SBIR Phase II: Miniaturization of a Magnetic Craniofacial Distraction System

这个小型企业创新研究（SBIR）第二阶段项目的更广泛的影响/商业潜力是第一个完全植入式皮下系统，用于治疗20万名先天性疾病导致颅骨或下颌骨生长受损的婴儿。这些异常影响基本功能，包括呼吸、听力、言语、视觉功能、神经发育和咀嚼。牵引成骨（DO）是一种广泛认可的颅面畸形的临床治疗方法，通过利用身体再生骨的自然能力，施加受控的机械力来纠正骨骼缺陷和缺损。目前的半外部化机械设计系统恢复了功能差异，但导致患者舒适度和不良事件的问题，这些问题依赖于护理人员遵循阻碍广泛采用的精确治疗方案。该项目旨在为颅颌面（CMF）骨骼开发第一个完全皮下自动DO系统。其应用包括成人阻塞性睡眠呼吸暂停和颞下颌关节（TMJ）紊乱的手术矫正，潜在市场超过100亿美元。该小型企业创新研究（SBIR）第二阶段项目将生产一种新型的完全植入式颅面牵引系统，该系统由植入式磁力驱动机制和外部控制器驱动器组成。该系统旨在通过使用新型植入式磁性驱动器设计移除突出患者皮肤的外部组件，从而显著改善现有牵引成骨手术设计。该新型设计能够手动机械调节器械，能够以安全可靠的方式提供必要的牵引力，同时消除并发症和治疗不依从性的主要途径。拟定受益将降低感染、器械脱位、镇痛剂使用、患者耻辱、需要手动操作和治疗不依从性的风险。本项目旨在降低关键的关键剩余工程设计风险，包括临床使用和可制造性之前的系统可用性问题。该项目完成后，原型将在临床前模型中进行体内测试，然后再用于人体。该奖项反映了NSF的法定使命，并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，被认为值得支持。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is the first fully implantable, subcutaneous system for treating 200,000 infants born with congenital conditions causing impaired growth of the skull or mandible. These abnormalities affect basic functions including breathing, hearing, speech, visual function, neurologic development, and mastication. Distraction Osteogenesis (DO) is a widely recognized clinical treatment for craniofacial abnormalities that applies controlled mechanical forces to correct skeletal deficiencies and defects by leveraging the natural ability of the body to regenerate bone. Current semi-externalized mechanical design systems restore functional discrepancies but result in issues with patient comfort and adverse events that rely on caregivers to follow precise treatment protocols that hinder widespread adoption. This project aims to develop the first fully subcutaneous, automated DO system for the craniomaxillofacial (CMF) skeleton. Applications include surgical correction of obstructive sleep apnea and temporomandibular joint (TMJ) disorder in the adult population, representing potential markets exceeding $10 billion. This Small Business Innovation Research (SBIR) Phase II project will produce a novel, fully implantable craniofacial distraction system comprised of an implantable, magnetically driven mechanism and an external controller driver. The system aims to significantly improve upon existing distraction osteogenesis surgical designs by removing an external component that protrudes through the patient’s skin using a novel implantable magnetic driver design. The novel design enables manual mechanical device adjustment capable of providing the necessary distraction forces in a safe and reliable manner, while eliminating the principal path of complications and treatment noncompliance. The proposed benefits would reduce the risks of infection, device dislodgement, analgesic use, patient stigma, required manual operation, and treatment noncompliance. This project aims to reduce the key critical remaining engineering design risks including system usability issues prior to clinical use and manufacturability. Upon completion of the project, the prototypes will undergo in vivo testing in preclinical models prior to human use.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.