T. Fujimoto

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

Deformability of human red blood cells exposed to a uniform shear stress as measured by a cyclically reversing shear flow generator

Red blood cells (RBCs) suspended in a dextran solution were at first loaded with a uniform shear stress of 21, 43 and 64 Pa for the duration of 0, 10, 20, 30, 45 and 60 min, respectively, followed with measurement of the dynamic deformation in terms of stretching and recovery, using a cyclically reversing sinusoidal shear flow with the peak stress of 128 Pa at 2 Hz. The L/W value, where L and W were the major and minor axis length of the RBC images, was derived to compare the effects of the uniform shear stress level and the exposure time. The exposure to the uniform shear stress of 21 Pa for the duration of as long as 60 min caused statistically insignificant L/W change in comparison to the control RBCs with L/W of 4.6 +/- 0.1. The exposure to 43 and 64 Pa for longer than 45 and 20 min, respectively, induced statistically significant change in the maximal L/W when compared to that of 21 Pa (p < 0.05). The composition of the maximal L/W values varied depending on the stress level and exposure time; with 21 Pa, the majority of cells exhibited the maximal L/W larger than 4.0 and few cells less than 2.0, whereas with the increase in the stress level to 43 and 64 Pa, cells having less than 2.0 exceeded 50%. Cyclic reversing shear flow is a useful means to measure dynamic deformation capability of RBCs which may be sub-hemolytically sheared without lysis.

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.

Design improvement of the jellyfish valve for long-term use in artificial hearts.

In a previous communication, we reported a leaflet fracture in a Jellyfish valve that was incorporated into a blood pump, after a 312-day animal implant duration. Subsequent finite element analysis revealed that the fracture location was consistent with an area of maximum strain concentration. Therefore, the aim of this study was to improve the durability in the light of these findings. Based on the engineering analysis results, a new valve seat having a concentric ring of 0.5mm width, located at a radius of 7.0 mm, was designed and fabricated. Accelerated fatigue tests, conducted under the conditions recommended by ISO 5840, demonstrated that the durability of this new prototype was extended by a factor of 10, as compared to the original valve. Moreover, further finite element analysis indicated that the maximum equivalent elastic strain of the proposed new valve was reduced by 52.3% as compared to the original valve. Accordingly, it has been confirmed that the modified Jellyfish valve is suitable for use in long-term artificial hearts.

Feasibility of a TinyPump system for pediatric CPB, ECMO, and circulatory assistance: hydrodynamic performances of the modified pump housing for implantable TinyPump.

The TinyPump is a miniature centrifugal blood pump with an extremely small priming volume of 5 ml, allowing blood transfusion free cardiopulmonary bypass as well as extracorporeal membrane oxygenation in pediatric patients. In this study, a new pump housing with the angled inlet port (25 degrees toward impeller center with respect to the flow axis) was designed to optimize the pump displaced volume and to extend the application of the TinyPump to implantable support The fluid dynamic performance analysis revealed that the head pressure losses increased from 3 to 17 mm Hg in comparison with straight port design as the pump rotational speed increased from 2,000 to 4,000 rpm. This was probably caused by perturbed flow patterns at the site of the inlet bent port area and streamline hitting the off-center of the impeller. No significant effect on pumping efficiency was observed because of modification in inlet port design. Modification in the inflow and outflow port designs together with the drive mechanism reduces the height of the pump system, including the motor, to 27 mm yielding the displaced volume of 68 ml in comparison with 40 mm of the paracorporeal system with the displaced volume of 105 ml. Further analysis in terms of hemolytic as well as antithrombogenic performance will be carried out to finalize the housing design for the implantable version of the TinyPump.

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.

Influence of valve size on the hydrodynamic performance of the ATS valve

Cineradiography has revealed the presence of the “non-fully-open” phenomenon in patients with the ATS valve. Preliminary in vitro investigations have identified two contributing factors: the expanding space at the outlet of the valve, and the local flow in the pivot area. This further study was performed with the aim of elucidating these factors with respect to different sizes of the ATS valve. Three bileafet valves, ATS, CarboMedics (CM), and St. Jude Medical (SJM), with tissue annulus diameters of 25 and 29 mm, were studied. The hydrodynamic performance of the valves was tested at the mitral position of our own pulse duplicator. The opening angle was measured using a high-speed video camera. All the CM and SJM valves were able to open fully in these tests, whereas the 25-mm and 29-mm ATS valves opened to 75° and 82°, respectively, despite their design maximum of 85°. The ATS exhibited the smallest pressure drop of the 29-mm valves, and the SJM the smallest of the 25-mm valves. The incomplete opening of the ATS valve might be explained by the ability of its leaflets to align themselves with the divergent outlet flow, due to its unique open-pivot design. Such a feature would also exhibit a low pressure drop, as seen in the 29-mm valve. The smaller opening angle in the 25-mm valve, however, could be caused by the additional pivot-flow, which might cause greater deviation of the leaflets in the smaller valve, resulting in a higher relative pressure drop.

Comparison of the closing dynamics of mechanical prosthetic heart valves.

To compare the closing dynamics of mechanical tilting disk prosthetic heart valves (OmniScience 25 [OS25], Medtronic-Hall 25 [MH25], Bjork-Shiley Monostrut 29 [BS29] and bileaflet valves (CarboMedics 29 [GM29]) in the mitral position, an x-ray high speed video camera (XHVC) and a mechanical mock circulator were used. From the continuous images taken with the XHVC, the starting point of closing and the period during closing (PDC) were measured. Pressures and flow rate were recorded at 500 Hz synchronously with the XHVC. A pressure difference across the valves at the onset of closing (dpc) was newly introduced to compare the closing response. Using 60 and 100 bpm, the following results were obtained: 1) the CM29 had less PDC and maximum backflow rate than the BS29; 2) the dpc and the PDC at 100 bpm were larger than those at 60 bpm; 3) the dpc of the MH25 was the lowest; and 4) the PDC of the CM29 was the shortest. With regard to the effect of valve design on closing dynamics, it was shown that: 1) less momentum of inertia of the occluder and disk traveling angle resulted in lower dpc and shorter PDC, and 2) the higher the dpc and the PDC became, the larger the maximum backflow rate that was generated, and 3) low final closing speed will be achieved for small disk travelling angle ASAIO Journal 1997;43:M401-M404.

Effect of the elastic conditions around a stentless valvular bioprosthesis on opening behavior.

Stentless valvular bioprostheses have been used clinically for over 8 years and the excellent properties of the bioprostheses have been demonstrated in clinical studies. The present study examined how differing elastic conditions around the bioprosthesis at the aortic position affect the hydrodynamic characteristics of the bioprosthesis. Bioprosthesis implantation is typically performed using either the subcoronary or the full-root technique. These procedures for implanting a stentless prosthetic heart valve at the aortic root were hydrodynamically evaluated in a mock circulatory system. Forward flow rate was 11% greater with the subcoronary technique than with the full-root technique. In a high-speed video camera study, the orifice area at full opening was 12% larger for the subcoronary technique than for the full-root technique. Evaluation of bioprosthetic characteristics in terms of mechanical conditions is important when considering surgical options.