Sterile liquid materials distribution, consumption and material waste disposal method and apparatus

The present invention is directed towards a method and apparatus for packaging or containing, handling and managing of a variety of materials or other contents from a variety of sources which encounter use under various dynamic applications, conditions and for a plurality of purposes. The invention more specifically is directed towards one or more containers or packages, suitably fitted or used for the handling or managing of materials or other contents along one or more cycles or chains of use. The one or more packages or other containers described herein is intended for and/or used in one or more interconnections or associations with not only the “initial purpose” filling, transport, storage, dispensing, pouring, using, releasing of sterile or other fluids or material contents, but also used in association with, and for carrying out, the additional delivering and receiving of said fluids or materials, and the receiving and delivering of said fluids or materials via an ingress and egress, by a variety of ways, for a variety of functions and for a plurality of purposes.

FIELD OF THE SUBJECT MATTER

This application relates to the field(s) of supply chains and distribution and consumption of sterile/aseptic liquid/fluent materials. This application also relates to the consumption and collection and disposal chain of waste fluent materials. This subject matter also relates to the manufacturing processes and handling systems for fluent materials packaging in the medical field.

Summary of the Subject Matter/Embodiments

Sterile/Aseptic liquid materials are supplied, consumed and disposed of by a coordinated, manufactured packaging/handling system and structured for connectability as a fluent material disposal packaging/handling system and integrated into/with patient care. The system comprises a supply and disposal chain system and expands “point(s) of consumption(s)” for sterile/aseptic liquid/materials manufacturing and processes. The embodiments of the subject matter disclosed herein comprise interposing passage conduit structures between similar or dissimilar embodiment enclosures of a fluent material handling system. The system also discloses the many applications whereby interposing passage conduit structures between enclosures made from sterile liquid packaging manufacturing processes and other collection and disposal events may have positive impact on the supply and disposal chain associated therewith. The systems enclosure(s) embodiments may be the same enclosure, a different enclosure and the enclosure may function as an origin, source or delivery destination of fluent materials. In this system the patient may function as an origin, source or delivery destination. The passage conduit structures link the delivery of sterile liquid packaging with collection and disposal packaging by interposition there-between, and broaden point of consumption by the interposition there-between and integration with the health care patient. This subject matter also discloses interposing passage conduit structures manufactured and made for the coordinated connectability, coaptibility and interposition between clean/sterile hermetically sealed sterile liquid packaging and other collection like containers and integrates modes of patient care treatment. Supply chain efficiency, and the potential for reducing medical waste, reducing inventory, reducing costs is the innovation of the herein disclosed subject matter/system. The system is a coordinated manufactured system of enclosures and passageway conduit structures, connectable at port structures for the volumetric assessment and/or matching of incoming/distribution of sterile/aseptic liquids with outgoing/disposal materials. The system is intended to address the supply chain. The subject matter/system offers the customer the planning and matching of in and out going fluent materials and the utilization of sterile liquid delivery packaging for collection and disposal of other fluent materials. The system encompasses generally going from clean to dirty, but the subject matter is not limited to that due to reprocessing potential and other circumstances. Points of consumption may be broadened and expansion may be created characterized as going from the supply side to the disposal side by interposing conduit structures there between or, created characterized as going from the disposal side to the supply side by interposing conduit structures there-between, and based on how the system maybe creatively characterized/described. The enclosure/enclosed space of the herein disclosed sterile liquid/aseptic package container embodiments may well be suited for the enclosing/handling of other materials. These enclosures structures, and the passage conduit structures herein disclosed are manufactured with/for conduit structures and coordinated ports structures coordinating the expansion of consumption for coaptability between sterile liquid packaging and broadening consumption to/with other types of packaging and handling of fluent materials. A sterile liquid package of the embodiments disclosed herein have systematized linkability for uses that coordinate the expansion of the points of consumption to supply and disposal and utilized at the creative discretion of the consumer. The goal of the embodiments/innovations disclosed herein are to empower the consumer to have/make creative decisions for supply chain improvements.

Volumetric enclosures provides methods and apparatus for teaching, generating and deriving supply chain efficiency methods and improvement potential. Prime manifold enclosures methods and apparatus provide for deriving and generating efficiency by volumetric displacement and volumetric replacement of dissimilar materials and volumetric displacement and volumetric replacement of material having dissimilar origin. Prime manifold enclosures interposed for cooperative coaptation and flow path communication continuity between gradient matrix flow paths for volumetrically displacing and volumetrically replacing dissimilar materials and volumetrically displacing and volumetrically replacing materials of dissimilar origin. The displacement and replacement of materials may occur from and to a sterile liquid package, hermetically sealed and delivered/distributed with a sterility assurance level required for the delivery of sterile/aseptic liquid packaging to the same package connectable for the disposal of a material not delivered in the package as origin. In process flow continuity embodying volumetric displacement and replacement of distinct/different materials of distinct/different origin interposing manifold/enclosures comprising materials having rigid, and or semi-rigid, and or semi-flexible and or flexible construct characteristics are disclosed for ingressing and egressing fluent materials along gradient pressures flow matrix patterns by the occurrence of differential flow pressures. The embodiment enclosures are interposed along the plow pattern matrices and fluent materials impelled/expelled by pressure gradient inducing events. Flow matrix pressure changes impel/expel fluent materials by any plurality of dynamic causes in the singular or plural sense. structured cooperation/coaptability and flow matrix composite coaptation interposes passage conduit structures between prime manifold enclosures and interposes prime manifold enclosures between variant causes of pressure gradient change resulting in fluent materials impelling conferring efficiency advantages along the associated supply chains. Passage conduit structures manufactured and made for cooperative coaptation and connectability and interposed between the sterile fluent materials package and the collection package, the clean and the dirty, the incoming and the outgoing. New Methods for deriving fluent flow matrix patterns interposing prime manifold enclosures between flow gradient pressure differentials are taught. New Apparatus for generating new matrix patterns comprising fluent materials manifolds cooperatively structured for creating integrated composite communication flow matrix pathways are disclosed. New Supply chain efficiency advantage potential(s) are conferred in part by expansion of traditional points of consumption across the sterile/aseptic/clean enclosure line to the dirty/collection/disposal line, and across distinct traditional disciplines of manufacturing and care by the interposition of prime manifold enclosures between distinct disciplines previously uncoordinated and the interposition of passage conduit structures manufactured for the coordination and management of fluent material across the sterile/clean and collection/dirty barriers.

For example, in a fluent material handling system, for handling dissimilar fluent materials of dissimilar origin and intended for dissimilar delivery destination said system including a supply chain for barrier enclosures therefore, a method of increasing supply chain efficiency comprises the steps of constructing a prime manifold barrier enclosure with port structures for ingress and egress of dissimilar fluent materials, fitting said port structures with passage conduit structures coapted for connecting said enclosure with fluent materials sources and delivery destinations, and displacing and replacing said dissimilar fluent materials from and to said enclosure and said sources and said enclosure and said delivery destinations, whereby supply chain efficiency is increased by reducing supply costs and quantities of said enclosures. The embodiment of this system wherein said barrier enclosure has a variable cubic/volumetric capacity. The embodiment of the system including the further step of collecting one or more waste fluent materials in said enclosure for disposal thereof. The embodiment of this system including the further step of applying/providing printed and graphic symbols instructions and other indica in text graphics and/or images on the surface or along with said embodiment in teaching creative packaging, conservation re-cycling supply chain efficiency and environmental awareness. The embodiment of this system wherein said displacing and replacing step occurs and or is controlled by application of differential pressure between said barrier enclosure and said sources and said delivery destinations. The embodiment of this system wherein said displacing and replacing step is affected by the force of gravity. The embodiment of this system wherein said barrier enclosure is constructed from rigid material. The embodiment of this system wherein said barrier enclosure is constructed from semi-rigid material. The embodiment of this system wherein said barrier enclosure is constructed from semi-flexible material. The embodiment of this system wherein said barrier enclosure is constructed from flexible material. The embodiment of this system wherein said fluent material handling system is applied to fluent materials in human health care procedures. The embodiment of this system wherein said fluent material handling system is applied to a continuum of care procedures for a health care patient.

In another embodiment example in a fluent material handling system for handling dissimilar fluent materials of dissimilar origin and intended for dissimilar delivery destinations said system including supply and disposal chain for said fluent materials and barrier enclosures therefore, a method of increasing supply and disposal chain efficiency potential comprising the steps of, constructing a prime manifold barrier enclosure with a plurality of ports for ingress and egress of dissimilar fluent materials, fitting said port structures with passage conduits coapted for connecting said enclosure with dissimilar sources and delivery destinations for dissimilar fluent materials, displacing and replacing said dissimilar fluent materials from and to said enclosure and said dissimilar sources and delivery destinations, collecting one or more fluent materials in said enclosure, conditioning said enclosure and said waste fluent material for disposal, whereby supply and disposal chain efficiency potential is increased by reducing supply costs and quantities of said enclosures, quantities and costs of disposal of said enclosures and waste fluent materials and environmental impact therefrom. The method of this embodiment wherein said enclosure has variable cubic/volumetric capacity. The method of this embodiment enclosure wherein said displacing and replacing step is controlled by application of differential pressures between said barrier enclosure and said sources and said delivery destinations. The method of this embodiment wherein said displacing or replacing step is effected by the force of gravity. The method of this embodiment wherein said barrier enclosure is constructed from rigid material. The method of this embodiment wherein said barrier enclosure is constructed from semi-rigid material. The embodiment of this enclosure wherein said enclosure is constructed from semi-flexible material. The method of this embodiment wherein said barrier enclosure is constructed from flexible material. The method of this embodiment wherein said fluent material handling system is applied to fluent materials in human health care procedures. The method of this embodiment wherein said fluent materials handling system is applied to a continuum of care procedures for health care patient(s). The method of this embodiment for creating supply and disposal chain efficiency.

In another embodiment example a method of handling dissimilar materials of dissimilar origin comprising the steps of constructing a prime manifold enclosure with port structures for ingress and egress of dissimilar fluent materials, fitting said port structures with passage conduit structures coapted for connecting said enclosure with fluent material sources, displacing and replacing said dissimilar fluent materials from and to said enclosure and said sources, whereby supply chain efficiency for said enclosures is increased by reducing supply costs and quantities. A method of this embodiment wherein said barrier enclosure has a variable cubic capacity. A method of this embodiment including the further step of collecting one of more waste fluent materials in said enclosure for disposal thereof. The method of this embodiment including the further step of providing and or applying printed and or graphic symbols, instructions and other indica with, on the surface or provided with said enclosure teaching conservation, recycling supply chain efficiency and environmental awareness. The method of this embodiment wherein said displacing and replacing step is controlled and/or occurs by application of differential pressure between said barrier enclosure and said sources and said delivery destinations. The method of this embodiment wherein displacing and replacing step is controlled by application of differential pressure between said barrier enclosure and said sources and said delivery destinations. The method of this embodiment wherein said displacing and replacing step is effected by the force of gravity. The method of this embodiment wherein said barrier enclosure is constructed from rigid material. The method of this embodiment wherein said barrier enclosure is constructed from semi-rigid material. The method of this embodiment wherein said enclosure is constructed from semi-flexible material. The method of this embodiment wherein said enclosure is constructed from flexible material. The method of this embodiment wherein said fluent material handling system is applied to fluent materials in human health care procedures. The method of this embodiment wherein said fluent material handling system is applied to a continuum of care procedures for health care patient(s). The method of this embodiment for creating supply and disposal chain efficiency.

In another embodiment example a method of handling dissimilar fluent material of dissimilar origin intended for dissimilar destinations comprising the steps of constructing a prime manifold barrier enclosure with a plurality of ports for ingress and egress of dissimilar fluent materials, fitting said port structures with passage conduits coapted for connecting said manifold barrier enclosure with dissimilar sources and dissimilar delivery destinations for dissimilar fluent materials, displacing and replacing said dissimilar fluent material from and to said enclosure and said dissimilar sources and delivery destinations, collecting one or more waste fluent materials in said enclosure and conditioning said enclosure and said waste fluent material for disposal, whereby supply and disposal chain efficiency is increased by reducing supply costs and quantities of said enclosures, quantities and costs of disposal of said enclosures and waste fluent materials and environmental impact therefrom. The method of this embodiment wherein said barrier enclosure has a variable cubic/volumetric capacity. The method of this embodiment wherein said displacing and replacing step is controlled/occurs by application of differential pressures between said barrier enclosures and said sources and said delivery destination. The method of this embodiment wherein said displacing and replacing step is effected by the force of gravity. The method of this embodiment wherein said barrier enclosure is constructed from rigid material. The method of this embodiment wherein said barrier enclosure is constructed from semi-rigid material. The method of this embodiment wherein said barrier enclosure is constructed from semi-flexible material. The method of this embodiment wherein said barrier enclosure is constructed from flexible material. The method of this embodiment wherein said fluent material handling system is applied to fluent materials in human health care procedures. The method of this embodiment wherein said fluent material handling system is applied to a continuum of care procedures for a health care patient(s). The method of this embodiment for creating supply and disposal chain efficiency.

Another embodiment example comprising a fluent material handling system for dissimilar fluent material of dissimilar origin and intended for dissimilar delivery destinations comprising, a prime manifold barrier enclosure with port structures for the ingress and egress of said dissimilar fluent materials, passage conduit structures operatively associated with said barrier enclosures and coapted for selectively connecting said barrier enclosure with sources of said dissimilar fluent materials and said delivery destinations, and, means for selectively creating material movement between said sources of fluent material and said barrier enclosure and said delivery destinations. The apparatus of this embodiment wherein said fluent material handling system is applied to fluent materials in human health care procedures. The apparatus of this embodiment wherein said fluent material handling system is applied to a continuum of procedures for a health care patient. The apparatus and methods of this embodiment for creating supply and disposal chain efficiency.

Another embodiment example in a supply chain for dissimilar fluent material and barrier enclosures therefore, said fluent materials having dissimilar origins and being intended for dissimilar destination, a fluent material handling system comprising a prime manifold barrier enclosure with a plurality of ports fro ingress and egress of dissimilar fluent materials, passage conduit structures operatively associated with said barrier enclosures and copated for selectively connecting said barrier enclosures with sources of said dissimilar fluent material and said delivery destinations and means for selectively creating material movement between said sources of fluent material and said barrier enclosures and said barrier enclosures and said delivery destinations to selectively displace and replace dissimilar fluent materials therebetween, whereby a reduce number of barrier enclosures required to perform a plurality of separate procedures involving dissimilar fluent materials having dissimilar origin to thereby increase supply and disposal chain efficiency of said dissimilar fluent materials and said barrier enclosures. The apparatus of this embodiment wherein said barrier enclosure has a variable cubic/volumetric capacity. The apparatus of this embodiment wherein said displacing and replacing step is controlled by application of differential pressure between said barrier enclosure and said sources and said delivery destination. The apparatus of this embodiment wherein said displacing and replacing step is effected by the force of gravity. The apparatus of this embodiment wherein said barrier enclosure is constructed from rigid material. The apparatus of this embodiment wherein said barrier enclosure is constructed from semi-rigid material. The apparatus of this embodiment wherein said barrier enclosure is constructed from semi-flexible material. The apparatus of this embodiment wherein said barrier enclosure is constructed from semi-flexible material. The apparatus of this embodiment wherein said barrier enclosure is constructed from flexible material. The apparatus of this embodiment wherein said flexible material handling system is applied to fluent materials in human health care procedures. The apparatus of this embodiment wherein said fluent materials handling system is applied to a continuum of care procedures for a health care patient. The apparatus of this embodiment including the further step of applying and providing printed and graphic symbols and instructions and other indica on the surface, unitary therewith, or with said barrier enclosure teaching conservation, recycling, supply chain efficiency and environmental awareness. The method and apparatus of this embodiment for creating supply and disposal chain efficiency.

DESCRIPTION OF THE INVENTION

Terms used in the disclosure of the invention are defined as follows:Egress: an act, or right of going out; to go out.Orientation: choice or adjustment of associations, connections, or dispositions as they relate to a relative position.Ingress: to go in.Plurality: a state of being plural; at least more than one.Flow: to cause to flow; material movement.Control: to exercise restraining or directing influence over; an act or fact of controlling; a means
or method of controlling.Communication: an act or action of imparting or transmitting; access between places.Supply: an act, process, or an instance of filling a want or need or of providing someone or something. Chain: a series of events in a temporal order usually connected causally.Consumption: the utilization of economic goods in the satisfaction of wants.Disposal: an act or process of disposing.Waste: thrown away or aside as worthless.Material: of, relating to, or consisting of matter.Dispense: administer.Container: one that contains.Efficiency: the power, characteristic quality, or manner of operation of an efficient cause.

The object(s) of the invention . . .

DESCRIPTION OF THE DETAILED DRAWINGS

InFIG. 1, embodiment1has three port structures2. One port structure is attached to cap closure4. Embodiment1has width2-6and width1-7and length13. Variable height portion8, allows for the enclosure barrier to have different heights/volumes and still fit within the holder ofFIG. 18. Embodiment1has incremental marking17so that fluent material flow rate may be monitored. Embodiment enclosure1also has anti-motion strut10of sufficient width11to maintain anti-motion support. Anti-motions strut10has pin hole12. Embodiment enclosure1has two width's whereby width1-7changes to width2-6at9producing a differential dimension ledge at9. This ledge forms a support9and contact point around the edge periphery making a contact point about the embodiment to be held in the aperture of the support holder ofFIG. 18.

FIG. 2comprises enclosure embodiment14having three port structures each15one port structure15is attached to cap16. Embodiment enclosure14has two widths19&18, width218and width1-19and has length27. Width1-19meets width2-18at21, creating differential dimensions at21, the differential dimensions on each side of the embodiment enclosure forming the ledge(s) for support of embodiment14for fitting and being held by the support holder ofFIG. 18. Embodiment14has variable height26for different manufacturable volumes of the embodiments having different overall heights and still fit within the holder support ofFIG. 18. Embodiment14has incremental markings17so that the rate of fluent material flow may be visualized. Anti-motion struts supports25having sufficient width24, and pin hole23, and similar to anti-motion strut10ofFIG. 1may be unitary to the enclosure or may be attached. Pin hole23of anti-motion strut/support25allow pinning and further securing to the lower holder structure ofFIG. 20.

The embodiment ofFIG. 3comprises passage conduit structure having an enlarged portion31with incremental marking32for the visualization of fluent flow rate changes. Enlarged conduit portion31, having length30and incremental marking32is also make of transparent clear materials. Structure28may be associated with a urinary drainage catheter or the like and structure34may be associated with the enclosure38. Passage conduit structure33may be fitted to a stopcock of valve at A, to stop flow near the enclosure barrier connection site so that fluent material drainage flow may rise in the enlarged portion31to monitor drainage output such as would be the case in using a urimeter, but in this embodiment the enlarged portion31functions as an in line urimeter. Junction A may comprise a stopcock or a valve or any other similar means of occluding passage of fluent materials during the period for which metering is desired. Similarly, simply clamping passage conduit structure at B may effect the same occlusion during the period for which occlusion is required. The enclosure barrier embodiment ofFIG. 3has port structure36manufactured for coaptibility and connectability to the passage conduit structure ofFIG. 3.

FIG. 4shows another embodiment of a passage conduit structure43, having enlarged portion41and enlarged height portion42. The enlarged portion has incremental marking for visualization and metering the rise of fluent material flow rates. The passage conduit structure ofFIG. 4may be associated with a urinary drainage catheter at39, or a wound catheter at39and connected to an enclosure barrier at45.FIG. 4is show to have the same stopcock, valve, or other flow occlusion means as depicted at B.

FIG. 5comprises an embodiment of passage conduit structure55, a portion of which said structure has incremental markings56along length portion54of said conduit structure and intended to function as an inline fluent flow meter (in line urimeter but not limited to that) for measuring/metering the fluent material rise rate for determining the volume/rate of fluent material flow. Passage conduit structure55may be clamped at B to occlude fluent flow effecting the flow rise along conduit length54and incremental markings56may used to determine the flow rate as desired and functioning as an inline fluent material flow meter (inline urimeter but not limited to that).

FIG. 3FIG. 4, andFIG. 5show passage conduit structures having transparency and being made of materials clear enough for visualization of fluent materials rise along lengths30,42, and54of the passage conduit structures shown.

FIG. 6,FIG. 7, andFIG. 8respectively each show enclosure barriers69,69aand83, manufactured with port structures for coaptive connectability to passage conduit structures65,71, &77. The passage conduit structures having ends66,72&78manufactured for coaptive connectability to port structures of enclosures69,69aand83at one end and intended for receiving materials from coaptive connectability to a urinary bladder drainage catheter, a wound drainage catheter or from a source-origin-delivery-destination or a health care patient as shown inFIGS. 21 through 26.

FIG. 6a,7a&8ashow embodiment enclosures84,100&101each having port structures87,94and103and manufactured for coaptive connectability to passage conduit structures88,96and104. Enclosures84,100&101are manufactured for coaptive connectability to origins sources and delivery destinations and patients as shown in the schematics ofFIGS. 21 through 26and are intended to for coactive connectability to intravenous access through end structures90,98&106. Formularies, anesthesia agents, pharmaceutical preparations, mixing of drugs and preparations and administering and dosing treatments may take place along passage conduit structures89a& b,97a&band105a&bor may take place at the sites of enclosures embodiment structures84,100and101.

FIG. 11shows embodiment of enclosure holder125which is fashioned to be held by resting/holding ring126. Ring support125a125band125care structurally attached to ring125. Barrier enclosure132slidable engages the vertical enclosure supports of125a125band125c.

FIG. 12shows barrier enclosure139in resting position within ring holder125. Enclosure139has ports structures142,141and140positioned and accessible for access to passage conduit structures. Vertical support138,136and137slidably engage anti-motion grips as shown inFIGS. 9 and 113and114and as shown inFIGS. 10as121and122. The slidably engagable grip system fit is shown more visibly in blow upFIG. 13whereby anti-motion grip114m113and121and122are placed in slidable engagement with vertical support136forming a key and key hole/keyway sliding relationship.

FIG. 16shows an alternative embodiment of anti-motion struts. Barrier enclosure157has port structures158and159&160and has anti-motion supports156and155and154. Stability pin151,152, and153are mounted to support150and are located and position to accept the holes associated with enclosure157and racked/placed on holder150as the pins are placed through the holes as depicted inFIG. 15.

FIG. 15is a close up of anti-motion support162having hole166and may be made unitary or associated with enclosure housing wall161. The close up ofFIG. 15shows the pin and hole relationship of pins151,152,153and how they would be used in pinning holes156,155, and154as positioned around enclosure157for anti-motion support means. This engagement creates a plurality of anti-motion support for enclosure157.

FIG. 19shows embodiment enclosure199having anti-motion supports205which has pinning holes204. Enclosure199also has width1-206and width2-203. Embodiment enclosure199slidably fits into holder212. Holder212conveniently fits onto ring213. Lower support214is slotted as shown in blow upFIG. 20a. Lower motion support205has pin hole214awhich may be conveniently aligned with anti-motion support pin hole204and pin for anti-motion stability.FIGS. 17,18,18a, andFIGS. 19,20and20aare intended to show alternative enclosure holding methods and apparatus for enclosure embodiments ofFIG. 1andFIG. 2. The change in width from width1(7,19,169,206) to width2(6,18,FIGS. 17-168,FIGS. 19-203,FIG. 20W2) creating a ridge or resting ledge for contact support to contact surface/stop191whereby enclosure portion199ofFIG. 19may rest above the surface of aperture support191ofFIG. 18.

FIGS. 21 through 26show the interrelationship and integration of the distribution and delivery utilization sterile liquid/aseptic packaging manufacturing processes with/to the collection and disposal of fluent materials as described and disclosed in this application. The embodiments, apparatus and methods herein disclosed are intended for creative integration and utilization for the maximum desired/created application for supply chain efficiency potential.