DD145887A5 - INHALATIONSGERAET - Google Patents

Abstract

The invention relates to an inhalation device used in connection with conventional aerosol delivery devices, which is used to treat diseases of the respiratory tract. The object and the object is to provide an easy-to-handle inhalation device with which the administration of a medicament in aerosol form during normal breathing is possible. without coordination of respiration and aerosol release by the patient being required. The device includes a chamber whose volume is smaller than the tidal volume. It has an inlet and a lip. The device is provided with a holder for fixing the position of the aerosol dispenser with respect to the chamber. The chamber has on its outlet side a mouthpiece which also the inhalation opening has a Luftauslaszstutzen. At Auslasz between the chamber and Mundstueck a first valve is attached, which opens when inhaled and closes on exhalation. A second valve is connected to the Luftauslaszstutzen the Mundstueckes. It closes when inhaled and opens when exhaling.

Description

i Berlin, 15. 1 »1980 GZ 56 045 16

Inhalationscjerät

At weη you ng s gebie e rf t in dun α,

The invention relates to a device for the inhalation of medicaments for the relief of diseases of the reproductive tract. The device is used in conjunction with conventional aerosol dispensing devices.

For some time, various drugs have been available in aerosol dispensers. These devices are provided with simple mouth tubes, where the delivery of the aerosol from the reservoir and the inhalation must occur simultaneously. "The usual mouth tubes have significant drawbacks * First, there is an undesirable deposition of significant amounts of the drug in the neck of the patient Secondly, a patient must coordinate inhalation and release of the aerosol to get the drug into the airflow at the right time. It is therefore difficult to ensure that a suitable dose of the drug reaches the desired site of action. " On the other hand, because of the side effects, a precautionary dose increase per stroke of the delivery device may be of concern. "The necessary coordination is an important factor, especially in children, because they often have the necessary manual skills or ability to coordinate successfully used LEVERAGING the usual appliances only such patients _for the over eino good manual dexterity and coordination skills have * This is the treatment of patent

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- 2 - £ were too much left to chance

The aim of the invention is to have available an inhalation device which is easy to handle by all affected patients, including children, and with the aid of which a suitable dose of the medicament enters the respiratory stream at the right time and thus directly to the site of action.

the essence of the invention

The invention has for its object to provide a device for use in conjunction with metered dose dispensers, with which the application of a drug in aerosol form during normal breathing is possible without a coordination of respiration and aerosol release by the patient is required

The inhalation device according to the invention comprises a chamber whose volume is "substantially smaller than the normal tidal volume". It has an inlet and an outlet. * The chamber establishes the path of the respiratory flow during inhalation between the inlet and the outlet provided with a support which fixes the aerosol delivery device with respect to its position to the chamber and allows the delivery of the aerosol into the chamber. At the side of the outlet, the chamber is connected to a mouthpiece which has an air outlet port in addition to the inhalation port The chamber and the mouthpiece are fitted with a first valve which automatically opens when inhaled through the device and closes automatically when exhaled »

15 · 1 * 1980 GZ 56 045 16

15

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A second valve is connected to the mouthpiece air outlet port in such a way that it automatically closes when breathed in by the device and automatically opens upon exhalation. "This valve system allows the application of an aerosolized medicament during normal breathing through the mouthpiece."

In one embodiment of the inhalation device according to the invention, the mouthpiece instead of the air outlet with valve on small openings which allow the passage of air in both directions, but are dimensioned such that when inhaled through the mouthpiece, the majority of the breathing air through the chamber and the valve to its outlet into the patient's mouth »

It is also possible to replace the holder for the aerosol delivery device with an adapter _for holding the machine on a usual mouthpiece for Aerosolabgabegoräte by plugging be fixed "

Furthermore, it may be appropriate to make the inhalation device according to the invention telescopic,

The invention will be explained in more detail below with reference to exemplary embodiments "in the accompanying drawings;

Fig * It is a perspective Schnitt.durch a preferred embodiment of the device according to the invention, in which the aerosol dispenser is partially inserted,

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Fig »2ϊ a simplified longitudinal section dee device at oor exhalation

3 shows a longitudinal section corresponding to FIG. 2 during inhalation, FIG.

4 shows the longitudinal section of another embodiment of the device according to the invention,

5 shows the longitudinal section of a further embodiment of the device according to the invention.

Fig. 1 illustrates a device 20 comprising the chamber 22, a mouthpiece 24 connected thereto, through which the medicament released from the delivery device 26 is inhaled, and a support 28 which fixes the delivery device in its position to the chamber 22 Valve 30 allows inhalation through the chamber 22 to the mouthpiece 24 while preventing exhalation through the mouthpiece 24 into the chamber 22. A second valve 32 permits exhalation through the device, but prevents inhalation through the air outlet port The chamber 22 consists of a cylindrical wall 36 and comprises an end portion 38 to which the bracket 28 for the aerosol dispenser is attached "with the bracket 28 fixing the position of the dispenser relative to the chamber 22." Through the end wall 41 is a cylindrical part 40 connected to the wall 36 aer chamber. the cylindrical part 40 forms the extension of the mouthpiece 24, the outer end 42 one for use by the patient _(e corresponding to FIG 2 and 3) appropriate shape * The mouthpiece 24 also includes a röhrenför-

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small air outlet 34 with the valve 32 "The valves and 32 have similar shape and each consist of an outer frame 44; 46 with webs and a central pin 52; 54, where the thin _t elastic valve discs 48; In order to simplify the manufacture of the device, the finished valves are expediently inserted into the housing and possibly fastened. From the arrangement of the valves, the air flow must reach the mouthpiece 24 during inhalation through the chamber, while he takes the path through the outlet 34 when exhaling "The bracket 28 is designed so that it receives a substantial part of the aerosol dispenser and held by friction in the desired position to the chamber 22" The bracket 28 consists essentially of a cylindrical Haupttoil 56, The cylindrical body 56 has an outer edge 58 with inlet ports 60 and a central fastener 62 supported by 3 webs 64 extending from the inside of the main body 56 58 is shaped so that it comprises the part 38 OQR chamber 22 tightly The fixing of the Rando 58 to the chamber 22 can be done mechanically, so that the holder can be separated if required from aer chamber 22 28 "However, both parts can also, for" B "by gluing, to be inextricably linked, Oedoch is a to prefer detachable plug connection.

The fastening element 62 in the middle of the holder 28 has a larger opening 66, into which the valve stem 68 of the dispensing device 26 provided with an axial outlet opening is inserted and held by friction * The opening 66 terminates in a narrower opening 70,

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through which the aerosol can be sprayed into the chamber 22 _e

Figs. 2 and 3 show the device 20 in use. In Fig. 2 it can be seen how a patient 72 exhales through the mouthpiece 24 and its associated outlet port. The valve 32 has automatically opened while the pressure generated by the exhalation holds the valve 30 in the closed position "With the present device" it is possible to deliver a defined dose from the dispenser 26 into the chamber 22. This is done in the US Pat In this way, the outer end of the dispensing device 26 is printed inward, thereby actuating the conventional metering valve in it A dose of medicament then passes into the chamber 22 as an aerosol and is available to the patient for inhalation it is also possible for the patient to breathe normally through the device and actuate the delivery device during exhalation, as shown in Fig. 2. However, it is also possible to spray the medication dose into the chamber 22 shortly before the patient starts the device Thus, patients with reduced skill can manipulate the delivery device by placing the device with the outer end of the dec abegerätes against a suitable object, ζ * B, against a table press "Thus, a dose is delivered into the chamber 22 'and aer user can then set the device to the mouth as he breathes normally. At the next inhalation, the valves move to the position shown in Fig _e 3; Valve 32 is closed, valve 30 is opened. Accordingly, when inhaled through the inlet ports GO of the holder 28 ₄ , the breathing air flows through the chamber and the mouthpiece into the respiratory tract of the patient

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Patients and transports the drug into the lungs. However, if the administration of the medicine was highlighted by normal breathing by the device, so it is of course also possible to dispose the device according dor inhalation and normal exhale "

The apparatus 20 is of simple construction and therefore inexpensive to produce, although usable for multiple dispensers, it can also be used as a disposable appliance and can be discarded with the empty dispenser at any one time.

It has been found that by spraying and then inhaling the drug dose into the chamber, the ratio of desired effect and undesirable side effects to direct inhalation from conventional aerosol dispensers is significantly improved. "

In the direct inhalation about 7.2% of the delivered dose pass into the lungs, while depositing more than 50% in the neck "These figures are for a normal patient, Irn case of asthma Nati duck was found that the proportion of the dose of Lungon the reached, is reduced to about 6.2 % and retained in the neck over 50 % . In contrast, when using the device according to the invention, about 6.6 % of the dose reaches the lungs of a normal patient, while about 3 % is retained in the neck. In patients with obstructive pulmonary disease, the proportion of the dose reaching the lungs only increases 6.2 % reduced, and in the neck about 3.5 % retained. It turns out, then, that the remarkable reduction in deposition in the throat does not result in a substantial reduction

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the dose proportion which reaches the lungs is paid for. The advantage which the use of the device according to the invention entails is therefore significant. The unexpected benefits may be due to the fact that the coarser particles releasing the dispenser are retained on the walls and through the valve. With some drugs liquid carriers are used and sprayed therefore small droplets "A portion of this reflected to the Y / andungen down the chamber, while other dry, wherein very fine particles remain entrained by the breathing air through the neck and trachea and Reach lung,

The dimensions of the chamber and its location relative to the delivery device also have an effect on the outcome for a given delivery device. If the chamber is too small, an undesirably high proportion of the dose is retained, while if the chamber is too large, undesirably large particles enter the respiratory flow can"

As an example of a suitable embodiment, the apparatus according to Fig. 1 is to be evaluated. With a dispenser using 20 % Freon 12 and 80 % Freon 114 as the propellant, it has been found that the clear length of the chamber 22 is between about 8 and 10 cm, the clear diameter should be between about 3 and 4 cm *

As the above statements show apparatus of the invention is easy to manufacture, inexpensive and easy to handle even by those people who have difficulty with the coordination of breathing and aerosol release. It has also been shown that the size of particles entrained by the respiratory air is reduced in the favorable size

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rich from 1 to 5, to lie. This ιeilchengröße is optimal and has the consequence that the unwanted deposition in the throat, compared with devices of the prior art, is decisively reduced »The device of the invention can therefore be used by a very large proportion of patients, including children and persons with insufficient skill.

It will be apparent that the apparatus as described above may be varied in many ways within the scope of the inventive concept. "For example, it may be preferable to place the dispenser vertically rather than horizontally and otherwise make the valve system" Now referring to Fig. 4, as can be seen in Fig. 4, there is provided a device 74 having a chamber 76, a mouthpiece 78 and a support 80. These parts functionally correspond to those denoted in Fig. ₁ Also, a valve 81 similar to the valve 30 is provided, but instead of the air outlet nozzle and valve 32 of Fig. 1, a number of smaller apertures 82 are provided to form the air outlet in the wall of the mouthpiece. During inhalation The air flow is predominantly through the inlet openings 84 in a closure head 86 of the chamber 76 and then through the vent l _81? because the resistance in this way is much lower than the Ausloßöffnungen 82. A certain part of the air we breathe but also sucked through the openings 82 in the mouthpiece and dried as previously mentioned, the drug addition "The exhalation is done by Outlet Orifices 82 * This embodiment uses only one valve and may be preferable in some cases.

15,! ♦ 1980 GZ 56 045 16

In another embodiment, the device according to the invention is designed so that it can be plugged onto conventional mouth tubes for aerosol dispensers. A device 87 of this type is shown in Fig Oedoch v / eist 3s "displayed 5, which shows a longitudinal section * In principle, this device 4 is similar to that of FIG," instead aer holder for the dispenser adapter 88, with which it known to the The other parts correspond to Fig. 4 "There is provided a mouthpiece 78 in which outlet ports 82 for exhalation and a valve 81 for inhalation are attached _e

To reduce the dimensions of the erf indungsgernaßen device, for example the embodiment of FIG. 1 or FIG _e 5, it may be advantageous also be designed telescopically "

Claims (4)

15. 1. 1900 GZ 56 045 16 Erf indunqeansp_ruch ♦ An inhalation device for use in conjunction with metered dose dispensers, characterized by a chamber having an inlet and an outlet and a volume substantially less than the normal human respiratory volume, the chamber having a holder holding the drug delivery device Fixed to a specific position to the chamber, and is connected to a mouthpiece, wherein the mouthpiece is located on the side of the outlet of the chamber and having a Luftauslaßstutzen that a first valve is mounted at the outlet between the chamber and the mouthpiece, which is inhaled automatically opens by the device and automatically closes when exhaling, and that a second valve is connected to the air outlet of the mouthpiece in such a way that it automatically closes when inhaled through the device and automatically opens when exhaling » 2 «Inhalation device according to item 1, characterized in that 'the mouthpiece instead of the Luf¬ .tauslaßsfcutzens with valve has small openings which allow the passage of air in both directions, but have such a level that when inhaled through the mouthpiece, the majority of the breathing air through the chamber and the valve enter the patient's mouth at its outlet, 3 # Inhalation device according to item 1 or 2, characterized in that the holder for the aerosol dispenser is replaced by an adapter, with the device on one 15, 1. 1980 GZ 56 045 16 usual mouthpiece for aerosol dispensers can be fixed by plugging on » 4 »inhaler of item 1 to 3, characterized in that it is designed telescopically ι" Here are the drawings