A Smart, Fully Subcutaneous Distraction System to Improve Outcomes in Patients with Congenital or Acquired Craniofacial Differences

摘要/摘要 每年，全世界约有20万新生儿患有此病，其中80%-85%需要手术治疗 导致头骨或下颌骨发育受损的先天性疾病，导致影响 呼吸、听力、言语、视觉功能、神经发育和咀嚼。不幸的是，目前 外科治疗，包括内窥镜手术、开放重建和牵引成骨(DO)， 遭受固有的缺陷，影响结果。对于这一脆弱的患者群体，需要一个更好的解决方案。 DO是一种被广泛认可的治疗方式，它利用身体的自然能力在 以纠正骨骼缺陷和缺陷。虽然仍在颅颌面(CMF)应用中出现， 外科医生已经证明了DO在修复颅面部疾病患者功能差异方面的效用 不同之处。DO的技术包括手术放置一个或多个牵引器，这些牵引器是设备 用来在截骨部位慢慢地分开两个相对的骨头碎片，以逐渐延长和重塑 并刺激新的骨骼生长。然而，做并不是没有缺点的。首先，都是最新的 牵引器有一个外部组件，可用于手动扩展。外部组件显著增加 患者出现并发症的风险，如感染(35%)、装置移位(3.0%)、止痛剂使用量增加以及 瘢痕形成(15.6%)。其次，由于手动扩展的繁重责任在于照顾者， 治疗不依从性(4.7%)是一个严重的问题，导致设备不一致等各种漏洞 扩张以完成治疗失败。因此，做DO需要大量的医生临床时间和患者 放射照射监测治疗进展，因此在CMF骨骼中尚未被广泛采用 尽管人们认识到内窥镜手术(使用适应症较窄)和开放手术的潜在优势 重建(更具侵入性、更长的麻醉时间、更高的输血率、更长的住院时间)。 Ostiio分心(OD)系统作为第一个完全解决了与DO治疗相关的许多问题 用于CMF骨骼的皮下非接触式DO系统。在高水平上，OD系统利用磁力 联轴器将扭矩从手持驱动器(HHD)传递到植入物，从而将植入物扩展到 非接触式时尚。这种新的方法将显著减少感染、疤痕和操作。 不合规。此外，由于该设计独特地允许植入物之间的无线通信 和HHD，它将使医生能够更好地控制和监测治疗进展。 该提案旨在通过证明OD系统能够严格满足以下要求来验证其关键性能规格 分散注意力的性能参数与当前护理标准所达到的参数相似。成功 这一成果的展示将支持第二阶段，在该阶段中，我们将通过 在活体模型和形成性人类因素研究中验证功能和表现。这项工作将加快速度 营销一种新的CMF手术方法，可以显著改善DO患者的预后和体验。

SUMMARY / ABSTRACT Each year, ~200,000 newborns worldwide, 80-85% of whom require surgical intervention, are afflicted with congenital conditions that cause impaired growth of the skull or mandible, leading to abnormalities that affect breathing, hearing, speech, visual function, neurologic development, and mastication. Unfortunately, current surgical treatments, including endoscopic surgery, open reconstruction, and distraction osteogenesis (DO), suffer inherent drawbacks, impacting outcomes. A better solution is needed for this vulnerable patient population. DO is a widely recognized treatment modality that harnesses the body’s natural ability to regenerate bone in order to correct skeletal deficiencies and defects. While still emerging for craniomaxillofacial (CMF) applications, surgeons have shown the utility of DO for restoring functional discrepancies in patients with craniofacial differences. The technique of DO involves surgical placement of one or more distractors, which are devices used to slowly separate two opposing bony fragments at an osteotomy site, to gradually lengthen and reshape the affected bone and stimulate new bone growth. However, DO is not without shortcomings. First, all current distractors have an external component for manual expansion. The external component significantly increases patient risk for complications such as infection (35%), device dislodgement (3.0%), increased analgesic use, and scarring (15.6%). Second, since the burdensome responsibility for manual expansion lies with the caregiver, treatment noncompliance (4.7%) is a serious issue, introducing vulnerabilities ranging from inconsistent device expansion to complete treatment failure. Therefore, DO necessitates extensive physician clinic time and patient radiation exposure to monitor therapeutic progress and thus has not been widely adopted in the CMF skeleton despite recognition of potential advantages over endoscopic surgery (narrower indication for use) and open reconstruction (more invasive, longer anesthesia time, higher blood transfusion rate, longer hospital stay). The Ostiio distraction (OD) system addresses many of the issues associated with DO treatment as the first fully subcutaneous, contactless DO system for the CMF skeleton. At a high level, the OD system leverages magnetic coupling to transfer torque from the hand-held driver (HHD) to the implant, thereby expanding the implant in a contactless fashion. This novel approach will markedly reduce infection, scarring, and manipulation noncompliance. In addition, because the design uniquely permits wireless communication between the implant and HHD, it will enable physicians to better control and monitor treatment progress. This proposal aims to validate a key performance spec of the OD system by demonstrating it can rigorously meet distraction force performance parameters similar to those achieved by the current standard of care. Successful demonstration of this outcome will support Phase II in which we will further development of the OD system by validating function and performance in an in vivo model and formative human factors study. This work will speed to market a novel approach to CMF surgery that can significantly improve DO patient outcomes and experience.