Dispenser

A medicated inhalant dispenser has a plastics material body having a mouthpiece. A pressurized, inhalant source has a canister and a sprout which his moved towards the canister for release of a dose from the canister. The sprout is accommodated in a junction member, which is movable by a cam connected to a pivotal cover for the mouthpiece. Opening of the cover sets a breath actuable kink valve, having a nozzle through which the inhalant is released and a breath flap actuation. Opening also causes the junction member to be lifted for dose dispensing into the kink valve. Breathing in releases the dose for inhalation. A closed sleeve is provided for abutment of the end of the canister as the junction member is moved towards the canister. Between the canister end and an end of the closed sleeve, an adjustable abutment is provided.

CROSS REFERENCE TO RELATED APPLICATION

This application is for entry into the U.S. National Phase under §371 for International Application No. PCT/GB2006/003344 having an international filing date of Sep. 8, 2006, and from which priority is claimed under all applicable sections of Title 35 of the United States Code including, but not limited to, Sections 120, 363 and 365(c), and which in turn claims priority under 35 USC 119 to U.K. Patent Application No. 0518400.7 filed on Sep. 9, 2005.

BACKGROUND OF THE INVENTION

The present invention relates to a dispenser, particularly though not exclusively for dispensing aerosol or powder borne medicaments.

DESCRIPTION OF THE RELATED ART

In my prior International Patent Application, PCT/GB98/00770, at least as amended on entry in the European Regional Phase, there is described and claimed:

A dispenser for a gaseous, gas borne or droplet substance, the dispenser including:a body having a mouthpiece with an inhalation/insufflation orifice at its end;a junction in the body for a source of gas or evaporable liquid comprising or containing the said substance (the source being carried by the body); anda breath actuatable valve, for controlling the release of said gas or liquid, comprising:a valve inlet connected to the junction;a valve outlet;a flexible tube extending from the junction, between the inlet and the outlet, for receiving the said gas or liquid, the tube having a portion which is movable between a closed position in which the tube is kinked for closure of the valve and an open position in which the tube is un-kinked for opening of the valve; anda movable member, for moving the movable portion of the tube to control its kinking, and being movably mounted in the body for movement by the act of inhalation from a rest position towards the orifice—or at least in the direction of air flow through the dispenser;the tube being kinked to an obturating extent when the movable member is in a rest position and un-kinked when the movable member is moved on inhalation for release of the gas or liquid.

Such a dispenser can loosely be classed as a breath actuated, kink valve dispenser and is referred to herein as “My Earlier Breath Actuated, Kink Valve Dispenser”.

The main embodiments of My Earlier Breath Actuated, Kink Valve Dispenser included a piston acted on by a differential breath induced pressure. The resultant force generated is generally sufficient to operate the dispenser by drawing the piston towards the dispenser's mouthpiece and extending and opening the kink valve. Nevertheless, I felt that the dispenser is susceptible of improvement. In particular, in my British Patent Application published under No. 2,381,461 on 7 May 2003, I described and claimed: a dispenser for a gaseous, gas borne or droplet substance contained in a source thereof, the dispenser including:a body with a mouthpiece;a junction member in the body for the substance source; anda breath actuatable valve, for controlling the release of the gas or liquid containing or comprising the substance, the valve comprising:a flexible tube for receiving the said gas or liquid, the tube extending from a valve inlet connected to the junction member and having a portion which is kinkable for closure of the valve and movable to an open position in which the tube is un-kinked for opening of the valve; anda member arranged for movement in the body by inhalation to un-kink the valve;the tube being kinked to an obturating extent when the movable member is in a ready position and un-kinked when the movable member is moved on inhalation for release of the gas or liquid;
wherein:the movable member is or includes a flap arranged in the body for action of breath on it on inhalation;the junction member, the flexible tube and the movable flap are a single injection moulding of plastics material; andthe movable flap is pivotally connected to the junction member.

SUMMARY OF THE INVENTION

This dispenser is referred to herein as “My First Production Breath Actuated, Kink Valve Dispenser”. It is proving successful, particularly in combination with the “Unification Feature” of the dispenser described in and claimed in my British Patent Application published under No. 2,401,321 on 10 Nov. 2004, namely that of a dispenser for a gaseous, gas borne or droplet substance contained in a source thereof, the dispenser comprising:a substance source having:an external surface devoid of any feature intended for longitudinal location of the source anda spout displaceable inwards of the source to a dispense position for dispensing a substance dose from the source;a body having:a mouthpiece via which the substance dose can be inhaled anda socket sized for lateral location of the source via its external surface, but devoid of any body feature intended for longitudinal location thereof;a junction member for the spout, the junction member being arranged in the body to be slidable to a set position for displacing the spout to its dispense position;an action for slidably moving the junction member to the set position; anda unification of the source or a source locator to the body for locating the source longitudinally with the spout in its dispense position when the junction member is in its set position, the locator where provided extending from the body, outside the source and at least partially across the end of the source to provide a longitudinal location for the source, locating it when the movable junction member acts to depress the spout inwards of the source.

The unification enables tolerances in the source, particular its overall length from the end of the spout to the opposite end of its container, to be taken account of.

The object of the present invention is to provide an alternative means of taking account of the variation in the length of the container and relies on the inventive concept of measuring the position of the opposite end of the container and adjusting its abutment in the dispenser or the position of a member providing such abutment individually for each dispenser or indeed in a carrier for the container of the source.

According to a first aspect of the invention, there is provided an enclosed aerosol source comprising an assembled combination of the aerosol source combination as such and an enclosure:the aerosol source having:a canister,a spout at one end of the canister, the spout being movable inwards of the canister for substance release,a spring urging the spout outwards of the canister with a force required to be overcome for release movement inwards, anda valve for releasing a substance from the canister on longitudinal movement of the spout against the spring; andthe enclosure having:at least one dispense-mechanism, positioning feature at a determined position; andan adjustable location for the canister, the location being adjusted to provide a determined position of the spout with respect to the dispense-mechanism, positioning feature, when the aerosol canister has been assembled into the enclosure,
the arrangement being such that on movement of the spout through determined stroke with respect to the dispense-mechanism, positioning feature and against the spring substance release is predictable.

Normally the enclosed aerosol will be for use inhalation or insufflation of medicament.

Preferably, the dispense-mechanism, positioning feature is an abutment feature for a body including:a mouthpiece for inhalation/insufflation of the substance,a movable junction for receiving the spout anda dose release mechanism able to be cocked to move the junction and receive a substance dose and to be triggered by inhalation releasing a substance dose andan abutment feature for abutment of the enclosure abutment feature;the two abutment features being connected together.

Alternatively, the enclosure can include a mechanism for moving the canister towards the junction, the adjustable location being between the mechanism and the canister or between the mechanism and the enclosure and in which case:the dispense-mechanism, positioning feature is an abutment feature for a body including:a mouthpiece for inhalation/insufflation of the substance anda movable junction for receiving the spout andan abutment feature for abutment of the enclosure abutment feature;the two abutment features being connected together.

In either case, the two abutment features can be connected together either byinterengagement of complementary features or bya welded joint or byan adhesive joint.

In another alternative, the dispense-mechanism, positioning feature is a counter actuation feature, the enclosure including:an outer sleeve, having the counter actuation feature;an inner sleeve, within the outer sleeve and without the canister;an inner counter actuation feature on the inner sleeve complementary with outer sleeve feature, the features being adapted to index the sleeves with aerosol actuation;means for indicating indexation as a counter of aerosol actuation.

The adjustable location can take a variety of different forms, for instance:a compressible end location for the canister in the enclosure, ora part added to the enclosure, typically a washer of aluminium honeycomb material, ora deformable part of the enclosure, oran integrally moulded honey comb or set of radial ribs, ora rigid disc or washer pressed into the deformable part of the enclosure, ora sleeve surrounding the canister, in which case, the sleeve can be a portion of the enclosure in which the canister is an interference fit or the sleeve can be a series of ribs radiating inwards from the enclosure to the canister, oran adhesive between the canister and a sleeve of the enclosure surrounding the canister.

The enclosure will normally be imperforate at the end of the canister opposite from the spout and along the side thereof although the enclosure can be skeletal.

According to another aspect of the invention, there is provided an adjustment method, in the combining of an aerosol source and an enclosure of the first aspect of the invention, the method consisting in the steps of:measuring the overall length of the source from the distal end of its spout to its other end;adjusting the adjustable location.

Where the adjustable location is a compressible end location for the canister in the enclosure:the measurement step consists of measurement of the length of the source, andthe adjustment step consists of the adjusting the compressible end location to a standard dimension less the length of the source, the standard dimension being the distance from a support for the compressible location and the dispense-mechanism, positioning feature and a fixed use dimension from the dispense-mechanism, positioning feature to the end of the spout.

Whilst the overall length of the source can be measured, the measurement step can consist of indirectly measuring the length of the source by measuring the position of the end of the source with respect to a datum in the body, with the source and the spout held towards the junction with no end float, the location then being adjusted to provide a determined position of the end of the source in comparison with the dispense-mechanism, positioning feature.

The adjustable location can be adjusted by a variety of means, for instance, by:machining, or bycrushing with a force controlled to be a determined amount higher than the dose release force of the source, in which case the crush force is preferably substantially double the release force, or byurging one portion of the adjustable location which is a tight fit on another portion to an adjusted position, or byplastic deformation of the adjustable location.

The adjustable location can be an interference fit of a sleeve in the enclosure with the side of the canister, and in which case:the measurement step consists of measurement of the length of the source, andthe adjustment step consists of the adjusting the longitudinal position of the canister in the enclosure to a fixed used dimension from the dispense-mechanism, positioning feature to the end of the spout, the canister remaining in position due to interference between the sleeve and the canister.

Alternatively, the adjustable location can include an adhesive between the canister and a sleeve of the enclosure surrounding the canister, and in which case:the measurement step consists of measurement of the length of the source, andthe adjustment step consists of the adjusting the longitudinal position of the canister in the enclosure to a fixed used dimension from the dispense-mechanism, positioning feature to the end of the spout and setting/allowing to set the adhesive, the canister remaining in position due to the adhesive between the sleeve and the canister.

Again the measurement step can be made with the dose release mechanism in its state for moving the spout for release of a dose from the source and the source urged towards the junction for such release and the adjustment being compensated for stroke of the junction and the spout.

Alternatively the measurement step can be made with the spout in its quiescent position with respect to the source and the junction and the release mechanism being in their normal rest position state from which they are moved for dose release.

Preferably, the adjustment of the adjustable location is such that the canister is supported with negligible end float.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring first toFIGS. 1 to 8, a medicated inhalant dispenser1has a plastics material body2having a mouthpiece3. A pressurised, metered dose, inhalant source4has an aluminium canister5and a spout6, which is moved towards the canister for release of a dispensing or a dose from the canister. The spout is accommodated in a junction member7, which is movable by a cam8connected to a pivotal cover9for the mouthpiece. Opening of the cover sets a breath actuable kink valve10, having a nozzle11through which the inhalant is released and a breath flap12actuation. Opening also causes the junction member to be lifted for dose dispensing into the kink valve. Breathing in releases the dose for inhalation.

This operation is described in more detail in my British Patent Application published under No. 2,381,461 on My First Production Breath Actuated, Kink Valve Dispenser.

In that dispenser, the source was pinned in the body at a crimp13. However, this can cause reliability issues in the stack up of tolerances. The Unification feature addressed these issues.

In the dispenser of the present invention, a closed sleeve20is provided for abutment of the end21of the canister as the junction member is moved towards the canister. Between the canister end21and an end22of the closed sleeve, an adjustable abutment23is provided. The closed sleeve is located on the body by contact of a dispense-mechanism, positioning step24in its orifice with an end surface25of a source receptacle26of the body2of the dispensing mechanism. At a skirt27of the closed sleeve, the latter is laser welded L to the receptacle26, i.e. to the body2, at an end portion28of the receptacle26. This arrangement provides that the closed sleeve is positioned on the body with well toleranced dimensions. Thus the dimension D between the bottom of a bore29in the junction member7and abutment face30of the closed end22, whether the junction member is in its quiescent position shown inFIG. 1or its advanced dose dispensing position shown inFIG. 2is closely predictable.

However, due to its structure involving compressed, elastomeric members (not shown) and the crimp closure12of the source, the overall length of the source from distal end31of the spout to the opposite canister end21is not predictable with the same degree of certainty. Accordingly reliable operation cannot be predicted with sufficient certainty.

In accordance with the invention, the abutment or end location23is sized to provide that the source is supported in its correct position for opening of its valve on operation of the cam mechanism8.

This sizing is a two stage operation:1. The dimension from the end21of the source to the end surface25of the source receptacle26is measured. This measurement is shown inFIG. 3by the arrows I and II, indicating two actual measurements from a datum with the desired measurement being the difference of the actual measurements. This measurement operation can be performed in any conventional manner known to the man skilled in the art and is likely to be performed optically on a production line.2. With knowledge of the effective length of the source, the actual length being predictable as the effective length plus the distance below the surface25at which the end of the spout is located, the required length of the end location23can be calculated, taking account of length of the closed sleeve. As shown inFIG. 5the abutment is compressed to the required length. The end location itself is a disc32of aluminium honeycomb of a wall thickness that can be readily compressed to the required dimension, yet can resist the force exerted on it in operation, when the canister is urged against it. It should be noted that the compression is plastic and permanent. The compression is carried out with the disc in situ in the closed sleeve against the end surface25and by means of a plunger33. Conveniently the plunger is the same thickness as the depth of the skirt step27, whereby the effective depth of the closed sleeve from the compressed surface abutment face34of the disc to the step24is the same as the dimension top of the plunger to the end35of the skirt.

After sizing of the abutment, the closed sleeve is assembled to the body over the source, with the step abutting the end surface of the body. The skirt is then laser welded to the body. The result is that the source is supported firmly for displacement of the spout inwards on operation of the cam mechanism by opening of the cover.

To avoid any possibility of the source being permanently under slight compression, the abutment may be compressed by a small amount extra to allow a small, but defined lost motion on initial movement of the cam.

Referring now toFIG. 9, an alternative abutment is shown in a sleeve120analogous to the sleeve20. It is of injection moulded plastics material. At the inside of its end122, it is provided with many thin, radial ribs151, arranged around the radially outer part of the inside of the end122. The ribs are plastically deformable. They can be compressed and form an abutment or adjusted location directly themselves for the source. Alternatively, a solid disc152, of metal or plastics material can be used to provide an actual abutment or location surface for the end of the source.

Each ofFIGS. 10 and 11show diagrammatically a cam-driven source-movement mechanism251,351, respectively above and below a honeycomb compressible abutment223,323having a reinforcement disc252,352. InFIG. 10, the mechanism is coupled to the sleeve220and acts on the disc252to drive the source towards the junction member (not shown) in the dispenser, the junction member being fixed with respect to the sleeve and the body of the dispenser in this instance. The abutment is sized in like manner to the abutment23, as described above. InFIG. 11, the abutment323acts directly against the inside of the end322of the container, with a fixed part360of the mechanism acting on the reinforcement disc352. A movable part361, a cam as drawn, acts directly on the source.

Turning on toFIG. 12, a dispenser401, which is not breath actuated, is shown. It has a junction member407fixed in its body402. Its source404includes a canister405and a pair of concentric sleeves475,476, which are arranged with a ratchet mechanism477to drive an indicator478along a slot479in the outer sleeve to indicate the number of doses dispensed and remaining to be dispensed. The ratchet mechanism is an intricate device and its reliable operation can be adversely affected by the loose tolerances to which the source is assembled. A location member423, sized in a manner analogous to that in the above embodiments, is provided between the canister405and the end422of the outer sleeve475. Sizing of the location provides that the complementary parts of the mechanism inter-engage correctly for their reliable operation.

It should be noted that for the purposes of the present invention, this counter for counting the number of doses is included in the term “dispense-mechanism”, namely a mechanism in a dispenser which is operated on dispensing of a dose.

Turning now to the dispenser shown inFIG. 13, it has substantial similarity with that ofFIG. 1, and its source end only is shown in cross-section. Its adjustable location523is reinforced in its positioning of its source504, by adhesive551provided between sleeve520and the canister. Use of the adhesive provides that should the spring of the valve within the source be outside tolerance, there is a reserve of location strength and the crushable location is not unintentionally crushed further. The adhesive551can be applied in such a way as to fasten the sleeve520to the body502in addition to fastening the source in the sleeve at the positioning features524,525.

Turning on again toFIGS. 14 and 15, the sleeve620has internal ribs6201along its length, which are an interference fit with the source604. The skirt627and the end portion628of the body602have respective complementary formations6271,6281, which inter-engage when the sleeve is fitted to the body. The source is pushed into the sleeve to provide the desired dimension between the end of the sleeve and end of the spout. The fit is such is as to hold the source in its use position. This embodiment has the advantage of using entirely mechanical location of the source and connection of the sleeve to the body.

More generally, it should be noted that, the tolerance in the size of the body, the enclosure sleeve, the junction and the other parts of the dose dispense-mechanism, being injection moulded members, are considerably tighter than those of the source, whose valve includes elastomeric members held together with a metallic crimp. Accordingly, measurement of the length of the source and adjusting the abutment to this length and the nominal size of the moulded members can provide support of the source for reliable operation. The length of the source can be measured indirectly by measuring the position of the end of the source with respect to a datum in the body, with the source and the spout held towards the junction member with no slack. The location can then be adjusted to provide a determined position of the source when supported in comparison with another datum on the sleeve.

Whilst it is possible for the measurement to be made with the dose dispense-mechanism in its state for moving the spout for release of a dose from the source and the source urged towards the junction for such release and the adjustment being compensated for stroke of the junction member and the spout; in the above embodiments, the measurement is made with the spout in its quiescent position with respect to the source and the junction member and the release mechanism being in their normal rest position state from which they are moved for dose release.

It is envisaged that the abutment may be adjusted by machining, however in the preferred embodiments using a crushed location, crushing is with a force controlled to be a determined amount higher than the dose release force of the source, i.e the force required to overcome the aerosol valve spring. Typically, where the release force is 40N, the crush force is approximately 80N or more.