Nanotechnology Enabled Temporomandibular Joint(TMJ)Prosthesis

描述（由申请人提供）：颞下颌疾病（TMD）代表影响颞下颌关节（TMJ）和/或咀嚼肌肉以及邻近组织结构的一系列医疗和牙科疾病。对于一些患有严重颞下颌关节退化的患者，可能需要更换假体。然而，当前植入物设计的长期成功和功能仍然是一个严重的问题，这在很大程度上是由于磨损碎片导致植入物和周围组织的恶化。在该项目的第一阶段，UAB 和 Vista 工程团队开发了新型纳米技术金刚石涂层，为 TMJ 装置中的关节部件增强了粘附性和耐磨性。这项新技术将用于拟议的第二阶段，以实现尺寸更小、寿命更长的新型全替代颞下颌关节假体。较小尺寸的假体设计将使针对单切口植入的微创临床路径成为可能。新的颞下颌关节假体将使用有限元建模和分析进行设计，以在关节表面使用纳米结构金刚石的基础上最大限度地减小装置尺寸。原型设计将在 TMJ（下颌磨损模拟器）中制造和测试。成功的设计将使用小型猪动物模型进行临床转化研究。该产品的商业化潜力将通过假体设计、原型磨损测试和临床转化来开发。该二期项目的支持信来自生物医学和风险投资公司，以支持我们的商业化计划。 UAB 和 Vista Engineering 有着良好的合作记录，最终获得了一项涉及该技术的 UAB 专利授权（授予 Vista Engineering）：“金属上超光滑金刚石涂层的工艺及其用途”，专利号 6,183,818。我们的具体目标如下： 具体目标1：通过计算机建模和分析优化微创颞下颌关节全置换假体的新设计。具体目标 2：制造有前途的微创设计的原型假体。具体目标 3：根据下颌磨损模拟器的测试结果对计算机优化设计进行排名和修改 具体目标 4：对两种最有前途的设计进行临床转化研究

DESCRIPTION (provided by applicant): Temporomandibular Disorders (TMD) represent a collection of medical and dental conditions affecting the temporomandibular joint (TMJ) and/or the muscles of mastication, as well as contiguous tissue structures. For some patients with severe TMJ degeneration, a prosthetic replacement may be required. However, long-term success and functioning of current implant designs remains a serious problem due, in large part, to the deterioration of the implant and surrounding tissue resulting from wear debris. During Phase I of this project, the UAB and Vista Engineering team developed novel nanotechnology diamond coatings with enhanced adhesion and wear properties for articulation components in TMJ devices. This new technology will be used in the proposed Phase II to enable new total replacement TMJ prostheses of smaller size and longer life. The smaller sized prosthesis designs will enable minimally invasive clinical pathways targeted for a single-incision implantation. The new TMJ prostheses will be designed using finite element modeling and analysis to minimize the device size based on the use of nanostructured diamond on the articulating surfaces. The prototype designs will be manufactured and tested in a TMJ, mandibular wear simulator. Successful designs will be carried to clinical translation studies using a miniature pig animal model. Commercialization potential for the product will be developed through prosthesis design, prototype wear testing and clinical translation. Letters of support for this Phase II project have come from biomedical and venture capital companies in support of our commercialization plan. UAB and Vista Engineering have a strong track record of collaboration culminating in the licensing (to Vista Engineering) of a UAB patent involving this technology: "Process for Ultra Smooth Diamond Coating on Metals and Uses Thereof", Patent # 6,183,818. Our specific aims are as follows: Specific Aim 1: Optimize New Designs for Minimally Invasive TMJ Total Replacement Prosthesis by Computer Modeling and Analysis. Specific Aim 2: Manufacture Prototype Prostheses of Promising Minimally Invasive Designs. Specific Aim 3: Rank and Revise Computer-Optimized Designs Based on Test Results from Mandibular Wear Simulator Specific Aim 4: Conduct Clinical Translation Studies on Two Most Promising Designs