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.

摘要 每年大约有20，000名患者接受消融治疗以治疗房颤（AF），因为他们的病情 单靠药物是无法控制的。虽然存在可以在许多情况下治疗疾病的消融方案， 在某些情况下，这些程序可能很长（2-4小时），并且只有一定的有效性（约60-70%的成功率）。这 该过程的速度受到电生理学工具的限制，电生理学工具仍然需要基于心房的连续标测。 在患者解剖结构周围铰接电极（或电极阵列）。此外，由于AF是一个 不稳定的心律失常，很难从这种类型的心电图中构建完整的时空分辨心电图。 串行映射提供整个腔室的同时标测的设备的小子集具有 严重的局限性，并往往留下大部分的腔室未映射。在这里，我们建议使用 灵活和适形的软机器人传感器阵列，允许快速，高效和高分辨率的测绘， 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打印模型。在本提案中，我们将开发一个优化的原型，并与之相关联， 导管，基于一系列的体内手术，最后，经皮大动物研究。一旦优化， 在R33阶段，我们将执行一系列基于ISO和ASTM标准的设备验证协议。 最后，在该提案的R33阶段，我们将使用大型动物模型在体内验证该系统。