Novel Venous Device for the Treatment of Chronic Pelvic Pain

项目摘要 慢性盆腔疼痛（CPP）是一种使人衰弱的疾病，影响了20%的女性， 美国的不幸的是，CPP的诊断和治疗是一个挑战，因为有多种 疾病病因由于其复杂性，它往往需要多学科的方法， 妇科医生、泌尿科医生、血管外科医生和介入放射科医生。CPP是强有力的 与生活质量的重大损害有关，并对心理健康产生负面影响。 健康它是女性健康中最常见的治疗条件之一，代表了一种 这给妇女和保健系统带来了沉重的经济负担。事实上，超过39美元 仅在美国，每年用于CPP的直接和间接成本就高达10亿美元。 不幸的是，许多CPP患者最终在急诊室或初级保健诊所 他们在那里接受阿片类药物治疗。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患者采用镇痛药，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。作为 阿片类药物不推荐用于CPP，医生需要更多的选择来成功治疗这种疾病。 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， 有助于诊断和治疗CPP。高达40%的CPP病例是由盆腔静脉引起的 盆腔充血综合征（pelvic congestion syndrome，PCS）是一种常见的盆腔充血综合征。肺静脉隔离发生在 卵巢或髂内静脉的逆行血流。这会导致血液停滞，导致 局部静脉缺氧，进而激活局部炎症和疼痛激活 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盆腔静脉引起的肺静脉隔离的系统 压缩（PVC）。除了提供良好的可视化功能不全的骨盆 静脉，V-Flow V-Gauge导管的一个关键优势是其能够确定临床 压缩区的显著压力梯度，并预先确定临床受益 通过实时压力监测来放置支架。该项目利用绵羊模型， 评价导管和支架中支架系统的安全性和有效性， 成功的设备将改善数百万患有CPP的妇女的临床结果 每年.

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.