Jian-Ye Zhou

Design optimization of an axial blood pump with computational fluid dynamics.

A fully implantable, axial flow blood pump has been developed in our hospital. Both in vitro and in vivo tests showed that the hemolysis and thrombus characteristics of the pump were in an acceptable but not in an ideal range. Computational fluid dynamics (CFD) and in vitro test results showed that the pump worked at off-design point with a low hydraulic efficiency; CFD analysis also showed regions of reverse flow in the diffuser, which not only decreases the pumps hydrodynamic efficiency, but also increases its overall potential for blood trauma and thrombosis. To make a blood pump atraumatic and nonthrombogenic, several methods were taken to reach a final model of the optimized blood pump using CFD, which decreased the rotational speed from 9,000 to 8,000 rpm, and the design flow rate from 11 to 6 L/min. More significantly, the flow separation and recirculation in the diffuser region were eliminated, which mitigated the traumatic and thrombus effect on blood. The acceptable results of the numerical simulations encourage additional in vitro and in vivo studies.

Off-Pump Pulmonary Valve Implantation of a Valved Stent With an Anchoring Mechanism

PURPOSE The purpose of this study was to evaluate the longitudinal performance and anti-migration effect of a bovine valved stent equipped with an anchoring mechanism implanted off-pump in the pulmonary position. DESCRIPTION Through a delivery system, the bell-shaped pulmonary valved stents were implanted off-pump in the pulmonary valve position into six sheep by the transventricular approach. Hemodynamic, angiographic, and echocardiographic evaluations were carried out before, immediately after, and 2 months after implantation. Macroscopic and radiographic examination were performed for evaluation. EVALUATION The valved stents were all successfully implanted off-pump in the pulmonary position on six sheep. Early and late angiographic, echocardiographic, hemodynamic, and macroscopic studies confirmed firm anchoring and good positions of the stents. All valved stents were potent, except one mild stenosis with a 24 mm Hg transvalvular pressure gradient that developed and one mild insufficiency that were discovered at the end of the study. CONCLUSIONS Transventricular implantation of the bell-shaped pulmonary valved stents was evaluated during a 2-month period in the sheep in the present study and showed a good structural and functional outcome with no migration.

in Vivo Experimental Testing of the Fw Axial Blood Pump for Left Ventricular Support in Fu Wai Hospital

A fully implantable, axial flow blood pump has been developed in Fu Wai Hospital aiming for clinical use. This ventricular assist device (VAD), which was developed after numerous CFD analyses for the flow characteristics of the pump, is 58.5-mm long, 30-mm wide (including DC motor), and weighs 240 g. The pump can deliver 5 L/min for pressures of 100 mm Hg over 8,000 rpm. In this study, short-term hemocompatibility effects of the axial left ventricular assist device (LVAD) (FW blood pump) were evaluated in four healthy sheep. The device was implanted into the left ventricular apex of beating hearts. The outflow graft of each device was anastomosed to the descending aorta. The hemolysis, which was evaluated in vivo by free hemoglobin value, was below 30 mg/dL. Evaluation of serum biochemical data showed that implantation of the FW blood pump in sheep with normal hearts did not impair end organ function. Gross and microscopic sections of kidney, liver, and lung revealed no evidence of microemboli. Performance of the pump in vivo was considered sufficient for a LVAD, although further design improvement is necessary in terms of hemolysis and antithrombosis to improve biocompatibility of the pump.

Numerical Simulation of LVAD Inflow Cannulas with Different Tip

The tip structure is one of the key factors to determine the performance of left ventricular assist device (LVAD) inflow cannulas. The tip structure influences the thrombosis, hemolysis in cannula and left ventricle and suction leading to obstruction in ventricle. We designed four kinds of inflow cannulas that had different tips and built the numerical models of the four historical used inflow cannulas inserted into the apex of left ventricle. We computed the hemodynamic characteristics of inflow cannulas insertion by Fluent software. We researched the backflow, turbulent flow and pressure distribution of the four inflow cannulas. The results showed that the trumpet tipped inflow cannula had smooth flow velocity distribution without backflow or low velocity flow. The trumpet tipped inflow cannula had the best blood compatibility characteristics. The trumpet structure could prevent obstruction. The caged tipped cannula had serious turbulent flow which could possibly cause thrombosis and the low pressure near left ventricle wall and easily lead to ventricle collapse. The trumpet tipped inflow cannula has the best blood compatibility and is difficult to be obstructed. The trumpet tipped inflow cannula is fit to long-term use LVAD.

Flow visualization in the outflow cannula of an axial blood pump.

The properties of blood flow in the outflow cannula of an axial blood pump play a critical role in potential thrombus formation and vascular injury. In this study, an in vitro flow visualization technique using particle image velocimetry (PIV) was applied to investigate the flow characteristics in the outflow cannula of a FW-2 model axial pump. The two-dimensional (2-D) flow field in the axial central section and the three-dimensional (3-D) flow field in the whole outflow cannula were examined with the PIV system. Tests were carried out with a blood-mimic working fluid in the axial pump at a rotational speed of 8500 ± 20 rpm with a flow rate of 5 L/min. The velocity distribution in the outflow cannula was analyzed to evaluate the flow characteristics. There was no backflow or stagnant flow in the tested area, while the flow velocity rapidly increased outside the boundary layer. A spiral flow was observed near the boundary layer, but this was worn off within the tested area. Based on the results, hemolysis and thrombus formation in the cannula, and injury to aortic endothelium are unlikely to occur due to spiral flow.

Numerical and In Vitro Experimental Investigation of the Hemolytic Performance at the Off-Design Point of an Axial Ventricular Assist Pump.

The ventricular assist pumps do not always function at the design point; instead, these pumps may operate at unfavorable off-design points. For example, the axial ventricular assist pump FW-2, in which the design point is 5 L/min flow rate against 100 mm Hg pressure increase at 8,000 rpm, sometimes works at off-design flow rates of 1 to 4 L/min. The hemolytic performance of the FW-2 at both the design point and at off-design points was estimated numerically and tested in vitro. Flow characteristics in the pump were numerically simulated and analyzed with special attention paid to the scalar sheer stress and exposure time. An in vitro hemolysis test was conducted to verify the numerical results. The simulation results showed that the scalar shear stress in the rotor region at the 1 L/min off-design point was 70% greater than at the 5 L/min design point. The hemolysis index at the 1 L/min off-design point was 3.6 times greater than at the 5 L/min design point. The in vitro results showed that the normalized index of hemolysis increased from 0.017 g/100 L at the 5 L/min design point to 0.162 g/100 L at the 1 L/min off-design point. The hemolysis comparison between the different blood pump flow rates will be helpful for future pump design point selection and will guide the usage of ventricular assist pumps. The hemolytic performance of the blood pump at the working point in the clinic should receive more focus.

Short-term in vivo preclinical biocompatibility evaluation of FW-II axial blood pump in a sheep model.

We investigated the outcome of FW-II axial pump on healthy sheep (weight, 60–70 kg) for 2 weeks by perioperatively hematological and chemical tests, and circulating activated platelet and leukocyte-platelet aggregates measurements by flow cytometry assays. Complete necropsy and histopathological examinations and thorough pump inspection were performed at study termination for evidence of thrombi. In this experimental series, one sheep died of pulmonary edema, the other four sheep reached the scheduled endpoint of 14 days without device-related problems, and flow range was maintained at 2.5–4.0 L/min. The number of red blood cells and platelets decreased within first 3 days but increased gradually after the first postoperative week. In all animals, serum glutamic oxaloacetic transaminase increased significantly after surgery but gradually returned to normal limits within 2 weeks. Platelet activation, granulocyte-platelet aggregates, and monocyte-platelet aggregates reached the peak at postoperative day 2. Postexplant examinations indicated round thrombus in the hub areas of pumps. No evidence of ischemia or infarction was found in the explanted hearts, livers, spleens, kidneys, and brains of the five animals. Our results demonstrate that FW-II ventricular assist device (VAD) is a promising device for left ventricular (LV) support with moderate anticoagulation.

Effects of Cone-Shaped Bend Inlet Cannulas of an Axial Blood Pump on Thrombus Formation: An Experiment and Simulation Study

Background Cannula shape and connection style influence the risk of thrombus formation in the blood pump by varying the blood flow characteristics inside the pump. Inlet cannulas should be designed based on the need for anatomical fit and reducing the risk of thrombus generation in the blood pump. The effects on thrombus formation of the cone-shaped bend inlet cannulas of axial blood pumps should be studied. Material/Methods The cannulas were designed as cone-shaped, with 1 bent section connecting 2 straight sections. Both the silicone tube and novel cone-shaped cannula were simulated for comparison. The flow fields of a blood pump with inlet cannula were simulated by computational fluid dynamics (CFD) at flows of 2.0, 2.5, and 3.0 liters per minute (lpm), with pump rotational speeds of 7500, 8000, and 8500 rpm, respectively. Then, 6 two-dimensional (2D) particle image velocimetry (PIV) tests were conducted and the velocity distributions were analyzed. Results A low-velocity region was located inside the pump entrance when a soft silicone tube was used. At 8500 rpm and 3.0 lpm working condition, the minimum velocity inside the pump with cone-shaped cannulas was 2.5×10−1 m/s. The cone-shaped cannulas eliminated the low-velocity region inside the pump. Both CFD and PIV results showed that the low-velocity region did not spread to the entrance of the blood pump within the flow range from 2.0 lpm to 7.0 lpm. Conclusions The designed cone-shaped bent cannulas can eliminate the low-velocity region inside the blood pump and reduce the risk of thrombus formation in the blood pump.

Design and numerical evaluation of an axial partial-assist blood pump for Chinese and other heart failure patients

A fully implantable axial left ventricular assist device LAP31 was developed for Chinese or other heart failure patients who need partial support. Based on the 5-Lpm total cardiac blood output of Chinese without heart failure disease, the design point of LAP31 was set to a flow rate of 3 Lpm with 100-mmHg pressure head. To achieve the required pressure head and good hemolytic performance, a structure that includes a spindly rotor hub and a diffuser with splitter and cantilevered main blades was developed. Computational fluid dynamics (CFD) was used to analyze the hydraulic and hemodynamic performance of LAP31. Then in vitro hydraulics experiments were conducted. The numerical simulation results show that LAP31 could generate a 1 to 8 Lpm flow rate with a 60.9 to 182.7 mmHg pressure head when the pump was rotating between 9,000 and 12,000 rpm. The average scalar shear stress of the blood pump was 21.7 Pa, and the average exposure time was 71.0 milliseconds. The mean hemolysis index of LAP31 obtained using Heusers hemolysis model and Giersiepens model was 0.220% and 3.89 × 105% respectively. After adding the splitter blades, the flow separation at the suction surface of the diffuser was reduced. The cantilever structure reduced the tangential velocity from 6.1 to 4.7–1.4 m/s within the blade gap by changing the blade gap from shroud to hub. Subsequently, the blood damage caused by shear stress was reduced. In conclusion, the hydraulic and hemolytic characteristics of the LAP31 are acceptable for partial support.

The miRNA Expression Profile in Acute Myocardial Infarct Using Sheep Model with Left Ventricular Assist Device Unloading

This study attempted to establish miRNA expression profiles in acute myocardial infarct (AMI) sheep model with left ventricular assist device (LVAD) unloading. AMI was established in sheep model and FW-II type axial flow pump was implanted to maintain continuous unloading for 3 days. The cardiomyocyte survival, inflammatory cell infiltration, and myocardial fibrosis were detected by tissue staining, and cardiomyocyte apoptosis was detected by TUNEL assay. High throughput sequencing technique was used to detect miRNA expression in cardiomyocytes and to establish miRNA expression profile. The Gene Ontology (GO) and Kyoto Encyclopedia of Genes and Genomes (KEGG) analyses were established. miRNA sequencing results identified 152 known mature miRNAs and 1582 new mature miRNAs. The unloading and control groups differentially expressed genes, of which RT-PCR verified oar-miR-19b and oar-miR-26a. The GO and KEGG pathway annotation and enrichment established that the regulating functions and signaling pathways of these miRNAs were closely related to cardiovascular diseases (CVD). In this study, LVAD effectively reduced the cell death degree of cardiomyocyte in MI. The established miRNA expression profiles of AMI and LVAD intervention in this study suggest that the expression profile could be used to explore the unknown miRNA and the regulatory mechanisms involved in AMI.