Kouichi Tabayashi

Development of an Artificial Myocardium using a Covalent Shape-memory Alloy Fiber and its Cardiovascular Diagnostic Response

The authors have been developing a newly-designed totally-implantable artificial myocardium using a covalent shape-memory alloy fibre (Biometalreg, Toki Corporation), which is attached onto the ventricular wall and is also capable of supporting the natural ventricular contraction. This mechanical system consists of a contraction assistive device, which is made of Ti-Ni alloy. And the phenomenon of the martensitic transformation of the alloy was employed to achieve the physiologic motion of the device. The diameter of the alloy wire could be selected from 45 to 250 mum. In this study, the basic characteristics of the fiber of 150 mum was examined to design the sophisticated mechano-electric myocardium. The stress generated by the fiber was 400 gf under the pulsatile driving condition (0.4W, 1 Hz). Therefore it was indicated that the effective assistance might be achieved by using the Biometal shape-memory alloy fiber

Deterministic chaos in the hemodynamics of an artificial heart

To analyze the hemodynamic parameters during prosthetic circulation as an entity, non linear mathematical techniques were used. To compare natural and prosthetic circulation, two pneumatically actuated ventricular assist devices were implanted as biventricular bypasses in chronic animal experiments using adult goats to consitute the biventricular bypass complete prosthetic circulation model with ventricular fibrillation. After implantation, these goats were placed in a cage and extubated after waking. All hemodynamic parameters with the natural circulation without biventricular bypass pumping, and the artificial circulation with biventricular bypass pumping under ventricular fibrillation were recorded under awake conditions. By the use of a non linear mathematical technique, the arterial blood pressure waveform was embedded into a four dimensional phase space and projected into three dimensional phase space. The Lyapunov numeric method is used as an adjunct to the graphic analysis of the state space. A phase portrait of the attractor showed a high dimension complex structure, with three dimensional solid torus suggesting deterministic chaos during natural circulation. However, a simple attractor, such as a limit cycle attractor, was observed during artificial circulation. Positive Lyapunov exponents during artificial circulation suggest the lower dimensional chaotic system. Thus, hemodynamic parameters during prosthetic circulation must be carefully controlled when unexpected stimuli are fed from outside.

STRANGE HEMODYNAMIC ATTRACTOR PARAMETER WITH 1/R TOTAL ARTIFICIAL HEART AUTOMATIC CONTROL ALGORITHM

To evaluate the automatic control algorithm of the total artificial heart (TAH) as an entity, and not just as parts, a non-linear mathematical analyzing technique including chaos theory was utilized. Chronic experiments on the biventricular bypass type artificial heart implantation were performed in healthy adult goats after the natural ventricles were removed. Hemodynamic time series data were recorded under the awake standing condition with TAH 1/R and fixed driving. Time series data were recorded on a magnetic tape and analyzed on a personal computer system with an A-D converter. Using the nonlinear mathematical technique, the time series data were embedded into the phase space and the Lyapunov numerical method was carried out for the quantitative evaluation of the sensitive dependence on the initial condition of the reconstructed attractor. Calculation of the largest Lyapunov exponents suggested that the reconstructed attractor of the left pump output during TAH 1/R control was a larger dimensional strange attractor, a characteristic pattern of deterministic chaos. A total system indicating chaotic dynamics was thought to be a flexible and intelligent control system. Thus, our results suggest that 1/R TAH control may be suitable for the biventricular assist type total artificial heart.

Sensorless control for a sophisticated artificial myocardial contraction by using shape memory alloy fibre

The authors have been developing an artificial myocardium, which is capable of supporting natural contractile function from the outside of the ventricle. The system was originally designed by using sophisticated covalent shape memory alloy fibres, and the surface did not implicate blood compatibility. The purpose of our study on the development of artificial myocardium was to achieve the assistance of myocardial functional reproduction by the integrative small mechanical elements without sensors, so that the effective circulatory support could be accomplished. In this study, the authors fabricated the prototype artificial myocardial assist unit composed of the sophisticated shape memory alloy fibre (Biometal), the diameter of which was 100 microns, and examined the mechanical response by using pulse width modulation (PWM) control method in each unit. Prior to the evaluation of dynamic characteristics, the relationship between strain and electric resistance and also the inditial response of each unit were obtained. The component for the PWM control was designed in order to regulate the myocardial contractile function, which consisted of an originally-designed RISC microcomputer with the input of displacement, and its output signal was controlled by pulse wave modulation method. As a result, the optimal PWM parameters were confirmed and the fibrous displacement was successfully regulated under the different heat transfer conditions simulating internal body temperature as well as bias tensile loading. Then it was indicated that this control theory might be applied for more sophisticated ventricular passive or active restraint by the artificial myocardium on physiological demand.

Morphological Approach for the Functional Improvement of an Artificial Myocardial Assist Device using Shape Memory Alloy Fibres

The authors have been developing a mechano-electric artificial myocardial assist system (artificial myocardium) which is capable of supporting natural contractile functions from the outside of the ventricle without blood contacting surface. In this study, a nano-tech covalent type shape memory alloy fibre (Biometal, Toki Corp, Japan) was employed and the parallel-link structured myocardial assist device was developed. And basic characteristics of the system were examined in a mechanical circulatory system as well as in animal experiments using goats. The contractile functions were evaluated with the mock circulatory system that simulated systemic circulation with a silicone left ventricular model and an aortic afterload. Hemodynamic performance was also examined in goats. Prior to the measurement, the artificial myocardial assist device was installed into the goats thoracic cavity and attached onto the ventricular wall. As a result, the system could be installed successfully without severe complications related to the heating, and the aortic flow rate was increased by 15% and the systolic left ventricular pressure was elevated by 7% under the cardiac output condition of 3L/min in a goat. And those values were elevated by the improvement of the design which was capable of the natural morphological myocardial tissue streamlines. Therefore it was indicated that the effective assistance might be achieved by the contraction by the newly-designed artificial myocardial assist system using Biometal. Moreover it was suggested that the assistance gain might be obtained by the optimised configuration design along with the natural anatomical myocardial stream line.

Development of total artificial heart with economical and durability advantages.

To develop a total artificial heart (TAH) pump system, we created a design paying particular attention to durability and cost. We adopted a pneumatically driven sac type artificial heart, where the configuration of the sac was decided according to the methodology of flow visualization. Its configuration is almost round to achieve as little stagnation as possible and a low turbulent flow. The main body of the sac was made using polyvinyl chloride (PVC) paste. The paste was poured into an external mold, and heated in a hot air drying oven. Coating was performed using polyurethane. The basic performance of this pump system was tested using a model circulation circuit, and a fitting study through acute animal experiment, using a healthy adult goat, was carried out. As for the TAH produced experimentally, a pump output exceeding 5.0 l/min in the model circulation circuit was provided. Implantation in the internal pleural cavity of a healthy adult goat, 55 kg in weight, proved possible and quite easy in comparison. It is thought that a more refined design in the connector part is desirable. Furthermore, a chronic experiment with the TAH will be carried out, and examination will need to be repeated in the future.

Fluctuations of the Hemodynamic Derivatives During Left Ventricular Assistance Using Oscillated Blood Flow

To analyze the autonomic nervous system during left heart bypass with a vibrating flow pump (VFP), fluctuations in hemodynamic derivatives were evaluated by the spectral analysis method using fast fourier transform methodology. After the left pleural cavity was opened through the fourth intercostal space under general anesthesia, a VFP was implanted as the left heart bypass device in chronic animal experiments using 3 healthy adult goats. Hemodynamic parameters with and without VFP assistance were recorded on magnetic tape in awake animals and were analyzed by computer through an analog to digital convertor. Power spectral analysis was performed on a beat-to-beat basis for the evaluation of the fluctuations. During left heart bypass with the VFP, Mayer wave fluctuations were decreased significantly although respiratory waves were not changed significantly. These results suggest that sympathetic nervous system modulation was changed under the influences of the left heart bypass with VFP. By using this analysis methodology, truly physiologic ventricular assistance may be achieved.

Assessment of synchronization measures for effective ventricular support by using the shape memory alloy fibred artificial myocardium in goats

Thromboembolic and haemorrhagic complications are the primary causes of mortality and morbidity in patients with artificial hearts, which are known to be induced by the interactions between blood flow and artificial material surfaces. The authors have been developing a new mechanical artificial myocardial assist device by using a sophisticated shape memory alloy fibre in order to achieve the mechanical cardiac support from outside of the heart without a direct blood contacting surface. The original material employed as the actuator of artificial myocardial assist devices was 100um fibred-shaped, which was composed of covalent and metallic bonding structure and designed to generate 4–7 % shortening by Joule heating induced by the electric current input. In this study, we focused on the synchronization of the actuator with native cardiac function, and the phase delay parameter was examined in animal experiments using Saanen goats. Total weight of the device including the actuator was around 150g, and the electric power was supplied transcutaneously. The device could be successfully installed into thoracic cavity, which was able to be girdling the left ventricle. The contraction of the device could be controlled by the originally designed microcomputer. The mechanical contraction signal input had been transmitted with the phase delay of 50–200 msec after the R-wave of ECG, and hemodynamic changes were investigated. Cardiac output and systolic left ventricular pressure were elevated with 20% delay of cardiac cycle by 27% and 7%, respectively, although there was smaller difference under the condition of the delay of over 30%. Therefore, it was suggested that the synchronization measures should be examined in order to achieve sophisticated ventricular passive/active support on physiological demand.

Application of a shape memory alloy for internal artificial organs

Shape memory alloy (SMA) is an actuator with high efficiency, and for this reason, SMA is suitable for totally implantable artificial internal organs. We have thought about the various possible applications, and one is an artificial sphincter. Many patients with cancer have a stoma, with which control of excretion is, of course, difficult. It limits the quality of life (QOL) of patients with stomata. If there is a sphincter for the stoma, control becomes possible. Therefore, an artificial anal sphincter was developed. Energy will be supplied by the use of a transcutaneous energy transmission system (TETS). The energy is used to raise the temperature and this becomes the drive energy in the SMA. This system can achieve very high efficiency; therefore, this actuator may be suitable for artificial internal organs. This system is currently in the stage of animal experimentation. By opening and shutting an artificial anal sphincter, excretion becomes possible. Application of this totally implantable system to artificial myocardium is considered in this article. SMA thread was sewn together, and the artificial myocardium was applied to the outside of a heart. For improvement of the cooling time, Peltier elements were adopted in this artificial myocardium. By the use of Peltier elements, rapid cooling becomes possible. Using this artificial myocardium, cardiac contraction may be assisted. In this way, various applications of the SMA are being considered in Tohoku University.

Vagal nerve activity and the high frequency peak of the heart rate variability.

For the Quality of life (QOL) of patients with an artificial heart system, monitoring an information of the cardiovascular control system may be important. We have been evaluating the autonomic nervous system for that purpose. Recently, fluctuations in hemodynamic parameters including heart rate variability (HRV) were evaluated by means of spectral analysis and nonlinear mathematical analysis. Respiratory wavers in HRV were thought ro reflect ongoing information of the parasympathetic nerve activity. Is it true? In order to confirm this hypothesis, we recorded vagal nerve activity directly in the chronic animal experiments. Six healthy adult goats were anesthetized with Halothene inhalation and thoracotomy were performed by the fourth lib resection during mechanical ventilation. Arterial blood pressure, right and left atrial pressures were continuously monitored with the catheter insertion. Cardiac output was measured by the electromagnetic flowmeter attached to the ascending aorta. After the chest was closed, incision was made to the left neck and left vagal nerve was separated. Stainless steel electrodes were inserted into the vagal nerve and fixed by the plasticizer. After the incision was closed, the goats were transferred to the cage and extubated after waking. Hemodynamic parameters and vagal nerve activity were measured in the awake condition. The results showed that clear observation of the autonomic nerve discharges were embodied by this experimental system. The vagal nerve discharges were synchronized with heart beat and respiration. The vagal nerve tonus was significantly influenced by the hemodynamic alteration. However in some condition, the respiratory wave was not always consistent with tonus of the vagal nerve activity, thus suggesting that we should check another information to evaluate the parasympathetic tone. We must continue this study to evaluate an autonomic nerve during artifical heart circulation.