conducted, in which the elastic sheath 4 is removed from the tip portion of the hollow needle 2, the . hollow needle 2 protrudes out through the planar portion 14 of the elastic sheath 4, punctures the stopper of the vial 6, and enters the vial 6. Ifthere is no planar portion 14, or alternatively, if the outer diameter of the planar portion 14 is small, there is a possibility that the elastic sheath 4 may enter the vial 6 without being removed from the hollow needle 2. In order to prevent such a case from occurring, the outer diameter of the planar portion 14 is preferably made equal to or greater than a diameter a of the hollow needle 2.

The needle-equipped connecting member 1 of this example is preferably produced through a two-color molding method by using the resin material of the member . body 3 including the hollow needle 2 and the resin material of the elastic sheath 4.

The two-color molding method is a molding technique of integrally molding different materials in combination. The two-color molding method in the production method of the needle-equipped connecting member 1 of this example includes a step of molding the member body 3 including the hollow needle 2 and a step of integrally molding a portion which is to be the elastic sheath 4 with the member body 3 in the same die as the hollow needle 2 after molding of the member body 3. The production method of the elastic sheath 4 includes a step of inserting the hollow needle 2 into a cavity which is to be the elastic sheath 4 while rotating the die in a state where the molded member body 3 and the hollow needle 2 are left in the same core, and a step of pouring a material which is to be the elastic sheath 4 through a gate of the cavity of the elastic sheath 4. By using the two-color molding method, the needle-equipped connecting member 1 of this example becomes a product in which the member body 3 including the hollow needle 2 has been integrated with the elastic sheath 4. The order of molding is not limited to the above, and the elastic sheath 4 can be molded first.

As the production method of the needle-equipped connecting member 1 of the present application, an insert molding method can also be adopted in addition to the aforementioned method.

In the insert molding method, the member body 3 is molded first, the member body 3 is then placed in the cavity of the elastic sheath 4, and the different materials are integrally molded.

In the insert molding method, only the member body 3 can be molded first and set aside.

In the insert molding method, in order to make the elastic sheath 4 be more effectively removed, the surface portion of the hollow needle 2 can be coated with silicon oil before the member body 3 is integrated with the elastic sheath 4. In the insert molding method, coating of silicon oil can be easily performed before the elastic sheath 4 is integrated with the member body 3 (this is because only the member body 3 is set aside in advance in the insert molding method).

In the insert molding method, as the site which is to be coated with the silicon oil, the surface portion of the hollow needle 2 including the needle tip but excluding the flange portion 11 is preferable. If the flange portion 11 is not coated with silicon oil, it is possible to prevent the elastic sheath 4 from being removed.

In producing the needle-equipped connecting member 1 by means of the : two-color molding method or the insert molding method, the molding conditions of the member body 3 including the hollow needle 2 are preferably within a range of a resin temperature of 180°C to 300°C. Furthermore, the molding conditions of the elastic sheath 4 are preferably within a range of a resin temperature of 150°C to 250°C.

Examples

The results of molding tests of needle-equipped connecting members produced by insert molding will be shown below.

First, hollow needles (PP) were injection-molded, and then elastic sheaths composed of resins mixed as described in the following Table 1 were molded. Asaresult, the elastic sheaths were removed in the state shown in Table 1.

The retractility and removability of the needle-equipped connecting members were evaluated by sensory evaluation by actually mounting the vial 6 on the needle-equipped connecting member 3.

When the elastic sheath 4 is removed from the hollow needle 2, only the hollow needle 2 needs to be inserted into the vial 6 while the elastic sheath 4 is being removed from the hollow needle 2. At this time, the elastic sheath 4 is not inserted into the vial 6 and is compressed in a gap formed when the vial 6 is mounted on the needle-equipped

C14 connecting member 3. The retractility of the needle-equipped connecting member 3 at this time relates to whether the elastic sheath 4 can be easily compressed in the gap formed when the vial 6 is mounted on the needle-equipped connecting member 3.

The retractility of the needle-equipped connecting member 3 was evaluated based on the following criteria.

A: The elastic sheath 4 can be easily compressed.

B: Although the elastic sheath 4 can be compressed, more pressing energy is required at the time of mounting compared to the level A.

C: The elastic sheath 4 is hard and is not easily compressed.

The removability of the needle-equipped connecting member 3 was evaluated based on the following criteria.

A: The elastic sheath 4 is easily removed from the hollow needle 2.

B: Although the elastic sheath 4 is relatively easily removed from the hollow needle 2, more energy is required at the time of mounting compared to the level A.

C: Although the elastic sheath 4 is removed from the hollow needle 2, more energy is required at the time of mounting compared to the level B.

D: The elastic sheath 4 cannot be removed from the hollow needle 2. [Table 1]

Mixing Coating of SEBS EVOH |PE Retractility | Removability oe fae | RR

Not 100% | 0% 0% C ee | FF 2 Not 0% 100% 0% Cc lee CFF 3 Not 0% 0% 100% | C =

Not 50% 50% 0% C

N= ll i 5 Not 90% 0% ‘10% A

B= A A

[rem [wor [oc J JAJA

When the needle-equipped connecting member 1 is produced by the two-color molding method or the insert molding method, a molten elastic resin is supplied to the Co outer surface of the hollow needle 2 of the member body 3 so as to mold the elastic sheath 4. Atthis time, the temperature of the outer surface of the hollow needle 2 becomes high since the outer surface comes into contact with the molten resin, and consequentially, at least the outer surface of the hollow needle 2 becomes sterile.

Accordingly, in the obtained needle-equipped connecting member 1, as long as the elastic sheath 4 remains intact, sterility of at least the outer surface of the hollow needle 2 can be guaranteed. .

Sterilization means an operation for creating a state where the odds that a microorganism may survive in a sterilized substance are equal to or lower than a million to one (that is, among 1,000,000 sterilized objects, the number of the sterilized substance in which a microorganism may exist is equal or less than 1). In the present application, the outer surface portion of the molded hollow needle 2 is brought into contact with the molten elastic resin at a high temperature so as to mold the elastic sheath 4. Therefore, at least the outer surface of the hollow needle 2 is sterilized and is in a so-called sterile state. That is, the sterility of at least the outer surface of the hollow needle 2 can be guaranteed.

At the tip portion of the hollow needle 2, the through-hole 5 is formed, and via the through-hole 5, a drug solution comes into contact with the outer surface of the hollow needle 2. The hollow needle 2 and the elastic sheath 4 are not completely welded together Co except for the flange portion 11. Accordingly, via the through-hole 5, moist heat, which is generated when a drug solution is sterilized, can enter the portion of elastic sheath which is not welded. In the present application, the sterilization is an operation of reducing the odds that a microorganism that clings to the sterilized substance, that is, a microorganism that clings to at least the outer surface of the hollow needle 2 may survive, by making the needle-equipped connecting member 1 .be in the aforementioned situation.

FIG 3 is a view showing a state where the vial 6 containing a drug is mounted on the needle-equipped connecting member 1. As the vial 6, it is possible to use a type of vial which is commonly used in the medical field and has a stopper constituted to be able to be punctured at the uppermost side of the opening portion 7.

When the vial 6 is mounted, if the stopper at the uppermost side of the opening portion 7 of the vial 6 is exposed, and the opening portion 7 is pushed into the vial oC engagement portion 8 of the needle-equipped connecting member 1, the vial 6 can be mounted simply.

At the time of mounting the vial, when the stopper of the vial 6 comes into contact with the tip of the hollow needle 2 through the elastic sheath 4, and thus pressure is applied thereto, the stopper hits the tip of the hollow needle 2 through the elastic sheath 4.

Furthermore, through the pressure applied to the tip of the hollow needle 2, the elastic sheath 4 is removed from the outer surface of the tip portion of the hollow needle 2, and the tip of the hollow needle 2 protrudes out through the elastic sheath 4, punctures the stopper, and is inserted into the vial 6.

The opening portion 7 of the vial 6 advances toward the flange portion 11 while widening two or more projections 9 outward, and each of the locking claws 10 goes over the opening portion 7 and reaches a diameter-reduced portion of the mouth of the vial. : Thereafter, each of the projections 9 is elastically restored, and each of the locking claws 10 is engaged with the mouth and holds the vial 6.

In the state where the vial 6 is being held by locking claws 10, the hollow needle 2 penetrates the stopper and reaches the inside of the vial 6. As a result, via the through-hole 5 of the hollow needle 2, the inside of the vial 6 enters into communication with the inside of the connecting tube portion 12.

The needle-equipped connecting member 1 of this example includes the member body 3 on which the hollow needle 2 is erected and the elastic sheath 4 which covers the hollow needle 2, and has a constitution in which the vial engagement portion 8 constituted to enable the opening portion 7 of the vial 6 to be mounted thereon is disposed at one side of the member body 3 on which the hollow needle 2 is erected; the connecting tube portion 12 (drug solution container-connecting portion) constituted to be able to be connected to a drug solution container is disposed at the other side of the member body 3; and the elastic sheath 4 covers the hollow needle in a state of being in close contact with and being removable from at least the outer surface of the hollow needle 2. Therefore, when the elastic sheath 4 covering the hollow needle 2 is formed, if the elastic sheath 4 is molded in a state where a molten resin is brought into close contact with the outer surface of the hollow needle, at least the outer surface of the hollow needle 2 covered with the elastic sheath 4 can be sterilized, and the sterility of this portion can be guaranteed. Consequentially, when the needle-equipped connecting member 1 is used as a drug dissolution kit, a sterilization process can be performed simply.

FIG. 4 is a view showing a second example of a needle-equipped connecting member of the present invention.

A needle-equipped connecting member 17 of this example is composed of substantially the same constituents as the needle-equipped connecting member 1 of the first example described above, and the same constituents are marked with the same reference signs.

In the needle-equipped connecting member 17 of this example, as a drug solution container-connecting member, a connecting screw portion 15, in which a screw portion 16 (male screw) is formed on the outer circumferential surface of a tubular material, is disposed instead of the connecting tube portion 12.

When a prefilled syringe-type drug solution container having a tubular screw portion is used, the connecting screw portion 15 is screwed into the tubular screw portion of the drug solution container, whereby the needle-equipped connecting member 17 is detachably connected to the drug solution container.

The state where the connecting screw portion 15 is screwed into the tubular screw portion of the drug solution container means that the connecting screw portion 15 is connected to the tubular screw portion of the drug solution container by being screwed thereinto.

The example illustrated in FIG. 4 shows a constitution in which the screw portion 16 as a male screw is formed on the outer circumferential surface of the connecting screw portion 15. However, in order to make the needle-equipped connecting member 17 suited for a type of drug solution container in which a male screw is formed in a tubular screw portion, it may be constituted with a connecting screw portion, in which a female screw is formed on the inner circumferential surface of a tubular material, as the connecting screw portion 15.

oo - 18

The needle-equipped connecting member 17 of this example exerts substantially the same effects as the needle-equipped connecting member 1 of the first example described above, and has the connecting screw portion 15 which can be detachably connected to the tubular screw portion of the drug solution container. Therefore, the needle-equipped connecting member 17 enables switching or replacement of drug solution containers and can thus diversify the mode of using the drug dissolution kit. (Drug dissolution kit)

FIG. 5 is a view showing a first example of a drug dissolution kit of the present invention. | :

A drug dissolution kit 20 of this example includes the aforementioned needle-equipped connecting member 1 and a drug solution container 22, and has a constitution in which the connecting tube portion 12 disposed in the needle-equipped connecting member 1 is connected to the tubular connecting portion 21 of the drug solution container 20.

In the drug solution container 22, a drug solution 23 is sealed and filled in a container body made of a synthetic resin. At one end of the container body, the tubular connecting portion 21 is disposed, and the needle-equipped connecting member 1 is welded and joined to the tip of the tubular connecting portion 21. Furthermore, at the other end of the container body, a drug solution outlet 25 for discharging the drug solution 23 accommodated in the container is disposed, and a stopper 26 is disposed in the opening of the drug solution outlet 25.

The connecting tube portion 12 of the needle-equipped connecting member 1 is welded and joined to the tubular connecting portion 21 of the drug solution container 20 by a junction 24. When the connecting tube portion 12 of the needle-equipped connecting member 1 and the tubular connecting portion 21 of the drug solution container 20 are constituted with the same type of synthetic resin, for example, polypropylene or the like, the connecting portions can be simply welded together by heating and melting the end of both the connecting tube portion 12 and the tubular connecting portion 21. The method for connecting the connecting tube portion 12 to the tubular connecting portion 21 is not

-— 19 limited to joining by welding, and a connection method using an appropriate connecting member such as a joint member may also be adopted.

FIG. 6 is a view showing a production process of the drug dissolution kit 20 of this example. -

When producing the drug dissolution kit 20, the needle-equipped connecting member 1 and the drug solution container 22 are separately prepared by molding (FIG. 6(a)). The drug solution container 22 does not contain the drug solution 23 and is empty, and the drug solution outlet 25 is opened.

Next, as shown in FIG. 6(b), the end of the tubular connecting portion 21 of the drug solution container 22 and the end of the connecting tube portion 12 of the needle-equipped connecting member 1 are heated and caused to face each other, thereby welding and joining the connecting portions together.

Subsequently, the drug solution 23 is injected into the container from the drug solution outlet 25 of the drug solution container 22, and then as shown in FIG 6(c), a sealing body 26 is mounted on the opening of the drug solution outlet 25 to seal the drug solution container 22. In this manner, the drug dissolution kit 20 is prepared. The production process of the drug dissolution kit 20 is not limited to the production process shown in FIG. 6. In the production process, the sealing body 26 may be mounted on the drug solution container 22, the drug solution may be filled into the drug solution container from the tubular connecting portion 21, and then the needle-equipped connecting member 1 may be connected to the drug solution container.

Thereafter, the drug dissolution kit 20 is subjected to a sterilization treatment (FIG. 6(d)). The drug solution accommodated in the drug solution container 22 is sterilized by a sterilization treatment such as high-pressure steam sterilization or the like. At this time, because the inside of the drug solution container 22 is in communication with the through-hole 5 of the hollow needle 2, the drug solution 23 and the inside of the hollow needle 2 are sterilized at the same time.

FIG. 7 is a view showing how to use the drug dissolution kit 20 in medical facilities. nr

In the drug dissolution kit 20, the opening portion 7 of the vial 6 filled with a desired drug 18 is pushed into side of the hollow needle 2 of the needle-equipped connecting member 1 shown in FIG. 7(a). As a result, the inside of the vial 6 enters into .- communication with the inside of the drug solution container 22, and thus the drug 18 can be mixed with the drug solution 23.

As shown in FIG. 7(b), after the opening portion 7 of the vial 6 is pushed into the side of the hollow needle 2, when the stopper of the vial 6 comes into contact with the tip of the hollow needle 2 through the elastic sheath 4, and thus pressure is applied thereto, the stopper hits the tip of the hollow needle 2 through the elastic sheath 4. Furthermore, through the pressure applied to the tip of the hollow needle 2, the elastic sheath 4 is removed from the outer surface of the tip portion of the hollow needle 2, and the tip of the hollow needle 2 protrudes out through the elastic sheath 4 and punctures the stopper, - whereby the hollow needle 2 is inserted into the vial 6.

When the hollow needle 2 is inserted into the vial 6, the through-hole 5 is also exposed in the vial 6 simultaneously. As a result, the inside of the vial 6 and the inside of the drug solution container 22 enter into communication with each other via the through-hole 5 of the hollow needle 2. If the drug dissolution kit 20 is lifted up in this state, the drug solution 23 is injected into the vial 6. By the drug solution being injected into the vial 6, the drug 18 accommodated in the vial 6 is dissolved (or dispersed).

Thereafter, if the drug dissolution kit 20 is lowered, the drug solution containing the drug - in the vial 6 moves into the drug solution container 22 via the through-hole 5.

The drug solution 23 containing the drug 18 is supplied into the body or the like of a patient, through a solution delivery line or the like which is connected to the drug solution container 22 by penetrating the stopper 26.

The drug dissolution kit 20 has a constitution in which the needle-equipped connecting member 1 is connected to the drug solution container 22. Accordingly, the sterility of at least the outer surface of the hollow needle 2 covered with the elastic sheath 4 can be guaranteed. Consequentially, when the drug dissolution kit 20 is used, a oC sterilization process can be performed simply.

FIG. 8 is a view showing an example including a hanger 27 which is constituted to enable the drug dissolution kit 20 to be supported by being hung thereon.

C= ———————— 21

In this example, the drug dissolution kit 20 has a constitution in which the band-like hanger 27 made of a synthetic resin is used such that both ends of the hanger 27 are attached to the outer surface of the member body 3 of the needle-equipped connecting member 1. The joining position of the hanger 27 is not limited to this example. The hanger 27 may be joined to the side of the drug solution container 22, or alternatively, . hangers having various shapes other than the band-like hanger may be used.

FIG. 9 is a view showing a first example of a method of attaching the hanger 27.

In this example, the end of the hanger 27 is superposed on the outer surface of the member body 3 of the needle-equipped connecting member 1, and a heater 28 is brought close to the portion to heat it. As a result, the end of the hanger 27 is welded to the outer surface of the member body 3. :

FIG. 10 is a view showing a second example of a method of attaching the hanger : 27.

In this example, at both ends of the hanger 27, a hole 27a for attachment is formed.

Moreover, a mushroom-like bump 29 having a head portion, which is constituted to be able to be inserted into the hole 27a, is disposed on the outer surface of the member body 3.

When the bump 29 on the outer surface of the member body 3 is inserted into the hole 27a ofthe hanger 27, both ends of the hanger 27 can be attached onto the outer surface of the member body 3 of the needle-equipped connecting member 1.

FIG. 11 is a front cross-sectional view showing a second exemplary production oo process of the drug dissolution kit of the present invention.

As shown in FIG. 11(e), a drug dissolution kit 35 of this example is constituted with the needle-equipped connecting member 17 having a constitution in which the connecting screw portion 15 is disposed as shown in FIG. 4; a syringe 30 (drug solution container) in which a drug solution 32 is sealed by a rubber sealant 33; and a piston : member 34 of which the tip side is inserted into the syringe 30. In the tip portion of the syringe 30, a tubular screw portion 31 having a screw portion 31a (female screw) on the inner circumferential surface thereof is disposed. The connecting screw portion 15 of the needle-equipped connecting member 17 is inserted and screwed into the tubular screw portion 31, and thus the needle-equipped connecting member 17 is connected to the syringe 30. The connection portion of the tubular screw portion 31 and the connecting screw portion 15 may be provided with an O-ring for preventing leakage of the solution.

The state where the connecting screw portion 15 is screwed into the tubular screw portion 31 means that the connecting screw portion 15 is connected to the tubular screw portion 31 by being screwed into the tubular screw portion 31.

When producing the drug dissolution kit 35, the separately molded syringe 30 and the needle-equipped connecting member 17 are prepared. Thereafter, as shown in FIG 11(a), the connecting screw portion 15 of the needle-equipped connecting member 17 is fitted into the tubular screw portion 31 of the syringe 30 and screwed in the mounting direction indicated by the arrow in the drawing. :

As shown in FIG 11(b), after the connecting screw portion 15 of the needle-equipped connecting member 17 is completely screwed into the tubular screw portion 31 of the syringe 30, and thus the needle-equipped connecting member17 is connected to the syringe 30, the drug solution 32 is injected into the syringe 30 as shown in

FIG. 11(c).

Next, as shown in FIG. 11(d), the inside of the syringe 30 is plugged by the rubber sealant 33 so as to seal the drug solution 32 in the syringe 30, and the whole kit is sterilized by heating.

Thereafter, as shown in FIG. 11(e), the piston member 34 for moving the rubber sealant 33 from the rear end side of the syringe 30 is mounted, and thereby the drug dissolution kit 35 is obtained.

FIG. 12 is a view illustrating how to use the drug dissolution kit 35 of this example.

In order to mix the drug solution 32 of the drug dissolution kit 35 with another drug in the vial 6, as shown in FIG. 12(a), the opening portion 7 of the vial 6 is pushed into the vial engagement portion 8 of the needle-equipped connecting member 17 of the drug dissolution kit 35. Through this pushing operation, the hollow needle 2 protrudes out through the elastic sheath 4 and the stopper disposed on the uppermost surface of the vial 6 enters the vial 6. Thereafter, the piston member 34 of the syringe 30 is pushed so as to inject a portion of the drug solution 32 or the entirety of the drug solution 32 into the vial 6, and the drug in the vial 6 is dissolved by shaking. Subsequently, the piston member 34 of

TE

23 the syringe 30 is pulled such that the drug solution 32 containing the drug in the vial 30 is aspirated into the syringe 30.

Next, as shown in FIG. 12(b), the vial 6 is removed from the vial engagement portion 8 of the needle-equipped connecting member 17.

Thereafter, the needle-equipped connecting member 17 is turned in a direction in which it is separated from the syringe 30, thereby removing the needle-equipped connecting member 17 from the syringe 30 (FIG. 12(c)).

Subsequently, as shown in FIG. 12(d), the tubular screw portion 31 of the syringe 30 is connected to a luer-lock type line 36, and the drug solution containifig the drug in the syringe 30 is co-infused. : The “luer-lock type” refers to a method in which the line 36 molded into the shape of a screw matching with the tubular screw portion 31 is connected to the screw portion 31, in a manner in which it can be screwed and fixed into the tubular screw portion 31.

The drug dissolution kit 35 has a constitution in which the needle-equipped connecting member 17 is connected to the syringe 30. Accordingly, the sterility of at least the outer surface of the hollow needle 2 covered with the elastic sheath 4 can be guaranteed.

Consequentially, a sterilization process can be performed simply.

Furthermore, the drug dissolution kit 35 has a constitution in which the needle-equipped connecting member 17 is detachably connected to the syringe 30 asa. drug solution container. Accordingly, by removing the needle-equipped connecting member 17 from the syringe 30 after a drug is dissolved in a drug solution, the mode of using the drug dissolution kit can be diversified.

A needle-equipped connecting member of another aspect of the present invention isa needle-equipped connecting member including a member body on which a hollow needle is erected and an elastic sheath which covers the hollow needle, in which a drug solution container-connecting portion constituted to be able to be connected to a drug solution container is disposed at the side opposite to the side of the member body on which the hollow needle is erected, the elastic sheath preferably covers the hollow needle in a state of being in close contact with and being removable from at least the outer surface of the hollow needle,

oo EEE ———————————— ——————————————————————————————— —————————————————————— 24 the elastic sheath is preferably disposed on the outer surface of the hollow needle by a two-color molding method or an insert molding method, the sterility of at least the outer surface of the hollow needle covered with the elastic sheath is preferably guaranteed, a planar portion is preferably formed at the tip of the elastic sheath, the member body preferably has a flange portion which widens from the rim of a : base portion of the hollow needle, and a base portion of the elastic sheath preferably has a flange-like base portion which widens along the surface of the flange portion, the drug solution container-connecting portion preferably has a connecting tube portion constituted to be able to be connected to a tubular connecting portion disposed in a drug solution container which is to be connected, a vial engagement portion constituted to form an opening portion of a vial mounted thereon is preferably disposed at the side of the member body on which the hollow needle is erected, : the drug solution container-connecting portion preferably has a connecting screw portion constituted to be able to be screwed into a tubular screw portion disposed in a drug solution container which is to be connected, the member body and the hollow needle are preferably composed of polypropylene, and the elastic sheath is preferably composed of a styrene-ethylene-butylene-styrene block copolymer (SEBS).

A drug dissolution kit of another aspect of the present invention is a : needie-equipped connecting member including a member body on which a hollow needle is erected and an elastic sheath which covers the hollow needle, in which a drug solution container-connecting portion constituted to be able to be connected to a drug solution container is disposed at the side opposite to the side of the member body on which the hollow needle is erected, the elastic sheath preferably covers the hollow needle in a state of being in close contact with and being removable from at least the outer surface of the hollow needle, the elastic sheath is preferably disposed on the outer surface of the hollow needle by a two-color molding method or an insert molding method, the sterility of at least the outer surface of the hollow needle covered with the oo EEE —me————————————————————————————————————————————————————— 25 elastic sheath is preferably guaranteed, a planar portion is preferably formed at the tip of the elastic sheath, oT the member body preferably has a flange portion which widens from the rim of a base portion of the hollow needle, and a base portion of the elastic sheath preferably has a flange-like base portion which widens along the surface of the flange portion, the drug solution container-connecting portion preferably has a connecting tube portion constituted to be able to be connected to a tubular connecting portion disposed in a drug solution container which is to be connected, a vial engagement portion constituted to form an opening portion of a vial mounted thereon is preferably disposed at the side of the member body on which the hollow needle is erected, : the member body and the hollow needle are preferably composed of polypropylene, the elastic sheath preferably includes a needle-equipped connecting member which is composed of a styrene-ethylene-butylene-styrene block copolymer (SEBS) and a drug solution container having a tubular connecting portion, the connecting tube portion disposed in the needle-equipped connecting member is preferably connected to the tubular connecting portion of the drug solution container so as to enable circulation of a drug solution, the drug solution container preferably has a drug solution outlet for discharging a ' drug solution accommodated in the container, and a hanger constituted to enable the drug dissolution kit to be supported by being hung thereon is preferably disposed in either the needle-equipped connecting member or the drug solution container. ’

A drug dissolution kit of another aspect of the present invention is a needle-equipped connecting member including a member body on which a hollow needle is erected and an elastic sheath which covers the hollow needle, in which a drug solution container-connecting portion constituted to be able to be connected to a drug solution container is disposed at the side opposite to the side of the member body on which the hollow needle is erected, the elastic sheath preferably covers the hollow needle in a state of being in close contact with and being removable from at least the outer surface of the hollow needle,

the elastic sheath is preferably disposed on the outer surface of the hollow needle by a two-color molding method or an insert molding method, the sterility of at least the outer surface of the hollow needle covered with the : elastic sheath is preferably guaranteed, a planar portion is preferably formed at the tip of the elastic sheath, the member body preferably has a flange portion which widens from the rim of a : base portion of the hollow needle, and a base portion of the elastic sheath preferably has a flange-like base portion which widens along the surface of the flange portion, the drug solution container-connecting portion preferably has a connecting tube portion constituted to be able to be connected to a tubular connecting portion disposed in a drug solution container which is to be connected, a vial engagement portion constituted to make an opening portion of a vial mounted thereon is preferably disposed at the side of the member body on which the hollow needle is erected, the drug solution container-connecting portion preferably has a connecting screw ; portion constituted to be able to be screwed into a tubular screw portion disposed in a drug solution container which is to be connected, the member body and the hollow needle are preferably composed of polypropylene, the elastic sheath preferably includes a needle-equipped connecting member which is composed of a styrene-ethylene-butylene-styrene block copolymer (SEBS) and a drug solution container having a tubular screw portion, the connecting screw portion disposed in the needle-equipped connecting member is preferably connected to the tubular screw portion of the drug solution container so as to enable circulation of a drug solution, the drug solution container preferably has a drug solution outlet for discharging a drug solution accommodated in the container, and a hanger constituted to enable the drug dissolution kit to be supported by being hung thereon is preferably disposed in either the needle-equipped connecting member or the drug solution container.

A drug dissolution kit of another aspect of the present invention is a needle-equipped connecting member including a member body on which a hollow needle is erected and an elastic sheath which covers the hollow needle, in which a drug solution container-connecting portion constituted to be able to be connected to a drug solution container is disposed at the side opposite to the side of the member body on which the hollow needle is erected, the elastic sheath preferably covers the hollow needle in a state of being in close i contact with and being removable from at least the outer surface of the hollow needle, the elastic sheath is preferably disposed on the outer surface of the hollow needle by a two-color molding method or an insert molding method, the sterility of at least the outer surface of the hollow needle covered with the elastic sheath is preferably guaranteed, : a planar portion is preferably formed at the tip of the elastic sheath, the member body preferably has a flange portion which widens from the rim of a : base portion of the hollow needle, and a base portion of the elastic sheath preferably has a flange-like base portion which widens along the surface of the flange portion, . the drug solution container-connecting portion preferably has a connecting tube portion constituted to be able to be connected to a tubular connecting portion disposed in a drug solution container which is to be connected, a vial engagement portion constituted to form an opening portion of a vial mounted thereon is preferably disposed at the side of the member body on which the hollow needle is erected, the drug solution container-connecting portion preferably has a connecting screw portion constituted to be able to be screwed into a tubular screw portion disposed in a drug solution container which is to be connected, : the member body and the hollow needle are preferably composed of polypropylene, the elastic sheath preferably includes a needle-equipped connecting member which is composed of a styrene-ethylene-butylene-styrene block copolymer (SEBS) and a drug solution container having a tubular screw portion, the connecting screw portion disposed in the needle-equipped connecting member is preferably detachably connected to the tubular screw portion of the drug solution container, and both the connecting screw portion and the tubular screw portion are preferably luer-lock types.

Title of Invention

NEEDLE-EQUIPPED CONNECTING MEMBER, AND DRUG DISSOLUTION KIT

Technical Field

The present invention relates to a needle-equipped connecting member constituted to enable a drug solution container to be connected to another vial, and a drug dissolution kit in which the needle-equipped connecting member is connected to the drug solution container.

Priority is claimed on Japanese Patent Application No. 2012-113517, filed May 17, 2012, the content of which is incorporated herein by reference.

Background Art

In the related art, regarding drug dissolution kits, for example, the techniques disclosed in PTLS 1 to 3 have been suggested.

PTL 1 discloses a drug dissolution kit constituted of a drug solution container and avial holder, in which the drug solution container has a communication port that is formed in the upper portion of the body of the container and a drug solution outlet that is formed in the lower portion of the body of the container, in which a connecting member is formed at the upper end of the communication port; a sealing body is mounted on the lower end of the outlet; a vial-mounting port and a medical needle are disposed in the vial holder such that they protrude from the inner surface of the bottom of the body of the holder; and the bottom of the body of the holder is connected to the connecting member of the drug solution container.

PTL 2 discloses a double-ended needle-equipped dissolving solution container including a pressure-deformable dissolving solution container body made of plastic that has an opening portion closed by a sealing portion on the upper portion thereof, a double-ended needle that is positioned above the opening portion and includes a pair of an upper needle body and a lower needle body in which hollow portions in communication

Industrial Applicability

Reference Signs List 1---needle-equipped connecting member, 2--hollow needle, 3--member body, 4.---¢lastic sheath, 5---through-hole, 6--vial, 7--opening portion, 8--vial engagement portion, 9---projection, 10---fixing claw, 11---flange portion, 12.-connecting tube portion (drug solution container-connecting portion), 13.--flange-like base portion, 14---planar portion, 15---connecting screw portion (drug solution container-connecting portion), 16--screw portion, 17---needle-equipped connecting member, 18---drug, 20---drug dissolution kit, 21---tubular connecting portion, 22---drug solution container, 23---drug solution, 24---connection portion, 25---drug solution outlet, 26---stopper, 27---hanger, 27a--hole, 28---heater, 29---bump, 30---syringe, 31--tubular screw portion, 31a---screw portion, 32--drug solution, 33---rubber sealant, 34---piston member, 35---drug dissolution kit, 36--luer-lock type line with each other are formed, a drug vial that is positioned above the double-ended needle and has a sealed opening portion at the lower end thereof, and a protection cap that extends upward so as to cover the double-ended needle and the drug vial while concentrically surrounding the opening portion of the dissolving solution container and is mounted so as tobe removable from the opening portion as appropriate. When the sealing portion of the opening portion of the drug vial inside the protection cap is pressed on the upper needle body, the needle bodies of the double-ended needle slide on the protection cap. Asa result, the sealing portion of the opening portion of the dissolving solution container is punctured by the lower needle body, and the sealing portion of the opening portion of the drug vial is punctured by the upper needle body, and consequentially, the needle bodies are inserted into both of the containers. Furthermore, the needle bodies have a length that enables drugs to move down into the container through the needle bodies, whenever both of the containers are turned upside down following the insertion of the needle bodies.

PTL 3 discloses a transfusion container including a container body made of flexible plastic that is filled with a drug solution such as a dissolving solution or a diluent and has means for communication with another drug solution container and a drug solution outlet respectively. The means for communication includes, as constituents, a puncture needle that is in communication with the inside of the container body and can puncture an opening portion of another drug container, and a support member that is concentrically and integrally combined with the puncture needle and can support another drug container at the time of communication. The puncture needle is capped with a protection cap including a rubber inner layer composed of a rubber member. In the capped state, the rubber inner layer of the protection cap forms a seal around the puncture needle, whereby the puncture needle is kept sterilized or kept in a liquid-tight state. Between the protection cap and means for communication, there is a restriction mechanism that restricts the protection cap so as to maintain the capped state. By turning the protection cap, the restriction mechanism can be selectively placed in a restriction position and a non-restriction position.

Citation List

Patent Literature

[PTL 1] Japanese Unexamined Patent Application, First Publication No.

H10-33635 [PTL2] Japanese Unexamined Utility Model Application, First Publication No.

H6-22272 [PTL 3] Japanese Unexamined Patent Application, First Publication No.

H8-24313

Summary of Invention Technical Problem

However, the background art described above has the following problems.

The drug dissolution kit described in PTL 1 is connected to a needle portion which is an assembly of a plurality of molded articles. Accordingly, the drug dissolution kit has a problem in that it is not easy to guarantee sterility of the needle portion during a sterilization process of a dissolving solution portion, and the needle needs to be sterilized by gamma ray sterilization or the like, and thus the production cost increases.

In the double-ended needle-equipped dissolving solution container described in

PTL 2, the double-ended needle needs to puncture the stoppers of both the vial and the solution container, hence the operation is cumbersome. Furthermore, coring may occur twice. In addition, the container has a problem of high cost due to the complicated structure thereof.

The transfusion container described in PTL 3 is a type of drug dissolution kit in which the needle cap is removed and the needle is exposed before it punctures the stopper ofthe vial. Therefore, the transfusion container has problems in that sterility of the needle is not guaranteed if the needle is exposed beforehand, and the container is dangerous because the needle tip is exposed.

The present invention has been made in consideration of the above circumstances, and objects thereof are to provide a needle-equipped connecting member which can simplify a sterilization process when being used as a drug dissolution kit, and to provide a drug dissolution kit using the same.

Solution to Problem :

In order to achieve the above objects, for example, the present invention provides a needle-equipped connecting member including a member body on which a hollow needle is erected, and an elastic sheath which covers the hollow needle, in which a drug solution container-connecting portion constituted to be able to be connected to a drug solution container is disposed at the side opposite to the side of the member body on which the hollow needle is erected, and the elastic sheath covers the hollow needle in a state of being . in close contact with and being removable from at least the outer surface of the hollow needle.

In the needle-equipped connecting member of the present invention, the elastic sheath is preferably disposed on the outer surface of the hollow needle by a two-color molding method.

In the needle-equipped connecting member of the present invention, at least the outer surface of the hollow needle covered with the elastic sheath has preferably a o- sterilization assurance.

In the needle-equipped connecting member of the present invention, a planar portion is preferably formed at the tip of the elastic sheath.

In the needle-equipped connecting member of the present invention, the member body preferably has a flange portion which widens from the rim of a base portion of the hollow needle, and a base portion of the elastic sheath preferably has a flange-like base portion that widens along the surface of the flange portion. .

In the needle-equipped connecting member of the present invention, the drug solution container-connecting portion preferably has a connecting tube portion which can be connected to a tubular connecting portion disposed in a drug solution container which is to be connected.

In the needle-equipped connecting member of the present invention, a vial engagement portion on which an opening portion of a vial is mounted is preferably disposed at the side of the member body on which the hollow needle is erected.

In the needle-equipped connecting member of the present invention, the drug solution container-connecting portion is preferably constituted with a connecting screw portion which can be screwed into the tubular screw portion disposed in the drug solution container which is to be connected.

The present invention also provides a drug dissolution kit including the needle-equipped connecting member and a drug solution container having a tubular : connecting portion, in which the connecting tube portion disposed in the needle-equipped connecting member is connected to the tubular connecting portion of the drug solution container so as to enable circulation of a drug solution.

Furthermore, the present invention provides a drug dissolution kit including the needle-equipped connecting member and a drug solution container having a tubular screw portion, in which the connecting screw portion disposed in the needle-equipped connecting : member is screwed into and connected to the tubular screw portion of the drug solution container so as to enable circulation of a drug solution.

In the drug dissolution kit of the present invention, the drug solution container preferably has a drug solution outlet for discharging a drug solution accommodated in the drug solution container.

In the drug dissolution kit of the present invention, a hanger, which is constituted to enable the drug dissolution kit to be supported by being hung thereon, is preferably disposed in either the needle-equipped connecting member or the drug solution container.

Moreover, the present invention provides a drug dissolution kit including the needle-equipped connecting member and the drug solution container having the tubular screw portion, in which the connecting. screw portion disposed in the needle-equipped connecting member is detachably connected to the tubular screw portion of the drug solution container, and both the connecting screw portion and the tubular screw portion are luer-lock types.

The present invention also has the following aspects. (1) A needle-equipped connecting member including a member body on which a hollow needle is erected and an elastic sheath which covers the hollow needle, in which a drug solution container-connecting portion constituted to be able to be connected to a drug solution container is disposed at the side opposite to the side of the member body on which the hollow needle is erected, and the elastic sheath covers the hollow needle in a state of being in close contact with and being removable from at least the outer surface of the hollow needle;

(2) The needle-equipped connecting member described in (1), in which the elastic sheath is disposed on the outer surface of the hollow needle by a two-color molding method;

(3) The needle-equipped connecting member described in (1), in which the elastic sheath is disposed on the outer surface of the hollow needle by an insert molding method;

(4) The needle-equipped connecting member described in any one of (1) to (3), in which sterility of at least the outer surface of the hollow needle covered with the elastic sheath is guaranteed;

(5) The needle-equipped connecting member described in any one of (1) to (4), in which a planar portion is formed at the tip of the elastic sheath; .

(6) The needle~equipped connecting member described in any one of (1) to (5), in which the member body has a flange portion which widens from the rim of a base portion of the hollow needle, and a base portion of the elastic sheath has a flange-like base portion which widens along the surface of the flange portion;

(7) The needle-equipped connecting member described in any one of (1) to (6), in which the drug solution container-connecting portion has a connecting tube portion constituted to be able to be connected to a tubular connecting portion disposed in a drug solution container which is to be connected;

(8) The needle-equipped connecting member described in any one of (1) to (7), in : which a vial engagement portion constituted to make an opening portion of a vial mounted thereon is disposed at the side of the member body on which the hollow needle is erected;

(9) The needle-equipped connecting member described in any one of (1) to (8), in which the drug solution container-connecting portion has a connecting screw portion constituted to be able to be screwed into the tubular screw portion disposed in the drug ee 7 solution container which is to be connected; (10) A drug dissolution kit including the needle-equipped connecting member described in any one of (1) to (8) and a drug solution container having a tubular connecting portion, in which the connecting tube portion disposed in the needle-equipped connecting member is connected to the tubular connecting portion of the drug solution container so as oC to enable circulation of a drug solution; (11) A drug dissolution kit including the needle-equipped connecting member described in (9) and a drug solution container having a tubular screw portion, in which the connecting screw portion disposed in the needle-equipped connecting member is connected to the tubular screw portion of the drug solution container by being screwed into the tubular screw portion so as to enable circulation of a drug solution; (12) The drug dissolution kit described in (10) or (11), in which the drug solution container has a drug solution outlet for discharging a drug solution accommodated in the drug solution container; oo (13) The drug dissolution kit described in (10) or (12), in which a hanger, which is constituted so as to enable the drug dissolution kit to be supported by being hung thereon, is disposed in either the needle-equipped connecting member or the drug solution container; and (14) A drug dissolution kit including the needle-equipped connecting member described in (9) and a drug solution container having a tubular screw portion, in which the connecting screw portion disposed in the needle-equipped connecting member is detachably connected to the tubular screw portion of the drug solution container, and both the connecting screw portion and the tubular screw portion are luer-lock types. oo

Advantageous Effects of Invention

The needle-equipped connecting member of the present invention includes a member body on which a hollow needle is erected and an elastic sheath which covers the hollow needle, and is constituted such that a drug solution container-connecting portion constituted to be able to be connected to a drug solution container is disposed at the side opposite to the side of the member body on which the hollow needle is erected, and the elastic sheath covers the hollow needle in a state of being in close contact with and being removable from at least the outer surface of the hollow needle. Accordingly, in forming

Claims

1. A needle-equipped connecting member comprising: a member body on which a hollow needle is erected; and an elastic sheath which covers the hollow needle, wherein a drug solution container-connecting portion constituted to be able to be connected to a drug solution container is disposed at the side opposite to the side of the member body on which the hollow needle is erected, the elastic sheath covers the hollow needle with a molten resin on the outer surface of the hollow needle in a state of being in close contact with and being removable from at least the outer surface of the hollow needle, and wherein at least the outer surface of the hollow needle covered with the elastic sheath is sterilized.

2. The needle-equipped connecting member according to Claim 1, wherein the elastic sheath is disposed on the outer surface of the hollow needle by a two-color molding method.

3. The needle-equipped connecting member according to Claim 1, wherein the elastic sheath is disposed on the outer surface of the hollow needle by an insert molding method.

4. The needle-equipped connecting member according to any one of Claims 1 to 3, wherein a planar portion is formed at the tip of the elastic sheath.

5. The needle-equipped connecting member according to any one of Claims 1 to 3, wherein the member body has a flange portion which widens from the rim of a base portion of the hollow needle, and a base portion of the elastic sheath has a flange-like base portion which widens along the surface of the flange portion.

6. The needle-equipped connecting member according to any one of Claims 1 to 3, wherein the drug solution container-connecting portion has a connecting tube portion constituted to be able to be connected to a tubular connecting portion disposed in a drug solution container which is to be connected.

7. The needle-equipped connecting member according to Claims 1 to 3, wherein a vial engagement portion constituted to form an opening portion of a vial mounted thereon is disposed at the side of the member body on which the hollow needle is erected.

8. The needle-equipped connecting member according to any one of Claim 1 to 3, wherein the drug solution container-connecting portion has a connecting screw portion constituted to be able to be screwed into the tubular screw portion disposed in the drug solution container which is to be connected.

9. A drug dissolution kit comprising: the needle-equipped connecting member according to any one of Claims 1 to 3; and a drug solution container having a tubular connecting portion, wherein the connecting tube portion disposed in the needle-equipped connecting member is connected to the tubular connecting portion of the drug solution container so as to enable circulation of a drug solution.

10. A drug dissolution kit comprising: the needle-equipped connecting member according to Claim 8; and a drug solution container having a tubular screw portion, wherein the connecting screw portion disposed in the needle-equipped connecting member is connected to the tubular screw portion of the drug solution container by being screwed into the tubular screw portion so as to enable circulation of a drug solution.

11. The drug dissolution kit according to Claim 9, wherein the drug solution container has a drug solution outlet for discharging a drug solution accommodated in the drug solution container.

12. The drug dissolution kit according to Claim 9, wherein a hanger, which is constituted so as to enable the drug dissolution kit to be supported by being hung thereon, is disposed in either the needle-equipped connecting member or the drug solution container.

13. A drug dissolution kit comprising: the needle-equipped connecting member according to Claim 8; and a drug solution container having a tubular screw portion, wherein the connecting screw portion disposed in the needle-equipped connecting member is detachably connected to the tubular screw portion of the drug solution container, and both the connecting screw portion and the tubular screw portion are luer-lock types.