SBIR Phase I: Miniaturization of a Magnetic Craniofacial Distraction System

这个小企业创新研究（SBIR）第一阶段项目更广泛的影响/商业潜力是改善全球每年超过200，000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骨生长受损的先天性疾病。 这些异常影响呼吸、听力、言语、视觉功能、神经发育和咀嚼。 目前对这一脆弱人群的治疗本质上是复杂和创伤性的。牵张成骨（DO）是一种广泛认可的颅面畸形治疗方式，利用身体的天然能力再生骨，以纠正骨骼缺陷和缺陷。虽然外科医生已经显示了DO用于恢复出生时具有颅面差异的患者的功能差异的实用性，但是由于当前DO系统的限制，包括其半埋式设计和对护理人员的繁重依赖以遵循精确的治疗方案，该技术尚未被广泛采用。该项目将进一步开发一种新的分心技术，将解决许多这些问题。除了初始DO指示之外，最终应用于阻塞性睡眠呼吸暂停和颞下颌关节（TMJ）紊乱的手术矫正，代表了至少60 B美元的最终市场潜力。该小型企业创新研究（SBIR）第一阶段项目将进一步开发一种新型非接触式植入物和相关的外部驱动器，这将显著改善当前的牵张成骨（DO）通过去除与装置相关的并发症和治疗不依从性的主要路径， 目前的护理标准包括一个突出患者皮肤的外部组件;这是手动扩张器械所需的。本提案中开发的器械包装将通过使用创新设计消除突出组件，该设计利用磁铁而不是手动操作来产生牵引所需的力。 这不仅将消除感染途径，还将解决与标准治疗相关的许多其他限制，例如器械脱位风险增加、止痛剂使用、患者污名、需要手动操作和治疗不依从性。 该项目将建立在早期概念验证工作的基础上，对一套关键尺寸不大于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;特别是他们能够提供必要的分散注意力的力量，使一种新的、完全非接触式的DO程序成为可能。这个奖项反映了NSF的法定使命，并且被认为是值得支持的通过使用基金会的知识价值和更广泛的影响审查标准进行评估。

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.