Fibrosis-Resistant Bleb-Free Gaucoma Implant

描述（由申请人提供）：第一阶段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。这项创新的最终目标是通过减少纤维的表面几何形状来提高引流效率，从而增强我们目前的STARfloTM青光眼植入装置。这样可以使用更小的植入物并简化植入手术。意义：青光眼通常有引流系统障碍，造成眼内压升高，损害视神经，导致失明。GDDs作为降低IOP的手术方法越来越依赖。现有的GDD模式依赖于维持永久的结膜下滤过泡，有泡漏和感染的风险，以及纤维化相关的泡衰竭。高效、低纤维化、无气泡、低并发症发生率的GDD将产生重大影响。创新：STARfloTM是一种全新的GDD，完全由Healionics专有的STAR®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，诱导周围组织的密集毛细血管网络向内生长，避免气泡的形成。这种排水机制、软海绵设计和抗纤维化孔几何形状使其优于竞争对手的GDDs。它已获得CE认证，早期临床结果令人鼓舞。为了使STARflo装置具有更小的侵入性，我们建议通过形成具有重纹理表面的多孔结构来进一步提高引流效率。我们已经证明了这种几何结构，包括表面粘附的STAR生物材料颗粒，进一步显著减少了纤维化包封。为了以适合GDD的连续微孔形式接近颗粒表面，我们将使用金字塔状盐晶体应用双模板技术。方法：目标里程碑-在兔模型中实现-是：1)组织学证据表明纹理减少脉络膜上部位的纤维化，2)证据表明纹理改善给定尺寸植入物的降低内压性能，3)证明更小，更少侵入性的纹理装置可以提供与当前更大的STARflo植入物相同的降低内压性能。第二阶段的后续研究将利用当前STARflo设备的商业化和监管势头，将新设计推进到试点临床研究。

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.