Apparatus, system, and method for detecting and monitoring inhalation

Abstract

To provide an inhaler accessory apparatus and method for sensing and measuring real-time characteristic patterns of a subject's use of a dry powder inhalation system.SOLUTION: An inhaler device can be used in a wireless communication mode to communicate with a display to assess the subject's usage of the inhalation system concurrently with the inhalation, and thus, the subject's inhalation and the performance of the inhalation system can be evaluated. The system can also detect the identity of the medicament, its dosage, lot, expiration, etc. and the characteristic profile of a dry powder formulation emitted from the inhalation system in use, and allows effective delivery of powder doses. Data obtained can be transmitted to a digital application and can be analyzed for optimal therapeutic utility.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 on April 24, 2018 , the entire content of which is incorporated herein by reference.

[0002] The present specification describes an interactive apparatus and method for recording, transmitting and displaying physical measurements based on real-time physiological conditions generated by an inhaler and / or a subject during an inhalation operation. Background Art [Background Art]

[0003] Inhalers for pulmonary delivery of therapeutic substances via the airways, particularly for the treatment of local or systemic diseases, are commercially available. For example, nebulizers , which are devices containing a propellant, and dry powder inhalers have been used in the treatment of diseases such as asthma, respiratory tract infections, and systemic diseases like diabetes. In the treatment of diseases, the efficiency of delivering a required dosage of a therapeutic substance to a patient depends on the efficiency of the device, and the overall efficiency can be improved

[0004] by providing an appropriate feedback mechanism to the patient, clinician or physician during use of the device, for example, to teach the patient appropriate inhalation technique. Improper use of the device and poor inhalation technique can lead to lack of efficacy in the treatment of the disease. For example, administering a lower or higher dosage of a therapeutic substance than intended can be harmful to the patient. In order to effectively deliver a therapeutic substance to the airways, the patient or user may be trained or instructed to use the device appropriately.

[0005] ​​​​Dry powder inhalers, used to deliver medication to the lungs, typically contain a single dose of powder. The powder formulation can be supplied in bulk, or in hard gelatin capsules, cartridges, or blisters. Quantified into multiple individual doses stored in a unit dose compartment such as a pack. In any of the following states, including: Drug administration reproducibility means that the formulation is uniform and that it is consistently reproducible. It is necessary that the dose can be delivered to the patient with a certain result. Therefore, the drug administration requires the formulation to be resolved. This can be improved by optimizing the dosage, which, for example, can help patients achieve the necessary medication. This is achieved by ensuring proper inhalation techniques are performed.

[0006] The pulmonary tract is used to properly deliver therapeutic substances to the patient. Equipment for training personnel is described, for example, in U.S. Patent No. 5,333,106. This paper uses intake steps in the appropriate order and is based on airflow versus volume data. This system interactively instructs patients using aerosol inhalers, including those with feedback displays. An apparatus for kneading is disclosed. U.S. Patent Application No. 10 / 759,859 (U.S. (National Patent Application Publication No. 2004 / 0187869) describes a drug inhaler, for example, a dry pallet. A training device for a suction device is disclosed, which measures the pressure difference and also Using a Lypowder inhaler simulator, we can analyze both the inhalation rate and the peak inhalation flow rate. It is based on displaying a single corresponding value.

[0007] U.S. Patent No. 8,499,757 and U.S. Patent No. 8,636,001 (Dry All teachings relating to powder inhalers are incorporated herein by reference in their entirety. Dry powder inhalers and cartridge systems, such as those described in ( ), By deagglutinating the powder formulation inside the inhaler and capsule or cartridge, Primary drug particles or suitable feather-like inhaled smoke may be generated during the inhalation process. The benefits of delivery are numerous, including rapid entry into the arterial circulation and initial metabolism by the liver. Avoiding drug degradation during multiple passes and ease of use, compared to other routes of administration such as injection. This includes the absence of discomfort. These devices have been used in clinical settings and are currently It is available commercially.

[0008] An interactive device and method for profiling inhalation effort, U.S. Patent No. 9,364, This is disclosed in Specification No. 619, which is incorporated herein by reference. [Overview of the project] [Problems that the invention aims to solve]

[0009] In this technical field, the aim is to maximize accuracy and ensure proper use of the inhalation system. The training and effort required are minimal, and during use of the inhalation system, and their Improvements to the design and manufacture of inhalers for monitoring patients throughout the entire care process, as well as medications Reusability of the packaging and the entire system, including the inhaler and parts of the inhaler. There is a need for improved flexibility of application. This disclosure provides an apparatus that achieves these goals. And present the methods. [Means for solving the problem]

[0010] This specification provides for detecting and measuring intake characteristic parameters of an intake system in use. An interactive device, said interactive device comprising an inhaler and patient instructions for use of the inhaler in combination with the device is described. In the disclosed embodiments, the device and the method of using the device are for example directed to the target's characteristic inhalation profile, that is, in sensing, detecting, measuring and monitoring the breathing pattern, collecting data generated from the inhalation operation by a subject, and for use in a treatment regimen, the effort required to deliver an appropriate dose or therapeutic dose using the inhaler provided to the subject is useful for identification. The device and method are also useful, for example, for training / teaching a subject to use an inhaler to effectively treat the subject's disease, disorder or condition, such that the subject receives an appropriate dose of the drug being delivered . In one embodiment, the device may comprise any inhaler, in particular a high-resistance dry powder inhaler, for delivering one or more pharmaceutically active ingredients or drugs to the lungs of the subject under treatment, and thus to the pulmonary circulation and systemic circulation . In some embodiments, the dry powder inhaler is breath-actuated, 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.

[0011] Exemplary embodiments of the inhalation devices and systems disclosed herein include an inhaler accessory device that is a separate device; the inhaler accessory device is adaptable or attachable to the inhaler, so that during use, it can be in close contact with or mounted on the inhaler, and can be removed from the inhaler after use .[+END]]

[0012] In some embodiments, a detection and monitoring system is provided, comprising an inhaler for use by a patient and a corresponding inhaler accessory device, wherein the inhaler accessory device is adapted to the inhaler Alternatively, the inhaler may be detached from the inhaler attachment so as to be compatible with each other. Alternatively, it may be made possible to disengage it, and the patient may use a device prescribed by a physician for inhalation. An inhaler is required and can be used for self-administration of a single dose of medication. The device consists of a main body structurally configured to engage with the inhaler prescribed to the patient, and, for example, Photodiode (LED) (e.g., power ON and battery charge status or other status) Display screens including touchscreens, or liquid crystal displays (LCDs), touchscreens or other interactive displays (these are small to fit in the inhaler accessory). (Can be typeset or remotely placed in other parts of the detection and monitoring system), visual An optional display means for displaying target signals, a microprocessor, and one or more sensors. -Includes an electronic board. In some embodiments, the inhaler accessory is from the inhaler. This includes a receiver and transmitter or transceiver for sensing the resulting signals, which may be wireless or wireless. By line, computers, personal digital assistants (PDAs), tablets, and / or mobile phones / smartphones It communicates with a phone, smartwatch, or smart glasses, and within the application or other This method allows information from the inhalation procedure performed by the patient or user to be collected in real time. , and simultaneously display. The inhalation device attachment is also preferably serial ( For example, it may include a USB port or other ports to enable data transfer and battery charging. I'll do that.

[0013] In some embodiments, an inhaler accessory is provided for attachment to the target inhaler. and; activating the inhalation device system; while the subject is inhaling, the inhalation device To monitor inhalation by the target and to ensure effective delivery of therapeutic agents to the respiratory system. To facilitate training and / or monitoring of the subject in order to achieve optimal or appropriate inhalation operation. A method is provided that includes the following: The detection and monitoring system can achieve optimal drug delivery. Therefore, in order to achieve a favorable flow profile for that individual, the appropriateness of the inhaler To facilitate training on the subject regarding its use. Apparatus and methods also include, for example, dosage during delivery; Quantification of the drug during delivery; duration of dose release during delivery; number of doses administered to the subject. To provide, to monitor the performance of the inhalation system provided to the patient, and in real time To monitor the mechanical integrity of the inhalation system and / or for future analysis, data is collected. It can be used to store data. In some embodiments, together with an inhaler accessory. The inhaler or parts of the inhaler that may be used (such as a cartridge) must have a code or identifier. This includes, for example, radio frequency identification (RFID), color coding, laser etching, and text. obtain.

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

[0015] In one exemplary embodiment, the apparatus is described, for example, 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, Specification No. 424,518 and Specification No. 8,636,001 (for dry powder inhalers) All disclosures relating to this are explained in (all of which are incorporated herein by reference). It can be adapted to high-resistance dry powder suction systems such as those used in such applications. The device is Dry powder inhalers with or without cartridges containing prescription formulations, electrical, electronic, One or more transducers including electromechanical, electromagnetic, photonic, or photovoltaic; for example, pressure Force sensors, temperature sensors, sound sensors, and optical sensors; signal conditioning circuits and / or It may include software programs, means for electronic signal communication, and output displays. In such exemplary embodiments, the device includes analog or digital sensors, amplification, and signal Appropriate signal regulators such as filtering or analog-to-digital conversion, and onboard processing units. Microprocessor, for subsequent signal processing, remote computer, tablet or wireless communication devices that communicate with mobile phones or personal digital assistants (PDAs), and / or real-time It can be used in conjunction with an output display. The device delivers the active ingredient to the pulmonary circulation. To deliver a pharmaceutical composition containing a pre-measured unit dose cartridge. It can be used for this purpose. In an alternative exemplary embodiment, the sensing and monitoring equipment may be empty or A dry powder inhaler equipped with a cartridge that can contain dry powder suitable for lung delivery. It can be adapted to be installed on or inside an inhalation system that includes it.

[0016] In one embodiment, the inhaler accessory is configured to be attached to or connected to the inhaler. The assembled body and; a microprocessor and at least two pressure sensors, for example, front A first pressure for detecting encrypted or coded information located in an area or part of the inhaler. Force sensor; and a second pressure sensor for detecting signals generated from the inhaler during use. -Optionally, the equalization channel between the first pressure sensor and the second pressure sensor The first pressure sensor and the second pressure sensor each have a minimum Both generate a single signal, which is processed by the microprocessor and customized The output of the microprocessor is reduced, and the output of the microprocessor is used Once the inhalation operation is complete, a pass or fail indicator is generated. In one embodiment, The attachment device generates a graphical display of the pressure-time curve characteristics of the suction operation performed by the user. Furthermore, the user's performance is determined by a predetermined ideal profile for each inhaler type. Includes a microprocessor that compares the values ​​to a graph.

[0017] In another embodiment, the inhalation device accessory includes a first pressure sensor and a second pressure sensor. This includes the fact that these are digital sensors, and their outputs are in digital format. In this embodiment, an inhalation device is configured, and the second pressure sensor is an analog sensor. Furthermore, its output is in analog format, and the device also adjusts the sensor signal, Includes additional circuitry for filtering, amplification, and / or conversion to digital format. The second pressure sensor can detect a pressure drop measured in the flow path within the suction device, and In other words, it can detect atmospheric pressure. In some embodiments, the inhaler accessory further includes a voice Sound sensors that detect acoustic signals, including signal amplitude, audio signal frequency, or combinations thereof. The sound sensor may include a hiss, and the sound sensor is a microphone. In an alternative embodiment, an inhaler is attached. The device detects the color of multiple parts of the inhaler, the inhaler cartridge, or other medication packaging. A laser beam configured to include a Doppler sensor and an infrared sensor. Includes sensors or other sensing beams.

[0018] In certain embodiments, the inhaler accessory includes a cartridge and a dry powder formulation. , including a dry powder inhaler. In one embodiment, the dry powder formulation is diketopipera The inhalation device contains gin and at least one active ingredient, and the inhalation device attachment has at least two cells The device includes a sensor, one of which detects a pressure difference, and the differential pressure sensor is located within the suction device. Furthermore, it detects the pressure drop measured in the absolute pressure sensor used in conjunction with the differential pressure sensor, and determines the necessary In such cases, adjustments are made with respect to atmospheric conditions before identifying a pressure drop. In certain embodiments The inhaler attachment device is a pressure equalizer for equalizing the pressure inside the inhaler with the environment. Includes a channel. Without a pressure equalization channel, the accuracy of pressure measurements will be inconsistent and unreliable. Because this is not possible, the measurement process becomes inefficient.

[0019] The inhaler accessory device also includes the inhaler cartridge or other medication package loaded into the inhaler. A color detection sensor to detect the color of the page, a cartridge or other medication loaded into the inhaler. An RFID reader for reading the RFID tag inside the package, and an inhaler or similar device. or letters, codes, or text provided on the inhaler cartridge or other medication packaging. It includes one or more image detection sensors capable of identifying information. In some embodiments, The inhaler attachment also remotely receives data from at least two sensors. Includes a wireless transceiver that transmits to the processing system. The inhaler accessory also further includes an electronic battery. The code (microprocessor, sensors and wireless transceiver are connected to the electronic board) (and / or placed on an electronic board), and a visible indicator or user-indicates pass / fail status. It may include a display that shows the information. In some embodiments, the microprocessor including customized threshold data for the signal generated by the first pressure sensor. It may have a customized microprocessor output unit, and also allows for patient inhalation and It may have an output unit that generates a pressure-time curve on the display at times or immediately afterward. In the application configuration, the inhalation device accessory includes, for example, multiple parts of the inhaler, a capsule, and a cartridge. A statistical algorithm for color classification, including a color-coded object detection algorithm, including a color-coded object detection algorithm. Using luminosity, these colors are identified by capsule / cartridge type and color. It is used to correlate information such as the strength of the dosage provided by the drug.

[0020] In an alternative embodiment, the dry powder inhalation monitoring and detection system is configured to detect dry powder inhalation. Insertion device; microprocessor, wireless transceiver, and dark area or part of the inhaler. A first pressure sensor for detecting coded or encoded information; and an inhaler for use. A second sensor detects the signal generated from the first sensor and communicates with the first sensor through the pressure equalization channel. Includes a pressure sensor; the first and second pressure sensors each have at least one The signal is generated, and the signal is processed by the microprocessor to create a customized machine. The output becomes a microprocessor output, and the microprocessor output is used for the user's inhalation operation. Once the process is complete, an "pass" or "fail" indicator is generated. In this embodiment, dry powder The inhalation monitoring and detection system further includes a display, a wireless transceiver, and the detected first A threshold corresponding to the pressure sensor information of the first pressure sensor, and user inhalation data corresponding to the second pressure sensor. The system should display a graph on the screen indicating whether the result is pass or fail, including whether it is a "T" or "F" result. Includes a remote processing system, including a configured microprocessor.

[0021] Dry powders containing fine particles suitable for lung delivery are, for example, U.S. 8,499,7 Specification No. 57 and Specification No. 8,636,001 (all disclosures relating to fine particles) With regard to such technology, including that disclosed in (the entirety of which is incorporated herein by reference), It is well known in the field of technology. In each exemplary embodiment, dry powder, effective ingredients The components are proteins, peptides, or polypeptides, and combinations thereof, for example, Secretory hormones, such as insulin, glucagon-like peptide 1 (GLP-1), and parathyroid glands. It may be a hormone or an analogue thereof.

[0022] In some embodiments, the dry powder formulation for delivery to the pulmonary circulation is a peptide, Active ingredients or active agents containing proteins, hormones, their analogues, or combinations thereof It contains, and the active ingredients are insulin, calcitonin, growth hormone, treprostinil, and Lonosetron, tobramycin, filgastrin, erythro Poietin, granulocyte-macrophage colony-stimulating factor (GM-CSF), chorionic gonadotropin Ropin-releasing factor, luteinizing hormone-releasing hormone, follicle-stimulating hormone (FSH), vasoactive intestinal Peptides, parathyroid hormones (including blackuma PTH), parathyroid hormone-related proteins Quality, glucagon-like peptide-1 (GLP-1), exendin, Ramrintide, oxytomodulin, peptide YY, deoxyribonuclease 1, i Interleukin 2-inducible tyrosine kinase, Bruton's tyrosine Kinase (BTK), inositol-required kinase 1 (IRE1), or its analogues, active Sexual fragment, PC-DAC-modified derivative, or its O-glycosylated form, epi Contains nephrine, an antibacterial agent or an antifungal agent. In certain embodiments, a pharmaceutical composition or dry powder The drug contains fumaryldiketopiperazine, and its active ingredients are insulin and parathyroid glands. Hormone 1-34, GLP-1, oxytomodulin, peptide YY, heparin, epithelium Small body hormone-releasing peptides (PTHrP), neurotransmitter agonists and antagonists, for example, 5 - Hydroxytryptamine receptor agonists and antagonists, prostacyclins, i.e., PGIs 2. One or more selected from epinephrine, norepinephrine, and their analogues.

[0023] In one exemplary embodiment described herein, the apparatus includes a dry powder inhaler and It includes a communication sensor, which receives pressure generated from the dry powder suction system. It can detect at least one signal type, including force signals, flow signals, temperature signals, and audio signals. and the signal can be transmitted to at least one device for analysis, storage, printing, or display. In such exemplary embodiments, the sensor is configured within the dry powder inhaler. It can be adapted for use with dry powder inhalers, and the sensor can be a microphone. ru.

[0024] In an exemplary embodiment, the intake system has high resistance to the airflow and per minute Approximately 0.065 (√kPa) / liter to approximately 0.200 (√kPa) / liter per minute Includes a dry powder inhaler having a resistance value. The high-resistance inhalation system includes a sensing and monitoring device. It may be equipped with a sensor. In some embodiments, the sensor is generated by the inhalation system in use. The resulting unique characteristic signal can be detected. In another exemplary embodiment, the sensor is a sound sensor. This means that the audio signal is transmitted in wired or wireless mode to at least one of the systems. This specification includes a sound detection device or microphone configured to transmit to another device. The sensing and monitoring device for dry powder inhalers described in the book also uses audio signals, etc. A microprocessor configured to analyze and process at least one of the signals It can be associated with an analog-to-digital converter that communicates with the server. In another exemplary embodiment... At least one of the devices is an analog-to-digital converter.

[0025] In one exemplary embodiment, a monitoring system for a dry powder inhaler is described, and the monitoring system The system includes: monitoring equipment containing at least one sensor; analog-to-digital converter; data Including a data storage medium, the data storage medium is processed by a processing device to execute the algorithm. The algorithm includes an executable set of machine-readable instructions, and the algorithm is: from at least one sensor Steps to receive data; Steps to filter data; Steps to transform data Steps: a step to analyze data; and a step to monitor patients using the data. 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 , in any part of the inhaler, for example, inside the airflow conduit, inside the wall of the inhaler, or in a separate piece And provided outside the inhaler. In another exemplary embodiment, the monitoring device is dry powder It can be a removable device that can be attached to or mounted on the suction device. In another exemplary embodiment, the monitoring device is a graph table which is a real-time graphical representation of the inhalation. Provides a demonstration.

[0027] In another exemplary embodiment, the audio signal includes the amplitude of the audio signal, the frequency of the audio signal, or this. These are combinations. In yet another exemplary embodiment, the sensor is further different Measure at least one audio signal of a frequency. In another exemplary embodiment, dry powder The inhaler further includes a cartridge, and the cartridge contains dry powder for lung delivery. It may contain uder. Furthermore, the dry powder contains diketopiperazine fine particles and at least It may also contain one active ingredient. In yet another embodiment, at least one drug is an insulin Phosphorus, GLP-1, parathyroid hormone, calcitonin, its analogues, or combinations thereof Includes.

[0028] In further embodiments, the sensing and / or monitoring equipment detects a signal from the dose being delivered. It is configured in such a way. In this embodiment, the sensing and monitoring system receives from the cartridge From the start of Udar delivery to the end of powder particle delivery, the inhaler and cartridge being used The sensor can detect the movement of powder particles within the stem, and it also detects the sound and inhalation system of the inhaler. The system detects changes in the inherent sound characteristics of the powder particles produced. The data obtained from the detection is then processed. The amount of drug analyzed and released or delivered from the inhalation system, and the course of dose delivery. This can be correlated with time and the performance of the inhalation system.

[0029] In another exemplary embodiment, the sensing and monitoring device is adaptable to a dry powder inhaler. The device may be provided as a removable component, such as an exterior or saddle structure. In this embodiment, Furthermore, detachable devices do not modify the structure or form of the dry powder inhaler, To facilitate the use of the inhalation system. Therefore, once the characteristics and performance of the inhaler are determined and If the elephant can use it properly, the same inhaler can be used without an outer casing. In this embodiment, the sensor, such as a small microphone, is enclosed in, for example, an outer casing or adapter. In any area of ​​the exterior, including being embedded in the wall or protruding from the exterior wall It can be arranged in combination. In this embodiment, the sensing and monitoring device is used for dry powder inhalation during use. It provides greater resolution to the sonic characteristics resulting from the components and cartridge system.

[0030] One embodiment describes a method for measuring a pressure difference during an inhalation operation. The law is: to provide an inhaler to a subject, the inhaler is an audio signal generated from the inhaler At least one amplitude, at least one frequency of the audio signal, or a combination thereof. It includes a sensor configured to detect, and to allow the subject to inhale for at least 1 second. and; using algorithms provided to the microprocessor in the computer system and at least one amplitude of the audio signal, at least one frequency of the audio signal, or Analyze these combinations and generate datasets; as well as in accordance with time and pressure This includes displaying, printing, or storing datasets.

[0031] In further embodiments, this specification includes a monitoring system for a dry powder inhaler. The monitoring system includes: an acoustic sensor, and at least one sensor including a Doppler sensor. This includes monitoring equipment; analog-to-digital converters; and data storage media, the data storage media being A It includes a set of machine-readable instructions that can be executed by a processing device to perform a algorithm, The algorithm is: a step of receiving data from at least one sensor; and a step of processing the data. Steps to perform data conversion; steps to transform data; steps to analyze data; and A monitoring system that includes steps to monitor patients using data, including instructions to manipulate data, The stem is explained.

[0032] Furthermore, in some embodiments, as specified herein, the pressure difference is measured during the suction operation. A method comprising: providing an inhaler to a subject, wherein the inhaler is generated from the inhaler At least one amplitude of the audio signal, at least one frequency of the audio signal, or a combination thereof. Includes a sensor configured to detect a mismatch, and inhales the target for at least 1 second. To cause; to use an algorithm provided to the computer system to reduce the amount of audio signal At least one amplitude, at least one frequency of the audio signal, or a combination thereof To analyze and generate datasets; and to display the datasets according to time and pressure. Methods including printing or storing are described.

[0033] In other embodiments, this specification includes an interaction for monitoring inhalation performed by the user. A dry powder inhalation system of the type: at least one microprocessor, air Alternatively, it may include a Doppler effect sensor and / or an infrared sensor capable of measuring gas flow. An inhaler accessory including one or more active sensors; a dry powder inhaler, Recognition is performed using sensory beams including laser beams, RFID, optical recognition, and image sensors. Possible type identifiers, e.g., color, laser etching, printed numbers; printed words It includes a cartridge, and the sensory beam detects color, type of dose, and dose, etc. A dry powder inhaler that can detect an identifier code integrated into the cartridge. An interactive dry powder inhalation system is described, which includes an image detection sensor that detects light. To detect dosage or other identifiers using formula character recognition, onboard calculation or remote It can be used in conjunction with calculations. In some embodiments, the dry powder inhaler is used per minute 0.065 (√kPa) / liter to 0.200 (√kPa) / liter per minute Flow resistance value; Transduction device configured to detect a signal generated from the inhaler in use. It is configured to display inhalation operations performed by the user in real time. It has a display device. In another embodiment, the transducer has a pressure in the suction device It senses and measures the difference. Furthermore, the transducer controls the air guide of the dry powder inhaler. A flow meter may be configured to sense and measure the flow rate through a pipe. For example, a device configured to sense and measure audio signals generated from within the inhaler. It could be called an ICROphone.

[0034] In yet another embodiment, this specification includes sensing and monitoring suitable for dry powder inhalers. A device that is structurally configured to fit a dry powder inhaler, and is removable Includes the device; the removable device generates in the dry powder suction device Includes a microphone for detecting sound; and a dry powder inhaler, 0 per minute Flow rate of 0.065 (√kPa) / liter to 0.200 (√kPa) / liter per minute A sensing and monitoring device that possesses resistance is described.

[0035] Furthermore, in some embodiments, sensing and monitoring equipment for dry powder suction systems The dry powder inhalation system includes a dry powder inhaler and a cartridge. Furthermore, the sensing and monitoring equipment detects dry powder released from the dry powder intake system. A sensing system including a microphone configured to detect audio signals generated from a formulation. The monitoring equipment is described.

[0036] In some embodiments, the dry powder suction device includes a housing, a movable member, and a mouse The movable part, including the spiece, moves the container from the powder containment position to the dispensing position. It is configured to be operable in this way. In this embodiment and other embodiments, the movable member is an intake It may be configured as part of the lid assembly at the proximal end of the device, and in the cartridge mounting area It forms a part. In this embodiment, the mouthpiece is formed when the lid or inhaler is closed. It is integrally constructed with the cover portion that covers the housing over the upper part of the ridge mounting area. The downward movement of the piece from the horizontal plane causes the lid or cover to be positioned vertically in the angular direction. Move it to the position to open the inhaler, providing access to the inside of the inhaler and the cartridge. To allow insertion and removal. Conversely, the upward direction from the vertical plane of the mouthpiece to the horizontal plane. Movement in this direction causes the inhaler to close, and the inhaler and cartridge mounting area may be affected. An opening for an air passage is automatically created between the inserted cartridge and the device.

[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 accepts and holds the cartridge, and the inhaler When the device is moved from the open position to the closed position, metering, dispensing, or dose delivery is performed from the containment position. Structurally configured to have a mechanism that is operable to reconfigure to a position In several versions of this embodiment, the mechanism also allows the inhaler to be opened after use. When removing a used cartridge, the cartridge installed in the inhaler should be placed in the dispensing position. It can be reconfigured from the placement to the containment position. In some embodiments, the mechanism allows the cartridge to After use, it can be reconfigured into a disposable or discardable form.

[0038] In some embodiments, the body of the inhaler includes a proximal portion including a mouthpiece, and a body, Structurally designed as a removable cover that covers multiple parts of the main body and the upper part of multiple internal components of the inhaler. The housing includes a distal portion including a housing; the housing has a distal end and a proximal end It includes, and the proximal end has an opening that fits into and seals the portion of the inhaler body. In some embodiments, the proximal end contacts or abuts against the inhaler body to allow the inhaler to move externally. It shuts out from the environment. The inhaler, from its closed state, moves distally through translational motion from the housing to the main body. It opens by moving in a certain direction, and is used for inserting or removing the cartridge. and / or to achieve the withdrawal position. With the cartridge installed in the inhaler, distal or The translational motion of the housing from the main body in the proximal direction is a transition from containment to drug delivery. This causes the cartridge to move, and the cartridge container extends beyond the opening at the proximal end. The medication is pushed into the dispensing form by a projection formed inside the housing. The cartridge installed in the inhaler, when inhaled, contains the medication in the cartridge. An additional air passage is provided between the mouthpiece and the surrounding air to allow access to the dry powder. It is reconfigured to form a drug-dosing form. In this embodiment and other embodiments, the drug-dosing form is a The air passage of the cartridge has an intake port and an exhaust port that communicate with the air passage inside the mouthpiece. The mouthpiece has its own intake and exhaust ports.

[0039] In some embodiments, the body of the inhaler is a mouthpiece formed at the proximal end of the body. A cart installed in the inhaler includes an air conduit that communicates with the inside of the housing. The ridge's exhaust port can communicate directly with the surrounding air. The inhaler body also has a structure that allows for direct communication with the mouthpiece. It includes a continuous cartridge mounting area and has a distal and a proximal portion; proximal and distal The part forms a mouthpiece and a single piece and is insertable into the housing. In that embodiment, the main body and housing are separated to access the internal compartment. An open inhaler configuration can be realized for this purpose. In the open configuration of this embodiment, dry powder Cartridges containing the above can be inserted or installed within the cartridge mounting area of ​​the main unit, and the main unit The housing is pushed in or pulled out to open or close the inhaler. It may be released. In some embodiments, the housing can be moved from an open state to a closed state. It is movable along the upper distal end of the main body, and together with the inhaler, closes the cartridge. It forms an air conduit through the cartridge attached to the mounting area. In this configuration, the inhaler This is a substance that is released from the inhaler when inhaled orally by a user using a mouthpiece. This embodiment and dispensing method provides a dispensing method for the powder in the cartridge. The body and housing are in contact with each other and are securely fitted together by one or more anti-slip structures. They are joined together to prevent the inhaler from falling apart. An example of an anti-slip feature is snaplin. This is a warning or detent, which alerts the user that the inhaler is ready for use. It may produce sound to cause it. In some embodiments, the inhaler is substantially rectangular. Furthermore, the distal and proximal lengths are short; the movement of the housing across the main body is also short. , outward from the longer side (first side and second side) of the inhaler in the longitudinal plane By pulling or pushing the inhaler body which has an extended guide rail or track This occurs. In this embodiment, the inhaler body fits into the opening at the distal end of the housing. It is designed to have an opening at its distal end so that when inhaled, ambient air is drawn in. It guides you into the interior chamber of the device. The housing also guides you while it is moving. It is configured to have grooves or slots for sliding across the rail to fit snugly. Furthermore, it includes a stop end to prevent disassembly of the inhaler, and a dispensing type cartridge after installation. It includes a plunger for positioning the cartridge and closing the inhalation device. Move the top or container against the cartridge lid to create an air passage through the cartridge. It forms an aerosol of the powder in the cup, creating an intake and exhaust port, and during inhalation This enables the aerosolization process, allowing the aerosolized particles to be delivered to the inhaler mouthpiece and the user. In another embodiment, the plunger also places the cartridge assembly on the base of the mouthpiece. Move the lid so that it is positioned relative to the entrance opening. In one aspect of this embodiment The dry powder inhaler includes a housing containing a plunger, and the housing is a housing By moving the cartridge from an open state to a closed state across the inhaler body, Position the dagger so that it aligns with the mouthpiece.

[0040] In some embodiments, the dry powder suction device has a distal end and is connected to ambient air. Includes a housing configured with an opening for passage. In some embodiments, the housing The cover slides over the top of the inhaler body, effectively concealing a portion of the inhaler's body. It is configured in such a way that the housing moves in a translational motion above the distal end of the main body; the inhaler is 2 One form, the first position where the inhaler can be opened to access its internal compartment, the chamber; And a second position can be achieved where it contacts the proximal end to achieve closure of the inhaler. In the configuration, the distal portion of the housing is also movable in the horizontal plane relative to the proximal end. , extending distally, providing access to the internal compartment of the inhaler, and above it It extends and surrounds the inhaler body. In several versions of this embodiment, the housing The distal portion includes a parallel structure or flange for engaging with multiple parts of the body of the inhaler, Furthermore, for example, the main body of the inhaler is locked to the housing, and the two parts are fixed together and cast A fixation mechanism is formed to maintain the drug shape. In one embodiment, the distal portion of the housing Its distal end has an opening for communicating with the inside of the inhaler, and it slides on the body of the inhaler. An opening is provided which is configured as follows. The distal portion of the housing also has an outer surface, an inner surface, and It includes a chamber configured to slide on the inhaler body. In some embodiments, the far side of the inhaler The upper part has parallel wings to direct the airflow into the mouthpiece during inhalation. It includes an eel structure.

[0041] In alternative embodiments, the mouthpiece is provided by various mechanisms including movable members such as hinges. It engages with the body of the inhaler, and the cartridge lid is attached to the cartridge cup or container. It is integrally constructed by a movable assembly that includes a rack for moving relative to the element. The assembly accepts the cartridge installed in the inhaler and moves from the containment position to the dispensing position. It is configured to be reconfigured to a different position, and when the components of the inhaler move, for example, the device can be opened or closed. It can be designed to operate manually or automatically by closing it. In the configuration, the mechanism for reconfiguring the cartridge is attached to the mouthpiece and Includes a sliding tray or sled that is movably attached to the housing. In another embodiment, The mechanism is attached to or adapted to the inhaler, and, for example, integrally mounted within the hinge of the inhaler. Includes a geared mechanism. In yet another embodiment, the cartridge is accepted and sealed. A mechanism configured to operate to reconfigure from the loading position to the drug dispensing position is, for example, a housing. The cam includes a mechanism that allows the cartridge to be reconfigured as the ring or mouthpiece rotates. In this embodiment, the inhaler is released by angular rotation of the mouthpiece from the horizontal plane, Allows for the installation or removal of the ridge, and enables angular movement from the vertical plane to the horizontal plane of the mouthpiece. The movement closes the mouthpiece and automatically moves the cartridge from the containment position to the dispensing position. Reconfiguration is possible. In one embodiment, the gear mechanism in operation opens the inlet in the mouthpiece. The cartridge lid is positioned relative to the opening, and the cup is moved parallel to the dispensing position.

[0042] In some embodiments, the inhaler used by the subject is provided to the subject and the patient The inhalation profile activates the inhalation device and system and allows the patient to use the inhalation mouthpiece. By requiring the user to breathe using an inhaler attachment that is compatible with the inhaler, It is determined. Simultaneously with the patient's breathing, the inhaler attachment is detected and monitored by the system. Display the data, or an indicator related to such data, for the patient It is generated in real time from breathing. In this embodiment and other embodiments, the display This includes algorithmic applications for mobile phones, tablets, PDAs, or computers. This can be seen in the data, and this is a microwave radio signal transmitter and receiver, or transceiver. Devices such as Bluetooth®, Zigbee®, WiFi, S martWave, Z-Wave, or digital cellular networks such as 4G and 5G It communicates with a microprocessor on the inhaler attachment, including the cu, and microwave radio signals. It is detected by an application provided to a mobile phone that can communicate with the inhaler attachment. In one embodiment, microwave radio signals from the transceiver are transmitted to each other. To communicate, it can be transmitted from a microprocessor and transmitted within a computer. It may be received by the device. The inhaler attachment is a tablet, mobile device (PDA) or mobile phone In embodiments for communication, a tablet, PDA, or mobile phone is programmed with an app. This allows access to the application, which in turn allows screens to be screened via a graphical interface. It displays "lean," which, when switched on, communicates with the inhaler attachment and inhalation system. Any information / signal generated from the stem can be detected. [Brief explanation of the drawing]

[0043] [Figure 1] This shows an isometric view of an embodiment of a wireless dry powder detection and sensing device attached to an inhaler. [Figure 2] This shows an isometric view of an embodiment of a wired dry powder detection and sensing device attached to an inhaler. [Figure 3] This shows an isometric view of the top side of an embodiment of the wireless detection and sensing inhalation device accessory. [Figure 4] This shows an isometric view of the bottom side of an embodiment of a wireless detection / sensing inhalation device accessory, which includes an electronic board. [Figure 5] Figure 4 shows a top view of the electronic board. [Figure 6] This figure shows an isometric view of a dry powder inhaler coupled to an embodiment of a detection / sensing inhaler accessory, as shown in Figure 1, which includes an integrated signal display button. [Figure 7] Figure 2 shows an isometric view of a dry powder inhaler coupled to an embodiment of a detection / sensing inhaler accessory, including a local signal display button. [Figure 8] This is an isometric view of an embodiment of a wireless dry powder detection and sensing inhaler accessory device that is attached to an inhaler and includes an integrated display screen. [Figure 9] A block diagram of an overall embodiment of the wireless detection and monitoring system disclosed herein is shown. [Figure 10] A block diagram of an embodiment of the detection and monitoring system disclosed herein is shown. [Figure 11] A block diagram of another embodiment of the detection and monitoring system disclosed herein is shown. [Figure 12] The graph shows the inhalation techniques performed by the subjects, who were instructed to breathe in order to monitor the efficiency of inhalation for medication administration. [Figure 13] This specification shows a block diagram of an embodiment in which the inhaler attachment of the wireless detection and monitoring system disclosed herein includes a pressure sensor. [Figure 14] The block diagram shows an embodiment of the detection and monitoring system disclosed herein, in which the inhaler attachment includes a pressure sensor and a display. [Figure 15] The block diagram shows another embodiment of the detection and monitoring system disclosed herein, in which the inhaler attachment includes a pressure sensor and a visible indicator. [Figure 16] This specification shows a block diagram of an embodiment in which the inhaler attachment of the wireless detection and monitoring system disclosed herein includes a color detection sensor and a pressure sensor. [Figure 17] The block diagram shows an embodiment of the detection and monitoring system disclosed herein, in which the inhaler attachment includes a color detection sensor and a display. [Figure 18] The block diagram shows another embodiment of the detection and monitoring system disclosed herein, in which the inhaler attachment includes a color detection sensor and a visible indicator. [Figure 19] Figure 16 illustrates a method for training or monitoring a user's inhalation using the system shown. [Figure 20] This shows an isometric view of an embodiment of a wireless dry powder detection and sensing inhalation device. [Figure 21] Figure 20 shows an isometric view of the bottom side of an embodiment of the wireless dry powder detection and sensing inhalation device accessory. [Figure 22] Figure 20 shows an isometric view of the top side of an embodiment of the wireless detection and sensing inhaler accessory device attached to an embodiment of the inhaler. [Figure 23]This is a screenshot of a mobile phone display, showing a graph of a standard baseline curve, used to measure and monitor the inhalation effort of a subject during training to use a dry powder inhaler. [Figure 24] This graph shows that the resulting inhalation effort was satisfactory when the inhalation procedure was performed by subjects instructed to breathe in order to monitor the efficiency of medication inhalation. [Figure 25] This graph shows that the resulting inhalation effort from inhalation procedures performed by inexperienced subjects, who breathe to monitor the efficiency of medication inhalation, failed to meet the parameters required for proper use of the inhaler. [Figure 26] This graph shows that the resulting inhalation effort from inhalation procedures performed by inexperienced subjects, who breathe to monitor the efficiency of medication inhalation, failed to meet the parameters required for proper use of the inhaler. [Figure 27] Figure 13 illustrates a method for training or monitoring a user's inhalation using the system shown. [Figure 28] Figure 13 illustrates a method for training or monitoring a user's inhalation using the system shown. [Modes for carrying out the invention]

[0044] This specification describes the pressure or pressure drop and / or target during an inhalation operation using an inhaler. It includes an interactive system for measuring or monitoring real-time characteristic changes in these flows. Apparatus and / or devices and methods are disclosed. The devices, in conjunction with the inhaler, are used for the target respiratory operation. To maximize efficiency, it can be used to detect and monitor targets and therefore train them. Furthermore, appropriate dose delivery, timing of dose delivery, and appropriate use of the inhalation system during use. To detect performance, it can be used to monitor inhalation during drug delivery. (Example) In one specific embodiment, the sensing and monitoring device may be applied in conjunction with a high-resistance inhaler. In this embodiment, the detection and monitoring system is particularly used in conjunction with a dry powder inhaler. Many characteristic parameters of the inhalation operation can be measured using this method, and these characteristic parameters include the start of inhalation. The peak inhalation effort (PIP2) within 2 seconds, and the total inhalation effort (AU) in the first second of inhalation. C1) Data generated to evaluate total inhalation volume and duration of inhalation of patient inhalation effort. The handheld inhaler system includes two components: the inhaler and the inhaler accessories. It is explained that, however, a person skilled in the art can measure or monitor data and characteristics during the inhalation operation. The design of this system and method of the present invention also sacrifices flexibility and reusability. Nevertheless, it can be understood that this may apply to devices in which the auxiliary features are integrated into the inhaler itself.

[0045] The device is an inhaler adapted to be attached to or otherwise associated with an inhaler. The device includes an accessory. The device includes at least one transducer or sensor, This detects at least one measurement value, including pressure, airflow, air volume, humidity, and temperature, and These can be converted into electrical signals. In some embodiments, the sensor passes through the inhaler. It may include a Doppler sensing device capable of detecting the flow of air or gas. In other embodiments, The sensor includes a pressure sensor that can detect a pressure drop during the inhalation procedure. Inhalation device accessory. Furthermore, it performs appropriate signal tuning such as signal filtering, amplification, and analog-to-digital conversion. The circuit and the generated signal are simultaneously or in real time received by a computer or mobile device. For transferring to a terminal (PDA), such as a mobile phone for displaying signals or processed information. This includes processing circuits such as a microprocessor and wired or wireless communication interfaces. This may include an electronic board equipped with circuit elements. In some embodiments, an output display Since it can be an interactive display, the display device can be acquired by doctors and / or patients. This provides visual assistance, allowing you to see the configured inhalation operation parameters. The information obtained in this way is used to determine the target for performing repeatable inhalation operations in real time. It can serve as a guideline for this purpose, thereby enabling proper inhalation delivery of the drug during self-administration. To enable. In another exemplary embodiment, data can be stored so that it can be analyzed at a later date. .

[0046] Figures 1-7 show embodiments of a dry powder inhalation system or training device and its components. This indicates that the interactive training equipment systems described herein are subject to a U.S. license of 8,499. U.S. Patent No. 757, U.S. Patent No. 8,636,001 and U.S. Provisional Patent Application No. 62 / Compatible with high-resistance dry powder inhalers such as those disclosed in Patent No. 289,095. And with respect to all disclosures they make regarding dry powder inhalers, we refer to those disclosures. This is incorporated herein by reference.

[0047] Figures 1 and 2 show wireless and wired inhalation detection and monitoring systems 10 and 12, respectively. The system includes an air conduit 16 and an exhaust port 1 for delivering powder to the user / patient. Includes an inhalation device 14 including a mouthpiece 15 having 7. Inhalation detection and monitoring system 10, 12 also attaches to the inhaler 14, connects to it, or otherwise associates with it. Includes an inhalation device attachment 18 adapted to the following. In this embodiment, the inhalation device attachment is Includes an operating button 19 for turning the power of stems 10 and 12 ON / OFF. Air conduit, An air conduit path is established between one or more intake ports to establish an air conduit route through the system, At least one air conduit route is used to carry dry powder for delivery to the individual. It passes through the container in which it is contained. In some embodiments, the inhaler is used for the proper use of the inhaler. In relation to this, no powder is added at all during patient training. In the embodiments shown in Figures 1 and 2, Inhaler 14 is of the same type, and is a dry powder inhaler, and inhaler accessory 1 8 can be fitted to the top surface of the inhaler 14. Figure 2 shows the connection to the power supply and / or computer. The diagram shows an inhaler attachment 18 having an electric wire 22 connected to the system.

[0048] Figure 3 shows a top view of another embodiment of the inhaler attachment 24 designed to fit an inhaler. Figure 4 shows an isometric view of the side. Figure 4 shows an isometric view of the bottom side of the device 24. As shown in Figures 3 and 4... The accessory device 24 preferably has tabs 25, 25' for attachment to the inhaler. Including the main body. However, other types of fixed devices known to those skilled in the art may be used to connect the device with the inhaler. It can be used to combine. The device 24 can also preferably be started to use It includes an activation button 26 for doing so. In this embodiment, the body has a top surface 27 and a bottom surface 28, It has an electronic board 30 mounted on the bottom surface. Figure 4 shows that it is integrally incorporated into its lower surface 28. Figures 4 and 5 show an embodiment of an inhaler attachment device 24 having an electronic board 30. The electronic board 30 is shown. Preferably, the electronic board 30 is mechanically operated by the operating button 26. The actuator 26', sensor 29, and microprocessor are connected by other means. Includes a 32 microprocessor. The 32 microprocessor activates and detects signals from the associated inhaler. It provides processing and communication of information / signals to display devices. In this embodiment, electronic Board 30 is configured as a signal processing / interface board. Sensor 29 is Any type of sensor, for example, an acoustic sensor to detect sounds generated during inhalation. - Or it may be a pressure sensor for detecting a pressure drop during inhalation. Inhalation device accessory 24 also preferably as a power source to start the system when the activation button is pressed. , equipped with a battery. Those skilled in the art will recognize that the electronics included in the inhaler attachment 24 are, Provided as separate circuit components on separate boards connected by the appropriate means required for the function. Understand that this is possible. For example, the microprocessor 32 determines the arrangement of the sensor 29. Depending on the necessity, it may reside on a separate board from sensor 29.

[0049] In another embodiment, the inhalation detection and monitoring system is an indicator as shown in Figures 6 and 7. It is equipped with a device. Figure 6 shows the signal indicators 35 and 36, and the inhaler is attached as shown in Figure 1. An isometric view of the dry powder inhaler connected to the device is shown. Figure 7 shows the signal indicator 35 A dry powder inhaler connected to an inhaler attachment device 18, as shown in Figure 2, which shows 36. An isometric view is shown. Signal indicators 35 and 36 are preferably used to indicate to the user some kind of stay. A light-emitting diode or other light indicator used to indicate a signal. For example, a signal indicator. The DATA can be used to indicate whether the inhalation resulted in successful drug inhalation. For example, during operation, one indicator may show a red signal light, and another indicator may show a red signal light. The dicator can display a green signal light. Signal indicators 35 and 36 indicate disease Regarding the effective delivery of powder via inhaler for treatment, users should be informed of whether the device is unsuitable or unsuitable for use in treatment. The indicator will show accordingly. A failed inhalation indicator (red light) will indicate that the subject or patient who administered the medication has failed the inhalation. The inhalation procedure involves one or more predetermined steps related to the inhalation of the powder dose contained in the inhaler. This indicates that the standards were not met, and the passing inhalation indicator (green light) is not applicable. Alternatively, the patient's inhalation technique may be appropriate for delivering the appropriate dose of powder contained in the inhaler. To indicate that the condition is met. Or, if the color can be selected based on the status, or For example, if flashing may be used to indicate status, only one signal indicator may be used. It may be used. Signal indicators 35 and 36 are used to facilitate visual perception by the user. Furthermore, it can be positioned anywhere within the exterior.

[0050] In another embodiment, an LED signal is also integrated into the inhalation attachment and indicates the quality of the inhalation operation. It can be used for various purposes. For example, a continuous red light indicator can be used to inform the user that the inhalation has failed. This, and subsequent attempts, required a more thorough, deeper, or faster inhalation. It may indicate that there is a flashing red light indicator, The inhalation was unsuccessful, and subsequent inhalations need to be performed for a longer period. This can be indicated by a continuous green light indicator. In this embodiment and other embodiments, a continuous green light indicator This means that the inhalation was successful, or that the contents of the dry powder inhaler were delivered to the target during inhalation. This indicates that it was acceptable. Other uses of signal indicators 35 and 36 include power ON / OFF, power abnormality or low battery indicator, or connection status between the accessory device and the inhaler. It may include -s.

[0051] In an alternative embodiment, the inhalation detection and monitoring system reports the quality of the inhalation operation. The system includes an indicator that includes an ethometer. In this embodiment, the annanciator is optionally a separate It is designed to be activated at any time and is particularly suitable for users with visual impairments.

[0052] Figure 8 is an isometric view of an alternative embodiment of the wireless dry powder detection and sensing inhalation system 12. This shows that the inhalation device attachment 42 is attached to the inhalation device 14 and the patient performs the inhalation operation. The main body of the accessory device 42 is integrated so that it can be visualized simultaneously with the patient's inhalation effort. It is shown in configuration with the displayed screen 44. In this embodiment, The inhalation device attachment 42 includes an electronic board 30 as shown in Figures 4 and 5, where, The signal information related to the device is processed by the microprocessor 32, and as a result, The processed information is communicated to the display screen 44, and preferably, the inhalation device used. This is presented as a graph comparing the ingredients to one or more predetermined criteria. The graph and associated data points are preferably stored locally on the electronic board 30. Furthermore, it can be stored remotely. In this embodiment and other embodiments, for inhaler The predetermined criteria depend on the inhaler and medication being used. (See the drawings in this specification.) In that embodiment, the criteria used are, as described above, peak inhalation pressure, released dose, etc. That's right.

[0053] Figures 9, 10, and 11 illustrate various operations of the inhalation detection and monitoring system shown in Figures 1-8. The implementation configuration is shown. Figure 9 shows the overall implementation of the wireless detection and monitoring system 50 disclosed herein. A block diagram of the configuration is shown. In Figure 9, the system 50 consists of two components, an accessory 54 and The system includes a suction treatment system 56. In this embodiment, the suction device accessory 54 includes an electronic board. The electronic board includes two sensors 51, 52, a battery 53, and a microprocessor 7. It has 0, and a wireless communication device or transceiver 72. Analog sensor 51 and digital sensor The SA52 is positioned so as to be in close proximity to the inhalation device airflow conduit, and the inhalation detection and monitoring system When M10, 12 is activated or switched on, an audio signal or inhaler 14 is emitted. To enable detection of pressure differences. The system also needs a power source to supply power to the system, for example, a battery. Power is supplied by pressing the operation buttons 19 and 26 connected to the battery 53. The system can be powered by wires, such as a USB port. Sensors 51 and 52 are Preferably, at any point inside or near the air conduit of the inhalation device attachments 18, 24 They are arranged. In some exemplary embodiments, sensors 18 and 24 are located in the main body of the accessory device. It may be placed inside the 20 or in the air conduit near the mouthpiece 15 of the inhaler in use.

[0054] Processing system 56 is a PDA, tablet, mobile phone, or computer 57, display Playback device 58, wireless communication device 59, and digital storage, web interface, printing It may include an output unit 55 that can be in the form of a physical object or an email. The spray unit 58, wireless communication device 59, and output unit 55 are not separate elements, but simply PDA / T It should be understood that this can exist within a Bullet / mobile phone / computer 57. In an exemplary embodiment, the user presses the power button, for example, button 19 of the device 10. This activates the inhalation device attachment 54, which in turn activates the processing system 56. The computer 57 is preferably a software designed to collect and display the intake effort. Includes algorithms in the form of wearable applications or programs. Computer 5 When the software program integrated with 7 is started, the start signal appears on display 58. It appears there. With the system running, the user's inhalation 60 causes the inhalation training device 5 At 0, a pressure drop occurs, which is detected by one or more of the sensors 51 and 52. It is converted into an energy signal. In this embodiment, sensors 51 and 52 are analog or digital It can be a pressure, flow, sound, light, gas, humidity, or temperature transducer. The electrical signal generated from the sensor 51 is then transmitted to the signal regulator 61. Undesirable parts of the signal, such as signal noise, are removed. Then the adjusted electrical signal 62 The signal is then transmitted to the bandwidth limiter 63, so that the signal frequency is narrowed to the desired range and analyzed. The necessary data is reduced and selected, 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. Furthermore, it can be transmitted as an amplified signal 65. Subsequently, the amplified signal 65 is analog • Converted to a digital signal 67 by the digital converter 66. Those skilled in the art will know how to adjust, Some of the filtering, amplification, and conversion functions are incorporated into the sensor itself. It should be understood that various types of "smart" sensors may be used. Any reference to these subsequent elements in the details does not apply to the use of such integrated sensors. It can be replaced by that. Therefore, the digital signal 67 is transmitted by the microprocessor 70 The signal is received and transmitted to the wireless communication device or transceiver 72, and this wireless communication device or transceiver , having a wireless communication device 59 for receiving wireless (e.g., Bluetooth) signals 69 To transmit to the computer 57, wireless communication such as Bluetooth is performed via the connection unit 74. It is designed to transmit using technical standards. Microprocessor 70 or The software program built into / programmed into the Pewter 57 detects the presence of wireless To notify, to link to a wireless communication device or transceiver 59, and to transmit from element to element This facilitates the smooth operation of basic functions within the inhaler attachment, including the transmission of data via line signal 69. The program also converts electrical signals from sensors 1 and 2 into pressure values, which are then plotted on a graph. The display 58 may be an LED, OLED, LCD, or touchscreen. This may be a screen including a stylus screen or other interactive display. Several implementations In this configuration, a baseline curve for the user is stored in the system 50, and the inhalation signal The information is provided on display 58. The baseline curve is based on the user's inhalation operation. When measured using the inhalation training device 10 as a reference standard for instruction, the patient This indicates the level of performance of the inhaler type for delivering a substantially accurate dose. While inhaling, the user can visually compare their inhalation technique to a baseline standard. It is possible to omit the medication from the inhaler while training the user, so the medication It is not wasted due to a failed inhalation procedure. In this way, the user can be assured that the drug is actually inhaled. When this is done, the user's inhalation effort is changed to match the standard requirements. The data displayed for each inhalation performed is sent to the output unit 55 via the second connection unit 76. It can be stored, and here, the data can be properly stored or transferred. For example, The output unit 55 can take the form of a disk drive, a flash drive, or a printer. It may be located in, or, if necessary, to be considered or further trained, via email. Alternatively, it can be transmitted to a physician via text. In some embodiments, the inhalation training device or These signals can be transmitted to a computer / PDA / mobile / tablet, and the computer Signals from a data / PDA / mobile / tablet may be received by the inhalation training device. This establishes two-way communication between the two components. For example, user However, computer 57 receives certain information, such as patient number, dosage strength, and comments regarding the patient's condition. It can input values ​​such as . In this embodiment and other embodiments, the sensor 52 is digital A sensor is a sensor that can produce a digital output. Sensors include accelerometers and digital sensors. This may be a pulse sensor, light meter, or laser, and the detected signal is transmitted to a built-in microprocessor. It can be sent directly to the parser, where it can then be analyzed, processed, and transmitted. Microprocessor The signal information within the system is, for example, obtained using a graphical interface to collect data on pressure versus time. The data can be analyzed and processed using an algorithm that converts it into a curve, and this can then be displayed. The signal from sensor 52 can transmit information about flow, pressure difference, etc., and this information is transmitted to the sensor. -When both 51 and 52 are used, the signal will be different from the signal in sensor 51.

[0055] Furthermore, other onboard equipment 78 transmits data through one or more cables 79, and It can receive data from the microprocessor 70. For example, other devices equipped with it can receive data from digital Power output sensor, temperature sensor, light-emitting diode (LED), alarm sound device, and other mounted equipment. This may include sensors. These onboard devices may include LED light or audible indicators for pass / fail. The indicator may be used to output the pass / fail criteria for the inhalation operation. Temperature, humidity, or other environmental data may be used to determine the environment in which the inhaler was used. .

[0056] Regarding the output of sensor 51 following signal amplification, the amplified signal 65 is instead, It may be transmitted directly to the computer 57 via the wireless communication device 72, and the computer will, Log-to-digital conversion and other necessary analysis steps can be performed.

[0057] Figure 10 shows an implementation of the detection and monitoring system disclosed in Figure 8, equipped with an integrated display. A block diagram of the configuration is shown. The inhalation detection / sensing device 82 is an integrated display 84, micro Onboard electronic system with processor 86; analog sensor 88 and digital sensor -89, including inhalation device accessories. When in use, the system is activated by user 90 pressing the activation button 1. It is activated by pressing 9 and powered by battery 92. When inhaled using an inhaler compatible with the inhaler accessory device 82, including the onboard electronic system, One or more of the sensors 88 and 89 generate a signal, and this signal is processed by the microprocessor 86 It is transmitted to. For example, an acoustic sensor or microphone 88 generates an electrical signal 94. This electrical signal may be used to send to signal regulator 96 to remove excessive noise. The electrical signal is then transmitted to the band limiter 98 to limit the signal frequency to a desired range. The data that needs to be narrowed down and analyzed is reduced, and then the signal is sent to the signal amplifier 95. There, the signal is amplified and transmitted to the analog-to-digital converter 97, and then to the digital converter 97. The signal is communicated to the onboard microprocessor 86, which analyzes the information and converts it into a graph. The data is transmitted to the display 84 for visualization. -89 is used in place of or in conjunction with sensor 88 to detect a signal and It can generate a set of signals to send to the microprocessor 86, microprocessor Similarly, the signal is analyzed, stored, and transmitted to the display 82. Other devices, including the Surfing device, 99 are also included to detect other parameters of the inhaler or system. It is possible.

[0058] Figure 11 shows a visible performance indicator that shows the operational part of the system, rather than the integrated display. A block diagram of an embodiment of the detection and monitoring system 100 disclosed herein, which includes a data set, is shown. In this embodiment, there are two sensors, an analog sensor 101 and a digital sensor 102 is provided. When the system 100 is powered by battery 103, The patient / user 105 inhales, and the airflow moving through the inhalation device conduit generates signals such as sound. Sensors 101 and 102 are activated to establish a signal from the inhaler and to lower the signal. Sending into the flow; Sensor 102, for example, from airflow detection, analog or digital It can be used as a Doppler that can receive output signals that may be shifted. If the numbers are digital, they are microprocessors used to analyze and process the input information. It is transmitted directly to sensor 110. At the same time, sensor 101 generates electrical signals, and these electrical signals The air signal is detected within the inhaler and passes through the signal regulator 106 to remove excessive noise. Subsequently, the adjusted signal is sent to the bandwidth limiter 108 to select the data to be analyzed. Subsequently, the restricted signal is sent to the signal amplifier 109, where the signal is amplified, and The signal is sent to the analog-to-digital converter 112. The received signal is then converted to digital. It is converted into a signal and transmitted to the onboard microprocessor, where it is divided using an algorithm. The data is analyzed and processed, thereby converting it into, for example, visible or optical signals, and visible As an indicator, for example, a green or red light may be displayed to indicate that the patient's inhalation effort has passed. "Did it," that is, was it inhaled with adequate effort to deliver the dry powder dose? Alternatively, the patient's inhalation effort is insufficient to deliver the dry powder dose from the inhaler being examined. It can display whether it was. In this embodiment, other mounted equipment 115 is the sensor used. Depending on the type, the circuit may include other sensors, or signal regulators, amplifiers, and A / D converters. It can be integrated into a converter. For example, an inhaler accessory has two or more analog sensors. To obtain the signal, the electrical signal is sent to a microprocessor for information analysis and processing. It must pass through an A / D converter beforehand. In an alternative embodiment, a digital sensor is used. It can be used, and its output signal can communicate directly with microprocessors 86 and 110.

[0059] In other embodiments, the inhalation device accessory includes a temperature sensor, a laser beam, and a Doppler sensor. Light sensors, illuminance meters, color sensors, text recognition, RFID, optical character recognition, optical identification, It may have one or more sensors, including turn recognition, and its output signals may be, for example, If it is not a digital signal output, it can be an analog signal output, and once those signals are microphone Once it reaches the processor, it is converted into a digital signal for further analysis and processing. It is necessary. These sensors are preferably included in the inhaler attachment to determine which drug is being administered. Whether it is loaded into the inhaler for administration, and what cartridge type or such Identify whether the correct dosage of medication is loaded into the inhaler.

[0060] Figure 12 shows the tablet / computer / PDA / phone 57 of the processing system 56 in Figure 9. A screenshot is shown. Computer 57 is connected via Bluetooth or another remote Wireless technology is used to communicate remotely with the inhalation device attachment 54, where, The inhaler attachment 54 is fitted to the inhaler, and when the system is activated, the inhaler You are instructed to inhale through the mouthpiece. As shown in Figure 12, on the screen The resulting graph shows sensor (e.g., pressure) measurements and flow in seconds on the x-axis. Considering the time difference, the suction effort is plotted on the y-axis in response to the suction operation. The inhalation effort of the elephant is represented by curve A above the trapezoidal figure B at the bottom of the graph. The outer limit of trapezoid B (i.e., the upper part of the area) is the powder inside the inhaler when taking the medicine. The inhaler is used to dispense the contents, allowing for effective and consistent inhalation of the powder dose. This is interpreted as indicating a threshold or the minimum inhalation effort that the subject must make to achieve this. An identification sensor, such as those described herein, is located within the inhaler attachment. detects data relating to the inhaler, drug type, dosage, lot, expiration date, etc., and transmits such data. The data is processed to identify corresponding threshold data for display to a user. The trapezoid also indicates the minimum characteristic criteria exhibited by the inhaler, or the effort required for the inhaler to consistently deliver dry powder doses, with the delivery rate exceeding 90% for patients. Figure 12 graphically shows an exemplary display of an inhalation operation performed by a subject who is instructed to inhale deeply and can view the display screen on a tablet while performing the inhalation. As can be seen from such a curve, the subject performed entirely within the acceptable values in region A.

[0061] Furthermore, Figure 12 shows baseline standards for inhalation behavior related to the inhaler attachment device 10 and drug identification. The curve A detected by the user may be adjacent to a warning region immediately above region B, and an acceptable or preferred region C above the warning region. Regions B, C and the warning region are provided in different colors to help judge these regions when monitoring an individual's behavior during inhalation. Region B may, for example, be shown in red, indicating that the inhalation operation does not meet baseline requirements; therefore, the delivery system is not optimal for effectively delivering the drug. The warning region may be shown in yellow, indicating a warning that the inhalation operation is approaching an unacceptable level of inhalation effort. Preferred region C may be shown in green, indicating that the inhalation behavior is within the acceptable effort range for effectively delivering the drug. This display information detected from one or more sensors in the device is used by a clinician, doctor or user to inform the user whether proper dosing has been performed, or how much effort is required to ensure proper administration of the drug ​​​ It can be determined whether it can be used for training.

[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 an overall wireless detection and monitoring system as disclosed herein. A block diagram of an embodiment is shown. In Figure 13, the system 120 consists of two components, an intake. The system includes training equipment or auxiliary devices 124 and a processing system 126. The processing system 126 is , PDA, mobile phone or computer 127, display 128, wireless communication device 129 , and output units that can take the form of digital storage, web interfaces, printed materials, etc. 125 may be included. In this exemplary embodiment, the user controls the power button, for example, the training machine. By pressing button 19 on device 10, the processing system 126 is also activated. The inhalation training device or apparatus 120 can be activated. Software integrated into the computer 127 When the software program starts, a start signal appears on the display 128. In this configuration, the auxiliary device 120 is preferably positioned very close to the intake airflow conduit. Includes an electronic board having two pressure sensors 121 and 122, and a power supply, for example, similar Press the activation buttons 19 and 26, which are connected to battery 123 that supplies power to the system. When devices 10 and 12 are activated or switched on, the inhaler The differential pressure and the absolute pressure of the environment from the inhaler 14 are made detectable. In this state, a pressure drop occurs within the inhalation training device 120 due to the user's inhalation 130. This is measured by sensor 121. The absolute pressure sensor 122 is related to atmospheric conditions. The present invention provides data or signals used to correct differential pressure readings.

[0063] In this embodiment, sensors 121 and 122 are digital pressure sensors. Therefore, the signals generated by sensors 121 and 122 are processed by the microprocessor 13 It is transmitted to 1 and the wireless communication device 132. Microprocessor 131 or computer 1 The software program incorporated into / programmed in 27 controls the sensor 121 and The signal generated by 122 is converted into a (corrected) pressure value, which is then displayed. The graph may be displayed at 58; this display uses LED, OLED, LCD, or touchscreen. This may include a screen with a lean or other interactive display.

[0064] Figure 14 shows a block diagram of an embodiment of the detection and monitoring system disclosed herein. The input detection / sensing device includes an integrated or combined display 144 and a microprocessor 143. , and an inhaler including an onboard electronic system 140 equipped with pressure sensors 141 and 142 Includes auxiliary equipment. When in use, the system is operated by user 146 and battery 1 Power is supplied by 45. With the system running, the user's intake 146 Then, a pressure drop occurs in the inhalation training device 140, which is measured by the sensor 141. The absolute pressure sensor 142 is used to correct the differential pressure reading with respect to atmospheric conditions. To provide data or signals. In this embodiment, sensors 141 and 142 provide digital data. It is a barrel pressure sensor. When an analog sensor is implemented, additional circuit elements are added. This is necessary for adjusting, filtering, amplifying and / or converting signals as disclosed below. Therefore, the signals generated by pressure sensors 141 and 142 are sent to a micro processor 143. A software program incorporated / programmed into microprocessor 143 converts the signals generated by sensors 141 and 142 into (corrected) pressure values, which can be graphically displayed on display 144. This display may be a screen including an LED, OLED, LCD, touch screen, or other interactive display.

[0065] Figure 15 shows a block diagram of an embodiment of the detection and monitoring system disclosed herein. An inhalation detection and sensing device includes an inhaler accessory device that includes an on-board electronic system 150 comprising an integrated visual indicator 154, a microprocessor 153, and pressure sensors 151 and 152 In use, the system is activated by a user 156 and powered by a battery 155 With the system activated, the user's inhalation 156 generates a pressure drop within the inhaler training device 150, which is measured by sensor 151 . Absolute pressure sensor 152 provides data or signals used to correct differential pressure readings for atmospheric conditions. In this embodiment, sensors 151 and 152 are digital pressure sensors. If analog sensors are implemented, additional circuit elements will be required for signal conditioning, filtering, amplification and / or conversion as disclosed above. Therefore, the signals generated by pressure sensors 151 and 152 are transmitted to microprocessor 153 A software program incorporated / programmed into microprocessor 153 converts the signals generated by sensors 151 and 152 into (corr ​ Convert to a (corrected) pressure value, which can then be used to indicate accurate inhalation or other information. It can be used to activate the visible indicator 154.

[0066] Figure 16 shows, for example, various further operational components of an inhalation training device, e.g., an apparatus. Further block diagrams relating to 10 are shown. In Figure 16, system 160 consists of two components. , including inhalation training equipment or accessory device 164, and processing system 166. Processing system 1 66 is a tablet, PDA, mobile phone / smartphone, smartwatch, smart Glasses, or computer 167, display 168, wireless communication device 169, and digital Output unit 165 which may take the form of a digital storage, web interface, printed material, etc. This includes. In this exemplary embodiment, the user presses a power button, for example, on the training device 10. By pressing button 19, the processing system 160 is also activated, and inhaler training is performed. Device 160 can be started. The software program integrated into computer 167 opens. When started, a start signal appears on display 168. With the system running, The user's inhalation 170 causes a pressure drop within the inhalation training device 160, which is the sensor Measured by sensor 161. In this embodiment, sensors 161 and 162 are digital This is a barrel pressure sensor. Therefore, the color detection sensor 173 and the pressure sensor 161 and The signal generated by 162 is transmitted to the microprocessor 171 and the wireless communication device 172. It is sent to the microprocessor 171 or computer 167. The programmed software program includes color detection sensors 173 and 161. The signals generated by and 162 are converted into cartridge information values ​​and pressure values, respectively. This can be displayed as a graph on display 168, which uses LEDs and OLs. This may include screens such as EDs, LCDs, touchscreens, or other interactive displays. The cartridge information values ​​are used to provide limit values ​​regarding the effectiveness of the powder dosage. It can also be plotted as trapezoid B, or as other threshold representations on a graphic display (e.g.) For example, Figures 23, 24, 25, and 26). As mentioned in the embodiments described above, color In addition to detection equipment, other equipment on the device board may include lasers, RFID, patterns, or text. T / may include a character reading device or sensor, and in other ways in which inhalers, drugs, or substances / drugs Connected to a microprocessor to identify cartridges / packaging. These sensors / readers are used in the system and microprocessor to detect drugs, substances, To work towards providing data on packaging, medication, inhalers, etc., The data is retrieved from storage and includes any possible graphs displayed to the user. It can be used as a data point on a visual, audible, or other indicator. For example, certain types of The cartridge or other packaging may be color-coded, or encrypted or coded. RFID tags that display specific information about them, such as lot number, expiration date, and dosage. It may include a microprocessor capable of detecting and using the code for calculations. A reader or sensor capable of transmitting data identifies the action and data display. Perhaps certain colored packages require more effort to properly inhale. This indicates the use of the drug dosage. In this case, the attached equipment or system is a sensor / reader. This identifies the appropriate color and uses 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 input detection / sensing device 180 includes an integrated or combined display 184 and a microprocessor. 183, color detection sensor 187 and pressure sensors 181 (differential pressure) and 182 (absolute pressure) The inhaler accessory includes an onboard electronic system equipped with the following: When in use, the system is used by the user It is operated by 186 and powered by battery 185. The system starts When the device is in motion, a pressure drop occurs within the inhalation device attachment due to the user's inhalation 186. This is measured by sensor 181. The absolute pressure sensor 182 is related to atmospheric conditions. The present invention provides data or signals used to correct the differential pressure reading. Sensors 181 and 182 are digital pressure sensors. Therefore, color detection sensors The signals generated by 187 and pressure sensors 181 and 182 are processed by a microprocessor. It is sent to the microprocessor 183. It is programmed into the microprocessor 183. The software program includes a color detection sensor 187 and sensors 181 and 182. The signal generated is converted into cartridge information values ​​and (corrected) pressure values, This can be displayed as a graph on display 184, which is an LED, OLED display. This may include an LCD, touchscreen, or other interactive display screen.

[0068] Figure 18 shows a block diagram of an embodiment of the detection and monitoring system disclosed herein. The input detection / sensing device 190 includes an integrated visible indicator 194 and a microprocessor 193. It is equipped with a color detection sensor 197 and pressure sensors 191 (differential pressure) and 192 (absolute pressure). The system includes an inhalation device accessory, including an onboard electronic system. When in use, the system is controlled by user 196. It is operated by and powered by battery 195. The system is started In this state, the user's inhalation 196 causes a pressure drop within the inhalation device attachment, and this , measured by sensor 191. Absolute pressure sensor 192 measures the differential pressure with respect to atmospheric conditions. Provides data or signals used to correct the reading. In this embodiment, the sensor - 191 and 192 are digital pressure sensors. Therefore, color detection sensor 197 Furthermore, the signals generated by pressure sensors 191 and 192 are processed by a microprocessor. It is sent to 193. The built / programmed software in microprocessor 193 The software program generates from the color detection sensor 197 and sensors 191 and 192. The resulting signals are converted into cartridge information values ​​and (corrected) pressure values, respectively. This may be used to indicate a failed inhalation, an accurate / acceptable inhalation, or other information. This can be used to activate the visible indicator 194.

[0069] Figure 19 shows the system disclosed in Figure 16 for detecting, monitoring, and training on inhaled objects. A flowchart of an embodiment of Method 200 is shown. The user uses the device and system. When doing so, the user presses an actuator located on the inhaler attachment to activate the system. Activate the device and start it. Next, in step 202, the wireless communication of the inhaler attachment is performed. The device, for example, uses standard Bluetooth technology to connect to the user's smartphone. The link and the phone application will display a ready message and to the user The device is used to load the associated inhaler into which it is engaged, or to load the substance to be inhaled into the inhaler. Instruct them to provide a tamper-evident or other disposable package. After being inserted in that manner, the identification sensor, in this case the color detection sensor 173, is detected by the cartridge. Determine the color and store it in the data storage on the auxiliary device board, or B Send to processing system 166 (telephone) via Bluetooth and store. Step 2 In 06, the application receives the corresponding threshold data provided based on color detection. A graph of points is displayed. Then, in step 208, the user can... You will be instructed to inhale using visual, audible, or screen-based messages. In step 210, during the suction operation, sensors 161 and 162 detect a pressure drop. Then, step 212 is a correction step performed by the system based on atmospheric conditions. This indicates that this occurs substantially simultaneously with or immediately after step 210. In addition, the pressure data is stored as described above, and preferably in step 214, It is plotted on a graph. In step 216, the inhalation operation graph is plotted against the threshold graph. It is displayed to the user and indicates either a pass (successful inhalation) or a fail (failure to inhale). At that time, the user can press the actuator to terminate the program, and The data remains stored in the output unit 165 for future use.

[0070] In some exemplary embodiments disclosed herein, one or more key parameters are: Total inhalation time, peak inhalation pressure, time to peak inhalation pressure, and approximately 7 minutes from the peak of total inhalation time. Acceptable suction operations can be defined, including average pressures up to 5%. In some embodiments, The total inhalation time is from 0.1 seconds to 5 seconds, or from 0.1 to 3 seconds. Several embodiments Therefore, the inhalation time may exceed 5 seconds, and the peak inhalation differential pressure may exceed approximately 2 kPa, or 2 It can be ~6kPa. In some embodiments, the peak intake pressure is set to be above approximately 6kPa. The time to reach the peak inhalation pressure can be less than approximately 1.1 seconds, and the total inhalation pressure can be obtained from the peak inhalation differential pressure. The average pressure up to 75% of the time is approximately 4 kPa. These values ​​are from the inhalation monitoring system 10. , 12 and device 18, and training and monitoring inhalation with a high-resistance dry powder inhaler. These represent the values ​​of the associated algorithm / program used for that purpose, including resistors. It depends on the behavioral parameters required for optimal drug delivery via inhaler, and alternative inhaler training devices. It can be corrected in the container.

[0071] In another exemplary embodiment, the dry powder inhaler is used during the patient's inhalation procedure. Monitoring and / Alternatively, the device may be equipped with sensing and / or monitoring equipment capable of detecting. The dry powder inhaler is incorporated into the device. It may be equipped with a sensor device that is either embedded in or attached to it. In exemplary embodiments, the accessories 18 and 24 can be used as a mouthpiece or housing as desired. It may be provided as an integrated part of a dry powder inhaler located on the ring.

[0072] In an alternative embodiment, the inhaler attachments 18 and 24 are attachments that can be disengaged from the inhaler. It is a freely detachable sensing and monitoring device, and is provided in the form of an outer casing or cap. Here, the removable sensing and monitoring equipment is particularly suitable for wireless communication and dry powder absorption. It can be provided as a removable part that can be fitted into the device, so the target of the device user This makes it easier to access and move. In this embodiment, there is one or more exteriors. A microprocessor, wireless transceiver, A / D converter, capable of detecting and storing signals. onboard elements including sensors (such as pressure sensors or microphones) that can transmit or display information. It is manufactured as a separate, detachable device, including the electronics.

[0073] When using an acoustic sensor, inhaler with or without dry powder The sound waves generated are detected by a microphone, and the signal is analyzed and used. Depending on the type of sensor, when dry powder is present, air is released. This can be correlated with factors such as flow rate, the end of powder release during the inhalation process, and the temperature within the inhaler pathway. For example, an increase in sound is due to the flow rate through the equipment and / or the air stream being delivered. This may correlate with an increase in collisions of powder particles within the material.

[0074] Because of their small size, sensors such as microphones can be placed anywhere inside the inhaler. It may be placed. In embodiments where the sensor is a pressure transducer, the sensor is an inhaler. The sensor may be placed in an air conduit passing through one of the compartments. For example, it may be installed on or inside the air conduit of the inhaler, or it may be compatible with the inhaler. Caps and outer casings that are of a possible shape or form and that can be fitted to or attached to an inhaler. , as an accessory to an inhaler that may include a sleeve or saddle, a separate attachment It can be provided as a detachable part.

[0075] Regarding a removable embodiment, the sensing and monitoring accessory is easy and inexpensive to manufacture. Furthermore, it can be made from plastic and works well with high-resistance dry powder inhalers. In some embodiments, the sensor is any sensor, for example, a thermocouple wire, a pressure transistor Deducer, analog sensor, microphone, optical sensor, color sensor (spectrum) Includes electromagnetic radiation sensors, including light sensors, infrared sensors, and visible spectrum sensors. (m) a gas sensor, or any sensor capable of detecting a signal generated within the inhaler. The sensors described herein communicate or transmit signals using transmitting and receiving equipment. It may be adapted in such a way, or the signal may be sent to the microprocessor before this signal is sent. It can be transmitted or stored using a wired connection to an analog-to-digital converter.

[0076] Alternatively, an analog-to-digital converter may be provided inside the inhaler, and the resulting Digital data is transmitted directly from the instrument by the sensors described herein. The provided signal indicates powder particles mixed into the airflow and / or airflow path passing through the air conduit. Sound generated inside the inhaler due to the collision, and detection near the airflow path due to the inhalation operation. This can take several forms, including a pressure drop. It can be detected by a sensor and stored, transmitted, or displayed. Other types of signals that can be emitted are text, colors, cryptography, or codes, which is preferable. The light beam, laser beam, and Doppler sensor are incorporated into the electronic board. It can be detected by. The data can be generated from the signal and qualitatively and / or quantitatively. It is analyzed in this way, including dose release time, dose, dose type, administration time, etc. Measurements can be taken. Furthermore, these signals can be used to determine, for example, the patient, the type of drug and the dosage. May be associated with the identification of inhalers or other items, and may modify data requirements for proper inhalation. It can be used in rings and can facilitate training of inhaler users.

[0077] In one exemplary embodiment, a sensing and monitoring system for an inhaler is adapted to the inhaler. A structurally configured accessory; at least one sensor, microprocessor, Includes analog-to-digital converters and data storage media. The data storage media is a disc Drives, DVDs, CD-ROMs, servers, flash cards or drives, memory cards This includes codes and other components, and a microprocessor or other processing to execute the algorithm. It includes a set of machine-readable instructions that can be executed by the device. The algorithm is detected at runtime. Steps to generate a logical subsystem generation number from the signal; logical subsystem The stem generation number is stored in a data track within the logical subsystem, where the logical A step in which the subsystem generation number is compared with the cluster generation number within the processing equipment; and As a result of the input operation, the step of storing and / or displaying information from the algorithm is Start.

[0078] In an alternative embodiment, the dry powder inhaler is dry during the patient's inhalation procedure. Monitoring and / or monitoring signals generated by a powder inhaler or within a dry powder inhaler Alternatively, the device may be equipped with sensing and / or monitoring equipment capable of detecting. The dry powder inhaler is incorporated into the device. It may be equipped with a sensor device that is either embedded in or attached to it. The attached device is a dry powder inhaler located on the mouthpiece or housing, as requested. It may be provided as an integral part of the product.

[0079] In an alternative embodiment, the inhaler accessory is attachable / detachable from the inhaler. It is a removable sensing and monitoring device, and is in the form of an outer casing or cap, and here, Detachable sensing and monitoring equipment is suitable for dry powder inhalers, especially for wireless communication. Because it can be obtained and provided as a detachable part, the subject using the device can use it more easily. It is simply accessible and movable. In this embodiment, the exterior / inhalation device is 1 Detects signals such as one or more microprocessors, wireless transceivers, A / D converters, and color signals. An onboard engine for processing information, including a sensor that can store, transmit, or display signals. It is manufactured as a separate, detachable device, including the electronics.

[0080] Exemplary embodiments are shown in Figures 20-22. The inhalation detection and monitoring device is attached to the inhaler. It is compatible and has a proximal end 228 and a distal end 230, and includes an onboard electronic system. The system includes a detachable inhalation attachment 220, and the system is designed to be compatible with one another. The two components are an upper side member and a lower side member, and between the upper side member and the lower side member Circuit board containing electronic systems that are positioned and held together by fastening mechanisms such as screws. The main body 224 includes the upper side member, which includes the arm extensions 226 and 226'. The arm extension is separate from the mouthpiece and includes a fixing mechanism 223 for inhalation. It protrudes downward to fit snugly onto the distal end of the device. The circuit board connects the transceiver. Includes microprocessor; differential pressure gauge; absolute pressure gauge; and spatial arrangement of accessory assemblies in use It includes an accelerometer for determining localization. Figure 21 shows the lower surface and bottom side member of the main body 224. This includes a pressure equalization channel 234, which contains an absolute pressure sensor and a differential pressure sensor. It is configured between the sensor and the differential pressure sensor in use to equalize the pressure in the absolute pressure sensor and the differential pressure sensor in use. Therefore, it promotes air communication between the absolute pressure sensor and the differential pressure sensor. In one embodiment, The pressure sensor / differential pressure gauge is configured to be placed very close to the intake airflow path, The air passage of the inhaler and the absolute pressure sensor / absolute pressure gauge are configured anywhere on the device. In a preferred embodiment, the absolute pressure sensor is configured within the circuit board and the equalizing channel It communicates with the differential pressure sensor through channel 234. A significant discovery of this system is that absolute pressure When communication between the sensor and the differential pressure sensor is obstructed, the suction detection and monitoring device will not function. The main body 224 is also configured with an opening 236 on its lower surface. And, if the activation button 225 malfunctions, the reset button is used to re-power the system. I've made it accessible.

[0081] The main unit 224 also supplies power to the system 220 or switches it off. 225; Sys USB port for recharging the Tem220 or downloading stored information 232; LE for displaying light signals such as red (fail) or green (pass) signals. D-light quality signal indicator 227; displays the status of the power / charging connector. A system status indicator 229 is configured to be located adjacent to the activation button 225. Includes. In specific embodiments, depending on the complexity of the system, at least two emitters A sensor comprising at least two receivers may be used.

[0082] In this embodiment and other embodiments, during use, the inhaler accessory 220 including the accelerometer When the accessory device 220 is attached to the inhaler, the spatial localization of the inhaler can be detected. For example, Figure 22 shows an inhalation device including a wireless inhaler accessory 220 and an inhaler 242 adapted to it. The output / monitoring system 240 is shown. In this embodiment, when the system is activated, the inhaler Using an application that can inform the user of the correct positioning of the inhaler, It can be displayed on the screen of a mobile phone, tablet, etc. The inhaler contains a single dose of medication. If used in the wrong position before the inhalation procedure to deliver the substance, the device 220 will be incorrect. The display shows either the wrong orientation / failure (red) or the correct / appropriate orientation (green / white). It would be possible if the device is not connected to a PDA, computer, mobile phone, etc. In some cases, depending on the positioning of the user's device, haptic feedback signals or visual signals are used. Generated from device 220, it determines whether the device in use is oriented correctly or incorrectly. It can indicate whether the condition is good or bad. In yet another embodiment, inhalation detection... The monitoring enclosure contains one or more microprocessors, wireless transceivers, A / D converters, and signals. Includes onboard electronics including sensors that can output, store, transmit, or display signals. , it is manufactured as a separate, detachable device. In this embodiment, the software app The application (app) is wireless, not on a desktop or laptop computer. It can be used with devices such as smartphones and / or tablets. This app is for inhalation It can provide a graphical interface that displays a 3D model of the device. Dell may provide feedback regarding the spatial localization of inhalers. For example, if the user If the user holds the inhaler at the wrong angle during inhalation, the 3D inhalation will be displayed on the screen. By changing the color of the instrument model, a warning about inappropriate use can be raised, for example. The 3D model may appear in red. Improper use of inhalers can lead to problems with the powder content during administration. This can result in losses. Instead, the phone's voice / display app can detect incorrect direction of the inhaler. By visually or audibly alerting the user, the system can detect improper positioning of the inhaler. To indicate the eye.

[0083] In another embodiment, the inhalation attachment detects a plurality of individual wavelengths and individual wavelength measuring channels Includes a color sensor including a channel. The color sensor detects, for example, the color of the capsule or the color of the channel being used. Cartridge identification information (identity) based on powder dosage, inside the cartridge It can identify the amount of powder and provide a high-quality release of powder within the inhaler. The system uses LED light, audible / notifications to the user, or haptic feedback such as vibration. These parameters can be brought to the user's attention. In one embodiment, a spectral sensor — is used, and here the sensor determines the specific color of the cartridge or capsule. Therefore, individual or continuous wavelengths that can be algorithmically manipulated can be detected. The spectral sensor is used to determine which color cartridge is in use, and the cart It is possible to determine if the dosage strength of the contents of the ridge is equal. The dosage information of the cartridge , in order to confirm the dosage, the user may be informed or transmitted, or data may be transmitted. However, the data can be stored in the device for later use and comparison. Furthermore, the data is used for color detection. To further improve its accuracy, it can be analyzed using artificial intelligence algorithms.

[0084] In certain embodiments, the inhalation device attachment is visible light, infrared transmission (IR), and / or Includes an optical sensor capable of measuring ambient light signals, including ultraviolet (UV) energy. The number determines information regarding the use of the cartridge and the flow of powder through the inhaler. It can be used for this purpose. In one embodiment, the device emits from an inhaler or multiple parts of an inhaler. The ambient light being emitted, or the flashing light generated by the attached equipment, is emitted by a secondary light source. It is equipped to detect when it is amplified. In this embodiment, an inhaler or The signals generated from multiple parts of the inhaler are amplified to improve the precise detection of the light signal. The signal generated by the inhaler under ambient or enhanced conditions may indicate a specific activator or drug. When color-coded to indicate dosage, the cartridge or cap contains one dose. This describes the characteristics of the inhaler, including the cell portion. In one embodiment, the inhaler accessory is Includes means for generating light, including light-emitting diodes (LEDs).

[0085] In one embodiment, the inhalation device attachment is activated by a pressure sensor when the user begins an inhalation effort. This embodiment includes an automated collection system that detects the start of an inhalation operation, such as by measuring the start of an inhalation operation. The pressure sensor is configured to detect a pressure difference at a predetermined value, and the system The entire system is started to operate automatically. In some embodiments, the signal is automatically The collection system can also be automatically switched off after a certain period of time, which can be pre-set on the device. In this embodiment, the data to be captured is the entire process of the cartridge's inhalation operation and detection during use. This includes. In one embodiment, the inhalation effort produced by the object is such that when a minimum threshold is reached, It is measured dynamically.

[0086] In another embodiment, the inhalation device attachment is used for inhalation operation and cartridge dispensing or utilization parameters Data regarding the inhaler and cartridge in use, including the flow characteristics of the tad and powder. Since it includes a system for storing and transmitting information, the information is the target usage pattern and / or to allow for analysis to optimize treatment compliance of the medication plan. In this embodiment, the inhalation device accessory monitors the consistency of the subject's use and the delivery of the therapeutic dose. In one embodiment, the data acquired by the device is stored in the device and also in a digital application. The data may be sent to a communication center where the patient's optimal therapeutic effect can be analyzed.

[0087] In yet another embodiment, such as a Doppler ultrasonic sensor or a "time of flight" sensor, The sensor can be used to measure the amount of powder released. A Doppler sensor is, It is possible to detect ultrasonic diffraction signals from the powder flow from an inhaler in use. The number indicates the amount of powder released from the inhaler during inhalation and / or the quality of the inhalation operation (by the user). This can provide feedback from the amount of powder that should be inhaled, which can help the user. LED lighting, haptic feedback (e.g., vibration), or audible / notification feedback Therefore, it may be provided. For example, an LED on the exterior or tablet may be a continuous red light. The LED can be illuminated to alert the user to inhale more firmly, or The red LED can flash to alert the user to inhale for a longer period of time, or it can be turned off. A seamless green LED can alert the user to the correct inhalation. Another example is the exterior or This involves using haptic feedback on a tablet, where vibrations are used to communicate. The user is instructed to inhale more firmly, or by vibrating a few times, The device should be reminded to inhale for a longer duration, or the absence of vibration should indicate correct inhalation. In another example, the device is designed to specifically assist visually impaired individuals when administering powder to the user. The quality of inhalation can be communicated.

[0088] Instruct patients on the proper use of inhalers to deliver an effective amount of powdered medication through inhalation. When practicing, Figures 23-24 show the inhalation detection and monitoring device before standalone use, as shown in Figures 20-22. This shows an example of inhalation procedures performed by an inexperienced person. For training purposes, powder medication dosage is not wasted. To prevent this, an empty cartridge or placebo powder may be used. The screenshot shows the inhalation detection and monitoring device 22 via Bluetooth transceiver. Interactively linked to 0, where the inhalation effort by the subject is used as a time indicator in seconds. A standard baseline curve (blank area) is displayed to measure (Figure 23).

[0089] Figure 23 shows the mobile phone display when device 220 is operating and the mobile phone is also activated. These are screenshots of gameplay, and screenshots of the mobile phone are from before the inhalation, and the curve. The area above line A passes, and the area below curve A fails in the graphical user interface. The face is shown. The area above curve A is data obtained from multiple measurements from the inhaler. From this, it has been determined as the standard baseline, which is graphically represented by a single inhalation. This indicates the inhaler threshold parameter for effectively delivering the powder content contained within. When inhaled and the threshold parameter is reached, the area below A is shown by the diagonal lines in Figure 24. (Color may also be used), the user's inhalation is appropriate as it generates curve B above the standard curve. Therefore, the user's inhalation effectively delivers the single dose of powder contained in the inhaler. To indicate that it is acceptable to do so.

[0090] Figures 25 and 26 illustrate two different scenarios when patient inhalation is performed improperly. Figure 25 is a screenshot of the resulting user inhalation and the user's efforts. Because the force fell within the standard curve, the inhalation for delivering a single dose of powder was successful. This indicates that it did not go as planned. The displayed standard curve is shown in visible dark / red, indicating failure. This indicates inhalation. In this scenario, the user inhaled for the prescribed period, but the intensity of the effort was weak. When training this target, the user reaches a graphic similar to that shown in Figure 24. Until then, the user is instructed to inhale more firmly or with more effort. Figure 2 6 indicates a failed inhalation effort by the user that was not sustained for an appropriate period of time. It's a clean shot. In this scenario, the user's inhalation was initially appropriate, The user was unable to maintain the inhalation effort for the time required for proper use of the inhaler. Therefore, in this case, the user will not be able to receive the total amount of medication. The user exceeded the threshold parameter of the inhaler, and the curve was similar to that shown in Figure 24. You are instructed to maintain the initial strong inhalation effort for a longer period of time until it can be generated. In this way, the user of the inhaler uses the user's inhaler without assistance and takes the medication by themselves. They can be properly trained to do so.

[0091] Figures 27 and 28 show the operating steps of an embodiment of an inhalation detection and monitoring device in use. This is a low chart. Figure 27 shows an inhaler for use with a dry powder inhaler. For example, the AFREZZA® inhaler (MannKind Corp.) is a product that can be used. It is compatible with a removable detection and monitoring device. As shown in Figure 27, at the start of training, inhalation detection The monitoring equipment is assembled to the inhaler as shown in Figure 22. All equipment is step At step 250, power is supplied. Patient's food intake or patient's blood glucose level at step 253. Depending on the situation, in step 252, the appropriate dosage of the cartridge is 4 units, 8 units, Select from 12 units or 16 units, and in step 254, open the inhaler and turn The cartridge is installed in the inhaler by inserting it into the cartridge mounting area. Once the appropriate dosage cartridge has been inserted into the inhaler, in step 256 the inhaler It is closed. A sensor, which may include an optical sensor or a color sensor, is triggered, and the inhaler The system detects the identification information of the cartridge located within the cartridge mounting area, and stores the data. The data is then sent to the microprocessor. Once the cartridge is detected in the inhaler, If selected, the orientation (258) and the position of the inhaler are analyzed before inhalation. (Smartphone / ) The signal received by the tablet is indicated by an acceptable color selected for appropriate spatial localization. The 3D model of the device is displayed on the wireless device screen, and this display is shown in 260, An app that displays a graphical interface is used. In 262, the inhaler is inhaled If the inhaler is in the correct / appropriate special orientation for insertion, the selected color for the 3D display of the inhaler The same must remain in 269. In 261, improper rotation and pitch of the inhaler As a result, if the inhaler is in the wrong / inappropriate position for inhalation, the 3D image of the inhaler will For example, a different indicator of failure than the one selected for the inhaler in the correct position. 264 turns red. When the position of the inhaler is corrected in step 266, the inhaler The 3D model changes to the selected color. When you start inhaling, the pressure sensor is triggered. , and the quality of inhalation is evaluated by the processing system 270.272, inside the device The processing system calculates and displays a signal corresponding to the quality of the inhalation operation. Inhalation detection and monitoring device The device (outer casing) displays a visible signal from its quality LED signal display, and this display is 274. Incorrect / improper inhalation efforts performed in 273 will result in an uninterrupted red LED ( In step 276, the inhalation was weak, so in subsequent inhalations, it was necessary to be more thorough. (Inform the user that it needs to be done strongly), or the duration of the inhalation performed is too short. Incorrect / improper inhalation efforts resulting from this will cause a flashing red LED (this is 27 In step 8, the user is instructed that subsequent inhalation efforts may require a longer duration to achieve proper inhalation. (to indicate that) any of the above, and in step 279, a single dose of dry powder A seamless green LED light display that meets all the standards required for delivery to the target audience. That is the case.

[0092] In a further embodiment for use in conjunction with diabetes treatment, the blood glucose meter is removable Inhalation detection and monitoring device / outer casing may be incorporated, and here the outer casing is a smart blood glucose meter. Blood glucose levels are measured using a test strip and blood sample to determine the target blood glucose level and to create a treatment plan. This allows for minimizing the number of devices that need to be used depending on the target. Smart blood glucose strips are The wireless transceiver in the inhalation detection and monitoring device communicates with the device to calculate information obtained from the blood sample. In order to determine the appropriate dose required by the patient to lower the patient's blood glucose level, Standing up can help determine blood sugar levels.

[0093] In an alternative embodiment of use shown in Figure 28, the subject is trained to use the inhaler. Steps 280-298 are similar to or the same as steps 250-274. The devices are constructed and programmed using different communication codes and visual display signals. In this embodiment, the inhalation detection and monitoring device may be displayed only on the device or on a mobile phone or It includes an alternative device-specific device-visible signal that can be linked to a tablet. After performing steps 280-296, in step 297, the inhalation parameter is the inhalation parameter The quality was evaluated, and subsequently, the processing program assessed the quality of the inhalation at 298. The corresponding signal is calculated and displayed. In step 299, smartphone / tablet Let's graphical interface displays a graph of acceptable inhalation levels. A red graphical indicator without a corresponding red color indicates inaccurate / improper inhalation operation / effort, and The user should demonstrate appropriate inhalation effort with respect to the administration of dry powder during subsequent inhalations. Inhale more firmly until the green graphical indicator without eyes is displayed. Step 300 is instructed to perform the following: In the graphical interface... If the indicator displays red and green graphs, the intake effort is incorrect / inappropriate. Therefore, it is necessary to achieve a seamless green graph display, allowing users to inhale for longer periods. The user is instructed to do so. Once the user tries several times, the seamless green graphics appear. Once the interface is achieved, the user will be properly trained and able to use the inhaler. The power to the removable detection / sensing device is turned off, and the user is ready to begin the medication plan. They can be trained and sent home.

[0094] In certain embodiments, the inhalation device accessory includes, in particular, a unit dose cartridge and, for example, a Ketopiperazines, particularly fumaryldiketopiperazine, and active ingredients, such as peptides and Proteins, such as endocrine hormones including parathyroid hormone, insulin, and oxygen Tomodulin and glucagon-like peptide 1; symlin, i.e., Plumli Cannabinoids, nicotine, neurotransmitters, e.g., 5-hydroxytrip acid Vitamins, dopaminergics, prostacyclins, opioids This is useful for dry powder inhalers, which are equipped with a drug delivery formulation containing an agonist and an antagonist. In some embodiments, the active ingredient in the formulation is, but is not limited to, salmetero Epinephrine, tacrolimus, vancomycin, linezolid, filgastrin, Fentanyl, cannabinoids, such as cannabidiol and tetrahydrocannabinol (THC), or derivatives thereof; palonosetron, amphotericin B, phosphodiester Therase inhibitors, such as PDE5 inhibitors, such as sildenafil, avanafil, and bellolamine. Denafil (verdenafil) and tadalafil; prostaglandins, prosta Cyclins, for example, treprostinil, neurotransmitter agonists, neurotransmitter antagonists, for example Antinociceptive agents, opioid analgesics, For example, δ-opioid agonists and antagonists, κ-opioid receptor agonists and antagonists, μ-opio Dopamine receptor agonists and antagonists, nicotine, norepinephrine, dopamine reuptake inhibitors (NDRIs) and nicotinic receptor antagonists, nicotinic acetylcholine receptor agonists, Renicline, cyticine, bupropion, their derivatives, and their pharmaceutically acceptable salts It contains one or more activators, including, or combinations thereof.

[0095] An inhalation device accessory is provided, and the inhalation device accessory is: attached to or connected to the inhaler. A main unit configured to include; a microprocessor and at least two pressure sensors, A first pressure sensor for detecting information about the surrounding environmental conditions of the inhaler; and when in use a second pressure sensor for detecting a signal generated from the inhaler, and the first pressure The system includes a pressure equalization channel between the force sensor and the second pressure sensor, and the first pressure The sensor and the second pressure sensor each generate at least one signal, and The code is processed in the aforementioned microprocessor and customized by the microprocessor The sesser output is generated, and the microprocessor output is generated simultaneously with the user's inhalation or Immediately afterward, a pressure difference versus time curve is generated on the display. The inhalation device attachment is the first pressure The force sensor and the second pressure sensor are digital sensors, and their outputs are digital It is characterized by its barrel shape.

[0096] The inhalation device further includes a second pressure sensor which is an analog sensor, and The output is in analog format, and the device further adjusts and filters the sensor signal. It is characterized by including additional circuitry for amplification and / or conversion to a digital format. obtain.

[0097] The second pressure sensor detects a pressure drop measured in the flow path of the suction device, Furthermore, the above-described inhalation device accessory wherein the second pressure sensor detects atmospheric pressure. .

[0098] Furthermore, visible light or enhanced optical signals emitted from the inhaler during use under ambient conditions An inhaler attachment device as described above, including a light sensor for detection. In this embodiment, with The device further includes a light-emitting diode.

[0099] Furthermore, the characteristics of multiple parts of the inhaler, the inhaler cartridge, or other drug packaging Laser beams, Doppler sensors, and infrared sensors configured to detect files. - Or an inhalation device accessory as described above, including another sensing beam. In one embodiment, the accessory Inhalers for use with the inhaler include dry powder inhalers. In some embodiments, The inhalation device attachment described above includes a cartridge and a dry powder formulation. The dry powder formulation includes a powder inhaler and contains diketopiperazine and at least Contains one active ingredient.

[0100] The differential pressure sensor detects the pressure drop measured in the suction device, and the absolute pressure sensor The sensor, if necessary, adjusts with respect to atmospheric conditions before identifying a pressure drop. , an inhalation device attachment as described above, used in conjunction with a differential pressure sensor.

[0101] Furthermore: It can sense the color of the inhaler cartridge or other medication packaging loaded into the inhaler. Color detection sensors, RFIs in cartridges installed in inhalers, or other drug packages RFID reader for reading D tags, and inhaler or inhaler cartridge or Image detection that can identify characters, codes, or text information provided on other drug packaging. An inhaler attachment, such as those described above, including one or more sensors.

[0102] Furthermore, data received from at least two sensors is sent to a remote processing system. Includes a wireless transceiver and electronic board, as well as a microprocessor, sensors And the wireless transceiver is connected to and / or placed on the electronic board, as described above. An inhalation device accessory such as a visible indicator. In one embodiment, the inhalation device accessory further includes a visible indicator. The user achieved / performed with ideal or predetermined intake parameters. Includes a display for showing the difference between the inhalation operation and the operation. In some embodiments, The inhaler attachment has a visible indicator for the user indicating pass / fail, namely green. It is characterized by having a color / red indicator. In some embodiments, the inhalation row If the objective is successfully achieved, other communication modes to the user may be available, for example, remote It can be used in the form of a graph or other display format within the mart device.

[0103] A dry powder inhaler monitoring and detection system is also provided, and this system is: dry powder - Inhaler; microprocessor, wireless transceiver, and pressure in an area or part of the inhaler A first sensor for detecting difference information; and for detecting signals generated from the inhaler during use. Furthermore, it includes a second pressure sensor that communicates with the first sensor via a pressure equalization channel; The first and second pressure sensors each generate at least one signal, and the signals are: Processed by the aforementioned microprocessor, customized microprocessor -This becomes an output, and the microprocessor output is the inhalation operation performed by the user. The pressure-time curve characteristics are displayed graphically using a predetermined profile for each inhaler type. It is generated by comparing it with a graph of the value. The dry powder inhaler monitoring and detection system is Furthermore, the system includes a display, a wireless transceiver, and a threshold corresponding to the detected first sensor information. The display includes, and also shows user inhalation data corresponding to the second sensor signal. A microprocessor configured to report pass or fail status in a graphical format. - May include remote processing systems.

[0104] In one embodiment, the dry powder inhaler monitoring and detection system is further attached to the inhaler. A main unit that either does or is connected thereto, comprising a microprocessor, a wireless transceiver, and a se Includes a removable inhalation device attachment, including the main body in which the sensor is located.

[0105] It also provides a way to monitor and detect accurate data that can be used to train inhaler users. This method involves: displaying instructions for loading medication onto the inhaler; and providing information about the medication or inhaler. Reading data and associating the data with the corresponding threshold; starting the inhalation operation Displaying an indication; identifying pressure difference data between inhalations by the user; meeting a threshold. Whether the user passes the inhalation procedure, whether they exceed or exceed the threshold, or fail to reach the threshold. This includes determining whether it passed or failed. In one embodiment, the method further includes: A system that transmits and displays instructions indicating whether the user has successfully or unsuccessfully completed the inhalation procedure. The steps, including sending and displaying the link, are performed on a smartphone, tablet, or computer. This includes displaying on a processing system such as a radio or other wireless communication device; and transmitting Furthermore, the step of displaying the drug data and pressure difference data is transmitted wirelessly to the processing system. To transmit, and in the system, the pressure-time curve, along with a threshold corresponding to the drug data. , including displaying. In some embodiments, the corresponding threshold is set to remove background noise. This is a predetermined value set for the later inhaler type. [Examples]

[0106] Example 1 Use of integrated training equipment A 60-year-old patient with type 1 diabetes had elevated hemoglobin A1c levels and was considered uncontrolled. Therefore, for dietary therapy, inhaled insulin is provided from a dry powder inhalation system. The patient is instructed to administer insulin. The patient will use an insulin pump for basal insulin. The patient is equipped with a removable inhalation attachment as shown in Figures 3-5, as shown in Figure 1. The patient will be trained in wireless inhalation using the device. The patient will be given the device and training equipment. When using the device (whether or not it contains medicine), you are asked to breathe deeply and quickly. It can be seen.

[0107] The pressure sensor of the inhalation device is used to detect a pressure drop during inhalation, and the data is relevant. It is transmitted to a Bluetooth-enabled tablet with the application installed. The sensor detects the color of the cartridge (filled or empty) and uses the data to... The system identifies a threshold region for the minimum suction pressure. The data is obtained by reading radio signals from the device. Collected on a tablet with a programmed application that can be taken, The patient can view the data in real time on the display screen. The first attempt at inhalation was too slow, resulting in the red "unacceptable area" shown on the screen in Figure 12. The patient is instructed to enter area B. This is slightly faster and deeper than the previous attempt. Once the inhalation is complete, the graph shows the patient The inhalation operation is acceptable, and overall, it falls within the acceptable region (region C) of the graph in Figure 12. This indicates that the patient was present. With training, the patient will be able to use a similar inhaler loaded with medication. It will bear fruit.

[0108] The patient uses a dry powder inhaler similar to the type shown in Figure 1, and the patient's diabetes treatment You will be prescribed cartridges filled with various doses of inhalable insulin. Six months after being prescribed insulin, the patient's diabetes was diagnosed as being under control.

[0109] Example 2 Use of easily attachable / detachable training equipment: A 59-year-old patient with type 2 diabetes is administered inhaled insulin via a dry powder inhalation system. The patient was instructed to do so. The patient requested an inhalation system for convenience. The patient is shown in Figure 1. Patients will be trained in wireless inhalation using devices similar to those shown in Figures 3-5. When using the training equipment, provided with the device shown in Figure 1, which is equipped with an attachable inhalation device, They are asked to take deep, rapid breaths. Examples of inhalation techniques performed by different subjects are shown in Figure As shown in Figures 23, 24, 25, and 26, and as described above.

[0110] Pressure and color identification data are collected via mobile phone, and the patient can view the data on the display screen. The data can be viewed in real time. The patient's initial attempt was a result of the software. As shown in the graphs or other visually displayed threshold vs. inhalation data, It is tolerable. With training and familiarity, patients will be able to use the equipment reliably.

[0111] The patient-attachable sensor is removed from the dry powder inhaler. The patient, Dry powder inhaler, and filled with inhalable insulin for the treatment of diabetes in patients. A cartridge is provided. Six months after being prescribed inhaled insulin, the patient's diabetes is The patient was diagnosed as being under control, and commented that the device was very easy to use. .

[0112] The above disclosures are illustrative embodiments. Those skilled in the art will understand the technology disclosed herein. It is important to understand that this disclosure will reveal representative technologies that work well in implementing this disclosure. However, as those skilled in the art will see, many changes in light of this disclosure are specific to the disclosed This may be done in embodiments, but without departing from the spirit and scope of this disclosure, similar or equivalent methods may be used. It should be understood that this result will be obtained.

[0113] Unless otherwise noted, the quantities, characteristics, and examples of the components used in this specification and the claims are not specified. For example, all numerical values ​​representing molecular weight, reaction conditions, etc., are modified in all cases with the term "approximately". It is understood that this is the case. Therefore, unless otherwise pointed out, this specification and its appendices The numerical parameters described in the attached claims are the desired parameters that we strive to obtain. It is an approximation that can vary depending on the sex. At least, and the concept of the equivalent in the claims. This is not intended to limit the application examples, but each numerical parameter is at least reported. Considering the number of significant digits and by applying the usual rounding techniques, It should be done. The numerical ranges and parameters described in the broader scope of the embodiments of disclosure are approximations. Nevertheless, the figures explained in specific examples are reported as accurately as possible. However, all of these values ​​are inevitably derived from the standard deviations observed in each of those test measurements. It inherently contains a certain kind of error that occurs.

[0114] Use as used in the context of describing embodiments of the disclosure (in particular, in the context of the claims below) The words "a," "an," "the," and similar referents are used unless otherwise noted herein. Or, unless it is clearly contradictory in context, it is considered to cover both singular and plural forms. It is done. References to ranges of values ​​in this specification simply refer to each individual value that falls within that range. This shall serve as a concise method for individual references. Unless otherwise noted herein, Each of these separate values ​​is not combined in this specification as if they were listed individually. All methods described herein are included unless otherwise noted herein. Or, unless otherwise clearly contradictory by the context, they may be performed in any preferred order. Obtain. Any and all examples or exemplary language provided herein (e.g., "etc.") The use of "for example (such as)" simply makes the embodiments of the disclosure clearer. This specification does not limit the scope of the claimed embodiments in any other way. The language of this document indicates any non-patentable elements essential to the implementation of the disclosed and considered embodiments. It should not be considered as such.

[0115] Certain embodiments disclosed herein consist of and are essentially derived from language. The claims may be further limited by using the term used in the claims. At that time, regardless of whether it is as applied for or added by amendment, conversion words such as "consist of" This excludes any elements, steps, or components not specified in the claims. The transformation phrase "to essentially become from" refers to a specific material or step, and a basic and novel characteristic. The scope of the patent claims is limited to those that do not have a material effect on the subject. The embodiments described herein are essentially or expressly explained and enabled.

[0116] The grouping of alternative elements or embodiments disclosed herein is not limited to these. Not applicable. Each group member may individually, or with other members of the group or this statement. In any combination with other elements found in the book, it may be mentioned and claimed. For reasons of sex and / or patentability, one or more members of the group may not be included in the group. It is understood that any such inclusion or deletion may be performed. When this is done, this specification is deemed to include groups such as those that have been modified in this way. Therefore, all Markush Group specifications used in the attached claims satisfy Help.

[0117] Some embodiments are disclosed and considered by the authors of this disclosure in order to carry out the embodiments described herein. This specification includes the best known embodiments. Naturally, reading the above description is recommended. Modifications of these described embodiments will be apparent to those skilled in the art. The authors, A person skilled in the art would expect to use such modifications appropriately, and the authors have disclosed and considered these modifications. The embodiments described herein are intended to be carried out in a manner different from those specifically described herein. The diagram illustrates this. Accordingly, the embodiments disclosed and considered herein are as permitted by applicable law. This includes all modifications and equivalents of the subject matter enumerated in the attached claims. Furthermore, it may include: Any combination of the above elements in all variations is not otherwise noted herein. To the extent that or otherwise it is clearly inconsistent with the context, this is included in the disclosure.

[0118] Furthermore, patents and publications have been referenced numerous times throughout this specification. See the above-mentioned references and Each publication is incorporated herein by reference in its entirety.

[0119] In conclusion, the embodiments disclosed and considered herein illustrate the principles of the inventions that have been conceived. It should be understood that this is for illustrative purposes only. Other possible modifications are within the scope of this disclosure. There are alternative forms, though not limited to them, as examples of the teachings herein. It may be used in accordance with the above. Accordingly, the embodiments of the disclosure are accurate to those shown and described. It is not limited to that.

Claims

1. A main body configured to be attached to or connected to an inhaler, wherein the inhaler is a dry powder inhaler that enables inhalation; Microprocessor and A display capable of showing instructions for attaching the medication and instructions for starting the inhalation procedure, A first pressure sensor for detecting information regarding the environmental conditions surrounding the inhaler; and a second pressure sensor for detecting a pressure drop in the flow path of the inhaler during use. The pressure equalization channel between the first pressure sensor and the second pressure sensor and An inhalation device accessory, including, The first pressure sensor and the second pressure sensor each generate at least one signal, each signal is processed by the microprocessor, the microprocessor generates a pressure difference versus time curve as an output, and the output is displayed on the display. The microprocessor is an accessory to the inhaler that determines whether the user of the inhaler has succeeded or failed in the inhalation operation.

2. The dry powder inhaler has a resistance value of approximately 0.065 (√kPa) / liter per minute to approximately 0.200 (√kPa) / liter per minute with respect to the airflow, as described in Claim 1.

3. The inhalation device attachment according to claim 1, wherein the first pressure sensor and the second pressure sensor are digital sensors, and their outputs are in digital format.

4. The inhalation device attachment according to claim 1, wherein the second pressure sensor further detects atmospheric pressure.

5. The suction device attachment according to claim 1, wherein the second pressure sensor utilizes the detected atmospheric pressure to calibrate the measured pressure drop as needed.

6. Furthermore, the inhaler accessory according to claim 1 includes a laser beam, Doppler sensor, infrared sensor, or other sensing beam configured to detect the characteristic profiles of multiple parts of the inhaler or other drugs.

7. The dry powder inhaler device according to claim 1, wherein the dry powder inhaler device comprises a cartridge and a dry powder formulation.

8. The inhalation device accessory according to claim 7, wherein the dry powder formulation comprises diketopiperazine and at least one active ingredient.

9. The inhaler accessory according to claim 1, further comprising one or more of the following: a color detection sensor for sensing the color of an inhaler cartridge or other drug package loaded into the inhaler; an RFID reader for reading an RFID tag located in the cartridge or other drug package loaded into the inhaler; and an image detection sensor capable of identifying characters, codes, or text information provided on the inhaler, the inhaler cartridge, or other drug package.

10. The inhalation device accessory according to claim 1, further comprising a wireless transceiver, the wireless transceiver which transmits data to a remote processing system.

11. The inhalation device attachment according to claim 10, wherein the remote processing system displays a pressure difference versus time curve and indicates whether the user of the inhalation device has succeeded or failed.

12. The inhalation device attachment according to claim 1, further comprising an electronic board.

13. The suction device attachment according to claim 12, wherein the electronic board is connected to the microprocessor, the display, and the first and second pressure sensors.

14. The inhalation device attachment according to claim 13, further comprising an on / off button and an indicator connected to the electronic board.

15. The inhalation device attachment according to claim 1, further comprising a port capable of transmitting or receiving data.

16. The inhaler accessory according to claim 1, further comprising a sensor for detecting an audio signal generated by the inhaler.

17. The inhalation device accessory according to claim 16, wherein the audio signal includes the intensity of the audio signal, the frequency of the audio signal, or a combination thereof.

18. The inhalation device accessory according to claim 1, wherein the display is an LED display or an LCD display.

19. The inhalation device accessory according to claim 1, wherein the display is an interactive display.

20. The inhalation device attachment according to claim 1, further comprising a battery as a power source.

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