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We have been developing implantable esophagus devices to achieve dynamic assistance in food-taking function for the patients suffering from esophageal cancer. Promotion of the quality of life as well as the activity of daily lives of the patients with severe esophageal cancer so that the esophageal tubular restoration by stenting or gastroesophagotomy are often carried out in order to ameliorate self-digestive function. Some patients with those severe cancer have difficulty to make food deliver smoothly due to the lack of peristaltic motions in the lesion. In this study, we presented a new structure of an artificial esophagus which was capable of delivering foods from a mouth to stomach with a distributed mechanism. We examined the natural esophageal specimens in order to obtain a relationship between volume and pressure. Prior to the measurement of mechanical characteristics of the natural specimen, the portions of esophagus were freshly extracted from goats after the experiments. Then we modeled the characteristics of natural esophageal functions through a digestive process from the anatomical, biomechanical point of view and confirmed the functional distribution in the artificial esophagus that could drive the contents from proximal to distal. A new structural design for the proximal esophageal portion was also developed to achieve squeezing motion by using a shape memory alloy fiber as an actuator and its dynamic characteristics were tested.

Mechanical cardiac support by using artificial organs improves the circulatory condition in the patients with heart failure. However, the thrombotic and bleeding complications might be caused by the use of these artificial prosthetic internal organs because of their direct attachment with blood. We have been developing an implantable artificial myocardial assist device that can support the natural ventricular contraction from outside of the heart. A shape memory alloy fiber was employed for the implantable design of the myocardial assistance. In this study, we focused on the right ventricular assist by the artificial myocardium using shape memory alloy fibers. We fabricated a prototype of the right ventricular contraction support based on the hinge mechanism design with shape memory fibered actuators. Fundamental characteristics of the contractile effects of the design, as well as its deformation, were examined, and the hemodynamic changes were investigated in the acute animal experiments. As a result, the supporting depth from the ventricular wall increased to be 35 mm, and the volumetric assistance showed around 50 mL incremental assist by the changes in the displacement of the actuator.

The crystal grains rotate and slip, maintaining a state of equigranular crystal, in the process of super plasticity deformation. The functional anisotropic Ti-Ni-Cu shape memory alloy fiber was developed, in which this property of super plasticity was applied to trim the direction of fine grains for the designed motion. An idea to use super plasticity in order to derive the property of poly-crystal function materials is rare till now. The method is supposed to provides a way to operate the grain boundary that is a domain of micro or nano meter order directly. The application to other materials except SMA can be expected enough. The characteristics of the material and the result of application are as follows. 1. The material has a two directional shape memory effect of approx. 5 % tensile strain. 2. It is easy to design shape memory alloy actuators with its wide operational range of low stress and large strain. 3. The fiber of the material performed more than 8×108 times reciprocated elongation and contraction of 3 % tensile strain and 100 MPa stress. 4. A servo actuator can be easily made. The servo actuator uses the approximately linear stable electric resistance variation of the material corresponding to a shape-memory effect as a position sensor.

Fontan procedure is one of the common surgical treatments of congenital heart diseases. Patients with Fontan circulation have single ventricle in the systemic circulation with the total cavopulmonary connection. We have been developing a pulmonary circulatory assist device using shape memory alloy fibers for Fontan circulation with total cavopulmonary connection. It consisted of the shape memory alloy fibers, the diameter of which are 100 µm. The fibers could wrap the ePTFE conduit for Fontan TCPC connection from the outside. We designed the sequential motion control system for sophisticated pulmonary hemodynamics by the pulsatile flow generation. In order to achieve pulsatile flow assistance in pulmonary arterial system, we fabricated a mechanical structure by sequential contraction of shape memory alloy fibers. Then, we developed a sequential contraction controller for the assist system, which could reproduce the wall contractile velocity at 6.0 to 20.0 cm/sec. We examined hemodynamic characteristic of its function using a mock circulatory system, which consisted of two overflow tanks representing venous and pulmonary arterial pressures in Fontan circulation. As a result, the pulmonary circulation assist device with sequential contraction could achieve effective promotion of the pulsatility in pulmonary arterial flow.

Diastolic counter-pulsation has been used to provide circulatory augmentation for short term cardiac support. The success of intra-aortic balloon pump (IABP) therapy has generated interest in long term counter-pulsation strategies to treat heart failure patients. The authors have been developing a totally implantable extra aortic pulsation device for the circulatory support of heart failure patients, using 150μm Ni-Ti anisotropic shape memory alloy (SMA) fibers. These fibers contract by Joule heating with an electric current supply. The special features of our design are as follow: non blood contacting, extra aortic pulsation function synchronizing with the native heart, a wrapping mechanical structure for the aorta in order to achieve its assistance as the aortomyoplsty and the extra aortic balloon pump. The device consisted of rubber silicone wall plates, serially connected for radial contraction. We examined the contractile function of the device, as well as it controlling methods; the phase delay parameter and the pulse width modulation, in a systemic mock circulatory system, with a pneumatically driven silicone left ventricle model, arterial rubber tubing, a peripheral resistance unit, and a venous reservoir. The device was secured around the aortic tubing with a counter-pulsation mode of 1-4 against the heartbeat. Pressure and flow waveforms were measured at the aortic outflow, as well as its driving condition of the contraction phase width and the phase delay. The device achieved its variable phase control for co-pulsation or counter-pulsation modes by changing the phase delay of the SMA fibers. Peak diastolic pressure significantly augmented, mean flow increased (p

Fontan procedure is one of the common surgical treatment of congenital heart diseases. Patients with Fontan circulation have single ventricle in the systemic circulation with the total cavopulmonary connection. Pulmonary blood flow in the Fontan circulation is lower than in healthy subjects, and the central venous pressure may elevate. In this study, we developed a mechanical circulatory assist device for the extracardiac conduit for Fontan circulation and examined its driving method in the mock pediatric pulmonary circulatory system. We used shape memory alloy (SMA) fiber as an actuator of the device. The SMA actuator wrapped the extracardiac conduit between inferior vena cava and pulmonary artery. We designed two different types of the circulatory assist devices. We drove these devices in two different modes by the synchronized and sequential motions. The flow volume was 10mL/min against a load of 10mmHg, and the maximum contractile force indicated 60mmHg in the mock test. These results suggested the effective mechanical assistance for Fontan pulmonary circulation.

Annuloplasty for functional mitral or tricuspid regurgitation has been made for surgical restoration of valvular diseases. However, these major techniques may sometimes be ineffective because of chamber dilation and valve tethering. We have been developing a sophisticated intelligent artificial papillary muscle (PM) by using an anisotropic shape memory alloy fiber for an alternative surgical reconstruction of the continuity of the mitral structural apparatus and the left ventricular myocardium. This study exhibited the mitral regurgitation with regard to the reduction in the PM tension quantitatively with an originally developed ventricular simulator using isolated goat hearts for the sophisticated artificial PM. Aortic and mitral valves with left ventricular free wall portions of isolated goat hearts (n=9) were secured on the elastic plastic membrane and statically pressurized, which led to valvular leaflet-papillary muscle positional change and central mitral regurgitation. PMs were connected to the load cell, and the relationship between the tension of regurgitation and PM tension were measured. Then we connected the left ventricular specimen model to our hydraulic ventricular simulator and achieved hemodynamic simulation with the controlled tension of PMs.

Total cavopulmonary connection (TCPC) is commonly applied for the surgical treatment of congenital heart disease such as single ventricle in pediatric patients. Patients with no ventricle in pulmonary circulation are treated along with Fontan algorithm, in which the systemic venous return is diverted directly to the pulmonary artery without passing through subpulmonary ventricle. In order to promote the pulmonary circulation after Fontan procedure, we developed a newly designed pulmonary circulatory assist device by using shape memory alloy fibers. We developed a pulmonary circulatory assist device as a non-blood contacting mechanical support system in pediatric patients with TCPC. The device has been designed to be installed like a cuff around the ePTFE TCPC conduit, which can contract from outside. We employed a covalent type functional anisotropic shape memory alloy fiber (Biometal, Toki Corporation, Tokyo Japan) as a servo actuator of the pulmonary circulatory assist device. The diameter of this fiber was 100 microns, and its contractile frequency was 2-3 Hz. Heat generation with electric current contracts these fibers and the conduit. The maximum contraction ratio of this fiber is about 7% in length. In order to extend its contractile ratio, we fabricated and installed mechanical structural units to control the length of fibers. In this study, we examined basic contractile functions of the device in the mock system. As a result, the internal pressure of the conduit increased to 63 mmHg by the mechanical contraction under the condition of 400 msec-current supply in the mock examination with the overflow tank of 10 mmHg loading.

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.

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. Prior to the experiment, the myocardial streamlines were investigated by using a MDCT, and the design of artificial myocardial assist devices were refined based on the concept of Torrent-Guasp’s myocardial band theory. As the hydrodynamic or hemodynamic examination exhibited the remarkable increase of cardiac systolic work by the assistance of the artificial myocardial contraction in the originally designed mock circulatory system as well as in the acute animal experiments, the chronic animal test has been started in a goat. Total weight of the device including the actuator was around 150g, and the electric power was supplied percutaneously. The device could be successfully installed into thoracic cavity, which was able to be girdling the left ventricle. In the chronic animal trial, the complication in respect to the diastolic dysfunction by the artificial myocardial compression was not observed.

The authors have been developing a sophisticated artificial myocardium for the treatment of heart failure, which is capable of supporting contractile function from the outside of the ventricle. The purpose of this study was to construct the control methodology of functional assistance by an artificial myocardium using small active mechanical elements composed of shape memory alloy fibres (Biometal). In order to achieve a sophisticated mechanical support by using shape memory alloy fibres, the diameter of which was 100 microns, the mechanical response of the myocardial assist device unit was examined by using PID (Proportional-Integral-Derivative) control method. Prior to the evaluation of dynamic characteristics, the relationship between strain and electric resistance of the shape memory alloy fibre and also the inditial response of each unit were obtained in the electrical bridge circuit. The component for the PID control was designed for the regulation of the myocardial contractile function. An originally-designed RISC microcomputer was employed and the input or output signals were controlled by pulse width modulation method in respect of displacement controls. Consequently, the optimal PID 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 methodology could be useful for more sophisticated ventricular passive or active restraint by using the artificial myocardium on physiological demand interactively.

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 % by Joule heating induced by the electric current input. Prior to the experiment, the myocardial streamlines were investigated by using a MDCT, and the design of artificial myocardial assist devices were refined based on the concept of Torrent-Guasp’s myocardial band theory. As the hydrodynamic or hemodynamic examination exhibited the remarkable increase of cardiac systolic work by the assistance of the artificial myocardial contraction in the originally designed mock circulatory system as well as in the acute animal experiments, the chronic animal test has been started in a goat. Total weight of the device including the actuator was around 150g, and the electric power was supplied percutaneously. The device could be successfully installed into thoracic cavity, which was able to be girdling the left ventricle. In the chronic animal trial, the complication in respect to the diastolic dysfunction by the artificial myocardial compression was not observed. Systolic pressure and aortic flow waveforms were elevated by the assistance using the device contraction synchronously by around 5%. And blood pressure response against the increase of aortic pressure was investigated under the myocardial assisted condition in order to examine the vascular tone which was controlled by vagal nervous activity.

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.

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 goat's 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.

As the heart failure is caused by the decrease in the myocardial contraction, the direct mechanical myocardial assistance in response to physiological demand, that is, the synchronous support of the contractile function from outside of the heart, might be effective. The purpose of this study was to develop an artificial myocardium which was capable of supporting the cardiac contraction directly by using the shape memory alloy fibres based on nanotechnology. Some methodologies using novel devices other than the artificial hearts are proposed so far with severe heart disease. However, it was also anticipated that the decrease in cardiac functions owing to the diastolic disability might be caused by using those ‘static’ devices. Then, this study was focused on an artificial myocardium using shape memory alloy fibres with a diameter of 100 – 150 um, and the authors examined its mechanism in a mock circulatory system as well as in animal experiments using goats. Basic characteristics of the material were evaluated prior to the hydrodynamic or hemodynamic examination using a mock ventricular model. The results were as follows: a) The length of the structure was able to be adjusted so that the system could wrap the whole heart effectively. b) In the hydrodynamic study using the mock circulatory system, the myocardial system was able to pump a flow against the afterload of arterial pressure level. c) In the animal experiments, aortic pressure and flow rate were elevated by 7 and 15% respectively by the mechanical assistance of the artificial myocardium, which was driven synchronising with the electrocardiogram, and also, d) The anatomically-identical shape of the artificial myocardium might be more effective for the assistance. In conclusion, it was indicated that this controllable artificial myocardial support system was effective for the mechanical cardiac support for the chronic heart failure.

The authors have been developing a newly-designed totally-implantable artificial myocardium using a covalent shape-memory alloy fibre (Biometal#174;, 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#956;m. In this study, the basic characteristics of the fiber of 150#956;m was examined to design the sophisticated mechano-electric myocardium. The stress generated by the fiber was 400gf under the pulsatile driving condition (0.4W, 1Hz). Therefore it was indicated that the effective assistance might be achieved by using the Biometal shape-memory alloy fiber.

The authors have been developing an artificial myocardium using a sophisticated covalent shape memory alloy fibre, which is capable of assisting natural cardiac contraction from the outside of the ventricular wall. We applied engineering method based on robotics control and constructed the artificial myocardial assist system which might be able to regulate derangement and regenerative tensile force on the surface of heart. In this study, a design to surround the total heart has been established in order to refrain from the stress concentration by the mechanical assistance, and the hemodynamic performance of the artificial myocardial assist system were examined in a mock circulatory system as well as on animal experiments using goats. Basic characteristics of the shape memory alloy fibre unit were examined and the displacement control could be achieved under the condition of the different external temperature by feedback using the PID control. And also the increase of the external work of the goats left ventricular pressure-volume relationship were obtained by the assistance using an artificial myocardium with parallel-linked configuration, and therefore it was indicated that the effective ventricular mechanical support could be performed by the device.