SURFACE MODIFICATION TO IMPROVE BREAST PROSTHESES

表面修饰以改进乳房假体

• 批准号: 3492929
• 负责人: DAVID L CLAPPER
• 金额: $ 5万
• 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 1993-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3492929
• 关键词: biomaterial development /preparation; biomaterial evaluation; biomaterials; collagen; contracture; extracellular matrix proteins; histocompatibility; histology; implant; mammary gland; photochemistry; polymers; radiotracer; silicone rubber; swine; tissue /cell culture

The greatest problem with current breast prostheses is the development of a contractile fibrous capsule. Capsular contracture produces breast hardening, pain, and distortion of the breast shape. This SBIR Phase I project proposes to combine two types of prosthesis surface modifications to reduce capsule formation and contracture. First, the prosthesis to be used will have a textured (porous) silicone rubber surface. Porous polymers are reported to improve tissue integration, decrease the size of fibrous capsules formed, and inhibit the ordered formation of collagen/myofibril layers that are typical of contracted capsules. Second, the textured surface will be coated with extracellular matrix (ECM) proteins and/or peptides to further improve tissue integration by promoting the attachment and ingrowth of breast tissue. Radiolabelled ECM proteins and peptides will be used to optimize immobilization efficiency on the prostheses, and their bioactivity will be evaluated in vitro by quantitating the attachment and growth of fibroblasts and epithelial cells. Coated prostheses will be implanted subcutaneously into pigs and histologically evaluated for tissue integration and fibrous encapsulation. Mammary prostheses are the most commonly used synthetic implants in the United States, and about 30% of these prostheses encounter significant problems with capsular contracture. Therefore, prostheses modifications that reduce the incidence of this problem would be extremely beneficial.

目前乳房假体最大的问题是 一种可收缩的纤维囊。包膜挛缩生乳房 乳房形状变硬、疼痛和变形。此SBIR第一阶段 该项目建议将两种类型的假体表面修改结合起来 以减少包膜的形成和痉挛。首先，假体是 使用时将有纹理(多孔)硅橡胶表面。多孔性 据报道，聚合物可以改善组织整合，缩小血管大小 纤维状胶囊的形成，并抑制有序的形成 胶原/肌原纤维层，这是收缩胶囊的典型特征。第二, 纹理表面将覆盖一层细胞外基质(ECM) 蛋白质和/或多肽通过促进 乳房组织的附着和生长。 放射性标记的ECM蛋白质和多肽将用于优化 假体的固定效率和生物活性将被 定量测定成纤维细胞贴壁和生长的体外评价 和上皮细胞。涂层假体将被植入皮下 并对组织整合和纤维化进行组织学评估 封装。 乳房假体是最常用的人造植入物。 美国，大约30%的假肢遇到了显著的 包膜痉挛的问题。因此，假体修复术 减少这个问题的发生将是非常有益的。