新型植入式脊髓电刺激系统在羊的生物安全性和组织相容性研究

BIOSAFETY AND HISTOCOMPATIBILITY OF A NEW IMPLANTABLE SPINAL CORD STIMULATION SYSTEM IN SHEEP

摘要:

目的：验证新型植入式脊髓电刺激（spinal cored stimulation，SCS）系统的安全性、可操性和组织相容性。方法：小尾寒羊3只，在X线透视引导下行SCS植入术，植入穿刺电极、外科电极和脉冲发生器（implantable pulse generator，IPG），观察术后的动物行为学改变、血白细胞（white blood cell，WBC）水平、设备阻抗值。在术后1个月时取脊髓标本行苏木精-伊红（Hematoxylin eosin，HE）染色，观察SCS刺激节段与未刺激节段的脊髓结构。结果：实验羊的术后运动和感觉正常，术后WBC水平在正常范围内波动，术中、术后阻抗值正常，设备运转工作正常。与未刺激节段相比，刺激节段脊髓形态结构正常，未见明显细胞坏死、水肿、缺血、炎症等病理改变。结论：新型植入式SCS系统的生物安全性和可操作性良好，符合临床应用需求。

Abstract:

Objective: To verify the safety, operability, and histocompatibility of the new implantable spinal cord stimulation (SCS) system. Methods: Three small-tailed Han sheep were performed the SCS system implantation under X-ray fluoroscopy-guided. The percutaneous leads, paddle leads, and implantable pulse generators (IPG) were placed. The postoperative animal behavioral changes and blood white blood cell (WBC) counts and impedance were observed. Spinal cord specimens were taken at one-month post-operation for hematoxylin-eosin (HE) staining, and the spinal cord structures of SCS stimulated and unstimulated segments were observed. Results: The postoperative movement and sensation of the sheep were healthy, the postoperative blood WBC counts fluctuated within the normal range, the intraoperative and postoperative impedance values were typical, and the system operation was regular. Compared with the unstimulated segment, the morphological structure of the spinal cord in the stimulated segment was reasonable, and no apparent cell necrosis, edema, ischemia, inflammation, and other pathological changes were observed. Conclusion: The new implantable SCS system has excellent biological safety and operability, which meets the needs of clinical application.