Fine Needle Aspiration Biopsy(FNAB) Needle Device

细针抽吸活检 (FNAB) 针装置

• 批准号: 6442998
• 负责人: VINOD B SHIDHAM
• 金额: $ 9.91万
• 依托单位: BIOINNOVATION, LLC
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-05-01 至 2003-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6442998
• 关键词: bioengineering /biomedical engineering; biomedical equipment development; biopsy; cytology; ethylenediaminetetraacetate; fine needle aspiration; fluorocarbon polymers; hypodermic needle; sample collection; surface coating

Fine Needle Aspiration Biopsies (FNAB) are widely performed due to their minimally invasive nature, low cost, and rapid turn around time for the diagnosis of various mass lesions such as cancer and infection. With increasingly, their use is expected to increase further mainly due to the escalating incidence of cancer. In the future, with the prevalence of in s- situ molecular techniques., FNAB will be the predominant and preferred method of tissue retrieval. Currently adapted hypodermic needles used for performing FNAB have many limitations including low reproducibility for adequate sampling A needle device that can overcome these drawbacks, therefore, has worldwide commercial potential. The present device is designed for a significantly higher and reproducible yield of diagnostic material even with minimum technical skill. This research is for finalizing he design to generate a prototype and prepare additional working models of this novel system. Tissue retrieval with these working models will be compared quantitatively and qualitatively with conventional hypodermic needs by performing experimental FNAB on beef liver. Depending on the results of this feasibility study, the molds of the final product will be made during phase II of the clinical trials are preparation towards commercialization (phase III). PROPOSED COMMERCIAL APPLICATIONS: This product has a worldwide market and could be easily marketed by many vendors. The average cost per unit would be $5 and is comparable to the cost of material currently used during FNAB procedure with modified hypodermic needle. Apart from the worldwide market, the potential market in United States alone should exceed $1,500,000 per year.

细针吸取活检(FNAB)因其微创、低成本和快速周转时间而被广泛应用于各种肿块病变的诊断，如癌症和感染。随着越来越多的人使用，预计它们的使用将进一步增加，这主要是由于癌症发病率的不断上升。在未来，随着S原位分子技术的普及，FNAB将成为组织检索的主要和首选方法。目前用于FNAB的改良型皮下注射针有许多局限性，包括用于足够采样的重复性低。因此，一种可以克服这些缺点的针具具有全球商业潜力。本设备的设计目的是即使在最低的技术技能下也能获得显著更高和可重复性的诊断材料。这项研究是为了完成设计，以生成一个原型，并准备这个新系统的额外工作模型。通过对牛肝脏进行实验性的FNAB，使用这些工作模型的组织检索将与传统的皮下需求进行定量和定性的比较。根据这项可行性研究的结果，最终产品的模具将在临床试验准备商业化的第二阶段(第三阶段)进行。建议的商业应用：该产品拥有全球市场，可以很容易地被许多供应商销售。每个单位的平均成本为5美元，与目前FNAB手术中使用改进的皮下注射针的材料的成本相当。除全球市场外，仅美国的潜在市场每年应超过150万美元。