Avalier Pharyngeal Reinforcement System 

How does the device work?

The device is a scaffold implanted into the pharynx (in-office procedure by ENT). It is made from temperature-sensitive material (expands in the presence of heat). The device mimics natural swallowing. As hot food enters the mouth, the oral opening expands. As food moves, the oral opening then contracts, pushing the food in a peristaltic motion. A side branch expands to fold the epiglottis over the trachea (windpipe), a mechanism often compromised in dysphagia that causes aspiration of food or liquid. In an alternate embodiment, the scaffold is made of current-sensitive material, where swallowing could be triggered by a small electrical pulse. 

What healthcare problem does it solve?

Dysphagia, the term for difficulty swallowing, affects 15% of the elderly (60 and up) and 60% of stroke patients--a whopping total of 6 million patients in the United States alone. Dysphagia is attributed to neurologic damage from aging, dementia, and stroke that disrupts one or multiple mechanisms in the complex swallowing process. Dysphagia seriously impacts physical and emotional well-being; it contributes malnutrition/dehydration and pneumonia, and it forces sufferers to drastically change eating habits. Treatments are a huge unmet need; physical/behavioral therapy only helps patients cope, while more effective methods (electrical stimulation, feeding tubes) are completely disruptive to patients' lives. 

Why should the device be commercialized?

The costs of dysphagia are spread throughout the healthcare chain. Patients are frequently readmitted to hospitals and stay twice as long--an additional 223,000 days/year, costing $547 million. Patients require closer care (in-home or nursing home) and extensive swallowing therapy ($200/hr). Even costs from dietary changes amount to $200/month. My competitive analysis found existing treatments to be inadequate, and an FTO search did not yield any prior art. I recognize the high get-to-market cost (R&D and trials) and regulatory hurdles (PMA), but within the context of this challenge, I think this product is a slam dunk for commercialization. 

What inspired you to design this device?

I was inspired by seniors in my life at risk for dysphagia and its morbidities (I myself can't imagine dying from not swallowing properly). My 85-year-old diabetic grandmother has neuropathies that could affect her swallowing. Through my job, I am exposed to frail and/or senile patients who neither have stamina nor cognitive abilities to keep up with the standard of care. Ultimately, I see my role as an engineer as being responsible for designing more elegant solutions (to problems like dysphagia) that must be centered around the patient. 

Submitted by: Nikhil Viswanathan 

Learn how to design disruptive connected health devices at BIOMEDevice San Jose December 7 & 8, 2016.