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新型经皮可控弯等离子髓核消融针的有效性和安全性离体分析

The effectiveness and safety of a percutaneous controllable curved plasma radiofrequency ablation device of nucleus pulposus

  • 摘要:
    目的 验证一种新型经皮可控弯等离子髓核消融针的安全性及有效性。
    方法 设计一种新型经皮可控弯等离子髓核消融针(可控弯组),应用大体标本对比其与目前临床上常用的直头不可弯等离子髓核消融针(不可弯组)的消融效果。消融针均经右侧椎间孔置入,对同一节段椎间盘连续消融3次,记录其消融范围、消融轨迹,并通过置入的测温探针监测椎间盘内消融中心前、后、左(穿刺对侧)、右(穿刺侧)侧在消融过程中及消融后15 s的温度变化。
    结果 消融过程中、消融后15 s,两组消融中心前、后,右侧区域温度变化差异无统计学意义;可控弯组第3次消融过程中、消融后15 s消融中心左侧温度变化大于不可弯组(P<0.01)。与不可弯组相比,可控弯组角度可控,单次消融面积较大(2.282 5 mm2 vs 1.135 8 mm2P<0.000 1)。
    结论 该新型可控弯等离子消融针角度弯曲可控、消融面积增大,实现穿刺对侧消融,且较安全。

     

    Abstract:
    Objective To verify the safety and effectiveness of a new percutaneous controllable curved plasma radiofrequency instrument for nucleus pulposus ablation.
    Methods A new percutaneous controllable curved plasma radiofrequency instrument were designed (controllable curved group), and its ablation effect was compared with the currently used straight head non-bendable plasma ablation instrument (non-bendable group) on gross specimens. The ablation instrument was placed through the right intervertebral foramen, and continuous ablation on the same intervertebral disc was conducted for three times. The ablation range and trajectory were recorded, and the temperature changes in the front, back, left, and right of the ablation center during and 15 seconds after ablation were monitored by the inserted temperature probe.
    Results There were no difference in temperature changes in the front, back, right regions of the ablation center during and 15 seconds after ablation between the two groups. The temperature changes in the left region of the ablation center both during and 15 seconds after 3rd ablation were larger than those in the non-bendable group (P<0.01). Compared with the non-bendable group, the controllable curved group achieved angle control and larger single ablation area (2.282 5 mm² vs 1.135 8 mm², P<0.000 1).
    Conclusions This new percutaneous controllable curved plasma ablation instrument can achieve angle control and ablation on the side opposite to the puncture site, increase ablation volume, and is safe.

     

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