摘要
目的设计婴幼儿髋关节持续被动运动(Continuous Passive Motion,CPM)小儿骨科设备,并分析本设备对发育性髋关节发育不良(Developmental Dysplasia of the Hip,DDH)的治疗作用。方法本设备由主机与活动支架构成。主机实现人机交互,调控外部输入的高压气体。活动支架是全新的动态蛙式外展支架,在高压气体驱动下带动婴幼儿髋关节完成CPM。设备性能参数符合设计目标。在取得医疗器械注册证后,对29例(41髋)患儿进行CPM治疗,比较治疗前后髋臼指数与髂骨角的数值。结果临床治疗2个月后,患儿髋臼指数从34.5±1.0下降至30.1±1.0,髂骨角从(50.2±1.2)°上升至(52.4±1.3)°,差异均具有显著统计学意义(P<0.01)。结论本设备适用于婴幼儿,对婴幼儿DDH具有积极的治疗效果,为婴幼儿DDH的治疗提供了一种新思路。
Objective To design a device for continuous passive motion(CPM)of the hip joint in infants,and to analyze the therapeutic effect on the developmental dysplasia of the hip(DDH).Methods The device consisted of a host and a movable bracket.The host completed human-computer interaction and regulated the high-pressure gas input from the outside.The movable stent was a new dynamic frog abduction stent,which is driven by high-pressure gas leading the joint of infants to complete CPM.The performance parameters of the device met the design goals.After obtaining the medical device registration certificate,29 children(41 hips)were treated with CPM,and the acetabular index and the iliac angle were compared before and after the treatment.Results After 2 months of clinical treatment,the acetabular index was decreased from 34.5±1.0 to 30.1±1.0,and the iliac angle was raised from(50.2±1.2)°to(52.4±1.3)°.The differences were statistically significant(P<0.01).Conclusion The device is suitable for infants,and it has a positive therapeutic effect on infant DDH.Also,it provides a new idea for the treatment of infant DDH.
作者
陈彪
胡大勇
王晶晶
梁振
CHEN Biao;HU Dayong;WANG Jingjing;LIANG Zhen(School of Biomedical Engineering,Anhui Medical University,Hefei Anhui 230032,China;Department of Pediatric Orthopedics,Southeast Surgery Hospital of Hefei,Hefei Anhui 230001,China;Hefei Huijia Medical Technology Co.,Ltd.,Hefei Anhui 230001,China)
出处
《中国医疗设备》
2021年第6期35-39,58,共6页
China Medical Devices
基金
国家自然科学基金(31400943)
国家重点研发计划(2017YFC0108801)
安徽省转化医学研究院科研基金项目(2017zhyx28)。
关键词
发育性髋关节发育不良
持续被动运动
微控制器
髋关节
developmental dysplasia of the hip
continuous passive movement
microcontroller
the hip joint
