KR100852476B1 - Apparatus for administering aerosols - Google Patents

Abstract

The present invention relates to a fixed inhalation device for individual controlled inhalation of therapeutic aerosols, comprising: a drug release means 3, at least one drug reservoir 2, a reader 4 for reading the individual parameters and / or aerosol parameters of the patient stored in the memory means; And a control unit connected to the drug release means 3 and the reader 4 for releasing the drug. This fixed inhalation device 1 allows the administration of other drugs to most patients.

Description

Aerosol administration device {APPARATUS FOR ADMINISTERING AEROSOLS}

1 shows a schematic view of a preferred embodiment of a fixing device according to the invention.

The present invention relates to a device for administering an aerosol, in particular a stationary device for administering a therapeutic aerosol in a controlled manner.

During today's long flights, the number of people suffering from acute thrombosis is increasing and the risk of developing thrombosis should not be underestimated. The risk is even higher when a person is sitting in a cramped and cramped state for a very long time and furthermore suffers from peripheral circulatory disorders. To date, the only known way to reduce this risk is to inject a heparin preparation before departure (usually Low-molecular-weight Heparin). However, this injection method is rarely applied because the injection involves and complicates other new risks and is very unpleasant for each passenger.

It is known that low molecular weight heparin can also be administered largely by inhalation. Thus, a prophylactic effect can be obtained in the blood. However, low molecular weight heparin has never been administered by inhalation, since the exact dosage has not yet been determined for inhalation; However, dosage is an important aspect of this drug.

To date, the administration of drugs in the form of aerosols in inhalation therapy has failed mainly due to patient coordination problems and breathing means. The term describes the patient's breathing depth and respiration rate, how much the patient breathes, and when the drug is released during inhalation while the patient inhales. A deeper aspect to be considered is the physical properties of the aerosol, ie the size, humidity value or electrostatic force of the aerosol particles being inhaled. In order to accurately determine the dosage of the drug, it is necessary to know the secretory properties of the individual compartments of the respiratory tract. Each parameter must then be selected based on these characteristics to ensure the administration of the drug into the lungs. In the case of heparin described above, the active ingredient must go deep into the lungs to reach the air / blood barrier of the alveoli. Only then can heparin get into the blood to get the intended effect.

Both overdose and underdose of the active ingredient are problematic. Insufficient administration is dangerous because heparin does not effectively prevent thrombosis and the aforementioned risks are not eliminated. However, if an active ingredient such as heparin is overdosed, there is a risk of internal or external bleeding due to the reduced coagulation of blood.

In practice, the following problems arise when the drug is administered in the form of an aerosol.

1. A large number of obstructive patients can no longer progress the respiratory flow necessary for optimal aerosol application;

2. Many of these patients, patients with emphysema, or all patients above with very low lung volume, have only very limited tidal volume;

3. All patients inhale at different rates and in different volumes, resulting in a wide and varied range of drug dosages in the lungs.

The present invention relates to the inhalation of heparin as well as other active ingredients. Alternative treatments for drug addiction create similar problems. Although inhalation is more efficient and further reduces the risk of infection, alternative agents have been administered in the form of injections to date.

EP-A-0 587 380 describes a drug delivery device which only administers the drug during the inhalation phase of the breathing cycle, which recognizes inhalation and is comfortable for the patient to breathe. Moreover, this comfort varies from patient to patient, with varying doses. As for the feasibility of this, this drug transport device is inadequate for long distance flights, for example, because all patients must carry it for the administration of heparin as a means of preventing thrombosis, which is very inconvenient.

The dose of therapeutic aerosol to be inhaled has so far been very inaccurate and heavily dependent on biological morphology and geometry. In addition, this dose is greatly influenced by the patient's individual breathing means. In the worst case, the active ingredients never reach the part of the lung where the drug is to be administered. Even more disadvantageous is that other inhalations-even in the same patient-occur because of an overdose of the active ingredient. Usually the physical aerosol properties can be easily adjusted and reproduced, while the parameters dependent on the patient cannot be adjusted at all.

Simple portable devices or sprays, in which the administration of dry powders is freely controlled, are very disadvantageous in that personal dosing is impossible. This can only be done by a complex personal inhalation system. However, the patient may also have to take the device because it can overdose by inhaling too much, and moreover is also needed during the return flight, for example in the case of a long flight. Every patient needs his own device, so each one is enormously expensive.

Alternatively, it is an object of the present invention to provide an improved device for inhalation of individually controlled therapeutic aerosols, which is available to many patients despite the characteristics already possessed by the individual. This object is achieved by the points of the claims.

The present invention provides a fixed device for inhalation of individually controlled therapeutic aerosols. The present fixation device includes at least one drug reservoir to allow one or more active ingredients to be provided to a user. The fixture also includes a drug release means, which preferably consists of a pump, a metering means and a disperser. Furthermore a reader is provided for reading the memory means; In this memory means individual parameters of the patient and / or aerosol parameters for inhalation are stored.

According to a preferred embodiment, the individual parameters of the patient are stored in memory means usable by the designated smart card, flashcard, smart label. Individual parameters are stored in the memory means based on, for example, measurements of the patient's current lung function (eg performed by a family physician). The patient carries this memory means and inserts it into the individual fixing device according to the invention as necessary. The fixing device according to the invention also comprises a control unit connected to the drug release means and the reader. The control unit starts up the drug release means as a function of the individual patient and / or aerosol parameters stored in the memory means and provides the patient with an appropriate aerosol dose in the drug reservoir. Generate a first flow (spray flow) to the aerosol, if possible a second flow (preliminary flow) of additional air supplied to the spray flow. The patient inhales this dose. Since aerosol precipitation in certain areas of the lung is known to depend on the particle size of the active ingredient, tidal volume, respiratory flow, and aerosol precipitation in the lung can be essentially predetermined and precisely controlled. The patient experiences a pleasantly controlled respiratory action because it is suitably controlled for the individual needs of the patient.

Preferably, the respiratory action of the patient is recently performed with the inhalation device stored in the memory means inserted into the inhalation device during each inhalation so that the administration can be controlled and the lungs can be recharacterized when the treatment time has elapsed. .

In a more preferred embodiment, the memory means is also reprogrammed to adapt the parameters for correct breathing action for any change in the lung function of the patient.                     

Preferably, the inhalation device according to the invention prevents overdose, for example by pre-adjusting the cycle of operation or shutdown in the memory means. This prevents the fixed inhalation device according to the invention from being reactivated by the patient unless the required time period between two consecutive inhalations has elapsed.

In a more preferred embodiment, the inhalation device according to the invention takes into account the body's response to the drug of the administered drug, ie the time required to catalyze the drug. For example, heparin completely metabolizes within three days. If a person has inhaled heparin prior to boarding the plane using the inhalation device according to the invention and after two days before the departure of the next flight (returning flight), heparin will not fully metabolize and only a minimal amount will be administered. To achieve this the body's response to the drug is also stored in the storage means and read by the reader along with other parameters.

Preferably, the memory means are also useful for writing errors. The memory means records, for example, whether the spray pressure deviates too much from the desired range or if the required spray pressure cannot be increased at all. The memory means also preferably records any safety device interruption when the mouthpiece pressure (positive pressure breathing) is too high. In a more preferred embodiment, too large a deviation of the recorded flow (the aerosol spray flow or the supplementary flow of additional air supplied to the aerosol air, or the sum of the two flows) is recorded or one of the aforementioned flows for intake If cannot be incremented, an error message is logged. Preferably, the end of inhalation by the patient is also recorded.

1 shows a preferred embodiment of a fixed inhalation device according to the invention, according to FIG. 1, a preferred embodiment of the inhalation device 1 according to the invention comprises a drug reservoir 2. This drug reservoir 2 is connected with the drug release means 3 via a connector 35. The drug release means 3 comprise a dispensing means 33 for generating an aerosol and a dosing means 32; The drug to be released is administered to the patient via a tube system 34. For drug release, there is also a reader 4 in which each patient and / or aerosol parameter can be read from a memory means such as a smart card. The pump is connected to the dosing means or discharge nozzle via a connector 36. A pump 31 is provided, and the control unit regulates aerosol release based on the read data. As a result, the screen 5 is provided through proper indication by the patient.

According to the invention, the patient inhales in a fixed device in an exposed position. For prevention with heparin, for example, these fixed suction devices according to the invention are placed in airport terminals. The fixed inhalation device according to the invention, each filled with a drug or even another drug, can be activated by a memory means such as a smart card. For this purpose, the patient is provided with a chip-like memory means in which individual respiratory action information as well as drug data and drug doses can be optimized for their own prevention. The patient inserts the memory means into a separate reader 4 of the fixed suction device 1 and installs, for example, a disposable mouthpiece in a separate adapter or tube system 34 of the suction device 1. As soon as the patient inhales with this mouthpiece, the inhalation device 1 according to the invention is activated automatically and the control unit releases the individual dose of the appropriate drug to the patient while activating the drug release. The inhalation device automatically shuts down when the patient inhales the required dose. To prevent overdose, the use of the same or different terminal device blocks the memory means. Thus, the patient cannot inhale the amount of drug required before the predetermined period of time has elapsed. Also, considering the body's response to the drug, the dose of the drug would only be allowed to take into account the history of inhalation (interval after the last inhalation). Preferably, the debit note guarantees the individual medication stored and prescribed on the memory means / chip. Indeed, general practitioners or pulmonary specialists may make prescriptions in memory means that include individual patient or aerosol parameters shown on pulmonary function tests.

In addition to standing at the airport, the fixed suction devices according to the invention are installed in other easily accessible locations, such as waiting rooms or pharmacies in railway stations or practitioners, to allow alternative treatment.

In accordance with the present invention, the drug or active ingredient is administered as a therapeutic agent for long-term swelling or cold of the respiratory tract. For this purpose a fixed suction device according to the invention is provided with an individual medicament.

The drug is in a separate drug reservoir 2 with a connector 35 on the dosage means (such as a nozzle sprayer, ultrasonic sprayer or dry powder disperser). When the memory means is inserted in the reader 4, the dosing means is automatically filled in accordance with the parameters preset in the memory means. The breathing action performed by the patient is controlled by the control unit, which also controls the pump 31. During the patient's first breath, a turbine is started that produces the pump 31 or aerosol dose and the pressure necessary to control the patient's respiration rate. The patient can only inhale at a preset rate of the inhalation device 1 according to the invention. The device stops working when it approaches the volume calculated by the control unit. The user then exhales through the air filter to prevent contamination of the inhalation device 1 or the patient leaves the inhalation device and exhales freely. During the next inspiration, individual breathing actions are resumed and performed. If the optimal dose is given, the inhalation device will automatically stop running and the screen 5 will show the patient that the dosing and inhalation is complete. The disposable mouthpiece is removed and the memory means is withdrawn from the reader 4. The tube 34 connecting between the mouthpiece and the suction device is then cleaned with a disinfectant. For this purpose, the tube is attached to a separate adapter which is connected to a separation pump which injects disinfectant through the tube 34 and is dried by the ventilation device after a period of time. The device is then ready for use for the next patient. Thus, each patient having different individual inhalation parameters and requiring different drugs will be supplied with them by the fixed inhalation device according to the invention.

Preferably, the drug reservoir 2 is cooled to reduce the formation of pathogens. Inhaled air is warmed when supplied to the patient to prevent or reduce condensation or pathogen formation in the mouthpiece. Alternatively or additionally, an ultraviolet light source is supplied to reduce or prevent pathogen formation. Individual drug reservoirs can be replenished or simply exchanged.

According to a first embodiment of the inhalation device according to the invention, the aerosol is sprayed in the device. The drug is supplied to the patient's lungs through an appropriate mouthpiece during inhalation.

According to another optional embodiment, the aerosol is sprayed out of the device and the nebulizer already containing the drug. The patient may, for example, purchase a drug nebulizer at a pharmacy (eg an airport pharmacy) and then inhale the drug using the inhalation device according to the invention; However, drug use is not optimized in this embodiment because the remaining amount remains in the nebulizer which can no longer be used.

Fixing devices for individually controlled inhalation of therapeutic aerosols according to the invention provide the following advantages.

1. Very accurate and individual dosing is possible;

2. Treatment is always possible when needed. (For example, on an airplane going out or returning to another country);

3. No need for individual device to carry;

4. Reprogrammable memory means allows individualization of drugs and patients;

5. Multiple administrations are prevented by memory means;

6. In case of rapid inhalation with each other, overdose is prevented by considering the body's response to the drug;

7. Drugs of other pharmaceutical companies may be provided and administered by a stationary device;                     

8. Respiratory action can be controlled and drug release can be applied for each patient; And

9. The reproduction of drug release was increased.

Claims (8)

Drug release means 3; At least one drug reservoir (2) connected to the drug release means (3); A reader 4 for reading at least one of the individual parameters and the aerosol parameters of the patient stored in the memory means; And For individual controlled inhalation of a therapeutic aerosol comprising the drug release means 3 for releasing the drug and a control unit connected to the reader 4 depending on the patient's individual parameter and at least one reading of the aerosol parameter. Fixed suction device. The method of claim 1, Fixed inhalation device for individual controlled inhalation of therapeutic aerosol, wherein the drug release means (3) comprises a pump (31), a dosage means (32) and a disperser (33). The method of claim 2, Fixed inhalation device for individual controlled inhalation of a therapeutic aerosol, wherein the dosing means (32) is a nozzle nebulizer, an ultraviolet nebulizer or a dry powder disperser. The method of claim 1, Wherein said memory means is a flashcard, a smart card or a smart label memory means. The method of claim 1, A fixed inhalation device for individual controlled inhalation of therapeutic aerosols, wherein the memory means stores the respiratory action performed. The method of claim 1, Fixed inhalation device for individual controlled inhalation of therapeutic aerosols, which evaluates and relies on the information of at least one of individual parameter information and aerosol parameters of the patient read by the control unit to control respiratory flow, tidal volume and drug dose of the inhalation device . The method of claim 5, A fixed inhalation device for individual controlled inhalation of therapeutic aerosols, wherein the control unit for adjusting the drug dose further takes into account the body's response to the drug of the drug. delete

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