SK10062001A3 - Dosing and delivering system - Google Patents

Abstract

The present invention relates to a dispensing device (1) for a fluid (10), the dispensing device (1) comprising a reservoir (11), a shaft (12), a back seal (13), a damper (14), a piston (151) and a one-way valve (16), the back seal (13) sealing a first end of the reservoir and being displaceable along the shaft, the valve being on the second end of the reservoir, the piston being fixed to one end of the shaft, the piston being located between the valve and the damper, the damper being also fixed to the shaft, the damper being located between the piston and the back seal, whereby the piston has an opened position (151) and a closed position (152), the open position allowing fluid communication between the valve and the part of the reservoir between the piston and the back seal, the displacement of the piston between the opened and the closed position being induced by a displacement of the shaft along its own axis, the pressure in the area comprised between the valve and the piston reducing when the piston is moved from its closed position towards its opened position, the damper collapsing when the piston is moved from its closed position towards its opened position, the only fluid flow from the part of the reservoir situated between the damper and the back seal and the part of the reservoir situated on the other side of the damper being a connecting passage (140) situated in the damper (14) when the piston is moved from its opened position towards its closed position.

Description

Technical field

The invention provides a mechanical device for dispensing and dispensing fluid.

BACKGROUND OF THE INVENTION

Liquid dispensing and delivery devices are widely used in the consumer goods or pharmaceutical industries. These devices should allow good control of the amount of fluid dispensed, as well as good control of the delivery of the dose. Especially in the pharmaceutical sector, precise control of both quantity and delivery is critical. Moreover, it is desirable to manufacture these devices in a repeatable and economical manner. It is an object of the present invention to provide accurate dosing and delivery of fluid through an economical dosing and dispensing device.

SUMMARY OF THE INVENTION

In accordance with the present invention, the above object is achieved by a fluid dispensing device comprising a reservoir, a shaft, a rear seal, a damper (also a thrust damper), a piston and a non-return valve. The rear seal seals the first end of the cartridge and is displaceable along the shaft, the valve is on the second end of the cartridge, the piston is attached to the first end of the shaft and is positioned between the valve and the damper. and a closed position, the open position allowing fluid connection between the valve and the cartridge portion between the piston and the rear seal; the displacement of the piston between the open and closed positions is caused by the displacement of the shaft along its own axis. The pressure of the area contained between the valve and the piston decreases as the piston is moved from its closed position towards its open position and the handlebar expands as the piston moves from its closed position towards its open position. When the piston is moved from its open position towards its closed position, the only fluid flow of a portion of the cartridge located by the intermediate bar and the rear seal and a portion of the cartridge located on the other side of the bar is the duct located in the dam.

A device formed in accordance with the invention has a number of advantages. Since this device comprising a piston having an open position and a closed position allowing fluid connection between the valve and the reservoir, the amount of fluid to be dispensed can be precisely controlled by moving the desired amount of fluid from the reservoir to the valve portion by moving the piston from the closed to the open position. the container and valve prevents uncontrolled emptying of the container by the valve. Further, since the pressure in the region between the valve and the piston decreases as the piston is moved from its closed position towards its open position, moving the piston towards the open position will force a certain force threshold to be overcome or at least equalize the pressure limitation and friction forces of the internal system so that unwanted displacement of the piston is prevented. The delivery of a certain dose is also precisely controlled by the combination of the use of a one-way valve, piston, damper and rear seal. Thus, the one-way valve allows fluid delivery only when the piston is moved forward towards the valve, the piston travel speed being controlled by the size of the connecting channel secured in the damper, in conjunction with the fluid viscosity and force of the mechanism used (e.g. .

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will now be further described with reference to the accompanying drawings, in which:

Fig. 1 - a cross-section of a dispensing device in accordance with the invention having a piston in the open position.

Fig. 2 - a cross-sectional dispensing device in accordance with the invention having the piston in the closed position.

DETAILED DESCRIPTION OF THE INVENTION

The invention solves the dispensing device! 10. Fluid should be understood to mean liquids having different viscosities. Preferred fluids in a preferred embodiment of the invention are pharmaceutical fluids, but other applications, such as air-freshening devices, are also envisaged.

The dispenser 2 comprises a reservoir, which is typically a chamber containing some fluid 10. In a preferred embodiment, the reservoir is substantially gas-tight, thereby preventing or reducing chemical development due to contact, for example with O ₂ or water vapor or air retention outside of the device to avoid mismatches in the amount of fluid to be dispensed.

The dispensing device further comprises a shaft 12, which is typically an elongated element having a longer direction as the main axis, the shaft also normally comprising a portion having a constant cross-section in a plane perpendicular to the main axis, to allow the rear seal 13 to be folded; the rear sealB along the shaftB.

The device further comprises a rear seal B that allows the container H. to be sealed substantially independent of the amount of fluid contained therein. This can be achieved, for example, in that the main part of the cartridge H has a constant cross section in a plane perpendicular to the main axis of the shaft B, the rear seal B has a substantially identical cross section and the cross section of the main seal B is preferably larger at the edges than the constant cross section. was reached r

sealing so that displacement of the rear seal B along the shaft B allows the container H to be sealed along a constant cross-section at any level of the main part of the container H having a constant cross-section, thus allowing sealing in a gas-tight manner of varying volume. In a preferred embodiment, the rear seal B is made of a flexible and flexible material having the shape of an umbrella, or preferably a double umbrella, so that the seal at the periphery of the cross-section always presses against the container !!

The device 1 or 2 further comprises a damper 14, which is preferably a part made of a resilient material and has an umbrella shape that cope with disengagement during movement in one direction and damping during movement in the other direction.

The device of the invention also includes a piston 151 or 152, which is typically a portion having a constant cross-section that is in a plane perpendicular to its major axis, the piston 151 or 152 extending along the major axis. The piston 151 or 152 is displaced in a portion of the cartridge H having a cross-section in a plane perpendicular to the major axis of the piston 151 or 152, which is substantially the same, but preferably marginally smaller than one of the pistons 151 or 152 to allow good sealing. Normally, the major axis of the piston 151 or 152 is parallel or even aligned with the major axis of the shaft 12.

The apparatus further includes a check valve 16. This check valve should be understood to mean that in normal use, the valve 16 will only allow passage in one direction. In a preferred embodiment, the valve 16 is a "self-sealing" valve, as described in principle in, for example, EP-A-0 597 601, EP-A-0 395 380 or EP-A-0 160 336.

An essential feature of the device according to the invention is that the rear seal 13 is a seal of the first end of the cartridge H. This allows the use of a gas-tight cartridge H. which is useful to allow stability of the liquid product 10 and necessary for the operation of the device as described below .

The rear seal 13 should also be displaceable along the shaft 12. This displacement means, for example, a linear or an abbreviated displacement.

The valve 16 is located at the second end of the cartridge. In fact, the cartridge is normally elongated along the main direction of the shaft and comprises only two ends, the first sealed by the rear seal 13 and the second comprising the valve 16.

Piston 151 or 152 is attached to one shaft end.12. In fact, the piston 151 or 152 used in the device 1 or 2 of the present invention is to push the dose of product 100 towards the valve 16. To accomplish this, the piston 51 or 152 is positioned between the valve 16 and the damper 14.

The damper 14 is mounted on the shaft 12 and is located between the piston 151 or 152 and the rear seal 13. In fact, the damper 14 is disposed in a portion 110 of the cartridge U that does not contain a dose ready for dispensing. In fact, the device 1 or 2 according to the invention is mainly intended for multiple use, so that the dam 14 is in the part of the cartridge ii which contains a plurality of doses which are not ready for dispensing because they are not positioned between the piston and the valve. It should be noted that the device! or 2 could also be suitable for a single use.

In order to operate the device of the invention, the piston 51 or 152 has an open position 51 and a closed position 152 open position 51 allows fluid connection 153 between the valve 16 and a portion of the cartridge 11 between the piston 151 and the rear seal 11. This fluid connection 153 allows a batch of product to be positioned prior to dispensing within the portion 100 between the piston 151 and the valve 16.

The displacement of the piston between the open 151 and the closed 152 positions is caused by the displacement of the shaft 12 along its own axis, which is the main axis. The pressure in the portion 100 existing between the valve 16 and the piston is reduced as the piston is moved from its closed position 152 towards its open position 151, thereby generating a partial vacuum. This allows the product to "soak in" the portion of the cartridge 11 located between the piston and the rear seal into the portion 100 between the valve and the piston when the piston goes to its open position 151 ·

The damper 14 expands when the piston is moved from its closed position 152 towards its open position 151. This allows release of the dispensing device and prevents unnecessary reverse forces when the occupant actuates the device, thereby moving or moving the piston from its closed position towards its the open position is prepared for opening by the fluid connection 153 between the cartridge portions between the piston and the rear seal and the valve-piston portion 100 to fill the last portion with fluid through the above-mentioned pressure reduction or partial vacuum, the dose is "soaked in" fluid connection 153. ready for dispensing when pushed by the piston through the valve.

Since the only fluid flow from the reservoir portion located between the damper and the rear seal and the reservoir portion located on the other side of the damper is the channel 40 located in the damper 14 when the piston is moved from its open position to its closed position, this motion leading to delivery. In fact, to deliver a dose 100 positioned between the piston and the valve 16, the piston must be moved from its open 151 towards its closed 152 position, thus sliding the slide 14, because the housing 14 and the piston are mounted on the shaft 12. The damper 14 moves through the fluid 10, thus creating an imbalance in the sealed container 11 between the portion of the cartridge positioned by the intermediate bar 14 and the rear seal 13 and the portion of the cartridge Π. located by the intermediate bar 14 and the piston. This imbalance is compensated by the flow in the connecting channel 140 located in the bar 14, thus controlling the rate of expulsion or delivery of the dose ready to be dispensed by the valve 16 by controlling the movement of the piston. In fact, the piston will have a maximum speed depending marginally on the compressibility and especially on the viscosity of the fluid and on the geometric and / or mechanical characteristics of the device. For example, the larger the connecting channel 140 or the greater the force applied to the shaft 12, the greater the maximum speed of the piston.

In a preferred embodiment, the shaft is made of a current conducting material such as metal. In a preferred embodiment, the fluid is electrically charged prior to dispensing. The device according to the invention is particularly suitable for this use since the charging of the fluid will be facilitated by the flow control. In particular, there is a maximum rate at which the charging of the fluid becomes difficult or impossible, so that a damped delivery allows good charging. In order to achieve efficient electro-hydrodynamic atomization of the fluid, the charge rate is proportional to its flow rate.

In a preferred embodiment, the volume contained between the piston in the open position and the valve is less than 100μ1.

In yet another preferred embodiment, the dispensing control is such that the volume of fluid dispensed in each dispensing operation varies by less than 10% between each dispensing operation. Even more preferably, this variation is less than 5%.

In yet another preferred embodiment, the compressed spring is located at one end of the shaft opposite the one on which the piston is mounted and applies pressure on the shaft in a direction substantially parallel to the shaft axis.

In a further preferred embodiment, the connecting channel provided in the damper is a single opening, more preferably a circular opening.

The most preferred embodiment of the present invention is achieved by integrating the device of the invention into a spray device as described in the pending application Nos. GB9806937.0 and GB9806939.6.

Such a spray device is particularly suitable for the treatment of diseases affecting the nasal region, such as hay fever or its clogging due to cold. Recently, it has been recognized that mucous membranes of the nasal cavity may be used as a convenient delivery site for drugs targeting other areas of the human body. See, for example, WO 92/11049 which describes a pen-shaped device for nasal administration, in particular insulin. The spray form is often suitable for such treatment. The treatment of the eyes may also suitably be performed with a spray device. Preferred volume dosages for such uses are generally low, up to less than 10μ1. Repeated dosing will typically be required to achieve a fully effective treatment. Achieving a smooth flow during its delivery from spraying devices delivering such small volumes can be difficult. Typical problems encountered include residual leakage from the valve after use, with the possibility of its re-contamination and clogging.

The use of an elastomeric valve, in particular a slotted valve, ensures a smooth flow from start to finish without clogging, namely by connecting the valve (smooth start) and sudden pressure relief through the pressure relief area (smooth stop), even if the spray liquid contains finely divided, particulate solid .

Preferably, the spray device is adapted to provide one or more unit doses of fluid, each dose having a content in the range of about 1 to about 100 μΐ. The device includes an elastomeric self-sealing valve having a fluid side and a delivery side, the valve opening allows fluid to pass when pressure is applied to the fluid on the fluid side, and a seal when this pressure is removed.

The spraying device is preferably an electrostatic spraying device which offers spraying prior to entering the nostrils.

Fluids

The device of the invention preferably comprises a fluid reservoir comprising a pharmaceutically acceptable fluid, a fluid comprising a pharmaceutically acceptable treatment agent selected from drugs, flavors, salts, active surfactants, and mixtures thereof. Optionally, the fluid comprises other adjuvants dissolved or dispersed therein. The fluid may be aqueous or not. Suitable aqueous fluids comprise water and mixtures of water with water miscible solvents such as glycerol, propylene glycol or alcohols such as ethanol or isopropyl alcohol. Aqueous emulsions, either water in oil or oil in water, may also be used. Preferably, the fluid is an aqueous solution, oil-in-water dispersion or emulsion. Suitable non-aqueous liquids include polyethylene glycols, glycerol, propylene glycol, dimethyl isosorbate, silicone oils, ketones, ethers, and mixtures thereof.

Although not limited to any particular resistance range, the invention has an exceptional application to low resistance fluids, particularly those having a volume resistance of less than 1 x 10 ⁸ ohm.cm, preferably those having a resistance less than 1 x 10 ⁴ ohm. cm, preferably less than 1x10 ³ ohm.cm. If necessary, the fluid may include resistance modifiers such as some pharmaceutically acceptable salt to bring the volume resistance within the desired range.

Preferably, the fluid is a pharmaceutically acceptable intranasal carrier. The nasal composition is preferably isotonic, i.e., has the same osmotic pressure as the blood and the lacrimal fluid. The desired isotonicity of the composition of the invention may be achieved using, for example, sodium chloride already present or other pharmaceutically acceptable means such as jedextrose, boric acid, citric acid, sodium tartrate, sodium citrate, sodium phosphate, potassium phosphate, propylene glycol or other organic or inorganic solutes. Sodium chloride is particularly preferred for aqueous solutions containing sodium ions. Further examples of sodium chloride equivalents are described in Remington's Pharmaceutical Sciences, p. 1491-1497 (Alfonzo Gennaro, 18th ed., 1990), which is incorporated herein by reference.

drugs

The fluid may comprise a wide variety of drugs. "Drug" means a drug or other substance that is expected to have a therapeutic effect on the human body. Suitable drug levels are from 0.001 to 20%, preferably from 0.01 to 5%, more preferably from 0.1 to 5%. It is understood that the levels of particular drugs depend on a number of factors including their strength, safety profile, solubility / ease of dispersion, and the intended effect. When used, the medicinal product may be expected to have an effect at the site of use, for example as a release, antihistamine or anti-inflammatory drug, or may be envisaged for systematic absorption such as an anti-viral, anti-repressive drug. , against release or against sweating, any hormone and the like. The drug may be soluble in a particular fluid or may be insoluble, a finely divided particulate fluid, or a solid body dispersed in a fluid.

Suitable release agents include oxymetazoline, tramazoline, xylometazoline, naphazoline, tetrahydrazoline, pseudoephedrine, ephedrine, phenylephrine, pharmaceutically acceptable salts thereof such as hydrochlorides, and mixtures thereof. Preferred release agents are selected from oxymetazoline, xylometazoline, pharmaceutically acceptable salts and mixtures thereof. Particularly preferred for use herein is oxymetazoline hydrochloride which is water soluble. When used in the compositions of the present invention, the release agent is preferably present at a concentration of from about 0.01% to about 3%, more preferably from about 0.01% to about 1%.

Antihistamines useful in the present invention include, but are not limited to, fast acting histamine H-1 receptor antagonists. Such H-1 receptor antihistamines may be selected from the following classes of antihistamines: alkylamines, ethanolamines, ethylenediamines, piperazines, phenolthiazines, piperidines. Examples of useful, fast-acting antihistamines include acrivastine, carbinoxamine, diphenhydramine, chloropheniramine, bromopheniramine, dexchloropheniramine, doxylamine, clemastine, promethazine, trimeprazine, methdilazine, hydroxyzine, pyrilamin, tripelenamine, meclizine, meclizine, meclizine, meclizine, meclizine, acceptable salts and mixtures. Other useful antihistamines include terfenadine, azelastine, cetirizine, astemizole, ebastine, ketotifen, lodoxamide, loratadine, levocabastine, mequitazine, oxatomide, setastine, tazifylline, temelastine, or pharmaceutically acceptable salts and mixtures thereof. When used in the compositions of the present invention, the antihistamine component is preferably present in concentrations of from about 0.01% to about 3%, preferably from about 0.01% to about 1%.

The medicament may also be an anti-inflammatory agent such as a corticosteroid. Particularly preferred compositions in this class are glucocorticoids selected from the group consisting of beclomethasone, flunisolide, fluticasone, memethasone, budesonide, pharmaceutically acceptable salts and mixtures thereof. When used in the compositions of the present invention, the anti-inflammatory agent is preferably present in concentrations of from about 0.001% to about 0.1%, preferably from about 0.01% to about 0.1%.

Also useful herein are xanthine derivatives such as caffeine amethylxanthine and the like; antiallergics; mucolytics; anticholinergics; non-opioid analgesics such as acetaminophen, acetylsalicylic acid, ibuprofen, etodolac, fenbuprofen, fenoprofen, ketorolac, flurbiprofen, indomethacin, ketoprofen, narproxen, pharmaceutically acceptable salts and mixtures thereof; opioid analgesics such as butorphanol, leukotriene receptor antagonists; (major) cell stabilizers such as cromolyn sodium, nedocromil and lodoxamides; lipoxygenase-limiting compounds; and nicotine, insulin and calcinotine.

Further examples of suitable medicaments can be found in WO97 / 46243, EP-A-780127, US-A-5 124 315, US-A-5 622 724, US-A-5 656 255 and US-A-5 705 490.

flavors

A variety of flavor and / or aromatic components (for example, aldehydes and esters) may be used in the fluids of the invention. These include, for example, menthol, camphor, eucalyptol, benzaldehyde (cherry, almond), citral (lemon, lime); neral; decanal (orange, lemon); aldehyde C-8, aldehyde C-9 and aldehyde C-12 (citrus fruit); tolylaldehyde (cherry, almond); 2,6-dimethyloctanal (green fruit); 2-dodecenal (citrus, mandarin); aherbals such as jyme, rosemary and sage oil. Additional flavoring ingredients suitable for use in the present invention include those described in U.S. Patent Nos. 4,136,163 to Watson et al; 4,459,425, Amano et al .; and 4,230,688 to Rowsell et al .; all of which are incorporated herein by reference. Mixtures of these aromatic agents may also be used.

Active surfactants

The fluid may also contain one or more pharmaceutically acceptable active surfactants. These surfactants may be useful for dispersing or emulsifying medicaments or flavors, for increasing absorption through the nasal mucosa, or as medicaments per se, such as softening earwax. The surfactants may be anionic, nonionic, cationic or amphoteric, preferably nonionic. Typical nonionic surfactants useful herein include: polyoxyethylene fatty acid derivatives of partial sorbitol anhydride esters such as polysorbate 80; polyoxyethylene fatty acid derivatives such as polyoxyethylene 50 stearate, as well as oxyethylated tertiary octylphenol formaldehyde polymer (available from Sterling Organics as Tyloxapol) or mixtures thereof. Typical concentrations are from 0.1% to 3% by weight.

salt

The fluid may also contain one or more pharmaceutically acceptable salts. The salts may be mineral salts such as, for example, sodium chloride or organic acid salts such as sodium citrate.

Other adjuvants

The fluid may further comprise other additives such as thickeners, humectants, retardants, encapsulating aids, chelating agents preservatives.

The viscosity of the compositions can be maintained at a selected level using a pharmaceutically acceptable thickening agent. Suitable thickeners include, for example, xanthan gum, methylcellulose, microcrystalline cellulose, carboxymethylcellulose, chitosan, hydroxypropylcellulose, hydroxypropylmethylcellulose, hydroxymethylcellulose, hydroxyethylcellulose, carboxy vinyl polymer and the like or an arbomer thereof, or the like. Mixtures of these thickeners may also be used. The preferred concentration of the thickening agent depends on the formulation selected. An important point is to use an amount that reaches the selected viscosity. Viscous compositions are normally prepared from solutions by the addition of such thickening agents.

The fluids useful in the present invention may also contain from about 0.01% to about 5% of a humectant, to limit drying of the mucous membrane and prevent irritation. Any kind of pharmaceutically acceptable humectants can be used, including, for example, sorbitol, propylene glycol, polyethylene glycol, glycerol, or mixtures thereof. With regard to thickeners, the concentration will vary according to the composition chosen, although the presence or absence of these compositions or their concentration is not an essential feature of the present invention.

A pharmaceutically acceptable preservative is generally used to increase the shelf life of the composition of the present invention. A variety of preservatives include, for example, benzyl alcohol, parabens, phenylethyl alcohol, thimerosal, chlorobutanol, chlorohexingluconate, or benzalkonium chloride. The most preferred preservative system for use herein comprises a combination of benzalkonium chloride, chlorhexidyl gluconate and disodium EDTA as a chelating agent. A suitable concentration of preservative will be from 0.001% to 2% of the total weight, although there may be a variation depending on the composition selected.

The device is adapted to provide one or more doses of fluid, preferably multiple doses, each having about a volume ranging from about 1 to about 100µl, preferably from about 1 to about 20, more preferably from about 5 to about 15µ1. The dose volume is preferably preset, but may be adjusted by the user to the desired volume. Preferably, the device is a refill unit, which may be part of a larger device, and which may be replaced or replaced.

The device is preferably adapted to produce a spray having a strand or strip of fluid that extends from the front and has a front end and a delivery end. The spray further comprises a spray cone extending from the delivery end of the fluid strand. By "front end" is meant a point at which a plane (here in the front plane) extending perpendicular to the axis of the strand and just touching the outside of the strand intersects the center of the strand of fluid, preferably having a length of about 1 to about 20 mm more preferably from about 1 to about 10 mm, even more preferably from about 2 to about 8 mm, and in particular from about 3 to about 6 mm, from the front end to the delivery end.

In preferred embodiments, the spray cone has a cone angle of from about 10 to about 90 °, preferably 20 to about 50 °, more preferably from about 30 to about 40 °. In electrostatic devices, the length of the stripe and the spray cone can be adjusted by varying the viscosity or surface tension of the fluid, by varying the fluid flow rate or output velocity, or by varying the valve slot characteristics or valve material properties, by varying the electric field strength by voltage, potential gradient or field enhancing field. electrodes.

The total length of said fluid strand (s) may be, and preferably is, longer than the length from the front end to the delivery end, since said strand preferably originates on the device side of the front plane, for example as an elastomeric self-sealing valve as described herein. , and passes through the passage in the front. The distance from the point of origin of the scrub front is in the range of about 2 to about 15 mm, preferably about 3 to about 10 mm, and more preferably about 5 to about 9 mm. In this way, the front portion can be used as a field amplifier to help control the length of the strand. For this purpose, the front is preferably a non-conductive material such as plastic, which may be, for example, polypropylene, but preferably it is a soft thermoplastic elastomer, providing greater comfort when held against the nose. The elastomers described herein are self-sealing valves. .

Electrostatic devices suitable for strip or fluid spraying are described in WO 96/40441, EP-A-501 725 and co-pending PCT / GB97 / 02746. The present device is preferably a device according to an embodiment according to EP-A-501 725 or PCT / GB97 / 02746, in which the nozzle is formed by mechanical means and a high tension is applied to the nozzle or strip, spreading it into the spray cone. Suitable nozzle speeds are from about 0.5 to about 8, preferably from about 1 to about 3 ms ^-1 .

A suitable high voltage is in the range of about 1 kV to about 15 kV, preferably about 2kV to about 10 kV, and more preferably about 2kV to about 5 kV. This voltage can occasionally be used in the limits of a small, hand-held device from a low-voltage battery (1.5 V is enough) connected to a voltage-increasing transformer. The battery is preferably of a durable type and can be recharged. The generator can be activated by the user via an external switch, which can also be used to mechanically control the pump. The switch preferably comprises a metal part by which the user closes the single-wire high voltage path. A suitable arrangement for the overall design of the device is described in PCT / GB97 / 02746. In this way, the user does not get a net charge. Alternative embodiments using alternating voltage may also be used to prevent charge formation. Preferably, the spray delivery device is activated. Before it disintegrates and forms a spray cone, the spray line is drawn through the nostrils opening into the vestibule and preferably within a short distance of the nasal valve opening.

In order to ensure smooth separation at small unit volumes, the device preferably comprises an elastomeric, self-sealing outlet valve having a fluid side and a delivery side. The opening of the valve allows fluid to pass when pressure is applied to the fluid on the fluid side and the seal when the pressure is removed. A smooth interruption (stopping) is preferably achieved by the piston ending its forward movement in the pressure reducing chamber ( wider diameter), resulting in an immediate pressure drop and subsequent valve closure. By "outlet valve" is meant that the elastomeric valve is the ultimate dispensing valve and that there are no other device elements that mechanically limit or modify the flow of fluid downstream of the valve. In very preferred embodiments, the valve is a slotted valve. The valve may comprise a single slot or multiple intersecting slits and form, for example, a cross shape. Preferably, however, the valve comprises a single slot. Although the valve may be flat, it is preferably dome-shaped, meaning a non-flat valve having a recess such as a hemispherical or frustoconical dome. In preferred embodiments, the valve is substantially in the form of a hemispherical dome having a flange around its periphery so that a collar may be mounted to retain the valve in the device. The diameter of the valve, including the flange, is typically from about 2 to about 6 mm, with a portion of the dome having a diameter of from about 1 to about 4 mm, typically about 2.5 mm and a thickness from the inside out of about 0.5 to about 1.5 mm, suitably about 1 mm. The valve need not have a uniform thickness. In preferred embodiments, the outer surface of the dome of the valve is hemispherical, while the surface is formed with a small flat at the top of the dome where the slit is formed. Suitable slot widths are from about 50 to about 400 µm, preferably from about 150 to about 250 µm. It should be understood that the slot width refers to its longest dimension when it is first formed. The term "elastomer" refers to a material that is both elastically compressible and elastically extensible. A wide range of elastomers may be used, including but not limited to polyurethanes; chloroprene, butyl, butadiene and styrene-butadiene rubbers and silicone elastomers, such as two-part room temperature vulcanizing (RTV) silicones, which are preferred for use herein. Suitable silicone RTVs are available under the trademark NUIL and have a hardness of from about 30 to about 80 units according to Horea A, preferably from about 40 to about 70. The elastomers may optionally be blended with a suitable plasticizer or blowing agent to become more compressible. The elastomer may also have other materials dispersed therein to adjust its properties such as its conductivity. If low tear strength elastomers are used, the slit width may increase if the slit is opened for a longer period of time. The slit valve may be formed by puncture injection or compression molding of an elastomeric seal of the same dimensions and shape as the intended valve, by means of a pin (or pin) with a sharpened tip. The slot width is roughly proportional to the tip width. The tip may be a flat blade, whether it has a polygonal or rounded cross-section. The tip preferably has a polygonal or, in particular, rounded cross-section. It has been found that cone-shaped sharp-edged tips create a cut that behaves more like a flap than an opening in use. This can lead to a nozzle (stream) that is not straight or even forms two or more nozzles, which can lead to unreliable or unpredictable spraying. Suitable tip diameters are from about 100 to 350, preferably from 150 to 25 µm in diameter. When silicone elastomers are used, it is preferred that the piercing tip is retracted rapidly after the gap has been formed to prevent undesired gap growth. Furthermore, it has been found that the geometry of the elastomeric seal and the punching method have a significant effect on the efficiency and reproducibility of the slot formation. A more reliable slot formation is achieved when the seal is punched from within the dome rather than from the outside.

The valve normally opens when pressure is applied to the fluid side and seals when pressure is removed. The pressure used is suitably in the range of about 200 to about 5000mbar (20 to 500 kPa), preferably about 500 to about 3000mbar (50 to 300kPa). The size of the valve flow is generally proportional to the applied pressure and is suitably in the range of about 5 to about 50, preferably about 5 to about 30 µs -1. At such pressures and with the described valve type and slot dimensions, a straight fluid strand is obtained at an output rate of from about 0.5 to about 8, preferably from about 1 to about 3ms ^-1 .

The diameter of the emitter strand is partly determined by the flow rate and is generally less than the width of the slit valve. Depending on the flow rate, strand diameters of less than 50 µm can be achieved even though a valve slot width of 200 µm is used. The diameter of the fluid line strongly influences the particle size of the spray after disintegration into the spray cone, the particle size being roughly similar to the diameter of the strand. It is a feature of electrostatic spraying in the strand fashion that a tightly distributed, almost monodisperse spray is achieved. Thus, it is possible to obtain a spray with an average droplet size of from about 20 to about 80, preferably from about 30 to about 70pm, more preferably from about 40 to about 60pm, the particle size distribution having a standard deviation of less than 5, typically less than 2pm and preferably less than lpm. It is commonly understood that for spraying into the nose, a particle size of 10 µm or less is undesirable so that the particles are not carried through the lungs. However, it is believed that the electrostatic charge on the spray particles makes them much less likely to be carried away from the nose because the charged particles tend to find a fairly grounded surface.

The smooth stop of the spike valve flow can be further improved by introducing a pressure relief arrangement downstream of the valve. This space will provide a sudden pressure drop when the piston enters this area almost completing its impact forward and forcing the valve to close instantaneously and safely with no dripping at the end of the full fluid charge.

The spray device is suitable for spraying or spraying into a cavity of the human body, particularly the nose, mouth or ears. The small volume and fine spray makes it equally applicable to eye spray. It is preferably used for nasal spraying. A preferred method of delivering some fluid to the nasal cavity from such a nebulizer device is to nebulize the fluid into the nasal cavity without substantially penetrating the device into the nostrils or nostrils, meaning that no nozzle or the like is inserted into the nasal atrium. In use, the front portion of the device is preferably placed in contact with the nostril opening in order to obtain full benefit from the effect intensifying field described above in relation to the front portion of the device. If pressure is applied by the user, for example to provide contact or directional assistance, there may be some funnel-like extension of the shotgun or the cartilage overlap of the septum, but the front part is nevertheless completely surrounded by the unremarkable.

Claims (8)

PATENT CLAIMS A fluid dispensing device (1, 2) comprising a reservoir (11), a shaft (12), a rear seal (13), a slide (14), a piston (151, 152), and check valve (16); the rear seal (13) seals the first end of the cartridge (11) and is displaceable along the shaft (12), the valve (16) is on the second end of the cartridge (11), the piston (151, 152) is attached to the first end of the shaft (12) is located between the valve (16) and the dam, the damper (14) is also mounted on the shaft (12) and located between the piston and the rear seal (13), thereby having the piston (151, 152) open (151) and closed (152) the open position allows fluid communication between the valve (16) and the cartridge portion (11) between the piston (151, 152) and the rear seal (13), the displacement of the piston (151, 152) between the open and closed positions is caused by the shaft its own axis, the pressure in the area contained between the valve (16) and the piston (151,152) decreases as the piston is moved from its closed position towards its open position of the handlebar (14) expands when the piston is moved from its closed position to its open position when the piston is moved from its open position towards its closed position by a single fluid flow from the portion of the cartridge (11) located by the intermediate bar (14) and the rear seal (13) and the cartridge portion (11) located on the other side 1, the connecting channel (140) is located in the damper (14). Fluid dispensing device according to claim 1, characterized in that the shaft (12) is made of an electrically conductive material. The fluid dispensing device of claim 2, wherein the fluid is electrically charged prior to dispensing. The fluid dispensing device of claim 1, wherein the volume between the piston in the open position and the valve (16) is less than 10 µm. The fluid dispensing device of claim 1, wherein the volume of dispensed fluid varies (fluctuating) less than 10% between each dispensing operation in each dispensing operation. The fluid dispensing device of claim 1, wherein a spring applying pressure on the shaft (12) in a direction substantially parallel to the end to which the piston (151, 152) is attached is located at the shaft end (12). with shaft axis / 12 /. The fluid dispensing device according to claim 1, wherein the one-way valve (16) is a sealing valve. A fluid dispensing device according to claim 1, characterized in that the connecting channel (140) is a single opening secured to the bar (14).