• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    Dose measurement device and method in dry powder inhalers. The dose measuring device for a dry powder inhaler comprises an inhalation mouthpiece (3) that can be coupled to the free end of the mouthpiece (13) of a dry powder inhaler (10), where the inhalation mouthpiece (3) comprises a conduit (35) for the passage of inhaled air (39); a dust sensor (4) configured to measure the density of solid particles suspended in air inside the conduit (35) of the inhalation mouthpiece (3); a barometric pressure sensor (5) for measuring the air pressure inside the inhalation mouthpiece (3); a control unit (6) configured to: detect an inhalation produced at the inhalation mouthpiece (3) by analyzing the air pressure at the inhalation mouthpiece (3); calculating, using the reading of the dust sensor (4), a dose of solid particles suspended in the inhaled air (39) that passes through the passage (35) of the inhalation mouthpiece (3) in the detected inhalation. (Machine-translation by Google Translate, not legally binding)
    公开号:ES2807698A1
    申请号:ES201930752
    申请日:2019-08-23
    公开日:2021-02-23
    发明作者:Fernández Alberto Calvo；Gorgojo Ignacio Esteban；Galarza Eduardo Laguna
    申请人:Igncyerto S L；
    IPC主号:
    专利说明:

    [0004] Field of the invention
    [0005] The invention falls within the field of biotechnology and smart devices. In this case, the designed device will complement the use of dry powder inhalers.
    [0006] Background of the invention
    [0007] A dry powder inhaler is a medical device that delivers a drug in the form of powder particles to the patient through the lungs, by inhalation. The dry powder inhaler is used primarily for the treatment of asthma and chronic obstructive pulmonary disease (COPD).
    [0009] Today, less than 30% of patients with asthma or COPD have good adherence to treatment according to the scientific literature. In addition to the lack of adherence, it is known that these devices are complex to use, so there are errors in the inhalation technique, but there is no validated tool for their measurement, so no valid estimate has been made of their percentage of existence. Furthermore, these errors are unconscious, so they are not reported by the patient and can only be detected by observation. This situation implies that good compliance with treatment is frankly less than 30%, because of the patients who report good adherence, there will be an unquantified part that performs inhalation with poor techniques, rendering the treatment useless or greatly reducing the effectiveness of the treatment.
    [0011] This situation makes lack of adherence and errors in the technique of implementation the main cause of poor control in lung diseases. In order for doctors to be able to correctly follow up on treatment, it is necessary to detect the intentional group, where patients do not take medication on purpose. But it is also important to detect the occurrence of the two unintended scenarios, which are involuntary forgetting and the aforementioned errors in technique. Once the 3 causes of non-compliance are taken into account and measured, it is when you can begin to obtain real information on the management of the disease and its true impact.
    [0012] The present invention solves this problem, making it possible to avoid inadvertent lack of adherence to inhalation treatments and bring the intentional lack of adherence to the surface. Optimizing adherence to inhaled medication leads to better control of lung diseases, with asymptomatic patients who will not have to visit an emergency department or be admitted to the hospital, and who will not have limitations in their activities of daily living.
    [0014] Description of the invention
    [0015] The invention relates to an electronic device and a method for measuring doses in dry powder inhalers, which is capable of measuring adherence to an inhalation treatment and the amount of medication inhaled.
    [0017] The device is attached to a dry powder inhaler, adapting to the structure and shape of said inhaler. Once attached, the device allows the number of actual inhaled doses to be counted, which may differ from the doses indicated on the dose indicator of the inhaler itself. In addition, the device quantifies the actual inhaled dose.
    [0019] Therefore, the function of the device is to ensure that the patient inhales the dose of medication by activating the dry powder inhaler and measuring the inhaled dose. According to one embodiment, the device comprises the following elements:
    [0020] • Plastic housing adaptable to each device that houses electronic elements and / or modules and adapts to each inhaler.
    [0022] • Inhalation mouthpiece that attaches to the free end of the mouthpiece of a dry powder inhaler.
    [0024] • Control unit (implemented for example on a PCB) to manage the different components and store data.
    [0026] • Dust sensor located on the inhalation mouthpiece to measure the inhaled medicine dose.
    [0028] • Barometric pressure sensor: A digital barometer that measures the air pressure at the inhalation mouthpiece. The detection of depression generated by the inhalation of the user is used as the activation signal of the control unit. The device can correlate the inhaled dose with the user's capacity, measured as depression through the digital barometer.
    [0029] • DC / DC converter: voltage raising and / or reducing device to provide the necessary operating voltage for the rest of the electronic elements.
    [0031] • Bluetooth micromodule for wireless communication with external devices (smartphones, computers, etc.).
    [0033] To measure inhalation, the device consists of an optical dust sensor mounted on an inhalation mouthpiece that continues to the original outlet of the inhaler. This nozzle, with nozzle geometry, mounts an infrared LED and a serial receiver with a signal amplifier which generates a pulse pattern based on periodically checking the output voltage, for example every 10 ms. This output pattern is interpreted by an algorithm programmed into the device's motherboard. The inhalation reading is activated when a preset pressure variation is detected at the mouthpiece, using the signal from the digital barometer. The powder sensor measures the passage of medicine through the inhalation mouthpiece and allows the control unit to estimate the actual amount inhaled.
    [0035] The barometric pressure sensor is used to distinguish whether the user has actually taken an inhalation or has dropped the medication after pressing the button on the dry powder inhaler, by detecting the depression generated by the user's inhalation. Furthermore, this detected pressure signal is used as an activation signal for other electronic components (e.g., to activate the dust sensor and control unit), thereby saving energy. The digital barometer allows to discriminate if the user is falsifying or not taking the dose.
    [0037] The device can be connected via a wireless communication module, preferably via Bluetooth, with external devices, such as mobile devices (tablets, smartphones, etc.) and computers. Through a software application installed in said device, the history of inhalations made and the history of inhaled doses can be recorded, as well as other additional data such as location, weather, etc.
    [0039] The device of the present invention can detect when inhalation has occurred and, if the measured inhaled quantity is insufficient, alert the patient (for example, through the app of their smartphone connected to the device) of a poor quality in their breathing technique. inhalation. In this way, the app can recommend the patient to visit their doctor, nurse or trainer to improve their inhalation technique. The app can also remind the patient if he is missing a dose, reinforcing the patient's adherence to the inhalation treatment established by the doctor. The history of monitoring of inhalations carried out and inhaled doses of medicine allows the doctor to determine in the periodic reviews if the follow-up of the treatment is correct, and even to discover voluntary lack of adherence by the patient (in the case, for example, that the detected inhalations do not coincide by a wide margin with the dose indicator on the inhaler itself). In addition, using the information captured by the device, doctors can objectify the adherence, the technique and the deposit of drugs in the lungs, to be able to differentiate if poor asthma control is due to poor adherence or an insufficient dose, thus improving this form the treatment to follow.
    [0041] Furthermore, as the device allows monitoring of treatment follow-up, patients who intentionally avoid taking their medications are encouraged to undergo treatment to avoid the embarrassment of acknowledging, during regular review with their physician, that they have not followed medical advice. In the event that the patient intentionally maintains their lack of adherence to treatment, the device detects this situation, allowing doctors to avoid an overdose or expose patients to unnecessary treatments such as biologics.
    [0043] In this way, the device of the present invention makes it possible to improve adherence to inhalation treatments in diseases such as asthma and chronic obstructive pulmonary disease.
    [0045] Brief description of the drawings
    [0046] A series of drawings that help to better understand the invention and that expressly relate to an embodiment of said invention that is presented as a non-limiting example of this, will now be described very briefly.
    [0048] Figure 1 shows a dry powder inhaler of the state of the art, to which the device of the present invention can be attached.
    [0050] Figures 2A-2E depict various views of a dose measuring device for a dry powder inhaler according to an embodiment of the present invention.
    [0052] Figure 3 illustrates a dose measuring device according to the present invention attached to a dry powder inhaler.
    [0054] Figures 4A and 4B show various views of the front of the inhalation mouthpiece.
    [0056] Figure 5 illustrates a perspective view of the dose measuring device where the components of the dust sensor installed inside the inhalation mouthpiece can be seen.
    [0058] Figure 6 shows a diagram of the electronic components of the dose measuring device, and its wireless connection with an external mobile device.
    [0060] Figures 7A, 7B and 7C illustrate, respectively, a side view (Fig. 7A), a front view (Fig. 7B) and a perspective view (Fig. 7B) of a dry powder inhaler that incorporates the sensor at the factory. powder and the barometric sensor on the mouthpiece of the inhaler.
    [0062] Figure 8 shows a diagram of the electronic components of the dry powder inhaler of Figure 7, and its wireless connection with an external mobile device.
    [0064] Figure 9 illustrates a flow chart of a dose measurement method according to the present invention.
    [0066] Figure 10 includes a flow chart detailing how the solid particle dose calculation is performed, according to a possible embodiment.
    [0068] Detailed description of the invention
    [0069] The present invention relates to a dose measuring device for a dry powder inhaler. Figure 1 represents, by way of example, a dry powder inhaler 10 of the state of the art to which the device 1 of the present invention is directed. Typical operation of a dry powder inhaler 10 by a user includes the following steps:
    [0070] - Remove the cap from the inhaler 11.
    [0071] - Shake the inhaler and press the button 12 located on the upper part of the inhaler when it is in the vertical position.
    [0072] - Place the mouthpiece of the inhaler 13 between the lips and the teeth and breathe in forcefully and deeply until the inhaled air circulates through the hole 14 from the mouthpiece and fill the lungs. In dry powder inhalers 10, it is the patient himself with his inspiration that generates the current to transport the medicine.
    [0074] Figures 2A-2E respectively show a perspective view, a front view, a profile view, a top view and a rear view of the dose measuring device 1 for dry powder inhaler according to a possible embodiment. The dose measuring device 1 is prepared to be coupled to a dry powder inhaler 10, as for example the one represented in Figure 1. In Figure 3 a dose measuring device 1 is represented (in this case corresponding to another possible embodiment with slight changes in the shape of the housing 2 and in the fastening means) already coupled to a dry powder inhaler 10.
    [0076] The dose measuring device 1 comprises an inhalation mouthpiece 3 which is attached, for example by pressure or using clamping means, to the free end of the mouthpiece 23 of a dry powder inhaler 10, as shown in the example of Figure 3. This inhalation mouthpiece 3 will be the one that will contact, at least at one of its ends, with the user's mouth at the moment of inhalation. The inhaled air passes into the mouth of the user through a first air passage hole 30 made in the front part of the inhalation mouthpiece 3. Said first inhaled air passage hole 30 preferably has a size and position such that, once attached to the mouthpiece of the inhaler 13, it coincides at least partially (in front view) with the orifice 14 of the mouthpiece of the inhaler 13 to facilitate the circulation of the inspired air.
    [0078] Figures 4A and 4B respectively illustrate a perspective view and a front end view of the inhalation mouthpiece 3 in which a front cover 31 has been removed to allow a detailed view of the interior of the mouthpiece. The air inhaled 39 by the user, in which a dose of medicine flows from the dry powder inhaler 10, exits the hole 14 of the inhaler mouthpiece 13, enters the interior of the inhalation mouthpiece 3 through a second hole 36 practiced in its rear part (which is at least partially coincident with the hole 14 of the inhaler mouthpiece 13), circulates through a conduit 35 inside the inhalation mouthpiece 3 and exits through the first hole 30 passage of inhaled air practiced in the front part of the inhalation mouthpiece 3. To ensure that all the inhaled air 39 circulating through the duct 35 passes through the hole 30, the duct 35 is preferably in contact with the first hole 30 , of so that the first hole 30 could be considered as the front end of the conduit 35 or as a continuation of the conduit 35 with the same or different area or section. In a possible embodiment the duct 35 could have a very reduced thickness, coinciding for example with the thickness of the front cover 31 and with the first hole 30. The first 30 and second 36 holes of the inhalation mouthpiece 3 are preferably circular in shape, although they could take other forms. Similarly, the conduit 35 of the inhalation mouthpiece 3 is preferably circular in section, although it can adopt other types of sections (eg, square).
    [0080] The dose measuring device 1 comprises a dust sensor 4 integrated inside the inhalation mouthpiece 3. The dust sensor 4 is configured to detect the presence of solid particles suspended in air inside the mouthpiece duct 35 inhalation 3. Preferably, the dust sensor 4 used is an optical dust sensor. Optical dust sensors comprise an optical emitter and an optical receiver. The optical emitter is preferably a light emitting diode in the infrared spectrum (infrared LED or IRED). The optical receiver can be a photodiode or a phototransistor, which detects infrared light reflected by dust or solid particles suspended in air. By reading the dust sensor 4 the density of dust in the inspired air flow can be calculated.
    [0082] According to the embodiment shown in Figures 4 and 5 , the optical emitter 40 of the dust sensor 4 is located externally to the duct 35, next to a first opening 37 made therein, which allows the passage of the light beam, preferably infrared, coming from the optical emitter 40. Similarly, the optical receiver 41 of the dust sensor 4 is arranged adjacent to a second opening 38 made in the conduit 35, which allows the reception of the infrared light beam reflected by the dust or solid particles (ie the medicine from the dry powder inhaler 10) suspended in the inhaled air 39 that circulates through the conduit 35. The openings (37, 38) are located in the conduit 35 preferably facing each other (in the example of the Figure the vectors perpendicular to the openings at their midpoints focus on the same point of the longitudinal axis of the duct 35, to obtain a better reading).
    [0084] The dose measuring device 1 also comprises a barometric pressure sensor 5 integrated in the inhalation mouthpiece 3 and configured to measure the air pressure inside the inhalation mouthpiece 3.
    [0085] In one embodiment, the inhalation mouthpiece 3 only comprises the front end piece shown in Figure 4, which in addition to housing the dust sensor 4 would also include the barometric pressure sensor 5. In the embodiment shown in Figures 2 and 3, the inhalation mouthpiece 3 comprises, in addition to the front piece shown in Figure 4, a hollow lower piece 32 that is coupled to said front piece. Alternatively, the front piece and the bottom piece are formed in one piece.
    [0087] According to one embodiment, the barometric pressure sensor 5 is housed in the lower part of the inhalation mouthpiece 3 (housed for example in the lower part 32, as shown with a broken line in Figure 3), which It is hollow and allows, in addition to housing said sensor, the wiring passage 42 to connect the dust sensor 4 with a control unit 6 housed in a housing 2 of the dose measuring device 1 (in this case, the wiring 42 of the dust sensor 4 would pass through an opening 43 below a back plate 44 containing the second hole 36 of the front part of the inhalation mouthpiece 3).
    [0089] The barometric pressure sensor 5 is housed inside the inhalation mouthpiece 3 in contact with the inhaled air 39 flowing through the duct 35. For example, it could be housed in an opening made in the duct 35 itself, in a similar way and how the optical emitter 40 and optical receiver 41 of the dust sensor 4 are housed (Figure 5). In the example of Figure 3, where the barometric pressure sensor 5 is housed in the lower part 32 of the inhalation mouthpiece 3, to measure the pressure of the air circulating inside the duct 35, the duct 35 must not be isolated from the lower part 32; that is, the conduit 35 and the lower part 32 where the barometric pressure sensor 5 is housed must be in air contact, at the same barometric pressure. For this, one or both ends of the conduit 35 may be free, or the conduit 35 may have a hole that allows air contact with the lower hollow part 32. In the example of Figure 4, the rear end of the conduit 35 does not contact the rear plate 44 of the inhalation mouthpiece 3.
    [0091] The dose measuring device 1 comprises a control unit 6 (a circuit or hardware element with electronic control functions, implemented for example by a microcontroller), configured to detect an inhalation produced in the dry powder inhaler 10 by analyzing the air pressure inside the inhalation mouthpiece 3, using the reading from the barometric pressure sensor 5. Once Once inhalation is detected, the control unit 6 is responsible for estimating the dose of solid particles suspended in air that passes through the inhalation mouthpiece 3 in said inhalation, using the reading of the dust sensor 4.
    [0093] The control unit 6 can be housed in the inhalation mouthpiece 3 itself, for example in the lower part 32. Alternatively, the control unit 6 can be housed in a housing 2 attached to the inhalation mouthpiece 3, as shown. shown in Figures 2 and 3. In this case, the control unit 6 can be connected to the optical sensor 40 and the barometric pressure sensor 5 by means of wiring 42 that runs inside the inhalation mouthpiece 3 to the inside of the housing 2.
    [0095] The housing 2 shown in Figures 2 and 3 comprises a base 20 and two side pieces (21, 22) that are prepared to receive and / or house the body 15 of the dry powder inhaler 10 (the body 15 is the part of the inhaler which does not include the nozzle 13 or the button 12). The lower part 32 of the inhalation mouthpiece 3 is connected to the base 20 of the housing 2 and is shaped to accommodate or support, at least partially, the mouthpiece of the inhaler 13. In this way, the dry powder inhaler 10 it can be easily fitted into the dose measuring device 1 by means of a vertical insertion movement. To facilitate the fixing of the dry powder inhaler 10, the dose measuring device 1 may comprise clamping means arranged on the housing 2 and / or on the inhalation mouthpiece 3, such as side rings 33 located on the inhalation mouthpiece. 3 for the introduction of a squeeze tape or rubber, or a fastening strip 34 integral with the inhalation mouthpiece itself 3.
    [0097] The housing 2 can be made in one piece or it can be composed of several individual pieces joined together. The interior of the housing 2 can house different electronic components, among them the control unit 6. Figure 6 represents a block diagram with the electronic components of the dose measuring device 1 according to a possible embodiment. A battery 7 housed in a housing supplies power to the control unit 6, through a DC / DC converter 8 (for example, a 5V boost converter) to ensure a constant and determined voltage level to the control unit 6 The control unit 6 (or alternatively the battery 7 itself) supplies power to the dust sensor 4 and the barometric pressure sensor 5. The battery 7 is preferably of the rechargeable type, being able to charge through a connector of load 25 located at the rear of the case (Figure 2E). The device may include a battery charging circuit.
    [0099] A wireless communication module 9 (implemented for example by a Bluetooth module) allows remote connection to a control station (eg, a computer) or a mobile device 50 (eg, a smartphone) for the transmission of calculated information and / or collected by the control unit 6. For example, the control unit 6 can store in an internal memory a history of inhalations carried out and measurements of inhaled doses, which are transmitted through the Bluetooth module to an application of a mobile device 50 connected via Bluetooth.
    [0101] The dose measurement device 1 and mobile device 50 can form a dose measurement system 60, where the dose measurement device 1 measures the inhalations performed and the inhaled doses and the mobile device 50 monitors said data and can send notifications and / or alerts 52 informing about compliance or non-compliance with the marked inhalation treatment. Notifications and / or alerts 52 can be communicated locally to the patient or user of the mobile device 50, for example through information or messages displayed on the screen of the mobile device 50, sound messages, acoustic or vibrating alarms, etc. Information regarding compliance or non-compliance with inhalation treatment can also be communicated to a remote device, for example to another mobile device or a computer through an Internet connection, through which other people (family members of the patient, doctor, nurse, etc.) can have access to the data captured by the dose measuring device 1.
    [0103] Alternatively, or additionally, the device can include a memory 16 (such as an EEPROM memory, a flash memory, a microSD card, etc.), which can be incorporated in the control unit itself 6. Through a port of communication 24 (for example, a USB, mini USB or micro USB port) located on the outside of the housing 2 the information stored in the memory 16 can be accessed. memory (eg a microSD card) the device allows you to directly retrieve the memory card, for example by activating a button.
    [0104] To save battery power 7, the control unit 6 (for example a microcontroller) can operate in power saving mode or sleep mode most of the time, and use the pressure signal coming from the barometric pressure sensor 5 to wake the microcontroller from sleep mode, similar to an interrupt. For example, when the pressure signal exceeds a certain threshold, the control unit 6 wakes up from sleep mode (signal 17 in Figure 6).
    [0106] At the moment when the user or patient takes an inhalation, the barometric pressure sensor 5 is activated and measures the pressure difference between the aspiration and the atmospheric one. As the medication passes through the inhalation mouthpiece 3 of the device, the dust sensor 4 detects the passage of particles and provides a reading of the density of the powder in the aspirated flow. The level of the output voltage of the dust sensor 4 determines the density of the dust, according to a graph or function that depends on the particular dust sensor 4 used. For example, a 3V output from a commercial 4 dust sensor can mean a dust density of 0.4 mg / m3.
    [0108] The flow rate of inhaled air Q flowing through the conduit 35 of the inhalation mouthpiece 3 is determined on the basis of the velocity Vd of the fluid through the section of the conduit Sd.
    [0113] The main equation that determines the passing speed Vd of the aspiration is the following:
    [0118] Where C is the discharge coefficient, the material balance constant p is obtained experimentally (the value is between 0.2 and 0.75, being a dimensionless variable that can be initially set to 0.4), and the factor expansion Y is calculated according to the following expression:
    [0120] Y = 1 - Pa ~ Pd (0.41 0.35 / 4)
    [0123] The adiabatic coefficient y can be assumed to be a value of 1.4, based on the following variability range:
    [0128] In the previous equations it can be assumed that Pa is the atmospheric pressure and Pd is the pressure read by the barometric pressure sensor 5. In this way, the passage speed V d of the air flow is characterized, and with it the flow of the fluid. Q.
    [0130] With the combined information of the aspiration flow rate (in m3 / s, obtained continuously during inspiration through the pressure signal of the barometric pressure sensor 5) and the dust density (in mg / m3, obtained at each instant Through the output signal of the dust sensor 4), the mass flow rate of solid particles (in mg / s) circulating through the conduit 35 at each instant is determined. By integrating said mass flow rate during the inhalation period, the mass of solid particles (in mg) inhaled is obtained, which can be converted directly into the dose of active drug principle that the patient has inhaled, depending on the ratio of the active ingredient and excipients of each medicine used in particular.
    [0132] Figures 7A , 7B and 7C represent different views of a dry powder inhaler 70 that already incorporates the powder sensor 4 and the barometric pressure sensor 5 already installed in the mouthpiece 73 of the inhaler.
    [0134] Figure 8 represents a figure equivalent to Figure 6, where basically the dose measuring device 1 has been replaced by the dry powder inhaler 70 of Figure 7. The mobile device 50 and dry powder inhaler 70 can also form , as explained in Figure 6, a dose measurement system 80.
    [0136] A flow chart of a dose measurement method 100 in dry powder inhalers according to the present invention is depicted in Figure 9. The method, which is executed by the dose measuring device 1 (Figs. 2-6) or the dry powder inhaler 70 (Figs. 7-8), comprises the following steps:
    [0137] - Measure the air pressure 102 inside the mouthpiece (3; 73) of a dry powder inhaler (10; 70). The mouthpiece may correspond to the inhalation mouthpiece 3 of the dose measuring device 1 (which attaches to the free end of the mouthpiece 13 of a dry powder inhaler 10), or the mouthpiece 73 of a dry powder inhaler 70 as the one represented in Figure 7.
    [0138] - Detect an inhalation 104 by analyzing the air pressure at the mouthpiece (3; 73).
    [0139] - Measure the density of solid particles suspended in air 106 inside the nozzle (3; 73).
    [0140] - Calculate a dose of solid particles 108 suspended in the inhaled air 39 that passes through the mouthpiece (3; 73) on the detected inhalation.
    [0142] The diagram in Figure 10 details the calculation of the dose of solid particles 108 carried out in the dose measurement method 100. The calculation comprises in particular the following steps:
    [0143] - Determine the density (e.g., in g / m3) of solid particles 110 in the inhaled air 39 during inhalation.
    [0144] - Calculate the volumetric flow (e.g., in m3 / s) of air 112 during inhalation.
    [0145] - Determine the mass flow rate (e.g., in g / s) of solid particles 114 that passes through the mouthpiece (3; 73) during inhalation.
    [0146] - Integrate the mass flow rate 116 over the duration of inhalation, obtaining the inhaled dose (e.g., in g).
    权利要求:
    Claims (29)
    [1]
    1. Dose measuring device for dry powder inhaler, characterized in that it comprises:
    an inhalation mouthpiece (3) attachable to the free end of the mouthpiece (13) of a dry powder inhaler (10), where the inhalation mouthpiece (3) comprises a conduit (35) for the passage of inhaled air (39) ;
    a dust sensor (4) configured to measure the density of solid particles suspended in air inside the conduit (35) of the inhalation mouthpiece (3);
    a barometric pressure sensor (5) for measuring the air pressure inside the inhalation mouthpiece (3);
    a control unit (6) configured to:
    detecting an inhalation produced at the inhalation mouthpiece (3) by analyzing the air pressure in the inhalation mouthpiece (3);
    calculating, using the reading of the dust sensor (4), a dose of solid particles suspended in the inhaled air (39) that passes through the passage (35) of the inhalation mouthpiece (3) in the detected inhalation.
    [2]
    Device according to claim 1, characterized in that for the calculation of the dose of solid particles that passes through the conduit (35) during inhalation, the control unit (6) is configured to:
    - determining, by reading the dust sensor (4), the density of solid particles in the inhaled air (39) during inhalation;
    - calculate the volumetric flow of air during inhalation using the pressure signal from the barometric pressure sensor (5);
    - determining the mass flow rate of solid particles that passes through the conduit (35) during inhalation;
    - integrate the mass flow rate over the duration of inhalation. 3
    [3]
    Device according to any of the preceding claims, characterized in that the control unit (6) is configured to initiate the detection of an inhalation when it detects an air pressure inside the inhalation mouthpiece (3) in a certain range. .
    [4]
    Device according to any of the preceding claims, characterized in that the dust sensor (4) is an optical dust sensor.
    [5]
    Device according to claim 4, characterized in that the dust sensor (4) comprises:
    an optical emitter (40) configured to emit a beam of light into the conduit (35) through a first opening (37) made in the conduit (35); and an optical receiver (41) configured to receive the beam of light reflected by solid particles suspended in air inside the conduit (35) through a second opening (38) made in the conduit (35).
    [6]
    Device according to any of the preceding claims, characterized in that the inhalation mouthpiece (3) comprises a lower hollow part (32) inside which the barometric pressure sensor (5) is located.
    [7]
    Device according to any of the preceding claims, characterized in that it comprises a housing (2) formed by a base (20) and two side pieces (21, 22) prepared to receive the body (15) of a dry powder inhaler ( 10).
    [8]
    Device according to any of the preceding claims, characterized in that it comprises clamping means (33, 34) adapted for fixing the inhalation mouthpiece (3) to a dry powder inhaler (10).
    [9]
    Device according to any of the preceding claims, characterized in that the control unit (6) is configured to store in a memory (16) a history of inhalations carried out and measurements of inhaled doses.
    [10]
    Device according to any of the preceding claims, characterized in that it comprises a wireless communication module (9), and in that the control unit (6) is configured to send wirelessly, through said wireless communication module (9) , a history of inhalations taken and inhaled dose measurements.
    [11]
    11. Dose measurement system in dry powder inhalers, characterized in that it comprises:
    a dose measuring device (1) according to claim 10;
    a mobile device (50) configured to wirelessly receive a history of inhalations performed and inhaled dose measurements.
    [12]
    12. Dose measurement system according to claim 11, characterized in that the mobile device (50) is configured to:
    checking compliance with a predetermined inhalation treatment based on the history of inhalations performed and inhaled dose measurements;
    send at least one notification and / or alert (52) informing about compliance with inhalation treatment.
    [13]
    13. Dry powder inhaler, characterized in that it comprises:
    a mouthpiece (73) with a conduit (35) for the passage of inhaled air (39);
    a dust sensor (4) configured to measure the density of solid particles suspended in air inside the duct (35) of the nozzle (73);
    a barometric pressure sensor (5) for measuring the air pressure inside the nozzle (73);
    a control unit (6) configured to:
    detecting an inhalation by analyzing the air pressure in the mouthpiece (73);
    calculating, using the reading of the dust sensor (4), a dose of solid particles suspended in the inhaled air (39) that passes through the conduit (35) of the mouthpiece (73) in the detected inhalation.
    [14]
    Dry powder inhaler according to claim 13, characterized in that for the calculation of the dose of solid particles that passes through the conduit (35) during inhalation, the control unit (6) is configured to:
    - determining, by reading the dust sensor (4), the density of solid particles in the inhaled air (39) during inhalation;
    - calculate the volumetric flow of air during inhalation using the pressure signal from the barometric pressure sensor (5);
    - determining the mass flow rate of solid particles that passes through the conduit (35) during inhalation;
    - integrate the mass flow rate over the inhalation time.
    [15]
    Dry powder inhaler according to any of claims 13 to 14, characterized in that the control unit (6) is configured to initiate the detection of an inhalation when it detects an air pressure inside the mouthpiece (73) at a certain range.
    [16]
    Dry powder inhaler according to any one of claims 13 to 15, characterized in that the powder sensor (4) is an optical powder sensor.
    [17]
    17. Dry powder inhaler according to claim 16, characterized in that the powder sensor (4) comprises:
    an optical emitter (40) configured to emit a beam of light into the conduit (35) through a first opening (37) made in the conduit (35); Y
    an optical receiver (41) configured to receive the beam of light reflected by solid particles suspended in air inside the conduit (35) through a second opening (38) made in the conduit (35).
    [18]
    Dry powder inhaler according to any one of claims 13 to 17, characterized in that the control unit (6) is configured to store in a memory (16) a history of inhalations carried out and measurements of inhaled doses.
    [19]
    19. Dry powder inhaler according to any of claims 13 to 18, characterized in that it comprises a wireless communication module (9), and in that the control unit (6) is configured to send wirelessly, through said module of wireless communication (9), a history of inhalations performed and inhaled dose measurements.
    [20]
    20. Dose measurement system in dry powder inhalers, characterized in that it comprises:
    a dry powder inhaler (70) according to claim 19;
    a mobile device (50) configured to wirelessly receive a history of inhalations performed and inhaled dose measurements.
    [21]
    21. Dose measurement system according to claim 20, characterized in that the mobile device (50) is configured to:
    checking compliance with a predetermined inhalation treatment based on the history of inhalations performed and inhaled dose measurements;
    send at least one notification and / or alert (52) informing about compliance with inhalation treatment.
    [22]
    22. Dose measurement method in dry powder inhalers, characterized in that it comprises:
    measuring the air pressure (102) inside the mouthpiece (3; 73) of a dry powder inhaler (10; 70);
    detecting an inhalation (104) by analyzing the air pressure in the mouthpiece (3; 73);
    measuring the density of solid particles suspended in air (106) inside the nozzle (3; 73);
    calculating a dose of solid particles (108) suspended in the inhaled air (39) that passes through the mouthpiece (3; 73) on the detected inhalation.
    [23]
    23. Dose measurement method according to claim 22, characterized in that the calculation of the dose of solid particles (108) comprises:
    - determining the density of solid particles (110) in the inhaled air (39) during inhalation;
    - calculate the volumetric flow of air (112) during inhalation;
    - determining the mass flow rate of solid particles (114) passing through the mouthpiece (3; 73) during inhalation;
    - integrate the mass flow rate (116) in the time that inhalation lasts.
    [24]
    24. Dose measurement method according to any of claims 22 to 23, characterized in that the measurement of the density of solid particles is carried out using a dust sensor (4) integrated inside the nozzle (3; 73).
    [25]
    25. Dose measurement method according to any of claims 22 to 24, characterized in that the air pressure measurement is performed using a barometric pressure sensor (5) integrated inside the nozzle (3; 73).
    [26]
    26. Dose measurement method according to any of claims 22 to 25, characterized in that the stage of detecting an inhalation starts when an air pressure is detected inside the mouthpiece (3; 73) in a certain range.
    [27]
    27. Dose measurement method according to any of claims 22 to 26, characterized in that it comprises storing in a memory (16) a history of inhalations performed and measurements of inhaled doses.
    [28]
    28. Dose measurement method according to any of claims 22 to 27, characterized in that it comprises wirelessly sending to a mobile device (50) a history of inhalations performed and measurements of inhaled doses.
    [29]
    29. Dose measurement method according to claim 28, characterized in that it comprises:
    checking, on the mobile device (50), compliance with a predetermined inhalation treatment based on the history of inhalations performed and measurements of inhaled doses;
    send at least one notification and / or alert (52) informing about compliance with inhalation treatment.
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    同族专利:
    公开号 | 公开日
    WO2021037462A1|2021-03-04|
    ES2807698B2|2022-01-03|
    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    US20090314292A1|2008-06-20|2009-12-24|Dennis Overfield|Interactive apparatus and method for real-time profiling of inhalation efforts|
    US20190175847A1|2016-05-19|2019-06-13|John J. POCREVA, III|Apparatus, system and method for detecting and monitoring inhalations|
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    ES2604482T3|2010-06-18|2017-03-07|Boehringer Ingelheim International Gmbh|Inhaler|
    CN106999681B|2014-08-28|2021-02-02|诺顿（沃特福特）有限公司|Compliance aid module for an inhaler|
    MX2017002550A|2014-08-28|2017-05-25|Microdose Therapeutx Inc|Compliance monitoring module for an inhaler.|
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    法律状态:
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    优先权:
    申请号 | 申请日 | 专利标题
    ES201930752A|ES2807698B2|2019-08-23|2019-08-23|DEVICE AND METHOD OF DOSE MEASUREMENT IN DRY POWDER INHALER|ES201930752A| ES2807698B2|2019-08-23|2019-08-23|DEVICE AND METHOD OF DOSE MEASUREMENT IN DRY POWDER INHALER|
    PCT/EP2020/071222| WO2021037462A1|2019-08-23|2020-07-28|Dose measuring device and method in inhalers|
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