新型膀胱热灌注治疗仪的研制与临床应用研究

Research on Development and Clinical Application of a Novel Device for Hyperthermic Perfusion

目的为满足临床上对于膀胱热灌注设备的需求,设计并制造一款新型膀胱热灌注治疗仪。方法采用热传导化疗技术,新型膀胱热灌注治疗仪通过体外电磁加热的方式,配合一次性避光管道、升降装置、闭环设计及自动化控制软件来完成膀胱的循环灌注治疗,前瞻性纳入非肌层浸润性膀胱癌(Non-Muscle Invasive Bladder Cancer,NMIBC)患者32例,共完成136次膀胱热灌注化疗(Hyperthermic Intravesical Chemotherapy,HIVEC),探究新型膀胱热灌注治疗仪各项性能。结果中危NMIBC患者的1年无复发生存率为78.9%,1年无进展生存率为94.1%;高危NMIBC患者的1年无复发生存率为66.6%,未见肿瘤进展,采用新型膀胱热灌注治疗仪进行HIVEC未发现3级及以上的不良事件,以及因设备本身故障而导致的灌注失败,各项性能完全达到临床设计要求。结论新型膀胱热灌注治疗仪能更好地满足临床需求,提高药物浓度及加热效率,实时尿量监测,保持膀胱适度充盈,安全性高。

Objective To design and develop a novel device for hyperthermic perfusion to facilitate the clinical work and perform a pilot study.Methods With the technology of conductive hyperthermic chemotherapy,the novel device adopted electromagnetic heating mode,combined with disposable light-proof pipe,lifting device,closed-loop design and automatic software to complete the circulation of bladder perfusion treatment.32 patients with non-muscle invasive bladder cancer(NMIBC)were prospectively enrolled,and a total of 136 treatments of hyperthermic intravesical chemotherapy(HIVEC)had been performed to explore the performance of a novel device HIVEC.Results The 1-year recurrence free survival and 1-year progression free survival rate were 78.9%and 94.1%for intermediate risk group,and the 1-year recurrence-free survival rate of high-risk NMIBC patients was 66.6%,and no tumor progression was observed.Adverse event of grade 3 or above was not observed in HIVEC performed by this novel device.There was no perfusion failure caused by the problem of the equipment itself.The performance of the product could fully meet the requirements of clinical design.Conclusion This novel device for HIVEC could satisfy the clinical needs and improve drug concentration and heating efficiency.It can monitor urine volume in real time to keep the bladder moderately full and safe.