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; 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）肝活检在评估各种急性和慢性肝脏疾病时广泛实施。当前技术的局限性主要与常规抽吸“ Menghini” - 式针或切割针的可能出血并发症有关。 III严重患者，这需要进行更具侵入性和昂贵的外科手术或荧光镜透性活检技术的表现，或者在没有损害治疗计划的活检的情况下对患者进行治疗。在较小的急性情况下，即使是常规活检的轻微出血也可能是生物后疼痛的根源，需要扩展后期治疗和镇痛药。我们的假设是，从肝脏中撤出当前的活检针会导致组织的轻微出血，从而导致患者疼痛和不适以及额外的住院费用。该建议的目的是设计和制造功能性原型经皮活检针，能够获得质量组织核心诊断的质量核心，并自动将止血塞入活检区。我们的最终目标（第二阶段）是构建一种廉价的设备，该设备将在常规门诊或床边设置中提供更安全，更疼痛的活检，并在急性肝功能障碍的情况下进行侵入性的经皮活检。使用抽吸技术将允许比切针的核心更长，该切割针的限制受试样槽的长度限制，因此有时需要多个活检通过才能获得令人满意的组织。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：保守地估计，每年在美国每年进行30,000多次肝活检。这个数字不包括那些病得很厉害的患者，但许多患者可能有资格止血，风险/益处率很高。随着这种活检针的成功开发，风险/福利比将改变以增加设备的使用情况，并获得当前市场的可观份额并降低患者护理成本。