Controlling methods of a newly developed extra aortic counter-pulsation device using shape memory alloy fibers.

Diastolic counter-pulsation has been used to provide circulatory augmentation for short term cardiac support. The success of intra-aortic balloon pump (IABP) therapy has generated interest in long term counter-pulsation strategies to treat heart failure patients. The authors have been developing a totally implantable extra aortic pulsation device for the circulatory support of heart failure patients, using 150 µm Ni-Ti anisotropic shape memory alloy (SMA) fibers. These fibers contract by Joule heating with an electric current supply. The special features of our design are as follow: non blood contacting, extra aortic pulsation function synchronizing with the native heart, a wrapping mechanical structure for the aorta in order to achieve its assistance as the aortomyoplsty and the extra aortic balloon pump. The device consisted of rubber silicone wall plates, serially connected for radial contraction. We examined the contractile function of the device, as well as it controlling methods; the phase delay parameter and the pulse width modulation, in a systemic mock circulatory system, with a pneumatically driven silicone left ventricle model, arterial rubber tubing, a peripheral resistance unit, and a venous reservoir. The device was secured around the aortic tubing with a counter-pulsation mode of 1:4 against the heartbeat. Pressure and flow waveforms were measured at the aortic outflow, as well as its driving condition of the contraction phase width and the phase delay. The device achieved its variable phase control for co-pulsation or counter-pulsation modes by changing the phase delay of the SMA fibers. Peak diastolic pressure significantly augmented, mean flow increased (p<0.05) according to the pulse width modulation. Therefore the newly developed extra aortic counter-pulsation device using SMA fibers, through it controlling methods indicated its promising alternative extra aortic approach for non-blood contacting cardiovascular circulatory support.