摘要
目的:验证国产脊髓电刺激(spinal cord stimulation,SCS)系统的可操作性、长期安全性和组织相容性.方法:成年雄性小尾寒羊9只,其中3只为短期植入组(S组)即SCS电极植入2周;另6只为长期植入组(L组)即SCS电极和脉冲发生器植入长达26周.观察术前(T0)、术后1周(T1)、2周(T2)、4周(T3)、8周(T4)、12周(T5)、20周(T6)、26周(T7)实验羊的行为学改变、实验室检查、设备电阻抗值、高频低频刺激情况、电极移位等,S组和L组分别于术后2周和26周取SCS周围组织行苏木精-伊红染色行病理性检查.结果:S组和L组植入SCS后运动正常.与术前相比,S组与L组的血常规、肝肾功能和凝血功能无明显变化(P>0.05).但与术前相比,L组实验羊血糖水平在术后 2、4、8、12 周均明显降低(P<0.05).术中及术后阻抗值正常,电极未见移位.刺激节段脊髓形态结构正常,未见明显坏死、水肿、缺血、炎症等病理改变.结论:国产植入式SCS系统可操作性良好,长期植入后具有良好的生物相容性和安全性,符合临床应用需求.
Abstract
Objective:To assess the efficacy,enduring safety,and histocompatibility of the indigenously developed implantable spinal cord stimulation(SCS)system.Methods:A cohort of nine Small-tailed Han sheep was selected for the study.Three were subjected to SCS implantation for two weeks(group S).The remaining six sheep underwent a more prolonged implantation of SCS for 26 weeks(group L).Parameters such as behavioral responses,laboratory assessments,device electrical impedance,effects of both high and low-frequency stimulation,and the potential displacement of electrodes were evaluated at pre-operative(T0),1 week(T1),2 weeks(T2),4 weeks(T3),8 weeks(T4),12 weeks(T5),20 weeks(T6),and 26 weeks(T7)after SCS implantation.Additionally,hematoxylin-eosin staining of tissues surrounding the electrodes,as well as other relevant tissues,were analyzed at 2 weeks and 26 weeks post-SCS.Results:After the implantation of SCS,both the S group and L group exhibited normal motor functions.Compared to the preoperative period,there were no significant changes in the complete blood count,liver and kidney functions,and coagulation functions in both the S group and L group(P>0.05).However,compared to the preoperative period,the blood glucose levels in the L group animals significantly decreased at 2 weeks,4 weeks,8 weeks,12 weeks(P<0.05).The impedance values during and after surgery were normal,and no electrode displacement was observed.The morphology and structure of the spinal cord at the stimulated segments appeared normal,with no evident necrosis,edema,ischemia,or inflammation observed.Conclusion:The study conclusively demonstrates that the domestically developed implantable SCS system possesses robust functionality,exemplary biocompatibility,and sustained safety over prolonged periods of implantation.These attributes collectively affirm its potential suitability and applicability for clinical use.
基金项目
浙江省科技厅领雁研发攻关计划(省重点研发)(2022C03081)
浙江省自然科学基金青年项目(LQ22H090022 Nur77)
NETL
NSTL
万方数据