Fibrosis-Resistant Bleb-Free Gaucoma Implant
抗纤维化无泡青光眼植入物
基本信息
- 批准号:8713342
- 负责人:
- 金额:$ 20.65万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2014
- 资助国家:美国
- 起止时间:2014-05-01 至 2015-12-31
- 项目状态:已结题
- 来源:
- 关键词:AddressAdoptionAqueous HumorAreaBiocompatibleBiocompatible MaterialsBlindnessBlood capillariesBullaClinicalClinical ResearchClinical TrialsComplicationCytoplasmic GranulesDataDevicesDiffusionDrainage procedureEyeFailureFibrosisFiltrationGeometryGlaucomaGoalsHeadHealthImplantInfectionLegal patentLiquid substanceMarketingMedicalModelingOperative Surgical ProceduresOptic NerveOryctolagus cuniculusPerformancePhasePhysiologic Intraocular PressurePoriferaPrevalenceResistanceRiskSafetyShapesSiliconesSiteSmall Business Innovation Research GrantSodium ChlorideSolutionsStructureSurfaceSystemTechniquesTestingTissuesVascularizationanterior chamberaqueousbasebiomaterial developmentcapillaryclinical applicationcommercializationcomparative efficacydesignimplantable deviceimprovedinnovationnext generationnovelpost-marketpressureprogramsresearch clinical testingresponse
项目摘要
DESCRIPTION (provided by applicant): The objective of this Phase I SBIR project is to test the feasibility of using a novel biomaterial design for improved Glaucoma Drainage Device (GDD) performance. The proposed innovation has the eventual aim to enhance our current STARfloTM Glaucoma Implant device by increasing its drainage efficiency with a fibrosis-minimizing surface geometry. This could allow use of a smaller implant and simplify placement surgery. Significance: Glaucomatous eyes usually have impeded drainage systems, causing intraocular pressure (IOP) to build, damaging the optic nerve and leading to blindness. GDDs are increasingly relied on as a surgical approach to reduce IOP. The established GDD paradigm depends on maintaining a permanent subconjunctival filtering bleb, with risks of bleb leaks and infection, and of fibrosis-related bleb-failure. An efficient, low-fibrosis, bleb-independent GDD with low complication rate would have a major impact. Innovation: STARfloTM is a new GDD comprised entirely of Healionics' proprietary STAR® biomaterial, a precision microporous structure of biocompatible silicone geometrically optimized to reduce fibrosis and induce ingrowth of a dense capillary network from the surrounding tissue, obviating formation of a bleb. This drainage mechanism, soft sponge design, and fibrosis- resistant pore geometry give it several advantages over competing GDDs. It has CE Mark approval, and early clinical results are promising. To enable a less-invasive smaller STARflo device, we propose to further improve drainage efficiency by forming the porous structure with a heavily textured surface. We have demonstrated that such a geometry, comprising surface-adhered granules of STAR biomaterial, gives a further remarkable reduction in fibrotic encapsulation. To closely approximate the granular surface in a continuously microporous form suitable for a GDD, we will apply a double templating technique using pyramidal salt crystals. Approach: The target Milestones - to be achieved in a rabbit model - are: 1) histological evidence that texturing reduces fibrosis in the suprachoroidal site, 2) evidence that texturing improves IOP-lowering performance for a given size implant, and 3) demonstration that a smaller and less invasive textured device can deliver equivalent IOP-lowering performance to the current larger STARflo implant. A follow on Phase II would leverage the commercialization and regulatory momentum of the current STARflo device by advancing the new design into a pilot clinical study.
描述(由申请方提供):本I期SBIR项目的目的是测试使用新型生物材料设计改善青光眼引流装置(GDD)性能的可行性。提出的创新的最终目标是通过增加其引流效率和纤维化最小化的表面几何形状来增强我们目前的STARfloTM青光眼植入装置。这可以允许使用更小的植入物并简化放置手术。重要性:青光眼的眼睛通常有排水系统受阻,导致眼内压(IOP)建立,损害视神经,导致失明。越来越多地依赖GDD作为降低IOP的手术方法。已建立的GDD模式依赖于维持永久性结膜下滤过泡,存在滤过泡渗漏和感染以及纤维化相关滤过泡衰竭的风险。一种有效的、低纤维化的、不依赖于滤过泡的GDD,并发症发生率低,将产生重大影响。创新:STARfloTM是一种全新的GDD,完全由Healionics专有的星星®生物材料组成,这是一种生物相容性硅胶的精密微孔结构,经过几何优化,可减少纤维化并诱导周围组织的致密毛细血管网络向内生长,避免形成水泡。这种引流机制、软海绵设计和抗纤维化孔隙几何形状使其具有优于竞争GDD的几个优势。它已获得CE认证,早期临床结果很有希望。为了实现更小的微创STARflo器械,我们建议通过形成具有重度纹理表面的多孔结构来进一步提高引流效率。我们已经证明,这样的几何形状,包括表面粘附颗粒的星星生物材料,给出了进一步显着减少纤维化封装。为了以适合于GDD的连续微孔形式紧密地近似颗粒表面,我们将应用使用锥形盐晶体的双模板技术。方法:在家兔模型中实现的目标Milestone是:1)组织学证据表明毛面处理可减少脉络膜上腔部位的纤维化,2)毛面处理可改善给定尺寸植入物的降IOP性能的证据,3)证明较小且侵入性较小的毛面器械可提供与当前较大STARflo植入物等同的降IOP性能。第二阶段的后续工作将通过将新设计推进到试点临床研究中来利用当前STARflo设备的商业化和监管势头。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Andrew Marshall其他文献
Andrew Marshall的其他文献
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{{ truncateString('Andrew Marshall', 18)}}的其他基金
Infection and Thrombosis Resistant Needle-Free Hemodialysis Access Port and Graft Using STAR Biomaterials
使用 STAR 生物材料的抗感染和血栓形成无针血液透析接入端口和移植物
- 批准号:
9251877 - 财政年份:2015
- 资助金额:
$ 20.65万 - 项目类别:
Product and Regulatory Development of a Needle-Free Hemodialysis Access Port
无针血液透析接入端口的产品和法规开发
- 批准号:
9752212 - 财政年份:2015
- 资助金额:
$ 20.65万 - 项目类别:
Product and Regulatory Development of a Needle-Free Hemodialysis Access Port
无针血液透析接入端口的产品和法规开发
- 批准号:
10016390 - 财政年份:2015
- 资助金额:
$ 20.65万 - 项目类别:
Product and Regulatory Development of a Needle-Free Hemodialysis Access Port
无针血液透析接入端口的产品和法规开发
- 批准号:
10202696 - 财政年份:2015
- 资助金额:
$ 20.65万 - 项目类别:
Infection and Thrombosis Resistant Needle-Free Hemodialysis Access Port and Graft Using STAR Biomaterials
使用 STAR 生物材料的抗感染和血栓形成无针血液透析接入端口和移植物
- 批准号:
9031805 - 财政年份:2015
- 资助金额:
$ 20.65万 - 项目类别:
Biointegrating Dialysis Access Graft with Self Stabilizing Flow
具有自稳定流的生物整合透析通路移植物
- 批准号:
9142347 - 财政年份:2014
- 资助金额:
$ 20.65万 - 项目类别:
Biointegrating Dialysis Access Graft with Self Stabilizing Flow
具有自稳定流的生物整合透析通路移植物
- 批准号:
9319741 - 财政年份:2014
- 资助金额:
$ 20.65万 - 项目类别:
Vascular Grafts for Needle Free Dialysis Access Devices.
用于无针透析接入装置的血管移植物。
- 批准号:
8781609 - 财政年份:2014
- 资助金额:
$ 20.65万 - 项目类别:
Biointegrating Dialysis Access Graft with Self Stabilizing Flow
具有自稳定流的生物整合透析通路移植物
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9048990 - 财政年份:2014
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8311585 - 财政年份:2010
- 资助金额:
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