Nanotechnology Enabled Temporomandibular Joint (TMJ) Prosthesis

纳米技术支持的颞下颌关节 (TMJ) 假体

• 批准号: 7841025
• 负责人: Raymond G. Thompson
• 金额: $ 1万
• 依托单位: VISTA ENGINEERING, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-06-02 至 2010-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7841025
• 关键词: Adhesions; Affect; Air; Alloys; Applications Grants; Architecture; Arts; Biological; Biomedical Engineering; Brain; Chemical Engineering; Chemicals; Clinical; Cobalt; Collaborations; Collection; Couples; Dental; Deposition; Deterioration; Development; Device Designs; Devices; Diamond; Dimensions; Disease; Ear; Elements; Engineering; Eye; Failure; Fossa; Friction; Grant; Implant; Industry; Joint Prosthesis; Joints; Lead; Legal patent; Licensing; Masticatory muscles; Mechanics; Medical; Metals; Methods; Miniature Swine; Modeling; NIH Program Announcements; Nanotechnology; Nerve; Operative Surgical Procedures; Orthopedics; Osseointegration; Osteolysis; Outcome Study; Pain; Particulate; Pathway interactions; Patients; Performance; Phase; Polyethylenes; Process; Property; Prosthesis; Rattus; Reaction; Recurrence; Replacement Arthroplasty; Research; Resistance; Route; Shapes; Structure; Surface; Symptoms; Technology; Temporomandibular Joint; Temporomandibular Joint Disorders; Testing; Tissues; Titanium; United States; Weight-Bearing state; base; commercial application; commercialization; design; implantable device; implantation; improved; in vivo; nano; nanostructured; novel; public health relevance; response; restoration; sample fixation; scale up; simulation; success; technological innovation; tool; vapor

DESCRIPTION (provided by applicant): Temporomandibular Disorders (TMD) usually 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. In this project, the UAB and Vista Engineering team will develop novel multilayer nanostructured diamond coatings with enhanced adhesion and wear properties for articulation components in TMJ devices. We will also develop commercialization potential through scale-up and TMJ wear testing. 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: Develop nanotechnology for reducing friction and wear on the articulating, load-bearing components of TMJ metallic implants (condyle and fossa) by chemical vapor deposition (CVD) of an ultra-smooth diamond coating having a multilayer structure with alternating nano- and micro-structural layered components. Biaxial flexural, indentation, and perimeter loading mechanical tests of the diamond coatings will be performed to determine forces that cause spallation. We will investigate the pin-on-disk wear-resistance of these ultra-smooth coatings (intended for diamond-on-diamond articulation) as compared to single-layer diamond-on-diamond articulation or to the metal-on-polyethylene or metal-on-metal couples currently used in commercial TMJ devices. In parallel to developing diamond coatings, we will utilize a finite element modeling and analysis (FEM/FEA) approach in order to evaluate shapes, sizes, critical dimensions and biodynamic stability of the final TMJ implant designs. Specific Aim 2: Demonstrate the capability for scale-up using the commercial 30 kW CVD reactor at Vista Engineering. We will design and fabricate TMJ implant devices that have a multilayer nanostructured diamond coating for both condyle and fossa components. In this Phase-I grant, the commercially produced TMJ implant will undergo extensive testing in a TMJ simulator to 1.125 million cycles (approximately the equivalent of 10 years clinical use). The successful outcome of this study will be an improved design for TMJ devices and coatings for hard-on-hard articulation. One benefit of the diamond-on-diamond components will be a reduction in overall device size that will ultimately allow for a clinically less-invasive route to joint restoration and longer implant lifetime in vivo. The TMJ device will result in less long-term wear at articulating surfaces. This project will lead to a phase-II application involving particulate reaction by implantation of articulating wear debris into a rat synovial-like air pouch, followed by implantation of the coated TMJ device into a minipig model. PUBLIC HEALTH RELEVANCE: We propose the use of nanotechnology approaches for controlling interfaces between Temporomandibular Joint (TMJ) implants and the surrounding tissues. It is estimated that more than 10 million people suffer from the TMJ-related disorder symptoms in the Unites States alone. The primary focus of this grant application is to improve the fixation, durability and osseointegration for long-term success of TMJ implants and lower the need for recurrent multiple surgical procedures. Also, development of new nanotechnology tools and methods will lead to a new class of functionalized nanostructured surfaces for titanium and cobalt chrome alloys for use in biomedical implant industry. One benefit of the diamond-diamond components will be reductions in overall device size that will ultimately allow for a clinically less-invasive route to joint restoration and longer implant lifetime in vivo. We also propose a clear pathway for commercialization of the nanotechnology enabled TMJ prosthesis.

描述（由申请人提供）：颞下颌关节紊乱病（TMD）通常代表影响颞下颌关节（TMJ）和/或咀嚼肌以及邻近组织结构的医学和牙科疾病的集合。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。在该项目中，UAB和Vista工程团队将开发新型多层纳米结构金刚石涂层，用于TMJ器械中的关节组件，具有增强的附着力和耐磨性能。我们还将通过扩大规模和TMJ磨损测试开发商业化潜力。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：开发纳米技术，通过化学气相沉积（CVD）具有多层结构的超光滑金刚石涂层，交替纳米和微米结构分层组件，减少TMJ金属植入物（髁和窝）的关节，承重组件的摩擦和磨损。将对金刚石涂层进行双轴弯曲、压痕和周边载荷机械测试，以确定导致飞溅的力。我们将研究这些超光滑涂层（用于金刚石对金刚石关节）与单层金刚石对金刚石关节或目前商业TMJ器械中使用的金属对聚乙烯或金属对金属对的销-盘耐磨性。在开发金刚石涂层的同时，我们将利用有限元建模和分析（FEM/FEA）方法来评估最终TMJ植入物设计的形状、尺寸、关键尺寸和生物动力学稳定性。具体目标2：证明Vista Engineering使用商用30 kW CVD反应器进行规模放大的能力。我们将设计和制造颞下颌关节植入装置，具有多层纳米结构金刚石涂层的髁和窝组件。在第一阶段的授权中，商业生产的TMJ植入物将在TMJ模拟器中进行广泛的测试，达到112.5万次循环（大约相当于10年的临床使用）。 本研究的成功结果将是TMJ器械和硬对硬关节面涂层的改进设计。金刚石对金刚石组件的一个好处是减小了整个器械的尺寸，最终实现了关节修复的临床微创途径和更长的体内植入物寿命。TMJ器械将减少关节面的长期磨损。该项目将导致II期应用，涉及通过将关节磨损碎屑植入大鼠滑膜样气囊中，然后将涂层TMJ器械植入小型猪模型中的颗粒反应。 公共卫生相关性：我们建议使用纳米技术的方法来控制颞下颌关节（TMJ）植入物和周围组织之间的接口。据估计，仅在美国就有超过1000万人患有与TMJ相关的疾病症状。该补助金申请的主要重点是改善TMJ植入物的长期成功的固定，耐用性和骨整合，并降低对复发性多次手术的需求。此外，新的纳米技术工具和方法的发展将导致一类新的功能化纳米结构表面的钛和钴Chrome合金用于生物医学植入物工业。金刚石-金刚石组件的一个受益是减小了整体器械尺寸，最终实现了关节修复的临床微创途径和更长的体内植入物寿命。我们还提出了一个明确的途径，为商业化的纳米技术使颞下颌关节假体。