HK1018012B - Inhaler for administering medicaments from blisterpacks - Google Patents

Description

Inhaler for administering a medicament from a sachet pack

Technical Field

The invention relates to an inhaler for administering medicaments from a sachet pack, wherein the sachet chamber is emptied by a squeeze-release aid.

Background

The function of an inhaler is to introduce fine solid drugs distributed in an air stream into the body of a patient, a so-called powder inhaler, which is currently used in large numbers in a variety of inhalation therapy embodiments. This inhaler replaces in part the previously customary aerosol inhalers, in which the aerosol is generated under conditions in which halogenated hydrocarbons are used as propellant gas, and is no longer desirable for environmental reasons. The powder inhalers used in the past have mostly used devices with a complicated technical design, from which the patient obtains the powder fraction (medicament) that can be inhaled by means of his inhalation.

One possibility for providing a predetermined dose of medicament is to enclose it in a suitable portion of a so-called "sachet", which is also used in other applications, for example, where enclosing a tablet would be helpful in achieving a more hygienic personal unsealing application.

EP- ｃA-0469814 describes an inhaler for administering ｃA powder medicament from ｃA blister pack in the form of ｃA strip, in which ｃA punch having ｃA flat surface is pressed against the blister to compress the powder or, as an alternative, ｃA knife edge with ｃA straight or curved punched surface is used to force the blister to tear open, but in the latter case in ｃA manner which does not ensure that the blister is reliably emptied of powder.

Patents EP-B-211595, GB-a-2,129,691 and GB-a-2,142,246 describe powder inhalers for administering a medicament from a sachet pack, wherein the medicament is encapsulated in a solid and finely divided form. A disc shaped sachet pack is inserted into a powder inhaler as described in patents EP-B-211,595 and GB-a-2,129,691, and in use the powder portion is released by a punch and after the powder has been completely emptied, the sachet disc is replaced with a new one. GB-a-2,142,246 relates to an inhaler for administering a powdered medicament from a blister pack comprising a container membrane and a wrapping lobe, wherein the container membrane has an array of independently distributed convexly curved blister cavities having a spherical curved surface shape for receiving the powdered medicament and the wrapping lobe encloses the blister cavities, the inhaler having an elongated housing with at least two housing parts which are connected to each other in an inverted manner by means of a joint or hinge, and wherein one of the housing parts has a recess as a support part for receiving a strip of the blister pack, and wherein one narrow end of the housing is provided with a mouthpiece, and the opposite narrow end is provided with an air inlet opening, and wherein between the two is provided an air duct adapted to receive the medicament from the blister cavity directly from the strip inserted into the support part, in such a manner that, the enclosing lobes of the inserted strip abut the airway and the housing has pins which expel the powder from the sachet and which are forced through the centre of the sachet cavity thereby compressing the powder.

An inhaler which is easy to handle and inexpensive is disclosed in the later published patent DE-A-4400084. The inhaler comprises a housing defining an elongate cavity sealed from the environment, the narrow end of the housing having a mouthpiece and the other end having an air inlet opening, the portion containing the capsule being disposed on at least one major surface of the housing. In one embodiment, the housing includes a splayed configuration in which one or more strip-like objects may be inserted, for example, pushed or inserted into a flip-open configuration. In all these inhaler embodiments, the user must press open the individual pockets of the cartridge individually with a finger, i.e. exert pressure on the curved dome thereof, causing the relatively thin wrapping flaps to tear open and allow the medicament to fall into the internal cavity of the housing. A disadvantage of this type of inhaler is that when the sachet chamber is pressed open by a finger, the powder therein is mechanically loaded and compressed, and therefore does not have any more fine dispersion or only insufficient dispersion in the inhalation air stream.

All these powder inhalers have the drawback of being very bulky, i.e. the volume ratio of the apparatus with respect to the dose of medicament used therein is rather large. Taking into account the volume and number of parts per instrument, it may be inconvenient for a patient to carry one such powder inhaler. Furthermore, due to their various and often complex working principles, these instruments run the risk of being mishandled or not being handled at all in case of an emergency (e.g. an acute asthma attack) or in case of a patient side not having any knowledge about the technique used.

The present invention is therefore based on the problem of proposing a handy and easy-to-handle powder inhaler for medicament capsules, in which the compression of the medicament in the capsule cavity is avoided by the process of squeeze-release of the medicament, so that the medicament is finely dispersed in the inhalation air stream.

The above object is achieved by an inhaler for administering a powdered medicament from a strip-shaped medicament capsule comprising a container membrane and a wrapping flap, wherein the container membrane has an array of independently distributed convexly curved medicament capsule cavities having a spherical crown-shaped curved surface for receiving the powdered medicament and the wrapping flap encloses the capsule cavities, the inhaler having an elongated housing with at least two housing parts which are connected to each other in an inverted manner by means of a joint or hinge and wherein one of the housing parts has a recess as a support part for receiving the medicament capsule strip, and wherein one narrow end of the housing is provided with a mouthpiece, and the opposite narrow end is provided with an air inlet opening, and wherein between the two is provided a gas duct adapted to receive the medicament from the medicament capsule cavities directly from the medicament capsule strip inserted into the support part, in such a manner that, in a press-release device for rupturing individual pockets, characterized by at least one punch having a punching surface with a concave curved shape corresponding to the convex curved shape of the pocket of the cartridge, the arrangement being such that, in a direction transverse to the longitudinal axis of the housing, the cutting edges of the concave curved punching surface of the at least one punch engage in an asymmetrical manner on the corresponding curved surface of the convexly curved pocket of the cartridge, so that the flap of the ruptured wrapping flap is caused to sag in a manner which does not obstruct the air flow inside the airway.

The following claims present preferred embodiments of the invention.

Disclosure of Invention

The inhaler according to the present invention functions to administer medicament from a sachet pack. Sachet packs are packages comprising a container film with a filled small recess or cavity and a wrapping leaflet which seals the recess. The term "sachet" within the scope of the present invention is to be understood broadly as a packaging of the type described above, irrespective of the container film and its method of manufacture. The receptacle portion of the container membrane has a wall thickness such that: the cavity can be squeezed from the outside inwards and this pressing action can cause the wrapping flaps to tear. In the following description, the above-described process of squeezing the cavity from the outside inward and the simultaneous process of tearing of the wrapping flaps and drug release is described as "squeeze-release".

Preferably, the housing of the inhaler according to the invention has the shape of an elongated body, one narrow end of which is provided with a mouthpiece and the opposite narrow end of which is provided with an air inlet opening. The sachet strip inserted into the housing has a row of sachet cavities arranged in sequence. According to design, the inhaler can always only accommodate a sachet strip having a specific number of pockets depending on the type and dose of medicament administered. An inhaler is designed for a variety of applications, using a sachet strip having four cavities.

The inhaler has a flip-open housing with at least two housing parts which are connected to each other in a flip-open manner by means of a hinge or a knuckle. For example, the housing may have a bottom section and an upper section connected to each other in a flip-over manner, or a middle section may be added. The bottom section or middle section shell is provided with a bearing seat which is used for containing the medicine sac strip and is provided with a groove. The upper housing section may also have inwardly directed webs which act to press the strip of sachets against the carrier seat thereby securing the strip of sachets in the closed inhaler.

The press-release device of the inhaler according to the invention has at least one punch, the concave punching surface of which is adapted to the shape of the capsule cavity. The capsule cavity of a conventional sachet has a curved shape which appears to be spherical crown shaped from the outside, and therefore the punch engaging surface is generally designed to be complementary to the spherical crown. The concave curved shape of the punch engaging surface matches the convex curved shape of the capsule cavity of the capsule so that the drug is not compressed within the capsule cavity when squeezed-released, thereby avoiding the problem of insufficient dispersion in the air stream.

The press-release device can be conveniently assembled in the housing. In order to tear open and empty the sachet cavity by means of the squeeze-release device, the user must press a part or the whole of the squeeze-release device with his finger or the whole palm. In this case, the force applied to the punch of the compression-release device, the surface of which engages in the outwardly curved capsule cavity, can be transmitted directly or via a lever. Where a lever arrangement is employed, the arrangement may be designed as a plurality of separate levers with respective squeeze-release punches or as a single lever with a single movably engaging squeeze-release punch.

In a preferred embodiment according to the invention, the press-release device is assembled in the upper housing and its action is not transmitted by means of a lever. The structural design of the squeeze-release device has a unique simplicity in that four squeeze-release punches are mounted in the upper housing by a gripper plate and, if desired, the user can empty the capsule cavity by depressing the punches one by one.

In another preferred embodiment according to the invention, the upper casing itself constitutes the squeeze-release means. The outstanding simplicity is that the upper housing is designed as a single lever with a movably engaging press-release punch. As a variation thereof, the upper housing may also be formed of a plurality of individual levers, each lever being depressed one by one during use.

The pressure of the die cut surface against the cavity causes the relatively thin wrapping lobes on the sachet pack to tear and the medicament either remains in the cavity due to adhesion or falls directly into the powder conduit of the housing.

During inhalation by sucking on the mouthpiece of the inhaler, the user creates a slight negative pressure inside the airway, which causes the drug still in the pocket to be transferred into the conduit and air to enter the conduit via the air inlet opening. Furthermore, the air flow in the conduit creates a local negative pressure (jet effect) as it flows through the ruptured capsule, and thus the drug will be well sucked out of the capsule without leaving a residue. Thereafter, the air flow out of the inhaler through the mouthpiece will carry the medicament with it for inhalation by the user, thereby allowing the medicament to flow into the lungs.

In order to exert the favorable conduction function of air in the air duct, the wrapping leaf of the medicine bag is torn or cut off in a determined manner. For this reason, the portion of the wrapping leaflet that originally seals the lumen will penetrate into the interior of the duct after breaking into some sort of debris attached only at one point, which is intended to be aligned parallel to the airflow. As an example, the use of a specially designed sachet will help achieve the above objectives. For example, a single capsule could be partially surrounded by an annular bead weld, such that during squeeze-release the wrapping leaflets would be severed in the area of the weld, while remaining attached to the remaining wrapping leaflets in the area of the weld discontinuity; alternatively, a predetermined tear point is provided on the wrap lobe. Furthermore, the asymmetrical design of the capsule-for example, with a chamfered shape on one side-also helps to define the tearing pattern of the wrapped leaflet.

In order to limit the tearing mode of the wrapping lobe when using a common capsule, the punch asymmetrically engages the capsule cavity during the extrusion-release process. As an example of a realization, the punch itself can be given an asymmetrical cross-sectional shape, i.e. the cutting edges of the curved punching surface run in a plane which is at an angle different from 90 ° to the longitudinal axis of the punch and intersect in a vertical plane running in the longitudinal direction of the housing, so that the punch, when pressed down, can first engage on one side of the outwardly curved capsule cavity. In this way, the wrapping flap can first be torn at the above-mentioned contact region while still being attached to the remaining wrapping flap on the side opposite the capsule. Furthermore, an asymmetrical design of the punch on the capsule cavity is also possible by an asymmetrically designed squeeze-release punch, which is laterally connected to the housing by a lever arm in such a way that, when the punch is depressed by the user, it will follow an arc path centered on the housing part pivot and the action of engaging the capsule cavity will take place first on one side. A squeeze-release punch having a longitudinally asymmetrical cross-section may also be used in combination with the lever arrangement. Of course, the above-described sachet packs having asymmetric sachets may also be used in inhalers where the squeeze-release device engages the sachet cavity in an asymmetric manner.

A preferred embodiment of the inhaler according to the invention has a mouthpiece, the inner chamber of which is provided with a cyclone chamber containing tangential inlet slots into which secondary air can enter via a suitable conduit. After the rupture of the sachet cavity and as the user sucks on the mouthpiece, the medicament will enter the mouthpiece through the conduit and be dispersed there by the swirling effect in the tangentially inflowing secondary air, thus becoming more easily inhaled. Preferably, this secondary air, which is inhaled to promote dispersion of the powder, represents approximately 75% of the total airflow. This means that about 25% of the total amount of airflow is conducted through the conduit. Based on such a gas flow pattern, the drug is transferred vertically from the capsule chamber, via the gas duct and through a corresponding opening to a baffle, and then tangentially through another opening into the vortex chamber.

To prevent the medicament from falling out through the air inlet opening after the sachet chamber has been crushed when the inhaler is held vertically, a built-in web may be provided in the space immediately behind the opening, which web deflects the air flow path and distributes it in a labyrinth fashion. To further prevent the medicament from being carried out of the inhaler by the air flow blown into the mouthpiece, a check valve may preferably be provided at the air inlet opening of the powder conduit, which may open when the housing cavity is at a low negative pressure and close when the housing cavity is at a normal or over-pressure. One useful check valve is a diaphragm valve, wherein the diaphragm is positioned inside the housing, covers the air inlet opening, and abuts against an end face thereof and closes the air inlet opening when the interior of the housing is in an overpressure condition. A spring-loaded ball valve or other check valve may also be used to close the inlet opening.

The inhaler housing according to the present invention may have one or more additional recesses or pockets to accommodate one or more backup sachets.

Preferably, the inhaler may be made of plastic; suitable materials are, for example, thermoplastic materials such as polyoxymethylene (polyaldehyde) alone or in combination, polycarbonate, polymethyl methacrylate, polypropylene, polyethylene, polyvinyl chloride and acrylonitrile-butadiene-styrene (ABS). Elastomeric polymers with elastomeric properties are suitable for use in designing webs for securing the blister strips.

Sachets made of a variety of materials may be used in an inhaler according to the present invention. Preferably, the container film is made of a thermoformable polymer such as polypropylene, polyethylene, polyvinyl chloride, polystyrene, or a deep drawable metal such as aluminum, with additional polymer lamination. Other heat deformable materials commonly used for sachet packs are also suitable. In the case of a container film having a cavity portion formed by thermoforming from these materials, the cavity portion and the other portions will have uniform film thicknesses. Of course, the material used for the other parts of the container film and the like may be injection molded or other plastic materials, or may be blow molded materials, such as elastic materials and the like, and the part having the cavity may be formed by injection molding or blow molding, respectively. In this case, the thickness of the film at different parts of the container film will be arbitrarily variable. Preferably, the wrapping lobes are made of a metal material such as aluminum or aluminum alloy with a laminated polymer added thereto. Other materials may also be used, including those conventionally used and mentioned above for sachet packs. The wrapping flaps may be attached to the container film in a variety of ways, such as by conventional welding or bonding. In addition, inhalers according to the present invention may also employ a sachet pack in which each of the pockets is surrounded by a circumferential weld moulded from the container film. Such a sachet pack is advantageous in that it further reduces the mechanical load to which the drug is subjected during the compression-release process.

The present invention provides a powder inhaler using a sachet pack, which is easy to handle and provides the user with a form of medicament that is sufficiently dispersed and thus easily inhaled.

Drawings

The invention will be described in connection with various embodiments illustrated in the following figures.

Fig. 1 shows in perspective view an inhaler whose squeeze-release device is designed as a one-piece lever.

Figure 2 is a cross-sectional view of the inhaler of figure 1 showing the housing and sachet cavity in cross-section, having been flipped open.

Figure 3 is a cross-sectional view of the inhaler shown in figure 1 with the housing inverted closed and the sachet cavity inserted.

Figure 4 is a cross-sectional view of the inhaler of figure 1, wherein the unitary lever has been depressed.

Fig. 5 shows in perspective view an inhaler with four independent squeeze-release levers turned open and its bottom section housing turned down.

Figure 6 is a cross-sectional view of the inhaler shown in figure 5 with the housing closed and the sachet cavity inserted.

Fig. 7 shows an inhaler in perspective view with four centrally located squeeze-release aids and the upper housing turned open.

Figure 8 is a longitudinal section through the sachet inhaler of figure 7, with the housing closed and the sachet cavity inserted.

Figure 9 is a cross-sectional view of the inhaler shown in figure 8.

Figure 10 shows the inhaler of figure 9 wherein the squeeze-release punch has been depressed.

Detailed description of the invention

All the inhalers shown are suitable for use with a sachet strip having four sequentially arranged sachets which can be sequentially emptied by the user and their contents inhaled.

In the embodiment of the invention shown in fig. 1, the squeeze-release device is designed as a single lever which at the same time also constitutes the upper housing 2. The upper section shell 2 is connected with the bottom section shell 3 through a film hinge, and the upper section shell 2 is lightly connected to the upper side of the bottom section shell 3 in a closed state. The mouthpiece 1 is shaped substantially like a truncated cane and is attached to the narrow end of the base section housing 3. The approximately rectangular finger grip plate 4 of the squeeze-release punch 10 (not shown in fig. 1) is fitted into a rectangular recess 27 on the single lever formed by the upper housing 2. The gripper plate 4 is displaceable in the groove 27, which makes it possible to fix the gripper plate in the a, b, c or d position by means of a corresponding recess 28 in an engaging manner. Before the inhalation action is performed, the movable squeeze-release punch 10 has to be pushed with the gripper plate 4 onto the side of the still unempted capsule cavity 31 (not shown in fig. 1), i.e. the squeeze-release punch 10 is brought into one of the four squeeze-release positions a, b, c or d by the engagement described above. The capsule chamber 31 on the underside of the squeeze-release punch 10 is ruptured by pressing down on the upper housing (single lever) 2. In this embodiment of the inhaler, the single lever formed by the upper housing 2 provides a wide active surface, so that the operation of crushing the capsule cavity 31 can be performed not only with the index and the thumb, but also with the entire palm of the hand. In order to prevent slipping, the acting surface is also provided with anti-slip grooves 35 which are distributed longitudinally. The arcuate recesses 36 on the upper housing 2 and the anti-slip grooves 35 on the lower housing 3 facilitate opening of the housings. In the engaged state, the housing is held in the closed state by pins 42 which engage in the cut-out sections 41 of the mouthpiece 1 and the base housing 3. The pin 42 is fastened to the upper housing or to the individual lever formed by the upper housing 2, which can be pushed down into the cutout 41 when the individual lever formed by the upper housing 2 is tilted down. Thus, to avoid the single lever formed by the upper housing 2 from flipping upwards, the rotatable mouthpiece 1 is rotated through about 30 °. The shells can be prevented from opening by sliding between the inner wall of the mouthpiece 1 and the ends of the pins 42, while the single lever formed by the upper shell 2 can still be pressed down to rupture the capsule cavity 31. To open the housing, the mouthpiece 1 can be rotated back into place in the opposite direction, thereby exposing the notched portion 41 on the mouthpiece 1 to the pin 42 on the individual lever formed by the upper housing 2 and flipping the individual lever formed by the upper housing 2 upwards.

The sectional views shown in fig. 2 to 4 show the internal configuration of the housing. The inside of the bottom section shell 3 is provided with a bearing seat of a medicine sac strip 5, and the bearing seat comprises two clapboards which are distributed longitudinally and point to the upper side in a V shape. In addition to the longitudinal partitions shown in cross-section, the carrier 29 also has two corresponding transverse partitions on the short sides of the housing, so that the inserted blister strip 5 can rest on all four sides of the carrier 29. The upper part of the partition of the carrier 29 is slightly widened to provide a sufficient abutment surface for the strip 5 of sachets; furthermore, the widened top end of the partition has a shallow and inwardly directed rectangular recess 30, into which the sachet strip 5 can be inserted, without the sachet strip 5 thereby slipping into the interior of the carrier 29. The conduit 7 passing through the housing in the longitudinal direction is located in the lower part between the V-shaped arranged partitions in the carrier seat 29. The conduit 7 connects the mouthpiece 1 to an air inlet, the mouthpiece 1 being shown in the perspective view of figure 1, whereas the air inlet is not shown in this embodiment. The partition of the carrier base 29 and the inner wall of the bottom shell 3 enclose two chambers 34 which are distributed to the left and right and are separated by the guide tube 7 and in which a cartridge strip 5 (so-called "spare cartridge strip") for later use can be stored.

Fig. 2 to 4 show the punch 10 integrally joined with the grip sheet 4 and having a concave curved blanking surface 37. The longitudinal sliding connection on the upper housing 2 is realized by a gripper plate 4. The portion 40 of the upper housing adjacent the film hinge acts as a built-in or body lever for the punch 10.

In the case of the single-handled inhaler shown in fig. 2, the housing is in an open state, i.e. its upper housing 2 is turned upwards, so that the strip 5 of sachets is placed on the carrier 29. In addition to the punch 10, the single-piece lever formed by the upper housing 2 is provided with two thin webs 6 distributed along the long sides of the recess 27 (see fig. 1) and pointing inwards, the ends 6a of which are remote from the inner surface of the upper housing 2 and have a curved shape suitable for being clamped around the bearing seats 29. A transverse web is provided between the opposed ends of the two webs 6. The webs 6 and transverse webs are made of resilient material so that when the upper shell 2 is pressed downwardly by the punch 10 engaging the sachet cavity 31, the webs can deform (flex) to press the sachet strip edge into the carrier seat 29 by virtue of their resilient force.

Figure 3 shows the inhaler in a first stage of the squeeze-release process, when the housing is closed and the strip 5 of sachets has been inserted. From this figure it can be seen that the resilient web 6 engages the upper end of the carrier 29 and the sachet strip 5 is inserted therein. The web 6 is already under stress from the pressure exerted by the user (not shown in this figure) from the upper side on the single lever formed by the upper housing 2. According to one embodiment, the web 6 presses all four sides of the blister strip in the tensioned state firmly against the carrier base 29, so that a strong tightness against the outside air is achieved by the fastening of the blister strip 5. The punch 10 is laterally connected to the bottom housing 3 by means of a built-in lever arm 40 so that, when the top housing is closed, the punch 10 will follow an arcuate path around the fulcrum of the top housing 2 so that the engagement of the edge of the curved punching surface 37 on the convexly curved capsule cavity 31 will be asymmetrical, i.e. only a single edge engagement will occur first during the first stage of the squeeze-release process. At the stage of the press-release process shown in fig. 3, the upper shell 2 is slightly engaged on the upper side of the lower shell 3.

Figure 4 shows the final stage of the compression-release process when the sachet cavity 31 has ruptured and has been emptied. Compared with fig. 3, the web 6 is stressed more greatly, and the upper shell 2 is tightly jointed on the lower shell 3. The medicine bag cavity 31 is crushed by the punch 10; the wrapping flaps previously sealing the sachet cavity 31 remain attached to the sachet strip 5 only on one side and hang down as a flap 8 aligned parallel to the air flow inside the conduit 7. The asymmetric engagement of the punch 10 on the sachet cavity 31 causes the wrapping lobe to split first on the side where it first engages the curved die cut surface 37. In figure 4, the medicament 38 falls directly from the ruptured capsule chamber 31 into the airway tube 7, from where it 38 is accessible to the user for a subsequent inhalation. The bold arrows in fig. 4 are meant to more clearly illustrate the point of action of the force exerted by the user during the squeeze-release process. The lever transmission has the effects that: the force required to rupture the capsule cavity 31 will be about half less than if it were to be ruptured directly. When all four pockets 31 of the sachet strip 5 are emptied, the housing must be opened and a new sachet strip 5 inserted.

Fig. 5 and 6 likewise show an embodiment of the inhaler in which the press-release device is acted upon by a lever arm. However, in this embodiment, instead of a single lever formed by the upper housing 2 provided with a movable squeeze-release punch 10, the inhaler has four separate squeeze-release levers 9, each lever 9 having its squeeze-release punch 10, each punch crushing the four capsule chambers 31 by sequential action. Fig. 5 shows the four lever type inhaler with the housing opened about the fulcrum. The bottom section shell 14 is connected in a reversible manner to the middle section shell 13 by means of suitable hinges 17, the hinges 17 being attached to the long sides of the middle section shell 13. The four squeeze-release levers 9 are also connected in a reversible manner to the middle section housing 13 by means of suitable hinges 16, the hinges 16 being located on the opposite long side of the middle section housing 13. The upper side of the middle section housing 13 acts as a support for the sachet strip, where the middle section has a rectangular recess 30 for receiving the sachet strip 5. The bottom of the rectangular recess 30 is formed with four drug-filling openings 20 which communicate with the airway tube 7 when the housing is closed, which is not shown in fig. 5. A mounting plate 18 for the mouthpiece 1 is attached to one narrow end of the mid-section housing and a mounting plate 19 for the tip 15 is attached to the opposite narrow end. A swirl chamber 11 with tangential inlet slots 12 is made in a mounting plate 18 for the mouthpiece 1. The mouthpiece 1, which is composed of a cylindrical section and a frusto-conical section, is secured to the mounting plate 18 and its cylindrical portion encloses the swirl chamber 11. In order to allow the secondary air flow to enter the swirling flow chamber 11 through the air inlet channel 12, the mouthpiece 1 is provided with a secondary air duct, which will not be described in detail herein. The end piece 15 is provided with an air inlet opening, which is not described, and the mounting plate 19 is fixedly connected with a diaphragm valve. The airway tube 7 runs inside the reversible bottom shell 14 and, once the shell is closed, the airway tube 7 is sealed to an airtight level by means of corresponding welds 25 running longitudinally along the tube. When the bottom section casing 14 has been opened, the conduit 7 is opened and thus facilitates cleaning. When the housing is closed, the conduit 7 will lead the air inlet opening to the mouthpiece 1 through corresponding openings in the mounting plates 18 and 19.

After the sachet strip 5 has been inserted into the middle section housing 13, the housing will be closed by flipping over, specifically, first slightly flipping down the four squeeze-release levers 9 that form the upper section housing, but now without applying pressure to the sachet cavity 31, and then flipping the bottom section housing 14 up. Fig. 6 is a sectional view of the four lever type inhaler which is turned over to be closed. The end of the bottom-section housing 14 opposite the hinge 17 is bent upwardly so that in the inverted closed position it will snap around the lower portion of each squeeze-release lever 9 and this snap connection maintains the housing in the closed position. The upward bending manner of the bottom-stage casing 14 and the shape of the squeeze-release lever 9 have the following features: when the housing is closed, the punch 10 will exert a slight pressure on the capsule cavity 31, thereby holding it in place in the rectangular recess 30, but not so much pressure as to rupture the capsule cavity 31. With the squeeze-release lever 9 resting on the sachet strip 5, its fixation to the sachet strip 5 will ensure that it does not trip or migrate in the closed state of the inhaler. The curved shape of the bottom section shell 14 also means that the bottom section shell 14 only needs to be closed by turning it upwards, so that the squeeze-release lever 9 automatically enters the position shown in fig. 6. The manner in which the two longitudinal welds 25 pressing on the middle section shell 13 act as a lateral seal for the conduit 7 is clearly seen in fig. 6. Thus, if the user desires to inhale a dose of medicament 38 enclosed within the capsule cavity 31, he must press down on one of the four squeeze-release levers 9, preferably in a lever force-transmitting manner with the end remote from the hinge 16 as the point of application, the punch 10 thus exerting pressure on the capsule cavity 31 via its curved punching surface 37, thereby crushing the latter. The bold arrows in the figure indicate such preferred points of application of force by the user on the lever 9. As can be seen in fig. 6, in this embodiment the built-in lever arm 40 is connected transversely to the intermediate housing 13, and the arrangement of the punch 10 on the lever arm 40 is characterized by a specific tearing of a point on the wrapping lobe 39, so that the manner of engagement with the capsule cavity 31 is also asymmetrical. In this way, the medicament can fall through the filling opening 20 into the conduit 7 and be sucked away there. To release the next dose of medicament, a further squeeze-release lever must be pressed downwards. The squeeze-release lever 9 in this embodiment is significantly narrower than the single lever formed by the upper housing 2 in the above-described embodiment, and the manipulation of these levers must be individually performed, and therefore, the user should press the squeeze-release lever 9 downward with a finger. As with the single lever design concept, in this embodiment the force required to rupture the capsule cavity 31 is about half less than that required by direct lever actuation. A particular advantage of this embodiment is that the task of cleaning the powder conduit 7 and the drug loading opening 20 is easy to handle when the housing is turned over.

Figures 7 to 10 show another embodiment of the inhaler in which the squeeze-release mechanism acts directly rather than in a lever-actuated manner. As can be seen in fig. 7 and 8, the inhaler comprises an elongate bottom housing 3 with a mouthpiece 1 and an end piece 15, and an upper housing, here in the form of a flap cover 23 integral with a squeeze-release punch 10. When the flap cover 23 is closed, the entire housing is substantially tubular. The flap cover 23 is connected to the end piece 15 of the bottom section shell 3 by means of a hinge 24. A rectangular recess 22 is provided in the flap cover 23, in which four squeeze-release punches 10 with their gripper plates 4 are accommodated. Also provided in the bottom section housing 3 is a rectangular recess 30 which serves as a support for the blister strip 5. The bottom of the rectangular recess 30 is provided with four drug-filling openings 20 communicating with the powder duct 7, of which duct 7 is not shown in fig. 7. The closed flap closure 23 will nest in the rectangular recess 30 of the bottom section housing 3 and thereby secure the inserted sachet strip 5. The air inlet opening 32 is located on the end piece 15, in which a diaphragm valve 21 is provided to allow air to be drawn into the inhaler. The mouthpiece 1 has a cylindrical section and a frusto-conical section. A swirl chamber 11 provided with tangential inlet slots 12 is nested within the cylindrical section of the mouthpiece 1. In use, the medicament 38 is rapidly dispersed by the airflow inhaled through the mouthpiece, and the dispersed medicament passes through the airway tube 7 and reaches the baffle 44 through the opening 43. Where the drug is separated into smaller particles and then enters the vortex chamber 11 tangentially. The secondary air flow entering the swirl chamber 11 via the inlet channel 12 is provided by a secondary air duct 26, seen only in longitudinal section in figure 8, which duct 26 is provided in the flap housing 23 and is identical to the internal chamber of the mouthpiece 1.

The embodiment of the inhaler shown in figure 7 has a direct acting squeeze-release mechanism, in which the flap 23 is opened and a punch 10 is depressed, and in which the inhaler also has no blister strip 5 inserted, while the cross-sectional view shown in figure 8 clearly shows the position of the blister strip in the housing and the manner of action of the squeeze-release mechanism. To empty the capsule chamber 31, the user can apply pressure with his fingers on one of the gripper plates 4 of the squeeze-release punch 10. Under the direct transmitted force, the concave curved die cut surface 37 will engage the sachet cavity 31, the wrapping lobe 39 will be torn and the medicament 38 will also fall through the filling opening 20 into the conduit 7 and be sucked therefrom. The torn packing lobe remains partially attached to the remaining packing lobe 39 and hangs as a flap 8 into the drug-filling opening. Fig. 8 does not show how the respective press-release punch 10 and its gripper plate 4 are assembled in the hinge cover 23. However, the possibility exists that the press-release punch 10 is loosely fitted within the flap closure 23 and that the punch 10 will only be held in the up position when the sachet strip 5 has been inserted and the curved punch surface 37 of the punch bears against the sachet cavity 31. It goes without saying that the squeeze-release punch 10 must be so light that the capsule cavity 31 is not damaged when it lands on the capsule cavity 31 and the user exerts no pressure on the grip plate 4. To avoid accidental loading of the capsule cavity 31, a restraining connection may also be used to hold the squeeze-release punch 10 in place. These restraining connections can be easily released when pressure is applied by the user. Furthermore, a spring-mounted manner of the press-release punch 10 is also possible.

Figures 9 and 10 are cross-sectional views of the inhaler shown in figures 7 and 8, according to a design in which the squeeze-release punch 10 engages the sachet cavity in an asymmetrical manner. The angle of the cutting edge of the curved surface 37 relative to the longitudinal axis of the punch 10 is not visible in the longitudinal section shown in figure 8. If this angle is not equal to 90 deg., the cutting edges will always intersect in a plane perpendicular to the longitudinal axis of the housing, i.e. the direction of the gas flow, so that the cross-section of the punch is designed asymmetrically in a direction transverse to the longitudinal axis of the housing. Only then, after the squeeze-and-release action has taken place, the cracked wrapping lobes and debris 8 are assured of being aligned in a direction parallel to the airflow and do not block the airflow. This will be further explained in connection with fig. 9 and 10. Figure 9 shows the inhaler when the flap closure 23 has been closed and the strip 5 has been inserted, the asymmetrical cross-sectional shape of the squeeze-release punch 10 being achieved by the cutting edges of the curved surface 37 of the punch 10 lying in a plane which is at an angle unequal to 90 ° to the longitudinal axis of the punch and which intersects a vertical plane lying longitudinally along the housing. The curved surface 37 engages around this part to a higher degree than the other part for the corresponding surface on the capsule cavity 31, so that the wrapping lobe 39 will be torn first by the punch 10 at its intended location. The sachet strip 5 is pressed on the bottom section shell 3 by the elastic web 6, thereby realizing the sealing of the airtight grade. The cross-section of the squeeze-release punch 10 is asymmetrically shaped so that one side of the container film 33 is stretched more during squeeze-release (fig. 10), and the wrapping flaps 39 will here tear towards the lower side of the container film 33, which is more stressed, and will still be attached to the remaining wrapping flaps 39 on the opposite side. The medication 38 falls through the fill opening 20 into the airway tube 7. The debris 8 surrounding the lobes 39 will align in a direction parallel to the air flow and extend directly into the airway tube 7 when hanging into the fill opening 20.

Claims (11)

1. Inhaler for administering a powder medicament (38) from a strip-shaped medicament capsule (5), the medicament capsule (5) comprising a container membrane (33) and a wrapping flap (39), wherein the container membrane (33) has an array of individually distributed convexly curved medicament capsule cavities (31), the cavities (31) having a spherical crown shaped curvature for receiving the powder medicament (38) and the wrapping flap (39) enclosing the cavities (31), the inhaler having an elongated housing with at least two housing parts (2, 3, 9, 13, 14, 23) which are connected to each other in an inverted manner by means of a joint or hinge (16, 17, 24), and wherein one of the housing parts has a recess (30) as a bearing (29) for receiving the medicament capsule strip (5), and wherein one narrow end of the housing is provided with a mouthpiece (1) and the opposite narrow end is provided with an air inlet opening (32), between which is provided an airway tube (7) adapted to receive medicament (38) from a blister strip (5) inserted into the support portion (29) directly from a blister cavity (31) of the blister strip in such a manner that a wrapping lobe (39) of the inserted blister strip (5) abuts the airway tube (7) and the housing has means for rupturing the respective blister cavity (31) of the blister strip (5), characterised in that: the press-release device for crushing each capsule (31) has at least one punch (10), the punching surface (37) of the punch (10) having a concave curved shape corresponding to the convex curved shape of the capsule (31), the press-release device being designed such that the cutting edge of the concave curved punching surface (37) of the at least one punch (10) will engage in an asymmetrical manner on the corresponding curved surface of the convex curved capsule (31) as seen in a direction transverse to the longitudinal axis of the housing, so that the flap (8) of the ruptured wrapping lobe (39) will sag in a manner that it will not obstruct the air flow inside the airway tube (7).

2. The inhaler of claim 1, wherein: the housing has an elongated bottom section (3) and an upper flap housing part (23), the bottom section (3) having a mouthpiece (1) and an end piece (15), and the upper flap housing part (23) being connected to the end piece (15) of the bottom section (3) by means of a hinge (24), and the press-release device having at least one press-release punch (10) with a concave curved punching surface (37) and a gripper plate (4) at its opposite end, whereby the press-release device is assembled in the upper flap housing part (23) of the housing and wherein no lever force transmission means are provided for transmitting a force to the press-release punch (10) during the press-release process.

3. The inhaler of claim 1, wherein: the press-release means are four press-release punches (10) mounted on the upper casing (23) by means of gripper plates (4) and, with the casing closed and the sachet strip (5) inserted, the above-mentioned press-release punches (10) can be pressed down individually against the outer curved sachet cavity (31) of the sachet strip (5).

4. The inhaler of claim 1, wherein: the housing has at least an upper housing part (2, 9) and a lower housing part (3), and the upper housing part (2, 9) is designed as a press-release device with a lever force-transmitting device which can transmit a force to the press-release punch (10) during the press-release process.

5. Inhaler according to claim 4, characterized in that the squeeze-release means is formed as a single lever (2) with a movably coupled squeeze-release punch (10).

6. Inhaler according to claim 4, characterized in that the squeeze-release means are a plurality of levers (9) each having a respective squeeze-release punch (10).

7. The inhaler of claim 1, wherein: the upper casing (2, 23) is provided with inwardly directed webs (6) of an elastic material, which serve to press the blister strip (5) against the carrier seat (29) in order to secure the blister strip (5) in a recess (39) in the closed inhaler.

8. The inhaler of claim 1, wherein: the punch (10) has a concave curved piercing surface (37) with cutting edges lying in a plane which is at an angle unequal to 90 degrees to the longitudinal axis of said punch (10) and which intersects a vertical plane lying longitudinally along the housing, whereby the punch (10) engages the capsule cavity (31) in an asymmetrical manner.

9. The inhaler of claim 1, wherein: the press-release punch (10) has a concave curved punching surface (37) with a cutting edge, and the punch (10) is laterally attached to the housing by a lever arm (40) in such a way that depression of the punch (10) by a user will cause a movement in an arc about the pivot axis of the lever (40) such that the action of the curved surface (37) cutting edge engaging the capsule cavity (31) occurs first on one side thereof.

10. The inhaler of claim 1, wherein: the mouthpiece (1) has a cylindrical section and a frusto-conical section, and the cylindrical section has a swirl chamber (11) with a tangential inlet channel (12) and a secondary gas duct (26) within it.

11. Inhaler according to claim 1, characterized in that a non-return valve is provided in the air inlet opening (32).