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.

摘要 /摘要 每年，全世界约有20万名新生儿，其中80-85％需要手术干预，遭受 导致头骨或下颌增长受损的先天性状况，导致异常影响 呼吸，听力，语音，视觉功能，神经系统发育和咀嚼。不幸的是，目前 手术治疗，包括内窥镜手术，开放重建和分心成骨（DO）， 遭受固有的缺点，影响结果。这个脆弱的患者人群需要更好的解决方案。 做是一种广泛认可的治疗方式，它利用了人体在 为了纠正骨骼缺陷和缺陷。虽然仍在出现颅颌面（CMF）应用程序时，但 外科医生表明了DO的实用性用于恢复颅面患者的功能差异 差异。 DO的技术涉及一个或多个干扰因素的手术放置，这些干扰器是设备 用于在截骨部位缓慢分离两个相对的骨片段，以逐渐延长和重塑 影响骨骼并刺激新的骨骼生长。但是，做并非没有缺点。首先，全部 干扰器具有用于手动扩展的外部组件。外部组件显着增加 患者发生并发症的风险，例如感染（35％），设备披露（3.0％），镇痛使用增加和 疤痕（15.6％）。其次，自从护理人员对手动扩张的责任在于看护人， 治疗违规（4.7％）是一个严重的问题，引入了漏洞，从不一致的设备不一致 扩展以完成治疗失败。因此，需要大量的物理诊所时间和患者 辐射暴露于监测热进度，因此在CMF骨架中尚未广泛采用 尽管认识到潜在的优势比内窥镜手术（使用较窄的指示）并打开 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分心系统解决了与Do治疗相关的许多问题 皮下，可编程的CMF骨架系统。在高水平上，Ostiio分心系统 利用磁耦合将扭矩从手持驱动器（HHD）传递到植入物 以非接触式方式扩展植入物。这种新颖的方法将显着减少感染，疤痕和 操纵不合规。此外，由于设计独特地允许在 植入物和HHD，它将使医生能够更好地控制和监测治疗的进度。 该第二阶段提案旨在a）冻结综合ostiio干扰系统的设计，并结合 设计改进，以确保设备生物相容性和功能整个主动分散注意力，b） 证明该系统可以安全有效地使用体内执行完整的分散注意力协议 标准动物模型。成功证明此结果将满足关键验证绩效测试 FDA提交和510（k）清算的要求，并打开了宽度临床采用的途径。