Feasibility of a miniature centrifugal rotary blood pump for low-flow circulation in children and infants

In this study, a seal-less, tiny centrifugal rotary blood pump was designed for low-flow circulatory support in children and infants. The design was targeted to yield a compact and priming volume of 5 ml with a flow rate of 0.5-4 l/min against a head pressure of 40-100 mm Hg. To meet the design requirements, the first prototype had an impeller diameter of 30 mm with six straight vanes. The impeller was supported with a needle-type hydrodynamic bearing and was driven with a six-pole radial magnetic driver. The external pump dimensions included a pump head height of 20 mm, diameter of 49 mm, and priming volume of 5 ml. The weight was 150 g, including the motor driver. In the mock circulatory loop, using fresh porcine blood, the pump yielded a flow of 0.5-4.0 l/min against a head pressure of 40-100 mm Hg at a rotational speed of 1800-4000 rpm using 1/4" inflow and outflow conduits. The maximum flow and head pressure of 5.25 l/min and 244 mm Hg, respectively, were obtained at a rotational speed of 4400 rpm. The maximum electrical-to-hydraulic efficiency occurred at a flow rate of 1.5-3.5 l/min and at a rotational speed of 2000-4400 rpm. The normalized index of hemolysis, which was evaluated using fresh porcine blood, was 0.0076 g/100 l with the impeller in the down-mode and a bearing clearance of 0.1 mm. Further refinement in the bearing and magnetic coupler are required to improve the hemolytic performance of the pump. The durability of the needle-type hydrodynamic bearing and antithrombotic performance of the pump will be performed before clinical applications. The tiny centrifugal blood pump meets the flow requirements necessary to support the circulation of pediatric patients.     

Development of a small implantable right ventricular assist device

The purpose of this program is to design, develop, and clinically evaluate a new, implantable right ventricular assist device (RVAD) that can be used as a component of an implantable biventricular assist device for patients with severe biventricular heart failure. The initial phase of this program resulted in a prototype RVAD, named DexAide, a modified version of the CorAide left ventricular assist device. In vitro testing was performed in a stand-alone circuit and in a true RVAD mode to evaluate pump performance. Pump flow and power were measured under various afterload and pump speed conditions. The pump performance requirements of 2 to 6 l/min and a pressure rise of 20 to 60 mm Hg were successfully met with pump speeds between 1,800 and 3,200 rpm. The nominal design point of 4 l/min and 40 mm Hg pressure rise was achieved at 2,450 +/- 70 rpm with a power consumption of 3.0 +/- 0.2 W. The initial in vitro testing met the design criteria for the new DexAide RVAD. Initial in vivo testing is under way, which will be followed by preclinical readiness testing and a pilot clinical trial in this 5-year program.     

HeartMate III: pump design for a centrifugal LVAD with a magnetically levitated rotor

A long-term, compact left ventricular assist device (LVAD), the HeartMate III, has been designed and fabricated, featuring a centrifugal pump with a magnetically levitated rotor. The pump has been optimized by in vitro testing to achieve a design point of 7 L/min against 135 mm Hg at high hydrodynamic efficiency (30%) and to be capable of up to 10 L/min under such a load. Furthermore, the pump has demonstrated no mechanical failures, low hemolysis (4-10 mg/dl plasma free Hb), and low thrombogenicity during six (40, 27, 59, 42, 27, and 49-day) in vivo bovine studies.     

A new design for a compact centrifugal blood pump with a magnetically levitated rotor

A compact centrifugal blood pump has been developed using a radial magnetic bearing with a two-degree of freedom active control. The proposed magnetic bearing exhibits high stiffness, even in passively controlled directions, and low power consumption because a permanent magnet, incorporated with the rotor, suspends its weight. The rotor is driven by a Lorentz force type of built-in motor, avoiding mechanical friction and material wear. The built-in motor is designed to generate only rotational torque, without radial and axial attractive forces on the rotor, leading to low power consumption by the magnetic bearing. The fabricated centrifugal pump measured 65 mm in diameter and 45 mm in height and weighed 0.36 kg. In the closed loop circuit filled with water, the pump provided a flow rate of 4.5 L/min at 2,400 rpm against a pressure head of 100 mm Hg. Total power consumption at that point was 18 W, including 2 W required for magnetic levitation, with a total efficiency of 5.7%. The experimental results showed that the design of the compact magnetic bearing was feasible and effective for use in a centrifugal blood pump.     

In vitro evaluation of the TandemHeart pediatric centrifugal pump

The pediatric TandemHeart pump is being developed for short-term circulatory support of patients varying in size from 2 to 40 kg. The pump withdraws blood from the left atrium via cannula inserted percutaneously, either through the right internal jugular vein or transhepatically, and pumps the blood back into the arterial system via the carotid or femoral artery. High resolution stereolithography (SLA) was used to create an upper housing and impeller design, which were assembled into a functional pump prototype. Pressure-flow characteristics of the pump were determined in a blood analogue solution and compared with the pressure-flow requirements of the intended cannulation. At 5,500 rpm, the pump was able to generate 0.4 L/min of flow with a pressure rise of 325 mm Hg and 2.0 L/min with a pressure rise of 250 mm Hg. The hydraulic performance of the pump will enable at least 50% of cardiac output when the arterial cannula is placed in the carotid artery. The hemolysis of the TandemHeart pediatric pump at 5,500 rpm was compared with the BP-50 pediatric centrifugal pump in vitro using bovine blood flowing at 0.4 L/min against 250 mm Hg. The TandemHeart pump produced a similar increase in plasma free hemoglobin levels during the duration of the 6 hour test.     

一种植入式磁悬浮离心血泵的体外流体力学实验研究

通过体外模拟循环实验台对一种植入式磁悬浮离心血泵进行体外流体力学实验。以新鲜羊血为循环介质,通过体外循环台测定在后负荷为100 mmHg,血泵在不同转速下的输出量;通过控制血泵的转速,测定在固定泵速下不同后负荷下的输出量。血泵测试工作电压为24 V,电流波动于0.3～0.75 A。血泵功率为7.2～18 W。在后负荷为100 mmHg下,泵速在2 900～3 900 rpm,输出流量为3～7.1 L/min。泵速为2500～3 500 rpm,血泵在后负荷69～163 mmHg下输出流量为1.02～5.87 L/min。在固定的转速下血泵的压力-流量呈负相关关系。体外实验血泵工作性能稳定,可以满足成人心室辅助的需求。血泵功率偏高仍需要进一步改进。     

Preload sensitivity of the Jarvik 2000 and HeartMate II left ventricular assist devices

The in vitro sensitivity of continuous flow pumps to preload and afterload pressure has been well characterized. We compared flow in the Jarvik 2000 and HeartMate II continuous flow left ventricular assist devices (LVADs) at different inflow and outflow pressures and different pump speeds. This allowed us to measure the impact of a changing inflow pressure on the pump flow rate at different speeds but against a constant afterload. The resulting preload sensitivity curves showed that, overall, both LVADs have a mean preload sensitivity of 0.07 L/min/mm Hg in the physiologic ranges of pressures and flows encountered during normal operation. The HeartMate II pump had an increased preload sensitivity (up to approximately 0.1 L/min/mm Hg) as the preload was increased. The preload sensitivity of the Jarvik 2000 LVAD was more variable, having several peaks and troughs as the preload was increased. In future LVADs, improved preload sensitivity may allow passive regulation of pump output, optimize ventricular unloading, and decrease the risk of ventricular suction by the pump.     

Magnetically suspended centrifugal blood pump with a self bearing motor

A magnetically suspended centrifugal blood pump with a self bearing motor has been developed for long-term ventricular assistance. A rotor of the self bearing motor is actively suspended and rotated by an electromagnetic field without mechanical bearings. Radial position of the rotor is controlled actively, and axial position of the rotor is passively stable within the thin rotor structure. An open impeller and a semiopened impeller were examined to determine the best impeller structure. The outer diameter and height of the impeller are 63 and 34 mm, respectively. Both the impellers indicated similar pump performance. Single volute and double volute structures were also tested to confirm the performance of the double volute. Power consumption for levitation and radial displacement of the impeller with a rotational speed of 1,500 rpm were 0.7 W and 0.04 mm in the double volute, while those in the single volute were 1.3 W and 0.07 mm, respectively. The stator of the self bearing motor was redesigned to avoid magnetic saturation and improve motor performance. Maximum flow rate and pressure head were 9 L/min and 250 mm Hg, respectively. The developed magnetically suspended centrifugal blood pump is a candidate for an implantable left ventricular assist device.     

Performance of a newly developed implantable centrifugal blood pump

The performance of the newly developed implantable centrifugal blood pump was investigated in vitro. The pump was developed with the end goal of building a versatile system that includes a left ventricular assist system with an internal secondary battery or an implantable biventricular assist system with two implantable blood pumps. The hydrodynamic characteristics and efficiency of the blood pump were evaluated, and the mechanical damage to the blood caused by the blood pump was assessed through a hemolysis test using fresh goat blood. The pump could generate 120 mm Hg at a flow rate of 5 L/min and a motor speed of 2,500 rpm. The electric input power to the pump was approximately 5 watts under these working conditions. The hemolysis caused by the pump was a bit higher than that by the former model, but stayed within an acceptable range. Performance of the pump in vitro was considered sufficient for a left ventricular assist device, although further design improvement is necessary in terms of hemolysis and system efficiency to improve biocompatibility of the pump.     

CFD analysis of a Mag-Lev ventricular assist device for infants and children: fourth generation design

Thousands of pediatric patients suffering from heart failure would benefit from longer-term mechanical circulatory support. There are, however, few support systems available in the United States as viable mechanical assist alternatives for these patients. Therefore, we have designed and developed an axial flow pediatric ventricular assist device (PVAD) with an impeller that is fully suspended by magnetic bearings. This blood pump is designed to generate 0.5-4 L/min for pressure rises of 50-95 mm Hg over 6,000-9,000 rpm. We have performed four major design iterations. Building upon the third design phase, we made improvements to create the PVAD4 model. Numerical simulations of the PVAD4 under steady flow simulations were performed to compare the predictions of the latest PVAD4 model to the earlier PVAD3 design. The PVAD4 design resulted in lower fluid stress levels and an increase in pressure generation. A blood damage analysis was also completed. As compared with the earlier PVAD3 design, the damage analysis of the PVAD4 indicated a reduction in the mean and maximum damage index for the new design. All of these numerical findings are encouraging and demonstrate progress toward achieving a superior pump design.     

Biventricular support with the Jarvik 2000 axial flow pump: a feasibility study

Patients with congestive heart failure who are supported with a left ventricular assist device (LVAD) may experience right ventricular dysfunction or failure that requires support with a right ventricular assist device (RVAD). To determine the feasibility of using a clinically available axial flow ventricular assist device as an RVAD, we implanted Jarvik 2000 pumps in the left ventricle and right atrium of two Corriente crossbred calves (approximately 100 kg each) by way of a left thoracotomy and then analyzed the hemodynamic effects in the mechanically fibrillated heart at various LVAD and RVAD speeds. Right atrial implantation of the device required no modification of either the device or the surgical technique used for left ventricular implantation. Satisfactory biventricular support was achieved during fibrillation as evidenced by an increase in mean aortic pressure from 34 mm Hg with the pumps off to 78 mm Hg with the pumps generating a flow rate of 4.8 L/min. These results indicate that the Jarvik 2000 pump, which can provide chronic circulatory support and can be powered by external batteries, is a feasible option for right ventricular support after LVAD implantation and is capable of completely supporting the circulation in patients with global heart failure.     

The helical flow pump with a hydrodynamic levitation impeller

The helical flow pump (HFP) is a novel rotary blood pump invented for developing a total artificial heart (TAH). The HFP with a hydrodynamic levitation impeller, which consists of a multi-vane impeller involving rotor magnets, stator coils at the core position, and double helical-volute pump housing, was developed. Between the stator and impeller, a hydrodynamic bearing is formed. Since the helical volutes are formed at both sides of the impeller, blood flows with a helical flow pattern inside the pump. The developed HFP showed maximum output of 19?l/min against 100?mmHg of pressure head and 11?% maximum efficiency. The profile of the H?CQ (pressure head vs. flow) curve was similar to that of the undulation pump. Hydrodynamic levitation of the impeller was possible with higher than 1,000?rpm rotation speed. The normalized index of the hemolysis ratio of the HFP to centrifugal pump (BPX-80) was from 2.61 to 8.07 depending on the design of the bearing. The HFP was implanted in two goats with a left ventricular bypass method. After surgery, hemolysis occurred in both goats. The hemolysis ceased on postoperative days?14 and 9, respectively. In the first experiment, no thrombus was found in the pump after 203?days of pumping. In the second experiment, a white thrombus was found in the pump after 23?days of pumping. While further research and development are necessary, we are expecting to develop an excellent TAH with the HFP.     

Mini hemoreliable axial flow LVAD with magnetic bearings: part 2: design description

This paper gives the preliminary configuration of the flow geometry used to eliminate bearing thrombus by forced pressure wash-out of the bearing gaps. This left ventricular assist device (LVAD) is physiologically controllable without extraneous sensors based on the measurement of pump differential pressure using the magnetic bearings. Knowing the LVAD differential pressure allows safe cyclic variation of impeller rpm with feedback around differential pressure, which obtains desired pressure pulsatility. Flow pulsatility is known to be of major benefit for minimizing thrombus in both the pump and arteries. It also results in improved perfusion of many organs. The ability of a conventional virtual zero power feedback loop to axially control the bearing in a long-term drift free manor is also explained.     

Magnetically suspended centrifugal blood pump with a radial magnetic driver

A new magnetic bearing has been designed to achieve a low electronic power requirement and high stiffness. The magnetic bearing consists of 1) radial passive forces between the permanent magnet ring mounted inside the impeller rotor and the electromagnet core materials in the pump casing and 2) radial active forces generated by the electromagnets using the two gap sensor signals. The magnetic bearing was assembled into a centrifugal rotary blood pump (CRBP) driven with a radial, magnetic coupled driver. The impeller vane shape was designed based upon the computational fluid dynamic simulation. The diameter and height of the CRBP were 75 mm and 50 mm, respectively. The magnetic bearing system required the power of 1.0-1.4 W. The radial impeller movement was controlled to within +/- 10 microm. High stiffness in the noncontrolled axes, Z, phi, and theta, was obtained by the passive magnetic forces. The pump flow of 5 L/min against 100 mm Hg head pressure was obtained at 1,800 rpm with the electrical to hydraulic efficiency being greater than 15%. The Normalized Index of Hemolysis (NIH) of the magnetic bearing CRBP was one fifth of the BioPump BP-80 and one half of the NIKKISO HPM-15 after 4 hours. The newly designed magnetic bearing with two degrees of freedom control in combination with optimized impeller vane was successful in achieving an excellent hemolytic performance in comparison with the clinical centrifugal blood pumps.     

A novel permanent maglev rotary LVAD with passive magnetic bearings

It has been widely acknowledged that permanent maglev cannot achieve stability; however, the authors have discovered that stable permanent maglev is possible under the effect of a combination of passive magnetic and nonmagnetic forces. In addition, a rotary left ventricular assist device (LVAD) with passive magnetic bearings has been developed. It is a radially driven impeller pump, having a rotor and a stator. The rotor consists of driven magnets and impeller; the motor coil and pump housing form the stator. Two passive magnetic bearings counteract the attractive force between motor coil iron core and rotor magnets; the rotor thereafter can be disaffiliated from the stator and become levitated under the action of passive magnetic and haemodynamic forces. Because of the pressure difference between the outlet and the inlet of the pump, there is a small flow passing through the gap of rotor and stator, and then entering the lower pressure area along the central hole of the rotor. This small flow comes to a full washout of all blood contacting surfaces in the motor. Moreover, a decreased Bernoulli force in the larger gap with faster flow produces a centring force that leads to stable levitation of the rotor. Resultantly, neither mechanical wear nor thrombosis will occur in the pump. The rotor position detection reveals that the precondition of levitation is a high rotating speed (over 3250 rpm) and a high flow rate (over 1 l min(-1)). Haemodynamic tests with porcine blood indicate that the device as a LVAD requires a rotating speed between 3500 and 4000 rpm for producing a blood flow of 4 - 6 l min(-1) against 100 mmHg mean pressure head. The egg-sized device has a weight of 200 g and an O.D. of 40 mm at its largest point.     

Development of "plug and play" TransApical to aorta VAD

Our TransApical to Aorta pump, a simple and minimally invasive left ventricular (LV) assist device, has a flexible, thin-wall conduit connected by six struts to a motor with ball bearings and a turbine extending into the blood path. Pulsatile flow is inherent in the design as the native heart contraction preloads the turbine. In six healthy sheep, the LV apex was exposed by a fifth intercostal left thoracotomy. The pump was inserted from the cardiac apex through the LV cavity into the ascending aorta. Aortic and LV pressure waveforms, pump flow, motor current, and pressure were directly measured. All six cannula pumps were smoothly advanced on the first attempt. Pump implantation was <15 minutes (13.6 +/- 1.8 minutes). Blood flow was 2.8 l/min to 4.4 l/min against 86 +/- 8.9 mm Hg mean arterial blood pressure at maximum flow. LV systemic pressure decreased significantly from 102.5 +/- 5.55 mm Hg to 58.8 +/- 15.5 mm Hg at the fourth hour of pumping (p = 0.042), and diastolic LV pressure decreased from 8.4 +/- 3.7 to 6.1 +/- 2.3 mm Hg (p > 0.05). The pump operated with a current of 0.4 to 0.7 amps and rotation speed of 28,000 to 33,000 rpm. Plasma free hemoglobin was 4 +/- 1.41 mg/dl (range, 2 to 5 mg/dl) at termination. No thrombosis was observed at necropsy.A left ventricular assist device using the transapical to aorta approach is quick, reliable, minimally invasive, and achieves significant LV unloading with minimal blood trauma.     

Hydrodynamic and static performance evaluation of the moving-actuator type biventricular assist device, AnyHeart

This study evaluated the hydrodynamic characteristics and efficiency of the moving-actuator type implantable biventricular assist device (BVAD), AnyHeart. A blood analog made of 52% glycerin and 48% water was used to simulate the density and viscosity of blood. The maximum pump flow was 9 L/min with 28.8 watts of power input, and the maximum electrical-to-hydraulic power conversion efficiency was approximately 11% at a pump flow of 3.5 L/min. The pump was able to generate 4 L/min output against 100 mm Hg afterload with less than 9 watts of power input. In addition to the overall system efficiency, the inner subpart power conversion efficiency was also evaluated. The system was subdivided according to system mechanism into three major parts: motor part, actuator part, and blood sac part. In normal working conditions (4 L/min, 100 mm Hg) with the AnyHeart, the total system efficiency was 8%, with subpart efficiencies of 50%, 85%, and 19% for motor part, actuator part, and blood sac part, respectively. The pump performance assessed in the in vitro Donovan-type mock circulation loop test was acceptable as a BVAD in terms of flow and pressure.     

World-first implantable aortic valvo-pump (IAVP) with sufficient haemodynamic capacity

For better anatomic and physiologic fitting, a novel implantable aortic valvo-pump (IAVP) has been developed. A valvo-pump is a micro axial flow impeller pump, which has the same dimensions and function, as well as the same location, of a valve. Therefore, IAVP needs no inlet and outlet tubes, no additional anatomic occupation, and has less physiologic disturbance to natural circulation compared with the traditional bypass left ventricular assist device (LVAD). The device has a stator and a rotor. The stator consists of a motor coil with an iron core and an outflow guide vane; the rotor includes driven magnets and impeller. There is neither bearing nor strut in both the pump and the motor. In order to reduce the attractive force between the rotor and the stator, so as to enhance the durability of the performance, the rotor magnets were minimized without reducing the driving torque and efficiency of the motor. The impeller vane was designed according to a three-dimensional and analytical method, for preventing stasis and turbulence. The largest outer diameter is 24.7 mm and the length at this point is 12.4 mm. The total weight is 40 g (including the rotor of 11 g). The consumed power is 7 W (14 V x 0.5 A) at 15 000 rpm. This rotating speed stays unchanged during haemodynamic testing together with a pulsatile centrifugal pump, which imitates a failing ventricle. The maximal flow cross IAVP reaches over 10 l min(-1) and the pressure head at 0 l min(-1) can be as large as 80 mmHg. At flow rate of 4 - 8 l min(-1), IAVP enlarges the flow c. 1 l min(-1) and meanwhile increases the pressure about 10 mmHg. The pressure pulsatility generated by the pulsatile centrifugal pump remains 40 mmHg after passing IAVP. By first animal experimental trial the device was sewed in aortic position of an 80 kg pig without harm to adjacent tissue and organs. IAVP promises to be a viable alternative to natural donor heart for heart transplantation in the future.     

Development of a novel shrouded impeller pediatric blood pump

The aim of this work was to analyze a shrouded impeller pediatric ventricular assist device (SIP-VAD). This device has distinctive design characteristics and parameter optimizations for minimization of recirculation flow and reduction in high-stress regions that cause blood damage. Computational Fluid Dynamics (CFD) simulations were performed to analyze the optimized design. The bench-top prototype of SIP-VAD was manufactured with biocompatible stainless steel. A study on the hydrodynamic and hemodynamic performance of the SIP-VAD was conducted with predictions from CFD and actual experimentation values, and these results were compared. The CFD analysis yielded a pressure range of 29–90 mmHg corresponding to flow rates of 0.5–3 L/min over 9000–11000 rpm. The predicted value of the normalized index of hemolysis (NIH) was 0.0048 g/100 L. The experimental results with the bench-top prototype showed a pressure rise of 30–105 mmHg for the flow speed of 8000–12000 rpm and flow rate of 0.5–3.5 L/min. The maximum difference between CFD and experimental results was 4 mmHg pressure. In addition, the blood test showed the average NIH level of 0.00674 g/100 L. The results show the feasibility of shrouded impeller design of axial-flow pump for manufacturing the prototype for further animal trials.     

Hemodynamic characteristics of a mixed flow pump prototype: progress report of in vitro and acute animal experiments

A new dual-inlet mixed-flow blood pump was designed and tested in our laboratory. The objective of the present study was to analyze hemodynamic characteristics of the pump prototype in vitro and during acute in vivo experiments. The mixed-flow pump was first tested in vitro and then implanted in 11 pigs and 3 calves. The left ventricular apex was cannulated with the pump and an outflow graft was anastomosed to the descending thoracic aorta. Flow and pressure probes were also implanted. Animals were killed 3 to 12 hours after surgery. In 11 pigs, pump outflow averaged 3.8 +/- 0.4, 4.5 +/- 0.4, 5.2 +/- 0.8, 5.9 +/- 0.3, and 6.5 l/min at 8,000, 9,000, 10,000, 11,000, and 12,000 pump speed in rpm. Differential pressure at the pump averaged 45 +/- 6, 54 +/- 8, 68 +/- 16, 70 +/- 12, and 85 +/- 7 mm Hg at 8,000, 9,000, 10,000, 11,000 and 12,000 rpm. Mean aortic pressure averaged 64 +/- 15 mm Hg throughout the procedures. In 3 calves, mean aortic pressure and left ventricular pressure remained stable during 4, 6, and 9 hours of support at 9,500, 10,000, 10,500, 11,000, and 11,500 rpm. The hemodynamic performance of our mixed-flow pump appears satisfactory during short-term support in animals. It supports similarly to axial-flow blood pumps in clinical trials. Based on these findings, an ameliorated design of this mixed-flow pump running at smaller rotational speed against a similar pressure head is under way.