System for detecting and monitoring inhalation

Abstract

To provide an interactive apparatus and method for sensing and measuring real-time characteristic patterns of use of a dry powder inhalation system.SOLUTION: An inhaler accessory apparatus 18 comprises: a body configured to be mounted on or connected with an inhaler 14; a microprocessor; at least two pressure sensors, a first pressure sensor for detecting information on environmental conditions around the inhaler, and a second pressure sensor for detecting signals generated from the inhaler when in use; and a pressure equalization channel between the first pressure sensor and the second pressure sensor. The first pressure sensor and the second pressure sensor each generate at least one signal which is processed in the microprocessor resulting in customized microprocessor output. The microprocessor output generates a pressure differential versus time curve on a display concurrently with or immediately after a user's inhalation.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 62 / 662,051, filed Apr. 24, 2018, the entire content of which is incorporated herein by reference. This specification describes an interactive device and method for recording, transferring, and displaying physical measurements based on real - time physiological conditions generated by an inhaler and / or a subject during inhalation.

[0002] Inhalers for metering and dispensing therapeutic substances via the airway, particularly for pulmonary delivery in the treatment of local or systemic diseases, are commercially available. For example, nebulizers, which are devices containing propellants, and dry powder inhalers have been used in the treatment of diseases such as asthma, airway infections, and systemic diseases, such as diabetes. In the treatment of diseases, the efficiency of delivering the required dosage of therapeutic substance to the patient depends on the efficiency of the device, and the overall efficiency can be enhanced, for example, by providing an appropriate feedback mechanism to the patient, clinician, or physician during use of the device to teach the patient proper inhalation techniques. Improper use of the device and crude inhalation techniques can result in a lack of effectiveness in the treatment of diseases. For example, administering a lower or higher dosage of therapeutic substance than intended can be harmful to the patient. To effectively deliver the therapeutic substance to the airway, the patient or user can be trained or instructed to use the device properly.

Background Art

[0003]

[0004]

[0005] ​​​​​​​​​​​Dry powder inhalers used to deliver drugs to the lungs typically contain a single-dose powder formulation, either in bulk supply or quantified into multiple individual doses stored in unit-dose compartments such as hard gelatin capsules, cartridges, or blister packs. Dose reproducibility requires that the formulation be uniform and that the dose can be delivered to the patient with consistent reproducible results. Therefore, dosing can be improved by optimizing the release of the formulation, which can be achieved, for example, by having the patient perform an appropriate inhalation maneuver to achieve the required dose . Devices for training patients to appropriately deliver therapeutic substances through the pulmonary tract are described, for example, in U.S. Patent No. 5,333,106, which discloses an apparatus for interactively training patients who use an aerosol inhaler including a feedback display based on airflow-volume data using inhalation steps in an appropriate sequence .

[0006] U.S. Patent Application No. 10 / 759,859 (U.S. Patent Application Publication No. 2004 / 0187869) discloses a training device for a drug inhaler, such as a dry powder inhaler, which is based on measuring a pressure difference and displaying a single value corresponding to both the speed and the peak inhalation flow rate using a dry powder inhaler simulator . U.S. Patent Nos. 8,499,757 and 8,636,001, which teach in their entirety with respect to dry powder inhalers, are hereby incorporated by reference in their entireties into this specification .

[0007] ​​​​​​Dry powder inhalers and cartridge systems, such as those described in , can produce primary drug particles or suitable plume-like inhaled smoke during an inhalation operation by deaggregating the powder formulation in the inhaler and in the capsule or cartridge. The benefits of drug delivery by pulmonary circulation are numerous and include rapid entry into the arterial circulation, avoidance of first-pass drug degradation by hepatic metabolism, and ease of use, e.g., absence of discomfort compared to other routes of administration such as injection. These devices have been used in clinical settings and are currently commercially available.

[0008] An interactive device and method for profiling inhalation effort are disclosed in U.S. Patent No. 9,364,619, the disclosure of which is incorporated herein by reference.

SUMMARY OF THE INVENTION

PROBLEMS TO BE SOLVED BY THE INVENTION

[0009] In the art, there is a need for improvements in the design and manufacture of inhalers that maximize accuracy and minimize the training and effort required of the subject in the proper use of the inhalation system, and that monitor the patient during use of the inhalation system and throughout the overall care flow, as well as improvements in the flexibility of application of inhalers and inhaler components, including the reusability of the drug package and the overall such system. The present disclosure presents devices and methods for achieving these goals.

[0010] This specification describes a method for detecting and measuring the inspiratory A dialogue device, including an inhaler and a method of using the inhaler by a patient in combination with the device is described. In the disclosed embodiments, the device and the method of using the device are, for example, when sensing, detecting, measuring, and monitoring a characteristic inhalation profile, i.e., a breathing pattern, of a subject collecting data generated from an inhalation operation by the subject and using it in a treatment plan while identifying the effort required to deliver an appropriate dose or therapeutic dose using an inhaler provided to the subject is useful. The device and method are also useful, for example, for training / teaching a subject so that the subject can effectively treat a disease, disorder, or condition with an inhaler such that the subject receives the drug being delivered at an appropriate dose. In certain embodiments, the device may include any inhaler, particularly a high-resistance dry powder inhaler, to deliver one or more pharmaceutically active ingredients or drugs to the lungs of a subject being treated, and thus to the pulmonary circulation and systemic circulation. In some embodiments, the dry powder inhaler is actuated by breathing, and when used by a patient the patient can observe the degree of effort during inhalation, which is displayed simultaneously with the actual inhalation being performed . Exemplary embodiments of the inhalation devices and systems disclosed herein include an inhaler attachment device that is a separate device; the inhaler attachment device is adaptable or attachable to an inhaler such that it can be in close contact with or attached to the inhaler during use and removed from the inhaler after use .

[0011] In some embodiments, a detection and monitoring system is provided that includes an inhaler used by a patient and a corresponding inhaler attachment device, the inhaler attachment device being adapted to the inhaler and being capable of being in close contact with or attached to the inhaler during use and removed from the inhaler after use .

[0012] In some embodiments, a detection and monitoring system is provided that includes an inhaler used by a patient and a corresponding inhaler attachment device, the inhaler attachment device being adapted to the inhaler and being or are adapted to fit together so that the inhaler can be removed from the inhaler accessory. and the patient is able to inhale one or more of the devices prescribed by a physician for inhalation. An inhaler is required and may be used to self-administer a dose of medication. The device includes a body structurally configured to engage with an inhaler prescribed to a patient, and a Light emitting diodes (LEDs) (e.g., for power ON and battery charge status or other status) Display screens, including LCDs, touch screens, or other interactive displays (which may be small enough to fit on the inhaler accessory device). (which may be modeled or located remotely in other parts of the detection and surveillance system), an optional display means for displaying a target signal, a microprocessor and one or more sensors; In some embodiments, the inhaler accessory device includes an electronic board including a The device includes a receiver and a transmitter or transceiver for sensing the signal produced, which may be wireless or radio. Wi-Fi, computers, personal digital assistants (PDAs), tablets, and / or mobile phones / smartphones communicate with your phone, smartwatch, or smartglasses to communicate with your device within an application or other In this way, information from the inhalation maneuver being performed by the patient or user is collected in real time. The inhaler accessory also preferably displays the serial number ( For example, a USB port or other port may be included to allow data transfer and battery charging. to.

[0013] In some embodiments, an inhalation accessory device is provided for coupling to an inhalation device of a subject. and; activating the inhalation attachment system; and, while the subject is inhaling, monitoring inhalation by a subject by means of a device, and facilitating the training and / or monitoring of the subject to achieve an optimal or appropriate inspiration manoeuvre for the effective delivery of a treatment to the respiratory system facilitating the training of the subject regarding the proper use of an inhaler to achieve a preferred flow profile for that individual, such that optimal delivery of the drug can be achieved A method is provided that includes detecting a preferred flow profile for an individual to achieve optimal delivery of a drug, facilitating training of the subject regarding proper use of an inhaler, and monitoring performance of an inhalation system provided to a patient to detect, for example, a dose being delivered; quantification of a drug being delivered; duration of release of a dose being delivered; number of dosing events administered to the subject; monitoring mechanical integrity of the inhalation system in real time, and / or storing data for future analysis. In some embodiments, an inhaler or multiple parts of an inhaler (such as a cartridge) that can be used with an inhaler accessory device can include a code or identifier, such as radio frequency identification (RFID), colour coding, laser etching, text, etc.

[0014] In an exemplary embodiment, an inhaler accessory device for an inhalation monitoring system can be manufactured to interact. For example, the device can include a wireless communication interface that enables remote data acquisition, and the data can be transmitted to a computer, tablet, smartphone or other microprocessor-based system to provide an interactive display of the data, storage of the data, and / or web-based transfer of the information. Alternatively, other exemplary embodiments can include a wired communication interface.

[0015] In an exemplary embodiment, the device can be, for example, as described in U.S. Patent No. 7,305,986 and and U.S. Patent No. 7,464,706, U.S. Patent No. 8,499,757; U.S. Patent No. 8,424,518, and U.S. Patent No. 8,636,001 (relating to all disclosures regarding dry powder inhalers, and incorporating the entire disclosures of all of them herein by reference), such as those described as being adaptable to a high resistance dry powder inhalation system. The apparatus can include a dry powder inhaler with or without a cartridge containing a formulation, one or more transducers including electrical, electronic, electromechanical, electromagnetic, photonic or photovoltaic, for example pressure sensors, temperature sensors, sound sensors, and optical sensors; signal conditioning circuitry and / or software programs, means for communicating electronic signals, and an output display. In such an exemplary embodiment, the apparatus can be used with an analog or digital sensor, an appropriate signal conditioner such as amplification, signal filtering, or analog-to-digital conversion, a microprocessor for on-board processing, a wireless communicator for communicating with a remote computer, a tablet computer, a cellular phone, a personal digital assistant (PDA) for subsequent signal processing, and / or a real-time output display. The apparatus can be used to deliver a pharmaceutical composition contained in a pre-metered unit dose cartridge containing an active ingredient for delivery to the pulmonary circulation. In an alternative exemplary embodiment, the sensing and monitoring device can be adapted onto or within an inhalation system including a dry powder inhaler having a cartridge that can be empty or can contain a dry powder suitable for pulmonary delivery. In one embodiment, the inhaler accessory is configured to attach to or connect with the inhaler

[0016] ​​​​​​​​​a formed body; a microprocessor, at least two pressure sensors, for example, a first pressure sensor for detecting encrypted or coded information in the area or part of the inhaler ; and a second pressure sensor for detecting a signal generated from the inhaler during use and optionally a pressure equalization channel between the first pressure sensor and the second pressure sensor, wherein the first pressure sensor and the second pressure sensor each generate at least one signal, and the signal is processed by the microprocessor to become a customized microprocessor output, and the microprocessor output generates a pass or fail indication when the user's inhalation operation is completed. In certain embodiments, the inhaler accessory device generates a graphical display of the pressure-time curve characteristics of the inhalation operation performed by the user and compares the user's performance to a graph of pre-determined ideal profile values for the inhaler type, including a

[0017] microprocessor. In another embodiment, the inhaler accessory device includes a first pressure sensor and a second pressure sensor, which are digital sensors and whose outputs are in digital form. In this embodiment, the inhaler accessory device is configured such that the second pressure sensor is an analog sensor and its output is in analog form, and the device further includes additional circuitry for performing operations such as conditioning, filtering, amplifying, and / or converting the sensor signal to digital form. The second pressure sensor can detect a pressure A sound sensor that detects an acoustic signal, including the amplitude of the signal, the frequency of the audio signal, or a combination thereof. In an alternative embodiment, the inhaler attachment may include a sound sensor, and the sound sensor is a microphone. The device detects color within multiple portions of an inhaler, inhaler cartridge, or other medication packaging. A laser beam, a Doppler sensor, an infrared sensor, The sensor or other sensing beam may be used.

[0018] In certain embodiments, the inhaler accessory device comprises a cartridge and a dry powder formulation. In one embodiment, the dry powder formulation comprises a diketopiperidine. and at least one active ingredient, and the inhaler accessory device has at least two segments. a pressure sensor for detecting a pressure difference within the inhaler, and an absolute pressure sensor used in conjunction with a differential pressure sensor to detect the pressure drop measured If so, the pressure drop is adjusted for atmospheric conditions before identifying it. The inhaler accessory device includes a pressure equalization chamber for equalizing the pressure in the inhaler with the environment. Without a pressure equalization channel, the accuracy of pressure measurements will be inconsistent and unreliable. This makes the measurement process inefficient.

[0019] The inhaler accessory further comprises an inhaler cartridge or other drug package inserted into the inhaler. A color detection sensor for detecting the color of the medicine, a cartridge or other medicine inserted in the inhaler An RFID reader for reading the RFID tag in the package and an inhaler or or letters, codes or text provided on an inhaler cartridge or other drug packaging In some embodiments, the sensor includes one or more image detection sensors capable of identifying information. The accessory device for the inhaler further includes a wireless transceiver through which data received from at least two sensors is transmitted to a remote processing system. The accessory device for the inhaler may also further include an electronic board (the microprocessor, sensors, and wireless transceiver are connected to and / or arranged on the electronic board), and a visible indicator or a display that indicates pass / fail to the user. In some embodiments, the microprocessor may have a customized microprocessor output that includes threshold data customized for the signal generated by the first pressure sensor, and may also have an output that generates a pressure-versus-time curve on the display simultaneously with or immediately after the patient's inhalation. In one embodiment, the accessory device for the inhaler includes, for example, a statistical algorithm for classifying colors for detecting colored objects, including a plurality of parts of the inhaler, capsules, and cartridges, and these colors are used to correlate information such as the capsule / cartridge type, the strength of the dose provided by the drug identified by the color, etc. In an alternative embodiment, the dry powder inhalation monitoring and detection system includes a dry powder inhaler; a microprocessor, a wireless transceiver, and a first pressure sensor for detecting encoded or coded information in the area or part of the inhaler; and a second pressure sensor that detects a signal generated by the inhaler during use and communicates with the first sensor through a pressure equalization channel. The first and second pressure sensors each generate at least one signal, and the signals are processed by the microprocessor to obtain a customized microprocessor output. In one embodiment, the accessory device for the inhaler includes, for example, a statistical algorithm for classifying colors for detecting colored objects, including a plurality of parts of the inhaler, capsules, and cartridges, and these colors are used to correlate information such as the capsule / cartridge type, the strength of the dose provided by the drug identified by the color, etc. using an algorithm, and these colors are used to correlate information such as the capsule / cartridge type, the strength of the dose provided by the drug identified by the color, etc. for correlation.

[0020] In an alternative embodiment, the dry powder inhalation monitoring and detection system includes a dry powder inhaler; a microprocessor, a wireless transceiver, and a first pressure sensor for detecting encoded or coded information in the area or part of the inhaler; and a second pressure sensor that detects a signal generated by the inhaler during use and communicates with the first sensor through a pressure equalization channel. The first and second pressure sensors each generate at least one signal, and the signals are processed by the microprocessor to obtain a customized microprocessor output. from the inhaler during use and communicates with the first sensor through a pressure equalization channel. The first and second pressure sensors each generate at least one signal, and the signals are processed by the microprocessor to obtain a customized microprocessor output, and the first and second pressure sensors each generate at least one signal, and the signals are processed by the microprocessor to obtain a customized microprocessor output, where the signals are processed by the microprocessor to obtain a customized becomes an e-crop processor output, and the microprocessor output generates a pass or fail indication when the user's inhalation operation is completed. In this embodiment, the dry powder inhalation monitoring and detection system further includes a display, a wireless transceiver, a threshold value corresponding to the detected first pressure sensor information, and a microprocessor configured to graphically report on the display a pass or fail indication including the user inhalation data indicating the second pressure sensor. A remote processing system is included that includes the microprocessor configured as such.

[0021] Dry powders containing microparticles suitable for pulmonary delivery are well known in the art, for example, those disclosed in U.S. Patent Nos. 8,499,7 57 and 8,636,001 (all disclosures regarding microparticles are incorporated herein by reference in their entirety). In each exemplary embodiment, the dry powder, the active ingredient can be a protein, peptide, or polypeptide, and combinations thereof, for example, an endogenous secreted hormone, such as insulin, glucagon-like peptide 1 (GLP-1), an epithelial body hormone or an analog thereof. In some embodiments, the dry powder formulation for delivery to the pulmonary circulation contains an active ingredient or active agent including a peptide, protein, hormone, analog thereof or a combination thereof, and the active ingredient is insulin, calcitonin, growth hormone, treprostinil, pa

[0022] In some embodiments, the dry powder formulation for delivery to the pulmonary circulation contains an active ingredient or active agent including a peptide, protein, hormone, analog thereof or a combination thereof, and the active ingredient is insulin, calcitonin, growth hormone, treprostinil, pa lonosetron, tobramycin, filgastrin, erythro poietin, granulocyte macrophage colony-stimulating factor (GM-CSF), chorionic gonadotropin hormone, and the like. Ropin releasing factor, luteinizing hormone releasing hormone, follicle stimulating hormone (FSH), vasoactive intestinal peptide, parathyroid hormone (including crocuma PTH), parathyroid hormone related protein quality, glucagon-like peptide-1 (GLP-1), exendin, ramlintide, oxyntomodulin, peptide YY, deoxyribonuclease 1, interleukin 2-induced tyrosine kinase, Bruton's tyrosine kinase (BTK), inositol-requiring kinase 1 (IRE1), or an analog thereof, active fragment, PC-DAC-modified derivative, or its O-glycosylated form, epi nephrin, antibacterial or antifungal agent. In certain embodiments, the pharmaceutical composition or dry powder formulation contains fumaryl diketopiperazine, and the active ingredient is insulin, parathyroid hormone 1-34, GLP-1, oxyntomodulin, peptide YY, heparin, epi parathyroid hormone releasing peptide (PTHrP), neurotransmitter agonists and antagonists, such as 5 -hydroxytryptamine receptor agonists and antagonists, prostacyclin i.e. PGI 2, epinephrine, norepinephrine, and one or more selected from its analogs.

[0023] In an exemplary embodiment described herein, the device includes a sensor that communicates with a dry powder inhaler, and the sensor detects at least one signal type including a pressure signal, a flow signal, a temperature signal, and an audio signal generated from the dry powder inhalation system, and can transmit the signal to at least one device for analysis, storage, printing, or display. In such an exemplary embodiment, the sensor is configured within the dry powder inhaler ​or is compatible with a dry powder inhaler, and the sensor can be a microphone .

[0024] In an exemplary embodiment, the inhalation system has a high resistance to airflow and about 0.065 (√kPa) / liter per minute to about 0.200 (√kPa) / liter per minute and includes a dry powder inhaler having a resistance value of. The high resistance inhalation system may include a sensing and monitoring device . In some embodiments, the sensor can detect a unique characteristic signal generated by the inhalation system during use . In another exemplary embodiment, the sensor is a sound sensor which includes a sound detection device or microphone configured to transmit an audio signal in a wired or wireless communication mode to at least one other device within the system . The sensing and monitoring device for the dry powder inhaler described in this specification may further be associated with an analog-to-digital converter that communicates at least one signal, such as an audio signal, to a microprocessor configured to analyze and process the signal . In another exemplary embodiment , at least one device is an analog-to-digital converter . In an exemplary embodiment, a monitoring system for a dry powder inhaler is described, the monitoring system comprising: a monitoring device including at least one sensor; an analog-to-digital converter; a data

[0025] storage medium including a set of machine-readable instructions executable by a processing device to execute an algorithm, the algorithm comprising: receiving data from at least one sensor; filtering the data; converting the data ; analyzing the data; and using the data to monitor a patient . The data storage medium includes a set of machine-readable instructions executable by a processing device to execute an algorithm . The algorithm includes: receiving data from at least one sensor ; filtering the data ; converting the data; analyzing the data; and using the data to monitor a patient It includes instructions for manipulating data, including one or more of the following.

[0026] In an exemplary embodiment where at least one sensor is a microphone, the sensor is provided anywhere within the inhaler, for example, within the airflow conduit, within the wall of the inhaler, or external to the inhaler as part of a separate piece. In another exemplary embodiment, the monitoring device can be a removable device that can be detachably attached or mounted to a dry powder inhaler. Further in another exemplary embodiment, the monitoring device provides a graphical representation that is a real-time graph of the inhalation. In another exemplary embodiment, the monitoring device provides a graphical representation that is a real-time graph of the inhalation. In another exemplary embodiment, the monitoring device provides a graphical representation that is a real-time graph of the inhalation. In another exemplary embodiment, the monitoring device provides a graphical representation that is a real-time graph of the inhalation.

[0027] In another exemplary embodiment, the audio signal is the amplitude of the audio signal, the frequency of the audio signal, or a combination thereof. In yet another exemplary embodiment, the sensor further measures at least one audio signal at different frequencies. In another exemplary embodiment, the dry powder inhaler further includes a cartridge, and the cartridge may include a dry powder for pulmonary delivery. Further, the dry powder may include diketopiperazine microparticles and at least one active ingredient. In yet another embodiment, at least one drug includes insulin, GLP-1, epithalamic hormone, calcitonin, analogs thereof, or combinations thereof. In another exemplary embodiment, the dry powder inhaler further includes a cartridge, and the cartridge may include a dry powder for pulmonary delivery. Further, the dry powder may include diketopiperazine microparticles and at least one active ingredient. In yet another embodiment, at least one drug includes insulin, GLP-1, epithalamic hormone, calcitonin, analogs thereof, or combinations thereof. In another exemplary embodiment, the dry powder inhaler further includes a cartridge, and the cartridge may include a dry powder for pulmonary delivery. Further, the dry powder may include diketopiperazine microparticles and at least one active ingredient. In yet another embodiment, at least one drug includes insulin, GLP-1, epithalamic hormone, calcitonin, analogs thereof, or combinations thereof. In another exemplary embodiment, the dry powder inhaler further includes a cartridge, and the cartridge may include a dry powder for pulmonary delivery. Further, the dry powder may include diketopiperazine microparticles and at least

[0028] In a further embodiment, the sensing and / or monitoring device is configured to detect a signal from the dose being delivered. In this embodiment, the sensing and monitoring system can detect the movement of powder particles within the inhaler and cartridge system in use from the start of powder delivery from the cartridge to the end of powder particle delivery, and the sensor is the sound of the inhaler and the inhalation system In a further embodiment, the sensing and / or monitoring device is configured to detect a signal from the dose being delivered. In this embodiment, the sensing and monitoring system can detect the movement of powder particles within the inhaler and cartridge system in use from the start of powder delivery from the cartridge to the end of powder particle delivery, and the sensor is the sound of the inhaler and the inhalation system In a further embodiment, the sensing and / or monitoring device is configured to detect a signal from the dose being delivered. In this embodiment, the sensing and monitoring system can detect the movement of powder particles within the inhaler and cartridge system in use from the start of powder delivery from the cartridge to the end of powder particle delivery, and the sensor is the sound of the inhaler and the inhalation system In a further embodiment, the sensing and / or monitoring device is configured to detect a signal from the dose being delivered. In this embodiment, the sensing and monitoring system can detect the movement of powder particles within the inhaler and cartridge system in use from the start of powder delivery from the cartridge to the end of powder particle delivery, and the sensor is the sound of the inhaler and the inhalation system Detect changes in the unique properties of the sound of the powder particles resulting therefrom. The data obtained from the detection is analyzed and can be correlated with the dose of the drug released or delivered externally from the inhalation system, the course of dose delivery time, and the performance of the inhalation system.

[0029] In another exemplary embodiment, the sensing and monitoring device can be provided as a removable device, such as a housing or saddle structure, that is adaptable to a dry powder inhaler. In this embodiment the removable device facilitates the use of the inhalation system because the structure or form of the dry powder inhaler is not modified. Therefore, once the characteristic performance of the inhaler is determined and the subject can use it properly, the same inhaler can be used without the housing. In the embodiments of the present specification sensors such as small microphones can be suitably arranged in any area of the housing, including being embedded in the wall of the housing or adapter, or protruding from the wall of the housing. In this embodiment, the sensing and monitoring device provides a greater resolution of the sound characteristics generated from the dry powder inhaler and cartridge system in use. Once the characteristic performance of the inhaler is determined and the subject can use it properly, the same inhaler can be used without the housing. Once the characteristic performance of the inhaler is determined and the subject can use it properly, the same inhaler can be used without the housing. In the embodiments herein, sensors such as small microphones can be suitably arranged in any area of the housing, including being embedded in the wall of the housing or adapter, or protruding from the wall of the housing. In the embodiments herein, sensors such as small microphones can be suitably arranged in any area of the housing, including being embedded in the wall of the housing or adapter, or protruding from the wall of the housing. In this embodiment, the sensing and monitoring device provides a greater resolution of the sound characteristics generated from the dry powder inhaler and cartridge system in use. In this embodiment, the sensing and monitoring device provides a greater resolution of the sound characteristics generated from the dry powder inhaler and cartridge system in use.

[0030] In one embodiment, a method for measuring the pressure difference during an inhalation operation is described, the method comprising: providing an inhaler to a subject, the inhaler including a sensor configured to detect at least one amplitude of an audio signal generated from the inhaler, at least one frequency of the audio signal, or a combination thereof; having the subject inhale for at least 1 second ; using an algorithm provided to a microprocessor in a computer system to determine at least one amplitude of the audio signal, at least one frequency of the audio signal, or a combination thereof ; using an algorithm provided to a microprocessor in a computer system to determine at least one amplitude of the audio signal, at least one frequency of the audio signal, or a combination thereof ; using an algorithm provided to a microprocessor in a computer system to determine at least one amplitude of the audio signal, at least one frequency of the audio signal, or a combination thereof ; using an algorithm provided to a microprocessor in a computer system to determine at least one amplitude of the audio signal, at least one frequency of the audio signal, or a combination thereof ; using an algorithm provided to a microprocessor in a computer system to determine at least one amplitude of the audio signal, at least one frequency of the audio signal, or a combination thereof Analyzing these combinations to generate a data set; and displaying, printing, or storing the data set according to time and pressure including displaying, printing, or storing the data set.

[0031] In a further embodiment, described herein is a monitoring system for a dry powder inhaler wherein the monitoring system includes: at least one sensor including an acoustic sensor, a Doppler, a monitoring device; an analog-to-digital converter; and a data storage medium, the data storage medium including a set of machine-readable instructions executable by a processing device to execute an algorithm, the algorithm including steps of receiving data from at least one sensor; filtering the data; converting the data; analyzing the data; and using the data to monitor a patient, including instructions for manipulating the data, and a monitoring system is described. is described.

[0032] Further, in some embodiments, described herein is a method for measuring a pressure difference during an inhalation operation, the method comprising: providing an inhaler to a subject, the inhaler including at least one sensor configured to detect at least one amplitude of an acoustic signal, at least one frequency of the acoustic signal, or a combination thereof generated from the inhaler, causing the subject to inhale for at least 1 second; using an algorithm provided to a computer system to analyze at least one amplitude of the acoustic signal, at least one frequency of the acoustic signal, or a combination thereof to generate a data set; and displaying, printing, or storing the data set according to time and pressure, the method is described.

[0033] In other embodiments, provided herein is an interactive type dry powder inhalation system for monitoring inhalation performed by a user, comprising: at least one microprocessor, and one or more active sensors including a Doppler effect sensor and / or an infrared sensor capable of measuring an air or gas flow, an inhalation accessory; a dry powder inhaler, including a sensation beam including a laser beam, an RFID, an optical recognition, an image sensor, etc., a type identifier that can be recognized, such as a color, a laser etching, a printed number; a cartridge having printed words, the sensation beam being capable of detecting an identifier code integrally configured in the cartridge for detecting a color, a type of dosage; a dosage, etc., an interactive dry powder inhalation system including a dry powder inhaler is described. The image detection sensor can be used in combination with on-board calculation or remote calculation to detect a dosage or other identifier using optical character recognition. In some embodiments, the dry powder inhaler has a flow resistance value of 0.065 (√kPa) / liter per minute to 0.200 (√kPa) / liter per minute, a transducer configured to detect a signal generated from the inhaler during use, and a display device configured to display the inhalation operation performed by the user in real time. In another embodiment, the transducer senses and measures the pressure difference within the inhaler. Further, the transducer can be a flow meter configured to sense and measure the flow rate through the air conduit of the dry powder inhaler. The transducer can be, for example, a microphone configured to sense and measure an audio signal generated from within the inhaler. A dry powder inhalation system of the type: Including a Doppler effect sensor and / or an infrared sensor capable of measuring an air or gas flow One or more active sensors, an inhalation accessory; a dry powder inhaler, A sensation beam including a laser beam, RFID, optical recognition, image sensors, etc., A type identifier that can be recognized, such as a color, a laser etching, a printed number; printed words Including a cartridge having, the sensation beam being capable of detecting an identifier code integrally configured in the cartridge for detecting a color, a type of dosage; a dosage, etc. A dry powder inhaler capable of detecting an identifier code integrally configured in the cartridge for detecting a color, a type of dosage; a dosage, etc. An interactive dry powder inhalation system including a dry powder inhaler is described. The image detection sensor Uses optical character recognition to detect a dosage or other identifier, and can be used in combination with on-board calculation or remote calculation. In some embodiments, the dry powder inhaler has a Flow resistance value of 0.065 (√kPa) / liter per minute to 0.200 (√kPa) / liter per minute A transducer configured to detect a signal generated from the inhaler during use, And a display device configured to display the inhalation operation performed by the user in real time. In another embodiment, the transducer senses and measures the pressure difference within the inhaler. Furthermore, the transducer can be a flow meter configured to sense and measure the flow rate through the air conduit of the dry powder inhaler. The transducer can be, for example, a microphone configured to sense and measure an audio signal generated from within the inhaler. For example, a microphone configured to sense and measure an audio signal generated from within the inhaler. Can be a microphone configured to sense and measure an audio signal generated from within the inhaler.

[0034] In yet other embodiments, the present specification describes a sensing and monitoring device adapted to a dry powder inhaler, comprising: a removable device structurally configured to be adapted to the dry powder inhaler, the removable device including a microphone for detecting sound generated within the dry powder inhaler; and the dry powder inhaler having a flow resistance value of from 0.065 (√kPa) / liter per minute to 0.200 (√kPa) / liter per minute. A sensing and monitoring device is described. In yet other embodiments, there is provided a sensing and monitoring device for a dry powder inhalation system, the dry powder inhalation system including a dry powder inhaler and a cartridge, and the sensing and monitoring device including a microphone configured to detect an audio signal generated from a dry powder formulation discharged from the dry powder inhalation system. A sensing and monitoring device is described. In some embodiments, the dry powder inhaler includes a housing, a movable member, and a mouthpiece, the movable member being operably configured to move a container from a powder containment position to a dosing position. In this and other embodiments, the movable member may be configured as part of a lid assembly at the proximal end of the inhaler and form a part of the cartridge mounting area. In this embodiment, the mouthpiece is integrally constructed with a cover portion that covers the housing over the cartridge mounting area when the lid or inhaler is closed. By moving the mouthpiece in a downward direction from a horizontal plane, the lid or cover is angularly moved to a vertical position, opening the inhaler and providing access to the interior of the inhaler and the cartridge. The sound detected by the microphone is used to determine the operation of the dry powder inhaler. For example, the sound characteristics can provide information about the powder flow rate, powder ejection efficiency, and the integrity of the dosing process. By analyzing the detected sound, it is possible to assess whether the dry powder inhaler is operating properly and whether the desired dosing accuracy is achieved. The flow resistance value of the dry powder inhaler is an important parameter that affects the inhalation experience and the delivery of the dry powder formulation. A flow resistance value within the specified range ensures that the powder can be inhaled smoothly and efficiently while still maintaining proper dosing control. Different inhalation devices may have different optimal flow resistance values depending on the characteristics of the dry powder formulation and the design of the inhaler. In some embodiments, the sensing and monitoring device may further include a processing unit for analyzing the detected sound and flow resistance data. The processing unit can be configured to generate alerts or provide feedback to the user based on the analysis results. For example, if the detected sound indicates an abnormal operation or if the flow resistance value is outside the acceptable range, the processing unit can send a signal to a display or a connected device to notify the user.

[0035] Furthermore, in some embodiments, the sensing and monitoring device for the dry powder inhalation system can be integrated with other components of the system, such as a controller or a communication module. This allows for seamless interaction and coordination between the sensing and monitoring functions and other system operations. For example, the integrated device can communicate with the controller to adjust the operation of the dry powder inhaler based on the detected data. The sensing and monitoring device can also be configured to store the detected data for later analysis. This can be useful for evaluating the long-term performance of the dry powder inhaler and for identifying any trends or patterns in the operation. The stored data can be accessed through a connected device or a dedicated interface for further investigation and optimization of the inhalation therapy. In addition, the sensing and monitoring device may be designed to be portable and easy to use. It can be powered by a battery or other suitable power source and can be easily attached or detached from the dry powder inhaler. This allows for convenient monitoring of the inhaler's operation during different usage scenarios, such as at home or on the go. The microphone in the sensing and monitoring device is typically a sensitive component that can detect a wide range of sound frequencies relevant to the operation of the dry powder inhaler. It is designed to be resistant to environmental noise and interference to ensure accurate detection of the sound generated by the powder formulation. The microphone's performance and sensitivity can have a significant impact on the effectiveness of the sensing and monitoring function. The design of the dry powder inhaler and the sensing and monitoring device can be optimized to improve the overall performance and user experience. For example, the shape and size of the inhaler can be designed to fit comfortably in the user's hand, and the placement of the microphone and other components can be carefully considered to ensure accurate detection and reliable operation.

[0036] In some embodiments, the sensing and monitoring device may be able to communicate with other healthcare devices or systems, such as a patient management platform or a healthcare provider's server. This enables the sharing of the detected data and the inhalation therapy information, allowing for remote monitoring and personalized healthcare management. The movable member in the dry powder inhaler plays a crucial role in the dosing process. By precisely moving the container from the powder containment position to the dosing position, it ensures accurate delivery of the dry powder formulation. The movement of the movable member can be controlled by various mechanisms, such as a spring-loaded system or a motor-driven mechanism. The lid assembly and the cartridge mounting area in the dry powder inhaler are designed to ensure proper alignment and secure attachment of the cartridge. This helps to prevent leakage of the dry powder formulation and ensures consistent dosing. The lid or cover can be designed to be easily opened and closed, providing convenient access to the cartridge for refilling or replacement. The mouthpiece of the dry powder inhaler is an important interface between the user and the inhaler. Its design and construction can affect the ease of inhalation and the comfort of the user. The mouthpiece may be made of a soft and flexible material to provide a comfortable fit in the user's mouth and to prevent leakage of the inhaled air. The movement of the mouthpiece to open the inhaler is a simple yet effective mechanism. It allows for quick and easy access to the interior of the inhaler, enabling the user to load or unload the cartridge and ensuring proper operation of the dosing system. The design of this movement can be optimized to provide a smooth and reliable operation. The cover portion of the mouthpiece that covers the housing over the cartridge mounting area helps to protect the internal components of the dry powder inhaler and prevent contamination. It also provides a seal to ensure that the inhaled air flows through the proper channels and that the dry powder formulation is delivered effectively. The downward movement of the mouthpiece from the horizontal plane is a key operation in the dry powder inhaler. It triggers the opening of the inhaler and allows for the inhalation process to begin. The amount of movement and the speed of the movement can be designed to be appropriate for the specific design and requirements of the inhaler. The angular movement of the lid or cover to the vertical position not only opens the inhaler but also provides clear access to the interior. This allows for easy inspection, cleaning, or replacement of the cartridge or other components. The design of this angular movement can be optimized to ensure a smooth and reliable operation. Enable it to be loaded and removed. Conversely, the upward movement from the vertical plane to the horizontal plane of the mouthpiece causes the closure of the inhaler and automatically creates an opening in the air passage between the inhaler and the cartridge inserted into the cartridge mounting area.

[0037] In another embodiment, the dry powder inhaler includes a body, a housing, and a mouthpiece; the inhaler has an open position, a closed position, and receives, holds, and when the inhaler is moved from the open position to the closed position, the inhaler has a mechanism operably configured to reconfigure from a containment position to a metering, dosing, or dosing delivery position. In multiple versions of this embodiment, the mechanism can also reconfigure the cartridge installed in the inhaler from the dosing position to the containment position when the used cartridge is removed after use when the inhaler is opened. In some embodiments, the mechanism can reconfigure the cartridge into a disposable or discarded form after use. In some embodiments, the body of the inhaler includes a proximal portion including a mouthpiece, a body, and a distal portion including a housing structurally configured as a detachable cover covering the upper sides of multiple parts of the body and multiple internal components of the inhaler; the housing includes a distal end and a proximal end, and the proximal end has an opening adapted to and enclosing a portion of the inhaler body. In some embodiments, the proximal end contacts or abuts against the inhaler body to close the inhaler from the external environment. The inhaler is opened by moving the housing in a translational motion in the distal direction across the body from the closed configuration, and an inhaler loading for inserting or removing a cartridge

[0038] In some embodiments, the body of the inhaler includes a proximal portion including a mouthpiece, a body, and a distal portion including a housing structurally configured as a detachable cover covering the upper sides of multiple parts of the body and multiple internal components of the inhaler; the housing includes a distal end and a proximal end, and the proximal end has an opening adapted to and enclosing a portion of the inhaler body. In some embodiments, the proximal end contacts or abuts against the inhaler body to close the inhaler from the external environment. The inhaler is opened by moving the housing in a translational motion in the distal direction across the body from the closed configuration, and an inhaler loading for inserting or removing a cartridge including a distal end and a proximal end, and the proximal end has an opening adapted to and enclosing a portion of the inhaler body. In some embodiments, the proximal end contacts or abuts against the inhaler body to close the inhaler from the external environment. The inhaler is opened by moving the housing in a translational motion in the distal direction across the body from the closed configuration, and an inhaler loading for inserting or removing a cartridge direction, and is opened to insert or remove a cartridge and / or realize the extraction position. With the cartridge installed in the inhaler, the translational movement of the housing from the distal to the proximal direction along the body causes the movement of the cartridge from the containment form to the dosing form, and the cartridge container is pushed into the dosing form by a protrusion configured inside the housing extending beyond the opening at the proximal end. In the closed form, the cartridge installed in the inhaler is reconfigured to form an additional air passage with the mouthpiece and the surrounding air so as to access the dry powder in the cartridge in the dosing form. In this embodiment and other embodiments, the air passage of the cartridge in the dosing form has an air inlet and an air outlet communicating with the air passage in the mouthpiece, and the mouthpiece has its own air inlet and air outlet. In some embodiments, the body of the inhaler includes a mouthpiece formed at the proximal end of the body and has an air duct communicating with the inside of the housing, and can communicate directly with the exhaust port of the cartridge installed in the inhaler and the surrounding air. The inhaler body also includes a cartridge mounting area whose structure is continuous with the mouthpiece and has a distal portion and a proximal portion; the proximal portion and the distal portion form a single piece with the mouthpiece and can be inserted into the housing. In some embodiments, the body and the housing can be separated to realize an open form of the inhaler for accessing the internal compartment. In the open form of this embodiment, the cartridge containing the dry powder can be loaded or installed in the cartridge mounting area of the body, and the body and the housing can be pushed or pulled to open or close the inhaler. In the closed form, the cartridge installed in the inhaler is reconfigured to form an additional air passage with the mouthpiece and the surrounding air so as to access the dry powder in the cartridge in the dosing form. In this embodiment and other embodiments, the air passage of the cartridge in the dosing form has an air inlet and an air outlet communicating with the air passage in the mouthpiece, and the mouthpiece has its own air inlet and air outlet. In the closed form, the cartridge installed in the inhaler is reconfigured to form an additional air passage with the mouthpiece and the surrounding air so as to access the dry powder in the cartridge in the dosing form. In this embodiment and other embodiments, the air passage of the cartridge in the dosing form has an air inlet and an air outlet communicating with the air passage in the mouthpiece, and the mouthpiece has its own air inlet and air outlet. In some embodiments, the body of the inhaler includes a mouthpiece formed at the proximal end of the body and has an air duct communicating with the inside of the housing, and can communicate directly with the exhaust port of the cartridge installed in the inhaler and the surrounding air. The inhaler body also includes a cartridge mounting area whose structure is continuous with the mouthpiece and has a distal portion and a proximal portion; the proximal portion and the distal portion form a single piece with the mouthpiece and can be inserted into the housing. In some embodiments, the body and the housing can be separated to realize an open form of the inhaler for accessing the internal compartment. In the open form of this embodiment, the cartridge containing the dry powder can be loaded or installed in the cartridge mounting area of the body, and the body and the housing can be pushed or pulled to open or close the inhaler. In the closed form, the cartridge installed in the inhaler is reconfigured to form an additional air passage with the mouthpiece and the surrounding air so as to access the dry powder in the cartridge in the dosing form. In this embodiment and other embodiments, the air passage of the cartridge in the dosing form has an air inlet and an air outlet communicating with the air passage in the mouthpiece, and the mouthpiece has its own air inlet and air outlet. In the closed form, the cartridge installed in the inhaler is reconfigured to form an additional air passage with the mouthpiece and the surrounding air so as to access the dry powder in the cartridge in the dosing form. In this embodiment and other embodiments, the air passage of the cartridge in the dosing form has an air inlet and an air outlet communicating with the air passage in the mouthpiece, and the mouthpiece has its own air inlet and air outlet.

[0039] In some embodiments, the body of the inhaler includes a mouthpiece formed at the proximal end of the body and has an air duct communicating with the inside of the housing, and can communicate directly with the exhaust port of the cartridge installed in the inhaler and the surrounding air. The inhaler body also includes a cartridge mounting area whose structure is continuous with the mouthpiece and has a distal portion and a proximal portion; the proximal portion and the distal portion form a single piece with the mouthpiece and can be inserted into the housing. In some embodiments, the body and the housing can be separated to realize an open form of the inhaler for accessing the internal compartment. In the open form of this embodiment, the cartridge containing the dry powder can be loaded or installed in the cartridge mounting area of the body, and the body and the housing can be pushed or pulled to open or close the inhaler. In the closed form, the cartridge installed in the inhaler is reconfigured to form an additional air passage with the mouthpiece and the surrounding air so as to access the dry powder in the cartridge in the dosing form. In this embodiment and other embodiments, the air passage of the cartridge in the dosing form has an air inlet and an air outlet communicating with the air passage in the mouthpiece, and the mouthpiece has its own air inlet and air outlet. In some embodiments, the body of the inhaler includes a mouthpiece formed at the proximal end of the body and has an air duct communicating with the inside of the housing, and can communicate directly with the exhaust port of the cartridge installed in the inhaler and the surrounding air. The inhaler body also includes a cartridge mounting area whose structure is continuous with the mouthpiece and has a distal portion and a proximal portion; the proximal portion and the distal portion form a single piece with the mouthpiece and can be inserted into the housing. In some embodiments, the body and the housing can be separated to realize an open form of the inhaler for accessing the internal compartment. In the open form of this embodiment, the cartridge containing the dry powder can be loaded or installed in the cartridge mounting area of the body, and the body and the housing can be pushed or pulled to open or close the inhaler. In some embodiments, the body and the housing can be separated to realize an open form of the inhaler for accessing the internal compartment. In the open form of this embodiment, the cartridge containing the dry powder can be loaded or installed in the cartridge mounting area of the body, and the body and the housing can be pushed or pulled to open or close the inhaler. In some embodiments, the body of the inhaler includes a mouthpiece formed at the proximal end of the body and has an air duct communicating with the inside of the housing, and can communicate directly with the exhaust port of the cartridge installed in the inhaler and the surrounding air. The inhaler body also includes a cartridge mounting area whose structure is continuous with the mouthpiece and has a distal portion and a proximal portion; the proximal portion and the distal portion form a single piece with the mouthpiece and can be inserted into the housing. In some embodiments, the body and the housing can be separated to realize an open form of the inhaler for accessing the internal compartment. In the open form of this embodiment, the cartridge containing the dry powder can be loaded or installed in the cartridge mounting area of the body, and the body and the housing can be pushed or pulled to open or close the inhaler. be released or be capable of being released. In some embodiments, the housing is movable over the upper side of the distal portion of the body and together closes the inhaler to form an air duct through the cartridge mounted in the cartridge mounting area. In this form, the inhaler realizes a dosage form for the powder in the cartridge such that when orally inhaled by a user using the mouthpiece, it is released from the inhaler. In this embodiment and dosage form, the body and the housing abut against each other and are properly fitted firmly by one or more anti-slip structures so that the inhaler does not come apart. Examples of anti-slip features are snap rings or detents, which can generate sounds to alert the user that the inhaler is ready for use. In some embodiments, the inhaler is substantially rectangular, with short lengths of the distal and proximal sides; the movement of the housing over the body or vice versa is also caused by pulling or pushing an inhaler body having guide rails or tracks extending outward from the longer sides (the first side and the second side) of the inhaler in the longitudinal plane. In this embodiment, the inhaler body is designed to have an opening at its distal end that fits into the opening at the distal end of the housing so that when inhaling, ambient air can be guided into the inner chamber of the inhaler. The housing also has grooves or slots for sliding over the guide rails during movement and is configured to fit precisely, and also includes a stop end to prevent disassembling of the inhaler and a pusher for positioning the cartridge in the dosage form and closing the inhaler after installation. The pusher moves the cap or container of the cartridge relative to the lid of the cartridge to open the air passage through the cartridge. is movable over the upper side of the distal portion of the body and together closes the inhaler to form an air duct through the cartridge mounted in the cartridge mounting area. In this form, the inhaler realizes a dosage form for the powder in the cartridge such that when orally inhaled by a user using the mouthpiece, it is released from the inhaler. In this form, the inhaler realizes a dosage form for the powder in the cartridge such that when orally inhaled by a user using the mouthpiece, it is released from the inhaler. In this embodiment and dosage form, the body and the housing abut against each other and are properly fitted firmly by one or more anti-slip structures so that the inhaler does not come apart. In this embodiment and dosage form, the body and the housing abut against each other and are properly fitted firmly by one or more anti-slip structures so that the inhaler does not come apart. Examples of anti-slip features are snap rings or detents, which can generate sounds to alert the user that the inhaler is ready for use. Examples of anti-slip features are snap rings or detents, which can generate sounds to alert the user that the inhaler is ready for use. In some embodiments, the inhaler is substantially rectangular, with short lengths of the distal and proximal sides; the movement of the housing over the body or vice versa is also caused by pulling or pushing an inhaler body having guide rails or tracks extending outward from the longer sides (the first side and the second side) of the inhaler in the longitudinal plane. In this form, the inhaler realizes a dosage form for the powder in the cartridge such that when orally inhaled by a user using the mouthpiece, it is released from the inhaler. In this form, the inhaler realizes a dosage form for the powder in the cartridge such that when orally inhaled by a user using the mouthpiece, it is released from the inhaler. In this embodiment, the inhaler body is designed to have an opening at its distal end that fits into the opening at the distal end of the housing so that when inhaling, ambient air can be guided into the inner chamber of the inhaler. In this embodiment, the inhaler body is designed to have an opening at its distal end that fits into the opening at the distal end of the housing so that when inhaling, ambient air can be guided into the inner chamber of the inhaler. The housing also has grooves or slots for sliding over the guide rails during movement and is configured to fit precisely, and also includes a stop end to prevent disassembling of the inhaler and a pusher for positioning the cartridge in the dosage form and closing the inhaler after installation. The housing also has grooves or slots for sliding over the guide rails during movement and is configured to fit precisely, and also includes a stop end to prevent disassembling of the inhaler and a pusher for positioning the cartridge in the dosage form and closing the inhaler after installation. The housing also has grooves or slots for sliding over the guide rails during movement and is configured to fit precisely, and also includes a stop end to prevent disassembling of the inhaler and a pusher for positioning the cartridge in the dosage form and closing the inhaler after installation. The pusher moves the cap or container of the cartridge relative to the lid of the cartridge to open the air passage through the cartridge. The pusher moves the cap or container of the cartridge relative to the lid of the cartridge to open the air passage through the cartridge. is formed and an air inlet and an air outlet are created, and an aerosol of the powder in the cup is enabled to be atomized to deliver the atomized particles to the inhaler mouthpiece and the user. In another embodiment, the pusher also moves the cartridge assembly to position the lid relative to the inlet opening located on the floor of the mouthpiece. In one aspect of this embodiment, the dry powder inhaler includes a housing that includes a pusher, and the housing positions the cartridge in alignment with the mouthpiece by translating the housing from an open configuration to a closed configuration across the inhaler body.

[0040] In some embodiments, the dry powder inhaler includes a housing having a distal end and configured with an opening that communicates with the ambient air. In some embodiments, the housing is configured in the form of a cover that slides over the upper side of the inhaler body and substantially covers a portion of the inhaler body, and the housing translates over the upper side of the distal portion of the body; the inhaler can achieve two configurations, a first position where the inhaler is opened to access its internal compartment, chamber; and a second position where it abuts against the proximal end to effect closure of the inhaler. In some embodiments, the distal portion of the housing is also movable in a horizontal plane relative to the proximal end, extends in a distal direction to provide access to the internal compartment of the inhaler and surrounds the inhaler body over its upper side. In multiple versions of this embodiment, the distal portion of the housing includes a parallel structure or flange for engaging a plurality of portions of the inhaler body and, for example, locks the inhaler body with the housing and secures the two components togetherA fixing mechanism for maintaining the drug form is formed. In certain embodiments, the distal portion of the housing has, at its distal end, an opening for communicating with the interior of the inhaler and an opening configured to slide on the inhaler body . The distal portion of the housing also includes an outer surface, an inner surface, and a chamber configured to slide on the inhaler body. In some embodiments, the distal portion of the inhaler includes a structure like parallel wings on its upper surface for directing airflow into the mouthpiece during inhalation .

[0041] In an alternative embodiment, the mouthpiece is engaged with the body of the inhaler by various mechanisms including movable members such as hinges, and is integrally configured by a movable assembly including a rack for moving the lid of the cartridge relative to the cup or container of the cartridge . The movable assembly is configured to receive and reconfigure the cartridge installed in the inhaler from a containment position to a dosing position, and can be designed to operate manually or automatically when components of the inhaler move, for example, by opening or closing the device . In some embodiments, the mechanism for reconfiguring the cartridge includes a slide tray or sled attached to the mouthpiece and movably attached to the housing. In another embodiment , the mechanism includes a geared mechanism attached or adapted to the inhaler and integrally attached, for example, within the hinge of the inhaler . In yet another embodiment, the mechanism operably configured to receive and reconfigure the cartridge from a containment position to a dosing position includes, for example, a cam that can reconfigure the cartridge when the housing or the mouthpiece rotates. In some embodiments, rotation of the mouthpiece by an angular amount from the horizontal plane opens the inhaler to expose the cartridge . . In another embodiment, the mechanism is attached or adapted to the inhaler and includes, for example, a geared mechanism integrally attached within the hinge of the inhaler . In yet another embodiment, the mechanism operably configured to receive and reconfigure the cartridge from a containment position to a dosing position includes, for example, a cam that can reconfigure the cartridge when the housing or the mouthpiece rotates. In some embodiments, rotation of the mouthpiece by an angular amount from the horizontal plane opens the inhaler to expose the cartridge . In some embodiments, rotation of the mouthpiece by an angular amount from the horizontal plane opens the inhaler to expose the cartridge ​​Allows for the installation or removal of the trigger and enables angular movement of the mouthpiece from a vertical plane to a horizontal plane, while closing the mouthpiece and allowing for automatic reconfiguration of the cartridge from a containment position to a dosing position. In some embodiments, the operating gear mechanism positions the lid of the cartridge relative to the inlet opening in the mouthpiece and translates the cup to the dosing configuration.

[0042] In some embodiments, an inhaler used by a subject is provided to the subject, and the patient inhalation profile is determined using an inhaler accessory device adapted to the inhaler by prompting the subject to breathe using the inhaler mouthpiece by activating the inhalation device and system. Simultaneously with the patient's breathing, the inhaler accessory device either performs a display of data detected and monitored by the system, or an indicator regarding such data is generated in real time from the patient's breathing. In this and other embodiments, the display can be viewed on a mobile phone, tablet, PDA, or computer including an algorithm application, which communicates with a microprocessor on the inhaler accessory device including a microwave radio signal transmitter and receiver, or transceiver, such as Bluetooth®, Zigbee®, WiFi, SmartWave, Z-Wave, or a digital cellular network such as 4G and 5G, and the microwave radio signal can be detected by an application provided on a mobile phone that can communicate with the inhaler accessory device. In some embodiments, the microwave radio signals from the transceiver can be transmitted from the microprocessor for communication with each other and with a transceiver in a computer. It can be received by a machine. In an embodiment where the accessory device for the inhaler communicates with a tablet, a personal digital assistant (PDA), or a mobile phone, the tablet, PDA, or mobile phone can access a programmed application, thereby displaying it graphically on a screen. When the switch is turned on, it can communicate with the accessory device for the inhaler and detect any information / signals generated from the inhalation stem. In an embodiment where it communicates with a tablet, PDA, or mobile phone, the tablet, PDA, or mobile phone can access a programmed application, thereby displaying it graphically on a screen. When the switch is turned on, it can communicate with the accessory device for the inhaler and detect any information / signals generated from the inhalation stem. thereby displaying it graphically on a screen. When the switch is turned on, it can communicate with the accessory device for the inhaler and detect any information / signals generated from the inhalation stem. thereby displaying it graphically on a screen. When the switch is turned on, it can communicate with the accessory device for the inhaler and detect any information / signals generated from the inhalation stem.

Brief Description of the Drawings

[0043]

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[0044] The present specification relates to a method for preventing pressure or pressure drop and / or airborne particles from entering the subject during an inhalation maneuver using an inhaler. an interactive system for measuring or monitoring real-time changes in characteristics of the stream; A device and / or instrument and method are disclosed. The instrument, in conjunction with an inhaler, controls the breathing of a subject. In order to maximize the efficiency of the and also to ensure proper dose delivery, timing of dose delivery, and proper functioning of the inhalation system during use. It may be used to monitor inhalation during drug delivery to detect proper performance. In one embodiment, the sensing and monitoring device can be applied in combination with a high resistance inhaler. As described herein In an embodiment, the detection and monitoring system can measure a number of characteristic parameters of the inhalation operation, particularly in combination with a dry powder inhaler, for the inhaler and the characteristic parameters include the peak inhalation effort (PIP2) within 2 seconds of the start of inhalation, the total inhalation effort (AUC1) in the first second of inhalation, the total inhalation volume, and data generated to evaluate the duration of inhalation of the patient's inhalation effort including. The handheld inhaler system is described as including two parts - an inhaler and an inhaler accessory device, but those skilled in the art will appreciate that during the inhalation operation, for measuring or monitoring data and characteristics The design of the present invention of this system and method can also be applied to devices in which the accessory features are integrated into the inhaler itself, despite sacrificing flexibility and reusability can be understood. The device includes an inhaler accessory device adapted to be attached to the inhaler or otherwise associated therewith. The device includes at least one transducer or sensor, which detects at least one measurement value including pressure, air flow, air volume, humidity, and temperature, and can convert them into electrical signals. In some embodiments, the sensor can include a Doppler sensing device that can detect the flow of air or gas through the inhaler

[0045] In other embodiments, the sensor includes a pressure sensor that can detect the pressure drop during the inhalation operation. The inhaler accessory device further includes appropriate signal conditioning circuits such as signal filtering, amplification, and analog-to-digital conversion, and transfers the generated signal to a computer or a portable information terminal (PDA) for receiving simultaneously or in real time, for example, a mobile phone for displaying the signal or the processed information for transfer. In some embodiments, the sensor may include a Doppler sensing device that can detect the flow of air or gas through the inhaler. In other embodiments, the sensor includes a pressure sensor that can detect the pressure drop during the inhalation operation. The inhaler accessory device further includes appropriate signal conditioning circuits such as signal filtering, amplification, and analog-to-digital conversion, and a computer or a portable information terminal (PDA) for receiving the generated signal simultaneously or in real time, for example, a mobile phone for displaying the signal or the processed information, for transfer therefor. including a processing circuit such as a microprocessor, a wired or wireless communication interface, etc. It may include an electronic board with circuit elements. In some embodiments, the output display can be an interactive display, so the display device provides visual assistance that enables a physician and / or patient to view the acquired inhalation operation parameters. In this way, the obtained information can serve as guidelines for performing repeatable inhalation operations in real time, thereby enabling appropriate inhalation delivery of the drug during self-administration. In another exemplary embodiment, the data can be stored for later analysis. .

[0046] Figures 1 - 7 show embodiments of a dry powder inhaler system or training device and its components. The interactive system of the training device described herein is adapted to high resistance dry powder inhalers such as those disclosed in U.S. Patent No. 8,499, 757, U.S. Patent No. 8,636,001, and U.S. Provisional Patent Application No. 62 / 289,095, and is incorporated herein by reference in their entirety as they relate to dry powder inhalers.

[0047] Figures 1 and 2 show wireless and wired inhalation detection and monitoring systems 10, 12, respectively. The system includes an inhaler 14 that includes a mouthpiece 15 having an air conduit 16 for delivering powder to a user / patient and an exhaust port 1 7. The inhalation detection and monitoring systems 10, 12 also include an inhaler accessory 18 adapted to be attached to, connected to, or otherwise associated with the inhaler 14. In this embodiment, the inhaler accessory is a It includes an operation button 19 for turning the power of the stems 10 and 12 on / off. An air duct is established between one or more intake ports to establish an air duct path through the system, and at least one air duct path passes through a container containing dry powder for delivery to an individual during use. In some embodiments, the inhaler contains no powder at all during training of the patient regarding the proper use of the inhaler. In the embodiments of FIGS. 1 and 2, the inhaler 14 is of the same type, a dry powder inhaler, and the inhaler accessory device 1 8 is adaptable to the top surface of the inhaler 14. FIG. 2 shows an inhaler accessory device 18 having an electric wire 22 connected to the system for connection to a power source and / or a computer.

[0048] FIG. 3 shows a top side isometric view of another embodiment of an inhaler accessory device 24 designed to fit the inhaler. FIG. 4 shows a bottom side isometric view of the device 24. As shown in FIGS. 3 and 4, the accessory device 24 preferably includes a body having tabs 25, 25' for attachment to the inhaler. However, other types of fixing devices known to those skilled in the art may be used to engage the device with the inhaler. The device 24 also preferably includes an operation button 26 for activating the device for use. In this embodiment, the body has a top surface 27, a bottom surface 28, and an electronic board 30 mounted on the bottom surface. FIG. 4 shows an embodiment of the inhaler accessory device 24 having an electronic board 30 integrally incorporated into its lower surface 28. FIGS. 4 and 5 further show the electronic board 30. The electronic board 30 preferably has an actuator 26', a sensor 29, and a microprocessor mechanically or otherwise connected to the operation button 26. ​​​​​​It includes a microprocessor 32. The microprocessor 32 provides for the activation, detection, processing, and communication of information / signals to a display device of signals from a relevant inhaler. In this embodiment, the electronic board 30 is configured as a signal processing / interface board. The sensor 29 can be any type of sensor, such as an acoustic sensor for detecting sounds generated during inhalation or a pressure sensor for detecting a pressure drop during inhalation. The inhaler accessory device 24 also preferably includes a battery as a power source for starting the system when an activation button is pressed. Those skilled in the art will understand that the electronics included in the inhaler accessory device 24 can be provided as separate circuit components on separate boards connected by appropriate means necessary for the functions. For example, the microprocessor 32 can be present on a board separate from the sensor 29 due to the need for the placement of the sensor 29.

[0049] In another embodiment, the inhalation detection / monitoring system includes indicators as shown in FIGS. 6 and 7. FIG. 6 shows an isometric view of a dry powder inhaler coupled to an inhaler accessory device as shown in FIG. 1, showing signal indicators 35, 36. FIG. 7 shows an isometric view of a dry powder inhaler coupled to an inhaler accessory device 18 as shown in FIG. 2, showing signal indicators 35, 36. The signal indicators 35, 36 are preferably light-emitting diodes or other optical indicators for indicating certain statuses to the user. For example, the signal indicator can be used to indicate whether inhalation has resulted in successful drug inhalation. In this case, for example, during operation, one indicator can indicate a red signal light, and another indicator can be used to indicate whether inhalation has resulted in successful drug inhalation. In this case, for example, during operation, one indicator can indicate a red signal light, and another indicator ​​​​​​​​​​​The indicator can indicate a green signal light. The signal indicators 35, 36 display to the user in response to non - compliance or compliance regarding the effective delivery of the powder in the inhaler for the treatment of the disease. The non - compliance inhalation indicator (red light) indicates that the inhalation operation of the subject or patient has not met one or more predetermined criteria regarding the inhalation of the powder dose contained in the inhaler, and the compliance inhalation indicator (green light) indicates that the inhalation operation of the subject or patient has met the appropriate criteria for delivering the powder dose contained in the inhaler. Alternatively, if the color can be selected based on the status, or, for example, if blinking can be used to indicate the status, only one of the signal indicators can be used. The signal indicators 35, 36 can be positioned anywhere within the housing to facilitate visual perception by the user. In another embodiment, an LED signal can also be integrated into the inhalation accessory device and used to indicate the quality of the inhalation operation. For example, a continuous red light indicator can inform the user that the inhalation was non - compliant and that in subsequent attempts, the inhalation needs to be done more firmly, deeper, or faster. In one embodiment, a flashing red light indicator can inform the user that the inhalation was non - compliant and that subsequent inhalations need to be done for a longer period. In this and other embodiments, a continuous green light indicator

[0050] indicates that the inhalation was compliant or that the delivery of the contents of the dry powder inhaler to the subject during inhalation was acceptable. Other uses of the signal indicators 35, 36 are for power ON / OFF, power abnormality or low battery indication, or connection status between the accessory device and the inhaler. between the accessory device and the inhaler. may include data.

[0051] In an alternative embodiment, the inhalation detection and monitoring system includes an annunciator that reports the quality of the inhalation operation. The system includes an indicator that includes an annunciator. In this embodiment, the annunciator is optionally provided to be activated separately and is particularly suitable for users with visual impairments.

[0052] FIG. 8 shows an isometric view of an alternative embodiment of a wireless dry powder detection and sensing inhalation system 12, where an inhaler attachment device 42 is attached to an inhaler 14 and is configured integrally with a display screen 44 formed on the main body portion of the attachment device 42 so that a patient's inhalation effort can be visualized simultaneously with the patient's inhalation operation. In this embodiment, the inhaler attachment device 42 includes an electronic board 30 as shown in FIGS. 4 and 5, where signal information regarding the inhaler is processed in a microprocessor 32, and the resulting processed information is communicated to the display screen 44 and preferably presented as a graphical display compared to one or more predetermined criteria for the inhaler being used. This graph and associated data points are preferably stored locally on the electronic board 30 but may also be stored remotely. In this and other embodiments, the predetermined criteria for the inhaler depend on the inhaler and drug in use. In some of the embodiments shown in the drawings of this specification, the criteria used are, as described above, peak inspiratory pressure, dose delivered, etc.

[0053] FIGS. 9, 10, and 11 illustrate various operations of the inhalation detection and monitoring system shown in FIGS. 1-8. shows an embodiment. FIG. 9 shows an overall implementation of the wireless detection and monitoring system 50 disclosed herein in the form of a block diagram. In FIG. 9, the system 50 includes two components, an accessory device 54 and a processing system 56. In this embodiment, the inhaler accessory device 54 includes an electronic board that has two sensors 51, 52, a battery 53, a microprocessor 7 0, and a wireless communication device or transceiver 72. The analog sensor 51 and the digital sensor 52 are arranged to be close to the inhaler airflow conduit so that when the inhalation detection and monitoring system 10, 12 is activated or switched on, a sound signal or a pressure difference within the inhaler 14 can be detected. The system is similarly powered by pressing activation buttons 19, 26 connected to a power source, such as a battery 53, that powers the system. Alternatively the system can be powered by an electric wire, such as a USB port. The sensors 51, 52 are preferably arranged at any point within or proximate to the air conduit of the inhaler accessory devices 18, 24. In some exemplary embodiments, the sensors 18, 24 can be arranged within the body 20 of the accessory device or within the air conduit near the mouthpiece 15 of the inhaler in use.

[0054] The processing system 56 can include a PDA, a tablet, a mobile phone, or a computer 57, a display 58, a wireless communication device 59, and an output unit 55 that can be in the form of digital storage, a web interface, a print out, or an email, etc. Those skilled in the art will understand that the display 58, the wireless communication device 59, and the output unit 55 are not separate elements but can simply exist within the PDA / tablet / mobile phone / computer 57. It should be understood that In an exemplary embodiment, the user can activate the accessory device 54 for the inhaler by pressing a power button, for example, button 19 of device 10, thereby also activating the processing system 56. When the computer 57 preferably includes an algorithm in the form of software application or program designed to collect and display inhalation effort. When the software program integrated with the computer 57 is started, a start signal appears on the display 58. In the activated state of the system, due to the user's inhalation 60, a pressure drop occurs in the inhaler training device 50, which is converted into an electrical signal by one or more of the sensors 51, 52. In this embodiment, the sensors 51, 52 can be pressure, flow, sound, light, gas, humidity, or temperature transducers, either analog or digital. Thereafter, the electrical signal generated from the sensor 51 is transmitted to the signal conditioner 61 to remove unwanted parts of the signal, such as signal noise. Thereafter, the conditioned electrical signal 62 is transmitted to the band limiter 63 to narrow the frequency of the signal to the desired range, reduce and select the data that needs to be analyzed, and then the signal is transmitted to the signal amplifier 64. In the signal amplifier 64, the selected signal is amplified to a predetermined voltage range and can be transmitted as the amplified signal 65. Thereafter, the amplified signal 65 is converted into a digital signal 67 by the analog-to-digital converter 66. Those skilled in the art should understand that certain "smart" sensors incorporating some of the functions of conditioning, filtering, amplification, and conversion into the sensor itself can be used. Therefore, any reference to these subsequent elements in this specification also contemplates the use of such integrated sensors. ​ can be replaced. Therefore, the digital signal 67 is received by the microprocessor 70 and transmitted to the wireless communication device or transceiver 72, which has a wireless communication device 59 for receiving a wireless (e.g., Bluetooth) signal 69 and is designed to transmit using a wireless technology standard such as Bluetooth via the connection part 74 to a computer 57 that transmits to a computer 57 having a wireless communication device 59 for receiving a wireless (e.g., Bluetooth) signal 69. A software program incorporated / programmed in the microprocessor 70 or the computer 57 smoothly progresses the basic functions within the inhaler accessory device, including notifying of the presence of wireless, linking to the wireless communication device or transceiver 59, and passing data via the wireless signal 69 from element to element. The program also converts the electrical signals from the sensors 1, 2 into pressure values, which can be displayed on the graph display 58. The display 58 can be a screen including an LED, OLED, LCD, touch screen, or other interactive display. In some embodiments, a baseline curve for the user is stored in the system 50 and provided to the display 58 along with the inhalation signal information. The baseline curve represents the level of performance of the inhaler type for delivering a substantially accurate dose to the patient when measured using the inhaler training device 10 as a reference standard for guiding the user's inhalation operation. Therefore, during inhalation, the user can visually compare the user's inhalation operation to the baseline standard. While training the user, the drug can When it is, the user's inhalation effort is changed to match the standard requirements. Depending on the subject For each inhalation performed by the subject, the data displayed is output to the output unit 55 via the second connection part 76 and can be stored here, where the data can be appropriately stored or transferred. For example, the output unit 55 can be in the form of a disk drive, a flash drive, or a printer, or can be transferred to a doctor via email or text for further consideration or training as needed. In some embodiments, signals from the inhalation training device can be transmitted to a computer / PDA / mobile / tablet, and signals from the computer / PDA / mobile / tablet can be received by the inhalation training device, thereby establishing two-way communication between the two components. For example, the user can input certain information into the computer 57, such as a patient number, dosage strength, comments on the condition, etc. In this embodiment and other embodiments, the sensor 52 is a digital sensor, that is, a sensor that can produce a digital output. The sensor can be an accelerometer, a Doppler sensor, an illuminometer, or a laser, and the detected signal can be directly transmitted to the built-in microprocessor and then analyzed, processed, and transmitted. The signal information in the microprocessor can be analyzed and processed using, for example, an algorithm that converts the data into a pressure-versus-time curve using a graphical interface, and this can be displayed. The signal from the sensor 52 can convey information regarding flow, pressure difference, etc., and this information is different from the signal in the sensor 51 when both sensors 51 and 52 are used.

[0055] ​​​​​Furthermore, other mounted devices 78 can transmit data via one or more cables 79 and receive data from the microprocessor 70. For example, other mounted devices may include digital output sensors, temperature sensors, light-emitting diodes (LEDs), warning sound devices, and other mounted sensors. These mounted devices can be used to output pass / fail criteria for inhalation operations through such pass / fail LED lights or audible indicators. Temperature, humidity, or other environmental data can be used to determine the environment in which the inhaler was used. With respect to the output of the sensor 51 following signal amplification, the amplified signal 65 can instead be directly transmitted to the computer 57 via the wireless communication device 72, and the computer can perform analog-to-digital conversion and other necessary analysis steps. Figure 10 shows a block diagram of an embodiment of the detection and monitoring system disclosed in Figure 8 with an integrated display. The inhalation detection and sensing device 82 includes a mounted electronic system with an integrated display 84 and a microprocessor 86; and an inhaler accessory device including an analog sensor 88 and a digital sensor 89. When in use, the system is activated by the user 90 pressing the activation button 19 and is powered by the battery 92. When the user inhales using an inhaler adapted to the inhaler accessory device 82 including the mounted electronic system, one or more of the sensors 88, 89 generate a signal, which is transmitted to the microprocessor 86. For example, an acoustic sensor or microphone 88 can be used to generate an electrical signal 94, which is transmitted to a signal conditioner 96 to remove excessive noise.

[0056]

[0057] ​​​​​​​​​​​​​​​​ It is then sent to a band limiter 98 to narrow the frequency of the signal to a desired range, reducing the data that needs to be analyzed. The signal is then sent to a signal amplifier 95, where the signal is amplified and sent to an analog-to-digital converter 97, and the digital signal is communicated to an on-board microprocessor 86 to analyze the information, convert it into a graph, and send it to a display 84 for visualization. A sensor 89, which is a digital sensor, can be used instead of or in combination with sensor 88 to detect a signal and generate a set of signals for sending to the microprocessor 86. Similarly, in the microprocessor, the signal is sent for analysis, storage, and to a display 82. Other devices 99, including other sensors, can also be included to detect other parameters of the inhaler or system. narrowed to reduce the data that needs to be analyzed, and then the signal is sent to a signal amplifier 95, where the signal is amplified and sent to an analog-to-digital converter 97, and the digital signal is communicated to an on-board microprocessor 86 to analyze the information, convert it into a graph, and send it to a display 84 for visualization. A sensor 89, which is a digital sensor, can be used instead of or in combination with sensor 88 to detect a signal and generate a set of signals for sending to the microprocessor 86. Similarly, in the microprocessor, the signal is sent for analysis, storage, and to a display 82. Other devices 99, including other sensors, can also be included to detect other parameters of the inhaler or system. led, where the signal is amplified and sent to an analog-to-digital converter 97, and the digital signal is communicated to an on-board microprocessor 86 to analyze the information, convert it into a graph, and send it to a display 84 for visualization. A sensor 89, which is a digital sensor, can be used instead of or in combination with sensor 88 to detect a signal and generate a set of signals for sending to the microprocessor 86. Similarly, in the microprocessor, the signal is sent for analysis, storage, and to a display 82. Other devices 99, including other sensors, can also be included to detect other parameters of the inhaler or system. led signal is communicated to an on-board microprocessor 86 to analyze the information, convert it into a graph, and send it to a display 84 for visualization. A sensor 89, which is a digital sensor, can be used instead of or in combination with sensor 88 to detect a signal and generate a set of signals for sending to the microprocessor 86. Similarly, in the microprocessor, the signal is sent for analysis, storage, and to a display 82. Other devices 99, including other sensors, can also be included to detect other parameters of the inhaler or system. and sent to a display 84 for visualization. A sensor 89, which is a digital sensor, can be used instead of or in combination with sensor 88 to detect a signal and generate a set of signals for sending to the microprocessor 86. Similarly, in the microprocessor, the signal is sent for analysis, storage, and to a display 82. Other devices 99, including other sensors, can also be included to detect other parameters of the inhaler or system. -89 is used instead of or in combination with sensor 88 to detect a signal and generate a set of signals for sending to the microprocessor 86. Similarly, in the microprocessor, the signal is sent for analysis, storage, and to a display 82. Other devices 99, including other sensors, can also be included to detect other parameters of the inhaler or system. cessor 86, and in the microprocessor, the signal is similarly sent for analysis, storage, and to a display 82. Other devices 99, including other sensors, can also be included to detect other parameters of the inhaler or system. cessor 86, and in the microprocessor, the signal is similarly sent for analysis, storage, and to a display 82. Other devices 99, including other sensors, can also be included to detect other parameters of the inhaler or system. can also be included to detect other parameters of the inhaler or system.

[0058] FIG. 11 shows a block diagram of an embodiment of a detection and monitoring system 100 disclosed herein that includes a performance visual indicator that shows the operating part of the system rather than an integrated display. In this embodiment, two sensors, an analog sensor 101 and a digital sensor 102, are provided. When the system 100 is powered on by a battery 103, a patient / user 105 inhales and generates a signal such as sound from the airflow moving through the inhaler conduit. The sensors 101, 102 are activated to establish a signal from the inhaler and send the signal downstream; sensor 102 can be a Doppler that can receive an output signal that can be either analog or digital, for example, from airflow detection. If the output signals from sensor 102 are digital, they are sent to a microprocessor to analyze and process the input information. 101 and a digital sensor 102 are provided. When the system 100 is powered on by a battery 103, a patient / user 105 inhales and generates a signal such as sound from the airflow moving through the inhaler conduit. The sensors 101, 102 are activated to establish a signal from the inhaler and send the signal downstream; sensor 102 can be a Doppler that can receive an output signal that can be either analog or digital, for example, from airflow detection. If the output signals from sensor 102 are digital, they are sent to a microprocessor 101 and a digital sensor 102 are provided. When the system 100 is powered on by a battery 103, a patient / user 105 inhales and generates a signal such as sound from the airflow moving through the inhaler conduit. The sensors 101, 102 are activated to establish a signal from the inhaler and send the signal downstream; sensor 102 can be a Doppler that can receive an output signal that can be either analog or digital, for example, from airflow detection. If the output signals from sensor 102 are digital, they are sent to a microprocessor 101 and a digital sensor 102 are provided. When the system 100 is powered on by a battery 103, a patient / user 105 inhales and generates a signal such as sound from the airflow moving through the inhaler conduit. The sensors 101, 102 are activated to establish a signal from the inhaler and send the signal downstream; sensor 102 can be a Doppler that can receive an output signal that can be either analog or digital, for example, from airflow detection. If the output signals from sensor 102 are digital, they are sent to a microprocessor 101 and a digital sensor 102 are provided. When the system 100 is powered on by a battery 103, a patient / user 105 inhales and generates a signal such as sound from the airflow moving through the inhaler conduit. The sensors 101, 102 are activated to establish a signal from the inhaler and send the signal downstream; sensor 102 can be a Doppler that can receive an output signal that can be either analog or digital, for example, from airflow detection. If the output signals from sensor 102 are digital, they are sent to a microprocessor 101 and a digital sensor 102 are provided. When the system 100 is powered on by a battery 103, a patient / user 105 inhales and generates a signal such as sound from the airflow moving through the inhaler conduit. The sensors 101, 102 are activated to establish a signal from the inhaler and send the signal downstream; sensor 102 can be a Doppler that can receive an output signal that can be either analog or digital, for example, from airflow detection. If the output signals from sensor 102 are digital, they are sent to a microprocessor 101 and a digital sensor 102 are provided. When the system 100 is powered on by a battery 103, a patient / user 105 inhales and generates a signal such as sound from the airflow moving through the inhaler conduit. The sensors 101, 102 are activated to establish a signal from the inhaler and send the signal downstream; sensor 102 can be a Doppler that can receive an output signal that can be either analog or digital, for example, from airflow detection. If the output signals from sensor 102 are digital, they are sent to a microprocessor to analyze and process the input information.​ It is directly transmitted to the assessor 110. At the same time, the sensor 101 generates electrical signals, and these electrical signals are sensed within the inhaler and pass through a signal conditioner 106 for removing excessive noise. After that, the conditioned signal is transmitted to a band limiter 108 to select the data to be analyzed. Then, the limited signal is transmitted to a signal amplifier 109, where the signal is amplified and fed into an analog-to-digital converter 112. After that, the received signal is converted into a digital signal and transmitted to the on-board microprocessor, where it is analyzed and processed using an algorithm, thereby converting the data into, for example, visible or optical signals and displaying them as visible indicators, for example, green light or red light, to indicate whether the patient's inhalation effort is "qualified" i.e., whether the inhalation is by an appropriate effort to deliver the dry powder dose, or whether the patient's inhalation effort was insufficient to deliver the dry powder dose from the tested inhaler. In this embodiment, the other on-board device 115 can be integrated into a circuit, for example, other sensors, or a signal conditioner, amplifier, and A / D converter, depending on the type of sensor used. For example, the inhaler accessory can have two or more analog sensors, so the electrical signals need to pass through an A / D converter before being transmitted to the microprocessor for analysis and processing of the information. In an alternative embodiment, digital sensors can be used, and their output signals can communicate directly with the microprocessors 86, 110.

[0059] In other embodiments, the inhaler accessory can include a temperature sensor, a laser beam, a Doppler sensor, an illuminometer, a color sensor, text recognition, RFID, optical character recognition, optical identification, It may have one or more sensors including turn recognition, and the output signal thereof may be, for example, If it is not a digital signal output, it may be an analog signal output, and once these signals reach the microphone processor, they are converted into digital signals for further analysis and processing as necessary. These sensors are preferably included in an inhaler accessory device to identify which drug is loaded into the inhaler for administration and which cartridge type or dosage of such drug is loaded into the inhaler.

[0060] Figure 12 shows a screen shot of the tablet / computer / PDA / phone 57 of the processing system 56 of FIG. 9. The computer 57 is used to communicate remotely with the inhaler accessory device 54 using Bluetooth or another remote wireless technology, where the inhaler accessory device 54 is adapted to the inhaler, and the subject is required to inhale through the mouthpiece of the inhaler when the system is activated. The resulting graph on the screen, as shown in FIG. 12, plots the inhalatory effort on the y-axis in response to the inhalation operation, considering the sensor (e.g., pressure) measurements in seconds on the x-axis and the flow rate over time. The inhalatory effort by the subject is represented by curve A above the trapezoid B figure at the bottom of the graph . The outer limit of the trapezoid B (i.e., above the area) is interpreted as indicating the threshold or the minimum inhalatory effort that the subject needs to perform in order to effectively and consistently inhale the powder dose from the inhaler for expelling the contents of the powder in the inhaler when taking the dose . An identification sensor such as those described herein, located within the inhaler accessory device - detects data regarding the inhaler, drug type, dosage, lot, expiration date, etc., and transmits it. Such data is processed to identify the corresponding threshold data for display to the user. The trapezoid also represents the minimum characteristic criteria indicated by the inhaler, or the effort required for the inhaler to consistently deliver the dry powder dose, where the delivery rate is greater than 90 % for the patient. FIG. 12 graphically shows an exemplary display of an inhalation operation performed by a subject who is required to inhale deeply and can view the display screen on the tablet while performing the inhalation. As can be seen from such a curve, the subject generally performed within the acceptable values in region A.

[0061] Furthermore, FIG. 12 shows the baseline standard for inhalation behavior regarding the inhaler accessory device 10 and drug identification. The curve A detected by the user can be adjacent to the warning region just above region B and the acceptable or preferred region C above the warning region. Regions B and C and the warning region are provided in different colors to assist in the determination of those regions when monitoring the behavior of an individual during inhalation. Region B can be shown in, for example, red, indicating that the inhalation operation does not meet the baseline requirements; therefore, the delivery system is not optimal for effectively delivering the drug. The warning region can be shown in yellow, indicating a warning that the inhalation operation is approaching an unacceptable effort. The preferred region C can be shown in green, indicating that the inhalation behavior is within the acceptable effort for effectively delivering the drug. This display information detected from one or more sensors within the device is used by the clinician, physician, or user to determine whether appropriate dosing has occurred or what level of effort is necessary to ensure proper dosing of the drug. or how much effort is required to ensure proper dosing of the drug for the user. It can be determined whether it can be used to train.

[0062] Figures 13, 14 and 15 show various operations of the inhalation detection and monitoring system shown in Figures 1-8 Embodiments are shown. Figure 13 shows a block diagram of an overall embodiment of the wireless detection and monitoring system as disclosed herein. In Figure 13, system 120 includes two components, an inhaler training device or accessory 124, and a processing system 126. The processing system 126 includes a PDA, a mobile phone, or a computer 127, a display 128, a wireless communication device 129 , and an output unit 125 that can be in the form of digital storage, a web interface, printed matter, etc. In this exemplary embodiment, the user can activate the inhaler training device or apparatus 120 with the processing system 126 also being activated by pressing a power button, for example, button 19 on the training device 10. When a software program integrated with the computer 127 is started, a start signal appears on the display 128. In this embodiment , the accessory device 120 preferably includes an electronic board having two pressure sensors 121 and 122 arranged close to the inhaler air flow conduit, and when the operation buttons 19, 26 connected to a power source, for example, a battery 123 that supplies power to the system in a similar manner, are pressed to activate or switch on the devices 10, 12, the differential pressure from the inhaler and the absolute pressure of the environment from the inhaler 14 can be detected. When the system is activated, a pressure drop occurs within the inhaler training device 120 due to the user's inhalation 130, which is measured by the sensor 121. The absolute pressure sensor 122 relates to atmospheric conditions When a software program integrated with the computer 127 is started, a start signal appears on the display 128. In this embodiment , when a software program integrated with the computer 127 is started, a start signal appears on the display 128. In this embodiment , the accessory device 120 is preferably arranged close to the inhaler air flow conduit and includes an electronic board having two pressure sensors 121 and 122, and is connected to a power source, for example, a battery 123 that supplies power to the system in a similar manner. When the operation buttons 19, 26 are pressed to activate or switch on the devices 10, 12, the differential pressure from the inhaler and the absolute pressure of the environment from the inhaler 14 can be detected. When the system is activated, a pressure drop occurs within the inhaler training device 120 due to the user's inhalation 130, which is measured by the sensor 121. The absolute pressure sensor 122 relates to atmospheric conditions to be arranged close to the inhaler air flow conduit and includes an electronic board having two pressure sensors 121 and 122, and is connected to a power source, for example, a battery 123 that supplies power to the system in a similar manner. When the operation buttons 19, 26 are pressed to activate or switch on the devices 10, 12, the differential pressure from the inhaler and the absolute pressure of the environment from the inhaler 14 can be detected. When the system is activated, a pressure drop occurs within the inhaler training device 120 due to the user's inhalation 130, which is measured by the sensor 121. The absolute pressure sensor 122 relates to atmospheric conditions to be arranged close to the inhaler air flow conduit and includes an electronic board having two pressure sensors 121 and 122, and is connected to a power source, for example, a battery 123 that supplies power to the system in a similar manner. When the operation buttons 19, 26 are pressed to activate or switch on the devices 10, 12, the differential pressure from the inhaler and the absolute pressure of the environment from the inhaler 14 can be detected. When the system is activated, a pressure drop occurs within the inhaler training device 120 due to the user's inhalation 130, which is measured by the sensor 121. The absolute pressure sensor 122 relates to atmospheric conditions When the devices 10, 12 are activated or switched on by pressing the operation buttons 19, 26, the differential pressure from the inhaler and the absolute pressure of the environment from the inhaler 14 can be detected. When the system is activated, a pressure drop occurs within the inhaler training device 120 due to the user's inhalation 130, which is measured by the sensor 121. The absolute pressure sensor 122 relates to atmospheric conditions When the devices 10, 12 are activated or switched on by pressing the operation buttons 19, 26, the differential pressure from the inhaler and the absolute pressure of the environment from the inhaler 14 can be detected. When the system is activated, a pressure drop occurs within the inhaler training device 120 due to the user's inhalation 130, which is measured by the sensor 121. The absolute pressure sensor 122 relates to atmospheric conditions When the system is activated, a pressure drop occurs within the inhaler training device 120 due to the user's inhalation 130, which is measured by the sensor 121. The absolute pressure sensor 122 relates to atmospheric conditions and is measured by the sensor 121. The absolute pressure sensor 122 relates to atmospheric conditions Provide data or signals used to correct the differential pressure indication.

[0063] In this embodiment, sensors 121 and 122 are digital pressure sensors. Therefore, the signals generated by sensors 121 and 122 are transmitted to microprocessor 13 1 and wireless communication device 132. A software program incorporated / programmed in microprocessor 131 or computer 1 27 converts the signals generated by sensors 121 and 122 into (corrected) pressure values, which can be graphically displayed on display 58. This display can be a screen including an LED, OLED, LCD, touch screen lean, or other interactive display.

[0064] FIG. 14 shows a block diagram of an embodiment of the detection and monitoring system disclosed herein. The inhalation detection and sensing device includes an integrated or integrated display 144, a microprocessor 143 , and a mounted electronic system 140 including pressure sensors 141 and 142, and includes an accessory device for an inhaler. During use, the system is activated by user 146 and powered by battery 1 45. When the system is activated, a pressure drop occurs in the inhaler training device 140 due to the user's inhalation 146, which is measured by sensor 141. The absolute pressure sensor 142 provides data or signals used to correct the differential pressure indication regarding the atmospheric conditions. In this embodiment, sensors 141 and 142 are digital pressure sensors. When analog sensors are implemented, additional circuit elements are required for signal conditioning, filtering, amplification, and / or conversion as disclosed above. pressure sensors. When analog sensors are implemented, additional circuit elements are required for signal conditioning, filtering, amplification, and / or conversion as disclosed above. pressure sensors. When analog sensors are implemented, additional circuit elements are required for signal conditioning, filtering, amplification, and / or conversion as disclosed above. pressure sensors. When analog sensors are implemented, additional circuit elements are required for signal conditioning, filtering, amplification, and / or conversion as disclosed above. Therefore, the signals generated by the pressure sensors 141 and 142 are The microprocessor 143 is programmed to The programmed software program detects the signals generated by the sensors 141 and 142. into a (corrected) pressure value, which can be displayed graphically on the display 144, The display may be an LED, OLED, LCD, touch screen, or other interactive display. The screen may include a display.

[0065] FIG. 15 shows a block diagram of an embodiment of a detection and monitoring system disclosed herein. The inlet detection and sensing device includes an integrated visual indicator 154, a microprocessor 153, and The inhaler accessory includes an on-board electronic system 150 having pressure sensors 151 and 152 on the In use, the system is activated by a user 156 and powered by a battery 155. With the system activated, the user inhales 156 . A pressure drop occurs within the inhaler training device 150, which is measured by a sensor 151. The absolute pressure sensor 152 stores data that is used to correct the differential pressure reading for atmospheric conditions. In this embodiment, the sensors 151 and 152 provide digital pressure If an analog sensor is implemented, additional circuit elements are required as disclosed above. Such signal conditioning, filtering, amplification and / or conversion may be necessary. Therefore, the signals generated by the pressure sensors 151 and 152 are transmitted to a microprocessor The signal is transmitted to the microprocessor 153. The signal is embedded / programmed into the microprocessor 153. A software program converts the signals generated by the sensors 151 and 152 into is converted to a paid pressure value, which can be used to indicate accurate inhalation or other information can be used to activate the visual indicator 154.

[0066] FIG. 16 shows, for example, an inhaler training device, such as device 10, showing various additional operational components and further shows a block diagram thereof. In FIG. 16, system 160 includes two components , an inhaler training device or accessory device 164, and a processing system 166. The processing system 1 66 can be in the form of a tablet, PDA, mobile phone / smartphone, smartwatch, smart glass, or computer 167, a display 168, a wireless communication device 169, and an output unit 165 in the form of digital storage, a web interface, printed matter, etc. In this exemplary embodiment, the user can activate the inhaler training device 160 with the processing system 160 also activated by pressing a power button, for example, button 19 on the training device 10 . When a software program integrated into the computer 167 is started, a start signal appears on the display 168. With the system activated, a pressure drop occurs within the inhaler training device 160 due to the user's inhalation 170, which is measured by the sensor 161. In this embodiment, sensors 161 and 162 are digital pressure sensors. Therefore, signals generated by the color detection sensor 173 as well as the pressure sensors 161 and 162 are transmitted to the microprocessor 171 and the wireless communication device 172 . The software program incorporated / programmed in the microprocessor 171 or the computer 167 processes the signals generated by the color detection sensor 173 as well as the sensor 161 and 162. and transmitted to the microprocessor 171 and the wireless communication device 172 The software program incorporated / programmed in the microprocessor 171 or the computer 167 processes the signals generated by the color detection sensor 173 as well as the sensor 161 and 162. The signals generated by 162 are respectively converted into a cartridge information value and a pressure value , which can be graphically displayed on the display 168, and this display can be a screen including an LED, OL ED, LCD, touch screen, or other interactive display . The cartridge information value is used to provide a limit value regarding the effectiveness of the powder dosage and can be plotted as trapezoid B or other threshold displays on the graphical display (e.g . Figures 23, 24, 25, and 26). As mentioned in the above embodiments, in addition to the color detection device, other devices on the device board can include a laser, RFID, pattern or text / character reader or sensor, and are connected to the microprocessor in other ways to identify the inhaler, drug, or substance / drug cartridge / package. These sensors / readers function to provide data regarding the drug, substance, package, dosage, inhaler, etc. to the system and the microprocessor, so the corresponding data can be retrieved from storage and used as data points on any visual, audible, or other indicator including the graph shown to the user. As an example, certain types of ca rtridges or other packages can be color-coded or include encrypted or coded te xts, RFID indicating specific information about them, such as lot, expiration date, dosage, etc . A reader or sensor capable of detecting the code and transmitting corresponding data to the microprocessor for use in calculations identifies the action and data display . Perhaps a certain color of package indicates the use of a drug dosage that requires more effort to inhale properly . In this case, the accessory device or system is the sensor / reader . . . . Identify the appropriate color and use the appropriate data to instruct the user.

[0067] Figure 17 shows a block diagram of an embodiment of the detection and monitoring system disclosed herein. The inhalation detection and sensing device 180 includes an integrated or integrated display 184, a microprocessor 183, a color detection sensor 187, and pressure sensors 181 (differential pressure) and 182 (absolute pressure) including a mounted electronic system. During use, the system is operated by the user 186 and powered by the battery 185. When the system is activated, a pressure drop occurs within the inhalation device accessory due to the user's inhalation 186, which is measured by the sensor 181. The absolute pressure sensor 182 provides data or signals used to correct the differential pressure indication related to atmospheric conditions. In this embodiment, sensors 181 and 182 are digital pressure sensors. Therefore, the signals generated by the color detection sensor 187 and pressure sensors 181 and 182 are transmitted to the microprocessor 183. The software program incorporated / programmed in the microprocessor 183 converts the signals generated by the color detection sensor 187 and sensors 181 and 182 into cartridge information values and (corrected) pressure values, which can be graphically displayed on the display 184, which can be a screen including an LED, OLED LCD, touch screen, or other interactive display.

[0068] Figure 18 shows a block diagram of an embodiment of the detection and monitoring system disclosed herein. The inhalation detection and sensing device 190 includes an integrated visible indicator 194, a microprocessor 193 and includes a mounted electronic system having a color detection sensor 197 and pressure sensors 191 (differential pressure) and 192 (absolute pressure). The inhaler accessory device includes a system that, during use, is actuated by a user 196 and is powered by a battery 195. When the system is activated a pressure drop occurs within the inhaler accessory device due to the user's inhalation 196, which is measured by the sensor 191. The absolute pressure sensor 192 provides data or a signal used to correct for differential pressure indications related to atmospheric conditions. In this embodiment, the sensors 191 and 192 are digital pressure sensors. Accordingly, the signals generated by the color detection sensor 197 and the pressure sensors 191 and 192 are sent to a microprocessor 193. The software / firmware program incorporated / programmed in the microprocessor 193 converts the signals generated by the color detection sensor 197 and the sensors 191 and 192 into cartridge information values and (corrected) pressure values, respectively, which can be used to activate a visual indicator 194 that indicates failed inhalation or accurate / acceptable inhalation or other information.

[0069] FIG. 19 shows a flowchart diagram of an embodiment of a method 200 for detecting, monitoring, and training on an inhalation target by the system disclosed in FIG. 16. When a user uses the device and system the user activates and starts the system by pressing an actuator on the inhaler accessory device. Next, in step 202, the wireless communication mechanism of the inhaler accessory device uses, for example, standard Bluetooth technology to communicate with the user's smartphone ​​​​Link and the phone application display a ready message and prompt the user to load an associated inhaler to which the device is engaged or to provide a cartridge or other disposable package of the substance to be inhaled into the inhaler. In step 204 it is so loaded, the identification sensor, in this case color detection sensor 173, determines the color of the cartridge and stores it in the data storage on the accessory device board or transmits it via Bluetooth to the processing system 166 (phone) for storage. In step 2 06 the application displays a graph by the corresponding threshold data points provided based on color detection. Then in step 208 the user is prompted to inhale using some visual, audible or screen-based messages. S tep 210 during the inhalation operation sensors 161, 162 read the pressure drop. Next step 212 represents a correction step performed by the system based on the atmospheric conditions which occurs substantially simultaneously with or immediately after step 210. In either case the pressure data is stored as described above and preferably in step 214 is plotted on the graph. In step 216 the inhalation operation graph is displayed to the user together with the threshold graph indicating either pass (success of inhalation) or fail (failure of inhalation). At that time the user can press the actuator to end the program and the data remains stored in the output unit 165 for future use. In some exemplary embodiments disclosed herein, one or more key parameters are stored as described above and preferably in step 214 is plotted on the graph. In step 216 the inhalation operation graph is displayed to the user together with the threshold graph indicating either pass (success of inhalation) or fail (failure of inhalation). At that time the user can press the actuator to end the program and the data remains stored in the output unit 165 for future use. In some exemplary embodiments disclosed herein, one or more key parameters are

[0070] stored as described above and preferably in step 214 Total inhalation time, peak inspiratory pressure, time to peak inspiratory pressure, and average pressure from the peak of the total inhalation time to about 7 to 5% can define an acceptable inhalation operation. In some embodiments , the total inhalation time is from 0.1 second to 5 seconds, or 0.1 to 3 seconds. In some embodiments , the inhalation time can exceed 5 seconds, and the peak inspiratory differential pressure can exceed about 2 kPa, or be 2 -6 kPa. In some embodiments, the peak inspiratory pressure can exceed about 6 kPa ; the time to peak inspiratory pressure can be less than about 1.1 seconds, and the average pressure from the peak inspiratory differential pressure to 75% of the total inhalation time is about 4 kPa. These values represent the values of the relevant algorithms / programs used to train and monitor the inhalation by the inhalation monitoring systems 10 , 12 and the device 18, as well as high resistance dry powder inhalers. These depend on the behavioral parameters required for optimal delivery of the drug in the inhaler, including resistance, and can be modified in alternative inhaler training machines . In another exemplary embodiment, the dry powder inhaler can include sensing and / or monitoring devices that can monitor and / or sense signals generated by or within the dry powder inhaler during the patient's inhalation operation.

[0071] The dry powder inhaler can include sensor devices that are either integrated into or attached to the device. Alternatively , in an exemplary embodiment, the accessory devices 18, 24 can be provided as an integral part of the dry powder inhaler on the mouthpiece or housing as desired. In an alternative embodiment, the inhaler accessory devices 18, 24 can be removably attached to the inhaler .

[0072] ​​A detachable / semi-detachable sensing and monitoring device provided in the form of an outer casing or a cap, wherein the detachable sensing and monitoring device may be provided as a detachable part that can be adapted to a dry powder inhaler, in particular for wireless communication, so that the subject using the device can access and move more easily. In this embodiment, the outer casing is manufactured as a separate detachable device that includes one or more microprocessors, a wireless transceiver, an A / D converter, and sensors (such as a pressure sensor or a microphone) that can detect signals and store, transmit, or display signals. When an acoustic sensor is used, sound waves generated from an in-use inhaler with or without dry powder are detected by the microphone, and the signals are analyzed to be correlated with, depending on the type of sensor used, powder release when there is powder, air flow rate, the end of powder release during an inhalation operation, the temperature within the inhaler passage, etc. For example, an increase in sound may be correlated with an increase in the flow rate through the device and / or an increase in the collision of powder particles in the air stream being delivered.

[0073] Due to their small size, sensors such as microphones can be placed anywhere within the inhaler. In an embodiment where the sensor is a pressure transducer, the sensor can be placed within an air conduit passing through one of the compartments of the inhaler. The sensor can be provided, for example, on or within an air conduit within the inhaler, or in a shape or form that can be adapted to the inhaler and can be adapted or attached to the inhaler, such as a cap or an outer casing.

[0074] ​​​​​​​​​​, as an accessory to an inhaler that may include a form such as a sleeve or a saddle, it can be provided as a separately removable part. Regarding the removable embodiment, the sensing and monitoring attachment device is simple and inexpensive to manufacture,

[0075] and can be made of plastic and functions well with high resistance dry powder inhalers. In some embodiments, the sensor can be any sensor, such as a thermocouple wire, a pressure transducer, an analog sensor, a microphone, an optical sensor, a color sensor (including electromagnetic radiation sensors such as a spectrometer, an infrared sensor, and a visible spectrum sensor), a gas sensor, or any sensor capable of detecting a signal generated within the inhaler. The sensors described herein can be adapted to communicate or transmit signals using transceiver equipment, or the signal can be transmitted or stored using a wired connection to an analog-to-digital converter before transmitting this signal to a microprocessor. Alternatively, the analog-to-digital converter can be provided within the inhaler, and the resulting digital data is transferred directly from the device. The signals provided by the sensors described herein can be in several forms, including the airflow passing through the air conduit and / or the sound generated within the inhaler due to the collision of powder particles mixed into the airflow path, and the pressure drop detected near the airflow path due to the inhalation operation.

[0076] The signals generated by the inhaler can be detected by the sensors and stored, transmitted, or displayed. Other types of signals that can be detected by the system are text, color, cipher, or code, which are preferably or a light beam, laser beam, and Doppler sensor incorporated into an electronic board can be detected by. Data can be generated from the signals and analyzed qualitatively and / or quantitatively. In this way, including the dose release time, dose, type of dose, dosing time, etc., measurements can be made. Further, these signals can be associated with, for example, the identification of the patient, type of drug and dose, inhaler or other things, and used in a model ring of data requirements for proper inhalation and can facilitate the training of inhaler users.

[0077] In an exemplary embodiment, a sensing and monitoring system for an inhaler includes an accessory device structurally configured to be adapted to the inhaler; at least one sensor, microprocessor, any analog-to-digital converter; and a data storage medium. The data storage medium includes a disk drive, DVD, CD-ROM, server, flash card or drive, memory card reader, etc., and includes a set of machine-readable instructions executable by a microprocessor or other processing device to execute an algorithm. The algorithm, when executed, includes steps of generating a logical subsystem generation number obtained from the detected signals; storing the logical subsystem generation number on a data track within the logical subsystem, where the logical subsystem generation number is compared with a cluster-generation number within the processing device; and starting steps of storing and / or displaying information from the algorithm as a result of an inhalation operation.

[0078] In an alternative embodiment, the dry powder inhaler monitors and / or signals generated by the dry powder inhaler or within the dry powder inhaler during an inhalation operation by the patient or may comprise a perceptible sensing and / or monitoring device. The dry powder inhaler may comprise a sensor device incorporated or attached thereto. Alternatively, the accessory may be provided as an integral part of the dry powder inhaler on the mouthpiece or housing, as desired. In an alternative embodiment, the inhaler accessory is a detachable / removable sensing / monitoring device that can be disengaged from the inhaler and is in the form of a wrapper or cap, where the removable sensing / monitoring device is provided as a removable part that can be adapted to the dry powder inhaler, particularly for wireless communication, so that the subject using the device can access and move more easily. In this embodiment, the wrapper / inhaler accessory is manufactured as a separate removable device that includes on-board electronics for processing information, including one or more microprocessors, a wireless transceiver, an A / D converter, and sensors capable of detecting signals such as color signals and storing, transmitting, or displaying the signals. Exemplary embodiments are shown in FIGS. 20 - 22. The inhalation detection / monitoring device includes a detachable inhaler accessory 220 that is adapted to the inhaler and has a proximal end 228 and a distal end 230 and includes an on-board electronic system. The system includes a body 224 that includes a circuit board that includes two members, a top-side member and a bottom-side member, configured to fit together, and an electronic system disposed between the top-side member and the bottom-side member and held together by a fixing mechanism such as a screw. The top-side member includes arm extensions 226, 226'.

[0079] In an alternative embodiment, the inhaler accessory is a detachable / removable sensing / monitoring device that can be disengaged from the inhaler and is in the form of a wrapper or cap, where the removable sensing / monitoring device is provided as a removable part that can be adapted to the dry powder inhaler, particularly for wireless communication, so that the subject using the device can access and move more easily. In this embodiment, the wrapper / inhaler accessory is manufactured as a separate removable device that includes on-board electronics for processing information, including one or more microprocessors, a wireless transceiver, an A / D converter, and sensors capable of detecting signals such as color signals and storing, transmitting, or displaying the signals. Exemplary embodiments are shown in FIGS. 20 - 22. The inhalation detection / monitoring device includes a detachable inhaler accessory 220 that is adapted to the inhaler and has a proximal end 228 and a distal end 230 and includes an on-board electronic system. The system includes a body 224 that includes a circuit board that includes two members, a top-side member and a bottom-side member, configured to fit together, and an electronic system disposed between the top-side member and the bottom-side member and held together by a fixing mechanism such as a screw. The top-side member includes arm extensions 226, 226'.

[0080] Exemplary embodiments are shown in FIGS. 20 - 22. The inhalation detection / monitoring device includes a detachable inhaler accessory 220 that is adapted to the inhaler and has a proximal end 228 and a distal end 230 and includes an on-board electronic system. The system includes a body 224 that includes a circuit board that includes two members, a top-side member and a bottom-side member, configured to fit together, and an electronic system disposed between the top-side member and the bottom-side member and held together by a fixing mechanism such as a screw. The top-side member includes arm extensions 226, 226'. , the arm extension is away from the mouthpiece and protrudes downward to fit snugly onto the distal end of the inhaler including the fixing mechanism 223. The circuit board includes a microprocessor containing a transceiver; a differential pressure gauge; an absolute pressure gauge; and an accelerometer for determining the spatial orientation of the accessories assembly during use. FIG. 21 shows the bottom surface of the main body 224, the bottom side member, which includes a pressure equalizing channel 234 configured between the absolute pressure sensor and the differential pressure sensor to equalize the pressures in the absolute pressure sensor and the differential pressure sensor in use, and thus facilitate air communication between the absolute pressure sensor and the differential pressure sensor. In one embodiment, the differential pressure sensor / differential pressure gauge is configured to be placed very close to the inhaler air flow path, so as to communicate with the air path of the inhaler, and the absolute pressure sensor / absolute pressure gauge can be configured anywhere in the device. In a preferred embodiment, the absolute pressure sensor is configured within the circuit board and communicates with the differential pressure sensor through the pressure equalizing channel 234. A significant discovery of this system was that the inhalation detection and monitoring device did not function when the communication between the absolute pressure sensor and the differential pressure sensor was blocked. The main body 224 is also configured with an opening 236 on its bottom surface to provide access to a reset button for re-powering the system in case the operation button 225 fails. The main body 224 is also connected to a power supply such as a lithium battery for operating (on / off) button 225 to power on or off the system 220; a USB port 232 for recharging the system 220 or downloading stored information; an LED for displaying optical signals such as red (failed) or green (passed) signals. including a microprocessor containing a transceiver; a differential pressure gauge; an absolute pressure gauge; and an accelerometer for determining the spatial orientation of the accessories assembly during use. FIG. 21 shows the bottom surface of the main body 224, the bottom side member, which includes a pressure equalizing channel 234 configured between the absolute pressure sensor and the differential pressure sensor to equalize the pressures in the absolute pressure sensor and the differential pressure sensor in use, and thus facilitate air communication between the absolute pressure sensor and the differential pressure sensor. In one embodiment, the differential pressure sensor / differential pressure gauge is configured to be placed very close to the inhaler air flow path, so as to communicate with the air path of the inhaler, and the absolute pressure sensor / absolute pressure gauge can be configured anywhere in the device. In a preferred embodiment, the absolute pressure sensor is configured within the circuit board and communicates with the differential pressure sensor through the pressure equalizing channel 234. A significant discovery of this system was that the inhalation detection and monitoring device did not function when the communication between the absolute pressure sensor and the differential pressure sensor was blocked. The main body 224 is also configured with an opening 236 on its bottom surface to provide access to a reset button for re-powering the system in case the operation button 225 fails. The main body 224 is also connected to a power supply such as a lithium battery for operating (on / off) button 225 to power on or off the system 220; a USB port 232 for recharging the system 220 or downloading stored information; an LED for displaying optical signals such as red (failed) or green (passed) signals. including a microprocessor containing a transceiver; a differential pressure gauge; an absolute pressure gauge; and an accelerometer for determining the spatial orientation of the accessories assembly during use. FIG. 21 shows the bottom surface of the main body 224, the bottom side member, which includes a pressure equalizing channel 234 configured between the absolute pressure sensor and the differential pressure sensor to equalize the pressures in the absolute pressure sensor and the differential pressure sensor in use, and thus facilitate air communication between the absolute pressure sensor and the differential pressure sensor. In one embodiment, the differential pressure sensor / differential pressure gauge is configured to be placed very close to the inhaler air flow path, so as to communicate with the air path of the inhaler, and the absolute pressure sensor / absolute pressure gauge can be configured anywhere in the device. In a preferred embodiment, the absolute pressure sensor is configured within the circuit board and communicates with the differential pressure sensor through the pressure equalizing channel 234. A significant discovery of this system was that the inhalation detection and monitoring device did not function when the communication between the absolute pressure sensor and the differential pressure sensor was blocked. The main body 224 is also configured with an opening 236 on its bottom surface to provide access to a reset button for re-powering the system in case the operation button 225 fails. The main body 224 is also connected to a power supply such as a lithium battery for operating (on / off) button 225 to power on or off the system 220; a USB port 232 for recharging the system 220 or downloading stored information; an LED for displaying optical signals such as red (failed) or green (passed) signals.

[0081] The main body 224 is also connected to a power supply such as a lithium battery for operating (on / off) button 225 to power on or off the system 220; a USB port 232 for recharging the system 220 or downloading stored information; an LED for displaying optical signals such as red (failed) or green (passed) signals. including a microprocessor containing a transceiver; a differential pressure gauge; an absolute pressure gauge; and an accelerometer for determining the spatial orientation of the accessories assembly during use. FIG. 21 shows the bottom surface of the main body 224, the bottom side member, which includes a pressure equalizing channel 234 configured between the absolute pressure sensor and the differential pressure sensor to equalize the pressures in the absolute pressure sensor and the differential pressure sensor in use, and thus facilitate air communication between the absolute pressure sensor and the differential pressure sensor. In one embodiment, the differential pressure sensor / differential pressure gauge is configured to be placed very close to the inhaler air flow path, so as to communicate with the air path of the inhaler, and the absolute pressure sensor / absolute pressure gauge can be configured anywhere in the device. Quality signal indicator 227 including D light; Displays the status of the power / charging connector A system status indicator 229 configured proximate to the activation button 225 for Including. In a specific embodiment, depending on the complexity of the system, at least two emitters And sensors with at least two receivers can be used.

[0082] In this and other embodiments, during use, the accessory device 220 including an accelerometer Can detect the spatial orientation of the inhaler when the accessory device 220 is attached to the inhaler. For example, FIG. 22 shows an inhalation detection -Monitoring system 240 including an inhaler 242 compatible with the wireless accessory device 220. In this embodiment, when the system is activated, the movement of the inhaler Can be displayed on the screen of a mobile phone, tablet, etc. using an application that can inform the user of the correct positioning of the inhaler. If the inhaler is used in the wrong position before an inhalation operation to deliver a single dose of drug The device 220 will be displayed on the display in the wrong orientation / failure (red) or correct / appropriate orientation (green / white). Alternatively, if the device is not coupled to a PDA, computer, mobile phone, etc., depending on the positioning of the user's device, a tactile feedback signal or a visual signal Is generated from the device 220 to indicate whether the device in use is in the appropriate or inappropriate orientation, whether the orientation Is good or not. In yet another embodiment, the inhalation detection / Monitoring enclosure includes on-board electronics including one or more microprocessors, wireless transceivers, A / D converters, and sensors capable of detecting signals and storing, transmitting, or displaying signals Including. ​​, is manufactured as a separate removable device. In this embodiment, the software application (app) can be used on a wireless device, such as a smartphone and / or tablet, rather than a desktop or laptop computer. This app can provide a graphical interface showing a 3D model of the inhaler. The 3D model of the inhaler can provide feedback regarding the spatial orientation of the inhaler. For example, if the user holds the inhaler at an incorrect angle during inhalation, the user can be alerted regarding improper use by changing the color of the 3D inhaler model on the screen. For example, the 3D model can appear in red. Improper use of the inhaler can result in loss of the powder content during dosing. Instead, the voice / tablet app of the phone can indicate improper positioning of the inhaler by visually or audibly alerting the user of the incorrect orientation of the inhaler. In another embodiment, the inhalation accessory includes a color sensor that detects a plurality of individual wavelengths and includes individual wavelength measurement channels. The color sensor can identify, for example, the color of the capsule, or the identity information of the cartridge based on the dose of powder during use, the amount of powder in the cartridge, and can provide a high-quality release of the powder in the inhaler. The sensor can alert the user of these parameters by means of tactile feedback such as LED light, audible / notification to the user, or vibration. In one embodiment, a spectral sensor is used, where the sensor can detect individual or continuous wavelengths that can be algorithmically operated to determine the specific color of the cartridge or capsule. This type of sensor can be used to determine the identity of the cartridge or capsule, and can also be used to monitor the powder content in the inhaler and provide feedback to the user. During inhalation, if the user holds the inhaler at an incorrect angle, the user can be alerted to improper use by changing the color of the 3D inhaler model on the screen. For example, the 3D model can appear in red. Improper use of the inhaler can result in loss of the powder content during dosing. Instead, the voice / tablet app of the phone can indicate improper positioning of the inhaler by visually or audibly alerting the user of the incorrect orientation of the inhaler. In another embodiment, the inhalation accessory includes a color sensor that detects a plurality of individual wavelengths and includes individual wavelength measurement channels. The color sensor can identify, for example, the color of the capsule, or the identity information of the cartridge based on the dose of powder during use, the amount of powder in the cartridge, and can provide a high-quality release of the powder in the inhaler. The sensor can alert the user of these parameters by means of tactile feedback such as LED light, audible / notification to the user, or vibration. In one embodiment, a spectral sensor is used, where the sensor can detect individual or continuous wavelengths that can be algorithmically operated to determine the specific color of the cartridge or capsule. This type of sensor can be used to determine the identity of the cartridge or capsule, and can also be used to monitor the powder content in the inhaler and provide feedback to the user. During inhalation, if the user holds the inhaler at an incorrect angle, the user can be alerted to improper use by changing the color of the 3D inhaler model on the screen. For example, the 3D model can appear in red. Improper use of the inhaler can result in loss of the powder content during dosing. Instead, the voice / tablet app of the phone can indicate improper positioning of the inhaler by visually or audibly alerting the user of the incorrect orientation of the inhaler.

[0083] In another embodiment, the inhalation accessory includes a color sensor that detects a plurality of individual wavelengths and includes individual wavelength measurement channels. The color sensor can identify, for example, the color of the capsule, or the identity information of the cartridge based on the dose of powder during use, the amount of powder in the cartridge, and can provide a high-quality release of the powder in the inhaler. The sensor can alert the user of these parameters by means of tactile feedback such as LED light, audible / notification to the user, or vibration. In one embodiment, a spectral sensor is used, where the sensor can detect individual or continuous wavelengths that can be algorithmically operated to determine the specific color of the cartridge or capsule. This type of sensor can be used to determine the identity of the cartridge or capsule, and can also be used to monitor the powder content in the inhaler and provide feedback to the user. In another embodiment, the inhalation accessory includes a color sensor that detects a plurality of individual wavelengths and includes individual wavelength measurement channels. The color sensor can identify, for example, the color of the capsule, or the identity information of the cartridge based on the dose of powder during use, the amount of powder in the cartridge, and can provide a high-quality release of the powder in the inhaler. The sensor can alert the user of these parameters by means of tactile feedback such as LED light, audible / notification to the user, or vibration. In one embodiment, a spectral sensor is used, where the sensor can detect individual or continuous wavelengths that can be algorithmically operated to determine the specific color of the cartridge or capsule. This type of sensor can be used to determine the identity of the cartridge or capsule, and can also be used to monitor the powder content in the inhaler and provide feedback to the user. The sensor can alert the user of these parameters by means of tactile feedback such as LED light, audible / notification to the user, or vibration. In one embodiment, a spectral sensor is used, where the sensor can detect individual or continuous wavelengths that can be algorithmically operated to determine the specific color of the cartridge or capsule. This type of sensor can be used to determine the identity of the cartridge or capsule, and can also be used to monitor the powder content in the inhaler and provide feedback to the user. In one embodiment, a spectral sensor is used, where the sensor can detect individual or continuous wavelengths that can be algorithmically operated to determine the specific color of the cartridge or capsule. This type of sensor can be used to determine the identity of the cartridge or capsule, and can also be used to monitor the powder content in the inhaler and provide feedback to the user. Uses a spectral sensor to determine which color cartridge is in use and The dosage information of the cartridge can be used to determine whether the contents of the ridge are equivalent to the dosage strength. , the user may be notified or sent to confirm the dose, or data The data may be stored in the instrument for comparison at a later time. To further improve the accuracy of the data, the data may be analyzed by artificial intelligence algorithms.

[0084] In certain embodiments, the inhaler accessory device is capable of transmitting visible light, infrared light (IR), and / or It contains a light sensor that can measure ambient light signals, including ultraviolet (UV) energy. The issue is intended to determine information regarding the use of cartridges and the flow of powder through the inhaler. In one embodiment, the device may be used to emit from an inhaler or portions of an inhaler. The ambient light being illuminated or emitted by a secondary light source, including flickering light generated by an accessory device In this embodiment, the inhaler or Signals originating from multiple parts of the inhaler are intensified to improve precise detection of the optical signal. The signal generated by the inhaler under ambient or enhanced conditions is a signal that is specific to the active agent or drug. If color-coded to represent single doses, the cartridge or capsule that contains the single dose In one embodiment, the inhaler accessory comprises: A means for producing light is included which comprises a light emitting diode (LED).

[0085] In one embodiment, the inhaler accessory device detects, via a pressure sensor, when the user begins an inhalation effort. This embodiment includes an automatic collection system that detects the start of an inhalation maneuver, as measured by In this case, the pressure sensor is configured to detect a pressure difference at a predetermined value and activate the entire system to operate automatically. In some embodiments, the automatic collection of signals can also automatically switch off the device after a certain period of time that can be preset in the device. In this embodiment, the object of data capture includes the entire inhalation operation and detection of the cartridge in use. In one embodiment, the inhalation effort provided by the object is dynamically measured when a minimum threshold value occurs. In some embodiments, the automatic collection of signals can also automatically switch off the device after a certain period of time that can be preset in the device. In this embodiment, the object of data capture includes the entire inhalation operation and detection of the cartridge in use. In one embodiment, the inhalation effort provided by the object is dynamically measured when a minimum threshold value occurs. In another embodiment, the inhaler accessory device includes a system for storing and transmitting data regarding the inhaler and cartridge in use, including the inhalation operation and cartridge dosing or utilization parameters and powder flow characteristics, so that the information can be analyzed for optimizing the treatment compliance of the object's usage pattern and / or dosing plan. In this embodiment, the inhaler accessory device monitors the consistency of the object's use and delivery of the therapeutic dose. In one embodiment, the data obtained by the device is stored in the device and can be transmitted to a digital application, where the optimal therapeutic utility of the patient can be analyzed.

[0086] In yet another embodiment, sensors such as Doppler ultrasonic sensors or "time of flight" sensors can be used to measure the amount of powder released. The Doppler sensor can detect ultrasonic diffraction signals from the powder flow from the inhaler in use. The ultrasonic diffraction signal can provide feedback from the amount of powder released from the inhaler during inhalation and / or the quality of the inhalation operation (the amount of powder to be inhaled by the user), which can be provided to the user. In another embodiment, the inhaler accessory device includes a system for storing and transmitting data regarding the inhaler and cartridge in use, including the inhalation operation and cartridge dosing or utilization parameters and powder flow characteristics, so that the information can be analyzed for optimizing the treatment compliance of the object's usage pattern and / or dosing plan. In this embodiment, the inhaler accessory device monitors the consistency of the object's use and delivery of the therapeutic dose. In one embodiment, the data obtained by the device is stored in the device and can be transmitted to a digital application, where the optimal therapeutic utility of the patient can be analyzed. In yet another embodiment, sensors such as Doppler ultrasonic sensors or "time of flight" sensors can be used to measure the amount of powder released. The Doppler sensor can detect ultrasonic diffraction signals from the powder flow from the inhaler in use. The ultrasonic diffraction signal can provide feedback from the amount of powder released from the inhaler during inhalation and / or the quality of the inhalation operation (the amount of powder to be inhaled by the user), which can be provided to the user.

[0087] In yet another embodiment, sensors such as Doppler ultrasonic sensors or "time of flight" sensors can be used to measure the amount of powder released. The Doppler sensor can detect ultrasonic diffraction signals from the powder flow from the inhaler in use. The ultrasonic diffraction signal can provide feedback from the amount of powder released from the inhaler during inhalation and / or the quality of the inhalation operation (the amount of powder to be inhaled by the user), which can be provided to the user. The ultrasonic diffraction signal can provide feedback from the amount of powder released from the inhaler during inhalation and / or the quality of the inhalation operation (the amount of powder to be inhaled by the user), which can be provided to the user. The ultrasonic diffraction signal can provide feedback from the amount of powder released from the inhaler during inhalation and / or the quality of the inhalation operation (the amount of powder to be inhaled by the user), which can be provided to the user. and provided by, for example, LED illumination, tactile feedback (e.g., vibration), or audible / notification feedback on the housing or the tablet. For example, an LED on the housing or the tablet may illuminate a continuous red LED to alert the user to inhale more firmly, or may blink a red LED to alert the user to inhale longer, or may use a continuous green LED to alert the user to inhale accurately. Another example is the use of tactile feedback on the housing or the tablet, where vibration may be used to alert the user to inhale more firmly, or several vibrations may be used to alert the user to inhale longer, or the absence of vibration may indicate accurate inhalation. In another example, the device may inform the user of the quality of inhalation, particularly to assist visually impaired persons during powder administration. When training a subject to properly use an inhaler to deliver an effective amount of powdered medicament by inhalation, FIGS. 23-24 show examples of inhalation operations performed by naive subjects prior to the sole use of the inhalation detection and monitoring device as shown in FIGS. 20-22. For training purposes, an empty cartridge or placebo powder may be used so that the powdered medicament dose is not wasted. A screen shot from a mobile phone is interactively linked by a Bluetooth transceiver to the inhalation detection and monitoring device 220, where a standard baseline curve (blank area) is displayed to measure the subject's inhalation effort as a time index in seconds (FIG. 23). When training a subject to properly use an inhaler to deliver an effective amount of powdered medicament by inhalation, FIGS. 23-24 show examples of inhalation operations performed by naive subjects prior to the sole use of the inhalation detection and monitoring device as shown in FIGS. 20-22. For training purposes, an empty cartridge or placebo powder may be used so that the powdered medicament dose is not wasted. A screen shot from a mobile phone is interactively linked by a Bluetooth transceiver to the inhalation detection and monitoring device 220, where a standard baseline curve (blank area) is displayed to measure the subject's inhalation effort as a time index in seconds (FIG. 23). When training a subject to properly use an inhaler to deliver an effective amount of powdered medicament by inhalation, FIGS. 23-24 show examples of inhalation operations performed by naive subjects prior to the sole use of the inhalation detection and monitoring device as shown in FIGS. 20-22. For training purposes, an empty cartridge or placebo powder may be used so that the powdered medicament dose is not wasted. A screen shot from a mobile phone is interactively linked by a Bluetooth transceiver to the inhalation detection and monitoring device 220, where a standard baseline curve (blank area) is displayed to measure the subject's inhalation effort as a time index in seconds (FIG. 23). When training a subject to properly use an inhaler to deliver an effective amount of powdered medicament by inhalation, FIGS. 23-24 show examples of inhalation operations performed by naive subjects prior to the sole use of the inhalation detection and monitoring device as shown in FIGS. 20-22. For training purposes, an empty cartridge or placebo powder may be used so that the powdered medicament dose is not wasted. A screen shot from a mobile phone is interactively linked by a Bluetooth transceiver to the inhalation detection and monitoring device 220, where a standard baseline curve (blank area) is displayed to measure the subject's inhalation effort as a time index in seconds (FIG. 23). When training a subject to properly use an inhaler to deliver an effective amount of powdered medicament by inhalation, FIGS. 23-24 show examples of inhalation operations performed by naive subjects prior to the sole use of the inhalation detection and monitoring device as shown in FIGS. 20-22. For training purposes, an empty cartridge or placebo powder may be used so that the powdered medicament dose is not wasted. A screen shot from a mobile phone is interactively linked by a Bluetooth transceiver to the inhalation detection and monitoring device 220, where a standard baseline curve (blank area) is displayed to measure the subject's inhalation effort as a time index in seconds (FIG. 23). When training a subject to properly use an inhaler to deliver an effective amount of powdered medicament by inhalation, FIGS. 23-24 show examples of inhalation operations performed by naive subjects prior to the sole use of the inhalation detection and monitoring device as shown in FIGS. 20-22. For training purposes, an empty cartridge or placebo powder may be used so that the powdered medicament dose is not wasted. A screen shot from a mobile phone is interactively linked by a Bluetooth transceiver to the inhalation detection and monitoring device 220, where a standard baseline curve (blank area) is displayed to measure the subject's inhalation effort as a time index in seconds (FIG. 23). When training a subject to properly use an inhaler to deliver an effective amount of powdered medicament by inhalation, FIGS. 23-24 show examples of inhalation operations performed by naive subjects prior to the sole use of the inhalation detection and monitoring device as shown in FIGS. 20-22. For training purposes, an empty cartridge or placebo powder may be used so that the powdered medicament dose is not wasted. A screen shot from a mobile phone is interactively linked by a Bluetooth transceiver to the inhalation detection and monitoring device 220, where a standard baseline curve (blank area) is displayed to measure the subject's inhalation effort as a time index in seconds (FIG. 23). When training a subject to properly use an inhaler to deliver an effective amount of powdered medicament by inhalation, FIGS. 23-24 show examples of inhalation operations performed by naive subjects prior to the sole use of the inhalation detection and monitoring device as shown in FIGS. 20-22. For training purposes, an empty cartridge or placebo powder may be used so that the powdered medicament dose is not wasted. A screen shot from a mobile phone is interactively linked by a Bluetooth transceiver to the inhalation detection and monitoring device 220, where a standard baseline curve (blank area) is displayed to measure the subject's inhalation effort as a time index in seconds (FIG. 23). When training a subject to properly use an inhaler to deliver an effective amount of powdered medicament by inhalation, FIGS. 23-24 show examples of inhalation operations performed by naive subjects prior to the sole use of the inhalation detection and monitoring device as shown in FIGS. 20-22. For training purposes, an empty cartridge or placebo powder may be used so that the powdered medicament dose is not wasted. A screen shot from a mobile phone is interactively linked by a Bluetooth transceiver to the inhalation detection and monitoring device 220, where a standard baseline curve (blank area) is displayed to measure the subject's inhalation effort as a time index in seconds (FIG. 23).

[0088] When training a subject to properly use an inhaler to deliver an effective amount of powdered medicament by inhalation, FIGS. 23-24 show examples of inhalation operations performed by naive subjects prior to the sole use of the inhalation detection and monitoring device as shown in FIGS. 20-22. For training purposes, an empty cartridge or placebo powder may be used so that the powdered medicament dose is not wasted. A screen shot from a mobile phone is interactively linked by a Bluetooth transceiver to the inhalation detection and monitoring device 220, where a standard baseline curve (blank area) is displayed to measure the subject's inhalation effort as a time index in seconds (FIG. 23). When training a subject to properly use an inhaler to deliver an effective amount of powdered medicament by inhalation, FIGS. 23-24 show examples of inhalation operations performed by naive subjects prior to the sole use of the inhalation detection and monitoring device as shown in FIGS. 20-22. For training purposes, an empty cartridge or placebo powder may be used so that the powdered medicament dose is not wasted. A screen shot from a mobile phone is interactively linked by a Bluetooth transceiver to the inhalation detection and monitoring device 220, where a standard baseline curve (blank area) is displayed to measure the subject's inhalation effort as a time index in seconds (FIG. 23). When training a subject to properly use an inhaler to deliver an effective amount of powdered medicament by inhalation, FIGS. 23-24 show examples of inhalation operations performed by naive subjects prior to the sole use of the inhalation detection and monitoring device as shown in FIGS. 20-22. For training purposes, an empty cartridge or placebo powder may be used so that the powdered medicament dose is not wasted. A screen shot from a mobile phone is interactively linked by a Bluetooth transceiver to the inhalation detection and monitoring device 220, where a standard baseline curve (blank area) is displayed to measure the subject's inhalation effort as a time index in seconds (FIG. 23). When training a subject to properly use an inhaler to deliver an effective amount of powdered medicament by inhalation, FIGS. 23-24 show examples of inhalation operations performed by naive subjects prior to the sole use of the inhalation detection and monitoring device as shown in FIGS. 20-22. For training purposes, an empty cartridge or placebo powder may be used so that the powdered medicament dose is not wasted. A screen shot from a mobile phone is interactively linked by a Bluetooth transceiver to the inhalation detection and monitoring device 220, where a standard baseline curve (blank area) is displayed to measure the subject's inhalation effort as a time index in seconds (FIG. 23). When training a subject to properly use an inhaler to deliver an effective amount of powdered medicament by inhalation, FIGS. 23-24 show examples of inhalation operations performed by naive subjects prior to the sole use of the inhalation detection and monitoring device as shown in FIGS. 20-22. For training purposes, an empty cartridge or placebo powder may be used so that the powdered medicament dose is not wasted. A screen shot from a mobile phone is interactively linked by a Bluetooth transceiver to the inhalation detection and monitoring device 220, where a standard baseline curve (blank area) is displayed to measure the subject's inhalation effort as a time index in seconds (FIG. 23). When training a subject to properly use an inhaler to deliver an effective amount of powdered medicament by inhalation, FIGS. 23-24 show examples of inhalation operations performed by naive subjects prior to the sole use of the inhalation detection and monitoring device as shown in FIGS. 20-22. For training purposes, an empty cartridge or placebo powder may be used so that the powdered medicament dose is not wasted. A screen shot from a mobile phone is interactively linked by a Bluetooth transceiver to the inhalation detection and monitoring device 220, where a standard baseline curve (blank area) is displayed to measure the subject's inhalation effort as a time index in seconds (FIG. 23). When training a subject to properly use an inhaler to deliver an effective amount of powdered medicament by inhalation, FIGS. 23-24 show examples of inhalation operations performed by naive subjects prior to the sole use of the inhalation detection and monitoring device as shown in FIGS. 20-22. For training purposes, an empty cartridge or placebo powder may be used so that the powdered medicament dose is not wasted. A screen shot from a mobile phone is interactively linked by a Bluetooth transceiver to the inhalation detection and monitoring device 220, where a standard baseline curve (blank area) is displayed to measure the subject's inhalation effort as a time index in seconds (FIG. 23).

[0089] FIG. 23 shows a mobile phone display when the device 220 is activated and the mobile phone is also turned on. Screenshots of the play, and screenshots of the mobile phone before inhalation, song A graphical user interface where the area above curve A is pass and the area below curve A is fail. The area above curve A represents data obtained from multiple measurements from the inhaler. From the data, a standard baseline was determined, which is graphically represented as a single inhalation. The inhaler threshold parameters for effectively delivering that powder content during inhalation are shown. When the threshold parameter is reached, the area below A is shaded in FIG. (Color may also be used) and the user's inhalation that produced curve B above the standard curve was correct Therefore, a user's inhalation effectively delivers a dose of the powder contained in the inhaler. indicates that it is acceptable to

[0090] If the patient is inhaling improperly, Figures 25 and 26 show two different scenarios. Figure 25 is a screenshot of the resulting user inhalation, demonstrating the user's effort. The forces fell within the standard curve, indicating successful inhalation to deliver a single dose of powder. The displayed standard curve will be visually dark / red and will indicate failure. In this scenario, the user inhales for the prescribed period of time, but with a weaker effort. When training this object, the user arrives at a graphic similar to that shown in Figure 24. The user is instructed to inhale more firmly or with more effort until 6 is a mobile phone screen showing an unsuccessful inhalation effort that was not sustained for an adequate period by the user. A clean shot. In this scenario, the user's inhalation was initially correct, but The user was unable to maintain the inhalation effort for the time required for proper inhaler use. Therefore, in this case, the user will not be able to receive the total amount of the drug. Subsequently , the user is instructed to maintain the initial strong inhalation effort for a longer period until the user exceeds the threshold parameter of the inhaler and can generate a curve similar to that shown in FIG. 24. In this way , the user of the inhaler can be properly trained to use the user's inhaler without assistance and take it by themselves.

[0091] FIGS. 27 and 28 are flowcharts showing the operating steps of an embodiment of an inhalation detection and monitoring device in use. In FIG. 27, an inhaler for use with a dry powder inhaler, for example, the AFREZZA® inhaler (MannKind Corp.), is adapted to a removable detection and monitoring device. As shown in FIG. 27, at the start of training, the inhalation detection and monitoring device is assembled to the inhaler as shown in FIG. 22. All devices are powered at step 250. Depending on the patient's food intake or the patient's blood glucose level at step 253, at step 252, an appropriate dose of the cartridge is selected from 4 units, 8 units, 12 units or 16 units, and at step 254, it is installed in the inhaler by opening the inhaler and inserting the cartridge into the cartridge mounting area of the inhaler. Once an appropriate dose of the cartridge is inserted into the inhaler, the inhaler is closed at step 256. A sensor, which may include an optical sensor or a color sensor, is triggered to detect the identification information of the cartridge in the cartridge mounting area of the inhaler, and the data is stored and transmitted to the microprocessor. Once the cartridge is detected in the inhaler and the appropriate dose of the cartridge is inserted into the inhaler, the inhaler is closed at step 256. A sensor, which may include an optical sensor or a color sensor, is triggered to detect the identification information of the cartridge in the cartridge mounting area of the inhaler, and the data is stored and transmitted to the microprocessor. Once the cartridge is detected in the inhaler and data is stored and transmitted to the microprocessor. Once the cartridge is detected in the inhaler If so, before inhalation, the orientation evaluation 258 and the position of the inhaler are analyzed. The signal received by the smartphone / tablet is used to display a three-dimensional model of the inhaler in an acceptable color selected for appropriate spatial orientation on the wireless device screen, and this display uses an application that displays a graphical interface at 260. At 262, if the inhaler is in the correct / appropriate special orientation for inhalation, the color selected for the three-dimensional display of the inhaler should remain the same 269. At 261, if the inhaler is in an incorrect / inappropriate position for inhalation due to improper rotation and pitch of the inhaler, the three-dimensional image of the inhaler changes to a non-conformance indicator different from that selected for the inhaler in the correct position, for example to red 264. When the position of the inhaler is corrected at step 266, the three-dimensional model of the inhaler changes to the selected color. When inhalation begins, the pressure sensor is triggered and the quality of inhalation is evaluated by the processing system 270. At 272, the processing system within the device calculates and displays a signal corresponding to the quality of the inhalation operation. A visible signal is displayed from the quality LED signal display of the inhalation detection / monitoring device (housing), and this display shows a continuous red LED for an inaccurate / inappropriate inhalation effort performed at 273 (this is to inform the user at step 276 that the inhalation was weak and subsequent inhalations need to be done more firmly or strongly), or a flashing red LED for an inaccurate / inappropriate inhalation effort due to the duration of the inhalation performed being too short (this indicates to the user at 27 8 that subsequent inhalation efforts need to be longer to achieve proper inhalation), and for the single-dose dry powder at step 279 ​​​​​​​​ A continuous green LED light display that meets all the standards necessary for delivery to the target is.

[0092] In a further embodiment for use in combination with diabetes treatment, the blood glucose meter may be incorporated into a removable inhalation detection / monitoring device / enclosure, where the enclosure measures blood glucose using smart blood glucose measurement strips and blood samples to determine the target's blood glucose level and minimize the number of devices that need to be used by the target in the treatment plan. The smart blood glucose measurement strips communicate with a wireless transceiver within the inhalation detection / monitoring device to determine the blood glucose level of the patient that can be calculated from the information obtained from the blood sample prior to determining the appropriate dose required by the patient to lower the patient's blood glucose level. standing, the blood glucose level can be determined.

[0093] In an alternative embodiment of use, shown in Figure 28, the steps of training the target to use the inhaler, steps 280-298, are the same or similar to steps 250-274 but the device is constructed and programmed using different communication codes and visual display signals. In this embodiment, the inhalation detection / monitoring device includes alternative device-visible signals unique to the device that can only be displayed on the device or linked to a mobile phone or tablet. When performing steps 280-296 of inhalation, in step 297, the inhalation parameters are evaluated with respect to the quality of the inhalation, followed by a signal corresponding to the quality of the inhalation being calculated and displayed at 298 by the processing program. In step 299, the graphical interface of the smartphone / tablet displays a graph of acceptable inhalations. A continuous red graphical indicator indicates inaccurate / inappropriate inhalation operations / efforts, and a continuous red graphical indicator indicates inaccurate / inappropriate inhalation operations / efforts, and For subsequent inhalations, the user is instructed to inhale more firmly until a seamless green graphical indicator display indicating appropriate inhalation effort for dry powder dosing is achieved. 301. In step 300, if the graphical interface indicator displays red and green graphs, the inhalation effort is incorrect / inappropriate and a seamless green graph display needs to be achieved, and the user is instructed to inhale for a longer period. Once the user has achieved a seamless green graphical interface after several attempts, the user is properly trained using the inhaler, the power of the removable detection / sensing device is turned off, and the user can be sent home, being appropriately trained to start the dosing plan. For subsequent inhalations, the user is instructed to inhale more firmly until a seamless green graphical indicator display indicating appropriate inhalation effort for dry powder dosing is achieved. 301. In step 300, if the graphical interface indicator displays red and green graphs, the inhalation effort is incorrect / inappropriate and a seamless green graph display needs to be achieved, and the user is instructed to inhale for a longer period. Once the user has achieved a seamless green graphical interface after several attempts, the user is properly trained using the inhaler, the power of the removable detection / sensing device is turned off, and the user can be sent home, being appropriately trained to start the dosing plan. For subsequent inhalations, the user is instructed to inhale more firmly until a seamless green graphical indicator display indicating appropriate inhalation effort for dry powder dosing is achieved. 301. In step 300, if the graphical interface indicator displays red and green graphs, the inhalation effort is incorrect / inappropriate and a seamless green graph display needs to be achieved, and the user is instructed to inhale for a longer period. Once the user has achieved a seamless green graphical interface after several attempts, the user is properly trained using the inhaler, the power of the removable detection / sensing device is turned off, and the user can be sent home, being appropriately trained to start the dosing plan. For subsequent inhalations, the user is instructed to inhale more firmly until a seamless green graphical indicator display indicating appropriate inhalation effort for dry powder dosing is achieved. 301. In step 300, if the graphical interface indicator displays red and green graphs, the inhalation effort is incorrect / inappropriate and a seamless green graph display needs to be achieved, and the user is instructed to inhale for a longer period. Once the user has achieved a seamless green graphical interface after several attempts, the user is properly trained using the inhaler, the power of the removable detection / sensing device is turned off, and the user can be sent home, being appropriately trained to start the dosing plan. For subsequent inhalations, the user is instructed to inhale more firmly until a seamless green graphical indicator display indicating appropriate inhalation effort for dry powder dosing is achieved. 301. In step 300, if the graphical interface indicator displays red and green graphs, the inhalation effort is incorrect / inappropriate and a seamless green graph display needs to be achieved, and the user is instructed to inhale for a longer period. Once the user has achieved a seamless green graphical interface after several attempts, the user is properly trained using the inhaler, the power of the removable detection / sensing device is turned off, and the user can be sent home, being appropriately trained to start the dosing plan. For subsequent inhalations, the user is instructed to inhale more firmly until a seamless green graphical indicator display indicating appropriate inhalation effort for dry powder dosing is achieved. 301. In step 300, if the graphical interface indicator displays red and green graphs, the inhalation effort is incorrect / inappropriate and a seamless green graph display needs to be achieved, and the user is instructed to inhale for a longer period. Once the user has achieved a seamless green graphical interface after several attempts, the user is properly trained using the inhaler, the power of the removable detection / sensing device is turned off, and the user can be sent home, being appropriately trained to start the dosing plan. For subsequent inhalations, the user is instructed to inhale more firmly until a seamless green graphical indicator display indicating appropriate inhalation effort for dry powder dosing is achieved. 301. In step 300, if the graphical interface indicator displays red and green graphs, the inhalation effort is incorrect / inappropriate and a seamless green graph display needs to be achieved, and the user is instructed to inhale for a longer period. Once the user has achieved a seamless green graphical interface after several attempts, the user is properly trained using the inhaler, the power of the removable detection / sensing device is turned off, and the user can be sent home, being appropriately trained to start the dosing plan. For subsequent inhalations, the user is instructed to inhale more firmly until a seamless green graphical indicator display indicating appropriate inhalation effort for dry powder dosing is achieved. 301. In step 300, if the graphical interface indicator displays red and green graphs, the inhalation effort is incorrect / inappropriate and a seamless green graph display needs to be achieved, and the user is instructed to inhale for a longer period. Once the user has achieved a seamless green graphical interface after several attempts, the user is properly trained using the inhaler, the power of the removable detection / sensing device is turned off, and the user can be sent home, being appropriately trained to start the dosing plan. For subsequent inhalations, the user is instructed to inhale more firmly until a seamless green graphical indicator display indicating appropriate inhalation effort for dry powder dosing is achieved. 301. In step 300, if the graphical interface indicator displays red and green graphs, the inhalation effort is incorrect / inappropriate and a seamless green graph display needs to be achieved, and the user is instructed to inhale for a longer period. Once the user has achieved a seamless green graphical interface after several attempts, the user is properly trained using the inhaler, the power of the removable detection / sensing device is turned off, and the user can be sent home, being appropriately trained to start the dosing plan.

[0094] In certain embodiments, the inhaler accessory device is particularly useful for a dry powder inhaler comprising a unit dose cartridge and a drug delivery formulation comprising, for example, diketopiperazine, particularly fumaryl diketopiperazine, and an active ingredient such as a peptide and a protein such as an endocrine hormone including epithalamic hormone, insulin, oxytocin, tomomodulin and glucagon-like peptide 1; symlin i.e. pramlintide acetate, nicotine, a neurotransmitter such as a cannabinoid, 5-hydroxytryptamine, a dopaminergic, prostacyclin, an opioid agonist and antagonist. In certain embodiments, the inhaler accessory device is particularly useful for a dry powder inhaler comprising a unit dose cartridge and a drug delivery formulation comprising, for example, diketopiperazine, particularly fumaryl diketopiperazine, and an active ingredient such as a peptide and a protein such as an endocrine hormone including epithalamic hormone, insulin, oxytocin, tomomodulin and glucagon-like peptide 1; symlin i.e. pramlintide acetate, nicotine, a neurotransmitter such as a cannabinoid, 5-hydroxytryptamine, a dopaminergic, prostacyclin, an opioid agonist and antagonist. In certain embodiments, the inhaler accessory device is particularly useful for a dry powder inhaler comprising a unit dose cartridge and a drug delivery formulation comprising, for example, diketopiperazine, particularly fumaryl diketopiperazine, and an active ingredient such as a peptide and a protein such as an endocrine hormone including epithalamic hormone, insulin, oxytocin, tomomodulin and glucagon-like peptide 1; symlin i.e. pramlintide acetate, nicotine, a neurotransmitter such as a cannabinoid, 5-hydroxytryptamine, a dopaminergic, prostacyclin, an opioid agonist and antagonist. In certain embodiments, the inhaler accessory device is particularly useful for a dry powder inhaler comprising a unit dose cartridge and a drug delivery formulation comprising, for example, diketopiperazine, particularly fumaryl diketopiperazine, and an active ingredient such as a peptide and a protein such as an endocrine hormone including epithalamic hormone, insulin, oxytocin, tomomodulin and glucagon-like peptide 1; symlin i.e. pramlintide acetate, nicotine, a neurotransmitter such as a cannabinoid, 5-hydroxytryptamine, a dopaminergic, prostacyclin, an opioid agonist and antagonist. In certain embodiments, the inhaler accessory device is particularly useful for a dry powder inhaler comprising a unit dose cartridge and a drug delivery formulation comprising, for example, diketopiperazine, particularly fumaryl diketopiperazine, and an active ingredient such as a peptide and a protein such as an endocrine hormone including epithalamic hormone, insulin, oxytocin, tomomodulin and glucagon-like peptide 1; symlin i.e. pramlintide acetate, nicotine, a neurotransmitter such as a cannabinoid, 5-hydroxytryptamine, a dopaminergic, prostacyclin, an opioid agonist and antagonist. In certain embodiments, the inhaler accessory device is particularly useful for a dry powder inhaler comprising a unit dose cartridge and a drug delivery formulation comprising, for example, diketopiperazine, particularly fumaryl diketopiperazine, and an active ingredient such as a peptide and a protein such as an endocrine hormone including epithalamic hormone, insulin, oxytocin, tomomodulin and glucagon-like peptide 1; symlin i.e. pramlintide acetate, nicotine, a neurotransmitter such as a cannabinoid, 5-hydroxytryptamine, a dopaminergic, prostacyclin, an opioid agonist and antagonist. In certain embodiments, the inhaler accessory device is particularly useful for a dry powder inhaler comprising a unit dose cartridge and a drug delivery formulation comprising, for example, diketopiperazine, particularly fumaryl diketopiperazine, and an active ingredient such as a peptide and a protein such as an endocrine hormone including epithalamic hormone, insulin, oxytocin, tomomodulin and glucagon-like peptide 1; symlin i.e. pramlintide acetate, nicotine, a neurotransmitter such as a cannabinoid, 5-hydroxytryptamine, a dopaminergic, prostacyclin, an opioid agonist and antagonist. In some embodiments, the active ingredient in the formulation includes, but is not limited to, salmeterol, epinephrine, tacrolimus, vancomycin, linezolid, filgastrim, In some embodiments, the active ingredient in the formulation includes, but is not limited to, salmeterol, epinephrine, tacrolimus, vancomycin, linezolid, filgastrim, Fentanyl, cannabinoids such as cannabidiol and tetrahydrocannabinol (THC), or derivatives thereof; paroxetine, amphotericin B, phosphodies terase inhibitors such as PDE5 inhibitors such as sildenafil, avanafil, bel denafil, and tadalafil; prostaglandins, prosta cyclins such as treprostinil, neurotransmitter agonists, neurotransmitter antagonists, e.g. anti-nociceptive agents, opioid analgesics, e.g. δ opioid agonists and antagonists, κ opioid receptor agonists and antagonists, μ opioid receptor agonists and antagonists, nicotine, norepinephrine dopamine reuptake inhibitors (NDRI) and nicotinic receptor antagonists, nicotinic acetylcholine receptor agonists, va lenicline, cytisine, bupropion, derivatives thereof, pharmaceutically acceptable salts thereof, or combinations thereof, comprising one or more active agents.

[0095] An inhaler accessory device is provided, the inhaler accessory device comprising: a body configured to be attached to or connected to an inhaler; a microprocessor; at least two pressure sensors, a first pressure sensor for detecting information on environmental conditions around the inhaler; and a second pressure sensor for detecting a signal generated from the inhaler during use, and a pressure equalization channel between the first pressure sensor and the second pressure sensor, wherein the first pressure sensor and the second pressure sensor each generate at least one signal, and the signal is processed in the microprocessor and customized micropro cessor is processed in the microprocessor and customized micropro becomes the sensor output, and the microprocessor output generates a pressure difference vs. time curve on the display simultaneously with or immediately after the user's inhalation. The accessory device for the inhaler is characterized in that the first pressure sensor and the second pressure sensor are digital sensors, and their outputs are in digital format.

[0096] The accessory device for the inhaler further includes that the second pressure sensor is an analog sensor, and its output is in analog format, and the device further includes additional circuitry for adjusting, filtering , amplifying and / or converting the sensor signal to digital format. obtained.

[0097] The second pressure sensor detects the pressure drop measured in the flow path of the inhaler, and furthermore, the second pressure sensor detects the atmospheric pressure, the accessory device for the inhaler as described above .

[0098] Furthermore, an accessory device for the inhaler as described above includes an optical sensor that detects visible light or enhanced optical signals emitted from the inhaler during use under ambient conditions. In this embodiment, the accessory device for the inhaler further includes a light-emitting diode.

[0099] Furthermore, a laser beam, Doppler sensor, infrared sensor or other sensing beam configured to detect characteristic profiles of multiple parts of the inhaler, the inhaler cartridge, or other drug packages. In one embodiment, the inhaler for use with the accessory device includes a dry powder inhaler. In some embodiments the accessory device for the inhaler as described above includes a cartridge and a dry powder formulation. ​​​​An ipowder inhaler, and the dry powder formulation contains diketopiperazine and at least one active ingredient.

[0100] The differential pressure sensor detects the pressure drop measured in the inhaler, and the absolute pressure se nsor, if necessary, is used in combination with the differential pressure sensor to adjust for atmospheric conditions before identifying the pressure drop, such as the accessory device for an inhaler as described above.

[0101] Furthermore: a color detection sensor that senses the color of the inhaler cartridge or other drug package loaded into the inhaler, an RFID reader for reading the RFID tag in the cartridge or other drug package loaded into the inhaler, and an image detection sensor that can identify the characters, codes or text information provided on the inhaler or the inhaler cartridge or other drug package, such as the accessory device for an inhaler as described above, including one or more of them. Furthermore, a wireless transceiver through which data received from at least two sensors is transmitted to a remote processing system, and an electronic board are included, and the microprocessor, the sensor and the wireless transceiver are connected to and / or arranged on the electronic board, such as the accessory device for an inhaler as described above. In one embodiment, the accessory device for an inhaler further includes a visible indicator

[0102] Furthermore, a display for displaying the difference between the ideal or predetermined inhalation parameters and the achieved / user-performed inhalation operation, or a display for indicating to the user whether it is qualified / unqualified, i.e., a green / red indicator. In some embodiments, the accessory device for an inhaler is characterized by having a visible indicator for the user, i.e., a green / red indicator as qualified / unqualified. In some embodiments, the inhalation operation or the achieved / user-performed inhalation operation, or a display for indicating to the user whether it is qualified / unqualified, i.e., a green / red indicator. In some embodiments, the accessory device for an inhaler is characterized by having a visible indicator for the user, i.e., a green / red indicator as qualified / unqualified. In some embodiments, the inhalation operation If successfully achieved, other communication modes to the user can be used, for example, in a graphical or other display format within a remote smart device. A dry powder inhaler monitoring and detection system is also provided, the system comprising: a dry powder inhaler; a microprocessor, a wireless transceiver, and a first sensor for detecting pressure differential information in the region or part of the inhaler; and a second pressure sensor for detecting a signal generated from the inhaler during use and communicating with the first sensor through a pressure equalizing channel; the first and second pressure sensors each generate at least one signal, which is processed by the microprocessor to become a customized microprocessor output, and the microprocessor output is compared with a graph of pre-determined profile values for the inhaler type to generate a graphical display of the pressure-time curve characteristics of the inhalation operation performed by the user. The dry powder inhaler monitoring and detection system may further include a remote processing system including a display, a wireless transceiver, and a microprocessor configured to report a graphical pass or fail indication on the display, including a threshold corresponding to the detected first sensor information and user inhalation data corresponding to the second sensor signal.

[0103] A dry powder inhaler monitoring and detection system is also provided, the system comprising: a dry powder inhaler; a microprocessor, a wireless transceiver, and a first sensor for detecting pressure differential information in the region or part of the inhaler; and a second pressure sensor for detecting a signal generated from the inhaler during use and communicating with the first sensor through a pressure equalizing channel; the first and second pressure sensors each generate at least one signal, which is processed by the microprocessor to become a customized microprocessor output, and the microprocessor output is compared with a graph of pre-determined profile values for the inhaler type to generate a graphical display of the pressure-time curve characteristics of the inhalation operation performed by the user. The dry powder inhaler monitoring and detection system may further include a remote processing system including a display, a wireless transceiver, and a microprocessor configured to report a graphical pass or fail indication on the display, including a threshold corresponding to the detected first sensor information and user inhalation data corresponding to the second sensor signal. A dry powder inhaler; a microprocessor, a wireless transceiver, and a first sensor for detecting pressure differential information in the region or part of the inhaler; and a second pressure sensor for detecting a signal generated from the inhaler during use and communicating with the first sensor through a pressure equalizing channel; the first and second pressure sensors each generate at least one signal, which is processed by the microprocessor to become a customized microprocessor output, and the microprocessor output is compared with a graph of pre-determined profile values for the inhaler type to generate a graphical display of the pressure-time curve characteristics of the inhalation operation performed by the user. The dry powder inhaler monitoring and detection system may further include a remote processing system including a display, a wireless transceiver, and a microprocessor configured to report a graphical pass or fail indication on the display, including a threshold corresponding to the detected first sensor information and user inhalation data corresponding to the second sensor signal. A dry powder inhaler; a microprocessor, a wireless transceiver, and a first sensor for detecting pressure differential information in the region or part of the inhaler; and a second pressure sensor for detecting a signal generated from the inhaler during use and communicating with the first sensor through a pressure equalizing channel; the first and second pressure sensors each generate at least one signal, which is processed by the microprocessor to become a customized microprocessor output, and the microprocessor output is compared with a graph of pre-determined profile values for the inhaler type to generate a graphical display of the pressure-time curve characteristics of the inhalation operation performed by the user. The dry powder inhaler monitoring and detection system may further include a remote processing system including a display, a wireless transceiver, and a microprocessor configured to report a graphical pass or fail indication on the display, including a threshold corresponding to the detected first sensor information and user inhalation data corresponding to the second sensor signal. A dry powder inhaler; a microprocessor, a wireless transceiver, and a first sensor for detecting pressure differential information in the region or part of the inhaler; and a second pressure sensor for detecting a signal generated from the inhaler during use and communicating with the first sensor through a pressure equalizing channel; the first and second pressure sensors each generate at least one signal, which is processed by the microprocessor to become a customized microprocessor output, and the microprocessor output is compared with a graph of pre-determined profile values for the inhaler type to generate a graphical display of the pressure-time curve characteristics of the inhalation operation performed by the user. The dry powder inhaler monitoring and detection system may further include a remote processing system including a display, a wireless transceiver, and a microprocessor configured to report a graphical pass or fail indication on the display, including a threshold corresponding to the detected first sensor information and user inhalation data corresponding to the second sensor signal. A dry powder inhaler; a microprocessor, a wireless transceiver, and a first sensor for detecting pressure differential information in the region or part of the inhaler; and a second pressure sensor for detecting a signal generated from the inhaler during use and communicating with the first sensor through a pressure equalizing channel; the first and second pressure sensors each generate at least one signal, which is processed by the microprocessor to become a customized microprocessor output, and the microprocessor output is compared with a graph of pre-determined profile values for the inhaler type to generate a graphical display of the pressure-time curve characteristics of the inhalation operation performed by the user. The dry powder inhaler monitoring and detection system may further include a remote processing system including a display, a wireless transceiver, and a microprocessor configured to report a graphical pass or fail indication on the display, including a threshold corresponding to the detected first sensor information and user inhalation data corresponding to the second sensor signal. A dry powder inhaler; a microprocessor, a wireless transceiver, and a first sensor for detecting pressure differential information in the region or part of the inhaler; and a second pressure sensor for detecting a signal generated from the inhaler during use and communicating with the first sensor through a pressure equalizing channel; the first and second pressure sensors each generate at least one signal, which is processed by the microprocessor to become a customized microprocessor output, and the microprocessor output is compared with a graph of pre-determined profile values for the inhaler type to generate a graphical display of the pressure-time curve characteristics of the inhalation operation performed by the user. The dry powder inhaler monitoring and detection system may further include a remote processing system including a display, a wireless transceiver, and a microprocessor configured to report a graphical pass or fail indication on the display, including a threshold corresponding to the detected first sensor information and user inhalation data corresponding to the second sensor signal. A dry powder inhaler; a microprocessor, a wireless transceiver, and a first sensor for detecting pressure differential information in the region or part of the inhaler; and a second pressure sensor for detecting a signal generated from the inhaler during use and communicating with the first sensor through a pressure equalizing channel; the first and second pressure sensors each generate at least one signal, which is processed by the microprocessor to become a customized microprocessor output, and the microprocessor output is compared with a graph of pre-determined profile values for the inhaler type to generate a graphical display of the pressure-time curve characteristics of the inhalation operation performed by the user. The dry powder inhaler monitoring and detection system may further include a remote processing system including a display, a wireless transceiver, and a microprocessor configured to report a graphical pass or fail indication on the display, including a threshold corresponding to the detected first sensor information and user inhalation data corresponding to the second sensor signal. A dry powder inhaler; a microprocessor, a wireless transceiver, and a first sensor for detecting pressure differential information in the region or part of the inhaler; and a second pressure sensor for detecting a signal generated from the inhaler during use and communicating with the first sensor through a pressure equalizing channel; the first and second pressure sensors each generate at least one signal, which is processed by the microprocessor to become a customized microprocessor output, and the microprocessor output is compared with a graph of pre-determined profile values for the inhaler type to generate a graphical display of the pressure-time curve characteristics of the inhalation operation performed by the user. The dry powder inhaler monitoring and detection system may further include a remote processing system including a display, a wireless transceiver, and a microprocessor configured to report a graphical pass or fail indication on the display, including a threshold corresponding to the detected first sensor information and user inhalation data corresponding to the second sensor signal. A dry powder inhaler; a microprocessor, a wireless transceiver, and a first sensor for detecting pressure differential information in the region or part of the inhaler; and a second pressure sensor for detecting a signal generated from the inhaler during use and communicating with the first sensor through a pressure equalizing channel; the first and second pressure sensors each generate at least one signal, which is processed by the microprocessor to become a customized microprocessor output, and the microprocessor output is compared with a graph of pre-determined profile values for the inhaler type to generate a graphical display of the pressure-time curve characteristics of the inhalation operation performed by the user. The dry powder inhaler monitoring and detection system may further include a remote processing system including a display, a wireless transceiver, and a microprocessor configured to report a graphical pass or fail indication on the display, including a threshold corresponding to the detected first sensor information and user inhalation data corresponding to the second sensor signal. A dry powder inhaler; a microprocessor, a wireless transceiver, and a first sensor for detecting pressure differential information in the region or part of the inhaler; and a second pressure sensor for detecting a signal generated from the inhaler during use and communicating with the first sensor through a pressure equalizing channel; the first and second pressure sensors each generate at least one signal, which is processed by the microprocessor to become a customized microprocessor output, and the microprocessor output is compared with a graph of pre-determined profile values for the inhaler type to generate a graphical display of the pressure-time curve characteristics of the inhalation operation performed by the user. The dry powder inhaler monitoring and detection system may further include a remote processing system including a display, a wireless transceiver, and a microprocessor configured to report a graphical pass or fail indication on the display, including a threshold corresponding to the detected first sensor information and user inhalation data corresponding to the second sensor signal. A dry powder inhaler; a microprocessor, a wireless transceiver, and a first sensor for detecting pressure differential information in the region or part of the inhaler; and a second pressure sensor for detecting a signal generated from the inhaler during use and communicating with the first sensor through a pressure equalizing channel; the first and second pressure sensors each generate at least one signal, which is processed by the microprocessor to become a customized microprocessor output, and the microprocessor output is compared with a graph of pre-determined profile values for the inhaler type to generate a graphical display of the pressure-time curve characteristics of the inhalation operation performed by the user. The dry powder inhaler monitoring and detection system may further include a remote processing system including a display, a wireless transceiver, and a microprocessor configured to report a graphical pass or fail indication on the display, including a threshold corresponding to the detected first sensor information and user inhalation data corresponding to the second sensor signal. A dry powder inhaler; a microprocessor, a wireless transceiver, and a first sensor for detecting pressure differential information in the region or part of the inhaler; and a second pressure sensor for detecting a signal generated from the inhaler during use and communicating with the first sensor through a pressure equalizing channel; the first and second pressure sensors each generate at least one signal, which is processed by the microprocessor to become a customized microprocessor output, and the microprocessor output is compared with a graph of pre-determined profile values for the inhaler type to generate a graphical display of the pressure-time curve characteristics of the inhalation operation performed by the user. The dry powder inhaler monitoring and detection system may further include a remote processing system including a display, a wireless transceiver, and a microprocessor configured to report a graphical pass or fail indication on the display, including a threshold corresponding to the detected first sensor information and user inhalation data corresponding to the second sensor signal. A dry powder inhaler; a microprocessor, a wireless transceiver, and a first sensor for detecting pressure differential information in the region or part of the inhaler; and a second pressure sensor for detecting a signal generated from the inhaler during use and communicating with the first sensor through a pressure equalizing channel; the first and second pressure sensors each generate at least one signal, which is processed by the microprocessor to become a customized microprocessor output, and the microprocessor output is compared with a graph of pre-determined profile values for the inhaler type to generate a graphical display of the pressure-time curve characteristics of the inhalation operation performed by the user. The dry powder inhaler monitoring and detection system may further include a remote processing system including a display, a wireless transceiver, and a microprocessor configured to report a graphical pass or fail indication on the display, including a threshold corresponding to the detected first sensor information and user inhalation data corresponding to the second sensor signal.

[0104] In one embodiment, the dry powder inhaler monitoring and detection system further includes a removable inhaler accessory device that is attached to or connected to the inhaler and includes a body on which the microprocessor, wireless transceiver, and sensor are disposed. In one embodiment, the dry powder inhaler monitoring and detection system further includes a removable inhaler accessory device that is attached to or connected to the inhaler and includes a body on which the microprocessor, wireless transceiver, and sensor are disposed. In one embodiment, the dry powder inhaler monitoring and detection system further includes a removable inhaler accessory device that is attached to or connected to the inhaler and includes a body on which the microprocessor, wireless transceiver, and sensor are disposed.

[0105] A method for monitoring and detecting accurate data useful for training an inhaler user is also provided , the method comprising: displaying an instruction to load a drug into an inhaler; reading drug data related to the drug or inhaler information and associating the data with a corresponding threshold value; displaying an instruction to initiate an inhalation operation; identifying pressure difference data during inhalation by the user; determining whether the user has passed or failed the inhalation operation based on whether the threshold value is met or exceeded, or whether the achievement of the threshold value has failed. In one embodiment, the method further comprises including steps of transmitting and displaying an indication of whether the user has passed or failed the inhalation operation, and transmitting and displaying the steps including displaying on a processing system such as a smartphone, tablet, computer or other wirelessly communicable device; and transmitting and displaying the steps including wirelessly transmitting the drug data and the pressure difference data to the processing system, and displaying, by the system, a pressure-versus-time curve together with a threshold value corresponding to the drug data. In some embodiments, the corresponding threshold value is a predetermined value set for the inhaler type after removing background noise .

[0106]

Example

[0106] Example 1 Use of an integrated training device A 60-year-old type 1 diabetic patient has an elevated hemoglobin A1c and is considered out of control, so is instructed to administer inhaled insulin provided by a dry powder inhalation system for dietary therapy. The patient uses an insulin pump for basal insulin . The patient uses a removable inhalation accessory device as shown in FIGS. 3-5 and is as shown in FIG. 1 ​​is trained regarding wireless inhalation using a device. The patient is provided with the device and is required to take deep and rapid breaths when using the trainer device (which may or may not contain medicine).

[0107] The pressure sensor of the inhalation device is used to detect the pressure drop during inhalation, and the data is transmitted to a Bluetooth-enabled tablet with a relevant application. A color detection sensor detects the color of the cartridge (filled or empty with the substance), and uses the data to identify a threshold region regarding the minimum inhalation pressure. The data is collected on a tablet having a programmed application that can read the radio wave signal from the device, and the patient can view the data in real time on the display screen. The patient's first inhalation attempt is too slow and is displayed on the screen as entering the red "unacceptable region" of FIG. 12 (Region B). The patient is instructed to take another rapid breath, which is slightly faster and deeper than the previous attempt. When the inhalation is completed, the graph shows that the patient's inhalation operation is acceptable and overall lies in the acceptable region (Region C) of the graph of FIG. 12. As the patient gets used to the training, the use of a similar inhaler filled with medicine becomes reliable.

[0108] The patient is prescribed a dry powder inhaler similar to the type shown in FIG. 1 and a cartridge filled with various doses of inhalable insulin for the treatment of the patient's diabetes. Six months after prescribing the inhalable insulin, the patient's diabetes is diagnosed as being controlled.

[0109] Example 2 Use of a detachable / removable training device:​​​​​​​​​ A 59-year-old type 2 diabetic patient is instructed to administer inhaled insulin from a dry powder inhalation system. The patient requested the inhalation system for its convenience. The patient is trained regarding wireless inhalation using a device such as shown in Figure 1. The patient is provided with the device of Figure 1 equipped with a detachable inhaler device similar to those of Figures 3 - 5 and is required to take deep and rapid breaths when using the training device. Examples of inhalation operations performed by the subject are shown in and described above with reference to Figures 23, 24, 25, and 26. Pressure and color identification data are collected on a mobile phone, and the patient can view the data in real time on the display screen. The patient's first attempts are acceptable as shown by the threshold vs. inhalation data graphed or otherwise visibly displayed as a result of the software.

[0110] With practice during training, the patient becomes more certain in using the device.

[0111] The patient's detachable sensor is removed from the dry powder inhaler. The patient is provided with a dry powder inhaler and a cartridge filled with inhalable insulin for the treatment of the patient's diabetes. Six months after prescribing inhaled insulin, the patient's diabetes is diagnosed as being controlled, and the patient comments that the device is very convenient.

[0112] The above disclosure is of illustrative embodiments. Those skilled in the art will appreciate that the techniques disclosed herein will reveal representative techniques that function well in the practice of this disclosure. However, those skilled in the art will recognize, in light of this disclosure, that many modifications can be made to the specific Although it can be done in the embodiments, without departing from the spirit and scope of the present disclosure, similar or the same It should be understood that the results can be obtained.

[0113] Unless otherwise indicated, all numerical values representing the amounts, properties, examples such as molecular weight, reaction conditions, etc. used in this specification and the claims are, in all cases, understood to be modified by the term "about". Therefore, unless otherwise indicated to the contrary, the numerical parameters described in this specification and the appended claims are approximate values that can vary depending on the desired properties to be obtained. At least, and without intending to limit the application of the concept of equivalents of the claims, each numerical parameter should be considered in light of at least the reported significant digits and by applying ordinary rounding techniques. Although the numerical ranges and parameters described in the broad scope of the disclosed embodiments are approximate values, the numerical values described in specific examples are reported as accurately as possible. However, any numerical value inherently includes certain errors that inevitably result from the standard deviation found in their respective test measurements.

[0114] The terms "a", "an", "the" and similar referents used in the context of describing the disclosed embodiments (in particular, the context of the following claims) are considered to cover both the singular and plural forms unless otherwise indicated in this specification or clearly contradicted by the context. The reference to a range of values in this specification merely serves as a concise way of individually referring to each separate value that falls within that range. Unless otherwise indicated in this specification, each separate value is incorporated into this specification as if it were individually listed herein. ​ be incorporated. All methods described in this specification, unless otherwise indicated herein or unless the context clearly dictates otherwise, can be performed in any suitable order obtained. Any and all examples provided herein, or the use of exemplary language (e.g., "such as," "for example") are merely for the purpose of making the disclosed embodiments more clear and do not limit the scope of the claimed embodiments in any other way. The language of this specification should not be construed as indicating any non-claimed element as essential to the practice of the disclosed and contemplated embodiments.

[0115] The specific embodiments disclosed herein can be further limited within the scope of the claims by using language consisting of or essentially consisting of When used in the claims, whether as filed or added by amendment, transitional terms such as "consisting of" exclude any element, step, or ingredient not specified in the claims. The transitional term "essentially consisting of" limits the claims to a particular material or step and those that do not materially affect the basic and novel characteristics Thereby so claimed embodiments are enabled and essentially or explicitly described herein. The grouping of alternative elements or embodiments disclosed herein is not considered limiting Each group member can be referred to and claimed individually or in any combination with other members of the group or other elements found in this specification

[0116] For reasons of convenience and / or patentability, one or more members of the group may be included in the group or in any combination with other members of the group or other elements found in this specification or excluded from the group. ​​It is understood that any such inclusion or deletion may be included in or deleted from the present disclosure. Whenever a reference is made to a group, the specification is deemed to include the group as so modified. Therefore, the Markush Group's specification as used in the appended claims is fully understood to be accurate. Add.

[0117] Some embodiments are contemplated by the authors of this disclosure for carrying out the disclosed and contemplated embodiments. The present invention is described herein, including the best mode known in the art. and variations on these described embodiments will be apparent to those skilled in the art. It is expected that those skilled in the art will make appropriate use of such variations, and the authors have disclosed and considered them. It is to be understood that the embodiments described herein may be practiced otherwise than as specifically described herein. Accordingly, the embodiments disclosed and contemplated herein may be used in accordance with the principles of the present invention as permitted by applicable law. All modifications and equivalents of the subject matter recited in the appended claims are included. Any combination of the above-described elements in any variation thereof is contemplated unless otherwise indicated herein. To the extent permitted by law or otherwise clearly contradicted by context, all such disclosures are included herein.

[0118] Additionally, numerous patent and publication references are made throughout this specification. Each of the above references and publications is herein individually incorporated by reference in its entirety.

[0119] In closing, the embodiments disclosed and contemplated herein demonstrate the principles of the invention as conceived. It is to be understood that the present invention is merely illustrative and that other modifications that may be used are within the scope of this disclosure. Thus, by way of example, and not of limitation, alternative configurations may be implemented in accordance with the teachings herein. It may be used in accordance with this. Therefore, the disclosed embodiments are not precisely limited to those illustrated and described. It is not limited thereto.

Claims

1. A system for monitoring and detecting accurate data useful for training a dry powder inhaler user, comprising: A display for displaying an instruction to load a drug into the inhaler; A first pressure sensor for detecting the pressure around the inhaler; A second pressure sensor for detecting a pressure drop in the flow path of the inhaler; A pressure equalizing channel disposed between the first pressure sensor and the second pressure sensor for communicating air between the first pressure sensor and the second pressure sensor; A control unit for reading drug data related to drug information or inhaler information and associating the data with corresponding thresholds; The first pressure sensor is an absolute pressure sensor for detecting the pressure of the air in the pressure equalizing channel; The second pressure sensor is a differential pressure sensor for detecting the pressure difference between the air in the flow path of the inhaler and the air in the pressure equalizing channel; The control unit: Displays an instruction to start an inhalation operation; Identifies pressure difference data during inhalation by the inhaler user; Determines whether the inhalation operation of the inhaler user is qualified or unqualified regarding whether the corresponding threshold is met or exceeded, or whether the achievement of the corresponding threshold has failed.

2. The system according to claim 1, wherein the control unit further transmits and displays an instruction as to whether the user has passed or failed the inhalation operation.

3. The system according to claim 2, wherein when transmitting and displaying, the control unit displays on a processing system such as a smartphone, a tablet, a computer, or other wireless communication-capable device.

4. The system according to claim 3, wherein when transmitting and displaying, the control unit transmits the drug data and the pressure difference data to the processing system by wireless transmission, and displays a pressure vs. time curve together with the threshold corresponding to the drug data on the processing system.

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