Cora valveless pulsatile rotary pump: new design and control.

For decades, research for developing a totally implantable artificial ventricle has been carried on. For 4 to 5 years, two devices have been investigated clinically. For many years, we have studied a rotary (but not centrifugal) pump that furnishes pulsatile flow without a valve and does not need external venting or a compliance chamber. It is a hypocycloidal pump based on the principle of the Maillard-Wankel rotary compressor. Currently made of titanium, it is activated by an electrical brushless direct-current motor. The motor-pump unit is totally sealed and implantable, without noise or vibration. This pump was implanted as a left ventricular assist device in calves. The midterm experiments showed good hemodynamic function. The hemolysis was low, but serious problems were encountered: blood components collecting on the gear mechanism inside the rotor jammed the pump. We therefore redesigned the pump to seal the gear mechanism. We used a double system to seal the open end of the rotor cavity with components polished to superfine optical quality. In addition, we developed a control system based on the study of the predicted shape of the motor current. The new design is now underway. We hope to start chronic experiments again in a few months. If the problem of sealing the bearing could be solved, the Cora ventricle could be used as permanent totally implantable left ventricular assist 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.

Biological evaluation of mechanical circulatory support systems in calves.

Data from animal experiments with mechanical circulatory support systems (MCSS) performed in Groningen and Marseille over the past years were used to obtain normal values of hematological, coagulation, rheological and blood chemistry parameters in calves. These parameters were divided between two groups: a limited number of parameters necessary to assess biocompatibility properties of MCSS quickly and a more extensive number of parameters suitable for more detailed biological evaluation of blood pumps. All applied tests can be examined in calf blood as well as in human blood. Parameters were selected on clinical relevance and usefulness for standardization procedures. The obtained data were compared with normal values in human beings derived from the literature.

First significant animal survival with a Wankel-type left ventricular assist device.

The authors' laboratory is developing a device for heterotopic left ventricular assistance. It consists of a titanium Wankel-type rotary pump, driven by an hermetically sealed electric motor. In our animal experiments, the motor-pump unit was implanted in the thoracic wall. The pump was connected to the left heart chambers by left atrial cannulation, and to the descending aorta. The motor was connected to the power and control unit by an electric wire through the skin. In this report, the authors describe the first significant animal survival with this system. Laboratory results were encouraging for hemolysis. The pump failed at 13 days due to a deposit of fibrin and blood cells in the gear housing. This problem was not surprising since similar events have been encountered with centrifugal devices. However, further design improvements should allow longer animal survival and clinical application.

Cora rotary pump for implantable left ventricular assist device: biomaterial aspects.

Our group is developing a left ventricular assist device based on the principle of the Maillard-Wankel rotative compressor: it is a rotary, not centrifugal, pump that produces a pulsatile flow. Stringent requirements have been defined for construction materials. They must be light, yet sufficiently hard and rigid, and able to be machined with high precision. The friction coefficient must be low and the wear resistance high. The materials must be chemically inert and not deformable. Also, the materials must be biocompatible, and the blood contacting surface must be hemocompatible. We assessed the materials in terms of physiochemistry, mechanics, and tribology to select the best for hemocompatibility (determined by studies of protein adsorption; platelet, leukocyte, and red cell retention; and hemolysis, among other measurements) and biocompatibility (determined by measurement of complement activation and toxicity, among other criteria). Of the materials tested, for short- and middle-term assistance, we chose titanium alloy (Ti6Al4V) and alumina ceramic (Al2O3) and for long-term and permanent use, composite materials (TiN coating on graphite). We saw that the polishing process of the substrate must be improved. For the future, the best coating material would be diamond-like carbon (DLC) or crystalline diamond coating.

Another way of pumping blood with a rotary but noncentrifugal pump for an artificial heart.

This article describes an alternative mode of pumping blood inside the body. The device is a non centrifugal, valveless, low speed rotary pump, electrically powered, based on Wankel engine principle. The authors developed an implantable electrical actuator resulting in a compact, sealed motor-pump unit with electrical and magnetic components insulated from fluids. The results in the flow curve and in the pumping action show some common points but also some basic differences compared to classical pulsatile pumps or centrifugal pumps. The blood coming from the atrium follows a continuous movement without any stop flow but with variations creating pulsatility. Ejection and filling of the pump are simultaneous. It is always an active filling. Hydraulic efficiency depends on clearance in the pumping chamber and outlet port pressure. A 60 cc device allows flows up to 8-9 liters. The implantable motor is cyclindrical in shape, has a moderate weight (490 grams) and presents a good efficiency (32% for a rotary speed of 90 rpm against a mean aortic pressure of 150 mm of Hg). The authors conclude that their device could be proposed after further experimental studies, as an LVAD for shortterm assistance with a good promise for permanent application.

Control of pulsatile rotary pumps without pressure sensors.

When ventricular assistance is achieved with a volumetric pump driven by an electric actuator, overpumping can cause venous collapse. To prevent this problem, pump speed must be monitored and controlled. The authors developed a regulatory system based on the current intensity signal from the electric motor. This signal is processed and compared with predicted values calculated according to a mathematical model at the beginning of each ejection phase. If a difference is detected, pump speed is adequately adjusted. The great advantage of this system is elimination of the need for an implantable pressure sensor. It requires a simple and ubiquitous electronic component, i.e., a resistor, that can be easily integrated into the motor control circuit and does not require calibration.

Experimental use of a semipulsatile rotary blood pump for cardiopulmonary bypass.

We tested our valveless pulsatile rotary blood pump (CORA) extensively in animals, but only as a temporary implantable left ventricular assist device. To expand the scope of future clinical applications, we recently undertook experiments to assess the feasibility of our pump for use in a standard cardiopulmonary bypass circuit. We conducted 4 experiments in adult sheep (body weight, 40 kg): 2 with CORA and 2 with the BioMedicus pump (BP) for comparison. In all experiments, a currently used extracorporeal circuit with reservoir, filter, and membrane oxygenator (Sorin monolith) was installed, and open chest extracorporeal circulation (ECC) was performed for 6 h. Hemodynamic performance and hemolysis were evaluated. CORA provided semipulsatile systemic flow at a level comparable to that of the BP. Free plasma hemoglobin levels were slightly higher with CORA, but the decrease in platelet count was the same for both devices. There was no significant difference in the extent of blood trauma. We conclude that CORA could be successfully used for ECC with an oxygenator. Negative pressure can be prevented by our specially designed control system.

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.

Study of left ventricular bypass using Wankel type semipulsatile blood pump.

The influence of the Wankel type semipulsatile left ventricular assistance on hemodynamics was investigated with a computer simulation and an animal experiment. A simulation circuit was constructed to express the circulatory system. A current source was added to create a semipulsatile blood pump. The left and right ventricles were replaced by variable compliances. Left heart failure was simulated by decreasing the amount of compliance change of the left ventricle. Under the condition of heart failure when semipulsatile assist flow increased, the mean aortic pressure (AoP), tension time index (TTI), and diastolic pressure time index (DPTI) increased, and the cardiac output, pulse pressure (PP), and pulsatility indicator (PI) decreased. In an animal experiment, a Wankel type blood pump was used in a calf. With the increase of the assist flow, AoP curves became less pulsatile, and PP and PI decreased in accordance, which was predicted by the numerical simulation.