Patent Grant
8678243
This application is filed pursuant to 35 U.S.C. §371 as a United States National Phase Application of International Application No. PCT/EP2008/056655 filed May 30, 2008, which claims priority from GB 0710315.3 filed May 30, 2007and GB 0723420.6 filed Nov. 29, 2007 in the United Kingdom.
The present application claims priority from UK patent application Nos. 0710315.3 and 0723420.6 respectively filed on 30 May 2007 and 29 Nov. 2007.
The present invention relates to a fluid dispenser, for example for a nasal spray, and is particularly, but not exclusively, concerned with a fluid dispenser for drug administration.
Prior art fluid dispensers, e.g. for dispensing fluids into a nasal cavity, are known from US-A-2005/0236434 and WO-A-2005/075103, the entire original disclosures of which (as well as their patent family members) are incorporated herein by way of reference. These dispensers comprise a fluid reservoir, an outlet and a pump for pumping fluid from the reservoir through the outlet. The outlet is provided in a nozzle, which nozzle may be shaped and sized for positioning in a nostril. As the dispensers are for dispensing a metered volume of the fluid, they further comprise a metering chamber which is selectively placed in fluid communication with the reservoir, through at least one metering chamber inlet, and the outlet. The pump reciprocates to move the metering chamber between an expanded state, in which the metering chamber has a first volume greater than the metered volume, and a contracted state. The dispensers further comprise a one-way valve between the metering chamber and the outlet which is biased to a ‘valve-closed’ position. When the metering chamber moves from its contracted state to its expanded state, the metering chamber and reservoir are placed in fluid communication through the at least one inlet and fluid is drawn from the reservoir into the metering chamber to fill the metering chamber with an excess volume of fluid. When the metering chamber moves from the expanded state towards the contracted state, there is an initial bleed phase in which the surplus volume of fluid in the metering chamber is pumped back into the reservoir through the at least one inlet to leave a metered volume of fluid in the metering chamber. In a final dispensing phase of movement of the metering chamber back to its contracted state, the metered volume of fluid in the metering chamber is pumped towards the one-way valve whereby the increasing pressure produced in the fluid causes the one-way valve to temporarily open to enable the metered volume to be pumped from the outlet.
Other fluid dispenser arrangements are disclosed in FIGS. 1 to 21 of WO-A-2007/138084.
An aim of the present invention is to provide a novel fluid dispenser and novel components for a fluid dispenser, which fluid dispenser optionally incorporates the pumping principle disclosed in US-A-2005/0236434 and WO-A-2005/075103.
A first aspect of the present invention provides a component for a fluid dispenser which defines a dosing chamber for a piston member to stroke in and an end adapted for engaging a fluid outlet of the fluid dispenser or a seal which overlies the fluid outlet to selectively close and open the fluid outlet or seal
The end may be in the form of a tip. The component may be an assembly of parts. A first such part may form the end. The first part may be a cap part
The component may be provided with a seal on its outer surface for forming a sliding sealing fit in the fluid dispenser. The seal may be of the lip-seal type. The seal may be presented by the first part of the component.
The dosing chamber may be a first chamber with the component defining a second chamber, a fluid pathway between the dosing and second chambers and having a valve to selectively open and close the fluid pathway.
A second aspect of the present invention provides a fluid dispenser for use with a fluid supply, the dispenser having a dosing chamber, a fluid outlet, and a piston member which is arranged to sealingly stroke in the dosing chamber (i) in a first direction for filling the dosing chamber with fluid from the supply, and (ii) in a second direction to dispense fluid from the chamber towards the fluid outlet, wherein the dosing chamber has first and second sections of different widths, the first section is narrower than the second section and located in the second direction relative to the second section, and the piston member is in constant sealingly contact with the second section as it strokes in the first and second directions, but only in sealing contact with the first section in a portion of the strokes in the first and second directions.
The piston member may be provided with a seal to sealingly contact with the first section. The seal may have an outer dimension which is no less than the width of the first section and less than the width of the second section.
The seal may form a one-way valve with the piston member. The seal may be of the lip-seal type. The seal may be located on an end of the piston member.
The piston member may be provided with a seal to sealingly contact the second section of the dosing chamber. The seal may be of the lip-seal type.
The piston member may be provided with a fluid conduit for communicating with the fluid supply and through which, in use, fluid is conveyed from the fluid supply into the dosing chamber when the piston member strokes in the first direction. The fluid supply may have an outlet positioned on the piston member to register with the second section of the dosing chamber.
The fluid dispenser may be adapted such that, in use, as the piston member strokes in the second direction fluid in the dosing chamber is bled from the dosing chamber (e.g. back to the fluid supply) until the piston member sealingly contacts the first section of the dosing chamber. The fluid may be bled back to the fluid supply via the fluid conduit in the piston member.
The fluid dispenser may comprise a valve between the dosing chamber and the fluid outlet which remains closed as the piston member strokes in the second direction before it comes into sealing contact with the first section. The valve may be formed in an opening in the first section.
The fluid dispenser may be adapted such that the fluid is bled in the first direction around the piston member or the seal which selectively contacts the first section.
The one-way valve may be adapted to open to enable fluid to pass into the first section of the dosing chamber as the piston member strokes in the first direction with the seal in sealing contact with the first section.
The one-way valve may be adapted to close when the piston member strokes in the second direction.
According to a third aspect of the invention there is provided a piston member for stroking in a dosing chamber of a fluid dispenser, the piston member having a seal mounted thereon to form a one-way valve, wherein the seal is not an O-ring.
According to a fourth aspect of the invention there is provided a fluid dispenser comprising a container for a fluid, a dosing chamber, a fluid outlet and a piston member arranged to stroke in the dosing chamber (i) in a first direction for filling the dosing chamber with fluid from the container, and (ii) in a second direction to dispense fluid from the chamber towards the fluid outlet, wherein the piston member is mounted to move in unison with the container.
The piston may be comprised in a cap structure mounted on the container. The cap structure may be a stopper inserted into an opening of the container.
The dosing chamber may be provided in a nozzle of the fluid dispenser in which the fluid outlet is formed.
The nozzle may be mounted on the container for relative movement therebetween, for instance to cause the piston member to stroke in the dosing chamber.
The nozzle may be mounted on the cap structure.
The nozzle may be shaped and sized for insertion into a nostril of a human being. Of course, it could be shaped for different applications, for instance insertion into different body cavities or topical application to other body areas.
The fluid dispenser may have a biasing mechanism to bias the piston member to a rest position in the dosing chamber. The rest position may be a retracted position of the piston member in the dosing chamber.
In another aspect of the invention there is provided a fluid dispenser having a container for a fluid, a nozzle mounted on the container for movement towards and away from the container, a piston member and dosing chamber, the piston member being comprised in the container or the nozzle and the dosing chamber being comprised in the other whereby relative movement of the nozzle and the container causes the piston member to stroke in the dosing chamber for filling and emptying of the dosing chamber, and wherein the fluid dispenser is adapted so that at rest the nozzle and container are separated at a first spacing, wherein for actuation of the fluid dispenser the nozzle and container are moved towards one another and then returned to the first spacing, and wherein the nozzle and container are separable to a second spacing, greater than the first spacing to improve protection of the fluid dispenser in the event of an impact event, e.g. dropping of the fluid dispenser.
A yet further aspect of the invention provides a fluid dispenser for use with a fluid supply, the dispenser having a fluid outlet, dosing chamber, a piston member arranged to reciprocate in the dosing chamber to selectively fill the dosing chamber with fluid from the fluid supply and pump fluid from the dosing chamber towards the fluid outlet, optionally a seal for sealing the fluid outlet which is movable from a normal closed state, in which the seal prevents fluid being dispensed through the fluid outlet, to an open state, in which the seal opens the fluid outlet for enabling dispensing therefrom, and a component movable between a normal first position, in which the member seals the fluid outlet or acts on the seal to locate the seal in the closed state, and a second position, which opens the fluid outlet or enables the seal to move to the open state, wherein the component comprises the dosing chamber.
In another aspect of the invention, there is provided a sealing arrangement for sealing a fluid outlet of a fluid dispenser comprising a seal member having a first face for sealing the fluid outlet, a second face in which is provided a recess, and a component which is sealingly slidably mountable in the recess for sliding movement relative to the seal member between an inward position and an outward position, wherein in the inward position the component causes the first face to be deflected outwardly and in the outward position the first face is able to return towards its original state.
The seal member may be made from a resilient material or other type of material which has shape memory; i.e. having the ability to return to an original shape.
Each aspect of the invention may also comprise any of the additional features of (i) the other aspects of the invention, or (ii) the exemplary embodiments described with reference to the accompanying Figures.
These and other aspects and features of the present invention will be understood from the exemplary embodiments which will now be described with reference to the accompanying Figures of drawings.
In the following description of non-limiting specific embodiments according to the present invention, any terms concerning the relative position, orientation, configuration, direction or movement of a given feature (e.g. “forward”, “anti-clockwise” etc.) relate only to the arrangement of that feature from the view point shown in the specific Figure or Figures to which the description refers. Moreover, these terms are not meant to be limiting on the arrangement for the invention, unless stated otherwise.
Furthermore, in the following description of exemplary fluid dispensers in accordance with the present invention, the fluid dispensers are for dispensing a liquid, and all references to “fluid” in relation to the description of these exemplary fluid dispensers should be read as meaning liquid. The liquid may contain a medicament, for example suspended or dissolved in the liquid.
The underlying principle of operation of the exemplary fluid dispensers is as described in US-A-2005/0236434 and WO-A-2005/075103 supra.
Like reference numerals are used to identify like features as between the various exemplary fluid dispensers for ease of reference.
Referring to
As shown in
The main housing 112 in this embodiment is injection moulded from polypropylene (PP), but other plastics materials could be used.
Referring to
The forward section 120a forms a metering chamber which meters a volume of the fluid for dispensement from the dispenser 110. The metered volume may be 50 microliters, but this is only illustrative as the fluid dispenser 110 can be arranged to dispense the desired metered volume.
Turning back to
The rear section 114b presents an open rear end 114d of the piston member 114. The rear section 114b is cup-shaped having an annular outer peripheral wall 114e which defines an internal cavity 114f having a mouth 114g which opens in the rear end 114d.
The forward section 114a is solid and presents the forward end 114h of the piston member 114. The forward section 114a comprises an annular flange 114i rearwardly of the forward end 114h.
The central section 114c connects to the forward and rear ends 114a, 114b and comprises an internal bore network 114j to place the rear section 120b of the dosing chamber 120 in fluid communication with a fluid supply 170 (in this particular embodiment a bottle, e.g. of glass or a plastics material—see
The piston member 114 is provided with a plurality of axially-oriented grooves 114r about the outer periphery. The grooves 114r extend rearwardly from a rear surface 114s of the annular flange 114i in the forward section 114a to an annular rib 114t on the central section 114c rearward of the forward openings 114q of the internal bore network 114j. The grooves 114r are arranged so that at least a portion of the forward openings 114q are within the grooves 114r.
A tip part 114u of the forward section 114a of the piston member 114, which extends forwardly from the flange 114i to the forward end 114h, has a triangular cross-sectional shape, with the apexes being rounded.
The piston member 114 in this embodiment is injection moulded from polypropylene (PP), but other functionally equivalent plastics materials could be used.
Referring to
The rear sealing element 128 is of the lip-seal type, being provided with resilient, annular sealing lips 128a, 128b at its forward and rear ends, respectively. The material of the rear sealing element 128 provides the sealing lips 128a, 128b with an inherent outwardly-directed bias. The sealing lips 128a, 128b have an outer diameter which is greater than the inner diameter of the rear dosing chamber section 120b, whereby the sealing lips 128a, 128b are compressed inwardly by the inner surface of the rear dosing chamber section 120b. As a result, the bias in the sealing lips 128a, 128b means they sealingly engage the inner surface of the rear dosing chamber section 120b.
The rear sealing element 128 further comprises a tubular body 128c from which the sealing lips 128a, 128b depend and which fits on the outer surface of the piston member central section 114c by engagement of an inner circumferential bead 128d of the rear sealing element 128 in a recessed portion 114w of the central section 114c of the piston member 114. The tubular body 128c has a length such that, when fitted on the piston member 114, it covers substantially the entire axial extent of the central section 114c of the piston member 114. It will further be seen from
Now referring additionally to
The forward sealing element 148 is also of the lip-seal type, but this time only being provided with a resilient, annular sealing lip 148a at its forward end. The outer diameter of the sealing lip 148a is less than the inner diameter of the rear dosing chamber section 120b, but greater than the inner diameter of the forward dosing chamber section 120a. Consequently, the forward sealing lip 148a is able to be biased into sealing engagement with the inner surface of the forward dosing chamber section 120a.
As will be observed, the forward sealing element 148 is slidably mounted on the forward section 114a of the piston member 114. In more detail, the forward sealing element 148 comprises a tubular body 148b, from which the sealing lip 148a depends, and provides an axial, open-ended bore 149 through the forward sealing element 148 in which the forward section 114a of the piston member 114 is slidably mounted. The bore 149 comprises forward and rear bore sections 149a, 149b and an enlarged, central chamber 149c. The forward and rear bore sections 149a, 149b respectively extend from the central chamber 149c to openings in the forward and rear ends 148c, 148d of the forward sealing element 148. The forward end 148c is provided with grooves 148g which intersect the forward bore opening therein. The central bore chamber 149c is provided with a pair of diametrically opposed windows 149f through the tubular body 148b.
The annular flange 114i of the piston member 114 is located inside of the central bore chamber 149c. The central bore chamber 149c has transversely-oriented forward and rear end walls 149d, 149e which selectively engage the annular flange 114i of the piston member 114 to delimit the sliding movement of the forward sealing element 148 on the piston member 114. Specifically, the forwardmost position of the forward sealing element 148 relative to the piston member 114 is delimited by the rear end wall 149e abutting the annular flange 114i (see e.g.
The sliding movement of the forward piston member section 114a in the forward sealing element bore 149 forms a one-way valve. The one-way valve is closed when the forward sealing element 148 is in its rearmost position relative to the piston member 114 and open as the forward sealing element 149 moves towards its forwardmost position relative to the piston member 114, as will be discussed in more detail hereinafter.
To this end, it will be understood that the annular flange 114i forms a fluid-tight seal against the forward end 149d of the central bore chamber 149c when the forward sealing element 148 is in its rearmost position.
In operation, as the piston member 114 strokes forwardly relative to the dosing chamber 120 (see e.g.
Once the piston member 114 reaches its forward position at the end of its forward stroke, as delimited by abutment of the forward end 148c of the forward sealing element 148 with a forward end wall 120c of the dosing chamber 120 (see
It will thus be appreciated that in an initial phase of the forward stroke of the piston member 114 in the dosing chamber 120, from its rest position towards its forward position, the piston member 114 moves forwardly relative to the forward sealing element 148 to (re)close the one-way valve.
The rear and forward sealing elements 128, 148 in this embodiment are injection moulded from low density polyethylene (LDPE), but other functionally equivalent plastics materials could be used.
A return, compression spring 118 is provided in the fluid dispenser 110 to bias the piston member 114 to its rearward (resting) position relative to the dosing chamber 120, which is shown in
Referring to
A plurality of apertures 165e are also formed in the forward end wall 165b, about the base of the sealing tip 160, to communicate with the internal chamber 165c. In this embodiment, there are three equi-angularly spaced apart apertures 165e, but alternatively there may be less or more in number than three apertures.
The inner circumferential side surface 165f of the internal chamber 165 is provided with a pair of circumferential beads 165g. The outer circumferential edge of the forward end wall 165b presents a resilient, annular sealing lip 165h.
In this embodiment, the cap 165 is formed from LDPE, but again other plastics materials could be used.
As shown in
As further shown in
As shown in
Turning back to
The valve element 191 in this embodiment is injection moulded from low density polyethylene (LDPE) or polypropylene (PP), but other functionally equivalent plastics materials could be used. The return spring 193 may be of metal (e.g. of stainless steel, such as of 304 or 316 grade) or a plastics material. The return spring 193 may have a return force of approximately 0.4N.
From
Referring also to
The stopper portion 176 has a roof 176c at its forward end extending radially inwardly from the outer skirt 176a to the inner skirt 176b. The inner skirt 176b encloses an internal cavity 176d which extends rearwardly from a opening 176e in the roof 176c. The cavity 176d has a floor 176f at its rear end from which upstands an elongate tubular projection 176g.
The tubular projection 176g has an open rear end 176h, a forward end wall 176i, an internal cavity 176j which extends forwardly from the open rear end 176h to the forward end wall 176i, and a forward opening 176k in the forward end wall 176i to place the internal cavities 176d, 176j in flow communication.
As shown in
The tubular projection 176g is secured against relative movement in the internal cavity 114f of the piston member 114 by the internal cavity 114f of the piston member 114 presenting a plurality of circumferential beads 114v on its inner circumferential surface to which clip or interlock circumferential beads 176s provided on the outer circumferential surface of the tubular projection 176g.
As further shown in
It will be seen from
The fluid dispenser 110 further comprises a cylindrical carrier member 195 which surrounds the tubular body 112a of the main housing 112. As shown in
As shown in
In normal use of the fluid dispenser 110, the carrier member 195 seats on the roof 176c of the stopper portion 176, both in the rest and fired positions of the fluid dispenser 110 to be discussed hereinafter. This normal position for the carrier member 195 is shown in
The carrier member 195 in this embodiment is also injection moulded from polypropylene (PP), but other plastics materials may be used.
Referring back to
The fluid dispenser 110 also comprises a tubular nozzle insert 197 surrounding the cap 165 mounted on the forward section 112h of the main housing 112.
The nozzle insert body 197a further comprises a second annular section 197j spaced rearwardly of the first annular section 197e and from which the legs 197g depend. The first and second annular sections 197e, 197j are joined together by a plurality of spaced-apart, resilient ribs 197k which are disposed on the outer circumference of the body 197a and extend on a diagonal path between the first and second annular sections 197e, 197j.
The second annular section 197j presents a pair of diametrically opposed, forwardly oriented, resilient tongues 197l. The tongues 197l are disposed between the ribs 197k.
On the forward face of the forward end wall 197c there is provided an annular lip 197m about the central aperture 197d. The forward end wall 197c is further provided with apertures 197n therethrough.
The nozzle insert 197 in this embodiment is injection moulded from polypropylene (PP), but could be made from other plastics materials, as will be appreciated by those skilled in the art.
An annular space formed between the nozzle insert 197 and the cap 165 defines a fluid dispensement chamber 146.
It will be seen from
The sealing member 154 is made from natural rubber or a thermoplastic elastomer (TPE), but other elastic materials may be used which have a ‘memory’ to return the sealing member 154 to its original state. The sealing member 154 may be made from ethylene propylene diene monomer (EPDM), for instance as an injection moulded EPDM component.
As shown in
As illustrated by
As further illustrated in
The nozzle section 116c encloses an internal cavity 116e having a rear open end 116f. A pair of T-shaped cut-outs 116g are provided on opposite sides of the internal cavity 116e. The longitudinal section 1161 defines a track in which the clips 195d of the carrier member 195 are clipped to secure the carrier member 195 to the nozzle 116 and to provide for sliding movement therebetween.
Moreover, in each corner 116n of the crossbar section 116v of the T-shaped cut-outs 116g is clipped one of the feet 197i of the nozzle insert 197 to fix the nozzle insert 197 in the internal cavity of the nozzle 116. These connections are best seen in
As shown in
To accelerate the fluid as it flows towards the central chamber 153a, the feed channels 153b are provided with a decreasing cross-sectional area in the fluid flow direction.
As shown in
In an alternative case, the width of the channels 153b may remain uniform throughout, and the channel depth decrease as the feed channels 153b approach the central chamber 153a. In this regard, the depth of the feed channels 153b may vary uniformly from 400 microns to 225 microns, for example.
The width and depth of the feed channels 153b may also both vary along their length whilst providing the decreasing cross-sectional area in the fluid flow direction. In this regard, the aspect (width:depth) ratio along the length of the feed channels 153b may be maintained constant.
Preferably, the feed channels 153b are of narrow width to inhibit their obstruction by the sealing member 154, e.g. as from creep of the sealing member material. Preferably, the feed channels 153b have a low aspect (width:depth) ratio; i.e. are narrow and deep, preferably with the width being less than the depth (e.g. of rectangular cross-section).
As will be understood from
However, as shown most clearly in
Moreover, the return spring 118 acts to bias the main housing 112 forwardly in the nozzle 116 whereby the sealing tip 160, on the cap 165 fixed on the forward section 112h of the main housing 112, pushes a central part of the forward face 154c of the sealing member 154 into the central chamber 153a of the swirl chamber 153 to sealingly close the passageway 153c to the fluid outlet 152. In this way, no fluid can enter or exit the fluid outlet 152, or more particularly the swirl chamber 153, until the sealing tip 160 releases the central part of the elastic sealing member 154, to be described in more detail hereinafter.
In a modification, the straight walls of the central chamber 153a of the swirl chamber 153 may be chamfered to facilitate pushing the central part of the sealing member 154 thereinto. This is shown in
The nozzle 116 in this embodiment is injection moulded from polypropylene (PP), but other plastics materials could be used.
To operate the fluid dispenser 110, it is first necessary to prime the fluid dispenser 110 to fill all the fluid pathways between the fluid outlet 152 and the fluid supply 170. To prime, the fluid dispenser 110 is operated in exactly the same manner as for later dispensing operations. As shown in
It will be appreciated that the relative movement of the nozzle 116 and the fluid supply 170 to effect priming and then dispensing from the dispenser 110 is actually relative movement between the nozzle 116 and the components assembled thereto (the “nozzle assembly”, including the nozzle insert 197, the cap 165 and the main housing 112) and the fluid supply 170 and the components assembled thereto (the “bottle assembly”, including the stopper portion 176 and piston member 114). The return spring 118 biases the nozzle assembly away from the bottle assembly and thus the piston member 114 to its rearward, rest position in the dosing chamber 120 in the main housing 112.
Each complete (reciprocal) cycle of the afore-mentioned sliding movement (a “pumping cycle”) between the nozzle 116 and the fluid supply 170 includes a phase which creates a negative pressure in the dosing chamber 120 which draws liquid from the fluid supply 170 up the supply tube 172 and this cycling continues until liquid fills up all the fluid pathways from the fluid supply 170 to the fluid outlet 152, as will be now described in more detail.
In more detail, the liquid flows forwardly through the supply tube 172, into the bore network 114j of the piston member 114 via the rear opening 114m thereof, and out of the forward openings 114q of the bore network 114j into the rear section 120b of the dosing chamber 120 via the axial grooves 114r in the outer periphery of the piston member 114 (see
As a result of the nozzle 116 and the fluid supply 170 respectively carrying the main housing 112 and the piston member 114, as described above, each reciprocal cycle of relative movement of the nozzle 116 and the fluid supply 170 causes the piston member 114 to stroke in corresponding reciprocating fashion inside the dosing chamber 120 defined by the main housing 112 from the rear (rest) position.
As the piston member 114 returns from its forward position to its resting, rear position, in the second half of each cycle, a negative pressure is created in the dosing chamber 120 to draw the liquid further forwardly. Moreover, the piston member 114 moves rearwardly relative to the forward sealing element 148 to open the one-way valve, as described hereinabove, and therefore allows the liquid to flow forwardly into the forward dosing chamber section 120a through the one-way valve (see
Specifically, as the annular flange 114i of the piston member 114 disengages from the forward end wall 149d of the central bore section 149c of the bore 149 in the forward sealing element 148, the liquid to the rear of the one-way valve is able to flow around the flange 114i of the piston member 114 via the windows 149f in the forward sealing element 148, over the tip part 114u of the piston member 114 and through the forward bore section 149a of the forward sealing element 148 into the forward section 120a of the dosing chamber 120.
After the dosing chamber 120 (including the forward section 120a) is filled with liquid by priming the fluid dispenser with enough pumping cycles (see
In more detail, in the forward stroke of the piston member 114 to its forward position in the dosing chamber 120, the valve mechanism 189 in the forward bore section 112f keeps the restricted bore section 112e shut until after the forward sealing element 148 comes into sealing engagement with the inner surface of the forward dosing chamber section 120a. This is because the biasing force of the valve return spring 193 is not overcome by the hydraulic pressure of the liquid produced on the initial (first) phase of the forward stroke of the piston member 114 prior to the forward sealing element 148 sliding into sealing engagement in the forward dosing chamber section 120a to sealingly separate the forward and rear dosing chamber sections 120a, 120b.
This first phase may be referred to as the “bleed phase” because it results in liquid being pumped rearwardly from the dosing chamber 120 back into the fluid supply 170 (i.e. bled) until the piston member 114 locates the forward sealing element 148 in the forward dosing chamber 120a (i.e. so there is no longer any flow therebetween, recalling that the one-way valve defined by the forward sealing element 148 on the piston member 114 is reclosed in the forward stroke of the piston 114). The bleed flow is aided by the provision of the at least one axial flute 120d in the step 120s of the dosing chamber 120.
Once the forward sealing element 148 is located in the forward dosing chamber 120a, the forward dosing chamber 120a, and the metered volume of liquid which fills it, is sealed. The flutes 120d no longer provide a fluid flow path into the forward dosing chamber section 120a, since the forward sealing element 148 is at, or forward of, the forward end of the flutes 120d and in sealing engagement with the inner wall of that chamber section 120a.
In the next (second) phase of the continuous forward stroke of the piston member 114, the piston member 114 increases the hydraulic pressure of the liquid in the forward dosing chamber section 120a as it moves relatively towards the forward end wall 120c of the forward dosing chamber section 120a presented by the annular shoulder 112d of the main housing 112. At a certain point in the second phase of the forward stoke of the piston member 114, which may be nearly instantaneous, the hydraulic pressure of the liquid in the forward dosing chamber section 120a is at a level which is greater than the biasing force in the return spring 193 of the valve mechanism 189, whereby the valve element 191 is forced out of sealing engagement with the restricted bore section 112e (which functions as a “valve seat”), as shown in
The valve mechanism 189 only opens in this final (third) phase, remaining closed at all other times.
The second and third phases can collectively be considered as a “dispensing phase”.
In an initial (first) phase of the return, rearward stroke of the piston member 114 in the dosing chamber 120, driven by the return spring 118, the piston member 114 not only moves rearwardly with respect to the dosing chamber 120, but also to the forward sealing element 148 so as to open the one-way valve, as discussed hereinabove. Moreover, a negative pressure (or vacuum) is generated in the headspace being formed in the forward dosing chamber section 120a in front of the rearwardly moving piston member 114.
This negative pressure draws more liquid out of the fluid supply 170 and through the open one-way valve into the forward dosing chamber section 120a until the forward sealing element 148 disengages from the forward dosing chamber 120a to enter the step 120s (see
In a final (second) phase of the rearward stroke of the piston member 114, the piston member 114 moves from an intermediate position, at which the forward sealing element 148 has just been disposed in the step 120s to its rearward position. In this final phase, the liquid is able to be drawn from the rear dosing chamber section 120b directly into the forward dosing chamber section 120a around the outside of the forward sealing element 148, in addition to via the open one-way valve. When the forward sealing element 148 is moving rearwardly in the step 120s, the liquid flows around it via the flutes 120d. Concomitantly, bleeding of the liquid from the forward dosing chamber section 120a to the rear dosing chamber section 120b is via the flutes 120d when the forward sealing element 148 is moving forwardly in the step 120s towards the forward section 120a.
At the end of the return, rearward stroke, the dosing chamber 120 is refilled with liquid. In other words, the volume between the forward lip seal 128a of the rear sealing element 128 and the forward end wall 120c of the dosing chamber 120 is filled. The return stroke may thus be referred to as the “filling phase”.
Thus, each cycle of movement of the piston member 114 in the dosing chamber 120, as effected by reciprocal movement between the nozzle assembly and the bottle assembly, comprises the bleeding, dispensing and filling phases.
In each subsequent cycle of movement of the piston member 114, the forward stroke results in another metered volume of the liquid being captured in the forward dosing chamber section 120a and then discharged through the restricted bore section 112e, while the rearward stroke results in liquid being drawn from the fluid supply 170 to refill the dosing chamber 120.
During priming, such subsequent pumping cycles continue until the liquid fills the fluid flow path from the dosing chamber 120 to the fluid outlet 152 (see
When liquid fills the fluid pathway from the fluid supply 170 to the fluid outlet 152, the forward stroke of the piston member 114 relative to the dosing chamber 120 in the next pumping cycle results in another metered volume of liquid being pumped through the restricted bore section 112e thereby pressurising the liquid pending downstream of the restricted bore section 112e. This pressure in the fluid dispensement chamber 146 results in rearward sliding movement of the cap 165 (and the main housing 112) in the nozzle insert 197 against the return force of the return spring 118 whereby the sealing tip 160 sealingly slides rearwardly in the sealing member 154. This is because the surface area of the sealing cap 165 bounding the fluid dispensement chamber 146 (and hence being acted upon by the pressurised fluid) is greater than that of the nozzle insert 197.
As a result, the elasticity of the sealing member 154 flattens the central part of the forward face 154c of the sealing member 154 back to its original state to open the central chamber 153a and passageway 153c of the swirl chamber 153 (see
The dynamic seal between the opposing longitudinal sides of the sealing tip 160 and the sealing member 154 prevents liquid under the hydraulic pressure entering the sealing member cavity 154e (
The return force of the return spring 118 moves the main housing 112 and sealing cap 165 back (forwardly) to its normal, rest position in the nozzle insert 197 once the return force is greater than the hydraulic pressure in the fluid dispensement chamber 146 so that the sealing tip 160 deflects the sealing member 154 to (re)close the fluid outlet 152.
The sealing member 154 thus protects the liquid inside the fluid dispenser 110 from contamination by contaminants outside of the dispenser 110 entering through the fluid outlet 152 as it only opens during dispensing (i.e. when the fluid dispenser 110 is fired).
The rearward stroke of the same pumping cycle draws liquid from the liquid supply 170 to refill the dosing chamber 120, ready for the next pump cycle.
The dispenser is now fully primed, and each pump cycle thereafter results in a constant metered volume of the liquid being pumped from the fluid outlet 152 until the fluid supply 170 is exhausted.
It will be appreciated that the fluid dispenser 110 configuration is such that there will be no, or substantially no drain-back of the liquid pending in the path between the dosing chamber 120 and the fluid outlet 152 as the restricted bore section 112e is sealed shut by the valve mechanism 189 except in the dispensing phase of the forward stroke. Thus, the need to re-prime the dispenser is avoided or substantially alleviated. Moreover, the tip seal arrangement, formed by the sealing member 154 and the sealing tip 160, and the valve mechanism 189 prevent or substantially prevent ambient air being drawn into the fluid dispenser 110 through the fluid outlet 152 by the negative pressure (e.g. vacuum) created in the dosing chamber 120 in the filling phase.
It is also notable that during priming of the fluid dispenser 110, air (and any other gas) in the headspace above the liquid is pumped out of the fluid outlet 152 by the same mechanism as described above for the liquid.
As described previously, the engagement of the forward end wall 165b of the cap 165 with the rear side of the end wall 197c of the nozzle insert 197 limits the length of the sealing tip 160 that is able to project through the nozzle insert 197 onto the rear face of the sealing member 154. In this way, the stress applied by the sealing tip 160 to the sealing member 154 is controlled and so too, therefore, is creep of the sealing member 154 over the lifetime of the dispenser 110. Consequently, in this arrangement the sealing member 154 will be less prone to creep into the swirl chamber feed channels 153b to create a permanent obstruction therein and to lose the elastic/shape memory properties upon which the sealing member 154 relies to open the fluid outlet 152 when the sealing tip 160 is moved rearwardly in use of the fluid dispenser 110, as described hereinabove.
Moreover, the above-described engagement of the sealing cap 165 and the nozzle insert 197 demarcates the forwardmost position of the main housing 112 in the nozzle 116, noting that the nozzle insert 197 is fixed in position in the nozzle 116 through engagement of the nozzle insert feet 197i in the T-shaped cut-outs 116g. This forwardmost position of the main housing 112 in the nozzle 116 is its normal, rest position as a result of the action of the return spring 118. The main housing 112 only moves rearwardly from this rest position when the fluid in the fluid dispensement chamber 146 is pressurised in the dispensing phase of the operational cycle of the fluid dispenser 110. This fixing of the rest position of the main housing 112 in the nozzle 116 ensures that the piston member 114 is able to abut the forward end wall 120c of the dosing chamber 120 in the dispensing phase for reliable metering from the dosing chamber 120, noting that if the main housing 112 was ‘floating’ in the nozzle 116 so as to be able to be moved further forwardly therein, the piston member 114 would be spaced rearwardly of the dosing chamber forward end wall 120c at the end of the forward stroke of the piston member 114, as demarked by engagement of the roof 176c of the stopper portion 176 with the rear end 116f of the nozzle 116.
It will also be appreciated that the inter-engagement of the sealing cap 165 with the nozzle insert 197 also prevents the piston member 114 being able to push the sealing tip 160 any farther into the sealing member 154 when the piston member 114 contacts the forward end wall 120c of the dosing chamber 120.
It will be appreciated that the fluid dispenser 110 is able to adopt the open position through the carrier member 195 being separate from the stopper portion 176.
There now follows descriptions of alternative sealing arrangements that could be used in the fluid dispenser 110, with like reference numerals being used to indicate like parts and features with the sealing arrangement in
In FIGS. 18 and 19A-B there is shown a first alternative tip seal arrangement that could be used in the fluid dispenser 110. In
In
In
In place of the elastic sealing member 154 there is provided an annular backing plate 254 (
A sealing pin 255 (
As shown in
It will therefore be appreciated that the return spring 118 acts on the main housing 112 to bias the sealing pin 255 into sealing engagement over the swirl chamber passageway 153c. Moreover, during the dispensing phase of the forward stroke of the piston member 114 in the dosing chamber 120, the hydraulic pressure produced in the fluid dispensement chamber 146 results in the cap 265 moving rearwardly against the return spring force, and in so doing moves the sealing pin 255 rearwardly so as to open the swirl chamber passageway 153c for release of the metered volume of liquid.
It will be observed that the sealing pin 255 is provided with forward and rear annular flanges 255c, 255d. The rear flange 255d delimits the insertion of the sealing pin 255 into the cap through-hole 265n. The forward flange 255c seals against the rear side of the backing plate 254.
It will further be observed that the valve element 191 of the valve mechanism 189 in the main housing 112 is provided with an abbreviated length to accommodate the sealing pin 255.
The sealing pin 255 in this embodiment is injection moulded from low density polyethylene (LDPE) or high density polyethylene (HDPE), but other functionally equivalent plastics materials could be used.
The modified cap 265 and modified nozzle insert 297 are made from the same materials are described for the corresponding parts in the fluid dispenser 110 of
The arrangement of
Referring now to the fluid dispenser 310 shown in
If air happens to be trapped in the forward section 420a of the dosing chamber 420, for instance in the annular space in the forward sealing element 448 behind the lip seal 448a, the lip seal 448a may stay in sliding sealing contact with the wall of the forward dosing chamber section 420a during the rearward, return stroke of the piston member 414 and no hydraulic lock results due to the presence of the afore-mentioned air. In other words, there is no deflection of the lip seal 448a. When the lip seal 448a passes into the step 420s, the fluid is then drawn by the pressure difference into the forward dosing section 420a, e.g. through the at least one axial flute 420d.
However, preferably no air, or substantially no air, is trapped in the dosing chamber forward section 420a so that the forward lip seal 448a acts as a one-way valve.
In the rest position of the dispenser 410, the forward lip seal 448a is in contact with that section of the dosing chamber wall in which the axial flute(s) 420d is defined (cf.
Firstly, as also shown in
The rear lip seal 528b may also be provided with a rounded lip to form a symmetrical rear sealing element 528 which may be mounted on the piston member 114 either way round for simplifying assembly. Alternatively, just the forward lip seal 528a may have a rounded lip, with the rear lip seal 528a being, e.g., square cut.
Although the rear end 548d of the forward sealing element 548 is still spaced from the inner circumferential surface of the dosing chamber 520, as shown in
Notwithstanding these structural differences, the rear and forward sealing elements 528, 548 still function in the same way as their counterparts in the fluid dispenser 410 of
Secondly, the stopper portion 576 has a series of minor protrusions 576p which, unlike the minor roof protrusions of the fluid dispenser 410 (see
Thirdly, the carrier member 595 for the return spring 518 has a series of radially inwardly-directed protrusions 595h at the rear end of the annular body 595a which interfit with the stopper portion minor protrusions 576p to prevent rotation of the carrier member 512 relative to the stopper portion 576 and also to align the carrier member 595 in the correct angular orientation so that the clips thereof (not shown) will clip into the T-shaped tracks (not shown) in the nozzle 516, as previously described for the fluid dispenser 110 of
The carrier member 595 further has a pair of diametrically opposed arms 595j extending radially outwardly from the annular body 595a at its rear end.
Fourthly, the forward end wall 597c of the nozzle 597 has a subtly different geometry to reduce the dead volume in the dispenser 510, in particular in the fluid dispensement chamber 546.
Fifthly, the at least one axial flute 520d has a different geometry than that in
In this embodiment, the sides edges of the at least one flute 520d are angled to the longitudinal axis, rather than stepped as in the previous embodiments. The side edges of the at least one flute 520d may form an acute angle to the longitudinal axis, for instance in the range of 8° to 12°, such as 10°, and provide a lead-in surface to guide movement of the forward lip seal 548a into the forward dosing chamber section 520a on the forward stroke of the piston member 514. The floor of the at least one flute 520d may form a steeper acute angle to the longitudinal axis, for instance in the range of 15° to 25°, such as 20°.
It will be observed that the sealing tip 560 in this embodiment has a concave form through provision of a recess 560a′ therein. The sealing member 554 is formed (e.g. moulded) with a rear bulge 554s′ on its rear side to fit in the recess 560a′. Moreover, the sealing member 554 is formed (e.g. moulded) with a forward bulge 554t′ on its forward side to close the fluid outlet 552. When the fluid dispenser 510 is in its normal, rest state, the forward bulge 554t′ is forced to seal against the fluid outlet passageway 553c by the force applied by the sealing tip 560 to the rear bulge 554s′. However, when the sealing cap 560 is forced rearwardly by the increased fluid pressure created in the fluid dispensement chamber 546 as the piston member 514 pumps a metered volume of fluid through the one-way valve (see 589,
In yet another alternative tip seal arrangement, not shown, the rear bulge 554s′ may be omitted and the sealing tip 560 used to push the forward bulge 554t′ outwardly into sealing engagement with the fluid outlet passageway 553c. The sealing tip 560 in this case may also be modified to have a convex free end, such as in the fluid dispensers in
These arrangements using a forward bulge 554t′ in the sealing member 554 concentrate the tip forces in the centre of the sealing member 554, where the sealing of the fluid outlet passageway 553c is needed, and reduce the tip forces applied to the sealing member 554 over the swirl chamber feed channels, thereby reducing the likelihood of these channels being occluded (e.g. by creep of the sealing member 554).
In
It will be noted that the bottle 870 has a tapered bottom 870d, here of V-section, into which the inlet of the supply tube (not shown) extends. In this way, all or substantially all of the fluid will be drawn from the bottle 870, unlike the case where the bottle has a flat bottom.
In a modification to the above-described embodiments, not shown, the bottle seal may be omitted and a bore seal formed between the bottle neck and the inner annular skirt of the stopper portion.
In another modification to the above-described embodiments, not shown, the rear open end of the nozzle may be chamfered to provide a lead-in or guide surface for guiding insertion of the dispenser components thereinto.
In another modification to the above-described embodiments, not shown, the sealing cap (e.g. the sealing tip) may be connected to the sealing member so that when the sealing tip is moved rearwardly relative to the nozzle insert, at least the central portion of the sealing member sealing the fluid outlet is pulled rearwardly therewith to open the fluid outlet for dispensement of the metered volume of fluid.
One of the benefits of the tip seal arrangements disclosed herein, additional to those previously documented, is that they provide a commitment feature to the fluid dispenser, in that a higher operating force (the “commitment force”) is required at the start of the dispensing cycle to create the fluid pressure to overcome the sealing force applied to the sealing member by the sealing tip. Once the tip seal arrangement is opened, the commitment force is released to produce fast release of the fluid through the fluid outlet. This assists in providing accurate metering and reproducible fluid properties in each metered volume dispensed, such as droplet size distribution.
It will be understood that the afore-described fluid dispenser embodiments may be modified to include one or more of the components or features of the other embodiments. Moreover, it is to be understood that the materials described for making a component of one embodiment may also be used for the corresponding component of the other embodiments.
The fluid dispensers herein described with reference to
In this regard, possible such actuators are described and illustrated in UK patent application No. 0723418.0 filed 29 Nov. 2007, the content of which is incorporated herein by reference.
Another possible actuator is shown in
In
The fluid dispenser 910 is received in the housing 4409 such that its longitudinal axis L-L is aligned with (i.e. in-line or co-axial with) the longitudinal axis X-X of the housing 4409 (the “housing axis”). The fluid dispenser 910 is mounted in the housing 4409 for reciprocal translation along its longitudinal axis L-L and the housing axis X-X.
For simplicity, the following description will mainly refer to the housing axis X-X, but it is to be understood that each such reference applies equally to the longitudinal axis L-L.
The actuator 4405 comprises a finger-operable actuator mechanism 4415 to apply a lifting force to the fluid dispenser 910 directed along the axis X-X to result in the fluid dispenser 910 pumping a metered dose of the fluid from the nozzle 916. More particularly, the lifting force applied by the finger-operable actuator mechanism 4415 causes the bottle assembly (including the piston member, not shown) to translate forwardly along the axis X-X relative to the nozzle assembly (including the main housing, not shown) so that a metered dose of fluid is released (assuming priming has already occurred).
As shown, the finger-operable actuator mechanism 4415 is mounted to the housing 4409 so as to be movable (i) inwardly, in an actuating direction which is transverse to the axis X-X, from the rest position of
The finger-operable actuator mechanism 4415 has two members, namely (i) a finger-operable, rigid first member 4420 mounted to the housing 4409 to move inwardly-outwardly transversely to the axis X-X relative to the housing 4409, and (ii) a second rigid member 4425 carried on the first member 4420 so as to move therewith and to lift the bottle assembly of the fluid dispenser 910. The first and second members are made from a plastics material, and may be of ABS (e.g. Teluran® ABS (BASF)) and acetal, respectively.
As will be understood from
The first member 4420 is pivotally mounted to the housing 4409 so that the inward-outward movement of the first member 4420 transverse to the axis X-X is an arcuate movement. The first member 4420 has a rear end 4420a which fits into an axial channel 4409b formed in the housing 4409 and about which the first member 4420 pivots.
The second member 4425 is pivotally mounted on the first member 4420 such that upon application of an inward transversely-directed force (arrow F,
In more detail, and referring in part to
As shown in
The first (rear) arms 4425a of each pair extend in a direction generally transverse to the axis X-X, whereas the second (forward) arms 4425b are angled more forwardly towards the nozzle 916.
The bell crank 4425 has a generally inverted Y-shape with the first and second arms 4425a, 4425b forming the outer limbs and the mounting portion 4426 the inner limb. As can be seen, there is an angle of less than 90° between the first and second arms 4425a, 4425b.
As shown, the mounting portion 4426 comprises a spindle 4426a for pivotal connection to the lever 4420. Referring to
As will be appreciated from
The pusher surface 4429 for the second arms 4425b may be presented by a single wall feature of the housing 4409 or, as here, by separate housing wall features, one for each second arm 4425b.
The pivotal movement of the bell crank 4425 in the anti-clockwise sense A, on inward movement of the lever 4420, causes a lifting surface 4431 of each first arm 4425a to contact a respective bearing surface 976u provided by diametrically-opposed embossments 976r provided on the stopper portion 976 of the fluid dispenser 910.
To use the actuator 4405 to actuate the fluid dispenser 910, the user grasps the actuator 4405 in one hand and places a thumb and/or finger of that hand on the lever 4420. The user places the nozzle 916 in their nostril (or a nostril of another person) and applies a transverse force F to the lever 4420 so that the lever moves arcuately inwardly from the rest position to the operational (or actuated) position. In so doing, this causes the bell crank 4425 to pivot in the anti-clockwise sense A and the lifting surfaces 4431 of the first arms 4425a to act on the bearing surfaces 976u of the stopper portion embossments 976r to lift the bottle assembly of the fluid dispenser 910 upwardly relative to the stationary nozzle assembly and cause release of a metered dose of the fluid medicament into the nasal cavity (assuming the fluid dispenser 910 has been primed). The user then releases the force F applied to the lever 4420 to allow the return spring 918 to reset the actuator mechanism 4415 and the fluid dispenser 910 to their rest positions shown in
The user would then repeat the lever operation one or more times to release a corresponding number of further metered doses. The number of medicament doses to spray into the nasal cavity at any given time would be determined by the dosing regimen for the fluid medicament being administered. The dosing procedure can then be repeated until all, or nearly all, of the fluid in the bottle 910 has been administered.
To guide the reciprocal displacement of the fluid dispenser 910 in the housing 4409 along the axis X-X upon lever operation, the pair of diametrically-opposed embossments 976r of the stopper portion 976 each have a track 976v and a lead-in surface 976t. When the fluid dispenser 910 is mounted in the housing 4409, the rotary position of the stopper portion 976 is set such that the tracks 976v align with complementary, axially-oriented runners (not shown) formed on the inside surface of the housing 4409. In use, when the fluid dispenser 910 is axially displaced in the housing 4409, the tracks 976v ride over the runners. The co-operation of the tracks 976v with the runners not only guides the longitudinal displacement of the fluid dispenser 910 in the housing 4409, but also prevents the stopper portion 976, and in fact the bottle assembly as a whole, from rotating in the housing 4409. It will be appreciated that runners could be provided on the fluid dispenser 910 and complementary tracks provided on the inside of the housing 4409 to like effect.
The actuator 4405 further comprises a protective end cap (not shown) for mounting on the forward end of the housing 4409 to cover and protect the nozzle 916. The end cap is of the type used in VERAMYST® and disclosed in US-A-2007/0138207, having a pair of rearwardly extending lugs for receipt within suitably arranged channels 4451a, 4451b provided to the forward end of the housing 4409 to securely attach the end cap to the housing 4409 to cover the nozzle 916. The protective end cap also has, on its inner surface, a rearwardly-facing, resilient stopper of convex form arranged for sealing engagement with the fluid outlet 952 in the nozzle 916 when the end cap is in the nozzle covered position. The end cap is suitably made from the same material as the housing 4409, e.g. a plastics material, suitably ABS. The stopper may be made from a thermoplastic elastomer, for example SANTOPREN®).
When the cap is in the nozzle covered position, one of the lugs interferes with movement of the finger-operable actuator mechanism 4415, and in this particular instance the lever 4420 thereof, such as to prevent actuation (i.e. to lock movement) of the actuator mechanism 4415 when the end cap and lugs are in place (i.e. in the nozzle covered position) in much the same way as in VERAMYST® and disclosed in US-A-2007/0138207. In more detail, the forward end of the lever 4420 has a solid tab 4448. The tab 4448 bears against the inner edge of the slot 4409a to prevent the lever 4420 being moved outwardly through the slot 4409a. In addition, when the protective cap is received on the forward end of the actuator housing 4409 to cover the nozzle 916, one of the dependent lugs of the cap locates in front of the tab 4448 to prevent the lever 4420 moving inwardly. Thus, to use the actuator 4405, a user first has to remove the protective end cap.
The assembly of the actuator 4405 and the insertion of the fluid dispenser 910 therein will now be outlined.
The housing 4409 comprises forward and rear housing halves 4409e, 4409f, which snap fit together. Before the forward and rear housing halves 4409e, 4409f are snap-fitted together, the rear end 4420a of the lever 4420 is inserted into the retaining channel 4409b formed in the rear housing half 4409f so that the finger-operable actuator mechanism 4415 is retained by the rear housing half 4409f. To ensure that the bell crank 4425 is oriented correctly with reference to the pusher surfaces 4429 presented by the forward housing half 4409e after assembly of the housing 4409, the bell crank 4425 is pivoted anti-clockwise A while the housing halves 4409e, 4409f are snapped together. The bell crank 4425 then pivots back in the clockwise direction so that the second arms 4425b contact the housing pusher surfaces 4429.
After the housing halves 4409e, 4409f are assembled, the fluid dispenser 910 is inserted into the housing 4409 through a rear opening 4471a until the nozzle 916 is received in a forward opening 4471b. In this regard, the funnel-shaped lead-in surface 976t at the forward end of each track 976v of the stopper portion 976 helps guide the tracks 976v onto the runners in the housing 4409 when the fluid dispenser 910 is inserted or loaded into the housing 4409 through the rear opening 4471a of the housing 4409.
Moreover, the housing inner surface may be provided with a complementary profile to that of the outer plan profile of the stopper portion embossments 976r (see
The forward housing half 4409e has resilient clips 4409h adjacent the forward opening 4471b for a snap-fit connection to the nozzle 916. To limit the axial insertion of the nozzle 916 in the housing 4409, the nozzle 916 is provided with a series of protrusions or ribs 916p (cf. feature 116p in
As the fluid dispenser 910 moves forwards in the housing 4409 towards its forward end, the shoulder 916d and an outer skirt 916s of the nozzle 916 push on the underside of the first arms 4425a of the bell crank 4425 so that the bell crank 4425 pivots anti-clockwise A so as not to impede insertion of the fluid dispenser 910 to the position where it snap-fits in the housing 4409.
The bell crank 4425 is integrally formed with a spring leg 4480 projecting from the mounting portion 4426. When the bell crank 4425 is pivoted anti-clockwise A towards the forward end of the housing 4409 by the nozzle 916 on insertion of the fluid dispenser 910 into the housing 4409 during assembly, the spring leg 4480 is brought into engagement with the inner surface 4420d of the lever 4420 so as to be loaded. Once the embossments 976r on the stopper portion 976 pass the first (rear) arms 4425a of the bell crank 4425, the loading in the spring leg 4480 is released to pivot the bell crank 4425 back rearwardly so that the first bell crank arms 4425a are disposed underneath the embossment bearing surfaces 976u and the second bell crank arms 4425b bear on the housing pusher surfaces 4429.
The fluid dispenser 910 is moved to its fired position during insertion into the housing 4409 by an insertion force applied thereto. The insertion force is removed when the fluid dispenser 910 is snap-fitted into the housing 4409 whereby the return spring 918 moves the bottle assembly away from the captive nozzle assembly (i.e. towards the housing rear open end 4471a). As the spring leg 4480 of the bell crank 4425 has already pivoted the bell crank 4425 back to its rest position against the pusher surfaces 4429, the subsequent return movement of the stopper portion 976 brings the bearing surfaces 976u of the embossments 976r of the stopper portion 476 into engagement with, or into close proximity to, the associated lifting surfaces 4431 of the first arms 4425a of the bell crank 4425, as shown in
The rear opening 4471a is subsequently closed with an end cap (not shown), e.g. made of ABS, and the actuator 4405 is then “ready for use”.
The bell crank spring leg 4480 has particular utility in enabling the assembly of the fluid dispenser 910 to the actuator 4405 in an inverted state (i.e. upside down to the orientation shown in
If the actuator 4405 is dropped, or subject to other impacts, so as to cause the fluid dispenser 910 to move to its fully extended (open) position (i.e. where a separate carrier member 995 is used), when the stopper portion 976 moves farther away from the nozzle 916 the embossments 976r force the bell crank 4425 to distort, since the lever 4420 cannot move outwardly due to the lever tab 4448. In more detail, the first or lifting arms 4425a of the bell crank 4425 are forced to flex rearwardly due to the rearward force applied thereto by the embossments 976r. This keeps the bell crank lifting arms 4425a in engagement with the respective embossment bearing surfaces 976u, whereby simply pushing the lever 4420 inwardly will lift the bottle assembly forwardly to reset the fluid dispenser 910 in its rest position.
The actuator 4405 may be modified to have another corresponding actuating mechanism (not shown) on the other side of the housing 4409. The user would squeeze the levers 4420 together and in so doing cause the associated bell cranks 4425 to lift the bottle assembly forwardly from each side thereof.
As stated, the fully extended position, and its ability to prevent parts of the fluid dispenser 910 breaking in a drop event, is not available where the carrier member 995 is integrated with the stopper portion 976. However, where the bottle 970 is made from a lightweight material compared to glass, e.g. a plastics material, this drop resistance feature may not be strictly necessary, although perhaps still preferred for added protection. In other words, use of an integrated stopper portion 976 and carrier member 995 might need to be in combination with a lightweight, e.g. plastics, bottle 970, for instance such as that shown in
Those parts of the fluid dispenser or actuator herein described which are made from a plastics material are typically formed by a moulding process, and more typically by injection moulding.
In the exemplary embodiments the sealing arrangement at the fluid outlet 152; 352; 452; etc of the fluid dispenser 110; 310; 410; etc acts to prevent or inhibit the ingress of microbials and other contaminants into the dispenser 110; 310; 410; etc through the fluid outlet 152; 352; 452; etc and hence into the dosing chamber 120; 320; 420; etc and ultimately the bottle/reservoir of the fluid. Where the fluid is a liquid medicament formulation, e.g. for nasal administration, this enables the formulation to be free of preservatives or, perhaps more likely, to be a preservative-sparing formulation. In addition, the seal acts to prevent or inhibit the pending dose of the fluid in the dosing chamber from draining back into the supply or reservoir when the dispenser is in its rest configuration between actuations. This avoids or reduces the need for the dispenser to be primed for its next usage (priming then only effectively being required for the very first usage of the fluid dispenser so as to fill the dosing chamber, but not after the first usage).
In a modification of the fluid dispensers 110; 310; 410; etc herein, a sealing tubular sleeve, e.g. in the form of a gaiter, may be placed over the fluid dispenser so that it is sealed at one (rear) point (e.g. at or near a rear sleeve end) to the outer surface of the stopper portion 176; 376; 476; etc or fluid supply 170; 370; 470; etc and at another (forward) point (e.g. at or near a forward sleeve end) to the outer surface of the nozzle 116; 316; 416; etc. The material for the sealing sleeve is selected to be impervious to microbials and other contaminants, as are the seals formed between the sleeve and the dispenser parts. Suitable materials and seal techniques would be known to the skilled reader. Such a sealing sleeve would further protect the dispensers from microbial and other contaminant ingress thereinto. It would also allow the sealing tolerances inside the dispensers (i.e. other than the tip seal arrangement and the bottle seal 171; 371; 471; etc) to be reduced, since these seals (e.g. 128a,b/328a,b/428a,b; 165h; 365h/465h; 197p etc) would then be the second line of defence against ingress other than through the dispensing outlet 152; 352; 452; etc. The sleeve would need to accommodate the movement of the attached dispenser parts towards and away from one another, e.g. be expandable and/or contractible or have a length of sleeve material between the seal points at the maximum distance of separation thereof which is not stretching at that maximum distance, e.g. by having an excess length of sleeve material between the seal points. Slack in the sleeve material may therefore occur between the sleeve seal points when the dispenser parts are moved towards one another in the firing phase. The use of such a sealing sleeve would find use in other dispensers having one (e.g. rear) part which moves relative to another (e.g. forward) part to actuate the dispenser. The sealing sleeve would be sealed to each part.
The fluid dispenser of the invention may be used to dispense a liquid medicament formulation, e.g. for the treatment of mild, moderate or severe acute or chronic symptoms for prophylactic/palliative treatment. The precise dose administered will depend on the age and condition of the patient, the particular medicament used and the frequency of administration and will ultimately be at the discretion of the attendant physician. When combinations of medicaments are employed the dose of each component of the combination will in general be that employed for each component when used alone.
Appropriate medicaments for the formulation may be selected from, for example, analgesics, e.g., codeine, dihydromorphine, ergotamine, fentanyl or morphine; anginal preparations, e.g., diltiazem; antiallergics, e.g., cromoglycate (eg as the sodium salt), ketotifen or nedocromil (eg as the sodium salt); antiinfectives e.g., cephalosporins, penicillins, streptomycin, sulphonamides, tetracyclines and pentamidine; antihistamines, e.g., methapyrilene; anti-inflammatories, e.g., beclomethasone (eg as the dipropionate ester), fluticasone (eg as the propionate ester), flunisolide, budesonide, rofleponide, mometasone (eg as the furoate ester), ciclesonide, triamcinolone (eg as the acetonide), 6α, 9α-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-propionyloxy-androsta-1,4-diene-17β-carbothioic acid S-(2-oxo-tetrahydro-furan-3-yl) ester or 6α, 9α-Difluoro-17α-[(2-furanylcarbonyl)oxy]-11β-hydroxy-16α-methyl-3-oxo-androsta-1,4-diene-17β-carbothioic acid S-fluoromethyl ester; antitussives, e.g., noscapine; bronchodilators, e.g., albuterol (eg as free base or sulphate), salmeterol (eg as xinafoate), ephedrine, adrenaline, fenoterol (eg as hydrobromide), formoterol (eg as fumarate), isoprenaline, metaproterenol, phenylephrine, phenylpropanolamine, pirbuterol (eg as acetate), reproterol (eg as hydrochloride), rimiterol, terbutaline (eg as sulphate), isoetharine, tulobuterol or 4-hydroxy-7-[2-[[2-[[3-(2-phenylethoxy)propyl]sulfonyl]ethyl]amino]ethyl-2(3H)-benzothiazolone; PDE4 inhibitors eg cilomilast or roflumilast; leukotriene antagonists eg montelukast, pranlukast and zafirlukast; [adenosine 2a agonists, eg 2R,3R,4S,5R)-2-[6-Amino-2-(1S-hydroxymethyl-2-phenyl-ethylamino)-purin-9-yl]-5-(2-ethyl-2H-tetrazol-5-yl)-tetrahydro-furan-3,4-diol (e.g. as maleate); [α4 integrin inhibitors eg (2S)-3-[4-({[4-(aminocarbonyl)-1-piperidinyl]carbonyl}oxy)phenyl]-2-[((2S)-4-methyl-2-{[2-(2-methylphenoxy)acetyl]amino}pentanoyl)amino] propanoic acid (e.g as free acid or potassium salt), diuretics, e.g., amiloride; anticholinergics, e.g., ipratropium (eg as bromide), tiotropium, atropine or oxitropium; hormones, e.g., cortisone, hydrocortisone or prednisolone; xanthines, e.g., aminophylline, choline theophyllinate, lysine theophyllinate or theophylline; therapeutic proteins and peptides, e.g., insulin or glucagons. It will be clear to a person skilled in the art that, where appropriate, the medicaments may be used in the form of salts, (e.g., as alkali metal or amine salts or as acid addition salts) or as esters (e.g., lower alkyl esters) or as solvates (e.g., hydrates) to optimise the activity and/or stability of the medicament and/or to minimise the solubility of the medicament in the propellant.
Preferably, the medicament is an anti-inflammatory compound for the treatment of inflammatory disorders or diseases such as asthma and rhinitis.
In one aspect, the medicament is a glucocorticoid compound, which has anti-inflammatory properties. One suitable glucocorticoid compound has the chemical name: 6α, 9α-Difluoro-17α-(1-oxopropoxy)-11β-hydroxy-16α-methyl-3-oxo-androsta-1,4-diene-17β-carbothioic acid S-fluoromethyl ester (fluticasone propionate). Another suitable glucocorticoid compound has the chemical name: 6α,9α-difluoro-17α-[(2-furanylcarbonyl)oxy]-11β-hydroxy-16α-methyl-3-oxo-androsta-1,4-diene-17β-carbothioic acid S-fluoromethyl ester. A further suitable glucocorticoid compound has the chemical name: 6α,9α-Difluoro-11β-hydroxy-16α-methyl-17α-[(4-methyl-1,3-thiazole-5-carbonyl)oxy]-3-oxo-androsta-1,4-diene-17β-carbothioic acid S-fluoromethyl ester.
Other suitable anti-inflammatory compounds include NSAIDs e.g. PDE4 inhibitors, leukotriene antagonists, iNOS inhibitors, tryptase and elastase inhibitors, beta-2 integrin antagonists and adenosine 2a agonists.
Other medicaments which may be comprised in the formulation are 6-({3-[(Dimethylamino)carbonyl]phenyl}sulfonyl)-8-methyl-4-{[3-(methyloxy) phenyl]amino}-3-quinolinecarboxamide; 6a,9a-Difluoro-11b-hydroxy-16a-methyl-17a-(1-methycyclopropylcarbonyl)oxy-3-oxo-androsta-1,4-diene-17b-carbothioic acid S-fluoromethyl ester; 6a,9a-Difluoro-11i-hydroxy-16a-methyl-3-oxo-17a-(2,2,3,3-tetramethycyclopropylcarbonyl)oxy-androsta-1,4-diene-17i-carbothioic acid S-cyanomethyl ester; 1-{[3-(4-{[4-[5-fluoro-2-(methyloxy)phenyl]-2-hydroxy-4-methyl-2-(trifluoromethyl)pentyl] amino-6-methyl-1H-indazol-1-yl)phenyl]carbonyl}-D-prolinamide; and the compound disclosed in International patent application No. PCT/EP2007/053773, filed 18 Apr. 2007, in Example 24, and in particular the form which is 24C therein.
The fluid dispenser herein is suitable for dispensing fluid medicament formulations for the treatment of inflammatory and/or allergic conditions of the nasal passages such as rhinitis e.g. seasonal and perennial rhinitis as well as other local inflammatory conditions such as asthma, COPD and dermatitis.
A suitable dosing regime would be for the patient to inhale slowly through the nose subsequent to the nasal cavity being cleared. During inhalation the formulation would be applied to one nostril while the other is manually compressed. This procedure would then be repeated for the other nostril. Typically, one or two inhalations per nostril would be administered by the above procedure up to three times each day, ideally once daily. Each dose, for example, may deliver 5 μg, 50 μg, 100 μg, 200 μg or 250 μg of active medicament. The precise dosage is either known or readily ascertainable by those skilled in the art.
All usage herein of terms such as “about”, “approximately”, “substantially” and the like in relation to a parameter or property is meant to include the exact parameter or property as well as immaterial deviations therefrom.
The embodiments of the present invention described above are purely illustrative. The present invention relates to every novel aspect disclosed herein. Moreover, the present invention is not restricted to fluid dispensers used for administration of medicaments, but to fluid dispensers in general.
| Number | Date | Country | Kind |
|---|---|---|---|
| 0710315.3 | May 2007 | GB | national |
| 0723420.6 | Nov 2007 | GB | national |
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/EP2008/056655 | 5/30/2008 | WO | 00 | 3/10/2010 |
| Publishing Document | Publishing Date | Country | Kind |
|---|---|---|---|
| WO2008/145714 | 12/4/2008 | WO | A |
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| Number | Date | Country | |
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| 20100163582 A1 | Jul 2010 | US |
