Apparatus, system and method for detecting and monitoring inhalations

Abstract

Described herein are an interactive apparatus and methods for sensing and measuring real-time characteristic patterns of a subject's use of a dry powder inhalation system. The 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 as the inhalation is performed and thus the subject's inhalation can be evaluated as well as the performance of the inhalation system. 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.

We claim: 
     
         1 . An inhaler accessory apparatus comprising:
 a body configured for mounting onto or connection with an inhaler;   a microprocessor,   at least two pressure sensors, a first pressure sensor for detecting information on environmental conditions around said inhaler; and a second pressure sensor for detecting signals generated from said inhaler when in use, and   a pressure equalization channel between said first pressure sensor and said second pressure sensor,   wherein said first pressure sensor and said second pressure sensor generate at least one signal each which is processed in said microprocessor resulting in customized microprocessor output and wherein said microprocessor output generates a pressure differential versus time curve on a display concurrently with or immediately after a user's inhalation.   
     
     
         2 . The inhaler accessory apparatus of  claim 1 , wherein said first pressure sensor and said second pressure sensor are digital sensors and their output is in digital form. 
     
     
         3 . The inhaler accessory apparatus of  claim 1 , wherein said second pressure sensor is an analog sensor and its output is in analog form and wherein the apparatus further comprises additional circuitry to condition, filter, amplify and/or convert a sensor signal to digital form. 
     
     
         4 . The inhaler accessory apparatus of  claim 1 , wherein said second pressure sensor detects a pressure drop measured in an inhaler flow pathway. 
     
     
         5 . The inhaler accessory apparatus of  claim 1 , wherein said second pressure sensor detects atmospheric pressure. 
     
     
         6 . The inhaler accessory apparatus of  claim 5 , further comprising a photo sensor which detects visible light or augmented light signals emitted from said inhaler in use in ambient conditions. 
     
     
         7 . The inhaler accessory apparatus of  claim 6 , further comprising a light emitting diode. 
     
     
         8 . The inhaler accessory apparatus of  claim 1 , further comprising a laser beam, a Doppler sensor, infrared sensor or other sensing beam configured to detect characteristic profile of parts of the inhaler, inhaler cartridge, or other medicament package. 
     
     
         9 . The inhaler accessory apparatus of  claim 1 , further comprising an accelerometer and wherein the inhaler comprises a dry powder inhaler. 
     
     
         10 . The inhaler accessory apparatus of  claim 9 , wherein said dry powder inhaler comprises a cartridge and a dry powder formulation. 
     
     
         11 . The inhaler accessory apparatus of  claim 10 , wherein the dry powder formulation comprises a diketopiperazine and at least one active ingredient. 
     
     
         12 . The inhaler accessory apparatus of  claim 1 , wherein said differential pressure sensor detects a pressure drop measured in said inhaler and an absolute pressure sensor used in conjunction with the differential pressure sensor to adjust, if necessary, for atmospheric conditions before identifying the pressure drop. 
     
     
         13 . The inhaler accessory apparatus of  claim 1 , further comprising one or more of: a color detection sensor for sensing color of an inhaler cartridge or other medicament package loaded into the inhaler, an RFID reader for reading an RFID tag in a cartridge or other medicament package loaded in the inhaler, and image detection sensors capable of identifying characters, codes or textual information provided on the inhaler or the inhaler cartridge or other medicament package. 
     
     
         14 . The inhaler accessory apparatus of  claim 1 , further comprising a wireless transceiver over which data received from the at least two sensors is transmitted to a remote processing system. 
     
     
         15 . The inhaler accessory apparatus of  claim 14 , further comprising an electronic board and wherein the microprocessor, sensors and wireless transceiver are connected to and/or disposed on the electronic board. 
     
     
         16 . The inhaler accessory apparatus of  claim 1 , further comprising visual indicators or a display for showing differences between an idealized or predetermined inhalation parameters and the attained/performed inhalation maneuver of a user. 
     
     
         17 . The inhaler accessory apparatus of  claim 16 , wherein the visual indicators are a pass/fail, or green/red indicators to a user. 
     
     
         18 . A dry powder inhaler monitoring and detecting system, comprising:
 a dry powder inhaler;   a microprocessor,   a wireless transceiver, and   a first sensor for detecting information on pressure differential in areas or parts of said inhaler; and   a second pressure sensor for detecting signals generated from an inhaler when in use,   wherein the second pressure sensor communicates with the first sensor through a pressure equalizing channel; and   wherein said first and second pressure sensor generate at least one signal each which is processed in said microprocessor resulting in customized microprocessor output and wherein said microprocessor output generates a graphical display of pressure versus time curve characteristic of an inhalation maneuver performed by a user compared to a graph of predetermined profile values for the inhaler type.   
     
     
         19 . The dry powder inhaler monitoring and detecting system of  claim 18 , further comprising a remote processing system including a display, a wireless transceiver, and a microprocessor configured to report the pass or fail indication on the display in a graphical nature including indicating a threshold corresponding to the first sensor information detected and user inhalation data corresponding to the second sensor signals. 
     
     
         20 . The dry powder inhaler monitoring and detecting system of  claim 18 , further including a removable inhaler accessory apparatus comprising a body for mounting onto or connection with the inhaler and on which the microprocessor, wireless transceiver, and sensors are disposed. 
     
     
         21 . A method of monitoring and detecting accurate data valuable for inhaler user training, comprising:
 displaying an instruction to load a medicament in the inhaler;   reading medicament data relating to medicament information or inhaler information and relating data to a corresponding threshold;   displaying an instruction to begin an inhalation maneuver;   identifying pressure differential data during inhalation by user;   determining whether the inhaler user passed or failed the inhalation maneuver relating to meeting or exceeding the corresponding threshold or failing to attain the corresponding threshold.   
     
     
         22 . The method of  claim 21 , further comprising the step of transmitting and displaying an indication of whether user passed or failed the inhalation maneuver. 
     
     
         23 . The method of  claim 22 , wherein the transmitting and displaying step comprises displaying on a processing system such as a smart phone, tablet, computer or other wireless radio enabled device. 
     
     
         24 . The method of  claim 23 , wherein the transmitting and displaying step comprises transmitting the medicament data and the pressure differential data to the processing system via wireless transmission and displaying on said system a pressure vs. time curve along with a threshold corresponding to the medicament data. 
     
     
         25 . The method of  claim 24 , wherein the wireless transmission comprises Bluetooth®, Zigbee®; WiFi, SmartWave, Z-Wave, or a digital cellular network. 
     
     
         26 . The inhaler accessory apparatus of  claim 11 , wherein the at least one active ingredient comprises insulin or an insulin analog, sildenafil, avanafil, verdenafil, treprostinil, tadalafil, epinephrine, tetrahydrocannabinol and cannabidiol.