A new process to improve the mechanical performance of crosslinked UHMWPE injoint replacement prostheses

提高交联 UHMWPE 关节置换假体机械性能的新工艺

• 批准号: 10760837
• 负责人: Anuj Bellare
• 金额: $ 24.18万
• 依托单位: POLYMERIX LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-19 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10760837
• 关键词: Acceleration; Address; Affect; Aging; Antioxidants; Area; Arthritis; Articulation; Clinical; Complication; Conceptions; Crystallization; Data; Degenerative polyarthritis; Development; Diameter; Dimensions; Dislocations; Elderly; Fatigue; Formulation; Fracture; Healthcare; Hip region structure; Ice; Image; Implant; Incidence; Infection; Joint structure of shoulder region; Knee joint; Left; Legal patent; Liquid substance; Mechanics; Molds; Nitrogen; Operative Surgical Procedures; Osteolysis; Patients; Performance; Polyethylenes; Polymers; Population; Procedures; Process; Prosthesis; Publishing; Replacement Arthroplasty; Research; Research Proposals; Resistance; Risk; Roentgen Rays; Second Look Surgery; Stress; Surface; Technology; Testing; Thermal Conductivity; Thick; Thinness; Time; Total Hip Replacement; Translating; Vitamin E; Water; clinical application; cost; crosslink; design; fabrication; femur head; hip replacement arthroplasty; implant design; improved; manufacturing process; mechanical properties; melting; oxidation; preservation; pressure; success; transmission process; ultra-high molecular weight polyethylene

While total joint replacement prostheses have been a great success for over 80 years in providing mobility to patients with osteoarthritis, post-surgery complications like aseptic loosening, dislocation and infections remain as problems, often leading to costly and complicated revision surgery. The objective of this proposal is to address implant dislocation, the second most common complication for total hip replacement surgeries. One solution to reduce the incidence of dislocation is to increase the diameter of the femoral head and accordingly decrease the thickness of the ultra-high molecular weight polyethylene component. The consequences of these design changes are that the larger articular surface area could lead to higher volumetric wear and the thinner polyethylene components are subjected to higher stresses with a greater likelihood for fracture. The highly wear resistant crosslinked polyethylenes introduced in the late 90’s have addressed the issue of wear but these crosslinked materials also have lower mechanical toughness, limiting the use of thinner polyethylene components. To solve this problem, we have developed a patent-protected rapid-pressurization process which has the potential to greatly increase the ductility of crosslinked polyethylene without compromising its strength. We hypothesize that pressure-quenching of antioxidant containing crosslinked polyethylene will exceed the toughness, strength and resistance to fatigue crack propagation over uncrosslinked polyethylene without compromising wear or oxidation resistance. Our preliminary data on pressure quenching and past research on thermal quenching show that a pseudo-hydrostatic process in which the melted, crosslinked polyethylene is rapidly pressurized and crystallized can be performed on large cylinders using a simple hydraulic press, which is easily translatable into a manufacturing process, providing bulk crosslinked polyethylene from which implants can be machined. The specific aims of the proposal are: Aim 1 will optimize the pressure-quenching process of Vitamin E containing crosslinked polyethylene and verify its superior mechanical properties using tensile, fracture toughness and impact tests. Aim 2 will use accelerating aging to demonstrate that the pressure-quenched Vitamin E containing crosslinked polyethylene is oxidation-resistant. Aim 3 will include long-term wear and fatigue crack propagation tests to verify that pressure-quenched, Vitamin E containing crosslinked polyethylene preserves wear resistance and has a higher resistance to fatigue crack propagation. This proposal has the potential to guide in the fabrication of total hip replacement components which are less likely to dislocate, without compromising either wear resistance or risk for mechanical damage. Furthermore, knee and shoulder joint components, which are subjected to higher stresses could be better protected from mechanical damage. The long-term plan is to leverage this materials-formulation study to investigate implant designs in a larger project that can reduce the incidence of dislocation without compromising either wear or mechanical damage. Longer lasting joint replacements would greatly benefit the elderly with osteoarthritis who require these implants for mobility.

虽然总体替代假体的总替代假体在80多年来都取得了巨大的成功，以提供机动性 骨关节炎，手术后并发症（例如无菌松动，脱位和感染）的患者仍然存在 作为问题，通常会导致昂贵且复杂的修订手术。该提议的目的是 解决植入物脱位，这是全髋关节置换手术的第二常见并发症。一 减少脱位发生率的解决方案是增加股骨头的直径 减小超高分子量聚乙烯成分的厚度。后果 这些设计变化是，较大的关节表面积可能会导致更高的体积磨损，并且 较薄的聚乙烯成分会承受较高的应力，其骨折可能性更大。 90年代后期引入的高度耐磨性交联聚乙烯已经解决了磨损问题 但是这些交联材料也具有较低的机械韧性，限制了使用较薄的聚乙烯的使用 成分。为了解决这个问题，我们开发了一个专利保护的快速压力过程 有可能大大提高交联聚乙烯的延展性，而不会损害其强度。 我们假设含有交联聚乙烯的抗氧化剂的压力将超过 韧性，强度和抗疲劳裂纹在无连接聚乙烯上的疲劳性传播 损害磨损或氧化抗性。我们有关压力淬火和过去研究的初步数据 热淬灭表明，熔化的，交联的聚乙烯为伪静态过程 可以使用简单的Hydroulic按压在大缸上进行迅速加压和结晶 很容易翻译成制造过程，提供大量的交联聚乙烯 植入物可以加工。该提案的具体目的是：AIM 1将优化压力压力 维生素E含有交联的聚乙烯的过程，并使用其优质的机械性能验证 拉伸，断裂韧性和冲击测试。 AIM 2将使用加速衰老来证明 含有压力的维生素E含有交联的聚乙烯具有氧化抗性。 AIM 3将包括 长期磨损和疲劳裂纹传播测试，以验证含有压力的维生素E 交联的聚乙烯固定耐耐受性，并且对疲劳裂纹繁殖具有更高的抗性。 该提案有可能指导制造总髋关节置换组件，这些组件较少 可能会脱位，而不会损害耐磨性或机械损伤的风险。此外， 受到更高压力的膝盖和肩关节成分可以更好地保护 机械损坏。长期计划是利用这项材料制定研究来研究植入物 在一个较大的项目中的设计，该项目可以减少脱位事件而不会损害磨损或 机械损坏。更长的持久关节替代物将通过骨关节炎极大地使人受益匪浅 需要这些即将流动。