Note: Descriptions are shown in the official language in which they were submitted.
lZ4~647
Description
Multiple Chamber Container With
Inner Diaphragm and In~ermediate Chamber
Back~round of the Invention
In the medical field it is often necessary to mix two
separate components such as a mixture of a drug and a
diluent or a mixture of dextrose and amino acids. Such
mixtures must often be stored separately. In the case of
amino acids and dextrose, for example, the mixture is not
stable over long time periods. Such instability may also
be the case for the mixture of a drug and a diluent.
Also, some drugs lose their efficacy when stored in a
liquid diluent and must be stored dry, such as a powdered
drug stored in a drug vial of standard construction. Some
components are sterilized differently and for this reason
may be combined only after each component is separately
sterilized. For example, most liquid diluents, such as
sterile water or sterile dextrose solution, are sterilized
1~4~b~47
--2--
by steam sterilization, or autoclaving. ~he heat
generated during such a sterilization procedure may
destroy the efficacy of many powdered drugs which must be
sterilized by other means.
In addition to maintaining two components separately
during storage, there is a need for a quick and easy means
for selectively mixing the two components, in a closed
system under sterile conditions. It is known to provide a
multiple chamber container of flexible plastic sheets with
a heat seal dividing the container into two or more
chambers. Such is shown, for example, in U.S. Patent No.
4,396,383 to Hart, assigned to the assignee of the present
invention, directed to a container which employs frangible
valves between the heat seal to allow for selective
communication and mixing between the two components stored
in the two chambers.
Other means for establishing a closed system for the
separate storage and 3elective mixing of two components
is shown in U. S. Patent No. 4,410,321, issued
October 18, 1983, Pearson et al., and
assigned to the assignee of the pre~ent invention. The
device shown therein utilizes a preferably plactic junc-
tion about the end portions of container and chamber
access means to allow for the separate storage and selec-
tive mixing of two components euch as a powdered drug anda liquid diluent.
It i6 desirable to provide a multiple chamber closed
sy~tem which does not require additional elements inte-
grated into the container to form the openable valve
between the compartments. Such are shown, for example, in
U.S. Patent No~. 3,950,158, 4,000,996 and 4,226,330. In
each of these patents there is disclosed a multiple
chamber container which has a line of weakness, such as a
score line in pla~tic material, which breaks upon the
application o~ pressure.
~Z9~ i47
--3--
Tear tabs or tear strips for plastic packaging are
also known, such as shown in U.S. Patent No. 2,991,000.
Such tear tabs provide ready access to the contents of a
container but also involve the use of a relatively compli-
cated seal structure. U.S. Patent No. 3,983,994 discloses
a peelable seal broken by pulling upon tabs located out-
side of the container.
Rupturable seal lines such as shown in the above named
patents may all suffer from the common problem of ruptur-
ing before communication between the two chambe-s is
intended. The rupturable seal lines are designed to be
weaker than the remainder of the container so that upon
the application of force the rupture line breaks first.
It is also desirable to provide a multiple chamber
closed container having a selectively openable seal line
between the chambers which when closed virtually
eliminates the transmission of moisture into one of the
chambers from either outside of the container or from the
other chamber. Such a requirement may be necessary when,
for example, a powdered drug is stored in one of the
chambers of the container.
` ~Z9L~647
--4--
An aspect of this invention is as follows:
A container having two chambers for the separate
storage and selective mixing of two components, comprising:
(a, a first sheet including
(i) a first inner surface of a
thermoplastic material, and
(ii) a first outer surface;
(b) a second, diaphragm sheet including
(i) a second inner surface of a
thermoplastic material, said second inner
surface having melt-flow characteristics
substantially identical with the melt-
flow characteristics of said first inner
surface, and
(ii) a second outer surface;
(c) said second, diaphragm sheet sealed about at
least a portion of its periphery to said first sheet
and to a third sheet opposite said first sheet;
(d) said first sheet and said third sheet sealed
about their entire peripheries, forming the exterior
wall of said container;
(e) an externally, selectively, manually openable
seal line between said first and said second,
diaphragm sheets, said openable seal line extending
across the width of said container, wherein a cross
section taken through said seal line, perpendicular
to said seal line at the cross section defines a
seal, said seal formed by applied pressure and a
focused energy source, which melts said first and
second inner surfaces at said seal, said seal
defining
(i) a bead area of increased thickness at
a break end of said seal, between said
first and second inner surfaces, said bead
area of increased thickness coextensive
with said first and second inner surfaces
along less than all of the surface of said
bead area,
12~ 7
-4a-
(ii) a break line inwardly of said break
end, between said second, diaphragm sheet
and said bead area of increased thickness,
the thickness of said seal at said break
line being at the least not substantially
less than the thickness of said second
sheet, and
(iii) an arcuate depression having a
concave downward surface extending from
substantially adjacent said break line to a
minimum seal thickness point;
(f) a permanent line of securement between said
second and third sheets extending substantially
parallel to and the length of said openable seal
line;
(g) at least said second, diaphragm sheet, said
openable seal line, said permanent line of securement
and said third sheet defining a first chamber for
holding the first component;
(h) at least said first sheet, said openable seal
line, said permanent line of securement and said
second, diaphragm sheet defining a second chamber for
holding the second component;
(i) barrier means secured to the exterior surface of
the exterior wall of said container, at one of that
portion of said third sheet which defines said first
chamber and that portion of said first sheet which
defines said second chamber;
(j) wherein said barrier means comprises a virtually
absolute barrier to at least one of gas, liquid and
light;
(k) whereby manual separation of said first a~d
second sheets near said openable seal line will
rupture said seal line and said second sheet, placing
said first and second chambers in open communication.
12~6~t~
-4b-
By way of added explanation, the present invention
in one aspect thereof is directed to a container
having at least three chambers for the separate storage
and selective mixing of at least two components. The
container includes a first sheet and-a second diaphragm
sheet sealed about at least a portion of its periphery to
the first sheet and also to a third sheet. The second,
diaphragm sheet is intermediate the first and third
sheets. The first and third sheets are sealed about their
entire peripheries and form the exterior wall of the
container.
A first externally, manually breakable line of
securement is disposed between the first sheet and the
diaphragm sheet. A second externally, manually breakable
line of securement is disposed between the first sheet and
the second, diaphragm sheet. At least the first breakable
line of securement, the first sheet and the second,
diaphragm sheet define a first chamber for holding the
first component. At least the second sheet, the third
sheet and the first and second breakable lines of
securement define the second chamber. Finally, at least
the first sheet, the second breakable line of securement
and the second, diaphragm sheet define a third chamber.
Manual separation of the first and second sheets near
the first and second breakable lines of securement will
rupture the breakable lines and the inner, diaphragm
sheet, placing all three chambers in open communication.
In one embodiment of the invention, the second
component is held in the third chamber and the second
chamber serves as a buffer or barrier chamber between the
first and third chambers. The buffer chamber accomplishes
two important objectives. First, it decreases the chance
of any moisture transmission between the fir~t component
which may be a liquid and the econd compon-ent which may
lZ9~ 7
--5--
be a dry powder such as a powdered drug. Second, the
buffer chamber serves as a means for visual inspection of
seal integrity. If moisture is seen in the buffer chamber
before use, the operator knows that at least one of the
breakable lines of securement is no longer intact.
In another embodiment of the invention, each of the
chambers holds a separate substance such as, for example,
amino acids, dextrose and lipids.
In the preferred embodiment, first and second
permanent lines of securement are formed between the
second and third sheets, each extending substantially
parallel to, and substantially the length of, the
corresponding breakable line of securement.
The container of the present invention provides a
relatively inexpensive and reliable means for separately
storing two or more substances in a closed system, while
providing for quick and easy selective mixing of the
substances when desired.
lZ~364'^~
-6-
Description of the Drawings
Fig. 1 is a cross-sectional view of the selectively
openable seal line, illustrating the formed seal.
Fig. 2 is an enlarged, fragmentary cross-sectional
view illustrating the seal shown in Fig. 1 and the break
line and break end.
Fig. 3 is a cross-sectional view of the seal line as
in Fig. 1, after the seal has been broken at the break
line.
Fig. 4 is a perspective view of a container, including
the openable seal line disposed between the container
exterior and a pull tab.
Fig. 5 is a perspective view of a container similar to
that shown in Fig. 4.
Fig. 6 iA a perspective view of the container shown in
Fig. 5, during opening of the seal along the seal line.
Fig. 7 is a cross-sectional schematic view illustrat-
ing the sealing die before forming the selectively open-
able seal line.
Fig. 8 is a cross-sectional view illustrating the
formed eal and sealing die.
Fig. 9 is a perspective view of a sealing die.
Fig. lO is a cross-sectional view taken at line lO-lO
of Fig. 9-
Fig~ lOA is a cross-sectional view of the selectively
openable seal line in Fig. 6, made with the die of Figs. 9
and lO, taken at line lOA-lOA of Fig. 6 and illustrating
the seal and mirror image seal.
Fig. 11 is a perspective view of a container having an
inner diaphragm sheet and the selectively openable seal
line.
Fig. llA is a cross-sectional view taken along the
length of the container as shown at line llA-llA of Fig.
11, but after the seal line has been broken.
124(~6~7
--7--
Fig. 12 is a perspective, cutaway view of the con-
tainer of Fig. 11.
Fig. 13 is a cross-sectional view of the openable seal
line and permanent line of securement taken at line 13-13
of Fig. 11, illustrating the formed seal.
Fig. 14 is an enlarged, fragmentary side elevational
view of a portion of the seal line of the container shown
in Fig. 11.
Fig. 15 is a cutaway perspective view of a sealing die
utilized in making the openable seal line of the container
of Fig. 11.
Fig. 16 is a top plan view of the sealing die shown in
Fig. lS.
Fig. 17 is a cross-sectional view taken along line
17-17 of Fig. 16.
Fig. 18 is a schematic view illustrating the manu-
facturing process for the container.
Fig. 19 is a side elevational view of an alternate
structure to the container of Fig. 11.
Fig. 20 is a perspective view of a further modified
container.
Fig. 21 is a perspective view of a still further
modified container.
Fig. 22 is a cutaway view of the container illustrated
in Fig. 21.
Fig. 23 is a perspective view of a container utilizing
peelable barrier means.
Fig. 24 is a perspective view of the container as in
Fig. 23, with the peelable barrier means partially peeled
away.
Fig. 25 is a cutaway view of the container shown in
Fig. 23.
Fig. 26 is an alternate embodiment of the container
shown in Fig. 23.
lZ~647
--8--
De~ailed Descri tion of the Preferred Embodiments
P
Referring to Figs. 1 through 6 and lOA, and
particularly Figs. 4 and 5, there are illustrated con-
tainers 30 and 31 having pull taps 32 and 33, respec-
tively, utilizing the unique selectively openable seal
line 34. The seal line 34 includes seal line portion 34A
and mirror image seal line portion 34B.
A cross-section of the seal line portion 34A is seen
in Figs. 1 through 3. A cross-section of the seal line 34
is seen in Fig. lOA. These Figures show the formed seal
36 between a first sheet 38 and a second sheet 40. In
other words, the seal is the cross-section of the seal
line.
The first sheet 38 corresponds to the pull tabs 32, 33
of the containers 30, 31, respectively. The second sheet
40 corresponds to the sidewalls 41, 42 of the containers
30, 31, respectively. The seal 36 illustrated in Figs. 1
through 3 may also be utilized in the containers shown in
Figs. 11, 19, 20, 21, 23 and 26.
The first sheet 38 includes a first inner urface 44
of a thermoplastic material and a first outer surface 46.
The second sheet 40 includes a second inner surface 48 of
a thermoplastic material and a second outer surface 50.
The second inner surface 48 has melt-flow characteristics
substantially identical with the melt-flow characteristics
of the first inner surface 44. Preferably, the first and
second inner surfaces 44, 48 are made of the same
material. As will be seen later, the first and second
sheets may be laminated or coextruded structures including
multiple layers of materials to impart different
properties to the sheets.
The first and second inner surfaces 44, 48 are secured
to each other at the seal 36. The seal 36 and therefore
the seal line 34 are formed by a focused energy source
~LZ~47
which melts the first and second inner surfaces 44, 48 at
the seal 36. Preferably, the focused energy source is
radio-frequency (RF) energy applied through a unique seal-
ing die 52, seen, for example, in Figs. 7 and 8. The term
"focused energy" is not meant to include conductive heat
energy but may include ultrasonic energy. The seal 36 is
also preferably made by applied pressure as well as by the
focused energy.
The unique seal 36 formed between the sheets 38, 40 at
the inner surfaces 44, 48, respectively is illustrated in
Figs. 1 through 3, showing the formed seal 36 along a
cross-section taken through the seal line 34, at portion
34A, perpendicular to the seal line 34. Referring to Fig.
2, this seal 36 includes a bead area of increased thick-
ness 54 at a break end 56 of the seal 36, between the
first and second inner surfaces 44, 48, respectively. The
bead area of increased thickness 54 is coextensive with
the first and second inner surfaces 44, 48 along less than
all of the surface of the bead area. Thus, in Figs. 1
through 3 there is shown a space between the first andsecond sheets 38, 40 to the left of the break end 56.
Unlike what might be expected, the seal 36 breaks at a
break line 58 which is disposed inwardly of the break end
56 and between the second sheet 40 and the bead area of
increased thickness 54. The break line 58 defines the
boundary between the second sheet 40 and the bead area
54. The width of this boundary area defined by the break
line 58 i5 at the least not substantially less than the
thickness of the second sheet 40. In fact, the width of
the boundary area may be equal to or greater than the
thickness of the second sheet 40.
The seal 36 further includes an arcuate depression 60
including a concave downward surface 62 extending from
~ubstantially adjacent the break line 58 to a minimum seal
647
--10--
thickness point 64. It is important to note that the seal
does not break at the minimum seal thickness point 64.
The distance between the minimum seal thickness point 64
and the first outer surface 46 is preferably not less than
the thickness of the first sheet 3B and at the most not
substantially greater than the thickness of the first
sheet.
The arcuate depression 60 preferably also includes a
concave upward surface 66 extending upwardly from the
minimum seal thickness point 64, away from the concave
downward surface 62.
The seal 36 also preferably includes a beveled surface
68 defined by the second outer surface 50, beyond the
concave upward surface 66. The beveled surface 68
preferably begins adjacent the concave upward surface 66.
The thickness of the seal 36 increases along the beveled
surface 68 from the concave upward surface 66 to a bevel
end 70 of the seal 36.
The bevel end 70 may be defined in part by a secondary
bead area 72 of excess material. The second sheet 40
extends away from the seal 36 intermediate the beveled
surface 68 and the secondary bead area 72.
The thickness of the second sheet 40 is at the most
not substantially greater than the thickness of the first
sheet 38. Preferably, the thickness of the second sheet
40 is less than the thickness of the first sheet and, most
preferably, at least about 0.003 in. less than the thick-
ness of the first sheet 38. For illustration purposes
only and not as a limitation, the first sheet may have a
thickness of 0.015 in. and the second sheet may have a
thickness of 0.010 in.
By way of example only, and not intended as limiting
the invention, the following are other sample measurements
for the seal 36. The width of the arcuate depression may
~Z~(~647
--11--
be about 0.02 in. The bevel may extend away from the
arcuate depression 60 at an angle of approximately 5 from
horizontal. The width of the seal from the beginning of
the arcuate depression 60 to the bevel end 70 may be about
1/8 in.
As stated earlier, the first and second inner surfaces
44, 48 are preferably of the same material. It is
believed that polyvinyl chloride, ethlyene vinyl acetate
(EVA) and SARAN are all materials which work well in
making the seal 36. The entire sheets may be made of
these materials or just the inner surfaces.
While the mixing of the material from the first and
second sheets 38, 40 at the seal 36 is not known, it i5
believed to approximate the phantom boundary line 74 seen
in Fig. 2. In one test, the first sheet 38 was dyed a
distinctly different color than the second sheet 40. The
seal 36 was then made, resulting in a boundary such as
shown at line 74. Thus, it i9 believed that the bead area
of increased thickness 54 comprises material from both of
the first and second sheets 38, 40. However, it is also
believed, but not known, that the break line 58 com~rises
material only from the second sheet 40. Thus, the phantom
break line 58 illustrated in Fig. 2 is not intended to be
a part of phantom boundary line 74.
Referring now to Figs. 7-10 there are illustrated
~ealing dies for making the seal lines such as the seal
line 34 shown in the containers 30, 31 illustrated in
Figs. 4-6, as well as the method for making the seal
line. The sealing die 52 includes a metal die head 76 and
an unheated or cold plate 78 opposite the die head 76.
The first and second sheets 38, 40 are mounted between the
die head 76 and the plate 78 during formation of the seal
line 34.
~2~ 7
-12-
Figs. 7 and 8 illustrate the metal die head in
cross-section. The metal die head 76 has first and second
die sides 80, 82, respectively. Immediately adjacent the
first die ~ide 80 is a convex rounded projection 84. The
convex rounded projection 84 merges at one side thereof
into the first die side 80 at a first die side end 86.
The convex rounded projection 84 further includes a point
of maximum projection 88. A bevel 90 extends from the
rounded projection 84 to the second die side 82 at a
second die side end 92. The bevel 90 recedes from the
point of maximum pro jection 88 in the vertical direction.
For purposes of this application, the words "horizontal"
and "vertical" are made with reference to the drawings
only. It should be understood that, for example, the seal
line 34 may be formed with the sheets 38, 40, metal die
head 76 and unheated plate 78 oriented ninety degrees or
any angle from that shown in Figs. 7 and 8~
The vertical distance between the point of maximum
projection 88 on the rounded projection 84 and the second
die side end 92 is preferably greater than the vertical
distance between the point of maximum projection 88 and
the first die side end 86. It is believed that the
vertical distance between the first die side end 86 and
the point of maximum projection 88 should not be greater
than the thickness of the second sheet 40. The bevel 90
extends away from the rounded projection 84 at approxi-
mately 5 from horizontal. The vertical distance between
the first die side end 86 and the point of maximum projec-
tion 88 may be in the range from about 0.007 to about
0.008 in. for example. The rounded projection 84 may have
a width of about 0.020 in. The width of the sealing die
between the first and second die side6 80, 82 may be about
1/8 in. These sample measurement6 of the sealing die
would be appropriate when utilizing first and second
124~47
-13-
sheets 38, 40 having thicknesses of about 0.015 and 0.010
in., respectively.
As ~tated above, the seal 36 and resulting seal line
34 are formed by mounting the first and second sheets 38,
40 between the metal die head 76 and unheated plate 78.
Focused energy is applied through the die head 76 and is
preferably radio-frequency (RF) energy. The die head 76
is lowered into contact with the second sheet 40.
Pressure may be applied simultaneously with the focused
energy. After the seal 36 is formed, the metal die head
76 is lifted away, such as shown in Fig. 8.
The specific seal lines shown in the containers of
Figs. 4-6 include, in addition to the seal 36, a mirror
image seal 36' substantially identical to the seal 36.
The mirror image seal 36' is a cross-section of the seal
line portion 34B. Figs. 9 and 10 illustrate the die 98
for such a seal line 34. Referring back to Fig. 6, the
seal line begins at a seal line opening end 94. The seal
36 and the mirror image seal 36' commence from the common
seal line opening end 94 which corresponds to the sealing
die end 96 of the sealing die 98 illustrated in Figs. 9
and 10. The portions 34A, 34B of the seal line 34
initially extend away from each other from the seal line
opening end 94 at an angle less than 180.
The seal line 34 utilized in the container of Figs.
4-6 is best illustrated in Fig. lOA, ~howing both the seal
36 and the mirror image seal 36'. The cross-section of
the combined seal 36 and mirror image seal 36' illustrated
in Fig. lOA is the preferred embodiment for the seal line
34 used with the tear tab arrangement of the containers
shown in Figs. 4-6. Here, the seal break line 58 and the
mirror image break line 58' are separated by the seal
arcuate depression 60 and the mirror image seal arcuate
~Z9~47
-14-
depression 60'. This arrangement corresponds with the
sealing die 98 illustrated in Figs. 9 and 10.
It is possible that the seal and mirror image seal
could be revexsed such that the seal arcuate depression
and the mirror image seal arcuate depression are separated
by the seal break line and the mirror image break line.
In such a construction, the break lines would thus be in
the inner, facing portions of the seal line as opposed to
the outer, opposite portions of the seal line illustrated
in Fig. lOA. Preferably, the seal line portions 34A, 34B,
corresponding to the seal 36 and mirror image seal 36',
respectively, initially extend away from each other at an
angle not greater than about 90. The portion 38A shown
in Fig. lOA corresponds to the inner area 33A of the pull
tab 33 shown in Fig. 6. The portion 40A corresponds to
the inner area 42A of the container sidewall 42 which is
removed with the tab 33. The inner area 42A is secured to
the tab 33 along the seal line 34.
As seen in Fig. 6, the seal line portions 34A, 34B,
after initially extending away from each other from the
seal line opening end 94, extend in substantially parallel
relation at a distance between break lines 58, 58' of not
greater than about one-half inch, in the preferred embodi-
ment.
The sealing die 98 illustrated in Figs. 9 and 10 for
producing the combined seal 36, 36' illustrated in Fig.
lOA includes both a metal die head 76 and a mirror image
metal die head 76', each including, respectively, first
die sides 80, 80' and second die sides 82, 82'. The die
head 76 may be the same as the die head 76 shown in Figs.
7 and 8 as part of the sealing die 52. While a seal and
seal line can be made from the sealing die 52, the sealing
die 98 is utilized with the seal lines 34 shown in the
containers 30, 31.
124(~f~4~
-15-
Each die head 76, 76' inclucles a convex rounded pro-
jection 84, 84' merging at one side thereof into its
respective first die side 80, 80' at a respective first
die side end 86, 86'. Each convex rounded projection 84,
84' has a corresponding point of maximum projection, 88,
88'. A bevel 90, 90' extends from each of its respective
rounded projections 84, 84' to its respective second die
side 82, 82' at a respective second die side end 92, 92'.
As discussed relative to Figs. 7 and 8, each of the bevels
90, 90' recedes from the respective point of ma~imum pro-
jection 88, 88' in the vertical direction. The die head
76 and mirror image die head 76' correspond to the seal
line portion 34A and the mirror image seal line portion
34B of the seal line. The die head 76 and mirror image
die head 76' converge at a sealing die end 96 correspond-
ing to the seal line opening end 94.
Vertical distance between each point of maximum pro-
jection 88, 88' and its respective second die side end 92,
92' is greater than the vertical distance between each
point of maximum projection 88, 88' and the respecti~e
first die side end 86, 86'.
It should be noted that although the seal line 34 is
made by the sealing die 98 in the preferred construction
for the tear tab arrangement on the containers shown in
Figs. 4-6, it is quite possible to construct the tear tab
arrangement utilizing only the seal line 34A comprising
the seal 36 without the mirror image seal 36'. The con-
struction of ~uch a seal line would be made with the
sealing die 52 shown in Figs. 7 and 8 without the mirror
image metal die head 76'. ~he resulting seal line could
be a straight line. Whereas the seal line 34, shown for
example in Fig. 6, creates an open area when opened, a
single seal line portion 34A would create a tear line in
the bag material when opened, as opposed to an open area.
647
-16-
Also, it is believed that the single seal line portion 34A
may be more susceptible to inadvertent opening than is the
seal line 34 having both seal 36 and mirror image seal
36'.
The container 30, 31 described above may be used for
storage where quick access is necessary. For example, the
containers may be used to store "slush", a partially
frozen medical solution used during surgery. The con-
tainer may have an outer wrap which is removed outside the
operating circle. The tear tab may be broken by a sterile
operator within the operating circle.
Referring now to Figs. 11-14, there is shown a uni~ue
multiple-chamber container 100. The container 100
includes a first sheet 102, a second, diaphragm sheet 104
and a third sheet 106. The first sheet 102 and the second
sheet 104 correspond to the sheets 38 and 40 respectively
in the discussion relative to Figs. 1-3.
The first sheet 102 includes a first inner surface 108
and a first outer surface 110. The second, diaphragm
sheet 104 includes a second inner surface 112 and a second
outer surface 114. The third sheet 106 includes a third
inner surface 116 and a third outer ~urface 118.
The first, second and third sheets 102, 104, 106 are
sealed together about their peripheries. The second
diaphragm sheet 104 is sealed about at least a portion of
its periphery such as shown in Fig. 19, discussed below,
but in the preferred embodiment is sealed about its entire
periphery, intermediate the first and third sheets 102,
106, as seen in Figs. 11 and llA. The first and third
sheets 102, 106 form the exterior wall of the container
100 .
The sheets 102, 104, 106 are preferably flexible and
it is preferred that each sheet is made at least partially
of a thermoplastic. The peripheries of the first, second
lZ~6~7
-17-
and third sheets 102, 104, 106 may be sealed with a
~tandard heat seal.
An externally, manually breakable line of securement
120 is made between the first sheet 102 and the second,
diaphragm sheet 104. The breakable line of securement 120
may be the ~electively openable seal line having the seal
36 discussed above, in order to provide an extremely
secure seal which is not eaæily opened unintentionally but
which may be selectively opened when desired. Also, the
selecti~ely openable seal line, such as discussed with
rçference to Figs. 1-10, for example, opens in a predeter-
mined manner without creation of loose material which
could contaminate the container contents. However, the
breakable line of securement 120 may be of some alternate
construction. In order to provide quick communication and
mixing between the components in the two chambers of the
container 100, the breakable line of ~ecurement 120
extends across the entire width of the container, although
this is not necessary to the operation of the container.
The breakable line of securement 120 has a substantially
chevron shape.
Port means such as a tubular port assembly 122 may be
mounted in the container 100 to communicate with the
interior of the container 100. The tubular port assembly
122 may include a sealing membrane (not shown) capable of
being pierced by, for example, the cannula or spike of a
parenteral administration set for delivery of the con-
tainer contents through the administration set to the
intravenous system of a patient.
The second, diaphragm sheet 104, the breakable line of
securement 120 and the third sheet 106 together define a
first chamber 124 for holding the first component 126 to
be stored. The first sheet 102, the breakable line of
securement 120 and the ~econd, diaphragm sheet 104
lZ4(~7
-18-
together define a second chamber 128 for holding the
second component 130 to be stored.
Although not necessary, it is highly preferred that
the container 100 also include a permanent line of secure-
ment 132 between the second, diaphragm sheet 104 and the
third sheet 106. The permanent line of securement 132
extends substantially parallel to and substantially the
length of, the breakable line of securement 120. With the
inclusion of the permanent line of securement 132 the
first chamber 124 and second chamber lZ8 are further
defined by the permanent line of securement 132. The
permanent line of securement 132 may be a standard heat
seal, for example, such as shown by the seal 134 in Fig.
13. The seal 134 refers to the cross-sectional configura-
tion of the permanent line of securement 132. A
cross-sectional view of the breakable line of securement
120 is the breakable seal 136 which is illustrated, for
example, in Figs. llA and 13 as the seal 36 of the seal
line 34. One again, however, it should be noted that the
breakable line of securement 120 may include seal lines
other than the unique seal line 34.
Fig. 12 is an enlarged fragmentary view of the seal
structure of the container 100. The two phantom lines
correspond to the two ends 134A, 134~ of the heat seal
134. The solid line closest to the phantom line repre-
sents the break end 56 of the seal 136. The other solid
line represents the secondary bead area 72.
As illustrated in Fig. 11, it may be desirable to
extend the breakable line of securement 120 entirely
across the container, spanning the peripheral seal 138 of
the first and second sheets 102, 104. This creates a
first chamber portion 104A of the second, diaphragm sheet
104. Thus, the second chamber 128 is exclusive of a
lZ~ 7
--19--
boundary with the first chamber 124 at the first chamber
portion 104A of the second diaphragm sheet.
Similarly, it would then be desirable to extend the
permanent line of securement 132 entirely across the
container 100, spanning the peripheral seal 140 of the
second and third sheets 104, 106, thereby creating a
second chamber portion 104B of the second sheet bounded in
part by the permanent line of securement 132. Thus, the
first chamber 124 is then exclusive of any boundary with
the second chamber 128 at the second chamber portion 104B
of the second sheet. When, as is preferred, the breakable
and permanent lines of securement 120, 132 both extend
entirely across the container, a common portion 104C of
the secona sheet is thereby created. With this configura-
tion, the first and second chambers 124, 128 share a
boundary only at the common portion 104C of the second
sheet 104.
Such a configuration has at least two distinct
advantages. First, the two components 126, 130 do not
overlap. Thus, if it is desirable to inspect the con-
tainer contents before mixing and the container wall is
transparent or translucent, it is possible to inspect each
component separately without also viewing the other
component. Secondly, and more importantly, such a
structure drastically limits the common border of the two
chambers 124, 128. This is important for limiting the
transmission of moisture or gas into one of the chambers
from the other through the material of the second sheet
104. The area is thus limited to the breakable and
permanent lines of securement 120, 132 and the common por-
tion 104C of the second sheet 104.
In this regard, the container may be made from a
variety of different plastic materials. These include,
without limitation, polyvinyl chloride, ethlyene vinyl
1~4Q647
-20-
acetate (EVA) and SA~AN . What appears to be important
when making the selectively openable seal line 34, which
may be used as the breakable line of securement 120, is
that the first inner surface 108 of the first sheet 102
and the second inner surface 112 of the second sheet 104
be thermoplastic materials having similar or identical
melt-flow characteristics, in order to enable manufacture
of the unique seal 36, 136.
~urther, in medical applications such as when amino
acids and dextrose are stored in the two chambers, it is
important to limit oxygen transmission through the con-
tainer wall into the chambers as well as limit moisture
transmission through the container walls and across the
diaphragm sheet 104. An even more critical example
includes use of the container 100 to store, for example,
dextrose or saline solution in the first chamber 124 and a
powdered drug in the second chamber 128. In this applica-
tion it is imperative that virtually no moisture be trans-
mitted into the second chamber 128 containing the dry
drug. In order to limit the transmission of moisture from
the solution in the first chamber across the common por-
tion 104C into the second chamber, it is desirable to
utilize various laminate structures in making the con-
tainer and especially in making the second diaphragm sheet
104. Two examples of exceptional moisture and gas trans-
mission barrier materials are SARAN and aluminum foil.
The second sheet 104 may be manufactured with a layer of,
for example, SARAN or foil or other high barrier property
material, allowing the inner surface 112 of the diaphragm
sheet 104 to be maintained as a thermoplastic material
similar to the material of the inner surface 108, in order
to permit a proper seal between the first and second
sheets 102, 104.
lZ4~i47
-21-
However, it must be remembered that the first and
third sheets 102, 106, as well as the second sheet 104,
may also be laminate structures comprising at least two or
more layers of material. This i5 especially important in
the medical field, such as when amino acid solution and
dextrose solution may be stored in the two chambers 124,
128. Here, it is desirable to prevent the transmission of
air into the container through the wall and to prevent the
loss of liquid out of the container.
The use of laminate structures becomes even more
critical when a dextrose or saline solution, for example,
is stored in the first chamber 124 and a powdered dry drug
is stored in the second chamber 128. Here, it is critical
that virtually no moi6ture reaches the dry powdered drug.
The saline solution stored in the adjacent chamber is
limited to transmission through the common portion 104C of
the diaphragm sheet 104. If a high vapor and moisture
barrier such as SARAN or metal foil is used in all three
sheets, virtually no moisture from the liquid in the first
chamber or from outside the container should reach the dry
powdered drug in the second chamber.
It may be seen that the container 100 provides an
excellent means for the separate storage of two
components. A nurse or other operator may selectively mix
the two components by simply grasping the first and third
sheets (i.e., the outside wall of the container) and
manually separating the two sheets, pulling them in
opposite directions, near the breakable line of secure-
ment. This action will rupture the breakable line of
securement 120 and therefore the second sheet 104 as well,
placing the first and second chambers 124, 128 in open
communication, as best seen in Fig. llA. The advantages
of utilizing the selectively openable seal line 34 as the
breakable line of securement 120 in the container 100 are
lZ9~6~'
-22-
now readily apparent. The seal line 34 is not believed
susceptible to opening upon the application of unintended
forces such as may be commonly found during shipment,
storage and handling of the container both to and in a
hospital. The selectively openable seal line 34 may,
however be easily opened by the manual separation of the
first and third sheets near the seal line. The seal line
34 breaks in a predetermined manner.
It is also believed that the unique container
structure utilizing the permanent line of securement 132
closely parallel to or opposite the breakable line of
securement 120 greatly facilitates the easy selective
breaking of the second 6heet, because the common portion
104C is stretched between the permanent seal 134 and the
breakable seal 136. The breakable seal 136 ruptures,
placing the two chambers in communication. When the
permanent line of securement 132 is not included, the
opening action by the operator is the same except that the
first and second, instead of first and third sheets are
grasped. The second sheet is grasped from the
container-exterior, so that the second and third sheets
are folded between the thumb and index finger of one
hand.
When the selectively openable seal line 34 is utilized
as the breakable line of securement 120 in the container
100, the seal line 34 may be manufactured utilizing the
sealing die 142 illustrated in Figs. 15-17. The sealing
die 142 is similar to the sealing die 98 except that,
instead of changing from initially a chevron shape to two
parallel lines, such as portions 34A, 34B, the general
chevron ~hape is used for the entire sealing die and thus
the entire line of securement 120. The chevron shape
preferably at least begins at an angle of less than 90
and may widen to an angle of less than 180. The sealing
lZ4C~647
-23-
die 142 illustrated in Figs. 15-17 includes a sealing die
end 144 shown in greater detail than the sealing die end
96 of the sealing die 98 but which may also be used in the
sealing die 98. The sealing die end 144 is the point at
which the die head 146 and mirror image die head 146'
converge and corre~ponds to the seal line opening end 148
of the breakable line of securement 120 when the openable
seal line 34 is employed. The die head and mirror image
die head 146, 146' include, about the sealing die end 144,
an end convex rounded projection 150 which is substan-
tially wider than and which narrows into the convex
rounded projections 152, 152' of the die heads 146, 146'.
Further included is a flat 154, intermediate the end
convex rounded projection lS0 and the bevel 156, 156', the
flat 154 narrowing to a point 155, 155' in both the die
head 146 and mirror image die head 146' whereat the bevel
156, 156' begins adjacent the rounded projection 152,
152'. The width of the bevel 156, 156' remains constant
throughout the entire length of the sealing die, including
the sealing die end 144.
When the selectively openable seal line 34, 120 is
made utilizing the sealing die 142, a seal line opening
end 148 results which includes an opening arcuate
depression which is substantially wider than and which
narrows into the seal arcuate depression 60 and mirror
image axcuate depression 60'. As an example, the width of
the opening arcuate depression at the opening end 148 may
be about 0.04 in. and may narrow to about 0.02 in. at the
arcuate depression 60 and mirror arcuate depression 60'
seal. The seal line 34, 120 will thus also have an open-
ing end seal 148 having a corresponding seal flat surface
intermediate the concave upward surface 66 and the beveled
surface 68. The flat surface will narrow to a point into
the seal line portion 34A and mirror image seal line
124~
-24-
portion 34B of the ~eal line 34, 120 whereat the beveled
surface 68 of the seal 136 begins adjacent the concave
upward surface. It follows that the width of the beveled
surface 68 of the seal line 34, 120 shall remain constant
through the entire length of the seal line when the seal-
ing die 142 is employed. The seal line opening end 148
corresponds to the tip of the chevron shape.
As a simple test to assure that the breakable line of
securement 120 has not been even partially opened, a tack
seal 158 may be provided between the first and second
sheets 102, 104 a~d spaced from the seal line opening end
148, the seal line opening end 14B most probably being the
weakest point in the breakable line 34, 120. The tack
seal 158 will break before the breakable line 120 opens.
The tack seal, which may be a small-area, weak heat seal,
makes a small but audible noise when broken. Thus, if the
noise is heard when breaking the line of securement 120,
one knows that the seal line opening end 148 has not been
disturbed.
~eferring now to Fig. 18, there is illustrated a
schematic view of the manufacturing procedure for the con-
tainer 100.
A continuous supply of the first, second and third
sheet6 102, 104, 106 is provided, typically in the form of
roll stock. The sheets are aligned such that the first
and third sheets 102, 106 are substantially coextensive,
with the second sheet intermediate the first and third
sheets. For purposes of illustration only, the first and
third sheets may be ethlyene vinyl acetate having a thick-
ness of 0.015 in. The second sheet 104 may have inner and
outer surfaces of ethlyene vinyl acetate and an inner
layer of SARAN or foil, the second sheet 104 having a
thickness of about 0.010 in.
~Z4~6~7
-25-
The breakable line of securement 120 is then formed.
If the container to be formed employs the openable eal
line 34 as the breakable line of securement 120, a sealing
die such as the sealing die 142 is brought into contact
with the second, diaphragm sheet 104 on the opposite side
of the first sheet 102. An unheated or cold flat plate
160 preferably of metal i8 disposed against the first
sheet 102 opposite from the ~econd sheet 104. The focused
energy is then applied through the sealing die 142.
If the breakable line of securement 120 does not
employ the openable seal line 34, but instead utilizes a
weakened seal line such as may be made by forming a line
of thinner material, the unique sealing die 142 may be
replaced with the appropriate known die to produce such a
weakened seal line.
In the preferred embodiment using the openable seal
line 34, the seal line 34 is formed utilizingan
RF Sealing Machine, Model No. KF62/SP40, ~old by Solidyne,
Inc. of Bay Shore, New York. The sealing machine is
listed at 6,000 watts and the RF energy is applied at 27
Megahertz, within six percent.
The sealing die 142 is in contact with the second
~heet 104 typically for a period of as much as five or six
seconds, although the contact time may be as little as
about three seconds and may be still further reduced. The
RF energy is preferably applied somewhere in the middle of
the contact time period and may be applied for about one
second or longer.
The openable seal line 34, illustrated by the seals
36, 136 in cross-section, is formed with the application
of relatively little pressure. For example, a peripherial
heat seal 138, 140 sealing the peripheries of the sheets
may involve the uge of ag much as 500 psi. The openable
seal line 34 utilizes presgure of probably less than 25
1~4(~647
-26-
psi. The sealing machine may be set to include a stop on
the die approximately 0.004 in. into the second sheet
104. It may indeed be possible to make the seal 36, 136
without the application of any pressure whatsoever. It is
preferred that the unheated or cold plate 160 is main-
tained at a relatively cold temperature by, for example,
water cooling the plate 160. The cold plate serves to
prevent or drastically reduce any indentation of the outer
surface 110 of the first sheet 102, i.e., it reduces the
effect of the RF energy at the outer surface 110. After
the seal line is formed, the sealing die 142 and cold
plate 160 are disengaged and the three sheets, the first
and second sheets now being attached, travel to the next
station, where the permanent line of securement 132 is
formed. The permanent line of securement may be formed
with a standard flat sealing die 162 shaped to create a
permanent line of securement 132 which runs parallel to
the breakable line of securement 120. The permanent line
of securement 132 may be made upon the application of heat
and pressure and may utilize RF energy. The standard
sealing die 162 may be urged against the third outer
~urface 118. A glass buffer 164 may be inserted between
the first and second sheet6 102, 104. The glas6 buffer
164 preferably has a cut-out end 166 corresponding with
the breakable line of securement 120, so that the buffer
164 may be brought fairly close, if not adjacent to, the
breakable line of securement 120. An additional glass
buffer (not shown) may also be employed adjacent the first
outer surface 110 of the first sheet 102.
The sheets are then translated to another station to
permanently seal the first and third sheets about their
peripheries and to seal at least a portion of the
periphery of the second sheet. Typically, and as shown in
Fig. 18, the second sheet 104 is provided from roll stock
lZ~ 47
-27-
of the same thickness as the first and third sheets 102,
104. However, as shown later in Fig. 19, the second sheet
may be narrower, thus not extending the entire length of
the finished container. However, taking the most typical
case utilizing the full width second sheet, the peripheral
seals 138, 140 between the first and second sheets and the
second and third sheets, respectively, are formed. These
seals may be made in a typical known manner utilizing heat
and pressure, the pressure perhaps approaching 500 p6i, as
Rtated earlier. Typically, the container is cut away from
the supply material along the outer boarders of the
peripheral seals 138, 140. This may be performed during
the same step as forming the peripheral seals.
In the preferred embodiment, the peripheries of the
sheets are sealed except for openings into the first and
second chambers. These openings are used to both fill the
first and second chambers 124, 128 with the components
126, 130. Also, port means such a~ a tubular port
assembly 122 may be inserted through the openings about
which standard heat seals may be made to close both the
chambers and form the finished product.
The finished container 100 is thus formed which,
depending upon he respective materials and laminate
structures of the first, second and third sheets, provides
sterility, moisture and vapor barriers both between the
first and second chambers and between the container and
the environment. These qualities are all crucial when
employing medical substances in the two chambers. The
container is thus capable of maintaining the components
126, 130 in sterile condition.
Referring once more to Fig. 19, there i8 shown an
alternate embodiment of the container 166. The container
166 may be substantially identical to the container 100,
utilizing first and third sheets 168 and 172 and including
lZ~47
-28-
a breakable line of securement 174 and a permanent line of
securement 176. A tubular port assembly 178 may also be
provided. Here, however, the second, diaphragm sheet 170
does not extend the full length of the container 166 from
the administration port end 180 to the hanger end 182.
Instead, the roll stock for the second sheet and thus the
second sheet itself is wide enough to provide breakable
and permanent lines of securement 174, 176 which may be
identical to the breakable and permanent lines of secure-
ment 120, 132.
Such a configuration is not as desirable as the con-
tainer 100 previously described because the components
stored in the container may be disposed on both the inner
and outer surfaces 184, 186 of the second sheet of both
1~ the first and second chambers 188, 190. This is true both
before and after separation of the breakable line 174 and
mixing of the components.
Referring now to Figs. 21 and 22, there is illustrated
a further alternate container 192. The container 192 may
be identical to the container 100 except that there are a
plurality of both breakable and permanent lines of secure-
ment.
The container 192 includes first, second and third
sheets 194, 196 and 198. Although the breakable lines of
securement 200, 202 may include various types of selec-
tively breakable lines, the breakable lines of securement
200, 202 are illustrated in Figs. 21 and 22 and will be
described hereafter as embodying the unique seal line such
as designated above as seal line 34, having cross-
sectional seals 204, 206, respectively, which are the same
as both previously designated seals 36 and 136. A
plurality of permanent lines of securement 208, 210 are
provided which are substantially coextensive with and
~24(~6~7
-29-
parallel to the respective breakable lines of securement
200, 20~.
The container 192 includes a first chamber 212, a
second chamber 214 and a third chamber 216. Here, the
third chamber 216 is defined in part by the first and
second sheets 194, 196 as is the first chamber 212. The
second chamber 214 is defined in part by the second and
third sheets 196, 198.
The first chamber 212 is defined by the second,
diaphragm sheet 196, the openable seal line 202, the first
sheet 194 and the permanent line of securement 210. The
third chamber 216 is defined by the second sheet 196, the
openable seal line 200, the first sheet 194 and the
permanent seal line 208.
The second chamber 214 is defined by the second sheet
196, the third sheet 198, both openable seal lines 200,
202 and both permanent seal lines 208, 210.
As shown in Figs. 21 and 22, the second chamber 214
serves as a buffer. Although there is room for storage,
it is not intended that any component be stored in the
second chamber 214. The container 192 includes first and
second common portions 196A, 196B of the second sheet
196. The container 192 thus segregates components 218,
220 which may be stored in the first and third chambers
212, 216 to an even greater extent that the segregation of
the two components in the container 100.
Mixing of the components 218, 220 is affected in the
same manner as with the container 100. The first and
third sheets 194, 198 are pulled apart near the lines of
~ecurement 200, 202, 208, 210, thus rupturing the second
sheet 196 at the break lines 222 and 224. Upon rupture of
the second sheet 196 at the break lines 222, 224, the
first, second and third chambers are placed in open
communication. With the breakable lines of securement
lZ~647
-30-
, 200, 202 ~panning virtually the entire width of the con-
tainer 192, a homogenous mixture of the components 218,
220 may be obtained almost immediately.
Referring now to Fig. 20, there is shown a container
226 including first, second and third chambers 228, 230,
232 for the storage of first component 234, second
component 236 and third component 238, respectively. The
container 226 includes first, second and third sheets 240,
242, 244 as with containers 100, 192.
The first and sec~nd chambers 228, 230 are separated
in the Qame manner as the first and third chambers 212,
216 in the container 192. The first and second chambers
228, 230 are separated by two breakable lines of secure-
ment 246, 248 and two permanent lines of securement 250,
252, thereby creating a fourth, barrier or buffer chamber
254 like the second, buffer chamber 214 in the container
192.
Similarly, the second and third chambers 230, 232 are
separated by two breakable lines of securement 256, 258
and two permanent lines of securement 260, 262, defining a
fifth barrier chamber 264.
Although the container 226 utilizes the double barrier
configuration between component containing chambers as
with the container 192, the three component container 226
may be constructed with single breakable and permanent
lines of securement between chambers 228 and 230 and
between chambers 230 and 232. However, the double barrier
configuration which includes the fourth and fifth barrier
or buffer chambers 254, 264, creates an extra assurance
that there will be no transfer of one component from
chamber to chamber during storage.
The barrier chambers, such as the chamber 214 in the
container 192 and the chambers 254, 264 in the container
226 serve an additional, important function. These
~Z~6~7
-31-
barrier chambers provide a visual test that no moisture
transmission has occurred between the component containing
chambers. By inspecting the barrier chambers immediately
before mixing, the nurse or other operator can detect
moisture in the barrier chambers. If moisture is found,
the operator may dispose of the container because of the
possibility of moisture transmission between component
containing chambers. Only the portion of the first and
third sheets about the lines of securement need be trans-
parent in order to utilize this test procedure. However,
even if not used as a test of moisture transmission, the
barrier chambers provide added assurance that each
component-containing chamber is secure.
The container 226 illustrated in Fig. 20, as well as
the container 192 of Figs. 21 and 22 may be manufactured
in the same manner as shown in Fig. 18. Port means such
as tubular port assemblies 266A, 266B, 266C may be pro-
vided to fill and/or provide access to each of the three
chambers.
As discussed above, laminate structures employing
virtually absolute moisture, air and sterility barriers,
such as SARAN and foil, may be used when medical sub-
stances are stored in the containers. However, when
laminate structures are used, the chances of maintaining a
transparent or translucent sheet is decreased, both
becau~e of the greater variety of material used, e.g.,
foil, and due to the fact that there are various layers in
the structure. It may, however, be desirable to visually
in~pect the contents of each chamber before mixing to
assure the operator that the container contents are in
good condition. This may be especially important when the
container is used to store medical substances. It may be
particularly desirable to inspect a chamber containing a
dry powdered drug for the presence of any moisture what-
lZ~4~
-32-
soever or, as a further example, a chamber containing
amino acids, which is a superior growth medium.
A solution to this problem is illustrated in Figs.
23-26. The container 268 shown in Fig. 24 includes first
and third sheets 270, 274 and a second, diaphragm sheet
272. A tubular port assembly 276 communicates with the
second chamber 280. The first chamber 278 and second
chamber 280 are separated by a breakable line of secure-
ment 282 and a permanent line of securement 284. The
breakable line of securement 282 may be the unique seal
line 34.
As an example, the first component 286 stored in the
first chamber 278 may be a powdered drug and the second
component 288 stored in the second chamber 280 may be a
saline solution. In order to prevent moisture trans-
mission from the second chamber 280 to the first chamber
278 and to minimize moisture and vapor transmission
between the first and second chambers and the environment,
the first and second sheets 270, 272 may be laminate
structures including, for example, inner and outer
surfaces of polyvinyl chloride and a middle layer of
aluminum foil. In order to permit visual inspection of
the container contents, the third sheet 274 may be trans-
parent or translucent such as if made solely from a
polyvinyl chloride formulation.
Over time, minute amounts of gas and moisture trans-
mission may occur between the saline solution in the
second chamber 280 and the environment, in such small
amounts as to still be permissible under good medical
3~ procedure. However, the transmis~ion of small amounts of
moisture into the powder drug containing chamber 278 is
not permissible. The container 268 therefore includes a
peelable barrier segment 290 which may include an outer
layer of aluminum foil 292 and an inner adhesive layer
12~6~7
294. The peelable barrier segment 290 is secured with the
inner adhesive layer 294 to that portion of the third
sheet 274 forming the exterior wall of the first chamber
278. Preferably, the peelable barrier segment 290 also
extends over the breakable and permanent lines of secure-
ment 282, 284.
Before breaking the breakable line of securement 282
to mix the container contents, the nurse or other operator
may simply peel away a portion or all of the peelable
barrier segment 290 to inspect the p~wdered drug 2~6
through the third sheet 274.
Fig. 25 shows a cutaway view of the container 268,
schematically illustrating the placement of the peelable
barrier segment 290 over the third sheet 274.
Fig. 26 illustrates a container 296 which is an
alternate embodiment of the container 268. The container
296 includes first, second and third sheets 302, 304 and
306, respectively. Fig. 26 schematically illustrates the
placement of first and second peelable barrier segments
298, 300. The second peelable barrier segment 300 is,
like the peelable barrier segment 290 of container 268,
placed over that portion of the third sheet 306 which
forms an exterior wall of the first chamber 308. The
first peelable barrier segment 298 is placed over that
portion of the first sheet 302 which is coextensive with
that portion of the second sheet 304 forming the opposite
wall of the first chamber 308. The container 296 may
include a dry powdered drug as the first component (not
shown) stored in the first chamber 308. The second
chamber 310 may include a saline solution as the second
component (not shown). The container 296 may also include
the breakable and permanent lines of securement 312, 314.
The embodiment shown in the container 296 may permit the
use of relatively inexpensive materials such as polyvinyl
lZ~Q647
-34-
chloride, for all three sheets, without the need for
laminate structures. The peelable barrier segments 298,
300 will prevent any moisture or vapor transmission
between the environment and the first chamber 308. The
only area through which moisture may pass into the first
chamber 308 is at the common portion 304C of the second,
diaphragm sheet 304. Moisture transmission from the
second chamber into the first chamber across the common
portion 304C would only occur if the second sheet 304 did
1o not include the proper barrier material. When the rela-
tively inexpensive straight PVC is used for the second
diaphragm sheet, this moisture transmission across a
common portion 304C may be minimized by utilizing the
double barrier construction including multiple breakable
and permanent lines and a middle barrier or "no man's
land" chamber such as the chambers 214, 254, 264 of the
containers 192, 226. Also, there may be applications
where the single barrier illustrated in Fig. 26 with a
common portion 304C is permissiblP in conjunction with the
peelable barrier segments 298, 300 such as where the first
component must'be maintained very dry but not absolutely
dry or where the storage time is relatively short,
minimizing any transmission problems across the common
portion 304C.
High barrier property materials in higher cost
laminate structures for the first and third sheets of the
containers 100, 166, 192, 226, 268, 296 may be eliminated
and substituted with the relatively lower cost materials
such as one layer PVC or EVA, even when medical substances
such as powdered drugs are stored therein, and no peelable
barrier segments need be used, if the entire container is
packaged in a gas and moisture barrier overpouch. How-
ever, the use of the proper laminate structures as dis-
cussed above, and the use of a peelable barrier segment
lZ~ 7
either in conjunction with or in substitution of the
laminate structures, may totally eliminate the need for a
moisture barrier overpouch, thus substantially reducing
product cost while maintaining a high quality container
suitable for even medical use.
The containers 100, 166, 192, 226, 268, 296 may all be
used as a primary solution container for direct connection
to a parenteral administration set. Stated differently,
each of these containers may, after mixing of the
components stored therein, be placed on an IV stand at a
patient's bedside for direct infusion into the patient's
venous system.
While several embodiments and features have been
described in detail herein and shown in the accompanying
drawings, it will be evident that various further modifi-
cations are possible without departing from the scope of
the invention.
