WO2018051371A2

WO2018051371A2 - Powder dispenser

Info

Publication number: WO2018051371A2
Application number: PCT/IN2017/050404
Authority: WO
Inventors: Geena Malhotra; Srinivasan JANARDHANAN
Original assignee: Cipla Limited
Priority date: 2016-09-16
Filing date: 2017-09-16
Publication date: 2018-03-22
Also published as: WO2018051371A3

Abstract

The invention relates to a dispenser for delivering powder to the nose, the dispenser comprising, a body, a powder container, an outlet and an actuator. The body defines a piston chamber including a conduit providing a fluid pathway to a container chamber and the container chamber comprises the powder container. The powder container defines an internal volume within which a predetermined dose of powder is located and the powder container includes an inlet aperture sealed by an inlet seal at a conduit end and an outlet aperture sealed by an outlet seal at an outlet end. The powder container is arranged in a fluid flow path between the conduit and the outlet such that fluid flow from the conduit to the outlet is substantially prevented by the inlet and outlet seals of the powder container. The actuator includes a piston and a piercer and is coupled to the body such that it is movable relative to the body from a first position to a second position.

Description

Powder Dispenser

Field of the Invention:

The invention relates to a dispenser for delivering a powder to a location, in particular delivering a medicament powder to the nose of a user and to a method of assembling and using such a device.

Background of the Invention and Prior Art:

The use of dispensers, particularly nasal delivery devices, to deliver a medicament to the nose and/or nasal cavity of a user is well known and there have been many devices adapted for such use. Spray bottle devices, for example squeezable bottles with a spray nozzle, can be used to deliver a fine spray of liquid up the nose, but accurate dosing using such devices can be difficult due to the differences in the ability of different users to squeeze the bottle. The active delivery of powders to the nose and/or nasal cavity has also been previously considered. Active delivery, in which the powder is ejected from the device, rather than inhaled from the device, can assist with such delivery.

A single powder dose nasal delivery device is disclosed in US2016/0167071 in which a piston is used to drive air to in turn eject powder from a container.

Such dispensers may be complex to manufacture or assemble and the handling of medicament doses to be dispensed can present difficulties during manufacture. The present invention seeks to provide a dispenser that addresses at least some of the disadvantages with the prior art.

Summary of the Invention:

This summary is provided to introduce a selection of concepts in a simplified format that are further described in the detailed description of the invention. This summary is neither intended to identify key or essential inventive concepts of the invention, nor is it intended for determining the scope of the invention.

In an embodiment, the present subject matter refers a dispenser for delivering powder, the dispenser comprising a body, a powder container, an outlet and an actuator, in which:

the body defines a piston chamber including a conduit providing a fluid pathway to a container chamber, the container chamber comprising the powder container;

the powder container defines an internal volume within which a predetermined dose of powder is located and the powder container includes an inlet aperture sealed by an inlet seal at a conduit end and an outlet aperture sealed by an outlet seal at an outlet end; the powder container is arranged in a fluid flow path between the conduit and the outlet such that fluid flow from the conduit to the outlet is substantially prevented by the inlet and outlet seals of the powder container;

the outlet comprises an outlet opening; and

the actuator includes a piston and a piercer and is coupled to the body such that it is movable relative to the body from a first position to a second position such that:

in the first position the piston is arranged at a first end of the piston chamber to define an air chamber between the piston and the conduit and the piercer extends into the air chamber; and

during movement of the actuator from the first position to the second position the piston moves within the piston chamber away from the first end and towards the conduit, thereby reducing the volume of the air chamber, and the piercer pierces the inlet seal and the outlet seal of the container such that the air chamber becomes fluidly connected to the outlet by a flow path that extends through the conduit and through the powder container allowing fluid to pass from the air chamber and through the outlet opening.

In an implementation, the piercer includes a piercing end and a release portion with a seal surface arranged therebetween, the piercer being arranged such that during movement of the actuator from the first position to the second position the piercer moves through the conduit, and a seal portion of the conduit forms a substantially fluid tight seal when aligned with the sealing surface, but not when aligned with the release portion, such that the piercer substantially prevents fluid flow through the conduit when the seal surface is aligned with the seal portion and permits fluid flow through the conduit when the release portion is aligned with the seal portion, the arrangement being such that during movement of the actuator from the first position to the second position the seal portion is first aligned with the seal surface and then with the release portion.

In another implementation, when the actuator is in the second position, the release portion is aligned with the seal portion.

In yet another implementation, the piercer extends along a piercer axis, the seal surface is substantially cylindrical and has a first radius from the piercer axis and the release portion includes regions which have a radial extent from the piercer axis of less than the first radius.

In yet another implementation, the piercing end is tapered towards a point. In yet another implementation, during movement of actuator from the first position to the second position, the piercing end pierces both the inlet and outlet seals of the powder container prior to the release portion becoming aligned with the seal portion of the conduit.

In yet another implementation, the piercer extends from the piston into the air chamber in the first position.

In yet another implementation, the powder container is a separate component arranged within the container chamber.

In yet another implementation, the predetermined dose of powder comprises a predetermined dose of medicament for delivery to the nose or nasal cavity or mouth or oral cavity of a patient.

In yet another implementation, the outlet comprises an outlet part which extends over the container chamber and includes the outlet opening.

In yet another implementation, the outlet part is shaped for insertion into the nostril of a user.

In yet another implementation, the outlet part is a snap fit to the body and secures the powder container within the container chamber.

In yet another implementation, a locking sleeve is provided to which the body and actuator are snap fitted during assembly of the dispenser to thereby couple the body to the actuator.

In yet another implementation, the body and actuator are retained in the first position by a delivery lock, provided by the locking sleeve, which prevents separation of the body and actuator and which allows movement of the actuator towards the second position only once an actuation threshold resistance has been overcome.

In yet another implementation, the locking sleeve provides a post-use lock which is activated when the actuator reaches the second position and substantially prevents the actuator from moving from the second position to the first position.

In yet another implementation, the piercer is coupled to the actuator using a snap fit connector.

In yet another implementation, the piston is arranged between the piercer and actuator such that coupling of the piercer to the actuator secures the piston to the actuator.

In yet another implementation, the dispenser includes a dust cover which substantially covers the outlet.

In another embodiment, the present subject matter refers a method of assembling a dispenser for delivering powder to the nose, the dispenser comprising, a body, a powder container, an outlet and an actuator, the dispenser being substantially as described in any preceding embodiment and corresponding implementations, and the method of assembly including the steps of:

coupling the body to the actuator;

arranging a powder container in the container chamber;

securing the powder container in the container chamber by securing an outlet to the body.

In an implementation, the method step of coupling the body to the actuator comprises using a snap fit coupling to couple the body to the actuator.

In an implementation, the method comprises the steps of:

moving the actuator towards the second position;

causing the piercer to pierce the inlet and outlet seals of the powder container; and causing air to flow from the air chamber, through the powder container and out of the outlet opening, the airflow entraining powder from the powder container and carrying it through the outlet opening.

To clarify advantages and features of the present invention, a more particular description of the invention will be rendered by reference to specific embodiments thereof, which is illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. The invention will be described and explained with additional specificity and detail with the accompanying drawings.

Detailed Description of the Invention:

The invention provides a dispenser, the dispenser comprising a body, a powder container, an outlet and an actuator, in which:

the powder container defines an internal volume within which a predetermined dose of powder is located and the powder container includes an inlet aperture sealed by an inlet seal at a conduit end and an outlet aperture sealed by an outlet seal at an outlet end;

the powder container is arranged in a fluid flow path between the conduit and the outlet such that fluid flow from the conduit to the outlet is substantially prevented by the inlet and outlet seals of the powder container;

the outlet comprises an outlet opening; and the actuator includes a piston and a piercer and is coupled to the body such that it is movable relative to the body from a first position to a second position such that:

in the first position the piston is arranged at a first end of the piston chamber to define an air chamber between the piston and the conduit, and the piercer extends into the air chamber; and

The inclusion of a piston and piercer that are moved by the actuator from a first position to a second position as described creates a dispenser in which a simply sealed powder container can be used and which is only opened, or unsealed, during actuation. The piston causes the volume of the air chamber to be reduced and this causes air to pass from the air chamber through the conduit. When the inlet and outlet seals have been pierced, or otherwise broken by the piercer, an air path is created between the air chamber and the outlet so that air can flow from the air chamber, through the conduit, through the powder container in the container chamber and to the outlet. The air flow through the powder container may be sufficient to deagglomerate the powder therein, to aerosolise the powder therein, or to entrain some, or all, of the powder therein to carry it to the outlet and out of the outlet opening.

The powder container includes a predetermined dose of powder. The powder may be a medicament powder and the predetermined dose of powder may include all, or a predetermined part, of a therapeutically effective dose of the medicament. The powder may comprise one or more therapeutically active components, together with one or more excipients, such as carriers, bulking agents or stabilising agents. The excipients may be essentially inert and be present to alter the physical properties of the powder, or may enhance one or more aspects of a therapeutic compound, for example by stabilising the compound to enhance shelf life.

The dispenser of the present invention is intended for delivering powder to a location, in particular it is intended that the dispenser will be suitable for dispensing a powder to the nose of a user. Delivering powder to the nose of a user includes delivery to the nostril and / or nasal cavity of a user for prophylaxis and/ or treatment of any associated disorder/ disease. The user may further inhale the powder such that at least some of the powder passes into the lungs of a user.

Alternatively, the dispenser of the present invention is intended for delivering powder to a location, in particular it is intended that the dispenser will be suitable for dispensing a powder through the mouth of a user. Delivering powder to the mouth of a user includes delivery to the oral cavity of a user through inhalation for the purposes of reaching the lungs of the user for prophylaxis and/ or treatment of any associated disorder/ disease.

The body of the dispenser may be any suitable shape. The body may be generally cylindrical about a first axis as this is a convenient shape for manufacturing and, due to the rotational symmetry of the shape, can facilitate assembly.

The body defines a piston chamber which may be substantially circular in cross section in a direction perpendicular to the first axis along which the dispenser extends. The piston chamber may be substantially cylindrical in shape. The piston chamber may include a roof at a second end, opposite the first end, which includes the conduit that provides a fluid pathway to a container chamber. The conduit may be provided in the form of a tube which extends from the roof into the piston chamber. The conduit may extend substantially along the first axis along which the dispenser extends.

The container chamber comprises the powder container. The powder container may be integrally fabricated with the container chamber, but may be a separate component as this allows a separation of the powder handling manufacturing, which may require precautions against hazardous material if the powder is therapeutically active. Thus a manufacturer of components for the dispenser need not handle pharmaceutically active compounds. Components manufactured can be transported and assembled on another site where the powder container can be added, or components can be partly assembled and then shipped to another site for the addition of the powder container.

The powder container may be any suitable shape. The powder container may include a container wall which defines a substantially cylindrical cavity. The cavity includes an inlet and an outlet aperture which may be any suitable shape. The inlet and outlet apertures may be sized to allow the piercer to pass through substantially without deforming the powder container or piercer and may be substantially circular. When the piercer extends through the inlet and outlet apertures of the container, a substantial annular gap between the inner edges of the inlet and outlet apertures and the piercer may be created to define an air flow path into, or out of, the powder container. The air path between the piercer and the container apertures may be substantially annular. The piercing of the inlet and outlet seals of the powder container may move the seal material away from the piercer so that the seal material does not prevent air flow through the air flow path. The seal material may be forced out of the way by air pressure as air is forced from the air chamber.

The inlet and outlet seals may be made of any suitable material, for example a laminate, or sheet, material comprising one or more layers including for example, one or more of a plastic layer and a metallic layer. The seal material is pierceable, or breakable, by the piercer in use.

The outlet may be any shape suitable for the use to which it is intended to put the dispenser. For a nasal dispenser the outlet may be shaped and sized for insertion into the nostril of a user and the outlet opening may be located at an end of outlet furthest from the body of the dispenser so that powder dispensed from the dispenser can dispense into the nostril or nasal cavity of a user into whose nostril the outlet is inserted.

Alternatively, for an oral dispenser, the outlet may be shaped and sized for insertion to the mouth of the user and the outlet opening may be located such that the powder dispensed from the dispenser gets dispensed at the back of the throat without any substantial deposition of the powder in the throat section of the user so as to reach the target site.

The piercer may be elongated and may be any suitable shape. The piercer may include a piercing end and a release portion with a seal surface arranged therebetween. The piercing end may be tapered towards a point as this can reduce the force required for the piercer to pierce the seal. It should be understood that the tapering need not reach a sharp point, such as that of a needle or hypodermic, but could be a rounded point, or a substantially blunt end. However, it should be understood that the term pierce is used herein to mean breaching the seal in any way. The breaching of the seal could be by piercing with a substantially pointed piercing end, could be by cutting with a blade like piercing end, or could be through force causing distortion and failure of the seal with a substantially blunt piercing end. Piercing with a pointed piercing end, or cutting with a sharpened piercing end, may be preferred as these methods can result in a more reliable and / or reproducible breaching of the seal.

The piercer may be arranged such that during movement of the actuator from the first position to the second position, the piercer moves through the conduit. In the first position the piercer may extend into and through the air chamber such that the piercing end and or a part of the seal surface is arranged in the conduit.

The conduit may include a seal portion which forms a substantially fluid tight seal when aligned with the sealing surface of the piercer. It should be understood that the seal surface is considered aligned with the seal portion of the conduit when the piercer extends within, or through the conduit and, the seal surface is in contact with the seal portion of the conduit. The seal portion and the sealing surface may have similar cross sectional shapes, for example the seal surface may be substantially cylindrical and the seal portion may be substantially circular having a diameter similar, or slightly smaller than the diameter of the seal surface.

No such fluid tight seal is created when the seal portion is aligned with the release portion of the piercer. The release portion may have a radial dimension smaller than that of the seal surface and / or may not have the same cross sectional shape. The release portion may have a substantially circular cross section, but with a diameter smaller than that of the seal surface, or may have a non-circular cross section, with grooves, or valleys, extending along the piercer to provide air channels between the release portion of the piercer and the seal portion. The seal portion may be substantially circular and the seal surface and release portion may be substantially circular in cross section, with the release portion having a smaller diameter than the seal surface and the seal portion.

The inclusion of the seal surface, seal portion and release portion in the dispenser may mean that the piercer substantially prevents fluid flow through the conduit when the seal surface is aligned with the seal portion and permits fluid flow through the conduit when the release portion is aligned with the seal portion, the arrangement being such that during movement of the actuator from the first position to the second position the seal portion is first aligned with the seal surface and then with the release portion. This sequential alignment of the seal surface and subsequently the release portion, as the actuator is moved towards the second position, allows the air in the air chamber to be compressed as the piston moves towards the conduit end of the air chamber and for the compressed air to be released only when the release portion is aligned with the seal portion. By controlling the length of the seal surface of the piercer and the position of the release portion, the compression and subsequent release of the compressed air can be coordinated with the piercing of the inlet and outlet seals. For example, the interaction between the piercer and the seal portion may be arranged such that both the inlet and outlet seals are pierced before the release portion becomes aligned with the seal portion. In this way, when released, the compressed air from the air chamber can immediately flow through the conduit, powder container and out of the outlet opening. The compression of the air prior to its release can result in an energetic discharge of air from the air chamber and the resulting air flow may deagglomerate, aerosolise and entrain some, or all, of the powder. The seal between the seal portion and the seal surface can also prevent powder from the powder container falling into the air chamber when the inlet seal of the powder container is pierced.

When the actuator is in the second position the release portion may be aligned with the seal portion.

The piercer may extend along a piercer axis, which may be substantially the same as the first axis along which the dispenser extends. The seal surface may be substantially cylindrical having a first radius from the piercer axis and the release portion may include regions which have a radial extent from the piercer axis of less than the first radius.

The outlet may comprise an outlet part which extends over the container chamber. The outlet part may include an inner shoulder that, in use, retains a powder container within the container chamber. The powder container may include a container-flange which is trapped between an upper rim of the container chamber and the inner shoulder of the outlet. The outlet may be coupled to the body by a push fit, or a snap fit coupling, but could be coupled using a separate fixing, a screw coupling, bayonet coupling or adhesive.

A locking sleeve may be provided to which the body and actuator are snap fitted during assembly of the dispenser to thereby couple the body to the actuator. Although a sliding coupling could be provided directly between the body and the actuator, it has been found that manufacturing and assembly may be facilitated if the dispenser includes a locking sleeve. The actuator and body may be coupled to the locking sleeve using one or more snap fit couplings.

The body and actuator may be retained in the first position by a delivery lock. The delivery lock may be provided by the locking sleeve. The delivery lock may prevent separation of the body and actuator, which prevents dismantling of the dispenser. The delivery lock may allow movement of the actuator towards the second position only once an actuation threshold resistance has been overcome. This helps to prevent unintentional actuation of the device. The actuation threshold force can also be set at a level sufficiently higher than the force required to complete actuation, including compression of the air in the air chamber, of the dispenser meaning that a user overcoming the actuation threshold is likely to complete the actuation.

The locking sleeve may provide a post-use lock which may be activated when the actuator reaches the second position. The post-use lock may substantially prevent the actuator from moving from the second position to the first position. This ensures that the device, once actuated, is secured in a post-use state so that a user cannot re-use the dispenser and is unlikely to be confused into thinking that a further dose is available. The piercer may be coupled to the actuator using a snap fit connector. The piston may be arranged between the piercer and actuator such that coupling of the piercer to the actuator secures the piston to the actuator.

The dispenser may include a dust cover which substantially covers the outlet.

There is also provided a method of assembling a dispenser for delivering powder to the nose, the dispenser comprising, a body, a powder container, an outlet and an actuator, the dispenser being substantially as described above, and the method of assembly including the steps of:

coupling the body to the actuator;

arranging a powder container in the container chamber;

The method step of coupling the body to the actuator may comprise using a snap fit coupling to couple the body to the actuator. The assembling of the dispenser may require moving components towards one another only substantially along the first axis of the device. Snap fit or push fit coupling are particularly suitable for such assembly and having a single direction of movement to bring the components together during assembly can significantly simplify manufacturing as complex manipulations of components can be avoided. It will be understood that components may be translated and or rotated relative to the first axis to appropriately align them with the axis, but the assembling step during which they are placed, or coupled, together may involve movement only substantially along the first axis.

The invention also provides a method of dispensing a powder dose from a dispenser, the dispenser being substantially as described above and the method comprising the steps of: moving the actuator towards the second position;

By creating an airflow that carries the powder out of the outlet, an opening inspiratory effort on the part of the user is not required to extract the powder from the powder container. Such inspiratory effort may be detrimental for delivery of powder to the nostril or nasal cavity. Each part of the dispenser may be fabricated from a suitable material and this material need not be the same for each part. Each part may be a moulded plastic part, with the exception of the seals covering the inlet and outlet apertures of the powder container. Brief Description of the Drawings:

The invention will now be described by way of example only with reference to the following figures in which:

Figure 1 shows a dispenser including a dust cap;

Figure 2 shows an exploded cross section of the dispenser of Figure 1 without the dust cap;

Figure 3 shows a detailed view of the actuator of Figure 2;

Figure 4 shows a detailed view of the powder container of Figure 2;

Figure 5 shows the dispenser of Figure 2 with the actuator in the first position; and

Figure 6 shows the dispenser of Figure 2 with the actuator in the second position.

Figure 1 shows a dispenser 1 for delivering powder to the nose of a user, for example to a nostril or nasal cavity of the user. The dispenser 1 comprises a body 2, an actuator 4 and an outlet, in this case an outlet part 6, the body 2 being arranged between the actuator 4 and the outlet part 6. The outlet part 6 is substantially covered by a dust cap 8, in this case a transparent cap, and includes an outlet opening 10. Between the actuator 4 and the body 2 is a locking sleeve 18.

The dispenser 1 extends substantially along a first axis 14 (shown in Figure 2). The body 2 comprises finger projections 12 extending from opposing sides of the body 2. The finger projections 12 provide support surfaces 16 which extend substantially perpendicular to the axis 14 and face towards the outlet part 6.

The actuator 4 extends away from the body 2 and terminates in a finger engaging surface 20 at an end 22 thereof. The finger engaging surface 20 extends substantially perpendicular to the first axis 14 and is directed away from the outlet part 6 such that a compression force can be applied by pressing on the support surface 16 of the finger projections 12 and the finger engaging surface 20 of the actuator 4.

Figure 2 shows an exploded cross section view of the dispenser 1 of Figure 1 without the dust cap 8. In this figure it can be seen that the body 2 defines a piston chamber 24 and a container chamber 26 which are linked by a conduit 28 which creates a fluid pathway 31 from the piston chamber 24 to the container chamber 26. A powder container 30 (shown in more detail in Figure 4) is dimensioned so as to fit within the container chamber 26. The powder container 30 comprises a circumferential wall 32, in this case substantially cylindrical, and has an inlet end 34 and an outlet end 36. The powder container 30 defines a cavity 46, the inlet end 34 includes an inlet aperture 38 into the cavity 46 which is sealed by an inlet seal 40 and the outlet end 36 includes an outlet aperture 42 into the cavity 46 which is sealed by an outlet seal 44. The cavity 46 contains a predetermined dose of powder 48, in this case a medicament powder comprising a predetermined dose, which in this case is a complete therapeutic dose, of therapeutically active medicament.

The actuator 4 comprises a piston 50 and piercer 52. The actuator 4 is coupled to the body 2 by the locking sleeve 18 such that the actuator 4 is movable relative to the body 2 from a first position to a second position. In this embodiment the actuator 4 is slideable along the first axis 14 relative to the body 2.

In this figure the actuator 4 is shown in the first position relative to the body 2. The piston 50 is therefore arranged at a first end 53 (not shown in figure 2) of the piston chamber 24 (not shown in figure 2, but in figure 6) to define an air chamber 56 between the piston and a conduit end 54 of the piston chamber 24, the conduit end 54 comprising the conduit 28. In the first position the piercer 52 extends into the air chamber 56. In this embodiment the piercer 52 extends substantially along the first axis 14 from the piston 50. The first position will be described in more detail with reference to Figure 5.

Figure 3 shows the actuator 4 in more detail than in Figure 2. The actuator 4 comprises a piston 50, an actuator base 68, a piercer and an insert 76. The piston 50 includes a peripheral seal 58 adapted to engage, and form a sliding seal, with an interior of the piston chamber 24 of the body 2 (not shown in this Figure). The piercer 52 extends along a piercer axis 98 which when assembled with the dispenser 1 is substantially the same as the first axis 14. The piercer 52 comprises a seal surface 60 arranged between a release section 62 and a piercing end 64, the piercing end 64 being located at the free end of the piercer 52. The piercer 52 further comprises a root 66 which couples to an actuator base 68 using a snap fit coupling 70. The root 66 includes a flange 72 and the piston 50 includes a piston extension 74 which is trapped between the flange 72 and the actuator base 68 during installation. The finger engaging surface 20 of the actuator including an insert 76 is fitted into an opening of the actuator base 68. Figure 4 shows the powder container 30 in greater detail. A container flange 78 extends away from the outlet aperture 42 of the powder container 30 and its function will be described in more detail with reference to Figure 5.

Figure 5 shows the dispenser 1 with the actuator 4 in the first position relative to the body 2. The outlet part 6 is secured to the body 2 such that it covers the container chamber 26 and an inner shoulder 80 of the outlet part 6 secures the powder container 30 within the container chamber 26. The container flange 78 of the powder container 30 is trapped between an upper rim 82 of the container chamber 26 and the inner shoulder 80 of the outlet part 6. The outlet part 6 is coupled to the body 2 by a snap fit coupling once the powder container 30 has been arranged in the container chamber.

The piercer 52 extends from the piston 50 through the air chamber 56 and into the conduit 28, such that the piercing end 64 is adjacent the inlet seal 40 and the seal surface 60 is aligned with a seal portion 84 of the conduit 28, which in this case takes the form of a tube extending into the air chamber 56 substantially along the first axis 14 from a second end, or roof 94, of the air chamber 56.

The locking sleeve 18 and actuator 4 cooperate to provide a delivery lock. As the actuator 4 is assembled into the locking sleeve 18 (by sliding the actuator 4 into the locking sleeve 18 substantially along the first axis 14) a first hook part 86 provided on the actuator 4 moves past and then cooperates with a shoulder 88 of the locking sleeve to prevent removal of the actuator 4 from the locking sleeve 18. A resilient projection 90 from the actuator 4 engages an inwardly directed ridge 92 in the locking sleeve to resist movement of the actuator 4 further into the locking sleeve 18 until a threshold force is exceeded which resiliency deforms the projection 90 to allow it to pass the ridge 92, thereby allowing the actuator 4 to move further into the locking sleeve 18.

Figure 6 shows the dispenser 1 with the actuator 4 in the second position relative to the body 2. In this position the piston 50 has been moved within the piston chamber 24 to reduce the volume of the air chamber defined between the piston 50 and the roof 94. During movement of the actuator 4 to the second position, the piercing end 64 of the piercer 52 has been forced through first the inlet seal 40, the cavity 46 and then the outlet seal 44 to create an air path through the powder container 30. The air path is created by the annular air gap between the inlet and outlet apertures 38, 42 of the powder container 30 and the seal surface 60 of the piercer 52. The inlet and outlet seals 40, 42, once pierced, or otherwise breached, do not substantially prevent air flow. As the piercing end 64 is moved through the powder container 30 the seal surface 60 slides through the seal portion 84 of the conduit 28 maintaining a substantially fluid tight seal until the release section 62 reaches the seal portion 84. The fluid tight seal substantially prevents air from leaving the air chamber 24 as the volume of the air chamber 24 is reduced resulting in the air being compressed.

As the actuator 4 reaches the second position (as shown in Figure 6) the release section 62 reaches the seal portion 84 which removes the substantially fluid tight seal between the conduit 28 and the piercer 52 and allows air to pass from the air chamber 24 through the conduit 28, through the powder container 30 and out of the outlet opening 10 carrying entrained powder 48 with it. With the arrangement of the piercer, piston and conduit shown in these figures, air within the air chamber is pressurised during movement of the actuator from the first position to the second position and is only released once the piercer has pierced both the inlet and outlet seals 40, 42 of the powder container 30. Once released, the pressurised air flows through the conduit 28, through the powder container 30 and out of the dispenser 1 through the outlet opening 10. As the air flows through the powder container 30 at least some of the powder dose 48 therein is entrained in the airflow and is ejected from the dispenser 1 with the air. Since the amount of pressurisation and the timing of the subsequent release of the pressurised air from the air chamber 56 is controlled by the interaction of the piercer 52 with the conduit 28, the dispensing of powder from the dispenser 1 may be repeatable with a reasonable degree of consistency.

When the second position is reached, the locking sleeve 18 and the actuator 4 cooperate to provide a post-use lock. A resiliency deformable radial projection 95 of the locking sleeve snaps into a radial indent 96 on the actuator base 68. The post-use lock substantially prevents the actuator 4 from moving from the second position to the first position.

It will be understood that the delivery lock and the post-use lock shown in these Figures is simply an example of a possible embodiment of such locks and that a variety of means can be used to create this functionality. For example the projections and recesses could be provided on different parts, the two locks could be circumferentially offset from one another or additional parts could be used.

To assemble the dispenser 1, the actuator 4 is first assembled. The piston 50 is arranged on the actuator base 68 and the piercer 52 is snap fitted to the actuator base 68 to secure the piston 50 to the actuator base 68. The body 2 is then snap-fitted to the locking sleeve 18 by inserting the body 2 into a first end of the locking sleeve 18. The actuator 4 is then snap-fitted into the locking sleeve 18 by inserting the actuator 4 into a second end of the locking sleeve 18 opposite the first end.

A powder container 30 is then inserted into the container chamber 26 and the outlet part 6 is snap fitted onto the body 2 to secure the powder container 30 in place. The dust cap 8 is then fitted over the outlet part 6.

In each case, the step of coupling parts together, or inserting parts into one another, is achieved by moving the parts substantially along the first axis 14.

To use the dispenser 1, a user would remove the dust cap 8, place two fingers (typically the first to fingers of one hand) on the finger support surfaces 16 and one finger (typically their thumb) on the finger engaging surface 20. The user would insert the outlet part 6 into a nostril and then move their thumb towards their fingers, such that the actuator 4 is moved from the first position to the second position relative to the body 2 and the powder 48 from the powder container 30 is ejected from the dispenser 1 into the nostril and / or nasal cavity.

While specific language has been used to describe the disclosure, any limitations arising on account of the same are not intended. As would be apparent to a person in the art, various working modifications may be made to the method in order to implement the inventive concept as taught herein.

The drawings and the forgoing description give examples of embodiments. Those skilled in the art will appreciate that one or more of the described elements may well be combined into a single functional element. Alternatively, certain-elements may be split into multiple functional elements. Elements from one embodiment may be added to another embodiment. For example, orders of processes described herein may be changed and are not limited to the manner described herein.

Moreover, the actions of any flow-diagram need not be implemented in the order shown; nor do all of the acts necessarily need to be performed. Also, those acts that are not dependent on other acts may be performed in parallel with the other acts.

Benefits, other advantages, and solutions to problems have been described above with regard to specific embodiments. However, the benefits, advantages, solutions to problems, and any component(s) that may cause any benefit, advantage, or solution to occur or become more pronounced are not to be construed as a critical, required, or essential feature or component of any or all the claims.

The scope of embodiments is by no means limited by aforesaid specific examples. Numerous variations, whether explicitly given in the specification or not, such as differences in structure, dimension, and use of material, are possible. The scope of embodiments is at least as broad as given by the following claims.

Claims

CLAIMS:

1. A dispenser (1) for delivering powder, the dispenser (1) comprising:

a body (2),

a powder container (30),

an outlet (36) and

an actuator (4), wherein:

the body (2) defines a piston chamber (24) including a conduit (28) providing a fluid pathway to a container chamber (26), the container chamber (26) comprising the powder container (30);

the powder container (30) defines an internal volume within which a predetermined dose of powder is located and includes an inlet aperture (38) sealed by an inlet seal (40) at a conduit end (54) and an outlet aperture (42) sealed by an outlet seal (44) at an outlet end (36);

the powder container (30) is arranged in a fluid flow path between the conduit (28) and the outlet (36) such that fluid flow from the conduit (28) to the outlet (36) is substantially prevented by the inlet and outlet seals (40, 44) of the powder container (30); the outlet (36) comprises an outlet opening (10); and

the actuator (4) includes a piston (50) and a piercer (52) and is coupled to the body (2) such that the piston (50) is movable relative to the body (2) from a first position to a second position such that:

in the first position the piston (50) is arranged at a first end of the piston chamber (24) to define an air chamber (56) between the piston (50) and the conduit (28) and the piercer (52) extends into the air chamber (56); and

during movement of the actuator (4) from the first position to the second position the piston (50) moves within the piston chamber (24) away from the first end and towards the conduit (28), thereby reducing the volume of the air chamber (56), and the piercer (52) pierces the inlet seal and the outlet seal of the container (30) such that the air chamber (56) becomes fluidly connected to the outlet (36) by a flow path that extends through the conduit (28) and through the powder container (30) allowing fluid to pass from the air chamber (56) and through the outlet opening (10).

2. The dispenser (1) as claimed in claim 1, wherein the piercer (52) includes a piercing end (64) and a release section 62 with a seal surface (60) arranged therebetween, the piercer (52) being arranged such that during movement of the actuator (4) from the first position to the second position the piercer (52) moves through the conduit (28), and wherein a seal portion (84) of the conduit (28) forms a substantially fluid tight seal when aligned with the seal surface (60), but not when aligned with the release section (62), such that the piercer (52) substantially prevents fluid flow through the conduit (28) when the seal surface (60) is aligned with the seal portion (84) and permits fluid flow through the conduit (28) when the release section (62) is aligned with the seal portion (84), the arrangement being such that during movement of the actuator (4) from the first position to the second position, the seal portion (84) is first aligned with the seal surface (60) and then with the release section (62).

3. The dispenser (1) as claimed in claim 2, wherein when the actuator (4) is in the second position, the release section (62) is aligned with the seal portion (84).

4. The dispenser (1) as claimed in claim 2 or claim 3, wherein the piercer (52) extends along a piercer axis (98), the seal surface (60) is substantially cylindrical and has a first radius from the piercer axis (98) and the release section (62) includes regions which have a radial extent from the piercer axis (98) of less than the first radius.

5. The dispenser (1) as claimed in any of claims 2 to 4, wherein the piercing end (64) is tapered towards a point.

6. The dispenser (1) as claimed in any of claims 2 to 5, wherein during movement of actuator (4) from the first position to the second position, the piercing end (64) pierces both the inlet and outlet seals (40, 44) of the powder container (30) prior to the release section (62) becoming aligned with the seal portion (84?) of the conduit (28).

7. The dispenser (1) as claimed in any preceding claim, wherein in the first position, the piercer (52) extends from the piston (50) into the air chamber (56).

8. The dispenser (1) as claimed in any preceding claim, wherein the powder container (30) is a separate component arranged within the container chamber (26).

9. The dispenser (1) as claimed in any preceding claim, wherein the predetermined dose of powder comprises a predetermined dose of medicament for delivery to the nose or nasal cavity or mouth or oral cavity of a patient.

10. The dispenser (1) as claimed in any preceding claim, wherein the outlet (36) comprises an outlet part (6) which extends over the container chamber (26) and includes the outlet opening (10).

11. The dispenser (1) as claimed in claim 10, wherein the outlet part (6) is shaped for insertion into the nostril of a user.

12. The dispenser (1) as claimed in claim 10 or claim 11, wherein the outlet part (6) is a snap fit to the body (2) and secures the powder container (30) within the container chamber (26).

13. The dispenser (1) as claimed in any preceding claim, wherein a locking sleeve (18) is provided to which the body (2) and actuator (4) are snap fitted during assembly of the dispenser (1) to thereby couple the body (2) to the actuator (4).

14. The dispenser (1) as claimed in claim 13, wherein the body (2) and actuator (4) are retained in the first position by a delivery lock, provided by the locking sleeve (18), which prevents separation of the body (2) and actuator (4) and which allows movement of the actuator (4) towards the second position once an actuation threshold resistance has been overcome.

15. The dispenser (1) as claimed in claim 13 or 14, wherein the locking sleeve (18) provides a post-use lock which is activated when the actuator (4) reaches the second position and substantially prevents the actuator (4) from moving from the second position to the first position.

16. The dispenser (1) as claimed in any preceding claim, wherein the piercer (52) coupled to the actuator (4) using a snap fit connector.

17. The dispenser (1) as claimed in claim 16, wherein the piston (50) is arranged between the piercer (52) and actuator (4) such that coupling of the piercer (52) to the actuator (4) secures the piston to the actuator (4).

18. The dispenser (1) as claimed in any preceding claim, wherein the dispenser (1) includes a dust cover which substantially covers the outlet (36).

19. A method of assembling a dispenser (1) for delivering powder to the nose, the dispenser (1) comprising, a body (2), a powder container (30), an outlet (36) and an actuator (4), the dispenser (1) being substantially as described in any preceding claim, and the method of assembly including the steps of:

coupling the body (2) to the actuator (4);

arranging a powder container (30) in the container chamber (26);

securing the powder container (30) in the container chamber (26) by securing an outlet (36) to the body (2).

20. The method of assembling a dispenser (1) as claimed in claim 19, wherein the method step of coupling the body (2) to the actuator (4) comprises using a snap fit coupling to couple the body (2) to the actuator (4).

21. The method of dispensing a powder dose from a dispenser (1), the dispenser (1) being substantially as claimed in any of claims 1 to 18, wherein the method comprises the steps of:

moving the actuator (4) towards the second position;

causing the piercer (52) to pierce the inlet (40) and outlet (44) seals of the powder container (30); and

causing air to flow from the air chamber (56), through the powder container (30) and out of the outlet opening (10), the airflow entraining powder from the powder container (30) and carrying it through the outlet opening (10).