Current anorectal sphincter manometry methods provide limited temporal and spatial information regarding the anorectal sphincter. The objective of this program is to complete the development of a manometry system using solid-state pressure sensors (Force Sensing Resistors) to replace the perfusion manometer sensors which are currently in use. This system will provide clinical diagnostic information currently not available.
The specific aims of the Phase II program, based on concept feasibility demonstrated in Phase I, are to: (1) Develop a solid sphincter probe which can monitor pressures simultaneously and rapidly at 512 discrete points throughout the anorectal sphincter; (2) Develop an electronic interface which is fast enough to observe the entire sphincter at 10 Hz to observe fast waves; (3) Develop software that both stores sphincter pressure data and provides real time graphic presentations; (4) Integrate the various components into a practical clinical system; (5) Verify system integrity with a complete phantom trial; and (6) Verify system suitability by preliminary clinical trials. This solid state manometry system will provide the clinician with a higher resolution, real time method for quantifying sphincter function.
