Inhalation device

(42) Date of commencement of the patent: 15.10.1995 (45) Date of issue: 28. 5. 1996

<td>(30) Priority:</td><td>(73) Patent owner:</td>

<td>2. 3.1990 GB 9004781 claims.</td><td>GLAXO GROUP LIMITED</td>

<td>(56) Documents:</td><td>W1Y 8DH LONDON (GB).</td>

<td>FR 2516387B WO 90 / 00496A1 EP 0129985A1</td><td></td>

(54) INHALER AND MEDICATION PACK THEREFOR (57) Disclosed is an inhaler and medicament pack (401) therefor, wherein at least one powder medicament container (402) is defined between two foils (403, 404) which are peelably secured together are. The inhaler has a peeling device for releasing the foils from each other in an opening station to open the container, and an outlet (420) communicating with the opened container and through which a user inhales the powdered medicament from the opened container can.

<img file="AT401007B_D0001.tif" />

CQ

AT 401 007

INR 0079318

AT 401 007 Β

The invention relates generally to an inhaler device by means of which a user can inhale a drug in the form of a powder.

More particularly, the invention relates to an inhaler device for use with a medicament package in which at least one container for a medicament in powder form is defined between two parts separable from one another.

Inhalers have been proposed which can be used with blister packs containing the drug in powder form in the blisters or blisters. Such devices include a lancing member which prongs the blisters in sequence so that the drug can be inhaled therefrom. Such a device is disclosed in EP-A1-129985.

Another inhaler described in FR-PS 2 516 387 is used together with an elongate carrier in the form of a band on which are mounted groups of microcapsules containing a volatile active ingredient. The apparatus includes means for disrupting the microcapsules to release the active ingredient in an air path for inhalation, and means for transporting the carrier to deliver fresh groups of microcapsules to the means for fracturing.

WO-A1-90 / 00496 describes a delivery device in which medically active substances are contained in a small bowl made of an adsorbent air-permeable material and closed by a lid of the same material. The outside of the lid is covered with an adhesive layer, which is covered with a removable protective film. To activate the dispenser, the microcapsules are crushed by manual pressure on the bowl and the active substance is adsorbed by the bowl material for evaporation. The dispenser can then be placed under the nose of the user by means of the adhesive layer after the removable protective film has been removed.

None of these publications discloses a device or package containing a powdered medicament contained in blisters and released for inhalation by peeling off a foil lid.

The object of the invention is to provide an inhaler device with an embodiment which makes it possible to use a medicament pack containing a large number of discrete unit doses without the device becoming unacceptably large.

The inhaler according to the invention of the type mentioned above is characterized by an opening station for the at least one container, by a peeling device for withdrawing the parts from each other in the opening station to open the container , and through an outlet communicating with the opened container through which User can inhale the drug in powder form from the opened container. The peelable portions of the drug package are preferably film parts, in particular elongated, strip-shaped film parts defining a plurality of drug containers, which are arranged in the longitudinal direction of the film parts at intervals, wherein a switching device for indexing the container in order to the opening station provided is. The medicament containers are in particular formed by pockets in a base foil, which is covered by a cover foil, and the two foils are removable from each other by means of a drive device in the opening station. In this way, a simple opening of the drug container is achieved, at the same time a feed movement is provided for the drug package, so that overall the mechanism of the inhaler can be extremely simple and space-saving. For example, it is particularly favorable here to provide a cover film drive device for removing the cover film. For incrementally advancing or indexing the drug package may simply be provided with a rotatable ratchet wheel with recesses, which can be brought into engagement with the drug package, each recess in the ratchet wheel receives one of the pockets of the drug package. It is particularly advantageous in this case if the ratchet wheel and the cover film drive device are connected to one another, their rotations being correlated with one another. It is also favorable for the operation when the ratchet wheel and the cover film drive device are interconnected by a slip clutch. It is also structurally advantageous, when the slip clutch is movable with the ratchet wheel, a toothed surface having gear member and a movable with the cover film drive means further gear member, which also has a toothed surface, which is in engagement with that of the first-mentioned Getriebegiiedes, wherein at least one of the toothed surfaces has a toothed portion, which is movable relative to its other toothed surface back and forth. On the other hand, it is also advantageous if the slip clutch has a movable with the ratchet coupling part and a movable with the cover film drive means coupling part, wherein one of the coupling parts an annular tooth arrangement and the other of the coupling parts engagement means for entrainment engagement with the

AT 401 007 Β

Toothing has when a force is applied smaller than a predetermined force between the coupling parts, whereas the engagement means slips relative to the toothing when a force equal to or greater than the predetermined force is applied.

It is also favorable for receiving the peeled cover sheet when the cover film drive means comprises a wheel, on which the cover sheet is rolled up, and which has a rolling surface, the diameter of which can be reduced with increasing tension in the cover sheet. It is further mechanically advantageous if the wheel has a plurality of resiliently flexible arms which extend away from it at an angle to the radius.

It is also advantageous if the indexing means is engageable between adjacent pockets for sequentially bringing the pockets into position in communication with the outlet.

Furthermore, it has proven to be structurally favorable if the cover film drive means comprises a pair of drive wheels which engage the cover film between them in drive engagement. The drive wheels may be toothed wheels with intermeshing teeth.

Another, advantageous for the operation embodiment is characterized by guide means for the cover sheet and the base sheet to guide along separate paths at the opening station, wherein the paths reunite after the opening station, and wherein the drive means is arranged behind the point where reunite the paths and drive both the coversheet and the base film. It is also advantageous if the drive means comprises a pair of toothed wheels with intermeshing teeth.

A further embodiment, which is preferred in terms of its rational operation, is characterized by at least one chamber for receiving the elongated medicament pack prior to opening and for receiving the base foil and the cover foil after peeling from one another. It is also advantageous if the elongated Medikamtentenpackung and / or the base film are held in rolled form by resilient winding former / is.

Advantageously, a display device for displaying a next stage of the device which can be operated in several stages is also provided, as soon as a preceding stage has ended. In this case, it is also advantageous if the display device has a display element which carries a plurality of labels, each representing an instruction for the user, and which is movable in execution of a given stage to show the label relating to the next stage ,

The invention also relates to a medicament pack, which is particularly suitable for use in an inhaler as indicated above, and this medicine pack is characterized by an elongated strip, through a base film, along the wells are provided at intervals from each other, and formed by a cover sheet, hermetic to the base film, but is peelably sealed, to define a variety of containers, each containing an inhalable drug in powder form. The strip is preferably sufficiently flexible so that it can be wound into a roll. In order to facilitate the mutual separation or removal of cover film and base film, it is also advantageous if the cover film and the base film have front end portions which are not sealed together. It is further favorable, if at least one of the front end portions can be attached to a retractor and hiezu designed accordingly. The hermetic seal between the base film and the cover sheet also preferably extends over the entire width of the strip.

The invention will be explained below with reference to embodiments illustrated in the drawings. Show: 1 a rear view of a first embodiment of an inhaler: Fig. 2 in an exploded axonometric view of the components of this inhaler according to FIG. 1; the Fig. 3a, 3b and 3c in an axonometric view, in a longitudinal section and in an end view (partially broken away) one in the inhaler according to FIG. 1 and 2 used clutch; the Fig. 4a and 4b in an axial section and in a cross section - on an enlarged scale compared to FIG. 1 and 2 - a mouthpiece used in the inhaler according to FIGS. 1 and 2 (but also with modified inhalers) can be used; FIG. 5 a front view of another inhaler, with a lid removed to illustrate the interior of the inhaler; FIG. 6 a rear view of this inhaler, the inside of which is shown; FIG. 7 an axonometric front view of this inhaler according to FIG. 5 and 6; FIG. 8th an axonometric rear view of this inhaler; FIG. 9 an axonometric exploded view of the components of this inhaler; FIG. 10 a front view of a third inhaler, wherein the internal structure thereof is shown; FIG. 11 on an enlarged scale, an axial sectional view of the mouthpiece of this inhaler according to FIG. 10; FIG. 12 a bottom view of this inhaler; the Fig. 13 to 16 a fourth inhaler, wherein Fig. 13 is a bottom view, Fig. 14 a sectional view along the line AA in Fig. 13 is, Fig. 15 a longitudinal section

AT 401 007 Β according to the line BB in FIG. 13 is and Fig. 16 is an exploded view on a smaller scale; the Fig. 16a to 16d this fourth inhaler in successive stages, and Fig. 16e is a sectional view along the line AA in Fig. 16a; the Fig. 17 20 shows a fifth inhaler according to the invention, FIG. 17 shows an end view, Fig. 18 a section along the line AA in Fig. 17 is, Fig. 19 a section along the line BB in Fig. 17 is and Fig. 20 is an exploded view; the Fig. 21 24 shows a sixth embodiment of the inhaler according to the invention, FIG. 21 is an end view, Fig. 22 a sectional view along the line AA in Fig. 21 and FIG. 23 a section along the line BB in Fig. 21 is and Fig. 24 is an exploded view; the Fig. 25 29 shows a modified coupling which can be used in those embodiments of the invention where such is required, this coupling being shown in front view, top view, rear view and left side view as well as in an axonometric view; FIG. 30 an exploded axonometric view of another embodiment of a coupling; FIG. 31 an exploded axonometric view of yet another embodiment of the coupling; FIG. 31a shows a cross section through the in Fig. 31 shown coupling; the Fig. 32 to 34 consecutive positions in the operation of an inhaler according to another embodiment of the invention, in a rear view; and FIG. 35 a perspective view on a larger scale illustrating an embodiment of a drug package according to the invention.

The Fig. Figures 1, 2 and 3a to 3c show an inhaler in which a flexible strip 1 is attached as a medicament pack forming a plurality of pockets 2, each containing an inhalable dose of a powdered medicament. The strip 1 contains a base film or layer 3 in which bubbles or so-called. Blister are formed to define the pockets 2, and a cover sheet or layer 4, which is hermetically sealed to the base sheet 3, with the exception of the area of ​​the blister, wherein the seal is such that the cover sheet 4 and the base sheet 3 from each other can be solved or deducted. The foils 3, 4 are sealed to each other over their entire width, with the exception of their front end portions, and at the front end portions they are preferably not connected at all. The films 3, 4 are preferably made of a plastic-aluminum laminate, and they preferably adhere to each other by heat sealing. For example, the material of the coversheet may be a laminate made from 50g kraft paper / 12μm polyester (PETP) film / 20μm soft aluminum foil annealed 9g (per m²) peelable heat-sealable vinyl varnish (sealable to PVC), and the material of the base film 3 may be a laminate consisting of 100um PVC / 45 μm tempered soft aluminum foil / 25μ.m oriented polyamide. The varnish of the cover sheet material is sealed to the PVC layer of the base sheet material to provide the peelable seal between the cover sheet 4 and the base sheet 3.

The strip 1 shown has elongate pockets 2, which extend transversely to the strip longitudinal direction. This is expedient in that it is possible to provide a large number of pockets 2 on a given strip length. The strip 1 may for example be provided with sixty or one hundred pockets 2, but may also have any other suitable number of pockets 2.

The inhaler comprises a housing body 10 defining three storage chambers, namely a chamber 11 in which the strip 1 is initially received and from which it is dispensed, then a chamber 12 for receiving the spent part of the base film 3 and finally a chamber 13, in which the used part of the cover sheet 4 can be wound on a wheel 14. The chambers 11, 12 contain corresponding curved leaf springs 28 and 29, the purpose of which will be described in more detail below. The housing body 10 forms a further chamber 15, which receives a ratchet wheel 16. This ratchet wheel 16 has a plurality of grooves 17 which extend parallel to the axis of the ratchet wheel 16. The grooves 17 are arranged at a pitch equal to the distance between the center lines of adjacent pockets 2. The chambers 11, 12, 13 and 15 are closed by a cover 30. The chamber 15 communicates with the chambers 11, 12 and 13 via channels 31, 33 and 32 in connection.

The chamber 15 communicates with a slot 18, which in turn extends upwardly into the interior of a mouthpiece 20. The slot 18 also communicates with air inlets, as described below in connection with the embodiment shown in FIGS. 4a and 4b special mouthpiece will be explained. The mouthpiece 20 is provided with additional air inlets 21, here shown in the form of two circular openings, although they may also have a different shape, such as in Figs. 4a and 4b is shown. The main purpose of the additional air inlets 21 is to provide additional air to the user to reduce resistance to inhalation, although they may also serve one or more other purposes, such as the mouthpiece of FIG. 4a and 4b is the case and will be explained in more detail below with reference to these figures.

Then, a device is provided, with which the user can turn the ratchet wheel 16 and the cover film 14 in stages in predetermined font sizes. This device has a latch 4

AT 401 007 Β wheel 22 and a gear 23, wherein both wheels are connected to be rotated together with the ratchet wheel 16, and further a lever 24 is arranged, which is about the same axis as the ratchet wheel 22 and the gear 23, however is independently pivotable thereof, and a gear 25 meshes with the gear 23 and is adapted so that it can rotate with the cover film 14. The lever 24 carries a slider arm 26 whose end is adapted to engage with the teeth of the ratchet wheel 22 in engagement. The teeth of the ratchet wheel 22 are also in engagement with a pawl 27 which is fixedly mounted in the housing body 10. For reasons that will become apparent from the following description of the operation of the present inhaler, the gear or gear 25 is not directly connected to the cover film 14, but via a slip clutch 50 which is received within the cover film 14. By providing this slip clutch 50, slip may occur between the cover film wheel 14 and the gear 25 when the force required to rotate the cover film wheel 14 exceeds a predetermined value.

The slip clutch 50 includes a washer 51 provided with a radially extending serration 52 or other surface roughness held by a compression spring 54 in engagement with a similar serrated or rough surface 53 provided on an end face of the cover film wheel 14 is. The compression spring 54 is supported at one end on an inwardly directed surface 55 of the cover film 14 and at the other end on a nut 56 which is screwed onto a bolt 57.

The device described above may be configured as a reusable device so that it can be reused after dispensing all drug doses contained in the pouches 2. In this case, provision may be made for the user to gain access to the interior of the apparatus, such as by removing the lid 30 so as to insert a fresh strip 1, such as in a cassette. On the other hand, however, the device may also be designed as a disposable unit, which, when the strip 1, with which it is equipped, was used up, is thrown away.

In any case, the first use of the device, the strip 1 is held within the chamber 11 in a relatively tight role by the leaf spring 28, wherein a short portion at the front end thereof out of the chamber 11 out through the channel 31 to the ratchet wheel 16. The foremost part at the front end of the strip 1 is separated, so that the front end of the cover sheet 4 can be attached to the cover film wheel 14 and the front end of the base film 3 can enter the channel 33. The end of the cover sheet 4 is held in place on the cover sheet wheel 14 by means of a wedge 34, which sits in a press fit in a slot 35 in the wheel 14.

A person who wishes to use the device pushes the lever 24 counterclockwise, as shown in FIG. 1, so that the slider arm 26 drives the ratchet wheel 22 through an angle equal to the angular distance between two adjacent teeth. In this case, the ratchet wheel 16 is caused to rotate by an angle corresponding to the pitch of the grooves 17 thereof and thus according to the distance between two adjacent pockets 2 in the strip 1. This brings a pocket 2 opposite the slot 18 in the housing body 10 in position. Since the ratchet wheel 22 and the gear 23 move together, and since the gear 25 meshes with the gear 23, the movement of the lever 24 also leads to a rotation of the cover film 14th This pulls a sufficient portion of the cover sheet 4 from the base sheet 3 to expose the contents of the bag 2, which is brought into alignment with the slot 18.

As the user inhales through the mouthpiece 20, the airflow generated thereby entrains powder from the opened pocket 2, so that the powder is inhaled. One way in which this can be done, will be described below with reference to the mouthpiece of FIG. 4a and 4b explained in more detail. Each time this process repeats, another length of cover sheet 4 is wrapped around cover film wheel 14, and another length of base film 3 enters chamber 12 through channel 33. The leaf spring 29 therein ensures that the base sheet 3 is wound up and is not imposed on the wall of the chamber 12.

An effect of rolling up the cover sheet 4 on the cover sheet wheel 14 is that the outer diameter of this wheel 14 gradually increases together with the rolled sheet 4. If the slip clutch 50 were not used to connect the gear 25 to the cover film wheel 14, this would result in successive operations of the lever 24 rolling up ever longer pieces of cover film 4 onto the cover film wheel 14. However, the slip clutch 50 avoids this effect, the clutch 50 slips each time by an amount sufficient to ensure for each operation of the lever 24, the winding of exactly the same cover film length corresponding to the pitch of the pockets 2.

Figures 4a and 4b show a portion of the indexing wheel 16 with a pocket 2 therein in connection with a mouthpiece slightly different from the mouthpiece 20 of Figures 1 to 3, and generally

AT 401 007 Β 120 is designated. The mouthpiece 120 has air inlets 140, generally referred to above in connection with Figs. 1 to 3, and a central powder outlet 119, one end of which is open towards the pocket 2 and the other end into the mouth of the mouthpiece 120 opens.

When a user inhales through the mouthpiece 120, this results in a flow of air through the intakes 140 and out through the pocket 2 to the powder outlet 119 and out through the mouthpiece 120. Characterized in that the air flow is directed in this way through the bag 2, an effective entrainment of the powder is achieved in the air stream, with the result of an effective emptying of the bag. 2 The mouthpiece 120 is provided with additional air inlets 121, for example four in number as shown, which open tangentially into the mouthpiece 120. Upon inhalation, air is drawn into the mouthpiece 120 not only through the air inlets 140, but also through the air inlets 121, and the air entering through the inlets 121 creates a swirling airflow that effectively disperses the powder within the airflow and the extent the deposition of powder on the inside of the mouthpiece 120 to reduce. This effect also helps to break up any powder clumps in the blisters.

An alternative coupling arrangement is shown in Figs. 25-29. In this case, the ratchet wheel 16 and the cover film 14 have corresponding toothed gears 63 and 64, which are connected with them rotates. The direction of rotation is indicated by arrows in FIG.

The gear 63 has a toothed surface 65, the teeth of which are provided continuously around the entire surface 65 and at a constant pitch. In contrast, the gear 64 has a tooth surface 66, some of which are missing teeth, since radially extending slots 67 are provided. The circumferential width of each slot 67 on the surface 66 is equal to a pitch. The drawing shows three such slots 67, but instead, of course, more or less slots, eg a slot, two slots or more than three slots, be provided. On one side of each slot 67, above each slot 67, as viewed in the direction of rotation of the gear 64, a sector gear 68 is defined between the slot 67 and a narrow gap 69. The radially inner end of each gap 69 communicates with an aperture 70 such that each sector gear 68 is connected to the remainder of the gear 64 by only one arm 71. The gear 64, or at least those portions thereof that provide the arms 71, is made of a material that allows the toothed segments 68 to resiliently deflect and deflect circumferentially. The rest position of the sector gears 68 is as illustrated in the drawing, however, when a force is applied to one of the segments 68 in the direction of rotation of the gear 64, the sector gear 68 can move to close the gap 67 at the radially outer end. This has the effect that a tooth is not missing at the end of the slot 67, but at the end of the gap 69th

When the force exerted circumferentially on the gear 64 by the gear 63 is below a predetermined value, the gear segments 68 remain in their rest positions, and the gear 64 behaves exactly as if it had a continuous tooth surface such as the gear 63. However, when the load exceeds a predetermined value, each time a sector gear 68 meshes with the gear wheel 63, this sector gear 68 is moved circumferentially to close the slot 67 at its outer end and open the gap 69. This movement of the toothed segment 68 by a distance corresponding to the tooth pitch has the effect of slipping of the gear wheel 64 relative to the gear wheel 63 according to a tooth pitch. In this way, the arrangement shown is capable of allowing a total slippage of the gears 63, 64 relative to each other equal to a maximum distance equal to three times the tooth pitch per revolution, allowing a corresponding slippage of the cover foil wheel and the ratchet wheel relative to each other. Of course, by providing more or fewer toothed segments 68 than the three shown, a lesser or greater maximum slippage can be achieved.

The in Figs. 5 9 is intended for use with a strip 201 which is similar to the strip 1 used in the above-described inhaler device according to FIG. 1 to 3, with the exception of the spaces between the pockets (see explanation below). This second inhaler is similar in many respects to the first embodiment, and its components, insofar as they generally correspond to components of the first embodiment, are designated by the same reference numerals, increased by the number 200. The main difference between the two inhalers is that in the inhaler of FIG. 5 to 9 no ratchet corresponding to the ratchet wheel 16 is provided. Instead, advancing the strip 1 to ensure that each stroke of the lever advances the strip 201 by a distance equal to the pitch of the pockets is achieved by a resiliently flexible arm 250 terminating in a tooth 252 which extends between adjacent pockets intervenes. Each time the lever 224 is actuated, the arm 250 is resiliently depressed as a pocket slides past its tooth 252, and the tooth 252 then springs back into engagement

AT 401 007 Β the strip 201 at the back of the just-moved bag.

As in the case of the first embodiment, the diameter of the cover film wheel 214 gradually increases in operation when the cover film 204 is wound thereon. In this embodiment, since a slip clutch can not be used, the effect just described is compensated for by gradually increasing the distance of the pockets from each other toward the rear end of the strap 201.

Another difference is that in the inhaler of Figs. 5-9 the chambers 211 and 212 form a single composite chamber, unlike the separate chambers 11 and 12 of Fig. 2. However, this would not be so and at the first Inhalation device according to FIGS. 1 to 3, a single composite chamber could be used as well as in the inhaler according to FIG. 5 to 9 separate chambers could be used.

10 to 12 show a third embodiment, which is similar in many respects to the second embodiment, and components of this third embodiment, which generally correspond to components of the second embodiment are denoted by corresponding reference numerals, but adding 300 instead of 200 ,

One difference is that, instead of the cover foil wheel 214, two wheels 314a, 314b are used, the cover foil being caught in the nip between these wheels 314a, 314b, which act as a defect. These wheels 314a, 314b are knurled or otherwise roughened to enhance the grip between the wheels 314a, 314b and the cover sheet. The cover sheet used is not rolled up, but fed into a chamber 313, so that no problem occurs, as in the above embodiments, when attempting to wind up ever greater lengths of the cover sheet with continued operation of the device.

Fig. 11 shows the mouthpiece which is slightly different in shape compared to that of Figs. 4a and 4b. The mouthpiece shown has a single air inlet 340 instead of the two air inlets 140, and the powder outlet 119 of Figures 4a and 4b is replaced by a mouthpiece portion 319 of reduced width. Of course, the device according to FIGS. 10 to 12 could also be modified such that it contains a mouthpiece more similar to that according to FIGS. 4 a and 4 b.

FIG. 10 shows that the device is provided with a hinged lid 360, and such a lid could also be provided in the previous embodiments. FIG. 12 indicates that the device has a window 370 through which characters on the strip can be viewed. By printing the strip with numbers or other indicia related to the number of bags from which powder has already been dispensed, or which may still be dispensed, the user is provided with an indication of the number of cans already in use were or still remain. Another possibility is to use a dose counter which is driven by one of the rotating components of the inhaler. Of course, similar characters and means for providing information may be provided in all embodiments.

In Fig. 13 to 16, another inhaler is shown, which is similar in principle in its operation to the inhaler of FIG. 1 and 2, and accordingly, components thereof, which generally correspond to components of the first embodiment, with the same reference numerals, adding the Number 400, designated.

As in the first embodiment, the apparatus includes a flexible strip 401 having a base sheet 403 in which pockets 402 are defined and a cover sheet 404. The strip 401 is most clearly shown in FIG. 35 shown. The cover sheet 404 has a loop 404a formed at the front end thereof for engagement via a pin 471a extending upwardly from a toothed wheel 471, see FIG. the following description. The base sheet 403 has a reduced width front portion 403a for engaging in a slot 470a formed in a base sheet rolling wheel 470, as will be described in more detail below. The front end portions of the base sheet 403 and the cover sheet 404 are not sealed together, as shown in FIG. 35 is apparent.

The case body 410 has a base part 410a and a top part 410b, both of which have a general circular shape. When the device is assembled, the base and top are snapped together. The housing portion 410 defines a single internal chamber within which the strip 401 is received and within which also a wheel 414 for rolling up the spent portion of the cover sheet 404, the wheel 470 for rolling up the base sheet and a ratchet wheel 416 are provided. The ratchet wheel 416 is hollow, and within it a shift ratchet 422 is received. All the wheels just mentioned are rotatably mounted in the chamber defined in the housing body 410 relative thereto. A pawl 470b is secured to the housing body 410 and engages the teeth of the base sheet takeup wheel 470 to prevent this wheel 470 from moving counterclockwise, thereby ensuring that the strip 401 is moved through the apparatus only in the forward direction

AT 401 007 Β can.

The cover sheet rolling wheel 414 is formed in two parts, namely a toothed wheel 471 having teeth 472 and a shaft 473, and a compressible wheel 474 having a hollow central shaft 475 and a plurality of resilient arms 476, approximately eight as shown Arms, which extend from the central shaft 475 each at an angle to the radius. The toothed wheel 471 has a lug 477 which engages a corresponding notch in the shaft 475 so that the wheels 471 and 474 rotate together.

The hollow ratchet wheel 416 has outer teeth 478 that mesh with the teeth of the base sheet rolling wheel 470 and the teeth of the wheel 471. Ratchet teeth 479 are formed on the inner walls of the ratchet wheel 416, and the ratchet wheel 422 has two pawls 480 that engage the ratchet teeth 479.

Further, the apparatus includes a lever 424 having an arcuate wall 481 with a finger grip 482 and an arm 483 extending inwardly from the wall 481 and supporting an arcuate array of teeth 484 at its distal end. The lever 424 is pivotally mounted to the center of the base portion 410a for movement about an axis located in the center of the pitch circle of the teeth 484, the teeth 484 meshing with the teeth 485 on the switching ratchet wheel 422.

A suction member 486 provides communication between the chamber within the housing body 410 and a mouthpiece 420. The suction member 486 has a powder outlet 419 and a channel 487 to allow the cover film strip 404 to pass the compressible wheel 474. Optionally, a roller 488 may be provided to guide the strip 404 into the channel 487.

A dose monitoring ring 489 with teeth 490 is arranged to be rotated within the base portion 410a of the housing body. On its lower surface it bears marks (not visible in the drawing) which can be viewed by the user through a window 494 in the housing body 410. From Fig. 16a to 16d it can be seen that the window 494 can be seen both when a lid 491 is closed and when it is opened. The signs indicate either exactly or approximately the number of doses remaining (or the number of doses already consumed, if preferred). The ring 489 is rotated due to the fact that its teeth 490 are in engagement with the teeth 478 of the ratchet wheel.

The device is provided under the cover 491, which is pivotally mounted on the housing body 410 by means of a projection 492 on the upper housing part 410b and a corresponding projection 493 on the housing base part 410a. The lid 491 is pivotable between an open position (shown in Figure 14) in which the mouthpiece is exposed and a closed position in which the mouthpiece is not exposed, as will be explained in more detail below.

In operation, the user moves the lid 491 to its open position, and then presses on the finger grip 482 of the lever 424 to pivot the lever 424. As a result, the SchaltKlinkenrad 422, which causes the ratchet 416 via the pawls 480 to rotate. The rotation of the indexing wheel 416 causes rotation of both the base sheet rolling wheel 470 and the cover sheet rolling wheel 414 so that the base sheet 403 and cover sheet 404 are pulled apart by a distance sufficient to open a previously unopened pocket 402 opposite the end of the powder outlet 419 in Ansaugteii 486 exposed. The patient may then inhale through the mouthpiece as in the previous embodiments.

In the Figs. 16a to 16d are successive stages in the operation of the device of FIG. 14 to 16 shown. In Fig. 16a, the device is in its closed position. The finger grip 482 of the lever 424 is located in this step in a recess 482b formed in the housing body 410 (as shown more clearly in FIGS. 16b and 16c can be seen). The lid 419 is held stationary while the case body 410 is rotated counterclockwise, with a recess 410c provided in the peripheral part of the case body 410, so that the user can insert a finger for this purpose. The device is thus in the partially open position shown in FIG. 16b moves. During this process, the lever 424 remains stationary relative to the lid 491. This is achieved in that the lever 424 is internally provided with a resilient arm 424 a, the tip 424 b engages in a recess 491 a in the lid 491. The arm 424a is attached to the lever 424 via a cylindrical member 424c. As shown in FIG. 16a, the arm 424a extends counterclockwise away from the cylinder member 424c across an arc corresponding to an angle of approximately 90 °. The cylindrical member 424 c is guided in an arcuate slot 41 od, which is formed in the housing body 410. The slot 410d extends over an arc corresponding to an angle of approximately 180 ', and in FIG. 16a, the cylindrical member 424c is shown approximately in the middle of its longitudinal movement. In Fig. 16b he is illustrated at one end of his movement stroke.

AT 401 007 Β

The user then continues to remove the housing body 410 from the housing shown in FIG. 16b shown in FIG. 16c shown position to twist. During this further rotation, the tip 424b of the arm 424a springs out of the recess 491a. This is because the movement of the housing body 410, when the cylindrical member 424c is present at one end of the slot 41d0, entrains the cylindrical member 424c in a counterclockwise direction, and thus similarly forces the arm 424a to move counterclockwise. The user then moves the lever 424 by pressing on the finger grip 482 to rotate it counterclockwise through the finger grip 484 shown in FIG. 16c position shown in FIG. 16d shown position in which the finger grip 482 again enters the recess 482b. The steps described so far expose the mouthpiece 420 and also cause an opening of a fresh blister of the drug package. The device is therefore now ready for inhalation.

After use, the housing body 410 is rotated clockwise, with the lever 424 moving together with the housing body 410 to return the apparatus to the position shown in Figure 16a.

The compressible wheel 474 performs virtually the function of the clutch of the first embodiment. The more of the cover sheet 404 is wound on the wheel 474, the more the arms 476 gradually bend inwardly, and this effect serves to keep the outer diameter of the roll of the wound cover sheet 404 substantially constant, while gradually decreasing its inner diameter.

Instead of the wheel 414 with the compressible wheel 474, it is possible to use the alternative structure shown in FIG. 30 or those according to FIGS. 31 and 31a. The functional principle of the in Fig. 30 shown construction is very similar to that of the clutch assembly of FIG. 25 to 29. The structure according to FIG. 30 comprises two components 800 and 801. The component 800 includes a generally cylindrical, hollow housing 802 open at the lower end and three arcuate portions with teeth 803. The cylinder

802 has a slot 804 extending through its upper surface, and a columnar holder 805 for receiving the front end of the cover sheet. The component 801 has a disk 806 provided with three arc regions of teeth 807 and a part 808 projecting from it. The upstanding part 808 is made of a material, for example Kunststoffmateriai, which is resilient with respect to a rotation (torsion spring).

The two components 800, 801 are assembled by a snap connection so that the upper end of the part 808 is received in the slot 804 and can not rotate relative thereto. The tooth areas 803 and 807 are coplanar and alternate. The teeth 803 and 807 mesh with the teeth 478 of the ratchet wheel. Each tooth area 807 is from one of the adjacent tooth areas

803 (but not the other) separated by a gap equal to a tooth. Therefore, there are three gaps, each with the width of a tooth seen in the circumferential direction of the tooth areas. Since the upstanding member 808 can resiliently twist, the disc 806 can move freely back and forth between a position in which the gaps are respectively on the one side of a corresponding tooth portion 807, and a position in which the gaps on the on the other side of the tooth areas 807. This causes slippage of the in Fig. 30 shown arrangement relative to the ratchet wheel.

The in Fig. 31 illustrated structure is a slip clutch. It has two components 810 and 811, which sit in a snap fit into each other. The component 810 has a generally cylindrical housing 812 which is open at its lower end and has a columnar holder 813 for receiving the front end of the cover sheet. The interior of the housing 812 is provided with longitudinally extending serrations 814, as shown in FIG. 31a can be seen. The component 811 includes a cylinder 815 extending upwardly from a disc 816 provided with teeth 817. The teeth 817 mesh with the teeth 478 of the ratchet wheel. The cylinder 815 is provided on its outside with two bumps 818, which engage in the toothing 814. When the torque applied to the component 810 by the component 811 is below a predetermined value, the components rotate together. However, the cylinder 815 is made of a material, such as a plastic material, that can deform radially, and when the rotational force exceeds the predetermined value, such deformation occurs, and the bumps 818 may move over the teeth 814.

Although in the embodiment according to FIGS. 13 to 16, with or without the modifications according to FIGS. 30 and 31, the base film 403 as well as the cover sheet 404 is rolled up, it is not necessary that also a slip clutch or the like. between the ratchet wheel 416 and the base sheet Aufrollrad 470 is provided. The diameter of the base sheet take up wheel 470 is selected to initially roll up the base sheet 403 only loosely, and the tension with which the base sheet 403 is rolled up increases during operation, but never to an unacceptable level. Theoretically, the base film 403 could be precise via a slip clutch or the like. be rolled up while the cover sheet 404 is rolled up only loosely, but it is much easier in practice, the

AT 401 007 Β

Cover film 404 exactly roll because it is flat, and because it is thinner than the base film 403.

The Fig. 17 20 to 20 show schematically the main working parts of a device that has certain similarities with the device according to FIG. 10 has to 12, ie It is a device with a defect. The Fig. 17 to 20 show no complete device for the sake of simplicity, in particular the chamber for the not yet used strip and for the used base film material has been omitted. Components of this embodiment, generally those of FIG. 10 to 12 are denoted by corresponding reference numbers but with the prefix of the number 500 instead of the number 300.

The device according to FIG. 17 to 20 has a pair of wheels 514a, 514b which have intermeshing teeth formed thereon and which act as a flaw that engages the cover sheet material used which is fed into a chamber 513. The wheel 514b is an idler wheel and is urged into engagement with the wheel 514a by a compression spring 595 acting on a bracket 596 supporting the wheel 514b. The wheel 514a has a ring of gear teeth 598 which mesh with teeth 597 formed on a ratchet wheel 516 which performs the same indexing function as the ratchet wheel 16 in the first embodiment and which is rotatable in a chamber 515. The chambers 513, 515 are formed in a housing body 510, and lids 530a, 530b are fixed to opposite sides of the chambers 513, 515. Inhalation is through a mouthpiece 520. The device is actuated by a lever 524, which in turn rotates the ratchet wheel 516 via a pusher arm 526.

In the embodiment of FIG. 21 to 24, another type of mangling device is provided in which both the coversheet and the base film between the wheels undergo deficiency. In the device of FIG. 21 to 24, a housing body 610 is provided which forms a substantially circular chamber 611 and is secured to the lid 612a, 612b. Within the chamber 611, a ratchet wheel 613 and a rolling-up wheel 614 are rotatably mounted for the base film and the cover sheet, the wheels 613, 614 having intermeshing gear teeth. The ratchet wheel 613 has grooves 615, and a cover sheet gripping wheel 618 rotatably supported in a carrier 619 is mounted adjacent to the grooves 615 in the direction of movement after the suction part 616. Behind the suction member 616, a roller 628 is mounted to guide the cover sheet.

A flexible strip 601 is provided as a drug package in the chamber 611, with the majority of the strip 601 initially rolled up along the inner wall of the chamber 611. The front end of the strip 601 extends between guide members 622, 623 and over part of the circumference of the ratchet wheel 613 with its pockets containing powder engaging in the grooves 615. At the point where the strip 601 hits the suction part 616, it is separated, and the cover sheet runs behind the suction part 616 via the roller 628, while the base film extends between the ratchet wheel 613 and the suction part 616. After the suction part 616, both foils pass between the ratchet wheel 613 and the cover film gripping wheel 618, and they are thereby gripped. The front end of the strip is fixed in the base sheet and cover sheet rolling-up wheel 614.

In use, the strip 601 is advanced by rotation of the indexing wheel 613 by means of a lever 624 via a push arm 626 which effects a corresponding rotation of the base sheet and cover sheet take up wheel 614. As a result, the base film and the cover sheet are initially rolled up loosely, with the voltage increasing as the operation proceeds, but without the voltage ever reaching an unacceptable level. The coversheet and base sheet are peeled away from each other where the strip 601 meets the suction member 616, with a fresh bag of powder being presented to the powder outlet 617, respectively. Inhalation takes place via the mouthpiece 620.

The Fig. 32 to 34 show an embodiment in which, as a further special feature, a display with the aid of characters or fonts is provided in order to convey instructions to the user with regard to the subsequent steps or stages which he is to undertake during operation of the apparatus. Apart from these displays, the device essentially corresponds to that shown in FIG. 1 to 3, and corresponding reference numerals are used for corresponding components. However, there are some additional components, as will become apparent from the following description.

The device according to FIG. 32 to 34 has a lid 700 which is pivotally connected to the rest of the device about an axis 701. The gears 23 and 25 and the associated components are covered by a rear wall 702. This back wall 702 extends over the entire back of the device, however, much of the illustration has been broken away in the drawing for ease of understanding except for a small portion thereof. The lever 24 is provided with an arcuate extension 703, wherein at one edge thereof a cam 704 is formed. The extension 703 carries signs or indications in the form of instructions for the user, in this case, for example, the labels OPEN LID, PRESS AND INHOLD BUTTON. When the lever 24 and, accordingly, the extension 703 are in certain positions, one of these labels will be visible through a window 705 in the back wall 702. The distal end of the extension 703 forms a knob 706. That from

AT 401 007 Β the extension 703 remote end of the lever 24 carries a pivotable tongue 704.

Fig. 32 shows the device in its rest position. The inscription OPEN COVER is through the window

705 visible. Now, if a patient opens the lid 700, this brings the device in the in Fig. 33 shown position. The upper rear edge of the lid 700 has hit the cam 704 and moved the extension 703 at an angle such that the inscription PRESS BUTTON through the window 705 has been made visible. Now, when the user depresses the button 706, this causes the lever 24 to rotate, with a container containing a powder, as described in connection with FIGS. 1 to 3 described, is opened. As a result, the device reaches the position shown in FIG. 34 shown position in which the inscription INHALE through the window 705 is visible. In this position according to FIG. 34 the tongue protrudes upward. Accordingly, when the user closes the lid 700 after inhaling, the tongue 707 is struck by a lug 708 on the underside of the lid 700, returning the lever 34 with its extension 703 back into the position shown in FIG. 32 shown rest position, again with the label OPEN LID.

The device just described not only provides step-by-step instructions to the user, reducing the risk of confusion on the part of a patient, but also makes it virtually impossible for the patient to use the device other than as intended because the button 706, FIG. once it has been depressed, is not accessible, until the user again closes the lid 700 and then opens again.

In the embodiments described above, reference was made to a mouthpiece. Of course, however, if the device is intended for purposes other than oral inhalation, a different outlet, such as a nose piece, may be used.