US20120241465A1 - Dispensing device along with method for dispensing product - Google Patents
Dispensing device along with method for dispensing product Download PDFInfo
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- US20120241465A1 US20120241465A1 US13/393,490 US201013393490A US2012241465A1 US 20120241465 A1 US20120241465 A1 US 20120241465A1 US 201013393490 A US201013393490 A US 201013393490A US 2012241465 A1 US2012241465 A1 US 2012241465A1
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- United States
- Prior art keywords
- package
- backing
- compartment
- fluid transport
- transport device
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Classifications
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D83/00—Containers or packages with special means for dispensing contents
- B65D83/0055—Containers or packages provided with a flexible bag or a deformable membrane or diaphragm for expelling the contents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
- A61M5/281—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle using emptying means to expel or eject media, e.g. pistons, deformation of the ampoule, or telescoping of the ampoule
- A61M5/282—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle using emptying means to expel or eject media, e.g. pistons, deformation of the ampoule, or telescoping of the ampoule by compression of deformable ampoule or carpule wall
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
- B05B—SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
- B05B11/00—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use
- B05B11/0005—Components or details
- B05B11/0027—Means for neutralising the actuation of the sprayer ; Means for preventing access to the sprayer actuation means
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
- B05B—SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
- B05B11/00—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use
- B05B11/0005—Components or details
- B05B11/0078—Arrangements for separately storing several components
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
- B05B—SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
- B05B11/00—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use
- B05B11/01—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use characterised by the means producing the flow
- B05B11/04—Deformable containers producing the flow, e.g. squeeze bottles
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
- B05B—SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
- B05B11/00—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use
- B05B11/01—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use characterised by the means producing the flow
- B05B11/04—Deformable containers producing the flow, e.g. squeeze bottles
- B05B11/041—Deformable containers producing the flow, e.g. squeeze bottles designed for spraying particulate material
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
- B05B—SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
- B05B11/00—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use
- B05B11/01—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use characterised by the means producing the flow
- B05B11/04—Deformable containers producing the flow, e.g. squeeze bottles
- B05B11/048—Deformable containers producing the flow, e.g. squeeze bottles characterised by the container, e.g. this latter being surrounded by an enclosure, or the means for deforming it
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D35/00—Pliable tubular containers adapted to be permanently or temporarily deformed to expel contents, e.g. collapsible tubes for toothpaste or other plastic or semi-liquid material; Holders therefor
- B65D35/24—Pliable tubular containers adapted to be permanently or temporarily deformed to expel contents, e.g. collapsible tubes for toothpaste or other plastic or semi-liquid material; Holders therefor with auxiliary devices
- B65D35/28—Pliable tubular containers adapted to be permanently or temporarily deformed to expel contents, e.g. collapsible tubes for toothpaste or other plastic or semi-liquid material; Holders therefor with auxiliary devices for expelling contents
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D35/00—Pliable tubular containers adapted to be permanently or temporarily deformed to expel contents, e.g. collapsible tubes for toothpaste or other plastic or semi-liquid material; Holders therefor
- B65D35/24—Pliable tubular containers adapted to be permanently or temporarily deformed to expel contents, e.g. collapsible tubes for toothpaste or other plastic or semi-liquid material; Holders therefor with auxiliary devices
- B65D35/36—Pliable tubular containers adapted to be permanently or temporarily deformed to expel contents, e.g. collapsible tubes for toothpaste or other plastic or semi-liquid material; Holders therefor with auxiliary devices for applying contents to surfaces
- B65D35/38—Nozzles
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
- B65D75/52—Details
- B65D75/58—Opening or contents-removing devices added or incorporated during package manufacture
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
- B65D75/52—Details
- B65D75/58—Opening or contents-removing devices added or incorporated during package manufacture
- B65D75/5861—Spouts
- B65D75/5872—Non-integral spouts
- B65D75/5877—Non-integral spouts connected to a planar surface of the package wall
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
- B65D75/52—Details
- B65D75/58—Opening or contents-removing devices added or incorporated during package manufacture
- B65D75/5861—Spouts
- B65D75/5872—Non-integral spouts
- B65D75/5883—Non-integral spouts connected to the package at the sealed junction of two package walls
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/3129—Syringe barrels
- A61M2005/314—Flat shaped barrel forms, e.g. credit card shaped
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/30—Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
Abstract
A device for storing and dispensing a product comprising: a package comprising at least a first compartment having a flexible wall portion; a fluid transport device; and a backing associated with said package which, during dispensing, supports the package to facilitate expression of a product from the package through said fluid transport device.
Description
- The present disclosure relates to a device for dispensing a prefilled product. More particularly the present disclosure relates to device for dispensing a prefilled product comprising a unit-dose prefilled package where the product of said package is stored in one or more film or foil compartments.
- A device for storing and dispensing a product comprising a pre-filled unit-dose package comprising at least a first flexible wall and having at least a first compartment prefilled with dispensable fluid; at least one rigid backing, and a fluid transport device for transferring the product from said fluid compartment to a target location in a desired fashion. Prior of use, said product is hermetically separated from said fluid transport device by a frangible outlet seal. The frangible seal is broken to establish fluid communication between the dispensable fluid and the fluid transport device. The arrangement is such that said rigid backing is manipulated to squeeze said package thereby causing said dispensable fluid to dispense through the fluid transport device.
- The present disclosure relates to the field of dispensing packages in which the package is constructed from portions of films or foils (together here after sometimes referred to as “webs”) hermetically sealed about the perimeter of at least one chamber; and means to for rupturing said chamber to allow the content of said package to be dispensed.
- U.S. Pat. No. 5,131,760 discloses a package which may contain a fluid material which is capable of being discharged from the package by the application of manual pressure from a thumb and forefinger to the package causing the package to burst in a controlled fashion to discharge the fluid material contained within the package. The package comprises a chamber which receives the fluid material discharged from a containing chamber after the containing chamber is burst by manual pressure, so as to control the rate and manner of discharge of the fluid material from the package. One disadvantage of the device taught by U.S. Pat. No. 5,131,760 is that the size of the package is substantially large to begin with and is further expanded when the containing chamber is merged with an outlet chamber. This makes it challenging to efficiently express the content of the package by directly depressing the flexible walls with the fingers or the palm. It is therefore desired to have a dispensing package having a more effective and practical expression capabilities. Furthermore U.S. Pat. No. 5,131,760 does not disclose a fluid transport device such as a hypodermic needle or a nozzle at the exit of the package, thus limiting its applications,.
- U.S. Pat. No. 5,176,634 and U.S. Pat. No. 6,203,535 each discloses a flexible container for the storage and mixing of diluents and medicaments. The container incorporates multiple compartments, separated by frangible seals, in which the diluents and medicaments are stored. The seals are ruptured by manipulation of said container to mix the contents. An additional frangible seal separates the merged diluents and medicaments compartment from the outlet compartment which for delivery through a standard IV arrangement to a patient. These patents teach embodiments for gravitational IV applications and would have several short comings in unit-dose dispenser applications (e.g., where the dispensable fluid volume is smaller than 5 ml but would more likely be closer to 0.5 ml): As discussed above in the shortcomings of U.S. Pat. No. 5,131,760, the merger of the outlet compartment with the dispensable fluid compartment increasing the package size that needs to be depressed to dispense the contact making it inconvenient to perform efficiently. In the above invention the rupture of the frangible seal is achieved by folding the diluents compartment to pressurize the dispensable fluid compartment. While this folding approach may be practical in some embodiments of the present disclosure as will be demonstrated it is generally impractical for diluents compartments as small as 2 ml and in some embodiments as small as 0.5 ml. Furthermore U.S. Pat. No. 5,176,634 and U.S. Pat. No. 6,203,535 do not disclose means for forced delivery of the content.
- U.S. Pat. No. 4,955,871 discloses a single-use disposable syringe. In the syringe, a product compartment is formed of two flexible sheets of thermoplastic material having expanded central portions that form a pair of convex domes. Both of the domes are compressible by directly applying force with two fingers. A product based on this invention is currently commercialized by Becton Dickinson and Company (Franklin Lakes, N.J.) under the product name Uniject™.
- The expression rate of the dose contained within this syringe depends on the physiology of the user's finger pads and the form of depression of the fingers on the package; thus complete or consistent dose delivery can not be ensured. Another disadvantage of this embodiment is that the device is held at its one end between two fingers while the needle is fixed at the other end of the device with only films communicating between the two ends. Therefore the control of the needle and the firmness in the user hand is limited.
- In the present disclosure the fluid transport device has the firmness and precision by incorporating a rigid backing that communicates the user hand and the fluid transport device through a rigid backing.
- The present disclosure preferably discloses a pre-filled unit-dose product dispensing device comprising a package comprising at least one flexible wall and having at least one substance compartment prefilled with dispensable fluid; at least one rigid backing, and a fluid transport device for transferring the product from said fluid compartment to a target location in a desired fashion. Prior to use, the dispensable product is hermetically separated from the fluid transport device by a frangible outlet seal (hereafter sometimes referred to as “outlet seal”). At the point of use the outlet seal is broken to establish fluid communication between the dispensable product and the fluid transport device. The arrangement is such that said rigid backing facilitates efficient expression of the product from said package through the fluid transport device.
- In the present disclosure a dispensable fluid compartment is squeezed directly or indirectly by pressing with the fingers on the flexible walls of a dispensable fluid compartment. The “footprint” of the compartment can be regarded as the actual area of the compartment that would need to be squeezed to efficiently expel the content of said compartment. In many flexible wall packages construction the “footprint” is the perimeter of the dispensable fluid compartment about where said flexible wall is sealed to a second wall.
- The package comprises at least one flexible wall that can be depressed to pressurize the product in at least one compartment of the package. Expression of the product from the package can occur by direct depression of the flexible wall against the rigid backing or by an instrument such as a compression panel that depresses the flexible wall against the rigid backing. The flexible wall is sealed about a perimeter of at least one compartment to at least one additional wall, to form two types of seals: a permanent seal and a frangible seal. The permanent seal is applied about the perimeter of the compartment(s) except where the seal needs to be ruptured to establish fluid communication between said compartment and an adjacent compartment or a compartment and a fluid transport device. U.S. Pat. No. 6,203,535, U.S. Pat. No. 5,176,634 and U.S. Pat. No. 5,131,760 disclose materials and methods for forming flexible packages with a combination of frangible and permanent seals and are incorporated herein by reference in their entirety. One multi-layer film material suitable for making a frangible seal and a permanent seal in designated areas of the package in a controlled fashion is X203-2113-L from PerfecSeal (Oshkosh, Wis.). The adhesive layer of this material will form an hermetic yet weak bond at about 130° C. and a strong permanent bond when sealed at about 170° C. In some embodiments the package comprise numerous compartments, containing different substances of the dispensable product, separated by frangible seals which are ruptured such that during operation the compartments are merged and substances can be mixed into the dispensable product. In some embodiments at least one of said compartments contains a diluent and at least one of said compartments contains dry substance; the dry substance can be in a form of loose flowing powder, compressed powder, granules, pellets, solid, pill, lyophilized cake, coating attached to a solid matrix, dry substance associated to a solid matrix, etc; In some embodiments at least one compartment contains diluents and at least one additional compartment contains a vaccine or a medication in a dry form. The compartments are merged prior to dispensing, in order to reconstitute the vaccine or medication.
- The fluid transport device can be any mechanism suitably for transporting the product from the package to a target location in a preferred form. The fluid transport device can be formed in or between the walls of the package, or it can be a part or an assembly associated with the package as an insert or a fitment. Alternatively the fluid transport device can be implemented between a flexible wall and the rigid backing, or implemented in, or as an attachment to, the rigid backing. The fluid transport device can be in various forms and fashions such as a: dropper; spray nozzle; topical, optalmic, nasal, or ear applicator, dropper or sprayer; a brush, sponge, or other absorbent media for spreading the content to a surface; a tube, a canula, or capillary tube; a needle, a rigid or flexible canula or other sharp object for penetrating a tissue; a connector, a Luer Slip connector, a Luer Lock connector, for communicating with a fluidic system; a combination of the above; an extension, coupler, or connector to one of the above; etc.
- The rigid backing may be made of at least one rigid member against which the package can be squeezed to cause the product to expel through the fluid transport device. In some embodiments the rigid backing also supports squeezing of at least one compartment of the package causing several compartments to merge prior to delivery or to cause the outlet seal to rupture and establish fluid communication with the fluid transport device. The rigid backing further provides firm physical communication between the hand of the user and the fluid transport device, such that a user holding the rigid backing will have precise and sensitive control on moving and positioning the dispensing end of the fluid transport device, which is particularly important when the fluid transport device is a hypodermic needle, eye dropper or any other fluid transport device that requires sensitivity and precision in handling.
- In some embodiments the package is permanently attached to the rigid backing. In other embodiments the package is attached to the rigid backing at the point of use.
- In some embodiments the rigid backing provides one of the walls of the package.
- In some embodiments the rigid backing provides protection to and from the fluid transport device before and after use.
- In some embodiments the rigid backing accommodates a flow regulator for preventing the dispensable fluid from bursting through the fluid transport device when the package is ruptured.
- In some embodiments the rigid backing accommodates a check valve for preventing backflow from the fluid transport device into the package.
- In another embodiment a peelable flexible cover as proposed in U.S. Pat. No. 6,203,535 is attached to the surface of the package and covers at least part of the compartment(s) to further reduce light exposure of the product or substances and reduce oxygen or humidity transfer from and to the package.
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FIG. 1 illustrates a preferred embodiment where the package comprises a single compartment, and the fluid transport device is an inserted fitment having a fashion of a Luer Slip connector; -
FIG. 2 illustrates a preferred embodiment where the package comprises two compartments separated by a frangible seal, with the fluid transport device is an inserted fitment being in a fashion of a Luer Slip connector; -
FIG. 3 illustrates a further preferred embodiment where the package comprises two compartments, each connected to the fluid transport device through a separate outlet seal; -
FIG. 4 illustrates a further preferred embodiment where the fluid transport device is an external fitment attached to a wall of the package; -
FIG. 5 illustrates a further preferred embodiment where the fluid transport device is formed by the walls of the package. The package comprises two sheets of material sealed together about a perimeter of the compartments; -
FIG. 6 illustrates a further preferred embodiment where the package comprises one sheet of material sealed to the backing about a perimeter of the compartments; -
FIG. 7 illustrates a further preferred embodiment where the fluid transport device is created between the package and the backing; -
FIG. 8 illustrates a further preferred embodiment where the fluid transport device is embedded between the package and the backing and where the package comprises multiple compartments; -
FIG. 9 illustrates a further preferred embodiment where the fluid transport device is embedded in the backing; -
FIG. 10 illustrates a further preferred embodiment where the fluid transport device is a hypodermic needle which communicates with the package through a plastic hub; -
FIG. 11 illustrates a further preferred embodiment where the fluid transport device is a hypodermic needle which communicates with the package without a plastic hub; -
FIG. 12 illustrates a further preferred embodiment where the device comprises a sterile needle wrap; -
FIG. 13 illustrates a further preferred embodiment which comprises a fluid transport device destruction mechanism at the end of the use; -
FIG. 14 illustrates a further preferred embodiment where the backing comprises a spring feature for biasing the compression panel in a desired position relative to the backing; -
FIG. 15 illustrates a further preferred embodiment comprising a latching arm for limiting movement of the compression panel relative to the backing; -
FIG. 16 illustrates a further preferred embodiment where the package is not attached to the surface of the backing; -
FIG. 17 illustrates a further preferred embodiment where the device comprises a flow regulator; and -
FIG. 18 illustrates a further preferred embodiment where the reservoir product compartment is positioned over a fold line in the backing. -
FIG. 19 illustrates a further preferred embodiment which does not include a compression panel. - In reference to
FIG. 1 , a preferred embodiment of the device preferably in the form of a prefilled unit-dose dispensing package of the present disclosure present disclosure (hereafter “the device”) 10 is illustrated.FIG. 1 a and its detail view inFIG. 1 b generally illustrate general view of thedevice 10 prior to activation. Thedevice 10 generally incorporates apackage 9 comprising aproduct compartment 12, partially defined by aflexible wall 11, is prefilled with a dose of a dispensable product; afluid transport device 14 for communicating the product to a target location in a desired fashion; and arigid backing 16 supporting thepackage 9. The backing 16 joined with acompression panel 17 through ahinge 18. Thecompression panel 17 can be manipulated to rotate along thehinge 18 and depress thecompartment 12 and cause said product to dispense through thefluid transport device 14. Thedevice 10 further comprises afrangible outlet seal 13 which, until activation, hermetically separates the dispensable product in thecompartment 12 from thefluid transport device 14, said outlet seal is rupturable when theproduct compartment 12 is pressurized beyond a predefined pressure threshold. The firstflexible wall 11 is permanently seals along a firstperipheral margin 15 of saidfirst compartment 12 and non-permanently sealed along a second peripheral margin of saidfirst compartment 12 to define afrangible outlet seal 13 located between saidproduct compartment 12 and saidfluid transport device 14 such that, when said outlet seal is ruptured, a fluid communication is established between product and saidfluid transport device 14. In one embodiment the arrangement is such that by depressing thepackage 9, a pressure develops in theproduct compartment 12 which causes theoutlet seal 13 to rupture by separating the frangible seal between the firstflexible wall 11 and a second wall of thecompartment 12, establishing fluid communication of the product with thefluid transport device 14, thereby activating thedevice 10 to dispense the product to a target location in a defined fashion. Thecompartment 12 can be squeezed directly by a thumb, or by folding thecompression panel 17 over therigid backing 17, such that thepackage 9 is sandwiched between saidcompression panel 16 and thebacking 17,. Alternatively thepackage 9 can be depressed by another machine or apparatus, made to operate said device or by other means as appropriate. - The
package 9 comprises at least oneflexible wall 11 made from a thin laminate (commonly referred to as “web”) such as a film or a foil sealed about the perimeter of saidproduct compartment 12, having a seal on oneportion 13 of said perimeter which will separate under pressure in theproduct compartment 12, while the rest of theseal 15 is a permanent seal that will not separate under that threshold pressure. Thepermanent seal 15 continuous along theoutlet seal 13 such that when theoutlet seal 13 is ruptured a fluid passageway forms and strictly communicates the dispensable fluid with thefluid transport device 14. - In some embodiments the
flexible wall 11 is sealed directly to therigid backing 19 such that theproduct compartment 12 and theoutlet seal 13 are formed between therigid backing 19 and theflexible wall 11. - In another embodiment the
package 9 is established by theflexible wall 11 sealed to at least one additional wall (not shown) such that thecompartment 12 and theoutlet seal 13 are formed interposed between theflexible wall 11 and said additional wall. The advantage of such embodiment is that the package can be produced on a more common Form-Fill-Seal or Fill-Seal line and introduced to the backing at a subsequent manufacturing stage. - In another embodiment a combination of certain foregoing embodiments is made such that the
compartment 12 and theoutlet seal 13 are formed partly between theflexible wall 11 and therigid backing 16, and partly between theflexible wall 11 and at least one additional wall. - The rigid backing comprises a
rectangular flap 16 joined along one edge with and arectangular compression panel 17, via a thin flexible section which forms ahinge 18, and defines a fold line. Depending on the application requirements and the preferred form of manufacturing, thehinge 18 can be produced as a molded living hinge or in other forms and types of rotating hinges or flexible joints solutions known in the art. Therigid backing 16 can be made of various materials and in various processes including molded plastic, plastic sheet or board (single layer, multi-layer, extruded, blown, laminated, etc.), sheet metal, cast alloys, paper board, composite materials, ceramics, or a combination of the above. In some embodiments the livinghinge 18 can be molded integrally with the backing. In other embodiments thebacking 16 and the compression panel can be made as one integral molded part. When backing 16 is made from a sheet or a board the thin section for forming the living hinge can be formed by locally cutting out (machining, evaporating, laser cutting, etc.) part of the wall thickness along the designated fold line, selectively removing specific materials from the composition of the bulk material (such as removing a thermoplastic resin by heat, and leaving thermoset fibers or mash behind), or by compression or heat molding in a secondary section. Where thebacking 16 is made from sheet metal, the living hinge can be formed by a flat section of said sheet while thebacking 16 and thecompression panel 17 are strengthened by folding up their edges. In some embodiments the flexibility of the livinghinge 18 vs. the rigidity of thebacking 16 and thecompression panel 17 is achieved at least partly due to material treatment such as local heat treatment, selective surface treatment or selective composition variation. In some embodiments theliving hinge section 18 can be formed by an added layer of flexible material interposed between therigid backing 16 and thecompression panel 17 along the designated fold line. In one embodiment this flexible layer is a label. The additional layer can be locally attached along the edge closest to the fold line, or it can cover broader parts or an entire facet of thebacking 16 and/or thecompression panel 17. The added on layer can be pre-printed with the desired graphics or information. In yet other embodiments, the livinghinge section 18 can be made from a resilient material. The resilient material section can be formed by one of the means known in the art including pre-making and attaching between the flaps, co-molding, co-extrusion, insert-molding, etc. In one embodiment a wall of thepackage 9 is substantially rigid to provide the backing. In one embodiment a wall of thepackage 9 is substantially rigid and extends to provide the compression panel. It will be obvious to those skilled in the art that afolding hinge 18 can be formed in other methods such as in the form of a door hinge where an axis runs along the fold line through fixtures (such as bores) in each of the flaps 16&17, or a socket and meniscus arrangement as is common in various plastic products. The backing and the compression panel 16&17 may have any shape and are not limited to the mostly thin-rectangular shape apparent inFIG. 1 - The
fluid transport device 14 comprises a proximal end having a form of a pouch insert fitment commonly used in pouch containers for connecting a cap or a spout to a flexible package. The fitment is sealed in a fluid tight fashion between theflexible wall 11 and the additional wall (not shown) such that, upon activation, the product flowing in thefluid passageway 13 is restricted to flow into the inner passage of thefluid transport device 14. The distal end of thefitment 14 is in a fashion of a Male Luer Slip connector which is commonly used in medical fluidic systems related to drug delivery or fluid management. TheLuer Slip connector 14 can be used as a spout for directly dispensing the product to a target or to communicate with a Female Luer connector of another device or system such as a hypodermic needle hub, a Y-site injection point of an infusion system and so forth. Thus thefluid transport device 14 in a form of a Luer Slip connector creates a range of possible applications for the dispensingpackage 10 of the present disclosure. In one embodiment the device receives a hypodermic needle and functions as a medical syringe. In another embodiment thedevice 10 is a prefilled unit-dose of medication for introduction to an infusion set through a Y-Site. The fluid transport device may include a replaceable closure for resealing the package. In other embodiments the distal end offluid transport device 14 is of different fashion such as a hypodermic needle attached directly to thefitment 14; a connector to a tube, capillary tube or a hose; a Luer Lock connector; a foam or other absorbent pad for topical application to a surface such as the skin; a spray head; a nasal sprayer or dropper; an oral or eye dropper; an irrigation nozzle; a mini needle or needles; a micro-needle or micro-needles array; a jet injector; or an extension/coupling unit to one of the above - Referring now to
FIG. 1 c and its enlarged detail view inFIG. 1 d, thedevice 10 is illustrated at a post activation state, where theoutlet seal 13 has been separated (the Figures shows the frangible section inflated relative toFIGS. 1 a and 1 b) and fluid communication has been established between thecompartment 12 and thefluid transport device 14. It should be understood that the outlet seal has been separated either by: application of force directly to the compartment 12 (for instance by depressing with a thumb); by folding therigid backing 19 and squeezing the product compartment, or by another apparatus that serves this approach. Theoutlet seal 13 is defined as a section produced such that the force required for separating the seal is lower than the force required for separating thepermanent seal 15. U.S. Pat. No. 5,176,634, U.S. Pat. No. 6,203,535, and U.S. Pat. No. 5,131,760 disclose materials, methods and processes for producing selective areas of frangible seal in an otherwise permanent seal package. One concern with frangible seals is that the excess pressure generated for rupturing the frangible seal may cause a burst of the product through thefluid transport device 14 at the instant that thefrangible seal 13 is ruptured. In one embodiment at least part of the fluid path between thecompartment 12 and the outlet of thefluid transport device 14 acts as a flow restrictor either by limiting the cross section of the passage, by extending the length of the flow passage, or by posing features in the flow passage which increase drag and pressure drop. In another embodiment theoutlet seal 13 is made such that the seal strength is gradually or incrementally decreasing along the direction of the flow path. Thus a certain threshold pressure is required to initiate the separation of the frangible seal, while the following front of the separation requires lower pressure to separate and so forth until thefrangible section 13 is completely separated and a flow communication is established between theproduct compartment 12 and thefluid transport device 14, at which point thefluid passageway 13 is wide open and the resistance to the dispensing flow is relatively low. -
FIG. 1 e illustrates the device at a dispensing orientation where thecompression panel 17 is folded over therigid backing 16 such that thecompartment 12 may be squeezed between the two. - In a further embodiment the device incorporates a one-way valve for preventing refill of the
package 9 after its first use. The valve can be incorporated in the fluid transport device, or in the fluid passageway or in the compartment and can be formed or disposed: between the walls of the package; between the package and the backing; or in the backing. - Referring now to
FIG. 19 , a further preferred embodiment is illustrated which does not include a compression panel. Thepackage 9 can be squeezed by direct depression of a thumb or by depressing a separate compression panel. In one embodiment the device is associated with and apparatus that is made to operate the device which includes a compression panel for depressing thepackage 9. The compression panel is not limited to a flat pad that is apparent inFIG. 1 , and can be in other forms known in the art such as a curved panel or a roller. - Referring now to
FIG. 2 , a further preferredembodiment 20 is illustrated which is similar to the embodiment ofFIG. 1 . Here, thefirst compartment 12 contains a first substance, and theflexible package 9 comprises asecond compartment 21, prefilled with a second substance. Prior to activation, the two compartments are hermetically separated by a second frangible seal 13 (hereafter sometimes referred to as the “mixing seal”) which is ruptured at the point of use by pressurizing one or both of thecompartments FIG. 2 a illustrates thedevice 20 in the rest position, prior to activation showing thefirst compartment 12 and thesecond compartment 21 separated by the mixingseal 22.FIG. 2 b shows a broken top view of thedevice 20 revealing in more details the form of theflexible wall 11. The mixing seal pattern resembles like saw teeth which, during activation, cause stress concentration to facilitate the rupture of the mixingseal 22. -
FIG. 2 c shows a broken side view of the pre-activation state of thedevice 20. Theproduct compartment 12 and thesecond compartment 21 have a relatively deep form (i.e deep cavity with small sealing footprint). Fluid pouches or blisters are commonly made relatively shallow, and the unique shape of the current compartments 12&21 are advantageous to reduce the depression surface during activation and dispensing resulting in higher pressure of the substances and a more efficient expression of the product. The deep cavities ofcompartment frangible seal 22 from end to end until the twocompartments -
FIG. 2 d and its enlarged detail view inFIG. 2 e demonstrate thedevice 20 after merging thefirst compartment 12 with thesecond compartment 21 of thepackage 9, at a pre-activation state (i.e., before rupturing the outlet seal). The newmerged compartment 12′ (hereafter still sometimes referred to as “compartment 12” or “product compartment”) has a continuous chamber form which facilitate mixing of the contents of the original package compartments 12&21. In some embodiments the second substance is a dry powder, gel, or paste or a solid which has the tendency to stick in corners and be difficult to dissolve, and the smooth integral shape of themerged compartment 12′ facilitates mixing of the second substance with the first substance. InFIG. 2 e it is apparent that theoutlet seal 13 is in its flattened sealed state prior to activation. The pressure required for separating theoutlet seal 13 is higher than the pressure required for separating the mixingseal 22, thus avoiding a situation where thedevice 20 is activated prior to a complete separation of the mixingseal 22 and the complete mixing of the contents of the twocompartments -
FIG. 2 f and its detail view 2 g illustrates thedevice 20 at a post-activation state, after theproduct compartment 12′ has been further pressurized (pressure higher than that used to cause thecompartments outlet seal 13 has been ruptured. InFIG. 2 g it is apparent that thefluid passageway 13 is inflated after the frangible outlet seal is ruptured. In another embodiment the rupturing force threshold for theoutlet seal 13 is not higher than that of the mixingseal 22. -
FIG. 2 h demonstrates thedevice 20 in a dispensing position where thecompression panel 17 is folded over the backing 16 to squeezeproduct compartment 12′ and cause the product to dispense throughfluid transport device 14. In some embodiments the mixing step, activation step, and dispensing steps which are illustrated above as a sequence of incremental steps, are combined into a single continuously flowing action of folding and depressing thecompression panel 17 over the backing 16 to cause the above sequence. - In another embodiment the dispending package comprises at least one more compartment that is merged with the
first compartment 12 in the same fashion as thesecond compartment 21 does.Embodiment 20 is particularly advantageous where the stability of the finished product can be extended by keeping a certain first substance separated from a second substance of the product until the point of use. In one embodiment the second compartment contains a dry medical substance such as vaccine or antibiotics that need to be reconstituted with a diluent prior to delivery. In other embodiments the second substance is a bio-pharmaceutical in a thick gel form (which extends its shelf life) which needs to be diluted with the first substance in order to be delivered through a thin needle. - Referring now to
FIG. 3 a further preferredembodiment 30 is illustrated where thepackage 9 comprises twofirst compartments 12′ and 12″ which are activated and dispensed in parallel in the same fashion as done with thesingle compartment embodiment 10 ofFIG. 1 . Thefluid passageway 13, which includes at least one outlet seal, interconnects thecompartments 12′and 12″, and directs their content to thefluid transport device 14. It will be obvious to those skilled in the art that each of thecompartments 12′ and 12″ can incorporate companion substance compartments to be merged with thefirst compartments 12′and 12″ to form the product, as illustrated withembodiment 20 inFIG. 2 . Additionally it will be obvious to those skilled in the art that a similar embodiment toembodiment 30 may comprise more than two first compartments in parallel embodied in a single package or multiple packages. In a further embodiment the common section of thefluid passageway 13 tocompartments 12′and 12″ comprises features that facilitates mixing of the products of the twocompartments 12′ and 12″, prior to reaching thefluid transport device 14. In another embodiment the fluid transport device comprises mixing elements for mixing the substances of the product. The mixing element can be at least partially disposed or formed in one or more of: between the walls of thepackage 9; between thepackage 9 andbacking 16; in thebacking 16. - Referring now to
FIG. 4 a a further preferredembodiment 40 is demonstrated where thefluid transport device 41 is a fitting joined to the external side of theflexible wall 11.FIG. 4 b illustrates thedevice 40 in an exploded view. The proximal end of thefitment 41 has a form of a flange for sealing to the surface of thewall 11 around anopening 42 in thefluid passageway 13. The distal end of thefluid transport device 41 has the form of a Luer Slip connector. - Referring now to
FIG. 5 , a further preferredembodiment 50 is demonstrated where thefluid transport device 51 is merely the distal end of thefluid passageway 13 shaped like atip 51.FIG. 5 a demonstrates the arrangement such that thefluid passageway 13 leads to thefold line 18 of thebacking 16 where anopening 52 in thehinge section 18, between the backing 16 and thecompression panel 17, receives the dispensingtip 51 of thefluid passageway 13. Thus thefluid transport device 51 is integrated in thepackage 9.FIG. 5 b illustrates the administration position of thedevice 50. Thecompression panel 17 is folded over the backing 16 such that the merged product compartment (not shown) is squeezed between the two. The dispensingtip 51 shows in theopening 52 allowing a convenient dispensing of the contents to a target when thedevice 50 is folded. The advantage of this arrangement is that it avoids the fitment which is incorporated in some of the embodiments above which adds manufacturing cost and complexity to the manufacturing equipment.FIG. 5 c illustrates an exploded view of thedevice 50 revealing asecond wall 53 which seals with theflexible wall 11 to form thecompartment 12. The dispensingtip 51 can be formed in various shapes to support a specific application including: a) long or short tip, b) wide or narrow outlet, c) single or multiple outlets, d) irrigation, dripping or spraying tip, e) topical applicator or dropper, etc. - Referring now to
FIG. 6 , a further preferredembodiment 60 is illustrated, mostly similar toembodiment 20 ofFIG. 2 , here with theflexible wall 11 covering thebacking 16 and thecompression panel 17 in its entire, as shown inFIG. 6 a. Thecompression panel 17 may be made to coincide with the footprint of the compartment. In addition, as shown in the exploded view inFIG. 6 b, theflexible wall 11 seals directly against the backing 16 to form the package 9 (including theproduct compartment 12, the secondfrangible seal 22, thesecond compartment 21 and the frangible seal 13). Thebacking 16 can be made from a substantially rigid film or foil sheet, and can be printed with information such as graphics or texts. - Referring now to
FIG. 7 a further preferredembodiment 70 is illustrated where the fluid transport device is partially embedded in thebacking 16.FIG. 7 a demonstrates thedevice 70 at a pre-activation position. Thefluid passageway 13 is facing thefold line 18, where anopening 52 between the backing 16 and thecompression panel 17 receives a pointy tip of theflexible package 9. Thefluid passageway 13 ends before saidtip 72 thus slightly chocking the outlet channel and restricting the product flow to thetip 72.FIG. 7 b shows thedevice 70 in the dispensing position. The dispensingtip 72 is emerging through theopening 52 in thefold line 18 allowing for convenient dispensing of the product. -
FIG. 7 c and its detail viewFIG. 7 d illustrate exploded view of thedevice 70. Theflexible wall 11 is sealed to asecond wall 73 to form thepackage 9. A throughhole 74 in thesecond wall 73 is aligned with the distal end of thefluid passageway 13 such that when theoutlet seal 13 is separated, theproduct 9 flows through thefluid passageway 13 and out throughhole 74 in theadditional wall 73. The fluid transport device is agroove 71 in thebacking 16 which is sealed over with theadditional wall 73 to form a closed fluid passageway between thehole 74 and the dispensingtip 72. Thus the fluid passageway is partly interposed between the rigid backing andpackage 9. The dispensing tip is formed between the distal end of thegroove 71 and the edge of theadditional wall 73. The distal end of the groove can be formed in various shapes to generate the desired dispensing pattern including: single nozzle, multi nozzle, long or short nozzle, irrigation nozzle, drops nozzle, spray nozzle, etc. Thus at least a portion of the fluid transport device is partly interposed between the rigid backing and thepackage 9. - Referring now to
FIG. 8 , a further preferredembodiment 80 is illustrated which is mostly similar toembodiment 70 ofFIG. 7 , hereembodiment 80 comprising multiplefirst compartments 12′ and 12″ andadditional compartments 21′ and 21″ in parallel, as is apparent inFIG. 8 a.FIG. 8 b illustrates an exploded view of thedevice 80, exposing theT shape groove 81 which, when sealed on top with thepackage 9, forms a closed fluid passageway between the compartments and the dispensingtip 72. In one embodiment thegroove 81 further comprises features for enhancing the mixture of the flows coming down from the different merged compartments. It will be obvious to those skilled in the art that similar embodiments can include more than two sets of compartments in parallel, embodied in one or more packages. - Referring now to
FIG. 9 , a further preferredembodiment 90 is illustrated. Theembodiment 90 is substantially similar to theabove embodiments 70, here with the fluid transport device being completely embedded in thebacking 16.FIG. 9 a illustrates thedevice 90 in the pre-activation position where the dispensingtip 91 is seen in theopening 52 in thefold line 18. -
FIG. 9 b illustrates thedevice 90 in the dispensing position where thebacking 19 is folded and the dispensingtip 91 emerges from theopening 52 to conveniently dispense the product from the merged compartment. -
FIG. 9 c and its enlarged detail view inFIG. 9 d illustrates an exploded view of thedevice 90. Thehole 74 in thesecond wall 73 is aligned with ahole 91 in thebacking 16 that communicates with aninternal fluid passageway 93 in thebacking 16 that leads to the dispensingtip 91 in a fashion of a dropper. The dispensing tip can be formed in various forms and can receive additional parts to form the desired nozzle form for specific applications such as irrigation, spray, jet, etc. Alternatively, the fluid transport device can merely be an adapter, connector, or extension to a nozzle of the kind mentioned above. Thusembodiment 90 illustrates a fluid transport device that is integrated in thebacking 16, and a fluid passageway that is partially integrated in the backing. - It will be obvious to those skilled in the art that the fluid transport device can be a combination of those shown in
FIGS. 5 , 7 and 9 such that the fluid passage from the product compartment or merged compartment to the dispensing tip passes: a) between theflexible wall 11 and at least one additional wall, b) between theflexible wall 11 and thebacking 16, c) in an internal passage in thebacking 16, and in addition d) through an add on components that communicate with thebacking 16. - Referring now to
FIG. 10 , a further preferredembodiment 100 is illustrated where thedevice 100 is a unit-dose prefilled reconstitution and delivery hypodermic syringe.FIG. 10 illustrates the first side of thedevice 100 which is similar in form and function to that ofembodiment 90 ofFIG. 9 . -
FIG. 10 b illustrates the second side of thedevice 100 in the pre-activation state, showing that the fluid transport device incorporates ahypodermic needle 101 having its proximal end connected to aneedle hub 102. Theneedle hub 102 is accommodated in a fluid tight fashion in an opening in thebacking 16, and receives the product after activation. Arecess 103 in thecompression panel 17 accommodates the distal end of theneedle 101 and provides protection from mechanical damage to it as well as protection from needle sticks to the user. -
FIG. 10 c illustrates a section view of thedevice 100 at the pre-activation stage. Thesecond compartment 21 contains an activemedical ingredient 105 such as dry powder or lyophilized vaccine or medication, and theproduct compartment 12 contains a diluent 104 for reconstituting the dryactive ingredient 105 at the point of use. The communication channel 13 (which in this position is flattened and sealed) leads to avertical channel 106 in thehub 102 which is in fluid communication with theneedle 101, and the arrangement is such that, after activation, fluid from theflexible package 9 can strictly flow to theneedle 101 when the merged compartment is depressed. -
FIG. 10 d illustrates thedevice 100 after thefirst compartment 12 and thesecond compartment 21 of thepackage 9 have been merged 12′ to create the product. -
FIG. 10 e illustrates thedevice 100 after activation where theoutlet seal 13 has been ruptured (shown inflated relative toFIG. 10 d) forming a fluid passageway (13) with theneedle hub 102. -
FIG. 10 f shows the device in the dispensing position where themerged compartment 12′ is squeezed between the backing 16 and thecompression panel 17 expressing the product fromcompartment 12′ through theneedle 101. By folding over thecompression panel 17 over thebacking 16, theneedle 101 is exposed to conveniently apply to a patient. It will be obvious to those skilled in the art that the sequence of incremental steps presented betweenFIGS. 10 c and 10 f can be performed as one continues action by merely folding thecompression panel 17 over thebacking 16. It will also be obvious to those skilled in the art that theneedle 101 can be directly associated to thebacking 16 to eliminate the needle hub. - Referring now to
FIG. 11 , a further preferred embodiment is illustrated which is substantially similar toembodiment 100 ofFIG. 10 , here with the theneedle 101 directly attached to thebacking 16, thereby avoiding the hub (102 inFIG. 10 ). The proximal end of theneedle 111 is bent at a right angle toward thefluid passageway 13. In this embodiment theneedle 101 is attached to thebacking 16 in one of the means know in the art such asglue 112. - Referring now to
FIG. 12 , a further preferred embodiment is illustrated where thedevice 120 comprises an integral sterile cover.FIG. 12 a demonstrates thedevice 120 comprising a peel awaysterile cover 121 applied directly to a recessedsurface 123 of thebacking 16 forming an aseptic zone around the needle, and keeping it sterile and protected until the time of use. In one embodiment thedevice 120 is sterilized in this configuration, without any additional sterile overwrap to theentire device 120, thus thefluid transport device 101 remains sterile until the time of use. In one embodiment theproduct 120 is sterilized by Gamma radiation. In another embodiment thecover 121 is made from a breathable web (such as Tyvec, Dupont) and theproduct 120 is sterilized by ETO. The walls around recessedsurface 123 form a cavity that protectscover 121. Aloose tab 122 facilitates the peeling of thecover 121 prior to use. -
FIG. 12 b illustrates thedevice 120 after thecover 121 has been removed. The livinghinge 18 is located such that it forms a continuous flat surface with the recessedsurface 123, providing a flat surface for attaching thecover 121. Thecover 121 may be removably joined to the recessedsurface 123 by an adhesive layer or by welding, or any other means known in the art. Theneedle 101 is connected to theneedle hub 102 which in return is connected to thebacking 16 in the same fashion as inembodiment 100 ofFIG. 10 . The needle is protected in thegroove 103 in thecompression panel 17 until the later is folded for squeezing thepackage 9. -
FIG. 13 demonstrates a further preferredembodiment 130 which comprises a mechanism for destroying theneedle 101 at the end of the use of theproduct 130.FIG. 13 a demonstrates thedevice 130 at the end of the dispensing stage where thecompression panel 17 is fully rotated in the direction of the arrow until it is in complete contact with backing 16, and the product is completely expelled. The living hinge is located at about the midline of the thickness of thebacking 16 such that it allows thecompression panel 17 to rotate both ways from the flat pre-use position. Theneedle 101 is revealed for conveniently introducing it to a patient. -
FIG. 13 b demonstrates thedevice 130 after thecompression panel 17 has been turned in a reverse direction ofFIG. 13 a, in the direction of the arrow (i.e. approximately 360 degrees around fold line 18) bringing the opposite sides of thecompression panel 17 and thebacking 16 to contact, and disabling thefluid transport device 101 by thecompression panel 17. As the proximal end of theneedle 101 is fixed to thebacking 16, the turning of thecompression panel 17 forces the needle to bend and be destroyed such that thedevice 130 cannot be reused, or the remaining product in the package cannot be abused. In addition in this position theneedle 101 tip is protected from causing needle sticks after the product has been discarded. In one embodiment thedevice 130 comprises a feature that latches thebacking 16 and thecompression panel 17 in the discarded position such that the flaps can not be separated and the needle cannot be accessed once thedevice 130 is folded to this position. - Referring now to
FIG. 14 , a further preferred embodiment is illustrated. Twointegral springs 141 stretching between the backing 16 and thecompression panel 17, and are located in an offset position to thefold line 18, such that the compression panel is biased into on of a first and a second angular position relative to thebacking 16 . In one embodiment, thesprings 141 bias into a first stable position in which thecompression panel 17 lays flat with thebacking 16 and a second stable position in which thecompression panel 17 is folded over the backing 16 in the dispensing position. In another embodiment, the first stable position is when thecompression panel 17 is partly folded over thebacking 16, such that when thedevice 140 is removed from the package and is released from the flat position, thecompression panel 17 will snap to the semi-folded position. -
FIG. 15 illustrates a further preferred embodiment. Here, therigid backing 16 and the compression panel are interconnected byhinge 18. In addition thebacking 16 and thecompression panel 17 are interconnected by pairs of cooperating joints to restrict movement of said pivot section in one pivot direction. Each of the two joints comprises twosegments first segment 151 is connected at one end to thebacking 16 by a flexible hinge, and thesecond segment 152 is connected at its other end to thecompression panel 17 by a flexible hinge, such that when the compression panel is pivoted thecompression panel 17, thebacking 16, thefirst segment 151 and thesecond segment 152 act like a “four bar mechanism”.FIG. 15 a illustrates the device in a flat pre-activation position where thesegments backing 16 and thecompression panel 17.FIG. 15 b illustrates thedevice 150 where thecompression panel 17 is folded to a position where it is partly squeezing the first compartment causing it to merge with the second compartment. The arms are now folded such that thesecond segment 152 prevents thecompression panel 17 from further folding toward thebacking 16, thus preventing an unintentional or uncontrolled compression of thepackage 9, and a burst of the contents of the package when thedevice 150 is activated. In order to dispense the contents of thedevice 150 the joints need to be: a) flipped to the opposite position, or b) the hinges betweensegments - Referring now to
FIG. 16 , a further preferredembodiment 160 is illustrated in which theflexible package 9 is supported by the rigid backing only at the point of use.FIG. 16 a demonstrates thedevice 160 in the pre-activation configuration. Apackage 9 is formed from a firstflexible wall 11′ and a second reciprocalflexible wall 11″ sealed about their perimeters such that they form aproduct compartment 12 and asecond compartment 21 separated by a mixingseal 22. Anoutlet seal 13 separates thesecond compartment 21 and thefluid transport device 14. The proximal end of thefluid transport device 14 is in the form of a pouch insert fitment and is sealed between the twoflexible walls 11′ and 11″. The distal end of thefluid transport device 14 is ahypodermic needle 101, which at the pre-use state is confined between the backing 16 and thecompression panel 17 which serve as a needle protector. Thefluid transport device 14 further comprises a laterally extendingplatform 162 to which thefirst flap 16 and thesecond flap 17 are joined via aliving hinge 18, such that each of thebacking 16 and thecompression panel 17 can pivot in opposite directions about 180 degrees toward thepackage 9. Each of thehacking 16 andcompression panel 17 further comprises acantilever spring section 163 which extends from the distal edge of thebacking 16 andcompression panel 17 toward their proximal end. -
FIG. 16 b illustrates an intermediate position during the turning of backing 16 andcompression panel 17. Thebacking 16 andcompression panel 17 are pivoted around theirhinges 18 toward thepackage 9, thereby exposing theneedle 101. -
FIG. 16 c illustrates thedevice 160 after thebacking 16 andcompression panel 17 have been completely folded back such that their distal ends are touching each other. At this position thebacking 16 is supporting thepackage 9 and thecompression panel 17 is partly squeezing thepackage 9 against thecompression panel 16 causing theproduct compartment 12 to merge with thesecond compartment 21 and theoutlet seal 13 to separate and establish fluid communication with thefluid transport device 14. The arrangement is such that an only insignificant portion of the contents of themerged compartment 12′ may expel at this position through thefluid transport device 14. In one embodiment the rotation of thebacking 16 andcompression panel 17 to this position does not separate the frangible seal and fluid communication is not being established between themerged compartment 12′ and the fluid transport device. In one embodiment the rotation of thebacking 16 andcompression panel 17 to this position causes theoutlet seal 13 to only partly separate such that fluid communication is not being established between themerged compartment 12′ and the fluid transport device. In a further embodiment theoutlet seal 13 is made such that the seal force is gradually lowering toward thefluid transport device 14, and thefrangible seal 13 is partly separated such that fluid communication is not being established between themerged compartment 12′ and the fluid transport device, but the force for separating the remaining part of theoutlet seal 13 is lower than the force that was required for separating the initial portion of thefrangible seal 13. -
FIG. 16 d illustrates thedevice 160 at the dispensing stage. The fingers of the user are repositioned to press on thecantilevers 163 causing thecantilevers 163 to deflect and further squeeze themerged compartment 12′ thereby causing the contents to expel until thebacking 16 andcompression panel 17 contact one another and the merged compartment is emptied. In one embodiment the cantilever springs 163 are connected in at least one additional location beside the joint 18, through a rupturable bridge which will: a) provide initial resistance to avoid unintentional squeezing of themerged compartment 12′, and b) serve as evidence that thedevice 160 has not been tampered with. - The
device 160 provides a mechanism for avoiding unintentional dispensing (or bursting) by dividing the operation of thedevice 160 into two main stages (i.e. activation and dispensing) which requires finger repositioning between said two stages. - Referring now to
FIG. 17 , a further preferredembodiment 170 is illustrated which comprises a flow regulator in the dispensing passage to avoid a burst of the contents when thedevice 170 is activated.FIG. 17 a illustrates a general view of the first side of the device, showing apackage 9 similar toembodiment 100 ofFIG. 10 , here the arrangement of thepackage 11 is turned in the opposite direction such that thefluid passageway 13 is facing away from thefold line 18. -
FIG. 17 b and its enlarged detail inFIG. 17 c illustrate an exploded view of thedevice 170 showing anembossed channel 170 in the surface of thefirst flap 16, which when sealed over with thesecond wall 74 of thecompartment 12 forms a closed fluid passage that serves as a dynamic flow regulator. Areceptacle section 175 at the distal left end of thechannel 171 communicates with thefluid passageway 13 in thepackage 9 and receives the fluid expelling from thepackage 9 when saidpackage 9 is squeezed. Alabyrinth portion 172 of thechannel 171 communicates between thereceptacle 175 and the regulatingstraight section 173 of thechannel 171. The proximal end of the channel (right side in this figure) comprises an opening for accommodating theneedle hub 102 such that flow entering thechannel 171 will proceed through thechannel 171 and into theneedle 101. The purpose of thelabyrinth 172 is to cause pressure dampening which increases with the increase in the flow rate. -
FIG. 17 d illustrates a broken section view along theflow channel 171 of thedevice 170 showing the device immediately after activation. Thedevice 170 is already activated and a relatively high pressure is generated in themerged compartment 12′. This situation may occur at the instant after thedevice 170 was activated when the fingers of the user still exert relatively high force on thebacking 16 andcompression panel 17, which was required to rupture thefrangible seal 13. Referring back toFIG. 17 d, under the high pressure condition, the flow advances from themerged compartment 12′ throughreceptacle 175 and intolabyrinth 172 where it loses substantial pressure such that the flow received in the regulatingstretch 173 is substantially lower than the pressure in themerged compartment 12′. As a result of the pressure difference between the fluid in themerged compartment 12′ and the flow in the regulatingstretch 173, the package is distorted such that the section of theadditional wall 73 is stretching down into the regulating straight 173 and the cross section of the regulating straight 173 is reduced. The distortion of the package reduces the flow rate of the expelling fluid, thereby preventing bursting of the dispensable fluid through thefluid transport device 14. -
FIG. 17 e illustrates thedevice 170 in the administration phase. As the force exerted by the fingers is adjusted (from activation state to administration state), and the pressure in themerged compartment 12 is lowered, the pressure difference between themerged compartment 12 and the regulating straight 173 is lowered, causing theadditional wall 74 to retract and reduce the flow restriction in the regulatingchannel 171. The advantage of this embodiment is that an efficient means for avoiding burst of fluid contents during activation is achieved without significantly affecting the resistance to flow during the administration of the contents to a patient. It will be obvious to those skilled in the art that thelabyrinth section 172 can be eliminated as long as sufficient pressure difference between thepackage 9 and the regulating straight 173 is developed to effectively manipulate thesecond wall 74 to warp into theflow path 171. In another embodiment a piece of elastomer is accommodated in the flow channel. The elastomeric piece comprises a flow channel embossed in it, and the arrangement is such that theadditional wall 73 presses on the elastomeric piece to regulate the cross-section of the channel in the elastomeric piece, thereby regulating the flow. It will be obvious to those skilled in the art that other arrangements for dynamically regulating the flow utilizing the pressure in the merged compartment exist and the one provided in this embodiment is by way of example only. - In further embodiments the device comprises a one way valve for avoiding refilling of the product compartment after completion of the intended first use. In further embodiments the device comprises a time indicator which indicates a period of time elapsed since activation. The device may further include child protection such that it will be challenging to operate the device by a child, thereby avoiding accidental dispensing or needle sticks.
- Referring now to
FIG. 18 a further preferredembodiment 180 is illustrated. Thebacking 16 now has asecond fold line 181 which is located directly under theproduct compartment 12, and defining asecond compression panel 182 within thebacking 16. Thepackage 9 is supported by thebacking 16 and saidsecond compression panel 182. The arrangement is such that theflap 182 can only be manipulated to pivot toward the first compartment 12 (and not from the flat position away from the product compartment 12), thereby causing thefirst compartment 12 to pressurize. In one embodiment the folding of thesecond compression panel 182 serves to squeeze thefirst compartment 12, causing it to merge with thesecond compartment 21 and/or with additional compartments. In another embodiment the folding of thethird flap 182 serves to squeeze thefirst compartment 12 and thereby rupture thefrangible seal 13 and establish fluid communication with thefluid transport device 14. In another embodiment thefirst compression panel 17 is eliminated and thesecond compression panel 182 serves for dispensing the product.FIG. 18 a illustrates thedevice 180 at a pre-activation position. Theshoulder 183 in thebacking 19 and theflap 182 prevent theflap 182 from pivoting downwardly and away from the product compartment.FIG. 18 b illustrates thedevice 180 after theflap 182 is rotated and thefirst compartment 12 has merged with thesecond compartment 21. - Accordingly, the present disclosure has been described with some degree of particularity directed to the exemplary embodiments thereof. It should be appreciated, though, that the present disclosure is defined by the following claims construed in light of the prior art so that modifications or changes may be made to the exemplary embodiments of the present disclosure without departing from the inventive concepts contained herein.
Claims (26)
1. A dispensing device, comprising:
a package comprising at least a first compartment having a flexible wall portion;
a fluid transport device; and
a backing associated with said package which, during dispensing, supports the package to facilitate expression of a product from the package through said fluid transport device.
2. A dispensing device according to claim 1 wherein said fluid transport device is hermetically separated from said product prior to activation and adapted, upon activation, to be placed in fluid communication with said product via a rupturable fluid passageway.
3. A dispensing device according to claim 1 where said flexible wall portion is permanently sealed along a first peripheral margin of said first compartment and non-permanently sealed along a second peripheral margin of said first compartment to define at least a first frangible outlet seal located between said first compartment and said fluid transport device such that, when said first frangible seal is ruptured, a fluid communication is established between said package and said fluid transport device.
4. A dispensing device according to claim 1 further comprising a compression panel for compressing at least a portion of said package relative to said backing.
5. A dispensing device according to claim 4 wherein said compression panel is moveably joined to the backing.
6. A dispensing device according to claim 4 wherein at least one of said backing and said compression panel is configured to coincide with a footprint of said at least a first compartment.
7. A dispensing device according to claim 1 further comprising at least a second compartment hermetically separated from said first compartment by a frangible mixing seal.
8. A dispensing device according to claim 1 wherein at least a portion of said fluid transport device is joined with said package through a fitment.
9. A dispensing device according to claim 2 having at least one of a plurality packages, a plurality of compartments, a plurality of passageways, a plurality of fluid transport devices, and a plurality of frangible seals.
10. A dispensing device according to claim 7 wherein a passageway interconnects said first and second compartments with said fluid transport device.
11. A dispensing device according to claim 1 wherein at least one of said fluid passageway and said fluid transport device is at least partially interposed between said rigid backing and said package, is formed partly in the rigid backing, is at least partially interposed between said flexible wall portion and a second wall of said package, or is at least partially integrated in at least one of said package and said backing.
12. A dispensing device according to claim 1 further comprising a plurality of compartments and at least one mixing seal disposed therebetween.
13. A dispensing device according to claim 1 wherein said package is formed from and comprises a plurality of walls.
14. A dispensing device according to claim 1 where in said backing defines a wall of said at least a first compartment.
15. A dispensing device according to claim 1 further comprising a flow control device at least partially disposed between the walls of the package, between the package and the backing or in the backing.
16. A dispensing device according to claim 1 further comprising a flow regulator at least partially formed between the backing and the package wherein product pressure in the package distorts the package to restrict flow through the fluid passageway.
17. A dispensing device according to claim 16 wherein said flow regulator is an embossed channel having a labyrinth portion.
18. A dispensing device according to claim 1 where said fluid transport device is selected from a group consisting of at least one of a needle, a mini-needle, a micro-needle, a connector, a fitting, a tube, a dropper, a topical applicator, a spray head, and a jet injector.
19. A dispensing device according to claim 4 where said package is at least partially supported by the compression panel.
20. A dispensing device according to claim 4 where said compression panel protects at least a portion of said fluid transport device prior to use.
21. A dispensing device according to claim 1 further comprising a cover removably joined to said backing to hermetically seal at least a portion of the fluid transport device.
22. A dispensing device according to claim 1 comprising a resealable said package.
23. A dispensing device according to claim 1 where said fluid transport device is disabled after use.
24. A dispensing device according to claim 4 where said compression panel disables said fluid transport device after use.
25. A method comprising:
(a) providing a device comprising:
a package comprising at least a first compartment containing a product,
said first compartment having a flexible wall portion;
a fluid transport device; and
a backing; and
(b) compressing said package against said backing to dispense said product through said fluid transport device.
26. A method according to claim 25 wherein said device further comprises a compression panel for accomplishing (b), said method further comprising disabling said fluid transport device with said compression panel.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US13/393,490 US20120241465A1 (en) | 2009-08-30 | 2010-08-30 | Dispensing device along with method for dispensing product |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US23818109P | 2009-08-30 | 2009-08-30 | |
US61238181 | 2009-08-30 | ||
PCT/US2010/047189 WO2011026050A2 (en) | 2009-08-30 | 2010-08-30 | Dispensing device along with method for dispensing product |
US13/393,490 US20120241465A1 (en) | 2009-08-30 | 2010-08-30 | Dispensing device along with method for dispensing product |
Publications (1)
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US20120241465A1 true US20120241465A1 (en) | 2012-09-27 |
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ID=43628695
Family Applications (1)
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US13/393,490 Abandoned US20120241465A1 (en) | 2009-08-30 | 2010-08-30 | Dispensing device along with method for dispensing product |
Country Status (8)
Country | Link |
---|---|
US (1) | US20120241465A1 (en) |
EP (1) | EP2470444A4 (en) |
JP (1) | JP2013503019A (en) |
CN (1) | CN102712408A (en) |
AU (1) | AU2010286440A1 (en) |
BR (1) | BR112012004439A2 (en) |
RU (1) | RU2012112219A (en) |
WO (1) | WO2011026050A2 (en) |
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US20120223099A1 (en) * | 2011-03-03 | 2012-09-06 | Roy Sanchez | Fold and Squeeze Condiment Packet Sauce Wrapper |
US20140008366A1 (en) * | 2011-01-17 | 2014-01-09 | Aktivpak, Inc. | Aseptic cartridge and dispenser arrangement |
US8662349B2 (en) * | 2009-08-30 | 2014-03-04 | Aktivpak, Inc. | Dispensing device incorporating frangible section, along with dispensing method |
US20190166974A1 (en) * | 2017-12-05 | 2019-06-06 | Mark Davidov | Disposable Portable Pocket Fluid/Floss Dispenser |
US10369288B2 (en) * | 2015-03-15 | 2019-08-06 | Norimoto Okabe | Sealing container |
US20200037728A1 (en) * | 2018-08-01 | 2020-02-06 | Mark Davidov | Disposable portable pocket fluid/floss dispenser |
US20200062465A1 (en) * | 2018-08-21 | 2020-02-27 | Illinois Tool Works Inc. | Fold and seal flexible valves |
US10918467B2 (en) | 2016-12-09 | 2021-02-16 | Mark Davidov | Disposable portable pocket fluid and floss dispenser |
US11122940B1 (en) * | 2020-07-17 | 2021-09-21 | George Joseph Winn | Wrist-worn sanitizer dispenser |
US20210347536A1 (en) * | 2020-05-05 | 2021-11-11 | Illinois Tool Works Inc. | Flexible package assembly and method of manufacturing |
US20210353016A1 (en) * | 2020-05-15 | 2021-11-18 | Ready Squirt | Wrist dispenser |
US11284697B2 (en) * | 2017-06-23 | 2022-03-29 | Laboratoires M&L | Disposable deformable capsule |
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JP6218747B2 (en) * | 2011-12-16 | 2017-10-25 | インドシス リミテッド | Drug unit dose cartridge and delivery device |
JP2013165757A (en) * | 2012-02-14 | 2013-08-29 | Icomes Labo:Kk | Transfusion device |
US10039884B2 (en) | 2012-06-26 | 2018-08-07 | Becton, Dickinson And Company | Clip syringe |
US20160074586A1 (en) * | 2013-05-02 | 2016-03-17 | Injector Aps | An injection device |
ITMI20131008A1 (en) * | 2013-06-18 | 2014-12-19 | Altergon Sa | SINGLE-DOSE SPRAY DEVICE FOR TOPICAL AND SYSTEMIC APPLICATIONS |
US20160175544A1 (en) * | 2014-12-18 | 2016-06-23 | Marc Andrew Koska | Single use injection system |
AU2016286518A1 (en) * | 2015-07-02 | 2018-02-22 | Marc Andrew Koska | Single use delivery device having safety features |
AU2016286519A1 (en) * | 2015-07-02 | 2018-02-22 | Marc Andrew Koska | Single use delivery device |
CA2991221A1 (en) | 2015-07-02 | 2017-01-05 | Marc Andrew Koska | Single use delivery device prefilled with a reconstitutable agent |
WO2017187262A1 (en) | 2016-04-25 | 2017-11-02 | Marc Andrew Koska | Medical delivery system |
EP3710086A4 (en) | 2017-11-17 | 2021-11-17 | Koska Family Limited | Systems and methods for fluid delivery manifolds |
FR3085842B1 (en) * | 2018-09-14 | 2021-01-08 | Laboratoires M&L | SINGLE-USE DEFORMABLE CAPSULE CONTAINING A COSMETIC PRODUCT |
IT201800009134A1 (en) * | 2018-10-03 | 2020-04-03 | Orofino Pharmaceuticals Group Srl | Syringe for the injection of an injectable solution contained in a deformable cartridge |
USD992110S1 (en) | 2021-08-10 | 2023-07-11 | Koska Family Limited | Sealed fluid container |
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Also Published As
Publication number | Publication date |
---|---|
EP2470444A4 (en) | 2013-03-27 |
AU2010286440A1 (en) | 2012-04-19 |
CN102712408A (en) | 2012-10-03 |
RU2012112219A (en) | 2013-10-10 |
BR112012004439A2 (en) | 2016-03-22 |
JP2013503019A (en) | 2013-01-31 |
WO2011026050A3 (en) | 2011-07-28 |
EP2470444A2 (en) | 2012-07-04 |
WO2011026050A2 (en) | 2011-03-03 |
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