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Regulatory science for hernia mesh: Current status and future perspectives

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Bioactive Materials 2021年第2期6卷 420-432页

作者： Wenbo Liu Yajie Xie Yudong Zheng Wei He Kun Qiao haoye meng School of Material Science and Engineering University of Science and Technology Beijing30 Xueyuan RoadHaidian DistrictBeijingChina Center for Medical Device Evaluation National Medical Products AdministrationIntellectual Property Publishing House MansionQixiang RoadHaidian DistrictBeijingChina

Regulatory science for medical devices aims to develop new tools,standards and approaches to assess the safety,effectiveness,quality and performance of medical *** the field of biomaterials,hernia mesh is a class of implants that have been successfully translated to clinical *** a focus on hernia mesh and its regulatory science system,this paper collected and reviewed information on hernia mesh products and biomaterials in both Chinese and American *** current development of regulatory science for hernia mesh,including its regulations,standards,guidance documents and classification,and the scientific evaluation of its safety and effectiveness was first *** the research prospect of regulatory science for hernia mesh was *** methods for the preclinical animal study and new tools for the evaluation of the safety and effectiveness of hernia mesh,such as computational modeling,big data platform and evidence-based research,were *** taking the regulatory science of hernia mesh as a case study,this review provided a research basis for developing a regulatory science system of implantable medical devices,furthering the systematic evaluation of the safety and effectiveness of medical devices for better regulatory *** was the first article reviewing the regulatory science of hernia mesh and biomaterial-based *** also proposed and explained the concepts of evidence-based regulatory science and technical review for the first time.

关键词： Regulatory science Safety and effectiveness Hernia mesh Regeneration Remolding

A novel bioactive polyurethane with controlled degradation and L-Arg release used as strong adhesive tissue patch for hemostasis and promoting wound healing

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Bioactive Materials 2022年第11期7卷 471-487页

作者： Faxing Zou Yansen Wang Yudong Zheng Yajie Xie Hua Zhang Jishan Chen M.Irfan Hussain haoye meng Jiang Peng School of Material Science&Engineering University of Science and Technology BeijingBeijing10083China The First Affiliated Hospital of Chongqing Medical University China Beijing Key Lab of Regenerative Medicine in Orthopedics Key Laboratory of Musculoskeletal Trauma&War InjuriesPLA Institute of OrthopedicsChinese PLA General HospitalBeijingChina

Effective strategy of hemostasis and promoting angiogenesis are becoming increasingly urgent in modern medicine due to millions of deaths caused by tissue damage and inflammation. The tissue adhesive has been favored as an optimistic and efficient path to stop bleeding, while, current adhesive presents limitations on wound care or potential degradation safety in clinical practice. Therefore, it is of great clinical significance to construct multifunctional wound adhesive to address the issues. Based on pro-angiogenic property of L-Arginine (L-Arg), in this study, the novel tissue adhesive (G-DLPUs) constructed by L-Arg-based degradable polyurethane (DLPU) and GelMA were prepared for wound care. After systematic characterization, we found that the G-DLPUs were endowed with excellent capability in shape-adaptive adhesion. Moreover, the L-Arg released and the generation of NO during degradation were verified which would enhance wound healing. Following the in vivo biocompatibility was verified, the hemostatic effect of the damaged organ was tested using a rat liver hemor-rhage model, from which reveals that the G-DLPUs can reduce liver bleeding by nearly 75% and no obvious inflammatory cells observed around the tissue. Moreover, the wound care effect was confirmed in a mouse full-thickness skin defect model, showing that the hydrogel adhesive significantly improves the thickness of newly formed dermis and enhance vascularization (CD31 staining). In summary, the G-DLPUs are promising candidate to act as multifunctional wound care adhesive for both damaged organ and trauma.

关键词： Tissue adhesive Pro-angiogenic Biodegradable safety Arginine-based polyurethane Hemostasis

Acellular nerve xenografts based on supercritical extraction technology for repairing long-distance sciatic nerve defects in rats

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Bioactive Materials 2022年第12期7卷 300-320页

作者： Shuai Wei Qian Hu Jianxiong Ma Xiu Dai Yu Sun Gonghai Han haoye meng Wenjing Xu Lei Zhang Xinlong Ma Jiang Peng Yu Wang Tianjin Hospital Tianjin UniversityNo.406 Jiefang South RoadHexi DistrictTianjin300211China Institute of Orthopedics The First Medical CenterChinese PLA General HospitalBeijing Key Lab of Regenerative Medicine in OrthopedicsKey Laboratory of Musculoskeletal Trauma and War Injuries PLANo.28 Fuxing RoadHaidian DistrictBeijing 100853China Key Laboratory of Neuroregeneration of Jiangsu and Ministry of Education Neural Regeneration Co-Innovation Center of Jiangsu ProvinceNantong UniversityNo.19 Qixiu RoadChongchuan DistrictNantong226001China Department of Geriatrics The Second People’s Hospital of NantongAffiliated Rehabilitation Hospital of Nantong UniversityNo.298 Xinhua RoadChongchuan DistrictNantong226006China Institute of Orthopedics Tianjin Hospital Tianjin UniversityTianjin Key Laboratory of Orthopedic Biomechanics and Medical EngineeringNo.155 Munan RoadHeping DistrictTianjin300050China The First People’s Hospital of Yunnan Province No.157 Jinbi RoadXishan DistrictKunming650034China Academy of Medical Engineering and Translational Medicine Tianjin UniversityNo.92 Weijin RoadNankai DistrictTianjin300072China

Compared to conventional artificial nerve guide conduits (NGCs) prepared using natural polymers or synthetic polymers, acellular nerve grafts (ACNGs) derived from natural nerves with eliminated immune components have natural bionic advantages in composition and structure that polymer materials do not have. To further optimize the repair effect of ACNGs, in this study, we used a composite technology based on supercritical carbon dioxide (scCO_(2)) extraction to process the peripheral nerve of a large mammal, the Yorkshire pig, and obtained an innovative Acellular nerve xenografts (ANXs, namely, CD + scCO_(2) NG). After scCO_(2) extraction, the fat and DNA content in CD + scCO_(2) NG has been removed to the greatest extent, which can better supported cell adhesion and proliferation, inducing an extremely weak inflammatory response. Interestingly, the protein in the CD + scCO_(2) NG was primarily involved in signaling pathways related to axon guidance. Moreover, compared with the pure chemical decellularized nerve graft (CD NG), the DRG axons grew naturally on the CD + scCO_(2) NG membrane and extended long distances. In vivo studies further revealed that the regenerated nerve axons had basically crossed the CD + scCO_(2) NG 3 weeks after surgery. 12 weeks after surgery, CD + scCO_(2) NG was similar to autologous nerves in improving the quality of nerve regeneration, target muscle morphology and motor function recovery and was significantly better than hollow NGCs and CD NG. Therefore, we believe that the fully decellularized and fat-free porcine ACNGs may be the most promising “bridge” for repairing human nerve defects at this stage and for some time to come.

关键词： Peripheral nerve regeneration Acellular nerve xenograft Supercritical extraction Peripheral nerve injury Nerve defect

Polylysine-decorated macroporous microcarriers laden with adipose-derived stem cells promote nerve regeneration in vivo

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Bioactive Materials 2021年第11期6卷 3987-3998页

作者： Yi Sun Xiaoqi Chi haoye meng mengjiao Ma Jing Wang Zhaoxuan Feng Qi Quan Guodong Liu Yansen Wang Yajie Xie Yudong Zheng Jiang Peng School of Materials Science and Engineering University of Science and Technology BeijingBeijing100083PR China Institute of Orthopedics Chinese PLA General HospitalBeijing Key Lab of Regenerative Medicine in OrthopedicsKey Lab of Musculoskeletal Trauma&War InjuriesPLANo.28 Fuxing RoadBeijing100853PR China Qingdao National Laboratory for Marine Science and Technology Qingdao266237PR China Co-innovation Center of Neuroregeneration Nantong UniversityNantongJiangsu Province226007PR China

Cell transplantation is an effective strategy to improve the repair effect of nerve guide conduits(NGCs).However,problems such as low loading efficiency and cell anoikis undermine the *** are efficient 3D cell culture scaffolds,which can also prevent cell anoikis by providing substrate for adhesion during ***,we demonstrate for the first time microcarrier-based cell transplantation in peripheral nerve *** first prepared macroporous chitosan microcarriers(CSMCs)by the emulsion-phase separation method,and then decorated the CSMCs with polylysine(pl-CSMCs)to improve cell *** then loaded the pl-CSMCs with adipose-derived stem cells(ADSCs)and injected them into electrospun polycaprolactone/chitosan NGCs to repair rat sciatic nerve *** ADSCs-laden pl-CSMCs effectively improved nerve regeneration as demonstrated by evaluation of histology,motor function recovery,electrophysiology,and gastrocnemius *** efficient cell transplantation,convenient operation,and the multiple merits of ADSCs,the ADSCs-laden pl-CSMCs hold good potential in peripheral nerve repair.

关键词： Chitosan microcarriers Polylysine Adipose-derived stem cells Peripheral nerve repair Cell transplantation

Dual-bionic regenerative microenvironment for peripheral nerve repair

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Bioactive Materials 2023年第8期26卷 370-386页

作者： Yanjun Guan Zhiqi Ren Boyao Yang Wenjing Xu Wenjun Wu Xiangling Li Tieyuan Zhang Dongdong Li Shengfeng Chen Jun Bai Xiangyu Song Zhibo Jia Xing Xiong Songlin He Chaochao Li Fanqi meng Tong Wu Jian Zhang Xiuzhi Liu haoye meng Jiang Peng Yu Wang Institute of Orthopedics The Fourth Medical Center of Chinese PLA General HospitalBeijing Key Lab of Regenerative Medicine in OrthopedicsKey Laboratory of Musculoskeletal Trauma&War Injuries PLANo.51 Fucheng RoadBeijing100048PR China Co-innovation Center of Neuroregeneration Nantong University NantongJiangsu Province226007PR China Graduate School of Chinese PLA General Hospital No.28 Fuxing RoadBeijing100853PR China Hebei North University Zhangjiakou075051PR China School of Medicine Nankai UniversityTianjin300071PR China

Autologous nerve grafting serves is considered the gold standard treatment for peripheral nerve defects;however,limited availability and donor area destruction restrict its widespread clinical *** the performance of allogeneic decellularized nerve implants has been explored,challenges such as insufficient human donors have been a major drawback to its clinical ***-engineered neural regeneration materials have been developed over the years,and researchers have explored strategies to mimic the peripheral neural microenvironment during the design of nerve catheter grafts,namely the extracellular matrix(ECM),which includes mechanical,physical,and biochemical signals that support nerve *** this study,polycaprolactone/silk fibroin(PCL/SF)-aligned electrospun material was modified with ECM derived from human umbilical cord mesenchymal stem cells(hUMSCs),and a dual-bionic nerve regeneration material was successfully *** results indicated that the developed biomimetic material had excellent biological properties,providing sufficient anchorage for Schwann cells and subsequent axon regeneration and angiogenesis ***,the dual-bionic material exerted a similar effect to that of autologous nerve transplantation in bridging peripheral nerve defects in *** conclusion,this study provides a new concept for designing neural regeneration materials,and the prepared dual-bionic repair materials have excellent auxiliary regenerative ability and further preclinical testing is warranted to evaluate its clinical application potential.

关键词： Electrospun Umbilical cord mesenchymal stem cells Extracellular matrix Peripheral nerve regeneration Tissue engineering

Descriptor-augmented machine learning for enzyme-chemical interaction predictions

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Synthetic and Systems Biotechnology 2024年第2期9卷 259-268页

作者： Yilei Han haoye Zhang Zheni Zeng Zhiyuan Liu Diannan Lu Zheng Liu Department of Chemical Engineering Tsinghua UniversityBeijing100084China Department of Computer Science and Technology Tsinghua UniversityBeijing100084China

Descriptors play a pivotal role in enzyme design for the greener synthesis of biochemicals,as they could characterize enzymes and chemicals from the physicochemical and evolutionary *** study examined the effects of various descriptors on the performance of Random Forest model used for enzyme-chemical relationships *** curated activity data of seven specific enzyme families from the literature and developed the pipeline for evaluation the machine learning model performance using 10-fold *** influence of protein and chemical descriptors was assessed in three scenarios,which were predicting the activity of unknown relations between known enzymes and known chemicals(new relationship evaluation),predicting the activity of novel enzymes on known chemicals(new enzyme evaluation),and predicting the activity of new chemicals on known enzymes(new chemical evaluation).The results showed that protein descriptors significantly enhanced the classification performance of model on new enzyme evaluation in three out of the seven datasets with the greatest number of enzymes,whereas chemical descriptors appear no effect.A variety of sequence-based and structure-based protein descriptors were constructed,among which the esm-2 descriptor achieved the best *** enzyme families as labels showed that descriptors could cluster proteins well,which could explain the contributions of descriptors to the machine learning *** a counterpart,in the new chemical evaluation,chemical descriptors made significant improvement in four out of the seven datasets,while protein descriptors appear no *** attempted to evaluate the generalization ability of the model by correlating the statistics of the datasets with the performance of the *** results showed that datasets with higher sequence similarity were more likely to get better results in the new enzyme evaluation and datasets with more enzymes were more likely beneficial from the protein

关键词： Enzyme-substrate interaction Enzyme design Machine learning Descriptor

复合多孔水凝胶的微观结构与数字散斑相关分析

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复合材料学报 2011年第1期28卷 50-55页

作者：孟昊业郑裕东奚廷斐姚学锋吕鹤翔徐曼琼北京科技大学材料科学与工程学院北京100083 清华大学工程力学所北京100084

研究了不同多孔结构聚乙烯醇水凝胶的微观形貌,采用数字散斑相关技术和力学实验测试等对多孔水凝胶在受力状态下的微区位移、压缩模量及泊松比进行分析和计算。研究发现,多孔水凝胶的孔隙率和孔径大小对形变等位移线分布有明显影响。随... 详细信息

研究了不同多孔结构聚乙烯醇水凝胶的微观形貌,采用数字散斑相关技术和力学实验测试等对多孔水凝胶在受力状态下的微区位移、压缩模量及泊松比进行分析和计算。研究发现,多孔水凝胶的孔隙率和孔径大小对形变等位移线分布有明显影响。随着致孔剂含量的增加,多孔水凝胶的等位移线由均匀分布的近似平行线变为不均匀的S形曲线,出现等位移线密度明显增大的应力集中区域。多孔水凝胶孔隙率增加,形变增大。致孔剂种类及含量不同时,水凝胶的泊松比值随着载荷的增加逐渐减小,致孔剂含量越多泊松比值越小,压缩模量则随着应变的增加逐渐增大。

关键词：复合水凝胶多孔结构力学性能微观形变

多孔PVA水凝胶的组成、形貌及泊松比等力学性能研究

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高分子学报 2009年第11期19卷 1096-1100页

作者：吕鹤翔郑裕东孟昊业徐曼琼郭兴敏北京科技大学材料科学与工程学院北京100083 清华大学航空航天学院北京100084

制备了不同含量的纯聚乙烯醇(PVA)水凝胶和不同表面活性剂含量的多孔PVA水凝胶,采用数字散斑测量其泊松比,并使用电镜和显微镜观察其微观结构,探讨了纯PVA水凝胶与多孔PVA水凝胶组成、微观结构、泊松比、压缩模量和体积模量的变化及相... 详细信息

制备了不同含量的纯聚乙烯醇(PVA)水凝胶和不同表面活性剂含量的多孔PVA水凝胶,采用数字散斑测量其泊松比,并使用电镜和显微镜观察其微观结构,探讨了纯PVA水凝胶与多孔PVA水凝胶组成、微观结构、泊松比、压缩模量和体积模量的变化及相互关系.研究发现,采用表面活性剂成孔,反复冷冻成型制备的闭孔结构水凝胶,其泊松比随应力应变增加而减小;随PVA含量增加而泊松比值减小;随表面活性剂含量增加,孔径变大,泊松比值减小.PVA水凝胶泊松比值与压缩模量和体积模量的比值成正比.

关键词：泊松比多孔水凝胶聚乙烯醇表面活性剂

Effects of tissue heterogeneity on trabecular micromechanics examined by microCT-based finite element analysis and digital volume correlation

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Medicine in Novel Technology and Devices 2021年第3期11卷 217-225页

作者： Jizhi Fu haoye meng Changhao Zhang Youjun Liu Duanduan Chen Aiyuan Wang Russell P.Main Haisheng Yang Department of Biomedical Engineering Faculty of Environment and LifeBeijing University of TechnologyBeijingChina Institute of Orthopedics Chinese PLA General HospitalBeijingChina School of Life Science Beijing Institute of TechnologyBeijingChina Musculoskeletal Biology and Mechanics Lab Department of Basic Medical SciencesPurdue UniversityINUSA Weldon School of Biomedical Engineering Purdue UniversityINUSA

Trabecular bone is natural material with heterogeneous tissue *** effect of tissue heterogeneity on the micromechanical behavior of trabecular bone is commonly evaluated by microCT-based finite element(microFE)*** from prior work remain inconclusive and lack of experimental *** address these issues,we combined microFE analysis with mechanical testing and microCT-based digital volume correlation(DVC),as a validation for the microFE *** trabecular specimens were tested in compression as sequential microCT scans were *** was performed to extract“realistic”boundary conditions that were applied to microFE models,and to measure microstructural deformation and strain of the trabecular *** and homogeneous microFE models of each trabecular specimen were created and compared with the experimentally measured microstructural displacement and *** showed strong correlations between DVC-measured and microFE-predicted trabecular displacement and strain fields(R^(2)>0.9,p<0.05),regardless of heterogeneous or homogeneous material *** heterogeneous and homogeneous models predicted similar magnitudes for maximum or minimum principal strains(R^(2)=1,p<0.05).However,incorporation of tissue heterogeneity decreased more than 16.5%in the overall stress level of the trabecular ***,very strong correlations were found between the heterogeneous and homogeneous model-predicted principal strains or *** results together suggest that tissue heterogeneity may have little effect on microFE modeling of typical elastic displacement and strains in the trabecular bone,suggesting that homogeneous material models might be sufficient to predict general trabecular micromechanics.

关键词： Trabecular bone Tissue heterogeneity Finite element analysis microCT Digital volume correlation