High Impedance Pacing Electrode with Novel Tine Fixation

描述（由申请人提供）：对充血性心力衰竭和心脏起搏技术的理解的进步扩大了双心室起搏的适应症。虽然目前95%的导联都是横贯置入，但将导联置入左心室的风险明显更高。因此，更需要更先进的心外膜导联设计，以及通过开胸或骨突下入路将这些装置置入左心室的工具。由于这些导线上的机械应变要大得多，固定机制必须非常安全，直到组织生长的慢性组织固定完成。导联移位和/或迁移仍然是起搏失败的主要原因。植入后最初几周阈值升高可能导致电池过早耗尽，产生不必要的高电压阈值，甚至可能需要更换引线。类固醇洗脱导联已成为标准做法，但创伤较小的插入系统和更具生物相容性的导联将提供更长期的潜力。具有传感能力的高阻抗电极结合这些特性将是心外膜铅的放置和治疗的一大进步。研究将集中在开发和实施一种新的心外膜铅固定系统和“智能起搏电极”。该方法将利用先进的机械设计和新材料技术来提供自动插入和固定引线。结合抗疤痕/抗炎药物治疗，这种新型导联系统可以降低起搏阈值，从而提高电力使用效率，延长电池寿命。主要目标将是利用创新的新技术开发一种可伸缩和可复位的被动固定系统。该固定系统将采用新的亲水聚合物药物输送系统，既提供流体动力密封，又将抗炎药物输送到植入部位。此外，MEMS技术将用于开发高阻抗电极，为集成新的传感器提供平台，以响应心脏活动的变化。一种高阻抗、低阈值的心外膜导联，具有一种新的被动固定机制，将用于推进需要左心室起搏的患者的治疗。

DESCRIPTION (provided by applicant): Advancements in the understanding of Congestive Heart Failure and the cardiac pacing technology has expanded the indications for bi-ventricular pacing. Although 95 % of all leads are currently placed transvenously, placement of leads into the left ventricle pose significantly higher risks for this approach. Hence, there is a greater need for more advanced myoepicardial lead designs as well as tools for placement of these devices into the left ventricle through a thoracotomy or sub-xyphoid approach. Because of the much greater mechanical strain on these leads, the fixation mechanism must be very secure until chronic tissue fixation, due to tissue in-growth, is complete. Lead dislodgement and/or migration remain a leading cause of pacing failure. Threshold rise in the first few weeks post implantation can lead to premature battery depletion, unnecessarily high voltage thresholds, or may even require lead replacement. Steroid eluting leads have become standard practice but a less traumatic insertion system and more biocompatible lead would offer much longer term potential. A high impedance electrode with sensing capabilities combined with these attributes would be a great advance for epicardial lead placement and treatment. The research will focus on the development and implementation of a new epicardial lead fixation system and a "smart pacing electrode". The approach will utilize advanced mechanical designs along with new material technology to provide an atraumatic insertion and fixation lead. Coupled with anti-scarring/anti-inflammatory drug therapy, this novel lead system will allow lower pacing thresholds leading to more efficient power use and longer battery life. The major aim will be to develop a retractable and repositionable passive fixation system utilizing innovative new technology. This fixation system will employ new hydrophilic polymer drug delivery systems to provide both a hydrodynamic seal as well as deliver anti-inflammatory drugs to the implantation site. Additionally, MEMS technology will be employed to develop a high impedance electrode that provides a platform for integration of new sensors to respond to changes in cardiac activity. A high impedance, low threshold epicardial lead, with a novel new passive fixation mechanism will be developed to advance treatment for patients requiring left ventricular pacing.