Patrick Havlik

TiN coating : surface characterization and haemocompatibility

The left ventricular assist device under consideration is based on the principle of the Maillard-Wankel rotary pump. The construction materials must meet stringent requirements. Titanium nitride was chosen for its surface properties and graphite for its bulk characteristics. The purpose of this study was to characterize the chemical vapour deposition titanium nitride coating via morphology, roughness, crystallinity, chemical composition, to report and discuss the results of in vitro haemocompatibility tests (protein adsorption, platelet retention, haemolysis) and to discuss physico-chemical and biological results. This chemical vapour deposition titanium nitride coating is well tolerated by the blood despite its surface irregularities, and appears as a good candidate material after improvements.

Physico-chemistry and cytotoxicity of ceramics: Part II Cytotoxicity of ceramics

General cytotoxicity was assayed for ceramic (Al2O3, ZrO2/Y2O3, AIN, B4C, BN, SiC, Si3N4, TiB4, TiC, TiN) diamond and graphite powders, using 3T3 Balb/c permanent cell lines. Neutral red test was carried out in order to establish cell viability. Further investigations were undertaken on human differentiated cells (human umbilical venous endothelial cells): cell behaviour (MTT assay, total cell protein content) and differentiation (immunofluorescence) were studied. In both cases, no cytotoxic effect has been noticed. All the impurities contained at low concentration in these powders do not seem to present any effect. The correlation which has been previously observed between cytotoxicity-cell culture response and blood haemolysis for polymers has not been established here for ceramic powders. We conclude that all the ceramic powders tested here and therefore the corresponding bulk ceramics or ceramic coatings do not induce any cytotoxic effect.

Blood haemolysis by ceramics

Ceramics are more and more frequently under consideration for construction of blood-contacting devices, i.e. cardiac valves or cardiac assist devices. This study evaluated the haemolysis eventually initiated in vitro by ceramic powders (Al2O3, ZrO2/Y2O3, AlN, B4C, BN, SiC, Si3 N4, TiB2, TiN, TiC), graphite and diamond. The chemical composition of the powders was studied by X-ray microprobe and various other methods, and BET specific areas were determined. The haemolysis was almost zero for all powders, except AlN which showed slight haemolysis and TiB2 which had high haemolytic power.

Haemocompatibility of Ti6A14V alloy.

Ti6A14V alloy has been mainly used as a biomaterial in the orthopaedic field. The present study describes the surface state of the Ti6A14V material and evaluates its in vitro haemocompatibility in terms of protein adsorption, platelet retention and haemolysis. The behaviour of the Ti6A14V alloy towards albumin and fibrinogen was compared to that of a reference medical-grade elastomer. The platelet retention test gave better results than those achieved with the elastomer. The haemolysis percentage of the alloy was almost zero. These results indicate that the Ti6A14V alloy is well tolerated by blood.

A New Model to Test Platelet Adhesion under Dynamic Conditions: Application to the Evaluation of a Titanium Nitride Coating

In order to evaluate under dynamic circumstances the in vitro platelet adhesion induced by rigid materials such as ceramic coatings deposited on selected substrates, a new model simulating a tube has been designed. In vitro platelet adhesion was assessed with this new model: the material was titanium nitride (TiN) deposited on Ti6A14V (TA6V) titanium alloy by a physical vapor deposition (PVD) process. The results were compared to those obtained with complete titanium carbide (TiC) graphite tubes coated with TiN by a chemical vapor deposition (CVD) process. The difference observed (less than 25%) in favour of the new system, could be due to the better surface state of the construction materials of this system. In fact it is a systemic error. However TiN confirms its good performance as a blood-contacting biomaterial.

Physico-chemistry and cytotoxicity of ceramics: Part I – Characterization of ceramic powders

The morphology of Al2O3, ZrO2/Y2O3, AIN, B4C, BN, SiC, Si3N4, TiB2, TiC, TiN ceramic, graphite and diamond powders has been studied by scanning electron microscopy (SEM) and the specific area of each powder was determined with the BET method. X-ray diffraction (XRD) investigations have been carried out in order to evaluate the crystallinity and determine the constitutive phases. The chemical composition was assessed by classical chemical analyses and by X-ray microprobe; some powders were studied by the laser micro-Raman technique. Correlations have been established between all these results.

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.

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.

An Electrically-Driven Rotary Blood Pump Based on the Wankel Engine

Our laboratory is developing an implantable electrically-driven left ventricular assist device. The device consists of a rotary pump coupled with a brushless direct current (DC) motor. The pump, which is based on the Wankel engine principle and is composed of an elliptically-shaped rotor and a rotor housing, produces a semi-pulsatile flow without valves. The brushless DC motor directly drives the rotor shaft at low speeds ranging from 20 to 180 rotations per min (rpm). The pump-motor unit is connected to an external power and control unit by a thin electric cable. The current titanium alloy prototype has a stroke volume of 60 cm3 and is able to deliver a mean flow of over 81/min. In vivo left ventricular assist experiments have been performed. Four lasted longer than 10 days (maximum 13 days) and two lasted for 6 days. Moderate hemolysis and an initial decrease in platelet count were observed. Further improvement will be necessary to permit long-term use and reduce adverse effects on blood cells.

Current Advances in Cardiac Assist Devices

Under the heading of circulatory assist devices, we include systems designed for complete or partial cardiac replacement. We exclude agents acting on myocardial contraction and peripheral circulation as well as so-called counter-pulsation procedures using intra-aortic balloons which modify pressure rather than the flow rate.