Improved manufacture of bone transport plates

简介(申请人提供)：美国每年约有3万例口腔癌确诊，其基本治疗方法是手术切除面部软硬组织。肿瘤切除可能与放射治疗相结合，这会损害剩余组织的血管。下颌骨良性肿瘤也可能需要节段性骨切除，因为单纯刮除或病变内切除后局部复发的发生率很高。此外，冲击伤、高冲击性创伤或为治疗慢性下颌骨骨髓炎而反复进行的外科清创术可能会导致节段性骨丢失。手术切除头部和颈部的硬组织和软组织或高冲击性创伤可能会导致主要组织缺失。下颌骨的重建通常涉及骨骼、牙龈和牙齿。目前的下颌骨牵张器是与重建钢板结合使用的，但当重建钢板获得颌骨的轮廓时，牵张器具有线性向量。这些设备还具有有限的分散距离，会产生较短的直骨片段，因此无法通过一次手术来适应大的缺陷。一种坚固的口腔内下颌骨牵张装置(BTRP-01)是利用第一阶段STTR资金建造的，在活体山羊模型中，该装置被证明是机械坚固的，易于放置和使用，并且能够成功地将齿状骨段跨越2 cm的骨间隙。该STTR提案的第一阶段的目标是创建人类下颌骨和该装置的有限元模型，并建立用于人类的能够承受一系列外部机械力的最不健壮的装置形式。我们将安装和测试迷你磨机立式加工中心，用于精密制造不太坚固的设备，并对这些设备进行机械测试，以确认有限元分析的预测。这项建议的目的是创造一种不那么坚固的设备形式，适合在第二阶段用于人类。该建议的关键特征是使用有限元建模来确定设备的最佳尺寸，以及精确制造更小、更紧凑的设备，以改进治疗和提高患者舒适性。在美国，每年约有3万例口腔癌被诊断出来，其基本治疗方法是手术切除面部的硬组织和软组织，导致主要组织缺失。目前的下颌骨牵张器是与重建钢板结合使用的，但当重建钢板获得颌骨的轮廓时，牵张器具有线性向量。在活体山羊模型中，一个坚固的原型下颌骨牵张装置被证明是机械坚固的，易于放置和使用，并能够成功地将齿状骨段跨越2 cm的骨间隙。这一STTR提案第一阶段的目标是确定用于精密制造更小、更紧凑的设备的最佳尺寸，以改善治疗和增强患者舒适性。

DESCRIPTION (provided by applicant): Every year, about thirty thousand cases of oral cancer are diagnosed in the United States; for which the basic treatment is surgical excision of hard and soft tissues of the face. Tumor excision may be combined with radiotherapy, which compromises the vascularity of the remaining tissues. Benign tumors of the mandible may also require segmental bone resection due to high incidence of local recurrence after simple curettage or intra-lesion excision. Furthermore, segmental bone loss may result from blast injuries, high impact trauma, or repeated surgical debridement for treatment of chronic osteomyelitis of the mandible. Surgical excision of hard and soft tissues of the head and neck or high impact trauma can lead to major tissue deficits. Reconstruction of the lower jaw typically involves bone, gingiva, and teeth. Current mandibular distraction devices are used in combination with reconstruction plates, but while the reconstruction plates take the contour of the jaw, the distraction devices have a linear vector. The devices also have a limited distraction distance, producing short segments of straight bone and so cannot accommodate large deficits with a single procedure. A robust prototype intra-oral mandibular distraction device (BTRP-01) was built using Phase I STTR funding, and was shown to be mechanically robust, easy to place and use, and able to successfully transport a dentate bone segment across a 2 cm bony gap in a live goat model. The objective of Phase I of this STTR proposal is to create a Finite Element Model (FEM) of human mandibles and of the device, and establish the least robust form of the device to be used in humans that is able to withstand a range of external mechanical forces. We will install and test a Mini Mill Vertical Machining Center for precision manufacturing of the less robust forms of device, and mechanically test these devices to confirm the predictions of the FEM. The purpose of this proposal is to create a less robust form of the device suitable for use in humans in Phase II. Critical features of this proposal are the use of finite element modeling to determine optimal dimensions of the device, and precision manufacturing of smaller, more compact devices for improved treatment and enhanced patient comfort. Every year, about thirty thousand cases of oral cancer are diagnosed in the United States; for which the basic treatment is surgical excision of hard and soft tissues of the face, leading to major tissue deficits. Current mandibular distraction devices are used in combination with reconstruction plates, but while the reconstruction plates take the contour of the jaw, the distraction devices have a linear vector. A robust prototype intra-oral mandibular distraction device was shown to be mechanically robust, easy to place and use, and able to successfully transport a dentate bone segment across a 2 cm bony gap in a live goat model. The objective of Phase I of this STTR proposal is to determine optimal dimensions for precision manufacturing of smaller, more compact devices for improved treatment and enhanced patient comfort.