Development of the Marseilles pulsatile rotary blood pump for permanent implantable left ventricular assistance.

We have developed a low-speed, double-lobed hypocycloidal pump that furnishes a pulsatile flow without valves. The pump is coupled to a specially designed electric motor. The motor/pump unit is totally implantable and has been extensively tested in vitro and in vivo in animals. Because this pump is volumetric, it is necessary to control speed precisely to avoid overpumping. Our control system, which is based on analysis of the motor current wave form, can detect and prevent negative pressures before they occur. The physical properties and hemocompatibility of several construction materials have been studied to determine their suitability for clinical use. These materials include a graphite substrate, titanium nitrate surface coating, boric carbon, and amorphous diamond. The pumps currently being tested are made of titanium, but clinical versions will be made of composite materials selected from this preliminary study. In vivo testing of this pump confirmed its good hemodynamic performance, low hemolysis rate, and biocompatibility (i.e., low heat, noise, and vibration levels). Animal experiments were terminated after 15 days because of mechanical failure related to the accumulation of blood components on moving parts. A new pump in which the mechanism is completely sealed from the blood flow has been designed and will soon be tested. If this sealed design is effective, the pump should be ready for use as a permanent implantable ventricular assistance device.

Control of a rotary pulsatile cardiac assist pump driven by an electric motor without a pressure sensor to avoid collapse of the pump inlet.

Our ventricular assist device uses a valveless volumetric pump operating on the Maillard-Wankel rotary principle. It is driven by an electric motor and provides a semi pulsatile flow. At each cycle, blood is actively aspirated into the device, and overpumping results in collapse at the pump inlet. To prevent overpumping, it is necessary to ensure that pump intake does not exceed venous return. Poor long-term reliability rules out the use of current implantable pressure sensors for this purpose. To resolve this problem, we have developed a method of control based on monitoring of the intensity of electric current consumed by the motor. The method consists of real time monitoring of current intensity at the beginning of each pump cycle. A sudden change in intensity indicates underfilling, and motor speed is reduced to prevent collapse. The current consumed by the motor also depends on the afterload, but the form of the signal remains the same when afterload changes. After demonstrating the feasibility of this technique in a simulator, we are now testing it in animals. We were able to detect and prevent collapse due to overpumping by the cardiac assist device. This system also enables us to know the maximum possible assistance and to thus adapt assistance to the user.