Improved manufacture of bone transport plates

描述（由申请人提供）：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软硬组织。肿瘤切除可联合放射治疗，这损害了剩余组织的血管。由于单纯刮除或病灶内切除后局部复发率高，下颌骨良性肿瘤也可能需要节段性骨切除术。此外，节段性骨丢失可能由爆炸伤、高冲击力创伤或治疗下颌骨慢性骨髓炎的反复手术清创引起。头颈部硬组织和软组织的手术切除或高冲击创伤可导致严重的组织缺损。下颌的重建通常包括骨、牙龈和牙齿。目前的下颌牵引装置与重建板联合使用，但重建板采用下颌轮廓，而牵引装置具有线性矢量。该装置的牵引距离也有限，只能产生短段直骨，因此不能一次手术就适应较大的缺损。使用第一阶段STTR资金建造了一个坚固的口腔内下颌牵引装置原型（BTRP-01），并证明其机械坚固，易于放置和使用，并且能够在活山羊模型中成功地将齿状骨段运输过2厘米的骨间隙。本STTR提案第一阶段的目标是创建人类下颌骨和设备的有限元模型（FEM），并建立用于人类的设备的最小鲁棒形式，该设备能够承受一系列外部机械力。我们将安装和测试一个迷你铣床立式加工中心，以精确制造不太坚固的设备形式，并对这些设备进行机械测试，以证实FEM的预测。本提案的目的是创建一种适合于II期人类使用的不太坚固的设备形式。该建议的关键特点是使用有限元建模来确定设备的最佳尺寸，并精确制造更小，更紧凑的设备，以改善治疗和提高患者舒适度。在美国，每年大约有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，导致严重的组织缺损。目前的下颌牵引装置与重建板联合使用，但重建板采用下颌轮廓，而牵引装置具有线性矢量。一种坚固耐用的口腔内下颌牵引装置原型在山羊活体模型中具有机械坚固性，易于放置和使用，并且能够成功地将齿状骨段运输过2厘米的骨间隙。该STTR提案第一阶段的目标是确定更小、更紧凑的设备精密制造的最佳尺寸，以改善治疗和提高患者舒适度。

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.