SURFACE MODIFICATION TO IMPROVE BREAST PROSTHESES

表面修饰以改进乳房假体

• 批准号: 2096639
• 负责人: DAVID L CLAPPER
• 金额: $ 44.26万
• 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 1997-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2096639
• 关键词: biomaterial compatibility; collagen; fibronectins; fibrosis; hardness; hyaluronate; mammary gland; prosthesis; scanning electron microscopy; silicone rubber; surface property; swine

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.

在乳房假体周围形成的纤维胶囊的收缩 仍然是乳房重建程序的最常见并发症。 该第二阶段项目的目的是发展表面 修改乳房假体，以改善组织键合 硅胶（SR）表面，同时减少炎症，纤维囊 厚度和囊收缩。该研究将结合三个 已证明可以调节这些组织反应的方法：l） 假体的表面孔隙率，2）共价耦合的蛋白质 假体和3）抑制碳水化合物的碳水化合物 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 他将在表面修饰前后进行特性测试。细胞 培养分析将评估每个涂层的体外生物活性性和 灭菌，干燥和储存对涂料的影响。 最后，修改后的假体将皮下植入猪 16周。 组织硬度的临床评估将通过 凹痕传导。将评估植入物周围的组织 在组织学上以键入SR，炎症细胞的存在， 以及胶囊中胶原蛋白的厚度和建筑。 拟议的商业应用：200万美国人有乳房 假体，纤维胶囊的收缩是最常见的 并发症。提出的表面修饰应改善 通过大大减少胶囊的形成来表现乳房假体 和签署。