U.S. patent application number 12/341661 was filed with the patent office on 2009-07-02 for multi-chambered containers.
This patent application is currently assigned to BAXTER INTERNATIONAL INC.. Invention is credited to Patrick Balteau.
Application Number | 20090166363 12/341661 |
Document ID | / |
Family ID | 40456379 |
Filed Date | 2009-07-02 |
United States Patent
Application |
20090166363 |
Kind Code |
A1 |
Balteau; Patrick |
July 2, 2009 |
MULTI-CHAMBERED CONTAINERS
Abstract
Multi-chambered containers having individually arranged chambers
and methods of using same are provided. In a general embodiment,
the present disclosure provides a multi-chambered container
including a first chamber, a second chamber, and a third chamber. A
first peelable seal separates the first and third chambers. The
first peelable seal is independently openable by selective
application of external pressure to the first chamber. A second
peelable seal separates the second and third chambers. The second
peelable seal is independently openable by selective application of
external pressure to the second chamber. The first chamber is
separated from the second chamber by a permanent seal defining a
transverse opening.
Inventors: |
Balteau; Patrick; (Evelette,
BE) |
Correspondence
Address: |
BAXTER HEALTHCARE CORPORATION
1 BAXTER PARKWAY, DF2-2E
DEERFIELD
IL
60015
US
|
Assignee: |
BAXTER INTERNATIONAL INC.
Deerfield
IL
BAXTER HEALTHCARE S.A.
Zurich
|
Family ID: |
40456379 |
Appl. No.: |
12/341661 |
Filed: |
December 22, 2008 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61017094 |
Dec 27, 2007 |
|
|
|
Current U.S.
Class: |
220/523 |
Current CPC
Class: |
A61J 1/2093 20130101;
A61M 1/1668 20140204; A61M 1/287 20130101; A61J 1/2024 20150501;
A61J 1/10 20130101 |
Class at
Publication: |
220/523 |
International
Class: |
B65D 1/36 20060101
B65D001/36 |
Claims
1. A container comprising: a first chamber, a second chamber, and a
third chamber; a first peelable seal separating the first and third
chambers, the first peelable seal being independently openable by
selective application of external pressure to the first chamber;
and a second peelable seal separating the second and third
chambers, the second peelable seal being independently openable by
selective application of external pressure to the second chamber,
wherein the first chamber is separated from the second chamber by a
permanent seal defining a transverse opening.
2. The container of claim 1, wherein at least one of the first
chamber and second chamber is dimensioned to facilitate one-handed
gripping of the chamber to apply the external pressure.
3. The container of claim 1, wherein the transverse opening is
dimensioned to admit a human hand to apply the external
pressure.
4. The container of claim 1, wherein the third chamber contains a
parenterally administrable base solution.
5. The container of claim 1, wherein the third chamber is empty and
is sized to contain the entire contents of the first chamber and
the second chamber.
6. The container of claim 1, wherein the container is made from a
film comprising at least one material selected from the group
consisting of polyolefins, polyamides, polyesters, polybutadiene,
styrene and hydrocarbon copolymers, polyimides,
polyester-polyethers, polyamide-polyethers, and combinations
thereof.
7. The container of claim 1, wherein the film comprises at least
one material selected from the group consisting of polyethylene
homopolymers, ethylene .alpha.-olefin copolymers, polyethylene
copolymers, polypropylene homopolymers, polypropylene copolymers,
styrene and hydrocarbon random copolymers, styrene and hydrocarbon
block copolymers, and combinations thereof.
8. The container of claim 1, wherein the first peelable seal and
the second peelable seal are activated by a force ranging from
about 3 N/15 mm to about 30 N/15 mm.
9. The container of claim 1, wherein the first peelable seal has a
first activating force and the second peelable seal has a second
activating force, the second peelable seal activating force is
greater than the first peelable seal activating force.
10. The container of claim 9, wherein the difference between the
first peelable seal activating force and the second peelable seal
activating force is greater than about 1 N/15 mm and less than
about 5 N/15 mm.
11. The container of claim 1, wherein at least a portion of the
first peelable seal and the second peelable seal comprises a shape
selected from the group consisting of semicircular, rectangular,
trapezoidal, polygonal, and combinations thereof.
12. The container of claim 1, wherein the first chamber and the
second chamber contain components of a peritoneal dialysis
solution.
13. The container of claim 1, wherein the first chamber and the
second chamber contain components of a parenteral nutrition
solution.
14. The container of claim 1 further comprising a fluid outlet port
in fluid communication with the third chamber.
15. The container of claim 14 further comprising a peelable safety
seal separating the outlet port from the third chamber, wherein the
safety seal has a seal strength selected to impede opening of the
safety seal unless at least one of the first and second peelable
seals have first been opened.
16. The container of claim 1 further comprising a tube in fluid
communication with at least one of the first chamber and the second
chamber.
17. A multi-chambered container comprising: at least two plies of a
flexible polymer film defining a first chamber, a second chamber,
and a third chamber formed between the plies; a first peelable seal
separating the first and third chambers, the first peelable seal
being independently openable by selective application of external
pressure to the first chamber; and a second peelable seal
separating the second and third chambers, the second peelable seal
being independently openable by selective application of external
pressure to the third chamber, wherein the first and third chambers
are separated by a permanent seal defining a transverse opening
through the plies.
18. The multi-chambered container of claim 17, wherein at least one
of the first chamber and second chamber is dimensioned to
facilitate one-handed gripping of the chamber to apply the external
pressure.
19. The multi-chambered container of claim 17, wherein the
transverse opening is dimensioned to admit a human hand to apply
the external pressure.
20. A multi-chambered container comprising: at least two plies of a
flexible polymer film defining a first chamber, a second chamber, a
third chamber, and a fourth chamber formed between the plies; a
first peelable seal separating the first and fourth chambers, the
first peelable seal being independently openable by selective
application of external pressure to the first chamber; a second
peelable seal separating the second and fourth chambers, the second
peelable seal being independently openable by selective application
of external pressure to the second chamber; and a third peelable
seal separating the third and fourth chambers, the third peelable
seal being independently openable by selective application of
external pressure to the third chamber, wherein the first chamber
is separated from the second chamber by a first permanent seal
defining a transverse opening through the plies and the second
chamber is separated from the third chamber by a second permanent
seal defining a transverse opening through the plies.
21. The multi-chambered container of claim 20, wherein at least one
of the first chamber, second chambers and the third chamber is
dimensioned to facilitate one-handed gripping of the chamber to
apply the external pressure.
22. The multi-chambered container of claim 20, wherein the
transverse opening is dimensioned to admit a human hand to apply
the external pressure.
23. The multi-chambered container of claim 20, wherein the fourth
chamber is sized to facilitate mixing of the contents of any
combination of the first, second, and third chambers.
24. The multi-chambered container of claim 20 further comprising a
fluid outlet port in fluid communication with the fourth
chamber.
25. The multi-chambered container of claim 24 further comprising a
peelable safety seal separating the outlet port from the fourth
chamber, wherein the safety seal has a seal strength selected to
impede opening of the safety seal unless at least one of the first,
second, and third peelable seals have first been opened.
26. The multi-chambered container of claim 20 further comprising a
tube in fluid communication with at least one of the first chamber,
the second chamber, and the third chamber.
27. A method of administering a product, the method comprising:
providing a container comprising: a first chamber comprising a
first component, a second chamber comprising a second component,
and a third chamber, a first peelable seal separating the first and
third chambers, the first peelable seal being independently
openable by selective application of external pressure to the first
chamber, and a second peelable seal separating the second and third
chambers, the second peelable seal being independently openable by
selective application of external pressure to the second chamber,
wherein the first chamber is separated from the second chamber by a
permanent seal defining a transverse opening; and compressing at
least one of the first chamber and the second chamber to allow the
component from the compressed chamber to flow through into the
third chamber.
28. The method of claim 27, wherein the squeezing is performed by a
user's hand squeezing the chamber.
29. The method of claim 27 further comprising compressing a
remaining chamber to allow the component from the compressed
chamber to flow through into the third chamber to form a mixed
component.
30. The method of claim 29 further comprising administering the
mixed component through a fluid outlet port in fluid communication
with the third chamber.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Patent Application Ser. No. 61/017,094 filed on Dec. 27, 2007, the
entire disclosure of which is hereby incorporated by reference.
BACKGROUND
[0002] The present disclosure is directed to packaging products.
More specifically, the present disclosure is directed to
multi-chambered containers for the selective admixture of
solutions.
[0003] Containers having sub-chambers are widely used to separately
store two or more components. The components can be mixed inside
the container and administered to a patient through a tube attached
to the container. The components can be in a powder or liquid form
and are typically mixed together to form a therapeutic solution.
Such solutions can include intravenous solutions, nutritional
solutions, drug solutions, enteral solutions, parenteral solutions,
dialysis solutions, pharmacological agents including gene therapy
and chemotherapy agents, and many other liquids that may be
administered to a patient.
[0004] The storage chambers of the multi-chambered containers are
often separated by a frangible heat seal. Peelable seals are among
the frangible seals used that permit the seal to be separated by
pulling on opposite sides of the container to mix the contents of
the separated chambers. Nevertheless, multi-chambered containers
are currently designed so that once the peel seal between chambers
is broken, the entire contents from each chamber mixes together. As
a result, these multi-chambered containers provide little control
over the selective mixture of components in the storage
chambers.
SUMMARY
[0005] The present disclosure is directed to multi-chambered
containers that can be used for the selective admixture of
components within the chambers. In a general embodiment, the
present disclosure provides a multi-chambered container including a
first chamber, a second chamber, and a third chamber. A first
peelable seal separates the first and third chambers and is
independently openable by selective application of external
pressure to the first chamber. A second peelable seal separates the
second and third chambers and is independently openable by
selective application of external pressure to the second chamber.
The first chamber is separated from the second chamber by a
permanent seal defining a transverse opening. At least one of the
first chamber and second chamber is dimensioned to facilitate
one-handed gripping of the chamber to apply the external pressure.
For example, the transverse opening can be dimensioned to admit a
human hand to apply the external pressure.
[0006] In an embodiment, the third chamber can contain a
parenterally administrable base solution. In another embodiment,
the third chamber can be empty and sized to contain the entire
contents of the first chamber and the second chamber.
[0007] In an embodiment, the container is made from a film
including one more materials such as, for example, polyolefins,
polyamides, polyesters, polybutadiene, styrene and hydrocarbon
copolymers, polyimides, polyester-polyethers, polyamide-polyethers,
or a combination thereof. More specifically, the film can include
one or more materials such as, for example, polyethylene
homopolymers, ethylene .alpha.-olefin copolymers, polyethylene
copolymers, polypropylene homopolymers, polypropylene copolymers,
styrene and hydrocarbon random copolymers, styrene and hydrocarbon
block copolymers, or a combination thereof.
[0008] In an embodiment, the first peelable seal and the second
peelable seal are activated by a force ranging from about 3 N/15 mm
to about 30 N/15 mm. In addition, the first peelable seal can have
a first activating force and-the second peelable seal can have a
second activating force. The second peelable seal activating force
can be greater than the first peelable seal activating force. The
difference between the first peelable seal activating force and the
second peelable seal activating force can be greater than about 1
N/15 mm and less than about 5 N/15 mm.
[0009] In an embodiment, at least a portion of the first peelable
seal and the second peelable seal has a shape such as semicircular,
rectangular, trapezoidal, polygonal, or a combination thereof.
[0010] In an embodiment, the first chamber and the second chamber
contain components of a peritoneal dialysis solution.
Alternatively, the first chamber and the second chamber can contain
components of a parenteral nutrition solution.
[0011] In an embodiment, the multi-chambered container further
includes a fluid outlet port in fluid communication with the third
chamber. A peelable safety seal can separate the outlet port from
the third chamber. The safety seal can have a seal strength
selected to impede opening of the safety seal unless at least one
of the first and second peelable seals have first been opened. The
multi-chambered container can further include a tube in fluid
communication with at least; one of the first chamber and the
second chamber.
[0012] In another embodiment, the present disclosure provides a
multi-chambered container including at least two plies of a
flexible polymer film defining a first chamber, a second chamber,
and a third chamber formed between the plies. A first peelable seal
separates the first and third chambers and is independently
openable by selective application of external pressure to the first
chamber. A second peelable seal separates the second and third
chambers and is independently openable by selective application of
external pressure to the third chamber. The first and third
chambers are separated by a permanent seal defining a transverse
opening through the plies.
[0013] In an alternative embodiment, the present disclosure
provides a multi-chambered container including at least two plies
of a flexible polymer film defining a first chamber, a second
chamber, a third chamber, and a fourth chamber formed between the
plies. A first peelable seal separates the first and fourth
chambers and is independently openable by selective application of
external pressure to the first chamber. A second peelable seal
separates the second and fourth chambers and is independently
openable by selective application of external pressure to the
second chamber. A third peelable seal separates the third and
fourth chambers and is independently openable by selective
application of external pressure to the third chamber. The first
chamber is separated from the second chamber and the second chamber
is separated from the third chamber by a permanent seal defining a
transverse opening through the plies. At least one of the first
chamber, second chamber, and the third chamber is dimensioned to
facilitate one-handed gripping of the chamber to apply the external
pressure. For example, the transverse opening can be dimensioned to
admit a human hand to apply the external pressure.
[0014] In an embodiment, the fourth chamber is sized to facilitate
mixing of the contents of any combination of the first, second, and
third chambers. The multi-chambered container can further include a
fluid outlet port in fluid communication with the fourth chamber. A
peelable safety seal can separate the outlet port from the fourth
chamber. The safety seal can have a seal strength selected to
impede opening of the safety seal unless at least one of the first,
second, and third peelable seals have first been opened. The
container can also include one or more tubes in fluid communication
with at least one of the first chamber, the second chamber, and the
third chamber.
[0015] In yet another embodiment, the present disclosure provides a
method of administering a product. The method comprises providing a
container including a first chamber having a first component, a
second chamber having a second component, and a third chamber. The
container is constructed and arranged according to embodiments of
the present disclosure. The method further comprises compressing at
least one of the first chamber and the second chamber to allow the
component from the corresponding compressed chamber to flow through
into the third chamber. The squeezing can be performed by a user's
hand squeezing the specific chamber.
[0016] The method can further comprise compressing the remaining
chamber to allow the component from the remaining compressed
chamber to flow through into the third chamber to form a mixed
component. The components from the first and second chambers can be
mixed in the third chamber and administered through a fluid outlet
port in fluid communication with the third chamber to a
patient.
[0017] An advantage of the present disclosure is to provide an
improved multi-chambered container have the capability for
selectively administering the individual contents from specific
chambers of the container.
[0018] Another advantage of the present disclosure is to provide an
improved multi-chambered container that allows the reconstitution
of custom tailored solutions.
[0019] Yet another advantage of the present disclosure is to
provide a method of custom administering components of a
multi-chambered container.
[0020] Additional features and advantages are described herein, and
will be apparent from the following Detailed Description and the
figures.
BRIEF DESCRIPTION OF THE FIGURES
[0021] FIG. 1 illustrates a front view of the multi-chambered
container including two chambers that lead into a mixing chamber in
an embodiment of the present disclosure.
[0022] FIG. 2 illustrates a front view of the multi-chambered
container including three chambers that lead into a mixing chamber
in another embodiment of the present disclosure.
DETAILED DESCRIPTION
[0023] The present disclosure relates to multi-chambered containers
having individually arranged storage chambers. In alternative
embodiments, the multi-chambered containers allow an operator/user
to selectively mix a specific amount of one or more components
(e.g. solutions/concentrates) from each storage chamber into a
holding/mixing chamber situated below the storage chambers
containing the components. The holding/mixing chamber could be
either empty at start of the mixing or be filled with a base
solution that could potentially be infused as is (alone) to a
patient. The mixing of the components contained in the storage
chambers can be performed by sequentially applying a specific
amount of pressure on each of the individual storage chambers
containing the specific components.
[0024] In a general embodiment shown in FIG. 1, the present
disclosure provides a container 10 including a body 12 defined by a
film. The container 10 includes a first chamber 30, a second
chamber 40, and a third chamber 50. The container 10 may be made,
for example, from two plies of the film that are sealed about the
periphery of the container 10 at edges 14, 16, 18, and 20 to form
outer permanent (cohesive) seals. In the illustrated embodiment,
two plies of film (one for each side) are used although additional
plies of film can be used. The size and dimensions of the container
10 and chambers 30, 40, and 50 can vary depending on the
application.
[0025] A first peelable (adhesive) seal 32 separates the first
chamber 30 and the third chamber 50. The first peelable seal 32 is
independently openable by selective application of external
pressure to the first chamber 30. A second peelable seal 42
separates the second chamber 40 and the third chamber 50. The
second peelable seal 42 is independently openable by selective
application of external pressure to the second chamber 40.
Accordingly, the component stored in the first chamber 30 can be
added to chamber 50 separately from the component stored in the
second chamber 40 and vice versa. Moreover, the amount of pressure
separately applied to the first and second chambers 30 and 40 can
control how much component is removed from the chambers.
[0026] The first chamber 30 is separated from the second chamber 40
by a permanent seal 52 defining a transverse opening 54. As a
result, the first chamber 30 and/or the second chamber 40 can be
dimensioned to facilitate one-handed gripping of the chambers 30
and 40 to apply the external pressure. For example, the transverse
opening 54 positioned between the individual chambers 30 and 40
allows for a pressure to be applied on any one of the individual
chambers 30 or 40 without exerting pressure on the other
chambers.
[0027] By pressurizing, one at a time, a specific chamber (30 or
40) containing one or more components to be mixed together to
satisfy the specific needs of a given patient, a user or care giver
can prepare a mixed formulation having specified or selective
amounts from the individually stored components of chambers 30 and
40. The chambers 30 and 40 can be marked with unit markings (e.g.
showing volume remaining) to inform the user how much of the
component has been removed from that chamber. The selective amount
of the stored components can be thoroughly mixed in the third
chamber 50 prior to being infused or administered to the
patient.
[0028] The first peelable seal 32 and the second peelable seal 42
can be constructed and arranged to allow a precise amount of
component to pass through between chambers. For example, a
specified portion of the peelable seals 32 and 42 can open that
corresponds to the amount of pressure or force applied to the
chambers 30 and 40, respectively. In addition, the first peelable
seal 32 and the second peelable seal 42 can be in the form of
re-peelable/re-sealable seals that can be closed after a specified
amount of component has been squeezed from their respective
chambers into the third chamber 50.
[0029] In an embodiment, the transverse opening 54 has a width
(side to side) greater than 5 mm. The transverse opening 54 can
also have a larger width such as, for example, a width greater than
6 mm, greater than 7 mm, greater than 8 mm, greater than 9 mm,
greater than 10 mm, and the like. In another embodiment, the
transverse opening 54 has a length (top to bottom) greater than 5
cm. The transverse opening 54 can also have a larger length such
as, for example, a width greater than 6 cm, greater than 7 cm,
greater than 8 cm, greater than 9 cm, greater than 10 cm, greater
than 11 cm, greater than 12 cm, greater than 13 cm, greater than 14
cm, greater than 15 cm, greater than 16 cm, greater than 17 cm,
greater than 18 cm, greater than 19 cm, greater than 20 cm, and the
like. For example, the transverse opening 54 can be dimensioned to
admit a human hand 70 (e.g. adult/care giver) to apply the external
pressure.
[0030] The first chamber 30 and the second chamber 40 can be
storage chambers for holding one or more components such as a
solution or concentrate. The third chamber 50 can be a
holding/mixing chamber. For example, the components or solutions
stored in chambers 30 and 40 can provide a reconstituted
therapeutic solution when mixed together in chamber 50 prior to
usage. Alternatively, the third chamber 50 can be pre-filled with a
base solution that could be infused alone or in combination with
one or more of the solutions/concentrates contained in the first
chamber 30 and/or the second chamber 40, which can be selectively
put in fluid communication with the third chamber 50. Such
solutions can include intravenous solutions, nutritional solutions,
drug solutions, enteral solutions, parenteral solutions, dialysis
solutions, and many other liquids that may be administered to a
patient.
[0031] In an embodiment, the first peelable seal 32 and the second
peelable seal 42 can be activated by a force ranging from about 3
N/15 mm to about 30 N/15 mm. The force can be applied, for example,
from a user squeezing sides of the container 10 so that the
components stored within chambers 30 or 40 press against the first
peelable seal 32 and the second peelable seal 42, respectively.
[0032] In another embodiment, the first peelable seal 32 has a
first activating force (e.g. amount of force necessary to open the
seal) and the second peelable seal 42 has a second activating
force. The second peelable seal activating force is greater than
the first peelable seal activating force. The difference between
the first peelable seal activating force and the second peelable
seal activating force can be greater than about 1 N/15 mm and less
than about 5 N/15 mm.
[0033] The peelable seals 32 and 42 can have any suitable shape.
For example, as illustrated in FIG. 1, the peelable seals 32 and 42
can be in the form of semi-circular seals having an apex that is
oriented towards the inside of the individual chambers 30 and 40,
respectively. In an embodiment, at least a portion of the peelable
seals 32 and 42 has a shape such as semicircular, rectangular,
trapezoidal, polygonal, or combinations thereof. The peelable seals
32 and 42 can also be serrated to facilitate their opening upon
application of a pressure on the corresponding chamber.
[0034] As illustrated in FIG. 1, the container 10 can further
include an administration tube 60 and a medication tube 67 in fluid
communication with the third chamber 50. Medication tube 67
provides communication with the interior of chamber 50 and is
equipped with a seal such as septum 69 that allows components such
as a liquid to be added to or removed from the multi-chambered
container, for example, after the contents of chambers 30 and 40
have been mixed. The tube 60 can also include a membrane (not
shown) that seals shut the tube 60 and can be pierced by, for
example, a cannula or spike of an administration set. The tube 60
can be sealed until the time to access the contents of the
container 10.
[0035] A peelable safety seal 62 can surround an opening of the
tube 60. The safety seal 62 can have a seal strength selected to
impede opening of the safety seal 62 unless at least one of the
first and second peelable seals 32 and 42 have first been opened.
The peelable safety seal 62 can have any suitable shape.
[0036] In an embodiment, the container 10 can further include one
or more tubes 64 in fluid communication with the first chamber 30
and/or the second chamber 40. The tubes 64 can provide
communication with the interior of chambers 30 and 40 and allow
components such as solutions/concentrates to be added to or removed
from chambers 30 and 40. For example, the tubes 64 can be used as
fill ports for chambers 30 and 40 or as additive ports to allow
addition of a medication or other additive to one of the chambers
after the chamber has been filled and sealed. The tubes 64 can be
capped or sealed after the chambers 30 and 40 have been filled with
the desired components. The number, size, and dimensions of the
filling tubes 64, medication tube 67, and administration tube 60
can vary depending on the application.
[0037] The container 10 and the peelable seals 32 and 42 can be
constructed from films able to make peal seal layers in accordance
with embodiments of the present disclosure. The peelable seal layer
films can allow both peelable and permanent seals to be created.
Thus, the permanent side seals 14, 16, 18, and 20 as well as the
peelable seals 32, 42, and 52 can be created from the same layer of
film.
[0038] In the illustrated embodiment, any portion of the container
10 can be made from one or more suitable polymer materials.
Suitable polymer materials include polyethylene homopolymers,
ethylene .alpha.-olefin copolymers, polyethylene copolymers,
polypropylene homopolymers, polypropylene copolymers, styrene and
hydrocarbon random copolymers, styrene and hydrocarbon block
copolymers, or combinations thereof. More examples of suitable
polymer materials are described below.
[0039] In another embodiment shown in FIG. 2, the present
disclosure provides a multi-chambered container 110 including a
body 112 made of at least two plies of a flexible polymer film
defining a first chamber 130, a second chamber 140, a third chamber
150, and a fourth chamber 160 formed between the plies. The
container 110 may be made from, for example, two or more plies of
the film that are sealed about the periphery of the container 110
at edges 114, 116, 118 and 120.
[0040] A first peelable seal 132 separates the first chamber 130
and the fourth chamber 160. The first peelable seal 132 is
independently openable by selective application of external
pressure to the first chamber 130. A second peelable seal 142
separates the second chamber 140 and the fourth chamber 160, The
second peelable seal 142 is independently openable by selective
application of external pressure to the second chamber 140. A third
peelable seal 152 separates the third chamber 150 and the fourth
chamber 160. The third peelable seal 152 is independently openable
by selective application of external pressure to the third chamber
150.
[0041] The first chamber 130 is separated from the second chamber
140 by a permanent seal 162 defining a transverse opening 164
through the plies. The second chamber 140 is separated from the
third chamber 150 by a permanent seal 166 defining a transverse
opening 168 through the plies. The first chamber 130, second
chamber 140, and the third chamber 150 can be dimensioned to
facilitate one-handed gripping of the chamber to apply the external
pressure.
[0042] In an embodiment, the transverse openings 164 and 168 have a
width (side to side) greater than 5 mm. The transverse openings 164
and 168 can also have a larger width such as, for example, a width
greater than 6 mm, greater than 7 mm, greater than 8 mm, greater
than 9 mm, greater than 10 mm, and the like. In another embodiment,
the openings 164 and 168 have a length (top to bottom) greater than
5 cm. The transverse openings 164 and 168 can also have a larger
length such as, for example, a width greater than 6 cm, greater
than 7 cm, greater than 8 cm, greater than 9 cm, greater than 10
cm, greater than 11 cm, greater than 12 cm, greater than 13 cm,
greater than 14 cm, greater than 15 cm, greater than 16 cm, greater
than 17 cm, greater than 18 cm, greater than 19 cm, greater than 20
cm, and the like. For example, the transverse openings 164 and 168
can be dimensioned to admit a human hand 70 to apply the external
pressure.
[0043] In an embodiment, the fourth chamber 160 is sized to
facilitate mixing of the contents of any combination of the first,
second, and third chambers 130, 140, and 150. The container 110 can
further include a fluid outlet port 170 in fluid communication with
the fourth chamber 160. A peelable safety seal 172 can separate the
outlet port 170 from the fourth chamber 160. The safety seal 172
can have a seal strength selected to impede opening of the safety
seal 172 unless at least one of the first, second, and third
peelable seals 132, 142, and 152 have first been opened.
[0044] The container 110 can also include one or more tubes 174 in
fluid communication with at least one of the first chamber 130, the
second chamber 140, and the third chamber 150. Tubes 174 may
function primarily as fill ports for the chambers 130, 140, and 150
and could be permanently sealed after filling, but may also be
provided with a resealable closure to allow components to be added
to or removed from the corresponding chambers. Similarly, the
container 110 can also include one or more tubes 176 in fluid
communication with chamber 160. Tube 176 can be equipped with a
septum 178 or similar resealable closure so that medications or
other additives may be added to chamber 160 without compromising
the integrity of the container.
[0045] It should be appreciated that multi-chambered containers
having more than 3 storage chambers and/or more than 1 mixing
chamber can be made in accordance with alternative embodiments of
the present disclosure. For example, the multi-chambered containers
can have 4, 5, 6, 7, 8, or more storage chambers in combination
with one or more mixing chambers.
[0046] In yet another embodiment, the present disclosure provides a
method of administering a product such as, for example, a medical
or a pharmaceutical solution. The method comprises providing a
container including a first storage chamber having a first
component, a second storage chamber having a second component, and
a third mixing chamber, The container is constructed and arranged
according to various embodiments of the present disclosure.
[0047] The method further comprises compressing at least one of the
first storage chamber and the second storage chamber to allow a
specified amount of a component from the corresponding compressed
chamber to flow through into the mixing chamber. For example,
continuous squeezing at a certain pressure can open the individual
peelable seals allowing the desired amount of the contents of the
corresponding chamber to flow into the mixing chamber. The
squeezing can be performed by a user's hand squeezing the specific
chamber.
[0048] The method can further comprise compressing the remaining
chamber to allow a specified amount of component from the remaining
compressed chamber to flow through into the mixing chamber to form
a mixed component. The components from the first and second
chambers can be mixed in the third chamber and administered through
a fluid outlet port in fluid communication with the third chamber
to a patient. The peelable seals can be re-closed to prevent the
mixed solution from returning to the storage chambers and/or for
storing any remaining component in the storage chambers.
[0049] The containers in alternative embodiments of the present
disclosure can be fabricated using standard sealing techniques. For
example, the container can be typically formed by placing one or
more polymeric film plies forming the first sidewall and second
sidewall of the container body in registration by their peripheral
portions and sealing their periphery to form a liquid tight pouch
having an outer permanent seal. The polymeric film plies can be
sealed, for example, by heat sealing, radio frequency sealing,
thermal transfer welding, adhesive sealing, solvent bonding, and
ultrasonic or laser welding.
[0050] The peelable seals can be formed prior to, during, or after
forming the permanent seal and can be made using appropriate
sealing techniques such as, for example, heat conduction. The
welding die for the peelable seals may have different temperatures
and shapes along its length and/or edges to achieve the desired
peelable seal configurations.
[0051] Blown extrusion is another method that may be used to make
the pouch. Blown extrusion is a process that provides a moving tube
of extrudate exiting an extrusion die. Air under pressure inflates
the tube. Longitudinal ends of the tube are sealed to form the
pouch. Blown extrusion only requires seals along two peripheral
surfaces, where the single or multiple sheet registration method
requires seals along three or four peripheral surfaces to form the
pouch.
The Sidewall Materials and Layer Structures
[0052] The containers 10 and 110 can be made principally of
flexible polymeric materials, although the container could include
non-polymeric materials such as metal foils without departing from
the disclosure. Numerous polymeric films have been developed for
use in containers. Suitable films may be of a monolayer structure
or a multiple layer structure. The monolayer structure can be made
from a single polymer, or from a polymer blend. The multiple layer
structures can include layers such as a solution contact layer, a
scratch resistant layer, a barrier layer for preventing permeation
of gas (such as carbon dioxide, oxygen or water vapor), tie layers,
or other layers. It is also contemplated to use more than one web
of film for one or both sidewalls. Selection of the appropriate
film depends on the solution or solutions to be contained within
the container. Appropriate polymeric materials are generally
selected from homopolymers and copolymers of polyolefins,
polyamides, polyesters, polybutadiene, styrene and hydrocarbon
copolymers, polyimides, polyester-polyethers, polyamide-polyethers
to name a few.
[0053] The seal layer for a multi-chambered container should
display bi-modal behavior. What is meant by bi-modal behavior is
that the material is capable of forming a permanent seal under one
set of sealing or manufacturing conditions and a peelable seal at a
second set of sealing or manufacturing conditions. The seal layer
can be a homophase polymer, or a matrix-phase polymer system.
Suitable homophase polymers include polyolefins and more preferably
polypropylene and most preferably a propylene and ethylene
copolymer as described in EP 0875231, which is incorporated herein
by reference.
[0054] It is also possible to have a seal layer having container
walls of differing materials that are not compatible with one
another. U.S. patent application Ser. No. 10/351,004, which is
incorporated herein by reference, discloses that containers made
from such incompatible material, in some instances, may not readily
form permanent seals. This problem can be overcome by wrapping a
section of one sidewall over an outside surface of the opposite
sidewall and joined thereto. This method of sealing is disclosed in
U.S. Pat. No. 6,024,220 which is incorporated herein by reference
and made a part hereof.
[0055] Suitable matrix-phase polymer systems will have at least two
components. The two components can be blended together or can be
produced in a two-stage reactor process. Typically, the two
components will have different melting point or glass transition
temperatures. In the case where one of the components is amorphous,
its glass transition temperature will be lower than the melting
point of the other components. Examples of suitable matrix-phase
polymer system includes a component of a homopolymer or copolymer
of a polyolefin and a second component of a styrene and hydrocarbon
copolymer. Another suitable matrix-phase system includes blends of
polyolefins such as polypropylene with polyethylene, or
polypropylene with a high isotactic index (crystalline) with
polypropylene with a lower isotactic index (amorphous), or a
polypropylene homopolymer with a propylene and .alpha.-olefin
copolymer.
[0056] Suitable polyolefins include homopolymers and copolymers
obtained by polymerizing alpha-olefins containing from 2 to 20
carbon atoms, and more preferably from 2 to 10 carbons. Therefore,
suitable polyolefins include polymers and copolymers of propylene,
ethylene, butene-1, pentene-1,4-methyl-1-pentene, hexene-1,
heptene-1, octene-1, nonene-1 and decene-1. Most preferably the
polyolefin is a homopolymer or copolymer of propylene or a
homopolymer or copolymer of polyethylene.
[0057] Suitable homopolymers of polypropylene can have a
stereochemistry of amorphous, isotactic, syndiotactic, atactic,
hemiisotactic or stereoblock. In one preferred form of the
disclosure, the homopolymer of polypropylene is obtained using a
single site catalyst.
[0058] Suitable copolymers of propylene are obtained by
polymerizing a propylene monomer with an .alpha.-olefin having from
2 to 20 carbons. In a more preferred form of the disclosure, the
propylene is copolymerized with ethylene in an amount by weight
from about 1% to about 20%, more preferably from about 1% to about
10% and most preferably from 2% to about 5% by weight of the
copolymer. The propylene and ethylene copolymers may be random or
block copolymers. The propylene copolymer may also be obtained
using a single site catalyst.
[0059] It is also possible to use a blend of polypropylene and
.alpha.-olefin copolymers wherein the propylene copolymers can vary
by the number of carbons in the .alpha.-olefin. For example, the
present disclosure contemplates blends of propylene and
.alpha.-olefin copolymers wherein one copolymer has a 2 carbon
.alpha.-olefin and another copolymer has a 4 carbon .alpha.-olefin.
It is also possible to use any combination of .alpha.-olefins from
2 to 20 carbons and most preferably from 2 to 8 carbons.
Accordingly, the present disclosure contemplates blends of
propylene and .alpha.-olefin copolymers wherein a first and second
.alpha.-olefins have the following combination of carbon numbers: 2
and 6, 2 and 8, 4 and 6, 4 and 8. It is also contemplated using
more than 2 polypropylene and .alpha.-olefin copolymers in the
blend. Suitable polymers can be obtained using a catalloy
procedure. Suitable homopolymers of ethylene include those having a
density of greater than 0.915 g/cc and includes low density
polyethylene (LDPE), medium density polyethylene (MDPE) and high
density polyethylene (HDPE).
[0060] Suitable copolymers of ethylene are obtained by polymerizing
ethylene monomers with an .alpha.-olefin having from 3 to 20
carbons, more preferably 3-10 carbons and most preferably from 4 to
8 carbons. It is also desirable for the copolymers of ethylene to
have a density as measured by ASTM D-792 of less than about 0.915
g/cc and more preferably less than about 0.910 g/cc and even more
preferably less than about 0.900 g/cc. Such polymers are oftentimes
referred to as VLDPE (very low density polyethylene) or ULDPE
(ultra low density polyethylene). Preferably the ethylene
.alpha.-olefin copolymers are produced using a single site catalyst
and even more preferably a metallocene catalyst systems. Single
site catalysts are believed to have a single, sterically and
electronically equivalent catalyst position as opposed to the
Ziegler-Natta type catalysts which are known to have a mixture of
catalysts sites. Such single-site catalyzed ethylene
.alpha.-olefins are sold by Dow under the trade name AFFINITY,
DuPont Dow under the trademark ENGAGE.RTM., Eastman Kodak under the
trade name MXSTEN, and by Exxon under the trade name EXACT. These
copolymers shall sometimes be referred to herein as m-ULDPE.
[0061] Suitable copolymers of ethylene also include ethylene and
lower alkyl acrylate copolymers, ethylene and lower alkyl
substituted alkyl acrylate copolymers and ethylene vinyl acetate
copolymers having a vinyl acetate content of from about 8% to about
40% by weight of the copolymer. The term "lower alkyl acrylates"
refers to comonomers having the formula set forth in Diagram 1:
##STR00001##
[0062] The R group refers to alkyls having from 1 to 17 carbons.
Thus, the term "lower alkyl acrylates" includes but is not limited
to methyl acrylate, ethyl acrylate, butyl acrylate and the
like.
[0063] The term "alkyl substituted alkyl acrylates" refers to
comonomers having the formula set forth in Diagram 2:
##STR00002##
[0064] R.sub.1 and R.sub.2 are alkyls having 1-17 carbons and can
have the same number of carbons or have a different number of
carbons. Thus, the term "alkyl substituted alkyl acrylates"
includes but is not limited to methyl methacrylate, ethyl
methacrylate, methyl ethacrylate, ethyl ethacrylate, butyl
methacrylate, butyl ethacrylate and the like.
[0065] Suitable polybutadienes include the 1,2- and 1,4-addition
products of 1,3-butadiene (these shall collectively be referred to
as polybutadienes). In a more preferred form of the disclosure, the
polymer is a 1,2-addition product of 1,3 butadiene (these shall be
referred to as 1,2 polybutadienes). In an even more preferred form
of the disclosure, the polymer of interest is a syndiotactic
1,2-polybutadiene and even more preferably a low crystallinity,
syndiotactic 1,2 polybutadiene. In a preferred form of the
disclosure, the low crystallinity, syndiotactic 1,2 polybutadiene
will have a crystallinity less than 50%, more preferably less than
about 45%, even more preferably less than about 40%, even more
preferably the crystallinity will be from about 13% to about 40%,
and most preferably from about 15% to about 30%. In a preferred
form of the disclosure, the low crystallinity, syndiotactic 1,2
polybutadiene will have a melting point temperature measured in
accordance with ASTM D 3418 from about 70.degree. C. to about
120.degree. C. Suitable resins include those sold by JSR (Japan
Synthetic Rubber) under the grade designations: JSR RB 810, JSR RB
820, and JSR RB 830.
[0066] Suitable polyesters include polycondensation products of
di-or polycarboxylic acids and di or poly hydroxy alcohols or
alkylene oxides. In a preferred form of the disclosure, the
polyester is a polyester ether. Suitable polyester ethers are
obtained from reacting 1,4 cyclohexane dimethanol, 1,4 cyclohexane
dicarboxylic acid and polytetramethylene glycol ether and shall be
referred to generally as PCCE. Suitable PCCE's are sold by Eastman
under the trade name ECDEL. Suitable polyesters further include
polyester elastomers which are block copolymers of a hard
crystalline segment of polybutylene terephthalate and a second
segment of a soft (amorphous) polyether glycols. Such polyester
elastomers are sold by DuPont Chemical Company under the trade name
HYTREL.RTM..
[0067] Suitable polyamides include those that result from a
ring-opening reaction of lactams having from 4-12 carbons. This
group of polyamides therefore includes nylon 6, nylon 10 and nylon
12. Acceptable polyamides also include aliphatic polyamides
resulting from the condensation reaction of di-amines having a
carbon number within a range of 2-13, aliphatic polyamides
resulting from a condensation reaction of di-acids having a carbon
number within a range of 2-13, polyamides resulting from the
condensation reaction of dimer fatty acids, and amide containing
copolymers. Thus, suitable aliphatic polyamides include, for
example, nylon 6,6, nylon 6,10 and dimer fatty acid polyamides.
[0068] Suitable styrene and hydrocarbon copolymers include styrene
and the various substituted styrenes including alkyl substituted
styrene and halogen substituted styrene. The alkyl group can
contain from 1 to about 6 carbon atoms. Specific examples of
substituted styrenes include alpha-methylstyrene,
beta-methylstyrene, vinyltoluene, 3-methylstyrene, 4-methylstyrene,
4-isopropylstyrene, 2,4-dimethylstyrene, o-chlorostyrene,
p-chlorostyrene, o-bromostyrene, 2-chloro-4-methylstyrene, etc.
Styrene is the most preferred.
[0069] The hydrocarbon portion of the styrene and hydrocarbon
copolymer includes conjugated dienes. Conjugated dienes which may
be utilized are those containing from 4 to about 10 carbon atoms
and more generally, from 4 to 6 carbon atoms. Examples include
1,3-butadiene, 2-methyl-1,3-butadiene (isoprene),
2,3-dimethyl-1,3-butadiene, chloroprene, 1,3-pentadiene,
1,3-hexadiene, etc. Mixtures of these conjugated dienes also may be
used such as mixtures of butadiene and isoprene. The preferred
conjugated dienes are isoprene and 1,3-butadiene.
[0070] The styrene and hydrocarbon copolymers can be block
copolymers including di-block, tri-block, multi-block, star block
and mixtures of the same. Specific examples of di-block copolymers
include styrene-butadiene, styrene-isoprene, and the hydrogenated
derivatives thereof. Examples of tri-block polymers include
styrene-butadiene-styrene, styrene-isoprene-styrene,
alpha-methylstyrene-butadiene-alpha-methylstyrene, and
alpha-methylstyrene-isoprene-alpha-methylstyrene and hydrogenated
derivatives thereof.
[0071] The selective hydrogenation of the above block copolymers
may be carried out by a variety of well known processes including
hydrogenation in the presence of such catalysts as Raney nickel,
noble metals such as platinum, palladium, etc., and soluble
transition metal catalysts. Suitable hydrogenation processes which
can be used are those wherein the diene-containing polymer or
copolymer is dissolved in an inert hydrocarbon diluent such as
cyclohexane and hydrogenated by reaction with hydrogen in the
presence of a soluble hydrogenation catalyst. Such procedures are
described in U.S. Pat. Nos. 3,113,986 and 4,226,952, the
disclosures of which are incorporated herein by reference and made
a part hereof.
[0072] Particularly useful hydrogenated block copolymers are the
hydrogenated block copolymers of styrene-isoprene-styrene, such as
a styrene-(ethylene/propylene)-styrene block polymer. When a
polystyrene-polybutadiene-polystyrene block copolymer is
hydrogenated, the resulting product resembles a regular copolymer
block of ethylene and 1-butene (EB). As noted above, when the
conjugated diene employed is isoprene, the resulting hydrogenated
product resembles a regular copolymer block of ethylene and
propylene (EP). One example of a commercially available selectively
hydrogenated copolymer is KRATON.RTM. G-1652 which is a
hydrogenated SBS tri-block having 30% styrene end blocks and a
mid-block equivalent is a copolymer of ethylene and 1-butene (EB).
This hydrogenated block copolymer is often referred to as SEBS.
Other suitable SEBS or SIS copolymers are sold by Kuraray under the
tradename SEPTON.RTM. and HYBRAR.RTM.. It may also be desirable to
use graft modified styrene and hydrocarbon block copolymers by
grafting an alpha,beta-unsaturated monocarboxylic or dicarboxylic
acid reagent onto the selectively hydrogenated block copolymers
described above.
[0073] The block copolymers of the conjugated diene and the vinyl
aromatic compound are grafted with an alpha, beta-unsaturated
monocarboxylic or dicarboxylic acid reagent. The carboxylic acid
reagents include carboxylic acids per se and their functional
derivatives such as anhydrides, imides, metal salts, esters, etc.,
which are capable of being grafted onto the selectively
hydrogenated block copolymer. The grafted polymer will usually
contain from about 0.1 to about 20%, and preferably from about 0.1
to about 10% by weight based on the total weight of the block
copolymer and the carboxylic acid reagent of the grafted carboxylic
acid. Specific examples of useful monobasic carboxylic acids
include acrylic acid, methacrylic acid, cinnamic acid, crotonic
acid, acrylic anhydride, sodium acrylate, calcium acrylate and
magnesium acrylate, etc. Examples of dicarboxylic acids and useful
derivatives thereof include maleic acid, maleic anhydride, fumaric
acid, mesaconic acid, itaconic acid, citraconic acid, itaconic
anhydride, citraconic anhydride, monomethyl maleate, monosodium
maleate, etc. The styrene and hydrocarbon block copolymer can be
modified with an oil such as the oil modified SEBS sold by the
Shell Chemical Company under the product designation KRATON
G2705.
[0074] The films used in the containers of the present disclosure
can be a multiple layer film having a seal layer, an intermediate
layer, and an external layer. Tie layers may be employed to attach
the seal layer to the intermediate layer and to attach the
intermediate layer to the external layer. In a preferred form of
the disclosure the seal layer is a blend of polypropylene, an
ethylene .alpha.-olefin copolymer and a styrene and hydrocarbon
copolymer. In a more preferred form of the disclosure, the
polypropylene is a polypropylene ethylene copolymer, the ethylene
.alpha.-olefin copolymer is a LLDPE having a density of less than
0.915 g/cc and the styrene and hydrocarbon copolymer is a block
copolymer and preferably a tri-block copolymer of
styrene-ethylene-butylene-styrene or a blend of an SEBS tri-block
with an SEBS di-block as a minor component. The relative
proportions of the components are preferably from about 55% to 75%
of the PP by weight, from 5% to 20% by weight of the LLDPE, and
from 10% to 20%o by weight of the SEBS. The ternary blend of the
seal layer is capable of forming a permanent seal and a peelable
seal at a temperature of from about 123 to 128.degree. C. A
permanent seal is achieved at sealing temperatures above
145.degree. C.
[0075] The intermediate layer may be selected from any of the
polyamides set forth herein and most preferably is a blend of from
about 85 to 98% polyamide 6 and from 2 to 15% polyamide 6I,6T. The
external layer can be selected from polypropylene polymer. For
example, the external layer can be a propylene ethylene copolymer
with an ethylene content of less than 6% by weight of the
copolymer.
[0076] The details of the films are more fully set out in U.S.
patent application Ser. No. 09/439,826, filed Nov. 12, 1999, which
is incorporated in its entirety herein by reference and made a part
hereof.
[0077] Another suitable film can contain three layers: an external
layer, intermediate layer, and seal layer. The external layer can
be a reactor made polypropylene composition having a first
component and a second component. The first component can be a
polypropylene homopolymer and can be present in an amount by weight
of the composition of 40%. The second component can be an
ethylene-propylene rubber (ethylene 20% and propylene 80%) and can
be present in an amount by weight of the composition of 60%.
Suitable products for the external layer are sold by Mitsubishi
Chemical Company under the trade name Zelas 7023. Zelas 7023 is the
subject of U.S. Patent Application Publication No. 2001/0034416 A1
which is incorporated herein by reference in its entirety and made
a part hereof.
[0078] The intermediate layer can be a polymer blend of Zelas 7023
70% by weight and 30% by weight of a random copolymer of styrene
and butadiene that has been hydrogenated. Suitable random
copolymers of styrene and butadiene are sold by JSR under the trade
name Dynaron 2320 P.
[0079] The external layer can be a polymer blend of 60% by weight
Zelas 7023 and 40% by weight of a random copolymer of propylene and
ethylene such as the copolymer sold under the trade name Novatec EG
7C. The films can display bi-modal behavior with peelable seals
being formed at sealing temperatures of about 125.degree. C. and
permanent seals are obtained at about 145.degree. C.
[0080] Other suitable films for this application include those
disclosed in U.S. Pat. Nos. 5,849,843; 5,998,019; 6,083,587;
6,297,046; 5,139,831; 5,577,369; and U.S. Application No.
2003/0077466 A1, which are incorporated herein in their entirety by
reference and made a part hereof.
EXAMPLES
[0081] The multi-chambered containers can contain the following
components in the storage and mixing chambers in alternative
embodiments: [0082] The mixing/holding chamber contains a base
peritoneal dialysis solution. A glucose concentrate is in one of
the storage chambers. Another glucose concentrate is in a second
storage chamber. An amino acid concentrate is in a third storage
chamber. A polyglucose concentrate is in a fourth storage
chamber.
[0083] This would allow a patient or care giver to selectively mix
one or more concentrates into a ready-to-use improved solution
(over the base solution initially contained in the holding/mixing
chamber). The different glucose concentrates can provide an
iso-osmolar solution or a low osmolarity solution or a high osmolar
solution by adding none, one, or two glucose concentrate
solution(s) into the holding/mixing chamber. [0084] The
mixing/holding chamber contains a base peritoneal dialysis
solution. One of the storage chambers contains a bicarbonate
concentrate. A second storage chamber contains a glucose or
polyglucose concentrate. Mixing the contents of the two storage
chambers into the holding/mixing chamber would provide the
patient/care giver with a ready-to-use bicarbonate buffered,
polyglucose-based solution for a long dwell. [0085] The
mixing/holding chamber contains a base peritoneal dialysis
solution. One of the storage chambers contains a bicarbonate
concentrate. A second storage chamber contains an amino acid
concentrate. Mixing the contents of the two storage chambers into
the holding/mixing chamber would provide the patient/care giver
with a ready-to-use bicarbonate buffered nutritional amino acid
based solution for infusion in conjunction with a meal. [0086] The
mixing/holding chamber is initially empty. One of the storage
chambers contains a glucose based solution. A second storage
chamber contains and amino acid based solution. A third storage
chamber contains a lipid based emulsion. A fourth chamber contains
a trace element based solution. Mixing the contents of two or more
storage chambers would give respectively nutritional solutions
similar to the two-in-one or three-in-one solutions contained in
conventional two chambered or three chambered bags that could be
supplemented with trace elements if necessary. The trace elements
can be contained in one of the storage chambers as described
above.
[0087] It should be understood that various changes and
modifications to the presently preferred embodiments described
herein will be apparent to those skilled in the art. Such changes
and modifications can be made without departing from the spirit and
scope of the present subject matter and without diminishing its
intended advantages. It is therefore intended that such changes and
modifications be covered by the appended claims.
* * * * *