Improved manufacture of bone transport plates

描述（申请人提供）：美国每年约有3万例口腔癌确诊病例，其基本治疗方法是手术切除面部硬组织和软组织。肿瘤切除可以与放射治疗相结合，这会损害剩余组织的血管分布。下颌骨的良性肿瘤也可能需要节段性骨切除，因为在简单刮除或病灶内切除后局部复发的发生率很高。此外，部分骨丢失可能是由于爆炸伤、高冲击力创伤或用于治疗下颌骨慢性骨髓炎的反复手术清创。头颈部硬组织和软组织的手术切除或高冲击创伤可导致主要组织缺损。下颌骨的重建通常涉及骨骼，牙龈和牙齿。当前的下颌骨牵引装置与重建板组合使用，但是当重建板采用颌的轮廓时，牵引装置具有线性矢量。这些器械的牵引距离也有限，产生的直骨节段较短，因此无法通过一次手术适应较大的缺损。一个强大的原型口内下颌骨牵引装置（BTRP-01）是使用第一阶段STTR资金，并被证明是机械坚固，易于放置和使用，并能够成功地运输齿状骨段通过2厘米的骨间隙在活山羊模型。本STTR提案第I阶段的目标是创建人体下颌骨和器械的有限元模型（FEM），并确定用于人体的器械的最不坚固形式，该形式能够承受一定范围的外部机械力。我们将安装和测试一台小型立式加工中心，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FEM的预测。本提案的目的是创建一种不太耐用的器械形式，适用于II期人体。该提案的关键特征是使用有限元建模来确定器械的最佳尺寸，以及精确制造更小、更紧凑的器械，以改善治疗并提高患者舒适度。在美国，每年大约有三万例口腔癌被诊断出来;对于这些口腔癌，基本的治疗方法是手术切除面部的硬组织和软组织，导致主要的组织缺损。当前的下颌骨牵引装置与重建板组合使用，但是当重建板采用颌的轮廓时，牵引装置具有线性矢量。一个强大的原型口内下颌骨牵引装置被证明是机械坚固，易于放置和使用，并能够成功地运输齿状骨段通过2厘米的骨间隙在活山羊模型。本STTR提案第I阶段的目标是确定更小、更紧凑器械的精确制造的最佳尺寸，以改善治疗并提高患者舒适度。

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.