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Ventricular assist devices (VADs) which employ a maglev motor have significant advantages of high mechanical durability and better blood compatibility by eliminating mechanical contact for impeller suspension. In the last decade, research interest in maglev VADs for small pediatric patients is highly increased. However, drastic miniaturization of maglev motors has technical difficulties in deterioration of suspension stability and energy efficiency. Our group has developed an ultra-compact axial gap double stator self-bearing motor utilizing 5-degrees of freedom control for pediatric VADs to overcome the above technical drawbacks. In this article, feasibility of the proposed self-bearing concept for stable impeller suspension was verified, as well as enhancement of energy efficiency of the developed self-bearing motor was investigated by modifying motor core material and winding design. In pump operation with the modified motor, noncontact impeller suspension with energy input of 3.2–5.2 W over a range of pediatric circulatory support (4000–5000 r/mim) was demonstrated.

Background Extracorporeal membrane oxygenation (ECMO) is being increasingly used for mechanical support of respiratory and cardio-circulatory failure. An excessive systemic inflammatory response is observed during sepsis and after cardiopulmonary bypass (CPB) with similar clinical features. We hypothesized that hyperoxia condition encourages the systemic inflammatory response and organ disorder during ECMO. To prove this hypothesis correct, we investigated the systemic inflammatory responses at normal and high levels of arterial oxygen pressure (PaO2) in the rat ECMO model. Methods Rats were randomly assigned to one of the following groups depending on the value of PaO2 during ECMO: A group (n=11, PaO2 100-199 mmHg), B group (n=10, PaO2 200-299 mmHg), C group (n=8, PaO2 300-399 mmHg), and D group (n=11, PaO2 >400 mmHg). Serum cytokine levels [tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), and interleukin-10 (IL-10)] were measured before, 60, and 120 min after the initiation of ECMO. The wet-to-dry weight (W/D) ratio of the left lung was also measured, and dihydroethidium (DHE) staining, reflecting superoxide generation, of lung and liver tissues was performed 120 min after ECMO initiation. Results In the C and D groups, the pro-inflammatory cytokines (TNF-α and IL-6) significantly increased during ECMO compared with the other groups. On the other hand, the increase in anti-inflammatory cytokines (IL-10) was more suppressed in the C and D groups than in the other groups. The W/D ratio increased significantly more in the C and D groups than in the other groups. In addition, DHE fluorescence had a tendency to increase as the PaO2 rose. Conclusions These data demonstrate that it is better to avoid administration of too much oxygen during ECMO to attenuate lung injury linked to generation of superoxide and the systemic inflammatory response.

The purpose of this study was to observe and clarify the interventricular dysscynchrony caused by continuous-flow left ventricular assist device (CF-LVAD) support using the conductance method. During CF-LVAD support, the systolic phase of the left ventricle (LV) becomes shorter than that of the right ventricle (RV). Accordingly, timing of the systole and diastole during the cardiac cycle is not synchronous between the LV and RV. In this study, we evaluated this phenomenon in a normal heart model using the adult goat (n = 5, body weight 44.5 ± 2.9 kg). A centrifugal LVAD was implanted under general anesthesia. We inserted the conductance catheter into the RV and LV to obtain the pressure–volume relationship of the two ventricles simultaneously. We defined the dyssynchronous status as the sign (plus or minus) of the LV volume-change opposite to that of RV volume-change. Dyssynchronous phase of the cardiac cycle was observed in 5.6 ± 0.65% of hearts under LVAD pump-off and 25.3 ± 3.3% under LVAD full bypass, respectively (p

Under continuous-flow left ventricular assist device (CF-LVAD) support, the ventricular volume change and cardiac cycle between the left ventricle (LV) and right ventricle (RV) become dyssynchronous due to the shortening of the LV systole. The purpose of this study was to quantify interventricular dyssynchrony based on different CF-LVAD support conditions and assess its relationship with LV unloading. In this study, we evaluated seven goats (body weight 44.5 ± 6.5 kg) with normal hearts. A centrifugal LVAD was implanted under general anesthesia. We inserted the conductance catheters into the left ventricle (LV) and right ventricle (RV) to assess the volume signal simultaneously. We defined the interventricular dyssynchrony as a signal (increase or decrease) of LV volume (LVV) change opposite to that of RV volume (RVV) (i.e., (dLVV/dt) × (dRVV/dt)

An extracorporeal ventricular assist device (VAD) intended for patients with severe heart failure has been developed. The VAD consists of a centrifugal blood pump with a new hydrodynamic bearing system that enables non-contacting rotation of the impeller. Preclinical evaluation of the VAD system was performed by bench tests as well as by a series of chronic animal experiments. The bench tests demonstrated that the impeller successfully rotates without mechanical contact under a wide range of operating conditions. In the 30-day animal experiments, the VAD demonstrated good antithrombogenicity under LVAD conditions as well as RVAD conditions. The system was finally decided to have good biocompatibility for use within 30 days.

Although the influence of continuous-flow left ventricular assist device (CF-LVAD) support on peripheral circulation has been widely discussed, its monitoring modalities are limited. The aim of this study was to assess the peripheral circulation using the laser speckle flowgraph (LSFG) which can quantitatively measure the ocular blood flow. We implanted a centrifugal CF-LVAD (EVAHEART®; Sun Medical Technology Research Corporation, Nagano, Japan) in five adult goats (body weight 44.5 ± 2.9 kg) under general anesthesia. The waveform of the central retinal artery using the mean blur rate (MBR) for ocular blood velocity and fluctuations as a parameter of pulsatility were obtained before LVAD implantation and after LVAD full-bypass support. The MBR waveform and LSFG fluctuation data were compared with the waveform and pulsatility index of the external carotid artery using an ultrasonic flow meter to evaluate circulatory patterns at different levels. The MBR waveform pattern of the central retinal artery was pulsatile before LVAD implantation and less pulsatile under LVAD full bypass. The fluctuation was 14.7 ± 1.86 before LVAD implantation and 3.85 ± 0.61 under LVAD full bypass (p

Background Bridge-to-decision (BTD) devices providing temporary mechanical circulatory support should be introduced to patients with advanced heart failure. This study evaluated the effectiveness and safety of a BTD device comprising an innovative extracorporeal continuous-flow temporary ventricular assist device (VAD) driven by a novel hydrodynamically levitated centrifugal flow blood pump.Methods and Results:Nine patients, comprising 3 with dilated cardiomyopathy, 3 with fulminant myocarditis, and 3 with ischemic heart disease, and 6 males, whose mean age was 47.7±8.1 years, were enrolled into the study. Six patients had Interagency Registry for Mechanically Assisted Circulatory Support profile 1, and 3 were profile 2. The primary endpoint was a composite of survival free from device-related serious adverse events and complications during circulatory support. Eight patients received left ventricular support, of whom 3 received concomitant right ventricular support using extracorporeal membrane oxygenation circuits, as a consequence of severe respiratory failure. One patient with fulminant myocarditis received biventricular support using the novel VAD system. After 19.0±13.5 days, 3 patients were weaned from circulatory support, because their native cardiac function recovered, and 6 patients required conversion to a durable device as a bridge-to-transplantation. One patient had non-disabling ischemic stroke episodes, and no patients died. Conclusions This novel extracorporeal VAD system with a hydrodynamically levitated centrifugal pump can safely and successfully bridge patients with advanced heart failure to subsequent therapeutic stages.

We have studied the cardiac beat synchronization (CBS) control for a rotary blood pump (RBP) and revealed that it can promote pulsatility and reduce cardiac load. Besides, patients with LVAD support sometimes suffer from aortic and mitral regurgitation (AR and MR). A control method for the RBP should be validated in wider range of conditions to clarify its benefits and pitfalls prior to clinical application. In this study, we evaluated pulsatility and cardiac load reduction obtained with the CBS control on valvular failure conditions with a mathematical model. Diastolic assist could reduce cardiac load on the left ventricle by decreasing external work of the ventricle even in MR cases while it was not so effective in AR cases. Systolic assist can still promote pulsatility in AR and MR cases; however, aortic valve function should be carefully confirmed since pulse pressure can be wider not due to systolic assist but to AR.

BACKGROUND: Extracorporeal membrane oxygenation (ECMO) is being increasingly used for mechanical support of respiratory and cardio-circulatory failure. An excessive systemic inflammatory response is observed during sepsis and after cardiopulmonary bypass (CPB) with similar clinical features. We hypothesized that hyperoxia condition encourages the systemic inflammatory response and organ disorder during ECMO. To prove this hypothesis correct, we investigated the systemic inflammatory responses at normal and high levels of arterial oxygen pressure (PaO(2)) in the rat ECMO model. METHODS: Rats were randomly assigned to one of the following groups depending on the value of PaO(2) during ECMO: A group (n=11, PaO(2) 100–199 mmHg), B group (n=10, PaO(2) 200–299 mmHg), C group (n=8, PaO(2) 300–399 mmHg), and D group (n=11, PaO(2) >400 mmHg). Serum cytokine levels [tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), and interleukin-10 (IL-10)] were measured before, 60, and 120 min after the initiation of ECMO. The wet-to-dry weight (W/D) ratio of the left lung was also measured, and dihydroethidium (DHE) staining, reflecting superoxide generation, of lung and liver tissues was performed 120 min after ECMO initiation. RESULTS: In the C and D groups, the pro-inflammatory cytokines (TNF-α and IL-6) significantly increased during ECMO compared with the other groups. On the other hand, the increase in anti-inflammatory cytokines (IL-10) was more suppressed in the C and D groups than in the other groups. The W/D ratio increased significantly more in the C and D groups than in the other groups. In addition, DHE fluorescence had a tendency to increase as the PaO(2) rose. CONCLUSIONS: These data demonstrate that it is better to avoid administration of too much oxygen during ECMO to attenuate lung injury linked to generation of superoxide and the systemic inflammatory response.

Although the innovation has come in ECMO field, many problems remain unresolved. One of the main problems is about long-term durability and biocompatibility. Another is the system’s size, weight, and its complicated equipment. For the former problem, we have previously developed ECMO system which consists of a tiny, hydrodynamically levitated centrifugal pump (BIOFLOAT-NCVC), a membrane oxygenator with hollow polyolefin fibers (BIOCUBE-NCVC), and the circuit treated with a heparin-bonding material (T-NCVC coating), and reported three cases of animal experiments for 30-day heparin-free drive. For the latter problem, we have integrated these elements to the compact system with sensors of temperature, pressure, and SvO2, and blood flow. Its installation area is 595 cm2, weighs 8.9 kg with attachable oxygen cassette, and battery which could last an hour at least. To evaluate the biocompatibility of this system, this ECMO was installed in four goats. Scheduled duration was 14 days. Heparin was continuously infused to control their ACT between 150 and 200 s except one 2-week experiment without systemic heparinization. All of the four goats survived till the scheduled termination. Function of the pump and the oxygenator during ECMO was stable. No obvious adverse events were observed. All lab data were of normal range after 1 week. Small infarctions were found at kidneys, but they were not clinically significant. No thrombus was found in the pump system. The oxygenators were extremely clean except a little thrombus formation; while, the heparin-free examination revealed acceptable cleanliness. The present study revealed good anti-thrombogenicity of this ultra-compact durable ECMO system with heparinization. Our system encourages awake and extubated management, rehabilitation, inter-hospital transfer, and prehospital initiation of ECMO.

Aortic insufficiency (AI) is a crucial complication during continuous-flow left ventricular assist device (LVAD) support. Our previous clinical study suggested that a larger angle between the outflow graft and the aorta (O–A angle) could cause AI progression. This study examined the effect of the O–A angle on the hemodynamics of AI under LVAD support in an acute animal experimental model. An LVAD was installed in seven calves, with the inflow cannula inserted from the LV apex and with the outflow graft sutured at the ascending aorta. The AI model was made using a temporary inferior vena cava filter inserted from the LV apex and placed at the aortic valve. Cardiac dysfunction was induced by continuous beta-blocker infusion. Hemodynamic values and the myocardial oxygen extraction rate (O2ER) were evaluated at three O–A angles (45°, 90°, and 135°) over three levels of AI (none, Sellers I–II AI, and Sellers III–IV AI). The recirculation rate, defined as the percentage of regurgitation flow to LVAD output, was calculated. Systemic flow tended to decrease with a larger O–A angle. The recirculation rate was significantly increased with a larger O–A angle (22, 23, and 31% at 45°, 90°, and 135° in Sellers III–IV AI, respectively). Coronary artery flow was decreased at a larger O–A angle (86, 76 and 75 mL/min at 45°, 90°, and 135° in Sellers I–II AI, respectively, and 77, 67, and 56 mL/min at 45°, 90°, and 135° in Sellers III–IV AI, respectively). O2ER tended to increase with a larger O–A angle (40, 43, and 49% at 45°, 90°, and 135° in Sellers III–IV AI, respectively). A larger O–A angle can increase the recirculation due to AI and can be disadvantageous to LVAD-AI hemodynamics and myocardial oxygen metabolism.

We evaluated the usefulness of xeno-Biosheets, an in-body tissue architecture-induced bovine collagenous sheet, as repair materials for abdominal wall defects in a beagle model. Biosheets were prepared by embedding cylindrical molds into subcutaneous pouches of three Holstein cows for 2–3 months and stored in 70% ethanol. The Biosheets were 0.5 mm thick, cut into 2 cm × 2 cm, and implanted to replace defects of the same size in the abdominal wall of nine beagles. The abdominal wall and Biosheets were harvested and subjected to histological evaluation at 1, 3, and 5 months after implantation (n = 3 each). The Biosheet and bovine pericardiac patch (control) were not stressed during the suture operation and did not split, and patches were easily implanted on defective wounds. After implantation, the patch did not fall off and was not perforated, and healing was observed nacroscopically in all cases. During the first month of implantation, accumulation of inflammatory cells was observed along with decomposition around the Biosheet. Decomposition was almost complete after 3 months, and the Biosheet was replaced by autologous collagenous connective tissue without rejection. After 5 months, the abdominal wall muscle elongated from the periphery of the newly formed collagen layer and the peritoneum was formed on the peritoneal cavity surface. Regeneration of almost all layers of the abdominal wall was observed. However, almost all pericardium patches were remained even at 5 months with inflammation. Bovine Biosheets requiring no special post-treatment can be useful as off-the-shelf materials for abdominal wall repair.

A type-C mold based on in-body tissue architecture was previously developed for preparing small-diameter biotube vascular grafts with a 2-mm diameter and approximately 1-mm wall thickness. In this study, the type-C mold was modified for preparing large-diameter biotubes with controlled wall thicknesses. Four types of molds were assembled by inserting silicone center rods (outer diameters 11, 13, 15, 17 mm) into stainless steel cages (inner diameter 19 mm) and surgically embedded in the abdominal subcutaneous pouches of Holstein cows. After 8-12 weeks, connective tissues occupied the rod-cage gap in the molds to form biotubes. The wall thickness of the biotubes obtained after removing the molds was approximately 1-3 mm, which corresponded to approximately 80% of each gap distance. The breaking strength almost linearly increased with the wall thickness of the biotubes. The strength of the biotubes with wall thickness over 1.5 mm was higher than that of beagle blood vessels. The thickest biotubes were as strong as bovine pericardium and can be used as an alternative trachea graft because of their adequate lumen-holding force.

In the development of a new device for extracorporeal circulation, long-term durability and biocompatibility are required. The CAPIOX SL Pump (SL pump, Terumo Corporation, Tokyo, Japan), which is a centrifugal pump using a two-pivot bearing, was developed with the hope of suppressing pump thrombus formation around the bearings. This study aimed to evaluate the in vivo performance of the SL pump in the condition assumed severe clinical situation for long-term extracorporeal membrane oxygenation (ECMO) support. Extracorporeal circulation using the SL pump was installed in three goats, with drainage from the inferior vena cava and infusion into the right jugular artery. The animals were maintained with target pump flow of 2.0-3.0 L/min for 3 or 7 days. Anticoagulation was performed by continuous infusion of heparin with a target activated coagulation time (ACT) of 200 ± 50 s. Blood tests were performed regularly. After 3 or 7 days, autopsies were performed on all animals. The pumps were disassembled and observed for thrombus formation. The results were compared with those of our previous study of the current model of the centrifugal pump (SP pump). All animals were successfully managed within target pump flows and ACT values during the scheduled period, with no adverse events. No thrombus formation was found around the bearing of the SL pump. The blood tests showed normal major organ functions, and platelet consumption and hemolysis were significantly lower in this study compared to the previous study of the SP pump. The CAPIOX SL Pump showed excellent durability and biocompatibility in a large animal experiment.

Several species of domestic animals are used in preclinical studies evaluating the safety and feasibility of medical devices; however, the relevance of animal models to human health is often not clear. The purpose of this study was to compare the clotting parameters of animal models to determine which animals most adequately mimic human clotting parameters. The clotting parameters of the different species were assessed in whole blood by in vitro thromboelastography using the clotting activators, such as tissue factor (extrinsic clotting screening test, EXTEM®) and partial thromboplastin phospholipid (intrinsic clotting screening test, IINTEM®). The measurements were performed using normal blood samples from humans (n = 13), calves (n = 18), goats (n = 56) and pigs (n = 8). Extrinsic clotting time (CT) and the intrinsic CT were significantly prolonged in calves compared to humans (249.9 ± 91.3 and 376.4 ± 124.4 s vs. 63.5 ± 11.8 and 192.5 ± 29.0 s, respectively, p

Purpose An extracorporeal centrifugal-flow left ventricular assist device (CF-E-LVAD) system (BR16010) was newly developed. Since implantation of the durable implantable LVAD (I-LVAD) is still controversial in patients with cardiogenic shock or refractory heart failure because of its significant inferiority of outcomes as compared with higher INTERMACS profile patients, short-term E-LVADs have been still clinically important for bridging strategy for the next definitive treatment. Our aim of this study was to evaluate the influence of the novel developed CF-E-LVAD on the clinical prognosis in patients with bridging strategy, as compared with conventional extracorporeal pulsatile flow LVAD (PF-E-LVAD). Methods We retrospectively reviewed the medical records of 62 patients who were implanted E-LVAD as bridging strategy from April 2011 to January 2019. Six patients (9.7%) were implanted CF-E-LVAD. The clinical prognosis until 30 days after E-LVAD implantation, and the change of cardiac function and laboratory data at the early follow up were evaluated. Results Improvement of left ventricular ejection fraction was significantly greater in the CF-E-LVAD group than in the PF-E-LVAD group (217.9 [147.8 to 335.3] vs 38.3 [-21.7 to 128.8] %, P=0.010). Serum total bilirubin level significantly improved in CF-E-LVAD group than in the PF-E-LVAD group (-7.9 [-33.3 to 82.4] vs 68.8 [10.0 to 202.1] %, P=0.041). Although clinical courses, including death, cerebrovascular accidents and re-thoracotomy due to removal of mediastinal hematoma, were no significant difference between two groups, almost half (54.5%) in the PF-E-LVAD group was still ongoing the E-LVAD support at the 30 days post-E-LVAD implantation while only one patient (16.7%) was supported with E-LVAD in the CF-E-LVAD group. Conclusion The novel developed CF-E-LVAD system might influence on the earlier recovery of cardiac function and the multiple organ failure, and lead to the earlier decision for next definitive strategy.

Objectives Continuous-flow left ventricular assist devices (CF-LVADs) are widely used to treat patients with end-stage heart failure. Although continuous flow is different from physiological flow, patients show improved outcomes after CF-LVAD implantation. A novel rotational speed (RS) modulation system used with CF-LVAD (EVAHEART) has been developed, which can change RS in synchronization with the native cardiac cycle. We conducted the present study to investigate the influence of the system on pulsatility in peripheral perfusion. Methods We implanted EVAHEART devices at the left ventricular apex drainage and the descending aortic perfusion via a left thoracotomy in 7 adult goats (56.8 ± 8.1 kg). Cardiogenic shock was induced by a beta-adrenergic antagonist. We evaluated the pulsatility index and maximal time derivative of flow rate (max dQ/dt) of the carotid, mesenteric and renal arteries. These data were collected with a bypass rate of 100% under 4 conditions: circuit clamp, continuous mode, co-pulse mode (increased RS during systole) and counter-pulse mode (increased RS during diastole). Results The pulsatility indexes of the carotid and renal artery in the co-pulse mode were significantly higher than in the other modes. Max dQ/dt of the carotid and mesenteric arteries were significantly higher in the co-pulse mode than in the counter-pulse mode. Conclusions The co-pulse mode of this novel RS modulation system may provide better pulsatility not only in the large vessels but also in the peripheral vasculature.

Aortic valve regurgitation (AR) is a serious complication under left ventricular assist device (LVAD) support. AR causes LVAD-left ventricular (LV) recirculation, which makes it difficult to continue LVAD support. However, the hemodynamics and myocardial oxygen metabolism of LVAD support with AR have not been clarified, especially, how pump rotation speed influences them. An animal model of LVAD with AR was newly developed, and how pump rotation speed influences hemodynamics and myocardial oxygen metabolism was examined in acute animal experiments. Five goats (55 ± 9.3 kg) underwent centrifugal type LVAD, EVAHEART implantation. The AR model was established by placing a vena cava filter in the aortic valve. Hemodynamic values and the myocardial oxygen consumption, delivery, and oxygen extraction ratio (O2ER) were evaluated with changing pump rotation speeds with or without AR (AR+, AR-). AR+ was defined as Sellers classification 3 or greater. AR was successfully induced in five goats. Diastolic aortic pressure was significantly lower in AR+ than AR- (p = 0.026). Central venous pressure, mean left atrial pressure, and diastolic left ventricular pressure were significantly higher in AR+ than AR- (p = 0.010, 0.047, and 0.0083, respectively). Although systemic flow did not improve with increasing pump rotation speed, LVAD pump flow increased over systemic flow in AR+, which meant increasing pump rotation speed increased LVAD-LV recirculation and did not contribute to effective systemic circulation. O2ER in AR- decreased with increasing pump rotation speed, but O2ER in AR+ was hard to decrease. The O2ER in AR+ correlated positively with the flow rate of LVAD-LV recirculation (p = 0.012). AR caused LVAD-LV recirculation that interfered with the cardiac assistance of LVAD support and made it ineffective to manage with high pump rotation speed.

Introduction: The first choice of vascular access for hemodialysis is an autogenous arteriovenous fistula, because prosthetic arteriovenous grafts have a high probability of failure. In this study, Biotubes, in-body tissue architecture–induced autologous collagenous tubes, were evaluated for their potential use as vascular access grafts. Three animal implantation models were developed using beagle dogs, and the in vivo performance of Biotubes was observed after implantation in the acute phase as a pilot study. Methods: Biotubes (internal diameter ca. 4.0 mm, length ca. 5.0 cm, and wall thickness ca. 0.7 mm) were prepared through subcutaneous embedding of specially designed molds in beagle dogs for 8 weeks. The Biotubes were then implanted between the common carotid artery and the jugular vein of beagles via three methods, including side-to-side (in) -end-to-end (out) as type 1 (n = 4), side-to-side (both) as type 2 (n = 4), and side-to-end (in) -end-to-side (out) as type 3 (n = 1 using a composite Biotube). Results: Although two cases in type 1 and 2 resulted in Biotube deformation, all cases were patent for 4 weeks and maintained a continuous turbulent flow. At 4 weeks after implantation, percutaneous puncture could be performed repeatedly without aneurysm formation or hemorrhage. Conclusion: Within a short implantation period, with limited animal numbers, this proof-of-concept study showed that Biotubes may have a high potential for use in vascular access.

Background Tissues formed by in-body tissue architecture (iBTA) are soft and flexible. However, strongly bending iBTA-induced vascular grafts, called biotubes, may cause lumen collapse by kinking, subsequently leading to occlusion after implantation. In this study, we developed a method for biotube shape memory and verified its performance in preliminary animal implantation experiments. Methods Straight biotubes were prepared by subcutaneous embedding of straight molds into beagle dogs for two months. Upon overnight immersion of the obtained straight biotubes in a 70% ethanol solution under U-shape framing, the biotubes maintained their U shape even after washing with saline solution. Additionally, spiral-shaped biotubes formed from goats using spiral molds could be stretched straight via the same alcohol treatment. Results Within limited acute-phase animal implantation experiments, U-shaped biotubes functioned as AV shunt grafts in the femoral region of the beagle without deformation of vascular shape (N.=11). In addition, the long straight biotubes derived from spiral molds could be interposed between goat carotid arteries while maintaining their straight shape (N.=2). All implants maintained perfect patency at the 1-month follow-up period without any evidence of vascular deformation. Conclusions By retaining iBTA-induced tissues in an alcohol solution in the target shape, the shape of the tissues was imprinted and maintained even after implantation within a limited acute period. Therefore, in order to obtain tissues of various shapes, it is unnecessary to use a mold design to maintain the individual shape.

Research interests of compact magnetically levitated motors have been strongly increased in development of durable and biocompatible mechanical circulatory support (MCS) devices for pediatric heart disease patients. In this study, an ultra-compact axial gap type self-bearing motor with 5-degrees of freedom (DOF) active control for use in pediatric MCS devices has been developed. The motor consists of two identical motor stators and a centrifugal levitated rotor. This paper investigated a design improvement of the magnetic circuit for the self-bearing motor undergoing development in order to diminish energy input by enhancing magnetic suspension and rotation performances. Geometries of the motor were refined based on numerical calculation and three-dimensional (3D) magnetic field analysis. The modified motor can achieve higher suspension force and torque characteristics than that of a previously developed prototype motor. Oscillation of the levitated rotor was significantly suppressed by 5-DOF control over rotating speeds up to 7000 rpm with lower energy input, indicating efficacy of the design refinement of the motor.

We studied a control method of rotary blood pumps (RBPs), which is called as the cardiac beat synchronization (CBS) system. Usually, RBPs operate at constant target rotational speed, meanwhile, the CBS system modulates target speed synchronizing with cardiac beat. We built a computer simulation method to evaluate the CBS system. This simulator acquires a mathematical model of a circulatory system including a RBP and can provide us the theoretical hemodynamics when our control method is applied. We compared theoretical results with experimental ones with the model focusing on both pulsatility and aortic valve (AV) opening interval enhanced by the CBS system. Our simulator could reproduce behavior of the circulatory system whether the RBP is connected or not. Comparison among no RBP, constant assist, systolic assist, and diastolic assist modes indicated that pulsatility is enhanced with systolic assist theoretically. While systolic assist decreased AV opening interval, diastolic assist made it longer than the ones in other control strategies.

We developed a novel miniaturized extracorporeal centrifugal pump "BIOFLOAT NCVC (Nipro Corporation Osaka, Japan) as a ventricular assist device (VAD) and performed a preclinical study that is part of the process for its approval as a bridge to decision by the pharmaceutical and medical device agencies. The aim of this study was to assess the postoperative performance, hemocompatibility, and anticoagulative status during an extended period of its use. A VAD system, consisting of a hydrodynamically levitated pump, measuring 64 mm by 131 mm in size and weighing 635 g, was used. We installed this assist system in 9 adult calves (body weight, 90 ± 13 kg): as left ventricular assist device (LVAD) in 6 calves and right ventricular assist device (RVAD) in 3 calves, for over 30 days. Perioperative hemodynamic, hematologic, and blood chemistry measurements were obtained and end-organ effects on necropsy were investigated. All calves survived for over 30 days, with a good general condition. The blood pump was operated at a mean rotational speed and a mean pump flow of 3482 ± 192 rpm and 4.08 ± 0.15 L/min, respectively, for the LVAD and 3902 ± 210 rpm and 4.24 ± 0.3 L/min, respectively, for the RVAD. Major adverse events, including neurological or respiratory complications, bleeding events, and infection were not observed. This novel VAD enabled a long-term support with consistent and satisfactory hemodynamic performance and hemocompatibility in the calf model. The hemodynamic performance, hemocompatibility, and anticoagulative status of this VAD system were reviewed.