Isolated pressurization system and bag configuration

Abstract

System components and configuration includes a pressure-rated vessel (20), and a primary bag (7), containing a flowable substance to be dispensed. The vessel (20) having an opening, includes a bag within bag assembly configured as an isolated pressurization system that surrounds the primary bag (7). The pressurization assembly is composed of at least a first sheet flexible film material configured as an enclosable first bag (11), and at least another first sheet configured as an enclosable second bag (12). A portion of (11), is joined to a portion of (12), at an annular seam (25), that includes one or more lumen tube (15) lengths, and may include conductive wires (30), sandwiched between portions of seam (25). Additional system components include bracer element (18), retaining cover (21), crown cap (22), space frame component (14), provisions for sensors (32), heating cooling elements (31), permeation sensors (43), and vibration devices (44). An external pressure source (not shown) supplies a gas or liquid through the lumen tubes(s) (15), to areas between combinations of bag layers that compresses the primary bag (7).

Description

BACKGROUND

Commercial, food, industrial, medical, pharmaceutical and beverage industries recognize the benefits of flexible film bags. Storing/dispensing fluids from flexible film bags is an accepted practice in many scientific fields.

Examples include mammalian cell cultures, viscous fluids, edible compositions, toxic or infectious substances, and reactive substances. These liquids, flowable substances, can be manipulated directly from flexible film bags.

Bag technology is rapidly developing specialized films to safely package flowable solutions such as solvents and acids.

Dispensing a flowable substance enclosed first in a flexible film bag that is surrounded or otherwise supported by a frame or a rigid container of some kind, has advantages over just dispensing or transferring a flowable substance directly from the container. Using flexible film bags for dispensing flowable substances greatly reduces the time needed to clean, rinse, and sterilize the containment vessel. Unused portions can be quickly contained and or sealed and removed for later use.

The evaporation or spoilage concerns are considerably lower for substances first in a bag rather than resealing an opened container.

A flexible film bag after depletion, can leave a support vessel relatively residue free. Another advantage is the dispensing volume of a flexible film bag is subsequently reduced as substance is removed from the bag. Regardless of how much fluid is dispensed or added to the bag during a typical application cycle, the variable volume inside the bag does not allow ambient atmosphere to enter or exit. A depleted bag will have almost zero volume at the end of this cycle. Depleted bags can be refilled or discarded, and can be recyclable items. Removing a bag after depletion provides a reusable outer container that can be quickly returned to service. It is efficient for workers to safely manage any residue at the fitment portion of the bag. Fitments are typically tubes/conduits sealed to these bags, and are less complicated to service. On-off valves “down stream” from the containment vessel, in emergencies can greatly reduce maintenance confusion. When manipulating sensitive or toxic substances, an enclosed depleted bag can be quickly separated, closed and/or replaced with another bag without the need to clean or service the line or the containment vessel.

From a manufacturing standpoint, flexible film bags can have relatively thin wall construction. “Burst strength” of seam welds can be reducible as well. A thin flexible film bag positioned within a rigid support container becomes stronger than just the film itself. Utilizing a support container would typically, be constructed to be able to contain the flowable substance and be rated for strength anyway without a bag liner.

The implementation of thinner flexible film materials for bag walls unfortunately will have some setback consequences, when applying conventional pumping methods. One such problem is twisting and/or collapse of the bag walls limiting complete dispense of the fluid. However, cost saving incentives will drive manufacturers toward, the use of thinner walled dispensing bags in general. This may require alternative dispensing methods. Flexible film bag use will continue demonstrating their advantages. Bags are desirable for having reduced disposal volume, reduced shipping/handling weight, and less storage space needed for folded/flattened bags. Another feature, sterilizing, is less problematic. Typically, the process to sterilize a bag is concentrated through a small fitment passageway and is easy to seal the inner portion of the bag. Reusable support vessels may not require sterilizing and can be rearranged, stacked, and stored more efficiently.

Dispensing From a Bag

Examples of a flexible film bag application as utilized in the shipping/transportation fields, are the intermediate bulk containers (IBC's) frequently used to ship, store, transfer, and otherwise manipulate liquids and/or viscous substance materials. IBC's typically hold more than a 55-gallon drum but less than a bulk drum (500 gallon). IBC's are generally of the “bag in box” design including an inlet/outlet port construction where a primary container in the form of a flexible collapsible inner bag contains the material and a rigid box or frame-like structure forms a secondary container to house the flexible bag. When transporting palletized containers of this type, the large volume containers are loaded many times from a truck or another large freight-type compartment, such as a freight ship, to conveyors and are picked up and set down by forklifts. The outer walls of the enclosed bag after inspection have been subjected to continuous and abrasive movement of the bag against the walls of the rigid container. Such abrasion can result in bag damage, leakage, and resultant loss of contents and contamination of surrounding areas.

Advancements in flexible film technology have anticipated and addressed in part IBC fluid storage and handling, with the advent of multiwall barrier films, improved lamination techniques, advanced seam construction, lubrication of bag surfaces, etc. This has contributed to the increased application possibilities of flexible film bags within the bulk fluid industries

The beverage and food industry also recognizes the benefits of flexible film packaging. Flexible film bags are generally, integrated in a “closed system,” that anticipates dispensing of a flowable substance in a reasonably sanitary manner. Cleaning processes are typically reduced by replacing a collapsed bag with a filled bag without the need to clean/sterilize/refill the line or containment vessels. Some “down-stream” problems still afflict the system though. A mechanism is required to pump or expel the beverage, a nozzle or interface is used between the beverage and the external environment, and a device to control the flow rate of the beverage is typically employed. Periodically these systems need to be flushed and cleaned; requiring parts disassembly of the pumping mechanism.

Flexible film bag use in the medical/pharmaceutical industries is another example. Processes routinely manipulate liquids using flexible film bags and often require an “agitation free” flow system when transferring mammalian, microbial cell cultures, biological materials, liquid medications, and/or infectious agents. Gravity flow systems can limit the agitation of delicate fluids however. Reverse suction at the end of a dispense cycle is a reoccurring problem, often requiring additional monitoring. Within these systems environmental containment, worker safety, and flow line control are paramount. Generally, these systems rely on precision transfer devices routinely requiring maintenance and inspection. Disposal and/or transferring these substances depend on sterile, aseptic conditions throughout all stages.

Current Methods

To expel or dispense a liquid from a bag generally depends on conventional mechanical devices such as the diaphragm pump, a peristaltic pump, a direct gas pump, or by using gravity to cause the substance to flow out of the storage container.

A diaphragm pump uses a movable diaphragm to directly push the liquid out of the storage container. A disadvantage of this type of prior art pump is that the liquid, being pumped comes in direct contact with internal parts of the diaphragm pump. Such contact increases the risk of bacterial contamination and makes the system difficult to clean and sanitize.

A peristaltic pump, on the other hand, comprises a rotating apparatus which periodically squeezes a substance through a flexible tube. One disadvantage with using a peristaltic pump is when changing to a different liquid the pump and tubes need to be evacuated and sterilized before the next operation. Another disadvantage of the peristaltic pump is the rotating drive can wear to the point of allowing environmental air or other particle contaminations to enter into or escape the system.

A direct gas pump dispenses a flowable substance with compressed gas, typically used for carbonated beverages such as beer in a keg. In this system, a compressed gas is introduced into the liquid container, the pressure of which expels the liquid. A major drawback with this method however, when applied to edible, organic, or sensitive fluids such as cell cultures, is that direct contact with these fluids can contaminate or cause spoilage and/or environmental contamination.

In a gravity flow system, the weight of the liquid provides the force to expel the substance. One disadvantage of the gravity flow system, however, is that the flow rate of the dispensed liquid is dependent on the head pressure (egress/ingress port) of the fluid inside the container. As the liquid empties, the head pressure decreases, which results in a reduction of flow rate. A second disadvantage of the gravity flow system is that substances that are more viscous will flow at unacceptably slow flow rates.

Utilizing pumps and/or direct gas infusion, or gravity to dispense liquids from flexible film bags is generally problematic. Flow control is uneven in most cases and limited by the above disadvantages associated with these systems.

An alternative dispensing system is needed that can better manage dispensing a flowable substance from a flexible film bag: an isolated pressurization system that does not pump the substance or alter the composition of the substance at any stage of the flow cycle. Isolated pressure to dispense a flowable substance from a bag should not be subjected to alternating suction or infusion of gases as with conventional prior art pumping or gravity systems. The risk of leakage or spillage of the primary fluid is considerably, lowered by eliminating the use of conventional in-line pump mechanisms.

Alternative Requirements

As an alternative system capable of manipulating flowable substances enclosed in flexible film bags without relying on inline pump mechanisms or gravity, an alternative solution should:

• • Be operable as an “agitation free” flow system capable of delivering a pure flow rate, ideally, eliminating maintenance/service time of inline rotating mechanisms.
  • Be operable as a “closed loop” configuration, providing an uninterrupted transfer of fluids, and reducing the risk of exposure to the surrounding environment.
  • Provide a low cost reusable system assembly, that is adaptable to existing flow cycle operations, and compatible with the sterilization standards developed within scientific, commercial, and medical fields.
  • Provide a system that does not squeeze or otherwise alter sensitive substances such as mammalian cell cultures at critical cycles of operation, while reducing the risk of direct contact with these fluids.
  • Provide a system that can better manage delivery/dispense control of flowable substances, without the complications of reverse suction, agitation, or contamination associated with mechanical pumping systems.

System Benefits

• • System components may be low tolerance non-binding parts assemblies, thus reducing the dependence on precision-machined tolerance requirements and eliminating the need for sealants, gaskets, technical tools, etc.
  • The dispenser configured for thin walled flexible film bags provides an additional liner interface between the dispense bag and the pressurization chamber.
  • Components and bags configure through a single opening, also components and bag configurations are interchangeable with a common vessel.
  • Sensors such as temperature, pressure, volume can be configured in close proximity to a dispense bag throughout a dispense cycle providing more accurate data readings.
  • Provisions for heating and cooling means substantially surrounding a dispense bag increases efficiency.

BRIEF DESCRIPTION

An isolated pressurization system can dispense a flow able substance from a flexible film bag, without the use of conventional in-line pumping devices, or gravity-flow manipulation. The system is similar to squeezing a tube of toothpaste as a comparison. Specifically, an isolated pressurization system that substantially surrounds the flexible film bag containing a flowable substance, and can gently or forcefully expel the contents. The system assembly to dispense a fluid from a flexible film or “primary bag” (7) consists of an enclosable first bag (11) configured inside a second enclosable bag (12). A surface wall portion of each bag is joined at an annular seam (25) location. A bag-in-bag assembly patented in U.S. Pat. No. 7,896,199 KACZMAREK held by applicant, is improved on, by adding a lumen tube (15) sandwiched between surface portions of the first and second bag walls at the seam location. The lumen tube (15) traverses a segment of the annular seam (25), and welds with the walls in a liquid-proof manner. The material within the annular seam (25) may be a weakened area (13) that is sliced, perforated, or otherwise removed. The system bags may be enclosed at least two possible ways. The inner bag (11) edge portions are seamed, together in a liquid-proof manner to substantiality enclose the first bag (11), and the outer bag (12) edge portions subsequently are seamed together in the same manner enclosing the second bag (12). A second way is when the annular seam (25) is opened prior to enclosing the bags, they may be adjacent each other and edge seamed separately. Appling this method of assembly, one of the bags folds into the other through the annular seam (25).

After assembly, the system portion is positioned in a pressure-rated vessel (20) having an opening. The annular seam (25) is subsequently secured at the mouth of the vessel. A primary bag (7) passes through the annular seam (25) and is positioned within the vessel (20) ready for filling and dispensing. The primary bag (7) enters the inner-most bag (11). The bag (11) having at least a first liner, isolates the primary bag (7) from the pressurizing means. A bracer element (18), positioned in the opening of the vessel, reduces the area of the vessel (20) opening to approximate the diameter of a primary bag conduit (9). The lumen tube (15) exiting the vessel (20) connects with a pressurizing means (not shown). The pressurizing means is introduced through the lumen tube (15) to increase the volume between the first and second bag(s) (11), (12). A retaining means (21) and cap (22) secures the bracer element (18) atop a primary bag (7) and interlocks with the vessel (20). Additional embodiments and components of the present invention can be further appreciated from the detailed description given herein and the accompanying drawings which are given by way of illustration only and thus are not limitative of the present invention.

FIGURE DESCRIPTION

FIG. 1 Isolated pressurization system and bag configuration

FIG. 2 Illustrative view of bracer element as frame structure on a primary bag having sensor leads exiting

FIG. 3A Illustrative view lumen tube passing through sleeve and bottom flange positioning annular.

FIG. 3B Illustrative view of variable diameter retaining sleeve

FIG. 4 View of enclosed annular seam with lumen tube portion coiled between film layers

FIG. 5 Spool type bracer element

FIG. 6 Bracer element, lumen tube coiled around center

FIG. 7 Expanded diagram of crown cap, retainer ring, 2 piece bracer element and 2 egress/ingress conduits fitment flange

FIG. 8 3D view including a side view drawing with callout, first and second sheet aperture area lumen tube and cable between sheet surfaces

FIG. 9 2D Illustration view of annular seam extension and weakened film enclosing system components

FIG. 10 Stretch out view of multiple piece bracer components, primary bags, and retainer ring

FIG. 11 Close up illustration of seam weld and lumen tubes passing between film layers

FIG. 12 Drawing of bag in bag with lumen tubes, film layers configured as enclosable/enclosed bags

FIG. 14 Top view of possible vessel shapes with “slot like” opening a bracer disc element positioned inside

FIG. 15 Bracer element disc with raised portion and support element

DEFINITION OF SEAM AS USED HEREIN

Refers to a seam/seal area of a first region of one or more inside and/or outside flexible film surface(s) to a second region of one or more inside and/or outside flexible film surface(s) region wherein the seam/seal is a liquid proof, impervious to gas, weld or bonded area connecting the films, formed by gluing, compression fitting, and/or heating the regions to at least their respective seal initiation temperatures. Heating/welding can be performed by any suitable means such as using a heated bar, hot air, direct flame, infrared radiation, radio frequency radiation, ultrasonic sealing, or the like.

Definition of Annular Seam as Used Herein

A welded or not welded surrounding ring like configuration includes straight and/or curved inside perimeter area, a welded seam surrounds portions of un-bonded film surfaces that enclose volume between surfaces, and the surfaces are either weakened, sliced, punctured, perforated, or otherwise removed before or after bonding and before use whereas, the surrounding outer perimeter may be larger than the inside perimeter, and the seam may include outer perimeter extension segments about the seam.

DETAILED DESCRIPTION

FIG. 1 an isolated pressurizing system components and bag configuration, can dispense a flow able substance contained in a flexible film bag consists of:

A first flexible film sheet composed of at least one or more sheets and may include one or more layers or liners configured as an enclosable first primary bag 7. Primary bag 7 configured to contain a volume of flowable substance to be dispensed. A primary bag 7 may include metallic layers and/or conductive elements between and/or part of liner surfaces. The layers/liners may derive, from a group of thermoplastics or polymers that remain flexible after the polymerization reaction when forming the layers. A primary bag 7 has at least a first egress/ingress means such as conduit 9 configured as a passageway to at least a first inner most area and volume. A primary bag 7 may include a first flange 8 that connects in a liquid proof manner to the bag and a first conduit 9. Conduit 9 and flange 8 may derive, from a group of thermoplastics or polymers that remain flexible after the polymerization reaction when forming these components. Flange 8 and conduit 9 may include metallic elements. At least one or more combinations of layer edge seams of bag 7 subsequently are seam/sealed together in a liquid proof manner enclosing at least a portion of first primary bag 7.

It is contemplated where a corrosive flow-able substance is to be contained and dispensed, a primary bag 7 may have one or more inner flexible metal liner/layer surfaces, configured as an enclose able primary bag 7. Conduit 9, and flange 8 may be a one or more component assembly, and may include interlocking threads, or welded or compression fitting these components together. Flange 8 and conduit 9, compose a fitment assembly and may include a flow controllable device or other flow controllable means approximate flange 8 and in-line with conduit 9. A gas escape hose 10 when present may include a one-way valve, removable plug or “pinch off” type or other comparable closing or otherwise flow controlling means. Flange 8, may include raised surface portions and may include a gas escape hose 10. hose 10 may be configured, as an access conduit for probes, wires, or otherwise sensor elements to the volume of a primary bag 7. Hose 10 may be transparent and serve as a fill indicator.

The isolated pressurization system cross sectional view FIG. 1 is in part a bag within bag within bag configuration assembly. A first flexible film sheet, layer or liner 11 composed of one or more sheets and one or more liners and may derive from a group of thermoplastics and/or polymers that remain flexible after the polymerization reaction when forming the liners. Liner(s) 11 may be impervious to gas/liquid infusion have outside and inside surface area and may include metallic layers and/or conductive elements between and/or part of layer surfaces. At least a first liner 11 portion edge regions are seam/sealed together to form an enclosable first bag 11, capable of containing a flowable substance. Bag 11 may include additional liners that may or may not have all edge portions seamed. Portions of lumen tubes, wires cables, may be affixed to portions of surfaces and/or edge seams. Embodiments may include lumen tubes, wires, cables transverse a segment of edge seams and enter between enclosed surfaces of combinations of liner(s) 11 and/or liner(s) 12.

A first liner/layer 11 as an enclosed first bag configured to substantially surround a primary bag 7. Layers or liners 11 configured as an enclosable first bag, should have sufficient internal surface area at least equal to or greater than the outer surface area of a primary bag 7 filled to maximum volume. Increased internal bag 11 area may be required for internal seam allotments additional conduits 9 and flange 8 clearance plus any lumen tube segments 15A, reclosable tubes 27, space frame components 14, cables containing wires 28 (FIG. 2), heating and/or cooling elements 31, permeation sensors 43, vibration devices 44 etc. positioned therein or between combinations of layer(s) 11. In some embodiments more than one flange 8 may be present and include divider(s) 47 or separation means, and may have raised structural elements between surfaces of layer(s) 11, and the outside surface of primary bag 7. In some embodiments sensor elements 32, and or conductive wires 30, may be inserted through a reseal able tube 27, in which case the internal area of bag 11 should be increased proportionally. Liner(s) 11 isolates compression gases/liquids, reaction substances or other pressurizing means from contact with the primary bag 7 outer most surface. The liner(s) 11 may include stretchable layers. In some embodiments portions of liner(s) 11 separate components between layers and/or from the primary bag 7. Liner(s) 11 may include compression fabric, insulation and/or other spacing components, as well as tubes, cables, wires, and may include reactive substances between layers. In some embodiments, sensor elements 32, conductive wires 30, heating or cooling elements 31, and/or vibration devices 44, may be affixed to and/or between layers of primary bag 7 and/or liner(s) 11.

FIG. 1 At least a first one or more flexible film sheets including at least one or more liners where the edge regions of at least one first liner sheet is subsequently seam/sealed together at approximate the liner(s) edge portions form an enclosable second bag 12. The enclosable portion(s) of layer 12 may have lumen tubes wires, cables, connected at and/or passing through seam segments. Embodiments include lumen tubes, wires, cables may transverse a segment of edge seams and enter between enclosed surfaces of combinations of liner(s) 11 and/or liner(s) 12. Bag 12 may have one or more sheets that enclose a volume and area capable of containing a gas/liquid, reactive substances, or other pressurizing means. Bag 12 may have more than one layer or liners impervious to gases/liquid infusion. Bag 12 may have metallic layers and/or metallic elements between and/or part of layer surfaces and derive from a group of thermoplastics and/or polymers that remain flexible after the polymerization reaction when forming the layers. Layer(s) 12 have outside and inside surfaces and may have one or more seams approximate edge portions configured to enclose a first volume. At least a first liner 12 configured as an enclosed second bag should have an inside area sufficient to contain the combined area of a maximum volume primary bag(s) 7 that may include system components and including liner(s) 11 configurations, including sufficient area for seam segments and including any combinations of components positioned therein.

A preferred embodiment consists of Liner(s) 12 portions configured as a first enclosable second bag that surrounds Liner(s) 11 configured as a first enclosable first bag. Either bags may include system components wires, lumen tubes, fitments, bags, configured therein. At least a first surface portion of a first liner 11 joins to at least a first surface portion of a second liner 12 and including a first lumen tube sandwiched between a first surface portion of bag 11 and a first surface portion of bag 12. An annular seam 25 bonds a surface portion of bag 11 to a segment of lumen tube portion and to a surface portion of bag 12 in a liquid-proof manner. The lumen tube transverse a segment region of the annular seam 25 such that an end portion of lumen tube 15 protrudes from an inside perimeter segment of the annular seam 25. The opposite end portion of lumen tube 15A protrudes from an outside perimeter segment of annular seam 25. It is understood, that the material within the annular seam 25 may remain unbroken prior to system configuration, and/or some layer surface portions may be cut, separated, or otherwise removed, prior to system operation. Edge portions of a first enclosable first bag 11 are seamed as an enclosable/enclosed first bag 11. Edge portions of a first enclosable second bag 12 are seamed as a first enclosed/enclosable second bag 12.

Another embodiment bag configuration assembly is possible and consists of liner(s) 11 portions configured as a first enclosable bag. Liner(s) 12 portions configured as a first enclosable second bag. The bags are adjacent each other prior to joining. Either bags may include system components wires, cables, lumen tubes, fitments, bags, configured therein. At least a first surface portion of a first liner 11 joins to at least a first surface portion of a second liner 12 and including a first lumen tube sandwiched between a first surface portion of bag 11 and a first surface portion of bag 12. An annular seam 25 bonds a surface portion of bag 11 to a segment of lumen tube portion and to a surface portion of bag 12 in a liquid-proof manner. The lumen tube wires, cables, transverse a segment region of the annular seam 25, such that an end portion of lumen tube 15 and wires, cables, protrudes from an inside perimeter segment of the annular seam 25. The opposite end portion of lumen tube 15A and any wires, cables protrudes from an outside perimeter segment of annular seam 25. The film material within the inside perimeter of seam 25 may be a weakened area that is cut, sliced, or otherwise removed before the bags are enclosed. Edge portions of a first enclosable first bag 11 are seamed to substancely enclose first bag 11. Edge portions of a first enclosable second bag 12 are seamed to substantially enclose a second bag 12. Subsequently one of the bags may be rolled into the other through the annular seam 25 providing a bag-in-bag assembly.

Seam 25 may not bond all liners of either liners 11 and/or liners 12 with this first seam. A (second) seam 25 may be configured around the outside perimeter edge of a first seam 25 and may bond combinations of liners 11 and/or liners 12 not bonded by a first seam. The seam(s) 25 may include one or more lumen tubes 15 end portions within the inside perimeter area of annular seam 25 and one or more lumen tubes 15A end portions protrude from the outside perimeter portions of an annular seam 25. The lumen(s) are sandwiched and welded between combinations of layers 11 and combinations of layers 12. The lumen tubes traverse an inside perimeter portion and an outside perimeter portion of a segment of seam 25. Where more than two sheets are bonded by an annular seam 25 one or more lumen tubes, wires, cables may pass unbroken through a segment of inside perimeter aperture to an opposing segment inside perimeter of same or second aperture to exit/enter between different layer sheet surfaces. Lumen tubes, surface portions of wires, cables should be of materials bondable with the seams and flexible film sheets in a liquid proof manner and may be pressure rated and derive from a group of thermoplastics and/or polymers that remain flexible after the polymerization reaction when forming.

When more than one layer is configured as an enclosed/enclosable layer 11, openings or weep holes may be present in selected regions of layers that configure layer 11. Gases liquids, reactive substances entering a first layer 11 may partly surround and enter that layer before entering a second layer and could continue to additional layers.

Seam 25 may bond, wires, cables, metallic elements seamed in the same manner as lumen tube(s) 15. In some assemblies weld filler may be utilized (FIG. 8 call-out), in part or all of seam 25. The inside perimeter of the annular seam 25 region is sized to allow one or more primary bag(s) 7 and any associated components to enter or exit damage free to an inner most surrounding portion of liner(s) 11.

Lumen tube portion 15A, may have a space frame component 14 configured at an end portion and positioned approximate between surface portions of Liner(s) 11 and surface portions of Liner(s) 12.

Space frame component 14 having holes about the frame may be a stand alone component or otherwise may be affixed to a lumen tube end portion and may include a ‘ball in basket” or equivalent type one way flow component or may have flexible film configured as a “collapsible” lumen segment. The segment functions as a one way valve. The space frame component 14 provides space for gasses or reactive substances to expand. In some embodiments, component 14 may be an enclosed pouch 51 including more than one layers, attached to a lumen tube portion 15A.

Other embodiments include a pouch 51 may have weakened areas, semi.-flexible structure within the pouch allowing gases, liquids, reactive substances to expand in a controllable manner. Pouch 51 may be positioned between combinations of surface liner(s) 11 and/or surface liner(s) 12. The isolated pressurization system with or without primary bag(s) 7 inside, is positioned and secured within a pressure-rated containment vessel 20. Insertion of the bags by folding, rolling or crunching and/or added lubricant, is possible and should provide a damage free removable instillation.

Vessel 20 having an opening, a neck portion commutating with a volume and internal area. The neck portion may have internal or external threads interlocking with matching internal or external threads of an open top retaining cover means 21. It is contemplated other attaching/locking means are possible, including but not limited to internal or external aliment regions, pins, tabs, tape, springs, clips, grooves, screws slots or the like. The open top retaining cover means 21 connects at a neck portion and prevents the bracer element 18 and positioning sleeve 16 from being forced out of the vessel 20.

Positioning sleeve 16 fits inside the neck portion of vessel 20, and positions and secures seam 25 approximate the internal open portion of vessel 20. Sleeve 16 may consist of one or more part components and may be semi rigid, flexible, and/or split or segmented along a length to allow a lower positioning sleeve flange 19 to pass through the neck of vessel 20. Sleeve 16 may be of flexible material and flange 19 may be seamed, glued, welded to seam 25. Openings 24 (FIG. 3B) may be provided and located approximate a wall of sleeve 16 and lower flange 19 allows lumen tubes 15 reseal able tube 27, cables containing wires 28, conductive wires 30, or combinations thereof to exit the opening of the neck. Upper positioning flange 17 may fit over a top edge portion of vessel neck. In some cases sleeve 16 may have flange 19 removably attached at a portion of seam 25. In other embodiments a portion of sleeve 16 is secured to the inside neck by means of tape, glue, or other removable or non-removable fastening means. A primary bag(s) 7 may be inserted or removed through sleeve 16 or pre-packaged inside bag 11.

Referring to FIG. 1, and FIG. 2 bracer element 18 positions primary bag egress/ingress conduit 9 approximate inside center of neck bore, and may be part of, or removable with sleeve 16.

The bracer element 18 when positioned in the neck acts as a securing plug or brace between a retaining cover means 21 and primary bag fitment flange 8. Bracer element 18 may be cylindrical, cubical, spherical, triangular, or other shape configuration, and may be constructed of wood, metal, plastic or other non-crushable material. Bracer element 18 prevents a flange 8 and/or conduit 9 from being forced out of the neck of vessel 20 when a pressuring force is applied between surfaces of bags/liners 11 and surfaces of bags/liners 12.

FIG. 2 illustrative view of bracer element as a frame structure having space for wires, cables, external probes, and access to primary bag 7 and flange 8 and conduit 9. Other embodiments a portion of flange 8 of primary bag 7 may have a conductive area 35 accessible through bracer element.

FIG. 1 illustrates an aseptic closure assembly including an open top retaining cover means 21 that threads to neck of vessel 20 and a removable crown cap 22 that may be separate able, rotatable, twist in, snap in, or other releasable means and may include gaskets, o-rings, sealant, and/or utilize compression or form type fittings 23, or other suitable means effectively limiting infusion of dust, gases, liquids or other external contamination.

Open top retaining cover means 21 secures flange 17 to the top edge portion of the neck of vessel 20. Open top retaining cover means 21 also secures bracer element 18 to an outer surface portion of primary bag(s) 7 and/or flange 8.

FIG. 3B Illustrative view of variable diameter retaining sleeve. Sleeve 16 segmented upper flange 17, lower flange 19 and openings 24. Sleeve 16 may be thin flexible one-or more piece distortable insert component. Other embodiments, sleeve 16 may be adhesives, tape, straps, clips, bands, pins or other suitable removable retaining means, that secure and position seam 25 to the inside neck and internal volume of vessel 20.

FIG. 3A Illustrative view lumen tube passing through retaining sleeve and bottom flange positioning annular. Other embodiments sleeve 16 may be joined with annular seam 25 and split along its cylinder length and upper flange 17 is segmented for easer insertion through the neck of vessel 20. Fastening means 26 such as glue or tape, or a removable or permanent adhesive can attach the sleeve 16 to the neck.

FIG. 4 View of enclosed annular seam with lumen tube portion coiled between film layers. Inside perimeter weakened film layer 13 may consist of combinations of layers 12 and/or layers 11 and enclose a length of lumen tube 15, wires cables, within annular seam 25. It is contemplated a sterilization process may be applied to components within film 13 layers before, during, or after seam 25 is formed. Film portions 13 may be perforated allowing communication between selected liners within seam 25. A sterilizing means may be introduced through a lumen tube 15 to surfaces of bag 12 and surfaces of bag 11 prior to system operation.

FIG. 5 Spool type bracer element. A two or more piece bracer assembly. Upper bracer centering ring element 41 may have continuous, segmented, or separated portions. Lower bracer ring centering element 42 may have continuous, segmented or separated lower bracing portions. A two or more piece bracer element assembly may be collapsible, distortable, compressible and may include conductive elements that make or break a circuit limiting excessive injected pressure. An embodiment may include a “pinch off” segment between upper, lower portions of a tapered duct 4. The compression of duct 4 diameter could stop or alter the flow through a primary bag conduit.

FIG. 6 Bracer element, lumen tube coiled around center. A lumen tube 15 a lumen tube coupling component 5 coiled and connected to a lumen tube 15A. Additional electrical connectors, cables, switches sensor couplings RF monitoring components may be coiled around duct 4 in a similar manner.

FIG. 7 Expanded diagram of crown cap, retainer ring, two or more piece bracer element and two or more-egress/ingress conduits fitment flange. An embodiment assembly may include more than one fitment couplings 6 on primary bag 7 fitment flange 8. Conduit duct 4 may have tapered sections securing and/or restricting movement of coupling 6 components. Upper conductive area 39 and lower conductive area 40 may be present on a bracer component and cooperate as an open/close electrical contact. Combinations of element 39 and 40 may communicate through cables, wires, RF (radio frequency) or the like to external control devices. Open top retainer ring 36 interlocks with the neck of a vessel 20 and provides a passageway for lumen tubes, cables wires to exit the vessel. A cover cap 37 may include compression fittings 23 may be liquid-proof an may separate any lumen tubes, cables, wires, probes exiting the vessel. Fittings 23 may be removable “boot type” or other aseptic strain relief type components, and may cover all or part of retainer 36. Securing means 34 may include screws pins, hooks, snaps, “hook, and loop” type fasteners, O rings gaskets, caulking, compression fittings or the like capable of securing cover cap 37 to retainer 36 or the neck of a vessel.

FIG. 8 3D View including a side view drawing with callout, first and second sheet aperture area and lumen tube and cable between sheet surfaces. Liner sheet(s) 12 include an aperture ring region of annular seam 25. Lumen tube portion 15A and cable containing wires 28 between liner(s) 11 and liner(s) 12. Liner sheet(s) 12 ring region subsequently seam to sheet(s) 11 at corresponding aperture ring region. Lumen tube 15A and cable 28 traverse a ring region and are sandwiched between combinations of layers 12 and 11. Weld filler may be provided at component locations when a relatively thin width annular seam 25 is applied. Weld filler material; may have metallic elements and derive from a group of thermoplastics and/or polymers that remain flexible after the polymerization reaction of welding.

FIG. 9 2D Illustration view of annular seam extension portion and weakened film enclosing system components. Weakened film layer 13 may be a separate sheet and enclose system component portions including but not limited to; extension fittings, connectors, electrical contacts, couplings, tubes, wires, etc. These components may be sandwiched between portions of layer 13 and traverse segments of seam 25 and welded with the seam, as a sub. component to a bag-in-bag assembly.

FIG. 10 Stretch out view of multiple piece bracer component, primary bags, and retainer ring. Multiple piece bracer components 50 may include a lower bracer plate 46, bracer body 45, and upper bracer plate 48 or combinations thereof. Bracer components 50 may include provisions for more than one primary bags 2 conduits. Plate 46 may include a divider element 47. Divider 47 may be semi. rigid, flexible, metallic and may extend to a bottom portion of a pressure rated vessel 20 (not shown). When a neckless or near neckless vessel is utilized, lower plate 46 may be semi. rigid or flexible otherwise hinged or distortable to pass through the neck. Plate 46 may be removable, or otherwise affixed to primary bag(s). Bracer body 45 has a height and shape and space for primary bag(s) 2 conduits, lumen tube(s) s 15 and any couplings, connectors, electrical wiring that may be present, to exit the vessel damage free. Some embodiments include upper plate 48 and lower plate 46 metallic such that contact between plates makes electrical connection. Retainer means 36 interlocks with the vessel at the opening, securing the bracer components atop the primary bag(s) 2. Retainer means 36 may be permanent or removable, and provide passage of conduits, lumen tubes, electrical wires, cables, probes to exit a vessel.

FIG. 11 Close up illustration of seam weld and lumen tubes passing between film layers. A section of annular seam 25, may have more than one lumen tube entering different layers. The weld is the common bond area connecting multiple film layers 3 together. Lumen tube 15 and a distortable or compressible tube 29 traverse a portion of seam 25 In some embodiments tube 29, will pass unbroken, thru inner perimeter edge portions of weld 25 and may enter or exit between different or same film layers. In some embodiments where groupings of layers 11 and/or layers 12 are edge seamed as enclosed bags tube 29 may be present at seam 25 to vent gasses from between layers.

FIG. 12 drawing of bag in bag with lumen tubes, film layers configured as enclosable/enclosed bags. One or more liners 11 are bonded in a liquid proof manner to one or more liners 12 at seam 25 including portions of lumen tubes 33 and 52 sandwiched between and/or about edge seams and seam 25. Aperture film layer 49 may be one or more layers. Aperture film 49 may be pierced or cut, perforated, a weakened area, expanded film area, flexible or otherwise “distortable” portions that can house lumen tubes, wires, cables, couplings. In some embodiments where a primary bag is pre-installed (not shown) within bag 11, the primary bag fitment may have one or more part assemblies including a fitment flange 8, and may be glued, welded, compression fitted, or otherwise attached to a film portion of 49.

A portion of a first Lumen tube 52 may be between any film layers and a portion of a first lumen tube 33 may be between any film layers, compose in part a bag in bag portable assembly that may or may not be housed within a vessel (not shown). Lumen 52 may be part of bag seam 38 and sandwiched between any layers of liner 12, and connect to a first enclosed pouch 51. Pouch 51 may be a separate pouch component positioned outside an outer most layer 12. Pouch 51 may be positional between an outermost surface of liner(s) 11 and an innermost surface of liner 12. In some embodiments, the enclosing seam of pouch 51 may include one or more layers of liner 12, as part of the enclosing layers. It is understood that a series of enclosed pouches may be present having lumen tubes configured to communicate with any pouch combinations. Heating or cooling means, reactive substances or combinations thereof may enter or exit enclosed pouch 51. In some embodiments pouch 51 may have a weakened film surface. In some embodiments pouch 51 may include a portion of layer(s) 11, and/or combination of layer(s) 12 as part of enclosable liners. Inner bag seam 53 may include one or more enclosing seams that combine to enclose portions of liner(s) 11. Bag seam 38 may include one or more enclosing seams that combine to enclose portions of liner(s) 12. It can be appreciated that a series and/or groupings of enclosable/enclosed bags, configured in some assemblies one within the other within others is possible.

Referring to FIG. 14 Top view of possible vessel shapes with “slot like” opening a bracer disc element positioned inside. Examples of two possible vessel shapes A, and B. It is contemplated that other shapes such as spherical, cylindrical, or triangular vessel configurations are possible. The inside corners or angles are typically rounded and may have curved smooth protrusions about, enhancing structural integrity. An elliptical oval shape opening 57 to the vessel can be flush with a surface or may have a lip flange or edge structure means for a carry handle. The opening 57 configured “slot like” would allow damage free passage of any bags and/or system components to pass through. In some embodiments a bracer element configured as a disc 54 may include electrical properties such as a peltier device or similar heating cooling means which may include wires 59 with insulated covering 58 configured to fold down such that disc 54 can be inserted edge-wise through opening 57. Element 54 may include channels 62 providing crush resistance passage for wires, lumen tubes 15 to exit the vessel. In some embodiments channels 62 are configured inverted, such that it is meant to compress a lumen tube, limiting or stopping a pressurizing means from entering or exiting the vessel. Bracer element opening 56 may be configured for one or more primary bag conduits. Bracer element 54, may be pressure rated. Bracer 54 may include vibration means, digital display, RF capabilities, mechanical indicators, electrical indicators (switching) and/or electrical sensoring such as but not limited to: temperature, pressure, moisture, volume etc.

FIG. 15 Bracer element disc with raised portion and support element. Bracer element disc 55 may be configured for electrical components similar to 54, and may include raised portion 60, providing an aseptic seal of vessel opening. Portion 60 may include a support means 63 that folds down and allows the user to guide the bracer element through the vessel opening 57, and reposition it within the vessel. When a primary bag has a flexible conduit, the conduit can fold down along with support 63 which then fixes to and stabilizes the conduits and any wires, tubes exiting the vessel. Tabs 61 hold the bracer element 55 fixed at vessel opening. An embodiment: may include a primary bag with a short fitment conduit threaded or welded or otherwise connected to a bracer disc. Subsequently, the bracer and bag pass through the oval shaped opening 57 using support element 63 positioning the primary bag within the socket. A fold-down or swivel metallic component is contemplated, at opening 56. A fitment extension (not shown) may connect by threads or other means at opening 56.

Claims

1. A bag of the isolated pressurization system essentially comprised of;

(a) (one or more) flexible film sheet configured as an enclosable bag including (one or more) inside wall surface and at least (one) opposing wall surface and a first volume and

(b) (one or more) perforation zone at a wall surface area and

(c) (one or more) flexible film layer including opposing surfaces and

(d) (one or more) flexible weld filler corresponding (as) an annular seam shape consisting of variable width and depth, including at least two opposing surfaces and at least two adjacent surfaces and an inside open perimeter area and

(e) (one or more) flexible length lumen tube, including a first end portion and an opposing second end portion and

(f) (one or more) length conductive wire, including a first end portion and an opposing second end portion and

(g) (essentially) (c) and (d), and a portion of (e) and a portion of (f) are (positioned) within a volume of (the) bag.

opposing adjacent surface of weld filler and is enclosed within a said volume of bag.

5. (The) bag of the isolated pressurization system (according to) claim 1 essentially further comprised of;

(a) portion of said conductive wire traverses a segment of said weld filler in a liquid proof manner between said weld filler two opposing surfaces, and whereas a said length portion of conductive wire protrudes from a said inside perimeter surface of said one adjacent surface of weld filler to within said inside perimeter area of weld filler, and whereas a said opposite end portion of (said) conductive wire protrudes from a said opposing adjacent surface of weld filler and is enclosed within a said volume of bag.

6. (The) bag of the isolated pressurization system (according to) claim 1 essentially further comprised of;

(a) said flexible film layer surface portion joins in a liquid proof manner to a said weld filler surface, and whereas the said opposing weld filler surface joins in a liquid proof manner to a said bag wall surface surrounding a said perforation zone area of the bag, and whereas a said lumen tube length portion within said inside perimeter of weld filler is accessible through an open surface portion of perforation zone area outside the bag.

7. (The) bag of the isolated pressurization system (according to) claim 1 essentially further comprised of;

(a) portion of said flexible film layer surface joins in a liquid proof manner to a said weld filler surface, and whereas the said opposing weld filler surface joins in a liquid proof manner to a said bag wall surface surrounding a said perforation zone area of the bag, and whereas a said conductive wire length portion within said inside perimeter of weld filler is accessible through an open surface portion of perforation zone area outside the bag.

8. (The) bag of the isolated pressurization system (according to) claim 1 essentially further comprised of;

(said) flexible film layer surface portions seamed with portions of said bag wall surfaces.

9. (The) bag of the isolated pressurization system (according to) claim 1 essentially further comprised of;

(said) weld filler annular shape consisting of at least one unbroken flexible film surface within the said inside weld filler perimeter area.