Swallowing difficulty, otherwise known as dysphagia, affects 1 in 25 adults in the US annually. Dysphagia is associated with a number of neurological and mechanical origins, but the specific diagnosis and cause of each patient is difficult to ascertain. Esophageal manometry focuses specifically on the mechanical spectrum, where dysphagia is examined under the wide breadth of esophageal motility disorders. This procedure obtains pressure and impedance measurements through a catheter and a series of swallow tests to isolate the area and severity of illness.
To avoid interference and confounded data, patients are only allowed minimal amounts of lidocaine and no other pain relief medications during the procedure. The manometry catheter is inserted into the nose, down the esophagus, and into the stomach to capture data along the full gastrointestinal tract. The patient will perform a series of standardized saline swallowing tests, including different positions (eg. sitting, laying down) and types of swallows (eg. rapid vs slow).
Existing catheters have alternating sensors: 36 internal pressure sensors spaced 1cm apart and 18 external impedance pressures spaced 2cm apart
The catheter connects to the Manoview software, which shows a heatmap of the swallow as it travels down the esophagus.
The sensors are able to assess the contractile activity (i.e. primary peristalsis) of the muscle along the entire gastrointestinal tract, allowing physicians to minimize the region of interest.
Diagnoses are made based on the widely accepted clinical metric: the Chicago Classification schema (v4.0).
The alternating sensors create an uneven texture. In combination with the relatively large diameter (4-6mm) for individuals with dysphagia, the current catheters create an uncomfortable and sometimes painful experience for patients.
Current catheters prioritize pressure over impedance, which has limited efficacy due to confounding variables. For instance, pressure can be more sensitive to gravity or weight in some testing positions. This can create a false positive, skewing the patient's diagnosis as well as worsen the classification schema.
Recent literature has revealed the value of impedance measurements over pressure measurements, indicating a need for a high-resolution impedance catheter.
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