婴幼儿罗叶泵聚氨酯瓣膜的制作及功能测试

背景：现有成人罗叶泵使用机械瓣,但机械瓣膜的尺寸较大,对血液破坏较大,不适于婴幼儿心室辅助泵,故设计和制作尺寸小、血栓形成低的高分子瓣膜是目前研究的热点。 目的：设计和制作20 mL婴幼儿罗叶泵的瓣膜,并进行基本功能测试和疲劳测试 方法：通过MASTERCAM软件设计瓣膜尺寸和形状,通过制作瓣膜模具和注塑获得聚氨酯瓣膜;根据ISO5840的要求测试聚氨酯瓣膜的静止泄露、跨瓣压差和耐疲劳性能。 结果与结论：制作了聚氨酯三叶瓣膜,但注塑失败率较高;所制作的三叶瓣膜的基本功能基本符合ISO 5840的要求;聚氨酯瓣膜在连续运行1.0×107次后,20 mL罗叶泵的搏出量的变化率为5.2%。两个聚氨酯瓣膜保持完整,瓣叶无变化。说明设计并成功制作了聚氨酯三叶瓣膜;所制备的聚氨酯瓣膜能满足20 mL罗叶泵的需要,已具备了临床试验的能力。     

气动隔膜型左心辅助泵的研制

较详细地介绍了气动隔膜型左心辅助泵（罗叶泵）Ⅱ型的制作方法及体外和体内测试结果。结果显示Ⅱ型罗叶泵性能可靠，耐疲劳及血液相容性良好，符合临床应用要求。     

磁耦合驱动搏动式血泵的可行性研究

目的提出一种磁耦合驱动搏动式血泵结构并验证其可行性。方法基于磁场传递往复作用力模型以及推拉互挽式结构设计磁耦合驱动搏动血泵,通过建立磁力驱动模型,计算耦合力大小,制作样机并对样机进行体外循环模拟试验,获得压力和流量实验数据。结果采用生理盐水作为循环介质,固定后负荷,增加前负荷,血泵输出量减少,没有明显线性趋势;固定前负荷,增加后负荷,血泵输出量减少,且具有一定线性趋势。设置驱动频率为75次/min时,调节前、后负荷改变范围分别为0.665~3.990 k Pa(5~30 mm Hg)和5.320~11.970 k Pa(5~30 mm Hg),可使输出量在保证线性关系条件下达到2.0~3.1 L/min。结论该搏动式血泵流体力学特性基本满足体外膜肺循环的需要,仍需进一步研究和改进;研究结果具有重要的应用前景,尤其对替代目前临床体外膜肺氧合设备的血泵装置具有重要意义。     

国产新型叶轮泵的体外测试

在体外模拟测试台上测试新型国产叶轮泵的血流动力学特性，以便指导动物实验乃至临床应用。在一定的前负荷下，通过改变叶轮泵流入道，流出道内径及后负荷，测定在７５％的满负荷工作条件下泵的入口压、泵压、泵流量及相关血流动力学参数。结果表明：当所有管道内径为８ｍｍ，平均后负荷６０ｍｍＨｇ（１ｍｍＨｇ＝０．１３３ｋＰａ）时，泵流量为５．３２Ｌ／ｍｉｎ。后负荷９０ｍｍＨｇ时，用临床常用内径管道测试，泵流量大于１．     

新型电磁搏动式血泵的实验研究

目的探究一种新型电磁搏动式血泵的动力输出性能及血液相容性。方法首先通过建立理论模型对该血泵驱动力进行分析,并基于该模型计算出满足条件的实验驱动电压。设计体外模拟循环实验,对新型血泵的输出流量和输出压力特性及血泵的体外溶血性能进行初步实验研究。结果实验测得当血泵后负荷为73.5 mmHg(9.78 kPa, 1 mmHg=0.133 kPa)、驱动电压达到35 V、搏动频率为75/min时,实际输出的流量为3.18 L/min,可以提供高压132 mmHg(17.56 kPa)、低压66 mmHg(8.78 kPa)、平均压力98 mmHg(13.03 kPa),体外实验标准溶血指数(normalized index of haematolysis, NIH)为(0.049 15±0.003 75) mg/dL。结论该新型搏动式血泵能够满足离体器官灌注和体外循环短期辅助的临床要求,对体外循环血泵的发展具有重要意义。     

磁液悬浮离心血泵体外溶血的实验及耐久性实验

通过建立模拟循环管路系统来研究磁液悬浮离心血泵的溶血性能及机械稳定性。建立体外模拟循环管路系统,体外溶血实验中以新鲜羊血为循环介质,调节前负荷和后负荷分别为15、100 mmHg,血泵转速设定为2 900 rpm,测定血浆游离血红蛋白含量（FHb）和红细胞压积（Hct）,计算血泵标准溶血指数（NIH）;耐久性试验其他各项设定同体外溶血实验,循环介质改为甘油水溶液。在体外溶血实验中,测得磁液悬浮离心血泵NIH值为（0.0038±0.0008）g/100L;耐久性实验中血泵连续正常运转90 d,期间无卡壳、停泵等现象,电压、电流、转速稳定。该血泵溶血性能处于较高水平,机械性能稳定可靠,满足进一步进行动物实验的要求。     

基于计算流体动力学的新型电磁驱动搏动式灌注血泵泵头优化分析

目的应用计算流体动力学(computational fluid dynamics,CFD)方法对电磁驱动搏动式灌注血泵流场进行仿真分析,通过改进泵头结构改善血液在血泵的流动状态,提升其抗溶血性能。方法应用Fluent 17. 0分析泵头结构变化对泵内流场的影响,通过血液流入和流出的4次仿真实验,分析内部液体的流线分布、中轴面上的湍流动能分布、血液流经泵头的压力损失和模型表面受到的切应力。结果在4次实验中,泵头入口与出口管路对称且与对称轴的夹角α=30°时,液体流线无明显紊乱,湍流程度较低;实验1中压力损失最小,为376. 8 Pa;实验1、2中的最大切应力分别为258. 6、302. 8 Pa,符合压力损失和溶血程度等血泵生物力学性能要求。选择α=30°模型为该电磁驱动搏动式灌注血泵的泵头结构,并通过3D打印技术进行制作。结论经过对泵头的优化分析,血泵溶血性能得到改善。研究结果可以运用到新型电磁驱动搏动式灌注血泵的设计与实验中。     

左心辅助泵的制作及体外模拟实验

本实验表明了用浸渍成型法制作的气动隔膜式血泵工艺简单、易于改型,并对血泵泵壳和隔膜的厚度与强度、刚性之间的关系进行了探讨。由此制作出的血泵体外模拟实验测试结果满意、实验血泵产生的动脉腔压力波形接近生理状态,从而为以后的动物实验和临床使用提供了实验依据。     

Ⅱ型叶片轴流血泵的研制及体外流量实验

在自制Ⅰ型离心血泵和借鉴国外同类血泵的基础上 ,我们通过改变泵的整体结构、叶片角度、材料、密封方式和加工手段等 ,又自行设计和加工另一微型轴流血泵 -Ⅱ型血泵 ,它由泵体、直流无刷电机、叶轮、一对磁片、导流槽和支撑架等部件构成 ,总长度 12 5mm ,容积 147ml,材料是TC4钛合金 ,总重量 380g。我们根据不同的压力、流量输出要求 ,设计、加工出五、四、三叶片的叶轮。在模拟试验台 ,我们分别测试此泵的动力学输出、产热和密封性能。结果显示 :(1)五叶片泵在 80 0 0rpm时输出为 6 .8L/min、12 0mmHg ;根据各叶片泵的输出曲线得出 :五、四、三叶片泵的压力和流量均随着转速的升高而升高。 (2 )当前负荷为 0mmHg时 ,五、四、三叶片血泵转速80 0 0rpm流量为 5 .0L/min时 ,所对应的最大的压力约为 170mmHg、16 0mmHg和 130mmHg ,可见在同流量输出情况下 ,随着叶片数的减少压力随之降低。 (3)五、四、三叶片泵的流量、压力输出受前负荷影响较小。 (4 )血泵的效率随着转速的升高而升高。 (5 )在 12 0h的连续运转过程中 ,血泵的表面温度变化较小 ;密封性能也较好。     

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。     

In vitro testing of a novel blood pump designed for temporary extracorporeal support

Extracorporeal blood pumps are used as temporary ventricular assist devices or for extracorporeal membrane oxygenation. The ideal pump would be intrinsically self-regulating, carry no risk of cavitation or excessive inlet suction, be afterload insensitive, and valveless thus reducing thrombogenicity. Currently used technology, including roller, centrifugal, and pneumatic pulsatile pumps, does not meet these requirements. We studied a nonocclusive peristaltic pump (M-Pump) in two mock circulatory loops and compared the performance to a frequently used centrifugal pump and a modified prototype of the M-Pump (the BioVAD). The simple resistance loop consisted of the investigated pump, a fixed height reservoir at 150 mm Hg, and a variable inflow reservoir. The pulsatile circulation used a mock patient simulator with adjustable resistance elements connected to a pneumatic pulsatile pump. The M-Pump intrinsically regulated flow with changing preload, was afterload insensitive, and did not cavitate, unlike the centrifugal pump. The BioVAD also demonstrated these features and could augment output with the use of vacuum assistance. A nonocclusive peristaltic pump may be superior for short-term extracorporeal circulatory assist by mitigating risks of excessive inlet suction, afterload sensitivity, and thrombosis.     

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 controllability of the MagScrew total artificial heart system

The purpose of this study was to evaluate the in vitro responses to preload and afterload of our total artificial heart (TAH), the MagScrew TAH. The TAH consists of two blood pumps and a control logic, developed at the Cleveland Clinic, OH, and the MagScrew actuator and its electronic control system, developed by Foster-Miller Technologies, Inc., Albany, NY. Tests were performed on a mock circulatory loop, using water as a test fluid. Preload sensitivity of the Mag-Screw TAH demonstrated a Frank-Starling response to preload in automatic mode. A peak flow of 10 L/min was obtained, with a left atrial pressure of 13 mm Hg. The relationship between right atrial pressure and left atrial pressure was well balanced when tested with a left bronchial shunt flow of 5% and a range of pulmonary artery and aortic pressures. With respect to afterload response, the left pump showed a relatively low sensitivity, which allowed the pump to maintain perfusion over a wide range of aortic pressures. The right pump, on the other hand, was much more sensitive to pulmonary artery pressure, which provided a measure of protection against pulmonary congestion. The very effective physiologic response of the MagScrew TAH is believed to result from employment of a left master, alternating ejection control logic, high inherent sensitivity of the blood pumps to atrial pressure, a lower effective stroke volume for the right pump, and a scaling of right side motor ejection voltage to 80% of that used for the left side ejection.     

轴流泵式全人工心脏的体外测试及对负荷反应特性

目的 在体外模拟循环台测试轴流泵式全人工心脏的基本负荷反应特性，为探索生理性控制方案提供基础。方法 轴流泵式全人工心脏样机采用2个轴流泵共同设置在刚性外壳中，直径65 mm，长度70 mm。于模拟循环台上串联连接组成全人工心脏的2个轴流泵，在外周动脉和肺动脉阻力不变的条件下观测前、后负荷变化对心脏输出量的影响。结果 在前负荷固定不变的条件下，增加后负荷时心脏输出流量逐步下降，增大泵转速可对抗后负荷对输出量的抑制，泵转速设定为右心泵8 500 r/min、左心泵11 000 r/min时，心脏输出压力为13.3 kPa（100 mmHg）和输出量6 L/min。当后负荷增大到26.7 kPa（200 mmHg）时心输出量下降为0 L/min。在后负荷固定不变的条件下，前负荷的增加不导致心脏输出量明显改变。设定左心泵转速为11 000 r/min、右心泵转速8 500 r/min时前负荷由0.27 kPa（2 mmHg）增加到1.87 kPa（14 mmHg），流量基本维持在7 L/min。结论 轴流泵式全人工心脏对后负荷增加表现出明显的流量抑制趋势，此趋势可通过调节泵转速改善。轴流泵式全人工心脏对前负荷反应不明显，有别于自然心脏，其机制及调节意义尚待进一步研究。     

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.     

Continuous flow total artificial heart: modeling and feedback control in a mock circulatory system

We developed a mock circulatory loop and used mathematical modeling to test the in vitro performance of a physiologic flow control system for a total artificial heart (TAH). The TAH was constructed from two continuous flow pumps. The objective of the control system was to maintain loop flow constant in response to changes in outflow resistance of either pump. Baseline outflow resistances of the right (pulmonary vascular resistance) and the left (systemic vascular resistance) pumps were set at 2 and 18 Wood units, respectively. The corresponding circuit flow was 4 L/min. The control system consisted of two digital integral controllers, each regulating the voltage, hence, the rotational speed of one of the pumps. The in vitro performance of the flow control system was validated by increasing systemic and pulmonary vascular resistances in the mock loop by 4 and 8 Wood units (simulating systemic and pulmonary hypertension conditions), respectively. For these simulated hypertensive states, the flow controllers regulated circuit flow back to 4 L/min within seconds by automatically adjusting the rotational speed of either or both pumps. We conclude that this multivariable feedback mechanism may constitute an adequate supplement to the inherent pressure sensitivity of rotary blood pumps for the automatic flow control and left-right flow balance of a dual continuous flow pump TAH system.     

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.     

叶轮泵式全人工心脏的结构设计及流体力学特性

目的通过模型样机研制和流体力学特性测试．探索以叶轮式血泵为结构基础的新型可完全植入的全人工心脏。方法全人工心脏模型样机分为左心泵和右心泵2个基本单位。2血泵均采用叶轮泵．共同设置在球形外壳中。2半球形外壳由高分子材料经激光快速成型制成．球形腔内设置固定左右心泵后对合为球形外壳．表面由医用聚氨酯橡胶涂层，直径55mm，总质量150g左右。在体外模拟循环台上对左心泵和右心泵的流体力学特性进行测试．主要观测指标为泵的转速、输出压力、流量、能耗和效率。模拟循环装置由模拟左右心房、血泵、阻力调节器、流量计串联组成，采用30％甘油水溶液作为循环介质。通过调节阻力测定特定泵转速下压力和流量。结果体外模拟测试表明全人工心脏模型样机可满足血液动力学基本要求，左心泵在9000-13000r／min转速条件下可以达到5-7L／min流量和13．3kPa（100mmHg）的压力输出，右心泵在约1／2左心泵转速和4．00kPa（30mmHg）后负荷下达到相似流量．可分别满足体、肺循环的要求。在该工作负荷条件下，2血泵的总效率约为14％。结论轴流泵作为人工心脏的血泵单位．流体力学特性可达到全人工心脏的基本要求．     

Elastance-Based Control of a Mock Circulatory System

A new control strategy for a mock circulatory system (MCS) has been developed to mimic the Starling response of the natural heart. The control scheme is based on Suga's elastance model, which is implemented using nested elastance and pressure feedback control systems. The elastance control loop calculates the desired chamber pressure using a time-varying elastance function and the ventricular chamber volume signal. The pressure control loop regulates the chamber pressure according to this reference signal. Simulations and tests on MCS hardware showed that the elastance-based controller responds to changes in preload, afterload, and contractility in a manner similar to the natural heart. Since the elastance function is an arbitrary function of time, the controller allows modification of ventricular chamber contractility, giving researchers a new tool to mimic various pathological conditions which can be used in the evaluation of cardiac devices such as ventricular assist devices. © 2001 Biomedical Engineering Society. PAC01: 8719Uv, 8780-y, 8719Rr     

Long-term durability test of axial-flow ventricular assist device under pulsatile flow

A long-term durability test was conducted on a newly developed axial-flow ventricular assist device (VAD) with hydrodynamic bearings. The mock circulatory loop consisted of a diaphragm pump with a mechanical heart valve, a reservoir, a compliance tank, a resistance valve, and flow paths made of polymer or titanium. The VAD was installed behind the diaphragm pump. The blood analog fluid was a saline solution with added glycerin at a temperature of 37 °C. A pulsatile flow was introduced into the VAD over a range of flow rates to realize a positive flow rate and a positive pressure head at a given impeller rotational speed, yielding a flow rate of 5 L/min and a pressure of 100 mmHg. Pulsatile flow conditions were achieved with the diastolic and systolic flow rates of ~0 and 9.5 L/min, respectively, and an average flow rate of ~5 L/min at a pulse rate of 72 bpm. The VAD operation was judged by not only the rotational speed of the impeller, but also the diastolic, systolic, and average flow rates and the average pressure head of the VAD. The conditions of the mock circulatory loop, including the pulse rate of the diaphragm pump, the fluid temperature, and the fluid viscosity were maintained. Eight VADs were tested with testing periods of 2 years, during which they were continuously in operation. The VAD performance factors, including the power consumption and the vibration characteristics, were kept almost constant. The long-term durability of the developed VAD was successfully demonstrated.