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     

一种新型抗钙化处理的人工生物瓣膜流体力学性能

目的 评价一种新型生物瓣膜的体外流体力学性能,并与传统生物瓣膜及机械瓣膜进行比较.方法 将测试瓣膜分成三组:新型生物瓣组(GA SOB处理牛心包瓣),传统生物瓣组(单纯GA处理牛心包瓣),机械瓣组(双叶瓣),每组分别选21号、25号、29号三种型号,采用清华大学TH-1200脉动流测试仪,按照ISO5840瓣膜检测标准进行流体性能检测,包括跨瓣压差、返流量、返流百分比及有效开口面积,并进行组间的分析、比较.结果 新型生物瓣膜的前向流跨瓣压差较传统生物瓣小17%～30%,较机械瓣小23%～50%;新型生物瓣的有效开口面积较传统生物瓣和机械瓣分别大13%～37%和36%～50%;新型生物瓣的返流量较传统生物瓣大1.2～2.0 mL,约3%～6%;较机械瓣小0.9～2.8mL,约1.3%～5%.结论 新型人工生物瓣膜具有良好的血流动力学性能.     

介入瓣膜瓣中瓣模式下耐久性能测试及评价

目的随着之前植入外科人工生物心脏瓣膜患者瓣膜毁损的病例增加,介入瓣膜瓣中瓣越来越多地被用于临床。由于其临床应用时间不长,目前没有长期临床数据可以参考,故实验采用体外加速方法,对一种介入瓣膜瓣中瓣耐久性能进行测试及评价。方法将23 mm、27 mm、29 mm 3个规格(牛心包材质)介入瓣膜作为瓣中瓣分别安装在23 mm、27 mm、29 mm对应规格外科生物心脏瓣膜中,通过预扩达到相同的内径后进行体外加速疲劳耐久性能测试,每5 000万次对其脉动流性能进行测试。2.0亿次疲劳测试后,对瓣叶进行热力学分析、双光子共聚焦显微镜下观察瓣叶胶原纤维结构。结果经过2.0亿次耐久性能测试,介入瓣膜瓣中瓣平均跨瓣压差无显著变化[23 mm:1.92～1.98 kPa(14.4～14.9 mmHg);27 mm:0.92～1.64 kPa(6.9～12.3 mmHg);29 mm:0.72～1.02 kPa(5.4～7.4 mmHg)],有效瓣口面积基本一致(23 mm:1.45～1.66 cm2;27 mm:1.88～2.17 cm2;29 mm:2.24～2.54 cm2),反流百分比减小(23 ...     

起旋式人工主动脉瓣构型设计及血流动力学评价

目的 设计一种附起旋功能的双叶机械瓣,通过改善其血流状态预防术后并发症。 方法 基于导流片式局部起旋器结构,将瓣叶作为导流叶片,并定义瓣叶包角以探究具有较优血流动力学特性的瓣膜构型。 应用有限元分析软件,对心缩期峰值流量状态下的主动脉流场进行仿真,螺旋性、壁面切应力分布等血流动力学特征。 结果 相较于对照瓣膜,起旋瓣具有更大的有效开口面积与更小的跨瓣压差,一定瓣叶包角范围内的起旋瓣能促进右手螺旋流的生成,并使血流趋向流道中心;起旋瓣壁面切应力分布也更加均匀,具有较少的低应力区与高应力区,壁面切应力峰值也相对较小。 针对研究中的主动脉模型,具有最优血流动力学特性的瓣叶包角为 15° ~ 20°。 结论 该新型人工主动脉瓣能调节主动脉内的血流特征,降低主动脉瓣置换术引起主动脉扩张与主动脉瘤的风险,对未来机械瓣构型设计具有指导意义。     

心室流腔角度对主动脉瓣影响的脉动流实验研究

目的探究左心室流腔与主动脉轴线所呈角度对主动脉瓣力学性能的影响。方法依据从华中科技大学同济医学院附属协和医院获得的患者CT图像上的心室流腔角度大小,通过3D打印技术制作心室流腔角度分别为0°、16.5°和30°的3组主动脉根部模型。然后将人工生物瓣安装在主动脉根部模型上,在Vivitro心脏-血管模拟实验系统中进行不同心输出量条件下的脉动流实验。心率设定为70次/min,脉动流流动速率分别为2、3、4、5、6、7 L/min的条件下,测试瓣膜的跨膜压差、反流比和有效开口面积。在每个脉动流流动速率条件下测试10次,取平均值。结果不同心室流腔角度模型之间,生物瓣的跨膜压差存在差异但均符合国家标准GB 12279—2008/ISO 5840:1996,即小于10 mmHg(1 mmHg=0.133 k Pa)。对于心输出量较低的情况,较小的心室流腔角度有助于反流比的下降,较大的心室流腔角度有助于增大瓣膜的有效开口面积;而对于心输出量较高的情况,较小的心室流腔角度有利于瓣膜有效开口面积的增大。结论手术时,医生可根据患者的各项参数大小选择合适的心室流腔角度。     

保留相同瓣下结构比较不同人工瓣膜下游湍流剪应力的差异

背景：保留瓣下结构可引起瓣膜下游血流受阻,目前有关保留瓣下结构不同人工瓣膜下游血流受阻情况的定量研究尚不深入。 目的：比较保留相同瓣下结构、不同类型人工瓣膜下游血流动力学性能的优劣。 方法：按常规二尖瓣置换方法,在全麻气管插管体外循环下建立标准的猪二尖瓣置换模型。按未保留瓣下结构、保留后瓣瓣下结构以及保留全瓣瓣下结构3种术式处理猪的二尖瓣及其瓣下结构,置换的瓣膜类型为单叶机械瓣膜、双叶机械瓣膜和生物瓣膜。采用多普勒超声结合计算机图像分析技术,对猪保留相同瓣下结构的不同类型的人工瓣膜下游湍流剪应力进行体内定量实验。 结果与结论：未保留瓣下结构的单叶双叶机械人工瓣膜下游血流动力学性能相当,均较生物瓣膜差。保留相同瓣下结构的不同类型人工瓣膜置换后其下游的血流动力学性能以生物瓣膜最佳,双叶机械瓣膜次之,单叶瓣膜最差。     

股静脉瓣膜的临床应用解剖

目的:为原发性股静脉瓣膜功能不全的诊治和构建组织工程静脉瓣膜提供形态学基础.方法:26例(52侧)成人尸体的股静脉标本等分为远侧、中间、近侧1/3段,在手术显微镜下解剖观察和测量相关数据,并对股静脉瓣膜进行 Masson三色改良染色和 H-E染色.结果:股静脉瓣膜数为(3.81±1.44)个,瓣膜以半月形双叶瓣为主,瓣膜方位除近段以前后位为主外,其余两段无显著性差异.瓣膜腔面和窦面均覆着一层内皮细胞,在两层内皮细胞之间为大量的胶原纤维,腔面内皮下覆着一弹力纤维带.结论:在临床行静脉瓣膜成形术时,应保证瓣叶的形态规则和闭合严密,以维持其正常的血流动力学;在构建组织工程瓣膜时,半月形双叶瓣或三叶瓣为最佳形态.     

一种新型干性生物瓣膜耐久性能体外测试及评价

随着生物技术的发展,近年来出现了通过覆盖钙结合位点的牛心包处理技术,并以此为瓣叶材料制备出干性生物瓣膜。由于干性生物瓣膜临床应用时间短,尚缺少长期耐久性数据。本研究采用体外加速方法,对一种干性生物瓣膜耐久性能进行测试及评价。选取23和32 mm这两个规格干性生物瓣膜进行体外耐久性能测试。通过瓣膜脉动流实验、瓣叶热力学分析和显微镜下胶原纤维观察,对其耐久性能进行评价。经过2亿次循环(模拟临床使用5年),干性生物瓣膜流体力学性能无明显变化,其中23 mm规格干性生物瓣膜平均跨瓣压差有所升高,但仍处于同规格生物瓣膜较低水平;32 mm规格干性生物瓣膜平均跨瓣压差几乎没有变化。有效瓣口面积基本一致,返流百分比无明显变化,说明干性生物瓣膜未发生明显的狭窄和返流,能量损失无明显变化,说明瓣膜的效能无明显降低。瓣叶材料的热力学变性温度由96.6℃降至91.2℃;在双光子共聚焦显微镜下观察,同样测试条件下亮度变暗,但胶原纤维形状未发生变化,仍是卷曲的立体结构,说明胶原纤维含量降低,化学键部分丢失,与热变性温度表现一致。干性生物瓣膜耐久性能实验后,微观结构发生一定变化,但仍具有良好的流体力学性能。     

下肢深静脉瓣膜的应用解剖

在30具成人尸体上,对60侧股静脉,胸静脉、股深静脉、胫前静脉,56侧胫后静脉,58侧腓静脉的瓣膜进行了观察,深入研究了各段静脉瓣膜的出现率、数目、形态、分布和位置。单侧下肢深静脉瓣膜总数平均值为48.61个。绝大多数瓣膜为双叶瓣(99.34%±0.14%),极少数为单叶瓣(0.61±0.14%),三叶瓣罕见(0.03±0.03%)。双叶瓣大部分位于静脉的前、后壁(88.78±0.58%),少部分位于静脉的左、右壁(11.21±0.58%);单叶瓣位于静脉的后壁;三叶瓣位于静脉的右、后、右壁。     

人工血泵中的疲劳问题

在长时间的动物试验中,人工血泵的耐久性是头等重要的。因为这方面的故障会使实验立即终止。气动血泵中最关键的部件是它的隔膜及瓣膜。心脏瓣膜在临床上已广泛试用,而选择适宜的人工心脏隔膜材料,在世界范围内仍然是一个未解决的问题。血液相容性、高水平的机械强度、尤其是在动态交变应力下的耐疲劳特性是对隔膜材料最基本的要求。而隔膜的设计及其加工制作技术也对这些性质有强烈影响。     

Design improvement of the jellyfish valve for long-term use in artificial hearts

In a previous communication, we reported a leaflet fracture in a Jellyfish valve that was incorporated into a blood pump, after a 312-day animal implant duration. Subsequent finite element analysis revealed that the fracture location was consistent with an area of maximum strain concentration. Therefore, the aim of this study was to improve the durability in the light of these findings. Based on the engineering analysis results, a new valve seat having a concentric ring of 0.5-mm width, located at a radius of 7.0 mm, was designed and fabricated. Accelerated fatigue tests, conducted under the conditions recommended by ISO 5840, demonstrated that the durability of this new prototype was extended by a factor of 10, as compared to the original valve. Moreover, further finite element analysis indicated that the maximum equivalent elastic strain of the proposed new valve was reduced by 52.3% as compared to the original valve. Accordingly, it has been confirmed that the modified Jellyfish valve is suitable for use in long-term artificial hearts.     

Design and in vitro performance of a novel bileaflet mechanical heart valve prosthesis

Design and in vitro performance of a novel bileaflet mechanical heart valve prosthesis are presented. The novel heart valve exhibits three main design characteristics: (i) The leaflets form a Venturi passage in open position. Thus, a beneficial pressure distribution is obtained and the leaflets are stabilised in opened position. (ii) The orifice inlet is nozzle-shaped. Flow is convectively accelerated and flow separation at the orifice inlet is avoided. (iii) The hinge design facilitates an additional axial movement of the leaflets and leads to a self cleaning effect and enhances washout of the hinges. The design of the leaflet hinges is of main importance for the functional reliability and durability of mechanical heart valves. After manufacturing first prototypes from titanium and polymeric materials the hydrodynamic performance was evaluated according to ISO 5840 and FDA guidelines. Hydrodynamic performance is comparable with the results of commonly available bileaflet mechanical heart valve prostheses. Initial durability tests showed suitable material couples for further long term studies.     

20mL小儿罗叶泵的动物存活实验

目的 采用自行研制的20 mL小儿罗叶泵行动物存活实验,明确其对血细胞和重要器官的影响,探讨临床应用的可行性.方法 健康山羊6只,体重（18±3.3）kg.经左侧第5肋间进胸,以左室心尖及降主动脉的插管方式建立左心辅助循环.止血关胸,清醒后拔除气管插管,动物置于专用饲养笼内.辅助期间持续静脉给予肝素抗凝,维持激活全血凝固时间（activated clotting time,ACT）在180～250 s.经颈动、静脉置管监测中心静脉压和血压.在辅助前,辅助后1 h、3h、6 h、10 h、16 h、24 h及存活期间每24 h监测血浆游离血红蛋白,在辅助前及存活期间每24 h检测血常规、肝肾功能、凝血指标.实验结束时取动物心、肝、肾、肺观察病理变化.结果 开胸后插管时发生顽固性室颤死亡1只,其余5只成功进行存活实验,平均存活时间（79.8±60）h.其中因栓塞死亡1只,胸腔出血、肺部感染死亡1只,肝素连接管脱落出血致失血性休克1只,反复气胸、ACT过高致脏器出血1只.1只山羊在存活至预定的7 d时,再次麻醉插管,开胸撤离辅助装置,关胸后顺利拔除气管插管,动物存活.辅助过程中肝素抗凝剂量25～35u/（kg＊h）,所维持的ACT具足够的抗凝效果.中心静脉压、平均动脉压、肝肾功能在辅助前后无明显变化.血浆游离血红蛋白由辅助前的（2.227±1.321）mg/dL升高到辅助72h的（8.873±2.510）mg/dL,二者相比有统计学差异,但在正常生理值范围内.除第1例因抗凝不足产生肾栓塞外,其余4例心、肝、肾、肺的病理检查均无栓塞.结论 20mL小儿罗叶泵血液相容性好,对肝肾功能无不良影响,具备用于临床的条件.     

Effects of leaflet geometry on the flow field in three bileaflet valves when installed in a pneumatic ventricular assist device

Our group is currently developing a pneumatic ventricular assist device (PVAD). In this study, in order to select the optimal bileaflet valve for our PVAD, three kinds of bileaflet valve were installed and the flow was visualized downstream of the outlet valve using the particle image velocimetry (PIV) method. To carry out flow visualization inside the blood pump and near the valve, we designed a model pump that had the same configuration as our PVAD. The three bileaflet valves tested were a 21-mm ATS valve, a 21-mm St. Jude valve, and a 21-mm Sorin Bicarbon valve. The mechanical heart valves were mounted at the aortic position of the model pump and the flow was visualized by using the PIV method. The maximum flow velocity was measured at three distances (0, 10, and 30 mm) from the valve plane. The maximum flow velocity of the Sorin Bicarbon valve was less than that of the other two valves; however, it decreased slightly with increasing distance it the X-Y plane in all three valves. Although different bileaflet valves are very similar in design, the geometry of the leaflet is an important factor when selecting a mechanical heart valve for use in an artificial heart.     

A new hypothesis on the mechanism of calcification formed on a blood-contacted polymer surface

Calcification on a blood-contacting polymer surface in an artificial heart is one of the most serious problems. Recently, we maintained a goat with a total artificial heart (AH) for 532 days without systemic anticoagulation. Sactype blood pumps coated with segmented polyurethane and incorporating jellyfish valves, thin polymer membrane valves, were used in the experiment. The pump was exchanged for a new one on the 312th day on the left side and the 414th day on the right side. They were analyzed with a scanning electron microscope (SEM) and an X-ray microanalyzer. The valve membrane after 312 days of pumping revealed plastic deformation expanding toward upstream between the spokes by creep fatigue with blood pressure difference when the valve closed. Calcification on the membrane was concentrated in the limited portions that received a strong stretching force: the upstream side of the membrane between the spokes and downstream side of the membrane on the spokes. Slight or no calcification was observed on the opposite side of the membrane that received a compression force, and no calcification was found on nonmoving parts such as the center of the membrane and spokes. A new hypothesis on the mechanism of calcification at the portion that received repeated stretching force was raised. The repeated stretching force would extend the polymer membrane, causing some loosening between polymer molecules and generating microgaps. The blood protein and phospholipid would invade into these microgaps, which would then attract Ca ions followed by phosphate ions to make their complexation. The hypothesis could well explain the calcification phenomena on a blood-contacting polymer surface, and gave a good clue on how to protect from calcification.     

In vitro evaluation of prosthetic heart valves: towards comparable testing.

The Laboratory of Biomedical Engineering (of the National Health Institute, technical body of the Italian Health Service) performs in vitro testing of prosthetic heart valves for mechanical characteristics of materials, fatigue life, and fluidodynamic performance. Testing of materials is directed towards the physicomechanical characterization of the structural components of the valves, e.g. elasticity and resistance to stress of biological tissues and stents. Long-term fatigue life tests are conducted by means of systems which make valves beat at more than 1200 cycles/min. These tests are preceded and followed by geometrical characterization and by steady flow testing in order to obtain information about stenosis and leakage. Special attention is devoted to pulsatile flow testing which is performed on two pulse duplicators: the Dynatek system and the system developed by the University of Sheffield. The same valve was tested with these systems according to their different possible set-ups within the general requirements established by ISO-DIS 5840. This paper presents significant measurements, taking into account their dependence on the systems adopted. Results show (a) the difficulties in comparing test results because of different operating conditions, and (b) the systems' sensitivity with regards to some parameters which affect measurements under comparable set-up conditions (FDA Interlaboratory Comparison Testing Protocol).     

Cardiac valve replacement: a bioengineering approach

The second most common major heart operation in the western world is valve replacement. Any one of the four heart valves may become either so stenotic or regurgitant that it needs to be replaced in order to restore normal heart function. Although replacement surgery of dysfunctional heart valves has a very high success rate, it can provide the surgeon with a difficult decision regarding the choice of a suitable prosthesis for the individual patient. Over the years many different types of artificial heart valves have been devised. Surgeons typically deal with a heart valve replacement by installing a mechanical prosthesis or by using a bioprosthetic valve, hand-crafted from animal tissue. Least commonly, valves can be taken from human organ donors. Mechanical valve substitutes have a long fatigue life but the central flow occluders often induce blood cell trauma. Tissue substitutes have an unimpeded central orifice when open, cause minimal cell damage but have a relatively short fatigue life, especially in children where calcification may be a major problem. More recently alternative materials, such as polyurethane, have been used in artificial heart valve design while the new concept of tissue-engineering has enhanced the prospects towards an ideal cardiac valve replacement. Today's artificial valves are designed with a better understanding of the cardiovascular system with the aid of computers. Advances in computer software have allowed simulations of fluid flows through valve substitutes, both in cardiac flow simulators and the heart itself.     

Bileaflet Aortic Valve Prosthesis Pivot Geometry Influences Platelet Secretion and Anionic Phospholipid Exposure

The clinical histories of the Medtronic Parallel (MP) and St. Jude Medical (SJM) Standard valves suggest pivot geometry influences the thrombogenic characteristics of bileaflet prostheses. This work studied the effects of various pivot geometries on markers of platelet damage in a controlled, in vitro apparatus. The Medtronic Parallel valve, two St. Jude Medical valves, and two demonstration prostheses were used to study the effects of bileaflet pivot design, gap width, and size on platelet secretion and anionic phospholipid expression during leakage flow. A centrifugal pump was used to drive blood through a circuit containing a bileaflet prosthesis. Samples were taken at set time intervals after the start of the pump. These samples were analyzed by cell counting, flow cytometry, and enzyme-linked immunosorbant assay. No significant differences were observed in platelet secretion or anionic phospholipid expression between experiments with the SJM 27 Standard regular leaker, the SJM 20 regular leaker, and the MP 27 valves. Significant differences in platelet secretion and anionic phospholipid expression were observed between a SJM 27 Standard regular leaker and a SJM 27 high leaker valve. These studies suggest that leakage gap width within bileaflet valve pivots has a significant effect on platelet damage initiated by leakage flow. © 2001 Biomedical Engineering Society. PAC01: 8719Uv, 8719Tt, 8380Lz, 8768+z     

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.