SBIR Phase I: Miniaturization of a Magnetic Craniofacial Distraction System

这个小型企业创新研究(SBIR)第一阶段项目的更广泛的影响/商业潜力是改善全球每年超过20万名新生儿的手术结果，这些新生儿出生时患有导致头骨或下颌发育障碍的先天性疾病。这些异常影响呼吸、听力、言语、视觉功能、神经发育和咀嚼。目前对这一脆弱群体的治疗本身就是复杂和创伤的。牵引成骨(DO)是一种被广泛认可的治疗颅面畸形的方法，它利用人体天然的再生骨能力来纠正骨骼缺陷和缺陷。虽然外科医生已经证明了DO在修复先天颅面差异患者的功能差异方面的实用性，但由于目前DO系统的局限性，包括其半埋藏式设计和对照顾者遵循精确治疗方案的沉重依赖，该技术尚未被广泛采用。该项目将进一步开发一种新的分散注意力的技术，以解决其中的许多问题。除了最初的DO适应症外，最终应用于手术矫正阻塞性睡眠呼吸暂停和颞下颌关节(TMJ)紊乱的市场潜力至少为60亿美元。这项小型企业创新研究(SBIR)第一阶段项目将进一步开发一种新型的非接触式植入物和相关的外部驱动器，通过消除导致设备相关并发症和治疗不依从的主要途径，显著改进现有的牵张成骨(DO)手术器械。目前的护理标准包括一个穿过患者皮肤的外部组件；这是手动扩展设备所必需的。本提案中将要开发的设备组件将通过使用一种创新的设计来消除突出部件，该设计利用磁铁而不是手动操作来产生分散注意力所需的力。这不仅将消除感染的途径，还将解决与护理标准相关的许多其他限制，例如增加设备移位的风险、止痛药的使用、患者的耻辱、所需的手动操作以及治疗不依从。该项目将建立在早期概念验证工作的基础上，对一组关键尺寸不超过护理标准的设备原型进行建模、生产和测试，以严格证明它们能够满足关键性能规格；特别是它们可以提供实现新的和完全非接触式DO程序所需的分心力量。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to improve surgical outcomes for the more than 200,000 newborns worldwide who are born each year with congenital conditions that cause impaired growth of the skull or mandible. These abnormalities affect breathing, hearing, speech, visual function, neurologic development, and mastication. Current treatments for this fragile population are inherently complex and traumatic. Distraction osteogenesis (DO) is a widely recognized treatment modality for craniofacial abnormalities that harnesses the body’s natural ability to regenerate bone in order to correct skeletal deficiencies and defects. While surgeons have shown the utility of DO for restoring functional discrepancies in patients born with craniofacial differences, the technique has not been widely adopted due to limitations of current DO systems, including their semi- buried design and burdensome reliance on caregivers to follow precise treatment protocols. This project will further development of a novel distraction technique that will address many of these issues. Beyond the initial DO indication, eventual applications in surgical correction of obstructive sleep apnea and temporomandibular joint (TMJ) disorder represent an eventual market potential of at least $6 B.This Small Business Innovation Research (SBIR) Phase I project will further development of a novel contactless implant and associated external driver that will significantly improve upon current distraction osteogenesis (DO) surgical apparatus by removing a principal path to device-associated complications and treatment noncompliance. The current standard of care includes an external component that protrudes through the patient’s skin; this is required for manual expansion of the device. The device package to be developed in this proposal will eliminate the protruding component through use of an innovative design that leverages magnets instead of manual action to produce the force necessary for distraction. This will not only remove a pathway to infection but also will resolve many of the other limitations associated with the standard of care such as the increased risk of device dislodgement, analgesic use, patient stigma, required manual operation, and treatment noncompliance. This project will build on early proof-of-concept work to model, produce and then test a set of device prototypes, with critical dimensions no larger than standard of care, to rigorously demonstrate that they can meet key performance specs; in particular that they can provide the distraction force necessary to enable a new and entirely contactless DO procedure.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.