Prototype development and validation of soft robotic sensor arrays for mapping cardiac arrhythmia

用于绘制心律失常的软机器人传感器阵列的原型开发和验证

• 批准号: 10722857
• 负责人: Simon Dunham
• 金额: $ 31.45万
• 依托单位: WEILL MEDICAL COLL OF CORNELL UNIV
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-04-15 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10722857
• 关键词: 3D Print; Ablation; Acute; Address; American; Anatomy; Animal Model; Animals; Area; Arrhythmia; Articulation; Atrial Fibrillation; Blood flow; Cardiac; Catheters; Collection; Complex; Development; Device Designs; Devices; Disease; Doctor of Philosophy; Electrocardiogram; Electrodes; Electrophysiology (science); Ensure; Heart Atrium; Hour; In Vitro; International; Left atrial structure; Maps; Measurement; Methods; Modeling; Names; Nature; New Device Approvals; Operative Surgical Procedures; Pathway interactions; Patients; Performance; Pharmacologic Substance; Phase; Play; Polyurethanes; Positioning Attribute; Procedures; Process; Protocols documentation; Pulsatile Flow; Resolution; Robotics; Series; Signal Transduction; Societies; Source; Speed; Standardization; Stretching; Stroke prevention; System; Techniques; Technology; Testing; Tissues; Translations; Validation; cardiac device; cardiac implant; design; design verification; electronic sensor; experience; experimental study; flexibility; flexible electronics; improved; in vivo; iterative design; manufacture; mechanical properties; minimally invasive; nitinol; novel; pressure; prevent; process optimization; prototype; safety assessment; sensor; side effect; spatiotemporal; success; three-dimensional modeling; tool; usability; verification and validation; working group

ABSTRACT Roughly 20,000 patients per year are treated with ablation to treat atrial fibrillation (AF) because their condition cannot be managed by pharmaceuticals alone. While ablation protocols exist that can treat the disease in many cases, these procedures can be lengthy (2-4 hours) and are only somewhat effective (~60-70% success). This speed of the procedure is limited by electrophysiology tools, which still require serial mapping of the atrium based on articulating an electrode (or electrode array) around the patient anatomy. Furthermore, because AF is an unstable arrhythmia, it is difficult to construct full spatiotemporally resolved electrocardiograms from this type of serial mapping. The small subset of devices that provide simultaneous mapping of the entire chamber have serious limitations and often leave large portions of the chamber unmapped. Here, we propose the use of a flexible and conformal soft robotic sensor array that allows for rapid, efficient and high resolution mapping of the left atrium for treatment of AF. Our lab has already established prototype devices based in vitro assessments in patient specific 3D print models. In this proposal, we will develop an optimized prototype, and associated catheter, based on a series of in vivo surgical and finally, percutaneous large animal studies. Once optimized, during the R33 phase, we will perform a series of device validation protocols based on ISO and ASTM standards. Finally, during the R33 phase of the proposal we will validate the system in vivo using large animal models.

抽象的 每年大约有20,000名患者通过消融治疗以治疗房颤（AF），因为他们的病情 不能仅由药物管理。虽然存在可以在许多人中治疗该疾病的消融方案 案例，这些程序可能是冗长的（2-4小时），并且仅有效（成功约为60-70％）。这 该过程的速度受到电生理工具的限制，该工具仍需要基于中庭的串行映射 在患者解剖结构周围表达电极（或电极阵列）时。此外，因为AF是一个 不稳定的心律失常，很难从这种类型 串行映射。提供整个腔室的同时映射的设备的一小部分具有 严重的局限性，通常会留下大部分腔室的限制。在这里，我们建议使用 柔性和共形软机器人传感器阵列，可快速，高效且高分辨率映射 离开心房治疗AF。我们的实验室已经建立了基于体外评估的原型设备 患者特定的3D打印型号。在此提案中，我们将开发一个优化的原型和相关的原型 导管基于一系列体内手术，最后是经皮大型动物研究。一旦优化， 在R33阶段，我们将基于ISO和ASTM标准执行一系列设备验证协议。 最后，在提案的R33阶段，我们将使用大动物模型在体内验证系统。