Vasodilation Needle for Trans-Radial Access

用于经桡动脉通路的血管舒张针

• 批准号: 10005827
• 负责人: William Combs
• 金额: $ 37.66万
• 依托单位: 3DT HOLDINGS, LLC
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-26 至 2023-08-25
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10005827
• 关键词: Address; Adopted; Adoption; Anatomy; Angiography; Arteries; Biomedical Engineering; Biophysics; Blood Pressure; Blood Vessels; Blood gas; Caliber; Cardiology; Carotid stent; Catheterization; Catheters; Clinical; Complication; Consumption; Data; Development; Devices; Distal; Electric Stimulation; Electrocardiogram; Electrodes; Ensure; Equipment; Exhibits; Family suidae; Goals; Guidelines; Hand; Health Care Costs; Health Insurance; Hemorrhage; Histopathology; Hospitals; Hypotension; Improve Access; Injury; Intervention; Lymphatic; Measures; Medical; Medical Care Costs; Medical Device; Medication Management; Medicine; Methods; Needles; Outcome; Pain; Patient Care; Patients; Peripheral; Pharmaceutical Preparations; Pharmacological Treatment; Pharmacology; Phase; Physicians; Physiologic pulse; Prevention; Procedures; Protocols documentation; Radial; Regimen; Relaxation; Risk; Safety; Sampling; Seminal; Small Business Innovation Research Grant; Smooth Muscle; Smooth Muscle Myocytes; Spasm; Stents; Techniques; Technology; Testing; Therapeutic; Therapeutic Uses; Thumb structure; Time; Training; Translating; Ultrasonography; Vasodilation; Vasodilator Agents; Vasospasm; Walking; Workload; Wrist; base; cost; experience; extracellular; femoral artery; fovea centralis; improved; in vivo; novel; novel strategies; prevent; prototype; radial artery; renal artery; response; side effect; skin patch; success; treatment response

SUMMARY The number of percutaneous arterial access procedures using the transradial access (TRA) approach is growing rapidly in the US. Interventionalists are adopting the TRA technique due to lower risks associated with bleeding and no need for active vascular closure devices. TRA catheterization also satisfies patients because of increased comfort and mobility. Same-day discharge is generally possible, which lowers costs for patients and health insurance companies. Radial artery spasm (RAS) is the most common complication encountered with the TRA technique, however, making access difficult and/or causing sheath entrapment. RAS can be painful for patients and is difficult for interventionalists to manage. Various pharmacological agents are used, but there are two problems with that strategy. First, there is no generally accepted drug regimen with proven efficacy in treating RAS. Second, pharmacological treatment is initiated only after a problem has arisen. Since the clinically important problem of RAS persists, we propose a completely different approach to mitigating this complication; i.e., electrical-induced relaxation of radial artery smooth muscle cells by use of electrified needle (e-needle). Our preliminary data show that the radial artery dilates in response to electrical stimulation with extracellular electrodes. This observation leads us to hypothesize that TRA devices can be transformed into vasodilating extracellular electrodes (with the return path provided by a skin patch electrode). Our aim is to assemble a prototype device and demonstrate its safety and efficacy in vivo in swine. The novel access e-needle will be used under ultrasound guidance to simultaneously measure radial artery diameter and assess prototype efficacy. Further, safety will be determined by measuring the electrocardiogram and arterial blood pressure during prototype use as well as histopathology after explanting the swine radial artery. Our novel approach to RAS promises to shift the current clinical paradigm from one of ad hoc attempts at pharmacological management (in which there is no consistency, but undesired side effects like hypotension) to one based on well-understood biophysical and biomedical engineering principles. Our project offers to improve patient care and save time for physicians with a novel TRA e-needle that dilates the artery it contacts the vessel for access. This will spare patients the pain of experiencing vasospasm, eliminate risks from unnecessary pharmacological agents, lower medical costs, and improve physician efficiency.

概括 使用跨性别访问方法（TRA）方法的经皮动脉入学程序的数量正在增长 在美国迅速。干预主义者正在采用TRA技术，因为与出血相关的风险较低 并且无需主动血管闭合设备。 Tra导管插入术也满足患者的满足 舒适和机动性。通常可以使用当天出院，这降低了患者的成本和健康 保险公司。径向动脉痉挛（RAS）是TRA遇到的最常见的并发症 但是，技术使访问变得困难和/或引起护套夹带。 RA对患者可能很痛苦 干预主义者很难管理。使用了各种药理剂，但是有两个 该策略的问题。首先，没有公认的药物治疗方案 拉斯。其次，仅在出现问题后才开始药理治疗。自临床上 RAS的重要问题仍然存在，我们提出了一种完全不同的方法来减轻这种并发症。 即，通过使用电气针（E-Needle），电诱导的径向动脉平滑肌细胞松弛。我们的 初步数据表明，径向动脉响应细胞外电刺激而扩张 电极。该观察结果使我们假设可以将TRA设备转化为血管延伸 细胞外电极（带有皮肤贴片电极提供的返回路径）。我们的目标是组装 原型设备，并在猪体内证明其安全性和功效。新颖的访问电子启示将是 在超声指导下使用，以同时测量径向动脉直径并评估原型功效。 此外，将通过测量心电图和动脉血压来确定安全性 在外观察猪径向动脉后的原型使用以及组织病理学。我们对Ras的新方法 有望将当前的临床范式从药理管理的临时尝试之一转移 没有一致性，而是基于良好理解的不希望的副作用，例如低血压） 生物物理和生物医学工程原理。我们的项目提出了改善患者护理并节省时间 医师带有一种新型的Tra E-Needle，它可以扩张动脉，它与容器接触以获取。这将备用 患者经历血管痉挛的痛苦，消除了不必要的药理剂的风险，较低 医疗费用，并提高医师的效率。