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.

乳房假体周围形成的纤维囊收缩 仍然是乳房重建手术最常见的并发症。 该二期项目的目标是开发表面组合 对乳房假体进行改造，以改善组织粘合 硅胶 (SR) 表面，同时减少炎症、纤维囊 厚度和囊膜收缩。该研究将结合三 已被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) 与假体共价偶联的蛋白质 假体，以及 3) 应用于假体顶部的抑制纤维化的碳水化合物 蛋白质涂层。涂层假体的表面特性 将分析材料的涂层均匀性和机械性能 将在表面改性之前和之后测试性能。细胞 培养测定将评估每种涂层的体外生物活性 灭菌、干燥和储存对涂层的影响。 最后，改良后的假肢将被植入猪皮下 16 周。 组织硬度的临床评估将通过以下方式进行评估 压痕眼压计。将评估植入物周围的组织 组织学上与 SR 的结合，炎症细胞的存在， 以及胶囊中胶原蛋白的厚度和结构。 拟议的商业应用：200 万美国人拥有乳房 假体，其中纤维囊收缩是最常见的 并发症。所提议的表面修饰应改善 通过大大减少胶囊形成来提高乳房假体的性能 和挛缩。