InnFocus, Inc., Miami, FL, USA;; Ophthalmic Biophysics Center, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, FL, USA;
Pôle Ophtalmologique De La Clinique Mutualiste, Pessac Cedex, France;
Regen Biomater. 2016 Jun;3(2):137-42. doi: 10.1093/rb/rbw005. Epub 2016 Feb 25.
The InnFocus MicroShunt® is a minimally invasive glaucoma drainage microtube used to shunt aqueous humor from the anterior chamber of the eye to a flap formed under the conjunctiva and Tenon's capsule. The safety and clinical performance of this device approaches that of trabeculectomy with mitomycin C, the current 'gold standard' treatment for advanced glaucoma. The invention of a new biomaterial called poly(styrene-block-isobutylene-block-styrene) or 'SIBS' is the enabling factor which led to the success of this product. SIBS is ultrastable with virtually no foreign body reaction in the body, which manifests as clinically insignificant inflammation and capsule formation in the eye. The lack of capsule formation enables unobstructed flow through the 70 µm lumen tube and the achievement of controlled low intraocular pressure, which is important for the management of glaucoma. This article summarizes the integration of SIBS into a glaucoma drainage device and confirms its functionality with clinical success over a 2-year period.
InnFocus MicroShunt® 是一种微创青光眼引流微管,用于将房水从前房引流至结膜和 Tenon 囊下形成的瓣下。该装置的安全性和临床性能接近丝裂霉素 C 小梁切除术,这是目前治疗晚期青光眼的“金标准”治疗方法。一种名为聚苯乙烯-异丁烯-聚苯乙烯或“SIBS”的新型生物材料的发明是该产品成功的关键因素。SIBS 具有超高的稳定性,在体内几乎没有异物反应,表现为临床上无明显的炎症和囊形成。囊的形成缺失使得 70 µm 管腔的流动不受阻碍,并且能够实现受控的低眼内压,这对于青光眼的管理很重要。本文总结了将 SIBS 整合到青光眼引流装置中的情况,并通过 2 年的临床成功确认了其功能。