U.S. patent application number 09/726310 was filed with the patent office on 2001-03-15 for bag for infusion solution and method of manufacturing same.
Invention is credited to Inuzuka, Takeshi, Niwa, Susumu.
Application Number | 20010000042 09/726310 |
Document ID | / |
Family ID | 18323772 |
Filed Date | 2001-03-15 |
United States Patent
Application |
20010000042 |
Kind Code |
A1 |
Inuzuka, Takeshi ; et
al. |
March 15, 2001 |
Bag for infusion solution and method of manufacturing same
Abstract
A bag for an infusion solution has front and back wall portions
each formed of a flexible plastic film and provided with a
plurality of chambers which are filled with one infusion solution
and another infusion solution or medicament, independently. The
chambers are sectioned by a boundary portion having at least one
weak seal portion which is closed by separably bonding inside
surfaces of the plastic films mutually facing at the boundary
portion so that the one infusion solution and the another infusion
solution or medicament in the respective chambers are mixed
together when the weak seal portion is opened. The weak seal
portion is formed by applying a separable coating material, which
provides a reduced bonding strength in a heat sealing process, on
one or both inside surfaces of the plastic films mutually facing at
the boundary portion and then effecting heat sealing process to the
boundary portion. The separable coating material is applied in a
form of a dot-pattern through a printing process.
Inventors: |
Inuzuka, Takeshi; (Tokyo-to,
JP) ; Niwa, Susumu; (Tokyo-to, JP) |
Correspondence
Address: |
YOUNG & THOMPSON
745 SOUTH 23RD STREET 2ND FLOOR
ARLINGTON
VA
22202
|
Family ID: |
18323772 |
Appl. No.: |
09/726310 |
Filed: |
December 1, 2000 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
09726310 |
Dec 1, 2000 |
|
|
|
09086602 |
May 29, 1998 |
|
|
|
Current U.S.
Class: |
604/410 ;
604/416 |
Current CPC
Class: |
B29C 66/71 20130101;
B29C 66/1122 20130101; B29C 66/53263 20130101; B29C 66/929
20130101; B29C 66/71 20130101; B29L 2031/7148 20130101; A61J 1/2093
20130101; B65D 81/3266 20130101; B29C 65/8207 20130101; B29C 66/71
20130101; B29C 66/91411 20130101; B29C 65/76 20130101; B29C 66/4312
20130101; B29C 66/43129 20130101; B29C 66/3452 20130101; B29C
66/919 20130101; B29C 66/71 20130101; B29C 65/18 20130101; A61J
1/2024 20150501; A61M 2207/00 20130101; B29K 2023/12 20130101; A61J
1/10 20130101; B29C 66/71 20130101; B29K 2023/083 20130101; B29K
2023/12 20130101; B29K 2023/0625 20130101; B29K 2027/06 20130101;
B29K 2023/083 20130101 |
Class at
Publication: |
604/410 ;
604/416 |
International
Class: |
A61B 019/00 |
Foreign Application Data
Date |
Code |
Application Number |
Dec 9, 1997 |
JP |
9-339048 |
Claims
What is claimed is:
1. A bag for an infusion solution having front and back wall
portions each formed of a flexible plastic film and provided with a
plurality of chambers which are filled with one infusion solution
and another infusion solution or medicament, independently, said
chambers being sectioned by a boundary portion having at least one
weak seal portion which is closed by separably bonding inside
surfaces of the plastic films mutually facing at the boundary
portion so that the one infusion solution and the another infusion
solution or medicament in the respective chambers are mixed
together when the weak seal portion is opened, wherein said weak
seal portion is formed by applying a separable coating material,
which provides a reduced bonding strength in a heat sealing
process, on one or both inside surfaces of the plastic films
mutually facing at the boundary portion and then effecting heat
sealing process to the boundary portion.
2. A bag for an infusion solution according to claim 1, wherein
said separable coating material is applied in a form of a
dot-pattern.
3. A bag for an infusion solution according to claim 1, wherein one
chamber, which is filled with the infusion solution to be flowed
out into another chamber adjacent to said one chamber by opening
the weak seal portion formed between both the chambers, has a
portion protruded towards said weak seal portion.
4. A bag for an infusion solution according to claim 1, wherein
said boundary portion has a seal portion hard to be opened other
than said weak seal portion.
5. A bag for an infusion solution according to claim 1, wherein
said separable coating material contains silicone release
agents.
6. A method of manufacturing an infusion solution bag which has
front and back wall portions each formed of a flexible plastic film
and which is provided with a plurality of chambers which are filled
with one infusion solution and another infusion solution or
medicament, independently, said chambers being sectioned by a
boundary portion having at least one weak seal portion which is
closed by separably bonding inside surfaces of the plastic films
mutually facing at said boundary portion so that one infusion
solution and the another infusion solution or medicament in the
respective chambers are mixed together, said manufacturing method
comprising the steps of: preparing a flexible plastic film;
applying a separable coating material, which provides a reduced
bonding strength in a heat sealing process, on one or both inside
surfaces of the plastic films in an area forming the weak seal
portion; mating or folding the plastic film so as to form
overlapped two portions forming the front and back wall portions of
the infusion solution bag; effecting heat sealing to an area
forming peripheral edge portions of the infusion solution bag
except portions at which filling ports are formed and effecting
heat sealing to an area forming the boundary portion including the
weak seal portion; filling the one infusion solution and another
infusion solution or medicament into the chambers, independently;
and closing and sealing the filling ports.
7. A manufacturing method according to claim 6, wherein said
separable coating material is applied in a form of dot-pattern and
said dot-pattern is changeable in area ratio thereof for adjusting
separability of the weak seal portion.
8. A manufacturing method according to claim 7, wherein said
separable coating material is applied so as to provide a
dot-pattern on the inside surface of the plastic film through a
printing process.
9. A manufacturing method according to claim 6, wherein said
separable coating material contains silicone release agents.
Description
BACKGROUND OF THE INVENTION
1. The present invention relates to a bag for an infusion solution
particularly having a structure capable of easily mixing, at a time
of use, an infusion solution with another infusion solution or a
medicament other than the infusion solution which have been
preliminarily independently sealed in the bag and also relates to a
method of manufacturing such infusion solution bag.
2. In a case where it is required to prescribe an infusion
solution, it has often be performed to prescribe a solution which
has been prepared by mixing more than two kinds of infusion
solutions or to prescribe a solution which was prepared by mixing a
medicament solution other than the infusion solution with the
infusion solution or dissolving powder of a medicament into the
infusion solution. However, when the solution prepared by mixing
the infusion solution with another infusion solution or medicament
and the mixed solution is preserved, there is a fear such that the
mixed solution may be denatured or discolored. Because of this
reason, it is necessary to preliminarily preserve these solutions
or medicaments as they are and mix them just before the
prescription thereof. For example, with a dialysis solution
utilized for peritoneal dialysis, it is difficult to preserve it
for a long time if a pH thereof be not adjusted to weak acid, but
it gives strong stimulus to a human organism in a case where it has
not the neutral pH. Accordingly, it is necessary to add an alkali
solution to the dialysis solution just before the prescription to
make the pH thereof neutral. For example, in a case where a mixture
solution of glucose infusion solution and amino acid infusion
solution has been left as it is for a long time, Maillard reaction
will be caused and the mixture solution will be discolored. In this
example, it is also necessary to mix these solutions just before
the prescription.
3. In view of the above matters, there has been provided an
infusion solution bag having an inner space which is divided into a
plurality of small chambers or sections into which infusion
solutions, or infusion solution and a medicament other than the
infusion solution, are accommodated respectively. These small
chambers are sectioned by boundary portions which are sealed to be
openable. These infusion solutions or medicament solutions stored
in the respective chambers can be mixed together by opening the
boundary portions just before the use.
4. In one type infusion solution bag of conventional structure, a
shell portion of the infusion solution bag is pinched from the
outer side thereof at several portions by using pinching members to
divide the inner space of the bag into a plurality of small
chambers or sections and various infusion solutions or the like are
accommodated into these divided sections respectively. The pinching
members are removed at the time of prescription to mix these
infusion solutions together.
5. In another type of conventional structure, opposing film
materials constituting both surfaces of an infusion solution bag
are closed, through a heat sealing process, at boundary portions by
which the inner space of the infusion solution bag is divided into
a plurality of small sections. A port forming member is mounted to
a part of each boundary portion, infusion solutions or other
medicament solutions are accommodated in the small sections
respectively, and these solutions are mixed at the infusion
solution prescription time by breaking, for example, bending, the
port forming member.
6. However, according to the conventional structures mentioned
above, it is necessary to preliminarily prepare pinching members or
port forming members and attach them to the infusion solution bag,
resulting in increasing of troublesome working and increasing of
manufacturing cost. Furthermore, it is difficult to strictly
section the respective small chambers in desired shapes, and
moreover, in the case of using the port forming member, since the
thus formed port has a small opened area, it takes much time to
complete the mixing of the infusion solutions accommodated in the
respective sections.
7. Still furthermore, prior art provides a method in which opposing
film materials, constituting both surfaces of an infusion solution
bag, are closed, through a heat sealing process, with a resin film
being interposed therebetween for weakening a sealing strength, at
boundary portions by which the inner space of the infusion solution
bag is divided into a plurality of small sections. Infusion
solutions or other medicament solutions are accommodated into these
small sections or chambers, and when it is required to mix these
solutions in the respective small sections together, the weakly
sealed part of the boundary portion is separated by applying
pressure to the bag body and, then, the solutions in the respective
sections are mixed through the opened boundary portion.
8. However, in this conventional structure, it is also necessary to
prepare a resin film formed of a relatively specific material
having a weakened sealing strength and dispose such resin film to a
desired position of the boundary portion sectioning the respective
small chambers of the bag, also involving troublesome working and
increasing the manufacturing cost. Furthermore, since it is
difficult to arrange the resin film having the weakened strength in
a desired pattern, it is also difficult to section the small
chambers so as to provide desired shapes. Still furthermore, in
this structure, it is necessary to select the material for the
resin film for the adjustment of the sealing strength of the
boundary portion to be separated and to suitably adjust the heating
temperature and pressure at the sealing time. However, it is
extremely difficult to finely adjust the sealing strength of the
resin film by selecting the material therefor, and moreover, in the
heat sealing process, it is difficult to stably control the sealing
strength by adjusting the heating temperature and pressure, which
may result in that the thus manufactured infusion solution bag has
no uniform sealed strength at the boundary portions to be
separated.
SUMMARY OF THE INVENTION
9. An object of the present invention is to substantially eliminate
defects or drawbacks encountered in the prior art described above
and to provide a bag for an infusion solution which has an inner
space divided into a plurality of chambers or sections into which
infusion solutions, or infusion solution and a medicament other
than the infusion solution, are accommodated respectively, and
these chambers are sectioned by weakly sealed portions which are
openable, these chambers having optional shapes as occasion
demands.
10. Another object of the present invention is to provide a method
of effectively manufacturing an infusion solution bag, which has an
inner space divided into a plurality of chambers or sections into
which infusion solutions, or infusion solution and a medicament
other than the infusion solution, are accommodated respectively,
and these chambers are sectioned by weakly sealed portions which
are openable, in a material saving manner with reduced working
labor.
11. These and other objects can be achieved according to the
present invention by providing, in one aspect, a bag for an
infusion solution having front and back wall portions each formed
of a flexible plastic film and provided with a plurality of
chambers which are filled with one infusion solution and another
infusion solution or medicament, independently, the chambers being
sectioned by a boundary portion having at least one weak seal
portion which is closed by separably bonding inside surfaces of the
plastic films mutually facing at the boundary portion so that the
one infusion solution and the another infusion solution or
medicament in the respective chambers are mixed together when the
weak seal portion is opened,
12. wherein the weak seal portion is formed by applying a separable
coating material, which provides a reduced bonding strength in a
heat sealing process, on one or both inside surfaces of the plastic
films mutually facing at the boundary portion and then effecting
heat sealing process to the boundary portion.
13. The separable coating material may contain at least one kind of
silicone release agents. The boundary portion may have a seal
portion hard to be opened other than the weak seal portion.
14. According to the structure of the infusion solution bag of the
present invention, it is possible to form the weak seal portion in
a relatively easy manner such that the separable coating material
is applied on one or both inside surface of the plastic films
forming the front and back wall of the bag respectively. Therefore,
there is no need to provide a pinching member for pinching the
infusion solution bag, a port forming member of a molded product or
a resin film for weakening a sealing strength of the boundary
portion between the chambers, and also no need to mount them on a
predetermined position of the bag, thus forming the infusion
solution bag with no trouble and labor.
15. Furthermore, according to the present invention, since the weak
seal portion is formed by applying the separable coating material
on the inside surface of the plastic film, the weak seal portion
can be easily made into an optional pattern in comparison with the
conventional openable portion provided with the pinching member,
the port forming member, the resin film for weakening the sealing
strength or the like. As a result, the small chambers can be formed
so as to have optional shapes at desired positions, thus performing
the mixing of the inner contents of the respective small chambers
in a correct mixing order.
16. In preferred embodiments, the separable coating material is
applied in a form of a dot-pattern. The sealing strength of the
weak seal portions can be finely controlled by changing an
area-proportion of the dots, thus adequately adjust a separable
performance of the weak seal portions. In addition, according to
the adjustment by using the area-proportion of dots, the stable
sealing strength can be always achieved and all the products have
uniform sealing strength.
17. One chamber, which is filled with the infusion solution to be
flowed out into another chamber adjacent to the one chamber by
opening the weak seal portion formed between both the chambers, may
have a portion protruded towards the weak seal portion. According
to the present invention, the small chambers of the bag can be
formed in an optional shape at a desired position, thus the chamber
can be also formed in the protruded shape. As a result, it comes to
provide the infusion solution bag capable of performing the mixing
of the inner contents of the respective small chambers in a correct
mixing order.
18. In another aspect of the present invention, to achieve the
above mentioned objects, there is also provided a method of
manufacturing an infusion solution bag which has front and back
wall portions each formed of a flexible plastic film and which is
provided with a plurality of chambers which are filled with one
infusion solution and another infusion solution or medicament,
independently, the chambers being sectioned by a boundary portion
having at least one weak seal portion which is closed by separably
bonding inside surfaces of the plastic films mutually facing at
said boundary portion so that one infusion solution and the another
infusion solution or medicament in the respective chambers are
mixed together, the manufacturing method comprising the steps
of:
19. preparing a flexible plastic film;
20. applying a separable coating material, which provides a reduced
bonding strength in a heat sealing process, on one or both inside
surfaces of the plastic films in an area forming the weak seal
portion;
21. mating or folding the plastic film so as to form overlapped two
portions forming the front and back wall portions of the infusion
solution bag;
22. effecting heat sealing to an area forming peripheral edge
portions of the infusion solution bag except portions at which
filling ports are formed and effecting heat sealing to an area
forming the boundary portion including the weak seal portion;
23. filling the one infusion solution and another infusion solution
or medicament into the chambers, independently; and
24. closing and sealing the filling ports.
25. In this aspect, the separable coating material may preferably
be applied in a form of dot-pattern to be changeable in area ratio
thereof for adjusting separability of the weak seal portion. The
separable coating material is applied so as to provide a
dot-pattern on the inner surface of the plastic film through a
printing process. The separable coating material may contain at
least one kind of silicone release agents.
26. According to the characters of the infusion solution bag
manufacturing method of the present invention, the portions of the
boundary portion other than the weak seal portion and the
peripheral edge portion of the bag can be heat-sealed together with
the weak seal portion, so that the infusion solution bag provided
with small chambers can be effectively manufactured. Furthermore,
since the separable coating material can be applied through the
printing process to the weak seal portion at the inside surface of
the plastic film, the area-proportion of dots in the printing
process can be easily adjusted as well as easy formation of the
weak seal portion with optional pattern.
27. The nature and further characteristic features of the present
invention will be made more clear from the following descriptions
made with reference to the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
28. In the accompanying drawings:
29. FIG. 1 is a front view of an infusion solution bag according to
one embodiment of the present invention;
30. FIG. 2 is a front view of an infusion solution bag provided
with one example of a weakly sealed portion;
31. FIG. 3 is a front view of an infusion solution bag provided
with another example of a weakly sealed portion;
32. FIG. 4 is a front view of an infusion solution bag provided
with a further example of a weakly sealed portion;
33. FIG. 5 is a sectional view of a still further example of a
weakly sealed portion of the infusion solution bag;
34. FIGS. 6 to 9 are views for explaining respective steps for a
method of manufacturing an infusion solution bag according to the
present invention, the steps being performed in this order of
figures;
35. FIG. 10 is a view showing 50% area-proportion of dots
(dot-pattern area ratio (%));
36. FIG. 11 is a view showing 30% area-proportion of dots
(dot-pattern area ratio (%));
37. FIG. 12 is a front view of an infusion solution bag having two
chambers according to another embodiment of the present invention
in which mixing order is specified; and
38. FIG. 13 is a front view of an infusion solution bag having
three chambers according to a modification of FIG. 12 of the
present invention in which mixing order is specified.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
39. Preferred embodiments of the present invention will be
described hereunder more in detail with reference to the
accompanying drawings.
40. FIG. 1 is a front view of one embodiment of a bag for an
infusion solution (infusion solution bag 1A) according to the
present invention. The infusion solution bag 1A is one for
artificial dialysis, which is prepared by overlapping two
transparent flexible plastic films 2 (2a, 2b), and peripheral
portions 3 thereof are heat sealed to thereby provide a bag having
sealed four side peripheral portions, called hereinafter as
four-side seal bag or merely seal bag.
41. The infusion solution bag 1A has an inner space which is
divided into two small chambers or sections 7a and 7b by a boundary
portion 4 crossing a shell portion of the bag 1A. A dialysis
solution is accommodated in one 7a of small chambers and an
alkaline solution is accommodated in the other one 7b thereof so as
to make neutral the dialysis solution, these solutions being
independently sealed. The boundary portion 4 is sealed and closed
by heat sealing the opposing plastic films 2a and 2b constituting
front and back wall portions (front and back surface portions) of
the infusion solution bag 1A. The boundary portion 4 has both side
end portions, near the peripheral sides of the bag, at which both
the front and back wall portions 2a and 2b are firmly bonded. The
boundary portion 4 also has a central portion 5 shown by oblique
lines which is weakly bonded so as to be separable as a weakly
sealed portion 5, which may be called herein merely as weak seal
portion 5. As mentioned above, although the boundary portion 4 of
the infusion solution bag 1A shown in FIG. 1 has a separable
portion as the weak seal portion 5 and also has a firmly sealed
portion not separated, the boundary portion 4 may be formed
entirely as the weak seal portion 5 as shown in FIG. 2.
42. The separable weak seal portion 5 can be formed in a manner
that a separable coating material such as silicone separable
materials (release agents) is applied to either one of or both of
inside surfaces of the plastic films 2a and 2b of the front and
back wall portions of the bag 1A and then heat sealing process is
performed to that portion to thereby form the weak seal portion 5.
Accordingly, the weak seal portion 5 is constituted by an area
formed by overlapping an area 6 of the plastic film to which the
coating material is applied and the boundary portion 4 to which the
heat sealing process is applied.
43. With the infusion solution bag 1A shown in FIG. 1, the
separable coating material applied area 6 is set so as to have a
width slightly larger than that of the boundary portion 4 for the
purpose of easily positioning the area 6 and the boundary portion
4. However, it will be easily understood that it is preferable to
set the width of the coating material applied area 6 equal to that
of the boundary portion 4 for preventing the applied coating
material from directly contacting to the infusion solution in the
sectioned chambers of the bag 1A.
44. The separable coating material is applied to the weak seal
portion 5 of the plastic film of the infusion solution bag 1A in a
dot-pattern with a predetermined area-proportion of dots (dot
percentage). According to the present invention, the bonding
strength, i.e. separable performance, of the bonding surface of the
weak seal portion 5 can be controlled by adjusting the
area-proportion of dots of the coating material in a manner such
that when the infusion solution bag 1A is not separated, for
example, in a time of reserving the bag as it is, the sealed
condition can be suitably maintained, whereas when either one of
small chambers 7a or 7b is pressed with a pressure such as that
easily applied by a weight of a user from outside of the bag, the
weak seal portion 5 is easily separated and the infusion solutions
or the like accommodated in both the chambers 7a and 7b are
mixed.
45. Furthermore, it may be possible to partially change the
separable performance of the weak seal portion by partially
changing the area-proportion of dots thereof. For example, the
area-proportion of dots at the central portion of the weak seal
portion 5 may be higher than that at both the end portions thereof.
In the example shown in FIG. 3, the area-proportion of dots at the
central portion of the weak seal portion 5 is made to 50% and that
of the end portion is made to 30%. In another example, the
area-proportion of dots at both side edge portions of the weak seal
portion 5 facing the small chambers of the bag may be made smaller
than the other portion thereof and, in the example shown in FIG. 4,
the area-proportion of dots at both the side edge portions of the
weak seal portion 5 facing the small chambers 7a and 7b of the bag
is made to 30% and that at the central portion between both the
side edge portions is made to 50%. In a further example, a
separable coating material is applied first to the entire portion
of the weak seal portion 5 and, then, the separable coating
material is additionally applied, in an overlapped manner, to a
partial portion of the weak seal portion 5. In the example of FIG.
5, the separable coating material is entirely applied to the weak
seal portion 5 on the plastic film 2 with the area-proportion of
dots of 50% and is further partially applied thereto in the
overlapped manner with the area-proportion of dots of 30%.
46. Furthermore, discharge members 8a and 8b made of plastic
material are provided for the upper and lower end portions, as
viewed in FIG. 1, for example, of the infusion solution bag 1A. The
discharge members 8a and 8b have tip end portions to which flanged
portions 10 are formed so as to extend bilateral directions, and
these flanged portions 10 and the inner surface of the peripheral
portion of the plastic film 2a or 2b are heat-sealed. The discharge
members 8a and 8b are formed with inner flow passages 9
communicating the inner spaces of the chambers with a space outside
the infusion solution bag 1A, and the flow passages 9 are closed by
means of rubber plugs.
47. When a pressure is applied to the infusion solution bag 1A, the
weak seal portion 5 thereof is separated and opened so that the
infusion solutions or the like in the respective small chambers of
the bag 1A are mixed together, and the mixed solution can be
discharged outward by, for example, piercing a needle of an
injector attached to one end of an instillation tube to the rubber
plug applied to the discharge member 8a (8b) of the infusion
solution bag 1A.
48. The infusion solution bag 1A of the structure mentioned above
will be manufactured in the following manner.
49. First, a flexible plastic film as a material for forming an
infusion solution bag is cut, as shown in FIG. 6, to prepare
plastic films 2a and 2b constituting front and back wall portions
(front and back side surfaces) of the bag. There will be used, as a
preferred material of such plastic film, flexible polypropylene
(PP) film, plasticized polyvinyl chloride (PVC) film, flexible
linear low density polyethylene (LLDPE) film, flexible ethylene
vinyl acetate (EVA) copolymer film or the like. Further, a
composite film formed by laminating a plurality of layers of
different plastic materials may be used as a material for an
infusion solution bag. It is desired for such film to have a
thickness of about 200 to 500 .mu.m. As occasion demands, a heat
seal layer may be additionally formed to an inside surface of the
plastic film, particularly, at portions constituting the peripheral
edge portion and the boundary portion of the infusion solution bag
by coating a heat seal material to these portions.
50. Next, with reference to FIG. 7, a separable coating material is
applied to the area, constituting the weak seal portion 5, shown
with oblique lines in FIG. 7, of the inside surface of the plastic
film 2a as the front wall portion of the bag. In usual, a
positioning mark 12 is applied to an inconspicuous portion of the
plastic film and the separable coating material is then applied to
the predetermined portion with reference to this mark 12. Although
the coating method is not specifically defined, a print coating
method may be most preferred in various coating methods for the
reason that the print coating method is most suitable for coating
the material in optional pattern.
51. It is to be noted that it is required for the separable coating
material to have a property for suppressing a bonding strength of
the heat-sealed bonded surface and also have a heat-resisting
property and a safeness for a human body. In this aspect, as the
separable coating material, there will be used various hardenable
type coating agents included in silicones, polyvinyl chloride
compounds, epoxy compounds, polyesters, or the like materials.
Among these materials, the hardenable type silicone separable
agents (release agents) will be most suitable in the viewpoint of
safeness. Although the hardenable type silicone separable agent is
used as a release agent which is coated to a release paper of a
tack label or adhesion tape, it is necessary for the separable
agent for the present invention to have safeness property for the
human body. In this viewpoint, one desired coating material for the
present invention will be a silicone release agent which can be
hardened by the use of platinum catalyst. Standards or references
of materials for medical use are different in respective countries,
and in Japan, it is necessary for the separable coating material to
pass test required for plastic containers for infusion solutions on
the basis of the Japanese Pharmacopoeia.
52. The easily separable coating material may be applied to an area
6 (enclosed with dotted lines in FIG. 7) which has a width slightly
wider than that of an area (shown with one-dot-chain line in FIG.
7) constituting the boundary portion 4. When the easily separable
coating material is applied to such wide area 6, the positional
alignment between this area 6 and the area constituting the
boundary portion 4 can be easily performed. However, it is more
preferable to coat the separable coating material with the same
width as that of the area constituting the boundary portion 4 for
the reason that when the coating material is applied with the same
width, the infusion solution in the bag does not contact the
applied separable coating material. Further, the separable coating
material may be applied to the inside surface of the plastic film
2b of the back wall portion forming the weak seal portion as well
as the inside surface of the plastic film 2a of the front wall
portion.
53. In a further process, as shown in FIG. 8, both the plastic
films 2a and 2b are overlapped so that the inside surfaces thereof
face each other, and then, the discharge members 8a and 8b are
provided to the predetermined positions so that the flanged
portions 10 of these discharge members 8a and 8b are interposed
between the plastic films 2a and 2b. Further, a single sheet of
plastic film may be used as the plastic films 2a and 2b, and in
this case, the single plastic film sheet is folded at the central
portion thereof so as to form the front wall side plastic film 2a
and the back wall side plastic film 2b.
54. In a further succeeding process, as shown in FIG. 9, the areas
constituting the peripheral edge portions 3 and the boundary
portion 4 of the infusion solution bag 1A are heat-sealed, and at
this process, as to the area constituting the boundary portion 4,
all the portions including the weak seal portion 5 and the other
portions are heat-sealed. Further, at this time, since the filling
of the infusion solution has not been completed, it will be desired
that the areas constituting the peripheral edge portions 3 and the
boundary portion 4 remain unsealed partially, i.e. one portion to
each area, without heating so as to provide infusion solution
filling ports 11a and 11b. However, in a case where the infusion
solution is fed into the bag 1A through the discharge members 8a
and 8b, it is not necessary for the unsealed portion to remain
because the infusion filling ports can be automatically formed by
mounting the discharge members 8a and 8b to the infusion solution
bag 1A. As the heat sealing method, in the present invention, a
bar-seal method, a high-frequency seal method, an ultrasonic-seal
method or other known heat seal methods will be utilized.
55. Thereafter, the infusion solutions or other substances are
filled up in the respective small chambers. In this time, it is
necessary to fill at least one of the small chambers with the
infusion solution and it may be possible to fill the other small
chamber with a medicament such as powder medicament or a little
amount of medicament solution other than the infusion solution.
However, when the medicament other than the infusion solution is
utilized, a little amount thereof is generally used, so that the
other small chamber will have a relatively small volume. After the
filling of the infusion solutions or the like, the filling ports
11a and 11b are heat-sealed and the flow passages 9 of the
discharge members 8a and 8b are closed by means of rubber plug. A
retort sterilization or other treatment will be performed as
occasion demands. The infusion solution bag 1A such as shown in
FIG. 1 can be manufactured by performing the above-mentioned
processes.
56. The bonding strength of the plastic film 2a forming the front
wall portion and the plastic film 2b forming the back wall portion
at the weak seal portion 5 can be adjusted by selecting the
separable coating materials or changing the heat-sealing
temperature or heat-seal pressure, and preferably, it is desired to
apply the easily separable coating material in dot-shape pattern
while changing the area-proportion of the dots, thus performing the
fine adjustment. Furthermore, according to the adjustment by using
the area-proportion of dots, the stable sealing strength can be
always achieved and all the products have uniform sealing strength.
The easily separable coating material can be easily printed in the
dot-pattern by the printing method and, in this method, the
area-proportion of dots can be optionally changed.
57. In one experimental example, two films of polypropylenes each
having a thickness of 300 .mu.m were overlapped and then
heat-sealed at a heating temperature of 210.degree. C. with a
sealing pressure of 2 kg/cm.sup.2 for 3 seconds, thus forming a
test piece having a width of 15 mm. When such overlapped plastic
films were separated, the sealing strength was about 5.1 kg/15 mm
(width). On the contrary, a hardenable-type separable agent of
silicones was applied to the inside surface of one of the same
polypropylene films in the dot-pattern having an area-proportion of
dots of 50% as shown in FIG. 10 through the printing method and
then heat-sealed with the same conditions mentioned above. In this
case, the sealing strength was adjusted to about 1.4 kg/15 mm
(width). Furthermore, in the same manner, when the hardenable-type
separable agent of silicones was applied to the inside surface of
the other one of the polypropylene films in the dot-pattern having
an area-proportion of dots of 30% as shown in FIG. 11 through the
printing method and then heat-sealed with the same conditions
mentioned above. In this case, the sealing strength was adjusted to
about 2.7 kg/15 mm (width).
58. The suitable sealing strength of the weak seal portion to be
determined differs in accordance with the differences of the
amounts of the inner contents of the infusion solution bag, the
kind of users such as man or woman, or other conditions. According
to the infusion solution bag of the present invention, the sealing
strength can be finely and optionally adjusted by changing or
adjusting the area-proportion of dots.
59. In a case where the mixing order of the infusion solutions or
the like in the respective chambers is not so important, the
infusion solution bag will be formed to have a general structure
provided with a linear weak seal portion such as shown in FIG. 1.
However, in a case where the infusion solutions or the other
medicament in the chambers have a combination having a fear of
being denatured or discolored if the mixing order thereof is not
correctly carried out and, hence, in a case where it is necessary
to carry out the mixing thereof with the predetermined order, it is
required for the infusion solution bag to be formed with the small
chambers having shapes or positions suitable for carrying out the
correct mixing order of the inner contents. According to the
present invention, since the weak seal portion is formed by
applying the separable coating material on the inside surface of
the plastic film, the boundary portion including such weak seal
portion can be formed so as to have an optional pattern, and
accordingly, small chambers each having an optional shape can be
easily formed to an optional position. Furthermore, according to
the printing method such as gravure printing method, the separable
coating material can be particularly easily applied in the desired
pattern shape.
60. FIG. 12 shows another example of an infusion solution bag 1B of
the present invention. In this infusion solution bag 1B, the
boundary portion 4 has a central portion protruded towards a small
chamber side 7d so as to provide a V-shape in a manner such that
the inner space of a small chamber 7c is narrowed towards the weak
seal portion 5 formed between the small chambers 7c and 7d.
According to this structure, when the small chambers 7c of the
infusion solution bag 1B is pressed, the inner pressure applied to
the small chamber 7c is concentrated to the narrowed central
portion thereof, i.e. toward the weak seal portion 5, and
therefore, when the weak seal portion 5 is separated and opened,
the infusion solution in the small chamber 7c flows into the other
small chamber 7d. On the contrary, according to the structure of
FIG. 12, if the small chamber 7d is erroneously pressed, the inner
pressure is hardly concentrated to the central portion thereof,
i.e. the weak seal portion 5, so that the weak seal portion 5 will
be hard to be separated and opened, and hence, the flow of the
infusion solution from the small chamber 7d to the small chamber 7c
will be hardly caused.
61. FIG. 13 shows a further example of an infusion solution bag 1C
of the present invention provided with three small chambers 7e, 7f
and 7g into which different three kinds of infusion solutions are
accommodated. In this infusion solution bag 1C, the boundary
portions 4 between the small chamber 7e and the small chambers 7f
and 7g have central portions narrowed, i.e. protruded, towards the
small chamber side so as to provide a V-shape in the manner similar
to that mentioned above. According to this structure, the small
chamber 7e is first pressed so as to mix the infusion solution
therein with the infusion solution contained in the small chamber
7f by flowing the infusion solution in the small chamber 7e into
the small chamber 7f through the opened weak seal portion 5, and
thereafter, the small chamber 7e is again pressed so as to mix the
infusion solution therein with the infusion solution contained in
the small chamber 7g by flowing the first mixed infusion solution
in the small chamber 7e into the small chamber 7g to thereby mix
all the infusion solutions in the chambers 7e, 7f and 7g. According
to this structure, the direct mixing between the infusion solutions
in the small chambers 7f and 7g can be prevented, and it is not
necessary to form any weak seal portion between the small chambers
7f and 7g because the infusion solutions in these chambers are
mixed through the small chamber 7e. Further, if the infusion
solution bag 1C is formed so that the sealing strengths between the
weak seal portions of the small chambers 7f and 7g is different,
the above mentioned mixing will be more accurately performed.
62. As mentioned above according to the present invention, the
infusion solution bag provided with a plurality of small chambers
into which the infusion solutions and/or medicaments are
accommodated respectively and which have the weak seal portions
closed with suitable sealing strength to be easily separable can be
effectively manufactured. Furthermore, the sealing strength of the
weak seal portions can be optionally adjusted finely in accordance
with the requirements to be used, and the thus manufactured product
infusion solution bags provide uniform sealing strength.
63. Still furthermore, according to the present invention, since
the small chambers can be formed so as to have optional shapes at
desired positions, the mixing of the inner contents of the
respective small chambers can be correctly performed.
64. It is to be noted that the present invention is not limited to
the described embodiments and many other changes and modifications
may be made without departing from the scopes of the appended
claims.
* * * * *