Equipment, systems, and methods for detecting and monitoring inhalation

Abstract

To provide an interactive apparatus and methods 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 for communicating with a display in order to assess a subject's use of an inhalation system concurrently with execution of inhalation, and thus the subject's inhalation can be evaluated as well as performance of the inhalation system. The system can also detect identification information of a medicament, its dosage, lot, expiration, etc. and a characteristics profile of a dry powder formulation emitted from the inhalation system in use.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] Cross - reference to related applications This application claims the benefits of U.S. Provisional Patent Application No. 62 / 338,971, filed on May 19, 2016 the entire disclosure of which is incorporated herein by reference.

[0002] An interactive device and method for recording, transferring, and displaying physical measurement values in real - time based on physiological states generated while a subject is performing an inhalation operation are described herein.

Background Art

[0003] In treating local or systemic diseases, inhalation devices for administering therapeutic substances via the airway especially for delivery to the lungs, are commercially available. For example, for the treatment of asthma, respiratory infections, and systemic diseases such as diabetes, nebulizers, devices filled with spray gas and dry powder inhalers have been used.

[0004] In treating diseases, the efficiency of delivering the required dosage of a therapeutic substance to a patient depends on the efficiency of the device and the overall efficiency can be improved by providing an appropriate feedback mechanism to the patient, clinician, or physician during the use of the device, for example, to teach the patient appropriate inhalation techniques. Improper use of the device or poor inhalation techniques can lead to a lack of efficiency in treating the disease. For example, administering a therapeutic substance at a dosage less than or greater than intended can be harmful to the patient. To efficiently deliver a therapeutic substance to the airway, the patient ​​​​Persons or users may receive training or instruction on how to use the device in an appropriate manner. ru.

[0005] Dry powder inhalers, used to deliver drugs to the lungs, are typically supplied in bulk. These are hard gelatin capsules, cartridges, or blister packs, which are used for taking medication. The dosage of powdered prescription medication, divided into individual doses and stored in compartments for each unit. It includes. For medication reproducibility, the prescribed drugs must be uniform and consistent and reproducible. It is necessary to be able to deliver the dose to the patient with the desired effect. Therefore, for example, the necessary dose Optimizing prescriptions by ensuring patients perform the correct inhalation technique to achieve their medication goals. Medication can be improved.

[0006] A device for training patients to properly deliver therapeutic substances via a pulmonary tube is available. For example, it is described in U.S. Patent No. 5,333,106, and this patent is for aerosols. Based on volume-to-airflow data using proper inhalation procedures in inhaler use. We disclose equipment for interactive patient training, including feedback displays. Yes. U.S. Patent Application No. 10 / 759,859 (U.S. Patent Application Publication No. 2004 / 0 Specification No. 187869 describes a training device for drug inhalers, such as dry powder inhalers. This training device measures the pressure difference to determine the peak of the suction velocity and suction flow rate. It is based on displaying a single value that corresponds to both, and is a simulator for a dry powder inhaler. Use this.

[0007] Regarding dry powder inhalers, U.S. Patent No. 8,499,757 and U.S. Patent No. 8, All disclosures taught in Specification No. 636,001 are made apparent by reference in whole. These are included in the detailed manual, but they include dry powder inhalers and cartridges as described therein. The system allows the inhaler and the powder in the capsule or cartridge to be used during the inhalation procedure. By crushing the mass of the prescription, primary drug particles or a suitable inhalation stream are produced. It can be done. There are many advantages to delivering drugs via the pulmonary circulation, rather than through the arteries. To ensure rapid absorption, to prevent drug degradation, which is the first barrier to entry due to liver metabolism, for example For example, it is less unpleasant and easier to use compared to other methods of medication such as injections. These devices have been used in clinical settings and are currently available commercially.

[0008] Interactive device and method for profiling inhalation activity (U.S. Patent) This disclosure is made in Patent No. 9,364,619, and is fully available herein by reference. It will be incorporated into it. [Overview of the Initiative] [Problems that the invention aims to solve]

[0009] To maximize accuracy and minimize training by subjects for proper use of the inhalation system The minimum number of subjects during activities and the use of the inhalation system and throughout the entire course of treatment. Improvements in the design and manufacture of inhalers that require only monitoring, and furthermore, inhalers and drug packages The flexibility of application to inhaler components, including the suction cup, and the reusability of such an entire system. There is a need for improvement in the relevant technical field. This disclosure provides equipment that achieves these objectives. And present the methods. [Means for solving the problem]

[0010] An interactive device for detecting and measuring inhalation characteristic parameters of an inhalation system during use, including the use of an inhaler by a patient of the inhaler and the device cooperating therewith, is described herein. In the disclosed embodiments, the device and the method of using the device are useful for, for example, collecting data generated from a subject's inhalation maneuvers and identifying the effort required to deliver an appropriate or therapeutic dosage by an inhaler provided to the subject for use in a treatment plan, thereby detecting, detecting, measuring, and monitoring the subject's characteristic inhalation profile or breathing pattern. The device and method are also useful for training / instructing a subject to use an inhaler to efficiently treat his / her disease, disorder, or condition, whereby the subject receives an appropriate dosage of the delivered medicament. In certain embodiments, the device can comprise any inhaler, particularly a high resistance dry powder inhaler for delivering one or more pharmaceutically active ingredients or drugs to the lungs, thereby treating the subject's pulmonary and systemic circulation. In some embodiments, the dry powder inhaler is breath actuated and the magnitude of the effort exerted by the patient during inhalation can be observed and displayed simultaneously with the actual inhalation being performed. An illustrative embodiment of the inhalation device and system disclosed herein comprises an inhaler accessory device that is an individual device and is attachable or mountable to an inhaler such that it can be in close contact with or attached to the inhaler during use and removable from the inhaler after use. In the disclosed embodiments, the device and the method of using the device are useful for, for example, collecting data generated from a subject's inhalation maneuvers and identifying the effort required to deliver an appropriate or therapeutic dosage by an inhaler provided to the subject for use in a treatment plan, thereby detecting, detecting, measuring, and monitoring the subject's characteristic inhalation profile or breathing pattern. collecting data generated from a subject's inhalation maneuvers and identifying the effort required to deliver an appropriate or therapeutic dosage by an inhaler provided to the subject for use in a treatment plan thereby detecting, detecting, measuring, and monitoring the subject's characteristic inhalation profile or breathing pattern thereby detecting, detecting, measuring, and monitoring the subject's characteristic inhalation profile or breathing pattern The device and method are also useful for training / instructing a subject to use an inhaler to efficiently treat his / her disease, disorder, or condition The device and method are also useful for training / instructing a subject to use an inhaler to efficiently treat his / her disease, disorder, or condition whereby the subject receives an appropriate dosage of the delivered medicament In certain embodiments, the device can comprise any inhaler, particularly a high resistance dry powder inhaler for delivering one or more pharmaceutically active ingredients or drugs to the lungs In certain embodiments, the device can comprise any inhaler, particularly a high resistance dry powder inhaler for delivering one or more pharmaceutically active ingredients or drugs to the lungs thereby treating the subject's pulmonary and systemic circulation In some embodiments, the dry powder inhaler is breath actuated and the magnitude of the effort exerted by the patient during inhalation can be observed and displayed simultaneously with the actual inhalation being performed and displayed simultaneously with the actual inhalation being performed

[0011] An illustrative embodiment of the inhalation device and system disclosed herein comprises an inhaler accessory device that is an individual device and is attachable or mountable to an inhaler such that it can be in close contact with or attached to the inhaler during use and removable from the inhaler after use is attachable or mountable to an inhaler such that it can be in close contact with or attached to the inhaler during use and removable from the inhaler after use

[0012] In some embodiments, an inhaler used by a patient and a fitting for the inhaler or A detection and monitoring system comprising corresponding inhaler accessories configured to fit together It is provided so that the inhaler can be removed or detached from the inhaler accessories. The patient self-administers the medication as instructed by the doctor regarding inhalation. The inhaler can be picked up and used. The inhaler attachments are the inhaler prescribed to the patient. A body structurally configured to engage with, for example, a light-emitting diode (LED) ( For example, to turn on the power, and to check the battery charge status or other statuses. This includes a display screen equipped with a liquid crystal display (LCD) for displaying visual signals. It can be miniaturized to fit any display means and inhaler accessories, or A touchscreen or other part of the detection and monitoring system can be placed separately. It features an interactive display and includes a microprocessor and one or more sensors. It includes an electronic circuit board. In some embodiments, the inhaler accessory includes a computer and wireless Or a receiver and transmitter for detecting signals emitted from a wired inhaler or The applicator receives information from the inhalation operation performed by the patient or user. Mobile information displayed in real time, simultaneously with what is happening, either during the session or by another means. It includes a terminal (PDA), tablet, and / or mobile phone. The inhaler accessory is Preferably, a serial (for example) is used to enable data transfer and battery charging. This includes USB ports and other ports.

[0013] In some embodiments, an inhaler accessory is provided for attachment to the inhaler of a subject. The process involves activating the inhaler attachment system and having the subject inhale simultaneously. Monitoring the subject's inhalation with the attached device and ensuring effective delivery of the treatment to the respiratory system To facilitate the training and / or monitoring of subjects in order to achieve optimal or appropriate exhalation control. A method is provided that includes the following: The detection and monitoring system determines the preferred flow profile. To achieve this for each individual, we train subjects to use the inhalation device appropriately. This facilitates the delivery of drugs and thereby achieves optimal drug delivery. The equipment and methods are as follows: Furthermore, the performance of the inhalation system provided to the patient, for example, detection of the delivered dosage, delivery The quantification of the drug being administered, the elimination period of the delivered dose, and the number of doses administered to the subject are monitored. And when storing data in real time and / or for future analysis It can be used to monitor the mechanical integrity of the inhalation system. In one embodiment, Inhalers or inhaler components (such as cartridges) used with inhaler accessories are For example, radio frequency identification (RFID), color coding, laser etching, text This may include codes or identifiers such as the following.

[0014] In an exemplary embodiment, the inhaler accessory for the inhalation monitoring system is interactive. It can be designed to operate in a flexible manner, for example, the device can enable remote data acquisition. It can be equipped with a wireless communication interface, and its data can be used in an interactive way. It provides data display, data recording, and / or web-based information transfer. Based on computers, tablets, smartphones, or other microprocessors It can be transmitted to the system. Alternatively, in other exemplary embodiments, wired communication input It can be equipped with a tough face.

[0015] In one exemplary embodiment, the device is, for example, specified in U.S. Patent No. 7,305,986. Detailed notes and U.S. Patent No. 7,464,706, U.S. Patent Application No. 12 / 413,40 As described in Specification No. 5 and U.S. Patent Application No. 12 / 484,125 They can be adapted to high-resistance dry powder suction systems, and all their disclosures are, All that is disclosed with respect to dry powder inhalers is made clear by reference to the whole. It will be incorporated into the specifications. The device has or has a cartridge for storing the drug prescription. It does not include a dry powder inhaler, and does not include pressure sensors, temperature sensors, acoustic sensors, and optical sensors. One of the following: electrical, electronic, electromechanical, electromagnetic, photonic, or light-powered Multiple converters, signal conditioning circuits and / or software programs, and electronic signal transmission It may include a signaling mechanism and an output display. In such an exemplary embodiment, The equipment includes analog or digital sensors, appropriate signal regulators such as amplifiers, and signal fillers. Microprocessor for tarring, analog-to-digital conversion, and onboard processing, and Furthermore, remote computing for subsequent signal processing and / or real-time output display. Along with a wireless communication device that communicates with a tablet, mobile phone, or personal digital assistant (PDA). It can be used for this purpose. The device stores the unit dose in a cartridge that has been pre-measured. To be used to deliver a pharmaceutical composition containing an active ingredient for delivery to the pulmonary circulation. This is possible. In an alternative exemplary embodiment, the detection and monitoring device is either empty or delivery to the lungs. An inhalation system equipped with a dry powder inhaler having a cartridge capable of storing suitable dry powder It can be mounted on top of or inside the suction system.

[0016] Dry powders consisting of fine particles suitable for delivery to the lungs are, for example, U.S. Patent No. 8,499,7 Technology such as that disclosed in U.S. Patent No. 57 and U.S. Patent No. 8,636,001 They are well known in the field, and their disclosures are how they disclose with respect to fine particles. The entirety of the following is incorporated herein by reference. Each exemplary In one embodiment, the dry powder and active ingredient are, for example, proteins, peptides, or polypeptides. Butyrate and combinations thereof can be used, as well as insulin, glucagon-like peptides. Endocrine hormones such as GLP-1, paratyloid hormones, or their analogues. It can be made into a mon.

[0017] In one embodiment, the dry powder formulation for delivery to the pulmonary circulation includes peptides, proteins From active ingredients or agents such as nitrates, hormones, their analogues, or combinations thereof This active ingredient is insulin, calcitonin, growth hormone, treprostinil, Palonosetron, Tobramycin, Filgastrin, Erythropoietin, Granulocyte Mac Lophage colony-stimulating factor (GM-CSF), chorionic gonadotropin-releasing factor, luteal phase release Hormone release, follicle-stimulating hormone (FSH), vasoactive intestinal peptide, parathyroid hormone (including black bear PTH), parathyroid hormone-related proteins, glucagon-like peptides - 1 (GLP-1), exendin, plumrintide, oxytomodulin, peptide YY, deoxyribonuclease 1, interleukin 2-inducible tyrosine kinase, b Luton's tyrosine kinase (BTK), inositol-required kinase 1 (IRE1), and These are analogs, active fragments, PC-DAC modified derivatives, or their O-glycosylated forms. The substance is an antimicrobial agent or an antifungal agent. In certain embodiments, the pharmaceutical composition is Alternatively, the dried powder formulation consists of fumaryldiketopiperazine, and the active ingredient is insulin, adenocarcinoma. Thyroid hormone 1-34, GLP-1, oxytomodulin, peptide YY, heparin , parathyroid hormone-releasing peptide (PTHrP), 5-hydroxytryptamine receptor Neurotransmissions including prostacyclin or PGI2, epinephrine, and norepinephrine. A substance agonist and antagonist, and one or more selected from their analogues There are multiple things.

[0018] In one exemplary embodiment described herein, the device communicates with a dry powder inhaler. Equipped with sensors, the sensors are generated from the pressure, flow rate, temperature, and dry powder suction system. It can detect at least one signal including an acoustic signal, and can analyze, store, print, and It can transmit a signal to at least one device for display. Such exemplary In one embodiment, the sensor is located inside the dry powder inhaler or can be attached to the dry powder inhaler. This sensor is configured to function as a microphone.

[0019] In one exemplary embodiment, the intake system has high resistance to the airflow, and the resistance value is every Approximately 0.065 (√kPa) / liter per minute ~ approximately 0.200 (√kPa) / liter per minute It is equipped with a dry powder inhaler. A high-resistance inhalation system can be installed in the detection and monitoring equipment. In some embodiments, the sensor detects the intrinsic characteristics generated by the inhaler in use. The signal can be detected. In another exemplary embodiment, the sensor is an acoustic detection device or a microphone It is an acoustic sensor including a lophone, which transmits acoustic signals within the system in wired or wireless mode. It is configured to transmit to at least one other device as described herein, drying The detection and monitoring equipment for the powder inhaler is further configured to analyze and process the signal. An analog device that transmits at least one signal, such as an acoustic signal, to a microprocessor. It can be associated with a digital converter. In another exemplary embodiment, at least one This device is an analog-to-digital converter.

[0020] In one exemplary embodiment, a monitoring device comprising at least one sensor and an analog A monitoring system for a dry powder inhaler, comprising a digital converter and a data storage medium, is described. It is contained within this data storage medium, and this data storage medium can be executed by a processing unit that implements the algorithm. The algorithm is capable of including a set of machine-readable instructions, and includes at least one The steps include receiving data from the sensor, filtering the data, and The process involves converting data, analyzing the data, and using the data to monitor patients. Instructions for manipulating data include one or more of the following steps.

[0021] In an exemplary embodiment where at least one sensor is a microphone, the sensor absorbs Any location inside the inhaler, for example, inside the airflow conduit, inside the wall of the inhaler, or in the suction chamber. It is provided as a separate component outside the input device. In another exemplary embodiment, the monitoring device is A removable device that can be attached to or mounted on a dry powder inhaler. This can be done. In yet another exemplary embodiment, the monitoring device is used for real-time suction. It provides a graphical display using a graph diagram.

[0022] In another exemplary embodiment, the acoustic signal is the amplitude of the acoustic signal, the frequency of the acoustic signal, or It is a combination of those. In yet another exemplary embodiment, the sensor further has different frequencies The number of measures at least one acoustic signal. In another exemplary embodiment, a dry powder inhaler It further includes a cartridge, which contains dry powder for delivery to the lungs. Furthermore, the dried powder contains diketopiperazine microparticles and at least one active It may include components. In yet another embodiment, at least one drug is an insulin Phosphorus, GLP-1, parathyroid hormone, calcitonin, their analogues, or their Includes combinations.

[0023] In a further embodiment, the detection and / or monitoring device receives a signal from the delivered dose. It is configured to detect the inhaler in use. In this embodiment, the detection and monitoring system is configured to detect the inhaler in use. The movement of powder particles within the cartridge system is determined by the start of powder delivery from the cartridge. Furthermore, the sensor can detect the end of powder particle delivery, and the sensor detects the acoustic and inhalation signals of the inhaler. The system detects changes in the essential acoustic properties of powder particles emitted from the stem. The data obtained from the detection... The system analyzes this and determines the amount of medication released or delivered through the inhalation system, and the delivery of the dose. The elapsed time and the performance of the inhalation system can be correlated for this purpose. ru.

[0024] In another exemplary embodiment, the detection and monitoring device includes a jacket or saucer for the dry powder inhaler. This implementation can be provided as an attachable and detachable device such as a dollar structure. In this state, the removable device does not change the structure or configuration of the dry powder inhaler. To facilitate the use of the inhalation system. Therefore, once the characteristic performance of the inhaler is Once the size is determined and the subject is able to use it appropriately, the same inhaler It can be used without a jacket. In the embodiments of this specification, a small microphone Sensors such as can be suitably mounted in any area of ​​the jacket, for example, on the jacket Alternatively, it can be embedded in the wall of the adapter, or it can extend from the wall of the jacket. It is also possible. In this embodiment, the detection and monitoring device detects the dry powder inhaler and cartridge in use. The acoustic characteristics emitted from the system can be obtained with greater precision.

[0025] One embodiment describes a method for measuring the pressure difference during an inhalation operation. This method involves providing a subject with an inhaler, wherein the inhaler generates , at least one amplitude of the acoustic signal, at least one frequency of the acoustic signal, or those A sensor configured to detect a combination of the following is provided, and the subject inhales for at least 1 second. To provide, to offer, and the microprocess of the computer system that generates the dataset. Using the algorithm provided by the setter, at least one amplitude of the acoustic signal, prior Analyzing at least one frequency of the recorded acoustic signal, or a combination thereof, and over time This includes displaying, printing, or storing the dataset as a function of pressure.

[0026] In further embodiments, a monitoring system for a dry powder inhaler is described herein. The monitoring system includes at least one sensor, including an acoustic sensor and a Doppler sensor. The system comprises a monitoring device, an analog-to-digital converter, and a data storage medium, and the data storage The medium is machine-readable and executable by a processing unit that implements the algorithm. The algorithm includes a set of instructions, and the algorithm receives data from at least one sensor. The steps are: a step to perform the operation, a step to filter the data, and a step to transform the data. The data includes steps of analyzing the data and using the data to monitor the patient. Includes instructions for operating the device.

[0027] Furthermore, in some embodiments, a method for measuring the pressure difference during the suction operation is described. The method is described in the specification, and the method is to provide an inhaler to a subject, However, at least one amplitude of the acoustic signal generated from the inhaler, at least one of the acoustic signals A sensor configured to detect one or a combination thereof is provided to the subject. Provide the subject to inhale for at least one second, and generate the dataset using a computer. Using the algorithm provided by the system, at least one vibration of the acoustic signal Analyzing the width, at least one frequency of the acoustic signal, or a combination thereof, and time This includes displaying, printing, or storing the dataset as a function of pressure.

[0028] In other embodiments, an interactive device for monitoring inhalation performed by the user. A dry powder inhalation system is described herein, and its interactive dry powder The intake system includes at least one microprocessor and measures the flow of air or gas. One or more Doppler effect sensors and / or infrared sensors that can perform this function. An inhaler accessory equipped with an active sensor, and a sensory beam including a laser beam, RF Identifiable by ID, optical recognition, image sensors, etc., color, laser etching, printing. A dry powder inhaler equipped with a cartridge having a type identifier such as numbers or printed letters. It is equipped with a sensory beam that uses a cartridge to detect color, type of medication, dosage, etc. It can detect an identifier code that is configured as an integral part of the image. The image detection sensor is an optical sensor. To detect dosage or other identifiers using character recognition, onboard or remote It may be used in conjunction with computing. In some embodiments, dry powder inhalation is used. The pressure of the container ranges from 0.065 (√kPa) / liter per minute to 0.200 (√kPa) / liter per minute. The flow resistance value and a converter configured to detect the signal generated from the inhaler in use. The device and a display device configured to show the inhalation operation performed by the user in real time. It has the following. In another embodiment, the converter detects and measures the pressure difference within the inhaler. Furthermore, this converter detects and measures the flow rate through the air conduit of the dry powder inhaler. It can also be a flow meter configured as follows. This converter can, for example, receive from inside the inhaler. It can be a microphone configured to detect and measure the resulting acoustic signal. Cut.

[0029] In yet another embodiment, a detection and monitoring device for use with a dry powder inhaler is provided herein. The detection and monitoring device is described and structurally configured to fit a dry powder inhaler. It is equipped with a removable device, and the removable device is generated in the dry powder inhaler. Equipped with a microphone to detect sound, the dry powder inhaler operates at 0.065 (√kPa) per minute. It has a flow resistance value of 0.200 (√kPa) / liter per minute.

[0030] Furthermore, in some embodiments, a detection and monitoring device for a dry powder suction system is described. The dry powder inhalation system comprises a dry powder inhaler and a cartridge, and the detection and monitoring device The system detects acoustic signals generated from dry powder formulations released from a dry powder inhalation system. It is equipped with a microphone configured to do so.

[0031] In some embodiments, the dry powder inhaler comprises a housing, a movable member, and a mouthpiece. It is equipped with a movable member that can move the container from the powder storage position to the dispensing position. It is configured to be functional. In this embodiment and other embodiments, the movable member is located at the proximal end of the inhaler. It can be configured as part of the lid assembly and forms a part of the cartridge mounting area. In this embodiment, the mouthpiece is located on the cartridge mounting area when the inhaler is closed. It is constructed integrally with the lid or cover that covers the housing. The mouse pip is positioned downwards from the horizontal plane. By moving the case, the lid or cover moves in a direction that forms an angle with respect to the vertical position. Move the device, open the inhaler to access the inside, and load and remove the cartridge. It becomes possible to remove it. Conversely, moving the mouthpiece upwards from a vertical plane to a horizontal plane... This closes the inhaler, and the cartridge loaded on the inhaler and cartridge mounting area... An air passage opening is automatically created between the two.

[0032] In another embodiment, the dry powder inhaler comprises a main body, a housing, and a mouthpiece. The inhaler has an open position and a closed position, and accepts and holds the cartridge, and the inhaler When the receiving device is moved from the open position to the closed position, it moves from the storage position to the dispensing, administration, or dose delivery position. It has a mechanism configured to be operable to reconfigure the cartridge into place. It is structurally configured as follows. In a modified version of this embodiment, the mechanism also allows the inhaler to be used after use. When opening and removing the used cartridge, the cartridge attached to the inhaler is used for dispensing medication. It can be reconfigured from position to storage position. In some embodiments, the mechanism is The cartridge can be reconfigured into a disposable or discardable configuration after use.

[0033] In some embodiments, the body of the inhaler comprises a proximal portion with a mouthpiece, and a body, It is structurally configured as a slip-on cover over the main body and the internal components of the inhaler. It comprises a distal part with a housing, the housing having a distal end and a proximal end, the proximal end being, The inhaler body has an opening for fitting and sealing a portion of it. In some embodiments, The proximal end contacts or abuts against the inhaler body to seal the inhaler from the external environment. From its configuration, the inhaler moves the housing distally on the main body by translational motion. The inhaler loading and / or removal position is opened and allows for insertion or removal of the cartridge. It reaches the position. When the cartridge is attached to the inhaler, the distal end of the housing on the main body Then, through translational movement in the proximal direction, the cartridge moves from the containment configuration to the drug dispensing configuration, The cartridge container has a protrusion that extends beyond the opening at the proximal end, which is located inside the housing. Therefore, it is pushed to the medication configuration. In the closed configuration, the cartridge attached to the inhaler is inhaled. To access the dry powder in the cartridge during administration, use the mouthpiece. and are reconfigured to form further airflow channels with the surrounding air. This embodiment and others In this embodiment, the air passage of the cartridge in the medication configuration is an air inlet and a mouthpiece The mouthpiece has an air outlet that communicates with the air passage of the mouthpiece, and the mouthpiece has its own air inlet and air It has an exit.

[0034] In some embodiments, the body of the inhaler has a mouthpiece formed at the proximal end of the body. It is equipped with a port that communicates with the inside of the housing and the air outlet of the cartridge attached to the inhaler, and has an air conduit that can communicate directly with the ambient air. The inhaler body also has a mouth The spiece and structure are continuous and include a cartridge mounting area having a distal portion and a proximal portion, The distal and distal portions form a single component with the mouthpiece and can be inserted into the housing. In some embodiments, the main body and the housing are connected to the internal components. To reach the inhaler open configuration, it can be pulled away. In the open configuration of this embodiment, Cartridges containing dry powder are loaded or attached to the cartridge mounting area of ​​the main unit. The main body and housing can be pushed or pulled to open and close the inhaler. This is possible. In some embodiments, the housing allows the distal part of the body to move from an open configuration to a closed configuration. The top is movable, and they close the inhaler together and attach to the cartridge mounting area. This enables the formation of an air conduit through the cartridge. In this configuration, the inhaler is a mouthpiece When the user inhales orally through the device, the powder in the cartridge is released from the inhaler. The drug configuration is reached. In the drug configuration of this embodiment, the main body and the housing are in contact with each other. To prevent the inhalers from falling apart, one or more non-slip structures keep them together. It fits tightly. Examples of anti-slip functions are snap rings or detents, which are absorbed. It can generate a sound to notify the user that the device is ready for use. In some embodiments, the inhaler is a substantially rectangular shape, shorter in distal and proximal lengths. It has the shape of a housing on the main body, and the movement of the housing or vice versa is also done by pulling or pushing. Furthermore, from the longer side of the inhaler in the longitudinal section (first side and second side) outward This is achieved by an inhaler body having guide rails or tracks extending thereto. In this configuration, the inhaler body is designed to receive and guide ambient air into the internal chamber of the inhaler during inhalation. It is designed to have an opening at its distal end so that it fits into the opening at the distal end of the wedge. The housing also has grooves or slots for sliding along guide rails while moving. It is appropriately configured to have, and furthermore, a stop end to prevent disassembly of the inhaler, and mounting and suction After the receiving device is closed, it is equipped with a push element for setting the cartridge into the medication configuration. The basic method involves moving the cartridge cup or container relative to the cartridge lid, and then the cartridge... It forms an air passage through the mouthpiece, creating an air inlet and an air outlet, and the inhaler mouthpiece And in order to deliver aerosolized particles to the user, the powder in the cup is aerosolized during inhalation. To enable. In another embodiment, the push element also moves the cartridge assembly, A lid is placed over the entrance opening located in the floor portion of the void. One aspect of this embodiment. In this, the dry powder inhaler comprises a housing with a pressing element, and the housing is open By moving the housing parallel to the inhaler body from the open to closed configuration, the mouthpiece Install the cartridges so that they are aligned.

[0035] In some embodiments, the dry powder inhaler has a distal end that communicates with ambient air. It comprises a housing with an opening for suction. In some embodiments, the housing has an opening for suction. It consists of a cover that slides over the main body of the inhaler, and substantially encloses a part of the main body of the inhaler, housing The ing moves translationally along the distal part of the main body. The inhaler has two components, its internal compartments A first position to open the inhaler in order to access the chamber, and a proximal end to close the inhaler. It can reach a second position where it contacts. In some embodiments, the housing The distal portion is also movable relative to the proximal end in the horizontal plane and extends distally, in the inhaler It allows access to the internal components and completely encloses the inhaler body. Modification of this embodiment So, the distal part of the housing has a parallel structure or flat for engaging with the main body of the inhaler. It is equipped with a mechanism for locking the inhaler body to the housing, for example, The two parts are fixed together to maintain the medication configuration. In one embodiment, the housing is far The part has an opening at its distal end for communicating with the inside of the inhaler, and slides on the inhaler body. It has an opening configured to allow it to slide on the inhaler body. It comprises an outer surface, an inner surface, and a chamber configured to do so. In some embodiments, the inhaler The distal part has wings on its upper surface that are parallel to guide the airflow to the mouthpiece during inhalation. It has a shaped structure.

[0036] In an alternative embodiment, the mouthpiece includes various mechanisms, such as a hinge, which are movable members. The inhaler body is engaged by a spiral, and the cartridge cup or container is attached to the cartridge It is integrally constructed with a movable assembly that includes a rack for moving the lid. Possible assemblies accept cartridges attached to the inhaler and move from the storage position to the dispensing position. It is configured to be reconfigured to a different position, for example, by closing the device from an open configuration. The device can be designed to operate manually or automatically when moving the incoming components. In some embodiments, the mechanism for reconfiguring the cartridge is located in the mouthpiece. A sliding tray or thread is attached and is movable to the housing. To be equipped. In another embodiment, the mechanism is attached to or adapted to the inhaler, for example, It features a geared mechanism integrated into the hinge of the inhaler device. In the application mode, the device accepts the cartridge and operates to reconfigure it from the storage position to the dispensing position. The mechanism that can be configured is, for example, when the housing or mouthpiece rotates. , equipped with a cam that can reconfigure the cartridge. In some embodiments, Turning the spiece from the horizontal plane opens the inhaler and allows for cartridge installation or removal. This enables angular motion from the vertical plane to the horizontal plane, or the mouthpiece closes. and enables automatic reconfiguration of the cartridge from the storage position to the dispensing position. One embodiment So, the gear mechanism in operation has a cartridge cover positioned over the mouthpiece's inlet opening. Place the cup and translate it into the medication container.

[0037] In some embodiments, an inhaler used by the subject is provided to the subject for inhalation. Start the device and system and instruct the patient to inhale using the inhaler mouthpiece. By relying on the inhaler, the patient's inhalation profile can be determined using inhaler accessories that are compatible with the inhaler. The setting is determined. Simultaneously with the patient's breathing, the inhaler attachment measures the patient's breathing in real time. Detected by a system or indicator regarding such data generated Performs display of the monitored data. In this embodiment and other embodiments, the display is Bl uetooth(registered trademark), Zigbee(registered trademark), WiFi, SmartWav e, or microwave radio signal transmitters and receivers such as Z-Wave, or transceivers An algorithm application that communicates with a microprocessor on an inhaler accessory equipped with It can be viewed on a mobile phone, tablet, PDA, or computer equipped with this feature. The microwave radio signal is provided to a mobile phone that can communicate with the inhaler attachment. It can be detected by a microwave radio signal from a transceiver. In one embodiment, a microwave radio signal from a transceiver It can transmit data from a microprocessor and communicate with other computers. It can be received by the transceiver. In one embodiment, the inhaler accessory is a tablet It communicates with a personal digital assistant (PDA) or mobile phone, and tablets, PDAs, or mobile phones. When the phone is turned on, it can communicate with the inhaler attachment and the inhalation system. A graphical interface that can detect any information / signals generated from it. This allows you to access programmed applications that display a screen. [Brief explanation of the drawing]

[0038] [Figure 1] Figure 1 shows an isometric view of an embodiment of an accessory device for a wireless dry powder detection inhaler that is attached to an inhaler. [Figure 2] Figure 2 shows an isometric view of an embodiment of a wired dry powder detection device attached to an inhaler. [Figure 3] Figure 3 shows a top isometric view of an embodiment of the wireless detection and detection inhaler accessory device. [Figure 4] Figure 4 shows a bottom isometric view of an embodiment of the wireless detection and detection inhaler accessory device, and shows the electronic circuit board. [Figure 5] Figure 5 shows a top view of the electronic circuit board shown in Figure 4. [Figure 6] Figure 6 shows an isometric view of a dry powder inhaler connected to an embodiment of the detection inhaler accessory equipment shown in Figure 1, which includes an integrated signal indicator button. [Figure 7] Figure 7 shows an isometric view of a dry powder inhaler connected to an embodiment of a detection inhaler accessory, such as the one shown in Figure 2, which includes a local signal display button. [Figure 8] Figure 8 shows an isometric view of an embodiment of a wireless dry powder detection and detection inhaler accessory device that is attached to an inhaler and includes an integrated display screen. [Figure 9] Figure 9 shows a block diagram of an overall embodiment of the wireless detection and monitoring system disclosed herein. [Figure 10] Figure 10 shows a block diagram of an embodiment of the detection and monitoring system disclosed herein. [Figure 11] Figure 11 shows a block diagram of another embodiment of the detection and monitoring system disclosed herein. [Figure 12] Figure 12 visually illustrates the inhalation procedure performed by subjects instructed to inhale, in order to monitor the effectiveness of inhalation for medication administration. [Figure 13]Figure 13 shows a block diagram of an embodiment of a wireless detection and monitoring system disclosed herein, in which the inhaler accessory includes a pressure sensor. [Figure 14] Figure 14 shows a block diagram of an embodiment of a detection and monitoring system disclosed herein, in which the inhaler accessory includes a pressure sensor and a display unit. [Figure 15] Figure 15 shows a block diagram of another embodiment of the detection and monitoring system disclosed herein, in which the inhaler accessory includes a pressure sensor and a visual indicator. [Figure 16] Figure 16 shows a block diagram of an embodiment of a wireless detection and monitoring system disclosed herein, in which the inhaler accessory includes a color detection sensor and a pressure sensor. [Figure 17] Figure 17 shows a block diagram of an embodiment of a detection and monitoring system disclosed herein, in which the inhaler accessory includes a color detection sensor and a display unit. [Figure 18] Figure 18 shows a block diagram of another embodiment of the detection and monitoring system disclosed herein, in which the inhaler accessory includes a color detection sensor and a visual indicator. [Figure 19] Figure 19 shows how the system in Figure 16 can be used to train or monitor a user's inhalation. [Modes for carrying out the invention]

[0039] During inhalation with an inhaler, pressure or pressure drop and / or flow from the subject Instruments having an interactive system for measuring or monitoring real-time characteristic changes. A device and / or apparatus and method thereof are disclosed herein. This device includes an inhalation device and In conjunction with this, the subject is detected and monitored to maximize the efficiency of the subject's respiratory manipulation, and As a result, it can be used for training, and the appropriate dosage can be delivered when used. To detect the timing and proper performance of the inhalation system, during drug delivery, inhalation It can also be used to monitor. In one exemplary embodiment, the detection and monitoring device is It can be applied in combination with a high-resistance inhaler. In the embodiments described herein, detection monitoring The system uses an inhaler, and in particular, in combination with a dry powder inhaler, to perform many inhalation procedures. Sexual parameters can be measured, including the peak inhalation activity within 2 seconds of the start of inhalation. Total inhalation activity (PIP2), total inhalation activity in the first second of inhalation (AUC1), total inhalation activity of the patient Includes data generated to evaluate the volume and duration of inhalation. (Handheld inhaler) The system is described to consist of two parts, an inhaler and an inhaler accessory, but The present invention relates to a system and method for measuring or monitoring data and characteristics during input operations. The design sacrifices flexibility and reusability, but integrates the accessory functions into the inhaler itself. Those skilled in the art will understand that this can also be applied to digitized devices.

[0040] The device is suitable for attachment to an inhaler or for association with an inhaler in other cases. The instrument is equipped with an accessory device. The device measures pressure, airflow, air volume, humidity, and temperature. It can detect at least one measurement including degrees and convert them into electrical signals. It also includes another transducer or sensor. In some embodiments, the sensor passes through the inhaler. It can be equipped with a Doppler detector that can detect the flow of air or gas. In this embodiment, the sensor includes a pressure sensor capable of detecting a pressure drop during the inhalation operation. The included equipment provides appropriate signal filtering, amplification, and analog-to-digital conversion. An electronic circuit board having circuit elements including an adjustment circuit, and a display for signals or processed information. Simultaneously on the receiving computer or personal digital assistant (PDA), including a mobile phone. This includes processing circuits such as microprocessors for transferring signals generated in real time. And may further include wired or wireless communication interfaces, etc. In this configuration, the output display unit can be an interactive display unit, thereby allowing the display The display unit allows the physician and / or patient to see the achieved inhalation parameters. Visual aids are provided to facilitate this. The information obtained in this way can be used repeatedly by the subjects. It can serve as a teaching guide for performing effective inhalation operations in real time, and This facilitates proper inhalation delivery of the drug when self-administering. Another exemplary practice In this implementation model, data can be stored for later analysis.

[0041] Figures 1-7 show embodiments of a dry powder inhaler system or training device and its components. The training device interactive systems described herein are subject to U.S. Trademark No. 8499. U.S. Patent No. 757, U.S. Patent No. 8,636,001, and U.S. Provisional Patent Application No. 6 Suitable for high-resistance dry powder inhalers as disclosed in Specification No. 2 / 289,095 Therefore, those disclosures refer to all that they disclose with respect to dry powder inhalers. This is incorporated herein by means of.

[0042] 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 air outlet port for delivering powder to the user / patient. The inhaler 14 is equipped with a mouthpiece 15 having a to 17. Inhalation detection and monitoring system 1 0, 12 also involves attachment onto the inhaler 14, connection to the inhaler 14, or inhalation by other means. The inhaler accessory 18 is provided, which is suitable for association with the device 14. The device has an actuator button 19 for turning the power of systems 10 and 12 on / off. Includes. Air conduits must have at least one air conduit route that is dry for delivery to the individual when in use. To establish an air conduit pathway through a system that moves through a container that stores powder. , established between one or more air inlet ports. In some embodiments, inhaler The powder is not stored during patient training for the proper use of the inhaler. (Figures 1 and 2) In this embodiment, the inhaler 14 is a dry powder inhaler of the same type, and the inhaler accessory 18 is an inhaler. It can be fitted to the top surface of the input device 14. Figure 2 shows the connection to the power supply and / or computer. The diagram shows an inhaler accessory 18 having a wire 22 connected to the system.

[0043] Figure 3 shows a top view of another embodiment of the inhaler accessory 24 designed to fit an inhaler. An isometric view is shown. Figure 4 shows an isometric view of the bottom of equipment 24. As can be seen from Figures 3 and 4, The accessory device 24 preferably comprises a body having tabs 25, 25' for attachment to the inhaler. However, to engage the device with the inhaler, other types of fastening known to those skilled in the art are available. The device can be used. Preferably, the device 24 is used to start the device for use. This also includes the actuator button 26. In this embodiment, the body has a top surface 27 and a bottom surface 28. and has an electronic circuit board 30 attached to the bottom surface. Figure 4 shows the lower surface 28 integrally assembled Figures 4 and 5 show an embodiment of an inhaler accessory device 24 having an embedded electronic circuit board 30. The electronic circuit board 30 is further shown. Preferably, the electronic circuit board 30 is connected to the actuator button 26. An actuator 26' connected mechanically or by other means, a sensor 29, and a micro It comprises a processor 32. The microprocessor 32 receives the initial signal from the associated inhaler. It provides motion detection, processing, and communication of information / signals to a display device. In this embodiment, The sub-board 30 is configured as a signal processing / interface board. The sensor 29 is in use during suction. Acoustic sensors to detect sounds generated, or to detect pressure drops during suction. It can be any type of sensor, such as a pressure sensor. The inhaler attachment 24 includes Preferably, when the actuator button is pressed down, an electric motor is used to activate the system. A battery is also provided as a power source. The electronic equipment included in the inhaler accessory 24 is necessary for its function. It is provided as a separate circuit component on a separate board, connected by appropriate means as needed. Those skilled in the art will understand that this is possible. For example, the microprocessor 32 is Due to the placement requirements of the sensor 29, it may be located on a separate substrate from the sensor 29.

[0044] In another embodiment, the inhalation detection monitoring system includes an indicator as shown in Figures 6 and 7. A caterer is provided. Figure 6 shows the inhalation shown in Figure 1, with signal indicators 35 and 36. Figure 7 shows an isometric view of the dry powder inhaler connected to the device's accessories. The signal indicator 35 An isometric view of the dry powder inhaler connected to the inhaler accessory 18 shown in Figure 2, showing 36. The signal indicators 35 and 36 are preferably used to indicate a specific state to the user. These are photodiodes or other light indicators. For example, they can indicate successful drug inhalation. It can be used to indicate whether or not something has happened. In this case, for example, one indicator One can indicate a red signal light, and the other can indicate a green signal light while in operation. Signal indicators 35 and 36 indicate failure or success accordingly. Failure Intake Indicator The light (red light) indicates that the inhalation procedure performed on the subject or patient involves the inhalation of powder contained in the inhaler. This indicates that one or more of the specified criteria for inhaling the dose were not met, and that the inhalation was unsuccessful. The input indicator (green light) indicates that the subject or patient has performed the inhalation procedure and the powder contained in the inhaler is inhaled. To indicate that the appropriate criteria for delivering the dose are met. Alternatively, select a color based on the condition. If you can choose, or if, for example, you can use blinking to indicate a state, then only one. Signal indicators can be used. Other uses of signal indicators 35 and 36 include , power on / off, power error, or low battery indicator, or attached equipment This may include the connection status between the device and the inhaler.

[0045] Figure 8 shows an isometric view of an alternative embodiment of the wireless dry powder detection and suction system 12, and suction A display screen 44 is mounted on the input device 14 and integrally formed on the main body of the accessory device 42. This allows patients to visualize their inhalation activity and the inhalation process simultaneously. An inhaler accessory 42 is shown. In this embodiment, the inhaler accessory 42 is as shown in Figure 4. The device includes an electronic circuit board 30 as shown in 5, and the signal information related to the inhaler is transmitted via a microprocessor. The processed information obtained by step 32 is communicated to the display screen 44, and is preferred. Alternatively, a graphical display comparing the inhaler used to one or more predetermined standards. This is presented as follows. This graph and associated data points are preferably on the electronic substrate 30. Although stored locally, it can also be stored remotely. This embodiment and other embodiments Therefore, the prescribed standards for inhalers depend on the inhaler and medication used. In the embodiment shown in the figure, and in the embodiment shown therewith, the reference used is peak intake. The pressure, the amount of medication released, etc., are as previously shown.

[0046] Figures 9, 10, and 11 show various dynamics of the inhalation detection and monitoring system shown in Figures 1-8. A working embodiment is shown. Figure 9 shows the overall wireless detection and monitoring system 50 disclosed herein. A block diagram of a typical embodiment is shown. In Figure 9, the system 50 has two components: The system comprises an accessory device 54 and a processing system 56. In this embodiment, the inhaler accessory device 54 is Two sensors 51, 52, a battery 53, a microprocessor 70, and a wireless communication device or It includes an electronic circuit board having a transceiver 72, an analog sensor 51 and a digital sensor 5 2. When the inhalation detection monitoring systems 10 and 12 are activated or turned on, the inhaler 1 Adjacent to the inhaler airflow conduit, so that an acoustic signal or pressure difference can be detected. The system is arranged as follows. The system is connected to a power source such as a battery 53 that also provides power to the system. The power is turned on by pressing down the connected actuator buttons 19 and 26. Alternatively, the system can be powered via a wire, such as a USB port. Sensors 51, 5 2 is preferably any air conduit in or adjacent to the air conduit of the inhaler attachments 18, 24 They are positioned at a point. In some exemplary embodiments, sensors 18, 24 are located in the main body of the accessory device. It is placed in the air conduit inside the body 20, or near the mouthpiece 15 of the inhaler being used. It is possible.

[0047] The processing system 56 is a PDA, tablet, mobile phone, or computer 57, and a table Display unit 58, wireless communication device 59, digital storage device, web interface, print Output 55 can be in the form of an output or email, etc. The display unit 58, the wireless communication device 59, and the output 55 are not separate elements, but rather a PDA / tablet. It may simply be present in a let / mobile phone / computer 57, as a person skilled in the art would know. This should be understood as follows: In this exemplary embodiment, the user presses the power button, for example, The inhaler attachment 54 is activated by pressing down button 19 on the device 10. This is done, and the processing system 56 is also started. The computer 57 preferably contains the inhalation activity. A form of software application or program designed to collect and display information. The algorithm for the state is included. The software program embedded in computer 57 is opened. When started, a start signal appears on the display unit 58. When the system is started, the user's inhalation Due to 60, a pressure drop occurs inside the inhaler training device 50, and this pressure drop is detected by sensors 51, 5 It is converted into an electrical signal by one or more of the two. In this embodiment, sensor 51 52 is analog or digital, pressure, flow, sound, light, gas, humidity, or temperature. It can be used as a converter. Next, the electrical signal generated from the sensor 51 is used to adjust the signal. The signal is transmitted to the regulator 61, which removes unwanted parts of the signal such as noise. Then, it is adjusted. The generated electrical signal 62 is transmitted to the band limiter 63, which reduces the signal frequency to a desired reduction range. The data that needs to be analyzed is then selected, and the signal is transmitted to the signal amplifier 64. In the signal amplifier 64, the selected signal is amplified to a predetermined voltage range, and the amplified signal It can be transmitted as signal 65. Then, the amplified signal 65 is analog digital It is converted to a digital signal 67 via the converter 66. Adjustment, filtering, amplification, and It is possible to use certain "smart" sensors that integrate some of the conversion functions into the sensor itself. This should be understood by those skilled in the art. Therefore, these subsequent requirements of this specification References to the element can be replaced with the use of such an integrated sensor. Next, the digital The TAL signal 67 is received by the microprocessor 70 and transmitted wirelessly (for example, via Bluetooth) Computer 57 having a wireless communication device 59 for receiving th(registered trademark) signal 69 For transmission to the wireless technology standard (for example, Bluetooth), via connection 74. The transmission is transmitted to a wireless communication device or transceiver 72 designed for use with the registered trademark. It is built into / programmed in the microprocessor 70 or computer 57. The software program indicates the presence of a wireless device, and contacts the wireless communication device or transceiver 59. This includes continuing and passing data from element to element by wireless signal 69. The program facilitates the basic functions of the input device and its accessories. The program also receives electrical signals from sensors 1 and 2. This is converted into a pressure value that can be visually displayed on the display unit 58. The display unit 58 uses LEDs and OLE A screen equipped with a D, LCD, touchscreen, or other interactive display unit. It is possible. In one embodiment, the baseline curve for the user is the system 50 It is stored and provided to the display unit 58 along with the inhalation signal information. The baseline curve is the inhalation Inhaler Instructions indicate the performance level for each type of inhaler and serve as a reference standard to guide users in their inhalation procedures. The approximately accurate dosage measured using the mixing device 10 is delivered to the patient. Therefore, during inhalation... The user can visually compare their inhalation technique to a baseline. During training, it is possible to remove the drug inhaler, thereby preventing incorrect inhalation techniques. No drugs will go to waste. In this way, the user knows when the drug is actually inhaled. It is possible to change one's inhalation activity to conform to the standard conditions. Performed by the subject. The display data for each inhalation can be saved to output 55 via the second connection 76. This data can be stored or transferred depending on the situation. For example, output 55 It can take the form of a disk drive, flash drive, or printer. Alternatively, you can email or text us for review or further training as needed. The signal may be transmitted to the physician via a t-t. In some embodiments, the signal from the inhalation training device It can be transmitted to a computer / PDA / mobile phone / tablet, and computer / P The signal from the DA / mobile phone / tablet can be received by the inhalation training device, This establishes bidirectional communication between the two components. For example, the user can input the patient number Specific information such as medication strength and comments about the patient's condition is entered into computer 57. This is possible. In this embodiment and other embodiments, the sensor 52 is a digital sensor, and It is a sensor that can generate digital output. It is an accelerometer, Doppler sensor, lu It can be an xometer or laser, and the detected signal is transmitted to the onboard microphone. It can be transmitted directly to the loprocessor, and then analyzed, processed, and transmitted. The signal information from the microprocessor can be analyzed and processed using algorithms. This allows for the creation of a graphical interface that can display that data, for example. Convert to a pressure-time curve using the signal from sensor 52. If both are adopted, the signal from sensor 52 is converted. This can transmit information about flow and pressure differences that are different from the signal from sensor 51.

[0048] Furthermore, other onboard devices 78 have microphones via one or more cables 79. It can send data to the microprocessor 70, and also receive data from the microprocessor 70. It can receive. For example, other onboard devices include digital output sensors, temperature sensors, etc. Includes sensors, light-emitting diodes (LEDs), sound warning devices, and other onboard sensors. These onboard devices can be used for LED lighting or such failure / failure An audible indicator can be used to output success / failure criteria for inhalation. Temperature, humidity, or other environmental data are used to determine the environment in which the inhaler was used. It is possible.

[0049] Following signal amplification, the output of sensor 51 is sent to wireless communication device 7. It can be sent directly to computer 506 via 2 instead, and the computer will It can perform analog-to-digital conversion and other necessary analysis steps.

[0050] Figure 10 shows a block of an integrated display unit, representing an embodiment of the detection and monitoring system disclosed in Figure 8. The diagram shows the inhalation detection device 82, which includes a built-in display unit 84, a microprocessor 86, and The system includes an onboard electronics system having a analog sensor 88 and a digital sensor 89. The system is equipped with an inhaler accessory. When the system is in use, the user 90 presses the actuator button 19 By pressing down, it starts up with power supplied from battery 92. Inhalation is performed through an inhaler equipped with an inhaler accessory and compatible inhaler electronic system 82. At that time, one or more of the sensors 88 and 89 are transmitted to the microprocessor 86. It generates a signal that removes excess noise. For example, an acoustic sensor or microphone 88 removes excess noise. It can be used to generate an electrical signal 94 that is transmitted to the signal regulator 96 for removal. Then, the electrical signal is sent to the bandwidth limiter 98 to reduce the data that needs to be analyzed. The signal frequency is reduced to the desired range, and then the signal is transmitted to the signal amplifier 95. The signal is amplified and transmitted to the analog-to-digital converter 97, and the digital signal is analyzed. The information is communicated to the onboard microprocessor 86 for conversion into a graph and visualization. It is transmitted to the display unit 84 for this purpose. The digital sensor 89 detects the signal and Then, in order to generate a set of signals for transmission to the microprocessor 86, the sensor 88 Alternatively, or in conjunction with sensor 88, the signal is analyzed and stored. This is then transmitted to the display unit 82. Other devices, including other sensors 99, also transmit to the inhaler. Alternatively, it can be included to detect other parameters of the system.

[0051] Figure 11 is not an integrated display unit showing the operating parts of the system, but rather a visual indicator of performance. A block diagram of an embodiment of the detection and monitoring system 100 disclosed herein, which has a tactile feedback loop, is shown. In this embodiment, there are two sensors, an analog sensor 101 and a digital sensor 102. A system 100 is provided. When the system 100, which is powered by battery 103, is started, the patient / user User 105 inhales and generates signals such as sound from the airflow traveling through the inhaler conduit. Sensors 101 and 102 are activated, generate signals from the inhaler, and transmit those signals downstream. Sensor 102 can be a Doppler that can receive signals, for example, from airflow detection. The force signal can be analog or digital. The output signal from sensor 102 is If it's digital, they use microprocessors for analyzing and processing incoming information. The signal is transmitted directly to the sensor 110. At the same time, the sensor 101 receives the electrical signal detected by the inhaler. The signal is then generated through the signal adjuster 106 to remove excess noise, and then adjusted. The signal is transmitted to the bandwidth limiter 108 to select the data to be analyzed. The limited signal is transmitted to the signal amplifier 109, where the signal is amplified and converted from analog to digital. It is transmitted to converter 112. The received signal is then converted into a digital signal, even For analysis and processing in algorithms that convert data into visual or optical signals. The signal is transmitted to the onboard microprocessor and displays visual indicators such as green or red light. It can be displayed as a caterer, and is suitable for delivering dry powder dosages to patients during inhalation activity. Whether it is a "success" in the sense of inhalation through diligent activity, or whether the patient's inhalation activity is This indicates whether the dry powder dosage was not adequately delivered from the stopped inhaler. In this embodiment, other sensors, signal modifiers, or amplifiers may be used, depending on the type of sensor used. The instrument, and other onboard devices 115 such as analog-to-digital converters, are integrated into the circuit. It is possible. For example, an inhaler accessory may have two or more analog sensors. Therefore, electrical signals are sent to a microprocessor for information analysis and processing. It must pass through an analog-to-digital converter before being transmitted. Alternative Embodiments So, we use a digital sensor whose output signal can communicate directly with a microprocessor. It is possible.

[0052] In other embodiments, the inhaler accessories include a temperature sensor, a laser beam, and a Doppler sensor. luxometer, color sensor, text recognition, RFID, optical character recognition, optical identification It may have not just one, but one or more sensors, including pattern recognition. If the power signal is not a digital signal output, for example, when it reaches the microprocessor... analog signals that must be converted to digital signals for further analysis and processing. These sensors can be used as outputs. These sensors are preferably included on the inhaler accessory. Which medications are loaded into the inhaler for administration, and which cartons contain such medications? Identify the type of cartridge or the dosage loaded into the inhaler.

[0053] Figure 12 shows the tablet / computer / PDA / phone 57 of the processing system 56 in Figure 9. A screenshot is shown. Computer 57 also uses Bluetooth®. It is used to communicate remotely with the inhaler attachment 54 using another remote wireless technology, and inhalation The device attachment 54 is fitted to the inhaler, and when the system is activated, the subject uses the mouth of the inhaler. You are asked to inhale through the spit. The result obtained on the screen shown in Figure 12 The graph plots the inhalation activity on the y-axis in response to the inhalation operation, and the sensor (for example) For example, consider the pressure measurement and flow versus time (seconds) on the x-axis. The subject's inhalation activity is The curve A above the trapezoidal figure B at the bottom of the graph is represented by the outer limit of trapezoidal figure B (i.e., (Above the area) to empty the powder contents of the inhaler when the subject takes the dose. Efforts must be made to ensure that the amount of powder taken from the inhaler is inhaled efficiently and continuously. This is interpreted as indicating a threshold or minimum inhalation activity that must be met. Identification sensors as described herein include inhaler, drug type, dosage, lot, and breath. It detects and transmits data associated with things like energy. Such data is based on user instructions. It is processed to identify the corresponding threshold data. The trapezoid also indicates the maximum value the inhaler shows. Minimum characteristic standards, or the requirements that an inhaler requires to continuously deliver a dry powder dosage. The effort was demonstrated, and its delivery rate was greater than 90% of that of the patient. Figure 12 shows deep inhalation. Visually illustrate the inhalation procedure performed by a subject who has requested to perform the procedure. You can view the display screen on the tablet while it is running. Thus, the subjects performed perfectly within acceptable limits in area A.

[0054] Furthermore, Figure 12 shows the inhaler accessory 10 and baseline inhalation performance for drug identification. The criteria are shown. The curve A detected by the user is the warning area just above area B, and the warning area It is adjacent to an acceptable or preferred region C above region B and C. Furthermore, the warning area is designed to facilitate identification of the area when monitoring an individual's performance during inhalation. It can be given in different colors. Area B can be shown in red, for example, for the inhalation operation. The baseline conditions were not met, and therefore the delivery system could not effectively deliver the drug. It indicates that it is not optimal to reach. The warning area may be indicated in yellow, and the inhalation operation is This indicates a warning that efforts are approaching unacceptable results. The favorable area C is shown in green. This allows for inhalation performance that is an acceptable effort for effectively delivering the drug. This indicates that the displayed information, detected from one or more sensors on the device, is appropriate. This can be used by clinicians, physicians, or users to determine whether appropriate medication has been administered. If possible, or if that information is necessary to ensure the proper administration of the drug, It can be used to train users based on the requirements.

[0055] Figures 13, 14, and 15 show various inhalation detection and monitoring systems shown in Figures 1-8. An operational embodiment is shown. Figure 13 shows the overall wireless detection and monitoring system disclosed herein. A block diagram of a typical embodiment is shown. In Figure 13, system 120 consists of two components. The system comprises an inhaler training device or accessory equipment 124 and a processing system 126. The stem 126 includes a PDA, mobile phone, or computer 127, a display unit 128, and Linear communication device 129, digital storage device, web interface, printout, etc. It may include an output 125 that can be in a specific form. In this exemplary embodiment, The person presses down the power button, for example, button 19 on the training device 10, The inhaler training device or equipment 120 can be activated, and the processing system 126 can also be activated. When the software program built into computer 127 is started, a start signal is sent. The number appears on the display unit 128. In this embodiment, the auxiliary device 120 also provides power to the system. Press down the actuator buttons 19 and 26, which are connected to a power source such as batteries 123. When devices 10 and 12 are activated or turned on, the differential pressure from the inhaler In order to detect the absolute pressure of the environment from the inhaler 14, the inhaler air conduit is equipped with Preferably, it has two pressure sensors 121 and 122 that are arranged adjacent to each other. It is equipped with an electronic circuit board. When the system is started, the user's inhalation 130 triggers inhaler training. A pressure drop occurs within the device 120, and this pressure drop is measured by the sensor 121. The pressure sensor 122 is used to correct the differential pressure reading for atmospheric conditions. or provide a signal.

[0056] In this embodiment, sensors 121 and 122 are digital pressure sensors. Then, the signals generated by sensors 121 and 122 are sent to the microprocessor 131, The data is then transmitted to the wireless communication device 132. Microprocessor 131 or computer 12 The software program incorporated into 7 is for sensors 121 and 1 The signal generated in step 22 is used for LEDs, OLEDs, LCDs, touchscreens, or other applications. The display unit 58 can be made into a screen with an interactive display section, which can visually display information. Convert to a (corrected) pressure value.

[0057] Figure 14 shows a block diagram of an embodiment of the detection and monitoring system disclosed herein. The input detection device includes a built-in or integrated display unit 144 and a microprocessor 143. The system includes an onboard electronics system 140 having pressure sensors 141 and 142. The system is equipped with an inhaler accessory. When in use, the system is powered by the user 146 from the battery 145. It is started with the power supplied. Once the system is started, the user's inhalation 146 is used. A pressure drop occurs within the training device 140, and this pressure drop is measured by the sensor 141. The absolute pressure sensor 142 is used to correct the differential pressure reading for atmospheric conditions. Provides data or signals. In this embodiment, sensors 141 and 142 are digital It is a pressure sensor. When an analog sensor is implemented, as mentioned above, the signal is adjusted. Further circuit elements will likely be needed for filtering, amplification, and / or conversion. Next, the signals generated by the pressure sensors 141 and 142 are processed by the microprocessor 14 It is transmitted to 3. The software embedded / programmed in the microprocessor 143 The software program uses signals generated by sensors 141 and 142 to display LEDs, OLEDs, The screen may be an LCD, touchscreen, or other interactive display unit. The display unit 144 converts the pressure into a (corrected) value that can be visually displayed.

[0058] Figure 15 shows a block diagram of an embodiment of the detection and monitoring system disclosed herein. The input detection device includes an integrated visual indicator 154 and a microprocessor 153 The system also includes an onboard electronics system 150 having pressure sensors 151 and 152. The system is equipped with an inhaler accessory. During use, the system is powered by the user 156 from the battery 155. It is started by the supplied power. When the system is started, the user's inhalation 156 is used. A pressure drop occurs inside the device training device 150, and this pressure drop is measured by the sensor 151. The absolute pressure sensor 152 is used to correct the differential pressure reading for atmospheric conditions. It provides data or signals. In this embodiment, sensors 151 and 152 are digital This is a pressure sensor. When an analog sensor is implemented, as mentioned above, the signal is adjusted. Further circuit elements may be needed for filtering, amplification, and / or conversion. Next, the signals generated by pressure sensors 151 and 152 are processed by microprocessor 1 It is transmitted to 53. The software embedded / programmed into microprocessor 153 The wearer program interprets the signals generated by sensors 151 and 152 as appropriate for inhalation or It can be used to activate a visual indicator 154 that can be used to show other information. Convert to a corrected pressure value.

[0059] Figure 16 further shows a block diagram of an inhaler training device, such as device 10. And further various operational components are shown. In Figure 16, system 160 has two The components of the inhaler training device or accessory equipment 164 and the processing system 166 The processing system 166 is equipped with a tablet, PDA, mobile phone, or computer 1. 67, display unit 168, wireless communication device 169, digital storage device, web interface Includes output 165 which can be in the form of a printout or similar. In this state, the user presses down the power button, for example, button 19 on the training device 10. The inhaler training device 160 can be activated, and the processing system 160 is also activated. When the software program embedded in computer 167 is started, a start signal is sent. The number appears on the display unit 168. When the system is started, the user's inhalation 170 causes the intake A pressure drop occurs within the inhaler training device 160, and this pressure drop is measured by the sensor 161 In this embodiment, sensors 161 and 162 are digital pressure sensors. Next, the signals generated by the color detection sensor 173 and the pressure sensors 161 and 162 are transmitted to the microprocessor 171 and then to the wireless communication device 172. The microprocessor software program incorporated / programmed in the 171 or the computer 167 can be used to convert the signals generated by the color detection sensor 173 and the sensors 161 and 162 into visually displayable cartridge information values and pressure values on a display unit 168 that can be a screen with an LED, OLED, LCD, touch screen, or other interactive display. The cartridge information values provide limitations on powder dosage effectiveness and can be used to plot trapezoid B or other threshold displays on a graph. As referenced in the previous embodiment, in addition to the color detection device, other devices on the device substrate include a laser, RFID, pattern or text / character reader, or sensor connected to the microprocessor and can identify the inhaler, drug, or substance / drug cartridge / package in another way. These sensors / readers function to provide data to the system and microprocessor related to drugs, substances, packaging, dosing, inhalers, etc., and thereby, the corresponding data can be read from the storage device and used as data points on any visual, audible, or other indicator including a graph presented to the user. As an example, a specific cartridge or other package[[ID=,20]] As referenced in the previous embodiment, in addition to the color detection device, other devices on the device substrate include a laser, RFID, pattern or text / character reader, or sensor connected to the microprocessor and can identify the inhaler, drug, or substance / drug cartridge / package in another way. These sensors / readers function to provide data to the system and microprocessor related to drugs, substances, packaging, dosing, inhalers, etc., and thereby, the corresponding data can be read from the storage device and used as data points on any visual, audible, or other indicator including a graph presented to the user. As an example, a specific cartridge or other package character reader, or sensor connected to the microprocessor and can identify the inhaler, drug, or substance / drug cartridge / package in another way. These sensors / readers function to provide data to the system and microprocessor related to drugs, substances, packaging, dosing, inhalers, etc., and thereby, the corresponding data can be read from the storage device and used as data points on any visual, audible, or other indicator including a graph presented to the user. As an example, a specific cartridge or other package character reader, or sensor connected to the microprocessor and can identify the inhaler, drug, or substance / drug cartridge / package in another way. These sensors / readers function to provide data to the system and microprocessor related to drugs, substances, packaging, dosing, inhalers, etc., and thereby, the corresponding data can be read from the storage device and used as data points on any visual, audible, or other indicator including a graph presented to the user. As an example, a specific cartridge or other package including a graph presented to the user. As an example, a specific cartridge or other package The sing can be color-coded, or encrypted or coded text, lock This includes RFID containing specific information about them, such as expiration date and dosage. It can detect codes and use them for calculations, identified actions, and data display. A reader or sensor that can transmit the corresponding data to a microprocessor. Presumably, certain colored packages indicate medication dosages that require greater effort to inhale properly. This indicates the use of the appropriate device or system through the sensor / reader. Identify colors and use appropriate data to provide instructions to the user.

[0060] Figure 17 shows a block diagram of an embodiment of the detection and monitoring system disclosed herein. The input detection device 180 includes a built-in or integrated display unit 184 and a microprocessor 1 83, color detection sensor 187, and pressure sensors 181 (differential pressure) and 182 (absolute pressure) The inhaler accessory is equipped with an onboard electronics system. The system is started by user 186 using power supplied from battery 185. If this occurs, the user's inhalation 186 will cause a pressure drop within the inhaler's accessories, and this pressure drop The pressure below is measured by sensor 181. The absolute pressure sensor 182 reads the differential pressure due to atmospheric conditions. Provides data or signals used to correct the measured value. In this embodiment, S181 and 182 are digital pressure sensors. Next is the color detection sensor 18 The signals generated by 7 and pressure sensors 181 and 182 are processed by the microprocessor 18 It is transmitted to 3. Software embedded / programmed in microprocessor 183 The software program uses the signal-generating color detection sensor 187 and sensors 181 and 18 2. LED, OLED, LCD, touchscreen, or other interactive display Cartridge information that can be visually displayed on the display unit 184, which can be a screen equipped with a display unit. Convert to reported values ​​and (corrected) pressure values.

[0061] Figure 18 shows a block diagram of an embodiment of the detection and monitoring system disclosed herein. The input detection device 190 includes an integrated visual indicator 194 and a microprocessor 193, color detection sensor 197, pressure sensors 191 (differential pressure) and 192 (absolute pressure) The inhaler accessory is equipped with an onboard electronics system that has the following features. At that time, it is started by user 196 using power supplied from battery 195. The system starts. If this occurs, the user's inhalation 196 will cause a pressure drop within the inhaler attachment, and this pressure The drop is measured by sensor 191. The absolute pressure sensor 192 measures the differential pressure due to atmospheric conditions. Provides data or signals used to correct readings. Sensors 191 and 192 are digital pressure sensors. Next is color detection sensor 1 The signals generated by 97 and pressure sensors 191 and 192 are processed by microprocessor 1 It is transmitted to 93. The software embedded / programmed into microprocessor 193. The wear program uses the color detection sensor 197 and sensors 191 and 1 to generate signals. Each of the 92s is a visual indicator that can be used to show proper inhalation or other information. Convert to cartridge information values ​​and (corrected) pressure values ​​that can be used to activate 194. do.

[0062] FIG. 19 shows a flowchart diagram of an embodiment of a method 200 for detecting, monitoring, and training an inhaled subject by the system disclosed in FIG. 16. When a user uses the device and system, the system is activated by depressing an actuator on the inhaler accessory device to start. Next, in step 202, the wireless communicator of the inhaler accessory device connects to the user's smartphone, for example, using standard Bluetooth (registered trademark) technology, and an application on the smartphone displays a ready message and instructs the user to load the associated inhaler that the device is engaged with or to supply a cartridge of the substance inhaled into the inhaler or other disposable package. In step 204, after such loading, an identification sensor, in this case a color detection sensor 173, determines the color of the cartridge and stores it in the data storage device on the accessory device substrate or transmits it via Bluetooth (registered trademark) to the processing system 166 (phone) for storage. In step 206, the application displays a graph at the corresponding threshold data points provided based on the color detection. Next, in step 208, the user is instructed to inhale using some visual, audible, or screen-based messages. In step 210, during the inhalation operation, sensors 161, 162 read the pressure drop. Next, step 212 shows a correction step performed by the system based on the atmospheric conditions that occur simultaneously with or immediately after step 210. In any case, in step 214, the pressure data is stored as described above and preferably plotted on a graph. In step 216, the inhalation operation graph is analyzed to determine if the inhalation is correct. If the inhalation is incorrect, the user is provided with feedback in step 218. In step 220, the system determines if the training session is complete. If the training session is not complete, the process returns to step 208. If the training session is complete, the system ends in step 222. is analyzed to determine if the inhalation is correct. If the inhalation is incorrect, the user is provided with feedback in step 218. In step 220, the system determines if the training session is complete. If the training session is not complete, the process returns to step 208. If the training session is complete, the system ends in step 222. is analyzed to determine if the inhalation is correct. If the inhalation is incorrect, the user is provided with feedback in step 218. In step 220, the system determines if the training session is complete. If the training session is not complete, the process returns to step 208. If the training session is complete, the system ends in step 222. is analyzed to determine if the inhalation is correct. If the inhalation is incorrect, the user is provided with feedback in step 218. In step 220, the system determines if the training session is complete. If the training session is not complete, the process returns to step 208. If the training session is complete, the system ends in step 222. is analyzed to determine if the inhalation is correct. If the inhalation is incorrect, the user is provided with feedback in step 218. In step 220, the system determines if the training session is complete. If the training session is not complete, the process returns to step 208. If the training session is complete, the system ends in step 222. is analyzed to determine if the inhalation is correct. If the inhalation is incorrect, the user is provided with feedback in step 218. In step 220, the system determines if the training session is complete. If the training session is not complete, the process returns to step 208. If the training session is complete, the system ends in step 222. is analyzed to determine if the inhalation is correct. If the inhalation is incorrect, the user is provided with feedback in step 218. In step 220, the system determines if the training session is complete. If the training session is not complete, the process returns to step 208. If the training session is complete, the system ends in step 222. is analyzed to determine if the inhalation is correct. If the inhalation is incorrect, the user is provided with feedback in step 218. In step 220, the system determines if the training session is complete. If the training session is not complete, the process returns to step 208. If the training session is complete, the system ends in step 222. is analyzed to determine if the inhalation is correct. If the inhalation is incorrect, the user is provided with feedback in step 218. In step 220, the system determines if the training session is complete. If the training session is not complete, the process returns to step 208. If the training session is complete, the system ends in step 222. is analyzed to determine if the inhalation is correct. If the inhalation is incorrect, the user is provided with feedback in step 218. In step 220, the system determines if the training session is complete. If the training session is not complete, the process returns to step 208. If the training session is complete, the system ends in step 222. is analyzed to determine if the inhalation is correct. If the inhalation is incorrect, the user is provided with feedback in step 218. In step 220, the system determines if the training session is complete. If the training session is not complete, the process returns to step 208. If the training session is complete, the system ends in step 222. is analyzed to determine if the inhalation is correct. If the inhalation is incorrect, the user is provided with feedback in step 218. In step 220, the system determines if the training session is complete. If the training session is not complete, the process returns to step 208. If the training session is complete, the system ends in step 222. is analyzed to determine if the inhalation is correct. If the inhalation is incorrect, the user is provided with feedback in step 218. In step 220, the system determines if the training session is complete. If the training session is not complete, the process returns to step 208. If the training session is complete, the system ends in step 222. is analyzed to determine if the inhalation is correct. If the inhalation is incorrect, the user is provided with feedback in step 218. In step 220, the system determines if the training session is complete. If the training session is not complete, the process returns to step 208. If the training session is complete, the system ends in step 222. is analyzed to determine if the inhalation is correct. If the inhalation is incorrect, the user is provided with feedback in step 218. In step 220, the system determines if the training session is complete. If the training session is not complete, the process returns to step 208. If the training session is complete, the system ends in step 222. is analyzed to determine if the inhalation is correct. If the inhalation is incorrect, the user is provided with feedback in step 218. In step 220, the system determines if the training session is complete. If the training session is not complete, the process returns to step 208. If the training session is complete, the system ends in step 222. is analyzed to determine if the inhalation is correct. If the inhalation is incorrect, the user is provided with feedback in step 218. In step 220, the system determines if the training session is complete. If the training session is not complete, the process returns to step 208. If the training session is complete, the system ends in step 222. is analyzed to determine if the inhalation is correct. If the inhalation is incorrect, the user is provided with feedback in step 218. In step 220, the system determines if the training session is complete. If the training session is not complete, the process returns to step 208. If the training session is complete, the system ends in step 222. The "F" is accompanied by a threshold graph that shows either a pass (successful inhalation) or a fail (failed inhalation). This message is displayed to the user. At that point, the user presses down the actuator to terminate the program. This can be done, and the data remains stored in output 165 for future use.

[0063] In some exemplary embodiments disclosed herein, the total inhalation time, peak inhalation pressure, This includes the time to reach the peak inhalation pressure, and the average pressure from the peak to approximately 75% of the total inhalation time. One or more key parameters can define acceptable inhalation operations. In this embodiment, the total inhalation time may exceed 5 seconds, and the peak differential inhalation pressure may exceed approximately 6 kPa. In some cases, the time to the peak inspiratory pressure may be less than approximately 1.1 seconds, and the peak difference The average pressure from inhalation to 75% of the total inhalation time is approximately 4 kPa. These values ​​are used for inhalation monitoring. Vision systems 10, 12 and equipment 18, as well as related equipment used for training and monitoring. These represent values ​​for the algorithm / program. They are alternative inhaler training devices. Depending on the performance parameters (including resistance) required for optimal drug delivery by the inhaler, It can be corrected.

[0064] In another exemplary embodiment, the dry powder inhaler is provided with a detection and / or monitoring device. This detection and / or monitoring device can detect dry powder inhalation during the patient's inhalation procedure. Monitor and / or detect signals generated by the inlet or generated within the dry powder inhaler. It is possible. The dry powder inhaler is integrated into the device or attached to the device. A sensor device can be provided. Alternatively, in one exemplary embodiment, an accessory device 1 8, 24, if necessary, the integrated part of the dry powder inhaler into the mouthpiece or housing. It can be established as such.

[0065] In an alternative embodiment, the inhaler attachments 18 and 24 can be detached from the inhaler. And, provided in the form of a jacket or cap, attachable / removable detection The monitoring device, a removable detection and monitoring device, 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, thereby allowing the device to be used The subject can access and move more easily. In this embodiment, the jacket is One or more microprocessors, wireless transceivers, analog-to-digital converters, sensors A separate, portable onboard electronic device (including pressure sensors or microphones, etc.) It is manufactured as a removable device, capable of detecting signals, storing signals, transmitting signals, and It can be displayed.

[0066] When using an acoustic sensor, the inhaler may or may not contain dry powder during use. The sound waves are detected by a microphone, the signal is analyzed, and the type of sensor used is determined. Depending on the type, if dry powder is present, the powder discharge time, airflow rate, and powder discharge during the suction operation are as follows: The end of the process can be correlated with the temperature in the inhaler's pathway, etc. For example, an increase in sound may be related to the device. Correlating with the flow rate through the location and / or the increase in collisions of powder particles in the airflow during delivery. It is possible to do so.

[0067] Microphones and other sensors are small in size, which means they can be placed anywhere inside the inhaler. However, it can be placed. In an embodiment where the sensor is a pressure transducer, the sensor is located in the small chamber of the inhaler. It can be placed inside an air conduit through one of the tubes. The sensor can be placed, for example, on an inhaler or inhaler. A cap that can be installed in the air conduit inside the device, or that can be fitted to or attached to the inhaler. The inhaler must be compatible with a jacket, sleeve, or saddle-like structure. A separate, removable accessory for an inhaler having a shape or configuration that can be fitted to the inhaler. It can be provided as a possible part.

[0068] In the case of a removable embodiment, the detection and monitoring accessory is easy and inexpensive to manufacture, and plastic It can be made from stick and works well with high-resistance dry powder inhalers. In this embodiment, this sensor is any sensor, for example, a thermocouple wire, a pressure transducer, an analog Signals generated within a gas sensor, microphone, light sensor, gas sensor, or inhaler Any detectable sensor can be used. The sensors described herein are transceiver devices. It may be adapted to transmit or transmit a signal, or the signal may be adapted to transmit this signal Before transmission to the microprocessor, transmission is performed using a wired connection to an analog-to-digital converter. Alternatively, it may be possible to remember it.

[0069] Alternatively, an analog-to-digital converter may be installed within the inhaler device, and the resulting digital data The signal is transmitted directly from this device. The signal provided by the sensor described herein is , the airflow passing through the air conduit, and / or the collision of powder particles carried along the airflow path, and pressure drops detected in the vicinity of the airflow path for inhalation operation are generated in the inhaler. It can take several forms, including the sound produced. The signal generated from the inhaler is It can be detected by the sensor, stored, transmitted, or displayed. The types of signals are text, color, encryption, or code, and they are preferably electronic. Integrated into the substrate, it detects light beams, laser beams, and Doppler sensors. This can be done. The data can be generated from the signal and analyzed qualitatively and / or quantitatively. This method allows for analysis of factors such as dosage release time, dosage, type of administration, and administration time. It can generate measurements that include, for example, patient, drug It can be associated with the type of substance and dosage, inhaler, or other identification, and appropriate inhalation Modeling the data requirements for input and using them to facilitate training of inhaler users. It is possible.

[0070] In one exemplary embodiment, a detection and monitoring system for an inhaler is adapted to the inhaler. These are structurally configured auxiliary devices, such as sensors, microprocessors, and any analogs. Includes a log-to-digital converter and a data storage medium. The data storage medium is a disk drive. DVDs, CD-ROMs, servers, flash cards or drives, memory cards, etc. This includes and is executed by a microprocessor or other processing unit that executes algorithms. It includes a set of machine-readable instructions. At runtime, the algorithm detects Steps to generate a logical subsystem generation number obtained from the signal, and the logical subsystem generation A step of storing a substitute number in a data track within a logical subsystem, the logical subsystem Steps and algorithms are used to compare the stem generation number and the cluster generation number of the processing unit. The steps include storing and / or displaying information from the Zoom as a result of the inhalation operation. Let's begin.

[0071] In certain embodiments, the inhaler accessory is useful for dry powder inhalers, particularly for unit doses. Useful in dosage cartridges, drug delivery formulations include, for example, diketopiperazine, in particular , fumaryldiketopiperazine and endocrine hormones (parathyroid hormone, insulin) Peptides containing oxytomodulin and glucagon-like peptide 1 Active components such as proteins, cannabinoids, 5-hydroxytryptamine, dopamine Neuroactive agents, including prostacyclins, opioid agonists, and antagonists. It contains a neurotransmitter. In some embodiments, the active ingredient of the prescription drug is one of the active agents. Or including more than one, it is treprostinil, salmeterol, epinephrine, tacrolite. Limus, vancomycin, linezolid, filgastrin, fentanyl, cannabidio THC, palonosetron, amphotericin B, phosphodiesterase inhibitors (sil Denafil, avanafil, verdenafil, and tadalaf (Including PDE5 inhibitors such as IV), prostaglandins, prostacyclins, and neurotransmitters Transmitter agonists, neurotransmitter antagonists (including antinociceptive drugs), opioids Analgesics (for example, delta opioid agonists and antagonists, kappa opioid) Opioid receptor agonists and antagonists, mu-opioid receptor agonists and This includes, but is not limited to, antagonists. [Examples]

[0072] Example 1: Use of a built-in training device A 60-year-old patient with type 1 diabetes has elevated and uncontrolled hemoglobin A1c levels. Therefore, for dietary therapy, an insulin supplied from a dry powder inhalation system The patient was instructed to receive phosphorus inhalation. The patient received insulin for basal insulin. Use the device. The patient has a removable inhalation attachment as shown in Figures 3-5. The patient received training in wireless inhalation using a device as shown in Figure 1. Deep, rapid breathing when using a training device that may or may not contain drugs. I was asked to do it.

[0073] A pressure sensor on the inhalation device is used to detect pressure drops during inhalation, and the data is related to The application transmits data to a Bluetooth®-enabled tablet. The color detection sensor detects the color of the cartridge (filled or empty) and the data This was used to identify the threshold region for the minimum suction pressure. The data was taken from the instrument. A tablet with a programmed application that can read wireless signals. The data was collected above, and patients could view this data in real time on a display screen. The patient's initial inhalation attempt was too late, resulting in the red "unacceptable area" (area B) in Figure 12. The screen indicated that the patient was in the (area). The patient was asked to proceed slightly faster and deeper than in the previous trial. He was instructed to take another quick breath. Once the inhalation was complete, the graph showed the patient's inhalation technique. The work is acceptable and is entirely within the acceptable region (region C) of the graph in Figure 12. As demonstrated, once the patient becomes accustomed to the training, they will be able to use similar inhalation devices in which the drug is loaded. He was there and understood it well.

[0074] The patient uses a dry powder inhaler similar to the type shown in Figure 1, and the patient uses it to treat their diabetes. They are prescribed cartridges filled with inhalable insulin in various dosages. Six months after being prescribed insulin inhalation, this patient's diabetes was under control. He was diagnosed with [the condition].

[0075] Example 2: Use of a mountable training device A 59-year-old patient with type 2 diabetes receives insulin inhalation from a dry powder inhalation system. The patient was instructed to do so. The patient requested an inhalation system for convenience. The patient, The patient received training in wireless inhalation using a device as shown in Figure 1. The patient then performed the inhalation shown in Figures 3-5. The device shown in Figure 1, which is equipped with an inhaler device that can be attached to the same equipment as the medical equipment, is provided with this training equipment I was instructed to breathe deeply and quickly when using the device.

[0076] Pressure and color recognition data are collected on the mobile phone, and the patient can view the data on the display screen. It could be seen in real time. This patient's first attempt was shown in the graph, or Another method, visually represented as a result of the software, is shown by threshold vs. inhalation data. As expected, it was acceptable. Once the patient became accustomed to the training, they were able to use the device. I knew it all along.

[0077] The sensor that could be attached to the patient was removed from the dry powder inhaler. The patient received the dry powder Inhaler and cart filled with inhalable insulin for treating the patient's diabetes. Ridge was given. Six months after being prescribed inhaled insulin, this patient's diabetes was controlled. Diagnosed with trolling, this patient commented that this device is very convenient. did.

[0078] The foregoing disclosures are illustrative embodiments. The techniques disclosed herein are the same as those described herein. This will reveal representative techniques that work well in practice, according to those skilled in the art. It should be understood. However, as a person skilled in the art will see in light of this disclosure, many changes are disclosed. This is done in a particular embodiment and does not deviate from the spirit and scope of this disclosure. It should be understood that similar or comparable results can be obtained further.

[0079] Unless otherwise specified, molecular weights and reaction strips used in the specification and claims All numbers expressing the quantity and characteristics of components such as "items" and "others" are, in all cases, "approximately". It should be understood as something that is modified by the term "(about)". Conversely, unless otherwise indicated, the numerical values ​​described in the specification and the attached claims are not applicable. The parameters are approximations that may vary depending on the desired characteristics to be obtained. However, this is not an attempt to limit the application of the doctrine of equivalents to the scope of the patent claims, but rather an attempt to limit the application of each numerical part Lameta applied standard rounding techniques, taking into account at least the reported number of significant figures. It should be interpreted as such. A number describing the broad scope of the disclosed embodiments. Despite the range of values ​​and parameters being approximations, the numbers given in the specific examples are, It will be reported as accurately as possible. However, each of these values ​​is related to the individual test measurements. The resulting standard deviation inherently contains a certain degree of error.

[0080] In the context of describing the disclosed embodiments (in particular, in the context of the appended claims) The terms used are "one, one, a (a, an)", "the aforementioned, this, that ( Unless otherwise specified herein, the pronouns "the" and similar demonstrative pronouns also Unless explicitly stated otherwise by the context, it is interpreted as encompassing both singular and plural forms. It should be done. The range of values ​​described herein refers to each individual value that falls within that range. It is merely intended to serve as a shorthand notation for referring to each of them individually. Unless otherwise specified, each individual value is listed separately in this specification. It is incorporated herein as if it were. All methods described herein are incorporated herein Unless otherwise specifically indicated, or unless clearly negated by the context They can be performed in any appropriate order. Any and all given herein The use of examples or illustrative phrases (for example, "such as") This is merely intended to better illustrate the disclosed embodiments, and not to show any other way. This does not limit the scope of the embodiments claimed herein. The rotation also does not include any unclaimed elements that are essential to the implementation of the disclosed and intended embodiments. It should not be interpreted as indicating something.

[0081] The specific embodiments disclosed herein consist of ", or "consisting essential The claims may be further limited by using the phrase "y of)". The transitional phrase "consisting of" means that whether it is when the application is filed or as a supplement Whether added to each positive, when used in the claims, claims Exclude any element, step, or component not specified within the scope. Transition clause "Consisting essentially of" is, The scope of the search term substantially reflects the specific materials or steps, and the basic and novel features. The claims are limited to those that do not have an effect. Embodiments claimed in this manner are not essential or obvious. This is explicitly described herein and made possible.

[0082] Any grouping of alternative elements or embodiments disclosed herein should be construed as limitations. There is no such thing. Each group component may be referenced or claimed individually, or other components of the group. The components may be any combination of the components or other elements found herein. One or more components are included in the group for convenience and / or patentability or group It is expected that it may be removed from. Any such inclusion or removal may occur. In that case, this specification includes the modified version and, therefore, the appended claims. It is considered to satisfy the description requirements of all Markush groups used in this context.

[0083] Specific embodiments are disclosed and intended for the authors of this disclosure to carry out the intended embodiments. This specification includes known best modes. Of course, these described practices The changes in form will become clear to those skilled in the art upon reading the above explanation. The author states that those skilled in the art will understand that The authors anticipate using such forms of modification as needed, and this is disclosed and intended. The embodiments described herein are intended to be carried out in a manner other than those specifically described herein. Therefore, the embodiments disclosed and intended herein are permitted by applicable law. Furthermore, all modifications of the subject matter set forth in the claims attached to this specification and Including equivalents. Furthermore, any combination of the above elements in all possible forms of modification. Unless otherwise specified herein, or as clearly indicated by the context, Unless otherwise denied, this is included in this disclosure.

[0084] Furthermore, numerous references are made to patents and publications throughout this specification. Each of the above-mentioned references and publications, individually or in whole, is referred to herein by reference. It will be incorporated into it.

[0085] Finally, the embodiments disclosed and intended herein illustrate the principles of the conceived invention. It should be understood that this is the case. Other modifications that may be used are within the scope of this disclosure. There are alternative configurations, as examples and not limited to them, according to the teachings herein. It may be used in this way. Therefore, the disclosed embodiments are illustrated and described in this way. It is not limited to things that are exactly as described.

Claims

1. Inhaler accessory device, A main unit that is attached to or connected to an inhaler, Microprocessor and A color detection sensor for detecting drug data encrypted or coded by the color of one area or part of the inhaler, An absolute pressure sensor that measures external atmospheric pressure and generates at least one signal, A differential pressure sensor that detects the pressure drop inside the inhaler and generates at least one signal, Equipped with, Each signal is processed by the microprocessor and becomes a microprocessor output, and at least one signal generated by the differential pressure sensor is calibrated, if necessary, by at least one signal generated by the absolute pressure sensor. The microprocessor output generates a pressure-time curve, along with a threshold profile corresponding to the drug data, on a display device simultaneously with or immediately after the user's inhalation operation.

2. The inhaler accessory device according to claim 1, wherein the absolute pressure sensor and the differential pressure sensor are digital sensors and their outputs are in digital format.

3. The inhaler accessory device according to claim 2, further comprising a wireless transceiver for transmitting data received from the absolute pressure sensor and the differential pressure sensor to a remote processing system.

4. The inhaler accessory device according to claim 3, further comprising an electronic circuit board, wherein the microprocessor, the absolute pressure sensor, the differential pressure sensor, and the wireless transceiver are connected to and / or disposed on the electronic circuit board.

5. The inhaler accessory device according to claim 1, further comprising a visual indicator or display unit on the display device for indicating success / failure to the user.

6. The inhaler accessory according to claim 5, wherein the visual indicator shows the user that an appropriate dosage is being provided in accordance with a predetermined preferred inhaler operation.

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

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

9. The inhaler accessory according to claim 8, wherein the at least one active ingredient comprises insulin or an insulin analog.

10. The inhaler accessory device according to claim 1, wherein the microprocessor output includes threshold data.

11. The inhaler accessory according to claim 1, wherein the pressure-time curve is an inhalation effort-time curve.

12. Furthermore, the inhaler accessory device according to claim 1, including a battery.

13. A method for monitoring and detecting accurate data of value for user training of dry inhalers, A step of displaying instructions to load the drug into the inhaler, A step of reading drug data relating to the drug or the inhaler, which is encrypted or coded by the color of one area or part of the inhaler, using a non-contact identification sensor. A step of identifying absolute pressure data using an absolute pressure sensor that acquires external atmospheric pressure, Steps to calibrate atmospheric conditions, A step of displaying instructions to start the inhalation procedure, A step of detecting the pressure drop measured in the inhalation path of the dry inhaler during inhalation by the user, using a differential pressure sensor calibrated for absolute pressure data under the aforementioned atmospheric conditions, and acquiring pressure difference data. A step of relating the drug data and the pressure difference data to calculate the minimum inhalation effort threshold at which the user should effectively inhale the drug. A step of determining whether the user succeeded or failed in the inhalation procedure based on the calculated threshold, and A method comprising the step of displaying the inhalation effort along the threshold corresponding to the drug data as an inhalation effort versus time curve, wherein the inhalation effort takes into account differential pressure data calibrated by the absolute pressure data.

14. The method according to claim 13, further comprising the step of transmitting an instruction on whether the user's inhalation profile fits, does not reach, or exceeds the calculated threshold.

15. The method according to claim 14, wherein the transmission step includes transmitting for display on a remote processing system such as a smartphone, tablet, computer, or other wireless communication-enabled device.

16. The method according to claim 15, wherein the transmission step includes transmitting the drug data and the pressure difference data to the remote processing system via wireless transmission.

17. The method according to claim 16, wherein the remote processing system includes the step of providing an application that displays an inhalation effort versus time curve, along with thresholds corresponding to the drug data.

18. Furthermore, the method according to claim 17, which provides an application for storing detected information and differential pressure data.

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