Ex vivo experiment on the safety and efficacy of a new domestic bipolar radiofrequency ablation generator
10.12025/j.issn.1008-6358.2026.20260205
- VernacularTitle:新型国产双极射频消融仪的安全性和有效性离体实验
- Author:
Yansen HUANG
1
;
Annan HU
1
;
Bing LIANG
2
;
Zizheng WU
3
;
Xiaogang ZHOU
1
Author Information
1. Department of Orthopedics, Zhongshan Hospital, Fudan University, Shanghai 200032, China.
2. Department of Orthopedics, Shanghai Geriatric Medical Center, Shanghai 201104, China.
3. Department of Orthopedics, Shanghai Baoshan District Wusong Central Hospital, Shanghai 200940, China.
- Publication Type:Techniqueandmethod
- Keywords:
spinal degenerative disease;
bipolar radiofrequency ablation;
ex vivo specimen;
efficacy
- From:
Chinese Journal of Clinical Medicine
2026;33(5):880-886
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the safety and efficacy of a new domestic ultra-high frequency bipolar radiofrequency ablation device. Methods Six fresh cadaveric lumbar spine specimens were used as experimental subjects, and a novel domestic ultra-high frequency bipolar radiofrequency ablation device was employed for nucleus pulposus ablation and annulus fibrosus cauterization. Nucleus pulposus ablation: a total of 18 intervertebral discs from L1 to L4 were selected and randomly divided into six groups. Radiofrequency electrodes were inserted into the intervertebral discs through the lateral aspect of the intervertebral foramen, and the ablation was performed at power outputs of 50 W, 75 W, and 100 W for 1 min and 2 min, respectively. The ablation of the nucleus pulposus was observed, and the ablation range was recorded. Annulus fibrosus cauterization: a total of 12 intervertebral discs from L4 to S1 were divided into three groups based on cauterization duration of 3 s, 10 s, or 15 s. In a water bath maintained at a constant 37 °C, cauterization was performed at power outputs of 20 W, 30 W, and 40 W, respectively. After hard tissue sectioning and hematoxylin and eosin (HE) staining, the depth of cauterization and the carbonization of surrounding soft tissues were observed. Results No obvious vaporization cavity was observed in the nucleus pulposus at a power of 50 W for either 1 or 2 min. The 100 W–2 min group achieved the largest ablation area ([7.471±0.365] mm2, P＜0.001). The temperature elevation at all four annulus fibrosus sites remained below 0.5℃ throughout the ablation process. The cauterization depth in the 20 W group was significantly lower than that in both the 30 W and 40 W groups across all time conditions (P＜0.01), whereas no statistically significant difference was observed between the latter two. In 20 W group, the cauterization depth at 3 s was significantly lower than that of the 10 s and 15 s groups (P＜0.01). No significant intra-group differences were found among subgroups with different cauterization durations in the 30 W and 40 W groups. An effective cauterization depth was already achieved at 30 W for 3 s. Conclusions Ex vivo experiments have shown that the new domestic bipolar radiofrequency ablation device possesses excellent ablation efficacy and safety parameters. For nucleus pulposus ablation, it is recommended to use 100 W for 2 min, while for annulus fibrosus cauterization and shaping, 30 W for 3 s is suggested. Its clinical application value remains to be further verified through in vivo studies.
