MXPA06004218A - Inhaler - Google Patents

Abstract

An inhaler (1) is disclosed. It comprises a housing (2) to receive a strip (6) of blisters (6a) each having a puncturable lid (6c) and containing a dose of medicament for inhalation by a user, a mouthpiece through which a dose of medicament is inhaled by a user and, an actuator (3) operable to sequentially move each blister into alignment with a blister piercing member (7, 9). The actuator is also operable to cause the blister piercing element to puncture the lid of a blister such that, when a user inhales through the mouthpiece, an airflow through the blister is generated to entrain the dose contained therein and carry it out of the blister and via the mouthpiece into the user's airway.

Description

INHALER DESCRIPTION The present invention relates to an inhalation device for the oral or nasal distribution of medicament in powder form. The invention also relates to an inhaler containing a strip of blister packs each having a pierceable lid and containing a dose of medicament for inhalation by a user of the device according to the invention and, to a method of using such a device. . Oral or nasal administration of a medicament using an inhalation device is a particularly attractive method of drug administration since these devices are relatively easy for a patient to use discreetly and in public. As well as the administration medication to treat local diseases of the respiratory tract and other respiratory problems, these have also been used more recently to use drugs to the blood stream via the lungs, thereby avoiding the need for hypodermic injections. In a conventional type of metered dose inhalation device, the powder medication is maintained in a reservoir within a dispensing device that is operable to measure and supply a predetermined amount of powder for each dose. However, these devices suffer from poor dose-measuring capability, especially when the dose size is relatively small, since it is difficult to accurately measure small amounts of dry powder in such a device. It is also difficult to protect the drug from entering the unit and seal it from the atmosphere until it is required for administration to a patient. It is common for dry powder formulations to be prepackaged in individual doses, usually in the form of capsules or blisters, which each contain a single dose of the powder that has been accurately and consistently measured. A blister is generally cold formed from a ductile sheet laminate or a plastic material, and includes a pierceable lid that is permanently heat sealed around the periphery of the blister, during fabrication and after introduction of the blister. dose inside the blister. A metallic foil blister is preferred over the capsules, since each dose is protected from the ingress of water and the penetration of gases such as oxygen, as well as being protected from light and ultraviolet radiation, all of which may have a harmful effect on the administration characteristics of the inhaler, if a dose is exposed to them. Therefore, a blister offers excellent environmental protection at each individual drug dose. Inhalation devices that receive a blister pack comprising a number of blisters each containing a pre-measured and individually packaged dose of the drug to be dispensed are known. The actuation of the device causes a mechanism to open a blister, so that when the patient inhales, the air is pulled through the blister by dragging the dose into it, which is then carried from the blister through the device and through the channels of the patient, to the lungs. It is advantageous that the inhaler be able to maintain a number of doses to make it possible for it to be used repeatedly over a period of time, without the requirement of opening and / or inserting a blister into the device, each time it is used. Therefore, many conventional devices include means for storing a blister number, each containing a single dose of the medicament. When a dose is to be inhaled, an indexing mechanism moves a blister previously emptied away from the opening mechanism, So a fresh dose is moved to a position ready to be opened for inhalation of its contents. A problem with conventional inhalation devices is that they are relatively large, heavy and difficult to operate. Despite their large size, many of them only have sufficient capacity to retain a relatively small number of doses before the device needs to be opened, and a new blister group mounted on it. Although it may be possible to increase the number of blisters by making them smaller, this can only be achieved at the expense of reducing the dose load or capacity of each blister. This is particularly disadvantageous when the device is to be used to distribute for example less potent, newer drugs, where each blister must be able to maintain a load in the range of 10 to 20 mg of the drug. Due to their nature and method of operation, conventional inhalation devices have a relatively complicated construction and consist of many separate components that make them difficult and time consuming to assemble, as well as expensive to manufacture and purchase. A conventional inhalation device of the type described above is known from the Patent of United States No. 4,811,731. This device is configured to receive a disc-shaped dose storage blister pack in which the doses are arranged in a generally circular pattern. A plunger is provided which moves in response to the actuation of a lever to pierce a blister placed thereunder, to enable the dose to be inhaled from the perforated blister. The device also includes a separate indexing or indexing device operable to rotate the disc, to move a fresh blister towards a pierceable position. A significant problem with this device is that the number of doses is severely limited. As can be seen from the device shown in the Figures, it is capable of receiving only eight doses at a time, so frequent disc replacement is necessary. Although it will be appreciated that the disk may be made larger to accommodate a larger number of blisters, this could result in a significant increase in the overall size of the device, making it very bulky. It is also notable that the perforation and alignment steps are completely controlled independently of one another making the device significantly more difficult to use and increasing the number of components that make up the device.

Another known inhalation device is described in U.S. Pat. 6,032,666. Although this device receives a strip of blister packs, it has a very complicated construction with numerous components, which make it difficult to assemble and operate. This is limited by the fact that access to the dose contained in each blister is obtained by detaching the lid instead of perforating it. Therefore, the device has a complicated mechanism for detaching the blister lid, including a pick-up reel for the detached lid strip, and a complete clutch arrangement to ensure that the same length of lid is detached from each strip, each Once the device is used, as more and more of the lid strip is wound around, the pickup reel. These components, together with the requirement to store the detached lid inside the device, increase its complexity and full size, as well as make it more difficult to fill with a fresh strip of blister packs. It will also be appreciated that this device can only be used with a strip of blister packs in which the lid is releasably attached to the blister. Not only does this require a suitable adhesive, it also reduces the barrier to moisture and other environmental contaminants.

The present invention seeks to provide an inhalation device that overcomes or substantially alleviates problems with conventional inhalation devices of the type discussed above. In particular, the invention seeks to provide a device having a significantly simpler construction of the known devices, which is capable of storing a relatively large number of blisters that are also capable of holding a large load, without any significant increase in the full size Of the device. The inhalation device of the present invention should also be much easier to process, assemble and operate, as well as be cheaper to manufacture. According to the invention, there is provided an inhaler comprising a housing for receiving a plurality of blister packs, each having a pierceable lid and containing a dose of medicament for inhalation by a user, a mouthpiece through which it is a dose of the medicament is inhaled by a user and, an operable actuator for sequentially moving each blister in alignment with a blister puncturing member, the actuator is also operable to cause the blister puncturing member to pierce the lid of a blister, such that when a user inhales through the buccal piece, a flow of air is generated through the blister, to drag the dose contained in it, and to take it out of the blister and via the mouth piece towards the user's airways. In a preferred embodiment, the actuator is pivotably mounted to the housing and may comprise an arm that can be pivotably mounted to the housing at one end. The blister piercing member may comprise a pair of piercing heads depending on one side of the arm positioned to extend through the opening in the housing in a closed position, in which the arm lies substantially against the housing, for pierce the lid of a blister aligned with the opening. Each drilling head may preferably comprise a primary cutting element, and a pair of secondary cutting elements extending laterally through each end of the primary cutting element. Conveniently, the primary cutting element and the secondary cutting elements each have a sharp tip, the tip of the primary cutting element extends beyond the tips of each of the secondary cutting elements. Ideally, the secondary cutting elements are parallel to each other, and extend at right angles to the primary cutting element, although the secondary elements do not need to be parallel and could extend from the primary cutting element to any convenient angle. In a preferred embodiment, an opening is formed in the arm in the vicinity of each piercing head, at least one of the openings forms an air flow inlet towards a blister, and at least one other opening forms a flow outlet of air from the blister. Conveniently, the secondary cutting elements are raised from the edge or the periphery of the opening in the arm, and the primary cutting element extends through the opening and joins each of the secondary cutting elements together. Advantageously, the buccal piece is on the arm and extends in a direction opposite to the direction in which the piercing heads extend, the openings in the arm being in communication with the internal part of the buccal piece. In one embodiment, the mouthpiece, the arm and the piercing heads are integrally formed, although the piercing heads may also be formed on a separate piercing module that is removably mountable on the arm, or is at least separately coupled to the arm. during manufacturing.

The buccal part preferably includes a primary chamber having an external air inlet in communication, via the primary chamber, with the or each air flow inlet opening in the arm and, a secondary chamber in communication with the or each air inlet opening. airflow outlet in the arm such that when a user inhales through the mouthpiece, the air is pulled through the or each airflow inlet opening towards the blister via the external air inlet, and the primary chamber to drag the dose into the air flow, the dragged dose passes through the or each of the airflow outlet openings to the secondary chamber of the mouthpiece, from where it is brought into the respiratory tract of the user. A dividing wall can separate the primary and secondary chambers within the buccal part, and at least one air diversion opening can extend through the dividing wall to communicate the primary chamber with the secondary chamber. Since air can pass directly from the primary chambers to the secondary chamber when a user inhales, in addition to passing through the blister, the effort required to inhale through the mouthpiece is reduced. The or each deflection opening can be configured such that the air flow from the primary chamber towards the secondary chamber, through the or each opening deviation, and the air flow from the or each of the airflow outlet openings, are substantially at right angles to one another. Since the flow is at an angle, the degree of turbulence is increased, which helps in the deagglomeration of the dose and the creation of an inhalable aerosol. In a preferred embodiment, the inhaler includes an indexing or alignment mechanism that includes an alignment member that moves to move a blister in alignment with the blister puncturing member. More preferably, the alignment member is a wheel that rotates to move a blister in alignment with the piercing member of the blister. However, it is also considered that other arrangements are possible such as, for example, a mechanism incorporating a sliding or alternating movement member. In a preferred embodiment, the inhaler is configured so that the alignment of the blister strip occurs when the actuator is pivoted in one direction and the perforation of a blister occurs when the blister is rotated in the opposite direction. However, the device can also be configured so that the alignment wheel rotates, to move a blister in alignment with the blister piercing member, in response to rotation of the actuator with respect to the housing in one direction, movement of the actuator in the same direction is also operable to pierce the lid of a blister aligned with the blister piercing member . Preferably, the alignment wheel and the actuator include a means of cooperation thereon, which engages when the actuator is rotated in a direction to cause rotation of the alignment wheel. In one embodiment, the cooperation means comprise a group of detent teeth on the alignment wheel and a driving pawl on the actuator. Advantageously, the means depend on the housing to substantially prevent rotation of the different alignment wheel by the movement of the actuator in one direction. In one embodiment, the means comprises a first elastically deformable anti-rotation pawl on the housing, which extends towards one of the recesses in the alignment wheel, the actuator includes the means for deflecting the first anti-rotation pawl from the hollow, to allow rotation of the alignment wheel when the drive ratchet engages with the detent teeth. The actuator may include a drive plate and means on the actuator for deflecting the first anti-rotation pawl, comprising a release peg erect from the drive plate, which engages and elastically deflects the pawl out of the recess to allow the rotation of the alignment wheel. The inhaler may also comprise a second elastically deformable anti-rotation pawl on the housing, and a cam member on the actuator, the cam member engages with a cam surface on the second anti-rotation pawl when the first Anti-rotation ratchet is desired outside a gap to prevent rotation of the alignment wheel through more than a predetermined angle. The inhaler may include a cap coupled to the housing, pivotable between a closed position in which it covers the actuator and the mouthpiece, and an open position in which the actuator and the mouthpiece are disclosed to enable a user to inhale through the mouth piece. In yet another embodiment of the invention, the alignment wheel rotates to move a blister in alignment with the blister perforation member, in response to the rotation of the lid with respect to the housing from the open position to the closed position. This embodiment simplifies the operation of the device in addition by providing that the perforation and alignment steps are performed in response to the opening and closing of the lid that is located on the mouthpiece. Preferably, the cap and the actuator include cooperating means for coupling the actuator to the cap, such that the actuator rotates relative to the housing in response to rotation of the cap between the open and closed positions. The cooperating means may comprise a cam guide slot on the lid, and a follower cam on the actuator, slidably positioned within the cam guide slot. Ideally, the cam guide slot is shaped such that when the lid is rotated from its closed position to its open position, the cam follower travels along the cam guide slot to rotate the actuator, and cause the cam follower to rotate. the blister punching member pierces a blister lined with it, and the opening, and when the lid is rotated from its open position to its closed position, the cam travels back along the cam guide slot to cause the actuator rotates in the opposite direction and removes the piercing member from the blister. Besides, the Cam guide slot can be configured such that the actuator does not rotate directly until the end of the cam movement from its closed position to its open position, and rotates at the beginning of the movement of the lid from its open position to its closed position. In a preferred arrangement, the alignment wheel and cover each include a toothed gear member mounted thereon, engaged such that rotation of the cover between the open and closed positions causes rotation of the gear member on the alignment wheel. . A clutch member preferably engages the engagement member on the alignment wheel towards the alignment wheel, such that the alignment wheel rotates together with the engagement member coupled thereto, when the cap is rotated from the open position towards the position. closed, to move a subsequent blister in alignment with the piercing member of the blister. The housing advantageously includes a chamber for receiving the blisters used. The chamber can be subverted by a cover attached to the housing, which can be opened to facilitate the removal of a portion of the used blister, the blister remaining in the device.

In one embodiment, a separating element is mounted on the housing, which is operable to make it possible to detach the portion of the blisters used. The separating element preferably includes a blister handle, elastic, which is operable to press a strip of blister packs against the housing, to facilitate separation of said portion from the remaining blister packs. The inhaler according to the invention can also incorporate a rolled strip of blister packs, each containing a pierceable lid, and containing a dose of medicament for inhalation by a user, located in the housing. According to the invention, there is provided a method for using an inhaler according to the invention, including the step of rotating the actuator to move a blister in alignment with a blister perforation member in the housing, and to pierce the cap of a blister aligned with the blister piercing member and, inhaling through the mouthpiece to generate an air flow through the blister, to draw the dose contained therein and carry it through the opening and via the piece mouth to the user's airway.

The step of rotating the actuator can include the step of turning it in a first direction, to pierce the lid of a blister aligned with the blister puncturing member and, once the inhalation step is completed, the rotation thereof in a second direction for moving a subsequent blister in alignment with the blister punching member in the housing. In addition, the step of rotation of the actuator may comprise the step of rotating a cover coupled to the actuator. According to yet another aspect of the invention, there is provided an inhaler comprising a housing for receiving a blister having a pierceable lid, and containing a dose of medicament for inhalation by a user, the device comprising a piercing head for piercing the lid of a blister, so that the dose contained therein can be inhaled by the user from the blister through the device, wherein the piercing head comprises a primary cutting element which is configured to cut, according to the head of the blister. perforation enters the blister, a first linear slot in the lid and, the secondary cutting elements which are laterally understood from the primary cutting element which are configured to cut, as the perforating head continues to enter the blister, second linear slits which are extend through each end of the first. Linear slit formed by the primary element, the primary and secondary elements together form a pair of flaps in the lid, which are folded aside by the drilling head after the additional entry of the drilling head into the blister. The inhaler may be able to receive only a simple blister. However, in a preferred embodiment, it receives a strip of blister packs each containing a dose of medicament. In this case, the inhaler may include a mechanism for indexing or aligning blister strips, such as those described with reference to other embodiments of the invention, which is operable to cause the blister strip to sequentially align the blisters at a position in which each blister will be drilled by the drill head. In a preferred embodiment, the drill head comprises a pair of secondary cutting elements. The secondary cutting elements may be spaced apart from each other and the primary soot element is shown on and extends between the pair of secondary cutting elements. Preferably, the primary cutting element is formed from a blade, the plane of the blade lies substantially at right angles to a busy plane by the lid of a blister, which is located in the inhaler in a position ready for perforation. The primary cutting element advantageously has a sharp edge for cutting the first linear groove in the blister lid. The edge may taper towards a sharp point which may be located midway between the secondary cutting elements. The secondary drilling elements are positioned so that they each extend laterally through either end of the primary drilling element. Each of the secondary drilling elements can be formed from a blade, the plane of the blade lies substantially at right angles to the plane of the blade, forming the primary drilling element, and right angles to the lid of a localized blister in a drilling position. As with the primary piercing element, each of the secondary piercing elements may have a sharp edge to cut the second linear grooves in the lid of a blister. The edge of each of the secondary drill elements tapers towards a sharp point.

In a preferred embodiment, the sharp tip of each of the secondary drill elements lies in the plane occupied by the primary drill element. Conveniently, the sharp tip of each of the secondary drilling elements lies at the same height as the primary drilling element, at the point at which the primary drilling element and the secondary drilling element meet one with the other. other. In yet another embodiment, the primary cutting element divides each secondary cutting element into first and second cutting members that extend laterally from opposite sides of the cutting element. primary. Preferably, the first and second cutting members converge towards each other at an angle and the primary element is raised from the part of the secondary cutting members from a point on each cutting element. . secondary, in which the first and second cutting members meet. The secondary cutting elements can be angled inwards toward each other, to assist in the formation and folding of the flaps in the cover of the blister as the drill head enters the blister.

The inhaler preferably comprises a pair of piercing heads that rise from a piercing member. Preferably, the primary and secondary cutting elements are integrally molded in one piece. In a preferred embodiment, the secondary cutting elements extend laterally from the primary cutting element at a 90 degree angle to the primary cutting element. However, it is also considered that the secondary cutting elements can extend laterally from the primary cutting element at an angle less than, or greater than 90 degrees. The primary cutting element preferably divides each of the secondary cutting elements into the secondary cutting members which extend laterally from the primary cutting elements by different distances, so that the flap cut in the lid of a blister by the members Secondary cutting edges extending laterally from one side of the primary cutting element, is of a size different from the flap cut in the blister by the secondary cutting members extending laterally from the other side of the primary cutting members. According to any of the embodiments of the invention, the piercing member may comprise a discrete drilling module which is molded separately, and subsequently subsequently coupled to the actuator either permanently during assembly, or so that it can be removed from the actuator by the user for replacement, if necessary. The piercing module preferably comprises a main body portion with first and second piercing heads that rise from it. Preferably, an air inlet and an air outlet opening extend through the main body portion of the piercing module, one of the piercing heads which depends on the periphery of the air inlet and which extends over the air inlet, and the other drilling head that depends on the periphery of the air outlet, and that extends over the air outlet. The main body portion may include a recessed region around the air inlet, the drill head depending on the periphery of the air inlet from the recessed region. The air outlet opening is preferably in communication with an air outlet pipe that extends from the main body in a direction opposite to the drill head that is extends from the periphery of the air outlet opening. In a preferred embodiment, the air outlet tube comprises axially extending ridges, formed on its external surface, which place the piercing head inside a hollow with walls in the mouthpiece. A space formed between the flanges and the recess with walls advantageously comprises a diversion air conduit for the direct flow of air towards the mouthpiece from the external part., when a patient inhales through the mouthpiece. In a preferred embodiment, the alignment mechanism comprises a blister strip placement frame defining a path for the blister strip, beyond the opening in the housing. Preferably, an elastically deformable arm extends from the blister strip attaching frame and the alignment mechanism comprises an alignment wheel rotatably mounted to the free end of the elastically deformable arm on which a blister strip is passed. The alignment wheel may comprise a group of spokes, and the actuator includes a drive tooth engageable with a first beam, when the actuator is pivoted relative to the housing to an open position, to cause the alignment wheel to rotate together with the actuator to align the blister strip. Preferably, the inhaler includes an anti-rotation ramp on the housing, which is engaged by yet another ray of the alignment wheel, when the alignment wheel rotates thereby causing the arm to deform to allow the beam to clear the anti-rotation ramp, returning the arm to its non-deformed state once the beam has cleared the ramp, thereby preventing rotation of the alignment wheel to the opposite direction. Preferably, the driving tooth on the actuator is formed such that, when the actuator is rotated in the opposite direction from its open position towards its closed position, the driving tooth slides on the upper part of the preceding spoke of the driving wheel. alignment. Conveniently, the edge of each beam is shaped to allow the driving tooth to pass over it when the actuator is pivoted from its open position to its closed position. In one embodiment, the positioning ramp may be placed adjacent to, but separated from the anti-rotation ramp. In this case, the drive tooth may be operable to cause the arm to deform elastically as the drive tooth slides over the top of the beam, to cause another beam of the alignment wheel to extend into the space between the anti-rotation and positioning ramps, and to prevent rotation of the alignment wheel In any direction. The embodiments of the invention will now be described, by way of example only, with reference to the accompanying drawings, in which: Figure 1 is a perspective view of an inhaler according to an embodiment of the invention; Figure 2 is a perspective view of the inhaler illustrated in Figure 1, with the lid open to reveal the mouthpiece and the actuator in a closed position; Figure 3 is a perspective view of the inhaler illustrated in Figure 2, with the actuator in an open position; Figure 4 is a perspective view of the inhaler shown in Figure 1, with a used, open blister chamber cover; Figure 5 is an exploded perspective view of the inhaler illustrated in Figures 1 to 4, showing also a rolled strip of blister packs, used with the device according to the invention; Figure 6 is a rear cross-sectional view of the inhaler illustrated in Figures 1 to 5 with the actuator shown separately; Figure 7 is a front cross-sectional view of the inhaler illustrated in Figure 6, in which the actuator is pivotably mounted to the housing; Figures 8A and 8B show the configuration of the piercing elements on the actuator, and a small portion of a blister strip to illustrate the type of cut made therein by the piercing elements, respectively; Figure 9 is a side sectional view of the buccal part and the actuator during inhalation of a blister; Figures 10A to 10C show a series of frontal cross-sectional views of the inhaler according to the invention, with a strip of blisters located therein to show the path of the blisters used, from the housing. Figure 11 is an exploded side cross-sectional view of an inhaler according to another embodiment of the invention; Figures 12A and 12B are side cross-sectional views of the inhaler according to the second modality, with the lid in the closed and open positions, respectively; Figure 13 shows a short portion or strip of blister packs for use in the inhaler according to any embodiment of the invention; Figures 14A and 14B are perspective views of other embodiments of inhaler according to the present invention; Figures 15A and 15B show a cross-sectional side view of the inhaler illustrated in Figures 14A and 14B, with the actuator in a closed and open position, respectively; Figure 16 is another cross-sectional side view of the inhaler shown in Figures 14A and 14B; Figure 17 is a side sectional view of the mouthpiece and the actuator during inhalation from a blister; Figure 18 shows an alternative configuration of the piercing elements on the actuator according to any embodiment of the invention, and Figure 19A shows the air flow to the blister using the piercing elements of Figure 8A and Figure 19B, that show the air flow towards the blister using the piercing element of Figure 18; Figure 20 illustrates a perspective view of another embodiment of the inhaler according to the present invention, with the lid open, and the actuator in the closed position, in which it lies against the housing of the inhaler; Figure 21 illustrates a perspective view of the inhaler shown in Figure 20, but after the actuator has been pivoted with respect to the body to an open position; Figure 22 illustrates another perspective view of the inhaler shown in Figures 20 and 21, with a strip of used blisters protruding from the housing, and a blister door used in an open position; Figure 23 illustrates a side view of the inhaler shown in Figures 20 to 22, with one half of the housing omitted, so that the internal components are visible together with a rolled strip of blister packs, located in the housing, the actuator is shown detached -of the housing and the cover of the used blister is omitted for clarity; Figure 24 illustrates a perspective, partly exploded view of the inhaler shown in Figures 20 to 23; Figure 25 illustrates a perspective, fully exploded view of the inhaler shown in Figure 24; Figures 26A to 26E each illustrate an enlarged portion of the inhaler shown in Figure 23, and show the various positions of the alignment wheel during operation of the device; Figure 27 illustrates a perspective view of a drill head module, mainly intended for use with the embodiment described with reference to Figures 20 to 27, but which may also be used with any of the previously illustrated embodiments; Figure 27A illustrates a side view of the drill head module shown in Figure 27; Figure 27B illustrates an end view of the piercing head module shown in Figures 27 and "27A; Figure 28 illustrates a perspective view of the actuator used with the embodiment shown in Figures 20 to 26, with the head module perforation of Figure 27 mounted thereto; Figure 29 is a side sectional view to show the passage of air through the drill head module of Figure 27, and Figure 30 is a side view of an inhaler having an endless loop actuator according to another embodiment of the invention, with one half of the housing removed to reveal the internal components. A first embodiment of the inhaler according to the invention will be described with reference to Figures 1 to 10. This embodiment provides a simple, easy-to-use inhalation device that aligns and punctures the blister using the same actuator. In addition, the actuator aligns and punches a blister during the same stroke or direction of rotation of the actuator. Referring now to the drawings, there is shown in Figure 1 an inhaler 1 according to a first embodiment of the invention, comprising a housing 2 to which an actuator 3 is pivotably mounted. A cover 4 is integrally hinged to the upper edge of the housing 2, and is pivotable between a closed position, as shown in Figure 1, to an open position, as shown in Figure 2, to have access to a buccal piece 5 integrally formed with and rising from the actuator 3. The lid 4 completely covers and protects the mouthpiece 5 when closed, and prevents contamination thereof or possible ingress of the powder into the housing 2, which could otherwise be inhaled when the device is used.

The inhaler 1 is intended for use with a strip 6 of moisture-proof blister packs (see Figure 13) each containing a pre-determined dose of the powdered medicament for inhalation. Each blister 6a in the strip 6 comprises a bag 6b of generally hemispherical shape and a flat perforable lid 6c permanently sealed by heat to the bag 6b to hermetically seal the dose therein. The strip 6 is preferably made of sheet metal laminate or a combination of sheet metal laminate, such as aluminum, and plastic material. In a preferred embodiment, the blisters consist of a base and a lid. The base material is a laminate comprising a polymeric layer in contact with the drug, a layer of mild hardened aluminum and an outer polymeric layer. Aluminum provides the barrier to moisture and oxygen, while the polymer provides a relatively inert layer in contact with the drug. Soft tempered aluminum is ductile, so that it can be "cold formed" in a blister form. This is typically 45 μm thick. The outer polymeric layer provides additional stiffness to the laminate. The cap material is a pierceable laminate comprising a heat seal lacquer, a layer of hard laminated aluminum (typically 20 to 30 μm thick) and an outer lacquer layer. The seal lacquer by heat bonding to the polymeric layer of the base sheet laminate during heat sealing. The materials for the polymeric layer in contact with the drug include polyvinyl chloride (PVC), polypropylene (PP) and polyethylene (PE). In the case of PE, the heat seal lacquer on the metal foil lid is replaced with an additional layer of PE. After heat sealing, the two PE layers are melted and welded together. The outer polymer layer on the base sheet is typically oriented polyamide (oPA). The actuator 3 comprises a lever arm 7 having one end pivotably mounted to the housing 2, to enable it to rotate from a closed position shown in Figures 1, 2 and 4 to an open position shown in Figure 3. As shown in FIG. can observe from Figure 3, the housing 2 has an opening 8 therein for receiving a piercing member comprising a pair of piercing heads 9, extending from the lever arm 7, when the actuator 3 is in a closed position, and penetrates the lid 6c of a blister located within the housing 2 immediately behind the opening 8. The shape of the piercing heads 9, will now be described with reference to Figure 8A. This is important because the openings that are made in the lid 6c of a blister 6a must be of sufficient cross sectional area and of sufficient shape to promote the free flow of air through the blister 6a, and to ensure that the entire internal volume of the blister 6a is swept by the air flow and consequently that all or substantially. all, the dose is carried and carried out of the blister 6a. Each drilling head 9 comprises a generally "H" shaped element having a central tooth in the form of a flat blade, or primary cutting element 10, and a pair of flat teeth in the form of a flat blade or secondary cutting elements. 11, which extend laterally through each end of the primary cutting element 10. Each of the primary and secondary cutting elements 10, 11 tapers toward a sharp tip. The sharp tip 10a of the primary cutting element 10 may be located at its center, for example halfway between the secondary cutting elements 11. However, it may be advantageous to form a primary cutting element 10 so that its sharp tip 10a is closer to one of the secondary drilling elements 11 than the other secondary cutting element 11, for example in order to facilitate correct drilling, when the approach angle of the drilling heads 9 is not normal to the leaf . The height of each of the secondary cutting elements 11 is such that the Sharp tips of the secondary cutting elements 11 are at the same height as the edges of the primary cutting element 10, when the primary and secondary cutting elements 10, 11 meet one another. The sharp tip 10a of the primary cutting element 10a is therefore above the sharp point Ia of each of the secondary cutting elements 11, so that the primary cutting element 10 divides, or has initiated at least, the first division or linear slit in the blister before the secondary cutting elements 11 begin to cut the second linear slits in the blister. The upper edges of each of the primary and secondary cutting elements 10, 11 are shaped to enable them to easily penetrate and cut the lid 6c of a blister 6a. As can be seen in Figure 8A, the secondary cutting elements 11 of each drill head 9 are raised from the opposite edges of an opening 12 in the lever arm 7, to make possible the flow of air through the arm 7. in and out of the blister 6b via the holes made in the lid 6c of the blister 6b with the piercing members 9. The primary cutting element 10 is coupled to, and is supported between, each of the secondary cutting elements 11. , and the primary cutting element extends through the opening 12 and thus it is not directly blown to the lever arm 7. Figure 8B illustrates a short section of a strip 6 of blister packs 6a, to show the shape and size of the openings that each of the elements of drilling 9 described with reference to Figure 8A, cut into the lid 6c of a blister 6b. The primary cutting elements penetrate the lid 6c first (point A in Figure 8B) and, as they enter the blister 6a, two linear cuts or slits are made by each of them, as indicated by the arrows "B". As the drill head further enters the blister, the secondary cutting elements 11 penetrate the blister 6a and linear cuts are also made at each end of the linear cuts perpendicular to the first linear cut formed by the primary drilling element 10, as indicated by the arrows "C". These cuts have the effect of creating flaps 12a that are folded back into the blister 6a as the piercing head 9 further enters the blister. These drilling heads 9 are capable of forming openings that extend by more than 30 to 50% of the surface area of a lid 6c of a blister 6a. For example, in the embodiment of Figure 27, the blister lid area is 67 mm2 and the perforations open an area of 29 mm2 that is equivalent to 43% of the surface area of the lid. As shown in Figure 4, a cover 13 is pivotably coupled to the side of the housing 2 and encloses a space for receiving the used blister packs 6d which are fed into the space through a slot 14 in the wall of the housing 2. The space inside the cover 13 is large enough to accommodate only a few blisters used 6d therein, and thus an elastically flexible blister holder 15 extends from the housing 2 and facilitates the removal of some of the used blisters 6d from the blisters 6 remaining in the housing 2. To remove a section of the used blister packs 6d, the blister handle 15 is pressed against the strip 6 to sandwiched between the blister holder 15, and the side wall of the housing 2. The visible section of the used 6d blisters can then be held by hand, torn and discarded without accidentally placing undue force on the remaining part of the blister strip 6 which could tend to pull it out of the housing 2. Figures 10A to 10C show three front views in cross-section through the inhaler 1. In Figure 10A, there are no empty blisters 6d protruding through of slot 14. In Figure 10B, the device has been activated two more times and thus two empty blisters 6d have now passed through the slot 14. In Figure 10C, the blister handle 15 has been pressed against the housing 2 in the direction of the arrow "A" for make it possible for two empty blisters 6d to be detached by pulling them in the direction of arrow "B". It will be appreciated that a cover 13 is not essential, and the blisters used 6d can be removed as soon as they emerge from the opening 14 in the wall of the housing 2. In still another embodiment, the inhaler 1 can be provided with a cutting implement (np shown) such as a blade or serrations against which the section of the blisters used 6d is to be removed, can be pressed to facilitate its detachment. In a preferred arrangement, a blade can be mounted and extended from the blister handle 15, so that when it is pressed against the housing 2, it cuts the strip 6 located between the blister grip 15 and the housing 2. In another more mode, the inhaler 1 can incorporate a larger chamber, possibly with a catchment reel around which the used 6d blister strip can be rolled, so that this can be removed as a whole from the device, and thus avoid the need to detach sections of strip 6d according to each short section of blister packs 6a is used. However, in order to keep the device as small as possible, it is preferable to provide an array in which at least some of the blisters used 6d can be easily removed from the device, while unused blisters remain therein. Referring now to Figure 5, the housing 2 comprises a generally cylindrically shaped chamber 20 for receiving a wound or rolled strip of blister packs 6, each containing a pre-measured dose of medicament to be dispensed using the inhaler 1. front end 6c of the strip 6 is received in the blister feed inlet path 21, which opens upward in a cavity 22 generally cylindrical, adjacent to and in communication with the opening 8 in the housing 2, and in which An alignment wheel 23 is rotatably received. A used blister feed outlet path 30 extends from the cylindrical cavity 22 and leads to the opening 14 in the wall of the housing 2. The chamber 20 has a cover (not shown in FIG. Figure 5) that forms part of the housing 2. Preferably, the cover is removably coupled to the rest of the housing 2, to allow access to the internal part of the inhaler 1, to be obtained, and to make it possible for a new strip 6 of blister packs to be inserted therein. However, it is considered that the device could form a detectable unit, in which case a blister strip 6 could be mounted on the device during assembly, and the cover permanently attached, so that once the strip has been exhausted, the entire device is detached. The simplicity of the construction of the device and the relatively few separate components makes the device very cheap to manufacture and thus a disposable unit is a viable proposition. The alignment wheel 23 is generally a cylindrically shaped member with a group of notches or recesses 24 for receiving blister packs, which extends longitudinally along its outer surface parallel to its axis of rotation. Each notch 24 is formed to thereby receive a blister 6a thereon, as the alignment wheel 23 rotates, as will be explained in more detail below. The recesses 24 are spaced at a spacing that is equal to the distance "d" between the center lines of a pair of blister packs, as indicated in Fig. 13, so that as the alignment wheel 23 rotates, a strip 6 which extends through the blister feed path 21 and over the wheel alignment 23, is pulled so that a blister 6a is placed in the recess 24 of the alignment wheel 23, located immediately opposite the opening 8, as will be explained in more detail below. To enable the alignment wheel 23 to rotate in response to rotation of the actuator 3 in one direction, the detent teeth 25 are formed on an end face thereof, for cooperation with the actuator 3, as will be briefly explained, each tooth 25 comprising an arched section 26 of ramp and a shoulder 27. The alignment wheel 23 is a narrow fit in the cylindrical cavity 22, so that the strip 6 is held securely by the alignment wheel 23 , and each blister 6a is tightly received and maintained in the recess 24 opposite the opening 8, while allowing the rotation of the alignment wheel 16, to feed the blister strip 6 through the device. As the alignment wheel 23 rotates, the used blisters 6d are fed out of the cavity 22 down the used blister feed path 30, and through the slot 14 out of the housing 2. A drive plate 27a is dependent on a longitudinal edge of the lever arm 7, and carries a driving pawl 28 thereon, for cooperation with the detent teeth 25 on the alignment wheel 23, during rotation of the actuator 3 from the open position to the closed position. The drive ratchet 28 is integrally formed in the drive plate 27a by cutting a U-shaped groove therein to form an elastically deformable tongue 29 from which the ratchet 28 stands. The mouth piece 5 is integrally formed with the lever arm 7 of the actuator 3, and stands from one side thereof, opposite the side from which the piercing heads extend 9. The interior of the mouthpiece 5 can be observed from the cross-sectional view of Figure 9, and is divided into a primary chamber and a secondary chamber 31, 32, by a dividing wall 33. An external air intake orifice 34 in the side wall of the mouthpiece 5, next to where it it joins or becomes the lever arm 7, it is in communication with the primary chamber 31. The primary chamber 31 is also in communication with one of the openings lia on the lever arm 7, which are formed in the vicinity of a perforation 9. The secondary chamber 32 constitutes the main internal volume of the mouth piece 5, and is in communication with the other opening llb in the lever arm 7. A deflection opening 35 extends through the partition wall 33. , to comunicate the primary chamber 31 with the secondary chamber 32, for reasons that will become apparent. The path of the blister strip 6 through the device, and the manner in which it is placed inside the chamber 20, can be more clearly seen in Figure 7. It will be appreciated that the rolls of the blister strip 6 are loosely wound in the chamber 20, so that the blister strip 6 will unwind in response to a pull force applied to the leading edge 6e of the strip, by the aligning wheel 23 sonforme the alignment wheel 23 rotates. To prevent the rotation of the alignment wheel 23, otherwise due to the rotation of the actuating member 3, the housing 2 is provided with an elastically flexible arm, integrally formed, which carries an anti-rotation ratchet 37, which normally it is located in one of the recesses of the alignment wheel 23, which is not occupied by a blister 6a, as shown in Figure 6. The coupling of the ratchet 37 with the alignment wheel 23, prevents the alignment wheel 23 turn A release pin 38 is raised from the drive plate 27a which engages the arm 37, to urge the pawl 38 out of the recess, to allow rotation of the alignment wheel 23, when the actuator 3 approaches its fully open position. When the pawl 38 is deviated from the recess 24, the strip 6 of blister packs could be pulled from the housing 2. To prevent this, a second anti-rotation pawl 39, elastically deformable, is provided on the housing 2. The second ratchet 39 anti-rotation has a cam surface 40 on it, which is engaged by a cam member 41 on the actuator 3, when the first anti-rotation ratchet 37 is pushed out of the recess 24 of the alignment wheel 23. The second ratchet 39 anti-rotation is therefore secured in position and project into another recess 17 of the alignment wheel 23. This prevents the alignment wheel 23 from rotating by more than about 45 degrees, and thus the strip can only be pulled through the device by about half a blister width. It will be appreciated from the foregoing that the inhalation device according to this embodiment of the invention has a very simple construction with relatively few components. If the lid 4 is integrally formed with the housing 2 in a simple molding and the actuator 3 is formed together with the mouthpiece 5, the piercing heads 9, the plate drive 27a and a driving ratchet 28 in another molding, the device can be formed from as few as 4, 5 or 6 molded plastic parts. The operation of inhaler 1 will now be described. When the inhaler 1 is not in use, the cover 4 and the lever arm 7 are both in a closed position in which the cover 4 covers the mouthpiece 5, and the lever arm 7 lies generally against the side of the housing 2 with the drilling heads 9 extending through the opening 8 in the housing 2, and into a previously depleted blister 6d, which lies immediately below the opening 8 and constrained in the upper recess 24 of the wheel alignment 23, adjacent to the opening 8. The first and second anti-rotation pawls 37, 39 prevent rotation of the alignment wheel 23 in any direction, and thus place the blister in position. When the lid 4 is opened, the lever arm 7 can be pivoted towards the position shown in Figure 3. As the lever arm 7 pivots, the driving pawl 28 on the drive plate 27a raises the ramp section 26 forming one of the detent teeth on the end of the alignment wheel 23, and thus no rotation of the alignment wheel 23 occurs. Once a fully open position has been reached, as shown in Figure 3, the drive ratchet 28 has reached the end of the ramp section 26, and falls against the face of a corresponding shoulder 27, so that as the actuator 3 is rotated again in the opposite direction from the open position to the closed position, the coupling between the driving pawl 28 and the shoulder 27 causes the alignment wheel 23 to rotate. It will be appreciated that if the lever arm 7 is not opened to its fullest degree before being returned to its closed position, the alignment wheel 23 will not rotate, because the drive ratchet 28 will not be lowered to engage a shoulder 27 at the top of the ramp section 26. Just before the lever arm 7 reaches its fully open position, the release pin 38 on the drive plate 27a engages the arm 36 from which the first arm extends. anti-rotation ratchet 37, and deflects it so that the anti-ratchet ratchet 37 moves out of the recess 24 in the alignment wheel 23, so that the alignment wheel 23 can rotate and the strip 6 can be aligned when the alignment arm Lever 7 is rotated in the opposite direction. At the same time, the cam member 41 engages with the cam surface 40 of the second anti-rotation ratchet 39, and secures it in position to ensure that the strip 6 can not being pulled from the inhaler 1 by more than about half the width of a blister 6b. As the lever arm 7 is pivoted back to its closed position, the alignment wheel 23 is rotated through 90 degrees, as a result of the coupling between the drive ratchet 28 and the shoulder 27 on the alignment wheel 23. While the Lever arm 7 is rotated back to its closed position, the anti-rotation pawls 37, 39 have returned to their original positions securing the alignment wheel 23 in place. This rotation of the alignment wheel 23 carries the next blister 6b in position immediately below the opening 8 in the housing 2. In the final stage of the return stroke of the lever arm 7 back to its closed position, the heads of perforation 9 pass through the opening 8 in the housing 2 and penetrate the lid 6c of the blister 6a that has just been moved into position by the alignment wheel 23. The dose is now ready for inhalation, as will now be described. When a user inhales through the mouth piece 5, a low pressure region is created in the secondary chamber 32, which causes the air to be extracted through the blister 6a from the external air inlet 34, via the primary chamber 31 and the flow opening of air in the lever arm 7, as indicated by the arrows marked "X" in Figure 9. This flow of air through the blister 6b drags the dose contained therein, which is taken to the secondary chamber 32 and from there to the patient's airway. The turbulent air flow generated through the opening 11b in the lever arm 7 around the piercing element 9, helps to deagglomerate the dose and create a respirable aerosol. The air diversion orifice 35 in the partition wall 33 between the primary and secondary chambers 31, 32 reduces the total pressure drop across the device, and thus makes it easier for the patient to inhale. This also increases the turbulence in the secondary chamber 32. ' In a particularly preferred arrangement, the diverting orifice 35 is located such that the air flow through it, indicated by the "Y" arrow in Figure 9, meets the air flow entering the secondary chamber. 32 from the blister to a tangent or straight angle, to create a cyclonic effect, or increase the turbulence of the air flow to help deagglomeration. Once the device has been used a number of times, the side cover 13 can be opened and the visible section 6d of the used blister packs can be detached from those who remain inside the device, as already explained. A second embodiment of the inhaler according to the invention will now be described with particular reference to Figures 11 and 12. In this embodiment, the actuator is coupled to the layer covering the mouthpiece, so that a blister is punctured when the cap it is open and aligned to move the next unused blister in position below the opening in the housing, when the lid closes. This provides a device that is very simple to operate, since the user does not have to open the lid before pivoting the actuator to align and puncture a blister. With reference to the exploded view of Figure 11, the inhaler 1 is similar to the device described with reference to the first embodiment, except that the detent teeth on the alignment wheel 23 have been replaced with a toothed gear wheel 40 which it is coupled to the alignment wheel via a one-way or clutch mechanism (not shown) so that the alignment wheel 23 will rotate together with the gear wheel 40 only in one direction of rotation, the gear wheel is free of turning in the opposite direction in relation to the alignment wheel 23.

The actuator has a construction similar to the actuator 3 of the first embodiment and comprises a lever arm 7 with the mouthpiece 5, and the piercing heads 9 that rise from the opposite sides thereof. However, in this embodiment, the user directly does not pivot the actuator 3. Rather, a cam pin 41 protrudes from the side of the lever arm 7 adjacent to the remote end, opposite the pivotally mounted end to the housing 2. The cam pin 41 is located in a sliding guide or cam groove 42, formed on the inner surface of a cover 43, pivotally coupled to the side of the housing 2, at the same end, but spaced from the site in which the actuator 3 is pivotably coupled to the housing 2. The cover 43 also carries a toothed gear wheel 44 coupled thereto, for rotation together with the cover 43, which is placed in meshed engagement with the gear wheel 40 on the alignment wheel 23. As already mentioned. mentioned with reference to the first embodiment, the inhalation device according to the second embodiment also has a very simple first construction with relatively few components. For example, if the toothed gear wheel 44 is integrally formed together with the cover and the actuator 3 is formed together with the mouthpiece 5 and the 9 drilling heads, the entire device can be formed from as few as 4, 5 or 6 molded plastic parts. Due to the small number of parts that the simplicity of the device, there is more storage space within the device for the blister, thereby reducing the frequency in which it must be filled or replaced. It is intended that the devices of the present invention have a capacity to maintain between 1 and more than 100 doses, although it will preferably be able to maintain between 1 and 60 doses, and most preferably between 30 and 60 doses. The charge of each blister can be between 1 μg and 100 mg. However, preferably, the filler is in the region of 1 mg to 50 mg, and most preferably 10 mg and 20 mg. It will also be apparent that due to its simplicity, the device can be disposable once all the blisters contained therein have been used. In this case, the housing can be formed as a permanently sealed housing, to prevent tampering. The operation of the inhaler according to the second embodiment will now be described with particular reference to Figures 12A and 12B. As can be seen in Figure 12A, when the lid 43 is closed, the drill heads 9 on the actuator 3 are maintained cleared from opening 8 in housing 2, by means of the cam pin 41 located on the cam slide 42 on the lid 43. The cam slide guide 42 is preferably shaped so that the lid 43 can be initially pivoted relative to the housing 2 by the minus 90 degrees, without any movement of the actuator 3 occurring, thereby allowing the inspection or cleaning of the mouthpiece 5 without drilling a blister 6a. However, when the cover 43 is rotated relative to the housing 2 beyond 90 degrees, the cam pin 41 is guided by the slide guide 42, causing the actuator 3 to pivot to a position shown in the Figure 12B, in which the piercing elements 9 extend through the opening 8 in the housing 2, and penetrate a blister 6b located immediately behind the opening 8 within the housing 2. In this stage, the dose can be inhaled through the mouth piece 5. As the lid 43 opens, the gear wheel 40 rotates due to engagement with the gear wheel 44 on the lid 43. However, due to the one-way clutch mechanism, the wheel of alignment 23 does not rotate as cover 43 is opened, and gear wheel 40 is rotated in this first direction. However, once the lid 43 is rotated in the opposite direction, for example from the open position towards the closed position after inhalation, the drive of the gear wheel 40 is transferred to the alignment wheel 23, so that it rotates and moves the next blister 6a in alignment with the opening 8. It will be appreciated that during the initial movement of the lid 43 from its position towards its closed position, the actuator 3 will be first pivoted, due to the engagement of the cam pin 41 on the cam guide 42, so that the perforating elements 9 are raised from the opening 8 and return to the position shown in Figure 12A. It is considered that, in any modality, an opening or window could be provided in the housing 2, and a number of doses printed on each blister 6a, readable through the opening or window, so that the user can monitor the number of doses that have been used, or that remain in the device. This avoids the need for a complicated, dose counting mechanism, often found in conventional devices. Alternatively, the housing 2 could be completely or partially formed from a transparent material, so that the number of blisters 6 remaining in the device can be clearly seen through the walls of the housing 2.

As shown in Figure 13, the blister strip 6 is provided by use with the inhaler 1 of the invention may be provided with serrations, cut lines 50 or other frangible features to facilitate the separation of the blisters 6a from one another. Alternatively, or in addition to the frangible features, the edge of the blister strip 6 may be provided with recesses 51 between each blister 6a to make the strip easier to break. Yet another embodiment of the device will now be described with reference to Figure 14A to 19. This version of the device has apparent benefit of being small in size with respect to the number of blisters it may contain. Instead of placing the alignment wheel in its own cavity adjacent to the opening of the housing through which the piercing heads extend, the alignment wheel is integrally formed in the hinge, the pivoting lever is pivotally connected to the housing . This frees up more space within the housing for blister storage. As can be seen from the drawings, the device is capable of containing a reel of at least 60 blisters. Referring now to Figures 14A and 14B, two perspective views of the inhaler are shown in accordance to this modality. The inhaler 50 is similar to the inhaler 1 of the first embodiment and comprises a housing 51 having an actuator 52 in the form of a lever arm 53 pivotably mounted to the housing 51 at one end. A piercing member comprises a pair of piercing heads 54 that extend from the lever arm 53 and collapse in an opening 55 in the housing, where the actuator 52 is in a closed position, with the lever arm 53 being tends substantially against the housing 51, as shown in Figure 14A. A cap 56 is pivotably coupled to the housing 51, and is operable to cover the mouthpiece 57 when the inhaler is not in use. As with the first and second embodiments, the mouth piece 57 is integral with the lever arm 53 although it has a triangular or semicircular section against which they can be placed on the edges, as opposed to a tubular section that is placed in the mouth . The shape of the mouthpiece and the construction of the airway within it, is illustrated in the cross-sectional view of Figure 18. It will be appreciated that the construction of the airway is very similar to the construction of the track of air described with reference to the first and second modes, and thus no further description will be made here. However, it It will be appreciated that because the alignment wheel is now positioned away from the region where the blister is perforated, the blister to be perforated is now supported on a blister support block 58 (see Figure 17). The device 50 includes an alignment wheel (not shown) that incorporates a seal mesanism as has already been described with reference to the first and second embodiments, except that in this embodiment the alignment wheel has been made integral with the hinge around which the lever arm 53 pivots , so that it rotates about the same axis as the lever arm 53. When the lid 56 has been opened and the lever is pivoted from its closed position (as shown in Figure 14A) to its open position (as shown). in Figure 14B), the alignment wheel rotates together with the lever due to the engagement between a detent mechanism between the alignment wheel and the lever 53, and thus pulls a blister in alignment with the opening 55, and places in the block 58 of blister support. However, when the lever is returned to its closed position, the alignment wheel does not rotate due to the detent mechanism, so that the blister strip remains stationary. A second detent connection between the alignment wheel and the housing prevents backward rotation of the alignment wheel. During the final part of the race return, the piercing elements 54 extend through the opening 55 and pierce the cap of the aligned blister. The dose is now ready for inhalation through the mouth piece 57. As described with reference to the previous modalities, the device may incorporate a camera to receive used blister packs. However, this is not essential and the used blisters can simply be simply fed out of the device. A cutting edge 59 (see Figure 16) may extend from the opening against which the used blisters may be torn by pulling them against the edge in the direction indicated by the arrows in the drawing. The cutting edge can be sawed to facilitate detachment. It will be noted that the strip is prevented from being pulled out of the device by the drilling heads, which are located in a blister, and secures it in position. It will be appreciated that any configuration of the piercing member can be utilized including solid or hollow pins as well as piercing blades. However, it is desirable to include features that increase the flow of air to the blister to aid entrainment and deagglomeration by, for example, introducing a vortex air flow into the blister. A particular arrangement of Drill head 60 which can be used with any embodiment of the invention, and which allows a freer flow of air to the blister, will now be described with reference to Figures 18 and 19. As can be seen from Figure 18 , the piercing member 60 is preferably integral with the lever arm having a pair of openings 61 therein, for air flow to the blister, and the air flow together with the dose out of the blister. The piercing member 60 comprises a pair of piercing heads, each of which comprises a pair of secondary cutting elements 62 spaced apart from one another, and extending in a lateral direction from a primary, pointed cutting element 63. , which is mounted on and extends between the secondary cutting elements 62. The primary and secondary cutting elements 62, 63 extend over one of the openings 61 in the degree of lever 53. Each of the secondary cutting elements 62 divided into first and second cutting members 62a, 62b extending laterally from opposite sides of the primary cutting element 63. The first and second cutting members 62a, 62b are angled upwardly away from the lever arm, and the element of primary cut is raised from the secondary cutting member 62 in the point where the first and second cutting members 62a, 62b of each secondary cutting element 62 meet. The secondary cutting elements 62 are inclined inward toward each other, so that the central drilling member 63 is diamond-shaped in the side profile. As shown in Figure 19B, this open construction allows more air to flow around the sides of the blister compared to the arrangement of the piercing member of Figure 8A, since the side teeth restrict air flow to the blister ( as shown in Figure 19A). It will be appreciated that the dimensions of the perforator of the present invention can be chosen to suit the different sizes and shapes of the blister packs. In addition, the number and arrangement of the perforations can be varied within the scope of the invention. For example, a large blister can have a pair of larger perforators, or multiple pairs of smaller perforators, for example two perforators for the air inlet and two for the air outlet. It will further be appreciated that the use of the perforator of this invention is not limited to the inhalers described in the inhalers described in the embodiments, and can be used with any inhaler comprising a pierceable blister.

With reference to Figures 20 to 26, another embodiment of the invention will now be described in detail. The inhaler 70, according to this embodiment, comprises a housing 71 having an actuator 72 pivotably mounted thereto for rotation relative to the housing 71 about an axis indicated by the line marked "A" in Figures 20 to 22. A cover 73 is pivotably coupled to the housing 71 and can be moved between an open position, as shown in Figure 20, and a closed position in which the cover 73 covers a mouthpiece 74 to protect it, and to prevent entry. of powder towards the housing 71 through the mouthpiece 74. In Figure 21, the actuator 72 has been pivoted about the axis "A" from its closed position shown in Figure 20 to its fully open position to reveal a member of piercing, comprising a pair of piercing heads 75, which are raised from the actuator 72 and an opening 76 in the housing 71 through which the piercing heads 75 extend when the 72 is in its closed position. A finger grip 77 is integrally molded on the front edge of the actuator 72 for facilitating the movement of the grinder 72 by the user, between its open and closed positions. As with the previous embodiments, the housing 71 contains a rolled strip of blister packs 78 (see Figure 23) and one such blister 78a (see Figure 21) is located in a piercing position in which it is visible through the opening 76 It will be noted that each of the blisters in the strip 78 are numbered and the number of blisters located in a perforation position is also visible through the aperture 76. An edge of the aperture 76 is provided with a cutout 79 (see Figure 21) to enable the number of this blister 78a to be observed by the user, when the actuator 72 is in its open position * As already described with reference to the embodiment of Figure 4, a cover 80 is pivotably coupled to the housing 71, and encloses a space to receive the used blister packs 78b which are fed in this space through a slot 81 (see Figure 23) formed in the wall of the housing 71. It can be seen that the space enclosed by the cover 80 is large enough to accommodate only a few used blisters 78b, at a time, and thus a section of the blisters 78b must be periodically removed from these unused blisters 78, which remain in the housing 71. In this embodiment, as shown in Figure 22, the cover 80 is pivotably hinged to the housing 71 for rotation about an axis that is substantially parallel to the direction of movement of the used blisters 78b outside the housing 71. Even when the cover 80 is closed, there is an empty space (not shown) between the cover 80 and the housing 71- so that, if a user does not remove a strip of the used blister 78b, when the space is full, the used blister 78b will pass through this empty space and be projected outside the housing 71. As can be seen from Figures 23 and 25, the housing 71 is preferably formed in two halves which, as with all modes, can be formed from a translucent plastic such as polypropylene, and which are held together using appropriately placed and integrally molded mounting spikes (not shown) cooperating with the corresponding mounting posts 83. In the side view of the device shown in Figure 23, one half of the housing 71 has been removed , so that the location and trajectory of a rolled strip of blister 78 through the housing 71 is clearly visible, as are the intern components. us device. The cover 73 of the mouthpiece and the cover 80 have been omitted from Figure 23 for purposes of clarity. Although the two case halves can be detachable by the user to enable them to fill the housing with a new strip of blister packs, it is also considered that the inhaler could be of the "single use" type in which a strip of blister packs is placed in the housing during assembly, which is subsequently subsequently sealed. Once the blister strip has been exhausted, the entire device is simply discarded. It will be appreciated that the simplicity of the preferred embodiments of the device and the fact that these are made from a relatively small number of components (no more than nine), all of which are made of a plastic material, means that this is much cheaper to manufacture and so make it disposable after a simple strip of blister has been exhausted, which is a viable proposition. The seal of the housing during manufacture also makes the device tamper-proof. The blister strip 78 passes over a blister strip attaching frame 84, received in the housing 71 and mounted adjacent to the opening 76. As can be seen more clearly from the exploded view of Figure 25, the chassis 84 comprises two wall members parallel 84a, 84b arcuately shaped, attached to and spaced from one another by a width that is only slightly greater than the width of the blister strip 78, so that the strip 78 (only a short section of which is shown in FIG. Figure 25) passes between the walls members 84a, 84b and is guided and supported by them and by the upper wall of the housing 71, as the strip 78 passes through them. Each wall member 84a, 84b is provided with integrally molded legs 85, which are placed between the corresponding legs 86 integrally molded into the housing 71. Similarly, each wall member 84a, 84b has grooves 87 that engage with the corresponding positioning features 82 on the housing 71, to securely mount the stripping frame chassis 84 in position. Chassis 84 strip striker, includes an arm 88 elastically deformable projecting from between the wall members 84a, 84b. The arm 88 is preferably integrally molded with the strapping chassis 84, from a plastic material such as acetal. The free end of the arm 88 is divided into two orifices 89, between which an alignment wheel 90 is rotatably mounted. Referring now to Figure 26, the alignment wheel 90 has four spokes 91 accommodated in a form of "X", and is positioned substantially coaxially with the axis "A" around which the actuator 72 rotates with respect to the housing 71. The housing 71 is also provided with anti-rotation of the alignment wheel and positioning ramps 92., 93, with which the alignment wheel 90 interacts, to selectively prevent and allow rotation of the alignment wheel 90, as will be explained later in detail. The actuator 72 includes a pair of flanges 94a, 94b. A flange 94a has a shaped opening 95 which is placed directly on a correspondingly shaped pin 96, integrally formed on the housing half 71. The other flange 94b is provided with a larger opening 97, which is shaped to receive a coupling plate. 98 in this one. The flange 94b is provided with a recess 99 in an edge of the opening 97 in which a positioning tab 100 is received, which protrudes from the coupling plate 98. The coupling plate 98 has a shaped opening 98a, which is placed on a correspondingly shaped pin 101, on the other half of the housing 71. An arcuate-shaped opening 105 in the housing 71 surrounds the pin 101 through which extends an angularly shaped drive tooth 102, projecting in an inward direction since the coupling plate 98. The driving tooth 102 extends within a space between two spokes 91 of the alignment wheel 90, and its function will now be described with reference to Figure 26. Figure 26 illustrates a series of drawings for show how the alignment mechanism works when the actuator 72 is rotated between its closed and open position, and again to its closed position once more. The blister strip 78 has been omitted from Figure 26 for clarity, although it will be apparent that, as the alignment wheel 90 rotates, a blister will be placed between a pair of beams 91, and pulled through the housing 71. With reference to Figure 26A, the actuator 71 is in its closed position, and the arm 88, with the alignment wheel mounted thereto, lies in an unstressed or relaxed state in which external forces are not applied to it. The driving tooth 102 can be. observed placed between two of the spokes 91a, 91b and the beam 91d is placed between the anti-rotation and positioning ramps 92, 93. The anti-rotation ramp 92 prevents any rotation of the alignment wheel 90, in a clockwise direction, as seen in the drawing. When the actuator 71 is rotated to its open position, in the direction of the arrow "A" in the Figure 26B, the driving tooth 102 contacts the spoke 91b. Further rotation of the actuator 71, as shown in Figure 26C, causes the alignment wheel 90 to rotate, in a counter-clockwise direction, as seen in the drawing, due to the coupling between the drive tooth 102 and the beam 91b, whereby the blister strip 78 is aligned. As the alignment wheel 90 rotates, the beam 91c comes into contact with the anti-rotation ramp 92. When the anti-rotation ramp 92 and the beam 91c are coupled, further rotation of the actuator 71 in the direction of the arrow marked "A" causes the arm 88 to deform elastically and deviate in an upward direction (in the direction of the arrow marked "B" in Figure 26C ) so that the beam 91c can clear the anti-rotation ramp 92. When the actuator 71 has been rotated to its fully open position, the alignment wheel 90 has rotated through a total of 90 degrees and the beam 91c clears the anti-rotation ramp 92, thereby allowing the alignment wheel 90 falls down again and arm 88 returns to its original state not deformed. The actuator 71 is now rotated back to its closed position, in the direction of arrow "C" in Figure 26E. The drive tooth 102 is shaped so that, after the return stroke of the actuator 71, it slides over the upper part of the preceding ray 91a, and does not rotate the alignment wheel 90 in a clockwise direction. As shown in Figure 26C, engagement of the drive tooth 102 with the alignment wheel 90 effectively causes the arm 88 and the alignment wheel 90 to deviate in a downward direction in the direction of the arrow marked "D" in Figure 26E. In this position, the beam 91c is pushed down between the anti-rotation and positioning ramps 92, 93, whereby any rotation of the alignment wheel 90 in any direction is prevented. After completion of the return stroke, the piercing heads 75 pierce a previously unused blister, which has been newly aligned in its place and is visible through the opening 76 in the housing 71. It will be appreciated that, if the actuator 71 is returned to its closed position before the full stroke is completed, the tooth 102 will engage the spoke 91a and will cause the alignment wheel 90 to rotate in a counter-clockwise direction back to its original position . This ensures that a partial index can not take place and thus the drill heads 75 will always enter a blister.

Although the piercing heads 75 can be integrally formed together with the actuator 71, it is also considered that the piercing member can be formed as a separately molded component 105, as shown in Figures 27, 27A and 27B, which is placed in a recess 103 with walls in the actuator 72, as shown in Figure 28. The piercing heads then extend from this separately molded component. This will now be described in more detail. The piercing member 105 may be used with any of the embodiments of the inhalation device described herein and, as shown in Figure 27, 27A and 27B, comprises a main body portion 106 having an upper surface 107 that is it tends to level against the top surface of a lid of a perforated blister 119, when the perforator has completely entered the blister 119. The piercing head comprises a piercing tooth 108 that rises from the upper surface 107, and another piercing tooth 109 which rises from a relieved or recessed region 107a 'of the upper surface 107. The geometry of the teeth 108, 109 is similar to the geometry of the teeth already described with reference to Figures 18 and 19. The openings 110, 111 are formed on the surface upper 107 and recessed region 107a below teeth 108, 109, respectively. As can be seen in Figures 27A and 27B, the angles of the perforator are chosen to facilitate effective and clean cutting of the blade without tearing the blade in a controlled manner. The preferred ranges and values for these angles are given in the following table: It may be advantageous to form the primary cutting element 63, so that it is positioned asymmetrically with respect to the secondary cutting elements 62. The first and second cutting members 62a, 62b of each secondary cutting element 62 each extend laterally from the primary drilling element for different distances, such that the two flaps formed by a drill head are not the same size, as can be seen in Figure 27A. As seen in the drawing, the drill heads 108, 109 are arranged so that the smaller flaps are formed towards the ends of the major axis of the blister, where the depth of the blister is shallower, and the larger flaps are formed towards the center of the blister, where the blister is deeper. The relative length of the first and second cutting members 62a, 62b is defined by the ratio k: j in Figure 27A. Preferably, this ratio is between 1 and 2. In the embodiment of Figures 27, 27A and 27B, the ratio is 1.2. By making the flap unequal in size, it is less likely that drug agglomerates will get caught in the blister. A short tubular section 112 depends on the other side of the main body portion 106, in the opposite direction to the tooth 108, and is in communication with the opening 110. The outer surface of the tubular section 112 has spacer rims 113, which extend axially, for reasons that will become apparent. A mounting pin 114 also depends on the main body portion 106, to facilitate coupling the piercing member 105 to the actuator 72. When a user inhales through the mouthpiece 74, the air is sucked through the opening 111. and towards the blister 119, via an opening in the lid 119a of the blister 119, created by the tooth 109. The tooth 109 it rises from a recessed region of the main body portion 106, so that a clearance is created between the cover 119a of the blister and the surface of the recessed region 107a, to allow free and unrestricted flow of air to the blister 119, through the opening 109. The drug 119c contained in the blister 119 is entrained in the air flow entering the blister 119, formed by the tooth 109, and is carried out of the blister 119 through the opening cut by the tooth 108, through the opening 110, and the tubular section 112 inside the mouthpiece 74, from where it passes towards the teeth. patient's airway. The upper surface 107, around the tooth 108, is shaped to fit tightly against the blister lid, when the teeth 108, 109 have entered the blister 119, to its fullest extent, so that the leakage of air into the flow of output air between the upper surface 107 and the lid of the blister 119a is reduced to a minimum. As already described with reference to Figure 9, to reduce the total pressure drop across the device and make it easier for the patient to inhale a dose, the outside air is introduced into the outlet air flow through a duct of deflection 118. In this embodiment, the drill head 105 is mounted to the actuator 72 via the tubular section 112, which is placed inside the hole 103 with walls. The flanges 113 form an interference fit with the gap 103 with walls, but the bones or voids between the ridges 113 form a diversion conduit 118 through which the deflection air is pulled towards the mouthpiece 74, along with the flow of air passing through the blister 119. It will be appreciated that the diverting air does not pass through the blister 119, but enters the buccal part 74 separately. This reduces the total resistance to the inspiratory flow, making the device easier to use. As has been described with reference to the embodiment of Figure 9, mixing the diversion air with air that has passed through the blister 119 also makes possible the more efficient dispersion of the drug in the inspired air. A mesh 115 (see Figure 29) can also be molded into the mouthpiece 74, through which all the inspired air passes to provide additional dispersion. The holes 114 are provided in a region where the mouthpiece 74 is attached to the actuator 74 through which air is fed via the opening 111 into the blister 119 and, via the bypass conduit 118, formed by the spaces between the flanges. 113 in the mouthpiece 74.

The flow of air through a perforated blister 119 and into the mouthpiece 74 is illustrated schematically in Figure 29. When a patient inhales through the mouthpiece 74, the air is pulled from the outside through the holes 114. between the mouthpiece 74 and the actuator 72, from which it flows towards the blister 119 through the opening 111, as indicated by the arrow marked "F". In addition to the inflow of air through the opening 111, the air is also pulled towards the blister 119 through the space between the lid 119a of the blister 119 and the recessed surface 107a, as indicated by the arrow marked "G" . In addition to the air flow in the blister 119, the air is also pulled through the diversion conduit 118 (in the direction of the arrow marked "H") formed by the spaces between the flanges 113 of the tubular section 112 of the head of perforation 105, and joins the flow of exhaust air leaving the blister 119 through the opening 110 in the piercing member 105, in the direction of the arrow marked "I". The dose is drawn into the outflow of air and this air flow from the blister 119 together with the air that has flowed to the mouthpiece 74 via the bypass conduit 118, passes through the mesh 115 and out of the device to the tracks of the patient, in the direction of the arrows marked "J". This modality as described has nine molded components. While this is significantly less than other devices with a similar number of doses, it is possible to reduce the component count further. The case halves can, for example, be molded as a simple molding connected by an integrally molded hinge, at the base of the components. In the assembly the two halves could be folded together to form the housing. Similarly, the lid and the blister door can be integrally molded. Furthermore, it has been described that the piercing element can be molded as part of the actuator. In this way, the number of molded components can be reduced to five or six. A final embodiment of an inhaler according to the invention will now be described with reference to Figure 30. It will be appreciated that it is advantageous that the used blisters are ejected from the device since this results in a smaller and simpler construction. If the device is to retain used blister packs, then a take-up reel is required over which is rolled the used blister strip. The obvious disadvantage of a pickup sarrete is that at all times during the use of the device there is an empty space inside it. When the device is first used, the pickup reel is empty, and at the end of its life, the feed reel is empty. Consequently, the device must be made larger to accommodate the blister strip before and after use. In an alternative embodiment of the present invention, the inhalation device preserves the blisters used in a more compassionate arrangement with which there is no unused space. This is achieved by forming the blister strip in an endless loop, and assembling the loop in the housing in a state in which it has been wrapped around itself, as shown in Figure 30. With reference to the Figure 30, it can be seen that the housing 120 contains two parallel spaced walls 121, 122 to define a pair of parallel spiral channels 123, 124 between them. The inner end of the channels 123, 124 open towards a central chamber region 125 in which a feed spool 126 and a feed pin 127 are rotatably mounted. The blister strip 130 passes from one channel 123 to the other channel 124 through the region of chamber 125, and extends around feed spool 126, and feed wheel 127 in an "S" shaped configuration. The blister strip 130 also passes out of a channel 124 and is wrapped around an alignment wheel (shown generally by the reference number 128) in Figure 30, before moving again to the other channel 123. The connections in both Ends in effect create a simple worm sanal for the blister strip 130. The blister strip 130 may be conveniently formed before its ends are subsequently joined together. If the length of the strip 130 is adjusted to the combined length of the two channels 123, 124, the strip 130 can be loaded into the channels 123, 124 and placed around the teeth (not shown) of the alignment wheel 128. and the internal sprocket 127, as well as being guided around the spool 126. The alignment wheel 128 aligns the strip 130 via the buccal piece / driver arrangement, as has been previously described with reference to Figures 20 to 26 , although other alignment mechanisms can also be used. If low friction materials are used, suitable the inner reel 126 and the sprocket 127 do not they need to be driven other than by strip 78 itself. For a long strip 78, or to ensure reliable operation, the reel 126 and the sprocket 127 can be connected to the alignment wheel 128 by a simple drive train, band or similar mechanism (not shown). Since the strip 130 is endless, with regularly spaced blisters, then the user will be able to align the strip 130 indefinitely. The inclusion of a blank section 129 in strip 130 that does not have blister packs, can provide a clear indication that all blisters have been used. This could be conveniently provided at the point where the ends of the strip 130 are joined together. When this blank section 129 of the strip reaches the alignment wheel 128, the strip 78 will no longer be aligned as the alignment wheel 128 rotates, clearly indicating that the strip 130 has been exhausted. In the drawing, strip 130 is shown with blank section 129, located just after alignment wheel 128. This is the position it will be in before the device has been used for the first time. Many modifications and variations of the invention that fall within the terms of the following claims will be apparent to those skilled in the art. the technique, and the above description should be considered as a description of the preferred embodiments of the invention only.

Having described the foregoing invention, the content of the following claims is claimed as property:

Claims (70)

REINVINDICATIONS

1. An inhaler comprising a housing for receiving a rolled strip of blister packs, each having a pierceable lid, and containing a dose of medicament for inhalation by a user, an actuator pivotably mounted to the housing, operable to cause the rolled strip of blister is unrolled to sequentially move each blister in alignment with a blister perforation member, the actuator is also operable to cause the blister perforation member to pierce the cap of an aligned blister, the actuator further comprises a buccal piece through the blister. which is inhaled by a user a dose of medicament, the inhaler is configured such that, when the user pivots the actuator or causes it to pivot, together with the mouthpiece, with respect to the housing and subsequently subsequently inhales through the piece buccal, a flow of air through the blister is generated, to drag the dose contained in This, and take it out of the blister and via the mouthpiece to the user's airway.

2. An inhaler according to claim 1, characterized in that the actuator is pivotably mounted to the housing.

3. An inhaler according to claim 1 or claim 2, characterized in that the actuator comprises an arm pivotably mounted to the housing at one end.

4. An inhaler according to claim 3, characterized in that the blister piercing member projects from one side of the arm positioned, to extend through an opening in the housing in a closed position, in which the arm lies substantially against the housing , for perforating the lid of a blister aligned with the blister perforation member.

5. An inhaler according to claim 3 or 4, characterized in that the piercing member comprises at least two discrete piercing heads, operable to pierce a corresponding member of holes in a blister aligned with the blister piercing means.

6. An inhaler according to claim 5, characterized in that each drill head comprises a primary cutting element and a pair of secondary cutting elements that extend laterally through each end of the primary cutting element.

7. An inhaler according to claim 6, characterized in that the primary cutting element and the secondary cutting elements each have a sharp point, the tip of the primary cutting element extends beyond the tips of each of the elements of secondary cut.

8. An inhaler according to any of claims 5 to 7, characterized in that an opening is formed in the arm in the vicinity of each drilling head, at least one of the openings forms an air flow inlet in a blister and, at less another of the openings forms an outlet of air flow from a blister.

9. An inhaler according to claim 8, characterized in that the mouth piece is on the arm and extends in a direction opposite to the direction in which the drill head extends, the openings in the arm are in communication with the internal part of the mouthpiece.

10. An inhaler according to claim 8 or claim 9, characterized in that the mouthpiece includes a primary chamber having an external air inlet in communication, via the primary chamber, with the or each airflow inlet opening in the arm and, a secondary chamber in communication with the or each airflow outlet opening in the arm, such that, when a user inhales through the mouthpiece, the air is pulled through the or each inlet opening. flow of air towards the blister, via the external air inlet and the primary chamber to draw the dose into the air flow, the dragged dose passing through or each of the airflow outlet openings towards the chamber secondary of the mouth piece from where it is taken to the user's airway.

11. An inhaler according to claim 10, characterized in that the dividing wall separates the primary and secondary chambers inside the mouth piece.

12. An inhaler according to claim 11, characterized in that at least one air deflection opening extends through the dividing wall to communicate the primary chamber with the secondary chamber.

13. An inhaler according to claim 12, characterized in that the or each deflection opening is configured such that the air flow coming from the primary chamber into the secondary chamber through the or each deflection opening, and the airflow coming from of the or each of the airflow outlet openings is substantially at right angles to one another.

14. An inhaler according to any preceding claim, characterized in that it comprises an alignment mechanism that includes an alignment member that moves a blister in alignment with the blister perforation member.

15. An inhaler according to claim 14, characterized in that the alignment member comprises an alignment wheel that rotates for move a blister in alignment with the blister piercing member.

16. An inhaler according to claim 15, characterized in that the alignment wheel is configured to rotate, to move a blister in alignment with the blister perforation member, in response to the rotation of the actuator in one direction, the movement of the actuator in the opposite direction is operable to pierce the lid of a blister aligned with the blister piercing member.

17. An inhaler according to claim 15, characterized in that the alignment wheel is configured to rotate, to move a blister in alignment with the blister perforation member, in response to the rotation of the actuator with respect to the housing in one direction, the movement of the actuator in the same direction is also operable to pierce a blister lid aligned with the blister perforation member.

18. An inhaler according to claim 16 or claim 17, characterized in that it includes a cover coupled to the housing, pivotable between a closed position in which it covers the mouthpiece, and an open position in which the mouth piece is revealed to make it possible for a user to inhale through the mouthpiece.

19. An inhaler according to claim 18, characterized in that the alignment wheel rotates to move a blister in alignment with the blister perforation member, in response to the rotation of the cap with respect to the housing from the open position to the closed position .

20. An inhaler according to claim 19, characterized in that the cap and the actuator include cooperating means for coupling the actuator to the cap, such that each actuator rotates relative to the housing in response to rotation of the cap between the open and closed positions. closed.

21. An inhaler according to the preceding claim, characterized in that the housing includes a chamber for receiving the used blister packs.

22. An inhaler according to claim 21, characterized in that the used blister chamber is covered by one. cover coupled to the housing, which can be opened to facilitate the removal of a portion of the blisters used from the blisters that remain in the device.

23. An inhaler according to claim 22, characterized in that it is a slot between the lid and the housing, when the lid is closed through which the used blisters can protrude when the used blister chamber is filled.

24. An inhaler according to any preceding claim, characterized in that it incorporates a rolled strip of blister packs, each having a pierceable lid, and containing a dose of medicament for inhalation by a user, located in the housing.

25. An inhaler according to claim 24, characterized in that the strip includes a frangible feature between each blister, to facilitate the detachment of a blister from an adjacent blister along said line.

26. An inhaler according to claim 24 or claim 25, characterized in that the strip includes a notch to facilitate tearing of the strip between each blister.

27. An inhaler according to any of claims 24 to 26, characterized in that the rolled strip carries between 30 and 60 blisters and each blister has a dose load of between 10 and 25 mg.

28. An inhaler according to any preceding claim, characterized in that it is formed from no more than five molded components.

29. An inhaler according to any of claims 1 to 28, characterized in that it is formed from no more than six molded components.

30. An inhaler according to any of claims 1 to 27, characterized in that it is formed from no more than nine molded components.

31. An inhaler according to any preceding claim, characterized in that the housing is completely or partially formed from a transparent or translucent material, allowing remaining blister packs to be observed through the housing.

32. A method for using an inhaler according to any of claims 1 to 31, characterized in that it includes the step of rotating the actuator to move a blister in alignment with the blister perforation member, and to pierce the lid of an aligned blister , inhaling through the mouthpiece to generate an air flow through the blister, to drag the dose contained in it, and take it via the mouthpiece to the user's airway.

33. A method according to claim 32, characterized in that the step of rotating the actuator includes the step of rotating it in a first direction, to move a blister in alignment with the blister perforation member, rotating it in a second direction to perforate the blister. Blister lid aligned with the blister punching member.

34. A method according to claim 33, characterized in that the step of rotation of the actuator includes the step of rotating it in a first step. direction for piercing the lid of a blister aligned with the blister piercing member and, once the inhalation step is completed, rotating it in a second direction to move a subsequent blister in alignment with the blister piercing member.

35. A method according to claim 34, characterized in that the step of rotating the actuator 'comprises the step of rotating a cover coupled to the actuator.

36. An inhaler, characterized in that it comprises a housing for receiving one or more blister packs having a pierceable lid and containing a dose of medicament for inhalation by a user, the device comprising a blister punching head for piercing the lid of a blister, so that the dose contained therein can be inhaled by the user from the blister, through the device, wherein the piercing head comprises a primary cutting element which is configured to cut, as the piercing member enters the blister, a first linear slot in the lid and, the secondary cutting elements extend laterally from the primary cutting element which are configured to cut, as the drill head continues entering the blister, the second linear grooves extending through each end of the first linear groove formed by the primary cutting element, the primary and secondary cutting elements together form a pair of flaps on the lid, which are folded to one side by the propagation head, after the additional entry of the punching head to the blister.

37. An inhaler according to claim 36, characterized in that the drill head comprises a pair of secondary cutting elements.

38. An inhaler according to claim 37, characterized in that the secondary cutting elements are spaced from one another and the primary cutting element is mounted on and extends between the pair of secondary cutting elements.

39. An inhaler according to any of claims 36 to 38, characterized in that the primary cutting element comprises a blade, the plane of the blade lies substantially at right angles to a plane occupied by the lid of a blister, which is located in the inhaler in a position ready for drilling.

40. An inhaler according to claim 5, characterized in that the primary cutting element has a sharp edge for cutting the first linear slit in the blister lid.

41. An inhaler according to claim 0, characterized in that the edge tapers towards a sharp pint.

42. An inhaler according to claim 41, characterized in that a secondary piercing element extends laterally through each end of the primary piercing element.

43. An inhaler according to claim 42, characterized in that the sharp tip 0 is halfway between the secondary cutting elements. '" 4 .

An inhaler according to any of claims 39 to 43, characterized in that the 5 secondary drill elements are each not formed of a blade, the plane of the blade lies substantially at right angles to the plane of the primary drilling element, and at right angles to the plane occupied by the blister cover.

45. An inhaler according to claim 44, characterized in that each of the secondary cutting elements have a sharp edge for cutting the second linear slots in the lid of a blister.

46. An inhaler according to claim 45, characterized in that the edge of each of the secondary cutting elements tapers toward a sharp point.

47. An inhaler according to claim 45, characterized in that the sharp tip of each of the secondary cutting elements lies in the plane of the blade, forming a primary piercing element.

48. An inhaler according to claim 46 or claim 47, characterized in that the sharp tip of each of the elements of Secondary drilling lies at the same height as the primary drilling element at the point at which the primary drilling element and the secondary drilling element meet with each other.

49. An inhaler according to any of claims 36 to 41, characterized in that the primary cutting element divides each secondary cutting element into first and second cutting members that extend laterally from opposite sides of the primary cutting element.

50. An inhaler according to claim 49, characterized in that the first and second cutting members converge towards each other at an angle and the primary cutting element rises from the top of the secondary cutting members from a point on each element. of secondary cut in which the first and second cutting members meet.

51. An inhaler according to claim 50, characterized in that the secondary cutting elements are angled inward towards each other.

52. An inhaler according to any of claims 36 to 51, characterized in that the secondary cutting elements extend laterally from the primary cutting element at an angle of 90 degrees to the primary cutting element.

53. An inhaler according to any of claims 36 to 51, characterized in that the secondary cutting elements extend laterally from the primary cutting element at an angle of less than 90 degrees.

54. An inhaler according to any of claims 36 to 51, characterized in that the secondary cutting elements extend laterally from the primary cutting element at an angle greater than 90 degrees.

55. An inhaler according to any of claims 49 to 54, characterized in that the primary cutting element divides each of the diseases into secondary cutting members that extend laterally from the primary cutting element for different distances, so that the flap cut in the blister by the secondary cut members that are extending laterally from one side of the primary cutting element, is of a size different from the flap cut in the blister by the secondary cutting members extending laterally from the other side of the primary cutting member.

56. An inhaler according to any of claims 36 to 55, characterized in that it comprises at least two drill heads that rise from a piercing member.

57. An inhaler according to any of claims 36 to 56, or according to any of claims 1 to 7, characterized in that the piercing member comprises a discrete piercing module.

58. An inhaler according to claim 57, characterized in that the piercing module comprises a main body portion with first and second piercing heads that rise from it.

59. An inhaler according to claim 58, characterized in that it comprises a air inlet opening and an air outlet opening extending through the main body portion, one of the drilling heads protrudes from the periphery of the air inlet and extends over the air inlet, and the another drill head protrudes from the periphery of the air outlet and extends over the air outlet.

60. An inhaler according to claim 59, characterized in that the main body portion includes a recessed region around the air inlet, the drill head protruding from the periphery of the air inlet from the recessed region.

61. An inhaler according to claim 59 or claim 60, characterized in that the air inlet opening is in communication with an air outlet tube that extends from the main body in a direction opposite to the drill head that is extends from the periphery of the air outlet opening.

62. An inhaler according to claim 61, characterized in that the outlet tube The air comprises axially extending ridges, formed on its outer surface, which place the piercing head inside a hollow with walls, in the mouthpiece.

63. An inhaler according to claim 62, characterized in that a space formed between the flanges and the hollow with walls, comprises a diversion air duct for the direct flow of air towards the mouthpiece from the external part, when a patient inhales through the mouth piece.

64. An inhaler according to any of claims 14 to 17, characterized in that the alignment mechanism comprises a blister strip laying frame defining a path for the blister strip beyond the opening of the housing.

65. An inhaler according to claim 64, characterized in that a deformable elastic arm extends from the blister strip attaching frame and the alignment mechanism comprises an alignment wheel rotatably mounted to the free end of the elastically deformable arm, on which it is passed. a strip of blister packs.

66. An inhaler according to claim 65, characterized in that the alignment wheel comprises a group of spokes, and the actuator includes a driving tooth engageable with the first beam, when the actuator is pivoted relative to the housing, towards a position open, to cause the alignment wheel to rotate together with the actuator, to align the blister strip.

67. An inhaler according to claim 66, characterized in that it comprises an anti-rotation ramp on the housing, which is coupled by another ray by the alignment wheel, when the alignment wheel rotates, thereby causing the arm to deform to allowing the beam to clear the anti-rotation ramp, the arm returns to its non-deformed state once the beam has cleared the ramp, thereby preventing rotation of the alignment wheel in the opposite direction.

68. An inhaler according to claim 67, characterized in that the driving tooth on the actuator is shaped so that, when the actuator is rotated in the opposite direction from its open position towards its closed position, the Drive tooth slides over the top of the preceding spoke of the alignment wheel.

69. An inhaler according to claim 68, characterized in that the edge of each ray is shaped to allow the driving tooth to pass over it, when the actuator is pivoted from its open position to its closed position.

70. An inhaler - according to claim 68 or claim 69, characterized in that it comprises a positioning ramp adjacent to but spaced from the anti-rotation ramp, the driving tooth is operable to cause the arm to deform elastically according to the driving tooth it slides over the top of the beam, to cause another beam to extend into the space between the anti-rotation and positioning ramps, and to prevent rotation of the alignment wheel in any direction.