New mitral annular force transducer optimized to distinguish annular segments and multi-plane forces.

Limited knowledge exists about the forces acting on mitral valve annuloplasty repair devices. The aim of this study was to develop a new mitral annular force transducer to measure the forces acting on clinically used mitral valve annuloplasty devices. The design of an X-shaped transducer in the present study was optimized for simultaneous in- and out-of-plane force measurements. Each arm was mounted with strain gauges on four circumferential elements to measure out-of-plane forces, and the central parts of the X-arms were mounted with two strain gauges to measure in-plane forces. A dedicated calibration setup was developed to calibrate isolated forces with tension and compression for in- and out-of-plane measurements. With this setup, it was possible with linear equations to isolate and distinguish measured forces between the two planes and minimize transducer arm crosstalk. An in-vitro test was performed to verify the crosstalk elimination method and the assumptions behind it. The force transducer was implanted and evaluated in an 80kg porcine in-vivo model. Following crosstalk elimination, in-plane systolic force accumulation was found to be in average 4.0±0.1N and the out-of-plane annular segments experienced an average force of 1.4±0.4N. Directions of the systolic out-of-plane forces indicated movements towards a saddle shaped annulus, and the transducer was able to measure independent directional forces in individual annular segments. Further measurements with the new transducer coupled with clinical annuloplasty rings will provide a detailed insight into the biomechanical dynamics of these devices.