微创介入医疗器械与材料产业现状和发展趋势

介绍国内外微创介入治疗器械与材料的现状。对心血管、脑血管、外周血管介入材料及器械的技术开发现状、临床应用及国产化现况,介绍尤为详细,并对该领域的未来发展趋势作了展望。     

桡动脉径路行冠状动脉介入治疗的现状

<正>经血管介入治疗已成为冠心病的重要诊治方法,而路径选择问题仍在不断探索中。股动脉具有血管径路较直、直径大等特点,穿刺容易,操作相对简单,但术后需较长时间卧床和患肢制动,且有发生重大血管并发症(如假性动脉瘤、动静脉瘘、下肢静脉血栓形成等)的可能[1]。近年来,随着心脏介入技术的进步及介入诊疗器械的发展,经桡动脉行冠状动脉介入性检查和治疗的优越性已被更多的介入医师所掌握并被患者所接受。现就桡动脉径路行冠状动脉介入治疗的现     

可吸收血管支架临床试用效果良好

血管支架是一种植入血管狭窄性病变区的金属丝网管状器械,用于治疗冠心病等血管性疾病,进行血管重建手术的植入器械,可支撑动脉血管开启的作用。目前应用的是裸金属支架和药物涂层支架,这两种支架都有导致血栓等风险的缺陷。     

我国5项医疗器械行业标准今年9月1日起正式施行

口刚,目家约监间反巾声多普勒胎儿心率仪》、JS坝医厅器械行业标准,并将于9月1日起正式实施。《超声多普勒胎儿监护仪》、这5项行业标准是:《超《一次性使用无菌血管内导管辅件第2部分:《一次性使用无菌血管内导管辅件第1部分:导引器械》、套针外周导管管塞》和《一次性使用输注泵》。我国5项医疗器械行业标准今年9月1日起正式施行     

一种带有旋动流引导器的新型小口径人造血管流场的数值模拟

大尺寸人造血管的临床应用已取得很大成功,但用于冠状动脉等旁路搭桥的小口径人造血管的急性血栓堵塞问题,至今仍未解决．因此,本文设计了一种可装于小口径人造血管前的旋流导引器,以期使进入人造血管内的血流产生旋动．对带有旋流导引器的人造血管内的血流流场进行了计算机数值模拟分析,并与常规人造血管内的血流流场进行了比较．数值模拟分析揭示,这种旋流导引器的确能使人造血管内的血流产生旋动,从而改变人造血管内的血流流场和流速分布,使近壁面血液的流速和壁面剪切应力得到极大提高．本研究认为,血液在人造血管壁面的流速和壁面剪切应力的提高,可抑制小口径人造血管内急性血栓的形成,从而达到提高小口径人造血管的通畅率的目的．     

综合手术救治方舱内采用不同栓塞材料救治脾破裂的对比研究

目的：探讨在战争或自然灾害等野战条件下,使用综合手术介入方舱,现场对脾脏实施快速微创介入栓塞的可行性及效果,对比分析综合手术救治方舱内采用不同栓塞材料介入救治脾破裂的适应症及有效性、安全性。方法：采用Seldinger技术,经股动脉插管至脾动脉,行数字减影血管造影术（DSA）,显示出血动脉,然后超选择插管至该动脉,经导管注入不同类型栓塞剂以栓塞出血动脉。术后观察不同栓塞剂成功封堵受损血管所用时间,封堵时造影剂用量,封堵效果。结果：手术均成功,止血效果确切,无严重并发症。术后观察2周动物无死亡。结论：综合手术救治方舱具有良好的机动性和较强的自然环境适应能力,灾难现场应用综合手术救治方舱开展血管损伤应急介入救治具有可行性。根据血管损伤的不同类型,恰当选择不同类型的栓塞剂,可以取得很好的疗效。     

血管内超声在冠状动脉疾病诊断和介入治疗中的应用

冠状动脉造影是目前公认的诊断冠状动脉病变和指导冠脉介入的金标准。然而,随着介入手术的发展,冠脉造影在评价冠脉病变方面存在的缺陷逐渐显露出来,已不能完全满足临床医生的需要。血管内超声以其优越的图像质量和空间分辨率在冠心病介入领域发挥独特的作用。作为冠脉造影的有效补充,血管内超声不仅能提供管腔和血管的直径信息,还能告知术者斑块负荷、斑块构成和血管重塑等,明确冠状动脉临界病变的性质、严重性和稳定性。此外,血管内超声还可以判断病变是否可以延迟血运重建,指导经皮冠状动脉介入的治疗策略和评估支架植入效果,有效地预防手术并发症。本文从血管内超声的概况,在冠状动脉疾病诊断和介入治疗等方面的应用进展进行了综述。     

5Fr Heartrail ST01导管在冠心病复杂病变介入治疗中的应用经验

目的:评价5Fr Heartrail ST01导管在冠心病复杂病变介入治疗中的输送支撑作用。方法:连续入选2012年10月至2014年02月南京市第一医院所有冠心病介入治疗过程中使用5Fr Heartrail ST01导管的病例,回顾性分析患者基线特征、病变特征和手术经过及器械成功率。结果:共有33例患者介入术中使用5Fr Heartrail ST01导管,剔除10例并非处理冠状动脉狭窄病变而使用5Fr Heartrail ST01导管的患者,共有23例冠心病患者采用5Fr Heartrail ST01导管增强支撑,协助球囊和/或支架通过病变。5Fr Heartrail ST01导管的器械成功率为86.96%。其中2例器械失败患者采用Tornus穿通导管补救成功;1例改用6F AL 1.0指引导管补救成功。手术成功率为91.30%,1例无法继续配合而手术失败;1例因出现非血流限制性夹层而失败。结论:5Fr Heartrail ST01导管为冠心病复杂病变介入治疗提供优秀的支撑,提高手术成功率。     

介入医师规范化培训的探讨

<正>介入治疗(interventional treatment)是介于外科、内科诊疗之间的新兴治疗方法,包括血管内介入和非血管介入治疗。介入治疗经过30多年的发展,现与外科、内科同为三大支柱性学科。目前,临床内外科医生通过各种形式的培训成为介入医师。在开展介入技术的各大型教学医院中,进修医生、研究生、科室初级医生是介入治疗一线的中坚力量,对他们介入技术及综合能力的训练和培养既影响自身的素质,也影响着介入的治疗效果及技术开展。因此,如何完善和规范介入医师的培训,是值得探讨的重要课题。作者总结带教过     

祝贺心脏手术器械研制成功

俗话说:“工欲善其事,必先利其器”,再好的雕刻家如果没有理想的雕刻工具,也不可能创造出优秀的艺术作品.外科医生好比是艺术家,整个外科手术如同制作一件工艺品,一个高水平的手术是离不开完美的器械的。我国心血管外科发展是和血管专用器械创新分不开的。心脏是人体重要的致命性器官,稍有损害将带来严重后果。所以当进行手术时必须要     

A novel technology for large vessel recanalization

Large vessels recanalization is a challenge for mechanical atherectomy devices, where the lumen debulked is close in diameter to the device crossing profile, which may be only 25% to 30% of the original lumen size; so, the procedure can restore only a fraction of the original blood flow. Moreover, small diameter lumens are prone to be repeatedly occluded after a relatively short period of time. In this article, we present a novel technology of recanalization, using a catheter-based microjet system to deliver a flux of biocompatible abrasive particles to the lesion site, resulting in microchipping of the plaque, while minimizing trauma to the vessel wall. Plaque debris is removed from the blood flow, and blood flow is restored. In contrast to rotating mechanical devices, plaque debulking can be performed up to diameters that are substantially larger than the device crossing profile, supporting superior long-term patency. As a case study, we evaluated the technology for use in the superficial femoral artery where the lesions tend to be very long and heavily calcified with high restenosis rates.     

A novel mathematical model of activation and sensitization of platelets subjected to dynamic stress histories

Blood recirculating devices, such as ventricular assist devices and prosthetic heart valves, are burdened by thromboembolic complications requiring complex and lifelong anticoagulant therapy with its inherent hemorrhagic risks. Pathologic flow patterns occurring in such devices chronically activate platelets, and the optimization of their thrombogenic performance requires the development of flow-induced platelet activation models. However, existing models are based on empirical correlations using the well-established power law paradigm of constant levels of shear stress during certain exposure times as factors for mechanical platelet activation. These models are limited by their range of application and do not account for other relevant phenomena, such as loading rate dependence and platelet sensitization to high stress conditions, which characterize the dynamic flow conditions in devices. These limitations were addressed by developing a new class of phenomenological stress-induced platelet activation models that specifies the rate of platelet activation as a function of the entire stress history and results in a differential equation that can be directly integrated to calculate the cumulative levels of activation. The proposed model reverts to the power law under constant shear stress conditions and is able to describe experimental results in response to a diverse range of highly dynamic stress conditions found in blood recirculating devices. The model was tested in vitro under emulated device flow conditions and correlates well with experimental results. This new model provides a reliable and robust mathematical tool that can be incorporated into computational fluid dynamic studies in order to optimize design, with the goal of improving the thrombogenic performance of blood recirculating devices.     

Pulse-Doppler Ultrasound and Its Clinical Application

Doppler devices can provide clinically useful information about blood flow. This paper describes how a pulse-Doppler instrument has been linked to a B-scan machine so that flow patterns in any ultrasonically accessible vessel can be monitored from the skin surface. The same transducer is used for both modes of investigation to enable accurate and reliable positioning of the sample-volume. After briefly summarizing the principles of continuous-wave and pulse-Doppler operation, the concepts and relative advantages of coherent and non-coherent detection are explained. The potential clinical uses of the pulse-echo-Doppler hybrid and Doppler devices in general are then discussed.     

Current status of the development of wireless sensors for medical applications]

Wireless near-field transmission has been a challenge for scientists developing medical sensors for a long time. Here, instruments which measure a patient's ECG, oxygen saturation, blood pressure, peak flow, weight, blood glucose etc. are to be equipped with suitable transmission technology. Application scenarios for these sensors can be found in all medical areas where cable connections are irritating for the doctor, patient and other care personnel. This problem is especially common in sport medicine, sleep medicine, emergency medicine and intensive care. Based on its beneficial properties with regard to power consumption, range, data security and network capability, the worldwide standard radio technology Bluetooth was selected to transmit measurements. Since digital data is sent to a receiving station via Bluetooth, the measurement pre-processing now takes place in the patient sensor itself, instead of being processed by the monitor. In this article, a Bluetooth ECG, Bluetooth pulse oximeter, Bluetooth peak flow meter and Bluetooth event recorder will be introduced. On the one hand, systems can be realized with these devices, which allow patients to be monitored online (ECG, pulse oximeter). These devices can also be integrated in disease management programs (peak flow meter) and can be used to monitor high-risk patients in their home environment (event recorder).     

Rheological and flow properties of blood investigated by ultrasound

Ultrasonic waves of 1-15 MHz frequencies easily propagate through soft biological tissues, thus providing qualitative and quantitative information on mechanical and flow properties of blood and red blood cell (RBC) suspensions. Two types of techniques allow to investigate blood behaviors: echographic devices via amplitude detection and Doppler effect based devices via frequency detection of the ultrasonic signal. When ever B mode serves to construct images of tissue slabs from the ultrasonic backscattering coefficient and can give qualitative information on the mechanical properties of blood, A-mode allows to quantify the ultrasonic backscattering coefficient. Ultrasonic Doppler modes also provide both qualitative and quantitative information on blood flow velocity: continuous and pulsed Doppler modes provide curves of blood flow versus time when color Doppler and power Doppler imaging visualize blood flowing in human vessels. Association of echographic and Doppler modes to investigate simultaneously structure and velocity of blood is commercially available. Some examples of results given by such ultrasonic techniques that contribute to characterize, both in vitro and in vivo, structure and flow properties of blood or red blood cell (RBC) suspensions are presented.     

A computational thrombus formation model: application to an idealized two-dimensional aneurysm treated with bare metal coils

Cardiovascular implantable devices alter the biofluid dynamics and biochemistry of the blood in which they are placed. These perturbations can lead to thrombus formation which may or may not be desired, depending on the application. In this work, a computational model is developed that couples biofluid dynamics and biochemistry to predict the clotting response of blood to such devices. The model consists of 28 advection–diffusion–reaction partial differential equations to track proteins in the blood involved in clotting and utilizes boundary flux terms to model the initiation of the intrinsic clotting pathway at thrombogenic device surfaces. We use this model to simulate the transient clot growth within a 2D idealized bifurcation aneurysm filled with various distributions of bare metal coils with similar packing densities. The clot model predicts initial clot formation to occur in areas along coil surfaces where flow is minimal and where time-averaged shear rates are the smallest. Among the six coil-filled aneurysm cases simulated, maximum thrombus occlusion ranged between 80.8 and 92.2% of the post-treatment aneurysm volume and was achieved 325–450 s after treatment. With further refinement and validation, the computational clotting model will be a valuable engineering tool for evaluating and comparing the relative performance of cardiovascular implantable devices.     

Immobilized enzyme cellulose hollow fibers: III. Physical properties and in vitro biocompatibility

The initial testing of the safety of a cellulose-heparinase hollow fiber device was assessed with respect to physical properties and in vitro biocompatibility. The material cleared urea and creatinine without passing albumin, even at high flow rates. The clearance of urea and creatinine by cellulose-heparinase was equal or slightly reduced in comparision to the cellulose device. The cellulose-neparinase device tolerance to now rates was also unchanged. In addition, scanning electron microscopy of the lumen established the uniformity of the material. The analysis of clearance rates and the scanning electron micrographs show there to be no damage to the cellulose membrane after tresyl chloride activation and heparinase immobilization. The investigation of biocompatibility in an in vitro test system with whole human blood indicated that there were no significant changes in the biocompatibility of cellulose with bound heparinase. There was no change in the level of red blood cells, white blood cells, or platelets over the course of in vitro whole blood perfusion through cellulose or cellulose-heparinase hollow fiber devices. Low levels of plasma hemoglobin and complement activation were observed with cellulose and cellulose-heparinase devices. Thus, the cellulose hollow fibers can be functionalized without any changes in in vitro performance.     

Microfluidic Study of Enhanced Deposition of Sickle Cells at Acute Corners

Sickle cell anemia is a blood disorder, known to affect the microcirculation and is characterized by painful vaso-occlusive crises in deep tissues. During the last three decades, many scenarios based on the enhanced adhesive properties of the membrane of sickle red blood cells have been proposed, all related to a final decrease in vessels lumen by cells accumulation on the vascular walls. Up to now, none of these scenarios considered the possible role played by the geometry of the flow on deposition. The question of the exact locations of occlusive events at the microcirculatory scale remains open. Here, using microfluidic devices where both geometry and oxygen levels can be controlled, we show that the flow of a suspension of sickle red blood cells around an acute corner of a triangular pillar or of a bifurcation, leads to the enhanced deposition and aggregation of cells. Thanks to our devices, we follow the growth of these aggregates in time and show that their length does not depend on oxygenation levels; instead, we find that their morphology changes dramatically to filamentous structures when using autologous plasma as a suspending fluid. We finally discuss the possible role played by such aggregates in vaso-occlusive events.     

Microfluidic modeling of cell-cell interactions in malaria pathogenesis

The clinical outcomes of human infections by Plasmodium falciparum remain highly unpredictable. A complete understanding of the complex interactions between host cells and the parasite will require in vitro experimental models that simultaneously capture diverse host-parasite interactions relevant to pathogenesis. Here we show that advanced microfluidic devices concurrently model (a) adhesion of infected red blood cells to host cell ligands, (b) rheological responses to changing dimensions of capillaries with shapes and sizes similar to small blood vessels, and (c) phagocytosis of infected erythrocytes by macrophages. All of this is accomplished under physiologically relevant flow conditions for up to 20 h. Using select examples, we demonstrate how this enabling technology can be applied in novel, integrated ways to dissect interactions between host cell ligands and parasitized erythrocytes in synthetic capillaries. The devices are cheap and portable and require small sample volumes; thus, they have the potential to be widely used in research laboratories and at field sites with access to fresh patient samples.     

Evaluation of the surface-averaged load exerted on a blood element by the Reynolds shear stress field provided by artificial cardiovascular devices

Implantable prosthetic devices can often affect the recipient's hemostasis, with possible hemolysis and thrombus formation. Since such devices can produce turbulent flow, it is important to characterize it as accurately as possible, by means of the Reynolds stress tensor. Some parameters related to the latter have been often used to provide a quantity related to the possible damage to blood constituents: the TSS_max, for instance, has been associated with hemolysis. It can be expressed as TSS_max=(σ₁−σ₃)/2, σ₁ and σ₃ being the highest and lowest principal normal stresses (PNSs) in each point of the flow.

In the present work, the average value of the shear stress over a spherical surface, representative of a blood component, is derived. All three PNSs (σ₁, σ₂ and σ₃) are found to have an equal role in the determination of this parameter, since the relative formula shows a marked symmetry with respect to the PNSs. The average shear stress level, for a given (σ₁, σ₃) pair (hence, for a given TSS_max), has a minimum and maximum value, depending on the particular σ₂ value yielded by the local structure of the turbulent flow field. A numerical investigation on more complex geometries shows similar results. The role of the intermediate PNS is thus shown for the first time to have a physical relevance. The presented results can be useful whenever a spatial averaging of the shear field is important to be assessed, such as in the case of platelet activation. A new parameter is thus proposed, which can be correlated with prosthetic devices complications.