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WO2024115701A1 - Soupape à voie de dérivation et procédé de remplissage correspondant - Google Patents

Soupape à voie de dérivation et procédé de remplissage correspondant Download PDF

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Publication number
WO2024115701A1
WO2024115701A1 PCT/EP2023/083829 EP2023083829W WO2024115701A1 WO 2024115701 A1 WO2024115701 A1 WO 2024115701A1 EP 2023083829 W EP2023083829 W EP 2023083829W WO 2024115701 A1 WO2024115701 A1 WO 2024115701A1
Authority
WO
WIPO (PCT)
Prior art keywords
valve
vessel
pressure
fluid
metering chamber
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/EP2023/083829
Other languages
English (en)
Inventor
Barry FRANKS
Björn O. SÖRENSEN
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Aurena Laboratories Holding AB
Original Assignee
Aurena Laboratories Holding AB
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Aurena Laboratories Holding AB filed Critical Aurena Laboratories Holding AB
Priority to EP23817393.4A priority Critical patent/EP4626616A1/fr
Publication of WO2024115701A1 publication Critical patent/WO2024115701A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05B—SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
    • B05B12/00—Arrangements for controlling delivery; Arrangements for controlling the spray area
    • B05B12/08—Arrangements for controlling delivery; Arrangements for controlling the spray area responsive to condition of liquid or other fluent material to be discharged, of ambient medium or of target ; responsive to condition of spray devices or of supply means, e.g. pipes, pumps or their drive means
    • B05B12/085—Arrangements for controlling delivery; Arrangements for controlling the spray area responsive to condition of liquid or other fluent material to be discharged, of ambient medium or of target ; responsive to condition of spray devices or of supply means, e.g. pipes, pumps or their drive means responsive to flow or pressure of liquid or other fluent material to be discharged
    • B05B12/087—Flow or presssure regulators, i.e. non-electric unitary devices comprising a sensing element, e.g. a piston or a membrane, and a controlling element, e.g. a valve
    • B05B12/088—Flow or presssure regulators, i.e. non-electric unitary devices comprising a sensing element, e.g. a piston or a membrane, and a controlling element, e.g. a valve the sensing element being a flexible member, e.g. membrane, diaphragm, bellows
    • 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
    • B65D83/14—Containers for dispensing liquid or semi-liquid contents by internal gaseous pressure, i.e. aerosol containers comprising propellant
    • B65D83/42—Filling or charging means
    • B65D83/425—Delivery valves permitting filling or charging
    • 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
    • B65D83/14—Containers for dispensing liquid or semi-liquid contents by internal gaseous pressure, i.e. aerosol containers comprising propellant
    • B65D83/44—Valves specially adapted for the discharge of contents; Regulating devices
    • B65D83/52—Metering valves; Metering devices
    • 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
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/02—Sprayers or atomisers specially adapted for therapeutic purposes operated by air or other gas pressure applied to the liquid or other product to be sprayed or atomised
    • 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
    • A61M15/00—Inhalators

Definitions

  • the present invention relates generally to valves assemblies, in particular valve assemblies for spray devices intended to dispense a measured volume of a product concentrate.
  • Such spray devices include spray devices which are intended to provide a metered dose of a product to the mouth of a user.
  • Such oral spray devices include those commonly known as metered dose spray devices (MDIs), which are intended to produce an aerosol of fine particles or droplets for inhalation through the mouth of the user for subsequent deposition in the pulmonary tract.
  • MDIs metered dose spray devices
  • the invention also relates to bag on valve (BoV) spray devices which provide metered doses of a product concentrate to a user in the field of nasal sprays, skin care sprays and the like.
  • BoV bag on valve
  • the pMDI system comprises an aerosol vessel which contains the aerosol formulation which has two components -the product concentrate and the propellant.
  • the aerosol vessel is a disposable container which comprises a, usually crimped-on, valve. Filing of the vessel with the product concentrate and propellant takes place though the valve in pMDI systems. In current BOV systems the bag is attached to the valve and then placed inside the vessel, initially with a gap maintained between the valve and the vessel opening. Compressed gas is injected through this gap until it reaches a first elevated pressure and then valve is crimped onto the vessel. The filing of the bag with the product concentrate can subsequently take place by reverse flow through the valve and metering chamber - this causes the bag to expand and increases the pressure in the vessel to a higher elevated pressure.
  • the product concentrate comprises the active ingredient(s)of the aerosol such one or more pharmaceutical preparations, combined as necessary with any additives such as antioxidants, surfactants, and solvents which are required to prepare a stable and effective product concentrate.
  • the propellant can be one of two types: i) a liquefied gas or a mixture of liquefied propellant gasses that may serve a dual role as both the propellant and the solvent or vehicle for the product concentrate, or ii) compressed gas propellants.
  • Actuation of an actuator moves a valve stem into the metering chamber which causes an opening in the valve stem to communicate with the metering chamber where a pre-metered dose of the product concentrate and propellant in pMDI systems is
  • CFCs chlorofluorocarbons
  • dichlorodifluoromethane dichlorotetrafluoroethane
  • trichloromonofluoromethane chlorofluorocarbons
  • Compressed gas propellants include nitrogen, nitrous oxide and carbon dioxide.
  • the product concentrate When used in a bag- on-valve system the product concentrate is contained in a flexible bag which is connected to the inlet of the metering chamber and valve assembly, and the propellant is provided in the space between the walls of the aerosol vessel and the bag. The propellant exerts a pressure on the flexible bag.
  • the valve When the valve is activated by the user, for example by pressing an actuator connected to the valve stem, then, in a manner similar to that described above with respect to the pMDI, a valve stem is moved to a position which allows dispensing of the contents of the metering chamber while preventing refilling of the metering chamber until the valve actuator is released.
  • a problem with liquified propellant gases is that these gasses are environmentally unfriendly and the use of them is being curtailed or banned. In the future it will not be permitted to use them as propellants which are released to the atmosphere. Thus, it will become necessary to use an environmentally friendly propellant which, of course, is also not harmful to a user in pMDI systems, for example a compressed gas.
  • a problem with compressed gas propellants, which are often used in BoV systems, is that the delivery pressure falls as the spray device is used. As the dispersion pattern and size of the droplets generated during actuation is dependent on the delivery pressure of the propellant, the spray devices become unable to deliver the required droplet pattern and size if the delivery pressure falls too much. This means that the device may stop working before all the product concentrate has been used up. This is wasteful and costly.
  • US9364620B2 teaches a device for providing medication nasally which uses a removable gas cylinder with high pressure gas, two pressure regulators and a refillable medication supply. It requires two regulators to reduce the high pressure in the gas cylinder and to prevent the loss of control of the dispensing pressure which would occur in a single stage regulator if the supply pressure in the gas cylinder became too low. It is complicated and expensive to construct. Furthermore, the valve system is large and is provided as a separate unit to which a separate supply of medication and a sperate prefilled gas cylinder can be attached. This is not suitable for use with handheld spray devices which provide the medication orally.
  • valve system which provides the required delivery pressure for a large number of actuations while avoiding the use of environmentally harmful propellants.
  • a valve system may be applicable both to pressured metered dose spray devices and bag on valve systems using compressed gases.
  • a valve assembly for a handheld spray device for dispensing a product concentrate preferably should be: i) compact in size so that it is compatible with the dimensions of contemporary filling machines and contemporary spray devices and spray device actuating mechanism, ii) attachable to a compressed gas vessel, iii) able to allow filling of a gas vessel with pressurised gas and, if appropriate, active substances via the valve assembly after the valve assembly has been attached to a compressed gas vessel; iv) suitable for use with pressurised gas propellants to give a substantially constant delivery pressure during the required dispensing life of the vessel to which it is attached, v) inexpensive to manufacture.
  • valve assembly has the features of claim 1.
  • a vessel and valve assembly have the features of claim 6.
  • a method for filling such a vessel and valve assembly has the features of claim 9.
  • Figure 1 is a schematic cross-section illustrating the components of a prior art pMDI spray device.
  • Figure 2 is a schematic cross-section illustrating the components of a prior art BoV spray device.
  • Figures 3a) and 3b) illustrate schematically cross-sections of a metering valve in the open and closed positions.
  • Figure 4 is a schematic perspective view of a valve assembly in accordance with a first embodiment of the invention.
  • Figure 5 is a schematic view of the valve assembly of figure 4 after it has been crimped to the neck of a vessel.
  • Figure 6a) show schematically a cross-section though the valve assembly of figure 5 with the valve stem in a dispensing or filling position.
  • Fig 6b) shows schematically in perspective the valve stem from the valve assembly of figure 6.
  • Figure 7 shows schematically the cross-section though the valve assembly of figure 6A with the valve stem in the metering chamber filling position.
  • Figure 8a shows schematically a cross-section of a second embodiment of the invention with the valve stem in a dispensing or filling position.
  • Figure 8b shows schematically in perspective the valve stem from the valve assembly of figure 8a).
  • Figure 9 show schematically a cross-section though a third embodiment of the invention, for use with a bag on valve system, with the valve stem in a dispensing or filling position.
  • Figure 10 schematically illustrates a cross section through the valve assembly of figure 9 with the valve stem in the metering chamber filling position.
  • Figure 11 show schematically a cross-section though a fourth embodiment of the invention, for use with a bag on valve system, with the valve stem in a dispensing or filling position.
  • Figure 12 schematically illustrates a cross section through the valve assembly of figure 11 with the valve stem in the metering chamber filling position.
  • Figure 13 illustrates the steps in a method for filing a vessel provided with a valve in accordance with the present invention.
  • Figure 14a) to 14 c) show schematically in perspective and in cross-section a further embodiment of a BoV valve assembly according to the invention.
  • Figure 15a) to 15 c) show schematically in perspective and in cross-section a further embodiment of a pMDI valve assembly according to the invention.
  • the present disclosure relates generally to devices, systems and methods for dispensing valves and dispensing valve assemblies, in particular metered dispensing valves and assemblies using such valves for spray devices.
  • a valve stem is said to be open when it is placed in a position in which it provides fluid communication between the interior of the metering chamber and the surroundings - this can occur when the valve stem is depressed to allow dispensing from a metering chamber or to allow filing into a metering chamber.
  • the valve stem is said to be closed when it prevents the passage of fluid from the metering chamber to atmosphere.
  • FIG. 1 schematically illustrates across-section through a prior art PMDI valve in a spray device 100.
  • This comprises a metering valve 101 crimped onto a substantially rigid vessel 103 containing the product 105 in solution or suspension in a propellant 107.
  • the product is kept under pressure by the vapourised gas phase 109 of the propellant which is formed from the liquid phase 111 of the propellant in the vessel.
  • an actuator 113 is moved upwards a valve stemll5 is opened to dispense fluid from the metering chamber 117, while at the same time the valve stem moves to a sealing position which prevents more of the liquid phase propellant and product from entering the metering chamber 117 via an opening 119.
  • the fluid in the form of pressurised propellant and product in the metering chamber leaves the metering chamber and enters the expansion chamber 121 where they are subsequently dispensed as a high velocity spray 123.
  • FIG. 2 schematically illustrates a prior art bag on valve (BOV) valve assembly on a vessel 203.
  • This comprises a metering valve 201 and a flexible bag 221 containing the product 205.
  • the product is kept under pressure by pressurized gas propellant 223 contained between the bag 221 and the inner wall 223 of the vessel 203.
  • the product is dispensed by pressing the head 225.
  • BOV bag on valve
  • Figures 3a) and 3b) illustrate the principles of one type of prior art metering valve 301.
  • the inlet openings 329 in the valve stem 331 are not inside the metering chamber 315 (thereby preventing the contents of the metering chamber from being in communication with the nozzle 317) and the inlet valve 333 between the metering chamber 315 and the interior 335 of the pressurized vessel 303 is open (thereby allowing the metering chamber 315 to be filled with pressurized propellant and product from inside the vessel 303).
  • the inlet valve 333 between the vessel 309 and metering chamber 315 has been closed by the movement of the metering chamber towards the vessel, hereby preventing any flow between the interior 335 of the vessel 309 and the metering chamber 315.
  • the actuator is released, the valve stem returns to the closed position shown in figure 3a), blocking fluid communication of the metering chamber to atmosphere but allowing flow from the interior of the vessel to the metering chamber until the pressure in the metering chamber and the vessel are equal, thereby refilling the metering with a measured dose of pressurised product.
  • Figure 4 is a schematic perspective view of a first embodiment of a valve assembly 400 in accordance with the present invention before it is attached to a vessel.
  • the valve assembly comprises a valve body 402 which is sealingly attached to a surrounding conventional crimping cap 404 which can be crimped in the conventional manner onto the neck of a vessel (not shown) which will contain the propellant and product.
  • Figure 5 is a schematic view of the valve assembly of figure 4 after it has been crimped to the neck 406 of a vessel 407 (only partly shown by dashed lines).
  • Figure 6a is a schematic cross-sectional view through the centreline of the valve assembly 400 of figure 4.
  • the valve assembly comprises a valve body 402 which is hollow and cylindrical and has a first end 408 and a second end 418.
  • the first end 408, which is visible during use, is covered by an end cap 410 which has an opening 412 to receive a valve stem 414.
  • the opening 412 is sealed by a valve body to atmosphere seal 416 which allows the valve stem to slide in and out of the opening 412 without any leakage between the valve stem and the opening.
  • the opposite, second end 418 of the valve body is intended to be attached to, or inside, the neck 417 of a, preferably rigid, vessel 419 such as a canister, bottle or bag or the like (shown partly by dashed lines) which encloses the product that is to be dispensed.
  • the valve assembly is sealingly attached to the neck 417 of the vessel and has an opening 420 to allow the passage of the product from the vessel to the interior of the valve body.
  • the valve body is divided into a metering chamber 422 and a pressure regulating portion 424 by an interior partition wall 426 which prevents uncontrolled fluid flow from the pressure regulating portion to, helps to define the volume of, the metering chamber.
  • the partition wall extends across the interior of the valve body, preferably perpendicular to the longitudinal centreline axis A of the valve body.
  • the metering chamber has a metering volume (Vm) which is the free volume available for the dose being.
  • Vm metering volume
  • the metering volume Vm is typically between 0.025 ml to 1.0 ml.
  • the metering volume is equal to or greater than 0.05 ml and equal to or less than 0.25 ml.
  • the pressure regulating portion 424 comprises a pressure regulating valve 462.
  • the pressure comprises a high-pressure inlet 464 which is in fluid communication with the pressurised gas and product containing vessel 419 and a regulated pressure outlet 466 which is in sealable fluid communication with the metering chamber.
  • the partition wall 426 comprising at least one closable fluid dispensing through hole 428.
  • the partition wall comprises one or a plurality of fluid dispensing through holes 428 which, when unobstructed, allow fluid communication between the pressure regulating portion and the metering chamber.
  • the pressure regulating valve comprises an inlet chamber 468 in fluid communication with high-pressure inlet 464 and a regulated pressure outlet chamber 470 in fluid communication with fluid dispensing through hole 428.
  • the inlet and outlet chamber are separated by an intermediate chamber wall 472 with a through hole 474.
  • the through hole 474 has a valve surface 476 facing the interior of the high- pressure chamber.
  • the through hole accommodates a poppet valve 478 which has a poppet valve stem 480 which extends through the through hole 474 and has a valve head 482 in the high-pressure inlet chamber which is adapted to seal against the valve surface 476.
  • the opposite actuating end 484 of the poppet valve stem is in the outlet chamber and is joined to or in contact with a pressure regulating diaphragm or surface 486 which extends across the outlet chamber and separates it from a pressure regulating chamber unit 488.
  • the pressure regulating chamber comprises poppet valve biasing means 490 which bias the poppet valve in the direction towards the high-pressure inlet chamber.
  • the biasing means 490 push the poppet valve open with a force which corresponds to the desired metering valve chamber pressure.
  • the biasing means can be any appropriates force producing means. It could be in the form of a compression spring, for example a helical spring or a Belleville spring or resilient material, force-producing arms acting on the diaphragm or surface 486, or the pressure regulating chamber could be a sealed chamber containing a gas which generates a force which gives the desired biasing force.
  • the diaphragm could itself be shaped to produce the desired biasing force, for example by being concave towards the poppet valve.
  • the biasing means could be formed by a block of rubber-like, gel or sponge-like resilient material which is deformable when pushed on by the poppet valve and resists movement of the actuating end of the poppet valve when the poppet valve is pushed towards it.
  • the amount of resistance can be changed by, for example, changing the surface area of the contact surface of the actuating end of the poppet valve which is in contact with the resilient material.
  • the high-pressure fluid i.e. propellant gas and product concentrate
  • the low-pressure fluid i.e. propellant gas and product concentrate
  • the poppet valve moves towards the valve seat until it reaches the closed position thereby preventing more high- pressure fluid from entering the outlet chamber.
  • the valve stem 414 has a longitudinal bore 432 which extends from a first end 434 of the valve stem which extends outside of the valve body and a second end 436 of the valve stem which is in fluid connection with the interior of the vessel which contains the product which is to be dispensed.
  • the valve stem has a transverse bore 438 which leads from outer surface 440 of the valve stem to the longitudinal bore 432.
  • the valve stem can be moved longitudinally between a closed position in which the fluid dispensing through holes are obstructed, thereby preventing pressurised fluid flow into the metering chamber and an open position in which the through holes are not obstructed and allow the passage of pressurised fluid into the metering chamber from the pressure regulating portion.
  • the fluid dispensing through holes may be obstructed and sealed by a radial enlargement 444 of the valve stem 414 with an appropriate number of corresponding sealing projections 446 which, when brought near to or into contact with the partition wall, project into, and sealingly contact the wall(s) 448 of the through hole(s), thereby sealing the through hole(s) 428.
  • the tips of the sealing projections could be made of a resilient material such as rubber or silicon or the like to ensure good sealing.
  • the transverse bore 438 is positioned so that when the valve stem is in the open position (which is the resting position where dispensing of the product does not take place) the transverse bore is not in fluid communication with the metering chamber, thereby preventing fluid from exiting the metering chamber via the valve stem, and when the valve stem is in the closed position (which is the active position where dispensing of the product can take place) the transverse bore is fluid communication with metering chamber, thereby allowing the contents of the metering chamber to exit to atmosphere via central bore and the open first end of the valve stem.
  • the peripheral surface 450 of the radial enlargement of the valve stem is not in sealing contact with the metering chamber wall and/or has appropriately placed through holes (not shown) which allow fluid flow through it or past it.
  • the pressure regulating portion comprises a pressure regulating valve 462 which is adapted to reduce the pressure of any fluid passing though it from the vessel to the metering chamber to the pressure needed to dispense the product.
  • the pressure regulating portion is supported on, or comprises, a transversing wall 452 which extends in any suitable manner across the cross section of the valve body. Said transversing wall 452 does not have to be perpendicular to the longitudinal axis of the valve body but may be inclined to said axis, nor does said transversing wall have to be flat - it may comprise different levels or steps as it extends from one side of the valve body to the opposite side.
  • the transversing wall prevents any fluid communication between opposite sides of the transversing wall except through specifically arranged passages and through holes.
  • the transversing wall 454 has an inlet passage 455 which is open to the interior of the vessel to which the valve assembly can be fitted and leads to the inlet of pressure regulating valve.
  • the valve stem penetrates the transversing wall 452 and opens out into the vessel.
  • a seal 456 is provided between the valve stem and the transversing wall to prevent leaks.
  • valve assembly in order to allow a vessel or bag within a vessel to which the valve assembly is attached to be filled while at the same time preventing any contents of the vessel, such as pre-filled product concentrate, from escaping, the valve assembly is provided with a bypass pathway 458 which leads from the exterior of the valve body to a position in fluid communication with the interior of the vessel or bag within the vessel (called vessel for brevity in the following) which is to be filled.
  • the bypass pathway 458 provides a route for filling a vessel wherein the route bypasses the pressure regulating valve.
  • the bypass pathway can be formed as required, for example, as shown here, as the portion of the central bore which is between the transverse bore 438 and an opening 459 in the second end 436 of the valve stem, and comprises a flow control valve 460 which can be any type of non-return valve., such as a spring-loaded ball valve or a duck-billed valve, which opens during filling of the vessel in order to allow the passage of fluid from the outside of the valve assembly via the bypass pathway to the interior of the vessel but which is normally closed in order to prevents the flow of fluid from the interior of the vessel to the exterior of the valve assembly.
  • a flow control valve 460 which can be any type of non-return valve., such as a spring-loaded ball valve or a duck-billed valve, which opens during filling of the vessel in order to allow the passage of fluid from the outside of the valve assembly via the bypass pathway to the interior of the vessel but which is normally closed in order to prevents the flow of fluid from the interior of the vessel to the exterior of the valve assembly.
  • the flow control valve preferably is set to open when it is exposed to an opening or cracking pressure PC which is higher than the dispensing pressure of the valve assembly and which is lower than the operating pressure Po which the vessel is intended to contain during use.
  • the cracking pressure is greater than the dispensing pressure PD by 200 kPa or more.
  • the flow arrangement could comprise a means for permanently sealing the bypass pathway after filling has taken place, for example a plug which could be placed in the bypass pathway to prevent flow though it and thereby prevent reuse of a valve assembly.
  • a bypass pathway according to the present invention may be in the form of a channel which extends from the metering chamber through the partition wall and into the vessel as shown in figure 8 below.
  • the filling path would therefore be through, or beside, the valve stem into the metering chamber and then though the bypass pathway into the vessel.
  • the maximum dispensing pressure is 1600 kPa
  • the maximum cracking pressure of the flow control valve is 2500 kPa
  • the maximum operating pressure inside the rigid vessel is 2000 kPa after filling and the maximum filling pressure is 5000 kPa.
  • the minimum dispensing pressure is 500 kPa
  • the minimum cracking pressure of the flow control valve is 100 kPa.
  • the minimum operating pressure inside the rigid vessel after filling is 600 kPa.
  • the minimum filling pressure is 900 kPa.
  • the dispensing pressure is equal to or greater than 1350 kPa and less than or equal to 1600 kPa. Even more preferably the cracking pressure of the flow control valve equal to or greater than 100 kPa and less than or equal to 2500 kPa. Even more preferably the operating pressure inside the rigid vessel after filling is equal to or greater than 1500 kPa and less than or equal to 1800 kPa. Even more preferably the filling pressure is equal to or greater than 2500 kPa and less than or equal to 4500 kPa.
  • valve stem extends directly into the vessel during use.
  • valve stem may be sliding engaged in a hollow sleeve which is itself in fluid connection with the interior of a vessel, or it may be in fluid connection to the interior of the vessel by some other means.
  • the central bore of the valve stem forms the bypass pathway 458 which bypasses the pressure regulating chamber and allows the passage of fluid from the first end of the valve stem to the interior of the vessel only if the fluid is provided at a pressure which is above the opening pressure of the flow control valve 460.
  • Figure 6A shows the first embodiment of the valve assembly of the present invention when the valve stem has been moved towards the valve body and the sealing projections 432 of the extension of the valve body have closed the fluid dispensing through holes.
  • the transverse bore of the valve stem is inside the metering chamber and the contents of the metering chamber are in fluid communication with the surroundings via the transverse bore and central bore of the valve stem. If the contents of the metering chamber are at a pressure which is higher than the surroundings then the contents of the metering chamber will be dispensed to the surroundings. As long as the pressure in the metering chamber is lower than the opening pressure of the non-return valve in the bypass pathway no fluid will flow from the metering chamber to the interior of the vessel.
  • the open end of the valve stem can be connected to a source of high-pressure fluid at a filling pressure PF.
  • the cracking pressure must be equal to or less than the filling pressure PF. Generally, the higher the difference between the filling pressure and the cracking pressure, the quicker the vessel can be filled.
  • the filling pressure must at least be equal to or greater than the operating pressure. Preferably the filling pressure is greater than or equal to 25 % greater than the operating pressure as this pressure differential can speed up the filling process. More preferably the filling pressure is greater than or equal to 50 % greater than the operating pressure.
  • the time that the valve stem is open to the source of high-pressure fluid is controlled and limited so that the pressure in the vessel reaches the desired operating pressure without being over-pressurised if the filling pressure is close to or above the safe working pressure of the vessel.
  • the fluid at the filling pressure will enter the central bore of the valve stem. Once the pressure in central bore is greater than the cracking pressure of the flow control valve in the central bore then the flow control valve will open and allow the flow of fluid into the vessel. Once the filing time TF necessary for the pressure in the vessel to reach the operating pressure Po has elapsed, or if the pressure measured in the vessel is at the operating pressure, the source of high pressure is disconnected from the valve stem. This causes the pressure in the bypass pathway to drop below the cracking pressure as it falls to ambient pressure and the flow control valve will close, preventing fluid from exiting the vessel via the bypass pathway.
  • valve stem In this embodiment of a bypass pathway, if the valve stem is move to the active position during filling, for example by being depressed by a filling head, then the pressure in the metering chamber will be raised to that of the filling pressure as the high-pressure fluid flows through the transverse bore into the metering chamber. This pressure will be released the first time that the valve stem is depressed after filling.
  • the flow control valve is independent of the position of the valve stem - in such cases it is only necessary to move the valve stem far enough such that the transverse bore is blocked by the seal 426 or to cover the transverse bore by some sealing part of the filling head.
  • the pressure regulating valve is adapted to reduce the pressure inside the vessel to the dispensing pressure. After the vessel has been filled, it is preferable to active the valve stem once in order to purge the metering chamber of any high-pressure fluid which might have entered it during the filling operation. Subsequently, once the valve stem is moved to the active position where the fluid dispensing through holes are no longer obstructed by the projections on the valve stem, the fluid will flow from the vessel via the pressure regulating valve to the metering chamber until the pressure in the metering chamber reaches the dispensing pressure which is regulated by the pressure regulating valve. The valve and vessel assembly are then ready for use.
  • the valve is activated by a user to dispense the contents of the metering chamber by depressing valve stem towards the interior of the valve assembly.
  • this can be achieved by an actuator fitted to an actuator body of an inhaler or mask, or a simple push button attached to the valve stem.
  • the pressure of the fluid at the outlet of the pressure regulating valve will push the valve stem away from the partition wall so that the lateral opening of the valve stem is outside the metering chamber, thereby preventing any fluid from leaving the metering chamber and allowing the metering chamber to be filled with fluid at the dispensing pressure.
  • releasing the valve stem takes away the force acting to hold the projections into contact with the partition wall, so the projections will be lifted away from the partition wall and allow fluid from the pressure regulating valve to enter the metering chamber until equilibrium is approached between the pressures in the metering chamber and the pressure regulating valve. In this manner the metering chamber is refilled with fluid which is at a pressure determined by the pressure regulating valve.
  • a spring 498 (shown by dashed lines in figure 7) may be provided to bias the valve stem away from the partition wall and thereby assist the valve stem in returning from the active position.
  • valve assembly using the above bypass arrangement of the valve stem can be used for filling a vessel which lacks a pressure regulating valve, in which case during use the metering chamber will always be filled with fluid at the same pressure as that which is in the vessel.
  • FIG. 8a shows a second embodiment of a valve assembly in accordance with the present invention.
  • the same reference numbers are used for parts which are identical to or similar in function to that of the first embodiment of the invention.
  • the valve stem does not contain a bypass pathway.
  • the bypass pathway is formed as a channel 466 which extends from the metering chamber to, or through, the transversing wall 452.
  • the channel contains a flow control valve 460 of the type described above which allows the flow of high-pressure fluid into the vessel but not from the vessel. Filing takes place through the valve stem, or as reversed flow outside the valve stem and past the valve stem seal, into the metering camber and then through the bypass pathway into the vessel or bag.
  • the channel has an axially extending exterior wall 468 which projects radially towards the centre of the valve body.
  • the exterior wall preferably has a constant profile and the radial extension of the valve body is provided with a correspondingly shape groove which during use surrounds the profile which thereby forms a guide surface for the axial movement of the valve stem. This also helps to align the dispensing through hole sealing projections on the valve stem with the fluid dispensing through holes.
  • FIGS 9-12 show schematically third and fourth embodiments of valve assemblies according to the present invention which are adapted for use with bag on valve (BOV) systems.
  • the valve assembly is sealingly joined by the transversing wall to the neck 500 of a flexible container (often called a "bag") 502 which is intended to contain the product.
  • a flexible container often called a "bag”
  • This flexible container is inserted into the rigid vessel before filling and the valve assembly connected to the neck 417 of the rigid vessel, by crimping, welding, gluing, using a threaded connection or the like after pressurised gas has been filled into the vessel.
  • the bag subsequently can be filled with product via the bypass pathway.
  • the maximum dispensing pressure is 900 kPa.
  • the maximum cracking pressure of the flow control valve is 1000 kPa.
  • the maximum operating pressure inside the rigid vessel is 1100 kPa after filling and the maximum filling pressure is 1500 kPa.
  • the minimum dispensing pressure is 400 kPa. More preferably the minimum cracking pressure of the flow control valve is 100 kPa More preferably the minimum operating pressure inside the rigid vessel after filling is 600 kPa. More preferably the minimum filling pressure is 1000 kPa.
  • the dispensing pressure equal to or greater than 700 kPa and less than or equal to 900 kPa. Even more preferably the cracking pressure of the flow control valve equal to or greater than 100 kPa and less than or equal to 1050 kPa. Even more preferably the operating pressure inside the rigid vessel after filling is equal to or greater than 800 kPa and less than or equal to 1100 kPa. Even more preferably the filling pressure is equal to or greater than 1000 kPa and less than or 1400 kPa.
  • Figure 13 illustrates the steps in a method for filling a vessel connected to a valve assembly according to the present invention, which method comprises the steps of:
  • a source of high-pressure fluid (which may be a compressed gas, or compressed gas and product for pMDI systems, or a product for BoV systems) at a predetermined filling pressure;
  • valve stem or providing a reverse flow pathway to the metering chamber so that there is a fluid communication pathway between the valve stem and the bypass pathway, flow control valve and interior of the vessel.
  • this may entail covering the transverse bore 438 in the valve stem, for example by surrounding it with the filling head or a separate cover, or depressing the valve stem so that the transverse bore is in the metering chamber.
  • bypass pathway is not in the valve stem
  • this can be achieved by depressing the valve stem so that the transverse bore is in the metering chamber so that the filling fluid can travel into the valve stem, leave the valve stem by the transverse bore, enter the metering chamber, flow to the inlet of the channel forming the bypass pathway, flow to the flow control valve, flow past the flow control valve and enter the vessel, or by forcing the filling fluid past the valve stem to atmosphere seal (which normally prevents pressurised fluid inside the valve assembly from exiting the valve assembly) in the reverse direction into the metering chamber;
  • Interrupting the supply of high-pressure fluid can be performed by disconnecting the filling head from the valve stem and/or by closing a valve between the high-pressure fluid supply and/or, if relevant, by raising the valve stem.
  • valve stems of the valve assemblies of the present invention can be filled using prior art filling heads adapted as necessary to the dimensions of the valve stem.
  • the flow resistance in the pathways used for filling should be minimised while at the same time the dispensing characteristics of the valve stem are preferably remain unchanged compared to prior art valve stems.
  • Some conventional valve stems have a central bore and transverse bore diameter of 1.0 mm which restricts the filling speed to a certain rate but gives a satisfactory dispensing plume.
  • the flow control arrangement is fitted as close to the second (internal) end of the valve stem as possible to allow a continuously large bypass pathway bore diameter for as long as possible.
  • it could be in the form of a duck-billed valve fitted onto the second end of the valve stem. If the valve stem has a diameter of 3.6 mm and the central bore has a diameter of 1.0 mm from the first end to the transverse bore, then the bore of the following bypass pathway could be 1.5 mm or 1.6 mm or more. This reduces the resistance to flow during filling and also provides a large diameter passageway for inserting the flow control arrangement into the valve stem.
  • the flow control arrangement may have a diameter which is slightly larger than that of the bypass pathway, for example 0.05 mm or 0.1 mm larger, so that the flow control arrangement can be inserted into the valve stem with an interference fit and thereby maintained in the desired position.
  • the opening in the first end of the valve stem can be maintained at the desired size for dispensing with the correct plume, for example 1.0 mm, and the diameter of the central bore can increase in the direction towards the flow control arrangement, for example to 1.5 mm.
  • the transverse bore can also have an increased diameter.
  • the channel in the bypass pathway can have a large diameter, preferably, equal to or greater than 1.5 mm, more preferably equal to or greater than 1,6 mm, yet more preferably equal to or greater than 1.7 mm, or more than 1.8 mm or 1.9 mm.
  • the diameter is equal to or less than 2 mm in order to avoid increasing the diameter of the pressure control valve too much.
  • the pressure control valve is fixed in the partition wall or below it. In order to reduce flow resistance, the diameter of the transverse bore in the valve stem can be equal to or greater than 1.5 mm.
  • bypass pathway extends through the wall of the valve body so that it has an inlet opening which is accessible from the exterior of the valve assembly. This permits the filling of an attached vessel without using the valve stem, as a filling head could be adapted to seal against the inlet opening and fill the vessel though the bore of the bypass pathway.
  • Figure 14 a) shows a perspective schematic view of an embodiment of a BoV valve assembly 400 for attachment to the inlet of a spray device vessel.
  • Figure 14b) shows the same view with internal components shown by dotted lines.
  • Figure 14c) shows a cross-section through the valve assembly of figure 14a) when seen from the side.
  • a bypass channel extends all the way through the valve stem and is intended to open out inside the vessel.
  • the components of the valve assembly include a crimpable cap 410, preferably made of a soft metal such as aluminium which encloses and holds, preferably by interference fit or adhesive, a main housing 602, preferably made from an engineering polymer or the like which preferably has been cast or injection moulded.
  • the main body comprises an opening 604 for the valve stem 432 and a valve body to atmosphere seal 416 provides a fluid tight seal between the valve stem, main housing and cap.
  • a metering chamber 422 is formed in the main housing and the base of the metering chamber is formed by a partition wall 426 which acts a metering chamber base 608 and which has a central through hole with seal 612 for the valve stem and a further through hole 614 for a poppet valve biasing means in the form of a compression spring 490 which is part of the pressure regulating valve.
  • the though hole is closed at the lower end by a diaphragm 486 which is part of the pressure regulating valve and which is biased downwards by the regulating compression spring 490.
  • the active surface of the diaphragm facing the spring 490 is Al.
  • a valve housing 620 which has a passageway which extends from below the diaphragm to the entrance to metering chamber.
  • the valve housing is held in place by an interference fit with the main housing 602 and/or by an interference fit with a transversing wall 452 mounted on or below the valve housing.
  • Resilient means such a compression spring 498 which acts upon a locking ring 624 or the like on the valve stem biases the valve stem into the non-dispensing position are arranged inside the transversing wall and/or valve housing 620.
  • the valve housing comprises a valve chamber which surrounds the poppet valve of 478 of the pressure regulating valve.
  • Poppet valve can move towards and away from the diaphragm.
  • the regulating pressure spring pushes the diaphragm against the poppet valve so that it is in the open position.
  • the poppet valve of can be loosely maintained in the valve open position by a weak tension spring 626 which pulls the poppet valve towards the transversing wall 452 and prevents the poppet valve moving into the closed position by the force of gravity when the spray device is inverted.
  • the poppet valve has a collar 628 with an area A2 normal to the direction of movement of the poppet valve and an end surface with an area A3 normal to the direction of movement of the poppet valve.
  • Transversing wall 452 has a circular wall 630 which extends downwards, away from the valve housing, and is able to receive a bag containing the product concentrate.
  • the base of the valve stem comprises a sealing ball 628 which is biased onto a position to close the bypass pathway 458 by a bypass closing spring 468.
  • the closing force of the bypass closing spring is chosen so that the bypass can be opened by applying high pressure gas to the opposite, open end of the valve stem.
  • Figures 15a), 15b) and 15 c) show a corresponding pMDI valve assembly in which like components use the same reference numbers as used for the BoV valve assembly of figures 14a) to 14c).
  • the two valve assemblies are substantially the same, except that the pMDI does not require a circular wall 630 to retain a bag.
  • the pMDI may use a different vessel pressure and dispensing pressure than those used in the BoV example above.
  • Suitable dimensions for some components of the valve assembly are: diaphragm diameter greater than or equal to 2 mm and less than or equal to 4 mm, and/or metering chamber volume greater than or equal to 0.01 ml and less than or equal to 0.50 mm, and/or bypass channel diameter greater than or equal to 0.5 mm and less than or equal to 1.5 mm.
  • valve assemblies (400) for the dispensing of pressurised fluid comprising a valve body (402) with a metering chamber (422) connectable to a vessel with fluid to be dispensed wherein the valve assembly further comprises a pressure regulating valve and a bypass pathway (458) extending past the metering chamber and pressure regulating valve to allow filling of a vessel connected to a valve assembly, wherein said bypass pathway comprises a flow control arrangement (460) which allows one-way fluid flow from the surroundings in the direction towards and into the vessel.
  • a vessel and valve assembly arrangement comprises a vessel and a valve assembly (400) for the dispensing of pressurised fluid from the vessel, wherein said valve assembly comprises a valve body (402) with a metering chamber (422) fluidly connectable via a pressure regulating valve to the neck of the vessel wherein the valve assembly further comprises a bypass pathway (458) extending past the metering chamber and pressure regulating valve to the interior of the vessel to allow filling of the vessel attached to a valve assembly, wherein said bypass pathway comprises a flow control arrangement (460) which allows one-way fluid flow from the surroundings in the direction towards and into the vessel.

Landscapes

  • Chemical & Material Sciences (AREA)
  • Dispersion Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Containers And Packaging Bodies Having A Special Means To Remove Contents (AREA)

Abstract

L'invention concerne des ensembles soupapes (400) pour la distribution de fluide sous pression comprenant un corps de soupape (402) avec une chambre de dosage (422) et une soupape de régulation de pression (460) pouvant être reliée à un récipient avec un fluide à distribuer, l'ensemble soupape comprenant en outre un trajet de dérivation (458) s'étendant au-delà de la chambre de dosage vers le récipient, ledit trajet de dérivation comprenant un agencement de commande d'écoulement (460) qui permet un écoulement de fluide unidirectionnel à partir de l'environnement vers et dans le récipient.
PCT/EP2023/083829 2022-12-02 2023-11-30 Soupape à voie de dérivation et procédé de remplissage correspondant Ceased WO2024115701A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP23817393.4A EP4626616A1 (fr) 2022-12-02 2023-11-30 Soupape à voie de dérivation et procédé de remplissage correspondant

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
SE2251411-1 2022-12-02
SE2251411A SE546567C2 (en) 2022-12-02 2022-12-02 Valve with bypass pathway

Publications (1)

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WO2024115701A1 true WO2024115701A1 (fr) 2024-06-06

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SE (1) SE546567C2 (fr)
WO (1) WO2024115701A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN120777387A (zh) * 2025-09-11 2025-10-14 苏州嘉树医疗科技有限公司 止回阀芯及喷雾器

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2003190248A (ja) * 2001-09-11 2003-07-08 Toto Ltd 人体洗浄装置
JP2004026239A (ja) * 2002-06-26 2004-01-29 Mitani Valve Co Ltd 内容物充填機構およびエアゾール式製品
US9364620B2 (en) 2010-06-01 2016-06-14 Capnia, Inc. Gas dispenser for dispensing accurate doses of therapeutic gas from a reservoir containing highly compressed therapeutic gas
US20170021993A1 (en) * 2012-08-08 2017-01-26 James H. Martin Metering valve

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2002332081A (ja) * 2001-05-10 2002-11-22 Bioactis:Kk ガス噴射弁及びガス注入に用いられる注入治具

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2003190248A (ja) * 2001-09-11 2003-07-08 Toto Ltd 人体洗浄装置
JP2004026239A (ja) * 2002-06-26 2004-01-29 Mitani Valve Co Ltd 内容物充填機構およびエアゾール式製品
US9364620B2 (en) 2010-06-01 2016-06-14 Capnia, Inc. Gas dispenser for dispensing accurate doses of therapeutic gas from a reservoir containing highly compressed therapeutic gas
US20170021993A1 (en) * 2012-08-08 2017-01-26 James H. Martin Metering valve

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN120777387A (zh) * 2025-09-11 2025-10-14 苏州嘉树医疗科技有限公司 止回阀芯及喷雾器

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EP4626616A1 (fr) 2025-10-08
SE2251411A1 (en) 2024-06-03
SE546567C2 (en) 2024-12-03

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