Optimization of a Novel Thread Geometry for Various Orthopedic Surgery Applications

适用于各种骨科手术应用的新型螺纹几何形状的优化

• 批准号: 10491290
• 负责人: Andrew Ray Fauth
• 金额: $ 21.05万
• 依托单位: OSTEOCENTRIC TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-20 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10491290
• 关键词: Activities of Daily Living; Anatomy; Animal Model; Animals; Architecture; Area; Bone Screws; Businesses; Case Series; Clinical; Clinical Research; Data; Data Element; Defect; Development; Education; Elements; Equipment; Face; Failure; Fatigue; Finite Element Analysis; Fracture; Future; Geometry; Goals; Healthcare Systems; Histology; Human; Image; Implant; Israel; Lead; Life; Manufacturer; Marketing; Mechanics; Medical center; Methodology; Methods; Modeling; Orthopedic Surgery; Orthopedics; Osseointegration; Osteoporotic; Outcome; Outsourcing; Patient Care; Patients; Performance; Phase; Postoperative Complications; Process; Production; Radial; Resistance; Resolution; Risk; Sheep; Small Business Innovation Research Grant; Source; Stress; Study models; Surface; Technology; Testing; Torque; Translating; Trauma patient; Weight-Bearing state; Width; X-Ray Computed Tomography; austin; bone; bone geometry; bone preservation; bone quality; clinical application; commercialization; cost; cost effective; cost effectiveness; design; efficacy evaluation; healing; improved; innovation; long bone; manufacture; novel; osteoporotic bone; prevent; prototype; research and development; safety and feasibility; sample fixation; success; tool

PROJECT SUMMARY/ABSTRACT The majority of threaded interfaces (screws) used in orthopaedics utilize a buttress thread design which has limitations in clinical application. Clinically, orthopaedic screws must resist the dynamic forces generated during common activities of daily living, yet buttress screws are not designed to resist multidirectional force, leading to increased risk of postoperative complications including screw loosening and failure of fixation. Since the modifiable variables of buttress screw designs—including thread pitch, depth, width and face angle—are interrelated, attempts to improve screw functionality by altering these variables is limited. The challenge in bone threaded surface interface is in the optimization of threaded surfaces that meet the loading scenarios at different anatomic sites with varying bone stock, more often than not, one of poor bone quality. The development of innovative bone-screw-fastener technologies for the field of orthopaedic surgery is the underlying focus of OsteoCentric, Inc., a small business based in Austin, TX. The company has designed, manufactured and implemented a new bone-screw-fastener design, the Bone Interlocking Thread Geometry (BITG), based on a technology that creates a circumferential interlocking interface that maximizes bone volume and preserves bone architecture. The BITG overcomes many of the limitations of buttress screws by resisting multidirectional forces and bending moments, minimizing radial forces, and allowing for higher finishing torques. These enhancements can prevent fixation construct failure especially with cases with inadequate bone quality. We have successfully developed and validated bone-thread-interface Finite Element (FE) models for three loading conditions and have conducted a parametric FE analysis to optimize the BITG thread pitch geometry. The SBIR Phase II proposal seeks to build on our early success by optimizing the thread geometry; testing it in a large animal model; and optimizing the BITG thread manufacturing methodology. This will enable OsteoCentric to market a clinically superior product that reduces the overall cost of implants to the healthcare system by utilizing more cost-effective non-locking screws and plates. The specific aims of the Phase II are: Specific Aim 1: Conduct a comprehensive parametric analysis of the BITG using validated FE analysis to optimize cortical and cancellous thread geometry for normal and osteoporotic bones. Specific Aim 2: Optimize methods of BITG manufacturing to enhance cost-effectiveness and efficiency; build internal prototyping and manufacturing expertise; and build an education package for outsource production manufacturers to streamline BITG technology production. Specific Aim 3: Test the optimized BITG thread design against traditional buttress screw using an ovine fracture model in both normal and osteoporotic conditions.

项目摘要/摘要 骨科中使用的大多数螺纹接口(螺丝)采用支撑式螺纹设计，该设计具有 临床应用的局限性。临床上，矫形螺丝钉必须抵抗在手术过程中产生的动态力 日常生活中常见的活动，然而支撑螺丝的设计不能抵抗多向力，导致 增加术后并发症的风险，包括螺钉松动和固定失败。自.以来 支撑螺杆设计的可修改变量--包括螺距、深度、宽度和面角--是 相互关联的，通过改变这些变量来改善螺钉功能的尝试是有限的。骨骼方面的挑战 螺纹面界面是在优化螺纹面的情况下，满足不同的加载场景 解剖部位有不同的骨量，往往是骨质量较差的部位。 骨科外科领域创新的骨螺丝紧固件技术的发展是 OsteoCentric，Inc.是一家总部位于德克萨斯州奥斯汀的小企业。该公司设计了， 制造并实施了一种新的骨螺丝紧固件设计--骨锁紧螺纹几何 (BITG)，基于一种创建最大骨量的周向联锁界面的技术 并保存了骨骼结构。BITG克服了支撑螺丝的许多局限性，通过抵抗 多向力和弯矩，最小化径向力，并允许更高的精加工扭矩。 这些增强可以防止固定构造失败，特别是在骨质量不佳的情况下。 我们已经成功地开发并验证了三个骨-线-界面有限元模型 并进行了参数有限元分析，以优化BITG螺距几何形状。 SBIR第二阶段提案寻求通过优化线程几何结构来建立我们早期的成功基础；在 大型动物模型；以及优化BITG线制造方法。这将启用OsteoCentric 销售一种临床上优越的产品，通过以下方式降低医疗系统植入物的总成本 使用更具成本效益的非锁定螺钉和板材。第二阶段的具体目标是：具体目标 1：使用经过验证的有限元分析对BITG进行全面的参数分析，以优化皮质 以及正常和骨质疏松骨骼的松质线几何形状。具体目标2：优化BITG方法 制造以提高成本效益和效率；建立内部原型和制造 专业知识；并为外包生产制造商建立培训包，以简化BITG 技术生产。具体目标3：将优化后的BITG螺纹设计与传统的支撑螺丝进行对比测试 在正常和骨质疏松条件下使用绵羊骨折模型。