WO2020005181A2

WO2020005181A2 - Inhaler attachment

Info

Publication number: WO2020005181A2
Application number: PCT/TR2019/050140
Authority: WO
Inventors: Merthan OZTURK; Kerem YASAR; Ahmet OGUZ; Burak SONMEZ; Ahmet Burak AKTAS; Kadir Tayyip TASLICA
Original assignee: Inofab Saglik Teknolojileri Anonim Sirketi
Priority date: 2018-03-16
Filing date: 2019-03-06
Publication date: 2020-01-02
Also published as: TR201803793A2; WO2020005181A3

Abstract

This invention is related to an inhaler attachment that controls the correct usage of an inhaler intended to administer a drug to the lungs. The inhaler attachment employs at least one vibration sensor that performs measurements of vibrations formed inside the inhaler during inhalation and during release of the drug. A control method related to controlling the inhaler attachment is also described.

Description

INHALER ATTACHMENT

Technical Field

This invention is related to an inhaler attachment that monitors the correct use of an inhaler for administering a drug to the lungs and that enables recording of the data such as usage count and usage time.

Prior Art

In order to convey the drug to the lungs, inhalers are used which aerosolize a drug by passing the air through a limited cross-section during inhalation of the user. The user must inhale at a certain speed in order to prevent the drug from accumulating at a different point on the respiratory track before reaching the lungs. Some solutions developed to provide feedback to the user regarding the right inhalation speed are known in the art. Inhalers that generate a sound when inhaled correctly are described in the document Numbered US2016256641A1 by a straw along the airway and in document Numbered GB25146S2A by utilizing a contraction on the air way or an electronic sound generator.

Measurements related to air flow and drug release must be performed to detect proper usage.

In the document numbered GB2542910A, a system in which the drug capsule is punctured and the air flow is detected by measuring the related sound is described. It was also stated that sound measurement is initiated by a device wearable on the user when the inhaler is closer than a certain distance.

In the document numbered WO2016116629A1, establishing an air flow profile through sound measurement (measurement of end frequencies and frequency band) is explained.

In the document numbered WO2016111633A1, a controller for an inhaler is explained. It is stated that a record is created related to drug release if an acoustic signal / acoustic signature related to drug release is received. In order to create the record for drug release, it is stated that release can be monitored after a minimum time when opening of the lid is detected by a sensor and before a minimum time when the lid is closed.

In the document Numbered US2017100550A1, an inhaler that controls the usage by sound or vibration measurements is explained. Two sensors located on the airway enable sound measurement and noise cancelling even in the noisy environments. It is stated that this inhaler can measure the drug-originated sounds and problems such as early drug release and short inhalation can be detected by distinguishing the drug release and breathing.

In the document Numbered WO2009155581A1, a method that provides feedback to the user by examining the sound signals generated by an inhaler is explained.

Object of the Invention

The object of the invention is to develop an inhaler attachment that controls whether the user inhales the drug at the correct inhaling speed and for the correct duration, during use of inhaler. Another object of the invention is to develop an inhaler attachment that provides feedback to the user.

Another object of the invention is to develop an inhaler attachment that can create an air flow profile.

Another object of the invention is to develop an inhaler attachment with low energy consumption and a control method that enables low energy consumption.

Another object of the invention is to develop an inhaler attachment that enables keeping the time data of when the inhaler is used.

Another object of the invention is to develop an inhaler attachment that can communicate data with an external device such as a smartphone. Definitions of the Figures Describing the Invention

The figures used for providing a better understanding of the inhaler attachment developed by this invention and their related explanations are given below. Figure-1 Front view of a dry powder inhaler.

Figure-2 Side view of a dry powder inhaler.

Figure-3 Front view of a dry powder inhaler with an attachment in accordance with the invention. Figure-4 Side view of a dry powder inhaler with an attachment in accordance with the invention.

Figure-5 Front view of a metered dose inhaler.

Figure-6 Side view of a metered dose inhaler.

Figure-7 Front view of a metered dose inhaler with an attachment in accordance with the invention.

Figure-8 Side view of a metered dose inhaler with an attachment in accordance with the invention.

Descriptions of the Components forming the Invention

The components and parts in the figures are given reference numbers to provide a better understanding of the inhaler attachment developed by this invention and each number corresponds to;

1. Attachment

2. Inhaler

3. Mouth piece

4. Air inlet

5. Button

6. Canister

7. Body

8. Arm 9. Indicator

Detailed Description of the Invention

The inhaler attachment (1) of the invention is used with an inhaler (2) that comprises an airway running between a mouthpiece (3) which rests on the mouth of the user and at least one air inlet (4). The inhaler (2) comprises a drug compartment in which at least one drug to be administered into the lungs of the user during inhaling is located and that keeps said drug on the air way in order to mix it with air during inhalation of the user and also comprises a drug release mechanism that releases the drug to mix it with air. A pre-dosed dry powder inhaler (DPI) (2) operates by mixing at least one drug in powder form, which is located inside a blister that contains a single-dosage capsule or a plurality of single dosage chambers, to air during inhaling. During use of dry powder inhalers that operates with a drug inside the capsule, first the capsule is inserted into the drug compartment. In order to release the drug inside the capsule, the drug release mechanism comprises at least one needle and a button (5) per needle which pushes the needle to puncture the capsule. Along with puncturing the capsule, the drug in powder form can be administered to the user by being conveyed with the air flow. Preferably, there is one or more air inlet (4) with a direction that does not interrupt the direction of air way. Thus, the air flow rotates the capsule by creating a vortex in the drug zone and releases the drug in powder form. The drug is conveyed to the targeted zone by inhalation of the user.

In a metered-dose inhaler (MDI) (2), the canister (6) which contains the drug in a sprayable fluid form or in a form that is conveyable by a sprayable fluid is inserted into the drug compartment. The drug release mechanism comprises a valve that enables spraying of a certain amount of drug after triggered by the user to release the drug inside the canister. The user, by both triggering the release of drug during inhaling and by spraying of the drug release mechanism, it reaches to the targeted zone through the air flow provided by inhalation of the user.

Basically, the inhaler attachment (1) comprises; a body (7) that rests on the inhaler (2) and that carries the other components, at least one vibration sensor that performs measurements of vibrations formed inside the inhaler (2) during inhalation of the user and during release of the drug, a processor that evaluates the data from the vibration sensor, The attachment (1) is removable. There may be flexible parts on the body (7) or on its extension to let the attachment (1) to be installed on different inhalers (2).

The vibration sensor may be a microphone.

A data can be generated by using the data collected from the vibration sensor, such as related to air flow, e.g. related to a magnitude like flow rate and related to possible states of the inhaler like drug release.

In an embodiment of the invention, the vibration data is compared to recorded vibration data corresponding to certain values of the magnitude and to possible states. As a result of this comparison, the magnitude and the state of the inhaler that corresponds to the vibration sensor data can be identified. Said magnitude information makes it possible to generate a profile that comprises a curve which enables monitoring the air flow provided by the user and visualization of the change of the related value over time. Said state information enables monitoring the release of the drug. Besides detecting release of the drug by using the state information, by using the magnitude and state information together, it is possible to detect if the release of the drug when air flow velocity is suitable for said drug and to detect if the said air velocity continues for a suitable duration after release of the drug. The magnitude information and the state information can be stored in a memory inside the attachment (1) or in an external location and it can be reported to the user.

Suitable inhalation velocity and time can be different for different drugs. Thus, suitable usage information related to more than one drug can be stored on the attachment (1) or on a server that can be accessed by the attachment (1). Suitable usage information for each drug consists of the suitable inhalation velocity depending on the time lasting during the suitable inhalation time. This suitable usage information can be stated as reference profiles. After the user selects among these drugs, the suitable inhalation velocity and time can be evaluated in the light of suitable usage information defined for the selected drug. By informing the user about the reference profiles with the realized profiles after use or preferably in real time during use, the user can improve himself/herself.

In the cases where the drugs must be administered in certain time intervals, the user's compliance with these intervals can be monitored by the attachment (1). Therefore, the time information related to usage can be stored and the user or the related healthcare personnel can be informed. The time information contains the date and time when the attachment (1) is used.

The attachment (1) may contain components such as an accelerometer or a gyroscope to detect if the inhaler (2) is correctly handled during use. Thus, the angle of which the inhaler (2) is positioned during various phases like releasing of the drug or inhaling can be detected and compared to the angles required to perform these phases correctly. The correct use of the drugs that require shaking before use can be checked by the accelerometer.

The attachment (1) may contain a positioning hardware that enables detection of the user's location. By monitoring the location of the user, it may be possible to improve the conformity of the program defined for regularly used drugs with the user's daily life or to determine where the drugs are required to be used.

The attachment (1) comprises at least one communication device to enable data transmission and sending notifications to external devices such as smartphones. The communication device is preferably compatible with at least one of the common wireless connection formats like Bluetooth and Wi-Fi. The communication device can be compatible with cabled connection formats instead of wireless connection formats or it can be compatible with both wireless and cabled connection formats.

The attachment (1) of the invention can contain at least one indicator (9) that is located on the body (7) and that enables providing the user with the instructions and feedbacks related to the usage. The indicator (9) may be at least one LED and/or one display. The instructions and the feedbacks can be presented to the user by changing the color and/or intensity of one LED or by operating a plurality of LEDs associated with different properties related to usage. There may be descriptive symbols on or at the side of the LEDs associated with the different properties related to usage. For example, while LEDs associated with the angle and inhalation speed provide feedback to the user towards changing these, an LED associated with the inhalation time may provide an instruction to continue or end the application. By a display, the instructions and the feedbacks can be presented to the user through written text, animations, symbols or a real-time curve that shows the air flow.

In a preferred embodiment of the invention, the attachment (1) that is used with a dry powder inhaler (2) comprises an arm (8) per button (5) which partially overlap with the buttons (5) of the drug release mechanism and which moves relative to the body (7) when the user pushes the buttons (5). There are arm movement sensors that detect the movement of the arms (8) relative to the body (7). Trigger of the drug release mechanism can be detected by said arm movement sensors.

Said arm movement sensors may be one potentiometer at each point where the arms (8) are connected to the body (7), a circuit that detects the interaction between the electrical, magnetic, infrared or ultrasonic components located opposingly on the arm (8) and the body (7) and a component located on the arms (8) or on the point where the arms (8) are connected to the body (7) that measures the force created thereon by the movement of the arms (8) relative to the body (7). The arms (8) can move angularly about the point where they are connected to the body (7) or they can move linearly by sliding relative to this point.

The arms (8) enable engagement of the attachment (2) to the inhaler (1). For this purpose, the distance between the inner points of the opposed arms (8) is smaller than the distance between the outer points of the opposed buttons (5). There are recesses on the inner parts of the arms (8) that fits on the buttons (5). Thus, the attachment (1) affixed on the inhaler (2) by flexing the arms (8) can be fixed.

The attachment (1) of the invention comprises a power source that enables operation of the sensors, the processor, the communication device and the indicators (9). The power source may contain a battery housing that includes one or more batteries, a charging device that enables charging the batteries with a battery housing, one or more components that provide electrical energy such as a wireless power transmission device that is wirelessly connected to an external source. In a preferred embodiment of the invention, while the attachment (1) is in stand-by mode in which the vibration sensor is not working, it can be activated after the arm motion sensors detect that the drug release mechanism is triggered. Thus, the attachment (1) is operated with all components only during drug release and both the energy consumption of the attachment (1) is reduced and the data compiled and transmitted by the attachment (1) is cleaned off of unnecessary inputs. The vibration sensor can be again put into standby mode when a predefined time passes after activation or when the termination of the air flow is detected after drug is released by the user.

Claims

1. An inhaler attachment (1) that is used with an inhaler (2) which contains an airway running between a mouth piece (3) and at least one air inlet (4), that comprises, a body (7) that rests on the inhaler (2) and that carries the other components, at least one vibration sensor performing measurements regarding the vibrations created inside the inhaler (2) during inhalation by the user and release of the drug, a processor that evaluates the data received from the vibration sensor, for a dry powder inhaler (2) that comprises at least one needle and a button (5) per needle that pushes said at least one needle to puncture the capsule in order to release the drug inside the capsule when pressed by the user that is characterized by one arm (8) per button (5) that partially overlaps with the buttons (5) and that moves relative to the body (7) when the user pushes the buttons (5), and arm movement sensors that detect the movement of the arms (8) relative to the body (7).

2. An inhaler attachment (1) according to Claim 1 characterized by arm movement sensors selected among potentiometers each located on the points where the arms (8) are connected to the body (7), a circuit that detects interactions between electrical, magnetic, infrared or ultrasonic components located opposingly on the arm (8) and the body (7), a component located on the arms (8) or on the point where the arms (8) are connected to the body (7) that measures the force created thereon by the movement of the arms (8) relative to the body (7).

3. An inhaler attachment (1) according to Claim 1 characterized by arms (8) wherein the distance between the inner points of the opposed arms (8) is smaller than the distance between the outer points of the opposed buttons (5).

4. An inhaler attachment (1) according to Claim 3 that comprises recesses which are located on the inner parts of the arms (8) and that fit on the buttons (5).

5. An inhaler attachment (1) according to Claim 1 comprising at least one wireless communication device.

6. An inhaler attachment (1) according to Claim 1 comprising an accelerometer.

7. An inhaler attachment (1) according to Claim 1 comprising a gyroscope.

8. An inhaler attachment (1) according to Claim 1 characterized by at least one LED and/or a display located on the body (7) to present instructions and feedbacks to the user.

9. An inhaler attachment (1) control method that controls the inhaler attachment (1) according to Claim 1 characterized by activating the vibration sensor after detecting the trigger of drug release mechanism by the arm movement sensors from a stand-by mode during which the vibration sensor is not working.

10. An inhaler attachment (1) control method according to Claim 9 characterized by setting the vibration sensor into standby mode again after a predefined time passes after activation of the vibration sensor.

11. An inhaler attachment (1) control method according to Claim 9, characterized by setting the vibration sensor into standby mode again after the release of the drug and termination of the air flow by the user is detected after activation of the vibration sensor.