Apparatus, system and method for detecting and monitoring inhalations

Abstract

To provide an inhaler accessory apparatus and method for sensing and measuring real-time characteristic patterns of a subject's use of a dry powder inhalation system.SOLUTION: An inhaler device can be used in a wireless communication mode to communicate with a display to assess the subject's usage of the inhalation system concurrently with the inhalation, and thus, the subject's inhalation and the performance of the inhalation system can be evaluated. The system can also detect the identity of the medicament, its dosage, lot, expiration, etc. and the characteristic profile of a dry powder formulation emitted from the inhalation system in use, and allows effective delivery of powder doses. Data obtained can be transmitted to a digital application and can be analyzed for optimal therapeutic utility.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is the benefit of U.S. Provisional Patent Application No. 62 / 662,051, filed April 24, 2018. The benefit of this application is claimed and the entire contents of which are incorporated herein by reference.

[0002] The present specification includes a method for detecting the presence of a reactive oxygen species (ROI) generated by an inhaler and / or a subject during an inhalation operation. for recording, transmitting, and displaying physical measurements based on real-time physiological conditions An interactive device and method are described. [Background technology]

[0003] For dispensing therapeutic substances via the respiratory tract, particularly for the treatment of local or systemic diseases Inhalers for pulmonary delivery in the pulmonary ... Dry powder inhalers and dry powder inhalers are used to treat asthma, respiratory tract infections, and systemic diseases such as diabetes. It has been used to treat diseases such as urinary tract infections.

[0004] In the treatment of disease, the efficiency of delivering the required dosage of therapeutic substance to the patient depends on the efficiency of the device. and overall efficiency depends on the amount of time spent using the device, for example to teach patients proper inhalation technique. , enhanced by providing appropriate feedback mechanisms to the patient, clinician, or physician. Improper use of the device and poor inhalation technique can lead to a lack of effectiveness in treating the disease. For example, administering a lower or higher dosage of a therapeutic substance than intended may To effectively deliver a therapeutic substance to the airways, the patient or user must: They may be trained or instructed in the proper use of the equipment.

[0005] Dry powder inhalers, used to deliver medicine to the lungs, typically contain a single dose of powder. The powdered formulation is delivered in bulk or in hard gelatin capsules, cartridges, or blisters. Quantified into individual multiple doses stored in unit dose compartments such as packs Dosing reproducibility is the consistency and reproducibility of the formulation. Therefore, dosing requires that the dose can be delivered to the patient with a certain result. This can be improved by optimizing the release of the drug, for example, to provide the patient with the necessary dosage. This is achieved by having the patient perform an appropriate inhalation maneuver.

[0006] The patient is then placed in a pulmonary tract to ensure proper delivery of the therapeutic agent. Equipment for training a person is described, for example, in U.S. Pat. No. 5,333,106. This paper uses the proper sequence of inhalation steps and is based on airflow versus volume data. Interactively train patients to use aerosol inhalers that include a feedback display. No. 10 / 759,859 (U.S. Pat. Appl. No. 10 / 759,859) discloses an apparatus for kneading a granular material. In the specification of the published patent application No. 2004 / 0187869, a drug inhaler, for example, a dry powder A training device for a hooder inhaler is disclosed, which measures the pressure difference and A dry powder inhaler simulator was used to assess both the speed of inhalation and peak inhalation flow rate. It is based on displaying a single value corresponding to the

[0007] U.S. Patent Nos. 8,499,757 and 8,636,001 (dry The disclosures of which are incorporated herein in their entirety for all that they teach regarding powder inhalers. Dry powder inhaler and cartridge systems, such as those described in by deagglomerating the powder formulation in the inhaler and capsule or cartridge, During the inhalation maneuver, primary drug particles or a suitable plume of inhaled smoke may be generated. The benefits of delivery are many, including rapid entry into the arterial circulation, initial hepatic metabolism, and Avoidance of drug degradation during transit and ease of use compared to other routes of administration, e.g., injection These devices have been used in clinical settings and are currently is commercially available.

[0008] An interactive device and method for profiling inhalation effort is disclosed in U.S. Pat. No. 9,364, No. 619, the disclosure of which is incorporated herein by reference. Summary of the Invention [Problem to be solved by the invention]

[0009] There are many techniques in the art that aim to maximize accuracy and proper use of inhalation systems. Minimal training and effort is required for the use of the inhalation system and for Improvements to the design and manufacture of inhalers to monitor patients throughout the entire care chain, and of inhalers and inhaler parts, including the reusability of packaging and the entire system. Improvements in application flexibility are needed. The present disclosure provides a system that achieves these goals. and methods are presented. [Means for solving the problem]

[0010] The present invention provides a method for detecting and measuring intake characteristic parameters of an inhalation system in use. an interactive device including an inhaler and a patient's method of using the inhaler in conjunction with the device; In disclosed embodiments, the device and method of using the device may, for example, In sensing, detecting, measuring and monitoring a characteristic inhalation profile or breathing pattern, To collect data generated from the subject's inhalation maneuver and use it in treatment planning. the effort required to deliver an adequate dose or therapeutic dose using the inhaler provided to the subject The devices and methods may also be useful, for example, to allow a subject to appropriately identify the medication being delivered. an inhalation device for effectively treating a disease, disorder, or condition in a subject, so that the subject receives an appropriate dose of In one embodiment, the present invention is useful for training / teaching a subject to use The device delivers one or more active pharmaceutical ingredients or drugs to the lungs, and therefore the pulmonary circulation and Any inhaler, particularly a high resistance dry powder inhaler, may be included for delivery to the systemic circulation. In some embodiments, the dry powder inhaler is breath-actuated and administered by the patient. When used, the patient can observe the degree of effort during inhalation, which is indicative of the actual effort being exerted. It appears as soon as you inhale.

[0011] Exemplary embodiments of the inhalation devices and systems disclosed herein are separate devices. an inhaler attachment device; the inhaler attachment device is compatible with or attachable to the inhaler, so that It may be in close contact with or attached to the inhaler during use and removed from the inhaler after use. It is possible.

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

[0013] In some embodiments, an inhaler accessory device is provided for coupling to the subject's inhaler. and; activating the inhaler attachment system; and while the subject is inhaling, The device monitors inhalation by the subject and ensures effective delivery of the therapy to the respiratory system. Facilitates training and / or monitoring of subjects to achieve an optimal or appropriate inspiratory maneuver for The method includes detecting and monitoring the drug delivery system, and determining whether the drug delivery system is optimal. Therefore, appropriate adjustment of the inhaler should be performed to achieve the preferred flow profile for that individual. The devices and methods also facilitate training of subjects on proper use, e.g., dose during delivery; Quantification of the drug being delivered, duration of dose release during delivery; number of doses administered to the subject; to monitor the performance of the inhalation system provided to the patient, as well as in real time to monitor the mechanical integrity of the inhalation system at the time of the procedure and / or to provide data for future analysis. In some embodiments, the inhaler accessory device may be used to store the inhaler accessory data. The inhaler or parts of the inhaler (such as cartridges) that may be used may be provided with a code or identifier. , including radio frequency identification (RFID), color coding, laser etching, text, etc. obtain.

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

[0015] In one exemplary embodiment, the device is a microfluidic device, such as that described in U.S. Pat. No. 7,305,986 and U.S. Pat. No. 6,305,986. and 7,464,706, U.S. Pat. No. 8,499,757; U.S. Pat. No. 8, Nos. 424,518 and 8,636,001 (dry powder inhalers) (all disclosures of which are hereby incorporated by reference in their entirety). The device may be adapted to a high resistance dry powder inhalation system such as that described in Dry powder inhalers, with or without cartridges containing pharmaceutical formulations, electrical, electronic, One or more transducers, including electromechanical, electromagnetic, photonic, or photovoltaic; e.g., pressure Force sensors, temperature sensors, sound sensors, and optical sensors; signal conditioning circuits and / or It may include a software program, a means for electronic signal communication, and an output display. In such exemplary embodiments, the device may include analog or digital sensors, amplifiers, and sensors. Suitable signal conditioning, such as filtering or analog-to-digital conversion, and on-board processing microprocessor, and a remote computer or tablet for subsequent signal processing. wireless communication devices that communicate with mobile phones, personal digital assistants (PDAs), and / or real-time The device may be used in conjunction with a digital output display. for delivering a pharmaceutical composition contained in a pre-metered unit dose cartridge containing In alternative exemplary embodiments, the sensing and monitoring equipment may be empty or A dry powder inhaler including a cartridge that can contain a dry powder suitable for pulmonary delivery. The present invention may be adapted for use on or within an inhalation system including:

[0016] In one embodiment, the inhaler accessory device is configured to: attach to or connect to an inhaler; a microprocessor and at least two pressure sensors, e.g. a first pressure sensor for detecting encrypted or coded information in an area or portion of the inhaler; a force sensor; and a second pressure sensor for detecting a signal generated by the inhaler during use. and optionally a pressure equalization channel between the first pressure sensor and the second pressure sensor. and a pressure sensor for detecting a pressure difference between the first pressure sensor and the second pressure sensor. Each signal is processed by the microprocessor to produce a customized The microprocessor output is then adjusted to the user's Upon completion of the inhalation maneuver, the device generates a pass or fail indication. The device accessory generates a graphical representation of the pressure versus time curve characteristic of the inhalation maneuver performed by the user. and align user performance with a predetermined ideal profile for inhaler type. Includes a microprocessor that compares the values ​​to a graph.

[0017] In another embodiment, the inhaler accessory device includes a first pressure sensor and a second pressure sensor. These are digital sensors and their output is in digital form. In an embodiment, the inhaler accessory device is configured such that the second pressure sensor is an analog sensor. The output is in analog form, and the device further includes the functions of conditioning, filtering, and It may contain additional circuitry for filtering, amplifying and / or converting to digital form. The second pressure sensor can detect a pressure drop measured within the flow path in the inhaler, and In some embodiments, the inhaler accessory further includes a sound sensor. A sound sensor that detects an acoustic signal, including the amplitude of the signal, the frequency of the audio signal, or a combination thereof. In an alternative embodiment, the inhaler may include a sound sensor, and the sound sensor is a microphone. The device detects color within multiple portions of an inhaler, inhaler cartridge, or other medication packaging. a laser beam, a Doppler sensor, an infrared sensor, sensor or other sensing beam.

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

[0019] The inhaler accessory device may further comprise an inhaler cartridge or other drug package inserted into the inhaler. a color detection sensor for detecting the color of the medicine, a cartridge or other medicine inserted in an inhaler An RFID reader for reading the RFID tag inside the package, and an inhaler or or letters, codes or text provided on an inhaler cartridge or other drug packaging In some embodiments, the sensor includes one or more image detection sensors capable of identifying information. The inhaler accessory device further comprises: a remote control configured to receive data from the at least two sensors; The inhaler accessory device also includes a wireless transceiver that transmits the information to a processing system. board (microprocessor, sensors and radio transceivers are connected to the electronic board and / or placed on an electronic board), and a visible indicator or pass / fail In some embodiments, the microprocessor may include a display for displaying an indication. , including customized threshold data for the signal produced by the first pressure sensor. It may have a customized microprocessor output and may also synchronize with the patient's inhalation. It may have an output that generates a pressure versus time curve on a display at the same time or immediately thereafter. In an embodiment, the inhaler accessory device may comprise, for example, multiple portions of an inhaler, a capsule, and a cartridge. Statistical algorithms, including color classification algorithms for color-coded object detection, including color-coded objects. Using an algorithm, these colors are differentiated by capsule / cartridge type and color. This information is used to correlate with the strength of the dose provided by the drug.

[0020] In an alternative embodiment, the dry powder inhalation monitoring and detection system comprises a dry powder inhalation the inhaler; the microprocessor, the radio transceiver, and the dark area or portion of the inhaler. a first pressure sensor for detecting the encoded or coded information; and an inhaler device when in use. a second sensor that detects the signal generated from the first sensor and communicates with the first sensor through a pressure equalization channel; each of the first and second pressure sensors comprising at least one The signal is processed by the microprocessor to generate a customized The microprocessor output is a signal that corresponds to the user's inhalation operation. Once the operation is complete, a pass or fail indication is generated. The inhalation monitoring and detection system further includes a display, a wireless transceiver, and a first a threshold value corresponding to the pressure sensor information of the first pressure sensor, and a user inhalation data corresponding to the second pressure sensor; The display shall provide a graphical report of pass or fail indication, including showing the data. and a microprocessor configured to execute the processing.

[0021] Dry powders containing microparticles suitable for pulmonary delivery are described, for example, in U.S. Pat. No. 8,499,777. 57 and 8,636,001 (all of which disclose fine particles) The disclosures of which are incorporated herein by reference in their entireties. In each exemplary embodiment, the dry powder, the active ingredient, Molecules include proteins, peptides, or polypeptides, and combinations thereof, e.g., Secretory hormones, such as insulin, glucagon-like peptide 1 (GLP-1), and parathyroid glands It may be a hormone or an analog thereof.

[0022] In some embodiments, the dry powder formulation for delivery to the pulmonary circulation comprises a peptide, Active ingredients or active agents include proteins, hormones, their analogs, or combinations thereof The active ingredients are insulin, calcitonin, growth hormone, treprostinil, and Lonosetron, tobramycin, filgastrin, erythropoietin Poietin, granulocyte-macrophage colony-stimulating factor (GM-CSF), chorionic gonadotropin Lutein-releasing factor, luteinizing-releasing hormone, follicle-stimulating hormone (FSH), vasoactive intestinal Peptides, parathyroid hormones (including black bear PTH), parathyroid hormone-related proteins Protein, glucagon-like peptide-1 (GLP-1), exendin, Lamulintide, oxyntomodulin, peptide YY, deoxyribonuclease 1, ibuprofen Interleukin 2-inducible tyrosine kinase, Bruton's tyrosine kinase (BTK), inositol-requiring kinase 1 (IRE1), or its analogs, a PC-DAC-modified derivative or its O-glycosylated form, an epitope, In certain embodiments, the pharmaceutical composition or dry powder comprises nephrin, an antibacterial agent, or an antifungal agent. The drug product contains fumaryl diketopiperazine, and the active ingredients are insulin, parathyroid gland hormone 1-34, GLP-1, oxyntomodulin, peptide YY, heparin, epithelium somatic hormone releasing peptide (PTHrP), neurotransmitter agonists and antagonists, e.g., 5 -Hydroxytryptamine receptor agonists and antagonists, prostacyclin i.e. PGI 2. One or more selected from epinephrine, norepinephrine, and analogs thereof.

[0023] In one exemplary embodiment described herein, the device comprises a dry powder inhaler and the sensor communicating with the pressure generated from the dry powder inhalation system. Able to detect at least one signal type including force signals, flow signals, temperature signals, and audio signals. and capable of transmitting the signal to at least one device for analysis, storage, printing or display. In such an exemplary embodiment, the sensor is configured within a dry powder inhaler. or can be adapted for a dry powder inhaler, and the sensor can be a microphone. do.

[0024] In an exemplary embodiment, the inhalation system has a high resistance to airflow and Approximately 0.065 (√kPa) / liter to approximately 0.200 (√kPa) / liter per minute The high resistance inhalation system includes a dry powder inhaler having a resistance of 0.01 to 0.01 MPa. In some embodiments, the sensor may include a device that detects the amount of blood flow generated by the inhalation system during use. In another exemplary embodiment, the sensor is a sound sensor. This is a system for transmitting an audio signal in a wired or wireless communication mode to at least one The present specification also includes a sound detection device or microphone configured to transmit to one other device. The sensing and monitoring device for the dry powder inhaler described in the document further includes an audio signal, a microprocessor configured to analyze and process the at least one signal of the In another exemplary embodiment, the signal may be associated with an analog-to-digital converter that communicates with the sensor. At least one device is an analog-to-digital converter.

[0025] In one exemplary embodiment, a monitoring system for a dry powder inhaler is described, A system is a monitoring device that includes at least one sensor; an analog-to-digital converter; a data the data storage medium being read by a processing device to execute an algorithm; and an executable set of machine-readable instructions, the algorithm comprising: Steps for receiving data; steps for filtering data; steps for transforming data analyzing the data; and using the data to monitor the patient. It contains instructions for manipulating data, including one or more of the following:

[0026] In an exemplary embodiment in which at least one sensor is a microphone, the sensor , anywhere within the inhaler, for example, within the airflow conduit, within the wall of the inhaler, or as a separate piece. In another exemplary embodiment, the monitoring device is provided externally to the inhaler. The device may be a removable device that can be attached or attached to a driver inhaler. In another exemplary embodiment, the monitoring device displays a graph that is a real-time graphical representation of inhalation. Provide guidance.

[0027] In another exemplary embodiment, the audio signal may be a signal having an amplitude of the audio signal, a frequency of the audio signal, or a combination thereof. In yet another exemplary embodiment, the sensor further comprises a combination of different In another exemplary embodiment, the dry powder The dry inhaler further includes a cartridge, and the cartridge contains a dry powder for pulmonary delivery. Further, the dry powder may contain diketopiperazine microparticles and at least In yet another embodiment, the at least one drug may comprise insulin. Phosphorus, GLP-1, parathyroid hormone, calcitonin, analogs thereof, or combinations thereof Includes combinations.

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

[0029] In another exemplary embodiment, the sensing and monitoring device is adaptable to a dry powder inhaler. It may be provided as a removable device, for example a sheath or saddle structure. The removable device does not modify the structure or configuration of the dry powder inhaler, allowing for improved inhalation. Therefore, once the inhaler performance characteristics are determined and The same inhaler can be used without the outer packaging if the elephant can use it properly. In this embodiment, a sensor such as a miniature microphone may be mounted on the housing or adapter. Any area of ​​the exterior, including being recessed into the wall or protruding from the exterior wall, In this embodiment, the sensing and monitoring device may be positioned to detect the presence of a dry powder inhaler in use. This provides greater resolution of the sound characteristics coming from the instrument and cartridge system.

[0030] In one embodiment, a method is described for measuring pressure differentials during an inhalation maneuver, the method comprising: The method includes providing a subject with an inhaler, the inhaler receiving an audio signal generated by the inhaler. at least one amplitude of the audio signal, at least one frequency of the audio signal, or a combination thereof and having the subject inhale for at least one second. and; using an algorithm provided to the microprocessor within the computer system. At least one amplitude of the audio signal, at least one frequency of the audio signal, or Analyzing these combinations to generate data sets; and This includes displaying, printing, or storing the data set.

[0031] In a further embodiment, provided herein is a monitoring system for a dry powder inhaler. The monitoring system includes at least one sensor, including: an acoustic sensor, a Doppler , monitoring equipment; analog-to-digital converters; data storage media, including a set of machine-readable instructions executable by a processing device to perform an algorithm; The algorithm includes the steps of: receiving data from at least one sensor; filtering the data; filtering; transforming the data; analyzing the data; and a monitoring system including instructions for manipulating the data, including using the data to monitor the patient; The stem is explained.

[0032] Additionally, in some embodiments, the present disclosure provides a method for measuring pressure differentials during an inhalation maneuver. 1. A method comprising: providing an inhaler to a subject, the inhaler comprising administering to the subject at least one dose of a compound produced from the inhaler. At least one amplitude of the audio signal, at least one frequency of the audio signal, or a combination thereof a sensor configured to detect the combination of the two components, and to use an algorithm provided in the computer system to At least one amplitude, at least one frequency of the audio signal, or a combination thereof and displaying the data set according to time and pressure. Methods are described that include transferring, printing, or storing the image.

[0033] In other embodiments, the present disclosure provides a method for monitoring an inhalation performed by a user. A dry powder inhalation system comprising: at least one microprocessor; or containing a Doppler effect sensor and / or an infrared sensor capable of measuring gas flow. an inhaler accessory device including one or more active sensors; a dry powder inhaler, Recognition by sensory beams including laser beams, RFID, optical recognition, image sensors, etc. Possible types of identifiers, e.g. color, laser etching, printed numbers; printed words The sensory beam includes a cartridge having a color, a type of dose, etc. A dry powder inhaler capable of detecting an identifier code integrally formed on a cartridge. An interactive dry powder inhalation system is described, comprising: an image detection sensor; On-board calculators or remote calculators can be used to detect doses or other identifiers using mathematical character recognition. In some embodiments, the dry powder inhaler may be used in conjunction with a rate calculation. 0.065(√kPa) / liter per minute to 0.200(√kPa) / liter per minute flow resistance; a transducer configured to detect a signal generated from the inhaler in use; and configured to display inhalation maneuvers performed by the user in real time. In another embodiment, the transducer measures the pressure in the inhaler. The transducer senses and measures the difference between the airflow and the pressure of the dry powder inhaler. The transducer may be a flow meter configured to sense and measure the flow rate through a pipe. For example, a microphone configured to sense and measure audio signals generated from within the inhaler. It may be a microphone.

[0034] In yet another embodiment, the present disclosure provides a sensing and monitoring device compatible with dry powder inhalers. A device: structurally configured to fit into a dry powder inhaler; the removable device includes a dry powder inhaler; and a dry powder inhaler that detects sound and delivers 0 Flows from 0.065 (√kPa) / liter to 0.200 (√kPa) / liter per minute Resistive sensing and monitoring devices are described.

[0035] Additionally, in some embodiments, sensing and monitoring devices for dry powder inhalation systems The dry powder inhalation system includes a dry powder inhaler and a cartridge. , as well as sensing and monitoring equipment to measure the dry powder released from the dry powder inhalation system. a sensing device including a microphone configured to detect an audio signal generated from the formulation; Surveillance equipment is described.

[0036] In some embodiments, the dry powder inhaler comprises a housing, a movable member, and a mouth. the movable member moves the container from a powder containment position to a dispensing position. In this and other embodiments, the movable member is configured to The cartridge mounting area may be configured as part of a lid assembly at the proximal end of the device. In this embodiment, the mouthpiece forms part of the cartridge when the lid or inhaler is closed. The cover portion is integrally constructed to cover the housing over the ridge mounting area. The downward movement of the mouthpiece from the horizontal plane causes the lid or cover to move angularly to a vertical position. position to open the inhaler, providing access to the interior of the inhaler and inserting the cartridge. Conversely, the mouthpiece can be moved upward from a vertical plane to a horizontal plane. The movement in the direction of the arrow causes the inhaler to close and the inhaler and cartridge seating area to be closed. An air passage opening is automatically created between the inserted cartridge and the nozzle.

[0037] In another embodiment, the dry powder inhaler includes a body, a housing, and a mouthpiece. The inhaler has an open position, a closed position, and a cartridge that receives and holds the inhaler. Moving the inlet from an open position to a closed position allows dispensing, medication or dose delivery from a contained position. and a mechanism operatively configured to reconfigure the device to a position In versions of this embodiment, the mechanism also detects when the inhaler is opened after use. When removing the used cartridge, place the cartridge in the inhaler in the dosage position. In some embodiments, the mechanism may reconfigure the cartridge from the storage position to the containment position. After use, the device may be reconstituted into a disposable or discardable form.

[0038] In some embodiments, the body of the inhaler comprises a proximal portion including a mouthpiece, a body, and It is structurally constructed as a removable cover that covers the upper sides of multiple parts of the main body and multiple internal parts of the inhaler. and a distal portion including a housing formed therein; the housing having a distal end and a proximal end. and the proximal end has an opening that fits over and encloses a portion of the inhaler body. In some embodiments, the proximal end contacts or abuts the inhaler body to externally attach the inhaler. The inhaler is closed from the closed configuration by translating the housing over the body to the distal end. Inhaler charger that is opened by moving it in a direction to insert or remove the cartridge and / or extraction position. With the cartridge installed in the inhaler, Translation of the housing across the body in a proximal direction converts the capsule from a containment configuration to a dosage configuration. causing the cartridge to move so that the cartridge container extends beyond the opening at the proximal end. In the closed configuration, the device is pushed into the dosage form by a protrusion formed inside the housing. When inhaled, the cartridge placed in the inhaler releases the medicine in the cartridge. Additional air passages between the mouthpiece and ambient air for access to dry powder In this and other embodiments, the dosage form is reconstituted to form The air passage of the cartridge has an intake port and an exhaust port that communicate with the air passage in the mouthpiece, The mouthpiece has its own inlet and outlet ports.

[0039] In some embodiments, the body of the inhaler includes a mouthpiece formed at the proximal end of the body. and an air conduit communicating with the interior of the housing, The inhaler body may also have a mouthpiece structure that allows the inhaler body to communicate directly with the exhaust port of the ridge and the ambient air. and a cartridge mounting area continuous with the distal portion and a proximal portion; The mouthpiece and the mouthpiece form a single piece and are insertable into the housing. In some embodiments, the body and housing can be separated to access the interior compartment. In the open form of this embodiment, the dry powder The cartridge including the above may be loaded or placed in a cartridge mounting area of ​​the body, and the body and the housing is pushed or pulled to open or close the inhaler. In some embodiments, the housing can be moved from an open configuration to a closed configuration. The distal end of the body is movable over the top side thereof and together with the inhaler closes the cartridge. In this configuration, an air conduit is formed through the cartridge attached to the inhaler attachment area. is released from the inhaler upon oral inhalation by a user using a mouthpiece, This embodiment and dosage form provides a dosage form for the powder in the cartridge. The body and housing abut against each other and are held firmly in place by one or more anti-slip structures. An example of a non-slip feature is a snap-in fastener. a trigger or detent, which alerts the user that the inhaler is ready to use. In some embodiments, the inhaler is substantially rectangular. the length of the distal and proximal sides is short; the movement of the housing over the body or vice versa is , outward from the longer sides (first side and second side) of the inhaler that lie in the longitudinal plane By pulling or pushing the inhaler body having an extending guide rail or track In this embodiment, the inhaler body fits into the opening at the distal end of the housing. The device is designed with an opening at its distal end so that, upon inhalation, ambient air is drawn in. The housing also guides the device into the interior chamber. A groove or slot is provided for sliding over the rail for a snug fit. and a stop end to prevent disassembly of the inhaler, and a cartridge to form a dosage form after installation. The plunger includes a plunger for positioning the cartridge in the inhaler state and closing the inhaler. Move the cap or container against the cartridge lid to open the air passage through the cartridge. forming an inlet and an outlet, and aerosolizing the powder in the cup during inhalation. to allow aerosolization to deliver aerosolized particles to the inhaler mouthpiece and to the user. In another embodiment, the plunger also engages the cartridge assembly with the floor of the mouthpiece. In one aspect of this embodiment, the lid is moved to position the lid relative to the inlet opening. The dry powder inhaler includes a housing containing a plunger, The cartridge is moved by translating the cartridge across the inhaler body from an open configuration to a closed configuration. Position the edge so that it is aligned with the mouthpiece.

[0040] In some embodiments, the dry powder inhaler has a distal end and is in communication with ambient air. In some embodiments, the housing includes a housing configured with an opening through which the The gasket is in the form of a cover that slides over the inhaler body to substantially obscure a portion of the inhaler body. The housing is configured to translate above the distal end of the body; two forms, a first position in which the inhaler can be opened to access its internal compartment; and a second position in which the proximal end abuts the inhaler to close the inhaler. In an embodiment, the distal portion of the housing is also movable in a horizontal plane relative to the proximal end. , extending distally to provide access to the internal compartment of the inhaler and In versions of this embodiment, the housing the distal portion includes parallel structures or flanges for engaging portions of the body of the inhaler; For example, the body of the inhaler can be locked with the housing, and the two parts can be fastened together to prevent the device from being thrown. In one embodiment, the distal portion of the housing forms a locking mechanism for maintaining the drug form. The distal end of the inhaler has an opening for communicating with the interior of the inhaler and a slide-on mechanism for sliding onto the inhaler body. The distal portion of the housing also has an outer surface, an inner surface, and an opening configured therein. In some embodiments, the distal end of the inhaler includes a chamber configured to slide over the inhaler body. The upper surface of the mouthpiece has parallel wing-like features to direct the airflow into the mouthpiece during inhalation. It contains such structures.

[0041] In alternative embodiments, the mouthpiece may be attached by various mechanisms, including movable members such as hinges. and the cartridge cap is attached to the cartridge cup or container. The movable assembly includes a rack for moving the movable member relative to the movable member. The assembly receives the cartridge installed in the inhaler and moves it from a containment position to a dispensing position. The device may be configured to reconfigure from an open configuration to a closed configuration, for example, when the inhaler components are moved. It can be designed to operate manually or automatically by closing the In an embodiment, the mechanism for reconstituting the cartridge is attached to the mouthpiece and In another embodiment, the housing includes a slide tray or sled movably mounted thereon. The mechanism is attached to or adapted to the inhaler and is, for example, integrally attached within the hinge of the inhaler. In yet another embodiment, the cartridge is received and sealed by a geared mechanism. The mechanism operatively configured to reconfigure from the charging position to the dispensing position may be, for example, a housing. Some include a cam that can reconfigure the cartridge when the ring or mouthpiece is rotated. In this embodiment, angular rotation of the mouthpiece from the horizontal plane releases the inhaler and Allows installation or removal of the cartridge and angular movement of the mouthpiece from a vertical to a horizontal surface The movement closes the mouthpiece and automatically moves the cartridge from the containment position to the dispensing position. In some embodiments, the gear mechanism in operation reconfigures the inlet opening in the mouthpiece. The cartridge lid is positioned against the mouth and the cup is translated into the dosage form.

[0042] In some embodiments, an inhaler for use by a subject is provided to the subject and The patient inhalation profile activates the inhaler device and system to prompt the patient to use the inhaler mouthpiece. using an inhaler attachment device that is adapted to the inhaler by asking the patient to breathe through the device Simultaneously with the patient's breathing, the inhaler attachment is detected and monitored by the system. The display of collected data or indicators relating to such data may be provided to the patient. In this and other embodiments, the display The algorithmic application is included in the mobile phone, tablet, PDA or computer This can be seen in microwave radio wave signal transmitters and receivers, or transmitters and receivers. devices, such as Bluetooth®, Zigbee®; WiFi, Digital cellular networks such as martWave, Z-Wave, or 4G and 5G The inhaler accessory device communicates with a microprocessor, including a microwave radio wave signal. The device is detected by an application provided on a mobile phone that can communicate with the inhaler accessory. In one embodiment, microwave radio wave signals from the transceivers can be transmitted to each other. It can be transmitted from the microprocessor to communicate with the If the inhaler accessory device is a tablet, personal digital assistant (PDA), or mobile phone In embodiments where the tablet, PDA or cell phone communicates with the user, the tablet, PDA or cell phone may be programmed with an application. application, which allows you to When switched on, it communicates with the inhaler accessory device to Any information / signal generated from the stem can be detected. [Brief explanation of the drawings]

[0043] [Figure 1] 1 shows an isometric view of an embodiment of a wireless dry powder detection and sensing inhaler accessory device attached to an inhaler. [Figure 2] 1 shows an isometric view of an embodiment of a wired dry powder detection and sensing inhaler accessory device attached to an inhaler. [Figure 3] 1 shows an isometric view of the top side of an embodiment of a wireless detection and sensing inhaler accessory device. [Figure 4] 1 illustrates an isometric view of the bottom side of an embodiment of a wireless detection and sensing inhaler accessory, showing the electronics board. [Figure 5] 5 shows a top view of the electronic board of FIG. 4. [Figure 6] 2 shows an isometric view of a dry powder inhaler coupled to an embodiment of a detection and sensing inhaler accessory device as shown in FIG. 1, including an integrated signal display button. [Figure 7] 3 shows an isometric view of a dry powder inhaler coupled to an embodiment of a detection and sensing inhaler accessory device, such as that shown in FIG. 2, including a local signal display button. [Figure 8] 1 shows an isometric view of an embodiment of a wireless dry powder detection and sensing inhaler accessory device attached to an inhaler and including an integrated display screen. [Figure 9] 1 shows a block diagram of an overall embodiment of a wireless detection and monitoring system disclosed herein. [Figure 10] 1 shows a block diagram of an embodiment of a detection and monitoring system disclosed herein. [Figure 11] 1 shows a block diagram of another embodiment of the detection and monitoring system disclosed herein. [Figure 12] 10 graphically illustrates an inhalation maneuver performed by a subject by instructing them to breathe to monitor inhalation efficiency for medication administration. [Figure 13] 1 shows a block diagram of an embodiment of the wireless detection and monitoring system disclosed herein in which the inhaler accessory device includes a pressure sensor. [Figure 14] 1 shows a block diagram of an embodiment of the detection and monitoring system disclosed herein in which the inhaler accessory device includes a pressure sensor and a display. [Figure 15] 1 shows a block diagram of another embodiment of the detection and monitoring system disclosed herein, in which the inhaler accessory device includes a pressure sensor and a visual indicator. [Figure 16] 1 shows a block diagram of an embodiment of the wireless detection and monitoring system disclosed herein in which the inhaler accessory device includes a color detection sensor and a pressure sensor. [Figure 17] 1 shows a block diagram of an embodiment of the detection and monitoring system disclosed herein in which the inhaler accessory device includes a color detection sensor and a display. [Figure 18] 1 shows a block diagram of another embodiment of the detection and monitoring system disclosed herein, in which the inhaler accessory device includes a color detection sensor and a visual indicator. [Figure 19] 17 illustrates a method for training or monitoring a user's inhalation using the system of FIG. 16. [Figure 20] 1 shows an isometric view of an embodiment of a wireless dry powder detection and sensing inhaler accessory device. [Figure 21] 21 shows an isometric view of the bottom side of the embodiment of the wireless dry powder detection and sensing inhaler accessory device of FIG. 20. FIG. [Figure 22] 21 shows an isometric view of the top side of an embodiment of the wireless detection and sensing inhaler accessory of FIG. 20 attached to an embodiment of an inhaler. [Figure 23]1 is a graph showing a standard baseline curve, which is a screenshot of a cell phone display, for use in measuring and monitoring inhalation effort by a subject during training to use a dry powder inhaler. [Figure 24] 1 is a graph showing that the resulting inhalation effort of an inhalation maneuver performed by a subject instructed to breathe to monitor the inhalation efficiency of the medication was satisfactory. [Figure 25] 1 is a graph showing that the resulting inhalation effort of an inhalation maneuver performed by a naive subject breathing to monitor the efficiency of inhalation of a medication failed the parameters required for proper use of an inhaler. [Figure 26] 1 is a graph showing that the resulting inhalation effort of an inhalation maneuver performed by a naive subject breathing to monitor the efficiency of inhalation of a medication failed the parameters required for proper use of an inhaler. [Figure 27] 14 illustrates a method for training or monitoring a user's inhalation using the system of FIG. 13. [Figure 28] 14 illustrates a method for training or monitoring a user's inhalation using the system of FIG. 13. DETAILED DESCRIPTION OF THE INVENTION

[0044] This specification refers to the pressure or pressure drop and / or pressure from the subject during an inhalation maneuver using an inhaler. an interactive system for measuring or monitoring real-time changes in the characteristics of these flows; A device and / or instrument and method are disclosed. The instrument, in conjunction with an inhaler, controls the breathing of a subject. To maximize the efficiency of the and also to ensure proper dose delivery, timing of dose delivery, and proper operation of the inhalation system in use. It can be used to monitor inspiration during drug delivery to detect improper performance. In one exemplary embodiment, the sensing and monitoring device may be applied in conjunction with a high resistance inhaler. In embodiments, the detection and monitoring system may be used in conjunction with dry powder inhalers, particularly in conjunction with inhalers. Many characteristic parameters of the inhalation maneuver using the device can be measured, including the start of inhalation, Peak inhalation effort within the first 2 seconds (PIP2), total inhalation effort in the first second (AU) C1) Data generated to assess the total inhaled volume and duration of inhalation of the patient's inhalation effort. The handheld inhaler system includes two components: an inhaler and an inhaler accessory. However, those skilled in the art will appreciate that various devices may be used to measure or monitor data and characteristics during an inhalation maneuver. The inventive design of this system and method also sacrifices flexibility and reusability. Nevertheless, it will be appreciated that accessory features may be applied to devices that are integrated into the inhaler itself.

[0045] The device is adapted to be attached to or otherwise associated with an inhaler. The device includes at least one transducer or sensor. It detects at least one measurement including pressure, airflow, air volume, humidity, and temperature; and In some embodiments, the sensor can pass through the inhaler. It may include a Doppler sensing device capable of detecting air or gas flow. The sensor includes a pressure sensor that can detect a drop in pressure during an inhalation maneuver. Further, appropriate signal conditioning such as signal filtering, amplification and analog-to-digital conversion is required. The signal is then simultaneously transmitted to a computer or mobile device for receiving the signal in real time. For transfer to a terminal (PDA), e.g. a mobile phone, for displaying the signal or processed information and processing circuitry such as a microprocessor, a wired or wireless communication interface, In some embodiments, the output display may include an electronic board with circuit elements. The display device may be an interactive display, allowing the physician and / or patient to This provides a visual aid that allows the user to see the inhalation maneuver parameters. The information thus obtained is used to target repeatable inhalation maneuvers in real time. This can serve as a guide for the patient, thereby enabling proper inhaled delivery of medication during self-administration. In another exemplary embodiment, the data may be stored for later analysis. .

[0046] 1-7 illustrate embodiments of a dry powder inhaler system or training device and its components. The interactive system of training equipment described herein is disclosed in U.S. Pat. ,757, U.S. Pat. No. 8,636,001 and U.S. Provisional Patent Application No. 62 / 289,095 and for all that they disclose regarding dry powder inhalers, please refer to those disclosures. No. 6,299,499, filed on Oct. 1, 2003, which is incorporated herein by reference.

[0047] 1 and 2 show wireless and wired inhalation detection and monitoring systems 10 and 12, respectively. The system includes an air conduit 16 and an exhaust port 1 for delivering the powder to the user / patient. 7. The inhalation detection and monitoring system 10 includes an inhaler 14 including a mouthpiece 15 having a 12 also attaches to, connects to, or otherwise associates with inhaler 14. In this embodiment, the inhaler accessory device includes an inhaler accessory 18 adapted for The air conduit includes an actuation button 19 for turning on / off the power of the stems 10, 12. established between one or more intake ports to establish an air conduit path through the system; At least one air conduit pathway, when in use, contains dry powder for delivery to an individual. In some embodiments, the inhaler is passed through a container that contains No powder is added while training the patient. The inhaler 14 is a dry powder inhaler of the same type, and the inhaler accessory device 1 8 can fit onto the top surface of the inhaler 14. FIG. 1 shows an inhaler accessory 18 having an electrical wire 22 connected to the system for inhaling the inhaler.

[0048] FIG. 3 shows a top view of another embodiment of an inhaler accessory device 24 designed to fit into an inhaler. 3 and 4 show an isometric view of the bottom side of the device 24. Additionally, the attachment device 24 preferably has tabs 25, 25' for attachment to the inhaler. However, other types of fastening devices known to those skilled in the art may be used to connect the device to an inhaler. The device 24 also preferably includes a power button to activate the device for use. In this embodiment, the body includes a top surface 27, a bottom surface 28, and 4 has an electronic board 30 attached to its bottom surface 28. 4 and 5 show an embodiment of the inhaler accessory 24 having an integrated electronic board 30. Also shown is an electronic board 30. The electronic board 30 is preferably mechanically connected to the activation button 26. or otherwise connected actuator 26', sensor 29, and microprocessor. The microprocessor 32 is responsible for activating, detecting, and controlling signals from the associated inhaler. In this embodiment, the electronic The board 30 is configured as a signal processing / interface board. Any type of sensor, for example an acoustic sensor to detect the sound produced during inhalation or a pressure sensor for detecting a drop in pressure during inhalation. 24 also preferably serves as a power source to start the system when the activation button is pressed. Those skilled in the art will appreciate that the electronics contained in the inhaler accessory device 24 include: Provided as separate circuit components on separate boards connected by appropriate means required for functionality For example, it will be understood that the microprocessor 32 may determine the placement of the sensor 29. If necessary, it may be on a separate board from the sensor 29 .

[0049] In another embodiment, the inhalation detection and monitoring system may include indicators such as those shown in FIGS. FIG. 6 shows a device attached to an inhaler as shown in FIG. 1, showing signal indicators 35, 36. FIG. 7 shows an isometric view of a dry powder inhaler coupled to a device. , 36, a dry powder inhaler coupled to an inhaler accessory 18 as shown in FIG. The signal indicators 35, 36 preferably provide some sort of status indication to the user. A light emitting diode or other light indicator for indicating the status of the The data can be used to indicate whether an inhalation resulted in a successful inhalation of the drug. For example, during operation, one indicator may show a red signal light, and another indicator may show a red signal light. The indicators 35, 36 can show a green signal light. The user is given a fail or pass rating for the effective delivery of the powder in the inhaler for treatment. A failed inhalation indicator (red light) indicates the subject or patient The inhalation maneuver comprises one or more predetermined steps relating to the inhalation of a dose of powder contained in the inhaler. The pass / fail indicator (green light) indicates that the subject has not met the criteria. or the patient's inhalation maneuver is adequate to deliver the dose of powder contained in the inhaler. Alternatively, a color may be selected based on the status, or For example, if flashing can be used to indicate status, only one signal indicator The signal indicators 35, 36 are used to facilitate visual perception by the user. In other words, it can be positioned anywhere within the sheath.

[0050] In another embodiment, an LED signal is also integrated into the inhalation accessory and is used to indicate the quality of the inhalation maneuver. For example, a solid red light indicator may be used to notify the user that an inhalation has failed. and that subsequent attempts required stronger, deeper or faster inhalation. In one embodiment, a flashing red light indicator may indicate to the user that that the inhalation was unsuccessful and that subsequent inhalations should be performed for a longer period of time; In this and other embodiments, a solid green light indicator indicates that an inhalation is successful or that delivery of the contents of the dry powder inhaler to the subject during inhalation is successful. Another use of the signal indicators 35, 36 is to indicate whether the power is ON or OFF. OFF, power failure or low battery indication, or connection status between the accessory device and the inhaler This may include status.

[0051] In an alternative embodiment, the inhalation detection and monitoring system may include an annunciation system that reports the quality of the inhalation maneuver. In this embodiment, the annunciator may optionally include an indicator It is provided to be activated individually and is particularly suitable for visually impaired users.

[0052] FIG. 8 is an isometric view of an alternative embodiment of a wireless dry powder detection and sensing inhalation system 12. 1, in which the inhaler accessory device 42 is attached to the inhaler 14 and is used by the patient to perform an inhalation operation. The device is integrally formed with the body of the accessory device 42 so that the patient's inhalation effort can be visualized simultaneously. 1. In this embodiment, the display screen 44 is shown configured with a The inhaler accessory 42 includes an electronic board 30 as shown in FIGS. 4 and 5, where The signal information regarding the input is processed in the microprocessor 32, and the resulting The resulting processed information is communicated to a display screen 44 and preferably displayed on the inhaler being used. The results are shown as a graphical representation of the ingredients compared to one or more predetermined criteria. The graphs and associated data points are preferably stored locally on the electronic board 30. In this and other embodiments, the inhaler device may be stored locally or remotely. The predetermined criteria depend on the inhaler and medication in use. In some embodiments, the criteria used may be peak inspiratory pressure, emitted dose, etc., as described above. That is it.

[0053] 9, 10 and 11 show various operational examples of the inhalation detection and monitoring system shown in FIGS. 1-8. FIG. 9 shows an overall implementation of the wireless detection and monitoring system 50 disclosed herein. In FIG. 9, a block diagram of the system 50 is shown, which includes two components: an accessory 54 and a and a processing system 56. In this embodiment, the inhaler accessory 54 includes an electronic board. The electronic board includes two sensors 51, 52, a battery 53, and a microprocessor 7. 0, and a wireless communication device or transceiver 72. The sensor 52 is positioned so as to be in close proximity to the inhaler airflow conduit to form an inhalation detection and monitoring system. When the device 10, 12 is activated or switched on, an audio signal or a sound within the inhaler 14 is emitted. The system also includes a power source, e.g., a battery, that powers the system. It is powered by pressing the activation buttons 19, 26 connected to the battery 53. Alternatively, the system may be powered by a power line, such as a USB port. , preferably at any point within or adjacent to the air conduit of the inhaler accessory 18, 24. In some exemplary embodiments, the sensors 18, 24 are located on the body of the accessory device. 20 or in the air conduit near the mouthpiece 15 of the inhaler in use.

[0054] The processing system 56 may be a PDA, tablet, mobile phone, or computer 57, Playback 58, wireless communication device 59, and digital storage, web interface, printing The system may include an output 55 which may be in the form of a physical document, an email, etc. The sprayer 58, the radio 59 and the output unit 55 are not separate elements, but are simply part of a PDA / tablet. It should be understood that the device may reside in a tablet / cell phone / computer 57. In this exemplary embodiment, the user presses a power button, such as button 19 on device 10. This activates the inhaler attachment 54, which also activates the treatment system 56. The computer 57 preferably includes software designed to collect and display inhalation effort. Contains algorithms in the form of software applications or programs. Computer 5 When the software program integrated with the 7 is started, a start signal appears on the display 58. With the system activated, the user inhales 60 and the inhaler training device 5 0, which is detected by one or more of the sensors 51, 52. In this embodiment, the sensors 51, 52 are either analog or digital. The transducer may be a pressure, flow, sound, light, gas, humidity, or temperature transducer. The electrical signal generated by the sensor 51 is then sent to a signal conditioner 61, which Undesired portions of the signal, such as signal noise, are removed. The conditioned electrical signal 62 is then The signal is sent to a band limiter 63 to narrow the frequency of the signal to a desired range and then analyzed. The signal is then reduced and selected to reduce the data required, and the signal is then sent to a signal amplifier 64. , and in the signal amplifier 64, the selected signal is amplified to a predetermined voltage range; and transmitted as an amplified signal 65. The amplified signal 65 is then The digital signal is converted into a digital signal 67 by a digital converter 66. Some of the filtering, amplification, and conversion functions are incorporated into the sensor itself. It should be understood that any type of "smart" sensor may be used. Any reference to these subsequent elements in the specification addresses the use of such integrated sensors. Therefore, the digital signal 67 can be converted by the microprocessor 70. received and transmitted to a radio or transceiver 72, which , a wireless communication device 59 for receiving wireless (e.g., Bluetooth) signals 69. A wireless connection such as Bluetooth is used for transmitting the data to the computer 57. It is designed to transmit using technical standards. A software program embedded / programmed into the computer 57 59, and wireless communication from element to element. The inhaler accessory facilitates basic functions within the inhaler accessory, including passing data over line signal 69. The program also converts the electrical signals from sensors 1 and 2 into pressure values, which are displayed graphically. The display 58 may be an LED, an OLED, an LCD, a touch panel, or the like. The screen may be a touch screen, or other screen containing an interactive display. In this embodiment, a baseline curve for the user is stored in the system 50 and the inhalation signal is The baseline curve is displayed on the display 58 together with the information. to the patient when measured using the inhaler training device 10 as a reference standard for teaching It indicates the level of ability of the inhaler type to deliver a substantially accurate dose. While inhaling, the user can visually compare their inhalation performance to a baseline standard. While training the user, it is possible to omit the medication from the inhaler, so that the medication is not wasted in an unsuccessful inhalation attempt. In this way, the user can be sure that the medication is actually being inhaled. When the test is performed, the user's inhalation effort is varied to match the standard requirements. The displayed data for each inhalation taken is sent to the output 55 via a second connection 76. It can be stored, where the data can be stored or transferred as appropriate. For example, The output unit 55 may be in the form of a disk drive, a flash drive, or a printer. or for review or further training as needed. In some embodiments, the inhalation training device may provide a These signals can be transmitted to a computer / PDA / mobile / tablet and The signal from the PC / PDA / mobile / tablet can be received by the inhalation training device, This establishes two-way communication between two entities, e.g., a user However, the computer 57 stores certain information, such as patient number, dosage strength, and status comments. In this and other embodiments, the sensor 52 may input digital Sensors are sensors that can produce a digital output. Sensors include accelerometers, drones, The detected signal may be a Fluorescent Light Sensor, a Light Meter or a Laser, and the detected signal is transmitted to an internal microprocessor. The data can then be analyzed, processed, and transmitted directly to the processor. Signal information in the form of pressure versus time data can be displayed using a graphical interface, e.g. The data can be analyzed and processed using algorithms to convert it into a curve, which can then be displayed. The signal from the sensor 52 may convey information about flow, pressure differential, etc., and this information may be If both sensors 51 and 52 are used, the signal in sensor 51 will be different.

[0055] Additionally, other onboard equipment 78 transmits data via one or more cables 79, and For example, other on-board equipment can receive data from the microprocessor 70. power sensor, temperature sensor, light emitting diode (LED), alarm sound device, and other equipment These on-board instruments may include sensors such as pass / fail LED lights or audible signals. The indicator can be used to output pass / fail criteria for the inhalation maneuver. Temperature, humidity, or other environmental data can be used to determine the environment in which the inhaler was used. .

[0056] For the output of the sensor 51 following signal amplification, the amplified signal 65 is instead: The signal may be transmitted directly to the computer 57 via the radio 72, and the computer may Log-to-digital conversion and other necessary analytical steps may be performed.

[0057] FIG. 10 is an embodiment of the detection and monitoring system disclosed in FIG. 8 with an integrated display. The inhalation detection and sensing device 82 includes an integrated display 84, a micro On-board electronic system with processor 86; analog sensors 88 and digital sensors In use, the system includes an inhaler accessory device 90 that includes an actuator button 110. 9 and is powered by a battery 92. When inhaled using an inhaler fitted with an inhaler accessory device 82 containing an on-board electronic system, One or more of the sensors 88, 89 generate a signal that is transmitted to the microprocessor 86. For example, an acoustic sensor or microphone 88 generates an electrical signal 94. This electrical signal is sent to a signal conditioner 96 to remove excess noise. The electrical signal is then sent to a band limiter 98 to limit the frequency of the signal to a desired range. The signal is then narrowed to reduce the data that needs to be analyzed, after which the signal is sent to a signal amplifier 95. where the signal is amplified and sent to an analog-to-digital converter 97 and digitized. The signal is transmitted to an on-board microprocessor 86, which analyzes the information and converts it into a graph. and transmitted to the display 84 for visualization. The sensor 89 may be used in place of or in conjunction with the sensor 88 to detect the signal and a set of signals for transmission to the microprocessor 86; Similarly, the signal is analyzed, stored, and transmitted to a display 82. Other devices, including sensors, may also be included to detect other parameters of the inhaler or system. It is possible.

[0058] Figure 11 shows a visual indicator of performance showing the operating parts of the system rather than an integrated display. 1 shows a block diagram of an embodiment of a detection and monitoring system 100 disclosed herein that includes a In this embodiment, two sensors are used: an analog sensor 101 and a digital sensor 102 is provided. When the system 100 starts up, it is powered by a battery 103. , the patient / user 105 inhales, generating a signal such as a sound from the airflow moving through the inhaler conduit. The sensors 101, 102 are activated to establish and deactivate the signal from the inhaler. sensor 102 may be analog or digital, for example, from airflow detection. The output signal from the sensor 102 may be a Doppler signal that may be either When signals are digital, they require a microprocessor to analyze and process the input information. At the same time, the sensor 101 generates electrical signals, and these signals are The air signal is sensed within the inhaler and passed through a signal conditioner 106 to remove excess noise. The conditioned signal is then sent to a band limiter 108 to select the data to be analyzed. The limited signal is then sent to a signal amplifier 109, where the signal is amplified, and The received signal is then fed into an analog-to-digital converter 112. This is converted into a signal and sent to the on-board microprocessor, where it is analyzed using an algorithm. The data is analyzed and processed, thereby converting the data into, for example, a visible or optical signal and displaying the visible image. An indicator, such as a green or red light, may be displayed to indicate that the patient's inhalation effort is "passed." "was inhaled" - that is, with adequate effort to deliver the dry powder dose; or the patient's inhalation effort is insufficient to deliver the dry powder dose from the tested inhaler. In this embodiment, the other onboard equipment 115 may display the sensors used. Depending on the type of sensor, other circuits, such as other sensors, or signal conditioners, amplifiers and A / D For example, the inhaler accessory device may have two or more analog sensors. To obtain the desired signal, the electrical signal is sent to a microprocessor for analysis and processing of the information. In an alternative embodiment, a digital sensor is used. The output signals may be directly communicated with the microprocessors 86, 110.

[0059] In other embodiments, the inhaler accessory device may include a temperature sensor, a laser beam, a Doppler sensor, sensors, light meters, color sensors, text recognition, RFID, optical character recognition, optical identification, It may have one or more sensors, including turn recognition, whose output signals may be, for example: If it is not a digital signal output, it may be an analog signal output, and once those signals are Once it reaches the processor, it is converted into a digital signal for further analysis and processing. These sensors are preferably included in the inhaler accessory device and can detect which medication is being administered. the type of cartridge or other such device that is inserted into the inhaler to be administered; Identify whether a dose of medication is loaded into the inhaler.

[0060] FIG. 12 illustrates the tablet / computer / PDA / phone 57 of the processing system 56 of FIG. A screenshot is shown. The computer 57 is connected to a Bluetooth or other remote used to remotely communicate with the inhaler accessory device 54 using wireless technology, wherein: The inhaler attachment device 54 is adapted to an inhaler, and the subject is able to use the inhaler when the system is activated. You will be asked to inhale through the mouthpiece. The resulting graph shows the sensor (e.g., pressure) readings in seconds on the x-axis and the flow rate on the x-axis. The response to an inhalation maneuver is plotted as inhalation effort on the y-axis versus time. The inhalation effort by the elephant is represented by the curve A above the trapezoid B at the bottom of the graph. The outer limit (i.e., the upper area) of trapezoid B is the area where the powder in the inhaler is dispersed during ingestion. To effectively and consistently inhale a powder dose from an inhaler used to dispense the contents. This is interpreted as indicating a threshold or minimum inhalation effort that a subject needs to exert in order to achieve this. An identification sensor, such as those described herein, located within the inhaler accessory device. detects data about the inhaler, drug type, dosage, lot, expiration date, etc., and Such data is processed and the corresponding threshold data is sent to the user for display. The trapezoid also identifies the minimum performance criteria that an inhaler exhibits, or the characteristics of an inhaler that are a dry powder. The effort required to consistently deliver a dose of 90mg per patient. Figure 12 shows the effort required to inhale deeply and perform the inhalation. Inhalation maneuvers performed by subjects who could see the display screen on the tablet. As can be seen by such a curve, the subject performed within acceptable values ​​in region A.

[0061] Furthermore, FIG. 12 shows a baseline of inhalation behavior with respect to the inhaler accessory device 10 and drug identification. The curve A detected by the user is in the warning area just above area B and the The acceptable or preferred region C may be adjacent to the region B and C and the warning region. Available in colors to help identify areas when monitoring an individual's actions during inhalation Area B may be shown, for example, in red, indicating that the inhalation maneuver does not meet the baseline requirements. therefore, the delivery system is not optimal for effectively delivering the drug. The warning area may be shown in yellow to indicate that the inhalation maneuver is approaching an unacceptable effort. A preferred area C may be shown in green, indicating that the act of inhaling effectively delivers the drug. indicates that the device is within an acceptable effort to This displayed information may be used by a clinician, physician, or user to ensure proper medication administration. whether or how much effort is required to ensure proper dosing of medications The method may determine whether the .times. ...

[0062] 13, 14 and 15 illustrate various aspects of the operation of the inhalation detection and monitoring system shown in FIGS. 1-8. FIG. 13 shows an embodiment of a wireless detection and monitoring system as disclosed herein. 13 shows a block diagram of a suitable embodiment of the system 120. In FIG. 13, the system 120 comprises two components: an inhaler and an inhaler. The training device or accessory 124 includes a processing system 126. The processing system 126 , PDA, mobile phone, or computer 127, display 128, wireless communication device 129 and an output section which may be in the form of digital storage, a web interface, printed material, etc. 125. In this exemplary embodiment, the user may press a power button, e.g., By pressing the button 19 on the device 10, the processing system 126 is also activated. The inhaler training device or apparatus 120 can be activated. When the software program is started, a start signal appears on the display 128. In this embodiment, the accessory device 120 is preferably positioned so as to be in close proximity to the inhaler airflow conduit. The electronic board includes two pressure sensors 121 and 122 mounted on it, a power supply, e.g. Pressing the activation buttons 19, 26 connected to a battery 123 that powers the system When the device 10, 12 is activated or turned on, The system is activated so that the differential pressure between the inhaler 14 and the inhaler 14 and the absolute pressure of the environment can be detected. With the device inhaled, a pressure drop occurs within the inhaler training device 120 due to the user's inhalation 130. , which is measured by sensor 121. Absolute pressure sensor 122 provides information about atmospheric conditions. The pressure sensor provides data or a signal that is used to correct the differential pressure reading.

[0063] In this embodiment, sensors 121 and 122 are digital pressure sensors. Therefore, the signals generated by the sensors 121 and 122 are transmitted to the microprocessor 13 1 and the radio 132. 27 includes a software program that controls the sensor 121 and The signal generated by 122 is converted into a (corrected) pressure value, which is displayed The display may be an LED, OLED, LCD, touchscreen, or other display. It may be a screen containing a screen, a tablet, or other interactive display.

[0064] FIG. 14 shows a block diagram of an embodiment of the detection and monitoring system disclosed herein. The input detection and sensing device may include an integrated or integral display 144, a microprocessor 143, and an on-board electronic system 140 having pressure sensors 141 and 142. In use, the system is activated by a user 146 and powered by a battery 1 With the system activated, the user inhales 146. This causes a pressure drop within the inhaler training device 140, which is measured by the sensor 141. The absolute pressure sensor 142 is used to correct the differential pressure reading for atmospheric conditions. In this embodiment, sensors 141 and 142 provide digital data or signals. If an analog sensor is implemented, additional circuit elements are required. Any equipment necessary for signal conditioning, filtering, amplification and / or conversion as disclosed above. Therefore, the signals generated by the pressure sensors 141 and 142 are The microprocessor 143 is programmed to The software program implemented in the system detects the signals generated by the sensors 141 and 142. into a (corrected) pressure value, which can be displayed graphically on the display 144, This display may be an LED, OLED, LCD, touch screen, or other interactive display. The screen may include a display.

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

[0066] FIG. 16 illustrates an inhaler training device, e.g., a device, showing various additional operating components. 16 further illustrates a block diagram of the system 160. In FIG. 16, the system 160 comprises two components: , an inhaler training device or accessory 164, and a processing system 166. 66 is for tablets, PDAs, mobile phones / smartphones, smartwatches, smart Glasses or computer 167, display 168, wireless communication device 169, and digital Output 165, which may be in the form of web storage, web interface, printed material, etc. In this exemplary embodiment, the user presses a power button, e.g., By pressing the button 19, the inhaler training is started with the processing system 160 also activated. The device 160 can be started. The software program integrated into the computer 167 is started. Once started, a start signal will appear on the display 168. With the system activated, The user's inhalation 170 creates a pressure drop within the inhaler training device 160, which In this embodiment, the sensors 161 and 162 are digital Therefore, the color detection sensor 173 and the pressure sensor 161 and The signals generated by 162 are transmitted to microprocessor 171 and radio 172. The microprocessor 171 or the computer 167 may include a The software program programmed in the color detection sensor 173 and the sensor 161 and 162 are converted into cartridge information values ​​and pressure values, respectively. This can be displayed graphically on the display 168, which includes LEDs, OL The screen may be an ED, LCD, touch screen, or other interactive display. Cartridge information values ​​are used to provide limits on powder dose effectiveness. and plotted as a trapezoid B or other threshold representation on a graphical display (e.g. For example, Figures 23, 24, 25 and 26. As mentioned in the above embodiment, In addition to the detection equipment, other equipment on the equipment board may include laser, RFID, pattern or text detection. may include a light / character reader or sensor and may otherwise identify the inhaler, drug, or substance / drug. Connected to a microprocessor to identify the cartridge / packaging These sensors / readers provide the system and microprocessor with information about drugs, substances, To provide data on packaging, dosage, inhaler, etc. The data is retrieved from storage and displayed in any possible format, including graphs, to the user. It may be used as a data point on a visual, audible or other indicator. Cartridges or other packaging may be color coded or have an encrypted or coded label. RFID tags that display specific information about the drugs, such as lot, expiration date, dosage, etc. A code can be detected and sent to a microprocessor for use in calculations. A reader or sensor capable of transmitting data identifying the action and displaying the data. Perhaps certain colored packages require more effort to inhale properly. In this case, the accessory device or system is a sensor / reader. and uses the appropriate data to indicate to the user the appropriate color.

[0067] FIG. 17 shows a block diagram of an embodiment of the detection and monitoring system disclosed herein. The input detection and sensing device 180 includes an integral or integrated display 184, a microprocessor 183, color detection sensor 187 and pressure sensors 181 (differential pressure) and 182 (absolute pressure) In use, the system controls the user to 186 and powered by battery 185. In the activated state, the user's inhalation 186 creates a pressure drop within the inhaler attachment, This is measured by sensor 181. Absolute pressure sensor 182 provides information about atmospheric conditions. In this embodiment, the differential pressure reading is corrected by providing data or a signal that is used to correct the differential pressure reading. The sensors 181 and 182 are digital pressure sensors. The signals generated by 187 and the pressure sensors 181 and 182 are fed to a microprocessor. The data is transmitted to the microprocessor 183. The software program detects the color of the color sensor 187 and the sensors 181 and 182. The signal generated by the cartridge is converted into a cartridge information value and a (corrected) pressure value. This can be displayed graphically on a display 184, which may be an LED, OLED, or other display. The screen may be an LCD, touch screen, or other interactive display.

[0068] FIG. 18 shows a block diagram of an embodiment of the detection and monitoring system disclosed herein. The entrance detection and sensing device 190 includes an integrated visual indicator 194, a microprocessor 193, , a color detection sensor 197 and pressure sensors 191 (differential pressure) and 192 (absolute pressure) are provided. In use, the system controls the user 196 and powered by a battery 195. In this state, the user's inhalation 196 causes a pressure drop within the inhaler accessory, which , measured by sensor 191. Absolute pressure sensor 192 measures the differential pressure with respect to atmospheric conditions. In this embodiment, the sensor provides data or signals that are used to correct the readings. 191 and 192 are digital pressure sensors. Therefore, the color detection sensor 197 and the signals generated by the pressure sensors 191 and 192 are fed to a microprocessor 193. The software embedded / programmed in the microprocessor 193 The software program detects the color generated by the color detection sensor 197 and the sensors 191 and 192. The generated signal is converted into a cartridge information value and a (corrected) pressure value, respectively. may be used to indicate a failed inhalation or a correct / acceptable inhalation or other information. This may be used to activate a visual indicator 194 that indicates

[0069] FIG. 19 illustrates the system disclosed in FIG. 16 for detecting, monitoring, and training subjects. 2 shows a flow chart diagram of an embodiment of a method 200 for enabling a user to use the device and system. When the user presses the actuator on the inhaler attachment, the system Next, in step 202, wireless communication of the inhaler accessory device is established. The device can be connected to the user's smartphone using standard Bluetooth technology, for example. The link is established and the phone application displays a ready message and notifies the user The device is engaged with an associated inhaler or a cartridge of the substance to be inhaled into the inhaler. In step 204, the user is prompted to provide a cartridge or other disposable package. After such loading, the identification sensor, in this case the color detection sensor 173, detects the cartridge and store it in the data storage on the accessory board, or Step 2: Send the data via Bluetooth to the processing system 166 (phone) for storage. In 06, the application provides corresponding threshold data based on the color detection. Then, in step 208, the user selects several possible You will be instructed to inhale using visual, audible or screen-based messages. In step 210, during the inhalation maneuver, sensors 161 and 162 read a pressure drop. Step 212 then determines the correction steps performed by the system based on atmospheric conditions. , which occurs substantially simultaneously with or immediately after step 210. In this case, the pressure data is stored as described above, and preferably, in step 214: In step 216, the inhalation maneuver graph is matched with the threshold graph. is displayed to the user along with the inhalation result, indicating either a pass (successful inhalation) or a fail (failed inhalation). The user can then press the actuator to end the program, and The data remains stored in the output 165 for future use.

[0070] In some exemplary embodiments disclosed herein, one or more key parameters are: Total inhalation time, peak inhalation pressure, time to peak inhalation pressure, and time from the peak of total inhalation time to approximately 7 Acceptable inhalation maneuvers may be defined, including up to 5% of the mean pressure. In some embodiments, the total inhalation time is from 0.1 seconds to 5 seconds, or from 0.1 to 3 seconds. In this case, the inhalation time may be greater than 5 seconds and the peak inspiratory differential pressure may be greater than about 2 kPa, or In some embodiments, the peak inspiratory pressure may be greater than about 6 kPa. the time to peak inspiratory pressure may be less than about 1.1 seconds, and the time from peak inspiratory pressure differential to total inspiratory pressure differential may be less than about 1.1 seconds; The average pressure for up to 75% of the time is approximately 4 kPa. These values ​​are based on the inhalation monitoring system 10 , 12 and device 18, and training and monitoring inhalation with high resistance dry powder inhalers These represent the values ​​of the associated algorithms / programs used to Alternative inhaler training devices rely on the behavioral parameters necessary for optimal delivery of the inhaler medication. This can be corrected in the instrument.

[0071] In another exemplary embodiment, the dry powder inhaler is configured to Monitoring and / or detecting signals generated by or within a dry powder inhaler The dry powder inhaler may be equipped with sensing and / or monitoring equipment capable of detecting or detecting the presence of a substance. It may have sensor equipment either embedded in it or attached to it; or In an exemplary embodiment, the attachment devices 18, 24 may be attached to a mouthpiece or housing, as desired. The dry powder inhaler may be provided as an integral part of the device on the housing.

[0072] In an alternative embodiment, the inhaler accessory 18, 24 may be attached in a manner that allows it to be disengaged from the inhaler. It is a flexible / detachable sensing and monitoring device and is provided in the form of an outer sheath or cap, wherein the removable sensing and monitoring device is a dry powder adsorbent, particularly for wireless communication; The device may be provided as a removable part that can fit into the device, so that the subject using the device can In this embodiment, the exterior is made of one or more Microprocessor, radio transceiver, A / D converter, can detect signals and store signals On-board elements including sensors (such as pressure sensors or microphones) that can transmit or display It is manufactured as a separate, removable device, including the optics.

[0073] Inhalers in use with or without dry powder when using acoustic sensors The sound waves arising from the Depending on the type of sensor used, when dry powder is present, the air It can be correlated with flow rate, end of powder release during an inhalation maneuver, temperature within the inhaler passage, etc. For example, the increase in sound may be due to the flow rate through the device and / or the air stream being delivered. This may be correlated with increased powder particle collisions within the powder.

[0074] Due to their small size, sensors such as microphones can be placed anywhere within the inhaler. In embodiments where the sensor is a pressure transducer, the sensor may be positioned within the inhaler. The sensor may be disposed in an air conduit passing through one of the compartments. For example, it may be provided in an air conduit on or within the inhaler, or may be adapted to the inhaler. a cap, outer casing, or the like that can be fitted to or attached to an inhaler; As an attachment to the inhaler, which may include features such as a sleeve or saddle, a separate attachment may be provided. It may be provided as a removable part.

[0075] For removable embodiments, the sensing and monitoring attachment is simple and inexpensive to manufacture; It can also be made from plastic and works well in high resistance dry powder inhalers. In some embodiments, the sensor may be any sensor, for example, a thermocouple, a pressure transducer, or the like. Transducers, analog sensors, microphones, optical sensors, color sensors (spectrum sensors, including electromagnetic radiation sensors, including infrared sensors and visible spectrum sensors. The sensor may be a gas sensor, or any sensor capable of detecting a signal generated within the inhaler. The sensors described herein communicate or transmit signals using transceiver devices. or the signal may be adapted to: It may be transmitted using a wired connection to an analog-to-digital converter or stored.

[0076] Alternatively, an analog-to-digital converter may be provided within the inhaler, and the resulting digital Digital data is transferred directly from the device by the sensors described herein. The provided signal may be transmitted to the airflow passing through the air conduit and / or to powder particles entrained in the airflow path. The sound generated within the inhaler due to the impact of the inhaler, as well as the sound detected near the airflow path due to the inhalation operation The signal generated by the inhaler may be in several forms, including a pressure drop generated by the inhaler. are detected by the sensor and may be stored, transmitted or displayed. Other types of signals that can be emitted are text, color, ciphers or codes, which are preferred. Optical beam, laser beam, and Doppler sensors integrated into electronic boards Data can be generated from the signal and can be qualitatively and / or quantitatively In this way, the dose release time, dose, type of dose, administration time, etc. , measurements can be taken. Furthermore, these signals can be used to identify, for example, the patient, the type and dosage of the drug, may be associated with the identity of the inhaler or other device and model the data requirements for proper inhalation. It can be used in rings and facilitates training of inhaler users.

[0077] In one exemplary embodiment, the sensing and monitoring system for the inhaler is adapted to be fitted to the inhaler. accessory device structurally configured to include at least one sensor, a microprocessor, and any and a data storage medium. Drives, DVDs, CD-ROMs, servers, flash cards or drives, memory cards and a microprocessor or other processor to execute the algorithms. An algorithm contains a set of machine-readable instructions that can be executed by a device. generating a logical subsystem generation number derived from the received signal; The system generation number is stored in a data track within the logical subsystem, where the logical A step in which the subsystem generation number and the cluster generation number in the processing device are compared; and storing and / or displaying information from the algorithm as a result of the input operation. Get started.

[0078] In an alternative embodiment, the dry powder inhaler is configured to deliver a dry powder to the patient during an inhalation maneuver. Monitoring and / or detecting signals generated by or within dry powder inhalers The dry powder inhaler may be equipped with sensing and / or monitoring equipment capable of detecting or detecting the presence of a substance. It may have sensor equipment either embedded in it or attached to it; or The accessory device may be a dry powder inhaler located on the mouthpiece or housing, as desired. It may be provided as an integral part of

[0079] In an alternative embodiment, the inhaler accessory is an attachable / attachable device that can be disengaged from the inhaler. A removable sensing and monitoring device, and in the form of a sheath or cap, wherein Detachable sensing and monitoring devices are specifically adapted for wireless communication with dry powder inhalers. The subject using the device can more easily access the device by using a removable part. In this embodiment, the sheath / inhaler attachment is More than one microprocessor, radio transceiver, A / D converter, color signal detector On-board electronics for processing information, including sensors that can store, transmit or display signals It is manufactured as a separate, removable device containing the electronics.

[0080] An exemplary embodiment is shown in Figures 20-22. The attachment has a conforming proximal end 228, a distal end 230, and includes an on-board electronic system. The system includes a removable inhaler accessory 220, which is compatible with each other. The two components are the top and bottom components, and the components are A circuit board containing an electronic system that is placed on and held together by a fastening mechanism such as a screw the upper member includes arm extensions 226, 226'; The arm extension is spaced from the mouthpiece and includes a locking mechanism 223. The circuit board has a downward projection to fit snugly into the distal end of the device. a microprocessor; a differential pressure gauge; an absolute pressure gauge; and a spatial location of the accessory assembly in use. 21 shows the lower surface, bottom side member, of the body 224. , which includes a pressure equalization channel 234, which is connected to an absolute pressure sensor and a differential pressure sensor. It is configured between the absolute pressure sensor and the differential pressure sensor in use, and equalizes the pressure within the sensor. Therefore, it facilitates air communication between the absolute pressure sensor and the differential pressure sensor. The pressure sensor / differential pressure gauge is configured to be placed in close proximity to the inhaler airflow path, An absolute pressure sensor / gauge may be located anywhere on the device, in communication with the inhaler's airway. In a preferred embodiment, the absolute pressure sensor is configured within the circuit board and is connected to a pressure equalization circuit. The system communicates with the differential pressure sensor through channel 234. When communication between the sensor and the differential pressure sensor is interrupted, the intake detection and monitoring system will not function. The main body 224 is also configured with an opening 236 on its underside. This acts as a reset button to re-power the system if the activation button 225 fails. It makes it accessible.

[0081] The body 224 also includes a power supply for powering or switching off the system 220. and an activation (on / off) button 225 connected to a power source such as a lithium battery; USB port for recharging the system 220 or downloading stored information 232; LE for displaying a light signal such as a red (fail) or green (pass) signal Includes a D light quality signal indicator 227; displays the status of the power / charging connector a system status indicator 229 configured adjacent to the activation button 225 for In a specific embodiment, depending on the complexity of the system, at least two emitters A sensor with a single receiver and at least two receivers may be used.

[0082] In this and other embodiments, during use, the inhaler accessory 220 including the accelerometer When the accessory device 220 is mounted on the inhaler, the spatial orientation of the inhaler can be detected. For example, FIG. 22 shows an inhalation detector including an inhaler 242 adapted with a wireless inhaler accessory 220. An output monitoring system 240 is shown. In this embodiment, when the system is activated, Using a mobile application, the movement can inform the user of the correct positioning of the inhaler. The device may be displayed on the screen of a mobile phone, tablet, etc. If used in the wrong position prior to the inhalation maneuver to deliver the The display will show the correct / proper orientation (green / white) or the incorrect / failed orientation (red). Or the device is not connected to a PDA, computer, mobile phone, etc. In some cases, depending on the user's positioning of the device, a haptic feedback signal or a visual signal is generated. The orientation information is generated from the device 220 and indicates whether the device is in a proper or improper orientation during use. In yet another embodiment, the inhalation detection The monitoring enclosure contains one or more microprocessors, radio transceivers, A / D converters, and signal detectors. Includes on-board electronics including sensors that can emit and store, transmit, or display signals. In this embodiment, the software application The application is running on a wireless device rather than a desktop or laptop computer. The app can be used on devices such as smartphones and / or tablets. A graphical interface showing a three-dimensional model of the inhaler may be provided. The controller may provide feedback regarding the spatial orientation of the inhaler. For example, the controller may If the inhaler is held at the wrong angle while inhaling, the user will see a 3D inhalation image on the screen. By changing the color of the fitting model, attention can be drawn to improper use, e.g. , the 3D model may appear in red. Improper use of the inhaler may result in a decrease in the powder content of the medication. Instead, the voice / table app on the phone can help you avoid misdirection of the inhaler. Improper positioning of the inhaler can be prevented by providing a visual or audible warning to the user. This indicates the purpose.

[0083] In another embodiment, the inhalation accessory detects a plurality of distinct wavelengths and includes a plurality of distinct wavelength measurement channels. The color sensor includes a color channel. The color sensor can detect, for example, the color of the capsule or the color of the liquid in use. The cartridge's identity by powder dose, The amount of powder can be identified and a high quality release of the powder in the inhaler can be provided. The sensor can be activated by LED light, audible / announcement to the user, or haptic feedback such as vibration. , the user may be alerted to these parameters. A color sensor is used, where the sensor determines the specific color of the cartridge or capsule. This type can detect discrete or continuous wavelengths that can be manipulated algorithmically for It uses a spectral sensor to determine which color cartridge is in use and The dosage information of the cartridge can be used to determine whether the contents of the ridge are equivalent to the dosage strength. , the user may be notified or sent data to confirm the dose, or The data can be stored in the instrument for later comparison. To further improve the accuracy of the data, it can be analyzed by artificial intelligence algorithms.

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

[0085] In one embodiment, the inhaler accessory device detects the pressure of the inhaler by a pressure sensor when the user begins an inhalation effort. This embodiment includes an automatic collection system that detects the start of an inhalation maneuver, as measured by the In the system, the pressure sensor is configured to detect a pressure difference at a predetermined value, and In some embodiments, the entire system is automatically activated to operate. The collection may also be automatically switched off after a period of time that may be preset in the device. In this embodiment, the data acquisition target is the entire inhalation operation and detection of the cartridge during use. In one embodiment, the inhalation effort exerted by the subject is automatically increased once a minimum threshold is reached. It is measured dynamically.

[0086] In another embodiment, the inhaler accessory device controls the inhalation operation and cartridge dosing or utilization parameters. Data on inhalers and cartridges in use, including flow characteristics of the inhaler and powder It includes a system for storing and transmitting information so that the information can be used to identify target usage patterns and and / or can be analyzed to optimize treatment compliance with the medication regimen. In embodiments, the inhaler accessory device monitors the subject's usage and consistency of delivery of the therapeutic dose. In one embodiment, the data acquired by the device is stored on the device and is accessible via a digital application. The results can be transmitted to a clinical application where they can be analyzed for optimal therapeutic benefit for the patient.

[0087] In yet another embodiment, sensors such as Doppler ultrasonic sensors or "time of flight" sensors A sensor can be used to measure the amount of powder released. A Doppler sensor can The ultrasonic diffraction signal from the powder flow from the inhaler during use can be detected. The parameter is the amount of powder released from the inhaler during inhalation and / or the quality of the inhalation maneuver (as determined by the user). The amount of powder to be inhaled may provide feedback to the user. LED illumination, haptic feedback (e.g. vibration), or audible / announcement feedback. For example, an LED on the exterior or tablet may provide a continuous red the LED to remind the user to inhale more firmly, or The red LED can be flashed to remind the user to inhale longer or switched off. A seamless green LED may be used to remind the user to inhale correctly. The use of haptic feedback on tablets, where vibrations stimulate the user The device may remind the user to inhale more firmly or may vibrate several times to Remind the user to inhale longer or indicate correct inhalation by the absence of vibration. In another example, the device may be configured to specifically assist the visually impaired in administering the powder. can inform the patient of the quality of inhalation.

[0088] Train the subject to properly use the inhaler to deliver an effective amount of powdered medication by inhalation. 23-24 show the state before the sole use of the inhalation detection and monitoring device shown in Figs. 20-22. Figure 1 shows an example of an inhalation maneuver performed by an inexperienced subject. For training purposes, the powder dose was To prevent this, empty cartridges or placebo powder can be used. Screenshot of the Bluetooth transmitter and receiver for inhalation detection and monitoring device 22 0, where the inhalation effort by the subject is the time indicator in seconds. A standard baseline curve (blank area) is displayed to measure (Figure 23).

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

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

[0091] 27 and 28 are flowcharts illustrating the operational steps of an embodiment of an inhalation detection and monitoring device in use. Figure 27 shows a flow chart of an inhaler for use with a dry powder inhaler. For example, the AFREZZA® inhaler (MannKind Corp.) It is fitted with a removable detection and monitoring device. As shown in Figure 27, at the start of training, inhalation detection The monitoring equipment is assembled to the inhaler as shown in Figure 22. All equipment is assembled in the same step. Power is applied at 250. The patient's food intake or the patient's blood glucose level is measured at step 253. Depending on the amount of the 4 units, 8 units, or 12 or 16 units are selected, and in step 254, the inhaler is opened and the card is inserted. The cartridge is installed in the inhaler by inserting it into the cartridge mounting area. Once the appropriate dose cartridge has been inserted into the inhaler, the inhaler is A sensor, which may include an optical or color sensor, is triggered to close the inhaler. The identification information of the cartridge in the cartridge mounting area is detected, and the data is stored. Once the cartridge is detected in the inhaler, Once the device is inhaled, an orientation assessment 258 and the position of the inhaler are analyzed prior to inhalation. The signal received by the tablet is absorbed and displayed in an acceptable color selected for the appropriate spatial location. A three-dimensional model of the tool is displayed on the wireless device screen, and the display is displayed in 260. In 262, an app that displays a graphical interface is used. The color selected for the 3D representation of the inhaler when it is in a particular correct / suitable orientation for insertion 269. In 261, improper rotation and pitch of the inhaler If the inhaler is in an incorrect / inappropriate position for inhalation due to As a failure indicator different from that selected for a correctly positioned inhaler, e.g. If the inhaler position is corrected in step 266, the inhaler The 3D model will change to the selected color. When you start inhaling, the pressure sensor will be triggered. , and an assessment of the quality of the inhalation is performed by the processing system 270. In 272, The processing system calculates and displays a signal corresponding to the quality of the inhalation maneuver. The device (exterior) displays a visible signal from a high-quality LED signal display 274, which indicates Incorrect / incorrect inhalation efforts made in 273 were indicated by a solid red LED ( This is because in step 276, the intake was weak, and the subsequent intake was stronger and (informs the user that the inhalation needs to be stronger) or the inhalation taken is of too short duration Incorrect / incorrect inhalation efforts caused by 8, the user is advised that subsequent inhalation efforts need to be longer to achieve proper inhalation. and step 279, A continuous green LED light display that meets all standards required for targeted delivery of the drug is.

[0092] In a further embodiment for use in conjunction with diabetes therapy, the blood glucose meter comprises a removable The device may be incorporated into an inhalation detection and monitoring device / sheath, wherein the shroud is a smart blood glucose monitor. Measure blood glucose levels using a blood glucose monitor and blood samples to determine the subject's blood glucose level and treatment plan. The smart blood glucose test strips can minimize the number of devices that need to be used by the subject. It communicates with a radio transmitter and receiver in the inhalation detection and monitoring device and is calculated from information obtained from the blood sample. Prior to determining the appropriate dose required by a patient to lower their blood glucose levels, Upon standing, blood glucose levels may be determined.

[0093] In an alternative embodiment of use, shown in FIG. 28, a subject is trained to use an inhaler. Steps 280 to 298 are similar or identical to steps 250 to 274. , the devices are configured and programmed with different communication codes and visual indication signals. In this embodiment, the inhalation detection and monitoring device may be displayed only on the device or on a mobile phone or This includes an alternative device-specific visible signal that can be linked to a device or tablet. After steps 280 to 296 are performed, in step 297, the inhalation parameters are The quality of the inhalation was assessed in 298 cases, followed by a treatment program. In step 299, the smartphone / tablet The Rett graphical interface displays a graph of acceptable inhalations. A red, unmarked graphical indicator indicates an incorrect / incorrect inhalation maneuver / effort and and the user should ensure that subsequent inhalations are accompanied by a clear, sharp inhalation effort indicative of adequate dry powder dosing. Inhale more firmly until a green graphical indicator display without eyes is achieved In step 300, the user is instructed to If the indicator displays red and green graphs, the inhalation effort is incorrect / incorrect. , a continuous green graph display must be achieved, and the user must inhale for a longer period of time. Once the user has finished the process, after a few attempts, they are prompted to Once the user interface is achieved, the user is properly trained and able to use the inhaler. The removable detection and sensing device is powered off and the user is ready to begin the medication regimen. can be trained and sent home.

[0094] In certain embodiments, the inhaler accessory device may comprise, inter alia, a unit dose cartridge and, e.g., a Ketopiperazines, in particular fumaryl diketopiperazine, as well as active ingredients such as peptides and and proteins, such as endocrine hormones including parathyroid hormone, insulin, and oxin Tomodulin and glucagon-like peptide 1; symlin or praml Antihistamine acetate, nicotine, neurotransmitters such as cannabinoids, 5-hydroxytryptamine amine, dopaminergic, prostacyclin, opioid and a drug delivery formulation comprising an agonist and an antagonist. In some embodiments, the active ingredient in the formulation includes, but is not limited to, salmeterol ol, epinephrine, tacrolimus, vancomycin, linezolid, filgastrin, Fentanyl, cannabinoids such as cannabidiol and tetrahydrocannabinol (THC), or their derivatives; palonosetron, amphotericin B, phosphodiesterase PDE5 inhibitors, such as sildenafil, avanafil, bell Verdenafil and tadalafil; prostaglandins, prosta Cyclins, e.g., treprostinil; neurotransmitter agonists; neurotransmitter antagonists, e.g., anti-nociceptive agents, opioid analgesics, For example, delta opioid agonists and antagonists, kappa opioid receptor agonists and antagonists, mu opioid Id receptor agonists and antagonists, nicotine, norepinephrine dopamine reuptake inhibitors (NDRIs) and nicotinic receptor antagonists, nicotinic acetylcholine receptor agonists, Renicline, cytisine, bupropion, their derivatives, and pharmaceutically acceptable salts thereof or a combination thereof.

[0095] An inhaler accessory device is provided, the inhaler accessory device being: attached to or connected to an inhaler a microprocessor and at least two pressure sensors; a first pressure sensor for detecting information about an environmental condition surrounding the inhaler; and a second pressure sensor for detecting a signal generated from the inhaler; a pressure equalization channel between the force sensor and the second pressure sensor, The pressure sensor and the second pressure sensor each generate at least one signal. The signal is processed in the microprocessor to generate a customized microprocessor. and the microprocessor output is synchronized with or Immediately thereafter, a pressure difference versus time curve is generated on the display. The force sensor and the second pressure sensor are digital sensors, and their outputs are digital. It is characterized by its barrel format.

[0096] The inhaler accessory device further comprises: the second pressure sensor being an analog sensor; The output is in analog form, and the device further conditions, filters, and adjusts the sensor signal. and further comprising additional circuitry for amplifying and / or converting to digital form. obtain.

[0097] the second pressure sensor detects a measured pressure drop in the inhaler flow path; and further wherein the second pressure sensor detects atmospheric pressure. .

[0098] Additionally, the visible light or enhanced light signal emitted from the inhaler during use under ambient conditions In this embodiment, the inhaler accessory includes an optical sensor for detecting The device further includes a light emitting diode.

[0099] Additionally, the properties of multiple sections of an inhaler, an inhaler cartridge, or other drug packaging may be Laser beams, Doppler sensors, and infrared sensors configured to detect files In one embodiment, the inhaler accessory includes a sensing beam or other sensing beam. Inhalers for use with include dry powder inhalers. The inhaler accessory device as described above is a dry powder formulation containing a cartridge. The dry powder inhaler includes a diketopiperazine and at least one Contains one active ingredient.

[0100] The differential pressure sensor detects the pressure drop measured across the inhaler and the absolute pressure sensor The sensor, if necessary, adjusts for atmospheric conditions before identifying the pressure drop. , an inhaler accessory device as described above in combination with a differential pressure sensor.

[0101] Additionally: sensing the color of an inhaler cartridge or other drug packaging inserted into an inhaler Color detection sensors, RFI in cartridges or other drug packaging installed in inhalers RFID reader for reading the D tag and the inhaler or inhaler cartridge or Image detection capable of identifying letters, codes or text information provided on other drug packages An inhaler accessory device as described above, including one or more of the sensors.

[0102] Furthermore, data received from at least two sensors is sent to a remote processing system. It includes a radio transceiver and electronic board that receives signals, as well as a microprocessor, sensors, and the radio transceiver is connected to and / or disposed on the electronic board, In one embodiment, the inhaler attachment device further comprises a visual indicator. or ideal or predetermined inhalation parameters and the user achieved / performed In some embodiments, the device further comprises a display for displaying the difference between the inhalation maneuver and the inhalation maneuver. The inhaler attachment device has a visible pass / fail indicator to the user, i.e., green In some embodiments, the inhalation line is characterized by a color / red indicator. If this is successful, other modes of communication to the user may be possible, e.g., remote storage. This can be used by graphical or other display formats within the mart device.

[0103] Dry Powder Inhaler Monitoring and Detection Systems are also offered. These systems: - an inhaler; a microprocessor, a radio transceiver, and a pressure sensor for an area or part of said inhaler a first sensor for detecting the differential information; and detecting a signal generated from the inhaler during use. a second pressure sensor communicating with the first sensor by a pressure equalization channel; The first and second pressure sensors each generate at least one signal, the signal being: A customized microprocessor is processed by the microprocessor. - output, and the microprocessor output is indicative of the inhalation maneuver performed by the user. Graphical display of pressure versus time curve characteristics of inhaler with pre-defined profiles for inhaler type. The dry powder inhaler monitoring and detection system also Further, a display, a wireless transceiver, and a threshold value corresponding to the detected first sensor information. and a display including showing user inhalation data corresponding to the second sensor signal. a microprocessor configured to report a graphical indication of pass or fail. The system may include a remote processing system, including a

[0104] In one embodiment, the dry powder inhaler monitoring and detection system further comprises a A main body that carries or is connected to a microprocessor, a radio transceiver, and a sensor The inhaler accessory includes a removable inhaler accessory including a body in which the sensor is disposed.

[0105] A method for monitoring and detecting accurate data useful in training inhaler users is also provided. The method includes: displaying instructions for loading the inhaler with the medication; displaying medication or inhaler information; Reading the data and relating the data to a corresponding threshold; displaying a display; identifying pressure differential data during inhalation by a user; The user passes the inhalation maneuver in terms of meeting, exceeding, or failing to achieve the threshold. In one embodiment, the method further comprises determining whether the test passed or failed. A state machine that transmits and displays an indication of whether the user passed or failed the inhalation maneuver. The steps of transmitting and displaying the image include a smartphone, tablet, or computer. displaying the information on a processing system such as a computer or other wireless communication enabled device; and transmitting and displaying the medicine data and the pressure difference data by wireless transmission to a processing system. and transmitting, in the system, a pressure versus time curve together with a threshold value corresponding to the medication data. In some embodiments, the corresponding threshold is a threshold that removes background noise. This is a predetermined value set for the latter inhaler type. [Example]

[0106] Example 1 Use of integrated training equipment A 60-year-old patient with type 1 diabetes develops elevated hemoglobin A1c levels that are deemed uncontrolled. Inhaled insulin delivered by a dry powder inhalation system is used for dietary therapy. Patients are instructed to use an insulin pump for basal insulin. The patient is provided with a removable inhalation accessory device as shown in Figure 1. Patients are provided with the device and trained in wireless inhalation using such a device. When using the device (which may or may not contain medicine), ask the patient to take deep, fast breaths. It can be seen.

[0107] A pressure sensor in the inhaler is used to detect pressure drops during inhalation, and the data is collected and stored in the relevant The image is transmitted to a Bluetooth-enabled tablet with the application. The sensor detects the color of the cartridge (filled or empty) and uses the data to , identifying a threshold region for minimum inhalation pressure. Data is read from a radio wave signal from the device. collected on a tablet with a programmed application that can be taken, The patient can view the data in real time on the display screen. The first inhalation attempt was too slow and the screen showed the red "unacceptable zone" in Figure 12. The patient is instructed to take another fast breath and This is slightly faster and deeper than the previous attempt. Upon completing the inhalation, the graph The inhalation maneuver is acceptable and generally falls within the acceptable region (region C) of the graph in FIG. Once trained, patients are able to use similar inhalers with the medication. It bears fruit.

[0108] The patient was provided with a dry powder inhaler similar to the type shown in Figure 1, and Inhaled insulin cartridges are prescribed in various doses for After six months of prescribed insulin, the patient's diabetes is considered under control.

[0109] Example 2 Use of detachable / attachable training equipment: A 59-year-old patient with type 2 diabetes receives inhaled insulin via a dry powder inhalation system. The patient requested an inhalation system due to its convenience. Patients are trained in wireless inhalation using a device similar to that shown in Figures 3-5. When using the device of Figure 1 with an attachable inhaler device and training device The subject is then asked to take deep, fast breaths. An example of an inhalation maneuver performed by the subject is shown in Figure 1. 23, 24, 25 and 26, and described above.

[0110] Pressure and color identification data is collected by a mobile phone and the patient can view the data on a display screen. The patient's first attempt is the result of the software. As shown in the graphed or otherwise visually displayed threshold vs. inhalation data, Once trained and familiarized, patients become confident in using the device.

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

[0112] The above disclosure is an illustrative embodiment. Those skilled in the art will appreciate that the techniques disclosed herein are It should be understood that the present disclosure illustrates representative techniques that work well in the practice of the present disclosure. However, those skilled in the art will recognize in light of this disclosure that many variations may be made to the specific embodiments disclosed. may be made in other embodiments, but without departing from the spirit and scope of the present disclosure. It should be understood that the results obtained are:

[0113] Unless otherwise indicated, the amounts, characteristics, examples, and other information regarding ingredients used in this specification and claims are not intended to be limiting. All numbers expressing, for example, molecular weight, reaction conditions, etc., are in all cases modified by the term "about." Accordingly, unless indicated to the contrary, the present specification and accompanying The numerical parameters set forth in the appended claims are intended to be illustrative and not restrictive of the desired characteristics sought to be obtained. These are approximations that may vary depending on the nature of the invention. While not intended to limit the application of the present invention, each numerical parameter should at least be in light of the number of significant digits used and by applying normal rounding techniques. The numerical ranges and parameters setting forth the broad scope of the disclosed embodiments are approximations. Nevertheless, the figures illustrated in the specific examples are reported as accurately as possible. However, any values ​​necessarily vary due to the standard deviation found in their respective testing measurements. It inherently contains certain errors that occur in the

[0114] As used in the context of describing disclosed embodiments (particularly in the context of the claims below), The words "a," "an," "the," and similar referents are used herein unless otherwise indicated. or "a," "the ... Reference herein to a range of values ​​simply refers to each separate value falling within the range. It serves as a shorthand way of referring to each individual item. , each separate value is incorporated herein as if it were individually listed herein. All methods described herein are incorporated herein unless otherwise indicated. or otherwise performed in any suitable order unless clearly contradicted by context. Any and all examples or exemplary language provided herein (e.g., "etc. The use of "such as" is merely to further clarify the disclosed embodiments. and does not otherwise limit the scope of the claimed embodiments. No written language indicates any non-claimed element essential to the practice of the embodiments disclosed and contemplated. should not be considered to be

[0115] Certain embodiments disclosed herein consist of or consist essentially of language The scope of the claims may be further defined using the following terms: When a transitional term such as "consisting of" is used, whether as filed or added by amendment, excludes any element, step, or ingredient not specified in the claim. The transitional term "consisting essentially of" refers to the composition comprising specified materials or steps and basic and novel characteristics. The patent limits the scope of the claims to those that do not materially affect the The embodiments are inherently or expressly described and enabled herein.

[0116] Groupings of alternative elements or embodiments disclosed herein are not to be construed as limitations. Each group member may not act individually or in any way in relation to other members of the group or this Agreement. It may be recited and claimed in any combination with other elements found in the document. For reasons of relevance and / or patentability, one or more members of a group may be included in a group. It is understood that any such inclusion or deletion may be made in any way. When a group is referred to as a group, the specification is deemed to include the group as so modified. Therefore, it is necessary to satisfy all Markush Group specifications used in the accompanying claims. Add.

[0117] Some embodiments are not intended to be limiting unless the authors of this disclosure have been specifically directed to implementing the disclosed and contemplated embodiments. This disclosure, including the best mode known to those skilled in the art, is herein described. and variations on these described embodiments will be apparent to those skilled in the art. It is expected that those skilled in the art will make appropriate use of such variations, and the authors disclose and consider It is not intended that the embodiments may be practiced otherwise than as specifically described herein. Accordingly, the embodiments disclosed and contemplated herein may be used in conjunction with any of the following methods as permitted by applicable law: It includes all modifications and equivalents of the subject matter recited in the appended claims. Any combination of the above-described elements in all variations thereof is encompassed by the present invention unless otherwise indicated herein. to the extent or otherwise clearly contradicted by context, are included in this disclosure.

[0118] Additionally, numerous references to patents and publications are made throughout this specification. and publications are each individually incorporated herein by reference in their entirety.

[0119] In conclusion, the embodiments disclosed and contemplated herein are intended to be illustrative and not restrictive of the principles of the invention. It should be understood that other modifications that may be used are within the scope of this disclosure. Thus, by way of example, and not of limitation, alternative embodiments may be implemented in accordance with the teachings herein. Accordingly, the disclosed embodiments may be used in accordance with the methods and apparatus shown and described. However, it is not limited to the above.

Claims

1. a body configured to be attached to or connected to an inhaler; a microprocessor; At least two pressure sensors for detecting information about environmental conditions surrounding the inhaler. a first pressure sensor for detecting a signal generated from said inhaler in use; a second pressure sensor for detecting the pressure difference; a pressure equalization channel between the first pressure sensor and the second pressure sensor; An inhaler accessory device comprising: The first pressure sensor and the second pressure sensor each include at least one a signal that is processed by the microprocessor to generate a customized signal; The microprocessor output is then adjusted to the user's an inhaler accessory that generates a pressure differential versus time curve on a display simultaneously with or immediately after inhalation; Place.

2. the first pressure sensor and the second pressure sensor are digital sensors; and 10. The inhaler accessory of claim 1, wherein the outputs are in digital form.

3. The second pressure sensor is an analog sensor, and its output is in analog form. and the device further comprises conditioning, filtering, amplifying and / or 10. The inhaler accessory of claim 1, including additional circuitry for conversion to digital format. Place.

4. The second pressure sensor detects a measured pressure drop in the inhaler flow path. The inhaler accessory device according to claim 1 .

5. 2. The inhaler accessory of claim 1, wherein the second pressure sensor detects atmospheric pressure.

6. Additionally, the visible light or enhanced light signal emitted from the inhaler during use under ambient conditions The inhaler accessory of claim 5, further comprising an optical sensor for detecting

7. 7. The inhaler accessory of claim 6, further comprising a light emitting diode.

8. Additionally, the characteristics of the inhaler portions, inhaler cartridge, or other medication package. Laser beams, Doppler sensors, infrared sensors configured to detect profiles 10. The inhaler accessory of claim 1, comprising a sensor or other sensing beam.

9. 10. The method of claim 1, further comprising: An accessory device for an inhaler.

10. 10. The dry powder inhaler of claim 9, wherein the dry powder inhaler comprises a cartridge and a dry powder formulation. The inhaler accessory device according to claim 1.

11. The dry powder formulation comprises a diketopiperazine and at least one active ingredient. The inhaler accessory device according to claim 10.

12. The differential pressure sensor is an absolute pressure sensor used in the inhaler and in conjunction with the differential pressure sensor. and, if necessary, detecting a pressure drop measured within the 10. The inhaler accessory of claim 1, which adjusts for atmospheric conditions.

13. Furthermore, the color of the inhaler cartridge or other drug package inserted in the inhaler is sensed. a color detection sensor for detecting the presence of a color in the inhaler, a cartridge or other drug package inserted in the inhaler, an RFID reader for reading an RFID tag located in the inhaler or Letters, codes or text information provided on the inhaler cartridge or other medication packaging 10. The inhaler accessory of claim 1, further comprising one or more image detection sensors capable of identifying information. Device.

14. Further, a wireless transceiver is included, and the wireless transceiver is used to transmit the at least two sensors.

10. The inhaler of claim 1, wherein data received from the inhaler is transmitted to a remote processing system. Accessory equipment.

15. Further, an electronic board is included, and the microprocessor, the sensor, and the radio transceiver are 15. The electronic board according to claim 14, wherein the electronic board is connected to and / or arranged on the electronic board. The inhaler accessory device according to claim 1.

16. Furthermore, ideal or predetermined inhalation parameters and the user's achieved / performed 10. The method of claim 1, further comprising: providing a visual indicator or display for indicating the difference between the inhalation maneuver and the inhalation maneuver. An accessory device for an inhaler.

17. The visual indicator may be a pass / fail or green / red indicator to the user. The inhaler accessory device according to claim 16, which is a nozzle.

18. Dry powder inhalers; microprocessor, Radio transmitters and receivers, and a first sensor for detecting information regarding a pressure differential across an area or portion of the inhaler; and Beauty a second pressure sensor for detecting a signal generated by the inhaler during use; 1. A dry powder inhaler monitoring and detection system comprising: the second pressure sensor communicates with the first sensor through a pressure equalization channel; and Beauty The first and second pressure sensors each generate at least one signal; The signal is processed by the microprocessor and sent to a customized microprocessor. The microprocessor output is a signal representing the inhalation maneuver performed by the user. A graphical representation of the pressure versus time curve characteristic of the inhaler operation is provided according to a predetermined profile for the inhaler type. A dry powder inhaler monitoring and detection system that generates and compares file values ​​as a graph.

19. Further, a display, a wireless transceiver, and a display device corresponding to the detected first sensor information are provided. and displaying user inhalation data corresponding to said second sensor signal. configured to report the pass or fail indication graphically on the display. and a microprocessor running the remote processing system according to claim 1.

9. The dry powder inhaler monitoring and detection system of claim 8.

20. Furthermore, a main body attached to or connected to the inhaler, a removable body including a processor, a wireless transceiver, and a sensor disposed therein; 20. The dry powder inhaler monitoring and detection system of claim 18, including a flexible inhaler accessory. Tem.

21. 1. A method for monitoring and detecting accurate data useful in training inhaler users, comprising: displaying instructions for loading medication into the inhaler; Reading drug data related to drug information or inhaler information and relating the data to a corresponding threshold value To attach; Displaying instructions to begin the inhalation maneuver; identifying pressure differential data during inhalation by a user; Meeting or exceeding the corresponding threshold, or failing to achieve the corresponding threshold determining whether the inhalation maneuver of the inhaler user passed or failed with respect to To do A method comprising:

22. Additionally, an indication of whether the user passed or failed the inhalation maneuver is transmitted and displayed.

22. The method of claim 21, comprising the step of:

23. The steps of transmitting and displaying may be performed using a smartphone, tablet, computer, or 23. The method of claim 22, including displaying to a processing system such as another wireless communication enabled device. method.

24. The transmitting and displaying step includes wirelessly transmitting the medicine data and the pressure difference data. transmitting the pressure versus time curve to the processing system; 24. The method of claim 23, including displaying the medication data along with a corresponding threshold.

25. The wireless transmission may be implemented using Bluetooth (registered trademark), Zigbee (registered trademark), Wi-Fi Wi-Fi, SmartWave, Z-Wave, or digital cellular networks; 25. The method of claim 24.

26. The at least one active ingredient is insulin or an insulin analogue, sildenafil , avanafil, verdenafil, treprostinil, tadalafil, epinephrine, 12. The inhaler accessory of claim 11, comprising tetrahydrocannabinol and cannabidiol. Place.

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