PACING, SENSING AND DEFIBRILLATION ELECTRODE COATINGS

描述（由申请人提供）：提出了用于心脏起搏，传感和除颤电极的低极化涂层的开发。该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采用单一起搏和感应电极的自适应心率起搏的刺激后传感方法方面的需求。该涂层是一种还原-氧化（氧化还原）材料，具有定制的表面形态，可以在薄（< 150nm），物理和化学坚固的涂层中最大化低极化电荷注入。提出了氧化还原涂层在化学和沉积方面的创新，以提高其在体内的化学和物理稳定性。该涂层将容纳有机涂层，如聚乙二醇和类固醇洗脱膜，并允许化学表面修饰，以提高生物相容性和适度的纤维化组织封装。在第一阶段，涂层将应用于心内膜起搏和除颤电极。体外表征将包括起搏和除颤期间的极化、阻抗、在含有生理介质的生物分子中的稳定性以及在机械挑战下的稳定性。镀层的组成和形貌与其起搏和除颤电极性能之间的关系。在第一阶段，将引入有机表面处理，并进行测试，以建立体内慢性和功能稳定性。

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.