Nanotechnology Enabled Temporomandibular Joint(TMJ)Prosthesis

描述（由申请人提供）：颞下颌关节紊乱病（TMD）是一组影响颞下颌关节（TMJ）和/或咀嚼肌以及邻近组织结构的医学和牙科疾病。对于一些严重TMJ退化的患者，可能需要进行假体置换。然而，目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屑导致的植入物和周围组织的退化。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，增强了TMJ器械中关节组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，以实现更小尺寸和更长寿命的新型全关节置换术。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进行设计，以基于在关节面上使用纳米结构金刚石来最小化器械尺寸。原型设计将在TMJ下颌骨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。生物医学和风险投资公司已经为这个第二阶段项目提供了支持信，以支持我们的商业化计划。UAB和Vista工程有着良好的合作记录，最终（向Vista工程）许可了涉及该技术的UAB专利：“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原型假体。具体目标3：根据下颌骨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特定目标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