婴幼儿心室辅助泵——20mL罗叶泵体外测试平台的建立和性能研究

目的 设计并制作基于婴幼儿心室辅助泵——罗叶泵的体外测试平台,分别完成20 mL婴幼儿罗叶泵的流体性能实验和耐疲劳实验。方法 将罗叶泵驱动装置、20 mL婴幼儿罗叶泵、前负荷腔、前负荷压力传感器、后负荷腔、前负荷压力传感器、心电监护器、阻尼器和流量计等按不同的实验目的组装成不同的测试平台,流体温度控制为37 ℃,分别用来完成20 mL婴幼儿罗叶泵的流体性能实验和耐疲劳实验。结果 所制作的流体性能实验平台能较好的模拟人体前后负荷;在固定泵输出压力时,测量了20 mL婴幼儿罗叶泵泵频率与泵前压力（前负荷）、泵后压力（后负荷）和流量的关系;所组装的耐疲劳实验平台能够测试罗叶泵的耐疲劳性能;20 mL婴幼儿罗叶泵在连续搏动70 d后,其形变率仅为4 %。结论 所组装的搏动泵测试平台能测试20 mL婴幼儿罗叶泵的流体性能和耐疲劳性能;所制作的20mL婴幼儿罗叶泵具有较好的稳定性和耐疲劳性。 更多还原     

In vitro hemodynamic evaluation of ventricular suction conditions of the EVAHEART ventricular assist pump

Purpose: Mismatches between pump output and venous return in a continuous-flow ventricular assist device may elicit episodes of ventricular suction. This research describes a series of in vitro experiments to characterize the operating conditions under which the EVAHEART centrifugal blood pump (Sun Medical Technology Research Corp., Nagano, Japan) can be operated with minimal concern regarding left ventricular (LV) suction. Methods: The pump was interposed into a pneumatically driven pulsatile mock circulatory system (MCS) in the ventricular apex to aorta configuration. Under varying conditions of preload, afterload, and systolic pressure, the speed of the pump was increased step-wise until suction was observed. Identification of suction was based on pump inlet pressure. Results: In the case of reduced LV systolic pressure, reduced preload (=10 mmHg), and afterload (=60 mmHg), suction was observed for speeds =2,200 rpm. However, suction did not occur at any speed (up to a maximum speed of 2,400 rpm) when preload was kept within 10-14 mmHg and afterload =80 mmHg. Although in vitro experiments cannot replace in vivo models, the results indicated that ventricular suction can be avoided if sufficient preload and afterload are maintained. Conclusion: Conditions of hypovolemia and/or hypotension may increase the risk of suction at the highest speeds, irrespective of the native ventricular systolic pressure. However, in vitro guidelines are not directly transferrable to the clinical situation; therefore, patient-specific evaluation is recommended, which can be aided by ultrasonography at various points in the course of support.     

Biventricular support using a centrifugal pump in a 6 year old with fulminant myocarditis

We experienced a case of ventricular assist with both a pulsatile-flow and a continuous-flow pump in a pediatric patient, and herein report the clinical course and characteristics of the pumps. A 6-year-old female was diagnosed with fulminant myocarditis and transferred to our hospital for mechanical support. After 12 days of extracorporeal membrane oxygenation, we implanted a left ventricular assist device (LVAD) and a right ventricular assist device (RVAD) using centrifugal Gyro pumps with a membrane oxygenator in a paracorporeal fashion. The membrane oxygenator was removed on postoperative day (POD) 4, and the patient was weaned from the respirator on POD 6. The LVAD was exchanged on POD 13 and 17, and the RVAD was exchanged on POD 14 because of thrombus formation inside the pumps. The RVAD was removed on POD 25. On POD 32, the patient experienced cerebral infarction and the centrifugal Gyro pump was switched to an extracorporeal pulsatile pump. No thromboembolic event occurred after pump conversion, although continuous administration of vasodilators was required to avoid hypertension. She underwent successfully heart transplantation in the USA after 8 months of ventricular support. A centrifugal pump is considered useful for pediatric patients, as pump flow and blood pressure can be relatively easily controlled in the postoperative acute phase compared with the pulsatile pump. However, special care should be taken to monitor for thrombus formation when support length becomes longer than 13 days, and a switch to a pulsatile pump should be considered once the hemodynamic status stabilizes.     

Left heart bypass support with the Rotaflow Centrifugal Pump? as a bridge to decision and recovery in an adult

Since left heart bypass or biventricular circulatory assist with an extracorporeal centrifugal pump as a bridge to decision or recovery sometimes requires long-time support, the long-term durability of extracorporeal centrifugal pumps is crucial. The Rotaflow Centrifugal Pump(?) (MAQUET Cardiopulmonary AG, Hirrlingen, Germany) is one of the centrifugal pumps available for long-term use in Japan. However, there have been few reports of left heart bypass or biventricular circulatory support over the mid-term. This is a case report of left heart bypass support with the Rotaflow Centrifugal Pump(?) as a bridge to decision and recovery for an adult patient who could not be weaned from cardiopulmonary bypass and percutaneous cardiopulmonary support after cardiac surgery. We could confirm that the patient's consciousness level was normal; however, the patient could not be weaned from the left heart bypass support lasting 1 month. Therefore, the circulatory assist device was switched to the extracorporeal Nipro ventricular assist device (VAD). This time, left heart bypass support could be maintained for 30 days using a single Rotaflow Centrifugal Pump(?). There were no signs of hemolysis during left heart bypass support. The Rotaflow Centrifugal Pump(?) itself may be used as a device for a bridge to decision or recovery before using a VAD in cardiogenic shock patients.     

Clinical use of the abiomed BVS 5000 as a pulsatile extracorporeal membrane oxygenation unit

The traditional extracorporeal membrane oxygenation circuit uses a centrifugal pump. These pumps require close monitoring and are subject to complications. In addition, they do not take advantage of the potential benefits of pulsatile flow. These extracorporeal membrane oxygenation circuits use a single pump with an inline oxygenator. If cardiac failure persists after respiratory recovery has occurred, removal of the oxygenator requires an additional procedure to convert the patient to biventricular support. This report describes a circuit in which an oxygenator is connected to a pulsatile ventricular assist device. Single and dual circuit configurations are illustrated. Recommendations for pulmonary care during support are also described.     

The effect of left ventricular function and drive pressures on the filling and ejection of a pulsatile pediatric ventricular assist device in an acute animal model

Penn State is currently developing a 12-mL, pulsatile, pneumatically driven pediatric ventricular assist device intended to be used in infants. After extensive in vitro testing of the pump in a passive-filling, mock circulatory loop, an acute animal study was performed to obtain data with a contracting ventricle. The objectives were to determine the range of pneumatic pressures and time required to completely fill and empty the pediatric ventricular assist device under various physiologic conditions, simulate reductions in ventricular contractility and blood volume, and provide data for validation of the mock circulatory loop. A 15-kg goat was used. The cannulation was achieved via left thoracotomy from the left ventricle to the descending aorta. The pump rate and systolic duration were controlled manually to maintain complete filling and ejection. The mean ejection time ranged from 280 ms to 382 ms when the systolic pressure ranged from 350 mm Hg to 200 mm Hg. The mean filling time ranged from 352 ms to 490 ms, for the diastolic pressure range of -60 mm Hg to 0 mm Hg. Esmolol produced a decrease in left ventricular pressure, required longer pump filling time, and reduced LVAD flow.     

In vitro evaluation of multiobjective hemodynamic control of a heart-assist pump

Ventricular assist devices now clinically used for treatment of end-stage heart failure require responsive and reliable hemodynamic control to accommodate the continually changing demands of the body. This is an essential ingredient to maintaining a high quality of life. To satisfy this need, a control algorithm involving a trade-off between optimal perfusion and avoidance of ventricular collapse has been developed. An optimal control strategy has been implemented in vitro that combines two competing indices: representing venous return and prevalence of suction. The former is derived from the first derivative of diastolic flow with speed, and the latter derived from the harmonic spectra of the flow signal. The responsiveness of the controller to change in preload and afterload were evaluated in a mock circulatory simulator using a HeartQuest centrifugal blood pump (CF4b, MedQuest Products, Salt Lake City, UT). To avoid the need for flow sensors, a state estimator was used, based on the back-EMF of the actuator. The multiobjective algorithm has demonstrated more robust performance as compared with controllers relying on individual indices.     

How to produce a pulsatile flow with low haemolysis?

It is evident that a pulsatile flow is important for blood circulation because the flow pulsatility can reduce the resistance of peripheral vessels. It is difficult, however, to produce a pulsatile flow with an impeller pump, since blood damage will occur when a pulsatile flow is produced. Further investigation has revealed that the main factor for blood damage is turbulence shear, which tears the membranes of red blood cells, resulting in free release of haemoglobin into the plasma, and consequently leads to haemolysis. Therefore, the question for developing a pulsatile impeller blood pump is: how to produce a pulsatile flow with low haemolysis? The authors have successively developed a pulsatile axial pump and a pulsatile centrifugal pump. In the pulsatile axial pump, the impeller reciprocates axially and rotates simultaneously. The reciprocation is driven by a pneumatic device and the rotation by a dc motor. For a pressure of 40 mm Hg pulsatility, about 50 mm axial reciprocating amplitude of the impeller is desirable. In order to reduce the axial amplitude, the pump inlet and the impeller both have cone-shaped heads, and the gap between the impeller and the inlet pipe changes by only 2 mm, that is the impeller reciprocates up to 2 mm and a pressure pulsatility of 40 mm Hg can be produced. As the impeller rotates with a constant speed, low turbulence in the pump may be expected. In the centrifugal pulsatile pump, the impeller changes its rotating speed periodically; the turbulence is reduced by designing an impeller with twisted vanes which enable the blood flow to change its direction rather than its magnitude during the periodic change of the rotating speed. In this way, a pulsatile flow is produced and the turbulence is minimized. Compared to the axial pulsatile pump, the centrifugal pulsatile pump needs only one driver and thus has more application possibilities. The centrifugal pulsatile pump has been used in animal experiments. The pump assisted the circulation of calves for several months without harm to the blood elements and the organ functions of the experimental animal. The experiments demonstrated that the pulsatile impeller pump is the most efficient pump for assisting heart recovery, because it can produce a pulsatile flow like a diaphragm pump and has no back flow as occurs in a non-pulsatile rotary pump; the former reduces the circulatory resistance and the latter increases the diastole pressure in aorta and thus increases the perfusion of coronary arteries of the natural heart.     

磁悬浮离心式心室辅助装置的体外溶血测试**

背景：心室辅助装置已广泛应用于心力衰竭患者的治疗。虽然有不同的血泵在国外应用于临床,却很少在国内应用,主要原因是其价格太高。因此在国内研制相对价格较低的能应用于临床的自主血泵迫在眉睫。 目的：测试置入式磁悬浮离心心室辅助装置主体血泵的溶血性能。 方法：通过计算流体力学方法,对磁悬浮离心式心室辅助装置主体血泵内部流场做初步分析。血泵在后负荷100 mm Hg     (1 mm Hg=0.133 kPa)、流量5 L/min 情况下,通过体外模拟血循环系统驱动羊血测试血泵体外溶血性能,计算血泵实际标准溶血指数NIH。 结果与结论：在设计工况下计算流体力学结果显示血泵内部流线平稳,整个流道内部壁面剪切力均在68.5 Pa以下,内部静压力分布均匀,过渡平稳,没有不良区域出现。体外溶血实验测得标准溶血指数NIH值为(0.075±0.017) mg/L。提示血泵驱动叶片及内部流道设计合理,同第3代血泵相比有较好溶血性能。血泵实验期间无不良状况发生,可以进行下一步长期的动物体内实验,进而评估血泵体内血流动力学性能和血泵置入对实验动物脏器的影响。     

Pitfalls in the development of a rotary blood pump controller

The controller presents a major obstacle in the development of the rotary blood pump as a left ventricular assist device (LVAD). Clinically, LVAD flow is a good indicator in the regulation of circulatory conditions and pump flow changes, depending on pump preload and afterload. Many investigators have tried estimating pump flow by referencing the motor current. There have been pitfalls in in vitro experimental settings, however. Using a test loop with a pneumatically driven LV chamber and a centrifugal pump as an LVAD, we monitored pump flow and pressure head to evaluate the pump performance curve (H-Q curve). Under pulsatile LV conditions, the H-Q curve was a loop that changed, depending on LV contractility. The pneumatically driven LV chamber cannot mimic the Starling phenomenon, so the developed LV pressure does not change according to the LV preload. Rotary pump flow estimation is the most effective control method. In pulsatile conditions, however, the H-Q curve is a loop that changes under various LV contractility conditions, complicating determination of linear equation for calculating flow. In addition, the LV chamber in the test loop cannot mimic native heart contractility as described by Starling's law. This finding can lead to a misanalysis of the H-Q curve under pulsatile conditions.     

可植入旋转式心室辅助泵的现状及展望

可植入旋转式血泵主要包括离心泵及轴流泵;前利用离心力驱动血流时,泵转速2000～6000r／min,以非搏动血流为主,少数为搏动血流。动物实验最长存活23周。轴流泵利用高速旋转叶轮驱动血液。叶轮转速6000～20000r／min,以非搏动血流为主,最长动物实验存活6个月,近期可能应用于临床研究。同时介绍了血管内搏动性轴流泵一动力性主动脉瓣。另外还介绍了其它类型的旋转泵。并对可植入式旋转泵的研制提出了一些看法。     

Analysis of the relationship between left ventricular pressure and motor current for evaluation of native cardiac function during left ventricular support with a centrifugal blood pump

Control of the ventricular assist device (VAD) for native heart preservation should be attempted, and the VAD could be one strategy for dealing with the shortage of donors in the future. In the application of nonpulsatile blood pumps for ventricular assistance from the ventricular apex to the aorta, bypass flow and hence the motor current of the pumps change in response to the ventricular pressure change. Utilizing these intrinsic characteristics of the continuous-flow pumps, in this study we investigated whether motor current could be used as an index for continuous monitoring of native cardiac function. In study 1, a centrifugal blood pump (CFP) VAD was installed between the apex and descending aorta of a mock circulatory loop. In this model, a baseline with a preload of 10 mmHg, afterload of 40 mmHg, and LV systolic pressure of 40 mmHg was used. The pump speed was fixed at 1300, 1500, and 1700 rpm, and LV systolic pressure was increased up to 140 mmHg by steps of 20 mmHg while the changes in LV pressure, motor current, pump flow, and aortic pressure were observed. In study 2, an in vivo experiment was performed using three sheep. A left heart bypass model was created using a centrifugal pump from the ventricular apex to the descending aorta. The LVP was varied through administration of dopamine while the changes in LV pressure, pump flow, and motor current at 1500 and 1700 rpm were observed. An excellent correlation was observed in both in vitro and in vivo studies in the relationship between motor current and LV pressure. In study 1, the correlation coefficients were 0.77, 0.92, and 0.99 for 1300, 1500, and 1700 rpm, respectively. In study 2, they were 0.88 (animal no. 1), 0.83 (animal no. 2), and 0.88 (animal no. 3) for 1500 rpm, and 0.95 (animal no. 2) and 0.93 (animal no. 3) for 1700 rpm. These results suggest that motor current amplitude monitoring could be useful as an index for the control of VAD for native heart preservation.     

In vitro evaluation of the PUCA II intra-arterial LVAD

The "pulsatile catheter" (PUCA) pump is a minimally invasive intra-arterial left ventricular assist device intended for acute support of critically ill heart failure patients. To assess the hydrodynamic performance of the PUCA II, driven by an Arrow AutoCat IABP driver, we used a (static) mock circulatory system in which the PUCA II was tested at different loading conditions. The PUCA II was subsequently introduced in a (dynamic) cardiovascular simulator (CVS) to mimic actual in vivo operating conditions, with different heart rates and 2 levels of left ventricular (LV) contractility. Mock circulation data shows that PUCA II pump performance is sensitive to afterload, pump rate and preload. CVS data demonstrate that PUCA II provides effective LV unloading and augments diastolic aortic pressure. The contribution of PUCA II to total flow is inversely related to LV contractility and is higher at high heart rates. We conclude that, with the current IABP driver, the PUCA II is most effective in 1:1 mode in left ventricles with low contractility.     

Dynamic modeling of the outlet of a pulsatile pump incorporating a flow-dependent resistance

Outlet tube models incorporating a linearly flow-dependent resistance are widely used in pulsatile and rotary pump studies. The resistance is made up of a flow-proportional term and a constant term. Previous studies often focused on the steady state properties of the model. In this paper, a dynamic modeling procedure was presented. Model parameters were estimated by an unscented Kalman filter (UKF). The subspace model identification (SMI) algorithm was proposed to initialize the UKF. Model order and structure were also validated by SMI. A mock circulatory loop driven by a pneumatic pulsatile pump was developed to produce pulsatile pressure and flow. Hydraulic parameters of the outlet tube were adjusted manually by a clamp. Seven groups of steady state experiments were carried out to calibrate the flow-dependent resistance as reference values. Dynamic estimation results showed that the inertance estimates are insensitive to model structures. If the constant term was ignored, estimation errors for the flow-proportional term were limited within 16% of the reference values. Compared with the constant resistance, a time-varying one improves model accuracy in terms of root mean square error. The maximum improvement is up to 35%. However, including the constant term in the time-varying resistance will lead to serious estimation errors.     

Hemodynamic influence of tilting disc valve type on pump performance with the NIPRO-ventricular assist device

The NIPRO-ventricular assist device (NIPRO-VAD) is an external pulsatile flow pump. Formerly, Sorin Carbocast, a monoleaflet tilting disc valve (SC valve), was used at the inlet/outlet parts of the pump, but Medtronic Hall (MH valve) is now used. We studied the differences in performance among pumps with different artificial valves. Six NIPRO pumps with SC valves and six with MH valves were examined using mock circuits. The systolic flow of the pump was measured with the ultrasonic flowmeter by changing the systolic fraction. Six patients wearing the NIPRO-VAD underwent periodic pump exchange from a pump with an SC valve to the one with an MH valve. The pump blood flow was measured at pre- and post-pump exchanges using an ultrasonic flowmeter. Blood pressure, serum LDH and AST levels were also compared before and after the pump exchange. Blood flow was significantly increased by using the NIPRO-VAD with the MH valve as compared to the SC valve in vitro. Under the same drive conditions pump flow tended to increase in six patients. No difference was found in patients' blood pressure, serum LDH or AST levels when using the SC or MH valve. From these results, the hemodynamic influence on patients due to replacement of the SC valve with the MH valve in the NIPRO-VAD is considered to be insignificant.     

旋转血泵产生低溶血搏动流的方法

为减少心室辅助装置中叶轮泵输出搏动流对血液成分的破坏作用,我们将泵的入口和叶轮外形轮廓设计成锥形,研制出博动流轴流泵;并设计出扭曲形叶片的叶轮,周期性的改变叶轮的转速,研制出搏动流离心泵。理论分析和实验表明这两种类型的装置均无明显附加紊流产生,也没有对血液成分产生破坏,具有较强实用性。     

Suction detection for the MicroMed DeBakey Left Ventricular Assist Device

The MicroMed DeBakey Ventricular Assist Device (MicroMed Technology, Inc., Houston, TX) is a continuous axial flow pump designed for long-term circulatory support. The system received CE approval in 2001 as a bridge to transplantation and in 2004 as an alternative to transplantation. Low volume in the left ventricle or immoderate pump speed may cause ventricular collapse due to excessive suction. Suction causes decreased flow and may result in patient discomfort. Therefore, detection of this critical condition and immediate adaptive control of the device is desired. The purpose of this study is to evaluate and validate system parameters suitable for the reliable detection of suction. In vitro studies have been performed with a mock loop allowing pulsatile and nonpulsatile flow. Evidence of suction is clearly shown by the flow waveform reported by the implanted flow probe of the system. For redundancy to the implanted flow probe, it would be desirable to use the electronic motor signals of the pump for suction detection. The continuously accessible signals are motor current consumption and rotor/impeller speed. The influence of suction on these parameters has been investigated over a wide range of hydrodynamic conditions, and the significance of the respective signals individually or in combination has been explored. The reference signal for this analysis was the flow waveform of the ultrasonic probe. To achieve high reliability under both pulsatile and nonpulsatile conditions, it was determined that motor speed and current should be used concurrently for suction detection. Using the amplified differentiated current and speed signals, a suction-detection algorithm has been optimized, taking into account two different working points, defined by the value of the current input. The safety of this algorithm has been proven in vitro under pulsatile and nonpulsatile conditions over the full spectrum of possible speed and differential pressure variations. The algorithm described herein may be best utilized to provide redundancy to the existing flow based algorithm.     

Hydrodynamic characterisation of ventricular assist devices

A new mock circulatory system (MCS) was designed to evaluate and characterise the hydraulic performance of ventricular assist devices (VADs). The MCS consists of a preload section and a multipurpose afterload section, with an adjustable compliance chamber (C) and peripheral resistor (Rp) as principal components. The MCS was connected to a pulse duplicator system for validation, simulating a wide range of afterload conditions. Both pressure and flow were measured, and the values of the different components calculated. The data perfectly fits a 4-element electrical analogon (EA). The MCS was further used to assess the hydrodynamic characteristics of the Medos VAD as an example of a displacement pump. Data was measured for various MCS settings and at different pump rates, yielding device specific pump function graphs for water and pig blood. Our data demonstrate (i) flow sensitivity to preload and afterload and (ii) the effect of test fluid on hemodynamic performance.     

In vitro evaluation of left ventricular assistance by cannulation of both femoral arteries

The possibility of achieving effective mechanical ventricular assistance without the need for thoracotomy provides great clinical advantages. Two in vitro systems were used to assess left ventricular unloading by means of a small-diameter cannula inserted retrograde into the left ventricle by cannulation of the femoral artery. This cannula is connected to the inlet of a centrifugal blood pump (CP) that delivers the blood into the contralateral femoral artery. Steady-flow test circulation was used to pump fluid in a closed loop from a reservoir through the test cannula back into the reservoir. Pressure drops over cannulae with inner diameters of 4, 5, 6, 7, and 8 mm at flows of 2, 2.5, 3 L/min, against a pressure of 60, 80, 100, and 120 mmHg were calculated. A stationary pressure drop of 120 mmHg was measured at a flow of 3 L/min through a 100 cm cannula with an inner diameter of 6 mm. The second system was a pulsatile mock circulation composed of an atrial and an arterial reservoir linked by a pneumatic prosthetic ventricle. This system was coupled with a 100 cm cannula, 6.1 mm inner diameter, which was passed across the outflow valve of the pulsatile prosthetic ventricle and connected to a CP. Fluid was withdrawn from the ventricle and pumped back into the arterial reservoir. Pulsatile pressure drop over the cannula was measured at different CP flows for increasing systolic ventricular pressure; heart unloading was quantified as a function of CP flow under baseline and failing conditions of the prosthetic left ventricle model. At a constant CP flow the pressure drop over the cannula increased with the pulsatility inside the ventricle. The work of the prosthetic ventricle was reduced by more than 50% when the CP pump was set to 3 L/min; at the same flow setting, when the situation of a failing left ventricle was simulated, the CP was able to take over all the work of the prosthetic ventricle, establishing a stationary flow and a 25% higher mean aortic pressure. This approach to left ventricular assistance may have significant clinical relevance.     

Left ventricular assist device for pediatric postcardiotomy cardiac failure

Children with postcardiotomy heart failure who are unresponsive to maximal medical management have limited options for survival. Short-term mechanical circulatory support, such as with extracorporeal membrane oxygenation and ventricular assist devices, has assumed an expanding role in the care of these patients by providing a bridge to recovery. This report describes the use of left ventricular assist devices with centrifugal pumps in five pediatric cases (weight <15 kg) with postcardiotomy heart failure.