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 clinica...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.展开更多
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 capsule.The safety and...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 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 mm 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.展开更多
A novel polyolefin called poly(styrene-block-isobutylene-block-styrene)(“SIBS”)originated from Joseph P.Kennedy’s laboratory at the University of Akron(Akron,Ohio,United States)and was developed as a biomaterial fo...A novel polyolefin called poly(styrene-block-isobutylene-block-styrene)(“SIBS”)originated from Joseph P.Kennedy’s laboratory at the University of Akron(Akron,Ohio,United States)and was developed as a biomaterial for long-term implant applications by the author.SIBS 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 eye.This article explores two ophthalmic devices;1)the PRESERFLO®MicroShunt(Santen Pharmaceutical Co.Ltd.,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.展开更多
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 management.Micro...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 management.Microinvasive glaucoma surgery(MIGS)procedures aim to reduce the need for intra-and post-operative management and provide a less invasive means of lowering IOP.Generally,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 glaucoma.The 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 SIBS.The lumen size is sufficiently small that at normal aqueous flow hypotony is avoided,but large enough to avoid being blocked by sloughed cells or pigment.The 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 capsule.The 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 lysis.The implantation procedure can be performed in combination with cataract surgery or as a standalone procedure.The 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 surgery.Three clinical studies assessing the long-term safety and efficacy of the MicroShunt have been completed;a Phase 3 multicenter,randomized clinical study comparing the MicroShunt to primary trabeculectomy is underway.In preliminary studies,the MicroShunt effectively reduced IOP and use of glaucoma medications up to 3 years after implantation,with an acceptable safety profile.This article summarizes current literature on the unique properties of the MicroShunt,the preliminary efficacy and safety findings,and discusses its potential use as an alternative to trabeculectomy for glaucoma surgery.展开更多
基金This research was financially supported by the Chemelot Institute for Science&Technology(InSciTe)under grant agreement BM3.03 SEAMS。
文摘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.
文摘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 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 mm 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.
文摘A novel polyolefin called poly(styrene-block-isobutylene-block-styrene)(“SIBS”)originated from Joseph P.Kennedy’s laboratory at the University of Akron(Akron,Ohio,United States)and was developed as a biomaterial for long-term implant applications by the author.SIBS 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 eye.This article explores two ophthalmic devices;1)the PRESERFLO®MicroShunt(Santen Pharmaceutical Co.Ltd.,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.
基金support was provided by Lucy Cartwright,MChem,Helios Medical Communications,Cheshire,UKfunded by Santen.MicroShunt studies were sponsored by InnFocus,a Santen company.
文摘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 management.Microinvasive glaucoma surgery(MIGS)procedures aim to reduce the need for intra-and post-operative management and provide a less invasive means of lowering IOP.Generally,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 glaucoma.The 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 SIBS.The lumen size is sufficiently small that at normal aqueous flow hypotony is avoided,but large enough to avoid being blocked by sloughed cells or pigment.The 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 capsule.The 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 lysis.The implantation procedure can be performed in combination with cataract surgery or as a standalone procedure.The 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 surgery.Three clinical studies assessing the long-term safety and efficacy of the MicroShunt have been completed;a Phase 3 multicenter,randomized clinical study comparing the MicroShunt to primary trabeculectomy is underway.In preliminary studies,the MicroShunt effectively reduced IOP and use of glaucoma medications up to 3 years after implantation,with an acceptable safety profile.This article summarizes current literature on the unique properties of the MicroShunt,the preliminary efficacy and safety findings,and discusses its potential use as an alternative to trabeculectomy for glaucoma surgery.
