Nanotechnology Enabled Temporomandibular Joint(TMJ)Prosthesis

描述（由申请人提供）：颞下颌疾病（TMD）是影响颞下颌关节（TMJ）和/或咀嚼肌肉以及相邻组织结构的一系列医学和牙科疾病。对于一些严重TMJ退变的患者，可能需要更换假体。然而，目前种植体设计的长期成功和功能仍然是一个严重的问题，很大程度上是由于磨损碎片导致种植体和周围组织的恶化。在该项目的第一阶段，UAB和Vista工程团队开发了新型纳米金刚石涂层，增强了TMJ设备中关节部件的附着力和磨损性能。这项新技术将用于拟议的第二阶段，使新的全置换TMJ假体尺寸更小，寿命更长。较小尺寸的假体设计将实现针对单切口植入的微创临床路径。新的TMJ假体将使用有限元建模和分析来设计，以在关节表面使用纳米结构金刚石来最小化设备尺寸。原型设计将在下颌磨损模拟器中制造和测试。成功的设计将使用微型猪动物模型进行临床翻译研究。该产品的商业化潜力将通过假肢设计、原型磨损测试和临床翻译来开发。生物医学和风险投资公司已经为这个二期项目提供了支持信，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（向Vista Engineering）授权了一项涉及该技术的UAB专利：“金属超光滑金刚石涂层工艺及其用途”，专利# 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TMJ全置换术假体的新设计。具体目标2：制造有前途的微创设计原型假肢。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序和修改具体目标4：对两种最有前途的设计进行临床翻译研究

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 PUBLIC HEALTH RELEVANCE: We propose the use of a nanotechnology approach, using nanostructured diamond for controlling interfaces between Temporomandibular Joint (TMJ) implants and the surrounding tissues, to improve the fixation, durability and osseointegration for long-term implant success. As many as 60,000 Americans could benefit from the nanostructured diamond-diamond components that will facilitate reductions in implant device size and enable a clinically less- invasive route to joint restoration. We also propose a clear pathway for commercialization of the nanotechnology enabled TMJ prosthesis.