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Vasodilation Needle for Trans-Radial Access

用于经桡动脉通路的血管舒张针

基本信息

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
项目类别：
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

项目摘要

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