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 视网膜疾病是导致视力下降的常见原因。包括视网膜在内的许多病症 黄斑脱离和黄斑裂孔，唯一的治疗方法是手术。所有这类手术的第一步是玻璃体切除， 通过眼球前部的微小孔道去除玻璃体凝胶的过程。每年，110万人 玻璃体切除手术在全球范围内进行，仅在美国就有30万例，而且在大多数情况下 视网膜填塞需要留在眼睛里，以保持对视网膜的压力，并帮助愈合。《环球报》 视网膜填充物市场在2013年的估值为6450万美元，预计将达到77.5美元 到2020年将达到100万。 目前的技术水平是使用可膨胀的气体或硅油在视网膜上施加压力 愈合(填塞)。然而，这两种方法都不是理想的，因此为了解决这些缺陷，这 Proposal开发了一种新型水凝胶，它使用两种常见的合成生物医学聚合物，即改性的 聚(乙烯醇)和聚乙二醇的形式，创造了一种独特的水凝胶体系，这种体系非常低 粘度以液体形式存在，但随后通过在眼睛中形成交联剂而形成凝胶。这种制剂允许注射。 通过小的手术端口，然后在体内扩张，导致360度的视网膜填塞。这个独一无二的 配方将消除术后患者定位的需要。此外，这种水凝胶会降解 在3-5周的时间内提供临时填充力，然后降解为 容易从眼睛中清除，从而消除了后续手术移除填充物的需要 探员。由此产生的设备将更加患者友好，几乎没有屈光问题，并能够 病人要充分活动。因此，患者的依从性将得到改善。此外，它还将作为一个 仅对与手术相关的时间段进行填塞，然后通过降解过程自然清除 降低成本，改善结果。