Noninvasive Dental Implant Imaging System

描述（由申请人提供）：牙科植入物具有非常高的存活率，是牙科中增长最快的领域。但是，高并发症发生率导致显著的发病率、成本和失望。术前更好地了解软组织厚度和硬组织轮廓可以显著降低并发症发生率。目前用于植入手术的软组织厚度测量技术涉及用探针或射线照相术对精细组织的某种程度上不准确的机械穿透，这对于软组织测量不是最佳的。提出了一种非侵入性超声成像系统，其可以通过以下方式潜在地改进植入手术：对软组织厚度（包括移植物）进行准确的非侵入性术前测量;识别重要的表面骨特征（诸如孔）;在拔牙之前识别牙齿上的骨缺损或开裂，或者在放置植入物之后识别牙齿上的骨缺损或开裂;如果皮质骨缺损或开裂，则促进初始钻孔的术中重定向。 穿孔发生;以及通过测量覆盖的软组织精确定位埋入的愈合植入物。超声波非常适合这一目的，因为：它可以在手术前或手术期间实时使用;数据位于患者成像的确切部位，由牙医直接查看;它是非侵入性的，没有电离辐射;并且可以用便宜的便携式仪器进行。 如果成功的话，超声系统有望通过减少手术、美学和假体并发症所需的昂贵的预防性手术来降低植入治疗的整体社会成本。此外，该系统将提高常规种植体结果的质量和可预测性（特别是促进微创无翻瓣手术）-对牙医和患者都很重要。 该阶段II SBIR工作的目的是证明定制的非侵入性超声成像系统ImSight用于牙科种植手术的临床疗效。该提案将专注于定制ImSight探针的制造，体外学习研究，探针实施例的体外优化研究，临床试验和ImSight设备的监管测试。该系统将用于牙科种植体手术植入前、手术植入期间、后续手术展开期间的治疗计划，以及长期监测。

DESCRIPTION (provided by applicant): Dental implants have very high survival rates and are the fastest growing field in dentistry. But, high complication rates result in significant morbidit, cost, and disappointment. Better pre-operative knowledge of soft tissue thickness and hard tissue contour could dramatically cut complication rates. Current soft tissue thickness measurement techniques for implant procedures involve somewhat inaccurate mechanical penetration of delicate tissues with probes or radiography which is not optimal for soft tissue measurement. A noninvasive ultrasound imaging system is proposed that can potentially improve implant procedures by enabling: accurate non-invasive preoperative measurement of soft tissue thickness, including grafts; identification of important surface bony features such as foramina; identification of bony defects or dehiscences on teeth before extraction, or implants after placement; facilitate intra-operative redirection of the initial drill should a cortical bony perforation occur; and precise location of buried healing implants with measurement of overlying soft tissue. Ultrasound is ideally suited to this purpose because: it can be used in real-time before or during surgeries; data is located to the exact site being imaged on the patient, as directly viewed by the dentist; it is non-invasive and without ionizing radiation; and it can be performed with an inexpensive portable instrument. If successful, the ultrasound system is expected to lower the overall societal cost of implant therapy by decreasing the need for expensive adjunctive procedures necessitated by surgical, esthetic and prosthetic complications. Additionally, the system will improve the quality and predictability of routine implant outcomes (especially facilitating minimally invasive flapless surgery) - important to both dentists and patients. The objective of this Phase II SBIR effort is to demonstrate the clinical efficacy of a customized noninvasive ultrasound imaging system, ImSight, for dental implant procedures. The proposal will focus on fabrication of customized ImSight probes, in-vitro learning studies, in-vitro optimization studies of probe embodiments, clinical trials, and regulatory testing of the ImSight device. The system will be used for treatment planning prior to surgical placement of dental implants, during surgical implant placement, during their subsequent surgical uncovery, and for long-term monitoring.