A Photochemically 3D Printed High-Resolution Biodegradable Suture Retention Clip

摘要：该SBIR第一阶段项目的目标是演示创建3D打印的可行性， 生物合成叉状锚夹，以克服与大缝合结相关的问题(来自#5的结 缝合、胶带缝合和网状缝合)。目前大的缝合线结有皮肤侵蚀、触觉、疼痛、疤痕形成的风险， 感染，甚至可能需要再次手术缝合脓肿。用一个小得多的设备代替打结 它的表面积与结相似，但体积要小得多，没有空隙供细菌生长 更好的安全状况将对手术产生重大影响。大的缝合线通常用于肌腱。 修复皮肤较薄的部位，如跟腱、肩袖或膝盖，以及腹壁重建。 与竞争对手的锚固技术(如钉书钉、开瓶器、大头钉和带子)相比，叉形锚具- 夹子有几个优点：它可以承受超过竞争设备强度的软组织负荷，以及 叉形锚夹在使用时不会损伤筋膜。叉形锚夹更容易和更快地 应用而不是打结，其直观的设计很容易融入临床实践。 除了该项目的手术好处外，我们还将创造第一个商业化的可生物降解性高 3D打印制造的分辨率医疗设备。本提案中使用的专有共交联剂将 创造一种新型的PPF树脂，然后可以通过数字光处理进行3D打印。这项革命性的新技术 PPF材料可用于制造具有微特征的医疗器械，这些微特征最终将被 尸体。这将不同于任何其他3D打印生物医学设备。 通过我们的多学科合作，我们将：优化3D打印的PPF配方并确认 叉形锚夹的设计阈值已达到；3D打印PPF叉形锚夹的特性 在台式测试中：机械性能；体外降解率；感染潜力；以及临床 在身体组织模型中的相关缝合保持性能；最后，展示了PPF叉形锚固- 与A相比，CLIPS对猪的生物结合、炎症和体内降解有适当的反应 谓词装置，根据食品和药物管理局的指导文件ISO 10993。在这项提案完成后，我们将拥有 建立了制造和性能验证点；演示了PPF叉形锚夹是 胜过笨重的结。在后续的第二阶段SBIR提交中，我们将完成验证和验证 试验、包装和灭菌、毒性试验、国际标准化组织10993-医疗器械试验的生物评价 以及FDA 510(K)批准的II类设备的慢性猪研究。一种可生物降解材料的研制 提高锚固强度和减少炎症的固定装置在医疗器械领域中迫切需要 软组织修复和所提出的材料在可植入设备领域具有更广泛的意义。

Abstract: The goal of this SBIR Phase I project is to demonstrate the feasibility of creating a 3D printed, biosynthetic Pronged Anchor-Clip to overcome the problems associated with large suture knots (knots from #5 suture, tape suture, and mesh suture). Currently large suture knots risk skin erosion, palpability, pain, scarring, infection, and may even require re-operation for suture abscess. Replacing a knot with a much smaller device that has a similar surface area as a knot but a much smaller volume without interstices for bacterial growth and a better safety profile would have a significant impact in Surgery. Large sutures are typically used for tendon repair in thin skinned areas such as achilles, rotator cuff, or knee, and for abdominal wall reconstruction. Compared to competing anchoring technologies (e.g. staple, corkscrew, tack, and strap) the Pronged Anchor- Clip has several advantages: it withstands soft-tissue loads exceeding the strength of competing devices and the Pronged Anchor-Clip does not injure fascia when applied. The Pronged Anchor-Clip is easier and faster to apply than tying a knot, and its intuitive design fits easily into clinical practice. In addition to the surgical benefits of the project, we will create the first commercial biodegradable high- resolution medical device manufactured by 3D printing. The proprietary co-crosslinker used in this proposal will create a novel PPF resin that can then be 3D printed through digital light processing. This revolutionary new PPF material can be used to create medical devices with micro-features that will eventually be resorbed by the body. This would be unlike any other 3D printed biomedical device. Through our multi-disciplinary collaboration, we will: optimize PPF formulations for 3D printing and confirm design thresholds for the Pronged Anchor-Clip are met; characterize the 3D printed PPF Pronged Anchor-Clips in benchtop testing for: mechanical properties; in vitro degradation rates; potential for infection; and clinically relevant suture retention performance in cadaver tissue models; and lastly, demonstrate PPF Pronged Anchor- Clips respond appropriately for bioincorporation, inflammation, and in vivo degradation in swine relative to a predicate device, per FDA guidance document ISO 10993. At the completion of this proposal we will have established manufacturing and performance proof points; demonstrating the PPF Pronged Anchor-Clip is superior to a bulky knot. In a follow-on Phase II SBIR submission, we will complete validation and verification testing, packaging and sterilization, toxicity testing, ISO 10993-Biological Evaluation of Medical Devices testing and a chronic swine study for FDA 510(k) clearance of the class II device. Development of a biodegradable fixation device with enhanced anchoring strength and reduced inflammation is urgently needed in the field of soft-tissue repair and the proposed material has broader implications in the field of implantable devices.