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

基本信息

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
项目类别：
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

项目摘要

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.

抽象的每年约有 20,000 名患者接受消融治疗心房颤动 (AF)，因为他们的病情仅靠药物无法控制。虽然存在可以治疗许多疾病的消融方案在某些情况下，这些程序可能会很长（2-4 小时）并且只有一定程度的效果（成功率约为 60-70%）。这该过程的速度受到电生理学工具的限制，该工具仍然需要基于心房的串行映射在患者解剖结构周围铰接电极（或电极阵列）。此外，由于 AF 是不稳定的心律失常，很难从这种类型的心律失常中构建完整的时空解析心电图串行映射。提供整个室同步测绘的一小部分设备具有严重的限制，并且常常使房间的大部分区域未绘制地图。在这里，我们建议使用一个灵活且共形的软机器人传感器阵列，可实现快速、高效和高分辨率的映射左心房用于治疗 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 打印模型。在这个提案中，我们将开发一个优化的原型，以及相关的导管，基于一系列体内手术以及最后的经皮大型动物研究。一旦优化后，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。