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Title:
INHALER DEVICE DETERMINING INHALATION PROCESS
Document Type and Number:
WIPO Patent Application WO/2014/180857
Kind Code:
A1
Abstract:
The present invention relates to an inhaler device and characterized in that the said device comprises at least one electronic system giving a warning signal at the beginning and/or end of the inhalation in order to ensure inhalation and/or breathing of the user for a pre-determined duration.

Inventors:
TOKSÖZ AHMET (TR)
TOKSÖZ ZAFER (TR)
MUTLU ONUR (TR)
ERGENEKON ERCAN (TR)
Application Number:
PCT/EP2014/059255
Publication Date:
November 13, 2014
Filing Date:
May 06, 2014
Export Citation:
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Assignee:
ARVEN ILAC SANAYI VE TICARET AS (TR)
International Classes:
A61M15/00; A61M16/00
Foreign References:
US20050103337A12005-05-19
US5333106A1994-07-26
US20120247235A12012-10-04
US20070215149A12007-09-20
Attorney, Agent or Firm:
SEVINC, Erkan (Plaza-33 Buyukdere Cad., No: 33/1, Sisli Istanbul, TR)
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Claims:
Claims

1. An inhaler device is characterized in that the said device comprises at least one electronic system wherein the said electronic system comprises at least one timer which the timer provide inhalation and/or breathing of the user for a pre-determined duration.

2. The inhaler device according to Claim 1 , wherein the said device gives the visual and/or audio warning signal at the end of inhalation.

3. The inhaler device according to any of the preceding claims, wherein the said device gives the visual and/or audio warning signal at the beginning of inhalation.

The inhaler device according to any of the preceding claims, wherein the said device gives the visual and/or audio warning signal at the beginning and end of inhalation.

The inhaler device according to any of the preceding claims, wherein the said electronic element/system comprises at least one warning receiving component.

The inhaler device according to any of the preceding claims, wherein the said warning receiving component is a sensor.

The inhaler device according to any of the preceding claims, wherein the said warning receiving component is a switch.

The inhaler device according to any of the preceding claims, wherein the said switch is connected to trigger of the device.

The inhaler device according to any of the preceding claims, wherein the said sensor is sensitive to the breath of user.

10. The inhaler device according to any of the preceding claims, wherein the said sensor is sensitive to pressure or molecule or heat or combination of them.

11. The inhaler device according to any of the preceding claims, wherein the said sensor is positioned at the mouth part. 12. The inhaler device according to any of the preceding claims, wherein the said electronic element/system comprises at least one controlling element.

13. The inhaler device according to any of the preceding claims, wherein the said controlling element comprises at least one of microprocessor, processor, chip and time relay.

14. The inhaler device according to any of the preceding claims, wherein the said warning element comprises a sound and/or a light unit. 15. The inhaler device according to any of the preceding claims, wherein the said warning signal element comprises a display panel.

16. The inhaler device according to any of the preceding claims, wherein the said device is a dry powder inhaler device.

17. The inhaler device according to any of the preceding claims, wherein the said device is a metered dose inhaler device.

18. The inhaler device according to any of the preceding claims, wherein the said device is a blister dry powder inhaler device.

19. The inhaler device according to any of the preceding claims, wherein the said device is a capsule dry powder inhaler device. 20. The operation method of an inhaler device according to any of the preceding claims, wherein the said device is characterized with giving at least one warning signal for a certain period of time or at the beginning and/or end of the determined time period in order to ensure inhalation and/or breathing of the user for a pre-determined period.

Description:
Inhaler Device Determining Inhalation Process Field of Invention The present invention relates to the device which enables administration of dry powder inhalation drugs.

The present invention comprises at least one electronic system giving a warning signal in order to have the drug in inhaler devices inhaled and/or taken by breathing by the user for a pre-determined duration.

Prior Art

Diseases such as asthma, bronchitis, and COLD (Chronic Obstructive Lung Disease) substantially decrease the quality of human life, despite the developments which have been made in the diagnosis and therapy thereof in the recent years. It has been proposed to administer medicaments via inhalers for optimizing the treatment of such diseases. The inhaler route of treatment is the most preferred one and it is expected to remain so, as the first option, in the future. The most important advantage of using medicaments via inhalation is based on providing a more efficient therapy by making use of lower amounts of medicaments, delivering higher concentrations of medicaments to the airways, and particularly decreasing the systemic side effects of the medicaments. The most important causes of the lack of a satisfactory control of patients albeit the presence of quite efficient treatments against respiratory tract diseases are stated to be as the noncompliance, arising from the inefficient use of inhalers and from inadequate compliance to the physician-recommended treatments.

Nowadays, there have been developed various inhalation devices for administering inhalation medicaments. These devices are basically classified into two groups, i.e. metered dose inhalers and dry powder inhalers. These types of devices are structurally provided with basic components such as a mechanism, trigger, counter, body, mouthpiece, cap, lock, etc. Additionally, powder inhalation medicaments are kept in carriers such as blisters, capsules, etc. Blisters are composed of two basic parts, a main layer provided with cavities carrying the medicament, and a strippable protective layer. The users inhale the drug with the help of the mouthpiece on the existing dry powder inhaler devices and by breathing, and the powder drug reaches the target organ: lungs. For the blister or capsule inhalers, the drug flowing after the blister is opened or the capsule is burst is directed to the mouthpiece and kept in an area connected to the mouthpiece. The mouthpiece is designed in a volume and length suitable for mouth anatomy. By this way, both administration of the medicament is facilitated and hygiene is provided. Inhaling the air into the lungs is an active action. With contraction of inspiration muscles, the frontal posterior diameter of chest cage widens and lengthens downwards. In accordance with Boyle-Marriotte Law, as volume of gas increases, its pressure decreases. According to this law, atmospheric air fills into the lungs since the pressure of air in the widening lungs shall be lower (than the pressure of atmospheric air). The air flow occurring with atmospheric air and inclining towards the body ensures that the powder drug is taken without needing any other force. With the air flow, the powder in medicament is taken into body. Amount of the air inhaled during this process and how long it takes is very crucial.

Nowadays, there have been developed various inhalation devices for administering inhalation medicaments. These devices are basically classified into two groups, i.e. metered dose inhalers and dry powder inhalers. These types of devices are structurally provided with basic components such as a mechanism, trigger, counter, body, mouthpiece, cap, lock, etc. Additionally, powder inhalation medicaments are kept in carriers such as tanks, blisters, capsules, etc. Blisters are composed of two basic parts, a main layer provided with cavities carrying the medicament, and a strippable protective layer.

The inhalers have different methods of use according to their types, and these methods are described visually in the instructions provided with the inhalers. The basic problem in use of inhaler devices relates to the drug which becomes ready to be used after the device is triggered for use. The patient is not able to determine at which level and how long he/she will take the drug. This fact affects psychological state of the patient during treatment negatively. Especially, the problems experienced by the first users, olds and children about use of the device require embodiment of a new device. When the powder drug required to be inhaled at once is taken interruptedly, it is prevented to administer the desired dose amount to the patient, and the amount of loss waste reaches top levels. Use of the existing inhaler devices requires a certain training and practice. Development of inhaler devices always appears as systems which facilitate use of the device by the patient and which are practical. It is an important issue which device shall be convenient for the patient and how it should be selected. While selecting the device, many factors such as cognitive and physical competence of the patient, ease of use, confidence and price are taken into consideration.

In conclusion, in the field of trigger mechanism of inhaler device, a novelty is required which shall operate with desired accuracy and facilitate use of drug.

Objectives and Brief Description of Invention

The present invention is an inhaler device used for inhalation, with a warning structure eliminating all problems mentioned above and bringing additional advantages to the relevant prior art.

Accordingly, the main objective of the present invention is to provide an inhaler device which determines the pre-determined duration of inhalation and/or breathing by means of a warning system during administration.

A further objective of the present invention is to facilitate the usage coordinating inhalation process of the user.

In order to achieve all objects described above and to emerge from the following detailed description, an inhaler device has been developed.

In a preferred embodiment according to the present invention, the said novelty is characterized in that the said device comprises at least one electronic system giving warning signal in order to ensure inhalation and/or breathing of the user for a pre- determined duration.

In another preferred embodiment according to the present invention, the said electronic system comprises at least one timer. In a further preferred embodiment according to the present invention, the said device gives visual and/or audio warning signal at the end of inhalation. In another preferred embodiment according to the present invention, the said device gives visual and/or audio warning signal at the beginning of inhalation. In a further preferred embodiment according to the present invention, the said device gives visual and/or audio warning signal at the beginning and end of inhalation.

In another preferred embodiment according to the present invention, the said electronic element/system comprises at least one warning receiving component. In a further preferred embodiment according to the present invention, the said warning receiving component is a sensor.

In another preferred embodiment according to the present invention, the said warning receiving component is a switch.

In a further preferred embodiment according to the present invention, the said switch is connected to trigger of the device.

In another preferred embodiment according to the present invention, the said sensor is sensitive to breath of user.

In a further preferred embodiment according to the present invention, the said sensor is sensitive to pressure or molecule or heat or combination of them. In another preferred embodiment according to the present invention, the said sensor is positioned at the mouthpiece.

In a further preferred embodiment according to the present invention, the said electronic element/system comprises at least one control element.

In another preferred embodiment according to the present invention, the said controlling element comprises at least one of microprocessor, processor, chip and time relay. In a further preferred embodiment according to the present invention, the said warning element comprises a sound or a light unit. In another preferred embodiment according to the present invention, the said warning signal element comprises a display panel. In a further preferred embodiment according to the present invention, the said device is dry powder inhaler device.

In another preferred embodiment according to the present invention, the said device is a metered dose inhaler device.

In a further preferred embodiment according to the present invention, the said device is a blister dry powder inhaler device.

In another preferred embodiment according to the present invention, the said device is the capsule dry powder inhaler device.

In a further preferred embodiment according to the present invention, the said device is characterized with giving at least one warning signal for a certain period of time or at the beginning and/or end of the determined time period in order to ensure inhalation and/or breathing of the user for a pre-determined period.

Brief Descriptions of Figures

Figure 1 is an exemplary illustration of an inhaler device suitable for the present invention.

Detailed Description of Invention

In the following detailed description, warning system of an inhaler device according to the present invention shall be described illustratively by making references to the accompanying figures, only to make it clear without imposing any restrictions thereon.

A device according to the present invention, of which exemplary illustration is given in Figure 1 , is composed of a body having an advancement mechanism for blisters with multiple cavities. There is a mouthpiece immediately upon this body which is structured as an extension of the body. A blister advancement mechanism is placed into inner side of the body to ensure operation of the inhaler. Trigger of the device is locked to the inner side of the body. Therefore, the mechanism starts to operate and powder drug becomes ready for use after one blister is opened. Or, another device suitable for administration is the one with tank(s) into which single or multiple capsules can be placed. The capsule is burst using a pin or a needle. The drug releases.

When the user starts to take drug together with the air, the selected sensor senses pressure change, heat or one of the substance molecules. Period of use warns the user by means of a sound or a light indicator. This warning sensor may be continuous as to start with sending of the warning sensor and to finish at the end of the necessary duration, as well as it may be given twice, one at the beginning and one at the end of the process. If the system is activated by means of a lever or trigger which moves the inhaler, a warning of inhalation or breathing is initiated with a delay of 1 -5 seconds considering the period during which the user brings the device to his/her mouth.

A system has been developed which warns the user during use of the said inhaler device. Under normal conditions, a human being inhales the air of approximately 4 L at around 4 kPa pressure values. Under normal conditions, a human being breathes 12 - 14 times a minute. The device is adjusted according to suitable respiration durations taking these values into consideration. A warning system has been developed for inhaler devices in order to determine and show how this process shall be healthily.

In this warning system, the device is started with an external warning enabling operation of the device. Accordingly, a warning system has been developed which shows breathing duration of the user with triggering of a pressure-sensitive sensor - this sensor can be adjusted to operate at a certain cut-off value. If the sensor is triggered, the user is warned by means of a light, sound or an indicator during or at the beginning and end of the said warning period. In this way, the patient is able to perform inhalation in an optimum duration. Time control of this operation is made by one of the components such as microprocessor, processor, chip and time relay. This triggering operation can also be started by means of a switch to be adapted to the button/trigger which operates the inhaler devices. Here, the first warning can be given immediately after pushing as well as it can be given with a certain period of delay. For example, when the user pushes the button and after the drug is released from blister or capsule, a delayed warning can be given to allow for duration to bring to the mouth. In that way, the patient determines optimum process of use. Position of the sensor can be around the mouthpiece as well as in or around of drug taking duct.

In conclusion, thanks to the said embodiment, an inhaler device which is very accurate and operates safely and guarantees inhalation process of the patient has been developed. Designs of components used for alternative embodiments vary based on the type of the device manufactured. As a result, protective scope of the present invention is stated in the claims attached, and it is certainly not limited to the mentioned in this detailed description for the purpose of examples. It is evident that an expert of the art can reveal the similar embodiments under the light of mentioned above without straying from main theme of the present invention.