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 使用经桡动脉通路 (TRA) 方法进行的经皮动脉通路手术的数量正在不断增加 在美国迅速发展。由于出血风险较低，介入医生正在采用 TRA 技术 并且不需要主动血管闭合装置。 TRA 导管插入术也使患者满意，因为增加了 舒适性和机动性。通常可以当天出院，这降低了患者和健康的成本 保险公司。桡动脉痉挛 (RAS) 是 TRA 遇到的最常见并发症 然而，该技术使得接近变得困难和/或导致护套卡住。 RAS 可能会给患者带来痛苦 并且对于介入医生来说很难管理。使用多种药物，但有两种 该策略存在问题。首先，目前尚无普遍接受的、经证实有效的药物治疗方案。 RAS。其次，只有在问题出现后才开始药物治疗。自从临床上 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缓解这一并发症； 即，通过使用带电针（e针）对桡动脉平滑肌细胞进行电诱导松弛。我们的 初步数据表明，桡动脉因细胞外电刺激而扩张 电极。这一观察结果使我们推测 TRA 装置可以转化为血管舒张装置 细胞外电极（由皮肤贴片电极提供返回路径）。我们的目标是组装一个 原型装置并证明其在猪体内的安全性和有效性。新型接入电子针将 在超声引导下用于同时测量桡动脉直径并评估原型功效。 此外，安全性将通过测量期间的心电图和动脉血压来确定。 原型使用以及猪桡动脉移植后的组织病理学。我们的 RAS 新颖方法 有望改变当前的临床范式，从药物管理的临时尝试之一（在 没有一致性，但有不良副作用（如低血压），基于充分理解的 生物物理和生物医学工程原理。我们的项目旨在改善患者护理并节省时间 医生使用新型 TRA 电子针扩张接触血管的动脉以进行通路。这将节省 患者经历血管痉挛的痛苦，消除不必要的药物的风险，降低 降低医疗成本，提高医生效率。