EP0493560A1 - Inhalation device - Google Patents

Inhalation device

Info

Publication number
EP0493560A1
EP0493560A1 EP91912992A EP91912992A EP0493560A1 EP 0493560 A1 EP0493560 A1 EP 0493560A1 EP 91912992 A EP91912992 A EP 91912992A EP 91912992 A EP91912992 A EP 91912992A EP 0493560 A1 EP0493560 A1 EP 0493560A1
Authority
EP
European Patent Office
Prior art keywords
inhalation
ball
mouthpiece
space
nozzle
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP91912992A
Other languages
German (de)
French (fr)
Inventor
Franco Del Bon
Walter Treyer
Original Assignee
Franco Del Bon
TREYER, Walter
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to CH250090 priority Critical
Priority to CH2500/90 priority
Application filed by Franco Del Bon, TREYER, Walter filed Critical Franco Del Bon
Priority to US07/871,979 priority patent/US5355873A/en
Publication of EP0493560A1 publication Critical patent/EP0493560A1/en
Withdrawn legal-status Critical Current

Links

Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B05SPRAYING OR ATOMISING IN GENERAL; APPLYING LIQUIDS OR OTHER FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05BSPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
    • B05B9/00Spraying apparatus for discharge of liquids or other fluent material, without essentially mixing with gas or vapour
    • B05B9/03Spraying apparatus for discharge of liquids or other fluent material, without essentially mixing with gas or vapour characterised by means for supplying liquid or other fluent material
    • B05B9/04Spraying apparatus for discharge of liquids or other fluent material, without essentially mixing with gas or vapour characterised by means for supplying liquid or other fluent material with pressurised or compressible container; with pump
    • B05B9/08Apparatus to be carried on or by a person, e.g. of knapsack type
    • B05B9/085Apparatus to be carried on or by a person, e.g. of knapsack type with a liquid pump
    • B05B9/0877Apparatus to be carried on or by a person, e.g. of knapsack type with a liquid pump the pump being of pressure-accumulation type or being connected to a pressure accumulation chamber
    • B05B9/0883Apparatus to be carried on or by a person, e.g. of knapsack type with a liquid pump the pump being of pressure-accumulation type or being connected to a pressure accumulation chamber having a discharge device fixed to the container
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/0065Inhalators with dosage or measuring devices
    • A61M15/0066Inhalators with dosage or measuring devices with means for varying the dose size
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/009Inhalators using medicine packages with incorporated spraying means, e.g. aerosol cans
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/0091Inhalators mechanically breath-triggered
    • A61M15/0095Preventing manual activation in absence of inhalation
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B05SPRAYING OR ATOMISING IN GENERAL; APPLYING LIQUIDS OR OTHER FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05BSPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
    • B05B11/00Single-unit, i.e. unitary, hand-held apparatus comprising a container and a discharge nozzle attached thereto, in which flow of liquid or other fluent material is produced by the muscular energy of the operator at the moment of use or by an equivalent manipulator independent from the apparatus
    • B05B11/30Single-unit, i.e. unitary, hand-held apparatus comprising a container and a discharge nozzle attached thereto, in which flow of liquid or other fluent material is produced by the muscular energy of the operator at the moment of use or by an equivalent manipulator independent from the apparatus the flow being effected by a pump
    • B05B11/3001Piston pumps
    • B05B11/3016Piston pumps the outlet valve having a valve seat located downstream a movable valve element controlled by a pressure actuated controlling element
    • B05B11/3018Piston pumps the outlet valve having a valve seat located downstream a movable valve element controlled by a pressure actuated controlling element and the controlling element cooperating with means for opening or closing the inlet valve

Abstract

The method described relates to a conditional dosage and spraying of a liquid or pulverulent preparation intended to be inhaled. The condition of the dosage and spraying of the preparation is that the person who inhales must use an inhalation force adapted to its constitution and sufficient for an optimal effect of the inhaled preparation. Without this minimum inhalation force, no dose or spraying of the preparation is possible. The corresponding inhaler comprises a known metering and spraying device (not conditional) and also systems which block by actuation the actuation of the device as long as the minimum inhalation force is not exerted by the person who inhales. . A preferred embodiment comprises, for dosing and spraying, a reservoir with a dosing and spraying pump and, for the mentioned geometric closure, a ball (13) which is movable in a corresponding housing (14). When inhaled, there is produced through the housing (14) an air current which moves the ball (13) from its locked position, position in which it is held by gravity, so that the geometric closure is released and that the pump can be operated manually.

Description

 INHALA IONS DEVICE

The invention is in the field of medical technology and relates to a method and a device for metering and atomizing a preparation for inhalation according to the preamble of independent patent claims 1 and 9, with the aid of which pharmaceutical products such as anti-asthmatics are inhaled in a metered manner can.

Inhalation is a well-known method, for example to bring medication for absorption into the airways and lungs. For this purpose, various inhalation devices are commercially available, with which liquid or powder preparations are brought into the oral cavity in finely divided form. The inhalation devices are designed in such a way that a specific dose of the preparation is dispensed with each application. So that the preparation, which is finely divided by atomization, can get from the oral cavity through the throat into the respiratory tract and into the lungs, it is essential that the patient inhales the atomized preparation into the oral cavity at the same time while using the inhaler . If he does not do this, or does so only to an insufficient extent, the medicament remains in whole or in part in the oral cavity and in the throat and the desired effect is not achieved. Even if the medication is precisely dosed with the inhalation device the effective dose of the medicament depends on the strength of the effective inhalation, that is on the force of the simultaneous inhalation. The part of the dose remaining on the walls of the oral cavity and throat is largely swallowed and remains practically ineffective. If inhalation is weak, the effective dose will be only a fraction of the dose given by the inhaler. Every inhaler knows this lack of the effect of inhalation and is accustomed to achieve the desired effect with a further dose.

Inhalation devices have been developed that only allow dosing and atomization if inhalation is carried out at the same time. Such devices are described, for example, in US Pat. Nos. 3,565,070, 3,789,843, 3,598,294 or in F Pat. No. 70,40542. All of these devices must be brought into an active state using a separate handle before inhalation. In this active state, automatic dosing is triggered by inhalation. In addition to a storage container for the inhalation preparation, all of these devices comprise a complicated mechanism consisting of a lever and spring system and are therefore extensive and, above all, prone to failure.

Such disadvantages do not apply to the inhalation device described in EP Patent Specification 0 147 028, in which the metering is operated manually, but a corresponding locking device ensures that this is only possible when inhalation is carried out. This device also comprises a mechanism consisting of several levers, although less extensive, which is however partially arranged in the area of the spray to be inhaled and is therefore exposed to contamination which jeopardizes its proper functioning.

All existing devices include one for dosing and atomization Storage container which contains the preparation and a propellant gas and is provided with a metering device with which a certain dose of the preparation is atomized per stroke. Different doses for different patients, for example adults and children, are achieved by inhalation of a different number of single doses. As already mentioned, if the device has to be reactivated between the individual doses, the handling appears complicated. The devices are also aimed at the weakest patient, since they are intended to be applicable for patients with different constitutions, that is to say, for example, to children who, according to their smaller lung volume, only a smaller one, but in their case nevertheless for one good effects can generate sufficient inhalation dynamics. In other words, if, for example, an adult uses the same device, he must inhale in order to trigger or unblock the dosage, but not with a strength that is sufficient for optimal inhalation according to his lung volume. All existing devices thus relieve the patient of the synchronization of dosing and inhaling, but only in very few cases compel him to provide an inhalation performance that is adequate for the optimal effect of the preparation.

It is an object of the invention to provide a method for dosing and atomizing inhalation preparations, in which each dose given is also an effective dose by forcing the patient to inhale during dosing, with a strength that is in accordance with his constitution corresponds. With the method according to the invention, the patient should not only be forced to inhale sufficiently, but should also be given the opportunity to train his lung dynamics by inhaling and thereby help him to improve it. In emergencies, however, it should still be possible to dose without or with insufficient inhalation. The preparation should be dosed and atomized according to known methods and prepared by means of an appropriate pretreatment after it emerges from the atomization nozzle in such a way that it contains only particles if possible or contains droplets of a size that is optimal for inhalation and is present in the inhaled air as a stable aerosol if possible.

The inhalation device to be created for carrying out the method should be configurable for different users and adjustable for training the lung dynamics. It should be as small as possible and easy to use. It should include simple mechanical parts that are not susceptible to malfunction and contamination. It should allow the patient to clearly control the delivery of a dose. In the device for atomization and metering, commercially available inhalation preparations or active ingredients should be used in commercially available aerosol cans with a metering valve, but above all also in arrangements with mechanical metering and atomizing pumps that function without propellant gas.

This object is achieved by the method and the device, which are claimed by the characterizing parts of independent claims 1 and 9, respectively.

The method and the device are described in detail with reference to the following figures. Show:

Fig. 1 (a and b) a comparison of the delivered and the effective doses when using a non-inhalation-based and the inhalation-based method according to the invention and a diagram for the training effect of the method according to the invention,

2 (a and b) sections through an exemplary embodiment of the inhalation device according to the invention to illustrate the function, 3 shows a plan view against the nozzle of the embodiment according to FIG. 2,

4 (a to d) a section of a section and a top view corresponding to FIGS. 2 and 3 for two embodiments with adjustable inhalation strength,

5 (a to c) three exemplary embodiments of the mouthpiece of the device according to the invention,

6 (a and b) a further embodiment of the device according to the invention and

7 (a and b) parts to be produced for two exemplary production methods for the device according to the invention.

The invention is based on the fact that sufficient inhalation of the patient is made a condition for the dosage and atomization of the preparation. As long as the patient does not inhale so strongly that the dispensed dose of the atomized preparation can be brought into the patient's respiratory tract with the dynamics generated by inhalation, the metering and atomizing device remains blocked. This avoids unnecessary dispensing of the preparation only into the oral cavity and the walls of the throat, so deliberate or unconscious evasion to avoid the required inhalation performance is not possible. The inhalation strength required to release the device can be adjusted so that the device can be configured accordingly for patients with different lung volumes and thus different possible lung dynamics.

The inventive method of inhalation-related dosing and Through this requirement and a corresponding further measure, atomization also enables training to improve the Lunsjendvnamik. For example, in that the doctor specifically increases the inhalation strength required for a dosage if the patient is able to afford it, the inhaler trains his lungs through the forced inhalation and thereby increases lung dynamics and active lung volume.

The method according to the invention uses (device-related) a jet of very fine particles or droplets produced by a known method, for example pumping through a nozzle or expansion of a propellant gas. The particles or droplets produced with the aid of these processes have different sizes, of which only those with dimensions between 1 and 5 μm are suitable for inhalation. Furthermore, the particles or droplets, especially if they are produced by pumps, have a relative speed with respect to the ambient air and therefore do not constitute an actual aerosol. In a further embodiment, the method according to the invention can now also be followed directly by appropriate treatment of the particle or droplet jet When it emerges from the nozzle, particles that are too large are excreted and the jet and the ambient air are swirled in such a way that a stable aerosol is formed. Such a treatment of the atomized preparation preceding inhalation further reduces the proportion of preparation which only reaches the respiratory tract and remains ineffective.

The device used to carry out the method according to the invention comprises a partial device known per se, with which the preparation to be inhaled is metered and atomized, that is to say a storage container with a manual metering and atomizing pump or a pressure can with a metering valve. In addition, there are parts according to the invention that block the device by positive locking, up to the air flow that flows through the inhalation tion of the patient is generated, the positive connection is released and the device can be operated, and parts according to the invention which serve to pretreat the particle or droplet jet.

Figure la now shows how the inhalation-related method according to the invention differs from a non-inhalation-related method. The inhalation strength S is plotted on the abscissa and the size of the dose D on the ordinate.

The dose aD given by the dosing and atomizing device has a constant size, which depends on the design of the device and which will not be dealt with in more detail here, since the dosing and atomizing of a preparation for inhalation (unconditional) is in accordance with the state of the art corresponds to the technology.

The inhalation strength S is a measure of the suction power that the inhaler provides and on which it depends how much of the dose delivered to her

Destination reached in the respiratory tract or bronchi and the desired one

Has an effect and how much remains in the oral cavity and throat and thus remains practically ineffective.

The curve wD.l shows how the effective dose increases with the inhalation strength until it reaches the dose given with an inhalation strength S1. In other words, if the inhaler exerts suction power S1, provided that all other boundary conditions are optimally met, the entire dose delivered passes through the oral cavity into the breathing system and can become effective. The curve wD.l together with the straight line aD (dashed and solid part) thus represents a non-inhalation conditional dosing and inhalation procedure. The inhaler doses independently of the inhalation strength, but the effective dose is directly dependent on the inhalation strength. If the inhalation performance is insufficient (wDu), then only an insufficient dose of Du results. That part of the dose delivered between the curve wD.1 and the straight line aD is ineffective and lost.

The curve wD.2 together with the extended part of the straight line aD represents the inhalation-related method for dosing and inhalation according to the invention. Dosing is not possible up to the area of an inhalation strength S. 1, at which the entire dose delivered can take effect. With inhalation strengths higher than S.l can be dosed as desired. With this method according to the invention for conditional dosing and atomization, there is no longer any portion of the dose delivered which remains ineffective and is lost; here too, of course, only under the condition that the atomization is optimal, that is to say that the particles or droplets are of a size suitable for inhalation and as stable as possible

Aerosol present.

The strength with which a person has to inhale in order to inhale optimally depends on their constitution and, above all, on the lung volume available and actively used by them, that is to say the inhalation strength S1 varies depending on the patient Place the abscissa S. So that a corresponding inhalation device can be used optimally for different inhalers, it must be possible to configure or set it accordingly.

The active lung volume is approx. 2 to 31t for a child, approx. 4 to 61t for a healthy adult and can be used for an athlete, e.g. Racers climb up to approx. 91 t, but drop to approx. 2 to 31 t for an asthmatics. In any case, the appropriate lung volume can be increased with appropriate breathing training, which is particularly desirable in the case of asthmatics. The adjustability of the inhalation strength that enables the dosage enables such training. The doctor or the inhaler himself can then adjust this inhalation strength in such a way that it always corresponds to the highest performance he has achieved, which he continuously trains by inhaling and thereby increases.

The combination of a manually triggered dosage and an inhalation-related locking of this dosage offers the further advantage that the inhaler is always aware of whether he has inhaled an effective dose or not. Since the delivery of the dose is triggered by a manual action by the inhaler, the inhaler is aware of it, and since each dose delivered is an effective one, this also makes it known in a way. In the case of automatic dosing triggered by inhalation, as described in some ύtr patents mentioned at the beginning, such a simple control is not possible. Even in the case of a non-inhalation-related procedure (ie no performance threshold), the dose is deliberate (manual action), but the size of the effective dose can only be estimated on the basis of undesirable irritation reactions in the throat. Since such stimulus reactions are correspondingly weak in aerosols with very small particles or droplets which are advantageous per se, they are inadmissible as an indication and in order to avoid incorrect doses (delivery of several doses in the case of a weak indication) it may be necessary to use the preparation to be inhaled to add an additional irritant, for example, menthol, as an indicator of the effective dose. Since, according to the conditional method according to the invention, each dose delivered is also an effective one, even the finest aerosols can either be used safely without additional display means and without incorrect doses, or they are nevertheless used to give the patient a kind of feeling of security (Habit) to convey.

FIG. 1b shows schematically the effect of the variability of the inhalation strength required for a dosage. The curve wD \, which allows the delivery of a full effective dose with an inhalation strength S ', is a good setting for an asthmatics who have an active lung volume LV of only 31 t. If the patient increases his active lung volume by inhaling, he can gradually increase the inhalation requirements (arrow) by increasing the necessary inhalation strength S until he reaches a setting wD ", for example, which corresponds to a lung volume of 51 t.

FIG. 2a shows an exemplary embodiment of the device according to the invention, with which a dose of the inhalation preparation can be atomized manually if a specific inhalation rate is achieved at the same time. First of all, briefly those components are used which only serve for metering and atomizing, which in their function can actually be assumed to be known and which in the exemplary embodiment shown are designed as storage containers with atomizing pumps, one embodiment therefore, which has the advantage of a propellant-free function.

The liquid preparation to be inhaled is located in a storage container 1, which has a rigid outer wall 1.1 and a deformable inner wall 1.2, between which there is an air cushion 1.3, and which encloses a front room 1.4. In the storage space 1.4, a suction pipe 2 and a cylinder 3 formed on the suction pipe 2 are arranged in such a way that the free end of the suction pipe 2 is close to the wall part of the storage container 1, which is at the bottom in the normal inhalation position in the direction of gravity. in the Cylinder 3, an inner hollow piston 4 is arranged coaxially in such a way that it can slide on corresponding formations 3.1 of the cylinder in the direction of the common axis and that together with these formations 3.1 it forms an inner, likewise coaxial spring chamber 5, which passes through an axial bore 3.2 is connected to the suction pipe 2 in the bottom of the cylinder 3 and in which a spiral spring 6 is attached. The spring chamber 5 is sealed against the dosing chamber 7 at a balanced pressure. Between the inner wall of the cylinder 3 and the outer wall of the inner piston 4 there remains an approximately hollow cylindrical outer cavity, the dosing space 7. This dosing space 7 is sealed off from the open end of the cylinder 3 by an outer piston 8. which is arranged coaxially with the inner piston 4 and the cylinder 3 and movable in the direction of the common axis. The outer piston 8 has an axial bore 8.1, which connects the metering chamber 7 with the nozzle bore system 9.1 in a nozzle head 9 seated on the outer piston 8. The inner piston 4 has on its side facing the bore S1 an annular sealing surface 4.1 and the outer piston 8 a corresponding sealing edge 8.2. Sealing surface 4.1 and sealing edge 8.2 are pressed against one another in the state of balanced pressure by the spring force of spring 6. The push button 10 with which the metering device is actuated is placed on the nozzle head 9.

If the push button 10 is pressed against the storage container 1, the outer piston 8 and the inner piston 4 are pressed into the cylinder 3 against the suction pipe 2 via the nozzle head 9. This creates a higher overpressure in the metering chamber 7, a less high one in the spring chamber 5 and in the reservoir 1. As a result, the inner piston 4 is pressed against the spring force, so that between the sealing surface 4.1 and the sealing edge 8.2, preparation is pressed into the bore 8.1, and the pushbutton 10 can be pressed further against the supply jar 1. As a result, more preparation is conveyed out of the dosing chamber 7 against the nozzle and the air cushion 1.3 is compressed more. Is the Push button 10 fully pressed, the pressure in the dosing chamber 7 drops and the sealing surface 4.1 is pressed onto the sealing edge 8.2 again. If the push button is now released, the spring 6 presses the inner and outer pistons (4 and 8) and thus the nozzle head 9 and the push button 10 into their starting position. This creates a negative pressure in the metering chamber 7, through which the preparation between the inner piston 4 and the molding 3.1 is sucked out of the spring chamber 5. The pressure equalization in the storage container occurs through a vent valve (not shown) that opens between the two walls 1.1 and 1.2. As a result, the device is again in the same position as before the dosing, the storage space 1.4 has decreased by one dose, the space between the walls 1.1 and 1.2 has increased by one dose.

The nozzle head 9 carries a laterally arranged nozzle 9.2, through which the pumped-out dose is atomized, and is accommodated in a housing 11, which is firmly connected to the supply jar 1 and carries the mouthpiece 12 on the nozzle side. The pushbutton 10 protrudes from the housing 11 through a corresponding opening. If the pushbutton 10 is actuated, the nozzle head 9 moves relative to the housing 11 and mouthpiece 12. Such a relative movement can, however, be prevented by a ball 13 which is loose is mounted in a spherical space 14 which extends over the separating surface between the housing 11 and the nozzle head 9. If the ball 13 is in the position shown in FIG. 2a, that is to say in such a way that the said separating surface runs through the ball, it brings about a positive fit between the housing 11 and the nozzle head 9. The ball chamber 14, when the inhalation device is held in the inhalation position (storage container 1 below, push button 10 above), is inclined against the force of gravity, so that the ball 13 is driven into the positive-locking position by the force of gravity. The ball chamber 14 is designed in such a way that air can circulate around the ball and that the ball 13 can move freely therein up to a stop 12.1. the actual sphere 14 from its mouth into the interior of the mouthpiece 12 separates and prevents the ball 13 from leaving the ball chamber 14. The ball chamber 14 is open on the one hand to the interior of the mouthpiece 12 and on the other hand to the outside through an air duct 15 between the nozzle head 9 and the housing 11 and through an air hole 11.1 in the housing 11. The ball 13 lies in its form-fitting position on the mouth of the air duct 15 in the ball chamber 14.

Only when the ball 13 is moved against the stop 12.1 in the ball chamber 14, to such an extent that it no longer lies in the part of the ball chamber 14 which is recessed in the nozzle head 9, is there a relative movement between the housing 11 and the nozzle head 9, that is to say one Dosage and atomization of preparation possible.

For inhalation, the device is brought into the inhalation position (storage container 1 at the bottom, push button 10 at the top), the opening of the mouthpiece 12 is taken between the lips and pressure is applied to the push button 10 with a finger. If the inhaler now breathes in, an oppression arises in the interior of the mouthpiece 12. The ball 13 is thereby lifted from the mouth of the air channel 15 and air flows through the air hole 11.1 and the air channel 15 (arrows LS) into the ball chamber 14 and the interior of the mouthpiece 12. If this air flow is strong enough, it moves the ball 13 against the stop 12.1 and thereby the positive connection is released. The force exerted on the push button 10 can now press it against the housing, as a result of which a dose of preparation is atomized.

For an emergency in which the patient needs a dose of the inhalant for some reason without being able to inhale sufficiently, he can simply use the device "upside down", ie with the supply jar 1 at the top and the push button 10 at the bottom. In this position, the ball 13 can Do not block the device, as it is driven against the stop 12.1 by gravity.

Figure 2b shows the same inhalation device as Figure 2a but the push button 10 is in its depressed position. The ball 13 is against the stop 12.1, the two parts of the ball chamber 14 are shifted against each other, since the nozzle head 9 has shifted relative to the housing 11. As soon as the air flow LS and the pressure on the pushbutton 10 decrease, the nozzle head 9 moves back into its starting position in the housing 11 and the ball 13 falls back into the positive-locking position, driven by gravity.

FIG. 3 shows a section of a view of the inhalation device according to FIGS. 2a and 2b as a top view against the opening of the mouthpiece 12. Then the mouthpiece 12 can be seen and through its opening the nozzle head 9 with the nozzle 9.2. Under the nozzle 9.2, the mouth of the ball space 14 into the interior of the mouthpiece 12 can be seen and the ball 13, which is actually not visible, is indicated in its form-fitting position. The air hole 11.1 is located under the ball 13.

The inhalation device shown in FIGS. 2 and 3 comprises, as a means for positive locking between the nozzle head and the housing, a ball which is moved in a corresponding opening. This ball represents a simple form-locking means. It is arranged outside the area of the atomized preparation and is therefore not exposed to any contamination which would impair its function. The handling is very simple. The device only needs to be brought into the inhalation position (supply jug 1 below, push button 10 above) and the ball is in the positive-locking position. It automatically returns to this position after inhaling. There is therefore no need for a special handle to activate the device It is advantageous in cases where several doses are to be inhaled. The device can be configured for different users, for example, by inserting balls of different sizes or weights.

Of course, the means for positive locking can also be designed differently. According to the task for the device according to the invention, the form-locking means must meet the following requirements:

- The positive connection must be effected between two parts that move relative to one another when the metering and atomizing mechanism is actuated.

The form-locking means must be simple and arranged in such a way that they are not contaminated by the atomized preparation.

The positive connection must be able to be released by the dynamics caused by the inhalation, and the minimum dynamics required for the solution must be adjustable.

As soon as this dynamic no longer has an effect, the positive locking must be automatically created again.

Correspondingly designed springs or lamellae are also conceivable as form-locking means.

The exemplary embodiment of the inhalation device according to the invention described in connection with FIGS. 2 and 3 comprises, for metering and atomizing the preparation, a push-button actuated pump. Other known devices can also be used, such as pumps of a different type or pressure cans filled with a propellant gas with a metering valve.

The exemplary embodiment of the inhalation device according to the invention described in connection with FIGS. 2 and 3 does not include any means with which the inhalation strength necessary for a dosage could be set. This minimum inhalation strength, which is necessary due to the design of the device and is necessary for releasing the dosage, is determined above all by the size and weight of the ball 13 and by the smallest opening cross section between the air hole 11.1 and the mouth of the ball chamber 14 into the interior of the mouthpiece 12, that acts as a throttle. The heavier and smaller the ball 13 and the smaller this smallest opening cross section, the higher the inhalation strength required for a solution of the positive connection. For example, balls of different sizes or weights can be used to configure the device for different users. Furthermore, means for throttling the air flow LS can be provided, for example, the basic setting of which determines the configuration of the device and which can still be fine-tuned by the doctor or the user for training purposes. Two exemplary embodiments of such throttling means are shown in FIGS. 4a to 4d. In both cases, an adjustable throttle in the form of a slide is attached to the air hole 11.1.

FIGS. 4a and b show a detail in section like FIG. 2a and in a top view like FIG. 3 the spherical space 14 with the spherical 13 in the form-fitting position, the air duct 15 and the vent 11.1. The air hole 11.1 is designed as a triangle and carries a rotary slide 40, which can be rotated between the positions 40.1 and 40.2 and which is shown in FIG. 4b in the position (40.1) in which those for a release of the positive connection - the necessary inhalation strength corresponds to a minimum. By turning the rotary valve 40 in the direction of the arrow, the necessary inhalation strength increases. The two extreme positions 40.1 and 40.2 of the rotary valve can be varied by the manufacturer in terms of a configuration of the device by positioning the corresponding stops.

FIGS. 4c and d show sections corresponding to FIGS. 4a and b, but in this exemplary embodiment a simple slide 41 is provided for throttling the air flow, which more or less cuts the air hole 11.1 (here with a round opening cross section) depending on the setting 'eating and acts as a throttle. A movement of the slide 41 in the direction of the arrow causes an increase in the inhalation strength necessary for the release of the positive connection.

The method according to the invention can provide treatment for the atomized preparation in which droplets or particles which are too large for inhalation are excreted and an aerosol is created by swirling which is as stable as possible. To carry out this treatment, the interior of the mouthpiece must be designed accordingly. In this interior, the atomized preparation is passed from the nozzle 9.1 into the mouth of the inhaler. It proves to be advantageous to design this interior in such a way that the atomized preparation is deflected and guided past baffles. The optimal treatment of the atomized preparation is strongly dependent on the type of preparation, on the pressure and speed conditions resulting from the atomization and on the size of the dose. Appropriate means (appropriately shaped mouthpiece, baffles, impact surfaces, absorption surfaces etc.) must be tested empirically and used accordingly. FIGS. 5a to c show various exemplary embodiments of mouthpieces in which deflection and swirling are forced by appropriate mechanical means. The upper part of the inhalation device is shown in section and the part of the mouthpiece that supports the opening is shown in a top view.

The embodiment shown in FIG. 5a has a mouthpiece 12a, the round opening 51a of which is in the inhalation position at the top. The atomized preparation bounces off the wall opposite the nozzle 9.2 and is deflected by approximately 90 °. The impact surface can be bare or coated with an absorbent. The droplets or particles of the atomized preparation are deflected on a bare baffle without losing much speed, while an absorbent brakes the droplets or particles and absorbs them too large. Corresponding absorbents can consist, for example, of sintered material, cellulose or gauze.

The embodiment shown in FIG. 5b has a mouthpiece 12b, the slot-shaped opening 51b of which is also attached at the top. The advantage of a slit-shaped opening arranged in this way is that the atomized preparation is grasped close to the impact surface. The impact surface is covered with an absorber 52.1 and further comprises an absorbent 52.2, which absorbs the droplets of preparation remaining in the interior of the mouthpiece.

The embodiment shown in FIG. 5c has a mouthpiece 12c, the opening 51c of which is designed as a wide slot is made in the wall opposite the nozzle 9.2. In this case, however, the opening 51c and the nozzle 9.2 are offset in height, so that at least a part of the atomized preparation bounces off and is deflected against an absorber roller 53 attached under the opening 51c. In such a mouthpiece interior the preparation is also swirled.

All of the exemplary embodiments of the device according to the invention described so far have a nozzle oriented horizontally in the inhalation position and a correspondingly angled nozzle bore system. Of course, embodiments are also conceivable in which the nozzle is a different one, for example a vertical one. Direction. Figure 6 shows such an exemplary embodiment. The nozzle 9.2 and mouthpiece 12d are directed vertically upwards (inhalation device in the inhalation position). The actuation function takes place via a pushbutton 61 attached to the side of the housing 11d. FIG. 6a shows the inhalation device (partially cut) in the blocked position, that is to say with the ball 13 in the positive-locking position, FIG. 6b in the active position, that is to say with the button 61 and the ball 13 moves out of the positive position. It should be noted that in this embodiment, by pressing the pushbutton 61, the housing ldd and the mouthpiece 12d are moved with the nozzle head 9d relative to the supply jumper Id.

Two exemplary methods are proposed for producing the embodiment variants of the inhalation device according to the invention shown in FIGS. 2 and 3. FIGS. 7a and b show the parts which are to be produced specifically for the two production methods and which in both cases comprise the housing 11, the mouthpiece 12 and the ball 13 (not shown). In addition, a known device for metering and atomizing an inhalation preparation is required. If the indentation in the nozzle head 9, which forms part of the spherical space 14, cannot be attached to the commercially available nozzle head, the outer piston 8 must be lengthened so that a locking part 9 ″ between the nozzle head part 9 ′ belonging to the commercially available device and the storage container 1. of the nozzle head can be attached. FIG. 7a shows a housing l le consisting of one part and a similar mouthpiece 12e. It should be noted that the stop 12.1 is formed on the mouthpiece. For assembly, the housing is placed over the metering device without a pushbutton. A comb 71 on the housing l snaps into a corresponding groove on the storage vessel. In order to enable assembly with precise positioning of the two parts of the spherical space, the opening of the housing is provided with a positioning cam 73 which fits into a corresponding groove on the neck of the push button. After the housing has been installed, the pushbutton is attached to its neck. Then the ball is inserted into the parts of the ball chamber 14 embedded in the housing l and nozzle head and finally the mouthpiece 12e is placed, which for this purpose is provided, for example, with pins 73 which fit into corresponding holes on the housing. The two parts can also be welded. The advantage of a reversible connection between the housing and the mouthpiece is that the device can be reconfigured even after completion by inserting another ball.

FIG. 7b shows the one of two parts which are mirror images of one another and which have to be produced for the second exemplary production method. This part comprises one half of the housing 11f and one half of the mouthpiece 12f, the planes of symmetry representing the dividing line between the two corresponding halves. For the assembly of the inhalation device, a known metering and atomizing device with a push-button attached is placed in the part shown in such a way that the comb 71 engages in the corresponding groove on the storage vessel and the positioning cam 73 lies in the corresponding groove on the neck of the push-button . Then the ball is inserted into the (half) ball chamber 14 and the second part, which is the mirror image of the part shown, is opened via the metering device and the ball inserted the part shown, for which purpose, for example, pins, on the other corresponding holes or similar fasteners are provided. The two parts can also be welded. This manufacturing variant is particularly advantageous if adjustable throttling means and / or more complex blocking means are to be installed as balls.

Claims

P A T E N T A N S P R Ü C H E
A method for dosing and atomizing a liquid or powdered preparation for inhalation, characterized in that dosing and atomization can only be activated if the inhaler has a certain inhalation performance adapted to the constitution of the inhaler and sufficient for a good effect of the preparation provided, and are blocked when the inhalation is below this certain value.
Method according to claim 1, characterized in that a form fit is used for blocking the metering and atomization, which is released from the dynamics generated by the inhalation and, as soon as this dynamics ceases, is automatically restored.
15
A method according to claim 2, characterized in that gravity is used for the restoration of the positive connection.
20th
Method according to one of claims 1 to 3, characterized gekennzeich¬ net that the inhalation strength necessary for releasing the dosage and atomization of the preparation is adjustable.
25
A method according to claim 4, characterized in that the adjustability of a part as a fixed preset for configuring the Device for different users, on the other hand is used as a readjustment for training the user.
Method according to one of claims 1 to 5, characterized in that the atomized preparation is deflected and / or swirled.
Method according to one of claims 1 to 6, characterized in that particles or droplets of the atomized preparation which are too large for inhalation are absorbed.
Method according to one of claims 1 to 7, characterized in that there is the possibility of an emergency activation for emergencies for which no inhalation work has to be performed.
9. Device for metering and atomizing a liquid or powdery inhalation preparation, characterized in that it comprises movable form-locking means, which are attached between parts that move relative to one another when actuated, and that it comprises an air duct system that runs in the area of the form-locking means and is arranged in the device such that an air flow is generated therein by inhalation.
10. The device according to one of claim 9, characterized in that the positive locking means consist of a ball (13) and a ball space (14), that the ball (13) is loosely mounted in the ball space (14), that the ball space (14) two in operation Parts of the device which move relative to one another extends in such a way that the spherical space (14) on the one hand has an opening into the inner space of the mouthpiece (12) and on the other hand has an opening to the outside in such a way that the spherical space (14) is designed such that the ball (13) can assume a position (form-fitting position) 5 in which it is cut by the separating surface of the device parts forming the spherical space (14) and at least one further position in which the said separating surface does not run through the ball (13), and that the spherical space (14) is inclined in the direction of gravity such that the form-fitting position of the spherical (13) 10 lies first in the spherical space (14) when the device is in the inhalation position.
11. The device according to claim 9, characterized in that the 15th
Form-locking means comprise a spring.
12. Device according to one of claims 9 to 11, characterized gekenn¬ characterized in that an adjustable 20 throttle is installed in said air duct system.
13. The apparatus according to claim 12, characterized in that the adjustable throttle consists of a rotary valve or a slide 25 which is arranged on the air hole (1 .1).
14, Device according to one of claims 9 to 13, characterized in that the opening of the mouthpiece (12) is on the extension of the nozzle axis or on top (when the device is in the inhalation position) on the mouthpiece (12). . 15. Device according to one of claims 9 to 14, characterized gekenn¬ characterized in that the opening of the mouthpiece (12) is round or slot-shaped. 5
16. The device according to one of claims 9 to 15, characterized gekenn¬ characterized in that the mouthpiece (12) contains absorbent (52.1, 53) and / or absorbent (52.2). 10
17. The apparatus according to claim 16, characterized in that the
Absorbents are flat and attached to the baffle surface at the nozzle height (52.1) or roll-shaped and are attached eccentrically to the nozzle in front of the baffle surface.
18. Device according to one of claims 9 to 12, characterized gekenn¬ characterized in that the channel system (9.1) in the nozzle head (9) is straight 20 or angled.
EP91912992A 1990-07-27 1991-07-26 Inhalation device Withdrawn EP0493560A1 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
CH250090 1990-07-27
CH2500/90 1990-07-27
US07/871,979 US5355873A (en) 1990-07-27 1992-04-22 An inhalation device and method having a variably restrictable air inlet that allows the inhalation force required to overcome a locking element to be changed

Publications (1)

Publication Number Publication Date
EP0493560A1 true EP0493560A1 (en) 1992-07-08

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Application Number Title Priority Date Filing Date
EP91912992A Withdrawn EP0493560A1 (en) 1990-07-27 1991-07-26 Inhalation device

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US (1) US5355873A (en)
EP (1) EP0493560A1 (en)
AU (1) AU641268B2 (en)
CA (1) CA2069753A1 (en)
WO (1) WO1992002268A1 (en)

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AU8220991A (en) 1992-03-02
WO1992002268A1 (en) 1992-02-20
US5355873A (en) 1994-10-18
AU641268B2 (en) 1993-09-16
CA2069753A1 (en) 1992-01-28

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