Bipolar Coagulation of Occluding Tissue in VP Shunts

VP 分流中闭塞组织的双极电凝

• 批准号: 7154165
• 负责人: JAMES Hunter GOLDIE
• 金额: $ 13.79万
• 依托单位: INFOSCITEX CORPORATION
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-01 至 2007-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7154165
• 关键词: brain; electrodes; model; tissues

DESCRIPTION (provided by applicant): Development of a bipolar coagulator is proposed for electrosurgical coagulation or cutting of adherent brain tissue that is occluding the flow of cerebrospinal fluid (CSF) into the intake holes of an implanted ventricular catheter. Currently, during revision surgery for ventriculoperitoneal (VP) shunts, monopolar coagulators are used to clear the occluding tissue, either to reestablish the function of the catheter or to allow it to be safely removed and replaced. For this application, however, bipolar coagulators offer better control of the distribution of the electrical current and may reduce the likelihood of serious complications. In particular, blood vessel damage and severe subarachnoid hemorrhages in some patients have been associated with the use of monopolar coagulation in VP shunt revision surgery. The proposed Phase I project will first establish a User Requirements Specification and then develop a set of prototypes for bipolar coagulators with electrode configurations suitable for operation inside a ventricular catheter. The prototypes will be integrated with available electro-surgical generators and inserted into ventricular catheters which have been immersed in fresh egg white. The testing will compare the bipolar prototypes with currently-used monopolar stylets with regard to the volume of coagulum produced, in order to accomplish a given coagulation task. As a last step, electrocautery will be applied to sheep brain tissue, obtained frozen from a suitable supplier, and analysis of the resulting lesion sizes will allow correction, if necessary, of the results obtained in egg white for brain tissue. Phase II is expected to verify the hypothesized benefits of bipolar coagulation in this application with animal models. Ventriculoperitoneal shunts are a life-saving treatment for hydrocephalus patients, but shunt catheters commonly become blocked over time and must be replaced to resolve this life-threatening situation. Neurosurgeons routinely employ off-label use of monopolar cautery to reduce the known risk of intraventricular hemorrhage (IVH) during the roughly 23,000 ventricular catheter revisions performed each year in the United States. However, IVH remains a risk, and recent case studies suggest an emerging risk of aneurysm formation associated with monopolar cautery in this application. The proposed bipolar coagulator is intended as a safer means for removal of occluded ventricular catheters from hydrocephalus patients undergoing shunt revision surgery.

描述（由申请人提供）：建议开发双极凝固器，用于电外科凝固或切割粘附的脑组织，该脑组织阻塞脑脊液（CSF）流入植入的心室导管的吸入孔。目前，在脑室腹膜（VP）分流术的翻修手术中，使用单极凝固器来清除闭塞组织，以重建导管的功能或使其能够安全地移除和更换。然而，对于这种应用，双极凝固器可以更好地控制电流的分布，并且可以减少发生严重并发症的可能性。特别是，一些患者的血管损伤和严重蛛网膜下腔出血与 VP 分流翻修手术中使用单极凝固有关。拟议的第一阶段项目将首先建立用户需求规范，然后开发一套双极凝固器原型，其电极配置适合在心室导管内操作。这些原型将与现有的电外科发生器集成，并插入已浸入新鲜蛋清的心室导管中。该测试将比较双极原型与当前使用的单极管心针产生的凝固物的体积，以完成给定的凝固任务。最后一步，将对从合适的供应商处获得的冷冻绵羊脑组织进行电灼，并对所得病变大小进行分析，如有必要，可对脑组织蛋清中获得的结果进行校正。第二阶段预计将通过动物模型验证双极凝固在该应用中的假设益处。脑室腹腔分流术是脑积水患者的一种挽救生命的治疗方法，但分流导管通常会随着时间的推移而堵塞，必须更换以解决这种危及生命的情况。在美国每年进行约 23,000 次心室导管翻修手术期间，神经外科医生通常会超说明书使用单极烧灼来降低已知的脑室内出血 (IVH) 风险。然而，IVH 仍然是一种风险，最近的案例研究表明，该应用中出现了与单极烧灼相关的动脉瘤形成风险。所提出的双极凝固器旨在作为一种更安全的方法，用于从接受分流修复手术的脑积水患者中移除闭塞的心室导管。