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
10 dissolution kit in which the needle-equipped connecting member is connected to the drug
solution container.
Priority is claimed on Japanese Patent Application No. 2012-1 13517, filed May
17,2012, the content of which is incorporated herein by reference.
15 Background Art
[0002]
In the related art, regarding drug dissolution kits, for example, the techniques
disclosed in PTLS 1 to 3 have been suggested.
[0003]
20 PTL 1 discloses a drug dissolution kit constituted of a drug solution container
and a vial 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
25 lower end of the outlet; a vial-mounting port and a medical needle are disposed in the
2
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.
[0004]
5 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
10 communication 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 to be removable from the opening portion as appropriate.
15 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. As a 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
20 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.
[OOOS]
25 PTL 3 discloses a transfusion container including a container body made of
3
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
5 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
10 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.
15
Citation List
Patent Literature
[0006]
[PTL 11 Japanese Unexamined Patent Application, First Publication No.
20 H10-33635
[PTL 21 Japanese Unexamined Utility Model Application, First Publication No.
H6-22272
[PTL 31 Japanese Unexamined Patent Application, First Publication No.
H8-243 13
25
Summary of Invention
Technical Problem
[0007]
However, the background art described above has the following problems.
5 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
10 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
15 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 of the 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
20 dangerous because the needle tip is exposed.
[OOOS]
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
25 to provide a drug dissolution kit using the same.
Solution to Problem
[0009]
In order to achieve the above objects, for example, the present invention
5 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
10 state of being in close contact with and being removable from at least the outer surface of
the hollow needle.
[OO 101
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
15 molding method.
[OOll]
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
sterilization assurance.
20 [0012]
In the needle-equipped connecting member of the present invention, a planar
portion is preferably formed at the tip of the elastic sheath.
[00 131
In the needle-equipped connecting member of the present invention, the member
25 body preferably has a flange portion which widens from the rim of a base portion of the
6
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.
[0014]
In the needle-equipped connecting member of the present invention, the drug
5 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.
[00 151
In the needle-equipped connecting member of the present invention, a vial
10 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.
[00 161
In the needle-equipped connecting member of the present invention, the drug
solution container-connecting portion is preferably constituted with a connecting screw
15 portion which can be screwed into the tubular screw portion disposed in the drug solution
container which is to be connected.
[00 171
The present invention also provides a drug dissolution kit including the
needle-equipped connecting member and a drug solution container having a tubular
20 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.
[0018]
Furthermore, the present invention provides a drug dissolution kit including the
25 needle-equipped connecting member and a drug solution container having a tubular
7
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.
[00 191
5 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.
[0020]
In the drug dissolution kit of the present invention, a hanger, which is
10 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.
[002 11
Moreover, the present invention provides a drug dissolution kit including the
15 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 her-lock types.
20 [0022]
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
25 drug solution container is disposed at the side opposite to the side of the member body on
8
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 (I), in which the
5 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 (I), in which the
elastic sheath is disposed on the outer surface of the hollow needle by an insert molding
method;
10 (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 ( I ) to (4),
in which a planar portion is formed at the tip of the elastic sheath;
15 (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),
20 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
25 mounted thereon is disposed at the side of the member body on which the hollow needle
9
is erected;
(9) The needle-equipped connecting member described in any one of (1) to (S),
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
5 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
10 container so as to enable circulation of a drug solution;
(1 1) 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
15 into the tubular screw portion so as to enable circulation of a drug solution;
(12) The drug dissolution kit described in (10) or (1 I), in which the drug
solution container has a drug solution outlet for discharging a drug solution
accommodated in the drug solution container;
(13) The drug dissolution kit described in (10) or (12), in which a hanger, which
20 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
25 the connecting screw portion disposed in the needle-equipped connecting member is
10
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.
Advantageous Effects of Invention
5 [0023]
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
10 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
the elastic sheath which covers the hollow needle, if a molten resin is molded into the
elastic sheath in a state of being in close contact with the outer surface of the hollow
15 needle, at least 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.
[0024]
20 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
25 performed simply.
Brief Description of Drawings
[0025]
FIG. 1 is a front cross-sectional view showing a first example of a
5 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
10 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.
15 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.
20 FIG. 10 is a front cross-sectional view showing a second example of the method
of attaching the hanger.
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
25 the drug dissolution kit of the present invention is used.
Description of Embodiments
[0026]
Hereinafter, embodiments of the present invention will be described with
5 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.
10 [0027]
(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
15 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 a vial 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 dmg solution
20 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.
[0028]
In this example, the member body 3 has a flange portion 11 which widens from
25 the rim of a base portion of the hollow needle 2, and a base portion of the elastic sheath 4
13
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
5 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
10 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.
[0029]
15 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
20 connecting member 1 as shown in FIG. 3.
[0030]
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:
25 a high-rigidity resin suited for Japanese Pharmacopoeia such as polyethylene,
14
polypropylene, polycarbonate, an ABS resin, or an AS resin is preferably used, and
among these, polypropylene is more preferable.
[003 11
The hollow needle 2 is not particuIarly limited in terms of the dimensions, the
5 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
10 4a of the hollow needle 2 is preferably about 2.5 rnm to 3.5 mm; a cylinder portion
length b is preferably about 7.0 mm to 8.0 mm; and a hollow needle height c is preferably
about 15 mm to 17 mm.
[0032]
One end of the through-hole 5, which is formed in the hollow needle 2, is
15 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.
[0033]
The material of the elastic sheath 4 is a resin suited for Japanese Pharmacopoeia,
20 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 copolynier (SEPS), hydrogenated
styrene-butadiene rubber (HSBR), styrene-ethylene-butadiene rubber (SEBR), a block
copolymer composed of crystalline polyolefin block-ethylene block-butylene
25 block-crystalline polyolefin block (CEBC), an ethylene/vinyl alcohol copolymer (EVOH),
15
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,
5 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 ethylenelvinyl alcohol copolymer (EVOH) or polyethylene
(PE).
[0034]
10 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
15 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
20 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 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
25 hollow needle 2 protrudes out through the planar portion 14 of the elastic sheath 4,
16
punctures the stopper of the vial 6, and enters the vial 6. If there 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
5 the planar portion 14 is preferably made equal to or greater than a diameter a of the
hollow needle 2.
[003 51
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
10 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
15 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
20 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.
25 [0036]
17
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
5 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
10 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).
15 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
20 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.
25 Examples
[0037]
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
5 composed of resins mixed as described in the following Table 1 were molded. As a
result, the elastic sheaths were removed in the state shown in Table 1.
[003 81
The retractility and removability of the needle-equipped connecting members
were evaluated by sensory evaluation by actually mounting the vial 6 on the
10 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
15 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.
20 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.
[0039]
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 11
Mixing
example
1
2
3
4
When the needle-equipped connecting member 1 is produced by the two-color
Coating of
silicon oil
Not
5
6
molding method or the insert molding method, a molten elastic resin is supplied to the
performed
Not
performed
Not
performed
Not
outer surface of the hollow needle 2 of the member body 3 so as to mold the elastic
SEBS
100%
[0041]
performed
Not
performed
Performed
sheath 4. At this time, the temperature of the outer surface of the hollow needle 2
0%
0%
5 0%
becomes high since the outer surface comes into contact with the molten resin, and
EVOH
0%
90%
100%
consequentially, at least the outer surface of the hollow needle 2 becomes sterile.
100%
0%
50%
Accordingly, in the obtained needle-equipped connecting member 1, as long as
PE
0%
0%
0%
the elastic sheath 4 remains intact, sterility of at least the outer surface of the hollow
0%
100%
0%
Retractility
B
10%
0%
Removability
C
C
C
C
D
D
B
A
A
B
A
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
5 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
10 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 except for the flange portion 11. Accordingly, via the through-hole 5,
15 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
20 aforementioned situation.
[0042]
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
25 able to be punctured at the uppermost side of the opening portion 7.
21
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
engagement portion 8 of the needle-equipped connecting member 1, the vial 6 can be
mounted simply.
5 [0043]
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
10 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.
[0044]
The opening portion 7 of the vial 6 advances toward the flange portion 11 while
15 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.
[0045]
20 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.
[0046]
25 The needle-equipped connecting member 1 of this example includes the member
22
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
5 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,
10 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
15 simply.
[0047]
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
20 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
25 portion 16 (male screw) is formed on the outer circumferential surface of a tubular
23
material, is disposed instead of the connecting tube portion 12.
[0048]
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
5 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
10 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
15 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.
[0049]
The needle-equipped connecting member 17 of this example exerts substantially
20 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.
25 [OOSO]
(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
5 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.
[005 11
10 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
15 solution 23 accommodated in the container is disposed, and a stopper 26 is disposed in
the opening of the drug solution outlet 25.
[0052]
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
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
25 connecting portion 21. The method for connecting the connecting tube portion 12 to the
25
tubular connecting portion 21 is not limited to joining by welding, and a connection
method using an appropriate connecting member such as a joint member may also be
adopted.
[0053]
5 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,
10 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.
15 [0054]
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
20 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.
25 Thereafter, the drug dissolution kit 20 is subjected to a sterilization treatment
26
(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
5 hollow needle 2 are sterilized at the same time.
[0055]
FIG. 7 is a view showing how to use the drug dissolution kit 20 in medical
facilities.
In the drug dissolution kit 20, the opening portion 7 of the vial 6 filled with a
10 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
15 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
20 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.
[0056]
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
25 of the drug solution container 22 enter into communication with each other via the
27
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
5 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.
[0057]
10 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
sterilization process can he performed simply.
15 [OOSS]
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.
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
20 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.
[0059]
25 FIG. 9 is a view showing a first example of a method of attaching the hanger 27.
28
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.
5 [0060]
FIG. 10 is a view showing a second example of a method of attaching the hange~
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
10 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 of the 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.
15 1006 11
FIG. 11 is a front cross-sectional view showing a second exemplary production
process of the drug dissolution kit of the present invention.
As shown in FIG. ll(e), a drug dissolution kit 35 of this example is constituted
with the needle-equipped connecting member 17 having a constitution in which the
20 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 3 1 having a screw portion 3 la (female screw) on the
inner circumferential surface thereof is disposed. The connecting screw portion 15 of
25 the needle-equipped connecting member 17 is inserted and screwed into the tubular
29
screw portion 3 1, and thus the needle-equipped connecting member 17 is connected to
the syringe 30. The connection portion of the tubular screw portion 3 1 and the
connecting screw portion 15 may be provided with an O-ring for preventing leakage of
the solution.
5 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 3 1.
[0062]
When producing the drug dissolution kit 35, the separately molded syringe 30
10 and the needle-equipped connecting member 17 are prepared. Thereafter, as shown in
FIG. I I(a), the connecting screw portion 15 of the needle-equipped connecting member
17 is fitted into the tubular screw portion 3 1 of the syringe 30 and screwed in the
mounting direction indicated by the arrow in the drawing.
As shown in FIG. 1 I (b), after the connecting screw portion 15 of the
15 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. ll(d), the inside of the syringe 30 is plugged by the
20 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. 1 l(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.
25 [0063]
30
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
5 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
10 the vial 6, and the drug in the vial 6 is dissolved by shaking. Subsequently, the piston
member 34 of the syringe 30 is pulled such that the drug solution 32 containing the drug
in the vial 30 is aspirated into the syringe 30.
[0064]
Next, as shown in FIG. 12(b), the vial 6 is removed from the vial engagement
15 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
20 syringe 30 is connected to a luer-lock type line 36, and the drug solution containing 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 3 1 is connected to the screw
portion 3 1, in a manner in which it can be screwed and fixed into the tubular screw
25 portion 3 1.
[0065]
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
5 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 as a
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
10 using the drug dissolution kit can be diversified.
[0066]
Aneedle-equipped connecting member 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
15 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,
20 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,
25 the member body preferably has a flange portion which widens from the rim of a
32
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
5 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
10 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
15 block copolymer (SEBS).
[0067]
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
20 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,
25 the elastic sheath is preferably disposed on the outer surface of the hollow
33
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,
5 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
10 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
15 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
20 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
25 hung thereon is preferably disposed in either the needle-equipped connecting member or
the drug solution container.
[0068]
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
5 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
10 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,
15 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
20 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,
25 the drug solution container-connecting portion preferably has a connecting
3 5
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,
5 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
10 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
15 the drug solution container.
[0069]
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
20 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,
25 the elastic sheath is preferably disposed on the outer surface of the hollow
36
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,
5 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
10 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
15 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
20 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
25 are preferably luer-lock types.
Industrial Applicability
[0070]
The present invention relates to a needle-equipped connecting member
5 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.
Reference Signs List
10 [007 11
1-needle-equipped connecting member, 2-.hollow needle, 3...member body,
4.-elastic 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
15 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, 3 1.-tubular screw portion, 3 lascrew
20 portion, 32-drug solution, 33-rubber sealant, 34-.piston member, 35-drug dissolution
kit, 36-,her-lock type line.

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, 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 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 the sterility of at least the outer surface of the hollow needle covered
with the elastic sheath is guaranteed.
5. The needle-equipped connecting member according to any one of Claims 1
wherein a planar portion is formed at the tip of the elastic sheath.
6. The needle-equipped connecting member according to any one of Claims 1
5 to 5,
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.
10 7. The needle-equipped connecting member according to any one of Claims 1
to 6,
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.

8. The needle-equipped connecting member according to any one of Claims 1
to 7,
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
20 needle is erected.
9. The needle-equipped connecting member according to any one of Claims 1
to 8,
wherein the drug solution container-connecting portion has a connecting screw
25 portion constituted to be able to be screwed into the tubular screw portion disposed in the
drug solution container which is to be connected.
10. A drug dissolution kit comprising:
the needle-equipped connecting member according to any one of Claims 1 to 8;
5 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.
11. A drug dissolution kit comprising:
the needle-equipped connecting member according to Claim 9; and
a drug solution container having a tubular screw portion,
wherein the connecting screw portion disposed in the needle-equipped
15 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 according to Claim 10 or 11,
20 wherein the drug solution container has a drug solution outlet for discharging a
drug solution accommodated in the drug solution container.
13. The drug dissolution kit according to Claim 10 or 12,
wherein a hanger, which is constituted so as to enable the drug dissolution kit to
25 be supported by being hung thereon, is disposed in either the needle-equipped connecting
member or the drug solution container.
14. A drug dissolution kit comprising:
the needle-equipped connecting member according to Claim 9; 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.