Novel Venous Device for the Treatment of Chronic Pelvic Pain

用于治疗慢性盆腔疼痛的新型静脉装置

• 批准号: 10696574
• 负责人: Rodney Brenneman
• 金额: $ 29.95万
• 依托单位: V-FLOW MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-08 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10696574
• 关键词: Accident and Emergency department; Address; Adult; Analgesics; Anatomy; Applications Grants; Biological Markers; Blood; Blood Vessels; Blood flow; Calibration; Cardiovascular system; Catheters; Clinical; Closure by clamp; Devices; Diagnosis; Diagnostic; Diameter; Direct Costs; Disease; Economic Burden; Ensure; Etiology; FDA approved; Facilities and Administrative Costs; Fluoroscopy; Gynecologist; Healthcare Systems; Histology; Hypoxia; Hysterectomy; Iliac Vein; Impairment; Inflammation; Intervention; Liquid substance; Measurement; Measures; Medical; Mental Health; Monitor; Nature; Nociceptors; Obstruction; Opioid; Outcome; Ovarian; Overweight; Pain; Patients; Pelvic Pain; Pelvis; Phase; Phlebography; Physicians; Procedures; Quality of life; Research; Resort; Risk; Safety; Small Business Innovation Research Grant; Stents; Surgeon; Swelling; Symptoms; Syndrome; System; Testing; Therapeutic Embolization; Time; Trauma; United States; Urologist; Veins; Venous; Venous Insufficiency; Visualization; Woman; Women' s Health; accurate diagnosis; chronic pain; chronic pelvic pain; clinical efficacy; clinically significant; design; diagnostic tool; effective therapy; efficacy testing; histological specimens; improved; innovation; interdisciplinary approach; minimally invasive; novel; pain reduction; pain relief; parous; prescription opioid; pressure; primary care clinic; radiologist; safety testing; sheep model; stent thrombus; success

PROJECT SUMMARY Chronic Pelvic Pain (CPP) is a debilitating condition that impacts 20 percent of women in the United States. Unfortunately, CPP is a challenge to diagnose and treat as there are multiple disease etiologies. Due to its complexity, it often requires a multidisciplinary approach involving gynecologists, urologists, vascular surgeons, and interventional radiologists. CPP is strongly associated with significant impairments in quality of life and has negative impacts on mental health. It is one of the most common conditions treated in women’s health and represents a substantial economic burden on women and health care systems. In fact, an excess of $39 billion USD is spent in direct and indirect costs for CPP in the United States alone each year. Unfortunately, many patients with CPP end up in emergency rooms, or in primary care clinics where they are prescribed opioids for treatment. In 2019, 22.1% of U.S. adults with chronic pain used a prescription opioid. Up to 58% of patients with CPP resort to analgesics including opioids. Research shows that opioid treatment is ineffective for chronic pain syndromes. As opioids are not recommended for CPP, physicians need more options to successfully treat this debilitating condition. Fortunately, V-Flow Medical is providing CPP sufferers with an innovative solution to help diagnose and treat CPP. Up to 40% of CPP cases are caused by pelvic venous insufficiency (PVI), also known as pelvic congestion syndrome (PCS). PVI occurs when there is retrograde blood flow in the ovarian or internal iliac veins. This causes blood stasis, leading to localized venous hypoxia, which in turn activates localized inflammation and activation of pain nociceptors. V-Flow Medical has designed the first diagnostic catheter and modular stent system that has been specifically designed to treat PVI that is caused by pelvic vein compressions (PVCs). In addition to providing excellent visualization of incompetent pelvic veins, a key advantage of the V-Flow V-Gauge catheter is its ability to determine a clinically significant pressure gradient across the compressed zone and pre-determine the clinical benefit of placing a stent through real-time pressure monitoring. This project utilizes an ovine model to evaluate the safety and efficacy of the catheter and stent-in-stent system to generate a successful device that will improve clinical outcomes for millions of women suffering from CPP each year.

项目总结 慢性骨盆疼痛(CPP)是一种使人虚弱的疾病，影响到20%的女性 美国。不幸的是，CPP的诊断和治疗是一个挑战，因为有多个 疾病病因学。由于它的复杂性，它通常需要多学科的方法，包括 妇科医生、泌尿科医生、血管外科医生和介入放射科医生。CPP是强有力的 与严重的生活质量障碍有关，并对精神产生负面影响 健康。它是女性健康中最常见的疾病之一，代表着一种 给妇女和卫生保健系统带来巨大的经济负担。事实上，超过39美元 仅在美国，每年在CPP的直接和间接成本上就花费了10亿美元。 不幸的是，许多CPP患者最终被送进急诊室或初级保健诊所。 在那里他们被开出阿片类药物进行治疗。2019年，22.1%的美国成年人患有慢性疼痛 使用了处方阿片类药物。高达58%的CPP患者求助于止痛药，包括 阿片类药物。研究表明，阿片类药物治疗对慢性疼痛综合征无效。AS 阿片类药物不推荐用于CPP，医生需要更多的选择才能成功治疗 使人虚弱的状况。 幸运的是，V-Flow Medical为CPP患者提供了一种创新的解决方案 帮助诊断和治疗CPP。高达40%的CPP病例是由盆腔静脉引起的 盆腔功能不全(PVI)，也称为盆腔充血综合征(PCS)。当存在以下情况时，会发生变坡点 卵巢或髂内静脉的逆行血流。这会导致血瘀证，导致 局部静脉缺氧，继而激活局部炎症和疼痛激活 痛觉感受器。V-Flow医疗公司设计了第一个诊断导管和模块化支架 专为治疗盆腔静脉引起的静脉曲张而设计的系统 压缩(PVC)。除了提供对不能胜任的骨盆的出色的可视化 静脉，V-Flow V-Gauge导管的一个关键优势是它能够在临床上确定 整个压缩区域的显著压力梯度，并预先确定临床益处 通过实时压力监测放置支架。该项目利用绵羊模型来 评估导管和支架内系统的安全性和有效性，以产生 成功的设备将改善数百万患有慢性阻塞性肺病的女性的临床结果 每年。