U.S. patent application number 15/438231 was filed with the patent office on 2017-07-06 for device containing first, second and third polymers.
The applicant listed for this patent is Daniel Py. Invention is credited to Daniel Py.
Application Number | 20170190456 15/438231 |
Document ID | / |
Family ID | 42099543 |
Filed Date | 2017-07-06 |
United States Patent
Application |
20170190456 |
Kind Code |
A1 |
Py; Daniel |
July 6, 2017 |
DEVICE CONTAINING FIRST, SECOND AND THIRD POLYMERS
Abstract
A device that includes a first portion including a first
polymer, a second portion including a second polymer, and a third
portion defining a third polymer. The second polymer is
substantially not bondable to the first polymer, and the third
polymer is bondable to the first polymer and fixedly secures the
first portion to the second portion. A device that includes a body
and a closure and including and a first polymer, a second polymer
and a third polymer, wherein the first polymer is bondable with the
second polymer, and the third polymer is substantially not bondable
to the first polymer.
Inventors: |
Py; Daniel; (Larchmont,
NY) |
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Applicant: |
Name |
City |
State |
Country |
Type |
Py; Daniel |
Larchmont |
NY |
US |
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|
Family ID: |
42099543 |
Appl. No.: |
15/438231 |
Filed: |
February 21, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12577104 |
Oct 9, 2009 |
9573741 |
|
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15438231 |
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61104649 |
Oct 10, 2008 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
B65B 3/04 20130101; B65D
2501/0072 20130101; B29L 2031/565 20130101; A61J 1/1406 20130101;
B65D 1/0276 20130101; B29C 2791/001 20130101; B29C 48/0011
20190201; B65D 1/0223 20130101; B29C 65/665 20130101; B65D 47/36
20130101; B65D 55/0818 20130101; A61J 1/1412 20130101; B29K 2101/12
20130101; B65D 1/0284 20130101; B65D 2501/0036 20130101; A61J 1/05
20130101; B65B 7/16 20130101; B65D 2501/0063 20130101; B65D 1/0215
20130101; B67C 2003/227 20130101; B29C 49/22 20130101; B05B
11/00412 20180801; B05B 11/3028 20130101; B65B 51/22 20130101; B29C
66/7371 20130101; B29C 2793/0027 20130101; B29C 48/12 20190201;
B29C 49/04 20130101; B65D 77/06 20130101 |
International
Class: |
B65D 1/02 20060101
B65D001/02; B65D 47/36 20060101 B65D047/36; B05B 11/00 20060101
B05B011/00; B65B 7/16 20060101 B65B007/16; B65B 51/22 20060101
B65B051/22; A61J 1/14 20060101 A61J001/14; B65D 55/08 20060101
B65D055/08; B65B 3/04 20060101 B65B003/04 |
Claims
1. A device comprising: a first portion including a first polymer;
a second portion including a second polymer; and a third portion
defining a third polymer; wherein the second polymer is
substantially not bondable to the first polymer, and the third
polymer is bondable to the first polymer and fixedly secures the
first portion to the second portion.
2. The device of claim 1, wherein the third polymer is bondable to
the second polymer.
3. The device of claim 2, wherein the third portion is bonded to
the second portion.
4. The device of claim 1, wherein the device defines a closure
portion including a penetrable and resealable septum.
5. The device of claim 4, wherein the device defines a storage
chamber therein, and the closure hermetically seals the storage
chamber from ambient atmosphere.
6. The device of claim 5, wherein the storage chamber contains a
substance therein.
7. The device of claim 6, wherein the substance is aseptic or
sterile.
8. The device of claim 5, wherein the storage chamber defines a
variable volume storage chamber.
9. The device of claim 5, wherein the device further defines a pump
and a one-way valve placeable in fluid communication with the
storage chamber to dispense substance from the storage chamber
through the one-way valve and out of the device.
10. The device of claim 9, wherein the storage chamber contains an
aseptic or sterile substance, and the substance is maintained
aseptic or sterile throughout dispensing through the one-way
valve.
11. The device of claim 9, wherein the one-way valve maintains a
hermetic seal between an interior of the device and ambient
atmosphere throughout storage and dispensing of the substance.
12. A device as defined in claim 1, wherein one or more of the
first, second or third polymers are co-molded.
13. A device as defined in claim 1, wherein one or more of the
first, second or third polymers are co-extruded.
14. A device comprising a body and a closure and including and a
first polymer, a second polymer and a third polymer, wherein the
first polymer is bondable with the second polymer, and the third
polymer is substantially not bondable to the first polymer.
15. The device of claim 14, wherein the third polymer is bondable
to the second polymer.
16. A device as defined in claim 15, wherein the second polymer is
bonded to the first and third polymers.
17. A device as defined in claim 14, wherein the body defines a
storage chamber therein, and the closure hermetically seals the
storage chamber from ambient atmosphere.
18. The device of claim 17, wherein the storage chamber contains a
substance therein.
19. The device of claim 18, wherein the substance is aseptic or
sterile.
20. The device of claim 17, wherein the storage chamber defines a
variable volume storage chamber.
21. The device of claim 17, wherein the device further defines a
pump and a one-way valve placeable in fluid communication with the
storage chamber to dispense substance from the storage chamber
through the one-way valve and out of the device.
22. The device of claim 21, wherein the storage chamber contains an
aseptic or sterile substance, and the substance is maintained
aseptic or sterile throughout dispensing through the one-way
valve.
23. The device of claim 21, wherein the one-way valve maintains a
hermetic seal between an interior of the device and ambient
atmosphere throughout storage and dispensing of the substance.
24. A device as defined in claim 14, wherein one or more of the
first, second or third polymers are co-molded.
25. A device as defined in claim 14, wherein one or more of the
first, second or third polymers are co-extruded.
Description
[0001] This application is a continuation of co-pending U.S.
application Ser. No. 12/577,104, filed Oct. 9, 2009, entitled
"Co-Extrusion Blow Molding Apparatus and Method, and Sealed Empty
Devices," now U.S. Pat. No. 9,573,741, which in turn claims
priority to similarly-titled U.S. Provisional Patent Application
Ser. No. 61/104,649, filed Oct. 10, 2008, all of which are hereby
incorporated by reference in its entirety as part of the present
disclosure.
BACKGROUND OF THE INVENTION
[0002] Field of the Invention
[0003] The present invention relates to methods and apparatuses for
devices, such as sealed containers, containing multiple polymers,
and more particularly, to apparatuses and methods for forming such
devices, such as by co-extrusion molding.
[0004] Background Information
[0005] One of the drawbacks of current devices for storing
products, such as food or medicinal products, is that multiple
parts of the devices must be manufactured separately, such as by
molding, and then assembled together. This can be particularly time
consuming and expensive when the devices are used for storing
sterile food products, medicinal products, or other products
requiring sterile filling and/or that must be sealed with respect
to ambient atmosphere during storage and/or use of the devices. For
example, with devices including removable closures, the closures
and bodies must be created separately, and then sterilized, sterile
filled, and assembled in a sterile isolator. These multiple
assembly steps can be time consuming, the maintenance and use of a
sterile isolator for assembling and filling can be complicated and
expensive, and overall the assembly, sterilizing and filling
processes can subject the devices and/or sterile filled products to
an undesirable risk of contamination.
[0006] Accordingly, it is an object of the present invention to
overcome one or more of the above-described drawbacks and/or
disadvantages of the prior art.
SUMMARY OF THE INVENTION
[0007] In accordance with a first aspect, the present invention is
directed to a device comprising a body including a first polymer
and defining a chamber, and a closure including a second polymer
that is substantially not bondable to the first polymer. At least
one of the first and second polymers exhibits a higher shrinkage
rate relative to the other; and at least a portion of the closure
overlaps at least a portion of the body, forming a hermetic seal
therebetween, and defining a sealed, empty, sterile chamber within
the body.
[0008] In some embodiments of the present invention, the body and
closure are co-extrusion blow-molded. In some embodiments, the
closure includes a pierceable and resealable septum. In some such
embodiments, the pierceable and resealable septum includes a third
polymer that is bondable to the second polymer of the closure.
[0009] In some embodiments of the present invention, the body
defines a first portion including the first polymer and further
comprises a third portion including a third polymer that is
relatively flexible in comparison to the first polymer and is
substantially not bondable to the first polymer. A chamber is
hermetically sealable with respect to ambient atmosphere and is
defined by (i) an interior of the third portion, or (ii) a space
formed between the first and third portions.
[0010] In some embodiments of the present invention, the device
further comprises a one-way valve fixedly secured to the body
and/or closure and in fluid communication with the interior of the
body. The one-way valve defines a normally closed position that
hermetically seals the chamber with respect to the ambient
atmosphere, and an open position that allows an aseptic filled
product to flow out of the chamber through the one-way valve. In
some such embodiments, the one-way valve substantially prevents the
ingress of bacteria and other contaminants into the chamber in both
the closed and open positions. In some such embodiments, the
one-way valve includes a flexible valve member that is movable from
the closed to the open position in response to substance at an
inlet to the one-way valve exceeding a valve opening pressure.
[0011] In accordance with another aspect, the present invention is
directed to a device comprising a body; and a penetrable and
thermally resealable portion co-extrusion blow molded with the
body. The body and penetrable and thermally resealable portion
cooperate to define a sealed, empty, sterile chamber.
[0012] Some embodiments of the present invention further comprise a
closure defining the penetrable and thermally resealable portion.
In some such embodiments, the body includes a first polymer; and
the closure includes a second polymer that is substantially not
bondable to the first polymer. At least one of the first and second
polymers exhibits a higher shrinkage rate relative to the other. In
addition, at least a portion of the closure overlaps at least a
portion of the body, forming a hermetic seal therebetween, and
defining a sealed, empty, sterile chamber within the body.
[0013] In accordance with another aspect, the present invention is
directed to a method comprising the following steps:
[0014] (i) extruding a body including a first polymer;
[0015] (ii) co-extruding with the body a closure that includes a
second polymer that is substantially not bondable to the first
polymer, wherein at least one of the first and second polymers
exhibits a higher shrinkage rate relative to the other; and
[0016] (iii) blow molding the co-extruded body and closure and
forming therein an empty, sterile chamber that is sealed with
respect to ambient atmosphere.
[0017] Some embodiments of the present invention further comprise
cooling the blow molded body and closure and, in turn, inducing
shrinkage of the first and second polymers to form a hermetic seal
therebetween. Some embodiments of the present invention further
comprise co-extruding a third portion of the device including a
third polymer that is bondable to the second polymer. Some such
embodiments further comprise co-extrusion blow molding the first,
second and third portions. Some embodiments further comprise
sequentially co-extruding the first and second polymers. Some such
embodiments further comprise extruding a first parison of the first
polymer, and sequentially co-extruding a second parison of the
second polymer surrounding the first parison. Some embodiments
further comprise sequentially co-extruding the first, second and
third polymers and, in turn, fixedly securing the first and second
portions to each other and bonding the third polymer to the second
polymer.
[0018] Some embodiments of the present invention further comprise
aseptically filling the sealed, empty, device with a sterile fluid.
In some such embodiments, the sterile fluid is at least one of a
food and a medicine. In some such embodiments, the food is at least
one of a milk-containing product, a soy-containing product, a
non-dairy creamer, a yogurt-containing product, a fat-containing
product, a nutritional supplement-containing product, and a low
acid product. In some embodiments, the aseptic filling includes
needle penetrating a penetrable portion of the device with an
injection member and aseptically filling the chamber through the
injection member. Some such embodiments further comprise thermally
resealing a resulting fill hole. In other embodiments, the aseptic
filling includes (i) detaching the closure from the body, (ii)
filling the chamber with a fluid through a cannula, (iii)
re-attaching the closure to the body, and wherein steps (i) through
(iii) are performed under an overpressure of sterile gas.
[0019] In accordance with another aspect, the present invention is
direct to a method comprising the following steps:
[0020] (i) extruding a body including a first polymer;
[0021] (ii) co-extruding with the body a penetrable and resealable
portion that includes a second polymer that is bondable to the
first polymer; and
[0022] (iii) blow molding the co-extruded body and resealable
portion and forming therein an empty, sterile chamber that is
sealed with respect to ambient atmosphere.
[0023] Some embodiments further comprise co-extruding with the body
and penetrable portion a closure that includes a third polymer that
is substantially not bondable to the first polymer, wherein at
least one of the first and third polymers exhibits a higher
shrinkage rate relative to the other. In some embodiments, the
second polymer is bondable to the first and third polymers.
[0024] In accordance with another aspect, the present invention is
direct to a device that includes a first portion including a first
polymer, a second portion including a second polymer, and a third
portion defining a third polymer. The second polymer is
substantially not bondable to the first polymer, and the third
polymer is bondable to the first polymer and fixedly secures the
first portion to the second portion.
[0025] In some embodiments, the third polymer is bondable to the
second polymer. Further, in some embodiments, the third portion is
bonded to the second portion. In some embodiments, the device
defines a closure portion including a penetrable and resealable
septum. In some embodiments, the device defines a storage chamber
therein, and the closure hermetically seals the storage chamber
from ambient atmosphere. The storage chamber (e.g., a variable
volume storage chamber) can contain a substance therein, such as an
aseptic or sterile substance.
[0026] In some embodiments, the device further defines a pump and a
one-way valve placeable in fluid communication with the storage
chamber to dispense substance from the storage chamber through the
one-way valve and out of the device. The storage chamber, in
certain embodiments, contains an aseptic or sterile substance, and
the substance is maintained aseptic or sterile throughout
dispensing through the one-way valve. In some embodiments, the
one-way valve maintains a hermetic seal between an interior of the
device and ambient atmosphere throughout storage and dispensing of
the substance.
[0027] In some embodiments, one or more of the first, second or
third polymers are co-molded. In some embodiments, one or more of
the first, second or third polymers are co-extruded.
[0028] In accordance with another aspect, the present invention is
direct to a device that includes a body and a closure and including
and a first polymer, a second polymer and a third polymer. The
first polymer is bondable with the second polymer, and the third
polymer is substantially not bondable to the first polymer.
[0029] In some embodiments, the third polymer is bondable to the
second polymer. In some embodiments, the second polymer is bonded
to the first and third polymers. In some embodiments, the body
defines a storage chamber therein, and the closure hermetically
seals the storage chamber from ambient atmosphere. In some
embodiments, the storage chamber (e.g., a variable volume storage
chamber) contains a substance therein, such as a an aseptic or
sterile substance. In some embodiments, the device further defines
a pump and a one-way valve placeable in fluid communication with
the storage chamber to dispense substance from the storage chamber
through the one-way valve and out of the device. In some
embodiments, the storage chamber contains an aseptic or sterile
substance, and the substance is maintained aseptic or sterile
throughout dispensing through the one-way valve. In some
embodiments, the one-way valve maintains a hermetic seal between an
interior of the device and ambient atmosphere throughout storage
and dispensing of the substance.
[0030] In some embodiments, one or more of the first, second or
third polymers are co-molded. In some embodiments, one or more of
the first, second or third polymers are co-extruded.
[0031] One advantage of the currently preferred embodiments of the
present invention is that the body and removable closure can be
molded at the same time as one part. Yet another advantage of some
currently preferred embodiments of the present invention is that
the co-extruded body and closure form and maintain a sealed, empty
and sterile container.
[0032] Other advantages of the present invention and/or of the
preferred embodiments thereof will become more readily apparent in
view of the following detailed description of the currently
preferred embodiments and accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0033] FIG. 1A is a perspective view of a first embodiment of a
device of the present invention including a co-extrusion, blow
molded body and closure forming a sealed, empty sterile container,
wherein the closure is detachable from the body to sterile fill the
chamber in the body of the container, and is re-attachable to the
body to hermetically seal the sterile filled product within the
container.
[0034] FIG. 1B is a perspective, cross sectional view of the device
of FIG. 1A.
[0035] FIG. 2 is a perspective, partial cross-sectional view of a
second embodiment of a device of the present invention including a
relatively rigid, ball-shaped outer body, a co-extrusion, blow
molded, relatively flexible inner bladder forming a sealed,
variable-volume storage chamber, and a one-way valve, pump and tube
assembly connected to the inner bladder for dispensing
substantially metered doses of sterile filled product
therefrom.
[0036] FIG. 3 is a perspective view of the device of FIG. 2 showing
the device in a substantially emptied condition wherein an upper
portion of the relatively rigid outer container is collapsed
inwardly on itself and on the flexible inner bladder after the
product is dispensed from the variable-volume storage chamber of
the bladder.
[0037] FIGS. 4A and 4B are partially exploded, perspective views of
the device of FIG. 2 illustrating assembly of the valve, pump and
tube assembly to the sealed, empty ball and bladder assembly.
[0038] FIGS. 5A-5F are perspective, partial cross sectional views
of the device of FIG. 2 illustrating the steps for needle filling
the flexible inner bladder through the co-molded needle penetrable
septum, and substantial evacuation of the inner bladder prior to
aseptic needle filling thereof.
[0039] FIG. 6 is a partial, perspective, cross-sectional view of
the device of FIG. 2 illustrating the formation of an aperture or
like slit in the outer ball to allow the flow of air therethrough
and into the space between the outer ball and flexible inner
bladder.
[0040] FIGS. 7A-7F are perspective, partial cross sectional views
of the device of FIG. 2 illustrating the steps for aseptic needle
filling the flexible inner bladder through the co-molded, needle
penetrable septum.
[0041] FIG. 8 is a perspective, partial cross-sectional view of the
device of FIG. 2 illustrating the steps of laser resealing the
resulting needle hole formed in the co-molded septum.
[0042] FIG. 9 is a partial, cross-sectional view of another
embodiment of a device of the present invention including a
co-molded body and closure, wherein the closure includes a
penetrable and resealable septum for aseptically filling the
sterile empty device.
[0043] FIG. 10 is a schematic illustration of an apparatus of the
present invention for sterile filling devices of the type disclosed
herein.
[0044] FIGS. 11A-11C are perspective views illustrating an
apparatus for co-extrusion blow molding devices of the type
disclosed herein, including an extrusion head for co-extruding a
plurality of parisons of predetermined plastic materials for
forming sealed, empty devices, mold halves mounted below the
extrusion head and movable into engagement with each other and the
co-extruded parisons for receiving the extruded plastic materials
in their cavities, a blow pin in fluid communication with the
interiors of the parison and cavities of the mold halves for
blowing sterile filtered air therein and forming the sealed empty
devices defining sealed empty sterile chambers, and a source of
sterile filtered air or other gas that provides an over pressure of
sterile gas horizontally, vertically, or otherwise over the
surfaces involved in the molding processes.
[0045] FIGS. 12A and 12B are cross-sectional views illustrating the
mold in a closed condition, the blow pin injecting sterile air or
other gas into the interior of the mold to blow the device into the
shape of the mold, and a mechanism for pinching the blow pin hole
after withdrawal of the blow pin to form the sealed, empty device
defining a sterile interior chamber.
[0046] FIG. 13 is a perspective view illustrating release of the
sealed, empty device from the mold.
[0047] FIG. 14A is a perspective view of the device of FIG. 9
illustrating application of a tamper evident tape to the interface
of the closure and body.
[0048] FIG. 14B is a perspective view of the device of FIG. 9
illustrating sterilization of at least the needle penetrable
surface of the closure, such as by the application of VHP or other
fluid sterilant, prior to aseptic filling therethrough.
[0049] FIGS. 15A-15C are perspective views of the device of FIG. 9
illustrating the steps involved in aseptically filling the device
through the penetrable septum and into the sterile chamber.
[0050] FIGS. 16A-16B are perspective views of the device of FIG. 9
illustrating withdrawal of the filling needle from the closure
septum and laser sealing of the resulting needle hole to
hermetically seal the aseptically filled product within the device
chamber.
[0051] FIG. 16C is a perspective view of the device of FIG. 9
illustrating the steps involved in applying an over cap to the
needle penetrable and laser resealed closure to protect the closure
and later facilitate manual gripping and removal of the closure to
dispense product from the device.
[0052] FIGS. 17A-17C are perspective views of the device of FIG. 9
illustrating the steps involved in removing the tamper evident tape
from the interface of the closure and body neck, and removal of the
over cap by gripping the pull tab to open the device and dispense
the filled product therefrom.
DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION
[0053] In FIGS. 1A and 1B, a device embodying the present invention
is indicated generally by the reference numeral 10. In the
illustrated embodiment, the device 10 includes a body 12 including
a first polymer, and a closure 14 that includes a second polymer
that is substantially not bondable to, and has a relatively higher
shrinkage rate than, the first polymer. As shown best in FIG. 1B,
the body 12 defines an interior chamber 16 and includes a neck 18
defining a filling and dispensing aperture 20. The neck 18 defines
first and second annular flanges 22 and 24, respectively, that are
axially spaced relative to each other, and an annular groove 26
extending axially therebetween. The closure 14 is defined by an
upper wall 28 and an annular flange 30 depending therefrom. As can
be seen, a portion 32 of the annular flange 30 overlaps a portion
34 of the neck 18. The overlapping portion 32 of the closure 14
defines an annular groove 36 that receives therein the second
annular flange 24 of the neck 14, and defines an annular flange 35
that is received within the annular groove 26 of the neck. Due to
the relatively higher shrinkage rate of the material forming the
closure 14 in comparison to the material forming the neck 18, the
overlapping portions 32 and 34 of the closure and neck,
respectively, are compressed into engagement with each other at the
time of formation, as described further below, and form a hermetic
seal therebetween. As also described further below, in the
illustrated embodiment, the body and closure 12 and 14,
respectively, are co-extruded, and preferably are sequentially
co-extrusion blow-molded. As a result, the chamber 16 of the device
is hermetically sealable with respect to ambient atmosphere. In
addition, as described further below, because the first polymer is
substantially not bondable to the second polymer, the closure 14 is
detachable from the neck 18 to aseptically fill the empty chamber
16, and is re-attachable to the neck 18 to secure the closure 14 to
the neck and form a hermetic seal therebetween. The flanges 22, 24
of the neck 18 interlock with the groove 36 and flange 35 of the
closure 14 and, in turn, releasably retain the closure to the neck
while forming a hermetic seal therebetween. As may be recognized by
those of ordinary skill in the pertinent art based on the teachings
herein, the device may include any of numerous other structures,
features or devices that are currently known, or that later become
known, for releasably retaining the closure to the body and forming
a hermetic seal therebetween.
[0054] In FIGS. 2 through 8, another embodiment of a device of the
present invention is indicated generally by the reference numeral
110. The device 110 is substantially similar to the device 10
described above, and therefore like reference numerals preceded by
the numeral "1" as used to indicated like elements. A primary
difference of the device 110 in comparison to the device 10 is that
the device 110 includes a relatively rigid, ball-shaped outer body
112, a co-extrusion, blow molded, relatively flexible inner bladder
115 forming a sealed, variable-volume storage chamber 116, and a
one-way valve 127, pump 125 and tube 121 assembly connected to the
inner bladder 115 for dispensing substantially metered doses of
sterile filled product therefrom, as hereinafter described.
[0055] As shown in FIGS. 2-4, the device 110 defines a relatively
rigid, substantially spherical-shaped outer body 112 defining in
the upper hemispherical portion thereof a plurality of annular
pleats 113 that are axially spaced relative to each other. As shown
typically in FIG. 3, the pleats 113 allow the upper hemispherical
portion of the outer body 112 to invert or fold inwardly on itself
upon dispensing product from the flexible inner bladder. As shown
best in FIG. 6, each pleat 113 is defined by an annular rib
extending radially outwardly of outer body 112, and that forms a
pivot allowing the outer body to be folded inwardly on itself at
the respective pleat. As may be recognized by those of ordinary
skill in the pertinent art based on the teachings herein, the term
"pleat" is used to refer to, and may take the form of, any of
numerous different structures or features that are currently known,
or that later become known, that allow the outer body to collapse
of fold inwardly on itself.
[0056] The device 110 also includes a relatively flexible inner
body 115 that defines a variable volume chamber 116 (FIG. 6). Like
the outer body 112, the flexible inner body 115 is substantially
spherical-shaped and defines in the upper hemispherical portion
thereof a plurality of annular pleats 117 that are axially spaced
relative to each other. As shown typically in FIGS. 5A through 5F,
the inner body 115 is defined by a flexible bladder that is
relatively flexible in comparison to the outer body 112. As shown
typically in FIG. 3, the pleats 117 allow the upper hemispherical
portion of the inner bladder 115 to invert or fold inwardly on
itself upon dispensing product therefrom.
[0057] As shown typically in FIG. 4A, the outer body 112 defines an
upwardly extending neck 118 receiving therein a closure 114. The
neck 118 defines first and second annular flanges 122 and 124,
respectively, and an annular grove 126 extending axially
therebetween. The closure 114 defines a penetrable and thermally
resealable septum 128 and an annular flange 130 depending therefrom
(see FIG. 5A). As shown in FIG. 5A, the neck 118 overlaps the
depending flange 130 of the closure 114 and is bonded thereto to
form a hermetic seal therebetween. As also shown, the depending
flange 130 of the closure 114 includes a corresponding recess and
flanges that interlock with the recess and flanges of the neck 118
to further secure the closure to the neck. The depending flange 130
of the closure 114 is bonded (preferably by sequential co-extrusion
molding, as described further below) to the upper portion of the
flexible inner bladder 115 such that the closure 114 is formed
integral with the inner bladder, and the inner bladder 115 is
supported within the outer body 112, at least in part, by the
closure. In the illustrated embodiment, the outer body 112 includes
a first polymer, the flexible inner bladder 115 includes a second
polymer that is not bondable to the first polymer of the outer
body, and the closure 114 includes a third polymer that is bondable
to the first polymer of the outer body 112 and to the second
polymer of the inner bladder 115, such that upon co-extrusion blow
molding the three components, the closure 114 is bonded to, and
formed integral with both the neck 118 of the outer body 112 and
the upper portion of the inner bladder 115 to fixedly secure, and
hermetically seal, the inner bladder 115 within the outer body
112.
[0058] The device 110 further includes and a one-way valve 127, an
actuator/pump 125 and a flexible tube 121 assembly connectable to
the inner bladder 115 through the closure septum 128 for dispensing
substantially metered doses of sterile filled product therefrom.
The dome-shaped actuator and pump assembly 125 is manually
engageable to depress the dome-shaped actuator and, in turn, pump a
substantially predetermined volume of product from the inner
bladder 115 through the one-way valve 127. A flexible tube 121 is
connected between the inlet to the actuator/pump 125 and an over
cap 115. As shown in FIGS. 4A and 4B, the over cap 115 includes a
piercing member 123 defining a plurality of apertures therethrough
in fluid communication with the tubular conduit 121 for piercing
the hermetically sealed, resealable septum 128 of the closure 114
and, in turn, connecting the conduit 121 into fluid communication
with the inner bladder 115. As shown in FIGS. 4A and 4B, the over
cap 115 includes on an interior surface thereof an annular flange
131 that is engageable with the annular recess 126 of the neck 118
to fixedly secure the over cap to the neck. If the over cap is not
attached to the closure 114 in the sterile filling machine, the
over cap 115 may be provided in sterile packaging or may be
provided with an overlay of foil, tape or like sealed covering (not
shown) to maintain the piercing member sterile prior to piercing
the closure, and the closure similarly may be provided with a foil,
tape or like covering (not shown) that maintains the piercing
surface sterile prior to piercing. If desired, a plug 129 may be
received within the open end of the nozzle 119 at the outlet of the
one-way valve 127 to protect the valve during transport and
storage, and otherwise prevent any accidental dispensing of product
through the valve during transport or storage.
[0059] In the illustrated embodiment, the one-way valve 127
maintains a hermetic seal between the interior of the device 110
and ambient atmosphere throughout any storage and usage of the
valve. Accordingly, the one way valve 127, actuator/pump 125, and
other components of the nozzle may take the form of any such
components disclosed in any of the following patent applications
and patents that are hereby incorporated by reference in their
entireties as part of the present disclosure: U.S. patent
application Ser. No. 11/650,102, filed on Jan. 5, 2007, which
claims priority to U.S. Provisional Patent Application 60/757,161,
filed on Jan. 5, 2006; U.S. patent application Ser. No. 12/021,115,
filed on Jan. 28, 2008; which is a continuation of U.S. patent
application Ser. No. 11/295,251, filed on Dec. 5, 2005, now U.S.
Pat. No. 7,322,491, which claims priority to U.S. Provisional
Patent Applications 60/633,332 filed on Dec. 4, 2004 and 60/644,160
filed on Jan. 14, 2005; U.S. patent application Ser. No.
11/295,274, filed on Dec. 5, 2005, now U.S. Pat. No. 7,278,533;
U.S. patent application Ser. No. 11/949,104, filed on Dec. 3, 2007,
which is a continuation of U.S. patent application Ser. No.
11/900,335, filed on Sep. 10, 2007; U.S. patent application Ser.
No. 11/900,227, filed on Sep. 10, 2007; U.S. patent application
Ser. No. 11/900,332, filed on Sep. 10, 2007; U.S. provisional
Patent Application No. 60/843,131, filed on Sep. 8, 2006.
[0060] As indicated above, the flexible inner body 115 is defined
by a third polymer that is substantially not bondable to the
polymer of the outer body 112. As shown best in FIGS. 5A-5F, the
flexible inner body 115 is evacuated and made ready for fluid
filling via a needle or like injection member 131 coupled in fluid
communication with a vacuum source (not shown). As can be seen, a
non-coring needle 131 is inserted through the penetrable septum 128
of the closure 114 to place the open end of the needle into the
variable-volume storage chamber 116. Then, the vacuum source is
activated to draw a vacuum through the needle and, in turn, draw
air out of the variable volume chamber 116. As shown in FIG. 6, the
flexible inner body 115 is able to collapse away from the outer
body 112 because a slot 133 is formed in the body 112 that, in
turn, allows ambient air to flow into the space between the inner
and outer bodies. As shown in FIGS. 5A-5F, this in turn allows the
flexible inner body 115 to collapse as its contents are evacuated.
The slot 133 is formed by introducing an axially-elongated strip
135 in the shape of the desired slot formed of the same material as
the inner bladder into the parison forming the outer body. The
material forming the strip 135 and the inner bladder is comprised
of a polymer that is substantially not bondable to the polymer of
the outer body 112. As a result, the strip 135 does not bond to the
outer body 112 during the extrusion and/or blow mold process, but
does bond to the inner bladder 115, thus forming the resulting slot
133 in the outer body.
[0061] As shown best in FIGS. 7A-7E, the evacuated inner body 115
is sterile or aseptically filled with a fluid or desired product by
the same needle or like injection member 131. Alternatively, a
different needle or injection member may be employed. In either
case, after evacuating (or otherwise drawing a desired amount of
gas out of the chamber) the variable-volume storage chamber 116 of
the inner bladder 115, the product is injected through the needle
and into the storage chamber. In the illustrated embodiment, and as
shown in FIG. 7E, when the inner bladder 115 is filled, it is
expanded into contact, or substantially into contact, with the
outer body 112. As shown in FIG. 8, and as described further below,
after filling the inner bladder 115, the filling member 131 is
withdrawn and the resulting penetration aperture is thermally
resealed, such as by the application of laser radiation 144
thereto. As described further below, in the illustrated
embodiments, the outer body 112, flexible inner body 115 and
resealable portion 114 are co-extruded, and preferably are
sequentially co-extrusion blow-molded. One advantage of this
approach is that the molding process provides a sealed, empty,
sterile device, such as a container, that is ready for aseptic
filling, and such device does not require gamma or other
sterilization of the product chamber prior to filling.
[0062] Turning to FIG. 9, another embodiment of a device of the
present invention is indicated generally by the reference numeral
210. The device 210 is substantially similar to the devices 10 and
110 described above, and therefore like reference numerals are
preceded by the numeral "2," or preceded by the numeral "2" instead
of the numeral "1," are used to indicate like elements. The device
210 is substantially similar to the device 10 described above in
connection with FIGS. 1A and 1B, the primary difference being that
the closure 214 includes a needle penetrable and thermally
resealable septum 228 in the upper wall thereof. The septum 228 is
provided for needle filling and thermally resealing, such as with
laser radiation, as described above. In addition, the neck 218 of
the body 212 defines an annular recess 226, and the depending
flange 230 of the closure 214 defines a corresponding annular
flange 236 that is received within the corresponding recess 226 of
the neck. As a result, the closure interlocks with the neck to
releasably retain the closure on the neck and form a hermetic seal
therebetween. As with the embodiments described above, the
components of the device 210 preferably are sequentially
co-extrusion, blow molded to form in the mold a sealed, empty,
sterile device. In the illustrated embodiment, the body 212
includes a first polymer and the closure 214 is defined by a
resealable portion 240 and a base portion 241. Closure 214 defines
a hermetic seal with body 212, hermetically sealing chamber 216, as
described in the above embodiments. In addition, the resealable
portion 228 includes a third polymer that is substantially bondable
to the second polymer of the closure 214 to bond the resealable
portion to the closure. Additionally, because the first polymer
forming the neck 218 is substantially not bondable to the second
polymer forming the flange 230 of the closure 214, the closure is
removable from the body 212 when ready to dispense the product
therefrom.
[0063] Turning to FIGS. 11A-11C, 12A, 12B and 13, an exemplary
co-extrusion blow molding apparatus and method is illustrated in
further detail. In FIG. 11A, and in an exemplary embodiment, the
body parison 48 is extruded from the extrusion head 54. As
indicated by the multiple arrows in FIG. 11A, an overpressure of
sterile air or other gas is directed laterally or horizontally over
the extrusion and the mold surfaces that are adjacent to or receive
the extrusion. If desired, an overpressure of sterile air or other
gas can be directed through the parison as indicated by the
downwardly directed arrows in FIG. 11A. In FIG. 11B, after a
predetermined time or, alternatively, once the extruded body
parison 48 reaches a predetermined length, the closure parison 50
is extruded from the extrusion head 54. Both parisons 48 and 50
form, in the illustrated embodiment, a hollow and tubular shape. As
shown in FIG. 11B, the parisons are released into the mold 46,
which is defined by two mold halves, 56 and 58, respectively. The
blow pin 52 is located below the mold 46 and extrusion head 54 and
is aligned with the parison(s) so that it is in fluid communication
with interior of the parison(s) and the mold cavity. As shown in
FIG. 11C, each of the mold halves 56 and 58 is moved laterally into
engagement with each other and with the parisons, and the parisons
are severed from the extrusion head 54. During these steps, the
flow of sterile air is maintained, as indicated by the arrows in
FIGS. 11B and 11C.
[0064] As shown best in FIG. 12A, pressurized (and sterile) air is
introduced into the hollow center of the parisons 48, 50 from the
blow pin 52, expanding the parisons into the shape of the mold to,
in turn, form, in the illustrated embodiment, the body 12 and
closure 14, respectively. As shown in FIG. 12B, the blow pin 52 is
removed and the material surrounding the aperture formed therefrom
is pinched together via a clamp 60 while the device 10 is still
relatively hot and pliable in order to seal the blow pin aperture
(not shown). The device 10 is then allowed to cool to ambient
temperature and, as a result, the differential shrinkage rates of
the first and second polymers causes the closure 14 to shrink
around the body 12 and form a hermetic seal therebetween. Next, as
shown in FIG. 13, the mold 46 is opened, leaving the device 10
including a sealed, empty chamber 16 that is hermetically sealed
with respect to ambient atmosphere.
[0065] As shown in FIG. 14A, in some embodiments, the device 10
further includes a tamper evident portion 62 surrounding the
closure 14, which is applied after the device 10 is removed from
the mold 46. In the illustrated embodiment, the tamper evident
portion is a tape, shrink-wrap of other tamper evident seal that
will break in the event the closure is opened, or otherwise if the
seal between the closure and neck is broken.
[0066] Accordingly, and with reference to FIG. 10, the manufacture
of the filled devices 10 described above in connection with FIGS.
1A and 1B includes the following steps:
1. Extrude the body 12 of the container 10. 2. Sequentially
co-extrude the closure 14 (i.e., release the closure parison after
initial release of the body parison) so that the closure 14 and
body 12 overlap each other in the neck region 18 of the body 12.
The container bodies 12 and closures 14 may be single layer
materials or may be formed of multiple layer materials as is
conventional in the art. 3. Terminate extrusion of the body 12
parison at the inlet to the neck 18, but continue to form the
closure 14 to complete the portion of the closure above the neck.
4. Close the mold halves 56, 58 around the sequential, co-extruded
body and closure. 5. Inject sterile filtered (micro-filtered) air
or other gas through the blow pin 52 into the interior of the
parisons and mold cavity to expand the co-extruded parisons into
engagement with the cavity walls and, in turn, complete formation
of the closed container defining a sealed, empty, sterile interior
chamber 16. 6. Form the closure 14 and container body 12 of
different thermoplastics that are not bondable to each other, and
that define different shrinkage (or shrinkage rates). The plastic
with the higher shrinkage is located on the outside so that it
compresses against the inner layer of plastic and forms a hermetic
seal therebetween. In the illustrated embodiment, the closure
exhibits higher shrinkage and therefore surrounds the neck. If, on
the other hand, the body exhibits higher shrinkage, the neck would
surround the closure to form a hermetic seal therebetween. 7.
Introduce the sealed empty sterile containers 10 (i.e., bodies 12
with closures 14 integrally molded thereto) into the filling
machine 50. [0067] In a first station 52 (if necessary), sterilize
the exteriors of the containers with, e.g., a fluid sterilant 64,
such as VHP, or with radiation, such as ebeam, etc. [0068] In a
second station 54, robotically or otherwise remove the closures 14
from the bodies 12 and sterile fill the chambers 16 through the
necks 18. This stage can be performed under an overpressure of
sterile air (e.g., downwardly directed flow, or laterally directed
flow). A traditional filling cannula can be used to sterile fill
through the open necks of the containers. Then, after filling, the
closures 14 are re-attached to the necks 18 to seal the sterile
filled products within the containers 10. [0069] As described
above, the interface of the closure 14 and neck 18 is such that a
hermetic seal is formed therebetween due to the compression created
by the differential rates of shrinkage of the plural non-bondable
thermoplastic layers upon cooling the molded part to ambient
temperature. However, because the plural layers are not bondable to
each other, the closure 14 can be mechanically removed from the
neck (such as by a robotic arm or other automated fixture of a type
known to those of ordinary skill in the pertinent art) to fill the
body, and then is re-attached to the neck after sterile filling
with the same fixture to, in turn, seal the sterile filled product
within the container. In use, the product is dispensed by gripping
the closure 14 by hand and manually lifting or pivoting the closure
away from the neck to remove the closure and expose the open neck.
8. After sterile filling and sealing, the sealed, sterile filled
containers are discharged to an outlet station 56 of the filling
machine. The outlet station 56 may include conventional quality
control features, such as sensors for determining correct fill
levels and/or leakage, devices for labeling, providing tamper
evidence seals, etc.
[0070] Also with reference to FIG. 10, the manufacture of the
filled devices 110, 210 include the following steps:
1. Extrude the body 112, 212 of the container 110, 210; 2.
Sequentially co-extrude the inner bladder 115 and closure 114, or
the closure 214, including the needle penetrable portions 128, 228
so that the inner and outer parisons overlap at the select
portion(s), e.g., in the neck regions 118, 218; 3. Terminate
extrusion of the body 112, 212 parison at the inlet to be covered
by the penetrable/resealable portion, but continue to form the
penetrable/resealable closure over the inlet to body; 4. Close the
mold halves 56, 58 around the co-extruded part 110, 210; 9. Inject
sterile filtered (micro-filtered) air or other gas through the blow
pin 52 into the interior of the parisons and mold cavity, expand
the co-extruded parisons into engagement with the cavity walls and,
in turn, complete formation of the closed container defining a
sealed, empty, sterile interior chamber 116, 216. 5. Form the
needle penetrable closure 128, 228 of elastomeric material, and
form the container body 112, 212 of relatively rigid material that
are bondable to each other upon molding to form a hermetic seal
therebetween (i.e., the different materials bind together when
blown, e.g., by having at least one common constituent). The
elastic material of the closure typically exhibits a higher
shrinkage than the relatively rigid or less flexible material of
the body, such as PP (polypropylene) or PE (polyethylene)).
Accordingly, the higher shrinkage closure may be located on the
outside so that it compresses against the lower shrinkage body to
facilitate bonding of the two materials and the formation of the
hermetic seal therebetween. Alternatively, the higher shrinkage
closure is configured to avoid stretching thereof or other
undesirable stress in the part upon cooling same to ambient
temperatures. 6. Introduce the sealed empty sterile containers 110,
210 (i.e., bodies 112, 212 with needle penetrable closures 128, 228
bonded thereto) into filling machine. [0071] In a first station 52
(if necessary), sterilize the needle penetrable portions of the
containers with, e.g., a fluid sterilant 64, such as VHP, or with
radiation, such as ebeam, etc. As shown in FIG. 14B, in an
exemplary apparatus, the first station 52 includes a sterilization
apparatus 64 that sterilizes the device 10 with, for example, a
fluid sterilant, such as vaporized hydrogen peroxide ("VHP"). In
the event VHP is used, a heated gas is transmitted onto the
surfaces of the device 10 to evaporate the fluid sterilant and, in
turn, provide dry sterile bodies 12 for subsequent filling and
sealing. If desired, other sterilizing mechanisms equally may be
employed, such as ebeam, gamma or other irradiation. [0072] In a
second station 54, evacuate, if necessary, and needle fill the
sealed, empty containers through the elastomeric closures with the
needle 131. This stage can be performed under an overpressure of
sterile air (e.g., downwardly directed flow, or laterally directed
flow). As shown in FIG. 15A, in the exemplary embodiment of the
device 210, the filling step includes penetrating the penetrable
and thermally resealable portion 228 with an injection member, such
as the needle 131. As shown in FIG. 15B, the injection member 131
is thereby placed in fluid communication with the chamber 216. As
illustrated in FIG. 15C, the chamber 216 is thereby filled with
fluid through the injection member 131. As shown in FIGS. 16A and
16B, after the chamber 216 is filled, the needle 131 is withdrawn.
Preferably, the penetrable septum 228 is self-sealing. However, as
shown in FIG. 16B, if desired or otherwise required, the aperture
may be thermally resealed, such as by applying laser energy 144.
[0073] As shown in FIG. 16C-17C, an over cap 270 may be fixedly
secured to the closure 214. In one embodiment, the over cap 270 is
thermally clamped to the closure 214 to fixedly secure the over cap
to the closure and prevent tampering with the underlying penetrable
septum 228. In the illustrated embodiment, the over cap 270
includes a pull-tab 272 to facilitate manual gripping of the over
cap to, in turn, remove the over cap and closure fixed thereto when
the product is ready for dispensing. As may be recognized by those
of ordinary skill in the pertinent art based on the teachings
herein, the over cap may take any of numerous different forms or
configurations, and may be fixedly secured or otherwise attached to
the closure, in any of numerous different ways, that are currently
known, or that later become known. For example, in some
embodiments, the needle penetrable material is sufficiently elastic
to close itself after filling and removal of the needle. In these
embodiments, the over cap may be fixedly secured to the body
overlying the needle penetrated region to hermetically seal the
container at that region. [0074] In use, the user removes the
tamper evident portion 262, and then grips and pulls the pull-tab
272. This motion substantially simultaneously removes the over
closure 270 and the closure 214, and allows the user to dispense
product from the chamber 216 through the neck 218 and aperture 220.
[0075] After sterile filling and sealing, the sealed, sterile
filled containers are discharged to an outlet station 56 of the
filling machine. The outlet station 56 may include conventional
quality control features, such as sensors for determining correct
fill levels and/or leakage, devices for labeling, providing tamper
evidence seals, etc. As indicated schematically in FIG. 10, the
apparatus 50 includes a motorized conveyor 50 for transporting the
devices through the above-described stations.
[0076] As indicated above, the penetrable and thermally resealable
portions 128, 228 allow filling therethrough of the chambers 116,
216 with a needle or like injection member 131, 231, and thermal
resealing of the resulting penetration aperture, such as by
applying laser radiation thereto. The devices 110, 210 may be
filled and thermally resealed, or aseptically filled with other
filling members and sealed within the containers or other devices,
with any of numerous different apparatus in any of numerous
different ways that are currently known, or that later become
known, including any of the devices and apparatus and methods for
filling disclosed in any of the following patent applications and
patents that are hereby incorporated by reference in their
entireties as part of the present disclosure: U.S. patent
application Ser. No. 11/949,097, filed Dec. 3, 2007, entitled
"Device with Needle Penetrable and Laser Resealable Portion and
Related Method," similarly-titled U.S. patent application Ser. No.
11/933,300, filed Oct. 31, 2007, both of which are continuations of
similarly-titled U.S. patent application Ser. No. 11/879,485, filed
Jul. 16, 2007, which is a continuation of U.S. application Ser. No.
11/408,704, filed Apr. 21, 2006, entitled "Medicament Vial Having a
Heat-Sealable Cap, and Apparatus and Method for Filling the Vial,"
now U.S. Pat. No. 7,243,689, which is a continuation of U.S. patent
application Ser. No. 10/766,172 filed Jan. 28, 2004, entitled
"Medicament Vial Having A Heat-Sealable Cap, And Apparatus and
Method For Filling The Vial," now U.S. Pat. No. 7,032,631, which is
a continuation-in-part of similarly titled U.S. patent application
Ser. No. 10/694,364, filed Oct. 27, 2003, which is a continuation
of similarly titled co-pending U.S. patent application Ser. No.
10/393,966, filed Mar. 21, 2003, which is a divisional of similarly
titled U.S. patent application Ser. No. 09/781,846, filed Feb. 12,
2001, now U.S. Pat. No. 6,604,561, issued Aug. 12, 2003, which, in
turn, claims the benefit of similarly titled U.S. Provisional
Application Ser. No. 60/182,139, filed Feb. 11, 2000; similarly
titled U.S. Provisional Patent Application No. 60/443,526, filed
Jan. 28, 2003; similarly titled U.S. Provisional Patent Application
No. 60/484,204, filed Jun. 30, 2003; U.S. patent application Ser.
No. 11/933,272, filed Oct. 31, 2007, entitled "Sealed Containers
And Methods Of Making And Filling Same," which is a continuation of
similarly-titled U.S. patent application Ser. No. 11/515,162, filed
Sep. 1, 2006, which is a continuation of similarly-titled U.S.
patent application Ser. No. 10/655,455, filed Sep. 3, 2003, now
U.S. Pat. No. 7,100,646, U.S. patent application Ser. No.
10/983,178 filed Nov. 5, 2004, entitled "Adjustable Needle Filling
and Laser Sealing Apparatus and Method;" U.S. patent application
Ser. No. 11/901,467, filed Sep. 17, 2007, entitled "Apparatus and
Method for Needle Filling and Laser Resealing," which is a
continuation of similarly-titled U.S. patent application Ser. No.
11,510,961, filed Aug. 28, 2006, which is a continuation of
similarly-titled U.S. patent application Ser. No. 11/070,440 filed
Mar. 2, 2005; U.S. patent application Ser. No. 11/074,513 filed
Mar. 7, 2005, entitled "Apparatus for Molding and Assembling
Containers with Stoppers and Filling Same;" U.S. patent application
Ser. No. 11/074,454 filed Mar. 7, 2005, entitled "Method for
Molding and Assembling Containers with Stoppers and Filling Same,"
U.S. patent application Ser. No. 11/339,966, filed Jan. 25, 2006,
entitled "Container Closure With Overlying Needle Penetrable And
Thermally Resealable Portion And Underlying Portion Compatible With
Fat Containing Liquid Product, And Related Method;" and U.S. patent
application Ser. No. 11/786,206, filed Apr. 10, 2007 entitled
"Ready To Drink Container With Nipple And Needle Penetrable And
Laser Resealable Portion, And Related Method;" U.S. patent
application Ser. No. 11/650,102, filed Jan. 5, 2007, entitled
"One-Way Valve, Apparatus and Method of Using the Valve," which is
a continuation of similarly-titled U.S. patent application Ser. No.
11/295,274, filed Dec. 5, 2005, entitled; U.S. patent application
Ser. No. 12/021,115, filed Jan. 28, 2008, entitled "Method of Using
One-Way Valve and Related Apparatus," which is a continuation of
U.S. patent application Ser. No. 11/295,251, filed Dec. 5, 2005,
entitled "One-Way Valve, Apparatus and Method of Using the
Valve."
[0077] As may be recognized by those of ordinary skill in the
pertinent art based on the teachings herein, the devices may be
filled via filling assemblies which take any of numerous different
configurations that are currently known, or that later become
known. For example, the filling assemblies may have any of numerous
different mechanisms for sterilizing, feeding and/or aseptically
filling the liquid components into the sealed empty chamber(s). In
addition, rather than use a penetrable and resealable portion or
cannula, the device may employ filling valves and filling members
for filling through the filling valves as disclosed, for example,
in the following patent and patent applications which are hereby
incorporated by reference in their entireties as part of the
present disclosure: U.S. application Ser. No. 12/025,362, filed
Feb. 4, 2008, entitled "Dispenser and Apparatus and Method for
Filling a Dispenser," which is a continuation of similarly-titled
U.S. application Ser. No. 11/349,873, filed Feb. 8, 2006, which is
a continuation of similarly-titled U.S. application Ser. No.
10/843,902, filed May 12, 2004, now U.S. Pat. No. 6,997,219, issued
Feb. 14, 2006; U.S. application Ser. No. 11/938,103, filed Nov. 9,
2007, entitled "Device with Chamber and First and Second Valves in
Communication Therewith, and Related Method," which is a divisional
of U.S. application Ser. No. 10/976,349, filed Oct. 28, 2004,
titled "Container and Valve Assembly for Storing and Dispensing
Substances, and Related Method." In such alternative embodiments, a
first valve is formed or otherwise mounted on the container in
fluid communication with the storage chamber to fill the storage
chamber therethrough. In addition, the container may include a
second valve formed on or otherwise mounted on the container for
allowing gas to flow out of the storage chamber during filling
thereof, or to allow drawing or evacuation of gas from the storage
chamber during filling thereof.
[0078] The term "sterile" should be understood to mean that the
product in question complies with the respective microbiological
standard prescribed for products of that type in national and
international legislation. For example, the components in
embodiments of the present invention can be rendered sterile by
techniques which are explicitly designed to reduce or eliminate
interactions and heat reactions of proteins and lipids, proteins
and carbohydrates and/or to reduce damage to or decomposition of
heat labile macro- and micronutrients, such as nucleotides,
vitamins, probiotics, long chain polyunsaturated fatty acids, etc.
A variety of suitable techniques is available. Some of these
techniques rely on the application of heat (i.e., thermally
sterilized), for example, such as retorting and aseptic processing.
Other non-heat or "cold sterilization" techniques include, for
example, bacterial filtration or microfiltration, high-pressure
sterilization and irradiation. These techniques may be selected and
combined as appropriate in the production of specific formulas or
products according to the intended use of the formulas or products
of the present invention.
[0079] As may be recognized by those of ordinary skill in the
pertinent art based on the teachings herein, numerous changes and
modifications may be made to the above-described and other
embodiments of the present invention without departing from its
scope as defined in the appended claims. For example, the polymers
described herein, and the monomers forming each of the polymers,
may take the form of any of numerous different polymers and/or
monomers that are currently known, or that later become known, for
performing the functions of the polymers and monomers as described
herein. In addition, in some embodiments the closure 14 includes a
polymer that has a higher shrinkage rate than the polymer of the
body 12. In that instance, the closure 14 would fit within the neck
of the body 12, rather than around it, so as to form an
interference fit therebetween. In other embodiments, the closure 14
is not be removable from the body 12, either because it is fixedly
secured thereto or because the first polymer of the body 12 is
substantially bondable to the second polymer of closure 14. In
addition, the devices may take any of numerous different
configurations, and the components of the devices may take any of
numerous different physical and/or chemical characteristics, that
are currently known, or that later become known. For example, the
shape of the body or closure may take on any form that is known or
becomes known. Similarly, the stripe and slot may take on any shape
or size for performing its function and the invertible portion(s)
may be made in any shape that is known or becomes known for
inversion, pliability or other purposes. For example, the
invertible portion may include a relatively pliable polymer, and
the relatively rigid portion may include a relatively rigid polymer
that is bondable to the relatively pliable polymer. Similarly, the
cap and nozzle may take the form of any of numerous different caps
or nozzles that are currently known, or that later become known,
for sealing and dispensing, respectively.
[0080] In the illustrated embodiment, the fluid flow aperture is in
the nature of a bottle neck; however, as may be recognized by those
of ordinary skill in the pertinent art based on the teachings
herein, the fluid-flow aperture may take any of numerous different
configurations that are currently known, or that later become
known. For example, if desired, the fluid-flow aperture may include
within it or otherwise be defined as a one-way valve, such as a
check valve, to allow the contents of the chamber to self-regulate
in response to pressure and/or temperature changes. Preferably,
such as in the application of the device for food products, such as
sterile foods, or medicinal products, the one-way valve
substantially prevents the ingress of bacteria and other
contaminants into the chamber 16 in both the closed and open
positions (i.e., throughout storage and the period of dispensing of
product from the device). Exemplary valve configurations that may
be used in connection with the methods and apparatus of the present
invention include those described in the following patent and
patent applications which are hereby incorporated by reference in
their entireties as part of the present disclosure: U.S.
application Ser. No. 12/025,362, filed Feb. 4, 2008, entitled
"Dispenser and Apparatus and Method for Filling a Dispenser," which
is a continuation of similarly-titled U.S. application Ser. No.
11/349,873, filed Feb. 8, 2006, which is a continuation of
similarly-titled U.S. application Ser. No. 10/843,902, filed May
12, 2004, now U.S. Pat. No. 6,997,219, issued Feb. 14, 2006; U.S.
application Ser. No. 11/938,103, filed Nov. 9, 2007, entitled
"Device with Chamber and First and Second Valves in Communication
Therewith, and Related Method," which is a divisional of U.S.
application Ser. No. 10/976,349, filed Oct. 28, 2004, titled
"Container and Valve Assembly for Storing and Dispensing
Substances, and Related Method."
[0081] In addition, the device may include any desired number of
sealed empty chambers, including, for example, a first chamber for
receiving one or more first liquid components, and a second chamber
for receiving one or more second liquid components. In some such
embodiments, the first and second chambers are initially sealed
with respect to each other to maintain the first and second liquid
components separate from each other during, for example, the shelf
life of the product. Then, when the product is ready to be
dispensed or used, the container includes a mechanism to allow the
first and second chambers to be placed in fluid communication with
each other to allow mixing of the first and second liquid
components at the time of use, or shortly before use. Exemplary
devices that may be used in connection with the methods and
apparatus of the present invention include those described in the
following patent applications, which are hereby incorporated by
reference in their entireties as part of the present disclosure:
U.S. Provisional Patent Application Ser. No. 60/983,153, filed Oct.
26, 2007, entitled "Ready to Feed Container with Drinking Dispenser
and Sealing Member, and Related Method;" U.S. patent application
Ser. No. 11/339,966, filed Jan. 25, 2006, entitled "Container
Closure With Overlying Needle Penetrable And Thermally Resealable
Portion And Underlying Portion Compatible With Fat Containing
Liquid Product, And Related Method;" U.S. patent application Ser.
No. 11/786,206, filed on Apr. 10, 2007, entitled "Ready to Drink
Container with Nipple and Laser Resealable Portion, and Related
Method," which claims priority to similarly-titled U.S. Provisional
Patent Application Ser. No. 60/790,684, filed Apr. 10, 2006; U.S.
Provisional Patent Application Ser. No. 60/981,107, filed Oct. 11,
2007, entitled "Container Having a Closure and Removable Resealable
Stopper for Sealing a Substance Therein and Related Method."
[0082] Furthermore, the devices and methods may be used to store
and dispense any of numerous different products or substances,
including without limitation, food products, such as low acid food
products, dairy, milk-based, soy-based, water-based, juice-based or
other food products, and pharmaceutical, ophthalmic,
dermatological, and vaccine products, and industrial products, such
as paints, adhesives, and components of the foregoing products.
Although the devices and methods disclosed herein are particularly
suited for storing and dispensing sterile products that should be
maintained sterile and hermetically sealed with respect to ambient
atmosphere during storage and throughout the period of dispensing
product from the device, they equally may be used with other
products that are not sterile, or that do not require that the
product be hermetically sealed with respect to ambient
atmosphere.
[0083] Accordingly, this detailed description of the currently
preferred embodiments is to be taken in an illustrative as opposed
to a limiting sense.
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