Bridge’s ergonomic handle design allows for one- or two-user operation and reduces overall procedure time for this first-of-its-kind asthma treatment.
The Asthmatx Alair Bronchial Thermoplasty delivers precisely controlled thermal energy to the airway wall, in order to reduce the frequency of asthma attacks. It is the first non-drug treatment for the 6 million severe asthmatics worldwide, and provides asthma control for years—not hours, like commonly-used drugs. The procedure is a step and repeat process, involving placement and subtle manipulations at 180 locations, so a key design requirement was to speed up the procedure by streamlining each step.
Asthmatx’s clinical trials system required two operators: one manipulating a catheter in a bronchoscope, the other operating a handle. This approach slowed the procedure, demanding communication between two operators to time the coordinated handle and catheter positions for each step.
Design research revealed single-user operation would significantly reduce procedure time, but at times the bronchoscopist would need three hands to do the job. The challenge was to find a solution that allowed a single hand to do two things at once. In a quest to optimize ergonomics and workflow, Bridge designers modeled many styles of grips that were taken out to users for evaluation. This process led to the development of a universal handle design that allows the device to be comfortably operated by either one or two users.
The design solution decreases procedure time, removing bottlenecks identified by user research. It offers the option of a single user or two users according to clinician preference. Note the single-user hand position allows the handle to rest in the cleft between thumb and index finger. It is then possible to simultaneously squeeze the handle to deploy the RF wire basket while manipulating the catheter with a pencil like grip in and out of the bronchoscope.
The handle and its mechanism are inherently simple, reliable, and low cost to manufacture. The final device was granted commercial FDA approval April 2010.