A Pulsatile-Flow Model for Intracardiac Surgical Device Development

Abstract

Percutaneous treatments for heart disease have created new challenges for both physicians and medical device developers and manufacturers. In order to deliver the highest-quality care to patients, developers and physicians must be able to more easily access the intracardiac environment during the initial phases of device development and while learning to implement new tools and methods. We have developed a pulsatile flow model (PFM), which simulates the intracardiac environment using a bellows-pump and closed fluid flow circuit. The PFM is also outfitted with video imaging and other sensors to provide real-time feedback to a user. The PFM was used to aid in the development of a catheter for the percutaneous treatment of mitral regurgitation via chordal cutting. Knowledge gained from tests with the PFM are now being used by a manufacturer to produce catheters, which would be appropriate for more in-depth trials in both animal and human models. The pulsatile flow model provide physicians and manufacturers of cardiac surgical devices a platform for increasing the efficiency of the development process as well as the physicians ability to better treat patients.