Arthroscopic rotator cuff repair device

描述(由申请人提供)：这项研究的目的是确定开发一种可用于关节镜手术的新的肩袖修复装置的可行性。该产品有望减少关节镜下肩袖修复后再撕裂的发生率，并可能允许更积极的康复，特别是对年轻患者。这一新装置有望在急慢性肩袖修复中用作增强补片或间置移植物。据估计，现在美国每年进行的肩袖修复手术超过25万例，其中大部分手术现在都是在关节镜下进行的。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)，这种材料已被证明具有高初始强度和在体内长期保持强度的能力，以及在体内重新塑造成新组织的能力。该项目的具体目标是：(1)生产适合挤压成复丝纤维的TephaFLEX(Tm)生物材料，并将该纤维编织成可通过关节镜展开的网状支架，从而产生一种初始爆炸强度可与目前用于肩袖修复的装置相媲美的装置；(2)体外测试网状支架，以确认无菌和无细胞毒性；(3)将网状支架植入小动物肩袖损伤模型中，以证明12周后，使用这种增强和/或间置支架的修复强度比没有使用这种装置的修复强度更强；以及对支架植块进行形态学和组织学研究，以评估任何炎症反应、合适的组织生长，以及这种支架用于肩袖修复的总体适宜性。除了开发一种可以改善肩袖修复手术结果的产品外，这项研究还将有助于向医学界介绍一种新的可吸收医用生物材料，这种材料可能会在其他医疗设备、组织工程应用和控释药物输送中找到其他用途。

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.