MXPA06004970A - A fluid dispensing device - Google Patents

A fluid dispensing device

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Publication number
MXPA06004970A
MXPA06004970A MXPA/A/2006/004970A MXPA06004970A MXPA06004970A MX PA06004970 A MXPA06004970 A MX PA06004970A MX PA06004970 A MXPA06004970 A MX PA06004970A MX PA06004970 A MXPA06004970 A MX PA06004970A
Authority
MX
Mexico
Prior art keywords
fluid
container
finger
force
dispensing device
Prior art date
Application number
MXPA/A/2006/004970A
Other languages
Spanish (es)
Inventor
Birsha Davies Michael
Graham Hedley Mark
Jean Jones Margot
Original Assignee
Glaxo Group Limited
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 Glaxo Group Limited filed Critical Glaxo Group Limited
Publication of MXPA06004970A publication Critical patent/MXPA06004970A/en

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Abstract

A fluid dispensing device (5, 105, 205, 305, 405, 505) for dispensing a fluid form medicament formulation having a viscosity of from 10 to 2000 mPa.s. is disclosed and comprises a housing (9, 109, 209, 309, 409, 509) and a fluid discharge device (8, 108, 208, 308, 408, 508) arranged to be actuated by one or more levers (20, 21;120, 121;170;220, 221;320, 321;420, 421;520) to cause actuation of a pump forming part of the fluid discharge device. A pre-load means (28;27, 28;39,40;41, 42, 44;144, 47a, 47b;150, 152, 153;224, 227;342;424x, 446;425a;427, 428;560, 561) is used to prevent actuation of the pump until a pre-determined force is applied to each lever of sufficient magnitude to guarantee the production of a well developed efficient spray from the fluid dispensing device.

Description

A FLUID DISTRIBUTING DEVICE This patent application claims the priority of U.S. Patent Applications Nos. 0325629.4 (filing date November 3, 2003), 0405477.1 (filing date 1 March 1, 2004) and 0420539.9 (filing date September 17). of 2004), each of which is incorporated herein by reference. The present invention relates to a dispenser of medicaments and in particular to a fluid dispensing device for use as a nasal inhaler. It is known to provide a dispenser of medicaments, in which the fluid spray is distributed through a nozzle or orifice in the application of a force by a user to an actuating lever or button. Such devices can be installed to distribute a single dose or they can be installed alternately with a container containing several doses to be distributed. It is a problem with such a spray of the prior art that if the actuator moves in a slow or unpredictable manner, a well defined and strong spray may not occur and thus the medicament formulation may not be effectively distributed. This problem is particularly significant where an actuator (eg, a lever) acts on a pumping mechanism such as to pump the fluid to be sprayed from a container. In this case, a slow or unpredictable actuation results in a slow or unpredictable operation of the pump and therefore, unreliable spray characteristics. The Applicant has now appreciated that the problem of producing a well-defined spray can be significant when the drug formulation is in the form of a relatively viscous formulation. The formulation can be formulated as a solution formulation, or as a suspension formulation comprising medicament particles suspended in a suspension formulation (which acts as a 'vehicle' for suspending the drug particles). A suspension formulation generally has a relatively high viscosity, since it may assist with the suspension of the medicament particles, and may comprise agents for increasing / controlling the viscosity thereof. In order to solve or alleviate the above-described problems, the dispensing device herein includes a "compromise" feature, which prevents pump actuation in the absence of pre-determined force application to a finger-operable actuator. . It is an object of this invention to provide a fluid dispensing device that is easier to use and in particular a device that provides a more efficient distribution of fluid medicament formulation, particularly one that is viscous in nature. According to a first aspect of the invention there is provided a fluid dispensing device for spraying a fluid in a body cavity comprising a housing, a nozzle for insertion into a body cavity, a fluid discharge device movably received within the housing , the fluid discharge device having a longitudinal axis and comprising a container containing a fluid medication formulation to be dispensed and a compression pump having a suction inlet located inside the container and a discharge tube extending along the longitudinal axis for transferring fluid from the pump to the nozzle and movable operable means with respect to the longitudinal axis of the fluid discharge device to apply a force to the container to move the container-along the longitudinal axis toward the nozzle to drive the pump of compression where a pre-loading medium is provided for Preventing the actuation of the compression pump until a pre-determined force is applied to the means operable by the finger, and wherein said fluid medicament formulation has a viscosity of from 10 to 2000 mPa.s at 25 ° C. In one aspect, the fluid medication formulation is formulated as a solution formulation. In another aspect, the fluid medicament formulation is formulated as a suspension formulation comprising a suspension of active drug particles in an inert suspension formulation. It will be appreciated that in the general operation of the fluid dispensing device the relative movement between the container (eg, a hollow sleeve defining a fluid container) and the compression pump acts to pump fluid from the container into the nozzle to distribute it from the container. same In aspects, the pumping is measured. For example, each pumping action results in the supply of a single dose of fluid from the container to the nozzle. Suitably for metered delivery, the compression pump includes a plunger, which is slidable in a measuring chamber located inside the hollow sheath, the measuring chamber being dimensioned to accommodate a single dose of fluid. The container typically contains several doses of fluid. The term "finger operable" is understood to comprise such operable means by action of the finger or thumb, or combinations thereof of a typical user (eg, an adult or a small patient). In one aspect, the means operable by the finger is movable transverse to the longitudinal axis of the fluid discharge device to apply a force directly or indirectly to the container. In another aspect, the means operable by the finger is movable generally parallel to the longitudinal axis of the fluid discharge device to apply a force directly or indirectly to the container. Other intermediate movements between 'transversal' and 'parallel' are contemplated. In variations, the means operable by the finger can contact the container or engage it to allow the necessary transfer of force.
Suitably, the means operable by the finger is installed to apply mechanical advantage. That is, the means operable by the finger applies mechanical advantage to the user force to adjust (generally to increase or soften) the force experienced by the container. The mechanical advantage can in one aspect, be provided in either a uniform manner such as by an improvement in constant mechanical advantage, for example by a ratio of from 1.5: 1 to 10: 1 (improved strength: initial strength), more typically from 2: 1 to 5: 1. In another aspect, the mechanical advantage is applied in a non-constant manner such as progressive increase or progressive decrease of mechanical advantage over the applied force cycle. The exact profile of variation of mechanical advantage can be easily determined by reference to the desired spray profile and all relevant characteristics of the device and formulation to be sprayed (e.g., viscosity and density). Suitably, the means operable by the finger has a shape, which naturally gives rise to mechanical advantage such as a lever, cam or screw form. The means operable by the finger may comprise at least one lever. connected pivotally to part of the housing and installed to transfer force to the container (e.g., by driving directly therein) to drive the container toward the nozzle when the or each lever is moved by a user. In one aspect, there are two opposing levers, each of which is pivotally connected to part of the housing and can be installed to drive the container to drive the container toward the nozzle when the two levers are squeezed together by a user. Alternatively, the means operable by the finger may comprise at least one lever for applying a force to a driving means used to move the container towards the nozzle to operate the pump. In such a case the or each lever may be pivotally supported at one end. lower inside the housing and the actuating means may, in aspects, be connected to a neck of the container (eg, formed as a collar thereto). Suitably, there may be two opposing levers, each of which is pivotally supported near a lower end of the housing and may be installed to act on the actuating means to drive the container toward the nozzle when the two levers are tightened together by a user. Alternatively, the means operable by the finger may comprise at least one lever slidably supported within the housing to apply a force to the container to move the container towards the nozzle and to drive the compression pump. The pre-loading means acts to prevent the actuation of the compression pump until a pre-determined force is applied to the means operable by the finger. The predetermined force can thus be thought of as a 'threshold' or 'barrier' force which must first be overcome before the actuation of the compression pump can occur. The predetermined force quantum that is to be exceeded prior to the actuation of the allowed compression pump is selected according to several factors including pump characteristics, typical user profile, fluid nature and desired spray characteristics. Typically, the predetermined force is in the range of 5 to 45N, more typically 10 to 25N. That is, typically from 5 to 30N, more typically from 10 to 25N of force must be applied to the means operable by the finger before the activation of the compression pump is allowed. Such values tend to correspond to a force that prevents a suitable 'barrier force' for a finger motion without proposing or wanting, weak while being easily overcome by the actuation of the determined finger (or thumb) of a user. It will be appreciated that if the device is designed for use by a child or elderly patient it may have a predetermined force lower than that designated for use by an adult. According to a first embodiment of the invention, the pre-loading means is physically interposed between the or each operable means of the finger (eg, lever) and the container. In each case, the pre-loading means may comprise a passage formed in the container to be mounted by the or each lever before the compression pump can be operated, wherein the passage is mounted when the predetermined force is applied to the or each lever. Alternatively, the pre-loading means may comprise a step formed in the or each means operable by the finger (for example, lever) that must be mounted by the container before the compression pump can be operated where the step is mounted when the predetermined force is applied to the or each lever. In still a further alternative, the pre-loading means may comprise at least one stop formed in one of the container or the or each means operable by the finger (eg, a lever) and a gap formed in the other of the container or the or each lever, where the or each stop is capable of being dismounted from the gap with which it is engaged when the pre-determined force is applied to the or each lever. According to a second embodiment of the invention, the pre-loading means is interposed between the housing and the container. In such a case, the pre-loading means may comprise one or more detents formed in the container for clutch with part of the housing, the or all stops disengaging from the housing when the predetermined force is applied to the means operable by the finger to allow the compression pump is activated. Alternatively, the pre-loading means may comprise one or more detents formed in the housing for clutch with part of the container, the or all stops disengaging from the container when the predetermined force is applied to the means operable by the finger to allow the pump of compression is activated. According to a third embodiment of the invention, the pre-loading means is interposed between the container and the discharge tube. In such a case, the pre-loading means may comprise a passage formed in the discharge tube and at least one bolt member attached to the container, the installation being such that, when the pre-determined force is applied to the medium operable by the The finger, the or each latch member is capable of mounting the step to allow the compression pump to be driven. Alternatively, the pre-loading means may comprise a gap formed in the discharge tube and at least one latch member attached to the container, the installation being such that, when the pre-determined force is applied to the means operable by the finger, The or each latch member is capable of being dismounted from the gap to allow the compression pump to be driven. According to a fourth embodiment of the invention, the pre-loading means is interposed between the housing and the or each member operable by the finger (for example, lever). In such a case, the pre-loading means may comprise at least one stop formed in the clutch housing with each lever, the or all stops disengaging from the respective lever when the predetermined force is applied to the or each lever to allow the compression pump is activated. Alternatively, the pre-loading means may comprise at least one stop formed in each clutch lever with part of the housing, the or all stops disengaging from the housing when the predetermined force is applied to the or each lever to allow the pump to compression is activated. According to a fifth embodiment of the invention, the pre-loading means is interposed between the actuating means and the housing. In such a case, the pre-loading means may comprise at least one stop formed in part of the clutch actuating means with part of the housing, the or all detentions disengaging from the housing when the predetermined force is applied to the or each operable member. by the finger (eg lever) to allow the compression pump to be driven. Alternatively, the pre-loading means may comprise at least one stop formed in part of the housing each stop being installed for clutch with a complementary hollow formed in part of the drive means, each stop disengaging from its respective hollow when the predetermined force is applied to the or each member operable by the finger (eg lever) to allow the compression pump to be driven.
According to a sixth embodiment of the invention, the pre-loading means is interposed between the or each member operable by the finger (for example lever) and the respective actuating means. In such a case, the pre-loading means may comprise at least one stop formed in the or each clutch lever with a respective recess formed in part of the actuating means, each stop disengaging from its respective complementary recess when the predetermined force is applied. to the lever to allow the compression pump to be driven. Alternatively, the pre-loading means comprises at least one stop formed in each clutch actuating means with a recess formed in a respective lever, each stop disengaging from its respective complementary recess when the predetermined force is applied to the lever to allow the compression pump is activated. As still a further alternative, the pre-loading means (eg comprised in the finger operable means) defines a variable mechanical ratio so that until the predetermined force is applied to the or each finger-operable member (for example, example to lever), no significant force is transferred to the container along the longitudinal axis. The variable mechanical ratio is suitably defined by the interaction profile of a surface of the operable medium by the finger with a follower element provided to the container or an adjustment provided thereto (eg, a collar).
In one aspect, the variable mechanical ratio defines a 'two-step' profile characterized by an initial 'high force' profile. (for example, high gradient) (defining the pre-load force, to be exceeded) and a subsequent 'low force' profile (for example, low gradient). In a particular aspect, the 'high force' and low force 'profiles are linear (ie, straight lines) and have a sharp breaking point between them. In another particular aspect, the 'high force' and low force 'profiles are curved and have a flat / gradual break point between them. In a preferred aspect, the 'high force' and low force 'profiles have circular part profile shapes (for example, as would be defined by overlapping circles of different radii and different centers) and have a breaking point between them. The fluid distributing device can alternatively comprise a means operable by the finger in the form of a single lever and the pre-loading means may further comprise a spring interposed between the lever and the container, the spring being used to drive the container towards the nozzle to operate the compression pump. In such a case the spring can be compressed by the movement of the lever until the predetermined force is applied (ie, by a combination of force applied by the user and stored spring force), at which point the threshold of the medium of load used to prevent the actuation of the compression pump is overcome by force applied to the container so that the container moves rapidly towards the nozzle to drive the compression pump. Suitably, the fluid dispensing device is further provided with force modifying means to modify the force applied to the container. That is, means for modifying the force applied to the (and therefore, ultimately acting) container compared to that force applied directly to the medium operable by the finger by the user. Suitably, the force modifying means acts to amplify the applied force (i.e., comprises force amplifying means). The amplification can be provided in either a uniform manner such as by a constant amplification, for example by a ratio of from 1.5: 1 to 10: 1 (amplified force: initial force, ie, degree of amplification from 1 .5 to 10), more typically from 2: 1 to 5: 1. In another aspect, the amplification is applied in a non-constant manner such as progressive increase or progressive decrease of mechanical advantage over the applied force cycle. The exact profile of the force modification can be easily determined by reference to the desired spray profile and all the relevant characteristics of the device and formulation to be sprayed (e.g., viscosity and density). The force modifying means may in one aspect, be integral with the means operable by the finger. In this aspect, the force modifying means may comprise an aspect of the means operable by the finger formed to give rise to a mechanical advantage (e.g., a lever, cam or screw feature). In another aspect, the force modifying means is located non-integral with the means operable by the finger, and typically between the means operable by the finger and the container. Again in this aspect, the force modifying means may comprise an aspect of the means operable by the finger formed to give rise to a mechanical advantage (e.g., a lever, cam or screw feature). In one aspect, the force modifying means only acts (i.e., only acts to modify the force applied by the user) once the predetermined force has been exceeded. In a preferred aspect, the modifying force acts such that once the predetermined force has been exceeded the force applied to the container is either relatively constant or increases on a relatively constant basis. In a particular aspect, the force modifying means additionally comprises a stopping feature, which acts to stop the force being applied to the container once either a particular maximum force is reached or more typically, once the container has been moved. particular distance. In one aspect, the arrest works to prevent excessive force by applying to the compression pump.
The fluid delivery device herein is particularly suitable for dispensing a fluid medicament formulation. The container therefore contains a fluid medicament formulation for example, formulated either as a solution formulation or as a suspension formulation comprising a suspension of active drug particles in an inert suspension formulation. The medicament particles comprise an active drug, which can be selected from, for example, analgesics, for example, codeine, dihydromorphine, ergotamine, fentanyl or morphine; anginal preparations, for example; diltiazem, antiallergics, for example, cromoglycate (for example, as the sodium salt), ketotifen or nedocromil (for example, as the sodium salt); anti-infectives, for example, cephalosporins, penicillins, streptomycin, sulfonamides, tetracyclines and pentamidine; antihistamines, for example, metapyrylene; anti-inflammatories for example, benclomethasone (for example as the dipropionate ester), fluticasone (for example as the propionate ester), flunisolide, budesonide, rofleponide, mometasone (for example as the furoate ester), ciclesonide, triamcinolone (for example as acetonite), , 9a-difluoro-1 1ß-hydroxy-16-methyl-3-oxo-17a-propionyloxy-and rosta-1,4-diene-17β-carbothioic acid S- (2-oxo-tetrahydro-furan-3-yl) ) ester or 6a, 9a-difluoro-17a - [(2-furanylcarbonyl) oxy] -1 1 -hydroxy-16a-methyl-3-oxo-androsta-1,4-diene-17β-carbothioic acid S-fluoromethyl ester; antitussives, for example, noscapine; bronchodilators, for example, albuterol (for example as a free base or sulfate), salmeterol (for example as xinafoate), ephedrine, adrenaline, fenoterol (for example as hydrobromide), formoterol (for example as fumarate), isoprenaline, metaproterenol, phenylephrine, phenylpropanolamine, pirbuterol (for example as acetate), reproterol (for example as a hydrochloride), rimiterol, terbutaline (for example as sulphate), isoetarin, tulobuterol or 4-hydroxy-7- [2 - [[2 - [[3- ( 2-phenylethoxy) propyl] sulfonyl] ethyl] amino] ethyl-2 (3H) -benzothiazolone; PDE4 inhibitors for example cilomilast or roflumilast; leukotriene antagonists for example montelukast, pranlukast and zafírlukast; [adenosine agonists 2a, for example 2R, 3R, 4S, 5R) -2- [6-Amino-2- (1 S-hydroxymethyl-2-phenyl-ethylamino) -purin-6-yl] -5- (2 -ethyl-2H-tetrazoI-5-yl) -tetrahydro-furan-3,4-diol (for example, as maleate)] *; [inhibitors of a4 integrin for example (2S) -3- [4- ( { [4- (aminocarbonyl) -1-piperidinyl] carbonyl}. oxy) phenyl] -2 - [((2S) -methyl- 2- { [2- (2-methylphenoxy) acetyl] amino.}. Pentaoyl) amino] propanic acid (eg, as free acid or potassium salt)] *, diuretics, for example; amiloride; anticholinergics, for example, ipratropium (for example as bromide), tiotropium, atropine or oxitropium; hormones, for example, cortisone, hydrocortisone or prednisolone; xanthines, for example, aminophylline, choline theophyllinate, lysine theophyllinate or theophylline; therapeutic proteins and peptides, for example, insulin or glucagons. It will be clear to a person skilled in the art that, where appropriate, the medicaments can be used in the form of salts (for example, as alkali metal or amine salts or as acid addition salts) or as esters (for example, esters) lower alkyl) or as solvates to minimize the solubility of the medicament in the propellant. Preferably, the active medicament is an anti-inflammatory compound for the treatment of inflammatory diseases or disorders such as asthma and rhinitis. In one aspect, the medicament is a glucocorticoid compound, which has anti-inflammatory properties. A suitable glucocorticoid compound has the chemical name: 6a, 9a-difluoro-17a- (1-oxopropoxy) -1 1 ß-hydroxy-16a-methyl-3-oxo-androsta-1,4-diene-17β-carbothioic acid S-fluoromethyl ester (fluticasone propionate). Another glucocorticoid compound has the chemical name 6a, 9a-difluoro-17a - [(2-furanylcarbonyl) oxy] -1 1 ß-hydroxy-16a-methyl-3-oxo-androsta-1, 4-diene-17β-carbothioic acid S-fluoromethyl ester. A suitable glucocorticoid compound has the chemical name: 6a, 9a-difluoro-1 1 -hydroxy-16-methyl-17a - [(4-methyl-1,3-thiazole-5-carbonyl) oxy] -3-oxo -androsta-1, 4-diene-17ß-carbothioic acid S-fluoromethyl ester. Other suitable anti-inflammatory compounds include NSAIDs for example, PDE4 inhibitors, leukotriene antagonists, NOS inhibitors, tryptase and elastase inhibitors, beta-2 integrin antagonists and adenosine 2a agonists. The medication is a particulate form. The particulate medicament suitably has an average mass diameter (MMD) of less than 20 μm, preferably between 0.5-10 μm, especially between 1.5 μm. If reduction of particle size is necessary, this can be achieved by techniques such as micronization, wet bead milling and / or microfluidization. Suitable medicament particles can be produced by conventional techniques, for example, by micronization, grinding or screening. Additionally, medicament excipient powders can be formed with particular densities, size ranges, or characteristics. The particles may comprise active agents, surfactants, wall-forming material, or other components considered desirable by those of ordinary experience. In one aspect, the fluid medicament formulation is formulated as a medicament suspension formulation comprising a suspension of active drug particles in an inert suspension formulation, optionally containing other acceptable additive components. The inert suspension formulation is typically aqueous and comprises one or more excipients. By the term "excipient", herein, substantially inert materials are understood to be non-toxic and do not interact with other components of a composition in a harmful manner including, but not limited to, pharmaceutical grades of carbohydrates, organic and inorganic salts, polymers, amino acids, phospholipids, wetting agents, emulsifiers, surfactants, poloxamers, pluronics and ion exchange resins, thixotropic agents and combinations thereof. Suitable carbohydrates include monosaccharides including fructose; disaccharides, such as, but not limited to lactose, and combinations and derivatives thereof; polysaccharides, such as, but not limited to, cellulose and combinations and derivatives thereof; oligosaccharides, such as, but not limited to, dextrins, and combinations and derivatives thereof; polyols, such as but not limited to a sorbitol, and combinations and derivatives thereof. Organic and inorganic salts include sodium or calcium phosphate, magnesium stearate and combinations and derivatives thereof. Suitable polymers include natural biodegradable protein polymers, including, but not limited to, gelatin and combinations and derivatives thereof; natural biodegradable polysaccharide polymers, including, but not limited to, chitin and starch, degraded starch and combinations and derivatives thereof; semi-synthetic biodegradable polymers, including, but not limited to, chitosan derivatives; and synthetic biodegradable polymers, including, but not limited to, polyethylene glycols (PEG), polylactic acid (PLA), synthetic polymers including but not limited to polyvinyl alcohol and combinations and derivatives thereof. Suitable amino acids include non-polar amino acids, such as leucine and combinations and derivatives thereof.
Suitable phospholipids include lecithins and combinations and derivatives thereof. Suitable wetting agents, surfactants and / or emulsifiers include acacia gum, cholesterol, fatty acids including combinations and derivatives thereof. Suitable poloxamers and / or Pluronics include poloxamer 188, Pluronic® F-108, and combinations and derivations thereof. Suitable ion exchange resins include amberlite and combinations and derivatives thereof. Preferred suspension formulations herein comprise an aqueous suspension of particulate medicament and one or more additional components selected from the group consisting of suspending agents, preservatives, wetting agents, viscosity enhancing agents and agents that adjust isotonicity. Suitable suspending agents include carboxymethylcellulose, vegum, tragacanth, bentonite, methylcellulose, and polyethylene glycols. Particular suspending agents are those sold under the trademark Migiyol by Condea Chemie GmbH which comprise capric and caprylic fatty acid ester oils derived from saturated palm and coconut oil and glycerin or propylene glycol. Particular examples include Migiyol 81 0, Migiyol 812 (caprylic / capric, Migiyol 818 (caprylic / capric / triglyceride linoleic), Migiyol 829 (caprylic / capric / succinic triglyceride), and Migiyol 840 (propylene glycol dicaprylate / dicaparate). Suitable preservatives include quaternary ammonium compounds (eg, benzalkonium chloride, benzethonium chloride, cetrimide, and cetylpyridinium chloride), mercurial agents (eg, pheniphenylmercuric nitrate, acetate, and thimerosal), alcoholic agents (eg, chlorobutanol, alcohol of phenylethyl and benzyl alcohol), esters (for example, esters of para-hydroxybenzoic acid), chelating agents such as sodium edetate (EDTA) and other anti-microbial agents such as chlorhexidine, sorbic acid and its salts and polymyxin. The wetting agents function to moisten the medicament particles to facilitate dispersion thereof in the aqueous phase of the composition. Examples of wetting agents that can be used are fatty alcohols, esters and ethers. Preferably, the wetting agent is a nonionic, hydrophilic surfactant, more preferably polyoxyethylene (20) sorbitan monooleate (supplied as the brand product Polysorbate 80). Suitable viscosity enhancing agents include carboxymethylcellulose, vego, tragacanth, bentonite, hydroxypropylmethylcellulose, hydroxypropylcellulose, (e.g., poloxamer 407), polyethylene glycols, xanthine gums of alginates, carageenans and carbopols. Suitable isotonicity adjusting agents act to achieve isotonicity with bodily fluids (eg, fluids from the nasal cavity), resulting in reduced levels of irritation associated with many nasal formulations. Examples of suitable isotonicity adjusting agents are sodium chloride, dextrose and calcium chloride. Suitable thixotropic agents include those sold under the trademark Avicel RC951 NF, which comprises a mixture of sodium salt of carboxymethylcellulose (8.3% to 13.8% and microcrystalline cellulose) Thixotropic agents tend to make the formulation more viscous when static, but are It becomes less viscous when the kinetic energy is applied (for example, by shaking the container.) In another aspect, the fluid medicament formulation is formulated as a solution drug formulation.The formulation can be an aqueous formulation, or in particular embodiments, A non-aqueous formulation Suitable solution formulations may comprise a solubilizing agent such as a surfactant Suitable surfactant agents include a- [4- (1,1-, 3,3-tetramethylbutyl) phenyl] -α-hydroxypoly (ox) polymers -1, 2) Ethanodil) including those from the Triton series for example, Triton X-100, Triton X-1 14 and Triton X-305 in which the number X is broadly indicative of the average number of repeating units of ethoxy in the polymer (typically about 7-70, particularly about 7-30 especially about 7-10) and polymers of 4- (1,1,1,3-tetramethylbutyl) phenol with formaldehyde and oxirane such as those having a relative molecular weight of 3500-5000 especially 4000-4700, particularly Tyloxapol. The surfactant is typically employed in a concentration of about 0.5-10%, preferably about 2-5% w / w based on the weight of the formulation. Suitable solution formulations may also comprise hydroxyl-containing organic co-solvents including glycols such as polyethylene glycols (eg, PEG 200) and propylene glycol; sugars such as dextrose; and ethanol. Dextrose and polyethylene glycol (eg, PEG 200) are preferred, particularly dextrose. Propylene glycol is preferably used in an amount of not more than 20%, especially not more than 10% and is most preferably avoided together. Ethanol is preferably avoided. Organic hydroxyl-containing co-solvent agents are typically employed at a concentration of 0.1-20% or for example, 0.5-1.0%, for example, about 1-5% w / w based on the weight of the formulation. Suitable solution formulations may also comprise solubilizing agents such as such as polysorbate, glycerin, benzyl alcohol, polyoxyethylene castor oil derivatives, polyethylene glycol and polyoxyethylene alkyl ethers (eg, Cremophors, Brij). Other solubilization agents are those sold under the tradename Migiyol by Condea Chemie GmbH comprising oils of capric fatty acid ester and saturated palm and coconut derivative and glycerin or propylene glycol.
A non-aqueous solution formulation is based on Migiyol (trademark) either used transparent to solubilize the drug substance, or as a mixture with propylene glycol and / or polyethylene glycol. Suitable solution or suspension formulations can be established (i.e., using hydrochloric acid or sodium hydroxide) by appropriate pH selection. Typically, the pH will be adjusted to between 4.5 and 7.5, preferably between 5.0 and 7.0, especially about 6 to 6.5. The fluid medicament formulation herein has a viscosity of from 10 to 2000 mPa.s (1 0 to 2000 centipoise), particularly from 20 to 1000 mPa.s (20 to 1 000 centipoise), such as from 50 to 1000 mPa. .s (50 to 1000 centipoise) at 25 ° C. The viscosity of the inert suspension formulation herein is measured by any suitable method. One suitable method for measuring viscosity is by the use of a Brookfield viscometer (trademark) using an appropriate choice of paddle / spindle and liquid volume as guided by the user's manual instructions. Another suitable method for measuring viscosity is by the use of a suitable rheometer such as Rhe Instruments of Advanced Instruments AR500, Techne Tempette Junior TE-8J Water Bath System. In this method, the fluid medicament formulation sample is pre-cut at 20 Pa immediately before analysis. The shear rate (1 / s) is measured over the following shear range: 0.2 to 20 Pa for a period of 1 minute. The profile thus obtained is modeled using the Herschel-Bulkley model. Using this modeled data, the viscosity at a cutting speed of 250 1 / s is calculated. The method suitably employs a parallel plate, using for example, Standard Acrylic Parallel Plate (60 mm) (Acrylic 5660, Flat Plate 6 cm). The conditions of the suitable test method are: Temperature: 25 ° C Sample size: 1.5 ml Space: 250 micrometers. Appropriate flow procedure establishments are: (A) Conditioning Stage: (i) Initial temperature = 25 ° C (ii) Pre-cutting shear stress = 20 Pa Pre-shear duration = 1 minute (iii) Balance duration = 10 seconds (B) Ramp Stage Continues 1: (i) Test Type = Continuous Ramp (ii) Test Establishments: Ramp = Cutting Stress (Pa) from 0.2358 Pa to 20 Pa Duration = 1 minute Mode = Linear (iii) Points sampling = 12 (iv) Temperature = 25 ° C Where the fluid medicament formulation comprises a thixotropic component, or otherwise has a viscosity that is significantly influenced by kinetic energy supplied to it, the appropriate measured viscosity value is the value Minimum constant measured. In this case, a high shear test method is particularly suitable, so that the measured viscosity values will be close to their minimum possible values. The embodiments are contemplated in which the fluid discharge device is reversibly removed from the housing of the fluid dispensing device. In such embodiments, the fluid discharge device comprises a housing assembly and fluid discharge device that is received therefrom. Suitably, a distributor orifice of the nozzle is provided with a reversible stopper. The stopper acts so as to prevent back draining of fluid supplied from the nozzle (in particular, from the area of the tip of the nozzle and generally adjacent to the dispensing orifice). Suitably, the stopper is reversibly mounted to the nozzle (e.g., at the tip) to allow reversible sealing of the dispensing orifice thereof. In use, such a seal acts to minimize drainage of fluid return from the dispensing orifice through the interior of the nozzle. The retainer can have any suitable shape including disc-shaped, when present, the disc can be flat, or in aspects have a concave shape. It will be appreciated that the retainer is generally formed for effective sealing of the clutch with the tip of the dispensing nozzle (i.e., that area proximate to the dispensing orifice) and therefore that the shape of the retainer can be installed to resemble the reverse of that from the tip of the nozzle. The retainer can be formed of any suitable material including those with plastic properties, particularly those with resilient properties. The stoppers made of polymers that occur naturally or synthetically including rubber are contemplated herein. Suitable forms of retainer insertion can be formed in a variety of ways. In one aspect, a stopper in the form of a rubber disk is stamped from a rubber sheet. In another aspect, a disc-shaped retainer is molded (eg, by injection molding process). Suitably, the fluid distributing device may further comprise a protective end layer having an inner surface for clutch with the housing. The end cap is movable from a first position in which it covers the nozzle to a second position in which the nozzle is discovered. Suitably, the stopper is located in the end cap so that when the end cap is in the first (i.e., protective) position the stopper engages the nozzle to seal the nozzle orifice. In the second (ie, position in use) the retainer is disengaged from the nozzle so that the nozzle orifice is no longer sealed. The retainer may form an integral part of the end cap or alternatively, the retainer may be mounted to the end cap. Any suitable method of assembly is contemplated including adhesive assembly, quick setting and welding. In general, the retainer is located on the inside of the final lid. In one aspect, the inner part of the end cap is provided with annular walls defining a cavity for receiving the retainer as an insertion piece thereto. The retainer insert can simply be inserted mechanically or can be fixed adhesively or otherwise. The shapes of the insert of the suitable stopper can be formed in a variety of ways. In one aspect, a stopper in the form of a rubber disk is stamped from a rubber sheet. In another aspect, a disc-shaped retainer is molded (eg, by an injection molding process). In a further aspect, the protective end cap is molded and the retainer is then molded into the formed end cap (i.e., shot casting process). Also provided is a housing assembly for receiving a fluid discharge device for spraying a fluid in a body cavity, said fluid discharge device having a longitudinal axis and comprising a container containing a fluid medicament formulation to be dispensed and a compression pump having a suction inlet located within the container and a discharge tube extending along the longitudinal axis to transfer fluid from the pump to the nozzle, the housing assembly comprising a housing, a nozzle for insertion into a body cavity and means operable by the finger movable transversely with respect to the longitudinal axis of the fluid discharge device to apply a force to the container to move the container along the longitudinal axis toward the nozzle to drive the compression pump in the present means of Pre-charging is provided to prevent the drive of the compression pump until a predetermined force is applied to the means operable by the finger, and in the present said fluid medicament formulation has a viscosity of from 10 to 2000 mPa.s at 25 ° C. According to another aspect of the present invention there is provided a kit of parts comprising a housing assembly as described above and a fluid discharge device which is received therefrom. The fluid discharge device has a longitudinal axis and comprises a container for storing the fluid to be distributed and a compression pump having a suction inlet located inside the container and a discharge tube extending along the longitudinal axis to transfer fluid from the pump to the nozzle.
Suitably, the fluid discharge device herein comprises a pump such as a compression pump. Suitable pumps include VP3, VP7 or modifications, model manufactured by Valois SA. Typically, such precompression pumps are typically used with a bottle container (glass or plastic) able to maintain 8-50ml of a formulation.
Each spray will typically deliver 25-150μl, particularly 50-10Oμl of such formulation and the device is therefore typically capable of providing at least 50 (eg, 60 or 100) metered doses. Other suitable fluid discharge devices include those sold by Erich Pfeiffer GmbH, Rexam-Sofab and Saint-Cobain Calmar GmbH. It is also contemplated that the housing assembly could be supplied as a separate article, in which a user or pharmacist adjusts to the latter a suitable fluid discharge device. According to a further aspect of the present invention there is provided a fluid dispensing device for distributing a fluid medicament formulation having: a distributing outlet from which the fluid medicament formulation is distributed, a container containing a fluid medicament formulation to be distributed; a dispensing member mounted for movement in a direction of distribution along an axis from a first position to a second position causing a dose of the fluid medicament formulation in the container to be distributed from the dispensing outlet, and a member actuator operable by the finger mounted for movement in a driving direction that is generally transverse to the shaft, wherein the actuator member has at least one cam surface and the distributor member has at least one cam follower surface, wherein the actuator member is movable in the driving direction to cause the at least one cam surface to be brought against the at least one cam follower surface to force the at least one cam follower surface to go over the cam surface to raise the distributor member in the direction of distribution from the first position to the second position, where the at least one surface The cam has a section of engagement, oriented at a first angle to the axis, and an adjacent operating section, which is oriented at a second angle to the axis that is greater than the first angle, wherein the device is configured and installed from so that, in use, the at least one cam follower surface goes successively over the engagement and actuation sections of the at least one cam surface, in motion of the actuator member in the driving direction, to elevate the distributor member of the actuator. first position to the second position, and wherein the first angle is selected such that a minimum driving force is required to be applied to the actuator member to cause the at least one cam follower surface to go over the engagement section on the section of actuation, and in the present said fluid medicament formulation has a viscosity of from 10 to 2000 mPa.s at 25 ° C. Suitably, the first angle is in the range of approximately 20-35 °. Properly, the commitment section is flat. Suitably, the minimum driving force is in the range of about 5-45N, particularly 20-45N. Suitably, the second angle is in the range of about 40-60 °. Suitably, the drive section has an arcuate transition portion contiguous with the engagement section. Suitably, the transition portion has a radius of curvature in the range of about 1 -5mm. Suitably, the drive section is arched. Suitably, the actuating section has a first portion of a first radius of curvature contiguous with the engagement section and a second portion, contiguous with the first portion, of a second radius of curvature that is greater than the first radius of curvature .
Suitably, the drive section consists of the first and second portions. Suitably, the engagement section is of a first length and the drive section is of a second length greater than the first length. Suitably, the minimum driving force is in the range of about 25-40N. Suitably, at least one cam follower surface is arcuate. Suitably, the second portion has a radius of curvature in the range of about 15-40mm. Suitably, the actuator member is mounted on the device for movement in an arcuate path in the driving direction. Suitably, the device is configured and installed so that the first angle to the axis is staggered as the actuator member moves in the driving direction. Suitably, the device is configured and installed such that the second angle to the shaft remains constant, or substantially constant, as the actuator member moves in the driving direction. Suitably, the actuator member is mounted for pivotal movement about a first end thereof and the at least one cam surface is placed on the remote actuator member of the first end.
Suitably, the distributor member is a distributor container in which the supply of the fluid product is contained. Suitably, the direction of distribution is an upward direction and the first end of the actuator member is a lower end thereof. Suitably, the at least one cam follower surface is positioned towards an upper end of the distributor member. Suitably, the dispensing container has a pump, which is caused to pump the dose of the fluid product from the dispensing outlet in response to the dispensing container moving in the distribution direction through the actuator member. Suitably, the actuator member is the sole actuator member. Suitably, the dispensing outlet is in a nozzle dimensioned and formed for insertion into a body cavity. Suitably, the mouthpiece is for insertion into a nasal orifice of a human or an animal body. Suitably, the distributor member and housing have cooperating guide members to guide the movement of the distributor member along the axis. Suitably, the cooperating guiding members prevent the rotation of the distributor member about the axis.
Suitably, one of the guide members comprises one passage and the other guide member comprises a passageway. The invention will now be described with further reference to the Figures of the accompanying drawings in which: Figure 1 is a cross section through a fluid dispenser device including a fluid discharge device having a pre-charge means according to a first embodiment of the invention in a ready-to-use state; Figure 2a is an enlarged view of the area indicated by arrow 'A' in Figure 1; Figure 2b is an elongated view similar to that shown in Figure 2a but showing an alternative pre-loading means; Figure 3 is a cross section similar to that of the Figure 1 but showing the fluid dispensing device in use; Figure 4 is a cross section similar to that shown in Figure 1 but showing a pre-loading means according to a second embodiment of the invention; Figure 5 is an enlarged view of the area indicated by arrow 'B' in Figure 4; Figure 6 is a cross section similar to that shown in Figure 1 but showing a pre-loading means according to a third embodiment of the invention; Figure 7 is an enlarged view of the area indicated by arrow 'C in Figure 6; Figure 8 is a side view in the direction of the arrow 'S' in Figure 7; Figure 9 is a cross section of a fluid dispensing device having an alternative mechanism for driving the fluid discharge device to that shown in Figure 1 and having a pre-loading means according to the second embodiment of the invention; Figure 10 is a cross section as shown in Figure 9 but showing the mechanism used to operate the fluid discharge device in an actuated position; Figure 1 1 is a cross section of a fluid distributing device having an alternative mechanism for driving the fluid discharge device to that shown in Figure 1 and having a pre-loading means according to a fourth embodiment of the invention; Figure 12 is a plan view of the area indicated by arrow 'D' in Figure 11; Figure 13 is a cross section of a fluid dispensing device having an alternative mechanism for driving the fluid discharge device to that shown in Figure 1 and having a pre-loading means according to a fifth embodiment of the invention; Figure 14 is a front view of a fluid distributing device having an alternative mechanism for driving the fluid discharge device to that shown in Figure 1 and having a pre-loading means according to the fourth embodiment of the invention with a final lid removed; Figure 15 is a front view of the fluid dispensing device shown in Figure 14 with a final cover in its drag; Figure 16 is an elongated cross-section of the area indicated by arrow 'E' in Figure 17; Figure 17 is a cross section of a fluid dispensing device shown in Figure 14; Figure 18 is a cross section of a fluid distributing device having an alternative mechanism for driving the fluid discharge device to that shown in Figure 1 and having a pre-loading means according to a sixth embodiment of the invention; Figure 19 is a cross section that is similar to that shown in Figure 18 but showing an alternative pre-loading means according to the sixth embodiment of the invention; Figure 19a is an elongated side view of the area occupied by the collar indicated by arrow 'J' in Figure 19; Figure 1 9b is an enlarged perspective view of the collar of Figure 1 9a; Figure 19c is an elongated side view of a first alternative shape of the area occupied by the collar indicated by arrow 'J' in Figure 19; Figure 1 9d is an elongated side view of a second alternative form of the area occupied by the collar indicated by arrow 'J' in Figure 19; Figure 20 is a front view of the fluid dispensing device shown in Figures 18 and 1 9 but showing the use of a pre-loading means according to the fourth embodiment of the invention; Figure 21 is a side view in the direction of arrow 'P' in Figure 20; Figure 22 is a cross section of a fluid dispensing device having an alternative mechanism for actuating the fluid discharge device to that shown in Figure 1 and having a pre-loading means according to the second embodiment of the invention; Figure 23 is a side view in the direction of the arrow T in Figure 22; and Figure 24 is a cross section of the area indicated by arrow 'F' in Figure 22; Figure 25 is a pictorial representation of part of an additional fluid distributing device according to the invention in a ready to use state; Figure 26 is a line diagram showing the relationship between several members forming the fluid dispensing device in a ready to use position; Figure 27 is a line diagram similar to that shown in Figure 26 but showing the position of the members in a discharge state at the end of a supply line; Figure 28 is a pictorial representation of an alternative collar and drive means for use in the fluid dispensing device shown in Figure 25; Figure 29 is a cross section through a fluid distributing device of which the mechanism shown in Figure 25 forms a part; Figure 30 is a side view of another fluid dispensing device of the invention; Figure 31 is a longitudinal sectional view of the fluid dispensing device of Figure 30; Figure 32 is a partial longitudinal sectional view of the fluid distributor device of Figure 30; Figure 33 is an elongated view of area A in Figure 32; Figure 34 is an elongated view of area B in Figure 32; Figure 35 is an enlarged, fragmented bottom plan view of a nozzle of the fluid dispensing device of Figure 30 mounted in a housing of the device; Figure 36A is a schematic plan view of an actuation lever of the fluid dispensing device of Figure 30; Figure 36B is a side view of the lever taken on arrow A in Figure 36A; Figure 37 is a side view of the nozzle of Figure 35; Figure 38 is a schematic representation of a guide mechanism of the fluid dispensing device of Figure 30; Figure 39 is an enlarged view of one of a pair of peaks of the lever of Figure 36A having a cam profile; and Figure 40 is a schematic, fragmented view of the lever of Figure 36A in an exterior position relative to the housing of the fluid dispensing device of Figure 30. Referring to Figures 1, 2a and 3, a fluid dispensing device is shown. 5 for spraying a fluid into a body cavity comprising a housing 9, a nozzle 1 1 for insertion into a body cavity, a fluid discharge device 8 movably received within the housing 9, the fluid discharge device 9 having a longitudinal axis and comprising a container 30 for storing the fluid to be distributed and a compression pump having a suction inlet located within the container 30 and a discharge tube 31 extending along the longitudinal axis to transfer fluid from the compression pump to the mouthpiece 1 1 and means operable by the finger 20, 21 movable transversely with respect to the longitudinal axis of the device fluid rga to apply a force to the container 30 to move the container 30 along the longitudinal axis towards the nozzle 1 1 to drive the compression pump and a pre-charge means 28 to prevent the actuation of the compression pump to that a predetermined force is applied to the means operable by the finger 20, 21.
The means operable by the finger is in the form of two opposite levers 20, 21 each of which is pivotally connected to part of the housing 9 and is installed to act on a base portion 35 of the container 30 to drive the container 30. towards the nozzle 1 1 when the two levers 20, 21 are pressed together by a user. The fluid dispensing device 5 comprises a molded plastic body 6 and fluid discharging device 8 and further comprises a final pro-vacuum (not mosyrated) valve having a lower surface for clutch with the body 6 to provide the dispensing nozzle 1 1. The body 6 is made of a plastic material such as polypropylene and defines the housing 9 and the dissolving nozzle 11 such that the housing 9 and the nozzle 11 are made as a single plastic composite. The housing 9 defines a cavity 1 0 formed by a front wall, a rear wall and end walls, first and second 14a, 14b. The dispensing nozzle 1 1 was connected to an eximeter of the housing 9, extends away from the housing 9 and has an external conical shape. The discharge outlet of the compression pump is in the form of the tube supply tube 31 and a tubular guide in the form of an outlet tube 16 is formed inside the nozzle 1 1 to align and locate the supply tube 31. in a manner corrected with respect to nozzle 1 1.
An annular abutment 17 is formed in the outlet tube 16. The annular abutment 17 defines the entrance to an orifice 15 through which the fluid can flow in use and is insulated for abutment with an excrement of the supply tube 31. . The fluid discharge device 8 has a long-axis axis X-X and each of the levers 20, 21 has a surface of abutment 22, 23 insulated at an angle? The longitudinal axis XX of the fluid discharge device 8 for abutment conirates the base portion 35 of the container for converting a force applied to the levers 20, 21 substantially transversely to the longitudinal axis XX of the fluid discharge device 8 at a force lengthwise. of the longitudinal axis XX of the fluid discharge device 8. The nozzle 1 1 has a longitudinal axis that is aligned with the long axis XX of the fluid discharge device 8. This has the advantage that when the compression pump is driven force Applied to the tube supply tube 31 is along the axis of the tube supply tube 31 and bending or bending of the tube of supply 31 will not occur due to the force applied. At least part of the surface of the base portion 35 of the container 30 is inclined at an angle with respect to the longitudinal axis X-X of the fluid discharge device 8 to form an inclined surface, the or each inclined surface being insulated to be actuated by the levers 20, 21 to convert a force applied to the levers 20, 21 substantially subversively to the longitudinal axis XX of the fluid discharge device 8 at a force along the longitudinal axis XX of the fluid discharge device 8. Although in the embodiment described both levers and the container are inclined surfaces to the long axis of the fluid discharge device is not necessary. Alone the container or the levers need to have an inclined surface or some other facility to apply the force - from the levers to the container that could be used. The base portion 35 of the container 30 has two inclined surfaces 37, 38 each insulated for cooperation with a respective one of the levers 20, 21. However, it will be appreciated that the inclined surface of the base portion of the container could be a conical, frusto-conical or spherical-shaped surface. The inclined surface 37 is insulated to cooperate with the abutment surface 22 and the inclined surface 38 is insulated to cooperate with the abutment surface 23. The abutment surface 22 is formed by an edge of a network 24 formed as part of the lever 20 and the abutment surface 23 is formed by an edge of a net 25 formed as part of the lever 21. In the mosylated insialation in Figure 2A, the pre-loading means is inserted between the levers 20, 21 and the holder and as shown is in the small-step shape 28 formed near the end of each abutment surface 22, 23 In the ready-to-use position this lies with one side of the container 30 at the junction of the container side with the base portion 35. The purpose of this step 28 is to prevent the levers 20, 21 from moving the container 30 more than a predeterminated force has been applied to the levers 20, 21. Step 28 formed on each lever. 20, 21 must be mounted by the operator 30 years before the compression pump can be operated. Step 28 is mounted when the predetermined force is applied to each lever 20, 21 and once it is outside pre-deferred the pressure is exceeded by applying to the levers 20, 21 in such a way that the container 30 moves very rapidly towards the nozzle 1 1. This prevents levers 20, 21 from squeezing slowly, which will not produce a uniform spray, and if done very slowly, will cause the fluid to flow out of nozzle 11. Figure 2B shows an allarmerical insula- tion in which the pre-loading means comprises a deignification or protuberance 29 formed in the container 30 and complementary recess 27 formed in each lever 20, 21. The size of the stop 29 is such that it is capable of being dismounted from the recess 27 when the predetermined force is applied to each lever 20, 21. It will be appreciated that at hearings, the hole could be formed in the container and the stop could be formed in the levers. Each of the levers 20, 21 is connected pivoially from the housing 9 by a specific acivive arm. In the mosírada modality each of the levers 20, 21 was connected pivoially to a respective one of the two laminar walls 14a, 14b by a specific acivive arculation 26 although other means of pivoial connection could be used. The fluid discharge device 8 is in most aspects and will only be briefly described herein. The fluid discharge device 8 has a hollow container 30 defining a container confining several doses of the fluid to dissolve and the compression pump that is attached to a neck 34 of the container 30. The container 30 as shown is made from a plastic material Irrelevant or transparent However it will be appreciated that it could be made of other translucent or transparent materials such as glass. The compression pump it includes a plunger (not mosdy) slidably engaged in a pump sheath defining a chamber (not shown) sized to accommodate a single dose of fluid. The plunger is joined to the tube supply tube 31 which is insufflated to be exited from an ejector of the pump for cooperation with the outlet tube 16 of the delivery nozzle 1 1. The plunger includes a footplate (not demixed) soporidly slidable in the chamber formed in the pump sleeve. The fluid is discharged through a discharge channel defined by the tube supply tube 31 in the orifice 15 of the dispensing nozzle 1 1.
The size of the chamber is such that it accommodates a single dose of fluid, the diametre of the chamber and piston combined with the piston rod being such that a complete stroke of the piston in the chamber will produce a change in volume equal to one single dose of fluid. The pump casing was connected to the container 30 so that when the foot moves through a pump reformer (not exposed) in a starting position a new dose of fluid exits in the cylinder through the outlet of the pump. suction in the form of a collecting tube 30 of the container 30 for unloading. Operation of the fluid dispensing device is as follows. From the position shown in Figure 1 in which the end portions of the abutment surface 22, 23 collimately confine the inclined surfaces 37, 38 of the container 30 and the container 30 is abutted with the steps 28 a user first grasps the device. fluid dispenser 5 by the two levers 20, 21. By stipulating that only slight pressure is applied to the levers 20, 21, no fluid will be discharged and the user is able to maneuver the dispensing nozzle 1 1 of the fluid distributing device 5 into the body orifice in which the fluid is required to flow. distribute. This is due to the presence of the pre-charge means formed in alimentary modalities, by the steps 28 of Figure 2A or the detention / gap installation 29, 27 of Figure 2B. If the user then tightens the two levers 20, 21 together with increasing force the predetermined force required to cause the container 30 to be mounted above the steps (or deviations / voids 29, 27) will be achieved and the inferaction of the surface of adjoining 22, 23 with the inclined surfaces 37, 38 will then cause the container 30 to move rapidly towards the nozzle 1 1 as indicated by the arrow 'M' in Figure 3. However, the adjacency surrounds the ejector of the supply pipe. 31 and the annular boundary 17 would prevent movement to supply pipe 31 in the same direction. The effect of this is to cause the supply tube 31 to push the plunger into the pump sleeve thus moving the pump piston in the cylinder. This movement causes the fluid to be expelled from the cylinder to the supply tube 31. The forced fluid in the supply tube is then transferred into the hole 1 5 from where it is ejected as a fine spray into the body orifice. By releasing the pressure applied to the levers 20, 21, the supply tube 31 is pulled out of the pump casing by the backward inferor layer and causes the fluid to be drawn upwards from the collection tube to fill the cylinder. The container 30 will then be allowed to move back into the clutch with the steps 28 formed in the levers 20, 21 for the next operation of the fluid distributor device 5. The actuation procedure can then be partitioned until all the fluid in the container is released. I have used. However, only one or two doses of fluid are normally administered at a time. When the container is emptied a new fluid discharge device 8 is charged into the housing 9 thereby resiating the fluid dispensing device 5 in a usable condition. With reference to Figures 4 and 5 a fluid dispensing device is shown which is in most respects identical to that previously described and for which the same reference numbers are used for similar components. The primary difference between the fluid dispensing means shown in Figures 1 to 3 and that shown in Figures 4 and 5 is that the fluid dispensing device 5 in Figures 4 and 5 uses a second embodiment of the pre-charge means in wherein the pre-loading means 39, 40 is interposed between the housing 9 and the container 30. The pre-loading means comprises two detents 39, 40 formed in the housing 9 for clutch with part of the container . The two stops 39, 40 are disengaged from the container 30 when the predetermined force is applied to the means operable by the finger 20, 21 to allow the compression pump to be driven. Each of the arrests is in the form of an arm 39, which extends downwardly of the housing 9 for clutch with a corner of the neck 34 of the container 30. A free end of each arm 39 has a passage 40 formed in the present, which before the drive is in contact with the neck 34 of the container 30. Operation of the fluid distributor device is as follows. From the position shown in Figure 4 in which the end portions of the abutment surface 22, 23 geniformly adjoin the inclined surfaces 37, 38 of the container 30 and the container 30 is abutting with the steps 40 a user first grasps the fluid distributor device 5 by the two levers 20, 21. Stipulating that only light pressure is applied to the levers 20, 21, no fluid will be discharged and the user is able to maneuver the dispensing nozzle 1 1 of the fluid delivery device 5 in the body orifice in which the fluid is required to flow. distribute. This is due to the presence of the pre-loading means formed by the passages 40 and the arms 39 that prevent the movement of the container toward the nozzle. If the user then presses the two levers 20, 21 with increasing force the arms 39 will begin to tilt outward until the predetermined force is reached, the neck 34 of the container 30 is able to disengage itself from the steps 40 and the interaction of the surface of abutments 22, 23 with the inclined surface 37,38 will then cause the container 30 to move rapidly towards the nozzle 1 1. However, as described previously the abutment surrounds the end of the supply tube 31 and the The annular boundary 17 will prevent movement of the supply pipe 31 in the same direction thereby causing the compression pump to be driven as the supply pipe 31 is pushed into the container 30.
This movement causes the fluid to be expelled from the container 30 into the supply tube 31 and then into the orifice 15 from which it is ejected as a fine spray into the body orifice. In the release of the pressure applied to levers 20, 21 the supply tube 31 is pushed out of the container 30 causing the fluid to fill the pump. The container 30 will then move back into clutch with the passages 40 formed in the arms 39 ready for the next operation of the fluid dispensing device 5. The driving procedure can then be repeated until all the fluid in the container has been used. However, only one or two volumes of fluid doses are normally administered at one time. With reference to Figures 6 to 8 a fluid dispensing device is shown which is in most respects identical to that previously described with respect to Figures 1 to 3 and for which the same reference numbers are used for similar components. The primary difference between the dissipative medium of mosyrate fluid in Figures 1 to 3 and that shown in Figures 6 to 8 is that the fluid dissipating device 5 in Figures 6 to 8 uses a third mode of pre-charge medium in wherein the pre-loading means 41, 42, 43 is interposed between the container 30 and the discharge tube 31. This is the modality that can be used irrespecitably of the mechanism used to operate the pump. The pre-loading means comprises a passage 41 formed in the discharge chute 31 and two latch members in the form of arms 42 joined by a collar 43 to the neck 34 of the container 30. The passage 41 is formed by a flange 44 extending circumferentially around the discharge tube 31 and positioned such that when the pump is actuated the flange 44 does not prevent the passage of the discharge tube 31 in the container 30. The insula- tion is in such a way that, when the predetermined force is applied to the means operable by the finger in the form of the levers 20, 21, the latch members or arms 42 are capable of being mounted on the passage 41 to allow the compression pump to be actuated but when a Force below the predetermined force is applied to the clutch of the arms 42 with the step 41 so that the discharge tube 31 is moved in the container 30. Operation of the fluid distributor device is as previously described and it is suggested that only a light pressure is applied to the levers 20, 21 no fluid will be discharged and the user is able to maneuver the distributor nozzle 1 1 of the fluid distributing device 5 into the body orifice in which the fluid is required to be distributed. This is due to the presence of the pre-loading means formed by the passage 41 and the arms 42 preventing the movement of the container 30 towards the nozzle 1 1. If the user then presses the two levers 20, 21 together with increasing force the arms 42 will begin to tilt until the predetermined force is reached, the arms 42 are able to disengage from the passage 41 and the interaction of the surface of abutments 22, 23 with the inclined surface 37,38 will then cause the container 30 to move rapidly towards the nozzle 1 1. This movement causes the fluid to be expelled from the container 30 into the supply tube 31 then into the orifice 15 from which it is ejected as a fine spray into the body orifice. In the release of the pressure applied to levers 20, 21 the supply tube 31 is pushed out of the container 30 causing the fluid to fill the pump. The container 30 will then move again allowing the arms 42 to re-clutch with the step 41 ready for the next operation of the fluid distributing device 5. The actuation procedure can then be repeated until all the fluid in the container has been used.
However, only one or two doses of fluid are normally administered. It will be appreciated that alternatively, the pre-loading means may comprise a gap formed in the discharge tube 31 and at least one latch member or arm attached to the container 30, the insulating being so that, when the predetermined force is applied to the means operable by the finger in the form of levers 20, 21 the or each latch member is capable of being dismounted from the gap to allow the compression pump to be driven. With reference to Figures 9 and 10 there is shown a fluid dispensing device 105 which is in many respects similar to that previously described but in direct drive drive of the fluid discharge device by the levers, the means operable by the finger in the two levers form 120, 121 is used to apply a force to drive means 122a, 122b; 132, 132a, 132b used to move a container 130 toward a nozzle 1 1 1 to drive the pump. For similar parts, corresponding reference numbers will be used for those previously used with respect to Figures 1 to 3. The actuating means 122a, 122b, 132, 132a, 132b was connected to a neck 134 of the container 30. The distributing device of fluid 105 for spraying a fluid into a body cavity comprises a housing 109, a nozzle 1 1 1 for insertion into a body cavity and a fluid discharge device 1 08 movably accommodated within the housing 109. The fluid discharge device 1 08 comprises a container 130 for storing the fluid to be dispensed and a compression pump having a suction inlet located within the container 130 and a discharge outlet 131 at one end of the container 130 for transferring fluid from the pump to the nozzle 1 1 1 .
A means operable by the finger in the form of the two levers 120, 121 is provided to apply a force to the container 1 30 to move the container 130 towards the nozzle 11 for activating the pump. The two opposite levers 120, 121 are supported pivotally in the housing 9 and are operably connected to the container 130 by means of the actuating means to urge the container 130 towards the nozzle 11 when each lever 120, 121 is rotated. by a user and in practice the two levers 120, 121 are tightened together by a user. That is, the tightening of the two levers 120, 121 together causes the holder 130 to move towards the nozzle 1 1 1. In more detail, the fluid dispensing device 105 comprises a housing assembly and the fluid discharge device 108. The housing assembly comprises the housing 109 for movably supporting the fluid discharge device 108, a body 106 defining the nozzle 1 1 1 extending therefrom and the two levers 120, 121 supported in a pivotal manner in the housing 1 09. The body 106 and the nozzle 11 are made as a single part of a plastic material such as polypropylene and the body 106 is adapted at a lower end for clutch with an upper end of housing 109. Body 106 and housing 109 are fixed together by any suitable means. The housing 109 defines a cavity 1 10 formed by a front wall, a rear wall and end walls, first and second, 1 14 a, 1 14 b. The discharge outlet of the pump is in the form of a tubular supply tube 131 and a tube guide in the form of an outlet tube 16 is formed inside of the nozzle 1 1 1 to align and locate the supply tube 131 cor- rectly with respect to the nozzle 1 1 1. An annular abutment 1 17 is formed at the end of the outlet tube 1 16. The annular abutment 1 17 defines the entrance to an orifice 1 15 through which the fluid can flow in use and is installed for abutment with one end of the tube of supply 131. The fluid discharge device 108 has a longitudinal axis coincident with a longitudinal axis of the container 130 and a longitudinal axis of the tube supply tube 131. The nozzle 1 1 1 has a longitudinal axis which is aligned with the longitudinal axis of the fluid discharge device 1 08 so that when the pump is actuated the force applied to the tubular supply tube 131 is along the longitudinal axis of the tube of tubular supply 131 and bending or flexing of the supply tube 131 will not occur due to the force applied. Each one of the levers, first and second, 120, 121 is operably connected to the container 130 near one end of the container 130 where the container emerges in a neck 134. To form the operable connection each of the levers, first and second, 120, 121 has a pair of dented portions 122a, 122b for clutch with a respective reed bar 132 attached to the holder 130 and in particular to the neck portion 134 of the holder 130. Each of the rods 132 is installed to extend parallel to the longitudinal axis of the holder 130. Each of the dented rods 132 has two sets of opposing teeth, a first set of teeth 132a for clutch with the first lever 120 and a second one. assembly of teeth 132b for clutch with the second lever 121. The neck portion 134 of the container 130 has a cylindrical outer surface and the two toothed bars 132 are installed on opposite sides of the neck portion 134 so that the two toothed bars 132 they are installed diametrically opposite with respect to the neck portion 1 34. Each of the toothed bars 1 32 is connected to a collar 140 used for uni r the toothed bars 132 to the neck portion 134 of the container 130. It will be appreciated that the levers 120, 121 may be pivotally connected to the housing 109 in any convenient manner or that each lever 120, 121 could be pivotally supported in the housing. 109 by a pivoial connection between each lever 120, 121 and the body member 1 06. The fluid discharge device 1 08 is as previously described and will not be described again except to mention that the pump action occurs when the discharge tube 131 is pushed into the container 130. The fluid distributor device 105 is adjusted with a pre-loading means according to the second embodiment of the invention, ie the pre-loading means 144 is interposed between the housing 1 09 and the container 1 30. The pre-loading means comprises a stop in the form of a circumferentially extending shoulder 144 formed in the container 130 for clutch with part of the housing 109. The rim 144 is installed for clutch with two inwardly extending extruders 147a, 147b formed in the side walls 1 14a, 1 14b of the housing 109. Each of the ends 147a, 147b is attached to the side wall respective 1 14a, 1 14b being an acivive articulation so that the movement of the exirates 147a, 147b towards the nozzle was avoided but the rotation of the exhausts 147a, 147b relative to the housing 1 09 is possible when they are propelled away from the nozzle 1 eleven . This provides a resistance to the passage of the flange 144 if the container 130 moves towards the nozzle 1 1 1 but offers little resistance to the passage of the flange 144 if the container moves away from the nozzle 1 1 1. Therefore, the stop or flange 144 is of the housing 109 or more specifically the ends 147a, 147b when a predetermined force is applied to the means operable by the finger 120, 121 to allow the compression pump to be driven. Operation of the fluid discharge device 105 is as follows.
First, a user must clamp the fluid dispensing device 105 by the two levers 120, 121, stipulating that only a slight pressure is applied to the levers 120, 121 no fluid will be discharged due to the interaction between the flange 144 and the two ends 147a, 147b and the user is able to maneuver the distributor nozzle 1 1 1 of the fluid distributor device 105 in the body orifice in which the fluid is required to be distributed. If the user then tightens the two levers 120, 121 together with increasing force eventually a predetermined force will be reached at which point the flange 144 is capable of disengaging the housing 1 09 when mounting the ejectors 147a, 147b and the inferaction of the serrated portions 22a , 22b with the bars 132 will then cause the container 130 to move rapidly towards the nozzle 1 1 1. However, because the end of the supply tube 131 is in abutting contact with the annular abutment 1 17, the supply tube 131 can not move in the same direction. The effect of this is to cause the supply tube 131 to be pushed into the container causing the fluid to be expelled from the supply tube 131 into the hole 1 15 where it is expelled as a fine spray into the body orifice. At the end of the supply chamber when the fluid discharge device has been discharged, the two levers 120, 121 have been rotated so that they lie close to or level with the side walls 1 14a, 1 14b as shown in FIG. Figure 10. In the release of the pressure applied to the levers 120, 121 the supply tube 131 is driven out of the pump casing by an infernal return spring and causes the fluid to be pulled up to fill the pump. The operating procedure can then be repeated until all the fluid in the container has been used. However, only one or two volumes of fluid are normally administered at one time. When the container is emptied a new fluid discharge device 108 is loaded into the housing 109 thus restoring the fluid dispensing device 105 in a usable condition. Referring to Figures 1 1 and 12 there is shown a fluid dispensing device 165 which is in many respects similar to that shown in Figures 1 to 3, but in which a single lever 170 is used to apply a force to a medium of drive 176 used to move a container 1 30 towards a nozzle 1 1 1 and drive a compression pump. The lever 170 is supported pivoially in a lower groove of a housing 109 and the driving means 176 is connected to a neck 129 of the container 130 by a collar 140. The fluid dispensing device 165 is fitted with one. fourth embodiment of a pre-loading means in which the pre-loading means 150, 152, 153 is interposed between the housing 109 and the lever 170.
The pre-loading means comprises a stop in the form of a tooth 1 50 formed in the housing 109 for clutch with the lever 170. The tooth 150 is formed at the end of an arm 152 formed as an integral part of the housing 1 09 and the lever 170 has a complementary flange 1 53 formed therein for engagement with the tooth 150. The stop or disengagement 150 is disengaged from the rim 153 on the lever 170 when a predetermined force is applied to the lever 170 to allow the pump of compression is activated. In more detail the fluid dispensing device 165 comprises a body structure including the housing 109, the nozzle 1 1 1 extending out of an upper end of the housing 109 for insertion into a body cavity and a fluid discharging device 1 08 housed so movable within the housing 109. The fluid discharge device 108 comprises the container 130 for storing the fluid to be dispensed and the compression pump having a suction inlet located in the container 130 and a discharge outlet 131 for transferring fluid from the pump. to the nozzle 1 1 1. The lever 170 is supported pivotally in a lower eximere within the housing 1 09 and the driving means is connected to the neck 129 of the container 130 by a collar 140 engaged with the neck 129 of the container 130. The body structure comprises a two-part plastic housing 109 and a plastic body member 106 both of which are molded from a suitable plastic material such as polypropylene. The nozzle 11 is formed as an integral part of the body member 106 and the body member 106 is secured to the housing 109 so that the nozzle 11 is projected from the upper end of the housing 109. The housing 109 has an aperture shape in which the nozzle 11 is formed. a side wall 1 14 of which, in use, a portion of the lever 170 projects. The part of the lever 170 projecting from the opening is an end fastener with flanges 146. The discharge outlet of the pump is in the form of a tubular supply tube 131 and a fibular guide in the form of a tube of outlet 1 16 is formed inside nozzle 1 1 1 to align and locate supply tube 131 correctly with respect to nozzle 1 1 1. An annular abutment 1 17 is formed at the end of the tube. outlet 1 16. The annular abutment 1 17 defines the inlet to an orifice 1 15 through which the fluid can flow in use and is installed to abut one end of the supply tube 131. The fluid discharge device 108 is in most conventional aspects and is as previously described herein. The collar 140 is connected to the neck 129 of the container 130 by a quick connection in which the neck 129 has a slot 141 in which the collar 140 fits. The collar 140 has a slit 142 on one side that allows it to be pushed on the neck 129 and clutched with the slot 141. The driving means is a resilient flexible member in the form of a leaf spring 176 connected to an upper end of the lever 170 for holding the resilient flexible member 176 in an upward inclined state. However, it will be appreciated that more than one flexible resilient member could be used if required. The lower eximere of the lever 170 is pivotally connected to the housing 109 by means of the pin 123. The resilient flexible member 176 is operatively connected to the neck 129 of the container 130 by abutment of an upper surface of the resilient flexible member 176. against a bottom surface 127 of the collar 140, which is attached to the neck 129 of the container 130. A stopping means 125 is provided to limit the roaming movement of the lever 170 away from the container 130 to maintain the resilient flexible member 176 in an inclined state . The means of detention 125 It forms the shape of an edge of the abutment through which the lever 170 projects. The resilient flexible member 176 is connected at one end to the upper end of the lever 170 by clutch with a groove 134 formed in the lever 170 and connected at an opposite end to part of the body structure of the fluid distributor device 165 in the form of the housing 109 having a slot 135 formed therein with which the resilient flexible member 124 engages. It will be appreciated that if the fluid distributor device 165 is removed the resilient flexible member will return to a flat shape as it undergoes non-plastic deformation during use but only elastic deformation. The stop 125 is positioned such that when the lever 120 is completely displaced from the container 130 to rest against stopping 125 the linear distance between the upper end of the lever 120 and the connecting position of the resilient flexible member 176 to the housing 109 is less that the non-inclined length of resilient flexible member 176. This ensures that the flexible member never returns to a flat shape. This is important because the resilient flexible member must tilt up to operate correctly and if it is completely released there is a possibility that in the re-application there is a possibility that in the re-application of a load it will tilt downwards. . When the lever 120 moves toward the container 130 to cause the container 130 to move toward the mouthpiece 1 1 1, the bend radius of the inclined resilient flexible member 176 is reduced and the collar 140 moves upwards thus causing the pump to be actuated. Operation of the fluid distributor device 165 is as follows. After inserting a fluid discharging device 108 into the housing 109 the fluid dispensing device is ready to use and the lever 170 will rest with the final stop 125. To use the fluid dispensing device 165 a user must first grasp the dispensing device. of fluid 165 so that contact is made with the lever 170 and in particular with the flanged end fastener 146. By stipulating that only a slight pressure is applied to the lever 170 no fluid will be discharged and the user is able to maneuver the distributing nozzle 1 1 1 of the fluid dissipating device 165 in a latrine body orifice as a nasal cavity in which the fluid is required to disfribuya. This is due to the presence of the pre-loading means and in particular because the tooth 150 is abutting the flange 153. If the user then exerts more force on the lever 170 the arm 152 will begin to bend and when the force applied the lever 170 reaches a predetermined amount, the tooth 150 is capable of being mounted or detached from the rim 153 to allow the lever 170 to move freely and the direction of the flexible member resilient 176 in the collar 140 will then cause the container 130 to move quickly towards the nozzle 1 1 1. This causes the supply tube 131 to be pushed into the container thus actuating the pump.
In releasing the pressure applied to the lever 170, the resilient flexible member 176 will come to assume the less deformed state and thus will drive the lever 170 back to its stop 125 as soon as the force is removed from the lever 170 allowing the tooth 150 to re-clutch with the flange 153. The actuation procedure can then be repeated until all the fluid in the container has been used. However, only one or two doses of fluid are normally administered at a time. When the container 130 is emptied a new fluid discharge device 108 is loaded into the body member 106 thereby reshaping the fluid dispensing device 165 in a usable condition. With particular reference to Figure 13 there is shown a fluid dispensing device 205 which is in many respects similar to that described with reference to Figure 1 1 but in which two levers 220, 221 pivotally supported at their lower ends are used for moving a holder 230 forming part of a discharge device 208 housed within a housing 206 by means of a driving means in the form of a flexible member 241 which as shown is formed as a single part with the two levers 220,221 but the three parts could be made as separate components. The flexible member 242 is installed to act against a collar 240 connected to a neck 229 of the holder 230 so that when the two levers are squeezed together the flexible member 241 urges the holder toward a nozzle 21 1 exuding from an outlet of the housing 206. The movement of the holder 230 towards the nozzle 21 1 causes relative movement between the holder 230 and a discharge tube 231 connected to a pump housed within the container 230 thus actuating the pump and causing the fluid to be driven out through the discharge tube. 231 in a hole 215 formed in the nozzle 21 1 from, therefore, is dispersed as a fine spray. The fluid dissipating device 205 is adjusted with a fifth mode of a pre-charging means in which the pre-charging means is interposed between the actuating means 241 and the housing 206. The pre-loading means comprises two arrests 224, 227 formed in part of the drive means and in this case on an upper surface of the flexible member 241 for clutch with part of the housing. As can be seen, each of the detents 224, 227 is located such that when the levers 220, 221 are in a rest position they lightly abut against an adjacent exterior surface of the housing 206. When a small force is applied to the two levers 220, 221 the pump is not actuated because the detents 224, 227 prevent the flexible member from moving, but when a force of a predetermined amount is applied to the levers 220, 221 is sufficient to cause the detentions 224, 227 They are disengaged from the housing to allow the compression pump to be actuated. Due to the presence of the deeds 224, 227 it is ensured that the container 230 does not move until sufficient loss is applied to the levers 220, 221 to cause rapid movement of the container 230 towards the nozzle 21 1 and to ensure that a dew occurs cash. It will be appreciated that alternatively, the pre-loading means could comprise at least one stop formed in part of the clutch housing with a complementary recess formed in part of the actuating means. In such a case, each stop would be disengaged from its respective recess when the predetermined force is applied to each lever to allow the compression pump to be driven. Referring to FIGS. 14 to 17, a fluid dispensing device 305 is shown which is in many ways similar to that previously described. The fluid distributor device 305 comprises a body 306 forming a nozzle 31 and a housing 309. A fluid discharge device 308 is housed within the housing 309. The fluid discharge device 308 comprises a container 330 in which a compression pump (not shown) and a discharge tube are fitted. 331 Extending from an exile of the container 330 to adjoining the nozzle 31 1. When the discharge tube 331 moves in the container 330 the pump is actuated and the fluid is driven out of the discharge tube 331 in a hole 315 in the nozzle where it is emitted as a fine mist. It is provided to operable means by the finger in the form of two opposing levers 320, 321 each of which is pivotally supported near a lower end of the housing 309 and is installed to act on an actuating means 322 for driving the container 330 toward the nozzle 31 1 when the two levers 320, 321 are aplying June The actuating means is in the form of two inclined ramps 322 each of which is installed to cooperate with a complementary inclined surface 324a formed in a respective one of the two levers 320, 321. The two ramps 322 are connected to the container 330 by means of a collar 340 that engages with a neck 329 of the container. Movement of the two levers 320, 321 together cause the inclined surfaces 324a to raise the ramps 322 thereby urging the container towards the nozzle 31 1. The fluid dispensing device 305 is adjusted with an inter-load pre-charging means between the housing 309 and the levers 320,321. The pre-loading means comprises a stop or step 342 formed on each side of the housing 309 for clutch with one end side of each lever 320, 321. Movement of the levers 320, 321 is prevented by their clutch with the steps 342 until a predetermined force is applied to them, at such point the applied force is sufficient to cause the ends of the levers 320, 321 to be disengaged from the passages 342 and allow free movement of the levers 320, 321 towards the container 330 thus causing the pump to be actuated. In this way it is ensured that the pump will not be driven until sufficient force is applied to cause rapid movement of the discharge tube 331 in the container 330. With reference to Figure 18 a 405 fluid dispensing device is shown which is in many aspects similar to that previously described with reference to Figures 14 to 17 but in which the pre-loading means is interposed between each lever 420, 421 and the respective actuating means 422. The fluid dispensing device 405 comprises a body 406 forming a nozzle 41 1 and a housing 409. A fluid discharge device 408 is housed within the housing 409. The fluid discharge device 408 comprises a container 430 in which fits a compression pump (not shown) and a tube of discharge 431 being expelled from one end of the container 430 to abut against the nozzle 41 1. When the discharge tube 431 moves in the container 430 the pump The fluid is driven out of the discharge tube 431 into an orifice 415 in the nozzle where it is emitted as a fine mist. A means operable by the finger is provided in the form of the two opposite levers 420, 421 each of which is pivotally supported near a lower end of the housing 409 when connected together by a flexible tape 423 and installed to act in the driving means 422 for driving the container 430 towards the nozzle 41 1 when the two levers 420, 421 are squeezed together. The driving means is in the form of two inclined ramps 422 each of which is installed to cooperate with a complementary curved surface formed in a respective one of the two levers 420, 421. The two ramps 422 are connected to the holder 430 by means of a collar 440, which is engaged with a neck 429 of the holder 430. The ramps 422 and the collar 440 can be made of a plastic material, and can also be formed in an integral manner, for example, mediating molding. Movement of the two levers 420, 421 together causes the curved portions of the levers 420, 421 to climb the ramps 422 thus pushing the container 430 towards the nozzle 41 1. The fluid dissipating device 405 is adjusted with an inert pre-charge means between the drive device 422 and the levers 420, 421. The pre-loading means comprises a stop 424a formed in each drive means in the form of an inclined ramp 422 for clutch with a recess 446 formed in each lever 420, 421. Each of the detents 424a is disengaged from its respective complementary recess 446 when a predetermined force is applied to the respective lever 420, 421 to allow the compression pump to be driven.
Operation of the fluid dispensing device is as previously described when a user holds the two levers 420, 421 with less than the predetermined force movement of the levers 420, 421 which is prevented by the clutch of the deviations 424a with the gaps 446 but so soon as a force equal to or greater than the predetermined force is applied to the levers 420, 421 then the detents 424a are able to disengage or disengage from the recesses 446 and the two levers 420, 421 will move rapidly together thus actuating the compression pump . This ensures that the pump is driven only when sufficient force is applied to ensure the production of an effective spray. It will be appreciated that the pre-loading means could alternatively comprise at least one stop formed in each clutch lever with a respective gap formed in part of the drive means. In that case, each stop would be disengaged from its respective complementary gap when the predetermined force is applied to the lever to allow the compression pump to be driven. Referring to Figure 19 there is shown a fluid dispensing device 405 which is in many respects similar to that previously described with reference to Figure 18 but in which an alternative form of pre-loading means is interposed between each lever 420, 421 and the respective actuation means 422. The same reference numerals are used for similar parts and the construction of the fluid dispensing device 405 will not be described further except as regards the pre-loading means. The characteristics of the driving device 422 can be better understood having reference to Figures 19a and 19b, which show visias, lateral and in perspective, thereof. The pre-loading means comprises a drive device 441 having a collar 440 for receiving by the neck 429 of the container 430. The driving device 441 is provided on opposite sides with ramps 422, each one varying in mechanical proportion so that until a predetermined force is applied to each lever 420, 421 no significant force is transferred to the container 430. This is achieved by having a first portion 425a of each ramp 422 inclined at an angle (eg, about 20 °) to an axis longitudinal (ie, vertical, as shown) of the fluid discharge device 408 which is the remaining length 425b (eg, approximately 45 ° angle) of each ramp 422. Therefore when a force is applied initially to each lever 420, 421 is applied substantially normal to the longitudinal axis of the fluid discharge device 408 and virtually no force becomes a force along the longitudinal axis of the fluid discharge device 408 and thus the static friction between the first portion 425a of each ramp 422 and the cooperating lever 420, 421 is sufficient to maintain the levers 420, 421 fixed. However, when a predetermined load is applied to each lever 420, 421 the static friction is exceeded and each lever 420, 421 is able to initiate movement along the first portion 425a of the cooperage ramp 422. When each lever 420 , 421 reaches the end of the first portion 425a, the change in inclination of the surface with which the lever 420, 421 is cooperating in combination with the magnitude of the force being applied ensures that each lever 420, 421 slides out quickly quickly along the second portion 425b of the cooperating ramp 422 causing the container 430 to move rapidly towards the nozzle 41 1 to drive the compression pump. This ensures that the pump is driven only when sufficient force is applied to ensure the production of an effective spray. As seen in Figures 1 9a and 1 9b, the driving device 441 is also provided on opposite sides of the guide rails 426a, each installed perpendicularly with respect to both ramps 422. The guide rails 426a interact with coupling guides ( not visible) in housing 409 to ensure uniform longitudinal movement of container 430 during actuation. It will be appreciated that the profile defined by the ramps 422 of the drive device 441 of Figures 19a and 19b is that of a linear 'high force' profile (ie, high gradient) 425a (defining the preload force, a overcome) and a subsequent linear (ie, low gradient) linear 'low force' profile 425b with a relatively sharp break point 445 between them. Conveniently, the driving device can be made of a plastic material, for example by molding. Variations of the ramp profiles can be contemplated, as for example, shown in Figures 19c and 19d. The profile defined by the ramps 422 of the drive device 441 of Figure 19c is that of a curved 'high force' profile., initial (ie, high gradient) 425a (defining the pre-load force, to be exceeded) and a subsequent 'low force' profile (ie, low gradient) 425b with a relatively flat / gradual break point 445 enire them. The profile defined by the ramps 422 of the driving device 441 of Figure 19d is that of a 'high force' profile in an initial circular part (ie, high gradient) 425a (defining the preload force, to be exceeded). and a "low force" profile in a subsequent circular part (i.e., low gradient) 425b with a relatively flat / gradual break point 445 enwrap them. In more detail, the profiles of 'high force' 425a and 'low force' 425b can be observed by having profile shapes as would be defined by overlapping circles 425c, 425d of different frayed and different center points (illustrated schematically, underlined only) . Although Figures 19a to 19d have shown embodiments in which double gradient profiles 425a, 425b are provided to ramps 422 on collar 440 that interact with levers 420, 421, it can be seen that on vacation of the same gradient profiles doubled properly configured are provided to the levers 420, 421 for interaction with simple follower elements on the ramps 422 of the collar 440. With reference to Figures 20 and 21, a fluid distributing means is shown which is in most respects identical to that previously provided. described with respect to Figures 18 and 19 and for which the same reference numbers are used for identical parts. The only difference between the fluid dispensing device 405 shown in Figures 20 and 21 and those shown in Figures 1 8 and 19 is the installation of the pre-loading means, which in this case is interposed between each of the levers 420 , 421 and housing 409. In addition, a final cap 407 is shown adjusted in Figures 20 and 21. The pre-loading means comprises two stops or profusions formed in each of levers 420, 421 for clutch with a beveled surface 427 formed around the periphery of an opening in the housing 409 through which the respective lever 421 project When a light force is applied to the two levers 420, 421 is prevented from moving in the housing by the abutment of the detents 428 with the beveled surfaces 427. When the force applied to each lever 420, 421 reaches a predetermined magnitude which is sufficient to deflect the side walls of the levers 420 421 inwards to allow detentions to cross beveled surfaces 427 in housing 409. As soon as detentions have passed over beveled surfaces 427, levers 420, 441 are free to move toward container 430 housed within housing 409 to drive the bomb. Again, this ensures that a reliable dew occurs. When the force is released from the levers 420, 421 are moved back to their initial positions but require the application of a small external force to re-engage the detents 428 with the beveled surfaces 427. With particular reference to Figures 22 to 24 it is shown a fluid dispensing device 505 having a housing 509 for housing a fluid discharge device 508. The housing has a nozzle 51 1 extending out of a clutch end with a body orifice such as a nasal cavity. The fluid discharge device is conventional in nature and as previously described having a container 530 for fluid to dissipate, a fixed compression pump within the container 530 and a discharge tube 531 being expelled out of the pump to supply fluid to the fluid. a hole 515 formed in the nozzle 51 1. As previously described, the pump is driven by pushing the discharge tube 531 into the pump, which is achieved by moving the container 530 towards the nozzle 51 1. A means operable by the finger is provided to move the container 530, the means operable by the finger is in the form of a lever 520 slidably supported within the housing 509 to apply a force to the container 530 to move the container 530 toward the nozzle 51 1 and operate the compression pump. The lever 520 has two projections each of which is slidably supported by means of rails 555, 556 which engage with U-shaped guides 557 formed in the housing 509. A pre-loading means is provided to prevent the pump is operated before a predetermined force is applied to the lever 520. The pre-loading means comprises a spring 558 interposed between the lever 520 and the container 530 and latch means 560, 561. The spring 558 is used to drive the container 530 towards the nozzle 51 1 to drive the compression pump. The resorle is interposed between a collar 540 connected to the holder 530 and a base plate 541. A transfer rod 542 extends out from each side of the clutch base plate with an inclined surface 543 formed in each projection of the lever 520. When the lever 520 is pushed or urged by a user into the container 530 the transfer rods 542 move upward from the inclined surfaces 543 thus compressing the spring 558. However, the container 530 does not move because the collar 540 was connected to the housing 509 by the latch means 560, 561.
The latch means comprises a flange 560 formed in an inner wall of the housing 509 and two outwardly extending arms 561 connected to the collar 540. Each of the arms 561 was connected to the collar at an aric articulation 563 so that when the collar 540 moves towards the nozzle 51 1 the arms 561 are able to adjoin the collar 540 and thus transfer the load to the flange 560 but when the collar 540 moves away from the nozzle 51 1 the arms 561 are able to rise to allow them to pass freely on the flange 560. A return thread 565 is provided to return the lever 520 to its normal rest position when no force is applied to it. Operation of the fluid distributor device is as follows. The application of an initial force to the lever 520 causes the spring 558 to be compressed by the movement of the lever 520 without any movement of the container 530 occurring due to the clutch of the arms 561 with the flange 560. This will continue until a predetermined force applies, at such a point the means used to prevent the operation of the compression pump, ie the arms 561 and the flange 560, are overcome by force being applied to the container 530 by the spring 558 and the container 530 moves rapidly towards the nozzle 51 1 to operate the compression pump. In the release the force of the lever 520 is returned to its rest position by the return resorber 565 and a resorie deniro of the pump returns the holder back to its rest position so that the arms 561 are re-clutched with the flange 560 The use of a resorie to move the container has the advantage that a known force is used to move the container and thus a dew can be produced. Referring to Figures 25 to 29 there is shown an additional embodiment of a fluid dispensing device 605 for spraying a fluid into a body cavity comprising a body structure including a housing 609, a nozzle 61 1 extending outwardly from an upper end of the housing for insertion into a body cavity, a fluid discharge device 608 movably received within the housing 609, the fluid discharge device 608 comprising a container 630 having a neck 629 in an extrude for storing the fluid to be distributed and a compression pump having a suction inlet located within the container 630 and a discharge outlet 631 for transferring fluid from the pump to the nozzle 61 1 and at least one lever 620, 621 to apply a force to an actuating means 622 used to move the holder 630 towards the nozzle 61 1 to drive the pump. The two opposing levers 620, 621 are pivotally supported at a lower end inside the housing 609 and the actuating means 622 is connected to the neck 629 of the container 630 by a collar 640 engaged with the neck 629 of the holder 630. The collar 640 it may be attached or engaged with the neck 629 by any suitable means but preferably the collar 640 is designed to fit over the neck 629 and to be located in a groove formed in the neck 629. This installation using an adjust collar allows a discharge device to be attached to the collar 629. Fluid is used without modification. The fluid dispensing device 605 comprises a plastic molded body 606 and the fluid discharging device 608 and further comprises a protective endcap (not mossed) with an interior surface for clutch with the body 606 to protect the dispensing nozzle 61 1. The body 606 is made of a plastic material such as polypropylene and the body 606 and the nozzle 61 1 are made as a single plastic component and are connected to an upper end of the housing 609 so that the nozzle 61 1 is extruded from the housing 609. The housing 609 defines a cavity formed by a front wall, a rear wall and end walls, first and second, 614a, 614b. Each of the side walls 614a, 614b has an opening 618a, 61 8b formed therein through which the upper end of a resistive of the levers 620, 621 projects. At least one of the front wall and the rear wall has an opening (not shown) therein for viewing the fluid level in the container 630. The discharge outlet of the pump is in the form of a tubular supply tube 631. and a guidewire in the form of an outlet pipe 616 is formed from the nozzle 61 1 to align and locate the supply pipe 631 correcfately with respect to the nozzle 61 1. An annular abutment 617 is formed at the end of the outlet tube 616. The annular abutment 617 defines the entrance to an orifice passage 615 through which the fluid can flow in use and is installed to abut one end of the supply tube. 631 The nozzle 61 1 and the fluid discharge device both have longitudinal axes which are aligned so that when the pump is actuated the force applied to the tubular supply tube 631 is along the axis of the tubular supply tube and bending will not occur. or flexion of the supply tube 631 due to the applied force. The fluid discharge device 608 is in most aspects conventional and will only be briefly described herein. The fluid discharge device 608 comprises the hollow container 630 defining a container containing several doses of the fluid to be dispensed and the compression pump attached to said end of the container 630. The container 630 as shown is made of a translucent plastic material or However, it will be appreciated that it could be made from other translucent or transparent materials such as glass. The pump includes a plunger (not shown) slidably engaged within a pump sheath defining a chamber (not shown) sized to accommodate a single dose of fluid. The plunger is attached to the tubular supply tube 631 which is installed to extend from one end of the pump for cooperation with the outlet tube 616 of the dispensing nozzle 61 1. The plunger includes a piston (not shown) slidably supported in the chamber formed in the pump casing. The fluid is discharged through a discharge channel defined by the tubular supply tube 631 in the orifice passage 615 of the dispensing nozzle 61 1. The size of the camera is such that it accommodates a single dose of fluid, the diameter of the chamber and piston combined with the stroke of the plunger being in such a way that a complete stroke of the plunger in the chamber will produce a change in volume equal to a single dose of fluid. The pump sleeve is connected to the container 630 so that when the piston is moved by a return spring (not shown) in a starting position a new dose of fluid is drawn into the cylinder through the suction inlet in the form of a 630 container collection tube ready for unloading. The two opposite levers 620, 621 are each supported pivoially near a lower exime of the housing 609 by means of pivot pins 623 which pivotally connect each lever 620, 621 to part of the housing 609. The two levers 620, 621 they are installed to act on the driving means 624 to drive the container 630 towards the nozzle 61 1 when the two levers 620, 621 are pressed together by a user. It will be noted that the levers 620, 621 are relatively lengthened to allow mechanical travel to be provided in use. The actuating means comprises at least one elongate member 624 inserted between a position of the collar 640 and an interaction position 'Pl' with a respective lever 620, 621. The infeed position 'Pl' is a position where a final portion of each elongated member 624 reacts confers a stop 625 associated with the respective lever 620, 621. The stop is in the form of a projection or flange 625 on a surface of the respective lever 620, 621 facing the container 630. The projection 625 is formed as an integral part of the respective lever 620, 621 when molded as a part of the lever 620, 621. Alternatively, the stop could be formed by a component attached to the lever or it could be a gap formed in a surface of the respective lever giving the container with which the end portion of the elongated member can be engaged. In any case, the stop 625 is installed to prevent the sliding of the elongated members 624 beyond a position along the length of each lever 620, 621 and are used to transfer load of each lever 620, 621 to the arms. elongated members 624. The elongate members 624 are formed as an integral part of the collar 640 and as shown in Figure 25 there are two elongated members 624 interposed between each lever 620, 621 and the collar 640. As best understood with reference to the Figures 26 and 27 the container 630 has a longitudinal axis XX and each elongated member 624 has a long axis YY and extends the connection position 'PC to the collar 640 and the injector position' Pl 'with the respective lever 620, 621. The longitudinal axis Y-Y of each elongate member 624 is installed at an included angle? with respect to the longitudinal axis XX of the container 630 so that the respective elongated member 624 diverges away from the longitudinal axis XX of the container as it extends from the connection position 'PC to the collar 640 to the interaction position' Pl 'with the respective lever 620, 621. When the or each lever 620, 621 moves to cause the container 630 to move towards the nozzle 61 1, the included angle? between the longitudinal axis YY of each elongated member 624 and the longitudinal axis XX of the container 630 is reduced as shown in Figure 27. This is because when each lever 620, 621 moves to cause the container 630 to move towards the nozzle 61 1, each elongated member 624 associated therewith is subjected to elastic bending. That is, the elongated members are bent but when the applied load is released they return to their normal straight condition. Figure 28 shows an alternative form of the collar 640a and elongate members 624a in which each of the elongated members 624a is formed by a tape or sheet of resilient flexible material. The collar 640a and the elongate members 624a are formed as a single integral part. Referring to Figure 26 if a force F1 is applied to the lever 620 where it is shown then this will result in a force F2 being transferred to the extrude of the two elongated members 624 of the projection 625. Because of the angle at which the elongated members 624 are placed, the two elongate members 624 transmit a force F3 to the collar 640 and again due to the angle at which this force is applied the force F3 results in a force F4 being transmitted along the axis XX of the holder 630 to move the container in the direction of the nozzle to operate the pump. Giving the angles and geometry shown in Figure 26 an input force F1 of 20 Newton will result in a final output force F4 of 29.3 Newton. However, due to the change in angles that occurs as the levers 620, 621 are pressed together, the same input force F1 of 20N will result in a final output force F4 of 65.3N applied to the container 630 at the end of the supply trace as shown in Figure 27.
The elongated member construction material 624; 624a is selected so that bending occurs only after a minimum input force (ie, threshold) is employed.
Once this threshold force is exerted the bending of the elongated members 624; 624th occurs easily. This increase in mechanical proportion is useful in that it ensures that when a user applies a force to the levers 620, 621 a positive movement of the container occurs resulting in a short but powerful spray action. Operation of the fluid distributor device is as follows. Figure 29 shows the levers 620, 621 in a ready-to-use position in which the levers 620,621 are used to maintain the fluid discharge device 608 within the housing 609. In this position the end portions of the elongated members 624 rest on the detents 625. If required, the container 630 could be slidably engaged with one or more support structures (not shown) to assist with locating and retaining the fluid discharge device 608 in the housing 609. If a user then restrains the fluid distributor device 605 by the two levers 620, 621 then only light pressure is applied to the levers 620, 621, no fluid will be discharged and the user is able to maneuver the distributor nozzle 61 1 of the fluid distributor device 605 in the body orifice in which the fluid is required to be distributed. This is due to the presence of static friction between the pivot bolts 623 and the levers 620, 621 and also because the construction material selected for the elongated member 624 does not allow bending until a minimum threshold force is applied. If the user then tightens the two levers 620, 621 together with increasing force the threshold force will be exceeded and the interaction of the flexed elongate members 624 with the projections 625 will then cause a force to be transmuted to the collar 640 and the container 630 will move quickly towards the nozzle 61 1. During this part of the operation the elongate members are subjected to elastic bending as the rofasional movement of the levers 620, 621 causes the projections 625 on each lever 620, 621 to move closely. Due to the boundary between the end of the supply tube 631 and the annular boundary 617, movement of the supply tube 631 in the same direction is not possible. The effect of this is to cause the holder 630 to move relative to the supply tube 631 causing the supply tube 631 to push the plunger into the pump sleeve thus moving the pump piston in the cylinder. This causes the fluid to be expelled from the cylinder in the supply tube 631. The forced fluid in the supply tube 616 is then transferred into the orifice 615 from where it is ejected as a fine spray into the body orifice.
In the release of the pressure applied to levers 620, 621 the supply tube 631 is driven out of the pump casing by the inner return spring and by the nafural reaction of the elongated members to return to its strong shape and causes the fluid to be drawn from the collection tube to fill the cylinder . The actuation procedure can then be repeated until all the fluid in the container has been used. However, only one or two doses of fluid are normally administered at a time. When the container is emptied a new fluid discharge device 608 is loaded into the housing 609 thus restoring the fluid dispensing device 605 in a usable condition. Figures 30 to 40 show another fluid dispensing device 705 suitable for spraying a fluid in a nasal cavity of a human user that is in accordance with the present invention. The fluid distributor device 705 comprises a plastic housing 709 (e.g., of ABS), a nozzle 71 1 for insertion into the nasal cavity into an upper periphery of the housing 709 and a fluid discharge device 708 housed within the housing 709 for reciprocal frascating along its longitudinal axis X-X. As shown in Figures 30 to 34, when the fluid discharge device 708 is received in the housing 709, its longitudinal axis X-X is in line with the nozzle 71 1. The outer surface, or a portion of the outer surface, of the nozzle 71 1 can be made from a smooth plastic material to the surface. However, in this embodiment the nozzle 71 1 is made of polypropylene (PP). The fluid discharge device 708 comprises a container 730, for storing sufficient fluid so that multiple metered doses thereof are distributed, and a compression pump 729 mounted on the container 730. The container 730 is made of a translucent plastic material or Transparent, although it will appear that it could be made of other translucent or transparent materials, such as glass. The pump 729 has a suction inlet 761, in the form of a deep tube, located within the container 730 and a discharge outlet 763, in the form of a pump rod, for transferring fluid from the pump 729 to the nozzle 71 1 . The housing 709 is provided with a window 750 through which the fluid level in the container 730 can be verified. Pivotally mounted to the housing is a means operable by the finger 720 to apply a force to the container 730 in a direction that is transverse to the longitudinal axis X-X. This transverse force moves the container 730 towards the nozzle 71 1 along the longitudinal axis XX to operate the pump 729. The means operable by the finger is in the form of a lever 720 (for example, of ABS) connected in a pivotal manner. at its lower end to the housing 709 and installed to press into the container 730 to drive the holder 730 toward the nozzle 71 1 when the lever 720 is rotated to the side by a finger or thumb of a user. A protective end cap 707 is provided for protection of the nozzle 71 1. The first and second drag 749a, 749b project from the protective end cap 707 to be received into properly insulated channels 751 a, 751 b provided from the housing 709 to allow secure attachment of the end cap 707 to the housing 709. When The first drag 749a is also received with lever movement 720 such as to prevent the actuation (ie, to ensure movement) of the lever 720 when the end face 707 and trailers 749a, 749b are in drag (i.e. , in the position covered by mouthpiece). The end cap 707 also has a profusion stop 760 having a final, resilient, convex 761 shape installed for sealing clutch with the dispensing orifice 715 of the nozzle 71 1 to provide an essentially air tight seal to the nozzle orifice 715 to prevent drainage of fluid back when retainer 760 is in its drag. The final lid is suitably made of the same material as the housing, for example, a plastic material, suitably ABS. As will be understood by reference to Figures 32, 34 and 36A, the lever 720 has a pair of peaks or protuberances 721 each having a cam surface 722 installed for interaction with one of a pair of follower surfaces 792 provided in a collar 790 (eg, acetal) fixed around the neck of the container 730. It will be appreciated that a force at the sides (i.e., substantially transverse to the longitudinal axis XX of the fluid discharge device 708) applied to the lever 720 results in the follower surfaces of cam 792 mounting the cam surfaces 722 thus resulting in upward movement (ie, along the longitudinal axis XX) of the fluid discharge device 708. In more detail, the peaks 721 are located at the upper end of the lever 720 on opposite sides thereof. In plan view, the upper end of the lever 720 has a U-shaped cross section, as shown in Figure 36A. The peaks 721 mount opposite sides of the fluid discharge device 708 for cooperation with the follower cam surfaces 792 diametrically opposed to the collar 790. Note that the fluid distributor device 705 only has a drive lever 720, the use of a pair of peaks 721 improves the ability of the lever 720 to raise the fluid discharge device 708 upwards along its longitudinal axis XX. Each cam surface 722 of the lever 720 has a variable mechanical ratio installed so that until a predetermined force is applied to the lever 720, no significant force is transferred to the container 730. In more detail, each cam surface 722 has a engagement portion 723a leaning at a first angle to the longitudinal axis XX of the fluid discharge device 708 and a driving portion 723b inclined to the longitudinal axis XX at a second angle that is greater than the first angle. The first angle should not be less than about 20 °, and suitably it is in the range of about 20-35 °, more appropriately about 20-26 °, still more appropriately approx. 22-26 °. The second angle may be in the range of approximately 40-60 °, suitably approx. 40-50 °, more appropriately approx. Four. Five. Therefore, when an inward force is initially applied to the lever 720 it is applied substantially normalistically to the longitudinal axis XX of the fluid discharge device 708 and virtually no force becomes a force along the longitudinal axis XX of the fluid discharge device 708 and thus the static friction between engagement portions 723a of peaks 721 and follower cam surfaces 792 is sufficient to keep lever 720 fixed effectively. However, when a predetermined load is applied to the lever 720 the static friction is exceeded and the follower cam surfaces 792 remain in engagement portions 723a. When the follower cam surfaces 792 reach the end of engagement portions 723a, the increase in inclination of the cam surfaces to the longitudinal axis XX in combination with the magnitude of the force being applied ensures that the follower cam surfaces 790 slide from Suddenly rapidly along the drive portions 723b causing the container 730 to move rapidly towards the nozzle 71 1 to drive the compression pump. This ensures that the pump is operated only when sufficient force is applied to produce an effective spray from nozzle 71 1. Referring to Figure 39, it will be noted that engagement portions 723a are flat sections of cam surfaces 722, while drive portions 723b are arcuate. More specifically, the drive portions 723b have a short, round transition section 723c contiguous with the associated engagement portion 723a. The transition sections 723c have a radius of curvature R1 which is greater than the radius of curvature R2 of the remainder of the actuation portion 723b, such radius R2 is constant over the length of the remainder of the actuation portion 723b. The transition portions 723c flattens the transfer of the follower cam surfaces 729 from the engagement portions 723a of the cam surfaces 722 to the drive portions 723b. They also reduce the degassing of cam surfaces 722. R1 in this mode is approximately 3mm, while R2 is approximately 25mm. However, other radios could be used, as will be appreciated by the person skilled in the art Referring to Figure 32The cam follower surfaces 792 are rounded edges of opposite way diaméfrica recorded 793 in the collar 790. This makes plásíico taken of the follower cam surfaces 792 on the cam surfaces 722 easier, and also reduces wear the respective surfaces. As shown in Figures 34 and 39, the peaks 721 have a tip that forms a cradle 724 for the engravings 793 on the collar 790 of the fluid discharge device 708 to rest on them. The cradles 724 have a support surface 724a extending transversely to the longitudinal axis X-X in which the engravings 793 can be supported. The cradles 724 act as a backup stopper for the fluid discharge device 708 so far to prevent the fluid discharge device 708 from moving down past the point where the cradles 724 engage the engravings 793. As it will be seen from Figure 34, this ensures that the follower cam surfaces 792 align with the engagement portion 723a of the cam surfaces 722. Note that the lever 720 turns inward, it will be appreciated that as the lever 720 rotates inwardly the inclined angle that the flat engagement portions 723a make with the longitudinal axis XX becomes smaller (stepped) thus increasing the resistance of the fluid discharge device 708 to rising upwards. However, the arcuate nature of the driving portions 723b, in particular that parge after the transition section 723c, is such that the inclined angle it makes with the longitudinal axis XX remains the same, or substantially equal, as the lever 720 turns inward. More specifically, it is considered that as the lever 720 pivots into the point section portion accionamienío 723b feniendo the radius of curvature R2 which is in confacto with the cam follower surface 792 upward the cam surface 722. The angle that a tangent to this changing contact point makes with the longitudinal axis XX remains the same, or substantially the same, as the lever 720 rotates downwardly to cause the fluid discharge device 708 to spray a metered dose of the fluid product. of the nozzle 71 1. This feature means that the resistance to inward movement of the lever 720 never increases after the concomitant characteristics have been overcome, as would be the case if the actuating portion 723b were a flat surface since its angle to the longitudinal axis XX would then increase as the lever 720 rotates inwardly. The aforementioned characteristics of the cam profile mean that the operator receives uniform tactile feedback from the device 705 when the lever 720 is operated to cause the fluid discharge device 708 to spray a metered dose of the fluid product from the nozzle 71 1. In order to utilize the fluid delivery device 705 a user must first remove the protective layer 707 by disassembling the nozzle orifice 715 to remove the retaining end 760 therefrom. The user then holds the fluid distributor device 705 and places a thumb and / or finger on the lever 720. By stipulating that only a light pressure is applied to the lever 720 no fluid will be discharged and the user is able to maneuver the dispensing nozzle 71 1 of the fluid delivery device 705 in one of its nasal cavities so that the fluid is capable of being distributed in the nasal cavity. If the user then squeezes the lever 720 toward adeníro with increasing force the threshold force defined by the interaction of the follower cam surfaces 792 with lots of engagement 723a of the cam surfaces 722 is overcome resulting in the container 730 moving quickly the nozzle 71 1 to drive the pump 729 and dispense fluid into the distribution port 715. In the release of the pressure applied to the lever 720 the pump is reset by its internal return resorie. further, the lever 720 has a leaf spring 765 (Figure 30) which acts with an inner wall of the housing 767 to bias the lever 720 to its rest position shown in Figures 29 to 32 and 34. The driving procedure can then be repeated until all the fluid in the container 730 has been used. However, only one or two doses of fluid are normally administered at one time. Referring to Figures 34 and 38, to counteract the lathe force that the lever 720 applies to the fluid discharge device 708, and to guide the axial displacement of the fluid discharge device 708 in response to the operation lever, the collar 790 has a pair of diametrically opposed paths 769 that are insulated parallel to the longitudinal axis XX. These tracks 769 are provided by the engravings 793. Each track 769 has a funnel shape at its upper end for self-guiding the tracks 769 over axially extendable, complementary passages 767, present on the inner surface of the housing 709, when the fluid discharge 708 is inserted into the housing 709 through a (lower) opening 771 at its lower end, such lower opening 771 is subsequently closed with a cover 772. It will also be appreciated that the track-passing mechanism places the collar 790 in the angular orientation corrected about the longitudinal axis XX so that the follower cam surfaces 792 face the cam surfaces 722. In use, the tracks 769 go in the passages 767 when the lever 720 exceeds the threshold force provided by the engagement portions 723a of the cam surfaces 722. As will be appreciated, the cooperation of the 769 tracks with the 767 passages prevents rotation. of the collar 790 in the housing 709. In addition to the tracks 769, the collar also has a cover 773 for the pump rod 763 which forms a sliding fit in a post hollow post post 775 of the nozzle 71 1 in which a passage Nozzle outlet 777 is formed. As shown in Figure 30, the pump rod 763 is located in an enlarged lower portion of the outlet passage 777 through an interference fit. It will therefore be appreciated that the pump rod 763 remains fixed in the housing 709 as the container 730 and the collar 790 are moved upward by the lever 720, ie, there is relative movement between the container-collar unit and the pump vásíago. In this manner, the pump 729 is compressed and a metered dose of the fluid produced is discharged through the pump rod 763 into the outlet passage 777 for ejection of the nozzle orifice 715 at the end of the outlet passage 777. The characteristic of engagement in the lever 720 ensures that the pumping force is sufficient for atomization of the fluid product from the nozzle 71 1. As shown in Figure 37, nozzle 71 1 in this embodiment is formed as a separate part of housing 709. This has advantages when the fluid product that is distributed is a medicament because it isolates the only part of the device that enters. in contact with the medicine. Accordingly, the pharmaceutical performance test of the nozzle 71 1 can be conducted without the need of the housing 709. Thus, once the nozzle 71 1 is completed, the proof of this can begin while the development and design of the housing 709 continues. Therefore, there is no conservation in the development of the device, as would be the case if the nozzle 71 1 is formed integrally with the housing 709. Any change in the molding of the housing would require a retest of the nozzle 71 1 to confirm that the new molding had no adverse effect on the performance of the nozzle. Furthermore, having a separate nozzle 71 1 means that the housing 709 can be adapted for different markets and / or different products. As an example, the nozzle 71 1 could be a universal nozzle for a set of accommodations having different shapes, different colors, etc. An additional advantage of a separate nozzle 71 1 is that it can be more easily formed from a material other than housing 709, for example one that is more acceptable for insertion into a nasal cavity and / or to contact the fluid product, especially where there is a medication but that may be too costly to form the full accommodation of it. For this purpose, and as shown in Figure 30, the housing 709 has an (upper) opening 780 at its upper end through which the nozzle 71 1 is inserted. Referring to FIGS. 31, 35 and 37, the nozzle 71 1 has a projection 781 at its lower end which engages the inner hole of the upper opening 780 so that the tip of the nozzle 71 1 projects from the upper aperture 780. distance required for nasal use. As will be seen from Figures 31 and 35, the inner bore of the upper opening 780 is bounded by a collar 783 formed of a series of collar segments 785 spaced angularly about the longitudinal axis X-X. The collar segments 785 are bent over the nozzle projection 781 by a stamping tool to hold the nozzle boss 781 against the inner hole to fix the nozzle 71 1 in the top opening 780. To assist in the assembly of the dispensing device. fluid 705, the lever 720 is provided with means to enable it to be placed in an exterior position with respect to the housing 709, to allow the fluid discharge device to be inserted into the housing 709 through the lower opening 771 into its resting position shown in Figures 30, 32 and 34, and the interior position with respect to the housing 709 shown in Figures 30 to 32. Referring to Figures 36A, 36B and 40, a tab 801 is provided at the upper end of the lever 720. projecting above the upper edge 802 of the lever 720. The tab 801 projects from a resilient bridge element 803 formed by a cut 805 in the lever 720. The resilient bridge element 803 deflects the tab 801 to its extended position shown in Figures 36A, 36B and 40, but allows the tab 801 to be lowered so that it is flush with, or is below, the upper edge 802 of the lever. As will be understood from Figure 30, the lever 720 is mounted in a groove 807 formed in the side of the housing 709. The lever 720, which is formed separately from the housing 709, but of the same plastic material, is mounted to the housing at first inserting its lower end 809, which carries the leaf spring 765, through the slot 807 to be received in an axial channel 81 1. The lever 720 is now placed in its outer position with the tab 801 being brought against the edge of the slot 807 to prevent lever 720 from moving through slot 807 to its inward position, as shown schematically in Figure 40. When lever 720 is in its outward position, the fluid discharge device 708 is able to be inserted into the housing 709 through the lower housing opening 771 into its rest position because the lever 720, and its peaks 722 in particular, do not impede the loading of the discharge device. uido 708. After the fluid discharge device 708 has been loaded in its rest position, the lever 720 is moved to its inward position by lowering the tab 801 so as to clear the edge of the slot 707 and then push the lever 720 inwards to its position shown in Figure 31, for example. If the lever 720 is in its inward position before the fluid discharge device 708 is loaded into the housing 709, the fluid discharge device could not be charged into the housing 709 to its rest position, without damaging the lever 720 in any case. As shown in Figure 31, for example, once the lever 720 moves to its inward position, the tab 801 returns to its extended position and is brought against an interior surface of the housing 709 to hold the lever 720 in the inward position. In this aspect, the lever leaf spring 765 biases the lever 720 outwardly. In more detail, the lug 801 is brought against an inner surface of one of the channels 751 a in the housing 709 in which the lid trailers 749 a, 749 b are adjusted to hold the protective cap 707 releasably in the housing 709 As shown in Figure 31, the eraser 749a received on channel 751 a is located in front of lug 801. It is therefore stipulated that the lever 720 is prevented from moving inwardly when the lid 707 is in its drag, to drive the fluid dispensing device 705, by the drag 749a blocking the inward movement of the lever tab 801. Those parts of the fluid dissipative device 705 made of a plastic material are formed by a molding process. In accordance with the present invention, the container 30, 130, 230, 330, 430, 530, 630, 730 of the fluid dispensing devices of Figures 1 to 40 contains a fluid medicament formulation having a viscosity of from 10 to 2000 mPa . to 25 ° C. The fluid medicament formulation is in one aspect, formulated as a solution formulation. In another aspect, the fluid medicament formulation is formulated as a suspension formulation comprising a suspension of medicated drug particles in an inert suspension formulation. Suspension Formulation A suspension formulation suitable for containment by the container herein has the following formulation: Pariculate medicament (MMD 3μm) 0.05-0.1% w / w Polysorbate 80 0.025% w / w Avicel RC591 1.5% w / w Dextrose 5.0% w / w BKC 0.015% op / p EDTA 0.015% w / w Water at 100% The pariculate drug is suitably either fluticasone propionate or 6a, 9a-difluoro-17 - [(2-furanylcarbonyl) oxy ] -1 1 ß-hydroxy-16a-methyl-3-oxo-androsla-1,4-diene-17β-carbothioic acid S-fluoromethyl ester. The viscosity of the above suspension formulation is approximately 25 mPa.s. The suspension formulation is prepared following the following procedure: Part A 1. Dissolve dextrose in purified water 2. Dissolve EDTA in dextrose solution 3. Add Avicel RC591 while stirring 4. Allow the suspension to hydrate Part B (separately) 1 . Dissolve Polysorbate 80 in purified water at 50-60 ° C 2. Prepare the drug paste in Polysorbate solution 80. Part C 1. Combine the A4 suspension with B2 suspension and stir 2. Add the BKC solution in purified water and shake 3. Adjust the pH with 1 N HCl 4. Add purified water to the correct weight For use herein, the container 30, 130, 230, 330, 430, 530, 630 of the fluid distributing devices of Figures 1 to 29 is filled with the suspension formulation above the total amount suitable for 120 drives. The pre-compression pump of the container is adapted to distribute 50 or 100 μl per operation, preferably 50 μl. Solution Formulation A suitable solution formulation in the present has the following formulation: Particulate Drug (MMD 3μm) 0.05-0.1% w / w Polyethylene Glycol (PEG 400) 75% w / w NaCl 0.9% w / w EDTA Na 0.015 % p / p BKC 0.015% w / w Water a: 100% The particulate medicament is suitably either fluticasone propionate or 6a, 9a-difluoro-17a - [(2-furani! carbonyl) oxy] -1 1ß -hydroxy-16a-methyl-3-oxo-androsta-1,4-diene-17β-carbothioic acid S-fluoromethyl ester The viscosity of the above solution formulation is > 10 mPa.s. For use herein, the container 30, 130, 230, 330, 430, 530, 630 of the fluid dispensing devices of Figures 1 to 29 is filled with the solution formulation above the total amount suitable for 120 drives. The pre-compression pump of the container is adapted to distribute 50 or 100 μl per drive, preferably 50 μl. It will be appreciated that although the invention has been described with respect to several specific embodiments there are many alternative combinations and facilities that could be used. The primary object of the invention is to provide a fluid dispensing device that is operable by one or more means operable by the finger (eg levers) by applying a force to a container with respect to a longitudinal axis of the container and including some means of pre-loading to prevent the container from moving significantly until the force applied to it reaches a predetermined threshold amount known to produce a dew * of reliable quality. The administration of medication can be indicated by the rationing of acute, chronic, mild, moderate or severe synomies or for prophylactic use. It will be appreciated that the precise dose administered will depend on the age and condition of the patient, the particular medication used and the frequency of administration and will ultimately be at the discretion of the attending physician. The modalities in which drug combinations are used are included. The present dispensing device is suitable for distributing formulations of fluid medicament for the delivery of inflammatory and / or allergic conditions of the nasal cavities such as rhinitis, for example, temporal or perennial rhinitis as well as other local inflammatory conditions such as asthma, CODP and dermatiíis. A suitable dosing regimen would be for the patient to slowly inhale through the nose subsequent to the nasal cavity being cleared. During inhalation the formulation would be applied to a nasal cavity while the voice is manually compressed. This procedure would be repeated then for the other nasal cavity. Typically, one or two inhalations per nasal cavity would be administered by the lower procedure up to three times each day, ideally once a day. Each dose, for example, can provide 5 μg, 50 μg, 100 μg, 200 μg or 250 μg of aclive medication. The precise dose is either known or easily accepted by those experts in maigery. Viscosity measurement test method A suitable method for measuring viscosity has the following procedure: Instrumentation TA Instruments Advanced Rheometer AR500 TA Instruments Electroconic Box Techne Tempeiie Junior TE-8J Water Bath System Computer (Compaq Pentium 4) Material Standard Acrylic Parallel Plate (60 mm) (Acrylic 5660, 6 cm Flat plate) Procedure The analysis is divided into two parts: (1) Sample analysis (using the AR Instrument Conírol Software) (2) Data analysis (using the TA Data Analysis Software) Load the AR Instrument Control Software. Join the geometry above the rheometer drive shaft. Set the temperature to 25 ° C Conduct rotational trace Lead Zero Space Load the Flow Procedure Establishments as set forth below: Software and Insírumenío Software Installations Geometry: Standard Acrylic Parallel Plate (80 mm) Space: 250 micrometers Flow Procedure Establishments (A) Conditioning stage Establishments: (i) Initial temperature = 25 degrees Celcius (Wait for the correct temperature) (ii) Perform pre-cut Shear Stress = 20 Pa Duration = 1 minute (iii) Performance Balance Duration = 10 seconds ( B) Continuous Ramp Stage 1 (i) Test Type = Continuous ramp (ii) Test Establishments: Ramp = Cut-off tension (Pa) from 0.2358 Pa to 20 Pa Duration = 1 minute Mode = Linear (iii) Sample points = 12 (iv) Other establishments: Temperature = 25 degrees Celsius (C) Post-experimental stage (i) Stability Sets the temperature = 25 degrees Celsius Aufo save file re (A) Sample analysis Using the AR Instrument Confrol Software, test the samples in triplicate following the steps as detailed below. (i) Invert the sample gently five times to ensure mixing without producing air bubbles and then load approximately 1.5 ml of sample onto the center of the Peltier plate. (ii) Lower the geometry of the drive shaft to close the space between the geometry and the Peltier plate below 250 micrometers. Carefully remove the excess suspension that comes out of the plate, (iii) Press the 'run' button and then record all the information of the required sample in the software. Start the analysis (iv) At the end of the test run, raise the geometry. Clean the Peltier plate and geometry using tissue and adequate solvent, typically methanol. (v) Repeat step (i) to (v) with the next sample. (B) Data Analysis Load the Software TA Data Analysis. Load the required results file For the thixo-pyropic suspension, conduct the data analysis using the Herschel-Bulklev model to adjust the flow and viscosity curves. Key in the required independent values (ie, shear rate = 250 1 / sec) and the software will calculate dependencies (ie, viscosities at 250 1 / sec) using the model in addition to indefinite viscosity, production tension and velocity index. Record the following values as they are generated by the software. (a) Viscosity (undefined value as derived from the Herschel-Bulkley model) (b) Production voltage (c) speed index (d) Viscosity at 250 1 / sec Note: This procedure is conducted at 25 ° C Noia: Voltage cut vs. cut tension profile = flow velocity Viscosity profile = viscosity curve The claims of this application may be directed to any characteristic or combination of features described herein. They may take the form of product, method or use claims and may include, by way of example and without limitation, one or more of the following claims.

Claims (2)

  1. CLAIMS 1. A fluid dispensing device for spraying a fluid in a body cavity comprising a housing, a nozzle for insertion into a body cavity, a fluid discharge device movably received within the housing, the fluid discharge device having a longitudinal axis and comprising a container containing a fluid medication formulation to be dispensed and a compression pump having a suction inlet located within the container and a discharge tube extending along the longitudinal axis to transfer fluid from the pump to the nozzle and operable medium by the movable finger with respect to the longitudinal axis of the fluid discharge device to apply a force to the container to move the container along the longitudinal axis toward the nozzle to drive the compression pump wherein a pre-charge means is provided. to prevent the drive of the compression pump to what A predetermined force is applied to the means operable by the finger, and in the present said fluid medicament formulation has a viscosity of from 10 to 2000 mPa.s at 25 ° C.
  2. 2. A fluid dispensing device according to claim 1, characterized in that the means operable by the finger comprises at least one lever pivotally connected to a part of the housing and installed to act on the container to drive the container towards the nozzle when the or each lever is moved by a user. A fluid distributor device according to claim 2, characterized in that there are two opposite levers, each of which is pivotally connected to a part of the housing and is installed to act on the container to propel the container towards the nozzle when the two levers are pressed together by a user. A fluid dispensing device according to claim 1, characterized in that the means operable by the finger comprises at least one lever for applying a force to a driving means used to move the container towards the nozzle to drive the pump. A fluid distributor device according to claim 4, characterized in that the or each lever is supported pivotally at a lower end inside the housing and the actuating means is connected to a neck of the container. A fluid distributor device according to claim 5, characterized in that there are two opposed levers, each of which is pivotally supported near a lower end of the housing and is installed to act on the actuating means to drive the container towards the nozzle when the two levers are pressed together by a user. A fluid dispensing device according to claim 1, characterized in that the means operable by the finger comprises at least one lever slidably supported within the housing to apply a force to the container to move the container towards the nozzle and to drive the pump. compression. A fluid dispensing device according to any of claims 1 to 7, characterized in that the pre-loading means is interposed between the means operable by the finger and the container. A fluid dispensing device according to claim 8, characterized in that the pre-loading means comprises a passage formed in the container to be mounted by the means operable by the finger before the compression pump can be operated where the passage it is mounted when the predetermined force is applied to the means operable by the finger. A fluid dissipating device according to claim 8, characterized in that the pre-loading means comprises a passage formed in the means operable by the finger to be mounted by the container before the compression pump can be operated where the passage it is mounted when the predetermined force is applied to the means operable by the finger. eleven . A fluid dispensing device according to claim 8, characterized in that the pre-loading means comprises at least one stop formed in one of the container or the means operable by the finger and a gap formed in the other of the container or the means operable by the finger where the or each stop is capable to be dismantled from the gap with which it is engaged when the predetermined force is applied to the means operable by the finger. 12. A fluid dispensing device according to any of claims 1 to 7, characterized in that the pre-loading means is interposed between the housing and the container. A fluid dispensing device according to claim 12, characterized in that the pre-loading means comprises one or more detents formed in the clutch container with part of the housing, the or all detentions disengaging from the housing when the predetermined force is applies to the medium operable by the finger to allow the compression pump to be driven. 14. A fluid dispensing device according to claim 1, characterized in that the pre-loading means comprises one or more stops formed in the housing for clutch with the container, the or all stops disengaging from the container when the predetermined force is applied. applies to the medium operable by the finger to allow the compression pump to be driven. 5. A fluid dispensing device according to claim 1, characterized in that the pre-loading means is interposed between the container and the discharge tube. 16. A fluid distributor device according to claim 15, characterized in that the pre-loading means comprises a passage formed in the discharge tube and at least one latch member attached to the container, the installation being such that, when the predetermined force it is applied to the means operable by the finger, the or each bolt member is capable of mounting the step to allow the compression pump to be driven. 17. A fluid dispensing device as claimed, characterized in that the pre-loading means comprises a gap formed in the discharge tube and at least one latch member attached to the container, the installation being such that, when the predetermined force is applied to the means operable by the finger, the or each latch member is capable of being dismounted from the gap to allow the compression pump to be driven. 18. A fluid dispensing device according to any of claims 1 to 7, characterized in that the pre-loading means is interposed between the housing and the means operable by the finger. 19. A fluid dispensing device according to claim 18, characterized in that the pre-loading means comprises at least one stop formed in the clutch housing with the means operable by the finger, the or all the stops disengaging from the means operable by the finger when the predetermined force is applied to the means operable by the finger to allow the compression pump to be driven. 20. A fluid distributor device according to claim 18, characterized in that the pre-loading means comprises at least one stop formed in the means operable by the clutch finger with part of the housing, the or all stops disengaging from the housing when the The predetermined force is applied to the means operable by the finger to allow the compression pump to be actuated. twenty-one . A fluid dissipating device according to any of claims 4 to 6, characterized in that the pre-loading means is interposed between the actuating means and the housing. 22. A fluid distributor device according to claim 21, characterized in that the pre-loading means comprises at least one stop formed in part of the clutch actuating means with part of the housing, the or all detentions disengaging from the housing when the force Default is applied to the operable medium by the finger to allow the compression pump to be driven. 23. A fluid dispensing device according to claim 21, characterized in that the pre-loading means comprises at least one stop formed in part of the housing each stop being installed for clutch with a complementary recess formed in part of the actuating means, each stop disengaging from its respective recess when the predetermined force is applied to the recess. means operable by the finger to allow the compression pump to be driven. 24. A fluid dispensing device according to any of claims 4 to 6, characterized in that the pre-loading means is interposed between the operable medium by the finger and the respective driving means. 25. A fluid distributor device according to claim 24, characterized in that the pre-loading means comprises at least one stop formed in each clutch lever with a respective recess formed in part of the actuating means, each stop disengaging from its respective recess. Complementary when the predetermined force is applied to the lever to allow the compression pump to be driven. 26. A fluid distributor device according to claim 24, characterized in that the pre-loading means comprises at least one stop formed in each clutch actuating means with a recess formed in a means operable by the respective finger, each stop disengaging from its respective complementary recess when the predetermined force is applied to the means operable by the finger to allow the compression pump to be driven. 27. A fluid dispensing device according to claim 24, characterized in that the pre-loading means defines a variable mechanical proportion so that until the predetermined force is applied to the or each lever, no significant force is transferred to the container as required. length of the longitudinal axis. 28. A fluid dispensing device according to claim 27, wherein said variable mechanical ratio is defined by the interaction profile of a surface of the operable medium by the finger with a follower element provided to the holder or an adjustment provided thereto. 29. A fluid dissipating device according to claim 28, characterized in that said adjustment comprises a collar. 30. A fluid dispensing device according to any of claims 27 to 29, characterized in that the variable mechanical ratio has a two-step profile comprising an initial high gradient profile and a subsequent low gradient profile. 31 A fluid distributor device according to claim 30, characterized in that the gradient profiles, high and low, are both linear. 32. A fluid distributor device according to claim 30, characterized in that the gradient profiles, high and low, are both curved and have a flat break point between them. 33. A fluid dispensing device according to claim 32, characterized in that the gradient profiles, high and low, have circular part shapes. 34. A fluid dispensing device according to any of claims 12 to 17, characterized in that the means operable by the finger comprises a single lever and the pre-loading means further comprises a spring interposed between the lever and the container, the spring being used to push the container towards the nozzle to drive the compression pump. 35. A fluid dispensing device according to claim 34, characterized in that the spring is compressed by movement of the lever until the predetermined force is applied, at that point the means used to prevent the actuation of the compression pump is overcome by the force applied to the container by the spring and the container moves quickly towards the nozzle to drive the compression pump. 36. A fluid dispensing device according to any of claims 1 to 35 further comprising a force modifying means for modifying the force applied to the container by the means operable by the finger. 37. A fluid dispensing device according to claim 36, characterized in that said force modifying means amplifies the force applied to the container by the means operable by the finger. 38. A fluid dispensing device according to claim 37, characterized in that the amplification is provided in a uniform manner. 39. A fluid dispensing device according to claim 38, characterized in that the degree of amplification is from 1.5 to 10. 40. A fluid distributing device according to any of claims 36 to 39, characterized in that the force modifying means is integral with the medium operable by the finger. 41 A fluid dispensing device according to any of claims 36 to 39, characterized in that the force modifying means is located between the means operable by the finger and the container. 42. A fluid dispensing device according to any of claims 36 to 41, characterized in that the force modifying means comprises a lever, cam or screw element. 43. A fluid dispensing device according to any of claims 36 to 42, characterized in that the force modifying means acts once the predetermined force has been applied to the means operable by the finger. 44. A fluid dispensing device according to claim 43, characterized in that the force modifying means acts so that once the predefined force has been applied to the finger-operable means the modified force applied to the container is relatively consis- tent. 45. A fluid dissipating device according to claim 43, characterized in that the force modifying means acts so that once the predetermined force has been applied to the finger operable means the modified force applied to the container increases on a relatively constant basis. . 46. A fluid dispensing device according to any of claims 36 to 45, characterized in that the force modifying means further comprises a stop element. 47. A fluid dispensing device according to any of claims 1 to 46, characterized in that said fluid medicament formulation has a viscosity of from 20 to 1000 mPa.s, preferably from 50 to 1000 mPa.s at 25 ° C. 48. A fluid dispensing device according to claim 47, characterized in that said fluid medicament formulation is in the form of a solution formulation. 49. A fluid dispensing device according to claim 47, characterized in that said fluid medicament formulation is in the form of a suspension formulation comprising a suspension of active medicament particles in an inert suspension formulation. 50. A fluid dispensing device according to any of claims 47 to 49, characterized in that the fluid medicament formulation comprises an anti-inflammatory drug compound. 51 A fluid dispensing device according to claim 50, characterized in that said drug compound is a glucocorticoid compound. 52. A fluid dispensing device according to claim 51, characterized in that said glycocorticoid compound is selected from the group consisting of 6a, 9a-difluoro-17a- (1 -oxopropoxy) -1 1ß-hydroxy-16a-methyl-3 -oxo-androsta-1, 4- diene-17ß-carbothioic acid S-fluoromethyl ester; 6a, 9a-difiuoro-17a- [(2-furanylcarbonyl) oxy] -1 1 -hydroxy-16a-methyl-3-oxo-androsia-1, 4-diene-17β-carbothioic acid S-fluoromethyl ester; and 6a, 9a-difluoro-1 1-β-hydroxy-16a-methyl-17a - [(4-meityl-1,3-thiazole-5-carbonyl) oxy] -3-oxo-androsta-1,4-diene 17ß-carbothioic acid S-fluoromethyl ester. 53. A fluid delivery device according to claim 50, characterized in that said drug compound is selected from the group consisting of PDE4 inhibitors, leukotriene ani anagonists, NOS inhibitors, tripiase and elasphasa inhibitors, beta-2 integrin ani anagonists and beta-2 integrin agonists. adenosine 2a. 54. Equipment of paríes comprising (a) a housing assembly for reversible reception of a fluid discharge device for spraying a fluid in a body cavity, said fluid discharging device having a longitudinal axis and comprising a container for containing a formulation of drug suspension to be dispensed and a compression pump having a suction inlet located within the container and a discharge tube extending along the longitudinal axis to transfer fluid from the pump to the nozzle, the housing assembly comprising a housing, a nozzle for insertion into a body cavity and operable means by the movable finger with respect to the longitudinal axis of the fluid discharge device to apply a force to the holder to move the holder along the longitudinal axis toward the nozzle to drive the pump compression where a pre-loading medium is provided to prevent go the drive of the compression pump until a predetermined force is applied to the means operable by the finger; and (b) a fluid discharge device having a longitudinal axis and comprising a container containing a fluid medication formulation to be dispensed and a compression pump having a suction inlet located in the container and a discharge tube extending along the length of the container. longitudinal axis to transfer fluid from the pump to the nozzle, characterized in that said fluid medicament formulation has a viscosity of from 10 to 2000 mPa.s. 55. A fluid dispensing device for spraying a fluid in a body cavity substantially as substantially described in the reference with reference to the accompanying drawings.
MXPA/A/2006/004970A 2003-11-03 2006-05-03 A fluid dispensing device MXPA06004970A (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GB0325629.4 2003-11-03
GB0405477.1 2004-03-11
GB0420539.9 2004-09-17

Publications (1)

Publication Number Publication Date
MXPA06004970A true MXPA06004970A (en) 2006-10-17

Family

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