Development and Initial Testing of a Permanently Implantable Centrifugal Pump

Abstract: To be able to salvage heart failure patients, the need for an economical permanent ventricular assist device is increasing. To meet this increasing demand, a miniaturized centrifugal blood pump has been developed as a permanently implantable device. The Gyro permanently implantable model (PI-601) incorporates a sealless design with a blood stagnation free structure. The pump impeller is magnetically coupled to the driver magnet in a sealless manner. This pump is atraumatic and antithrombogenic and incorporates a double pivot bearing system. A miniaturized actuator was utilized in this system in collaboration with the University of Vienna. The priming volume of this pump is 20 ml. The overall size of the pump actuator package is 53 mm in height and 65 mm in diameter, 145 ml of displacement volume, and 305 g in weight. Testing to date has included in vitro hydraulic performance and hemolysis. This pump can provide 5 L/min against a 110 mm Hg total pressure head at 2,000 rpm and 8 Limin against 150 mm Hg at 2,500 rpm. The normalized index of hemo-lysis (NIH) value of this pump was 0.0028 g/100 L at 5 Limin against 100 mm Hg. A preliminary anatomical study revealed the possibility of the implantability of 2 such systems in biventricular bypass at a preperitoneal location. This system is feasible for use as a permanently implantable biventricular assist device.     

Experimental Assessment of Right Ventricular Function in Normal Pigs with a Left Ventricular Assist Device

Abstract: Right ventricular (RV) failure during the use of a left ventricular assist device (LVAD) is the leading cause of death in circulatory support patients. Previous work, both experimentally and clinically, has shown the difficulties in predicting the behavior of the right ventricle at the start of LVAD. An experimental study has been designed to evaluate RV functional changes during LVAD and its relation to preload changes. The model used adult mongrel pigs (n = 10). Right ventricular functional parameters were measured with a thermodilution RV ejection fraction catheter. The left ventricle was supported by a Nippon Zeon blood pump. Two groups were studied, the first one was the LVAD–off group (n = 5) and the other was the LVAD–on group (n = 5) which was supported by LVAD at maximum flow. Change of cardiac output, mean pulmonary artery pressure (PAP), RV stroke work, and RV ejection fraction in both groups were not significantly different. However, the relationship between right ventricular end–diastolic pressure (RV–EDP) and right ventricular stroke volume (RVSV) was significantly changed at a high level of RV–EDP. When RV–EDP was over 6. 5 mm Hg in the LVAD–off group, RVSV decreased to 52. 3 ± 11. 5 ml while in the LVAD–on group, RVSV increased to 97. 2 ± 22. 0 ml. The change in PAP in the LVAD–on group was lower than in the LVAD–off group. We conclude that, at the volume overload state, LVAD can reduce the afterload of the right ventricle and maintain Frank–Starling's effect, thus having a beneficial effect on right ventricular performance.     

医疗器械产品召回制度探讨与典型案例分析

着重介绍了国内外医疗器械产品召回制度现状,并以强生血糖仪、佳腾除颤器两起召回事件为案例,阐明整个召回事件处理的过程,旨在为我国建立和完善医疗器械产品召回制度提供借鉴。     

Controlled release of sugar and toxicant from a novel device for controlling pest insects

A novel biodegradable device, designed for long-lasting residual effectiveness of feeding stimulant (sugar) and insecticide (dimethoate) against apple maggot flies and other insects, was formulated. The device is an 8-cm diameter fruit-mimicking sphere, consisting of 42–50% sugar entrapped in a mixture of gelatinized corn flour and wheat flour in the presence of glycerin, and coated with a layer of latex paint containing dimethoate and sugar. We found that the outer layer of paint prevents cracking of the sphere upon drying and creates a barrier to control the release of both sugar and dimethoate. Releases of each ingredient were screened first by chemical analysis and then by bioassays in the laboratory and in field cages against apple maggot flies. Chemical analysis demonstrated strong potential for controlled release of water-soluble feeding stimulant and water-insoluble insecticide measured as a function of the amount of rainfall and duration of exposure time. Field results showed greater than 70% insecticidal activity after 11 weeks of sphere exposure in an orchard. This device has the potential to be used for a variety of insect-control applications through manipulating its shape, color and texture into forms known to be attractive to target insects, and by employing various toxicants designed to be effective against such insects.     

表面改性在介入器械上的应用

论述赋予介入器械的材料表面润滑性、抗菌性、抗凝血性及抗组织增生等性能的各种表面改性技术的现状，讨论这些技术的一些应用的实例，提出需要进一步研究的问题。     

Use of a Paracorporeal Pneumatic Ventricular Assist Device for Postoperative Cardiogenic Shock in Two Children with Complex Cardiac Lesions

Pneumatic ventricular assist device (VAD) was utilized for cardiogenic shock after intracardiac operation in two children with complex cardiac anomalies based with single ventricle. In the first case (a 10-year-old), after a modified Fontan operation, VAD was placed between the functional left atrium and ascending aorta, serving as a "artificial single ventricle" with neither pumping chamber nor artificial support in the right side of the heart. The systemic circulation was maintained by keeping relatively high central venous pressure. In another child (a 3-year-old) who underwent repair of incompetent atrioventricular valve leaving intracardiac lesions, VAD was placed between the common atrium and ascending aorta, serving as a pump for both pulmonary and systemic circulation with regulation of pulmonary blood flow through an aortopulmonary Gore-Tex shunt. The circulatory assist with VAD was utilized for 5 and 6 days, respectively. Although weaning from the device was not feasible in both patients because of the pulmonary dysfunction, these experience showed the possible use of VAD for cardiogenic shock after surgery in patients with complex cardiac anomalies.     

头颈部肿瘤射野摆位误差的差异性研究

目的：研究采用电子射野系统评价头颈部肿瘤患者摆位误差时的观察者间变异和观察者自身变异。方法：两队研究小组，分别由四名医师和四名技师组成，两组分别对6名头颈部肿瘤的患者，采用电子射野影像仪（electronic portal imaging device，EPID）拍摄验证片（electronic portal images，EPIs），在EPIs上勾画骨性标志，以放疗计划生成的数字重建图像（digitally reconstructed radiographs，DRRs）做为参考图像，定量分析不同观察研究人员之间和研究人员自身采用EPID确定头颈部肿瘤患者的射野摆位误差（field placement errors，FPEs）的差异性。结果：在前／后位射野图像上．不同医师之间、医师自身及技师自身对摆位误差的判断无明显差异，但在技师之间出现了明显的自身差异性．医师组和技师组在前／后射野图像上的均方根（root-mean—square，RMS）分别为2．52±0．46和3．43±0．43，两者具有明显差异；在侧位野图像上，医师自身对摆位误差的判断有较好的稳定性，但部分不同医师之间在腹背、头足方向上部分患者中出现差异，而不同的技师之间存在明显差异性，医师组和技师组在侧位射野图像上的RMS分别为2．72±0．16和2．62±0．22．两者无明显差异。结论：医师和技师组在采用电子射野系统对头颈部摆位误差进行判断时存在人员之间的误差，应对所有人员进行统一训练才能减少射野摆位误差，从而提高IMRT治疗效果。     

双凤尾钢板植骨内固定治疗胸腰椎爆裂骨折的生物力学测试

目的 对双凤尾钢板治疗胸腰椎爆裂骨折进行生物力学评价和临床应用观察。方法 取成年男性尸体脊柱标本(T12-L2),制成8具L1椎体爆裂骨折模型。按实际手术方法放置双凤尾钢板。对试件分别进行轴向和弯曲扭转加载测试。临床观察应用双凤尾钢板治疗胸腰椎爆裂骨折的效果。结果 压缩实验和弯曲扭转实验中,各点应变值与载荷均呈线性关系。当轴向载荷达到600N或扭矩达到600N·cm时,这种线性关系未改变。弯扭矩与模型两端之间相对扭转角的增加呈线性关系。弯扭矩达到600N·cm时,扭转角只有6.26°。临床观察表明双凤尾钢板固定可靠。结论 双凤尾钢板固定具有良好的稳定性,表现出高弹性,符合生物学固定的原则。值得临床推广应用。     

The fourth-generation centrifugal blood pump

 The NEDO Gyro permanently implantable (PI) centrifugal blood pump has been developed as a simple, durable, centrifugal blood pump without a complex magnetic suspension system. In vitro studies were performed using a Gyro PI pump with the transparent pump housing in a mock circuit. These studies revealed that the impeller transfers to a floating or a top contact condition, which was dependent on the revolutions per minute (RPM). This pump can be easily converted from a left ventricular assist device (LVAD) to a right ventricular assist device (RVAD) by simply adding a spacer between the pump and the actuator. In order to optimize the impeller suspension for the LVAD and RVAD, spacers of the proper thickness are inserted between both of the pumps and the actuators to regulate the magnetic force. Two Gyro PI pumps were implanted in a bovine model in a 3-month biventricular assist device (BVAD) animal study. This experiment was electively terminated 90 days after implantation. All of the parameters, including pump flow rate, power consumption, and plasma free hemoglobin, were in acceptable ranges. No thrombus formation was observed in either pump. Antithrombogenesis and effectiveness were demonstrated in this animal study. The NEDO Gyro PI pump is ready to move on to the 3-month preclinical system evaluation. Received: February 28, 2002 / Accepted: May 30, 2002 Acknowledgment The New Energy and Industrial Technology Development Organization (NEDO) under the Ministry of Economy, Trade and Industry of Japan financially supported this project. Correspondence to:S. Ichikawa     

锥板式粘度计测定低切血液粘度方法的实验研究

我们用锥板式粘度计从低切到高切、从高切到低切、以及先在８０ｓ－１下旋转６０ｓ、静止１００ｓ、再从低切到高切三种方法，测定了Ｖｉｓｔｅｒ大白鼠在低切变率为５．７５－１时的血液粘度。组间对照显示，三种测法所得低切血液粘度之间无显著差异，表明这些方法均可用来测量低切血液粘度。从低切稳定性来看，第二种测法最好。就用粘度法反映红细胞聚集性而言，第一种测法比较合适。