Regulation of Intraocular Pressure via a Novel Adjustable Glaucoma Drainage Device

通过新型可调节青光眼引流装置调节眼压

基本信息

批准号：
10735637
负责人：
Jian Lin
金额：
$ 41.28万
依托单位：
UNIVERSITY OF MISSOURI-COLUMBIA
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-09-01 至 2025-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10735637
关键词：
Acrylates Address Affect Applications Grants Aqueous Humor Biochemical Biocompatible Materials Boron Carbomer-940 Characteristics Chronic Clinic Clinical Complication Data Development Devices Disease Drainage procedure Drug Delivery Systems Elastomers Evolution Eye Eye diseases Failure Feedback Glaucoma Glycerol Goals Image Implant In Vitro Inherited Injury Iron Laurates Liquid substance Magnetism Mechanics Memory Methods Modification Neodymium Operative Surgical Procedures Optic Nerve Oryctolagus cuniculus Patients Performance Persons Physiologic Intraocular Pressure Polymers Positioning Attribute Postoperative Period Process Property Regulation Repeat Surgery Resistance Series Shapes Shunt Device Silicones Structure Surgeon Surgical Management Technology Temperature Testing Torque Tube United States Validation Vision anterior chamber aqueous biomaterial compatibility chemical stability design elastomeric empowerment eye chamber fabrication glaucoma surgery implantable device improved in vivo in vivo evaluation intraocular aqueous flow magnetic field manufacture mechanical properties microrobot minimally invasive nerve damage novel particle phase change porcine model preservation prevent prototype response standard care translational potential trend

项目摘要

Project Summary The proposed project aims at studying regulation of aqueous outflow for controlling intraocular pressure (IOP) of eyes by developing a novel adjustable glaucoma drainage device (AGDD). The proposed function of controlling IOP is empowered by a magnetic shape memory polymer (SMP) composite (M-SMP-C) valve that is integrated within a conventional shunt silicone tube. The shape of the M-SMP-C valve can be reprogrammed on demand by external magnetic fields, thus modulating the flow resistance of aqueous humor from the anterior chamber of the eye into the subconjunctival space outside of the wall of the eye. The modulation is continuous, postoperative, and non-invasive. To achieve the goal, recent development of novel responsive materials in the PI’s group will be leveraged to develop M-SMP-C consisting of a poly(glycerol-dodecanoate) acrylate (PGDA) and polyacrylic acid (PAA) (PGDA-PAA) shape memory elastomer which has a programmed shape change at 41 ℃ and two magnetic microparticles: neodymium–iron–boron (NdFeB) and Fe3O4. The preliminary results show that the proposed material has great biocompatibility, chemical stability, and mechanical properties. This project will be carried out to validate two hypotheses: 1) the fabricated M-SMP-C valve will show desired shapes under the magnetic fields through material and structure design; 2) shape reprogramming and deployment of the valve integrated in the AGDD will result in regulation of aqueous flow for IOP control. First, we will design and synthesize M-SMP-C followed by material characterizations of their microstructures to correlate the structures with the magnetic-mechanic response properties. Then the fabricated M-SMP-C valves will be integrated with a shunt tube to make an AGDD for in vitro study. The flow characteristics across the fabricated AGDDs will be studied and compared with the results from a computational fluid dynamic study. In turn, these results will serve as feedback to improve the material design and device fabrication. Finally, we will evaluate the material biocompatibility and device performance via ex vivo and in vivo studies. If successful, this proposed technology will show unprecedented advancement to address the long-standing issues inherited in conventional GDDs for IOP management. First, a surgical option will be developed to treat glaucoma by the proposed AGDDs which can be postoperatively and non-invasively adjusted on demand. This technology will address the clinical need despite the evolution of traditional GDDs in the past 50 years and the recent advent of minimally invasive glaucoma surgery (MIGS) shunting technologies. Second, capability of continuous and reversible valve adjustment will eliminate an otherwise tenuous and challenging postoperative course, thus obviating the need for reoperations and post-hoc modifications of available GDDs. Third, the proposed AGDD is compact and shows a similar structural form to a conventional GDD, thus will be familiar to the surgeons. In summary, this technology would represent a paradigm shift in the surgical management of glaucoma, helping to preserve the vision of millions of patients affected by this disease.

项目概要拟议项目旨在研究房水流出的调节以控制眼内压通过开发新型可调节青光眼引流装置（AGDD）来改善眼睛的眼压（IOP）。磁性形状记忆聚合物 (SMP) 复合材料 (M-SMP-C) 阀可控制 IOP，该阀集成在传统分流硅胶管内 M-SMP-C 阀的形状可以重新编程。外部磁场的需求，从而调节前房房水的流动阻力眼腔进入眼壁外的结膜下空间，调制是连续的，为了实现术后和非侵入性的目标，最近开发了新型响应材料。 PI 的团队将开发由聚（甘油-十二烷酸酯）丙烯酸酯 (PGDA) 组成的 M-SMP-C 和聚丙烯酸（PAA）（PGDA-PAA）形状记忆弹性体，其在 41 ℃和两种磁性微粒：钕铁硼（NdFeB）和Fe3O4 的初步结果。表明所提出的材料具有良好的生物相容性、化学稳定性和机械性能。该项目将验证两个假设：1) 制造的 M-SMP-C 阀门将显示通过材料和结构设计在磁场下形成所需的形状；2）形状重新编程和 AGDD 中集成的阀门的部署将导致对眼压控制的水流进行调节。我们将设计和合成 M-SMP-C，然后对其微观结构进行材料表征，以然后将结构与制造的 M-SMP-C 阀相关联。将与分流管集成，形成 AGDD 用于体外研究的流动特性。将研究制造的 AGDD 并与计算流体动力学研究的结果进行比较。反过来，这些结果将作为改进材料设计和器件制造的反馈。通过离体和体内研究评估材料的生物相容性和设备性能。如果成功，这项提出的技术将显示出前所未有的进步，以解决长期存在的问题传统 GDD 治疗 IOP 所遗留的问题首先，将开发一种手术方案来治疗。青光眼所提出的 AGDD 可以根据需要进行术后非侵入性调整。尽管传统 GDD 在过去 50 年中不断发展，而且技术仍将满足临床需求最近出现的微创青光眼手术（MIGS）分流技术第二，能力。连续和可逆的瓣膜调节将消除原本脆弱和术后的挑战当然，从而避免了对可用 GDD 进行重新操作和事后修改的需要。提出的 AGDD 是紧凑的，并且显示出与传统 GDD 类似的结构形式，因此对于总之，这项技术将代表外科手术管理的范式转变。青光眼，帮助保护数百万受该疾病影响的患者的视力。