Arthroscopic rotator cuff repair device

关节镜肩袖修复装置

• 批准号: 7051604
• 负责人: Simon Williams
• 金额: $ 10万
• 依托单位: TEPHA, INC.
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-08-10 至 2007-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7051604
• 关键词: biomaterials; bone; injury; tear; tendons; tissues

DESCRIPTION (provided by applicant): The objective of this research is to determine the feasibility of developing a new device for rotator cuff repair that can be used in an arthroscopic procedure. The product is expected to reduce the incidence of re-tears following arthroscopic rotator cuff repair, and to potentially allow a more aggressive rehabilitation, particularly for younger patients. This new device is expected to be used as either an augmentation patch or as an interposition graft, in both acute and chronic rotator cuff repairs. It is estimated that there are now over 250,000 rotator cuff repairs performed each year in the United States, and most of these surgeries are now performed arthroscopically. Yet there is currently no device designed for use in an arthroscopic procedure. The research approach will employ a new absorbable biomaterial, known as TephaFLEX(tm) biomaterial (poly-4-hydroxybutyrate), that has been shown to have high initial strength and prolonged strength retention in vivo, as well as a capacity to remodel in vivo into new tissue. The specific aims of the project are: (1) to produce TephaFLEX(tm) biomaterial in a form suitable for extrusion into multifilament fiber, and to knit the fiber into a mesh scaffold that can be deployed through an arthroscope, resulting in a device with an initial burst strength comparable to current devices used for rotator cuff repair; (2) to test the mesh in vitro to confirm sterility and a lack of cytotoxicity, and (3) implant the mesh scaffold in a small animal model of rotator cuff injury to demonstrate that, after 12 weeks' time, the strength of a repair using this augmentation and/or an interposition scaffold is stronger than that with no such device; and to perform a morphological and histological study on the scaffold explants to assess any inflammatory reaction, appropriate tissue in-growth, and overall suitability of such a scaffold for use in rotator cuff repair. In addition to developing a product that could improve surgical outcomes of rotator cuff repair, this research will also help to introduce a new absorbable medical biomaterial to the medical community that could find additional uses, for example, in other medical devices, in tissue-engineering applications, and for controlled-release drug delivery.

描述（由申请人提供）：本研究的目的是确定开发一种可用于关节镜手术的肩袖修复新装置的可行性。该产品有望减少关节镜下肩袖修复后再撕裂的发生率，并有可能实现更积极的康复，特别是对年轻患者。这种新装置有望在急性和慢性肩袖修复中用作增强贴片或插入移植物。据估计，现在在美国每年有超过25万例肩袖修复手术，其中大多数手术都是关节镜下进行的。然而，目前还没有设计用于关节镜手术的设备。该研究方法将采用一种新的可吸收生物材料，称为TephaFLEX（tm）生物材料（聚4-羟基丁酸酯），该材料已被证明具有高初始强度和长时间的体内强度保留，以及在体内重塑成新组织的能力。该项目的具体目标是：(1)以适合挤压成多丝纤维的形式生产TephaFLEX（tm）生物材料，并将纤维编织成可通过关节镜展开的网状支架，从而产生具有可与当前用于肩袖修复的设备相媲美的初始爆裂强度的设备；(2)在体外测试网状支架，以确认其无菌性和缺乏细胞毒性；(3)将网状支架植入旋转袖损伤的小动物模型中，以证明在12周后，使用这种增强支架和/或插入支架的修复强度比不使用这种装置的修复强度更强；并对支架外植体进行形态学和组织学研究，以评估任何炎症反应，适当的组织生长，以及这种支架用于肩袖修复的整体适用性。除了开发一种可以改善肩袖修复手术效果的产品外，这项研究还将有助于向医学界介绍一种新的可吸收医学生物材料，这种材料可以找到其他用途，例如，在其他医疗设备、组织工程应用和控释药物输送中。