The PNEUMAHALER™ Breath Activated Digital Inhaler (BDI)

The PNEUMAHALER BDI is a fully digital inhaler that integrates a removable drug cartridge with a pocket-sized housing. The drug cartridge fits snugly into the outside of the housing, the interior of which contains a differential pressure sensor, a Bluetooth-enabled microprocessor, and three AAA batteries. A key feature of the drug cartridge is the microfluidic ejector system that is embedded into the underside and mates with the outside of the device. The Bluetooth-enabled microprocessor controls dose delivery, dose counting (date and time stamping) and recording of inspiratory flow.

The microfluidic spray ejector enhances the delivery of drugs to the lungs by reliably creating droplets that lie within a predefined range of optimal sizes.

 

PNEUMAHALER eliminates the need for complex patient / device coordination by using a differential pressure sensor. The sensor initiates the ejector immediately upon sensing the onset of inhalation. The delivery system therefore requires no manual triggering to deliver medication. Moreover, unlike propellant driven MDIs, the droplets that the digital inhaler generates have little to no intrinsic velocity and are inspired into the lungs solely by the user’s incoming breath passing through the mouth tube. The inspired droplets ride on entrained air, which improves their deposition in the lungs. PNEUMAHALER, unlike numerous other pressurized metered dose inhalers, does not need priming.

 

A horizontal series of three small, user-visible LED lights and a small speaker within the handheld base help the user know how to correctly use the device, especially through voice coaching. Voice coaching can be disabled or enhanced, depending on the user’s needs. The device is portable, fits in the hand, and is similar in size to other multidose inhalers.

As the patient inhales through the device mouthpiece, the differential pressure sensor detects airflow by measuring the pressure drop.  When the required pressure decline is attained, the microprocessor activates the microfluidic ejection sprayer and all three LEDs illuminate green, indicating that dosing has started. The microprocessor then stops the sprayer at a preset time after initiation. PNEUMAHALER is designed to emit a positive chime sound after the dosing is complete, indicating to the user to begin holding their breath for 10 seconds. During this 10-second window, the three green lights blink intermittently to remind the user to continue to hold their breath. At the same time, voice commands instruct the patient to hold their breath for optimal drug deposition.

 

PNEUMAHALER’s cartridge design maintains constant drug product contact with the sprayer, eliminating the need for shaking and priming.

 

The microprocessor in PNEUMAHALER ensures the exact timing and actuation of the ejection sprayer. It also creates a unique time- stamp as to when each ejection happens and characterizes the user’s inhalation flow rate during the dose inhalation. A numerical display shows the number of doses that remain in the drug cartridge. PNEUMAHALER senses when a new cartridge has been inserted based on the unique electrical resistance of each individual cartridge. Dose counting and lockouts can be readily (pre-) programmed into the microprocessor.

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