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.

总结 使用经桡动脉入路（TRA）的经皮动脉入路手术的数量正在增加 在美国迅速。介入医生采用TRA技术是因为出血相关风险较低 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 舒适性和移动性。当天出院通常是可能的，这降低了患者和健康的成本 保险公司桡动脉痉挛（RAS）是TRA最常见的并发症 然而，该技术使得进入困难和/或导致鞘管截留。RAS可能会给患者带来疼痛 并且对于介入治疗者来说很难管理。使用各种药理学试剂，但有两种 这个战略的问题。首先，没有普遍接受的药物治疗方案， RAS。第二，药物治疗只有在出现问题后才开始。由于临床上 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种并发症; 也就是说，通过使用电针（e-needle）电诱导桡动脉平滑肌细胞松弛。我们 初步数据显示桡动脉对细胞外刺激的电刺激作出反应而扩张 个电极这一观察结果使我们假设TRA器械可以转化为血管扩张 细胞外电极（具有由皮肤贴片电极提供的返回路径）。我们的目标是建立一个 原型装置，并证明其在猪体内的安全性和有效性。新的Access电子针将是 在超声引导下同时测量桡动脉直径并评估原型疗效。 此外，安全性将通过在治疗期间测量心电图和动脉血压来确定。 原型使用以及猪桡动脉结扎后的组织病理学。我们对RAS的新方法 有望改变目前的临床范式，从一个特设的尝试，在药理学管理（在 这是没有一致性，但不希望的副作用，如低血压），以一个基于良好的理解 生物物理和生物医学工程原理。我们的项目提供了改善病人护理和节省时间， 医生使用新型TRA电子针扩张其接触血管的动脉以进入。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，提高医生工作效率。