中国生物医学工程学报（英文版）杂志

How to design clinical trials for medical devices is a problem plaguing the industry today. As there are many differences in clinical trials of medical devices and drugs. This paper describes the differences of the two points from the perspectivs of defi-nition of medical devices and drugs, scope, phasing, subjects and design of clinical trials in details, aiming to help the related personnel make scientific decisions while conduct-ing clinical trial design for medical devices.

作者： 刊期： 2014年第03期

Biodegradable polymeric nanoparticles are more and more frequently used in drug delivery systems, which represent one of the most rapidly developing areas. In our previous study, a novel natural hybrid polyester, polyethylene glycol 200 (PEG200) end-capped poly (3-hydroxybutyrate-co-3-hydroxyhexanoate) (PHBHHx-PEG) was directly produced by Aeromonas hydrophila fermentation. In this study, the performance of the novel biodegradable PHBHHx-PEG copolyester as a sustained release carrier for hydrophobic drugs with different molecular weights and the in vitro sustained release profile were investigated. 5-Fluorouracil (5-Fu, Mw=130.1), TGX221 (Mw=364.4), and Rapamycin (RAP, Mw=914.2) were used as the model drugs. PHBHHx-PEG nanoparticles entrapped with 5-Fu, TGX221 and RAP were fabricated by a modified emulsification/solvent evaporation method, respectively. The average diameter of 5-Fu, TGX221, and RAP loaded PHBHHx-PEG nanoparticles was between 198.2-217.4 nm, and the entrapment efficiency of the three drugs was 62.5%, 93.4% and 91.9%, respectively. The in vitro release profiles of 5-Fu, TGX221 and RAP from PHBHHx-PEG nanoparticles were different. 5-Fu showed faster release rate and an obvious initial burst release phase. TGX221 and RAP were demonstrated to be released more slowly and steadily. The release percentages of 5-Fu, TGX221 and RAP were 97.7%, 85.1%and 74.7%after releasing for 72 h. PHBHHx-PEG is a kind of promising material as a carrier for the entrapment and delivery of hydrophobic drugs especially for those drugs with high molecular weight.

作者： 刊期： 2014年第02期

作者： 刊期： 2014年第01期

The dielectric properties in vitro present characteristic changes along with the alteration of metabolic activities, which can be detected from tissue micro-structure. The dielectric properties of tissues are closely related to its viability, but the relationship remains unclear to us. This study aims to specify the relationship between dielectric parameters and microstructure of living tissues and to try to explain the influence of tissue viability on dielectric properties. Nine rabbits were studied in this experiment. The impedance spectroscopy (10 Hz-1 MHz) and microstructure were determined at different time intervals (from 5 min to 7 h) after samples were prepared. Some characteristic parameters were extracted to analyze the relationship between them. The inactivation process characterized by the microstructurs could be detected by means of dielectric parameters:the microstructures had no obvious change within 30 min and cell swelling caused by osmosis led to the decrease of extracellular ion concentration, resulting in the rise of lowfrequency imped ance after 30 min. The reduction of impedance was accompanied by the expanding intercellular area and irregular cell shape caused by the gradual destruction of cell membrane.The functions between alteration rate of intercellular area and Cole-Cole model parameters were also established. There is a strong correlative relationship between dielectric properties and microstructure. The dielectric spectrum can be a rapid and innocuous method to monitor the status of tissues. In the future, it may be of great help for clinical application, especially in transplantation.

作者： 刊期： 2014年第02期

To make clear the precise hemodynamic mechanism underlying the anti-atherogenesis benefit of enhanced external couterpulsation(EECP) treatment, and to investigate the proper role of some important hemodynamic factors during the atherosclerotic progress, a comprehensive study combining long-term animal experiment and numerical solving was conducted in this paper. An experimentally induced hypercholesterolemic porcine model was developed and the chronic EECP intervention was subjected. Basic hemodynamic measurement was performed in vivo, as well as the arterial endothelial samples were extracted for physiological examination. Meanwhile, a numerical model was introduced to solve the complex hemodynamic factors such as WSS and OSI. The results show that EECP treatment resulted in significant increase of the instant levels of arterial WSS, blood pressure, and OSI. During EECP treatment, the instant OSI level of the common carotid arteries over cardiac cycles raised to a mean value of 8.58 ×10-2 ±2.13 ×10-2. Meanwhile, the chronic intervention of EECP treatment significantly reduced the atherosclerotic lesions in abdominal aortas and the endothelial cellular adherence. The present study suggests that the unique blood flow pattern induced by EECP treatment and the augmentation of WSS level in cardiac cycles may be the most important hemodynamic mechanism that contribute to its anti-atherogenesis effect. And as one of the indices that cause great concern in current hemodynamic study, OSI may not play a key role during the initiation of atherosclerosis.

作者： 刊期： 2014年第03期

作者： 刊期： 2015年第01期

作者： 刊期： 2014年第01期

The conventional bypass design is to implant a graft on the stenosed host artery allowing blood to flow bypass the stenotic artery. However, restenosis is a challenging problem which finally results in reoperation. The purpose of this paper is to propose a new bypass graft design of coronary artery with an assistant graft for the treatment of coronary artery stenosis. An additional assistant graft was employed in the new design compared with the conventional ETS anastomosis. Numerical simulations were performed by means of finite volume method using computational fluid dynamics (CFD) solver. Results demonstrated that the new anastomoses model provided a more smooth flow at the distal ETS anastomosis without any stagnation point on anastomotic bed and vortex formation in the heel region. Oscillatory shear index (OSI) and time-averaged wall shear stress gradient (TAWSSG) at the artery bed of the distal ETS anastomosis were reduced. The coronary artery bypass graft with an assistant graft is feasible to improve the local hemodynamics and diminish the probability of restenosis in the treatment of coronary artery stenosis.

作者： 刊期： 2014年第01期

作者： 刊期： 2014年第01期

In this paper, an approach to the design of hemispherical breast RF coil array is proposedThe target field method is applied to find the current density distribution on the hemisphere surface, which induces a homogeneous magnetic field in a hemispherical volumeThe components of current density are expanded into Fourier series, and the highly ill-conditioned character of the linear equation related to Fourier coefficients is solved using the Tikhonov regularization method with a minimum curvature penalty functionThe winding pattern was acquired using the stream function techniqueThe results indicate that a simple winding pattern with homogeneous magnetic field can be obtained through manually selecting the penalty factor.

作者： 刊期： 2015年第01期