搏动式血泵的电磁驱动装置设计及可行性研究

为了实现搏动式血泵的驱动,设计了一种新型电磁驱动装置。基于模拟体外循环实验对装置进行相关的可行性实验研究。研究结果表明:驱动线圈结构设计过程科学合理,且驱动力规律满足血泵驱动要求;平均灌注压与驱动电流的线性拟合方程为y=33. 074x+6. 6563,R^2=0. 9784,表明该驱动装置能够按照设定的压力值输出搏动流以满足实际应用需求。装置的驱动效率为21. 83%。研究表明我们所设计的新型驱动装置能够作为搏动式血泵驱动。     

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。     

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。     

一种智能化生理性心脏支持系统的设计与初步实验研究

报道了对一种用于急性心肌梗塞过渡治疗的心脏支持系统。设计用于代替心脏功能、简便易用的智能化体外循环装置。包括两个独立的机械泵和泵室、感应和控制系统、膜肺、单向活瓣等主要结构。采用血压和心电图反馈控制机制维持动脉血压和协调心脏收缩与泵输出。在体外测试了搏动泵的工作状况,并对整个系统的运行进行了模拟实验。动物实验证实可获得搏动性动脉波,在心跳停止时可给予心脏足够的血供。     

往复式电磁铁驱动搏动式血泵的可行性研究

目的为了得到更适合血液循环的动力装置,提出一种用于体外膜肺氧合(extracorporeal membrane oxygenation,ECMO)系统由电磁铁驱动的搏动式血泵,并研究其可行性。方法首先利用电磁原理设计出电磁驱动机构,主要部件包括对称的两个电磁铁和压簧,两个电磁铁交替通电下使得动铁芯往复运动;利用容积控制原理,泵腔在动铁芯的驱动下收缩舒张;然后根据上述原理设计出血泵模型,包括电磁驱动部件和泵腔;最后建立包括血泵、电路控制部分、示波器、加速度传感器、输入输出管路和储液池的试验台,对血泵模型进行驱动力和流量输出测试。结果血泵模型在通电电压7～12 V时动铁芯的初始驱动力为2. 97～8. 00 N。血泵模型产生的初始驱动力与工作电压呈正相关非线性关系,当通入电压12 V时血泵模型初始驱动力满足要求。当前压与后压为0、频率80次/min、工作电压7～12 V时的流量输出为0. 97～3. 81 L/min。当前压与后压为0,工作电压12 V、频率60～90次/min时的流量输出为3. 1～3. 8 L/min。当工作电压12 V、频率80次/min、前压0～40 cm H2O和后压50～110 cm H2O时的流量输出为0. 55～3. 59 L/min。血泵流量与工作电压和频率呈正相关,与后压呈负相关,与前压无显著性相关。结论往复式电磁铁驱动搏动式血泵基本满足ECMO临床要求,具有广泛的应用前景,对体外循环血泵的发展具有重要意义,但仍需进一步研究和改进。     

电磁搏动式血泵的温度场仿真分析

电磁搏动式血泵是基于电磁感应原理制作而成的，长时间通电工作会引起血泵升温。如果血泵温度过高会使血泵损坏，甚至可能使泵内循环血液温度过高，对血液成分造成破坏甚至威胁生命，因此研究电磁搏动式血泵温度，对其进行温度场分析是必要的。通过使用有限元分析软件对血泵进行温度场分析，可以直观观察血泵工作温度。仿真结果表明，在设定电磁搏动式血泵工作1 h情况下，血泵温度最高处在驱动绕组处，最高温度为100.3℃，泵内与37.0℃循环血液接触面的温度变化不大,最高温度为37.5℃，因此电磁搏动式血泵不会对血液成分造成破坏，但是需要对驱动绕组进行降温处理以免破坏血泵,对循环血液造成影响。     

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。     

短期辅助用直流电磁驱动搏动式血泵设计与测试

设计一种直流电磁驱动搏动式血泵并测试样机性能指标。首先,提出一种通过直流螺线管使永磁体进行往复直线运动的驱动方法,并通过螺线管内部磁场的数值模拟设计内部磁场趋于匀强磁场的补偿螺线管结构,结合两者设计直流电磁驱动搏动式血泵。然后,通过制作样机并搭建加速度实验台,测量接入不同直流电流时血泵样机可提供的磁力驱动力,并验证通电螺线管发热问题。最后,搭建流量实验台,在前、后负荷范围分别为5~30和50~80 mmHg的情况下,测量血泵样机的流量性能指标。血泵样机提供的磁力驱动力与电流呈正相关线性关系,并且在接入2.7 A的电流时,其数值大小即可满足驱动要求;在接入的直流电流为2.7 A且血泵驱动频率为80 次·min^-1时,一方面通电螺线管与血液接触的内表面温度上升1 ℃后平稳在27 ℃,另一方面除了前、后负荷压差达到70 mmHg及以上,血泵样机流量均大于3.0 L·min^-1。该直流电磁驱动血泵满足离体器官灌注和体外循环短期辅助的临床要求,且对体外循环血泵的发展具有重要意义。     

体外循环用血泵研究进展

本文在阐述体外循环原理及临床意义的基础上,简单介绍了体外循环用血泵的原理、特点以及关键技术评价指标,重点分析了离心血泵的发展历史,及二代、三代离心血泵磁力驱动的工作原理和特点。第二代血泵采用圆盘形磁力耦合器驱动方式,其永磁体采用组合拉推式结构。第三代血泵是在第二代血泵的基础上增加了磁悬浮系统。最后展望了体外循环用离心血泵的发展趋势。     

搏动泵血流参数的优化

在心肺旁路时,通常很重视有效搏动流和无效搏动流之差。必须选取适当的因子。诸如射血间期、蜂值流量等,以达到使毛细血管保持开放並避免血细胞的过度机械损伤所需要的血流波能量成分。同时还必须考虑会显著改变脉搏的动脉管道和主动脉插管的影响。我们研制了一种用于小儿体外循环的、微机控制的、气动驱动的搏动泵。为了达到血流参数的优化,必须认真考察主动脉插管所引起的能量损     

Pulsatile ECMO and VAD: a dual use of a new device in pediatric cardiac patients

The purpose of this investigation was to present the first European clinical experience with the new MEDOS DELTASTREAM DP1 used in pulsatile extracorporeal membrane oxygenation (ECMO) or ventricular assist device (VAD) options in the pediatric population. Between January 2002 and April 2006, 11 patients required ECMO and 5 patients received a left VAD (LVAD) in the San Vincenzo Hospital. Indications were postcardiotomy heart failure in 15 patients and fulminant myocarditis in one patient. ECMO was established in all patients by cannulation of the right atrium and ascending aorta. LVAD was instituted by cannulation of the left atrium and ascending aorta. The DP1, an extracorporeal rotary blood pump, was used as an ECMO and an LVAD device. The pump features a diagonal-flow impeller and can be used for both continuous and pulsatile modes of perfusion. Priming volume of the pump was approximately 30 ml, with a flow rate of up to 8 l/min. Ten patients were discharged from ECMO and four from VAD. In the ECMO group, one patient died of peritonitis while on ECMO and two patients died on days 3 and 4 after weaning because of persistent pulmonary hypertension and major neurologic complications. In the VAD group, one patient died of low output syndrome 9 days after weaning. A 12-year-old patient was successfully given transplantation on day 8 of ECMO support and discharged on day 30 after heart transplant. All other patients were discharged. Three pumps were changed for pump failure and one pump was electively replaced because of improper anticoagulation management. No other thromboembolic adverse events occurred. Our results suggest that the MEDOS DELTASTREAM DP1 pulsatile pump system can be used as an ECMO or a VAD support. The opportunity to utilize pulsatile flow in postcardiotomy cardiogenic shock significantly improved the outcomes by producing more physiologic hemodynamics and superior end organ function. Easy implantation and simple management of this device represents the major advantage.     

完全磁悬浮心室辅助装置的体外模拟循环系统实验研究

目的研究我国自主研发的第3代完全磁悬浮心室辅助装置(CH-VAD)对于心衰患者的循环辅助效果。方法建立一套体外模拟循环系统(mock circulatory system,MCS)。该系统能够模拟人体健康休息状态以及心力衰竭状态,并与CH-VAD协同工作,测试CH-VAD在连续流状态下的辅助效果。另外,对CH-VAD的搏动流控制方法进行测试,该模式采用正弦波速度波形,使CH-VAD的运行与MCS心室周期同步。结果 CH-VAD在正常连续流状态下能够使心衰状态的血流动力学参数(动脉压、心排量)恢复到正常范围。初步的搏动流测试结果显示,当前的速度搏动幅值对血流动力学影响较小,搏动流状态下与连续流状态所对应的平均动脉压、动脉脉压、平均心排量与心排量波形等差异不大。结论 CH-VAD能够通过搏动控制器产生一定程度的速度搏动,提供足够的心室辅助,并可以进一步改良优化,提供符合生理条件的搏动血流。所研制的MCS能够提供心室辅助装置以及其他机械循环辅助装置一个有效、可控的体外测试平台,是机械循环辅助装置设计、优化和验证的重要工具。     

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.     

The enabler cannula pump: a novel circulatory support system.

BACKGROUND: The enabler circulatory support system is a catheter pump which expels blood from the left or right ventricular cavity and provides pulsatile flow in the ascending aorta or pulmonary artery. It is driven by a bedside installed pulsatile driving console. The device can easily be implanted by a minimal invasive approach, similar to the Hemopump. PURPOSE: To demonstrate the hemodynamic performance of this new intracardiac support system. METHODS: In a series of 9 sheep, hemodynamic evolutions were recorded in various conditions of myocardial contractility (the non-failing, the moderately failing and the severely failing heart). Heart failure was induced by injection of microspheres in the coronary arteries. RESULTS: Introduction of the cannula through the aortic valve was feasible in all cases. Pump flow by the enabler was gradually increased to a maximum of 3.5 L/min. Diastolic (and mean) aortic blood pressure is significantly increased in the non-failing and moderately failing condition (counterpulsation mode). In heart failure, cardiac output is significantly increased by the pump (p < 0.0001). A drop in left atrial pressure (indicating unloading) is achieved in all conditions but reaches significant levels only during heart failure (p=0.0068). CONCLUSIONS: This new circulatory support system contributes to stabilization of the circulation in the presence of cardiac unloading. In heart failure it actually supports the circulation by increasing cardiac output and perfusion pressure.     

A pulsatile control algorithm of continuous-flow pump for heart recovery

The intra-aorta pump is a novel continuous flow (CF) left ventricular (LV) device. According to literatures, the pulsatile flow LV device can provide superior LV unloading and circulatory support compared with CF LV assist devices at the same level of ventricular assist device flow. Therefore, a pulsatile control algorithm for the intra-aorta pump is designed. It can regulate the pump to generate pulsatile arterial pressure (AP) and blood flow. A mathematic model of the cardiovascular-pump system is used to verify the feasibility of the control strategy in the presence of LV failure. The surplus hemodynamic energy (SHE), pulsatile ratio (PR), and pulsatile attenuation index (PAI) are used to evaluate the pulsatility of AP and blood flow. The SHE is 8,012.0 ergs/cm(3) by using the pulsatile control strategy (PCS) compared with 5,630.0 ergs/cm(3) by failing heart without support. The PR is 0.302 in the PCS vs. 0.315 in failing heart without support. Meanwhile, the PAI is 85.9% in the PCS compared with 69.7% in failing heart without support. The results demonstrate that the presented control strategy can maintain the pulsatility of AP and blood flow. Moreover, the pulsatile controller provides notably LV unloading. To test the response of the controller to the change of blood demand of patients, another simulation is conducted. In this simulation, the peripheral resistance is reduced to mimic the status of a slight physical active; the Emax is increased to simulate the ventricular contractility recovery. The simulation results demonstrate that the proposed control strategy can automatically regulate the pump in response to the change of the parameters of the circulatory system. To test the dynamic character of the intra-aorta pump, an in vitro experiment is conducted on an in vitro experiment rig. The experimental results demonstrate that the intra-aorta pump can achieve the pulsatile pump speed calculated by the pulsatile controller. The PCS is feasible for the intra-aorta pump. As a key feature, the proposed control strategy provides adequate perfusion in response to the change of blood demands of patients, while restoring the pulsatility of AP and blood flow.     

Development of a new pulsatile extracorporeal life support device incorporating a dual pulsatile blood pump

A new pulsatile extracorporeal life support device (ECLS) has been developed, designed to sustain pulsatile blood flow during emergency cardiopulmonary resuscitations and cardiopulmonary operations. This device features two identical pulsatile pumps that operate alternately and can therefore provide blood inflow in a more uniform manner than similar systems featuring a single-pump configuration. In order to confirm the presumed benefits of this newly-developed dual pulsatile pump configuration, we have conducted a series of in vitro experiments designed to compare the properties of the new system with a single pump system, specifically with regard to pump delivery rate and active filling efficiency. Our results reveal that the dual pump configuration can, indeed, deliver a higher flow than can the single-pump system, and exhibits an active filling efficiency superior to that of the single-pump configuration. We performed a series of animal experiments to measure the pulsatility of the dual-pump configuration in terms of equivalent energy pressure (EEP). In order to measure EEP, we measured femoral arterial pressure and pump outflow. The results of our animal experiments revealed that the newly-developed pulstile ECLS exhibits sufficient pulsatility in terms of the EEP considerations.     

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.     

Development and evaluation of endurance test system for ventricular assist devices

We developed a novel endurance test system that can arbitrarily set various circulatory conditions and has durability and stability for long-term continuous evaluation of ventricular assist devices (VADs), and we evaluated its fundamental performance and prolonged durability and stability. The circulation circuit of the present endurance test system consisted of a pulsatile pump with a small closed chamber (SCC), a closed chamber, a reservoir and an electromagnetic proportional valve. Two duckbill valves were mounted in the inlet and outlet of the pulsatile pump. The features of the circulation circuit are as follows: (1) the components of the circulation circuit consist of optimized industrial devices, giving durability; (2) the pulsatile pump can change the heart rate and stroke length (SL), as well as its compliance using the SCC. Therefore, the endurance test system can quantitatively reproduce various circulatory conditions. The range of reproducible circulatory conditions in the endurance test circuit was examined in terms of fundamental performance. Additionally, continuous operation for 6 months was performed in order to evaluate the durability and stability. The circulation circuit was able to set up a wide range of pressure and total flow conditions using the SCC and adjusting the pulsatile pump SL. The long-term continuous operation test demonstrated that stable, continuous operation for 6 months was possible without leakage or industrial device failure. The newly developed endurance test system demonstrated a wide range of reproducible circulatory conditions, durability and stability, and is a promising approach for evaluating the basic characteristics of VADs.     

循环系统模拟中的后负荷选择

目前国内外现有人工心脏瓣膜测试装置（或称循环系统模拟装置）普遍存在再现人体生理条件差以及测试结果客观性和可比性差的弊病。本文从分析和克服这些弊病出发，放弃仅以压力和流量波形作为判断系统是否正常的传统做法，以血管输入阻抗作为心室后负荷的恰当量度筛选出具有较强再现人体生理条件的后负荷系统，并在此基础上，研制出能较好模拟人体循环系统特性的具有标准后负荷的循环系统模拟装置。     

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。