PRODUCTION OF A PERICARDIAL PRIMARY REFERENCE MATERIAL

心包主要参考材料的生产

• 批准号: 2030976
• 负责人: MARK D LAUREN
• 金额: $ 9.94万
• 依托单位: COLUMBIA LABORATORIES
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-05-01 至 1997-10-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2030976
• 关键词: animal tissue; bioengineering /biomedical engineering; biomaterial development /preparation; biomaterial evaluation; biotechnology; collagen; cow; histology; light microscopy; pericardium; tensile strength; tissue /cell culture; tissue /cell preparation

DESCRIPTION (Adapted from applicant's abstract): Tissue biomaterials are used in a variety of medical devices including cardiac valves, vascular grafts, surgical patches and supports and various skin substitutes. This Phase I research proposes methods for the production and characterization of a primary reference material (PRM) using bovine pericardium as a starting material. The program involves the production of small batches of pericardial PRM followed by preliminary characterization of the bulk and surface properties to assess the feasibility of using pericardium as a tissue PRM. This work will result in the first tissue biomaterial to be commercially available outside the clinical setting. The pericardial PRM will be commercialized as a standard for calibration of physicochemical and biological tests. The fabrication of PRM will provide a source of well characterized, stable, tissue-based material to biomaterials investigators and medical device developers.

描述(摘自申请者摘要)：组织生物材料 用于各种医疗器械，包括心脏瓣膜、血管 移植物、外科贴片和支撑物以及各种皮肤替代品。这 第一阶段研究提出了生产和表征的方法。 以牛心包为对照的初级标准物质(PRM)的制备 开始的素材。该计划涉及小批量生产。 心包PRM，随后对大块进行初步鉴定 和表面特性来评估心包作为 一种组织PRM。这项工作将导致第一个组织生物材料 在临床环境之外的商业上可用。心包PRM 将被商业化，作为物理化学校准的标准 和生物测试。PRM的制造将提供一个来源 充分表征、稳定、基于组织的材料到生物材料 调查人员和医疗器械开发商。