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新型国产双极射频消融仪应用于离体脊柱标本中的安全性与有效性

Safety and efficacy of a novel domestic bipolar radiofrequency ablation device applied to ex vivo spinal specimens

  • 摘要:
    目的  评估新型国产超高频双极射频消融仪应用于脊柱退变性疾病微创手术的安全性和有效性。
    方法 以6个新鲜尸体脊柱腰椎标本为实验对象,采用新型国产超高频双极射频消融仪进行髓核消融和纤维环烧灼。髓核消融:取L1~L4共18个椎间盘,随机分为6组,经椎间孔侧方将射频电极穿入椎间盘,用50 W、75 W、100 W功率分别消融1 min、2 min,观察髓核消融情况,记录消融范围。纤维环烧灼:取L4~S1共12个椎间盘,按烧灼时间3 s、10 s或15 s随机分为3组,在37℃水浴恒温环境中,分别采用20 W、30 W、40 W功率进行烧灼,通过硬组织切片后HE染色,观察烧灼的深度和周围软组织的碳化情况。
    结果 消融1 min和2 min,髓核在50 W功率下均未见明显气化腔,100 W功率2 min组的消融面积最大(7.471±0.365)mm2, P<0.001。消融前后纤维环4个部位温度升高的程度均小于0.5℃。20 W各时间组烧灼深度显著低于30 W和40 W(P<0.01),但30 W和40 W组间差异无统计学意义;30 W与40 W组内不同烧灼时间组间差异无统计学意义。30 W功率下烧灼3 s即可达到有效烧灼深度。
    结论 新型国产双极射频消融仪在脊柱退变性疾病的髓核消融与纤维环烧灼均能达到良好的临床要求。髓核消融建议100 W消融2 min,纤维环烧灼成形建议30 W烧灼3 s。

     

    Abstract:
    Objective  To evaluate the safety and effectiveness of a new domestic ultra-high frequency bipolar radiofrequency ablation device in minimally invasive surgery for spinal degenerative diseases.
    Methods Using six fresh cadaveric lumbar spine specimens as experimental subjects, 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 randomly divided into six groups. Radiofrequency electrodes were inserted into the intervertebral discs through the lateral aspect of the intervertebral foramen, and ablation was performed at powers 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 time of 3 s, 10 s, or 15 s. In a constant temperature environment of a 37°C water bath, cauterization was performed at powers 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 tissue were observed.
    Results No obvious vaporization cavity was observed in the nucleus pulposus at 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. No significant intra-group differences were found among varying cauterization durations within either the 30 W or 40 W group. An effective cauterization depth was already achieved at 30 W for as short as 3 s.
    Conclusion The new domestic bipolar radiofrequency ablation device can meet good clinical requirements for both nucleus pulposus ablation and annulus fibrosus cauterization in spinal degenerative diseases. For nucleus pulposus ablation, it is recommended to use 100 W for 2 min, while for annulus fibrosus cauterization and shaping, it is recommended to use 30 W for 3 s.

     

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