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.

项目摘要 慢性骨盆疼痛（CPP）是一种使人衰弱的疾病，影响了20％的女性 美国。不幸的是，CPP是诊断和治疗的挑战 疾病病因。由于其复杂性，它通常需要一种涉及多学科的方法 妇科医生，泌尿科医生，血管外科医生和介入放射学家。 CPP强烈 与生活质量的重大影响相关，并对心理产生负面影响 健康。它是妇女健康中最常见的疾病之一，代表 妇女和卫生保健系统的大量经济燃烧。实际上，超过39美元 每年仅美国CPP的直接和间接费用花费了十亿美元。 不幸的是，许多CPP患者最终进入急诊室或初级保健诊所 在哪里开处方阿片类药物进行治疗。 2019年，美国慢性疼痛的美国成年人中有22.1％ 使用了处方。多达58％的CPP患者进入镇痛药，包括 OOID。研究表明，OOid治疗对慢性疼痛综合征无效。作为 不建议CPP使用Opioids，医生需要更多的选择来成功治疗这一点 衰弱的状况。 幸运的是，V-Flow Medical正在为CPP患者提供创新的解决方案 帮助诊断和治疗CPP。多达40％的CPP病例是由骨盆静脉引起的 功能不全（PVI），也称为盆腔充血综合征（PC）。当有PVI时发生 卵巢或内部静脉内的逆行血流。这会导致血液停滞，导致 局部静脉缺氧，进而激活局部感染并激活疼痛 伤害感受器。 V-Flow Medical设计了第一个诊断导管和模块化支架 专门设计用于治疗由骨盆静脉引起的PVI的系统 压缩（PVC）。除了提供无能的骨盆的出色可视化外 静脉，V-Flow V-Gauge导管的关键优势是它在临床上确定的能力 跨压缩区和预确定的临床益处的明显压力梯度 通过实时压力监测放置支架。该项目利用卵子模型 评估导管和支架内部系统的安全性和效率，以生成一个 成功的设备将改善数百万患有CPP的女性的临床结果 每年。