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Ab externo implantation of the MicroShunt, a poly (styrene-block-isobutylene-blockstyrene) surgical device for the treatment of primary open-angle glaucoma: a review

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Eye and Vision 2019年第1期6卷 303-311页

作者： Omar Sadruddin Leonard Pinchuk Raymund Angeles Paul Palmberg Santen Inc EmeryvilleCAUSA. innfocus Inc. a Santen CompanyMiamiFLUSA Bascom Palmer Eye Institute University of Miami Miller School of MedicineMiamiFLUSA

Trabeculectomy remains the‘gold standard’intraocular pressure(IOP)-lowering procedure for moderate-to-severe glaucoma;however,this approach is associated with the need for substantial post-operative *** glaucoma surgery(MIGS)procedures aim to reduce the need for intra-and post-operative management and provide a less invasive means of lowering ***,MIGS procedures are associated with only modest reductions in IOP and are targeted at patients with mild-to-moderate glaucoma,highlighting an unmet need for a less invasive treatment of advanced and refractory *** PRESERFLO®MicroShunt(formerly known as innfocus MicroShunt)is an 8.5 mm-long(outer diameter 350μm;internal lumen diameter 70μm)glaucoma drainage device made from a highly biocompatible,bioinert material called poly(styrene-block-isobutylene-blockstyrene),or *** lumen size is sufficiently small that at normal aqueous flow hypotony is avoided,but large enough to avoid being blocked by sloughed cells or *** MicroShunt achieves the desired pressure range in the eye by draining aqueous humor from the anterior chamber to a bleb formed under the conjunctiva and Tenon’s *** device is implanted ab externo with intraoperative Mitomycin C via a minimally invasive(relative to incisional surgery)surgical procedure,enabling precise control of placement without the need for gonioscopy,suture tension control,or suture *** implantation procedure can be performed in combination with cataract surgery or as a standalone *** MicroShunt received ConformitéEuropéenne(CE)marking in 2012 and is intended for the reduction of IOP in eyes of patients with primary open-angle glaucoma in which IOP remains uncontrolled while on maximum tolerated medical therapy and/or in which glaucoma progression warrants *** clinical studies assessing the long-term safety and efficacy of the MicroShunt have been completed;a Phase 3 multicenter,randomized clinical study comp

关键词： Ab externo Glaucoma Micro-invasive glaucoma surgery MicroShunt Mitomycin C SIBS polymer

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The use of polyisobutylene-based polymers in ophthalmology

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Bioactive Materials 2022年第4期7卷 185-194页

作者： Leonard Pinchuk Distinguished Research Professor of Biomedical Engineering University of MiamiBiomedical Engineering Dept.13704 SW 92nd CourtMiami33176FLUnited States Founder and Senior Vice President InnFocusInc.a Santen companyMiamiFLUnited States

A novel polyolefin called poly(styrene-block-isobutylene-block-styrene)(“SIBS”)originated from Joseph ***’s laboratory at the University of Akron(Akron,Ohio,United States)and was developed as a biomaterial for long-term implant applications by the *** has no cleavable groups on its backbone or sidechains,is comprised predominantly of alternating secondary and quaternary carbons on its backbone,which prevents embrittlement and cracking under flexion,and undergoes multiple purification steps which renders it extremely biocompatible and well-suited for long-term applications in the *** article explores two ophthalmic devices;1)the PRESERFLO®MicroShunt(Santen Pharmaceutical ***.,Osaka,Japan)made from SIBS that lowers intraocular pressure to thwart progression of vision loss from glaucoma,and 2)a novel intraocular lens(IOL)made from crosslinked polyisobutylene,which is under-development by Xi’an Eyedeal Medical Technology Co.,Ltd.(Xi’an,China)that does not glisten nor cloud over time,as do most conventional IOLs.

关键词： Poly(styrene-block-isobutylene-block-styrene) SIBS Glaucoma MicroShunt Intraocular Lens IOL Polyisobutylene Cataract

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The use of poly(styrene-block-isobutyleneblock-styrene)as a microshunt to treat glaucoma

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Regenerative Biomaterials 2016年第2期3卷 137-142页

作者： Leonard Pinchuk Isabelle Riss Juan F.Batlle Yasushi P.Kato John B.Martin Esdras Arrieta Paul Palmberg Richard K.Parrish Bruce A.Weber Yongmoon Kwon Jean-Marie Parel innfocus Inc.MiamiFLUSA Ophthalmic Biophysics Center Bascom Palmer Eye InstituteUniversity of Miami Miller School of MedicineMiamiFLUSA Pôle Ophtalmologique De La Clinique Mutualiste Pessac CedexFrance Centro Laser Santo DomingoDominican Republic Anne Bates Leach Eye Hospital University of MiamiBascom Palmer Eye InstituteMiller School of MedicineMiamiFLUSA Department of Ophthalmology University of Paris Hotel-Dieu HospitalParisFrance

The innfocus MicroShuntVR 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 *** safety and clinical performance of this device approaches that of trabeculectomy with mitomycin C,the current‘gold standard’treatment for advanced *** 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 *** is ultrastable with virtually no foreign body reaction in the body,which manifests as clinically insignificant inflammation and capsule formation in the *** lack of capsule formation enables unobstructed flow through the 70 mm lumen tube and the achievement of controlled low intraocular pressure,which is important for the management of *** article summarizes the integration of SIBS into a glaucoma drainage device and confirms its functionality with clinical success over a 2-year period.

关键词： biocompatibility medical device stent soft tissue

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Magnetically actuated glaucoma drainage devicefor regulating intraocular pressure afterimplantation

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Microsystems & Nanoengineering 2023年第4期9卷 91-105页

作者： Inês C.F.Pereira Ralph J.S.van Mechelen Hans M.Wyss Leonard Pinchuk Henny J.M.Beckers Jaap M.J.den Toonder Microsystems Department of Mechanical EngineeringEindhoven University of Technology5600MB EindhovenThe Netherlands Institute for Complex Molecular Systems(ICMS) Eindhoven University of Technology5600MB EindhovenThe Netherlands University Eye Clinic Maastricht Maastricht University Medical Centre+(MUMC+)6202AZ MaastrichtThe Netherlands innfocus Inc.a Santen CompanyMiamiFlorida 33186USA Ophthalmic Biophysics Center Bascom Palmer Eye InstituteUniversity of Miami Miller School of MedicineMiamiFlorida 33136USA

The key risk factor for glaucoma is increased intraocular pressure (IOP). Glaucoma drainage devices implanted in theeye can reduce IOP and thus stop disease progression. However, most devices currently used in clinical practice arepassive and do not allow for postsurgical IOP control, which may result in serious complications such as hypotony (i.e.,excessively low IOP). To enable noninvasive IOP control, we demonstrate a novel, miniature glaucoma implant that willenable the repeated adjustment of the hydrodynamic resistance after implantation. This is achieved by integrating amagnetic microvalve containing a micropencil-shaped plug that is moved using an external magnet, thereby openingor closing fluidic channels. The microplug is made from biocompatible poly(styrene-block-isobutylene-block-styrene)(SIBS) containing iron microparticles. The complete implant consists of an SIBS drainage tube and a housing elementcontaining the microvalve and fabricated with hot embossing using femtosecond laser-machined glass molds. Usingin vitro and ex vivo microfluidic experiments, we demonstrate that when the microvalve is closed, it can providesufficient hydrodynamic resistance to overcome hypotony. Valve function is repeatable and stable over time. Due to itssmall size, our implant is a promising, safe, easy-to-implant, minimally invasive glaucoma surgery device.

关键词： enable implantation overcome

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