An Intelligent 32-Site Esophageal Manometry System

Period of Performance: 09/28/2001 - 06/30/2002


Phase 1 SBIR

Recipient Firm

Integrated Sensing Systems, Inc.
Ypsilanti, MI 48198
Principal Investigator


This project will develop an innovative system for analyzing esophageal motility disorders, the most prevalent of which is gastrointestinal reflux disorder (GERD). GERD affects between 8-19 million Americans and accounts for $5 billion in drug sales annually. The proposed system will simplify technique, minimize patient discomfort, and improve the accuracy, reliability, and repeatability of diagnoses. Key components of the system include a high-performance, 32-site, solid-state esophageal catheter, a dedicated interface unit, and a sophisticated data analysis software package. Micromachined silicon (MEMS) capacitive pressure sensor technology, along with a patented, two-wire, multiplexed readout scheme maximizes data fidelity while maintaining a catheter diameter of less than 3mm (9Fr). The inclusion of 32 sensing sites along the catheter body eliminates the need to reposition the catheter during data collection. Collected data is fed to software for analysis and patient diagnosis through proprietary algorithms. The system reduces or eliminates error due to catheter movement, low-fidelity or ambiguous data points, inaccurate pressure waveform interpolation, inconsistent diagnoses, non-physiologic confounding variables, personnel subjectivity, and patient uncooperativeness. In addition to esophageal motility diagnosis, the developed technology is a suitable platform for cardiac, urinary, and other multipoint catheter systems requiring increased fidelity, reduced diameters, and intelligent data analysis. PROPOSED COMMERCIAL APPLICATIONS: The developed system will be useful for characterizing, diagnosing, and understanding esophageal motility disorders, both in academic/research and clinical environments. As a side benefit, commercialization of this device will lower the barriers to entry for other novel medical microdevices, both in terms of the regulatory pathways and in terms of an ability to generate interest and investments from medical product companies and venture capitalists.