Interactive Apparatus and Method for Real-Time Profiling of Inhalation Efforts

Abstract

Described herein are interactive apparatus and methods for sensing and measuring real-time characteristic patterns of a subject's use of a dry powder inhalation system. The devices can be used in a wired or wireless communication mode to communicate with a display to assess the subject's usage of the inhalation system, to evaluate the performance of the inhalation system and/or to detect the characteristics profile of a dry powder formulation emitted from the inhalation system in use.

We claim: 
     
         1 . A method of training a subject to properly use an inhalation system comprising:
 a) providing a subject with a dry powder inhaler with a mouthpiece and a cartridge for delivering a dry powder formulation and an attachable interactive training device to the dry powder inhaler having at least one sensor configured within the detachable device and the at least one sensor can detect at least one signal generated from the dry powder inhaler upon an inhalation and transmit the at least one signal to at least one external device in real time by wireless communication for analysis of the at least one signal to generate data for real-time display of an inhalation concurrently being performed by the subject;   b) monitoring the subject's inhalation on a display of the external device, wherein a time verses pressure curve is generated and shown on the display;   c) repeating the inhalation;   d) comparing the curves attained until a preferred flow profile for the subject is displayed so that maximal delivery of a dry powder formulation can be achieved.   
     
     
         2 . The method of training a subject of  claim 1 , wherein the inhalation is for a period of 4 to seconds. 
     
     
         3 . The method of training a subject of  claim 1 , wherein said at least one sensor is a pressure sensor, temperature sensor, sound sensor, or optical sensor. 
     
     
         4 . The method of training a subject of  claim 1 , wherein said at least one sensor is a microphone. 
     
     
         5 . The method of training a subject of  claim 1 , wherein the sensor detects at least one signal generated from said dry powder inhaler and transmits in real-time said at least one signal to at least one external device comprising a microprocessor by wireless communication for analysis of said at least one signal to generate a data set for real-time display of the inhalation maneuver concurrently being performed by said subject. 
     
     
         6 . The method of training a subject of  claim 5 , wherein said at least one signal is a sound signal. 
     
     
         7 . The method of training a subject of  claim 5 , wherein said at least one sensor is configured to further measure said at least one signal. 
     
     
         8 . The method of training a subject of  claim 1 , wherein said dry powder inhaler has a resistance value between about 0.065 (√kPa)/liter per minute and about 0.200 (√kPa)/liter per minute. 
     
     
         9 . A method of training a patient to properly monitoring an inhalation maneuver in real-time corresponding to characteristic patterns of a patient's use of a dry powder inhalation system, comprising:
 a) providing a dry powder inhaler to the patient, said dry powder inhaler includes
 a mouthpiece, a cartridge structurally configured for said dry powder inhaler, and an attachable interactive training device comprising at least one sensor attached to or within the mouthpiece and in communication with air conduits of said dry powder inhaler, wherein the at least one sensor detects at least one signal generated from said dry powder inhaler and transmits in real-time by wireless communication said at least one signal to at least one external device comprising a microprocessor for analysis of said at least one signal to generate data for real-time display of an inhalation maneuver concurrently being performed by the patient, 
   b) coaching the patient during the inhalation maneuver to take a deep breath for a period of 4 to 5 seconds and having the patient exhale normally thereafter, wherein a time verses pressure curve is generated on a display of the external device;   c) repeating and monitoring the patient's inhalation maneuver;   d) comparing the curves to attain a preferred flow profile for that individual compared to a control cure provide in the display so that maximal delivery of the dry powder formulation can be achieved.   
     
     
         10 . The method of training a patient of  claim 9 , wherein said at least one signal is derived from a pressure differential generated in said dry powder inhaler. 
     
     
         11 . The method of training a patient of  claim 9 , wherein the at least one signal is a sound signal. 
     
     
         12 . The method of training a patient of  claim 9 , wherein said at least one sensor is a pressure sensor, temperature sensor, sound sensor, or optical sensor. 
     
     
         13 . The method of training a patient of  claim 9 , wherein said unit dose cartridge comprises a dry powder for pulmonary delivery. 
     
     
         14 . The method of training a patient of  claim 9 , wherein the dry powder comprises diketopiperazine microparticles. 
     
     
         15 . The method of training a patient of  claim 9 , wherein the dry powder comprises at least one active ingredient. 
     
     
         16 . The method of training a patient of  claim 9 , wherein said dry powder inhaler has a resistance value between about 0.065 (√kPa)/liter per minute and about 0.200 (√kPa)/liter per minute. 
     
     
         17 . The method of training a patient of  claim 12 , wherein an analog to digital converter communicates at least one sound signal from the sound sensor to a microprocessor configured to analyze and process said at least one sound signal for said characteristic pattern. 
     
     
         18 . The method of training a patient of  claim 9 , wherein said at least one external device comprises an analog to digital converter. 
     
     
         19 . The method of training a patient of  claim 9 , wherein said at least one external device comprises a display device.