Research on Development and Clinical Application of a Novel Device for
Hyperthermic Perfusion
LI Jing1, ZHANG Zhen2, CHEN Wenjian1, HUANG Diwen2, CHEN Yanfei1, ZHU Xuejin1, WANG Bin1
1. Department of Urology, Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou Guangdong
510095, China; 2. Guangzhou Bright Medical Technology Co. Ltd., Guangzhou Guangdong 510663, China
Abstract：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.
李靖1，张震2，陈文健1，黄狄文2，陈彦飞1，朱学进1，王斌1. 新型膀胱热灌注治疗仪的研制与临床应用研究[J]. 中国医疗设备, 2023, 38(3): 26-32.
LI Jing1, ZHANG Zhen2, CHEN Wenjian1, HUANG Diwen2, CHEN Yanfei1, ZHU Xuejin1, WANG Bin1. Research on Development and Clinical Application of a Novel Device for
Hyperthermic Perfusion. China Medical Devices, 2023, 38(3): 26-32.
