WO2019212442A2

WO2019212442A2 - Inhaler usage monitoring method

Info

Publication number: WO2019212442A2
Application number: PCT/TR2019/050141
Authority: WO
Inventors: Merthan OZTURK; Kerem YASAR; Ahmet OGUZ; Burak SONMEZ; Ahmet Burak AKTAS; Kadir Tayyip TASLICA
Original assignee: Inofab Saglik Teknolojileri AS
Current assignee: Inofab Saglik Teknolojileri AS
Priority date: 2018-03-16
Filing date: 2019-03-06
Publication date: 2019-11-07
Anticipated expiration: 2020-09-16
Also published as: WO2019212442A3

Abstract

The invention is related to an inhaler usage monitoring method which monitors the correct use of an inhaler intended for delivering medicine to the lungs. The method involves determination of a beginning segment of the inhalation duration, allowing more detailed assessment of parameters corresponding to drug release and flow rate. The manner of performing the method subject to the invention by means of an inhaler attachment or an inhaler is also described.

Description

INHALER USAGE MONITORING METHOD

Technical Field

The invention is related to an inhaler usage monitoring method which enables the monitoring of the correct use of an inhaler device intended to deliver medication to the lungs and which records information such as the number of uses and time of usage.

Prior Art

In order to deliver medication to the lungs, inhalers which aerosolize drugs by letting the air pass through a restricted cross-section during the user's inhalation are used. In order to prevent the medication from accumulating at a different part of the respiratory tract without reaching the lungs, the user needs to inhale at a particular rate. Solutions developed with the purpose of providing feedback to the user regarding the correct inhalation rate are known in the art. Inhalers have been described in the document numbered US2016256641A1 in which inhalation is carried out through a straw along the airway, and in the document numbered GB25146S2A, by means of using a narrow section along the airway or an electronic sound generator which generates sound when correct inhalation takes place.

In order to detect the proper use, the air flow and drug release should be measured.

In the document numbered GB2542910A, a system in which a drug capsule is pierced and the air flow is detected by the measurement of related sounds has been explained. It was indicated that the sound measuring process is started in the case that a wearable device on the user and the inhaler are in the proximity of each other at a particular distance.

In the document numbered WO2016116629A1, creating an air flow profile by means of sound measurement (measurement of the end frequency and the frequency band) has been explained.

In the document numbered WO2016111633A1, a controller for an inhaler has been explained. It was stated that a record of the drug release is created in the case that an acoustic signal / acoustic signature related to drug release is received. It is also stated that the release which take place within a minimum duration after the hatch is detected to have been opened by a sensor and for a minimum period of time before the device is shut down can be monitored in order to create a record of drug release. In the document numbered US2017100550A1, an inhaler which monitors the use by means of measuring sound or vibration is described. Elimination of noise is provided by performing sound measurements even in noisy atmospheres by means of the two sensors along the airway. It has been determined that sound created by the drug can be measured and problems such as premature drug release or short breaths can be detected by distinguishing the release of the drug from the sound of respiration.

In the document numbered WO2009155581A1, a method which analyzes the sound signals generated by the inhaler and provides feedback to the user is described. Real time feedback can be provided to the user by means of for example, a time-dependent pressure graphic. It was stated in the document that the areas corresponding to proper use or failure would be marked on this graphic.

Aim of the Invention

The aim of this invention is to develop an inhaler usage monitoring method which enables to control that the user has inhaled the drug with a correct inhalation rate and duration during the use of the inhaler. Another purpose of this invention is to develop an inhaler usage monitoring method which provides feedback to the user.

Another purpose of this invention is to develop an inhaler usage monitoring method which can create a profile of the air flow.

Another purpose of this invention is to develop an inhaler usage monitoring method which has low energy consumption.

Another purpose of this invention is to develop an inhaler usage monitoring method which enables recording time of inhaler use. Description of the Figures Illustrating the Invention

The figures and their related description in order to further explain the inhaler usage monitoring method developed by this invention can be found below.

Figure 1 is the front view of a dry powder inhaler. Figure 2 is the side view of a dry powder inhaler.

Figure 3 is the front view of a dry powder inhaler with an inhaler attachment.

Figure 4 is the side view of a dry powder inhaler with an inhaler attachment.

Figure 5 is the front view of a metered dose inhaler.

Figure 6 is the side view of a metered dose inhaler. Figure 7 is the front view of a metered dose inhaler with an inhaler attachment according to the invention.

Figure 8 is the side view of a metered dose inhaler with an inhaler attachment according to the invention.

Figure 9 is a sample flow chart related to performing and assessing the measurements of the method according to the invention in order to monitor the use of a metered dose inhaler.

Figure 10 is a sample flow chart related to performing and assessing the measurements of the method according to the invention in order to monitor the use of a dry powder inhaler. Definition of the Parts forming the Invention

The parts and segments in the figures have been numbered, and the references of each number have been presented in below in order to better explain the inhaler usage monitoring method developed by the invention.

1. Attachment

2. Inhaler 3. Mouthpiece

4. Air inlet

5. Button

6. Canister 7. Body

8. Arm

9. Indicator

Detailed Description of the Invention

The inhaler attachment (1) which enables to perform method subject to the invention is used together with an inhaler (2) which comprises an airway between a mouthpiece (3), which rests on the mouth of the user, and at least one air inlet (4). The inhaler (2) also comprises a drug release mechanism which releases the medicine in order to aerosolize it by means of a drug chamber, in which at least one medicine that needs to be delivered to the lungs of the user during inhalation is filled and which keeps this medicine along the airway with the purpose of aerosolizing it during the user's inhalation. Although the method of the invention is performed by means of a hardware located on the attachment (1) that is attached to the inhaler (2) and which is absent from most common inhalers (2) in the market, it is possible to perform the method by means of the hardware already present on the inhaler (2). Therefore, the inhaler (2) only needs to have been produced in order to contain the related hardware.

In a pre-metered dry powder inhaler (2) (dry powder inhaler - DPI), the powdered medicine within a single-dose capsule or a blister containing multiple number of single dose cells is aerosolized during the user's inhalation. In order to use the dry powder inhalers that operate by means of the drug in a capsule, first of all the capsule is placed inside the drug chamber. The drug release mechanism comprises a button (5) which contains at least one needle in order to release the drug within the capsule and pushes the needle in order to pierce the capsule when it is pressed by the user. When the capsule is pierced, the powdered drug is carried by the air flow during the user's inhalation and delivered to the user. There are one or more than one air inlets (4) which have a direction that, preferably, does not intercept the direction of the airway. By this means, the air flow rotates the capsule by creating a vortex in the drug area and provides the release of the powdered drug. In addition, inhalers (2) based on transferring a specific drug amount to the drug area from a housing, instead of a capsule, are present. The drug is carried to the target are by the inhalation of the user.

In a metered dose inhaler (2) (metered-dose inhaler - MDI), a canister (6) containing a drug which is a spray fluid or which can be carried by a spray fluid is placed into the drug chamber. The drug release mechanism comprises a valve which enables a specific amount of drug to be sprayed by being triggered by the user in order to release the drug in the canister. The user triggers the drug release during their inhalation and the drug is delivered to the target area by means of the air flow provided by the user's simultaneous inhalation with the spray of the drug release mechanism.

The inhaler attachment (1) basically comprises - a body (7) which is fits on the inhaler (2) and carries the other components, at least one vibration sensor which measures the vibrations in the inhaler (2) during the user's inhalation and drug release, a processor which evaluates the data from the vibration sensor.

The attachment (1) is removable. In order to attach the attachment (1) on different inhalers (2), flexible parts can be present on the body (7) or its extensions.

The vibration sensor can be a microphone.

By means of using the data collected by the vibration sensor, information related to the air flow, for example, related to the magnitude such as the flow rate, or the possible status of the inhaler such as the drug release, is created. In an embodiment of the invention, the vibration data is compared to the recorded vibrations corresponding to possible statuses and the specific values of the related magnitude. As a result of this comparison, the magnitude and the inhaler status corresponding to the vibration sensor data can be detected. The mentioned magnitude information allows creating a profile which is composed of a graphic that enables visualizing the change of the related values, or a data set comprising the related values in relation to measurement time, by means of time and monitoring the air flow provided by the user. The status information obtained enables monitoring of the drug release. By means of using the status information, it can be detected that the drug is released and the magnitude and status information can be used together to perform the drug release at the proper respiration rate for the subject drug and detect whether this respiration rate is continued for a while after the drug release. The magnitude information and the status information can be kept in memory in the body of the attachment (1) or an external location, and notified to the user.

The proper respiration rate and duration can be different for different drugs. Therefore, the proper use information for more than one drug can be kept on the attachment (1) or a server accessible to the attachment (1). The proper use information for each drug is composed of the proper respiration rate depending on time throughout the proper respiration duration. This proper use data can be expressed as reference profiles. After the user chooses from these medications, the proper respiration rate and duration can be evaluated in the light of the proper use information defined for the chosen drug. With the reference profiles presented to the user together with the actual profile after the use or preferably, real-time, enables the user to improve themselves. The subject method basically comprises the steps of; beginning from the point that it is detected that the inhalation has started to the termination of the inhalation, determining the instantaneous flow rate and recording the instantaneous flow rate and the corresponding time of measurement, - within the instantaneous flow rate and the corresponding measurement time series, determining a subseries corresponding to the beginning segment of the inhalation process, calculating at least one variable which will be evaluated during the inhalation process and within the beginning segment, retrieving the variable values corresponding to the proper inhalation manner, comparing the calculated and proper values and generating a feedback in line with the comparison results.

Vibration data is, preferably, used for detecting that the inhalation has started and ended and for the measurement of the instantaneous flow rate.

The drug can reach the farthest point possible within the lungs right after the start of inhalation. Thanks to determining the data subseries corresponding to the beginning segment, this stage can be evaluated efficiently. The beginning segment is a specific ratio of the inhalation time or a specific period of time starting from the commencement of the inhalation time. This proportion or duration can be predefined as well as being adjusted according to the drug or the user's need.

The variables to be evaluated correspond to at least one factor which affects the delivery and dissipation of the drug to the lungs, such as the time of drug release, the flow rate provided following the drug release, total inhalation time, total inhalation volume and the duration time that falls within the beginning segment following the drug release and the highest flow rate within the beginning segment following drug release.

The variable values that correspond to proper inhalation manner can be retrieved from a memory or a server.

In a preferred embodiment of the invention, variable values which correspond to proper inhalation manner for more than one medication can be used. By this means, use of the drugs which differ from each other in terms of the best manner of delivery and dissipation to the lungs can be provided. Therefore, the method subject to the invention comprises a drug selection step. This step is preferably carried out once, and the drug preference is saved and used each time the method is performed. Nevertheless, it is possible to select the drug again each time the method is performed, hence, at each time of use.

An exemplary embodiment of the invention for monitoring the use of a metered dose inhaler (2) basically comprises the steps of; (101) detecting the beginning of inhalation,

(102) detecting instantaneous flow rate,

(103) recording the instantaneous flow rate and the corresponding time of measurement, (104) determining the flow rate in the case that the inhalation is detected to be continued and repeating the steps of recording the instantaneous flow rate and the corresponding time of measurement,

(105) determining the subseries corresponding to the beginning segment,

(106) detecting the drug release,

(107) recording the time of drug release,

(108) comparing the time of drug release with the ending of the beginning segment,

(109) determining the maximum flow rate within the beginning segment from the point of drug release, (110) calculating the total time of inhalation following the point of drug release,

(111) calculating the total volume from the point of drug release,

(112) retrieving proper values according to the drug selection,

(113) comparing the calculated and proper variables,

(114) generating feedback.

Detection of the drug release can be realized by detecting that the drug release mechanism is triggered or by evaluating vibration data.

In an exemplary embodiment of the invention for monitoring the use of a dry powder inhaler (2), the steps 106, 107 and 108 do not take place regarding the detection and evaluation of drug release. That is because the drug release is performed before inhalation and the drug is ready to be aerosolized during inhalation.

In a preferred embodiment of the invention, the following steps of;

(115) creating a reference profile by using proper values and (116) creating an inhalation profile by using the instantaneous flow rate and the corresponding times of measurement are also carried out. The output data of these steps is presented to the user. Preferably, the reference profile and the inhalation profile are presented to the user in real-time.

When the drugs are required to be taken at specific time intervals, the conformity of the user to these intervals can be monitored by means of the attachment (1). Therefore, the time information related to the usage can be saved and notified to the user or the related healthcare personnel. The time information comprises the date and hour the attachment (1) is used.

The attachment (1) can also comprise means such as an accelerometer or a gyroscope in order to determine whether the inhaler (2) is held in the correct position during use. Thereby, the angle of the inhaler (2) during different stages such as drug release and inhalation can be determined and compared to the angles required for these stages to be performed correctly. The correct use of the drugs which need to be shaken prior to use can also be detected by the accelerometer. The attachment (1) can also comprise positioning hardware which enables to determine the location of the user. By means of monitoring the location of the user, the conformity of the schedule determined for the regularly used drugs to the user's daily life can be developed or the reason behind the user's need for the drugs can be determined if necessary. The attachment (1) comprises at least one connection device in order to send data and notifications to external devices such as a smartphone. The connection device is preferably compatible with at least one of the common wireless connection types such as Bluetooth or Wi-Fi. The connection device can be compatible with cabled connection types instead of wireless connection types or with both cabled and wireless connection types.

The attachment (1) can comprise at least one indicator (9) which is located on the body (7) and which provides instructions and feedbacks related to the usage. The indicator (9) can be composed of at least one LED and/or screen. The instructions and feedbacks can be presented to the user by means of changing the color and/or intensity of one LED or activating more than one LED linked with different specifications regarding use. Symbols explaining the meaning of the feature can be found next to or on the LED's linked with different features of use. For example, while the LED's related to the angle and inhalation rate provide feedback to the user in order to prompt a change, a LED related to the duration of the inhalation can instruct the user to continue or end the application. Instructions and feedbacks can be presented to the user by means of a real time graphic that shows text, animations, symbols or the flow of air.

The attachment (1) used with a dry powder inhaler (2) comprises arms (8) which partially overlap with the buttons (5) of the drug release mechanism in the inhaler (2) and which move according to the body (7) as the user presses the buttons (5). Arm movement sensors which determine the movement of the arms (8) according to the body (7) have been provided. Bu means of these arm movement sensors, it can be determined that the drug release mechanism is triggered.

The mentioned arm movement sensors can be potentiometers at the connection points of the arms (8) with the body (7), a circuit which detects the interaction between the electrical, magnetic, infrared or ultrasonic components positioned opposite to each other on the arm (8) and the body (7), or a component which measures the force created on itself with the movement of the arm (8) according to the body (2), which is located on the arms (8) or at the point where the arms (8) are connected to the body (7). The arms (8) can move angularly around the point the arms (8) are connected to the body (7) or in a linear form according to this point.

The arms provide the fastening of the attachment (2) to the inhaler (1). Therefore, the distance between the internal points of the opposite arms (8) is shorter than the distance between the external points of the opposite buttons (5). At the internal part of the arms (8), recesses fitting on the buttons (5) are present. In this manner, the attachment (1) fastened onto the inhaler (2) can be fixed by means of flexing the arms (8).

The attachment (1) also comprises a power source which enables the sensors, processor, connection device and the indicators (9) to operate. The power source comprises a battery housing which contains one or more than one battery, a charging device which provides for the batteries to be charged with the battery housing, and one or more than one element which provide the supply of electrical energy such as a wireless power transmission device which is connected to an external source without contact.

In one embodiment of the invention, when it is in a standby mode in which the vibration sensor is not activated, the attachment (1) becomes activated after the drug release mechanism is determined to have been triggered by arm movement sensors. Thereby, it is provided that the attachment (1) is operated with all of its elements only during the drug intake, the energy consumption of the attachment (1) is decreased and the data compiled and transmitted by the attachment (1) is cleared from redundant input. The vibration sensor can be brought to the standby mode again after a predefined period has passed following its activation or it is detected that the user performed the drug release and the air flow has ended. In this case, the method of the invention can comprise the step of initiating the measurement (117) before the beginning of inhalation is detected.

Claims

1. An inhaler (2) usage monitoring method, comprising the steps of; determining the instantaneous flow rate and recording the instantaneous flow rate and the corresponding time of measurement, beginning from the point that it is detected that the inhalation has started to the termination of the inhalation, calculating at least one variable which corresponds to at least one factor that affects the delivery and dissipation of the drug to the lungs during inhalation, retrieving values of the variable corresponding to the proper inhalation manner, comparing the calculated and proper values and generating a feedback in line with the comparison results characterized by; determining a subseries corresponding to the beginning segment of the inhalation process within the instantaneous flow rate and the corresponding measurement time series, also ca lculating at least one variable which corresponds to at least one factor that affects the delivery to and dissipation of the drug in the lungs within the beginning segment.

2. An inhaler (2) usage monitoring method according to Claim 1, characterized by a beginning segment which is a specific ratio of the inhalation time from the commencement of the inhalation time.

3. An inhaler (2) usage monitoring method according to Claim 1, characterized by a beginning segment which is a specific period of time starting from the commencement of the inhalation time.

4. An inhaler (2) usage monitoring method according to Claim 1, characterized by being able to retrieve variable values that correspond to the proper manner of inhalation in relation to more than one drug.

5. An inhaler (2) usage monitoring method according to Claim 4, characterized by a drug selection step.

6. An inhaler (2) usage monitoring method according to Claim 5, characterized by recording the drug selection.

7. An inhaler (2) usage monitoring method according to Claim 1, characterized by determining the drug release during the monitoring of the usage of the metered dose inhaler (2) and recording the drug release time.

8. An inhaler (2) usage monitoring method according to Claim 1, characterized by establishing a reference profile using proper values and an inhalation profile using the measurement times corresponding to instantaneous flow rate and presenting these profiles to the user.

9. An inhaler (2) usage monitoring method according to Claim 1, characterized by presenting the reference profile and the inhalation profile to the user in real time.