LIVER BIOPSY NEEDLE AND COAGULANT PLUG

肝脏活检针和凝固塞

• 批准号: 2791577
• 负责人: WILLIAM R. KRAUSE
• 金额: $ 10万
• 依托单位: BIOENGINEERING CONSULTANTS, LTD
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-04-01 至 2000-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2791577
• 关键词: biomedical equipment development; biopsy; blood coagulation; clinical biomedical equipment; diagnosis design /evaluation; fine needle aspiration; human tissue; liver; liver disorder diagnosis; liver function

Percutaneous (through the skin) liver biopsy is widely practiced in the evaluation of various acute and chronic liver disorders. Limitations of the current techniques are mainly related to the potential for bleeding complications with either of the conventional aspiration "Menghini"-style needle or cutting needles. Iii seriously ill patients, this necessitates either the performance of more invasive and expensive surgical or fluoroscopic transvenous biopsy techniques or treating the patient without the benefit of the biopsy which compromises therapeutic planning. In less acute situations, even minor bleeding from conventional biopsy may be the source of significant post-biopsy pain requiring extended post-procedure monitoring and analgesic medications. It is our HYPOTHESIS that withdrawal of the current biopsy needle from the liver causes minor bleeding of the tissue which results in pain and discomfort to the patient and additional hospitalization costs. The OBJECTIVE of this proposal is design and manufacture a functional prototype percutaneous biopsy needle capable of obtaining a quality core of tissue for diagnosis and automatically delivering a hemostatic plug into the biopsy tract. Our ultimate goal (Phase II) is to construct an inexpensive device which will provide a safer and less painful biopsy in the routine outpatient or bedside setting and a less invasive percutaneous biopsy in the setting of acute liver dysfunction. Use of the aspiration technique will allow a longer core than the cutting needle which is limited by the length of the specimen trough thus sometimes requiring more than one biopsy pass to obtain satisfactory amounts of tissue. Full automation of the method will enhance safety by decreasing the complexity of the procedure. PROPOSED COMMERCIAL APPLICATIONS: It is conservatively estimated that over 30,000 liver biopsies are performed annually in the United States. This number excludes those patients who are too ill to undergo the procedure, but many of whom may be eligible with hemostatic plugging, with a high risk/benefit ratio. With the successful development of this biopsy needle the risk/benefit ratio would change to favor the increased usage of the device as well as gaining a respectable share of the current market and reducing patient care costs.

经皮（通过皮肤）肝活检广泛用于评估各种急性和慢性肝脏疾病。当前技术的局限性主要与传统抽吸“Menghini”式针或切割针潜在的出血并发症有关。对于病情严重的患者，这需要进行更具侵入性且昂贵的手术或荧光镜经静脉活检技术，或者在没有活检益处的情况下治疗患者，这会损害治疗计划。在不太严重的情况下，即使是传统活检产生的轻微出血也可能是活检后明显疼痛的根源，需要长期的术后监测和镇痛药物。我们的假设是，从肝脏中拔出当前的活检针会导致组织轻微出血，从而导致患者疼痛和不适以及额外的住院费用。该提案的目的是设计和制造一种功能原型经皮活检针，能够获得用于诊断的优质组织核心，并自动将止血塞输送到活检道​​中。我们的最终目标（第二阶段）是构建一种廉价的设备，在常规门诊或床边提供更安全、更少痛苦的活检，并在急性肝功能障碍的情况下提供侵入性更小的经皮活检。使用抽吸技术将允许比切割针更长的芯，这受到样本槽长度的限制，因此有时需要多次活检才能获得满意的组织量。该方法的完全自动化将通过降低程序的复杂性来提高安全性。拟议的商业应用：据保守估计，美国每年进行超过 30,000 例肝脏活检。这个数字不包括那些因病重而无法接受手术的患者，但其中许多人可能符合止血堵塞的条件，且风险/效益比较高。随着这种活检针的成功开发，风险/效益比将发生变化，有利于增加该设备的使用，并在当前市场上获得可观的份额并降低患者护理成本。