Pre-filled syringe

Details Pre-filled syringe Pre-filled syringe

2000-10-18

2003-04-08

Mendez, Manuel (Department: 3763)

Surgery

Means for introducing or removing material from body for...

Treating material introduced into or removed from body...

C604S220000, C604S089000

Reexamination Certificate

active

06544233

ABSTRACT:

BACKGROUND OF THE INVENTION
The present invention relates to a medicine-containing syringe (pre-filled syringe) in which two kinds of medicines are separately sealed. More particularly, the present invention relates to a pre-filled syringe which has a simple construction, can be produced easily, can store two kinds of medicines, for example, a first solution and a second solution or a solution and an powder reliably, separately, and for a long time, allows uniform and rapid mixing the two kinds of medicines to be accomplished in administering to a patient or mixing to other medicine, and can be used sanitarily and conveniently.
To mix medicines with each other, medicines accommodated in ampoule bottles or vial bottles are sucked up with a needle and then mixed each other. To inject a medicine to a patient, the medicine is sucked up with a needle. In recent years, to prevent microbism and foreign matter-caused pollution in an injection time or medicine-mixing time and reduce time and labor, widely used are a packed syringe into which sterilized medicine has been filled and a packed pre-filled syringe sterilized after a medicine is filled thereinto. As the pre-filled syringe, in addition to a one-solution type pre-filled syringe containing one kind of medicine, a two-chamber type pre-filed syringe containing two kinds of medicines separately in two chambers is known widely.
Most of the known two-chamber type pre-filled syringes have a construction shown in
FIG. 5A. A
cylindrical part
22
is partitioned into two chambers
25
,
26
with two gaskets
23
,
24
; powdery or granular medicine (powder) A is sealed in the chamber
25
located at the front side of the cylindrical part
22
; A solution B (solvent or solution for powdery or granular medicine sealed in chamber
25
) is sealed in the chamber
26
located at the rear side of the cylindrical part
22
. Otherwise, different kinds of solutions A and B are sealed in the chambers
25
and
26
, respectively.
FIG. 5
shows the case in which the powder is sealed in the chamber
25
and the solution is sealed in the chamber
26
.
In using the two-chamber type pre-filled syringe shown in
FIG. 5A
, a cap is removed from the syringe and an injection needle is attached to the syringe. A plunger
27
installed on the gasket
24
is pressed. The gaskets
23
,
24
and the solution B sealed in the chamber
26
located between both gaskets
23
,
24
move forward. When the gasket
23
moves to a bypassing projection
28
formed radially outwardly at a portion of the cylindrical part
22
, a gap (duct)
29
is formed between the peripheral surface of the gasket
23
and the inner peripheral surface of the cylindrical part
22
. Through the gap (duct)
29
, the solution B flows into the chamber
25
in which the medicine (powder) A and the solution B are mixed with each other (dissolution of the powder A into the solution B) to form a mixed solution. The plunger
27
is pressed forward further to move the gaskets
23
,
24
forward further to inject the mixed solution to a patient through an injection needle installed at the front end of the cylindrical part
22
.
For commercialization, normally, the solution which is used for injection is sterilized with high-pressure vapor. The powder and the granule are liable to melt or modify when they are sterilized with the high-pressure vapor. Thus, they are sterilized by a different treatment (aseptic filling treatment or the like). Therefore, as the conventional methods of producing the two-chamber type pre-filled syringe, shown in
FIG. 5A
, containing the powder sealed in the chamber
25
and the solution sealed in the chamber
26
, the following two methods (1) and (2) are carried out:
Method (1): Referring to
FIG. 6
, with the solution B sealed in a cylindrical member
22
b
that composes the cylindrical part
22
by using the gaskets
23
and
24
or the gasket
23
and other sealing means (not shown), the solution B is sterilized with high-pressure vapor. Then, the powder A prepared separately is filled into a cylindrical member
22
a
that also composes the cylindrical part
22
. Thereafter, the cylindrical member
22
a
and the cylindrical member
22
b
are connected in an aseptic atmosphere to compose the cylindrical part
22
.
Method (2): Referring to
FIG. 7
, the cylindrical part
22
c
whose both ends are open is prepared. With the solution B sealed in the cylindrical part
22
by using the gaskets
23
and
24
or the gasket
23
and other sealing means (not shown), the solution B is sterilized with high-t pressure vapor. Then, the powder A prepared separately in an aseptic atmosphere is introduced into the cylindrical part
22
c
from the opening at the front end thereof. Thereafter, a nozzle
30
of the syringe is installed on the cylindrical part
22
at the front end thereof.
However, the methods (1) and (2) are complicated in the producing process and much time and labor are required. In particular, the method (1) requires a high technique in connecting the cylindrical member
22
b
sealing the solution B therein and the cylindrical member
22
a
sealing the powder therein to each other accurately.
The methods (1) and (2) are adopted to produce the two-chamber type pre-filled syringe sealing the solution that can be sterilized with high-pressure vapor in one chamber and the solution susceptible to heat in the other chamber. In this case, a similar problem occurs.
In the conventional two-chamber type pre-filled syringe shown in
FIG. 5
, let it be supposed that the plunger
27
is pressed too strongly by mistake while the powder A and the solution B are being mixed with each other (see
FIG. 5B
) and that the gasket
23
passes the bypass
28
and rapidly moves to a position forward therefrom. In this case, the gap (duct)
29
is closed before the entire solution B flows into the chamber
25
sealing the powder A. Consequently, the solution B and the powder A are not mixed completely with each other. Thus, much care should be taken in using the two-chamber type pre-filed syringe. That is, the two-chamber type pre-filled syringe is not easy to handle.
As another problem of the conventional two-chamber type pre-filled syringe shown in
FIG. 5
, the gasket
23
which has moved to the position of the bypass
28
during mixing of the solution B and the powder does not move to a rearward position of the cylindrical part
22
when the solution B flows into the chamber
25
. Therefore, the chamber
25
should be designed to be large (length and diameter, namely, capacity) to flow the whole amount of the solution B into the chamber
25
and mix the solution B and the powder A sufficiently with each other in the chamber
25
. Consequently, the entire two-chamber type pre-filled syringe becomes necessarily large. Further, the syringe consists of only the outer cylinder and the entire length of the syringe is long. Therefore, there is a room for improvement to allow the syringe to be compact to save energy and handled easily and conveniently in injection and discarding times. In the conventional two-chamber type pre-filled syringe shown in
FIG. 5
, there is one which is so designed that the gasket
23
and the gasket
24
are pressed to move toward the front end of the syringe while air is missing. It is possible that liquid leakage occurs in the syringe at the time of a mixing operation.
It is an object of the present invention to provide a two-chamber type pre-filled syringe that has a small number of component parts, can be produced in simple producing and assembling processes and with high productivity, and is safe and sanitary.
It is another object of the present invention to provide a two-chamber type pre-filled syringe which is capable of easily and sufficiently mixing two kinds of medicines separately sealed therein without requiring skill so that a mixed solution is used for injection to a patient or to a medical container.
It is still another object of the present invention to provide a two-chamber type pre-filled syringe that is compact to save energy and to be handled easil

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