Sealing Liver Biopsy Tracts with Hydrogels

用水凝胶密封肝活检管

• 批准号: 7106143
• 负责人: LUCJAN J J HRONOWSKI
• 金额: $ 10万
• 依托单位: BIOPSY SCIENCES, LLC
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-07-01 至 2007-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7106143
• 关键词: biological models; biomaterial compatibility; biomaterial development /preparation; biomaterials; biopsy; gel; histology; liver; swine; tissue /cell preparation

DESCRIPTION (provided by applicant): Many experts consider the liver biopsy to be the most specific diagnostic tool used to assess the nature and severity of liver disease. There are many important reasons for performing liver biopsies, such as accurate diagnosing or ruling out any coexisting liver disease, staging and grading the severity of HCV disease, treatment decisions, patient and provider reassurance, and as a benchmark to gauge or measure future disease progression. Furthermore, diagnosis of hemochromatosis, occult hepatitis B and non-alcoholic steatosis can only be made by a liver biopsy and can have an important impact on the treatment and prognosis of hepatitis C. The most common type of liver biopsy is a percutaneous (through the skin) needle biopsy. Ultrasonography or Computed Tomography (CT) scans may be used to aid in the procedure to identify lesions in the liver and pinpoint the exact point in which the needle will be inserted. Approximately 30% of people biopsied experience mild and moderate pain during and after the procedure. Complications for the procedure are another area of concern, but are generally uncommon. It is estimated that 3 biopsies per 1,000 have complications and 3 per 10,000 result in death. Also, there is an immeasurable but substantial population that need a liver biopsy performed, but cannot because of high risk of hemorrhaging. The risk of post-biopsy hemorrhagic complications is particularly great in patients with coagulopathy or therapeutic anticoagulation, such as patients undergoing dialysis, those with hepatic failures or those with transplants. The severe bleeding complications are related to the puncture of the liver capsule during biopsy, thereby allowing blood to escape into the peritoneal space, which can result in life threatening bleeding and even death. The deployment of a dehydrated hydrogel plug (Bio-Seal) into the biopsy tract across the liver capsule which expands in vivo rapidly to mechanically seal the biopsy tract may benefit all patients that need and have been denied a liver biopsy. This Phase I proposal will explore the feasibility of using Bio-Seal biopsy tract sealant as an effective plug following a liver biopsy in the porcine model (for both acute and chronic studies). The long-term objectives are to obtain FDA clearance and commercially sell the Bio-Seal system to seal biopsy tracts after liver and kidney biopsies. Bio-Seal has already been granted FDA clearance for the lung.

描述（由申请人提供）：许多专家认为肝活检是用于评估肝病性质和严重程度的最具体的诊断工具。进行肝活检有许多重要原因，例如准确诊断或排除任何共存的肝病、对 HCV 疾病的严重程度进行分期和分级、治疗决策、让患者和提供者放心，以及作为衡量或衡量未来疾病进展的基准。此外，血色素沉着症、隐匿性乙型肝炎和非酒精性脂肪变性只能通过肝活检来诊断，对丙型肝炎的治疗和预后有重要影响。最常见的肝活检类型是经皮（通过肝活检）皮肤）针吸活检。超声检查或计算机断层扫描 (CT) 扫描可用于帮助识别肝脏病变并精确定位针插入的确切位置。大约 30% 的活检患者在手术过程中和手术后会经历轻度和中度疼痛。该手术的并发症是另一个值得关注的领域，但通常并不常见。据估计，每 1,000 人中有 3 人出现并发症，每 10,000 人中有 3 人导致死亡。此外，还有不可估量但数量巨大的人群需要进行肝活检，但由于出血风险较高而无法进行。对于患有凝血障碍或治疗性抗凝的患者，例如接受透析的患者、肝功能衰竭或接受移植的患者，活检后出血并发症的风险特别大。严重的出血并发症与活检时刺穿肝包膜，从而使血液逸入腹膜腔有关，可能导致危及生命的出血甚至死亡。将脱水水凝胶塞（Bio-Seal）部署到穿过肝包膜的活检道中，该凝胶塞在体内迅速膨胀以机械密封活检道，这可能使所有需要肝活检但被拒绝进行肝活检的患者受益。该第一阶段提案将探讨在猪模型中进行肝活检后使用 Bio-Seal 活检道密封剂作为有效塞子的可行性（用于急性和慢性研究）。长期目标是获得 FDA 许可并商业销售 Bio-Seal 系统，以在肝脏和肾脏活检后密封活检道。 Bio-Seal 已获得 FDA 批准用于肺部。