中国医疗器械杂志最新文献_第6页

[Research on Characterization and Biocompatibility of 3D Printed Ti-6Al-4V Pelvic Prosthesis]. [三维打印 Ti-6Al-4V 骨盆假体的特性和生物相容性研究]。

Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation Pub Date : 2024-05-30 DOI: 10.12455/j.issn.1671-7104.230611

Yuchen Cai, Jiale Guo, Bufang Fu

{"title":"[Research on Characterization and Biocompatibility of 3D Printed Ti-6Al-4V Pelvic Prosthesis].","authors":"Yuchen Cai, Jiale Guo, Bufang Fu","doi":"10.12455/j.issn.1671-7104.230611","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.230611","url":null,"abstract":"The treatment of bone defects caused by fractures or bone tissue lesions has always been a difficult problem in the field of orthopedics. Implantation of high-performance titanium alloy prosthesis is an effective method to treat bone defects. 3D printing technology can produce low-modulus titanium alloy implants with porous structures, providing a better solution to the above problems. This technology is convenient to design and has a huge advantage in making orthopedic implants. The article used electron beam melting in 3D printing technology to create two samples of Ti-6Al-4V prosthesis, including solid structural pelvic prosthesis and porous structural pelvic prosthesis. The mechanical properties of the prosthesis showed that the yield and tensile strengths of the rod tensile specimen were 894 MPa and 956 MPa, respectively, and the compressive modulus and compressive strength of the porous pelvic prosthesis were 55 GPa and 65.2 MPa, respectively. The results of the L929 cytotoxicity assay and the MC3T3-E1 cell adhesion assay demonstrated good biocompatibility of the prosthetic samples. New Zealand white rabbits were used to prepare the femoral joint cavity defect models and two pelvic prostheses were implanted. A microscopic CT scan 4 weeks after implantation showed that the bone defect caused by the drill had healed and that the porous structure of the pelvic prosthesis formed a new trabecular structure within the hole. In conclusion, the 3D printed Ti-6Al-4V pelvic prosthesis has excellent mechanical properties, biocompatibility, and the ability to promote new bone growth.","PeriodicalId":52535,"journal":{"name":"Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141307377","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

[Wireless Pulse Wave Monitoring System Based on Reflective Flexible Probe and AFE4490]. [基于反射式柔性探头和 AFE4490 的无线脉搏波监测系统]。

Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation Pub Date : 2024-05-30 DOI: 10.12455/j.issn.1671-7104.230368

Yan Hang, Lin Huang, Yanan Liu, Haijun Wei, Jilun Ye, Xu Zhang, Chunsheng Liu, Fan Wang

引用次数: 0

[Research Progress of 3D-Printed Polyetheretherketone in Implantable Medical Devices]. [三维打印聚醚醚酮在植入式医疗器械中的研究进展]。

Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation Pub Date : 2024-05-30 DOI: 10.12455/j.issn.1671-7104.230488

Shangda Zhang

引用次数: 0

[Several Aspects Worthy of Attention in the Pre-research of Medical Device Standards]. [医疗器械标准前期研究中值得关注的几个方面]。

Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation Pub Date : 2024-05-30 DOI: 10.12455/j.issn.1671-7104.230333

Yuanyuan Lyu, Liyuan Lu, Li Yi, Qian Dong, Xiaodan Du, Jinglong Tang

引用次数: 0

[Thoughts on High-Quality Innovation and Development of in Vitro Diagnostic Reagents Industry in Shanghai]. [对上海体外诊断试剂产业高质量创新发展的思考]。

Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation Pub Date : 2024-05-30 DOI: 10.12455/j.issn.1671-7104.230465

Shuang Liang, Guomei Sun

引用次数: 0

[Design and Testing of a Pressure Measurement and Adjustment Device for Fracture Ends]. [断端压力测量和调整装置的设计与测试]。

Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation Pub Date : 2024-05-30 DOI: 10.12455/j.issn.1671-7104.230484

Zhongyuan Shen, Yizhe Fan, Xiao Zhang, Zhen Han, Chengjian Wei

{"title":"[Design and Testing of a Pressure Measurement and Adjustment Device for Fracture Ends].","authors":"Zhongyuan Shen, Yizhe Fan, Xiao Zhang, Zhen Han, Chengjian Wei","doi":"10.12455/j.issn.1671-7104.230484","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.230484","url":null,"abstract":"Objective: To design and test a device which is capable of accurately measuring and dynamically adjusting the axial pressure at the fracture end in real-time.Methods: Upon completion of the design, the pressure measurement and adjustment device was implemented in a canine tibial fracture external fixation model. A pressure sensor was mounted at the fracture end, and the displayed values of the pressure sensor were used as the standard for comparison. The relationship between the displayed values of the measurement and adjustment device and the pressure sensor under identical conditions was examined.Results: The device was utilized in external fixation models of tibial fractures in five beagles. A linear correlation was observed between the displayed values of the device and the pressure sensor at the fracture end. The measurement values from the device could be transformed into fracture end pressure through the application of coefficients, thereby facilitating accurate measurement and dynamic adjustment of the fracture end pressure.Conclusion: The pressure measurement and adjustment device at the fracture end is easy to operate, enabling precise measurement and dynamic regulation of the pressure at the fracture end. It is well-suited for animal experiments aimed at investigating the impact of axial compression on fracture healing, demonstrating promising potential for experimental applications.","PeriodicalId":52535,"journal":{"name":"Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141307369","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

[Printing Process Quality Control of Bioprinting Medical Devices]. [生物打印医疗器械的打印过程质量控制]。

Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation Pub Date : 2024-05-30 DOI: 10.12455/j.issn.1671-7104.230394

Neng Xie, Qixin Cao, Jinwu Wang, Yuanjing Xu, Changru Zhang, Ya Wang, Zitong Wang

{"title":"[Printing Process Quality Control of Bioprinting Medical Devices].","authors":"Neng Xie, Qixin Cao, Jinwu Wang, Yuanjing Xu, Changru Zhang, Ya Wang, Zitong Wang","doi":"10.12455/j.issn.1671-7104.230394","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.230394","url":null,"abstract":"Objective: This study analyzes the risk points in the quality control of bioink and the main processes of bioprinting, clarifies and explores the quality control and supervision model for bioprinting medical devices, and provides theoretical and practical guidance to ensure the safety and effectiveness of bioprinting medical devices.Methods: The quality control risk points throughout the bioprinting process were comprehensively analyzed, with a particular focus on bioprinting materials and key processes. The regulatory model and methods for bioprinting medical devices were examined. This research concentrated on critical technologies such as extrusion, laser-assisted, and in situ bioprinting, assessing their potential for clinical applications and regulatory challenges.Results: Bioink from different sources should meet regulatory requirements. It is essential to ensure aseptic handling of raw materials and to validate sterilization under \"worst-case\" conditions.Conclusion: As bioprinting technology advances rapidly, corresponding research into materials, processes, and quality risk control should be conducted to ensure the concurrent development of the regulatory system. This will continuously contribute to the orderly progression of the entire industry and human health.","PeriodicalId":52535,"journal":{"name":"Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141307374","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

[Study on Circulating Tumor Cell Detection System Based on Microfluidic Chip]. [基于微流控芯片的循环肿瘤细胞检测系统研究]。

Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation Pub Date : 2024-05-30 DOI: 10.12455/j.issn.1671-7104.230595

Yuanshuai Di, Ji Luo, Dadi Gao, Haowen Yang

引用次数: 0

[Analysis of Field Inspection Issues and Some Suggestions for Software as Medical Device]. [现场检查问题分析及对软件即医疗器械的一些建议]。

Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation Pub Date : 2024-05-30 DOI: 10.12455/j.issn.1671-7104.230639

Yiqiang Yang, Zhijin Fan, Shuting Guo

引用次数: 0

[Clinical Evaluation of Dural (Spinal) Membrane Repair Materials]. [硬膜（脊柱）膜修复材料的临床评估]。

Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation Pub Date : 2024-05-30 DOI: 10.12455/j.issn.1671-7104.230638

Linling Zhang, Chang Su, Tingting Dong, Kun Zheng

{"title":"[Clinical Evaluation of Dural (Spinal) Membrane Repair Materials].","authors":"Linling Zhang, Chang Su, Tingting Dong, Kun Zheng","doi":"10.12455/j.issn.1671-7104.230638","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.230638","url":null,"abstract":"Objective: To select high-quality and cost-effective dural (spinal) membrane repair materials, in order to reduce the cost of consumables procurement, save medical insurance funds, and optimize hospital operation and management.Methods: Taking the BS06B disease group (spinal cord and spinal canal surgery without extremely severe or severe complications and comorbidities, mainly diagnosed as congenital tethered cord syndrome) as an example, a retrospective analysis was conducted on the relevant data of surgical treatment for congenital tethered cord syndrome conducted in our hospital from January 2021 to June 2023. Safety and efficacy indicators in clinical application (incidence of postoperative epidural hemorrhage, incidence of postoperative purulent cerebrospinal meningitis, incidence of cerebrospinal fluid leakage, surgical duration, and postoperative hospital stay) were compared.Results: There was no difference in safety and effectiveness between different brands of dura mater repair materials.Conclusion: For the repair of small incisions in dura mater surgery, high-quality and cost-effective dura mater repair materials can be selected to reduce hospital costs and control expenses for the disease group.","PeriodicalId":52535,"journal":{"name":"Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141307397","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0