Compliant Shape Memory Polymer Device for Meniscal Repair

用于半月板修复的顺应性形状记忆聚合物装置

• 批准号: 8199457
• 负责人: Kathryn Elizabeth Smith
• 金额: $ 15万
• 依托单位: MEDSHAPE SOLUTIONS, INC.
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-01 至 2012-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8199457
• 关键词: Address; Affect; Arthritis; Biomechanics; Caliber; Cattle; Characteristics; Clinical; Compressive Strength; Device Designs; Devices; Environment; Failure; Generations; Goals; Healed; Hybrids; Implant; In Vitro; Knowledge; Length; Measures; Mechanics; Memory; Meniscus structure of joint; Modeling; Orthopedic Procedures; Patients; Performance; Phase; Physiological; Polymers; Procedures; Process; Property; Recovery; Reporting; Research; Shapes; Site; Small Business Innovation Research Grant; Solutions; Stimulus; Stress; Structure; Surgical sutures; Techniques; Testing; Tissue Fixation; Tissues; United States; Wound Healing; base; cost; design; flexibility; functional outcomes; healing; implantation; improved; instrument; novel; prototype; repaired; sample fixation; soft tissue; stem; success; technological innovation

DESCRIPTION (provided by applicant): The objective of this project is to develop compliant meniscal repair devices based on shape memory polymers. The repair device will be inserted in a less invasive temporary shape and then triggered to expand into its permanent functional shape. Meniscus repair represents an increasingly common and critical soft-tissue based orthopedic procedure. Approximately 900,000 procedures are performed annually in the United States at an estimated cost of over $86 million. Fixation devices, such as sutures, tacks, and hybrid devices, are commonly used in meniscus repair procedures to help facilitate tissue healing. The requirements of minimal invasion and appropriate biomechanical properties are often mutually exclusive with devices comprised of static materials. The most common reported failures of current meniscal repair devices include device misplacement and breakage, compliance mismatch with meniscus tissue, inflammation of joint cavity, and chondral damage. The proposed shape memory meniscal repair device collectively addresses the primary clinical issues associated with both rigid tacks and suture-based devices used in meniscal repair procedures. The device will be inserted in a thin shape to allow for easy insertion and minimal tissue damage. Specific geometric design features will be included on both ends of the device to provide fixation within the torn tissue ends. Using the shape memory characteristics of the device material, the device will be triggered to expand across the tear site AND compress the two torn tissue ends together to provide complete tissue-to-tissue contact for enhanced healing. By tailoring the geometry of the device, the compliance of the device will be more closely aligned to native meniscus tissue such that the biomechanics of the meniscus are not drastically altered. This proposed project will be accomplished through two specific Aims. Aim 1 will involve understanding how device geometry impacts device compliance and shape memory recovery characteristics. Aim 2 will focus on developing prototypes and testing their functional performance in an in vitro benchtop model. The successful completion of the Phase I will demonstrate overall proof of concept for compliant shape memory repair devices as well as provide the fundamental knowledge needed to develop successful commercial devices. PUBLIC HEALTH RELEVANCE: This project can impact the estimated 900,000 patients who undergo meniscus repair annually in the United States. The goal of this project is to develop compliant shape memory repair devices that will improve the functional outcome for patients with torn menisci by offering a less invasive approach and more reliable healing.

描述(由申请人提供)：该项目的目标是开发基于形状记忆聚合物的顺应性半月板修复装置。修复装置将被插入侵入性较小的临时形状，然后被触发以扩展成其永久功能形状。半月板修复是一种越来越常见和关键的软组织矫形手术。在美国，每年约有90万例手术，估计费用超过8600万美元。固定装置，如缝合线、钉子和混合装置，通常用于半月板修复程序，以帮助促进组织愈合。微创和适当的生物力学性能的要求通常与由静态材料组成的装置相互排斥。目前报道的半月板修复装置最常见的故障包括装置错位和断裂、与半月板组织顺应性不匹配、关节腔炎症和软骨损伤。拟议的形状记忆半月板修复装置共同解决了半月板修复程序中使用的刚性钉子和基于缝线的装置所涉及的主要临床问题。该装置将以薄的形状插入，以便于插入并将组织损伤降至最低。该装置的两端将包括特定的几何设计特征，以在撕裂的组织末端提供固定。利用装置材料的形状记忆特性，装置将被触发以在撕裂部位扩展，并将撕裂的两个组织末端压缩在一起，以提供完整的组织与组织之间的接触，从而增强愈合。通过调整装置的几何形状，装置的顺应性将与自然半月板组织更紧密地对准，从而使半月板的生物力学不会发生剧烈变化。这个拟议的项目将通过两个具体目标来实现。目标1将涉及了解设备几何结构如何影响设备合规性和形状记忆恢复特性。目标2将专注于开发原型，并在体外台式模型中测试其功能性能。第一阶段的成功完成将展示符合要求的形状记忆修复设备的总体概念验证，并提供开发成功的商业设备所需的基本知识。 公共卫生相关性：该项目可能会影响美国每年接受半月板修复的大约90万名患者。该项目的目标是开发符合要求的形状记忆修复设备，通过提供一种侵入性更小的方法和更可靠的愈合来改善半月板撕裂患者的功能结果。