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A review of the bio-tribology of medical devices

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Friction 2022年第1期10卷 4-30页

作者： Xiaogang ZHANG Yali ZHANG Zhongmin JIN School of Mechanical Engineering Southwest Jiaotong UniversityChengdu 610031China School of Mechanical Engineering Xi'an Jiaotong UniversityXi'an 710049China School of Mechanical Engineering University of Leeds.Leeds LS29JTUK

Numerous medical devices have been applied for the treatment or alleviation of various *** issues widely exist in those medical devices and play vital roles in determining their performance and service *** this review,the bio-tribological issues involved in commonly used medical devices are identified,including artificial joints,fracture fixation devices,skin-related devices,dental restoration devices,cardiovascular devices,and surgical *** current understanding of the bio-tribological behavior and mechanism involved in those devices is *** advances in the improvement of tribological properties are *** and future developments for the prospective of bio-tribological performance are highlighted.

关键词： bio-tribology medical devices wear friction

Bioinspired Functional Surfaces for medical devices

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Chinese Journal of Mechanical Engineering 2022年第3期35卷 37-50页

作者： Liwen Zhang Guang Liu Yurun Guo Yan Wang Deyuan Zhang Huawei Chen School of Mechanical Engineering and Automation Beihang UniversityBeijing 100191China Beijing Advanced Innovation Center for Biomedical Engineering Beihang UniversityBeijing 100191China

medical devices are a major component of precision medicine and play a key role in medical treatment,particularly with the rapid development of minimally invasive surgery and wearable *** tissue contact properties strongly affect device performance and patient health(e.g.,heat coagulation and slipperiness on surgical graspers).However,the design and optimization of these device surfaces are still indistinct and have no supporting *** such conditions,natural surfaces with various unique functions can provide *** review summarizes the current progress in natural functional surfaces for medical devices,including ultra-slipperiness and strong wet *** underlying mechanisms of these surfaces are attributed to their coupling effects and featured micronano *** on various medical requirements,adaptable designs and fabrication methods have been ***,various medical device surfaces have been validated to achieve enhanced contact *** on these studies,a more promising future for medical devices can be achieved for enhanced precision medicine and human health.

关键词： Bioinspired functional surfaces medical devices Wet attachment Interfacial liquid Micro-nano structures Wearable devices

Key considerations on the development of biodegradable biomaterials for clinical translation of medical devices:With cartilage repair products as an example

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Bioactive Materials 2022年第3期7卷 332-342页

作者： Li Wang Xiaolei Guo Jiaqing Chen Zhen Zhen Bin Cao Wenqian Wan Yuandong Dou Haobo Pan Feng Xu Zepu Zhang Jianmei Wang Daisong Li Quanyi Guo Qing Jiang Yanan Du Jiakuo Yu Boon Chin Heng Qianqian Han Zigang Ge Department of Biomedical Engineering College of EngineeringPeking UniversityBeijingPR China Center for medical Device Evaluation National Medical Products AdministrationBeijingPR China Jiangsu DissueTech medical Technology Co.Ltd|DeJian Group SuzhouPR China State Key Laboratory of High Performance Ceramics and Superfine Microstructure Shanghai Institute of CeramicsChinese Academy of SciencesShanghaiPR China Research Center for Human Tissue and Organs Degeneration Shenzhen Institute of Advanced TechnologyChinese Academy of ScienceShenzhenPR China Bioinspired Engineering and Biomechanics Center(BEBC) MOE Key Laboratory of Biomedical Information EngineeringSchool of Life Science and TechnologyXi’an Jiaotong UniversityXi’anPR China Beijing Institute of Science and Technology Evaluation BeijingPR China Institute of Orthopedics Chinese PLA General HospitalBeijingPR China Department of Sports Medicine and Adult Reconstructive Surgery State Key Laboratory of Pharmaceutical BiotechnologyThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolNanjingPR China Department of Biomedical Engineering School of MedicineTsinghua UniversityBeijingPR China Knee Surgery Department of the Institute of Sports Medicine Beijing Key Laboratory of Sports InjuriesPeking University Third HospitalBeijingPR China School of Stomatology Peking UniversityBeijingPR China National Institutes for Food and Drug Control BeijingPR China Department of Biomedical Engineering Institute of Future TechnologyPeking UniversityBeijingPR China

With the interdisciplinary convergence of biology,medicine and materials science,both research and clinical translation of biomaterials are progressing at a rapid ***,there is still a huge gap between applied basic research on biomaterials and their translational products-medical devices,where two significantly different perspectives and mindsets often work independently and non-synergistically,which in turn significantly increases financial costs and research *** this gap is well-known and often criticized in the biopharmaceutical industry,it is gradually *** this article,we critically examine the developmental pipeline of biodegradable biomaterials and biomaterial-based medical device *** based on clinical needs,market analysis,and relevant regulations,some ideas are proposed to integrate the two different mindsets to guide applied basic research and translation of biomaterial-based products,from the material and technical *** repair substitutes are discussed here as an ***,this will lay a strong foundation for biomaterial research and clinical translation,while reducing the amount of extra research effort and funding required due to the dissonance between innovative basic research and commercialization pipeline.

关键词： Biomaterials Polymer Translation medical devices Regulation Clinical needs

medical devices Standardization System in China

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Chinese Journal of Biomedical Engineering(English Edition) 2018年第2期27卷 87-91页

作者： YANG Xiao-fang WANG Chun-ren LI De-yu Beijing University of Aeronautics and Astronautics/School of Biological Science and medical Engineering National Institutes for Food and Drug Control/Center of medical Device

The standardization system is imperfect since the complexity of the medical devices and the specialty of the medical device industry in China. This paper describes the present situation of medical devices standardization system in China,reviews and discusses the advantages and problems of the medical devices standardizatiom. It also presents some comments and suggestions to perfect the medical devices standardization system for enhancing the quality control of medical devices and for promoting the development of medical devices industry.

关键词： medical devices standards

Differences Between Clinical Trials of medical devices and Drugs

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Chinese Journal of Biomedical Engineering(English Edition) 2014年第3期23卷 93-97页

作者： ZHANG Zhi-jun LIU Wei Center of medical Device Evaluation China Food and Drug Administration

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 definition 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 conducting clinical trial design for medical devices.

关键词： medical devices drugs clinical trials differences

medical devices 个人睡眠教练

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科技创业 2010年第1期 23-23页

如果你曾经想知道在一个辗转反侧的晚上,你究竟睡着了多长时间,一款新的家用睡眠质量监测设备可以为你提供答案。使用者在睡觉的时候需要戴一个头箍,头箍上装有负责监控大脑内电流活动情况的传感器。医生使用类似从脑电图里获取的数据来

关键词：教练 medical devices

Experimental Validation of Light Cable-Driven Elbow-Assisting Device L-CADEL Design

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Journal of Bionic Engineering 2022年第2期19卷 416-428页

作者： Med Amine Laribi Marco Ceccarelli Juan Sandoval Matteo Bottin Giulio Rosati Department GMSC Pprime InstituteCNRS-University of Poitiers-ENSMAUPR 334686073 PoitiersFrance Department of Industrial Engineering University of Rome Tor Vergata00133 RomeItaly Department of Industrial Engineering University of Padova35122 PaduaItaly

This paper presents a new design of CADEL,a cable-driven elbow-assisting device,with light weighting and control *** new device design is appropriate to be more portable and user-oriented solution,presenting additional facilities with respect to the original *** of potential benefits of improved portability can be envisaged in the possibility of house and hospital usage keeping social distancing while allowing rehabilitation treatments even during a pandemic *** attention has been devoted to design main mechatronic components by developing specific kinematics *** design process includes an implementation of specific control hardware and *** kinematic model of the new design is formulated and features are evaluated through numerical simulations and experimental *** evaluation from original design highlights the proposed improvements mainly in terms of comfort,portability and user-oriented operation.

关键词： Rehabilitation robotics medical devices Design Simulations Cable-driven parallel robot Control

An overview of functional biolubricants

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Friction 2023年第1期11卷 23-47页

作者： Lumin YANG Xiaoduo ZHAO Zhengfeng MA Shuanhong MA Feng ZHOU State Key Laboratory of Solid Lubrication Lanzhou Institute of Chemical PhysicsChinese Academy of SciencesLanzhou 730000China Center of Materials Science and Optoelectronics Enginering University of Chinese Academy of SciencesBeijing 100049China Yantai Zhongke Research Institute of Advanced Materials and Green Chemical Engineering Yantai 264006China Shandong Laboratory of Yantai Advanced Materials and Green Manufacture Yantai 264006China

At present,more and more diseases are associated with the lubrication dysfunction,which requires a systematic study of the complex lubrication behavior of tissues and organs in human *** biomacromolecular lubricants are essential for maintaining ultra-low coefficients of friction between sliding biological ***,when the surface lubrication performance of tissues or organs destroys heavily,it will bring friction/shear damage for sliding contact ***,the application of exogenous biological lubricating materials to improve the lubrication situation of damaged tissue or organ interfaces has attracted extensive attention of *** this review,based on a simple summary of lubrication mechanism at sliding biological interface,we systematically introduce the research progress of several kinds of representatively biolubrication materials,including eye drops,tissue anti-adhesion agents,joint lubricants,and medical device ***,the lubrication mechanism and individual advantage and shortcoming for each of these synthetic exogenous lubricated materials are ***,the important lubrication application functionality of these biolubricant materials in typically medical surgery scenes,such as dry eye syndrome,tissue adhesion,arthritis,and interventional medical devices,is ***,we look forward to the future development direction of artificial biolubricant materials.

关键词： biolubricants eye drops tissue anti-adhesion arthritis treatment medical devices

Plain metallic biomaterials:opportunities and challenges

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Regenerative Biomaterials 2023年第1期10卷 140-147页

作者： Jiazhen Zhang Bao Zhai Jintao Gao Zheng Li Yufeng Zheng Minglong Ma Yongjun Li Kui Zhang Yajuan Guo Xinli Shi Bin Liu Guobiao Gao Lei Sun Center for medical Device Evaluation National Medical Product AdministrationBeijing 100081China Guangdong-Hong Kong-Macao Greater Bay Area Center for Medical Device Evaluation and Inspection of NMPAShenzhen 518045China School of Materials Science and Engineering Peking UniversityBeijing 100871China State Key Laboratory of Nonferrous Metals and Process GRINM Group Corporation Limited(General Research Institute for Nonferrous Metals)Beijing 100088China

The‘plainification of materials’has been conceptualized to promote the sustainable development of *** perspective,for the first time in the field of biomaterials,proposes and defines‘plain metallic biomaterials(PMBs)’with demonstrated research and application case studies of pure titanium with high strength and toughness,and biodegradable,fine-grained and high-purity ***,after discussing the features,benefits and opportunities of PMBs,the challenges are analyzed from both technical and regulatory *** perspectives on PMB-based medical devices are also provided for the benefit of future research,development and commercialization.

关键词： plainification metallic biomaterials regulatory science medical devices pure titanium high-purity magnesium