Development of MIDI-Ray Implant for Glaucoma
青光眼 MIDI 射线植入物的开发
基本信息
- 批准号:7482557
- 负责人:
- 金额:$ 10.7万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2008
- 资助国家:美国
- 起止时间:2008-04-01 至 2010-03-31
- 项目状态:已结题
- 来源:
- 关键词:AffectAnteriorAntineoplastic AgentsAreaBiocompatibleBiocompatible MaterialsBiologicalBlindnessBostonBudgetsBullaCaliberCell ProliferationCellsCharacteristicsChemicalsChronicCicatrixClinicalClinical ResearchConditionConsensusCoronaryCoronary arteryDevelopmentDevicesDiffuseDiplopiaDisease ProgressionDistalDoseDrainage procedureDrug CombinationsEquilibriumEuthanasiaExtravasationEyeFeasibility StudiesFibroblastsFibrosisFiltering SurgeryFiltrationFluorouracilGenerationsGlaucomaGlaucoma Drainage ImplantsGoalsGrantHeadHealedHeatingHigh Pressure Liquid ChromatographyHistopathologyImplantIn VitroInflammationInstitutesInterventionKineticsLeadLeftLengthLong-Term EffectsMarketingMeasuresMethodsMicrotubulesMitomycinMitosisModelingMoldsNamesNecrosisNeedlesNumbersObject AttachmentOctanolsOnset of illnessOperative Surgical ProceduresOphthalmologistOryctolagus cuniculusOutcomePaclitaxelPatientsPharmaceutical PreparationsPharmacotherapyPhasePhosphate BufferPolyethylenePolyethylenesPolymersPolypropylenesPoriferaProceduresProcessProductionPumpQualifyingRangeRateResortRiskRunningSafetySalineSamplingScleraShapesSideSilicone ElastomersSiliconesSiteSmall Business Funding MechanismsSmall Business Innovation Research GrantSmooth MuscleSolutionsSolventsStagingStainless SteelStandards of Weights and MeasuresSteelStenosisStentsSterilitySterilization for infection controlSurfaceSurgeonSurgical FlapsSyringesSystemTechniquesTestingThickTimeTissuesToxic effectTubeTweensVisual AcuityWeightWorkaging populationanalytical methodanterior chamberaqueousbasecapsulecell killingcell typeclinically significantcommercializationconceptconjunctivadaydesigndosageevaporationexperiencefallsfollow-uphealinghealth applicationimplantationin vivoisobutylenemigrationmylarnext generationnovelpre-clinicalpressurepreventrestenosissizetetrahydrofurantrendtyvekunpublished works
项目摘要
DESCRIPTION (provided by applicant): The goal of this Small Business Innovation Research Phase I project is to develop a next generation glaucoma drainage implant, called the MIDI-Ray . The MIDI-Ray name is derived from the Miami-InnFocus-Drainage- Implant ( MIDI ); the Ray comes from the fact that it resembles a Manta-Ray. The first generation device, called the MIDI-Tube , was developed by InnFocus LLC, and the Bascom Palmer Eye Institute. Its unique features include; 1) a micro tube designed using the Hagen-Poiseuille pressure flow principle that limits flow and thereby prevents hypotony, 2) a novel biomaterial called poly(styrene-block-isobutylene-block-styrene) ( SIBS ) that does not form clinically significant scar tissue in the eye and 3) a combination of features 1 and 2 which provides a very atraumatic device that does not demonstrate erosion or migration and that demonstrates 100% patency at one year in the rabbit model. This first generation device demonstrated practicality in a limited clinical study; however, it was not as effective in very severe glaucoma patients without the use of the anti-metabolite drug Mitomycin-C (MMC). The use of anti-metabolites in glaucoma patients is still controversial as the long-term effects of these drugs vary depending upon dosage, method of application, method of rinsing out, site of application and health of the conjunctiva/Tenons and sclera. The MIDI-Ray is similar to the MIDI- Tube but incorporates a thin microplate at the distal end of the tube to prevent the subconjunctival/Tenon flap from healing closed. The goal of this grant is to determine if this new MIDI-Ray design will function in the rabbit eye with and without the use of a drug. The drug to be tested will be the antiproliferative drug paclitaxel, which is milder than MMC and does not kill cells, rather it renders them sterile. The drug will be released in a controlled manner from the MIDI-Ray microplate to eliminate variances experienced with the delivery of conventional anti-metabolite drugs that are introduced in a non-controlled manner at the time of implantation. Drainage devices may be the most effective and last resort treatment; however, they suffer from many problems. For example, currently marketed designs are made of silicone rubber and polyethylene or polypropylene which creates extensive fibrosis within the eye which can lead to reduced filtration. In addition, the plates (with their capsules) and tubes are rather large with concomitant risk of diplopia and hypotony; which often require secondary interventions such as suturelysis. The MIDI-Ray is made from an extremely soft SIBS material with a controlled filtration rate that should prevent erosion, scar tissue formation and hypotony. If it functions as anticipated, it will be effective in a wide range of patients and will be relatively simple to implant due to its small size. The biocompatible SIBS material will minimize encapsulation in the eye and the release of paclitaxel from the device will prevent the bleb from fibrosing. This is the same concept as the paclitaxel- coated coronary stent commercialized by Boston Scientific Corporation, called the TAXUS. stent (PI is the inventor), which prevents re-stenosis in the coronary arteries by limiting smooth muscle proliferation. It is expected that this simple device will provide a better option to both the glaucoma and anterior segment surgeons to effectively treat their patients in a consistent, controlled manner; hopefully at an earlier stage before visual acuity is affected. It is anticipated that Phase I testing of the device will demonstrate chemical and biological viability. Phase II will be geared toward optimization, long-term in vivo testing of the device, GLP pre-clinical testing, regulatory submissions and stepping up production for commercialization. OUBLIC HEALTH RELEVANCE: This project is sought develop an easy to implant glaucoma drainage device to treat a growing problem with the aging population which is presently the second most common cause of blindness in the U.S. This preventable blindness is treatable to some degree through aggressive drug therapy, filtering surgery and/or use of aqueous shunt implants; however, the long-term outcomes with the current products are less than desirable. The MIDI-Ray is a novel glaucoma drainage device comprised of a new biostable polymeric material that is extremely biocompatible in the eye, and has shown insignificant encapsulation as compared to silicone rubber and when combined if necessary, with an antiproliferative drug, paclitaxel, and is controllably released from it, should prevent the progression of the disease.
描述(由申请人提供):这个小型企业创新研究第一阶段项目的目标是开发下一代青光眼引流植入物,称为MIDI-Ray。MIDI- ray的名字来源于miami - infocus - drain - Implant (MIDI);之所以叫鳐,是因为它很像蝠鲼。第一代设备被称为MIDI-Tube,是由InnFocus LLC和巴斯科姆帕尔默眼科研究所开发的。其独特的特点包括;1)微管设计使用Hagen-Poiseuille压力流原则限制流量,从而防止张力减退,2)一个新颖的生物材料聚(styrene-block-isobutylene-block-styrene)(兄弟姐妹),不形成临床上重要的疤痕组织的眼睛,3)特性1和2的结合提供了一个防止损伤的设备,不侵蚀或迁移证明表明100%开放一年兔模型。第一代设备在有限的临床研究中证明了实用性;然而,在不使用抗代谢物药物丝裂霉素c (MMC)的非常严重的青光眼患者中,它的效果并不好。抗代谢物在青光眼患者中的应用仍然存在争议,因为这些药物的长期效果取决于剂量、应用方法、冲洗方法、应用部位以及结膜/腱鞘和巩膜的健康状况。MIDI- ray类似于MIDI- Tube,但在管的远端合并了一个薄的微孔板,以防止结膜下/榫瓣愈合关闭。这项拨款的目的是确定这种新的MIDI-Ray设计是否会在使用或不使用药物的情况下在兔眼中发挥作用。将要测试的药物将是抗增殖药物紫杉醇,它比MMC更温和,不会杀死细胞,而是使细胞不育。药物将以受控的方式从MIDI-Ray微孔板释放,以消除在植入时以非受控方式引入的传统抗代谢物药物递送所经历的差异。引流装置可能是最有效和最后的治疗手段;然而,他们也有很多问题。例如,目前市场上的设计是由硅橡胶和聚乙烯或聚丙烯制成的,这会在眼睛内产生广泛的纤维化,从而导致过滤减少。此外,镜板(及其胶囊)和镜管相当大,伴有复视和弱视的风险;这通常需要二次干预,如缝合术。MIDI-Ray由一种非常柔软的SIBS材料制成,过滤速度可控,可以防止侵蚀、疤痕组织形成和低斜度。如果它的功能如预期的那样,它将在广泛的患者中有效,并且由于其体积小,植入相对简单。生物相容性SIBS材料将最大限度地减少在眼睛中的封装,紫杉醇从设备中释放将防止水泡纤维化。这与波士顿科学公司商业化的紫杉醇涂层冠状动脉支架(TAXUS)的概念相同。支架(PI是发明者),通过限制平滑肌增殖来防止冠状动脉再狭窄。预期这种简单的装置将为青光眼和前节外科医生提供更好的选择,以一致、可控的方式有效地治疗患者;希望是在视力受到影响之前的早期阶段。预计该设备的第一阶段测试将证明化学和生物可行性。二期将面向优化、设备的长期体内测试、GLP临床前测试、监管提交和加快商业化生产。与公共卫生相关:该项目旨在开发一种易于植入的青光眼引流装置,以治疗人口老龄化日益严重的问题,这是目前美国第二大致盲原因。这种可预防的失明在某种程度上可以通过积极的药物治疗、过滤手术和/或使用水分流植入物来治疗;然而,当前产品的长期效果并不理想。MIDI-Ray是一种新型青光眼引流装置,由一种新的生物稳定的聚合物材料组成,与硅橡胶相比,这种材料具有极好的生物相容性,并且在必要时与抗增殖药物紫杉醇结合使用,并且可以控制其释放,应该可以防止疾病的进展。
项目成果
期刊论文数量(0)
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科研奖励数量(0)
会议论文数量(0)
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Leonard Pinchuk其他文献
Leonard Pinchuk的其他文献
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{{ truncateString('Leonard Pinchuk', 18)}}的其他基金
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$ 10.7万 - 项目类别:
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