U.S. patent application number 13/482628 was filed with the patent office on 2013-01-03 for flexible mixing bag for mixing solids, liquids, and gases.
This patent application is currently assigned to ATMI BVBA. Invention is credited to Jean-Pascal Zambaux.
Application Number | 20130003488 13/482628 |
Document ID | / |
Family ID | 34423053 |
Filed Date | 2013-01-03 |
United States Patent
Application |
20130003488 |
Kind Code |
A1 |
Zambaux; Jean-Pascal |
January 3, 2013 |
FLEXIBLE MIXING BAG FOR MIXING SOLIDS, LIQUIDS, AND GASES
Abstract
In an embodiment, an apparatus includes a disposable and
flexible mixing tank, configurable as a bag, having a sealed sleeve
therein for arrangement of a mixing device. The volume of the
mixing tank is defined by an inner wall of the mixing tank and an
inner wall of the sleeve. The mixing tank may be used to mix,
store, reconstitute and/or dispense materials therein. Draining of
a mixture may be aided with pressurized gas. Heating or cooling of
the contents of a mixing tank may be accomplished with a thermal
exchange fluid disposed within a thermal exchange vessel and in
thermal communication with the tank.
Inventors: |
Zambaux; Jean-Pascal; (Riom,
FR) |
Assignee: |
ATMI BVBA
HOEGAARDEN
BE
|
Family ID: |
34423053 |
Appl. No.: |
13/482628 |
Filed: |
May 29, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12924897 |
Oct 7, 2010 |
RE43418 |
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13482628 |
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11831735 |
Jul 31, 2007 |
7431494 |
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12924897 |
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10684932 |
Oct 14, 2003 |
7249880 |
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11831735 |
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Current U.S.
Class: |
366/114 |
Current CPC
Class: |
C12M 27/02 20130101;
B01F 7/1695 20130101; B01F 15/00071 20130101; B01F 15/00857
20130101; C12M 23/14 20130101; B01F 15/0085 20130101; C12M 23/28
20130101; B01F 2215/0096 20130101; B01F 2215/0034 20130101; C12M
27/00 20130101; B01F 2215/0014 20130101; B01F 2215/0032 20130101;
B01F 11/02 20130101; B01F 15/00824 20130101 |
Class at
Publication: |
366/114 |
International
Class: |
B01F 11/00 20060101
B01F011/00 |
Claims
1. A mixing container comprising: a plurality of walls bounding an
interior of the mixing container; a flexible sleeve located on or
attached to any wall of the plurality of walls, the sleeve having a
closed end protruding into the interior, and defining a cavity
adapted to receive at least one mixing element, wherein the sleeve
serves as an isolation barrier between the interior and at least
one mixing element when located within the cavity; and at least one
mixing element disposed within the cavity, wherein the at least one
mixing element is arranged to vibrate within the sleeve.
2. The mixing container of claim 1, wherein the at least one mixing
element comprises a piezoelectric actuator.
3. The mixing container of claim 1, wherein the at least one mixing
element comprises an ultrasonic generator.
4. The mixing container of claim 1, wherein the at least one mixing
element comprises a rod or shaft arranged to engage a kinetic
energy source disposed outside the cavity and arranged to cause
movement of the rod or shaft and the sleeve within the
interior.
5. The mixing container of claim 1, wherein the mixing element
comprises a paddle having a widened portion that is wider than a
nominal diameter or width of an associated support rod.
6. The mixing container of claim 5, wherein the support rod is
arranged to engage a kinetic energy source disposed outside the
cavity and arranged to cause movement of the support rod and sleeve
within the interior.
7. The mixing container of claim 1, wherein at least one wall of
the plurality of walls comprises a polymeric film.
8. The mixing container of claim 1, wherein the sleeve comprises a
polymeric film.
9. A mixing container comprising: a plurality of walls bounding an
interior of the mixing container; a flexible sleeve located on or
attached to any wall of the plurality of walls, the sleeve having a
closed end protruding into the interior, and defining a cavity
adapted to receive a vibrating element, wherein the sleeve serves
as an isolation barrier between the interior and a vibrating
element when located within the cavity; and a vibrating element
arranged within the cavity.
10. The mixing container of claim 9, wherein the vibrating element
comprises a piezoelectric actuator.
11. The mixing container of claim 9, wherein the vibrating element
comprises an ultrasonic generator.
12. The mixing container of claim 9, comprising a rod or shaft
within the sleeve and arranged to engage a kinetic energy source
disposed outside the cavity.
13. The mixing container of claim 9, comprising paddle having a
widened portion that is wider than a nominal diameter or width of
an associated support rod, wherein the paddle is arranged within
the sleeve and arranged to engage a kinetic energy source disposed
outside the cavity.
14. The mixing container of claim 9, wherein at least one wall of
the plurality of walls comprises a polymeric film.
15. The mixing container of claim 9, wherein the sleeve comprises a
polymeric film.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. Reissue patent
application Ser. No. 12/924,897 filed on Oct. 7, 2010, and issuing
as U.S. Pat. No. RE43,418 on May 29, 2012, which is a reissue of
U.S. Pat. No. 7,431,494 issued on Oct. 7, 2008 based on U.S. patent
application Ser. No. 11/831,735, filed on Jul. 31, 2007, which in
turn is a continuation of U.S. patent application Ser. No.
10/684,932, filed on Oct. 14, 2003 and issued as U.S. Pat. No.
7,249,880 on Jul. 31, 2007. The disclosures of each of the
foregoing applications and patents is hereby incorporated by
reference herein in their respective entireties for all purposes,
and the priority of each application is hereby claimed under the
provisions of 35 U.S.C. .sctn.120.
TECHNICAL FIELD
[0002] The mixing of components, such as different types of solids,
liquids and/or gases, has a number of applications in different
industries. For example, in the pharmaceutical industry, different
types of drugs are mixed together. In the medical field, body
fluids (such as blood) and/or drugs are typical components that are
mixed. In the semiconductor field, wet solutions are combined with
abrasives to make slurries. The food industry also incorporates
mixing operations into a number of applications. For example, water
is mixed with dehydrated food for the rehydration of such food.
[0003] However, in these and other industries, the components that
are mixed may be hazardous, dangerous, infectious and/or require
high levels of purity. For example, in the pharmaceutical and/or
medical industries, the components that are to be mixed may be
toxic. Additionally, in a number of situations, the handling of
powders may be dangerous because of the possibilities of inhalation
of such powders. In the medical field, individuals that handle body
fluids, such as fluids that are HIV-infected, do so while
attempting to avoid direct contact with these fluids. Furthermore,
in the semiconductor industry, handling of chemicals is avoided to
reduce the potential for forming particulate and introducing
impurities.
[0004] Conventional mixing devices generally involve a glass tank
for components that are of small volumes and a stainless steel tank
for components of larger volumes. These tanks often include a screw
to agitate and maintain powders within suspension. Such screws are
also used to homogenize multiphase solutions. Prior to use, these
mixing tanks must be washed and sterilized. Typically, an autoclave
is used for washing and sterilizing small volume tanks, while a
water steam-based operation is employed for washing and sterilizing
larger volume tanks. When preparing batches of post-etch residue
removers for semiconductor applications, introduction of
contaminants must be excluded at all levels of processing to
decrease particulate formation, which leads to device failure.
These wash, sterilize, and process operations, which are essential
to the specified technologies, are typically time-consuming and
expensive, and require highly qualified individuals for their
performance. Further, periodic maintenance of mixing devices
associated with the various technologies must be performed to
ensure proper operation. In certain cases, washing/sterilizing
operations as well as the maintenance of these mixing devices may
represent more than a third of the total cost of operating and
maintaining such mixing devices, which may be prohibitively
expensive for given applications. Additionally, mixing of
components may cause the pressure to increase within these
conventional mixing devices. If this increased pressure is not
accounted for, then the mixing of such components may become
dangerous, such as the possibility that the tanks could break
apart/explode due to this internal pressure. Moreover, with the use
of many mixing devices currently employed to mix pharmaceuticals,
the displacement of some pharmaceutical outside the mixing device
cannot be eliminated, and therefore the amount of pharmaceutical
remaining inside the mixing device, after mixing, may not be
sufficiently accurate or precisely known. This is problematic when
the FDA requires the administration of such a pharmaceutical in
precise, accurate and known quantities.
[0005] Due to their multiple advantages, disposable containers are
becoming increasingly useful in many industrial applications,
particularly as storage containers.
[0006] In biological processing, there is an ever-increasing need
for disposable products, such as storage bags, which can range in
size from 10 to more than 3,000 liters. Current uses include, among
others, storage of products or components awaiting disposition to
further processing steps such as, for example, purification. Often,
however, the stored products or components are mixtures, which,
over time, may separate out into phases or components. Emulsions
and suspensions, for example, are particularly predisposed to such
phase separations.
[0007] Current industry standards require remixing, regeneration
and/or revalidation of a suspension or emulsion before further
processing can resume. In order for remixing to occur without
removing the contents from a storage bag, a magnetic stir bar is
used. Often, the duration of the regeneration/revalidation step is
up to several hours, and the quality of mixing is not good.
Additionally, such a process is prone to particle generation inside
the bag that contaminates the formulation therein.
[0008] Alternatively, a recirculation loop may be employed to
regenerate mixtures, such as emulsions or suspensions, whereby
liquid separated from the bulk mixture is repeatedly drained from
the foot or base of the storage bag and refilled through the top of
the bag. In addition to being time-consuming, such an alternative
process requires the container to be opened and resealed.
[0009] As noted above, mixing of materials continues to face
challenges in many industrial applications. Therefore, a system
having both storage and mixing capabilities, and that uses
disposable elements, is needed. The system should offer reduced
labor, lower production costs, and improved product quality in
mixing applications.
SUMMARY
[0010] The present invention relates in certain aspects to a
disposable mixing and storage bag. More particularly, certain
aspects of the present invention relate to a disposable bag, useful
for mixing, storing, reconstituting and/or dispensing
materials.
[0011] In one aspect, the invention relates to a mixing apparatus
comprising: a hollow mixing container having at least one interior
wall; a mixing paddle adapted to engage a support rod mechanically
coupleable to receive kinetic energy from a kinetic energy source,
the mixing paddle having at least one widened paddle portion that
is wider than a nominal diameter or cross-sectional width of the
support rod; a coupling guide joined to the mixing container, the
coupling guide defining an aperture sized to permit pivotal
arrangement of the support rod between the kinetic energy source
and the mixing container; an integral sleeve sealingly and
permanently welded proximate the coupling guide aperture to any of
the container and the coupling guide, the sleeve having a closed
end protruding into the interior of the hollow container, having at
least one exterior wall, and defining a cavity containing the
mixing paddle, the cavity having at least one widened cavity
portion disposed about the at least one widened paddle portion; a
drain port associated with the mixing container; and at least one
inlet port associated with the mixing container; wherein (i) the at
least one interior wall of the mixing container and the at least
one exterior wall of the sleeve encloses a volume, (ii) the sleeve
serves as an isolation barrier between the volume and the mixing
paddle, and (iii) the mixing container is adapted to permit
pressure-assisted draining of any contents thereof.
[0012] In another aspect, the invention relates to a mixing method
employing a mixing apparatus including (i) a kinetic energy source,
(ii) a hollow mixing bag having a flexible integral sleeve joined
thereto with a closed end of the sleeve protruding into the mixing
bag, and having an associated drain port and an associated at least
one inlet port, and (iii) a mixing paddle enveloped by the sleeve
and adapted to receive a support rod coupleable to the kinetic
energy source, wherein at least one interior wall of the bag and an
exterior wall of the sleeve defines an interior volume, and the
sleeve serves as an isolation barrier between the interior volume
and the mixing paddle, the method comprising the steps of:
supplying at least two components of a mixture to the interior
volume; engaging the support rod between the kinetic energy source
and the mixing paddle; mixing the at least two components by moving
the enveloped mixing paddle in a closed curvilinear path within the
interior volume without continuous rotation of the support rod
about a longitudinal axis defined by the support rod to combine the
at least two components and form said mixture; supplying
pressurized gas to the container via any inlet port of the at least
one inlet port; and draining at least a portion of said mixture via
said drain port.
[0013] In another aspect, the invention relates to a mixing
apparatus comprising: a hollow mixing container having at least one
interior wall; a mixing paddle adapted to engage a support rod
mechanically coupleable to receive kinetic energy from a kinetic
energy source, the mixing paddle having at least one widened paddle
portion that is wider than a nominal diameter or cross-sectional
width of the support rod; a coupling guide joined to the mixing
container, the coupling guide defining an aperture sized to permit
pivotal arrangement of the support rod between the kinetic energy
source and the mixing container; an integral sleeve sealingly and
permanently welded proximate the coupling guide aperture to any of
the container and the coupling guide, the sleeve having a closed
end protruding into the interior of the hollow container, having at
least one exterior wall, and defining a cavity containing the
mixing paddle, the cavity having at least one widened cavity
portion disposed about the at least one widened paddle portion; a
thermal exchange vessel arranged to contain a thermal exchange
fluid in thermal communication with at least a portion of the
mixing container; and a thermal exchange element disposed in at
least intermittent thermal communication with the thermal exchange
fluid; wherein the at least one interior wall of the mixing
container and the at least one exterior wall of the sleeve encloses
a volume, and the sleeve serves as an isolation barrier between the
volume and the mixing paddle.
[0014] In another aspect, the invention relates to a material
processing method employing a mixing apparatus including (i) a
kinetic energy source, (ii) a hollow mixing bag having a flexible
integral sleeve joined thereto with a closed end of the sleeve
protruding into the mixing bag, and (iii) a mixing paddle enveloped
by the sleeve and adapted to receive a support rod coupleable to
the kinetic energy source, wherein at least one interior wall of
the bag and an exterior wall of the sleeve defines an interior
volume, and the sleeve serves as an isolation barrier between the
interior volume and the mixing paddle, and (iv) a thermal exchange
vessel arranged to contain a thermal exchange fluid in thermal
communication with at least a portion of the mixing container, the
method comprising the steps of: supplying at least two components
of a mixture to the interior volume; engaging the support rod
between the kinetic energy source and the mixing paddle; mixing the
at least two components by moving the enveloped mixing paddle in a
closed curvilinear path within the interior volume without
continuous rotation of the support rod about a longitudinal axis
defined by the support rod to combine the at least two components
and form said mixture; and controlling temperature of said mixture
by altering any of temperature and circulation of said thermal
exchange fluid.
[0015] Other aspects, features and embodiments of the invention
will be more fully apparent from the ensuing disclosure and
appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] Embodiments of the invention may be best understood by
referring to the following description and accompanying drawings,
which illustrate such embodiments. The numbering scheme for the
Figures included herein are such that the leading number for a
given reference number in a Figure is generally associated with the
number of the Figure. For example, a flexible mixing tank 100 can
be depicted in FIG. 1. However, reference numbers are the same for
those elements that are the same across different Figures. In the
drawings:
[0017] FIG. 1 illustrates a perspective view of a disposable mixing
tank, according to one embodiment of the present invention.
[0018] FIG. 2 illustrates a perspective view of the substantially
parallelepiped shaped mixing tank of FIG. 1.
[0019] FIG. 3A illustrates a perspective view, and FIG. 3B
illustrates a perspective view of an expanded portion, of the
substantially cylindrical sealed sleeve 140 of the mixing tank of
FIG. 1.
[0020] FIGS. 4A-4C illustrate perspective views of: a disposable
mixing tank and mixing means arranged separately; mixing means
fully inserted into the disposable mixing tank; and mixing means
partially inserted into the disposable mixing tank, respectively,
according to a further embodiment of the present invention.
[0021] FIG. 5A illustrates a perspective view of sealed sleeve
containing a mixing paddle and an exploded view of a mixing paddle
and mixing shaft; FIG. 5B illustrates the mixing shaft partially
inserted into the paddle-containing sealed sleeve of FIG. 5A; and
FIG. 5C illustrates the mixing shaft fully inserted into
paddle-containing sealed sleeve of FIGS. 5A-5B, all according to a
further embodiment of the present invention.
[0022] FIG. 6 illustrates a side view of a disposable mixing tank
and associated sealed sleeve according to a further embodiment of
the present invention, with the sealed sleeve shown in various
positions of a 360 degree range of motion within the tank.
[0023] FIG. 7 illustrates a perspective view of a sealed
sleeve-containing disposable mixing tank and mixing means supported
by a frame, all according to a further embodiment of the present
invention.
[0024] FIG. 8 illustrates a flow diagram for the steps of a method
for mixing components according to a further embodiment of the
invention.
DETAILED DESCRIPTION
[0025] The present invention is based on an apparatus, method, and
system for mixing solids, liquids and/or gases, having the
potential to reduce labor, lower production costs, and improve
product quality in mixing applications. It allows disposable bags
or tanks to be used to replace permanent mixing tanks in many
laboratory and pilot scale operations, thus eliminating cleaning,
sterilization, and product contamination concerns.
[0026] Embodiments of the invention are described to include a
disposable and flexible mixing tank having a sealed sleeve arranged
therein. The mixing tank and sleeve may be manufactured from any
suitable material. In one embodiment, the mixing tank and sleeve
are made of any suitable material having a property where upon
removal of an extending force, it is capable of substantially
recovering its original size and shape and/or exhibits a
significant retractive force. As such, the mixing tank and sleeve
may be made of any suitable type of stretchable, collapsible,
pliable and/or elastic material. In a preferred embodiment, the
disposable mixing tank is manufactured from a fully transparent
film to allow for visual inspection of the tank's contents before
and after use.
[0027] As used herein, the term "collapsible" refers to a material
that may fold down into a more compact shape.
[0028] As used herein, the term "pliable" refers to a material that
is supple or adjustable enough to bend freely without breaking.
[0029] As used herein, the term "elastic," or "elastomeric" refers
to that property of a material where upon removal of an extending
force, it is capable of substantially recovering its original size
and shape and/or exhibits a significant retractive force.
[0030] As used herein, the term "stretch," or "stretchable" refers
to a material that is either elastic or extensible. That is, the
material is capable of being extended, deformed, or the like,
without breaking, and may or may not significantly retract after
removal of an extending force. In an embodiment, the stretchable
material can optionally be biaxial stretchable.
[0031] As used herein, the term "biaxial stretch" or "biaxial
stretchable" refers to a material having stretchability in two
directions perpendicular to one another, e.g. stretchability in a
machine direction and in a cross machine direction, or in a
longitudinal direction (front to back) and a lateral direction
(side to side).
[0032] The mixing tank and sleeve may be manufactured from any
suitable material. Suitable materials include, e.g., films,
polymers, thermoplastic polymers, homopolymers, copolymers, block
copolymers, graft copolymers, random copolymers, alternating
copolymers, terpolymers, metallocene polymers, nonwoven fabric,
spunbonded fibers, meltblown fibers, polycellulose fibers,
polyester fibers, polyurethane fibers, polyolefin fibers, polyamide
fibers, cotton fibers, copolyester fibers, open cell foam,
polyurethane, polyvinyl chloride, polyethylene, metals, alloys,
fiberglass, glass, plastic (e.g., polyethylene (PE), polypropylene
(PP), polyvinyl chloride (PVC), polyethylene terephtalate (PET),
polyetheretherketone (PEEK) and polytetrafluoroethylene (PTFE) and
polyfluoroalkoxy (PFA) derivates thereof), rubber, and combinations
or mixtures thereof.
[0033] As used herein, the term "film" refers to a thermoplastic
film made using a film extrusion and/or foaming process, such as a
cast film or blown film extrusion process. For the purposes of the
present invention, the term includes nonporous films as well as
microporous films. Films may be vapor permeable or vapor
impermeable, and function as liquid barriers under normal use
conditions.
[0034] As used herein, the term "thermoplastic" refers to
uncrosslinked polymers of a thermally sensitive material, which
flow under the application of heat or pressure.
[0035] As used herein, the term "polymers" includes, but is not
limited to, homopolymers, copolymers, such as for example, block,
graft, random and alternating copolymers, terpolymers, etc. and
blends and modifications thereof. Furthermore, unless otherwise
specifically limited, the term "polymer" shall include all possible
geometrical configurations of the material. These configurations
include, but are not limited to, isotactic, syndiotactic and
atactic symmetries.
[0036] As used herein, the term "metallocene polymers" refers to
those polymer materials that are produced by the polymerization of
at least ethylene using metallocenes or constrained geometry
catalysts, a class of organometallic complexes, as catalysts.
[0037] As used herein, the terms "nonwoven" and "nonwoven web"
refer to fibrous materials and webs of fibrous material, which are
formed without the aid of a textile weaving or knitting
process.
[0038] As used herein, the term "spunbonded fibers" refers to small
diameter fibers, which are formed by extruding molten thermoplastic
material as filaments from a plurality of fine capillaries of a
spinnerette having a circular or other configuration, with the
diameter of the extruded filaments then being rapidly reduced.
[0039] As used herein, the term "meltblown fiber" refers to fibers
formed by extruding a molten thermoplastic material through a
plurality of fine, usually circular, die capillaries as molten
threads or filaments into converging high velocity heated gas
(e.g., air) streams which attenuate the filaments of molten
thermoplastic material to reduce their diameter, which may be to
microfiber diameter (the average microfiber diameter is not greater
than about 100 microns, for example, having an average diameter of
from about 0.5 microns to about 50 microns, more particularly,
microfibers may have an average diameter of from about 4 microns to
about 40 microns).
[0040] References in the specification to "one embodiment", "an
embodiment", "an example embodiment", etc., indicate that the
embodiment described may include a particular feature, structure,
or characteristic, but every embodiment need not necessarily
include the particular feature, structure, or characteristic.
Moreover, such phrases are not necessarily referring to the same
embodiment. Further, when a particular feature, structure, or
characteristic is described in connection with an embodiment, it is
submitted that it is within the knowledge of one skilled in the art
to affect such feature, structure, or characteristic in connection
with other embodiments, whether or not explicitly described.
[0041] Embodiments of the invention include features, methods or
processes embodied within machine-executable instructions provided
by a machine-readable medium. A machine-readable medium includes
any mechanism, which provides (i.e., stores and/or transmits)
information in a form accessible by a machine (e.g., a computer, a
network device, a personal digital assistant, manufacturing tool,
any device with a set of one or more processors, etc.). In an
exemplary embodiment, a machine-readable medium includes volatile
and/or non-volatile media (e.g., read only memory (ROM); random
access memory (RAM); magnetic disk storage media; optical storage
media; flash memory devices; etc.), as well as electrical, optical,
acoustical or other forms of propagated signals (e.g., carrier
waves, infrared signals, digital signals, etc.).
[0042] Such instructions are utilized to cause a general or special
purpose processor, programmed with the instructions, to perform
methods or processes of the embodiments of the invention.
Alternatively, the features or operations of embodiments of the
invention are performed by specific hardware components, which
contain hard-wired logic for performing the operations, or by any
combination of programmed data processing components and specific
hardware components. Embodiments of the invention may be
implemented with or include software, data processing hardware,
data processing system-implemented methods, and various processing
operations, further described herein.
[0043] The disposable mixing tank as described herein provides a
closed system for use in all phases of processing, reconstitution
or revalidation of mixtures. Preferably, the mixing tank is
flexible. The mixing tank may be manufactured from pyrogen free,
sterile materials, to reduce risks associated with cross
contamination. The flexible bag may comprise one or more ports for
filling, spiking, adding and/or draining components to reduce the
amount of human contact with the various components (which may be
hazardous, dangerous and/or infectious) that are to be mixed as
part of and during the mixing of such components.
[0044] The present invention provides a disposable and flexible
mixing tank having a sealed sleeve arranged therein. As a
single-use apparatus, the mixing tank may be used to mix two or
more components, and store any of the two or more components before
or after mixing. Accordingly, the mixing tank may be discarded
after a single use, thereby eliminating washing/sterilizing
operations as well as maintenance associated with conventional
mixing devices. Moreover, as will be described, in one embodiment,
a number of inlet and outlet openings may be further incorporated
into the mixing tank
[0045] FIG. 1 illustrates a perspective view of a disposable mixing
tank, 100, according to one embodiment of the present invention.
The tank is useful for storing and/or mixing liquids, solids,
and/or gases. The tank may have a volume of 5 liters or more, and
be of a collapsible type that assumes a substantially
parallelepiped shape when filled. A support frame 115 may support
the mixing tank 100, to maintain a sufficient tension during
loading of components into the mixing tank as well as during a
mixing step. Mixing tank 100 comprises a bottom wall 110, a top
wall 120, and four lateral walls 130. The mixing tank may further
comprise inlet(s) 160 and optional outlet(s) 170. In particular,
FIG. 1 illustrates a perspective view of a flexible mixing tank
(apparatus/device) that includes a sealed sleeve or compartment
140, which is defined by wall 150. The sealed sleeve may be located
on or attached to any wall of the mixing tank. Preferably, however,
the sealed sleeve is arranged on the upper or top wall and
centrally located.
[0046] The disposable mixing tank 100 may include any number of
inlet openings 160 and outlet opening(s) 170. A more detailed
description of the different components of the mixing tank 100 will
be described below in conjunction with the description of the
various components thereof.
[0047] The flexible mixing tank may be manufactured to assume any
shape and volume when filled. Preferably, the shape of the mixing
tank is cylindrical or parallelepiped and the volume is between 5
and 10,000 liters. More preferably, the volume of the flexible
mixing tank is between about 10 and 3000 liters.
[0048] FIG. 2 illustrates a perspective view of the substantially
parallelepiped shaped mixing tank of FIG. 1. The bottom, top, and
lateral walls, 110, 120 and 130 respectively, having interior
portions, 210, 220 and 230 respectively, and having exterior
portions, 211, 221, 231, respectively, may be of any suitable
thickness readily determined by one skilled in the art. Moreover,
each wall may be manufactured from one or more of the same or
different materials. Moreover, each wall may be manufactured from
one or more of the same or different materials.
[0049] FIGS. 3A and 3B illustrate perspective views of the
substantially cylindrical sealed sleeve 140 of the mixing tank of
FIG. 1, and an expanded portion thereof, respectively. The wall 150
of sealed sleeve 140, having both an interior portion 351, and an
exterior portion 352, respectively, may be manufactured from
materials that are the same as or different from the mixing tank
walls. When the sleeve 140 of FIG. 3A is joined to the tank 100 of
FIG. 2, the interior portions 210, 220, 230 of mixing tank walls
110, 120, 130 and the exterior portion 352 of the sealed sleeve 140
together define an interior volume 180 of mixing tank 100,
configured to house components of a mixture, before or after a
mixing process.
[0050] The sealed sleeve 140 may be of any suitable thickness
readily determined by one skilled in the art. Moreover, the sealed
sleeve, 140, may comprise multiple sections, such as side wall(s)
or a single article of manufacture.
[0051] The sleeve 140, which is preferably flexible, is sealably
coupled to the disposable mixing tank 100at a seam or juncture 190
by any process readily available to one skilled in the art,
including, but not limited to, joining, welding, heat shrinking,
shrink down plastic tubing, or combinations thereof. A sleeve
cavity 353 is defined by the interior portion of sleeve wall 351,
and has length or height and diameter or width dimensions. The
sleeve may be of a regular or irregular shape (i.e., cylindrical
vs. tapered, respectively). Moreover, the sleeve may be form
fitting so as to directly contact an object arranged therein, much
like a hand in a glove.
[0052] The sleeve may define a sealed passageway for insertion or
arrangement of mixing means therein. The mixing means is isolated
from the interior of the mixing tank, by the sleeve wall and hence
does not contact the interior of the tank 180 or components
therein. The mixing means, which when placed in a mixing mode,
serves to mix components in the tank. The mixing means serves to
create turbulence and accomplish mixing while presenting no risk of
contact with the mixture inside the vessel.
[0053] FIGS. 4A-4C illustrate perspective views of a sealed sleeve
140 mixing means 400. As shown by FIG. 4B, the sealed sleeve 140
defines a cavity for arrangement of mixing means 400. According to
one embodiment of the present invention, mixing means 400 comprises
a mixing paddle 410, with an associated coupling means 420 for
coupling to, for example, a shaft of a mixer (not shown).
[0054] As used herein, the term "mixing means" relates to a
mechanical system or components thereof, capable of transferring
energy or motion to the materials housed in the mixing bag. The
mixing means, which is isolated from the interior of the mixing
tank by the exterior sleeve wall, serves to create turbulence and
mixing while presenting no risk of contact with the mixture inside
the vessel. Useful mechanical system components readily insertable
into the sealed sleeve for transfer of energy to the components
include elements such as, but not limited to, piezoelectric
actuators, ultrasonic generators, rotation elements, swaying
elements, blending elements, vibration elements, eductors, stirring
elements, agitation elements, turbine elements, stator/rotor
elements, impellers, helical mixing elements, and vortex
generators. The mechanical system may be portable, or fixed
mounted. Preferably, a component of the mechanical system comprises
a rigid, detachable, support rod or shaft, which is insertable into
the sealed sleeve. The support rod or shaft, having a proximal end
closest to the upper wall 120 of mixing tank 100 and distal end
farthest from upper wall 120 of mixing tank 100, may be enhanced by
additional feature(s) such as paddles and/or blades. Moreover, the
additional feature(s) such as paddle and/or blade, may be form
fitted into the sleeve during a manufacturing process.
[0055] FIGS. 5A-5C illustrate the sealed sleeve 140 of mixing tank
100 and mechanical elements according to a preferred embodiment of
the present invention. A sealed sleeve 140 comprises a paddle 510,
hollow cavity 520, mixing shaft 530, and coupling guide 540. More
specifically, FIG. 5A shows a sealed sleeve 140 having a paddle
type device 510 form fitted therein during a manufacturing step. A
hollow cavity 520 in the interior of sealed sleeve 140 provides for
arrangement and coupling of a shaft- or rod- type component 530 to
the paddle-type device 510. The support rod or shaft 530, having a
proximal end 531 closest to the upper wall 120 of mixing tank 100
and distal end 532 farthest from upper wall 120 of mixing tank 100,
couples to the paddle 510 at distal end 532. Such coupling may be
made by any means readily available to one skilled in the art, at
any time prior to a mixing step in a manufacturing process. The
proximal end of the support rod 530 may couple, for example, to a
mixer motor driver (not shown). The interior of hollow cavity 520
may be defined by the interior wall of the sealed sleeve 140.
Alternatively, the interior of hollow cavity 520 may be defined by
a separate integrated sleeve to provide additional protection
and/or guard against potential punctures from a misfed or faulty
rod or shaft. A coupling guide 540, sealed to the sleeve 140,
serves as a rigid guide for insertion, arrangement and coupling of
the support rod or shaft 530. The paddle-type device 510, support
rod or shaft 530, and coupling guide 540 are preferably rigid, and
may be formed from any material readily available to one skilled in
the art, including, but not limited to, metals, alloys, composites,
ceramics, composition(s) and material(s) described herein, and/or
mixtures thereof. Preferably, the paddle device is absent of any
sharp edges.
[0056] FIG. 5B shows insertion of a support rod 530 through a
coupling guide 540 and into hollow cavity 520, while FIG. 5C shows
the support rod 530 coupled to the paddle 510.
[0057] Preferably, the sealed sleeve is capable of a range of
motion similar to an arm and hand in the glove of a glove or dry
box. In a conventional dry box, the glove, which is preferably form
fitted to the user's arm and hand, couples to the wall of the dry
box, and isolates a user from an interior environment of the box.
Although a portion of the glove contacts the contents in the box,
the user is isolated from contacting the contents of the box by the
glove, while a wide range of mobility is provided to the user's
arm(s) and hand(s).
[0058] FIG. 6 serves to illustrate, a range of motion of a sealed
sleeve 140, having a paddle 600 arranged therein by a form-fitting
means, within a mixing tank 100. The paddle 600 may include one or
more sections of manufacture. The interior portions of the bottom,
top, and lateral tank walls 210, 220, 230 and exterior portion of
the sealed sleeve wall 352 serve to define an interior volume 180
of the mixing tank 100 for housing components of a mixture, whether
before or after a mixing process is performed. The sealed sleeve
140, comprising a paddle 600, moves within the mixing tank 100 at a
nonzero angle A relative to a central vertical axis 375 of the tank
100, through a 360 degree range of motion (represented by dashed
line 360) in a plane parallel to the mixing tank base 110, whereby
through mechanical motion the paddle 600 at least partially
combines the components contained within the interior volume 180 of
the tank 100.
[0059] In one embodiment, the disposable mixing tank may be used
for containment and storage of at least one component of the
mixture, whereby the disposable mixing tank may store at least a
first component for a period of time until at least a second
component is added to the mixing tank for subsequent combining and
mixing with the at least first component. Any of the first and
second components may comprise multiple compositions as in a
mixture or blend, or the first and second components may consist
essentially of single compositions. Each component may be
introduced into the mixing tank by one or more inlet openings.
[0060] In a still further embodiment, the present invention relates
to a method of remixing, regenerating and/or revalidating a
mixture, which over time has separated into two or more phases or
components. The mixture, having been stored in a disposable mixing
tank having a sealed sleeve therein, comprises two or more
components prone to phase separations, including but not limited to
emulsions, blends and suspensions (e.g., biological solutions
comprising plasma, red cells, viruses, etc., or CMP slurries used
in semiconductor manufacturing processes). The sleeve defines a
sealed passageway for insertion or arrangement of mixing means
therein. When the sleeve and mixing means are placed in a mixing
mode, they serve to remix, regenerate, and/or revalidate the
mixture in the mixing tank. Advantageously, the present invention
serves to reduce the time required to regenerate a mixture because
there is no downtime due to revalidation, as no transfer of
materials is required.
[0061] In a further embodiment, the present invention relates to a
kit including a disposable and collapsible tank having a sealed and
collapsible sleeve disposed therein. The collapsible tank, having a
storage/containment area defined by an interior wall of the
collapsible tank and an exterior wall of the sleeve, is configured
to house components prior to, during, and/or after a mixing
process. The collapsible sleeve defines a sealed passageway for
insertion or arrangement of mixing means therein. The mixing means
is isolated from the interior of the mixing tank by the exterior
sleeve wall, and hence does not contact the interior of the tank or
components therein. The mixing means, when placed in a mixing mode,
serves to mix components within the mixing tank. Preferably, the
flexible sleeve includes a mixing rod shaft or other mixing
components prearranged therein during a manufacturing process. The
kit may further include packaging material and instructions or
indicia located on the packaging material or inside the packaging
material, and may optionally include ancillary components such as
couplers, connectors and filters.
[0062] The figures shown herein thus far illustrate various
embodiments of the disposable mixing tank in accordance with
embodiments of the invention. However, it should be understood that
the invention could be performed by embodiments of systems and
apparatus other than those discussed with reference to the figures,
and embodiments discussed with reference to the systems/apparatus
could perform operations different than those discussed with
reference to the figures.
[0063] A more detailed description of the different components of
the disposable and flexible mixing tank 100 of FIG. 1 will now be
described.
[0064] The tank walls 110, 120, 130 and sleeve walls 150 may be any
type of flexible material for providing a flexible mixing apparatus
(e.g., different types of plastics). For example, the walls 110,
120, 130, 150 may comprise heat-welded plastic films. In one
embodiment, the walls 110, 120, 130, 150 are plastic films with a
thickness in range of 5 microns to 500 microns (depending on the
type of application). While the walls 110, 120, 130, 150 may be
made from a number of different plastics, in one embodiment, the
walls 110, 120, 130, 150 are made from a plastic that includes at
least one material from the following group: polyethylene (PE),
polypropylene (PP), polyvinyl chloride (PVC), polyethylene
terephtalate (PET), polyetheretherketone (PEEK)
polytetrafluoroethylene (PTFE) and polyfluoroalkoxy (PFA) derivates
thereof. In a preferred embodiment, the mixing tank walls are
manufactured from materials including at least one of ethylene
vinyl acetate and metallocene polyethylene. In another embodiment,
the walls 110, 120, 130, 150 comprise a stretchable material,
having a deformation of less than approximately five percent when
subjected to a tensile force of 100 gmf per inch (per 2.54 cm) of
width. The tank and sleeve walls 110, 120, 130, 150 define the
storage and/or mixing compartment that isolates components therein
from the outside medium/environment. The films 110, 120, 130, 150
preferably also have a mechanical resistance such that the
disposable mixing tank 100 may be used under pressure from the
outside medium/environment. Preferably, the walls of the disposable
mixing tank and sleeve are manufactured from similar materials,
having similar thicknesses. In a preferred embodiment the wall
thickness of each of the walls of the mixing tank and sleeve is
about 200 microns.
[0065] In a further embodiment, the mixing tank walls 110, 120, 130
are substantially clear to allow for the viewing of the components
and the mixture thereof, such that one skilled in the art may
determine when the mix operation is complete based on viewing of
the components. In one embodiment, the mixing tank walls include
volumetric indicia for measuring the volume of the components
therein.
[0066] In another embodiment, the disposable mixing tank 100 is a
single-use apparatus. In particular, the mixing tank 100 is used to
mix, at least partially, components contained therein. More
preferably, the mixing tank is used to at least partially mix and
store components therein. The result of the mixing of the
components may be removed from the mixing tank 100 (as described in
more detail below). Thereafter, the mixing tank 100 is discarded.
Accordingly, there is no need to wash/sterilize the mixing tank 100
in preparation for subsequent uses. Moreover, because the mixing
tank 100 is a single-use apparatus, the mixing tank 100 does not
have the ongoing maintenance costs associated with conventional
mixing devices.
[0067] The at least one outlet opening, 170, allows for draining
the contents of the disposable mixing tank 100. While the mixing
tank 100 is illustrated with separate inlet(s) 160 and outlet(s)
170, embodiments of the invention are not so limited. For example,
in an embodiment, a single opening could be used for both loading
and draining of components and/or mixtures.
[0068] In one embodiment, the inlet opening(s) 160, and the outlet
opening(s) 170 include a base plate welded onto the internal or
external face of the mixing tank walls 120, 130, such that one end
of the opening emerges inside the wall 120, 130 and the other end
emerges outside the wall 120, 130. Furthermore, the inlet openings
160 and the outlet openings 170 may be closed using a number of
devices, such as tight plugs. In one embodiment, the diameters of
the inlet openings 160 and the outlet openings 170 is dependent on
the flow rate that a particular component is to be introduced into
the mixing tank 100, and/or the admix operation that is to occur by
movement of the mixing device arranged in the sealed sleeve 140.
For a gas component, the gas inlet and outlet rate (or pressure)
may be such that there is a sufficient homogenization of the
components in the disposable mixing tank 100.
[0069] In a further embodiment, inlet opening(s) 160 and outlet
opening(s) 170 may be used to introduce different types of probes
into the mixing tank 100. For example, pH, pO2, temperature or
pressure probes can be introduced into the mixing tank 100 through
a number of inlet 160 and/or outlet 170 openings to check the
status of the components and/or the result of the mixing of such
components within the mixing tank 100.
[0070] The components to be stored in and the components that are
to be admixed (mixed), at least partially together, during motion
of the mixing device inside the flexible sleeve 140, may be in
different phases (different types of solids, liquids and/or gases).
For example, the solid components may be different types of
powders. The liquid components may be in different organic phases
and/or aqueous phases. The gases may include oxygen, air, nitrogen,
argon, carbon dioxide, etc. In one embodiment, the components are
substantially homogenized. Moreover, the different components may
or may not be soluble in reference to each other.
[0071] Any of a number of combinations of different components in
different phases can be admixed in accordance with embodiments of
the invention. For example, a first component in a solid phase may
be mixed with a second component in a solid phase. A first
component in a solid phase may be mixed with a second component in
a liquid phase. In one such embodiment, a powder is suspended in a
liquid component when the powder may be partially or totally
insoluble in the liquid component. In an embodiment wherein the
powder is totally soluble, the operation of the mixing tank 100 is
such that the result is a homogenized solution of the powder and
the liquid.
[0072] Further, a first component in a liquid phase may be mixed
with a second component in a liquid phase. In one embodiment, the
first liquid component may be partially soluble, totally soluble or
totally insoluble with reference to the second liquid component. If
at least one liquid component is at least partially insoluble in at
least another liquid component, an emulsion is obtained after the
mixing/stirring of the mixing tank 100. In an embodiment, if the
liquid components are soluble in reference to each other, the
operation of the mixing tank 100 is such that the result is a
homogenized solution of the two different liquid components.
[0073] A first component in a liquid phase may be mixed with a
second component in a gas phase. The gas may be inert or may react
with at least one component of the liquid component. For example, a
gas (that is relatively reactive under the desired conditions) may
be oxygen or carbon dioxide when culturing cells or microorganisms
or to provide for an oxidation reaction.
[0074] The width/diameter of sealed sleeve 140, and the
width/diameter of the inlet(s) 160 and outlet(s) 170, are dependent
on the size of the mixing tank 100 and on the identity of the
components to be mixed and/or transferred. The width/diameter and
height of sealed sleeve 140 must allow for the arrangement of
mixing means therein. Moreover, the dimensions of the sealed sleeve
140 are based on the size of the mixing tank 100 and the physical
characteristics of the components to be mixed. Examples of the type
of characteristics on which the diameter of the sleeve 140 is
dependent include viscosity, granulometry, density, thixotropy and
rheoscopy.
[0075] In one embodiment, the mixing tank 100 also includes at
least one valve to allow for a release mechanism in the event that
pressure builds up within the mixing tank 100 because of the
mixing/rotation operation.
[0076] In a further embodiment, the disposable mixing tank 100 may
comprise a support frame 115, as shown in FIG. 1. The support frame
may surround the disposable mixing tank 100 and can couple to the
mixing bag 100, through one of a number of connection apparatus
(e.g., a clip, a hook, etc., not shown). The frame may additionally
function as support for mixing means and related ancillaries.
Accordingly, the support frame supports the mixing tank 100, so as
to maintain a sufficient tension during loading of components into
the mixing tank as well as during the mixing of the components
contained therein.
[0077] FIG. 7 illustrates disposable mixing tank 100, comprising
mixing means 700, whereby both mixing tank 100 and mixing means 700
are supported by a frame 115. Motor-wheel driver 710 couples to
rotation wheel 720, which couples to mixing stick 730 through
bearings 740, 750. The motor-wheel driver 710 may communicate
directly with a processor to execute machine-readable instructions
for controlling the rotation of the mixing stick 730, including the
number of turns, the rate of rotation, the angle of rotation, and
how far to turn for a given rotation, as described in more detail
below in conjunction with the description of the flow diagram 800
of FIG. 8.
[0078] In a further embodiment, the disposable mixing tank of the
present invention may further comprise a secondary containment
system for containment of materials, which may leak from the tank
during storage, processing, and/or transfer of such materials into
and/or out of the mixing tank. The secondary containment system may
be fixed or portable. Further, the appropriate secondary
containment system for use with the disposable mixing tank may be
readily determined by one skilled in the art.
[0079] In a further embodiment, the disposable mixing tank of the
present invention may further comprise external heating and/or
cooling means for controlling the temperature of components in the
disposable mixing tank. The secondary containment system may serve
as housing for a fluid that conducts heat into or out of the
disposable mixing tank, such as with heating and cooling baths.
Alternatively, the heating and/or cooling means may envelope the
exterior of the disposable mixing tank or a portion thereof as in,
for example, heating jackets, heating and cooling tanks, heat
exchangers, chillers, and fluid cooling systems. As a still further
alternative, the mixing tank may comprise a liner, exterior to the
outer walls of sealed cavity 140 and mixing tank 100. The liner
preferably envelops at least a portion of the mixing tank and
provides a sealed gap or space between the liner and exterior walls
of sealed cavity 140 and mixing tank 100. The gap or space is
useful for containing fluids having heat and/or cooling capacities.
Preferably, the heating and/or cooling fluid contained therein is
circulatable in the gap or space by circulation means.
[0080] FIG. 8 illustrates a flow diagram for the steps of a method
for mixing components, according to a further embodiment of the
invention. In a first step described in block 802, components are
loaded into mixing tank 100 through an inlet 160. The inlet 160, or
multiple inlets (not shown), may be opened in an order that is in
accord with a mixing protocol for the components to be loaded into
mixing tank 100. For example, a more homogenous solution may be
derived for three components if a first component and a second
component are mixed, followed by the mixing of the third component
into the mixture of the first component and the second
component.
[0081] In the first step described in block 802, the components may
be loaded simultaneously or based on a mixing protocol or
instructions from a CPU. As described above, the number of inlet
openings 160 allow for the introduction of components ("raw
materials" or "reactants") to be mixed within the mixing tank 100.
Control continues at a second step described in block 804.
[0082] The loading operation as described in the first block 802,
while described such that the operations of the second block 804
are subsequent to the operations of the block 802, is not so
limited in all embodiments. For example, as described above,
different inlets may be opened at different times during the mixing
of the components in order to follow a mix protocol for a given set
of components. Accordingly, the opening of an inlet for filling may
follow a first mix operation, which is followed by a second mix
operation.
[0083] In a second step described in a second block 804, the
components loaded into the mixing tank 100 are mixed, at least
partially, based on rotation or other motion of the mixing device
as shown in FIG. 7. The mixing of the components may be performed
or controlled by an individual and/or a control apparatus (not
shown). The mixing of the components may be carried out by a number
of rotations of the mixing means 700, wherein one rotation includes
rotating at least a 360 degree turn. In one embodiment, the range
of motion through the 360 degree rotation is in a plane parallel to
the mixing tank base 110.
[0084] In an embodiment to generate a homogenous solution, the
rotation of mixing means 700 in the mixing tank 100 continues until
the components are approximately homogenized. In an embodiment that
includes mixing a liquid and a powder that is at least partially
insoluble, the rotation of mixing means 700 continues until the
powder is suspended in the liquid.
[0085] Moreover, as described above, a number of open passage
operations and mix operations may occur in order to follow a given
mix protocol. Accordingly, a number of mix operations may occur
until the different components are mixed, at least partially, into
the final resulting component. Control continues with a third step
described in a third block 806.
[0086] In a third step described in the third block 806, the at
least partially mixed components are drained from the mixing tank
100. In one embodiment, the mixing tank 100 is positioned such that
when a plug type device is removed or a valve is opened, mixed
components drain from an outlet 170. The drain operation may be
facilitated as desired. For example, when the component is a
viscous solution having a slow flow, the drain operation may be
facilitated through a number of operations. In one embodiment, the
drain operation is facilitated by an increase in pressure initiated
by introducing a gas into an inlet opening(s) 160. Control
continues with a fourth step described in a fourth block 808.
[0087] In the fourth step described in the fourth block 808, the
mixing tank 100 is discarded. In particular, the mixing tank 100 is
discarded after a single use. Accordingly, the washing/sterilizing
operations as well as the maintenance associated with conventional
mixing devices are not needed. Moreover, as described, embodiments
of the invention reduce the amount of human contact with the
components (which may be hazardous, dangerous and/or infectious)
that are to be mixed as part of and during the mixing of such
components.
[0088] Thus, a method, apparatus and system for different
embodiments for mixing solids, liquids and/or gases have been
described.
[0089] While the invention has been has been described herein in
reference to specific aspects, features and illustrative
embodiments of the invention, it will be appreciated that the
utility of the invention is not thus limited, but rather extends to
and encompasses numerous other variations, modifications and
alternative embodiments, as will suggest themselves to those of
ordinary skill in the field of the present invention, based on the
disclosure herein. Correspondingly, the invention as hereinafter
claimed is intended to be broadly construed and interpreted, as
including all such variations, modifications and alternative
embodiments, within its spirit and scope.
* * * * *