舱体支撑行走式X射线防护服设计创新研发实践

Innovative Design and Development of Cabin-Supported Walking X-Ray Protective Clothing

导管室介入手术医生临床常用防护服超负重、防护不全面,导致慢性损伤的行业痛点。笔者及团队通过全面调研X射线防护服产品市场、产业环境、竞品情况、实地作业环境、作业动作,以及防护服的着装生理和心理需求,采用“行走器”支撑“包裹铅衣”形成防护舱的创新构思,研制了一款新型的“舱体支撑式X射线防护服”,对人体实施射线隔离防护,该产品经医疗器械检验符合医药行业标准YY 0318-2000《医用诊断X射线辐射防护器具第3部分:防护服和性腺防护器具》检测,并进行临床仿真实验及灵活性、准确性对比实验测试,研究结果表明:舱体支撑行走式X射线防护服产品质量符合国家医用诊断X射线个人防护材料及用品要求,着装者无须承重,作业动作自如,移动行走灵活,视野清晰开阔,穿戴方便快捷。

The commonly used clinical protective clothing for the catheter room by interventional surgery doctors is overweight,inadequate protection,resulting in chronic injury.To master the physiological and psychological requirements of protective clothing,the market,the industry environment and competition of X-ray protective clothing is investigated,the operating environment of interventional surgeon is observed,and the operating action is analyzed.“Cabin supporting walker”and“Wrapped lead apron”are both innovatively used to protect human body,the design conception of the protective cabin is adopted.A cabin supporting type X-ray protective clothing is designed and developed.The cabin supporting type X-ray protective clothing is recorded by the State Food and Drug Administration,and tested by the Medical Device Inspection Department according to the medical industry standard YY 0318-2000 medical diagnostic X-ray radiation protective devices part 3:protective clothing and gonadal protective devices.The clinical simulation experiment and the flexibility,the accuracy contrast experiment tests are carried on.The results show that the product quality of the cabin support walking X-ray protective clothing meets the requirements of the national medical diagnostic X-ray personal protective mate.