U.S. patent application number 16/572879 was filed with the patent office on 2020-01-09 for device with co-extruded body and flexible inner bladder and related apparatus and method.
The applicant listed for this patent is Dr. Py Institute LLC. Invention is credited to Daniel Py.
Application Number | 20200010251 16/572879 |
Document ID | / |
Family ID | 42097969 |
Filed Date | 2020-01-09 |
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United States Patent
Application |
20200010251 |
Kind Code |
A1 |
Py; Daniel |
January 9, 2020 |
DEVICE WITH CO-EXTRUDED BODY AND FLEXIBLE INNER BLADDER AND RELATED
APPARATUS AND METHOD
Abstract
A device comprises a first portion including a first polymer,
and a second portion that is relatively flexible in comparison to
the first portion and includes a second polymer that is
substantially not bondable to the first polymer. A chamber of the
device is hermetically sealable with respect to ambient atmosphere
and is defined by (i) an interior of the second portion, and/or
(ii) a space formed between the first and second portions. A third
portion of the device includes a third polymer that is bondable to
the first and second polymers and fixedly secures the first and
second portions to each other.
Inventors: |
Py; Daniel; (Larchmont,
NY) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Dr. Py Institute LLC |
New Milford |
CT |
US |
|
|
Family ID: |
42097969 |
Appl. No.: |
16/572879 |
Filed: |
September 17, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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15608864 |
May 30, 2017 |
10414559 |
|
|
16572879 |
|
|
|
|
14930896 |
Nov 3, 2015 |
9663274 |
|
|
15608864 |
|
|
|
|
13847277 |
Mar 19, 2013 |
9211983 |
|
|
14930896 |
|
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|
|
12577126 |
Oct 9, 2009 |
8397950 |
|
|
13847277 |
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61104613 |
Oct 10, 2008 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
B65D 23/02 20130101;
B29C 48/21 20190201; B29C 48/08 20190201; B29C 48/09 20190201; B29L
2009/00 20130101; B29C 48/10 20190201; B65D 47/32 20130101; B65D
47/205 20130101; B29L 2031/7158 20130101; B65D 47/24 20130101; B29C
48/23 20190201; B05B 11/3028 20130101; B29C 49/04 20130101 |
International
Class: |
B65D 47/24 20060101
B65D047/24; B29C 48/09 20060101 B29C048/09; B65D 47/32 20060101
B65D047/32; B65D 23/02 20060101 B65D023/02; B05B 11/00 20060101
B05B011/00; B65D 47/20 20060101 B65D047/20 |
Claims
1. A device comprising: a first portion including a first polymer;
a second portion that is relatively flexible in comparison to the
first portion including a second polymer that is substantially not
bondable to the first polymer, and a chamber that is hermetically
sealable with respect to ambient atmosphere and defined by at least
one of (i) an interior of the second portion, and (ii) a space
formed between the first and second portions; and a third portion
including a third polymer that is bondable to the first and second
polymers and that fixedly secures the first and second portions to
each other.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This patent application is a continuation claiming the
benefit under 35 U.S.C. .sctn. 120 of similarly-titled U.S. patent
application Ser. No. 15/608,864, filed May 30, 2017, which is a
continuation of U.S. patent application Ser. No. 14/930,896, filed
Nov. 3, 2015, now U.S. Pat. No. 9,663,274 issued May 30, 2017,
which is a continuation of U.S. patent application Ser. No.
13/847,277, filed Mar. 19, 2013, now U.S. Pat. No. 9,211,983 issued
Dec. 15, 2015, which is a continuation of U.S. patent application
Ser. No. 12/577,126, filed Oct. 9, 2009, now U.S. Pat. No.
8,397,950 issued Mar. 19, 2013, which claims the benefit under 35
U.S.C. .sctn. 119(e) of U.S. Provisional Patent Application No.
61/104,613, filed Oct. 10, 2008, entitled "Device with Co-Extruded
Body and Flexible Inner Bladder and Related Apparatus and Method,"
all of which are hereby incorporated by reference in their entirety
as part of the present disclosure.
BACKGROUND OF THE INVENTION
Field of the Invention
[0002] The present invention relates to devices, such as
containers, defining variable-volume storage chambers and methods
of making such devices, and more particularly, to such devices with
co-extruded outer bodies and inner bladders and to related
methods.
Background Information
[0003] One of the drawbacks of current devices for storing
products, such as food or medicinal products, is that the 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 that the products be sterile filled and/or maintained
sealed with respect to ambient atmosphere during storage and/or use
of the device. For example, in devices including flexible bladders
defining variable-volume storage chambers and relatively rigid
outer bodies or housings, the bladders are formed separately from
the outer bodies, and the bladders are filled, or otherwise
assembled to the outer bodies and then filled. These multiple
assembly steps can be time consuming and expensive and can subject
the various parts to contamination.
[0004] 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
[0005] In accordance with a first aspect, the present invention is
directed to a device comprising a first portion including a first
polymer, and a second portion that is relatively flexible in
comparison to the first portion and includes a second polymer that
is substantially not bondable to the first polymer. A chamber of
the device is hermetically sealable with respect to ambient
atmosphere and is defined by (i) an interior of the second portion,
and/or (ii) a space formed between the first and second portions. A
third portion of the device includes a third polymer that is
bondable to the first and second polymers and fixedly secures the
first and second portions to each other.
[0006] In some embodiments of the present invention, the first
polymer includes first and second monomers, the second polymer
includes third and fourth monomers that are different than the
first and second monomers and substantially not bondable thereto,
and the third polymer includes fifth and sixth monomers. The fifth
monomer is at least substantially similar and bondable to the first
and/or second monomers for bonding the third polymer to the first
polymer, and the sixth monomer is at least substantially similar
and bondable to the third and/or fourth monomers for bonding the
third polymer to the second polymer. In some such embodiments, the
fifth monomer is the same as or substantially the same as the first
and/or second monomers, and the sixth monomer is the same as or
substantially the same as the third and/or fourth monomers.
[0007] In some embodiments of the present invention, the first,
second and third portions are co-extruded. In some such
embodiments, the first, second and third portions are co-extrusion
blow-molded. In some embodiments of the present invention, the
first portion defines a relatively rigid outer body, the second
portion defines a relatively flexible inner bladder, and the third
portion fixedly secures the outer body and/or the inner bladder to
the other.
[0008] In some embodiments of the present invention, the chamber is
a variable-volume storage chamber, and the device further comprises
a one-way valve fixedly secured to the first, second and/or third
portions of the device and in fluid communication with the chamber.
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 substance to flow out
of the chamber and device 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.
[0009] In some embodiments of the present invention, 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. In some such
embodiments, the flexible valve member defines a normally closed
axially-extending valve opening. Preferably, the one-way valve
further includes a relatively rigid valve seat that engages the
flexible valve member in the normally closed position and defines
the normally closed axially-extending valve opening
therebetween.
[0010] In some embodiments of the present invention, the one-way
valve includes a valve member formed of an elastic material and
including an axially-extending valve portion forming a normally
closed, axially-extending valve opening. The valve portion is
movable radially between a normally closed position, and an open
position with at least a segment of the valve portion spaced
radially away from the closed position to connect the valve opening
in fluid communication with the variable-volume chamber, and
thereby allow the passage of fluid from the variable-volume chamber
through the valve opening.
[0011] In some embodiments of the present invention, the device
further comprises a pump coupled between the variable-volume
chamber and the one-way valve for pumping substance from the
chamber through the one-way valve. In some such embodiments, the
pump is configured to pump discrete portions of substance from the
chamber through the one-way valve. During pumping, the one-way
valve and chamber maintain any remaining substance in the chamber
in an aseptic condition and sealed with respect to ambient
atmosphere.
[0012] In some embodiments of the present invention, the pump
includes a compression chamber, a compressive surface receivable
within the compression chamber, and a manually-engageable actuator
coupled to the compression chamber and/or compressive surface. The
compressive surface and/or compression chamber is movable relative
to the other by the manually-engageable actuator between (i) a rest
position, and (ii) at least one actuated position for pressurizing
fluid within the compression chamber and, in turn, dispensing fluid
through the one-way valve. In some such embodiments, the
compressive surface and/or compression chamber is movable relative
to the other by the manually-engageable actuator between (i) a
first position with the compression chamber coupled in fluid
communication with the variable-volume chamber for receiving fluid
from the variable-volume chamber into the compression chamber, and
(ii) a second position with the compressive surface received within
the compression chamber, and the compression chamber substantially
sealed with respect to the variable-volume chamber to pressurize
fluid within the compression chamber and, in turn, dispense
pressurized fluid through the one-way valve. In some such
embodiments, a flexible member defines on one side thereof the
manually-engageable actuator, and defines on another side thereof
the compressive surface. In some such embodiments, the flexible
member is substantially dome shaped, and the compression chamber is
defined by a recess opposing the substantially dome-shaped flexible
member.
[0013] In some embodiments of the present invention, the pump is
co-molded with the one-way valve. In some such embodiments, the
pump and one-way valve form a pump and valve assembly including a
base defining a valve seat, a relatively flexible
manually-engageable actuator for pumping substance through the
one-way valve, and a relatively flexible valve member engaging the
valve seat and forming a normally closed valve opening
therebetween. In some such embodiments, the pump and valve assembly
further comprises (i) a penetrable and laser resealable portion,
and/or (ii) a one-way filling valve for filling the variable-volume
chamber.
[0014] In some embodiments of the present invention, the penetrable
and laser resealable portion and/or the one-way filling valve is
co-molded with the pump and valve assembly. In some such
embodiments, the pump and valve assembly includes a support surface
formed integral with the base and movable relative thereto. The
manually-engageable actuator and valve member are co-molded to the
support surface. The support surface is movable into engagement
with the base to fixedly secure the support surface to the base and
form a fluid-tight seal, and to place the valve member in
engagement with the valve seat forming the normally closed valve
opening. Preferably, a flexible gasket is formed on the base and
engageable between the base and the body to form a fluid-tight
seal. In some such embodiments, the gasket is co-molded with the
manually-engageable actuator and valve member. In some embodiments
of the present invention, the pump and valve assembly further
includes an integral or living hinge extending between the support
and base for allowing movement of at least one relative to the
other.
[0015] In some embodiments of the present invention, at least a
portion of the pump, the one-way valve, and/or a surface defining
the variable-volume chamber is penetrable by an injection member
for filling the variable-volume chamber through the injection
member with a fluid to be stored therein, and the resulting
penetration aperture is thermally resealable such as by applying
laser energy thereto.
[0016] In accordance with another aspect, the present invention is
directed to a device comprising first means for forming an outer
surface of the device and including a first polymer. Second means
of the device includes a second polymer that is substantially not
bondable to the first polymer for forming a relatively flexible
inner surface of the device in comparison to the first means, and a
chamber that is hermetically sealable with respect to ambient
atmosphere and defined by (i) an interior of the second means,
and/or (ii) a space formed between the first and second means.
Third means of the device includes a third polymer that is bondable
to the first and second polymers for fixedly securing the first and
second means to each other. In some embodiments of the present
invention, the first means is a relatively rigid outer body, the
second means is a relatively flexible inner bladder, and the third
means is a portion of the device that is bonded to and fixedly
secures the body and/or bladder to the other. Preferably, the body,
bladder and portion bonded thereto are co-extrusion blow
molded.
[0017] In accordance with another aspect, the present invention is
directed to a method comprising the following steps:
[0018] (i) extruding a first portion of a device including a first
polymer;
[0019] (ii) co-extruding with the first portion a second portion of
the device that is relatively flexible in comparison to the first
portion, and that includes a second polymer that is substantially
not bondable to the first polymer;
[0020] (iii) co-extruding a third portion of the device including a
third polymer that is bondable to the first and second polymers;
and
[0021] (iv) bonding the third portion to the first and second
portions to fixedly secure the first and second portions to the
third portion, and forming a chamber that is hermetically sealable
with respect to ambient atmosphere defined by (i) an interior of
the second portion, and/or (ii) a space formed between the first
and second portions.
[0022] Some embodiments of the present invention further comprise
co-extrusion blow molding the first, second and third portions.
Some such embodiments further comprise substantially simultaneously
co-extruding the first and second polymers, sequentially
co-extruding the third polymer and, in turn, bonding the third
polymer to the first and second polymers to fixedly secure the
first, second and third portions to each other. Some such
embodiments further comprise extruding a first parison of the first
polymer, co-extruding a second parison of the second polymer within
the first parison, sequentially co-extruding a third parison of the
third polymer, and bonding the third polymer to each of the first
and second polymers.
[0023] Some embodiments of the present invention further comprise
co-molding a pump and one-way dispensing valve assembly, and
fixedly securing the pump and one-way dispensing valve assembly to
the first, second and/or third portions. The one-way dispensing
valve is in fluid communication with the variable-volume chamber,
and the variable-volume chamber is hermetically sealed with respect
to ambient atmosphere.
[0024] In some embodiments of the present invention, the co-molding
step includes co-molding as part of the pump and valve assembly (i)
a penetrable and thermally resealable portion, and/or (ii) a
one-way filling valve. In some such embodiments, the co-molding
step includes co-molding as part of the pump and valve assembly a
penetrable and thermally resealable portion. In these embodiments,
the aseptic filling step includes penetrating the penetrable and
thermally resealable portion with an injection member placed in
fluid communication with the variable-volume chamber, filling the
variable-volume chamber through the injection member, withdrawing
the injection member, and thermally resealing, such as by applying
laser energy to, a resulting penetration aperture formed in the
penetrable and thermally resealable portion.
[0025] In some embodiments of the present invention, the co-molding
step includes co-molding as part of the pump and valve assembly a
one-way filling valve in fluid communication with the
variable-volume chamber. In these embodiments, the aseptic filling
step includes placing a filling member in fluid communication with
an inlet of the one-way filling valve; filling the sterile fluid
through the filling member and one-way filling valve and into the
variable-volume chamber; removing the filling member from the
one-way filling valve; and sealing the variable-volume chamber with
respect to ambient atmosphere with the one-way filling valve.
[0026] Some embodiments of the present invention further comprise
forming a sealed, empty, sterile variable-volume chamber. In some
such embodiments, the step of forming a sterile variable-volume
chamber includes subjecting the sealed, empty, variable-volume
chamber to radiation. In some such embodiments, the radiation is
gamma radiation. Some embodiments of the present invention comprise
the steps of co-molding the pump and valve assembly or other device
closure; co-extruding the first, second and third portions of the
device, such as the relatively rigid outer body, flexible inner
bladder, and neck; upon molding the two parts, promptly assembling
the closure to the neck in an aseptic environment, such as under an
overpressure of sterile air, and thereby forming a sealed, empty,
sterile variable-volume chamber. Some embodiments of the present
invention further comprise aseptically filling the sealed, empty,
variable-volume chamber with a sterile fluid.
[0027] One advantage of the device and method of the present
invention is that the first portion, such as the outer body of the
container or other device, and the second portion, such as the
inner bladder of the container or other device, 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 pump and
valve assembly, and/or the pump, penetrable and thermally
resealable stopper or filling valve, and dispensing valve assembly,
can be co-molded in one part, and attached to the outer body and
flexible inner bladder, thus forming such device in approximately
two parts.
[0028] 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
[0029] FIGS. 1A, 1B and 1C are somewhat schematic, partial
cross-sectional views of a device embodying the present invention,
including a relatively rigid outer body, a flexible inner bladder
defining a variable-volume storage chamber, and a neck, that are
co-extrusion blow molded as one part, and showing in FIG. 1A the
filled inner bladder, in FIG. 1B the inner bladder with a portion
of the stored fluid dispensed therefrom, and in FIG. 1C the empty
bladder after substantially all of the fluid is dispensed
therefrom;
[0030] FIG. 2 is a somewhat schematic, cross-sectional view of the
device of FIGS. 1A, 1B, and 1C including a pump and dispensing
valve assembly fixedly secured to the neck and forming a
fluid-tight seal therebetween for pumping discrete portions of
fluid through the one-way valve, and maintaining the fluid
remaining in the variable-volume storage chamber sealed with
respect to the ambient atmosphere;
[0031] FIG. 3 is a top plan view of an open pump and valve assembly
in an embodiment of an invention prior to assembly to the neck
including a co-molded pump, dispensing valve, and needle penetrable
and laser resealable stopper for needle filling the variable-volume
storage chamber, and laser resealing the resulting needle aperture
to seal the variable-volume storage chamber with respect to the
ambient atmosphere;
[0032] FIG. 4 is a somewhat schematic, elevational view of an
assembled device using the pump and valve assembly of FIG. 3 in an
embodiment of the invention; and
[0033] FIG. 5 is a top view of the assembled device of FIG. 4.
DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION
[0034] In FIGS. 1A, 1B and 1C, a device embodying the present
invention is indicated generally by the reference numeral 10. The
device 10 includes a first portion or relatively rigid outer body
12 including a first polymer, and a second portion or relatively
flexible inner bladder 14 that is relatively flexible in comparison
to the outer body, and includes a second polymer that is
substantially not bondable to the first polymer. A chamber 16 of
the device is hermetically sealable with respect to ambient
atmosphere and is defined by an interior of the inner bladder 14.
Alternatively, if desired, the chamber 16 may be defined by a space
formed between the first and second portions 12 and 14,
respectively, such as a space 26 formed between the flexible inner
bladder 14 and outer body 12. A third portion 18 of the device 10
defines a neck of the container that fixedly secures the outer body
12 and flexible inner bladder 14 to each other. The neck 18
includes a third polymer that is bondable to the first and second
polymers to fixedly secure the outer body 12 and flexible inner
bladder 14 to each other. As described further below, in the
illustrated embodiments of the invention, the first, second and
third portions 12, 14 and 18, respectively, are co-extruded, and
preferably are co-extrusion blow-molded.
[0035] In the illustrated embodiments, the first polymer forming
the outer body 12 includes first and second monomers, the second
polymer forming the flexible inner bladder 14 includes third and
fourth monomers that are different than the first and second
monomers and substantially not bondable thereto, and the third
polymer forming the neck 18 includes fifth and sixth monomers. The
fifth monomer is at least substantially similar and bondable to the
first and/or second monomers for bonding the third polymer/neck 18
to the first polymer/outer body 12, and the sixth monomer is at
least substantially similar and bondable to the third and/or fourth
monomers for bonding the third polymer/neck 18 to the second
polymer/flexible inner bladder 14. In the illustrated embodiment,
the fifth monomer is the same as or substantially the same as the
first and/or second monomers, and the sixth monomer is the same as
or substantially the same as the third and/or fourth monomers. As
may be recognized by those of ordinary skill in the pertinent art
based on the teachings herein, the first, second and third
polymers, 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.
Further, 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. In the exemplary
illustrated embodiment, the outer body 12 may be relatively rigid
in comparison to the flexible inner bladder 14, but nevertheless
may be manually squeezable to pressurize the inner bladder 14 and,
in turn, pressure the fluid or other substance within the
variable-volume chamber to dispense fluid or other substance
therefrom.
[0036] As shown in FIGS. 1A-1C, the outer body 12 defines a
relatively rigid base 20 that is co-molded with, and fixedly
engages a base portion 22 of the flexible inner bladder 14 to
fixedly secure the base of the bladder to the base of the outer
body, and to form a fluid tight seal at the base of the inner
bladder. The base 20 of the outer body 12 further defines a fluid
flow aperture 24 that extends through the base and is in fluid
communication with the second variable-volume chamber 26 located
between the flexible inner bladder 14 and relatively rigid outer
body 12. The fluid flow aperture 24 allows fluid, such as air, to
flow from the ambient atmosphere into the second variable-volume
chamber 26 to accommodate changes in volume in the first
variable-volume chamber 16, for example, after dispensing fluid
therefrom. In the illustrated embodiment, the fluid flow aperture
24 is in the nature of a pin hole; however, as may be recognized by
those of ordinary skill in the pertinent art based on the teachings
herein, the fluid-flow aperture 24 may take any of numerous
different configurations that are currently known, or that later
become known. For example, if desired, the fluid-flow aperture 24
may include within it or otherwise be defined as a one-way valve,
such as an air check valve, that allows air to flow into the second
variable-volume chamber 26 as fluid is dispensed from the first
variable-volume chamber 16. In one such embodiment, the check valve
allows the air in the second variable-volume chamber 26 to become
pressurized upon manually squeezing the outer body 12 to, in turn,
pressurize the fluid or other substance in the first
variable-volume chamber 16 and, for example, facilitate dispensing
such fluid or other substance.
[0037] Also in the illustrated embodiments, the chamber 16 is a
variable-volume storage chamber, and as shown in FIGS. 2 through 4,
the device 10 further comprises a one-way dispensing valve 28
fixedly secured to the neck 18 and in fluid communication with the
first variable-volume chamber 16. The one-way valve 28 defines a
normally closed position that hermetically seals the first
variable-volume chamber 16 with respect to the ambient atmosphere,
and an open position that allows substance to flow out of the
chamber 16 and device through the one-way valve 28. Preferably,
such as in the application of the device for food products, such as
sterile foods, or medicinal products, the one-way valve 28
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).
[0038] As shown in FIG. 3, the one-way valve 28 includes a flexible
valve member 30 that is movable from the closed to the open
position in response to substance at an inlet 32 to the one-way
valve exceeding a valve opening pressure. The one-way valve 28
includes a relatively rigid valve seat 34 that engages the flexible
valve member 30 in the normally closed position, and defines a
normally closed axially-extending valve opening 36 therebetween.
The valve member 30 is formed of an elastic material and includes
an axially-extending valve portion 38 forming the normally closed,
axially-extending valve opening 36. The valve portion 38 is movable
radially between a normally closed position, and an open position
with at least a segment of the valve portion 38 spaced radially
away from the closed position to connect the valve opening 36 in
fluid communication with the variable-volume chamber 16, and
thereby allow the passage of fluid from the variable-volume chamber
16 through the valve opening 36.
[0039] The device 10 further comprises a pump 40 coupled between
the variable-volume chamber 16 and the one-way valve 28 for pumping
substance from the chamber 16 through the one-way valve 28. The
pump 40 is configured to pump discrete portions of substance from
the chamber 16 through the one-way valve 28. During pumping, the
one-way valve 28 and chamber 16 maintain any remaining substance in
the chamber in an aseptic condition and sealed with respect to
ambient atmosphere.
[0040] As shown in FIGS. 2 and 3, the pump 40 includes a
compression chamber 42, a compressive surface 44 receivable within
the compression chamber 42, and a manually-engageable actuator 46
overlying the compressive surface 44 in fluid communication with
the compression chamber. The compressive surface 44 and/or
compression chamber 42 is movable relative to the other by the
manually-engageable actuator 46 between (i) a rest position, as
shown typically in FIG. 4, and (ii) at least one actuated position
for pressurizing fluid within the compression chamber 42 and, in
turn, dispensing fluid through the one-way valve 28. In the
illustrated embodiment, the compressive surface 44 and/or
compression chamber 42 is movable relative to the other by the
manually-engageable actuator 46 between (i) a first position, as
shown typically in FIG. 4, with the compression chamber 42 coupled
in fluid communication with the variable-volume chamber 16 for
receiving fluid from the variable-volume chamber into the
compression chamber, and (ii) a second position (not shown) with
the compressive surface 44 received within the compression chamber
42 to pressurize fluid within the compression chamber and, in turn,
dispense pressurized fluid through the one-way valve 28. In the
illustrated embodiment, a flexible, substantially dome-shaped
member defines on one side thereof the manually-engageable actuator
46, and defines on opposite side thereof the compressive surface
44, and the compression chamber 42 is defined by a recess opposing
the substantially dome-shaped flexible member.
[0041] Also in the illustrated embodiments, the pump 40 is
co-molded with the one-way valve 28. As shown in FIG. 3, the pump
and one-way valve form a pump and valve assembly 48 including a
base 50 defining the valve seat 34, and an inlet opening 52 in
fluid communication between the compression chamber 42 of the pump
and the variable-volume chamber 16. The inlet opening 52 may have
an inlet 64 in fluid communication with the variable volume storage
chamber. The pump and valve assembly 48 further comprises a support
54 that is co-molded with the base 50, and a flexible hinge 56 (or
"living hinge") extending between the support 54 and base 50 that
allows the support 54 to be folded over the base and fixedly
secured thereto to assemble the pump and valve assembly. The
support may further have a seal 66 in register with the inlet 64.
The support 54 includes molded thereon the relatively flexible
manually-engageable actuator 46 and underlying compressive surface
44 for pumping substance through the one-way valve, and the
relatively flexible valve member 30 that engages the valve seat 34
when the support 54 is folded over and assembled to the base 50
forming an interference fit therebetween and defining the normally
closed valve opening 36.
[0042] The pump and valve assembly 48 further comprises a
penetrable and thermally resealable portion 58 that is co-molded to
the support 54 and overlies an aperture 60 in the base 50 when
attached thereto. The penetrable and thermally resealable portion
58 allows filling therethrough of the variable-volume chamber 16
with a needle or like injection member, and thermal resealing of
the resulting penetration aperture, such as by applying laser
radiation thereto.
[0043] As show in FIGS. 3, 4 and 5, the support 54 is movable into
engagement with the base 50 to fixedly secure the support to the
base and form a fluid-tight seal therebetween (i.e., the base of
the dome-shaped actuator engages the surface defining the
corresponding inlet aperture 52, and the needle penetrable and
thermally resealable portion 58 engages the surface defining the
corresponding aperture 60 to form fluid-tight seals therebetween),
and to place the valve member 30 in engagement with the valve seat
34 and form the normally closed valve opening 36 therebetween.
Further, seal 66 is placed into register with the inlet 64 so as to
seal the compression chamber 42 with respect to the variable volume
storage chamber 16 during pressurization of the fluid in the
compression chamber 42. The seal 66 is of a material, as would be
known to those in the art, so as to be sufficiently displaceable
from the inlet 64 so fluid may be received from the variable-volume
chamber 16 into the compression chamber 42. As shown in FIG. 3, a
flexible gasket 62 is formed on the base 50 and is engageable
between the base and the neck 18 to form a fluid-tight seal
therebetween. In the illustrated embodiment, the gasket 62 is
co-molded with the manually-engageable actuator 46, valve member 30
and needle penetrable and thermally resealable portion 58. However,
as may be recognized by those of ordinary skill in the pertinent
art based on the teachings herein, these components can be molded
separately and then assembled, or otherwise formed in any of
numerous different ways that are currently known, or that later
become known.
[0044] The currently preferred embodiment of the device 10 is
manufactured in accordance with the following steps:
[0045] (i) extruding the first portion or body 12 that includes the
first polymer;
[0046] (ii) co-extruding with the first portion or body 12 the
second portion or flexible inner bladder 14 that includes the
second polymer that is substantially not bondable to the first
polymer;
[0047] (iii) co-extruding the third portion or neck 18 that
includes the third polymer that is bondable to the first and second
polymers; and
[0048] (iv) bonding the third portion or neck 18 to the first and
second portions or body and flexible inner bladder 12 and 14,
respectively, to fixedly secure the body and inner bladder to the
neck.
[0049] In the illustrated embodiment, the body 12, bladder 14 and
neck 18 are co-extrusion blow molded. Preferably, the method of
manufacture involves substantially simultaneously co-extruding the
first and second polymers, sequentially co-extruding the third
polymer and, in turn, bonding the third polymer (or neck 18) to the
first and second polymers (or body 12 and inner bladder 14) to
fixedly secure the body, bladder and neck to each other. More
specifically, the method of manufacture includes extruding a first
parison of the first polymer, co-extruding a second parison of the
second polymer within the first parison, sequentially co-extruding
a third parison of the third polymer, and bonding the third polymer
(or neck) to each of the first and second polymers (or body and
bladder).
[0050] As described above, the pump and one-way dispensing valve
assembly 48 is co-molded and fixedly secured to the neck 18 to
thereby form the variable-volume chamber 16 that is hermetically
sealed with respect to ambient atmosphere. Upon assembly, the
one-way dispensing valve 28 is in fluid communication with the
variable-volume chamber 16, and the variable-volume chamber 16 is
hermetically sealed with respect to ambient atmosphere.
[0051] The device defining the sealed, empty, variable-volume
chamber is then sterilized such as by applying gamma radiation
thereto. Alternatively, as described above, the pump and valve
assembly may be assembled to the neck promptly upon molding when
both parts are sterile or substantially sterile due to the heat of
molding. The sterile parts are preferably automatically assembled
promptly upon molding, such as at the time of discharge from the
molds or shortly thereafter, such as with a robot or other
automated assembly device, under an overpressure of sterile air or
other gas to form the device with an empty, sterile,
variable-volume chamber.
[0052] The sealed, empty device defining the sterile
variable-volume chamber then may be aseptically filled. In the
illustrated embodiment, the aseptic filling includes penetrating
the penetrable and thermally resealable portion 58 with an
injection member (not shown) placed in fluid communication with the
variable-volume chamber 16, filling the variable-volume chamber
through the injection member, withdrawing the injection member, and
thermally resealing, such as by applying laser energy to, a
resulting penetration aperture formed in the penetrable and
thermally resealable portion.
[0053] In an alternative embodiment of the invention, rather than
include a penetrable and thermally resealable portion, the pump and
valve assembly 48 includes a valve-in and vent-out assembly
including a one-way filling valve for filling the variable-volume
chamber 16 therethrough, and a one-way venting valve for venting
gas from the variable volume chamber upon filling the fluid or
substance into the variable-volume chamber 16. Preferably, the
valve-in and vent-out assembly is co-molded with the pump and valve
assembly 48 in the same manner, or substantially the same manner
that the penetrable and thermally resealable portion 58 is
co-molded with the pump and valve the assembly.
[0054] In the alternative embodiments including the valve-in and
vent-out assembly, the aseptic filling step includes placing a
filling member in fluid communication with an inlet of the one-way
filling valve; filling the sterile fluid through the filling member
and one-way filling valve and into the variable-volume chamber;
removing the filling member from the one-way filling valve; and
sealing the variable-volume chamber with respect to ambient
atmosphere with the one-way filling valve.
[0055] The one-way valve and pump may take the form of any of
numerous different valves and/or pumps that are currently known, or
that later become known, including any of the one-way valves and/or
pumps that are disclosed in the following patents and patent
applications that are hereby expressly incorporated by reference in
their entireties as part of the present disclosure: U.S. patent
application Ser. No. 11/650,102 filed Jan. 5, 2007, entitled
"One-Way Valve and Apparatus and Method of Using the Valve," which
is a continuation of claims priority to U.S. Provisional
Application No. 60/757,161, filed Jan. 5, 2006, U.S. patent
application Ser. No. 11/868,820 filed Oct. 8, 2007, entitled
"One-Way Valve and Apparatus Using the Valve," which claims
priority to U.S. Provisional Application No. 60/644,130 filed Jan.
14, 2005 and U.S. Provisional Application No. 60/633,322 filed Dec.
4, 2004, U.S. application Ser. No. 11/295,274 filed Dec. 5, 2005,
entitled "One-Way Valve and Apparatus Using the Valve," now U.S.
Pat. No. 7,278,553, which claims priority to U.S. Provisional
Application No. 60/644,130 filed Jan. 14, 2005 and U.S. Provisional
Application No. 60/633,332 filed Dec. 4, 2004, U.S. application
Ser. No. 11/949,104 filed Dec. 3, 2007, entitled "Apparatus for
Dispensing Fluids," which is a division of similarly-titled U.S.
application Ser. No. 11/900,335 filed Sep. 10, 2007, U.S.
application Ser. No. 11/900,332 filed Sep. 10, 2007, entitled
"Method for Dispensing Fluids," which claims priority to U.S.
Provisional Application No. 60/843,131 filed Sep. 8, 2006, U.S.
application Ser. No. 11/900,227 filed Sep. 10, 2007, entitled
"Apparatus for Sealing and Engaging Sterile Chambers," which claims
priority to U.S. Provisional Application No. 60/843,131 filed Sep.
8, 2006, U.S. application Ser. No. 11/351,716 filed Feb. 10, 2006,
entitled "Fluid Dispenser Having a one Way Valve, Pump, Variable
Volume Storage Chamber, and a Needle Penetrable and Laser
Resealable Portion," U.S. application Ser. No. 10/976,349 filed
Oct. 28, 2004, entitled "Container and Valve Assembly for Storing
and Dispensing Substances, and Related Method," and U.S.
application Ser. No. 11/935,194, filed Nov. 5, 2007, entitled
"Dispenser and Method for Storing and Dispensing Sterile Food
Product," now U.S. Pat. No. 7,290,573.
[0056] Similarly, the penetrable and thermally resealable portion
may take the form of any of numerous different penetrable and
thermally resealable portions, that may be formed or otherwise
provided on any portion of the device, and that may be filled with
any of numerous different apparatus or methods that are currently
known, or that later become known, including any apparatus and
methods disclosed in the following patents and patent applications
that are hereby expressly incorporated by reference in their
entireties as part of the present disclosure: U.S. Patent
Application Ser. No. 60/981,107, entitled "Container Having a
Closure and Removable Resealable Stopper for Sealing a Substance
Therein," filed on Oct. 18, 2007; U.S. Patent Application Ser. No.
60/997,675 filed Oct. 4, 2007, entitled "Apparatus and Method for
Formulating and Aseptically Filling Liquid Products;" U.S. patent
application Ser. No. 12/245,678, filed Oct. 3, 2008, entitled
"Apparatus For Formulating And Aseptically Filling Liquid
Products;" U.S. patent application Ser. No. 12/245,681, filed Oct.
3, 2008, entitled "Method For Formulating And Aseptically Filling
Liquid Products;" U.S. patent application Ser. No. 11/408,704 filed
Apr. 21, 2006, now U.S. Pat. No. 7,243,689; 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;" 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. 10/655,455, filed Sep. 3,
2003, entitled "Sealed Containers And Methods Of Making And Filling
Same;" 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.
11/295,251, filed Dec. 5, 2005, entitled "One-Way Valve, Apparatus
and Method of Using the Valve;" U.S. patent application Ser. No.
11/933,272 filed Oct. 31, 2007, entitled "Sealed Containers and
Method 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; U.S. patent application Ser. No. 11/527,775 filed
Sep. 25, 2006 entitled "Sterile Filling Machine Having Needle
Filling Station within E-Beam Chamber," which is a continuation of
similarly-titled U.S. patent application Ser. No. 11/103,803 filed
Apr. 11, 2005, which is a continuation of similarly-titled U.S.
patent application Ser. No. 10/600,525; U.S. patent application
Ser. No. 11/933,300 filed Oct. 31, 2007 entitled "Device with
Needle Penetrable and Laser Resealable Portion and Related Method,"
and U.S. patent application Ser. No. 11/949,087 filed Dec. 3, 2007,
entitled "Device with Needle Penetrable and Laser Resealable
Portion and Related Method."
[0057] The valve-in and vent-out assembly may take the form of any
of numerous different valve-in and valve-out devices that are
currently known, or that later become known, that may be formed or
otherwise provided on any portion of the device, and that may be
filled with any of numerous different apparatus or methods that are
currently known, or that later become known, including any of the
valve-in and valve-out devices, and any of numerous different
apparatus and methods for filling such devices, disclosed in the
patents and patent applications incorporated by reference above and
in following patents and patent applications that are hereby
expressly incorporated by reference in their entireties as part of
the present disclosure: U.S. patent 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. patent application Ser. No. 11/349,873 filed Feb. 8,
2006, which is a continuation of similarly titled U.S. patent
application Ser. No. 10/843,902 filed May 12, 2004; and U.S. patent
application Ser. No. 11/938,103 filed Nov. 9, 2007, entitled
"Container and Valve Assembly for Storing and Dispensing
Substances, and Related Method."
[0058] 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, any of
numerous different materials, including any of numerous different
polymers, may be employed that are currently known, or that later
become known. Similarly, the device may take the form of any of
numerous different devices, including any of numerous different
containers, or containers or other devices with or without valves,
penetrable and thermally resealable portions, and/or pumps, that
are currently known, or that later become known. Further, the
devices and methods of the present invention 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 device and method of the present invention 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. Accordingly, this detailed description of the
currently preferred embodiments is to be taken in an illustrative
as opposed to a limiting sense.
* * * * *