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We aimed to evaluate the effectiveness of photoreactive 2-methacryloyloxyethyl phosphorylcholine (MPC) in inhibiting Candida albicans biofilm formation on polymethyl methacrylate (PMMA) and assess its mechanism and need for re-application by evaluating its interaction with salivary mucin and durability during temperature changes.PMMA discs were used as specimens. The MPC coating was applied using the spray and cure technique for the treatment groups, whereas no coating was applied to the control. The MPC treatment (MT) groups were further differentiated based on the number of thermal cycles involved (0, 1000, 2500, and 5000). The optical density was measured to assess mucin adsorption (MA). Contact angle (CA) was calculated to evaluate surface hydrophilicity. The presence of MPC components on the PMMA surface was assessed using X-ray photoelectron spectroscopy (XPS). C. albicans biofilms were evaluated qualitatively (scanning electron microscope images) and quantitatively (colony-forming units (CFUs)). Statistical analysis was conducted using two-way analysis of variance and Tukey's multiple comparison test.MA rate and CA increased significantly in the MT groups, which exhibited significantly fewer CFUs and thinner biofilms than those of the control group. Based on the XPS, MA, and CFU evaluations, the durability and efficacy of the MPC coating were considered stable up to 2500 thermal cycles. Additionally, a significant interaction was observed between mucin concentration and MPC efficacy.The photoreactive MPC coating, which was resistant to temperature changes for approximately 3 months, effectively prevented C. albicans biofilm formation by modifying surface hydrophilicity and increasing mucin adsorption.

Advancements in dental cements have considerably improved their bond strengths. However, high bond strength often makes the removal of restorations difficult. Thus, smart dental cements that show controllable bond strength are required. A conventional resin-modified glass-ionomer-cement demonstrated a significant reduction in the bond strength after current application. However, for this system, the ions in the cement are released into the oral cavity, resulting in a reduction of the electrical conductivity and in losses of the expected on-demand debonding property. Herein, the effects of immersion in 0.9 and 15% NaCl solutions on the electrical conductivity and debonding properties were investigated. The cement immersed in 0.9% NaCl solution from 1 to 28 days maintained similar bond strength reductions after current application, whereas that in 15% NaCl solution initially showed no bond strength reduction after 1 day but exhibited an increase in the bond strength reduction after immersion for 28 days.

A new CPC was developed in this study using a β-TCP powder mechano-chemically modified by ball-milling. The prototype CPC exhibits excellent fluidity for easy injection into bone defects; however, there is a risk of leakage from the defects immediately after implantation due to its high fluidity. The addition of poloxamer, an inverse thermoresponsive gelling agent, into CPC optimizes the fluidity. At lower temperatures, it forms a sol and maintains good injectability, whereas at the human body temperature, it transforms to a gel, reducing the fluidity and risk of leakage. In this study, the effects of poloxamer addition of 3, 5, and 10 mass% on the injectability, shape stability, and strength of the prototype CPC were evaluated. The calculated injectability of the prototype CPC pastes containing three different poloxamer contents was higher than that of the CPC paste without poloxamer for 15 min at 37 °C. Furthermore, the shape stability immediately after injection of the three CPC pastes with poloxamer was higher than that of the CPC paste without poloxamer. After 1 week of storage at 37 °C, the compressive strength and diametral tensile strength of the CPC compacts containing 10 mass% poloxamer were similar to those of the CPC compact without poloxamer. Additionally, the CPC compacts containing 10 mass% poloxamer exhibited clear plastic deformation after fracture. These results indicate that the addition of poloxamer to the prototype CPC could reduce the risk of leakage from bone defects and improve the fracture toughness with maintaining the injectability and strength.

The dentin-pulp complex is a unique structure in teeth that contains both hard and soft tissues. Generally, deep caries and trauma cause damage to the dentin-pulp complex, and if left untreated, this damage will progress to irreversible pulpitis. The aim of this study was to fabricate a layered cell sheet composed of rat dental pulp (DP) cells and odontogenic differentiation of pulp (OD) cells and to investigate the ability to regenerate the dentin-pulp complex in a scaffold tooth. We fabricated two single cell sheets composed of DP cells (DP cell sheet) or OD cells (OD cell sheet) and a layered cell sheet made by layering both cells. The characteristics of the fabricated cell sheets were analyzed using light microscopy, scanning electron microscope (SEM), hematoxylin-eosin (HE) staining, and immunohistochemistry (IHC). Furthermore, the cell sheets were transplanted into the subrenal capsule of immunocompromised mice for 8 weeks. After this, the regenerative capacity to form dentin-like tissue was evaluated using micro-computed tomography (micro-CT), HE staining, and IHC. The findings of SEM and IHC confirmed that layered cell sheets fabricated by stacking OD cells and DP cells maintained their cytological characteristics. Micro-CT of layered cell sheet transplants revealed a mineralized capping of the access cavity in the crown area, similar to that of natural dentin. In contrast, the OD cell sheet group demonstrated the formation of irregular fragments of mineralized tissue in the pulp cavity, and the DP cell sheet did not develop any hard tissue. Moreover, bone volume/tissue volume (BV/TV) showed a significant increase in hard tissue formation in the layered cell sheet group compared with that in the single cell sheet group (

In this study, we developed a new catheter-mounted micro-axial flow blood pump (MFBP) using a new miniature magnetic fluid shaft seal (MFSS). The prototype of the catheter-mounted MFBP had a maximum diameter of 8 mm and a length of 50 mm. The new MFSS composed a neodymium magnet ring, an iron ring, and a magnetic fluid particularly designed for the MFSS. The new MFSS had outer and inner diameters of 4.0 mm and 2.6 mm, respectively, and a length of 3.0 mm. The sealing pressure of the MFSS was calculated to be 432 mmHg using FEM (Finite Element Method) result; therefore, the MFSS had sufficient sealing pressure for the catheter-mounted MFBP. The friction loss of the MFSS included the friction owing to the viscosity of the magnetic fluid and the magnetic force between the iron ring and ring magnet. The total friction loss of the MFSS was 0.08-0.09 W in the pump operational speed range from 22,000 to 35,000 rpm. From the in vitro experimental results, the catheter-mounted MFBP using the MFSS had a pump output of 3 L/min. against a differential pressure of 60 mmHg, and the pump characteristics of the MFBP were almost the same as those of Impella 5.0.

The enhancement in the bonding strength of advanced dental cements has enabled long-lasting dental restorations. However, the high bonding strength can cause difficulty in removing these restorations. Therefore, "smart" dental cements with simultaneous strong bonding and easy on-demand debonding ability are required. A resin-modified glass-ionomer-cement (RMGIC) with an ionic liquid (IL) has demonstrated significant reduction in the bonding strength with current application (CA). This research investigates the effect of immersion in distilled water on the electric conductivity and bonding strength of RMGIC with and without an IL and CA. The RMGIC without the IL exhibited significant electric conductivity after immersion, and a significant decrease in bonding strength with CA. In comparison, the electric conductivity after immersion and the decrease in bonding strength with CA were greater for RMGIC with the IL. Thus, the feasibility of smart dental cements capable of electrically debonding-on-demand is indicated.

With improvement of bonding strength of recent dental cement, it is difficult nowadays to remove restorations without excessive force or vibration to tooth, occasionally resulting in damage of dentin, enamel, and dental root. Therefore, "smart" dental cement indicating strong bonding and easy debonding-on-demand simultaneously is required. In this research, resin-modified glass-ionomer-cement containing an ionic-liquid, tris(2-hydroxyethyl)methylammonium methylsulfate was produced, and the shear bonding strength before and after direct current application were evaluated. The prototype cement containing 15 to 20 mass% ionic-liquid indicated simultaneously no significant reduction of shear bonding strength from that of the original cement not containing ionic-liquid, and significant reduction of bonding strength to approximately 20% of that of the original cement after direct current application of more than 2 mmC/mm2. The prototype cement in this research demonstrated that the concept of smart dental cement electrically debonding-on-demand is feasible.

The authors have developed a β-tricalcium-phosphate (β-TCP) powder modified mechano-chemically through the application of a ball-milling process (mβ-TCP). The resulting powder can be used in a calcium-phosphate-cement (CPC). In this study, the effects of the powder-to-liquid ratio (P/L ratio) on the properties of the CPCs were investigated, and an appropriate P/L ratio that would simultaneously improve injectability and strength was clarified. The mβ-TCP cement mixed at a P/L ratio of 2.5 and set in air exhibited sufficient injectability until 20 min after mixing, and strength similar to or higher than that mixed at a P/L ratio of 2.0 and 2.78. Although the mβ-TCP cements set in vivo and in SBF were found to exhibit a lower strength than those set in air, it did have an appropriate setting time and strength for clinical applications. In conclusion, P/L ratio optimization successfully improved the strength of injectable mβ-TCP cement.

The prosthetic applications of titanium have been challenging because titanium does not possess suitable properties for the conventional casting method using the lost wax technique. We have developed a production method for biomedical application of porous titanium using a moldless process. This study aimed to evaluate the physical and mechanical properties of porous titanium using various particle sizes, shapes, and mixing ratio of titanium powder to wax binder for use in prosthesis production. CP Ti powders with different particle sizes, shapes, and mixing ratios were divided into five groups. A 90:10wt% mixture of titanium powder and wax binder was prepared manually at 70°C. After debinding at 380°C, the specimen was sintered in Ar at 1100°C without a mold for 1h. The linear shrinkage ratio of sintered specimens ranged from 2.5% to 14.2%. The linear shrinkage ratio increased with decreasing particle size. While the linear shrinkage ratio of Groups 3, 4, and 5 were approximately 2%, Group 1 showed the highest shrinkage of all. The bending strength ranged from 106 to 428MPa under the influence of porosity. Groups 1 and 2 presented low porosity followed by higher strength. The shear bond strength ranged from 32 to 100MPa. The shear bond strength was also particle-size dependent. The decrease in the porosity increased the linear shrinkage ratio and bending strength. Shrinkage and mechanical strength required for prostheses were dependent on the particle size and shape of titanium powders. These findings suggested that this production method can be applied to the prosthetic framework by selecting the material design.

Calcium phosphate cement (CPC) offers many advantages as a bone-substitution material. The objective of this study is to develop a new CPC that simultaneously exhibits fine injectability, a short setting time, and high strength. β-tricalcium phosphate (β-TCP, control) powder was ball-milled for 24 h to produce a new cement powder. The modified β-TCP after 24 h milling (mβ-TCP-24 h) exhibited excellent injectability even 1 h after mixing. The mechanical properties of the set cement (compact) were evaluated using compressive strength (CS) and diametral tensile strength (DTS) testing. The CS and DTS values of the mβ-TCP-24 h compacts were 8.02 MPa and 2.62 MPa, respectively, at 5 h after mixing, and were 49.6 MPa and 7.9 MPa, respectively, at 2 weeks after mixing. All the CS and DTS values of the mβ-TCP-24 h compacts were significantly higher than those of the control for the same duration after mixing. These results suggest that the mechano-chemically modified β-TCP powder dissolves rapidly and accelerates hydroxyapatite precipitation, which successfully shortens the cement setting time and enhances the strength. This study supports that mβ-TCP-24 h is a promising candidate for use in injectable CPCs with improved strength.

Objectives The objective of this study is to develop a Ti fibre knit block without sintering, and to evaluate its deformability and new bone formation in vivo. Material and Methods A Ti fibre with a diameter of 150 μm was knitted to fabricate a Ti mesh tube. The mesh tube was compressed in a metal mould to fabricate porous Ti fibre knit blocks with three different porosities of 88%, 69%, and 50%. The elastic modulus and deformability were evaluated using a compression test. The knit block was implanted into bone defects of a rabbit’s hind limb, and new bone formation was evaluated using micro computed tomography (micro-CT) analysis and histological analysis. Results The knit blocks with 88% porosity showed excellent deformability, indicating potential appropriateness for bone defect filling. Although the porosities of the knit block were different, they indicated similar elastic modulus smaller than 1 GPa. The elastic modulus after deformation increased linearly as the applied compression stress increased. The micro-CT analysis indicated that in the block with 50% porosity new bone filled nearly all of the pore volume four weeks after implantation. In contrast, in the block with 88% porosity, new bone filled less than half of the pore volume even 12 weeks after implantation. The histological analysis also indicated new bone formation in the block. Conclusions The titanium fibre knit block with high porosity is potentially appropriate for bone defect filling, indicating good bone ingrowth after porosity reduction with applied compression.

Porous titanium has long been desired as a bone substitute material because of its ability to reduce the stress shielding in supporting bone. In order to achieve the various pore structures, we have evolved a moldless process combined with a space holder technique to fabricate porous titanium. This study aims to evaluate which pore size is most suitable for bone regeneration using our process. The mixture comprising Ti powder, wax binder and PMMA spacer was prepared manually at 70 °C which depended on the mixing ratio of each group. Group 1 had an average pore size of 60 μm, group 2 had a maximum pore size of 100 μm, group 3 had a maximum pore size of 200 μm and group 4 had a maximum pore size of 600 μm. These specimens were implanted into rabbit calvaria for three and 20 weeks. Thereafter, histomorphometrical evaluation was performed. In the histomorphometrical evaluation after three weeks, the group with a 600 μm pore size showed a tendency to greater bone ingrowth. However, after 20 weeks the group with a pore size of 100 μm showed significantly greater bone ingrowth than the other groups. This study suggested that bone regeneration into porous titanium scaffolds is pore size-dependent, while bone ingrowth was most prominent for the group with 100 μm-sized pores after 20 weeks in vivo.

Severe anal incontinence is a socially incapacitating disorder and a major unresolved clinical problem that has a considerable negative impact on quality of life. In this study, we developed a new artificial anal sphincter using shape memory alloys (SMAs) in order to improve the quality of life of such patients and evaluated the influence of this sphincter on blood serum chemistry in animal experiments. The artificial anal sphincter was driven by two Ti-Ni SMA actuators sandwiching the intestine and was implanted in three female goats. Blood was collected from the jugular vein on days 1 and 4; at weeks 1 and 2; and at months 1, 2, and 3, postoperatively. Biochemical parameters including total protein, albumin, total bilirubin, aspartate amino-transferase, blood urea nitrogen, creatinine, and C-reactive protein were examined. The time courses of total bilirubin and aspartate amino transferase of the three goats were within the baseline levels after 1 week of implantation and remained normal, demonstrating no liver function complications. The blood urea nitrogen and creatinine levels remained within the normal range, indicating no renal function complications. The total protein and albumin fluctuated within the normal range throughout the duration of this study. In these goats, it was also found that the level of C-reactive protein did not increase and that there was no stricture of the intestine where the artificial sphincter was attached. Our findings indicate that the artificial sphincter SMA demonstrated no adverse influence on blood serum chemistry and exhibited an effective system performance.

To overcome the drive shaft seal and bearing problem in rotary blood pumps, a hydrodynamic bearing, a magnetic fluid seal, and a brushless direct current (DC) motor were employed in an axial flow pump. This enabled contact-free rotation of the impeller without material wear. The axial flow pump consisted of a brushless DC motor, an impeller, and a guide vane. The motor rotor was directly connected to the impeller by a motor shaft. A hydrodynamic bearing was installed on the motor shaft. The motor and the hydrodynamic bearing were housed in a cylindrical casing and were waterproofed by a magnetic fluid seal, a mechanically noncontact seal. Impeller shaft displacement was measured using a laser sensor. Axial and radial displacements of the shaft were only a few micrometers for motor speed up to 8500 rpm. The shaft did not make contact with the bearing housing. A flow of 5 L/min was obtained at 8000 rpm at a pressure difference of 100 mm Hg. In conclusion, the axial flow blood pump consisting of a hydrodynamic bearing, a magnetic fluid seal, and a brushless DC motor provided contact-free rotation of the impeller without material wear.

In this study, we have developed an artificial esophagus simulating peristaltic movement with the use of a nickel-titanium shape memory alloy (NiTi-SMA) actuator. Serial pairs of NiTi-SMAs were placed around a Gore-Tex vascular graft in a helical position such that they obliterated the lumen of the vessel when they contracted. In an animal experiment using a goat, the cervical esophagus was resected over a length of approximately 20 cm. The artificial esophagus was anastomosed with the remaining cervical esophagus. When a direct current of 500 mA at 5 V was applied to the NiTi-SMAs, the first pair of the NiTi-SMA contracted. The following pairs of the NiTi-SMAs contracted consecutively. The entire contraction of the artificial esophagus was similar to the esophageal peristaltic movement observed by x-ray examination in humans. The results showed the possibility that the artificial esophagus could function as an artificial esophagus having peristaltic movement.

A rotating impeller in a rotary blood pump requires a supporting system in blood, such as a pivot bearing or magnetic suspension. To solve potential problems such as abrasive wear and complexity of a supporting system, a magnetic fluid seal was developed for use in an axial-flow blood pump. Sealing pressures at motor speeds of up to 8,000 rpm were measured with the seal immersed in water or bovine blood. The sealing pressure was about 200 mm Hg in water and blood. The calculated theoretical sealing pressure was about 230 mm Hg. The seal remained perfect for 743 days in a static condition and for 180+ days (ongoing test) at a motor speed of 7,000 rpm. Results of measurement of cell growth activity indicated that the magnetic fluid has no negative cytological effects. The specially designed magnetic fluid shaft seal is useful for an axial-flow blood pump.

In the development of a rotary blood pump, one of the major problems is thrombus formation near the shaft seal. To solve this problem, a magnetic fluid seal was developed for use in an axial flow pump. A magnetic fluid seal has several advantages, including a high degree of airtightness, no wear or noise, no heat generation, and a simple structure. To determine the reliability of the seal, the sealing pressure, durability, and amount of magnetic fluid mixed with liquids were examined. The seal was composed of two ferromagnetic polepieces and a Nd−Fe−B magnet. The magnetic fluid (LS-40) was injected into the gap between the motor shaft and the polepieces. To minimize leakage of the magnetic fluid, a shield was provided on the polepiece on the liquid side. Sealing pressures at motor speeds up to 10 000 rpm were measured with the seal immersed in water or bovine blood. The sealing pressures were 195 mmHg in water and 173 mmHg in blood. The results of magnetic FEM showed that the theoretical sealing pressure was about 230 mmHg for motor speeds up to 10 000 rpm. This result was almost the same as the measured pressure in was 691+ days (ongoing) at 8000 rpm and 51 days, and 47+ days (ongoing) in a rotating condition. There was only a small amount of magnetic fluid mixed with the liquid. The especially designed magnetic fluid shaft seal is considered to be useful for an axial flow pump.

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.

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.

Recently, zinc-releasing bioceramics have been the focus of much attention owing to their bone-forming ability. Thus, some types of zinc-containing calcium phosphate (e.g., zinc-doped tricalcium phosphate and zinc-substituted hydroxyapatite) are examined and their osteoblastic cell responses determined. In this investigation, we studied the effects of zinc calcium phosphate (ZCP) derived from zinc phosphate incorporated into calcium phosphate cement (CPC) in terms of its setting reaction and MC3T3-E1 osteoblast-like cell responses. Compositional analysis by powder X-ray diffraction analysis revealed that HAP crystals were precipitated in the CPC containing 10 or 30 wt% ZCP after successfully hardening. However, the crystal growth observed by scanning electron microscopy was delayed in the presence of additional ZCP. These findings indicate that the additional zinc inhibits crystal growth and the conversion of CPC to the HAP crystals. The proliferation of the cells and alkaline phosphatase (ALP) activity were enhanced when 10 wt% ZCP was added to CPC. Taken together, ZCP added CPC at an appropriate fraction has a potent promotional effect on bone substitute biomaterials.

A magnetic fluid seal enables mechanical contact-free rotation of a shaft without frictional heat and material wear and hence has excellent durability. However, the durability of a magnetic fluid seal decreases in liquid. The life of a seal applied to a rotary blood pump is not known. We have developed a magnetic fluid seal that has a shield mechanism minimizing the influence of the rotary pump on the magnetic fluid. The developed magnetic fluid seal worked for over 286 days in a continuous flow condition, for 24 days (on-going) in a pulsatile flow condition and for 24 h (electively terminated) in blood flow. The magnetic fluid seal is promising as a shaft seal for rotary blood pumps.

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 control of left ventricular assist device (LVAD) has been based on pressures of left ventricle (LV), aorta (AO) and pulmonary artery (PA) and flows in AO and PA. These parameters are one-dimensional and suitable for control of LVAD because they are numerical and quantitative. However, evaluation of the cardiac function by echocardiography is very useful in clinical settings because the cardiac function changes rapidly and dramatically. Transesophageal echocardiography is very useful for the assessment of cardiac function of the patients with LVAD implantation because it can detect and visualize what is happening in the heart immediately and directly.

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.

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 infomation 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 mea- sured 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. I. INTRODUCTION A rotary blood pump (RBP) is a device to keep blood circulation of a cardiac patient instead of his/her weakened native heart. Clinical studies with the RBP have been per- formed widely, and they have revealed that the assistance with the RBP unloads a native heart and promotes its recovery. Nowadays, the RBP 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)(1)(2). 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 addition, this information will be also helpful to realize the adaptive control algorithm for the RBP.

Pulse wave velocity (PWV) is the velocity of a pulse wave traveling a given distance between 2 sites in the arterial system, and is a well-known indicator of arteriosclerosis. Brachial-ankle PWV (baPWV) is a parameter more simple to obtain, compared with the conventional PWV, and is an easy and effective means of evaluating arteriosclerosis. BaPWV can be obtained by only wrapping the four extremities with blood pressure cuffs, and it can be easily used to screen a large number of subjects. Type A behavior has been confirmed as an independent risk factor for the development of coronary heart disease. To examine the relationship between Type A behavior and arteriosclerosis, 307 normal Japanese subjects were classified into either a Type A group (n = 90) or a non-Type A group (n = 217) by using Maeda's Type A Scale. BaPWV was evaluated using a PWV diagnosis device. The baPWV in the Type A group was significantly higher than that obtained in the non-Type A group. The baPWV showed a positive correlation with age both in the Type A group and in the non-Type A group; however, the straight-line regression slope of baPWV versus age in the Type A group was significantly larger than that in the non-Type A group. Therefore, our results suggest that arteriosclerosis might be promoted earlier in subjects expressing the Type A behavior pattern. Type A behavior pattern is confirmed as a risk factor for arteriosclerosis, and may increase the risk of the cardiovascular disease related to arteriosclerosis.

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.

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.

Pulse wave velocity (PWV) is a well-known indicator of arterial stiffness and a marker of the presence of vascular lesions. Cardiovascular mortality in Russia has become the highest in the world. The Japanese are enjoying long lives, and the mortality caused by cardiovascular diseases has thus far remained at lower levels than that in Russia. In this study, we focused on brachial-ankle pulse wave velocity (baPWV) obtained from normal human subjects in Russia as well as in Japan, and compared their respective cardiovascular risks. We evaluated baPWV in 337 Japanese and 138 Russian healthy subjects. The baPWV was recorded using a PWV diagnosis device. BaPWV was measured between 2 locations of the arterial tree. The baPWV in the Russian group was significantly higher than that obtained in the Japanese of two groups categorized by age (40-59 years and 60- years). Further, body mass index (BMI), systolic blood pressure (SBP) and diastolic blood pressure in the Russian group were significantly higher than those obtained in Japanese in three age groups (under 39 years, 40-59 years, and 60- years). Moreover, the baPWV indicated a positive correlation with age, BMI and SBP in both Japanese and Russians, although the increasing trend of the baPWV against age of the Russian group had a larger value than that of the Japanese. Therefore, we suggest that arterial stiffness might be promoted earlier in the Russian group, which might be the main cause of the increased cardiovascular risk in Russia.

A rotary blood pump (RP) is desirable as a small ventricular assist device (VAD). However, an RP is nonpulsatile. We tried to develop a device that attaches a pulse to the RP. We also tried to develop a pulse-generating equipment that was not air-pressure driven. The ball screw motor was considered a candidate. The application of a small-sized shape memory alloy was also attempted. An electrohydraulic system was adopted, and actuator power was connected to the diaphragm. The diaphragm was placed on the outer side of the ventricle. Most RPs that have been developed all over the world drain blood from the ventricle. The wave of a pulse should be generated if a pulse is added by the drawn part. The output assistance from the outer side of the ventricle was attempted in animal experiments, and the device operated effectively. This device can be used during implantable operation of RP. This may serve as an effective device in patients experiencing problems in peripheral circulation and in the function of internal organs.

The development of a rotary blood pump (RP) is desirable as it can be used as a small ventricular assistance device (VAD). However, a RP does not generate any pulse. It may be physiologically better for the patient if the RP could generate a pulse. We have attempted to develop a device that produces a pulse in the RP. Intra-aortic balloon pumping (IABP) is effective in producing a pulse. However, the IABP cannot be implanted inside the body. Therefore, an attempt was made to develop pulse-generating equipment that was not driven by air pressure. The ball screw motor was considered as a possible candidate. In the future, we plan to apply small shape memory alloys. An electrohydraulic system was adopted, and actuator power output was connected to the diaphragm. The diaphragm was placed outside the ventricle. Most RPs developed throughout the world drain blood from the ventricle. The pulse wave should be generated if a pulse is added by the part from which blood is being drawn. In this study, animal experiments were conducted and the output assistance was tested from outside the ventricle. The device operated effectively in the animal experiment. The RP can easily be equipped with this device at the time of performing the implant operation. For a patient with problems of peripheral circulation and the internal organ fiunction, it may prove to be an effective device.

Evaluation of hemolysis within a blood pump on a computer is useful for developing rotary blood pumps. The flow fields in the axial flow blood pump were analyzed using computational fluid dynamics (CFD). A blood damage index was calculated based on the changes in shear stress with time along 937 streamlines. Hemolysis of the pumps was measured using bovine blood. A good correlation between the computed and measured hemolysis results was observed. CFD analysis is useful for estimating hemolysis of rotary blood pumps on a computer.

A low rate of hemolysis is an important factor for the development of a rotary blood pump. It is, however, difficult to identify the areas where hemolysis occurs. Computational fluid dynamics (CFD) analysis enables the engineer to predict hemolysis on a computer. In this study, fluid dynamics throughout intracardiac axial flow pumps with different designs were analyzed three-dimensionally using CFD software. The computed pressure-flow characteristics of the pump were in good agreement with the measurements. The Reynolds shear stress was computed along particle trace lines. Hemolysis was estimated on the basis of shear stress (tau) and its exposure time (Deltat): dHb/Hb = 3.62 x 10(-7)(tau)(i)(2.416) x Delta(t)(i)(0.785). Particle damage increased with time along the particle trace lines. Hemolysis of each of the pumps was measured in vitro. The computed hemolysis values were in good agreement with the experimental results. CFD is a useful tool for developing a rotary blood pump.

One of the key technologic requirements for rotary blood pumps is the sealing of the motor shaft. A mechanical seal, a journal bearing, magnetic coupling, and magnetic suspension have been developed, but they have drawbacks such as wear, thrombus formation, and power consumption. A magnetic fluid seal was developed for an axial flow pump. A magnetic fluid seal is durable, simple, and non power consumptive. Long-term experiments and finite element modeling (FEM) analyses confirmed these advantages. The seal body was composed of a Ned-Fe magnet and two pole pieces; the seal was formed by injecting ferrofluid into the gap (50 microm) between the pole pieces and the motor shaft. To contain the ferrofluid in the seal and to minimize the possibility of ferrofluid making contact with blood, a shield with a small cavity was attached to the pole piece. While submerged in blood, the sealing pressure of the seal was measured and found to be 188 mm Hg with ferrofluid LS-40 (saturated magnetization, 24.3 kA/m) at a motor speed of 10,000 rpm and 225 mm Hg under static conditions. The magnetic fluid seals performed perfectly at a pressure of 100 mm Hg for 594 + days in a static condition, and 51, 39+, and 34+ days at a motor speed of 8,000 rpm. FEM analyses indicated a theoretical sealing pressure of 260 mm Hg. The state of the magnetic fluid in the seal in water was observed with a microscope. Neither splashing of magnetic fluid nor mixing of the magnetic fluid and water was observed. The specially designed magnetic fluid seal for keeping liquids out is useful for axial flow blood pumps. The magnetic fluid seal was incorporated into an intracardiac axial flow pump.