PACING, SENSING AND DEFIBRILLATION ELECTRODE COATINGS

描述(由申请人提供)：建议开发用于心脏起搏、传感和除颤电极的低极化涂层。这些涂层满足了心律管理行业在开发高阻抗、低极化起搏电极、低阻抗除颤电极以及使用单一起搏和传感电极的心率自适应起搏的刺激后传感方法方面的需求。该涂层是还原-氧化(Redox)材料，具有量身定制的表面形貌，最大限度地在薄(&lt；150 nm)、物理和化学坚固的涂层中注入低极化电荷。提出了氧化还原涂层的化学和沉积方面的创新，将提高体内化学和物理稳定性。这种涂层将适应有机涂层，如聚乙二醇膜和类固醇洗脱膜，并允许进行化学表面修饰，以提高生物相容性和适度的纤维组织包裹性。在第一阶段，涂层将应用于心内膜起搏和除颤电极。体外特性包括起搏和除颤过程中的极化、阻抗、在含有生理介质的生物分子中的稳定性和在机械挑战下的稳定性。涂层的组成和形貌与其起搏和除颤电极的性能之间的关系将被建立。在第一阶段，将引入有机表面处理并进行测试，以确定慢性体内和功能稳定性。 建议的商业应用：一种用于心脏起搏、除颤和传感电极的低极化涂层在极大的市场中具有商业潜力。除心脏应用外，该涂层还将适用于脑深部刺激、皮层刺激和记录，用于感觉和运动假体的功能性电刺激，以及用于癫痫的迷走神经刺激。这些都是不断增长的市场，在这些市场中，涂料的使用将具有明显的临床益处和巨大的商业潜力。

DESCRIPTION (provided by applicant): The development of low-polarization coatings for cardiac pacing, sensing and defibrillation electrodes is proposed. The coatings address the needs of the cardiac rhythm management industry in the development of high-impedance, low-polarization pacing electrodes, low impedance defibrillation electrodes, and post-stimulus sensing methodologies for rate adaptive pacing employing a single pacing and sensing electrode. The coatings are reduction-oxidation (redox) materials with tailored surface morphologies that maximize low-polarization charge injection in thin (<150 nm), physically and chemically robust coatings. Innovations in the chemistry and deposition of the redox coatings are proposed that will enhance in vivo chemical and physical stability. The coatings will accommodate organic overlayers, such as PEG and steroid eluting membranes, and allow chemical surface modification to improve biocompatibility and moderate fibrotic tissue encapsulation. In Phase I, the coatings would be applied to endocardial pacing and defibrillation electrodes. In vitro characterization would include polarization during pacing and defibrillation, impedance, stability in biomolecule containing physiologic media and stability under mechanical challenge. The relationship between composition and morphology of the coatings and their performance as pacing and defibrillation electrodes would be established. In Phase I, organic surface treatments would be introduced and testing to establish chronic in vivo and functionally stability undertaken. PROPOSED COMMERCIAL APPLICATION: A low-polarization coating for cardiac pacing, defibrillation and sensing electrodes has commercial potential in an extremely large market. Besides cardiac applications, the coatings will be suitable for deep-brain stimulation, cortical stimulation and recording in functional electrical stimulation for sensory and motor prostheses, and vagus nerve stimulation for epilepsy. These are growing markets in which the use of the coatings will have clear clinical benefit with significant commercial potential.