Capsule inhaler

Abstract

The present invention provides a capsule inhaler for administering a single dose of dry powder from a capsule, the inhaler comprising a body, a mouthpiece having a sieve and a mouthpiece base, and a cover having an opening connected to the body. The inhaler further comprises a capsule receiving element and a push button including a capsule puncturing mechanism. An electronic board including a microprocessor is disposed in the inhaler body, the board including a magnetic field sensor and a light indicator, and is disposed adjacent to the push button including a magnet. The magnet is positioned in the puncturing element, and the magnetic field sensor is disposed adjacent to the magnet, and the inhaler electronic board is coupled to the base of the mouthpiece via a coupling element.

Description

Technical Field

[0001] The present invention provides a smart capsule inhaler with variable resistance parameters, whereby reliable lung deposition is achieved, which is suitable for a specific pharmaceutical formulation in dry powder form encapsulated in a cellulose or gelatin capsule.

[0002] There are known devices for ensuring proper lung deposition, in both the form of a cap or accessory for an inhaler, and smart inhalers having a structure for reliably administering a complete drug dose.

[0003] UK Patent Application Publication No. 2542910 (A) discloses a device and method intended to ensure proper drug intake using a capsule inhaler that uses a user-specific band. This band includes a power source, an inhaler proximity sensor, a controller, a memory, a time measurement unit, and a communication unit. The band periodically checks the proximity of the inhaler by means of a detection sensor. This is made possible by markers provided on the inhaler, which are activated when the inhaler is detected, to collect and record data provided by the inhaler and transmit it to the home memory. One of the most important aspects of this invention is to ensure low energy consumption by the inhaler and the band.

[0004] From U.S. Patent No. 10155094(B2), a device is known that can monitor the use of an inhaler, has the form of a cap that can be applied to an inhaler, allows for the detection of the inhaler being used, and can transmit to the user information collected by the device while the inhaler is in use. The device disclosed in U.S. Patent No. 10155094(B2) may comprise a pressure sensor for detecting inhalation, a position sensor for detecting the position and orientation of the inhaler, a sensor or switch for activating the monitoring device when pressure is detected on the inhaler or when the inhaler housing is opened for administering a drug dose, and a memory for recording data obtained from the sensors during the drug administration operation. The device disclosed in U.S. Patent No. 10155094(B2) can only be used with inhalers equipped with liquid containers and, due to its structure, is not suitable for capsule inhalers, which lack the ability to control the puncture of drug-containing capsules and thus have limited applicability. The objective of the solution in U.S. Patent No. 10155094(B2) is to provide a monitoring device that is detachable from the inhaler and used in a variety of liquid inhalers, but this is only in terms of the functionality of the monitoring device, the method of assembly, and the absence of a module that can be connected to the element that performs capsule puncture, and therefore this device is not applicable to capsule inhalers.

[0005] Page 422716 of the specification discloses an inhaler for single-dose administration of dry powder, which allows for the ingestion of a drug in capsule form and has a structure that ensures lung deposition specific to each drug formulation. The inhaler disclosed on page 422716 comprises a mouthpiece, a capsule receiving chamber, a capsule puncture element, a rotating chamber, an air inlet channel, and a drug dispersal element. The inhaler ensures proper drug ingestion by ensuring the appropriate decomposition of active substance particles by a constitutive solution, the solution having adjustable constitutive parameters, which can be adjusted to a specific drug.

[0006] While devices known from the prior art provide a way to ensure that drugs are reliably administered and properly taken by the inhaler user, these relate to inhalers other than capsule-based ones. Separately, for complete monitoring, additional devices such as bands are required, or these relate to the cap rather than the inhaler itself, and do not verify that the drug-containing capsule is punctured correctly. Conventional solutions do not provide the ability to automatically send complex commands to the user and require additional memory. In particular, there is no solution to ensure comprehensive monitoring of drug intake specifically for capsule inhalers, such as verifying that the inhalation process is being performed correctly and sending appropriate feedback to the user in real time.

[0007] A capsule inhaler for administering a single dose of dry powder from a capsule, the inhaler comprising a body, a mouthpiece including a sieve and a mouthpiece base, a cover having an opening and coupled to the body, a capsule housing element, and at least one push button having a capsule puncture mechanism including at least one spring and at least one puncture element, wherein an electronic circuit board having a microprocessor is disposed within the body, the electronic circuit board including at least one magnetic field sensor and at least one optical indicator, and is positioned in close proximity to at least one push button having at least one puncture element and at least one magnet. The magnet is positioned by the puncture element, the magnetic field sensor is positioned in close proximity to the magnet, and the electronic circuit board is coupled to the mouthpiece base via a coupling element.

[0008] Preferably, the magnetic field sensor is a Hall effect device.

[0009] Preferably, the light indicator is a diode.

[0010] Preferably, the electronic substrate includes a switch which is a base aperture sensor coupled to the base of the mouthpiece via a coupling element.

[0011] Preferably, the electronic circuit board is placed within a frame that is housed inside the main body.

[0012] Preferably, the connecting element is a pressing portion.

[0013] Preferably, the capsule housing element includes a pressure drop chamber and a capsule chamber, and a pressure sensor is positioned in the pressure drop chamber adjacent to the capsule chamber at the bottom of the capsule housing element and located on an electronic substrate.

[0014] Preferably, the inhaler position sensor is located on an electronic circuit board coupled to a microprocessor.

[0015] Preferably, the position sensor is an accelerometer.

[0016] Preferably, the antenna is placed on an electronic circuit board coupled to a microprocessor.

[0017] Preferably, the antenna is Bluetooth (Registered trademark) It's an antenna.

[0018] Preferably, the connector is located on an electronic circuit board coupled to the microprocessor.

[0019] Preferably, the connector is USB-C (Registered trademark) It is a type of connector.

[0020] Preferably, an on / off switch is located on an electronic circuit board coupled to a microprocessor.

[0021] Preferably, the reset element is located on an electronic circuit board coupled to the microprocessor.

[0022] Preferably, the reset element is a reset switch.

[0023] Preferably, a real-time clock is disposed on an electronic substrate coupled to the microprocessor.

[0024] Preferably, an audio indicator is disposed on an electronic substrate coupled to the microprocessor.

[0025] Preferably, a battery is disposed within the frame.

[0026] Preferably, the body is detachably coupled to the frame by at least one coupling element.

[0027] Preferably, the coupling element is a screw or a bolt.

[0028] Preferably, an enclosure housing covering the mouthpiece and the base is provided on the body and the cover.

[0029] Preferably, the sieve comprises a mesh having rectangular openings with a width of 0.94 - 1 cm, a height of 0.97 - 1.03 cm, and a spacing between openings of 0.47 - 0.53 cm.

[0030] Preferably, the sieve comprises a mesh having rectangular openings with a width of 0.68 - 0.72 cm, a height of 1.07 - 1.13 cm, and a spacing between openings of 1.37 - 1.43 cm.

[0031] Preferably, the sieve comprises a mesh having rectangular openings with a width of 1.08 - 1.14 cm, a height of 1.07 - 1.13 cm, and a spacing between openings of 0.90 - 0.96 cm.

[0032] Preferably, a protrusion for lifting the base is disposed on the base.

[0033] Preferably, the mouthpiece base is fixed to the cover by a hinge.

[0034] The inhaler according to the present invention generates an aerosol from a solid form of a drug containing an active substance embedded in a lactose carrier under the airflow induced during the user's (patient's) inhalation. This process requires overcoming the internal and aerodynamic resistance of the inhaler. The effectiveness of inhalation depends on the formation of an inspiratory flow that ensures proper deaggregation of the drug, which determines the generation of micromolecular fractions. Subsequently, the appropriate structure of the inhaler determines the rate and nature of lung deposition, resulting in high therapeutic efficacy of the inhaled drug. The inhaler is a single-dose device in which a capsule containing the drug must be inserted into the inhaler chamber and punctured with a needle mechanism.

[0035] The main functions of the inhaler according to the present invention include the following: - Transmission of information regarding the opening and closing of the inhaler; - Measurement of the pressure drop caused by the airflow within the inhaler; - The position of the inhaler can be determined in the XYZ coordinate system; - The ability to monitor the movement of the push button used to puncture the capsule containing the drug; - Bluetooth with mobile phone (Registered trademark) The ability to establish a connection; - The inhaler memory can record data from several measurements; - Optical and audio communication with the user; - A dedicated application that allows data to be collected from the device, with user training functions for the proper use of the inhaler; - An application indicating a high probability of taking a specific drug in its entire therapeutic dose. [Brief explanation of the drawing]

[0036] The object of the present invention is shown in the following drawings: [Figure 1] The images show a front view and a side view of the inhaler according to the present invention in a closed configuration, which includes a cover. [Figure 2] An exploded view of the inhaler according to the present invention is shown. [Figure 3]A cross-sectional view of the housing of the inhaler according to the present invention is shown. [Figure 4a] The mouthpiece of the inhaler according to the present invention is shown, with the dashed lines indicating channels within the mouthpiece and the catch visible. [Figure 4b] The mouthpiece of the inhaler according to the present invention is shown, and the dashed lines indicate channels on the inside of the mouthpiece other than those in Figure 4b, where the catch is visible. [Figure 5] The base of the mouthpiece of the inhaler according to the present invention is shown in a bottom view, and the inlet channel and rotating chamber are visible. [Figure 6] The base of the mouthpiece of the inhaler according to the present invention is shown in an isometric bottom view and an isometric top view, respectively. [Figure 7-9] The side view, top view, and isometric view of the sieve are shown. [Figure 10] An isometric top view of the cover is shown. [Figure 11] The images show the capsule containment elements, with isometric views of the bottom of the element, the top of the element, and a top view of the element, respectively. [Figure 12] This shows the puncture mechanism of the push button of the inhaler according to the present invention. [Figure 13] The frame of the inhaler according to the present invention is shown. [Figure 14] The main body of the inhaler according to the present invention is shown. [Figure 15] This diagram illustrates the power supply for the inhaler according to the present invention. [Figure 16] This shows the electronic circuit board of the inhaler according to the present invention.

[0037] In the embodiments shown in Figures 1 and 2, a capsule inhaler for administering a single dose of dry powder from a capsule comprises a cover 5 hinged to a base 4 of a mouthpiece 2, and a body 14 connected via a catch. A sieve 3 is fitted into the upper opening of the base 4, and the mouthpiece 2 can be closed from above by the housing 1. In the central "inner" portion of the base 4 is a rotating chamber 4.2, to which two inlet channels 4.3 open from opposite sides, drawing air through the channels. On the base 4, for example, a projection 4.1 is provided to lift the base 4.

[0038] Cover 5 covers the capsule housing element 6, which may be made of, for example, transparent plastic, to allow monitoring of the inside of the element to determine whether the capsule has stopped moving, whether the capsule has been properly inserted, or whether the capsule has been punctured. The capsule housing element 6, located at the upper central outer side, has a volume section 6.3 together with a capsule chamber 6.1 in which the user places the capsule, and within this chamber 6.1 the capsule is punctured. Within the volume section 6.3, the capsule is drawn in by an airflow from the chamber 6.1 onto the capsule and rotates in a rotating chamber 4.2 provided at the base 4 of the mouthpiece 2 to release the therapeutic substance 10. However, within the inner bottom of the capsule housing element 6, one of the long sides of the capsule chamber 6.1 is adjacent to the pressure drop chamber 6.2 and communicates with the volume section 6.3 through an opening 6.6 into which a portion of the electronic circuit board 11, including a pressure sensor 11.1, is inserted from below.

[0039] The pressure sensor 11.1 allows the user to measure the drug administration strength and time. By measuring pressure in correspondence with time, the inspiratory duration and inspiratory force can be determined while the user is taking the drug.

[0040] Each of the two opposing walls has a capsule housing element 6 with two openings: an opening 6.4 for the puncture element and an opening 6.5 at the bottom for the mandrel. The puncture element 7.1, such as a needle, is placed inside the opening 6.4. The puncture element 7.1 is part of the puncture mechanism and is fixed to a push button 7 on the mandrel 7.2. The mandrel 7.2 is placed inside the opening 6.5 for the mandrel, and this mandrel is also fixed to the push button 7. The mandrel 7.2 is equipped with a spring 9, which stabilizes the movement of the push button 7. This ensures that when the push button 7 is pressed, it does not deviate from its longitudinal axis, and the puncture element 7.1 always enters the capsule chamber 6.1 through the opening 6.4 in the same orientation, resulting in reproducible capsule puncture and therefore reproducible efficacy of drug release. Furthermore, a magnet 8 is provided on the push button 7 at the bottom of the mandrel 7.2. The push button 7 is positioned at the same height as the capsule housing element 6.

[0041] The inhaler has two push buttons 7 coupled to the body 14 and cover 5 via upper and lower catches. A frame 13 is placed inside the body 14 and is detachably coupled to the body 14 by two connecting elements 15, such as screws or bolts. The frame 13 allows for the precise positioning of the pressure sensor 11.1 relative to a specially designed pressure drop chamber 6.2, as shown in Figure 13. The frame 13 provides stabilization and smooth movement of the push buttons 7 and joins all components together. In one embodiment, an electronic circuit board 11 including a microprocessor 11.4 and a battery (or rechargeable battery) 12 are located inside the frame 13. In another embodiment, the electronic circuit board 11 is housed within a suitably profiled body 14.

[0042] The electronic circuit board 11 has, on its side, two magnetic field sensors 11.2, for example, Hall effect devices, and a light indicator 11.3, for example, an LED, each positioned in close proximity to the push button 7. Furthermore, the sensors 11.2 are positioned in close proximity to the magnet so that they can respond to the movement of the magnet 8 moving on the magnetic field sensors 11.2, thereby enabling the recording of the speed and depth at which each of the puncture elements 7.1 is pressed.

[0043] In addition, the electronic circuit board 11 also includes a switch 11.12, which is a base opening sensor 4, connected to the base 4 of the mouthpiece 2 via a coupling element 10, such as a push part, passing through an opening in the upper surface of the cover 5, with its surface adjacent to the base 4 of the mouthpiece 2. The inhaler is operated by opening the base 4 of the mouthpiece 2. The status of the push part is mechanically changed by opening the base 4 of the mouthpiece 2. Detection that the base 4 of the mouthpiece is open is recorded by the switch 11.12 and indicates the start of the inhalation process.

[0044] In another embodiment, a position sensor 11.10, such as a 3-axis accelerometer, is placed on an electronic circuit board 11 coupled to a microprocessor 11.4, which allows for verification of whether inhalation was performed properly by verifying whether the inhaler is maintained in the correct position during inhalation, i.e., whether it has an inclination angle of 15°, within the range of 10° to 20° + / - 2° relative to the horizontal.

[0045] In a further embodiment, an antenna 11.5, for example, a Bluetooth antenna, is mounted on an electronic circuit board 11 coupled to a microprocessor 11.4. (Registered trademark) An antenna is positioned to enable wireless communication between the inhaler and a user device, such as a smartphone. The smartphone may also have an appropriate application installed, the main functions of which may include: - Educational module - device operation, suction force and duration, device tilt angle; - Inhalation history and daily / weekly / monthly statistics; - Countdown to the next inhalation; - The ability to set personalized reminders; - Statistics module; - Pollen map with personalized warning alerts; - An individualized list of administered medications, along with a reminder; - Weather widget - temperature, air quality.

[0046] In one embodiment, for example, a USB-C port is placed on the electronic circuit board 11 coupled to the microprocessor 11.4. (Registered trademark) A connector of type 11.6 is also positioned, which allows for charging of a device powered by battery 12, which is ejected during operation.

[0047] In another embodiment, an on / off switch is located on the electronic circuit board 11 coupled with a microprocessor 11.4, which allows the inhaler to be manually turned on and / or off, for example, when it is necessary to limit power consumption when the inhaler is not in use.

[0048] In a further embodiment, if there is a problem operating the inhaler, the device settings may be reset, which can be done by implementing a reset element 11.7 on the electronic circuit board 11, for example, a reset switch 11.4 connected to a microprocessor.

[0049] In another embodiment, a real-time clock 11.8 is located on an electronic circuit board 11 coupled to a microprocessor 11.4, allowing for the recording of the exact time a measurement was taken during autonomous operation of the device without pairing with a mobile application.

[0050] In another embodiment, the inhaler on the electronic circuit board 11 coupled to the microprocessor 11.4 has an audio indicator 11.11 along with a light indicator 11.3, which sends a corresponding warning to the user when an error occurs at each step of the inhalation process.

[0051] In further embodiments, the inhaler includes a replaceable sieve 3 that allows for the individualization of the inhaler for drugs administered to a particular user. For example, the sieve 3 shown in Figure 7 may have a mesh with rectangular openings having a width a of 0.97 mm ± 0.03 mm, a height b of 1.00 mm ± 0.03 mm, and an opening spacing X of 0.5 mm ± 0.03 mm.

[0052] In another embodiment, the sieve 3 shown in Figure 8 includes a mesh having rectangular openings with a width c of 0.7 mm ± 0.02 mm, a height d of 1.1 mm ± 0.03 mm, and an opening spacing Y of 1.4 mm ± 0.03 mm.

[0053] In a further embodiment, the sieve 3 shown in Figure 9 includes a mesh having rectangular openings with a width c of 1.11 mm ± 0.03 mm, a height d of 1.1 mm ± 0.03 mm, and an opening spacing Z of 0.93 mm ± 0.03 mm.

[0054] In another embodiment, the inhaler has a replaceable mouthpiece 2 in which the clearance of the inner diameter of the mouthpiece 2 is reduced, as shown in Figure 4a.

[0055] In a further embodiment, the inhaler has a replaceable mouthpiece 2 in which the clearance of the inner diameter of the mouthpiece 2 is constant, as shown in Figure 4b.

[0056] In further embodiments, the electronic circuit board 11 of the inhaler shown in Figures 15 and 16 includes a microprocessor having a BLE wireless module such as a CC2650F128RGZR, which is connected to the following: - Pressure sensor 11.1, e.g., BMP280; - Switch 11.2, e.g., SKRTLAE010; - Position sensor 11.10, e.g., MPU6050; - Left and right magnetic field sensors 11.2, e.g., 634-SI7210-B-00-IV and 634-SI7210-B-03-IV; - Left and right light indicator 11.3, for example, KPFA-3010RGBC-11; - Voice indicator 11.11, for example, SMT-1640-S-2-R; - Any on / off switch, e.g., for transmitting RGB LED signals; - Memory 11.9, such as EEPROM AT24CM02, to allow the inhaler to record several complete operating cycles.

[0057] Furthermore, in one embodiment, the microprocessor 11.4 has a power supply unit as shown in Figure 15, comprising a 2.8V voltage stabilizer (e.g., TC1015-2.8), a 3.7V minimum 380mAh LiPo battery, a voltage divider, and a connector 11.6 (e.g., USB-C). (Registered trademark) Includes a 3.7V battery charging unit (e.g., LTC4054) coupled to a socket.

[0058] Users who wish to perform inhalation using the inhaler according to the present invention must first prepare the device for use by ensuring that the device is charged. A flashing blue light indicates that the device is ready for use and is not linked to a smartphone. Before first use, the user decides whether or not to monitor the regularity of the inhalation being performed using a specially designed application. This application also includes an educational module aimed at training the user on the proper execution of the treatment process (inhalation).

[0059] If a user wishes to operate the inhaler using the application, the user must first download the application to their smartphone. The user installs the application on their smartphone. Before launching the application, the user must connect their smartphone via Bluetooth. (Registered trademark) Activate the module and pair it with the device. During application installation, the user configures the application according to the user guide.

[0060] Having prepared the inhaler in this way, the user activates the application, finds the blister pack containing the drug capsule, and begins the inhalation process. The user holds the inhaler in one hand and grasps the device housing 1 with the other hand, or lifts the projection 4.1 (Figure 6) located on the base 4 of the mouthpiece 2 with their thumb to open the device. The modular mouthpiece unit, comprising the mouthpiece 2 (Figure 4), the sieve 3 (Figures 7-9), the base 4 of the mouthpiece 2 (Figures 5 and 6), and the housing 1 (Figure 3), opens upward and pivots backward from the device. Opening the device releases pressure on the coupling element 10 (Figure 2). The movement resulting from the release of the coupling element 10 also releases pressure on the switch 11.12 (Figure 16b). The switch 11.12 is part of the electronic equipment that controls the inhaler. The switch 11.12 is located on the electronic circuit board 11 (Figures 2 and 16) and is located within the body 14 of the inhaler (Figure 14). The electronic circuit board 11 may be, for example, a PCB made using four-layer technology with components on both sides (Figure 16).

[0061] The coupling element 10 releases pressure to the switch 11.12, triggering the generation of a signal read by software that controls the inhaler's operation as "device open". When the "device open" information is generated, an electrical element transmits a signal, causing a diode 11.3 located on the same circuit board 11 to emit a light signal. The diode 11.3 begins flashing green the moment the inhaler is activated. Simultaneously, the Bluetooth antenna 11.5 also functions. (Registered trademark) Using the module, a microprocessor 11.4 located on the electronic circuit board 11 sends a signal to the user's smartphone. The application screen displays the message, "Insert the capsule and close the device." At this point, the user removes the capsule from the blister and places it in the special capsule chamber 6.1 located within the capsule housing element 6 (Figure 11). Once this operation is complete, the user closes the inhaler. The module mouthpiece system, comprising the mouthpiece 2 (Figure 4), sieve 3 (Figures 7-9), and the base 4 of the mouthpiece 2 (Figures 5 and 6), as well as the housing 1 (Figure 3), closes downwards, rotating the front of the device. After opening the device, if the user does not perform any operations, the device returns to standby mode after approximately 3 minutes.

[0062] After the capsule is positioned and the device is closed, the user grasps the device by cupping it in their hands. The application screen displays the following message: "Keep the device upright and press and release the push button on the side. The green light indicates that the capsule has been properly punctured." The back of the inhaler defines a hinge 5.1 located on the cover 5 (Figure 10). Because the back of the inhaler is cupped in the user's palm, the user may use their index finger and thumb to simultaneously press the push buttons 7 located on both sides of the device (Figure 12). Regardless of whether the capsule is actually positioned in the capsule chamber 6.1 before the push buttons 7 are pressed, the user may raise the device at eye level and in their position while looking through the capsule housing element 6 (Figure 11). If so, the user keeps the inhaler upright and simultaneously presses the push buttons 7. The needle 7.1 is positioned on the push button 7 (Figure 2) by the sliding motion of the push button 7, which is made possible by the use of a spring 9, and punctures the capsule. A magnet 8 is attached to the push button 7 (Figure 12). The electronic circuit board 11 has two Hall effect sensors, "Hall effect devices" 11.2, on its side that respond to the movement of the magnet 8. The signals transmitted by the Hall effect devices 11.2 generate numerical signals. When a threshold is exceeded, the installed microprocessor or mobile application approves the process, which is indicated to the user by the activation of a green light. If for any reason the appropriate signal value is not reached, the diode 11.3 turns purple, and the application displays the following message: "The purple light indicates that the capsule was not properly punctured. Replace the capsule and start inhalation again."

[0063] If the user properly inserts the capsule, the spring 9 releases the push button 7, returning it to its initial position. The signal generated by the Hall effect device 11.2, caused by the movement of the magnet 8, returns to its initial state, and the user receives the following information from the application: "Remove the cap before inhaling and take a shallow breath outside the inhaler. Then, place the mouthpiece of the inhaler into your mouth." The device illuminates a green light, indicating that it is ready for the subsequent process. When the housing 1 (Figure 2) is removed, the user clicks "Next" in the application. The user receives the following message: "Find the correct angle for the inhaler. Be sure to maintain an upright position."

[0064] The user moves the inhaler to a vertical position. Before the user inhales, the device needs to be set to the correct angle. An accelerometer 11.10 located on the electronic circuit board 11 makes it possible to set the correct angle. As the device's angle changes, software controlling the device or mobile application monitors its position in XYZ coordinates. While searching for the correct angle, the diode 11.3 is off. However, once the correct angle is set, it begins to light up green. Furthermore, the inhaler communicates that the correct angle has been reached by a single audio signal. The application displays the message "Maintain the correct posture and take a deep breath," and two arrowheads appear on the left and right sides of the screen. When the device reaches the correct angle, the arrowheads on the screen merge into a single line and change color to green. In addition to the light signaling, the application also generates a single audio signal. This is possible by using an audio indicator 11.11 located on the electronic circuit board 11. When the user hears the audio signal, they inhale, insert the inhaler mouthpiece 2 into their mouth, and bite down firmly on it. The user inhales strongly, and in some cases quickly. By using a pressure sensor 11.1 located on the electronic circuit board 11, the device may monitor the pressure drop within the inhaler.

[0065] The pressure drop dP corresponding to the type of inhaler used affects the flow rate of air Q caused by the user's inhalation. During inhalation, the pressure drop causes air to flow. The air is drawn into the device through two inlet channels 4.3. The air reaches a rotating chamber 4.2 located at the base 4 of the mouthpiece 2. The air generates a vortex and simultaneously creates a negative pressure that draws the punctured capsule from the capsule chamber 6.1. The capsule rotates, releasing the drug through the opening created by the puncture. The drug consists of two types of particles: fine particles of the therapeutic substance and coarse particles of the carrier. These two types of particles are bonded together during the drug manufacturing process under mechanical force, not chemical bond. As a result of drawing in the aggregates from the capsule and circulating air, the aggregates separate into two fractions: a fine fraction and a coarse fraction. The effectiveness of deaggregation of the drug structure is determined by whether the user can draw in an appropriate amount of air. As a result, an aerosol, i.e., a mixture of air, the therapeutic substance, and the carrier particles suspended therein, is produced. During user inhalation, the aerosol reaches the upper airway. Effective deagglutination increases the likelihood that the particulate fraction containing the therapeutic substance will reach the lower part of the airway and be "absorbed" by the bronchioles. Obtaining adequate airflow is a prerequisite for a higher probability of delivering an appropriate therapeutic dose. By using an equation that determines the relationship between pressure drop and airflow, the optimal range of pressure drop to be obtained, which is necessary to enable a high probability of delivering an appropriate therapeutic dose, is determined. A pressure sensor 11.1 positioned on the electronic substrate 11 is inserted into a specially designed pressure drop chamber 6.2 adjacent to the capsule chamber 6.1 during device assembly, and the pressure drop chamber 6.2 communicates with a volume section 6.3 via an opening 6.6. The volume section is located above the capsule housing element 6 together with the capsule chamber 6.1.

[0066] The user inhales. The device illuminates a green light until a pressure change is indicated. Diode 11.3 flashes green. At this point, the user must hold their breath for 5 seconds. Diode 11.3 continues flashing until more than 5 seconds have elapsed. The application counts down 5 seconds. When the minimum value of 5 seconds is reached, the device illuminates a green light. The application displays the message: "Have you held your breath for 5 seconds?"

[0067] The user exhales. When the user confirms or denies holding their breath, the application displays the message, "Have you removed the tablet?". The user opens the inhaler as before. When coupling element 10 is released, a signal is generated to the device and the application. The user cleans and closes the inhaler. Upon confirmation, the user receives an inhalation process report. When the user clicks "Next", they receive a message confirming that the inhalation is complete and indicating the time for the next inhalation. When the "Finish" button is pressed, two audio signals are generated and a green light illuminates on the inhaler button. After 3 seconds, the device enters standby mode.

[0068] All terms used throughout this specification, such as “upper” and “lower,” are provided as examples only and are not intended to limit the positioning or configuration of the inhaler elements.

[0069] The embodiments described herein are merely non-limiting instructions relating to the present invention and do not in any way limit the scope of protection as defined by the claims. It should be understood that each technical solution used in an inhaler according to the present invention can be implemented by equivalent techniques without exceeding the scope of protection.

Claims

1. A capsule inhaler for administering a single dose of dry powder from a capsule, the inhaler comprising: a body (14); a mouthpiece (2) including a sieve (3) and a mouthpiece (2) base (4); a cover (5) having an opening and coupled to the body (14); a capsule housing element (6); and at least one push button (7) having a capsule puncture mechanism comprising at least one spring (9) and at least one puncture element (7.1), An electronic circuit board (11) having a microprocessor (11.4) is disposed inside the main body (14), and the electronic circuit board (11) includes at least one magnetic field sensor (11.2) configured to magnetically record the speed and depth at which the puncture element (7.1) is pressed, and at least one optical indicator (11.3) configured to optically communicate a warning to the user of the inhaler when an error occurs in the inhaler, and is positioned adjacent to at least one push button (7) having at least one puncture element (7.1) and at least one magnet (8), and the magnet (8) An inhaler characterized in that, the magnetic field sensor (11.2) is positioned on the same side as the puncture element (7.1) on the push button (7) and adjacent to the magnet (8), while the electronic circuit board (11) is mechanically connected to the base (4) of the mouthpiece (2) via a push portion (10), the electronic circuit board (11) includes at least one pressure sensor (11.1) for measuring pressure changes due to breathing, and the electronic circuit board (11) includes a real-time clock (11.8) for recording the exact time when the pressure measurement was performed by the pressure sensor (11.1).

2. The inhaler according to claim 1, characterized in that the magnetic field sensor (11.2) is a Hall effect device.

3. The inhaler according to claim 1 or claim 2, characterized in that the light indicator (11.3) is a diode.

4. The inhaler according to any one of claims 1 to 3, characterized in that the electronic circuit board (11) is equipped with a switch (11.12) that is mechanically connected to the base (4) via the push portion (10).

5. The inhaler according to any one of claims 1 to 4, characterized in that the electronic circuit board (11) is arranged within a frame (13) housed in the main body (14).

6. The inhaler according to any one of claims 1 to 5, characterized in that the capsule housing element (6) includes a pressure drop chamber (6.2) and a capsule chamber (6.1), and the pressure sensor (11.1) is positioned on the electronic substrate (11) in the pressure drop chamber (6.2) adjacent to the capsule chamber (6.1) at the lower part of the capsule housing element (6).

7. The inhaler according to any one of claims 1 to 6, characterized in that the electronic circuit board (11) is coupled to the microprocessor (11.4), and the angular position sensor (11.10) is arranged on the electronic circuit board (11).

8. The inhaler according to claim 7, characterized in that the angular position sensor (11.10) is an accelerometer.

9. The inhaler according to any one of claims 1 to 8, characterized in that the electronic circuit board (11) is coupled to the microprocessor (11.4), and an antenna (11.5) is arranged on the electronic circuit board (11).

10. The inhaler according to claim 9, characterized in that the antenna (11.5) is a Bluetooth® antenna.

11. The inhaler according to any one of claims 1 to 9, characterized in that the electronic circuit board (11) is coupled to the microprocessor (11.4), and a connector (11.6) is arranged on the electronic circuit board (11).

12. The inhaler according to claim 11, characterized in that the connector (11.6) is a USB-C (registered trademark) type connector.

13. The inhaler according to any one of claims 1 to 12, characterized in that the electronic circuit board (11) is coupled to the microprocessor (11.4), and an on / off switch is arranged on the electronic circuit board (11).

14. The inhaler according to any one of claims 1 to 13, characterized in that the electronic circuit board (11) is coupled to the microprocessor (11.4), and a reset element (11.7) for resetting the settings of the inhaler is arranged on the electronic circuit board (11).

15. The inhaler according to claim 14, characterized in that the reset element (11.7) is a reset switch.

16. The inhaler according to any one of claims 1 to 15, characterized in that the electronic circuit board (11) is coupled to the microprocessor (11.4), and the real-time clock (11.8) is arranged on the electronic circuit board (11).

17. The inhaler according to any one of claims 1 to 16, characterized in that the electronic circuit board (11) is coupled to the microprocessor (11.4), and an audio indicator (11.11) is arranged on the electronic circuit board (11).

18. The inhaler according to any one of claims 1 to 17, characterized in that a frame (13) is placed inside the main body (14), and a battery (12) is arranged inside the frame (13).

19. The inhaler according to any one of claims 1 to 18, characterized in that the main body (14) is detachably coupled to the frame (13) by at least one connecting element (15).

20. The inhaler according to claim 19, characterized in that the connecting element (15) is a screw or a bolt.

21. The inhaler according to any one of claims 1 to 20, characterized in that a housing (1) is positioned on the main body (14) and the cover (5) to surround and cover the mouthpiece (2) and the base (4).

22. The inhaler according to any one of claims 1 to 21, characterized in that the sieve (3) comprises a mesh having rectangular openings with a width (a) of 0.94 to 1 cm, a height (b) of 0.97 to 1.03 cm, and an opening spacing (X) of 0.47 to 0.53 cm.

23. The inhaler according to any one of claims 1 to 21, characterized in that the sieve (3) comprises a mesh having rectangular openings with a width (c) of 0.68 to 0.72 cm, a height (d) of 1.07 to 1.13 cm, and an opening spacing (Y) of 1.37 to 1.43 cm.

24. The inhaler according to any one of claims 1 to 21, characterized in that the sieve (3) comprises a mesh having rectangular openings with a width (e) of 1.08 to 1.14 cm, a height (f) of 1.07 to 1.13 cm, and an opening spacing (Z) of 0.90 to 0.96 cm.

25. The inhaler according to claim 1, characterized in that a projection (4.1) for lifting the base (4) is arranged on the base (4).

26. The inhaler according to claim 1, characterized in that the base (4) of the mouthpiece (2) is hinged to the cover (5).

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