Nanotechnology Enabled Temporomandibular Joint(TMJ)Prosthesis

描述(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/或咀嚼肌肉以及邻近组织结构的医学和牙科疾病。对于一些严重的TMJ退行性变的患者，可能需要假体置换。然而，目前的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屑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，可增强TMJ设备中关节部件的附着力和耐磨性。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的全更换TMJ假体。较小尺寸的假体设计将使以单切口植入为目标的微创临床路径成为可能。新的TMJ假体将使用有限元建模和分析来设计，以最大限度地减少基于关节表面使用纳米结构钻石的装置尺寸。原型设计将在TMJ下颌磨损模拟器中进行制造和测试。成功的设计将被用于临床翻译研究，使用的是微型猪动物模型。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翻译来开发。生物医药和风险投资公司对这一第二阶段项目的支持函已经发出，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UAB的一项专利许可(授予Vista Engineering)，该专利涉及这项技术：“金属上超光滑钻石涂层及其用途的工艺”，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全关节置换假体的新设计。具体目标2：制造有希望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 与公共健康相关：我们建议使用纳米技术方法，使用纳米结构的钻石来控制TMJ种植体与周围组织之间的界面，以提高固定、耐久性和骨整合，以获得长期的种植体成功。多达6万美国人将受益于纳米结构钻石-钻石组件，这将有助于缩小植入设备的尺寸，并使临床上能够以较小的侵入性进行关节修复。我们还为纳米技术支持的TMJ假体的商业化提供了一条明确的途径。

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.