Deep venous thrombosis among disaster shelter inhabitants following the March 2011 earthquake and tsunami in Japan: a descriptive study.

OBJECTIVES: A retrospective analysis of data collected during subject screening following Japan's March 2011 earthquake and tsunami was performed. We aimed to determine the incidence of deep venous thrombosis (DVT) among screened subjects and to identify risk factors associated with the development of DVT as independent variables. METHODS: Calf ultrasonography was undertaken in 269 subjects living in 21 shelters in Miyagi prefecture during the one-month period immediately following the March 2011 disaster. Information regarding the health and risk factors of subjects was collected by questionnaire and assessment of physical signs. RESULTS: Of the 269 evacuees screened, 65 (24%) met the criteria for calf DVT. We found lower limb trauma, reduced frequency of urination and sleeping in a vehicle to be independent positive predictors of DVT. CONCLUSIONS: Evacuees had an increased risk of developing DVT, associated with tsunami-related lower limb injury, immobility and dehydration.

Peristaltic hemodynamics of a new pediatric circulatory assist system for Fontan circulation using shape memory alloy fibers.

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.

A new control method depending on primary phase angle of transcutaneous energy transmission system for artificial heart.

A new control method for stabilizing output voltage of the transcutaneous energy transmission system for artificial heart is proposed. This method is primary side, is outside of the body, which is not depending on a signal transmission system from the implanted device. The impedance observed from primary side changes from inductive to capacitive and the output voltage decreases drastically when the output current is large and the coupling factor is higher than that of the optimal condition. In this case, the driving frequency should be changed to higher so that the phase angle of the primary impedance is zero degree. The preliminary examination showed that this control method can enhance the output voltage limit to twice and the feasibility of the primary side control.

Controlling methods of a newly developed extra aortic counter-pulsation device using shape memory alloy fibers.

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 150 µm 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<0.05) according to the pulse width modulation. Therefore the newly developed extra aortic counter-pulsation device using SMA fibers, through it controlling methods indicated its promising alternative extra aortic approach for non-blood contacting cardiovascular circulatory support.

Examination of mitral regurgitation with a goat heart model for the development of intelligent artificial papillary muscle.

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.

Structural design of a newly developed pediatric circulatory assist device for Fontan circulation by using shape memory alloy fiber.

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.

Template for preparation of papers for IEEE sponsored conferences & Symposia.

Rotary blood pumps which have contact-less suspension are small, durable and widely used for left ventricular assist devices (LVADs). In order to design a total artificial heart (TAH) with rotary blood pumps, two pumps one for each ventricle, are controlled independently. Some of the challenges for the development of a TAH includes the requirement of a small size and the anatomical fitting of inlets and outlets which should be arranged closely on the circumference in the same direction. And they should be combined into a unit. In this paper, a helical flow total artificial heart (HFTAH) combing two centrifugal pumps with helical inlet in face is proposed in order to achieve a smaller TAH. To examine the pump performance, a preliminary test model for left ventricle was built, the size of the pump was 69.0mm in diameter and 45.0mm height. The size of the impeller was 44.0mm in diameter and 23.0mm height including a 15.0mm-height hydrodynamic bearing. The pump was externally driven by a direct current motor. 5.0L/min flow rate against 100mmHg pressure difference was obtained, where the total power consumption was 5.0W, the system efficiency was 23% with a rotational speed of 2070rpm. In this system, maximum pressure head, flow rate and efficiency were 420mmHg, 15.0L/min and 26%, respectively. In acute animal experiments with three healthy adult goats, the total biventricular bypass assist system using the pumps was able to maintain the maximum aortic flow at approximately 5.0L/min, and the pulmonary arterial flow at approximately 4.6L/min, the mean aorta pressure was 105mmHg, and the mean pulmonary artery pressure was 51mmHg. The development of the control method is undergoing, and a driving system and the pump aiming at the chronic animal experiments will be developed.

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.

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 initial 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.

Fractal dimension of 40 MHz intravascular ultrasound radio frequency signals.

OBJECTIVE: Fully automatic tissue characterization in intravascular ultrasound systems is still a challenge for the researchers. The present work aims to evaluate the feasibility of using the Higuchi fractal dimension of intravascular ultrasound radio frequency signals as a feature for tissue characterization. METHODS: Fractal dimension images are generated based on the radio frequency signals obtained using mechanically rotating 40 MHz intravascular ultrasound catheter (Atlantis SR Plus, Boston Scientific, USA) and compared with the corresponding correlation images. CONCLUSION: An inverse relation between the fractal dimension images and the correlation images was revealed indicating that the hard or slow moving tissues in the correlation image usually have low fractal dimension and vice-versa. Thus, the present study suggests that fractal dimension images may be used as a feature for intravascular ultrasound tissue characterization and present better resolution then the correlation images.

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 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.

Effect of the alternative magnetic stimulation on peripheral circulation for regenerative medicine.

Regenerative medicine for patients with peripheral atherosclerosis attracts considerable attention around the world. However, ethical problems persist in gene therapy. This study evaluates the effect of alterative magnetic stimulation on peripheral circulation. The effect of magnetic stimulation as a medical treatment was examined using a thermograph for 11 healthy volunteers. The thermograph was used to measure the rise in skin temperature. The experimental results suggested an improvement in the peripheral circulation. The results of our study suggest the effectiveness of alternative magnetic stimulation on atherosclerosis. We intend to extend our study in order to establish a methodology for regenerative medical treatment for patients with peripheral atherosclerosis. Further, we wish to advance the current research in the field of angiogenesis.

Cardio-ankle vascular index (CAVI) for the monitoring of the atherosclerosis after heart transplantation.

Atherosclerosis has been reported to progress rapidly after heart transplantation. A quantitative diagnosis is required for the diagnosis of atherosclerosis after heart transplantation. In this study, we compared brachial-ankle pulse wave velocity (baPWV) and cardio-ankle vascular index (CAVI) for the diagnosis. The average values of both baPWV and CAVI in the seven cases after heart transplantation were found to be signif-icantly large in comparison to the average values of the normal healthy people of the same age group. When comparisons were made before and after the heart transplantation in a particular case, CAVI was stable and baPWV changed sharply. A lot of parameters such as blood pressure, blood volume, etc. have been reported to influence baPWV. The results of this study suggested that CAVI was a stable parameter in comparison to baPWV even after heart transplantation. Thus, CAVI may be useful in the diagnosis of arteriosclerosis after heart transplantation.

Chaos analysis of electro encephalography and control of seizure attack of epilepsy patients.

In order to evaluate the EEG of patients with epilepsy, chaos analysis was performed for the subdural EEG time series data. The chaos attractor was reconstructed in the phase space and the correlation dimension. KS entropy calculated from the Lyapunov exponents was evaluated. Before the seizure attack, the KS entropy showed a lower value when compared with the time series data recorded during healthy condition. The results of our study suggest that it is possible to predict the seizure attack by the chaos analysis of the EEG signal. Further, we aim at developing an automatic control system for predicting a seizure attack by the use of local cooling of the focus with Peltier elements.

An innovative approach to evaluate a cardiac function based on surface measurement.

Major function of the heart is to pump blood flow up to all tissues or organs in the body, and it is generally recognized that cardiac function under various diseased conditions are mainly represented by a relationship between blood flow and pressure inside of the heart. In this report, an original proposal of evaluation method on cardiac function is introduced through a simultaneous measurement of various points of cardiac muscular surface. An optical three-dimensional location sensor was employed to measure a displacement change of anatomically specific points on heart surface. Then, changes in strain in each regional surface area were quantitatively obtained. This result indicated similar tendency obtained from echocardiogram. It was also indicated that there was a difference in displacements and phrases between control and arrhythmia. Moreover, strain change in regional area was coincident with a contraction of natural heart. It was found that an attempt to superimpose the data of strain change onto the video images of natural heart was extremely helpful to understand a cardiac function visually.

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 (Biometal®, 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 250μm. In this study, the basic characteristics of the fiber of 150μm 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.

Quantitative evaluation of the effect of visually-induced motion sickness using causal coherence function between blood pressure and heart rate.

To evaluate the effect of visually-induced motion sickness on the human, blood pressure variability (BP) and heart rate variability (HR) of 51 normal subjects watching a 15min-long video image taken by a vibrating handy camera were analyzed. Not only coherence function (K/sup 2/) between BP and HR but also two causal coherence functions: K/sup 2//sub BP-->HR/ from BP to HR and K/sup 2//sub HR-->BP/ from HR to BP were introduced to divide causal linearity of the cardiovascular system regarded as a closed-loop system. K/sup 2/ represents total linearity of the system. K/sup 2//sub BP-->HR/ and K/sup 2//sub HR-->BP/ correspond to the baroreflex system and the mechanical hemodynamics, respectively. The results revealed that K/sup 2//sub BP-->HR/ at the Mayer wave-band (around 0.1 Hz) of the subjects prone to motion sickness decreased gradually and was significantly lower than that of the subjects not prone to in later scenes. This result has never been obtained from conventional methods dealing with a cardiovascular system as an open-loop system.

Dynamic response of the pulmonary circulation in continuous flow artificial heart systems.

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.

Miniature vibrating flow blood pump using a cross-slider mechanism for external shunt catheter.

The prototype of the miniature vibrating flow pump (VFP) is developed for the external shunt catheter. The cross-slider mechanism is applied to vibrate the tube, which causes the pumping effect. This mechanism results in successful development of the miniature and lightweight VFP. By the use of the prototype VFP, the experiment of the basic pump performance is made in detail based on the authorized procedure in the research field of fluids engineering. The typical H-Q curve of VFP, which is the relationship between the pump head and the flow rate, can be obtained. This result suggests that the miniature VFP developed here can be expected to be used as the booster pump for the external shunt catheter in clinical applications.

Automatic monitoring system for artificial hearts using self organizing map.

This study presents an automatic monitoring system for artificial hearts. The self organizing map (SOM) was applied to monitoring and analysis of an aortic pressure (AoP) signal measured from an adult goat equipped with a total artificial heart. In the proposed system, two different SOMs were used to detect and classify abnormalities in the measured AoP signal. In the first stage, an ordinary SOM, taught with only normal AoP data, was used for detection of abnormalities on the basis of the quantization error in the real-time monitoring task. In the second stage, a supervised SOM was used for classification of abnormalities. The supervised SOM can be regarded as an ordinary SOM with an extra class vector for solving the classification problem. The class vector is assigned to every node in the second SOM as an output weight learned according to Kohonen's learning rule. The effectiveness of detection and classification of abnormalities using these two SOMs was confirmed.