P. Olegario

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

Detection and Avoiding Ventricular Suction of Ventricular Assist Devices

Continuous flow blood pumps, such as axial flow and centrifugal pumps, have been gaining interest as circulatory devices for total artificial hearts (TAHs) and a biventricular assist device (BVAD) because of their smaller size and simpler structure compared to pulsatile pumps. However, continuous flow pumps are more prone to suction of the left ventricle than pulsatile pumps are. Sudden increases in flow rate to meet changes in physiological demand, especially in the left pump, often cause ventricle suction. In this study, a control algorithm to prevent suction from occurring in the left ventricle by controlling the rotational speed of the right pump, instead of reducing the cardiac output of the left pump, was developed and investigated. The method was tested in acute animal experiments with calves. The results indicate that this proposed method is capable of preventing suction and could simultaneously maintain circulatory control. A key advantage of this control system is that flow rates can be maximized while avoiding ventricle suction conditions particularly when the circulatory system is unstable such as in a the first few days after operation

Evaluation of cardiac function based on ventricular pressure-volume relationships during assistance with a rotary blood pump.

Nowadays, a rotary blood pump can be used as not only for a bridge to transplantation (BTT) but also for a bridge to recovery (BTR) and a destination therapy (DT). In such cases, evaluation of the recovery level of the native heart provides useful information to improve the clinical strategy and decide adequate timing for removing of the RBP. In contrast, the indices for cardiac function have been studied. However, most of them do not consider the assistance with the RBP. In this study, we aimed at evaluating whether Emax, which is an index for cardiac function based on the pressure-volume relationships, is still valid during assistance with the RBP from an animal experiment. In the acute animal experiment with an adult goat, we measured pressure-volume (P-V) loops while cardiac function was normal, augmented or diminished. The experimental results revealed that there were typical differences in the shapes of P-V loops when the cardiac function was altered, and Emax can still be used as an index for the cardiac function even if the assistance with the RBP is ongoing

Indirect flow rate estimation of the NEDO PI Gyro pump for chronic BVAD experiments.

In totally implantable ventricular assist device systems, measuring flow rate of the pump is necessary to ensure proper operation of the pump in response to the recipient’s condition or pump malfunction. To avoid problems associated with the use of flow probes, several methods for estimating flow rate of a rotary blood pump used as a ventricular assist device have been studied. In the present study, we have performed a chronic animal experiment with two NEDO PI gyro pumps as the biventricular assist device for 63 days to evaluate our estimation method by comparing the estimated flow rate with the measured one every 2 days. Up to 15 days after identification of the parameters, our estimations were accurate. Errors increased during postoperation days 20 to 30. Meanwhile, their correlation coefficient r was higher than 0.9 in all the acquired data, and estimated flow rate could simulate the profile of the measured one.

Simulation of Atrial Wall Suction in a Continuous Flow Total Artificial Heart Model

An existing mathematical model of the cardiovascular system was modified by replacing the ventricles of the natural heart with two rotary blood pumps to investigate the problem of atrial wall suction in a continuous flow total artificial heart system and provide preliminary data for the implementation of an anti-suction control algorithm with quicker response. The responses of left atrial pressure to changes in right pump output were investigated through computer simulations using the modified model. The results were then compared with actual data from a prior acute animal experiment with a healthy mature goat performed to obtain data on pulmonary circulation dynamics and to determine the conditions that lead to atrial wall suction. The simulation results showed significant agreement with the animal experiment data with regards to left atrial pressure response to changes in right pump speed. Atrial wall suction was also successfully simulated using this model

Evaluation of Flow Rate Estimation Method for Rotary Blood Pump with Chronic Animal Experiment

Rotary blood pumps are expected to be used as an implantable ventricular assist device (VAD). In the VAD system, flow rate is important for monitoring of the state of a recipient and for automatic control to maintain appropriate blood perfusion. To obtain flow rate of the pump without any sensors, we proposed a method of estimating flow rate with supplied power and rotational speed using a time series model. To evaluate the accuracy of the proposed estimation method from the aspect of long-term use, we implanted NEDO PI Gyro pumps in a calf and performed a chronic animal experiment. Flow rate, supplied power and rotational speed were measured until post operation day (POD) 63, and the estimated flow rate was compared with the measured one. We confirmed that waveforms of the measured flow rate was sufficiently similar to the measured one, and correlation between them was higher than 0.9 in all the datasets. On the other hand, the root mean square error increased after 15 days. This error was probably due to the change in physiological condition, the operating point of the pump, or mild intima formation

Dynamic response of the pulmonary circulation in a continuous flow artificial heart system

Pulmonary circulation dynamics is important when considering bi-ventricular assist devices (BiVAD) or total artificial heart (TAH) systems and in investigating the mechanism of atrial collapse in order to design better control algorithms. In this study, we investigated pulmonary circulation dynamics in a continuous flow artificial heart system by performing acute tests on a mature goat. By varying the right pump speed, we were able to observe the dynamic response of the left atrial pressure (LAP) and simulate conditions that result in atrial suction. The results showed a time constant characteristic of a compliance lag in LAP response to changes in right pump output in the TAH configuration. These results may prove useful in the design of a new mock circulatory system that incorporates the dynamics of the pulmonary circulation, and in the improvement of existing control algorithms that prevent atrial wall collapse.Pulmonary circulation dynamics is important when considering bi-ventricular assist devices (BiVAD) or total artificial heart (TAH) systems, and in investigating the mechanism of atrial suction in order to design better control algorithms. In this study, we investigated pulmonary circulation dynamics in a continuous flow artificial heart system by performing acute tests on a mature goat. By varying the right pump speed, we were able to observe the dynamic response of the left atrial pressure (LAP) and simulate conditions that result in atrial suction. We were able to measure the time constant of the LAP response to changes in right pump output in the TAH configuration. These results may prove useful in the design of a new mock circulatory system that incorporates the dynamics of the pulmonary circulation, and in the improvement of existing control algorithms to prevent atrial wall suction.

Prevention of left atrial wall suction in a continuous-flow total artificial heart by controlling right pump output

One of the problems in continuous-flow total artificial heart control is atrial wall suction. In this study we developed a control algorithm which uses the right pump to prevent left atrial wall suction from occurring. Results of in vitro and in vivo tests indicate that prevention of left atrial wall suction is possible using this method and that it can be performed simultaneously with physiological control of the artificial heart.

Estimation of pressure head and flow rate in a continuous-flow artificial heart-in vivo evaluation

Instead of direct measurement of pressure head and flow rate of a centrifugal blood pump, the authors previously proposed a method of estimating these measurements. In this study, to ascertain the adequacy of the proposed method, an acute animal experiment was carried out using an adult goat equipped with an artificial heart consisting of two centrifugal pumps. The results indicated that the ARX model identified even in a mock circulation could estimate flow rate in the recipient accurately enough, although estimation accuracy of pressure head was not high.

In vivo evaluation of pressure head and flow rate estimation in a continuous-flow artificial heart

To avoid using sensors with low biocompatibility and low durability in implantable TAH systems, the authors previously proposed a new method for estimating instantaneous values of flow rate and pressure head on the basis of voltage, current and rotational speed in a motor driven centrifugal pump. The previous in vitro experiments showed that the proposed estimator could automatically compensate for the effect of the change in blood viscosity on the estimation accuracy by employing two kinds of auto-regressive exogenous model. In this study, validity and reliability of this estimation method were ascertained in an acute animal experiment. In the experiment, two centrifugal blood pumps were implanted into an adult goat as a total artificial heart. Results of estimation were compared with true values when blood viscosity was changed by injecting physiological saline. The results indicated that the system could successfully estimate pressure head by compensating the change of viscosity although the estimation accuracy of the in vivo estimation was not so high as that of the previous in vitro tests.