Degradable hydrogel for retinal tamponade

用于视网膜填塞的可降解水凝胶

• 批准号: 9255604
• 负责人: Gavin James Braithwaite
• 金额: $ 22.44万
• 依托单位: CAMBRIDGE POLYMER GROUP, INC.
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-01 至 2018-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9255604
• 关键词: Address; Air; Alcohols; Anatomy; Animals; Blindness; Cadaver; Data; Devices; Effectiveness; Environment; Excision; Eye; Face; Family suidae; Formulation; Gases; Gel; Hydrogels; In Vitro; Inflammation; Injection of therapeutic agent; Lead; Left; Life; Liquid substance; Macular Hole; Materials Testing; Methods; Modeling; Modernization; Nature; New Zealand; Oils; Operative Surgical Procedures; Optics; Oryctolagus cuniculus; Outcome; Pathology; Patient-Focused Outcomes; Patients; Performance; Polymers; Positioning Attribute; Postoperative Period; Process; Property; Retina; Retinal; Retinal Detachment; Retinal Diseases; Safety; Silicone Oils; Sterility; Surgeon; System; Techniques; Testing; Time; Travel; Viscosity; Vision; Visit; Vitrectomy; base; biomaterial compatibility; compliance behavior; cost; crosslink; design; efficacy testing; ethylene glycol; experimental study; healing; implantation; improved; improved outcome; in vivo; novel; pressure; repaired; safety testing; small molecule

Project Summary Retinal disorders are a common cause of debilitating vision loss. For many of these conditions, including retinal detachments and macular holes, the only treatment is surgery. The first step of all such surgeries is vitrectomy, the process of removing the vitreous gel through tiny ports in the front of the eye. Each year, 1.1 million vitrectomies are performed globally with 300,000 performed in the US alone, and in the majority of these cases a retinal tamponade is required to be left in the eye to maintain pressure on the retina and aid healing. The global retinal tamponade market was recently valued at USD $64.5 million in 2013 and is predicted to reach USD $77.5 million by 2020. The current state of the art uses either an expansile gas, or a silicone oil to exert pressure on the retina during healing (tamponade). However, neither method is ideal and therefore to address these deficiencies, this proposal develops a novel hydrogel that uses two common synthetic biomedical polymers, namely a modified poly(vinyl alcohol) and poly(ethylene glycol) in a form that creates a unique hydrogel system that is very low viscosity in liquid form but then gels through crosslink formation in the eye. This formulation allows for injection through small surgical ports followed by in vivo expansion resulting in 360-degree retinal tamponade. This unique formulation will eliminate the need for post-operative patient positioning. Additionally, this hydrogel degrades over the period of 3-5 weeks providing a temporary tamponade force before degrading to small molecules that are readily cleared from the eye, thus removing the need for subsequent surgeries to remove the tamponade agent. The resulting device will be more patient friendly with almost no refractive issues and the ability for the patient to be fully mobile. Patient compliance will therefore be improved. In addition, it will also act as a tamponade only for the surgically relevant period of time before clearing naturally through a degradation process reducing costs and improving outcomes.

项目摘要 视网膜疾病是视力丧失的常见原因。对于许多这些条件，包括视网膜 脱离和黄斑孔，唯一的治疗方法是手术。所有此类手术的第一步是玻璃体切除术， 通过眼前的微小端口去除玻璃体凝胶的过程。每年，110万 玻璃体切除术是在全球进行的，仅在美国就进行了30万，在大多数情况下， 需要将视网膜润肤膜留在眼睛中，以维持视网膜的压力并有助于愈合。全球 2013年，视网膜坦培市场最近的价值为6450万美元，预计将达到77.5美元。 到2020年。 目前的最新状态使用膨胀气或硅油在视网膜上施加压力 治愈（棉花）。但是，这两种方法都是理想的，因此要解决这些缺陷，这 提案开发了一种新型水凝胶，该水凝胶使用两种常见的合成生物医学聚合物，即修饰 聚（乙烯基醇）和聚乙二醇的形式，该形式产生了独特的水凝胶系统，该系统非常低 液态形式的粘度，但随后通过眼睛中的交联形成凝胶。这种配方允许注射 通过小型手术端口，然后体内膨胀，导致360度视网膜润肤膜。这个独特 配方将消除术后患者定位的需求。此外，该水凝胶降解 在3-5周的时间内，提供了临时的润肤力，然后退化为小分子 很容易从眼睛中清除，从而消除了随后的手术以去除棉花的需求 代理人。最终的设备将更耐心地友好，几乎没有屈光问题和能力 患者完全移动。因此，患者合规性将得到改善。此外，它也将充当 仅在通过降解过程自然清理之前，仅在手术相关的时间段内 降低成本并改善结果。