Title of Invention

MEDICAL LIQUID CONTAINER AND PREPARATION CONTAINING MEDICAL LIQUID CONTAINER

Abstract To provide a medical liquid container which is free from sealing failure in the seal portion at the peripheral edge of the liquid medicament-housing chamber and also free from deterioration of a medicament housed in a small amount; and a preparation-containing medical liquid container. A secondary liquid medicament-housing chamber 12 is connected to one end of a primary liquid medicament-housing chamber 11. This secondary liquid medicament-housing chamber 12 is unseparably fixed to the primary liquid medicament-housing, chamber 11 at a connection part 14. The secondary liquid medicament-housing chamber 12 has a bulge part 15 bulged such that the internal medicament-housing space before housing a second medicament is larger than the volume of the housed second medicament.
Full Text 1
DESCRIPTION
MEDICAL LIQUID CONTAINER AND PREPARATION-CONTAINING MEDICAL
LIQUID CONTAINER
CROSS-REFERENCE TO RELATED APPLICATIONS
This application claims the benefit pursuant to 35 U.S.C. §119 (e)(l) of U.S.
Provisional Application No. 60/632,951 filed on December 6, 2004, and prioirity is
claimed on Japanese Patent Application No. 2004-342695, filed November 26, 2004, and
Japanese Patent Application No. 2005-327087, filed November 11, 2005, the contents of
which are incorporated herein by reference.
TECHNICAL FIELD
The present invention relates to a medical liquid container for housing a medical
preparation such as drip-feed solution, and a preparation-containing medical liquid
container obtained by housing a medical preparation in the medical liquid container.
BACKGROUND ART
Some medicaments are used alone but in many cases, a plurality of medicaments
are administered in combination to a patient. Particularly, in the case of a liquid
injection administered by transfusion, it is often performed to prepare the injection by
mixing medicaments or co-inject a slight amount of a secondary medicament into the
primary medicament. Such an operation must be sterilely performed. This sterile
dispensing operation is cumbersome and a danger of causing a dispensing failure is
noted. Efforts have been heretofore made to improve this dispensing operation from the

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aspect of medical liquid container and thereby elevate safety and efficiency.
As for the container used in the medical field, a liquid medicament container
where a plurality of contents are housed in a plurality of chambers partitioned in one
container and although respective contents are not mixed before use, the contents can be
easily mixed on use is known. For example, with respect to the liquid medicament
container of preparing a transfusion preparation by mixing multiple species of
medicaments immediately before transfusing the transfusion preparation, a liquid
medicament container with multiple chambers is known, where a seal part produced by
heat-melt bonding inner wall faces of a bag-shaped container formed of a synthetic
resin-made film is used as a partition and medicaments are housed in a plurality of
chambers partitioned by the seal part within the bag-shaped container. In a known
constitution of such a liquid medicament container with multiple chambers, a rupturable
liquidtight plug member is interposed in a part of the partition formed by the seal part
and respective chambers are allowed to communicate by rupturing the liquidtight plug so
that medicaments divided and housed in a plurality of chambers can be mixed.
Also, a container using a peelable weak seal for a part or the entirety of the
partition formed by a seal part is known, where respective chambers are allowed to
communicate by stripping the peelable weak seal by means of pressing or the like and
thereby liquid medicaments divided and housed in multiple chambers can be mixed.
These containers have a constitution such that at the time of performing transfusion by
using the medicaments housed, the partition dividing respective chambers is caused to
allow for communication and create one continuous chamber inside the container.
Out of these liquid medicament containers each with multiple chambers, in a
medical liquid container having a primary medicament-housing chamber and a secondary
medicament-housing chamber for housing a small amount of a medicament as in the case

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where the inner content largely differs among liquid medicaments housed in respective
liquid medicament-housing chambers, when the communicatable partitioning means used
therefor is a weak seal part conventionally employed for a medical liquid container with
two chambers, the production is more facilitated than in the case of using another
partition member and since communication can be attained by pressing one chamber to
increase the inner pressure of the liquid medicament, the liquid medicaments can be
easily mixed on use. Furthermore, the container comprising a sheet material has high
flexibility, requires no air-passing needle, is excellent in hygiene, safety and workability
such that the liquid discharge rate is kept constant throughout transfusion, realizes a
small volume when wasted and ensures volume decrease at the disposal and therefore,
this container is preferred as compared with conventional vials or medical liquid
containers in which the entire is produced by blow molding.
In the medicament-housing chambers partitioned by using a sheet material and
forming a seal part, since the sheet material is flat, the medicament-housing chamber
before charging a medicament is naturally in a state having a volume of nearly 0. The
medical container comprising a sheet material takes an inflated shape for the first time
when a medicament is housed therein and the sheet material is deformed under a pressure
generated due to self-weight of the medicament. Particularly, in the case of a relatively
small-content secondary medicament, when only a small amount of the medicament is
charged, the rigidity of the sheet material surpasses the pressure generated due to
self-weight of the medicament and the container cannot be inflated, as a result, the
medicament is merely spread like a film between sheets over a wide area.
If a small-content medicament is spread over a wide area in this way, at the time
of sealing the secondary medicament-housing chamber by heat sealing, the medicament
itself comes into contact with the heat-sealing part to cause a problem such as sealing

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failure or deterioration of the medicament. In addition, a housing chamber with a large
area is necessary for housing a small amount of a secondary medicament and an
excessively large medical container results to incur a problem of bad usability.
As for the medical container in the case where the inner content ratio among
medicaments housed in respective medicament-housing chambers is large,
JP-A-2002-165864 (the term "JP-A" as used herein means an "unexaminedpublished
Japanese patent application") describes a container in which a peelable weak seal is used
for one partition of a housing container, a plurality of housing containers are joined
through the weak seal part, and medicaments can be mixed on use. However, if a
small-content secondary medicament chamber partitioned by a seal partition is formed in
a medical container comprising a sheet material, a large area must be ensured for the
secondary medicament chamber, as a result, the medical container as a whole becomes
very large and its usability is bad.
JP-A-2003-159309 describes a container in which a relatively small secondary
medicament-housing container part is formed by using a cylindrical injection molded
member and can be joined with a primary medicament container part by the same
technique as used for joining a cylindrical port for liquid discharge. However, in order
to attain communication between the secondary medicament-housing chamber formed by
using an injection molded member and the primary medicament chamber, a part of the
injection molded member dividing these two chambers must be fractured to remove the
partition, and the force for this communication operation must be suppressed to such an
extent of allowing for almost no generation of fine pieces, particles or the like or not
disturbing the transfusion. Therefore, the design and production of the injection molded
member and the management of production become very difficult.
Furthermore, in the case where two or more secondary medicaments are used

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and these medicaments cannot be mixed in advance during storage but must be mixed on
use, secondary medicament-housing container parts prepared as many as the number of
secondary medicaments by using the injection molded member must be joined to the
primary medicament container part and this is cumbersome from the mechanical point of
view and the workability point of view.
JP-A-2003-62038 describes a case where since the secondary
medicament-housing container part becomes relatively large when a flat bag formed of a
sheet is used, a bag-shaped secondary medicament-housing container part is housed in a
primary medicament container so as to suppress increase in the size of the entire
medicament. In order to accommodate a secondary medicament-housing container part
in a primary medicament container, foreign matters attached to the surface of the
secondary medicament-housing container part must be thoroughly removed and the
secondary medicament-housing container must be inserted by opening the primary
medicament container in a clean environment, but this is very cumbersome from the
mechanical point of view and the workability point of view.
Furthermore, JP-A-2000-5275 discloses a medical container in which a
container for housing a relatively small-content secondary medicament is formed to
intrude into a suspension hole. The object of this invention is to greatly reduce a danger
of forgetting the operation of adding a small-content secondary medicament by passing
the secondary medicament through the partition between the secondary
medicament-housing chamber and the primary medicament-housing chamber. More
specifically, on hanging a transfusion container, a notice is directed to the secondary
medicament due to disturbance of the secondary medicament chamber intruded into the
suspension hole, and a failure of forgetting to mix the medicament is thereby prevented.
It is stated that for the purpose of distinguishing whether the secondary medicament is

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mixed or not. the material constituting the small-content secondary medicament chamber
preferably has flexibility.
It is also stated that when the secondary medicament is not mixed and remains in
the secondary medicament chamber, the mixing medicament chamber is inflated and
therefore, this can be easily viewed from outside. As understood from these, in the
invention described in JP-A-2000-5275, the material constituting the secondary
medicament-housing chamber is substantially soft and the secondary
medicament-housing chamber is inflated when housing a secondary medicament but is
deflated when the secondary medicament is mixed with the primary medicament. Such
a secondary medicament-housing container part comprising a substantially soft material
and being deflated in the state of not housing a secondary medicament requires a large
area for housing a small-content secondary medicament, and a very large medical
container results.
As described above, the invention of JP-A-2002-165864 has a problem that
when a container for housing a small-content secondary medicament is produced from a
planar container capable of weak sealing, a container with a large area is necessary and
the size of the entire medicament becomes large. In the invention of
JP-A-2003-159309, when an injection molded member is used for the secondary
medicament-housing container part, opening to the primary medicament container can be
attained by fracturing a part of the injection molded member at the mixing on use.
Therefore, the injection molded member must be designed and produced not to generate
fine pieces, particles or the like at the fracturing and the management of production is
very severe.
In the invention of JP-A-2003-62038, in order to accommodate a secondary
medicament-housing container part in a primary medicament container, foreign matters

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attached to the surface of the secondary medicament-housing container part must be
thoroughly removed and an operation of opening the primary medicament container in a
clean environment and placing and fixing the secondary medicament-housing container
part therein must be performed. Such a process requires a mechanically complicated
apparatus and moreover, the apparatus must be installed and operated in a clean
environment. Furthermore, there is a problem that the control for preventing foreign
matters from mingling is very cumbersome.
In the invention of JP-A-2000-5275, if the container for housing a small-content
secondary medicament is produced in a shape capable of weak sealing, a container with a
large area is necessary and the entire medicament size becomes large. In this patent
publication, it is also disclosed to use the injection molded member for the partition wall
dividing a mixing medicament container and a primary medicament container or for the
mixing medicament container itself, but in such a case, there arises a problem that the
production process is more cumbersome and difficult than in the case of using the
peelable partitioning means and the produced container becomes expensive.
The present invention has been made under these circumstances and an object of
the present invention is to provide a relatively compact medical liquid container which is
free from sealing failure in the seal portion at the peripheral edge of the liquid
medicament-housing chamber and also free from deterioration of a medicament housed
in a small amount and ensures good usability as a medical container; and a
preparation-containing medical liquid container.
DISCLOSURE OF THE INVENTION
In order to attain the above-described object, the present invention provides a
medical liquid container having a primary liquid medicament-housing chamber for

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housing a medicament and at least one secondary liquid medicament-housing chamber
for housing a liquid medicament smaller in the amount than the liquid medicament
housed in the primary liquid medicament-housing chamber, which is connected with the
primary liquid medicament-housing chamber, an inside of the primary liquid
medicament-housing chamber and an inside of the secondary liquid medicament-housing
chamber being communicatably divided, wherein the secondary liquid
medicament-housing chamber has a bulge part bulged such that the internal
medicament-housing space before housing a medicament is larger than the volume of the
housed medicament.
In the medical liquid container, it is preferable that the secondary liquid
medicament-housing chamber be liquidtightly sealed, and communicatably divided from
the primary liquid medicament-housing chamber. In this case, it is also preferable that
the liquidtight seal is formed at the outside of the primary liquid medicament-housing
chamber.
In the medical liquid container, it is preferable that the primary liquid
medicament-housing chamber be made of a flexible sheet material.
The bulge part may comprise two sheet members and a separation member
separating those two sheet members from each other to form a space and being housed in
the secondary liquid medicament-housing chamber. The bulge part may be formed by
cold stretching or heat stretching of a sheet member. Also, the secondary liquid
medicament-housing chamber may be a blow-molded article.
The primary liquid medicament-housing chamber may comprise a plurality of
housing chambers divided by a peelable liquidtight seal. A preparation-containing
medical liquid container housing a medicament in each of the primary liquid
medicament-housing chamber and the secondary liquid medicament-housing chamber of

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the above-described medical liquid container is provided. The secondary liquid
medicament-housing chamber may be a preparation-containing secondary liquid
medicament-housing chamber produced by a method of continuously performing
formation of a chamber by blow molding, housing of a medicament and sealing of the
chamber.
In the preparation-containing medical liquid container, it is preferable that a
medicament containing any one or more of a sugar, an electrolyte, and an amino acid be
housed in the primary liquid medicament-housing chamber. Simultaneously, it is
preferably that a medicament containing any one or more of a water-soluble vitamin, a
fat-soluble vitamin and a trace element be housed in the secondary liquid
medicament-housing chamber.
According to the present invention, a bulge part larger, before housing a
medicament, than the volume of a medicament housed in the internal
medicament-housing space is previously formed in the secondary liquid
medicament-housing chamber, whereby the medicament is prevented from spreading like
a film between sheets over a wide area but housed with a thickness in the bulge part.
By feeding a small-content medicament into this bulge part, contact of the medicament
itself with the heat-seal part and occurrence of sealing failure can be prevented at the
time of sealing the secondary liquid medicament-housing chamber by heat sealing.
Furthermore, the medicament is also prevented from deterioration due to contact with the
heat seal and a medicament in a good state is housed in the bulge part. In addition, the
area of the secondary liquid medicament-housing container can be made small and a
medical liquid container with compactness in its entirety and good usability can be
obtained.

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BRIEF DESCRIPTION OF THE DRAWINGS
Fig. 1 is a perspective view showing an embodiment of the medical liquid
container of the present invention.
Fig. 2 is a principal part cross-sectional view of the medical liquid container
shown in Fig. 1.
Fig. 3 is a principal part cross-sectional view of another embodiment of the
medical liquid container of the present invention.
Fig. 4A is a principal part cross-sectional view of another embodiment of the
medical liquid container of the present invention, and Fig. 4B is a view showing the
medical liquid container show in Fig. 4A when the primary liquid medicament-housing
chamber is pressed.
Fig. 5 is an explanatory view showing a mode of operation of the
preparation-containing medical liquid container of the present invention.
Fig. 6 is an explanatory view showing a mode of operation of the
preparation-containing medical liquid container of the present invention.
Fig. 7 is a perspective view showing another embodiment of the medical liquid
container of the present invention.
Fig. 8 is a perspective view showing another embodiment of the medical liquid
container of the present invention.
Fig. 9 is a perspective view showing another embodiment of the medical liquid
container of the present invention.
BEST MODE FOR CARRYING OUT THE INVENTION
The present invention is described in detail below by referring to the drawings.
Fig. 1 is an outer appearance perspective view showing one example of the

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medical liquid container of the present invention. The medical liquid container 10
comprises a primary liquid medicament-housing chamber 11 for housing a first liquid
medicament and a secondary liquid medicament-housing chamber 12 for housing a
second liquid medicament smaller in the amount than the first liquid medicament housed
in the primary liquid medicament-housing chamber 11, which is connected with the
primary liquid medicament-housing chamber 11.
In the primary liquid medicament-housing chamber 11, almost the entire
circumference of the peripheral edge part forms an unseparably sealed strong seal part 13
and the entirety is formed from a sheet-like member having flexibility, such as synthetic
resin film. The resin used for the synthetic resin film is not particularly limited as long
as it is a resin used in the field of medical container. Specific examples thereof include
a polyolefin resin, a polyamide resin, a polyester resin, a poly(meth)acrylate, a polyvinyl
chloride, a polyvinylidene chloride, a polyethersulfone and an ethylene-vinyl alcohol
copolymer. Among these, a polyolefin resin is preferred because this is inexpensive and
excellent in the transparency, flexibility and hygiene.
Examples of the polyolefin resin include a polyethylene-based resin such as
high-density polyethylene, medium-density polyethylene, high-pressure low-density
polyethylene, linear low-density polyethylene and ethylene-vinyl acetate copolymer, an
olefin-based elastomer such as ethylene-a-olefin random copolymer, a
polypropylene-based resin such as polypropylene, ethylene-propylene random copolymer
and a-olefin-propylene random copolymer, a cyclic polyolefin resin, and a mixture
thereof. Such a resin may be partially crosslinked for the purpose of enhancing heat
resistance or the like.
Also, this synthetic resin film may be a single-layer film comprising one of
those resins or two or more thereof in blend or may be a multilayer film comprising two

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or more layers. Such a synthetic resin film may have a thickness of 50 to 1,000 μm,
preferably on the order of 100 to 500 μm. The synthetic resin film may be either a cast
film produced by T-die casting or a blown film produced by blown film fabrication.
A discharge port 18 is formed at one end of the primary liquid
medicament-housing chamber 11. This discharge port 18 is a liquid outlet for taking
out a mixed liquid medicament resulting from mixing of the first liquid medicament and
the second liquid medicament and by connecting thereto exclusive discharge means such
as adapter or needle, the mixed liquid medicament is taken out from the medical liquid
container 10. The discharge port is sometimes used as an injection port for mixing and
injecting another medicament to the mixed liquid medicament. In addition to the
discharge port 18, one injection port or two ore more injection ports may be separately
joined to the one end, the other end or the like of the primary liquid medicament-housing
chamber. The discharge port 18 may be joined to the secondary liquid
medicament-housing chamber.
Fig. 2 is a principal part cross-sectional view showing a part of the primary
liquid medicament-housing chamber 11, and a secondary liquid medicament-housing
chamber 12. The secondary liquid medicament-housing chamber 12 is connected to the
primary liquid medicament-housing chamber 11 at the opposite side to the side in which
the discharge portion 18 is formed. In this embodiment, the primary liquid
medicament-housing chamber 11 and the secondary liquid medicament-housing chamber
12 are formed separately, and they are overlapped at a connection part 14 and adhered
such that they cannot peel each other. The secondary liquid medicament-housing
chamber 12 has a bulge part 15 bulged such that the internal medicament-housing space
before housing a secondary medicament is larger than the volume of the housed second
medicament. The secondary liquid medicament-housing chamber 12 is formed

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stereoscopically.
The bulge part 15 may be formed stereoscopically, for example, by cold
stretching or heat stretching of a sheet member or by blow molding using a die. The
secondary liquid medicament-housing chamber 12 having such a bulge part 15 can be
formed of various synthetic resins. Specific examples thereof include a polyolefin
resin, a polyamide resin, a polyester resin, a poly(meth)acrylate, a polyvinyl chloride, a
polyvinylidene chloride, a polyethersulfone and an ethylene-vinyl alcohol copolymer.
Among these, a polyolefin resin is preferred because this resin is inexpensive and
excellent in the transparency, flexibility and hygiene.
Examples of the polyolefin resin include a polyethylene-based resin such as
high-density polyethylene, medium-density polyethylene, high-pressure low-density
polyethylene, linear low-density polyethylene and ethylene-vinyl acetate copolymer, an
olefin-based elastomer such as ethylene-a-olefin random copolymer, a
polypropylene-based resin such as polypropylene, ethylene-propylene random copolymer
and a-olefin-propylene random copolymer, a cyclic polyolefin resin, and a mixture
thereof. Such a resin may be partially crosslinked for the purpose of enhancing heat
resistance or the like. Furthermore, the secondary liquid medicament-housing chamber
having a bulge part 15 may have a single-layer or multilayer structure comprising one or
more resin selected from those various synthetic resins.
Particularly, in the case of a medicament which adsorbs to a polyethylene resin
or a polypropylene resin generally employed for medical usage, such as fat-soluble
vitamin compound, the secondary liquid medicament-housing chamber preferably takes a
multilayer structure using a cyclic polyolefin for the innermost layer coming into contact
with the medicament.
In the case where the secondary liquid medicament-housing chamber houses a

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medicament such as antibiotic which deteriorates due to oxygen or the like in the outer
air, the secondary liquid medicament-housing chamber preferably takes a multilayer
structure comprising a resin having a gas barrier property against oxygen or the like, such
as ethylene-vinyl alcohol copolymer, and another resin. Furthermore, in order to
elevate the adhesive strength between respective resin layers in the multilayer structure, a
resin having compatibility in common may be mixed in one or both of the resins
constituting the adjacent layers, or a layer comprising a resin having compatibility in
common, for example, an adhesive resin such as ethylene-vinyl acetate copolymer, may
be added between those layers.
In the case where a medicament which deteriorates due to light (e.g., ultraviolet
ray), such as vitamin compound, is housed as the secondary liquid medicament, a layer
of shielding light in the wavelength region harmful to the medicament may be added.
For example, in order to shield ultraviolet ray, an iron oxide-containing polyolefin resin
may be used for the outer layer of the secondary liquid medicament-housing chamber in
a multilayer structure.
When the secondary liquid medicament-housing chamber has a multilayer
structure, the multilayer structure may be formed by co-extrusion molding of multiple
layers. Alternatively, single-layer or multilayer materials may be bonded by heat
lamination, dry lamination or the like to obtain an objective multilayer structure.
The second medicament (secondary medicament) housed in the secondary liquid
medicament-housing chamber 12 is mixed with the first medicament (primary
medicament) housed in the primary liquid medicament-housing chamber 11 on use
immediately before administering the medicament to a patient or the like. In order to
facilitate the mixing on use, it is preferable that a liquidtight seal 16 allowing for
communication between the inside of the secondary liquid medicament-housing chamber

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12 and the inside of the primary liquid medicament-housing chamber 11 upon pressing
the bulge part 15 of the secondary liquid medicament-housing chamber 12 or pressing
the primary liquid medicament-housing chamber 11, be formed.
The liquidtight seal 16 is formed such that it communicatably divides the inside
of the primary liquid medicament-housing chamber 11 and the inside of the secondary
liquid medicament-housing chamber 12. The configuration of the liquidtight seal 16 is
not limited, but it is preferable that the liquidtight seal 16 be formed so as to be peelable
by heat-seal joining. In addition, as shown in Fig. 2, it is also preferable that the inside
of the primary liquid medicament-housing chamber 11 and the inside of the secondary
liquid medicament-housing chamber 12 be communicably divided by liquidtight seal 16
joining the secondary liquid medicament-housing chamber 12. When the medical liquid
container has such structure, it is possible to house the second medicament in the
secondary liquid medicament-housing chamber 12, and liquidtight seal 16 the secondary
liquid medicament-housing chamber 12, and then connect the secondary liquid
medicament-housing chamber 12 with the primary liquid medicament-housing chamber
11. Since the second medicament in the secondary liquid medicament-housing chamber
12 is not contacted with ambient air continuously, the medical liquid container having
such a structure is preferable from the aspect of good hygiene.
Specific embodiments of the position of the liquidtight seal 16 in the secondary
liquid medicament-housing chamber 12 include an inside of the primary liquid
medicament-housing chamber 11 as shown in Figs. 3 and 4A, in addition to an outside of
the primary liquid medicament-housing chamber 11 as shown in Figure 2. In the
embodiment shown in Fig. 3, the liquidtight seal 16 is formed so as to correspond to the
connection part 14 in which the primary liquid medicament-housing chamber 11 and the
secondary liquid medicament-housing chamber 12 are adhered. In the embodiment

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shown in Fig. 4A, the liquidtight seal 16 is formed at portion other than the connection
part 14 in which the primary liquid medicament-housing chamber 11 and the secondary
liquid medicament-housing chamber 12 are adhered. In this embodiment, the
liquidtight seal 16 is formed at the edge portion of the secondary liquid
medicament-housing chamber 12.
In any embodiments shown in Figs. 2, 3, and 4A, it is possible to connect the
primary liquid medicament-housing chamber 11 and the secondary liquid
medicament-housing chamber 12 without subjecting the second medicament in the
secondary liquid medicament-housing chamber 12 to ambient air, and these embodiments
are excellent in hygiene. However, from the viewpoint of ease of peeling of the
liquidtight seal 16 in using the medical liquid container, the embodiments shown in Figs.
2 and 3 are preferable. Specifically, in the embodiments shown in Figs. 2 and 3, it is
possible to easily peel the liquidtight seal 16 by arbitrarily select and press the primary
liquid medicament-housing chamber 11 or the secondary liquid medicament-housing
chamber 12.
In contrast, in the embodiment shown in Fig. 4A, when the primary liquid
medicament-housing chamber 11 is pressed, as shown in Fig. 4B, sufficient pressure to
peel is not applied to the liquidtight seal 16. Due to this, it is necessary to press the
secondary liquid medicament-housing chamber 12 to peel the liquidtight seal 16.
Therefore, from the viewpoint of ease of peeling of liquidtight seal 16 in using
the medical liquid container, the embodiments shown in Figs. 2 and 3 are preferable.
In addition, from the viewpoint of ease of production of the medical liquid
container, the embodiment shown in Fig. 2 is more preferable than the embodiments
shown in Fig 3. Specifically, in the embodiment shown in Fig. 2. the liquidtight seal 16
is formed so as not to overlap the connection part 14 in which the primary liquid

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medicament-housing chamber 11 and the secondary liquid medicament-housing chamber
12 are adhered. There is technical difficulty to form the connection part 14 and the
liquidtight seal 16 at the same position, which have different heat seal strengths. In
addition, when the connection part 14 and the liquidtight seal 16, which have different
heat seal strengths, are formed at the same position, thermal damage is applied to the
same position at several time. However, in the embodiment in Fig. 2, since the
liquidtight seal 16 of the secondary liquid medicament-housing chamber 12 is formed so
as not to overlap the connection portion 14, these problems do not generate. Therefore,
it is preferable that the liquidtight seal 16 of the secondary liquid medicament-housing
chamber 12 be formed so as not to overlap the connection portion 14, and more
preferable that the liquidtight seal 16 be formed at the outside the primary liquid
medicament-housing chamber 11.
The liquidtight seal which can be peeled upon application of a pressure to allow
for communication is not particularly limited in its formation method but may be formed,
for example, by the method described in JP-A-2004-000476 where melt-bonding is
performed such that the area occupied by the strong melt-bonding part in the
melt-bonding part becomes less than 25%. Alternatively, the partition wall-forming
portion of a blow molding die may be constituted to make the distance between opposing
faces of the die to be broader than the distance undergoing complete melt-bonding or the
distance completely not undergoing melt-bonding, so that the bonding can be suppressed
to such an extent of allowing for communication while having satisfactory
liquidtightness. Also, similarly to the above-described seal shape, the liquidtight seal
can be formed by employing a die shape constituted such that the strong melt-bonding
part occupies less than 25%.
The connection part 14 unseparably connecting the secondary liquid

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medicament-housing chamber 12 and the primary liquid medicament-housing chamber
11 can be formed by a technique such as heat:seal joining, joining through a cylindrical
member, or joining through a partitioning member described in JP-A-2001- 87350.
Particularly, in the case of inserting the end part of the secondary liquid
medicament-housing chamber 12 into the primary liquid medicament-housing chamber
11 and heat-sealing it to effect joining, when the sheet material constituting each chamber
is made to have a multilayer structure and the resin of each layer is selected so that the
sealing temperature at the joining of the outer face of the secondary liquid
medicament-housing chamber 12 with the inner face of the primary liquid
medicament-housing chamber 11 can be set to be lower than the temperature at the
melt-bonding of inner faces of the secondary liquid medicament-housing chamber 12
with each other, the secondary liquid medicameni-housing chamber 12 and the primary
liquid medicament-housing chamber 11 can be joined by a simple and easy sealing
process.
Inversely, in the case where the outer face of the primary liquid
medicament-housing chamber 11 and the inner face of the secondary liquid
medicament-housing chamber 12 are joined by heat sealing, when the sheet material
constituting each chamber is made to have a multilayer structure and the resin of each
layer is selected so that the sealing temperature at the joining of the outer face of the
primary liquid medicament-housing chamber 11 with the inner face of the secondary
liquid medicament-housing chamber 12 can be set to be lower than the temperature at the
melt-bonding of inner faces of the primary liquid medicament-housing chamber 11 with
each other, the secondary liquid medicament-housing chamber 12 and the primary liquid
medicament-housing chamber 11 can also be joined by a simple and easy sealing process.
In the examples of the present invention described by referring to Figs. 2 to 4, a

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liquidtight seal 16 capable of being peeled to allow for communication is applied only to
the secondary liquid medicament-housing chamber 12, but the liquidtight seal may be
similarly applied to the primary liquid medicament-housing chamber 11 or may be
applied both to the secondary liquid medicament-housing chamber 12 and the primary
liquid medicament-housing chamber 11.
The mode of operation of the preparation-containing medical liquid container
obtained by housing medicaments in a medical liquid container having the
above-described constitution is described by referring to Figs. 5 and 6. As shown in
Fig. 5, the preparation-containing medical liquid container 10 is housing, for example,
approximately from 100 mL to 5 L of a medicament and a first medicament (primary
medicament) 22 is housed in the primary liquid medicament-housing chamber 11,
whereas a second medicament (secondary medicament) 23 with the content being equal
to or smaller than the first medicament 22 is housed in the secondary liquid
medicament-housing chamber 12. The secondary liquid medicament-housing chamber
22 is not particularly limited in its capacity but when the medicament content is small,
the capacity is specifically 100 mLor less or depending on the case, as small as 10 mLor
less.
At this time, a bulge part 15 having a volume larger than the second medicament
23 is previously formed in the secondary liquid medicament-housing chamber 12,
whereby the medicament is prevented from spreading like a film between sheets over a
wide area as compared with the case of feeding a small amount of a medicament into a
secondary liquid medicament-housing chamber constituted by two flat sheet materials
and can be housed with a thickness in the bulge part 15. By feeding a small amount of
second medicament 23 into such a bulge part 15, contact of the second medicament 23
itself with the heat-seal part and occurrence of sealing failure can be prevented at the

20
time of sealing the secondary liquid medicament-housing chamber 12 by heat sealing.
Furthermore, the second medicament is also prevented from deterioration due to contact
with the heat seal and a second medicament 23 in a good state is housed in the bulge part
15.
In using such a preparation-containing medical liquid container 10, as shown in
Fig. 6, for example, the bulge part 15 of the secondary liquid medicament-housing
chamber 12 is pressed and crushed, whereby the liquidtight seal 16 is peeled to allow for
communication between the inside of the primary liquid medicament-housing chamber
11 and the inside of the secondary liquid medicament-housing chamber 12. As a result,
the first medicament (primary medicament) 22 housed in the primary liquid
medicament-housing chamber 11 and the second medicament (secondary medicament)
23 housed in the secondary liquid medicament-housing chamber 12 are mixed and a
mixed medicament 25 is formed.
Two or more secondary liquid medicament-housing chambers each having such
a bulge part may be formed for one primary liquid medicament-housing chamber. As
shown in Fig. 7, two secondary liquid medicament-housing chambers 33 and 34 are
formed on one end side of the primary liquid medicament-housing chamber 32 of the
medical liquid container 31. In these secondary liquid medicament-housing chambers
33 and 34, bulge parts 35 and 36 for housing a small amount of a liquid medicament
while keeping the quality are formed, respectively.
In this way, by connecting two or more secondary liquid medicament-housing
chambers 33 and 34 for one primary liquid medicament-housing chamber 32, a mixed
liquid medicament in various combinations can be formed on use. Also, two secondary
liquid medicament-housing chambers 33 and 34 shown in Fig. 7 are preferably molded
and integrated at the same time. The integrated multiple secondary liquid

21
medicament-housing chambers 33 and 34 can be joined with the primary liquid
medicament-housing chamber 32 at one time and since the number of joining operations
does not increase even if the number of secondary liquid medicament-housing chambers
33 is increased, the production of the medical liquid container is advantageously
facilitated.
The preparation-containing medical liquid container described above may also
employ a system such that the primary liquid medicament-housing chamber is pressed on
use to apply a pressure to the primary liquid medicament and by the effect of this
pressure, the liquidtight seal, which divides the primary liquid medicament-housing
chamber and the secondary liquid medicament-housing chamber, is peeled to mix the
primary liquid medicament and the secondary liquid medicament on use. Particularly,
in the case where two or more secondary liquid medicament-housing chambers are
joined, it is more easy and simple to press the primary liquid medicament-housing
chamber and peel liquidtight seals all at once.
Fig. 8 is another embodiment in which the constitution of the bulge part of the
secondary liquid medicament-housing chamber is changed. In the secondary liquid
medicament-housing chamber 43 connected to the primary liquid medicament-housing
chamber 42 of the medical liquid container 41 of this embodiment, the bulge part 46 is
formed by housing a separation member 45 between two sheet members 44.
This separation member 45 is not limited in its shape and as long as two sheet
members 44 can be separated from each other to form a fixed space before housing a
medicament, the separation member may have, for example, a spherical, columnar, cubic
or rectangular parallelepiped shape other than the cylindrical shape shown in Fig. 8. As
for the two sheet members, one sheet member may be folded or a blown film may be
used. The separation member 45 may be formed of, for example, a polyolefin resin

22
such as polyethylene resin, polypropylene resin and cyclic polyolefin resin, a polyamide
resin, a polyester resin, a poly(meth)acrylate, a polyvinyl chloride, a polyvinylidene
chloride, a polyethersulfone, an ethylene-vinyl alcohol copolymer or a blend thereof.
Furthermore, in the medical liquid container, the primary liquid
medicament-housing chamber may be divided into a plurality of chambers by
communicatable liquidtight seal. For example, as shown in Fig. 9, the medical liquid
container 58 may comprise first and second primary liquid medicament-housing
chambers 52 and 53, of which the insides are divided by a peelable liquidtight seal 51,
and three secondary liquid medicament-housing chambers 54, 55 and 56 connected to the
second primary liquid medicament-housing chamber 53 by the connection part 59. In
this medical liquid container 58, two kinds of primary liquid medicaments and three
kinds of secondary liquid medicaments can be mixed on use. Also, an injection port for
co-injecting a medicament may be fixed to the second primary liquid
medicament-housing chamber 53.
In the medical liquid container 58 in this embodiment, only the secondary liquid
medicament-housing chambers 54, 55 and 56 are provided with the liquidtight seals 57a,
57b, and 57c, and these liquidtight seals 57a, 57b, and 57c are positioned at the outside of
the second primary liquid medicament-housing chamber 53. Due to this structure, it is
possible to seal the secondary liquid medicament-housing chambers 54, 55 and 56 with
the liquidtight seals 57a, 57b, and 57c, and then connect the secondary liquid
medicament-housing chambers 54, 55 and 56 with second primary liquid
medicament-housing chamber 53, and this is excellent in hygiene. In addition, it is
possible to peel simultaneously the liquidtight seal 51, which divides the inside of the
first primary liquid medicament-housing chamber 52 and the inside of the second
primary liquid medicament-housing chamber 53, and all of the liquid seals 57a, 57b, and

23
57c, which divide the inside of the second primary liquid medicament-housing chamber
53 and the insides of the secondary liquid medicament-housing chambers 54,55 and 56
by only one operation of pressing the second primary liquid medicament-housing
chamber 53 connected to the secondary liquid medicament-housing chambers 54, 55 and
56. According to such a medical liquid container 58, it is not necessary to complicated
operations such as peeling all of the liquid seals 51, 57a, 57b, and 57c in turn, and
preparation of a medicament is easy, and it is possible to prevent a generation of a trouble
such as a failure of forgetting to peel one of three liquidtight seals 57a, 57b, and 57c.
The medical liquid container of the present invention can be used, for example,
as a container for housing a kit preparation for intravenous hyperalimentation or a kit
preparation for peripheral parenteral nutrition, which are used in the intravenous
hyperalimentation method, or for housing a component nutrition used in the enteral
nutrition method. The preparation-containing medical liquid container of the present
invention is the medical liquid container of the present invention in which a medicament
is housed in each of the primary liquid medicament-housing chamber and the secondary
liquid medicament-housing chamber. The primary medicament housed in the primary
liquid medicament-housing chamber is not particularly limited, but examples thereof
include a solution such as distilled water, an electrolyte infusion such as physiological
saline, a saccharides infusion such as glucose solution, an amino acid infusion such as
amino acid preparation, and a fat infusion such as fat emulsion.
In the case where the primary liquid medicament-housing chamber comprises a
plurality of chambers, the primary medicament is not particularly limited, but examples
thereof include a nutrient infusion containing any one or more of sugar, electrolyte,
amino acid, fat emulsion and the like, a blood substitute infusion comprising a
combination of various electrolytes, and a dialysis fluid comprising a combination of

24
sugar and electrolyte. The secondary medicament housed in the secondary liquid
medicament-housing chamber is also not particularly limited, but examples thereof
include vitamins (e.g., water-soluble vitamin, fat-soluble vitamin), trace metal (e.g.,
copper, iron, manganese, zinc), iodine, calcium chloride for correction, insulin, antibiotic,
anticancer drug, anti-peptic ulcer agent, hepatic disorder remedy, cardiac, analgesic,
antipyretic analgesic, anesthetic, fat emulsion, hypotensive agent, vasodilator, hormone
preparation and heparin. The medicament housed is not limited to a liquid medicament
but may be a solid or powder medicament.
Particularly, in the case of housing a liquid medicament in the secondary liquid
medicament-housing chamber, a preparation-containing secondary liquid
medicament-housing chamber produced by a method of continuously performing
formation of a chamber by blow molding, housing of a medicament and sealing of the
chamber is preferably used, because the medicament can be sterilely housed in the
secondary liquid medicament-housing chamber without opening the secondary liquid
medicament-housing chamber.
Examples of the kit preparation for intravenous hyperalimentation used in the
intravenous hyperalimentation method, which is housed in the preparation-containing
medical liquid container of the present invention, include a high calorie infusion used as
an initiating solution or a maintenance solution. In a preferred embodiment of the high
calorie infusion, a medicament containing any one or more of sugar, electrolyte and
amino acid is housed in the primary liquid medicament-housing chamber, and a
medicament containing any one or more of water-soluble vitamin, fat-soluble vitamin
and trace element is housed in the secondary liquid medicament-housing chamber.
INDUSTRIAL APPLICABILITY

25
According to the present invention, a bulge part larger, before housing a
medicament, than the volume of a medicament housed in the internal
medicament-housing space is previously formed in the secondary liquid
medicament-housing chamber, whereby the medicament is prevented from spreading like
a film between sheets over a wide area but housed with a thickness in the bulge part.
By feeding a small amount of medicament into this bulge part, contact of the medicament
itself with the heat-seal part and occurrence of sealing failure can be prevented at the
time of sealing the secondary liquid medicament-housing chamber by heat sealing.
Furthermore, the medicament is also prevented from deterioration due to contact with the
heat seal and a medicament in a good state is housed in the bulge part. In addition, the
area of the secondary liquid medicament-housing container can be made small and a
medical liquid container with compactness in its entirety and good usability can be
obtained.

26
CLAIMS
1. A medical liquid container having a primary liquid medicament-housing
chamber for housing a medicament and at least one secondary liquid
medicament-housing chamber for housing a liquid medicament smaller in the amount
than the liquid medicament housed in the primary liquid medicament-housing chamber,
which is connected to the primary liquid medicament-housing chamber, an inside of the
primary liquid medicament-housing chamber and an inside of the secondary liquid
medicament-housing chamber being communicatably divided, wherein said secondary
liquid medicament-housing chamber has a bulge part bulged such that the internal
medicament-housing space before housing a medicament is larger than the volume of the
housed medicament.
2. The medical liquid container as claimed in claim 1, wherein the secondary liquid
medicament-housing chamber is liquidtightly sealed, and communicatably divided from
the primary liquid medicament-housing chamber.
3. The medical liquid container as claimed in claim 2, wherein the liquidtight seal
is formed at the outside of the primary liquid medicament-housing chamber.
4. The medical liquid container as claimed in any one of claims 1 to 3, wherein the
primary liquid medicament-housing chamber is formed by a flexible sheet material.
5. The medical liquid container as claimed in any one of claims 1 to 3, wherein
said bulge part comprises two sheet members and a separation member separating said
two sheet members from each other to form a space and being housed in said secondary

27
liquid medicament-housing chamber.
6. The medical liquid container as claimed in any one of claims 1 to 3, wherein
said bulge part is formed by cold stretching or heat stretching of a sheet member.
7. The medical liquid container as claimed in any one of claims 1 to 3, wherein
said secondary liquid medicament-housing chamber is a blow-molded article.
8. The medical liquid container as claimed in any one of claims 1 to 3, wherein
said primary liquid medicament-housing chamber comprises a plurality of housing
chambers divided by a separable liquidtight seal.
9. A preparation-containing medical liquid container housing a medicament in each
of said primary liquid medicament-housing chamber and said secondary liquid
medicament-housing chamber of the medical liquid container claimed in any one of
claims 1 to 3.
10. The preparation-containing medical liquid container as claimed in claim 9,
wherein said secondary liquid medicament-housing chamber comprises a
preparation-containing secondary liquid medicament-housing chamber produced by a
method of continuously performing formation of a chamber by blow molding, housing of
a medicament and sealing of the chamber.
11. The preparation-containing medical liquid container as claimed in claim 9,
wherein a medicament containing any one or more of a sugar, an electrolyte and an

28
amino acid is housed in the primary liquid medicament-housing chamber and a
medicament containing any one or more of a water-soluble vitamin, a fat-soluble vitamin
and a trace element is housed in the secondary liquid medicament-housing chamber.
12. The preparation-containing medical liquid container as claimed in claim 9,
wherein a medicament containing at least one of a water-soluble vitamin, a fat-soluble
vitamin, and a trace element is housed in the secondary liquid medicament-housing
chamber.

To provide a medical liquid container which is free from sealing failure in the seal portion at the peripheral edge of the liquid medicament-housing chamber and also free from deterioration of a medicament housed in a small amount; and a preparation-containing medical liquid container. A secondary liquid medicament-housing chamber 12 is connected to one end of a primary liquid medicament-housing chamber 11. This secondary liquid medicament-housing chamber 12 is unseparably fixed to the primary liquid medicament-housing, chamber 11 at a connection part 14. The secondary liquid medicament-housing chamber 12 has a bulge part 15 bulged such that the internal medicament-housing space before housing a second medicament is larger than the volume of the housed second medicament.


Documents:

01838-kolnp-2007-abstract.pdf

01838-kolnp-2007-assignment.pdf

01838-kolnp-2007-claims.pdf

01838-kolnp-2007-correspondence others 1.1.pdf

01838-kolnp-2007-correspondence others 1.2.pdf

01838-kolnp-2007-correspondence others 1.3.pdf

01838-kolnp-2007-correspondence others.pdf

01838-kolnp-2007-description complete.pdf

01838-kolnp-2007-drawings.pdf

01838-kolnp-2007-form 1.pdf

01838-kolnp-2007-form 18.pdf

01838-kolnp-2007-form 3 1.1.pdf

01838-kolnp-2007-form 3.pdf

01838-kolnp-2007-form 5.pdf

01838-kolnp-2007-gpa.pdf

01838-kolnp-2007-international publication.pdf

01838-kolnp-2007-international search report.pdf

01838-kolnp-2007-pct request form.pdf

01838-kolnp-2007-priority document.pdf

1838-KOLNP-2007-(27-04-2012)-ABSTRACT.pdf

1838-KOLNP-2007-(27-04-2012)-AMANDED CLAIMS.pdf

1838-KOLNP-2007-(27-04-2012)-AMANDED PAGES OF SPECIFICATION.pdf

1838-KOLNP-2007-(27-04-2012)-DESCRIPTION (COMPLETE).pdf

1838-KOLNP-2007-(27-04-2012)-DRAWINGS.pdf

1838-KOLNP-2007-(27-04-2012)-ENGLISH TRANSLATION.pdf

1838-KOLNP-2007-(27-04-2012)-EXAMINATION REPORT REPLY RECEIVED.pdf

1838-KOLNP-2007-(27-04-2012)-FORM-1.pdf

1838-KOLNP-2007-(27-04-2012)-FORM-2.pdf

1838-KOLNP-2007-(27-04-2012)-FORM-3.pdf

1838-KOLNP-2007-(27-04-2012)-FORM-5.pdf

1838-KOLNP-2007-(27-04-2012)-OTHERS.pdf

1838-KOLNP-2007-(27-04-2012)-PETITION UNDER RULE 137.pdf

1838-KOLNP-2007-ASSIGNMENT.pdf

1838-KOLNP-2007-CORRESPONDENCE 1.1.pdf

1838-KOLNP-2007-CORRESPONDENCE.pdf

1838-KOLNP-2007-EXAMINATION REPORT.pdf

1838-KOLNP-2007-FORM 18.pdf

1838-KOLNP-2007-FORM 3.pdf

1838-KOLNP-2007-FORM 5.pdf

1838-KOLNP-2007-GPA.pdf

1838-KOLNP-2007-GRANTED-ABSTRACT.pdf

1838-KOLNP-2007-GRANTED-CLAIMS.pdf

1838-KOLNP-2007-GRANTED-DESCRIPTION (COMPLETE).pdf

1838-KOLNP-2007-GRANTED-DRAWINGS.pdf

1838-KOLNP-2007-GRANTED-FORM 1.pdf

1838-KOLNP-2007-GRANTED-FORM 2.pdf

1838-KOLNP-2007-GRANTED-LETTER PATENT.pdf

1838-KOLNP-2007-GRANTED-SPECIFICATION.pdf

1838-KOLNP-2007-OTHERS.pdf

1838-KOLNP-2007-REPLY TO EXAMINATION REPORT.pdf

1838-KOLNP-2007-TRANSLATED COPY OF PRIORITY DOCUMENT.pdf

abstract-01838-kolnp-2007.jpg


Patent Number 253397
Indian Patent Application Number 1838/KOLNP/2007
PG Journal Number 29/2012
Publication Date 20-Jul-2012
Grant Date 18-Jul-2012
Date of Filing 23-May-2007
Name of Patentee HOSOKAWA YOKO CO., LTD.
Applicant Address 11-5, NIBAN-CHO, CHIYODA-KU, TOKYO
Inventors:
# Inventor's Name Inventor's Address
1 YOSHIKAWA, KATSUYUKI C/O HOSOKAWA YOKO CO., LTD. KAWASAKI RESEARCH CENTER, 5-1, OKAWA-CHO, KAWASAKI-SHI, KANAGAWA-KEN
2 NAKAMURA, MANABU C/O HOSOKAWA YOKO CO., LTD. KAWASAKI RESEARCH CENTER, 5-1, OKAWA-CHO, KAWASAKI-SHI, KANAGAWA-KEN
PCT International Classification Number A61J 1/00
PCT International Application Number PCT/JP2005/022125
PCT International Filing date 2005-11-25
PCT Conventions:
# PCT Application Number Date of Convention Priority Country
1 2004-342695 2004-11-26 Japan
2 2005-327087 2005-11-11 Japan