JP2003325666A - Device for controlling aerosol - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a stationary sucking device for controllably sucking aerosol for treatment. <P>SOLUTION: This device for controlling aerosol comprises a chemical release means 3, at least one chemical reservoir 2, a reader 4 for reading aerosol parameters stored in a memory means and/or patient parameters, and a control unit connected to the chemical release means 3 and the reader 4. Chemicals are released as the function of the read parameters. The stationary sucking device 1 allows the control of the chemicals different for a large number of patients. <P>COPYRIGHT: (C)2004,JPO

Description

Detailed Description of the Invention

[0001]

FIELD OF THE INVENTION The present invention relates to devices for managing aerosols, and more particularly to stationary devices for managing therapeutic aerosols in a controlled manner.

[0002]

BACKGROUND OF THE INVENTION Today, many people who suffer from acute thrombotic tendencies travel during long-haul flights and the risk of developing thrombosis must not be underestimated. This risk occurs when a person sits cramped for a very long period of time and suffers from peripheral circulatory disorders. To date, the only accepted prior art methods to minimize this risk have included injecting heparin formulations (usually low molecular weight heparin) prior to departure. But not only is injection complicated, with other and new risks,
This precaution does not yet apply very well, as it is also very uncomfortable for each passenger.

[0003]

It has been discovered that low molecular weight heparins can, in principle, also be administered by inhalation. In this way, a prophylactic effect can be achieved in the blood. However, low molecular weight heparin
It was not administered in practice by the inhalation method. The exact dose has not yet been determined for the inhalation method. However, dosage is an important aspect for this drug.

Heretofore, doses of drugs in the form of aerosols for inhalation therapy have failed primarily due to patient coordination problems and his (her) respiratory maneuvers. This term describes the depth and rate of breathing of the patient, how many breaths the patient makes, and at what point during the inhalation the drug is administered as the patient breathes. Further aspects which have to be taken into account consist of the physical properties of the aerosol, ie the size of the aerosol particles inhaled, all hygroscopic properties or electrostatic forces etc. In order to accurately determine drug dosage, it is necessary to know the secretory properties of individual compartments of the respiratory tract. The respective parameters for guaranteeing the drug dose to the lungs must then be selected on the basis of these properties. In the above case with heparin, the active ingredient must penetrate deeply into the lungs in order to reach the air / blood barrier of the alveoli. Only then can heparin enter the blood where the intended effect is achieved.

The active ingredient is problematic both above and below the dose. Below the dose is dangerous. This is because in the case of heparin, thrombosis is practically not prevented and the risks mentioned above are not excluded. However, if the active ingredient such as heparin is overdose, there is a risk of internal and external bleeding due to the reduced coagulation power of the blood.

As a practical matter, the following problems occur when the drug is administered in the form of an aerosol. 1. Many patients with severe obstructive ventilation (obstructive pat)
ients) are no longer able to produce the necessary respiratory flow that must occur for optimal aerosol application. 2. In particular, many patients with pulmonary emphysema or with very small lung volumes have only a very limited respiratory capacity. 3. Since every patient breathes into the lungs at different rates and with different volumes, the drug dose in the lungs varies widely.

The present invention relates to inhalation of heparin,
The same applies to other effective ingredients. Replacement therapies for narcotics support similar problems. Inhalation is more effective and reduces the risk of infection, but replacement drugs have heretofore been administered in the form of injections.

EP-A-0 87 380 describes a drug delivery facility that is approved for inhalation. There, the patient administers medication only during the inhalation phase of the respiratory cycle while he / she freely breathes. This freedom varies further from patient to patient, and therefore the doses vary considerably. With respect to its practicality, this drug delivery facility is unsuitable for the administration of, for example, heparin, as a method of preventing thrombosis during long-haul flights. It is entirely inconvenient because all patients have to carry it in the meantime.

The dose of therapeutic aerosol inhaled is
Until now it has relied entirely on imprecise and strongly biological morphometry and geometry. Furthermore, this dose is strongly influenced by the individual breathing maneuver of the patient. In the worst case, the active ingredient never reaches the part of the lung where the drug is to be administered. A further disadvantage is that other inhalations (even in the same patient) will result in overdosage of the active ingredient.
That is the result. In general, physical aerosol properties are easily controlled and reproducible, whereas patient-dependent parameters cannot be controlled at all.

A disadvantage is a simple hand-held device, which has a freely set dose of dry powder or spray, in that individual administration is not possible. This can only be achieved by complex individual inhalation systems. The patient, however, may be overdose by inhaling too much of the dose, and
He / she will have to carry it with him, for example, in the case of long-haul flights, as she also needs it for the return flight. The cost of each is considerable because every patient needs his (female) own device.

In contrast, it is an object of the present invention to provide an improved device for the individual controlled inhalation of therapeutic aerosols, which device, despite the qualities achieved, is numerous. Available to patients. This object is achieved by the features of the claims.

[0012]

SUMMARY OF THE INVENTION The present invention provides a stationar device for individually controlled inhalation of therapeutic aerosols.
y device). The stationary device includes at least one drug reservoir so that one or more active ingredients can be provided to the user. Furthermore, the stationary device comprises a drug-release means, preferably consisting of a pump, a measuring means and a disperser. Furthermore, a reader is provided for reading the storage means, in which the individual parameters of the patient and / or aerosol parameters are stored for inhalation. According to a preferred embodiment, individual parameters of the patient are stored in a storage means available under the symbolic smart card, flash card or smart label. The individual parameters are stored in a storage means (e.g., performed by a family doctor), for example for a current lung function measurement of the patient. The patient carries this storage means with him and, if necessary, inserts it into the respective emplacement device according to the invention. Furthermore, the stationary device according to the invention comprises a control unit connected to the drug-releasing means and the reader. The control unit activates the drug-release means as a function of individual patient and / or aerosol parameters stored in the memory means and provides the patient with an appropriate aerosol dose from the drug reservoir. A first stream from the aerosol (atomizer stream) and, if any, a second stream of additional air (auxiliary stream) that is provided to the atomizer stream is created. The patient inhales this dose. Since aerosol deposition in a particular area of the lung depends on the particle size of the active ingredient, the volume of breathing and the flow of breathing, aerosol deposition in the lung can therefore be essentially predetermined and accurate. Can be controlled. The patient feels comfortable and experiences controlled breathing maneuvers as it fits his (woman) 's individual needs.

Preferably, during inhalation, a memory means inserted into the inhaler device allows each of the patient's breathing maneuvers currently performed on the inhaler device to be stored and controlled to control the specifics of the therapy. Over time, the lungs will be re-characterized.

In a further preferred embodiment, the memory means are further reprogrammable to adapt the parameters to the correct breathing maneuver for any alteration of the patient's lung function.

Preferably, the inhalation device according to the invention prevents overdose by presetting the operating time or the operating block, for example in a memory means. This prevents the patient from reactivating the stationary inhalation device according to the invention unless the necessary period between two consecutive inhalations has elapsed.

In a further preferred embodiment, the inhalation device according to the invention comprises a pharmacokinetic of the administered drug.
etics), that is, the time required to catabolize the drug. Heparin, for example, is completely catabolized within 3 days
(dissimilate) When a person inhales heparin with the inhaler according to the invention, heparin is not completely catabolized and only a minimum dose is administered before boarding a flight and before the flight (return) two days later. There must be. To achieve this, the pharmacokinetics of the drug are also stored in the storage means and readout by the reader along with other parameters.

Preferably, the memory means also serve to record the error. For example, it is recorded whether the atomizer pressure is too great to deviate from the desired range, or if the required atomizer pressure is not established at all.
Furthermore, if the pressure on the mouthpiece (positive pressure breathing) becomes too high, the memory means preferably records a safety cutoff. In a further preferred embodiment too high deviations of the flow (either the atomizer flow of the aerosol or the auxiliary flow of additional air supplied to the aerosol air or the sum of both flows) are recorded or for inhalation An error message is logged if one of the streams mentioned before is not established. Preferably, the end of inhalation by the patient is also recorded.

The stationary device according to the invention for the individual controlled inhalation of therapeutic aerosols offers the following advantages: 1. Very precise and individual doses are possible. 2. The therapy is always available when needed (eg, for outbound and return flights). 3. No need to carry a separate device. 4. Drug and patient personalization is possible with programmable memory means. 5. Multiple drugs are prevented by the memory means. 6. Overdose in the case of inhalations that follow one another rapidly is prevented by considering the pharmacokinetics. 7. Different drugs from different manufacturers can be provided and can be administered by the stationary device. 8. Breathing maneuvers can be controlled and drug release can be tailored to the individual patient. 9. The reproducibility of drug release is increased.

[0019]

DETAILED DESCRIPTION OF THE INVENTION According to FIG. 1, a preferred embodiment of an inhalation device 1 according to the invention comprises a drug reservoir 2.
This drug reservoir 2 is connected to the drug-releasing means 3 by a connector 35. The drug releasing means 3 includes a dosing means 32 and a disperser 33 to generate an aerosol. The drug to be released is administered to the patient by the tube system 34. Pump 3 connected to said dosing means or slack valve by connector 36 for drug release
1 is provided. Furthermore, a reader 4 is provided by which the individual patient and / or aerosol parameters will be read from a memory means, such as a smart card. The control unit controls the aerosol emission based on the read data. Finally, the screen 5 is provided. The patient is instructed accordingly.

According to the invention, the patient is placed outside (e
xposed position) Suck up to the lungs with a stationary device. For heparin prophylaxis, for example, a stationary inhaler according to the invention is arranged at the airport terminal. These stationary inhaler devices according to the invention, which are filled with the respective medicament or different medicaments, can be activated by a memory means, such as a smart card. For this purpose, the patient is provided with a memory means, in the form of a chip card, in which his (female) individual breathing maneuvers as well as the drug and drug dose data are stored, which is optimal for this patient. Preventive measures can be achieved. The patient inserts the memory means into an individual reader 4 of the stationary inhaler 1 and attaches, for example, a disposable mouthpiece to the tube system 34 of the inhaler 1 or an individual adapter. As soon as the patient inhales with his mouthpiece into the lungs, the inhaler 1 according to the invention
However, it is automatically set to work, and the control unit triggers drug release to release the respective dose of drug appropriate for the patient. The inhaler automatically turns off when the patient inhales the required amount of medication. Further use of the same or another end is blocked in the memory means in order to avoid any overdose. Therefore, the patient cannot re-inhale the required drug amount before the predetermined period of time has elapsed. Furthermore, if pharmacokinetics are considered, only the appropriate drug dose taking into account the history of inhalation (interval since last inhalation) is simply administered.
Preferably, the debit note is stored on the memory means / chip to ensure that the respective medication has been prescribed. As a practical matter, a general practitioner or pulmonologist can make a prescription containing in memory means individual patient or aerosol parameters by pulmonary function tests.

Besides assembling at an airport, a stationary inhaler device according to the invention may be used in stations or anterooms of medica.
l practices or other easily accessible locations such as chemist's shops to allow for replacement therapy.

According to the invention, a drug or active ingredient which causes a long-term enlargement of the respiratory tract or a medicine for the cold is administered. For this purpose, the stationary inhalation device according to the invention comprises a respective medicament.

The drug in each drug reservoir 2 has a connection 35 to the dosing means (eg a nozzle atomizer, an ultrasonic atomizer or a dry powder disperser). When the memory means is inserted into the reader 4, the dosing means is automatically filled according to the parameter preset in the memory means.
The breathing maneuver performed by the patient is controlled by the control unit controlling the pump 31. During the patient's first breath, the pump 31 or, for example, the turbine, produces the pressure necessary to control the aerosol dose and the patient's breath begins. The patient can only inhale at a predetermined rate with the inhaler 1 according to the invention. When the capacity calculated by the control unit is reached, the device is switched off. The user then exhales through the air filter to prevent contamination of the inhaler 1 or the patient leaves the inhaler and exhales freely. During the next breath, the individual breathing maneuvers are restarted and executed. If the optimal dose is reached, the inhaler is automatically switched and the screen 5 shows the dose and inhalation completion to the patient. The disposable mouthpiece is removed and the memory means is retracted from the reader 4.
Then, the pressure guiding tube 34 between the mouthpiece and the inhaler
Will be cleaned with antiseptic. To this end, the tubing is attached to individual adapters that are connected to a separation pump that pumps the disinfectant through the tubing 34, allowing the tubing to dry after a certain period of time by ventilation. The device is then ready for use for the next patient. Thus, several patients with different individual inhalation parameters and different medications required can be delivered together with it by the stationary inhalation device according to the invention.

[0024] Preferably, the drug reservoir 2 is cooled to reduce any bacterial formation. The inhaled air is warmed while it is delivered to the patient so that condensation or bacterial formation in the mouthpiece is avoided or reduced. Alternatively or additionally, a UV source is provided to prevent reducing any bacterial formation. Each drug reservoir can be refilled or simply replaced.

According to a first embodiment of the inhalation device according to the invention, the aerosol is nebulized in the device. The drug is inhaled into the patient's lungs through a suitable mouthpiece,
Supplied.

According to an alternative embodiment, the aerosol is atomized outside the device and the atomizer already contains the drug.
The patient can obtain, for example, a drug atomizer of a pharmacy (eg airport pharmacy), so that the drug can be inhaled with the inhalation device according to the invention. Every patient is him (woman)
This embodiment is more hygienic since it uses its own atomizer. However, the drug utilization method is less optimal than this embodiment. The remaining amount stays in the atomizer and cannot be used further.

[Brief description of drawings]

FIG. 1 is a device for administering an aerosol showing a schematic illustration of a preferred embodiment of a stationary device according to the invention.

─────────────────────────────────────────────────── ─── Continuation of front page (51) Int.Cl. ⁷ Identification code FI theme code (reference) A61M 11/00 300 A61M 11/00 300Z A61P 7/02 A61P 7/02

Claims (8)

[Claims] 1. A stationary inhalation device for the individual controlled inhalation of therapeutic aerosols, comprising a drug-releasing means (3) and at least one drug reservoir connected to said drug-releasing means (3). (2) and a reader (4) for reading individual patient parameters and / or aerosol parameters stored in the memory means
And a control unit connected to the reader (4) and the drug-releasing means (3) for releasing the drug as a function of the read individual parameters of the patient and / or aerosol parameters. Stationary inhaler. 2. The drug releasing means (3) is a pump (3).
Inhalation device according to claim 1, comprising 1), a dosing means (32) and a disperser (33). 3. The inhaler according to claim 2, wherein the dosing means (32) is a nozzle atomizer, an ultrasonic atomizer or a dry powder disperser. 4. The inhaler according to claim 1, 2 or 3, wherein the memory means is a flash card, a smart card or a smart label memory means. 5. An inhaler according to any one of claims 1 to 4, wherein the memory means stores the breathing maneuver performed. 6. The control unit evaluates read-out aerosol parameters for inhalation and / or individual read-out parameters of the patient to determine the respiratory flow, the volume of ventilation and the drug volume of the inhaler as a function thereof. Inhalation device according to any one of claims 1 to 5, which is controlled. 7. The inhaler according to claim 5, wherein the control unit for controlling the amount of the drug further takes into consideration the pharmacokinetics of the drug. 8. A method for administering heparin with a specific low-molecular-weight heparin or drug for preventing thrombotic agents.
Use of the inhalation device according to any one of claims 7 to 7.