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

智能、全皮下牵引系统可改善先天性或后天性颅面差异患者的治疗效果

• 批准号: 10696721
• 负责人: Jessica DesNoyer
• 金额: $ 89.25万
• 依托单位: OSTIIO LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-14 至 2025-09-13
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10696721
• 关键词: Address; Adopted; Adoption; Affect; Analgesics; Anesthesia procedures; Animal Model; Animals; Autopsy; Bilateral; Biological; Blinded; Blood Transfusion; Bone Growth; Bone Regeneration; Bone structure; Breathing; Buffers; Caregivers; Caring; Cephalic; Cicatrix; Clinic; Clinical; Communication; Coupling; Craniofacial Abnormalities; Defect; Development; Device Designs; Devices; Distraction Osteogenesis; Ensure; Environment; Evaluation; Exhibits; Exposure to; Family suidae; Freezing; Generations; Growth; Hearing; Histologic; Home; Housing; Immersion; Impairment; Implant; Infection; Length of Stay; Liquid substance; Magnetism; Mandible; Manuals; Mastication; Measures; Miniature Swine; Modality; Monitor; Neurologic; Newborn Infant; Operative Surgical Procedures; Osteotomy; Outcome; Output; Pain; Particulate; Patient risk; Patient-Focused Outcomes; Patients; Phase; Physicians; Process; Protocols documentation; Radiation exposure; Risk; Safety; Saline; Sampling; Shapes; Site; Skeleton; Skin; Specific qualifier value; Specimen; Speech; Surgeon; System; Systems Integration; Techniques; Technology; Testing; Therapeutic; Time; Tissues; Torque; Training; Treatment Failure; Treatment Protocols; Validation; Vision; Visual; biomaterial compatibility; bone; craniofacial; craniomaxillofacial; cranium; design; distraction; effectiveness testing; experience; functional restoration; implantation; improved; improved outcome; in vivo; manufacture; non-compliance; novel strategies; operation; patient population; performance tests; prevent; prototype; reconstruction; remote monitoring; seal; skeletal; stem; subcutaneous; success; wireless communication

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 system addresses many of the issues associated with DO treatment as the first fully subcutaneous, programmable DO system for the CMF skeleton. At a high level, the Ostiio distraction 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 Phase II proposal aims to a) achieve design freeze of the integrated Ostiio distraction system, incorporating design improvements to ensure device biocompatibility and functionality throughout active distraction, and b) demonstrate the system can be used safely and effectively to perform a complete distraction protocol in vivo in standard animal model. Successful demonstration of this outcome will satisfy key validation performance testing requirements for FDA submission and 510(k) clearance and open a path to widespread clinical adoption.

总结/摘要 每年，全世界约有200，000名新生儿，其中80-85%需要手术干预， 导致颅骨或下颌骨生长受损的先天性疾病，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 手术治疗，包括内窥镜手术、开放性重建和牵张成骨（DO）， 存在固有缺陷，影响结果。需要为这些脆弱的患者群体提供更好的解决方案。 DO是一种被广泛认可的治疗方式，它利用身体的天然能力来再生骨， 以纠正骨骼缺陷和缺陷。虽然颅颌面（CMF）应用仍然新兴， 外科医生已经证明了DO在恢复颅面畸形患者的功能差异方面的实用性， 差异DO技术涉及手术放置一个或多个牵张器， 用于在截骨部位缓慢分离两个相对的骨碎片，以逐渐延长和重塑 并刺激新骨生长。然而，DO并非没有缺点。首先，所有当前 牵引器具有用于手动扩展的外部部件。外部成分显著增加 患者并发症风险，如感染（35%）、器械脱位（3.0%）、镇痛剂使用增加，以及 瘢痕（15.6%）。其次，由于手动扩展的繁重责任在于护理人员， 治疗不依从性（4.7%）是一个严重问题，会带来设备不一致等漏洞 扩张至完全治疗失败。因此，DO需要大量的医生门诊时间和患者 辐射暴露以监测治疗进展，因此尚未在CMF骨架中广泛采用 尽管已经认识到与内窥镜手术（适应症较窄）和开放手术相比的潜在优势， 重建（更具侵入性，麻醉时间更长，输血率更高，住院时间更长）。 Ostiio牵引系统解决了与DO治疗相关的许多问题， CMF骨骼的皮下可编程DO系统。在高水平上，奥斯蒂奥分散系统 利用磁耦合将扭矩从手持式驱动器（HHD）传递到植入物，从而 以非接触方式扩张植入物。这种新的方法将显着减少感染，疤痕， 操纵不依从。此外，由于该设计独特地允许无线通信， 植入物和HHD，它将使医生能够更好地控制和监测治疗进展。 该第二阶段提案旨在a）实现集成Ostiio牵引系统的设计冻结， 设计改进，以确保器械在主动牵引过程中的生物相容性和功能性，以及B） 证明该系统可安全有效地用于在体内执行完整的牵引方案， 标准动物模型。此结果的成功证明将满足关键确认性能测试 FDA提交和510（k）许可的要求，并为广泛的临床采用开辟了道路。