Inhaler for multiple dosed administration of a pharmacological dry powder Number:7,131,441 from the United States Patent and Trademark Office (PTO) owispatent

Title: Inhaler for multiple dosed administration of a pharmacological dry powder

Abstract: An inhaler for multiple dosed administration of a pharmacological dry powder has a housing with a mouthpiece fitted thereon and a removable protective cap that covers the mouthpiece prior to removal. The mouthpiece may be fitted with or without lip grooves, which aid a user in the positioning and manipulation of the inhaler. The inhaler includes a dosing slide, a carriage, a dosing cavity and a valve shield, all of which are arranged within the housing. Removal of the protective cap initiates dosing, which consists of a dose of a pharmacological dry powder being received in the dosing cavity and then transported to the mouthpiece by means of the dosing slide. Only upon application of a defined minimum intensity of inhalation is the shutter moved by the suctioned valve shield, resulting in the release of the dose for inhalation.

Patent Number: 7,131,441 Issued on 11/07/2006 to Keller,   et al.

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Inventors:	Keller; Manfred (Bad Krozingen, DE), Eggimann; Thomas (Pratteln, CH)
Assignee:	SkyePharma AG (Muttenz, CH)
Appl. No.:	09/570,107
Filed:	May 12, 2000

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Related U.S. Patent Documents

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	Application Number	Filing Date	Patent Number	Issue Date
	09077387		6182655
	PCT/CH96/00430	Dec., 1996

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Foreign Application Priority Data

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Dec 07, 1995 [CH]			3463/95
Dec 05, 1996 [DE]			299 08 593 U

Current U.S. Class:	128/203.15 ; 128/200.18; 128/203.23
Current International Class:	A61M 15/00 (20060101)
Field of Search:	128/203.15,203.12,200.22,203.23,206.29,201.26,861,898,200.18 482/13

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Primary Examiner: Dawson; Glenn K.
Assistant Examiner: Erezo; Darwin P
Attorney, Agent or Firm: Mintz Levin Cohn Ferris Glovsky and Popeo, P.C.

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Parent Case Text

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CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation-in-part of U.S. patent application Ser. No. 09/077,387, filed May 28, 1998, now U.S. Pat. No. 6,182,655, which is a 371 of PCT/CH96/00430, filed Dec. 5, 1996.

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Claims

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We claim:

1. A mouthpiece for an inhaler, comprising: a channel inlet; a mouth tube having a channel outlet; and an atomizer path extending within said mouth tube from said channel inlet to said channel outlet, said atomizer path including a first channel section having at least one baffle and a second channel section in communication with said first channel section, said second channel section having a larger volume than said first channel section, said mouth tube including a curved exterior surface having a top side and a bottom side; and a pair of lip grooves that are sized and shaped so as to receive the lips of a patient and that are arranged on said curved exterior surface such that one lip groove is located on said top side and the other lip groove is located opposite said first groove on said bottom side, said mouth tube being comprised of a pair of symmetrical halves, each having corresponding complementary connecting elements and being connected to one another by an integral hinge, one of said symmetrical halves having a first groove segment and a second groove segment, and the other of said symmetrical halves having a third groove segment and a fourth groove segment, said third groove segment cooperating with said first groove segment to form said one lip groove, and said fourth groove segment cooperating with said second groove segment to form said other lip groove.

2. The mouthpiece according to claim 1, wherein said mouthpiece is adapted for use with an inhaler for administration of pharmacological dry powder.

3. The mouthpiece according to claim 1, wherein said first channel section of said atomizer path is formed by walls and said walls form said at least one baffle.

4. The mouthpiece according to claim 3, wherein said first channel section includes a plurality of baffles which protrude into said atomizer path, thereby forming a plurality of curves within said atomizer path.

5. The mouthpiece according to claim 4, further comprising a ramp which is positioned at the channel inlet.

6. A mouthpiece for an inhaler, comprising: a mouth tube having an end face with an upper portion and a channel outlet located in said upper portion of said end face, said mouth tube including a curved exterior surface having a top side and a bottom side; and a pair of lip grooves that are sized and shaped so as to receive the lips of a patient and that are arranged on said curved exterior surface such that one lip groove is located on said top side and the other lip groove is located opposite said first groove on said bottom side; wherein said mouth tube is further comprised of a pair of symmetrical halves, each having corresponding complementary connecting elements, wherein said symmetrical halves of said mouth tube are connected to one another by an integral hinge; and wherein one of said symmetrical halves has a first groove segment and a second groove segment, and the other of said symmetrical halves has a third groove segment and a fourth groove segment, said third groove segment cooperating with said first groove segment to form said one lip groove, and said fourth groove segment cooperating with said second groove segment to form said other lip groove; and an atomizer path extending within said mouth tube from said channel inlet to said channel outlet, said atomizer path including a first channel section and a second channel section, said first channel section having at least one baffle and being in communication with said channel inlet and located at a first level, said second channel section being in communication with said first channel section and said channel outlet; said second channel section including a first portion located at said first level, said first portion communicating with said first channel section and having a larger volume than said first channel section, and a second portion located at a second level which is higher than the first level, said second portion being in communication with said channel outlet of said mouth tube; and said channel outlet including a horizontally oriented slit located in said upper portion of said end face of said mouth tube.

7. The mouthpiece according to claim 6, wherein said mouthpiece is adapted for use with an inhaler for administration of pharmacological dry powder.

8. The mouthpiece according to claim 6, wherein said first channel section of said atomizer path is formed by walls and said walls form said at least one baffle.

9. The mouthpiece according to claim 8, wherein said first channel section includes a plurality of baffles which protrude into said atomizer path, thereby forming a plurality of curves within said atomizer path.

10. The mouthpiece according to claim 9, further comprising a ramp which is positioned at the channel inlet.

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Description

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AREA OF APPLICATION OF THE INVENTION

The invention relates to a dry powder inhaler with dosed administration of a medical preparation upon inhalation by the patient. The dry powder--in loose form or pre-dosed units for dispensing--is contained in a medicament reservoir. The invention concerns the generic type of inhalers in which, upon activation, a defined dose is first of all introduced from the internal medicament reservoir into the inhalation channel by means of a portioning mechanism, and from there the patient draws this defined dose into his airways via a mouthpiece, in a flow of air generated by aspiration. Inhalation is a proven method of depositing medicinal agents in the lungs or delivering them to the blood. Thus, in addition to the devices for atomizing or nebulizing of liquids, for example by means of air, compressors, ultrasound, liquefied propellant gases (fluorohydrocarbons, fluorochlorinated hydrocarbons), inhalers for pulverulent preparations with dosed portioning were also developed for the purpose of inhalation.

A defining feature of inhalers is that the active substance particles of the medicament are deposited, by inhalation, in a defined dose and particle size (about 1 6 .mu.m) either in the central or peripheral lung compartments (topical treatment) or as very small particles by means of absorption in the alveolar region into the blood stream of the patient (systemic treatment).

However, micronized particles with the diameter in question here have extremely poor flow characteristics. This problem is solved by a number of conventional methods. Thus, powder mixtures are produced with a carrier which generally has a greater particle diameter than the active substance, with the active substance particles depositing themselves on the carrier surface. On the other hand, in the manufacture of soft pellets, a large number of active substance particles are massed together to form respectively larger particles, the pellets. Under the effect of force, the pellets split up again into the individual, smaller active substance particles. During inhalation it should be possible with the inhaler to detach the active substance particles from the carrier or to break the pellets up again into small particles. Simple swallowing of the medicament is completely undesirable. For this reason, special functional demands are imposed on inhalers in principle.

PRIOR ART

EP-A-0 404 454 and EP-A-0 558 879 disclose inhalers for single use. Such designs are appropriate only for special applications, since on the one hand the patient has no control over the correct use, i.e. the optimum inhalation, and on the other hand a new inhaler has to be used for each inhalation, which is costly, inconvenient and not environmentally friendly.

Thus, inhalers with a dry powder as medicament were developed also for multiple use. WO 93/03782 discloses an inhaler with a medicament reservoir and a dosing mechanism, by means of which the medicament is conveyed in doses from the storage container into the inhalation channel and can be sucked from there with the flow of air generated by the patient. This inhaler does not yet satisfy all the requirements. The exact and prescribed use can still not necessarily be sufficiently guaranteed. The dosing accuracy has to be increased; humidity too easily penetrates into the inhaler, the deagglomeration and atomization have to be improved, and keeping the inhaler clean is complicated.

U.S. Pat. No. 5,239,992 discloses a further inhaler in which a dosing cavity is present in a longitudinally displaceable piston rod and this dosing cavity, first positioned under the medicament reservoir, receives a dose of medicament. The patient has to inhale counter to the force of a spring, so that the piston rod moves and the ready-to-use dose can be sucked by the patient through suction openings in the guide channel of the piston rod. In principle, this inhaler too exhibits the abovementioned inadequacies.

WO 94/05359 describes an inhaler for multiple dosed administration of a pharmacological dry powder which is contained within a medicament reservoir provided inside the housing. On the inhaler a mouthpiece is joined which is closed outside inhalations by a folding down protective cap. The inhaler further has inside a horizontally movable carriage with a dosing depression. If the protective cap is closed the dosing depression is positioned underneath the funnel-shaped outlet of the medicament reservoir, so that dry powder by its gravity should flow into the dosing depression until it is full if the inhaler is in a vertical position. One filling of the depression represents one dose.

After a preceding inhalation a spring arranged above a bellows is tensed by closing the protective cap. The bellows is placed on the medicament reservoir, an air permeable membrane is provided as a separating wall. During opening the protective cap, the locking of the tensed spring is released, so an air pressure pulse acts upon the medicament reservoir. This air pressure pulse ought to guarantee that in each case the dosing depression is properly filled with dry powder. The carriage is moved by further opening of the protective cap, so the dosing depression is positioned within a suction channel. With the inhalation the medicament dose is sucked out from the dosing depression through the mouthpiece.

The mouthpiece has at one side a flange for joining to the housing of the inhaler and has at the other side a suction pipe outwardly trumped-like opening. A flow channel flows tangentially into the flange which channel is connected with the suction channel, where the medicament dose is available in readiness for inhalation. At the flange, tangentially arranged air openings are provided for the purpose of turbulence of the medicament containing air stream sucked into the mouthpiece.

The spring above the bellows again tenses by closing the protection cap and the carriage goes back into its starting position, so the dosing depression is again positioned underneath the funnel-like outlet of the medicament reservoir and the next inhalation cycle can start.

The previously described inhaler and its pertinent mouthpiece shows the following essential disadvantages: Independent of the intensity of the inhalation, the medicament from the dosing depression can be sucked out too low, such that the medicament particles only insufficiently arrive at their intended position within the patient's respiratory ducts and/or actually only a part of the dose available is sucked out. Thus the patient has no control as to whether the inhalation has been actually done or correctly completed. After opening the protective cap and during inhalation, the inhaler has to be positioned vertically, otherwise the dry powder can flow back from the dosing depression into the medicament reservoir or come into the suction channel situated above the dosing depression and deposit there as a loss. A construction feature is missing which obligates or requires the patient to apply the inhaler in the right functional position, i.e., not in an angled or oblique position in which the medicament does not flow or flows insufficiently into the channel inside the inhaler from which the patient inhales the powder. At least a part of the dry powder of the unused dose can come into the suction channel if the inhalation is incompletely finished or not done at all and the inhaler is not held strictly vertically. By the next inhalation cycle it is metered again, and therefore inaccuracies of the dosage can emerge. Based on the construction, double dosages or dosages under the limit can happen. The extending bellows sucks in a larger amount of external air with each closing of the protective cap, thereby permitting moisture to enter the medicament reservoir. This is disadvantageous for the flowability and the accuracy of metering of the dry powder as known from the literature and the practice. A further construction feature is missing which guarantees that the last 5 to 10 nominal doses in the declared measure (weight and volume) can be delivered in order to solve the tail-off-problem known of inhalers with a multi dosage reservoir. The mouthpiece has at its flange a tangentially discharging channel and openings for acceleration and turbulence of the airstream generated by the patient. This corresponds with the cyclone principle as used for a long time for the dry powder inhalers available on the market (e.g. SPINHALER.RTM., CYCLONHALER.RTM.). The unit for creating turbulence and the mouthpiece can be cleaned and dried internally relatively poor which under certain circumstances can cause microbiological problems.

With further focus on the prior art relevant to inhaler mouthpieces, mouthpieces having circular cross-sections had previously been used in the field, but had the serious disadvantage of potentially reducing the amount of the measured dose of medicament that is to be inhaled by a patient. When extraneous air is permitted into the inhalation channel, the flow of air therein, containing the appropriate measured dose of dry power medicament, is interrupted and the full dose of medicament fails to reach the patient for proper inhalation. Thus, when a patient uses an inhaler, he must snugly encircle the mouthpiece with his lips and insert the inhaler to prevent extraneous air from entering the inhalation channel and ensure proper inhalation of the medicament into the upper respiratory system. In addition, proper rotational orientation of the inhaler and insertion of the mouthpiece a proper distance into the patient's mouth are also important to maintaining the proper flow and delivery of the medicament through the inhalation channel to the patient's mouth.

In order to snugly encircle a mouthpiece having a round cross-section, a patient had to unnaturally constrict or purse his lips, which is difficult and often failed to prevent entry of extraneous air into the inhalation channel, thus, resulting in failure to receive the proper dose of medicament. To address the foregoing problem, mouthpieces with oval shaped cross-sections have been developed to assist the patient in being able to snugly encircle the mouthpiece without undue contortion of the lips at the sides of the mouth. For instance, patent publications EP-B-O 407 028, U.S. Pat. No. 4,227,522 and WO-A-98/30263 disclose inhaler mouthpieces having oval shaped cross-sections.

U.S. Pat. No. 5,622,166, on the other hand, discloses an inhaler mouthpiece that is conically tapered towards the patient's mouth but which does not address the aforedescribed problem.

Patent publications U.S. Pat. No. 5,320,094, WO-A-97/25086, WO-A-98-26827 and WO-A-98/41256 disclose oval inhaler mouthpieces having flat or beveled sections on the top and bottom surfaces of the mouthpieces. While this configuration may assist the patient in snugly encircling the mouthpiece with his lips in an airtight manner, these features do not provide the patient with guidance as to proper rotational orientation of the inhaler, nor how far to insert the mouthpiece into his mouth for optimal positioning during inhalation. Thus, these problems continue to exist in the existing art.

OBJECT OF THE INVENTION

In summary, it may be stated that none of the inhalers known to date can be regarded as optimal. The present invention is therefore based on the problem of producing an inhaler whose functional characteristics are extensively improved. The design construction is intended to conclusively guarantee the prescribed inhalation position and inhalation intensity. In the inhaler there must be a suitable registration and function covering a properly completed inhalation, an omitted inhalation, or an incomplete inhalation; in any event, a multiple dosage is to be prevented. It is necessary to improve the dosing accuracy upon preparation of the individual doses from the medicament reservoir, and the deagglomeration and atomization of the medicament during inhalation. The protection against humidity is to be made more effective and the cleaning of the inhaler should be made easier. It must be ensured that a mouthpiece which has been removed for cleaning is fitted in place again by the patient. The mouthpiece ought to be used as well as in connection with the inhaler to be created as with other inhalers of the present type. It must also be possible for the inhaler to be manufactured efficiently as a mass-produced article and at the same time satisfy all the regulations set forth in drug legislation.

It may, similarly, be stated that the mouthpieces for inhalers for administration of a medicament, especially a pharmacological dry powder, known to date cannot be considered optimal. Thus, the present invention has the object of providing a mouthpiece that facilitates an airtight encircling by the patient's mouth without requiring any special or unnatural efforts to position the patient's lips. At the same time, the mouthpiece has to have a configuration that encourages the patient to hold the inhaler in the proper position of rotation and insert the mouthpiece into his mouth to the optimal depth. Lastly, it should also be possible to dry the cleaned mouthpiece easily, in order to avoid microbiological problems which might otherwise appear.

SUMMARY OF THE INVENTION

The inhaler is used for the multiple dosed administration of a pharmacological dry powder; it consists externally of a housing and of a protective cap which can be removed from a special mouthpiece fitted on the housing. Arranged on the inside there are a slide rail, a dosing slide, a shutter, a carriage, a funnel arrangement, a counter device, a valve shield and a valve guide. Removal of the protective cap initiates the dosing, with the dose received in the dosing cavity being transported to the mouthpiece by means of the dosing slide. Only upon application of a defined minimum intensity of inhalation is the shutter moved by the suctioned valve plate, as a result of which the dose is released for inhalation. Only after a properly completed inhalation can the dosing slide be returned with its dosing cavity under the funnel outlet for the purpose of preparing for renewed filling.

In the inside of the inhaler there are blocking means which come into action as soon as the inhaler, upon removal of the protective cap, is situated in a horizontal and/or axial inclined position going beyond a defined extent. The correct dosing and use position of the inhaler are guaranteed in this way. For the patient's safety, optional blocking means can be fitted which prevent any possibility of the protective cap of the inhaler being closed when the mouthpiece is missing. This ensures that after the mouthpiece has been removed, it is not possible replacing omit to it.

In the mouthpiece, which can be detached from the housing of the rest of the inhaler, there is a labyrinthine atomizing path for powder deagglomeration, in which path there is at least one barrier. For the purpose of reducing the powder flow rate and depositing relatively coarse particles ineffective for inhalation, the atomizing path comprises, upstream of the channel outlet, a channel section which is of increased volume and which deflects the powder aerosol flowing through. The multi-component mouthpiece can preferably be arranged on the inhaler housing by means of a plug connection and can be opened out after detachment from the housing, the mouthpiece parts being connected to one another via an integral film hinge.

In an alternative embodiment of the invention, the mouth tube of the mouthpiece has a pair of lip grooves that complement one another and are situated a predetermined distance from the front end of the mouth tube. When the patient holds the inhaler in the proper rotational orientation, the lips grooves are placed in the region of the patient's upper and lower lip. The configuration of the mouth tube and lip grooves helps the patient achieve an airtight hold on the mouthpiece with his lips so that the suction applied by the patient is completely effective to create an aerodynamically medically efficient flow of the medicament to the patient for effective and full inhalation. Furthermore, the distance of the lip grooves from the front end of the mouth tube is that which will result in the insertion of the mouth tube a sufficient depth into the patient's mouth so as to prevent the undesired deposition of the dry powder medicament in the patient's mouth and throat. The mouthpiece according to the invention is also preferably intended for use with the inhaler according to the invention, but it is also suitable for use in connection with other inhalers of the same type.

In the inhaler there are means which contribute to the regular flow of the pharmacological dry powder when the protective cap is removed. The generated vibrations preferably only exert an effect while the dosing cavity is located under the funnel outlet. These means are advantageously complementary grate sections which are located on components moved relative to one another.

The inhaler can be supplemented with an electronic module and a controllable nozzle so that all data relevant to inhalation can be recorded and the flow conditions regulated. Completion of a correct inhalation, or an incomplete inhalation, can be indicated by an acoustic and/or optical signal.

BRIEF DESCRIPTION OF THE ATTACHED DRAWINGS

For a better understanding of the present invention, reference is made to the following detailed description of several exemplary embodiments considered in considered in conjunction with the accompanying drawings, in which:

FIG. 1A inhaler, side view: closed state (starting position.fwdarw.situation A1);

FIG. 1B inhaler, rear view;

FIG. 1C inhaler, front view;

FIG. 1D inhaler, plan view;

FIG. 1E inhaler: protective cap pulled out (intermediate position.fwdarw.situation A2);

FIG. 1F inhaler, protective cap swung down fully (ready for inhalation.fwdarw.situation A4; inhalation omitted.fwdarw.situation A5; inhalation incomplete.fwdarw.situation A6; inhalation complete.fwdarw.situation A7);

FIG. 2A protective cap, perspective view;

FIG. 2B protective cap, plan view;

FIG. 2C protective cap, side view;

FIG. 2D view into the protective cap;

FIG. 3A lower part of housing, perspective view;

FIG. 3B lower part of housing, plan view;

FIG. 3C lower part of housing, side view;

FIG. 3D lower part of housing, cross-sectional view;

FIG. 3E lower part of housing, perspective view with blocking hooks and balls;

FIG. 3F lower part of housing according to FIG. 3E, plan view;

FIG. 4 upper part of housing, perspective view;

FIG. 5A mouthpiece, perspective view of the base plate;

FIG. 5B mouthpiece, side perspective;

FIG. 5C one half of mouthpiece, external view;

FIG. 5D one half of mouthpiece, internal perspective;

FIG. 5E mouthpiece opened out, internal perspective;

FIG. 6A slide rail, perspective view from below;

FIG. 6B slide rail, side perspective;

FIG. 7A carriage, perspective view from below;

FIG. 7B carriage, perspective view from above, laterally, from the front;

FIG. 7C carriage, perspective view from above, front;

FIG. 7D carriage, perspective view from above, rear;

FIG. 8A dosing slide, perspective view from above;

FIG. 8B dosing slide, perspective view from above, rear;

FIG. 8C dosing slide, perspective view from below;

FIG. 9A shutter, perspective view from above;

FIG. 9B shutter, perspective view from below;

FIG. 10A valve shield, perspective view;

FIG. 10B valve shield, side perspective;

FIG. 11A valve guide, inner perspective;

FIG. 11B valve guide, outer perspective;

FIG. 12A funnel, perspective view from above;

FIG. 12B funnel, perspective view from below;

FIG. 13A funnel holder, perspective view from above;

FIG. 13B funnel holder, side perspective;

FIG. 13C funnel holder, perspective view from below;

FIG. 14A funnel lid, perspective view from above;

FIG. 14B funnel lid, perspective view from below;

FIG. 14C funnel lid with semi-permeable membrane;

FIG. 15A funnel holder, funnel and funnel lid, side perspective;

FIG. 15B funnel holder and fitted funnel, perspective view from above;

FIG. 16A counter, perspective view of the units wheel;

FIG. 16B counter, perspective view of the hundreds wheel;

FIG. 16C counter, units wheel, outer perspective;

FIG. 16D counter, units wheel, inner perspective;

FIG. 16E counter, tens wheel, outer perspective;

FIG. 16F counter, tens wheel, inner perspective;

FIG. 16G counter, hundreds wheel, inner perspective;

FIG. 16H counter, hundreds wheel, outer perspective;

FIG. 16I counter body, inner perspective;

FIG. 16J counter body, outer perspective;

FIG. 16K counter, cover plate, outer perspective;

FIG. 16L counter, cover plate, inner perspective;

FIG. 16M counter, drive wheel, outer perspective;

FIG. 16N counter, drive wheel, inner perspective;

FIG. 16O engagement of the dosing slide on the counter, units wheel;

FIG. 17A blocking hook, plan view;

FIG. 17B blocking hook, perspective view from right;

FIG. 17C blocking hook, perspective view from left;

FIG. 18A inhaler, horizontal longitudinal section according to FIG. 1A on line A--A;

FIG. 18B inhaler, vertical longitudinal section according to FIG. 1D on line B--B;

FIG. 18C inhaler, vertical transverse section according to FIG. 1D on line C--C;

FIGS. 19A to 19D functioning principle of the release of the shutter;

FIG. 19A side wings of the carriage with aperture and cam;

FIG. 19B closed inhaler according to FIGS. 1A and 18A (situation A1);

FIG. 19C shutter close to release, with the protective cap not swung down fully (situation A3);

FIG. 19D shutter released, with protective cap swung down fully in accordance with FIG. 1F (situation A4);

FIGS. 20A to 20F functioning principle of the inhaler

FIG. 20A inhaler closed in accordance with FIGS. 1A, 18A and 19B (starting position.fwdarw.situation A1);

FIG. 20B inhaler open in accordance with FIG. 1F and 19D (ready for inhalation.fwdarw.situation A4);

FIG. 20C closing the inhaler (inhalation omitted.fwdarw.situation A5);

FIG. 20D closing the inhaler (inhalation incomplete.fwdarw.situation A6);

FIG. 20E inhaler closed (after incomplete inhalation.fwdarw.situation A8);

FIG. 20F inhaler closed (after completed inhalation.fwdarw.situation A7);

FIGS. 21A to 21C functioning principle of the blocking hooks

FIG. 21A blocking hooks fitted (starting position.fwdarw.situation B1);

FIG. 21B protective cap blocked when mouthpiece missing (incorrect position.fwdarw.situation B2);

FIG. 21C pivotable protective cap, with mouthpiece fitted (desired position.fwdarw.situation B3);

FIGS. 22A To 22B functioning principle of the blocking of the inhaler at an inclined position

FIG. 22A side position of the blocking balls in incorrect positioning of the inhaler;

FIG. 22B blocked inhaler;

FIGS. 23A To 23G successive construction of inhaler, persective views:

FIG. 23A lower part of housing with valve shield, valve guide and one mouthpiece half;

FIG. 23B representation in accordance with FIG. 23A, with slide rail and carriage added;

FIG. 23C representation in accordance with FIG. 23B, with dosing slide added;

FIG. 23D representation in accordance with FIG. 23C, with shutter added;

FIG. 23E representation in accordance with FIG. 23D, with protective cap added, without lower part of housing;

FIG. 23F representation in accordance with FIG. 23E, with funnel holder, funnel, funnel lid and counter added;

FIG. 23G representation in accordance with FIG. 23F, from the rear side;

FIGS. 24A to 24F alternative embodiment having mouthpiece with lip grooves;

FIG. 24A inhaler of FIG. 1F showing a mouthpiece with grooves;

FIG. 24B perspective view of the mouthpiece of FIG. 24A showing top grooves;

FIG. 24C rear perspective view of mouthpiece of FIG. 24B showing the base plate;

FIG. 24D perspective view of mouthpiece of FIG. 24B rotated 90 degrees clockwise and showing bottom grooves;

FIG. 24E external perspective of mouthpiece of FIG. 24B opened out; and

FIG. 24F internal perspective of mouthpiece of FIG. 24B opened out.

EXEMPLARY EMBODIMENT

In the text which follows, the inhaler according to the invention will be described in greater detail in terms of its construction, as well as its function, with reference to the attached drawings, and possible modifications are mentioned by way of conclusion.

The following statement applies to the whole of the description following. If, for the purpose of clarity of the drawing, reference numbers are included in a figure but are not explained in the directly relevant text of the description, then reference is made to their mention in preceding figure descriptions. In the interest of intelligibility, the repeated designation of components in succeeding figures is for the most part omitted if is it clear from the drawings that the components concerned are "recurring" components.

FIGS. 1A to 1D

Externally, the inhaler according to the invention is made up of lower part 100 of the housing, the upper part 150 of the housing, and the protective cap 950. The lower part 100 of the housing and the upper part 150 of the housing have an elongate, semi-monocoque configuration. The upper part 150 has, on its top side, a fairly large opening 151 for receiving a funnel lid 680, and a window 152 through which the status of the counter can be read off. The lower part 100 of the housing and the upper part 150 of the housing are joined to one another such that a housing is obtained which is in principle closed. Grip contours 951 are provided on the outside of the protective cap 950 to permit better gripping. Grip contours, preferably designed as grip dimples 113, are also arranged on both sides of the housing, in this case extending over the lower part 100 of the housing and the upper part 150 of the housing.

On the top of the protective cap 950, towards the outer edge, there is an elongate recess, by which means a clearance 968 is created together with the adjoining upper part 150 of the housing. By looking into this clearance 968 it is possible to ascertain if the mouthpiece is fitted and the clearance 968 is thus filled, or if the mouthpiece is missing and the clearance 968 is consequently open. Opposite the protective cap 950--on the rear part of the inhaler--the perforated base 854 of the valve guide enclosed by the lower part 100 of the housing and upper part 150 of the housing can be seen.

In the closed state shown here, the starting position--subsequently referred to as Situation A1--the protective cap 950 is fitted flush with the lower part 100 of the housing and the upper part 150 of the housing. Thus, the medical preparation stored in the inhaler is protected quasi hermetically from external humidity.

FIG. 1E

The inhaler has to be opened before use; to do this, the protective cap 950 is first of all pulled out in the axial direction. The line along which the protective cap 950 is pulled out is limited by a pair of side arms 960 which are fixed on the protective cap 950 and engage in a longitudinally displaceable manner in the inside of the inhaler. With the protective cap 950 pulled out this far, the mouthpiece 900 is already partly visible, and is attached to the lower part 100 of the housing and the upper part 150 of the housing at the front and is enclosed on both sides by the side arms 960. As will be explained later, this step is associated with a temporary vibration for exact dosing of the medicament from the powder reservoir. This intermediate position, with the protective cap 950 pulled out, is hereinafter referred to as Situation A2.

FIG. 1F

In order to allow the patient access to the mouthpiece 900, i.e. to permit inhalation, the protective cap 950 suspended on the side arms 960 has to be swung down in a further maneuver. The mouthpiece 900 with the mouth tube 920 protruding from the base plate 910 is now fully visible. The channel outlet 922 through which the patient inhales the medicament is situated on the end face 921 of the mouth tube 920.

In this position, with the protective cap pulled out and swung fully down--subsequently referred to as Situation A4--the inhaler itself is prepared for inhalation. The dose of medicament which has been made ready is in a loosened state. It should be understood that the protective cap 950 can only be swung down when it has first been pulled out to the limit. The dimensioning of the mouthpiece 900, the length of the side arms 960, and the sole possibility of swinging the protective cap 950 downwards, cause the patient by necessity to place the inhaler in the correct position. If the inhaler were used upside down in error, the patient would notice this immediately since his nose would hit against the protective cap 950 and he would thus barely be able to apply the mouthpiece 900.

Situation A3 characterizes the state in which the protective cap 950 is in its swing movement and has not yet reached its lowest position.

FIGS. 2A to 2D

The protective cap 950 consists of the two aforementioned side arms 960 and the actual cap 952. The clearances 968, which provide space for the base plate 910 of the mouthpiece 900, are arranged on that edge of the cap 952 facing towards the mouthpiece 900, centrally on the top side and bottom side.

The two side arms 960 each extend laterally into the cap 952. At the front part, which engages in the inhaler, the side arms 960 have a special construction symmetrical to one another. Each side arm 960 has a square, rounded aperture 961, a pin 962 lying below the rounded aperture 961 and directed inwards, a recess 963 incorporated from the underside of the side arm and having a cut edge 964, as well as forward bevels 969. Between the aperture 961 and the cut edge 964 in each side arm 960 there is a further rectangular aperture 970. Offset above this aperture 970 there is an outwardly directed dimple 971. The same type of dimple 972 is arranged in the lower area of the side arm 960 near the entry to the cap 952.

FIGS. 3A to 3D

The lower part 100 of the housing has, on both sides, a plurality of stop cams 101 spaced apart from one another and projecting above the side wall. To the rear, the lower part 100 of the housing is strengthened at the end, so that a semicircular bearing ring 102 is obtained. A double wall 103, likewise semicircular and with a radial receiving groove 104, is provided on the base at a distance from the bearing ring 102. Running centrally between the double wall 103 is a raised, axial connecting web 115.

Arranged on the base are two parallel bars 106 which extend from the front side 105 and which each have an outwardly facing indentation 116 in the rear area and an obliquely cut aperture 117 in the front area. Together with two columns 118 lying opposite one another at a distance, and a rail 119 extending along the wall of the lower part 100 of the housing, the indentation 116 delimits a depression-like ball socket 108. There is also an indentation 120 provided in the rail 119, and the indentations 116,120 of identical form lie opposite one another. The columns 118 have points 121 which are directed towards one another and which at their deepest point are located in the ball socket 108. On each of the rear columns 118 there is an inwardly pointing hook 122. A raised plug 123 is in each case arranged in front of the front pillars 118, facing towards the front side 105. At the front side 105, two receiving notches 109 are incorporated, as well as two axially extending longitudinal slots 110 in the base--near each housing wall. A safety cam 125 sits to the side at the entrance of each longitudinal slot 110. Between the two bars 106 and the front side 105 there are two U-shaped depressions 124.

FIGS. 3E and 3F

In the completed state, a blocking ball 130 lies in each ball socket 108 and, with the inhaler in the correct position, this blocking ball 130 is located at the deepest point between the points 121 of the columns 118. When the inhaler is in an excessively horizontal or axial inclined position, the blocking balls 130 roll into the indentation 116 of the bar 106 or into the indentation 120 of the rail 119 and effect a blocking of the inhaler, as described in FIGS. 22A and 22B.

To ensure that the removed mouthpiece 900 is put back in place before the inhaler is closed, blocking hooks 140 are optionally fitted on the plugs 123. A blocking hook 140 consists of a spring arm 142 and a lever 143 with a laterally protruding blocking tooth 144 and the catch 145 pointing to the front side 105. The spring arm 142 of a blocking hook 140 passes through the aperture 117, while the lever 143 is pressed outwards by the tensioning of the spring arm 142, so that its blocking tooth 144 protrudes into the course of the longitudinal slot 110 where, in the completed state, the respective side arm 960 of the protective cap 900 sits. The function of the blocking hooks 140 is described in detail in FIGS. 21A to 21C.

FIG. 4

Complementing the stop cams 101, the upper part 150 of the housing has plug holes 153 on its side walls. Analogously to the lower part 100 of the housing, the upper part 150 of the housing also has a semicircular bearing ring 154 to the rear, as well as a double wall 155 with a receiving groove 156. The half bearing rings 102 and 154, respectively, and the receiving grooves 104 and 156 combine to form full circles.

On the side walls, mounted ahead of the receiving groove 156, there are in each case a support cam 158 and a higher overspring rib 157. The support cam 158 and the overspring rib 157 project towards the center of the upper part 150 of the housing and have a common point of origin on the side wall. Adjacent to the window 152, two parallel supports 159 spaced apart from one another are arranged on the interior of the upper part 150. In the interior of the upper part 150 there is also the recess 151 for the funnel which is to be fitted. On both sides of this recess 151, towards the side walls, a limit cam 164 in each case stands out from the interior of the upper part 150.

Corresponding to the longitudinal slots 110 in the lower part 100 of the housing, there are also two slots 161 in the front side 160 of the upper part 150 of the housing. In the front side 160 there is additionally a central receiving notch 162, and two elastic clamping prongs 163 extend from the front side 160 in the direction of the mouthpiece 900. A cross-piece 165 stretches between the front side 160 and the base of the clamping prongs 163, and adjacent to the receiving notch 162. To the rear of the front side 160, the clamping prongs 163 merge into a vertical U-profile 166, the vertical grooves 167 of the U-profiles 166 internally adjoining the front side 160 and facing one another.

FIGS. 5A to 5E

The mouthpiece 900 consisting of the base plate 910 and the mouth tube 920 is advantageously made of two halves which are joined together, for example, by an integral film hinge 923 provided on the end face 921. On the base plate 910, facing the inhaler, there is a full connector plug 911 at the bottom of each half, and a half-cam 912 at the top, which complements the adjacent half-cam 912. Each connector plug 911 has at its front free end, in the lower area, a recess 930 with an inwardly directed bevel 931.

Incorporated underneath the two half-cams 912 is an engagement opening 913 which extends as a shaft 932 right into the mouth tube 920. Deeper in the shaft 932, a recessed groove 933 is present in each case laterally in the wall of the mouth tube 920. The channel inlet 914 for the atomizer path 924 of the mouth tube 920 lies below the engagement opening 913. The channel inlet 914 is connected to the channel outlet 922 via the atomizer path 924. A horizontal ramp 935, complementing the second half of the mouthpiece, is in each case arranged on the base plate 910 under the channel inlet 914.

Inside the atomizer path 924, behind the channel inlet 914, there are a plurality of baffles 925 which protrude into the atomizer path 924 for impacting the medicament-containing air stream and causing it to swirl, so that the atomizer path 924 acquires a course which is rich in curves. Nearer the channel outlet 922, the powder aerosol flowing through enters via an S-curve into an enlarged channel section 928 and is here deflected to the channel outlet 922. The purpose of the special configuration of the atomizer path is to deagglomerate the powder and to reduce the flow rate of the powder so as to deposit coarser particles which are ineffective for inhalation. At the same time, the impacting of particles of active substance in the pharynx of the patient is thus prevented. The mouth tube 920 is flattened off horizontally, at least in the area of the end face 921, so that the patient is induced to employ the correct positioning of the inhaler during use.

FIGS. 6A and 6B

The slide rail 200 has two longitudinal grooves 202 which extend laterally from the end face 201 and parallel to one another, and which reach to approximately halfway along the slide rail 200. In a continuation of the end face 201, two feet 204 spaced apart from one another extend downwards from the bottom of the slide rail 200. At the top, the slide rail 200 has a ledge-like roof part 210 which protrudes over the end face 201 in the manner of a projecting roof. At the opposite end from the end face 201, the