Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1998-05-22
2001-05-01
Yasko, John D. (Department: 3734)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S905000
Reexamination Certificate
active
06224568
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a dual-chamber type injector accommodating two components, an injection drug and its dissolving liquid, within, respectively, a syringe and a hermetically closed container such as a vial or the like separately from each other and to a connector used for this dual-chamber type injector. More specifically, it is directed to an injector and a connector used therefor, the injector being compact in shape but able to assuredly retain sterility while being stored and to mix both of the accommodated components surely through a simple operation just before administration. Further, the injector is unlikely to damage the sharpness of an injection needle during a mixing operation and is capable of removing the syringe simply after the mixing operation.
2. Description of the Prior Art
Some of the drugs to be administered by injection change in quality over time if dissolved in a dissolving liquid or the like. Therefore, generally a powder injection drug is stored in a dry state and mixed with and dissolved in a dissolving liquid just before administering it.
Ordinarily, the powder injection drug and its dissolving liquid are hermetically packed, for example, in, respectively, a vial and an ampul separately from each other. When they are used for administration, first an injector sucks the dissolving liquid within the ampul and pours it into the vial to dissolve the powder injection drug therein, and then sucks the dissolved drug again. However, these mixing and dissolving operations are troublesome. Besides, an injection needle pierces a vial's closure member in contact with the air, so that it is not easy to keep the injection needle and the mixed injection drug sterile.
In order to solve the above problems, there exists, for example, an injector previously proposed and disclosed in Japanese Patent Public Disclosure No. 5-31189 by the present Applicant as a dual-chamber type injector which incorporates two components and a syringe integrally thereinto so as to facilitate the mixing operation in a sterile state.
The above-mentioned conventional dual-chamber type injector, for example, as shown in
FIG. 32
, has a syringe
83
accommodating a first powder component
81
slidably inserted from an opening
87
provided at a rear end of an external cylinder
86
and hermetically seals a drug accommodating chamber
85
within the syringe
83
by embedding a front end of an injection needle
84
in a sealing member
88
provided at a front end of the external cylinder
86
. The external cylinder
86
supports a hermetically closed container
89
which includes a container chamber
96
accommodating a second liquid component
82
. A closure member
91
attached to a takeout port
90
of the container
89
is intimately contacted with the sealing member
88
and a cover
92
is attached to the opening
87
at the rear end of the external cylinder
86
so as to airtightly cover the syringe
83
.
The cover
92
has a flange portion
93
formed with an annular easily-broken portion
94
.
With the foregoing dual-chamber type injector
80
, when an external force is applied to a rear end of the cover
92
, for example, by pushing the external cylinder
86
onto a desk from above, the easily broken portion
94
breaks. If it is further pushed, a piston
95
is pressed to increase the inner pressure of the drug accommodating chamber
85
and at the same time relatively move the syringe
83
while sliding it toward the container
89
. Then the front end of the injection needle
84
enters the container chamber
96
by piercing the sealing member
88
and the closure member
9
1
, thereby allowing gas to flow from the drug accommodating chamber
85
into the container chamber
96
to result in increasing the pressure within the container chamber
96
.
Next, if the foregoing pushing force is cancelled, the increased pressure within the container chamber
96
retracts the piston
95
and causes the second liquid component
82
to flow into the drug accommodating chamber
85
through the injection needle
84
. The first powder component
81
is mixed with and dissolved in this flowed-in second component
82
.
Subsequently, excessive gas flowed into the syringe
83
is discharged by operating the piston
95
and then the syringe
83
is extracted from the external cylinder
86
to be used for drug administration.
3. Problems Presented by the Prior Art
The conventional dual-chamber type injector has the following problems:
(1) Since the hermetically closed container is arranged ahead of the injection needle attached to the front end of the syringe through the sealing member, the injector becomes large in its entire length and is therefore bulky when stored.
(2) A metal injection needle is fixed to the front end of the syringe; it is not easy to dispose of the metal injection needle separately from the other non-metallic portions after the injector is used.
(3) The drug accommodating chamber is communicated with the container chamber through a slot within the injection needle. Accordingly, the drug or the like does not readily move and therefore requires much time for movement. In addition, the powder drug clogs the slot to interrupt the communication between the drug accommodating chamber and the container chamber, causing a fear of failure to assuredly mix both components.
(4) When mixing both the components, the injection needle has to pierce through the sealing member and the closure member. This is likely to produce rubber dust or the like when piercing and to decrease the sharpness of the injection needle. Accordingly, the injection needle cannot easily pierce the skin of a patient and additionally may give great pain to the patient.
(5) When the syringe is dismantled from the connector after the mixing operation, it is necessary to straightly extract the injection needle from the sealing member or the closure member so as not to apply an excessive external force to the injection needle, and therefore a careful operation is needed.
SUMMARY OF THE INVENTION
The present invention has a technical object of solving the foregoing problems and providing a dual-chamber type injector and a connector used therefor. The dual-chamber type injector is compact in shape but can assuredly retain its sterility while being stored and mix both of accommodated components surely through a simple operation just before administration. Further, the injector is unlikely to damage the sharpness of an injection needle when conducting the mixing operation and has a syringe to be easily removed after the mixing operation.
In order to solve the foregoing problems, the present invention has constructed a dual-chamber type injector and a connector used therefor as follows.
A first invention relates to a dual-chamber type injector comprising a syringe
1
including a drug accommodating chamber
3
which accommodates a first component
11
and having a needle connecting portion
4
with an injection needle
10
not yet attached thereto. The needle connecting portion
4
is arranged opposite to a takeout port
6
of a hermetically closed container
5
including a container chamber
5
a
which accommodates a second component
12
. The syringe
1
is connected and fixed to the container
5
through a connector
13
so as to be movable in proximity mutually. At least the syringe
1
is adapted to be separable from the connector
13
, there being provided a communication passage
14
capable of communicating the drug accommodating chamber
3
with the container chamber
5
a
. The communication passage
14
is cut off by a closure member
7
a
,
7
b
arranged between both of the chambers
3
and
5
a
. The syringe
1
and the container
5
can be moved in proximity to each other, thereby displacing at least part of the closure member
7
,
7
a
,
7
b
so as to be able to open the communication passage
14
.
According to the first invention, the closure member cuts off the communication passage provided between the drug accommodating chamber and the cont
Morimoto Shuji
Okochi Kazuhiro
Tanaka Nobuyoshi
Wakamatsu Kotaro
Takeda Chemical Industries Ltd.
Wenderoth , Lind & Ponack, L.L.P.
Yasko John D.
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