SURFACE MODIFICATION TO IMPROVE BREAST PROSTHESES

表面修饰以改进乳房假体

• 批准号: 2096640
• 负责人: DAVID L CLAPPER
• 金额: $ 30.74万
• 依托单位: SURMODICS, INC.
• 依托单位国家: 美国
• 财政年份: 1992
• 资助国家: 美国
• 起止时间: 1992-05-01 至 1998-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2096640
• 关键词: biomaterial compatibility; breast implants; collagen; fibronectins; fibrosis; hardness; hyaluronate; mammary gland; prosthesis; scanning electron microscopy; silicone rubber; surface property; swine; tissue engineering

Contraction of fibrous capsules which form around breast prostheses remains the most common complication of breast reconstruction procedures. The goal of this Phase II project is to develop a combination of surface modifications for breast prostheses that will improve tissue bonding to the silicone (SR) surfaces, while decreasing inflammation, fibrous capsule thickness, and capsular contraction. The study will combine three approaches which have been shown to modulate these tissue responses: l) surface porosity of the prostheses, 2) proteins covalently coupled to the prostheses, and 3) fibrosis-inhibiting carbohydrates applied on top of the protein coatings. The surface characteristics of the coated prosthesis materials will be analyzed for uniformity of coating, and the mechanical properties will he tested before and after surface modification. Cell culture assays will evaluate the in vitro bioactivity of each coating and the effects of sterilization, drying and storage on the coatings. Finally, the modified prostheses will be implanted subcutaneously in pigs for 16 weeks. Clinical evaluation for tissue hardness will be assessed by indentation tonometry. Tissue surrounding the implants will be evaluated histologically for bonding to the SR, the presence of inflammatory cells, and the thickness and architecture of collagen in the capsules. PROPOSED COMMERCIAL APPLICATION: Two million Americans have breast prostheses, with contraction of fibrous capsules being the most common complication. The proposed surface modifications should improve the performance of breast prostheses by greatly decreasing capsule formation and contracture.

乳房假体周围纤维囊的收缩 仍然是乳房再造手术最常见的并发症。 第二阶段项目的目标是开发一种结合表面 对乳房假体进行修改，以改善组织粘合， 硅胶（SR）表面，同时减少炎症、纤维囊 厚度和囊收缩。这项研究将联合收割机 已经显示出调节这些组织反应的方法：1） 假体的表面孔隙率，2）共价偶联到假体的表面孔隙率的蛋白质， 假体，和3）纤维化抑制碳水化合物施加在顶部的 蛋白质涂层。涂层假体的表面特征 将分析材料的涂层均匀性和机械性能。 测试了表面改性前后的性能。细胞 培养试验将评价每种涂层的体外生物活性， 灭菌、干燥和贮存对涂膜的影响。 最后，将改良的假体植入猪的皮下 16周 组织硬度的临床评价将通过以下方式进行评估： 压痕眼压测量法将对植入物周围的组织进行评价 组织学上与SR结合，炎性细胞的存在， 以及胶囊中胶原蛋白的厚度和结构。 建议的商业应用：200万美国人有乳房 假体，纤维囊收缩是最常见的 并发症建议的表面改性应改善 通过大大减少囊形成的乳房假体的性能 和挛缩。