Smart Sensing Dental Drill

 描述(申请人提供)：临床重要性：2013年，全球共植入近1000万颗牙种植体，其中300万颗发生在美国。到2018年，这些植入物的全球市场预计将增加到40亿至50亿美元的收入，因为牙科植入物制造商瞄准并培训普通牙医(未接受手术培训)来执行这些程序。手术本身需要在下颌或上颌骨(取决于种植体的位置)钻入截骨术，这样种植体就可以安装在颌骨的骨性结构中。创造最初的截骨术的一个重大挑战是确保不会破坏靠近骨骼的关键结构，从而导致严重的术后并发症。临床局限性：外科医生的目标是在不破坏皮质骨的情况下钻入骨髓管，保护关键的邻近解剖结构。对于下颌种植体，内牙槽神经(Ian)沿髓管分布，支配下颌牙齿、嘴唇、牙床和覆盖在下巴上的皮肤。Ian由皮质骨导管保护；如果在钻探过程中被破坏，可能会造成不可逆转的神经损伤。在上颌种植的情况下，皮质骨界面 将上颌骨的髓质骨与上颌窦分开。在这种情况下，皮质骨破裂可能会导致严重的鼻窦并发症。随着越来越多的非专科医生进入牙种植体市场，必须给予额外的指导，以防止这种髓质/皮质界面的破坏。目前，还没有现有的技术可以在钻井过程中提供“实时”指导。建议的解决方案：我们建议使用具有实时电阻抗传感功能的标准牙钻。据报道，皮质骨的电阻抗比髓腔内的松质骨的电阻抗大20多倍。我们假设，记录在钻头顶端的生物阻抗电信号将具有足够的敏感性和特异性，以检测何时接近皮质骨结构(在破裂之前)。具体目标：我们特别建议设计一种定制的高速电阻抗检测电路，该电路将与牙钻接口。阻抗将被记录在钻头的尖端，当皮质结构接近时，将以一组彩色LED、基于LCD的显示器或听觉信号的形式向用户提供实时反馈。我们的目标是确定使用的最佳电阻抗参数，并评估在体外下颌骨和上颌骨中完全整合的原型。未来方向：RyTek Medical是一家为各种临床应用开发生物阻抗传感设备的小公司。这一特定的设备将补充我们现有的努力。到本节目结束时，我们将演示智能传感钻头在体外模型中的功能。这将使我们处于寻求第二阶段资金的位置，以开发更商业化的设备，并在动物模型和人类临床前试验中评估体内功能。这项技术的其他用途可能包括识别牙齿中的裂缝(空气的阻抗比牙齿组织的阻抗大得多)， 识别牙槽骨丢失，或用于骨科钻探应用。

 DESCRIPTION (provided by applicant): Clinical Importance: Almost 10 million dental implants were placed worldwide in 2013, with 3 million of these procedures taking place in the United States. The worldwide market for these implants is expected to increase to $4.0-$5.0 billion in revenue by 2018 as dental implant manufactures target and train general dentists (non-surgically trained) to perform these procedures. The procedure itself requires an osteotomy be drilled into the mandible or maxilla (depending on site of implant) so that the implant can be seated within the boney structures of the jaw. A significant challenge to creating the initial osteotomy is ensuring that no critical structures near to the bone are breached leading to severe post-procedure morbidities. Clinical Limitations: The object of the surgeon is to drill into the bone's medullary canal without breaching the cortical bone protecting critical adjacent anatomic structures. In the case of a mandibular implant, the interior alveolar nerve (IAN) runs along the medullary canal innervating the teeth of the lower jaw, lips, gums, and skin overlying the chin. The IAN is protected by a conduit of cortical bone; if breached during a drilling procedure irreversible nerve injury is possible. In the case of maxillary implants, a cortical bone interface separates the medullary bone of the maxilla from the maxillary sinus. Breaching the cortical bone in this case can lead to severe sinus complications. As more non-specialists enter the market of dental implants, it is imperative that additional guidance is given to prevent a breach of this medullary/cortical interface. Currently, no existing technology is available to provide "rel-time" guidance during drilling. Proposed Solution: We propose to instrument a standard dental drill with real-time electrical impedance sensing capabilities. The electrical impedance of cortica bone is reported to be more than 20 times greater than that of the cancellous bone found within the medullary cavity. We hypothesize that electrical bioimpedance signatures recorded at the tip of the drill bit will be sufficiently sensitive and specific to detect when cortical bone structure are being approached (prior to breaching). Specific Objectives: We specifically propose to design a custom high-speed electrical impedance sensing circuit that will interface to a dental drill. Impedance will be recorded at the tip of the drill bit and real-time feedback in the form of a colored set of LEDs, an LCD-based display, or auditory signal will be provided to the user informing them when cortical structures are approaching. We aim to determine the optimal electrical impedance parameters to use and to evaluate a fully integrated prototype in ex vivo mandibular and maxillary bones. Future Directions: RyTek Medical is a small company developing bioimpedance-sensing devices for a variety of clinical applications. This specific device will compliment our existing efforts. By the end of this program we will have demonstrated that the smart sensing drill is functional in an ex vivo model. This will position us to seek Phase II funding to develop a more commercial-ready device and to evaluate in vivo functionality in an animal model and human pre-clinical trials. Additional uses of this technology might include identifying cracks in teeth (impedance of air is much greater that of dental tissue), identifying alveolar bone loss, or use in orthopedic drilling applications.